Temperature-Controlled Radiofrequency Ablation for Pulmonary Vein Isolation in Patients With Atrial Fibrillation

被引:78
作者
Iwasawa, Jin [1 ]
Koruth, Jacob S. [1 ]
Petru, Jan [2 ]
Dujka, Libor [2 ]
Kralovec, Stepan [2 ]
Mzourkova, Katerina [2 ]
Dukkipati, Srinivas R. [1 ]
Neuzil, Petr [2 ]
Reddy, Vivek Y. [1 ,2 ]
机构
[1] Mt Sinai Med Ctr, Helmsley Electrophysiol Ctr, New York, NY 10029 USA
[2] Na Homolce Hosp, Prague, Czech Republic
关键词
catheter ablation; electrogram; first-in-human; histology; remapping; BALLOON CATHETER ABLATION; FORCE; FEASIBILITY; MULTICENTER; TRIAL;
D O I
10.1016/j.jacc.2017.06.008
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
BACKGROUND Saline irrigation improved the safety of radiofrequency (RF) ablation, but the thermal feedback for energy titration is absent. OBJECTIVES To allow temperature-controlled irrigated ablation, a novel irrigated RF catheter was designed with a diamond-embedded tip (for rapid cooling) and 6 surface thermocouples to reflect tissue temperature. High-resolution electrograms (EGMs) from the split-tip electrode allowed rapid lesion assessment. The authors evaluated the preclinical and clinical performance of this catheter for pulmonary vein (PV) isolation. METHODS Using the DiamondTemp (DT) catheter, pigs (n = 6) underwent discrete atrial ablation in a temperature control mode (60 degrees C/50 W) until there was similar to 80% EGM amplitude reduction. In a single-center clinical feasibility study, 35 patients underwent PV isolation with the DT catheter (study group); patients were planned for PV remapping after 3 months, regardless of symptomatology. A control group included 35 patients who underwent PV isolation with a standard force-sensing catheter. RESULTS Porcine lesion histology revealed transmurality in 51 of 55 lesions (92.7%). In patients, all PVs were successfully isolated; no char or thrombus formation was observed. Compared with the control group, the study cohort had shorter mean RF application duration (26.3 +/- 5.2 min vs. 89.2 +/- 27.2 min; p < 0.001), shorter mean fluoroscopic time (11.2 +/- 8.5 min vs. 19.5 +/- 6.8 min; p < 0.001), and lower acute dormant PV reconduction (0 of 35 vs. 5 of 35; p = 0.024). At 3 months, 23 patients underwent remapping: 39 of 46 PV pairs (84.8%) remained durably isolated in 17 of these patients (73.9%). CONCLUSIONS This first-in-human series demonstrated that temperature-controlled irrigated ablation produced rapid, efficient, and durable PV isolation. (C) 2017 by the American College of Cardiology Foundation.
引用
收藏
页码:542 / 553
页数:12
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