Rajab Taufiek K, Ali Jason M, Hernández-Sánchez Jules, Mackie Jennifer, Grimaudo Vincenzo, Sinichino Silvia, Mills Christine, Rana Bushra, Dunning John, Abu-Omar Yasir
Department of Cardiac Surgery, Papworth Hospital NHS Foundation Trust, Cambridge, UK.
Papworth Trial Unit Collaboration, Papworth Hospital, Cambridge, UK.
J Cardiothorac Surg. 2020 Aug 3;15(1):209. doi: 10.1186/s13019-020-01248-2.
Approximately 250,000 heart valve operations are performed annually worldwide. An intensive research and development effort has led to progressively more advanced heart valve prostheses. The Carpentier-Edwards Perimount Magna Ease (CEPME) prosthesis represents the latest iteration of the Edwards Perimount series of aortic tissue valves. The current study aims to evaluate the midterm performance of this bioprosthesis.
Five hundred and eighteen patients with aortic stenosis underwent aortic valve replacement with the CEPME valve at Papworth Hospital between August 2008 and November 2011. After a minimum of 3 years from the index operation, eligible patients were retrospectively and consecutively recruited to participate. Recruitment was closed after 100 eligible patients had completed all study assessments. Investigations at follow-up included echocardiography, and NYHA status. Primary endpoints included valve performance measures.
The mean age was 72 years, 64% were male and median follow-up was 5.1 years. NYHA status had improved in 66% of patients. The average postoperative peak and mean pressure gradients decreased by 51.2 mmHg (64.5%) and 31.8 mmHg (59.4%), with a significant improvement in NYHA status. The frequency of moderate aortic regurgitation was 3%. There was no evidence for structural valve deterioration.
The CEPME has excellent mid-term durability. Its use effectively improves haemodynamics and functional capacity.
全球每年约进行25万例心脏瓣膜手术。经过大量的研发努力，心脏瓣膜假体已逐渐发展得更为先进。Carpentier-Edwards Perimount Magna Ease（CEPME）假体是Edwards Perimount系列主动脉组织瓣膜的最新一代产品。本研究旨在评估这种生物假体的中期性能。
2008年8月至2011年11月期间，518例主动脉狭窄患者在帕普沃思医院接受了CEPME瓣膜主动脉瓣置换术。在首次手术至少3年后，符合条件的患者被连续纳入研究。在100例符合条件的患者完成所有研究评估后，招募工作结束。随访调查包括超声心动图检查和纽约心脏协会（NYHA）心功能分级。主要终点包括瓣膜性能指标。
患者平均年龄72岁，男性占64%，中位随访时间为5.1年。66%的患者NYHA心功能分级有所改善。术后平均峰值压力阶差和平均压力阶差分别下降了51.2 mmHg（64.5%）和31.8 mmHg（59.4%），NYHA心功能分级有显著改善。中度主动脉瓣反流的发生率为3%。没有证据表明存在瓣膜结构退化。
CEPME具有出色的中期耐久性。其应用有效地改善了血流动力学和功能能力。
