Jamieson W R Eric, Fradet Guy J, Abel James G, Janusz Michael T, Lichtenstein Samuel V, MacNab Joan S, Stanford Elizabeth A, Chan Florence
University of British Columbia, Vancouver, Canada.
J Thorac Cardiovasc Surg. 2009 May;137(5):1109-15.e2. doi: 10.1016/j.jtcvs.2008.07.070.
The Artificial Valve Endocarditis Reduction Trial was stopped on January 21, 2000, due to a higher incidence of paraprosthetic leak in the St Jude Medical Silzone prosthesis compared with the conventional prosthesis. The Artificial Valve Endocarditis Reduction Trial investigators reported the 2-year results in 2002. This retrospective study assessed the influence on thromboembolism and paraprosthetic leak to 7 years.
A total of 253 patients had 254 operations: 80 aortic valve replacements, 139 mitral valve replacements, and 35 multiple replacements with placement of Silzone prostheses. The mean age was 58.6 years (range 21-84 years, median age 59.8 years), and there were 126 women (49.8%) and 74 concomitant procedures (coronary artery bypass 28.9%).
Major paraprosthetic leak (repair, re-replacement, or mortality) occurred in 10 of the original procedures after 30 days (3 aortic valve replacements, 3 mitral valve replacements, 4 multiple replacements). Nine occurrences in 8 patients-5 early (<or=2 years) and 4 late (>2 years)-were managed. Seven were managed with definitive re-replacement. One was an early nonoperative fatality. There was 1 late fatality after the second late paraprosthetic leak reoperation. One of the 10 procedures occurring after 2 years had mild to moderate aortic valve replacement paraprosthetic leak managed as an incidental re-replacement at the time of correction of supra valvular patch stenosis. One additional occurrence, in addition to the 8 patients (<30 days), was considered a technical error and not related to the Silzone prosthesis and was replaced with a Silzone prosthesis. The linearized rate of paraprosthetic leak within the first 2 years of follow-up was 1.3%/patient-year and after 2 years was 0.4%/patient-year. The linearized occurrence rate for major thromboembolism was 0.42%/patient-year for aortic valve replacement and 1.71%/patient-year for mitral valve replacement.
Paraprosthetic leak with the St Jude Medical Silzone prosthesis was managed both during the early (<or=2 years) and late (>2years) intervals with re-replacement. Late managed events may be manifestations of earlier occurring paraprosthetic leak. Follow-up echocardiograms should meet standards of care, 6 to 12 months after surgery and at the slightest suspicion of dysfunction. There is no advanced continuing risk of the St Jude Medical Silzone prosthesis.
人工瓣膜心内膜炎减少试验于2000年1月21日停止，原因是与传统假体相比，圣犹达医疗Silzone假体的人工瓣膜旁漏发生率更高。人工瓣膜心内膜炎减少试验的研究人员在2002年报告了2年的结果。这项回顾性研究评估了长达7年的时间里对血栓栓塞和人工瓣膜旁漏的影响。
共有253例患者接受了254次手术：80例主动脉瓣置换术，139例二尖瓣置换术，35例多次置换并植入Silzone假体。平均年龄为58.6岁（范围21 - 84岁，中位年龄59.8岁），有126名女性（49.8%），74例有伴随手术（冠状动脉搭桥术占28.9%）。
30天后，10例初次手术出现严重人工瓣膜旁漏（修复、再次置换或死亡）（3例主动脉瓣置换术，3例二尖瓣置换术，4例多次置换）。8例患者出现9次人工瓣膜旁漏事件——5例早期（≤2年）和4例晚期（>2年）——得到处理。7例通过确定性再次置换处理。1例为早期非手术死亡。第二次晚期人工瓣膜旁漏再次手术后出现1例晚期死亡。2年后发生的10例手术中有1例出现轻度至中度主动脉瓣置换人工瓣膜旁漏，在纠正瓣上补片狭窄时作为偶然再次置换处理。除了8例患者（<30天）外，另外1例被认为是技术失误，与Silzone假体无关，用Silzone假体进行了置换。随访的前2年人工瓣膜旁漏的线性化发生率为1.3%/患者年，2年后为0.4%/患者年。主动脉瓣置换的主要血栓栓塞线性化发生率为0.42%/患者年，二尖瓣置换为1.71%/患者年。
圣犹达医疗Silzone假体的人工瓣膜旁漏在早期（≤两年）和晚期（>两年）均通过再次置换处理。晚期处理的事件可能是早期人工瓣膜旁漏的表现。术后6至12个月以及在怀疑有功能障碍时，随访超声心动图应符合护理标准。圣犹达医疗Silzone假体没有持续的晚期风险。
