Francica Alessandra, Tonelli Filippo, Rossetti Cecilia, Galeone Antonella, Perrone Fabiola, Luciani Giovanni Battista, Onorati Francesco
Department of Surgery, Dentistry, Paediatrics, and Gynaecology, Division of Cardiac Surgery, University of Verona Medical School, 37129 Verona, Italy.
J Clin Med. 2023 Mar 6;12(5):2077. doi: 10.3390/jcm12052077.
During the past decade, the Perimount Magna Ease (PME) bioprosthesis has been implanted worldwide for aortic valve replacement (AVR). Recently, the INSPIRIS Resilia (IR) valve has been introduced as the newest generation of pericardial bioprostheses. However, few data have been reported about patients ≤70 years, and no comparisons in terms of hemodynamic performance between these two bioprostheses have been ever reported.
Patients aged <70 years undergoing AVR were considered for comparison between PME ( = 238) and IR ( = 192). Propensity score (PS) matching was performed by logistic regression with adjustment for eight key baseline variables. The two prostheses were compared in terms of hemodynamic performances up to 3 years postoperatively. Sub-analysis according to prosthetic size-category was accomplished.
A total of 122 pairs with similar baseline characteristics were obtained from the PS-matching. The two prostheses showed comparable hemodynamic performances at one year (Gmean: 11.3 ± 3.5 mmHg vs. 11.9 ± 5.4 mmHg; = 0.8) and at 3 years postoperatively (Gmean: 12.2 ± 7.9 mmHg vs. 12.8 ± 5.2 mmHg for; = 0.3). The sub-analysis of size-category confirmed no statistical differences concerning the hemodynamic performances for each annulus size.
This first PS-matched analysis demonstrated that the newly developed IR valve achieves the same safety and efficacy of the PME valve during mid-term follow-up in patients aged <70 years.
在过去十年间，Perimount Magna Ease（PME）生物瓣膜已在全球范围内用于主动脉瓣置换术（AVR）。最近，INSPIRIS Resilia（IR）瓣膜作为新一代心包生物瓣膜被引入。然而，关于70岁及以下患者的数据报道较少，且从未有过这两种生物瓣膜血流动力学性能比较的报道。
将年龄<70岁接受AVR的患者纳入PME（n = 238）和IR（n = 192）的比较研究。通过逻辑回归进行倾向评分（PS）匹配，并对八个关键基线变量进行调整。比较两种瓣膜术后3年内的血流动力学性能。根据假体尺寸类别进行亚分析。
通过PS匹配共获得122对基线特征相似的患者。两种瓣膜在术后1年（几何平均压差：11.3±3.5 mmHg vs. 11.9±5.4 mmHg；P = 0.8）和3年（几何平均压差：12.2±7.9 mmHg vs. 12.8±5.2 mmHg；P = 0.3）时的血流动力学性能相当。尺寸类别亚分析证实，各瓣环尺寸的血流动力学性能无统计学差异。
这一首次PS匹配分析表明，新研发的IR瓣膜在70岁及以下患者的中期随访中，实现了与PME瓣膜相同的安全性和有效性。
