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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

View larger version (43K): [in a new window]   Figure 1 Three-dimensional left atrial (LA) voltage maps (posteroanterior view: left, preablation; right, postablation), depicting peak-to-peak bipolar electrogram amplitude. Color red represents lowest voltage, and purple, highest voltage. Claret red spheres represent radiofrequency lesions. In postablation, areas within and around the ablation lines, involving to some extent the LA posterior wall, show low-amplitude (<0.1 mV) electrograms. Preablation insets show pulmonary vein (PV) ostial potentials indicating the activation of muscular fibers capable of conducting impulses in or out of the veins. By creation of lesions around each vein ostium, PV potentials are no longer detected (insets) at the same ostial points recorded before ablation. LSPV = left superior pulmonary vein; LIPV = left inferior pulmonary vein; RSPV = right superior pulmonary vein; RIPV = right inferior pulmonary vein.

View larger version (17K): [in a new window]   Figure 2 Observed and expected survival in the ablation and medical groups. The observed survival among ablation patients did not differ (p = 0.55) from the expected (A) and was significantly longer than that observed in the medical group, whose survival proved worse than that expected (B). Observed survival probabilities were 98%, 95%, and 92% at one, two, and three years, respectively, among ablated patients, and 96%, 90%, and 86%, respectively, among those medically treated (p < 0.001).

View larger version (17K): [in a new window]   Figure 3 The hazard ratios (HRs) and 95% confidence intervals (CIs) for the risk of death, adverse events, and atrial fibrillation (AF) recurrence in the ablation group as compared with the medical group. In A and B, for each covariate, the corresponding HR and 95% CI are represented before (blue line) and after (red line) the introduction into the Cox model of maintenance of sinus rhythm (SR) as time-dependent variables. There was evidence of nonproportional hazards between the two treatment groups over time (p < 0.001) for recurrent AF, with a significant treatment interaction (p < 0.001); the corresponding HR for ablation was 0.30 (95% CI, 0.24 to 0.37) and must be interpreted as an average value during the entire follow-up period (C), as well as the other HRs indicated by asterisks (*) in A and B. By entering maintenance of SR, ablation patients’ HRs for the risk of all-cause death and adverse events went from 0.46 (95% CI, 0.31 to 0.68; p < 0.001) and 0.45 (95% CI, 0.31 to 0.64; p < 0.001) to 0.66 (95% CI, 0.44 to 0.97; p = 0.04) and 0.61 (95% CI, 0.42 to 0.86; p = 0.007), respectively. CAD = coronary artery disease; EF = ejection fraction; LA = left atrial; LV = left ventricular; TIA = transient ischemic attack.

View larger version (13K): [in a new window]   Figure 4 Kaplan-Meier estimates of the percentages of patients remaining free of any adverse events. Percentages of patients event-free were 97%, 94%, and 91% at one, two, and three years, respectively, among ablated patients, and 93%, 87%, and 81%, respectively, among those medically treated (p < 0.001).

View larger version (17K): [in a new window]   Figure 5 Kaplan-Meier estimates of the percentages of patients remaining free of atrial fibrillation (AF) recurrence. Percentages of AF-free patients were 84%, 79%, and 78%, respectively, at one, two, and three years among ablated patients, and 61%, 47%, and 37%, respectively, among those medically treated (p < 0.001). The favorable effect of ablation on AF recurrence increased over time during the entire follow-up period, with an average risk of 0.30 (inset).

View larger version (14K): [in a new window]   Figure 6 Changes in quality of life over time in the ablation and medical groups. The computation of aggregate scores for the physical (PCS, A) and mental (MCS, B) components and missing data were handled as suggested by the developers of the SF-36 (15).