Effective Date:

A)   This policy will apply to all services performed on or after the above revision date which will become the new effective date.

B)   For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Transcatheter pulmonary valve implantation requires preauthorization.

2)    This procedure is an alternative to open heart surgery in patients with previous repair of congenital heart disease and right ventricular outflow tract obstruction.

1)    QualChoice considers Transcatheter pulmonary valve implantation using FDA-approved devices (e.g., Melody Transcatheter Pulmonary Valve) medically necessary in patients with prior repair of congenital heart disease  (Z87.74) for the treatment of dysfunctional right ventricular outflow tract (RVOT) conduits whose pulmonary valve has become stenotic (mean RVOT gradient greater than or equal to 35 mm Hg) or regurgitant (moderate or more severe regurgitation), where individuals indicated for the procedure have a full circumferential RVOT conduit greater than or equal to 16 mm in diameter when originally implanted.

2)    Any other use of TPVI is considered experimental and investigational, and is not covered.

Codes Used in This BI:

0262T   Implantation of catheter-delivered prosthetic pulmonary valve, endovascular

            approach. (deleted 1-1-16)

33477   Transcatheter pulmonary valve implantation, percutaneous approach

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. The goal of Transcatheter pulmonary valve implantation, at a minimum, is to improve the hemodynamic function of the existing conduit, mitigate the adverse impact of pulmonary regurgitation and/or RVOT obstruction, and extend the longevity of the existing conduit and defer the need for conduit replacement. In some patients delaying surgical conduit re-intervention may reduce the need for open heart surgeries required over the course of a lifetime. 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 six 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.

The Melody U.S. Clinical Trial (n=34) was designed to evaluate the safety, procedural success, and short-term effectiveness of the Melody Transcatheter pulmonary valve in patients with dysfunctional right ventricular outflow tract conduits. Early results were published by Zahn et al. (2009). Patients underwent catheterization for intended Melody valve implantation at three centers between January and September, 2007. The mean age was 19.4 ± 7.7 years. Doppler mean gradient was 28.8 ± 10.1 mm Hg, and 94% of patients had moderate or severe pulmonary regurgitation (PR). Implantation was successful in 29 of 30 attempts, and not attempted in four patients. Complications included one conduit rupture requiring urgent surgery and device removal, one distal pulmonary artery guide wire perforation, and one instance of wide complex tachycardia. Peak systolic conduit gradient fell from 37.2 ± 16.3 mm Hg to 17.3 ± 7.3 mm Hg. None of the patients had more than mild PR. At 6-months, conduit Doppler mean gradient was 22.4± 8.1 mm Hg, and pulmonary regurgitation fraction as measured by magnetic resonance imaging was significantly improved (3.3 ± 3.6% vs. 27.6 ± 13.3%, p<0.0001). Stent fracture occurred in 8 of 29 implants. Three of these patients were subsequently treated with a second Melody valve for recurrent stenosis during follow-up. The authors concluded that implantation of the Melody valve for RVOT conduit dysfunction can be performed by experiences operators and appears safe, and has encouraging acute and short-term outcomes. Longer follow-up and a larger patient experience are needed to determine the ultimate role of this therapy in the treatment of conduit dysfunction.

McElhinney et al. (2010) evaluated short and medium-term outcomes in the expanded Melody U.S. Trial (n=136). Implantation was attempted in 124 patients, and was achieved successfully in all except one. Placement was not attempted in the other 12 patients due to the risk of coronary artery compression (n=6) or other clinical or protocol contraindications. There was one death from intracranial hemorrhage after coronary artery dissection, and one valve was explanted after conduit rupture. The median peak RVOT gradient was 37 mm Hg prior to implantation and 12 mm Hg immediately following implantation. Pulmonary regurgitation (PR) was moderate or severe in 92 patients prior to implantation, and no patient had greater than mild PR immediately after implantation or during follow-up (≥ one year in 65 patients). Freedom from stent fracture was 77.8% ± 4.3% at 14 months, and freedom from Melody valve dysfunction or re-intervention was 93.5 ± 2.4% at one year. A higher RVOT gradient at discharge and younger age were associated with shorter freedom from dysfunction.

Eiken et al. (2011) published results of 102 consecutive percutaneous pulmonary valve implantations performed at two centers in Germany between 2006 and 2010. The median patient age was 21.5 years. Sixty-one patients had undergone surgical correction of a Tetralogy of Fallot/pulmonary atresia with ventricular septal defect, and14 had a common arterial trunk; the remaining patients had been treated surgically for transposition of the great arteries (n=9) or aortic stenosis (n=8), or had a variety of other cardiac lesions (n=10). The majority of conduits (79) used during previous surgery were homograft’s. The median peak systolic RVOT gradient between the right ventricle and the pulmonary artery decreased immediately following the procedure from 37 mmHg (29–46 mmHg) to 14 mmHg (9–17 mmHg, p< 0.001). Pulmonary regurgitation assessed by MRI was reduced from a median of 16% (5–26%) to 1% (0–2%, p<0.001). The median end-diastolic RV-volume index also decreased significantly (p=0.001). One patient died due to compression of the left coronary artery. At a median follow-up of 357 days (99–388 days), the mean doppler gradient in the RVOT decreased from a pre-procedure median of 36 mmHg (26–44) to a median of 15 mmHg (12–20) at the latest follow-up (p<0.0001). The authors concluded that PPVI can be performed by an experienced structural heart disease internationalist in patients with RVOT dysfunction. Medium and long term follow up needs to be assessed to document sustained benefit, however. It remains to be proved whether the improvements in hemodynamics persist, and the goal to reduce the number of cardiothoracic operations during the lifetime of the patient can be achieved.

The National Institute for Health and Clinical Excellence (NICE) (UK) Interventional Procedure Guidance on percutaneous pulmonary valve implantation for right ventricular outflow tract (RVOT) dysfunction issued in 2007 states that the evidence is limited to small numbers of patients but shows good short-term efficacy. There is little evidence on long-term efficacy. There are no particular safety concerns in the context of a condition that otherwise requires open cardiac surgery. Clinicians wishing to use this procedure should do so only with special arrangements for clinical governance, consent and for audit or research.

Eiken A, Ewert P, Hager A, Peters B, Fratz S, Kuehne T, et al. Percutaneous pulmonary valve implantation: two-centre experience with more than 100 patients. Eur Heart J. 2011 May; 32(10):1260-5. Epub 2011 Jan 27.

U.S. Food and Drug Administration Device Approvals and Clearances. Humanitarian Device Approval, Medtronic Melody® Transcatheter Pulmonary Valve - H080002. Available at URL address: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm199258.htm

McElhinney DB, Hellenbrand WE, Zahn EM, Jones TK, Cheatham JP, Lock JE, Vincent JA. Short- and medium-term outcomes after Transcatheter pulmonary valve placement in the expanded multicenter US melody valve trial. Circulation. 2010 Aug 3; 122(5):507-16. Epub 2010 Jul 19.

National Institute for Health and Clinical Excellence. Interventional procedure guidance 266. Transcatheter aortic valve implantation for aortic stenosis. UK: NICE; 2008 Jun.