卡彭蒂埃-爱德华兹玛格纳易生物瓣：多中心临床经验和 12 年耐久性。
Carpentier-Edwards Magna Ease bioprosthesis: a multicentre clinical experience and 12-year durability.
机构信息
Department of Cardiac-Thoracic-Vascular Sciences and Public Health, University of Padua, Padova, Italy.
Cardiac Surgery Unit, Azienda Integrata Isontina, Trieste Hospital, Trieste, Italy.
出版信息
Eur J Cardiothorac Surg. 2022 Mar 24;61(4):888-896. doi: 10.1093/ejcts/ezab552.
OBJECTIVES
The goal of this multicentre retrospective study was to compare long-term clinical and haemodynamic outcomes of the Carpentier-Edwards Magna Ease (CEME) bioprosthesis by patient age.
METHODS
We included consecutive patients who underwent isolated and combined surgical aortic valve replacement (AVR) with CEME valve between January 2008 and March 2020 at 4 cardiac surgery centres in Italy. Survival distribution was evaluated at follow-up according to age and surgery type (combined or isolated AVR), together with freedom from structural valve deterioration (SVD), reoperation and combined events, i.e. SVD, reoperation, endocarditis and thromboembolic events.
RESULTS
A total of 1027 isolated and 1121 combined AVR were included; 776 patients were younger than 65 years whereas 1372 were 65 years or older. The 30-day Valve-Academic-Research-Consortium mortality was 2% (<65 years) and 6% (≥ 65 years) (P < 0.001), whereas it was 3% for isolated AVR and 7% for combined AVR (P < 0.001). The 12-year survival was 81% for those younger than 65 years vs 45% for those equal to or older than 65 years (P < 0.001), whereas they were 61% vs 49% for isolated and combined AVR (P = 0.10). The 12-year freedom from combined events, excluding death, was 79% for those younger than 65 years vs 87% for those equal to or older than (P = 0.51), whereas they were 83% for isolated and 86% for combined AVR (P = 0.10). The 12-year freedom from SVD was 93% and 93% in patients younger than 65 and those equal to or older than 65 years (P = 0.63), and the results were comparable even in cases with isolated and combined AVR (92% vs 94%, P = 0.21). A multivariable Cox analysis including gender, presence of patient-prosthesis mismatch, isolated AVR and age showed that only the age was an independent risk factor for the incidence of SVD (P = 0.029).
CONCLUSIONS
Outcomes from this large multicentre analysis demonstrated that a CEME bioprosthesis provides good clinical results and long-term durability even in patients younger than 65 years. Furthermore, the hazard for SVD has been shown to be lower for older age.
CLINICAL TRIAL REGISTRATION NUMBER
105n/AO/21.
目的
本多中心回顾性研究的目的是比较按患者年龄分组的 Carpentier-Edwards Magna Ease（CEME）生物瓣的长期临床和血液动力学结果。
方法
我们纳入了 2008 年 1 月至 2020 年 3 月期间在意大利 4 个心脏外科中心接受单独或联合外科主动脉瓣置换术（AVR）的连续患者，并使用 CEME 瓣膜。根据年龄和手术类型（联合或单独 AVR），以及结构瓣恶化（SVD）、再次手术和合并事件（即 SVD、再次手术、心内膜炎和血栓栓塞事件）的无事件生存率，在随访时评估生存分布。
结果
共纳入 1027 例单独 AVR 和 1121 例联合 AVR；776 例患者年龄小于 65 岁，1372 例患者年龄等于或大于 65 岁。30 天 Valve-Academic-Research-Consortium 死亡率为 2%（<65 岁）和 6%（≥65 岁）（P<0.001），而单独 AVR 为 3%，联合 AVR 为 7%（P<0.001）。65 岁以下患者 12 年生存率为 81%，而 65 岁及以上患者为 45%（P<0.001），而单独 AVR 为 61%，联合 AVR 为 49%（P=0.10）。65 岁以下患者 12 年无合并事件（不包括死亡）率为 79%，65 岁及以上患者为 87%（P=0.51），而单独 AVR 为 83%，联合 AVR 为 86%（P=0.10）。65 岁以下和 65 岁及以上患者 12 年无 SVD 率分别为 93%和 93%（P=0.63），即使在单独和联合 AVR 中也有相似的结果（92%vs 94%，P=0.21）。多变量 Cox 分析包括性别、存在患者-假体不匹配、单独 AVR 和年龄，结果表明仅年龄是 SVD 发生率的独立危险因素（P=0.029）。
结论
这项来自大型多中心分析的结果表明，即使在 65 岁以下的患者中，CEME 生物瓣也能提供良好的临床结果和长期耐久性。此外，年龄较大的患者发生 SVD 的风险较低。
临床试验注册号
105n/AO/21。
Zotero 插件