Randomized comparison between open irrigation technology and intracardiac-echo-guided energy delivery for pulmonary vein antrum isolation: procedural parameters, outcomes, and the effect on esophageal injury.

INTRODUCTION: We performed a prospective study to compare efficacy and safety of both open irrigation tip (OIT) technology with intracardiac echo (ICE)-guided energy delivery in patients presenting for PVAI. METHODS AND
RESULTS: Fifty-three patients presenting for PVAI were randomized to ablation using an OIT catheter (Group 1, 26 patients; temperature and power were set at 50 degrees and 50 W, respectively, with a saline pump flow rate of 30 mL/min) or radiofrequency (RF) energy delivery under ICE guidance (Group 2, 27 patients; energy was titrated based on microbubbles formation). The mean procedure time and fluoroscopy exposure were lower in Group 1 (164 +/- 42 min and 7,560 +/- 2,298 microGray m2 vs 204 +/- 47 min and 12,240 +/- 4,356 microGray m2; P = 0.005 and 0.008, respectively). Moreover, the durations of RF lesions applied per PV antrum was lower in Group 1 compared with Group 2 (5.1 +/- 2.2 min vs 9.2 +/- 3.2 min, P = 0.03, respectively). Within 24 hours after PVAI in 35.7% (all erythema) of Group 1 and 57.1% (21.4% erythema and 35.7% necrosis) of Group 2, patients' esophageal wall changes were documented. After 14 +/- 2 months of follow up, recurrences were documented in 19.2% of Group 1 and 22.2% of Group 2 patients.
CONCLUSION: Although both OIT and ICE-guided energy delivery possess a similar effect in treating AF, OIT seems to be superior in terms of achieving isolation and shortening fluoroscopy exposure. Moreover, a lower incidence of esophageal wall injury was observed utilizing OIT for PVAI.

RCT Entities:   Population Interventions Outcomes