Department of Vascular Surgery, Aristotle University of Thessaloniki, AHEPA University General Hospital, Thessaloniki, Greece.
Department of Anesthesiology and Intensive Care, Aristotle University of Thessaloniki, AHEPA University General Hospital, Thessaloniki, Greece.
Thromb Res. 2022 Oct;218:130-137. doi: 10.1016/j.thromres.2022.08.022. Epub 2022 Aug 23.
To evaluate the safety and efficacy of perioperative bridging in patients with mechanical heart valves undergoing non-cardiac interventions.
A systematic research using Medline, EMBASE, and Google Scholar was implemented corresponding to the Preferred Reporting Items for Systematic reviews and Meta-analysis (PRISMA) statement. Data from the eligible studies were obtained and meta-analyzed. Primary endpoints included major bleeding and thromboembolism. Secondary endpoints included minor bleeding, overall mortality, and overall bleeding (major and minor bleeding). We conducted a comparative analysis between bridging and non-bridging along with a sensitivity analysis for patients undergoing major and minor operations.
Fifteen studies comprised of 2305 patients (2453 bridging episodes) were included. Pooled major bleeding and thromboembolism rates were 3.85 % (95 % CI: 2.12-5.98) (I = 69 %, p < 0.01) and 0.39 % (95 % CI: 0.00-1.41) (I = 64 %, p < 0.01). Bridging versus non-bridging major bleeding, thromboembolism, and overall bleeding risk ratios (RR) were RR 2.05 (95 % CI: 0.98-4.28) (I = 10 %, p = 0.34), RR 1.63 (95 % CI: 0.41-6.50) (I = 0 %, p = 0.63) and RR 1.79 (95 % CI: 1.17-2.72) (I = 55 %, p = 0.09) respectively. Subgroup analysis displayed major and minor operation thromboembolism and overall bleeding rates of 3.09 % (95 % CI: 0.78-6.43) (I = 0 %, p = 0.89) versus 0.14 % (95 % CI: 0.00-1.40) (I = 0 %, p = 0.93), test for subgroup differences (p < 0.01) and 17.37 % (95 % CI: 11.73-23.77) (I = 0 %, p = 0.61) versus 28.18 % (95 % CI: 22.80-33.88) (I = 0 %, p = 0.47), test for subgroup differences (p = 0.01) respectively.
Our analysis suggests that bridging may potentially put patients at an increased bleeding risk regarding overall bleeding rates, while failing to provide statistically significant benefits concerning thromboembolism and overall mortality compared to non-bridging. Limitations such as the mixed patient population don't allow for definite conclusions to be drawn warrantying further research through randomized controlled trials.
评估机械心脏瓣膜患者行非心脏介入治疗时围手术期桥接治疗的安全性和有效性。
根据系统评价和荟萃分析的首选报告项目(PRISMA)声明,使用 Medline、EMBASE 和 Google Scholar 进行了系统研究。获取并进行了荟萃分析纳入研究的数据。主要终点包括大出血和血栓栓塞。次要终点包括小出血、总死亡率和总出血(大出血和小出血)。我们对桥接和非桥接进行了对比分析,并对行大、小手术的患者进行了敏感性分析。
共纳入了 15 项研究,包含 2305 例患者(2453 例桥接发作)。汇总的大出血和血栓栓塞发生率分别为 3.85%(95%CI:2.12-5.98)(I=69%,p<0.01)和 0.39%(95%CI:0.00-1.41)(I=64%,p<0.01)。桥接与非桥接的大出血、血栓栓塞和总出血风险比(RR)分别为 RR 2.05(95%CI:0.98-4.28)(I=10%,p=0.34)、RR 1.63(95%CI:0.41-6.50)(I=0%,p=0.63)和 RR 1.79(95%CI:1.17-2.72)(I=55%,p=0.09)。亚组分析显示大、小手术的血栓栓塞和总出血发生率分别为 3.09%(95%CI:0.78-6.43)(I=0%,p=0.89)和 0.14%(95%CI:0.00-1.40)(I=0%,p=0.93),组间差异检验(p<0.01)和 17.37%(95%CI:11.73-23.77)(I=0%,p=0.61)和 28.18%(95%CI:22.80-33.88)(I=0%,p=0.47),组间差异检验(p=0.01)。
我们的分析表明,桥接治疗可能会增加患者的总体出血风险,但与非桥接治疗相比,在血栓栓塞和总体死亡率方面并未提供统计学上的显著获益。混合患者人群等局限性不允许得出明确的结论,需要通过随机对照试验进一步研究。