Findings of a mixed transfemoral aortic valve implantation program using Edwards and CoreValve devices

Abstract

Introduction and objectives: Transfemoral implantation of an Edwards SAPIEN (ES) or Medtronic CoreValve (MCV) aortic valve prosthesis is an alternative to surgical replacement for patients with severe aortic stenosis and a high surgical risk. The study's aim was to compare results obtained with these two devices.

Methods: Prospective observational study of transfemoral prosthesis implantation performed at our center.

Results: Of the 76 patients (age 83 ± 6 years, 63% female, logistic EuroSCORE 18 ± 9) included, 50 were assigned the ES and 26 the MCV device. There was no difference between the groups in age, sex, functional class, valve area, associated conditions, or EuroSCORE. Implantation was successful in 84% of the ES group and 100% of the MCV group (P = .04). There were three cases of tamponade, two aortic dissections and one valve malposition in the ES group. The two groups had similar vascular access complication rates (26% vs. 23%; P=NS), but pacemaker need was greater with the MCV (10% vs. 39%; P = .003). Mortality rates at 30 days were 12% and 20% (P = NS) in the ES and MCV groups, respectively, and at 1 year, 24% and 20% (P = NS), respectively. After a follow-up of 367 ± 266 days in the ES group and 172 ± 159 days in the MCV group, three patients died. Clinical improvement was maintained in other patients and no echocardiographic changes were observed.

Conclusions: In-hospital mortality, the complication rate and medium-term outcomes were similar with the two devices. The only difference observed was a higher implantation success rate with the MCV, although at the expense of a greater frequency of atrioventricular block.