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Description of Disease. Congenital heart disease, including tetrology of Fallot, pulmonary atresia, and transposition of the great arteries, is generally treated by surgical repair at an early age. This involves reconstruction of the right ventricular outflow tract (RVOT) and pulmonary valve by means of a surgical homograft or a bovine-derived valved conduit. These repairs are prone to development of pulmonary stenosis or regurgitation over long periods of follow-up.

As individuals with prior congenital heart disease repair are living longer into adulthood, the problem of RVOT dysfunction following initial repair has become more common. Calcification of the RVOT conduit can lead to pulmonary stenosis, while aneurysmal dilatation can result in pulmonary regurgitation. RVOT dysfunction can lead to decreased exercise tolerance, potentially fatal arrhythmias, and/or irreversible right ventricular dysfunction.

Interventions for RVOT dysfunction often require repeat open heart surgery, resulting to numerous open heart procedures in patients who live into adulthood. Treatment options for pulmonary stenosis, open surgery with valve replacement, balloon dilatation, or percutaneous stenting. (1) Interventions for pulmonary regurgitation are primarily surgical, either reconstruction of the RVOT conduit or replacement of the pulmonary valve through open surgery. The optimal timing of these interventions is not well understood.

Transcatheter pulmonary valve replacement offers a potentially less invasive treatment option for patients with prior surgery for congenital heart disease and RVOT dysfunction. It is possible that the use of less invasive valve replacement techniques can spare patients from multiple repeat open heart procedures over long periods of follow-up.

Description of Technology. The Melody transcatheter pulmonary valve and the Ensemble Transcatheter Valve Delivery System are used together for percutaneous replacement of a dysfunctional pulmonary valve. The Melody valve consists of a section of bovine jugular vein with an intact native venous valve. The valve and surrounding tissue is sutured within a platinum-iridium stent scaffolding. The transcatheter delivery system consists of a balloon-in-balloon catheter with a retractable sheath and distal cup into which the valve is placed. The procedure is performed on the beating heart without use of cardiopulmonary bypass.

The Melody valve is first crimped to fit into the delivery system. It is introduced through the femoral vein and advanced into the right side of the heart and put into place at the site of the pulmonary valve. The inner balloon is inflated to open up the artificial valve and then the outer balloon is inflated to position the valve into place.

The Melody transcatheter pulmonary valve and the Ensemble Transcatheter Valve Delivery System, manufactured by Medtronic Heart Valves, Inc (Santa Ana, CA), received FDA approval under the Humanitarian Device Exemption (HDE) Program on January 25, 2010. Approval was for use as an adjunct to surgery in the management of pediatric and adult patients with the following clinical conditions:

• Existence of a full (circumferential) RVOT conduit that was equal to or greater than 16mm in diameter when originally implanted, and
• Dysfunctional RVOT conduits with clinical indication for intervention, and either:

• Regurgitation: > moderate regurgitation, or
• Stenosis: mean RVOT gradient >35mm Hg

• High-risk for surgery based due to comcomitant medical commorbidities; or
• Poor surgical candidate due to multiple prior thoracotomies for open heart surgery.

Transcatheter pulmonary valve implantation is considered investigational for all other indications.

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

02/20/2013: Added the verbiage "when performed according to FDA-approved indications" to the medically necessary policy statement.

Covered Codes

This is not intended to be a comprehensive list of codes. Some covered procedure codes have multiple descriptions.

The code(s) listed below are ONLY covered if the procedure is performed according to the "Policy" section of this document. 

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