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Clinical research

Procedural and 30-day outcomes following transcatheter aortic valve implantation using the third generation (18 Fr) CoreValve ReValving System: results from the multicentre, expanded evaluation registry 1-year following CE mark approval

1. Thoraxcenter, Rotterdam, The Netherlands; 2. Seigburg Helios Heart Center, Seigburg, Germany; 3. Amphia Breda, Breda, The Netherlands; 4. Leipzig University Heart Center, Leipzig, Germany; 5. Graz Medical University Clinic, Graz, Austria; 6. Padova Hospital Policlinico, Padova, Italy; 7. Hospital Vittoria Emanuele Ferrarotto, Catania, Italy; 8. Bern University Hospital, Bern, Switzerland; 9. Clinique Pasteur, Toulouse, France

Aims: To describe the procedural performance and 30-day outcomes following implantation using the 18 Fr CoreValve Revalving System (CRS) as part of the multicentre, expanded evaluation registry, 1-year after obtaining CE mark approval.

Methods and results: 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. 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 49.4±13.9 to 3±2 mmHg. All 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) was 8% and the combined rate of death, stroke and myocardial infarction was 9.3%.

Conclusions: The results of this study demonstrate the high rate of procedural success and a low 30-day mortality in a large cohort of high-risk patients undergoing transcatheter aortic valve implantation (TAVI) with the CRS.

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