1161例植入圣犹达医疗公司和ATS开放式枢轴机械心脏瓣膜患者的单中心结局分析。

Single-center outcome analysis of 1,161 patients with St. Jude medical and ATS open pivot mechanical heart valves.

作者信息

Bernet Franziska H, Baykut Doan, Grize Leticia, Zerkowski Hans-Reinhard

机构信息

Division of Cardio-Thoracic Surgery, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland.

出版信息

J Heart Valve Dis. 2007 Mar;16(2):151-8.

PMID:17484464

Abstract

BACKGROUND AND AIM OF THE STUDY

The clinical performance of mechanical heart valves and valve-related complications are important safety endpoints in patients after heart valve replacement. In this retrospective analysis, the mid- to long-term clinical outcomes of two similar bileaflet heart valves, routinely implanted at the authors' institution over an 11-year period, were compared.

METHODS

Between January 1993 and December 2003, a total of 1,161 patients (758 males, 403 females) received either a St. Jude Medical (SJM) or ATS mechanical heart valve. Follow up was obtained via an in-house Quality Management Database, ascertained by telephone questionnaire of the patients and/or family physicians. Follow up was 98.9% complete; the median follow up was 4.6 years; total follow up was 5,624 patient-years (pt-yr).

RESULTS

A total of 604 SJM and 601 ATS prostheses was implanted as isolated (n = 669) or combined (n = 492) procedures. The overall 30-day mortality for SJM and ATS was 4.1% and 3.4%, respectively (p = 0.45). Cumulative survival and freedom from valve-related mortality at 10 years for SJM and ATS valves were 66 +/- 3% versus 68 +/- 5% (p = 0.84) and 96 +/- 1% versus 97 +/- 1% (p = 0.36), respectively. No structural valve failure was encountered for both valve types. Freedom from overall valve-related complications at 10 years was 79 +/- 4% for SJM and 66 +/- 6% for ATS (p = 0.08). The linearized rates for valve-related adverse events for SJM and ATS valves, respectively, were: thromboembolism 0.9 and 1.1%/pt-yr; major bleeding requiring transfusion 0.3 and 0.5%/pt-yr; prosthetic endocarditis 0.03 and 0.1%/pt-yr; paravalvular leak 0.1 and 0.6%/pt-yr.

CONCLUSION

On the basis of an 11-year experience, both bileaflet valves showed very good clinical results, with low incidences of adverse events during the mid-term outcome. Gender and/or concomitant coronary artery disease were not predictors for reduced life expectancy.

摘要

研究背景与目的

机械心脏瓣膜的临床性能及瓣膜相关并发症是心脏瓣膜置换术后患者重要的安全性终点。在这项回顾性分析中，比较了作者所在机构在11年期间常规植入的两种相似双叶心脏瓣膜的中长期临床结果。

方法

1993年1月至2003年12月期间，共有1161例患者（758例男性，403例女性）接受了圣犹达医疗（SJM）或ATS机械心脏瓣膜植入。通过内部质量管理数据库进行随访，通过对患者和/或家庭医生的电话问卷调查确定随访情况。随访完成率为98.9%；中位随访时间为4.6年；总随访时间为5624患者年（pt-yr）。

结果

共植入604个SJM和601个ATS人工瓣膜，手术方式为单纯植入（n = 669）或联合植入（n = 492）。SJM和ATS的总体30天死亡率分别为4.1%和3.4%（p = 0.45）。SJM和ATS瓣膜在10年时的累积生存率及无瓣膜相关死亡率分别为66 ± 3%对68 ± 5%（p = 0.84）和96 ± 1%对97 ± 1%（p = 0.36）。两种瓣膜类型均未出现结构性瓣膜失效。SJM和ATS瓣膜在10年时无总体瓣膜相关并发症的发生率分别为79 ± 4%和66 ± 6%（p = 0.08）。SJM和ATS瓣膜瓣膜相关不良事件的线性化发生率分别为：血栓栓塞0.9和1.1%/pt-yr；需要输血的大出血0.3和0.5%/pt-yr；人工瓣膜心内膜炎0.03和0.1%/pt-yr；瓣周漏0.1和0.6%/pt-yr。