Expedited Review
Treatment of Calcific Aortic Stenosis With the Percutaneous Heart Valve: Mid-Term Follow-Up From the Initial Feasibility Studies: The French Experience

https://doi.org/10.1016/j.jacc.2006.01.049Get rights and content
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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 cm2to 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.

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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Financial support was provided by Percutaneous Valve Technologies Inc. Edwards Lifesciences (Irvine, California), the company that designed and provided the percutaneous valve used, provided funding for this clinical investigation.