One-year clinical success of a ‘no-bonus’ freeze protocol using the second-generation 28 mm cryoballoon for pulmonary vein isolation

Male Equipment Design Middle Aged Cryosurgery 3. Good health Equipment Failure Analysis 03 medical and health sciences Treatment Outcome 0302 clinical medicine Heart Conduction System Pulmonary Veins Atrial Fibrillation Catheter Ablation Humans Female Longitudinal Studies
DOI: 10.1093/europace/euv024 Publication Date: 2015-04-14T00:21:35Z
ABSTRACT
Studies on the use of the second-generation 28 mm cryoballoon (CB) for the treatment of atrial fibrillation (AF) have reported superior 1-year clinical outcome. Customarily, a bonus freeze cycle is applied after pulmonary vein isolation (PVI). The purpose of the present study was to assess the 1-year clinical outcome following PVI foregoing a bonus freeze cycle.Patients with drug-refractory paroxysmal AF (PAF) or persistent AF underwent PVI using the second-generation 28 mm CB. The freeze cycle duration was set at 240 s. No bonus freeze cycle was applied. Clinical follow-up (FU) included 12-lead ECGs and 24h-Holter ECGs at 3, 6, and 12 months. A total of 45 patients (age 60 ± 11 years, mean LA diameter 42.1 ± 8.6 mm, n = 38 [84%] PAF) underwent CB-based PVI. Of 177 pulmonary veins (PVs) identified, 176/177 (99%) PVs were successfully isolated. The mean number of CB applications was 1.2 ± 0.4, 1.5 ± 0.8, 1.4 ± 0.7, 1.1 ± 0.3 and 1.7 ± 1.2 for the right superior PVs, right inferior PVs, left superior PVs, left inferior PVs, and left common PVs, respectively. Mean procedure and fluoroscopy times were 113 ± 32 and 19 ± 7 min, respectively. Phrenic nerve palsy occurred in 1/45 (2%) patients. One of 45 (2%) patients was lost to FU. After a mean FU period of 392 ± 58 (267-522) days including a 3-month blanking period, 36 of 44 (82%) patients remained in stable sinus rhythm. Five out of eight patients with arrhythmia recurrence underwent a second procedure. Only those PVs isolated with a single freeze cycle (5/11 PVs, 45%) demonstrated PV reconduction. In contrast, no PV reconnection was found in PVs initially treated with multiple freeze cycles.A 'no-bonus'-freeze protocol for PVI using the second-generation 28 mm CB resulted in an 82% 1-year clinical success rate. A bonus freeze cycle following successful PVI may not be essential to superior clinical outcome.
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