Percutaneous aortic valve replacement for severe aortic stenosis in high-risk patients using the second-and current third-generation self-expanding corevalve prosthesis : Device success and 30-day clinical outcome

• Published in: Journal of the American College of Cardiology 2007-07, Vol.50 (1), p.69-76
• Main Authors: GRUBE, Eberhard, SCHULER, Gerhard, IVERSEN, Stein, FELDERHOFF, Thomas, CARTIER, Raymond, BONAN, Raoul, BUELLESFELD, Lutz, GERCKENS, Ulrich, LINKE, Axel, WENAWESER, Peter, SAUREN, Barthel, MOHR, Friedrich-Wilhelm, WALTHER, Thomas, ZICKMANN, Bernfried
• Format: Article
• Language: English
• Subjects: Age Factors; Aged; Aged, 80 and over; Aortic Valve Stenosis - diagnosis; Aortic Valve Stenosis - mortality; Aortic Valve Stenosis - therapy; Biological and medical sciences; Bioprosthesis; Cardiac Catheterization; Cardiology; Cardiology. Vascular system; Coronary vessels; Female; Follow-Up Studies; Heart attacks; Heart Valve Prosthesis Implantation - methods; Heart Valve Prosthesis Implantation - mortality; Humans; Male; Medical sciences; Mortality; Orthopedic surgery; Prospective Studies; Prosthesis Design; Risk Assessment; Severity of Illness Index; Single-Blind Method; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases; Survival Rate; Treatment Outcome
• ISSN: 0735-1097; 1558-3597
• DOI: 10.1016/j.jacc.2007.04.047

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). Percutaneous aortic valve replacement represents an emerging alternative therapy for high-risk and inoperable patients with severe symptomatic aortic valve stenosis. Patients with: 1) symptomatic, severe aortic valve stenosis (area or =80 years with a logistic EuroSCORE > or =20% (21-F group) or age > or =75 years with a logistic EuroSCORE > or =15% (18-F group); or 3) age > or =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. 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%. 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.