Faculty of Medicine, University of Porto, Porto, Portugal -
Faculty of Medicine, University of Porto, Porto, Portugal.
Minerva Cardiol Angiol. 2021 Jun;69(3):346-357. doi: 10.23736/S2724-5683.20.05244-5. Epub 2020 Jul 10.
Transvenous pacemakers are associated with a significant amount of complications. Leadless pacemakers (LP) are emerging as an alternative to conventional devices. This article provides a systematic review of patient eligibility, safety and clinical outcomes of the LP devices.
A systematic search for articles describing the use of LP was conducted. Out of two databases, 24 articles were included in the qualitative analysis. These articles comprised a total of 4739 patients, with follow-up times of 1-38 months. Further information was obtained from 10 more studies.
From a population of 4739 patients included in the qualitative analysis, 4670 LP were implanted with success (98.5%). A total of 248 complications were described (5.23%) during the follow-up. The most common were pacing issues such as elevated thresholds, dislodgements or battery failure (68 patients), events at the femoral access site such as hemorrhage, hematoma or pseudoaneurysms (64 patients) and procedure related cardiac injuries such as cardiac perforation, tamponade or pericardial effusion (47 patients). There were 360 deaths during the follow-up and 11 were described as procedure or device related. Four studies presented the strategy of using a combined approach of atrioventricular node ablation (AVNA) and LP implantation.
Leadless pacemakers seem to have a relatively low complication rate. These devices may be a good option in patients with an indication for single-chamber pacing, in patients with conditions precluding conventional transvenous pacemaker implantations. Studies directly comparing LP and transvenous pacemakers and data on longer follow-up periods are needed.
经静脉起搏器与大量并发症相关。无导线起搏器 (LP) 作为传统设备的替代方案正在出现。本文对 LP 设备的患者适应证、安全性和临床结果进行了系统评价。
系统搜索了描述 LP 使用情况的文章。从两个数据库中，纳入了 24 篇定性分析文章。这些文章共纳入了 4739 例患者，随访时间为 1-38 个月。还从另外 10 项研究中获得了更多信息。
在定性分析中纳入的 4739 例患者中，有 4670 例 LP 成功植入（98.5%）。在随访期间共描述了 248 例并发症（5.23%）。最常见的是起搏问题，如阈值升高、脱位或电池故障（68 例）、股动脉入路部位的事件，如出血、血肿或假性动脉瘤（64 例）和与程序相关的心脏损伤，如心脏穿孔、心脏压塞或心包积液（47 例）。在随访期间有 360 例死亡，其中 11 例被描述为与程序或设备相关。四项研究提出了房室结消融 (AVNA) 和 LP 植入联合应用的策略。
无导线起搏器似乎并发症发生率相对较低。这些设备可能是有单腔起搏适应证的患者和有传统经静脉起搏器植入禁忌证的患者的良好选择。需要直接比较 LP 和经静脉起搏器的研究以及更长随访期的数据。
