Assaf Amira, Bhagwandien Rohit E, Szili-Torok Tamas, Yap Sing-Chien
Department of Cardiology, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands.
Int J Cardiol Heart Vasc. 2022 Sep 5;42:101115. doi: 10.1016/j.ijcha.2022.101115. eCollection 2022 Oct.
Initial experience suggests that the POLARx cryoballoon system (Boston Scientific) has a similar procedural efficacy and safety as Arctic Front Advance Pro (AFA-Pro, Medtronic). We performed an updated systematic review and meta-analysis comparing POLARx and AFA-Pro. Embase, MEDLINE, Web of Science, Cochrane, and Google Scholar databases were searched until 12/01/2022 for studies comparing POLARx versus AFA-Pro in patients undergoing pulmonary vein (PV) isolation for AF. A total of 8 studies, involving 1146 patients from 11 European centers were included (POLARx n = 317; AFA-Pro n = 819). There were no differences in acute PV isolation, procedure time, fluoroscopy time, ablation time, minimal esophageal temperature, and risk of phrenic nerve palsy or thromboembolic events. Balloon nadir temperatures were lower for POLARx in all PVs. Compared with AFA-Pro, POLARx had a higher rate of first freeze isolation in the left inferior PV (LIPV) (odds ratio [OR]: 2.60; 95 % confidence interval [CI]: 1.06 to 6.43; P = 0.04), higher likelihood of time-to-isolation (TTI) recording in LIPV (OR: 2.91; 95 % CI: 1.54 to 5.49; P = 0.001) and right inferior PV (OR: 3.23; 95 % CI: 1.35 to 7.74; P = 0.008). In contrast, the TTI in LIPV was longer with POLARx in comparison to AFA-Pro (mean difference: 7.61 ; 95 % CI 2.43 to 12.8 ; P = 0.004). In conclusion, POLARx and AFA-Pro have a similar acute outcome. Interestingly, there was a higher rate of TTI recording in the inferior PVs with POLARx. This updated -analysis provides new safety data on esophageal temperature and thromboembolic events.
初步经验表明，POLARx冷冻球囊系统（波士顿科学公司）在手术效果和安全性方面与北极锋进阶版（AFA-Pro，美敦力公司）相似。我们进行了一项更新的系统评价和荟萃分析，比较POLARx和AFA-Pro。检索了Embase、MEDLINE、Web of Science、Cochrane和谷歌学术数据库，直至2022年1月12日，以查找比较POLARx与AFA-Pro在接受房颤肺静脉（PV）隔离患者中的研究。共纳入8项研究，涉及来自11个欧洲中心的1146例患者（POLARx组n = 317；AFA-Pro组n = 819）。在急性PV隔离、手术时间、透视时间、消融时间、最低食管温度以及膈神经麻痹或血栓栓塞事件风险方面无差异。所有PV中，POLARx的球囊最低点温度较低。与AFA-Pro相比，POLARx在左下肺静脉（LIPV）的首次冷冻隔离率更高（优势比[OR]：2.60；95%置信区间[CI]：1.06至6.43；P = 0.04），在LIPV记录隔离时间（TTI）的可能性更高（OR：2.91；95%CI：1.54至5.49；P = 0.001），在右下肺静脉也是如此（OR：3.23；95%CI：1.35至7.74；P = 0.008）。相比之下，与AFA-Pro相比，POLARx在LIPV的TTI更长（平均差值：7.61；95%CI 2.43至12.8；P = 0.004）。总之，POLARx和AFA-Pro的急性结局相似。有趣的是，POLARx在肺下静脉记录TTI的比率更高。这项更新的分析提供了关于食管温度和血栓栓塞事件的新安全数据。
