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‘Stunning variation’ in CV test, procedure costs revealed at top U.S. hospitals
Wide variation in the cost of common cardiovascular (CV) tests and procedures, from stress tests to coronary interventions, was revealed in a cross-sectional analysis based on publicly available data from 20 top-ranked hospitals in the United States.
The analysis also suggested a low level of compliance with the 2021 Hospital Price Transparency Final Rule among the 20 centers.
“The variation we found in payer-negotiated prices for identical cardiovascular tests and procedures was stunning,” Rishi K. Wadhera, MD, MPP, MPhil, Beth Israel Deaconess Medical Center, Boston, told this news organization.
“For example, there was a 10-fold difference in the median price of an echocardiogram, and these differences were even larger for common procedures” such as percutaneous coronary intervention (PCI) and pacemaker implantation, he said. “It’s hard to argue that this variation reflects quality of care, given that we looked at a top group of highly ranked hospitals.”
“Even more striking was how the price of a cardiovascular test within the very same hospital could differ across commercial insurance companies,” he said. “For example, the price of a stress test varied 5-fold in one hospital, and in another hospital, more than 4-fold for a coronary angiogram.”
Dr. Wadhera is senior author on the study published online as a research letter in JAMA Internal Medicine, with lead author Andrew S. Oseran, MD, MBA, also from Beth Israel Deaconess Medical Center.
Difficulties with data, interpretation
The researchers looked at payer and self-pay cash prices for noninvasive and invasive CV tests and procedures at the U.S. News & World Report 2021 top 20–ranked U.S. hospitals, based in part on Current Procedural Terminology codes.
Price differences among the hospitals were derived from median negotiated prices for each test and procedure at the centers across all payers. The interquartile ratio (IQR) of prices for each test or procedure across payers was used to evaluate within-hospital price variation.
“Only 80% of the hospitals reported prices for some cardiovascular tests and procedures,” Dr. Wadhera said. “For the most part, even among the hospitals that did report this information, it was extremely challenging to navigate and interpret the data provided.”
Further, the team found that only 7 of the 20 hospitals reported prices for all CV tests and procedures. Centers that did not post prices for some tests or procedures are named in the report’s Figure 1 and Figure 2.
The number of insurance plans listed for each test or procedure ranged from 1 to 432 in the analysis. Median prices ranged from $204 to $2,588 for an echocardiogram, $463 to $3,230 for a stress test, $2,821 to $9,382 for right heart catheterization, $2,868 to $9,203 for a coronary angiogram, $657 to $25,521 for a PCI, and $506 to $20,002 for pacemaker implantation, the report states.
A similar pattern was seen for self-pay cash prices.
Within-hospital variation also ranged broadly. For example, the widest IQR ranges were $3,143-$12,926 for a right heart catheterization, $4,011-$14,486 for a coronary angiogram, $11,325-$23,392 for a PCI, and $8,474-$22,694 for pacemaker implantation.
The report cites a number of limitations to the analysis, among those, the need to rely on the hospitals themselves for data quality and accuracy.
‘More needed besides transparency’
“As a means to better understand health care costs, many opined that full price transparency would leverage market dynamics and result in lower costs,” observed Clyde W. Yancy, MD, MSc, professor of medicine and chief of cardiology at Northwestern Medicine, Chicago. The findings “by an expert group of outcomes scientists make clear that more is needed besides price transparency to lower cost,” he said in an interview.
That said, he added, “there are sufficient variations and allowances made for data collection that it is preferable to hold the current findings circumspect at best. Importantly, the voice of the hospitals does not appear.”
Although “price variation among the top 20 hospitals is substantial,” he observed, “without a better assessment of root cause, actual charge capture, prevailing market dynamics – especially nursing and ancillary staff costs – and the general influence of inflation, it is too difficult to emerge with a precise interpretation.”
Across the 20 hospitals, “there are likely to be 20 different business models,” he added, with negotiated prices reflecting “at least regional, if not institutional, variations.”
“These are complex issues. The several-fold price differences in standard procedures are a concern and an area worth further study with the intention of lowering health care costs,” Dr. Yancy said. “But clearly our next efforts should not address lowering prices per se but understanding how prices are set [and] the connection with reimbursement and actual payments.”
Dr. Wadhera discloses receiving personal fees from Abbott and CVS Health unrelated to the current study; disclosures for the other authors are in the report. Dr. Yancy is deputy editor of JAMA Cardiology.
A version of this article first appeared on Medscape.com.
Wide variation in the cost of common cardiovascular (CV) tests and procedures, from stress tests to coronary interventions, was revealed in a cross-sectional analysis based on publicly available data from 20 top-ranked hospitals in the United States.
The analysis also suggested a low level of compliance with the 2021 Hospital Price Transparency Final Rule among the 20 centers.
“The variation we found in payer-negotiated prices for identical cardiovascular tests and procedures was stunning,” Rishi K. Wadhera, MD, MPP, MPhil, Beth Israel Deaconess Medical Center, Boston, told this news organization.
“For example, there was a 10-fold difference in the median price of an echocardiogram, and these differences were even larger for common procedures” such as percutaneous coronary intervention (PCI) and pacemaker implantation, he said. “It’s hard to argue that this variation reflects quality of care, given that we looked at a top group of highly ranked hospitals.”
“Even more striking was how the price of a cardiovascular test within the very same hospital could differ across commercial insurance companies,” he said. “For example, the price of a stress test varied 5-fold in one hospital, and in another hospital, more than 4-fold for a coronary angiogram.”
Dr. Wadhera is senior author on the study published online as a research letter in JAMA Internal Medicine, with lead author Andrew S. Oseran, MD, MBA, also from Beth Israel Deaconess Medical Center.
Difficulties with data, interpretation
The researchers looked at payer and self-pay cash prices for noninvasive and invasive CV tests and procedures at the U.S. News & World Report 2021 top 20–ranked U.S. hospitals, based in part on Current Procedural Terminology codes.
Price differences among the hospitals were derived from median negotiated prices for each test and procedure at the centers across all payers. The interquartile ratio (IQR) of prices for each test or procedure across payers was used to evaluate within-hospital price variation.
“Only 80% of the hospitals reported prices for some cardiovascular tests and procedures,” Dr. Wadhera said. “For the most part, even among the hospitals that did report this information, it was extremely challenging to navigate and interpret the data provided.”
Further, the team found that only 7 of the 20 hospitals reported prices for all CV tests and procedures. Centers that did not post prices for some tests or procedures are named in the report’s Figure 1 and Figure 2.
The number of insurance plans listed for each test or procedure ranged from 1 to 432 in the analysis. Median prices ranged from $204 to $2,588 for an echocardiogram, $463 to $3,230 for a stress test, $2,821 to $9,382 for right heart catheterization, $2,868 to $9,203 for a coronary angiogram, $657 to $25,521 for a PCI, and $506 to $20,002 for pacemaker implantation, the report states.
A similar pattern was seen for self-pay cash prices.
Within-hospital variation also ranged broadly. For example, the widest IQR ranges were $3,143-$12,926 for a right heart catheterization, $4,011-$14,486 for a coronary angiogram, $11,325-$23,392 for a PCI, and $8,474-$22,694 for pacemaker implantation.
The report cites a number of limitations to the analysis, among those, the need to rely on the hospitals themselves for data quality and accuracy.
‘More needed besides transparency’
“As a means to better understand health care costs, many opined that full price transparency would leverage market dynamics and result in lower costs,” observed Clyde W. Yancy, MD, MSc, professor of medicine and chief of cardiology at Northwestern Medicine, Chicago. The findings “by an expert group of outcomes scientists make clear that more is needed besides price transparency to lower cost,” he said in an interview.
That said, he added, “there are sufficient variations and allowances made for data collection that it is preferable to hold the current findings circumspect at best. Importantly, the voice of the hospitals does not appear.”
Although “price variation among the top 20 hospitals is substantial,” he observed, “without a better assessment of root cause, actual charge capture, prevailing market dynamics – especially nursing and ancillary staff costs – and the general influence of inflation, it is too difficult to emerge with a precise interpretation.”
Across the 20 hospitals, “there are likely to be 20 different business models,” he added, with negotiated prices reflecting “at least regional, if not institutional, variations.”
“These are complex issues. The several-fold price differences in standard procedures are a concern and an area worth further study with the intention of lowering health care costs,” Dr. Yancy said. “But clearly our next efforts should not address lowering prices per se but understanding how prices are set [and] the connection with reimbursement and actual payments.”
Dr. Wadhera discloses receiving personal fees from Abbott and CVS Health unrelated to the current study; disclosures for the other authors are in the report. Dr. Yancy is deputy editor of JAMA Cardiology.
A version of this article first appeared on Medscape.com.
Wide variation in the cost of common cardiovascular (CV) tests and procedures, from stress tests to coronary interventions, was revealed in a cross-sectional analysis based on publicly available data from 20 top-ranked hospitals in the United States.
The analysis also suggested a low level of compliance with the 2021 Hospital Price Transparency Final Rule among the 20 centers.
“The variation we found in payer-negotiated prices for identical cardiovascular tests and procedures was stunning,” Rishi K. Wadhera, MD, MPP, MPhil, Beth Israel Deaconess Medical Center, Boston, told this news organization.
“For example, there was a 10-fold difference in the median price of an echocardiogram, and these differences were even larger for common procedures” such as percutaneous coronary intervention (PCI) and pacemaker implantation, he said. “It’s hard to argue that this variation reflects quality of care, given that we looked at a top group of highly ranked hospitals.”
“Even more striking was how the price of a cardiovascular test within the very same hospital could differ across commercial insurance companies,” he said. “For example, the price of a stress test varied 5-fold in one hospital, and in another hospital, more than 4-fold for a coronary angiogram.”
Dr. Wadhera is senior author on the study published online as a research letter in JAMA Internal Medicine, with lead author Andrew S. Oseran, MD, MBA, also from Beth Israel Deaconess Medical Center.
Difficulties with data, interpretation
The researchers looked at payer and self-pay cash prices for noninvasive and invasive CV tests and procedures at the U.S. News & World Report 2021 top 20–ranked U.S. hospitals, based in part on Current Procedural Terminology codes.
Price differences among the hospitals were derived from median negotiated prices for each test and procedure at the centers across all payers. The interquartile ratio (IQR) of prices for each test or procedure across payers was used to evaluate within-hospital price variation.
“Only 80% of the hospitals reported prices for some cardiovascular tests and procedures,” Dr. Wadhera said. “For the most part, even among the hospitals that did report this information, it was extremely challenging to navigate and interpret the data provided.”
Further, the team found that only 7 of the 20 hospitals reported prices for all CV tests and procedures. Centers that did not post prices for some tests or procedures are named in the report’s Figure 1 and Figure 2.
The number of insurance plans listed for each test or procedure ranged from 1 to 432 in the analysis. Median prices ranged from $204 to $2,588 for an echocardiogram, $463 to $3,230 for a stress test, $2,821 to $9,382 for right heart catheterization, $2,868 to $9,203 for a coronary angiogram, $657 to $25,521 for a PCI, and $506 to $20,002 for pacemaker implantation, the report states.
A similar pattern was seen for self-pay cash prices.
Within-hospital variation also ranged broadly. For example, the widest IQR ranges were $3,143-$12,926 for a right heart catheterization, $4,011-$14,486 for a coronary angiogram, $11,325-$23,392 for a PCI, and $8,474-$22,694 for pacemaker implantation.
The report cites a number of limitations to the analysis, among those, the need to rely on the hospitals themselves for data quality and accuracy.
‘More needed besides transparency’
“As a means to better understand health care costs, many opined that full price transparency would leverage market dynamics and result in lower costs,” observed Clyde W. Yancy, MD, MSc, professor of medicine and chief of cardiology at Northwestern Medicine, Chicago. The findings “by an expert group of outcomes scientists make clear that more is needed besides price transparency to lower cost,” he said in an interview.
That said, he added, “there are sufficient variations and allowances made for data collection that it is preferable to hold the current findings circumspect at best. Importantly, the voice of the hospitals does not appear.”
Although “price variation among the top 20 hospitals is substantial,” he observed, “without a better assessment of root cause, actual charge capture, prevailing market dynamics – especially nursing and ancillary staff costs – and the general influence of inflation, it is too difficult to emerge with a precise interpretation.”
Across the 20 hospitals, “there are likely to be 20 different business models,” he added, with negotiated prices reflecting “at least regional, if not institutional, variations.”
“These are complex issues. The several-fold price differences in standard procedures are a concern and an area worth further study with the intention of lowering health care costs,” Dr. Yancy said. “But clearly our next efforts should not address lowering prices per se but understanding how prices are set [and] the connection with reimbursement and actual payments.”
Dr. Wadhera discloses receiving personal fees from Abbott and CVS Health unrelated to the current study; disclosures for the other authors are in the report. Dr. Yancy is deputy editor of JAMA Cardiology.
A version of this article first appeared on Medscape.com.
Early cardiac rehab as effective as later start after sternotomy
Cardiac rehabilitation (CR) started 2 weeks after sternotomy for a cardiac procedure was noninferior to usual care, in which CR starts 6 weeks after the procedure, with a greater improvement in 6-minute walk test outcomes, a randomized study suggests.
There was no difference in adverse events between groups, although the researchers pointed out that the study was not powered specifically for safety outcomes.
“Cardiac surgical techniques have evolved significantly over the last 60 years, leading to improved survival and shorter hospital stays,” Gordon McGregor, PhD, University of Warwick, Coventry, England, told this news organization. “However, sternal precautions and rehabilitation guidelines have not changed accordingly. There has never been a guideline based on empirical evidence to support rehabilitation professionals working with cardiac surgery patients after median sternotomy.”
“By adopting a progressive individualized approach,” he added, “cardiac surgery sternotomy patients can start cardiac rehabilitation up to 4 weeks earlier than current guidance, and thus potentially complete their recovery sooner.”
Results of the Early Initiation of Poststernotomy Cardiac Rehabilitation Exercise Training study were published online in JAMA Cardiology.
In the study, Dr. McGregor and colleagues randomly assigned 158 patients (mean age, 63 years; 84% men) to 8 weeks of 1-hour, twice-weekly supervised CR exercise training starting 2 weeks (early) or 6 weeks (usual care) after sternotomy.
The primary outcome was change in the 6-minute walk test distance from baseline to 10 or 14 weeks after sternotomy, respectively, and 12 months after randomization.
For usual care, training followed British standards: a warm-up with light cardiovascular and mobility exercises; continuous moderate-intensity cardiovascular exercise; a cooldown; functional exercises using resistance machines and free weights; and upper-body exercises designed to prevent sternal and leg wound pain and complications.
There are no specific outpatient CR exercise guidelines for early CR, so study participants followed an individualized exercise program for the first 2-3 weeks after surgery, starting with light mobility and moderate-intensity cardiovascular training when they could do those exercises with minimal discomfort. They then progressed to current British standards, as per usual care.
Forty patients were lost to follow-up, largely because of the pandemic; about half the participants in each group were included in the primary analysis.
Early CR was not inferior to usual care, the authors wrote. The mean change in 6-minute walk distance from baseline to completion of CR was 28 meters greater in the early group than in the usual-care group, and was achieved 4 weeks earlier in the recovery timeline.
Secondary outcomes (functional fitness and quality of life) improved in both groups and between-group differences were not statistically significant, indicating the noninferiority of early CR, the authors noted.
Safety not proven
There were more adverse events in the early group than in the usual-care group (58 vs. 46) and more serious adverse events (18 vs. 14), but fewer deaths (1 vs. 2).
Although there was no between-group difference in the likelihood of having an adverse or serious adverse event, Dr. McGregor acknowledged that the study was “not powered specifically for safety outcomes.” He added that “there is the potential to run a very large multination definitive superiority [randomized, controlled trial] with safety as the primary outcome; however, a very large sample would be required.”
Meanwhile, he said, “we can say with some degree of certainty that early CR was likely as safe as usual-care CR. In the United Kingdom, we work closely with the British Association for Cardiovascular Prevention and Rehabilitation and the Association of Chartered Physiotherapists in Cardiovascular Rehabilitation, who will incorporate our findings in their guidelines and training courses.”
Questions remain
Asked to comment on the study, John Larry, MD, medical director of cardiology and cardiac rehabilitation at the Ohio State University Wexner Medical Center East Hospital, Columbus, said: “For those under time pressure to return to work, [early CR] could be an advantage to allow more rehab time and improved stamina prior to their return-to-work date.”
That said, he noted, “we typically delay any significant upper-body training activities for 8-10 weeks to avoid impact on healing of the sternum. Thus ... starting sooner would limit the amount of time a patient would have to engage in any upper-body resistance training. Many lose upper body strength after surgery, so this is an important part of the recovery/rehab process.”
Matthew Tomey, MD, director of the cardiac intensive care unit, Mount Sinai Morningside, New York, advised “caution” when interpreting the findings, stating that “there was no evident difference in the primary outcome measure of functional capacity by 14 weeks, and the trial was not designed to directly assess impact on either social functioning or economic productivity.”
“I would be interested to [see] more comprehensive data on safety in a larger, more diverse sample of postoperative patients,” he said, “as well as evidence to indicate clear advantage of an earlier start for patient-centered outcomes specifically after cardiac surgery.
“Perhaps the greatest challenges to full realization of the benefits of CR in practice have been gaps in referral and gaps in enrollment,” he added. “It is incumbent upon us as clinicians to counsel our patients and to provide appropriate referrals.”
The study was supported by the Medical and Life Sciences Research Fund and the Jeremy Pilcher Memorial Fund. No conflicts of interest were reported.
A version of this article first appeared on Medscape.com.
Cardiac rehabilitation (CR) started 2 weeks after sternotomy for a cardiac procedure was noninferior to usual care, in which CR starts 6 weeks after the procedure, with a greater improvement in 6-minute walk test outcomes, a randomized study suggests.
There was no difference in adverse events between groups, although the researchers pointed out that the study was not powered specifically for safety outcomes.
“Cardiac surgical techniques have evolved significantly over the last 60 years, leading to improved survival and shorter hospital stays,” Gordon McGregor, PhD, University of Warwick, Coventry, England, told this news organization. “However, sternal precautions and rehabilitation guidelines have not changed accordingly. There has never been a guideline based on empirical evidence to support rehabilitation professionals working with cardiac surgery patients after median sternotomy.”
“By adopting a progressive individualized approach,” he added, “cardiac surgery sternotomy patients can start cardiac rehabilitation up to 4 weeks earlier than current guidance, and thus potentially complete their recovery sooner.”
Results of the Early Initiation of Poststernotomy Cardiac Rehabilitation Exercise Training study were published online in JAMA Cardiology.
In the study, Dr. McGregor and colleagues randomly assigned 158 patients (mean age, 63 years; 84% men) to 8 weeks of 1-hour, twice-weekly supervised CR exercise training starting 2 weeks (early) or 6 weeks (usual care) after sternotomy.
The primary outcome was change in the 6-minute walk test distance from baseline to 10 or 14 weeks after sternotomy, respectively, and 12 months after randomization.
For usual care, training followed British standards: a warm-up with light cardiovascular and mobility exercises; continuous moderate-intensity cardiovascular exercise; a cooldown; functional exercises using resistance machines and free weights; and upper-body exercises designed to prevent sternal and leg wound pain and complications.
There are no specific outpatient CR exercise guidelines for early CR, so study participants followed an individualized exercise program for the first 2-3 weeks after surgery, starting with light mobility and moderate-intensity cardiovascular training when they could do those exercises with minimal discomfort. They then progressed to current British standards, as per usual care.
Forty patients were lost to follow-up, largely because of the pandemic; about half the participants in each group were included in the primary analysis.
Early CR was not inferior to usual care, the authors wrote. The mean change in 6-minute walk distance from baseline to completion of CR was 28 meters greater in the early group than in the usual-care group, and was achieved 4 weeks earlier in the recovery timeline.
Secondary outcomes (functional fitness and quality of life) improved in both groups and between-group differences were not statistically significant, indicating the noninferiority of early CR, the authors noted.
Safety not proven
There were more adverse events in the early group than in the usual-care group (58 vs. 46) and more serious adverse events (18 vs. 14), but fewer deaths (1 vs. 2).
Although there was no between-group difference in the likelihood of having an adverse or serious adverse event, Dr. McGregor acknowledged that the study was “not powered specifically for safety outcomes.” He added that “there is the potential to run a very large multination definitive superiority [randomized, controlled trial] with safety as the primary outcome; however, a very large sample would be required.”
Meanwhile, he said, “we can say with some degree of certainty that early CR was likely as safe as usual-care CR. In the United Kingdom, we work closely with the British Association for Cardiovascular Prevention and Rehabilitation and the Association of Chartered Physiotherapists in Cardiovascular Rehabilitation, who will incorporate our findings in their guidelines and training courses.”
Questions remain
Asked to comment on the study, John Larry, MD, medical director of cardiology and cardiac rehabilitation at the Ohio State University Wexner Medical Center East Hospital, Columbus, said: “For those under time pressure to return to work, [early CR] could be an advantage to allow more rehab time and improved stamina prior to their return-to-work date.”
That said, he noted, “we typically delay any significant upper-body training activities for 8-10 weeks to avoid impact on healing of the sternum. Thus ... starting sooner would limit the amount of time a patient would have to engage in any upper-body resistance training. Many lose upper body strength after surgery, so this is an important part of the recovery/rehab process.”
Matthew Tomey, MD, director of the cardiac intensive care unit, Mount Sinai Morningside, New York, advised “caution” when interpreting the findings, stating that “there was no evident difference in the primary outcome measure of functional capacity by 14 weeks, and the trial was not designed to directly assess impact on either social functioning or economic productivity.”
“I would be interested to [see] more comprehensive data on safety in a larger, more diverse sample of postoperative patients,” he said, “as well as evidence to indicate clear advantage of an earlier start for patient-centered outcomes specifically after cardiac surgery.
“Perhaps the greatest challenges to full realization of the benefits of CR in practice have been gaps in referral and gaps in enrollment,” he added. “It is incumbent upon us as clinicians to counsel our patients and to provide appropriate referrals.”
The study was supported by the Medical and Life Sciences Research Fund and the Jeremy Pilcher Memorial Fund. No conflicts of interest were reported.
A version of this article first appeared on Medscape.com.
Cardiac rehabilitation (CR) started 2 weeks after sternotomy for a cardiac procedure was noninferior to usual care, in which CR starts 6 weeks after the procedure, with a greater improvement in 6-minute walk test outcomes, a randomized study suggests.
There was no difference in adverse events between groups, although the researchers pointed out that the study was not powered specifically for safety outcomes.
“Cardiac surgical techniques have evolved significantly over the last 60 years, leading to improved survival and shorter hospital stays,” Gordon McGregor, PhD, University of Warwick, Coventry, England, told this news organization. “However, sternal precautions and rehabilitation guidelines have not changed accordingly. There has never been a guideline based on empirical evidence to support rehabilitation professionals working with cardiac surgery patients after median sternotomy.”
“By adopting a progressive individualized approach,” he added, “cardiac surgery sternotomy patients can start cardiac rehabilitation up to 4 weeks earlier than current guidance, and thus potentially complete their recovery sooner.”
Results of the Early Initiation of Poststernotomy Cardiac Rehabilitation Exercise Training study were published online in JAMA Cardiology.
In the study, Dr. McGregor and colleagues randomly assigned 158 patients (mean age, 63 years; 84% men) to 8 weeks of 1-hour, twice-weekly supervised CR exercise training starting 2 weeks (early) or 6 weeks (usual care) after sternotomy.
The primary outcome was change in the 6-minute walk test distance from baseline to 10 or 14 weeks after sternotomy, respectively, and 12 months after randomization.
For usual care, training followed British standards: a warm-up with light cardiovascular and mobility exercises; continuous moderate-intensity cardiovascular exercise; a cooldown; functional exercises using resistance machines and free weights; and upper-body exercises designed to prevent sternal and leg wound pain and complications.
There are no specific outpatient CR exercise guidelines for early CR, so study participants followed an individualized exercise program for the first 2-3 weeks after surgery, starting with light mobility and moderate-intensity cardiovascular training when they could do those exercises with minimal discomfort. They then progressed to current British standards, as per usual care.
Forty patients were lost to follow-up, largely because of the pandemic; about half the participants in each group were included in the primary analysis.
Early CR was not inferior to usual care, the authors wrote. The mean change in 6-minute walk distance from baseline to completion of CR was 28 meters greater in the early group than in the usual-care group, and was achieved 4 weeks earlier in the recovery timeline.
Secondary outcomes (functional fitness and quality of life) improved in both groups and between-group differences were not statistically significant, indicating the noninferiority of early CR, the authors noted.
Safety not proven
There were more adverse events in the early group than in the usual-care group (58 vs. 46) and more serious adverse events (18 vs. 14), but fewer deaths (1 vs. 2).
Although there was no between-group difference in the likelihood of having an adverse or serious adverse event, Dr. McGregor acknowledged that the study was “not powered specifically for safety outcomes.” He added that “there is the potential to run a very large multination definitive superiority [randomized, controlled trial] with safety as the primary outcome; however, a very large sample would be required.”
Meanwhile, he said, “we can say with some degree of certainty that early CR was likely as safe as usual-care CR. In the United Kingdom, we work closely with the British Association for Cardiovascular Prevention and Rehabilitation and the Association of Chartered Physiotherapists in Cardiovascular Rehabilitation, who will incorporate our findings in their guidelines and training courses.”
Questions remain
Asked to comment on the study, John Larry, MD, medical director of cardiology and cardiac rehabilitation at the Ohio State University Wexner Medical Center East Hospital, Columbus, said: “For those under time pressure to return to work, [early CR] could be an advantage to allow more rehab time and improved stamina prior to their return-to-work date.”
That said, he noted, “we typically delay any significant upper-body training activities for 8-10 weeks to avoid impact on healing of the sternum. Thus ... starting sooner would limit the amount of time a patient would have to engage in any upper-body resistance training. Many lose upper body strength after surgery, so this is an important part of the recovery/rehab process.”
Matthew Tomey, MD, director of the cardiac intensive care unit, Mount Sinai Morningside, New York, advised “caution” when interpreting the findings, stating that “there was no evident difference in the primary outcome measure of functional capacity by 14 weeks, and the trial was not designed to directly assess impact on either social functioning or economic productivity.”
“I would be interested to [see] more comprehensive data on safety in a larger, more diverse sample of postoperative patients,” he said, “as well as evidence to indicate clear advantage of an earlier start for patient-centered outcomes specifically after cardiac surgery.
“Perhaps the greatest challenges to full realization of the benefits of CR in practice have been gaps in referral and gaps in enrollment,” he added. “It is incumbent upon us as clinicians to counsel our patients and to provide appropriate referrals.”
The study was supported by the Medical and Life Sciences Research Fund and the Jeremy Pilcher Memorial Fund. No conflicts of interest were reported.
A version of this article first appeared on Medscape.com.
FROM JAMA CARDIOLOGY
New saliva-based COVID-19 test provides rapid results
A rapid, saliva-based test for COVID-19 could enable testing, diagnosis, and prescribing to take place in a single office visit by immediately confirming whether a patient has the infection and needs to be treated, researchers say. The test has sparked commercial interest and earned additional funding from the Canadian government.
The test uses a DNA aptamer – a short, synthetic oligonucleotide that binds to a specific molecular target – that shows high affinity for the SARS-CoV-2 spike protein and its variants. The approach “can be rapidly adapted to different threats,” as well, Leyla Soleymani, PhD, an associate professor of engineering physics at McMaster University, Hamilton, Ontario, Canada, told this news organization. Her team invented the approach.
Adaptable to other pathogens
Current gold-standard COVID-19 tests are based on reverse transcription-polymerase chain reaction (RT-PCR), which are sensitive but costly, complicated, and require waiting at least a couple of days for results, according to Dr. Soleymani and colleagues. Rapid nucleic acid and antigen tests have only “moderate” sensitivity and specificity, particularly when viral loads are low. None have been shown to work well with saliva samples.
By contrast, the new test “uses a reader and test cartridges, similar to the glucose reader,” said Dr. Soleymani, who is also Canada Research chair in Miniaturized Biomedical Devices. A small sample of saliva is added to a chemical reagent and inserted into the reader, which is attached to a smartphone. Once commercialized, the point-of-care test is expected to be performed quickly in a physician’s office or in a clinic.
“The same reader can be applied to a variety of infectious diseases or infection panels by developing new cartridges,” Dr. Soleymani explained. “Noroviruses and bacteria such as C. difficile are on our list” to examine next.What’s more, she added, “this test is ideally positioned for settings where access to centralized labs is not possible, such as less developed countries.”
The team’s recent studies seem to support the promise. A study published last year in the international edition of Angewandte Chemie documents the development of the test, which at that point could detect wild-type SARS-CoV-2 and its Alpha and Delta variants in unprocessed saliva samples in 10 minutes with 80.5% sensitivity and 100% specificity.
This study was followed in January 2022 by a paper in Chemistry showing that the device also detected Alpha, Gamma, Epsilon, Kappa, and Omicron variants, demonstrating its potential for recognizing rapidly evolving targets such as those found in SARS-CoV-2.
In another demonstration of its versatility, the technology was recently adapted and successfully detected animal viruses from saliva samples.
Commercial and government funding
The findings prompted Zentek, an intellectual property development and commercialization company in Guelph, Ont., to license the technology, with plans to invest more than $1 million in the next 5 years to scale up production of the test components and adapt the technology for other forms of infection.
Furthermore, the collaborative efforts required to develop the test and move it forward gained funding from Canada’s Natural Sciences and Engineering Research Council, which is investing nearly $1.5 million in the form of two grants: $1 million to further streamline the technology development in preparation for the next pandemic and $488,440 (including $140,000 from Zentek) to get the current test to market as quickly as possible.
Meanwhile, Dr. Soleymani is urging clinicians “to be open to nontraditional diagnostic approaches even if the traditional tests do the job. Such tests are more rapid and can be used to enable personalized medicine. Our success relies on collaboration and support from clinicians.”
Further validation needed
Daniel Kuritzkes, MD, chief of infectious diseases at Brigham and Women’s Hospital and the Harriet Ryan Albee Professor of Medicine at Harvard Medical School, Boston, commented on the study in response to a request from this news organization.
While “it’s always good to have more testing options available,” he said, “we don’t yet have very much information about performance characteristics of the test – that is, its sensitivity and specificity. I’d like to see the performance characteristics of this test compared to PCR tests and to the current rapid antigen tests using a large number of patient samples with currently circulating variants, and tests over time to see how soon tests become positive after symptom onset and for how long they remain positive.”
“Further validation studies and emergency use authorization or approval by regulatory authorities are needed before we will see this test implemented in the field,” Dr. Kuritzkes concluded.
A version of this article first appeared on Medscape.com.
A rapid, saliva-based test for COVID-19 could enable testing, diagnosis, and prescribing to take place in a single office visit by immediately confirming whether a patient has the infection and needs to be treated, researchers say. The test has sparked commercial interest and earned additional funding from the Canadian government.
The test uses a DNA aptamer – a short, synthetic oligonucleotide that binds to a specific molecular target – that shows high affinity for the SARS-CoV-2 spike protein and its variants. The approach “can be rapidly adapted to different threats,” as well, Leyla Soleymani, PhD, an associate professor of engineering physics at McMaster University, Hamilton, Ontario, Canada, told this news organization. Her team invented the approach.
Adaptable to other pathogens
Current gold-standard COVID-19 tests are based on reverse transcription-polymerase chain reaction (RT-PCR), which are sensitive but costly, complicated, and require waiting at least a couple of days for results, according to Dr. Soleymani and colleagues. Rapid nucleic acid and antigen tests have only “moderate” sensitivity and specificity, particularly when viral loads are low. None have been shown to work well with saliva samples.
By contrast, the new test “uses a reader and test cartridges, similar to the glucose reader,” said Dr. Soleymani, who is also Canada Research chair in Miniaturized Biomedical Devices. A small sample of saliva is added to a chemical reagent and inserted into the reader, which is attached to a smartphone. Once commercialized, the point-of-care test is expected to be performed quickly in a physician’s office or in a clinic.
“The same reader can be applied to a variety of infectious diseases or infection panels by developing new cartridges,” Dr. Soleymani explained. “Noroviruses and bacteria such as C. difficile are on our list” to examine next.What’s more, she added, “this test is ideally positioned for settings where access to centralized labs is not possible, such as less developed countries.”
The team’s recent studies seem to support the promise. A study published last year in the international edition of Angewandte Chemie documents the development of the test, which at that point could detect wild-type SARS-CoV-2 and its Alpha and Delta variants in unprocessed saliva samples in 10 minutes with 80.5% sensitivity and 100% specificity.
This study was followed in January 2022 by a paper in Chemistry showing that the device also detected Alpha, Gamma, Epsilon, Kappa, and Omicron variants, demonstrating its potential for recognizing rapidly evolving targets such as those found in SARS-CoV-2.
In another demonstration of its versatility, the technology was recently adapted and successfully detected animal viruses from saliva samples.
Commercial and government funding
The findings prompted Zentek, an intellectual property development and commercialization company in Guelph, Ont., to license the technology, with plans to invest more than $1 million in the next 5 years to scale up production of the test components and adapt the technology for other forms of infection.
Furthermore, the collaborative efforts required to develop the test and move it forward gained funding from Canada’s Natural Sciences and Engineering Research Council, which is investing nearly $1.5 million in the form of two grants: $1 million to further streamline the technology development in preparation for the next pandemic and $488,440 (including $140,000 from Zentek) to get the current test to market as quickly as possible.
Meanwhile, Dr. Soleymani is urging clinicians “to be open to nontraditional diagnostic approaches even if the traditional tests do the job. Such tests are more rapid and can be used to enable personalized medicine. Our success relies on collaboration and support from clinicians.”
Further validation needed
Daniel Kuritzkes, MD, chief of infectious diseases at Brigham and Women’s Hospital and the Harriet Ryan Albee Professor of Medicine at Harvard Medical School, Boston, commented on the study in response to a request from this news organization.
While “it’s always good to have more testing options available,” he said, “we don’t yet have very much information about performance characteristics of the test – that is, its sensitivity and specificity. I’d like to see the performance characteristics of this test compared to PCR tests and to the current rapid antigen tests using a large number of patient samples with currently circulating variants, and tests over time to see how soon tests become positive after symptom onset and for how long they remain positive.”
“Further validation studies and emergency use authorization or approval by regulatory authorities are needed before we will see this test implemented in the field,” Dr. Kuritzkes concluded.
A version of this article first appeared on Medscape.com.
A rapid, saliva-based test for COVID-19 could enable testing, diagnosis, and prescribing to take place in a single office visit by immediately confirming whether a patient has the infection and needs to be treated, researchers say. The test has sparked commercial interest and earned additional funding from the Canadian government.
The test uses a DNA aptamer – a short, synthetic oligonucleotide that binds to a specific molecular target – that shows high affinity for the SARS-CoV-2 spike protein and its variants. The approach “can be rapidly adapted to different threats,” as well, Leyla Soleymani, PhD, an associate professor of engineering physics at McMaster University, Hamilton, Ontario, Canada, told this news organization. Her team invented the approach.
Adaptable to other pathogens
Current gold-standard COVID-19 tests are based on reverse transcription-polymerase chain reaction (RT-PCR), which are sensitive but costly, complicated, and require waiting at least a couple of days for results, according to Dr. Soleymani and colleagues. Rapid nucleic acid and antigen tests have only “moderate” sensitivity and specificity, particularly when viral loads are low. None have been shown to work well with saliva samples.
By contrast, the new test “uses a reader and test cartridges, similar to the glucose reader,” said Dr. Soleymani, who is also Canada Research chair in Miniaturized Biomedical Devices. A small sample of saliva is added to a chemical reagent and inserted into the reader, which is attached to a smartphone. Once commercialized, the point-of-care test is expected to be performed quickly in a physician’s office or in a clinic.
“The same reader can be applied to a variety of infectious diseases or infection panels by developing new cartridges,” Dr. Soleymani explained. “Noroviruses and bacteria such as C. difficile are on our list” to examine next.What’s more, she added, “this test is ideally positioned for settings where access to centralized labs is not possible, such as less developed countries.”
The team’s recent studies seem to support the promise. A study published last year in the international edition of Angewandte Chemie documents the development of the test, which at that point could detect wild-type SARS-CoV-2 and its Alpha and Delta variants in unprocessed saliva samples in 10 minutes with 80.5% sensitivity and 100% specificity.
This study was followed in January 2022 by a paper in Chemistry showing that the device also detected Alpha, Gamma, Epsilon, Kappa, and Omicron variants, demonstrating its potential for recognizing rapidly evolving targets such as those found in SARS-CoV-2.
In another demonstration of its versatility, the technology was recently adapted and successfully detected animal viruses from saliva samples.
Commercial and government funding
The findings prompted Zentek, an intellectual property development and commercialization company in Guelph, Ont., to license the technology, with plans to invest more than $1 million in the next 5 years to scale up production of the test components and adapt the technology for other forms of infection.
Furthermore, the collaborative efforts required to develop the test and move it forward gained funding from Canada’s Natural Sciences and Engineering Research Council, which is investing nearly $1.5 million in the form of two grants: $1 million to further streamline the technology development in preparation for the next pandemic and $488,440 (including $140,000 from Zentek) to get the current test to market as quickly as possible.
Meanwhile, Dr. Soleymani is urging clinicians “to be open to nontraditional diagnostic approaches even if the traditional tests do the job. Such tests are more rapid and can be used to enable personalized medicine. Our success relies on collaboration and support from clinicians.”
Further validation needed
Daniel Kuritzkes, MD, chief of infectious diseases at Brigham and Women’s Hospital and the Harriet Ryan Albee Professor of Medicine at Harvard Medical School, Boston, commented on the study in response to a request from this news organization.
While “it’s always good to have more testing options available,” he said, “we don’t yet have very much information about performance characteristics of the test – that is, its sensitivity and specificity. I’d like to see the performance characteristics of this test compared to PCR tests and to the current rapid antigen tests using a large number of patient samples with currently circulating variants, and tests over time to see how soon tests become positive after symptom onset and for how long they remain positive.”
“Further validation studies and emergency use authorization or approval by regulatory authorities are needed before we will see this test implemented in the field,” Dr. Kuritzkes concluded.
A version of this article first appeared on Medscape.com.
Doxycycline bests azithromycin for anorectal chlamydia in women
NEW YORK (Reuters) – A one-week course of doxycycline was superior to a single dose of azithromycin in women with concurrent vaginal and anorectal chlamydia infection in an unblinded randomized controlled trial, mirroring previous results in men.
Researchers suggest that doxycycline should be the first-line therapy for chlamydia infection in women.
“It is clear we must consider that any woman with a urogenital infection must have an effective treatment for the anal infection, since nearly 80% of women have an anal infection concomitant with the vaginal infection,” Dr. Bertille de Barbeyrac of the University of Bordeaux, France, told Reuters Health by email.
However, she noted that “even [though] the study shows that doxycycline is more effective than azithromycin on anal infection, other studies are needed to prove that residual anal infection after treatment with azithromycin can be a source of vaginal contamination and therefore justify changing practices and eliminating azithromycin as a treatment for lower urogenital chlamydial infection in women.”
“There are other reasons [to make] this change,” she added, “such as the acquisition of macrolide resistance by M. genitalium following heavy use of azithromycin.”
As reported in The Lancet Infectious Diseases, Dr. Barbeyrac and colleagues randomly assigned 460 women (median age, 21) to either doxycycline or azithromycin in a multicenter, open-label superiority trial.
Participants received either azithromycin (a single 1-g dose, with or without food) or doxycycline (100 mg in the morning and evening at mealtimes for 7 days – that is, 100 mg of doxycycline twice daily).
The primary outcome was that the microbiological anorectal cure rate, defined as a C. trachomatis-negative nucleic acid amplification test (NAAT), resulted in anorectal specimens six weeks after treatment initiation among women who had a baseline positive result (about half the women in each treatment group).
Ninety-four percent of the doxycycline group versus 85% of the azithromycin group had an anorectal cure (adjusted odds ratio with imputation of missing values, 0.43).
Adverse events possibly related to treatment occurred in 11% of the doxycycline group versus 13% of the azithromycin group. Gastrointestinal disorders were most frequent, occurring in 8% of the doxycycline and 11% of the azithromycin groups.
Summing up, the authors write, “The microbiological anorectal cure rate was significantly lower among women who received a single dose of azithromycin than among those who received a 1-week course of doxycycline. This finding suggests that doxycycline should be the first-line therapy for C trachomatis infection in women.”
Dr. Meleen Chuang, medical director of women’s health at the Family Health Centers at NYU Langone, Brooklyn, commented in an email to Reuters Health that after reviewing this study “as well as CDC and WHO recommendations updated as of 2022, health care providers should be treating C. trachomatis infections with doxycycline 100 mg twice a day for seven days as first-line therapy rather than azithromycin, [given] concerns of increasing macrolide drug resistance against Mycoplasma genitalium and Neisseria gonorrhea.”
“Our clinicians also see the growing uptick of syphilis, gonorrhea, and chlamydia infections in our population, similarly to the rest of the United States since 2020,” she noted. “With the increase in STD infection ... treatment with doxycycline therapy with an important caveat to the patient to complete the one-week treatment regimen is extremely important.”
Dr. Latasha Murphy of the Gynecologic Care Institute at Mercy, Baltimore, also commented in an email to Reuters Health. She noted, “this study does not mirror my clinical experience. More patients have side effects from doxycycline than azithromycin in my experience. Also, anorectal screening is not routine in STD screening.”
“If any major changes to clinical care are made,” she said, “it may be for more consistent screening for anorectal disease. This may ultimately lead to doxycycline being the first line-treatment. More research is needed before making any definitive changes.”
Reuters Health Information © 2022
NEW YORK (Reuters) – A one-week course of doxycycline was superior to a single dose of azithromycin in women with concurrent vaginal and anorectal chlamydia infection in an unblinded randomized controlled trial, mirroring previous results in men.
Researchers suggest that doxycycline should be the first-line therapy for chlamydia infection in women.
“It is clear we must consider that any woman with a urogenital infection must have an effective treatment for the anal infection, since nearly 80% of women have an anal infection concomitant with the vaginal infection,” Dr. Bertille de Barbeyrac of the University of Bordeaux, France, told Reuters Health by email.
However, she noted that “even [though] the study shows that doxycycline is more effective than azithromycin on anal infection, other studies are needed to prove that residual anal infection after treatment with azithromycin can be a source of vaginal contamination and therefore justify changing practices and eliminating azithromycin as a treatment for lower urogenital chlamydial infection in women.”
“There are other reasons [to make] this change,” she added, “such as the acquisition of macrolide resistance by M. genitalium following heavy use of azithromycin.”
As reported in The Lancet Infectious Diseases, Dr. Barbeyrac and colleagues randomly assigned 460 women (median age, 21) to either doxycycline or azithromycin in a multicenter, open-label superiority trial.
Participants received either azithromycin (a single 1-g dose, with or without food) or doxycycline (100 mg in the morning and evening at mealtimes for 7 days – that is, 100 mg of doxycycline twice daily).
The primary outcome was that the microbiological anorectal cure rate, defined as a C. trachomatis-negative nucleic acid amplification test (NAAT), resulted in anorectal specimens six weeks after treatment initiation among women who had a baseline positive result (about half the women in each treatment group).
Ninety-four percent of the doxycycline group versus 85% of the azithromycin group had an anorectal cure (adjusted odds ratio with imputation of missing values, 0.43).
Adverse events possibly related to treatment occurred in 11% of the doxycycline group versus 13% of the azithromycin group. Gastrointestinal disorders were most frequent, occurring in 8% of the doxycycline and 11% of the azithromycin groups.
Summing up, the authors write, “The microbiological anorectal cure rate was significantly lower among women who received a single dose of azithromycin than among those who received a 1-week course of doxycycline. This finding suggests that doxycycline should be the first-line therapy for C trachomatis infection in women.”
Dr. Meleen Chuang, medical director of women’s health at the Family Health Centers at NYU Langone, Brooklyn, commented in an email to Reuters Health that after reviewing this study “as well as CDC and WHO recommendations updated as of 2022, health care providers should be treating C. trachomatis infections with doxycycline 100 mg twice a day for seven days as first-line therapy rather than azithromycin, [given] concerns of increasing macrolide drug resistance against Mycoplasma genitalium and Neisseria gonorrhea.”
“Our clinicians also see the growing uptick of syphilis, gonorrhea, and chlamydia infections in our population, similarly to the rest of the United States since 2020,” she noted. “With the increase in STD infection ... treatment with doxycycline therapy with an important caveat to the patient to complete the one-week treatment regimen is extremely important.”
Dr. Latasha Murphy of the Gynecologic Care Institute at Mercy, Baltimore, also commented in an email to Reuters Health. She noted, “this study does not mirror my clinical experience. More patients have side effects from doxycycline than azithromycin in my experience. Also, anorectal screening is not routine in STD screening.”
“If any major changes to clinical care are made,” she said, “it may be for more consistent screening for anorectal disease. This may ultimately lead to doxycycline being the first line-treatment. More research is needed before making any definitive changes.”
Reuters Health Information © 2022
NEW YORK (Reuters) – A one-week course of doxycycline was superior to a single dose of azithromycin in women with concurrent vaginal and anorectal chlamydia infection in an unblinded randomized controlled trial, mirroring previous results in men.
Researchers suggest that doxycycline should be the first-line therapy for chlamydia infection in women.
“It is clear we must consider that any woman with a urogenital infection must have an effective treatment for the anal infection, since nearly 80% of women have an anal infection concomitant with the vaginal infection,” Dr. Bertille de Barbeyrac of the University of Bordeaux, France, told Reuters Health by email.
However, she noted that “even [though] the study shows that doxycycline is more effective than azithromycin on anal infection, other studies are needed to prove that residual anal infection after treatment with azithromycin can be a source of vaginal contamination and therefore justify changing practices and eliminating azithromycin as a treatment for lower urogenital chlamydial infection in women.”
“There are other reasons [to make] this change,” she added, “such as the acquisition of macrolide resistance by M. genitalium following heavy use of azithromycin.”
As reported in The Lancet Infectious Diseases, Dr. Barbeyrac and colleagues randomly assigned 460 women (median age, 21) to either doxycycline or azithromycin in a multicenter, open-label superiority trial.
Participants received either azithromycin (a single 1-g dose, with or without food) or doxycycline (100 mg in the morning and evening at mealtimes for 7 days – that is, 100 mg of doxycycline twice daily).
The primary outcome was that the microbiological anorectal cure rate, defined as a C. trachomatis-negative nucleic acid amplification test (NAAT), resulted in anorectal specimens six weeks after treatment initiation among women who had a baseline positive result (about half the women in each treatment group).
Ninety-four percent of the doxycycline group versus 85% of the azithromycin group had an anorectal cure (adjusted odds ratio with imputation of missing values, 0.43).
Adverse events possibly related to treatment occurred in 11% of the doxycycline group versus 13% of the azithromycin group. Gastrointestinal disorders were most frequent, occurring in 8% of the doxycycline and 11% of the azithromycin groups.
Summing up, the authors write, “The microbiological anorectal cure rate was significantly lower among women who received a single dose of azithromycin than among those who received a 1-week course of doxycycline. This finding suggests that doxycycline should be the first-line therapy for C trachomatis infection in women.”
Dr. Meleen Chuang, medical director of women’s health at the Family Health Centers at NYU Langone, Brooklyn, commented in an email to Reuters Health that after reviewing this study “as well as CDC and WHO recommendations updated as of 2022, health care providers should be treating C. trachomatis infections with doxycycline 100 mg twice a day for seven days as first-line therapy rather than azithromycin, [given] concerns of increasing macrolide drug resistance against Mycoplasma genitalium and Neisseria gonorrhea.”
“Our clinicians also see the growing uptick of syphilis, gonorrhea, and chlamydia infections in our population, similarly to the rest of the United States since 2020,” she noted. “With the increase in STD infection ... treatment with doxycycline therapy with an important caveat to the patient to complete the one-week treatment regimen is extremely important.”
Dr. Latasha Murphy of the Gynecologic Care Institute at Mercy, Baltimore, also commented in an email to Reuters Health. She noted, “this study does not mirror my clinical experience. More patients have side effects from doxycycline than azithromycin in my experience. Also, anorectal screening is not routine in STD screening.”
“If any major changes to clinical care are made,” she said, “it may be for more consistent screening for anorectal disease. This may ultimately lead to doxycycline being the first line-treatment. More research is needed before making any definitive changes.”
Reuters Health Information © 2022
Report Shows Implanted Cardioveter-defibrillators Carries High Risk
NEW YORK (Reuters Health) - Implanted cardioverter-defibrillators (ICDs) carry a high risk of long-term complications, especially for younger patients, women, and blacks, researchers report.
Early implantation-related risks such as device malfunction are well known, but longer-term risks -- especially beyond the first year after implantation -- are poorly defined, Dr. Isuru Ranasinghe of Queen Elizabeth Hospital in South Australia and colleagues observed in an article online May 2 in Annals of
Internal Medicine.
"Knowing the long-term risks is important for patients to make an informed choice, because (implantation) is a lifelong treatment," Dr. Ranasinghe told Reuters Health by email. "Moreover, more than two-thirds of patients who receive an ICD for prevention of future events never require treatment from the ICD, although they continue to be at risk for device-related harms."
To investigate, the researchers analyzed data from the American College of Cardiology Foundation's National Cardiovascular Data Registry ICD Registry and Medicare claims to assess the long-term nonfatal risks for ICD-related complications among 114,484 patients at 1,437 U.S. centers with first-time implantations.
Implanted devices included single-chamber ICDs (19.8% of patients); dual-chamber ICDs (41.3%), and cardiac resynchronization therapy with a defibrillator (CRT-D; 38.9%).
During a median follow-up of 2.7 years, 40,072 patients died, representing 12.6 deaths per 100 patient years of followup. After accounting for the deaths, "there were 6.1 ICD-related complications per 100 patient years where the patient required an acute hospitalization or a reoperation," Dr. Ranasinghe said.
"In addition, there were 3.9 device reoperations per 100 patient years for reasons other than complications. Typically performed to replace the ICD battery, these reoperations are somewhat expected with time. Nevertheless, these surgical procedures are important for patients, as they carry a risk of patient harm," he observed.
Those more likely to experience long-term complications were women (16% higher risk), blacks (14% higher risk), and patients ages 65-69 at implantation (55% higher risk compared with those 85 and older) -- findings that require further investigation, according to Dr. Ranasinghe.
"Patients were 38% more likely to experience a complication if they had the more complex CRT-D compared with a simpler (single-chamber) device. A patient with a CRT-D device was also four times more likely to require a reoperation for reasons other than complications compared with a single-chamber ICD during the study period," he said.
Dr Ranasinghe added, "The rate of complications is substantial and higher than previously reported. The continued occurrence of complications long after the initial implantation indicates the need for vigilance and ongoing surveillance of ICD-related complications."
"There is considerable debate as to the added benefit of more complex devices compared with simpler single-chamber ICDs. Where possible, using a simpler device may reduce the risk of ICD-related harm," he said.
Dr. Paul J. Hauptman of Saint Louis University School of Medicine in Missouri, told Reuters Health by email, "The study adds to a rich literature that highlights the need for clinicians and patients to carefully consider the potential risks and benefits of implantable defibrillators and CRT devices."
"Although (this was) not a primary focus of the paper, I was struck by the 35% mortality at a median of 2.7 years (in addition to a significant ICD-related complication rate)," said Dr. Hauptman, who has done work in this area. "By linking registry and Medicare data, the authors succeed in providing meaningful insight into what happens to real patients in the real world. We would be abrogating our role as physicians if we ignore analyses like this one."
The study was funded by the American College of Cardiology Foundation's National Cardiovascular Data Registry and other organizations. Five coauthors reported disclosures.
NEW YORK (Reuters Health) - Implanted cardioverter-defibrillators (ICDs) carry a high risk of long-term complications, especially for younger patients, women, and blacks, researchers report.
Early implantation-related risks such as device malfunction are well known, but longer-term risks -- especially beyond the first year after implantation -- are poorly defined, Dr. Isuru Ranasinghe of Queen Elizabeth Hospital in South Australia and colleagues observed in an article online May 2 in Annals of
Internal Medicine.
"Knowing the long-term risks is important for patients to make an informed choice, because (implantation) is a lifelong treatment," Dr. Ranasinghe told Reuters Health by email. "Moreover, more than two-thirds of patients who receive an ICD for prevention of future events never require treatment from the ICD, although they continue to be at risk for device-related harms."
To investigate, the researchers analyzed data from the American College of Cardiology Foundation's National Cardiovascular Data Registry ICD Registry and Medicare claims to assess the long-term nonfatal risks for ICD-related complications among 114,484 patients at 1,437 U.S. centers with first-time implantations.
Implanted devices included single-chamber ICDs (19.8% of patients); dual-chamber ICDs (41.3%), and cardiac resynchronization therapy with a defibrillator (CRT-D; 38.9%).
During a median follow-up of 2.7 years, 40,072 patients died, representing 12.6 deaths per 100 patient years of followup. After accounting for the deaths, "there were 6.1 ICD-related complications per 100 patient years where the patient required an acute hospitalization or a reoperation," Dr. Ranasinghe said.
"In addition, there were 3.9 device reoperations per 100 patient years for reasons other than complications. Typically performed to replace the ICD battery, these reoperations are somewhat expected with time. Nevertheless, these surgical procedures are important for patients, as they carry a risk of patient harm," he observed.
Those more likely to experience long-term complications were women (16% higher risk), blacks (14% higher risk), and patients ages 65-69 at implantation (55% higher risk compared with those 85 and older) -- findings that require further investigation, according to Dr. Ranasinghe.
"Patients were 38% more likely to experience a complication if they had the more complex CRT-D compared with a simpler (single-chamber) device. A patient with a CRT-D device was also four times more likely to require a reoperation for reasons other than complications compared with a single-chamber ICD during the study period," he said.
Dr Ranasinghe added, "The rate of complications is substantial and higher than previously reported. The continued occurrence of complications long after the initial implantation indicates the need for vigilance and ongoing surveillance of ICD-related complications."
"There is considerable debate as to the added benefit of more complex devices compared with simpler single-chamber ICDs. Where possible, using a simpler device may reduce the risk of ICD-related harm," he said.
Dr. Paul J. Hauptman of Saint Louis University School of Medicine in Missouri, told Reuters Health by email, "The study adds to a rich literature that highlights the need for clinicians and patients to carefully consider the potential risks and benefits of implantable defibrillators and CRT devices."
"Although (this was) not a primary focus of the paper, I was struck by the 35% mortality at a median of 2.7 years (in addition to a significant ICD-related complication rate)," said Dr. Hauptman, who has done work in this area. "By linking registry and Medicare data, the authors succeed in providing meaningful insight into what happens to real patients in the real world. We would be abrogating our role as physicians if we ignore analyses like this one."
The study was funded by the American College of Cardiology Foundation's National Cardiovascular Data Registry and other organizations. Five coauthors reported disclosures.
NEW YORK (Reuters Health) - Implanted cardioverter-defibrillators (ICDs) carry a high risk of long-term complications, especially for younger patients, women, and blacks, researchers report.
Early implantation-related risks such as device malfunction are well known, but longer-term risks -- especially beyond the first year after implantation -- are poorly defined, Dr. Isuru Ranasinghe of Queen Elizabeth Hospital in South Australia and colleagues observed in an article online May 2 in Annals of
Internal Medicine.
"Knowing the long-term risks is important for patients to make an informed choice, because (implantation) is a lifelong treatment," Dr. Ranasinghe told Reuters Health by email. "Moreover, more than two-thirds of patients who receive an ICD for prevention of future events never require treatment from the ICD, although they continue to be at risk for device-related harms."
To investigate, the researchers analyzed data from the American College of Cardiology Foundation's National Cardiovascular Data Registry ICD Registry and Medicare claims to assess the long-term nonfatal risks for ICD-related complications among 114,484 patients at 1,437 U.S. centers with first-time implantations.
Implanted devices included single-chamber ICDs (19.8% of patients); dual-chamber ICDs (41.3%), and cardiac resynchronization therapy with a defibrillator (CRT-D; 38.9%).
During a median follow-up of 2.7 years, 40,072 patients died, representing 12.6 deaths per 100 patient years of followup. After accounting for the deaths, "there were 6.1 ICD-related complications per 100 patient years where the patient required an acute hospitalization or a reoperation," Dr. Ranasinghe said.
"In addition, there were 3.9 device reoperations per 100 patient years for reasons other than complications. Typically performed to replace the ICD battery, these reoperations are somewhat expected with time. Nevertheless, these surgical procedures are important for patients, as they carry a risk of patient harm," he observed.
Those more likely to experience long-term complications were women (16% higher risk), blacks (14% higher risk), and patients ages 65-69 at implantation (55% higher risk compared with those 85 and older) -- findings that require further investigation, according to Dr. Ranasinghe.
"Patients were 38% more likely to experience a complication if they had the more complex CRT-D compared with a simpler (single-chamber) device. A patient with a CRT-D device was also four times more likely to require a reoperation for reasons other than complications compared with a single-chamber ICD during the study period," he said.
Dr Ranasinghe added, "The rate of complications is substantial and higher than previously reported. The continued occurrence of complications long after the initial implantation indicates the need for vigilance and ongoing surveillance of ICD-related complications."
"There is considerable debate as to the added benefit of more complex devices compared with simpler single-chamber ICDs. Where possible, using a simpler device may reduce the risk of ICD-related harm," he said.
Dr. Paul J. Hauptman of Saint Louis University School of Medicine in Missouri, told Reuters Health by email, "The study adds to a rich literature that highlights the need for clinicians and patients to carefully consider the potential risks and benefits of implantable defibrillators and CRT devices."
"Although (this was) not a primary focus of the paper, I was struck by the 35% mortality at a median of 2.7 years (in addition to a significant ICD-related complication rate)," said Dr. Hauptman, who has done work in this area. "By linking registry and Medicare data, the authors succeed in providing meaningful insight into what happens to real patients in the real world. We would be abrogating our role as physicians if we ignore analyses like this one."
The study was funded by the American College of Cardiology Foundation's National Cardiovascular Data Registry and other organizations. Five coauthors reported disclosures.
Metal-on-Metal Hip Replacement Devices Implanted after 2006 have a High Revision Rate
NEW YORK (Reuters Health) - Certain metal-on-metal (MoM) hip replacement devices implanted after 2006 have an "unacceptably high" revision rate, due mainly to manufacturing problems, according to a new study.
"Although the use of MoM hip devices has declined dramatically in the past five years, hundreds of thousands remain in situ, with the long-term future uncertain," Dr. David Langton, of University Hospital of North Tees in Stockton, UK, and colleagues wrote in an article online April 29 in BMJ Open.
To determine risk factors for revision in patients implanted with the commonly used DePuy Pinnacle MoM hip prostheses, the researchers identified all patients at the Stockton-based hospital who were implanted with a 36 mm MoM Pinnacle hip in conjunction with an S-ROM or Corail uncemented stem. They then identified only patients with components that had been implanted by either of the two senior authors of the study, Dr. Raj Logishetty or Dr. Antoni Viral Francis Nargol.
Implantations were performed from 2003-2009 and patients were monitored yearly. From 2007-2011, as awareness of the risk of adverse reactions to metal debris (ARMD) from MoMs increased, the hospital offered patients who developed symptoms blood metal ion testing and as-needed ultrasound scanning. From 2011 onward, given the widespread problems reported with MoMs, the hospital recalled all Pinnacle MoM patients for examination.
A total of 489 MoM Pinnacle hips had been implanted into 243 women and 191 men. Of these, 352 patients attended the MoM recall clinics and 64 died during the study period (mean
followup, about 7.5 years). For the purposes of survival analyses, those who did not attend the recall clinics were assumed to have well-functioning prostheses.
A total of 71 hips were revised -- an "unacceptably high" rate, according to the authors. All but one were carried out for ARMD, with one revision for a loose cup. Prosthetic survival rate for the cohort as a whole was 83.6% at nine years.
In 53 revisions (75%), "copious amounts" of fluid were found, and in 32 (45%), it was noted to be under pressure or had fistulated through the capsule. No abnormal fluid was identified at revision in only one case.
The researchers noted obvious damage to the abductor musculature in 38 cases. They documented a moderate-to-severe aseptic lymphocyte-dominated vasculitis-associated lesion on examination of retrieved tissues in 36 cases (51%). In 13 cases (19%), they found metallosis with no identified lymphocytic infiltration.
The majority of explanted devices showed signs of taper junction failure. A significant number of devices were found to be manufactured out of their specifications -- a finding that was confirmed by an analysis of a wider data set from the Northern Retrieval Registry.
Risk factors for revision were bilateral MoM prostheses, smaller Pinnacle liners, and implantation in 2006 or later. Women were found to be at greater risk of early device failure. However, shell sizes and bearing diameters confounded the analyses, and liner size and/or earlier year of liner manufacture were determined to be greater threats to prosthetic survival than gender. The authors suggest that this analysis be repeated with input from an additional registry.
Dr. Langton, who is involved in litigation related to the Pinnacle device, told Reuters Health by email, "We have essentially shown that one of the major health care/orthopedic product manufacturers sold a product to surgeons and health care systems on the basis (that it was a) technologically advanced precision-engineered device, and it wasn't precision-engineered."
He added, "the product was produced in the same factories as (DePuy's) other failed product, the ASR, which was . . . marketed on the same premise."
Mindy Tinsley, senior director, Communications and Public Affairs at DePuy Synthes Franchise, refuted the study findings. "We stand behind the strong record of safety and effectiveness of the (Pinnacle) ULTAMET Metal-on-Metal," she told Reuters Health by email.
She added that "there are no manufacturing problems" with the device and noted that DePuy "questions the validity of the . . . paper given significant flaws in how it was conducted." According to Tinsley, "measurements taken following an accepted international standard at the DePuy UK manufacturing facility" showed the device liners "were manufactured within specification."
Dr. Mark W. Hungerford, director of Joint Replacement and Reconstruction at Mercy Medical Center in Baltimore, told Reuters Health by phone, "One study does not make or break anything in science. There have been issues in the field about MoM and early failure rates or not. That's a serious issue being looked at by a lot of people. This is one more study showing a problem, but it's not a definitive one."
With respect to patients, "the obligation is no different than for any orthopedic device," said Dr. Hungerford, who has not used the Pinnacle device. "All can fail, all need to be monitored for failure on a regular basis, and if problems arise, they need to be dealt with."
The authors reported no funding. Dr. Langton, Dr. Nargol, and coauthors Dr. Thomas Joyce and Dr. Nick Cooke are retained experts for plaintiffs in ongoing MoM litigation. Dr. Langton and Dr. Nargol have worked with the U.S. Department of Justice in litigation involving DePuy.
NEW YORK (Reuters Health) - Certain metal-on-metal (MoM) hip replacement devices implanted after 2006 have an "unacceptably high" revision rate, due mainly to manufacturing problems, according to a new study.
"Although the use of MoM hip devices has declined dramatically in the past five years, hundreds of thousands remain in situ, with the long-term future uncertain," Dr. David Langton, of University Hospital of North Tees in Stockton, UK, and colleagues wrote in an article online April 29 in BMJ Open.
To determine risk factors for revision in patients implanted with the commonly used DePuy Pinnacle MoM hip prostheses, the researchers identified all patients at the Stockton-based hospital who were implanted with a 36 mm MoM Pinnacle hip in conjunction with an S-ROM or Corail uncemented stem. They then identified only patients with components that had been implanted by either of the two senior authors of the study, Dr. Raj Logishetty or Dr. Antoni Viral Francis Nargol.
Implantations were performed from 2003-2009 and patients were monitored yearly. From 2007-2011, as awareness of the risk of adverse reactions to metal debris (ARMD) from MoMs increased, the hospital offered patients who developed symptoms blood metal ion testing and as-needed ultrasound scanning. From 2011 onward, given the widespread problems reported with MoMs, the hospital recalled all Pinnacle MoM patients for examination.
A total of 489 MoM Pinnacle hips had been implanted into 243 women and 191 men. Of these, 352 patients attended the MoM recall clinics and 64 died during the study period (mean
followup, about 7.5 years). For the purposes of survival analyses, those who did not attend the recall clinics were assumed to have well-functioning prostheses.
A total of 71 hips were revised -- an "unacceptably high" rate, according to the authors. All but one were carried out for ARMD, with one revision for a loose cup. Prosthetic survival rate for the cohort as a whole was 83.6% at nine years.
In 53 revisions (75%), "copious amounts" of fluid were found, and in 32 (45%), it was noted to be under pressure or had fistulated through the capsule. No abnormal fluid was identified at revision in only one case.
The researchers noted obvious damage to the abductor musculature in 38 cases. They documented a moderate-to-severe aseptic lymphocyte-dominated vasculitis-associated lesion on examination of retrieved tissues in 36 cases (51%). In 13 cases (19%), they found metallosis with no identified lymphocytic infiltration.
The majority of explanted devices showed signs of taper junction failure. A significant number of devices were found to be manufactured out of their specifications -- a finding that was confirmed by an analysis of a wider data set from the Northern Retrieval Registry.
Risk factors for revision were bilateral MoM prostheses, smaller Pinnacle liners, and implantation in 2006 or later. Women were found to be at greater risk of early device failure. However, shell sizes and bearing diameters confounded the analyses, and liner size and/or earlier year of liner manufacture were determined to be greater threats to prosthetic survival than gender. The authors suggest that this analysis be repeated with input from an additional registry.
Dr. Langton, who is involved in litigation related to the Pinnacle device, told Reuters Health by email, "We have essentially shown that one of the major health care/orthopedic product manufacturers sold a product to surgeons and health care systems on the basis (that it was a) technologically advanced precision-engineered device, and it wasn't precision-engineered."
He added, "the product was produced in the same factories as (DePuy's) other failed product, the ASR, which was . . . marketed on the same premise."
Mindy Tinsley, senior director, Communications and Public Affairs at DePuy Synthes Franchise, refuted the study findings. "We stand behind the strong record of safety and effectiveness of the (Pinnacle) ULTAMET Metal-on-Metal," she told Reuters Health by email.
She added that "there are no manufacturing problems" with the device and noted that DePuy "questions the validity of the . . . paper given significant flaws in how it was conducted." According to Tinsley, "measurements taken following an accepted international standard at the DePuy UK manufacturing facility" showed the device liners "were manufactured within specification."
Dr. Mark W. Hungerford, director of Joint Replacement and Reconstruction at Mercy Medical Center in Baltimore, told Reuters Health by phone, "One study does not make or break anything in science. There have been issues in the field about MoM and early failure rates or not. That's a serious issue being looked at by a lot of people. This is one more study showing a problem, but it's not a definitive one."
With respect to patients, "the obligation is no different than for any orthopedic device," said Dr. Hungerford, who has not used the Pinnacle device. "All can fail, all need to be monitored for failure on a regular basis, and if problems arise, they need to be dealt with."
The authors reported no funding. Dr. Langton, Dr. Nargol, and coauthors Dr. Thomas Joyce and Dr. Nick Cooke are retained experts for plaintiffs in ongoing MoM litigation. Dr. Langton and Dr. Nargol have worked with the U.S. Department of Justice in litigation involving DePuy.
NEW YORK (Reuters Health) - Certain metal-on-metal (MoM) hip replacement devices implanted after 2006 have an "unacceptably high" revision rate, due mainly to manufacturing problems, according to a new study.
"Although the use of MoM hip devices has declined dramatically in the past five years, hundreds of thousands remain in situ, with the long-term future uncertain," Dr. David Langton, of University Hospital of North Tees in Stockton, UK, and colleagues wrote in an article online April 29 in BMJ Open.
To determine risk factors for revision in patients implanted with the commonly used DePuy Pinnacle MoM hip prostheses, the researchers identified all patients at the Stockton-based hospital who were implanted with a 36 mm MoM Pinnacle hip in conjunction with an S-ROM or Corail uncemented stem. They then identified only patients with components that had been implanted by either of the two senior authors of the study, Dr. Raj Logishetty or Dr. Antoni Viral Francis Nargol.
Implantations were performed from 2003-2009 and patients were monitored yearly. From 2007-2011, as awareness of the risk of adverse reactions to metal debris (ARMD) from MoMs increased, the hospital offered patients who developed symptoms blood metal ion testing and as-needed ultrasound scanning. From 2011 onward, given the widespread problems reported with MoMs, the hospital recalled all Pinnacle MoM patients for examination.
A total of 489 MoM Pinnacle hips had been implanted into 243 women and 191 men. Of these, 352 patients attended the MoM recall clinics and 64 died during the study period (mean
followup, about 7.5 years). For the purposes of survival analyses, those who did not attend the recall clinics were assumed to have well-functioning prostheses.
A total of 71 hips were revised -- an "unacceptably high" rate, according to the authors. All but one were carried out for ARMD, with one revision for a loose cup. Prosthetic survival rate for the cohort as a whole was 83.6% at nine years.
In 53 revisions (75%), "copious amounts" of fluid were found, and in 32 (45%), it was noted to be under pressure or had fistulated through the capsule. No abnormal fluid was identified at revision in only one case.
The researchers noted obvious damage to the abductor musculature in 38 cases. They documented a moderate-to-severe aseptic lymphocyte-dominated vasculitis-associated lesion on examination of retrieved tissues in 36 cases (51%). In 13 cases (19%), they found metallosis with no identified lymphocytic infiltration.
The majority of explanted devices showed signs of taper junction failure. A significant number of devices were found to be manufactured out of their specifications -- a finding that was confirmed by an analysis of a wider data set from the Northern Retrieval Registry.
Risk factors for revision were bilateral MoM prostheses, smaller Pinnacle liners, and implantation in 2006 or later. Women were found to be at greater risk of early device failure. However, shell sizes and bearing diameters confounded the analyses, and liner size and/or earlier year of liner manufacture were determined to be greater threats to prosthetic survival than gender. The authors suggest that this analysis be repeated with input from an additional registry.
Dr. Langton, who is involved in litigation related to the Pinnacle device, told Reuters Health by email, "We have essentially shown that one of the major health care/orthopedic product manufacturers sold a product to surgeons and health care systems on the basis (that it was a) technologically advanced precision-engineered device, and it wasn't precision-engineered."
He added, "the product was produced in the same factories as (DePuy's) other failed product, the ASR, which was . . . marketed on the same premise."
Mindy Tinsley, senior director, Communications and Public Affairs at DePuy Synthes Franchise, refuted the study findings. "We stand behind the strong record of safety and effectiveness of the (Pinnacle) ULTAMET Metal-on-Metal," she told Reuters Health by email.
She added that "there are no manufacturing problems" with the device and noted that DePuy "questions the validity of the . . . paper given significant flaws in how it was conducted." According to Tinsley, "measurements taken following an accepted international standard at the DePuy UK manufacturing facility" showed the device liners "were manufactured within specification."
Dr. Mark W. Hungerford, director of Joint Replacement and Reconstruction at Mercy Medical Center in Baltimore, told Reuters Health by phone, "One study does not make or break anything in science. There have been issues in the field about MoM and early failure rates or not. That's a serious issue being looked at by a lot of people. This is one more study showing a problem, but it's not a definitive one."
With respect to patients, "the obligation is no different than for any orthopedic device," said Dr. Hungerford, who has not used the Pinnacle device. "All can fail, all need to be monitored for failure on a regular basis, and if problems arise, they need to be dealt with."
The authors reported no funding. Dr. Langton, Dr. Nargol, and coauthors Dr. Thomas Joyce and Dr. Nick Cooke are retained experts for plaintiffs in ongoing MoM litigation. Dr. Langton and Dr. Nargol have worked with the U.S. Department of Justice in litigation involving DePuy.
Study Shows Certain Elderly Patients on Warfarin Therapy are at Greater Risk for Traumatic Intracranial Bleeding
NEW YORK (Reuters Health) - Certain older patients on warfarin therapy are at greater risk than others for traumatic intracranial bleeding, Veterans Affairs researchers have reported.
In their study of elderly adults receiving warfarin for atrial fibrillation (AF), five factors - dementia, anemia, depression, anticonvulsant use, and labile international normalized ratio - each made patients more vulnerable to traumatic intracranial bleeding.
"Advanced age is a powerful risk factor for thromboembolic stroke in patients with AF, and oral anticoagulation reduces this risk by almost two-thirds in patients at risk," the authors wrote. "However, up to half of the eligible older adults with AF are not treated with anticoagulant therapy due to health care professionals' concerns about potential treatment-related harms."
The research team reviewed medical and administrative data for 31,951 U.S. veterans with AF. Patients were 75 or older andwere newly referred to an anticoagulation clinic for warfarin therapy. Most had comorbidities, including hypertension (82.5%), coronary artery disease (42.6%) and diabetes (33.8%).
During the 11-year study period, 2002 through 2012, the incidence rate of hospitalization for traumatic intracranial bleeding was 4.80 per 1,000 person-years. The incidence rates for any intracranial bleeding and ischemic stroke were 14.58 and 13.44, respectively, per 1,000 person-years, the researchers reported online March 9 in JAMA Cardiology.
After adjusting for age, sex, race/ethnicity, and common comorbidities, significant predictors for traumatic intracranial bleeding were dementia (hazard ratio 1.76, p<0.01), anemia (HR 1.23, p<0.05), depression (HR 1.30, p<0.05), anticonvulsant use (HR 1.35, p<0.05), and labile international normalized ratio (HR 1.33, p<0.05).
"The differential risk between traumatic intracranial bleeding and ischemic stroke for those on warfarin therapy was lower than in prior studies, although the rate of ischemic stroke in our population was still considerable," senior author Dr. John Dodson, director of the Geriatric Cardiology Program at New York University School of Medicine, New York City, told Reuters Health by email.
"Of note, the most commonly used stroke risk score, CHA2S2-VASc, does a poor job of predicting risk for traumatic intracranial bleeding," he added. "Therefore, the risk factors appear to be distinct."
"For the practicing clinician, I think our findings underscore the need for a personalized approach to patients, potentially incorporating the risk factors we identified for traumatic intracranial bleeding in conversations around the risk versus benefit of warfarin therapy," Dr. Dodson said.
Dr. Dodson further noted that several oral anticoagulants have been approved in recent years that don't require the dose adjustment and monitoring needed with warfarin. "When we began this study, these drugs were very new and we therefore did not have a sufficient length of observation to generate a large enough sample of patients taking these medications."
"There are also implantable devices that have recently been approved that exclude the left atrial appendage, which is where most cerebroembolic phenomena originate from the circulation. We cannot comment on the relative harms of either of these strategies compared with warfarin in our data set," he acknowledged."
The final option would be to not treat - that is, taking a conservative approach with no medications or procedure - in a patient at particularly high risk for treatment-related harms, if this is concordant with the patient's own preferences," he concluded.
Dr. Vivek Reddy, director of Cardiac Arrhythmia Services at the Mount Sinai Health System and professor of medicine at the Icahn School of Medicine at Mount Sinai in New York City, also noted that clinicians have alternatives to warfarin. "We now have new oral anticoagulants (dabigatran, rivaroxaban, apixaban and edoxaban), but since they are also anticoagulants, it is unknown if the risk of traumatic bleeding would be lower in these patients," he told Reuters Health by email.
Of the mechanical left atrial appendage closure device, Dr. Reddy, who was not involved in the study, stated, "the data is quite compelling for patients that are not good candidates for oral anticoagulation - and the elderly population seems to be a population that would particularly benefit."
Dr. Reddy also pointed out, as did the authors, that the findings may not be applicable to women because 98% of those studied were men. He also observed that "virtually all (participants) were Caucasian, so it's not known if there would be differences for other ethnicities."
The National Institutes of Health and a number of other organizations supported this research. One coauthor reported disclosures.
NEW YORK (Reuters Health) - Certain older patients on warfarin therapy are at greater risk than others for traumatic intracranial bleeding, Veterans Affairs researchers have reported.
In their study of elderly adults receiving warfarin for atrial fibrillation (AF), five factors - dementia, anemia, depression, anticonvulsant use, and labile international normalized ratio - each made patients more vulnerable to traumatic intracranial bleeding.
"Advanced age is a powerful risk factor for thromboembolic stroke in patients with AF, and oral anticoagulation reduces this risk by almost two-thirds in patients at risk," the authors wrote. "However, up to half of the eligible older adults with AF are not treated with anticoagulant therapy due to health care professionals' concerns about potential treatment-related harms."
The research team reviewed medical and administrative data for 31,951 U.S. veterans with AF. Patients were 75 or older andwere newly referred to an anticoagulation clinic for warfarin therapy. Most had comorbidities, including hypertension (82.5%), coronary artery disease (42.6%) and diabetes (33.8%).
During the 11-year study period, 2002 through 2012, the incidence rate of hospitalization for traumatic intracranial bleeding was 4.80 per 1,000 person-years. The incidence rates for any intracranial bleeding and ischemic stroke were 14.58 and 13.44, respectively, per 1,000 person-years, the researchers reported online March 9 in JAMA Cardiology.
After adjusting for age, sex, race/ethnicity, and common comorbidities, significant predictors for traumatic intracranial bleeding were dementia (hazard ratio 1.76, p<0.01), anemia (HR 1.23, p<0.05), depression (HR 1.30, p<0.05), anticonvulsant use (HR 1.35, p<0.05), and labile international normalized ratio (HR 1.33, p<0.05).
"The differential risk between traumatic intracranial bleeding and ischemic stroke for those on warfarin therapy was lower than in prior studies, although the rate of ischemic stroke in our population was still considerable," senior author Dr. John Dodson, director of the Geriatric Cardiology Program at New York University School of Medicine, New York City, told Reuters Health by email.
"Of note, the most commonly used stroke risk score, CHA2S2-VASc, does a poor job of predicting risk for traumatic intracranial bleeding," he added. "Therefore, the risk factors appear to be distinct."
"For the practicing clinician, I think our findings underscore the need for a personalized approach to patients, potentially incorporating the risk factors we identified for traumatic intracranial bleeding in conversations around the risk versus benefit of warfarin therapy," Dr. Dodson said.
Dr. Dodson further noted that several oral anticoagulants have been approved in recent years that don't require the dose adjustment and monitoring needed with warfarin. "When we began this study, these drugs were very new and we therefore did not have a sufficient length of observation to generate a large enough sample of patients taking these medications."
"There are also implantable devices that have recently been approved that exclude the left atrial appendage, which is where most cerebroembolic phenomena originate from the circulation. We cannot comment on the relative harms of either of these strategies compared with warfarin in our data set," he acknowledged."
The final option would be to not treat - that is, taking a conservative approach with no medications or procedure - in a patient at particularly high risk for treatment-related harms, if this is concordant with the patient's own preferences," he concluded.
Dr. Vivek Reddy, director of Cardiac Arrhythmia Services at the Mount Sinai Health System and professor of medicine at the Icahn School of Medicine at Mount Sinai in New York City, also noted that clinicians have alternatives to warfarin. "We now have new oral anticoagulants (dabigatran, rivaroxaban, apixaban and edoxaban), but since they are also anticoagulants, it is unknown if the risk of traumatic bleeding would be lower in these patients," he told Reuters Health by email.
Of the mechanical left atrial appendage closure device, Dr. Reddy, who was not involved in the study, stated, "the data is quite compelling for patients that are not good candidates for oral anticoagulation - and the elderly population seems to be a population that would particularly benefit."
Dr. Reddy also pointed out, as did the authors, that the findings may not be applicable to women because 98% of those studied were men. He also observed that "virtually all (participants) were Caucasian, so it's not known if there would be differences for other ethnicities."
The National Institutes of Health and a number of other organizations supported this research. One coauthor reported disclosures.
NEW YORK (Reuters Health) - Certain older patients on warfarin therapy are at greater risk than others for traumatic intracranial bleeding, Veterans Affairs researchers have reported.
In their study of elderly adults receiving warfarin for atrial fibrillation (AF), five factors - dementia, anemia, depression, anticonvulsant use, and labile international normalized ratio - each made patients more vulnerable to traumatic intracranial bleeding.
"Advanced age is a powerful risk factor for thromboembolic stroke in patients with AF, and oral anticoagulation reduces this risk by almost two-thirds in patients at risk," the authors wrote. "However, up to half of the eligible older adults with AF are not treated with anticoagulant therapy due to health care professionals' concerns about potential treatment-related harms."
The research team reviewed medical and administrative data for 31,951 U.S. veterans with AF. Patients were 75 or older andwere newly referred to an anticoagulation clinic for warfarin therapy. Most had comorbidities, including hypertension (82.5%), coronary artery disease (42.6%) and diabetes (33.8%).
During the 11-year study period, 2002 through 2012, the incidence rate of hospitalization for traumatic intracranial bleeding was 4.80 per 1,000 person-years. The incidence rates for any intracranial bleeding and ischemic stroke were 14.58 and 13.44, respectively, per 1,000 person-years, the researchers reported online March 9 in JAMA Cardiology.
After adjusting for age, sex, race/ethnicity, and common comorbidities, significant predictors for traumatic intracranial bleeding were dementia (hazard ratio 1.76, p<0.01), anemia (HR 1.23, p<0.05), depression (HR 1.30, p<0.05), anticonvulsant use (HR 1.35, p<0.05), and labile international normalized ratio (HR 1.33, p<0.05).
"The differential risk between traumatic intracranial bleeding and ischemic stroke for those on warfarin therapy was lower than in prior studies, although the rate of ischemic stroke in our population was still considerable," senior author Dr. John Dodson, director of the Geriatric Cardiology Program at New York University School of Medicine, New York City, told Reuters Health by email.
"Of note, the most commonly used stroke risk score, CHA2S2-VASc, does a poor job of predicting risk for traumatic intracranial bleeding," he added. "Therefore, the risk factors appear to be distinct."
"For the practicing clinician, I think our findings underscore the need for a personalized approach to patients, potentially incorporating the risk factors we identified for traumatic intracranial bleeding in conversations around the risk versus benefit of warfarin therapy," Dr. Dodson said.
Dr. Dodson further noted that several oral anticoagulants have been approved in recent years that don't require the dose adjustment and monitoring needed with warfarin. "When we began this study, these drugs were very new and we therefore did not have a sufficient length of observation to generate a large enough sample of patients taking these medications."
"There are also implantable devices that have recently been approved that exclude the left atrial appendage, which is where most cerebroembolic phenomena originate from the circulation. We cannot comment on the relative harms of either of these strategies compared with warfarin in our data set," he acknowledged."
The final option would be to not treat - that is, taking a conservative approach with no medications or procedure - in a patient at particularly high risk for treatment-related harms, if this is concordant with the patient's own preferences," he concluded.
Dr. Vivek Reddy, director of Cardiac Arrhythmia Services at the Mount Sinai Health System and professor of medicine at the Icahn School of Medicine at Mount Sinai in New York City, also noted that clinicians have alternatives to warfarin. "We now have new oral anticoagulants (dabigatran, rivaroxaban, apixaban and edoxaban), but since they are also anticoagulants, it is unknown if the risk of traumatic bleeding would be lower in these patients," he told Reuters Health by email.
Of the mechanical left atrial appendage closure device, Dr. Reddy, who was not involved in the study, stated, "the data is quite compelling for patients that are not good candidates for oral anticoagulation - and the elderly population seems to be a population that would particularly benefit."
Dr. Reddy also pointed out, as did the authors, that the findings may not be applicable to women because 98% of those studied were men. He also observed that "virtually all (participants) were Caucasian, so it's not known if there would be differences for other ethnicities."
The National Institutes of Health and a number of other organizations supported this research. One coauthor reported disclosures.