Mhasseb Cedric, Kiwan Mayassa, Merhi Marie-Elie, Moussallem Nicolas, Moussalli Jana, Zeid Maroun Abou, Daher Sarah Abou, Nabbout Ghassan, Azar Sami, Kanaan Amjad, Harb Frederic
Faculty of Medicine and Medical Sciences, University of Balamand, Kalhat, Lebanon.
Heliyon. 2024 Dec 9;11(1):e40982. doi: 10.1016/j.heliyon.2024.e40982. eCollection 2025 Jan 15.
Transvenous pacemakers (TVP) and leadless pacemakers (LP) are two reliable permanent modalities for the treatment of heart rhythm disorders. Several observational studies explored the safety and efficacy of the two devices. The aim of this meta-analysis study is to present a comparative analysis of the safety of leadless versus transvenous pacemakers.
The study protocol was registered in PROSPERO registry (CRD42024520647). A comprehensive and systematic search was conducted across PubMed, Embase, Cochrane Library, Web of Science and ClinicalTrials.gov, spanning from inception until just before the final analysis. SPSS was used for statistical analysis. Relative risks (RR) and odds ratio (OR) were used to evaluate the outcomes with a 95 % confidence interval (CI).
Nineteen studies met the inclusion criteria and were analyzed, in which the overall effect estimate showed increased risk of major complications in the TVP group (LogOR = -0.27, 95 % CI: [-0.63, 0.10]) compared to the LP group. Among the nineteen studies, seven studies showed that TVP significantly increase the risk of reintervention (LogOR = -0.73, 95 % CI: [-1.15, -0.31]) and thirteen studies showed a higher risk of mortality among patients receiving TVP (Cohen's d = -0.11, 95 % CI: [-0.22, 0.01]) compared to those receiving LP. Conversely, a higher risk of pericardial effusion or tamponade and thromboembolic events was among patients receiving LP with (LogOR = 1.01, 95 % CI: [0.55, 1.46]) and (LogOR = 0.45, 95 % CI: [-0.33, 1.23]) respectively.
This study showed that leadless pacemakers tend to be safer compared to transvenous pacemakers, with reduced risks of major complications, reintervention, generator malfunction, device or lead dislodgement, pneumothorax and hemothorax, infections rates, and mortality. However, higher odds of cardiac perforation and tamponade and thromboembolic events were observed among patients receiving LP. The lack of both randomized clinical trials and long term follow up studies limits our assessment and emphasizes the need for ongoing investigation to understand the extended complications associated with these devices amidst advancing technology.
经静脉起搏器（TVP）和无导线起搏器（LP）是治疗心律紊乱的两种可靠的永久性方式。多项观察性研究探讨了这两种装置的安全性和有效性。这项荟萃分析研究的目的是对无导线起搏器与经静脉起搏器的安全性进行比较分析。
该研究方案已在PROSPERO注册库（CRD42024520647）中注册。在PubMed、Embase、Cochrane图书馆、科学网和临床试验.gov上进行了全面系统的检索，涵盖从开始到最终分析前的时间段。使用SPSS进行统计分析。相对风险（RR）和比值比（OR）用于评估结果，并给出95%置信区间（CI）。
19项研究符合纳入标准并进行了分析，总体效应估计显示，与LP组相比，TVP组发生主要并发症的风险增加（对数OR = -0.27，95% CI：[-0.63, 0.10]）。在这19项研究中，7项研究表明TVP显著增加再次干预的风险（对数OR = -0.73，95% CI：[-1.15, -0.31]），13项研究表明接受TVP的患者死亡率高于接受LP的患者（科恩d值 = -0.11，95% CI：[-0.22, 0.01]）。相反，接受LP的患者发生心包积液或心包填塞以及血栓栓塞事件的风险较高，分别为（对数OR = 1.01，95% CI：[0.55, 1.46]）和（对数OR = 0.45，95% CI：[-0.33, 1.23]）。
本研究表明，与经静脉起搏器相比，无导线起搏器往往更安全，主要并发症、再次干预、发生器故障、装置或导线移位、气胸和血胸、感染率及死亡率的风险均降低。然而，接受LP的患者发生心脏穿孔、心包填塞和血栓栓塞事件的几率更高。缺乏随机临床试验和长期随访研究限制了我们的评估，并强调需要持续进行调查，以了解在技术不断进步的情况下与这些装置相关的更多并发症。
