高功率和超高功率短时间 PVI 的侵入性再映射的长期耐久性：HPSD 再映射研究。

Long-Term Durability of High- and Very High-Power Short-Duration PVI by Invasive Remapping: The HPSD Remap Study.

机构信息

Cardiology Department, Heart and Vascular Center, Semmelweis University, Budapest, Hungary.

出版信息

Circ Arrhythm Electrophysiol. 2024 Feb;17(2):e012402. doi: 10.1161/CIRCEP.123.012402. Epub 2024 Jan 29.

DOI:10.1161/CIRCEP.123.012402

PMID:38284286

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10876176/

Abstract

BACKGROUND

High-power short-duration ablation has shown impressive efficacy and safety for pulmonary vein isolation (PVI); however, initial efficacy results with very high power short-duration ablation were discouraging. This study compared the long-term durability of PVI performed with a 90- versus 50-W power setting.

METHODS

Patients were randomized 1:1 to undergo PVI with the QDOT catheter using a power setting of 90 or 50 W. Three months after the index procedure, patients underwent a repeat electrophysiology study to identify pulmonary vein reconnections. Patients were followed for 12 months to detect AF recurrences.

RESULTS

We included 46 patients (mean age, 64 years; women, 48%). Procedure (76 versus 84 minutes; =0.02), left atrial dwell (63 versus 71 minutes; =0.01), and radiofrequency (303 versus 1040 seconds; <0.0001) times were shorter with 90- versus 50-W procedures, while the number of radiofrequency applications was higher with 90 versus 50 W (77 versus 67; =0.01). There was no difference in first-pass isolation (83% versus 82%; =1.0) or acute reconnection (4% versus 14%; =0.3) rates between 90 and 50 W. Forty patients underwent a repeat electrophysiology study. Durable PVI on a per PV basis was present in 72/78 (92%) versus 68/77 (88%) PVs in the 90- and 50-W energy setting groups, respectively; effect size: 72/78-68/77=0.040, lower 95% CI=-0.051 (noninferiority limit=-0.1, ie, noninferiority is met). No complications occurred. There was no difference in 12-month atrial fibrillation-free survival between the 90- and 50-W groups ( =0.2).

CONCLUSIONS

Similarly high rates of durable PVI and arrhythmia-free survival were achieved with 90 and 50 W. Procedure, left atrial dwell, and radiofrequency times were shorter with 90 W compared with 50 W. The sample size is too small to conclude the safety and long-term efficacy of the high and very high-power short-duration PVI; further studies are needed to address this topic.

REGISTRATION

URL: https://www.clinicaltrials.gov; Unique identifier: NCT05459831.

摘要

背景

高功率短时间消融在肺静脉隔离（PVI）中显示出令人印象深刻的疗效和安全性；然而，最初使用非常高功率短时间消融的初始疗效结果令人沮丧。本研究比较了使用 90 与 50W 功率设置进行的 PVI 的长期耐久性。

方法

将患者以 1:1 的比例随机分为两组，分别使用 QDOT 导管进行 PVI，功率设置为 90 或 50W。指数手术后 3 个月，患者行重复电生理研究以确定肺静脉再连接。患者随访 12 个月以检测 AF 复发。

结果

我们纳入了 46 名患者（平均年龄 64 岁；女性 48%）。90W 组的手术（76 分钟对 84 分钟； =0.02）、左心房停留（63 分钟对 71 分钟； =0.01）和射频（303 秒对 1040 秒； <0.0001）时间更短，而 90W 组的射频应用次数更高（77 次对 67 次； =0.01）。90W 和 50W 组的首次通过隔离（83%对 82%； =1.0）或急性再连接（4%对 14%； =0.3）率无差异。40 名患者行重复电生理研究。90W 和 50W 能量设置组分别有 72/78（92%）和 68/77（88%）个肺静脉存在持久的 PVI；效应量：72/78-68/77=0.040，较低的 95%CI=-0.051（非劣效性下限=-0.1，即符合非劣效性）。无并发症发生。90W 和 50W 组 12 个月无房颤生存无差异（ =0.2）。