Percutaneous implantation of the corevalve self-expanding valve prosthesis in high-risk patients with aortic valve disease : The siegburg first-in-man study

• Published in: Circulation (New York, N.Y.) Vol. 114; no. 15; pp. 1616 - 1624
• Main Authors: GRUBE, Eberhard, LABORDE, Jean C, IVERSEN, Stein, STONE, Gregg W, GERCKENS, Ulrich, FELDERHOFF, Thomas, SAUREN, Barthel, BUELLESFELD, Lutz, MUELLER, Ralf, MENICHELLI, Maurizio, SCHMIDT, Thomas, ZICKMANN, Bernfried
• Format: Journal Article
• Language: English
• Published: Hagerstown, MD Lippincott Williams & Wilkins 10.10.2006
• Subjects: Aged; Aged, 80 and over; Aortic Valve - physiology; Aortic Valve - physiopathology; Aortic Valve Insufficiency - physiopathology; Aortic Valve Insufficiency - therapy; Aortic Valve Stenosis - physiopathology; Aortic Valve Stenosis - therapy; Biological and medical sciences; Bioprosthesis; Blood and lymphatic vessels; Cardiology. Vascular system; Cardiovascular system; Diseases of the aorta; Diseases of the peripheral vessels. Diseases of the vena cava. Miscellaneous; Echocardiography; Female; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation - instrumentation; Heart Valve Prosthesis Implantation - methods; Hemodynamics - physiology; Humans; Male; Medical sciences; Pharmacology. Drug treatments; Platelet Aggregation Inhibitors - therapeutic use; Prospective Studies; Risk Factors; Stents; Thrombocytopenia - drug therapy; Thrombocytopenia - etiology; Ticlopidine - analogs & derivatives; Ticlopidine - therapeutic use; Treatment Outcome; Vasodilator agents. Cerebral vasodilators; Human; Prosthesis; stents; valves; Stenosis; Cardiovascular disease; Aortic valve disease; Stent; Artery; Percutaneous route; valvuloplasty; Cardiac valvular disease; Blood vessel; Risk factor; Aorta; Circulatory system
• ISSN: 0009-7322; 1524-4539
• DOI: 10.1161/CIRCULATIONAHA.106.639450

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). 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. 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.