Percutaneous implantation of the CoreValve self-expanding valve prosthesis in high-risk patients with aortic valve disease: the Siegburg first-in-man study.
BACKGROUND
The morbidity and mortality of surgical aortic valve replacement are increased in elderly patients with multiple high-risk comorbid conditions. Therefore, a prospective, single-center, nonrandomized study was performed in high-risk patients with aortic valve disease to evaluate the feasibility and safety of percutaneous implantation of a novel self-expanding aortic valve bioprosthesis (CoreValve).


RESULTS
Symptomatic high-risk patients with an aortic valve area <1 cm2 were considered for enrollment. CoreValve implantation was performed under general anesthesia with extracorporeal support using the retrograde approach. Clinical follow-up and transthoracic echocardiography were performed after the procedure and at days 15 and 30 after device implantation to evaluate short-term patient and device outcomes. A total of 25 patients with symptomatic aortic valve stenosis (mean gradient before implantation, 44.2+/-10.8 mm Hg) and multiple comorbidities (median logistic EuroScore, 11.0%) were enrolled. Device success and procedural success were achieved in 22 (88%) and 21 (84%) patients, respectively. Successful device implantation resulted in a marked reduction in the aortic valve gradients (mean gradient after implantation, 12.4+/-3.0 mm Hg; P<0.0001). The mean aortic regurgitation grade was unchanged. Major in-hospital cardiovascular and cerebral events occurred in 8 patients (32%), including mortality in 5 patients (20%). Among 18 patients with device success surviving to discharge, no adverse events occurred within 30 days after leaving the hospital.


CONCLUSIONS
Percutaneous implantation of the self-expanding CoreValve aortic valve prosthesis in high-risk patients with aortic stenosis with or without aortic regurgitation is feasible and, when successful, results in marked hemodynamic and clinical improvement.
Grube
Eberhard
E
Department of Cardiology/Angiology, HELIOS Heart Center Siegburg, Ringstrasse 49, 53721 Siegburg, Germany. GrubeE@aol.com
Laborde
Jean C
JC
Gerckens
Ulrich
U
Felderhoff
Thomas
T
Sauren
Barthel
B
Buellesfeld
Lutz
L
Mueller
Ralf
R
Menichelli
Maurizio
M
Schmidt
Thomas
T
Zickmann
Bernfried
B
Iversen
Stein
S
Stone
Gregg W
GW
D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000502:physiology / Q000503:physiopathology*; D001022:Aortic Valve Insufficiency / Q000503:physiopathology / Q000628:therapy; D001024:Aortic Valve Stenosis / Q000503:physiopathology / Q000628:therapy*; D001705:Bioprosthesis; D000077144:Clopidogrel; D004452:Echocardiography; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000295:instrumentation / Q000379:methods*; D006439:Hemodynamics / Q000502:physiology; D006801:Humans; D008297:Male; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D011446:Prospective Studies; D012307:Risk Factors; D015607:Stents; D013921:Thrombocytopenia / Q000188:drug therapy / Q000209:etiology; D013988:Ticlopidine / Q000031:analogs & derivatives / Q000627:therapeutic use; D016896:Treatment Outcome
D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D013988:Ticlopidine