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Comparative Study
. 2021 Dec;110(12):1993-2006.
doi: 10.1007/s00392-021-01935-7. Epub 2021 Sep 9.

Safety and efficacy of minimalist transcatheter aortic valve implantation using a new-generation balloon-expandable transcatheter heart valve in bicuspid and tricuspid aortic valves

Jonathan M Michel #  1   2 , Antonio H Frangieh #  1   3 , Daniele Giacoppo  1   4   5   6 , Hector A Alvarez-Covarrubias  1   7 , Costanza Pellegrini  1 , Tobias Rheude  1 , Oliver Deutsch  1 , N Patrick Mayr  1 , P Moritz Rumpf  1   2 , Barbara E Stähli  2 , Adnan Kastrati  1   8 , Heribert Schunkert  1   8 , Erion Xhepa  1 , Michael Joner  1   8 , A Markus Kasel  9   10
Affiliations
Comparative Study

Safety and efficacy of minimalist transcatheter aortic valve implantation using a new-generation balloon-expandable transcatheter heart valve in bicuspid and tricuspid aortic valves

Jonathan M Michel et al. Clin Res Cardiol. 2021 Dec.

Abstract

Background: Bicuspid aortic valve may be associated with increased complications during transcatheter aortic valve implantation (TAVI).

Aims: Compare balloon-expandable transcatheter heart valve (THV) safety and efficacy in severe tricuspid (TAV) and bicuspid (BAV) aortic stenosis.

Methods: Transfemoral TAVI was performed in 743 patients (Jan 2014-June 2019) using the SAPIEN 3 THV. Aortic valve morphology was determined using computed tomography. Valve Academic Research Consortium-2 (VARC-2) derived safety and efficacy endpoints at 1 year were evaluated.

Results: BAV patients (n = 78), were younger (77 [72, 81] vs. 81 [78, 85] years, p < 0.001) with lower surgical risk (EuroSCORE II 2.96% vs. 4.51% p < 0.001). Bicuspid valves were more calcified (BAV 1308mm3, TAV 848mm3 p < 0.001) with more asymmetric calcification (BAV 63/78 (81%), TAV 239/665 (36%), p < 0.001). Device success (BAV 94%, TAV 90%, p = 0.45) and major vascular complications (BAV 6%, TAV 9%, p = 0.66) were comparable. At 1 year, there was a trend toward lower combined all-cause mortality and rehospitalization for congestive heart failure in BAV patients (BAV 7%, TAV 13%, p = 0.08) with significantly lower all-cause mortality in this cohort (BAV 1%, TAV 9%, p = 0.020). VARC-2 time-related valve safety (BAV 22%, TAV 20%, p = 0.60) was comparable; however, bioprosthetic valve thrombosis remained more common in BAV patients (BAV 7%, TAV 2%, p = 0.010, Hazard ratio 3.57 [95% confidence interval 1.26, 10.10]). After propensity score matching, only bioprosthetic valve thrombosis remained significantly different.

Conclusions: Safety and efficacy of the SAPIEN 3 balloon-expandable THV in BAV is comparable with TAV. Higher rates of bioprosthetic valve thrombosis require further investigation.

Keywords: Aortic stenosis; Balloon-expandable; Bicuspid; Transcatheter aortic valve implantation; Tricuspid.

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