First experience of transcatheter implantation of new-generation self-expanding bioprosthesis acurate neo

Abstract

Aim. To evaluate immediate results of transcatheter aortic valve implantation (TAVI) with use of novel self-expanding bioprosthesis Acurate neo™. Material and methods. TAVI procedure was performed in 69 high-to-intermediate surgical risk patients (mean age 76,8±6,1years, 31 males, 68 females) with severe calcified aortic stenosis and diverse comorbidity. Concomitant coronary artery disease was observed in 43 (62%), atrial fibrillation in 23 (33%), diabetes mellitus type 2 in 26 (38%) patients. Median Euroscore II was 4,9 (2,8; 9,0). VARC-2 criteria were applied to assess early effectiveness and safety of the procedure. Results. There were no all-cause mortality, surgical conversion, acute coronary syndrome and stroke in the study group. In-hospital and 30-day mortality was also 0%. Duration of the procedure was 100 min (75;120), hospital stay — 7 (6;8) days. Patient’s haemodynamics and clinical status were significantly improved after TAVI. Mean aortic valve pressure gradient significantly decreased from 57,4±17,6 to 11,8±4,4 mm Hg, effective aortic valve area increased from 0,65±0,17 up to 1,8±0,41 mm Hg (p<0,001). Left ventricle ejection fraction increased from 54,5±13,2 mm Hg to 57,7±12,3 before discharge (p<0,001). Moderate paravalvular aortic regurgitation was observed in only 13% of patients. Permanent pacemaker rate was 5,8%. NYHA class reduced from 2,9 to 2,0 (p<0,001). Conclusion. First Russian prospective study of TAVI with use of Acurate neo showed satisfactory hemodynamic characteristics, safety indicators and clinical efficacy of this device. Relative disadvantages of this non-repositionable valve could be generally overcome due to its distinctive features allowing precise planning, adequate navigation and accurate implantation.