Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description.
BACKGROUND
The design of a percutaneous implantable prosthetic heart valve has become an important area for investigation. A percutaneously implanted heart valve (PHV) composed of 3 bovine pericardial leaflets mounted within a balloon-expandable stent was developed. After ex vivo testing and animal implantation studies, the first human implantation was performed in a 57-year-old man with calcific aortic stenosis, cardiogenic shock, subacute leg ischemia, and other associated noncardiac diseases. Valve replacement had been declined for this patient, and balloon valvuloplasty had been performed with nonsustained results.


RESULTS
With the use of an antegrade transseptal approach, the PHV was successfully implanted within the diseased native aortic valve, with accurate and stable PHV positioning, no impairment of the coronary artery blood flow or of the mitral valve function, and a mild paravalvular aortic regurgitation. Immediately and at 48 hours after implantation, valve function was excellent, resulting in marked hemodynamic improvement. Over a follow-up period of 4 months, the valvular function remained satisfactory as assessed by sequential transesophageal echocardiography, and there was no recurrence of heart failure. However, severe noncardiac complications occurred, including a progressive worsening of the leg ischemia, leading to leg amputation with lack of healing, infection, and death 17 weeks after PHV implantation.


CONCLUSIONS
Nonsurgical implantation of a prosthetic heart valve can be successfully achieved with immediate and midterm hemodynamic and clinical improvement. After further device modifications, additional durability tests, and confirmatory clinical implantations, PHV might become an important therapeutic alternative for the treatment of selected patients with nonsurgical aortic stenosis.
Cribier
Alain
A
Department of Cardiology, Charles Nicolle Hospital, University of Rouen, Rouen, France. Alain.Cribier@chu-rouen.fr
Eltchaninoff
Helene
H
Bash
Assaf
A
Borenstein
Nicolas
N
Tron
Christophe
C
Bauer
Fabrice
F
Derumeaux
Genevieve
G
Anselme
Frederic
F
Laborde
François
F
Leon
Martin B
MB
D000671:Amputation, Surgical / Q000009:adverse effects; D001024:Aortic Valve Stenosis / Q000150:complications / Q000601:surgery*; D002114:Calcinosis / Q000150:complications / Q000601:surgery*; D002404:Catheterization / Q000009:adverse effects; D018450:Disease Progression; D017809:Fatal Outcome; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods*; D006801:Humans; D007511:Ischemia / Q000150:complications; D008175:Lung Neoplasms / Q000150:complications; D008297:Male; D008875:Middle Aged; D019060:Minimally Invasive Surgical Procedures / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D010195:Pancreatitis / Q000150:complications; D016491:Peripheral Vascular Diseases / Q000150:complications; D010996:Pleural Effusion / Q000150:complications; D011183:Postoperative Complications; D011654:Pulmonary Edema / Q000150:complications; D012074:Remission Induction; D018805:Sepsis / Q000209:etiology; D012770:Shock, Cardiogenic / Q000209:etiology; D035703:Therapies, Investigational / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods