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Tumor testing cost-effective for triage to germline testing in HGSOC patients
HONOLULU – Tumor testing for the triage of women with high-grade serous ovarian cancer to confirmatory genetic testing for BRCA mutations appears feasible, according to a cost-effectiveness analysis.
In fact, based on a Markov Monte Carlo simulation model developed to compare a tumor-testing approach with a universal germline testing approach, tumor testing yields an incremental cost-effectiveness ratio (ICER) of $127,000 per year of life gained, Janice S. Kwon, MD, reported at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.
“This is well in excess of [the $50,000 to $100,000 that] would be considered an acceptable threshold in the United States,” said Dr. Kwon of the University of British Columbia, Vancouver, Canada.
“We predict that tumor testing will be a cost-effective method of triage in women with high-grade serous ovarian cancer for confirmatory genetic testing to identify BRCA mutation carriers, assuming high sensitivity and acceptable cost of tumor testing,” she said.
In many areas around the world, germline testing is recommended for all women with high-grade serous ovarian cancer (HGSOC) because they have a 20% chance of carrying a BRCA 1 or 2 mutation.
“However, we all know that the referral rate for genetic testing is far from optimal, and furthermore, there are costs incurred to the healthcare system for resources utilized for genetic counseling and testing,” she said.
Tumor testing for triage is an alternative approach.
“If you consider 100 women with high-grade serous ovarian cancer and follow them through the conventional pathway in which all of them are referred for germline testing, you would expect to find 20 mutation carriers. If you take those same 100 women and apply tumor testing first, then 25 are expected to have a mutation in the tumor, Dr. Kwon said.
“If [all 25] are referred for germline testing, you would expect to find the same number of BRCA mutation carriers but with far less resource utilization.”
The remaining 75 are not expected to have a mutation in the tumor, and they may not need to be referred for confirmatory genetic testing unless there is a compelling family history or panel testing reveals a concerning mutation, she explained.
Since a randomized trial to compare these two strategies is not feasible, Dr. Kwon and her colleagues performed the current cost-effectiveness analysis.
The Markov simulation model was used to estimate the number of BRCA mutation carriers from index cases and their first degree relatives, and the number of cancer cases averted among first degree relatives, assuming they would undergo risk-reducing surgery.
“We conducted extensive sensitivity analyses to account for uncertainly around various parameters and we modeled a time horizon of 50 years,” Dr. Kwon noted. “We know that there are approximately 10,000 new [HGSOC] cases diagnosed in the United States every year, and we assumed that for every woman with [HGSOC], there was at least 1 female first-degree relative who would benefit from genetic testing.”
The model showed that applying tumor testing first would lead to a substantial reduction in the number of women undergoing germline mutation testing, but the number of BRCA mutation carriers identified would be comparable with the two strategies – assuming that the sensitivity of tumor testing is less than 100%, she said.
“As expected, the average lifetime costs associated with germline testing would be less than that for tumor testing, and even though you would expect that more first-degree relatives would be identified as BRCA mutation carriers after universal germline testing for index cases, the life expectancy gain for those first-degree relatives is averaged over the entire cohort at risk, and therefore the average incremental gain or benefit was actually quite small,” she said, noting that this yielded the ICER of $127,000 per year of life gained.
Based on this finding, tumor testing would be the preferred strategy, she added.
Sensitivity analysis around the sensitivity and specificity of tumor testing showed that tumor testing would be cost effective if its sensitivity is above 97%, and that tumor testing is cost-effective as long as it costs less than a third of the cost of germline testing – including genetic counseling.
Dr. Kwon has received research funding from AstraZeneca.
sworcester@mdedge.com
SOURCE: Kwon J et al., SGO 2019: Abstract 5.
HONOLULU – Tumor testing for the triage of women with high-grade serous ovarian cancer to confirmatory genetic testing for BRCA mutations appears feasible, according to a cost-effectiveness analysis.
In fact, based on a Markov Monte Carlo simulation model developed to compare a tumor-testing approach with a universal germline testing approach, tumor testing yields an incremental cost-effectiveness ratio (ICER) of $127,000 per year of life gained, Janice S. Kwon, MD, reported at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.
“This is well in excess of [the $50,000 to $100,000 that] would be considered an acceptable threshold in the United States,” said Dr. Kwon of the University of British Columbia, Vancouver, Canada.
“We predict that tumor testing will be a cost-effective method of triage in women with high-grade serous ovarian cancer for confirmatory genetic testing to identify BRCA mutation carriers, assuming high sensitivity and acceptable cost of tumor testing,” she said.
In many areas around the world, germline testing is recommended for all women with high-grade serous ovarian cancer (HGSOC) because they have a 20% chance of carrying a BRCA 1 or 2 mutation.
“However, we all know that the referral rate for genetic testing is far from optimal, and furthermore, there are costs incurred to the healthcare system for resources utilized for genetic counseling and testing,” she said.
Tumor testing for triage is an alternative approach.
“If you consider 100 women with high-grade serous ovarian cancer and follow them through the conventional pathway in which all of them are referred for germline testing, you would expect to find 20 mutation carriers. If you take those same 100 women and apply tumor testing first, then 25 are expected to have a mutation in the tumor, Dr. Kwon said.
“If [all 25] are referred for germline testing, you would expect to find the same number of BRCA mutation carriers but with far less resource utilization.”
The remaining 75 are not expected to have a mutation in the tumor, and they may not need to be referred for confirmatory genetic testing unless there is a compelling family history or panel testing reveals a concerning mutation, she explained.
Since a randomized trial to compare these two strategies is not feasible, Dr. Kwon and her colleagues performed the current cost-effectiveness analysis.
The Markov simulation model was used to estimate the number of BRCA mutation carriers from index cases and their first degree relatives, and the number of cancer cases averted among first degree relatives, assuming they would undergo risk-reducing surgery.
“We conducted extensive sensitivity analyses to account for uncertainly around various parameters and we modeled a time horizon of 50 years,” Dr. Kwon noted. “We know that there are approximately 10,000 new [HGSOC] cases diagnosed in the United States every year, and we assumed that for every woman with [HGSOC], there was at least 1 female first-degree relative who would benefit from genetic testing.”
The model showed that applying tumor testing first would lead to a substantial reduction in the number of women undergoing germline mutation testing, but the number of BRCA mutation carriers identified would be comparable with the two strategies – assuming that the sensitivity of tumor testing is less than 100%, she said.
“As expected, the average lifetime costs associated with germline testing would be less than that for tumor testing, and even though you would expect that more first-degree relatives would be identified as BRCA mutation carriers after universal germline testing for index cases, the life expectancy gain for those first-degree relatives is averaged over the entire cohort at risk, and therefore the average incremental gain or benefit was actually quite small,” she said, noting that this yielded the ICER of $127,000 per year of life gained.
Based on this finding, tumor testing would be the preferred strategy, she added.
Sensitivity analysis around the sensitivity and specificity of tumor testing showed that tumor testing would be cost effective if its sensitivity is above 97%, and that tumor testing is cost-effective as long as it costs less than a third of the cost of germline testing – including genetic counseling.
Dr. Kwon has received research funding from AstraZeneca.
sworcester@mdedge.com
SOURCE: Kwon J et al., SGO 2019: Abstract 5.
HONOLULU – Tumor testing for the triage of women with high-grade serous ovarian cancer to confirmatory genetic testing for BRCA mutations appears feasible, according to a cost-effectiveness analysis.
In fact, based on a Markov Monte Carlo simulation model developed to compare a tumor-testing approach with a universal germline testing approach, tumor testing yields an incremental cost-effectiveness ratio (ICER) of $127,000 per year of life gained, Janice S. Kwon, MD, reported at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.
“This is well in excess of [the $50,000 to $100,000 that] would be considered an acceptable threshold in the United States,” said Dr. Kwon of the University of British Columbia, Vancouver, Canada.
“We predict that tumor testing will be a cost-effective method of triage in women with high-grade serous ovarian cancer for confirmatory genetic testing to identify BRCA mutation carriers, assuming high sensitivity and acceptable cost of tumor testing,” she said.
In many areas around the world, germline testing is recommended for all women with high-grade serous ovarian cancer (HGSOC) because they have a 20% chance of carrying a BRCA 1 or 2 mutation.
“However, we all know that the referral rate for genetic testing is far from optimal, and furthermore, there are costs incurred to the healthcare system for resources utilized for genetic counseling and testing,” she said.
Tumor testing for triage is an alternative approach.
“If you consider 100 women with high-grade serous ovarian cancer and follow them through the conventional pathway in which all of them are referred for germline testing, you would expect to find 20 mutation carriers. If you take those same 100 women and apply tumor testing first, then 25 are expected to have a mutation in the tumor, Dr. Kwon said.
“If [all 25] are referred for germline testing, you would expect to find the same number of BRCA mutation carriers but with far less resource utilization.”
The remaining 75 are not expected to have a mutation in the tumor, and they may not need to be referred for confirmatory genetic testing unless there is a compelling family history or panel testing reveals a concerning mutation, she explained.
Since a randomized trial to compare these two strategies is not feasible, Dr. Kwon and her colleagues performed the current cost-effectiveness analysis.
The Markov simulation model was used to estimate the number of BRCA mutation carriers from index cases and their first degree relatives, and the number of cancer cases averted among first degree relatives, assuming they would undergo risk-reducing surgery.
“We conducted extensive sensitivity analyses to account for uncertainly around various parameters and we modeled a time horizon of 50 years,” Dr. Kwon noted. “We know that there are approximately 10,000 new [HGSOC] cases diagnosed in the United States every year, and we assumed that for every woman with [HGSOC], there was at least 1 female first-degree relative who would benefit from genetic testing.”
The model showed that applying tumor testing first would lead to a substantial reduction in the number of women undergoing germline mutation testing, but the number of BRCA mutation carriers identified would be comparable with the two strategies – assuming that the sensitivity of tumor testing is less than 100%, she said.
“As expected, the average lifetime costs associated with germline testing would be less than that for tumor testing, and even though you would expect that more first-degree relatives would be identified as BRCA mutation carriers after universal germline testing for index cases, the life expectancy gain for those first-degree relatives is averaged over the entire cohort at risk, and therefore the average incremental gain or benefit was actually quite small,” she said, noting that this yielded the ICER of $127,000 per year of life gained.
Based on this finding, tumor testing would be the preferred strategy, she added.
Sensitivity analysis around the sensitivity and specificity of tumor testing showed that tumor testing would be cost effective if its sensitivity is above 97%, and that tumor testing is cost-effective as long as it costs less than a third of the cost of germline testing – including genetic counseling.
Dr. Kwon has received research funding from AstraZeneca.
sworcester@mdedge.com
SOURCE: Kwon J et al., SGO 2019: Abstract 5.
REPORTING FROM SGO 2019
MitraClip improves survival and health status for at least 2 years
, based on results from a substudy of the COAPT trial.
Significant improvements seen at 1 month in the TMVr group had waned only slightly by the 2-year time point, reported lead author Suzanne V. Arnold, MD, of Saint Luke’s Mid America Heart Institute and University of Missouri–Kansas City, who presented the findings at the annual meeting of the American College of Cardiology. The study was simultaneously published in the Journal of the American College of Cardiology.
“Considering the previously reported benefits of TMVr on survival and heart failure hospitalization, these health status findings further support the device as a valuable treatment option for heart failure patients with severe secondary mitral regurgitation who remain symptomatic despite maximally-tolerated guideline-directed medical therapy,” Dr. Arnold and her colleagues concluded.
Primary findings from the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial showed that TMVr reduced hospitalizations due to heart failure and all-cause mortality over 2 years, leading the Food and Drug Administration to grant an extended indication to MitraClip. With the present substudy, the investigators sought to learn more about impacts of TMVr on overall health.
“Beyond prolonging survival and reducing hospitalizations, improving patients’ health status (i.e., symptoms, functional status, quality of life) is a key treatment goal of TMVr,” the investigators wrote. “In fact, among older patients with comorbidities and high symptom burden, health status improvement may be of greater importance to patients than improved survival.”
To measure these outcomes, the investigators employed the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the SF-36 health status survey, which they administered to 302 patients in the TMVr group and 312 patients in the standard care group. The primary endpoint was the KCCQ overall summary score (KCCQ-OS), which ranges from 0 to 100, with higher scores indicating better health status.
Across all patients, the average baseline KCCQ-OS score was 52.4 ± 23.0. After 1 month, the average KCCQ-OS score rose 2.1 points in the standard care group, while the TMVr group saw a 16.9-point increase, most heavily through the questionnaire’s quality of life domain. These figures translate to a mean between-group difference of 15.9 points, a value that decreased only slightly after 2 years, to 12.8 points. Further suggesting that TMVr had beneficial and lasting effects, a significantly greater percentage of patients in the TMVr group than in the standard care group were alive with a moderately large health improvement after 2 years (36.4% vs 16.6%; P less than .001).
The study was funded by Abbott Vascular. Several of the investigators reported financial relationships with Abbott as well as Novartis, Bayer, V-wave, Corvia, and others.
SOURCE: Arnold et al. J Am Coll Cardiol. 2019 Mar 17.
, based on results from a substudy of the COAPT trial.
Significant improvements seen at 1 month in the TMVr group had waned only slightly by the 2-year time point, reported lead author Suzanne V. Arnold, MD, of Saint Luke’s Mid America Heart Institute and University of Missouri–Kansas City, who presented the findings at the annual meeting of the American College of Cardiology. The study was simultaneously published in the Journal of the American College of Cardiology.
“Considering the previously reported benefits of TMVr on survival and heart failure hospitalization, these health status findings further support the device as a valuable treatment option for heart failure patients with severe secondary mitral regurgitation who remain symptomatic despite maximally-tolerated guideline-directed medical therapy,” Dr. Arnold and her colleagues concluded.
Primary findings from the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial showed that TMVr reduced hospitalizations due to heart failure and all-cause mortality over 2 years, leading the Food and Drug Administration to grant an extended indication to MitraClip. With the present substudy, the investigators sought to learn more about impacts of TMVr on overall health.
“Beyond prolonging survival and reducing hospitalizations, improving patients’ health status (i.e., symptoms, functional status, quality of life) is a key treatment goal of TMVr,” the investigators wrote. “In fact, among older patients with comorbidities and high symptom burden, health status improvement may be of greater importance to patients than improved survival.”
To measure these outcomes, the investigators employed the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the SF-36 health status survey, which they administered to 302 patients in the TMVr group and 312 patients in the standard care group. The primary endpoint was the KCCQ overall summary score (KCCQ-OS), which ranges from 0 to 100, with higher scores indicating better health status.
Across all patients, the average baseline KCCQ-OS score was 52.4 ± 23.0. After 1 month, the average KCCQ-OS score rose 2.1 points in the standard care group, while the TMVr group saw a 16.9-point increase, most heavily through the questionnaire’s quality of life domain. These figures translate to a mean between-group difference of 15.9 points, a value that decreased only slightly after 2 years, to 12.8 points. Further suggesting that TMVr had beneficial and lasting effects, a significantly greater percentage of patients in the TMVr group than in the standard care group were alive with a moderately large health improvement after 2 years (36.4% vs 16.6%; P less than .001).
The study was funded by Abbott Vascular. Several of the investigators reported financial relationships with Abbott as well as Novartis, Bayer, V-wave, Corvia, and others.
SOURCE: Arnold et al. J Am Coll Cardiol. 2019 Mar 17.
, based on results from a substudy of the COAPT trial.
Significant improvements seen at 1 month in the TMVr group had waned only slightly by the 2-year time point, reported lead author Suzanne V. Arnold, MD, of Saint Luke’s Mid America Heart Institute and University of Missouri–Kansas City, who presented the findings at the annual meeting of the American College of Cardiology. The study was simultaneously published in the Journal of the American College of Cardiology.
“Considering the previously reported benefits of TMVr on survival and heart failure hospitalization, these health status findings further support the device as a valuable treatment option for heart failure patients with severe secondary mitral regurgitation who remain symptomatic despite maximally-tolerated guideline-directed medical therapy,” Dr. Arnold and her colleagues concluded.
Primary findings from the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial showed that TMVr reduced hospitalizations due to heart failure and all-cause mortality over 2 years, leading the Food and Drug Administration to grant an extended indication to MitraClip. With the present substudy, the investigators sought to learn more about impacts of TMVr on overall health.
“Beyond prolonging survival and reducing hospitalizations, improving patients’ health status (i.e., symptoms, functional status, quality of life) is a key treatment goal of TMVr,” the investigators wrote. “In fact, among older patients with comorbidities and high symptom burden, health status improvement may be of greater importance to patients than improved survival.”
To measure these outcomes, the investigators employed the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the SF-36 health status survey, which they administered to 302 patients in the TMVr group and 312 patients in the standard care group. The primary endpoint was the KCCQ overall summary score (KCCQ-OS), which ranges from 0 to 100, with higher scores indicating better health status.
Across all patients, the average baseline KCCQ-OS score was 52.4 ± 23.0. After 1 month, the average KCCQ-OS score rose 2.1 points in the standard care group, while the TMVr group saw a 16.9-point increase, most heavily through the questionnaire’s quality of life domain. These figures translate to a mean between-group difference of 15.9 points, a value that decreased only slightly after 2 years, to 12.8 points. Further suggesting that TMVr had beneficial and lasting effects, a significantly greater percentage of patients in the TMVr group than in the standard care group were alive with a moderately large health improvement after 2 years (36.4% vs 16.6%; P less than .001).
The study was funded by Abbott Vascular. Several of the investigators reported financial relationships with Abbott as well as Novartis, Bayer, V-wave, Corvia, and others.
SOURCE: Arnold et al. J Am Coll Cardiol. 2019 Mar 17.
FROM JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Apple Watch algorithm showed 84% positive predictive value for Afib
, investigators reported at the annual meeting of the American College of Cardiology.
This was a single-arm, prospective, open-label, observational study of unprecedented size and speediness of completion. It included nearly 420,000 self-enrolled adults living in the U.S., with 8 months of monitoring. But despite the study’s flashy size and trendy digital health theme, the researchers were careful not to oversell the findings.
“This study was just meant to be a very, very first step in trying to learn if this kind of technology can help us to prevent stroke. It was not a randomized trial of a public health intervention for screening. This is the first half of the first inning. Rigorous investigation of this technology and its potential use in clinical settings will need to happen. But we do think from a trial and operational standpoint the Apple Heart Study provides a solid foundation upon which further research in digital health can be conducted,” according to Mintu Turakhia, MD, co-principal investigator and an electrophysiologist as well as executive director of the Center for Digital Health at Stanford (Calif.) University, which conducted the study.
The study was conducted virtually. Screening, consent, and data gathering were performed electronically by smartphone. Participants had to have an Apple Watch Series 1, 2, or 3, and an Apple iPhone 5 or more recent model in order to join. The majority of subjects were under age 40, and just 6% were age 65 or older, when the risks of atrial fibrillation (AFib) and stroke are higher. All participants self-reported having no history of AFib nor currently being on anticoagulation.
The study algorithm utilized the Apple Watch’s built-in light sensor technology to opportunistically sample the time interval between pulses when the wearer was still. An irregular time interval triggered a cascade of more frequent sampling. If 5 of 6 samples were irregular within a 48-hour period, the wearer received an irregular rhythm notification along with a prompt to contact a participating physician via telemedicine. The physician could then arrange for an ECG patch to be mailed to the participant, who wore it for up to 7 days before mailing it back for analysis.
Among the key findings in the Apple Heart Study: the irregular pulse notification rate was low overall, at 0.5%, ranging from 0.16% in the under-40 group to 3.2% in subjects age 65 or older. As a result, the study population of particular interest nosedived from an initial 419,297 to the less than 2,100 who received an irregular pulse notification. Of the 658 participants who were subsequently sent an ECG patch, 450 returned it for analysis.
An average of 13 days went by between an irregular pulse notification and ECG patch receipt and activation, so it wasn’t particularly surprising that only 34% of the patches were positive for AFib, since early-stage paroxysmal AFib comes and goes. However, of the 86 subjects who received a new notification of an irregular rhythm while they were wearing a patch, 72 simultaneously showed AFib on their patch. That translates to an 84% positive predictive value for an irregular rhythm notification as an indicator of AFib.
Of the 153 subjects with evidence of AFib on their ECG patch, 20% proved to be in AFib for the full week they wore it. Of those with AFib, 89% had a longest episode of at least 1 hour in duration.
Several discussants expressed reservations about this approach to finding individuals with previously undetected AFib. Jeanne E. Poole, MD, an electrophysiologist and professor of medicine at the University of Washington in Seattle, observed that the question of whether patients with asymptomatic AFib should receive oral anticoagulation therapy is as-yet unanswered and is the focus of ongoing randomized trials. The Apple Heart Study approach, she said, “might lead a lot of patients into being treated unnecessarily or prematurely, or flooding doctors’ offices with a lot of young people.”
Co-principal investigator Marco Perez, MD, an electrophysiologist at Stanford, replied, “Stroke is important, and we all worry about it. But it’s also important that there are other things atrial fibrillation is associated with, like cardiomyopathy and heart failure. So finding atrial fibrillation in a young population might be important. Maybe they don’t need anticoagulation, but maybe there’s something else going on.”
Patrick T. O’Gara, MD, professor of medicine at Harvard University, Boston, was concerned about what he called “the signal-to-noise ratio – the noise that will come in when there is an irregularity detected on the watch that could range from anything from ventricular premature beats to atrial fibrillation.” He is also leery of what he considers to be at this point the excessive hype surrounding direct-to-consumer wearable digital health technology.
“I applaud your circumspection,” he told Dr. Turakhia and Dr. Perez. “I understand very directly from you that these are limited observations. But it’s a good step forward.”
Dr. Perez reported receiving research funding from and serving as a consultant to Apple. Dr. Turakhia reported serving as a consultant to AliveCor and Cardiva Medical.
Their presentation was immediately followed by a related panel discussion titled, “Digital Disruption at Our Doorstep – Implications for Clinicians and Patients.” Session moderator John Rumsfeld, MD, chief innovation officer at the ACC and professor of medicine at the University of Colorado, Denver, kicked things off by observing, “Digital health technology certainly exists. There’ve been billions of dollars invested in digital health. Outside of health care there’s been successful digital transformation of almost every other sector of the economy except for health care. But we deliver care pretty much the same as we have for the past 50 or more years.”
Paul Stoeffels, MD, chief scientific officer at Johnson & Johnson, said physicians and payers want to see evidence of benefit before adopting change. Towards that end, he announced that Johnson & Johnson and Apple are collaborating on a randomized controlled trial called the HEARTLINE study. The active intervention arm in the study involves utilization of the Apple Watch’s irregular pulse notification algorithm, with confirmation of AFib to be achieved using the ECG app incorporated in the latest version of the watch, coupled with a medication adherence app developed by Johnson & Johnson. Enrollment of 150,000 U.S. adults age 65 and older is planned to begin this summer. The study, conducted on a digital platform akin to the Apple Heart Study, will look at the intervention’s impact on rates of stroke, MI, and death as well as AF detection.
Maulik Majmudar, MD, a cardiologist and chief health officer for health and wellness at Amazon, declared, “There’s no doubt in my mind that digital solutions will become a mainstay in our care delivery going forward. The question is really not if, but when.”
He predicted that just as the past two decades have seen the birth of new medical specialties, including hospitalists and cardiovascular intensivists, the next 10 years or so will see the creation of a new field within cardiovascular medicine, whose skilled practitioners might be called ‘digitalists’ – experts in collecting, moving, and safeguarding massive quantities of digital health data.
Robert Califf, MD, vice chancellor for health data science at Duke Health in Durham, N.C., addressed the issue of how society is going to pay for a shift to digital health: “It’s very simple. I don’t see any way that fee-for-service medicine can deal with this. It’s just not possible. If you think we’re going to add on more cost to the system by doing virtual visits, I just do not see that happening. Our solution to the payment system is to get rid of fee-for-service medicine and go to pay-for-value. The minute you’re in pay-for-value, virtual visits and digital information will become the way to do it – to move the treatment and the interaction more to home and less of having people wait in doctors’ offices and spending time in hospitals.”
SOURCE: Turakhia M, ACC 19 NCT03335800
, investigators reported at the annual meeting of the American College of Cardiology.
This was a single-arm, prospective, open-label, observational study of unprecedented size and speediness of completion. It included nearly 420,000 self-enrolled adults living in the U.S., with 8 months of monitoring. But despite the study’s flashy size and trendy digital health theme, the researchers were careful not to oversell the findings.
“This study was just meant to be a very, very first step in trying to learn if this kind of technology can help us to prevent stroke. It was not a randomized trial of a public health intervention for screening. This is the first half of the first inning. Rigorous investigation of this technology and its potential use in clinical settings will need to happen. But we do think from a trial and operational standpoint the Apple Heart Study provides a solid foundation upon which further research in digital health can be conducted,” according to Mintu Turakhia, MD, co-principal investigator and an electrophysiologist as well as executive director of the Center for Digital Health at Stanford (Calif.) University, which conducted the study.
The study was conducted virtually. Screening, consent, and data gathering were performed electronically by smartphone. Participants had to have an Apple Watch Series 1, 2, or 3, and an Apple iPhone 5 or more recent model in order to join. The majority of subjects were under age 40, and just 6% were age 65 or older, when the risks of atrial fibrillation (AFib) and stroke are higher. All participants self-reported having no history of AFib nor currently being on anticoagulation.
The study algorithm utilized the Apple Watch’s built-in light sensor technology to opportunistically sample the time interval between pulses when the wearer was still. An irregular time interval triggered a cascade of more frequent sampling. If 5 of 6 samples were irregular within a 48-hour period, the wearer received an irregular rhythm notification along with a prompt to contact a participating physician via telemedicine. The physician could then arrange for an ECG patch to be mailed to the participant, who wore it for up to 7 days before mailing it back for analysis.
Among the key findings in the Apple Heart Study: the irregular pulse notification rate was low overall, at 0.5%, ranging from 0.16% in the under-40 group to 3.2% in subjects age 65 or older. As a result, the study population of particular interest nosedived from an initial 419,297 to the less than 2,100 who received an irregular pulse notification. Of the 658 participants who were subsequently sent an ECG patch, 450 returned it for analysis.
An average of 13 days went by between an irregular pulse notification and ECG patch receipt and activation, so it wasn’t particularly surprising that only 34% of the patches were positive for AFib, since early-stage paroxysmal AFib comes and goes. However, of the 86 subjects who received a new notification of an irregular rhythm while they were wearing a patch, 72 simultaneously showed AFib on their patch. That translates to an 84% positive predictive value for an irregular rhythm notification as an indicator of AFib.
Of the 153 subjects with evidence of AFib on their ECG patch, 20% proved to be in AFib for the full week they wore it. Of those with AFib, 89% had a longest episode of at least 1 hour in duration.
Several discussants expressed reservations about this approach to finding individuals with previously undetected AFib. Jeanne E. Poole, MD, an electrophysiologist and professor of medicine at the University of Washington in Seattle, observed that the question of whether patients with asymptomatic AFib should receive oral anticoagulation therapy is as-yet unanswered and is the focus of ongoing randomized trials. The Apple Heart Study approach, she said, “might lead a lot of patients into being treated unnecessarily or prematurely, or flooding doctors’ offices with a lot of young people.”
Co-principal investigator Marco Perez, MD, an electrophysiologist at Stanford, replied, “Stroke is important, and we all worry about it. But it’s also important that there are other things atrial fibrillation is associated with, like cardiomyopathy and heart failure. So finding atrial fibrillation in a young population might be important. Maybe they don’t need anticoagulation, but maybe there’s something else going on.”
Patrick T. O’Gara, MD, professor of medicine at Harvard University, Boston, was concerned about what he called “the signal-to-noise ratio – the noise that will come in when there is an irregularity detected on the watch that could range from anything from ventricular premature beats to atrial fibrillation.” He is also leery of what he considers to be at this point the excessive hype surrounding direct-to-consumer wearable digital health technology.
“I applaud your circumspection,” he told Dr. Turakhia and Dr. Perez. “I understand very directly from you that these are limited observations. But it’s a good step forward.”
Dr. Perez reported receiving research funding from and serving as a consultant to Apple. Dr. Turakhia reported serving as a consultant to AliveCor and Cardiva Medical.
Their presentation was immediately followed by a related panel discussion titled, “Digital Disruption at Our Doorstep – Implications for Clinicians and Patients.” Session moderator John Rumsfeld, MD, chief innovation officer at the ACC and professor of medicine at the University of Colorado, Denver, kicked things off by observing, “Digital health technology certainly exists. There’ve been billions of dollars invested in digital health. Outside of health care there’s been successful digital transformation of almost every other sector of the economy except for health care. But we deliver care pretty much the same as we have for the past 50 or more years.”
Paul Stoeffels, MD, chief scientific officer at Johnson & Johnson, said physicians and payers want to see evidence of benefit before adopting change. Towards that end, he announced that Johnson & Johnson and Apple are collaborating on a randomized controlled trial called the HEARTLINE study. The active intervention arm in the study involves utilization of the Apple Watch’s irregular pulse notification algorithm, with confirmation of AFib to be achieved using the ECG app incorporated in the latest version of the watch, coupled with a medication adherence app developed by Johnson & Johnson. Enrollment of 150,000 U.S. adults age 65 and older is planned to begin this summer. The study, conducted on a digital platform akin to the Apple Heart Study, will look at the intervention’s impact on rates of stroke, MI, and death as well as AF detection.
Maulik Majmudar, MD, a cardiologist and chief health officer for health and wellness at Amazon, declared, “There’s no doubt in my mind that digital solutions will become a mainstay in our care delivery going forward. The question is really not if, but when.”
He predicted that just as the past two decades have seen the birth of new medical specialties, including hospitalists and cardiovascular intensivists, the next 10 years or so will see the creation of a new field within cardiovascular medicine, whose skilled practitioners might be called ‘digitalists’ – experts in collecting, moving, and safeguarding massive quantities of digital health data.
Robert Califf, MD, vice chancellor for health data science at Duke Health in Durham, N.C., addressed the issue of how society is going to pay for a shift to digital health: “It’s very simple. I don’t see any way that fee-for-service medicine can deal with this. It’s just not possible. If you think we’re going to add on more cost to the system by doing virtual visits, I just do not see that happening. Our solution to the payment system is to get rid of fee-for-service medicine and go to pay-for-value. The minute you’re in pay-for-value, virtual visits and digital information will become the way to do it – to move the treatment and the interaction more to home and less of having people wait in doctors’ offices and spending time in hospitals.”
SOURCE: Turakhia M, ACC 19 NCT03335800
, investigators reported at the annual meeting of the American College of Cardiology.
This was a single-arm, prospective, open-label, observational study of unprecedented size and speediness of completion. It included nearly 420,000 self-enrolled adults living in the U.S., with 8 months of monitoring. But despite the study’s flashy size and trendy digital health theme, the researchers were careful not to oversell the findings.
“This study was just meant to be a very, very first step in trying to learn if this kind of technology can help us to prevent stroke. It was not a randomized trial of a public health intervention for screening. This is the first half of the first inning. Rigorous investigation of this technology and its potential use in clinical settings will need to happen. But we do think from a trial and operational standpoint the Apple Heart Study provides a solid foundation upon which further research in digital health can be conducted,” according to Mintu Turakhia, MD, co-principal investigator and an electrophysiologist as well as executive director of the Center for Digital Health at Stanford (Calif.) University, which conducted the study.
The study was conducted virtually. Screening, consent, and data gathering were performed electronically by smartphone. Participants had to have an Apple Watch Series 1, 2, or 3, and an Apple iPhone 5 or more recent model in order to join. The majority of subjects were under age 40, and just 6% were age 65 or older, when the risks of atrial fibrillation (AFib) and stroke are higher. All participants self-reported having no history of AFib nor currently being on anticoagulation.
The study algorithm utilized the Apple Watch’s built-in light sensor technology to opportunistically sample the time interval between pulses when the wearer was still. An irregular time interval triggered a cascade of more frequent sampling. If 5 of 6 samples were irregular within a 48-hour period, the wearer received an irregular rhythm notification along with a prompt to contact a participating physician via telemedicine. The physician could then arrange for an ECG patch to be mailed to the participant, who wore it for up to 7 days before mailing it back for analysis.
Among the key findings in the Apple Heart Study: the irregular pulse notification rate was low overall, at 0.5%, ranging from 0.16% in the under-40 group to 3.2% in subjects age 65 or older. As a result, the study population of particular interest nosedived from an initial 419,297 to the less than 2,100 who received an irregular pulse notification. Of the 658 participants who were subsequently sent an ECG patch, 450 returned it for analysis.
An average of 13 days went by between an irregular pulse notification and ECG patch receipt and activation, so it wasn’t particularly surprising that only 34% of the patches were positive for AFib, since early-stage paroxysmal AFib comes and goes. However, of the 86 subjects who received a new notification of an irregular rhythm while they were wearing a patch, 72 simultaneously showed AFib on their patch. That translates to an 84% positive predictive value for an irregular rhythm notification as an indicator of AFib.
Of the 153 subjects with evidence of AFib on their ECG patch, 20% proved to be in AFib for the full week they wore it. Of those with AFib, 89% had a longest episode of at least 1 hour in duration.
Several discussants expressed reservations about this approach to finding individuals with previously undetected AFib. Jeanne E. Poole, MD, an electrophysiologist and professor of medicine at the University of Washington in Seattle, observed that the question of whether patients with asymptomatic AFib should receive oral anticoagulation therapy is as-yet unanswered and is the focus of ongoing randomized trials. The Apple Heart Study approach, she said, “might lead a lot of patients into being treated unnecessarily or prematurely, or flooding doctors’ offices with a lot of young people.”
Co-principal investigator Marco Perez, MD, an electrophysiologist at Stanford, replied, “Stroke is important, and we all worry about it. But it’s also important that there are other things atrial fibrillation is associated with, like cardiomyopathy and heart failure. So finding atrial fibrillation in a young population might be important. Maybe they don’t need anticoagulation, but maybe there’s something else going on.”
Patrick T. O’Gara, MD, professor of medicine at Harvard University, Boston, was concerned about what he called “the signal-to-noise ratio – the noise that will come in when there is an irregularity detected on the watch that could range from anything from ventricular premature beats to atrial fibrillation.” He is also leery of what he considers to be at this point the excessive hype surrounding direct-to-consumer wearable digital health technology.
“I applaud your circumspection,” he told Dr. Turakhia and Dr. Perez. “I understand very directly from you that these are limited observations. But it’s a good step forward.”
Dr. Perez reported receiving research funding from and serving as a consultant to Apple. Dr. Turakhia reported serving as a consultant to AliveCor and Cardiva Medical.
Their presentation was immediately followed by a related panel discussion titled, “Digital Disruption at Our Doorstep – Implications for Clinicians and Patients.” Session moderator John Rumsfeld, MD, chief innovation officer at the ACC and professor of medicine at the University of Colorado, Denver, kicked things off by observing, “Digital health technology certainly exists. There’ve been billions of dollars invested in digital health. Outside of health care there’s been successful digital transformation of almost every other sector of the economy except for health care. But we deliver care pretty much the same as we have for the past 50 or more years.”
Paul Stoeffels, MD, chief scientific officer at Johnson & Johnson, said physicians and payers want to see evidence of benefit before adopting change. Towards that end, he announced that Johnson & Johnson and Apple are collaborating on a randomized controlled trial called the HEARTLINE study. The active intervention arm in the study involves utilization of the Apple Watch’s irregular pulse notification algorithm, with confirmation of AFib to be achieved using the ECG app incorporated in the latest version of the watch, coupled with a medication adherence app developed by Johnson & Johnson. Enrollment of 150,000 U.S. adults age 65 and older is planned to begin this summer. The study, conducted on a digital platform akin to the Apple Heart Study, will look at the intervention’s impact on rates of stroke, MI, and death as well as AF detection.
Maulik Majmudar, MD, a cardiologist and chief health officer for health and wellness at Amazon, declared, “There’s no doubt in my mind that digital solutions will become a mainstay in our care delivery going forward. The question is really not if, but when.”
He predicted that just as the past two decades have seen the birth of new medical specialties, including hospitalists and cardiovascular intensivists, the next 10 years or so will see the creation of a new field within cardiovascular medicine, whose skilled practitioners might be called ‘digitalists’ – experts in collecting, moving, and safeguarding massive quantities of digital health data.
Robert Califf, MD, vice chancellor for health data science at Duke Health in Durham, N.C., addressed the issue of how society is going to pay for a shift to digital health: “It’s very simple. I don’t see any way that fee-for-service medicine can deal with this. It’s just not possible. If you think we’re going to add on more cost to the system by doing virtual visits, I just do not see that happening. Our solution to the payment system is to get rid of fee-for-service medicine and go to pay-for-value. The minute you’re in pay-for-value, virtual visits and digital information will become the way to do it – to move the treatment and the interaction more to home and less of having people wait in doctors’ offices and spending time in hospitals.”
SOURCE: Turakhia M, ACC 19 NCT03335800
REPORTING FROM ACC 19
ENGOT-OV16/NOVA trial: Analysis shows improved TWiST with niraparib
HONOLULU – Patients with recurrent ovarian cancer who were treated with niraparib maintenance therapy experienced more time without symptoms or toxicities (TWiST) than did controls, according to an analysis of data from the pivotal phase 3 ENGOT-OV16/NOVA trial.
The mean 20-year TWiST benefit – defined in the current analysis as progression-free survival (PFS) without toxicity due to grade 2 or greater nausea, vomiting, or fatigue – was fourfold greater among women who were carriers of the 138 germline BRCA mutation (gBRCAmut) and received treatment with the poly(adenosine diphosphate-ribose) polymerase (PARP) 1/2 inhibitor than among the 65 similar women who received placebo. The TWiST benefit was about twofold greater among the 234 non-gBRCAmut carriers treated with niraparib than among the 116 who received placebo, Ursula A. Matulonis, MD, reported at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.
The 10- and 5-year estimated mean improvement in TWiST in the groups also showed “very proportional effects that are similar to the 20-year data,” said Dr. Matulonis, chief of the division of gynecologic oncology at Dana-Farber Cancer Institute, and a professor of medicine at Harvard Medical School, Boston.
TWiSt is an “established methodology that partitions PFS ... based on time with toxicity and time without progression or toxicity." Mean TWiST is calculated as mean PFS minus mean toxicity, she explained.
In the ENGOT-OV16/NOVA study, women with recurrent ovarian cancer who received niraparib for maintenance after platinum-based therapy had significantly longer PFS, compared with patients who received placebo (21.0 vs. 5.5 months in gBRCAmut patients and 9.3 vs. 3.9 months in the non-gBRCAmut patients, respectively), she said (N Engl J Med 2016;75:2154-2164).
Quality of life (QOL) remained stable throughout niraparib treatment, according to another analysis of data from the trial published in 2018. (Lancet Oncology. Aug 1 2018;19[8]:1117-25).
The current analysis looked more closely at QOL by estimating mean TWiST in the treatment vs. control groups, she explained.
“Survival curves were used to extrapolate PFS ... over 20 years for both the gBRCAmut and non-gBRCAmut cohorts. The 20-year period was based on ovarian cancer clinical expert opinion and the biologic plausibility that patients could be on PARP inhibitors for a long period of time,” she said.
Time of toxicity was estimated based on the number of days patients experienced toxic effects due to grade 2 or higher nausea, vomiting, or fatigue during the NOVA trial.
The PFS benefit in treated vs. control subjects, respectively, was 3.23 years and 1.33 years in the gBRCAmut and non-gBRCAmut cohorts, and the mean toxicity time was 0.28 years and 0.10 years, for a mean TWiST benefit of 2.95 and 1.34 years, respectively.
“This TWiST benefit means that patients treated with niraparib experienced more progression-free time without symptoms or toxicities due to nausea, vomiting, or fatigue, compared with patients receiving placebo,” she concluded.
Dr. Matulonis is a consultant for 2X Oncology, Merck, Mersana, Fujifilm, Immunogen, and Geneos.
sworcester@mdedge.com
SOURCE: Matulonis U et al., SGO 2019: Abstract 1.
HONOLULU – Patients with recurrent ovarian cancer who were treated with niraparib maintenance therapy experienced more time without symptoms or toxicities (TWiST) than did controls, according to an analysis of data from the pivotal phase 3 ENGOT-OV16/NOVA trial.
The mean 20-year TWiST benefit – defined in the current analysis as progression-free survival (PFS) without toxicity due to grade 2 or greater nausea, vomiting, or fatigue – was fourfold greater among women who were carriers of the 138 germline BRCA mutation (gBRCAmut) and received treatment with the poly(adenosine diphosphate-ribose) polymerase (PARP) 1/2 inhibitor than among the 65 similar women who received placebo. The TWiST benefit was about twofold greater among the 234 non-gBRCAmut carriers treated with niraparib than among the 116 who received placebo, Ursula A. Matulonis, MD, reported at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.
The 10- and 5-year estimated mean improvement in TWiST in the groups also showed “very proportional effects that are similar to the 20-year data,” said Dr. Matulonis, chief of the division of gynecologic oncology at Dana-Farber Cancer Institute, and a professor of medicine at Harvard Medical School, Boston.
TWiSt is an “established methodology that partitions PFS ... based on time with toxicity and time without progression or toxicity." Mean TWiST is calculated as mean PFS minus mean toxicity, she explained.
In the ENGOT-OV16/NOVA study, women with recurrent ovarian cancer who received niraparib for maintenance after platinum-based therapy had significantly longer PFS, compared with patients who received placebo (21.0 vs. 5.5 months in gBRCAmut patients and 9.3 vs. 3.9 months in the non-gBRCAmut patients, respectively), she said (N Engl J Med 2016;75:2154-2164).
Quality of life (QOL) remained stable throughout niraparib treatment, according to another analysis of data from the trial published in 2018. (Lancet Oncology. Aug 1 2018;19[8]:1117-25).
The current analysis looked more closely at QOL by estimating mean TWiST in the treatment vs. control groups, she explained.
“Survival curves were used to extrapolate PFS ... over 20 years for both the gBRCAmut and non-gBRCAmut cohorts. The 20-year period was based on ovarian cancer clinical expert opinion and the biologic plausibility that patients could be on PARP inhibitors for a long period of time,” she said.
Time of toxicity was estimated based on the number of days patients experienced toxic effects due to grade 2 or higher nausea, vomiting, or fatigue during the NOVA trial.
The PFS benefit in treated vs. control subjects, respectively, was 3.23 years and 1.33 years in the gBRCAmut and non-gBRCAmut cohorts, and the mean toxicity time was 0.28 years and 0.10 years, for a mean TWiST benefit of 2.95 and 1.34 years, respectively.
“This TWiST benefit means that patients treated with niraparib experienced more progression-free time without symptoms or toxicities due to nausea, vomiting, or fatigue, compared with patients receiving placebo,” she concluded.
Dr. Matulonis is a consultant for 2X Oncology, Merck, Mersana, Fujifilm, Immunogen, and Geneos.
sworcester@mdedge.com
SOURCE: Matulonis U et al., SGO 2019: Abstract 1.
HONOLULU – Patients with recurrent ovarian cancer who were treated with niraparib maintenance therapy experienced more time without symptoms or toxicities (TWiST) than did controls, according to an analysis of data from the pivotal phase 3 ENGOT-OV16/NOVA trial.
The mean 20-year TWiST benefit – defined in the current analysis as progression-free survival (PFS) without toxicity due to grade 2 or greater nausea, vomiting, or fatigue – was fourfold greater among women who were carriers of the 138 germline BRCA mutation (gBRCAmut) and received treatment with the poly(adenosine diphosphate-ribose) polymerase (PARP) 1/2 inhibitor than among the 65 similar women who received placebo. The TWiST benefit was about twofold greater among the 234 non-gBRCAmut carriers treated with niraparib than among the 116 who received placebo, Ursula A. Matulonis, MD, reported at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.
The 10- and 5-year estimated mean improvement in TWiST in the groups also showed “very proportional effects that are similar to the 20-year data,” said Dr. Matulonis, chief of the division of gynecologic oncology at Dana-Farber Cancer Institute, and a professor of medicine at Harvard Medical School, Boston.
TWiSt is an “established methodology that partitions PFS ... based on time with toxicity and time without progression or toxicity." Mean TWiST is calculated as mean PFS minus mean toxicity, she explained.
In the ENGOT-OV16/NOVA study, women with recurrent ovarian cancer who received niraparib for maintenance after platinum-based therapy had significantly longer PFS, compared with patients who received placebo (21.0 vs. 5.5 months in gBRCAmut patients and 9.3 vs. 3.9 months in the non-gBRCAmut patients, respectively), she said (N Engl J Med 2016;75:2154-2164).
Quality of life (QOL) remained stable throughout niraparib treatment, according to another analysis of data from the trial published in 2018. (Lancet Oncology. Aug 1 2018;19[8]:1117-25).
The current analysis looked more closely at QOL by estimating mean TWiST in the treatment vs. control groups, she explained.
“Survival curves were used to extrapolate PFS ... over 20 years for both the gBRCAmut and non-gBRCAmut cohorts. The 20-year period was based on ovarian cancer clinical expert opinion and the biologic plausibility that patients could be on PARP inhibitors for a long period of time,” she said.
Time of toxicity was estimated based on the number of days patients experienced toxic effects due to grade 2 or higher nausea, vomiting, or fatigue during the NOVA trial.
The PFS benefit in treated vs. control subjects, respectively, was 3.23 years and 1.33 years in the gBRCAmut and non-gBRCAmut cohorts, and the mean toxicity time was 0.28 years and 0.10 years, for a mean TWiST benefit of 2.95 and 1.34 years, respectively.
“This TWiST benefit means that patients treated with niraparib experienced more progression-free time without symptoms or toxicities due to nausea, vomiting, or fatigue, compared with patients receiving placebo,” she concluded.
Dr. Matulonis is a consultant for 2X Oncology, Merck, Mersana, Fujifilm, Immunogen, and Geneos.
sworcester@mdedge.com
SOURCE: Matulonis U et al., SGO 2019: Abstract 1.
REPORTING FROM SGO 2019
Policy statement on drowning highlights high-risk groups
Wider availability of low-cost swim lessons could reduce drowning risk in children over 1 year old, but such lessons are only one component of reducing drowning risk and cannot “drown-proof” children, who should still be fully supervised around water, according to a new policy statement from the American Academy of Pediatrics.
These strategies include barriers, supervision, swim lessons, use of life jackets, and training in cardiopulmonary resuscitation (CPR). Parents should be advised to restrict unsupervised access to pools and other bodies of water, as well as understand the risks of substance use around water, Sarah A. Denny, MD, and the members of the AAP’s Council on Injury, Violence, and Poison Prevention, wrote.
The committee made five major recommendations for pediatricians:
• Recognize high-risk groups and leading causes of drowning in their area and customize advice to parents about drowning risk accordingly.
• Pay special attention to needs of children with medical conditions that increase drowning risk, such as seizure disorders, autism spectrum disorder and cardiac arrhythmias, and advise uninterrupted supervision for these children even in baths.
• Inform parents and children of the increased risk of drowning with substance use, especially for teen boys.
• Discuss water skill levels with parents and children to avoid either overestimating a youth’s competency.
• Encourage CPR training in high schools.
Accidental drowning rates have declined from 2.7 per 100,000 children in 1985 to 1.1 per 100,000 children in 2017, yet drowning remains the top cause of injury death among children ages 1-4 years, reported Dr. Denny, of Nationwide Hospital in Columbus, Ohio, and her colleagues (Pediatrics. March 15, 2019). For those ages 5-19 years old, drowning is the third leading cause of accidental death.
Nearly 1,000 children and adolescents under 20 years old die from drowning each year. An estimated 8,700 others went to the emergency department for drowning-related incidents in 2017. Of these children, 25% required admission or additional care.
“Most victims of nonfatal drowning recover fully with no neurologic deficits, but severe long-term neurologic deficits are seen with extended submersion times (over 6 minutes), prolonged resuscitation efforts, and lack of early bystander-initiated cardiopulmonary resuscitation (CPR),” the committee wrote.
Children at highest drowning risk include toddlers and teen boys of all races/ethnicities as well as black and Native American/Alaska Native children. Black male teens had the highest overall rates, 4 drowning deaths per 100,000 children, for 2013-2017.
Among those aged 4 years and under, drowning risk was primarily related to the lack of barriers to prevent unanticipated, unsupervised access to water, including swimming pools, hot tubs and spas, bathtubs, natural bodies of water, and standing water in homes (buckets, tubs, and toilets), the committee wrote.
Teens are most likely to die in natural water settings, such as ponds, rivers, lakes and sea water. “The increased risk for fatal drowning in adolescents can be attributed to multiple factors, including overestimation of skills, underestimation of dangerous situations, engaging in high-risk and impulsive behaviors, and substance use,” particularly alcohol consumption, according to the statement.
Children with seizure disorders have up to a 10-times greater risk of drowning, and therefore require constant supervision around water. Whenever possible, children with seizure disorders should shower instead of bathe and swim only at locations where there is a lifeguard.
Similarly, supervision is essential for children with autism spectrum disorder, especially those under age 15 and with greater intellectual disability. Wandering is the most commonly reported behavior leading to drowning, accounting for nearly 74% of fatal drowning incidents among children with autism.
The committee also recommended four community advocacy activities:
• Actively work with legislators to develop policy aimed at reducing the risk of drowning, such as pool/water fencing requirements and laws related to boating, life jacket use, EMS systems and overall water safety.
• Use “non-fatal drowning” — not “near drowning” — to describe drowning incidents that do not result in death and inform parents that “dry drowning” and “secondary drowning” are not medically accurate terms.
• Work with community groups to ensure life jackets are accessible for all people at pools and boating sites.
• Encourage, identify and support “high-quality, culturally sensitive, and affordable” swim lesson programs, particularly for children in low-income, disability or other high-risk groups.“Socioeconomic and cultural disparities in water safety knowledge, swimming skills and drowning risk can be addressed through “community-based programs targeting high-risk groups by providing free or low-cost swim lessons, developing special programs that address cultural concerns as well as swim lessons for youth with developmental disabilities, and changing pool policies to meet the needs of specific communities,” the committee wrote.
The statement did not use external funding, and the authors reported no financial conflicts.
SOURCE: Denny SA et al. Pediatrics.
Wider availability of low-cost swim lessons could reduce drowning risk in children over 1 year old, but such lessons are only one component of reducing drowning risk and cannot “drown-proof” children, who should still be fully supervised around water, according to a new policy statement from the American Academy of Pediatrics.
These strategies include barriers, supervision, swim lessons, use of life jackets, and training in cardiopulmonary resuscitation (CPR). Parents should be advised to restrict unsupervised access to pools and other bodies of water, as well as understand the risks of substance use around water, Sarah A. Denny, MD, and the members of the AAP’s Council on Injury, Violence, and Poison Prevention, wrote.
The committee made five major recommendations for pediatricians:
• Recognize high-risk groups and leading causes of drowning in their area and customize advice to parents about drowning risk accordingly.
• Pay special attention to needs of children with medical conditions that increase drowning risk, such as seizure disorders, autism spectrum disorder and cardiac arrhythmias, and advise uninterrupted supervision for these children even in baths.
• Inform parents and children of the increased risk of drowning with substance use, especially for teen boys.
• Discuss water skill levels with parents and children to avoid either overestimating a youth’s competency.
• Encourage CPR training in high schools.
Accidental drowning rates have declined from 2.7 per 100,000 children in 1985 to 1.1 per 100,000 children in 2017, yet drowning remains the top cause of injury death among children ages 1-4 years, reported Dr. Denny, of Nationwide Hospital in Columbus, Ohio, and her colleagues (Pediatrics. March 15, 2019). For those ages 5-19 years old, drowning is the third leading cause of accidental death.
Nearly 1,000 children and adolescents under 20 years old die from drowning each year. An estimated 8,700 others went to the emergency department for drowning-related incidents in 2017. Of these children, 25% required admission or additional care.
“Most victims of nonfatal drowning recover fully with no neurologic deficits, but severe long-term neurologic deficits are seen with extended submersion times (over 6 minutes), prolonged resuscitation efforts, and lack of early bystander-initiated cardiopulmonary resuscitation (CPR),” the committee wrote.
Children at highest drowning risk include toddlers and teen boys of all races/ethnicities as well as black and Native American/Alaska Native children. Black male teens had the highest overall rates, 4 drowning deaths per 100,000 children, for 2013-2017.
Among those aged 4 years and under, drowning risk was primarily related to the lack of barriers to prevent unanticipated, unsupervised access to water, including swimming pools, hot tubs and spas, bathtubs, natural bodies of water, and standing water in homes (buckets, tubs, and toilets), the committee wrote.
Teens are most likely to die in natural water settings, such as ponds, rivers, lakes and sea water. “The increased risk for fatal drowning in adolescents can be attributed to multiple factors, including overestimation of skills, underestimation of dangerous situations, engaging in high-risk and impulsive behaviors, and substance use,” particularly alcohol consumption, according to the statement.
Children with seizure disorders have up to a 10-times greater risk of drowning, and therefore require constant supervision around water. Whenever possible, children with seizure disorders should shower instead of bathe and swim only at locations where there is a lifeguard.
Similarly, supervision is essential for children with autism spectrum disorder, especially those under age 15 and with greater intellectual disability. Wandering is the most commonly reported behavior leading to drowning, accounting for nearly 74% of fatal drowning incidents among children with autism.
The committee also recommended four community advocacy activities:
• Actively work with legislators to develop policy aimed at reducing the risk of drowning, such as pool/water fencing requirements and laws related to boating, life jacket use, EMS systems and overall water safety.
• Use “non-fatal drowning” — not “near drowning” — to describe drowning incidents that do not result in death and inform parents that “dry drowning” and “secondary drowning” are not medically accurate terms.
• Work with community groups to ensure life jackets are accessible for all people at pools and boating sites.
• Encourage, identify and support “high-quality, culturally sensitive, and affordable” swim lesson programs, particularly for children in low-income, disability or other high-risk groups.“Socioeconomic and cultural disparities in water safety knowledge, swimming skills and drowning risk can be addressed through “community-based programs targeting high-risk groups by providing free or low-cost swim lessons, developing special programs that address cultural concerns as well as swim lessons for youth with developmental disabilities, and changing pool policies to meet the needs of specific communities,” the committee wrote.
The statement did not use external funding, and the authors reported no financial conflicts.
SOURCE: Denny SA et al. Pediatrics.
Wider availability of low-cost swim lessons could reduce drowning risk in children over 1 year old, but such lessons are only one component of reducing drowning risk and cannot “drown-proof” children, who should still be fully supervised around water, according to a new policy statement from the American Academy of Pediatrics.
These strategies include barriers, supervision, swim lessons, use of life jackets, and training in cardiopulmonary resuscitation (CPR). Parents should be advised to restrict unsupervised access to pools and other bodies of water, as well as understand the risks of substance use around water, Sarah A. Denny, MD, and the members of the AAP’s Council on Injury, Violence, and Poison Prevention, wrote.
The committee made five major recommendations for pediatricians:
• Recognize high-risk groups and leading causes of drowning in their area and customize advice to parents about drowning risk accordingly.
• Pay special attention to needs of children with medical conditions that increase drowning risk, such as seizure disorders, autism spectrum disorder and cardiac arrhythmias, and advise uninterrupted supervision for these children even in baths.
• Inform parents and children of the increased risk of drowning with substance use, especially for teen boys.
• Discuss water skill levels with parents and children to avoid either overestimating a youth’s competency.
• Encourage CPR training in high schools.
Accidental drowning rates have declined from 2.7 per 100,000 children in 1985 to 1.1 per 100,000 children in 2017, yet drowning remains the top cause of injury death among children ages 1-4 years, reported Dr. Denny, of Nationwide Hospital in Columbus, Ohio, and her colleagues (Pediatrics. March 15, 2019). For those ages 5-19 years old, drowning is the third leading cause of accidental death.
Nearly 1,000 children and adolescents under 20 years old die from drowning each year. An estimated 8,700 others went to the emergency department for drowning-related incidents in 2017. Of these children, 25% required admission or additional care.
“Most victims of nonfatal drowning recover fully with no neurologic deficits, but severe long-term neurologic deficits are seen with extended submersion times (over 6 minutes), prolonged resuscitation efforts, and lack of early bystander-initiated cardiopulmonary resuscitation (CPR),” the committee wrote.
Children at highest drowning risk include toddlers and teen boys of all races/ethnicities as well as black and Native American/Alaska Native children. Black male teens had the highest overall rates, 4 drowning deaths per 100,000 children, for 2013-2017.
Among those aged 4 years and under, drowning risk was primarily related to the lack of barriers to prevent unanticipated, unsupervised access to water, including swimming pools, hot tubs and spas, bathtubs, natural bodies of water, and standing water in homes (buckets, tubs, and toilets), the committee wrote.
Teens are most likely to die in natural water settings, such as ponds, rivers, lakes and sea water. “The increased risk for fatal drowning in adolescents can be attributed to multiple factors, including overestimation of skills, underestimation of dangerous situations, engaging in high-risk and impulsive behaviors, and substance use,” particularly alcohol consumption, according to the statement.
Children with seizure disorders have up to a 10-times greater risk of drowning, and therefore require constant supervision around water. Whenever possible, children with seizure disorders should shower instead of bathe and swim only at locations where there is a lifeguard.
Similarly, supervision is essential for children with autism spectrum disorder, especially those under age 15 and with greater intellectual disability. Wandering is the most commonly reported behavior leading to drowning, accounting for nearly 74% of fatal drowning incidents among children with autism.
The committee also recommended four community advocacy activities:
• Actively work with legislators to develop policy aimed at reducing the risk of drowning, such as pool/water fencing requirements and laws related to boating, life jacket use, EMS systems and overall water safety.
• Use “non-fatal drowning” — not “near drowning” — to describe drowning incidents that do not result in death and inform parents that “dry drowning” and “secondary drowning” are not medically accurate terms.
• Work with community groups to ensure life jackets are accessible for all people at pools and boating sites.
• Encourage, identify and support “high-quality, culturally sensitive, and affordable” swim lesson programs, particularly for children in low-income, disability or other high-risk groups.“Socioeconomic and cultural disparities in water safety knowledge, swimming skills and drowning risk can be addressed through “community-based programs targeting high-risk groups by providing free or low-cost swim lessons, developing special programs that address cultural concerns as well as swim lessons for youth with developmental disabilities, and changing pool policies to meet the needs of specific communities,” the committee wrote.
The statement did not use external funding, and the authors reported no financial conflicts.
SOURCE: Denny SA et al. Pediatrics.
FROM PEDIATRICS
Apple Watch algorithm brings wearables closer to clinical practice
NEW ORLEANS – , Matthew W. Martinez, MD, medical director of the Sports Cardiology and Hypertrophic Cardiomyopathy Center at the Lehigh Valley Health Network in Allentown, Pa., said in a video interview.
The Apple Heart Study, presented at the annual meeting of the American College of Cardiology, evaluated a mobile app that uses the watch’s existing light sensor technology to detect subtle changes that might indicate an arrhythmia.
The Apple Watch generates a tachogram, which is a plot of time between heart beats. If an abnormal tachogram occurs five out of six times, they are analyzed by an algorithm and sent to the Apple Watch.
The positive predictive value for the tachogram was 71%, and the positive predictive value for the notification was 84%.
Dr. Martinez, who is lead cardiologist for U.S. Major League Soccer and is also heavily involved with the National Football League, said that the study helps clinicians understand the utility of wearable technology.
His take home from the study is that, when people are notified by their watch, they should notify their health care provider, and the provider should take it seriously.
Dr. Martinez was not involved in the Apple Heart Study, and had no relevant disclosures.
bjancin@mdedge.com
NEW ORLEANS – , Matthew W. Martinez, MD, medical director of the Sports Cardiology and Hypertrophic Cardiomyopathy Center at the Lehigh Valley Health Network in Allentown, Pa., said in a video interview.
The Apple Heart Study, presented at the annual meeting of the American College of Cardiology, evaluated a mobile app that uses the watch’s existing light sensor technology to detect subtle changes that might indicate an arrhythmia.
The Apple Watch generates a tachogram, which is a plot of time between heart beats. If an abnormal tachogram occurs five out of six times, they are analyzed by an algorithm and sent to the Apple Watch.
The positive predictive value for the tachogram was 71%, and the positive predictive value for the notification was 84%.
Dr. Martinez, who is lead cardiologist for U.S. Major League Soccer and is also heavily involved with the National Football League, said that the study helps clinicians understand the utility of wearable technology.
His take home from the study is that, when people are notified by their watch, they should notify their health care provider, and the provider should take it seriously.
Dr. Martinez was not involved in the Apple Heart Study, and had no relevant disclosures.
bjancin@mdedge.com
NEW ORLEANS – , Matthew W. Martinez, MD, medical director of the Sports Cardiology and Hypertrophic Cardiomyopathy Center at the Lehigh Valley Health Network in Allentown, Pa., said in a video interview.
The Apple Heart Study, presented at the annual meeting of the American College of Cardiology, evaluated a mobile app that uses the watch’s existing light sensor technology to detect subtle changes that might indicate an arrhythmia.
The Apple Watch generates a tachogram, which is a plot of time between heart beats. If an abnormal tachogram occurs five out of six times, they are analyzed by an algorithm and sent to the Apple Watch.
The positive predictive value for the tachogram was 71%, and the positive predictive value for the notification was 84%.
Dr. Martinez, who is lead cardiologist for U.S. Major League Soccer and is also heavily involved with the National Football League, said that the study helps clinicians understand the utility of wearable technology.
His take home from the study is that, when people are notified by their watch, they should notify their health care provider, and the provider should take it seriously.
Dr. Martinez was not involved in the Apple Heart Study, and had no relevant disclosures.
bjancin@mdedge.com
REPORTING FROM ACC 19
Real-world efficacy with intravascular lithotripsy
washington, dc – A real-world case series suggests intravascular lithotripsy (IVL) is safe and effective when used selectively to treat coronary arterial calcifications, according to data presented at the 2019 Transcatheter Cardiovascular Therapeutics (CRT) meeting.
Relative to other options, “IVL offers a more controlled means of calcium modification and it avoids the no-reflow phenomenon common to atherectomy in patients with a high calcium burden,” reported Julian Yeoh, MBBS, an interventional cardiologist affiliated with King’s College Hospital, London, UK.
On the basis of the DISRUPT CAD study, presented at the 2016 TCT meeting, IVL was approved in Europe for calcified coronary artery disease in May 2018. The Shockwave IVL device (Shockwave Medical) is currently approved in the U.S. only for treatment of calcified lesions associated with peripheral artery disease (PAD).
In what was characterized as a “real-world series,” 14 procedures were performed at Dr. Yeoh’s institution as part of a clinical study, but 40 procedures were completed on an all-comer basis. Many were performed for indications, such as multivessel disease, that would have been excluded from the DISRUPT CAD study.
“We included elderly patients, patients in cardiogenic shock, and patients with chronic total occlusions,” Dr. Yeoh reported. Presenting specific cases, he described using IVL to permit venous access for a transcatheter aortic valve replacement (TAVR), a failed rotational atherectomy, and to salvage a percutaneous angioplasty thwarted by residual calcium calcification.
“Total procedural success in this series was 91% with 100% facilitation of stent delivery,” Dr. Yeoh said. “There have been no cases of coronary perforation and no reflow or 30-day target lesion failure.”
In this series, the mean age of the patients was 75.9 years. On optical coherence tomography (OCT), which was employed in about half of the cases, the mean residual stenosis was approximately 20%.
IVL involves passing a balloon into the target lesion with the same guidewire used for other percutaneous interventions. Once in position, sonic pressure waves fracture the calcium deposit “with no injury to the intimal soft tissue,” according to Dr. Yeoh, who said that there were no serious adverse events associated with IVL in the series he presented.
In DISRUPT CAD, which enrolled 60 patients, procedural success was 95% with a reduction in mean stenosis from 68.1% to 13.1%. The rate of major adverse cardiovascular event (MACE) events was 5% at 30 days.
While DISRUPT CAD-II is an on-going post-market registry collecting data in Europe and other areas of the world where IVL is approved for treatment of coronary artery disease, a pivotal trial called DISRUPT CAD III has been launched to gain an indication for treatment of coronary calcifications in the U.S. The prospective global trial has a planned enrollment of nearly 400 patients with expected completion in August 2020.
SOURCE: Yeoh J et al. 2019 Cardiovascular Research Technologies (CRT) Meeting abstract.
washington, dc – A real-world case series suggests intravascular lithotripsy (IVL) is safe and effective when used selectively to treat coronary arterial calcifications, according to data presented at the 2019 Transcatheter Cardiovascular Therapeutics (CRT) meeting.
Relative to other options, “IVL offers a more controlled means of calcium modification and it avoids the no-reflow phenomenon common to atherectomy in patients with a high calcium burden,” reported Julian Yeoh, MBBS, an interventional cardiologist affiliated with King’s College Hospital, London, UK.
On the basis of the DISRUPT CAD study, presented at the 2016 TCT meeting, IVL was approved in Europe for calcified coronary artery disease in May 2018. The Shockwave IVL device (Shockwave Medical) is currently approved in the U.S. only for treatment of calcified lesions associated with peripheral artery disease (PAD).
In what was characterized as a “real-world series,” 14 procedures were performed at Dr. Yeoh’s institution as part of a clinical study, but 40 procedures were completed on an all-comer basis. Many were performed for indications, such as multivessel disease, that would have been excluded from the DISRUPT CAD study.
“We included elderly patients, patients in cardiogenic shock, and patients with chronic total occlusions,” Dr. Yeoh reported. Presenting specific cases, he described using IVL to permit venous access for a transcatheter aortic valve replacement (TAVR), a failed rotational atherectomy, and to salvage a percutaneous angioplasty thwarted by residual calcium calcification.
“Total procedural success in this series was 91% with 100% facilitation of stent delivery,” Dr. Yeoh said. “There have been no cases of coronary perforation and no reflow or 30-day target lesion failure.”
In this series, the mean age of the patients was 75.9 years. On optical coherence tomography (OCT), which was employed in about half of the cases, the mean residual stenosis was approximately 20%.
IVL involves passing a balloon into the target lesion with the same guidewire used for other percutaneous interventions. Once in position, sonic pressure waves fracture the calcium deposit “with no injury to the intimal soft tissue,” according to Dr. Yeoh, who said that there were no serious adverse events associated with IVL in the series he presented.
In DISRUPT CAD, which enrolled 60 patients, procedural success was 95% with a reduction in mean stenosis from 68.1% to 13.1%. The rate of major adverse cardiovascular event (MACE) events was 5% at 30 days.
While DISRUPT CAD-II is an on-going post-market registry collecting data in Europe and other areas of the world where IVL is approved for treatment of coronary artery disease, a pivotal trial called DISRUPT CAD III has been launched to gain an indication for treatment of coronary calcifications in the U.S. The prospective global trial has a planned enrollment of nearly 400 patients with expected completion in August 2020.
SOURCE: Yeoh J et al. 2019 Cardiovascular Research Technologies (CRT) Meeting abstract.
washington, dc – A real-world case series suggests intravascular lithotripsy (IVL) is safe and effective when used selectively to treat coronary arterial calcifications, according to data presented at the 2019 Transcatheter Cardiovascular Therapeutics (CRT) meeting.
Relative to other options, “IVL offers a more controlled means of calcium modification and it avoids the no-reflow phenomenon common to atherectomy in patients with a high calcium burden,” reported Julian Yeoh, MBBS, an interventional cardiologist affiliated with King’s College Hospital, London, UK.
On the basis of the DISRUPT CAD study, presented at the 2016 TCT meeting, IVL was approved in Europe for calcified coronary artery disease in May 2018. The Shockwave IVL device (Shockwave Medical) is currently approved in the U.S. only for treatment of calcified lesions associated with peripheral artery disease (PAD).
In what was characterized as a “real-world series,” 14 procedures were performed at Dr. Yeoh’s institution as part of a clinical study, but 40 procedures were completed on an all-comer basis. Many were performed for indications, such as multivessel disease, that would have been excluded from the DISRUPT CAD study.
“We included elderly patients, patients in cardiogenic shock, and patients with chronic total occlusions,” Dr. Yeoh reported. Presenting specific cases, he described using IVL to permit venous access for a transcatheter aortic valve replacement (TAVR), a failed rotational atherectomy, and to salvage a percutaneous angioplasty thwarted by residual calcium calcification.
“Total procedural success in this series was 91% with 100% facilitation of stent delivery,” Dr. Yeoh said. “There have been no cases of coronary perforation and no reflow or 30-day target lesion failure.”
In this series, the mean age of the patients was 75.9 years. On optical coherence tomography (OCT), which was employed in about half of the cases, the mean residual stenosis was approximately 20%.
IVL involves passing a balloon into the target lesion with the same guidewire used for other percutaneous interventions. Once in position, sonic pressure waves fracture the calcium deposit “with no injury to the intimal soft tissue,” according to Dr. Yeoh, who said that there were no serious adverse events associated with IVL in the series he presented.
In DISRUPT CAD, which enrolled 60 patients, procedural success was 95% with a reduction in mean stenosis from 68.1% to 13.1%. The rate of major adverse cardiovascular event (MACE) events was 5% at 30 days.
While DISRUPT CAD-II is an on-going post-market registry collecting data in Europe and other areas of the world where IVL is approved for treatment of coronary artery disease, a pivotal trial called DISRUPT CAD III has been launched to gain an indication for treatment of coronary calcifications in the U.S. The prospective global trial has a planned enrollment of nearly 400 patients with expected completion in August 2020.
SOURCE: Yeoh J et al. 2019 Cardiovascular Research Technologies (CRT) Meeting abstract.
REPORTING FROM CRT 2019
Financial assistance programs may speed treatment for cervical cancer
HONOLULU – Financial assistance programs may help lower-income cervical cancer patients complete treatment in a timely manner, according to research presented at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.
In a retrospective study, lower-income patients who used financial assistance programs were able to complete treatment for cervical cancer in a similar timeframe as higher-income patients.
Lower-income patients who registered for disability benefits saw a significant improvement in time to treatment completion.
Additionally, there was a trend toward improved time to treatment completion among lower-income patients who registered for federally funded breast and cervical cancer treatment.
“Identification of patients who qualify for disability and/or breast/cervical cancer Medicaid, and providing assistance for registration in these programs may help them complete therapy in a more appropriate timeframe,” said study investigator Jessica Gillen, MD, of The University of Oklahoma in Oklahoma City.
Dr. Gillen and her colleagues conducted this single-center, retrospective study of patients with squamous cell, adenocarcinoma, or adenosquamous cancer of the cervix.
The investigators identified 116 evaluable patients who received chemoradiation from January 1, 2015, to July 31, 2018. Most of these 106 patients completed treatment in 63 days or less.
The patients’ median household income was $45,782 (range, $19,771–$96,222). The investigators defined “high-income” patients as those whose household incomes were at or above the median, and “low-income” patients as those with incomes below the median.
On average, the patients used 1.24 assistance programs, which included financial assistance (primarily help with clinic visit copays), assistance with medication costs, disability benefits, Medicaid, access to emergency funds, low-cost or free lodging, and transportation.
Dr. Gillen noted that 10% of low-income patients did not use any financial assistance programs.
She and her colleagues found that low-income patients who used assistance programs completed treatment in a similar timeframe as the high-income patients. The median time to treatment completion was 56.5 days and 50 days, respectively.
Registering for disability benefits was significantly associated with improved time to treatment completion (P less than .001).
There were no other significant associations between financial assistance programs and time to treatment completion. However, there was a trend toward improved time to treatment completion among patients who registered for federally funded breast and cervical cancer Medicaid (P = .06).
“[I]t was encouraging to see that enrollment in federally and state-funded programs makes a difference in patients’ ability to complete treatment,” Dr. Gillen said.
She and her colleagues said these data suggest financial assistance programs may help cervical cancer patients overcome barriers to care. Dr. Gillen had no financial disclosures.
SOURCE: Gillen J et al. SGO 2019. Abstract 9.
HONOLULU – Financial assistance programs may help lower-income cervical cancer patients complete treatment in a timely manner, according to research presented at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.
In a retrospective study, lower-income patients who used financial assistance programs were able to complete treatment for cervical cancer in a similar timeframe as higher-income patients.
Lower-income patients who registered for disability benefits saw a significant improvement in time to treatment completion.
Additionally, there was a trend toward improved time to treatment completion among lower-income patients who registered for federally funded breast and cervical cancer treatment.
“Identification of patients who qualify for disability and/or breast/cervical cancer Medicaid, and providing assistance for registration in these programs may help them complete therapy in a more appropriate timeframe,” said study investigator Jessica Gillen, MD, of The University of Oklahoma in Oklahoma City.
Dr. Gillen and her colleagues conducted this single-center, retrospective study of patients with squamous cell, adenocarcinoma, or adenosquamous cancer of the cervix.
The investigators identified 116 evaluable patients who received chemoradiation from January 1, 2015, to July 31, 2018. Most of these 106 patients completed treatment in 63 days or less.
The patients’ median household income was $45,782 (range, $19,771–$96,222). The investigators defined “high-income” patients as those whose household incomes were at or above the median, and “low-income” patients as those with incomes below the median.
On average, the patients used 1.24 assistance programs, which included financial assistance (primarily help with clinic visit copays), assistance with medication costs, disability benefits, Medicaid, access to emergency funds, low-cost or free lodging, and transportation.
Dr. Gillen noted that 10% of low-income patients did not use any financial assistance programs.
She and her colleagues found that low-income patients who used assistance programs completed treatment in a similar timeframe as the high-income patients. The median time to treatment completion was 56.5 days and 50 days, respectively.
Registering for disability benefits was significantly associated with improved time to treatment completion (P less than .001).
There were no other significant associations between financial assistance programs and time to treatment completion. However, there was a trend toward improved time to treatment completion among patients who registered for federally funded breast and cervical cancer Medicaid (P = .06).
“[I]t was encouraging to see that enrollment in federally and state-funded programs makes a difference in patients’ ability to complete treatment,” Dr. Gillen said.
She and her colleagues said these data suggest financial assistance programs may help cervical cancer patients overcome barriers to care. Dr. Gillen had no financial disclosures.
SOURCE: Gillen J et al. SGO 2019. Abstract 9.
HONOLULU – Financial assistance programs may help lower-income cervical cancer patients complete treatment in a timely manner, according to research presented at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.
In a retrospective study, lower-income patients who used financial assistance programs were able to complete treatment for cervical cancer in a similar timeframe as higher-income patients.
Lower-income patients who registered for disability benefits saw a significant improvement in time to treatment completion.
Additionally, there was a trend toward improved time to treatment completion among lower-income patients who registered for federally funded breast and cervical cancer treatment.
“Identification of patients who qualify for disability and/or breast/cervical cancer Medicaid, and providing assistance for registration in these programs may help them complete therapy in a more appropriate timeframe,” said study investigator Jessica Gillen, MD, of The University of Oklahoma in Oklahoma City.
Dr. Gillen and her colleagues conducted this single-center, retrospective study of patients with squamous cell, adenocarcinoma, or adenosquamous cancer of the cervix.
The investigators identified 116 evaluable patients who received chemoradiation from January 1, 2015, to July 31, 2018. Most of these 106 patients completed treatment in 63 days or less.
The patients’ median household income was $45,782 (range, $19,771–$96,222). The investigators defined “high-income” patients as those whose household incomes were at or above the median, and “low-income” patients as those with incomes below the median.
On average, the patients used 1.24 assistance programs, which included financial assistance (primarily help with clinic visit copays), assistance with medication costs, disability benefits, Medicaid, access to emergency funds, low-cost or free lodging, and transportation.
Dr. Gillen noted that 10% of low-income patients did not use any financial assistance programs.
She and her colleagues found that low-income patients who used assistance programs completed treatment in a similar timeframe as the high-income patients. The median time to treatment completion was 56.5 days and 50 days, respectively.
Registering for disability benefits was significantly associated with improved time to treatment completion (P less than .001).
There were no other significant associations between financial assistance programs and time to treatment completion. However, there was a trend toward improved time to treatment completion among patients who registered for federally funded breast and cervical cancer Medicaid (P = .06).
“[I]t was encouraging to see that enrollment in federally and state-funded programs makes a difference in patients’ ability to complete treatment,” Dr. Gillen said.
She and her colleagues said these data suggest financial assistance programs may help cervical cancer patients overcome barriers to care. Dr. Gillen had no financial disclosures.
SOURCE: Gillen J et al. SGO 2019. Abstract 9.
REPORTING FROM SGO 2019
Brachytherapy proves beneficial regardless of treatment duration
, according to a retrospective study.
Researchers found that patients who received brachytherapy in addition to chemotherapy and external beam radiation therapy had better overall survival than patients who received chemoradiation alone.
Although the best overall survival was observed in patients who received brachytherapy within the recommended 8 weeks, patients who received brachytherapy outside that timeframe also had better overall survival than patients treated with chemoradiation alone.
Travis-Riley K. Korenaga, MD, of University of California, San Francisco, presented these findings at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.
To examine the use of brachytherapy, Dr. Korenaga and his colleagues analyzed patients from the U.S. National Cancer Database who had stage II-IVA cervical cancer and were diagnosed between 2004 and 2015.
The researchers identified 18,592 patients who received at least 4,500 cGy of external beam radiation therapy and concurrent chemotherapy as their primary treatment. In this group, there were 17,150 patients who had data on brachytherapy use and time to treatment completion.
A majority of patients (n = 13,642) received brachytherapy, and roughly half of those (n = 6,871) received it within the recommended 8 weeks.
“This is a pretty low rate of adherence to standard of care; 36.9% of women receive brachytherapy and complete it within that 8-week timeframe,” Dr. Korenaga said. “And that 36.9% of women do have a superior overall survival that blows everything else out of the water.”
The median overall survival was:
- 113.7 months (95% confidence interval [CI], 103.3-121.3) in patients who received brachytherapy within 8 weeks
- 75.7 months (95% CI, 69.7-82.4) in those who received brachytherapy for more than 8 weeks
- 58.5 months (95% CI, 48.3-74.2) in patients who received only chemoradiation within 8 weeks
- 46.2 months (95% CI, 39.8-56.4) in those who received only chemoradiation for more than 8 weeks.
“Getting some type of brachytherapy, no matter whether it’s within 8 weeks or beyond 8 weeks, is still associated with an improved overall survival,” Dr. Korenaga noted.
He and his colleagues also identified factors that were significantly associated with a reduced likelihood of receiving brachytherapy within 8 weeks, including:
- Having stage III/IVA disease vs. stage II disease (P less than .0001)
- Being non-Hispanic black vs. non-Hispanic white (P less than .001)
- Having an annual income below $38,000 vs. $63,000 or higher (P less than .0001)
- Having public vs. private insurance (P less than .0001)
- Living 10 to 60 miles (P = .01) or more than 100 miles (P less than .001) from the treatment facility vs. less than 10 miles
- Being treated at a facility with a community cancer program (P = .02) or a comprehensive community cancer program (P less than .0001) vs. an academic research program.
Dr. Korenaga said these results highlight the fact that more work needs to be done to increase the use of brachytherapy in patients with locally advanced cervical cancer.
He and his colleagues have suggested a few measures that might help, including early referrals for brachytherapy, connecting patients with care navigators, and developing centers of excellence for brachytherapy.
Dr. Korenaga had no relevant financial disclosures.
SOURCE: Korenaga TRK et al. SGO 2019. Abstract 10.
, according to a retrospective study.
Researchers found that patients who received brachytherapy in addition to chemotherapy and external beam radiation therapy had better overall survival than patients who received chemoradiation alone.
Although the best overall survival was observed in patients who received brachytherapy within the recommended 8 weeks, patients who received brachytherapy outside that timeframe also had better overall survival than patients treated with chemoradiation alone.
Travis-Riley K. Korenaga, MD, of University of California, San Francisco, presented these findings at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.
To examine the use of brachytherapy, Dr. Korenaga and his colleagues analyzed patients from the U.S. National Cancer Database who had stage II-IVA cervical cancer and were diagnosed between 2004 and 2015.
The researchers identified 18,592 patients who received at least 4,500 cGy of external beam radiation therapy and concurrent chemotherapy as their primary treatment. In this group, there were 17,150 patients who had data on brachytherapy use and time to treatment completion.
A majority of patients (n = 13,642) received brachytherapy, and roughly half of those (n = 6,871) received it within the recommended 8 weeks.
“This is a pretty low rate of adherence to standard of care; 36.9% of women receive brachytherapy and complete it within that 8-week timeframe,” Dr. Korenaga said. “And that 36.9% of women do have a superior overall survival that blows everything else out of the water.”
The median overall survival was:
- 113.7 months (95% confidence interval [CI], 103.3-121.3) in patients who received brachytherapy within 8 weeks
- 75.7 months (95% CI, 69.7-82.4) in those who received brachytherapy for more than 8 weeks
- 58.5 months (95% CI, 48.3-74.2) in patients who received only chemoradiation within 8 weeks
- 46.2 months (95% CI, 39.8-56.4) in those who received only chemoradiation for more than 8 weeks.
“Getting some type of brachytherapy, no matter whether it’s within 8 weeks or beyond 8 weeks, is still associated with an improved overall survival,” Dr. Korenaga noted.
He and his colleagues also identified factors that were significantly associated with a reduced likelihood of receiving brachytherapy within 8 weeks, including:
- Having stage III/IVA disease vs. stage II disease (P less than .0001)
- Being non-Hispanic black vs. non-Hispanic white (P less than .001)
- Having an annual income below $38,000 vs. $63,000 or higher (P less than .0001)
- Having public vs. private insurance (P less than .0001)
- Living 10 to 60 miles (P = .01) or more than 100 miles (P less than .001) from the treatment facility vs. less than 10 miles
- Being treated at a facility with a community cancer program (P = .02) or a comprehensive community cancer program (P less than .0001) vs. an academic research program.
Dr. Korenaga said these results highlight the fact that more work needs to be done to increase the use of brachytherapy in patients with locally advanced cervical cancer.
He and his colleagues have suggested a few measures that might help, including early referrals for brachytherapy, connecting patients with care navigators, and developing centers of excellence for brachytherapy.
Dr. Korenaga had no relevant financial disclosures.
SOURCE: Korenaga TRK et al. SGO 2019. Abstract 10.
, according to a retrospective study.
Researchers found that patients who received brachytherapy in addition to chemotherapy and external beam radiation therapy had better overall survival than patients who received chemoradiation alone.
Although the best overall survival was observed in patients who received brachytherapy within the recommended 8 weeks, patients who received brachytherapy outside that timeframe also had better overall survival than patients treated with chemoradiation alone.
Travis-Riley K. Korenaga, MD, of University of California, San Francisco, presented these findings at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.
To examine the use of brachytherapy, Dr. Korenaga and his colleagues analyzed patients from the U.S. National Cancer Database who had stage II-IVA cervical cancer and were diagnosed between 2004 and 2015.
The researchers identified 18,592 patients who received at least 4,500 cGy of external beam radiation therapy and concurrent chemotherapy as their primary treatment. In this group, there were 17,150 patients who had data on brachytherapy use and time to treatment completion.
A majority of patients (n = 13,642) received brachytherapy, and roughly half of those (n = 6,871) received it within the recommended 8 weeks.
“This is a pretty low rate of adherence to standard of care; 36.9% of women receive brachytherapy and complete it within that 8-week timeframe,” Dr. Korenaga said. “And that 36.9% of women do have a superior overall survival that blows everything else out of the water.”
The median overall survival was:
- 113.7 months (95% confidence interval [CI], 103.3-121.3) in patients who received brachytherapy within 8 weeks
- 75.7 months (95% CI, 69.7-82.4) in those who received brachytherapy for more than 8 weeks
- 58.5 months (95% CI, 48.3-74.2) in patients who received only chemoradiation within 8 weeks
- 46.2 months (95% CI, 39.8-56.4) in those who received only chemoradiation for more than 8 weeks.
“Getting some type of brachytherapy, no matter whether it’s within 8 weeks or beyond 8 weeks, is still associated with an improved overall survival,” Dr. Korenaga noted.
He and his colleagues also identified factors that were significantly associated with a reduced likelihood of receiving brachytherapy within 8 weeks, including:
- Having stage III/IVA disease vs. stage II disease (P less than .0001)
- Being non-Hispanic black vs. non-Hispanic white (P less than .001)
- Having an annual income below $38,000 vs. $63,000 or higher (P less than .0001)
- Having public vs. private insurance (P less than .0001)
- Living 10 to 60 miles (P = .01) or more than 100 miles (P less than .001) from the treatment facility vs. less than 10 miles
- Being treated at a facility with a community cancer program (P = .02) or a comprehensive community cancer program (P less than .0001) vs. an academic research program.
Dr. Korenaga said these results highlight the fact that more work needs to be done to increase the use of brachytherapy in patients with locally advanced cervical cancer.
He and his colleagues have suggested a few measures that might help, including early referrals for brachytherapy, connecting patients with care navigators, and developing centers of excellence for brachytherapy.
Dr. Korenaga had no relevant financial disclosures.
SOURCE: Korenaga TRK et al. SGO 2019. Abstract 10.
REPORTING FROM SGO 2019
CAC score over 1,000 carries higher risks
, based on data from a large retrospective study presented by Allison W. Peng at the annual meeting of the American College of Cardiology.
“Our data argues for consideration of CAC 1000 (or more) as a distinct group with CVD mortality greater than that of contemporary secondary prevention trials ... We showed that those with CAC 1000 (or more) have both a higher area and density of calcification, a more dispersed pattern of calcification in their coronary artery tree (the majority with 4-vessel disease), with a markedly more diffuse distribution of extra-coronary calcification compared to the other CAC groups,” Ms. Peng and her colleagues wrote in the study, which was published online in the Journal of the American College of Cardiology.
Future guidelines should address these patients as a distinct risk group that might gain the most benefit from targeted, aggressive preventive therapy, the researchers said.
Current guidelines identify individuals with CAC scores over 400 as the highest risk group. With a mean follow-up time of 12.3 years, the results from 66,636 asymptomatic individuals in the CAC consortium study, which included over 2,800 patients with CAC (Agatston) scores of 1,000 or more, indicate patients with CAC scores of 1000 or more have nearly a 2-fold higher risk of CVD mortality compared to those with CAC scores of 400-999. While the mortality risk levels off slightly in those with scores exceeding 1000, all-cause and cause-specific mortality risk still increases with no apparent upper CAC threshold.
Patients with a CAC score of at least 1000 were 66.3 years old, on average; 86.3% were male, 52.4% had 4-vessel CAC, and they had a larger total CAC area.
Compared to patients with CAC scores of 400-999, those with a CAC score of 1000 or more had a greater risk of cardiovascular disease (HR, 1.71; 95% CI, 1.41-2.08), coronary heart disease (HR, 1.84; 95% CI, 1.43-2.36), cancer (HR, 1.36; 95% CI, 1.07-1.73), and all-cause mortality (HR, 1.51; 95% CI, 1.33-1.70).
Those with CAC scores of 400-999 had a 2.1, 3.6, 2.7, and 9.8 mortality rate per 1000 person-years for CHD, CVD, cancer, and all-cause mortality, respectively. But those with CAC scores of 1000 of more had a 5.1, 8.0, 4.6, and 18.8 mortality rate per 1000 person-years for CHD, CVD, cancer, and all-cause mortality, respectively.
The leading cause of death was CVD; 36.5% in the CAC 400-999 group and 42.6% in the CAC 1000 or more group. CHD mortality, as a subset of CVD mortality, constituted 21.1% of deaths in the CAC 400-999 group and 27.1% of deaths in the CAC 1000 or more group.
“Future randomized controlled trials of aggressive preventative therapies, for example PCSK9-inhibitors and anti-inflammatory drugs, in patients with CAC ≥ 1000, may prove helpful to evaluate the benefits of such treatment in this unique group,” the authors wrote. They also urged updating current guidelines to reflect best practices for these patients.
The study was funded by The National Institutes of Health. The authors have no relevant financial disclosures.
SOURCE: Peng A et al. Journal of the American College of Cardiology.
, based on data from a large retrospective study presented by Allison W. Peng at the annual meeting of the American College of Cardiology.
“Our data argues for consideration of CAC 1000 (or more) as a distinct group with CVD mortality greater than that of contemporary secondary prevention trials ... We showed that those with CAC 1000 (or more) have both a higher area and density of calcification, a more dispersed pattern of calcification in their coronary artery tree (the majority with 4-vessel disease), with a markedly more diffuse distribution of extra-coronary calcification compared to the other CAC groups,” Ms. Peng and her colleagues wrote in the study, which was published online in the Journal of the American College of Cardiology.
Future guidelines should address these patients as a distinct risk group that might gain the most benefit from targeted, aggressive preventive therapy, the researchers said.
Current guidelines identify individuals with CAC scores over 400 as the highest risk group. With a mean follow-up time of 12.3 years, the results from 66,636 asymptomatic individuals in the CAC consortium study, which included over 2,800 patients with CAC (Agatston) scores of 1,000 or more, indicate patients with CAC scores of 1000 or more have nearly a 2-fold higher risk of CVD mortality compared to those with CAC scores of 400-999. While the mortality risk levels off slightly in those with scores exceeding 1000, all-cause and cause-specific mortality risk still increases with no apparent upper CAC threshold.
Patients with a CAC score of at least 1000 were 66.3 years old, on average; 86.3% were male, 52.4% had 4-vessel CAC, and they had a larger total CAC area.
Compared to patients with CAC scores of 400-999, those with a CAC score of 1000 or more had a greater risk of cardiovascular disease (HR, 1.71; 95% CI, 1.41-2.08), coronary heart disease (HR, 1.84; 95% CI, 1.43-2.36), cancer (HR, 1.36; 95% CI, 1.07-1.73), and all-cause mortality (HR, 1.51; 95% CI, 1.33-1.70).
Those with CAC scores of 400-999 had a 2.1, 3.6, 2.7, and 9.8 mortality rate per 1000 person-years for CHD, CVD, cancer, and all-cause mortality, respectively. But those with CAC scores of 1000 of more had a 5.1, 8.0, 4.6, and 18.8 mortality rate per 1000 person-years for CHD, CVD, cancer, and all-cause mortality, respectively.
The leading cause of death was CVD; 36.5% in the CAC 400-999 group and 42.6% in the CAC 1000 or more group. CHD mortality, as a subset of CVD mortality, constituted 21.1% of deaths in the CAC 400-999 group and 27.1% of deaths in the CAC 1000 or more group.
“Future randomized controlled trials of aggressive preventative therapies, for example PCSK9-inhibitors and anti-inflammatory drugs, in patients with CAC ≥ 1000, may prove helpful to evaluate the benefits of such treatment in this unique group,” the authors wrote. They also urged updating current guidelines to reflect best practices for these patients.
The study was funded by The National Institutes of Health. The authors have no relevant financial disclosures.
SOURCE: Peng A et al. Journal of the American College of Cardiology.
, based on data from a large retrospective study presented by Allison W. Peng at the annual meeting of the American College of Cardiology.
“Our data argues for consideration of CAC 1000 (or more) as a distinct group with CVD mortality greater than that of contemporary secondary prevention trials ... We showed that those with CAC 1000 (or more) have both a higher area and density of calcification, a more dispersed pattern of calcification in their coronary artery tree (the majority with 4-vessel disease), with a markedly more diffuse distribution of extra-coronary calcification compared to the other CAC groups,” Ms. Peng and her colleagues wrote in the study, which was published online in the Journal of the American College of Cardiology.
Future guidelines should address these patients as a distinct risk group that might gain the most benefit from targeted, aggressive preventive therapy, the researchers said.
Current guidelines identify individuals with CAC scores over 400 as the highest risk group. With a mean follow-up time of 12.3 years, the results from 66,636 asymptomatic individuals in the CAC consortium study, which included over 2,800 patients with CAC (Agatston) scores of 1,000 or more, indicate patients with CAC scores of 1000 or more have nearly a 2-fold higher risk of CVD mortality compared to those with CAC scores of 400-999. While the mortality risk levels off slightly in those with scores exceeding 1000, all-cause and cause-specific mortality risk still increases with no apparent upper CAC threshold.
Patients with a CAC score of at least 1000 were 66.3 years old, on average; 86.3% were male, 52.4% had 4-vessel CAC, and they had a larger total CAC area.
Compared to patients with CAC scores of 400-999, those with a CAC score of 1000 or more had a greater risk of cardiovascular disease (HR, 1.71; 95% CI, 1.41-2.08), coronary heart disease (HR, 1.84; 95% CI, 1.43-2.36), cancer (HR, 1.36; 95% CI, 1.07-1.73), and all-cause mortality (HR, 1.51; 95% CI, 1.33-1.70).
Those with CAC scores of 400-999 had a 2.1, 3.6, 2.7, and 9.8 mortality rate per 1000 person-years for CHD, CVD, cancer, and all-cause mortality, respectively. But those with CAC scores of 1000 of more had a 5.1, 8.0, 4.6, and 18.8 mortality rate per 1000 person-years for CHD, CVD, cancer, and all-cause mortality, respectively.
The leading cause of death was CVD; 36.5% in the CAC 400-999 group and 42.6% in the CAC 1000 or more group. CHD mortality, as a subset of CVD mortality, constituted 21.1% of deaths in the CAC 400-999 group and 27.1% of deaths in the CAC 1000 or more group.
“Future randomized controlled trials of aggressive preventative therapies, for example PCSK9-inhibitors and anti-inflammatory drugs, in patients with CAC ≥ 1000, may prove helpful to evaluate the benefits of such treatment in this unique group,” the authors wrote. They also urged updating current guidelines to reflect best practices for these patients.
The study was funded by The National Institutes of Health. The authors have no relevant financial disclosures.
SOURCE: Peng A et al. Journal of the American College of Cardiology.
FROM ACC 2019