First North American experience with the transfemoral ACURATE-neoTM self-expanding transcatheter aortic bioprosthesis

Background: Transcatheter aortic valve implantation (TAVI) has become a therapeutic alternative for patients presenting with severe symptomatic aortic stenosis and considered at high-surgical risk. Paravalvular leak (PVL), conduction disorders, and coronary obstruction remain unresolved procedure-related complications. The aim of this manuscript was to report the first North American experience with the ACURATE-neo(TM) aortic bioprosthesis and its ACURATE-TFTM delivery system (Symetis S.A., Ecublens, Switzerland). Methods: Transfemoral ACURATE-neo(TM) aortic valve implantation was performed in 20 patients. Clinical and echocardiographic assessment was performed at baseline, postprocedure and at least 30 days. Outcomes were assessed according to valvular academic research consortium (VARC-2) criteria. Results: The mean age was 82.7 +/- 7.0 years with a mean logistic-EuroSCORE-II of 5.0 +/- 2.9% and Society of Thoracic Surgeons score of 4.7 +/- 2.3%. Device success was achieved in all patients. The mean distance between the aortic-annulus and the left main coronary artery ostium was 14.3 +/- 3.2 mm, and eight (40%) patients had <12 mm. At 30 days, there were no deaths, conversions to surgery, or major procedure-related complications. New-pacemaker implantation was required in one (5.3%) patient. ACURATE-neo(TM) implantation resulted in a significant reduction in mean transvalvular gradient (49.9 +/- 15.8 to 9.7 +/- 5.7 mm Hg, P<0.0001) and increase in effective-orifice area (0.65 +/- 0.16 to 1.83 +/- 0.36 cm(2), P=0.001) at hospital discharge. Paravalvular leak was absent in four (20%) patients, trace in nine (45%) patients, and mild in seven (35%) patients. Hospital discharge occurred at a mean of 7.0 +/- 4.5 days, and all patients were in NYHA class I-II at a mean follow-up of 8.6 +/- 2.3 months. Conclusion: The present initial North American experience shows that the ACURATE-neo(TM) aortic bioprosthesis was safely and successfully implanted by transfemoral approach. The special design of this newer-generation device affords a stable and predictable implantation, while providing optimal hemodynamic performance with a relatively low rate of PPI. (c) 2016 Wiley Periodicals, Inc.