Progress and current status of percutaneous aortic valve replacement: results of three device generations of the CoreValve Revalving system.

BACKGROUND Percutaneous aortic valve replacement is a new emerging technology for interventional treatment of severe aortic valve stenosis in surgical high-risk patients. This study was intended to provide a summary of the development and current safety and efficacy status of the self-expanding CoreValve Revalving prosthesis. METHOD AND RESULTS Between 2005 and 2008, we have enrolled 136 consecutive patients with percutaneous aortic valve replacement using the CoreValve prosthesis. In this prospective nonrandomized, single-center trial, we analyzed procedural outcome, complications and clinical status up to 1 year. First, second, and third generation of the CoreValve prosthesis were implanted in 10, 24, and 102 consecutive high-risk patients (logistic EuroScore: 23.1+/-15.0%) with severe symptomatic aortic valve stenosis. Mean transvalvular pressure gradient was 41.5+/-16.7 mm Hg. The procedural success rate increased from generation 1/2 to 3 from 70.0%/70.8% to 91.2% (P=0.003). The 30-day combined rate of death/stroke/myocardial infarction was 40.0%/20.8%/14.7% (P=0.11) for generation 1, 2, and 3, with no procedural death in generation 3. Pressure gradients improved significantly with a final mean gradient of 8.1+/-3.8 mm Hg. Overall functional status assessed by New York Heart Association class improved from 3.3+/-0.5 (pre) to 1.7+/-0.7 (post) (P<0.001) and remained stable in the follow-up. CONCLUSIONS In experienced hands, percutaneous aortic valve replacement with the CoreValve system for selected patients with severe aortic valve stenosis has a high acute success rate associated with a low periprocedural mortality/stroke rate as well as remarkable clinical and hemodynamic improvements, which persist over time. Additional studies are now required to confirm these findings, particularly head-to-head comparisons with surgical valve replacement in different risk populations.