Sorin 碳酸氢盐超过 15 年的临床结果：1704 例患者的多中心经验。

The Sorin Bicarbon over 15 years clinical outcomes: multicentre experience in 1704 patients.

机构信息

Groupe Hospitalier Saint Jacques, Clermont Ferrand, France.

出版信息

Eur J Cardiothorac Surg. 2010 Dec;38(6):759-66. doi: 10.1016/j.ejcts.2010.03.060. Epub 2010 May 14.

DOI:10.1016/j.ejcts.2010.03.060

PMID:20471851

Abstract

OBJECTIVES

To present the results of a 15-year follow-up of the Sorin Bicarbon prosthesis (SBP) from a European multicentre study.

METHODS

From 1990 to 1996, a total of 1900 SBPs were implanted in 1704 patients, with a mean age of 59±13 years, as aortic (AVR, 922 patients), mitral (MVR, 586) or mitro-aortic (DVR, 196) valve replacement. Most patients received an SBP for rheumatic or degenerative valve disease. Concomitant procedures were performed in 25% of cases, mainly coronary artery bypass grafting (14%) or tricuspid annuloplasty (7%).

RESULTS

There were 70 (4.1%) early deaths. Actuarial survival at 15 years is 61.4% (95% confidence interval (CI): 56.4-66.0) for AVR, 63.4% (59.1-67.5) for MVR, 56.4% (47.3-64.6) for DVR. Late valve-related deaths were 260 with an actuarial freedom from valve-related deaths at 15 years of 76.4% (81.5-83.7). There were 27 cases of SBP thrombosis with an actuarial freedom from this complication at 15 years of 99.6% (98.6-99.9) after AVR, 95.8% (93.0-97.5) after MVR and 97.0% (92.8-98.7) after DVR. Thrombo-embolic episodes were 159; actuarial freedom from thrombo-embolism at 15 years is 88.8% (86.8-90.5). Haemorrhages related to anticoagulant treatment occurred in 293 cases with 39 fatal episodes; actuarial freedom at 15 years is 77.5% (74.2-80.4). There were 45 episodes of endocarditis, 21 required re-operation; actuarial freedom from endocarditis at 15 years is 96.8% (95.6-97.7). Re-operation was performed in 71 patients (non-structural valve deterioration in 28, endocarditis in 21, SBP thrombosis in 15 and non-valve-related causes in seven patients). No cases of structural failure were observed. Actuarial freedom from re-operation at 15 years is 97.6% (96.3-98.5) after AVR, 92.8% (90.1-94.8) after MVR and 90.7% (85.2-94.2) after DVR.

CONCLUSIONS

The SBP continues to perform satisfactorily even in the long term with low incidence of valve-related mortality and morbidity confirming to be an extremely reliable and durable mechanical valve substitute.

摘要

目的

呈现来自欧洲多中心研究的索林碳酸氢盐假体（SBP） 15 年随访结果。

方法

1990 年至 1996 年，共对 1704 例患者的 1900 个 SBP 进行了植入，平均年龄为 59±13 岁，主动脉瓣置换术（AVR，922 例）、二尖瓣置换术（MVR，586 例）或二尖瓣主动脉瓣置换术（DVR，196 例）。大多数患者因风湿性或退行性瓣膜病而接受 SBP 治疗。25%的病例同时进行了伴随手术，主要是冠状动脉旁路移植术（14%）或三尖瓣环成形术（7%）。

结果

共有 70 例（4.1%）早期死亡。15 年的累积生存率为：AVR 为 61.4%（95%置信区间：56.4-66.0），MVR 为 63.4%（59.1-67.5），DVR 为 56.4%（47.3-64.6）。晚期与瓣膜相关的死亡为 260 例，15 年瓣膜相关死亡率为 76.4%（81.5-83.7）。有 27 例 SBP 血栓形成，15 年后 SBP 血栓形成的无并发症生存率为 99.6%（98.6-99.9），AVR 后为 95.8%（93.0-97.5），MVR 后为 97.0%（92.8-98.7）。血栓栓塞事件为 159 例，15 年血栓栓塞无事件生存率为 88.8%（86.8-90.5）。与抗凝治疗相关的出血发生在 293 例患者中，其中 39 例为致命性，15 年累积生存率为 77.5%（74.2-80.4）。有 45 例心内膜炎，21 例需要再次手术，15 年无心内膜炎生存率为 96.8%（95.6-97.7）。71 例患者进行了再手术（28 例为非结构性瓣膜恶化，21 例为心内膜炎，15 例为 SBP 血栓形成，7 例为非瓣膜相关原因）。未观察到结构性瓣膜失效病例。15 年后的无再手术生存率为：AVR 后为 97.6%（96.3-98.5），MVR 后为 92.8%（90.1-94.8），DVR 后为 90.7%（85.2-94.2）。