INTRODUCTION: Single-shot devices have been developed to simplify pulmonary vein isolation (PVI). Randomized studies of the second-generation cryoballoon (CB 2nd) demonstrated excellent results. There are limited data comparing results of circular pulmonary vein ablation catheter (PVAC) with conventional RF ablation or CB for PVI. OBJECTIVE: Using a sequential registry cohort and a prospective randomized study, we aimed to compare the acute and long-term results of CB 2nd and PVAC Gold. METHODS: In the registry, consecutive patients with paroxysmal atrial fibrillation (AF) undergoing their first PVI were included. The preferred method used was PVAC Gold in 2014 and CB 2nd in 2015. Subsequently, a randomized study (PVAC vs. CB 2nd) was performed. Ablation success was measured as freedom of AF or atrial tachycardias (AT) off antiarrhythmic drugs. RESULTS: In the registry cohort, PVAC Gold was used in 60 patients and CB 2nd in 56 patients (age 66 ± 11 years, 52% male, LAD 43 ± 6). In the randomized study, 20 patients were treated with PVAC Gold and 22 with CB 2nd (age 67 ± 9; 43% men, LAD 40 ± 7 mm). During a mean follow up of 13.2 ± 3.6 months, success was 54% in PVAC Gold patients and 81% in CB 2nd cases (p = 0.001). In the randomized study 12 months success was 50% versus 86%, p < 0.05. Complications occurred rare in both groups. CONCLUSIONS: Our registry data and the randomized study both suggest superiority of PVI using CB 2nd as compared with PVI using PVAC Gold.
RCT Entities:
INTRODUCTION: Single-shot devices have been developed to simplify pulmonary vein isolation (PVI). Randomized studies of the second-generation cryoballoon (CB 2nd) demonstrated excellent results. There are limited data comparing results of circular pulmonary vein ablation catheter (PVAC) with conventional RF ablation or CB for PVI. OBJECTIVE: Using a sequential registry cohort and a prospective randomized study, we aimed to compare the acute and long-term results of CB 2nd and PVAC Gold. METHODS: In the registry, consecutive patients with paroxysmal atrial fibrillation (AF) undergoing their first PVI were included. The preferred method used was PVAC Gold in 2014 and CB 2nd in 2015. Subsequently, a randomized study (PVAC vs. CB 2nd) was performed. Ablation success was measured as freedom of AF or atrial tachycardias (AT) off antiarrhythmic drugs. RESULTS: In the registry cohort, PVAC Gold was used in 60 patients and CB 2nd in 56 patients (age 66 ± 11 years, 52% male, LAD 43 ± 6). In the randomized study, 20 patients were treated with PVAC Gold and 22 with CB 2nd (age 67 ± 9; 43% men, LAD 40 ± 7 mm). During a mean follow up of 13.2 ± 3.6 months, success was 54% in PVAC Goldpatients and 81% in CB 2nd cases (p = 0.001). In the randomized study 12 months success was 50% versus 86%, p < 0.05. Complications occurred rare in both groups. CONCLUSIONS: Our registry data and the randomized study both suggest superiority of PVI using CB 2nd as compared with PVI using PVAC Gold.
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