Clinical evaluation of the safety and performance of percutaneous implantation of the CoreValve AV prosthesis for patients presenting high risk for surg. valve

Home

Johan Bosmans, Inez Rodrigus, Bernard Paelinck, Christian Vrints, Jean-Claude Laborde, Eberhard Grube, Ulrich Gerckens, Gerhard Schuler, Patrick W. Serruys, Peter Dejaegere, Peter den Heijer1, Raoul Bonan, Carlos E. Ruiz, Edouard Benit, The Corevalve Investigators

 

UZ Antwerpen, Antwerpen

Objectives: Percutaneous aortic valve replacement is a promising new interventional treatment modality. The aim of this prospective fase II study is to evaluate the feasibility and the safety of the CoreValve self-expanding bioprosthesis.

Methods: Patients with symptomatic aortic valve stenosis and considered as poor surgical candidates were included. All patients were > 80years old, and/or had a surgical risk with the logistic Euroscore >20%, or were > 65 years old with at least 2 severe co-morbidities. The valve was deployed by a retrograde arterial 21 Fr delivery catheter system, with aid of cardiopulmonary bypass

Results: Sixty patients were included. Fourthy nine were considered “high-risk” (logistic Euroscore 23, 4+- 14) and 11 were considered “inoperable” (logistic Euroscore 31.6+-16). Valve implantation was successful in 55/60 (92%), and failed in 5/60 (8%). Mean gradient after implantation was 9, 1 +- 4, 5 mm Hg and mean valve area 1, 6 +- 0, 4 cm2. Paravalvular leak occurred in 1 patient. In-hospital mortality of the “high risk” patients was 8% and of the “inoperable” patients 36%. Overall, in-hospital mortality was 13%. In 4 patients (8%), conversion to cardiac surgery occurred. After successful implantation, valve dysfunction never occurred. There were no major clinical complications in initial follow-up.

Conclusions: This study shows that percutaneous implantation of the self-expanding 21Fr CoreValve aortic valve bioprosthesis in “high-risk” patients with symptomatic aortic stenosis is feasible. When successful, the procedure results in marked hemodynamic and clinical improvement. In “inoperable” patients, however, procedural mortality is high. Further investigation should precise optimal patient selection and result in a smaller delivery catheter system, probably without use of cardiopulmonary bypass.