Carpentier-Edwards猪生物瓣膜的五年评估

Jamieson W R, Pelletier L C, Janusz M T, Chaitman B R, Tyers F O, Miyagishima R T

J Thorac Cardiovasc Surg. 1984 Sep;88(3):324-33.

The Carpentier-Edwards porcine bioprosthesis compares favorably to other value substitutes, with a low incidence of valve-related complications after up to 6 years' follow-up. From April, 1976, to February, 1978, 397 prostheses were implanted in 355 patients at the University of British Columbia and the Montreal Heart Institute: aortic valve replacement (AVR), 155; mitral valve replacement (MVR), 154; tricuspid valve replacement (TVR), five; multiple replacement (MR), 41 patients. Previous cardiac operations had been performed in 58 patients (16.3%). Concomitant cardiac procedures, including myocardial revascularization, were performed in 66 patients (18.5%). The 30 day mortality was 8.7% (31 patients (AVR, 4.5%; MVR 9.0%; TVR 20%; MR 21.9%). The cumulative follow-up was 1,367 patient-years (range 6 to 81 months, mean 51 months). The late mortality is 3.9% per patient-year (AVR 3.4%, MVR 3.6%, MR 6.3%). The long-term valve-related complication rates (expressed as percent per patient-year and number of events) are as follows; thromboembolism (AVR 1.1 [seven], MVR 1.7 [10], MR 3.2 [four]; prosthetic valve endocarditis (AVR 0.6 [four], MVR 0.3 [two], MR 1.6 [two]); primary tissue failure (AVR 0.16 [one], MVR 1.0 [six], MR 1.6 [two]); anticoagulant-related hemorrhage 0.07 (one); and reoperation (AVR 0.48 [three], MVR 1.32 [eight], MR 2.4 [three]). Actuarial survival rates at 6 years, including operative deaths, are as follows: AVR 81.4% +/- 5.6%, MVR 70.0% +/- 6.7%, and MR 52.1% +/- 12.5%. The overall survival rate was 74.0% +/- 4.5% at 6 years. The freedom from all valve-related complications at 72 months was 83.9% +/- 4.8%. The freedom from valve-related death was 97.3% +/- 1.8% at 72 months. The freedom from valve-related death and reoperation at 72 months was 91.5% +/- 3.8%, and the freedom from reoperation alone was 93.4% +/- 3.5%. There were no deaths due to reoperation for primary tissue failure. Performance to date with the Carpentier-Edwards porcine bioprosthesis has been excellent, with an evaluation interval extending from 60 to 81 months.

与其他瓣膜替代品相比，卡朋蒂埃 - 爱德华兹猪生物瓣膜表现出色，在长达6年的随访后，瓣膜相关并发症的发生率较低。1976年4月至1978年2月，不列颠哥伦比亚大学和蒙特利尔心脏研究所为355例患者植入了397个瓣膜：主动脉瓣置换术（AVR）155例；二尖瓣置换术（MVR）154例；三尖瓣置换术（TVR）5例；多次置换术（MR）41例。58例患者（16.3%）曾接受过心脏手术。66例患者（18.5%）同时进行了包括心肌血运重建在内的心脏手术。30天死亡率为8.7%（31例患者，AVR为4.5%；MVR为9.0%；TVR为20%；MR为21.9%）。累积随访时间为1367患者年（范围6至81个月，平均51个月）。晚期死亡率为每年3.9%（AVR为3.4%，MVR为3.6%，MR为6.3%）。长期瓣膜相关并发症发生率（以每年每患者百分比和事件数表示）如下：血栓栓塞（AVR为1.1[7例]，MVR为1.7[10例]，MR为3.2[4例]）；人工瓣膜心内膜炎（AVR为0.6[4例]，MVR为0.3[2例]，MR为1.6[2例]）；原发性组织衰竭（AVR为0.16[1例]，MVR为1.0[6例]，MR为1.6[2例]）；抗凝相关出血0.07（1例）；再次手术（AVR为0.48[3例]，MVR为1.32[8例]，MR为2.4[3例]）。包括手术死亡在内，6年时的精算生存率如下：AVR为81.4%±5.6%，MVR为70.0%±6.7%，MR为52.1%±12.5%。6年时的总体生存率为74.0%±4.5%。72个月时无所有瓣膜相关并发症的发生率为83.9%±4.8%。72个月时无瓣膜相关死亡的发生率为97.3%±1.8%。72个月时无瓣膜相关死亡和再次手术的发生率为91.5%±3.8%，仅无再次手术的发生率为93.4%±3.5%。没有因原发性组织衰竭再次手术导致的死亡。迄今为止，卡朋蒂埃 - 爱德华兹猪生物瓣膜的表现优异，评估间隔时间为60至81个月。