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 ,
Jean-Paul Bessou, MD and
Vasilis Babaliaros, MD*
* Department of Cardiology, Charles Nicolle Hospital, Rouen, France
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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Abbreviations and Acronyms
| | AVA = aortic valve area | | BAV = balloon aortic valvuloplasty | | I-REVIVE = Initial Registry of EndoVascular Implantation of Valves in Europe trial | | MACCE = major adverse cardiac and cerebrovascular events | | MI = myocardial infarction | | NYHA = New York Heart Association | | PHV = percutaneous heart valve | | RECAST = Registry of Endovascular Critical Aortic Stenosis Treatment trial | | TTE = transthoracic echocardiography |
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