The Barts Heart Centre, St Bartholomew's Hospital, Barts Health NHS trust, W Smithfield, EC1A 7BE London, UK.
William Harvey Research Institute, Queen Mary University of London, London, UK.
Europace. 2023 Nov 2;25(11). doi: 10.1093/europace/euad286.
Pulmonary vein isolation (PVI) is the cornerstone of catheter ablation for atrial fibrillation (AF). There are limited data on the PolarX Cryoballoon. The study aimed to establish the safety, efficacy, and feasibility of same day discharge for Cryoballoon PVI.
Multi-centre study across 12 centres. Procedural metrics, safety profile, and procedural efficacy of the PolarX Cryoballoon with the Arctic Front Advance (AFA) Cryoballoon were compared in a cohort large enough to provide definitive comparative data. A total of 1688 patients underwent PVI with cryoablation (50% PolarX and 50% AFA). Successful PVI was achieved with 1677 (99.3%) patients with 97.2% (n = 1641) performed as day case procedures with a complication rate of <1%. Safety, procedural metrics, and efficacy of the PolarX Cryoballoon were comparable with the AFA cohort. The PolarX Cryoballoon demonstrated a nadir temperature of -54.6 ± 7.6°C, temperature at 30 s of -38.6 ± 7.2°C, time to -40°C of 34.1 ± 13.7 s, and time to isolation of 49.8 ± 33.2 s. Independent predictors for achieving PVI included time to reach -40°C [odds ratio (OR) 1.34; P < 0.001] and nadir temperature (OR 1.24; P < 0.001) with an optimal cut-off of ≤34 s [area under the curve (AUC) 0.73; P < 0.001] and nadir temperature of ≤-54.0°C (AUC 0.71; P < 0.001), respectively.
This large-scale UK multi-centre study has shown that Cryoballoon PVI is a safe, effective day case procedure. PVI using the PolarX Cryoballoon was similarly safe and effective as the AFA Cryoballoon. The cryoablation metrics achieved with the PolarX Cryoballoon were different to that reported with the AFA Cryoballoon. Modified cryoablation targets are required when utilizing the PolarX Cryoballoon.
肺静脉隔离(PVI)是治疗心房颤动(AF)的导管消融的基石。关于 PolarX 冷冻球囊的数据有限。本研究旨在确定同一天出院行冷冻球囊 PVI 的安全性、疗效和可行性。
该研究为多中心研究,共纳入 12 个中心的患者。在足够大的队列中比较 PolarX 冷冻球囊与 Arctic Front Advance(AFA)冷冻球囊的手术指标、安全性和疗效,以提供明确的对比数据。共 1688 例患者接受冷冻球囊消融治疗(50%为 PolarX,50%为 AFA)。1677 例(99.3%)患者成功实施 PVI,其中 97.2%(n=1641)作为日间手术进行,并发症发生率<1%。PolarX 冷冻球囊的安全性、手术指标和疗效与 AFA 组相当。PolarX 冷冻球囊的最低温度为-54.6±7.6°C,30 秒时的温度为-38.6±7.2°C,达到-40°C 的时间为 34.1±13.7s,隔离时间为 49.8±33.2s。实现 PVI 的独立预测因素包括达到-40°C 的时间[比值比(OR)1.34;P<0.001]和最低温度(OR 1.24;P<0.001),最佳截止值为≤34s[曲线下面积(AUC)0.73;P<0.001]和最低温度≤-54.0°C(AUC 0.71;P<0.001)。
这项英国多中心大型研究表明,冷冻球囊 PVI 是一种安全、有效的日间手术。使用 PolarX 冷冻球囊进行 PVI 与使用 AFA 冷冻球囊同样安全有效。与 AFA 冷冻球囊相比,PolarX 冷冻球囊的冷冻消融指标有所不同。使用 PolarX 冷冻球囊时需要调整冷冻消融的目标。