INTRODUCTION: Aim of this study was to compare efficacy and safety of the new ThermoCool Surround Flow® catheter (SFc) versus the ThermoCool® (TCc) in achieving persistent circumferential electrical isolation of the pulmonary veins (PVs) in patients with paroxysmal atrial fibrillation (AF). METHODS AND RESULTS: This multicenter, randomized, controlled study enrolled patients suffering from paroxysmal AF. Randomization was run in a one-to-one fashion between radiofrequency ablation by TCc or SFc. Aim of PVs ablation was documentation of electrical isolation with exit/entrance block recorded on a circular catheter. Among the 106 enrolled patients, 52 (49.0%) were randomized to TCc and 54 (51.0%) to SFc. Total volume of infused saline solution during the procedure was lower in the SFc than in TCc group (752.7 ± 268.6 mL vs 1,165.9 ± 436.2 mL, P < 0.0001). Number of identified and isolated PVs was similar in the 2 groups. Number of PVs remaining isolated 30 minutes after ablation was higher in the SFc than in TCc group (95.2% vs 90.5%, P < 0.03), mainly driven by acute ablation result in the left PVs (96.1% vs 89.7%, P < 0.04). Complications were seldom and observed only in the TCc group (0% vs 3.84%, P < 0.03). At 6-month follow-up SFc patients reported a trend toward less AF recurrences compared to those in the TCc group (22.9% vs 27.0%, P = 0.69). CONCLUSION: PV isolation by SFc lowered the rate of left PV early reconnections and reduced the volume of infused saline solution while maintaining the safety profile of AF ablation.
RCT Entities:
INTRODUCTION: Aim of this study was to compare efficacy and safety of the new ThermoCool Surround Flow® catheter (SFc) versus the ThermoCool® (TCc) in achieving persistent circumferential electrical isolation of the pulmonary veins (PVs) in patients with paroxysmal atrial fibrillation (AF). METHODS AND RESULTS: This multicenter, randomized, controlled study enrolled patients suffering from paroxysmal AF. Randomization was run in a one-to-one fashion between radiofrequency ablation by TCc or SFc. Aim of PVs ablation was documentation of electrical isolation with exit/entrance block recorded on a circular catheter. Among the 106 enrolled patients, 52 (49.0%) were randomized to TCc and 54 (51.0%) to SFc. Total volume of infused saline solution during the procedure was lower in the SFc than in TCc group (752.7 ± 268.6 mL vs 1,165.9 ± 436.2 mL, P < 0.0001). Number of identified and isolated PVs was similar in the 2 groups. Number of PVs remaining isolated 30 minutes after ablation was higher in the SFc than in TCc group (95.2% vs 90.5%, P < 0.03), mainly driven by acute ablation result in the left PVs (96.1% vs 89.7%, P < 0.04). Complications were seldom and observed only in the TCc group (0% vs 3.84%, P < 0.03). At 6-month follow-up SFc patients reported a trend toward less AF recurrences compared to those in the TCc group (22.9% vs 27.0%, P = 0.69). CONCLUSION: PV isolation by SFc lowered the rate of left PV early reconnections and reduced the volume of infused saline solution while maintaining the safety profile of AF ablation.
Authors: Giuseppe Stabile; Antonio De Simone; Francesco Solimene; Assunta Iuliano; Vincenzo La Rocca; Vincenzo Schillaci; Alfonso Panella; Gergana Shopova; Felice Nappi; Francesco Urraro; Giovanni Russo; Giovanni Napolitano; Paola Chiariello Journal: J Atr Fibrillation Date: 2015-04-30
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Authors: Saumil R Oza; Tina D Hunter; Angelo B Biviano; Gopi Dandamudi; Bengt Herweg; Anshul M Patel; Scott J Pollak; Huijian Wang; Robert S Fishel Journal: J Cardiovasc Electrophysiol Date: 2014-04-09
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