Background:This study retrospectively evaluated the long-term patient outcomes and durability of the Mosaic aortic porcine bioprosthesis in the Japan Mosaic valve long-term multicenter study.

Methods and Results:We reviewed the records of 1,202 patients who underwent aortic valve replacement with the Mosaic bioprosthesis at 10 centers in Japan (1999–2014). Patient data were collected using Research Electronic Data Capture. Patient survival was determined by Kaplan-Meier methodology. Freedom from structural valve deterioration (SVD) and valve-related reoperation and death were determined by actuarial methods. The median (interquartile range [IQR]) age of the cohort was 76 (70–80) years. The median (IQR) follow-up period was 3.52 (1.71–5.35) years. The longest follow-up was 15.8 years. The 30-day mortality rate was 2.3%. The 12-year actuarial survival rate was 59.9±7.5%, and the freedom from valve-related death was 81.1±7.9%. The freedom from reoperation was 86.4±2.6% at 12 years. The freedom from SVD at 12 years was 93.5±2.9% for patients aged ≥65 years and 98.2±1.8% for those aged <65 years. The median (IQR) systolic pressure gradient was 17 (12–23) and 19 (12–25) mmHg at 1 and 10 years, respectively. The median (IQR) effective orifice area was 1.2 (1.1–1.5) and 1.1 (1–1.5) cm²at 1 and 10 years, respectively.

Conclusions:The Mosaic porcine bioprosthesis showed satisfactory long-term outcomes over 12 years.

背景：这项研究回顾性评估了日本Mosaic瓣膜长期多中心研究中Mosaic主动脉猪生物假体的长期患者结果和耐久性。

方法和结果：我们回顾了在日本的10个中心（1999-2014年）对1202例行镶嵌生物假体置换主动脉瓣置换术的患者的记录。使用研究电子数据捕获收集患者数据。患者生存率通过Kaplan-Meier方法确定。通过精算方法确定是否存在结构性瓣膜退化（SVD）和与瓣膜相关的再次手术和死亡。该队列的中位年龄（四分位间距[IQR]）为76（70-80）岁。中位（IQR）随访期为3.52（1.71-5.35）年。最长的随访时间为15.8年。30天死亡率为2.3％。12年的精算生存率为59.9±7.5％，无瓣膜相关死亡的自由度为81.1±7.9％。12年时再次手术的自由度为86.4±2.6％。在12年时，SVD的自由度为93.5±2。≥65岁的患者为9％，<65岁的患者为98.2±1.8％。在1年和10年时，收缩压中值梯度（IQR）分别为17（12-23）和19（12-25）mmHg。中位数（IQR）有效孔口面积为1.2（1.1-1.5）和1.1（1-1.5）厘米²在1年和10年，分别。

结论：马赛克猪生物假体在12年内显示出令人满意的长期结果。