Jamieson W R, Gerein A N, Ling H, Miyagishima R T, Janusz M T, Tyers G F
Division of Cardiovascular and Thoracic Surgery, University of British Columbia, Vancouver, Canada.
J Card Surg. 1988 Sep;3(3 Suppl):413-28. doi: 10.1111/jocs.1988.3.3s.413.
The Mitral Medical Mitroflow pericardial bioprosthesis was implanted in 99 operations (99 patients with 104 valves) between 1984 and 1987. The mean age of the patients was 62.8 years (range 28 to 94 years). The early mortality was 6.1% (including patients with concomitant procedures--coronary artery bypass and ascending aortic aneurysm resection). Late mortality was 2.3% per patient-year. The total cumulative follow-up was 172 years. Thromboembolism (TE) was 4.1% per patient-year (fatal 1.2% per patient-year) (minor 2.3%; major 1.8%); antithromboembolic therapy-related hemorrhage (ATH) 0.6% (fatal 0.6%); prosthetic valve endocarditis (PVE) 0.6% (fatal 0%); periprosthetic leak (PPL) 0.6% (fatal 0%); clinical valve dysfunction (CVD) 1.2% (fatal 0%); and structural valve deterioration/primary tissue failure (SVD) 1.2% per patient-year (fatal 0% per patient-year). Thromboembolism was the significant complication. SVD occurred in two patients during the third year of evaluation. The overall patient survival was 89.2 +/- 3.3% at four years. The patients were classified as 91.9% NYHA functional Class III and IV preoperatively and 97.7% Class I and II postoperatively. The freedom at four years from TE was 88.5% +/- 4.9%; SVD 92.5 +/- 5.1%; and reoperation 89.8% +/- 5.3%. Freedom from all valve-related complications at four years was 76.8% +/- 6.6%; valve-related mortality 97.2 +/- 2.0%; mortality and reoperation (valve failure) 87.3% +/- 5.5%; mortality and residual morbidity (treatment failure) 95.5% +/- 2.6%; and mortality, residual morbidity, and reoperation (valve failure and dysfunction) 85.6% +/- 5.7%. There were three valve-related deaths of a total of ten deaths (early 2; late 1) (TE 2; ATH 1; CVD 0; PVE 0; PPL 0; and SVD 0). Valve-related reoperation was performed in four patients (TE 0; CVD 0; PVE 1; PPL 1; and SVD 2). The Mitral Medical Mitroflow pericardial bioprosthesis has provided very satisfactory clinical performance and afforded patients excellent quality of life.
1984年至1987年间，99例手术（99例患者，共植入104枚瓣膜）中植入了二尖瓣医疗公司的Mitroflow心包生物瓣。患者的平均年龄为62.8岁（范围28至94岁）。早期死亡率为6.1%（包括接受同期手术——冠状动脉搭桥和升主动脉瘤切除术的患者）。晚期死亡率为每年2.3%。总累积随访时间为172年。血栓栓塞（TE）发生率为每年4.1%（致命性为每年1.2%）（轻微2.3%；严重1.8%）；抗血栓栓塞治疗相关出血（ATH）0.6%（致命性0.6%）；人工瓣膜心内膜炎（PVE）0.6%（致命性0%）；瓣周漏（PPL）0.6%（致命性0%）；临床瓣膜功能障碍（CVD）1.2%（致命性0%）；以及结构瓣膜退变/原发性组织衰竭（SVD）每年1.2%（致命性每年0%）。血栓栓塞是主要并发症。在评估的第三年，有两名患者发生了SVD。四年时总体患者生存率为89.2±3.3%。术前患者91.9%为纽约心脏协会（NYHA）功能分级III级和IV级，术后97.7%为I级和II级。四年时无TE的自由度为88.5±4.9%；无SVD为92.5±5.1%；再次手术为89.8±5.3%。四年时无所有瓣膜相关并发症的自由度为76.8±6.6%；瓣膜相关死亡率为97.2±2.0%；死亡率和再次手术（瓣膜衰竭）为87.3±5.5%；死亡率和残余发病率（治疗失败）为95.5±2.6%；死亡率、残余发病率和再次手术（瓣膜衰竭和功能障碍）为85.6±5.7%。在总共十例死亡病例中有三例与瓣膜相关（早期2例；晚期1例）（TE 2例；ATH 1例；CVD 0例；PVE 0例；PPL 0例；SVD 0例）。四名患者进行了瓣膜相关再次手术（TE 0例；CVD 0例；PVE 1例；PPL 1例；SVD 2例）。二尖瓣医疗公司的Mitroflow心包生物瓣提供了非常令人满意的临床表现，并为患者带来了卓越的生活质量。
