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Joint replacement: What’s new in 2020
MAUI, HAWAII – Outpatient total hip and knee replacement is “the latest craze” in orthopedic surgery, and it’s being driven by the might of Medicare, William Bugbee, MD, said at the 2020 Rheumatology Winter Clinical Symposium.
“In 2019, Medicare took total knee replacement off the inpatient-only list, meaning you could do it as an outpatient. And just in January 2020, they took total hips off that list. So I have to designate most of my hip and knee replacements as outpatients, even if I do it in the hospital and keep them for 1 night. And some of the private insurers have already gone to that, so they’ll deny coverage if I say I want a 1-day hospital stay, believe it or not,” according to Dr. Bugbee, chief of joint reconstruction in the department of orthopedics at the Scripps Clinic in La Jolla, Calif.
He provided a behind-the-scenes look at contemporary trends in joint replacement as well as tips on how rheumatologists can best help their patients get through the experience with excellent outcomes.
Joint replacement remains the best treatment for advanced arthritis of the hips and knees, he said. There is a high degree of confidence about the predictability and durability of the results. But joint replacement has become highly commoditized.
“We’re getting pummeled by Medicare to make this as cheap as possible,” the orthopedic surgeon explained. “An implant costs the hospital $3,000-$6,000. A care episode for a primary total joint replacement should cost a hospital $8,000-$15,000, which is about what Medicare pays for the [Diagnosis Related Group], so the margins are small. That’s why we’re being drilled on about how much we spend on every little thing. We hardly do any labs, x-rays, anything.”
As a result of recent advances in pre-, peri-, and postoperative management, outpatient joint replacement has become a safe and comparatively economical option for generally healthy patients.
“We’ve engineered a much better patient experience, so the assault and battery of 5, 10, 15 years ago isn’t so bad anymore,” Dr. Bugbee said.
Rheumatologists can expect to see a growing number of their patients undergoing total knee or hip replacement at outpatient surgery centers. That’s not a bad thing so long as the procedure is being done there because the outpatient center employs best practices in order to provide a highly efficient episode of care supported by excellent outcome data, he continued.
State-of-the-art perioperative management in 2020 includes accelerated-care pathways that allow ambulation within an hour or 2 after surgery along with same-day discharge, regional anesthesia with motor-sparing nerve blocks, and multimodal pain management with avoidance of intravenous narcotics except in opioid-tolerant patients. Tranexamic acid is now widely used in order to reduce operative blood loss.
“When I started practice 25 years ago, 50% of patients got a blood transfusion. I haven’t given a blood transfusion to a patient in probably 2 years. Tranexamic acid reduces blood loss by 500-700 cc with no discernible adverse effects. It’s truly remarkable,” he said.
Another important technical advance has been the routine use of oral dexamethasone. “Decadron is an antiemetic, it has anti-inflammatory effects, and it makes people happy. It’s a simple, cheap drug that has revolutionized care,” the surgeon continued.
Postoperative management has been streamlined. Dr. Bugbee is among many orthopedic surgeons who no longer routinely prescribe therapist-directed formal physical therapy for total hip arthroplasty patients, relying instead upon online tools and apps for self-administered physical therapy. Pedal exercise devices available online for $30 or so have been shown to be as effective as supervised physical therapy for knee rehabilitation.
What patients want to know about joint replacement
The question patients most often ask both their referring physician and the orthopedic surgeon is, “How long will my joint replacement last?” The best available data come from a couple of recent paired meta-analyses. The investigators reported 82% implant survivorship 25 years after primary total knee arthroplasty and 70% after unicondylar knee arthroplasty as well as a 25-year implant survivorship rate of 77% for total hip arthroplasty.
“I expected that hip arthroplasty survivorship rate to be much higher than 77%. The reason it’s not is probably because of the metal-on-metal bearing surface debacle of about 10 years ago. There’ve been lots of revisions because of that. We thought metal-on-metal implants were going to be all that, with microscopically low wear, but they turned out to be a nightmare because of metal ion release,” Dr. Bugbee observed.
The long-term joint survivorship data are based upon older implants. Encouraging albeit still preliminary data suggest contemporary implants may last significantly longer. The “clear winner,” he said, is a 36-mm ceramic head and a highly crosslinked polyethylene liner.
“That’s been a game changer, with a 10- to 20-fold decrease in wear compared to plastics for weight-bearing surfaces,” Dr. Bugbee said.
In terms of functional improvement, by various measures 85%-97% of patients are satisfied with the results of their total hip replacement, and 60% report returning to high-level recreational activities. Patient satisfaction scores are lower – 75%-90% – after total knee arthroplasty.
“The total knee replacement just doesn’t work like a regular joint,” the surgeon observed. “When I think of hip and knee replacements, I think of a hip as a Ferrari – it’s a high-performance joint replacement – and I think of the knee as a Ford – it’s serviceable, it does the job, and it’s okay but not fantastic.”
How referring physicians can optimize preoperative management and long-term follow-up
Orthopedic surgeons would appreciate help from rheumatologists and primary care physicians in preoperatively addressing the known modifiable risk factors for poor outcomes of joint replacement. These include obesity, smoking, depression, a hemoglobin A1c of 7% or more, and being on opioids. These risk factors are incompatible with outpatient hip or knee replacement.
“Let the surgeon know if you think outpatient joint replacement is a bad idea in your patient for medical reasons,” Dr. Bugbee urged.
Also, orthopedic surgeons can generally benefit from rheumatologist input regarding perioperative management of patients on standard disease-modifying antirheumatic drugs, biologics, or Janus kinase inhibitors as recommended in the guidelines published jointly by the American College of Rheumatology and the American Association of Hip and Knee Surgeons.
“I can guarantee you that most orthopedic surgeons don’t know about these guidelines. The evidence base for these recommendations is not great, but these are the best guidelines we have,” Dr. Bugbee said.
After joint replacement surgery a patient should get an x-ray of the replacement every 5 years. And if a patient develops a painful hip after arthroplasty, it’s worthwhile to order blood chromium and cobalt levels.
“The implant weight-bearing surface matters. You can’t necessarily tell on x-ray what’s a metal-on-metal hip and what’s metal-on-plastic or ceramic. You already send people for a lot of labs. If you see a patient with a painful total hip replacement, just add a cobalt and chromium. If they’re elevated, talk to the orthopedist,” he advised.
The road ahead
Hip and knee replacement is an $18 billion market today. And it’s a major growth industry: According to a recent projection, there will be 1 million total hip replacements and 4 million total knee replacements annually 10 years from now, figures four times greater than projected for 2030 in an earlier 2005 estimate. The rapid growth is coming from the expanding elderly population combined with a virtual epidemic of posttraumatic arthritis in young people – but decidedly not from patients with joint failure attributable to rheumatoid arthritis.
“Congratulations! You’ve eradicated rheumatoid arthritis from my practice,” Dr. Bugbee declared. “Most of the rheumatoid arthritis patients who come to me come because they have osteoarthritis in their joint, not because of their rheumatoid arthritis.”
He reported serving as a consultant to Orthalign, Insight Medical, and Arthrex, and receiving royalties from Smith and Nephew and Depuy.
MAUI, HAWAII – Outpatient total hip and knee replacement is “the latest craze” in orthopedic surgery, and it’s being driven by the might of Medicare, William Bugbee, MD, said at the 2020 Rheumatology Winter Clinical Symposium.
“In 2019, Medicare took total knee replacement off the inpatient-only list, meaning you could do it as an outpatient. And just in January 2020, they took total hips off that list. So I have to designate most of my hip and knee replacements as outpatients, even if I do it in the hospital and keep them for 1 night. And some of the private insurers have already gone to that, so they’ll deny coverage if I say I want a 1-day hospital stay, believe it or not,” according to Dr. Bugbee, chief of joint reconstruction in the department of orthopedics at the Scripps Clinic in La Jolla, Calif.
He provided a behind-the-scenes look at contemporary trends in joint replacement as well as tips on how rheumatologists can best help their patients get through the experience with excellent outcomes.
Joint replacement remains the best treatment for advanced arthritis of the hips and knees, he said. There is a high degree of confidence about the predictability and durability of the results. But joint replacement has become highly commoditized.
“We’re getting pummeled by Medicare to make this as cheap as possible,” the orthopedic surgeon explained. “An implant costs the hospital $3,000-$6,000. A care episode for a primary total joint replacement should cost a hospital $8,000-$15,000, which is about what Medicare pays for the [Diagnosis Related Group], so the margins are small. That’s why we’re being drilled on about how much we spend on every little thing. We hardly do any labs, x-rays, anything.”
As a result of recent advances in pre-, peri-, and postoperative management, outpatient joint replacement has become a safe and comparatively economical option for generally healthy patients.
“We’ve engineered a much better patient experience, so the assault and battery of 5, 10, 15 years ago isn’t so bad anymore,” Dr. Bugbee said.
Rheumatologists can expect to see a growing number of their patients undergoing total knee or hip replacement at outpatient surgery centers. That’s not a bad thing so long as the procedure is being done there because the outpatient center employs best practices in order to provide a highly efficient episode of care supported by excellent outcome data, he continued.
State-of-the-art perioperative management in 2020 includes accelerated-care pathways that allow ambulation within an hour or 2 after surgery along with same-day discharge, regional anesthesia with motor-sparing nerve blocks, and multimodal pain management with avoidance of intravenous narcotics except in opioid-tolerant patients. Tranexamic acid is now widely used in order to reduce operative blood loss.
“When I started practice 25 years ago, 50% of patients got a blood transfusion. I haven’t given a blood transfusion to a patient in probably 2 years. Tranexamic acid reduces blood loss by 500-700 cc with no discernible adverse effects. It’s truly remarkable,” he said.
Another important technical advance has been the routine use of oral dexamethasone. “Decadron is an antiemetic, it has anti-inflammatory effects, and it makes people happy. It’s a simple, cheap drug that has revolutionized care,” the surgeon continued.
Postoperative management has been streamlined. Dr. Bugbee is among many orthopedic surgeons who no longer routinely prescribe therapist-directed formal physical therapy for total hip arthroplasty patients, relying instead upon online tools and apps for self-administered physical therapy. Pedal exercise devices available online for $30 or so have been shown to be as effective as supervised physical therapy for knee rehabilitation.
What patients want to know about joint replacement
The question patients most often ask both their referring physician and the orthopedic surgeon is, “How long will my joint replacement last?” The best available data come from a couple of recent paired meta-analyses. The investigators reported 82% implant survivorship 25 years after primary total knee arthroplasty and 70% after unicondylar knee arthroplasty as well as a 25-year implant survivorship rate of 77% for total hip arthroplasty.
“I expected that hip arthroplasty survivorship rate to be much higher than 77%. The reason it’s not is probably because of the metal-on-metal bearing surface debacle of about 10 years ago. There’ve been lots of revisions because of that. We thought metal-on-metal implants were going to be all that, with microscopically low wear, but they turned out to be a nightmare because of metal ion release,” Dr. Bugbee observed.
The long-term joint survivorship data are based upon older implants. Encouraging albeit still preliminary data suggest contemporary implants may last significantly longer. The “clear winner,” he said, is a 36-mm ceramic head and a highly crosslinked polyethylene liner.
“That’s been a game changer, with a 10- to 20-fold decrease in wear compared to plastics for weight-bearing surfaces,” Dr. Bugbee said.
In terms of functional improvement, by various measures 85%-97% of patients are satisfied with the results of their total hip replacement, and 60% report returning to high-level recreational activities. Patient satisfaction scores are lower – 75%-90% – after total knee arthroplasty.
“The total knee replacement just doesn’t work like a regular joint,” the surgeon observed. “When I think of hip and knee replacements, I think of a hip as a Ferrari – it’s a high-performance joint replacement – and I think of the knee as a Ford – it’s serviceable, it does the job, and it’s okay but not fantastic.”
How referring physicians can optimize preoperative management and long-term follow-up
Orthopedic surgeons would appreciate help from rheumatologists and primary care physicians in preoperatively addressing the known modifiable risk factors for poor outcomes of joint replacement. These include obesity, smoking, depression, a hemoglobin A1c of 7% or more, and being on opioids. These risk factors are incompatible with outpatient hip or knee replacement.
“Let the surgeon know if you think outpatient joint replacement is a bad idea in your patient for medical reasons,” Dr. Bugbee urged.
Also, orthopedic surgeons can generally benefit from rheumatologist input regarding perioperative management of patients on standard disease-modifying antirheumatic drugs, biologics, or Janus kinase inhibitors as recommended in the guidelines published jointly by the American College of Rheumatology and the American Association of Hip and Knee Surgeons.
“I can guarantee you that most orthopedic surgeons don’t know about these guidelines. The evidence base for these recommendations is not great, but these are the best guidelines we have,” Dr. Bugbee said.
After joint replacement surgery a patient should get an x-ray of the replacement every 5 years. And if a patient develops a painful hip after arthroplasty, it’s worthwhile to order blood chromium and cobalt levels.
“The implant weight-bearing surface matters. You can’t necessarily tell on x-ray what’s a metal-on-metal hip and what’s metal-on-plastic or ceramic. You already send people for a lot of labs. If you see a patient with a painful total hip replacement, just add a cobalt and chromium. If they’re elevated, talk to the orthopedist,” he advised.
The road ahead
Hip and knee replacement is an $18 billion market today. And it’s a major growth industry: According to a recent projection, there will be 1 million total hip replacements and 4 million total knee replacements annually 10 years from now, figures four times greater than projected for 2030 in an earlier 2005 estimate. The rapid growth is coming from the expanding elderly population combined with a virtual epidemic of posttraumatic arthritis in young people – but decidedly not from patients with joint failure attributable to rheumatoid arthritis.
“Congratulations! You’ve eradicated rheumatoid arthritis from my practice,” Dr. Bugbee declared. “Most of the rheumatoid arthritis patients who come to me come because they have osteoarthritis in their joint, not because of their rheumatoid arthritis.”
He reported serving as a consultant to Orthalign, Insight Medical, and Arthrex, and receiving royalties from Smith and Nephew and Depuy.
MAUI, HAWAII – Outpatient total hip and knee replacement is “the latest craze” in orthopedic surgery, and it’s being driven by the might of Medicare, William Bugbee, MD, said at the 2020 Rheumatology Winter Clinical Symposium.
“In 2019, Medicare took total knee replacement off the inpatient-only list, meaning you could do it as an outpatient. And just in January 2020, they took total hips off that list. So I have to designate most of my hip and knee replacements as outpatients, even if I do it in the hospital and keep them for 1 night. And some of the private insurers have already gone to that, so they’ll deny coverage if I say I want a 1-day hospital stay, believe it or not,” according to Dr. Bugbee, chief of joint reconstruction in the department of orthopedics at the Scripps Clinic in La Jolla, Calif.
He provided a behind-the-scenes look at contemporary trends in joint replacement as well as tips on how rheumatologists can best help their patients get through the experience with excellent outcomes.
Joint replacement remains the best treatment for advanced arthritis of the hips and knees, he said. There is a high degree of confidence about the predictability and durability of the results. But joint replacement has become highly commoditized.
“We’re getting pummeled by Medicare to make this as cheap as possible,” the orthopedic surgeon explained. “An implant costs the hospital $3,000-$6,000. A care episode for a primary total joint replacement should cost a hospital $8,000-$15,000, which is about what Medicare pays for the [Diagnosis Related Group], so the margins are small. That’s why we’re being drilled on about how much we spend on every little thing. We hardly do any labs, x-rays, anything.”
As a result of recent advances in pre-, peri-, and postoperative management, outpatient joint replacement has become a safe and comparatively economical option for generally healthy patients.
“We’ve engineered a much better patient experience, so the assault and battery of 5, 10, 15 years ago isn’t so bad anymore,” Dr. Bugbee said.
Rheumatologists can expect to see a growing number of their patients undergoing total knee or hip replacement at outpatient surgery centers. That’s not a bad thing so long as the procedure is being done there because the outpatient center employs best practices in order to provide a highly efficient episode of care supported by excellent outcome data, he continued.
State-of-the-art perioperative management in 2020 includes accelerated-care pathways that allow ambulation within an hour or 2 after surgery along with same-day discharge, regional anesthesia with motor-sparing nerve blocks, and multimodal pain management with avoidance of intravenous narcotics except in opioid-tolerant patients. Tranexamic acid is now widely used in order to reduce operative blood loss.
“When I started practice 25 years ago, 50% of patients got a blood transfusion. I haven’t given a blood transfusion to a patient in probably 2 years. Tranexamic acid reduces blood loss by 500-700 cc with no discernible adverse effects. It’s truly remarkable,” he said.
Another important technical advance has been the routine use of oral dexamethasone. “Decadron is an antiemetic, it has anti-inflammatory effects, and it makes people happy. It’s a simple, cheap drug that has revolutionized care,” the surgeon continued.
Postoperative management has been streamlined. Dr. Bugbee is among many orthopedic surgeons who no longer routinely prescribe therapist-directed formal physical therapy for total hip arthroplasty patients, relying instead upon online tools and apps for self-administered physical therapy. Pedal exercise devices available online for $30 or so have been shown to be as effective as supervised physical therapy for knee rehabilitation.
What patients want to know about joint replacement
The question patients most often ask both their referring physician and the orthopedic surgeon is, “How long will my joint replacement last?” The best available data come from a couple of recent paired meta-analyses. The investigators reported 82% implant survivorship 25 years after primary total knee arthroplasty and 70% after unicondylar knee arthroplasty as well as a 25-year implant survivorship rate of 77% for total hip arthroplasty.
“I expected that hip arthroplasty survivorship rate to be much higher than 77%. The reason it’s not is probably because of the metal-on-metal bearing surface debacle of about 10 years ago. There’ve been lots of revisions because of that. We thought metal-on-metal implants were going to be all that, with microscopically low wear, but they turned out to be a nightmare because of metal ion release,” Dr. Bugbee observed.
The long-term joint survivorship data are based upon older implants. Encouraging albeit still preliminary data suggest contemporary implants may last significantly longer. The “clear winner,” he said, is a 36-mm ceramic head and a highly crosslinked polyethylene liner.
“That’s been a game changer, with a 10- to 20-fold decrease in wear compared to plastics for weight-bearing surfaces,” Dr. Bugbee said.
In terms of functional improvement, by various measures 85%-97% of patients are satisfied with the results of their total hip replacement, and 60% report returning to high-level recreational activities. Patient satisfaction scores are lower – 75%-90% – after total knee arthroplasty.
“The total knee replacement just doesn’t work like a regular joint,” the surgeon observed. “When I think of hip and knee replacements, I think of a hip as a Ferrari – it’s a high-performance joint replacement – and I think of the knee as a Ford – it’s serviceable, it does the job, and it’s okay but not fantastic.”
How referring physicians can optimize preoperative management and long-term follow-up
Orthopedic surgeons would appreciate help from rheumatologists and primary care physicians in preoperatively addressing the known modifiable risk factors for poor outcomes of joint replacement. These include obesity, smoking, depression, a hemoglobin A1c of 7% or more, and being on opioids. These risk factors are incompatible with outpatient hip or knee replacement.
“Let the surgeon know if you think outpatient joint replacement is a bad idea in your patient for medical reasons,” Dr. Bugbee urged.
Also, orthopedic surgeons can generally benefit from rheumatologist input regarding perioperative management of patients on standard disease-modifying antirheumatic drugs, biologics, or Janus kinase inhibitors as recommended in the guidelines published jointly by the American College of Rheumatology and the American Association of Hip and Knee Surgeons.
“I can guarantee you that most orthopedic surgeons don’t know about these guidelines. The evidence base for these recommendations is not great, but these are the best guidelines we have,” Dr. Bugbee said.
After joint replacement surgery a patient should get an x-ray of the replacement every 5 years. And if a patient develops a painful hip after arthroplasty, it’s worthwhile to order blood chromium and cobalt levels.
“The implant weight-bearing surface matters. You can’t necessarily tell on x-ray what’s a metal-on-metal hip and what’s metal-on-plastic or ceramic. You already send people for a lot of labs. If you see a patient with a painful total hip replacement, just add a cobalt and chromium. If they’re elevated, talk to the orthopedist,” he advised.
The road ahead
Hip and knee replacement is an $18 billion market today. And it’s a major growth industry: According to a recent projection, there will be 1 million total hip replacements and 4 million total knee replacements annually 10 years from now, figures four times greater than projected for 2030 in an earlier 2005 estimate. The rapid growth is coming from the expanding elderly population combined with a virtual epidemic of posttraumatic arthritis in young people – but decidedly not from patients with joint failure attributable to rheumatoid arthritis.
“Congratulations! You’ve eradicated rheumatoid arthritis from my practice,” Dr. Bugbee declared. “Most of the rheumatoid arthritis patients who come to me come because they have osteoarthritis in their joint, not because of their rheumatoid arthritis.”
He reported serving as a consultant to Orthalign, Insight Medical, and Arthrex, and receiving royalties from Smith and Nephew and Depuy.
REPORTING FROM RWCS 2020
Pondering jumping into teledermatology?
LAHAINA, HAWAII – Teledermatology and dermoscopy were made for each other, Trilokraj Tejasvi, MBBS, MD, declared at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.
“If somebody is The dermatoscope manufacturers make teledermoscopy systems with attachments for iPhones, iPads, and Android devices,” said Dr. Tejasvi, who is director of teledermatology services and also director of the cutaneous lymphoma program at the University of Michigan, Ann Arbor.
To make his point, he presented slides of six standard unenhanced teledermatologic photos of ambiguous pigmented skin lesions. When he asked the large audience which ones they’d want to biopsy and which they were confident were benign, there was absolutely no consensus. But when he followed up with teledermoscopic photos of the same lesions, the dermoscopists in the audience quickly voiced agreement that four of the lesions were benign and two were obvious melanoma. Based on that information, instead of having to bring in all six patients for biopsy of their indeterminant suspicious lesions, only two of the patients would need to come in promptly for treatment of their malignancy.
“Dermoscopy changes the whole triage system and the teledermoscopy concept model, because dermoscopy remains the same: it’s going to stay [two-dimensional] whether you’re going to see the images in the clinic or in teledermatology. So using teledermoscopy images actually makes it far better for your teledermatology services,” explained Dr. Tejasvi, who is also chief of the dermatology service at the Ann Arbor Veterans Affairs Hospital.
Why get into teledermatology?
The benefits of teledermatology include earlier diagnosis and treatment of skin cancers as documented in a Spanish study of 43,677 patients. The Spanish dermatologists reported that teledermatologically detected melanomas had a thinner Breslow depth and lower tumor stage because they were diagnosed earlier. Teledermatology also brought a twofold increase in the basal cell carcinoma detection rate and – most importantly – a reduction in time to biopsy for what turned out to be skin cancers (JAMA Dermatol. 2015 Dec 1;151[12]:1289-90).
In addition, teledermatology is an effective triage tool for busy clinicians whose appointment calendars are booked weeks or months in advance.
“Let’s say you are the only dermatologist in the surrounding five counties. You can use teledermatology to see which patients actually need to come to your clinic,” Dr. Tejasvri said. Just make sure the referring primary care providers know to send photos taken with the dermatoscope attachment.
Internet-based teledermatology also provides a way to follow patients with chronic conditions, including psoriasis, atopic dermatitis, and venous ulcers, he noted.
Before getting started
Dr. Tejasvri emphasized the importance of visiting the American Academy of Dermatology Teledermatology Task Force website as well as the American Telemedicine Association’s Teledermatology Special Interest Group, which he chairs. These resources, he stressed, are invaluable.
The AAD site, open to all academy members, includes a tool kit for getting started in teledermatology. It’s individually tailored for the dermatologist in solo, small group, academic, or multispecialty practice. This highly practical tool kit includes a checklist that aids in determining whether a dermatologist’s practice is suited for teledermatology, as well as the suggested optimal teledermatology practice model for that individual, the nuts and bolts of equipment, relevant state laws, and how to navigate legal concerns, among the most critical of which is to get in writing the malpractice insurer’s verbal reassurance that the policy covers telemedicine.
The American Telemedicine Association Teledermatology Special Interest Group provides best-practice guidelines (Telemed J E Health. 2016 Dec;22[12]:981-90)
Teledermatology practice model options
The most common teledermatology model is called “store-and-forward.” It relies upon transmission of still images of skin lesions. Its advantages are that it’s not dependent upon internet speed and it accommodates physicians working in different time zones. Most commonly, this is a consult model in which a remote primary care provider takes the photos and transmits them to the dermatologist specialist. The referring provider retains responsibility for patient care.
The other model entails creation of a virtual clinic with real-time videoconference-based communication using a HIPAA-compliant high-speed broadband internet connection. The advantages are that reimbursement is good – indeed, the same as for a face-to-face office visit – and it’s possible to ask questions of the patient and referring physician, although that’s generally not necessary for the straightforward evaluation of suspicious pigmented or nonpigmented skin lesions. However, the video image quality isn’t as good as with still photos, the virtual clinic requires dedicated scheduling, and the quality of the experience is highly dependent upon internet speed.
“If you have a bad internet speed the whole process becomes choppy. When you ask a question, the answer you get is the one to your previous question,” Dr. Tejasvi said.
Reimbursement
Currently 38 states and Washington, D.C., have laws governing private payer telehealth reimbursement policy.
Under the 2019 Medicare physician fee schedule, code number 99446 – interprofessional telephone/internet consult lasting 5-10 minutes – pays $18.36. A 99447, lasting 11-20 minutes, pays $36.36, and a 99448, representing a 21-30 minute interprofessional consult, pays $54.72.
“Reimbursement is poor. It’s not a lot at all. If you spend 5-10 minutes on a consult you get paid about 20 bucks. But it’s better than nothing, and it used to be that patients had to pay out of pocket,” the dermatologist commented.
And of course, the improved timely and efficient patient access to dermatologist evaluation of potential skin cancer that’s afforded via teledermatology helps out with the profession’s workforce shortage and responds to the common criticism that dermatologists are geographically maldistributed and treatment delayed is treatment denied.
How accurate is teledermatology?
Numerous studies have reported diagnostic concordance rates between teledermatology and face-to-face clinical diagnosis of 72.5%-90% for melanoma, dropping off markedly to 31.2%-62% for lentigines. However, teledermoscopic images greatly improved the diagnostic accuracy.
In one recent study involving teledermatology versus face-to-face evaluation of 293 index lesions, the face-to-face dermatologist examination turned up 131 incidental skin lesions, including 6 incidental melanomas not suspected or photographed by the consulting primary care providers. That worked out to a 2.6% risk of incidental melanoma per consult, which Dr. Tejasvi called “kind of scary.”
“All six of the incidental melanomas were located on the back, chest, or abdomen, so a good teaching point is that, if you’re doing a teledermatology consult, ask the primary care provider who’s sending you this consult to do a careful waist-up exam to look for other lesions,” he advised.
He added that more and larger studies are needed in order to determine the diagnostic concordance rate for nonpigmented lesions.
Dr. Tejasvi reported having no financial conflicts regarding his presentation.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
LAHAINA, HAWAII – Teledermatology and dermoscopy were made for each other, Trilokraj Tejasvi, MBBS, MD, declared at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.
“If somebody is The dermatoscope manufacturers make teledermoscopy systems with attachments for iPhones, iPads, and Android devices,” said Dr. Tejasvi, who is director of teledermatology services and also director of the cutaneous lymphoma program at the University of Michigan, Ann Arbor.
To make his point, he presented slides of six standard unenhanced teledermatologic photos of ambiguous pigmented skin lesions. When he asked the large audience which ones they’d want to biopsy and which they were confident were benign, there was absolutely no consensus. But when he followed up with teledermoscopic photos of the same lesions, the dermoscopists in the audience quickly voiced agreement that four of the lesions were benign and two were obvious melanoma. Based on that information, instead of having to bring in all six patients for biopsy of their indeterminant suspicious lesions, only two of the patients would need to come in promptly for treatment of their malignancy.
“Dermoscopy changes the whole triage system and the teledermoscopy concept model, because dermoscopy remains the same: it’s going to stay [two-dimensional] whether you’re going to see the images in the clinic or in teledermatology. So using teledermoscopy images actually makes it far better for your teledermatology services,” explained Dr. Tejasvi, who is also chief of the dermatology service at the Ann Arbor Veterans Affairs Hospital.
Why get into teledermatology?
The benefits of teledermatology include earlier diagnosis and treatment of skin cancers as documented in a Spanish study of 43,677 patients. The Spanish dermatologists reported that teledermatologically detected melanomas had a thinner Breslow depth and lower tumor stage because they were diagnosed earlier. Teledermatology also brought a twofold increase in the basal cell carcinoma detection rate and – most importantly – a reduction in time to biopsy for what turned out to be skin cancers (JAMA Dermatol. 2015 Dec 1;151[12]:1289-90).
In addition, teledermatology is an effective triage tool for busy clinicians whose appointment calendars are booked weeks or months in advance.
“Let’s say you are the only dermatologist in the surrounding five counties. You can use teledermatology to see which patients actually need to come to your clinic,” Dr. Tejasvri said. Just make sure the referring primary care providers know to send photos taken with the dermatoscope attachment.
Internet-based teledermatology also provides a way to follow patients with chronic conditions, including psoriasis, atopic dermatitis, and venous ulcers, he noted.
Before getting started
Dr. Tejasvri emphasized the importance of visiting the American Academy of Dermatology Teledermatology Task Force website as well as the American Telemedicine Association’s Teledermatology Special Interest Group, which he chairs. These resources, he stressed, are invaluable.
The AAD site, open to all academy members, includes a tool kit for getting started in teledermatology. It’s individually tailored for the dermatologist in solo, small group, academic, or multispecialty practice. This highly practical tool kit includes a checklist that aids in determining whether a dermatologist’s practice is suited for teledermatology, as well as the suggested optimal teledermatology practice model for that individual, the nuts and bolts of equipment, relevant state laws, and how to navigate legal concerns, among the most critical of which is to get in writing the malpractice insurer’s verbal reassurance that the policy covers telemedicine.
The American Telemedicine Association Teledermatology Special Interest Group provides best-practice guidelines (Telemed J E Health. 2016 Dec;22[12]:981-90)
Teledermatology practice model options
The most common teledermatology model is called “store-and-forward.” It relies upon transmission of still images of skin lesions. Its advantages are that it’s not dependent upon internet speed and it accommodates physicians working in different time zones. Most commonly, this is a consult model in which a remote primary care provider takes the photos and transmits them to the dermatologist specialist. The referring provider retains responsibility for patient care.
The other model entails creation of a virtual clinic with real-time videoconference-based communication using a HIPAA-compliant high-speed broadband internet connection. The advantages are that reimbursement is good – indeed, the same as for a face-to-face office visit – and it’s possible to ask questions of the patient and referring physician, although that’s generally not necessary for the straightforward evaluation of suspicious pigmented or nonpigmented skin lesions. However, the video image quality isn’t as good as with still photos, the virtual clinic requires dedicated scheduling, and the quality of the experience is highly dependent upon internet speed.
“If you have a bad internet speed the whole process becomes choppy. When you ask a question, the answer you get is the one to your previous question,” Dr. Tejasvi said.
Reimbursement
Currently 38 states and Washington, D.C., have laws governing private payer telehealth reimbursement policy.
Under the 2019 Medicare physician fee schedule, code number 99446 – interprofessional telephone/internet consult lasting 5-10 minutes – pays $18.36. A 99447, lasting 11-20 minutes, pays $36.36, and a 99448, representing a 21-30 minute interprofessional consult, pays $54.72.
“Reimbursement is poor. It’s not a lot at all. If you spend 5-10 minutes on a consult you get paid about 20 bucks. But it’s better than nothing, and it used to be that patients had to pay out of pocket,” the dermatologist commented.
And of course, the improved timely and efficient patient access to dermatologist evaluation of potential skin cancer that’s afforded via teledermatology helps out with the profession’s workforce shortage and responds to the common criticism that dermatologists are geographically maldistributed and treatment delayed is treatment denied.
How accurate is teledermatology?
Numerous studies have reported diagnostic concordance rates between teledermatology and face-to-face clinical diagnosis of 72.5%-90% for melanoma, dropping off markedly to 31.2%-62% for lentigines. However, teledermoscopic images greatly improved the diagnostic accuracy.
In one recent study involving teledermatology versus face-to-face evaluation of 293 index lesions, the face-to-face dermatologist examination turned up 131 incidental skin lesions, including 6 incidental melanomas not suspected or photographed by the consulting primary care providers. That worked out to a 2.6% risk of incidental melanoma per consult, which Dr. Tejasvi called “kind of scary.”
“All six of the incidental melanomas were located on the back, chest, or abdomen, so a good teaching point is that, if you’re doing a teledermatology consult, ask the primary care provider who’s sending you this consult to do a careful waist-up exam to look for other lesions,” he advised.
He added that more and larger studies are needed in order to determine the diagnostic concordance rate for nonpigmented lesions.
Dr. Tejasvi reported having no financial conflicts regarding his presentation.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
LAHAINA, HAWAII – Teledermatology and dermoscopy were made for each other, Trilokraj Tejasvi, MBBS, MD, declared at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.
“If somebody is The dermatoscope manufacturers make teledermoscopy systems with attachments for iPhones, iPads, and Android devices,” said Dr. Tejasvi, who is director of teledermatology services and also director of the cutaneous lymphoma program at the University of Michigan, Ann Arbor.
To make his point, he presented slides of six standard unenhanced teledermatologic photos of ambiguous pigmented skin lesions. When he asked the large audience which ones they’d want to biopsy and which they were confident were benign, there was absolutely no consensus. But when he followed up with teledermoscopic photos of the same lesions, the dermoscopists in the audience quickly voiced agreement that four of the lesions were benign and two were obvious melanoma. Based on that information, instead of having to bring in all six patients for biopsy of their indeterminant suspicious lesions, only two of the patients would need to come in promptly for treatment of their malignancy.
“Dermoscopy changes the whole triage system and the teledermoscopy concept model, because dermoscopy remains the same: it’s going to stay [two-dimensional] whether you’re going to see the images in the clinic or in teledermatology. So using teledermoscopy images actually makes it far better for your teledermatology services,” explained Dr. Tejasvi, who is also chief of the dermatology service at the Ann Arbor Veterans Affairs Hospital.
Why get into teledermatology?
The benefits of teledermatology include earlier diagnosis and treatment of skin cancers as documented in a Spanish study of 43,677 patients. The Spanish dermatologists reported that teledermatologically detected melanomas had a thinner Breslow depth and lower tumor stage because they were diagnosed earlier. Teledermatology also brought a twofold increase in the basal cell carcinoma detection rate and – most importantly – a reduction in time to biopsy for what turned out to be skin cancers (JAMA Dermatol. 2015 Dec 1;151[12]:1289-90).
In addition, teledermatology is an effective triage tool for busy clinicians whose appointment calendars are booked weeks or months in advance.
“Let’s say you are the only dermatologist in the surrounding five counties. You can use teledermatology to see which patients actually need to come to your clinic,” Dr. Tejasvri said. Just make sure the referring primary care providers know to send photos taken with the dermatoscope attachment.
Internet-based teledermatology also provides a way to follow patients with chronic conditions, including psoriasis, atopic dermatitis, and venous ulcers, he noted.
Before getting started
Dr. Tejasvri emphasized the importance of visiting the American Academy of Dermatology Teledermatology Task Force website as well as the American Telemedicine Association’s Teledermatology Special Interest Group, which he chairs. These resources, he stressed, are invaluable.
The AAD site, open to all academy members, includes a tool kit for getting started in teledermatology. It’s individually tailored for the dermatologist in solo, small group, academic, or multispecialty practice. This highly practical tool kit includes a checklist that aids in determining whether a dermatologist’s practice is suited for teledermatology, as well as the suggested optimal teledermatology practice model for that individual, the nuts and bolts of equipment, relevant state laws, and how to navigate legal concerns, among the most critical of which is to get in writing the malpractice insurer’s verbal reassurance that the policy covers telemedicine.
The American Telemedicine Association Teledermatology Special Interest Group provides best-practice guidelines (Telemed J E Health. 2016 Dec;22[12]:981-90)
Teledermatology practice model options
The most common teledermatology model is called “store-and-forward.” It relies upon transmission of still images of skin lesions. Its advantages are that it’s not dependent upon internet speed and it accommodates physicians working in different time zones. Most commonly, this is a consult model in which a remote primary care provider takes the photos and transmits them to the dermatologist specialist. The referring provider retains responsibility for patient care.
The other model entails creation of a virtual clinic with real-time videoconference-based communication using a HIPAA-compliant high-speed broadband internet connection. The advantages are that reimbursement is good – indeed, the same as for a face-to-face office visit – and it’s possible to ask questions of the patient and referring physician, although that’s generally not necessary for the straightforward evaluation of suspicious pigmented or nonpigmented skin lesions. However, the video image quality isn’t as good as with still photos, the virtual clinic requires dedicated scheduling, and the quality of the experience is highly dependent upon internet speed.
“If you have a bad internet speed the whole process becomes choppy. When you ask a question, the answer you get is the one to your previous question,” Dr. Tejasvi said.
Reimbursement
Currently 38 states and Washington, D.C., have laws governing private payer telehealth reimbursement policy.
Under the 2019 Medicare physician fee schedule, code number 99446 – interprofessional telephone/internet consult lasting 5-10 minutes – pays $18.36. A 99447, lasting 11-20 minutes, pays $36.36, and a 99448, representing a 21-30 minute interprofessional consult, pays $54.72.
“Reimbursement is poor. It’s not a lot at all. If you spend 5-10 minutes on a consult you get paid about 20 bucks. But it’s better than nothing, and it used to be that patients had to pay out of pocket,” the dermatologist commented.
And of course, the improved timely and efficient patient access to dermatologist evaluation of potential skin cancer that’s afforded via teledermatology helps out with the profession’s workforce shortage and responds to the common criticism that dermatologists are geographically maldistributed and treatment delayed is treatment denied.
How accurate is teledermatology?
Numerous studies have reported diagnostic concordance rates between teledermatology and face-to-face clinical diagnosis of 72.5%-90% for melanoma, dropping off markedly to 31.2%-62% for lentigines. However, teledermoscopic images greatly improved the diagnostic accuracy.
In one recent study involving teledermatology versus face-to-face evaluation of 293 index lesions, the face-to-face dermatologist examination turned up 131 incidental skin lesions, including 6 incidental melanomas not suspected or photographed by the consulting primary care providers. That worked out to a 2.6% risk of incidental melanoma per consult, which Dr. Tejasvi called “kind of scary.”
“All six of the incidental melanomas were located on the back, chest, or abdomen, so a good teaching point is that, if you’re doing a teledermatology consult, ask the primary care provider who’s sending you this consult to do a careful waist-up exam to look for other lesions,” he advised.
He added that more and larger studies are needed in order to determine the diagnostic concordance rate for nonpigmented lesions.
Dr. Tejasvi reported having no financial conflicts regarding his presentation.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
EXPERT ANALYSIS FROM SDEF HAWAII DERMATOLOGY SEMINAR
Reassurance on general anesthesia in young kids
LAHAINA, HAWAII – Two recent large, well-conducted, and persuasive Jessica Sprague, MD, said at the SDEF Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.
“These two studies can be cited in conversation with parents and are very reassuring for a single episode of general anesthesia,” observed Dr. Sprague, a dermatologist at Rady Children’s Hospital and the University of California, both in San Diego.
“As a take home, I think we can feel pretty confident that single exposure to short-duration general anesthesia does not have any adverse neurocognitive effects,” she added.
In 2016, the Food and Drug Administration issued a drug safety communication that general anesthesia lasting for more than 3 hours in children aged less than 3 years, or repeated shorter-duration general anesthesia, may affect the development of children’s brains. This edict caused considerable turmoil among both physicians and parents. The warning was based upon animal studies suggesting adverse effects, including abnormal axon formation and other structural changes, impaired learning and memory, and heightened emotional reactivity to threats. Preliminary human cohort studies generated conflicting results, but were tough to interpret because of potential confounding issues, most prominently the distinct possibility that the very reason the child was undergoing general anesthesia might inherently predispose to neurodevelopmental problems, the dermatologist explained.
Enter the GAS trial, a multinational, assessor-blinded study in which 722 generally healthy infants undergoing hernia repair at 28 centers in the United States and six other countries were randomized to general anesthesia for a median of 54 minutes or awake regional anesthesia. Assessment via a detailed neuropsychological test battery and parent questionnaires at age 2 and 5 years showed no between-group differences at all. Of note, the GAS trial was funded by the FDA, the National Institutes of Health, and similar national health care agencies in the other participating countries (Lancet. 2019 Feb 16;393[10172]:664-77).
The other major recent research contribution was a province-wide Ontario study led by investigators at the Hospital for Sick Children in Toronto. This retrospective study included 2,346 sibling pairs aged 4-5 years in which one child in each pair received general anesthesia as a preschooler. All participants underwent testing using the comprehensive Early Development Instrument. Reassuringly, no between-group differences were found in any of the five domains assessed by the testing: language and cognitive development, physical health and well-being, emotional health and maturity, social knowledge and competence, and communication skills and general knowledge (JAMA Pediatr. 2019 Jan 1;173[1]:29-36).
These two studies address a pressing issue, since 10% of children in the United States and other developed countries receive general anesthesia within their first 3 years of life. Common indications in dermatology include excisional surgery, laser therapy for extensive port wine birthmarks, and diagnostic MRIs.
Dr. Sprague advised that, based upon the new data, “you definitely do not want to delay necessary imaging studies or surgeries, but MRIs can often be done without general anesthesia in infants less than 2 months old. If you have an infant who needs an MRI for something like PHACE syndrome [posterior fossa brain malformations, hemangioma, arterial lesions, cardiac abnormalities, and eye abnormalities], if you can get them in before 2 months of age sometimes you can avoid the general anesthesia if you wrap them tight enough. But once they get over 2 months ,there’s too much wiggle and it’s pretty impossible.”
Her other suggestions:
- Consider delaying nonurgent surgeries and imaging until at least age 6 months and ideally 3 years. “Parents will eventually want surgery to be done for a benign-appearing congenital nevus on the cheek, but it doesn’t necessarily need to be done before 6 months. The same with a residual hemangioma. I would recommend doing it before they go to kindergarten and before they get a sort of sense of what their self looks like, but you have some time between ages 3 and 5 to do that,” Dr. Sprague said.
- Seek out an anesthesiologist who has extensive experience with infants and young children, as is common at a dedicated children’s hospital. “If you live somewhere where the anesthesiologists are primarily seeing adult patients, they’re just not as good,” according to the pediatric dermatologist.
- Definitely consider a topical anesthesia strategy in infants who require multiple procedures, because there remains some unresolved concern about the potential neurodevelopmental impact of multiple bouts of general anesthesia.
Dr. Sprague reported having no financial conflicts regarding her presentation.
The SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
LAHAINA, HAWAII – Two recent large, well-conducted, and persuasive Jessica Sprague, MD, said at the SDEF Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.
“These two studies can be cited in conversation with parents and are very reassuring for a single episode of general anesthesia,” observed Dr. Sprague, a dermatologist at Rady Children’s Hospital and the University of California, both in San Diego.
“As a take home, I think we can feel pretty confident that single exposure to short-duration general anesthesia does not have any adverse neurocognitive effects,” she added.
In 2016, the Food and Drug Administration issued a drug safety communication that general anesthesia lasting for more than 3 hours in children aged less than 3 years, or repeated shorter-duration general anesthesia, may affect the development of children’s brains. This edict caused considerable turmoil among both physicians and parents. The warning was based upon animal studies suggesting adverse effects, including abnormal axon formation and other structural changes, impaired learning and memory, and heightened emotional reactivity to threats. Preliminary human cohort studies generated conflicting results, but were tough to interpret because of potential confounding issues, most prominently the distinct possibility that the very reason the child was undergoing general anesthesia might inherently predispose to neurodevelopmental problems, the dermatologist explained.
Enter the GAS trial, a multinational, assessor-blinded study in which 722 generally healthy infants undergoing hernia repair at 28 centers in the United States and six other countries were randomized to general anesthesia for a median of 54 minutes or awake regional anesthesia. Assessment via a detailed neuropsychological test battery and parent questionnaires at age 2 and 5 years showed no between-group differences at all. Of note, the GAS trial was funded by the FDA, the National Institutes of Health, and similar national health care agencies in the other participating countries (Lancet. 2019 Feb 16;393[10172]:664-77).
The other major recent research contribution was a province-wide Ontario study led by investigators at the Hospital for Sick Children in Toronto. This retrospective study included 2,346 sibling pairs aged 4-5 years in which one child in each pair received general anesthesia as a preschooler. All participants underwent testing using the comprehensive Early Development Instrument. Reassuringly, no between-group differences were found in any of the five domains assessed by the testing: language and cognitive development, physical health and well-being, emotional health and maturity, social knowledge and competence, and communication skills and general knowledge (JAMA Pediatr. 2019 Jan 1;173[1]:29-36).
These two studies address a pressing issue, since 10% of children in the United States and other developed countries receive general anesthesia within their first 3 years of life. Common indications in dermatology include excisional surgery, laser therapy for extensive port wine birthmarks, and diagnostic MRIs.
Dr. Sprague advised that, based upon the new data, “you definitely do not want to delay necessary imaging studies or surgeries, but MRIs can often be done without general anesthesia in infants less than 2 months old. If you have an infant who needs an MRI for something like PHACE syndrome [posterior fossa brain malformations, hemangioma, arterial lesions, cardiac abnormalities, and eye abnormalities], if you can get them in before 2 months of age sometimes you can avoid the general anesthesia if you wrap them tight enough. But once they get over 2 months ,there’s too much wiggle and it’s pretty impossible.”
Her other suggestions:
- Consider delaying nonurgent surgeries and imaging until at least age 6 months and ideally 3 years. “Parents will eventually want surgery to be done for a benign-appearing congenital nevus on the cheek, but it doesn’t necessarily need to be done before 6 months. The same with a residual hemangioma. I would recommend doing it before they go to kindergarten and before they get a sort of sense of what their self looks like, but you have some time between ages 3 and 5 to do that,” Dr. Sprague said.
- Seek out an anesthesiologist who has extensive experience with infants and young children, as is common at a dedicated children’s hospital. “If you live somewhere where the anesthesiologists are primarily seeing adult patients, they’re just not as good,” according to the pediatric dermatologist.
- Definitely consider a topical anesthesia strategy in infants who require multiple procedures, because there remains some unresolved concern about the potential neurodevelopmental impact of multiple bouts of general anesthesia.
Dr. Sprague reported having no financial conflicts regarding her presentation.
The SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
LAHAINA, HAWAII – Two recent large, well-conducted, and persuasive Jessica Sprague, MD, said at the SDEF Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.
“These two studies can be cited in conversation with parents and are very reassuring for a single episode of general anesthesia,” observed Dr. Sprague, a dermatologist at Rady Children’s Hospital and the University of California, both in San Diego.
“As a take home, I think we can feel pretty confident that single exposure to short-duration general anesthesia does not have any adverse neurocognitive effects,” she added.
In 2016, the Food and Drug Administration issued a drug safety communication that general anesthesia lasting for more than 3 hours in children aged less than 3 years, or repeated shorter-duration general anesthesia, may affect the development of children’s brains. This edict caused considerable turmoil among both physicians and parents. The warning was based upon animal studies suggesting adverse effects, including abnormal axon formation and other structural changes, impaired learning and memory, and heightened emotional reactivity to threats. Preliminary human cohort studies generated conflicting results, but were tough to interpret because of potential confounding issues, most prominently the distinct possibility that the very reason the child was undergoing general anesthesia might inherently predispose to neurodevelopmental problems, the dermatologist explained.
Enter the GAS trial, a multinational, assessor-blinded study in which 722 generally healthy infants undergoing hernia repair at 28 centers in the United States and six other countries were randomized to general anesthesia for a median of 54 minutes or awake regional anesthesia. Assessment via a detailed neuropsychological test battery and parent questionnaires at age 2 and 5 years showed no between-group differences at all. Of note, the GAS trial was funded by the FDA, the National Institutes of Health, and similar national health care agencies in the other participating countries (Lancet. 2019 Feb 16;393[10172]:664-77).
The other major recent research contribution was a province-wide Ontario study led by investigators at the Hospital for Sick Children in Toronto. This retrospective study included 2,346 sibling pairs aged 4-5 years in which one child in each pair received general anesthesia as a preschooler. All participants underwent testing using the comprehensive Early Development Instrument. Reassuringly, no between-group differences were found in any of the five domains assessed by the testing: language and cognitive development, physical health and well-being, emotional health and maturity, social knowledge and competence, and communication skills and general knowledge (JAMA Pediatr. 2019 Jan 1;173[1]:29-36).
These two studies address a pressing issue, since 10% of children in the United States and other developed countries receive general anesthesia within their first 3 years of life. Common indications in dermatology include excisional surgery, laser therapy for extensive port wine birthmarks, and diagnostic MRIs.
Dr. Sprague advised that, based upon the new data, “you definitely do not want to delay necessary imaging studies or surgeries, but MRIs can often be done without general anesthesia in infants less than 2 months old. If you have an infant who needs an MRI for something like PHACE syndrome [posterior fossa brain malformations, hemangioma, arterial lesions, cardiac abnormalities, and eye abnormalities], if you can get them in before 2 months of age sometimes you can avoid the general anesthesia if you wrap them tight enough. But once they get over 2 months ,there’s too much wiggle and it’s pretty impossible.”
Her other suggestions:
- Consider delaying nonurgent surgeries and imaging until at least age 6 months and ideally 3 years. “Parents will eventually want surgery to be done for a benign-appearing congenital nevus on the cheek, but it doesn’t necessarily need to be done before 6 months. The same with a residual hemangioma. I would recommend doing it before they go to kindergarten and before they get a sort of sense of what their self looks like, but you have some time between ages 3 and 5 to do that,” Dr. Sprague said.
- Seek out an anesthesiologist who has extensive experience with infants and young children, as is common at a dedicated children’s hospital. “If you live somewhere where the anesthesiologists are primarily seeing adult patients, they’re just not as good,” according to the pediatric dermatologist.
- Definitely consider a topical anesthesia strategy in infants who require multiple procedures, because there remains some unresolved concern about the potential neurodevelopmental impact of multiple bouts of general anesthesia.
Dr. Sprague reported having no financial conflicts regarding her presentation.
The SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
EXPERT ANALYSIS FROM SDEF HAWAII DERMATOLOGY SEMINAR
‘A glimmer of hope’ for stroke/mortality benefit with AFib catheter ablation
SNOWMASS, COLO. – stroke, major bleeding, or cardiac arrest, compared with rhythm and/or rate control drugs in a propensity score–weighted, retrospective, observational study.
Findings of the investigation, which included more than 183,000 real-world patients in routine clinical practice, were reported by Peter S. Noseworthy, MD, during the annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.
The results breathe new life into the controversy created by the previously reported CABANA trial (Catheter Ablation vs. Antiarrhythmic Drug Therapy for Atrial Fibrillation), a 10-country study in which 2,204 patients with atrial fibrillation (AFib) were randomized to catheter ablation or antiarrhythmic and/or rhythm control medications and followed for a mean of about 4 years. CABANA yielded a negative result (JAMA. 2019 Apr 2;321[13]:1261-74), with the prespecified intent-to-treat analysis indicating no significant between-group difference in the primary composite endpoint – the very same one that was positive in the large observational study.
However, CABANA was marred by major problems arising from protocol deviations: Nearly 28% of patients assigned to medical therapy crossed over to catheter ablation, typically because their antiarrhythmic drugs failed, and 10% of patients randomized to catheter ablation never got it. This muddies the waters when trying to identify a true stroke/mortality benefit for catheter ablation, if indeed any such benefit was actually present.
Here’s where the controversy arose: While CABANA must be called a negative trial based upon the disappointing results of the intent-to-treat analysis, a prespecified post hoc analysis of patients as actually treated showed a statistically significant 27% relative risk reduction for the primary composite endpoint in the catheter ablation group. That’s strikingly similar to the 30% relative risk reduction for catheter ablation seen in the huge observational study, where the CABANA-type primary outcome occurred in 22.5% of the medically managed patients and 16.8% of those who underwent catheter ablation, noted Dr. Noseworthy, professor of medicine and director of heart rhythm and physiology at the Mayo Clinic in Rochester, Minn.
He ought to know: He was both an investigator in CABANA and first author of the published observational study (Eur Heart J. 2019 Apr 21;40[16]:1257-64).
In the observational study, Dr. Noseworthy and coinvestigators utilized a huge U.S. administrative health claims database in order to identify a nationally representative group of 183,760 AFib patients, 12,032 of whom were treated with catheter ablation and the rest with antiarrhythmic and/or rhythm control drugs during the same years the CABANA trial was enrolling patients. The two groups were balanced using propensity score weighting to adjust for baseline differences in 90 variables.
The investigators sought to learn if the CABANA study population was representative of real-world AFib patients, and whether the observational experience could help resolve the CABANA controversy. It turned out that most AFib patients seen in daily clinical practice were CABANA like; that is, 74% of them would have been eligible for the clinical trial because they were symptomatic, over age 65, or younger than 65 with at least one CHADS2 stroke risk factor. About 22% of the large real-world sample would have been excluded from CABANA because they’d failed on amiodarone and other antiarrhythmic agents or had previously undergone ablation. About 4% of patients failed to meet the CABANA inclusion criteria.
The risk reduction for the composite endpoint associated with catheter ablation in the large retrospective study was greatest in the CABANA-like patients, at 30%. It was less robust but still statistically significant at 15% in patients who met at least one of the exclusion criteria for the trial.
The sheer size of this study provides greater statistical power than in CABANA. Of course, a nonrandomized, propensity score–based comparison such as this is always susceptible to confounding, even after adjustment for 90 variables. But the observational study does offer “a glimmer of hope” that catheter ablation, done in the right patients, might confer a stroke risk reduction and mortality benefit, he said.
The 33% relative risk reduction in the small group of real-world patients who failed to meet the CABANA inclusion criteria, while numerically impressive, wasn’t close to statistical significance, probably because event rates in that population were so low.
“Even if you could reduce stroke risk with ablation in that low-risk group, it would be a very inefficient way to reduce the population burden of stroke,” Dr. Noseworthy observed.
Putting together the results of CABANA and the large observational study to sum up his view of where catheter ablation for AF[ib] stands today, Dr. Noseworthy commented, “Ablation is reasonable for symptom control in many patients, basically anyone who is either breaking through on drugs or doesn’t want to take the drugs and is highly symptomatic. And there may be a small stroke and/or mortality benefit for people who are in the sweet spot – and those are people who look a lot like the patients enrolled in CABANA.”
Patients who met the exclusion criteria for CABANA are too advanced in their AFib to be likely to derive a stroke or mortality benefit from catheter ablation. “It’s very hard to move the needle in these patients with either a drug or catheter ablation approach. I wouldn’t try to reduce the risk of stroke here with an expensive and invasive procedure,” the electrophysiologist concluded.
He reported having no financial conflicts regarding his presentation.
SNOWMASS, COLO. – stroke, major bleeding, or cardiac arrest, compared with rhythm and/or rate control drugs in a propensity score–weighted, retrospective, observational study.
Findings of the investigation, which included more than 183,000 real-world patients in routine clinical practice, were reported by Peter S. Noseworthy, MD, during the annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.
The results breathe new life into the controversy created by the previously reported CABANA trial (Catheter Ablation vs. Antiarrhythmic Drug Therapy for Atrial Fibrillation), a 10-country study in which 2,204 patients with atrial fibrillation (AFib) were randomized to catheter ablation or antiarrhythmic and/or rhythm control medications and followed for a mean of about 4 years. CABANA yielded a negative result (JAMA. 2019 Apr 2;321[13]:1261-74), with the prespecified intent-to-treat analysis indicating no significant between-group difference in the primary composite endpoint – the very same one that was positive in the large observational study.
However, CABANA was marred by major problems arising from protocol deviations: Nearly 28% of patients assigned to medical therapy crossed over to catheter ablation, typically because their antiarrhythmic drugs failed, and 10% of patients randomized to catheter ablation never got it. This muddies the waters when trying to identify a true stroke/mortality benefit for catheter ablation, if indeed any such benefit was actually present.
Here’s where the controversy arose: While CABANA must be called a negative trial based upon the disappointing results of the intent-to-treat analysis, a prespecified post hoc analysis of patients as actually treated showed a statistically significant 27% relative risk reduction for the primary composite endpoint in the catheter ablation group. That’s strikingly similar to the 30% relative risk reduction for catheter ablation seen in the huge observational study, where the CABANA-type primary outcome occurred in 22.5% of the medically managed patients and 16.8% of those who underwent catheter ablation, noted Dr. Noseworthy, professor of medicine and director of heart rhythm and physiology at the Mayo Clinic in Rochester, Minn.
He ought to know: He was both an investigator in CABANA and first author of the published observational study (Eur Heart J. 2019 Apr 21;40[16]:1257-64).
In the observational study, Dr. Noseworthy and coinvestigators utilized a huge U.S. administrative health claims database in order to identify a nationally representative group of 183,760 AFib patients, 12,032 of whom were treated with catheter ablation and the rest with antiarrhythmic and/or rhythm control drugs during the same years the CABANA trial was enrolling patients. The two groups were balanced using propensity score weighting to adjust for baseline differences in 90 variables.
The investigators sought to learn if the CABANA study population was representative of real-world AFib patients, and whether the observational experience could help resolve the CABANA controversy. It turned out that most AFib patients seen in daily clinical practice were CABANA like; that is, 74% of them would have been eligible for the clinical trial because they were symptomatic, over age 65, or younger than 65 with at least one CHADS2 stroke risk factor. About 22% of the large real-world sample would have been excluded from CABANA because they’d failed on amiodarone and other antiarrhythmic agents or had previously undergone ablation. About 4% of patients failed to meet the CABANA inclusion criteria.
The risk reduction for the composite endpoint associated with catheter ablation in the large retrospective study was greatest in the CABANA-like patients, at 30%. It was less robust but still statistically significant at 15% in patients who met at least one of the exclusion criteria for the trial.
The sheer size of this study provides greater statistical power than in CABANA. Of course, a nonrandomized, propensity score–based comparison such as this is always susceptible to confounding, even after adjustment for 90 variables. But the observational study does offer “a glimmer of hope” that catheter ablation, done in the right patients, might confer a stroke risk reduction and mortality benefit, he said.
The 33% relative risk reduction in the small group of real-world patients who failed to meet the CABANA inclusion criteria, while numerically impressive, wasn’t close to statistical significance, probably because event rates in that population were so low.
“Even if you could reduce stroke risk with ablation in that low-risk group, it would be a very inefficient way to reduce the population burden of stroke,” Dr. Noseworthy observed.
Putting together the results of CABANA and the large observational study to sum up his view of where catheter ablation for AF[ib] stands today, Dr. Noseworthy commented, “Ablation is reasonable for symptom control in many patients, basically anyone who is either breaking through on drugs or doesn’t want to take the drugs and is highly symptomatic. And there may be a small stroke and/or mortality benefit for people who are in the sweet spot – and those are people who look a lot like the patients enrolled in CABANA.”
Patients who met the exclusion criteria for CABANA are too advanced in their AFib to be likely to derive a stroke or mortality benefit from catheter ablation. “It’s very hard to move the needle in these patients with either a drug or catheter ablation approach. I wouldn’t try to reduce the risk of stroke here with an expensive and invasive procedure,” the electrophysiologist concluded.
He reported having no financial conflicts regarding his presentation.
SNOWMASS, COLO. – stroke, major bleeding, or cardiac arrest, compared with rhythm and/or rate control drugs in a propensity score–weighted, retrospective, observational study.
Findings of the investigation, which included more than 183,000 real-world patients in routine clinical practice, were reported by Peter S. Noseworthy, MD, during the annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.
The results breathe new life into the controversy created by the previously reported CABANA trial (Catheter Ablation vs. Antiarrhythmic Drug Therapy for Atrial Fibrillation), a 10-country study in which 2,204 patients with atrial fibrillation (AFib) were randomized to catheter ablation or antiarrhythmic and/or rhythm control medications and followed for a mean of about 4 years. CABANA yielded a negative result (JAMA. 2019 Apr 2;321[13]:1261-74), with the prespecified intent-to-treat analysis indicating no significant between-group difference in the primary composite endpoint – the very same one that was positive in the large observational study.
However, CABANA was marred by major problems arising from protocol deviations: Nearly 28% of patients assigned to medical therapy crossed over to catheter ablation, typically because their antiarrhythmic drugs failed, and 10% of patients randomized to catheter ablation never got it. This muddies the waters when trying to identify a true stroke/mortality benefit for catheter ablation, if indeed any such benefit was actually present.
Here’s where the controversy arose: While CABANA must be called a negative trial based upon the disappointing results of the intent-to-treat analysis, a prespecified post hoc analysis of patients as actually treated showed a statistically significant 27% relative risk reduction for the primary composite endpoint in the catheter ablation group. That’s strikingly similar to the 30% relative risk reduction for catheter ablation seen in the huge observational study, where the CABANA-type primary outcome occurred in 22.5% of the medically managed patients and 16.8% of those who underwent catheter ablation, noted Dr. Noseworthy, professor of medicine and director of heart rhythm and physiology at the Mayo Clinic in Rochester, Minn.
He ought to know: He was both an investigator in CABANA and first author of the published observational study (Eur Heart J. 2019 Apr 21;40[16]:1257-64).
In the observational study, Dr. Noseworthy and coinvestigators utilized a huge U.S. administrative health claims database in order to identify a nationally representative group of 183,760 AFib patients, 12,032 of whom were treated with catheter ablation and the rest with antiarrhythmic and/or rhythm control drugs during the same years the CABANA trial was enrolling patients. The two groups were balanced using propensity score weighting to adjust for baseline differences in 90 variables.
The investigators sought to learn if the CABANA study population was representative of real-world AFib patients, and whether the observational experience could help resolve the CABANA controversy. It turned out that most AFib patients seen in daily clinical practice were CABANA like; that is, 74% of them would have been eligible for the clinical trial because they were symptomatic, over age 65, or younger than 65 with at least one CHADS2 stroke risk factor. About 22% of the large real-world sample would have been excluded from CABANA because they’d failed on amiodarone and other antiarrhythmic agents or had previously undergone ablation. About 4% of patients failed to meet the CABANA inclusion criteria.
The risk reduction for the composite endpoint associated with catheter ablation in the large retrospective study was greatest in the CABANA-like patients, at 30%. It was less robust but still statistically significant at 15% in patients who met at least one of the exclusion criteria for the trial.
The sheer size of this study provides greater statistical power than in CABANA. Of course, a nonrandomized, propensity score–based comparison such as this is always susceptible to confounding, even after adjustment for 90 variables. But the observational study does offer “a glimmer of hope” that catheter ablation, done in the right patients, might confer a stroke risk reduction and mortality benefit, he said.
The 33% relative risk reduction in the small group of real-world patients who failed to meet the CABANA inclusion criteria, while numerically impressive, wasn’t close to statistical significance, probably because event rates in that population were so low.
“Even if you could reduce stroke risk with ablation in that low-risk group, it would be a very inefficient way to reduce the population burden of stroke,” Dr. Noseworthy observed.
Putting together the results of CABANA and the large observational study to sum up his view of where catheter ablation for AF[ib] stands today, Dr. Noseworthy commented, “Ablation is reasonable for symptom control in many patients, basically anyone who is either breaking through on drugs or doesn’t want to take the drugs and is highly symptomatic. And there may be a small stroke and/or mortality benefit for people who are in the sweet spot – and those are people who look a lot like the patients enrolled in CABANA.”
Patients who met the exclusion criteria for CABANA are too advanced in their AFib to be likely to derive a stroke or mortality benefit from catheter ablation. “It’s very hard to move the needle in these patients with either a drug or catheter ablation approach. I wouldn’t try to reduce the risk of stroke here with an expensive and invasive procedure,” the electrophysiologist concluded.
He reported having no financial conflicts regarding his presentation.
REPORTING FROM ACC SNOWMASS 2020
Vitiligo tied to lower risk of internal malignancies
LAHAINA, HAWAII – from South Korea, Iltefat Hamzavi, MD, said at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
Previous studies by Dr. Hamzavi and others have established that vitiligo patients have a reduced risk of melanoma and perhaps nonmelanoma skin cancers as well. But the South Korean national study of 101,078 vitiligo patients matched by age and sex to twice as many vitiligo-free controls was the first large examination of the association between vitiligo and internal malignancies. The findings suggest that immunosurveillance in patients with the disease is not merely a skin-deep phenomenon, noted Dr. Hamzavi, of the MultiCultural Dermatology Center at Henry Ford Hospital in Detroit.
“Vitiligo is probably a systemic disease in which there may be increased immunosurveillance. The point here is that as we suppress the disease, we have to be careful that we’re not going to increase cancer rates,” the dermatologist explained in an interview. “This is big data, and something to be aware of, but don’t act on it yet in clinical practice. I just want people to be aware that all of these autoimmune diseases are there for a reason. There are lower rates of melanoma and internal cancers in patients who have vitiligo, but what that means for our new therapies that are coming up we don’t know yet.”
He predicted that the study will open up an active new research domain, but it will take time to find definitive answers as to whether emerging immunomodulatory therapies for patients with vitiligo might, in some instances, increase their current favorably lower risk of internal malignancies. In the meantime, physicians interested in treating vitiligo off label with, for example, Janus kinase (JAK) inhibitors will want to be particularly cautious in patients with a strong history of skin cancer or internal malignancies.
The retrospective, population-based study utilized data from the Korean National Health Insurance claims database. The investigators found that the incidence rate of internal malignancies was 612.9 per 100,000 person-years in the vitiligo group and 708.9 per 100,000 person-years in controls, for a statistically significant and clinically meaningful 14% relative risk reduction after adjustment for age, sex, and comorbid conditions.
Among the most striking organ-specific findings: the vitiligo group had a 38% relative risk reduction in colorectal cancer, a 25% reduction in the risk of lung cancer, and a 38% decrease in ovarian cancer. In contrast, they had a 20% increase in the risk of thyroid cancer (J Clin Oncol. 2019 Apr 10;37[11]:903-11).
Despite the fact that vitiligo is a common disease that affects 0.5%-1% of the population worldwide, for decades it has been something of a pharmacotherapeutic backwater. That’s changed recently and in dramatic fashion as a result of new understanding of the disease pathogenesis. The JAK inhibitors are now under active investigation for the treatment of vitiligo. Indeed, ruxolitinib cream, a potent JAK-1 and -2 inhibitor, is now in phase 3 investigation following a highly successful phase 2 trial. Interleukin-15 blockade is another promising avenue.
Dr. Hamzavi reported serving as a consultant to AbbVie, Aclaris, Novartis, and Pfizer, and receiving research funding from Estee Lauder, Clinuvel Pharmaceuticals, Incyte, and Pfizer. SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
LAHAINA, HAWAII – from South Korea, Iltefat Hamzavi, MD, said at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
Previous studies by Dr. Hamzavi and others have established that vitiligo patients have a reduced risk of melanoma and perhaps nonmelanoma skin cancers as well. But the South Korean national study of 101,078 vitiligo patients matched by age and sex to twice as many vitiligo-free controls was the first large examination of the association between vitiligo and internal malignancies. The findings suggest that immunosurveillance in patients with the disease is not merely a skin-deep phenomenon, noted Dr. Hamzavi, of the MultiCultural Dermatology Center at Henry Ford Hospital in Detroit.
“Vitiligo is probably a systemic disease in which there may be increased immunosurveillance. The point here is that as we suppress the disease, we have to be careful that we’re not going to increase cancer rates,” the dermatologist explained in an interview. “This is big data, and something to be aware of, but don’t act on it yet in clinical practice. I just want people to be aware that all of these autoimmune diseases are there for a reason. There are lower rates of melanoma and internal cancers in patients who have vitiligo, but what that means for our new therapies that are coming up we don’t know yet.”
He predicted that the study will open up an active new research domain, but it will take time to find definitive answers as to whether emerging immunomodulatory therapies for patients with vitiligo might, in some instances, increase their current favorably lower risk of internal malignancies. In the meantime, physicians interested in treating vitiligo off label with, for example, Janus kinase (JAK) inhibitors will want to be particularly cautious in patients with a strong history of skin cancer or internal malignancies.
The retrospective, population-based study utilized data from the Korean National Health Insurance claims database. The investigators found that the incidence rate of internal malignancies was 612.9 per 100,000 person-years in the vitiligo group and 708.9 per 100,000 person-years in controls, for a statistically significant and clinically meaningful 14% relative risk reduction after adjustment for age, sex, and comorbid conditions.
Among the most striking organ-specific findings: the vitiligo group had a 38% relative risk reduction in colorectal cancer, a 25% reduction in the risk of lung cancer, and a 38% decrease in ovarian cancer. In contrast, they had a 20% increase in the risk of thyroid cancer (J Clin Oncol. 2019 Apr 10;37[11]:903-11).
Despite the fact that vitiligo is a common disease that affects 0.5%-1% of the population worldwide, for decades it has been something of a pharmacotherapeutic backwater. That’s changed recently and in dramatic fashion as a result of new understanding of the disease pathogenesis. The JAK inhibitors are now under active investigation for the treatment of vitiligo. Indeed, ruxolitinib cream, a potent JAK-1 and -2 inhibitor, is now in phase 3 investigation following a highly successful phase 2 trial. Interleukin-15 blockade is another promising avenue.
Dr. Hamzavi reported serving as a consultant to AbbVie, Aclaris, Novartis, and Pfizer, and receiving research funding from Estee Lauder, Clinuvel Pharmaceuticals, Incyte, and Pfizer. SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
LAHAINA, HAWAII – from South Korea, Iltefat Hamzavi, MD, said at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
Previous studies by Dr. Hamzavi and others have established that vitiligo patients have a reduced risk of melanoma and perhaps nonmelanoma skin cancers as well. But the South Korean national study of 101,078 vitiligo patients matched by age and sex to twice as many vitiligo-free controls was the first large examination of the association between vitiligo and internal malignancies. The findings suggest that immunosurveillance in patients with the disease is not merely a skin-deep phenomenon, noted Dr. Hamzavi, of the MultiCultural Dermatology Center at Henry Ford Hospital in Detroit.
“Vitiligo is probably a systemic disease in which there may be increased immunosurveillance. The point here is that as we suppress the disease, we have to be careful that we’re not going to increase cancer rates,” the dermatologist explained in an interview. “This is big data, and something to be aware of, but don’t act on it yet in clinical practice. I just want people to be aware that all of these autoimmune diseases are there for a reason. There are lower rates of melanoma and internal cancers in patients who have vitiligo, but what that means for our new therapies that are coming up we don’t know yet.”
He predicted that the study will open up an active new research domain, but it will take time to find definitive answers as to whether emerging immunomodulatory therapies for patients with vitiligo might, in some instances, increase their current favorably lower risk of internal malignancies. In the meantime, physicians interested in treating vitiligo off label with, for example, Janus kinase (JAK) inhibitors will want to be particularly cautious in patients with a strong history of skin cancer or internal malignancies.
The retrospective, population-based study utilized data from the Korean National Health Insurance claims database. The investigators found that the incidence rate of internal malignancies was 612.9 per 100,000 person-years in the vitiligo group and 708.9 per 100,000 person-years in controls, for a statistically significant and clinically meaningful 14% relative risk reduction after adjustment for age, sex, and comorbid conditions.
Among the most striking organ-specific findings: the vitiligo group had a 38% relative risk reduction in colorectal cancer, a 25% reduction in the risk of lung cancer, and a 38% decrease in ovarian cancer. In contrast, they had a 20% increase in the risk of thyroid cancer (J Clin Oncol. 2019 Apr 10;37[11]:903-11).
Despite the fact that vitiligo is a common disease that affects 0.5%-1% of the population worldwide, for decades it has been something of a pharmacotherapeutic backwater. That’s changed recently and in dramatic fashion as a result of new understanding of the disease pathogenesis. The JAK inhibitors are now under active investigation for the treatment of vitiligo. Indeed, ruxolitinib cream, a potent JAK-1 and -2 inhibitor, is now in phase 3 investigation following a highly successful phase 2 trial. Interleukin-15 blockade is another promising avenue.
Dr. Hamzavi reported serving as a consultant to AbbVie, Aclaris, Novartis, and Pfizer, and receiving research funding from Estee Lauder, Clinuvel Pharmaceuticals, Incyte, and Pfizer. SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
REPORTING FROM SDEF HAWAII DERMATOLOGY SEMINAR
Dupilumab for severe AD: Expert advocates continuous treatment
LAHAINA, HAWAII – rather than treatment on an as-needed basis, Andrew Blauvelt, MD, advised at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
“I view atopic dermatitis as a chronic disease requiring chronic treatment. So be very careful about stopping. We know that if you start and stop biologics you’re going to be far more prone to develop antidrug antibodies resulting in drug resistance than with continual dosing,” said Dr. Blauvelt, a dermatologist and clinical trialist who is president of the Oregon Medical Research Center, Portland.
He said dupilumab (Dupixent) seldom induces disease remission as defined by clear skin while off all drugs for at least 1 year, although he has a few patients who seem to be exceptions. Yet clearly dupilumab doesn’t change an individual’s predisposing genetics or environmental allergen exposure pattern, so it’s best to think of it as a treatment for the long haul.
Dr. Blauvelt considers dupilumab far and away the best medication for treatment of adults and teenagers whose atopic dermatitis (AD) is uncontrolled with topical therapy. Payers often balk at authorizing dupilumab unless a patient has first undergone an unsuccessful trial of cyclosporine or methotrexate, which are far less expensive. But that’s not what the expert consensus guidelines recommend (Ann Allergy Asthma Immunol. 2018 Jan;120[1]:10-22.e2).
“The guidelines don’t suggest that failure on methotrexate or cyclosporine should be a prerequisite for dupilumab. So if you’re having problems with an insurance company and you really want to use dupilumab, you can point to this paper and say, ‘Look, the experts do not recommend step therapy, we can go directly to dupilumab.’ And the dupilumab label says simply that failure of topical therapy is required before being allowed to use dupilumab. So both the label and the experts say you don’t have to go through a bunch of steps in order to get to what I consider the very best drug for our patients,” he explained.
Both cyclosporine and methotrexate are far more broadly immunosuppressive and hence less safe than dupilumab. Both require laboratory monitoring. In contrast, blood work isn’t required in patients on dupilumab; in fact, Dr. Blauvelt considers it an unwise use of resources. Nor is tuberculosis testing advised prior to starting dupilumab.
When he can’t get authorization for dupilumab, Dr. Blauvelt’s go-to drug is methotrexate at 15-25 mg/week. It’s not as effective as cyclosporine for rapid clearing, but it’s safer for long-term use.
“Methotrexate is the devil we know – we know how to use it, and we know how to monitor for it,” he commented, adding that he reserves cyclosporine for a maximum of a month or 2 of acute crisis management, or as a bridge in getting patients off of systemic corticosteroids.
Set realistic efficacy expectations
Dermatologists who prescribe the newest biologics for psoriasis are accustomed to routinely seeing PASI 90 responses and even complete disease clearing. However, AD is a more challenging disease. In the landmark dupilumab phase 3 randomized trials, roughly two-thirds of patients achieved an Eczema Area and Severity Index (EASI) 75 response, with a mean 80% improvement in EASI symptom scores over baseline. Roughly 20% of dupilumab-treated adults with AD achieve disease clearance, and a similar percentage become almost clear. The improvements are durable in long-term follow-up studies.
“Dupilumab doesn’t get a lot of people to zero. They’re not going to be completely clearing their eczema. So they shouldn’t be freaking out if they still have eczema. What they can expect is diminution of the disease to much lower levels,” Dr. Blauvelt said.
The marked improvement in quality of life that occurs with dupilumab therapy isn’t adequately captured by EASI scores. “In my experience, more than 80%-90% of patients are happy on this drug,” Dr. Blauvelt said.
Conference codirector Linda Stein Gold, MD, agreed, commenting that she has found dupilumab to be “absolutely life altering” for her patients with severe AD.
“They know they still have AD, but now they can go whole days without thinking about it,” said Dr. Stein Gold, director of dermatology research and head of the division of dermatology at the Henry Ford Health System in Detroit.
Dr. Blauvelt noted that most of his patients on dupilumab remain on topical therapy, typically with triamcinolone on the body and hydrocortisone on the face. What he terms “miniflares” in patients on dupilumab are not at all unusual, but they’re readily manageable.
“Flares that used to last for weeks now last for a day or 2, maybe 3, and then it’s back to normal in patients on dupilumab,” Dr. Blauvelt said.
Safety
Dupilumab is a targeted inhibitor of interleukins-4 and -13, cytokines involved in allergy-mediated inflammation and the control of parasitic infections, but which have no bearing on control of bacterial or viral infections or malignancies. Indeed, the randomized trials have demonstrated that the incidence of skin infections is actually lower with dupilumab than with placebo.
“You’re improving the skin barrier so much that they’re not going to be getting staph or herpes simplex,” he explained.
The main side effect consists of dupilumab-associated eye issues. These occur in up to 20% of treated patients and encompass a spectrum ranging from dry eye to nonallergic conjunctivitis, inflammation of the eyelid, and keratitis. The mechanism is unknown. The condition is not infectious and doesn’t affect vision. Intriguingly, it doesn’t occur in patients with asthma, a disease for which dupilumab is also approved.
“Ask about eye issues at every office visit,” the dermatologist urged.
He sends all of his AD patients with dupilumab-associated eye issues to a single trusted local ophthalmologist and lets him manage the condition, which is generally mild to moderate. Eye issues have resulted in discontinuation of dupilumab in only 2 of the roughly 150 AD patients Dr. Blauvelt has placed on the biologic. The ophthalmologist generally relies upon lubricating eye drops and a couple of weeks of steroid eye drops or, in some cases, topical cyclosporine 0.05% ophthalmic emulsion, followed by episodic use of the steroid eye drops on an as-needed basis.
Residual facial disease in AD patients on dupilumab can be caused by a variety of causes, including breakthrough AD, rosacea, allergic contact dermatitis, steroid withdrawal, or photosensitivity, with Demodex thought to play a role in some cases.
Dr. Blauvelt reported serving as a scientific adviser to and paid clinical trial investigator for several dozen pharmaceutical companies. SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
LAHAINA, HAWAII – rather than treatment on an as-needed basis, Andrew Blauvelt, MD, advised at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
“I view atopic dermatitis as a chronic disease requiring chronic treatment. So be very careful about stopping. We know that if you start and stop biologics you’re going to be far more prone to develop antidrug antibodies resulting in drug resistance than with continual dosing,” said Dr. Blauvelt, a dermatologist and clinical trialist who is president of the Oregon Medical Research Center, Portland.
He said dupilumab (Dupixent) seldom induces disease remission as defined by clear skin while off all drugs for at least 1 year, although he has a few patients who seem to be exceptions. Yet clearly dupilumab doesn’t change an individual’s predisposing genetics or environmental allergen exposure pattern, so it’s best to think of it as a treatment for the long haul.
Dr. Blauvelt considers dupilumab far and away the best medication for treatment of adults and teenagers whose atopic dermatitis (AD) is uncontrolled with topical therapy. Payers often balk at authorizing dupilumab unless a patient has first undergone an unsuccessful trial of cyclosporine or methotrexate, which are far less expensive. But that’s not what the expert consensus guidelines recommend (Ann Allergy Asthma Immunol. 2018 Jan;120[1]:10-22.e2).
“The guidelines don’t suggest that failure on methotrexate or cyclosporine should be a prerequisite for dupilumab. So if you’re having problems with an insurance company and you really want to use dupilumab, you can point to this paper and say, ‘Look, the experts do not recommend step therapy, we can go directly to dupilumab.’ And the dupilumab label says simply that failure of topical therapy is required before being allowed to use dupilumab. So both the label and the experts say you don’t have to go through a bunch of steps in order to get to what I consider the very best drug for our patients,” he explained.
Both cyclosporine and methotrexate are far more broadly immunosuppressive and hence less safe than dupilumab. Both require laboratory monitoring. In contrast, blood work isn’t required in patients on dupilumab; in fact, Dr. Blauvelt considers it an unwise use of resources. Nor is tuberculosis testing advised prior to starting dupilumab.
When he can’t get authorization for dupilumab, Dr. Blauvelt’s go-to drug is methotrexate at 15-25 mg/week. It’s not as effective as cyclosporine for rapid clearing, but it’s safer for long-term use.
“Methotrexate is the devil we know – we know how to use it, and we know how to monitor for it,” he commented, adding that he reserves cyclosporine for a maximum of a month or 2 of acute crisis management, or as a bridge in getting patients off of systemic corticosteroids.
Set realistic efficacy expectations
Dermatologists who prescribe the newest biologics for psoriasis are accustomed to routinely seeing PASI 90 responses and even complete disease clearing. However, AD is a more challenging disease. In the landmark dupilumab phase 3 randomized trials, roughly two-thirds of patients achieved an Eczema Area and Severity Index (EASI) 75 response, with a mean 80% improvement in EASI symptom scores over baseline. Roughly 20% of dupilumab-treated adults with AD achieve disease clearance, and a similar percentage become almost clear. The improvements are durable in long-term follow-up studies.
“Dupilumab doesn’t get a lot of people to zero. They’re not going to be completely clearing their eczema. So they shouldn’t be freaking out if they still have eczema. What they can expect is diminution of the disease to much lower levels,” Dr. Blauvelt said.
The marked improvement in quality of life that occurs with dupilumab therapy isn’t adequately captured by EASI scores. “In my experience, more than 80%-90% of patients are happy on this drug,” Dr. Blauvelt said.
Conference codirector Linda Stein Gold, MD, agreed, commenting that she has found dupilumab to be “absolutely life altering” for her patients with severe AD.
“They know they still have AD, but now they can go whole days without thinking about it,” said Dr. Stein Gold, director of dermatology research and head of the division of dermatology at the Henry Ford Health System in Detroit.
Dr. Blauvelt noted that most of his patients on dupilumab remain on topical therapy, typically with triamcinolone on the body and hydrocortisone on the face. What he terms “miniflares” in patients on dupilumab are not at all unusual, but they’re readily manageable.
“Flares that used to last for weeks now last for a day or 2, maybe 3, and then it’s back to normal in patients on dupilumab,” Dr. Blauvelt said.
Safety
Dupilumab is a targeted inhibitor of interleukins-4 and -13, cytokines involved in allergy-mediated inflammation and the control of parasitic infections, but which have no bearing on control of bacterial or viral infections or malignancies. Indeed, the randomized trials have demonstrated that the incidence of skin infections is actually lower with dupilumab than with placebo.
“You’re improving the skin barrier so much that they’re not going to be getting staph or herpes simplex,” he explained.
The main side effect consists of dupilumab-associated eye issues. These occur in up to 20% of treated patients and encompass a spectrum ranging from dry eye to nonallergic conjunctivitis, inflammation of the eyelid, and keratitis. The mechanism is unknown. The condition is not infectious and doesn’t affect vision. Intriguingly, it doesn’t occur in patients with asthma, a disease for which dupilumab is also approved.
“Ask about eye issues at every office visit,” the dermatologist urged.
He sends all of his AD patients with dupilumab-associated eye issues to a single trusted local ophthalmologist and lets him manage the condition, which is generally mild to moderate. Eye issues have resulted in discontinuation of dupilumab in only 2 of the roughly 150 AD patients Dr. Blauvelt has placed on the biologic. The ophthalmologist generally relies upon lubricating eye drops and a couple of weeks of steroid eye drops or, in some cases, topical cyclosporine 0.05% ophthalmic emulsion, followed by episodic use of the steroid eye drops on an as-needed basis.
Residual facial disease in AD patients on dupilumab can be caused by a variety of causes, including breakthrough AD, rosacea, allergic contact dermatitis, steroid withdrawal, or photosensitivity, with Demodex thought to play a role in some cases.
Dr. Blauvelt reported serving as a scientific adviser to and paid clinical trial investigator for several dozen pharmaceutical companies. SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
LAHAINA, HAWAII – rather than treatment on an as-needed basis, Andrew Blauvelt, MD, advised at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
“I view atopic dermatitis as a chronic disease requiring chronic treatment. So be very careful about stopping. We know that if you start and stop biologics you’re going to be far more prone to develop antidrug antibodies resulting in drug resistance than with continual dosing,” said Dr. Blauvelt, a dermatologist and clinical trialist who is president of the Oregon Medical Research Center, Portland.
He said dupilumab (Dupixent) seldom induces disease remission as defined by clear skin while off all drugs for at least 1 year, although he has a few patients who seem to be exceptions. Yet clearly dupilumab doesn’t change an individual’s predisposing genetics or environmental allergen exposure pattern, so it’s best to think of it as a treatment for the long haul.
Dr. Blauvelt considers dupilumab far and away the best medication for treatment of adults and teenagers whose atopic dermatitis (AD) is uncontrolled with topical therapy. Payers often balk at authorizing dupilumab unless a patient has first undergone an unsuccessful trial of cyclosporine or methotrexate, which are far less expensive. But that’s not what the expert consensus guidelines recommend (Ann Allergy Asthma Immunol. 2018 Jan;120[1]:10-22.e2).
“The guidelines don’t suggest that failure on methotrexate or cyclosporine should be a prerequisite for dupilumab. So if you’re having problems with an insurance company and you really want to use dupilumab, you can point to this paper and say, ‘Look, the experts do not recommend step therapy, we can go directly to dupilumab.’ And the dupilumab label says simply that failure of topical therapy is required before being allowed to use dupilumab. So both the label and the experts say you don’t have to go through a bunch of steps in order to get to what I consider the very best drug for our patients,” he explained.
Both cyclosporine and methotrexate are far more broadly immunosuppressive and hence less safe than dupilumab. Both require laboratory monitoring. In contrast, blood work isn’t required in patients on dupilumab; in fact, Dr. Blauvelt considers it an unwise use of resources. Nor is tuberculosis testing advised prior to starting dupilumab.
When he can’t get authorization for dupilumab, Dr. Blauvelt’s go-to drug is methotrexate at 15-25 mg/week. It’s not as effective as cyclosporine for rapid clearing, but it’s safer for long-term use.
“Methotrexate is the devil we know – we know how to use it, and we know how to monitor for it,” he commented, adding that he reserves cyclosporine for a maximum of a month or 2 of acute crisis management, or as a bridge in getting patients off of systemic corticosteroids.
Set realistic efficacy expectations
Dermatologists who prescribe the newest biologics for psoriasis are accustomed to routinely seeing PASI 90 responses and even complete disease clearing. However, AD is a more challenging disease. In the landmark dupilumab phase 3 randomized trials, roughly two-thirds of patients achieved an Eczema Area and Severity Index (EASI) 75 response, with a mean 80% improvement in EASI symptom scores over baseline. Roughly 20% of dupilumab-treated adults with AD achieve disease clearance, and a similar percentage become almost clear. The improvements are durable in long-term follow-up studies.
“Dupilumab doesn’t get a lot of people to zero. They’re not going to be completely clearing their eczema. So they shouldn’t be freaking out if they still have eczema. What they can expect is diminution of the disease to much lower levels,” Dr. Blauvelt said.
The marked improvement in quality of life that occurs with dupilumab therapy isn’t adequately captured by EASI scores. “In my experience, more than 80%-90% of patients are happy on this drug,” Dr. Blauvelt said.
Conference codirector Linda Stein Gold, MD, agreed, commenting that she has found dupilumab to be “absolutely life altering” for her patients with severe AD.
“They know they still have AD, but now they can go whole days without thinking about it,” said Dr. Stein Gold, director of dermatology research and head of the division of dermatology at the Henry Ford Health System in Detroit.
Dr. Blauvelt noted that most of his patients on dupilumab remain on topical therapy, typically with triamcinolone on the body and hydrocortisone on the face. What he terms “miniflares” in patients on dupilumab are not at all unusual, but they’re readily manageable.
“Flares that used to last for weeks now last for a day or 2, maybe 3, and then it’s back to normal in patients on dupilumab,” Dr. Blauvelt said.
Safety
Dupilumab is a targeted inhibitor of interleukins-4 and -13, cytokines involved in allergy-mediated inflammation and the control of parasitic infections, but which have no bearing on control of bacterial or viral infections or malignancies. Indeed, the randomized trials have demonstrated that the incidence of skin infections is actually lower with dupilumab than with placebo.
“You’re improving the skin barrier so much that they’re not going to be getting staph or herpes simplex,” he explained.
The main side effect consists of dupilumab-associated eye issues. These occur in up to 20% of treated patients and encompass a spectrum ranging from dry eye to nonallergic conjunctivitis, inflammation of the eyelid, and keratitis. The mechanism is unknown. The condition is not infectious and doesn’t affect vision. Intriguingly, it doesn’t occur in patients with asthma, a disease for which dupilumab is also approved.
“Ask about eye issues at every office visit,” the dermatologist urged.
He sends all of his AD patients with dupilumab-associated eye issues to a single trusted local ophthalmologist and lets him manage the condition, which is generally mild to moderate. Eye issues have resulted in discontinuation of dupilumab in only 2 of the roughly 150 AD patients Dr. Blauvelt has placed on the biologic. The ophthalmologist generally relies upon lubricating eye drops and a couple of weeks of steroid eye drops or, in some cases, topical cyclosporine 0.05% ophthalmic emulsion, followed by episodic use of the steroid eye drops on an as-needed basis.
Residual facial disease in AD patients on dupilumab can be caused by a variety of causes, including breakthrough AD, rosacea, allergic contact dermatitis, steroid withdrawal, or photosensitivity, with Demodex thought to play a role in some cases.
Dr. Blauvelt reported serving as a scientific adviser to and paid clinical trial investigator for several dozen pharmaceutical companies. SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
EXPERT OPINION FROM SDEF HAWAII DERMATOLOGY SEMINAR
Tools for preventing heart failure
SNOWMASS, COLO. – If ever there was a major chronic disease that’s teed up and ready to be stamped into submission through diligent application of preventive medicine, it’s the epidemic of heart failure.
“The best way to treat heart failure is to prevent it in the first place. There will be more than 1 million new cases of heart failure this year, and the vast majority of them could have been prevented,” Gregg C. Fonarow, MD, asserted at the annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.
Using firmly evidence-based, guideline-directed therapies, it’s often possible to prevent patients at high risk for developing heart failure (HF) from actually doing so. Or, in the terminology of the ACC/American Heart Association heart failure guidelines coauthored by Dr. Fonarow, the goal is to keep patients who are stage A – that is, pre-HF but at high risk because of hypertension, coronary artery disease, diabetes, family history of cardiomyopathy, or other reasons – from progressing to stage B, marked by asymptomatic left ventricular dysfunction, a prior MI, or asymptomatic valvular disease; and blocking those who are stage B from then moving on to stage C, the classic symptomatic form of HF; and thence to end-stage stage D disease.
Heart failure is an enormous public health problem, and one of the most expensive of all diseases. The prognostic impact of newly diagnosed HF is profound, with 10-15 years of life lost, compared with the general population. Even today, roughly one in five newly diagnosed patients won’t survive for a year, and the 5-year mortality is about 50%, said Dr. Fonarow, who is professor of cardiovascular medicine and chief of the division of cardiology at the University of California, Los Angeles, and director of the Ahmanson-UCLA Cardiomyopathy Center, also in Los Angeles.
Symptomatic stage C is “the tip of the iceberg,” the cardiologist stressed. Vastly more patients are in stages A and B. In order to keep them from progressing to stage C, it’s first necessary to identify them. That’s why the 2013 guidelines give a class IC recommendation for periodic evaluation for signs and symptoms of HF in patients who are at high risk, and for a noninvasive assessment of left ventricular ejection fraction in those with a strong family history of cardiomyopathy or who are on cardiotoxic drugs (J Am Coll Cardiol. 2013 Oct 15;62[16]:e147-239).
The two biggest risk factors for the development of symptomatic stage C HF are hypertension and atherosclerotic cardiovascular disease. Close to 80% of patients presenting with heart failure have prevalent hypertension, and a history of ischemic heart disease is nearly as common.
Other major modifiable risk factors are diabetes, overweight and obesity, metabolic syndrome, dyslipidemia, smoking, valvular heart disease, and chronic kidney disease.
Hypertension
Most patients with high blood pressure believe they’re on antihypertensive medication to prevent MI and stroke, but in reality the largest benefit is what Dr. Fonarow termed the “phenomenal” reduction in the risk of developing HF, which amounted to a 52% relative risk reduction in one meta-analysis of older randomized trials. In the contemporary era, the landmark SPRINT trial of close to 10,000 randomized hypertensive patients showed that more-intensive blood pressure lowering to a target systolic BP of less than 120 mm Hg resulted in a 38% reduction in the risk of new-onset HF, compared with standard treatment to a target of less than 140 mm Hg. That’s why the 2017 focused update of the HF guidelines gives a strong class IB recommendation for a target blood pressure of less than 130/80 mm Hg in hypertensive patients with stage A HF (J Am Coll Cardiol. 2017 Aug 8;70[6]:776-803).
Atherosclerotic cardiovascular disease
Within 6 years after diagnosis of an MI, 22% of men and 46% of women will develop symptomatic heart failure. Intensive statin therapy gets a strong recommendation post MI in the guidelines, not only because in a meta-analysis of four major randomized trials it resulted in a further 64% reduction in the risk of coronary death or recurrent MI, compared with moderate statin therapy, but also because of the 27% relative risk reduction in new-onset HF. ACE inhibitors get a class IA recommendation for prevention of symptomatic HF in patients who are stage A with a history of atherosclerotic disease, diabetes, or hypertension. Angiotensin receptor blockers get a class IC recommendation.
Diabetes
Diabetes markedly increases the risk of developing HF: by two to four times overall and by four to eight times in younger diabetes patients. The two chronic diseases are highly comorbid, with roughly 45% of patients with HF also having diabetes. Moreover, diabetes in HF patients is associated with a substantially worse prognosis, even when standard HF therapies are applied.
Choices regarding glycemic management can markedly affect HF risk and outcomes. Randomized trials show that the peroxisome proliferator-activated receptor agonists double the risk of HF. The glucagonlike peptide–1 receptor agonists are absolutely neutral with regard to HF outcomes. Similarly, the dipeptidyl peptidase–4 inhibitors have no impact on the risks of major adverse cardiovascular events or HF. Intensive glycemic control has no impact on the risk of new-onset HF. Insulin therapy, too, is neutral on this score.
“Depressingly, even lifestyle modification with weight loss, once you have type 2 diabetes, does not lower the risk,” Dr. Fonarow continued.
In contrast, the sodium-glucose transporter 2 (SGLT2) inhibitors have impressive cardiovascular and renal protective benefits in patients with type 2 diabetes, as demonstrated in a meta-analysis of more than 34,000 participants in the randomized trials of empagliflozin (Jardiance) in EMPA-REG OUTCOME, canagliflozin (Invokana) in CANVAS/CANVAS-R, and dapagliflozin (Farxiga) in DECLARE-TIMI 58. The SGLT2 inhibitors collectively reduced the risk of HF hospitalization by 21% in participants with no baseline history of the disease and by 29% in those with a history of HF. Moreover, the risk of progression of renal disease was reduced by 45% (Lancet. 2019 Jan 5;393[10166]:31-9).
More recently, the landmark DAPA-HF trial established SGLT2 inhibitor therapy as part of standard-of-care, guideline-directed medical therapy for patients with HF with reduced ejection fraction regardless of whether they have comorbid type 2 diabetes (N Engl J Med. 2019 Nov 21;381[21]:1995-2008).
These are remarkable medications, generally very well tolerated, and it’s critical that cardiologists get on board in prescribing them, Dr. Fonarow emphasized. He alerted his colleagues to what he called an “incredibly helpful” review article that provides practical guidance for cardiologists in how to start using the SGLT2 inhibitors (JACC Heart Fail. 2019 Feb;7[2]:169-72).
“It’s pretty straightforward,” according to Dr. Fonarow. “If you’re comfortable enough in using ACE inhibitors, angiotensin receptor blockers, and beta-blockers, I think you’ll find these medications fit similarly when you actually get experience in utilizing them.”
He reported serving as a consultant to 10 pharmaceutical or medical device companies.
SNOWMASS, COLO. – If ever there was a major chronic disease that’s teed up and ready to be stamped into submission through diligent application of preventive medicine, it’s the epidemic of heart failure.
“The best way to treat heart failure is to prevent it in the first place. There will be more than 1 million new cases of heart failure this year, and the vast majority of them could have been prevented,” Gregg C. Fonarow, MD, asserted at the annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.
Using firmly evidence-based, guideline-directed therapies, it’s often possible to prevent patients at high risk for developing heart failure (HF) from actually doing so. Or, in the terminology of the ACC/American Heart Association heart failure guidelines coauthored by Dr. Fonarow, the goal is to keep patients who are stage A – that is, pre-HF but at high risk because of hypertension, coronary artery disease, diabetes, family history of cardiomyopathy, or other reasons – from progressing to stage B, marked by asymptomatic left ventricular dysfunction, a prior MI, or asymptomatic valvular disease; and blocking those who are stage B from then moving on to stage C, the classic symptomatic form of HF; and thence to end-stage stage D disease.
Heart failure is an enormous public health problem, and one of the most expensive of all diseases. The prognostic impact of newly diagnosed HF is profound, with 10-15 years of life lost, compared with the general population. Even today, roughly one in five newly diagnosed patients won’t survive for a year, and the 5-year mortality is about 50%, said Dr. Fonarow, who is professor of cardiovascular medicine and chief of the division of cardiology at the University of California, Los Angeles, and director of the Ahmanson-UCLA Cardiomyopathy Center, also in Los Angeles.
Symptomatic stage C is “the tip of the iceberg,” the cardiologist stressed. Vastly more patients are in stages A and B. In order to keep them from progressing to stage C, it’s first necessary to identify them. That’s why the 2013 guidelines give a class IC recommendation for periodic evaluation for signs and symptoms of HF in patients who are at high risk, and for a noninvasive assessment of left ventricular ejection fraction in those with a strong family history of cardiomyopathy or who are on cardiotoxic drugs (J Am Coll Cardiol. 2013 Oct 15;62[16]:e147-239).
The two biggest risk factors for the development of symptomatic stage C HF are hypertension and atherosclerotic cardiovascular disease. Close to 80% of patients presenting with heart failure have prevalent hypertension, and a history of ischemic heart disease is nearly as common.
Other major modifiable risk factors are diabetes, overweight and obesity, metabolic syndrome, dyslipidemia, smoking, valvular heart disease, and chronic kidney disease.
Hypertension
Most patients with high blood pressure believe they’re on antihypertensive medication to prevent MI and stroke, but in reality the largest benefit is what Dr. Fonarow termed the “phenomenal” reduction in the risk of developing HF, which amounted to a 52% relative risk reduction in one meta-analysis of older randomized trials. In the contemporary era, the landmark SPRINT trial of close to 10,000 randomized hypertensive patients showed that more-intensive blood pressure lowering to a target systolic BP of less than 120 mm Hg resulted in a 38% reduction in the risk of new-onset HF, compared with standard treatment to a target of less than 140 mm Hg. That’s why the 2017 focused update of the HF guidelines gives a strong class IB recommendation for a target blood pressure of less than 130/80 mm Hg in hypertensive patients with stage A HF (J Am Coll Cardiol. 2017 Aug 8;70[6]:776-803).
Atherosclerotic cardiovascular disease
Within 6 years after diagnosis of an MI, 22% of men and 46% of women will develop symptomatic heart failure. Intensive statin therapy gets a strong recommendation post MI in the guidelines, not only because in a meta-analysis of four major randomized trials it resulted in a further 64% reduction in the risk of coronary death or recurrent MI, compared with moderate statin therapy, but also because of the 27% relative risk reduction in new-onset HF. ACE inhibitors get a class IA recommendation for prevention of symptomatic HF in patients who are stage A with a history of atherosclerotic disease, diabetes, or hypertension. Angiotensin receptor blockers get a class IC recommendation.
Diabetes
Diabetes markedly increases the risk of developing HF: by two to four times overall and by four to eight times in younger diabetes patients. The two chronic diseases are highly comorbid, with roughly 45% of patients with HF also having diabetes. Moreover, diabetes in HF patients is associated with a substantially worse prognosis, even when standard HF therapies are applied.
Choices regarding glycemic management can markedly affect HF risk and outcomes. Randomized trials show that the peroxisome proliferator-activated receptor agonists double the risk of HF. The glucagonlike peptide–1 receptor agonists are absolutely neutral with regard to HF outcomes. Similarly, the dipeptidyl peptidase–4 inhibitors have no impact on the risks of major adverse cardiovascular events or HF. Intensive glycemic control has no impact on the risk of new-onset HF. Insulin therapy, too, is neutral on this score.
“Depressingly, even lifestyle modification with weight loss, once you have type 2 diabetes, does not lower the risk,” Dr. Fonarow continued.
In contrast, the sodium-glucose transporter 2 (SGLT2) inhibitors have impressive cardiovascular and renal protective benefits in patients with type 2 diabetes, as demonstrated in a meta-analysis of more than 34,000 participants in the randomized trials of empagliflozin (Jardiance) in EMPA-REG OUTCOME, canagliflozin (Invokana) in CANVAS/CANVAS-R, and dapagliflozin (Farxiga) in DECLARE-TIMI 58. The SGLT2 inhibitors collectively reduced the risk of HF hospitalization by 21% in participants with no baseline history of the disease and by 29% in those with a history of HF. Moreover, the risk of progression of renal disease was reduced by 45% (Lancet. 2019 Jan 5;393[10166]:31-9).
More recently, the landmark DAPA-HF trial established SGLT2 inhibitor therapy as part of standard-of-care, guideline-directed medical therapy for patients with HF with reduced ejection fraction regardless of whether they have comorbid type 2 diabetes (N Engl J Med. 2019 Nov 21;381[21]:1995-2008).
These are remarkable medications, generally very well tolerated, and it’s critical that cardiologists get on board in prescribing them, Dr. Fonarow emphasized. He alerted his colleagues to what he called an “incredibly helpful” review article that provides practical guidance for cardiologists in how to start using the SGLT2 inhibitors (JACC Heart Fail. 2019 Feb;7[2]:169-72).
“It’s pretty straightforward,” according to Dr. Fonarow. “If you’re comfortable enough in using ACE inhibitors, angiotensin receptor blockers, and beta-blockers, I think you’ll find these medications fit similarly when you actually get experience in utilizing them.”
He reported serving as a consultant to 10 pharmaceutical or medical device companies.
SNOWMASS, COLO. – If ever there was a major chronic disease that’s teed up and ready to be stamped into submission through diligent application of preventive medicine, it’s the epidemic of heart failure.
“The best way to treat heart failure is to prevent it in the first place. There will be more than 1 million new cases of heart failure this year, and the vast majority of them could have been prevented,” Gregg C. Fonarow, MD, asserted at the annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.
Using firmly evidence-based, guideline-directed therapies, it’s often possible to prevent patients at high risk for developing heart failure (HF) from actually doing so. Or, in the terminology of the ACC/American Heart Association heart failure guidelines coauthored by Dr. Fonarow, the goal is to keep patients who are stage A – that is, pre-HF but at high risk because of hypertension, coronary artery disease, diabetes, family history of cardiomyopathy, or other reasons – from progressing to stage B, marked by asymptomatic left ventricular dysfunction, a prior MI, or asymptomatic valvular disease; and blocking those who are stage B from then moving on to stage C, the classic symptomatic form of HF; and thence to end-stage stage D disease.
Heart failure is an enormous public health problem, and one of the most expensive of all diseases. The prognostic impact of newly diagnosed HF is profound, with 10-15 years of life lost, compared with the general population. Even today, roughly one in five newly diagnosed patients won’t survive for a year, and the 5-year mortality is about 50%, said Dr. Fonarow, who is professor of cardiovascular medicine and chief of the division of cardiology at the University of California, Los Angeles, and director of the Ahmanson-UCLA Cardiomyopathy Center, also in Los Angeles.
Symptomatic stage C is “the tip of the iceberg,” the cardiologist stressed. Vastly more patients are in stages A and B. In order to keep them from progressing to stage C, it’s first necessary to identify them. That’s why the 2013 guidelines give a class IC recommendation for periodic evaluation for signs and symptoms of HF in patients who are at high risk, and for a noninvasive assessment of left ventricular ejection fraction in those with a strong family history of cardiomyopathy or who are on cardiotoxic drugs (J Am Coll Cardiol. 2013 Oct 15;62[16]:e147-239).
The two biggest risk factors for the development of symptomatic stage C HF are hypertension and atherosclerotic cardiovascular disease. Close to 80% of patients presenting with heart failure have prevalent hypertension, and a history of ischemic heart disease is nearly as common.
Other major modifiable risk factors are diabetes, overweight and obesity, metabolic syndrome, dyslipidemia, smoking, valvular heart disease, and chronic kidney disease.
Hypertension
Most patients with high blood pressure believe they’re on antihypertensive medication to prevent MI and stroke, but in reality the largest benefit is what Dr. Fonarow termed the “phenomenal” reduction in the risk of developing HF, which amounted to a 52% relative risk reduction in one meta-analysis of older randomized trials. In the contemporary era, the landmark SPRINT trial of close to 10,000 randomized hypertensive patients showed that more-intensive blood pressure lowering to a target systolic BP of less than 120 mm Hg resulted in a 38% reduction in the risk of new-onset HF, compared with standard treatment to a target of less than 140 mm Hg. That’s why the 2017 focused update of the HF guidelines gives a strong class IB recommendation for a target blood pressure of less than 130/80 mm Hg in hypertensive patients with stage A HF (J Am Coll Cardiol. 2017 Aug 8;70[6]:776-803).
Atherosclerotic cardiovascular disease
Within 6 years after diagnosis of an MI, 22% of men and 46% of women will develop symptomatic heart failure. Intensive statin therapy gets a strong recommendation post MI in the guidelines, not only because in a meta-analysis of four major randomized trials it resulted in a further 64% reduction in the risk of coronary death or recurrent MI, compared with moderate statin therapy, but also because of the 27% relative risk reduction in new-onset HF. ACE inhibitors get a class IA recommendation for prevention of symptomatic HF in patients who are stage A with a history of atherosclerotic disease, diabetes, or hypertension. Angiotensin receptor blockers get a class IC recommendation.
Diabetes
Diabetes markedly increases the risk of developing HF: by two to four times overall and by four to eight times in younger diabetes patients. The two chronic diseases are highly comorbid, with roughly 45% of patients with HF also having diabetes. Moreover, diabetes in HF patients is associated with a substantially worse prognosis, even when standard HF therapies are applied.
Choices regarding glycemic management can markedly affect HF risk and outcomes. Randomized trials show that the peroxisome proliferator-activated receptor agonists double the risk of HF. The glucagonlike peptide–1 receptor agonists are absolutely neutral with regard to HF outcomes. Similarly, the dipeptidyl peptidase–4 inhibitors have no impact on the risks of major adverse cardiovascular events or HF. Intensive glycemic control has no impact on the risk of new-onset HF. Insulin therapy, too, is neutral on this score.
“Depressingly, even lifestyle modification with weight loss, once you have type 2 diabetes, does not lower the risk,” Dr. Fonarow continued.
In contrast, the sodium-glucose transporter 2 (SGLT2) inhibitors have impressive cardiovascular and renal protective benefits in patients with type 2 diabetes, as demonstrated in a meta-analysis of more than 34,000 participants in the randomized trials of empagliflozin (Jardiance) in EMPA-REG OUTCOME, canagliflozin (Invokana) in CANVAS/CANVAS-R, and dapagliflozin (Farxiga) in DECLARE-TIMI 58. The SGLT2 inhibitors collectively reduced the risk of HF hospitalization by 21% in participants with no baseline history of the disease and by 29% in those with a history of HF. Moreover, the risk of progression of renal disease was reduced by 45% (Lancet. 2019 Jan 5;393[10166]:31-9).
More recently, the landmark DAPA-HF trial established SGLT2 inhibitor therapy as part of standard-of-care, guideline-directed medical therapy for patients with HF with reduced ejection fraction regardless of whether they have comorbid type 2 diabetes (N Engl J Med. 2019 Nov 21;381[21]:1995-2008).
These are remarkable medications, generally very well tolerated, and it’s critical that cardiologists get on board in prescribing them, Dr. Fonarow emphasized. He alerted his colleagues to what he called an “incredibly helpful” review article that provides practical guidance for cardiologists in how to start using the SGLT2 inhibitors (JACC Heart Fail. 2019 Feb;7[2]:169-72).
“It’s pretty straightforward,” according to Dr. Fonarow. “If you’re comfortable enough in using ACE inhibitors, angiotensin receptor blockers, and beta-blockers, I think you’ll find these medications fit similarly when you actually get experience in utilizing them.”
He reported serving as a consultant to 10 pharmaceutical or medical device companies.
EXPERT ANALYSIS FROM ACC SNOWMASS 2020
Myth busting: Sudden cardiac death in athletes
SNOWMASS, COLO. – Myths and misconceptions abound regarding the merits of universal incorporation of the resting 12-lead ECG into preparticipation cardiovascular screening of young athletes, Aaron L. Baggish, MD, declared at the annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.
Dr. Baggish, director of the Cardiovascular Performance Program at Massachusetts General Hospital and a cardiologist at Harvard Medical School, Boston, set out to pop the balloons of a handful of these widely floating myths. These are commonly held fictions: In an electronic poll at the outset of his talk, only one in five members of his large audience recognized all of the following boldface statements as false.
“Preparticipation cardiovascular screening (PPCVS) has been shown to reduce the incidence of sudden cardiac death (SCD) among young competitive athletes.”
FALSE. Not for PPCVS by history and physical examination alone, or with the addition of a screening 12-lead ECG. In Italy, where a cluster of high-profile sudden cardiac deaths led to passage of a 1982 national law mandating 12-lead ECG screening as part of the PPCVS, investigators presented studies purporting to demonstrate a subsequent reduction in the risk of SCD. But those studies were subsequently shown to be fraught with problems. And a high-quality study capable of convincingly demonstrating such a benefit would need to be prohibitively large and expensive. “Don’t hold your breath waiting for that to happen anytime soon,” advised Dr. Baggish, who is medical director for the Boston Marathon, as well as team cardiologist for Harvard University Athletics, the New England Patriots, the Boston Bruins, USRowing, and U.S. Soccer.
“Hypertrophic cardiomyopathy is the leading cause of sudden death among young competitive athletes.”
FALSE. A study of the National Collegiate Athletic Association (NCAA) comprehensive database, with 4.2 million athlete-years of follow-up, showed that the most common cause of SCD was autopsy-negative sudden unexplained death (SUD), accounting for 25% of cases. Hypertrophic cardiomyopathy was deemed the cause of 8% of the SCDs (Circulation. 2015 Jul 7;132[1]:10-9).
“The same thing has been shown in studies done in the United Kingdom and in Australia: . Over the next 10 years, I suspect that one of the most important areas that we’ll be looking into will be this SUD area, perhaps using molecular autopsy to make some headway there,” according to the cardiologist.
SCD is rare. In the NCAA study, the incidence was 1 in 53,703 athlete-years. In sobering contrast, accidents, suicide, and homicide accounted for 50% of all deaths in the collegiate athletes.
“When you think about what’s important in terms of educating young people to be safe, the history and physical exam and 12-lead ECG are nowhere near as important as talking with them about minimizing accident risk and staying away from guns,” Dr. Baggish commented.
“Contemporary ECG interpretation criteria designed specifically for use in young athletes have eliminated the problem of false-positive testing.”
FALSE. The story of adding ECG screening to the PPCVS is one of dramatically improved sensitivity over history and physical exam alone, but always at the cost of reduced specificity. In the Harvard Athlete Initiative Study, Dr. Baggish and coworkers reported that adding the 12-lead ECG resulted in a 17% false-positive rate (Ann Intern Med. 2010 Mar 2;152[5]:269-75). Similar findings were reported in independent studies at two other large universities.
“An ECG false-positive rate of 16%-20%? That’s big trouble. Remember, the conditions we’re looking for are uncommon, with a prevalence of maybe 1 in 500 at most. So if you’re flagging one-fifth or one-sixth of your athletes, the ECG is really not an appropriate tool for screening,” he commented.
Recognition of this limitation has led to development of refined, improved ECG criteria: most notably, the 2012 Seattle criteria, with an associated false-positive rate of 4%-8%, followed by the 2017 International Consensus Criteria (J Am Coll Cardiol. 2017 Feb 28;69[8]:1057-75), with a false-positive rate of 1%-2%. That’s a great improvement. Still, when Dr. Baggish, a marathoner himself, thinks about the roughly 32,000 Boston Marathon runners at the starting line each year, that false-positive rate would translate into 320-640 of those individuals being needlessly subjected to the not-insignificant time and expense of further testing, along with considerable anxiety for the runners and their families, and perhaps even inappropriate disqualification.
“Current ACC/AHA guidelines recommend against the use of the 12-lead ECG during the PPCVS.”
FALSE. Dr. Baggish was a coauthor of the current guidelines, which he described as “an open-door invitation to local decisions, with some important caveats” (Circulation. 2015 Dec 1;132[22]:e267-72).
The guidelines state that the minimum requirement and legal standard for PPCVS of young competitive athletes is a focused history and physical examination, such as the American College of Cardiology/American Heart Association 14-point screen, which consists of 10 elements addressing personal and family history and 4 focused on the physical examination, or the American Academy of Pediatrics Preparticipation Physical Evaluation. Further, while mandatory universal inclusion of the 12-lead ECG is not recommended – it’s rated Class III, meaning don’t do it – the guidelines state that screening programs are at liberty to choose the 12-lead ECG as an additional tool, “provided that close physician involvement and sufficient quality control can be achieved. If undertaken, such initiatives should recognize the known and anticipated limitations of the 12-lead ECG as a population screening test, including the expected frequency of false-positive and false-negative test results, as well as the cost required to support these initiatives over time.”
Dr. Baggish considers the ACC/AHA guidelines to be one of the two most important developments in the field of SCD during sports in recent years. The other is the NCAA-sponsored multidisciplinary Interassociation Consensus Statement on Cardiovascular Care of College Student-Athletes, which he also coauthored (J Am Coll Cardiol. 2016 Jun 28;67[25]:2981-95).
The report lays out the case for a much broader than traditional view of the PPCVS, with “goals that extend beyond detection of occult high-risk pathology.”
“The NCAA has done something very interesting,” Dr. Baggish explained. “It has said that, if we’re going to be screening, we should be thinking about screening with a much broader rationale. It’s not just about finding the needle-in-a-haystack hypertrophic cardiomyopathy or anomalous coronary arteries, it’s about engaging student-athletes at an early point in their collegiate career and trying to improve their health overall – and not just while they’re in college, but over their lifespan.”
He reported having no financial conflicts regarding his presentation.
SNOWMASS, COLO. – Myths and misconceptions abound regarding the merits of universal incorporation of the resting 12-lead ECG into preparticipation cardiovascular screening of young athletes, Aaron L. Baggish, MD, declared at the annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.
Dr. Baggish, director of the Cardiovascular Performance Program at Massachusetts General Hospital and a cardiologist at Harvard Medical School, Boston, set out to pop the balloons of a handful of these widely floating myths. These are commonly held fictions: In an electronic poll at the outset of his talk, only one in five members of his large audience recognized all of the following boldface statements as false.
“Preparticipation cardiovascular screening (PPCVS) has been shown to reduce the incidence of sudden cardiac death (SCD) among young competitive athletes.”
FALSE. Not for PPCVS by history and physical examination alone, or with the addition of a screening 12-lead ECG. In Italy, where a cluster of high-profile sudden cardiac deaths led to passage of a 1982 national law mandating 12-lead ECG screening as part of the PPCVS, investigators presented studies purporting to demonstrate a subsequent reduction in the risk of SCD. But those studies were subsequently shown to be fraught with problems. And a high-quality study capable of convincingly demonstrating such a benefit would need to be prohibitively large and expensive. “Don’t hold your breath waiting for that to happen anytime soon,” advised Dr. Baggish, who is medical director for the Boston Marathon, as well as team cardiologist for Harvard University Athletics, the New England Patriots, the Boston Bruins, USRowing, and U.S. Soccer.
“Hypertrophic cardiomyopathy is the leading cause of sudden death among young competitive athletes.”
FALSE. A study of the National Collegiate Athletic Association (NCAA) comprehensive database, with 4.2 million athlete-years of follow-up, showed that the most common cause of SCD was autopsy-negative sudden unexplained death (SUD), accounting for 25% of cases. Hypertrophic cardiomyopathy was deemed the cause of 8% of the SCDs (Circulation. 2015 Jul 7;132[1]:10-9).
“The same thing has been shown in studies done in the United Kingdom and in Australia: . Over the next 10 years, I suspect that one of the most important areas that we’ll be looking into will be this SUD area, perhaps using molecular autopsy to make some headway there,” according to the cardiologist.
SCD is rare. In the NCAA study, the incidence was 1 in 53,703 athlete-years. In sobering contrast, accidents, suicide, and homicide accounted for 50% of all deaths in the collegiate athletes.
“When you think about what’s important in terms of educating young people to be safe, the history and physical exam and 12-lead ECG are nowhere near as important as talking with them about minimizing accident risk and staying away from guns,” Dr. Baggish commented.
“Contemporary ECG interpretation criteria designed specifically for use in young athletes have eliminated the problem of false-positive testing.”
FALSE. The story of adding ECG screening to the PPCVS is one of dramatically improved sensitivity over history and physical exam alone, but always at the cost of reduced specificity. In the Harvard Athlete Initiative Study, Dr. Baggish and coworkers reported that adding the 12-lead ECG resulted in a 17% false-positive rate (Ann Intern Med. 2010 Mar 2;152[5]:269-75). Similar findings were reported in independent studies at two other large universities.
“An ECG false-positive rate of 16%-20%? That’s big trouble. Remember, the conditions we’re looking for are uncommon, with a prevalence of maybe 1 in 500 at most. So if you’re flagging one-fifth or one-sixth of your athletes, the ECG is really not an appropriate tool for screening,” he commented.
Recognition of this limitation has led to development of refined, improved ECG criteria: most notably, the 2012 Seattle criteria, with an associated false-positive rate of 4%-8%, followed by the 2017 International Consensus Criteria (J Am Coll Cardiol. 2017 Feb 28;69[8]:1057-75), with a false-positive rate of 1%-2%. That’s a great improvement. Still, when Dr. Baggish, a marathoner himself, thinks about the roughly 32,000 Boston Marathon runners at the starting line each year, that false-positive rate would translate into 320-640 of those individuals being needlessly subjected to the not-insignificant time and expense of further testing, along with considerable anxiety for the runners and their families, and perhaps even inappropriate disqualification.
“Current ACC/AHA guidelines recommend against the use of the 12-lead ECG during the PPCVS.”
FALSE. Dr. Baggish was a coauthor of the current guidelines, which he described as “an open-door invitation to local decisions, with some important caveats” (Circulation. 2015 Dec 1;132[22]:e267-72).
The guidelines state that the minimum requirement and legal standard for PPCVS of young competitive athletes is a focused history and physical examination, such as the American College of Cardiology/American Heart Association 14-point screen, which consists of 10 elements addressing personal and family history and 4 focused on the physical examination, or the American Academy of Pediatrics Preparticipation Physical Evaluation. Further, while mandatory universal inclusion of the 12-lead ECG is not recommended – it’s rated Class III, meaning don’t do it – the guidelines state that screening programs are at liberty to choose the 12-lead ECG as an additional tool, “provided that close physician involvement and sufficient quality control can be achieved. If undertaken, such initiatives should recognize the known and anticipated limitations of the 12-lead ECG as a population screening test, including the expected frequency of false-positive and false-negative test results, as well as the cost required to support these initiatives over time.”
Dr. Baggish considers the ACC/AHA guidelines to be one of the two most important developments in the field of SCD during sports in recent years. The other is the NCAA-sponsored multidisciplinary Interassociation Consensus Statement on Cardiovascular Care of College Student-Athletes, which he also coauthored (J Am Coll Cardiol. 2016 Jun 28;67[25]:2981-95).
The report lays out the case for a much broader than traditional view of the PPCVS, with “goals that extend beyond detection of occult high-risk pathology.”
“The NCAA has done something very interesting,” Dr. Baggish explained. “It has said that, if we’re going to be screening, we should be thinking about screening with a much broader rationale. It’s not just about finding the needle-in-a-haystack hypertrophic cardiomyopathy or anomalous coronary arteries, it’s about engaging student-athletes at an early point in their collegiate career and trying to improve their health overall – and not just while they’re in college, but over their lifespan.”
He reported having no financial conflicts regarding his presentation.
SNOWMASS, COLO. – Myths and misconceptions abound regarding the merits of universal incorporation of the resting 12-lead ECG into preparticipation cardiovascular screening of young athletes, Aaron L. Baggish, MD, declared at the annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.
Dr. Baggish, director of the Cardiovascular Performance Program at Massachusetts General Hospital and a cardiologist at Harvard Medical School, Boston, set out to pop the balloons of a handful of these widely floating myths. These are commonly held fictions: In an electronic poll at the outset of his talk, only one in five members of his large audience recognized all of the following boldface statements as false.
“Preparticipation cardiovascular screening (PPCVS) has been shown to reduce the incidence of sudden cardiac death (SCD) among young competitive athletes.”
FALSE. Not for PPCVS by history and physical examination alone, or with the addition of a screening 12-lead ECG. In Italy, where a cluster of high-profile sudden cardiac deaths led to passage of a 1982 national law mandating 12-lead ECG screening as part of the PPCVS, investigators presented studies purporting to demonstrate a subsequent reduction in the risk of SCD. But those studies were subsequently shown to be fraught with problems. And a high-quality study capable of convincingly demonstrating such a benefit would need to be prohibitively large and expensive. “Don’t hold your breath waiting for that to happen anytime soon,” advised Dr. Baggish, who is medical director for the Boston Marathon, as well as team cardiologist for Harvard University Athletics, the New England Patriots, the Boston Bruins, USRowing, and U.S. Soccer.
“Hypertrophic cardiomyopathy is the leading cause of sudden death among young competitive athletes.”
FALSE. A study of the National Collegiate Athletic Association (NCAA) comprehensive database, with 4.2 million athlete-years of follow-up, showed that the most common cause of SCD was autopsy-negative sudden unexplained death (SUD), accounting for 25% of cases. Hypertrophic cardiomyopathy was deemed the cause of 8% of the SCDs (Circulation. 2015 Jul 7;132[1]:10-9).
“The same thing has been shown in studies done in the United Kingdom and in Australia: . Over the next 10 years, I suspect that one of the most important areas that we’ll be looking into will be this SUD area, perhaps using molecular autopsy to make some headway there,” according to the cardiologist.
SCD is rare. In the NCAA study, the incidence was 1 in 53,703 athlete-years. In sobering contrast, accidents, suicide, and homicide accounted for 50% of all deaths in the collegiate athletes.
“When you think about what’s important in terms of educating young people to be safe, the history and physical exam and 12-lead ECG are nowhere near as important as talking with them about minimizing accident risk and staying away from guns,” Dr. Baggish commented.
“Contemporary ECG interpretation criteria designed specifically for use in young athletes have eliminated the problem of false-positive testing.”
FALSE. The story of adding ECG screening to the PPCVS is one of dramatically improved sensitivity over history and physical exam alone, but always at the cost of reduced specificity. In the Harvard Athlete Initiative Study, Dr. Baggish and coworkers reported that adding the 12-lead ECG resulted in a 17% false-positive rate (Ann Intern Med. 2010 Mar 2;152[5]:269-75). Similar findings were reported in independent studies at two other large universities.
“An ECG false-positive rate of 16%-20%? That’s big trouble. Remember, the conditions we’re looking for are uncommon, with a prevalence of maybe 1 in 500 at most. So if you’re flagging one-fifth or one-sixth of your athletes, the ECG is really not an appropriate tool for screening,” he commented.
Recognition of this limitation has led to development of refined, improved ECG criteria: most notably, the 2012 Seattle criteria, with an associated false-positive rate of 4%-8%, followed by the 2017 International Consensus Criteria (J Am Coll Cardiol. 2017 Feb 28;69[8]:1057-75), with a false-positive rate of 1%-2%. That’s a great improvement. Still, when Dr. Baggish, a marathoner himself, thinks about the roughly 32,000 Boston Marathon runners at the starting line each year, that false-positive rate would translate into 320-640 of those individuals being needlessly subjected to the not-insignificant time and expense of further testing, along with considerable anxiety for the runners and their families, and perhaps even inappropriate disqualification.
“Current ACC/AHA guidelines recommend against the use of the 12-lead ECG during the PPCVS.”
FALSE. Dr. Baggish was a coauthor of the current guidelines, which he described as “an open-door invitation to local decisions, with some important caveats” (Circulation. 2015 Dec 1;132[22]:e267-72).
The guidelines state that the minimum requirement and legal standard for PPCVS of young competitive athletes is a focused history and physical examination, such as the American College of Cardiology/American Heart Association 14-point screen, which consists of 10 elements addressing personal and family history and 4 focused on the physical examination, or the American Academy of Pediatrics Preparticipation Physical Evaluation. Further, while mandatory universal inclusion of the 12-lead ECG is not recommended – it’s rated Class III, meaning don’t do it – the guidelines state that screening programs are at liberty to choose the 12-lead ECG as an additional tool, “provided that close physician involvement and sufficient quality control can be achieved. If undertaken, such initiatives should recognize the known and anticipated limitations of the 12-lead ECG as a population screening test, including the expected frequency of false-positive and false-negative test results, as well as the cost required to support these initiatives over time.”
Dr. Baggish considers the ACC/AHA guidelines to be one of the two most important developments in the field of SCD during sports in recent years. The other is the NCAA-sponsored multidisciplinary Interassociation Consensus Statement on Cardiovascular Care of College Student-Athletes, which he also coauthored (J Am Coll Cardiol. 2016 Jun 28;67[25]:2981-95).
The report lays out the case for a much broader than traditional view of the PPCVS, with “goals that extend beyond detection of occult high-risk pathology.”
“The NCAA has done something very interesting,” Dr. Baggish explained. “It has said that, if we’re going to be screening, we should be thinking about screening with a much broader rationale. It’s not just about finding the needle-in-a-haystack hypertrophic cardiomyopathy or anomalous coronary arteries, it’s about engaging student-athletes at an early point in their collegiate career and trying to improve their health overall – and not just while they’re in college, but over their lifespan.”
He reported having no financial conflicts regarding his presentation.
REPORTING FROM ACC SNOWMASS 2020
Cardiac arrest: Targeted temperature management a game changer
SNOWMASS, COLO. – Targeted temperature management maintained at 32-36 degrees Celsius is now a strong class I recommendation for all comatose patients who experience return of spontaneous circulation after out-of-hospital cardiac arrest, including those with nonshockable rhythms, Erin A. Bohula, MD, PhD, said at the annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.
“Our practice is that ,” said Dr. Bohula, a cardiologist and critical care specialist at Brigham and Women’s Hospital and Harvard Medical School, Boston.
The current ACC/AHA guidelines declare: “There are essentially no patients for whom temperature control somewhere in the range between 32 degrees C [89.6 F) and 36 degrees C [96.8 F] is contraindicated.” The writing committee cited “recent clinical trial data enrolling patients with all rhythms, the rarity of adverse effects in trials, the high neurologic morbidity and mortality without any specific interventions, and the preponderance of data suggesting that temperature is an important variable for neurologic recovery” (Circulation. 2015 Nov 3;132[18 Suppl 2]:S465-82).
“That’s a pretty strong statement,” Dr. Bohula observed.
The current guidelines, which date back to 2015, give a class I, level of evidence B recommendation for targeted temperature management (TTM) in patients who are comatose with return of spontaneous circulation (ROSC) after out-of-hospital cardiac arrest involving ventricular fibrillation or pulseless ventricular fibrillation. The bedside definition of comatose is lack of meaningful response to verbal commands to squeeze hands, blink, or move toes.
The current recommendation for TTM in patients resuscitated from out-of-hospital cardiac arrest with a nonshockable rhythm is class I, level of evidence C, meaning it’s based on expert consensus. However, that recommendation is now out of date and due for a level-of-evidence upgrade in light of the recent results of the French HYPERION trial, an open-label randomized trial of 584 patients resuscitated from cardiac arrest with a nonshockable rhythm. Although 90-day mortality was similarly high in the TTM and targeted normothermia groups, the rate of favorable neurologic outcome as assessed by a Cerebral Performance Category scale score of 1 or 2 was 10.2% in the TTM group, significantly better than the 5.7% rate in controls (N Engl J Med. 2019 Dec 12;381[24]:2327-37).
The 2010, ACC/AHA guidelines recommended a TTM range of 32-34 degrees C, but on the basis of subsequent persuasive randomized trial data, that range was broadened to 32-36 degrees C in the 2015 guidelines, with a class IB recommendation. Maintenance of TTM for at least 24 hours has a IIa, level of evidence C recommendation in the current guidelines.
The guidelines emphasize that specific features may favor selection of one temperature for TTM over another. For example, patients with seizures or cerebral edema might be better off with TTM at a lower temperature, while a higher temperature may be best for those with bleeding or severe bradycardia. At Brigham and Women’s Hospital, the default temperature is 33 degrees C. However, TTM with a goal of 36 degrees C is seriously considered in patients with recent head trauma, major surgery within the past 2 weeks, refractory hypotension, severe sepsis, pregnancy, or high bleeding risk. Rewarming is done at a rate of 0.25 degrees C per hour, with sedation maintained until the patient has been returned to 98.6 degrees F, according to Dr. Bohula.
Based on several negative studies of TTM using rapid infusion of chilled fluids in the ambulance en route to the hospital, the guidelines rate that practice class IIIA, meaning don’t do it. Avoidance of a systolic blood pressure below 90 mm Hg and a mean arterial pressure of less than 65 mm Hg gets a class IIb level of evidence C recommendation to lessen the risk of cerebral hypoxia.
TTM a major breakthrough
Prior to the introduction of TTM, comatose patients with ROSC after out-of-hospital cardiac arrest had a dreadful prognosis, with survival rates of 1%-10% in registry studies. In contrast, the survival rate in the landmark TTM clinical trials was 50%-60%. And while that’s a dramatic improvement, ROSC after cardiac arrest remains a high-mortality condition. Dr. Bohula was first author of a report by the Critical Care Cardiology Trials Network, composed of 16 tertiary cardiac intensive care units in the United States and Canada. Cardiac arrest was the primary indication for 8.7% of 3,049 consecutive admissions, and its 38% mortality rate was the highest of all cardiac critical care indications (JAMA Cardiol. 2019 Jul 24;4[9]:928-35).
TTM was developed in response to a recognition that two-thirds of deaths in patients who make it to the hospital after out-of-hospital cardiac arrest are neurologic – the result of brain anoxia – rather than being due to the myocardial ischemia that may have initially brought them to medical attention.
“Time is brain cells, the same way we think of time as cardiac muscle,” Dr. Bohula observed.
The main idea behind therapeutic hypothermia is that it lowers the cerebral metabolic rate of oxygen to reduce the consequences of ongoing anoxia. The brain doesn’t require as much perfusion when cooled.
TTM has other beneficial neurologic effects as well: It reduces cerebral blood volume via autoregulation, decreases intracranial pressure, and blunts the inflammatory response involved in the postcardiac arrest syndrome. In addition, TTM has anticonvulsant properties, an important effect because seizures and/or myoclonus occur in up to 15% of adults who achieve ROSC after cardiac arrest – and in even more of those who are comatose after doing so. And seizures increase the brain’s metabolic rate threefold, resulting in more cerebral ischemic injury, she explained.
Seizure activity can be difficult to distinguish from shivering in a patient on TTM. For this reason Dr. Bohula recommends putting patients on continuous EEG monitoring from the time of admission, as is the routine practice at the Brigham.
She reported serving as a consultant to Daiichi Sankyo, Servier, Lexicon, Kowa, Merck, Novartis, Novo Nordisk, and the National Institutes of Health. In addition, she generates institutional research grants provided by a half-dozen pharmaceutical companies.
SNOWMASS, COLO. – Targeted temperature management maintained at 32-36 degrees Celsius is now a strong class I recommendation for all comatose patients who experience return of spontaneous circulation after out-of-hospital cardiac arrest, including those with nonshockable rhythms, Erin A. Bohula, MD, PhD, said at the annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.
“Our practice is that ,” said Dr. Bohula, a cardiologist and critical care specialist at Brigham and Women’s Hospital and Harvard Medical School, Boston.
The current ACC/AHA guidelines declare: “There are essentially no patients for whom temperature control somewhere in the range between 32 degrees C [89.6 F) and 36 degrees C [96.8 F] is contraindicated.” The writing committee cited “recent clinical trial data enrolling patients with all rhythms, the rarity of adverse effects in trials, the high neurologic morbidity and mortality without any specific interventions, and the preponderance of data suggesting that temperature is an important variable for neurologic recovery” (Circulation. 2015 Nov 3;132[18 Suppl 2]:S465-82).
“That’s a pretty strong statement,” Dr. Bohula observed.
The current guidelines, which date back to 2015, give a class I, level of evidence B recommendation for targeted temperature management (TTM) in patients who are comatose with return of spontaneous circulation (ROSC) after out-of-hospital cardiac arrest involving ventricular fibrillation or pulseless ventricular fibrillation. The bedside definition of comatose is lack of meaningful response to verbal commands to squeeze hands, blink, or move toes.
The current recommendation for TTM in patients resuscitated from out-of-hospital cardiac arrest with a nonshockable rhythm is class I, level of evidence C, meaning it’s based on expert consensus. However, that recommendation is now out of date and due for a level-of-evidence upgrade in light of the recent results of the French HYPERION trial, an open-label randomized trial of 584 patients resuscitated from cardiac arrest with a nonshockable rhythm. Although 90-day mortality was similarly high in the TTM and targeted normothermia groups, the rate of favorable neurologic outcome as assessed by a Cerebral Performance Category scale score of 1 or 2 was 10.2% in the TTM group, significantly better than the 5.7% rate in controls (N Engl J Med. 2019 Dec 12;381[24]:2327-37).
The 2010, ACC/AHA guidelines recommended a TTM range of 32-34 degrees C, but on the basis of subsequent persuasive randomized trial data, that range was broadened to 32-36 degrees C in the 2015 guidelines, with a class IB recommendation. Maintenance of TTM for at least 24 hours has a IIa, level of evidence C recommendation in the current guidelines.
The guidelines emphasize that specific features may favor selection of one temperature for TTM over another. For example, patients with seizures or cerebral edema might be better off with TTM at a lower temperature, while a higher temperature may be best for those with bleeding or severe bradycardia. At Brigham and Women’s Hospital, the default temperature is 33 degrees C. However, TTM with a goal of 36 degrees C is seriously considered in patients with recent head trauma, major surgery within the past 2 weeks, refractory hypotension, severe sepsis, pregnancy, or high bleeding risk. Rewarming is done at a rate of 0.25 degrees C per hour, with sedation maintained until the patient has been returned to 98.6 degrees F, according to Dr. Bohula.
Based on several negative studies of TTM using rapid infusion of chilled fluids in the ambulance en route to the hospital, the guidelines rate that practice class IIIA, meaning don’t do it. Avoidance of a systolic blood pressure below 90 mm Hg and a mean arterial pressure of less than 65 mm Hg gets a class IIb level of evidence C recommendation to lessen the risk of cerebral hypoxia.
TTM a major breakthrough
Prior to the introduction of TTM, comatose patients with ROSC after out-of-hospital cardiac arrest had a dreadful prognosis, with survival rates of 1%-10% in registry studies. In contrast, the survival rate in the landmark TTM clinical trials was 50%-60%. And while that’s a dramatic improvement, ROSC after cardiac arrest remains a high-mortality condition. Dr. Bohula was first author of a report by the Critical Care Cardiology Trials Network, composed of 16 tertiary cardiac intensive care units in the United States and Canada. Cardiac arrest was the primary indication for 8.7% of 3,049 consecutive admissions, and its 38% mortality rate was the highest of all cardiac critical care indications (JAMA Cardiol. 2019 Jul 24;4[9]:928-35).
TTM was developed in response to a recognition that two-thirds of deaths in patients who make it to the hospital after out-of-hospital cardiac arrest are neurologic – the result of brain anoxia – rather than being due to the myocardial ischemia that may have initially brought them to medical attention.
“Time is brain cells, the same way we think of time as cardiac muscle,” Dr. Bohula observed.
The main idea behind therapeutic hypothermia is that it lowers the cerebral metabolic rate of oxygen to reduce the consequences of ongoing anoxia. The brain doesn’t require as much perfusion when cooled.
TTM has other beneficial neurologic effects as well: It reduces cerebral blood volume via autoregulation, decreases intracranial pressure, and blunts the inflammatory response involved in the postcardiac arrest syndrome. In addition, TTM has anticonvulsant properties, an important effect because seizures and/or myoclonus occur in up to 15% of adults who achieve ROSC after cardiac arrest – and in even more of those who are comatose after doing so. And seizures increase the brain’s metabolic rate threefold, resulting in more cerebral ischemic injury, she explained.
Seizure activity can be difficult to distinguish from shivering in a patient on TTM. For this reason Dr. Bohula recommends putting patients on continuous EEG monitoring from the time of admission, as is the routine practice at the Brigham.
She reported serving as a consultant to Daiichi Sankyo, Servier, Lexicon, Kowa, Merck, Novartis, Novo Nordisk, and the National Institutes of Health. In addition, she generates institutional research grants provided by a half-dozen pharmaceutical companies.
SNOWMASS, COLO. – Targeted temperature management maintained at 32-36 degrees Celsius is now a strong class I recommendation for all comatose patients who experience return of spontaneous circulation after out-of-hospital cardiac arrest, including those with nonshockable rhythms, Erin A. Bohula, MD, PhD, said at the annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.
“Our practice is that ,” said Dr. Bohula, a cardiologist and critical care specialist at Brigham and Women’s Hospital and Harvard Medical School, Boston.
The current ACC/AHA guidelines declare: “There are essentially no patients for whom temperature control somewhere in the range between 32 degrees C [89.6 F) and 36 degrees C [96.8 F] is contraindicated.” The writing committee cited “recent clinical trial data enrolling patients with all rhythms, the rarity of adverse effects in trials, the high neurologic morbidity and mortality without any specific interventions, and the preponderance of data suggesting that temperature is an important variable for neurologic recovery” (Circulation. 2015 Nov 3;132[18 Suppl 2]:S465-82).
“That’s a pretty strong statement,” Dr. Bohula observed.
The current guidelines, which date back to 2015, give a class I, level of evidence B recommendation for targeted temperature management (TTM) in patients who are comatose with return of spontaneous circulation (ROSC) after out-of-hospital cardiac arrest involving ventricular fibrillation or pulseless ventricular fibrillation. The bedside definition of comatose is lack of meaningful response to verbal commands to squeeze hands, blink, or move toes.
The current recommendation for TTM in patients resuscitated from out-of-hospital cardiac arrest with a nonshockable rhythm is class I, level of evidence C, meaning it’s based on expert consensus. However, that recommendation is now out of date and due for a level-of-evidence upgrade in light of the recent results of the French HYPERION trial, an open-label randomized trial of 584 patients resuscitated from cardiac arrest with a nonshockable rhythm. Although 90-day mortality was similarly high in the TTM and targeted normothermia groups, the rate of favorable neurologic outcome as assessed by a Cerebral Performance Category scale score of 1 or 2 was 10.2% in the TTM group, significantly better than the 5.7% rate in controls (N Engl J Med. 2019 Dec 12;381[24]:2327-37).
The 2010, ACC/AHA guidelines recommended a TTM range of 32-34 degrees C, but on the basis of subsequent persuasive randomized trial data, that range was broadened to 32-36 degrees C in the 2015 guidelines, with a class IB recommendation. Maintenance of TTM for at least 24 hours has a IIa, level of evidence C recommendation in the current guidelines.
The guidelines emphasize that specific features may favor selection of one temperature for TTM over another. For example, patients with seizures or cerebral edema might be better off with TTM at a lower temperature, while a higher temperature may be best for those with bleeding or severe bradycardia. At Brigham and Women’s Hospital, the default temperature is 33 degrees C. However, TTM with a goal of 36 degrees C is seriously considered in patients with recent head trauma, major surgery within the past 2 weeks, refractory hypotension, severe sepsis, pregnancy, or high bleeding risk. Rewarming is done at a rate of 0.25 degrees C per hour, with sedation maintained until the patient has been returned to 98.6 degrees F, according to Dr. Bohula.
Based on several negative studies of TTM using rapid infusion of chilled fluids in the ambulance en route to the hospital, the guidelines rate that practice class IIIA, meaning don’t do it. Avoidance of a systolic blood pressure below 90 mm Hg and a mean arterial pressure of less than 65 mm Hg gets a class IIb level of evidence C recommendation to lessen the risk of cerebral hypoxia.
TTM a major breakthrough
Prior to the introduction of TTM, comatose patients with ROSC after out-of-hospital cardiac arrest had a dreadful prognosis, with survival rates of 1%-10% in registry studies. In contrast, the survival rate in the landmark TTM clinical trials was 50%-60%. And while that’s a dramatic improvement, ROSC after cardiac arrest remains a high-mortality condition. Dr. Bohula was first author of a report by the Critical Care Cardiology Trials Network, composed of 16 tertiary cardiac intensive care units in the United States and Canada. Cardiac arrest was the primary indication for 8.7% of 3,049 consecutive admissions, and its 38% mortality rate was the highest of all cardiac critical care indications (JAMA Cardiol. 2019 Jul 24;4[9]:928-35).
TTM was developed in response to a recognition that two-thirds of deaths in patients who make it to the hospital after out-of-hospital cardiac arrest are neurologic – the result of brain anoxia – rather than being due to the myocardial ischemia that may have initially brought them to medical attention.
“Time is brain cells, the same way we think of time as cardiac muscle,” Dr. Bohula observed.
The main idea behind therapeutic hypothermia is that it lowers the cerebral metabolic rate of oxygen to reduce the consequences of ongoing anoxia. The brain doesn’t require as much perfusion when cooled.
TTM has other beneficial neurologic effects as well: It reduces cerebral blood volume via autoregulation, decreases intracranial pressure, and blunts the inflammatory response involved in the postcardiac arrest syndrome. In addition, TTM has anticonvulsant properties, an important effect because seizures and/or myoclonus occur in up to 15% of adults who achieve ROSC after cardiac arrest – and in even more of those who are comatose after doing so. And seizures increase the brain’s metabolic rate threefold, resulting in more cerebral ischemic injury, she explained.
Seizure activity can be difficult to distinguish from shivering in a patient on TTM. For this reason Dr. Bohula recommends putting patients on continuous EEG monitoring from the time of admission, as is the routine practice at the Brigham.
She reported serving as a consultant to Daiichi Sankyo, Servier, Lexicon, Kowa, Merck, Novartis, Novo Nordisk, and the National Institutes of Health. In addition, she generates institutional research grants provided by a half-dozen pharmaceutical companies.
EXPERT ANALYSIS FROM ACC SNOWMASS 2020
How much exercise is needed for maximum heart benefit?
SNOWMASS, COLO. – Physical activity is potent medicine, and it doesn’t take all that much of it to derive the maximum cardiovascular benefit: namely, the equivalent of a brisk hour-long walk 5 days/week or jogging at a 10-minute-per-mile pace for half an hour twice weekly, Robert A. Vogel, MD, asserted at the annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.
“I’m not telling you to run marathons. said Dr. Vogel, a cardiologist at the University of Colorado at Denver, Aurora, with a longstanding interest in preventive cardiology.
He presented selected highlights from the massive evidence base underlying the recommendations put forth in the current comprehensive U.S. Department of Health & Human Services Physical Activity Guidelines for Americans.
One particularly compelling chunk of evidence comes from a Taiwanese government–funded prospective cohort study of more than 416,000 individuals followed for an average of 8 years. A key finding: 15 minutes of moderate-intensity physical activity daily was associated with a 14% reduction in the relative risk of all-cause mortality and a 19% reduction in death caused by cardiovascular disease, compared with that of inactive individuals. Moreover, each additional 15 minutes of daily moderate exercise further reduced mortality by 4%. These benefits extended across the full age spectrum of both sexes and applied to patients with cardiovascular disease (Lancet. 2011 Oct 1;378[9798]:1244-53).
“That’s a very impressive result for modest physical activity,” the cardiologist commented.
Data on more than 50,000 adult participants in the Aerobics Center Longitudinal Study based at the Cooper Clinic in Dallas show that vigorous exercise in the form of running at 6 mph for half an hour twice weekly, or a total of 10 metabolic equivalent of task hours (MET-HR) per week, was associated with a roughly 40% reduction in cardiovascular disease mortality. Importantly, 20, 40, or 50 MET-HR/week of vigorous exercise conferred no further survival benefit (J Am Coll Cardiol. 2014 Aug 5;64[5]:472-81). The same group showed that the sweet spot for moderate physical activity in terms of reduced cardiovascular mortality was brisk walking for an hour daily 5 days/week, for a total of 20 MET-HR, which was also associated with roughly a 40% risk reduction compared to inactivity. At that point the benefit plateaued, with no further mortality reduction noted with additional MET-HR of moderate exercise.
“For more than that, we have no evidence of additional cardiovascular benefit. It’s not going to get you to the Tokyo Olympics, but that’s what we need to be doing,” Dr. Vogel observed.
In another report from the Aerobics Center Longitudinal Study, investigators found that moderate-level cardiorespiratory fitness as defined by METs was associated with a 44% reduction in the risk of sudden cardiac death in men and women after adjustment for potential confounders, while high-level cardiorespiratory fitness was associated with a closely similar 48% reduction in risk. This applied to individuals who were hypertensive, overweight, and/or had poor health status, as well as to others (Mayo Clin Proc. 2016 Jul;91[7]:849-57).
All activity counts
Exercise physiologists speak of NEPA – nonexercise physical activity – such as taking out the garbage. Swedish investigators followed more than 4,200 individuals for an average of 12.5 years and found that high NEPA activity was independently associated with a 30% reduction in all-cause mortality and a 27% lower risk of a first cardiovascular disease event, compared with low NEPA. High NEPA in regular exercisers was associated with a lower rate of metabolic syndrome than in low-NEPA regular exercisers (Br J Sports Med. 2014 Feb;48[3]:233-8).
Don’t just sit there – stand!
The current federal physical activity guidelines place a new emphasis on the detrimental effects of sitting. A report on more than 221,000 participants in the Australian 45 and Up Study, with close to 1 million person-years of follow-up, demonstrated a linear inverse relationship between standing time per day and all-cause mortality. In a multivariate analysis adjusted for potential confounders, individuals who stood for 2-5 hours per day had a 10% lower risk of all-cause mortality than did those who stood for less than 2 hours. Standing for 5-8 hours was associated with a 15% relative risk reduction. And standing for more than 8 hours daily was linked to a 24% reduction in risk (Prev Med. 2014 Dec;69:187-91).
And it’s not just total daily sitting time that’s a risk factor. Prolonged, uninterrupted sedentary time was also associated with a dose-dependent increase in all-cause mortality in a prospective cohort study of nearly 8,000 U.S. adults (Ann Intern Med. 2017 Oct 3;167[7]:465-75).
“If you can’t walk around, talk to your patients standing up. That activity of getting out of your chair is lifesaving,” the cardiologist advised.
Get strong
Muscle-strengthening activity on at least 2 days/week is recommended in the federal guidelines because it’s independently associated with decreased all-cause mortality, even in individuals getting sufficient aerobic exercise, as shown in a large national study with 15-years’ follow-up (Prev Med. 2016 Jun;87:121-127).
“As we get older, we tend to forget about muscle. I work with the National Football League. These folks are pretty strong, but we never see diabetes in these very big players, who are often well over 300 lb. They’ve got a lot of muscle. If you want to prevent diabetes, be strong. It’s a very important factor,” Dr. Vogel said.
For the time constrained
Jogging is more time-efficient than brisk walking as a way to attain the maximum cardiovascular benefit of exercise. And the so-called “Weekend Warrior” study of nearly 64,000 U.K. adults showed that it’s okay to cram the full week’s worth of exercise into one or two sessions and be done with it. Compared with the inactive study participants, the weekend warriors had a 40% reduction in cardiovascular disease mortality, while individuals who split their physical activity up into three or more sessions per week had a nearly identical 41% relative risk reduction (JAMA Intern Med. 2017 Mar 1;177[3]:335-42).
Interval training is a standard way for athletes in training to improve their endurance by alternating short, intense exercise with brief recovery periods. It’s also a time saver: In one classic bicycling study, physically active men were randomized to standardized 2-week programs of sprint interval training or high-volume endurance training on the bike. The training time required to pass a rigorous cycling time trial test was 90% lower in the interval training group (J Physiol. 2006 Sep 15;575(Pt 3):901-11).
The same principle is applicable to the nonathlete interested in physical activity for heart health.
“When I run a couple of miles, I walk for 5 minutes, then maybe run for three-quarters of a mile, then walk again, then run. In interval training you get your heart rate up, and you drop it down. It’s a very good form of exercise. As a vascular biologist I know that if you put endothelial cells in a Petri dish and spin them real fast continuously, you will not get as good an improvement in endothelial function as if you spin the dish, stop it, spin it, stop it,” Dr. Vogel said.
High-volume exercise is safe, even with high coronary calcium
A clinically significant coronary artery calcification score of 100 Agatston units or more is no reason not to exercise. A Cooper Clinic report on nearly 22,000 middle-aged men without baseline cardiovascular disease who were followed for a mean of 10.4 years concluded that those in the highest-volume exercise group, many of whom were marathon runners and engaged in the equivalent of running for at least 5-6 hours/week at a pace of 10 minutes per mile, were 11% more likely to have an elevated baseline coronary artery calcification score than those who exercised less. But these highest-volume exercisers with elevated coronary calcium – their mean level was 807 Agatston units – had risks of all-cause and cardiovascular mortality that weren’t significantly different from those of men with elevated coronary calcium who exercised more moderately (JAMA Cardiol. 2019 Feb 1;4[2]:174-81).
Cardiac rehab
Dr. Vogel had harsh words for his physician colleagues with respect to the widespread underprescribing of cardiac rehabilitation programs.
“You guys are doing a crappy job with exercise in our most vulnerable patients: those who’ve had cardiovascular events,” he charged. “Cardiac rehabilitation is a Class I recommendation in our guidelines. And yet utilization in the United States is just 10%-20%. No other Class I recommendation is in that ballpark.”
A meta-analysis of 34 randomized trials totaling more than 6,000 post-MI patients concluded that those randomized to exercise-based cardiac rehabilitation had a 47% reduction in the risk of reinfarction, 36% lower cardiac mortality, and a 26% reduction in all-cause mortality (Am Heart J. 2011 Oct;162[4]:571-584.e2).
“The data show that cardiac rehabilitation is as effective as anything else we do in cardiovascular medicine. I understand that patients live far away, they don’t like to exercise – I’ve heard every excuse. But I am charging you with the responsibility of meeting a Class I recommendation that gets patients to live longer,” he declared.
Medicare now covers an enhanced, 72-session program called Intensive Cardiac Rehabilitation that teaches comprehensive lifestyle change and provides reasonable reimbursement. “It’s a good thing for our patients,” Dr. Vogel commented.
Yoga
For patients who are reluctant to pound the pavement, yoga may provide an alternative form of physical activity with tangible cardiovascular benefits. Dr. Vogel pointed to the Yoga-CaRe trial presented at the 2018 scientific sessions of the American Heart Association. Yoga-CaRe randomized 3,959 post-MI patients at 29 centers in India to a program of 13 supervised in-hospital yoga classes followed by yoga at home, or to a control group with three educational sessions. The rate of major adverse cardiovascular events over 42 months of follow-up was cut in half, compared with controls, in the 27% of participants who attended at least 10 of the 13 yoga classes. Their quality of life scores were higher, too.
Dr. Vogel reported serving as a paid consultant to the National Football League and the Pritikin Longevity Center. He is on the speaker’s bureau for Sanofi and Regeneron.
SNOWMASS, COLO. – Physical activity is potent medicine, and it doesn’t take all that much of it to derive the maximum cardiovascular benefit: namely, the equivalent of a brisk hour-long walk 5 days/week or jogging at a 10-minute-per-mile pace for half an hour twice weekly, Robert A. Vogel, MD, asserted at the annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.
“I’m not telling you to run marathons. said Dr. Vogel, a cardiologist at the University of Colorado at Denver, Aurora, with a longstanding interest in preventive cardiology.
He presented selected highlights from the massive evidence base underlying the recommendations put forth in the current comprehensive U.S. Department of Health & Human Services Physical Activity Guidelines for Americans.
One particularly compelling chunk of evidence comes from a Taiwanese government–funded prospective cohort study of more than 416,000 individuals followed for an average of 8 years. A key finding: 15 minutes of moderate-intensity physical activity daily was associated with a 14% reduction in the relative risk of all-cause mortality and a 19% reduction in death caused by cardiovascular disease, compared with that of inactive individuals. Moreover, each additional 15 minutes of daily moderate exercise further reduced mortality by 4%. These benefits extended across the full age spectrum of both sexes and applied to patients with cardiovascular disease (Lancet. 2011 Oct 1;378[9798]:1244-53).
“That’s a very impressive result for modest physical activity,” the cardiologist commented.
Data on more than 50,000 adult participants in the Aerobics Center Longitudinal Study based at the Cooper Clinic in Dallas show that vigorous exercise in the form of running at 6 mph for half an hour twice weekly, or a total of 10 metabolic equivalent of task hours (MET-HR) per week, was associated with a roughly 40% reduction in cardiovascular disease mortality. Importantly, 20, 40, or 50 MET-HR/week of vigorous exercise conferred no further survival benefit (J Am Coll Cardiol. 2014 Aug 5;64[5]:472-81). The same group showed that the sweet spot for moderate physical activity in terms of reduced cardiovascular mortality was brisk walking for an hour daily 5 days/week, for a total of 20 MET-HR, which was also associated with roughly a 40% risk reduction compared to inactivity. At that point the benefit plateaued, with no further mortality reduction noted with additional MET-HR of moderate exercise.
“For more than that, we have no evidence of additional cardiovascular benefit. It’s not going to get you to the Tokyo Olympics, but that’s what we need to be doing,” Dr. Vogel observed.
In another report from the Aerobics Center Longitudinal Study, investigators found that moderate-level cardiorespiratory fitness as defined by METs was associated with a 44% reduction in the risk of sudden cardiac death in men and women after adjustment for potential confounders, while high-level cardiorespiratory fitness was associated with a closely similar 48% reduction in risk. This applied to individuals who were hypertensive, overweight, and/or had poor health status, as well as to others (Mayo Clin Proc. 2016 Jul;91[7]:849-57).
All activity counts
Exercise physiologists speak of NEPA – nonexercise physical activity – such as taking out the garbage. Swedish investigators followed more than 4,200 individuals for an average of 12.5 years and found that high NEPA activity was independently associated with a 30% reduction in all-cause mortality and a 27% lower risk of a first cardiovascular disease event, compared with low NEPA. High NEPA in regular exercisers was associated with a lower rate of metabolic syndrome than in low-NEPA regular exercisers (Br J Sports Med. 2014 Feb;48[3]:233-8).
Don’t just sit there – stand!
The current federal physical activity guidelines place a new emphasis on the detrimental effects of sitting. A report on more than 221,000 participants in the Australian 45 and Up Study, with close to 1 million person-years of follow-up, demonstrated a linear inverse relationship between standing time per day and all-cause mortality. In a multivariate analysis adjusted for potential confounders, individuals who stood for 2-5 hours per day had a 10% lower risk of all-cause mortality than did those who stood for less than 2 hours. Standing for 5-8 hours was associated with a 15% relative risk reduction. And standing for more than 8 hours daily was linked to a 24% reduction in risk (Prev Med. 2014 Dec;69:187-91).
And it’s not just total daily sitting time that’s a risk factor. Prolonged, uninterrupted sedentary time was also associated with a dose-dependent increase in all-cause mortality in a prospective cohort study of nearly 8,000 U.S. adults (Ann Intern Med. 2017 Oct 3;167[7]:465-75).
“If you can’t walk around, talk to your patients standing up. That activity of getting out of your chair is lifesaving,” the cardiologist advised.
Get strong
Muscle-strengthening activity on at least 2 days/week is recommended in the federal guidelines because it’s independently associated with decreased all-cause mortality, even in individuals getting sufficient aerobic exercise, as shown in a large national study with 15-years’ follow-up (Prev Med. 2016 Jun;87:121-127).
“As we get older, we tend to forget about muscle. I work with the National Football League. These folks are pretty strong, but we never see diabetes in these very big players, who are often well over 300 lb. They’ve got a lot of muscle. If you want to prevent diabetes, be strong. It’s a very important factor,” Dr. Vogel said.
For the time constrained
Jogging is more time-efficient than brisk walking as a way to attain the maximum cardiovascular benefit of exercise. And the so-called “Weekend Warrior” study of nearly 64,000 U.K. adults showed that it’s okay to cram the full week’s worth of exercise into one or two sessions and be done with it. Compared with the inactive study participants, the weekend warriors had a 40% reduction in cardiovascular disease mortality, while individuals who split their physical activity up into three or more sessions per week had a nearly identical 41% relative risk reduction (JAMA Intern Med. 2017 Mar 1;177[3]:335-42).
Interval training is a standard way for athletes in training to improve their endurance by alternating short, intense exercise with brief recovery periods. It’s also a time saver: In one classic bicycling study, physically active men were randomized to standardized 2-week programs of sprint interval training or high-volume endurance training on the bike. The training time required to pass a rigorous cycling time trial test was 90% lower in the interval training group (J Physiol. 2006 Sep 15;575(Pt 3):901-11).
The same principle is applicable to the nonathlete interested in physical activity for heart health.
“When I run a couple of miles, I walk for 5 minutes, then maybe run for three-quarters of a mile, then walk again, then run. In interval training you get your heart rate up, and you drop it down. It’s a very good form of exercise. As a vascular biologist I know that if you put endothelial cells in a Petri dish and spin them real fast continuously, you will not get as good an improvement in endothelial function as if you spin the dish, stop it, spin it, stop it,” Dr. Vogel said.
High-volume exercise is safe, even with high coronary calcium
A clinically significant coronary artery calcification score of 100 Agatston units or more is no reason not to exercise. A Cooper Clinic report on nearly 22,000 middle-aged men without baseline cardiovascular disease who were followed for a mean of 10.4 years concluded that those in the highest-volume exercise group, many of whom were marathon runners and engaged in the equivalent of running for at least 5-6 hours/week at a pace of 10 minutes per mile, were 11% more likely to have an elevated baseline coronary artery calcification score than those who exercised less. But these highest-volume exercisers with elevated coronary calcium – their mean level was 807 Agatston units – had risks of all-cause and cardiovascular mortality that weren’t significantly different from those of men with elevated coronary calcium who exercised more moderately (JAMA Cardiol. 2019 Feb 1;4[2]:174-81).
Cardiac rehab
Dr. Vogel had harsh words for his physician colleagues with respect to the widespread underprescribing of cardiac rehabilitation programs.
“You guys are doing a crappy job with exercise in our most vulnerable patients: those who’ve had cardiovascular events,” he charged. “Cardiac rehabilitation is a Class I recommendation in our guidelines. And yet utilization in the United States is just 10%-20%. No other Class I recommendation is in that ballpark.”
A meta-analysis of 34 randomized trials totaling more than 6,000 post-MI patients concluded that those randomized to exercise-based cardiac rehabilitation had a 47% reduction in the risk of reinfarction, 36% lower cardiac mortality, and a 26% reduction in all-cause mortality (Am Heart J. 2011 Oct;162[4]:571-584.e2).
“The data show that cardiac rehabilitation is as effective as anything else we do in cardiovascular medicine. I understand that patients live far away, they don’t like to exercise – I’ve heard every excuse. But I am charging you with the responsibility of meeting a Class I recommendation that gets patients to live longer,” he declared.
Medicare now covers an enhanced, 72-session program called Intensive Cardiac Rehabilitation that teaches comprehensive lifestyle change and provides reasonable reimbursement. “It’s a good thing for our patients,” Dr. Vogel commented.
Yoga
For patients who are reluctant to pound the pavement, yoga may provide an alternative form of physical activity with tangible cardiovascular benefits. Dr. Vogel pointed to the Yoga-CaRe trial presented at the 2018 scientific sessions of the American Heart Association. Yoga-CaRe randomized 3,959 post-MI patients at 29 centers in India to a program of 13 supervised in-hospital yoga classes followed by yoga at home, or to a control group with three educational sessions. The rate of major adverse cardiovascular events over 42 months of follow-up was cut in half, compared with controls, in the 27% of participants who attended at least 10 of the 13 yoga classes. Their quality of life scores were higher, too.
Dr. Vogel reported serving as a paid consultant to the National Football League and the Pritikin Longevity Center. He is on the speaker’s bureau for Sanofi and Regeneron.
SNOWMASS, COLO. – Physical activity is potent medicine, and it doesn’t take all that much of it to derive the maximum cardiovascular benefit: namely, the equivalent of a brisk hour-long walk 5 days/week or jogging at a 10-minute-per-mile pace for half an hour twice weekly, Robert A. Vogel, MD, asserted at the annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.
“I’m not telling you to run marathons. said Dr. Vogel, a cardiologist at the University of Colorado at Denver, Aurora, with a longstanding interest in preventive cardiology.
He presented selected highlights from the massive evidence base underlying the recommendations put forth in the current comprehensive U.S. Department of Health & Human Services Physical Activity Guidelines for Americans.
One particularly compelling chunk of evidence comes from a Taiwanese government–funded prospective cohort study of more than 416,000 individuals followed for an average of 8 years. A key finding: 15 minutes of moderate-intensity physical activity daily was associated with a 14% reduction in the relative risk of all-cause mortality and a 19% reduction in death caused by cardiovascular disease, compared with that of inactive individuals. Moreover, each additional 15 minutes of daily moderate exercise further reduced mortality by 4%. These benefits extended across the full age spectrum of both sexes and applied to patients with cardiovascular disease (Lancet. 2011 Oct 1;378[9798]:1244-53).
“That’s a very impressive result for modest physical activity,” the cardiologist commented.
Data on more than 50,000 adult participants in the Aerobics Center Longitudinal Study based at the Cooper Clinic in Dallas show that vigorous exercise in the form of running at 6 mph for half an hour twice weekly, or a total of 10 metabolic equivalent of task hours (MET-HR) per week, was associated with a roughly 40% reduction in cardiovascular disease mortality. Importantly, 20, 40, or 50 MET-HR/week of vigorous exercise conferred no further survival benefit (J Am Coll Cardiol. 2014 Aug 5;64[5]:472-81). The same group showed that the sweet spot for moderate physical activity in terms of reduced cardiovascular mortality was brisk walking for an hour daily 5 days/week, for a total of 20 MET-HR, which was also associated with roughly a 40% risk reduction compared to inactivity. At that point the benefit plateaued, with no further mortality reduction noted with additional MET-HR of moderate exercise.
“For more than that, we have no evidence of additional cardiovascular benefit. It’s not going to get you to the Tokyo Olympics, but that’s what we need to be doing,” Dr. Vogel observed.
In another report from the Aerobics Center Longitudinal Study, investigators found that moderate-level cardiorespiratory fitness as defined by METs was associated with a 44% reduction in the risk of sudden cardiac death in men and women after adjustment for potential confounders, while high-level cardiorespiratory fitness was associated with a closely similar 48% reduction in risk. This applied to individuals who were hypertensive, overweight, and/or had poor health status, as well as to others (Mayo Clin Proc. 2016 Jul;91[7]:849-57).
All activity counts
Exercise physiologists speak of NEPA – nonexercise physical activity – such as taking out the garbage. Swedish investigators followed more than 4,200 individuals for an average of 12.5 years and found that high NEPA activity was independently associated with a 30% reduction in all-cause mortality and a 27% lower risk of a first cardiovascular disease event, compared with low NEPA. High NEPA in regular exercisers was associated with a lower rate of metabolic syndrome than in low-NEPA regular exercisers (Br J Sports Med. 2014 Feb;48[3]:233-8).
Don’t just sit there – stand!
The current federal physical activity guidelines place a new emphasis on the detrimental effects of sitting. A report on more than 221,000 participants in the Australian 45 and Up Study, with close to 1 million person-years of follow-up, demonstrated a linear inverse relationship between standing time per day and all-cause mortality. In a multivariate analysis adjusted for potential confounders, individuals who stood for 2-5 hours per day had a 10% lower risk of all-cause mortality than did those who stood for less than 2 hours. Standing for 5-8 hours was associated with a 15% relative risk reduction. And standing for more than 8 hours daily was linked to a 24% reduction in risk (Prev Med. 2014 Dec;69:187-91).
And it’s not just total daily sitting time that’s a risk factor. Prolonged, uninterrupted sedentary time was also associated with a dose-dependent increase in all-cause mortality in a prospective cohort study of nearly 8,000 U.S. adults (Ann Intern Med. 2017 Oct 3;167[7]:465-75).
“If you can’t walk around, talk to your patients standing up. That activity of getting out of your chair is lifesaving,” the cardiologist advised.
Get strong
Muscle-strengthening activity on at least 2 days/week is recommended in the federal guidelines because it’s independently associated with decreased all-cause mortality, even in individuals getting sufficient aerobic exercise, as shown in a large national study with 15-years’ follow-up (Prev Med. 2016 Jun;87:121-127).
“As we get older, we tend to forget about muscle. I work with the National Football League. These folks are pretty strong, but we never see diabetes in these very big players, who are often well over 300 lb. They’ve got a lot of muscle. If you want to prevent diabetes, be strong. It’s a very important factor,” Dr. Vogel said.
For the time constrained
Jogging is more time-efficient than brisk walking as a way to attain the maximum cardiovascular benefit of exercise. And the so-called “Weekend Warrior” study of nearly 64,000 U.K. adults showed that it’s okay to cram the full week’s worth of exercise into one or two sessions and be done with it. Compared with the inactive study participants, the weekend warriors had a 40% reduction in cardiovascular disease mortality, while individuals who split their physical activity up into three or more sessions per week had a nearly identical 41% relative risk reduction (JAMA Intern Med. 2017 Mar 1;177[3]:335-42).
Interval training is a standard way for athletes in training to improve their endurance by alternating short, intense exercise with brief recovery periods. It’s also a time saver: In one classic bicycling study, physically active men were randomized to standardized 2-week programs of sprint interval training or high-volume endurance training on the bike. The training time required to pass a rigorous cycling time trial test was 90% lower in the interval training group (J Physiol. 2006 Sep 15;575(Pt 3):901-11).
The same principle is applicable to the nonathlete interested in physical activity for heart health.
“When I run a couple of miles, I walk for 5 minutes, then maybe run for three-quarters of a mile, then walk again, then run. In interval training you get your heart rate up, and you drop it down. It’s a very good form of exercise. As a vascular biologist I know that if you put endothelial cells in a Petri dish and spin them real fast continuously, you will not get as good an improvement in endothelial function as if you spin the dish, stop it, spin it, stop it,” Dr. Vogel said.
High-volume exercise is safe, even with high coronary calcium
A clinically significant coronary artery calcification score of 100 Agatston units or more is no reason not to exercise. A Cooper Clinic report on nearly 22,000 middle-aged men without baseline cardiovascular disease who were followed for a mean of 10.4 years concluded that those in the highest-volume exercise group, many of whom were marathon runners and engaged in the equivalent of running for at least 5-6 hours/week at a pace of 10 minutes per mile, were 11% more likely to have an elevated baseline coronary artery calcification score than those who exercised less. But these highest-volume exercisers with elevated coronary calcium – their mean level was 807 Agatston units – had risks of all-cause and cardiovascular mortality that weren’t significantly different from those of men with elevated coronary calcium who exercised more moderately (JAMA Cardiol. 2019 Feb 1;4[2]:174-81).
Cardiac rehab
Dr. Vogel had harsh words for his physician colleagues with respect to the widespread underprescribing of cardiac rehabilitation programs.
“You guys are doing a crappy job with exercise in our most vulnerable patients: those who’ve had cardiovascular events,” he charged. “Cardiac rehabilitation is a Class I recommendation in our guidelines. And yet utilization in the United States is just 10%-20%. No other Class I recommendation is in that ballpark.”
A meta-analysis of 34 randomized trials totaling more than 6,000 post-MI patients concluded that those randomized to exercise-based cardiac rehabilitation had a 47% reduction in the risk of reinfarction, 36% lower cardiac mortality, and a 26% reduction in all-cause mortality (Am Heart J. 2011 Oct;162[4]:571-584.e2).
“The data show that cardiac rehabilitation is as effective as anything else we do in cardiovascular medicine. I understand that patients live far away, they don’t like to exercise – I’ve heard every excuse. But I am charging you with the responsibility of meeting a Class I recommendation that gets patients to live longer,” he declared.
Medicare now covers an enhanced, 72-session program called Intensive Cardiac Rehabilitation that teaches comprehensive lifestyle change and provides reasonable reimbursement. “It’s a good thing for our patients,” Dr. Vogel commented.
Yoga
For patients who are reluctant to pound the pavement, yoga may provide an alternative form of physical activity with tangible cardiovascular benefits. Dr. Vogel pointed to the Yoga-CaRe trial presented at the 2018 scientific sessions of the American Heart Association. Yoga-CaRe randomized 3,959 post-MI patients at 29 centers in India to a program of 13 supervised in-hospital yoga classes followed by yoga at home, or to a control group with three educational sessions. The rate of major adverse cardiovascular events over 42 months of follow-up was cut in half, compared with controls, in the 27% of participants who attended at least 10 of the 13 yoga classes. Their quality of life scores were higher, too.
Dr. Vogel reported serving as a paid consultant to the National Football League and the Pritikin Longevity Center. He is on the speaker’s bureau for Sanofi and Regeneron.
EXPERT ANALYSIS FROM ACC SNOWMASS 2020