Published online before print October 2, 2006, doi: 10.1161/CIRCULATIONAHA.106.639450
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(Circulation. 2006;114:1616-1624.)
© 2006 American Heart Association, Inc.
Valvular Heart Disease |
Percutaneous Implantation of the CoreValve Self-Expanding Valve Prosthesis in High-Risk Patients With Aortic Valve Disease
The Siegburg First-in-Man Study
From the HELIOS Heart Center Siegburg, Departments of Cardiology (E.G., U.G., L.B., R.M., M.M., T.S.), Cardiac Surgery (T.F., S.I.), and Anesthesiology (B.S., B.Z.), Siegburg, Germany; Clinique Pasteur, Toulouse, France (J.C.L.); and Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY (G.W.S.).
Correspondence to Eberhard Grube, MD, Department of Cardiology/Angiology, HELIOS Heart Center Siegburg, Ringstrasse 49, 53721 Siegburg, Germany. E-mail GrubeE{at}aol.com
Received May 10, 2006; revision received August 11, 2006; accepted August 14, 2006.
Background— The morbidity and mortality of surgical aortic valve replacement are increased in elderly patients with multiple high-risk comorbid conditions. Therefore, a prospective, single-center, nonrandomized study was performed in high-risk patients with aortic valve disease to evaluate the feasibility and safety of percutaneous implantation of a novel self-expanding aortic valve bioprosthesis (CoreValve).
Methods and Results— Symptomatic high-risk patients with an aortic valve area <1 cm2 were considered for enrollment. CoreValve implantation was performed under general anesthesia with extracorporeal support using the retrograde approach. Clinical follow-up and transthoracic echocardiography were performed after the procedure and at days 15 and 30 after device implantation to evaluate short-term patient and device outcomes. A total of 25 patients with symptomatic aortic valve stenosis (mean gradient before implantation, 44.2±10.8 mm Hg) and multiple comorbidities (median logistic EuroScore, 11.0%) were enrolled. Device success and procedural success were achieved in 22 (88%) and 21 (84%) patients, respectively. Successful device implantation resulted in a marked reduction in the aortic valve gradients (mean gradient after implantation, 12.4±3.0 mm Hg; P<0.0001). The mean aortic regurgitation grade was unchanged. Major in-hospital cardiovascular and cerebral events occurred in 8 patients (32%), including mortality in 5 patients (20%). Among 18 patients with device success surviving to discharge, no adverse events occurred within 30 days after leaving the hospital.
Conclusions— Percutaneous implantation of the self-expanding CoreValve aortic valve prosthesis in high-risk patients with aortic stenosis with or without aortic regurgitation is feasible and, when successful, results in marked hemodynamic and clinical improvement.
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