| Source: |
Backer , O D , Khokhar , A A , Bieliauskas , G , Latib , A , Puri , R , Shaburishvili , T , Zhividze , M , Zirakashvili , T , Asgar , A , Krishnaswamy , A , Garcia , S A , Hahn , R T , Mahoney , P D , Waggoner , T , Ailawadi , G , Chetcuti , S , Kim , W K , Cavalcante , J , Feldt , K , Popma , J J , Coisne , A , Meier , D , Meduri , C U .... |
| Description: |
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 mm 2 to 452 mm 2 ) treated with the small-sized DurAVR THV. The mean computed tomography (CT)-derived aortic annulus area was 404±37 mm 2 , 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 cm 2 , 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. |