Prior authorization is recommended. Call Blue Cross and Blue Shield of Montana (BCBSMT) Customer Service at 1-800-447-7828 or fax your request to the Medical Review Department at 406-441-4624. A retrospective review is performed if services are not prior authorized.
BCBSMT may consider transcatheter pulmonary valve implantation (TPVI) 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:
- High-risk for surgery due to concomitant medical comorbidities; or
- Poor surgical candidate due to multiple prior thoracotomies for open heart surgery.
BCBSMT considers transcatheter pulmonary valve implantation experimental, investigational and unproven for all other indications.
Federal mandate prohibits denial of any drug, device, or biological product fully approved by the FDA as investigational for the Federal Employee Program (FEP). In these instances coverage of these FDA-approved technologies are reviewed on the basis of medical necessity alone.
This medical policy was developed through consideration of peer reviewed medical literature, FDA approval status, accepted standards of medical practice in Montana, Technology Evaluation Center evaluations, and the concept of medical necessity. BCBSMT reserves the right to make exceptions to policy that benefit the member when advances in technology or new medical information become available.
The purpose of medical policy is to guide coverage decisions and is not intended to influence treatment decisions. Providers are expected to make treatment decisions based on their medical judgment. Blue Cross and Blue Shield of Montana recognizes the rapidly changing nature of technological development and welcomes provider feedback on all medical policies.
When using this policy to determine whether a service, supply or device will be covered, please note that member contract language will take precedence over medical policy when there is a conflict.
1 Stent fractures that did not require intervention were defined as minor; those that required reintervention were defined as major.
2 Reinterventions were balloon angioplasty in one patient; repeat implantation of a second TPV in 5 patients.
There were 64 patients in the FDA analysis who reached 6 months of follow-up. Of these, 56/64 (87.5%) had acceptable hemodynamic function of the valve by Doppler echocardiography. At 6 months, approximately 75% of patients were in NYHA class I, and 25% were in NYHA class II. Pulmonary regurgitation that was mild or worse was present in 6.2% of patients.
Lurz et al. (5) reported on 163 patients who underwent attempted TPVI from 4 clinical centers in Europe. Eligibility for the procedure included elevated right ventricular (RV) systolic pressure, increased RVOT dimensions, and either symptoms or evidence of severe RV dysfunction. Procedural success was achieved in 155/163 patients (95.1%). Procedural complications occurred in 12/163 (7.4%), 8 of which were considered serious and 5 of which required open surgery.
The median follow-up was 28.4 months. Over the course of follow-up, 4/155 patients (2.6%) died, and an additional 5/155 patients (3.2%) developed infective endocarditis. At 12 months’ follow-up, greater than 90% of patients had absent or mild valve dysfunction as measured by echocardiography.
Eicken et al. (6) reported on 102 consecutive patients (mean age 21.5 years) undergoing transcatheter pulmonary valve implantation at 2 centers in Germany. Eligibility for the procedure included RVOT dysfunction with evidence of RV compromise or increased RV pressure. There was one death (1.0%) that occurred as a result of compression of the left coronary artery. Two patients (2.0%) had evidence of stent fracture immediately post-procedure, and one additional patient (1.0%) developed infective endocarditis at 6 months’ follow-up. At a median follow-up of 357 days, there was a significant decrease in the RVOT gradient from a median of 36 mm Hg to 15 mm Hg (p<0.0001). However, there was no significant change in exercise capacity as measures by maximal oxygen uptake.
Other case series reported on smaller numbers of patients, with patient populations ranging from 7-59. (7-11) These publications reported generally similar results as the larger series, with high procedural success and relatively low rates of serious complications. One of these trials reports follow-up for up to 2 years; no studies were identified that provide longer follow-up data.
Transcatheter pulmonary valve implantation received FDA approval under the Humanitarian Device Exception program in January 2010 for patients with previous repair of congenital heart disease and right ventricular outflow tract (RVOT) obstruction. There is currently a lack of high-quality evidence evaluating outcomes of this procedure for the indicated population. No randomized controlled trials (RCTs) have been performed, and there are no controlled trials that compare transcatheter valve implantation to available alternatives. The available evidence consists of case series of patients with RVOT dysfunction who require re-intervention.
The results of the case series indicate that there is a high rate of procedural success and low procedural mortality. The rate of serious procedural adverse events reported in these series ranges from 3.0-7.4%. At 6-12 months of follow-up, there is evidence that the majority of valves demonstrate competent functioning by Doppler echocardiography, with the majority of patients in NYHA functional class I or II. Complications at 6 months’ follow-up, such as stent fractures and the need for re-interventions, were reported by the FDA analysis to occur at rates of 18% and 7%, respectively. There is no direct evidence to demonstrate that TPV implantation leads to a reduction in future open heart procedures.
In patients who are not candidates for open surgery, or who are at high-risk for surgery due to other medical comorbidities, alternative treatment options are limited. Based on the evidence on short-term success, TPVI can be considered medically necessary for patients who are not candidates for open repair or who are high risk for open repair. For all other indications, TPVI is considered experimental, investigational and unproven.