Pulmonary-Vein Isolation for Atrial Fibrillation in Patients with Heart Failure

Khan, Mohammed N. M.D.
Jaïs, Pierre M.D.
Cummings, Jennifer M.D.
Di Biase, Luigi M.D.
Sanders, Prashanthan M.D.
Martin, David O. M.D.
Kautzner, Josef M.D.
Hao, Steven M.D.
Themistoclakis, Sakis M.D.
Fanelli, Raffaele M.D.
Potenza, Domenico M.D.
Massaro, Raimondo M.D.
Wazni, Oussama M.D.
Schweikert, Robert M.D.
Saliba, Walid M.D.
Wang, Paul M.D.
Al-Ahmad, Amin M.D.
Beheiry, Salwa M.D.
Santarelli, Pietro M.D.
Starling, Randall C. M.D.
Russo, Antonio Dello M.D.
Pelargonio, Gemma M.D.
Brachmann, Johannes M.D.
Schibgilla, Volker M.D.
Bonso, Aldo M.D.
Casella, Michela M.D.
Raviele, Antonio M.D.
Haïssaguerre, Michel M.D.
Natale, Andrea M.D.

From Cardiovascular Associates, Elk Grove Village, IL (M.N.K.); Hôpital Cardiologique du Haut-Leveque, Bordeaux, France (P.J., M.H.); Cleveland Clinic, Cleveland (J.C., L.D.B., D.O.M., O.W., R.S., W.S., R.C.S.); University of Foggia, Foggia (L.D.B.), Umberto I Hospital, Mestre-Venice (S.T., A.B., M.C., A.R.), Casa Sollievo della Sofferenza, San Giovanni Rotondo (R.F., D.P., R.M.), Catholic University, Campobasso (P. Santarelli), and Catholic University of the Sacred Heart Rome, Rome (A.D.R., G.P.) — all in Italy; Royal Adelaide Hospital, Adelaide, Australia (P. Sanders); Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); Sutter Pacific Heart Centers, San Francisco (S.H., S.B.); Stanford University Medical Center, Stanford, CA (P.W., A.A.-A., A.N.); Klinikum Coburg, Coburg, Germany (J.B., V.S.); and Texas Cardiac Arrhythmia Institute at St. David's Medical Center, Austin, and Case Western Reserve University, Cleveland (A.N.). Address reprint requests to Dr. Khan at Cardiovascular Associates, 701 Biesterfield Rd., Elk Grove Village, IL 60007, or at [email protected].
*PABA-CHF denotes the Pulmonary Vein Antrum Isolation versus AV Node Ablation with Bi-Ventricular Pacing for Treatment of Atrial Fibrillation in Patients with Congestive Heart Failure study.

Supported by a grant (257-2) from the Ministry of Education, Youth, and Sports of the Czech Republic and by a St. Jude Medical Educational Grant.

Dr. Khan reports receiving lecture fees from Boston Scientific; Dr. Jaïs, consulting fees from St. Jude Medical, Sorin Medical, and Biosense Webster; Dr. Cummings, consulting fees from St. Jude Medical and lecture fees from Boston Scientific, Medtronic, Corazon, Biosense Webster, and Siemens; Dr. Sanders, consulting fees from Medtronic and St. Jude Medical and lecture fees from St. Jude Medical, Biosense Webster, and Bard Electrophysiology; Dr. Kautzner, consulting and lecture fees from Boston Scientific, Biosense Webster, Medtronic, and St. Jude Medical; Dr. Wazni, lecture fees from St. Jude Medical; Dr. Schweikert, lecture fees from Medtronic, Biotronik, St. Jude Medical, Boston Scientific, Reliant Pharmaceuticals, Biosense Webster, and Siemens; and Dr. Saliba, lecture fees from Medtronic, Boston Scientific, and St. Jude Medical. Dr. Wang reports receiving consulting fees from Lifewatch, lecture fees from Boston Scientific, Medtronic, and St. Jude, and research support from Boston Scientific and having equity interest in Hansen Medical. Dr. Starling reports receiving consulting fees from Medtronic and BioControl and research support from Medtronic and having equity interest in Cardiomems. Dr. Haïssaguerre reports receiving lecture fees from Biosense Webster and Bard Electrophysiology and research support from Boston Scientific. No other potential conflict of interest relevant to this article was reported.

New England Journal of Medicine 359(17):p 1778-1785, October 23, 2008. | DOI: 10.1056/NEJMoa0708234

Background

Pulmonary-vein isolation is increasingly being used to treat atrial fibrillation in patients with heart failure.

Methods

In this prospective, multicenter clinical trial, we randomly assigned patients with symptomatic, drug-resistant atrial fibrillation, an ejection fraction of 40% or less, and New York Heart Association class II or III heart failure to undergo either pulmonary-vein isolation or atrioventricular-node ablation with biventricular pacing. All patients completed the Minnesota Living with Heart Failure questionnaire (scores range from 0 to 105, with a higher score indicating a worse quality of life) and underwent echocardiography and a 6-minute walk test (the composite primary end point). Over a 6-month period, patients were monitored for both symptomatic and asymptomatic episodes of atrial fibrillation.

Results

In all, 41 patients underwent pulmonary-vein isolation, and 40 underwent atrioventricular-node ablation with biventricular pacing; none were lost to follow-up at 6 months. The composite primary end point favored the group that underwent pulmonary-vein isolation, with an improved questionnaire score at 6 months (60, vs. 82 in the group that underwent atrioventricular-node ablation with biventricular pacing; P<0.001), a longer 6-minute-walk distance (340 m vs. 297 m, P<0.001), and a higher ejection fraction (35% vs. 28%, P<0.001). In the group that underwent pulmonary-vein isolation, 88% of patients receiving antiarrhythmic drugs and 71% of those not receiving such drugs were free of atrial fibrillation at 6 months. In the group that underwent pulmonary-vein isolation, pulmonary-vein stenosis developed in two patients, pericardial effusion in one, and pulmonary edema in another; in the group that underwent atrioventricular-node ablation with biventricular pacing, lead dislodgment was found in one patient and pneumothorax in another.

Conclusions

Pulmonary-vein isolation was superior to atrioventricular-node ablation with biventricular pacing in patients with heart failure who had drug-refractory atrial fibrillation. (ClinicalTrials.gov number, NCT00599976.)