SAVR versus TAVI: What about the Hemodynamic Performance? An In Vivo and In Vitro Analysis

Abstract

Background Surgical aortic valve replacement (SAVR) is nowadays discussed whether it remains the gold standard of treatment. In the last decade, there has been a tremendous increase in transcatheter aortic valve implantation (TAVI) due to the growing expertise and excellent results of the catheter-based approach. We, therefore, retrospectively compared the rapid deployment valve (RDV), the Edwards Intuity valve (IEV), with the Edwards Sapien 3 (S3V) with regard to post-procedural hemodynamics. Methods A total of 246 patients treated with TAVI or SAVR between February 2009 and November 2015 were included. One-hundred twenty-five patients were analyzed in the SAVR group and compared with 121 patients undergoing TAVI. Transvalvular pressure gradients (PGs) and the incidence and extent of aortic regurgitation (AR) were compared post-procedurally by echocardiography for each valve size. In vitro hemodynamics were analyzed by placing both valves into an aortic silicone phantom connected to a pulsatile flow pump and measured using phase-contrast magnetic resonance imaging (4D flow MRI). Results Post-procedurally, mean transvalvular PGs for the 23 mm valves were 9 (7;11.5) versus 13 (9;18) (p < 0.001), whereas maximum PGs were 16.5 (14;22) versus 25.5 mm Hg (17.5;34) (p < 0.001) in IEV and S3V patients, respectively. The 21 mm IEV showed significantly lower transvalvular PGs compared with the 23 mm S3V: mean PGs: 11 (8;13) versus 13 (9;18) (p < 0.05); maximum PG: 19.5 (13;24) versus 25.5 (18;34) mm Hg (p < 0.05). Analysis revealed significantly lower post-procedural transvalvular PGs for larger valves sizes. With respect to AR, the incidence of AR was significantly lower in IEV group (p < 0.05). In vitro velocities and turbulent kinetic energy values showed similar results between both valves. Conclusion Implanted RDVs presented a lower incidence of paravalvular regurgitation and were associated with significantly lower post-procedural transvalvular PGs, especially for small valve sizes. Our data might support the application of rapid deployment aortic valves in patients with small aortic annulus in the TAVI era.

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

“…After excluding duplicates and non-eligible studies (Figure 1), 45 studies with 12.714 patients were included in the analyses. Clinical studies showed that 30-day mortality ranged from 3.8% for Intuity and 3.9% for TAVR [9][10][11] (Supporting Information: Table 1). The incidence of PVL (Intuity 0% and TAVR 2.17%), PPI (Intuity 11.11% and TAVR 12.5%), stroke (Intuity 2.2% and TAVR 2.6%), MI (Intuity 0% and TAVR 1%), were all comparable among groups.…”

“…Studies were included if any of the following criteria were met: (1) reported outcomes of Intuity and other heart valve prostheses or procedures; (2) reported analysis of complications using the Intuity valve; (3) reported off‐label experience; (4) reported learning curve analysis; 5 reported analysis of MINV outcomes; 6 reported in‐hospital and follow‐up costs of the valves; 7 reported outcomes of TAVI (either transfemoral and transapical), 9 was a clinical trial, meta‐analysis, retrospective study, and gray literature.…”