Dokollari Aleksander, Torregrossa Gianluca, Sicouri Serge, Veshti Altin, Margaryan Rafik, Cameli Matteo, Mandoli Giulia Elena, Maccherini Massimo, Montesi Gianfranco, Cabrucci Francesco, Coku Lindita, Arora Rakesh, Li Qiao Ri, Bonacchi Massimo, Gelsomino Sandro
Department of Cardiothoracic Surgery Research, Lankenau Institute for Medical Research, Wynnewood, Pennsylvania, USA.
Department of Cardiothoracic Surgery, Lankenau Medical Center, Lankenau Heart Institute, Main Line Health, Wynnewood, Pennsylvania, USA.
J Card Surg. 2022 Dec;37(12):5411-5417. doi: 10.1111/jocs.17231. Epub 2022 Nov 20.
To highlight short- and long-term clinical outcomes of the Intuity TM rapid deployment prosthesis for surgical aortic valve replacement.
We reviewed on PubMed/MEDLINE, Embase, SciELO, LILACS, CCTR/CENTRAL, and Google Scholar for clinical trials, retrospective clinical studies, meta-analysis, and gray literature.
Fourty-five clinical studies with 12.714 patients were included in the analysis. Thirty-day mortality ranged from 3.8% for Intuity and 3.9% for transcatheter aortic valve replacement (TAVR). The incidence of paravalvular leak (PVL) (Intuity 0% and TAVR 2.17%), permanent pacemaker implantation (Intuity 11.11% and TAVR 12.5%), stroke (Intuity 2.2% and TAVR 2.6%), myocardial infarction (MI) (Intuity 0% and TAVR 1%), were all higher in the TAVR group. Compared to other sutured bioprosthesis (SB), mortality ranged from 0% to 3.9% for Intuity and 0%-6.9% for SB. Long-term cardiac mortality ranged from 0.9% to 1.55% for Intuity and 1.4%-3.3% for the Perceval valve. The incidence of PVL (Intuity 0.24%-0.7% and Perceval 0%-1%), endocarditis (Intuity 0.2%-0.7% and Perceval 1.6%-6.6%), stroke (Intuity 0.36%-1.4% and Perceval 0%-0.8%), MI (Intuity 0.07%-0.26%), and SVD (Intuity 0.12%-0.7% and Perceval 0%) were comparable. Compared to standard full sternotomy (SFS), minimally invasive surgery (MINV) mortality ranged from 0% to 4.3% for MINV and 0%-2.1% for SFS. Hospital costs outcomes ranged from $37,187-$44,368 for the Intuity, $69,389 for TAVR, and $13,543 for SB. Intuity short-term mortality ranged between 0.9% and 12.4% while long-term mortality ranged between 2.6% and 20%.
This manuscript provides a 360° overview of the current rapid deployments, sutureless, and TAVR prosthesis.
强调用于外科主动脉瓣置换的Intuity TM快速部署人工瓣膜的短期和长期临床结果。
我们在PubMed/MEDLINE、Embase、SciELO、LILACS、CCTR/CENTRAL和谷歌学术上检索了临床试验、回顾性临床研究、荟萃分析和灰色文献。
分析纳入了45项临床研究，共12714例患者。Intuity组30天死亡率为3.8%，经导管主动脉瓣置换术（TAVR）组为3.9%。瓣周漏（PVL）发生率（Intuity组为0%，TAVR组为2.17%）、永久起搏器植入率（Intuity组为11.11%，TAVR组为12.5%）、中风发生率（Intuity组为2.2%，TAVR组为2.6%）、心肌梗死（MI）发生率（Intuity组为0%，TAVR组为1%），均是TAVR组更高。与其他缝合生物瓣膜（SB）相比，Intuity的死亡率为0%至3.9%，SB为0%至6.9%。Intuity的长期心脏死亡率为0.9%至1.55%，Perceval瓣膜为1.4%至3.3%。PVL发生率（Intuity为0.24%至0.7%，Perceval为0%至1%）、心内膜炎发生率（Intuity为0.2%至0.7%，Perceval为1.6%至6.6%）、中风发生率（Intuity为0.36%至1.4%，Perceval为0%至0.8%）、MI发生率（Intuity为0.07%至0.26%）和结构性瓣膜衰败（SVD）发生率（Intuity为0.12%至0.7%，Perceval为0%）相当。与标准全胸骨切开术（SFS）相比，微创手术（MINV）死亡率MINV为0%至4.3%，SFS为0%至2.1%。Intuity的住院费用为37187美元至44368美元，TAVR为69389美元，SB为13543美元。Intuity的短期死亡率在0.9%至12.4%之间，长期死亡率在2.6%至20%之间。
本手稿全面概述了当前的快速部署、无缝合和TAVR人工瓣膜。
