Luigi Di Biase1, J David Burkhardt2, Prasant Mohanty2, Sanghamitra Mohanty2, Javier E Sanchez2, Chintan Trivedi2, Mahmut Güneş2, Yalçın Gökoğlan2, Carola Gianni2, Rodney P Horton2, Sakis Themistoclakis3, G Joseph Gallinghouse2, Shane Bailey2, Jason D Zagrodzky2, Richard H Hongo4, Salwa Beheiry4, Pasquale Santangeli5, Michela Casella6, Antonio Dello Russo6, Amin Al-Ahmad2, Patrick Hranitzky2, Dhanunjaya Lakkireddy7, Claudio Tondo6, Andrea Natale8. 1. Texas Cardiac Arrhythmia Institute at St. David's Medical Center, Austin, Texas; Albert Einstein College of Medicine at Montefiore Hospital, New York, New York; Department of Biomedical Engineering, University of Texas, Austin, Texas; Department of Cardiology, University of Foggia, Foggia, Italy. 2. Texas Cardiac Arrhythmia Institute at St. David's Medical Center, Austin, Texas. 3. Ospedale dell'Angelo, Mestre, Venice, Italy. 4. California Pacific Medical Center, San Francisco, California. 5. Texas Cardiac Arrhythmia Institute at St. David's Medical Center, Austin, Texas; Department of Cardiology, University of Foggia, Foggia, Italy. 6. Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino IRCCS, Milan, Italy. 7. Section of Electrophysiology, University of Kansas, Kansas City, Missouri. 8. Texas Cardiac Arrhythmia Institute at St. David's Medical Center, Austin, Texas; Department of Biomedical Engineering, University of Texas, Austin, Texas; Division of Cardiology, Stanford University, Palo Alto, California; Section of Electrophysiology, Case Western Reserve University, Cleveland, Ohio; Interventional Electrophysiology, Scripps Clinic, San Diego, California; Department of Medicine, Dell Medical School, Austin, Texas. Electronic address: dr.natale@gmail.com.
Abstract
BACKGROUND:Longstanding persistent (LSP) atrial fibrillation (AF) is the most challenging type of AF. In addition to pulmonary vein isolation, substrate modification and triggers ablation have been reported to improve freedom from AF in patients with LSPAF. OBJECTIVES: This study sought to assess whether the empirical electrical isolation of the left atrial appendage (LAA) could improve success at follow-up. METHODS: This was an open-label, randomized study assessing the effectiveness of empirical electrical left atrial appendage isolation for the treatment of LSPAF. Patients were randomly assigned to undergo empirical electrical left atrial appendage isolation along with extensive ablation (group 1; n = 85) or extensive ablation alone (group 2; n = 88). Recurrence of atrial arrhythmias was the primary endpoint. Secondary endpoints included cardiac-related hospitalization, all-cause mortality, and stroke at follow-up. RESULTS: Major clinical characteristics were not different between the 2 groups. At 12-month follow-up, 48 (56%) patients in group 1 and 25 (28%) in group 2 were recurrence free after a single procedure (unadjusted hazard ratio [HR] for recurrence with standard ablation: 1.92; 95% confidence interval [CI]: 1.3 to 2.9; log-rank p = 0.001). After adjusting for age, sex, and left atrial size, standard ablation was predictive of recurrence (HR: 2.22; 95% CI: 1.29 to 3.81; p = 0.004). During repeat procedures, empirical electrical left atrial appendage isolation was performed in all patients. After an average of 1.3 procedures, cumulative success at 24-month follow-up was reported in 65 (76%) in group 1 and in 49 (56%) in group 2 (unadjusted HR: 2.24; 95% CI: 1.3 to 3.8; log-rank p = 0.003). CONCLUSIONS: This randomized study showed that both after a single procedure and after redo procedures in patients with LSPAF, empirical electrical isolation of the LAA improved long-term freedom from atrial arrhythmias without increasing complications. (Effect of Empirical Left Atrial Appendage Isolation on Long-term Procedure Outcome in Patients With Persistent or Longstanding Persistent Atrial Fibrillation Undergoing Catheter Ablation [BELIEF]; NCT01362738).
RCT Entities:
BACKGROUND: Longstanding persistent (LSP) atrial fibrillation (AF) is the most challenging type of AF. In addition to pulmonary vein isolation, substrate modification and triggers ablation have been reported to improve freedom from AF in patients with LSPAF. OBJECTIVES: This study sought to assess whether the empirical electrical isolation of the left atrial appendage (LAA) could improve success at follow-up. METHODS: This was an open-label, randomized study assessing the effectiveness of empirical electrical left atrial appendage isolation for the treatment of LSPAF. Patients were randomly assigned to undergo empirical electrical left atrial appendage isolation along with extensive ablation (group 1; n = 85) or extensive ablation alone (group 2; n = 88). Recurrence of atrial arrhythmias was the primary endpoint. Secondary endpoints included cardiac-related hospitalization, all-cause mortality, and stroke at follow-up. RESULTS: Major clinical characteristics were not different between the 2 groups. At 12-month follow-up, 48 (56%) patients in group 1 and 25 (28%) in group 2 were recurrence free after a single procedure (unadjusted hazard ratio [HR] for recurrence with standard ablation: 1.92; 95% confidence interval [CI]: 1.3 to 2.9; log-rank p = 0.001). After adjusting for age, sex, and left atrial size, standard ablation was predictive of recurrence (HR: 2.22; 95% CI: 1.29 to 3.81; p = 0.004). During repeat procedures, empirical electrical left atrial appendage isolation was performed in all patients. After an average of 1.3 procedures, cumulative success at 24-month follow-up was reported in 65 (76%) in group 1 and in 49 (56%) in group 2 (unadjusted HR: 2.24; 95% CI: 1.3 to 3.8; log-rank p = 0.003). CONCLUSIONS: This randomized study showed that both after a single procedure and after redo procedures in patients with LSPAF, empirical electrical isolation of the LAA improved long-term freedom from atrial arrhythmias without increasing complications. (Effect of Empirical Left Atrial Appendage Isolation on Long-term Procedure Outcome in Patients With Persistent or Longstanding Persistent Atrial Fibrillation Undergoing Catheter Ablation [BELIEF]; NCT01362738).
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: Kenneth Kita; Steven Carlson; Mary Huntsinger; Han Tun; Jina Sohn; Rahul N Doshi Journal: J Interv Card Electrophysiol Date: 2019-08-03 Impact factor: 1.900