Abstract 3791: Experience with 21 French Percutaneous CoreValve Aortic Valve Replacement in Patients Unsuitable for Surgical Aortic Valve Replacement
BACKGROUND: Percutaneous aortic valve replacement (PAVR) is an emerging, alternative to palliative medical therapy for high risk and non-surgical patients with severe aortic stenosis (AS). We report the global experience of PAVR with the CoreValve Revalving™ system, 21 French generation 2, which includes a self-expandable porcine bioprosthesis within in a nitinol frame.
METHODS: Patients with symptomatic, severe (area < 0.6 cm2/m2) AS aged ≥ 80 y. and/or Logistic Euroscore (LEs) ≥ 20% and/or ≥ 65 y. + severe comorbidities were enrolled. A multi-disciplinary approach involved general anesthesia, surgical arterial access and femoral-femoral cardiopulmonary bypass (CPB). Aortic balloon valvuloplasty was performed prior to 21 Fr CoreValve PAVR.
RESULTS: Since August 2005, 44 consecutive patients (pts), 34 high risk (LEs = 22.4 ± 12) and 8 inoperable pts (LEs = 28.8 ± 15) with severe native aortic stenosis in 42 pts and post surgical bioprosthesis implant in 2 were included: mean age: 80.4 ± 6.5 y., 30 females, mean AVA: 0.7 ± 0.1 cm2. Technical failure occurred in 4 cases, 1 inability to cross the valve and 3 misplacements with immediate conversions to surgery. Procedural complications included 1 myocardial infarction, 2 aortic dissections and 2 high grade AV blocks requiring pacemaker. Immediate results in 39 successful implants showed a post-procedure mean AVA: 1.6 ± 0.4 cm2. In 7 pts, there were significant paravalvular leaks by TEE. In hospital mortality occurred in 7/44 pts, including 3/36 (9%) in the high risk patients. Follow-up (range 1 to 15 mo., mean 9 mo.) confirmed hemodynamic and functional improvements in all PAVR cases with 30/34 pts improved to NYHA - FC I-II.
CONCLUSIONS: PAVR with the 21 Fr self-expandable CoreValve prosthesis is feasible and safe. When successful, the procedure results in marked hemodynamic and clinical improvement and follow-up up to 15 months confirms sustained clinical and hemodynamic benefit.