Department of Cardiovascular Surgery, Hyogo Brain and Heart Center at Himeji, Himeji, Japan.
Interact Cardiovasc Thorac Surg. 2022 Jul 9;35(2). doi: 10.1093/icvts/ivac146.
This study aimed to examine very-long-term outcomes of a mechanical valve at the mitral position.
This study included all patients who underwent mitral valve replacement (MVR) using a mechanical valve including urgent operation at the Department of Cardiovascular Surgery, Hyogo Brain and Heart Center, Himeji, from January 1987 to December 2015.
Five hundred and eighty-three patients (277 men [47.51%]; age, 61 [54-67] years) were included in this study. The implanted valve models were as follows: SJM, 221 (37.91%); ATS, 35 (6.00%); On-X, 68 (11.66%); and Carbomedics 194, (33.28%).The median clinical follow-up duration was 13.3 (7.4-19.6) years. The survival rates at 10, 15, 20 and 25 years were 81.42%, 69.27%, 56.34% and 45.03%, respectively. Thromboembolism was observed in 38 patients, and the linearized ratio for each event was 0.626%/patient-year [95% confidence interval (CI), 0.443-0.859%]. Intracranial haemorrhage and gastrointestinal bleeding were observed in 26 and 9 patients, and the linearized ratio for each event was 0.425%/patient-year (95% CI, 0.277-0.006%) and 0.145%/patient-year (95% CI, 0.067-0.276%), respectively. Major paravalvular leak was observed in 32 patients, and the linearized ratio was 0.532%/patient-year (95% CI, 0.364%-0.751%). The cumulative incidence rate of major paravalvular leak at 10, 15, 20 and 25 years was 3.7%, 5.6%, 6.4% and 10.4%, respectively. Multivariable Cox regression analysis revealed that repeated MVR and male gender were associated with major paravalvular leak.
Male gender and repeated MVR were risk factors for paravalvular leak after mechanical MVR. Paravalvular leak could have occurred regardless of postoperative period even at 25 years after implantation. Lifelong clinical follow-up is considered necessary.
本研究旨在探讨二尖瓣机械瓣的长期疗效。
本研究纳入了 1987 年 1 月至 2015 年 12 月期间，兵库县姬路市兵库脑心中心心血管外科因紧急手术而接受二尖瓣置换术（MVR）并使用机械瓣的所有患者。
本研究共纳入 583 例患者（男 277 例[47.51%]；年龄 61[54-67]岁）。植入的瓣膜模型如下：SJM221 例（37.91%）；ATS35 例（6.00%）；On-X68 例（11.66%）；Carbomedics194 例（33.28%）。中位临床随访时间为 13.3（7.4-19.6）年。10、15、20 和 25 年的生存率分别为 81.42%、69.27%、56.34%和 45.03%。38 例患者发生血栓栓塞，每个事件的线性化比率为 0.626%/患者年[95%可信区间（CI）：0.443-0.859%]。26 例和 9 例患者分别发生颅内出血和胃肠道出血，每个事件的线性化比率分别为 0.425%/患者年（95%CI：0.277-0.006%）和 0.145%/患者年（95%CI：0.067-0.276%）。32 例患者发生严重瓣周漏，线性化比率为 0.532%/患者年（95%CI：0.364%-0.751%）。10、15、20 和 25 年时严重瓣周漏的累积发生率分别为 3.7%、5.6%、6.4%和 10.4%。多变量 Cox 回归分析显示，重复 MVR 和男性是机械 MVR 后瓣周漏的危险因素。瓣周漏可发生于术后任何时期，甚至在植入后 25 年。需要终身临床随访。
