OBJECTIVES: This study sought to compare catheter ablation with rate control for persistent atrial fibrillation (AF) in heart failure (HF). BACKGROUND: The optimal therapy for AF in HF is unclear. Drug-based rhythm control has not proved clinically beneficial. Catheter ablation improves cardiac function in patients with HF, but impact on physiological performance has not been formally evaluated in a randomized trial. METHODS: In a randomized, open-label, blinded-endpoint clinical trial, adults with symptomatic HF, radionuclide left ventricular ejection fraction (EF) ≤35%, and persistent AF were assigned to undergo catheter ablation or rate control. Primary outcome was 12-month change in peak oxygen consumption. Secondary endpoints were quality of life, B-type natriuretic peptide, 6-min walk distance, and EF. Results were analyzed by intention-to-treat. RESULTS:Fifty-two patients (age 63 ± 9 years, EF 24 ± 8%) were randomized, 26 each to ablation and rate control. At 12 months, 88% of ablation patients maintained sinus rhythm (single-procedure success 68%). Under rate control, rate criteria were achieved in 96%. The primary endpoint, peak oxygen consumption, significantly increased in the ablation arm compared with rate control (difference +3.07 ml/kg/min, 95% confidence interval: 0.56 to 5.59, p = 0.018). The change was not evident at 3 months (+0.79 ml/kg/min, 95% confidence interval: -1.01 to 2.60, p = 0.38). Ablation improved Minnesota score (p = 0.019) and B-type natriuretic peptide (p = 0.045) and showed nonsignificant trends toward improved 6-min walk distance (p = 0.095) and EF (p = 0.055). CONCLUSIONS: This first randomized trial of ablation versus rate control to focus on objective exercise performance in AF and HF shows significant benefit from ablation, a strategy that also improves symptoms and neurohormonal status. The effects develop over 12 months, consistent with progressive amelioration of the HF syndrome. (A Randomised Trial to Assess Catheter Ablation Versus Rate Control in the Management of Persistent Atrial Fibrillation in Chronic Heart Failure; NCT00878384).
RCT Entities:
OBJECTIVES: This study sought to compare catheter ablation with rate control for persistent atrial fibrillation (AF) in heart failure (HF). BACKGROUND: The optimal therapy for AF in HF is unclear. Drug-based rhythm control has not proved clinically beneficial. Catheter ablation improves cardiac function in patients with HF, but impact on physiological performance has not been formally evaluated in a randomized trial. METHODS: In a randomized, open-label, blinded-endpoint clinical trial, adults with symptomatic HF, radionuclide left ventricular ejection fraction (EF) ≤35%, and persistent AF were assigned to undergo catheter ablation or rate control. Primary outcome was 12-month change in peak oxygen consumption. Secondary endpoints were quality of life, B-type natriuretic peptide, 6-min walk distance, and EF. Results were analyzed by intention-to-treat. RESULTS: Fifty-two patients (age 63 ± 9 years, EF 24 ± 8%) were randomized, 26 each to ablation and rate control. At 12 months, 88% of ablation patients maintained sinus rhythm (single-procedure success 68%). Under rate control, rate criteria were achieved in 96%. The primary endpoint, peak oxygen consumption, significantly increased in the ablation arm compared with rate control (difference +3.07 ml/kg/min, 95% confidence interval: 0.56 to 5.59, p = 0.018). The change was not evident at 3 months (+0.79 ml/kg/min, 95% confidence interval: -1.01 to 2.60, p = 0.38). Ablation improved Minnesota score (p = 0.019) and B-type natriuretic peptide (p = 0.045) and showed nonsignificant trends toward improved 6-min walk distance (p = 0.095) and EF (p = 0.055). CONCLUSIONS: This first randomized trial of ablation versus rate control to focus on objective exercise performance in AF and HF shows significant benefit from ablation, a strategy that also improves symptoms and neurohormonal status. The effects develop over 12 months, consistent with progressive amelioration of the HF syndrome. (A Randomised Trial to Assess Catheter Ablation Versus Rate Control in the Management of Persistent Atrial Fibrillation in Chronic Heart Failure; NCT00878384).
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: Liang-Han Ling; Peter M Kistler; Jonathan M Kalman; Richard J Schilling; Ross J Hunter Journal: Nat Rev Cardiol Date: 2015-12-10 Impact factor: 32.419
Authors: Shadi Al Halabi; Mohammed Qintar; Ayman Hussein; M Chadi Alraies; David G Jones; Tom Wong; Michael R MacDonald; Mark C Petrie; Daniel Cantillon; Khaldoun G Tarakji; Mohamed Kanj; Mandeep Bhargava; Niraj Varma; Bryan Baranowski; Bruce L Wilkoff; Oussama Wazni; Thomas Callahan; Walid Saliba; Mina K Chung Journal: JACC Clin Electrophysiol Date: 2015-06-01