D'Onofrio Augusto, Cibin Giorgia, Tessari Chiara, Lorenzoni Giulia, Luzi Giampaolo, Manzan Erica, Gregori Dario, Gerosa Gino
Division of Cardiac Surgery, University of Padova, Padova, Italy.
Division of Cardiac Surgery, University of Rome "Tor Vergata", Policlinico Tor Vergata, Viale Oxford 81, 00133, Roma, Italy.
Int J Cardiol Heart Vasc. 2024 Aug 22;54:101487. doi: 10.1016/j.ijcha.2024.101487. eCollection 2024 Oct.
Conventional stented, rapid deployment and new-generation stented valves are now available for surgical aortic valve replacement (SAVR). New-generation devices feature advanced tissue treatment for theoretical prolonged durability and a new stent design able to expand in case of future transcatheter Valve-in-Valve. Aim of this retrospective, multicenter, propensity-weighted study was to compare early clinical and hemodynamic outcomes of these three different bioprostheses.
We analyzed data of 2589 patients from two national multicenter registries and one Institutional database. Study devices were Magna Ease, Intuity/Intuity Elite and Inspiris Resilia (Edwards Lifesciences, Irvine, CA, USA) and were implanted in 296 (11.4 %), 1688 (65.2 %) and 605 (23.4 %) patients, respectively. A propensity score weighting approach was employed.
In isolated SAVR, aortic cross clamp (ACC) time was shorter for Intuity (Magna Ease: 87, Intuity: 55, Inspiris: 70 min; Magna Ease vs. Intuity: p < 0.001; Inspiris vs. Intuity: p < 0.001). Overall mortality was 2 %, 1.7 % and 0.5 % in Magna Ease, Intuity and Inspiris groups, respectively (Magna Ease vs. Intuity: p = 0.476; Inspiris vs. Intuity: p = 0.395); permanent pace-maker implantation rate was lower for Inspiris (Magna Ease: 6 %, Intuity: 6 %, Inspiris: 2 %; Magna Ease vs. Intuity: p = 0.679; Inspiris vs. Intuity: p < 0.001). Median mean gradients were 13, 10 and 10 mmHg for Magna Ease, Intuity and Inspiris, respectively (Magna Ease vs. Intuity: p < 0.001; Inspiris vs. Intuity: p = 0.13).
All study devices provide excellent early clinical and hemodynamic outcomes. Inspiris shows low rates of permanent pace-maker implantation and its transaortic gradients are similar to rapid-deployment valves and lower than Magna Ease.
目前,传统带支架、快速部署型和新一代带支架瓣膜均可用于外科主动脉瓣置换术(SAVR)。新一代装置具有先进的组织处理技术,理论上可延长耐用性,并且采用了新型支架设计,能够在未来经导管瓣中瓣手术时进行扩张。这项回顾性、多中心、倾向评分加权研究的目的是比较这三种不同生物假体的早期临床和血流动力学结果。
我们分析了来自两个国家多中心登记处和一个机构数据库的2589例患者的数据。研究使用的装置为Magna Ease、Intuity/Intuity Elite和Inspiris Resilia(美国加利福尼亚州欧文市爱德华兹生命科学公司),分别植入了296例(11.4%)、1688例(65.2%)和605例(23.4%)患者。采用倾向评分加权方法。
在单纯SAVR中,Intuity的主动脉交叉钳夹(ACC)时间较短(Magna Ease:87分钟,Intuity:55分钟,Inspiris:70分钟;Magna Ease与Intuity比较:p<0.001;Inspiris与Intuity比较:p<0.001)。Magna Ease、Intuity和Inspiris组的总体死亡率分别为2%、1.7%和0.5%(Magna Ease与Intuity比较:p = 0.476;Inspiris与Intuity比较:p = 0.395);Inspiris的永久起搏器植入率较低(Magna Ease:6%,Intuity:6%,Inspiris:2%;Magna Ease与Intuity比较:p = 0.679;Inspiris与Intuity比较:p<0.001)。Magna Ease、Intuity和Inspiris的平均梯度中位数分别为13 mmHg、10 mmHg和10 mmHg(Magna Ease与Intuity比较:p<0.001;Inspiris与Intuity比较:p = 0.13)。
所有研究装置均能提供出色的早期临床和血流动力学结果。Inspiris的永久起搏器植入率较低,其跨主动脉梯度与快速部署瓣膜相似,且低于Magna Ease。