Operator learning curve with a novel dual-energy lattice-tip ablation system

IF 5.7 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Heart rhythm Pub Date : 2026-01-01 DOI:10.1016/j.hrthm.2025.02.006

Erich L. Kiehl MD , Stavros E. Mountantonakis MD , Moussa C. Mansour MD, FHRS , Devi G. Nair MD, FHRS , Dinesh Sharma MD, FHRS , Tyler L. Taigen MD , Petr Neuzil MD , Josef Kautzner MD , Jose Osorio MD, FHRS , Andrea Natale MD, FHRS , John D. Hummel MD, FHRS , Anish K. Amin MD, FHRS , Usman R. Siddiqui MD, FHRS , Alan Bulava MD , Shephal K. Doshi MD , Chinmay P. Patel MD , Yisachar J. Greenberg MD , Roderick H. Tung MD, FHRS , Doron Harlev MD, MBA , Paul Hultz MSc , Elad Anter MD

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引用次数: 0

Abstract

Background

The SPHERE Per-AF trial demonstrated noninferiority for a primary composite effectiveness endpoint in patients with persistent atrial fibrillation (AF) treated with a 9-mm, lattice-tip, pulsed field (PF)/radiofrequency (RF) system (74%) vs conventional contact force-sensing RF (65%). Although operators were highly experienced with the control, the vast majority was new to the investigational system.

Objective

The aim of this study was to assess the learning curve using this novel system.

Methods

Patients were grouped based on the sequential procedures performed per operator. Operators who performed ≤2 investigational procedures were excluded. The composite effectiveness endpoint was freedom from acute procedural failure, repeat ablation at any time, recurrence of arrhythmia, drug initiation/escalation, or cardioversion each at 1 year excluding a 3-month blanking period. Efficiency endpoints included “skin-to-skin” procedure time.

Results

The total cohort included 443 patients (235 investigational [31 roll-in], 208 control). Primary effectiveness in the investigational cohort improved significantly with increased procedural order. Efficacy was 65% (74 of 114) for the first 5 patients per operator, 75% (33 of 44) for patients 6 to 10, and 80% (60 of 75) for patients >10. Kaplan-Meier effectiveness estimates at 1-year follow-up were significantly higher in the investigational cohort after 10 procedures performed, compared with control (80% vs 65%, P < .05). With the investigational system, total procedure time was reduced by 25 minutes (100 vs 125) within the first 5 procedures performed (P < .001).

Conclusion

AF ablation with a novel dual-energy, lattice-tip ablation system resulted in greater clinical efficacy compared with conventional RF after a rapid operator learning curve, with superior procedural efficiency noted from the initial procedures onward.

Clinical Trial Registration

NCT05120193

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一种新型双能点阵尖端烧蚀系统的操作员学习曲线。

背景：SPHERE Per-AF试验表明，与传统接触式力传感射频（65%）相比，使用9毫米点阵尖端脉冲场(PF)/射频（RF）系统治疗的持续性心房颤动（AF）患者的主要复合有效性终点（74%）无劣势。虽然操作员在控制方面经验丰富，但绝大多数是调查系统的新手。目的：评价该系统的学习曲线。方法：根据每位手术人员的手术顺序对患者进行分组。进行了≤2次调查操作的操作人员被排除在外。综合疗效终点为无急性手术失败、任何时间重复消融、心律失常复发、药物起始/升级或除3个月空白期外每一年的心律转复。效率终点包括“皮肤到皮肤”的手术时间。结果：总队列包括443例患者（235例为研究组[31入组]，208例为对照组）。随着程序顺序的增加，研究队列的主要有效性显著提高。每名操作者前5名患者的疗效为65%(74/114)，6-10名患者的疗效为75% (33/44)，bbb10名患者的疗效为80%（60/75）。与对照组相比，研究队列在进行10次手术后，1年随访时的Kaplan-Meier有效性估计显着高于对照组（80% vs 65%）。结论：在快速的操作人员学习曲线后，采用新型双能量、点阵尖端消融系统的房颤消融与传统射频相比具有更高的临床疗效，从初始手术开始就具有卓越的手术效率。

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来源期刊

Heart rhythm 医学-心血管系统

CiteScore

10.50

自引率

5.50%

发文量

1465

审稿时长

24 days

期刊介绍： HeartRhythm, the official Journal of the Heart Rhythm Society and the Cardiac Electrophysiology Society, is a unique journal for fundamental discovery and clinical applicability. HeartRhythm integrates the entire cardiac electrophysiology (EP) community from basic and clinical academic researchers, private practitioners, engineers, allied professionals, industry, and trainees, all of whom are vital and interdependent members of our EP community. The Heart Rhythm Society is the international leader in science, education, and advocacy for cardiac arrhythmia professionals and patients, and the primary information resource on heart rhythm disorders. Its mission is to improve the care of patients by promoting research, education, and optimal health care policies and standards.