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.


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.
Grube
Eberhard
E
Departments of Cardiology, Cardiac Surgery, and Anaesthesiology, HELIOS Heart Center Siegburg, Ringstrasse 49, Siegburg, Germany. grubee@aol.com
Buellesfeld
Lutz
L
Mueller
Ralf
R
Sauren
Barthel
B
Zickmann
Bernfried
B
Nair
Dinesh
D
Beucher
Harald
H
Felderhoff
Thomas
T
Iversen
Stein
S
Gerckens
Ulrich
U
D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D001022:Aortic Valve Insufficiency / Q000601:surgery; D001024:Aortic Valve Stenosis / Q000601:surgery*; D001705:Bioprosthesis; D002305:Cardiac Tamponade / Q000209:etiology / Q000628:therapy; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D008297:Male; D009203:Myocardial Infarction / Q000453:epidemiology; D011446:Prospective Studies; D011474:Prosthesis Design; D012720:Severity of Illness Index; D020521:Stroke / Q000453:epidemiology; D016896:Treatment Outcome