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

doi:10.1016/j.jacc.2006.01.049


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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, 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) implantationin the aortic position.

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

METHODS: Thirty-six patients (aortic valve area $≤$ 0.7 cm², New York HeartAssociation [NYHA] functional class IV, and severe comorbidities),formally declined for surgery, were recruited on a compassionatebasis. The PHV was implanted by retrograde or antegrade trans-septalapproach. Clinical and echocardiographic outcomes were assessedserially.

RESULTS: Twenty-seven patients were implanted successfully (23 antegrade,4 retrograde) in the subcoronary position with improvement invalve area (0.60 ± 0.11 cm² to 1.70 ± 0.10 cm²,p < 0.0001) and transvalvular gradient (37 ± 13 mmHg to 9 ± 2 mm Hg, p < 0.0001). Paravalvular aorticregurgitation was grade 0 to 1 (n = 10), grade 2 (n = 12), andgrade 3 (n = 5). One week post-procedure, improvement in leftventricular 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 implantationwere 26% (pericardial tamponade, stroke, arrhythmia, urosepsis,and one death unexplained at autopsy). Eleven patients are currentlyalive with follow-up of 9 months (n = 2), 10 months (n = 3),11 months (n = 1), 12 months (n = 2), 23 months (n = 1), and26 months (n = 2). All patients experienced amelioration ofsymptoms (>90% NYHA functional class I to II). Percutaneousheart valve function remained unchanged during follow-up, andno deaths were device-related.

CONCLUSIONS: Percutaneous heart valve implantation is feasible in inoperablepatients with end-stage AS leading to hemodynamic and clinicalimprovement. Continued advances and improved patient selectionshould 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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