Ratika Parkash1, George A Wells2, Jean Rouleau3, Mario Talajic3, Vidal Essebag4, Allan Skanes5, Stephen B Wilton6, Atul Verma7, Jeffrey S Healey8, Laurence Sterns9, Matthew Bennett10, Jean-Francois Roux11, Lena Rivard3, Peter Leong-Sit5, Mats Jensen-Urstad12, Umjeet Jolly13, Francois Philippon14, John L Sapp1, Anthony S L Tang5. 1. Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia, Canada (R.P., J.L.S.). 2. University of Ottawa Cardiovascular Research Methods Centre, Ontario, Canada (G.A.W.). 3. Montréal Heart Institute, Université de Montréal, Québec, Canada (J.R., M.T., L.R.). 4. McGill University Health Centre, Montreal, Québec, Canada (V.E.). 5. Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada (A.S., P.L.-S., A.S.L.T.). 6. Libin Cardiovascular Institute, University of Calgary, Alberta, Canada (S.B.W.). 7. Southlake Regional Health Centre, Ontario, Canada (A.V.). 8. Population Health Research Institute, Hamilton, Ontario, Canada (J.S.H.). 9. Royal Jubilee Hospital, Island Health Authority, Victoria, British Columbia, Canada (L.S.). 10. Centre for Cardiovascular Innovation, Division of Cardiology, University of British Columbia, Vancouver, Canada (M.B.). 11. Centre Hospitalier de Universite de Sherbrooke, Sherbrooke, Québec, Canada (J.-F.R.). 12. Karolinska Institute, Stockholm, Sweden (M.J.-U.). 13. St. Mary's General Hospital, Kitchener, Ontario, Canada (U.J.). 14. Institut universitaire de cardiologie et de pneumologie de Québec, Québec City, Canada (F.P.).
Abstract
BACKGROUND: Atrial fibrillation (AF) and heart failure (HF) frequently coexist and can be challenging to treat. Pharmacologically based rhythm control of AF has not proven to be superior to rate control. Ablation-based rhythm control was compared with rate control to evaluate if clinical outcomes in patients with HF and AF could be improved. METHODS: This was a multicenter, open-label trial with blinded outcome evaluation using a central adjudication committee. Patients with high-burden paroxysmal (>4 episodes in 6 months) or persistent (duration <3 years) AF, New York Heart Association class II to III HF, and elevated NT-proBNP (N-terminal pro brain natriuretic peptide) were randomly assigned to ablation-based rhythm control or rate control. The primary outcome was a composite of all-cause mortality and all HF events, with a minimum follow-up of 2 years. Secondary outcomes included left ventricular ejection fraction, 6-minute walk test, and NT-proBNP. Quality of life was measured using the Minnesota Living With Heart Failure Questionnaire and the AF Effect on Quality of Life. The primary analysis was time-to-event using Cox proportional hazards modeling. The trial was stopped early because of a determination of apparent futility by the Data Safety Monitoring Committee. RESULTS: From December 1, 2011, to January 20, 2018, 411 patients were randomly assigned to ablation-based rhythm control (n=214) or rate control (n=197). The primary outcome occurred in 50 (23.4%) patients in the ablation-based rhythm-control group and 64 (32.5%) patients in the rate-control group (hazard ratio, 0.71 [95% CI, 0.49-1.03]; P=0.066). Left ventricular ejection fraction increased in the ablation-based group (10.1±1.2% versus 3.8±1.2%, P=0.017), 6-minute walk distance improved (44.9±9.1 m versus 27.5±9.7 m, P=0.025), and NT-proBNP demonstrated a decrease (mean change -77.1% versus -39.2%, P<0.0001). Minnesota Living With Heart Failure Questionnaire demonstrated greater improvement in the ablation-based rhythm-control group (least-squares mean difference of -5.4 [95% CI, -10.5 to -0.3]; P=0.0036), as did the AF Effect on Quality of Life score (least-squares mean difference of 6.2 [95% CI, 1.7-10.7]; P=0.0005). Serious adverse events were observed in 50% of patients in both treatment groups. CONCLUSIONS: In patients with high-burden AF and HF, there was no statistical difference in all-cause mortality or HF events with ablation-based rhythm control versus rate control; however, there was a nonsignificant trend for improved outcomes with ablation-based rhythm control over rate control. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT01420393.
BACKGROUND: Atrial fibrillation (AF) and heart failure (HF) frequently coexist and can be challenging to treat. Pharmacologically based rhythm control of AF has not proven to be superior to rate control. Ablation-based rhythm control was compared with rate control to evaluate if clinical outcomes in patients with HF and AF could be improved. METHODS: This was a multicenter, open-label trial with blinded outcome evaluation using a central adjudication committee. Patients with high-burden paroxysmal (>4 episodes in 6 months) or persistent (duration <3 years) AF, New York Heart Association class II to III HF, and elevated NT-proBNP (N-terminal pro brain natriuretic peptide) were randomly assigned to ablation-based rhythm control or rate control. The primary outcome was a composite of all-cause mortality and all HF events, with a minimum follow-up of 2 years. Secondary outcomes included left ventricular ejection fraction, 6-minute walk test, and NT-proBNP. Quality of life was measured using the Minnesota Living With Heart Failure Questionnaire and the AF Effect on Quality of Life. The primary analysis was time-to-event using Cox proportional hazards modeling. The trial was stopped early because of a determination of apparent futility by the Data Safety Monitoring Committee. RESULTS: From December 1, 2011, to January 20, 2018, 411 patients were randomly assigned to ablation-based rhythm control (n=214) or rate control (n=197). The primary outcome occurred in 50 (23.4%) patients in the ablation-based rhythm-control group and 64 (32.5%) patients in the rate-control group (hazard ratio, 0.71 [95% CI, 0.49-1.03]; P=0.066). Left ventricular ejection fraction increased in the ablation-based group (10.1±1.2% versus 3.8±1.2%, P=0.017), 6-minute walk distance improved (44.9±9.1 m versus 27.5±9.7 m, P=0.025), and NT-proBNP demonstrated a decrease (mean change -77.1% versus -39.2%, P<0.0001). Minnesota Living With Heart Failure Questionnaire demonstrated greater improvement in the ablation-based rhythm-control group (least-squares mean difference of -5.4 [95% CI, -10.5 to -0.3]; P=0.0036), as did the AF Effect on Quality of Life score (least-squares mean difference of 6.2 [95% CI, 1.7-10.7]; P=0.0005). Serious adverse events were observed in 50% of patients in both treatment groups. CONCLUSIONS: In patients with high-burden AF and HF, there was no statistical difference in all-cause mortality or HF events with ablation-based rhythm control versus rate control; however, there was a nonsignificant trend for improved outcomes with ablation-based rhythm control over rate control. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT01420393.
Authors: Sahith R Thotamgari; Akhilesh Babbili; Roopesh S Jakulla; Mohammad A N Bhuiyan; Paari Dominic Journal: J Cardiovasc Electrophysiol Date: 2022-09-18 Impact factor: 2.942
Authors: Leonard Bergau; Philipp Bengel; Vanessa Sciacca; Thomas Fink; Christian Sohns; Philipp Sommer Journal: J Clin Med Date: 2022-04-29 Impact factor: 4.964
Authors: Michele Magnocavallo; Antonio Parlavecchio; Giampaolo Vetta; Carola Gianni; Marco Polselli; Francesco De Vuono; Luigi Pannone; Sanghamitra Mohanty; Filippo Maria Cauti; Rodolfo Caminiti; Vincenzo Miraglia; Cinzia Monaco; Gian-Battista Chierchia; Pietro Rossi; Luigi Di Biase; Stefano Bianchi; Carlo de Asmundis; Andrea Natale; Domenico Giovanni Della Rocca Journal: J Clin Med Date: 2022-09-21 Impact factor: 4.964