Cardiology Unit, "Card. G. Panico" Hospital, Tricase, Italy.
SOC Cardiologia-Dipartimento Cardiotoracico, Azienda Sanitaria Universitaria Friuli Centrale, Udine, Italy.
Europace. 2023 Feb 8;25(1):112-120. doi: 10.1093/europace/euac112.
The safety and efficacy of leadless intracardiac-permanent pacemaker (L-PM) have been demonstrated in multiple clinical trials, but data on comparisons with conventional transvenous-permanent pacemaker (T-PM) collected in a consecutive, prospective fashion are limited. The aim of this analysis was to compare the rate and the nature of device-related complications between patients undergoing L-PM vs. T-PM implantation.
Prospective, multicentre, observational project enrolling consecutive patients who underwent L-PM or T-PM implantation. The rate and nature of device-related complications were analysed and compared between the two groups. Individual 1:1 propensity matching of baseline characteristics was performed. A total of 2669 (n = 665 L-PM) patients were included and followed for a median of 39 months, L-PM patients were on average older and had more co-morbidities. The risk of device-related complications at 12 months was significantly lower in the L-PM group (0.5% vs. 1.9%, P = 0.009). Propensity matching yielded 442 matched pairs. In the matched cohort, L-PM patients trended toward having a lower risk of overall device-related complications (P = 0.129), had a similar risk of early complications (≤30 days) (P = 1.000), and had a significantly lower risk of late complications (>30 days) (P = 0.031). All complications observed in L-PM group were early. Most (75.0%) of complications observed in T-PM group were lead- or pocket-related.
In this analysis, the risk of device-related complications associated with L-PM implantation tended to be lower than that of T-PM. Specifically, the risk of early complications was similar in two types of PMs, while the risk of late complications was significantly lower for L-PM than T-PM.
无导线心脏永久起搏器（L-PM）的安全性和有效性已在多项临床试验中得到证实，但在连续前瞻性收集的常规经静脉永久起搏器（T-PM）数据有限。本分析旨在比较接受 L-PM 与 T-PM 植入的患者之间与器械相关的并发症发生率和性质。
前瞻性、多中心、观察性研究纳入连续接受 L-PM 或 T-PM 植入的患者。分析并比较了两组患者器械相关并发症的发生率和性质。对基线特征进行了个体 1:1 倾向匹配。共纳入 2669 例（n = 665 例 L-PM）患者，中位随访时间为 39 个月，L-PM 患者年龄较大且合并症较多。L-PM 组 12 个月时器械相关并发症的风险显著较低（0.5% vs. 1.9%，P = 0.009）。进行倾向匹配后得到 442 对匹配对。在匹配队列中，L-PM 患者的总体器械相关并发症风险较低（P = 0.129），早期并发症（≤30 天）的风险相似（P = 1.000），晚期并发症（>30 天）的风险显著较低（P = 0.031）。L-PM 组观察到的所有并发症均为早期并发症。T-PM 组观察到的并发症中，大多数（75.0%）与导线或囊袋相关。
在本分析中，与 L-PM 植入相关的器械相关并发症的风险似乎低于 T-PM。具体而言，两种 PM 的早期并发症风险相似，而 L-PM 的晚期并发症风险明显低于 T-PM。
