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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
Author(s) -
DIXIT SANJAY,
GERSTENFELD EDWARD P.,
CALLANS DAVID J.,
COOPER JOSHUA M.,
LIN DAVID,
RUSSO ANDREA M.,
VERDINO RALPH J.,
PATEL VICKAS V.,
KIMMEL STEPHEN E.,
RATCLIFFE SARAH J.,
HSIA HENRY H.,
NAYAK HEMAL M.,
ZADO ERICA,
REN JIANFANG,
MARCHLINSKI FRANCIS E.
Publication year - 2006
Publication title -
journal of cardiovascular electrophysiology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.193
H-Index - 138
eISSN - 1540-8167
pISSN - 1045-3873
DOI - 10.1111/j.1540-8167.2006.00558.x
Subject(s) - medicine , atrial fibrillation , catheter ablation , catheter , ablation , randomized controlled trial , cardiology , adverse effect , stroke (engine) , cardiac tamponade , tamponade , stenosis , surgery , anesthesia , mechanical engineering , engineering
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.