索林碳酸氢盐人工瓣膜患者瓣膜相关并发症的评估：七年经验

Bortolotti U, Milano A, D'Alfonso A, Piccin C, Mecozzi G, Magagna P, Fabbri A, Mazzucco A

Division of Cardiac Surgery, Cardiac and Thoracic Department, University of Pisa, Italy.

J Heart Valve Dis. 2001 Nov;10(6):795-801.

BACKGROUND AND AIM OF THE STUDY

The study aim was to evaluate the medium-term results of aortic valve replacement (AVR), mitral valve replacement (MVR) and double valve replacement (DVR) with the Sorin Bicarbon prosthesis.

METHODS

A total of 990 patients (568 men, 422 women; mean age 60+/-10 years; range: 20-86 years) was reviewed who received 1,108 Sorin Bicarbon prostheses between 1992 and 1998 at three institutions. AVR was performed in 541 patients (55%), MVR in 330 (33%) and DVR in 119 (12%). Concomitant procedures, mainly coronary artery grafting, were performed in 222 patients (22%). Follow up was 98% complete; total cumulative follow up was 3,091 patient-years.

RESULTS

Hospital mortality was 3.7% (n = 37). There were 49 late deaths; actuarial survival at seven years was 88+/-2% after AVR, 86+/-5% after MVR, and 78+/-8% after DVR. At last follow up, 915 survivors were in NYHA functional class I or II. At seven years, actuarial freedom from valve-related deaths, valve thrombosis, embolism and bleeding respectively was 96+/-1%, 99+/-1%, 93+/-2% and 91+/-3% after AVR; 97+/-2%, 97+/-3%, 90+/-3% and 86+/-7% after MVR; and 92+/-6%, 98+/-1%, 64+/-2% and 82+/-2% after DVR. Reoperation was required in 20 patients (due to valve thrombosis in six, endocarditis in five and periprosthetic leak in nine). At seven years, actuarial freedom from reoperation was 97+/-1%, 96+/-2% and 84+/-9% after AVR, MVR and DVR, respectively; actuarial freedom from endocarditis was 99+/-1%, 99+/-1% and 95+/-5%. Nine patients experienced a nonstructural valve dysfunction (all periprosthetic leak), while no cases of structural failure were observed.

CONCLUSION

The Sorin Bicarbon prosthesis has shown good medium-term results with regard to clinical improvement, and low incidence of valve-related complications. Thus, it appears to be a reliable valve substitute when the use of a mechanical prosthesis is indicated.

研究背景与目的

本研究旨在评估使用索林碳酸氢盐人工瓣膜进行主动脉瓣置换术（AVR）、二尖瓣置换术（MVR）和双瓣膜置换术（DVR）的中期结果。

方法

回顾了1992年至1998年间在三家机构接受1108枚索林碳酸氢盐人工瓣膜的990例患者（568例男性，422例女性；平均年龄60±10岁；范围：20 - 86岁）。541例患者（55%）接受了AVR，330例（33%）接受了MVR，119例（12%）接受了DVR。222例患者（22%）进行了同期手术，主要是冠状动脉搭桥术。随访完成率为98%；总累积随访时间为3091患者年。

结果

医院死亡率为3.7%（n = 37）。有49例晚期死亡；AVR术后7年的精算生存率为88±2%，MVR术后为86±5%，DVR术后为78±8%。在最后一次随访时，915名幸存者处于纽约心脏协会（NYHA）心功能I或II级。7年时，AVR术后瓣膜相关死亡（VAD）、瓣膜血栓形成、栓塞和出血的精算无事件生存率分别为96±1%、99±1%、93±2%和91±3%；MVR术后分别为97±2%、97±3%、90±3%和86±7%；DVR术后分别为92±6%、98±1%、64±2%和82±2%。20例患者需要再次手术（6例因瓣膜血栓形成，5例因心内膜炎，9例因人工瓣膜周漏）。7年时，AVR、MVR和DVR术后再次手术的精算无事件生存率分别为97±1%、96±2%和84±9%；心内膜炎的精算无事件生存率分别为99±1%、99±1%和95±5%。9例患者出现非结构性瓣膜功能障碍（均为人工瓣膜周漏），未观察到结构性失效病例。