Pearls, pitfalls, and surgical indications of the Intuity TM heart valve: A rapid deployment bioprosthesis. A systematic review of the literature.

OBJECTIVES: To highlight short- and long-term clinical outcomes of the Intuity TM rapid deployment prosthesis for surgical aortic valve replacement. METHODS: We reviewed on PubMed/MEDLINE, Embase, SciELO, LILACS, CCTR/CENTRAL, and Google Scholar for clinical trials, retrospective clinical studies, meta-analysis, and gray literature. RESULTS: 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%. CONCLUSIONS: This manuscript provides a 360° overview of the current rapid deployments, sutureless, and TAVR prosthesis.

Risk predictors that impact long-term prognosis in patients undergoing aortic valve replacement with the Perceval sutureless bioprosthesis.

BACKGROUND: The aim of this study is to identify risk predictors that impact long-term prognosis in patients undergoing isolated aortic valve replacement (AVR) with Perceval sutureless bioprosthesis aortic valve implantation. METHODS: From 2013 to 2020, 101 consecutive participants who underwent isolated AVR with the Perceval sutureless bioprosthesis were included. Primary endpoint was analysis of all-cause mortality. We performed a propensity-adjusted analysis of patients undergoing redo sutureless vs redo sutured AVR to understand the impact of sutureless valves in redo operations. RESULTS: Pre-operative characteristics included a mean age of 71.2-years, mean EuroScore II of 3.51 (±4.48), mean body mass index of 30.2 (±6.8). Mean follow-up was 1.5 years. Intraoperatively, mean cardiopulmonary bypass time and aortic cross-clamp time were 65 ± 29.6 and 47.3 ± 21.3 min, respectively. Valve redeployment was necessary in 9.9 % of cases and there was one intraoperative death. There were two hospital deaths (including the operative death) while only one was cardiac related. Postoperatively, mean ejection fraction was 55.5 % (±4.1 %), mean effective orifice was 1.5 (±0.3) cm2, and mean transvalvular gradient was 14.7 (±4) mmHg. At 7-years follow-up, 87.9 % of patients were alive. Risk predictors for all-cause death were female sex and left ventricular diastolic dysfunction (LVDD) grade ≥ 2. After matching, aortic cross-clamp time, inotrope use, blood product transfusions, respiratory failure, and post-operative arrhythmias were higher in the redo sutured group compared to the sutureless redo group. CONCLUSIONS: Sutureless aortic valve implantations have good clinical outcomes. Risk predictors for all-cause death included female sex and LVDD grade ≥ 2.