Heart Center, Turku University Hospital and Department of Surgery, University of Turku, Turku, Finland; Department of Surgery, Oulu University Hospital and Research Unit of Surgery, Anesthesia and Intensive Care, University of Oulu, Oulu, Finland.
Heart Center, Kuopio University Hospital, Kuopio, Finland.
Ann Thorac Surg. 2020 Sep;110(3):879-888. doi: 10.1016/j.athoracsur.2019.12.071. Epub 2020 Feb 12.
Recent surgical bovine pericardial prostheses are widely used despite limited data on their long-term durability.
This is a comparative analysis of the outcome of the Trifecta (Abbott, Abbott Park, IL) and Perimount Magna Ease (Edwards, Lifesciences Corp, Irvine, CA) bioprostheses from the FinnValve registry, a Finnish nationwide database including patients with aortic stenosis who underwent transcatheter or surgical aortic valve replacement with a bioprosthesis between 2008 and 2017.
Overall 2216 patients (mean age, 74.1 ± 6.7 years; age <65 years, 8.9%; mean follow-up, 3.8 ± 2.1 years) received the Trifecta (851 patients) or the Perimount Magna Ease (1365 patients) bioprostheses. The rates of late mortality and prosthetic valve endocarditis were comparable in the study cohorts. At 7 years the Trifecta cohort had a significantly higher risk of repeat aortic valve replacement for structural valve failure (3.3% vs 0%; adjusted subdistribution hazard ratio, 2.224; 95% confidence interval, 1.044-4.737), repeat aortic valve replacement for any cause (3.6% vs 0.4%; adjusted subdistribution hazard ratio, 3.210; 95% confidence interval, 1.286-8.013), and repeat aortic valve replacement and/or prosthetic valve endocarditis (4.1% vs 0.9%; adjusted subdistribution hazard ratio, 3.210; 95% confidence interval, 1.286-8.013) compared with the Perimount Magna Ease cohort. Among 772 propensity score-matched pairs, at 7 years the Trifecta cohort had a higher risk of repeat aortic valve replacement for structural valve failure (5.7% vs 0%, P = .009).
The Trifecta aortic bioprosthesis is associated with a higher occurrence of repeat aortic valve replacement for structural valve failure compared with the Perimount Magna Ease bioprosthesis. Further comparative studies with echocardiographic data on structural valve deterioration and longer follow-up are needed to confirm these findings.
尽管有关其长期耐久性的数据有限,但最近的外科牛心包假体仍被广泛使用。
本研究对来自芬兰全国性登记处 FinnValve 的 Trifecta(雅培,雅培公园,IL)和 Perimount Magna Ease(爱德华兹,生命科学公司,欧文,CA)生物假体的结果进行了比较分析,该登记处包括 2008 年至 2017 年间接受经导管或外科主动脉瓣置换术的主动脉瓣狭窄患者,使用生物假体。
共有 2216 例患者(平均年龄 74.1±6.7 岁;年龄<65 岁者占 8.9%;平均随访 3.8±2.1 年)接受了 Trifecta(851 例)或 Perimount Magna Ease(1365 例)生物假体。研究队列中晚期死亡率和人工瓣膜心内膜炎的发生率相似。在 7 年时,Trifecta 组因结构性瓣膜失效而再次接受主动脉瓣置换术的风险明显更高(3.3%比 0%;调整后的亚分布风险比为 2.224;95%置信区间为 1.044-4.737),因任何原因再次接受主动脉瓣置换术的风险(3.6%比 0.4%;调整后的亚分布风险比为 3.210;95%置信区间为 1.286-8.013)和再次接受主动脉瓣置换术和/或人工瓣膜心内膜炎的风险(4.1%比 0.9%;调整后的亚分布风险比为 3.210;95%置信区间为 1.286-8.013)均高于 Perimount Magna Ease 组。在 772 对倾向评分匹配的对中,在 7 年时,Trifecta 组因结构性瓣膜失效而再次接受主动脉瓣置换术的风险更高(5.7%比 0%,P=0.009)。
与 Perimount Magna Ease 生物假体相比,Trifecta 主动脉生物假体与结构性瓣膜失效后再次发生主动脉瓣置换的发生率更高。需要进一步进行比较研究,以超声心动图数据评估结构性瓣膜恶化,并进行更长时间的随访,以证实这些发现。