Percutaneous Implantation of the CoreValve® Self-Expanding Aortic Valve Prosthesis in Patients With Severe Aortic Stenosis: Early Experience in Spain

Introduction and objectives. The aim of the study was to describe early experience and medium-term follow-up with the CoreValve (R) self-expanding aortic prosthesis at three Spanish hospitals. Methods. The study included patients with severe symptomatic aortic stenosis. Other inclusion criteria were: aortic valve area <1 cm(2) (<0.6 cm(2)/m(2)); aortic valve annulus diameter in the range 20-27 mm; diameter of the ascending aorta at the level of the sinotubular junction <= 40 mm (small prosthesis) or : 43 mm (large prosthesis), and femoral artery diameter >6 mm. Results. The study included 108 patients with a mean age of 78.6 +/- 6.7 years, a mean aortic valve area of 0.63 +/- 0.2 cm(2) and a mean logistic EuroSCORE of 16%+/- 13.9% (range, 2.27%-86.4%). After valve implantation, the maximum echocardiographic transaortic valve gradient decreased from 83.8 +/- 23 to 12.6 +/- 6 mmHg. No patient presented with greater than grade-2 residual aortic regurgitation on angiography. The procedural success rate was 98.1%. No patient died during the procedure. Definitive pacemaker implantation was carried out for atrioventricular block in 38 patients (35.2%). At 30 days, all-cause mortality and the rate of the combined end-point of death, stroke, myocardial infarction or referral for surgery were 7.4% and 8.3%, respectively. The estimated 1-year survival rate calculated using the Kaplan-Meier method was 82.3% (for a median follow-up period of 7.6 months). Conclusions. Our early experience indicates that percutaneous aortic valve replacement is a safe and practical therapeutic option for patients with severe aortic stenosis who are at a high surgical risk.