Potential anatomical predictors of in-hospital complications following transfemoral aortic valve replacement with the MedInzh prosthesis: a pilot study

Abstract

Until recently, the only transcatheter synthetic aortic prostheses available on the Russian market were those with transapical or transaortic delivery systems. A synthetic prosthesis with a novel transfemoral delivery system has been developed in our country; however, the literature contains no data on the results of its use. Aim: To assess the incidence of in-hospital complications in the early postoperative period following transcatheter aortic valve replacement (TAVR) with the MedInzh prosthesis in patients with degenerative aortic valve stenosis, based on multislice computed tomography (panaortography) data (MSCT), and to identify their potential anatomical predictors. Material and methods. This clinical trial is a prospective, single-center pilot study included patients with confirmed severe aortic stenosis: effective aortic valve orifice area of ≤ 1.0 cm²; mean transvalvular gradient ≥ 40 mmHg. All patients underwent transfemoral valve replacement for correction of severe degenerative aortic stenosis using the synthetic MedInzh prosthesis. All procedures were performed between 2023 and 2025. Results. A total of 30 patients at moderate and high surgical risk were enrolled; median age was 75 (68.5; 77.5) years; 27% were male. The incidence of in-hospital complications was 27% (acute cerebrovascular accident 7%; ventricular arrhythmias 7%; acute common iliac artery thrombosis 7%; acute myocardial ischemia 3%; lymphocele 3%). The odds of complications after TAVR increased when the minimal diameter of the common iliac artery on the access side was ≤ 10.5 mm (OR = 19.2; 95% CI: 1.844–199.9); with the longitudinal diameter of the external iliac artery was ≤ 7.75 mm (OR = 25.5; 95% CI: 2.5–276); and with a transverse diameter was ≤ 8.2 mm (OR = 8; 95% CI: 1.2–55). Conclusions. Among intermediate- and high-risk patients with severe symptomatic aortic stenosis undergoing transfemoral aortic valve replacement with the MedInzh prosthesis, the rate of in-hospital complications was 27%, with vascular complications accounting for 7%. MSCT panaortography results suggest that the diameter of the common iliac arteries, the minimal diameter of the common iliac artery, and the longitudinal and transverse diameters of the external iliac arteries on the access side are potential anatomical predictors associated with the development of vascular complications after TAVR.