Fiane A E, Geiran O R, Svennevig J L
Department of Surgery A, Rikshospitalet, University of Oslo, Norway.
Ann Thorac Surg. 1998 Aug;66(2):443-8. doi: 10.1016/s0003-4975(98)00443-3.
The aim of the study was to evaluate our clinical experience with the CarboMedics Heart Valve Prosthesis.
Nine hundred ninety-seven consecutive patients underwent mechanical valve implantation (aortic, 771; mitral, 169; double, 52; tricuspid, 5) with this prosthesis from September 1987 through December 1993. The mean age was 62.3+/-13.7 years (range, 0.4 to 84 years); 56.6% (564 patients) were men. Four hundred seventy patients (47.1%) underwent additional surgical procedures. Mean follow-up was 4.1+/-2.2 years (range, 0 to 8.3 years) with a total of 4,040 patient-years.
Early mortality was 5.0% (50/997; aortic, 4.4%; mitral, 6.4%; double, 9.6%). Late mortality was 14.8% (140/947). Survival at 7 years was 75.9%+/-1.8% (aortic, 78.4%+/-2%; mitral, 70.7%+/-4.5%; double, 60.8%+/-7.4%). When matched for sex and age and compared with the normal Norwegian population, our patients had an increased standard mortality ratio in both men (1.9+/-0.4) and women (2.9+/-0.6). The linearized rate of major thromboembolism was 0.9% per patient-year, valve thrombosis 0.2% per patient-year, major bleeding event 0.6% per patient-year, paravalvular leak needing reoperation 0.5% per patient-year, prosthetic valve endocarditis 0.1% per patient-year, and of all reoperations 0.6% per patient-year.
The CarboMedics Heart Valve Prosthesis has incidences of morbid events comparable with or better than reported for other mechanical valves.
本研究旨在评估我们使用卡波美迪克斯心脏瓣膜假体的临床经验。
1987年9月至1993年12月，997例连续患者接受了该假体的机械瓣膜植入术（主动脉瓣，771例；二尖瓣，169例；双瓣，52例；三尖瓣，5例）。平均年龄为62.3±13.7岁（范围0.4至84岁）；56.6%（564例患者）为男性。470例患者（47.1%）接受了额外的外科手术。平均随访时间为4.1±2.2年（范围0至8.3年），总患者年数为4040。
早期死亡率为5.0%（50/997；主动脉瓣，4.4%；二尖瓣，6.4%；双瓣，9.6%）。晚期死亡率为14.8%（140/947）。7年生存率为75.9%±1.8%（主动脉瓣，78.4%±2%；二尖瓣，70.7%±4.5%；双瓣，60.8%±7.4%）。与挪威正常人群按性别和年龄匹配后比较，我们的患者男性（1.9±0.4）和女性（2.9±0.6）的标准死亡率均升高。主要血栓栓塞的线性化发生率为每年0.9%/患者，瓣膜血栓形成每年0.2%/患者，主要出血事件每年0.6%/患者，需要再次手术的瓣周漏每年0.5%/患者，人工瓣膜心内膜炎每年0.1%/患者，所有再次手术每年0.6%/患者。
卡波美迪克斯心脏瓣膜假体的不良事件发生率与其他机械瓣膜报道的相当或更好。
