Immediate and mid-term results of transfemoral aortic valve implantation using either the Edwards Sapien transcatheter heart valve or the Medtronic CoreValve System in high-risk patients with aortic stenosis

Abstract

Objective: We sought to describe the results of transfemoral aortic valve implantation using either the Sapien prosthesis or the CoreValve System.

Background: Results of transfemoral aortic valve implantation using both commercially available prostheses have rarely been studied.

Patients: Of 236 patients at high-risk or with contraindications to surgery, consecutively referred for transcatheter aortic valve implantation between October 2006 and June 2009, 83 were treated with transfemoral aortic valve implantation. The Sapien was the only prosthesis available until May 2008 and, since then, was used as the first option, while the CoreValve System was used when contraindications to the Sapien prosthesis were present.

Results: Patients were aged 81+/-9 years, 98% in New York Heart Association classes III/IV, with predicted surgical mortalities of 26+/-14% using the EuroSCORE and 15+/-8% using the Society of Thoracic Surgeons Predicted Risk of Mortality score. Seventy-two patients were treated with the Sapien prosthesis and 11 with the CoreValve System. The valve was implanted in 94% of the cases. Thirty-day mortality was 7%. Overall, 1- and 2-year survival rates were 78+/-5% and 71+/-7%, respectively. Among patients treated with the Sapien, the 1-year survival rate was 67+/-12% in the first 20% of patients versus 86+/-5% in the last 80% of patients (p=0.02). In univariate analysis, early experience was the only significant predictor of 1-year mortality.

Conclusion: Combining the use of the Sapien and the CoreValve prostheses increases the number of patients who can be treated by transfemoral aortic valve implantation and provides satisfactory results at 2 years in this high-risk population. The results are strongly influenced by experience.