Department of Cardiac Surgery, University of Michigan, Ann Arbor, Michigan.
Department of Cardiac Surgery, University of Michigan, Ann Arbor, Michigan.
Ann Thorac Surg. 2020 Mar;109(3):720-727. doi: 10.1016/j.athoracsur.2019.06.032. Epub 2019 Aug 6.
Structural valve degeneration (SVD) is a major flaw of bioprostheses. An apparent increase in the SVD rate has been observed among patients who received the Trifecta bioprosthesis (Abbott Vascular, Santa Clara, CA).
This study retrospectively reviewed 1058 consecutive patients who underwent aortic valve placement with a stented bioprosthesis between January 2011 and December 2015. Patients were grouped into a Trifecta group (508 [48.0%] patients with Trifecta bioprostheses) and a non-Trifecta group (550 [52.0%] patients with other bioprostheses).
Patients in the Trifecta group were older (69.7 years vs 64.6 years; P = .001), were more likely female (40.4% vs 28.0%; P = .001), more often had aortic stenosis (85.1% vs 77.1%; P = .001), and received smaller valves (23.0 mm vs 25.0 mm; P < .001) than patients in the non-Trifecta group. SVD occurred in 28 patients (Trifecta, n = 22; non-Trifecta, n = 6) within 7 years. Aortic regurgitation or mixed stenosis/regurgitation was observed as the mode of failure in more than 50% of the Trifecta group, whereas none in non-Trifecta group. The cumulative incidence of SVD was higher in the Trifecta group both in the entire cohort (13.3% vs 4.6%; P = .010) and in the younger cohort (age ≤ 65 years; 27.9% vs 6.9%; P = .004), with a notable increase between 5 and 7 years. Multivariable competing risks regression in the Trifecta group revealed younger age (hazard ratio, 0.56 per 10-point decrease; 95% confidence interval, 0.44 to 0.72; P < .001) to be the sole contributor to SVD.
The SVD rate of the Trifecta bioprosthesis has been greater than expected, compared with other bioprostheses, particularly in younger patients. In view of the large number of Trifecta bioprostheses implanted worldwide, further investigation involving other institutions is warranted.
结构性瓣膜退化（SVD）是生物假体的主要缺陷。接受 trifecta 生物假体（雅培血管，圣克拉拉，CA）的患者中，SVD 发生率明显增加。
本研究回顾性分析了 2011 年 1 月至 2015 年 12 月期间接受带支架生物假体主动脉瓣置换术的 1058 例连续患者。患者分为 trifecta 组（508 例[48.0%]患者使用 trifecta 生物假体）和非 trifecta 组（550 例[52.0%]患者使用其他生物假体）。
trifecta 组患者年龄较大（69.7 岁比 64.6 岁；P =.001），女性比例较高（40.4%比 28.0%；P =.001），主动脉狭窄更常见（85.1%比 77.1%；P =.001），且接受的瓣膜较小（23.0 毫米比 25.0 毫米；P <.001）。trifecta 组 28 例（trifecta 组 22 例，非 trifecta 组 6 例）在 7 年内发生 SVD。超过 50%的 trifecta 组以主动脉瓣反流或混合狭窄/反流为失效模式，而非 trifecta 组则没有。trifecta 组的 SVD 累积发生率在整个队列中（13.3%比 4.6%；P =.010）和较年轻队列中（年龄≤65 岁；27.9%比 6.9%；P =.004）均较高，在 5 至 7 年内显著增加。trifecta 组多变量竞争风险回归显示，年龄较小（每降低 10 分，风险比为 0.56；95%置信区间为 0.44 至 0.72；P <.001）是 SVD 的唯一危险因素。
与其他生物假体相比，trifecta 生物假体的 SVD 发生率一直高于预期，尤其是在年轻患者中。鉴于全球植入了大量的 trifecta 生物假体，有必要在其他机构进行进一步的调查。
