Frater R W, Furlong P, Cosgrove D M, Okies J E, Colburn L Q, Katz A S, Lowe N L, Ryba E A
Montefiore Medical Center, Bronx, New York 10461, USA.
J Heart Valve Dis. 1998 Jan;7(1):48-53.
The study aim was to examine the long-term durability of the aortic Carpentier-Edwards Perimount pericardial bioprosthesis using actuarial and actual analyses.
A total of 267 patients were implanted at four centers between September 1981 and December 1983. Of these patients, 171 (64%) were males and 96 (36%) females; mean age at implant was 64.9+/-11.8 years (range: 21 to 86 years). Patients have been followed for 9.1+/-4.2 years (total 2335.7 patient-years). Long-term echocardiography data are presented.
The total operative (<30 days postoperative) mortality rate was 4.9%; of this, 0.4% was valve-related. The total late (> or = 30 days postoperative) mortality rate was 6.2%/pt-yr and included a valve-related mortality rate of 1.6%/pt-yr. Complications of thromboembolism, thrombosis and bleeding showed linearized rates of 1.6%/pt-yr and 0.4%/pt-yr, respectively. Valve dysfunction resulted in an explant rate of 0.9%/pt-yr and an associated mortality rate of 0.1%/pt-yr. At 14 years post implant, actuarial freedom from overall and valve-related death was 39.3% and 78.8%, respectively. Actuarial and actual freedom from valve dysfunction was 70.4% and 81.7%. Actuarial freedom from valve explant as a result of dysfunction was 85.1% in all patients; explant in patients aged < or = 65 years at implant was less (76.1%) than in patients aged >65 years (96.3%).
The high actuarial and actual freedom from explant due to structural valve dysfunction supports the long-term durability of this pericardial bioprosthesis and justifies its clinical use in patients older than 65 years at implant.
本研究旨在通过精算分析和实际分析，评估主动脉Carpentier-Edwards Perimount心包生物瓣膜的长期耐用性。
1981年9月至1983年12月期间，四个中心共植入了267例患者。其中男性171例（64%），女性96例（36%）；植入时的平均年龄为64.9±11.8岁（范围：21至86岁）。患者随访了9.1±4.2年（总计2335.7患者年）。提供了长期超声心动图数据。
手术（术后<30天）总死亡率为4.9%；其中，0.4%与瓣膜相关。晚期（术后≥30天）总死亡率为6.2%/患者年，包括瓣膜相关死亡率为1.6%/患者年。血栓栓塞、血栓形成和出血并发症的线性化发生率分别为1.6%/患者年和0.4%/患者年。瓣膜功能障碍导致的瓣膜置换率为0.9%/患者年，相关死亡率为0.1%/患者年。植入后14年，总体和瓣膜相关死亡的精算无事件生存率分别为39.3%和78.8%。瓣膜功能障碍的精算和实际无事件生存率分别为70.4%和81.7%。所有患者因功能障碍导致瓣膜置换的精算无事件生存率为85.1%；植入时年龄≤65岁患者的瓣膜置换率（76.1%）低于年龄>65岁患者（96.3%）。
由于结构性瓣膜功能障碍导致的瓣膜置换的高精算和实际无事件生存率支持了这种心包生物瓣膜的长期耐用性，并证明了其在植入时年龄大于65岁患者中的临床应用合理性。
