Medico-economic Evaluation of a Non-chirurgical Pulmonary Valve Replacement (REVALV)

Medico-economic Evaluation of a Non-chirurgical Pulmonary Valve Replacement for the Treatment of Lesions of the Ventricular Outflow Tract.

This prospective interventional study is designed to evaluate the cost/advantage ratio in the treatment of lesions of the right ventricular outflow tract using transcatheter pulmonary valved stent (Melody).

Rational : transcatheter valve insertion is a new technique enlarging the armamentarium of the treatment of RVOT obstruction and insufficiency. It real place as compared to bare stent implantation and surgery of the RVOT remains unknown.

Main objective : evaluate the cost of the procedure as compared with conventional technique.

Design : multicenter intervention prospective study. Population : 180 patients in three arms (3*60).

End point criteria :

• Primary : cost
• Secondary : rate of reoperation

Inclusion Criteria:

for the study:

• Lesions of the right ventricular outflow tract in need of surgery for stenosis or regurgitation

for the Melody arm:

• A 5 to 70 years old patient
• Weight >= 30kg
• RVOT <= to 22mm
• Patient with a dysfunction circumferential prosthetic conduct of diameter >= to 16mm.

Exclusion Criteria:

• Vein anatomy incompatibility with a 22Fr delivery health
• Left heart implantation
• RVOT incompatible with a anchoring of the stent (lik in patient operated of a tetralogy of fallot)
• Coronary anomaly with a coronary artery naer the RVOT
• Sever obstruction of the RVOT incompatible with balloon expansion
• Central vein obstruction
• Ongoing infection
• Active endocarditis
• Allergy for heparin or aspirin
• Pregnancy