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EXPERIMENTAL STUDY

A new radiofrequency thermal balloon catheter for pulmonary vein isolation

^a Heart Center, Shonan Kamakura General Hospital, Kamakura and the Division of Pathology, Tokyo Metropolitan Hiro-o General Hospital, Tokyo, Japan

Manuscript received March 22, 2001; revised manuscript received August 13, 2001, accepted August 28, 2001.

^* Reprint requests and correspondence: Dr. Shutaro Satake, Heart Center, Shonan Kamakura General Hospital, 1202-1 Yamazaki, Kamakura-shi Kanagawa, 247-8533, Japan.
satake{at}kamakuraheart.org

OBJECTIVES: We sought to evaluate whether porcine pulmonary vein (PV) isolation (PVI) can be produced by ablation using our novel radiofrequency (RF) thermal balloon catheter (RBC).

BACKGROUND: It has been proposed that PVI can prevent focal atrial fibrillation (AF) originating in or close to the PV.

METHODS: The RBC is composed of a 12F main shaft, a 4F inner tube and a balloon. Inside the balloon, there is a unipolar coil electrode with a thermocouple sensor mounted along the tube, the former to deliver RF energy (13.56 MHz) and the latter to monitor the temperature. After the presence of a PV potential was confirmed, the RBC was safely inserted into the left atrium (LA) by the trans-septal approach. Once the balloon was inflated and optimally wedged at the junction between the PV and LA, RF energy was applied for 5 min. Radiofrequency catheter ablation (RFA) was repeated up to three times, until elimination of the PV potential or dissociation between the LA and PV was observed. Finally, each heart was examined histologically.

RESULTS: In 18 PVs that had PV potentials, PVI was performed, resulting in success in 15 (success rate 83%, 95% confidence interval [CI] 58.0% to 96.3%; failure rate 17%, 95% CI 3.7% to 42.0%). After successful PVI, the PV potentials completely disappeared and the histologic examination revealed circumferential, transmural necrosis around the PV trunks. No major complications, such as PV stenosis or macroscopic thrombosis, were observed.

CONCLUSIONS: The RBC was useful for PVI.

Abbreviations and Acronyms   AF   atrial fibrillation   CI   confidence interval   CSd   coronary sinus distal   ECG   electrocardiogram or electrocardiographic   LAO   left atrium or atrial ostium   PV   pulmonary vein   PVI   pulmonary vein isolation   RBC   radiofrequency (thermal) balloon catheter   RF   radiofrequency   RFA   radiofrequency (catheter) ablation

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