Bogdan Ștefan, Bistriceanu Mircea Ioan Alexandru, Ursu Cosmin Gabriel, Anghel Andrei Constantin, Andreescu Darie Ioan, Ababei Alexandru, Deaconu Silvia, Deaconu Alexandru
Faculty of Medicine, Carol Davila University of Medicine and Pharmacy, 050474 Bucharest, Romania.
Department of Cardio-Thoracic Pathology, Faculty of Medicine, Carol Davila University of Medicine and Pharmacy, 050474 Bucharest, Romania.
Biomedicines. 2025 Aug 9;13(8):1952. doi: 10.3390/biomedicines13081952.
: Patients with end-stage renal disease (ESRD) are at elevated risk for device-related complications following pacemaker implantation. Leadless pacemakers (LPMs) offer theoretical advantages over transvenous pacemakers (TVPs), but their safety and efficacy in this high-risk population remain unclear. Our aim was to compare clinical outcomes and complication profiles between leadless and transvenous pacemakers in patients with ESRD. : We conducted a systematic review and meta-analysis according to PRISMA guidelines, including three retrospective studies comparing LPMs and TVPs in ESRD patients. The primary endpoint was overall complications post-implantation. Secondary outcomes included early mortality (within 30 days), access site complications, device-related events, thrombotic events, and respiratory complications. A random-effects model was used to pool odds ratios (ORs) and 95% confidence intervals (CIs). : Three studies comprising 10.075 ESRD patients were included. No significant difference was found in overall complications (OR 1.35, 95% CI 0.78-2.33, = 0.14) or early mortality (OR 1.01, 95% CI 0.42-2.43, = 0.97) between LPM and TVP groups. However, LPMs were associated with increased access site complications (OR 2.51, 95% CI 1.06-5.90, = 0.04), thrombotic events (OR 1.42, 95% CI 1.14-1.78, = 0.03), and respiratory complications (OR 1.43, 95% CI 1.01-2.03, = 0.05). Device-related complication rates were similar (OR, 1.09; 95% CI, 0.63-1.88; = 0.30). Heterogeneity was low across most outcomes. : Among patients with ESRD, leadless pacemakers did not reduce overall complications or short-term mortality compared to transvenous systems and were associated with increased risk of certain procedural complications. These findings could support a personalized approach to device selection in ESRD and highlight the need for further prospective studies to guide clinical decision-making in this population.
终末期肾病(ESRD)患者在植入起搏器后发生与器械相关并发症的风险较高。无导线起搏器(LPM)相较于经静脉起搏器(TVP)具有理论优势,但其在这一高危人群中的安全性和有效性仍不明确。我们的目的是比较ESRD患者中无导线起搏器和经静脉起搏器的临床结局及并发症情况。
我们根据PRISMA指南进行了一项系统评价和荟萃分析,纳入了三项比较ESRD患者中LPM和TVP的回顾性研究。主要终点是植入后的总体并发症。次要结局包括早期死亡率(30天内)、穿刺部位并发症、器械相关事件、血栓形成事件和呼吸并发症。采用随机效应模型汇总比值比(OR)和95%置信区间(CI)。
纳入了三项研究,共10075例ESRD患者。LPM组和TVP组在总体并发症(OR 1.35,95% CI 0.78 - 2.33,P = 0.14)或早期死亡率(OR 1.01,95% CI 0.42 - 2.43,P = 0.97)方面未发现显著差异。然而,LPM与穿刺部位并发症增加(OR 2.51,95% CI 1.06 - 5.90,P = 0.04)、血栓形成事件(OR 1.42,95% CI 1.14 - 1.78,P = 0.03)和呼吸并发症(OR 1.43,95% CI 1.01 - 2.03,P = 0.05)相关。器械相关并发症发生率相似(OR,1.09;95% CI,0.63 - 1.88;P = 0.30)。大多数结局的异质性较低。
在ESRD患者中,与经静脉系统相比,无导线起搏器并未降低总体并发症或短期死亡率,且与某些手术并发症风险增加相关。这些发现可为ESRD患者器械选择的个性化方法提供支持,并凸显进一步前瞻性研究以指导该人群临床决策的必要性。