EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2026
Thirty-day outcomes of a novel biomimetic balloon-expandable transcatheter heart valve in patients with small aortic annuli.
СтатьяНазвание и аннотация: Перевод в очереди
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Backer Ole De, Khokhar Arif A, Bieliauskas Gintautas, Latib Azeem, Puri Rishi, Shaburishvili Tamaz, Zhividze Maia, Zirakashvili Teona, Asgar Anita, Krishnaswamy Amar, Garcia Santiago A, Hahn Rebecca T, Mahoney Paul D, Waggoner Thomas, Ailawadi Gorav, Chetcuti Stanley, Kim Won-Keun, Cavalcante Joao, Feldt Kari, Popma Jeffrey J, Coisne Augustin, Meier David, Meduri Christopher U, Windecker Stephan, Reardon Michael J, Bapat Vinayak N
Аннотация
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.
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.