cpt 33477 - Transcatheter Pulmonary Valve Implantation

Coding Code Description CPT


33477 Transcatheter pulmonary valve implantation, percutaneous approach, including prestenting of the valve delivery site, when performed




Transcatheter Pulmonary Valve Implantation


Introduction

Congenital heart disease is a term that means a person was born with heart problems. These difficulties affect the heart’s function and structure. Congenital heart disease can range from mild, which may not need treatment, to severe, which often does. One congenital heart defect is known as right ventricular outflow tract (RVOT) dysfunction. Essentially, it’s a problem with how the blood flows as it leaves the heart and goes to the lungs. Repairing it requires reconstructing certain areas of the heart and placing a tube (conduit) to allow the blood to flow correctly. Over a long period of time the conduit can become narrowed or a specific valve can become leaky. A second valve replacement surgery may be needed in this situation. This second surgery is usually done as an open surgery. However, surgery using a long, thin tube (a heart catheter) instead of open heart surgery can be done in certain situations. This policy describes when an additional RVOT surgery using a catheter may be considered medically necessary.


Transcatheter pulmonary valve implantation (TPVI)

Transcatheter pulmonary valve implantation is considered medically necessary for patients with congenital heart disease and current right ventricular outflow tract obstruction (RVOT) or regurgitation including the following indications:
* Individuals with right ventricle-to-pulmonary artery conduit with or without bioprosthetic valve with at least moderate pulmonic regurgitation OR
* Individuals with native or patched RVOT with at least moderate pulmonic regurgitation OR
* Individuals with right ventricle-to-pulmonary artery conduit with or without bioprosthetic valve with pulmonic stenosis  (mean RVOT gradient at least 35 mm Hg) OR
* Individuals with native or patched RVOT with pulmonic stenosis (mean RVOT gradient at least 35 mm Hg). Transcatheter pulmonary valve implantation is considered investigational for all other indications.


Evidence Review Description

Transcatheter pulmonary valve implantation (TPVI) is a less invasive alternative to open surgical pulmonary valve replacement or reconstruction for right ventricular outflow tract (RVOT) obstruction. Percutaneous pulmonary valve replacement may be indicated for congenital pulmonary stenosis. Pulmonary stenosis or regurgitation in a patient with congenital heart disease (CHD) who has previously undergone RVOT surgery are additional indications. Patients with prior CHD repair are at risk of needing repeated reconstruction procedures.

Background

Congenital Heart Disease

Congenital heart disease, including tetralogy 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 using 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.

Because individuals with surgically corrected congenital heart disease are living into adulthood, 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.1

Treatment

Interventions for RVOT dysfunction often require numerous repeat open heart procedures for patients who live into adulthood. Treatment options for pulmonary stenosis are 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. The optimal timing of these interventions is not well understood.2

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

Summary of Evidence

For individuals who have a history of congenital heart disease (CHD) and current right  ventricular outflow tract (RVOT) obstruction who receive transcatheter pulmonary valveimplantation (TPVI) with a Food and Drug Administration (FDA)-approved device and indication, the evidence includes prospective, interventional, noncomparative studies and multiple prospective and retrospective case or cohort series. Relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, hospitalizations, and treatment-related morbidity and mortality. Results of the case series have indicated that there is a high rate of procedural success and low procedural mortality, although the rates of serious procedural adverse events reported ranges from 3.0% to 7.4%. Most valves have demonstrated competent functioning by Doppler echocardiography at 6- to 12-month follow-ups, but complications (eg, stent fractures, need for re-interventions) were reported in an FDA analysis to occur at rates of 18% and 7%, respectively. Other publications with longer follow-up have reported stent fractures in up to 26% of patients; however, most stent fractures did not required reintervention. Studies with follow-up extending to a maximum of 7 years postprocedure have suggested that the functional and hemodynamic improvements are durable, but a relatively high proportion of patients (20%-30%) have required reintervention on the pulmonary valve. No comparative studies were identified, and there is no direct evidence that TPVI reduces future open heart procedures. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have a history of CHD and current RVOT obstruction who receive TPVI with a non-FDA-approved device or indication, the evidence includes case series. Relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, hospitalizations, and treatment-related morbidity and mortality. There is limited evidence on the off-label use of TPVI, including the use of a non-FDA-approved valve, or use of an approved valve for a non-FDAapproved indication. The published case series enrolled relatively few patients and are heterogeneous regarding devices used and indications for TPVI. The evidence is insufficient to determine the effects of the technology on health outcomes.