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J Am Coll Cardiol, 2007; 50:69-76, doi:10.1016/j.jacc.2007.04.047
(Published online 5 June 2007). © 2007 by the American College of Cardiology Foundation |
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,1
* HELIOS Heart Center Siegburg, Siegburg, Germany
Heart Center Leipzig, Leipzig, Germany
Institut de Cardiologie de Montreal, Montreal, Canada.
Manuscript received February 20, 2007; revised manuscript received April 10, 2007, accepted April 16, 2007.
* Reprint requests and correspondence: Dr. Eberhard Grube, Department of Cardiology/Angiology, HELIOS Heart Center Siegburg, Ringstrasse 49, 53721 Siegburg, Germany. (Email: GrubeE{at}aol.com).
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.
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