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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
Babies exposed to SSRIs in utero have decreased LV size
TORONTO – according to a small study presented at the Pediatric Academic Societies annual meeting.
“Given the frequency of SSRI use during pregnancy and continued conflicting results regarding cardiac effects, it is an important area of study,” senior author Sarah Haskell, DO, said in an interview. Her group at the University of Iowa in Coralville, which includes first author Deidra Ansah, MD, previously demonstrated reduced ventricular size and cardiac function in sertraline-exposed animal models.
Compared with unexposed newborns, SSRI-exposed infants had a 16% reduction in right ventricular (RV) diameter in diastole (P = .02) and a 22% reduction in left ventricular (LV) volume in systole (P = .02). They also had decreased LV lengths in diastole and systole (P = .045 and .004, respectively), but no impact was noted on cardiac function, as measured by shortening fraction.
“While cardiac function was appropriate on the initial echocardiogram, there were significant differences in cardiac dimensions,” said Dr. Haskell. “Whether these differences influence health and disease susceptibility requires further, longer-term studies.”
Her group plans to continue investigating the effects of SSRIs on cardiac development and also plans to study the offspring of women who are depressed but not on pharmacologic treatment to determine the effects of depression alone on cardiac size and function.
Dr. Haskell and her colleagues studied 21 term infants without and 20 term infants with exposure to in utero SSRIs who underwent standard echocardiograms including four-chamber and M-mode views within 48 hours of life. Exclusion criteria included prematurity, large or small for gestational age, any respiratory or cardiac support, and any major congenital malformations.
The mothers of exposed infants had higher depression scores compared with controls (P = .004), and had minimal to mild depression. Otherwise, they were similar in terms of age, weight, and likelihood of having chronic or gestational hypertension or diabetes. There also were no differences in maternal conditions or infant birth weight, body surface area or gestational age.
In the infants, no differences were seen in the occurrence of patent foramen ovale, patent ductus arteriosus, ventricular septal defect, or peripheral pulmonary artery stenosis.
This research was supported by the Department of Pediatric K12 Child Health Research Career Development Award, the Stead Family Department of Pediatrics at the University of Iowa, an NIH T32 grant, and the Children’s Miracle Network. The authors reported no financial disclosures.
TORONTO – according to a small study presented at the Pediatric Academic Societies annual meeting.
“Given the frequency of SSRI use during pregnancy and continued conflicting results regarding cardiac effects, it is an important area of study,” senior author Sarah Haskell, DO, said in an interview. Her group at the University of Iowa in Coralville, which includes first author Deidra Ansah, MD, previously demonstrated reduced ventricular size and cardiac function in sertraline-exposed animal models.
Compared with unexposed newborns, SSRI-exposed infants had a 16% reduction in right ventricular (RV) diameter in diastole (P = .02) and a 22% reduction in left ventricular (LV) volume in systole (P = .02). They also had decreased LV lengths in diastole and systole (P = .045 and .004, respectively), but no impact was noted on cardiac function, as measured by shortening fraction.
“While cardiac function was appropriate on the initial echocardiogram, there were significant differences in cardiac dimensions,” said Dr. Haskell. “Whether these differences influence health and disease susceptibility requires further, longer-term studies.”
Her group plans to continue investigating the effects of SSRIs on cardiac development and also plans to study the offspring of women who are depressed but not on pharmacologic treatment to determine the effects of depression alone on cardiac size and function.
Dr. Haskell and her colleagues studied 21 term infants without and 20 term infants with exposure to in utero SSRIs who underwent standard echocardiograms including four-chamber and M-mode views within 48 hours of life. Exclusion criteria included prematurity, large or small for gestational age, any respiratory or cardiac support, and any major congenital malformations.
The mothers of exposed infants had higher depression scores compared with controls (P = .004), and had minimal to mild depression. Otherwise, they were similar in terms of age, weight, and likelihood of having chronic or gestational hypertension or diabetes. There also were no differences in maternal conditions or infant birth weight, body surface area or gestational age.
In the infants, no differences were seen in the occurrence of patent foramen ovale, patent ductus arteriosus, ventricular septal defect, or peripheral pulmonary artery stenosis.
This research was supported by the Department of Pediatric K12 Child Health Research Career Development Award, the Stead Family Department of Pediatrics at the University of Iowa, an NIH T32 grant, and the Children’s Miracle Network. The authors reported no financial disclosures.
TORONTO – according to a small study presented at the Pediatric Academic Societies annual meeting.
“Given the frequency of SSRI use during pregnancy and continued conflicting results regarding cardiac effects, it is an important area of study,” senior author Sarah Haskell, DO, said in an interview. Her group at the University of Iowa in Coralville, which includes first author Deidra Ansah, MD, previously demonstrated reduced ventricular size and cardiac function in sertraline-exposed animal models.
Compared with unexposed newborns, SSRI-exposed infants had a 16% reduction in right ventricular (RV) diameter in diastole (P = .02) and a 22% reduction in left ventricular (LV) volume in systole (P = .02). They also had decreased LV lengths in diastole and systole (P = .045 and .004, respectively), but no impact was noted on cardiac function, as measured by shortening fraction.
“While cardiac function was appropriate on the initial echocardiogram, there were significant differences in cardiac dimensions,” said Dr. Haskell. “Whether these differences influence health and disease susceptibility requires further, longer-term studies.”
Her group plans to continue investigating the effects of SSRIs on cardiac development and also plans to study the offspring of women who are depressed but not on pharmacologic treatment to determine the effects of depression alone on cardiac size and function.
Dr. Haskell and her colleagues studied 21 term infants without and 20 term infants with exposure to in utero SSRIs who underwent standard echocardiograms including four-chamber and M-mode views within 48 hours of life. Exclusion criteria included prematurity, large or small for gestational age, any respiratory or cardiac support, and any major congenital malformations.
The mothers of exposed infants had higher depression scores compared with controls (P = .004), and had minimal to mild depression. Otherwise, they were similar in terms of age, weight, and likelihood of having chronic or gestational hypertension or diabetes. There also were no differences in maternal conditions or infant birth weight, body surface area or gestational age.
In the infants, no differences were seen in the occurrence of patent foramen ovale, patent ductus arteriosus, ventricular septal defect, or peripheral pulmonary artery stenosis.
This research was supported by the Department of Pediatric K12 Child Health Research Career Development Award, the Stead Family Department of Pediatrics at the University of Iowa, an NIH T32 grant, and the Children’s Miracle Network. The authors reported no financial disclosures.
AT PAS 2018
Key clinical point: Babies exposed to SSRIs in utero have smaller hearts compared with babies not exposed to SSRIs.
Major finding: Compared with unexposed newborns, SSRI-exposed infants had a 16% reduction in right ventricular diameter in diastole (P = .02) and a 22% reduction in left ventricular volume in systole (P = .02).
Study details: A study of 20 babies exposed to SSRIs in utero and 21 not exposed.
Disclosures: This research was supported by the Department of Pediatric K12 Child Health Research Career Development Award, the Stead Family Department of Pediatrics at the University of Iowa, an NIH T32 grant, and the Children’s Miracle Network. The authors reported no financial disclosures.
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.
Implanted pulse generator ups exercise tolerance in HF
BOSTON – Cardiac contractility modulation (CCM), an electrical device–based modality, may improve exercise tolerance and quality of life in heart failure patients with ejection fraction between 25% and 45%, results of a randomized, controlled trial suggested.
Notably, clinical effectiveness appeared to be even greater in the subset of patient with ejection fractions between 35% and 45%, according to results presented at the annual scientific sessions of the Heart Rhythm Society.
The CCM approach was designed to treat chronic heart failure patients with reduced and midrange ejection fractions. It involves the delivery of electrical signals during the cardiac absolute refractory period to enhance contraction strength. Key components include an atrial lead used for sensing and two ventricular leads used for sensing local electrical activity and delivery of CCM signals.
The device was previously evaluated in FIX-HF-5, a 428-patient randomized trial of CCM in patients with New York Heart Association functional class III/IV and reduced ejection fraction. That study failed to meet its primary efficacy end point, but a subgroup analysis showed significant treatment effects in patients with ejection fractions between 25% and 45%.
Consequently, Dr. Abraham initiated the FIX-HF-5 confirmatory study (FIX-HF-5C) to prospectively evaluate CCM in patients with ejection fractions in that range.
The study included 160 with NYHA class III/IV heart failure, QRS duration less than 130 ms, and ejection fractions of 25%-45% who were randomized either to CCM or to continued optimal medical therapy. The control arm included 86 patients, and the CCM arm included 74 patients, of whom 68 received device implantation.
For evaluating peak VO2, the primary end point of this confirmatory study, investigators used a Bayesian model that allowed them incorporate some data from the corresponding subgroup of patients with ejection fractions between 25% and 45% in the previous FIX-HF-5 randomized trial.
Using this model, they found the mean difference between CCM and medical therapy groups at week 24 was 0.836 mL O2/kg per minute (95% Bayesian credible interval, 0.123-1.552). The probability of CCM treatment’s superiority to control was 0.989, according to investigators, which exceeded the 0.975 threshold for statistical significance.
Dr. Abraham and his coinvestigators found that CCM implantation was safe, with a 90% complication-free rate, and that it improved both quality of life and functional status.
All efficacy endpoints were better in patients with ejection fractions of 35% or greater, confirming the subgroup analysis findings of the previous randomized trial, according to Dr. Abraham and his coinvestigators.
Survival free of cardiac death and heart failure hospitalization at 24 weeks was 97.1% in the CCM arm versus 89.2% in controls, which was a secondary finding that reached statistical significance in favor of CCM (P = .048) in one analysis of Kaplan-Meier estimates, investigators said in their report.
The CCM device could fulfill an unmet need for patients who have persistent heart failure despite optimal, guideline-based medical therapy, according to the investigators.
“Although ICDs are applicable to the broad population of patients with ejection fraction [at least] 35%, they do not deliver a therapy for improving exercise tolerance or quality of life,” they said in their report.
Research grant support for the study came from Impulse Dynamics. Dr. Abraham and several coauthors reported serving as consultants to the company.
SOURCE: Abraham WT et al. JACC Heart Fail. 2018 May 10. doi: 10.1016/j.jchf.2018.04.010.
BOSTON – Cardiac contractility modulation (CCM), an electrical device–based modality, may improve exercise tolerance and quality of life in heart failure patients with ejection fraction between 25% and 45%, results of a randomized, controlled trial suggested.
Notably, clinical effectiveness appeared to be even greater in the subset of patient with ejection fractions between 35% and 45%, according to results presented at the annual scientific sessions of the Heart Rhythm Society.
The CCM approach was designed to treat chronic heart failure patients with reduced and midrange ejection fractions. It involves the delivery of electrical signals during the cardiac absolute refractory period to enhance contraction strength. Key components include an atrial lead used for sensing and two ventricular leads used for sensing local electrical activity and delivery of CCM signals.
The device was previously evaluated in FIX-HF-5, a 428-patient randomized trial of CCM in patients with New York Heart Association functional class III/IV and reduced ejection fraction. That study failed to meet its primary efficacy end point, but a subgroup analysis showed significant treatment effects in patients with ejection fractions between 25% and 45%.
Consequently, Dr. Abraham initiated the FIX-HF-5 confirmatory study (FIX-HF-5C) to prospectively evaluate CCM in patients with ejection fractions in that range.
The study included 160 with NYHA class III/IV heart failure, QRS duration less than 130 ms, and ejection fractions of 25%-45% who were randomized either to CCM or to continued optimal medical therapy. The control arm included 86 patients, and the CCM arm included 74 patients, of whom 68 received device implantation.
For evaluating peak VO2, the primary end point of this confirmatory study, investigators used a Bayesian model that allowed them incorporate some data from the corresponding subgroup of patients with ejection fractions between 25% and 45% in the previous FIX-HF-5 randomized trial.
Using this model, they found the mean difference between CCM and medical therapy groups at week 24 was 0.836 mL O2/kg per minute (95% Bayesian credible interval, 0.123-1.552). The probability of CCM treatment’s superiority to control was 0.989, according to investigators, which exceeded the 0.975 threshold for statistical significance.
Dr. Abraham and his coinvestigators found that CCM implantation was safe, with a 90% complication-free rate, and that it improved both quality of life and functional status.
All efficacy endpoints were better in patients with ejection fractions of 35% or greater, confirming the subgroup analysis findings of the previous randomized trial, according to Dr. Abraham and his coinvestigators.
Survival free of cardiac death and heart failure hospitalization at 24 weeks was 97.1% in the CCM arm versus 89.2% in controls, which was a secondary finding that reached statistical significance in favor of CCM (P = .048) in one analysis of Kaplan-Meier estimates, investigators said in their report.
The CCM device could fulfill an unmet need for patients who have persistent heart failure despite optimal, guideline-based medical therapy, according to the investigators.
“Although ICDs are applicable to the broad population of patients with ejection fraction [at least] 35%, they do not deliver a therapy for improving exercise tolerance or quality of life,” they said in their report.
Research grant support for the study came from Impulse Dynamics. Dr. Abraham and several coauthors reported serving as consultants to the company.
SOURCE: Abraham WT et al. JACC Heart Fail. 2018 May 10. doi: 10.1016/j.jchf.2018.04.010.
BOSTON – Cardiac contractility modulation (CCM), an electrical device–based modality, may improve exercise tolerance and quality of life in heart failure patients with ejection fraction between 25% and 45%, results of a randomized, controlled trial suggested.
Notably, clinical effectiveness appeared to be even greater in the subset of patient with ejection fractions between 35% and 45%, according to results presented at the annual scientific sessions of the Heart Rhythm Society.
The CCM approach was designed to treat chronic heart failure patients with reduced and midrange ejection fractions. It involves the delivery of electrical signals during the cardiac absolute refractory period to enhance contraction strength. Key components include an atrial lead used for sensing and two ventricular leads used for sensing local electrical activity and delivery of CCM signals.
The device was previously evaluated in FIX-HF-5, a 428-patient randomized trial of CCM in patients with New York Heart Association functional class III/IV and reduced ejection fraction. That study failed to meet its primary efficacy end point, but a subgroup analysis showed significant treatment effects in patients with ejection fractions between 25% and 45%.
Consequently, Dr. Abraham initiated the FIX-HF-5 confirmatory study (FIX-HF-5C) to prospectively evaluate CCM in patients with ejection fractions in that range.
The study included 160 with NYHA class III/IV heart failure, QRS duration less than 130 ms, and ejection fractions of 25%-45% who were randomized either to CCM or to continued optimal medical therapy. The control arm included 86 patients, and the CCM arm included 74 patients, of whom 68 received device implantation.
For evaluating peak VO2, the primary end point of this confirmatory study, investigators used a Bayesian model that allowed them incorporate some data from the corresponding subgroup of patients with ejection fractions between 25% and 45% in the previous FIX-HF-5 randomized trial.
Using this model, they found the mean difference between CCM and medical therapy groups at week 24 was 0.836 mL O2/kg per minute (95% Bayesian credible interval, 0.123-1.552). The probability of CCM treatment’s superiority to control was 0.989, according to investigators, which exceeded the 0.975 threshold for statistical significance.
Dr. Abraham and his coinvestigators found that CCM implantation was safe, with a 90% complication-free rate, and that it improved both quality of life and functional status.
All efficacy endpoints were better in patients with ejection fractions of 35% or greater, confirming the subgroup analysis findings of the previous randomized trial, according to Dr. Abraham and his coinvestigators.
Survival free of cardiac death and heart failure hospitalization at 24 weeks was 97.1% in the CCM arm versus 89.2% in controls, which was a secondary finding that reached statistical significance in favor of CCM (P = .048) in one analysis of Kaplan-Meier estimates, investigators said in their report.
The CCM device could fulfill an unmet need for patients who have persistent heart failure despite optimal, guideline-based medical therapy, according to the investigators.
“Although ICDs are applicable to the broad population of patients with ejection fraction [at least] 35%, they do not deliver a therapy for improving exercise tolerance or quality of life,” they said in their report.
Research grant support for the study came from Impulse Dynamics. Dr. Abraham and several coauthors reported serving as consultants to the company.
SOURCE: Abraham WT et al. JACC Heart Fail. 2018 May 10. doi: 10.1016/j.jchf.2018.04.010.
REPORTING FROM HEART RHYTHM 2018
Key clinical point: Compared with continued medical therapy, cardiac contractility modulation (CCM) improved exercise tolerance and quality of life in heart failure patients with ejection fraction between 25% and 45%.
Major finding: The difference in peak VO2 between study arms was 0.836 mL O2/kg per minute (95% Bayesian credible interval, 0.123-1.552).
Study details: A randomized controlled trial including 160 patients with NYHA class III/IV heart failure and ejection fraction between 25% and 45%.
Disclosures: Research grant support for the study came from Impulse Dynamics. Several study authors reported serving as consultants to Impulse Dynamics.
Source: Abraham WT et al. JACC Heart Fail. 2018 May 10. doi: 10.1016/j.jchf.2018.04.010.
Lower glucose target linked to improved mortality in critically ill
compared with patients with a target of 90-140 mg/dL, according to results of a retrospective cohort analysis.
With the computerized intravenous insulin protocol used in the study, the strict target could be achieved with a low rate of hypoglycemia, the authors wrote. The analysis was published in the journal CHEST®.
However, it does raise the possibility that earlier investigations finding an association between intensive insulin therapy and excess mortality “may have been accurate only in the setting of technologies which led to high rates of severe hypoglycemia,” they wrote.
The retrospective cohort analysis by Dr. Hersh and his colleagues included 1,809 adult patients treated at three different ICUs in two hospitals between January 2010 and December 2015. Treatment was delivered with a computerized ICU insulin infusion protocol that allows clinicians to choose between two blood glucose targets: 80-110 mg/dL or 90-140 mg/dL. The lower target was chosen for 951 patients, and the moderate target for 858 patients.
The most common primary admission diagnoses in the cohort included chest pain or acute coronary syndrome in 43.3%, cardiothoracic surgery in 31.9%, heart failure (including cardiogenic shock) in 6.8%, and vascular surgery in 6.0%.
While patients in the low blood glucose target group had a higher rate of moderate hypoglycemia, both groups had a low rate of severe hypoglycemia, at 1.16% in the low target group and 0.35% in the moderate target group (P = .051).
Unadjusted 30-day mortality was significantly lower in the 80-110–mg/dL group compared with the 90-140–mg/dL group (4.3% vs. 9.2%, respectively; P less than .001), according to the investigators.
Furthermore, logistic regression analysis showed that patients treated with a target of 80-110 mg/dL had a lower risk of 30-day mortality compared with patients with a target of 90-140 mg/dL (odds ratio 0.65; 95% confidence interval, 0.43-0.98; P = .04).
These results advance the debate over appropriate blood glucose targets in critically ill patients, as they suggest that the effects of targeting blood glucose and the effects of severe hypoglycemia “can be separated,” the investigators wrote.
Current guidelines on intensive insulin therapy are based in part on findings of the NICE-SUGAR trial, which found that among adults treated in the ICU, intensive glucose control increased mortality. However, a post hoc analysis suggested the mortality increase in NICE-SUGAR was “largely driven by a significant incidence of moderate hypoglycemia, and to a greater degree severe hypoglycemia,” Dr. Hersh and his coauthors noted in their report.
“Given improvements in insulin delivery and glucose monitoring, a reassessment of potential benefits of [intensive insulin therapy] should once again be evaluated in a prospective randomized trial,” they wrote.
Dr. Hersh and his coauthors declared no financial or nonfinancial disclosures related to the study.
SOURCE: Hersh AM et al. CHEST 2018. doi: 10.1016/j.chest.2018.04.025.
compared with patients with a target of 90-140 mg/dL, according to results of a retrospective cohort analysis.
With the computerized intravenous insulin protocol used in the study, the strict target could be achieved with a low rate of hypoglycemia, the authors wrote. The analysis was published in the journal CHEST®.
However, it does raise the possibility that earlier investigations finding an association between intensive insulin therapy and excess mortality “may have been accurate only in the setting of technologies which led to high rates of severe hypoglycemia,” they wrote.
The retrospective cohort analysis by Dr. Hersh and his colleagues included 1,809 adult patients treated at three different ICUs in two hospitals between January 2010 and December 2015. Treatment was delivered with a computerized ICU insulin infusion protocol that allows clinicians to choose between two blood glucose targets: 80-110 mg/dL or 90-140 mg/dL. The lower target was chosen for 951 patients, and the moderate target for 858 patients.
The most common primary admission diagnoses in the cohort included chest pain or acute coronary syndrome in 43.3%, cardiothoracic surgery in 31.9%, heart failure (including cardiogenic shock) in 6.8%, and vascular surgery in 6.0%.
While patients in the low blood glucose target group had a higher rate of moderate hypoglycemia, both groups had a low rate of severe hypoglycemia, at 1.16% in the low target group and 0.35% in the moderate target group (P = .051).
Unadjusted 30-day mortality was significantly lower in the 80-110–mg/dL group compared with the 90-140–mg/dL group (4.3% vs. 9.2%, respectively; P less than .001), according to the investigators.
Furthermore, logistic regression analysis showed that patients treated with a target of 80-110 mg/dL had a lower risk of 30-day mortality compared with patients with a target of 90-140 mg/dL (odds ratio 0.65; 95% confidence interval, 0.43-0.98; P = .04).
These results advance the debate over appropriate blood glucose targets in critically ill patients, as they suggest that the effects of targeting blood glucose and the effects of severe hypoglycemia “can be separated,” the investigators wrote.
Current guidelines on intensive insulin therapy are based in part on findings of the NICE-SUGAR trial, which found that among adults treated in the ICU, intensive glucose control increased mortality. However, a post hoc analysis suggested the mortality increase in NICE-SUGAR was “largely driven by a significant incidence of moderate hypoglycemia, and to a greater degree severe hypoglycemia,” Dr. Hersh and his coauthors noted in their report.
“Given improvements in insulin delivery and glucose monitoring, a reassessment of potential benefits of [intensive insulin therapy] should once again be evaluated in a prospective randomized trial,” they wrote.
Dr. Hersh and his coauthors declared no financial or nonfinancial disclosures related to the study.
SOURCE: Hersh AM et al. CHEST 2018. doi: 10.1016/j.chest.2018.04.025.
compared with patients with a target of 90-140 mg/dL, according to results of a retrospective cohort analysis.
With the computerized intravenous insulin protocol used in the study, the strict target could be achieved with a low rate of hypoglycemia, the authors wrote. The analysis was published in the journal CHEST®.
However, it does raise the possibility that earlier investigations finding an association between intensive insulin therapy and excess mortality “may have been accurate only in the setting of technologies which led to high rates of severe hypoglycemia,” they wrote.
The retrospective cohort analysis by Dr. Hersh and his colleagues included 1,809 adult patients treated at three different ICUs in two hospitals between January 2010 and December 2015. Treatment was delivered with a computerized ICU insulin infusion protocol that allows clinicians to choose between two blood glucose targets: 80-110 mg/dL or 90-140 mg/dL. The lower target was chosen for 951 patients, and the moderate target for 858 patients.
The most common primary admission diagnoses in the cohort included chest pain or acute coronary syndrome in 43.3%, cardiothoracic surgery in 31.9%, heart failure (including cardiogenic shock) in 6.8%, and vascular surgery in 6.0%.
While patients in the low blood glucose target group had a higher rate of moderate hypoglycemia, both groups had a low rate of severe hypoglycemia, at 1.16% in the low target group and 0.35% in the moderate target group (P = .051).
Unadjusted 30-day mortality was significantly lower in the 80-110–mg/dL group compared with the 90-140–mg/dL group (4.3% vs. 9.2%, respectively; P less than .001), according to the investigators.
Furthermore, logistic regression analysis showed that patients treated with a target of 80-110 mg/dL had a lower risk of 30-day mortality compared with patients with a target of 90-140 mg/dL (odds ratio 0.65; 95% confidence interval, 0.43-0.98; P = .04).
These results advance the debate over appropriate blood glucose targets in critically ill patients, as they suggest that the effects of targeting blood glucose and the effects of severe hypoglycemia “can be separated,” the investigators wrote.
Current guidelines on intensive insulin therapy are based in part on findings of the NICE-SUGAR trial, which found that among adults treated in the ICU, intensive glucose control increased mortality. However, a post hoc analysis suggested the mortality increase in NICE-SUGAR was “largely driven by a significant incidence of moderate hypoglycemia, and to a greater degree severe hypoglycemia,” Dr. Hersh and his coauthors noted in their report.
“Given improvements in insulin delivery and glucose monitoring, a reassessment of potential benefits of [intensive insulin therapy] should once again be evaluated in a prospective randomized trial,” they wrote.
Dr. Hersh and his coauthors declared no financial or nonfinancial disclosures related to the study.
SOURCE: Hersh AM et al. CHEST 2018. doi: 10.1016/j.chest.2018.04.025.
FROM THE JOURNAL CHEST®
Key clinical point: Among critically ill cardiac and cardiothoracic patients, a lower glucose target was associated with improved 30-day mortality.
Major finding: Patients treated with a target of 80-110 mg/dL had a lower risk of 30-day mortality compared with patients with a target of 90-140 mg/dL (odds ratio 0.65; 95% confidence interval, 0.43-0.98; P = .04).
Study details: A retrospective cohort analysis of 1,809 adult patients treated at three ICUs from two hospitals between January 2010 and December 2015.
Disclosures: The authors declared no disclosures.
Source: Hersh AM et al. CHEST 2018. doi: 10.1016/j.chest.2018.04.025.
Is medical aid in dying suicide?
WASHINGTON – Medical aid in dying is not the same as suicide; it is a way to give people with terminal illness and facing imminent death a way to die better and avoid the terrible, drawn-out deaths from chronic disease that often now occur, Margaret P. Battin, PhD, said at the annual conference of the American Association of Suicidology.
and is allowed now by law in Colorado, Hawaii, Montana, Oregon, Vermont, Washington, the District of Columbia, and by court decision in California. It’s also a legal option in Belgium, Canada, Luxembourg, the Netherlands, Switzerland, and parts of Germany, she said. Dr. Battin attributed the spread of legalized MAiD to the frequent terrible and protracted deaths people in industrialized countries face from chronic diseases such as cancer, heart disease, organ failure, dementia, stroke, and other neurologic disorders, and the comforting option of choice that MAiD offers these terminally ill patients. All the laws that have legalized MAiD draw distinctions between it and suicide, she noted.
“Even it the patient doesn’t act on this, someone facing death can find comfort knowing that if things get too bad, there is a way to avoid it, that they can have some control over their death. People want to remain in control, and this gives people a sense of control” that is not pathologic; it’s reassuring. “It can also make bereavement easier for others,” she said. Medical aid in dying “ helps people with terminal illness reduce their confusion, despair, and sense of impotence. When we can’t prevent death, this can make it better.” Dr. Battin also cited the restrictions these laws make to rule out people with mental illness or psychiatric problems that influence their choice of MAiD. That plus cultural and societal attitudes toward self-directed death mean that very few people actually wind up taking MAiD to completion.
But Thomas Joiner, PhD, dissented that the MAiD process successfully winnows out people who are acting on a desire for suicide in the traditional sense.
Another major problem with MAiD is that it focuses too much on self-determination and autonomy and downplays the importance of the social reverberations that this form of death has on others, he explained. “The social dimension is an afterthought [of MAiD], and that’s a problem.”
The American Association of Suicidality statement “has evolved, and Professor Battin had a lot to do with that, and I respect” the writing process. It shows better balance between autonomy and social connections, but I believe that [MAiD] is often an expression of [traditional] suicide,” Dr. Joiner said. MAiD has become more acceptable, “but that doesn’t make it right. It is trying to dodge the stigma of suicide.”
Dr. Battin and Dr. Joiner had no disclosures.
WASHINGTON – Medical aid in dying is not the same as suicide; it is a way to give people with terminal illness and facing imminent death a way to die better and avoid the terrible, drawn-out deaths from chronic disease that often now occur, Margaret P. Battin, PhD, said at the annual conference of the American Association of Suicidology.
and is allowed now by law in Colorado, Hawaii, Montana, Oregon, Vermont, Washington, the District of Columbia, and by court decision in California. It’s also a legal option in Belgium, Canada, Luxembourg, the Netherlands, Switzerland, and parts of Germany, she said. Dr. Battin attributed the spread of legalized MAiD to the frequent terrible and protracted deaths people in industrialized countries face from chronic diseases such as cancer, heart disease, organ failure, dementia, stroke, and other neurologic disorders, and the comforting option of choice that MAiD offers these terminally ill patients. All the laws that have legalized MAiD draw distinctions between it and suicide, she noted.
“Even it the patient doesn’t act on this, someone facing death can find comfort knowing that if things get too bad, there is a way to avoid it, that they can have some control over their death. People want to remain in control, and this gives people a sense of control” that is not pathologic; it’s reassuring. “It can also make bereavement easier for others,” she said. Medical aid in dying “ helps people with terminal illness reduce their confusion, despair, and sense of impotence. When we can’t prevent death, this can make it better.” Dr. Battin also cited the restrictions these laws make to rule out people with mental illness or psychiatric problems that influence their choice of MAiD. That plus cultural and societal attitudes toward self-directed death mean that very few people actually wind up taking MAiD to completion.
But Thomas Joiner, PhD, dissented that the MAiD process successfully winnows out people who are acting on a desire for suicide in the traditional sense.
Another major problem with MAiD is that it focuses too much on self-determination and autonomy and downplays the importance of the social reverberations that this form of death has on others, he explained. “The social dimension is an afterthought [of MAiD], and that’s a problem.”
The American Association of Suicidality statement “has evolved, and Professor Battin had a lot to do with that, and I respect” the writing process. It shows better balance between autonomy and social connections, but I believe that [MAiD] is often an expression of [traditional] suicide,” Dr. Joiner said. MAiD has become more acceptable, “but that doesn’t make it right. It is trying to dodge the stigma of suicide.”
Dr. Battin and Dr. Joiner had no disclosures.
WASHINGTON – Medical aid in dying is not the same as suicide; it is a way to give people with terminal illness and facing imminent death a way to die better and avoid the terrible, drawn-out deaths from chronic disease that often now occur, Margaret P. Battin, PhD, said at the annual conference of the American Association of Suicidology.
and is allowed now by law in Colorado, Hawaii, Montana, Oregon, Vermont, Washington, the District of Columbia, and by court decision in California. It’s also a legal option in Belgium, Canada, Luxembourg, the Netherlands, Switzerland, and parts of Germany, she said. Dr. Battin attributed the spread of legalized MAiD to the frequent terrible and protracted deaths people in industrialized countries face from chronic diseases such as cancer, heart disease, organ failure, dementia, stroke, and other neurologic disorders, and the comforting option of choice that MAiD offers these terminally ill patients. All the laws that have legalized MAiD draw distinctions between it and suicide, she noted.
“Even it the patient doesn’t act on this, someone facing death can find comfort knowing that if things get too bad, there is a way to avoid it, that they can have some control over their death. People want to remain in control, and this gives people a sense of control” that is not pathologic; it’s reassuring. “It can also make bereavement easier for others,” she said. Medical aid in dying “ helps people with terminal illness reduce their confusion, despair, and sense of impotence. When we can’t prevent death, this can make it better.” Dr. Battin also cited the restrictions these laws make to rule out people with mental illness or psychiatric problems that influence their choice of MAiD. That plus cultural and societal attitudes toward self-directed death mean that very few people actually wind up taking MAiD to completion.
But Thomas Joiner, PhD, dissented that the MAiD process successfully winnows out people who are acting on a desire for suicide in the traditional sense.
Another major problem with MAiD is that it focuses too much on self-determination and autonomy and downplays the importance of the social reverberations that this form of death has on others, he explained. “The social dimension is an afterthought [of MAiD], and that’s a problem.”
The American Association of Suicidality statement “has evolved, and Professor Battin had a lot to do with that, and I respect” the writing process. It shows better balance between autonomy and social connections, but I believe that [MAiD] is often an expression of [traditional] suicide,” Dr. Joiner said. MAiD has become more acceptable, “but that doesn’t make it right. It is trying to dodge the stigma of suicide.”
Dr. Battin and Dr. Joiner had no disclosures.
REPORTING FROM THE AAS ANNUAL CONFERENCE
MDedge Daily News: Can a nasal spray reverse suicidality?
Smoking boosts heart failure risk in black patients. Respiratory infections increase risk of heart attack and stroke. And pain relievers and inflammatory bowel disease? It’s complicated.
Listen to the MDedge Daily News podcast for all the details on today’s top news.
Smoking boosts heart failure risk in black patients. Respiratory infections increase risk of heart attack and stroke. And pain relievers and inflammatory bowel disease? It’s complicated.
Listen to the MDedge Daily News podcast for all the details on today’s top news.
Smoking boosts heart failure risk in black patients. Respiratory infections increase risk of heart attack and stroke. And pain relievers and inflammatory bowel disease? It’s complicated.
Listen to the MDedge Daily News podcast for all the details on today’s top news.
Smoking increases heart failure risk in blacks
Cigarette smoking is an important risk factor for heart failure in blacks, according to results of an investigation of patients in the Jackson Heart Study.
Current smoking among blacks was associated with higher mean left ventricular (LV) mass and lower mean LV systolic function, even after adjustment for confounding factors, authors of the analysis reported in the journal Circulation.
While blacks are known to have a higher incidence of heart failure than do whites, Hispanics, and Asians, this is believed to be the first prospective study of a large black cohort demonstrating a dose-response relationship between smoking and incident heart failure.
“Smoking cessation may be a potential strategy to attenuate the higher rate of heart failure in blacks,” wrote Dr. Kamimura and coauthors.
The published analysis included data on 4,129 participants in the Jackson Heart Study, a large, prospective, community-based observational study investigating cardiovascular risk factors in blacks.
That group, which was 63% female, included 503 current smokers, 742 former smokers, and 2,884 individuals who had never smoked.
At baseline, no patients had a history of heart failure or coronary heart disease, and over a median follow-up of 8.0 years, there were 147 hospitalizations for heart failure in the cohort, the investigators reported.
Current smoking, compared with never smoking, was significantly associated with incident heart failure hospitalization after adjusting for risk factors and coronary heart disease (hazard ratio, 2.82; 95% confidence interval, 1.71-4.64).
Likewise, smoking intensity of at least 20 cigarettes a day (HR, 3.48; 95% CI, 1.65-7.32) and smoking burden of at least 15 pack-years (HR, 2.06; 95% CI, 1.29-3.33) both were significantly associated with incident heart failure hospitalization .
Compared with never smoking, current smoking was significantly associated with higher mean LV mass index and lower mean LV circumferential strain, even after adjusting for confounding variables (P less than 0.05 for both comparisons).
Smoking status also was associated with higher mean levels of brain natriuretic peptide, as were smoking intensity and burden (P less than 0.05 for all three comparisons), data show.
While cigarette smoking is a well-known risk factor for cardiovascular disease, Dr. Kamimura and coauthors said the influences on cardiac structure and function may not be fully appreciated because of the strong association with coronary heart disease, a major cause of heart failure.
“These relationships were significant after adjustment for coronary heart disease, suggesting mechanisms beyond atherosclerosis probably contribute to myocardial dysfunction and increased risk of heart failure in smokers,” they wrote in a discussion of the results.
Authors reported that they had no conflicts of interest related to the study. The Jackson Heart Study is supported by Jackson (Miss.) State University, Tougaloo College, and the University of Mississippi Medical Center, all in Jackson, contracts from the National Heart, Lung, and Blood Institute and the National Institute for Minority Health and Health Disparities. This study was supported by the NHLBI. One author has also received support from the National Institute of Diabetes and Digestive and Kidney Diseases and The National Institute of General Medical Sciences.
SOURCE: Kamimura D et al. Circulation. 2018. doi: 10.1161/CIRCULATIONAHA.117.031912.
Cigarette smoking is an important risk factor for heart failure in blacks, according to results of an investigation of patients in the Jackson Heart Study.
Current smoking among blacks was associated with higher mean left ventricular (LV) mass and lower mean LV systolic function, even after adjustment for confounding factors, authors of the analysis reported in the journal Circulation.
While blacks are known to have a higher incidence of heart failure than do whites, Hispanics, and Asians, this is believed to be the first prospective study of a large black cohort demonstrating a dose-response relationship between smoking and incident heart failure.
“Smoking cessation may be a potential strategy to attenuate the higher rate of heart failure in blacks,” wrote Dr. Kamimura and coauthors.
The published analysis included data on 4,129 participants in the Jackson Heart Study, a large, prospective, community-based observational study investigating cardiovascular risk factors in blacks.
That group, which was 63% female, included 503 current smokers, 742 former smokers, and 2,884 individuals who had never smoked.
At baseline, no patients had a history of heart failure or coronary heart disease, and over a median follow-up of 8.0 years, there were 147 hospitalizations for heart failure in the cohort, the investigators reported.
Current smoking, compared with never smoking, was significantly associated with incident heart failure hospitalization after adjusting for risk factors and coronary heart disease (hazard ratio, 2.82; 95% confidence interval, 1.71-4.64).
Likewise, smoking intensity of at least 20 cigarettes a day (HR, 3.48; 95% CI, 1.65-7.32) and smoking burden of at least 15 pack-years (HR, 2.06; 95% CI, 1.29-3.33) both were significantly associated with incident heart failure hospitalization .
Compared with never smoking, current smoking was significantly associated with higher mean LV mass index and lower mean LV circumferential strain, even after adjusting for confounding variables (P less than 0.05 for both comparisons).
Smoking status also was associated with higher mean levels of brain natriuretic peptide, as were smoking intensity and burden (P less than 0.05 for all three comparisons), data show.
While cigarette smoking is a well-known risk factor for cardiovascular disease, Dr. Kamimura and coauthors said the influences on cardiac structure and function may not be fully appreciated because of the strong association with coronary heart disease, a major cause of heart failure.
“These relationships were significant after adjustment for coronary heart disease, suggesting mechanisms beyond atherosclerosis probably contribute to myocardial dysfunction and increased risk of heart failure in smokers,” they wrote in a discussion of the results.
Authors reported that they had no conflicts of interest related to the study. The Jackson Heart Study is supported by Jackson (Miss.) State University, Tougaloo College, and the University of Mississippi Medical Center, all in Jackson, contracts from the National Heart, Lung, and Blood Institute and the National Institute for Minority Health and Health Disparities. This study was supported by the NHLBI. One author has also received support from the National Institute of Diabetes and Digestive and Kidney Diseases and The National Institute of General Medical Sciences.
SOURCE: Kamimura D et al. Circulation. 2018. doi: 10.1161/CIRCULATIONAHA.117.031912.
Cigarette smoking is an important risk factor for heart failure in blacks, according to results of an investigation of patients in the Jackson Heart Study.
Current smoking among blacks was associated with higher mean left ventricular (LV) mass and lower mean LV systolic function, even after adjustment for confounding factors, authors of the analysis reported in the journal Circulation.
While blacks are known to have a higher incidence of heart failure than do whites, Hispanics, and Asians, this is believed to be the first prospective study of a large black cohort demonstrating a dose-response relationship between smoking and incident heart failure.
“Smoking cessation may be a potential strategy to attenuate the higher rate of heart failure in blacks,” wrote Dr. Kamimura and coauthors.
The published analysis included data on 4,129 participants in the Jackson Heart Study, a large, prospective, community-based observational study investigating cardiovascular risk factors in blacks.
That group, which was 63% female, included 503 current smokers, 742 former smokers, and 2,884 individuals who had never smoked.
At baseline, no patients had a history of heart failure or coronary heart disease, and over a median follow-up of 8.0 years, there were 147 hospitalizations for heart failure in the cohort, the investigators reported.
Current smoking, compared with never smoking, was significantly associated with incident heart failure hospitalization after adjusting for risk factors and coronary heart disease (hazard ratio, 2.82; 95% confidence interval, 1.71-4.64).
Likewise, smoking intensity of at least 20 cigarettes a day (HR, 3.48; 95% CI, 1.65-7.32) and smoking burden of at least 15 pack-years (HR, 2.06; 95% CI, 1.29-3.33) both were significantly associated with incident heart failure hospitalization .
Compared with never smoking, current smoking was significantly associated with higher mean LV mass index and lower mean LV circumferential strain, even after adjusting for confounding variables (P less than 0.05 for both comparisons).
Smoking status also was associated with higher mean levels of brain natriuretic peptide, as were smoking intensity and burden (P less than 0.05 for all three comparisons), data show.
While cigarette smoking is a well-known risk factor for cardiovascular disease, Dr. Kamimura and coauthors said the influences on cardiac structure and function may not be fully appreciated because of the strong association with coronary heart disease, a major cause of heart failure.
“These relationships were significant after adjustment for coronary heart disease, suggesting mechanisms beyond atherosclerosis probably contribute to myocardial dysfunction and increased risk of heart failure in smokers,” they wrote in a discussion of the results.
Authors reported that they had no conflicts of interest related to the study. The Jackson Heart Study is supported by Jackson (Miss.) State University, Tougaloo College, and the University of Mississippi Medical Center, all in Jackson, contracts from the National Heart, Lung, and Blood Institute and the National Institute for Minority Health and Health Disparities. This study was supported by the NHLBI. One author has also received support from the National Institute of Diabetes and Digestive and Kidney Diseases and The National Institute of General Medical Sciences.
SOURCE: Kamimura D et al. Circulation. 2018. doi: 10.1161/CIRCULATIONAHA.117.031912.
FROM CIRCULATION
Key clinical point: Major finding: Current smoking, cigarettes per day, and smoking burden in pack-years were all independently associated with incident heart failure hospitalization (hazard ratio 2.82, 3.48, and 2.06, respectively) even after adjusting for risk factors and coronary heart disease.
Study details: Analysis of 4,129 participants in the Jackson Heart Study, a large, prospective, community-based observational study investigating cardiovascular risk factors in blacks.
Disclosures: Authors reported that they had no conflicts of interest related to the study. The Jackson Heart Study is supported by Jackson (Miss.) State University; Tougaloo College, and the University of Mississippi Medical Center, all in Jackson, contracts from the National Heart, Lung, and Blood Institute and the National Institute for Minority Health and Health Disparities. This study was supported by the NHLBI. One author has received support from the National Institute of Diabetes and Digestive and Kidney Diseases and the National Institute of General Medical Sciences.
Source: Kamimura D et al. Circulation. 2018. doi: 10.1161/CIRCULATIONAHA.117.031912.
Transcatheter valves underperform for native aortic regurgitation
WASHINGTON – Transcatheter heart valves (THV) developed for the treatment of symptomatic aortic stenosis have been used off label for the treatment of native aortic valve regurgitation (NAVR), but registry data suggest that outcomes have been disappointing, according to a presentation at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
“Although significant improvement was seen with newer-generation THV devices, TAVR [transcatheter aortic valve replacement] for NAVR is a challenging approach associated with limited procedural efficacy,” reported Danny Dvir, MD, a prosthetic heart valve specialist and assistant professor of cardiology at the University of Washington, Seattle.
Results improved substantially with second-generation devices. For example, Dr. Dvir reported that the rate of device success climbed from 47% to 82% while correct positioning climbed from 67% to 91%. The proportion of patients without moderate or severe aortic regurgitation after placement of the THV climbed from 69% to 96%.
These improvements were reflected in clinical outcomes at 30 days. When second-generation devices were compared with first-generation devices, there was a reduction in all cause mortality (8% vs. 17%) and cardiac mortality (7% vs. 12%). There were also reductions from first- to second-generation devices in noncardiac mortality (1% vs. 5%), valve-related dysfunction (10% vs. 29%), and proportion of patients in New York Heart Association class III or IV (13% vs. 18%).
The improvement in outcomes from first- to second-generation devices is encouraging, but Dr. Dvir indicated that the main message is that TAVR for NAVR is producing success rates that “are suboptimal” and “not comparable to those being achieved when the indication is aortic stenosis.” The reasons cannot be derived from these data, but he suggested that optimal sizing of the device for NAVR might be different than it is for aortic stenosis.
“I wonder if we should have better devices designed specifically for aortic regurgitation,” Dr. Dvir said.
Despite the improved results with second-generation THV, receipt of a first-generation device was not a significant predictor of mortality at 1 year. Rather, in an analysis of predictors, mortality was significantly increased in those with moderate or worse aortic regurgitation, Society of Thoracic Surgeons risk score of 8% or greater, and acute kidney injury of grade 2 or higher. There was also a trend for increased mortality in those with pulmonary hypertension.
Most of the devices (76%) were placed with a transfemoral approach. No difference in mortality was observed when a transfemoral approach was compared with a nontransfemoral approach.
According to the registry data, a 10%-20% oversizing of the THV was associated with a reduced risk of malpositioning, relative to devices with less than 10% oversizing or greater than 20% oversizing, reinforcing Dr. Dvir’s hypothesis that sizing is a variable affecting outcome in NAVR.
Although Dr. Dvir contended that these data raise issues about the suitability of current THV designs for use in the treatment of NAVR, not all experts were convinced by these data. Jeffrey Popma, MD, director of the interventional cardiology clinical service at Beth Israel Deaconess Hospital, Boston, questioned whether more experience is placing these devices for NAVR might lead to greater success.
“There are two variables to consider,” Dr. Popma said. “One is the valve and one is how much we’ve evolved our procedure over the past couple of years.” He indicated that these data do not preclude advances that would improve results in NAVR even without developing new valves specific for this indication.
Dr. Dvir reported financial relationships with Edwards Lifesciences, Medtronic, Abbott, and Jena.
SOURCE: Dvir D. CRT 2018.
WASHINGTON – Transcatheter heart valves (THV) developed for the treatment of symptomatic aortic stenosis have been used off label for the treatment of native aortic valve regurgitation (NAVR), but registry data suggest that outcomes have been disappointing, according to a presentation at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
“Although significant improvement was seen with newer-generation THV devices, TAVR [transcatheter aortic valve replacement] for NAVR is a challenging approach associated with limited procedural efficacy,” reported Danny Dvir, MD, a prosthetic heart valve specialist and assistant professor of cardiology at the University of Washington, Seattle.
Results improved substantially with second-generation devices. For example, Dr. Dvir reported that the rate of device success climbed from 47% to 82% while correct positioning climbed from 67% to 91%. The proportion of patients without moderate or severe aortic regurgitation after placement of the THV climbed from 69% to 96%.
These improvements were reflected in clinical outcomes at 30 days. When second-generation devices were compared with first-generation devices, there was a reduction in all cause mortality (8% vs. 17%) and cardiac mortality (7% vs. 12%). There were also reductions from first- to second-generation devices in noncardiac mortality (1% vs. 5%), valve-related dysfunction (10% vs. 29%), and proportion of patients in New York Heart Association class III or IV (13% vs. 18%).
The improvement in outcomes from first- to second-generation devices is encouraging, but Dr. Dvir indicated that the main message is that TAVR for NAVR is producing success rates that “are suboptimal” and “not comparable to those being achieved when the indication is aortic stenosis.” The reasons cannot be derived from these data, but he suggested that optimal sizing of the device for NAVR might be different than it is for aortic stenosis.
“I wonder if we should have better devices designed specifically for aortic regurgitation,” Dr. Dvir said.
Despite the improved results with second-generation THV, receipt of a first-generation device was not a significant predictor of mortality at 1 year. Rather, in an analysis of predictors, mortality was significantly increased in those with moderate or worse aortic regurgitation, Society of Thoracic Surgeons risk score of 8% or greater, and acute kidney injury of grade 2 or higher. There was also a trend for increased mortality in those with pulmonary hypertension.
Most of the devices (76%) were placed with a transfemoral approach. No difference in mortality was observed when a transfemoral approach was compared with a nontransfemoral approach.
According to the registry data, a 10%-20% oversizing of the THV was associated with a reduced risk of malpositioning, relative to devices with less than 10% oversizing or greater than 20% oversizing, reinforcing Dr. Dvir’s hypothesis that sizing is a variable affecting outcome in NAVR.
Although Dr. Dvir contended that these data raise issues about the suitability of current THV designs for use in the treatment of NAVR, not all experts were convinced by these data. Jeffrey Popma, MD, director of the interventional cardiology clinical service at Beth Israel Deaconess Hospital, Boston, questioned whether more experience is placing these devices for NAVR might lead to greater success.
“There are two variables to consider,” Dr. Popma said. “One is the valve and one is how much we’ve evolved our procedure over the past couple of years.” He indicated that these data do not preclude advances that would improve results in NAVR even without developing new valves specific for this indication.
Dr. Dvir reported financial relationships with Edwards Lifesciences, Medtronic, Abbott, and Jena.
SOURCE: Dvir D. CRT 2018.
WASHINGTON – Transcatheter heart valves (THV) developed for the treatment of symptomatic aortic stenosis have been used off label for the treatment of native aortic valve regurgitation (NAVR), but registry data suggest that outcomes have been disappointing, according to a presentation at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
“Although significant improvement was seen with newer-generation THV devices, TAVR [transcatheter aortic valve replacement] for NAVR is a challenging approach associated with limited procedural efficacy,” reported Danny Dvir, MD, a prosthetic heart valve specialist and assistant professor of cardiology at the University of Washington, Seattle.
Results improved substantially with second-generation devices. For example, Dr. Dvir reported that the rate of device success climbed from 47% to 82% while correct positioning climbed from 67% to 91%. The proportion of patients without moderate or severe aortic regurgitation after placement of the THV climbed from 69% to 96%.
These improvements were reflected in clinical outcomes at 30 days. When second-generation devices were compared with first-generation devices, there was a reduction in all cause mortality (8% vs. 17%) and cardiac mortality (7% vs. 12%). There were also reductions from first- to second-generation devices in noncardiac mortality (1% vs. 5%), valve-related dysfunction (10% vs. 29%), and proportion of patients in New York Heart Association class III or IV (13% vs. 18%).
The improvement in outcomes from first- to second-generation devices is encouraging, but Dr. Dvir indicated that the main message is that TAVR for NAVR is producing success rates that “are suboptimal” and “not comparable to those being achieved when the indication is aortic stenosis.” The reasons cannot be derived from these data, but he suggested that optimal sizing of the device for NAVR might be different than it is for aortic stenosis.
“I wonder if we should have better devices designed specifically for aortic regurgitation,” Dr. Dvir said.
Despite the improved results with second-generation THV, receipt of a first-generation device was not a significant predictor of mortality at 1 year. Rather, in an analysis of predictors, mortality was significantly increased in those with moderate or worse aortic regurgitation, Society of Thoracic Surgeons risk score of 8% or greater, and acute kidney injury of grade 2 or higher. There was also a trend for increased mortality in those with pulmonary hypertension.
Most of the devices (76%) were placed with a transfemoral approach. No difference in mortality was observed when a transfemoral approach was compared with a nontransfemoral approach.
According to the registry data, a 10%-20% oversizing of the THV was associated with a reduced risk of malpositioning, relative to devices with less than 10% oversizing or greater than 20% oversizing, reinforcing Dr. Dvir’s hypothesis that sizing is a variable affecting outcome in NAVR.
Although Dr. Dvir contended that these data raise issues about the suitability of current THV designs for use in the treatment of NAVR, not all experts were convinced by these data. Jeffrey Popma, MD, director of the interventional cardiology clinical service at Beth Israel Deaconess Hospital, Boston, questioned whether more experience is placing these devices for NAVR might lead to greater success.
“There are two variables to consider,” Dr. Popma said. “One is the valve and one is how much we’ve evolved our procedure over the past couple of years.” He indicated that these data do not preclude advances that would improve results in NAVR even without developing new valves specific for this indication.
Dr. Dvir reported financial relationships with Edwards Lifesciences, Medtronic, Abbott, and Jena.
SOURCE: Dvir D. CRT 2018.
AT THE 2018 CRT MEETING
Key clinical point:
Major finding: With newer-generation THV, rates of incorrect positioning (9%), persistent regurgitation (4%), and 30-day mortality (8%) remain unacceptably high.
Data source: A registry data analysis.
Disclosures: Dr. Dvir reported financial relationships with Edwards Lifesciences, Medtronic, Abbott, and Jena.
Source: Dvir D. CRT 2018.
Permanent His-bundle pacing superior to RV pacing
ORLANDO – Pacing at the bundle of His was associated with significantly reduced morbidity and mortality, compared with right ventricular pacing, over time in a large observational registry of patients needing a permanent pacemaker for bradycardia, Mohamed Abdelrahman, MD, reported at the annual meeting of the American College of Cardiology.
The superiority of His-bundle pacing (HBP) was concentrated in patients who required ventricular pacing more than 20% of the time. This finding is consistent with previous reports that even a modest utilization of ventricular pacing is sufficient to boost the risk of left ventricular dysfunction secondary to electrical and mechanical dyssynchrony, added Dr. Abdelrahman of the Geisinger Heart Institute in Danville, Pa.
The primary study endpoint was a composite of all-cause mortality, heart-failure hospitalization, and biventricular pacing upgrade. During a mean 2 years of follow-up, this endpoint was reached in 25% of the HBP group, compared with 32% of the RVP group, for a significant 29% relative risk reduction. In patients with a ventricular pacing burden greater than 20%, the primary endpoint occurred in 25% of the HBP group and 36% of patients with RVP, for a 35% relative risk reduction. However, in patients who required ventricular pacing less than 20% of the time, there was no significant difference in the primary outcome between the two groups.
Heart failure hospitalization occurred in 12.4% of the HBP group and 17.6% of the RVP patients, for a 37% relative risk reduction. In patients with ventricular pacing more than 20% of the time, the rates were 12.4% and 20.1%, for a 46% relative risk reduction in favor of HBP.
Among patients with a ventricular pacing burden of more than 20%, all-cause mortality occurred in 18% of the HBP group, compared with 23.7% of RVP-treated patients.
One patient in the HBP group required an upgrade to biventricular pacing, as did six patients in the RVP group. Lead revision was necessary in 14 patients in the HBP group, versus 2 in the RVP group. Pericardial effusion within the first month of pacemaker implantation occurred in three patients in the RVP group and did not occur in the HBP group.
Discussant Kristen K. Patton, MD, called the Geisinger work “a really wonderful study,” adding, “It’s incredibly difficult to overstate how excited we are in electrophysiology about His-bundle pacing and what a wonderfully elegant solution this is to the problem of pacing-induced dyssynchrony.
“Is there anything that gives you pause, any patients in whom the increased risk of revisions makes you think, ‘I shouldn’t do this in everyone?’ Because I can tell you, it’s hard not to want to do this in everyone,” said Dr. Patton, professor of medicine at the University of Washington, Seattle.
Dr. Abdelrahman replied that Geisinger electrophysiologists now utilize HBP in all patients who require a permanent pacemaker for bradycardia.
Session chair Martin B. Leon, MD, of Columbia University, New York, had a question: “This is such an important area. Why didn’t you do a randomized trial from the start?”
Dr. Abdelrahman’s senior coinvestigator, Pugazhendhi Vijayaraman, MD, explained: “His-bundle pacing has been around for the last 20 years. It’s had its ups and downs. In the last few years there’s been a groundswell of implanters doing His-bundle pacing. The number of implanters here and around the world is rapidly expanding. So we are ready for a randomized trial, and we’ve applied for funding from the National Institutes of Health. Industry support for this has not been forthcoming because His-bundle pacing does not seem to add to the value of a company’s portfolio, but more to better patient outcomes.”
He emphasized that, of the 14 patients in the HBP group who underwent lead revision, only 2 had absolute lead failure and loss of capture, underscoring the safety of this pacing strategy.
Dr. Abdelrahman reported having no financial conflicts of interest regarding the study.
SOURCE: Abdelrahman M. ACC 18.
ORLANDO – Pacing at the bundle of His was associated with significantly reduced morbidity and mortality, compared with right ventricular pacing, over time in a large observational registry of patients needing a permanent pacemaker for bradycardia, Mohamed Abdelrahman, MD, reported at the annual meeting of the American College of Cardiology.
The superiority of His-bundle pacing (HBP) was concentrated in patients who required ventricular pacing more than 20% of the time. This finding is consistent with previous reports that even a modest utilization of ventricular pacing is sufficient to boost the risk of left ventricular dysfunction secondary to electrical and mechanical dyssynchrony, added Dr. Abdelrahman of the Geisinger Heart Institute in Danville, Pa.
The primary study endpoint was a composite of all-cause mortality, heart-failure hospitalization, and biventricular pacing upgrade. During a mean 2 years of follow-up, this endpoint was reached in 25% of the HBP group, compared with 32% of the RVP group, for a significant 29% relative risk reduction. In patients with a ventricular pacing burden greater than 20%, the primary endpoint occurred in 25% of the HBP group and 36% of patients with RVP, for a 35% relative risk reduction. However, in patients who required ventricular pacing less than 20% of the time, there was no significant difference in the primary outcome between the two groups.
Heart failure hospitalization occurred in 12.4% of the HBP group and 17.6% of the RVP patients, for a 37% relative risk reduction. In patients with ventricular pacing more than 20% of the time, the rates were 12.4% and 20.1%, for a 46% relative risk reduction in favor of HBP.
Among patients with a ventricular pacing burden of more than 20%, all-cause mortality occurred in 18% of the HBP group, compared with 23.7% of RVP-treated patients.
One patient in the HBP group required an upgrade to biventricular pacing, as did six patients in the RVP group. Lead revision was necessary in 14 patients in the HBP group, versus 2 in the RVP group. Pericardial effusion within the first month of pacemaker implantation occurred in three patients in the RVP group and did not occur in the HBP group.
Discussant Kristen K. Patton, MD, called the Geisinger work “a really wonderful study,” adding, “It’s incredibly difficult to overstate how excited we are in electrophysiology about His-bundle pacing and what a wonderfully elegant solution this is to the problem of pacing-induced dyssynchrony.
“Is there anything that gives you pause, any patients in whom the increased risk of revisions makes you think, ‘I shouldn’t do this in everyone?’ Because I can tell you, it’s hard not to want to do this in everyone,” said Dr. Patton, professor of medicine at the University of Washington, Seattle.
Dr. Abdelrahman replied that Geisinger electrophysiologists now utilize HBP in all patients who require a permanent pacemaker for bradycardia.
Session chair Martin B. Leon, MD, of Columbia University, New York, had a question: “This is such an important area. Why didn’t you do a randomized trial from the start?”
Dr. Abdelrahman’s senior coinvestigator, Pugazhendhi Vijayaraman, MD, explained: “His-bundle pacing has been around for the last 20 years. It’s had its ups and downs. In the last few years there’s been a groundswell of implanters doing His-bundle pacing. The number of implanters here and around the world is rapidly expanding. So we are ready for a randomized trial, and we’ve applied for funding from the National Institutes of Health. Industry support for this has not been forthcoming because His-bundle pacing does not seem to add to the value of a company’s portfolio, but more to better patient outcomes.”
He emphasized that, of the 14 patients in the HBP group who underwent lead revision, only 2 had absolute lead failure and loss of capture, underscoring the safety of this pacing strategy.
Dr. Abdelrahman reported having no financial conflicts of interest regarding the study.
SOURCE: Abdelrahman M. ACC 18.
ORLANDO – Pacing at the bundle of His was associated with significantly reduced morbidity and mortality, compared with right ventricular pacing, over time in a large observational registry of patients needing a permanent pacemaker for bradycardia, Mohamed Abdelrahman, MD, reported at the annual meeting of the American College of Cardiology.
The superiority of His-bundle pacing (HBP) was concentrated in patients who required ventricular pacing more than 20% of the time. This finding is consistent with previous reports that even a modest utilization of ventricular pacing is sufficient to boost the risk of left ventricular dysfunction secondary to electrical and mechanical dyssynchrony, added Dr. Abdelrahman of the Geisinger Heart Institute in Danville, Pa.
The primary study endpoint was a composite of all-cause mortality, heart-failure hospitalization, and biventricular pacing upgrade. During a mean 2 years of follow-up, this endpoint was reached in 25% of the HBP group, compared with 32% of the RVP group, for a significant 29% relative risk reduction. In patients with a ventricular pacing burden greater than 20%, the primary endpoint occurred in 25% of the HBP group and 36% of patients with RVP, for a 35% relative risk reduction. However, in patients who required ventricular pacing less than 20% of the time, there was no significant difference in the primary outcome between the two groups.
Heart failure hospitalization occurred in 12.4% of the HBP group and 17.6% of the RVP patients, for a 37% relative risk reduction. In patients with ventricular pacing more than 20% of the time, the rates were 12.4% and 20.1%, for a 46% relative risk reduction in favor of HBP.
Among patients with a ventricular pacing burden of more than 20%, all-cause mortality occurred in 18% of the HBP group, compared with 23.7% of RVP-treated patients.
One patient in the HBP group required an upgrade to biventricular pacing, as did six patients in the RVP group. Lead revision was necessary in 14 patients in the HBP group, versus 2 in the RVP group. Pericardial effusion within the first month of pacemaker implantation occurred in three patients in the RVP group and did not occur in the HBP group.
Discussant Kristen K. Patton, MD, called the Geisinger work “a really wonderful study,” adding, “It’s incredibly difficult to overstate how excited we are in electrophysiology about His-bundle pacing and what a wonderfully elegant solution this is to the problem of pacing-induced dyssynchrony.
“Is there anything that gives you pause, any patients in whom the increased risk of revisions makes you think, ‘I shouldn’t do this in everyone?’ Because I can tell you, it’s hard not to want to do this in everyone,” said Dr. Patton, professor of medicine at the University of Washington, Seattle.
Dr. Abdelrahman replied that Geisinger electrophysiologists now utilize HBP in all patients who require a permanent pacemaker for bradycardia.
Session chair Martin B. Leon, MD, of Columbia University, New York, had a question: “This is such an important area. Why didn’t you do a randomized trial from the start?”
Dr. Abdelrahman’s senior coinvestigator, Pugazhendhi Vijayaraman, MD, explained: “His-bundle pacing has been around for the last 20 years. It’s had its ups and downs. In the last few years there’s been a groundswell of implanters doing His-bundle pacing. The number of implanters here and around the world is rapidly expanding. So we are ready for a randomized trial, and we’ve applied for funding from the National Institutes of Health. Industry support for this has not been forthcoming because His-bundle pacing does not seem to add to the value of a company’s portfolio, but more to better patient outcomes.”
He emphasized that, of the 14 patients in the HBP group who underwent lead revision, only 2 had absolute lead failure and loss of capture, underscoring the safety of this pacing strategy.
Dr. Abdelrahman reported having no financial conflicts of interest regarding the study.
SOURCE: Abdelrahman M. ACC 18.
REPORTING FROM ACC 18
Key clinical point:
Major finding: The combined rate of all-cause mortality, heart-failure hospitalization, and biventricular pacing upgrade during a mean 2 years of follow-up was 25% in patients with His-bundle pacing, compared with 32% with right ventricular pacing.
Study details: This observational registry included 765 consecutive patients who required an initial permanent pacemaker implantation. All those treated at one medical center underwent an attempt at His-bundle pacing, while all those at a closely allied sister medical center received right ventricular pacing.
Disclosures: The study presenter reported having no financial conflicts of interest.
Source: Abdelrahman M. ACC 18.