Early clinical outcomes of a novel self-expanding transapical transcatheter aortic valve bioprosthesis.

OBJECTIVE: Coronary obstruction remains a challenging complication of transcatheter aortic valve replacement; however, a new self-expanding transapical prosthesis may reduce this risk. The purpose of this study was to evaluate the early 1-year outcomes of patients with low coronary heights who received the Acurate TA bioprosthesis (Symetis, Ecublens, Switzerland).

METHODS: Between May 2014 and April 2015, 30 consecutive patients (aged 85 ± 6 years, 63% were female, Society of Thoracic Surgeons score 8.4 ± 6.0) with severe, symptomatic aortic stenosis underwent transcatheter aortic valve replacement with the Acurate TA bioprosthesis. Relevant patient characteristics included reoperation in 47% (n = 14), peripheral vascular disease in 43% (n = 13), and porcelain aorta in 30% (n = 9). The mean left and right coronary heights were 10.8 ± 1.5 mm and 16.4 ± 4.1 mm, respectively, with a sinus of Valsalva : annular ratio of 1.3 ± 0.8.

RESULTS: All 30 device implants were successful. The 30-day in-hospital mortality was 3.3% (n = 1), and no patients had coronary obstruction or stroke. One patient (3.3%) had apical rupture requiring cardiopulmonary bypass for repair, 1 patient (3.3%) had a localized femoral artery dissection, and 1 patient (3.7%) required a new pacemaker. There were no other complications. Mean and peak transaortic valve gradients decreased from 59 ± 17 and 84 ± 31 mm Hg to 14 ± 7 and 28 ± 12 mm Hg, respectively (P < .0005). No patients had more than mild paravalvular aortic insufficiency. At 30 days, there were no further complications and 96.7% (n = 29) were in New York Heart Association class I/II. Survival at 30 days and 1 year was 97% and 89%, respectively.

CONCLUSIONS: The Symetis Acurate TA device demonstrates high procedural success and excellent acute and 1-year patient outcomes. The device allows safe implantation in patients at higher risk for coronary artery obstruction.