Anselmi Amedeo, Aymami Marie, Tomasi Jacques, D'Alessandro Gemma, Langanay Thierry, Corbineau Hervé, Mancini Julien, Flecher Erwan, Verhoye Jean-Philippe
Division of Thoracic and Cardiovascular Surgery, Pontchaillou University Hospital, Rennes, France.
Univ Rennes, CHU Rennes, Inserm, LTSI-UMR 1099, Rennes, France.
Eur J Cardiothorac Surg. 2024 Feb 1;65(2). doi: 10.1093/ejcts/ezad351.
The population of candidates to surgical aortic valve replacement (SAVR) is evolving. The Perimount Magna Ease© bioprosthesis has been introduced relatively recently in the practice. We aimed at evaluating its long-term results.
This article describes a single-centre cohort of 1016 consecutive SAVRs with the Magna Ease© valve (2008-2014), consisting of an all-comers population. We performed a prospective collection of in-hospital data, systematic clinical and echocardiographic follow-up. Valve-related events were as follows: structural valve deterioration (SVD; according to modified definition criteria), nonstructural valve dysfunction, patient-prosthesis mismatch (PPM).
Age at SAVR was 73.4 ± 9.5 years; calcified aortic stenosis was the indication to surgery in 59.6%. A total of 974 patients entered the follow-up; 564 were alive at the last follow-up (median duration: 9.8 years) (up to 13.4 years). New York Heart Association class was I or II in 92.1%. Overall survival at 10 years was 56.8 ± 1.8%. Freedom from SVD at 10 was 96.5 ± 0.8% (Kaplan-Meier) and 97.4 ± 0.6% (competing risks) (28 SVD events after 6.9 ± 3.3 years). There were 15 reinterventions for SVD (redo-SAVR and Transcatheter Aortic Valve Implantation (TAVI)); 10-year freedom from reintervention was 97.8 ± 0.6%. Moderate and severe PPM occurred in 26.8% and 5.4%, respectively, without association with late mortality (P = 0.12 for moderate and P = 0.70 for severe PPM). Freedom from valve-related mortality was 97.8 ± 0.5% at 10 years.
In this follow-up of the Magna Ease bioprosthesis for SAVR, data indicate good late outcomes (30-day outcomes are excluded). Continued follow-up is required to further support its use in patients with life expectancy >10-12 years.
接受外科主动脉瓣置换术（SAVR）的患者群体在不断变化。Perimount Magna Ease©生物假体最近才开始应用于临床实践。我们旨在评估其长期效果。
本文描述了一个单中心队列，共1016例连续接受Magna Ease©瓣膜SAVR手术的患者（2008 - 2014年），涵盖所有患者群体。我们前瞻性收集了住院数据，并进行了系统的临床和超声心动图随访。瓣膜相关事件如下：结构性瓣膜退变（SVD；根据修订的定义标准）、非结构性瓣膜功能障碍、患者 - 假体不匹配（PPM）。
SAVR手术时的年龄为73.4 ± 9.5岁；59.6%的患者手术指征为钙化性主动脉瓣狭窄。共有974例患者进入随访；在最后一次随访时，564例患者存活（中位随访时间：9.8年）（最长达13.4年）。纽约心脏协会心功能分级为I级或II级的患者占92.1%。10年总生存率为56.8 ± 1.8%。10年时无SVD的发生率为96.5 ± 0.8%（Kaplan - Meier法）和97.4 ± 0.6%（竞争风险法）（6.9 ± 3.3年后发生28例SVD事件）。有15例因SVD进行了再次干预（再次SAVR和经导管主动脉瓣植入术（TAVI））；10年无再次干预的发生率为97.8 ± 0.6%。中度和重度PPM的发生率分别为26.8%和5.4%，与晚期死亡率无关（中度PPM的P值为0.12，重度PPM的P值为0.70）。10年时无瓣膜相关死亡率为97.8 ± 0.5%。
在本次对Magna Ease生物假体用于SAVR的随访中，数据表明其晚期效果良好（排除30天的结果）。需要持续随访以进一步支持其在预期寿命>10 - 12年的患者中的应用。
