Del Rizzo D F, Goldman B S, David T E
Toronto Hospital, Ontario.
Can J Cardiol. 1995 Jul-Aug;11(7):597-603.
To evaluate the clinical and hemodynamic performance of a new bioprosthesis for replacement of the aortic valve in humans.
In a multicentre clinical trial between July 1991 and January 1994, 118 patients underwent aortic valve replacement with the Toronto SPV valve.
Valvular pathology was aortic stenosis in 58%, insufficiency in 12% and mixed valvular disease in 30%; congenital bicuspid aortic valve was seen in 42% while heavy calcification was present in 86%. In approximately a third of the patients, concomitant coronary artery bypass surgery was performed. The mean period of aortic occlusion was 89 mins (range 48 to 180). Valve sizes implanted were: 22 mm (1%), 23 mm (7.6%), 25 mm (22.9%), 27 mm (37.3%) or 29 mm (31.4%). There were three deaths in the series: two from subacute bacterial endocarditis and one suicide. Early complications were cardiac arrest (0.8%), thromboembolism (2.5%) and arrhythmia (12.7%), while late complications were cardiac arrest (0.8%), arrhythmia (4.7%), angina (0.8%), thromboembolism (4.4%), endocarditis (1.7%) and other sepsis (0.8%). There were no valve related failures in 119 valve-years (mean follow-up 1.01 valve-year per patient). Follow-up echocardiography demonstrated an average decrease in mean systolic gradient of 36% from early to late postoperative period (P < 0.001) and an average increase in effective orifice area of 35% (P < 0.001) in the same period. No regurgitation was noted in 91% of patients at early, and 89% of patients at late, follow-up.
The Toronto SPV valve offers excellent hemodynamics, is relatively easy to insert and has few valve related complications. The observed changes in transvalvular area over time are consistent with a hypothesis that the ventricle undergoes remodelling following aortic valve replacement with this bioprosthesis. Longer follow-up is required to determine durability.
评估一种用于人体主动脉瓣置换的新型生物假体的临床和血流动力学性能。
在1991年7月至1994年1月的一项多中心临床试验中，118例患者接受了用多伦多SPV瓣膜进行的主动脉瓣置换术。
瓣膜病变为主动脉狭窄的占58%，关闭不全的占12%，混合性瓣膜病的占30%；42%的患者有先天性二叶主动脉瓣，86%的患者有重度钙化。约三分之一的患者同时进行了冠状动脉搭桥手术。主动脉阻断的平均时间为89分钟（范围48至180分钟）。植入的瓣膜尺寸为：22毫米（1%）、23毫米（7.6%）、25毫米（22.9%）、27毫米（37.3%）或29毫米（31.4%）。该系列中有3例死亡：2例死于亚急性细菌性心内膜炎，1例自杀。早期并发症有心搏骤停（0.8%）、血栓栓塞（2.5%）和心律失常（12.7%），而晚期并发症有心搏骤停（0.8%）、心律失常（4.7%）、心绞痛（0.8%）、血栓栓塞（4.4%）、心内膜炎（1.7%）和其他脓毒症（0.8%）。在119个瓣膜年（平均每位患者随访1.01个瓣膜年）中没有瓣膜相关故障。随访超声心动图显示，术后早期至晚期平均收缩期压差平均下降36%（P<0.001），同期有效瓣口面积平均增加35%（P<0.001）。早期随访时91%的患者未发现反流，晚期随访时89%的患者未发现反流。
多伦多SPV瓣膜具有优异的血流动力学性能，相对易于植入，且瓣膜相关并发症较少。观察到的跨瓣面积随时间的变化与这样一种假设一致，即使用这种生物假体进行主动脉瓣置换后心室会发生重塑。需要更长时间的随访来确定其耐久性。
