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DESCRIPTIONTranscatheter pulmonary valve implantation (TPVI) is an alternative to pulmonary valve replacement by open surgery. It intended for patients who have previously had a pulmonary valve repair for congenital heart disease, in whom dysfunction of the repaired valve necessitates further intervention.
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 surgically corrected 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. 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 Edwards SAPIEN Pulmonic Transcatheter Heart Valve, composed of a stainless steel frame with bovine pericardial tissue leaflets and available in 23 and 26 mm sizes, is CE-marked for use in Europe, but does not have FDA- approval for use in the United States.
The Melody® transcatheter pulmonary valve and the Ensemble® Transcatheter Valve Delivery System, manufactured by Medtronic Inc. (Minneapolis, MN), 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:
POLICYTranscatheter pulmonary valve implantation, when performed according to FDA-approved indications, is considered medically necessary for patients with prior repair of congenital heart disease and right ventricular outflow tract (RVOT) dysfunction, who are not good candidates for open repair due to one or more of the following conditions:
Transcatheter pulmonary valve implantation is considered investigational for all other indications.
POLICY GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY03/22/2012: Approved by Medical Policy Advisory Committee.
02/20/2013: Added the verbiage "when performed according to FDA-approved indications" to the medically necessary policy statement.
03/05/2014: Policy reviewed; no changes.
12/22/2014: Policy reviewed; description updated regarding devices. Policy statement unchanged.
SOURCE(S)Blue Cross Blue Shield Association policy # 7.01.131
This may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.