Heart Failure

More than 18 months after the Watchman FLX device was licensed by the Food and Drug Administration for closure of the left atrial appendage (LAA), a prospective analysis of registry data presented at CRT 2022, sponsored by MedStar Heart & Vascular Institute, supports its safely outside of the clinical trial setting.

The data, drawn from the LAA occlusion registry of the National Cardiovascular Data Registry, showed a mortality rate at 45 days of under 1.0%, which was consistent with the acceptably low rate of other adverse events, according to Samir R. Kapadia, MD, chair of cardiovascular medicine at the Cleveland Clinic.

Only 0.5% had a pericardial effusion within 45 days of LAA closure that required intervention. Of those without effusion, 95% had a leak of less than 3 mm and 82% had no leak at all, according to Dr. Kapadia.

Patients enrolled in this analysis, called SURPASS (Surveillance Post Approval Analysis Plan), had undergone left atrial closure with the device from August 2020 to September 2022. There were no exclusion criteria. Ultimately, 2 years of follow-up is planned.

With more than 16,000 patients enrolled, the data on 14,363 patients in this initial 45-day analysis represents “the largest number of Watchman FLX patients evaluated to date,” Dr. Kapadia reported.
 

Device implantation success 97.5%

The Watchman FLX, which is delivered to the left atrial appendage by a transcatheter approach, was deployed successfully in 97.5% of all 16,048 patients enrolled in the registry. In the 398 cases without successful deployment, the anatomy was not conducive in nearly 70%. Other reasons included failure to meet device-release criteria and change in patient condition.

The outcomes of interest at 45 days were ischemic strokes, systemic emboli, device-related thrombi, device embolization, and bleeding. The primary endpoints at 2 years will be strokes and thrombotic events.

For stroke, the incidence within 45 days was 0.39%. About 25% of the strokes were hemorrhagic and the remainder were ischemic. There was 1 systemic embolism (0.01%), 5 device embolizations (0.03%), and 30 device-related thrombotic events (0.24%). Major bleeding occurred in 508 patients (3.55%).

For context, Dr. Kapadia compared these results to those observed in the PINNACLE FLX trial, which was a nonrandomized but prospective study of the Watchman FLX published about 1 year ago. In PINNACLE FLX, the enrollment was open to patients indicated for oral anticoagulation but who had an appropriate rationale for seeking a nonpharmacological alternative.

Taken from different studies, the outcomes at 45 days should not be construed as a direct comparison, but the similarity of the results can be considered reassuring, according to Dr. Kapadia.

For the composite safety endpoint of all-cause death, ischemic stroke, systemic embolism, or implantation-related events requiring intervention, the rates in SURPASS (0.4%) and PINNACLE FLX (0.5%) were nearly identical. Device leak rates (82.0% vs. 82.8%), stroke rates (0.4% vs. 0.7%), and all-cause death rates (0.9% vs. 0.5%) were also similar.

The similarity of the SURPASS and PINNACLE FLX data provides another level of reassurance.

“The SURPASS registry confirms the safety of the Watchman Flex in the real-world experience when the device is being used by many different operators in a large patient population,” Dr. Kapadia said in an interview.

In “appropriately selected patients,” the SURPASS data confirm that the Watchman FLX device “provides a safe and effective treatment option,” he added.

Relative to the PINNACLE FLX study, which enrolled 400 patients, it is noteworthy that the median age in SURPASS was older (76 vs. 73.8 years), a potential disadvantage in demonstrating comparable safety. The proportion of non-White patients was similar (6.7% vs. 6.3%). SURPASS had a higher proportion of women (40% vs. 35.5%).

Mitchel L. Zoler/MDedge News

The SURPASS data are credible, according to Vivek Y. Reddy, MD, director of cardiac arrhythmia services, Mount Sinai Health System, New York.

“While there are certainly limitations to registry data, I do feel pretty confident that these procedural complication and success rates [in SURPASS] do indeed reflect reality,” said Dr. Reddy, who was a coauthor of the PINNACLE FLX trial. In general, the SURPASS data “mirror most of our clinical experiences in routine clinical practice.”

With these registry data backing up multiple clinical studies, Dr. Reddy concluded, “I do believe that it is fair to say that Watchman-FLX implantation is a quite safe procedure.”

Dr. Kapadia reported no potential conflicts of interest. Dr. Reddy reported a financial relationship with Boston Scientific.

More than 18 months after the Watchman FLX device was licensed by the Food and Drug Administration for closure of the left atrial appendage (LAA), a prospective analysis of registry data presented at CRT 2022, sponsored by MedStar Heart & Vascular Institute, supports its safely outside of the clinical trial setting.

The data, drawn from the LAA occlusion registry of the National Cardiovascular Data Registry, showed a mortality rate at 45 days of under 1.0%, which was consistent with the acceptably low rate of other adverse events, according to Samir R. Kapadia, MD, chair of cardiovascular medicine at the Cleveland Clinic.

Only 0.5% had a pericardial effusion within 45 days of LAA closure that required intervention. Of those without effusion, 95% had a leak of less than 3 mm and 82% had no leak at all, according to Dr. Kapadia.

Patients enrolled in this analysis, called SURPASS (Surveillance Post Approval Analysis Plan), had undergone left atrial closure with the device from August 2020 to September 2022. There were no exclusion criteria. Ultimately, 2 years of follow-up is planned.

With more than 16,000 patients enrolled, the data on 14,363 patients in this initial 45-day analysis represents “the largest number of Watchman FLX patients evaluated to date,” Dr. Kapadia reported.
 

Device implantation success 97.5%

The Watchman FLX, which is delivered to the left atrial appendage by a transcatheter approach, was deployed successfully in 97.5% of all 16,048 patients enrolled in the registry. In the 398 cases without successful deployment, the anatomy was not conducive in nearly 70%. Other reasons included failure to meet device-release criteria and change in patient condition.

The outcomes of interest at 45 days were ischemic strokes, systemic emboli, device-related thrombi, device embolization, and bleeding. The primary endpoints at 2 years will be strokes and thrombotic events.

For stroke, the incidence within 45 days was 0.39%. About 25% of the strokes were hemorrhagic and the remainder were ischemic. There was 1 systemic embolism (0.01%), 5 device embolizations (0.03%), and 30 device-related thrombotic events (0.24%). Major bleeding occurred in 508 patients (3.55%).

For context, Dr. Kapadia compared these results to those observed in the PINNACLE FLX trial, which was a nonrandomized but prospective study of the Watchman FLX published about 1 year ago. In PINNACLE FLX, the enrollment was open to patients indicated for oral anticoagulation but who had an appropriate rationale for seeking a nonpharmacological alternative.

Taken from different studies, the outcomes at 45 days should not be construed as a direct comparison, but the similarity of the results can be considered reassuring, according to Dr. Kapadia.

For the composite safety endpoint of all-cause death, ischemic stroke, systemic embolism, or implantation-related events requiring intervention, the rates in SURPASS (0.4%) and PINNACLE FLX (0.5%) were nearly identical. Device leak rates (82.0% vs. 82.8%), stroke rates (0.4% vs. 0.7%), and all-cause death rates (0.9% vs. 0.5%) were also similar.

The similarity of the SURPASS and PINNACLE FLX data provides another level of reassurance.

“The SURPASS registry confirms the safety of the Watchman Flex in the real-world experience when the device is being used by many different operators in a large patient population,” Dr. Kapadia said in an interview.

In “appropriately selected patients,” the SURPASS data confirm that the Watchman FLX device “provides a safe and effective treatment option,” he added.

Relative to the PINNACLE FLX study, which enrolled 400 patients, it is noteworthy that the median age in SURPASS was older (76 vs. 73.8 years), a potential disadvantage in demonstrating comparable safety. The proportion of non-White patients was similar (6.7% vs. 6.3%). SURPASS had a higher proportion of women (40% vs. 35.5%).

Mitchel L. Zoler/MDedge News

The SURPASS data are credible, according to Vivek Y. Reddy, MD, director of cardiac arrhythmia services, Mount Sinai Health System, New York.

“While there are certainly limitations to registry data, I do feel pretty confident that these procedural complication and success rates [in SURPASS] do indeed reflect reality,” said Dr. Reddy, who was a coauthor of the PINNACLE FLX trial. In general, the SURPASS data “mirror most of our clinical experiences in routine clinical practice.”

With these registry data backing up multiple clinical studies, Dr. Reddy concluded, “I do believe that it is fair to say that Watchman-FLX implantation is a quite safe procedure.”

Dr. Kapadia reported no potential conflicts of interest. Dr. Reddy reported a financial relationship with Boston Scientific.

More than 18 months after the Watchman FLX device was licensed by the Food and Drug Administration for closure of the left atrial appendage (LAA), a prospective analysis of registry data presented at CRT 2022, sponsored by MedStar Heart & Vascular Institute, supports its safely outside of the clinical trial setting.

The data, drawn from the LAA occlusion registry of the National Cardiovascular Data Registry, showed a mortality rate at 45 days of under 1.0%, which was consistent with the acceptably low rate of other adverse events, according to Samir R. Kapadia, MD, chair of cardiovascular medicine at the Cleveland Clinic.

Only 0.5% had a pericardial effusion within 45 days of LAA closure that required intervention. Of those without effusion, 95% had a leak of less than 3 mm and 82% had no leak at all, according to Dr. Kapadia.

Patients enrolled in this analysis, called SURPASS (Surveillance Post Approval Analysis Plan), had undergone left atrial closure with the device from August 2020 to September 2022. There were no exclusion criteria. Ultimately, 2 years of follow-up is planned.

With more than 16,000 patients enrolled, the data on 14,363 patients in this initial 45-day analysis represents “the largest number of Watchman FLX patients evaluated to date,” Dr. Kapadia reported.
 

Device implantation success 97.5%

The Watchman FLX, which is delivered to the left atrial appendage by a transcatheter approach, was deployed successfully in 97.5% of all 16,048 patients enrolled in the registry. In the 398 cases without successful deployment, the anatomy was not conducive in nearly 70%. Other reasons included failure to meet device-release criteria and change in patient condition.

The outcomes of interest at 45 days were ischemic strokes, systemic emboli, device-related thrombi, device embolization, and bleeding. The primary endpoints at 2 years will be strokes and thrombotic events.

For stroke, the incidence within 45 days was 0.39%. About 25% of the strokes were hemorrhagic and the remainder were ischemic. There was 1 systemic embolism (0.01%), 5 device embolizations (0.03%), and 30 device-related thrombotic events (0.24%). Major bleeding occurred in 508 patients (3.55%).

For context, Dr. Kapadia compared these results to those observed in the PINNACLE FLX trial, which was a nonrandomized but prospective study of the Watchman FLX published about 1 year ago. In PINNACLE FLX, the enrollment was open to patients indicated for oral anticoagulation but who had an appropriate rationale for seeking a nonpharmacological alternative.

Taken from different studies, the outcomes at 45 days should not be construed as a direct comparison, but the similarity of the results can be considered reassuring, according to Dr. Kapadia.

For the composite safety endpoint of all-cause death, ischemic stroke, systemic embolism, or implantation-related events requiring intervention, the rates in SURPASS (0.4%) and PINNACLE FLX (0.5%) were nearly identical. Device leak rates (82.0% vs. 82.8%), stroke rates (0.4% vs. 0.7%), and all-cause death rates (0.9% vs. 0.5%) were also similar.

The similarity of the SURPASS and PINNACLE FLX data provides another level of reassurance.

“The SURPASS registry confirms the safety of the Watchman Flex in the real-world experience when the device is being used by many different operators in a large patient population,” Dr. Kapadia said in an interview.

In “appropriately selected patients,” the SURPASS data confirm that the Watchman FLX device “provides a safe and effective treatment option,” he added.

Relative to the PINNACLE FLX study, which enrolled 400 patients, it is noteworthy that the median age in SURPASS was older (76 vs. 73.8 years), a potential disadvantage in demonstrating comparable safety. The proportion of non-White patients was similar (6.7% vs. 6.3%). SURPASS had a higher proportion of women (40% vs. 35.5%).

Mitchel L. Zoler/MDedge News

The SURPASS data are credible, according to Vivek Y. Reddy, MD, director of cardiac arrhythmia services, Mount Sinai Health System, New York.

“While there are certainly limitations to registry data, I do feel pretty confident that these procedural complication and success rates [in SURPASS] do indeed reflect reality,” said Dr. Reddy, who was a coauthor of the PINNACLE FLX trial. In general, the SURPASS data “mirror most of our clinical experiences in routine clinical practice.”

With these registry data backing up multiple clinical studies, Dr. Reddy concluded, “I do believe that it is fair to say that Watchman-FLX implantation is a quite safe procedure.”

Dr. Kapadia reported no potential conflicts of interest. Dr. Reddy reported a financial relationship with Boston Scientific.

Although the Sentinel cerebral embolism protection (CEP) device may not significantly reduce the overall stroke rate in patients after they’ve had transcatheter aortic valve replacement (TAVR), the device may improve survival and reduce the severity of procedure-related stroke, a retrospective database study reported.

Investigators led by Samir R. Kapadia, MD, chair of cardiovascular medicine at the Cleveland Clinic, analyzed outcomes of 136,382 patients in the Nationwide Readmissions Database who had TAVR in 2018-2019. The dataset included 10,201 people who received the Sentinel CEP device during TAVR.

The proportion of patients who had a stroke after TAVR was similar in both groups – 1.85% (189) in the CEP group and 1.94% (1,447) in the CEP nonusers – but, as Dr. Kapadia pointed out, the stroke outcomes between the two groups were noticeably different.

“Interestingly enough, what we found was that the people with the CEPs who had a stroke had half the mortality, and they were going home at a significantly higher rate, than the people who had a stroke and didn’t have CEPs,” Dr. Kapadia said in an interview. A previous registry study of 276,316 TAVR patients reported the overall rate of post-TAVR stroke declined from 2.75% to 2.3% over an 8-year period. The CEP device, approved in December 2017, had been available in the last 2 years of that study.

In the current retrospective database study, CEP patients went home after their post-TAVR strokes at a rate of 28.2%, compared with 19.9% for those who didn’t have CEP (P = .011). The in-hospital death rates were 6.3% and 11.8% for the respective groups (P = .023), and the 30-day readmission rates were 15.9% and 16.8% (P = .91). “The readmission rate is similar, but if you survive you get admitted,” Dr. Kapadia reported in a research letter published in JACC: Cardiovascular Interventions.

CEP involves inserting a catheter in the right wrist during TAVR. The catheter deploys two filters, one in the left carotid artery, the other on the right carotid and radial arteries, to capture embolic debris. After the aortic valve is seated and the TAVR completed, the CEP filters are removed.

Potential effectiveness of filters

The study builds on work by Dr. Kapadia and colleagues reported in the PARTNER trial, which showed that CEP filters consistently captured embolized debris resulting in smaller brain lesions after TAVR than no filters. The hypothesis for the latest study, Dr. Kapadia said, “was that, even though the stroke rates may be very similar between the TAVR patients who had CEP and those who did not, the filter removed the large embolic particles, although there were small particles. In those cases, the consequence of stroke would be much less in the sense that you would have minor strokes, and you would either not die from the stroke or you would be able to walk home safely if you did have a stroke.”

In Dr. Kapadia’s experience, the filters capture up to 80% of embolic debris. The Cleveland Clinic used CEP in 96.5% of its TAVR cases in 2021, he said, adding that national rates are considerably lower because Medicare doesn’t reimburse for the procedure. An observational registry study reported that 13% of TAVR procedures used CEP by December 2019.

Dr. Kapadia said that the PROTECTED TAVR trial of the CEP device has completed data gathering and should report results later in 2022. The study randomized 3,000 patients to TAVR with or without CEP.

Dr. Kapadia noted that the findings require further study to validate them. “If it is all true, it will change the practice; it will make TAVR safer.”

David J. Cohen, MD, MSc, director of clinical and outcome research at the Cardiovascular Research Foundation in New York, called the study findings “provocative,” adding: “It makes points that we’ve seen in previous studies and certainly suggests there may be an important benefit of cerebral embolism protection that has not been well established to date.” Dr. Cohen is also director of academic affairs at St. Francis Hospital in Roslyn, N.Y.

The primary two findings of the study – lower risk of death and greater likelihood of discharge to home in CEP patients who had strokes after TAVR – “suggest that, while data on whether embolic protection actually prevents strokes is controversial and not at all definitive, these data suggest that perhaps one additional mechanism of benefit is that it’s making it much less severe when stroke occurs. That would obviously be of tremendous value.”

The findings are in line with other “suggestions that have not yet been explained,” Dr. Cohen said. “They may provide sort of a unifying explanation of why embolic protection may not prevent as many strokes as we thought but they may still be a very valuable adjunct.”

Boston Scientific distributes the Sentinel CEP device used in the study. Dr. Kapadia is the principal investigator of the PROTECTED TAVR trial, sponsored by Boston Scientific. Dr. Kapadia and study coauthors reported no other disclosures. Dr. Cohen is a consultant to Boston Scientific.

Although the Sentinel cerebral embolism protection (CEP) device may not significantly reduce the overall stroke rate in patients after they’ve had transcatheter aortic valve replacement (TAVR), the device may improve survival and reduce the severity of procedure-related stroke, a retrospective database study reported.

Investigators led by Samir R. Kapadia, MD, chair of cardiovascular medicine at the Cleveland Clinic, analyzed outcomes of 136,382 patients in the Nationwide Readmissions Database who had TAVR in 2018-2019. The dataset included 10,201 people who received the Sentinel CEP device during TAVR.

The proportion of patients who had a stroke after TAVR was similar in both groups – 1.85% (189) in the CEP group and 1.94% (1,447) in the CEP nonusers – but, as Dr. Kapadia pointed out, the stroke outcomes between the two groups were noticeably different.

“Interestingly enough, what we found was that the people with the CEPs who had a stroke had half the mortality, and they were going home at a significantly higher rate, than the people who had a stroke and didn’t have CEPs,” Dr. Kapadia said in an interview. A previous registry study of 276,316 TAVR patients reported the overall rate of post-TAVR stroke declined from 2.75% to 2.3% over an 8-year period. The CEP device, approved in December 2017, had been available in the last 2 years of that study.

In the current retrospective database study, CEP patients went home after their post-TAVR strokes at a rate of 28.2%, compared with 19.9% for those who didn’t have CEP (P = .011). The in-hospital death rates were 6.3% and 11.8% for the respective groups (P = .023), and the 30-day readmission rates were 15.9% and 16.8% (P = .91). “The readmission rate is similar, but if you survive you get admitted,” Dr. Kapadia reported in a research letter published in JACC: Cardiovascular Interventions.

CEP involves inserting a catheter in the right wrist during TAVR. The catheter deploys two filters, one in the left carotid artery, the other on the right carotid and radial arteries, to capture embolic debris. After the aortic valve is seated and the TAVR completed, the CEP filters are removed.

Potential effectiveness of filters

The study builds on work by Dr. Kapadia and colleagues reported in the PARTNER trial, which showed that CEP filters consistently captured embolized debris resulting in smaller brain lesions after TAVR than no filters. The hypothesis for the latest study, Dr. Kapadia said, “was that, even though the stroke rates may be very similar between the TAVR patients who had CEP and those who did not, the filter removed the large embolic particles, although there were small particles. In those cases, the consequence of stroke would be much less in the sense that you would have minor strokes, and you would either not die from the stroke or you would be able to walk home safely if you did have a stroke.”

In Dr. Kapadia’s experience, the filters capture up to 80% of embolic debris. The Cleveland Clinic used CEP in 96.5% of its TAVR cases in 2021, he said, adding that national rates are considerably lower because Medicare doesn’t reimburse for the procedure. An observational registry study reported that 13% of TAVR procedures used CEP by December 2019.

Dr. Kapadia said that the PROTECTED TAVR trial of the CEP device has completed data gathering and should report results later in 2022. The study randomized 3,000 patients to TAVR with or without CEP.

Dr. Kapadia noted that the findings require further study to validate them. “If it is all true, it will change the practice; it will make TAVR safer.”

David J. Cohen, MD, MSc, director of clinical and outcome research at the Cardiovascular Research Foundation in New York, called the study findings “provocative,” adding: “It makes points that we’ve seen in previous studies and certainly suggests there may be an important benefit of cerebral embolism protection that has not been well established to date.” Dr. Cohen is also director of academic affairs at St. Francis Hospital in Roslyn, N.Y.

The primary two findings of the study – lower risk of death and greater likelihood of discharge to home in CEP patients who had strokes after TAVR – “suggest that, while data on whether embolic protection actually prevents strokes is controversial and not at all definitive, these data suggest that perhaps one additional mechanism of benefit is that it’s making it much less severe when stroke occurs. That would obviously be of tremendous value.”

The findings are in line with other “suggestions that have not yet been explained,” Dr. Cohen said. “They may provide sort of a unifying explanation of why embolic protection may not prevent as many strokes as we thought but they may still be a very valuable adjunct.”

Boston Scientific distributes the Sentinel CEP device used in the study. Dr. Kapadia is the principal investigator of the PROTECTED TAVR trial, sponsored by Boston Scientific. Dr. Kapadia and study coauthors reported no other disclosures. Dr. Cohen is a consultant to Boston Scientific.

Although the Sentinel cerebral embolism protection (CEP) device may not significantly reduce the overall stroke rate in patients after they’ve had transcatheter aortic valve replacement (TAVR), the device may improve survival and reduce the severity of procedure-related stroke, a retrospective database study reported.

Investigators led by Samir R. Kapadia, MD, chair of cardiovascular medicine at the Cleveland Clinic, analyzed outcomes of 136,382 patients in the Nationwide Readmissions Database who had TAVR in 2018-2019. The dataset included 10,201 people who received the Sentinel CEP device during TAVR.

The proportion of patients who had a stroke after TAVR was similar in both groups – 1.85% (189) in the CEP group and 1.94% (1,447) in the CEP nonusers – but, as Dr. Kapadia pointed out, the stroke outcomes between the two groups were noticeably different.

“Interestingly enough, what we found was that the people with the CEPs who had a stroke had half the mortality, and they were going home at a significantly higher rate, than the people who had a stroke and didn’t have CEPs,” Dr. Kapadia said in an interview. A previous registry study of 276,316 TAVR patients reported the overall rate of post-TAVR stroke declined from 2.75% to 2.3% over an 8-year period. The CEP device, approved in December 2017, had been available in the last 2 years of that study.

In the current retrospective database study, CEP patients went home after their post-TAVR strokes at a rate of 28.2%, compared with 19.9% for those who didn’t have CEP (P = .011). The in-hospital death rates were 6.3% and 11.8% for the respective groups (P = .023), and the 30-day readmission rates were 15.9% and 16.8% (P = .91). “The readmission rate is similar, but if you survive you get admitted,” Dr. Kapadia reported in a research letter published in JACC: Cardiovascular Interventions.

CEP involves inserting a catheter in the right wrist during TAVR. The catheter deploys two filters, one in the left carotid artery, the other on the right carotid and radial arteries, to capture embolic debris. After the aortic valve is seated and the TAVR completed, the CEP filters are removed.

Potential effectiveness of filters

The study builds on work by Dr. Kapadia and colleagues reported in the PARTNER trial, which showed that CEP filters consistently captured embolized debris resulting in smaller brain lesions after TAVR than no filters. The hypothesis for the latest study, Dr. Kapadia said, “was that, even though the stroke rates may be very similar between the TAVR patients who had CEP and those who did not, the filter removed the large embolic particles, although there were small particles. In those cases, the consequence of stroke would be much less in the sense that you would have minor strokes, and you would either not die from the stroke or you would be able to walk home safely if you did have a stroke.”

In Dr. Kapadia’s experience, the filters capture up to 80% of embolic debris. The Cleveland Clinic used CEP in 96.5% of its TAVR cases in 2021, he said, adding that national rates are considerably lower because Medicare doesn’t reimburse for the procedure. An observational registry study reported that 13% of TAVR procedures used CEP by December 2019.

Dr. Kapadia said that the PROTECTED TAVR trial of the CEP device has completed data gathering and should report results later in 2022. The study randomized 3,000 patients to TAVR with or without CEP.

Dr. Kapadia noted that the findings require further study to validate them. “If it is all true, it will change the practice; it will make TAVR safer.”

David J. Cohen, MD, MSc, director of clinical and outcome research at the Cardiovascular Research Foundation in New York, called the study findings “provocative,” adding: “It makes points that we’ve seen in previous studies and certainly suggests there may be an important benefit of cerebral embolism protection that has not been well established to date.” Dr. Cohen is also director of academic affairs at St. Francis Hospital in Roslyn, N.Y.

The primary two findings of the study – lower risk of death and greater likelihood of discharge to home in CEP patients who had strokes after TAVR – “suggest that, while data on whether embolic protection actually prevents strokes is controversial and not at all definitive, these data suggest that perhaps one additional mechanism of benefit is that it’s making it much less severe when stroke occurs. That would obviously be of tremendous value.”

The findings are in line with other “suggestions that have not yet been explained,” Dr. Cohen said. “They may provide sort of a unifying explanation of why embolic protection may not prevent as many strokes as we thought but they may still be a very valuable adjunct.”

Boston Scientific distributes the Sentinel CEP device used in the study. Dr. Kapadia is the principal investigator of the PROTECTED TAVR trial, sponsored by Boston Scientific. Dr. Kapadia and study coauthors reported no other disclosures. Dr. Cohen is a consultant to Boston Scientific.

The chance that patients with severe aortic stenosis (AS) will receive aortic valve replacement (AVR) is worse than the flip of a coin, even a decade after the gamechanging transcatheter option became available, a new study suggests.

Of the study’s 6,150 patients with an indication or potential indication for AVR, 48% received the procedure at Massachusetts General Hospital and its partner institution Brigham and Women’s Hospital, both in Boston – both of which have active, high-volume transcatheter and surgical AVR (TAVR/SAVR) programs.

“Essentially, this is a best-case scenario. So, unfortunately, I think on the national level we are likely to see rates that are far worse than what we observed here,” senior author Sammy Elmariah, MD, PhD, Massachusetts General Hospital, told this news organization.

The volume of AVR increased more than 10-fold over the 18-year study period (2000 to 2017), driven by the exponential growth of TAVR, he noted. However, the graying of America led to an even greater increase in the number of patients with severe AS and an indication for AVR.

The study, led by Shawn X. Li, MD, MBA, of Mass General, was published in the March 8 issue of the Journal of the American College of Cardiology.

Previous research has provided equally compelling data on the undertreatment of AS, including a 2021 study using natural language processing (NLP) that found AVR use was just 35.6% within 1 year of diagnosis and varied wildly among managing cardiologists.

The present study used NLP tools to identify symptoms consistent with severe AS in the medical record coupled with echocardiographic data from 10,795 patients with severe AS (valve area <1 cm2). Patients were divided into four AS subtypes and then classified as having a class 1 indication (high-gradient AS with symptoms or reduced ejection fraction [EF]) or a potential class 2a indication (low-gradient AS with symptoms) for AVR.

Among patients with high-gradient AS and class 1 indication for AVR, 1 in 3 did not receive AVR over the study period, including 30% with a normal EF and 47% with a low EF.

In those with low-gradient AS, 67% with a normal EF and 62% with a low EF did not receive AVR. The low-gradient groups were significantly less likely to receive AVR both in the entire study period and in the more contemporary period from 2014 to 2017, despite the valvular heart disease guideline 2014 update indicating AVR was “reasonable” in patients with low-gradient AS – a 2a recommendation upgraded to class 1 in the most recent 2020 update.
 

Better survival

In patients with a class 1 or potential class 2a indication, AVR was associated with a significantly lower risk of mortality in all four AS subgroups:

• High gradient/normal EF: 3% vs. 15%; adjusted hazard ratio, 0.42
• High-gradient/low EF: 16% vs. 72%; aHR, 0.28
• Low-gradient/normal EF: 5% vs. 14%; aHR, 0.73
• Low-gradient/low EF: 11% vs. 34%; aHR, 0.48; P < .001 for all

“I think what we need to do is change the paradigm, such that patients with a valve area that is less than or equal to 1 [cm2] is severe aortic stenosis until proven otherwise, and that essentially establishes a premise by which we default to treat these patients unless we can prove that it is in fact moderate,” Dr. Elmariah said.

Unfortunately, the opposite is currently true today, he said, and the default is not to treat and put patients through surgery or an invasive TAVR procedure unless physicians can definitively prove that it is severe AS. But they’re not always correct and don’t always have the ability to truly differentiate moderate from severe disease.

“The question, therefore, is ‘What do we do with those patients?’” Dr. Elmariah asked. “I think if a patient has symptoms, then we are obligated to intervene, given the stark difference in mortality that one sees when these patients go undertreated.”
 

Sounding the alarm

Robert Bonow, MD, a professor of cardiology at Northwestern University in Chicago and a writing committee member for the 2014 guideline update, said the study is a “big wake-up call” and “the take-home message is that we are missing some patients who have treatable aortic stenosis.”

The sheer magnitude of the problem, however, can be difficult to fully ascertain from administrative data like this, he said. Notably, patients who did not receive AVR were significantly older, with 37% aged 81-90 years and 12% over age 90, and had a lower hematocrit and lower estimated glomerular filtration rate. But it’s not clear how many had cancer, end-stage renal disease, or severe lung disease, which could have factored into the decision to undergo AVR.

“What’s also an issue is that over 50% of patients had low gradient disease, which is very problematic and takes careful assessment in an individual patient,” said Dr. Bonow, who is also editor-in-chief of JAMA Cardiology. “That’s all being generated by a low valve area of less than 1 cm2 from echo reports, so that’s not necessarily a careful prospective echo assessment ... so some of the patients with low-gradient disease may not have true severe aortic stenosis.”

Dr. Elmariah agreed that echocardiogram reports are not always clear cut and pointed out that referral to a valve specialist was highly predictive of whether or not a patient underwent AVR, supporting the class 1 guideline recommendation.

He also noted that Mass General is launching the DETECT-AS trial to determine whether electronic physician notifications highlighting clinical practice guideline recommendations will improve AVR utilization over standard care in 940 patients with severe AS on echocardiogram, defined by a valve area less than 1 cm2.

Reached for comment, Catherine Otto, MD, director of the Heart Valve Clinic at the University of Washington, Seattle, and a fellow member of the 2014 guideline writing committee, said “this adds to the data [that] we’re undertreating severe aortic stenosis, and it continues to be surprising given the availability of transcatheter options.”

A version of this article first appeared on Medscape.com.

The chance that patients with severe aortic stenosis (AS) will receive aortic valve replacement (AVR) is worse than the flip of a coin, even a decade after the gamechanging transcatheter option became available, a new study suggests.

Of the study’s 6,150 patients with an indication or potential indication for AVR, 48% received the procedure at Massachusetts General Hospital and its partner institution Brigham and Women’s Hospital, both in Boston – both of which have active, high-volume transcatheter and surgical AVR (TAVR/SAVR) programs.

“Essentially, this is a best-case scenario. So, unfortunately, I think on the national level we are likely to see rates that are far worse than what we observed here,” senior author Sammy Elmariah, MD, PhD, Massachusetts General Hospital, told this news organization.

The volume of AVR increased more than 10-fold over the 18-year study period (2000 to 2017), driven by the exponential growth of TAVR, he noted. However, the graying of America led to an even greater increase in the number of patients with severe AS and an indication for AVR.

The study, led by Shawn X. Li, MD, MBA, of Mass General, was published in the March 8 issue of the Journal of the American College of Cardiology.

Previous research has provided equally compelling data on the undertreatment of AS, including a 2021 study using natural language processing (NLP) that found AVR use was just 35.6% within 1 year of diagnosis and varied wildly among managing cardiologists.

The present study used NLP tools to identify symptoms consistent with severe AS in the medical record coupled with echocardiographic data from 10,795 patients with severe AS (valve area <1 cm2). Patients were divided into four AS subtypes and then classified as having a class 1 indication (high-gradient AS with symptoms or reduced ejection fraction [EF]) or a potential class 2a indication (low-gradient AS with symptoms) for AVR.

Among patients with high-gradient AS and class 1 indication for AVR, 1 in 3 did not receive AVR over the study period, including 30% with a normal EF and 47% with a low EF.

In those with low-gradient AS, 67% with a normal EF and 62% with a low EF did not receive AVR. The low-gradient groups were significantly less likely to receive AVR both in the entire study period and in the more contemporary period from 2014 to 2017, despite the valvular heart disease guideline 2014 update indicating AVR was “reasonable” in patients with low-gradient AS – a 2a recommendation upgraded to class 1 in the most recent 2020 update.
 

Better survival

In patients with a class 1 or potential class 2a indication, AVR was associated with a significantly lower risk of mortality in all four AS subgroups:

• High gradient/normal EF: 3% vs. 15%; adjusted hazard ratio, 0.42
• High-gradient/low EF: 16% vs. 72%; aHR, 0.28
• Low-gradient/normal EF: 5% vs. 14%; aHR, 0.73
• Low-gradient/low EF: 11% vs. 34%; aHR, 0.48; P < .001 for all

“I think what we need to do is change the paradigm, such that patients with a valve area that is less than or equal to 1 [cm2] is severe aortic stenosis until proven otherwise, and that essentially establishes a premise by which we default to treat these patients unless we can prove that it is in fact moderate,” Dr. Elmariah said.

Unfortunately, the opposite is currently true today, he said, and the default is not to treat and put patients through surgery or an invasive TAVR procedure unless physicians can definitively prove that it is severe AS. But they’re not always correct and don’t always have the ability to truly differentiate moderate from severe disease.

“The question, therefore, is ‘What do we do with those patients?’” Dr. Elmariah asked. “I think if a patient has symptoms, then we are obligated to intervene, given the stark difference in mortality that one sees when these patients go undertreated.”
 

Sounding the alarm

Robert Bonow, MD, a professor of cardiology at Northwestern University in Chicago and a writing committee member for the 2014 guideline update, said the study is a “big wake-up call” and “the take-home message is that we are missing some patients who have treatable aortic stenosis.”

The sheer magnitude of the problem, however, can be difficult to fully ascertain from administrative data like this, he said. Notably, patients who did not receive AVR were significantly older, with 37% aged 81-90 years and 12% over age 90, and had a lower hematocrit and lower estimated glomerular filtration rate. But it’s not clear how many had cancer, end-stage renal disease, or severe lung disease, which could have factored into the decision to undergo AVR.

“What’s also an issue is that over 50% of patients had low gradient disease, which is very problematic and takes careful assessment in an individual patient,” said Dr. Bonow, who is also editor-in-chief of JAMA Cardiology. “That’s all being generated by a low valve area of less than 1 cm2 from echo reports, so that’s not necessarily a careful prospective echo assessment ... so some of the patients with low-gradient disease may not have true severe aortic stenosis.”

Dr. Elmariah agreed that echocardiogram reports are not always clear cut and pointed out that referral to a valve specialist was highly predictive of whether or not a patient underwent AVR, supporting the class 1 guideline recommendation.

He also noted that Mass General is launching the DETECT-AS trial to determine whether electronic physician notifications highlighting clinical practice guideline recommendations will improve AVR utilization over standard care in 940 patients with severe AS on echocardiogram, defined by a valve area less than 1 cm2.

Reached for comment, Catherine Otto, MD, director of the Heart Valve Clinic at the University of Washington, Seattle, and a fellow member of the 2014 guideline writing committee, said “this adds to the data [that] we’re undertreating severe aortic stenosis, and it continues to be surprising given the availability of transcatheter options.”

A version of this article first appeared on Medscape.com.

The chance that patients with severe aortic stenosis (AS) will receive aortic valve replacement (AVR) is worse than the flip of a coin, even a decade after the gamechanging transcatheter option became available, a new study suggests.

Of the study’s 6,150 patients with an indication or potential indication for AVR, 48% received the procedure at Massachusetts General Hospital and its partner institution Brigham and Women’s Hospital, both in Boston – both of which have active, high-volume transcatheter and surgical AVR (TAVR/SAVR) programs.

“Essentially, this is a best-case scenario. So, unfortunately, I think on the national level we are likely to see rates that are far worse than what we observed here,” senior author Sammy Elmariah, MD, PhD, Massachusetts General Hospital, told this news organization.

The volume of AVR increased more than 10-fold over the 18-year study period (2000 to 2017), driven by the exponential growth of TAVR, he noted. However, the graying of America led to an even greater increase in the number of patients with severe AS and an indication for AVR.

The study, led by Shawn X. Li, MD, MBA, of Mass General, was published in the March 8 issue of the Journal of the American College of Cardiology.

Previous research has provided equally compelling data on the undertreatment of AS, including a 2021 study using natural language processing (NLP) that found AVR use was just 35.6% within 1 year of diagnosis and varied wildly among managing cardiologists.

The present study used NLP tools to identify symptoms consistent with severe AS in the medical record coupled with echocardiographic data from 10,795 patients with severe AS (valve area <1 cm2). Patients were divided into four AS subtypes and then classified as having a class 1 indication (high-gradient AS with symptoms or reduced ejection fraction [EF]) or a potential class 2a indication (low-gradient AS with symptoms) for AVR.

Among patients with high-gradient AS and class 1 indication for AVR, 1 in 3 did not receive AVR over the study period, including 30% with a normal EF and 47% with a low EF.

In those with low-gradient AS, 67% with a normal EF and 62% with a low EF did not receive AVR. The low-gradient groups were significantly less likely to receive AVR both in the entire study period and in the more contemporary period from 2014 to 2017, despite the valvular heart disease guideline 2014 update indicating AVR was “reasonable” in patients with low-gradient AS – a 2a recommendation upgraded to class 1 in the most recent 2020 update.
 

Better survival

In patients with a class 1 or potential class 2a indication, AVR was associated with a significantly lower risk of mortality in all four AS subgroups:

• High gradient/normal EF: 3% vs. 15%; adjusted hazard ratio, 0.42
• High-gradient/low EF: 16% vs. 72%; aHR, 0.28
• Low-gradient/normal EF: 5% vs. 14%; aHR, 0.73
• Low-gradient/low EF: 11% vs. 34%; aHR, 0.48; P < .001 for all

“I think what we need to do is change the paradigm, such that patients with a valve area that is less than or equal to 1 [cm2] is severe aortic stenosis until proven otherwise, and that essentially establishes a premise by which we default to treat these patients unless we can prove that it is in fact moderate,” Dr. Elmariah said.

Unfortunately, the opposite is currently true today, he said, and the default is not to treat and put patients through surgery or an invasive TAVR procedure unless physicians can definitively prove that it is severe AS. But they’re not always correct and don’t always have the ability to truly differentiate moderate from severe disease.

“The question, therefore, is ‘What do we do with those patients?’” Dr. Elmariah asked. “I think if a patient has symptoms, then we are obligated to intervene, given the stark difference in mortality that one sees when these patients go undertreated.”
 

Sounding the alarm

Robert Bonow, MD, a professor of cardiology at Northwestern University in Chicago and a writing committee member for the 2014 guideline update, said the study is a “big wake-up call” and “the take-home message is that we are missing some patients who have treatable aortic stenosis.”

The sheer magnitude of the problem, however, can be difficult to fully ascertain from administrative data like this, he said. Notably, patients who did not receive AVR were significantly older, with 37% aged 81-90 years and 12% over age 90, and had a lower hematocrit and lower estimated glomerular filtration rate. But it’s not clear how many had cancer, end-stage renal disease, or severe lung disease, which could have factored into the decision to undergo AVR.

“What’s also an issue is that over 50% of patients had low gradient disease, which is very problematic and takes careful assessment in an individual patient,” said Dr. Bonow, who is also editor-in-chief of JAMA Cardiology. “That’s all being generated by a low valve area of less than 1 cm2 from echo reports, so that’s not necessarily a careful prospective echo assessment ... so some of the patients with low-gradient disease may not have true severe aortic stenosis.”

Dr. Elmariah agreed that echocardiogram reports are not always clear cut and pointed out that referral to a valve specialist was highly predictive of whether or not a patient underwent AVR, supporting the class 1 guideline recommendation.

He also noted that Mass General is launching the DETECT-AS trial to determine whether electronic physician notifications highlighting clinical practice guideline recommendations will improve AVR utilization over standard care in 940 patients with severe AS on echocardiogram, defined by a valve area less than 1 cm2.

Reached for comment, Catherine Otto, MD, director of the Heart Valve Clinic at the University of Washington, Seattle, and a fellow member of the 2014 guideline writing committee, said “this adds to the data [that] we’re undertreating severe aortic stenosis, and it continues to be surprising given the availability of transcatheter options.”

A version of this article first appeared on Medscape.com.

Increasingly active patterns of physical activity were linked with reduced rates of overall mortality and cardiovascular disease (CVD), but early rather than later in late life, in a 20-year follow-up cohort study.

In this population of people older than 65 years, researchers found that physical activity overall was associated with lower rates of incident CVD, particularly among men, and the association was strongest in people 70 to 75 years of age, rather than in older age groups.

They also looked at “trajectories,” or changes in activity over time, and found that a stable-high trajectory of activity was associated with a significantly lower risk for cardiovascular outcomes in men than in those with a stable-low trajectory. For women, more physical activity was consistently associated with lower CVD outcomes, although not statistically significantly so, except for overall mortality, which did reach significance.

Notably, the greatest reduction in cardiovascular risk was reported in people who did more than 20 minutes of physical exercise each day, and it was more pronounced in those 70 years of age.

Physical activity was also associated with a lower incidence of heart failure and coronary heart disease in older people, again especially early on in late life, reported Claudio Barbiellini Amidei, MD, University of Padua, Italy, and colleagues.

The data suggest that physical activity is more effective in preventing CVD onset when implemented early rather than later in life, noted Dr. Amidei in an email.

“The findings of our study are suggestive of a protective effect of physical activity in late-life on cardiovascular health. WHO recommendations for adults and older adults are to practice at least 20 minutes of moderate to vigorous physical activity per day. I believe this is a realistic target, and policy makers should raise awareness on the importance of achieving this goal at all ages, including in late-life,” Dr. Amidei said.

The study was published online Feb. 14 in Heart.

Previous research has demonstrated that the most benefit of high physical activity, compared with low, begins at about 60 years of age, and that is because younger people are at much lower risk, noted Carl “Chip” Lavie MD, FACC, medical director of cardiac rehabilitation and prevention, Ochsner Clinical School–The University of Queensland School of Medicine, New Orleans, who was not involved in the study.

“At quite old ages, for example over age 80, resistance exercise or weight training and balance training may be even more important than aerobic training,” he added.

Activity ‘trajectories’

The benefits of physical activity on cardiovascular risk are well established, the researchers note. Less clear is the role that trajectories of activity over time play, although research to date suggests a reduction in risk with increasing activity from mid-life to early old age, they write.

For the current analysis, the researchers assessed 3,099 Italian participants. Mean age was about 75 years, and baseline data were collected from 1995 to 1997.

Follow-up visits were conducted after 4 years and again after 7 years. Using hospital medical records and mortality data, the researchers were able to collect surveillance data through 2018. Hospital records, surveys, and clinical assessments helped them identify incident and prevalent cardiovascular diseases, such as stroke, coronary heart disease, and heart failure.

Participants’ physical activity patterns were classified as stable-high, low-increasing, high-decreasing, and stable-low. Exposure was evaluated at 70, 75, 80, and 85 years of age.

“In our analyses, we focused on moderate to vigorous physical activity, and these include a broad range of exercises, such as walking very briskly, playing tennis, [and] jogging, but comprise also other activities, such as gardening or doing household chores,” said Dr. Amidei.

Patterns of stable-low physical activity were linked to a significantly greater risk for cardiovascular outcomes in men than patterns of stable-high physical activity (hazard ratio, 0.48; 95% confidence interval, 0.27-0.86; P for trend = .002).

No significant relation was found between physical activity and stroke, the researchers note.

“The benefits of physical activity seem to lessen above the age of 75 years and seem more important in men,” noted Dr. Lavie. “This may be partly due to the higher risk of CVD in men. Women typically lag 13 to 15 years behind men for CVD but start catching up in older years.”

Limitations of the study include lack of information regarding physical activity during mid-life, the limited number of stroke events, the relatively few participants older than 85 years, and potential recall bias, the researchers note.

Another limitation was that the physical activity data were based on patient surveys collected 3 years apart and did not involve the use of an accelerometer, the researchers add.

“Future observational studies are required to confirm our findings and pathophysiological studies are warranted to examine the underlying biological mechanisms. Physical activity is likely to be beneficial at any age, but to summarize our findings, we could say that when it comes to being physically active, the sooner the better,” concluded Dr. Amidei.

Dr. Amidei reports no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Increasingly active patterns of physical activity were linked with reduced rates of overall mortality and cardiovascular disease (CVD), but early rather than later in late life, in a 20-year follow-up cohort study.

In this population of people older than 65 years, researchers found that physical activity overall was associated with lower rates of incident CVD, particularly among men, and the association was strongest in people 70 to 75 years of age, rather than in older age groups.

They also looked at “trajectories,” or changes in activity over time, and found that a stable-high trajectory of activity was associated with a significantly lower risk for cardiovascular outcomes in men than in those with a stable-low trajectory. For women, more physical activity was consistently associated with lower CVD outcomes, although not statistically significantly so, except for overall mortality, which did reach significance.

Notably, the greatest reduction in cardiovascular risk was reported in people who did more than 20 minutes of physical exercise each day, and it was more pronounced in those 70 years of age.

Physical activity was also associated with a lower incidence of heart failure and coronary heart disease in older people, again especially early on in late life, reported Claudio Barbiellini Amidei, MD, University of Padua, Italy, and colleagues.

The data suggest that physical activity is more effective in preventing CVD onset when implemented early rather than later in life, noted Dr. Amidei in an email.

“The findings of our study are suggestive of a protective effect of physical activity in late-life on cardiovascular health. WHO recommendations for adults and older adults are to practice at least 20 minutes of moderate to vigorous physical activity per day. I believe this is a realistic target, and policy makers should raise awareness on the importance of achieving this goal at all ages, including in late-life,” Dr. Amidei said.

The study was published online Feb. 14 in Heart.

Previous research has demonstrated that the most benefit of high physical activity, compared with low, begins at about 60 years of age, and that is because younger people are at much lower risk, noted Carl “Chip” Lavie MD, FACC, medical director of cardiac rehabilitation and prevention, Ochsner Clinical School–The University of Queensland School of Medicine, New Orleans, who was not involved in the study.

“At quite old ages, for example over age 80, resistance exercise or weight training and balance training may be even more important than aerobic training,” he added.

Activity ‘trajectories’

The benefits of physical activity on cardiovascular risk are well established, the researchers note. Less clear is the role that trajectories of activity over time play, although research to date suggests a reduction in risk with increasing activity from mid-life to early old age, they write.

For the current analysis, the researchers assessed 3,099 Italian participants. Mean age was about 75 years, and baseline data were collected from 1995 to 1997.

Follow-up visits were conducted after 4 years and again after 7 years. Using hospital medical records and mortality data, the researchers were able to collect surveillance data through 2018. Hospital records, surveys, and clinical assessments helped them identify incident and prevalent cardiovascular diseases, such as stroke, coronary heart disease, and heart failure.

Participants’ physical activity patterns were classified as stable-high, low-increasing, high-decreasing, and stable-low. Exposure was evaluated at 70, 75, 80, and 85 years of age.

“In our analyses, we focused on moderate to vigorous physical activity, and these include a broad range of exercises, such as walking very briskly, playing tennis, [and] jogging, but comprise also other activities, such as gardening or doing household chores,” said Dr. Amidei.

Patterns of stable-low physical activity were linked to a significantly greater risk for cardiovascular outcomes in men than patterns of stable-high physical activity (hazard ratio, 0.48; 95% confidence interval, 0.27-0.86; P for trend = .002).

No significant relation was found between physical activity and stroke, the researchers note.

“The benefits of physical activity seem to lessen above the age of 75 years and seem more important in men,” noted Dr. Lavie. “This may be partly due to the higher risk of CVD in men. Women typically lag 13 to 15 years behind men for CVD but start catching up in older years.”

Limitations of the study include lack of information regarding physical activity during mid-life, the limited number of stroke events, the relatively few participants older than 85 years, and potential recall bias, the researchers note.

Another limitation was that the physical activity data were based on patient surveys collected 3 years apart and did not involve the use of an accelerometer, the researchers add.

“Future observational studies are required to confirm our findings and pathophysiological studies are warranted to examine the underlying biological mechanisms. Physical activity is likely to be beneficial at any age, but to summarize our findings, we could say that when it comes to being physically active, the sooner the better,” concluded Dr. Amidei.

Dr. Amidei reports no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Increasingly active patterns of physical activity were linked with reduced rates of overall mortality and cardiovascular disease (CVD), but early rather than later in late life, in a 20-year follow-up cohort study.

In this population of people older than 65 years, researchers found that physical activity overall was associated with lower rates of incident CVD, particularly among men, and the association was strongest in people 70 to 75 years of age, rather than in older age groups.

They also looked at “trajectories,” or changes in activity over time, and found that a stable-high trajectory of activity was associated with a significantly lower risk for cardiovascular outcomes in men than in those with a stable-low trajectory. For women, more physical activity was consistently associated with lower CVD outcomes, although not statistically significantly so, except for overall mortality, which did reach significance.

Notably, the greatest reduction in cardiovascular risk was reported in people who did more than 20 minutes of physical exercise each day, and it was more pronounced in those 70 years of age.

Physical activity was also associated with a lower incidence of heart failure and coronary heart disease in older people, again especially early on in late life, reported Claudio Barbiellini Amidei, MD, University of Padua, Italy, and colleagues.

The data suggest that physical activity is more effective in preventing CVD onset when implemented early rather than later in life, noted Dr. Amidei in an email.

“The findings of our study are suggestive of a protective effect of physical activity in late-life on cardiovascular health. WHO recommendations for adults and older adults are to practice at least 20 minutes of moderate to vigorous physical activity per day. I believe this is a realistic target, and policy makers should raise awareness on the importance of achieving this goal at all ages, including in late-life,” Dr. Amidei said.

The study was published online Feb. 14 in Heart.

Previous research has demonstrated that the most benefit of high physical activity, compared with low, begins at about 60 years of age, and that is because younger people are at much lower risk, noted Carl “Chip” Lavie MD, FACC, medical director of cardiac rehabilitation and prevention, Ochsner Clinical School–The University of Queensland School of Medicine, New Orleans, who was not involved in the study.

“At quite old ages, for example over age 80, resistance exercise or weight training and balance training may be even more important than aerobic training,” he added.

Activity ‘trajectories’

The benefits of physical activity on cardiovascular risk are well established, the researchers note. Less clear is the role that trajectories of activity over time play, although research to date suggests a reduction in risk with increasing activity from mid-life to early old age, they write.

For the current analysis, the researchers assessed 3,099 Italian participants. Mean age was about 75 years, and baseline data were collected from 1995 to 1997.

Follow-up visits were conducted after 4 years and again after 7 years. Using hospital medical records and mortality data, the researchers were able to collect surveillance data through 2018. Hospital records, surveys, and clinical assessments helped them identify incident and prevalent cardiovascular diseases, such as stroke, coronary heart disease, and heart failure.

Participants’ physical activity patterns were classified as stable-high, low-increasing, high-decreasing, and stable-low. Exposure was evaluated at 70, 75, 80, and 85 years of age.

“In our analyses, we focused on moderate to vigorous physical activity, and these include a broad range of exercises, such as walking very briskly, playing tennis, [and] jogging, but comprise also other activities, such as gardening or doing household chores,” said Dr. Amidei.

Patterns of stable-low physical activity were linked to a significantly greater risk for cardiovascular outcomes in men than patterns of stable-high physical activity (hazard ratio, 0.48; 95% confidence interval, 0.27-0.86; P for trend = .002).

No significant relation was found between physical activity and stroke, the researchers note.

“The benefits of physical activity seem to lessen above the age of 75 years and seem more important in men,” noted Dr. Lavie. “This may be partly due to the higher risk of CVD in men. Women typically lag 13 to 15 years behind men for CVD but start catching up in older years.”

Limitations of the study include lack of information regarding physical activity during mid-life, the limited number of stroke events, the relatively few participants older than 85 years, and potential recall bias, the researchers note.

Another limitation was that the physical activity data were based on patient surveys collected 3 years apart and did not involve the use of an accelerometer, the researchers add.

“Future observational studies are required to confirm our findings and pathophysiological studies are warranted to examine the underlying biological mechanisms. Physical activity is likely to be beneficial at any age, but to summarize our findings, we could say that when it comes to being physically active, the sooner the better,” concluded Dr. Amidei.

Dr. Amidei reports no relevant financial relationships.

A version of this article first appeared on Medscape.com.

New signals of a potential additive benefit from the nonsteroidal mineralocorticoid antagonist finerenone (Kerendia) and a sodium-glucose transporter 2 inhibitor in patients with type 2 diabetes and chronic kidney disease (CKD) emerged in a follow-up report from the FIDELITY analysis, which combined data from more than 13,000 patients who received finerenone in either of the two pivotal trials with the agent.

The analysis showed that the 877 patients enrolled in either the FIDELIO DKD or FIGARO DKD trials taking an SGLT2 inhibitor at baseline had a 37% relative reduction in their urinary albumin-to-creatinine ratio (UACR), compared with placebo-treated patients after a median of 3 years on treatment.

Among the remaining 12,149 patients who did not receive an SGLT2 inhibitor, finerenone cut the average UACR by 32%, compared with placebo, said Peter Rossing, DMSc, MD, who presented the findings on Feb. 27 at the World Congress of Nephrology 2022 in Kuala Lumpur, Malaysia.

Primary endpoint results for FIDELIO-DKD and FIGARO-DKD also suggest similar additive effects of finerenone plus an SGLT2 inhibitor.

Results of the composite renal endpoint in each study – progression to kidney failure, renal death, or at least a 57% decline in estimated glomerular filtration rate (eGFR) from baseline – showed a 58% relative risk reduction in patients who received agents from both drug classes and a 20% relative risk reduction in those who only received finerenone, a between-group difference that was not significant.

For the composite cardiovascular event endpoint – cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure – the rate fell by 37%, compared with placebo, in patients who also received an SGLT2 inhibitor, and by 13%, compared with placebo, in those who received finerenone but no SGLT2 inhibitor, also a difference that was not significant.

‘A lot of interest in finerenone’ in U.S.

“The benefits of finerenone on cardiovascular and kidney outcomes were consistent, irrespective of SGLT2 inhibitor use at baseline,” concluded Dr. Rossing, professor and head of research at the Steno Diabetes Center in Copenhagen.

The new findings are a “suggestion that the two classes might be additive [in their effects], but more data are needed,” Dr. Rossing said during his presentation.

But he cautioned that in both pivotal trials randomization did not consider SGLT2 inhibitor use. All patients in the two trials were already receiving a renin-angiotensin system (RAS) inhibitor as background treatment, either an ACE inhibitor or angiotensin-receptor blocker.

The consequence of treatment with finerenone combined with an SGLT2 inhibitor is of growing importance because “an SGLT2 inhibitor is now recommended in most guidelines” for the type of patients enrolled in the two finerenone trials, explained Dr. Rossing.

He also noted that the first guideline to recommend routine use of finerenone in indicated patients appeared recently in the annual update to Standards of Medical Care in Diabetes – 2022 published by the American Diabetes Association.

The 2022 Standards states: “In patients with CKD who are at increased risk for cardiovascular events or CKD progression or are unable to use an SGLT2 inhibitor, a nonsteroidal mineralocorticoid receptor antagonist (finerenone) is recommended to reduce CKD progression and cardiovascular events.”

Results from FIDELIO-DKD, reported in the New England Journal of Medicine in 2020, and the main study, FIGARO-DKD, published in the same journal in 2021, led the Food and Drug Administration to approve finerenone in July 2021 to slow the progression of renal disease in patients with type 2 diabetes and CKD.

“My impression is that in the United States there is a lot of interest in finerenone,” Dr. Rossing said during the discussion following his presentation.

Finerenone has also been recently approved in the European Union.
 

‘Consistent’ benefits irrespective of SGLT2 inhibitors

“The cardiovascular and kidney benefits of finerenone were consistent irrespective of SGLT2 inhibitor use. This is definitely interesting and warrants a randomized controlled trial” to examine the relationship in a more rigorous way, commented Tejas Desai, MD, a nephrologist with the Department of Veterans Affairs, Charlotte, N.C.

That study, CONFIDENCE, is on its way, Dr. Rossing said during his talk. The randomized phase 2 trial has a planned enrollment of 800 patients with type 2 diabetes and CKD and three treatment groups: finerenone plus placebo, the SGLT2 inhibitor empagliflozin (Jardiance) plus placebo, or finerenone plus empagliflozin. The study will launch later in 2022 and has a planned completion date of late 2023.

“SGLT2 inhibitors, compared with finerenone, is where all of this is headed. We need a large trial that adjudicates the best medication to use with a RAS inhibitor,” Dr. Desai said in an interview.

The new analyses from the combined FIDELITY study expand on a previous report presented at the 2021 annual congress of the European Society of Cardiology and published in the European Heart Journal.
 

‘Impressive’ effect on cardiovascular events

The main findings from FIDELITY presented in those earlier reports, in 13,026 patients, showed there was a significant 14% relative reduction in the composite cardiovascular endpoint with finerenone, compared with placebo, during a median 3 years of follow-up.

The same report documented, in the total combined cohort, a significant 23% relative reduction in the composite renal endpoint in those taking finerenone compared with placebo.

“Reducing the risk of cardiovascular endpoints by a relative 14% is impressive,” and the time course showed a “relatively quick onset of action,” Dr. Desai noted.

He also characterized the enrolled patients, which included many with stage 3 or 4 CKD, as “not the sickest population of patients with CKD,” but rather “relatively healthier patients with CKD.”

Dr. Desai also downplayed the importance of the observed reduction in UACR associated with finerenone in FIDELITY.

“UACR is a surrogate marker. Results from many studies have shown improvements in UACR only to not show protection against falls in eGFR rate,” Dr. Desai said.

He was also reassured by the low incidence of hyperkalemia that led to discontinuation, which occurred in 1.7% of patients taking finerenone and in 0.6% of those taking placebo.

The types of patients enrolled in FIDELIO-DKD and FIGARO-DKD, who did not have eGFR rates below 25 mL/min per 1.73 m², are not particularly susceptible to this adverse effect, he said, noting, “I’m not overly concerned with hyperkalemia in this CKD population.

“I’m more concerned about [hyperkalemia in] patients with CKD and an eGFR of less than 25 mL/min per 1.73 m², but this was less than 1% of the enrolled population,” Dr. Desai observed.

FIDELIO-DKD, FIGARO-DKD, and FIDELITY were sponsored by Bayer, which markets finerenone (Kerendia). Dr. Rossing reported being a consultant for Bayer and other drug companies, and receiving research funding from AstraZeneca and Novo Nordisk. Dr. Desai reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

New signals of a potential additive benefit from the nonsteroidal mineralocorticoid antagonist finerenone (Kerendia) and a sodium-glucose transporter 2 inhibitor in patients with type 2 diabetes and chronic kidney disease (CKD) emerged in a follow-up report from the FIDELITY analysis, which combined data from more than 13,000 patients who received finerenone in either of the two pivotal trials with the agent.

The analysis showed that the 877 patients enrolled in either the FIDELIO DKD or FIGARO DKD trials taking an SGLT2 inhibitor at baseline had a 37% relative reduction in their urinary albumin-to-creatinine ratio (UACR), compared with placebo-treated patients after a median of 3 years on treatment.

Among the remaining 12,149 patients who did not receive an SGLT2 inhibitor, finerenone cut the average UACR by 32%, compared with placebo, said Peter Rossing, DMSc, MD, who presented the findings on Feb. 27 at the World Congress of Nephrology 2022 in Kuala Lumpur, Malaysia.

Primary endpoint results for FIDELIO-DKD and FIGARO-DKD also suggest similar additive effects of finerenone plus an SGLT2 inhibitor.

Results of the composite renal endpoint in each study – progression to kidney failure, renal death, or at least a 57% decline in estimated glomerular filtration rate (eGFR) from baseline – showed a 58% relative risk reduction in patients who received agents from both drug classes and a 20% relative risk reduction in those who only received finerenone, a between-group difference that was not significant.

For the composite cardiovascular event endpoint – cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure – the rate fell by 37%, compared with placebo, in patients who also received an SGLT2 inhibitor, and by 13%, compared with placebo, in those who received finerenone but no SGLT2 inhibitor, also a difference that was not significant.

‘A lot of interest in finerenone’ in U.S.

“The benefits of finerenone on cardiovascular and kidney outcomes were consistent, irrespective of SGLT2 inhibitor use at baseline,” concluded Dr. Rossing, professor and head of research at the Steno Diabetes Center in Copenhagen.

The new findings are a “suggestion that the two classes might be additive [in their effects], but more data are needed,” Dr. Rossing said during his presentation.

But he cautioned that in both pivotal trials randomization did not consider SGLT2 inhibitor use. All patients in the two trials were already receiving a renin-angiotensin system (RAS) inhibitor as background treatment, either an ACE inhibitor or angiotensin-receptor blocker.

The consequence of treatment with finerenone combined with an SGLT2 inhibitor is of growing importance because “an SGLT2 inhibitor is now recommended in most guidelines” for the type of patients enrolled in the two finerenone trials, explained Dr. Rossing.

He also noted that the first guideline to recommend routine use of finerenone in indicated patients appeared recently in the annual update to Standards of Medical Care in Diabetes – 2022 published by the American Diabetes Association.

The 2022 Standards states: “In patients with CKD who are at increased risk for cardiovascular events or CKD progression or are unable to use an SGLT2 inhibitor, a nonsteroidal mineralocorticoid receptor antagonist (finerenone) is recommended to reduce CKD progression and cardiovascular events.”

Results from FIDELIO-DKD, reported in the New England Journal of Medicine in 2020, and the main study, FIGARO-DKD, published in the same journal in 2021, led the Food and Drug Administration to approve finerenone in July 2021 to slow the progression of renal disease in patients with type 2 diabetes and CKD.

“My impression is that in the United States there is a lot of interest in finerenone,” Dr. Rossing said during the discussion following his presentation.

Finerenone has also been recently approved in the European Union.
 

‘Consistent’ benefits irrespective of SGLT2 inhibitors

“The cardiovascular and kidney benefits of finerenone were consistent irrespective of SGLT2 inhibitor use. This is definitely interesting and warrants a randomized controlled trial” to examine the relationship in a more rigorous way, commented Tejas Desai, MD, a nephrologist with the Department of Veterans Affairs, Charlotte, N.C.

That study, CONFIDENCE, is on its way, Dr. Rossing said during his talk. The randomized phase 2 trial has a planned enrollment of 800 patients with type 2 diabetes and CKD and three treatment groups: finerenone plus placebo, the SGLT2 inhibitor empagliflozin (Jardiance) plus placebo, or finerenone plus empagliflozin. The study will launch later in 2022 and has a planned completion date of late 2023.

“SGLT2 inhibitors, compared with finerenone, is where all of this is headed. We need a large trial that adjudicates the best medication to use with a RAS inhibitor,” Dr. Desai said in an interview.

The new analyses from the combined FIDELITY study expand on a previous report presented at the 2021 annual congress of the European Society of Cardiology and published in the European Heart Journal.
 

‘Impressive’ effect on cardiovascular events

The main findings from FIDELITY presented in those earlier reports, in 13,026 patients, showed there was a significant 14% relative reduction in the composite cardiovascular endpoint with finerenone, compared with placebo, during a median 3 years of follow-up.

The same report documented, in the total combined cohort, a significant 23% relative reduction in the composite renal endpoint in those taking finerenone compared with placebo.

“Reducing the risk of cardiovascular endpoints by a relative 14% is impressive,” and the time course showed a “relatively quick onset of action,” Dr. Desai noted.

He also characterized the enrolled patients, which included many with stage 3 or 4 CKD, as “not the sickest population of patients with CKD,” but rather “relatively healthier patients with CKD.”

Dr. Desai also downplayed the importance of the observed reduction in UACR associated with finerenone in FIDELITY.

“UACR is a surrogate marker. Results from many studies have shown improvements in UACR only to not show protection against falls in eGFR rate,” Dr. Desai said.

He was also reassured by the low incidence of hyperkalemia that led to discontinuation, which occurred in 1.7% of patients taking finerenone and in 0.6% of those taking placebo.

The types of patients enrolled in FIDELIO-DKD and FIGARO-DKD, who did not have eGFR rates below 25 mL/min per 1.73 m², are not particularly susceptible to this adverse effect, he said, noting, “I’m not overly concerned with hyperkalemia in this CKD population.

“I’m more concerned about [hyperkalemia in] patients with CKD and an eGFR of less than 25 mL/min per 1.73 m², but this was less than 1% of the enrolled population,” Dr. Desai observed.

FIDELIO-DKD, FIGARO-DKD, and FIDELITY were sponsored by Bayer, which markets finerenone (Kerendia). Dr. Rossing reported being a consultant for Bayer and other drug companies, and receiving research funding from AstraZeneca and Novo Nordisk. Dr. Desai reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

New signals of a potential additive benefit from the nonsteroidal mineralocorticoid antagonist finerenone (Kerendia) and a sodium-glucose transporter 2 inhibitor in patients with type 2 diabetes and chronic kidney disease (CKD) emerged in a follow-up report from the FIDELITY analysis, which combined data from more than 13,000 patients who received finerenone in either of the two pivotal trials with the agent.

The analysis showed that the 877 patients enrolled in either the FIDELIO DKD or FIGARO DKD trials taking an SGLT2 inhibitor at baseline had a 37% relative reduction in their urinary albumin-to-creatinine ratio (UACR), compared with placebo-treated patients after a median of 3 years on treatment.

Among the remaining 12,149 patients who did not receive an SGLT2 inhibitor, finerenone cut the average UACR by 32%, compared with placebo, said Peter Rossing, DMSc, MD, who presented the findings on Feb. 27 at the World Congress of Nephrology 2022 in Kuala Lumpur, Malaysia.

Primary endpoint results for FIDELIO-DKD and FIGARO-DKD also suggest similar additive effects of finerenone plus an SGLT2 inhibitor.

Results of the composite renal endpoint in each study – progression to kidney failure, renal death, or at least a 57% decline in estimated glomerular filtration rate (eGFR) from baseline – showed a 58% relative risk reduction in patients who received agents from both drug classes and a 20% relative risk reduction in those who only received finerenone, a between-group difference that was not significant.

For the composite cardiovascular event endpoint – cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure – the rate fell by 37%, compared with placebo, in patients who also received an SGLT2 inhibitor, and by 13%, compared with placebo, in those who received finerenone but no SGLT2 inhibitor, also a difference that was not significant.

‘A lot of interest in finerenone’ in U.S.

“The benefits of finerenone on cardiovascular and kidney outcomes were consistent, irrespective of SGLT2 inhibitor use at baseline,” concluded Dr. Rossing, professor and head of research at the Steno Diabetes Center in Copenhagen.

The new findings are a “suggestion that the two classes might be additive [in their effects], but more data are needed,” Dr. Rossing said during his presentation.

But he cautioned that in both pivotal trials randomization did not consider SGLT2 inhibitor use. All patients in the two trials were already receiving a renin-angiotensin system (RAS) inhibitor as background treatment, either an ACE inhibitor or angiotensin-receptor blocker.

The consequence of treatment with finerenone combined with an SGLT2 inhibitor is of growing importance because “an SGLT2 inhibitor is now recommended in most guidelines” for the type of patients enrolled in the two finerenone trials, explained Dr. Rossing.

He also noted that the first guideline to recommend routine use of finerenone in indicated patients appeared recently in the annual update to Standards of Medical Care in Diabetes – 2022 published by the American Diabetes Association.

The 2022 Standards states: “In patients with CKD who are at increased risk for cardiovascular events or CKD progression or are unable to use an SGLT2 inhibitor, a nonsteroidal mineralocorticoid receptor antagonist (finerenone) is recommended to reduce CKD progression and cardiovascular events.”

Results from FIDELIO-DKD, reported in the New England Journal of Medicine in 2020, and the main study, FIGARO-DKD, published in the same journal in 2021, led the Food and Drug Administration to approve finerenone in July 2021 to slow the progression of renal disease in patients with type 2 diabetes and CKD.

“My impression is that in the United States there is a lot of interest in finerenone,” Dr. Rossing said during the discussion following his presentation.

Finerenone has also been recently approved in the European Union.
 

‘Consistent’ benefits irrespective of SGLT2 inhibitors

“The cardiovascular and kidney benefits of finerenone were consistent irrespective of SGLT2 inhibitor use. This is definitely interesting and warrants a randomized controlled trial” to examine the relationship in a more rigorous way, commented Tejas Desai, MD, a nephrologist with the Department of Veterans Affairs, Charlotte, N.C.

That study, CONFIDENCE, is on its way, Dr. Rossing said during his talk. The randomized phase 2 trial has a planned enrollment of 800 patients with type 2 diabetes and CKD and three treatment groups: finerenone plus placebo, the SGLT2 inhibitor empagliflozin (Jardiance) plus placebo, or finerenone plus empagliflozin. The study will launch later in 2022 and has a planned completion date of late 2023.

“SGLT2 inhibitors, compared with finerenone, is where all of this is headed. We need a large trial that adjudicates the best medication to use with a RAS inhibitor,” Dr. Desai said in an interview.

The new analyses from the combined FIDELITY study expand on a previous report presented at the 2021 annual congress of the European Society of Cardiology and published in the European Heart Journal.
 

‘Impressive’ effect on cardiovascular events

The main findings from FIDELITY presented in those earlier reports, in 13,026 patients, showed there was a significant 14% relative reduction in the composite cardiovascular endpoint with finerenone, compared with placebo, during a median 3 years of follow-up.

The same report documented, in the total combined cohort, a significant 23% relative reduction in the composite renal endpoint in those taking finerenone compared with placebo.

“Reducing the risk of cardiovascular endpoints by a relative 14% is impressive,” and the time course showed a “relatively quick onset of action,” Dr. Desai noted.

He also characterized the enrolled patients, which included many with stage 3 or 4 CKD, as “not the sickest population of patients with CKD,” but rather “relatively healthier patients with CKD.”

Dr. Desai also downplayed the importance of the observed reduction in UACR associated with finerenone in FIDELITY.

“UACR is a surrogate marker. Results from many studies have shown improvements in UACR only to not show protection against falls in eGFR rate,” Dr. Desai said.

He was also reassured by the low incidence of hyperkalemia that led to discontinuation, which occurred in 1.7% of patients taking finerenone and in 0.6% of those taking placebo.

The types of patients enrolled in FIDELIO-DKD and FIGARO-DKD, who did not have eGFR rates below 25 mL/min per 1.73 m², are not particularly susceptible to this adverse effect, he said, noting, “I’m not overly concerned with hyperkalemia in this CKD population.

“I’m more concerned about [hyperkalemia in] patients with CKD and an eGFR of less than 25 mL/min per 1.73 m², but this was less than 1% of the enrolled population,” Dr. Desai observed.

FIDELIO-DKD, FIGARO-DKD, and FIDELITY were sponsored by Bayer, which markets finerenone (Kerendia). Dr. Rossing reported being a consultant for Bayer and other drug companies, and receiving research funding from AstraZeneca and Novo Nordisk. Dr. Desai reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Strong new evidence on the need to use an appropriately sized cuff in blood pressure measurement has come from the cross-sectional randomized trial Cuff(SZ).

The study found that in people in whom a small adult cuff was appropriate, systolic BP readings were on average 3.6 mm Hg lower when a regular adult size cuff was used.

However, systolic readings were on average 4.8 mm Hg higher when a regular cuff was used in people who required a large adult cuff and 19.5 mm Hg higher in those needing an extra-large cuff based on their mid-arm circumference.

The diastolic readings followed a similar pattern (-1.3 mm Hg, 1.8 mm Hg, and 7.4 mm Hg, respectively).

“We found that using the regular adult cuff in all individuals had striking differences in blood pressure,” lead author Tammy M. Brady, MD, PhD, Johns Hopkins University School of Medicine, Baltimore, told this news organization. “And that has a lot of clinical implications.”

A version of this article first appeared on Medscape.com.

Strong new evidence on the need to use an appropriately sized cuff in blood pressure measurement has come from the cross-sectional randomized trial Cuff(SZ).

The study found that in people in whom a small adult cuff was appropriate, systolic BP readings were on average 3.6 mm Hg lower when a regular adult size cuff was used.

However, systolic readings were on average 4.8 mm Hg higher when a regular cuff was used in people who required a large adult cuff and 19.5 mm Hg higher in those needing an extra-large cuff based on their mid-arm circumference.

The diastolic readings followed a similar pattern (-1.3 mm Hg, 1.8 mm Hg, and 7.4 mm Hg, respectively).

“We found that using the regular adult cuff in all individuals had striking differences in blood pressure,” lead author Tammy M. Brady, MD, PhD, Johns Hopkins University School of Medicine, Baltimore, told this news organization. “And that has a lot of clinical implications.”

A version of this article first appeared on Medscape.com.

Strong new evidence on the need to use an appropriately sized cuff in blood pressure measurement has come from the cross-sectional randomized trial Cuff(SZ).

The study found that in people in whom a small adult cuff was appropriate, systolic BP readings were on average 3.6 mm Hg lower when a regular adult size cuff was used.

However, systolic readings were on average 4.8 mm Hg higher when a regular cuff was used in people who required a large adult cuff and 19.5 mm Hg higher in those needing an extra-large cuff based on their mid-arm circumference.

The diastolic readings followed a similar pattern (-1.3 mm Hg, 1.8 mm Hg, and 7.4 mm Hg, respectively).

“We found that using the regular adult cuff in all individuals had striking differences in blood pressure,” lead author Tammy M. Brady, MD, PhD, Johns Hopkins University School of Medicine, Baltimore, told this news organization. “And that has a lot of clinical implications.”

A version of this article first appeared on Medscape.com.

Building on several previous reports that the newest models of mobile telephones and other electronics that use magnets pose a threat to the function of defibrillators and other implantable cardiovascular devices, a new study implicates any device that emits a 10-gauss (G) magnetic field more than a couple of inches.

“Beside the devices described in our manuscript, this can be any portable consumer product [with magnets] like electric cigarettes or smart watches,” explained study author Sven Knecht, DSc, a research electrophysiologist associated with the department of cardiology, University Hospital Basel (Switzerland).

In the newly published article, the investigators evaluated earphones, earphone charging cases, and two electronic pens used to draw on electronic tablets. These particular devices are of interest because, like mobile phones, they are of a size and shape to fit in a breast pocket adjacent to where many cardiovascular devices are implanted.

The study joins several previous studies that have shown the same risk, but this study used three-dimensional (3D) mapping of the magnetic field rather than a one-axis sensor, which is a standard adopted by the U.S. Food and Drug Administration, according to the investigators.
 

3D mapping assessment used

Because of the 3D nature of magnetic fields, 3D mapping serves as a better tool to assess the risk of the magnetic force as the intensity gradient diminishes with distance from the source, the authors contended. The 3D maps used in this study have a resolution to 2 mm.

The ex vivo measurements of the magnetic field, which could be displayed in a configurable 3D volume in relation to the electronic products were performed on five different explanted cardioverter defibrillators from two manufacturers.

In the ex vivo setting, the ability of the earphones, earphone charging cases, and electronic pens to interfere with defibrillator function was compared to that of the Apple iPhone 12 Max, which was the subject of a small in vivo study published in 2021. When the iPhone 12 Max was placed on the skin over a cardiac implantable device in that study, clinically identifiable interference could be detected in all 3 patients evaluated.

Based on previous work, the International Organization for Standardization has established that a minimal field strength of 10 G is needed to interfere with an implantable device, but the actual risk from any specific device is determined by the distance at which this strength of magnetic field is projected.

In the 3D analysis, the 10-G intensity was found to project 20 mm from the surface of the ear phones, ear phone charging case, and one of the electronic pens and to project 29 mm from the other electronic pen. When tested against the five defibrillators, magnetic reversion mode was triggered by the portable electronics at distances ranging from 8 to 18 mm.

In an interview, Dr. Knecht explained that this study adds more devices to the list of those associated with potential for interfering with implantable cardiovascular devices, but added that the more important point is that any device that contains magnets emitting a force of 10 G or greater for more than a few inches can be expected to be associated with clinically meaningful interference. The devices tested in this study were produced by Apple and Microsoft, but a focus on specific devices obscures the main message.

“All portable electronics with an embedded permanent magnet creating a 10-G magnetic field have a theoretical capability of triggering implantable devices,” he said.

For pacemakers, the interference is likely to trigger constant pacing, which would not be expected to pose a significant health threat if detected with a reasonable period, according to Dr. Knecht. Interference is potentially more serious for defibrillators, which might fail during magnetic interference to provide the shock needed to terminate a serious arrhythmia.

The combination of events – interference at the time of an arrhythmia – make this risk “very low,” but Dr. Knecht said it is sufficient to mean that patients receiving an implantable cardiovascular device should be made aware of the risk and the need to avoid placing portable electronic products near the implanted device.

When in vivo evidence of a disturbance with the iPhone 12 was reported in 2021, it amplified existing concern. The American Heart Association maintains a list of electronic products with the potential to interfere with implantable devices on its website. But, again, understanding the potential for risk and the need to keep electronic products with magnets at a safe distance from cardiovascular implantable devices is more important than trying to memorize the ever-growing list of devices with this capability.

“Prudent education of patients receiving an implantable device is important,” said N.A. Mark Estes III, MD, professor of medicine in the division of cardiology at the University of Pittsburgh. However, in an interview, he warned that the growing list of implicated devices makes a complete survey impractical, and, even if achievable, likely to leave patients “feeling overwhelmed.”
 

In Dr. Estes’s practice, he does provide printed information about the risks of electronics to interfere with implantable devices as well as a list of dos and don’ts. He agreed that the absolute risk of interference from a device causing significant clinical complications is low, but the goal is to “bring it as close to zero as possible.”

“No clinical case of a meaningful interaction of an electronic product and dysfunction of an implantable device has ever been documented,” he said. Given the widespread use of the new generation of cellphones that contain magnets powerful enough to induce dysfunction in an implantable device, “this speaks to the fact that the risk continues to be very low.”

Dr. Knecht and coinvestigators, along with Dr. Estes, reported no potential conflicts of interest.

Building on several previous reports that the newest models of mobile telephones and other electronics that use magnets pose a threat to the function of defibrillators and other implantable cardiovascular devices, a new study implicates any device that emits a 10-gauss (G) magnetic field more than a couple of inches.

“Beside the devices described in our manuscript, this can be any portable consumer product [with magnets] like electric cigarettes or smart watches,” explained study author Sven Knecht, DSc, a research electrophysiologist associated with the department of cardiology, University Hospital Basel (Switzerland).

In the newly published article, the investigators evaluated earphones, earphone charging cases, and two electronic pens used to draw on electronic tablets. These particular devices are of interest because, like mobile phones, they are of a size and shape to fit in a breast pocket adjacent to where many cardiovascular devices are implanted.

The study joins several previous studies that have shown the same risk, but this study used three-dimensional (3D) mapping of the magnetic field rather than a one-axis sensor, which is a standard adopted by the U.S. Food and Drug Administration, according to the investigators.
 

3D mapping assessment used

Because of the 3D nature of magnetic fields, 3D mapping serves as a better tool to assess the risk of the magnetic force as the intensity gradient diminishes with distance from the source, the authors contended. The 3D maps used in this study have a resolution to 2 mm.

The ex vivo measurements of the magnetic field, which could be displayed in a configurable 3D volume in relation to the electronic products were performed on five different explanted cardioverter defibrillators from two manufacturers.

In the ex vivo setting, the ability of the earphones, earphone charging cases, and electronic pens to interfere with defibrillator function was compared to that of the Apple iPhone 12 Max, which was the subject of a small in vivo study published in 2021. When the iPhone 12 Max was placed on the skin over a cardiac implantable device in that study, clinically identifiable interference could be detected in all 3 patients evaluated.

Based on previous work, the International Organization for Standardization has established that a minimal field strength of 10 G is needed to interfere with an implantable device, but the actual risk from any specific device is determined by the distance at which this strength of magnetic field is projected.

In the 3D analysis, the 10-G intensity was found to project 20 mm from the surface of the ear phones, ear phone charging case, and one of the electronic pens and to project 29 mm from the other electronic pen. When tested against the five defibrillators, magnetic reversion mode was triggered by the portable electronics at distances ranging from 8 to 18 mm.

In an interview, Dr. Knecht explained that this study adds more devices to the list of those associated with potential for interfering with implantable cardiovascular devices, but added that the more important point is that any device that contains magnets emitting a force of 10 G or greater for more than a few inches can be expected to be associated with clinically meaningful interference. The devices tested in this study were produced by Apple and Microsoft, but a focus on specific devices obscures the main message.

“All portable electronics with an embedded permanent magnet creating a 10-G magnetic field have a theoretical capability of triggering implantable devices,” he said.

For pacemakers, the interference is likely to trigger constant pacing, which would not be expected to pose a significant health threat if detected with a reasonable period, according to Dr. Knecht. Interference is potentially more serious for defibrillators, which might fail during magnetic interference to provide the shock needed to terminate a serious arrhythmia.

The combination of events – interference at the time of an arrhythmia – make this risk “very low,” but Dr. Knecht said it is sufficient to mean that patients receiving an implantable cardiovascular device should be made aware of the risk and the need to avoid placing portable electronic products near the implanted device.

When in vivo evidence of a disturbance with the iPhone 12 was reported in 2021, it amplified existing concern. The American Heart Association maintains a list of electronic products with the potential to interfere with implantable devices on its website. But, again, understanding the potential for risk and the need to keep electronic products with magnets at a safe distance from cardiovascular implantable devices is more important than trying to memorize the ever-growing list of devices with this capability.

“Prudent education of patients receiving an implantable device is important,” said N.A. Mark Estes III, MD, professor of medicine in the division of cardiology at the University of Pittsburgh. However, in an interview, he warned that the growing list of implicated devices makes a complete survey impractical, and, even if achievable, likely to leave patients “feeling overwhelmed.”
 

In Dr. Estes’s practice, he does provide printed information about the risks of electronics to interfere with implantable devices as well as a list of dos and don’ts. He agreed that the absolute risk of interference from a device causing significant clinical complications is low, but the goal is to “bring it as close to zero as possible.”

“No clinical case of a meaningful interaction of an electronic product and dysfunction of an implantable device has ever been documented,” he said. Given the widespread use of the new generation of cellphones that contain magnets powerful enough to induce dysfunction in an implantable device, “this speaks to the fact that the risk continues to be very low.”

Dr. Knecht and coinvestigators, along with Dr. Estes, reported no potential conflicts of interest.

Building on several previous reports that the newest models of mobile telephones and other electronics that use magnets pose a threat to the function of defibrillators and other implantable cardiovascular devices, a new study implicates any device that emits a 10-gauss (G) magnetic field more than a couple of inches.

“Beside the devices described in our manuscript, this can be any portable consumer product [with magnets] like electric cigarettes or smart watches,” explained study author Sven Knecht, DSc, a research electrophysiologist associated with the department of cardiology, University Hospital Basel (Switzerland).

In the newly published article, the investigators evaluated earphones, earphone charging cases, and two electronic pens used to draw on electronic tablets. These particular devices are of interest because, like mobile phones, they are of a size and shape to fit in a breast pocket adjacent to where many cardiovascular devices are implanted.

The study joins several previous studies that have shown the same risk, but this study used three-dimensional (3D) mapping of the magnetic field rather than a one-axis sensor, which is a standard adopted by the U.S. Food and Drug Administration, according to the investigators.
 

3D mapping assessment used

Because of the 3D nature of magnetic fields, 3D mapping serves as a better tool to assess the risk of the magnetic force as the intensity gradient diminishes with distance from the source, the authors contended. The 3D maps used in this study have a resolution to 2 mm.

The ex vivo measurements of the magnetic field, which could be displayed in a configurable 3D volume in relation to the electronic products were performed on five different explanted cardioverter defibrillators from two manufacturers.

In the ex vivo setting, the ability of the earphones, earphone charging cases, and electronic pens to interfere with defibrillator function was compared to that of the Apple iPhone 12 Max, which was the subject of a small in vivo study published in 2021. When the iPhone 12 Max was placed on the skin over a cardiac implantable device in that study, clinically identifiable interference could be detected in all 3 patients evaluated.

Based on previous work, the International Organization for Standardization has established that a minimal field strength of 10 G is needed to interfere with an implantable device, but the actual risk from any specific device is determined by the distance at which this strength of magnetic field is projected.

In the 3D analysis, the 10-G intensity was found to project 20 mm from the surface of the ear phones, ear phone charging case, and one of the electronic pens and to project 29 mm from the other electronic pen. When tested against the five defibrillators, magnetic reversion mode was triggered by the portable electronics at distances ranging from 8 to 18 mm.

In an interview, Dr. Knecht explained that this study adds more devices to the list of those associated with potential for interfering with implantable cardiovascular devices, but added that the more important point is that any device that contains magnets emitting a force of 10 G or greater for more than a few inches can be expected to be associated with clinically meaningful interference. The devices tested in this study were produced by Apple and Microsoft, but a focus on specific devices obscures the main message.

“All portable electronics with an embedded permanent magnet creating a 10-G magnetic field have a theoretical capability of triggering implantable devices,” he said.

For pacemakers, the interference is likely to trigger constant pacing, which would not be expected to pose a significant health threat if detected with a reasonable period, according to Dr. Knecht. Interference is potentially more serious for defibrillators, which might fail during magnetic interference to provide the shock needed to terminate a serious arrhythmia.

The combination of events – interference at the time of an arrhythmia – make this risk “very low,” but Dr. Knecht said it is sufficient to mean that patients receiving an implantable cardiovascular device should be made aware of the risk and the need to avoid placing portable electronic products near the implanted device.

When in vivo evidence of a disturbance with the iPhone 12 was reported in 2021, it amplified existing concern. The American Heart Association maintains a list of electronic products with the potential to interfere with implantable devices on its website. But, again, understanding the potential for risk and the need to keep electronic products with magnets at a safe distance from cardiovascular implantable devices is more important than trying to memorize the ever-growing list of devices with this capability.

“Prudent education of patients receiving an implantable device is important,” said N.A. Mark Estes III, MD, professor of medicine in the division of cardiology at the University of Pittsburgh. However, in an interview, he warned that the growing list of implicated devices makes a complete survey impractical, and, even if achievable, likely to leave patients “feeling overwhelmed.”
 

In Dr. Estes’s practice, he does provide printed information about the risks of electronics to interfere with implantable devices as well as a list of dos and don’ts. He agreed that the absolute risk of interference from a device causing significant clinical complications is low, but the goal is to “bring it as close to zero as possible.”

“No clinical case of a meaningful interaction of an electronic product and dysfunction of an implantable device has ever been documented,” he said. Given the widespread use of the new generation of cellphones that contain magnets powerful enough to induce dysfunction in an implantable device, “this speaks to the fact that the risk continues to be very low.”

Dr. Knecht and coinvestigators, along with Dr. Estes, reported no potential conflicts of interest.

Low-value health care services that provide little or no benefit to patients are “common, potentially harmful, and costly,” and there is a critical need to reduce this kind of care, the American Heart Association said in a newly released scientific statement.

Each year, nearly half of patients in the United States will receive at least one low-value test or procedure, with the attendant risk of avoidable complications from cascades of care and excess costs to individuals and society, the authors noted. Reducing low-value care is particularly important in cardiology, given the high prevalence and costs of cardiovascular disease in the United States.

The statement was published online Feb. 22, 2022, in Circulation: Cardiovascular Quality and Outcomes.
 

High burden with uncertain benefit

“Cardiovascular disease is common and can present suddenly, such as a heart attack or abnormal heart rhythm,” Vinay Kini, MD, chair of the statement writing group and assistant professor of medicine at Weill Cornell Medicine, New York, said in a news release.

“Our desire to be vigilant about treating and preventing cardiovascular disease may sometimes lead to use of tests and procedures where the benefits to patients may be uncertain,” Dr. Kini said. “This may impose burdens on patients, in the form of increased risk of physical harm from the low-value procedure or potential complications, as well as follow-up care and out-of-pocket financial costs.”

For example, studies have shown that up to one in five echocardiograms and up to half of all stress tests performed in the United States may be rated as rarely appropriate, based on established guidelines for their use.

In addition, up to 15% of percutaneous coronary interventions (PCIs) are classified as rarely appropriate, the writing group said.

Annually, among Medicare fee-for-service beneficiaries, low-value stress testing in patients with stable coronary artery disease is estimated to cost between $212 million and $2.1 billion, while costs of PCI for stable CAD range from $212 million to $2.8 billion, the writing group noted.

“At best, spending on low-value care potentially diverts resources from higher-value services that would benefit patients more effectively at the same or reduced cost. At worst, low-value care results in physical harm in the form of preventable morbidity and mortality,” they said.

“Thus, reducing low-value care is one of the few patient-centered solutions that directly address both the need to control health care spending and the societal imperative to devote its limited resources to beneficial health care services that improve health,” they added.

The group outlines several ways to reduce low-value cardiovascular care targeting patients, providers, and payers/policymakers.

For patients, education and shared decision-making may help reduce low-value care and dispel misconceptions about the intended purpose of test or treatment, they suggested.

For clinicians, a “layered” approach to reducing low-value care may be most effective, such as through education, audit and feedback, and behavioral science tools (“nudges”) to shift behaviors and practices, they said.

For payers and policy leaders, interventions to reduce low-value care include national insurance coverage determinations; prior authorization; alternative payment models that reward lower costs and higher-quality health care; value-based insurance designs that financially penalize low-value care; and medical liability reform to reduce defensive medical practices.

Low-value cardiovascular care is a complex problem, the writing group acknowledged, and achieving meaningful reductions in low-value cardiovascular care will require a multidisciplinary approach that includes continuous research, implementation, evaluation, and adjustment while ensuring equitable access to care.

“Each approach has benefits and drawbacks,” Dr. Kini said. “For example, prior authorization imposes a large burden on health care professionals to obtain insurance approval for tests and treatments. Prior authorization and some value-based payment models may unintentionally worsen existing racial and ethnic health care disparities.

“A one-size-fits-all approach to reducing low-value care is unlikely to succeed; rather, acting through multiple perspectives and frequently measuring impacts and potential unintended consequences is critical,” he concluded.

The scientific statement was prepared by the volunteer writing group on behalf of the AHA’s Council on Quality of Care and Outcomes Research.

The research had no commercial funding. Dr. Kini disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Low-value health care services that provide little or no benefit to patients are “common, potentially harmful, and costly,” and there is a critical need to reduce this kind of care, the American Heart Association said in a newly released scientific statement.

Each year, nearly half of patients in the United States will receive at least one low-value test or procedure, with the attendant risk of avoidable complications from cascades of care and excess costs to individuals and society, the authors noted. Reducing low-value care is particularly important in cardiology, given the high prevalence and costs of cardiovascular disease in the United States.

The statement was published online Feb. 22, 2022, in Circulation: Cardiovascular Quality and Outcomes.
 

High burden with uncertain benefit

“Cardiovascular disease is common and can present suddenly, such as a heart attack or abnormal heart rhythm,” Vinay Kini, MD, chair of the statement writing group and assistant professor of medicine at Weill Cornell Medicine, New York, said in a news release.

“Our desire to be vigilant about treating and preventing cardiovascular disease may sometimes lead to use of tests and procedures where the benefits to patients may be uncertain,” Dr. Kini said. “This may impose burdens on patients, in the form of increased risk of physical harm from the low-value procedure or potential complications, as well as follow-up care and out-of-pocket financial costs.”

For example, studies have shown that up to one in five echocardiograms and up to half of all stress tests performed in the United States may be rated as rarely appropriate, based on established guidelines for their use.

In addition, up to 15% of percutaneous coronary interventions (PCIs) are classified as rarely appropriate, the writing group said.

Annually, among Medicare fee-for-service beneficiaries, low-value stress testing in patients with stable coronary artery disease is estimated to cost between $212 million and $2.1 billion, while costs of PCI for stable CAD range from $212 million to $2.8 billion, the writing group noted.

“At best, spending on low-value care potentially diverts resources from higher-value services that would benefit patients more effectively at the same or reduced cost. At worst, low-value care results in physical harm in the form of preventable morbidity and mortality,” they said.

“Thus, reducing low-value care is one of the few patient-centered solutions that directly address both the need to control health care spending and the societal imperative to devote its limited resources to beneficial health care services that improve health,” they added.

The group outlines several ways to reduce low-value cardiovascular care targeting patients, providers, and payers/policymakers.

For patients, education and shared decision-making may help reduce low-value care and dispel misconceptions about the intended purpose of test or treatment, they suggested.

For clinicians, a “layered” approach to reducing low-value care may be most effective, such as through education, audit and feedback, and behavioral science tools (“nudges”) to shift behaviors and practices, they said.

For payers and policy leaders, interventions to reduce low-value care include national insurance coverage determinations; prior authorization; alternative payment models that reward lower costs and higher-quality health care; value-based insurance designs that financially penalize low-value care; and medical liability reform to reduce defensive medical practices.

Low-value cardiovascular care is a complex problem, the writing group acknowledged, and achieving meaningful reductions in low-value cardiovascular care will require a multidisciplinary approach that includes continuous research, implementation, evaluation, and adjustment while ensuring equitable access to care.

“Each approach has benefits and drawbacks,” Dr. Kini said. “For example, prior authorization imposes a large burden on health care professionals to obtain insurance approval for tests and treatments. Prior authorization and some value-based payment models may unintentionally worsen existing racial and ethnic health care disparities.

“A one-size-fits-all approach to reducing low-value care is unlikely to succeed; rather, acting through multiple perspectives and frequently measuring impacts and potential unintended consequences is critical,” he concluded.

The scientific statement was prepared by the volunteer writing group on behalf of the AHA’s Council on Quality of Care and Outcomes Research.

The research had no commercial funding. Dr. Kini disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Low-value health care services that provide little or no benefit to patients are “common, potentially harmful, and costly,” and there is a critical need to reduce this kind of care, the American Heart Association said in a newly released scientific statement.

Each year, nearly half of patients in the United States will receive at least one low-value test or procedure, with the attendant risk of avoidable complications from cascades of care and excess costs to individuals and society, the authors noted. Reducing low-value care is particularly important in cardiology, given the high prevalence and costs of cardiovascular disease in the United States.

The statement was published online Feb. 22, 2022, in Circulation: Cardiovascular Quality and Outcomes.
 

High burden with uncertain benefit

“Cardiovascular disease is common and can present suddenly, such as a heart attack or abnormal heart rhythm,” Vinay Kini, MD, chair of the statement writing group and assistant professor of medicine at Weill Cornell Medicine, New York, said in a news release.

“Our desire to be vigilant about treating and preventing cardiovascular disease may sometimes lead to use of tests and procedures where the benefits to patients may be uncertain,” Dr. Kini said. “This may impose burdens on patients, in the form of increased risk of physical harm from the low-value procedure or potential complications, as well as follow-up care and out-of-pocket financial costs.”

For example, studies have shown that up to one in five echocardiograms and up to half of all stress tests performed in the United States may be rated as rarely appropriate, based on established guidelines for their use.

In addition, up to 15% of percutaneous coronary interventions (PCIs) are classified as rarely appropriate, the writing group said.

Annually, among Medicare fee-for-service beneficiaries, low-value stress testing in patients with stable coronary artery disease is estimated to cost between $212 million and $2.1 billion, while costs of PCI for stable CAD range from $212 million to $2.8 billion, the writing group noted.

“At best, spending on low-value care potentially diverts resources from higher-value services that would benefit patients more effectively at the same or reduced cost. At worst, low-value care results in physical harm in the form of preventable morbidity and mortality,” they said.

“Thus, reducing low-value care is one of the few patient-centered solutions that directly address both the need to control health care spending and the societal imperative to devote its limited resources to beneficial health care services that improve health,” they added.

The group outlines several ways to reduce low-value cardiovascular care targeting patients, providers, and payers/policymakers.

For patients, education and shared decision-making may help reduce low-value care and dispel misconceptions about the intended purpose of test or treatment, they suggested.

For clinicians, a “layered” approach to reducing low-value care may be most effective, such as through education, audit and feedback, and behavioral science tools (“nudges”) to shift behaviors and practices, they said.

For payers and policy leaders, interventions to reduce low-value care include national insurance coverage determinations; prior authorization; alternative payment models that reward lower costs and higher-quality health care; value-based insurance designs that financially penalize low-value care; and medical liability reform to reduce defensive medical practices.

Low-value cardiovascular care is a complex problem, the writing group acknowledged, and achieving meaningful reductions in low-value cardiovascular care will require a multidisciplinary approach that includes continuous research, implementation, evaluation, and adjustment while ensuring equitable access to care.

“Each approach has benefits and drawbacks,” Dr. Kini said. “For example, prior authorization imposes a large burden on health care professionals to obtain insurance approval for tests and treatments. Prior authorization and some value-based payment models may unintentionally worsen existing racial and ethnic health care disparities.

“A one-size-fits-all approach to reducing low-value care is unlikely to succeed; rather, acting through multiple perspectives and frequently measuring impacts and potential unintended consequences is critical,” he concluded.

The scientific statement was prepared by the volunteer writing group on behalf of the AHA’s Council on Quality of Care and Outcomes Research.

The research had no commercial funding. Dr. Kini disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved an expanded heart failure indication for the sodium-glucose transporter 2 inhibitor empagliflozin (Jardiance) that now includes HF with mid-range or preserved left ventricular ejection fraction (LVEF), the agency announced on Feb. 24.

That means the SGLT2 inhibitor, once considered primarily an antidiabetic agent, is approved for use in patients with HF per se without regard to ventricular function. The drug received approval for HF with reduced LVEF in August 2021.

Olivier Le Moal/Getty Images

The expanded indication, specifically for reducing the risk of cardiovascular death and HF hospitalization in adults, was widely anticipated based on the landmark results from the EMPEROR-Preserved trial. The study saw a significant 21% relative reduction in that composite endpoint over about 2 years in patients with New York Heart Association class II-IV heart failure and an LVEF greater than 40% who received empagliflozin along with other standard care.

Interestingly, the drug’s expanded indication in HF resembles that approved for sacubitril/valsartan (Entresto) in February 2021 based mostly on the PARAGON-HF trial, which entered patients with HF and an LVEF at least 45%. The trial was “negative” in that it saw no significant advantage to the drug for its primary clinical outcome but did suggest benefit for some secondary endpoints.

The FDA had used more cautionary language in its expanded indication for sacubitril/valsartan, “to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction below normal.”

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved an expanded heart failure indication for the sodium-glucose transporter 2 inhibitor empagliflozin (Jardiance) that now includes HF with mid-range or preserved left ventricular ejection fraction (LVEF), the agency announced on Feb. 24.

That means the SGLT2 inhibitor, once considered primarily an antidiabetic agent, is approved for use in patients with HF per se without regard to ventricular function. The drug received approval for HF with reduced LVEF in August 2021.

Olivier Le Moal/Getty Images

The expanded indication, specifically for reducing the risk of cardiovascular death and HF hospitalization in adults, was widely anticipated based on the landmark results from the EMPEROR-Preserved trial. The study saw a significant 21% relative reduction in that composite endpoint over about 2 years in patients with New York Heart Association class II-IV heart failure and an LVEF greater than 40% who received empagliflozin along with other standard care.

Interestingly, the drug’s expanded indication in HF resembles that approved for sacubitril/valsartan (Entresto) in February 2021 based mostly on the PARAGON-HF trial, which entered patients with HF and an LVEF at least 45%. The trial was “negative” in that it saw no significant advantage to the drug for its primary clinical outcome but did suggest benefit for some secondary endpoints.

The FDA had used more cautionary language in its expanded indication for sacubitril/valsartan, “to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction below normal.”

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved an expanded heart failure indication for the sodium-glucose transporter 2 inhibitor empagliflozin (Jardiance) that now includes HF with mid-range or preserved left ventricular ejection fraction (LVEF), the agency announced on Feb. 24.

That means the SGLT2 inhibitor, once considered primarily an antidiabetic agent, is approved for use in patients with HF per se without regard to ventricular function. The drug received approval for HF with reduced LVEF in August 2021.

Olivier Le Moal/Getty Images

The expanded indication, specifically for reducing the risk of cardiovascular death and HF hospitalization in adults, was widely anticipated based on the landmark results from the EMPEROR-Preserved trial. The study saw a significant 21% relative reduction in that composite endpoint over about 2 years in patients with New York Heart Association class II-IV heart failure and an LVEF greater than 40% who received empagliflozin along with other standard care.

Interestingly, the drug’s expanded indication in HF resembles that approved for sacubitril/valsartan (Entresto) in February 2021 based mostly on the PARAGON-HF trial, which entered patients with HF and an LVEF at least 45%. The trial was “negative” in that it saw no significant advantage to the drug for its primary clinical outcome but did suggest benefit for some secondary endpoints.

The FDA had used more cautionary language in its expanded indication for sacubitril/valsartan, “to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction below normal.”

A version of this article first appeared on Medscape.com.

On Feb. 15, Robert Califf, MD, narrowly won Senate confirmation to once again serve as the commissioner of the Food and Drug Administration, overcoming protest votes from lawmakers about abortion and opioid issues.

FDA photo by Michael J. Ermarth

The Senate voted 50-46 in favor of Dr. Califf’s nomination. A cardiologist long affiliated with Duke University and a noted expert on clinical trials, Dr. Califf also led the FDA from February 2016 through January 2017.

In 2016, the Senate confirmed him as FDA chief in an 89-4 vote. At that time, Sen. Joe Manchin, D-WV, and a few other senators said they were concerned that Dr. Califf’s links to the drug industry would hamper his ability to regulate drugmakers, particularly in terms of rules on prescription painkillers.

Sen. Manchin also objected to Dr. Califf’s second nomination as FDA commissioner, as did several fellow Democrats, including Sen. Edward Markey of Massachusetts. In a statement issued after the Feb. 15 vote, Sen. Markey said he has “consistently raised concerns about the FDA’s egregious mishandling of opioid approvals and its role in enabling the current opioid epidemic.”

“To date, the FDA still has not implemented many of the reforms necessary to ensure that it is fulfilling its role as our nation’s top pharmaceutical cop on the beat,” Sen. Markey said. “I have not received any real commitment from Dr. Califf to truly reform the FDA or to learn from the failures that fueled this public health crisis.”

This time, Dr. Califf lost support among Republican senators due to objections raised by groups seeking to end women’s access to abortion. Susan B. Anthony List and National Right to Life asked senators in a January letter to oppose Dr. Califf’s nomination, citing their objections to how the FDA handled reporting of adverse events from abortions by medication during Dr. Califf’s Tenure.

But some Republicans supported Califf in the Tuesday vote. Sens. Roy Blunt of Missouri, Richard Burr of North Carolina, Susan Collins of Maine, Lisa Murkowski of Alaska, Mitt Romney of Utah, and Pat Toomey of Pennsylvania all voted in his favor.

On Feb. 14, Sen. Patty Murray, D-WA, chairwoman of the Senate Health, Education, Labor, and Pensions Committee, urged her colleagues to vote for Dr. Califf to give the FDA strong leadership to tackle urgent health needs such as the opioid crisis, youth tobacco use, antimicrobial resistance, and inequities in health care.

“At this critical moment, we need a trusted hand to lead the FDA,” she said in a floor speech. Dr. Califf’s previous service at the FDA and his years spent as a research scientist “give him the experience to take on this challenge.”

Separately, three former FDA commissioners on Feb. 15 published an opinion article that appeared in The Hill. Republican presidents nominated two of these former FDA chiefs: Scott Gottlieb, MD, and Mark McClellan, MD. The third, Margaret Hamburg, MD, was nominated by President Barack Obama, as was Dr. Califf for his first time as FDA chief.

There’s an urgent need for a confirmed leader at the FDA as the United States seeks to move beyond the pandemic, the former FDA chiefs wrote. The work ahead includes continued efforts with vaccines as well as efforts to bolster medical supply chains, they said.

Dr. Califf “knows how to advance the safe development and use of medical products and to bring a sound, science-based foundation to the FDA’s regulatory actions. Because of this, he has earned the confidence of FDA’s professional career staff, as well as a broad base of patient groups, academic experts, medical professionals, and public health organizations,” Dr. Gottlieb, Dr. Hamburg, and Dr. McClellan wrote.

The article also was signed by former Centers for Medicare and Medicaid Services Administrator Andy Slavitt, who served in the Obama administration.
 

Support of medical community

The American Heart Association issued a statement on Feb.15, congratulating Dr. Califf on his second confirmation after the Senate vote.

“With a distinguished career in public service and a long-time volunteer leader at the American Heart Association, Dr. Califf has honed his ability to communicate and build trust with diverse constituencies,” CEO Nancy Brown said in the statement. “He will use his experience as a cardiologist to safeguard the health and well-being of people throughout the country, and his background in research to prioritize science and evidence-based policymaking.”

Dr. Califf was also backed by the Association of American Medical Colleges, the American Academy of Pediatrics, the American Academy of Family Physicians, and the American College of Physicians when he was nominated for the role last year by President Joe Biden.

A version of this article first appeared on Medscape.com.

On Feb. 15, Robert Califf, MD, narrowly won Senate confirmation to once again serve as the commissioner of the Food and Drug Administration, overcoming protest votes from lawmakers about abortion and opioid issues.

FDA photo by Michael J. Ermarth

The Senate voted 50-46 in favor of Dr. Califf’s nomination. A cardiologist long affiliated with Duke University and a noted expert on clinical trials, Dr. Califf also led the FDA from February 2016 through January 2017.

In 2016, the Senate confirmed him as FDA chief in an 89-4 vote. At that time, Sen. Joe Manchin, D-WV, and a few other senators said they were concerned that Dr. Califf’s links to the drug industry would hamper his ability to regulate drugmakers, particularly in terms of rules on prescription painkillers.

Sen. Manchin also objected to Dr. Califf’s second nomination as FDA commissioner, as did several fellow Democrats, including Sen. Edward Markey of Massachusetts. In a statement issued after the Feb. 15 vote, Sen. Markey said he has “consistently raised concerns about the FDA’s egregious mishandling of opioid approvals and its role in enabling the current opioid epidemic.”

“To date, the FDA still has not implemented many of the reforms necessary to ensure that it is fulfilling its role as our nation’s top pharmaceutical cop on the beat,” Sen. Markey said. “I have not received any real commitment from Dr. Califf to truly reform the FDA or to learn from the failures that fueled this public health crisis.”

This time, Dr. Califf lost support among Republican senators due to objections raised by groups seeking to end women’s access to abortion. Susan B. Anthony List and National Right to Life asked senators in a January letter to oppose Dr. Califf’s nomination, citing their objections to how the FDA handled reporting of adverse events from abortions by medication during Dr. Califf’s Tenure.

But some Republicans supported Califf in the Tuesday vote. Sens. Roy Blunt of Missouri, Richard Burr of North Carolina, Susan Collins of Maine, Lisa Murkowski of Alaska, Mitt Romney of Utah, and Pat Toomey of Pennsylvania all voted in his favor.

On Feb. 14, Sen. Patty Murray, D-WA, chairwoman of the Senate Health, Education, Labor, and Pensions Committee, urged her colleagues to vote for Dr. Califf to give the FDA strong leadership to tackle urgent health needs such as the opioid crisis, youth tobacco use, antimicrobial resistance, and inequities in health care.

“At this critical moment, we need a trusted hand to lead the FDA,” she said in a floor speech. Dr. Califf’s previous service at the FDA and his years spent as a research scientist “give him the experience to take on this challenge.”

Separately, three former FDA commissioners on Feb. 15 published an opinion article that appeared in The Hill. Republican presidents nominated two of these former FDA chiefs: Scott Gottlieb, MD, and Mark McClellan, MD. The third, Margaret Hamburg, MD, was nominated by President Barack Obama, as was Dr. Califf for his first time as FDA chief.

There’s an urgent need for a confirmed leader at the FDA as the United States seeks to move beyond the pandemic, the former FDA chiefs wrote. The work ahead includes continued efforts with vaccines as well as efforts to bolster medical supply chains, they said.

Dr. Califf “knows how to advance the safe development and use of medical products and to bring a sound, science-based foundation to the FDA’s regulatory actions. Because of this, he has earned the confidence of FDA’s professional career staff, as well as a broad base of patient groups, academic experts, medical professionals, and public health organizations,” Dr. Gottlieb, Dr. Hamburg, and Dr. McClellan wrote.

The article also was signed by former Centers for Medicare and Medicaid Services Administrator Andy Slavitt, who served in the Obama administration.
 

Support of medical community

The American Heart Association issued a statement on Feb.15, congratulating Dr. Califf on his second confirmation after the Senate vote.

“With a distinguished career in public service and a long-time volunteer leader at the American Heart Association, Dr. Califf has honed his ability to communicate and build trust with diverse constituencies,” CEO Nancy Brown said in the statement. “He will use his experience as a cardiologist to safeguard the health and well-being of people throughout the country, and his background in research to prioritize science and evidence-based policymaking.”

Dr. Califf was also backed by the Association of American Medical Colleges, the American Academy of Pediatrics, the American Academy of Family Physicians, and the American College of Physicians when he was nominated for the role last year by President Joe Biden.

A version of this article first appeared on Medscape.com.

On Feb. 15, Robert Califf, MD, narrowly won Senate confirmation to once again serve as the commissioner of the Food and Drug Administration, overcoming protest votes from lawmakers about abortion and opioid issues.

FDA photo by Michael J. Ermarth

The Senate voted 50-46 in favor of Dr. Califf’s nomination. A cardiologist long affiliated with Duke University and a noted expert on clinical trials, Dr. Califf also led the FDA from February 2016 through January 2017.

In 2016, the Senate confirmed him as FDA chief in an 89-4 vote. At that time, Sen. Joe Manchin, D-WV, and a few other senators said they were concerned that Dr. Califf’s links to the drug industry would hamper his ability to regulate drugmakers, particularly in terms of rules on prescription painkillers.

Sen. Manchin also objected to Dr. Califf’s second nomination as FDA commissioner, as did several fellow Democrats, including Sen. Edward Markey of Massachusetts. In a statement issued after the Feb. 15 vote, Sen. Markey said he has “consistently raised concerns about the FDA’s egregious mishandling of opioid approvals and its role in enabling the current opioid epidemic.”

“To date, the FDA still has not implemented many of the reforms necessary to ensure that it is fulfilling its role as our nation’s top pharmaceutical cop on the beat,” Sen. Markey said. “I have not received any real commitment from Dr. Califf to truly reform the FDA or to learn from the failures that fueled this public health crisis.”

This time, Dr. Califf lost support among Republican senators due to objections raised by groups seeking to end women’s access to abortion. Susan B. Anthony List and National Right to Life asked senators in a January letter to oppose Dr. Califf’s nomination, citing their objections to how the FDA handled reporting of adverse events from abortions by medication during Dr. Califf’s Tenure.

But some Republicans supported Califf in the Tuesday vote. Sens. Roy Blunt of Missouri, Richard Burr of North Carolina, Susan Collins of Maine, Lisa Murkowski of Alaska, Mitt Romney of Utah, and Pat Toomey of Pennsylvania all voted in his favor.

On Feb. 14, Sen. Patty Murray, D-WA, chairwoman of the Senate Health, Education, Labor, and Pensions Committee, urged her colleagues to vote for Dr. Califf to give the FDA strong leadership to tackle urgent health needs such as the opioid crisis, youth tobacco use, antimicrobial resistance, and inequities in health care.

“At this critical moment, we need a trusted hand to lead the FDA,” she said in a floor speech. Dr. Califf’s previous service at the FDA and his years spent as a research scientist “give him the experience to take on this challenge.”

Separately, three former FDA commissioners on Feb. 15 published an opinion article that appeared in The Hill. Republican presidents nominated two of these former FDA chiefs: Scott Gottlieb, MD, and Mark McClellan, MD. The third, Margaret Hamburg, MD, was nominated by President Barack Obama, as was Dr. Califf for his first time as FDA chief.

There’s an urgent need for a confirmed leader at the FDA as the United States seeks to move beyond the pandemic, the former FDA chiefs wrote. The work ahead includes continued efforts with vaccines as well as efforts to bolster medical supply chains, they said.

Dr. Califf “knows how to advance the safe development and use of medical products and to bring a sound, science-based foundation to the FDA’s regulatory actions. Because of this, he has earned the confidence of FDA’s professional career staff, as well as a broad base of patient groups, academic experts, medical professionals, and public health organizations,” Dr. Gottlieb, Dr. Hamburg, and Dr. McClellan wrote.

The article also was signed by former Centers for Medicare and Medicaid Services Administrator Andy Slavitt, who served in the Obama administration.
 

Support of medical community

The American Heart Association issued a statement on Feb.15, congratulating Dr. Califf on his second confirmation after the Senate vote.

“With a distinguished career in public service and a long-time volunteer leader at the American Heart Association, Dr. Califf has honed his ability to communicate and build trust with diverse constituencies,” CEO Nancy Brown said in the statement. “He will use his experience as a cardiologist to safeguard the health and well-being of people throughout the country, and his background in research to prioritize science and evidence-based policymaking.”

Dr. Califf was also backed by the Association of American Medical Colleges, the American Academy of Pediatrics, the American Academy of Family Physicians, and the American College of Physicians when he was nominated for the role last year by President Joe Biden.

A version of this article first appeared on Medscape.com.