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牛心包与猪生物二尖瓣瓣膜:来自韩国全国队列研究的结果。

Bovine pericardial versus porcine bioprosthetic mitral valves: results from a Korean Nationwide Cohort Study.

机构信息

Department of Thoracic and Cardiovascular Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.

Department of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.

出版信息

Eur J Cardiothorac Surg. 2023 Jun 1;63(6). doi: 10.1093/ejcts/ezad165.

DOI:10.1093/ejcts/ezad165
PMID:37115646
Abstract

OBJECTIVES

Comparisons of long-term clinical outcomes of mitral valve replacement (MVR) between bovine pericardial and porcine bioprostheses are conflicting, with limited research in large-scale real-world clinical settings. This study examined clinical outcomes in MVR according to bioprosthesis type using a national administrative claims database.

METHODS

This study included adult patients undergoing bioprosthetic MVR between 2003 and 2018 using administrative health care data from the Korean National Health Insurance Service database. Propensity score matching with competing risk analysis was used to compare the clinical outcomes according to the type of bioprosthesis. The end points were death, cardiac death, and valve-related events, including the incidence of reoperation, endocarditis, systemic thromboembolism, and major bleeding.

RESULTS

A total of 3151 patients underwent bioprosthetic MVR with bovine pericardial (n = 1628, 51.7%) or porcine (n = 1523, 48.3%) bioprostheses. After matching, 1170 pairs were included in the final analysis. During follow-up (median 4.49 years, interquartile range 1.87 -8.75 years), death occurred in 1178 patients (6.8%/patient-year), comprising 730 (4.3%/patient-year) cardiac death. No significant differences were noted between the bovine and porcine groups in the cumulative incidences of death from any cause [adjusted hazard ratio (aHR), 1.00; 95% confidence interval (CI), 0.87-1.14], cardiac mortality (aHR, 0.96; 95% CI, 0.81-1.14), or reoperation (aHR, 1.01; 95% CI, 0.72-1.41).

CONCLUSIONS

This study on a nationwide comparison between bovine and porcine bioprostheses in MVR found no significant differences in clinical outcomes including mortality, and valve-related reoperation.

摘要

目的

牛心包和猪生物瓣二尖瓣置换术(MVR)的长期临床结局比较存在争议,在大规模真实临床环境中的研究有限。本研究使用国家行政索赔数据库,根据生物瓣类型检查 MVR 的临床结局。

方法

本研究纳入了 2003 年至 2018 年期间使用韩国国家健康保险服务数据库的行政医疗保健数据接受生物瓣 MVR 的成年患者。采用竞争风险分析的倾向评分匹配比较生物瓣类型的临床结局。终点是死亡、心源性死亡和瓣膜相关事件,包括再次手术、心内膜炎、全身性血栓栓塞和大出血的发生率。

结果

共有 3151 例患者接受了牛心包(n=1628,51.7%)或猪(n=1523,48.3%)生物瓣的 MVR。匹配后,最终分析纳入了 1170 对。在随访期间(中位数 4.49 年,四分位距 1.87-8.75 年),1178 例患者发生死亡(6.8%/患者年),其中 730 例为心源性死亡(4.3%/患者年)。牛心包组和猪组之间任何原因导致的死亡率[校正后的危险比(aHR),1.00;95%置信区间(CI),0.87-1.14]、心源性死亡率(aHR,0.96;95%CI,0.81-1.14)或再次手术(aHR,1.01;95%CI,0.72-1.41)的累积发生率无显著差异。

结论

本研究对全国范围内 MVR 中牛心包和猪生物瓣的比较发现,在死亡率和瓣膜相关再手术等临床结局方面无显著差异。

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