Department of Rhythmology, University Heart Center Lübeck, University Hospital Schleswig-Holstein, Ratzeburger Allee 160, D-23538 Lübeck, Germany.
Asklepios Klinik St. Georg, Hamburg, Germany.
Europace. 2023 Feb 16;25(2):374-381. doi: 10.1093/europace/euac212.
Cryoballoon (CB)-based pulmonary vein isolation (PVI) is an effective treatment for atrial fibrillation (AF). The most frequent complication during CB-based PVI is right-sided phrenic nerve injury (PNI) which is leading to premature abortion of the freeze cycle. Here, we analysed reconnection rates after CB-based PVI and PNI in a large-scale population during repeat procedures.
In the YETI registry, a total of 17 356 patients underwent CB-based PVI in 33 centres, and 731 (4.2%) patients experienced PNI. A total of 111/731 (15.2%) patients received a repeat procedure for treatment of recurrent AF. In 94/111 (84.7%) patients data on repeat procedures were available. A total of 89/94 (94.7%) index pulmonary veins (PVs) have been isolated during the initial PVI. During repeat procedures, 22 (24.7%) of initially isolated index PVs showed reconnection. The use of a double stop technique did non influence the PV reconnection rate (P = 0.464). The time to PNI was 140.5 ± 45.1 s in patients with persistent PVI and 133.5 ± 53.8 s in patients with reconnection (P = 0.559). No differences were noted between the two populations in terms of CB temperature at the time of PNI (P = 0.362). The only parameter associated with isolation durability was CB temperature after 30 s of freezing. The PV reconnection did not influence the time to AF recurrence.
In patients with cryoballon application abortion due to PNI, a high rate of persistent PVI rate was found at repeat procedures. Our data may help to identify the optimal dosing protocol in CB-based PVI procedures.
https://clinicaltrials.gov/ct2/show/NCT03645577?term=YETI&cntry=DE&draw=2&rank=1 ClinicalTrials.gov Identifier: NCT03645577.
基于冷冻球囊的肺静脉隔离（PVI）是治疗心房颤动（AF）的有效方法。基于冷冻球囊的 PVI 过程中最常见的并发症是右侧膈神经损伤（PNI），这会导致冷冻周期提前终止。在此，我们分析了在大规模人群中，重复消融程序时基于冷冻球囊的 PVI 和 PNI 后的再连接率。
在 YETI 注册研究中，共有 17356 例患者在 33 个中心接受了基于冷冻球囊的 PVI，731 例（4.2%）患者发生了 PNI。共有 111/731 例（15.2%）患者因复发性 AF 接受了重复消融程序。在 111 例患者中有 94 例（84.7%）重复消融程序的数据可用。在初始 PVI 中，共有 89/94 例（94.7%）的索引肺静脉（PV）被隔离。在重复消融程序中，最初隔离的 89 个索引 PV 中有 22 个（24.7%）显示再连接。使用双阻断技术并不影响 PV 再连接率（P = 0.464）。在持续 PVI 的患者中，PNI 时间为 140.5 ± 45.1 s，在再连接患者中为 133.5 ± 53.8 s（P = 0.559）。在 PNI 时的冷冻球囊温度方面，两个人群之间没有差异（P = 0.362）。与隔离持久性相关的唯一参数是冷冻后 30 s 的冷冻球囊温度。PV 再连接并不影响 AF 复发的时间。
在因 PNI 导致冷冻球囊应用中止的患者中，重复消融程序时发现持续 PVI 率较高。我们的数据可能有助于确定基于冷冻球囊的 PVI 程序中的最佳剂量方案。
https://clinicaltrials.gov/ct2/show/NCT03645577?term=YETI&cntry=DE&draw=2&rank=1 临床试验标识符：NCT03645577。
