Primary Outcomes of XPand System for Transcatheter Aortic Valve Implantation
Introduction. Recent developments in the field of transcatheter aortic valve implantation (TAVI) have led to the increasing interest to optimization of this procedure and related devices for patients with severe aortic valve stenosis. This is the first study to examine the novel XPand device jointly developed by German, French and Ukrainian scientists. This study aims to contribute to this growing area of research by exploring efficacy and safety in patients with severe aortic stenosis. Purpose. To evaluate the procedure effectiveness and long-term outcomes of XPand device implantation in patients with severe aortic valve stenosis. Materials and methods. We initiated a single-center clinical trial to evaluate the XPand device and already performed an initial analysis of the primary outcomes. Patients who met the inclusion criteria underwent full examination and TAVI procedure using the XPand system. Postoperative result evaluation was performed according to the established protocol. Results. Primary good results for TAVI XPand were obtained in all patients (n=7). The average length of stay in the hospital after the procedure was 20±1.25 days. The postoperative period was unremarkable. In 71.5% of patients, the minimal paravalvular insufficiency or insufficiency absence were obtained after the final aortography. Conclusions. The first experience of using the modern device XPand for transcatheter implantation of the aortic valve prosthesis confirms its effectiveness and safety in patients with severe aortic stenosis.