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CLINICAL RESEARCH: CLINICAL TRIALS

Mortality, morbidity, and quality of life after circumferential pulmonary vein ablation for atrial fibrillation

Outcomes from a controlled nonrandomized long-term study

Carlo Pappone, MD, PhD^*,*, Salvatore Rosanio, MD, PhD^*, Giuseppe Augello, MD^*, Giuseppe Gallus, PhD, Gabriele Vicedomini, MD^*, Patrizio Mazzone, MD^*, Simone Gulletta, MD^*, Filippo Gugliotta, RT^*, Alessia Pappone, MD^*, Vincenzo Santinelli, MD^*, Valter Tortoriello, MD^*, Simone Sala, MD^*, Alberto Zangrillo, MD, Giuseppe Crescenzi, MD, Stefano Benussi, MD and Ottavio Alfieri, MD

^* Clinical Cardiac Electrophysiology and Pacing Unit, Department of Cardiology, San Raffaele University Hospital, Milan, Italy
Institute of Medical Statistics, University of Milan, Milan, Italy
Division of Anesthesiology and Intensive Care, San Raffaele University Hospital, Milan, Italy
Cardiothoracic Surgery Unit, Department of Cardiology, San Raffaele University Hospital, Milan, Italy

Manuscript received October 25, 2002; revised manuscript received January 23, 2003, accepted January 30, 2003.

^* Reprint requests and correspondence: Dr. Carlo Pappone, Department of Cardiology, San Raffaele University Hospital, Via Olgettina 60, 20132 Milan, Italy.
salvatore.rosanio{at}hsr.it

Presented in part at the 75th Annual Scientific Sessions of the American Heart Association, November 2002, and 52nd Annual Scientific Sessions of the American College of Cardiology, March 2003.

OBJECTIVES: This study was designed to investigate the potential of circumferential pulmonary vein (PV) ablation for atrial fibrillation (AF) to maintain sinus rhythm (SR) over time, thus reducing mortality and morbidity while enhancing quality of life (QoL).

BACKGROUND: Circumferential PV ablation is safe and effective, but the long-term outcomes and its impact on QoL have not been assessed or compared with those for medical therapy.

METHODS: We examined the clinical course of 1,171 consecutive patients with symptomatic AF who were referred to us between January 1998 and March 2001. The 589 ablated patients were compared with the 582 who received antiarrhythmic medications for SR control. The QoL of 109 ablated and 102 medically treated patients was measured with the SF-36 survey.

RESULTS: Median follow-up was 900 days (range 161 to 1,508 days). Kaplan-Meier analysis showed observed survival for ablated patients was longer than among patients treated medically (p < 0.001), and not different from that expected for healthy persons of the same gender and calendar year of birth (p = 0.55). Cox proportional-hazards model revealed in the ablation group hazard ratios of 0.46 (95% confidence interval [CI], 0.31 to 0.68; p < 0.001) for all-cause mortality, of 0.45 (95% CI, 0.31 to 0.64; p < 0.001) for morbidities mainly due to heart failure and ischemic cerebrovascular events, and of 0.30 (95% CI, 0.24 to 0.37; p < 0.001) for AF recurrence. Ablated patients’ QoL, different from patients treated medically, reached normative levels at six months and remained unchanged at one year.

CONCLUSIONS: Pulmonary vein ablation improves mortality, morbidity, and QoL as compared with medical therapy. Our findings pave the way for randomized trials to prospect a wider application of ablation therapy for AF.

Abbreviations and Acronyms   AF = atrial fibrillation   CAD = coronary artery disease   CI = confidence interval   ECG = electrocardiogram   HR = hazard ratio   LA = left atrial/atrium   MI = myocardial infarction   PV = pulmonary vein   QoL = quality of life   RF = radiofrequency   SR = sinus rhythm

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