BlueCross and BlueShield of Montana Medical Policy/Codes
Transcather Pulmonary Valve Implantation
Chapter: Surgery: Procedures
Current Effective Date: September 24, 2013
Original Effective Date: September 24, 2013
Publish Date: June 24, 2013
Description

Transcatheter pulmonary valve implantation (TPVI) is an alternative to pulmonary valve replacement by open surgery. It is 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 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 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. (1)

Interventions for RVOT dysfunction often require repeat open heart surgery, resulting in numerous open heart procedures in 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 through open surgery. The optimal timing of these interventions is not well understood. (2)

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.

Regulatory Status

The Melody transcatheter pulmonary valve and the Ensemble Transcatheter Valve Delivery System, manufactured by Medtronic Heart Valves, Inc (Santa Ana, CA), received U.S. Food and Drug Administration (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 16 mm in diameter when originally implanted, and
  • Dysfunctional RVOT conduits with clinical indication for intervention, and either:
    • Regurgitation: ≥moderate regurgitation, or
    • Stenosis: mean RVOT gradient ≥35 mm Hg.
Policy

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.

Medically Necessary

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.

Investigational

BCBSMT considers transcatheter pulmonary valve implantation experimental, investigational and unproven for all other indications.

Federal Mandate

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.

Rationale for Benefit Administration

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.

Rationale

The published literature on transcatheter pulmonary valve implantation (TPVI) consists of small case series, which generally report on short-term outcomes. Three of these publications reported on at least 100 patients, these are discussed as follows.

The multicenter US Melody TPV trial is a prospective uncontrolled trial from five clinical sites that was designed to study the safety, procedural success, and short-term effectiveness of the Melody transcatheter pulmonary valve. (2,3) This study was designed to follow 150 patients over a 5-year period. Eligibility criteria included a dysfunctional right ventricular outflow tract (RVOT) conduit or a dysfunctional bioprosthetic pulmonary valve, plus evidence of heart failure. For patients with New York Heart Association (NYHA) class I heart failure, a Doppler mean gradient of equal to or greater than 40 mm Hg or severe pulmonary regurgitation was required, and for patients with NYHA class II-IV heart failure, a mean gradient of equal to or greater than 35 mm Hg or moderate pulmonary regurgitation was required. These inclusion criteria generally were indications for pulmonary valve replacement. The primary outcomes were defined as procedural success, adverse events from the procedure, and effectiveness, as measured by the proportion of patients with acceptable valve function at 6 months.

Interim results from this trial have been published. (2,3) The most recent publication (2) reported on 136 patients who underwent attempted TPVI. A total of 124/136 patients (91.2%) had successful implantation. In 12 patients, implantation was not possible due to anatomic or other intra-procedural findings that precluded implantation. One death occurred as a result of the procedure (0.7%), and serious adverse events occurred in 8/136 patients (6%). Adverse events included coronary artery dissection, conduit rupture/tear, wide complex tachycardia, respiratory failure, femoral vein thrombosis, and perforation of the pulmonary artery.

A total of 94 patients had successful implantation and reached the 6-month follow-up time point at the time of publication. Acceptable valve function, defined as mild pulmonary regurgitation or less on echocardiography, was present in greater than 90% of patients. Right ventricular pressure and right ventricular outflow tract gradient improved following the procedure, and 71/94 (75.5%) were in NYHA class I heart failure at 6 months. Over the course of follow-up, stent fractures were diagnosed in 25/124 (20.2%) patients, and 9/124 (7.3%) required implantation of a second valve.

The FDA reviewed results from this trial in 99 patients enrolled between January 2007 and December 2008, and reported more detailed data on complications from the procedure (4). A total of 90 patients were deemed suitable for implantation following catheterization, and 87/90 patients had successful implantation. There was one procedural-related death (1.1%). The following table is adapted from the FDA summary of safety and probable benefit:

Device-related adverse effects (N=89 subjects)

Event

Subjects with Event

Freedom from event at 12mth (SE)

Stent fracture (all) 

16 (18%)

77.1% (7.5) 

Minor¹

11 (12%)

84.1% (6.7)

Major¹

5 (6%)

90.6% (5.2)

Valve stenosis

6 (7%)

90.5% (4.8)

Worsening tricuspid regurgitation   

1 (1%)

100% (--)

Reintervention²

 6 (7%)

93.5% (4.3)

Reoperation

1 (1%)

98.6% (2.2)

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.

Summary

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.

ICD-9 Codes
35.26, 429.4, 745.12, 745.2, 746.00-746.09, 996.71, V43.3
ICD-10 Codes

I97.0, I97.110, I97.130, I97.190, Q20.5, Q21.3, Q22.0-Q22.3, T82.01xA-T82.09xS, T82.221A-T82.228S, Z95.2-Z95.4, 02RH4JZ

Procedural Codes: 0262T
References
  1. Khambadkone S, Nordmeyer J, Bonhoeffer P. Percutaneous implantation of the pulmonary and aortic valves: indications and limitations. J Cardiovasc Med 2007; 8(1):57-61.
  2. McElhinney DB, Hellenbrand WE, Zahn EM et al. Short- and medium-term outcomes after transcatheter pulmonary valve placement in the expanded multicenter US Melody Valve Trial. Circulation 2010; 122(5):507-16.
  3. Zahn EM, Hellenbrand WE, Lock JE et al. Implantation of the Melody transcatheter pulmonary valve in patients with a dysfunctional right ventricular outflow tract conduit. J Am Coll Cardiol 2009; 54(18):1722-9.
  4. FDA summary of Safety and Probable Benefit. Melody® Transcatheter Pulmonary Valve and Ensemble® Transcatheter Valve Delivery System. Available online at: http://www.accessdata.fda.gov. Last accessed August 2012.
  5. Lurz P, Coats L, Khambadkone S et al. Percutaneous pulmonary valve implantation: Impact of evolving technology and learning curve on clinical outcomes. Circulation 2008; 117(15):1964-72.
  6. Eicken A, Ewert P, Hager A et al. Percutaneous pulmonary valve implantation: two-centre experience with more than 100 patients. European Heart J 2011; 32(10):1260-5.
  7. Vezmar M, Chaturvedi R, Lee KJ et al. Percutaneous pulmonary valve implantation in the young 2-year follow-up. JACC Cardiovasc Interv 2010; 3(4):439-48.
  8. Nordmeyer J, Coats L, Bonhoeffer P. Current experience with percutaneous pulmonary valve implantation. Semin Thorac Cardiovasc Surg 2006; 18(2):122-5.
  9. Khambadkone S, Coats L, Taylor A et al. Percutaneous pulmonary valve implantation in humans: results in 59 consecutive patients. Circulation 2005; 112(8):1189-97.
  10. Momenah TS, El Oakley R, Al Najashi K et al. Extended application of percutaneous pulmonary valve implantation. J Am Coll Cardiol 2009; 53(20):1859-63.
  11. Nordmeyer J, Coats L, Lurz P et al. Percutaneous pulmonary valve-in-valve implantation: a successful treatment concept for early device failure. Eur Heart J 2008; 29(6):810-15.
  12. Transcatheter Pulmonary Valve Implantation. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2011 November) Surgery 7.01.131.
History
June 2013  New 2013 BCBSMT medical policy.
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Transcather Pulmonary Valve Implantation