Medical Policies - Surgery


Transcatheter Pulmonary Valve Implantation

Number:SUR707.029

Effective Date:10-15-2017

Coverage:

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Transcatheter pulmonary valve implantation (TPVI) may be 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:

High-risk for surgery due to concomitant medical comorbidities; or

Poor surgical candidate due to multiple prior thoracotomies for open heart surgery.

Transcatheter pulmonary valve implantation is considered experimental, investigational and/or unproven for all other indications.

Description:

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 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. (1)

Interventions for RVOT dysfunction often require repeat open heart surgery, resulting in numerous 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 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.

The Edwards SAPIEN Pulmonic Transcatheter Heart Valve, composed of a stainless steel frame with bovine pericardial tissue leaflets and is available in 23 and 26 mm sizes, is CE-marked for use in Europe, but does not have Food and Drug Administration approval for use in the United States.

Regulatory Status

On January 25, 2010, the Melody® transcatheter pulmonary valve and the Ensemble® Transcatheter Valve Delivery System (Medtronic, Minneapolis, MN) were approved by the U.S. Food and Drug Administration (FDA) under the Humanitarian Device Exemption Program. 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) right ventricular outflow tract (RVOT)conduit that was 16 mm or greater in diameter when originally implanted; and

Dysfunctional RVOT conduits with clinical indication for intervention, and either:

o Regurgitation: ≥ moderate regurgitation, or

o Stenosis: mean RVOT gradient ≥35 mm Hg.

In 2015, approval of the Melody device was amended to a premarket approval (PMA) because the FDA determined that the device represents a breakthrough technology. (3) The PMA was based, in part, on 2 prospective clinical studies, the Melody TPV Long-term Follow-up Post Approval Study (PAS) and the Melody TPV New Enrollment PAS. FDA product code: NPV.

Rationale:

The published literature on transcatheter pulmonary valve implantation (TPVI) consists of small case series, which generally report on short-term outcomes. Some of the larger, representative publications are discussed in this literature review.

Studies Using Valves Approved by the U.S. Food and Drug Administration

The only device that currently has U.S. Food and Drug Administration (FDA) approval for TPVI is the Melody™ valve (Medtronic, Minneapolis, MN). Approved indications include right ventricular outflow tract (RVOT) dysfunction, defined as pulmonic regurgitation (moderate or greater) or pulmonic stenosis (mean gradient, ≥35 mm Hg). In addition, a circumferential RVOT conduit should exist that is 16 mm or greater in diameter when originally implanted.

U.S. Melody TPV Trial

The multicenter U.S. Melody TPV trial is a prospective uncontrolled trial from 5 clinical sites that was designed to study the safety, procedural success, and short-term effectiveness of the Melody transcatheter pulmonary valve. (2,4) This was the pivotal trial on which FDA approval for the Melody valve was based. The study was designed to follow 150 patients over a 5-year period. Eligibility criteria included a dysfunctional 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 40 mm Hg or greater or severe pulmonary regurgitation was required, and for patients with NYHA class II-IV heart failure, a mean gradient of 35 mm Hg or greater 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 (AEs) from the procedure, and effectiveness, as measured by the proportion of patients with acceptable valve function at 6 months.

Results from this trial have been published in several reports. (2,4,5) Short- and medium-term outcomes for 136 patients who underwent attempted TPVI were reported by McElhinney et al. in 2010. (2) A total of 124 of 136 patients (91.2%) had successful implantation. In 12 patients, implantation was not possible due to anatomic or other intraprocedural findings that precluded implantation. One death occurred as a result of the procedure (0.7%), and serious AEs occurred in 8 of 136 patients (6%). AEs 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 (RV) pressure and RV outflow tract gradient improved following the procedure, and 71 of 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 of 124 (20.2%) patients, and 9 of 124 (7.3%) required implantation of a second valve.

Cheatham et al. reported on outcomes up to 7 years following TPVI for the 148 patients who received and were discharged with a TPV in the Melody TPV trial (of 171 patients enrolled). (5) Of the 171 patients enrolled, 167 underwent catheterization, 150 had a Melody valve implanted, and 148 of those survived to discharge with the Melody valve in place. On echocardiogram at discharge, pulmonary regurgitation was absent/trivial or mild in 140 patients and 5 patients, respectively, which represented a significant improvement from baseline. Over a median follow-up of 4.5 years (range, 0.4-7.0 years), 4 deaths occurred. During the follow-up period, 32 patients required a reintervention on RV outflow tract, 25 of which were transcatheter TPV reinterventions. A total of 11 patients required Melody valve explantation. Among the 113 patients who were alive and free from reintervention a median of 4.5 years after implantation, the most recent RVOT gradient was unchanged from early after valve implantation. Functional outcomes generally improved during the study: before TPVI, 14% of patients were in NYHA class I and 17% were in class III or IV. At every postimplantation annual evaluation, at least 74% of patients were in class I and no more than 1% to 2% were in class III or IV.

A secondary publication from the U.S. Melody TPV trial focused on the change in exercise function following TPVI. (6) Patients completed a standardized cardiopulmonary regimen 2 months before TPVI and 6 months following TPVI. Results of pre- and postexercise parameters were available for 94 to 114 patients, depending on the specific outcome. There were numerous physiologic outcome measures reported, with some of these showing a statistically significant change between the 2 time points, and others not showing a significant change. For example, there was a significant increase in the percent predicted maximal workload from 65.0% at baseline to 68.3% at follow-up (p<0.001) and a significant decrease in the ratio of minute ventilation to CO2 production from 30.8 at baseline to 29.1 at follow-up (p<0.001). In contrast, there were no significant changes in peak oxygen consumption or in spirometric measures of pulmonary function. This study reports modest benefits in exercise parameters for patients treated with TPVI. The results are limited by the lack of a control group and by the large number of patients who did not have completed exercise results available (approximately one-third of total).

Melody Transcatheter Pulmonary Valve Postapproval Study

Armstrong et al. published 1-year follow-up results of the Melody TPVI postapproval study (PAS), a prospective study designed to evaluate the short-term hemodynamic changes following device implantation. (7) The study used historical controls from the Melody IDE trial (described above) to investigate whether the short-term effectiveness of the device was noninferior to results shown in the IDE trial. The study enrolled 120 subjects, 101 of whom underwent attempted TPVI. Patient selection was based on the criteria used in the IDE trial, but did not include the age (≥5 years of age) and weight (≥30 kg) limitations. Procedure-related significant AEs occurred in 16 patients (13.3% of total cohort of 120; 15.8% of those who had an attempted TPVI), the most common of which was a confined conduit tear. Procedural success occurred in 99 subjects (98% of those with an attempted TPVI). At 1-year follow-up, the proportion of patients in NYHA class I heart failure increased from 35% at baseline to 89%. Of the 99 patients implanted for at least 24 hours, 87 had acceptable TPV hemodynamic function confirmed at 6 months (96.7% of those with evaluable echocardiographic data, 87.9% of entire cohort) and 82 had acceptable TPV hemodynamic function at 1 year (94.3% of those with evaluable echocardiographic data, 82.8% of the entire cohort). Following the procedural period, serious device-related AEs occurred in 8%, most commonly endocarditis (n=3 patients).

Gillespie et al. evaluated results of TPVI after a Ross procedure in a retrospective review of pooled findings from the Melody TPV trial and postapproval study and an additional European registry, the manufacturer-sponsored Melody TPV Post-Market Surveillance Study which was conducted in Canada and Europe (NCT00688571). (8) In the pooled sample (N=358), 67 (19%) had a prior Ross procedure. A Melody valve was successfully implanted in 56 of 67 (84%) of the Ross patients who underwent catheterization with intent for TPVI. Six patients (9%) had symptomatic coronary artery compression after TPVI or did not undergo implantation due to the risk of compression. RV hemodynamics generally improved after TPVI, but RVOT reinterventions were required in 12 of 55 patients who were discharged from the implant hospitalization with the Melody valve in place.

Additional Noncomparative Studies

A number of publications have reported on series of patients treated with TPVI. Some of the larger series are discussed in detail.

Lurz et al. (9) reported on 163 patients who underwent attempted TPVI from 4 clinical centers in Europe. Eligibility for the procedure included elevated RV systolic pressure, increased RVOT dimensions, and either symptoms or evidence of severe RV dysfunction. Procedural success was achieved in 155 of 163 patients (95.1%). Procedural complications occurred in 12 of 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 of 155 patients (2.6%) died, and an additional 5 of 155 patients (3.2%) developed infective endocarditis. At 12-month follow-up, greater than 90% of patients had absent or mild valve dysfunction as measured by echocardiography.

Eicken et al. (10) reported on 102 consecutive patients (mean age, 21.5 years) undergoing TPVI at 2 centers in Germany. Eligibility for the procedure included RVOT dysfunction with evidence of RV compromise or increased RV pressure. There was 1 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 postprocedure, and 1 additional patient (1.0%) developed infective endocarditis at 6-month follow-up. At a median follow-up of 357 days, there was a significant decrease in the RVOT gradient from a median of 36 to 15 mm Hg (p<0.001). 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 to 64. (11-18) These publications reported generally similar results as the larger series, with high procedural success and relatively low rates of serious complications. The longest follow-up was reported by Borik et al., who evaluated 51 patients who underwent TPVI with the Melody valve at a single institution. (19) Over a mean follow-up of 4.5 years (range, 0.9-6.9 years), freedom from any reintervention was 87% and 68% at 3 and 5 years, respectively, and freedom from surgery was 90% at 5 years. Overall, RV functional parameters did not change with longer follow-up.

Section Summary: Studies Using Valves Approved by the U.S. Food and Drug Administration The evidence for the use of TPVI with the Melody valve consists of the prospective, interventional, noncomparative pivotal study on which the device’s FDA approval was based, along with a postapproval registry study and a number of additional case series. Overall, the evidence suggests that TPVI is associated with high rates of short-term technical success and improvements in heart failure-related symptoms and hemodynamic parameters. Studies with follow-up extending to a maximum of 7 years postprocedure suggest that the functional and hemodynamic improvements are durable, but a relatively high proportion of patients (approximately 20%-30%) require reintervention on the pulmonary valve.

Non-FDA-Approved Uses of TPVI

There are a variety of potential off-label uses of TPVI that have been reported in the literature. These include use of devices that are not FDA-approved, and use of approved devices for non-FDA-approved indications.

Non-FDA-Approved Indications

A few case series have been reported on use of the Melody valve in patients with clinical characteristics that do not correspond to FDA-approved indications. (20,21) These have included use in valves other than the pulmonic position, patients with conduit sizes that do not correspond to the FDA indications, and patients with prior congenital heart repair surgery that did not involve construction of a RVOT conduit. In general, these case series have reported high rates of procedural success with low rates of periprocedural complications, but evidence on longer term outcomes is lacking.

Although most studies have evaluated the use of TPV implantation in patients with a constructed RVOT conduit, a few studies have evaluated TPV implantation with either the Melody or Edwards SAPIEN pulmonary valve in a native RVOT or RVOT without a circumferential conduit. Meadows et al. reported results from a retrospective, 5-center review of patients who underwent TPV placement in a nonconduit RVOT, with native tissue comprising at least part of the circumference. (22) Thirty-one patients were included, with indications for RVOT intervention including primarily valvular insufficiency in 14 (45%), obstruction in 3 (10%), and mixed obstruction and insufficiency in 14 (45%). TPV implantation was successful in all patients, but serious complications occurred in 2 patients (6%). At a median follow-up of 15 months (range, 1 month-3.8 years), all patients were alive, and no patient had greater than mild pulmonary regurgitation. Among the 19 patients with adequate imaging at follow-up, 6 (32%) had evidence of stent fracture. Three patients were treated for endocarditis or bloodstream infection. Malekzadeh-Milani reported outcomes for 34 patients with a native or patched noncircular RVOT who underwent Melody TPV insertion at a single center. (23) The procedure was technically successful in all patients, although early complications occurred in 8.8%. At a mean follow-up of 2.6 years, no patients had stent fracture or stent migration, and 32/34 (94.1%) had absent or trivial pulmonary regurgitation.

Several other small case series by Demkow et al. (N=10 patients) and Odemis et al. (N=7 patients) report on the use of the Edwards SAPIEN pulmonary valve for noncircumferential RVOT patch and large-diameter conduits, respectively. (24,25) The authors report high rates of successful valve implantation, but long-term follow-up is not reported.

Non-FDA-Approved Devices

A small number of retrospective, comparative studies have compared outcomes of the Edwards SAPIEN® pulmonic valve with the Melody® pulmonic valve. Boshoff et al. described the off-label uses in 21 patients treated with the Melody valve and 2 patients treated with the Edwards SAPIEN® pulmonic valve. (21) These included use in native RVOT obstruction, in conduits that were smaller than the FDA-labeled indications, and in large RVOT with a dynamic outflow aneurysm. There were no deaths or major procedural complications reported for these patients. Clinical outcome data were lacking or very limited in this publication.

Faza et al. reported on 20 patients who underwent successful implantation of the Edwards SAPIEN® pulmonic valve at 1 clinical center. (26) There were no periprocedural deaths, and all but 1 patient had no or trivial pulmonic regurgitation on latest follow-up. A comparison of hemodynamic parameters in these 20 patients was made with 13 patients who were treated with the Melody valve. Immediately following the procedure, the transvalvular gradient was similar between groups. At last follow-up, the mean residual transvalvular gradient was higher for patients receiving the SAPIEN® valve (18.4 mm Hg vs 11.2 mm Hg, p=0.016), but this difference was no longer present when patients were matched for length of follow-up.

A few other small case series reporting on the use of the Edwards SAPIEN® Pulmonic Valve for RVOT obstruction have been published. (24,25,27,28) For example, Kenny et al. reported on a phase 1 multicenter study of the Sapien pulmonic valve in 36 patients from 4 clinical centers. (28) Procedural success was reported in 97% of patients. Procedural complications occurred in 19% of patients (7/36), including valve migration (n=3), pulmonary hemorrhage (n=2), ventricular fibrillation (n=1), and stent migration (n=1). At 6-month follow-up, there were no deaths and 75% of patients (27/36) were in NYHA class I, compared with 14% at baseline. Freedom from reintervention at 6 months was 97%.

Adverse Events (AEs)

In addition to the AEs reported in the case series, several publications have focused on AEs following TPVI.

The FDA reviewed results from the U.S. Melody TPV trial as part of the FDA approval process and reported detailed data on complications from the procedure. (29) At that time, data were available for 99 patients enrolled between January 2007 and December 2008. A total of 90 patients were deemed suitable for implantation following catheterization, and 87 of 90 patients had successful implantation. There was 1 procedural-related death (1.1%). Table 1 is adapted from the FDA summary of safety and probable benefit.

Table 1. 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)

Minora

11 (12%)

84.1% (6.7)

Majora

5 (6%)

90.6% (5.2)

Valve stenosis

6 (7%)

90.5% (4.8)

Worsening tricuspid regurgitation

1 (1%)

100% (--)

Reinterventionb

6 (7%)

93.5% (4.3)

Reoperation

1 (1%)

98.6% (2.2)

a Stent fractures that did not require intervention were defined as minor; those that required reintervention were defined as major.

b 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 of 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.

Another publication focusing on AEs in the U.S. Melody TPV trial was published in 2011. (30) This publication reported on AEs at a median follow-up of 30 months in 150 patients. Stent fracture occurred in 26% (39/150) of patients. The estimated freedom from stent fracture was 77% at 14 months and 60% at 39 months. Freedom from reinterventions for all patients was estimated to be 86% at 27 months, and freedom from reinterventions for patients with stent fracture was estimated at 49% at 2 years.

McElhinney reported rates of infective endocarditis from 3 prospective cases series enrolling a total of 311 patients followed for a median of 2.5 years. (31) There were a total of 16 patients (5.1%) diagnosed with endocarditis at any location and 6 patients (1.9%) who had endocarditis at the pulmonic valve location. This corresponded to an annualized rate of pulmonic valve endocarditis of 0.88% per patient-year. Malekzadeh-Milani et al. evaluated patients with right-sided infective endocarditis at a single center to evaluate endocarditis rates in patients with TPVs compared with surgically-paced pulmonary valves. (32) Thirty-one patients with right-sided endocarditis and pulmonary valve implantation for congenital heart disease were included. Rates of endocarditis were 1.2 and 3.9 cases/100 person-years in patients with surgically-implanted valves and TPVs, respectively (p=0.03).

Boudjemline et al. conducted a prospective observational study to evaluate predictors of conduit rupture during the preparation of the RVOT for TPVI in a cohort of patients older than age 5 years with RVOT obstruction, pulmonary regurgitation, or mixed lesions, who underwent transcatheter therapies, including balloon dilatation, bare metal stent placement, or TPV placement. (33) Ninety-nine patients were included, 56 of whom were adults. Of the total cohort, 83.8% underwent Melody TPV implantation. Conduit rupture occurred in 9 patients (9.09%). In 2 of the 9 patients, conduit rupture was angiographically obvious and severe with extension, causing hemodynamic instability. All conduit ruptures occurred during balloon dilatation, and all occurred in patients with RVOT obstruction. Heavy calcification and the presence of a homograft were associated with conduit rupture risk.

Coronary artery compression during balloon angioplasty or stent placement in the RVOT conduit is considered a relative contraindication to TPV placement. Several studies have evaluated incidence of coronary artery compression. Morray et al. reported the incidence of coronary artery compression in a 4- center series of 404 patients who underwent attempted TPV implantation. (34) Three hundred forty-three patients (85% of total) underwent TPV implantation, and 21 patients (5% of total) had evidence of coronary artery compression. Most patients (n=19) with coronary artery compression did not undergo TPV placement. Using the same cohort reported in the Boudjemline et al. study, Fraisse et al. reported the incidence, diagnosis, and outcome of coronary compression among patients treated with transcatheter RVOT interventions for RVOT obstruction, pulmonary regurgitation, or mixed lesions. (35) All patients underwent balloon dilatation and coronary assessment with angiography, which was followed by TPV placement if there was ongoing RVOT dysfunction. Of 100 patients evaluated, 83% had implantation of a Melody TPV. Coronary artery compression occurred in 6 cases, all of which could be diagnosed by selective coronary angiogram and/or aortic root angiogram during balloon dilation of the RVOT. No specific risk factors for coronary artery compression were identified.

Van Dijck et al. compared rates of infective endocarditis between transcatheter pulmonary valves and surgically implanted pulmonary valves in a retrospective, single-center study which included 677 patients (738 conduits). (36) Patients who underwent procedures from 1989 to 2013 were included. A total of 107 Melody conduits were implanted in 107 patients. A total of 577 pulmonary valve cryopreserved homografts were implanted in 517 patients, and 54 Contegra grafts were implanted in 53 patients. Freedom from infective endocarditis at 5 years by Kaplan-Meier analysis was 84.9%, 87.8%, and 98.7% for patients with Melody conduits, Contegra grafts, or cryopreserved homografts, respectively.

Malekzadeh-Milani et al. reported on the incidence of infective endocarditis among 86 prospectively enrolled consecutive patients who underwent TPVI with the Melody valve. (37) Over a mean follow-up of 23.6 months (range, 2.6-28.3 months) after Melody implantation, 5 patients developed infective endocarditis (5.8%; 95% confidence interval [CI], 0.9% to 10.7%). Factors related to demographics, conduit type, procedural success, residual gradient, and duration of Melody valve implantation did not differ significantly between patients who did or did not develop infective endocarditis. Patients with infective endocarditis were more likely to have undergone invasive procedures after TPVI without antibiotic prophylaxis (odds ratio, 13.69; 95% CI, 1.98 to 94.52; p=0.014), and aspirin use was preventive for infective endocarditis (relative risk, 20.1; 95% CI, 3.34 to 120.9; p=0.001), although confidence intervals around risk estimates for both factors were wide.

Ongoing and Unpublished Clinical Trials

Some currently unpublished trials that might influence this review are listed in Table 2.

Table 2. Summary of Key Trials

NCT No.

Trial Name

Planned Enrollment

Completion Date

Ongoing

NCT00740870a

Implantation of the Medtronic Melody Transcatheter Pulmonary Valve in Patients With Dysfunctional RVOT Conduits: A Feasibility Study

150

Aug 2015

NCT00676689a

Implantation of the SAPIEN Transcatheter Heart Valve (THV) in the Pulmonic Position

70

Nov 2019

NCT: national clinical trial.

a Denotes industry-sponsored or cosponsored trial.

Summary of Evidence

The evidence for TPVI with an FDA-approved device according to FDA indications in patients who have a history of CHD and current RVOT includes 1 prospective, interventional, noncomparative study and multiple prospective and retrospective case series. Relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, hospitalizations, and treatment-related morbidity and mortality. 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% to 7.4%. At 6- to 12-month follow-up, there is evidence that most valves demonstrate competent functioning by Doppler echocardiography, with most patients in New York Heart Association functional class I or II. Complications at 6-month follow-up (e.g., stent fractures, need for reinterventions) 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 have not required reintervention. Studies with follow-up extending to a maximum of 7 years postprocedure suggest that the functional and hemodynamic improvements are durable, but a relatively high proportion of patients (approximately 20%-30%) require reintervention on the pulmonary valve.

The evidence for TPVI with a non-FDA-approved indication or device in patients who have a history of CHD and current RVOT includes case series. Relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, hospitalizations, and treatment-related morbidity and mortality. There is currently limited published evidence on the off-label use of TPVI, including implantation of a non-FDA-approved valve, or use of an approved valve for a non-FDA-approved indication. The published evidence consists of relatively small case series that are heterogeneous in terms of the device used and the indications for TPVI. The evidence is insufficient to determine the effects of the technology on health outcomes.

Practice Guidelines and Position Statements

In 2014, American Heart Association (AHA) and American College of Cardiology (ACC) issued guidelines for the management of patients with valvular disease. These guidelines do not make specific recommendations regarding the treatment of primary pulmonary valve disease (stenosis or regurgitation), but instead refer to the 2008 guidelines for the management of adults with congenital heart disease. (38)

In 2008, the AHA/ACC issued guidelines for the management of adults with congenital heart disease. For patients with isolated valvular pulmonary stenosis, the guidelines make recommendations regarding balloon valvulotomy or surgical; however, TPVI is not addressed. (39)

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

33477

HCPCS Codes

None

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

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- 516.

3. U.S. Food and Drug Administration. Summary of Safety and Effectiveness Data: Melody™ Transcatheter Pulmonary Valve. 2015; Available at <http://www.accessdata.fda.gov>. Accessed October 23, 2015.

4. 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):1722-1729.

5. Cheatham JP, Hellenbrand WE, Zahn EM, et al. Clinical and hemodynamic outcomes up to 7 years after transcatheter pulmonary valve replacement in the US melody valve investigational device exemption trial. Circulation. Jun 2 2015; 131(22):1960-1970. PMID 25944758

6. Batra AS, McElhinney DB, Wang W, et al. Cardiopulmonary exercise function among patients undergoing transcatheter pulmonary valve implantation in the US Melody valve investigational trial. Am Heart J. Feb 2012; 163(2):280-287. PMID 22305848

7. Armstrong AK, Balzer DT, Cabalka AK, et al. One-year follow-up of the Melody transcatheter pulmonary valve multicenter post-approval study. JACC Cardiovasc Interv. Nov 2014; 7(11):1254-1262. PMID 25459038

8. Gillespie MJ, McElhinney DB, Kreutzer J, et al. Transcatheter Pulmonary Valve Replacement for Right Ventricular Outflow Tract Conduit Dysfunction After the Ross Procedure. Ann Thorac Surg. Sep 2015; 100(3):996-1003. PMID 26190388

9. 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):1964-1972.

10. 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):1260-1265.

11. Khambadkone S, Coats L, Taylor A, et al. Percutaneous pulmonary valve implantation in humans: results in 59 consecutive patients. Circulation. 2005; 112(8):1189-1197.

12. Momenah TS, El Oakley R, Al Najashi K, et al. Extended application of percutaneous pulmonary valve implantation. J Am Coll Cardiol. 2009; 53(20):1859-1863.

13. Nordmeyer J, Coats L, Bonhoeffer P. Current experience with percutaneous pulmonary valve implantation. Semin Thorac Cardiovasc Surg. 2006; 18(2):122-125.

14. 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):810-815.

15. 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):439-448.

16. Muller J, Engelhardt A, Fratz S, et al. Improved exercise performance and quality of life after percutaneous pulmonary valve implantation. Int J Cardiol. May 15 2014; 173(3):388-392. PMID 24713459

17. Butera G, Milanesi O, Spadoni I, et al. Melody transcatheter pulmonary valve implantation. results from the registry of the Italian Society of Pediatric Cardiology (SICP). Catheter Cardiovasc Interv. Jun 21 2012. PMID 22718682

18. Fraisse A, Aldebert P, Malekzadeh-Milani S, et al. Melody (R) transcatheter pulmonary valve implantation: results from a French registry. Arch Cardiovasc Dis. Nov 2014; 107(11):607-614. PMID 25453718

19. Borik S, Crean A, Horlick E, et al. Percutaneous pulmonary valve implantation: 5 years of follow-up: does age influence outcomes? Circ Cardiovasc Interv. Feb 2015; 8(2):e001745. PMID 25652317

20. Cheatham SL, Holzer RJ, Chisolm JL, et al. The medtronic melody(R) transcatheter pulmonary valve implanted at 24-mm diameter-it works. Catheter Cardiovasc Interv. Jan 29 2013. PMID 23359563

21. Boshoff DE, Cools BL, Heying R, et al. Off-label use of percutaneous pulmonary valved stents in the right ventricular outflow tract: time to rewrite the label? Catheter Cardiovasc Interv. May 2013; 81(6):987-995. PMID 22887796

22. Meadows JJ, Moore PM, Berman DP, et al. Use and performance of the Melody Transcatheter Pulmonary Valve in native and postsurgical, nonconduit right ventricular outflow tracts. Circ Cardiovasc Interv. Jun 2014; 7(3):374- 380. PMID 24867892

23. Malekzadeh-Milani S, Ladouceur M, Cohen S, et al. Results of transcatheter pulmonary valvulation in native or patched right ventricular outflow tracts. Arch Cardiovasc Dis. Sep 10 2014. PMID 25218009

24. Demkow M, Ruzyllo W, Biernacka EK, et al. Percutaneous edwards SAPIEN() valve implantation for significant pulmonary regurgitation after previous surgical repair with a right ventricular outflow patch. Catheter Cardiovasc Interv. Feb 15 2014; 83(3):474-481. PMID 23804542

25. Odemis E, Guzeltas A, Saygi M, et al. Percutaneous pulmonary valve implantation using Edwards SAPIEN transcatheter heart valve in different types of conduits: initial results of a single center experience. Congenit Heart Dis. Sep-Oct 2013; 8(5):411-417. PMID 23448542

26. Faza N, Kenny D, Kavinsky C, et al. Single center comparative outcomes of the edwards sapien and medtronic melody transcatheter heart valves in the pulmonary position. Catheter Cardiovasc Interv. Sep 25 2012. PMID 23008193

27. Haas NA, Moysich A, Neudorf U, et al. Percutaneous implantation of the Edwards SAPIEN pulmonic valve: initial results in the first 22 patients. Clin Res Cardiol. Feb 2013; 102(2):119-128. PMID 22932954

28. Kenny D, Hijazi ZM, Kar S, et al. Percutaneous implantation of the Edwards SAPIEN transcatheter heart valve for conduit failure in the pulmonary position: early phase 1 results from an international multicenter clinical trial. J Am Coll Cardiol. Nov 15 2011; 58(21):2248-2256. PMID 22078433

29. FDA summary of Safety and Probable Benefit. Melody® Transcatheter Pulmonary Valve and Ensemble® Transcatheter Valve Delivery System. Available at <http://www.accessdata.fda.gov>. Accessed June, 2011.

30. McElhinney DB, Cheatham JP, Jones TK, et al. Stent fracture, valve dysfunction, and right ventricular outflow tract reintervention after transcatheter pulmonary valve implantation: patient-related and procedural risk factors in the US Melody Valve Trial. Circ Cardiovasc Interv. Dec 1 2011; 4(6):602-614. PMID 22075927

31. McElhinney DB, Benson LN, Eicken A, et al. Infective endocarditis after transcatheter pulmonary valve replacement using the Melody valve: combined results of 3 prospective North American and European studies. Circ Cardiovasc Interv. Jun 1 2013; 6(3):292-300. PMID 23735475

32. Malekzadeh-Milani S, Ladouceur M, Iserin L, et al. Incidence and outcomes of right-sided endocarditis in patients with congenital heart disease after surgical or transcatheter pulmonary valve implantation. J Thorac Cardiovasc Surg. Aug 9 2014. PMID 25218536

33. Boudjemline Y, Malekzadeh-Milani S, Patel M, et al. Predictors and outcomes of right ventricular outflow tract conduit rupture during percutaneous pulmonary valve implantation: a multicentre study. EuroIntervention. Sep 22 2014. PMID 25244126

34. Morray BH, McElhinney DB, Cheatham JP, et al. Risk of coronary artery compression among patients referred for transcatheter pulmonary valve implantation: a multicenter experience. Circ Cardiovasc Interv. Oct 1 2013; 6(5):535-542. PMID 24065444

35. Fraisse A, Assaidi A, Mauri L, et al. Coronary artery compression during intention to treat right ventricle outflow with percutaneous pulmonary valve implantation: incidence, diagnosis, and outcome. Catheter Cardiovasc Interv. Jun 1 2014; 83(7):E260-268. PMID 24619978

36. Van Dijck I, Budts W, Cools B, et al. Infective endocarditis of a transcatheter pulmonary valve in comparison with surgical implants. Heart. May 15 2015; 101(10):788-793. PMID 25539944

37. Malekzadeh-Milani S, Ladouceur M, Patel M, et al. Incidence and predictors of Melody(R) valve endocarditis: a prospective study. Arch Cardiovasc Dis. Feb 2015; 108(2):97-106. PMID 25445752

38. Nishimura RA, Otto CM, Bonow RO, et al. 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart DiseaseA Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014; 63(22):e57-e185.

39. Warnes CA, Williams RG, Bashore TM, et al. ACC/AHA 2008 Guidelines for the Management of Adults With Congenital Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Develop Guidelines on the Management of Adults With Congenital Heart Disease) Developed in Collaboration With the American Society of Echocardiography, Heart Rhythm Society, International Society for Adult Congenital Heart Disease, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2008; 52(23):e143-e263.

40. Transcatheter Pulmonary Valve Implantation. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2015 November) Surgery 7.01.131.

Policy History:

Date Reason
10/15/2017 Reviewed. No changes.
4/15/2016 Document updated with literature review. Coverage unchanged.
4/15/2015 Reviewed. No changes.
8/15/2014 Document updated with literature review. Coverage unchanged.
10/15/2012 New medical document. (Transcatheter pulmonary valve implantation was previously considered experimental, investigational and unproven on SUR707.028 Transcatheter Heart Valve Replacement). The following change was made: Transcatheter pulmonary valve implantation may be 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 when a listed condition is met. Transcatheter pulmonary valve implantation is considered experimental, investigational and unproven for all other indications. [NOTE: A link to the medical policy titled “Transcatheter Heart Valve Replacement” can be found at the end of medical policy titled SUR707.028 Transcatheter Aortic-Valve Implantation for Aortic Stenosis]

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