Why the study?
Safety concerns have been raised regarding surround flow ablation catheters (STSF), prompting a comparison of the safety and effectiveness of AF ablation using AI versus the CLOSE protocol with STSF.
Does the CLOSE protocol improve 12-month freedom from atrial fibrillation or atrial tachycardia compared to ablation index alone in patients undergoing pulmonary vein isolation?
Does the CLOSE protocol improve 12-month freedom from atrial fibrillation or atrial tachycardia compared to ablation index alone in patients undergoing pulmonary vein isolation?
The CLOSE protocol is more effective than using ablation index alone for achieving 12-month freedom from arrhythmia in patients undergoing pulmonary vein isolation for atrial fibrillation.
Should not yet change PVI protocols; leaves open CLOSE superiority over AI pending randomized confirmation.
AIMS: Pulmonary vein isolation (PVI) using ablation index (AI) incorporates stability, contact force (CF), time, and power. The CLOSE protocol combines AI and ≤6 mm interlesion distance. Safety concerns are raised about surround flow ablation catheters (STSF). To compare safety and effectiveness of an atrial fibrillation (AF) ablation strategy using AI vs. CLOSE protocol using STSF. METHODS AND RESULTS: First cluster was treated using AI and second cluster using CLOSE. Procedural data, safety, and recurrence of any atrial tachycardia (AT) or AF >30 s were collected prospectively. All Classes 1c and III anti-arrhythmic drugs (AAD) were stopped after the blanking period. In total, all 215 consecutive patients [AI: 121 (paroxysmal: n = 97), CLOSE: n = 94 (paroxysmal: n = 74)] were included. Pulmonary vein isolation was reached in all in similar procedure duration (CLOSE: 107 ± 25 vs. AI: 102 ± 24 min; P = 0.1) and similar radiofrequency time (CLOSE: 36 ± 11 vs. AI: 37 ± 8 min; P = 0.4) but first pass isolation was higher in CLOSE vs. AI [left veins: 90% vs. 80%; P < 0.05 and right veins: 84% vs. 73%; P < 0.05]. Twelve-month off-AAD freedom of AF/AT was higher in CLOSE vs. AI [79% (paroxysmal: 85%) vs. 64% (paroxysmal: 68%); P < 0.05]. Only four patients (2%) without recurrence were on AAD during follow-up. Major complications were similar (CLOSE: 2.1% vs. AI: 2.5%; P = 0.87). CONCLUSION: The CLOSE protocol is more effective than a PVI approach solely using AI, especially in paroxysmal AF. In this off-AAD study, 79% of patients were free from AF/AT during 12-month follow-up. The STSF catheter appears to be safe using conventional CLOSE targets.
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Berte et al. (2019) studied this question.
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