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J Am Coll Cardiol, 2006; 47:1214-1223, doi:10.1016/j.jacc.2006.01.049 (Published online 8 February 2006).
© 2006 by the American College of Cardiology Foundation
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EXPEDITED REVIEW

Treatment of Calcific Aortic Stenosis With the Percutaneous Heart Valve

Mid-Term Follow-Up From the Initial Feasibility Studies: The French Experience

Alain Cribier, MD, FACC*,*, Helene Eltchaninoff, MD*, Christophe Tron, MD*, Fabrice Bauer, MD*, Carla Agatiello, MD*, Deborah Nercolini, MD*, Sydney Tapiero, MD*, Pierre-Yves Litzler, MD{dagger}, Jean-Paul Bessou, MD{dagger} and Vasilis Babaliaros, MD*

* Department of Cardiology
{dagger} Department of Cardiac Surgery, Charles Nicolle Hospital, Rouen, France

Manuscript received December 20, 2005; revised manuscript received January 19, 2006, accepted January 24, 2006.

* Reprint requests and correspondence: Dr. Alain Cribier, Service de Cardiologie, Hopital Charles Nicolle, 1 rue de Germont, 76 031 Rouen Cedex, France (Email: Alain.Cribier{at}chu-rouen.fr).

OBJECTIVES: The aim of this work was to study the feasibility, safety, efficacy, and durability of percutaneous heart valve (PHV) implantation in the aortic position.

BACKGROUND: We developed a PHV (equine pericardium valve in a balloon-expandable, stainless-steel stent) to treat patients with inoperable aortic stenosis (AS).

METHODS: Thirty-six patients (aortic valve area ≤0.7 cm2, New York Heart Association [NYHA] functional class IV, and severe comorbidities), formally declined for surgery, were recruited on a compassionate basis. The PHV was implanted by retrograde or antegrade trans-septal approach. Clinical and echocardiographic outcomes were assessed serially.

RESULTS: Twenty-seven patients were implanted successfully (23 antegrade, 4 retrograde) in the subcoronary position with improvement in valve area (0.60 ± 0.11 cm2 to 1.70 ± 0.10 cm2, p < 0.0001) and transvalvular gradient (37 ± 13 mm Hg to 9 ± 2 mm Hg, p < 0.0001). Paravalvular aortic regurgitation was grade 0 to 1 (n = 10), grade 2 (n = 12), and grade 3 (n = 5). One week post-procedure, improvement in left ventricular function (45 ± 18% to 53 ± 14%, p = 0.02) was most pronounced in patients with ejection fraction <50% (35 ± 10% to 50 ± 16%, p < 0.0001). Thirty-day major adverse events after successful implantation were 26% (pericardial tamponade, stroke, arrhythmia, urosepsis, and one death unexplained at autopsy). Eleven patients are currently alive with follow-up of 9 months (n = 2), 10 months (n = 3), 11 months (n = 1), 12 months (n = 2), 23 months (n = 1), and 26 months (n = 2). All patients experienced amelioration of symptoms (>90% NYHA functional class I to II). Percutaneous heart valve function remained unchanged during follow-up, and no deaths were device-related.

CONCLUSIONS: Percutaneous heart valve implantation is feasible in inoperable patients with end-stage AS leading to hemodynamic and clinical improvement. Continued advances and improved patient selection should decrease adverse events in the near future.




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