Emery Robert W, Van Nooten Guido J, Tesar Peter J
Cardiac Surgical Associates, Minneapolis, Minnesota, USA.
Ann Thorac Surg. 2003 Feb;75(2):444-52. doi: 10.1016/s0003-4975(02)04537-x.
From May 1994 through October 2000, a total of 1,146 patients underwent valve replacement with the ATS Medical mechanical cardiac valve prosthesis under a study protocol approved by international ethics committees (non-United States participants) or under a United States Food and Drug Administration-approved Investigational Device Exemption study. The study took place at 19 domestic and three international centers.
As required by the Food and Drug Administration's Heart Valve Guidance Document, only isolated implants were included in the study (double-valve implants were excluded), with operative and follow-up data collected from each center.
Aortic valve replacement (AVR) was conducted in 801 patients (309 with coronary bypass) and mitral valve replacement (MVR) in 345 patients (78 with coronary bypass). Overall operative (< or = 30 days post implant) mortality was 2.1% (17 AVR = 2.1%, 7 MVR = 2.0%), 7 of which (AVR = 4, MVR = 3) were valve related. In 2,086 patient-years (1,459 AVR patient-years, 627 MVR patient-years) of follow-up, there were an additional 50 patient deaths of these, 18 were valve related, 9 due to anticoagulant related bleeding, 5 sudden/unexplained, and 1 each after stroke, thrombosis, prosthetic valve endocarditis, and thromboembolism. Late (>30 days post implant) valve-related complications included: transient and chronic thromboembolism (27 AVR (linearized rate 1.85%/patient-year) and 20 MVR (3.19%/patient-year), of which 11/47 (0.53%/patient-year) had chronic deficits, thrombosis (1 AVR = 0.07%/patient-year and 4 MVR = 0.64%/patient-year), paravalvular leak (10 AVR = 0.69%/patient-year and 8 MVR = 1.28%/patient-year), anticoagulant related hemorrhage (34 AVR = 2.33%/patient-year and 8 MVR = 1.28%/patient-year), prosthetic valve endocarditis (3 AVR = 0.21%/patient-year and 2 MVR = 0.32%/patient-year), and structural valve failure or dysfunction (0%). Echocardiographic gradients were proportional to valve size and did not significantly change over the follow-up period.
This study documented the ATS Medical mechanical cardiac valve prosthesis to be a valuable addition to the surgeon's armamentarium in the treatment of cardiac valvular disease.
从1994年5月至2000年10月，共有1146例患者在国际伦理委员会批准的研究方案（非美国参与者）或美国食品药品监督管理局批准的研究性器械豁免研究下，接受了使用ATS医疗机械心脏瓣膜假体的瓣膜置换术。该研究在19个国内中心和3个国际中心进行。
按照食品药品监督管理局心脏瓣膜指导文件的要求，该研究仅纳入孤立植入病例（排除双瓣膜植入），并从每个中心收集手术及随访数据。
801例患者接受了主动脉瓣置换术（AVR）（其中309例同时进行了冠状动脉搭桥术），345例患者接受了二尖瓣置换术（MVR）（其中78例同时进行了冠状动脉搭桥术）。总体手术（植入后≤30天）死亡率为2.1%（17例AVR = 2.1%，7例MVR = 2.0%），其中7例（AVR = 4例，MVR = 3例）与瓣膜相关。在2086患者年（1459例AVR患者年，627例MVR患者年）的随访中，又有50例患者死亡，其中18例与瓣膜相关，9例因抗凝相关出血，5例猝死/原因不明，1例分别死于中风、血栓形成、人工瓣膜心内膜炎和血栓栓塞。晚期（植入后>30天）瓣膜相关并发症包括：短暂性和慢性血栓栓塞（27例AVR（线性化发生率1.85%/患者年）和20例MVR（3.19%/患者年），其中11/47（0.53%/患者年）有慢性缺损）；血栓形成（1例AVR = 0.07%/患者年，4例MVR = 0.64%/患者年）；瓣周漏（10例AVR = 0.69%/患者年，8例MVR = 1.28%/患者年）；抗凝相关出血（34例AVR = 2.33%/患者年，8例MVR = 1.28%/患者年）；人工瓣膜心内膜炎（3例AVR = 0.21%/患者年，2例MVR = 0.32%/患者年）；以及结构性瓣膜失效或功能障碍（0%）。超声心动图梯度与瓣膜大小成正比，且在随访期间无显著变化。
本研究证明，ATS医疗机械心脏瓣膜假体是外科医生治疗心脏瓣膜疾病的宝贵工具。
