Abstract 3531: First North American Experience With Percutaneous Aortic Valve Replacement (CoreValve) in Patients Unsuitable for Surgical Aortic Valve Replacement
BACKGROUND: Percutaneous aortic valve replacement (PAVR) is an emerging alternative to palliative medical therapy for non-surgical patients with severe aortic stenosis (AS). We describe the first North American experience of PAVR with the CoreValve Revalving™ system (Generation II; 21 French (Fr)) which includes a self-expandable porcine bioprosthesis within in a nitinol frame.
METHODS: Patients with symptomatic, severe (area < 0.6 cm2/m2) AS who had been refused aortic valve surgery because of elevated operative risk were enrolled. A multi-disciplinary approach involved general anesthesia, surgical peripheral arterial access, and femoral vein-femoral artery cardiopulmonary bypass (CPB). Aortic balloon valvuloplasty was performed first, then retrograde CoreValve PAVR.
RESULTS: Between March 1, 2005 -March 31, 2006, 9 men and 9 women (mean (SD) age 82(10) years; range 64–90 years) were referred for PAVR. Four women and 2 men (mean (SD) age 82 (10) years) gave informed consent. One man had severe peripheral arterial disease and was not attempted. In one woman the common iliac artery internal diameters were too small to permit advancement of the 21 Fr. Device. This procedure was safely aborted. Four patients underwent PAVR. One patient had a 70% stenosis of the mid-left anterior descending coronary artery and underwent percutaneous coronary intervention (PCI) combined with simultaneous PAVR. A Medtronic Endeavor drug eluting stent was selected because of its putative low thrombogenicity. The male patient needed a 7 mm balloon dilatation of his left Iliac artery to allow progression of the device. In all 4 cases, CPB duration was <40 min, the bioprosthetic valve area was >1.2 cm2 and paravalvular regurgitation was ≤Grade I. No major complications occurred. Follow-up (range 1 to 4 months) confirmed hemodynamic and functional improvements in all PAVR cases. Four referred patients who were undergoing assessment for PAVR, and in whom consent had not yet been obtained, died during the study period.
CONCLUSIONS: PAVR with the Self-expandable CoreValve 21 Fr. prosthesis is feasible and safe. PAVR may be combined with other vascular interventions, including PCI and peripheral angioplasty. A multidisciplinary approach is necessary to optimize patient outcome.