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.