Author + information
- Received February 20, 2007
- Revision received April 10, 2007
- Accepted April 16, 2007
- Published online July 3, 2007.
- Eberhard Grube, MD, FACC⁎,1,⁎ (, )
- Gerhard Schuler, MD, FACC†,
- Lutz Buellesfeld, MD⁎,
- Ulrich Gerckens, MD⁎,
- Axel Linke, MD†,
- Peter Wenaweser, MD⁎,
- Barthel Sauren, MD⁎,
- Friedrich-Wilhelm Mohr, MD†,
- Thomas Walther, MD†,
- Bernfried Zickmann, MD⁎,
- Stein Iversen, MD⁎,
- Thomas Felderhoff, MD⁎,
- Raymond Cartier, MD‡ and
- Raoul Bonan, MD, FACC‡,1
- ↵⁎Reprint requests and correspondence:
Dr. Eberhard Grube, Department of Cardiology/Angiology, HELIOS Heart Center Siegburg, Ringstrasse 49, 53721 Siegburg, Germany.
Objectives We sought to determine both the procedural performance and safety of percutaneous implantation of the second (21-French [F])- and third (18-F)-generation CoreValve aortic valve prosthesis (CoreValve Inc., Irvine, California).
Background Percutaneous aortic valve replacement represents an emerging alternative therapy for high-risk and inoperable patients with severe symptomatic aortic valve stenosis.
Methods Patients with: 1) symptomatic, severe aortic valve stenosis (area <1 cm2); 2) age ≥80 years with a logistic EuroSCORE ≥20% (21-F group) or age ≥75 years with a logistic EuroSCORE ≥15% (18-F group); or 3) age ≥65 years plus additional prespecified risk factors were included. Introduction of the 18-F device enabled the transition from a multidisciplinary approach involving general anesthesia, surgical cut-down, and cardiopulmonary bypass to a truly percutaneous approach under local anesthesia without hemodynamic support.
Results A total of 86 patients (21-F, n = 50; 18-F, n = 36) with a mean valve area of 0.66 ± 0.19 cm2(21-F) and 0.54 ± 0.15 cm2(18-F), a mean age of 81.3 ± 5.2 years (21-F) and 83.4 ± 6.7 years (18-F), and a mean logistic EuroSCORE of 23.4 ± 13.5% (21-F) and 19.1 ± 11.1% (18-F) were recruited. Acute device success was 88%. Successful device implantation resulted in a marked reduction of aortic transvalvular gradients (mean pre 43.7 mm Hg vs. post 9.0 mm Hg, p < 0.001) with aortic regurgitation grade remaining unchanged. Acute procedural success rate was 74% (21-F: 78%; 18-F: 69%). Procedural mortality was 6%. Overall 30-day mortality rate was 12%; the combined rate of death, stroke, and myocardial infarction was 22%.
Conclusions Treatment of severe aortic valve stenosis in high-risk patients with percutaneous implantation of the CoreValve prosthesis is feasible and associated with a lower mortality rate than predicted by risk algorithms.
- Received February 20, 2007.
- Revision received April 10, 2007.
- Accepted April 16, 2007.
- American College of Cardiology Foundation