United States feasibility study of transcatheter insertion of a stented aortic valve by the left ventricular apex

Background. Recent US and European registries have indicated 30% to 60% of patients with critical valvular aortic stenosis (AS) are not treated surgically, usually due to advanced age and comorbidities. We report on a Food and Drug Administration approved feasibility study of a less invasive transcatheter approach to potentially treat these high-risk patients. Methods. Between December 2006 and February 18, 2008, 40 patients underwent transcatheter insertion of a balloon expandable stainless-steel stent with an internally mounted three-leaflet equine pericardial valve (Edwards Sapien Transcatheter Heart Valve; Edwards Life-sciences, Irvine, CA) into the aortic annulus using a transapical left ventricular insertion (TA-AVI). Patients were inoperable by conventional surgery, or extremely high risk based on Society of Thoracic Surgeons score greater than 15% or other documented risk factors. Results. All 40 valves were successfully delivered and 35 were successfully seated. Two valves embolized and required open aortic valve replacement (AVR), and one case of severe regurgitation later required AVR. In a further two patients placed on cardiopulmonary support, one valve later embolized and one migrated. There were 7 (17.5%) deaths within 30 days, and a further 2 (5%) deaths before discharge at 42 and 72 days. There were no immediate postoperative strokes after successful deployment. Valve area improved from 0.62 cm(2) (SD of 0.13) to 1.61 cm(2) (SD 0.37) at 30 days (p = < 0.0001), with mean perivalvular regurgitation of 1.19 (SD 0.80). Mean follow-up was 143 days (SD 166 days) with 6 further deaths from comorbid disease, none valve or cardiac related. The Kaplan-Meier survival was 81.8% +/- 6.2% at 1 month and 71.7% +/- 7.7% at 3 months. Conclusions. Transapical insertion of a balloon expandable stented valve is feasible but carries considerable risk and will be further evaluated in the PARTNER (Placement of AoRTic traNscathetER valve) randomized trial.