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Mitchel is a reporter for MDedge based in the Philadelphia area. He started with the company in 1992, when it was International Medical News Group (IMNG), and has since covered a range of medical specialties. Mitchel trained as a virologist at Roswell Park Memorial Institute in Buffalo, and then worked briefly as a researcher at Boston Children's Hospital before pivoting to journalism as a AAAS Mass Media Fellow in 1980. His first reporting job was with Science Digest magazine, and from the mid-1980s to early-1990s he was a reporter with Medical World News. @mitchelzoler
Percutaneous procedure gives alternative to anticoagulation for portal vein thrombosis
WASHINGTON – Catheter-directed clot lysis and thrombectomy with creation of a bypass shunt is a reasonable alternative to prolonged anticoagulation for treating patients with portal vein thrombosis (PVT) based on the accumulated reported experience since 1993 using this percutaneous treatment.
” Nelson Valentin, MD, said at the annual Digestive Disease Week.® “TIPS should be considered a viable treatment option for patients with PVT,” said Dr. Valentin, a gastroenterology fellow at Mount Sinai Beth Israel hospital in New York.
“There is sufficient evidence from these reports to at least consider TIPS as an adjunct to anticoagulation or perhaps as primary therapy,” especially for patients with PVT who have a contraindication for anticoagulation, Dr. Valentin said in an interview. Standard anticoagulation for PVT would today involve acute treatment with a low-molecular-weight heparin followed by oral anticoagulation for a total treatment time of at least 6 months and continued for a year or longer in some patients. A recently published review of reported experience using anticoagulation to treat PVT found a complete recanalization rate of 41% and a complete or partial rate of 66%, which suggests that TIPS is at least as effective, although Dr. Valentin cautioned that no reported study has directly compared the two alternative approaches. A study designed to make this direct comparison is warranted by the reported results using TIPS, Dr. Valentin said. And the experience with TIPS positions it as an option for patients who do not respond to anticoagulation or would prefer an alternative to prolonged anticoagulation.
One factor currently limiting use of TIPS, which is usually performed by an interventional radiologist, is that the procedure is technically demanding, with a limited number of operators with the expertise to perform it. If TIPS became more widely accepted as an option for treating PVT, then the pool of interventionalists experienced with performing the procedure would grow, Dr. Valentin noted.
[email protected]
On Twitter @mitchelzoler
SOURCE: Valentin N et al. Digestive Disease Week, Presentation 361.
WASHINGTON – Catheter-directed clot lysis and thrombectomy with creation of a bypass shunt is a reasonable alternative to prolonged anticoagulation for treating patients with portal vein thrombosis (PVT) based on the accumulated reported experience since 1993 using this percutaneous treatment.
” Nelson Valentin, MD, said at the annual Digestive Disease Week.® “TIPS should be considered a viable treatment option for patients with PVT,” said Dr. Valentin, a gastroenterology fellow at Mount Sinai Beth Israel hospital in New York.
“There is sufficient evidence from these reports to at least consider TIPS as an adjunct to anticoagulation or perhaps as primary therapy,” especially for patients with PVT who have a contraindication for anticoagulation, Dr. Valentin said in an interview. Standard anticoagulation for PVT would today involve acute treatment with a low-molecular-weight heparin followed by oral anticoagulation for a total treatment time of at least 6 months and continued for a year or longer in some patients. A recently published review of reported experience using anticoagulation to treat PVT found a complete recanalization rate of 41% and a complete or partial rate of 66%, which suggests that TIPS is at least as effective, although Dr. Valentin cautioned that no reported study has directly compared the two alternative approaches. A study designed to make this direct comparison is warranted by the reported results using TIPS, Dr. Valentin said. And the experience with TIPS positions it as an option for patients who do not respond to anticoagulation or would prefer an alternative to prolonged anticoagulation.
One factor currently limiting use of TIPS, which is usually performed by an interventional radiologist, is that the procedure is technically demanding, with a limited number of operators with the expertise to perform it. If TIPS became more widely accepted as an option for treating PVT, then the pool of interventionalists experienced with performing the procedure would grow, Dr. Valentin noted.
[email protected]
On Twitter @mitchelzoler
SOURCE: Valentin N et al. Digestive Disease Week, Presentation 361.
WASHINGTON – Catheter-directed clot lysis and thrombectomy with creation of a bypass shunt is a reasonable alternative to prolonged anticoagulation for treating patients with portal vein thrombosis (PVT) based on the accumulated reported experience since 1993 using this percutaneous treatment.
” Nelson Valentin, MD, said at the annual Digestive Disease Week.® “TIPS should be considered a viable treatment option for patients with PVT,” said Dr. Valentin, a gastroenterology fellow at Mount Sinai Beth Israel hospital in New York.
“There is sufficient evidence from these reports to at least consider TIPS as an adjunct to anticoagulation or perhaps as primary therapy,” especially for patients with PVT who have a contraindication for anticoagulation, Dr. Valentin said in an interview. Standard anticoagulation for PVT would today involve acute treatment with a low-molecular-weight heparin followed by oral anticoagulation for a total treatment time of at least 6 months and continued for a year or longer in some patients. A recently published review of reported experience using anticoagulation to treat PVT found a complete recanalization rate of 41% and a complete or partial rate of 66%, which suggests that TIPS is at least as effective, although Dr. Valentin cautioned that no reported study has directly compared the two alternative approaches. A study designed to make this direct comparison is warranted by the reported results using TIPS, Dr. Valentin said. And the experience with TIPS positions it as an option for patients who do not respond to anticoagulation or would prefer an alternative to prolonged anticoagulation.
One factor currently limiting use of TIPS, which is usually performed by an interventional radiologist, is that the procedure is technically demanding, with a limited number of operators with the expertise to perform it. If TIPS became more widely accepted as an option for treating PVT, then the pool of interventionalists experienced with performing the procedure would grow, Dr. Valentin noted.
[email protected]
On Twitter @mitchelzoler
SOURCE: Valentin N et al. Digestive Disease Week, Presentation 361.
REPORTING FROM DDW 2018
Key clinical point: Reported worldwide experience with TIPS in 439 patients shows it works and is relatively safe.
Major finding: TIPS was technically successful in 87% of reported patients and achieved complete portal recanalization in 74% of patients.
Study details: Systematic review of 18 published case series from 1993 to 2016 with 439 total patients.
Disclosures: Dr. Valentin had no disclosures.
Source: Valentin N et al. Digestive Disease Week, Presentation 361.
App monitoring improves quality of IBD care
WASHINGTON – in a single-center randomized study with 320 patients.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Based on this success, the app will soon be made available to all of the roughly 5,000 inflammatory bowel disease (IBD) patients managed at Mount Sinai Medical Center in New York as well as IBD patients at several other North American centers that plan to adopt the app, Ashish Atreja, MD, said at the annual Digestive Disease Week.®
Home monitoring of IBD patients “is feasible with high adoption,” said Dr. Atreja, a gastroenterologist at Mount Sinai who directs the Sinai AppLab. The 162 IBD patients randomized to regularly use the HealthPROMISE app had their quality-of-care metric rise from 50% at baseline to 84% after an average follow-up of 575 days (19 months), a statistically significant improvement over the 158 control patients whose metric rose from 50% to 65% for the study’s primary endpoint, he reported. The results also showed a trend toward improved quality of life among the patients using the HealthPROMISE app, compared with the controls, who used an IBD educational app that produced less patient engagement than did the HealthPROMISE app, Dr Atreja said.
Dr. Atreja and his associates modeled the app on remote monitoring methods developed for patients with other types of chronic disease, such as diabetes and heart failure.
“You can’t provide proactive IBD care without remote monitoring,” Dr. Atreja explained in a video interview. “Reactive care is not best practice anymore. The only way to do treat-to-target is with remote monitoring.”
Care coordinators monitor the entries that IBD patients send in via the app. Dr. Atreja estimated that about five care coordinators will be able to track the inputs from the roughly 5,000 IBD patients at Mount Sinai who will soon begin using the app. The financial feasibility of this approach depends in part on the $45/patient per month reimbursement that U.S. health insurers now provide to centers that run remote monitoring programs, he said.
“The direction for managing chronic diseases is increasingly looking at home monitoring as a way to streamline costs and improve patient care,” commented Gil Y. Melmed, MD, director of Clinical Inflammatory Bowel Disease at Cedars-Sinai Medical Center in Los Angeles. The results that Dr. Atreja reported came from “a highly selected population that was well educated and largely white.” The study needs replication in different patient groups to establish its reproducibility and generalizability, Dr. Melmed said in an interview.
Dr. Melmed had no relevant disclosures.
[email protected]
On Twitter @mitchelzoler
SOURCE: Atreja A et al. Digestive Disease Week 2018 abstract 17.
*This story was updated on June 7, 2018.
WASHINGTON – in a single-center randomized study with 320 patients.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Based on this success, the app will soon be made available to all of the roughly 5,000 inflammatory bowel disease (IBD) patients managed at Mount Sinai Medical Center in New York as well as IBD patients at several other North American centers that plan to adopt the app, Ashish Atreja, MD, said at the annual Digestive Disease Week.®
Home monitoring of IBD patients “is feasible with high adoption,” said Dr. Atreja, a gastroenterologist at Mount Sinai who directs the Sinai AppLab. The 162 IBD patients randomized to regularly use the HealthPROMISE app had their quality-of-care metric rise from 50% at baseline to 84% after an average follow-up of 575 days (19 months), a statistically significant improvement over the 158 control patients whose metric rose from 50% to 65% for the study’s primary endpoint, he reported. The results also showed a trend toward improved quality of life among the patients using the HealthPROMISE app, compared with the controls, who used an IBD educational app that produced less patient engagement than did the HealthPROMISE app, Dr Atreja said.
Dr. Atreja and his associates modeled the app on remote monitoring methods developed for patients with other types of chronic disease, such as diabetes and heart failure.
“You can’t provide proactive IBD care without remote monitoring,” Dr. Atreja explained in a video interview. “Reactive care is not best practice anymore. The only way to do treat-to-target is with remote monitoring.”
Care coordinators monitor the entries that IBD patients send in via the app. Dr. Atreja estimated that about five care coordinators will be able to track the inputs from the roughly 5,000 IBD patients at Mount Sinai who will soon begin using the app. The financial feasibility of this approach depends in part on the $45/patient per month reimbursement that U.S. health insurers now provide to centers that run remote monitoring programs, he said.
“The direction for managing chronic diseases is increasingly looking at home monitoring as a way to streamline costs and improve patient care,” commented Gil Y. Melmed, MD, director of Clinical Inflammatory Bowel Disease at Cedars-Sinai Medical Center in Los Angeles. The results that Dr. Atreja reported came from “a highly selected population that was well educated and largely white.” The study needs replication in different patient groups to establish its reproducibility and generalizability, Dr. Melmed said in an interview.
Dr. Melmed had no relevant disclosures.
[email protected]
On Twitter @mitchelzoler
SOURCE: Atreja A et al. Digestive Disease Week 2018 abstract 17.
*This story was updated on June 7, 2018.
WASHINGTON – in a single-center randomized study with 320 patients.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Based on this success, the app will soon be made available to all of the roughly 5,000 inflammatory bowel disease (IBD) patients managed at Mount Sinai Medical Center in New York as well as IBD patients at several other North American centers that plan to adopt the app, Ashish Atreja, MD, said at the annual Digestive Disease Week.®
Home monitoring of IBD patients “is feasible with high adoption,” said Dr. Atreja, a gastroenterologist at Mount Sinai who directs the Sinai AppLab. The 162 IBD patients randomized to regularly use the HealthPROMISE app had their quality-of-care metric rise from 50% at baseline to 84% after an average follow-up of 575 days (19 months), a statistically significant improvement over the 158 control patients whose metric rose from 50% to 65% for the study’s primary endpoint, he reported. The results also showed a trend toward improved quality of life among the patients using the HealthPROMISE app, compared with the controls, who used an IBD educational app that produced less patient engagement than did the HealthPROMISE app, Dr Atreja said.
Dr. Atreja and his associates modeled the app on remote monitoring methods developed for patients with other types of chronic disease, such as diabetes and heart failure.
“You can’t provide proactive IBD care without remote monitoring,” Dr. Atreja explained in a video interview. “Reactive care is not best practice anymore. The only way to do treat-to-target is with remote monitoring.”
Care coordinators monitor the entries that IBD patients send in via the app. Dr. Atreja estimated that about five care coordinators will be able to track the inputs from the roughly 5,000 IBD patients at Mount Sinai who will soon begin using the app. The financial feasibility of this approach depends in part on the $45/patient per month reimbursement that U.S. health insurers now provide to centers that run remote monitoring programs, he said.
“The direction for managing chronic diseases is increasingly looking at home monitoring as a way to streamline costs and improve patient care,” commented Gil Y. Melmed, MD, director of Clinical Inflammatory Bowel Disease at Cedars-Sinai Medical Center in Los Angeles. The results that Dr. Atreja reported came from “a highly selected population that was well educated and largely white.” The study needs replication in different patient groups to establish its reproducibility and generalizability, Dr. Melmed said in an interview.
Dr. Melmed had no relevant disclosures.
[email protected]
On Twitter @mitchelzoler
SOURCE: Atreja A et al. Digestive Disease Week 2018 abstract 17.
*This story was updated on June 7, 2018.
REPORTING FROM DDW 2018
Key clinical point: Regular remote monitoring of IBD patients improved the medical care they received.
Major finding: Quality of care rose from 50% at baseline to 84% in app-monitored patients and to 65% in controls.
Study details: A single-center randomized study with 320 IBD patients.
Disclosures: The study had no commercial funding. Dr. Atreja had no disclosures.
Source: Atreja A et al. Digestive Disease Week 2018 abstract 17.
A fib ablation in HFrEF patients gains momentum
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
BOSTON – Results from two recent trials suggest that cardiologists may have a new way to improve outcomes in patients with heart failure with reduced ejection fraction if they also have atrial fibrillation: Cut the patient’s atrial fibrillation burden with catheter ablation.
This seemingly off-target approach to improving survival, avoiding heart failure hospitalizations, and possibly reducing other adverse events first gained attention with results from the CASTLE-AF (Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF) randomized trial, first reported in 2017. The study showed in 363 patients that atrial fibrillation (AF) ablation in patients with heart failure with reduced ejection fraction (HFrEF) led to a statistically significant 38% relative reduction in the primary endpoint of mortality or heart failure hospitalization during a median 38 months of follow-up (N Engl J Med. 2018 Feb 1;378[5]:417-27).
This groundbreaking finding then received some degree of confirmation when Douglas L. Packer, MD, reported primary results from CABANA (Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial) at the annual scientific sessions of the Heart Rhythm Society. CABANA compared upfront ablation against first-line medical management of AF in 2,203 patients. While the primary endpoint of the cumulative rate of all-cause death, disabling stroke, serious bleeding, or cardiac arrest over a median follow-up of just over 4 years was neutral, with no statistically significant difference between the two treatment arms, a subgroup analysis showed a tantalizing suggestion of benefit in the 337 enrolled patients with a history of congestive heart failure (15% of the total study group).
In this subgroup, treatment with ablation cut the primary endpoint by 39% relative to those treated upfront with medical management, an effect that came close to statistical significance. In addition, Dr. Packer took special note of the per-protocol analysis, which censored out the crossover patients who constituted roughly a fifth of all enrolled patients. In the subgroup analysis using the per-protocol data, ablation was linked with a statistically significant 49% relative reduction in the primary endpoint among patients with a history of heart failure.
The patients for whom there may be the quickest shift to upfront ablation to treat AF based on the CABANA results will be those with heart failure and others with high underlying risk, Dr. Packer predicted at the meeting.
“The CASTLE-AF results were interesting, but in fewer than 400 patients. Now we’ve basically seen the same thing” in CABANA, said Dr. Packer, professor and a cardiac electrophysiologist at the Mayo Clinic in Rochester, Minn.
Notably however, the results Dr. Packer reported on the heart failure subgroup did not include any information on how many of these were patients who had HFrEF or heart failure with preserved ejection fraction and how the apparent benefit from AF ablation affected each of these two heart failure types. In addition, the reported CABANA results did not have an endpoint result that completely matched the mortality and heart failure hospitalization composite endpoint used in CASTLE-AF. The closest endpoint that Dr. Packer reported from CABANA was a composite of mortality and cardiovascular hospitalization that showed, for the entire CABANA cohort, a statistically significant 17% relative reduction with ablation in the intention-to-treat analysis. Dr. Packer gave no data on how this outcome shook out in the subgroup of heart failure patients.
Despite these limitations, in trying to synthesize the CABANA and CASTLE-AF results, several electrophysiologists who heard the results agreed with Dr. Packer that the CABANA results confirmed the CASTLE-AF findings and helped strengthen the case for strongly considering AF ablation as first-line treatment in patients with heart failure.
“It’s clear that sinus rhythm is important in patients with heart failure. CASTLE-AF and now these results; that’s very strong to me,” said Eric N. Prystowsky, MD, a cardiac electrophysiologist with the St. Vincent Medical Group in Indianapolis and designated discussant for CABANA at the meeting.
“It’s confirmatory,” said Nassir F. Marrouche, MD, lead investigator for CASTLE-AF, and professor and director of the electrophysiology laboratory at the University of Utah in Salt Lake City.
The “signal” of benefit from AF ablation in heart failure patients in CABANA “replicates what was seen in CASTLE-AF. The results are highly consistent and very important regarding how to treat patients with AF and heart failure,” said Jeremy N. Ruskin, MD, professor of medicine at Harvard Medical School and director of the cardiac arrhythmia service at Massachusetts General Hospital, both in Boston. “The data strongly suggest that catheter ablation is helpful for restoring and preserving [heart] muscle function,” Dr. Ruskin said in a video interview. He noted that AF occurs in at least about a quarter of heart failure patients.
Other cardiologists at the meeting noted that, on the basis of the CASTLE-AF results alone, they have already become more aggressive about treating AF with ablation in patients with heart failure in routine practice.
“It adds to the armamentarium for treatment of patients with heart failure,” said Johannes Brachmann, MD, professor and chief of cardiology at the Coburg (Germany) Clinic and a senior coinvestigator for CASTLE-AF.
William T. Abraham, MD, a heart failure specialist at The Ohio State University in Columbus, offered a broader perspective on where AF diagnosis, treatment, and ablation currently stand in U.S. heart failure practice.
“There is a very tight link between AF burden and worse outcomes in heart failure, so there is something intuitively appealing about restoring sinus rhythm in heart failure patients. I think most heart failure clinicians believe, like me, that heart failure patients with AF benefit from restoration of normal sinus rhythm. But I don’t believe that the CASTLE-AF results have so far had much impact on practice, in part because it was a relatively small study. The heart failure community is looking for some confirmation,” said Dr. Abraham, professor and director of cardiovascular medicine at Ohio State.
“I think the CABANA results are encouraging, but they came from only 15% of the enrolled patients who also had heart failure. CABANA adds to our knowledge, but I’m not sure it’s definitive for the heart failure population. I’m not sure it tells us if you treat patients with heart failure with anti-arrhythmia drugs and successfully maintain sinus rhythm do those patients do just as well as those who get ablated,” he said in an interview. “I’d love to see a study of heart failure patients maintained in sinus rhythm with drugs compared with those treated with ablation.”
For most patients with heart failure, the coexistence of AF is identified because of AF symptoms, or when asymptomatic AF is found in recordings made by an implanted cardiac device. “I’m more aggressive about addressing asymptomatic AF in my heart failure patients, and I believe the heart failure community is moving rapidly in that direction because of the association between higher AF burden and worse heart failure outcomes,” Dr. Abraham said.
A more cautious view came from another heart failure specialist, Clyde Yancy, MD, professor and chief of cardiology at Northwestern University in Chicago. “It’s pretty evident that in certain patients with heart failure AF ablation might be the right treatment, but is it every HFrEF patient with AF?” he wondered. “It’s nice to have more evidence so we can be more comfortable sending heart failure patients for ablation, but I want to see more information about the risk” from ablation in heart failure patients, “the sustainability of the effect, and the consequences of ablation.”
But the reservations expressed by cardiologists like Dr. Yancy contrasted with the views of colleagues who consider the current evidence much more convincing.
“It seems logical to look harder for AF” in heart failure patients, based on the accumulated evidence from CASTLE-AF and CABANA, said Dr. Ruskin. “I don’t think we can offer advice to heart failure physicians to screen their heart failure patients for AF, but if it’s seen I think we have some useful information on how to address it.”
CASTLE-AF was funded by Biotronik. CABANA received partial funding from Biosense Webster, Boston Scientific, Medtronic, and St. Jude. Dr. Packer has been a consultant to and has received research funding from Biosense Webster, Boston Scientific, Medtronic, and St. Jude, and also from several other companies. Dr. Prystowsky as been a consultant to CardioNet and Medtronic, he has an equity interest in Stereotaxis, and he receives fellowship support from Medtronic and St. Jude. Dr. Marrouche has been a consultant to Biosense Webster, Biotronik, Boston Scientific, and St. Jude. He has received research support from Medtronic, and he has had financial relationships with several other companies. Dr. Ruskin has been a consultant to Biosense Webster and Medtronic and several other companies, has an ownership interest in Amgen, Cameron Health, InfoBionic, Newpace, Portola, and Regeneron, and has a fiduciary role in Pharmaco-Kinesis. Dr. Russo and Dr. Yancy had no disclosures. Dr. Brachmann has been a consultant to and has received research funding from Biotronik, Boston Scientific, St. Jude, and several other companies. Dr. Abraham has been a consultant to Abbott Vascular, Medtronic, Novartis, and St. Jude.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
BOSTON – Results from two recent trials suggest that cardiologists may have a new way to improve outcomes in patients with heart failure with reduced ejection fraction if they also have atrial fibrillation: Cut the patient’s atrial fibrillation burden with catheter ablation.
This seemingly off-target approach to improving survival, avoiding heart failure hospitalizations, and possibly reducing other adverse events first gained attention with results from the CASTLE-AF (Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF) randomized trial, first reported in 2017. The study showed in 363 patients that atrial fibrillation (AF) ablation in patients with heart failure with reduced ejection fraction (HFrEF) led to a statistically significant 38% relative reduction in the primary endpoint of mortality or heart failure hospitalization during a median 38 months of follow-up (N Engl J Med. 2018 Feb 1;378[5]:417-27).
This groundbreaking finding then received some degree of confirmation when Douglas L. Packer, MD, reported primary results from CABANA (Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial) at the annual scientific sessions of the Heart Rhythm Society. CABANA compared upfront ablation against first-line medical management of AF in 2,203 patients. While the primary endpoint of the cumulative rate of all-cause death, disabling stroke, serious bleeding, or cardiac arrest over a median follow-up of just over 4 years was neutral, with no statistically significant difference between the two treatment arms, a subgroup analysis showed a tantalizing suggestion of benefit in the 337 enrolled patients with a history of congestive heart failure (15% of the total study group).
In this subgroup, treatment with ablation cut the primary endpoint by 39% relative to those treated upfront with medical management, an effect that came close to statistical significance. In addition, Dr. Packer took special note of the per-protocol analysis, which censored out the crossover patients who constituted roughly a fifth of all enrolled patients. In the subgroup analysis using the per-protocol data, ablation was linked with a statistically significant 49% relative reduction in the primary endpoint among patients with a history of heart failure.
The patients for whom there may be the quickest shift to upfront ablation to treat AF based on the CABANA results will be those with heart failure and others with high underlying risk, Dr. Packer predicted at the meeting.
“The CASTLE-AF results were interesting, but in fewer than 400 patients. Now we’ve basically seen the same thing” in CABANA, said Dr. Packer, professor and a cardiac electrophysiologist at the Mayo Clinic in Rochester, Minn.
Notably however, the results Dr. Packer reported on the heart failure subgroup did not include any information on how many of these were patients who had HFrEF or heart failure with preserved ejection fraction and how the apparent benefit from AF ablation affected each of these two heart failure types. In addition, the reported CABANA results did not have an endpoint result that completely matched the mortality and heart failure hospitalization composite endpoint used in CASTLE-AF. The closest endpoint that Dr. Packer reported from CABANA was a composite of mortality and cardiovascular hospitalization that showed, for the entire CABANA cohort, a statistically significant 17% relative reduction with ablation in the intention-to-treat analysis. Dr. Packer gave no data on how this outcome shook out in the subgroup of heart failure patients.
Despite these limitations, in trying to synthesize the CABANA and CASTLE-AF results, several electrophysiologists who heard the results agreed with Dr. Packer that the CABANA results confirmed the CASTLE-AF findings and helped strengthen the case for strongly considering AF ablation as first-line treatment in patients with heart failure.
“It’s clear that sinus rhythm is important in patients with heart failure. CASTLE-AF and now these results; that’s very strong to me,” said Eric N. Prystowsky, MD, a cardiac electrophysiologist with the St. Vincent Medical Group in Indianapolis and designated discussant for CABANA at the meeting.
“It’s confirmatory,” said Nassir F. Marrouche, MD, lead investigator for CASTLE-AF, and professor and director of the electrophysiology laboratory at the University of Utah in Salt Lake City.
The “signal” of benefit from AF ablation in heart failure patients in CABANA “replicates what was seen in CASTLE-AF. The results are highly consistent and very important regarding how to treat patients with AF and heart failure,” said Jeremy N. Ruskin, MD, professor of medicine at Harvard Medical School and director of the cardiac arrhythmia service at Massachusetts General Hospital, both in Boston. “The data strongly suggest that catheter ablation is helpful for restoring and preserving [heart] muscle function,” Dr. Ruskin said in a video interview. He noted that AF occurs in at least about a quarter of heart failure patients.
Other cardiologists at the meeting noted that, on the basis of the CASTLE-AF results alone, they have already become more aggressive about treating AF with ablation in patients with heart failure in routine practice.
“It adds to the armamentarium for treatment of patients with heart failure,” said Johannes Brachmann, MD, professor and chief of cardiology at the Coburg (Germany) Clinic and a senior coinvestigator for CASTLE-AF.
William T. Abraham, MD, a heart failure specialist at The Ohio State University in Columbus, offered a broader perspective on where AF diagnosis, treatment, and ablation currently stand in U.S. heart failure practice.
“There is a very tight link between AF burden and worse outcomes in heart failure, so there is something intuitively appealing about restoring sinus rhythm in heart failure patients. I think most heart failure clinicians believe, like me, that heart failure patients with AF benefit from restoration of normal sinus rhythm. But I don’t believe that the CASTLE-AF results have so far had much impact on practice, in part because it was a relatively small study. The heart failure community is looking for some confirmation,” said Dr. Abraham, professor and director of cardiovascular medicine at Ohio State.
“I think the CABANA results are encouraging, but they came from only 15% of the enrolled patients who also had heart failure. CABANA adds to our knowledge, but I’m not sure it’s definitive for the heart failure population. I’m not sure it tells us if you treat patients with heart failure with anti-arrhythmia drugs and successfully maintain sinus rhythm do those patients do just as well as those who get ablated,” he said in an interview. “I’d love to see a study of heart failure patients maintained in sinus rhythm with drugs compared with those treated with ablation.”
For most patients with heart failure, the coexistence of AF is identified because of AF symptoms, or when asymptomatic AF is found in recordings made by an implanted cardiac device. “I’m more aggressive about addressing asymptomatic AF in my heart failure patients, and I believe the heart failure community is moving rapidly in that direction because of the association between higher AF burden and worse heart failure outcomes,” Dr. Abraham said.
A more cautious view came from another heart failure specialist, Clyde Yancy, MD, professor and chief of cardiology at Northwestern University in Chicago. “It’s pretty evident that in certain patients with heart failure AF ablation might be the right treatment, but is it every HFrEF patient with AF?” he wondered. “It’s nice to have more evidence so we can be more comfortable sending heart failure patients for ablation, but I want to see more information about the risk” from ablation in heart failure patients, “the sustainability of the effect, and the consequences of ablation.”
But the reservations expressed by cardiologists like Dr. Yancy contrasted with the views of colleagues who consider the current evidence much more convincing.
“It seems logical to look harder for AF” in heart failure patients, based on the accumulated evidence from CASTLE-AF and CABANA, said Dr. Ruskin. “I don’t think we can offer advice to heart failure physicians to screen their heart failure patients for AF, but if it’s seen I think we have some useful information on how to address it.”
CASTLE-AF was funded by Biotronik. CABANA received partial funding from Biosense Webster, Boston Scientific, Medtronic, and St. Jude. Dr. Packer has been a consultant to and has received research funding from Biosense Webster, Boston Scientific, Medtronic, and St. Jude, and also from several other companies. Dr. Prystowsky as been a consultant to CardioNet and Medtronic, he has an equity interest in Stereotaxis, and he receives fellowship support from Medtronic and St. Jude. Dr. Marrouche has been a consultant to Biosense Webster, Biotronik, Boston Scientific, and St. Jude. He has received research support from Medtronic, and he has had financial relationships with several other companies. Dr. Ruskin has been a consultant to Biosense Webster and Medtronic and several other companies, has an ownership interest in Amgen, Cameron Health, InfoBionic, Newpace, Portola, and Regeneron, and has a fiduciary role in Pharmaco-Kinesis. Dr. Russo and Dr. Yancy had no disclosures. Dr. Brachmann has been a consultant to and has received research funding from Biotronik, Boston Scientific, St. Jude, and several other companies. Dr. Abraham has been a consultant to Abbott Vascular, Medtronic, Novartis, and St. Jude.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
BOSTON – Results from two recent trials suggest that cardiologists may have a new way to improve outcomes in patients with heart failure with reduced ejection fraction if they also have atrial fibrillation: Cut the patient’s atrial fibrillation burden with catheter ablation.
This seemingly off-target approach to improving survival, avoiding heart failure hospitalizations, and possibly reducing other adverse events first gained attention with results from the CASTLE-AF (Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF) randomized trial, first reported in 2017. The study showed in 363 patients that atrial fibrillation (AF) ablation in patients with heart failure with reduced ejection fraction (HFrEF) led to a statistically significant 38% relative reduction in the primary endpoint of mortality or heart failure hospitalization during a median 38 months of follow-up (N Engl J Med. 2018 Feb 1;378[5]:417-27).
This groundbreaking finding then received some degree of confirmation when Douglas L. Packer, MD, reported primary results from CABANA (Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial) at the annual scientific sessions of the Heart Rhythm Society. CABANA compared upfront ablation against first-line medical management of AF in 2,203 patients. While the primary endpoint of the cumulative rate of all-cause death, disabling stroke, serious bleeding, or cardiac arrest over a median follow-up of just over 4 years was neutral, with no statistically significant difference between the two treatment arms, a subgroup analysis showed a tantalizing suggestion of benefit in the 337 enrolled patients with a history of congestive heart failure (15% of the total study group).
In this subgroup, treatment with ablation cut the primary endpoint by 39% relative to those treated upfront with medical management, an effect that came close to statistical significance. In addition, Dr. Packer took special note of the per-protocol analysis, which censored out the crossover patients who constituted roughly a fifth of all enrolled patients. In the subgroup analysis using the per-protocol data, ablation was linked with a statistically significant 49% relative reduction in the primary endpoint among patients with a history of heart failure.
The patients for whom there may be the quickest shift to upfront ablation to treat AF based on the CABANA results will be those with heart failure and others with high underlying risk, Dr. Packer predicted at the meeting.
“The CASTLE-AF results were interesting, but in fewer than 400 patients. Now we’ve basically seen the same thing” in CABANA, said Dr. Packer, professor and a cardiac electrophysiologist at the Mayo Clinic in Rochester, Minn.
Notably however, the results Dr. Packer reported on the heart failure subgroup did not include any information on how many of these were patients who had HFrEF or heart failure with preserved ejection fraction and how the apparent benefit from AF ablation affected each of these two heart failure types. In addition, the reported CABANA results did not have an endpoint result that completely matched the mortality and heart failure hospitalization composite endpoint used in CASTLE-AF. The closest endpoint that Dr. Packer reported from CABANA was a composite of mortality and cardiovascular hospitalization that showed, for the entire CABANA cohort, a statistically significant 17% relative reduction with ablation in the intention-to-treat analysis. Dr. Packer gave no data on how this outcome shook out in the subgroup of heart failure patients.
Despite these limitations, in trying to synthesize the CABANA and CASTLE-AF results, several electrophysiologists who heard the results agreed with Dr. Packer that the CABANA results confirmed the CASTLE-AF findings and helped strengthen the case for strongly considering AF ablation as first-line treatment in patients with heart failure.
“It’s clear that sinus rhythm is important in patients with heart failure. CASTLE-AF and now these results; that’s very strong to me,” said Eric N. Prystowsky, MD, a cardiac electrophysiologist with the St. Vincent Medical Group in Indianapolis and designated discussant for CABANA at the meeting.
“It’s confirmatory,” said Nassir F. Marrouche, MD, lead investigator for CASTLE-AF, and professor and director of the electrophysiology laboratory at the University of Utah in Salt Lake City.
The “signal” of benefit from AF ablation in heart failure patients in CABANA “replicates what was seen in CASTLE-AF. The results are highly consistent and very important regarding how to treat patients with AF and heart failure,” said Jeremy N. Ruskin, MD, professor of medicine at Harvard Medical School and director of the cardiac arrhythmia service at Massachusetts General Hospital, both in Boston. “The data strongly suggest that catheter ablation is helpful for restoring and preserving [heart] muscle function,” Dr. Ruskin said in a video interview. He noted that AF occurs in at least about a quarter of heart failure patients.
Other cardiologists at the meeting noted that, on the basis of the CASTLE-AF results alone, they have already become more aggressive about treating AF with ablation in patients with heart failure in routine practice.
“It adds to the armamentarium for treatment of patients with heart failure,” said Johannes Brachmann, MD, professor and chief of cardiology at the Coburg (Germany) Clinic and a senior coinvestigator for CASTLE-AF.
William T. Abraham, MD, a heart failure specialist at The Ohio State University in Columbus, offered a broader perspective on where AF diagnosis, treatment, and ablation currently stand in U.S. heart failure practice.
“There is a very tight link between AF burden and worse outcomes in heart failure, so there is something intuitively appealing about restoring sinus rhythm in heart failure patients. I think most heart failure clinicians believe, like me, that heart failure patients with AF benefit from restoration of normal sinus rhythm. But I don’t believe that the CASTLE-AF results have so far had much impact on practice, in part because it was a relatively small study. The heart failure community is looking for some confirmation,” said Dr. Abraham, professor and director of cardiovascular medicine at Ohio State.
“I think the CABANA results are encouraging, but they came from only 15% of the enrolled patients who also had heart failure. CABANA adds to our knowledge, but I’m not sure it’s definitive for the heart failure population. I’m not sure it tells us if you treat patients with heart failure with anti-arrhythmia drugs and successfully maintain sinus rhythm do those patients do just as well as those who get ablated,” he said in an interview. “I’d love to see a study of heart failure patients maintained in sinus rhythm with drugs compared with those treated with ablation.”
For most patients with heart failure, the coexistence of AF is identified because of AF symptoms, or when asymptomatic AF is found in recordings made by an implanted cardiac device. “I’m more aggressive about addressing asymptomatic AF in my heart failure patients, and I believe the heart failure community is moving rapidly in that direction because of the association between higher AF burden and worse heart failure outcomes,” Dr. Abraham said.
A more cautious view came from another heart failure specialist, Clyde Yancy, MD, professor and chief of cardiology at Northwestern University in Chicago. “It’s pretty evident that in certain patients with heart failure AF ablation might be the right treatment, but is it every HFrEF patient with AF?” he wondered. “It’s nice to have more evidence so we can be more comfortable sending heart failure patients for ablation, but I want to see more information about the risk” from ablation in heart failure patients, “the sustainability of the effect, and the consequences of ablation.”
But the reservations expressed by cardiologists like Dr. Yancy contrasted with the views of colleagues who consider the current evidence much more convincing.
“It seems logical to look harder for AF” in heart failure patients, based on the accumulated evidence from CASTLE-AF and CABANA, said Dr. Ruskin. “I don’t think we can offer advice to heart failure physicians to screen their heart failure patients for AF, but if it’s seen I think we have some useful information on how to address it.”
CASTLE-AF was funded by Biotronik. CABANA received partial funding from Biosense Webster, Boston Scientific, Medtronic, and St. Jude. Dr. Packer has been a consultant to and has received research funding from Biosense Webster, Boston Scientific, Medtronic, and St. Jude, and also from several other companies. Dr. Prystowsky as been a consultant to CardioNet and Medtronic, he has an equity interest in Stereotaxis, and he receives fellowship support from Medtronic and St. Jude. Dr. Marrouche has been a consultant to Biosense Webster, Biotronik, Boston Scientific, and St. Jude. He has received research support from Medtronic, and he has had financial relationships with several other companies. Dr. Ruskin has been a consultant to Biosense Webster and Medtronic and several other companies, has an ownership interest in Amgen, Cameron Health, InfoBionic, Newpace, Portola, and Regeneron, and has a fiduciary role in Pharmaco-Kinesis. Dr. Russo and Dr. Yancy had no disclosures. Dr. Brachmann has been a consultant to and has received research funding from Biotronik, Boston Scientific, St. Jude, and several other companies. Dr. Abraham has been a consultant to Abbott Vascular, Medtronic, Novartis, and St. Jude.
EXPERT ANALYSIS FROM HEART RHYTHM 2018
FDA recalls HeartMate 3 LV assist device
The HeartMate 3 left ventricular assist device received a class 1 recall from the Food and Drug Administration on May 17, an action the agency publicly announced on May 22.
The FDA’s step formalized a “corrective action” that the HeartMate 3’s manufacturer, Abbott, first issued in early April and then announced in early May, which said the device used to treat patients with severe advanced heart failure was subject to “outflow graft twist occlusions” that trigger a persistent low-flow alarm and “can result in serious adverse events such as hemodynamic compromise, thrombus, and death,” according to the FDA’s May 17 statement.
The class 1 recall category the FDA applied means the agency rates the danger posed as a “situation where there is a reasonable chance that a product will cause serious health problems or death.” However, in its statements, the agency has not suggested removing a well-functioning device from patients, nor has the agency called for discontinuing new placements of the HeartMate 3. The FDA gave a full endorsement to the approach Abbott suggested in its April 5 “Dear Physician” letter and then followed with a second letter on May 21.
The first letter attributed development of these twists in the tube that directs blood out from the device to accumulated mechanical forces from heartbeats, respiration, and activity, and also provided some management guidance that Abbott then expanded in its second letter.
The FDA cited some of the key steps Abbott recommended clinicians take with patients who receive a HeartMate 3. This included regular surveillance with transthoracic echocardiography, although echo is not considered definitive for identifying a graft twist obstruction and hence other investigations may also be needed. If the low-flow alarm sounds, a CT scan is “urgently” needed – as long as it’s not contraindicated – to identify a possible outflow twist. Abbott noted that surgical intervention may be needed to correct a twist.
Researchers recently reported 2-year follow-up data from 257 patients in MOMENTUM 3, the randomized pivotal trial for the HeartMate 3 that compared this fully magnetically levitated centrifugal-flow pump to the prior-generation, axial-flow pump. The composite endpoint of freedom from death, stroke, or need for repeat surgery after 2 years was 80% in the HeartMate 3 recipients and 60% among patients in the control arm who received the older-model device (N Engl J Med. 2018 April 12; 378[15]:1386-95).
The HeartMate 3 left ventricular assist device received a class 1 recall from the Food and Drug Administration on May 17, an action the agency publicly announced on May 22.
The FDA’s step formalized a “corrective action” that the HeartMate 3’s manufacturer, Abbott, first issued in early April and then announced in early May, which said the device used to treat patients with severe advanced heart failure was subject to “outflow graft twist occlusions” that trigger a persistent low-flow alarm and “can result in serious adverse events such as hemodynamic compromise, thrombus, and death,” according to the FDA’s May 17 statement.
The class 1 recall category the FDA applied means the agency rates the danger posed as a “situation where there is a reasonable chance that a product will cause serious health problems or death.” However, in its statements, the agency has not suggested removing a well-functioning device from patients, nor has the agency called for discontinuing new placements of the HeartMate 3. The FDA gave a full endorsement to the approach Abbott suggested in its April 5 “Dear Physician” letter and then followed with a second letter on May 21.
The first letter attributed development of these twists in the tube that directs blood out from the device to accumulated mechanical forces from heartbeats, respiration, and activity, and also provided some management guidance that Abbott then expanded in its second letter.
The FDA cited some of the key steps Abbott recommended clinicians take with patients who receive a HeartMate 3. This included regular surveillance with transthoracic echocardiography, although echo is not considered definitive for identifying a graft twist obstruction and hence other investigations may also be needed. If the low-flow alarm sounds, a CT scan is “urgently” needed – as long as it’s not contraindicated – to identify a possible outflow twist. Abbott noted that surgical intervention may be needed to correct a twist.
Researchers recently reported 2-year follow-up data from 257 patients in MOMENTUM 3, the randomized pivotal trial for the HeartMate 3 that compared this fully magnetically levitated centrifugal-flow pump to the prior-generation, axial-flow pump. The composite endpoint of freedom from death, stroke, or need for repeat surgery after 2 years was 80% in the HeartMate 3 recipients and 60% among patients in the control arm who received the older-model device (N Engl J Med. 2018 April 12; 378[15]:1386-95).
The HeartMate 3 left ventricular assist device received a class 1 recall from the Food and Drug Administration on May 17, an action the agency publicly announced on May 22.
The FDA’s step formalized a “corrective action” that the HeartMate 3’s manufacturer, Abbott, first issued in early April and then announced in early May, which said the device used to treat patients with severe advanced heart failure was subject to “outflow graft twist occlusions” that trigger a persistent low-flow alarm and “can result in serious adverse events such as hemodynamic compromise, thrombus, and death,” according to the FDA’s May 17 statement.
The class 1 recall category the FDA applied means the agency rates the danger posed as a “situation where there is a reasonable chance that a product will cause serious health problems or death.” However, in its statements, the agency has not suggested removing a well-functioning device from patients, nor has the agency called for discontinuing new placements of the HeartMate 3. The FDA gave a full endorsement to the approach Abbott suggested in its April 5 “Dear Physician” letter and then followed with a second letter on May 21.
The first letter attributed development of these twists in the tube that directs blood out from the device to accumulated mechanical forces from heartbeats, respiration, and activity, and also provided some management guidance that Abbott then expanded in its second letter.
The FDA cited some of the key steps Abbott recommended clinicians take with patients who receive a HeartMate 3. This included regular surveillance with transthoracic echocardiography, although echo is not considered definitive for identifying a graft twist obstruction and hence other investigations may also be needed. If the low-flow alarm sounds, a CT scan is “urgently” needed – as long as it’s not contraindicated – to identify a possible outflow twist. Abbott noted that surgical intervention may be needed to correct a twist.
Researchers recently reported 2-year follow-up data from 257 patients in MOMENTUM 3, the randomized pivotal trial for the HeartMate 3 that compared this fully magnetically levitated centrifugal-flow pump to the prior-generation, axial-flow pump. The composite endpoint of freedom from death, stroke, or need for repeat surgery after 2 years was 80% in the HeartMate 3 recipients and 60% among patients in the control arm who received the older-model device (N Engl J Med. 2018 April 12; 378[15]:1386-95).
FDA approval expected for CCM in heart failure patients
BOSTON – Positive results from a confirmatory trial appear to put the Optimizer by Impulse Dynamics, a cardiac contractility modulation (CCM) device for patients with function-limiting heart failure, on track for imminent U.S. marketing approval by the Food and Drug Administration. If that happens, several hundreds of thousands of U.S. heart failure patients would immediately become candidates for this treatment based on the enrolled study populations, the benefits shown, and current treatment options for advanced heart failure, experts predicted.
CCM “promises to meet a very large unmet need in heart failure,” William T. Abraham, MD, said as he presented the confirmatory study’s results at the annual scientific sessions of the Heart Rhythm Society. ”These patients aren’t doing well, but don’t qualify” for a heart transplant, left ventricular assist device, implantable cardioverter defibrillator, or cardiac resynchronization therapy (CRT), noted Dr. Abraham, professor and director of cardiovascular medicine at the Ohio State University in Columbus. In the months following the anticipated FDA approval, Dr. Abraham said he expects the device will be implanted in tens of thousands of U.S. heart failure patients who match the criteria of those who got the biggest benefit from CCM.
“There are few if any evidence-based treatments for patients with an ejection fraction of 35%-45%. This is an underserved population, so the potential of CCM is appropriately high,” Dr. Abraham said.
Researchers designed the study in consultation with the FDA to resolve lingering regulatory concerns following completion of three prior randomized trials with a total of nearly 650 patients. Dr. Abraham simultaneously reported the results at the meeting and published them in a report (JACC Heart Failure. 2018 May 10. doi: 10.1016/j.jchf.2018.04.010); these results from 160 patients – 74 of whom received the device and 86 of whom continued medical therapy – showed the superiority of the device for the primary endpoint of change in exercise capacity (as measured by peak oxygen uptake) and for the secondary endpoints of quality of life (as measured with the Minnesota Living With Heart Failure Questionnaire) and functional status (as measured by New York Heart Association class). The boost in exercise capacity, an average increase of 0.84 ml/kg per min in peak oxygen uptake after 24 weeks, “was similar to the improvement seen with CRT in patients with a wide QRS interval” who thereby qualified for CRT placement, Dr. Abraham said.
The CCM device also met the study’s prespecified safety endpoint of a complication rate of less than 30% – with an actual rate of 10%. “The complications were those we expect from implanted leads and pulse generators and were comparable to what happens with other implanted rhythm devices. In the context of the benefits patients received and their having no other treatment options, I see the complication rate as acceptable,” Dr. Abraham said during his report.
In summing up the trial’s results, Dr. Stevenson noted that “the safety endpoint was met, the primary endpoint and other functional endpoints were met, and functional endpoints are of vital importance to patients. The CCM story is not yet the CRT story,” with CRT having produced even larger effects in its pivotal trial, also led by Dr. Abraham (New Engl J Med. 2002 June 13;346[24]:1845-53), cautioned Dr. Stevenson. But in general she put a positive spin on the CCM device, saying that it “has ingenuity and innovation, and we look forward to a better understanding of which patients benefit from CCM and what we can tell them about the magnitude and duration of the benefit.”
The FIX-HF-5C trial was sponsored by Impulse Dynamics, the company developing the CCM Optimizer device. Dr. Abraham has been a consultant to Impulse Dynamics, as well as to Abbott Vascular, Medtronic, Novartis, and St. Jude Medical. Dr. Singh has been a consultant to Biotronik, Boston Scientific, Liva Nova, Medtronic, and St. Jude. Dr. Stevenson has received research funding from Abbott and Novartis. Dr. Yancy had no disclosures.
SOURCE: Abraham W et al. Heart Rhythm 2018, Abstract B-LBCT01-02.
BOSTON – Positive results from a confirmatory trial appear to put the Optimizer by Impulse Dynamics, a cardiac contractility modulation (CCM) device for patients with function-limiting heart failure, on track for imminent U.S. marketing approval by the Food and Drug Administration. If that happens, several hundreds of thousands of U.S. heart failure patients would immediately become candidates for this treatment based on the enrolled study populations, the benefits shown, and current treatment options for advanced heart failure, experts predicted.
CCM “promises to meet a very large unmet need in heart failure,” William T. Abraham, MD, said as he presented the confirmatory study’s results at the annual scientific sessions of the Heart Rhythm Society. ”These patients aren’t doing well, but don’t qualify” for a heart transplant, left ventricular assist device, implantable cardioverter defibrillator, or cardiac resynchronization therapy (CRT), noted Dr. Abraham, professor and director of cardiovascular medicine at the Ohio State University in Columbus. In the months following the anticipated FDA approval, Dr. Abraham said he expects the device will be implanted in tens of thousands of U.S. heart failure patients who match the criteria of those who got the biggest benefit from CCM.
“There are few if any evidence-based treatments for patients with an ejection fraction of 35%-45%. This is an underserved population, so the potential of CCM is appropriately high,” Dr. Abraham said.
Researchers designed the study in consultation with the FDA to resolve lingering regulatory concerns following completion of three prior randomized trials with a total of nearly 650 patients. Dr. Abraham simultaneously reported the results at the meeting and published them in a report (JACC Heart Failure. 2018 May 10. doi: 10.1016/j.jchf.2018.04.010); these results from 160 patients – 74 of whom received the device and 86 of whom continued medical therapy – showed the superiority of the device for the primary endpoint of change in exercise capacity (as measured by peak oxygen uptake) and for the secondary endpoints of quality of life (as measured with the Minnesota Living With Heart Failure Questionnaire) and functional status (as measured by New York Heart Association class). The boost in exercise capacity, an average increase of 0.84 ml/kg per min in peak oxygen uptake after 24 weeks, “was similar to the improvement seen with CRT in patients with a wide QRS interval” who thereby qualified for CRT placement, Dr. Abraham said.
The CCM device also met the study’s prespecified safety endpoint of a complication rate of less than 30% – with an actual rate of 10%. “The complications were those we expect from implanted leads and pulse generators and were comparable to what happens with other implanted rhythm devices. In the context of the benefits patients received and their having no other treatment options, I see the complication rate as acceptable,” Dr. Abraham said during his report.
In summing up the trial’s results, Dr. Stevenson noted that “the safety endpoint was met, the primary endpoint and other functional endpoints were met, and functional endpoints are of vital importance to patients. The CCM story is not yet the CRT story,” with CRT having produced even larger effects in its pivotal trial, also led by Dr. Abraham (New Engl J Med. 2002 June 13;346[24]:1845-53), cautioned Dr. Stevenson. But in general she put a positive spin on the CCM device, saying that it “has ingenuity and innovation, and we look forward to a better understanding of which patients benefit from CCM and what we can tell them about the magnitude and duration of the benefit.”
The FIX-HF-5C trial was sponsored by Impulse Dynamics, the company developing the CCM Optimizer device. Dr. Abraham has been a consultant to Impulse Dynamics, as well as to Abbott Vascular, Medtronic, Novartis, and St. Jude Medical. Dr. Singh has been a consultant to Biotronik, Boston Scientific, Liva Nova, Medtronic, and St. Jude. Dr. Stevenson has received research funding from Abbott and Novartis. Dr. Yancy had no disclosures.
SOURCE: Abraham W et al. Heart Rhythm 2018, Abstract B-LBCT01-02.
BOSTON – Positive results from a confirmatory trial appear to put the Optimizer by Impulse Dynamics, a cardiac contractility modulation (CCM) device for patients with function-limiting heart failure, on track for imminent U.S. marketing approval by the Food and Drug Administration. If that happens, several hundreds of thousands of U.S. heart failure patients would immediately become candidates for this treatment based on the enrolled study populations, the benefits shown, and current treatment options for advanced heart failure, experts predicted.
CCM “promises to meet a very large unmet need in heart failure,” William T. Abraham, MD, said as he presented the confirmatory study’s results at the annual scientific sessions of the Heart Rhythm Society. ”These patients aren’t doing well, but don’t qualify” for a heart transplant, left ventricular assist device, implantable cardioverter defibrillator, or cardiac resynchronization therapy (CRT), noted Dr. Abraham, professor and director of cardiovascular medicine at the Ohio State University in Columbus. In the months following the anticipated FDA approval, Dr. Abraham said he expects the device will be implanted in tens of thousands of U.S. heart failure patients who match the criteria of those who got the biggest benefit from CCM.
“There are few if any evidence-based treatments for patients with an ejection fraction of 35%-45%. This is an underserved population, so the potential of CCM is appropriately high,” Dr. Abraham said.
Researchers designed the study in consultation with the FDA to resolve lingering regulatory concerns following completion of three prior randomized trials with a total of nearly 650 patients. Dr. Abraham simultaneously reported the results at the meeting and published them in a report (JACC Heart Failure. 2018 May 10. doi: 10.1016/j.jchf.2018.04.010); these results from 160 patients – 74 of whom received the device and 86 of whom continued medical therapy – showed the superiority of the device for the primary endpoint of change in exercise capacity (as measured by peak oxygen uptake) and for the secondary endpoints of quality of life (as measured with the Minnesota Living With Heart Failure Questionnaire) and functional status (as measured by New York Heart Association class). The boost in exercise capacity, an average increase of 0.84 ml/kg per min in peak oxygen uptake after 24 weeks, “was similar to the improvement seen with CRT in patients with a wide QRS interval” who thereby qualified for CRT placement, Dr. Abraham said.
The CCM device also met the study’s prespecified safety endpoint of a complication rate of less than 30% – with an actual rate of 10%. “The complications were those we expect from implanted leads and pulse generators and were comparable to what happens with other implanted rhythm devices. In the context of the benefits patients received and their having no other treatment options, I see the complication rate as acceptable,” Dr. Abraham said during his report.
In summing up the trial’s results, Dr. Stevenson noted that “the safety endpoint was met, the primary endpoint and other functional endpoints were met, and functional endpoints are of vital importance to patients. The CCM story is not yet the CRT story,” with CRT having produced even larger effects in its pivotal trial, also led by Dr. Abraham (New Engl J Med. 2002 June 13;346[24]:1845-53), cautioned Dr. Stevenson. But in general she put a positive spin on the CCM device, saying that it “has ingenuity and innovation, and we look forward to a better understanding of which patients benefit from CCM and what we can tell them about the magnitude and duration of the benefit.”
The FIX-HF-5C trial was sponsored by Impulse Dynamics, the company developing the CCM Optimizer device. Dr. Abraham has been a consultant to Impulse Dynamics, as well as to Abbott Vascular, Medtronic, Novartis, and St. Jude Medical. Dr. Singh has been a consultant to Biotronik, Boston Scientific, Liva Nova, Medtronic, and St. Jude. Dr. Stevenson has received research funding from Abbott and Novartis. Dr. Yancy had no disclosures.
SOURCE: Abraham W et al. Heart Rhythm 2018, Abstract B-LBCT01-02.
REPORTING FROM HEART RHYTHM 2018
VIDEO: CASTLE-AF suggests atrial fibrillation burden better predicts outcomes
BOSTON – From the earliest days of using catheter ablation to treat atrial fibrillation (AF), in the 1990s, clinicians have defined ablation success based on whether patients had recurrence of their arrhythmia following treatment. New findings suggest that this standard was off, and that
The new study used data collected in the CASTLE-AF (Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF) multicenter trial, which compared the efficacy of AF ablation with antiarrhythmic drug treatment in patients with heart failure for improving survival and freedom from hospitalization for heart failure. The trial’s primary finding showed that, in 363 randomized patients, AF ablation cut the primary adverse event rate by 38% relative to antiarrhythmic drug therapy (New Engl J Med. 2018 Feb 1;378[5]:417-27)
“There have been concerns about the high recurrence rate of AF following ablation,” with reported cumulative recurrence rates running as high as 80% by 5 years after ablation, noted Dr. Brachmann. “The news now is that recurrence alone doesn’t make a difference; we can still help patients” by reducing their AF burden, although he cautioned that this relationship has so far only been seen in patients with heart failure with reduced ejection fraction, the type of patients enrolled in CASTLE-AF.
“This information is very informative for clinicians counseling patients who undergo ablation. Ablation may not eliminate all of a patient’s AF, but it will substantially reduce it, and that’s associated with better outcomes,” commented Andrew D. Krahn, MD, professor and chief of cardiology at the University of British Columbia in Vancouver. “Early on using ablation, we had a curative approach and used ablation to ‘clip the wire.’ Now we have growing, objective evidence for ‘debulking’ the problem” working without the need to completely eliminate all AF episodes.
To run the post hoc analysis Dr. Brachmann and his associates categorized the 363 patients randomized in CASTLE-AF by the treatment they received during the study’s first 12 weeks: 150 patients underwent catheter ablation, and 210 received drug treatment, with three patients dropping out. Although this division of the patients diverged from the randomized subgroups, the ablated and drug-treated patients showed no significant differences when compared for several clinical parameters.
Ablation was significantly more effective than drug therapy for cutting atrial fibrillation burden, which started at an average of about 50% in all patients at baseline. AF burden fell to an average of about 10%-15% among the ablated patients when measured at several time points during follow-up, whereas AF burden remained at an average of about 50% or higher among the drug-treated patients.
A receiver operating characteristic analysis showed that change in AF burden after ablation produced a statistically significant 0.66 area-under-the-curve for the primary endpoint, which suggested that reduction in AF burden post ablation could account for about two-thirds of the drop in deaths and hospitalizations for heart failure. Among the nonablated patients the area-under-the-curve was an insignificant 0.49 showing that with drug treatment AF burden had no discernible relationship with outcomes.
One further observation in the new analysis was that a drop in AF burden was linked with improved outcomes regardless of whether or not a “blanking period” was imposed on the data. Researchers applied a 90-day blanking period after ablation when assessing the treatment’s efficacy to censor from the analysis recurrences that occurred soon after ablation. The need for a blanking period during the first 90 days “was put to rest” by this new analysis, Dr. Brachmann said.
CASTLE-AF was sponsored by Biotronik. Dr. Brachmann has been a consultant to and has received research funding from Biotronik and several other companies. Dr. Krahn has been a consultant to Medtronic and has received research support from Medtronic and Boston Scientific. Dr. Link had no disclosures.
SOURCE: Brachmann J et al. Heart Rhythm 2018, Abstract B-LBCT02-04.
This new analysis of data from the CASTLE-AF trial is exciting. It shows that, if we reduce the atrial fibrillation burden when we perform catheter ablation of atrial fibrillation in patients with heart failure, patients do better.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Until now, cardiac electrophysiologists who perform atrial fibrillation (AF) ablation have been too hard on themselves by counting as a failure every patient who develops an AF recurrence that lasts for 30 seconds or more. We know that patients who have a substantial drop in their AF burden after catheter ablation report feeling better even if they continue to have some AF events. When their AF burden drops substantially, patients are better able to work and perform activities of daily life. Many options, including noninvasive devices, are now available to monitor patients’ postablation change in AF burden.
We currently tell patients the success rates of catheter ablation on AF based on recurrence rates. Maybe we need to change our definition of success to a cut in AF burden. Based on these new findings, patients don’t need to be perfect after ablation, with absolutely no recurrences. I have patients who are very happy with their outcome after ablation who still have episodes. The success rate of catheter ablation for treating AF may be much better than we have thought.
Andrea M. Russo, MD , is professor and director of the electrophysiology and arrhythmia service at Cooper University Health Care in Camden, N.J. She made these comments during a press conference and in a video interview. She had no relevant disclosures.
This new analysis of data from the CASTLE-AF trial is exciting. It shows that, if we reduce the atrial fibrillation burden when we perform catheter ablation of atrial fibrillation in patients with heart failure, patients do better.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Until now, cardiac electrophysiologists who perform atrial fibrillation (AF) ablation have been too hard on themselves by counting as a failure every patient who develops an AF recurrence that lasts for 30 seconds or more. We know that patients who have a substantial drop in their AF burden after catheter ablation report feeling better even if they continue to have some AF events. When their AF burden drops substantially, patients are better able to work and perform activities of daily life. Many options, including noninvasive devices, are now available to monitor patients’ postablation change in AF burden.
We currently tell patients the success rates of catheter ablation on AF based on recurrence rates. Maybe we need to change our definition of success to a cut in AF burden. Based on these new findings, patients don’t need to be perfect after ablation, with absolutely no recurrences. I have patients who are very happy with their outcome after ablation who still have episodes. The success rate of catheter ablation for treating AF may be much better than we have thought.
Andrea M. Russo, MD , is professor and director of the electrophysiology and arrhythmia service at Cooper University Health Care in Camden, N.J. She made these comments during a press conference and in a video interview. She had no relevant disclosures.
This new analysis of data from the CASTLE-AF trial is exciting. It shows that, if we reduce the atrial fibrillation burden when we perform catheter ablation of atrial fibrillation in patients with heart failure, patients do better.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Until now, cardiac electrophysiologists who perform atrial fibrillation (AF) ablation have been too hard on themselves by counting as a failure every patient who develops an AF recurrence that lasts for 30 seconds or more. We know that patients who have a substantial drop in their AF burden after catheter ablation report feeling better even if they continue to have some AF events. When their AF burden drops substantially, patients are better able to work and perform activities of daily life. Many options, including noninvasive devices, are now available to monitor patients’ postablation change in AF burden.
We currently tell patients the success rates of catheter ablation on AF based on recurrence rates. Maybe we need to change our definition of success to a cut in AF burden. Based on these new findings, patients don’t need to be perfect after ablation, with absolutely no recurrences. I have patients who are very happy with their outcome after ablation who still have episodes. The success rate of catheter ablation for treating AF may be much better than we have thought.
Andrea M. Russo, MD , is professor and director of the electrophysiology and arrhythmia service at Cooper University Health Care in Camden, N.J. She made these comments during a press conference and in a video interview. She had no relevant disclosures.
BOSTON – From the earliest days of using catheter ablation to treat atrial fibrillation (AF), in the 1990s, clinicians have defined ablation success based on whether patients had recurrence of their arrhythmia following treatment. New findings suggest that this standard was off, and that
The new study used data collected in the CASTLE-AF (Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF) multicenter trial, which compared the efficacy of AF ablation with antiarrhythmic drug treatment in patients with heart failure for improving survival and freedom from hospitalization for heart failure. The trial’s primary finding showed that, in 363 randomized patients, AF ablation cut the primary adverse event rate by 38% relative to antiarrhythmic drug therapy (New Engl J Med. 2018 Feb 1;378[5]:417-27)
“There have been concerns about the high recurrence rate of AF following ablation,” with reported cumulative recurrence rates running as high as 80% by 5 years after ablation, noted Dr. Brachmann. “The news now is that recurrence alone doesn’t make a difference; we can still help patients” by reducing their AF burden, although he cautioned that this relationship has so far only been seen in patients with heart failure with reduced ejection fraction, the type of patients enrolled in CASTLE-AF.
“This information is very informative for clinicians counseling patients who undergo ablation. Ablation may not eliminate all of a patient’s AF, but it will substantially reduce it, and that’s associated with better outcomes,” commented Andrew D. Krahn, MD, professor and chief of cardiology at the University of British Columbia in Vancouver. “Early on using ablation, we had a curative approach and used ablation to ‘clip the wire.’ Now we have growing, objective evidence for ‘debulking’ the problem” working without the need to completely eliminate all AF episodes.
To run the post hoc analysis Dr. Brachmann and his associates categorized the 363 patients randomized in CASTLE-AF by the treatment they received during the study’s first 12 weeks: 150 patients underwent catheter ablation, and 210 received drug treatment, with three patients dropping out. Although this division of the patients diverged from the randomized subgroups, the ablated and drug-treated patients showed no significant differences when compared for several clinical parameters.
Ablation was significantly more effective than drug therapy for cutting atrial fibrillation burden, which started at an average of about 50% in all patients at baseline. AF burden fell to an average of about 10%-15% among the ablated patients when measured at several time points during follow-up, whereas AF burden remained at an average of about 50% or higher among the drug-treated patients.
A receiver operating characteristic analysis showed that change in AF burden after ablation produced a statistically significant 0.66 area-under-the-curve for the primary endpoint, which suggested that reduction in AF burden post ablation could account for about two-thirds of the drop in deaths and hospitalizations for heart failure. Among the nonablated patients the area-under-the-curve was an insignificant 0.49 showing that with drug treatment AF burden had no discernible relationship with outcomes.
One further observation in the new analysis was that a drop in AF burden was linked with improved outcomes regardless of whether or not a “blanking period” was imposed on the data. Researchers applied a 90-day blanking period after ablation when assessing the treatment’s efficacy to censor from the analysis recurrences that occurred soon after ablation. The need for a blanking period during the first 90 days “was put to rest” by this new analysis, Dr. Brachmann said.
CASTLE-AF was sponsored by Biotronik. Dr. Brachmann has been a consultant to and has received research funding from Biotronik and several other companies. Dr. Krahn has been a consultant to Medtronic and has received research support from Medtronic and Boston Scientific. Dr. Link had no disclosures.
SOURCE: Brachmann J et al. Heart Rhythm 2018, Abstract B-LBCT02-04.
BOSTON – From the earliest days of using catheter ablation to treat atrial fibrillation (AF), in the 1990s, clinicians have defined ablation success based on whether patients had recurrence of their arrhythmia following treatment. New findings suggest that this standard was off, and that
The new study used data collected in the CASTLE-AF (Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF) multicenter trial, which compared the efficacy of AF ablation with antiarrhythmic drug treatment in patients with heart failure for improving survival and freedom from hospitalization for heart failure. The trial’s primary finding showed that, in 363 randomized patients, AF ablation cut the primary adverse event rate by 38% relative to antiarrhythmic drug therapy (New Engl J Med. 2018 Feb 1;378[5]:417-27)
“There have been concerns about the high recurrence rate of AF following ablation,” with reported cumulative recurrence rates running as high as 80% by 5 years after ablation, noted Dr. Brachmann. “The news now is that recurrence alone doesn’t make a difference; we can still help patients” by reducing their AF burden, although he cautioned that this relationship has so far only been seen in patients with heart failure with reduced ejection fraction, the type of patients enrolled in CASTLE-AF.
“This information is very informative for clinicians counseling patients who undergo ablation. Ablation may not eliminate all of a patient’s AF, but it will substantially reduce it, and that’s associated with better outcomes,” commented Andrew D. Krahn, MD, professor and chief of cardiology at the University of British Columbia in Vancouver. “Early on using ablation, we had a curative approach and used ablation to ‘clip the wire.’ Now we have growing, objective evidence for ‘debulking’ the problem” working without the need to completely eliminate all AF episodes.
To run the post hoc analysis Dr. Brachmann and his associates categorized the 363 patients randomized in CASTLE-AF by the treatment they received during the study’s first 12 weeks: 150 patients underwent catheter ablation, and 210 received drug treatment, with three patients dropping out. Although this division of the patients diverged from the randomized subgroups, the ablated and drug-treated patients showed no significant differences when compared for several clinical parameters.
Ablation was significantly more effective than drug therapy for cutting atrial fibrillation burden, which started at an average of about 50% in all patients at baseline. AF burden fell to an average of about 10%-15% among the ablated patients when measured at several time points during follow-up, whereas AF burden remained at an average of about 50% or higher among the drug-treated patients.
A receiver operating characteristic analysis showed that change in AF burden after ablation produced a statistically significant 0.66 area-under-the-curve for the primary endpoint, which suggested that reduction in AF burden post ablation could account for about two-thirds of the drop in deaths and hospitalizations for heart failure. Among the nonablated patients the area-under-the-curve was an insignificant 0.49 showing that with drug treatment AF burden had no discernible relationship with outcomes.
One further observation in the new analysis was that a drop in AF burden was linked with improved outcomes regardless of whether or not a “blanking period” was imposed on the data. Researchers applied a 90-day blanking period after ablation when assessing the treatment’s efficacy to censor from the analysis recurrences that occurred soon after ablation. The need for a blanking period during the first 90 days “was put to rest” by this new analysis, Dr. Brachmann said.
CASTLE-AF was sponsored by Biotronik. Dr. Brachmann has been a consultant to and has received research funding from Biotronik and several other companies. Dr. Krahn has been a consultant to Medtronic and has received research support from Medtronic and Boston Scientific. Dr. Link had no disclosures.
SOURCE: Brachmann J et al. Heart Rhythm 2018, Abstract B-LBCT02-04.
REPORTING FROM HEART RHYTHM 2018
Key clinical point: Higher atrial fibrillation (AF) burden was more important than AF recurrence for predicting bad outcomes post ablation.
Major finding: Patients whose AF burden fell to 5% or less had about a threefold higher rate of good outcomes, compared with other patients.
Study details: Post hoc analysis of 360 patients with heart failure and AF enrolled in CASTLE-AF, a multicenter, randomized trial.
Disclosures: CASTLE-AF was sponsored by Biotronik. Dr. Brachmann has been a consultant to and has received research funding from Biotronik and several other companies. Dr. Krahn has been a consultant to Medtronic and has received research support from Medtronic and Boston Scientific. Dr. Link had no disclosures.
Source: Brachmann J et al. Heart Rhythm 2018, Abstract B-LBCT02-04.
Suicide prevention gets ‘standard care’ recommendations
WASHINGTON – The National Action Alliance for Suicide Prevention released in April 2018 what the organization said was the first set of “standard care” recommendations for suicide prevention in people with suicide risk.
Care for people with a suicide risk in the United States “is not working very well. Evidence-based tools exist to detect and manage suicidality, but they are new and infrequently used” by many clinicians, including those seeing suicidal patients in primary care, emergency, or hospital settings, said Michael F. Hogan, PhD, during a session on the new standard-care recommendations at the annual conference of the American Association of Suicidology.
The Action Alliance seeks to have the standard care recommendations widely disseminated and hopes the document will receive endorsement from other organizations, said Dr. Hogan, a health policy consultant in Delmar, N.Y., and a member of the eight-person panel that wrote the recommendations.
These recommendations specify interventions for caregivers in four separate settings: primary care, outpatient behavioral health care (mental health and substance use treatment settings), emergency departments, and behavioral health inpatient care (hospital-level psychiatric or addiction treatment). For each setting, the recommendations highlight one or more core approaches, and then specify standards for identification and assessment, safety planning, means reduction, and follow-up contacts.
For example, within the primary care setting, the recommendations say the goals are to identify suicide risk, enhance the safety for those at risk, refer for specialized care, and provide “caring contacts.” The specifications note that this is achieved with standardized screening and assessment instruments (the recommendations cite eight screening tool options and also suggest three different possible assessment tools); referral as appropriate; a brief safety-planning intervention (the recommendations list five options for this) that includes lethality means reduction along with follow-up to be sure that lethal means have been removed; arranging for rapid follow-up with a mental health professional; and follow-up contact by the primary care clinician within the next 48 hours.
According to Dr. Hogan, a motivation for releasing these recommendations has been the growing U.S. incidence of suicide, rising from 10.4 deaths/100,000 in 2000 to 13.3/100,000 in 2015, a 28% relative increase during a period when the rates of the top killers in the United States – cancer, heart disease, and stroke – were falling. Other telling statistics are that most people who die from suicide had seen a primary care provider during the year before death, and nearly half had seen a primary care provider during the month before their death.
But often the indicators of impending suicide are missed or not acted on. a misperception that contributes to a “failure to ask about suicide risk” on the part of health care professionals, the recommendations said. The document also highlighted the idea that, “most health care professionals are not aware of newly developed brief interventions for suicide, leading to the assumption that they should not ask about suicide because there is nothing practical that can be done in ordinary health care settings.”
One limitation of the recommendations is that they might be interpreted as “standard of care” for medicolegal purposes, warned Alan L. Berman, PhD, during the session’s discussion period. In addition, the evidence base for some of the recommended procedures is not very strong, such as risk stratification, said Dr. Berman, a clinical psychologist and former executive director of the American Association of Suicidology.
Dr. Hogan, Dr. Andrews, and Dr. Berman had no disclosures.
WASHINGTON – The National Action Alliance for Suicide Prevention released in April 2018 what the organization said was the first set of “standard care” recommendations for suicide prevention in people with suicide risk.
Care for people with a suicide risk in the United States “is not working very well. Evidence-based tools exist to detect and manage suicidality, but they are new and infrequently used” by many clinicians, including those seeing suicidal patients in primary care, emergency, or hospital settings, said Michael F. Hogan, PhD, during a session on the new standard-care recommendations at the annual conference of the American Association of Suicidology.
The Action Alliance seeks to have the standard care recommendations widely disseminated and hopes the document will receive endorsement from other organizations, said Dr. Hogan, a health policy consultant in Delmar, N.Y., and a member of the eight-person panel that wrote the recommendations.
These recommendations specify interventions for caregivers in four separate settings: primary care, outpatient behavioral health care (mental health and substance use treatment settings), emergency departments, and behavioral health inpatient care (hospital-level psychiatric or addiction treatment). For each setting, the recommendations highlight one or more core approaches, and then specify standards for identification and assessment, safety planning, means reduction, and follow-up contacts.
For example, within the primary care setting, the recommendations say the goals are to identify suicide risk, enhance the safety for those at risk, refer for specialized care, and provide “caring contacts.” The specifications note that this is achieved with standardized screening and assessment instruments (the recommendations cite eight screening tool options and also suggest three different possible assessment tools); referral as appropriate; a brief safety-planning intervention (the recommendations list five options for this) that includes lethality means reduction along with follow-up to be sure that lethal means have been removed; arranging for rapid follow-up with a mental health professional; and follow-up contact by the primary care clinician within the next 48 hours.
According to Dr. Hogan, a motivation for releasing these recommendations has been the growing U.S. incidence of suicide, rising from 10.4 deaths/100,000 in 2000 to 13.3/100,000 in 2015, a 28% relative increase during a period when the rates of the top killers in the United States – cancer, heart disease, and stroke – were falling. Other telling statistics are that most people who die from suicide had seen a primary care provider during the year before death, and nearly half had seen a primary care provider during the month before their death.
But often the indicators of impending suicide are missed or not acted on. a misperception that contributes to a “failure to ask about suicide risk” on the part of health care professionals, the recommendations said. The document also highlighted the idea that, “most health care professionals are not aware of newly developed brief interventions for suicide, leading to the assumption that they should not ask about suicide because there is nothing practical that can be done in ordinary health care settings.”
One limitation of the recommendations is that they might be interpreted as “standard of care” for medicolegal purposes, warned Alan L. Berman, PhD, during the session’s discussion period. In addition, the evidence base for some of the recommended procedures is not very strong, such as risk stratification, said Dr. Berman, a clinical psychologist and former executive director of the American Association of Suicidology.
Dr. Hogan, Dr. Andrews, and Dr. Berman had no disclosures.
WASHINGTON – The National Action Alliance for Suicide Prevention released in April 2018 what the organization said was the first set of “standard care” recommendations for suicide prevention in people with suicide risk.
Care for people with a suicide risk in the United States “is not working very well. Evidence-based tools exist to detect and manage suicidality, but they are new and infrequently used” by many clinicians, including those seeing suicidal patients in primary care, emergency, or hospital settings, said Michael F. Hogan, PhD, during a session on the new standard-care recommendations at the annual conference of the American Association of Suicidology.
The Action Alliance seeks to have the standard care recommendations widely disseminated and hopes the document will receive endorsement from other organizations, said Dr. Hogan, a health policy consultant in Delmar, N.Y., and a member of the eight-person panel that wrote the recommendations.
These recommendations specify interventions for caregivers in four separate settings: primary care, outpatient behavioral health care (mental health and substance use treatment settings), emergency departments, and behavioral health inpatient care (hospital-level psychiatric or addiction treatment). For each setting, the recommendations highlight one or more core approaches, and then specify standards for identification and assessment, safety planning, means reduction, and follow-up contacts.
For example, within the primary care setting, the recommendations say the goals are to identify suicide risk, enhance the safety for those at risk, refer for specialized care, and provide “caring contacts.” The specifications note that this is achieved with standardized screening and assessment instruments (the recommendations cite eight screening tool options and also suggest three different possible assessment tools); referral as appropriate; a brief safety-planning intervention (the recommendations list five options for this) that includes lethality means reduction along with follow-up to be sure that lethal means have been removed; arranging for rapid follow-up with a mental health professional; and follow-up contact by the primary care clinician within the next 48 hours.
According to Dr. Hogan, a motivation for releasing these recommendations has been the growing U.S. incidence of suicide, rising from 10.4 deaths/100,000 in 2000 to 13.3/100,000 in 2015, a 28% relative increase during a period when the rates of the top killers in the United States – cancer, heart disease, and stroke – were falling. Other telling statistics are that most people who die from suicide had seen a primary care provider during the year before death, and nearly half had seen a primary care provider during the month before their death.
But often the indicators of impending suicide are missed or not acted on. a misperception that contributes to a “failure to ask about suicide risk” on the part of health care professionals, the recommendations said. The document also highlighted the idea that, “most health care professionals are not aware of newly developed brief interventions for suicide, leading to the assumption that they should not ask about suicide because there is nothing practical that can be done in ordinary health care settings.”
One limitation of the recommendations is that they might be interpreted as “standard of care” for medicolegal purposes, warned Alan L. Berman, PhD, during the session’s discussion period. In addition, the evidence base for some of the recommended procedures is not very strong, such as risk stratification, said Dr. Berman, a clinical psychologist and former executive director of the American Association of Suicidology.
Dr. Hogan, Dr. Andrews, and Dr. Berman had no disclosures.
REPORTING FROM THE AAS ANNUAL CONFERENCE
CABANA: AF ablation ties drug management, with an asterisk for crossovers
BOSTON – Results from the CABANA trial, the long-awaited, head-to-head comparison of percutaneous catheter ablation with drug therapy for the treatment of atrial fibrillation by restoring sinus rhythm, failed to accomplish what it was designed to prove.
That is, that catheter ablation was superior to medical management for a combined endpoint of all-cause death, stroke, serious bleeding, or cardiac arrest.
The trial results also gave proponents of catheter ablation some tantalizing hints that this approach actually may have been superior to antiarrhythmic drugs, if only the randomization assignments had been more closely followed as the trial proceeded. But that didn’t happen, with about 30% of patients assigned to medical management crossing over to undergo catheter ablation, presumably because they had received inadequate symptom relief from their drug regimens. In addition, 10% of patients assigned to catheter ablation didn’t undergo it, primarily because they reconsidered after randomization and decided to not choose the invasive option. These crossovers produced a disparity in the outcomes between the standard, intention-to-treat analysis, which showed a neutral difference between the two study arms, and the per-protocol analysis that censored out crossover patients. The per-protocol analysis showed a statistically significant, 27% relative risk reduction in the primary endpoint among the patients randomized to and actually treated with catheter ablation, compared with those randomized to and exclusively treated medically.
“A patient can’t receive benefit from ablation if you don’t ablate,” noted the study’s lead investigation, Douglas L. Packer, MD, as he reported the results at the annual scientific sessions of the Heart Rhythm Society. “When you have this many crossovers and so many patients not getting their assigned treatments, then an on-treatment analysis is required, said Dr. Packer, a cardiac electrophysiologist and professor of medicine at the Mayo Clinic in Rochester, Minn.
The prespecified on-treatment analysis, which, instead of censoring crossover patients, analyzed outcomes based on the treatments that patients actually received, showed a statistically significant one-third reduction in the primary endpoint among the ablated patients and a statistically significant 40% relative reduction in all-cause mortality in the ablated arm, compared with those on medical management.
“For symptomatic treatment, and to restore and maintain sinus rhythm, there is no question that ablation is better. We knew that before this trial, and we know it even more convincingly now,” commented Jeremy N. Ruskin, MD, professor of medicine at Harvard Medical School and director of the cardiac arrhythmia service at Massachusetts General Hospital, both in Boston. “To a large extent, we do ablations for symptomatic benefit; to get patients feeling better. And I think this trial will confirm that because this will likely follow the better reduction in atrial fibrillation burden, which was quite impressive in the study.” Dr. Packer said that the quality of life data collected in CABANA will come out in a report later in 2018.
The dilemma that Dr. Ruskin and other physicians who heard the results voiced was how best to interpret the study’s primary results.
“This trial was designed to address whether ablation has an impact [compared with medical management] on hard endpoints, like mortality, and the intention-to-treat analysis showed no difference. I feel bound to adhere to the intention-to-treat analysis, the primary result” the traditional default arbiter of a randomized trial’s outcome, Dr. Ruskin said in an interview, “But intention-to-treat analyses are built on a foundation where most patients are maintained on their assigned treatment.”
The results “tell us that there wasn’t harm from ablation,” Dr. Albert said during a press conference. “That is really important because, before this, we didn’t know for sure. These data make me a little more confident about offering patients ablation. I now have data to discuss with patients that’s useful for decision making.”
“There was certainly no signal whatsoever of harm by taking patients to ablation early” in their management, agreed Dr. Ruskin. “I find that very reassuring and encouraging.”
CABANA (Catheter Ablation vs. Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial) started in 2009 and enrolled 2,204 patients with documented, new-onset paroxysmal or persistent atrial fibrillation (AF) at 110 centers in 10 countries. Patients averaged about 68 years of age, with about 15% at least 75 years old, and in general were what Dr. Packer characterized as a high-risk group, with a high prevalence of comorbidities: 23% with sleep apnea, 10% with cardiomyopathy, 15% with heart failure, 10% with a prior stroke or transient ischemic attack, and just over a third in a New York Heart Association functional class II or III. About 43% had paroxysmal AF, about 47% had persistent AF, and the remaining patients had long-standing persistent AF. The median duration of AF at the time of entry was just over 1 year.
The clinicians treating the patients assigned to medical management could decide on a case-by-case basis whether to use rate or rhythm control, and about 12% of patients received rate control. The trial design specified pulmonary-vein isolation as the method for left atrial ablation.
In the intention-to-treat analyses, ablation was linked to a 14% relative reduction in the composite primary endpoint, a nonsignificant difference. All-cause mortality was a relative 15% lower in the ablation arm, also not statistically significant. A third prespecified, secondary endpoint, all-cause mortality plus cardiovascular hospitalization, was 17% lower in the ablated patients than in those on drug treatment in the intention-to-treat analysis, a statistically significant difference (P = .002).
The adverse event rate in the ablation arm was “surprisingly” low, said Dr. Packer, with a 3.9% rate of complications from catheter insertion (more than half were hematomas), a 3.4% rate of complications from catheter manipulation within the heart (2.2% involved pericardial effusions that required no intervention), and a 1.8% rate of ablation-related events, most commonly severe pericardial chest pain. “The risks of ablation seem to be lower than we thought,” he said, but quickly added the caveat that all ablation operators in CABANA had to have performed at least 100 ablation cases prior to the trial. The observed safety applies to operators “who know what they’re doing,” he said. Adverse events in the medically treated patients were typical for patients treated with amiodarone, Dr. Packer said, with the most common events hyper- or hypothyroidism, in 1.6%, and an allergic reaction, in 0.6%. In the intention-to-treat analysis the incidence of recurrent AF following a 90-day blanking period after ablation was 47% lower in the ablated patients relative to the drug-treated patients (P less than .0001).
Dr. Packer also presented an intriguing subgroup analysis for the primary endpoint that showed ablation had the best performance relative to medical management in patients younger than 65 years, patients with a history of heart failure, minority patients, and those who entered the trial in NYHA functional class II or III. The subgroup analysis showed a signal for worse performance from ablation in patients who were at least 75 years old. “I’m concerned about these older patients; we need to look into this,” Dr. Packer said. He also expressed optimism that the good performance of ablation in heart failure patients, while an exploratory finding, suggested confirmation of the results reported recently from the CASTLE-AF trial, which also showed good outcomes from catheter ablation for treating patients with heart failure and AF (N Engl J Med. 2018 Feb 1;378[5]:417-27).
The main qualification Dr. Packer voiced about the CABANA results is that not every AF patient should get ablation. “All treatments are not right for all patients. Not everyone with AF needs ablation. You need to talk with patients about it.” But despite this caution, he declared that the results had already changed his practice.
“I much less often now say to patients ‘let’s go with a drug and see what happens.’ I’d still do that if I wasn’t sure that a patient’s symptoms were caused by their AF” as opposed to their underlying heart disease, but if I’m pretty certain that their symptoms are caused by their AF over the past few months, I’ve become more likely to say that front-line ablation is reasonable,” Dr. Packer said.
CABANA received partial funding from Biosense Webster, Boston Scientific, Medtronic, and St. Jude. Dr. Packer has been a consultant to and has received research funding from all four of these companies and also from several other companies. Dr. Ruskin has been a consultant to Biosense Webster and Medtronic and several other companies, has an ownership interest in Amgen, Cameron Health, InfoBionic, Newpace, Portola, and Regeneron, and has a fiduciary role in Pharmaco-Kinesis. Dr. Albert has been a consultant to Myokardia and Sanofi Aventis and has received research funding from Roche Diagnostics and St. Jude.
SOURCE: Packer DL et al. HRS 2018, Abstract B-LBCT01-05.
The data from CABANA suggest that at the least, catheter ablation is the equivalent of drug therapy, and I think in many cases, it is probably superior. Patients with atrial fibrillation should be allowed to undergo ablation as their first treatment, performed by operators who know what they’re doing. These are excellent results, but they do not apply to every patient with atrial fibrillation; they apply to patients like those enrolled in the trial.
The results also speak very loudly about the importance of sinus rhythm in patients with heart failure. The results in the subgroup of patients with heart failure appear to support the findings from CASTLE-AF (N Engl J Med. 2018 Feb 1;378[5]:417-27).
Eric N. Prystowsky, MD , is a cardiac electrophysiologist with the St. Vincent Medical Group in Indianapolis. He has been a consultant to CardioNet and Medtronic, has an equity interest in Stereotaxis, and receives fellowship support from Medtronic and St. Jude. He made these comments as designated discussant for CABANA.
The data from CABANA suggest that at the least, catheter ablation is the equivalent of drug therapy, and I think in many cases, it is probably superior. Patients with atrial fibrillation should be allowed to undergo ablation as their first treatment, performed by operators who know what they’re doing. These are excellent results, but they do not apply to every patient with atrial fibrillation; they apply to patients like those enrolled in the trial.
The results also speak very loudly about the importance of sinus rhythm in patients with heart failure. The results in the subgroup of patients with heart failure appear to support the findings from CASTLE-AF (N Engl J Med. 2018 Feb 1;378[5]:417-27).
Eric N. Prystowsky, MD , is a cardiac electrophysiologist with the St. Vincent Medical Group in Indianapolis. He has been a consultant to CardioNet and Medtronic, has an equity interest in Stereotaxis, and receives fellowship support from Medtronic and St. Jude. He made these comments as designated discussant for CABANA.
The data from CABANA suggest that at the least, catheter ablation is the equivalent of drug therapy, and I think in many cases, it is probably superior. Patients with atrial fibrillation should be allowed to undergo ablation as their first treatment, performed by operators who know what they’re doing. These are excellent results, but they do not apply to every patient with atrial fibrillation; they apply to patients like those enrolled in the trial.
The results also speak very loudly about the importance of sinus rhythm in patients with heart failure. The results in the subgroup of patients with heart failure appear to support the findings from CASTLE-AF (N Engl J Med. 2018 Feb 1;378[5]:417-27).
Eric N. Prystowsky, MD , is a cardiac electrophysiologist with the St. Vincent Medical Group in Indianapolis. He has been a consultant to CardioNet and Medtronic, has an equity interest in Stereotaxis, and receives fellowship support from Medtronic and St. Jude. He made these comments as designated discussant for CABANA.
BOSTON – Results from the CABANA trial, the long-awaited, head-to-head comparison of percutaneous catheter ablation with drug therapy for the treatment of atrial fibrillation by restoring sinus rhythm, failed to accomplish what it was designed to prove.
That is, that catheter ablation was superior to medical management for a combined endpoint of all-cause death, stroke, serious bleeding, or cardiac arrest.
The trial results also gave proponents of catheter ablation some tantalizing hints that this approach actually may have been superior to antiarrhythmic drugs, if only the randomization assignments had been more closely followed as the trial proceeded. But that didn’t happen, with about 30% of patients assigned to medical management crossing over to undergo catheter ablation, presumably because they had received inadequate symptom relief from their drug regimens. In addition, 10% of patients assigned to catheter ablation didn’t undergo it, primarily because they reconsidered after randomization and decided to not choose the invasive option. These crossovers produced a disparity in the outcomes between the standard, intention-to-treat analysis, which showed a neutral difference between the two study arms, and the per-protocol analysis that censored out crossover patients. The per-protocol analysis showed a statistically significant, 27% relative risk reduction in the primary endpoint among the patients randomized to and actually treated with catheter ablation, compared with those randomized to and exclusively treated medically.
“A patient can’t receive benefit from ablation if you don’t ablate,” noted the study’s lead investigation, Douglas L. Packer, MD, as he reported the results at the annual scientific sessions of the Heart Rhythm Society. “When you have this many crossovers and so many patients not getting their assigned treatments, then an on-treatment analysis is required, said Dr. Packer, a cardiac electrophysiologist and professor of medicine at the Mayo Clinic in Rochester, Minn.
The prespecified on-treatment analysis, which, instead of censoring crossover patients, analyzed outcomes based on the treatments that patients actually received, showed a statistically significant one-third reduction in the primary endpoint among the ablated patients and a statistically significant 40% relative reduction in all-cause mortality in the ablated arm, compared with those on medical management.
“For symptomatic treatment, and to restore and maintain sinus rhythm, there is no question that ablation is better. We knew that before this trial, and we know it even more convincingly now,” commented Jeremy N. Ruskin, MD, professor of medicine at Harvard Medical School and director of the cardiac arrhythmia service at Massachusetts General Hospital, both in Boston. “To a large extent, we do ablations for symptomatic benefit; to get patients feeling better. And I think this trial will confirm that because this will likely follow the better reduction in atrial fibrillation burden, which was quite impressive in the study.” Dr. Packer said that the quality of life data collected in CABANA will come out in a report later in 2018.
The dilemma that Dr. Ruskin and other physicians who heard the results voiced was how best to interpret the study’s primary results.
“This trial was designed to address whether ablation has an impact [compared with medical management] on hard endpoints, like mortality, and the intention-to-treat analysis showed no difference. I feel bound to adhere to the intention-to-treat analysis, the primary result” the traditional default arbiter of a randomized trial’s outcome, Dr. Ruskin said in an interview, “But intention-to-treat analyses are built on a foundation where most patients are maintained on their assigned treatment.”
The results “tell us that there wasn’t harm from ablation,” Dr. Albert said during a press conference. “That is really important because, before this, we didn’t know for sure. These data make me a little more confident about offering patients ablation. I now have data to discuss with patients that’s useful for decision making.”
“There was certainly no signal whatsoever of harm by taking patients to ablation early” in their management, agreed Dr. Ruskin. “I find that very reassuring and encouraging.”
CABANA (Catheter Ablation vs. Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial) started in 2009 and enrolled 2,204 patients with documented, new-onset paroxysmal or persistent atrial fibrillation (AF) at 110 centers in 10 countries. Patients averaged about 68 years of age, with about 15% at least 75 years old, and in general were what Dr. Packer characterized as a high-risk group, with a high prevalence of comorbidities: 23% with sleep apnea, 10% with cardiomyopathy, 15% with heart failure, 10% with a prior stroke or transient ischemic attack, and just over a third in a New York Heart Association functional class II or III. About 43% had paroxysmal AF, about 47% had persistent AF, and the remaining patients had long-standing persistent AF. The median duration of AF at the time of entry was just over 1 year.
The clinicians treating the patients assigned to medical management could decide on a case-by-case basis whether to use rate or rhythm control, and about 12% of patients received rate control. The trial design specified pulmonary-vein isolation as the method for left atrial ablation.
In the intention-to-treat analyses, ablation was linked to a 14% relative reduction in the composite primary endpoint, a nonsignificant difference. All-cause mortality was a relative 15% lower in the ablation arm, also not statistically significant. A third prespecified, secondary endpoint, all-cause mortality plus cardiovascular hospitalization, was 17% lower in the ablated patients than in those on drug treatment in the intention-to-treat analysis, a statistically significant difference (P = .002).
The adverse event rate in the ablation arm was “surprisingly” low, said Dr. Packer, with a 3.9% rate of complications from catheter insertion (more than half were hematomas), a 3.4% rate of complications from catheter manipulation within the heart (2.2% involved pericardial effusions that required no intervention), and a 1.8% rate of ablation-related events, most commonly severe pericardial chest pain. “The risks of ablation seem to be lower than we thought,” he said, but quickly added the caveat that all ablation operators in CABANA had to have performed at least 100 ablation cases prior to the trial. The observed safety applies to operators “who know what they’re doing,” he said. Adverse events in the medically treated patients were typical for patients treated with amiodarone, Dr. Packer said, with the most common events hyper- or hypothyroidism, in 1.6%, and an allergic reaction, in 0.6%. In the intention-to-treat analysis the incidence of recurrent AF following a 90-day blanking period after ablation was 47% lower in the ablated patients relative to the drug-treated patients (P less than .0001).
Dr. Packer also presented an intriguing subgroup analysis for the primary endpoint that showed ablation had the best performance relative to medical management in patients younger than 65 years, patients with a history of heart failure, minority patients, and those who entered the trial in NYHA functional class II or III. The subgroup analysis showed a signal for worse performance from ablation in patients who were at least 75 years old. “I’m concerned about these older patients; we need to look into this,” Dr. Packer said. He also expressed optimism that the good performance of ablation in heart failure patients, while an exploratory finding, suggested confirmation of the results reported recently from the CASTLE-AF trial, which also showed good outcomes from catheter ablation for treating patients with heart failure and AF (N Engl J Med. 2018 Feb 1;378[5]:417-27).
The main qualification Dr. Packer voiced about the CABANA results is that not every AF patient should get ablation. “All treatments are not right for all patients. Not everyone with AF needs ablation. You need to talk with patients about it.” But despite this caution, he declared that the results had already changed his practice.
“I much less often now say to patients ‘let’s go with a drug and see what happens.’ I’d still do that if I wasn’t sure that a patient’s symptoms were caused by their AF” as opposed to their underlying heart disease, but if I’m pretty certain that their symptoms are caused by their AF over the past few months, I’ve become more likely to say that front-line ablation is reasonable,” Dr. Packer said.
CABANA received partial funding from Biosense Webster, Boston Scientific, Medtronic, and St. Jude. Dr. Packer has been a consultant to and has received research funding from all four of these companies and also from several other companies. Dr. Ruskin has been a consultant to Biosense Webster and Medtronic and several other companies, has an ownership interest in Amgen, Cameron Health, InfoBionic, Newpace, Portola, and Regeneron, and has a fiduciary role in Pharmaco-Kinesis. Dr. Albert has been a consultant to Myokardia and Sanofi Aventis and has received research funding from Roche Diagnostics and St. Jude.
SOURCE: Packer DL et al. HRS 2018, Abstract B-LBCT01-05.
BOSTON – Results from the CABANA trial, the long-awaited, head-to-head comparison of percutaneous catheter ablation with drug therapy for the treatment of atrial fibrillation by restoring sinus rhythm, failed to accomplish what it was designed to prove.
That is, that catheter ablation was superior to medical management for a combined endpoint of all-cause death, stroke, serious bleeding, or cardiac arrest.
The trial results also gave proponents of catheter ablation some tantalizing hints that this approach actually may have been superior to antiarrhythmic drugs, if only the randomization assignments had been more closely followed as the trial proceeded. But that didn’t happen, with about 30% of patients assigned to medical management crossing over to undergo catheter ablation, presumably because they had received inadequate symptom relief from their drug regimens. In addition, 10% of patients assigned to catheter ablation didn’t undergo it, primarily because they reconsidered after randomization and decided to not choose the invasive option. These crossovers produced a disparity in the outcomes between the standard, intention-to-treat analysis, which showed a neutral difference between the two study arms, and the per-protocol analysis that censored out crossover patients. The per-protocol analysis showed a statistically significant, 27% relative risk reduction in the primary endpoint among the patients randomized to and actually treated with catheter ablation, compared with those randomized to and exclusively treated medically.
“A patient can’t receive benefit from ablation if you don’t ablate,” noted the study’s lead investigation, Douglas L. Packer, MD, as he reported the results at the annual scientific sessions of the Heart Rhythm Society. “When you have this many crossovers and so many patients not getting their assigned treatments, then an on-treatment analysis is required, said Dr. Packer, a cardiac electrophysiologist and professor of medicine at the Mayo Clinic in Rochester, Minn.
The prespecified on-treatment analysis, which, instead of censoring crossover patients, analyzed outcomes based on the treatments that patients actually received, showed a statistically significant one-third reduction in the primary endpoint among the ablated patients and a statistically significant 40% relative reduction in all-cause mortality in the ablated arm, compared with those on medical management.
“For symptomatic treatment, and to restore and maintain sinus rhythm, there is no question that ablation is better. We knew that before this trial, and we know it even more convincingly now,” commented Jeremy N. Ruskin, MD, professor of medicine at Harvard Medical School and director of the cardiac arrhythmia service at Massachusetts General Hospital, both in Boston. “To a large extent, we do ablations for symptomatic benefit; to get patients feeling better. And I think this trial will confirm that because this will likely follow the better reduction in atrial fibrillation burden, which was quite impressive in the study.” Dr. Packer said that the quality of life data collected in CABANA will come out in a report later in 2018.
The dilemma that Dr. Ruskin and other physicians who heard the results voiced was how best to interpret the study’s primary results.
“This trial was designed to address whether ablation has an impact [compared with medical management] on hard endpoints, like mortality, and the intention-to-treat analysis showed no difference. I feel bound to adhere to the intention-to-treat analysis, the primary result” the traditional default arbiter of a randomized trial’s outcome, Dr. Ruskin said in an interview, “But intention-to-treat analyses are built on a foundation where most patients are maintained on their assigned treatment.”
The results “tell us that there wasn’t harm from ablation,” Dr. Albert said during a press conference. “That is really important because, before this, we didn’t know for sure. These data make me a little more confident about offering patients ablation. I now have data to discuss with patients that’s useful for decision making.”
“There was certainly no signal whatsoever of harm by taking patients to ablation early” in their management, agreed Dr. Ruskin. “I find that very reassuring and encouraging.”
CABANA (Catheter Ablation vs. Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial) started in 2009 and enrolled 2,204 patients with documented, new-onset paroxysmal or persistent atrial fibrillation (AF) at 110 centers in 10 countries. Patients averaged about 68 years of age, with about 15% at least 75 years old, and in general were what Dr. Packer characterized as a high-risk group, with a high prevalence of comorbidities: 23% with sleep apnea, 10% with cardiomyopathy, 15% with heart failure, 10% with a prior stroke or transient ischemic attack, and just over a third in a New York Heart Association functional class II or III. About 43% had paroxysmal AF, about 47% had persistent AF, and the remaining patients had long-standing persistent AF. The median duration of AF at the time of entry was just over 1 year.
The clinicians treating the patients assigned to medical management could decide on a case-by-case basis whether to use rate or rhythm control, and about 12% of patients received rate control. The trial design specified pulmonary-vein isolation as the method for left atrial ablation.
In the intention-to-treat analyses, ablation was linked to a 14% relative reduction in the composite primary endpoint, a nonsignificant difference. All-cause mortality was a relative 15% lower in the ablation arm, also not statistically significant. A third prespecified, secondary endpoint, all-cause mortality plus cardiovascular hospitalization, was 17% lower in the ablated patients than in those on drug treatment in the intention-to-treat analysis, a statistically significant difference (P = .002).
The adverse event rate in the ablation arm was “surprisingly” low, said Dr. Packer, with a 3.9% rate of complications from catheter insertion (more than half were hematomas), a 3.4% rate of complications from catheter manipulation within the heart (2.2% involved pericardial effusions that required no intervention), and a 1.8% rate of ablation-related events, most commonly severe pericardial chest pain. “The risks of ablation seem to be lower than we thought,” he said, but quickly added the caveat that all ablation operators in CABANA had to have performed at least 100 ablation cases prior to the trial. The observed safety applies to operators “who know what they’re doing,” he said. Adverse events in the medically treated patients were typical for patients treated with amiodarone, Dr. Packer said, with the most common events hyper- or hypothyroidism, in 1.6%, and an allergic reaction, in 0.6%. In the intention-to-treat analysis the incidence of recurrent AF following a 90-day blanking period after ablation was 47% lower in the ablated patients relative to the drug-treated patients (P less than .0001).
Dr. Packer also presented an intriguing subgroup analysis for the primary endpoint that showed ablation had the best performance relative to medical management in patients younger than 65 years, patients with a history of heart failure, minority patients, and those who entered the trial in NYHA functional class II or III. The subgroup analysis showed a signal for worse performance from ablation in patients who were at least 75 years old. “I’m concerned about these older patients; we need to look into this,” Dr. Packer said. He also expressed optimism that the good performance of ablation in heart failure patients, while an exploratory finding, suggested confirmation of the results reported recently from the CASTLE-AF trial, which also showed good outcomes from catheter ablation for treating patients with heart failure and AF (N Engl J Med. 2018 Feb 1;378[5]:417-27).
The main qualification Dr. Packer voiced about the CABANA results is that not every AF patient should get ablation. “All treatments are not right for all patients. Not everyone with AF needs ablation. You need to talk with patients about it.” But despite this caution, he declared that the results had already changed his practice.
“I much less often now say to patients ‘let’s go with a drug and see what happens.’ I’d still do that if I wasn’t sure that a patient’s symptoms were caused by their AF” as opposed to their underlying heart disease, but if I’m pretty certain that their symptoms are caused by their AF over the past few months, I’ve become more likely to say that front-line ablation is reasonable,” Dr. Packer said.
CABANA received partial funding from Biosense Webster, Boston Scientific, Medtronic, and St. Jude. Dr. Packer has been a consultant to and has received research funding from all four of these companies and also from several other companies. Dr. Ruskin has been a consultant to Biosense Webster and Medtronic and several other companies, has an ownership interest in Amgen, Cameron Health, InfoBionic, Newpace, Portola, and Regeneron, and has a fiduciary role in Pharmaco-Kinesis. Dr. Albert has been a consultant to Myokardia and Sanofi Aventis and has received research funding from Roche Diagnostics and St. Jude.
SOURCE: Packer DL et al. HRS 2018, Abstract B-LBCT01-05.
REPORTING FROM HEART RHYTHM 2018
Key clinical point: Catheter atrial fib ablation showed no significant benefit over medical management for the CABANA’s primary endpoint.
Major finding: The composite endpoint that included all-cause death was a nonsignificant 14% lower with ablation than with medical management in the intention-to-treat analysis.
Study details: CABANA, a multicenter, randomized trial with 2,204 patients.
Disclosures: CABANA received partial funding from Biosense Webster, Boston Scientific, Medtronic, and St. Jude. Dr. Packer has been a consultant to and has received research funding from all four of these companies and from several other companies. Dr. Ruskin has been a consultant to Biosense Webster and Medtronic and several other companies, has an ownership interest in Amgen, Cameron Health, InfoBionic, Newpace, Portola, and Regeneron, and has a fiduciary role in Pharmaco-Kinesis. Dr. Albert has been a consultant to Myokardia and Sanofi-Aventis and has received research funding from Roche Diagnostics and St. Jude.
Source: Packer D et al. HRS 2018, Abstract B-LBCT01-05.
U.S. public largely ignores firearm access and suicide completion link
WASHINGTON – The evidence linking firearm access and suicide completion is largely ignored in current U.S. discussions on guns, Michael D. Anestis, PhD, said at the annual conference of the American Association of Suicidology.
“Only a tiny fraction of media discussions on gun deaths involve suicide. We must make a concerted and sustained effort to change this conversation,” said Dr. Anestis, a clinical psychologist at the University of Southern Mississippi in Hattiesburg. When the relationship between firearms and suicide is discussed, it often is as a “footnote” and includes a lot of inaccurate information.
Dr. Anestis reviewed results from a survey he and his associates ran in 2017 that documented these inaccurate beliefs regarding firearms and suicide. The researchers had 300 American adults who owned at least one firearm complete a questionnaire on their practices for firearm storage and their beliefs on the connections between firearm storage and suicide risk. The results showed a clear link between unsafe firearm storage and reduced belief of a link between firearm access and suicide risk (J Affect Disord. 2018 Feb;227:530-5). They also showed that fearlessness about death moderated the relationship: People with a higher level of fearlessness showed a tighter link between storage practices and beliefs about suicide risk.
During the conference, Dr. Anestis and his associates reported additional, as-yet unpublished findings that further detailed risks for suicide among gun owners. A survey of 100 adults from the Hattiesburg area showed that greater experience firing a gun linked with “factors thought to facilitate the transition from suicidal desire to suicidal behavior. We need to consider an individual’s experience and comfort with firearms, not just ownership and storage,” Dr. Anestis said.
. But additional research from his group showed that another route to acquiring “capability” for suicide, such as fearlessness of death, can occur through exposure to violent video games.
Dr. Anestis had no disclosures.
;
WASHINGTON – The evidence linking firearm access and suicide completion is largely ignored in current U.S. discussions on guns, Michael D. Anestis, PhD, said at the annual conference of the American Association of Suicidology.
“Only a tiny fraction of media discussions on gun deaths involve suicide. We must make a concerted and sustained effort to change this conversation,” said Dr. Anestis, a clinical psychologist at the University of Southern Mississippi in Hattiesburg. When the relationship between firearms and suicide is discussed, it often is as a “footnote” and includes a lot of inaccurate information.
Dr. Anestis reviewed results from a survey he and his associates ran in 2017 that documented these inaccurate beliefs regarding firearms and suicide. The researchers had 300 American adults who owned at least one firearm complete a questionnaire on their practices for firearm storage and their beliefs on the connections between firearm storage and suicide risk. The results showed a clear link between unsafe firearm storage and reduced belief of a link between firearm access and suicide risk (J Affect Disord. 2018 Feb;227:530-5). They also showed that fearlessness about death moderated the relationship: People with a higher level of fearlessness showed a tighter link between storage practices and beliefs about suicide risk.
During the conference, Dr. Anestis and his associates reported additional, as-yet unpublished findings that further detailed risks for suicide among gun owners. A survey of 100 adults from the Hattiesburg area showed that greater experience firing a gun linked with “factors thought to facilitate the transition from suicidal desire to suicidal behavior. We need to consider an individual’s experience and comfort with firearms, not just ownership and storage,” Dr. Anestis said.
. But additional research from his group showed that another route to acquiring “capability” for suicide, such as fearlessness of death, can occur through exposure to violent video games.
Dr. Anestis had no disclosures.
;
WASHINGTON – The evidence linking firearm access and suicide completion is largely ignored in current U.S. discussions on guns, Michael D. Anestis, PhD, said at the annual conference of the American Association of Suicidology.
“Only a tiny fraction of media discussions on gun deaths involve suicide. We must make a concerted and sustained effort to change this conversation,” said Dr. Anestis, a clinical psychologist at the University of Southern Mississippi in Hattiesburg. When the relationship between firearms and suicide is discussed, it often is as a “footnote” and includes a lot of inaccurate information.
Dr. Anestis reviewed results from a survey he and his associates ran in 2017 that documented these inaccurate beliefs regarding firearms and suicide. The researchers had 300 American adults who owned at least one firearm complete a questionnaire on their practices for firearm storage and their beliefs on the connections between firearm storage and suicide risk. The results showed a clear link between unsafe firearm storage and reduced belief of a link between firearm access and suicide risk (J Affect Disord. 2018 Feb;227:530-5). They also showed that fearlessness about death moderated the relationship: People with a higher level of fearlessness showed a tighter link between storage practices and beliefs about suicide risk.
During the conference, Dr. Anestis and his associates reported additional, as-yet unpublished findings that further detailed risks for suicide among gun owners. A survey of 100 adults from the Hattiesburg area showed that greater experience firing a gun linked with “factors thought to facilitate the transition from suicidal desire to suicidal behavior. We need to consider an individual’s experience and comfort with firearms, not just ownership and storage,” Dr. Anestis said.
. But additional research from his group showed that another route to acquiring “capability” for suicide, such as fearlessness of death, can occur through exposure to violent video games.
Dr. Anestis had no disclosures.
;
REPORTING FROM THE AAS ANNUAL CONFERENCE
Thirty-second atrial fib threshold may drive overdiagnosis
BOSTON – The standard definition of an episode of atrial fibrillation is a fibrillation event that lasts at least 30 seconds, but a new analysis of monitoring data collected from 615 patients showed that this threshold can label many patients as having atrial fibrillation despite an extremely low disease burden.
A more clinically relevant definition of atrial fibrillation (AF) might be a patient with at least one episode that persists for at least 3.8 hours, because this threshold identified people with a median AF burden of just under 10%, Jonathan S. Steinberg, MD, said while presenting a poster at the annual scientific sessions of the Heart Rhythm Society.
The 30-second threshold for defining an AF episode dates from the early days of atrial ablation treatment, when researchers tracked ablated patients for signs of AF recurrence. But this definition that clinicians devised for a very select subgroup of AF patients subsequently “metastasized” to define AF in all settings, he noted. As one recent example, the 2017 consensus document on screening for AF in asymptomatic people defined asymptomatic patients as having AF if they had at least one 30-second event picked up on an ECG recording (EP Europace. 2017 Oct 1;19[10]:1589-623).
“How we define AF is very important as we look for it in asymptomatic people,” Dr. Steinberg said in an interview.
A better definition of AF might depend on total AF burden, which is the percentage of time the patient’s atrium spends fibrillating. But it’s impossible to directly measure AF burden over a reasonably representative period of time without having an implanted device. If AF is monitored with an external device, the sampling time will be relatively brief, and so the AF assessment needs to rely on a surrogate for AF burden: the longest duration of any measured AF episode.
“No prior AF database has been analyzed like we have,” to correlate AF burden with the duration of the longest AF episode, Dr. Steinberg said.
He and his associates used data collected by Medtronic from 1,040 patients enrolled in a company registry during 2005-2016 with an implanted dual-chamber pacemaker able to detect atrial arrhythmias. The researchers focused on the 615 patients who had AF detected during at least 30 days of monitoring. These 615 patients averaged 72 years of age, 54% were men, and 599 had at least one AF episode of at least 30 seconds duration. Each patient had an average 3.7-year accumulated archive of atrial rhythm data.
The analysis showed a close association between the longest AF episode detected and overall AF burden. Among patients with a longest episode of 30-119 seconds, the median burden was 0.1%. Among patients with a maximum duration of anywhere from 30 seconds to 3.7 hours, the median burden was 0.2%. But among people with a longest episode of 3.8 hours to 5.4 hours, the median burden was 1.2%. In those with a longest episode of at least 24 hours, the median burden was 25%. Finally, in those who had a longest AF episode that lasted at least 3.8 hours, the median AF burden was 9.5%.
Dr. Steinberg acknowledged that a very important additional step needed in this analysis is examining the correlations among AF burden, longest AF episode, and stroke incidence, something he and his associates are now doing. He expressed hope that these data will spur the cardiac electrophysiology community to rethink its AF definition.
The study was funded by Medtronic. Dr. Steinberg has been a consultant and/or has received research funding from Medtronic, AliveCor, Allergen, Atricure, Biosense Webster, G Medical, and National Cardiac. Several of his coauthors were Medtronic employees.
SOURCE: Steinberg J et al. Heart Rhythm Society scientific sessions, B-P001-062.
BOSTON – The standard definition of an episode of atrial fibrillation is a fibrillation event that lasts at least 30 seconds, but a new analysis of monitoring data collected from 615 patients showed that this threshold can label many patients as having atrial fibrillation despite an extremely low disease burden.
A more clinically relevant definition of atrial fibrillation (AF) might be a patient with at least one episode that persists for at least 3.8 hours, because this threshold identified people with a median AF burden of just under 10%, Jonathan S. Steinberg, MD, said while presenting a poster at the annual scientific sessions of the Heart Rhythm Society.
The 30-second threshold for defining an AF episode dates from the early days of atrial ablation treatment, when researchers tracked ablated patients for signs of AF recurrence. But this definition that clinicians devised for a very select subgroup of AF patients subsequently “metastasized” to define AF in all settings, he noted. As one recent example, the 2017 consensus document on screening for AF in asymptomatic people defined asymptomatic patients as having AF if they had at least one 30-second event picked up on an ECG recording (EP Europace. 2017 Oct 1;19[10]:1589-623).
“How we define AF is very important as we look for it in asymptomatic people,” Dr. Steinberg said in an interview.
A better definition of AF might depend on total AF burden, which is the percentage of time the patient’s atrium spends fibrillating. But it’s impossible to directly measure AF burden over a reasonably representative period of time without having an implanted device. If AF is monitored with an external device, the sampling time will be relatively brief, and so the AF assessment needs to rely on a surrogate for AF burden: the longest duration of any measured AF episode.
“No prior AF database has been analyzed like we have,” to correlate AF burden with the duration of the longest AF episode, Dr. Steinberg said.
He and his associates used data collected by Medtronic from 1,040 patients enrolled in a company registry during 2005-2016 with an implanted dual-chamber pacemaker able to detect atrial arrhythmias. The researchers focused on the 615 patients who had AF detected during at least 30 days of monitoring. These 615 patients averaged 72 years of age, 54% were men, and 599 had at least one AF episode of at least 30 seconds duration. Each patient had an average 3.7-year accumulated archive of atrial rhythm data.
The analysis showed a close association between the longest AF episode detected and overall AF burden. Among patients with a longest episode of 30-119 seconds, the median burden was 0.1%. Among patients with a maximum duration of anywhere from 30 seconds to 3.7 hours, the median burden was 0.2%. But among people with a longest episode of 3.8 hours to 5.4 hours, the median burden was 1.2%. In those with a longest episode of at least 24 hours, the median burden was 25%. Finally, in those who had a longest AF episode that lasted at least 3.8 hours, the median AF burden was 9.5%.
Dr. Steinberg acknowledged that a very important additional step needed in this analysis is examining the correlations among AF burden, longest AF episode, and stroke incidence, something he and his associates are now doing. He expressed hope that these data will spur the cardiac electrophysiology community to rethink its AF definition.
The study was funded by Medtronic. Dr. Steinberg has been a consultant and/or has received research funding from Medtronic, AliveCor, Allergen, Atricure, Biosense Webster, G Medical, and National Cardiac. Several of his coauthors were Medtronic employees.
SOURCE: Steinberg J et al. Heart Rhythm Society scientific sessions, B-P001-062.
BOSTON – The standard definition of an episode of atrial fibrillation is a fibrillation event that lasts at least 30 seconds, but a new analysis of monitoring data collected from 615 patients showed that this threshold can label many patients as having atrial fibrillation despite an extremely low disease burden.
A more clinically relevant definition of atrial fibrillation (AF) might be a patient with at least one episode that persists for at least 3.8 hours, because this threshold identified people with a median AF burden of just under 10%, Jonathan S. Steinberg, MD, said while presenting a poster at the annual scientific sessions of the Heart Rhythm Society.
The 30-second threshold for defining an AF episode dates from the early days of atrial ablation treatment, when researchers tracked ablated patients for signs of AF recurrence. But this definition that clinicians devised for a very select subgroup of AF patients subsequently “metastasized” to define AF in all settings, he noted. As one recent example, the 2017 consensus document on screening for AF in asymptomatic people defined asymptomatic patients as having AF if they had at least one 30-second event picked up on an ECG recording (EP Europace. 2017 Oct 1;19[10]:1589-623).
“How we define AF is very important as we look for it in asymptomatic people,” Dr. Steinberg said in an interview.
A better definition of AF might depend on total AF burden, which is the percentage of time the patient’s atrium spends fibrillating. But it’s impossible to directly measure AF burden over a reasonably representative period of time without having an implanted device. If AF is monitored with an external device, the sampling time will be relatively brief, and so the AF assessment needs to rely on a surrogate for AF burden: the longest duration of any measured AF episode.
“No prior AF database has been analyzed like we have,” to correlate AF burden with the duration of the longest AF episode, Dr. Steinberg said.
He and his associates used data collected by Medtronic from 1,040 patients enrolled in a company registry during 2005-2016 with an implanted dual-chamber pacemaker able to detect atrial arrhythmias. The researchers focused on the 615 patients who had AF detected during at least 30 days of monitoring. These 615 patients averaged 72 years of age, 54% were men, and 599 had at least one AF episode of at least 30 seconds duration. Each patient had an average 3.7-year accumulated archive of atrial rhythm data.
The analysis showed a close association between the longest AF episode detected and overall AF burden. Among patients with a longest episode of 30-119 seconds, the median burden was 0.1%. Among patients with a maximum duration of anywhere from 30 seconds to 3.7 hours, the median burden was 0.2%. But among people with a longest episode of 3.8 hours to 5.4 hours, the median burden was 1.2%. In those with a longest episode of at least 24 hours, the median burden was 25%. Finally, in those who had a longest AF episode that lasted at least 3.8 hours, the median AF burden was 9.5%.
Dr. Steinberg acknowledged that a very important additional step needed in this analysis is examining the correlations among AF burden, longest AF episode, and stroke incidence, something he and his associates are now doing. He expressed hope that these data will spur the cardiac electrophysiology community to rethink its AF definition.
The study was funded by Medtronic. Dr. Steinberg has been a consultant and/or has received research funding from Medtronic, AliveCor, Allergen, Atricure, Biosense Webster, G Medical, and National Cardiac. Several of his coauthors were Medtronic employees.
SOURCE: Steinberg J et al. Heart Rhythm Society scientific sessions, B-P001-062.
REPORTING FROM HEART RHYTHM 2018
Key clinical point:
Major finding: The median atrial fibrillation burden was 0.1% when the longest AF episode was 30-119 seconds.
Study details: Review of data from 615 patients with AF events in a Medtronic registry.
Disclosures: Medtronic funded the study. Dr. Steinberg has been a consultant and/or has received research funding from Medtronic, AliveCor, Allergen, Atricure, Biosense Webster, G Medical, and National Cardiac. Several of his coauthors were Medtronic employees.
Source: Steinberg J et al. Heart Rhythm Society scientific sessions B-P001-062.