Dual-chamber leadless pacemaker implant procedural outcomes: Insights from the AVEIR DR i2i study

IF 5.7 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Heart rhythm Pub Date : 2025-09-01 Epub Date: 2025-03-13 DOI:10.1016/j.hrthm.2025.03.1941

Rahul N. Doshi MD, FACC, FHRS , James E. Ip MD, FHRS , Pascal Defaye MD , Vivek Y. Reddy MD , Derek V. Exner MD, MPH, FHRS , Robert Canby MD, FHRS , Morio Shoda MD, PhD , Maria Grazia Bongiorni MD , Gerhard Hindricks MD , Petr Neuzil MD, PhD , Thomas Callahan MD, FHRS , Sri Sundaram MD, FHRS , Daniel F. Booth MEng , Louis-Philippe Richer PhD , Nima Badie PhD , Reinoud E. Knops MD, PhD

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Abstract

Background

Initial results were recently reported for the AVEIR DR i2i study, which involved the percutaneous implantation of a novel dual-chamber leadless pacemaker (LP) system, with right atrial and right ventricular LPs delivering atrioventricular synchronous pacing.

Objective

The purpose of this study was to evaluate procedural outcomes and learning curve for de novo implantation of the dual-chamber LP (AVEIR DR, Abbott, Abbott Park, IL).

Methods

Implant procedure metrics collected during the study were analyzed, including procedural complications within 30 days of implantation. Procedural outcomes were evaluated according to implanter experience: 1–4 vs 9+ dual-chamber LP implant procedures (ie, initial vs advanced implant experience).

Results

De novo dual-chamber LPs were successfully implanted in 446 of 452 patients (99%) by 126 physicians. Mean procedural duration metrics included 90±37 minutes of introducer sheath insertion-to-removal time, 74±32 minutes of dual-chamber procedure duration, 26±17 minutes of right ventricular LP procedure duration, 42±24 minutes of right atrial LP procedure duration, and 20±13 minutes of fluoroscopy duration; between initial and advanced implant experience, there were reductions of 19%–36% (P<.05) in these duration metrics. There were 62 procedural complications in 50 of 452 patients (11.1%) (ie, 88.9% complication free), predominantly involving cardiac arrhythmias (ie, atrial fibrillation/flutter or complete atrioventricular block; 16 of 452 [3.5%]). Freedom from complications significantly improved from 89% to 98% of patients (P<.05) when comparing initial and advanced implant experience.

Conclusion

In a pivotal investigational study, implantation of a dual-chamber LP system was successful in 99% of patients. Advanced implant experience was accompanied by improvements in procedural outcomes including reduced procedural times (introducer sheath insertion to removal, dual-chamber procedure, ventricular LP and atrial LP procedures, and fluoroscopy) and improved freedom from complications.

Trial Registration

ClinicalTrials.gov identifier: NCT05252702

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双腔无铅起搏器植入手术结果：来自AVEIR DR i2i研究的见解

背景：最近报道了AVEIR DR i2i研究的初步结果，该研究涉及经皮植入一种新型双室无铅起搏器（LP）系统，右房（RA）和右室（RV） LPs提供房室同步起搏。目的：评估双腔LP （AVEIR DR™，雅培）重新植入的手术效果和学习曲线。方法：对研究期间收集的种植过程指标进行分析，包括种植后30天内的手术并发症。根据种植经验评估手术结果：1-4 vs. 9+双腔LP种植手术（即初始与高级种植经验）。结果：126例患者中有446例（98.7%）成功植入双腔LPs。平均手术时间指标包括引入器鞘插入至取出时间（90±37分钟）、双腔手术时间（74±32分钟）、RV LP手术时间（26±17分钟）、RA LP手术时间（42±24分钟）和透视时间（20±13分钟）；在初始和高级植入经验之间，减少了19-36% (p结论：在一项关键的研究中，98.7%的患者成功植入了双腔LP系统。先进的种植经验伴随着手术结果的改善，包括手术时间的减少（引入器鞘插入到取出，双腔手术，VLP和ALP手术，以及透视）和并发症的改善。

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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.