Luigi Di Biase1, Prasant Mohanty1, Sanghamitra Mohanty1, Pasquale Santangeli1, Chintan Trivedi1, Dhanunjaya Lakkireddy1, Madhu Reddy1, Pierre Jais1, Sakis Themistoclakis1, Antonio Dello Russo1, Michela Casella1, Gemma Pelargonio1, Maria Lucia Narducci1, Robert Schweikert1, Petr Neuzil1, Javier Sanchez1, Rodney Horton1, Salwa Beheiry1, Richard Hongo1, Steven Hao1, Antonio Rossillo1, Giovanni Forleo1, Claudio Tondo1, J David Burkhardt1, Michel Haissaguerre1, Andrea Natale2. 1. From Texas Cardiac Arrhythmia Institute at St. David's Medical Center, Austin (L.D.B., P.M., S.M., P.S., C.T., J.S., R.H., J.D.B., A.N.); Albert Einstein College of Medicine, at Montefiore Hospital, New York, NY (L.D.B.); Department of Biomedical Engineering, University of Texas, Austin (L.D.B., A.N.); Department of Cardiology, University of Foggia, Italy (L.D.B.); University of Kansas, Kansas City (D.L., M.R.); Hôpital Cardiologique du Haut Lévêque, Université Victor-Segalen Bordeaux, France (P.J., M.H.); Ospedale dell'Angelo, Mestre Venice, Italy (S.T., A.R.); Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino IRCCS, Milan, Italy (A.D.R., M.C., C.T.); University of Sacred Heart, Rome, Italy (G.P., M.L.N.); Akron General Hospital, OH (R.S.); Department of Cardiology, Na Homolce Hospital, Prague, Czech Republic (P.N.); California Pacific Medical Center, San Francisco (S.B., R.H., S.H., A.N.); University of Tor Vergata, Rome, Italy (G.F.); Division of Cardiology, Stanford University, Palo Alto, CA (A.N.); Case Western Reserve University, Cleveland, OH (A.N.); Scripps Clinic, San Diego, CA (A.N.); and Dell Medical School, Austin, TX (A.N.). 2. From Texas Cardiac Arrhythmia Institute at St. David's Medical Center, Austin (L.D.B., P.M., S.M., P.S., C.T., J.S., R.H., J.D.B., A.N.); Albert Einstein College of Medicine, at Montefiore Hospital, New York, NY (L.D.B.); Department of Biomedical Engineering, University of Texas, Austin (L.D.B., A.N.); Department of Cardiology, University of Foggia, Italy (L.D.B.); University of Kansas, Kansas City (D.L., M.R.); Hôpital Cardiologique du Haut Lévêque, Université Victor-Segalen Bordeaux, France (P.J., M.H.); Ospedale dell'Angelo, Mestre Venice, Italy (S.T., A.R.); Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino IRCCS, Milan, Italy (A.D.R., M.C., C.T.); University of Sacred Heart, Rome, Italy (G.P., M.L.N.); Akron General Hospital, OH (R.S.); Department of Cardiology, Na Homolce Hospital, Prague, Czech Republic (P.N.); California Pacific Medical Center, San Francisco (S.B., R.H., S.H., A.N.); University of Tor Vergata, Rome, Italy (G.F.); Division of Cardiology, Stanford University, Palo Alto, CA (A.N.); Case Western Reserve University, Cleveland, OH (A.N.); Scripps Clinic, San Diego, CA (A.N.); and Dell Medical School, Austin, TX (A.N.). dr.natale@gmail.com.
Abstract
BACKGROUND: Whether catheter ablation (CA) is superior to amiodarone (AMIO) for the treatment of persistent atrial fibrillation (AF) in patients with heart failure is unknown. METHODS AND RESULTS: This was an open-label, randomized, parallel-group, multicenter study. Patients with persistent AF, dual-chamber implantable cardioverter defibrillator or cardiac resynchronization therapy defibrillator, New York Heart Association II to III, and left ventricular ejection fraction <40% within the past 6 months were randomly assigned (1:1 ratio) to undergo CA for AF (group 1, n=102) or receive AMIO (group 2, n=101). Recurrence of AF was the primary end point. All-cause mortality and unplanned hospitalization were the secondary end points. Patients were followed up for a minimum of 24 months. At the end of follow-up, 71 (70%; 95% confidence interval, 60%-78%) patients in group 1 were recurrence free after an average of 1.4±0.6 procedures in comparison with 34 (34%; 95% confidence interval, 25%-44%) in group 2 (log-rank P<0.001). The success rate of CA in the different centers after a single procedure ranged from 29% to 61%. After adjusting for covariates in the multivariable model, AMIO therapy was found to be significantly more likely to fail (hazard ratio, 2.5; 95% confidence interval, 1.5-4.3; P<0.001) than CA. Over the 2-year follow-up, the unplanned hospitalization rate was (32 [31%] in group 1 and 58 [57%] in group 2; P<0.001), showing 45% relative risk reduction (relative risk, 0.55; 95% confidence interval, 0.39-0.76). A significantly lower mortality was observed in CA (8 [8%] versus AMIO (18 [18%]; P=0.037). CONCLUSIONS: This multicenter randomized study shows that CA of AF is superior to AMIO in achieving freedom from AF at long-term follow-up and reducing unplanned hospitalization and mortality in patients with heart failure and persistent AF. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00729911.
RCT Entities:
BACKGROUND: Whether catheter ablation (CA) is superior to amiodarone (AMIO) for the treatment of persistent atrial fibrillation (AF) in patients with heart failure is unknown. METHODS AND RESULTS: This was an open-label, randomized, parallel-group, multicenter study. Patients with persistent AF, dual-chamber implantable cardioverter defibrillator or cardiac resynchronization therapy defibrillator, New York Heart Association II to III, and left ventricular ejection fraction <40% within the past 6 months were randomly assigned (1:1 ratio) to undergo CA for AF (group 1, n=102) or receive AMIO (group 2, n=101). Recurrence of AF was the primary end point. All-cause mortality and unplanned hospitalization were the secondary end points. Patients were followed up for a minimum of 24 months. At the end of follow-up, 71 (70%; 95% confidence interval, 60%-78%) patients in group 1 were recurrence free after an average of 1.4±0.6 procedures in comparison with 34 (34%; 95% confidence interval, 25%-44%) in group 2 (log-rank P<0.001). The success rate of CA in the different centers after a single procedure ranged from 29% to 61%. After adjusting for covariates in the multivariable model, AMIO therapy was found to be significantly more likely to fail (hazard ratio, 2.5; 95% confidence interval, 1.5-4.3; P<0.001) than CA. Over the 2-year follow-up, the unplanned hospitalization rate was (32 [31%] in group 1 and 58 [57%] in group 2; P<0.001), showing 45% relative risk reduction (relative risk, 0.55; 95% confidence interval, 0.39-0.76). A significantly lower mortality was observed in CA (8 [8%] versus AMIO (18 [18%]; P=0.037). CONCLUSIONS: This multicenter randomized study shows that CA of AF is superior to AMIO in achieving freedom from AF at long-term follow-up and reducing unplanned hospitalization and mortality in patients with heart failure and persistent AF. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00729911.
Authors: Hugh Calkins; Gerhard Hindricks; Riccardo Cappato; Young-Hoon Kim; Eduardo B Saad; Luis Aguinaga; Joseph G Akar; Vinay Badhwar; Josep Brugada; John Camm; Peng-Sheng Chen; Shih-Ann Chen; Mina K Chung; Jens Cosedis Nielsen; Anne B Curtis; D Wyn Davies; John D Day; André d'Avila; N M S Natasja de Groot; Luigi Di Biase; Mattias Duytschaever; James R Edgerton; Kenneth A Ellenbogen; Patrick T Ellinor; Sabine Ernst; Guilherme Fenelon; Edward P Gerstenfeld; David E Haines; Michel Haissaguerre; Robert H Helm; Elaine Hylek; Warren M Jackman; Jose Jalife; Jonathan M Kalman; Josef Kautzner; Hans Kottkamp; Karl Heinz Kuck; Koichiro Kumagai; Richard Lee; Thorsten Lewalter; Bruce D Lindsay; Laurent Macle; Moussa Mansour; Francis E Marchlinski; Gregory F Michaud; Hiroshi Nakagawa; Andrea Natale; Stanley Nattel; Ken Okumura; Douglas Packer; Evgeny Pokushalov; Matthew R Reynolds; Prashanthan Sanders; Mauricio Scanavacca; Richard Schilling; Claudio Tondo; Hsuan-Ming Tsao; Atul Verma; David J Wilber; Teiichi Yamane Journal: Heart Rhythm Date: 2017-05-12 Impact factor: 6.343
Authors: Fabiana G Marcondes-Braga; Lídia Ana Zytynski Moura; Victor Sarli Issa; Jefferson Luis Vieira; Luis Eduardo Rohde; Marcus Vinícius Simões; Miguel Morita Fernandes-Silva; Salvador Rassi; Silvia Marinho Martins Alves; Denilson Campos de Albuquerque; Dirceu Rodrigues de Almeida; Edimar Alcides Bocchi; Felix José Alvarez Ramires; Fernando Bacal; João Manoel Rossi Neto; Luiz Claudio Danzmann; Marcelo Westerlund Montera; Mucio Tavares de Oliveira Junior; Nadine Clausell; Odilson Marcos Silvestre; Reinaldo Bulgarelli Bestetti; Sabrina Bernadez-Pereira; Aguinaldo F Freitas; Andréia Biolo; Antonio Carlos Pereira Barretto; Antônio José Lagoeiro Jorge; Bruno Biselli; Carlos Eduardo Lucena Montenegro; Edval Gomes Dos Santos Júnior; Estêvão Lanna Figueiredo; Fábio Fernandes; Fabio Serra Silveira; Fernando Antibas Atik; Flávio de Souza Brito; Germano Emílio Conceição Souza; Gustavo Calado de Aguiar Ribeiro; Humberto Villacorta; João David de Souza Neto; Livia Adams Goldraich; Luís Beck-da-Silva; Manoel Fernandes Canesin; Marcelo Imbroinise Bittencourt; Marcely Gimenes Bonatto; Maria da Consolação Vieira Moreira; Mônica Samuel Avila; Otavio Rizzi Coelho Filho; Pedro Vellosa Schwartzmann; Ricardo Mourilhe-Rocha; Sandrigo Mangini; Silvia Moreira Ayub Ferreira; José Albuquerque de Figueiredo Neto; Evandro Tinoco Mesquita Journal: Arq Bras Cardiol Date: 2021-06 Impact factor: 2.000