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. 2022 Jun 8:9:924958.
doi: 10.3389/fcvm.2022.924958. eCollection 2022.

10-Year Impact of Transcatheter Aortic Valve Replacement Leaflet Design (Intra- Versus Supra-Annular) in Mortality and Hemodynamic Performance

Andrea Scotti  1   2 , Luca Nai Fovino  3 , Augustin Coisne  1   2 , Tommaso Fabris  3 , Francesco Cardaioli  3 , Mauro Massussi  3 , Giulio Rodinò  3 , Alberto Barolo  3 , Mauro Boiago  3 , Saverio Continisio  3 , Carolina Montonati  3 , Tommaso Sciarretta  3 , Vittorio Zuccarelli  3 , Valentina Bernardini  3 , Giulia Masiero  3 , Massimo Napodano  3 , Chiara Fraccaro  3 , Alfredo Marchese  4 , Giovanni Esposito  5 , Juan F Granada  1   2 , Azeem Latib  1 , Sabino Iliceto  3 , Giuseppe Tarantini  3
Affiliations

10-Year Impact of Transcatheter Aortic Valve Replacement Leaflet Design (Intra- Versus Supra-Annular) in Mortality and Hemodynamic Performance

Andrea Scotti et al. Front Cardiovasc Med. .

Abstract

Background: The impact of transcatheter aortic valve replacement (TAVR) leaflet design on long-term device performance is still unknown. This study sought to compare the clinical and hemodynamic outcomes of intra- (IA) versus supra-annular (SA) TAVR designs up-to 10-years following implantation.

Methods: Consecutive patients with at least 5-years follow-up following TAVR for severe symptomatic aortic stenosis from June 2007 to December 2016 were included. Bioprosthetic valve failure (BVF) and hemodynamic valve deterioration (HVD) were defined according to VARC-3 updated definitions and estimated using cumulative incidence function to account for the competing risk of death.

Results: A total of 604 patients (82 years; 53% female) were analyzed and divided into IA (482) and SA (122) groups. Overall survival rates at 10-years were similar (IA 15%, 95%CI: 10-22; SA 11%, 95%CI: 6-20; p = 0.21). Compared to the SA TAVR, mean transaortic gradients were significantly higher and increased over time in the IA group. IA TAVRs showed higher 10-year cumulative incidences of BVF (IA 8% vs. SA 1%, p = 0.02) and severe HVD (IA 5% vs. SA 1%, p = 0.05). The occurrence of BVF and HVD in the IA group occurred primarily in the smallest TAVR devices (20-23-mm). After excluding these sizes, the cumulative incidences of BVF (IA 5% vs. SA 1%, p = 0.40) and severe HVD (IA 2% vs. SA 1%, p = 0.11) were similar.

Conclusion: In this study, TAVR leaflet design had no impact on survival at 10-years. IA devices showed higher transaortic gradients and cumulative incidences of HVD and BVF predominantly occurring in the smallest valve sizes.

Keywords: bioprosthetic valve failure; hemodynamic valve deterioration; intra-annular; supra-annular; transcatheter aortic valve replacement.

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Conflict of interest statement

GT reports honoraria for lectures/consulting from Medtronic, Edwards Lifesciences, Boston Scientific, and Abbott. AL is an advisor and reports honoraria for consulting from Medtronic, Edwards Lifesciences, Boston Scientific, and Abbott. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

FIGURE 1
FIGURE 1
Overall survival with Kaplan Meier estimates for the entire study population (A) and the comparison between intra-annular and supra-annular devices (B). TAVR, transcatheter aortic valve replacement.
FIGURE 2
FIGURE 2
Pairwise analysis of intra-annular versus supra-annular transaortic mean gradients at each follow-up time; p values were adjusted using the Bonferroni multiple testing correction method and obtained with Wilcoxon rank sum test. IQR, interquartile range; SD, standard deviation.
FIGURE 3
FIGURE 3
Cumulative incidence function of bioprosthetic valve failure (A,B) and hemodynamic valve deterioration (C,D) accounting for death as competing risk; p values are obtained with the Gray’s test and refer to the comparison between the intra-annular and the supra-annular group. BVF, bioprosthetic valve failure; HVD, hemodynamic valve deterioration.
FIGURE 4
FIGURE 4
Cumulative incidence function of bioprosthetic valve failure (A,C) and hemodynamic valve deterioration (B,D) accounting for death as competing risk; p values are obtained with the Gray’s test and refer to the comparison between IA ≤ 23 mm vs. IA > 23 mm (A,B) and IA > 23 mm vs. SA group (C,D). BVF, bioprosthetic valve failure; HVD, hemodynamic valve deterioration; IA, intra-annular; SA, supra-annular; TAVR, transcatheter aortic valve replacement.
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References

    1. Otto CM, Nishimura RA, Bonow RO, Krieger EV, Mack M, Mcleod C, et al. 2020 ACC / AHA Guideline for the management of patients with valvular heart disease. J Am Coll Cardiol. (2021) 77:e25–197. 10.1016/j.jacc.2020.11.018 - DOI - PubMed
    1. Vahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J, et al. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. (2021) 43:561–632. 10.1093/eurheartj/ehab395 - DOI - PubMed
    1. Tarantini G, Nai Fovino L. Coronary access and TAVR-in-TAVR: don’t put off until tomorrow what you can do today. JACC. (2020) 13:2539–41. 10.1016/j.jcin.2020.06.065 - DOI - PubMed
    1. Abdel-Wahab M, Landt M, Neumann FJ, Massberg S, Frerker C, Kurz T, et al. 5-Year outcomes after TAVR With Balloon-Expandable Versus Self-Expanding Valves: Results From The CHOICE randomized clinical trial. JACC. (2020) 13:1071–82. 10.1016/j.jcin.2019.12.026 - DOI - PubMed
    1. Makkar RR, Thourani VH, Mack MJ, Kodali SK, Kapadia S, Webb JG, et al. Five-year outcomes of transcatheter or surgical aortic-valve replacement. N Engl J Med. (2020) 382:799–809. 10.1056/nejmoa1910555 - DOI - PubMed

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