Abstract
Background: Transcatheter aortic valve implantation (TAVI) in patients with small aortic annuli (SAA) is associated with an increased risk of prosthesis-patient mismatch (PPM).
Aims: This study assesses the 30-day performance of the novel, balloon-expandable DurAVR transcatheter heart valve (THV), which features a unique single-piece biomimetic leaflet design, in patients with SAA.
Methods: This pooled analysis derived from first-in-human and early feasibility studies includes all patients with SAA (defined as an aortic annular area from 346 to 452 mm2) treated with the Small size DurAVR THV. The mean computed tomography (CT)-derived aortic annulus area was 404 ± 37 mm², with an average diameter of 22.7 ± 1.0 mm. Outcomes at 30 days, including PPM, were evaluated per Valve Academic Research Consortium-3 (VARC-3) criteria, with independent adjudication of clinical events and core laboratory analysis of post-implant transthoracic echocardiograms.
Results: Amongst 100 patients (mean age 77.0 ± 7.3 years; 78% female; mean Society of Thoracic Surgeons [STS] score 4.7 ± 4.0%) treated with the DurAVR THV, the overall technical success rate was 93%. At 30 days, device success was achieved in 91% of patients, with no reported deaths and a stroke rate of 2%. Echocardiographic haemodynamic assessment showed a mean transprosthetic gradient of 8.2 ± 3.1 mmHg, a mean effective orifice area of 2.2 ± 0.3 cm², and a doppler velocity index of 0.60 ± 0.10. The incidence of moderate or greater PPM was 3%, and no patients experienced more than mild paravalvular leak. The rate of new permanent pacemaker implantation was 6%.
Conclusions: In patients with SAA, the DurAVR THV demonstrated promising clinical and echocardiographic outcomes at 30 days. Longer-term follow-up in larger cohorts is needed to confirm these encouraging early results.
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