Published Online
on October 2, 2006

A more recent version of this article appeared on October 10, 2006

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Submitted on May 10, 2006
Revised on August 11, 2006
Accepted on August 14, 2006

Percutaneous Implantation of the CoreValve Self-Expanding Valve Prosthesis in High-Risk Patients With Aortic Valve Disease. The Siegburg First-in-Man Study

Eberhard Grube MD^*, Jean C. Laborde MD, Ulrich Gerckens MD, Thomas Felderhoff MD, Barthel Sauren MD, Lutz Buellesfeld MD, Ralf Mueller MD, Maurizio Menichelli MD, Thomas Schmidt MD, Bernfried Zickmann MD, Stein Iversen MD, and Gregg W. Stone MD

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.).

^* To whom correspondence should be addressed. E-mail: GrubeE{at}aol.com.

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.

Key words: aorta • stenosis • valves • valvuloplasty • stents

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