Department of Cardiovascular Surgery, Hyogo Prefectural Amagasaki General Medical Center, 2-17-77, Higashinaniwa-Cho, Amagasaki, Hyogo, 660-8550, Japan.
J Artif Organs. 2024 Jun;27(2):125-130. doi: 10.1007/s10047-023-01405-z. Epub 2023 Jun 8.
The St. Jude Medical Epic Supra valve is a porcine bioprosthesis designed for complete supraannular implantation. No report has shown the hemodynamic performance and clinical outcomes of aortic valve replacement with the Epic Supra valve for severe aortic stenosis in a Japanese cohort. We retrospectively evaluated 65 patients who underwent aortic valve replacement using the Epic Supra valve for aortic stenosis at our department between May, 2011 and October, 2016. The mean follow-up period was 68.7 ± 32.7 months, and the follow-up rate was 89.2%. The mean age was 76.8 ± 5.3 years. The 1-, 5-, and 8-year survival rates were 96.9%, 79.4%, and 60.3%, respectively. The rates of freedom from valve-related events were 96.6% and 81.9% at 5 and 8 years, respectively. Four patients were diagnosed with structural valve deterioration (SVD), and reintervention was performed in two patients. The rates of freedom from SVD were 98.2% and 83.3% at 5 and 8 years, respectively, and the mean time to diagnosis of SVD was 72.5 ± 25.3 months. The mean pressure gradient (MPG) was 16.8 ± 6.0 mmHg postoperatively, 17.5 ± 9.4 mmHg at 5 years, and 21.2 ± 12.4 mmHg at 8 years (p = 0.08). The effective orifice area index (EOAI) was 0.95 ± 0.2 cm2/m2 immediately after surgery, 0.96 ± 0.27 cm2/m2 at 5 years, and 0.84 ± 0.2 cm2/m2 at 8 years (p = 0.10). An increase in MPG and decrease in EOAI were also observed, which may be associated with SVD. Follow-up after 5 years is important to determine if there is an increase.
圣犹达医疗公司 Epic Supra 瓣膜是一种猪生物瓣，设计用于完全瓣上植入。目前尚无报道显示 Epic Supra 瓣膜在日本队列中用于严重主动脉瓣狭窄的主动脉瓣置换的血流动力学性能和临床结果。我们回顾性评估了 2011 年 5 月至 2016 年 10 月期间在我院因主动脉瓣狭窄接受 Epic Supra 瓣膜主动脉瓣置换术的 65 例患者。平均随访时间为 68.7±32.7 个月，随访率为 89.2%。平均年龄为 76.8±5.3 岁。1、5 和 8 年的生存率分别为 96.9%、79.4%和 60.3%。5 年和 8 年时瓣膜相关事件无复发率分别为 96.6%和 81.9%。4 例诊断为结构性瓣膜退化（SVD），其中 2 例再次介入治疗。5 年和 8 年时瓣膜无 SVD 复发率分别为 98.2%和 83.3%，SVD 的平均诊断时间为 72.5±25.3 个月。术后平均压力梯度（MPG）为 16.8±6.0mmHg，5 年时为 17.5±9.4mmHg，8 年时为 21.2±12.4mmHg（p=0.08）。术后即刻有效瓣口面积指数（EOAI）为 0.95±0.2cm2/m2，5 年时为 0.96±0.27cm2/m2，8 年时为 0.84±0.2cm2/m2（p=0.10）。MPG 升高和 EOAI 降低也观察到，这可能与 SVD 有关。5 年后的随访对于确定是否有增加是很重要的。
