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.
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.


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.


CONCLUSIONS
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.
Dixit
Sanjay
S
Cardiovascular Division, Hospital of The University of Pennsylvania, Philadelphia, Pennsylvania 19104, USA. Sanjay.Dixit@uphs.upenn.edu
Gerstenfeld
Edward P
EP
Callans
David J
DJ
Cooper
Joshua M
JM
Lin
David
D
Russo
Andrea M
AM
Verdino
Ralph J
RJ
Patel
Vickas V
VV
Kimmel
Stephen E
SE
Ratcliffe
Sarah J
SJ
Hsia
Henry H
HH
Nayak
Hemal M
HM
Zado
Erica
E
Ren
Jian-Fang
JF
Marchlinski
Francis E
FE
D001281:Atrial Fibrillation / Q000175:diagnosis* / Q000601:surgery*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D017115:Catheter Ablation / Q000295:instrumentation* / Q000379:methods; D017679:Cryotherapy / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D004867:Equipment Design; D019544:Equipment Failure Analysis; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011667:Pulmonary Veins / Q000601:surgery*; D016037:Single-Blind Method; D016896:Treatment Outcome