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J Am Coll Cardiol, 2004; 43:698-703, doi:10.1016/j.jacc.2003.11.026
© 2004 by the American College of Cardiology Foundation
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EXPEDITED REVIEW

Early experience with percutaneous transcatheter implantation of heart valve prosthesis for the treatment of end-stage inoperable patients with calcific aortic stenosis

Alain Cribier, MD, FACC*,*, Hélène Eltchaninoff, MD*, Christophe Tron, MD*, Fabrice Bauer, MD*, Carla Agatiello, MD*, Laurent Sebagh, MD*, Assaf Bash, PhD§, Danielle Nusimovici, MD§, P. Y. Litzler, MD{dagger}, Jean-Paul Bessou, MD{dagger} and Martin B. Leon, MD, FACC{ddagger}

* Department of Cardiology, Charles Nicolle Hospital, University of Rouen, Rouen, France
{dagger} Department of Cardiac Surgery, Charles Nicolle Hospital, University of Rouen, Rouen, France
{ddagger} Cardiovascular Research Foundation, Lenox Hill Hospital, New York, New York, USA
§ Percutaneous Valve Technologies, Fort Lee, New Jersey, USA

* Reprint requests and correspondence to: Dr. Alain Cribier, Service de Cardiologie, Hôpital Charles Nicolle, 1 rue de Germont, 76 000, Rouen, France.
Alain.Cribier{at}chu-rouen.fr

OBJECTIVES: This study wad done to assess the results of percutaneous heart valve (PHV) implantation in non-surgical patients with end-stage calcific aortic stenosis.

BACKGROUND: Replacement of PHV has been shown to be feasible in animals and humans. We developed a PHV composed of three pericardial leaflets inserted within a balloon-expandable stainless steel stent. We report the acute and early follow-up results of the initial six PHV implantations.

METHODS: An anterograde approach was used in all cases. The PHV, crimped over a 22-mm diameter balloon, was advanced through a 24-F sheath from the femoral vein to the aortic valve and delivered by balloon inflation. Clinical, hemodynamic, and echocardiographic outcomes were assessed serially.

RESULTS: All patients were in New York Heart Association functional class IV. The PHV was successfully delivered in five patients. Early migration with subsequent death occurred in one patient who presented with a torn native valve. Acute hemodynamic and angiographic results showed no residual gradient, mild (three patients) or severe (two patients) aortic regurgitation, and patent coronary arteries. On echocardiography, the aortic valve area was increased from 0.5 ± 0.1 cm2 to 1.70 ± 0.03 cm2 and the aortic regurgitation was paravalvular. Marked and sustained hemodynamic and clinical improvement was observed after successful PHV implants. The first three patients died of a non-cardiac cause at 18, 4, and 2 weeks, respectively, and the other patients are alive at 8 weeks with no signs of heart failure.

CONCLUSIONS: Implantation of the PHV can be achieved in patients with end-stage calcific aortic stenosis and might become an important therapeutic option for patients not amenable to surgical valve replacement.

Abbreviations and Acronyms
  PHV = percutaneous heart valve
  NYHA = New York Heart Association




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