Thirty-day outcomes of a novel biomimetic balloon-expandable transcatheter heart valve in patients with small aortic annuli
Ole De Backer, Arif Khokhar, Gintautas Bieliauskas, Azeem Latib, Rishi Puri, Tamaz Shaburishvili, Maia Zhividze, Teona Zirakashvili, Anita Asgar, Amar Krishnaswamy, Santiago García, Rebecca T Hahn, Paul Mahoney, Thomas Waggoner, Gorav Ailawadi, Stanley Chetcuti, Won‐Keun Kim, João L. Cavalcante, Kari Feldt, Jeffrey J. Popma, Augustin Coisne, David Meier, Christopher Meduri, Stephan Windecker, Michael J. Reardon, Vinayak Bapat
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: , 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: , 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.