Volume 20, Issue 1 pp. 22-28

Catheter Ablation of Atrial Fibrillation in Patients with Diabetes Mellitus Type 2: Results from a Randomized Study Comparing Pulmonary Vein Isolation Versus Antiarrhythmic Drug Therapy

GIOVANNI B. FORLEO M.D., Ph.D.

GIOVANNI B. FORLEO M.D., Ph.D.

Cardiac Arrhythmia and Heart Failure Research Center, St. Camillo-Forlanini Hospital, Catholic University of Sacred Heart, Rome, Italy

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MASSIMO MANTICA M.D.

MASSIMO MANTICA M.D.

Arrhythmia and Electrophysiology Center, St. Ambrogio Clinical Institute, Milan, Italy

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LUCIA DE LUCA M.D., Ph.D.

LUCIA DE LUCA M.D., Ph.D.

Department of Internal Medicine, Division of Cardiology, University of Tor Vergata, Rome, Italy

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ROBERTO LEO M.D.

ROBERTO LEO M.D.

Department of Internal Medicine, Division of Cardiology, University of Tor Vergata, Rome, Italy

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LUCA SANTINI M.D.

LUCA SANTINI M.D.

Department of Internal Medicine, Division of Cardiology, University of Tor Vergata, Rome, Italy

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STEFANIA PANIGADA M.D.

STEFANIA PANIGADA M.D.

Arrhythmia and Electrophysiology Center, St. Ambrogio Clinical Institute, Milan, Italy

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VALERIO DE SANCTIS M.D.

VALERIO DE SANCTIS M.D.

Arrhythmia and Electrophysiology Center, St. Ambrogio Clinical Institute, Milan, Italy

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AUGUSTO PAPPALARDO M.D.

AUGUSTO PAPPALARDO M.D.

Cardiac Arrhythmia and Heart Failure Research Center, St. Camillo-Forlanini Hospital, Catholic University of Sacred Heart, Rome, Italy

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FRANCESCO LAURENZI M.D.

FRANCESCO LAURENZI M.D.

Cardiac Arrhythmia and Heart Failure Research Center, St. Camillo-Forlanini Hospital, Catholic University of Sacred Heart, Rome, Italy

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ANDREA AVELLA M.D.

ANDREA AVELLA M.D.

Cardiac Arrhythmia and Heart Failure Research Center, St. Camillo-Forlanini Hospital, Catholic University of Sacred Heart, Rome, Italy

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MICHELA CASELLA M.D.

MICHELA CASELLA M.D.

Cardiac Arrhythmia and Heart Failure Research Center, St. Camillo-Forlanini Hospital, Catholic University of Sacred Heart, Rome, Italy

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ANTONIO DELLO RUSSO M.D.

ANTONIO DELLO RUSSO M.D.

Cardiac Arrhythmia and Heart Failure Research Center, St. Camillo-Forlanini Hospital, Catholic University of Sacred Heart, Rome, Italy

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FRANCESCO ROMEO M.D.

FRANCESCO ROMEO M.D.

Department of Internal Medicine, Division of Cardiology, University of Tor Vergata, Rome, Italy

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GEMMA PELARGONIO M.D.

GEMMA PELARGONIO M.D.

Cardiac Arrhythmia and Heart Failure Research Center, St. Camillo-Forlanini Hospital, Catholic University of Sacred Heart, Rome, Italy

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CLAUDIO TONDO M.D., Ph.D.

CLAUDIO TONDO M.D., Ph.D.

Cardiac Arrhythmia and Heart Failure Research Center, St. Camillo-Forlanini Hospital, Catholic University of Sacred Heart, Rome, Italy

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First published: 29 December 2008
Citations: 123
Address for correspondence: Claudio Tondo, M.D., Ph.D., Chief, Cardiology Division, Director Cardiac Arrhythmia and Heart Failure Research Center, St. Camillo-Forlanini Hospital, Catholic University of Sacred Heart, Piazza Carlo Forlanini, 1. 00151, Rome, Italy. Fax: +39-06-58704520; E-mail: [email protected]

Dr. Tondo reports receiving lecture fees from St. Jude Medical and serving on the advisory board of Biosense-Webster.

Manuscript received 17 January 2008; Revised manuscript received 13 May 2008; Accepted for publication 10 June 2008.

Abstract

Introduction: Atrial fibrillation (AF) and diabetes mellitus type 2 (DM2) often coexist; however, a small number of patients with DM2 undergoing catheter ablation (CA) of AF have been included in previous studies. The aim of this study was to evaluate safety and efficacy of ablation therapy in DM2 patients with drug refractory AF.

Methods and Results: From January 2005 to September 2006, 70 patients with a diagnosis of DM2 and paroxysmal (n = 29) or persistent (n = 41) AF were randomized to receive either pulmonary vein isolation or a new antiarrhythmic drug treatment (ADT) with a 1-year follow-up. The primary endpoint was the time to first AF recurrence. By Kaplan-Meier analysis, at the end of follow-up, 42.9% of patients in the ADT group and 80% of patients who received a single ablation procedure and were without medications were free of AF (P = 0.001). In the ablation group, a significant improvement in quality-of-life (QoL) scores as compared with ADT group was observed. Six patients in the ADT group (17.1%) developed significant adverse drug effects. Hospitalization rate during follow-up was higher in the ADT group (P = 0.01). The only complication attributable to ablation was one significant access-site hematoma.

Conclusion: In patients with DM2, CA of AF provides significant clinical benefits over the ADT and appears to be a reasonable approach regarding feasibility, effectiveness, and low procedural risk.

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