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

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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.

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Availability of data and materials

For data privacy reasons, original data not available.

Abbreviations

THV:

Transcatheter heart valve

BAV:

Bicuspid aortic valve

TAV:

Tricuspid aortic valve

TAVI:

Transcatheter aortic valve implantation

VARC-2:

Valve academic research consortium-2

MDCT:

Multi-detector computed tomography

IQR:

Interquartile range

BMI:

Body mass index

TIA:

Transient ischemic attack

LVEF:

Left ventricular ejection fraction

CV:

Calcium volume

CI:

Confidence interval

NYHA:

New York heart association

BVT:

Bioprosthetic valve thrombosis

SAVR:

Surgical aortic valve replacement

RIFLE:

Risk, injury, failure, loss of kidney function, and end-stage kidney disease

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Funding

This study did not receive external funding.

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Author notes

  1. Jonathan M. Michel and Antonio H. Frangieh equal contribution first authors.

Authors and Affiliations

  1. German Heart Centre Munich, Technical University Munich, Munich, Germany

    Jonathan M. Michel, Antonio H. Frangieh, Daniele Giacoppo, Hector A. Alvarez-Covarrubias, Costanza Pellegrini, Tobias Rheude, Oliver Deutsch, N. Patrick Mayr, P. Moritz Rumpf, Adnan Kastrati, Heribert Schunkert, Erion Xhepa, Michael Joner & A. Markus Kasel

  2. Department of Cardiology, University Heart Center, University Hospital Zurich, Zurich, Switzerland

    Jonathan M. Michel, P. Moritz Rumpf, Barbara E. Stähli & A. Markus Kasel

  3. Department of Cardiology, Hôtel-Dieu de France University Hospital, Saint-Joseph University of Beirut, Beirut, Lebanon

    Antonio H. Frangieh

  4. Department of Cardiology, Alto Vicentino Hospital, Santorso, Italy

    Daniele Giacoppo

  5. Department of Cardiac-Thoracic-Vascular Sciences, University of Padua, Padua, Italy

    Daniele Giacoppo

  6. Cardiovascular Research Institute, Royal College of Surgeons in Ireland, Dublin, Ireland

    Daniele Giacoppo

  7. Hospital de Cardiología, Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social, Ciudad de México, México

    Hector A. Alvarez-Covarrubias

  8. Deutsches Zentrum Für Herz- Und Kreislauf-Forschung (DZHK) E.V. (German Center for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany

    Adnan Kastrati, Heribert Schunkert & Michael Joner

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Correspondence to A. Markus Kasel.

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Conflict of interest

AHF is a proctor and medical consultant for Edwards Lifesciences. AMK is a proctor and medical consultant for and receives research support from Edwards Lifesciences. BES receives research support from Boston Scientific and Edwards Lifesciences.

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Prospective database approval provided by local ethics board (Technical University Munich).

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Patients provided consent for the procedure.

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Michel, J.M., Frangieh, A.H., Giacoppo, D. et al. Safety and efficacy of minimalist transcatheter aortic valve implantation using a new-generation balloon-expandable transcatheter heart valve in bicuspid and tricuspid aortic valves. Clin Res Cardiol 110, 1993–2006 (2021). https://doi.org/10.1007/s00392-021-01935-7

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  • DOI: https://doi.org/10.1007/s00392-021-01935-7

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