Comparison of Cool Tip Versus 8-mm Tip Catheter in Achieving Electrical Isolation of Pulmonary Veins for Long-Term Control of Atrial Fibrillation: A Prospective Randomized Pilot Study

Authors

  • SANJAY DIXIT M.D.,

    1. Cardiovascular Division, Hospital of The University of Pennsylvania and Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, Pennsylvania, USA
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  • EDWARD P. GERSTENFELD M.D.,

    1. Cardiovascular Division, Hospital of The University of Pennsylvania and Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, Pennsylvania, USA
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  • DAVID J. CALLANS M.D.,

    1. Cardiovascular Division, Hospital of The University of Pennsylvania and Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, Pennsylvania, USA
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  • JOSHUA M. COOPER M.D.,

    1. Cardiovascular Division, Hospital of The University of Pennsylvania and Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, Pennsylvania, USA
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  • DAVID LIN M.D.,

    1. Cardiovascular Division, Hospital of The University of Pennsylvania and Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, Pennsylvania, USA
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  • ANDREA M. RUSSO M.D.,

    1. Cardiovascular Division, Hospital of The University of Pennsylvania and Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, Pennsylvania, USA
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  • RALPH J. VERDINO M.D.,

    1. Cardiovascular Division, Hospital of The University of Pennsylvania and Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, Pennsylvania, USA
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  • VICKAS V. PATEL M.D., Ph.D.,

    1. Cardiovascular Division, Hospital of The University of Pennsylvania and Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, Pennsylvania, USA
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  • STEPHEN E. KIMMEL M.D., M.S.C.E.,

    1. Cardiovascular Division, Hospital of The University of Pennsylvania and Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, Pennsylvania, USA
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  • SARAH J. RATCLIFFE Ph.D. ,

    1. Cardiovascular Division, Hospital of The University of Pennsylvania and Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, Pennsylvania, USA
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  • HENRY H. HSIA M.D.,

    1. Cardiovascular Division, Hospital of The University of Pennsylvania and Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, Pennsylvania, USA
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  • HEMAL M. NAYAK M.D.,

    1. Cardiovascular Division, Hospital of The University of Pennsylvania and Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, Pennsylvania, USA
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  • ERICA ZADO P.A.,

    1. Cardiovascular Division, Hospital of The University of Pennsylvania and Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, Pennsylvania, USA
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  • JIAN-FANG REN M.D.,

    1. Cardiovascular Division, Hospital of The University of Pennsylvania and Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, Pennsylvania, USA
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  • FRANCIS E. MARCHLINSKI M.D.

    1. Cardiovascular Division, Hospital of The University of Pennsylvania and Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, Pennsylvania, USA
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  • Dr. Dixit is supported by American College of Cardiology Foundation—Proctor Gamble Career Development Award in Cardiac Arrhythmias and The McCabe Pilot Fund Award. This study was supported by an unrestricted grant from Boston Scientific. Drs. Dixit, Marchlinski, and Callans have received speakers' honoraria from Biosense Webster. Dr. Gerstenfeld has received funding from Biosense Webster and Dr. Cooper has received funding from Boston Scientific.

  • Manuscript received 6 April 2006; Revised manuscript received 24 May 2006; Accepted for publication 25 May 2006

Address for correspondence: Sanjay Dixit, M.D., 9 Founders Pavilion, Hospital of the University of Pennsylvania, 3400 Spruce Street, Philadelphia, PA 19104. Fax: 215-615-4350; E-mail: Sanjay.Dixit@uphs.upenn.edu

Abstract

Objective: To compare safety and efficacy of 8-mm versus cooled tip catheter in achieving electrical isolation (EI) of pulmonary veins (PV) for long-term control of atrial fibrillation (AF).

Background: There is paucity of studies comparing safety/efficacy of 8-mm and cooled tip catheters in patients undergoing AF ablation.

Methods and Results: This was a randomized and patient-blinded study. Subjects were followed by clinic visits (at 6 weeks and 6 months) and transtelephonic monitoring (3-week duration) done around each visit. Primary endpoints were: (1) long-term AF control (complete freedom and/or >90% reduction in AF burden on or off antiarrhythmic drugs at 6 months after a single ablation), and (2) occurrence of serious adverse events (cardiac tamponade, stroke, LA-esophageal fistula, and/or death). Eighty-two patients (age 56 ± 9 years, 60 males, paroxysmal AF = 59) were randomized (42 patients to 8-mm tip and 40 patients to cooled tip). EI of PVs was achieved in shorter time by the 8-mm tip as compared with cooled tip catheter (40 ± 23 minutes vs 50 ± 30 minutes; P < 0.05) but long-term AF control was not different between the two (32 patients [78%] vs 28 patients [70%], respectively; P = NS). One serious adverse event occurred in each group (LA-esophageal fistula and stroke, respectively) and no significant PV stenosis was observed in either.

Conclusion: EI of PVs using either 8-mm or cooled tip catheter results in long-term AF control in the majority after a single ablation procedure, with comparable efficacy and safety.

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