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CLINICAL RESEARCH: HEART RHYTHM DISORDERS

Pulmonary Vein Antral Isolation Using an Open Irrigation Ablation Catheter for the Treatment of Atrial Fibrillation

A Randomized Pilot Study

Mohamed H. Kanj, MD^_*, Oussama Wazni, MD^_*, Tamer Fahmy, MD, PhD^_*, Sergio Thal, MD^_*, Dimpi Patel, MD^_*, Claude Elay, MD^_*, Luigi Di Biase, MD^_*,, Mauricio Arruda, MD^_*, Walid Saliba, MD^_*, Robert A. Schweikert, MD^_*, Jennifer E. Cummings, MD^_*, J. David Burkhardt, MD^_*, David O. Martin, MD^_*, Gemma Pelargonio, MD, Antonio Dello Russo, MD, Michela Casella, MD, Pietro Santarelli, MD, Domenico Potenza, MD^||, Raffaele Fanelli, MD^||, Raimondo Massaro, MD^||, Giovanni Forleo, MD^|| and Andrea Natale, MD^_*,_*

^_* Cleveland Clinic, Cleveland, Ohio
University of Insubria, Varese, Italy
Catholic University, Rome, Italy
Catholic University, Campobasso, Italy
^|| Casa Sollievo Della Sofferenza, San Giovanni Rotondo, Italy

Manuscript received August 29, 2006; revised manuscript received December 18, 2006, accepted December 19, 2006.

^_* Reprint requests and correspondence to: Dr. Andrea Natale, Section of Cardiac Electrophysiology and Pacing, Center for Atrial Fibrillation, Department of Cardiovascular Medicine, Cleveland Clinic, 9500 Euclid Avenue F15, Cleveland, Ohio 44195. (Email: natalea{at}ccf.org).

Objectives: We sought to test how catheter ablation using an open irrigation catheter (OIC) compares with standard catheters for pulmonary vein antrum isolation.

Background: Open irrigation catheters have the advantage of delivering greater power without increasing the temperature of the catheter tip, which enables deeper and wider lesions without the formation of coagulum on catheters.

Methods: Catheter ablation was performed using an 8-mm catheter (8MC) or an OIC. Patients were randomized to 3 groups: 8MC; OIC-1, OIC with a higher peak power (50 W); and OIC-2, OIC with lower peak power (35 W).

Results: A total of 180 patients were randomized to the 3 treatment strategies. Isolation of pulmonary vein antra was achieved in all patients. The freedom from atrial fibrillation was significantly greater in the 8MC and OIC-1 groups compared with the OIC-2 group (78%, 82%, and 68%, respectively, p = 0.043). Fluoroscopy time was lower in OIC-1 compared with OIC-2 and 8MC (28 ± 1 min, 53 ± 2 min, and 46 ± 2 min, respectively, p = 0.001). The mean left atrium instrumentation time was lower in the OIC-1 compared with the OIC-2 and 8MC groups (59 ± 3 min, 90 ± 5 min, and 88 ± 4 min, respectively, p = 0.001). However, there was a greater incidence of "pops" in the OIC-1 (100%, 0%, 0%, p < 0.001) along with higher incidences of pericardial effusion (20%, 0%, 0%, p < 0.001) and gastrointestinal complaints (17% in OIC-1, 3% in 8MC, and 5% in OIC-2, p = 0.031).

Conclusions: Although there was a decrease in fluoroscopy and left atrium instrumentation time with the use of OIC at higher power, this setting was associated with increased cardiovascular and gastrointestinal complications.

Abbreviations and Acronyms   AF = atrial fibrillation   ET = esophageal temperature   ICE = intracardiac echocardiography   LA = left atrium   OIC = open irrigation catheter   PV = pulmonary vein   PVAI = pulmonary vein antrum isolation   RF = radiofrequency   8MC = 8-mm catheter

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