Institut Cardiovasculaire de Grenoble, Grenoble, France.
Médipôle Lyon-Villeurbanne, Villeurbanne, France.
EuroIntervention. 2023 Feb 20;18(14):1150-1555. doi: 10.4244/EIJ-D-22-00662.
Transcatheter aortic valve implantation (TAVI) and complex percutaneous coronary interventions (PCI) may require cardiac pacing during device delivery, generally requiring the insertion of a temporary pacing lead via an additional venous access site. The purpose-built Electroducer Sleeve device provides direct wire pacing without the need for a temporary venous pacemaker.
This study assessed the safety of temporary cardiac pacing using the novel sleeve device during PCI.
This was a multicentre, non-randomised, prospective, first-in-human, single-arm, pilot study. The primary endpoint was analysis of a safety outcome, defined as the occurrence of haematomas or bleeding complications at the device vascular access site. Secondary endpoints included analyses of effectiveness and qualitative outcomes.
Sixty patients (mean age: 77.9±9.6 years) from 4 centres in France were included: 39 (65%) underwent TAVI, and 21 (35%) underwent PCI. Procedures were performed using the sleeve with access through the radial (32 patients; 53.3%) or femoral arteries (26; 43.3%), or the femoral vein (2; 3.3%). Primary endpoint analysis revealed that 2 patients (3.3%) developed EArly Discharge After Transradial Stenting of CoronarY Arteries Study (EASY) grade I/Bleeding Academic Research Consortium (BARC) type I haematomas at the device access site. As a measure of effectiveness, a haemodynamic effect was observed after each spike delivery in 54 patients (90%). Analyses of other secondary endpoints showed that 2 patients (6.3%) presented asymptomatic radial artery occlusion. No allergies were reported.
This first-in-human trial using the Electroducer Sleeve indicated that this novel, purpose-built, temporary pacing device was safe and effective. Larger prospective studies are required to confirm these findings.
经导管主动脉瓣植入术（TAVI）和复杂经皮冠状动脉介入治疗（PCI）在器械输送过程中可能需要心脏起搏，通常需要通过额外的静脉入路插入临时起搏导线。专用的电发生器套管装置提供直接的电起搏，而无需临时静脉起搏器。
本研究评估了在 PCI 过程中使用新型套管装置进行临时心脏起搏的安全性。
这是一项多中心、非随机、前瞻性、首例人体、单臂、初步研究。主要终点是分析安全性结果，定义为器械血管入路部位出现血肿或出血并发症。次要终点包括有效性和定性结果分析。
来自法国 4 个中心的 60 例患者（平均年龄：77.9±9.6 岁）入组：39 例（65%）行 TAVI，21 例（35%）行 PCI。手术均采用套管经桡动脉（32 例；53.3%）或股动脉（26 例；43.3%）或股静脉（2 例；3.3%）入路。主要终点分析显示，2 例患者（3.3%）在器械入路部位出现 EArly Discharge After Transradial Stenting of CoronarY Arteries Study（EASY）Ⅰ级/Bleeding Academic Research Consortium（BARC）Ⅰ型血肿。作为有效性的衡量标准，在 54 例患者（90%）中，每次电刺激后均观察到血流动力学效应。其他次要终点分析显示，2 例患者（6.3%）出现无症状性桡动脉闭塞。未报告过敏反应。
这项使用 Electroducer Sleeve 的首例人体试验表明，这种新型专用临时起搏装置是安全有效的。需要更大规模的前瞻性研究来证实这些发现。
