圣犹达医疗公司和卡博梅迪克斯公司人工心脏瓣膜的长期效果。

Long-term results with St. Jude Medical and CarboMedics prosthetic heart valves.

作者信息

Chang B C, Lim S H, Kim D K, Seo J Y, Cho S Y, Shim W H, Chung N, Kim S S, Cho B K

机构信息

Divisions of Cardiovascular Surgery, Yonsei Cardiovascular Center, Yonsei University College of Medicine, Seoul, South Korea.

出版信息

J Heart Valve Dis. 2001 Mar;10(2):185-194; discussion195.

PMID:11297205

Abstract

BACKGROUND AND AIM OF THE STUDY

The clinical evaluation and comparison of St. Jude Medical (SJM) and CarboMedics (CM) prosthetic heart valves implanted between 1988 and 1997 is presented.

METHODS

In total, 648 SJM valves were implanted in 641 patients, and 601 CM valves in 591 patients. There were 684 mitral valve replacements, 256 aortic valve replacements, 252 mitral and aortic (double) valve replacements, 16 triple valve replacements, and 41 other tricuspid-related valve replacements. Total follow up was 98%. The overall incidence of valve-related events was compared before and after establishment of a 'valve clinic' in 1993.

RESULTS

The overall hospital mortality was 3.4%; late mortality was 8.2%. The five- and ten-year survival for all patients was 92.1% and 86.2%, respectively. There were 31 episodes of thromboembolism in 27 patients (including valve thrombosis in three), 21 episodes of bleeding events in 20 patients, and 18 re-replacements of implanted valves. No structural valve deterioration was observed. Freedom from thromboembolism was 97.8% at five years and 96.3% at ten years; freedom from bleeding episodes was 98.1% and 97.6%, respectively. In terms of hospital and late mortality, and incidence of thromboembolism, hemorrhagic episodes and structural valve failure, no statistically significant differences were found between the SJM and CarboMedics patient groups. Freedom from thromboembolism was 96.7% at five years before initiation of an intensive follow up program, and 99.0% thereafter (p = 0.031). In contrast, freedom from bleeding episodes fell from 99.3% to 96.1% during the same time period (p = 0.0004).

CONCLUSION

Both the SJM and CM prosthetic heart valves performed well in our study, and no discernible differences in clinical performance of the two valves were detected. The intensive follow up program resulted in a reduced incidence of thromboembolism, but an increased number of bleeding complications. An optimum anticoagulation regimen to manage these two conflicting problems has yet to be elucidated.

摘要

研究背景与目的

本文介绍了1988年至1997年间植入的圣犹达医疗公司（SJM）和卡博梅迪克斯公司（CM）人工心脏瓣膜的临床评估与比较。

方法

共641例患者植入了648枚SJM瓣膜，591例患者植入了601枚CM瓣膜。其中二尖瓣置换684例，主动脉瓣置换256例，二尖瓣与主动脉瓣（双瓣）置换252例，三尖瓣置换16例，其他与三尖瓣相关的瓣膜置换41例。总随访率为98%。比较了1993年设立“瓣膜诊所”前后瓣膜相关事件的总体发生率。

结果

总体医院死亡率为3.4%；晚期死亡率为8.2%。所有患者的5年和10年生存率分别为92.1%和86.2%。27例患者发生31次血栓栓塞事件（包括3例瓣膜血栓形成），20例患者发生21次出血事件，18例患者进行了再次瓣膜置换。未观察到瓣膜结构恶化。5年和10年无血栓栓塞发生率分别为97.8%和96.3%；无出血事件发生率分别为98.1%和97.6%。在医院死亡率、晚期死亡率、血栓栓塞发生率、出血事件发生率和瓣膜结构衰竭方面，SJM和CM患者组之间未发现统计学显著差异。在强化随访计划启动前，5年无血栓栓塞发生率为96.7%，之后为99.0%（p = 0.031）。相比之下，同期无出血事件发生率从99.3%降至96.1%（p = 0.0004）。