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Evaluating Self-Expanding Transcatheter Heart Valve Designs for Aortic Stenosis in Patients with Small Annular Dimensions: Supra- vs. Intraannular Approaches

https://doi.org/10.1007/s00392-025-02625-4

Bilal Al-Hafez (Hamburg)1, T. J. Demal (Hamburg)2, O. Bhadra (Hamburg)2, I. von der Heide (Hamburg)3, L. E. M. Hannen (Hamburg)3, D. Grundmann (Hamburg)3, L. Voigtländer-Buschmann (Hamburg)4, L. Waldschmidt (Hamburg)4, S. Blankenberg (Hamburg)3, H. Reichenspurner (Hamburg)2, N. Schofer (Hamburg)4, A. Schäfer (Hamburg)2

1Universitätsklinik Hamburg-Eppendorf Herzchirurgie Hamburg, Deutschland; 2Universitäres Herz- und Gefäßzentrum Hamburg Klinik und Poliklinik für Herz- und Gefäßchirurgie Hamburg, Deutschland; 3Universitäres Herz- und Gefäßzentrum Hamburg Klinik für Kardiologie Hamburg, Deutschland; 4Universitäres Herz- und Gefäßzentrum Hamburg Allgemeine und Interventionelle Kardiologie Hamburg, Deutschland

 

Objectives: Current evidence suggests hemodynamic superiority of supraannular self-expanding (SE) transcatheter heart valves (THV) compared to intraannular balloon-expandable (BE) THV in transcatheter aortic valve implantation (TAVI) for treatment of patients with small aortic annuli (≤23 mm). Whether this drawback of intraannular THV is due to valve position or stent design remains unclear. This non-inferiority study compares supra- and intraannular SE THV in small annuli.
 
Methods: Between 2021 and 2024 225 patients with aortic annuli <23 mm were provided with TAVI at our center. Of those, 63 patients (92.1% female, 83.2 ± 5.4 years) were treated with intraannular SE THV (study group), and 162 patients (84.0% female, 81.9 ± 6.2 years) were treated with supraannular SE THV (control group). Early clinical and hemodynamic outcomes were retrospectively evaluated in accordance with VARC-3 criteria.
 
Results: Intraannular THVs included 30.2% 23mm and 69.8% 25mm valves, whereas supraannular THVs consisted of 10.5% 23mm and 89.5% 26mm valves. Multivariate analysis of variance (MANOVA) validated similar baseline characteristics of both groups (p = 0.799). MANOVA of key VARC-3 endpoints revealed no significant overall differences (p = 0.815). Welch’s t-tests demonstrated no significant differences between THV platforms for the 30 day outcomes mortality (1.6% Intraannular, study group vs. 1.9% Supraannular, control group, p = 0.236), pacemaker implantation (11.5% vs. 14.1%, p = 0.724), stroke (1.6% vs. 3.1%, p = 0.475), myocardial infarction (0.0% vs. 1.2%, p = 0.158), renal failure (6.4% vs. 8.0%, p = 0.776) and device success (96.2% vs. 91.4%, p = 0.305). Postoperative transvalvular mean pressure gradients (6.7 ± 2.9 mmHg vs. 6.4 ± 3.5 mmHg, p = 0.549), invasive post-implantation mean pressure gradients (11.9 ± 4.6 mmHg vs. 12.2 ± 6.0, p = 0.877), and paravalvular leak > mild (6.4% vs. 0.6%, p = 0.073) presented no significant differences between groups. Minor access site complications (3.2% vs. 11.7%, p = 0.012), and procedure time (55 min. vs. 72 min., p < 0.001) showed favorable results for the patients treated in the study group. 
 
Conclusion: Intraannular SE THV presented non-inferiority in TAVI for small aortic annuli compared to supraannular SE THV regarding early clinical and hemodynamic outcomes. Both groups showed excellent outcomes, with similar postoperative transvalvular gradients suggesting crucial hemodynamic benefits of the Nitinol stent design in small aortic annuli. However, the durability of these hemodynamic results requires further investigation.
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