主动脉瓣生物瓣膜安全性的系统评价与meta分析

目的 采用系统评价和meta分析的方法评价主动脉瓣置换术中使用生物瓣膜的远期安全性结局。方法 计算机系统检索Medline、Embase、Web of Science、CENTRAL、ClinicalTrial.gov、SinoMed、中国知网、维普和万方数据库在2000年1月1日至2019年1月26日期间发表的随机临床试验、非随机临床试验、队列研究和病例系列研究,纳入标准还包括使用生物瓣膜进行主动脉瓣膜置换术、平均随访时间≥5年、报告了相关安全性结局等。提取研究特征和相关数据,使用Stata 14.0进行meta分析。结果 最终纳入53篇文献共57个研究组,包含47 803名患者。(1)全因死亡率为6.33/100人年(95%CI:5.85~6.84),亚组分析结果显示,猪瓣膜和牛心包瓣膜的死亡率分别为5.69/100人年(95%CI:5.05~6.41)和7.29/100人年(95%CI:6.53~8.13);有支架和无支架瓣膜的死亡率分别为6.69/100人年(95%CI:6.12~7.30)和5.21/100人年(95%CI:4.43~6.14)。(2)血栓栓塞的发生率为1.16/100人年(95%CI:0.96~1.40),心脏起搏器植入率为1.08/100人年(95%CI:0.75~1.54),再手术率为0.77/100人年(95%CI:0.65~0.91),脑卒中的发生率为0.74/100人年(95%CI:0.51~1.06),结构性瓣膜退化的发生率为 0.73/100人年(95%CI:0.59~0.91),大出血的发生率为0.52/100人年(95%CI:0.41~0.65),心内膜炎的发生率为0.38/100人年(95%CI:0.33~0.44),非结构性瓣膜退化的发生率为0.20/100人年(95%CI:0.13~0.31)。结论 生物瓣膜的全因死亡率为6.33/100人年,血栓栓塞、心脏起搏器植入、再手术、脑卒中和结构性瓣膜退化是主要的远期并发症。

Safety of biological valves for aortic valve replacement: A systematic review and meta-analysis

Objective: To provide a comprehensive and contemporary overview of the long-term safety outcomes after aortic valve replacements (AVR) with conventional biological heart valve (stented or stentless).Methods: English databases (Medline, Embase, Web of Science, CENTRAL, and ClinicalTrial.gov) and Chinese databases (CNKI, VIP, WanFang, and SinoMed) were searched systemically from January 1, 2000 to January 26, 2019. Eligible randomized controlled trials, non-randomized clinical trials, cohort studies (retrospective or prospective), and unselected case series were included. Strict screening of the obtained literature was conducted to extract relevant data by two reviewers. Other inclusion criteria were studied reporting on outcomes of AVR with biological valves (stented or stentless), with or without coronary artery bypass grafting (CABG) or valve repair procedure, with mean follow-up length equal to or longer than 5 years. We excluded studies that reported only a specific patient group (e.g., patients with renal failure, or pregnancy), without the report of biological valve type, or with study population size less than 100. The meta-analysis was performed using Stata 14.0 software.Results: In this study, 53 papers (in total 57 study groups) involving 47 803 patients were included. (1) The all-cause mortality was 6.33/100 patient-years (95%CI: 5.85-6.84). Subgroup analysis showed that the mortality rates of porcine and bovine valve prostheses were 5.69/100 patient-years (95%CI: 5.05-6.41) and 7.29/100 patient-years (95%CI: 6.53-8.13), respectively. The all-cause mortality rates for stented and stentless valve were 6.69/100 patient-years (95%CI: 6.12-7.30) and 5.21/100 patient-years (95%CI: 4.43-6.14), respectively. (2) The incidence rate of thromboembolism was 1.16/100 patient-years (95%CI: 0.96-1.40), the incidence rate of permanent pacemaker (PPM) implantation was 1.08/100 patient-years (95%CI: 0.75-1.54), the incidence rate of stroke was 0.74/100 patient-years (95%CI: 0.51-1.06), the incidence rate of structural valve dysfunction (SVD) was 0.73/100 patient-years (95%CI: 0.59-0.91), the incidence rate of major bleeding was 0.52/100 patient-years (95%CI: 0.41-0.65), the incidence rate of endocarditis was 0.38/100 patient-years (95%CI: 0.33-0.44), and the incidence rate of non-structural valve dysfunction (NSVD) was 0.20/100 patient-years (95%CI: 0.13-0.31). The total reoperation rate for biological aortic valve was 0.77/100 patient-years (95%CI: 0.65-0.91), and the SVD related reoperation rate was 0.46/100 patient-years (95%CI: 0.36-0.58).Conclusion: The all-cause mortality for conventional biological AVR was 6.33/100 patient-years. Thromboembolism, PPM implantation, reoperation, stroke, and SVD were major long term complications.