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

IF 9.1 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Circulation. Arrhythmia and electrophysiology Pub Date : 2024-02-01 Epub Date: 2024-01-29 DOI:10.1161/CIRCEP.123.012402

Nándor Szegedi, Zoltán Salló, Vivien Klaudia Nagy, István Osztheimer, István Hizoh, Bálint Lakatos, Melinda Boussoussou, Gábor Orbán, Márton Boga, Arnold Béla Ferencz, Ferenc Komlósi, Patrik Tóth, Péter Perge, Attila Kovács, Béla Merkely, László Gellér

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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; P =0.02), left atrial dwell (63 versus 71 minutes; P =0.01), and radiofrequency (303 versus 1040 seconds; P <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; P =0.01). There was no difference in first-pass isolation (83% versus 82%; P =1.0) or acute reconnection (4% versus 14%; P =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 (P =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.

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通过侵入性重映射进行高功率和超高功率短时 PVI 的长期耐久性：HPSD 重映射研究。

背景：高功率短时消融术在肺静脉隔离（PVI）方面的疗效和安全性令人印象深刻；然而，高功率短时消融术的初步疗效却令人沮丧。本研究比较了使用 90 W 和 50 W 功率设置进行肺静脉隔离的长期耐久性：患者按 1:1 随机分配，使用功率设置为 90 W 或 50 W 的 QDOT 导管进行 PVI。对患者进行为期 12 个月的随访，以检测房颤复发情况：我们共纳入了 46 名患者（平均年龄 64 岁；女性占 48%）。手术时间（76 分钟对 84 分钟；P=0.02）、左心房停留时间（63 分钟对 71 分钟；P=0.01）和射频时间（303 秒对 1040 秒；PP=0.01）。90W 和 50W 的首次分离率（83% 对 82%；P=1.0）或急性再连接率（4% 对 14%；P=0.3）没有差异。40 名患者接受了重复电生理学检查。按每个 PV 计算，90W 和 50W 能量设置组分别有 72/78 个 PV（92%）和 68/77 个 PV（88%）出现持久的 PVI；效应大小：72/78-68/77=0.040，95% CI 下限=-0.051（非劣效性下限=-0.1，即符合非劣效性）。无并发症发生。90W组和50W组的12个月无房颤生存率没有差异（P=0.2）：结论：90W 和 50W 的持久 PVI 和无心律失常存活率同样很高。与 50W 相比，90W 的手术时间、左心房停留时间和射频时间更短。由于样本量太小，无法对高功率和超高功率短时 PVI 的安全性和长期疗效做出结论；需要进一步的研究来解决这一问题：URL：https://www.clinicaltrials.gov；唯一标识符：NCT05459831。

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来源期刊

Circulation. Arrhythmia and electrophysiology 医学-心血管系统

CiteScore

13.70

自引率

4.80%

发文量

187

审稿时长

4-8 weeks

期刊介绍： Circulation: Arrhythmia and Electrophysiology is a journal dedicated to the study and application of clinical cardiac electrophysiology. It covers a wide range of topics including the diagnosis and treatment of cardiac arrhythmias, as well as research in this field. The journal accepts various types of studies, including observational research, clinical trials, epidemiological studies, and advancements in translational research.