Treatment of calcific aortic stenosis with the percutaneous heart valve: mid-term follow-up from the initial feasibility studies: the French experience.
OBJECTIVE
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 < or =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.
Cribier
Alain
A
Department of Cardiology, Charles Nicolle Hospital, Rouen, France. Alain.Cribier@chu-rouen.fr
Eltchaninoff
Helene
H
Tron
Christophe
C
Bauer
Fabrice
F
Agatiello
Carla
C
Nercolini
Deborah
D
Tapiero
Sydney
S
Litzler
Pierre-Yves
PY
Bessou
Jean-Paul
JP
Babaliaros
Vasilis
V
D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve; D001024:Aortic Valve Stenosis / Q000150:complications* / Q000601:surgery*; D002114:Calcinosis / Q000150:complications* / Q000601:surgery*; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006349:Heart Valve Diseases / Q000150:complications / Q000601:surgery; D006350:Heart Valve Prosthesis; D006801:Humans; D008297:Male; D008875:Middle Aged; D013997:Time Factors