Anticoagulation Hub

BARCELONA – Oral anticoagulation had a net overall benefit for patients with atrial fibrillation and advanced chronic kidney disease, based on results of a large observational study reported at the annual congress of the European Society of Cardiology.

The novel direct-acting oral anticoagulants (NOACs) and warfarin were all similarly effective in this study of 39,241 patients who had stage 4 or 5 chronic kidney disease (CKD), atrial fibrillation, and were not on dialysis. Compared with no oral anticoagulation, the drugs cut in half the risk of stroke or systemic embolism, with no increased risk of major bleeding.

“In patients with advanced CKD, it appears that OACs [oral anticoagulants] are reasonable,” concluded Peter A. Noseworthy, MD, of the Mayo Clinic in Rochester, Minn.

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BARCELONA – Oral anticoagulation had a net overall benefit for patients with atrial fibrillation and advanced chronic kidney disease, based on results of a large observational study reported at the annual congress of the European Society of Cardiology.

The novel direct-acting oral anticoagulants (NOACs) and warfarin were all similarly effective in this study of 39,241 patients who had stage 4 or 5 chronic kidney disease (CKD), atrial fibrillation, and were not on dialysis. Compared with no oral anticoagulation, the drugs cut in half the risk of stroke or systemic embolism, with no increased risk of major bleeding.

“In patients with advanced CKD, it appears that OACs [oral anticoagulants] are reasonable,” concluded Peter A. Noseworthy, MD, of the Mayo Clinic in Rochester, Minn.

[email protected]

BARCELONA – Oral anticoagulation had a net overall benefit for patients with atrial fibrillation and advanced chronic kidney disease, based on results of a large observational study reported at the annual congress of the European Society of Cardiology.

The novel direct-acting oral anticoagulants (NOACs) and warfarin were all similarly effective in this study of 39,241 patients who had stage 4 or 5 chronic kidney disease (CKD), atrial fibrillation, and were not on dialysis. Compared with no oral anticoagulation, the drugs cut in half the risk of stroke or systemic embolism, with no increased risk of major bleeding.

“In patients with advanced CKD, it appears that OACs [oral anticoagulants] are reasonable,” concluded Peter A. Noseworthy, MD, of the Mayo Clinic in Rochester, Minn.

[email protected]

BARCELONA – A program promoting broader anticoagulation of patients with atrial fibrillation that used education and feedback from practice audits produced a substantial increase in sustained anticoagulant use and cut strokes in a multinational study with almost 2,300 patients in 48 practices.

Among atrial fibrillation (AF) patients who were not on an anticoagulant at baseline (34% of the enrolled group) 48% of patients in the intervention group began anticoagulant treatment and remained on it for a year with intervention compared with 18% of patients in the control arm without the intervention, Christopher B. Granger, MD, said at the annual congress of the European Society of Cardiology.

The intervention, which highlighted to health care providers the opportunity to start their AF patients on anticoagulant treatment, “transforms how care is provided to this population” of AF patients, Dr. Granger said in a video interview. “Doing something like this can have enormous public health implications.”

IMPACT AF (The Clinical Trial to Improve Treatment With Blood Thinners in Patients With Atrial Fibrillation) randomized 2,281 AF patients in 48 practices in five middle-income countries: Argentina, Brazil, China, India, and Romania. Randomization was by practice, and patients were assigned to either usual care or to an intervention that ran educational sessions for patients and providers on the benefits of and best practices for using anticoagulants. The intervention also monitored anticoagulant use by the patients in each practice and gave providers case-by-case feedback on the care patients received. The educational component customized the feedback to focus on overcoming treatment barriers specific for each patient. This audit and feedback process was a key part of the intervention, Dr. Granger said.

In an adjusted analysis, among patients not on an anticoagulant at baseline, the ones managed in practices that received the intervention had a greater than fourfold likelihood of receiving anticoagulant treatment, compared with patients in practices with no intervention. The intervention was especially successful in transitioning patients off of aspirin treatment, considered ineffective for AF stroke prevention, and onto an anticoagulant, most commonly warfarin.

Overall, anticoagulant use rose by 12 percentage points from baseline among patients in the intervention practices and by 3 percentage points over baseline among the control patients, a statistically significant difference for the study’s primary endpoint.

During 1-year follow-up, 11 strokes occurred among patients managed in practices that received the intervention and 21 in those in control practices, a 52% relative hazard reduction linked with the intervention that was statistically significant, Dr. Granger reported. Concurrently with his talk, the results also appeared online (Lancet. 2017. doi: 10.1016/S0140-6736[17]32165-7).

“How will we take what we have learned [in IMPACT AF] and have it available to people who want to replicate this?” asked Dr. Granger. “We have partnered with several national cardiology societies, and we are working with them to optimize the tools and provide the tools we’ve used,” he said. “We will develop a website for people who want to take this information and use it in their practices.” Dr. Granger and his associates also are working with the Food and Drug Administration and other groups to come up with interventions specially designed for U.S. practice.

IMPACT AF received partial funding from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, and Pfizer. Dr. Granger has received honoraria and research funding from all of these companies, and also from Janssen and Medtronic.

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On Twitter @mitchelzoler

BARCELONA – A program promoting broader anticoagulation of patients with atrial fibrillation that used education and feedback from practice audits produced a substantial increase in sustained anticoagulant use and cut strokes in a multinational study with almost 2,300 patients in 48 practices.

Among atrial fibrillation (AF) patients who were not on an anticoagulant at baseline (34% of the enrolled group) 48% of patients in the intervention group began anticoagulant treatment and remained on it for a year with intervention compared with 18% of patients in the control arm without the intervention, Christopher B. Granger, MD, said at the annual congress of the European Society of Cardiology.

The intervention, which highlighted to health care providers the opportunity to start their AF patients on anticoagulant treatment, “transforms how care is provided to this population” of AF patients, Dr. Granger said in a video interview. “Doing something like this can have enormous public health implications.”

IMPACT AF (The Clinical Trial to Improve Treatment With Blood Thinners in Patients With Atrial Fibrillation) randomized 2,281 AF patients in 48 practices in five middle-income countries: Argentina, Brazil, China, India, and Romania. Randomization was by practice, and patients were assigned to either usual care or to an intervention that ran educational sessions for patients and providers on the benefits of and best practices for using anticoagulants. The intervention also monitored anticoagulant use by the patients in each practice and gave providers case-by-case feedback on the care patients received. The educational component customized the feedback to focus on overcoming treatment barriers specific for each patient. This audit and feedback process was a key part of the intervention, Dr. Granger said.

In an adjusted analysis, among patients not on an anticoagulant at baseline, the ones managed in practices that received the intervention had a greater than fourfold likelihood of receiving anticoagulant treatment, compared with patients in practices with no intervention. The intervention was especially successful in transitioning patients off of aspirin treatment, considered ineffective for AF stroke prevention, and onto an anticoagulant, most commonly warfarin.

Overall, anticoagulant use rose by 12 percentage points from baseline among patients in the intervention practices and by 3 percentage points over baseline among the control patients, a statistically significant difference for the study’s primary endpoint.

During 1-year follow-up, 11 strokes occurred among patients managed in practices that received the intervention and 21 in those in control practices, a 52% relative hazard reduction linked with the intervention that was statistically significant, Dr. Granger reported. Concurrently with his talk, the results also appeared online (Lancet. 2017. doi: 10.1016/S0140-6736[17]32165-7).

“How will we take what we have learned [in IMPACT AF] and have it available to people who want to replicate this?” asked Dr. Granger. “We have partnered with several national cardiology societies, and we are working with them to optimize the tools and provide the tools we’ve used,” he said. “We will develop a website for people who want to take this information and use it in their practices.” Dr. Granger and his associates also are working with the Food and Drug Administration and other groups to come up with interventions specially designed for U.S. practice.

IMPACT AF received partial funding from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, and Pfizer. Dr. Granger has received honoraria and research funding from all of these companies, and also from Janssen and Medtronic.

[email protected]

On Twitter @mitchelzoler

BARCELONA – A program promoting broader anticoagulation of patients with atrial fibrillation that used education and feedback from practice audits produced a substantial increase in sustained anticoagulant use and cut strokes in a multinational study with almost 2,300 patients in 48 practices.

Among atrial fibrillation (AF) patients who were not on an anticoagulant at baseline (34% of the enrolled group) 48% of patients in the intervention group began anticoagulant treatment and remained on it for a year with intervention compared with 18% of patients in the control arm without the intervention, Christopher B. Granger, MD, said at the annual congress of the European Society of Cardiology.

The intervention, which highlighted to health care providers the opportunity to start their AF patients on anticoagulant treatment, “transforms how care is provided to this population” of AF patients, Dr. Granger said in a video interview. “Doing something like this can have enormous public health implications.”

IMPACT AF (The Clinical Trial to Improve Treatment With Blood Thinners in Patients With Atrial Fibrillation) randomized 2,281 AF patients in 48 practices in five middle-income countries: Argentina, Brazil, China, India, and Romania. Randomization was by practice, and patients were assigned to either usual care or to an intervention that ran educational sessions for patients and providers on the benefits of and best practices for using anticoagulants. The intervention also monitored anticoagulant use by the patients in each practice and gave providers case-by-case feedback on the care patients received. The educational component customized the feedback to focus on overcoming treatment barriers specific for each patient. This audit and feedback process was a key part of the intervention, Dr. Granger said.

In an adjusted analysis, among patients not on an anticoagulant at baseline, the ones managed in practices that received the intervention had a greater than fourfold likelihood of receiving anticoagulant treatment, compared with patients in practices with no intervention. The intervention was especially successful in transitioning patients off of aspirin treatment, considered ineffective for AF stroke prevention, and onto an anticoagulant, most commonly warfarin.

Overall, anticoagulant use rose by 12 percentage points from baseline among patients in the intervention practices and by 3 percentage points over baseline among the control patients, a statistically significant difference for the study’s primary endpoint.

During 1-year follow-up, 11 strokes occurred among patients managed in practices that received the intervention and 21 in those in control practices, a 52% relative hazard reduction linked with the intervention that was statistically significant, Dr. Granger reported. Concurrently with his talk, the results also appeared online (Lancet. 2017. doi: 10.1016/S0140-6736[17]32165-7).

“How will we take what we have learned [in IMPACT AF] and have it available to people who want to replicate this?” asked Dr. Granger. “We have partnered with several national cardiology societies, and we are working with them to optimize the tools and provide the tools we’ve used,” he said. “We will develop a website for people who want to take this information and use it in their practices.” Dr. Granger and his associates also are working with the Food and Drug Administration and other groups to come up with interventions specially designed for U.S. practice.

IMPACT AF received partial funding from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, and Pfizer. Dr. Granger has received honoraria and research funding from all of these companies, and also from Janssen and Medtronic.

[email protected]

On Twitter @mitchelzoler

Three separate trials examining the impact of closing a patent foramen ovale on the risk of stroke all point to endovascular closure offering a greater reduction in risk than with anticoagulant or antiplatelet therapy alone.

However, this benefit may be evident only in patients at higher risk of stroke associated with patent foramen ovale (PFO), and comes at the cost of an increased risk of atrial fibrillation and procedure-related adverse events, according to papers published in the Sept. 14 issue of the New England Journal of Medicine.
 

Closure plus anticoagulation vs. anticoagulation or antiplatelets alone

In the CLOSE trial, 663 patients aged 16-60 years who had experienced a recent stroke attributed to PFO and who had an associated atrial septal aneurysm or large interatrial shunt were randomized to transcatheter closure plus long-term antiplatelet therapy, antiplatelets alone, or oral anticoagulation alone.

After a mean follow-up of 5.3 years, Jean‑Louis Mas, MD, of Sainte-Anne Hospital, Paris, and his colleagues reported that there were no recurrent strokes in the closure group, but 14 of the 235 patients in the antiplatelets-only group experienced a stroke, representing a 97% reduction in the risk of stroke with endovascular closure (P less than .001). Patients in the antiplatelets-only group had a 4.9% overall probability of stroke, and no explanation other than PFO could be found for their recurrent stroke (N Engl J Med. 2017;377:1011-21), reported .

The study was not adequately powered to compare the outcomes of anticoagulant therapy with antiplatelet therapy alone.

The closure group also had a 61% lower risk of the secondary composite outcome of stroke, transient ischemic attack, or systemic embolism, compared with the antiplatelet-only group (P = .01).

However, closure of the PFO was associated with a higher rate of new-onset atrial fibrillation or flutter than antiplatelet therapy alone (4.6% vs. 0.9%, P = .02), and major procedural complications occurred in 5.9% of patients.
 

Closure plus antiplatelets vs. antiplatelets alone

In the second study – REDUCE – 664 patients with PFO who had experienced an ischemic stroke with no other obvious cause were randomized either to closure plus antiplatelet therapy or antiplatelet therapy alone (N Engl J Med. 2017;377:1033-42).

Over the median follow-up of 3.2 years, there were ischemic strokes in 1.4% of patients in the closure group, compared with 5.4% in the antiplatelet-only group; this was a 77% reduction in risk (P = .002), Lars Søndergaard, MD, of the University of Copenhagen, and his coauthors reported.

The closure group also had a 49% lower incidence of new brain infarctions, compared with the antiplatelet-only group, although the incidence of silent brain infarction was similar between the two groups.

While the risks of major bleeding, deep-vein thrombosis, and pulmonary embolism and serious adverse events were similar between the two groups, the closure group had a 2.5% rate of procedure-related serious adverse events and 1.4% rate of device-related serious adverse events. The closure group also had a significantly higher incidence of atrial fibrillation when compared with the control group (6.6% vs. 0.4%; P less than .001).
 

Closure vs. medical therapy alone

Finally, in the third paper, Jeffrey L. Saver, MD, of the University of California, Los Angeles, and his associates reported the long-term outcomes of the RESPECT trial of PFO closure versus medical therapy alone in 980 patients with PFO who had experienced a cryptogenic ischemic stroke (N Engl J Med. 2017; 377:1022-32).

After a median follow-up of 5.9 years, there was a 45% lower risk of recurrent ischemic stroke in the closure group, compared with the medical therapy alone group. The overall incidence of recurrent ischemic stroke was 0.58 events per 100 patient-years after closure, compared against 1.07 events with medical therapy, which included aspirin, warfarin, clopidogrel, or aspirin combined with extended-release dipyridamole.

However, the rate of pulmonary embolism was more than threefold higher, and the rate of deep vein thrombosis was more than fourfold higher in the closure group, compared with the medical therapy group, although the latter was not statistically significant.
 

FDA perspective

In an accompanying perspective on the three studies, Andrew Farb, MD, and his colleagues from the Center for Devices and Radiological Health at the Food and Drug Administration noted that the clinical benefit of closing a PFO has been an ongoing question for several decades, but the data on the Amplatzer PFO Occluder – a device for PFO closure – had met the agency’s approval threshold.

“The FDA concluded that although there were few recurrent strokes in both groups and some uncertainty regarding the reduction in stroke risk attributable to the device, preventing recurrent stroke is of high value,” the authors wrote (N Engl J Med. 2017;377:1006-9).

However, they stressed that because of the high prevalence of PFO, patients being considered for surgical closure should undergo comprehensive clinical assessment by a neurologist and cardiologist to ensure the ischemic stroke did not have any other possible cause.

The CLOSE trial was supported by the French Ministry of Health. Fourteen authors reported funding, grants, consultancies, and other support from the pharmaceutical industry. The REDUCE trial was supported by W.L. Gore and Associates, and 11 authors declared grants or fees from W.L. Gore and Associates. The RESPECT trial was supported by St. Jude Medical. Eight authors declared grants, fees, or nonfinancial support from St. Jude Medical. One also declared grants and fees from the pharmaceutical industry. The authors of the accompanying perspective had no conflicts of interest to declare.

[email protected]

Three separate trials examining the impact of closing a patent foramen ovale on the risk of stroke all point to endovascular closure offering a greater reduction in risk than with anticoagulant or antiplatelet therapy alone.

However, this benefit may be evident only in patients at higher risk of stroke associated with patent foramen ovale (PFO), and comes at the cost of an increased risk of atrial fibrillation and procedure-related adverse events, according to papers published in the Sept. 14 issue of the New England Journal of Medicine.
 

Closure plus anticoagulation vs. anticoagulation or antiplatelets alone

In the CLOSE trial, 663 patients aged 16-60 years who had experienced a recent stroke attributed to PFO and who had an associated atrial septal aneurysm or large interatrial shunt were randomized to transcatheter closure plus long-term antiplatelet therapy, antiplatelets alone, or oral anticoagulation alone.

After a mean follow-up of 5.3 years, Jean‑Louis Mas, MD, of Sainte-Anne Hospital, Paris, and his colleagues reported that there were no recurrent strokes in the closure group, but 14 of the 235 patients in the antiplatelets-only group experienced a stroke, representing a 97% reduction in the risk of stroke with endovascular closure (P less than .001). Patients in the antiplatelets-only group had a 4.9% overall probability of stroke, and no explanation other than PFO could be found for their recurrent stroke (N Engl J Med. 2017;377:1011-21), reported .

The study was not adequately powered to compare the outcomes of anticoagulant therapy with antiplatelet therapy alone.

The closure group also had a 61% lower risk of the secondary composite outcome of stroke, transient ischemic attack, or systemic embolism, compared with the antiplatelet-only group (P = .01).

However, closure of the PFO was associated with a higher rate of new-onset atrial fibrillation or flutter than antiplatelet therapy alone (4.6% vs. 0.9%, P = .02), and major procedural complications occurred in 5.9% of patients.
 

Closure plus antiplatelets vs. antiplatelets alone

In the second study – REDUCE – 664 patients with PFO who had experienced an ischemic stroke with no other obvious cause were randomized either to closure plus antiplatelet therapy or antiplatelet therapy alone (N Engl J Med. 2017;377:1033-42).

Over the median follow-up of 3.2 years, there were ischemic strokes in 1.4% of patients in the closure group, compared with 5.4% in the antiplatelet-only group; this was a 77% reduction in risk (P = .002), Lars Søndergaard, MD, of the University of Copenhagen, and his coauthors reported.

The closure group also had a 49% lower incidence of new brain infarctions, compared with the antiplatelet-only group, although the incidence of silent brain infarction was similar between the two groups.

While the risks of major bleeding, deep-vein thrombosis, and pulmonary embolism and serious adverse events were similar between the two groups, the closure group had a 2.5% rate of procedure-related serious adverse events and 1.4% rate of device-related serious adverse events. The closure group also had a significantly higher incidence of atrial fibrillation when compared with the control group (6.6% vs. 0.4%; P less than .001).
 

Closure vs. medical therapy alone

Finally, in the third paper, Jeffrey L. Saver, MD, of the University of California, Los Angeles, and his associates reported the long-term outcomes of the RESPECT trial of PFO closure versus medical therapy alone in 980 patients with PFO who had experienced a cryptogenic ischemic stroke (N Engl J Med. 2017; 377:1022-32).

After a median follow-up of 5.9 years, there was a 45% lower risk of recurrent ischemic stroke in the closure group, compared with the medical therapy alone group. The overall incidence of recurrent ischemic stroke was 0.58 events per 100 patient-years after closure, compared against 1.07 events with medical therapy, which included aspirin, warfarin, clopidogrel, or aspirin combined with extended-release dipyridamole.

However, the rate of pulmonary embolism was more than threefold higher, and the rate of deep vein thrombosis was more than fourfold higher in the closure group, compared with the medical therapy group, although the latter was not statistically significant.
 

FDA perspective

In an accompanying perspective on the three studies, Andrew Farb, MD, and his colleagues from the Center for Devices and Radiological Health at the Food and Drug Administration noted that the clinical benefit of closing a PFO has been an ongoing question for several decades, but the data on the Amplatzer PFO Occluder – a device for PFO closure – had met the agency’s approval threshold.

“The FDA concluded that although there were few recurrent strokes in both groups and some uncertainty regarding the reduction in stroke risk attributable to the device, preventing recurrent stroke is of high value,” the authors wrote (N Engl J Med. 2017;377:1006-9).

However, they stressed that because of the high prevalence of PFO, patients being considered for surgical closure should undergo comprehensive clinical assessment by a neurologist and cardiologist to ensure the ischemic stroke did not have any other possible cause.

The CLOSE trial was supported by the French Ministry of Health. Fourteen authors reported funding, grants, consultancies, and other support from the pharmaceutical industry. The REDUCE trial was supported by W.L. Gore and Associates, and 11 authors declared grants or fees from W.L. Gore and Associates. The RESPECT trial was supported by St. Jude Medical. Eight authors declared grants, fees, or nonfinancial support from St. Jude Medical. One also declared grants and fees from the pharmaceutical industry. The authors of the accompanying perspective had no conflicts of interest to declare.

[email protected]

Three separate trials examining the impact of closing a patent foramen ovale on the risk of stroke all point to endovascular closure offering a greater reduction in risk than with anticoagulant or antiplatelet therapy alone.

However, this benefit may be evident only in patients at higher risk of stroke associated with patent foramen ovale (PFO), and comes at the cost of an increased risk of atrial fibrillation and procedure-related adverse events, according to papers published in the Sept. 14 issue of the New England Journal of Medicine.
 

Closure plus anticoagulation vs. anticoagulation or antiplatelets alone

In the CLOSE trial, 663 patients aged 16-60 years who had experienced a recent stroke attributed to PFO and who had an associated atrial septal aneurysm or large interatrial shunt were randomized to transcatheter closure plus long-term antiplatelet therapy, antiplatelets alone, or oral anticoagulation alone.

After a mean follow-up of 5.3 years, Jean‑Louis Mas, MD, of Sainte-Anne Hospital, Paris, and his colleagues reported that there were no recurrent strokes in the closure group, but 14 of the 235 patients in the antiplatelets-only group experienced a stroke, representing a 97% reduction in the risk of stroke with endovascular closure (P less than .001). Patients in the antiplatelets-only group had a 4.9% overall probability of stroke, and no explanation other than PFO could be found for their recurrent stroke (N Engl J Med. 2017;377:1011-21), reported .

The study was not adequately powered to compare the outcomes of anticoagulant therapy with antiplatelet therapy alone.

The closure group also had a 61% lower risk of the secondary composite outcome of stroke, transient ischemic attack, or systemic embolism, compared with the antiplatelet-only group (P = .01).

However, closure of the PFO was associated with a higher rate of new-onset atrial fibrillation or flutter than antiplatelet therapy alone (4.6% vs. 0.9%, P = .02), and major procedural complications occurred in 5.9% of patients.
 

Closure plus antiplatelets vs. antiplatelets alone

In the second study – REDUCE – 664 patients with PFO who had experienced an ischemic stroke with no other obvious cause were randomized either to closure plus antiplatelet therapy or antiplatelet therapy alone (N Engl J Med. 2017;377:1033-42).

Over the median follow-up of 3.2 years, there were ischemic strokes in 1.4% of patients in the closure group, compared with 5.4% in the antiplatelet-only group; this was a 77% reduction in risk (P = .002), Lars Søndergaard, MD, of the University of Copenhagen, and his coauthors reported.

The closure group also had a 49% lower incidence of new brain infarctions, compared with the antiplatelet-only group, although the incidence of silent brain infarction was similar between the two groups.

While the risks of major bleeding, deep-vein thrombosis, and pulmonary embolism and serious adverse events were similar between the two groups, the closure group had a 2.5% rate of procedure-related serious adverse events and 1.4% rate of device-related serious adverse events. The closure group also had a significantly higher incidence of atrial fibrillation when compared with the control group (6.6% vs. 0.4%; P less than .001).
 

Closure vs. medical therapy alone

Finally, in the third paper, Jeffrey L. Saver, MD, of the University of California, Los Angeles, and his associates reported the long-term outcomes of the RESPECT trial of PFO closure versus medical therapy alone in 980 patients with PFO who had experienced a cryptogenic ischemic stroke (N Engl J Med. 2017; 377:1022-32).

After a median follow-up of 5.9 years, there was a 45% lower risk of recurrent ischemic stroke in the closure group, compared with the medical therapy alone group. The overall incidence of recurrent ischemic stroke was 0.58 events per 100 patient-years after closure, compared against 1.07 events with medical therapy, which included aspirin, warfarin, clopidogrel, or aspirin combined with extended-release dipyridamole.

However, the rate of pulmonary embolism was more than threefold higher, and the rate of deep vein thrombosis was more than fourfold higher in the closure group, compared with the medical therapy group, although the latter was not statistically significant.
 

FDA perspective

In an accompanying perspective on the three studies, Andrew Farb, MD, and his colleagues from the Center for Devices and Radiological Health at the Food and Drug Administration noted that the clinical benefit of closing a PFO has been an ongoing question for several decades, but the data on the Amplatzer PFO Occluder – a device for PFO closure – had met the agency’s approval threshold.

“The FDA concluded that although there were few recurrent strokes in both groups and some uncertainty regarding the reduction in stroke risk attributable to the device, preventing recurrent stroke is of high value,” the authors wrote (N Engl J Med. 2017;377:1006-9).

However, they stressed that because of the high prevalence of PFO, patients being considered for surgical closure should undergo comprehensive clinical assessment by a neurologist and cardiologist to ensure the ischemic stroke did not have any other possible cause.

The CLOSE trial was supported by the French Ministry of Health. Fourteen authors reported funding, grants, consultancies, and other support from the pharmaceutical industry. The REDUCE trial was supported by W.L. Gore and Associates, and 11 authors declared grants or fees from W.L. Gore and Associates. The RESPECT trial was supported by St. Jude Medical. Eight authors declared grants, fees, or nonfinancial support from St. Jude Medical. One also declared grants and fees from the pharmaceutical industry. The authors of the accompanying perspective had no conflicts of interest to declare.

[email protected]

Patients with type 2 diabetes who took once-daily exenatide did not appear to have an increase in their overall cardiovascular risk, compared with those who took placebo, a large randomized trial demonstrated.

“We did not observe any specific safety issues during our trial; there was no adverse signal with respect to heart failure, despite the higher mean heart rate in the exenatide group than in the placebo group, and events of acute pancreatitis and pancreatic cancer were rare, with similar rates in the two groups,” according to researchers led by Rury R. Holman, F.Med.Sci. Their study was published online Sept. 14 in the New England Journal of Medicine, and was presented at the annual meeting of the European Association for the Study of Diabetes.

For the trial, which was funded by Amylin Pharmaceuticals and known as the Exenatide Study of Cardiovascular Event Lowering (EXSCEL), the researchers randomly assigned 14,752 patients with type 2 diabetes at 687 sites in 35 countries to receive subcutaneous injections of extended-released exenatide at a dose of 2 mg, or matching placebo once per week, from June 18, 2010, through Sept. 16, 2015. The patients were followed for a median of 3.2 years and the main outcome of interest was the first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or stroke.

[email protected]

PRIMARY SOURCE: N Engl J Med 2017 Sept. 14. doi: 10.1056/NEJMoa1612917

Patients with type 2 diabetes who took once-daily exenatide did not appear to have an increase in their overall cardiovascular risk, compared with those who took placebo, a large randomized trial demonstrated.

“We did not observe any specific safety issues during our trial; there was no adverse signal with respect to heart failure, despite the higher mean heart rate in the exenatide group than in the placebo group, and events of acute pancreatitis and pancreatic cancer were rare, with similar rates in the two groups,” according to researchers led by Rury R. Holman, F.Med.Sci. Their study was published online Sept. 14 in the New England Journal of Medicine, and was presented at the annual meeting of the European Association for the Study of Diabetes.

For the trial, which was funded by Amylin Pharmaceuticals and known as the Exenatide Study of Cardiovascular Event Lowering (EXSCEL), the researchers randomly assigned 14,752 patients with type 2 diabetes at 687 sites in 35 countries to receive subcutaneous injections of extended-released exenatide at a dose of 2 mg, or matching placebo once per week, from June 18, 2010, through Sept. 16, 2015. The patients were followed for a median of 3.2 years and the main outcome of interest was the first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or stroke.

[email protected]

PRIMARY SOURCE: N Engl J Med 2017 Sept. 14. doi: 10.1056/NEJMoa1612917

Patients with type 2 diabetes who took once-daily exenatide did not appear to have an increase in their overall cardiovascular risk, compared with those who took placebo, a large randomized trial demonstrated.

“We did not observe any specific safety issues during our trial; there was no adverse signal with respect to heart failure, despite the higher mean heart rate in the exenatide group than in the placebo group, and events of acute pancreatitis and pancreatic cancer were rare, with similar rates in the two groups,” according to researchers led by Rury R. Holman, F.Med.Sci. Their study was published online Sept. 14 in the New England Journal of Medicine, and was presented at the annual meeting of the European Association for the Study of Diabetes.

For the trial, which was funded by Amylin Pharmaceuticals and known as the Exenatide Study of Cardiovascular Event Lowering (EXSCEL), the researchers randomly assigned 14,752 patients with type 2 diabetes at 687 sites in 35 countries to receive subcutaneous injections of extended-released exenatide at a dose of 2 mg, or matching placebo once per week, from June 18, 2010, through Sept. 16, 2015. The patients were followed for a median of 3.2 years and the main outcome of interest was the first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or stroke.

[email protected]

PRIMARY SOURCE: N Engl J Med 2017 Sept. 14. doi: 10.1056/NEJMoa1612917

A recent increase in the death rate from stroke resulted in more than 32,000 more deaths than would have occurred had the previous long-term decline continued, according to the Centers for Disease Control and Prevention.

The overall age-standardized stroke death rate among adults aged 35 years and older declined from 118.4 per 100,000 in 2000 to 73.3 per 100,000 in 2015, for an average annual percent change of –3.1%. That long-term rate, however, includes a more recent, but statistically nonsignificant, increase of 2.5% a year in 2013-2015, which produced an estimated 32,593 excess deaths based on the previous rate of decline, the CDC investigators said (MMWR 2017 Sep 6;66[early release]:1-7).

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A recent increase in the death rate from stroke resulted in more than 32,000 more deaths than would have occurred had the previous long-term decline continued, according to the Centers for Disease Control and Prevention.

The overall age-standardized stroke death rate among adults aged 35 years and older declined from 118.4 per 100,000 in 2000 to 73.3 per 100,000 in 2015, for an average annual percent change of –3.1%. That long-term rate, however, includes a more recent, but statistically nonsignificant, increase of 2.5% a year in 2013-2015, which produced an estimated 32,593 excess deaths based on the previous rate of decline, the CDC investigators said (MMWR 2017 Sep 6;66[early release]:1-7).

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A recent increase in the death rate from stroke resulted in more than 32,000 more deaths than would have occurred had the previous long-term decline continued, according to the Centers for Disease Control and Prevention.

The overall age-standardized stroke death rate among adults aged 35 years and older declined from 118.4 per 100,000 in 2000 to 73.3 per 100,000 in 2015, for an average annual percent change of –3.1%. That long-term rate, however, includes a more recent, but statistically nonsignificant, increase of 2.5% a year in 2013-2015, which produced an estimated 32,593 excess deaths based on the previous rate of decline, the CDC investigators said (MMWR 2017 Sep 6;66[early release]:1-7).

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Over an 18-month period, small, insertable cardiac monitors detected atrial fibrillation in 29% of previously undiagnosed patients who were at high risk of both AF and stroke, and in 40% of patients over 30 months, according to investigators. The study was presented at the annual congress of the European Society of Cardiology and simultaneously published in JAMA Cardiology.

More than half (56%) of patients consequently started oral anticoagulation therapy, noted James A. Reiffel, MD, of Columbia University College of Physicians and Surgeons, New York, with his associates, for the REVEAL AF investigators.

“The incidence of previously undiagnosed atrial fibrillation may be substantial in patients with risk factors for AF and stroke,” they concluded. “Atrial fibrillation would have gone undetected in most patients had monitoring been limited to 30 days. Further trials regarding the value of detecting subclinical AF and of prophylactic therapies are warranted.”

Atrial fibrillation affects millions worldwide and is associated with older age, hypertension, diabetes, and heart failure, all of which also independently increase the risk of stroke. Minimally invasive prolonged electrocardiographic monitoring with insertable cardiac monitors might help hasten detection and treatment of AF, but diagnostic yield in high-risk patients has been unclear.

In this single-arm, multicenter, prospective study, researchers inserted Reveal XT or Reveal LINQ (Medtronic) cardiac monitors in 385 adults who had either CHAD2 scores of 3, or CHAD2 scores of 2 and one additional risk factor for AF, such as coronary artery disease, sleep apnea, chronic obstructive pulmonary disease, or renal insufficiency. The primary endpoint was AF lasting at least 6 minutes (JAMA Cardiol. 2017 Aug 26. doi: 10.1001/jamacardio.2017.3180). Median follow-up time was 22.5 months. Rates of detecting AF were 6% at 30 days compared with 20% at 6 months, 27% at 12 months, 34% at 24 months, and 40% at 30 months. Patients typically had their first AF episode about 4 months (median, 123 days) after the device was inserted. Among patients who had experienced AF by 18 months, 10% had one or more episodes lasting at least 24 hours, and 72 (56%) were prescribed oral anticoagulation therapy.

The recent PREDATE AF and ASSERT-II studies also found that previously undiagnosed AF was common among high-risk patients, the researchers noted. However, whether anticoagulating patients who have only brief episodes of AF significantly reduces their risk of stroke remains unclear, they added. Three trials (ARTESiA, NOAH, and LOOP) are underway to assess whether oral anticoagulation therapy improves outcomes in patients with device-detected AF.

Medtronic funded the study. Dr. Reiffel and five coinvestigators disclosed consulting for and receiving “modest honoraria” from Medtronic. Two other coinvestigators reported employment with and stock ownership in Medtronic.

Over an 18-month period, small, insertable cardiac monitors detected atrial fibrillation in 29% of previously undiagnosed patients who were at high risk of both AF and stroke, and in 40% of patients over 30 months, according to investigators. The study was presented at the annual congress of the European Society of Cardiology and simultaneously published in JAMA Cardiology.

More than half (56%) of patients consequently started oral anticoagulation therapy, noted James A. Reiffel, MD, of Columbia University College of Physicians and Surgeons, New York, with his associates, for the REVEAL AF investigators.

“The incidence of previously undiagnosed atrial fibrillation may be substantial in patients with risk factors for AF and stroke,” they concluded. “Atrial fibrillation would have gone undetected in most patients had monitoring been limited to 30 days. Further trials regarding the value of detecting subclinical AF and of prophylactic therapies are warranted.”

Atrial fibrillation affects millions worldwide and is associated with older age, hypertension, diabetes, and heart failure, all of which also independently increase the risk of stroke. Minimally invasive prolonged electrocardiographic monitoring with insertable cardiac monitors might help hasten detection and treatment of AF, but diagnostic yield in high-risk patients has been unclear.

In this single-arm, multicenter, prospective study, researchers inserted Reveal XT or Reveal LINQ (Medtronic) cardiac monitors in 385 adults who had either CHAD2 scores of 3, or CHAD2 scores of 2 and one additional risk factor for AF, such as coronary artery disease, sleep apnea, chronic obstructive pulmonary disease, or renal insufficiency. The primary endpoint was AF lasting at least 6 minutes (JAMA Cardiol. 2017 Aug 26. doi: 10.1001/jamacardio.2017.3180). Median follow-up time was 22.5 months. Rates of detecting AF were 6% at 30 days compared with 20% at 6 months, 27% at 12 months, 34% at 24 months, and 40% at 30 months. Patients typically had their first AF episode about 4 months (median, 123 days) after the device was inserted. Among patients who had experienced AF by 18 months, 10% had one or more episodes lasting at least 24 hours, and 72 (56%) were prescribed oral anticoagulation therapy.

The recent PREDATE AF and ASSERT-II studies also found that previously undiagnosed AF was common among high-risk patients, the researchers noted. However, whether anticoagulating patients who have only brief episodes of AF significantly reduces their risk of stroke remains unclear, they added. Three trials (ARTESiA, NOAH, and LOOP) are underway to assess whether oral anticoagulation therapy improves outcomes in patients with device-detected AF.

Medtronic funded the study. Dr. Reiffel and five coinvestigators disclosed consulting for and receiving “modest honoraria” from Medtronic. Two other coinvestigators reported employment with and stock ownership in Medtronic.

Over an 18-month period, small, insertable cardiac monitors detected atrial fibrillation in 29% of previously undiagnosed patients who were at high risk of both AF and stroke, and in 40% of patients over 30 months, according to investigators. The study was presented at the annual congress of the European Society of Cardiology and simultaneously published in JAMA Cardiology.

More than half (56%) of patients consequently started oral anticoagulation therapy, noted James A. Reiffel, MD, of Columbia University College of Physicians and Surgeons, New York, with his associates, for the REVEAL AF investigators.

“The incidence of previously undiagnosed atrial fibrillation may be substantial in patients with risk factors for AF and stroke,” they concluded. “Atrial fibrillation would have gone undetected in most patients had monitoring been limited to 30 days. Further trials regarding the value of detecting subclinical AF and of prophylactic therapies are warranted.”

Atrial fibrillation affects millions worldwide and is associated with older age, hypertension, diabetes, and heart failure, all of which also independently increase the risk of stroke. Minimally invasive prolonged electrocardiographic monitoring with insertable cardiac monitors might help hasten detection and treatment of AF, but diagnostic yield in high-risk patients has been unclear.

In this single-arm, multicenter, prospective study, researchers inserted Reveal XT or Reveal LINQ (Medtronic) cardiac monitors in 385 adults who had either CHAD2 scores of 3, or CHAD2 scores of 2 and one additional risk factor for AF, such as coronary artery disease, sleep apnea, chronic obstructive pulmonary disease, or renal insufficiency. The primary endpoint was AF lasting at least 6 minutes (JAMA Cardiol. 2017 Aug 26. doi: 10.1001/jamacardio.2017.3180). Median follow-up time was 22.5 months. Rates of detecting AF were 6% at 30 days compared with 20% at 6 months, 27% at 12 months, 34% at 24 months, and 40% at 30 months. Patients typically had their first AF episode about 4 months (median, 123 days) after the device was inserted. Among patients who had experienced AF by 18 months, 10% had one or more episodes lasting at least 24 hours, and 72 (56%) were prescribed oral anticoagulation therapy.

The recent PREDATE AF and ASSERT-II studies also found that previously undiagnosed AF was common among high-risk patients, the researchers noted. However, whether anticoagulating patients who have only brief episodes of AF significantly reduces their risk of stroke remains unclear, they added. Three trials (ARTESiA, NOAH, and LOOP) are underway to assess whether oral anticoagulation therapy improves outcomes in patients with device-detected AF.

Medtronic funded the study. Dr. Reiffel and five coinvestigators disclosed consulting for and receiving “modest honoraria” from Medtronic. Two other coinvestigators reported employment with and stock ownership in Medtronic.

Paris – A history of pregnancy did not protect against adverse outcomes at 1 year in the Women’s International Transcatheter Aortic Valve Implantation Registry (WIN-TAVI), even though it did within the first 30 days, Alaide Chieffo, MD, reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

One year ago, at EuroPCR 2016, she reported that in WIN-TAVI, a history of pregnancy – albeit typically more than half a century previously – was independently associated with a 43% reduction in the Valve Academic Research Consortium-2 (VARC-2) 30-day composite endpoint, including death, stroke, major vascular complications, life-threatening bleeding, stage 2 or 3 acute kidney injury, coronary artery obstruction, or repeat transcatheter aortic valve replacement (TAVR) done because of valve-related dysfunction. Those early findings, first reported in this publication, were later published (JACC Cardiovasc Interv. 2016 Aug 8;9[15]:1589-600).

At 1 year of follow-up, however, the rate of the VARC-2 composite endpoint was no longer significantly different in women with or without a history of pregnancy. Nor was a history of pregnancy associated with a significantly reduced risk of the secondary endpoint of death or stroke: The 27% reduction in risk of this secondary endpoint in women with a history of pregnancy, compared with that of nulliparous women, didn’t achieve statistical significance in multivariate analysis, according to Dr. Chieffo of the San Raffaele Scientific Institute in Milan.

She speculated that pregnancy earlier in life provided strong protection against poor 30-day outcomes and a similar trend – albeit not statistically significant – at 1 year because women without children may have less family support.

“They are old women, left alone, without the family taking care of them. This is socially important, I think, because we are investing quite a lot of money in a procedure, and then maybe we’re adding adverse events because these patients are not properly taken care of when they are out of the hospital,” the interventional cardiologist said.

Neither of the other two female-specific characteristics evaluated in WIN-TAVI – having a history of osteoporosis or age at menopause – turned out to be related to the risk of bad outcomes at 1 year, she added.

WIN-TAVI is the first all-female registry of patients undergoing TAVR for severe aortic stenosis. The prospective, observational registry includes 1,019 women treated at 19 highly experienced European and North American TAVR centers. They averaged 82.5 years of age with a mean Society of Thoracic Surgeons score of 8.3%, putting them at intermediate or high surgical risk. A percutaneous transfemoral approach was used in 91% of cases. TAVR was performed under conscious sedation in 28% of the women and under local anesthesia in another 37%. Of the women in the registry, 42% received a newer-generation device.

In addition to the lack of significant impact of prior pregnancy on 1-year outcomes, another noteworthy finding at 1 year of follow-up was that preprocedural atrial fibrillation was independently associated with a 58% increase in the risk of death or stroke (P = .02). Prior percutaneous coronary intervention and EuroSCORE (European System for Cardiac Operative Risk Evaluation) were the only other independent predictors.

This observation suggests the need for a women-only randomized trial of TAVR versus surgical aortic valve replacement in women with intermediate surgical risk, Dr. Chieffo suggested. It will be important to learn whether the ability to surgically ablate preoperative atrial fibrillation in women during surgical valve replacement results in a lower 1-year risk of death or stroke than is achieved with TAVR.

Overall, the 1-year clinical outcomes seen in WIN-TAVI are “very good,” she noted. The VARC-2 composite endpoint occurred in 16.5% of women, all-cause mortality in 12.5%, cardiovascular mortality in 10.8%, and stroke in 2.2%. Only 3.2% of women were hospitalized for heart failure or valve-related symptoms. A new pacemaker was implanted in 12.7% of participants. At baseline 74% of women were New York Heart Association functional class III or IV; at 1 year, only 8.1% were. Moderate paravalvular aortic regurgitation was present in 6% of patients at 6 months and in 9.7% at 1 year

The WIN-TAVI registry is entirely self-funded. Dr. Chieffo reported having no financial conflicts regarding her presentation.

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Paris – A history of pregnancy did not protect against adverse outcomes at 1 year in the Women’s International Transcatheter Aortic Valve Implantation Registry (WIN-TAVI), even though it did within the first 30 days, Alaide Chieffo, MD, reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

One year ago, at EuroPCR 2016, she reported that in WIN-TAVI, a history of pregnancy – albeit typically more than half a century previously – was independently associated with a 43% reduction in the Valve Academic Research Consortium-2 (VARC-2) 30-day composite endpoint, including death, stroke, major vascular complications, life-threatening bleeding, stage 2 or 3 acute kidney injury, coronary artery obstruction, or repeat transcatheter aortic valve replacement (TAVR) done because of valve-related dysfunction. Those early findings, first reported in this publication, were later published (JACC Cardiovasc Interv. 2016 Aug 8;9[15]:1589-600).

At 1 year of follow-up, however, the rate of the VARC-2 composite endpoint was no longer significantly different in women with or without a history of pregnancy. Nor was a history of pregnancy associated with a significantly reduced risk of the secondary endpoint of death or stroke: The 27% reduction in risk of this secondary endpoint in women with a history of pregnancy, compared with that of nulliparous women, didn’t achieve statistical significance in multivariate analysis, according to Dr. Chieffo of the San Raffaele Scientific Institute in Milan.

She speculated that pregnancy earlier in life provided strong protection against poor 30-day outcomes and a similar trend – albeit not statistically significant – at 1 year because women without children may have less family support.

“They are old women, left alone, without the family taking care of them. This is socially important, I think, because we are investing quite a lot of money in a procedure, and then maybe we’re adding adverse events because these patients are not properly taken care of when they are out of the hospital,” the interventional cardiologist said.

Neither of the other two female-specific characteristics evaluated in WIN-TAVI – having a history of osteoporosis or age at menopause – turned out to be related to the risk of bad outcomes at 1 year, she added.

WIN-TAVI is the first all-female registry of patients undergoing TAVR for severe aortic stenosis. The prospective, observational registry includes 1,019 women treated at 19 highly experienced European and North American TAVR centers. They averaged 82.5 years of age with a mean Society of Thoracic Surgeons score of 8.3%, putting them at intermediate or high surgical risk. A percutaneous transfemoral approach was used in 91% of cases. TAVR was performed under conscious sedation in 28% of the women and under local anesthesia in another 37%. Of the women in the registry, 42% received a newer-generation device.

In addition to the lack of significant impact of prior pregnancy on 1-year outcomes, another noteworthy finding at 1 year of follow-up was that preprocedural atrial fibrillation was independently associated with a 58% increase in the risk of death or stroke (P = .02). Prior percutaneous coronary intervention and EuroSCORE (European System for Cardiac Operative Risk Evaluation) were the only other independent predictors.

This observation suggests the need for a women-only randomized trial of TAVR versus surgical aortic valve replacement in women with intermediate surgical risk, Dr. Chieffo suggested. It will be important to learn whether the ability to surgically ablate preoperative atrial fibrillation in women during surgical valve replacement results in a lower 1-year risk of death or stroke than is achieved with TAVR.

Overall, the 1-year clinical outcomes seen in WIN-TAVI are “very good,” she noted. The VARC-2 composite endpoint occurred in 16.5% of women, all-cause mortality in 12.5%, cardiovascular mortality in 10.8%, and stroke in 2.2%. Only 3.2% of women were hospitalized for heart failure or valve-related symptoms. A new pacemaker was implanted in 12.7% of participants. At baseline 74% of women were New York Heart Association functional class III or IV; at 1 year, only 8.1% were. Moderate paravalvular aortic regurgitation was present in 6% of patients at 6 months and in 9.7% at 1 year

The WIN-TAVI registry is entirely self-funded. Dr. Chieffo reported having no financial conflicts regarding her presentation.

[email protected]

Paris – A history of pregnancy did not protect against adverse outcomes at 1 year in the Women’s International Transcatheter Aortic Valve Implantation Registry (WIN-TAVI), even though it did within the first 30 days, Alaide Chieffo, MD, reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

One year ago, at EuroPCR 2016, she reported that in WIN-TAVI, a history of pregnancy – albeit typically more than half a century previously – was independently associated with a 43% reduction in the Valve Academic Research Consortium-2 (VARC-2) 30-day composite endpoint, including death, stroke, major vascular complications, life-threatening bleeding, stage 2 or 3 acute kidney injury, coronary artery obstruction, or repeat transcatheter aortic valve replacement (TAVR) done because of valve-related dysfunction. Those early findings, first reported in this publication, were later published (JACC Cardiovasc Interv. 2016 Aug 8;9[15]:1589-600).

At 1 year of follow-up, however, the rate of the VARC-2 composite endpoint was no longer significantly different in women with or without a history of pregnancy. Nor was a history of pregnancy associated with a significantly reduced risk of the secondary endpoint of death or stroke: The 27% reduction in risk of this secondary endpoint in women with a history of pregnancy, compared with that of nulliparous women, didn’t achieve statistical significance in multivariate analysis, according to Dr. Chieffo of the San Raffaele Scientific Institute in Milan.

She speculated that pregnancy earlier in life provided strong protection against poor 30-day outcomes and a similar trend – albeit not statistically significant – at 1 year because women without children may have less family support.

“They are old women, left alone, without the family taking care of them. This is socially important, I think, because we are investing quite a lot of money in a procedure, and then maybe we’re adding adverse events because these patients are not properly taken care of when they are out of the hospital,” the interventional cardiologist said.

Neither of the other two female-specific characteristics evaluated in WIN-TAVI – having a history of osteoporosis or age at menopause – turned out to be related to the risk of bad outcomes at 1 year, she added.

WIN-TAVI is the first all-female registry of patients undergoing TAVR for severe aortic stenosis. The prospective, observational registry includes 1,019 women treated at 19 highly experienced European and North American TAVR centers. They averaged 82.5 years of age with a mean Society of Thoracic Surgeons score of 8.3%, putting them at intermediate or high surgical risk. A percutaneous transfemoral approach was used in 91% of cases. TAVR was performed under conscious sedation in 28% of the women and under local anesthesia in another 37%. Of the women in the registry, 42% received a newer-generation device.

In addition to the lack of significant impact of prior pregnancy on 1-year outcomes, another noteworthy finding at 1 year of follow-up was that preprocedural atrial fibrillation was independently associated with a 58% increase in the risk of death or stroke (P = .02). Prior percutaneous coronary intervention and EuroSCORE (European System for Cardiac Operative Risk Evaluation) were the only other independent predictors.

This observation suggests the need for a women-only randomized trial of TAVR versus surgical aortic valve replacement in women with intermediate surgical risk, Dr. Chieffo suggested. It will be important to learn whether the ability to surgically ablate preoperative atrial fibrillation in women during surgical valve replacement results in a lower 1-year risk of death or stroke than is achieved with TAVR.

Overall, the 1-year clinical outcomes seen in WIN-TAVI are “very good,” she noted. The VARC-2 composite endpoint occurred in 16.5% of women, all-cause mortality in 12.5%, cardiovascular mortality in 10.8%, and stroke in 2.2%. Only 3.2% of women were hospitalized for heart failure or valve-related symptoms. A new pacemaker was implanted in 12.7% of participants. At baseline 74% of women were New York Heart Association functional class III or IV; at 1 year, only 8.1% were. Moderate paravalvular aortic regurgitation was present in 6% of patients at 6 months and in 9.7% at 1 year

The WIN-TAVI registry is entirely self-funded. Dr. Chieffo reported having no financial conflicts regarding her presentation.

[email protected]