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How to pump up the donor heart pool
COLORADO SPRINGS – Diminished left ventricular systolic function alone should not be used as a basis for declining a donor heart for transplantation, Agustin Sibona, MD, asserted at the annual meeting of the Western Thoracic Surgical Association.
“Expansion of the donor pool to include more of these organs is appropriate,” said Dr. Sibona of Loma Linda (Calif.) University.
He presented an analysis of the United Network for Organ Sharing database that encompassed all adult isolated first-time heart transplants in the United States from 2000 through March 2016.
“Carefully selected potential donor hearts with LVEF of 30% or higher should not be excluded from consideration of transplantation on the basis of depressed LVEF alone,” he concluded. “We’re not saying we should use every heart that has an EF of 35% or 45%. We say you should thoroughly evaluate those patients and those hearts and consider them.”
Roughly 500,000 people develop new end-stage heart failure each year. Heart transplantation has long been considered the definitive therapy for this condition. However, heart transplantation rates have remained static at 2,000-2,500 per year in the United States for the past 15 years because of the shortage of donor organs.
Previous work by Dr. Sibona’s senior coinvestigators has documented that 19% of potential donor hearts are not utilized for transplant solely based upon the presence of left ventricular dysfunction. That’s about 1,300 hearts per year.
“About 60% of those hearts had an LVEF greater than 40%. That’s 785 hearts. If only half of those are used, that still represents an increase in the domestic transplant rate of almost 20%,” he observed.
Twenty-one patients in the study received a heart with an LVEF of 20%-29.9%. They had an unacceptably high perioperative mortality.
There was no significant difference between the LVEF groups in terms of race, cause of death, or ischemic time.
Mean transplantation hospital length of stay varied inversely with donor heart LVEF, from 20.3 days in patients with a normal LVEF, to 23.9 days with an LVEF of 40%-49.9%, and 31.1 days with an LVEF of 30%-39.9%.
Dr. Sibona replied that unfortunately the UNOS database is not informative on that score.
Dr. Kwon offered a practical reservation about embracing the use of compromised donor hearts: “Ninety-one percent of programs in the U.S. do less than 30 heart transplants per year, and 76% do less than 20. Smaller programs won’t necessarily have the luxury of 6,000 days to see if their survival statistics bear out. If they have two or three deaths per year, that’s enough to get a notice from UNOS and CMS and private payers. So I would note some caution in that regard.”
He also posed a question: In this new era of highly effective left ventricular assist devices serving as a long-term bridge to transplant, does it make sense to turn to dysfunctional donor hearts?
“Ventricular assist devices are an evolving technology,” Dr. Sibona responded. “Short-term outcomes are equivalent to transplant, but the devices often have complications: GI bleed, stroke, thrombosis, and infections. So we still believe that heart transplantation is the gold standard for treatment. Remember, these patients have end-stage heart failure. Many can’t get out of bed without shortness of breath. So, yes, I would take those hearts.”
He reported having no financial conflicts regarding his study, which was supported by Loma Linda and Stanford universities.
COLORADO SPRINGS – Diminished left ventricular systolic function alone should not be used as a basis for declining a donor heart for transplantation, Agustin Sibona, MD, asserted at the annual meeting of the Western Thoracic Surgical Association.
“Expansion of the donor pool to include more of these organs is appropriate,” said Dr. Sibona of Loma Linda (Calif.) University.
He presented an analysis of the United Network for Organ Sharing database that encompassed all adult isolated first-time heart transplants in the United States from 2000 through March 2016.
“Carefully selected potential donor hearts with LVEF of 30% or higher should not be excluded from consideration of transplantation on the basis of depressed LVEF alone,” he concluded. “We’re not saying we should use every heart that has an EF of 35% or 45%. We say you should thoroughly evaluate those patients and those hearts and consider them.”
Roughly 500,000 people develop new end-stage heart failure each year. Heart transplantation has long been considered the definitive therapy for this condition. However, heart transplantation rates have remained static at 2,000-2,500 per year in the United States for the past 15 years because of the shortage of donor organs.
Previous work by Dr. Sibona’s senior coinvestigators has documented that 19% of potential donor hearts are not utilized for transplant solely based upon the presence of left ventricular dysfunction. That’s about 1,300 hearts per year.
“About 60% of those hearts had an LVEF greater than 40%. That’s 785 hearts. If only half of those are used, that still represents an increase in the domestic transplant rate of almost 20%,” he observed.
Twenty-one patients in the study received a heart with an LVEF of 20%-29.9%. They had an unacceptably high perioperative mortality.
There was no significant difference between the LVEF groups in terms of race, cause of death, or ischemic time.
Mean transplantation hospital length of stay varied inversely with donor heart LVEF, from 20.3 days in patients with a normal LVEF, to 23.9 days with an LVEF of 40%-49.9%, and 31.1 days with an LVEF of 30%-39.9%.
Dr. Sibona replied that unfortunately the UNOS database is not informative on that score.
Dr. Kwon offered a practical reservation about embracing the use of compromised donor hearts: “Ninety-one percent of programs in the U.S. do less than 30 heart transplants per year, and 76% do less than 20. Smaller programs won’t necessarily have the luxury of 6,000 days to see if their survival statistics bear out. If they have two or three deaths per year, that’s enough to get a notice from UNOS and CMS and private payers. So I would note some caution in that regard.”
He also posed a question: In this new era of highly effective left ventricular assist devices serving as a long-term bridge to transplant, does it make sense to turn to dysfunctional donor hearts?
“Ventricular assist devices are an evolving technology,” Dr. Sibona responded. “Short-term outcomes are equivalent to transplant, but the devices often have complications: GI bleed, stroke, thrombosis, and infections. So we still believe that heart transplantation is the gold standard for treatment. Remember, these patients have end-stage heart failure. Many can’t get out of bed without shortness of breath. So, yes, I would take those hearts.”
He reported having no financial conflicts regarding his study, which was supported by Loma Linda and Stanford universities.
COLORADO SPRINGS – Diminished left ventricular systolic function alone should not be used as a basis for declining a donor heart for transplantation, Agustin Sibona, MD, asserted at the annual meeting of the Western Thoracic Surgical Association.
“Expansion of the donor pool to include more of these organs is appropriate,” said Dr. Sibona of Loma Linda (Calif.) University.
He presented an analysis of the United Network for Organ Sharing database that encompassed all adult isolated first-time heart transplants in the United States from 2000 through March 2016.
“Carefully selected potential donor hearts with LVEF of 30% or higher should not be excluded from consideration of transplantation on the basis of depressed LVEF alone,” he concluded. “We’re not saying we should use every heart that has an EF of 35% or 45%. We say you should thoroughly evaluate those patients and those hearts and consider them.”
Roughly 500,000 people develop new end-stage heart failure each year. Heart transplantation has long been considered the definitive therapy for this condition. However, heart transplantation rates have remained static at 2,000-2,500 per year in the United States for the past 15 years because of the shortage of donor organs.
Previous work by Dr. Sibona’s senior coinvestigators has documented that 19% of potential donor hearts are not utilized for transplant solely based upon the presence of left ventricular dysfunction. That’s about 1,300 hearts per year.
“About 60% of those hearts had an LVEF greater than 40%. That’s 785 hearts. If only half of those are used, that still represents an increase in the domestic transplant rate of almost 20%,” he observed.
Twenty-one patients in the study received a heart with an LVEF of 20%-29.9%. They had an unacceptably high perioperative mortality.
There was no significant difference between the LVEF groups in terms of race, cause of death, or ischemic time.
Mean transplantation hospital length of stay varied inversely with donor heart LVEF, from 20.3 days in patients with a normal LVEF, to 23.9 days with an LVEF of 40%-49.9%, and 31.1 days with an LVEF of 30%-39.9%.
Dr. Sibona replied that unfortunately the UNOS database is not informative on that score.
Dr. Kwon offered a practical reservation about embracing the use of compromised donor hearts: “Ninety-one percent of programs in the U.S. do less than 30 heart transplants per year, and 76% do less than 20. Smaller programs won’t necessarily have the luxury of 6,000 days to see if their survival statistics bear out. If they have two or three deaths per year, that’s enough to get a notice from UNOS and CMS and private payers. So I would note some caution in that regard.”
He also posed a question: In this new era of highly effective left ventricular assist devices serving as a long-term bridge to transplant, does it make sense to turn to dysfunctional donor hearts?
“Ventricular assist devices are an evolving technology,” Dr. Sibona responded. “Short-term outcomes are equivalent to transplant, but the devices often have complications: GI bleed, stroke, thrombosis, and infections. So we still believe that heart transplantation is the gold standard for treatment. Remember, these patients have end-stage heart failure. Many can’t get out of bed without shortness of breath. So, yes, I would take those hearts.”
He reported having no financial conflicts regarding his study, which was supported by Loma Linda and Stanford universities.
AT THE WTSA ANNUAL MEETING
Key clinical point:
Major finding: Survival of heart transplant recipients whose donor organ had left ventricular systolic dysfunction with an LVEF as low as 30%-39% was not significantly less than for those with a normal donor heart.
Data source: A retrospective study of all of the nearly 31,000 isolated first-time adult heart transplants performed in the U.S. during 2000-March 2016.
Disclosures: Loma Linda and Stanford universities supported the study. The presenter reported having no financial conflicts.
VIDEO: Cardiovascular events in rheumatoid arthritis have decreased over decades
MADRID – Recent improvements in the management of rheumatoid arthritis may have had a positive impact on common cardiovascular comorbidities, according to the results of a systematic review and meta-analysis.
Risk ratios (RR) for several CV events in rheumatoid arthritis (RA) patients were found to be lower for data published after 2000 and up to March 2016 when compared with data published up until 2000. Indeed, comparing these two time periods, French researchers found that the RR for myocardial infarction (MI) were a respective 1.32 and 1.18, for heart failure a respective 1.25 and 1.17, and for CV mortality a respective 1.21 and 1.07.
“Systemic inflammation is the cornerstone of both rheumatoid arthritis and atherosclerosis,” Cécile Gaujoux-Viala, MD, PhD, professor of rheumatology at Montpellier University, Nîmes, France, and chief of the rheumatology service at Nîmes University Hospital, said during a press briefing at the European Congress of Rheumatology.
“Over the past 15 years, new treatment strategies such as ‘tight control,’ ‘treat-to-target,’ methotrexate optimization, and use of biologic DMARDs [disease-modifying antirheumatic drugs] have led to better control of this inflammation,” Dr. Gaujoux-Viala added.
The aim of the meta-analysis was to look at the overall risk for CV events in RA patients versus the general population, she said, as well as to see if there had been any temporal shift by analyzing data obtained within two time periods – before 2000 and after 2000.
A systematic literature review was performed using the PubMed and Cochrane Library databases to search for observational studies that provided data about the occurrence of CV events in RA patients and controls. Of 5,714 papers that included reports of stroke, MI, heart failure, or CV death, 28 had the necessary data that could be used for the meta-analysis. Overall, the 28 studies included 227,871 RA patients, with a mean age of 55 years.
Results showed that RA patients had a 17% increased risk for stroke versus controls overall (P = .002), with a RR of 1.17. The RRs were 1.12 before 2000 and 1.23 after 2000, making stroke the only CV event that did not appear to show a downward trend.
Compared with the general population, RA patients had a 24% excess risk of MI, a 22% excess risk of heart failure, and a 18% excess risk of dying from a CV event (all P less than .00001).
These data provide “confirmation of an increased CV risk in RA patients compared to the general population,” said Dr. Gaujoux-Viala, who also discussed the study and its implications in a video interview.
Commenting on the study, Philip J. Mease, MD, of the University of Washington, Seattle, wondered where the studies used in the meta-analysis had been performed because of the potential impact that reduced access to CV medications or prevention strategies in certain countries could have on the results. However, the investigators did not determine where each of the studies used in the review took place.
Dr. Gaujoux-Viala had no relevant conflicts of interest to disclose.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
MADRID – Recent improvements in the management of rheumatoid arthritis may have had a positive impact on common cardiovascular comorbidities, according to the results of a systematic review and meta-analysis.
Risk ratios (RR) for several CV events in rheumatoid arthritis (RA) patients were found to be lower for data published after 2000 and up to March 2016 when compared with data published up until 2000. Indeed, comparing these two time periods, French researchers found that the RR for myocardial infarction (MI) were a respective 1.32 and 1.18, for heart failure a respective 1.25 and 1.17, and for CV mortality a respective 1.21 and 1.07.
“Systemic inflammation is the cornerstone of both rheumatoid arthritis and atherosclerosis,” Cécile Gaujoux-Viala, MD, PhD, professor of rheumatology at Montpellier University, Nîmes, France, and chief of the rheumatology service at Nîmes University Hospital, said during a press briefing at the European Congress of Rheumatology.
“Over the past 15 years, new treatment strategies such as ‘tight control,’ ‘treat-to-target,’ methotrexate optimization, and use of biologic DMARDs [disease-modifying antirheumatic drugs] have led to better control of this inflammation,” Dr. Gaujoux-Viala added.
The aim of the meta-analysis was to look at the overall risk for CV events in RA patients versus the general population, she said, as well as to see if there had been any temporal shift by analyzing data obtained within two time periods – before 2000 and after 2000.
A systematic literature review was performed using the PubMed and Cochrane Library databases to search for observational studies that provided data about the occurrence of CV events in RA patients and controls. Of 5,714 papers that included reports of stroke, MI, heart failure, or CV death, 28 had the necessary data that could be used for the meta-analysis. Overall, the 28 studies included 227,871 RA patients, with a mean age of 55 years.
Results showed that RA patients had a 17% increased risk for stroke versus controls overall (P = .002), with a RR of 1.17. The RRs were 1.12 before 2000 and 1.23 after 2000, making stroke the only CV event that did not appear to show a downward trend.
Compared with the general population, RA patients had a 24% excess risk of MI, a 22% excess risk of heart failure, and a 18% excess risk of dying from a CV event (all P less than .00001).
These data provide “confirmation of an increased CV risk in RA patients compared to the general population,” said Dr. Gaujoux-Viala, who also discussed the study and its implications in a video interview.
Commenting on the study, Philip J. Mease, MD, of the University of Washington, Seattle, wondered where the studies used in the meta-analysis had been performed because of the potential impact that reduced access to CV medications or prevention strategies in certain countries could have on the results. However, the investigators did not determine where each of the studies used in the review took place.
Dr. Gaujoux-Viala had no relevant conflicts of interest to disclose.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
MADRID – Recent improvements in the management of rheumatoid arthritis may have had a positive impact on common cardiovascular comorbidities, according to the results of a systematic review and meta-analysis.
Risk ratios (RR) for several CV events in rheumatoid arthritis (RA) patients were found to be lower for data published after 2000 and up to March 2016 when compared with data published up until 2000. Indeed, comparing these two time periods, French researchers found that the RR for myocardial infarction (MI) were a respective 1.32 and 1.18, for heart failure a respective 1.25 and 1.17, and for CV mortality a respective 1.21 and 1.07.
“Systemic inflammation is the cornerstone of both rheumatoid arthritis and atherosclerosis,” Cécile Gaujoux-Viala, MD, PhD, professor of rheumatology at Montpellier University, Nîmes, France, and chief of the rheumatology service at Nîmes University Hospital, said during a press briefing at the European Congress of Rheumatology.
“Over the past 15 years, new treatment strategies such as ‘tight control,’ ‘treat-to-target,’ methotrexate optimization, and use of biologic DMARDs [disease-modifying antirheumatic drugs] have led to better control of this inflammation,” Dr. Gaujoux-Viala added.
The aim of the meta-analysis was to look at the overall risk for CV events in RA patients versus the general population, she said, as well as to see if there had been any temporal shift by analyzing data obtained within two time periods – before 2000 and after 2000.
A systematic literature review was performed using the PubMed and Cochrane Library databases to search for observational studies that provided data about the occurrence of CV events in RA patients and controls. Of 5,714 papers that included reports of stroke, MI, heart failure, or CV death, 28 had the necessary data that could be used for the meta-analysis. Overall, the 28 studies included 227,871 RA patients, with a mean age of 55 years.
Results showed that RA patients had a 17% increased risk for stroke versus controls overall (P = .002), with a RR of 1.17. The RRs were 1.12 before 2000 and 1.23 after 2000, making stroke the only CV event that did not appear to show a downward trend.
Compared with the general population, RA patients had a 24% excess risk of MI, a 22% excess risk of heart failure, and a 18% excess risk of dying from a CV event (all P less than .00001).
These data provide “confirmation of an increased CV risk in RA patients compared to the general population,” said Dr. Gaujoux-Viala, who also discussed the study and its implications in a video interview.
Commenting on the study, Philip J. Mease, MD, of the University of Washington, Seattle, wondered where the studies used in the meta-analysis had been performed because of the potential impact that reduced access to CV medications or prevention strategies in certain countries could have on the results. However, the investigators did not determine where each of the studies used in the review took place.
Dr. Gaujoux-Viala had no relevant conflicts of interest to disclose.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT THE EULAR 2017 CONGRESS
Key clinical point:
Major finding: Risk ratios for myocardial infarction, heart failure, and CV mortality were lower between the period of 2000-2016 than for the period up to 2000.
Data source: Meta-analysis of 28 studies published up to March 2016 that provided data on CV event rates in RA patients and the general population.
Disclosures: Dr. Gaujoux-Viala had no relevant conflicts of interest to disclose.
Lithoplasty tames heavily calcified coronary lesions
PARIS – A novel therapeutic ultrasound-based technology known as lithoplasty is turning heads in interventional cardiology and vascular medicine because it addresses the bane of interventionalists’ existence: complex, heavily calcified coronary and peripheral artery lesions.
“Calcification is something we deal with every day in interventional cardiology. It makes the procedures more expensive, longer, and in fact several recent studies have shown that the complication rate for calcified lesions is higher than for any other lesion subtype. Calcification is the next big thing that we’re trying to take on in interventional cardiology,” Todd J. Brinton, MD, observed at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
At EuroPCR, he presented the results of DISRUPT CAD, a seven-center study in which 60 patients with heavily calcified coronary lesions underwent lithoplasty in order to facilitate stent placement. The study met all of its safety and performance endpoints. As a result, the week prior to EuroPCR the European regulatory agency granted marketing approval for Shockwave Medical’s coronary lithoplasty system; the indication is for coronary vessel preparation prior to stenting. A large phase III U.S. trial aimed at gaining FDA approval is planned.
Moreover, on the basis of the earlier favorable DISRUPT PAD trial, lithoplasty has already been approved for treatment of peripheral artery disease (PAD) in Europe since late 2015 and by the FDA since September 2016. Now underway is DISRUPT PAD III, a large postmarketing randomized trial comparing lithoplasty with conventional balloon angioplasty in patients with heavily calcified PAD, added Dr. Brinton, an interventional cardiologist at Stanford (Calif.) University and cofounder of Shockwave Medical.
Lithoplasty is a potentially transformative technology which he described as “lithotripsy inside a balloon.” Lithotripsy has an established 30-year track record for the safe treatment of kidney stones. However, lithotripsy utilizes focused ultrasound, while lithoplasty relies upon circumferential unfocused therapeutic ultrasound delivered by miniaturized emitters placed inside a 12-mm intravascular balloon. The balloon is crossed to the target lesion, inflated to a modest pressure of 4 atmospheres, then the operator delivers lithoplasty pulses lasting over 1 microsec in duration at a rate of 1/sec for 10 seconds in order to fracture the thick intramedial calcium plaque, allowing the lesion to open up and thereby normalize vessel compliance.
“Once you’ve cracked the calcium you can easily dilate the lesion. It’s the calcium that’s restricting the ability to dilate. The real fundamental need here is to maximize acute gain to get really good stent apposition. We’re trying to get expansion,” the cardiologist explained.
That was readily achieved in the DISRUPT CAD study. The 60 participants had reference vessel diameters of 2.5-4.0 mm, with an average target lesion length of 20 mm. The calcification was heavy, covering on average 270 degrees of the vessel circumference as measured by optical coherence tomography, with an average calcium thickness of 0.97 mm and a calcified segment length of 22.3 mm.
The mean stent expansion was 112%. The minimum luminal diameter improved from 0.9 mm pretreatment to 2.6 mm post treatment, for an acute gain of 1.7 mm. The amount of acute gain was similar across the full range of vessel diameters.
The mean diameter stenosis went from 68% pretreatment to 13% post-treatment.
The primary safety endpoint was the 30-day rate of MACE, defined as cardiac death, MI, or target vessel revascularization. The rate was 5%, consisting of 3 patients with mild non–Q-wave MI defined by creatine kinase–MB elevations more than three times the upper limit of normal. The 6-month MACE rate was 8.5%, which included the three non–Q-wave MIs plus two cardiac deaths not related to the procedure or technology.
Final angiographic results adjudicated in a central core laboratory showed no perforations, abrupt closures, slow or no reflow events, or residual dissections. These are complications commonly seen with debulking devices such as rotational or orbital atherectomy, Dr. Brinton noted.
The primary performance endpoint in DISRUPT CAD was clinical success, defined as a residual stenosis of less than 50% post PCI with no in-hospital MACE. This was achieved in 57 of 60 patients, or 95%. The device was successfully delivered to the target lesion with subsequent performance of lithoplasty in 59 of 60 patients. An even more flexible and deliverable device will be released in the coming year, according to the cardiologist.
“I’d say the take-home is that the disease has changed,” Dr. Brinton commented. “It’s not the same disease that we had when Gruentzig did his first balloon angioplasty. These lesions are more calcified, more complex, yet for the most part we use the same balloon we’ve been using for the last 40 years. So lithoplasty is really an attempt to modernize the therapy in a new patient subset we now take care of who are much more complicated than the patients we originally took care of.”
“The reality is, we’re having difficulty taking care of these patients. For myself as an interventionalist, it’s not uncommon to look around the table and see a massive amount of tools when we’re doing these complex cases. Lithoplasty is intended to bring the simplicity. I would say it’s not necessarily to make the best operators better, it’s to bring all operators up to the ability to take on these complex lesions that are now usually reserved for high-volume centers that can do debulking,” he added.
Session cochair David R. Holmes Jr., MD, of the Mayo Clinic in Rochester, Minn., pronounced lithoplasty “tremendously exciting.” He and the other panelists focused on questions of safety and potential collateral damage: Where does the calcified debris go? What are the effects of the unfocused sonic pressure waves on noncalcified plaque? How hot does the vessel get?
Dr. Brinton replied that thick calcium plaque is located mostly in the medial vessel wall and stays there after fracturing. That’s why distal embolization wasn’t an issue in DISRUPT CAD. In animal studies, even at 20 times the energy dose used in clinical practice, lithoplasty had no effect on softer, noncalcified plaque or normal tissue. Vessel temperature increases by about 1.2 degrees C during lithoplasty, which isn’t sufficient to cause injury or drive restenosis.
Elsewhere at EuroPCR, Alberto Cremonesi, MD, who chaired a press conference where Dr. Brinton presented highlights of DISRUPT CAD, declared lithoplasty is “in my mind a real breakthrough, not only for coronary disease but also for PAD.”
Is it possible that stand-alone lithoplasty could reduce the need for multiple stents in longer coronary lesions, instead making possible more focal stenting? asked Dr. Cremonesi of Maria Cecilia Hospital in Cotignola, Italy.
That’s one of several possibilities worthy of future investigation, Dr. Brinton replied. Lithoplasty might also facilitate the results obtainable with bioresorbable coronary scaffolds or drug-coated balloons, he added.
He noted that as cofounder of and a consultant to Shockwave Medical, he has a sizable financial involvement with the company.
PARIS – A novel therapeutic ultrasound-based technology known as lithoplasty is turning heads in interventional cardiology and vascular medicine because it addresses the bane of interventionalists’ existence: complex, heavily calcified coronary and peripheral artery lesions.
“Calcification is something we deal with every day in interventional cardiology. It makes the procedures more expensive, longer, and in fact several recent studies have shown that the complication rate for calcified lesions is higher than for any other lesion subtype. Calcification is the next big thing that we’re trying to take on in interventional cardiology,” Todd J. Brinton, MD, observed at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
At EuroPCR, he presented the results of DISRUPT CAD, a seven-center study in which 60 patients with heavily calcified coronary lesions underwent lithoplasty in order to facilitate stent placement. The study met all of its safety and performance endpoints. As a result, the week prior to EuroPCR the European regulatory agency granted marketing approval for Shockwave Medical’s coronary lithoplasty system; the indication is for coronary vessel preparation prior to stenting. A large phase III U.S. trial aimed at gaining FDA approval is planned.
Moreover, on the basis of the earlier favorable DISRUPT PAD trial, lithoplasty has already been approved for treatment of peripheral artery disease (PAD) in Europe since late 2015 and by the FDA since September 2016. Now underway is DISRUPT PAD III, a large postmarketing randomized trial comparing lithoplasty with conventional balloon angioplasty in patients with heavily calcified PAD, added Dr. Brinton, an interventional cardiologist at Stanford (Calif.) University and cofounder of Shockwave Medical.
Lithoplasty is a potentially transformative technology which he described as “lithotripsy inside a balloon.” Lithotripsy has an established 30-year track record for the safe treatment of kidney stones. However, lithotripsy utilizes focused ultrasound, while lithoplasty relies upon circumferential unfocused therapeutic ultrasound delivered by miniaturized emitters placed inside a 12-mm intravascular balloon. The balloon is crossed to the target lesion, inflated to a modest pressure of 4 atmospheres, then the operator delivers lithoplasty pulses lasting over 1 microsec in duration at a rate of 1/sec for 10 seconds in order to fracture the thick intramedial calcium plaque, allowing the lesion to open up and thereby normalize vessel compliance.
“Once you’ve cracked the calcium you can easily dilate the lesion. It’s the calcium that’s restricting the ability to dilate. The real fundamental need here is to maximize acute gain to get really good stent apposition. We’re trying to get expansion,” the cardiologist explained.
That was readily achieved in the DISRUPT CAD study. The 60 participants had reference vessel diameters of 2.5-4.0 mm, with an average target lesion length of 20 mm. The calcification was heavy, covering on average 270 degrees of the vessel circumference as measured by optical coherence tomography, with an average calcium thickness of 0.97 mm and a calcified segment length of 22.3 mm.
The mean stent expansion was 112%. The minimum luminal diameter improved from 0.9 mm pretreatment to 2.6 mm post treatment, for an acute gain of 1.7 mm. The amount of acute gain was similar across the full range of vessel diameters.
The mean diameter stenosis went from 68% pretreatment to 13% post-treatment.
The primary safety endpoint was the 30-day rate of MACE, defined as cardiac death, MI, or target vessel revascularization. The rate was 5%, consisting of 3 patients with mild non–Q-wave MI defined by creatine kinase–MB elevations more than three times the upper limit of normal. The 6-month MACE rate was 8.5%, which included the three non–Q-wave MIs plus two cardiac deaths not related to the procedure or technology.
Final angiographic results adjudicated in a central core laboratory showed no perforations, abrupt closures, slow or no reflow events, or residual dissections. These are complications commonly seen with debulking devices such as rotational or orbital atherectomy, Dr. Brinton noted.
The primary performance endpoint in DISRUPT CAD was clinical success, defined as a residual stenosis of less than 50% post PCI with no in-hospital MACE. This was achieved in 57 of 60 patients, or 95%. The device was successfully delivered to the target lesion with subsequent performance of lithoplasty in 59 of 60 patients. An even more flexible and deliverable device will be released in the coming year, according to the cardiologist.
“I’d say the take-home is that the disease has changed,” Dr. Brinton commented. “It’s not the same disease that we had when Gruentzig did his first balloon angioplasty. These lesions are more calcified, more complex, yet for the most part we use the same balloon we’ve been using for the last 40 years. So lithoplasty is really an attempt to modernize the therapy in a new patient subset we now take care of who are much more complicated than the patients we originally took care of.”
“The reality is, we’re having difficulty taking care of these patients. For myself as an interventionalist, it’s not uncommon to look around the table and see a massive amount of tools when we’re doing these complex cases. Lithoplasty is intended to bring the simplicity. I would say it’s not necessarily to make the best operators better, it’s to bring all operators up to the ability to take on these complex lesions that are now usually reserved for high-volume centers that can do debulking,” he added.
Session cochair David R. Holmes Jr., MD, of the Mayo Clinic in Rochester, Minn., pronounced lithoplasty “tremendously exciting.” He and the other panelists focused on questions of safety and potential collateral damage: Where does the calcified debris go? What are the effects of the unfocused sonic pressure waves on noncalcified plaque? How hot does the vessel get?
Dr. Brinton replied that thick calcium plaque is located mostly in the medial vessel wall and stays there after fracturing. That’s why distal embolization wasn’t an issue in DISRUPT CAD. In animal studies, even at 20 times the energy dose used in clinical practice, lithoplasty had no effect on softer, noncalcified plaque or normal tissue. Vessel temperature increases by about 1.2 degrees C during lithoplasty, which isn’t sufficient to cause injury or drive restenosis.
Elsewhere at EuroPCR, Alberto Cremonesi, MD, who chaired a press conference where Dr. Brinton presented highlights of DISRUPT CAD, declared lithoplasty is “in my mind a real breakthrough, not only for coronary disease but also for PAD.”
Is it possible that stand-alone lithoplasty could reduce the need for multiple stents in longer coronary lesions, instead making possible more focal stenting? asked Dr. Cremonesi of Maria Cecilia Hospital in Cotignola, Italy.
That’s one of several possibilities worthy of future investigation, Dr. Brinton replied. Lithoplasty might also facilitate the results obtainable with bioresorbable coronary scaffolds or drug-coated balloons, he added.
He noted that as cofounder of and a consultant to Shockwave Medical, he has a sizable financial involvement with the company.
PARIS – A novel therapeutic ultrasound-based technology known as lithoplasty is turning heads in interventional cardiology and vascular medicine because it addresses the bane of interventionalists’ existence: complex, heavily calcified coronary and peripheral artery lesions.
“Calcification is something we deal with every day in interventional cardiology. It makes the procedures more expensive, longer, and in fact several recent studies have shown that the complication rate for calcified lesions is higher than for any other lesion subtype. Calcification is the next big thing that we’re trying to take on in interventional cardiology,” Todd J. Brinton, MD, observed at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
At EuroPCR, he presented the results of DISRUPT CAD, a seven-center study in which 60 patients with heavily calcified coronary lesions underwent lithoplasty in order to facilitate stent placement. The study met all of its safety and performance endpoints. As a result, the week prior to EuroPCR the European regulatory agency granted marketing approval for Shockwave Medical’s coronary lithoplasty system; the indication is for coronary vessel preparation prior to stenting. A large phase III U.S. trial aimed at gaining FDA approval is planned.
Moreover, on the basis of the earlier favorable DISRUPT PAD trial, lithoplasty has already been approved for treatment of peripheral artery disease (PAD) in Europe since late 2015 and by the FDA since September 2016. Now underway is DISRUPT PAD III, a large postmarketing randomized trial comparing lithoplasty with conventional balloon angioplasty in patients with heavily calcified PAD, added Dr. Brinton, an interventional cardiologist at Stanford (Calif.) University and cofounder of Shockwave Medical.
Lithoplasty is a potentially transformative technology which he described as “lithotripsy inside a balloon.” Lithotripsy has an established 30-year track record for the safe treatment of kidney stones. However, lithotripsy utilizes focused ultrasound, while lithoplasty relies upon circumferential unfocused therapeutic ultrasound delivered by miniaturized emitters placed inside a 12-mm intravascular balloon. The balloon is crossed to the target lesion, inflated to a modest pressure of 4 atmospheres, then the operator delivers lithoplasty pulses lasting over 1 microsec in duration at a rate of 1/sec for 10 seconds in order to fracture the thick intramedial calcium plaque, allowing the lesion to open up and thereby normalize vessel compliance.
“Once you’ve cracked the calcium you can easily dilate the lesion. It’s the calcium that’s restricting the ability to dilate. The real fundamental need here is to maximize acute gain to get really good stent apposition. We’re trying to get expansion,” the cardiologist explained.
That was readily achieved in the DISRUPT CAD study. The 60 participants had reference vessel diameters of 2.5-4.0 mm, with an average target lesion length of 20 mm. The calcification was heavy, covering on average 270 degrees of the vessel circumference as measured by optical coherence tomography, with an average calcium thickness of 0.97 mm and a calcified segment length of 22.3 mm.
The mean stent expansion was 112%. The minimum luminal diameter improved from 0.9 mm pretreatment to 2.6 mm post treatment, for an acute gain of 1.7 mm. The amount of acute gain was similar across the full range of vessel diameters.
The mean diameter stenosis went from 68% pretreatment to 13% post-treatment.
The primary safety endpoint was the 30-day rate of MACE, defined as cardiac death, MI, or target vessel revascularization. The rate was 5%, consisting of 3 patients with mild non–Q-wave MI defined by creatine kinase–MB elevations more than three times the upper limit of normal. The 6-month MACE rate was 8.5%, which included the three non–Q-wave MIs plus two cardiac deaths not related to the procedure or technology.
Final angiographic results adjudicated in a central core laboratory showed no perforations, abrupt closures, slow or no reflow events, or residual dissections. These are complications commonly seen with debulking devices such as rotational or orbital atherectomy, Dr. Brinton noted.
The primary performance endpoint in DISRUPT CAD was clinical success, defined as a residual stenosis of less than 50% post PCI with no in-hospital MACE. This was achieved in 57 of 60 patients, or 95%. The device was successfully delivered to the target lesion with subsequent performance of lithoplasty in 59 of 60 patients. An even more flexible and deliverable device will be released in the coming year, according to the cardiologist.
“I’d say the take-home is that the disease has changed,” Dr. Brinton commented. “It’s not the same disease that we had when Gruentzig did his first balloon angioplasty. These lesions are more calcified, more complex, yet for the most part we use the same balloon we’ve been using for the last 40 years. So lithoplasty is really an attempt to modernize the therapy in a new patient subset we now take care of who are much more complicated than the patients we originally took care of.”
“The reality is, we’re having difficulty taking care of these patients. For myself as an interventionalist, it’s not uncommon to look around the table and see a massive amount of tools when we’re doing these complex cases. Lithoplasty is intended to bring the simplicity. I would say it’s not necessarily to make the best operators better, it’s to bring all operators up to the ability to take on these complex lesions that are now usually reserved for high-volume centers that can do debulking,” he added.
Session cochair David R. Holmes Jr., MD, of the Mayo Clinic in Rochester, Minn., pronounced lithoplasty “tremendously exciting.” He and the other panelists focused on questions of safety and potential collateral damage: Where does the calcified debris go? What are the effects of the unfocused sonic pressure waves on noncalcified plaque? How hot does the vessel get?
Dr. Brinton replied that thick calcium plaque is located mostly in the medial vessel wall and stays there after fracturing. That’s why distal embolization wasn’t an issue in DISRUPT CAD. In animal studies, even at 20 times the energy dose used in clinical practice, lithoplasty had no effect on softer, noncalcified plaque or normal tissue. Vessel temperature increases by about 1.2 degrees C during lithoplasty, which isn’t sufficient to cause injury or drive restenosis.
Elsewhere at EuroPCR, Alberto Cremonesi, MD, who chaired a press conference where Dr. Brinton presented highlights of DISRUPT CAD, declared lithoplasty is “in my mind a real breakthrough, not only for coronary disease but also for PAD.”
Is it possible that stand-alone lithoplasty could reduce the need for multiple stents in longer coronary lesions, instead making possible more focal stenting? asked Dr. Cremonesi of Maria Cecilia Hospital in Cotignola, Italy.
That’s one of several possibilities worthy of future investigation, Dr. Brinton replied. Lithoplasty might also facilitate the results obtainable with bioresorbable coronary scaffolds or drug-coated balloons, he added.
He noted that as cofounder of and a consultant to Shockwave Medical, he has a sizable financial involvement with the company.
AT EUROPCR
Key clinical point:
Major finding: Lithoplasty of heavily calcified coronary lesions improved the minimum luminal diameter from 0.9 mm pretreatment to 2.6 mm post-treatment, for an immediate gain of 1.7 mm prior to stent placement.
Data source: This study featured 6-month follow-up of 60 patients with heavily calcified coronary lesions who underwent lithoplasty followed by stenting.
Disclosures: The DISRUPT CAD study was sponsored by Shockwave Medical, which is developing lithoplasty. The presenter cofounded the company.
Amplatzer devices outperform oral anticoagulation in atrial fib
PARIS – Percutaneous left atrial appendage closure with an Amplatzer device in patients with nonvalvular atrial fibrillation was associated with significantly lower rates of all-cause and cardiovascular mortality, compared with oral anticoagulation, in a large propensity score–matched observational registry study.
Left atrial appendage closure (LAAC) also bested oral anticoagulation (OAC) with warfarin or a novel oral anticoagulant (NOAC) in terms of net clinical benefit on the basis of the device therapy’s greater protection against stroke and systemic embolism coupled with a trend, albeit not statistically significant, for fewer bleeding events, Steffen Gloekler, MD, reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
The Watchman LAAC device, commercially available both in Europe and the United States, has previously been shown to be superior to OAC in terms of efficacy and noninferior regarding safety. But there have been no randomized trials of an Amplatzer device versus OAC. This lack of data was the impetus for Dr. Gloekler and his coinvestigators to create a meticulously propensity-matched observational registry.
Five hundred consecutive patients with AF who received an Amplatzer Cardiac Plug or its second-generation version, the Amplatzer Amulet, during 2009-2014 were tightly matched to an equal number of AF patients on OAC based on age, sex, body mass index, left ventricular ejection fraction, renal function, coronary artery disease status, hemoglobin level, CHA2DS2-VASc score, and HAS-BLED score. During a mean 2.7 years, or 2,645 patient-years, of follow-up, the composite primary efficacy endpoint, composed of stroke, systemic embolism, and cardiovascular or unexplained death occurred in 5.6% of the LAAC group, compared with 7.8% of controls in the OAC arm, for a statistically significant 30% relative risk reduction. Disabling stroke occurred in 0.7% of Amplatzer patients versus 1.5% of controls. The ischemic stroke rate was 1.5% in the device therapy group and 2% in the OAC arm.
All-cause mortality occurred in 8.3% of Amplatzer patients and 11.6% of the OAC group, for a 28% relative risk reduction. The cardiovascular death rate was 4% in the Amplatzer group, compared with 6.5% of controls, for a 36% risk reduction.
The composite safety endpoint, comprising all major procedural adverse events and major or life-threatening bleeding during follow-up, occurred in 3.6% of the Amplatzer group and 4.6% of the OAC group, for a 20% relative risk reduction that is not significant at this point because of the low number of events. Major, life-threatening, or fatal bleeding occurred in 2% of Amplatzer recipients versus 5.5% of controls, added Dr. Gloekler of University Hospital in Bern, Switzerland.
The net clinical benefit, a composite of death, bleeding, or stroke, occurred in 8.1% of the Amplatzer group, compared with 10.9% of controls, for a significant 24% reduction in relative risk in favor of device therapy.
Of note, at 2.7 years of follow-up only 55% of the OAC group were still taking an anticoagulant: 38% of the original 500 patients were on warfarin, and 17% were taking a NOAC. At that point, 8% of the Amplatzer group were on any anticoagulation therapy.
Discussion of the study focused on that low rate of medication adherence in the OAC arm. Dr. Gloekler’s response was that, after looking at the literature, he was no longer surprised by the finding that only 55% of the control group were on OAC at follow-up.
“If you look in the literature, that’s exactly the real-world adherence for OACs. Even in all four certification trials for the NOACs, the rate of discontinuation was 30% after 2 years – and these were controlled studies. Ours was observational, and it depicts a good deal of the problem with any OAC in my eyes,” Dr. Gloekler said.
Patients on warfarin in the real-world Amplatzer registry study spent on average a mere 30% of time in the therapeutic international normalized ratio range of 2-3.
“That means 70% of the time patients are higher and have an increased bleeding risk or they are lower and don’t have adequate stroke protection,” he noted.
This prompted one observer to comment, “We either have to do a better job in our clinics with OAC or we have to occlude more appendages.”
A large pivotal U.S. trial aimed at winning FDA approval for the Amplatzer Amulet for LAAC is underway. Patients with AF are being randomized to the approved Watchman or investigational Amulet at roughly 100 U.S. and 50 foreign sites.
Dr. Gloekler reported receiving research funds for the registry from the Swiss Heart Foundation and Abbott.
PARIS – Percutaneous left atrial appendage closure with an Amplatzer device in patients with nonvalvular atrial fibrillation was associated with significantly lower rates of all-cause and cardiovascular mortality, compared with oral anticoagulation, in a large propensity score–matched observational registry study.
Left atrial appendage closure (LAAC) also bested oral anticoagulation (OAC) with warfarin or a novel oral anticoagulant (NOAC) in terms of net clinical benefit on the basis of the device therapy’s greater protection against stroke and systemic embolism coupled with a trend, albeit not statistically significant, for fewer bleeding events, Steffen Gloekler, MD, reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
The Watchman LAAC device, commercially available both in Europe and the United States, has previously been shown to be superior to OAC in terms of efficacy and noninferior regarding safety. But there have been no randomized trials of an Amplatzer device versus OAC. This lack of data was the impetus for Dr. Gloekler and his coinvestigators to create a meticulously propensity-matched observational registry.
Five hundred consecutive patients with AF who received an Amplatzer Cardiac Plug or its second-generation version, the Amplatzer Amulet, during 2009-2014 were tightly matched to an equal number of AF patients on OAC based on age, sex, body mass index, left ventricular ejection fraction, renal function, coronary artery disease status, hemoglobin level, CHA2DS2-VASc score, and HAS-BLED score. During a mean 2.7 years, or 2,645 patient-years, of follow-up, the composite primary efficacy endpoint, composed of stroke, systemic embolism, and cardiovascular or unexplained death occurred in 5.6% of the LAAC group, compared with 7.8% of controls in the OAC arm, for a statistically significant 30% relative risk reduction. Disabling stroke occurred in 0.7% of Amplatzer patients versus 1.5% of controls. The ischemic stroke rate was 1.5% in the device therapy group and 2% in the OAC arm.
All-cause mortality occurred in 8.3% of Amplatzer patients and 11.6% of the OAC group, for a 28% relative risk reduction. The cardiovascular death rate was 4% in the Amplatzer group, compared with 6.5% of controls, for a 36% risk reduction.
The composite safety endpoint, comprising all major procedural adverse events and major or life-threatening bleeding during follow-up, occurred in 3.6% of the Amplatzer group and 4.6% of the OAC group, for a 20% relative risk reduction that is not significant at this point because of the low number of events. Major, life-threatening, or fatal bleeding occurred in 2% of Amplatzer recipients versus 5.5% of controls, added Dr. Gloekler of University Hospital in Bern, Switzerland.
The net clinical benefit, a composite of death, bleeding, or stroke, occurred in 8.1% of the Amplatzer group, compared with 10.9% of controls, for a significant 24% reduction in relative risk in favor of device therapy.
Of note, at 2.7 years of follow-up only 55% of the OAC group were still taking an anticoagulant: 38% of the original 500 patients were on warfarin, and 17% were taking a NOAC. At that point, 8% of the Amplatzer group were on any anticoagulation therapy.
Discussion of the study focused on that low rate of medication adherence in the OAC arm. Dr. Gloekler’s response was that, after looking at the literature, he was no longer surprised by the finding that only 55% of the control group were on OAC at follow-up.
“If you look in the literature, that’s exactly the real-world adherence for OACs. Even in all four certification trials for the NOACs, the rate of discontinuation was 30% after 2 years – and these were controlled studies. Ours was observational, and it depicts a good deal of the problem with any OAC in my eyes,” Dr. Gloekler said.
Patients on warfarin in the real-world Amplatzer registry study spent on average a mere 30% of time in the therapeutic international normalized ratio range of 2-3.
“That means 70% of the time patients are higher and have an increased bleeding risk or they are lower and don’t have adequate stroke protection,” he noted.
This prompted one observer to comment, “We either have to do a better job in our clinics with OAC or we have to occlude more appendages.”
A large pivotal U.S. trial aimed at winning FDA approval for the Amplatzer Amulet for LAAC is underway. Patients with AF are being randomized to the approved Watchman or investigational Amulet at roughly 100 U.S. and 50 foreign sites.
Dr. Gloekler reported receiving research funds for the registry from the Swiss Heart Foundation and Abbott.
PARIS – Percutaneous left atrial appendage closure with an Amplatzer device in patients with nonvalvular atrial fibrillation was associated with significantly lower rates of all-cause and cardiovascular mortality, compared with oral anticoagulation, in a large propensity score–matched observational registry study.
Left atrial appendage closure (LAAC) also bested oral anticoagulation (OAC) with warfarin or a novel oral anticoagulant (NOAC) in terms of net clinical benefit on the basis of the device therapy’s greater protection against stroke and systemic embolism coupled with a trend, albeit not statistically significant, for fewer bleeding events, Steffen Gloekler, MD, reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
The Watchman LAAC device, commercially available both in Europe and the United States, has previously been shown to be superior to OAC in terms of efficacy and noninferior regarding safety. But there have been no randomized trials of an Amplatzer device versus OAC. This lack of data was the impetus for Dr. Gloekler and his coinvestigators to create a meticulously propensity-matched observational registry.
Five hundred consecutive patients with AF who received an Amplatzer Cardiac Plug or its second-generation version, the Amplatzer Amulet, during 2009-2014 were tightly matched to an equal number of AF patients on OAC based on age, sex, body mass index, left ventricular ejection fraction, renal function, coronary artery disease status, hemoglobin level, CHA2DS2-VASc score, and HAS-BLED score. During a mean 2.7 years, or 2,645 patient-years, of follow-up, the composite primary efficacy endpoint, composed of stroke, systemic embolism, and cardiovascular or unexplained death occurred in 5.6% of the LAAC group, compared with 7.8% of controls in the OAC arm, for a statistically significant 30% relative risk reduction. Disabling stroke occurred in 0.7% of Amplatzer patients versus 1.5% of controls. The ischemic stroke rate was 1.5% in the device therapy group and 2% in the OAC arm.
All-cause mortality occurred in 8.3% of Amplatzer patients and 11.6% of the OAC group, for a 28% relative risk reduction. The cardiovascular death rate was 4% in the Amplatzer group, compared with 6.5% of controls, for a 36% risk reduction.
The composite safety endpoint, comprising all major procedural adverse events and major or life-threatening bleeding during follow-up, occurred in 3.6% of the Amplatzer group and 4.6% of the OAC group, for a 20% relative risk reduction that is not significant at this point because of the low number of events. Major, life-threatening, or fatal bleeding occurred in 2% of Amplatzer recipients versus 5.5% of controls, added Dr. Gloekler of University Hospital in Bern, Switzerland.
The net clinical benefit, a composite of death, bleeding, or stroke, occurred in 8.1% of the Amplatzer group, compared with 10.9% of controls, for a significant 24% reduction in relative risk in favor of device therapy.
Of note, at 2.7 years of follow-up only 55% of the OAC group were still taking an anticoagulant: 38% of the original 500 patients were on warfarin, and 17% were taking a NOAC. At that point, 8% of the Amplatzer group were on any anticoagulation therapy.
Discussion of the study focused on that low rate of medication adherence in the OAC arm. Dr. Gloekler’s response was that, after looking at the literature, he was no longer surprised by the finding that only 55% of the control group were on OAC at follow-up.
“If you look in the literature, that’s exactly the real-world adherence for OACs. Even in all four certification trials for the NOACs, the rate of discontinuation was 30% after 2 years – and these were controlled studies. Ours was observational, and it depicts a good deal of the problem with any OAC in my eyes,” Dr. Gloekler said.
Patients on warfarin in the real-world Amplatzer registry study spent on average a mere 30% of time in the therapeutic international normalized ratio range of 2-3.
“That means 70% of the time patients are higher and have an increased bleeding risk or they are lower and don’t have adequate stroke protection,” he noted.
This prompted one observer to comment, “We either have to do a better job in our clinics with OAC or we have to occlude more appendages.”
A large pivotal U.S. trial aimed at winning FDA approval for the Amplatzer Amulet for LAAC is underway. Patients with AF are being randomized to the approved Watchman or investigational Amulet at roughly 100 U.S. and 50 foreign sites.
Dr. Gloekler reported receiving research funds for the registry from the Swiss Heart Foundation and Abbott.
AT EUROPCR
Key clinical point:
Major finding: The primary composite efficacy endpoint of stroke, systemic embolism, or cardiovascular or unexplained death during a mean 2.7 years of follow-up occurred in 5.6% of Amplatzer device recipients, a 30% reduction, compared with the 7.8% rate in the oral anticoagulation group.
Data source: This observational registry included 500 patients with atrial fibrillation who received an Amplatzer left atrial appendage closure device and an equal number of carefully matched AF patients on oral anticoagulation.
Disclosures: The study presenter reported receiving research funds for the registry from the Swiss Heart Foundation and Abbott.
Bad news keeps piling up for Absorb coronary scaffold
PARIS – Device thrombosis occurred nearly four times more frequently in recipients of the Absorb everolimus-eluting bioresorbable vascular scaffold than with the Xience everolimus-eluting metallic stent during 2 years of prospective follow-up in the randomized AIDA trial.
AIDA (the Amsterdam Investigator-Initiated Absorb Strategy All-Comers Trial) was the first randomized trial designed to compare the Absorb scaffold to a drug-eluting metallic stent in a broad patient population reflecting routine real-world clinical practice. The disturbing AIDA finding follows upon earlier serious concerns raised regarding an increased risk of scaffold thrombosis – and the particularly worrisome complication of late thrombosis – in the ABSORB Japan and ABSORB II trials, Joanna J. Wykrzykowska, MD, reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
The device was approved by the Food and Drug Administration in July 2016. In March 2017 the agency issued a safety alert regarding the Absorb scaffold after release of the 2-year data from the 2,008-patient ABSORB III trial showing a significantly higher rate of target-lesion failure than with the Xience stent. Both devices are marketed by Abbott Vascular.
AIDA was a single-blind multicenter Dutch trial that randomized 1,845 patients undergoing PCI, 55% of whom presented with acute coronary syndrome and 26% of whom had ST-elevation MI. The primary endpoint was target vessel failure, a composite of cardiac death, target vessel MI, or target vessel revascularization. The 2-year cumulative rate did not differ significantly between the two study arms: 11.7% in the scaffold group and 10.7% in the metallic stent recipients.
However, definite or probable device thrombosis occurred in 3.5% of the scaffold group compared with 0.9% of metallic stent recipients, for a highly significant 3.9-fold increased risk. This was associated with a significantly increased 2-year cumulative risk of MI: 5.5% versus 3.2%.
On the basis of this unsettling finding, coupled with the fact that ABSORB II investigators did not find any instance of very late scaffold thrombosis among 63 patients who remained on dual-antiplatelet therapy (DAPT) continuously for up to 3 years, Dr. Wykrzykowska and her coinvestigators have informed AIDA participants of their treatment assignment. They have also recommended that the Absorb recipients go on extended DAPT, even though there is no high-grade evidence as yet that this will prevent late scaffold thrombosis or that the drug-induced increased bleeding risk of prolonged DAPT might cancel or perhaps even outweigh the potential protection against device thrombosis.
On top of all this, implantation of the scaffold entails a longer procedure time and a greater volume of contrast material.
Discussant Mahmoud Hashemian, MD, observed that while bioresorbable vascular scaffolds are “physiologically ideal” because, unlike metallic stents, theoretically they leave no permanent implant to impede vasomotion and serve as a nidus for neoatherosclerosis, to date they have shown no real-world benefits over current-generation drug-eluting metallic stents, but only disadvantages.
“This doesn’t mean we have to feel hopeless. I’m not hopeless at all,” said Dr. Hashemian, an interventional cardiologist at Day General Hospital in Tehran. “I’m sure this [bioresorbable scaffolds] will be the future of our stents. But it needs more work. The company tells me they are going to launch a newer one, maybe next year, with thinner struts and more expandability.”
Asked about the likely mechanism of prolonged thrombosis risk with Absorb, Dr. Wykrzykowska was quick to say no one really knows at this point.
“Technique [predilation at a 1:1 balloon-to-artery ratio with an appropriately sized balloon] can obviously improve things in the short term for early events, but I don’t think we understand the biology of late events. We don’t understand the interaction between the device and the vessel. It’s extremely complex,” she said.
AIDA was funded by an unrestricted educational grant from Abbott Vascular. Dr. Wykrzykowska reported receiving consulting and lecture fees from the company.
PARIS – Device thrombosis occurred nearly four times more frequently in recipients of the Absorb everolimus-eluting bioresorbable vascular scaffold than with the Xience everolimus-eluting metallic stent during 2 years of prospective follow-up in the randomized AIDA trial.
AIDA (the Amsterdam Investigator-Initiated Absorb Strategy All-Comers Trial) was the first randomized trial designed to compare the Absorb scaffold to a drug-eluting metallic stent in a broad patient population reflecting routine real-world clinical practice. The disturbing AIDA finding follows upon earlier serious concerns raised regarding an increased risk of scaffold thrombosis – and the particularly worrisome complication of late thrombosis – in the ABSORB Japan and ABSORB II trials, Joanna J. Wykrzykowska, MD, reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
The device was approved by the Food and Drug Administration in July 2016. In March 2017 the agency issued a safety alert regarding the Absorb scaffold after release of the 2-year data from the 2,008-patient ABSORB III trial showing a significantly higher rate of target-lesion failure than with the Xience stent. Both devices are marketed by Abbott Vascular.
AIDA was a single-blind multicenter Dutch trial that randomized 1,845 patients undergoing PCI, 55% of whom presented with acute coronary syndrome and 26% of whom had ST-elevation MI. The primary endpoint was target vessel failure, a composite of cardiac death, target vessel MI, or target vessel revascularization. The 2-year cumulative rate did not differ significantly between the two study arms: 11.7% in the scaffold group and 10.7% in the metallic stent recipients.
However, definite or probable device thrombosis occurred in 3.5% of the scaffold group compared with 0.9% of metallic stent recipients, for a highly significant 3.9-fold increased risk. This was associated with a significantly increased 2-year cumulative risk of MI: 5.5% versus 3.2%.
On the basis of this unsettling finding, coupled with the fact that ABSORB II investigators did not find any instance of very late scaffold thrombosis among 63 patients who remained on dual-antiplatelet therapy (DAPT) continuously for up to 3 years, Dr. Wykrzykowska and her coinvestigators have informed AIDA participants of their treatment assignment. They have also recommended that the Absorb recipients go on extended DAPT, even though there is no high-grade evidence as yet that this will prevent late scaffold thrombosis or that the drug-induced increased bleeding risk of prolonged DAPT might cancel or perhaps even outweigh the potential protection against device thrombosis.
On top of all this, implantation of the scaffold entails a longer procedure time and a greater volume of contrast material.
Discussant Mahmoud Hashemian, MD, observed that while bioresorbable vascular scaffolds are “physiologically ideal” because, unlike metallic stents, theoretically they leave no permanent implant to impede vasomotion and serve as a nidus for neoatherosclerosis, to date they have shown no real-world benefits over current-generation drug-eluting metallic stents, but only disadvantages.
“This doesn’t mean we have to feel hopeless. I’m not hopeless at all,” said Dr. Hashemian, an interventional cardiologist at Day General Hospital in Tehran. “I’m sure this [bioresorbable scaffolds] will be the future of our stents. But it needs more work. The company tells me they are going to launch a newer one, maybe next year, with thinner struts and more expandability.”
Asked about the likely mechanism of prolonged thrombosis risk with Absorb, Dr. Wykrzykowska was quick to say no one really knows at this point.
“Technique [predilation at a 1:1 balloon-to-artery ratio with an appropriately sized balloon] can obviously improve things in the short term for early events, but I don’t think we understand the biology of late events. We don’t understand the interaction between the device and the vessel. It’s extremely complex,” she said.
AIDA was funded by an unrestricted educational grant from Abbott Vascular. Dr. Wykrzykowska reported receiving consulting and lecture fees from the company.
PARIS – Device thrombosis occurred nearly four times more frequently in recipients of the Absorb everolimus-eluting bioresorbable vascular scaffold than with the Xience everolimus-eluting metallic stent during 2 years of prospective follow-up in the randomized AIDA trial.
AIDA (the Amsterdam Investigator-Initiated Absorb Strategy All-Comers Trial) was the first randomized trial designed to compare the Absorb scaffold to a drug-eluting metallic stent in a broad patient population reflecting routine real-world clinical practice. The disturbing AIDA finding follows upon earlier serious concerns raised regarding an increased risk of scaffold thrombosis – and the particularly worrisome complication of late thrombosis – in the ABSORB Japan and ABSORB II trials, Joanna J. Wykrzykowska, MD, reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
The device was approved by the Food and Drug Administration in July 2016. In March 2017 the agency issued a safety alert regarding the Absorb scaffold after release of the 2-year data from the 2,008-patient ABSORB III trial showing a significantly higher rate of target-lesion failure than with the Xience stent. Both devices are marketed by Abbott Vascular.
AIDA was a single-blind multicenter Dutch trial that randomized 1,845 patients undergoing PCI, 55% of whom presented with acute coronary syndrome and 26% of whom had ST-elevation MI. The primary endpoint was target vessel failure, a composite of cardiac death, target vessel MI, or target vessel revascularization. The 2-year cumulative rate did not differ significantly between the two study arms: 11.7% in the scaffold group and 10.7% in the metallic stent recipients.
However, definite or probable device thrombosis occurred in 3.5% of the scaffold group compared with 0.9% of metallic stent recipients, for a highly significant 3.9-fold increased risk. This was associated with a significantly increased 2-year cumulative risk of MI: 5.5% versus 3.2%.
On the basis of this unsettling finding, coupled with the fact that ABSORB II investigators did not find any instance of very late scaffold thrombosis among 63 patients who remained on dual-antiplatelet therapy (DAPT) continuously for up to 3 years, Dr. Wykrzykowska and her coinvestigators have informed AIDA participants of their treatment assignment. They have also recommended that the Absorb recipients go on extended DAPT, even though there is no high-grade evidence as yet that this will prevent late scaffold thrombosis or that the drug-induced increased bleeding risk of prolonged DAPT might cancel or perhaps even outweigh the potential protection against device thrombosis.
On top of all this, implantation of the scaffold entails a longer procedure time and a greater volume of contrast material.
Discussant Mahmoud Hashemian, MD, observed that while bioresorbable vascular scaffolds are “physiologically ideal” because, unlike metallic stents, theoretically they leave no permanent implant to impede vasomotion and serve as a nidus for neoatherosclerosis, to date they have shown no real-world benefits over current-generation drug-eluting metallic stents, but only disadvantages.
“This doesn’t mean we have to feel hopeless. I’m not hopeless at all,” said Dr. Hashemian, an interventional cardiologist at Day General Hospital in Tehran. “I’m sure this [bioresorbable scaffolds] will be the future of our stents. But it needs more work. The company tells me they are going to launch a newer one, maybe next year, with thinner struts and more expandability.”
Asked about the likely mechanism of prolonged thrombosis risk with Absorb, Dr. Wykrzykowska was quick to say no one really knows at this point.
“Technique [predilation at a 1:1 balloon-to-artery ratio with an appropriately sized balloon] can obviously improve things in the short term for early events, but I don’t think we understand the biology of late events. We don’t understand the interaction between the device and the vessel. It’s extremely complex,” she said.
AIDA was funded by an unrestricted educational grant from Abbott Vascular. Dr. Wykrzykowska reported receiving consulting and lecture fees from the company.
AT EUROPCR
Key clinical point:
Major finding: During 2 years of prospective follow-up, definite or probable device thrombosis occurred in 3.5% of recipients of a bioresorbable vascular scaffold, compared with 0.9% of metallic stent recipients, for a highly significant 3.9-fold increased risk.
Data source: AIDA, a single-blind multicenter Dutch trial that randomized a broadly representative group of 1,845 patients undergoing PCI to the Absorb bioresorbable vascular scaffold or the Xience everolimus-eluting metallic stent.
Disclosures: The AIDA study was funded by an unrestricted educational grant from Abbott Vascular. The presenter reported receiving consulting and lecture fees from the company.
Do sleep interventions prevent atrial fibrillation?
WASHINGTON – If patients have sleep disordered breathing with obstructive sleep apnea, will its treatment have cardiovascular disease benefits, especially in terms of the incidence or severity of atrial fibrillation?
Observational evidence suggests that apnea interventions may help these patients, but no clear case yet exists to prove that a breathing intervention works, experts say, and, as a result, U.S. practice is mixed when it comes to using treatment for obstructive sleep apnea (OSA), specifically continuous positive airway pressure (CPAP), to prevent or treat atrial fibrillation.
“Only a very small number of patients with atrial fibrillation undergo a sleep study,” he said in an interview. “Before I’d send my mother for atrial fibrillation ablation, I would first look for sleep disordered breathing [SDB],” but this generally isn’t happening routinely. Patients with other types of cardiovascular disease who could potentially benefit from sleep disordered breathing diagnosis and treatment are those with hypertension, especially patients who don’t fully respond to three or more antihypertensive drugs and patients with heart failure with preserved ejection fraction, he added.
Dr. Oldenburg also echoed Dr. Mehra in saying that the evidence supporting this approach for managing atrial fibrillation is less than conclusive.
“We need more precise phenotyping of patients” to better focus on patients with cardiovascular disease and sleep disordered breathing who clearly benefit from CPAP intervention, he said.
Results from the Sleep Apnea Cardiovascular Endpoints (SAVE) trial, reported in September 2016, especially tarnished the notion that treating sleep disordered breathing in patients with various cardiovascular diseases can help avoid future cardiovascular events. The multicenter trial enrolled 2,717 adults with moderate to severe obstructive sleep apnea and cardiovascular disease to receive either CPAP plus optimal routine care or optimal routine care only. After an average follow-up of close to 4 years, the patients treated with CPAP showed no benefit in terms of reduced cardiovascular events (N Engl J Med. 2016 Sept 8;375[10]:919-31).
An editorial that ran with this report suggested that the neutral outcome may have occurred because the average nightly duration of CPAP that patients in the trial self administered was just over 3 hours, arguably an inadequate dose. Other possible reasons for the lack of benefit include the time during their sleep cycle when patients administered CPAP (at the start of sleep rather than later) and that CPAP may have a reduced ability to avert new cardiovascular events in patients with established cardiovascular disease (N Engl J Med. 2016 Sept 8;375[8]:994-6).
Regardless of the reasons, the SAVE results, coupled with the neutral results and suggestion of harm from using adaptive servo-ventilation in patients with heart failure with reduced ejection fraction and central sleep apnea in the SERVE-HF trial (N Engl J Med. 2015 Sept 17;373[12]:1095-105), have thrust the management of SDB in patients with cardiovascular disease back to the point where SDB interventions have no well-proven indications for cardiovascular disease patients.
“With the SERVE-HF and SAVE trials not showing benefit, we now have equipoise” for using or not using SDB interventions in these patients, Dr. Mehra said. “It’s not clear that treating OSA improves outcomes. That allows us to randomize patients to a control placebo arm” in future trials.
An important issue in the failure to clearly establish a role for treating OSA in patients with atrial fibrillation or other cardiovascular diseases may have been over reliance on the apnea-hypopnea index (AHI) as the arbiter of OSA severity, Dr. Oldenburg said. “Maybe there are parameters to look at aside from AHI, perhaps hypoxemia burden or desaturation time. AHI is not the whole truth; we need to look at other parameters. AHI may not be the correct metric to look at in patients with various cardiovascular diseases.”
Her analysis also showed that patients with at least 10 minutes of sleep time with an oxygen saturation rate of 90% or less had a 64% increased rate of later atrial fibrillation hospitalizations, compared with those with fewer than 10 minutes spent in this state. Nearly a quarter of the patients studied fell into this category.
“Nocturnal oxygen desaturation may be stronger than AHI for predicting atrial fibrillation development,” Dr. Kendzerska concluded. “The severity of OSA-related intermittent hypoxia may be more important than sleep fragmentation in the development of atrial fibrillation. These findings support a relationship between OSA, chronic nocturnal hypoxemia, and new onset atrial fibrillation.”
However, using oxygen desaturation instead of AHI to gauge the severity of OSA won’t solve all the challenges that sleep researchers currently face in trying to determine the efficacy of breathing interventions to prevent or treat cardiovascular disease. In the neutral SAVE trial, researchers used nocturnal oxygen saturation levels to select patients with clinically meaningful OSA.
Dr. Mehra and Dr. Kendzerska had no disclosures. Dr. Oldenburg has received consultant fees, honoraria, and/or research support from ResMed, Respicardia, and Weinmann.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
This article was updated on 7/10/17.
WASHINGTON – If patients have sleep disordered breathing with obstructive sleep apnea, will its treatment have cardiovascular disease benefits, especially in terms of the incidence or severity of atrial fibrillation?
Observational evidence suggests that apnea interventions may help these patients, but no clear case yet exists to prove that a breathing intervention works, experts say, and, as a result, U.S. practice is mixed when it comes to using treatment for obstructive sleep apnea (OSA), specifically continuous positive airway pressure (CPAP), to prevent or treat atrial fibrillation.
“Only a very small number of patients with atrial fibrillation undergo a sleep study,” he said in an interview. “Before I’d send my mother for atrial fibrillation ablation, I would first look for sleep disordered breathing [SDB],” but this generally isn’t happening routinely. Patients with other types of cardiovascular disease who could potentially benefit from sleep disordered breathing diagnosis and treatment are those with hypertension, especially patients who don’t fully respond to three or more antihypertensive drugs and patients with heart failure with preserved ejection fraction, he added.
Dr. Oldenburg also echoed Dr. Mehra in saying that the evidence supporting this approach for managing atrial fibrillation is less than conclusive.
“We need more precise phenotyping of patients” to better focus on patients with cardiovascular disease and sleep disordered breathing who clearly benefit from CPAP intervention, he said.
Results from the Sleep Apnea Cardiovascular Endpoints (SAVE) trial, reported in September 2016, especially tarnished the notion that treating sleep disordered breathing in patients with various cardiovascular diseases can help avoid future cardiovascular events. The multicenter trial enrolled 2,717 adults with moderate to severe obstructive sleep apnea and cardiovascular disease to receive either CPAP plus optimal routine care or optimal routine care only. After an average follow-up of close to 4 years, the patients treated with CPAP showed no benefit in terms of reduced cardiovascular events (N Engl J Med. 2016 Sept 8;375[10]:919-31).
An editorial that ran with this report suggested that the neutral outcome may have occurred because the average nightly duration of CPAP that patients in the trial self administered was just over 3 hours, arguably an inadequate dose. Other possible reasons for the lack of benefit include the time during their sleep cycle when patients administered CPAP (at the start of sleep rather than later) and that CPAP may have a reduced ability to avert new cardiovascular events in patients with established cardiovascular disease (N Engl J Med. 2016 Sept 8;375[8]:994-6).
Regardless of the reasons, the SAVE results, coupled with the neutral results and suggestion of harm from using adaptive servo-ventilation in patients with heart failure with reduced ejection fraction and central sleep apnea in the SERVE-HF trial (N Engl J Med. 2015 Sept 17;373[12]:1095-105), have thrust the management of SDB in patients with cardiovascular disease back to the point where SDB interventions have no well-proven indications for cardiovascular disease patients.
“With the SERVE-HF and SAVE trials not showing benefit, we now have equipoise” for using or not using SDB interventions in these patients, Dr. Mehra said. “It’s not clear that treating OSA improves outcomes. That allows us to randomize patients to a control placebo arm” in future trials.
An important issue in the failure to clearly establish a role for treating OSA in patients with atrial fibrillation or other cardiovascular diseases may have been over reliance on the apnea-hypopnea index (AHI) as the arbiter of OSA severity, Dr. Oldenburg said. “Maybe there are parameters to look at aside from AHI, perhaps hypoxemia burden or desaturation time. AHI is not the whole truth; we need to look at other parameters. AHI may not be the correct metric to look at in patients with various cardiovascular diseases.”
Her analysis also showed that patients with at least 10 minutes of sleep time with an oxygen saturation rate of 90% or less had a 64% increased rate of later atrial fibrillation hospitalizations, compared with those with fewer than 10 minutes spent in this state. Nearly a quarter of the patients studied fell into this category.
“Nocturnal oxygen desaturation may be stronger than AHI for predicting atrial fibrillation development,” Dr. Kendzerska concluded. “The severity of OSA-related intermittent hypoxia may be more important than sleep fragmentation in the development of atrial fibrillation. These findings support a relationship between OSA, chronic nocturnal hypoxemia, and new onset atrial fibrillation.”
However, using oxygen desaturation instead of AHI to gauge the severity of OSA won’t solve all the challenges that sleep researchers currently face in trying to determine the efficacy of breathing interventions to prevent or treat cardiovascular disease. In the neutral SAVE trial, researchers used nocturnal oxygen saturation levels to select patients with clinically meaningful OSA.
Dr. Mehra and Dr. Kendzerska had no disclosures. Dr. Oldenburg has received consultant fees, honoraria, and/or research support from ResMed, Respicardia, and Weinmann.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
This article was updated on 7/10/17.
WASHINGTON – If patients have sleep disordered breathing with obstructive sleep apnea, will its treatment have cardiovascular disease benefits, especially in terms of the incidence or severity of atrial fibrillation?
Observational evidence suggests that apnea interventions may help these patients, but no clear case yet exists to prove that a breathing intervention works, experts say, and, as a result, U.S. practice is mixed when it comes to using treatment for obstructive sleep apnea (OSA), specifically continuous positive airway pressure (CPAP), to prevent or treat atrial fibrillation.
“Only a very small number of patients with atrial fibrillation undergo a sleep study,” he said in an interview. “Before I’d send my mother for atrial fibrillation ablation, I would first look for sleep disordered breathing [SDB],” but this generally isn’t happening routinely. Patients with other types of cardiovascular disease who could potentially benefit from sleep disordered breathing diagnosis and treatment are those with hypertension, especially patients who don’t fully respond to three or more antihypertensive drugs and patients with heart failure with preserved ejection fraction, he added.
Dr. Oldenburg also echoed Dr. Mehra in saying that the evidence supporting this approach for managing atrial fibrillation is less than conclusive.
“We need more precise phenotyping of patients” to better focus on patients with cardiovascular disease and sleep disordered breathing who clearly benefit from CPAP intervention, he said.
Results from the Sleep Apnea Cardiovascular Endpoints (SAVE) trial, reported in September 2016, especially tarnished the notion that treating sleep disordered breathing in patients with various cardiovascular diseases can help avoid future cardiovascular events. The multicenter trial enrolled 2,717 adults with moderate to severe obstructive sleep apnea and cardiovascular disease to receive either CPAP plus optimal routine care or optimal routine care only. After an average follow-up of close to 4 years, the patients treated with CPAP showed no benefit in terms of reduced cardiovascular events (N Engl J Med. 2016 Sept 8;375[10]:919-31).
An editorial that ran with this report suggested that the neutral outcome may have occurred because the average nightly duration of CPAP that patients in the trial self administered was just over 3 hours, arguably an inadequate dose. Other possible reasons for the lack of benefit include the time during their sleep cycle when patients administered CPAP (at the start of sleep rather than later) and that CPAP may have a reduced ability to avert new cardiovascular events in patients with established cardiovascular disease (N Engl J Med. 2016 Sept 8;375[8]:994-6).
Regardless of the reasons, the SAVE results, coupled with the neutral results and suggestion of harm from using adaptive servo-ventilation in patients with heart failure with reduced ejection fraction and central sleep apnea in the SERVE-HF trial (N Engl J Med. 2015 Sept 17;373[12]:1095-105), have thrust the management of SDB in patients with cardiovascular disease back to the point where SDB interventions have no well-proven indications for cardiovascular disease patients.
“With the SERVE-HF and SAVE trials not showing benefit, we now have equipoise” for using or not using SDB interventions in these patients, Dr. Mehra said. “It’s not clear that treating OSA improves outcomes. That allows us to randomize patients to a control placebo arm” in future trials.
An important issue in the failure to clearly establish a role for treating OSA in patients with atrial fibrillation or other cardiovascular diseases may have been over reliance on the apnea-hypopnea index (AHI) as the arbiter of OSA severity, Dr. Oldenburg said. “Maybe there are parameters to look at aside from AHI, perhaps hypoxemia burden or desaturation time. AHI is not the whole truth; we need to look at other parameters. AHI may not be the correct metric to look at in patients with various cardiovascular diseases.”
Her analysis also showed that patients with at least 10 minutes of sleep time with an oxygen saturation rate of 90% or less had a 64% increased rate of later atrial fibrillation hospitalizations, compared with those with fewer than 10 minutes spent in this state. Nearly a quarter of the patients studied fell into this category.
“Nocturnal oxygen desaturation may be stronger than AHI for predicting atrial fibrillation development,” Dr. Kendzerska concluded. “The severity of OSA-related intermittent hypoxia may be more important than sleep fragmentation in the development of atrial fibrillation. These findings support a relationship between OSA, chronic nocturnal hypoxemia, and new onset atrial fibrillation.”
However, using oxygen desaturation instead of AHI to gauge the severity of OSA won’t solve all the challenges that sleep researchers currently face in trying to determine the efficacy of breathing interventions to prevent or treat cardiovascular disease. In the neutral SAVE trial, researchers used nocturnal oxygen saturation levels to select patients with clinically meaningful OSA.
Dr. Mehra and Dr. Kendzerska had no disclosures. Dr. Oldenburg has received consultant fees, honoraria, and/or research support from ResMed, Respicardia, and Weinmann.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
This article was updated on 7/10/17.
EXPERT ANALYSIS FROM ATS 2017
Outcomes/costs similar for minimally invasive vs. sternotomy-based mitral surgery
NEW YORK – Minimally invasive mitral valve surgery provides outcomes that match those of conventional sternotomy without increasing use of resources, and lower costs after surgery offset potentially higher operation costs, according to a single-center, propensity-matched analysis of almost 500 patients presented at the meeting sponsored by the American Association for Thoracic Surgery.
“Minimally invasive mitral surgery has excellent outcomes with fewer transfusions and less time ventilated in this representative cohort,” said Robert Hawkins, MD, of the University of Virginia, Charlottesville, in reporting the results.
“While operative times were longer, surgical costs remained statistically similar, and minimally invasive mitral surgery was associated with similar total costs in more complex mitral cases.”
Dr. Hawkins said this study included higher risk patients to attempt to overcome shortcomings of previously published reports that skewed toward lower-risk, highly selective mitral repairs for degenerative mitral disease. “They’re not really representative of the current state of minimally invasive mitral valve surgery as it currently stands in the higher risk patient population,” he said of previous studies.
Major outcomes were similar in both groups. “The mitral valve repair rate was about 81% for both groups, and the tricuspid valve repair rate was 8.8%,” Dr. Hawkins said. “About 35% had atrial fibrillation surgery, including both ablation and left atrial appendage ligation.”
Dr. Hawkins characterized outcomes in both surgical groups as “excellent,” and added, “The operative mortality rate was 1.3% and the major morbidity rate was 11% and not different between groups.”
Some key operative characteristics differed between the two groups. “As expected the cross clamp times and bypass times for the minimally invasive approaches were longer,” Dr. Hawkins said. Also, those who had minimally invasive mitral surgery had a “dramatic decrease” in transfusion rates.
With regard to resource utilization, minimally invasive surgery had longer operative times – an average of 291 minutes vs. 222 minutes (P less than .0001) – but similar or improved use of postoperative resources. “We see that the minimally invasive approach leads to decreased treatment and ancillary costs without a statistically significant difference in surgical costs despite the longer operative times,” Dr. Hawkins said.
However, he noted the high variability of total hospital costs in higher-risk populations complicate any head-to-head comparisons of resource utilization between the conventional and minimally invasive approaches, so the researchers attempted to drill down to identify predictors of resource use. Using a regression model, they found that minimally invasive approach may actually save money, although this finding was not statistically significant (–$1,524; P = 0.83).
“We see that the major drivers of costs are complications,” Dr. Hawkins said. “Morbidity and mortality led to a $54,000 cost increase, and the addition of tricuspid repair also led to about $60,000 higher costs, which is more likely related to higher risk and thus complications. The costs of higher-acuity cases are driven by the complications and not the approach.”
Dr. Hawkins reported no financial relationships. Dr. Ailawadi disclosed consulting agreements with Edwards Lifesciences, Abbott, Medtronic, and AtriCure.
NEW YORK – Minimally invasive mitral valve surgery provides outcomes that match those of conventional sternotomy without increasing use of resources, and lower costs after surgery offset potentially higher operation costs, according to a single-center, propensity-matched analysis of almost 500 patients presented at the meeting sponsored by the American Association for Thoracic Surgery.
“Minimally invasive mitral surgery has excellent outcomes with fewer transfusions and less time ventilated in this representative cohort,” said Robert Hawkins, MD, of the University of Virginia, Charlottesville, in reporting the results.
“While operative times were longer, surgical costs remained statistically similar, and minimally invasive mitral surgery was associated with similar total costs in more complex mitral cases.”
Dr. Hawkins said this study included higher risk patients to attempt to overcome shortcomings of previously published reports that skewed toward lower-risk, highly selective mitral repairs for degenerative mitral disease. “They’re not really representative of the current state of minimally invasive mitral valve surgery as it currently stands in the higher risk patient population,” he said of previous studies.
Major outcomes were similar in both groups. “The mitral valve repair rate was about 81% for both groups, and the tricuspid valve repair rate was 8.8%,” Dr. Hawkins said. “About 35% had atrial fibrillation surgery, including both ablation and left atrial appendage ligation.”
Dr. Hawkins characterized outcomes in both surgical groups as “excellent,” and added, “The operative mortality rate was 1.3% and the major morbidity rate was 11% and not different between groups.”
Some key operative characteristics differed between the two groups. “As expected the cross clamp times and bypass times for the minimally invasive approaches were longer,” Dr. Hawkins said. Also, those who had minimally invasive mitral surgery had a “dramatic decrease” in transfusion rates.
With regard to resource utilization, minimally invasive surgery had longer operative times – an average of 291 minutes vs. 222 minutes (P less than .0001) – but similar or improved use of postoperative resources. “We see that the minimally invasive approach leads to decreased treatment and ancillary costs without a statistically significant difference in surgical costs despite the longer operative times,” Dr. Hawkins said.
However, he noted the high variability of total hospital costs in higher-risk populations complicate any head-to-head comparisons of resource utilization between the conventional and minimally invasive approaches, so the researchers attempted to drill down to identify predictors of resource use. Using a regression model, they found that minimally invasive approach may actually save money, although this finding was not statistically significant (–$1,524; P = 0.83).
“We see that the major drivers of costs are complications,” Dr. Hawkins said. “Morbidity and mortality led to a $54,000 cost increase, and the addition of tricuspid repair also led to about $60,000 higher costs, which is more likely related to higher risk and thus complications. The costs of higher-acuity cases are driven by the complications and not the approach.”
Dr. Hawkins reported no financial relationships. Dr. Ailawadi disclosed consulting agreements with Edwards Lifesciences, Abbott, Medtronic, and AtriCure.
NEW YORK – Minimally invasive mitral valve surgery provides outcomes that match those of conventional sternotomy without increasing use of resources, and lower costs after surgery offset potentially higher operation costs, according to a single-center, propensity-matched analysis of almost 500 patients presented at the meeting sponsored by the American Association for Thoracic Surgery.
“Minimally invasive mitral surgery has excellent outcomes with fewer transfusions and less time ventilated in this representative cohort,” said Robert Hawkins, MD, of the University of Virginia, Charlottesville, in reporting the results.
“While operative times were longer, surgical costs remained statistically similar, and minimally invasive mitral surgery was associated with similar total costs in more complex mitral cases.”
Dr. Hawkins said this study included higher risk patients to attempt to overcome shortcomings of previously published reports that skewed toward lower-risk, highly selective mitral repairs for degenerative mitral disease. “They’re not really representative of the current state of minimally invasive mitral valve surgery as it currently stands in the higher risk patient population,” he said of previous studies.
Major outcomes were similar in both groups. “The mitral valve repair rate was about 81% for both groups, and the tricuspid valve repair rate was 8.8%,” Dr. Hawkins said. “About 35% had atrial fibrillation surgery, including both ablation and left atrial appendage ligation.”
Dr. Hawkins characterized outcomes in both surgical groups as “excellent,” and added, “The operative mortality rate was 1.3% and the major morbidity rate was 11% and not different between groups.”
Some key operative characteristics differed between the two groups. “As expected the cross clamp times and bypass times for the minimally invasive approaches were longer,” Dr. Hawkins said. Also, those who had minimally invasive mitral surgery had a “dramatic decrease” in transfusion rates.
With regard to resource utilization, minimally invasive surgery had longer operative times – an average of 291 minutes vs. 222 minutes (P less than .0001) – but similar or improved use of postoperative resources. “We see that the minimally invasive approach leads to decreased treatment and ancillary costs without a statistically significant difference in surgical costs despite the longer operative times,” Dr. Hawkins said.
However, he noted the high variability of total hospital costs in higher-risk populations complicate any head-to-head comparisons of resource utilization between the conventional and minimally invasive approaches, so the researchers attempted to drill down to identify predictors of resource use. Using a regression model, they found that minimally invasive approach may actually save money, although this finding was not statistically significant (–$1,524; P = 0.83).
“We see that the major drivers of costs are complications,” Dr. Hawkins said. “Morbidity and mortality led to a $54,000 cost increase, and the addition of tricuspid repair also led to about $60,000 higher costs, which is more likely related to higher risk and thus complications. The costs of higher-acuity cases are driven by the complications and not the approach.”
Dr. Hawkins reported no financial relationships. Dr. Ailawadi disclosed consulting agreements with Edwards Lifesciences, Abbott, Medtronic, and AtriCure.
AT THE 2017 MITRAL VALVE CONCLAVE
Key clinical point: Outcomes and costs of minimally invasive mitral surgery are similar to that of conventional sternotomy for mitral valve surgery.
Major finding: Mortality rates of 1.3% and major morbidity rates of 11% were similar in both groups.
Data source: Propensity-matched analysis of 479 patients who had a primary mitral valve operation from January 2010 to June 2016 at the University of Virginia.
Disclosures: Dr. Hawkins reported no financial disclosures. Coauthor Dr. Gorav Ailawadi disclosed consulting agreements with Edwards Lifesciences, Abbott, Medtronic, and AtriCure.
Concomitant MIMV-TVS no worse than MIMV alone
NEW YORK – Concurrent mitral-tricuspid valve surgery has similar outcomes to isolated minimally invasive mitral valve surgery, according to results of a 12-year review reported at the 2017 Mitral Valve Conclave, sponsored by the American Association for Thoracic Surgery.
Indications for minimally invasive tricuspid valve surgery done at the same time of mitral valve surgery have not been well established, in part because the outcomes of such combined procedures have been underreported.
Dr. Kilic noted that patients who had concomitant TVS were typically higher risk at baseline. “The concomitant group was older, had a higher percentage of female patients, and higher rates of chronic lung disease and cerebrovascular disease as well,” Dr. Kilic said. In comparing the isolated MIMV surgery and MIMV-TVS groups in the unmatched analysis, 9% vs. 14% had chronic lung disease (P = .05), 12% vs. 16% had coronary artery disease (P = .15), 7% vs. 12% had cerebrovascular disease (P = .04), and 93% vs. 90% had elective surgery (P = .18). The majority of tricuspid repairs were for severe tricuspid regurgitation (TR) or moderate TR with a dilated annulus of 40 mm or greater.
The operative characteristics differed significantly between the two groups. “As one might expect, the cardiopulmonary bypass time and aortic occlusion times were longer in the concomitant group; and balloon aortic occlusion was used in more than 70% in each cohort,” Dr. Kilic said. Those differences were similar in the propensity-matched cohort: bypass times were 147.5 minutes for isolated MIMV surgery and 174.6 minutes for MIMV-TVS (P less than .001); and aortic occlusion time 104.8 vs. 128 minutes (P less than .001), respectively.
Operative mortality was 3% for isolated MIMV surgery and 4% for concurrent MIMV-TVS (P = .73), but the isolated MIMV surgery group required fewer permanent pacemakers, 1% vs. 6% (P = .03).
“Aside from permanent pacemaker implantation, the rates of every other complication were similar, including stoke, limb ischemia, atrial fibrillation, gastrointestinal complications, respiratory complications, blood product transfusions as well as discharge to home rates,” Dr. Kilic said. Median hospital length of stays were also similar: 7 days for isolated MIMV surgery vs. 8 days for MIMV-TVS (P = .13).
One limitation of the study Dr. Kilic pointed out was that the decision to perform concomitant MIMV-TVS was surgeon dependent.
Dr. Kilic reported having no financial disclosures.
NEW YORK – Concurrent mitral-tricuspid valve surgery has similar outcomes to isolated minimally invasive mitral valve surgery, according to results of a 12-year review reported at the 2017 Mitral Valve Conclave, sponsored by the American Association for Thoracic Surgery.
Indications for minimally invasive tricuspid valve surgery done at the same time of mitral valve surgery have not been well established, in part because the outcomes of such combined procedures have been underreported.
Dr. Kilic noted that patients who had concomitant TVS were typically higher risk at baseline. “The concomitant group was older, had a higher percentage of female patients, and higher rates of chronic lung disease and cerebrovascular disease as well,” Dr. Kilic said. In comparing the isolated MIMV surgery and MIMV-TVS groups in the unmatched analysis, 9% vs. 14% had chronic lung disease (P = .05), 12% vs. 16% had coronary artery disease (P = .15), 7% vs. 12% had cerebrovascular disease (P = .04), and 93% vs. 90% had elective surgery (P = .18). The majority of tricuspid repairs were for severe tricuspid regurgitation (TR) or moderate TR with a dilated annulus of 40 mm or greater.
The operative characteristics differed significantly between the two groups. “As one might expect, the cardiopulmonary bypass time and aortic occlusion times were longer in the concomitant group; and balloon aortic occlusion was used in more than 70% in each cohort,” Dr. Kilic said. Those differences were similar in the propensity-matched cohort: bypass times were 147.5 minutes for isolated MIMV surgery and 174.6 minutes for MIMV-TVS (P less than .001); and aortic occlusion time 104.8 vs. 128 minutes (P less than .001), respectively.
Operative mortality was 3% for isolated MIMV surgery and 4% for concurrent MIMV-TVS (P = .73), but the isolated MIMV surgery group required fewer permanent pacemakers, 1% vs. 6% (P = .03).
“Aside from permanent pacemaker implantation, the rates of every other complication were similar, including stoke, limb ischemia, atrial fibrillation, gastrointestinal complications, respiratory complications, blood product transfusions as well as discharge to home rates,” Dr. Kilic said. Median hospital length of stays were also similar: 7 days for isolated MIMV surgery vs. 8 days for MIMV-TVS (P = .13).
One limitation of the study Dr. Kilic pointed out was that the decision to perform concomitant MIMV-TVS was surgeon dependent.
Dr. Kilic reported having no financial disclosures.
NEW YORK – Concurrent mitral-tricuspid valve surgery has similar outcomes to isolated minimally invasive mitral valve surgery, according to results of a 12-year review reported at the 2017 Mitral Valve Conclave, sponsored by the American Association for Thoracic Surgery.
Indications for minimally invasive tricuspid valve surgery done at the same time of mitral valve surgery have not been well established, in part because the outcomes of such combined procedures have been underreported.
Dr. Kilic noted that patients who had concomitant TVS were typically higher risk at baseline. “The concomitant group was older, had a higher percentage of female patients, and higher rates of chronic lung disease and cerebrovascular disease as well,” Dr. Kilic said. In comparing the isolated MIMV surgery and MIMV-TVS groups in the unmatched analysis, 9% vs. 14% had chronic lung disease (P = .05), 12% vs. 16% had coronary artery disease (P = .15), 7% vs. 12% had cerebrovascular disease (P = .04), and 93% vs. 90% had elective surgery (P = .18). The majority of tricuspid repairs were for severe tricuspid regurgitation (TR) or moderate TR with a dilated annulus of 40 mm or greater.
The operative characteristics differed significantly between the two groups. “As one might expect, the cardiopulmonary bypass time and aortic occlusion times were longer in the concomitant group; and balloon aortic occlusion was used in more than 70% in each cohort,” Dr. Kilic said. Those differences were similar in the propensity-matched cohort: bypass times were 147.5 minutes for isolated MIMV surgery and 174.6 minutes for MIMV-TVS (P less than .001); and aortic occlusion time 104.8 vs. 128 minutes (P less than .001), respectively.
Operative mortality was 3% for isolated MIMV surgery and 4% for concurrent MIMV-TVS (P = .73), but the isolated MIMV surgery group required fewer permanent pacemakers, 1% vs. 6% (P = .03).
“Aside from permanent pacemaker implantation, the rates of every other complication were similar, including stoke, limb ischemia, atrial fibrillation, gastrointestinal complications, respiratory complications, blood product transfusions as well as discharge to home rates,” Dr. Kilic said. Median hospital length of stays were also similar: 7 days for isolated MIMV surgery vs. 8 days for MIMV-TVS (P = .13).
One limitation of the study Dr. Kilic pointed out was that the decision to perform concomitant MIMV-TVS was surgeon dependent.
Dr. Kilic reported having no financial disclosures.
AT THE 2017 MITRAL VALVE CONCLAVE
Key clinical point: Outcomes of isolated minimally invasive mitral valve surgery (MIMV) and MIMV with concomitant tricuspid valve surgery (TVS) are similar.
Major finding: Operative mortality was 3% for isolated MIMV and 4% for concurrent MIMV-TVS.
Data source: Single-center review of 1,158 patients who underwent either isolated MIMV or MIMV-TVS from 2002 to 2014, including a propensity-matched cohort.
Disclosures: Dr. Kilic reported having no financial disclosures.
High TAVR rates linked to fewer readmissions
WASHINGTON – Hospitals with a higher volume of transcatheter aortic valve replacements (TAVRs) have significantly lower 30-day readmission rates, according to an observational study.
In a study of 129 hospitals, those that performed more than 100 TAVR procedures had a 24% and 25% lower readmission rate compared with hospitals that performed 50 to100 TAVRs (P less than .001) and hospitals that performed fewer that 50 TAVRs (P = .007) respectively (JAMA Cardiol. 2017 May 11. doi: 10.1001/jamacardio.2017.1630).
This finding could have serious financial and medical implications for hospitals that are deciding whether or not to focus on this minimally invasive procedure, according to Sahil Khera, MD, MPH, chief resident and cardiology fellow at New York Medical College, Valhalla, and his colleagues.
“Lower readmission rates at high-volume hospitals substantially reduce health care expenditure,” said Dr. Khera and colleagues. “As new TAVR programs open across the country, these data will guide policymakers to identify targets for optimizing and standardizing TAVR outcomes across hospitals.”
To study the correlation between TAVR procedures and readmission rates, the investigators gathered records on hospitals that performed at least five TAVRs in 2014, which were then categorized into high-, medium-, or low-volume categories, and cross-referenced with the 2014 Nationwide Readmissions Database.
Of the 16,252 TAVR procedures conducted in 2014, 663 (4%), 3,067 (19%), and 12,522 (77%) were performed at low-, medium-, and high-volume hospitals, respectively, according to the investigators.
Patients undergoing these procedures were on average 81 years of age, with an average of four Elixhauser comorbidities, most commonly dyslipidemia (64%), hypertension (80%), heart failure (75%), and known coronary artery disease (69%), with a majority having undergone an endovascular procedure (83%).
However, the researchers found the population of TAVR patients of high volume hospitals were slightly younger, had fewer women, were more likely to be in a higher income household, and were less likely to undergo a transapical procedure than in low volume hospitals, which Dr. Khera and fellow researchers believe may have some impact on their findings.
“Low-volume hospitals were more likely to operate on patients with a higher number of comorbidities compared with high-volume hospitals and were more likely to use the TA approach,” according to investigators, “Transapical TAVR is associated with poorer short- and intermediate-term mortality, increased use of skilled nursing care facilities, longer hospital stays, and readmissions when compared with transfemoral TAVR.”
Overall, there were 2,667 readmissions reported, among which high volume hospitals reported a 30-day readmission rate of 15.6%, while low- and medium-volume hospitals reported similarly higher rates of 19.5% and 19%.
When looking into the causes for these readmissions, the investigators found that 1,619 (61%) were due to noncardiac causes, which appeared in all three hospitals, despite a larger proportion present in low-volume hospitals as opposed to medium and high-volume hospitals (65.6% vs. 60.1% and 60.6%, respectively).
“Infection, respiratory, endocrine/metabolic, renal, and trauma problems were more common in low-volume hospitals,” according to the researchers. “Whereas gastrointestinal and TIA/stroke issues were more common in medium and high volume hospitals.”
While price and length of stay did not differ among the volume categories, the investigators estimate the lower rate of readmissions saved high-volume hospitals approximately $6.5 million.
They found that while the difference of readmissions between hospital classifications narrowed when controlling for experience, the margin was still significant. They admitted, however, that the possibility of greater access to more technologically advanced TAVR in high-volume hospitals may affect the findings.
This study was limited by administrative nature of the database used, which does not make available information such as valve type, patient risk scores, or medications.
One investigator has received personal fees from Edwards Lifesciences and Medtronic; another has received grants and personal fees from various pharmaceutical companies, educational institutions, and publications; and a third has consulted for Medtronic.
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
Considering the idea of using readmissions in comparison to rate of TAVR procedures is interesting, the number of confounds are too great to give any kind of accurate representation of medical practice. While the authors of this study do address its limitations, including a learning curve as it relates to the risk of inpatient mortality, the number of adjustments that must be made to account for the additional confounding factors are simply too insurmountable to give an accurate estimate of statistical and clinical importance.
For example, researchers found TAVR readmissions were associated with certain baseline comorbidities, access sites, and complications. However, association does not mean causation and so the categorization of cardiac-related vs. noncardiac-related readmissions must be approached with some caution.
If one were to try to use readmission rates after TAVR to argue for reimbursement of the procedure, one would need to determine a well established, validated reimbursement rate for TAVR readmissions, which has not been done.
Also, the advancing nature of this procedure, combined with a constant focus from hospitals to reduce readmission rates means any baseline for readmissions used would most likely be out of date.
It would be unlikely for investigators to factor in the cause of reduced readmission rates, which could be a factor of increased technology, more experienced physicians, lower-risk patients, or any combination thereof.
Holding TAVR sites accountable for quality of care is of course important, but using readmission rates to determine something like funding is not appropriate when the measurement being used is so complex.
Perhaps a better approach would be to widen access for low volume hospitals to resources that would improve the TAVR processes and encourage using financial incentives.
Evaluations by physical therapists or a similar procedure should be put into place before discharge to assess a patient’s risk of readmission.
Overall, this is a multifaceted issue that would be better helped by promoting TAVR best practices and encouraging hospitals to compare themselves against each other to reduce unnecessary readmissions.
John D. Carroll, MD, is professor of medicine and director of the Cardiac and Vascular Center at the University of Colorado, Denver. He made his remarks in an editorial in JAMA Cardiology ( doi: 10.1001/jamacardio.2017.1650 ).
Considering the idea of using readmissions in comparison to rate of TAVR procedures is interesting, the number of confounds are too great to give any kind of accurate representation of medical practice. While the authors of this study do address its limitations, including a learning curve as it relates to the risk of inpatient mortality, the number of adjustments that must be made to account for the additional confounding factors are simply too insurmountable to give an accurate estimate of statistical and clinical importance.
For example, researchers found TAVR readmissions were associated with certain baseline comorbidities, access sites, and complications. However, association does not mean causation and so the categorization of cardiac-related vs. noncardiac-related readmissions must be approached with some caution.
If one were to try to use readmission rates after TAVR to argue for reimbursement of the procedure, one would need to determine a well established, validated reimbursement rate for TAVR readmissions, which has not been done.
Also, the advancing nature of this procedure, combined with a constant focus from hospitals to reduce readmission rates means any baseline for readmissions used would most likely be out of date.
It would be unlikely for investigators to factor in the cause of reduced readmission rates, which could be a factor of increased technology, more experienced physicians, lower-risk patients, or any combination thereof.
Holding TAVR sites accountable for quality of care is of course important, but using readmission rates to determine something like funding is not appropriate when the measurement being used is so complex.
Perhaps a better approach would be to widen access for low volume hospitals to resources that would improve the TAVR processes and encourage using financial incentives.
Evaluations by physical therapists or a similar procedure should be put into place before discharge to assess a patient’s risk of readmission.
Overall, this is a multifaceted issue that would be better helped by promoting TAVR best practices and encouraging hospitals to compare themselves against each other to reduce unnecessary readmissions.
John D. Carroll, MD, is professor of medicine and director of the Cardiac and Vascular Center at the University of Colorado, Denver. He made his remarks in an editorial in JAMA Cardiology ( doi: 10.1001/jamacardio.2017.1650 ).
Considering the idea of using readmissions in comparison to rate of TAVR procedures is interesting, the number of confounds are too great to give any kind of accurate representation of medical practice. While the authors of this study do address its limitations, including a learning curve as it relates to the risk of inpatient mortality, the number of adjustments that must be made to account for the additional confounding factors are simply too insurmountable to give an accurate estimate of statistical and clinical importance.
For example, researchers found TAVR readmissions were associated with certain baseline comorbidities, access sites, and complications. However, association does not mean causation and so the categorization of cardiac-related vs. noncardiac-related readmissions must be approached with some caution.
If one were to try to use readmission rates after TAVR to argue for reimbursement of the procedure, one would need to determine a well established, validated reimbursement rate for TAVR readmissions, which has not been done.
Also, the advancing nature of this procedure, combined with a constant focus from hospitals to reduce readmission rates means any baseline for readmissions used would most likely be out of date.
It would be unlikely for investigators to factor in the cause of reduced readmission rates, which could be a factor of increased technology, more experienced physicians, lower-risk patients, or any combination thereof.
Holding TAVR sites accountable for quality of care is of course important, but using readmission rates to determine something like funding is not appropriate when the measurement being used is so complex.
Perhaps a better approach would be to widen access for low volume hospitals to resources that would improve the TAVR processes and encourage using financial incentives.
Evaluations by physical therapists or a similar procedure should be put into place before discharge to assess a patient’s risk of readmission.
Overall, this is a multifaceted issue that would be better helped by promoting TAVR best practices and encouraging hospitals to compare themselves against each other to reduce unnecessary readmissions.
John D. Carroll, MD, is professor of medicine and director of the Cardiac and Vascular Center at the University of Colorado, Denver. He made his remarks in an editorial in JAMA Cardiology ( doi: 10.1001/jamacardio.2017.1650 ).
WASHINGTON – Hospitals with a higher volume of transcatheter aortic valve replacements (TAVRs) have significantly lower 30-day readmission rates, according to an observational study.
In a study of 129 hospitals, those that performed more than 100 TAVR procedures had a 24% and 25% lower readmission rate compared with hospitals that performed 50 to100 TAVRs (P less than .001) and hospitals that performed fewer that 50 TAVRs (P = .007) respectively (JAMA Cardiol. 2017 May 11. doi: 10.1001/jamacardio.2017.1630).
This finding could have serious financial and medical implications for hospitals that are deciding whether or not to focus on this minimally invasive procedure, according to Sahil Khera, MD, MPH, chief resident and cardiology fellow at New York Medical College, Valhalla, and his colleagues.
“Lower readmission rates at high-volume hospitals substantially reduce health care expenditure,” said Dr. Khera and colleagues. “As new TAVR programs open across the country, these data will guide policymakers to identify targets for optimizing and standardizing TAVR outcomes across hospitals.”
To study the correlation between TAVR procedures and readmission rates, the investigators gathered records on hospitals that performed at least five TAVRs in 2014, which were then categorized into high-, medium-, or low-volume categories, and cross-referenced with the 2014 Nationwide Readmissions Database.
Of the 16,252 TAVR procedures conducted in 2014, 663 (4%), 3,067 (19%), and 12,522 (77%) were performed at low-, medium-, and high-volume hospitals, respectively, according to the investigators.
Patients undergoing these procedures were on average 81 years of age, with an average of four Elixhauser comorbidities, most commonly dyslipidemia (64%), hypertension (80%), heart failure (75%), and known coronary artery disease (69%), with a majority having undergone an endovascular procedure (83%).
However, the researchers found the population of TAVR patients of high volume hospitals were slightly younger, had fewer women, were more likely to be in a higher income household, and were less likely to undergo a transapical procedure than in low volume hospitals, which Dr. Khera and fellow researchers believe may have some impact on their findings.
“Low-volume hospitals were more likely to operate on patients with a higher number of comorbidities compared with high-volume hospitals and were more likely to use the TA approach,” according to investigators, “Transapical TAVR is associated with poorer short- and intermediate-term mortality, increased use of skilled nursing care facilities, longer hospital stays, and readmissions when compared with transfemoral TAVR.”
Overall, there were 2,667 readmissions reported, among which high volume hospitals reported a 30-day readmission rate of 15.6%, while low- and medium-volume hospitals reported similarly higher rates of 19.5% and 19%.
When looking into the causes for these readmissions, the investigators found that 1,619 (61%) were due to noncardiac causes, which appeared in all three hospitals, despite a larger proportion present in low-volume hospitals as opposed to medium and high-volume hospitals (65.6% vs. 60.1% and 60.6%, respectively).
“Infection, respiratory, endocrine/metabolic, renal, and trauma problems were more common in low-volume hospitals,” according to the researchers. “Whereas gastrointestinal and TIA/stroke issues were more common in medium and high volume hospitals.”
While price and length of stay did not differ among the volume categories, the investigators estimate the lower rate of readmissions saved high-volume hospitals approximately $6.5 million.
They found that while the difference of readmissions between hospital classifications narrowed when controlling for experience, the margin was still significant. They admitted, however, that the possibility of greater access to more technologically advanced TAVR in high-volume hospitals may affect the findings.
This study was limited by administrative nature of the database used, which does not make available information such as valve type, patient risk scores, or medications.
One investigator has received personal fees from Edwards Lifesciences and Medtronic; another has received grants and personal fees from various pharmaceutical companies, educational institutions, and publications; and a third has consulted for Medtronic.
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
WASHINGTON – Hospitals with a higher volume of transcatheter aortic valve replacements (TAVRs) have significantly lower 30-day readmission rates, according to an observational study.
In a study of 129 hospitals, those that performed more than 100 TAVR procedures had a 24% and 25% lower readmission rate compared with hospitals that performed 50 to100 TAVRs (P less than .001) and hospitals that performed fewer that 50 TAVRs (P = .007) respectively (JAMA Cardiol. 2017 May 11. doi: 10.1001/jamacardio.2017.1630).
This finding could have serious financial and medical implications for hospitals that are deciding whether or not to focus on this minimally invasive procedure, according to Sahil Khera, MD, MPH, chief resident and cardiology fellow at New York Medical College, Valhalla, and his colleagues.
“Lower readmission rates at high-volume hospitals substantially reduce health care expenditure,” said Dr. Khera and colleagues. “As new TAVR programs open across the country, these data will guide policymakers to identify targets for optimizing and standardizing TAVR outcomes across hospitals.”
To study the correlation between TAVR procedures and readmission rates, the investigators gathered records on hospitals that performed at least five TAVRs in 2014, which were then categorized into high-, medium-, or low-volume categories, and cross-referenced with the 2014 Nationwide Readmissions Database.
Of the 16,252 TAVR procedures conducted in 2014, 663 (4%), 3,067 (19%), and 12,522 (77%) were performed at low-, medium-, and high-volume hospitals, respectively, according to the investigators.
Patients undergoing these procedures were on average 81 years of age, with an average of four Elixhauser comorbidities, most commonly dyslipidemia (64%), hypertension (80%), heart failure (75%), and known coronary artery disease (69%), with a majority having undergone an endovascular procedure (83%).
However, the researchers found the population of TAVR patients of high volume hospitals were slightly younger, had fewer women, were more likely to be in a higher income household, and were less likely to undergo a transapical procedure than in low volume hospitals, which Dr. Khera and fellow researchers believe may have some impact on their findings.
“Low-volume hospitals were more likely to operate on patients with a higher number of comorbidities compared with high-volume hospitals and were more likely to use the TA approach,” according to investigators, “Transapical TAVR is associated with poorer short- and intermediate-term mortality, increased use of skilled nursing care facilities, longer hospital stays, and readmissions when compared with transfemoral TAVR.”
Overall, there were 2,667 readmissions reported, among which high volume hospitals reported a 30-day readmission rate of 15.6%, while low- and medium-volume hospitals reported similarly higher rates of 19.5% and 19%.
When looking into the causes for these readmissions, the investigators found that 1,619 (61%) were due to noncardiac causes, which appeared in all three hospitals, despite a larger proportion present in low-volume hospitals as opposed to medium and high-volume hospitals (65.6% vs. 60.1% and 60.6%, respectively).
“Infection, respiratory, endocrine/metabolic, renal, and trauma problems were more common in low-volume hospitals,” according to the researchers. “Whereas gastrointestinal and TIA/stroke issues were more common in medium and high volume hospitals.”
While price and length of stay did not differ among the volume categories, the investigators estimate the lower rate of readmissions saved high-volume hospitals approximately $6.5 million.
They found that while the difference of readmissions between hospital classifications narrowed when controlling for experience, the margin was still significant. They admitted, however, that the possibility of greater access to more technologically advanced TAVR in high-volume hospitals may affect the findings.
This study was limited by administrative nature of the database used, which does not make available information such as valve type, patient risk scores, or medications.
One investigator has received personal fees from Edwards Lifesciences and Medtronic; another has received grants and personal fees from various pharmaceutical companies, educational institutions, and publications; and a third has consulted for Medtronic.
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
FROM JAMA CARDIOLOGY
Key clinical point:
Major finding: Hospitals that performed more than 100 TAVR procedures reported significantly lower 30-day readmission rates, compared with those that performed 50-100 procedures and hospitals that performed less than 50.
Data source: Observational study of 129 hospitals that performed at least five TAVRs in 2015, and documents gathered from the 2014 Nationwide Readmissions Database.
Disclosures: One investigator has received personal fees from Edwards Lifesciences and Medtronic; another has received grants and personal fees from various pharmaceutical companies, educational institutions, and publications; and a third has consulted for Medtronic.
Surgeon volume tied to mitral valve surgery outcomes
CHICAGO – A total annual surgeon volume of fewer than 25 operations was associated with increased 1-year mortality and reoperation rates, according to a study presented at the 2017 American Association for Thoracic Surgery Centennial.
Improvements in repair rates, survival, and freedom from reoperation increased with increasing surgeon case volumes, Joanna Chikwe, MD, and her colleagues at the Icahn School of Medicine at Mount Sinai, New York, stated.
The researchers compared repair rates, long-term survival, and risk of postrepair reoperation in patients with degenerative disease according to total annual surgeon volume, which was defined as any mitral valve operation for any cause during the study period. The study was simultaneously published in the Journal of the American College of Cardiology (2017 May 16;69[19]:2397-406).
Mitral valve repair is the preferred treatment, compared with valve replacement, for the treatment of severe mitral valve regurgitation in patients who have degenerative valve disease with mitral valve prolapse, and both U.S. and European guidelines strongly recommend valve repair whenever possible, according to Dr. Chikwe and her colleagues.
But, “mitral valve replacement unfortunately remains relatively common in patients with degenerative valve disease,” they stated.
A total of 313 surgeons from 41 institutions met the study eligibility criteria, according to the researchers. They performed a median of 10 mitral valve operations per year (range, 1-230). The median annual institutional mitral valve volume was 59 mitral valve operations, ranging from a minimum of 6 to a maximum of 310 operations. Repair rates for primary mitral valve operations for any cause at all 41 institutions varied from 15% to 83%, and repair rates for degenerative mitral valve operations varied from 25% to 100%.
In the study cohort, surgeons with a total annual volume of less than 25 operations carried out 25% of procedures.
After multivariable adjustment, total annual surgeon volume was independently associated with the probability of mitral valve repair. The chance of repair increased significantly by 13% for every 10-case increment in total annual surgeon volume (P less than .001).
In addition, compared with patients operated on by surgeons with a total annual surgeon volume of 10 or fewer operations, patients operated on by surgeons with a total annual surgeon volume of greater than 50 operations were more than three times as likely to undergo mitral valve repair rather than replacement.
A total annual surgeon volume of less than 25 operations was associated with lower mitral valve repair rates and with increased 1-year mortality and mitral valve reoperation rates. Improvements in repair rates, survival, and freedom from reoperation increased with increasing surgeon case volumes.
After 1 year of repair or replacement, the actuarial survival of patients with degenerative mitral valve disease who were operated on by surgeons performing greater than 50 operations per year was 97.8%, compared with 94.1% for patients operated on by surgeons performing less than or equal to 10 operations a year.
Compared with replacement, mitral repair was significantly associated with better survival, but total annual surgeon volume still remained a significant independent predictor (P less than .001). In addition, for those patients who underwent mitral valve repair, total annual surgeon volume was a significant independent predictor of late death.
The results are important, the investigators noted, given that the median number of mitral valve operations performed annually by individual surgeons in the United States was five, according to an analysis of the Society of Thoracic Surgeons database – and that, in New York state, most surgeons actually performed less than one mitral operation per month.
There were significant differences seen in the patient characteristics across surgeons’ case volume groups. The prevalence of congestive heart failure was significantly higher in patients operated on by surgeons with lower volumes, and the proportion of patients undergoing urgent surgery was also significantly higher for lower-volume surgeons.
“This leads to a double jeopardy, where sicker patients are adversely affected by the lower repair rates and poorer outcomes seen with lower-volume surgeons, and it underscores the need to refer the highest-risk patients to high-volume surgeons,” said Dr. Chickwe and her colleagues.
However, “even among high-volume surgeons, there was an observed variability of degenerative disease repair rates, ranging from 19% to nearly 100%,” they added. “This finding reflects that surgeon volume is not the only factor for better outcomes, and it emphasizes the need for more transparency of surgeon-related factors and outcomes of degenerative mitral valve surgery for patients and referring cardiologists.
“Considering that there was an incremental improvement in survival and probability of repair with increasing volume over 25 operations, one could make the argument that a minimum volume target of 50, or even more, operations would be optimal,” the researchers noted. “Developing more very high-volume surgeons experienced in mitral valve repair would likely be particularly beneficial for patients with complex but repairable mitral valve disease, and for asymptomatic patients whose repair feasibility would optimally approach 100%.”
Dr. David Adams is the national coprincipal investigator of the Core Valve United States Pivotal Trial, supported by Medtronic. Dr. Chikwe received speaker honoraria from Edwards Lifesciences. The other coauthors had no disclosures to report.
CHICAGO – A total annual surgeon volume of fewer than 25 operations was associated with increased 1-year mortality and reoperation rates, according to a study presented at the 2017 American Association for Thoracic Surgery Centennial.
Improvements in repair rates, survival, and freedom from reoperation increased with increasing surgeon case volumes, Joanna Chikwe, MD, and her colleagues at the Icahn School of Medicine at Mount Sinai, New York, stated.
The researchers compared repair rates, long-term survival, and risk of postrepair reoperation in patients with degenerative disease according to total annual surgeon volume, which was defined as any mitral valve operation for any cause during the study period. The study was simultaneously published in the Journal of the American College of Cardiology (2017 May 16;69[19]:2397-406).
Mitral valve repair is the preferred treatment, compared with valve replacement, for the treatment of severe mitral valve regurgitation in patients who have degenerative valve disease with mitral valve prolapse, and both U.S. and European guidelines strongly recommend valve repair whenever possible, according to Dr. Chikwe and her colleagues.
But, “mitral valve replacement unfortunately remains relatively common in patients with degenerative valve disease,” they stated.
A total of 313 surgeons from 41 institutions met the study eligibility criteria, according to the researchers. They performed a median of 10 mitral valve operations per year (range, 1-230). The median annual institutional mitral valve volume was 59 mitral valve operations, ranging from a minimum of 6 to a maximum of 310 operations. Repair rates for primary mitral valve operations for any cause at all 41 institutions varied from 15% to 83%, and repair rates for degenerative mitral valve operations varied from 25% to 100%.
In the study cohort, surgeons with a total annual volume of less than 25 operations carried out 25% of procedures.
After multivariable adjustment, total annual surgeon volume was independently associated with the probability of mitral valve repair. The chance of repair increased significantly by 13% for every 10-case increment in total annual surgeon volume (P less than .001).
In addition, compared with patients operated on by surgeons with a total annual surgeon volume of 10 or fewer operations, patients operated on by surgeons with a total annual surgeon volume of greater than 50 operations were more than three times as likely to undergo mitral valve repair rather than replacement.
A total annual surgeon volume of less than 25 operations was associated with lower mitral valve repair rates and with increased 1-year mortality and mitral valve reoperation rates. Improvements in repair rates, survival, and freedom from reoperation increased with increasing surgeon case volumes.
After 1 year of repair or replacement, the actuarial survival of patients with degenerative mitral valve disease who were operated on by surgeons performing greater than 50 operations per year was 97.8%, compared with 94.1% for patients operated on by surgeons performing less than or equal to 10 operations a year.
Compared with replacement, mitral repair was significantly associated with better survival, but total annual surgeon volume still remained a significant independent predictor (P less than .001). In addition, for those patients who underwent mitral valve repair, total annual surgeon volume was a significant independent predictor of late death.
The results are important, the investigators noted, given that the median number of mitral valve operations performed annually by individual surgeons in the United States was five, according to an analysis of the Society of Thoracic Surgeons database – and that, in New York state, most surgeons actually performed less than one mitral operation per month.
There were significant differences seen in the patient characteristics across surgeons’ case volume groups. The prevalence of congestive heart failure was significantly higher in patients operated on by surgeons with lower volumes, and the proportion of patients undergoing urgent surgery was also significantly higher for lower-volume surgeons.
“This leads to a double jeopardy, where sicker patients are adversely affected by the lower repair rates and poorer outcomes seen with lower-volume surgeons, and it underscores the need to refer the highest-risk patients to high-volume surgeons,” said Dr. Chickwe and her colleagues.
However, “even among high-volume surgeons, there was an observed variability of degenerative disease repair rates, ranging from 19% to nearly 100%,” they added. “This finding reflects that surgeon volume is not the only factor for better outcomes, and it emphasizes the need for more transparency of surgeon-related factors and outcomes of degenerative mitral valve surgery for patients and referring cardiologists.
“Considering that there was an incremental improvement in survival and probability of repair with increasing volume over 25 operations, one could make the argument that a minimum volume target of 50, or even more, operations would be optimal,” the researchers noted. “Developing more very high-volume surgeons experienced in mitral valve repair would likely be particularly beneficial for patients with complex but repairable mitral valve disease, and for asymptomatic patients whose repair feasibility would optimally approach 100%.”
Dr. David Adams is the national coprincipal investigator of the Core Valve United States Pivotal Trial, supported by Medtronic. Dr. Chikwe received speaker honoraria from Edwards Lifesciences. The other coauthors had no disclosures to report.
CHICAGO – A total annual surgeon volume of fewer than 25 operations was associated with increased 1-year mortality and reoperation rates, according to a study presented at the 2017 American Association for Thoracic Surgery Centennial.
Improvements in repair rates, survival, and freedom from reoperation increased with increasing surgeon case volumes, Joanna Chikwe, MD, and her colleagues at the Icahn School of Medicine at Mount Sinai, New York, stated.
The researchers compared repair rates, long-term survival, and risk of postrepair reoperation in patients with degenerative disease according to total annual surgeon volume, which was defined as any mitral valve operation for any cause during the study period. The study was simultaneously published in the Journal of the American College of Cardiology (2017 May 16;69[19]:2397-406).
Mitral valve repair is the preferred treatment, compared with valve replacement, for the treatment of severe mitral valve regurgitation in patients who have degenerative valve disease with mitral valve prolapse, and both U.S. and European guidelines strongly recommend valve repair whenever possible, according to Dr. Chikwe and her colleagues.
But, “mitral valve replacement unfortunately remains relatively common in patients with degenerative valve disease,” they stated.
A total of 313 surgeons from 41 institutions met the study eligibility criteria, according to the researchers. They performed a median of 10 mitral valve operations per year (range, 1-230). The median annual institutional mitral valve volume was 59 mitral valve operations, ranging from a minimum of 6 to a maximum of 310 operations. Repair rates for primary mitral valve operations for any cause at all 41 institutions varied from 15% to 83%, and repair rates for degenerative mitral valve operations varied from 25% to 100%.
In the study cohort, surgeons with a total annual volume of less than 25 operations carried out 25% of procedures.
After multivariable adjustment, total annual surgeon volume was independently associated with the probability of mitral valve repair. The chance of repair increased significantly by 13% for every 10-case increment in total annual surgeon volume (P less than .001).
In addition, compared with patients operated on by surgeons with a total annual surgeon volume of 10 or fewer operations, patients operated on by surgeons with a total annual surgeon volume of greater than 50 operations were more than three times as likely to undergo mitral valve repair rather than replacement.
A total annual surgeon volume of less than 25 operations was associated with lower mitral valve repair rates and with increased 1-year mortality and mitral valve reoperation rates. Improvements in repair rates, survival, and freedom from reoperation increased with increasing surgeon case volumes.
After 1 year of repair or replacement, the actuarial survival of patients with degenerative mitral valve disease who were operated on by surgeons performing greater than 50 operations per year was 97.8%, compared with 94.1% for patients operated on by surgeons performing less than or equal to 10 operations a year.
Compared with replacement, mitral repair was significantly associated with better survival, but total annual surgeon volume still remained a significant independent predictor (P less than .001). In addition, for those patients who underwent mitral valve repair, total annual surgeon volume was a significant independent predictor of late death.
The results are important, the investigators noted, given that the median number of mitral valve operations performed annually by individual surgeons in the United States was five, according to an analysis of the Society of Thoracic Surgeons database – and that, in New York state, most surgeons actually performed less than one mitral operation per month.
There were significant differences seen in the patient characteristics across surgeons’ case volume groups. The prevalence of congestive heart failure was significantly higher in patients operated on by surgeons with lower volumes, and the proportion of patients undergoing urgent surgery was also significantly higher for lower-volume surgeons.
“This leads to a double jeopardy, where sicker patients are adversely affected by the lower repair rates and poorer outcomes seen with lower-volume surgeons, and it underscores the need to refer the highest-risk patients to high-volume surgeons,” said Dr. Chickwe and her colleagues.
However, “even among high-volume surgeons, there was an observed variability of degenerative disease repair rates, ranging from 19% to nearly 100%,” they added. “This finding reflects that surgeon volume is not the only factor for better outcomes, and it emphasizes the need for more transparency of surgeon-related factors and outcomes of degenerative mitral valve surgery for patients and referring cardiologists.
“Considering that there was an incremental improvement in survival and probability of repair with increasing volume over 25 operations, one could make the argument that a minimum volume target of 50, or even more, operations would be optimal,” the researchers noted. “Developing more very high-volume surgeons experienced in mitral valve repair would likely be particularly beneficial for patients with complex but repairable mitral valve disease, and for asymptomatic patients whose repair feasibility would optimally approach 100%.”
Dr. David Adams is the national coprincipal investigator of the Core Valve United States Pivotal Trial, supported by Medtronic. Dr. Chikwe received speaker honoraria from Edwards Lifesciences. The other coauthors had no disclosures to report.
FROM THE AATS ANNUAL MEETING AND THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Key clinical point:
Major finding: Mitral valve reoperation rates steadily decreased with increasing surgeon volume until 25 operations per year, coupled to an improved 1-year survival for every 10 additional operations more than that.
Data source: A mandatory New York state database containing 5,475 patients who underwent mitral valve repair between 2002 and 2013.
Disclosures: Dr. David Adams is the national coprincipal investigator of the Core Valve United States Pivotal Trial, supported by Medtronic. Dr. Joanna Chikwe received speaker honoraria from Edwards Lifesciences. The other coauthors had no disclosures to report.