Abstract
Background: Over 2000 transcatheter aortic valve implantations (TAVI) have been performed worldwide by means of two differing technologies. Initial reports, limited by the initial learning curve and small sample size, documented rates of procedural success and 30-day mortality in three-quarters and more than one-tenth of patients, respectively. Objective: To describe the procedural performance and 30-day outcomes following implantation using the 18F CoreValve Revalving System (CRS) as part of the multicenter, expanded evaluation registry, 1-year after obtaining CE mark approval. Methods: Patients with symptomatic severe aortic stenosis and logistic EuroSCORE ≥ 15%, or age ≥ 75 years, or age ≥ 65 years associated with pre-defined risk factors, and for whom a physician proctor and a clinical specialist were in attendance during the implantation and who collected the clinical data, were included. Results: From April 2007, to April 2008, 646 patients with a mean age of 81± 6.6 years, mean aortic valve area 0.6 ± 0.2 cm2, and logistic EuroSCORE of 23.1± 13.8% were recruited. After valve implantation, the mean transaortic valve gradient decreased from 50.4 ± 16.8 to 3.2 ± 5.2 mmHg. Only one percent of patients had paravalvular aortic regurgitation ≥ grade 2. The rate of procedural success was 97%. The procedural mortality rate was 1.5%. At 30 days, the all-cause mortality rate (i.e. including procedural mortality) was 8% and the combined rate of death, stroke and myocardial infarction was 9.3%. Conclusion: The results of this study demonstrate a high rate of procedural success and low rate of 30-day mortality in a large cohort of high-risk patients undergoing TAVI with the CRS self-expanding aortic valve prosthesis.
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