Thirty-day outcomes of a novel biomimetic balloon-expandable transcatheter heart valve in patients with small aortic annuli

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 mm2 to 452 mm2) treated with the small-sized DurAVR THV. The mean computed tomography (CT)-derived aortic annulus area was 404±37 mm2, with a mean diameter of 22.7±1.0 mm. Outcomes at 30 days, including PPM, were evaluated per Valve Academic Research Consortium 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 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.