| Coverage Policy Manual | |
| Policy #: | 2012002 |
| Category: | Surgery |
| Initiated: | January 2012 |
| Last Review: | June 2023 |
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| Transcatheter Pulmonary Valve Implantation | |
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| 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 who has previously undergone RVOT surgery are additional indications. Patients with prior congenital heart disease CHD repair are at risk of needing repeated reconstruction procedures.
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. Individuals living with congenital heart disease also face disparities in social determinants of health and the inability to obtain quality lifelong care for their condition which can contribute to inequities in morbidity and mortality (Lopez, 2022).
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 (Khambadkone, 2007).
Treatment options for pulmonary stenosis include open surgery with valve replacement, balloon dilatation, or percutaneous stenting (Khambadkone, 2007). The established 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 (McElhinney, 2010).
Regulatory Status
Devices for transcatheter pulmonary valve implantation were initially cleared from marketing by the U.S. Food and Drug Administration (FDA) through the humanitarian device exemption (HDE) process or used off-label until approved by FDA through the premarket approval (PMA):
In January 2010, the Melody® TPV and the Ensemble® Transcatheter Valve Delivery System (Medtronic) were approved by the FDA under the Humanitarian Device Exemption (HDE) Program for use as an adjunct to surgery in the management of pediatric and adult patients with the following clinical conditions:
On January 27, 2015, approval of the Melody® system was amended to a PMA because FDA determined that the device represented a breakthrough technology. The PMA was based, in part, on 2 prospective clinical studies, the Melody TPV Long-term Follow-up Post Approval Study and the Melody TPV New Enrollment Post Approval Study.
On February 24, 2017, approval of the Melody® system was expanded to include patients with a dysfunctional surgical bioprosthetic valve (valve-in-valve).
The Edwards SAPIEN XT™ Transcatheter Heart Valve (Pulmonic) (Edwards Lifesciences) was approved by FDA in 2016 "for use in pediatric and adult patients with a dysfunctional, noncompliant Right Ventricular Outflow Tract (RVOT) conduit with a clinical indication for intervention and:
The approval for the pulmonic valve indication is a supplement to the 2014 PMA for use of the Edwards SAPIEN XT™ Transcatheter Heart Valve System for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis and who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (ie, Society of Thoracic Surgeons operative risk score ≥8% or at a ≥15% risk of mortality at 30 days).
The Harmony™ Transcatheter Pulmonary Valve (Medtronic) received breakthrough technology status in 2019 and PMA in 2021. This device is indicated "for use in pediatric and adult patients with severe pulmonary regurgitation (determined by echocardiography and/or pulmonary regurgitant fraction ≥ 30% by cardiac magnetic resonance imaging) who have a native or surgically-repaired right ventricular outflow tract and are clinically indicated for surgical pulmonary valve replacement."
FDA product code: NPV
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Policy/ Coverage: |
Effective June 2021
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Transcatheter pulmonary valve implantation with a Food and Drug Administration-approved valve meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for patients with congenital heart disease and current right ventricular outflow tract obstruction (RVOT) or regurgitation including the following indications:
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Transcatheter pulmonary valve implantation for all other indications does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For contracts without primary coverage criteria, transcatheter pulmonary valve implantation is considered investigational for all other indications. Investigational services are considered specific contract exclusions in most member benefit certificates of coverage.
Effective Prior to June 2021
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Transcatheter pulmonary valve implantation meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for patients with congenital heart disease and current right ventricular outflow tract obstruction (RVOT) or regurgitation including the following indications:
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Transcatheter pulmonary valve implantation for all other indications does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For contracts without primary coverage criteria, transcatheter pulmonary valve implantation is considered investigational for all other indications. Investigational services are considered specific contract exclusions in most member benefit certificates of coverage.
Effective Prior to June 2018
Transcatheter pulmonary valve implantation when performed according to FDA approved indications meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes 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 for all other indications does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For contracts without primary coverage criteria, transcatheter pulmonary valve implantation is considered investigational for all other indications. Investigational services are considered specific contract exclusions in most member benefit certificates of coverage.
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| Rationale: |
The published literature on 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 (McElhinney, 2010) (Zahn, 2009). This study was designed to follow 150 patients over a five-year period. Eligibility criteria included a dysfunctional right ventricular outflow tract 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 >40mm Hg or severe pulmonary regurgitation was required, and for patients with NYHA class II-IV heart failure, a mean gradient of >35mm 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 six months.
Interim results from this trial have been published (McElhinney, 2010) (Zahn, 2009). The most recent publication (McElhinney, 2010) reported on 136 patients who underwent attempted transcatheter pulmonary valve implantation. 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 >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 six 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. 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%).
There were 64 patients in the FDA analysis that reached six months of follow-up. Of these, 56/64 (87.5%) had acceptable hemodynamic function of the valve by doppler echocardiography. At six 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. (Lurz, 2008) reported on 163 patients who underwent attempted transcatheter pulmonary valve implantation from four clinical centers in Europe. Eligibility for the procedure included elevated RV systolic pressure, increased RVOT dimensions, and either symptoms or evidence of severe right ventricular dysfunction. Procedural success was achieved in 155/163 patients (95.1%). Procedural complications occurred in 12/163 (7.4%), eight of which were considered serious and five 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 twelve months follow-up, >90% of patients had absent or mild valve dysfunction as measured by echocardiography.
Eicken et al. (Eicken, 2011) reported on 102 consecutive patients (mean age 21.5 years) undergoing transcatheter pulmonary valve implantation at two centers in Germany. Eligibility for the procedure included RVOT dysfunction with evidence of right ventricular compromise or increased right ventricular 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 36mm Hg to 15mm 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 (Vezmar, 2010) (Nordmeyer, 2006) (Khambadkone, 2005) (Nordmeyer, 2008). 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 two 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 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.
In patients who are not candidates for open surgery, or who are high-risk for surgery due to other medical commorbidities, alternative treatment options are limited. Expert opinion indicated near uniform support for use of TPVI in patients who not candidates for open repair, or were high risk for open surgery. Based on the expert opinion and the evidence on short-term success, TPVI is considered to meet primary coverage criteria for patients who are not candidates for open repair, or who are high-risk for open repair.
2013 Update
A literature search was conducted through January 2013. There was no new literature identified that would prompt a change in the coverage statement. The following is a summary of the key literature identified.
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.
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 (Boshoff, 2012). 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.
Case series reporting on the use of the Edwards SAPIEN® Pulmonic Valve for RVOT obstruction have been published. Kenny et al. reported on a Phase I multicenter study of the Sapien pulmonic valve in 36 patients from 4 clinical centers (Kenny, 2011). 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 to 14% at baseline. Freedom from re-intervention at 6 months was 97%.
Faza et al. reported on 20 patients who underwent successful implantation of the Edwards SAPIEN® pulmonic valve at one clinical center (Faza, 2012). There were no periprocedural deaths, and all but one 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 versus 11.2 mm Hg, p=0.016), but this difference was no longer present when patients were matched for length of follow-up.
Studies Using the Melody™ Valve
A secondary publication from the US Melody TPV trial focused on the change in exercise function following TPVI (Batra, 2012). Patients completed a standardized cardiopulmonary regimen 2 months prior to TPVI and 6 months following TPVI. Results of pre- and post- exercise parameters were available for 94-114 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).
Another publication focusing on adverse events in the US Melody TPV trial was published in 2011 (McElhinney, 2011). This publication reported on adverse events 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 re-interventions for all patients was estimated to be 86% at 27 months, and freedom from re-interventions for patients with stent fracture was estimated at 49% at 2 years.
2014 Update
This policy is being updated with a literature review through January 2014. There were no randomized controlled trials identified assessing the use of transcatheter pulmonary valve implantation. A few case series (Cheatham, 2013; McElhinney, 2013) were identified but do not prompt a change in the coverage statement.
2015 Update
A literature search conducted through January 2015 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
Non-FDA-Approved Indications
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 making up at least part of the circumference (Meadows, 2014). 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 (Malekzadeh-Milani, 2014). 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 largediameter conduits, respectively (Demkow, 2014; Odemis, 2013). The authors report high rates of successful valve implantation, but long term follow up is not reported.
Non-FDA-Approved Devices
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 (Malekzadeh-Milani. 2014). 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 over the age of 5 with RVOT obstruction, pulmonary regurgitation, or mixed lesions, who underwent transcatheter therapies, including balloon dilatation, bare metal stent placement, or TPV placement (Boudjemline, 2014). 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 to 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 (Morray, 2013). 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 transcathether RVOT interventions for RVOT obstruction, pulmonary regurgitation, or mixed lesions.29 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.
Ongoing and Unpublished Clinical Trials
A search of the online database ClinicalTrials.gov in September 2014 identified the following interventional trials of TPVI that are currently ongoing:
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. For these off-label uses, TPVI is considered investigational.
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 (Nishimura, 2014).
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, transcathether pulmonary valve implantation is not addressed (Warnes, 2008).
2016 Update
A literature search conducted through November 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
Non-FDA-Approved Indications
Analysis of data from the Valve-in-Valve International Database (VIVID) multicenter registry evaluated the off-label use of transcatheter aortic and TPVI prostheses for tricuspid valve-in-valve implantation (TVIV) (McElhinney, 2016). There were 150 out of 156 patients in the registry in whom TVIV was successful with a Melody (n=93) or Sapien (n=57) valve. During a median of 13.3 months of follow-up, 22 (15%) patients died, all with NYHA class III or IV. There were 10 tricuspid valve re-interventions (6.6%) and 3 additional patients (2%) who had significant recurrent dysfunction of the valve. Before intervention 71% of patients were NYHA class III or IV, while at follow-up 77% of surviving patients were NYHA class I or II (p<0.001).
Practice Guidelines and Position Statements
In 2015, the Society for Cardiovascular Angiography and Interventions (SCAI), American Association for Thoracic Surgery (AATS), American College of Cardiology (ACC) and the Society of Thoracic Surgeons (STS) published a consensus-based report on operator and institutional requirements for TPVI (Hijazi, 2015). Recommendations to qualify for a TPVI program included 150 catheterizations/year, association with a surgical program, submission of all cases to a national registry, and for patients, 80% freedom from re-intervention at 1-year.
2017 Update
A literature search conducted using the MEDLINE database through November 2017 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
2018 Update
Annual policy review completed with a literature search using the MEDLINE database through May 2018. The key identified literature is summarized below.
TPVCI Devices And Uses Approved By FDA
The Melody TPV New Enrollment Study was intended to roll in the new patient enrollment study specified as a condition of approval for the Melody TPV HDE on January 25, 2010 (FDA, 2010). This study used the protocol dated September 24, 2013, Version 2, included in H080002/S015. The study is a prospective, nonrandomized, multicenter, historically controlled clinical trial, designed to assess the postmarket performance of the Melody TPV in a representative population of providers and patients, with 5-year follow-up. The primary endpoint is freedom from TPV dysfunction, with a performance goal of 75% or greater at 6 months. Secondary end points include procedural success, serious procedural- and device-related adverse events, stent fracture, reintervention on the TPV, surgical replacement of the RVOT conduit, death (all-cause, procedure-related, and device-related), and NYHA classification.
The February 2017 approval of the Melody system expanded to include patients with a dysfunctional surgical bioprosthetic valve (valve-in-valve) is based on data pooled from 3 sources\l " (FDA, 2017):
Of 125 patients pooled from the 3 studies listed above, 56.8% (71) patients were available for analysis at study completion, the 1-year postimplant visit. Baseline pooled subject median age was 22.0 years (range, 5.0-79 years), with 45.6% female and 54.4% male. Tetralogy of Fallot was the most common congenital heart disease diagnosis recorded in 72.8% of subjects, 66.4% of whom had pulmonary stenosis or atresia. There was no mortality for any cause, major stent fracture, occurrence of endocarditis, RVOT reoperation, or catheter reintervention among available patients at 1 year. Procedural failure as defined by more than trivial pulmonary regurgitation by angiography postimplant occurred in 10.1% (12/119) subjects. There were no device explants within 24 hours of implantation. The mean RVOT gradient was reduced from 29.5 mm Hg at baseline to 14.3 mm Hg at 1 year postimplantation. In this PMA, existing clinical data were not leveraged to support approval of a pediatric patient population. This submission included pediatric data to support the pediatric indication and no extrapolation was necessary.
An Australian prospective observational registry (2017) reported information accumulated on 17 patients implanted with Melody device between 2009 and 2016 (Markham, 2017). Mixed valvular dysfunction was present in 7 (41%) patients and 11 (59%) had corrected tetralogy of Fallot. Device implantation was successful in all patients. Peak RVOT gradient was significantly reduced, and there was no significant regurgitation postprocedure. There was 1 (6%) major procedural adverse event and 2 (12%) major adverse events at last recorded follow-up. There were no patient deaths. Follow-up cardiac magnetic resonance imaging revealed a significant reduction in indexed RV end diastolic volume.
A 2017 retrospective review of 25 patients undergoing Melody TPVI and 178 surgical pulmonic valve surgeries (bioprostheses and homografts) was reported from New Zealand from October 2009 to May 2015 (O'Donnell, 2017). Four (16%) implant patients experienced endocarditis. Two patients presented with life-threatening endocarditis and obstructive vegetation at 14 and 26 months postimplant, respectively. Two additional patients presented with subacute endocarditis at 5.5 years postimplant. At a median follow-up of 2.9 years, 4 (2%) patients had developed endocarditis in the surgical group.
2020 Update
A literature search was conducted through May 2020. There was no new information identified that would prompt a change in the coverage statement.
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through May 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Ribeiro et al performed a systematic review and meta-analysis of 18 nonrandomized comparative studies of SPVI and TPVI (Ribeiro, 2020). No RCTs were identified. There were no significant differences in age or gender between the groups, but there were significant differences in anatomic and functional characteristics. Patients undergoing TPVR were more likely to have pulmonary stenosis (29% vs 12%), while those undergoing SPVR were more likely to have pulmonary regurgitation (57% vs 22%). There were large numerical differences in the presence of a native ventricle outflow tract/transannular patch (TPVR: 16%, SPVR: 60%; odds ratio 0.20, 95% CI: 0.03 to 1.31), but this difference did not achieve statistical significance. Meta-analysis suggested a reduction in peri-procedural complications 16.5% vs 41.3%, p=.01) and length of hospital stay (-4.32 days) with the percutaneous approach, with an increased risk of infective endocarditis (5.8% vs 2.7%, p<.001). There were no significant differences in early mortality, late mortality and need for reintervention. Interpretation is limited by the differences in baseline characteristics between the 2 groups and the possibility of selection bias. The authors noted that a number of patients underwent SPVR because they were not candidates for TPVR due to RVOT anatomy and/or other cardiac defects.
Georgiev et al interrogated a database of all patients who had undergone TPVI (n=241) with the Melody valve or SPVR (n=211) between 2006 and 2018 at a European heart center (Georgiev, 2020). If technically possible, TPVI was preferred. Patients with inappropriate anatomy of the coronary arteries or with large RVOTs were treated with SPVI. The median follow-up time was 5.4 years (3 months to 12.5 years). Estimated survival after 10 years was 94% in the Melody group and 92% in the SPVR group. Infective endocarditis tended to be higher with the percutaneous approach, but there was no difference in survival of the implanted pulmonary valve (TPVI: 80% vs SPVR: 73%, p=.46). There were a number of significant differences in patient characteristics and follow-up, limiting interpretation of these results.
A summary of the US FDA SSED for the Harmony TPV (FDA, 2021):
There were 70 patients in the implanted cohort, 20 were from the feasibility phase, 31 were in the pivotal phase with the current TPV 22 and TPV 25 devices, and 19 were in the pivotal cohort with an earlier version (cTPV 25). Technical success was achieved in 95.7% of implantations, and the clinical endpoint of acceptable hemodynamic function without reintervention at 6 months was met in 89.2% of patients. The proportion of patients with severe pulmonary regurgitation decreased from 84.4% at baseline to 1.7% at 6 mo. Four out of 70 patients (5.7%), required explant of the TPV; 2 were in the feasibility phase and 2 were with a prior version of the device. There were no explants with the current devices in the pivotal study and no mortalities up to the 6 month follow-up. Quality of life, measured by the SF-36, was improved most in the areas of physical functioning and role limitations due to physical health. Follow-up to 5 years is continuing.
In 2020, the Society for Cardiovascular Angiography and Interventions and the Adult Congenital Heart Association published a position statement on operator and institutional recommendations for transcatheter pulmonary valve implantation (TPVI) (Aboulhosen, 2020). Included were recommendations for interventional training, practicing physician competency, ongoing education and training, and institutional and team requirements.
In 2018, the American College of Cardiology and American Heart Association and 6 other societies published comprehensive guidelines on the management of patients with congenital heart disease (Stout, 2019). Included are recommendations for treatment of pulmonary stenosis, pulmonary regurgitation and tetralogy of Fallot.
ACC/AHA Guidelines on the Management of Patients with Tetrology of Fallot:
"Pulmonary valve replacement (surgical or percutaneous) for relief of symptoms is recommended for patients with repaired TOF and moderate or greater PR with cardiovascular symptoms not otherwise explained." Strength of Recommendation: Strong Level of Evidence: non-randomized (moderate quality evidence).
"Pulmonary valve replacement (surgical or percutaneous) is reasonable for preservation of ventricular size and function in asymptomatic patients with repaired TOF and ventricular enlargement or dysfunction and moderate or greater PR.” Strength of Recommendation: Moderate. Level of Evidence: non-randomized (moderate quality evidence).
"Surgical pulmonary valve replacement may be reasonable for adults with repaired TOF and moderate or greater PR with other lesions requiring surgical interventions.” Strength of Recommendation: Weak. Level of Evidence: consensus of expert opinion
"Pulmonary valve replacement, in addition to arrhythmia management, may be considered for adults with repaired TOF and moderate or greater PR and ventricular tachyarrhythmia." Strength of Recommendation: Weak. Level of Evidence: consensus of expert opinion
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through May 2022. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Jones et al reported on 10-year outcomes of the Melody IDE trial (Jones, 2022). There were 171 patients enrolled in the Melody IDE trial, and 58 of those patients completed the 10-year follow-up assessment. The primary outcome assessed was freedom from TPV dysfunction; additional outcomes were time-dependent (i.e., time to catheter reintervention, surgical RVOT reoperation, stent fracture, and death). The estimated freedom at 10 years from TPV dysfunction was 53% (95% CI, 40% to 65%) and was significantly shorter in children than in adults. The estimated freedom from mortality at 10years was 90% (95% CI, 79% to 96%) and did not differ significantly between age groups. The estimated freedom from any TPV reintervention and freedom from RVOT reoperation were 60% (95% CI, 47% to 71%) and 79% (95% CI, 67% to87%), respectively.
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through May 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Gillespie et al evaluated results of TPVI after a Ross procedure in a retrospective review of pooled findings from the US Melody TPV trial and PAS and an additional European registry, the manufacturer-sponsored Melody TPV PMSS conducted in Canada and Europe (NCT00688571) (Gillespie, 2015). In the pooled sample (N=358 patients), 67 (19%) had a prior Ross procedure. A Melody valve was successfully implanted in 56 (84%) of 67 Ross patients who underwent catheterization with intent for TPVI. Six (9%) patients 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 discharged from the implant hospitalization with the Melody valve in place.
Five-year outcomes from the early feasibility study (US FDA SSED for the Harmony TPV) were published in 2021 in the form of a research letter, demonstrating sustained valve function and freedom from moderate-to-severe valve or perivalvular leak. (Gillespie, 2021). There were no additional explanations beyond the 2 previously reported and no reports of endocarditis. One sudden cardiac death of unknown relatedness to the device occurred 3.5 years post-implantation.
McElhinney et al published an analysis of data from a multicenter registry of 2476 individuals who underwent TPV replacement with a Melody (82%) or Sapien (18%) valve between July 2005 and March 2020 (McElhinney, 2022). Patients ranged in age from 10 months to 79 years at implant (median 20.5 years). Median duration of follow-up was 2.8 years (Q1 to Q3, 0.8 to 5.4; mean: 3.4 + 2.9 years); 29% were followed for 5 or more years and 10% for 8 or more years. A total of 95 patients died after TPV replacement, most commonly from heart failure (n=24). The cumulative incidence of death was 8.9% (95% CI, 6.9% to 11.5%) 8 years post-procedure. A total of 258 patients underwent TPV reintervention. At 8 years, the cumulative incidence of any TPV reintervention was 25.1% (95% CI, 21.8% to 28.5%) and of surgical TPV reintervention was 14.4% (95% CI, 11.9% to 17.2%). The authors concluded that the results were comparable to outcomes of surgical conduit/valve replacement across a wide range of patient ages. A second analysis from the same registry focused on risk factors for and outcomes of endocarditis (McElhinney, 2021). A total of 82 patients were diagnosed with endocarditis a median of 2.7 years after TPVR, for a cumulative incidence of 9.5% (95% CI:7.9%-11.1%) at 5 years and 16.9% (95% CI: 14.2%-19.8%) at 8 years. Overall, reintervention was less often required to treat endocarditis than for other reasons, but valve explant was more often caused by endocarditis. Endocarditis was severe in 44% of patients, and 12 patients (6.6%) died, nearly all of whom were infected with Staphylococcus aureus. Younger age, a previous history of endocarditis, and a higher residual gradient were risk factors for endocarditis, but transcatheter pulmonary valve type was not.
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