Society of Cardiovascular Anesthesiologists

Literature Reviews

Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis; first human case description.

Cribier A, Eltchaninoff H, Bash A, Borenstein N, Tron C, Bauer F, Derumeaux G, Anselme F, Laborde F, Leon MB. Circulation 106:3006-3008, 2002.

Reviewer: Mark A. Chaney, MD
University of Chicago
Chicago, IL

Abstract Excerpt: The design of a percutaneous implantable prosthetic heart valve has become an important area for investigation. A percutaneously implanted heart valve (PHV) composed of bovine pericardial leaflets mounted within a balloon-expandable stent was initially developed. Following 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. Previous balloon valvuloplasty had been unsuccessful and conventional surgical management was not an option. 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 two days after implantation, valve function was excellent, resulting in marked hemodynamic improvement. Over a follow-up period of four 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 seventeen weeks after PHV implantation. The authors conclude that 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.

Comments: Percutaneous catheter-based systems for the treatment of valvular heart disease have been designed and studied in animal models for several years. The goals of these investigators were to develop a biological heart valve, mounted on a specifically designed balloon-expandable stent, which could be delivered percutaneously via standard catheter-based techniques and implanted within a diseased aortic valve in calcific aortic stenosis. This concept was based on the investigator's personal autopsy observations on calcific aortic stenosis showing that a stent could effectively open while strongly adhering within the native diseased valve without impairing the coronary ostia or the mitral valve. An original percutaneous heart valve (PHV) was developed and function and durability were first tested in ex vivo pulse duplicator models. In animal models, the PHV was accurately delivered by balloon inflation at various cardiac sites. In this initial first human implantation, the PHV was a "last-resort". This 57 year-old man with severe calcific aortic stenosis had been declined conventional aortic valve replacement by several cardiac surgical teams because of hemodynamic instability and significant comorbidities. Previous aortic valvuloplasty performed via the transseptal antegrade approach was unsuccessful. Under these desperate circumstances, potentially lifesaving intervention that might also bridge surgical valve replacement, the approval of the Institutional Ethics Committee was obtained, and the patient and relatives consented to attempted implantation of the investigational PHV. The procedure was undertaken under mild sedation and local anesthesia. The antegrade approach (standard transseptal catheterization) via the right femoral vein was used for PHV insertion. The PHV was easily advanced across the interatrial septum and within the diseased stenotic aortic valve. Immediately after PHV deployment, mean transvalvular gradient was 6 mm Hg (previously 30 mm Hg) and normal flow was present (via angiography) across the aortic valve. A dramatic, immediate clinical improvement (resolution of congestive heart failure) was exhibited. PHV function remained satisfactory (via TEE examinations) at 1, 4, 7, and 9 weeks following implantation. However, several noncardiac-related complications occurred, leading to death 17 weeks after PHV implantation. No acute episode of congestive heart failure occurred during this time. Unfortunately, autopsy could not be obtained. This dramatic case demonstrates the feasibility of implanting a prosthetic heart valve percutaneously, with the use of standard interventional techniques, within the native diseased valve of a patient with calcific aortic stenosis. At present, PHV is targeted for end-stage patients with severe aortic stenosis not amenable to surgical valve replacement. In the future, with further device modifications and corroborative clinical studies, this less invasive, catheter-based approach to the treatment of aortic stenosis may become an important and versatile therapeutic alternative.

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