Health Technology Assessment Area-AETSA, Andalusian Public Foundation Progress and Health-FPS, Seville, Spain.
Cardiology Department, Virgen Macarena University Hospital, Seville, Spain.
Pacing Clin Electrophysiol. 2023 May;46(5):358-364. doi: 10.1111/pace.14699. Epub 2023 Apr 13.
Leadless pacemakers were developed to reduce complications associated with transvenous pacemaker implantation and long-term follow-up. Existing international guidelines lack detailed instructions on patients suitable for leadless pacemaker implantation. Our aim was to develop a consensus document that provides medical guidance for all health professionals involved in the indication and implantation of Transcatheter Pacing System single-chamber device (VR leadless) pacemakers for patients with atrial fibrillation or in sinus rhythm.
A panel of experts, including interventional and non-interventional cardiologists, used the Research ANd Development/University of California at Los Angeles (RAND/UCLA) method to rate the appropriateness of leadless pacemaker implantation for 64 scenarios in patients with atrial fibrillation and 192 scenarios in sinus rhythm. The scenarios were rated individually and again during a moderated group session. Median ratings and level of agreement were calculated to classify each scenario as appropriate, inappropriate, or questionable.
This consensus statement, based on available literature and the experts' opinions, summarizes recommendations for standardizing and optimizing leadless pacemaker implantation. The limitation for vascular access via the superior vena cava was the most influential variable when indicating leadless pacemaker implantation in both patients with atrial fibrillation and patients in sinus rhythm.
Life expectancy, risk of infection, prosthetic valve, left ventricular ejection fraction (LVEF), limitation for vascular access via the superior vena cava, and mobility and exercise capacity determine who is advised to undergo VR leadless pacemaker implantation. More prospective studies are needed to optimize existing recommendations.
无导线起搏器的开发旨在降低与经静脉起搏器植入和长期随访相关的并发症。现有的国际指南缺乏关于适合植入无导线起搏器患者的详细说明。我们的目的是制定一份共识文件，为所有参与经导管起搏系统单腔装置（VR 无导线）起搏器适应证和植入的医疗保健专业人员提供医学指导，适用于房颤或窦性心律患者。
一个专家小组，包括介入心脏病学家和非介入心脏病学家，使用研究与开发/加利福尼亚大学洛杉矶分校（RAND/UCLA）方法，对 64 种房颤患者和 192 种窦性心律患者的无导线起搏器植入场景进行了适宜性评分。这些场景分别进行了评分，并在一次小组讨论会上再次进行了评分。中位数评分和一致性水平用于将每个场景分类为适宜、不适宜或可疑。
该共识声明基于现有文献和专家意见，总结了标准化和优化无导线起搏器植入的建议。在房颤和窦性心律患者中，经上腔静脉血管通路的限制是指示无导线起搏器植入的最具影响力的变量。
预期寿命、感染风险、人工瓣膜、左心室射血分数（LVEF）、经上腔静脉血管通路的限制以及活动能力和运动能力决定了建议哪些患者接受 VR 无导线起搏器植入。需要更多的前瞻性研究来优化现有的建议。
