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

• Published in: Clinical research in cardiology Vol. 110; no. 12; pp. 1993 - 2006
• Main Authors: Michel, Jonathan M., Frangieh, Antonio H., Giacoppo, Daniele, Alvarez-Covarrubias, Hector A., Pellegrini, Costanza, Rheude, Tobias, Deutsch, Oliver, Mayr, N. Patrick, Rumpf, P. Moritz, Stähli, Barbara E., Kastrati, Adnan, Schunkert, Heribert, Xhepa, Erion, Joner, Michael, Kasel, A. Markus
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Springer Berlin Heidelberg 01.12.2021; Springer Nature B.V
• Subjects: Aged; Aged, 80 and over; Aorta; Aortic stenosis; Aortic valve; Aortic Valve - surgery; Aortic Valve Stenosis - diagnosis; Aortic Valve Stenosis - surgery; Balloon treatment; Calcification; Cardiology; Complications; Computed tomography; Confidence intervals; Congestive heart failure; Female; Follow-Up Studies; Heart Valve Prosthesis; Heart valves; Humans; Implantation; Male; Medicine; Medicine & Public Health; Mortality; Multidetector Computed Tomography - methods; Original Paper; Prosthesis Design; Retrospective Studies; Safety; Thromboembolism; Thrombosis; Time Factors; Transcatheter Aortic Valve Replacement - methods; Treatment Outcome; Tricuspid Valve - surgery; Transcatheter aortic valve implantation; Aortic stenosis; Balloon-expandable; Tricuspid; Bicuspid
• ISSN: 1861-0684; 1861-0692
• DOI: 10.1007/s00392-021-01935-7

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 1308mm 3 , TAV 848mm 3 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. Graphic abstract