Novel vs established cryoballoon ablation system for atrial fibrillation: A systematic review and meta-analysis

IF 2.5 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS

Heart Rhythm O2 Pub Date : 2025-01-01 DOI:10.1016/j.hroo.2024.10.022

Jeanne du Fay de Lavallaz MD, PhD , Sven Knecht MSc , Tobias Reichlin MD , Philipp Krisai MD , Diego Mannhart MD , Teodor Serban MD , Laurent Roten MD , Rebecca Arnet MD , Corinne Isenegger MD , Judith Minder MD , Fabian Jordan MD , Christian Sticherling MD , Michael Kühne MD , Patrick Badertscher MD

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Abstract

Background

Recently, a novel cryoballoon ablation system (POLARx) for the treatment of atrial fibrillation has been introduced.

Objective

We aimed at systematically reviewing the efficacy and safety of the POLARx compared with the ArcticFront system.

Methods

Structured systematic database search for articles published between 2021 and 2024 reporting the efficacy and/or safety of the POLARx system for atrial fibrillation ablation. The co-primary endpoints were the long-term efficacy and safety of the POLARx system.

Results

Of the 24 studies with 5364 patients (weighted mean age 62.4 years) included, 15 compared the POLARx system (1746 patients) with the ArcticFront system (2282 patients). Despite significantly lower temperatures at isolation (POLARx –46.3 °C, ArcticFront –31.6 °C, P < .01) and nadir temperatures (POLARx –56.5 °C, ArcticFront –47.8 °C, P < .01), the POLARx system did not show a better acute (98.9% and 99.2% successfully ablated patients and 99.5% and 99.8% successfully ablated pulmonary veins in the POLARx and ArcticFront groups, respectively) or long-term (after a weighted mean follow-up of 12.6 months, the success rate was 69.5% with POLARx and 60.2% with ArcticFront, P = .98) efficacy. While most complications were similar between the POLARx and ArcticFront groups, the incidence of phrenic nerve palsies in the pooled cohorts (all POLARx vs all ArcticFront control patients) differed (2.7% vs 1.6% in the POLARx vs ArcticFront groups; odds ratio 1.79, 95% confidence interval 1.14–2.83, P = .01).

Conclusion

The novel POLARx system provided similar efficiency and acute/long-term efficacy but showed a higher incidence of phrenic nerve palsies compared with the ArcticFront system.

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背景最近，一种用于治疗心房颤动的新型冷冻球囊消融系统（POLARx）问世。目的我们旨在系统回顾 POLARx 与 ArcticFront 系统相比的疗效和安全性。结果在纳入的 24 项研究的 5364 名患者（加权平均年龄 62.4 岁）中，有 15 项研究将 POLARx 系统（1746 名患者）与 ArcticFront 系统（2282 名患者）进行了比较。尽管隔离温度（POLARx -46.3 °C，ArcticFront -31.6 °C，P < .01）和最低温度（POLARx -56.5 °C，ArcticFront -47.8 °C，P < .01）明显降低，但 POLARx 系统并未显示出更好的急性期（98.9% 和 99.POLARx组和ArcticFront组成功消融患者的比例分别为98.9%和99.2%，成功消融肺静脉的比例分别为99.5%和99.8%）或长期疗效（加权平均随访12.6个月后，POLARx的成功率为69.5%，ArcticFront的成功率为60.2%，P = .98）。虽然 POLARx 组和 ArcticFront 组的大多数并发症相似，但汇总队列（所有 POLARx 对照组和所有 ArcticFront 对照组患者）中膈神经麻痹的发生率不同（POLARx 组和 ArcticFront 组分别为 2.7% 和 1.6%；几率比 1.79，95% 置信区间 1.14）。结论新型 POLARx 系统具有相似的效率和急性/长期疗效，但与 ArcticFront 系统相比，膈神经麻痹的发生率更高。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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