Medical Policy

This document addresses the transcatheter (percutaneous or catheter-based) approach for pulmonary heart valve replacement, transcatheter mitral valve edge-to-edge repair (also referred to as transcatheter mitral valve repair using leaflet repair or percutaneous annuloplasty), transcatheter mitral valve replacement, and transcatheter tricuspid valve repair or replacement.

Note: For additional information on aortic valve procedures please see the following related document:

• CG-SURG-131 Transcatheter Aortic Heart Valve Procedures

Note: For a high-level overview of this document, please see "Summary for Members and Families" below. 

Medically Necessary:

I. Transcatheter Mitral Edge-to-Edge Repair:

Transcatheter mitral edge-to-edge repair/transcatheter mitral valve repair using an FDA approved device* is considered medically necessary when individual has one of the following conditions:

1. Chronic degenerative (primary) mitral regurgitation (MR) and meets all the following criteria;
   1. Graded as moderate-to-severe or severe (3+ to 4+) MR; and
   2. Severely symptomatic heart failure (NYHA class III or IV); and
   3. Echocardiogram demonstrates that the primary regurgitant jet results from malcoaptation of the A2 and P2 scallops of the mitral valve; and
   4. Prohibitive surgical risk for open surgical therapy (predicted risk of surgical mortality greater than or equal to 8% at 30 days) as determined by at least two physicians (Multidisciplinary Heart valve team);
      or
2. Functional (secondary) MR and meets all the following criteria:
   1. Graded as moderate-to-severe or severe (3+ to 4+) MR; and
   2. Severely symptomatic heart failure (NYHA class III or IV); and
   3. Echocardiogram demonstrates that the primary regurgitant jet results from malcoaptation of the A2 and P2 scallops of the mitral valve; and
   4. MR severity persist despite maximally tolerated guideline-directed medical therapy as determined by at least two physicians (Multidisciplinary Heart Team).

*Note: Please refer to background section of document for list of FDA approved transcatheter mitral valve repair devices.

II. Transcatheter Pulmonary Valve (TPV):

TPV implantation with an FDA approved device** is considered medically necessary when the following criteria are met:

1. Dysfunctional right ventricular outflow tract (RVOT) tract (native, patched or implanted conduit) with one of the following clinical indications for intervention:
   1. moderate or greater pulmonic regurgitation; or
   2. pulmonic stenosis with a mean RVOT gradient greater or equal to 35 mm Hg.

**Note: Please refer to background section of document for list of FDA approved TPVs.

Not Medically Necessary:

Transcatheter pulmonic valve replacement is considered not medically necessary when the criteria above are not met.

Transcatheter mitral edge-to-edge repair/transcatheter mitral valve repair is considered not medically necessary for the treatment of primary or secondary (functional) MR when the criteria above are not met.

Investigational and Not Medically Necessary:

Transcatheter mitral edge-to-edge repair/transcatheter mitral valve repair is considered investigational and not medically necessary for all other indications.

Valve-in-valve transcatheter mitral valve replacement is considered investigational and not medically necessary for all indications.

Transcatheter mitral valve repair using percutaneous annuloplasty (for example, CARILLON Mitral Contour System) is considered investigational and not medically necessary for all indications.

Transcatheter mitral valve replacement (for example, Tendyne™ Transcatheter Mitral Valve System) is considered investigational and not medically necessary for all indications.

Transcatheter tricuspid valve repair or replacement is considered investigational and not medically necessary for all indications.

This document describes clinical studies and expert recommendations, and explains when replacing or repairing heart valves using thin tubes through the blood vessels (called a transcatheter method) instead of open heart surgery is appropriate. It covers procedures for the pulmonary valve between the heart and lungs, the mitral valve between the two right side chambers of the heart, and the tricuspid valve between the two left side chambers of the heart. The following summary does not replace the medical necessity criteria or other information in this document. The summary may not contain all of the relevant criteria or information. This summary is not medical advice. Please check with your healthcare provider for any advice about your health.

Key Information

This document reviews several procedures that repair or replace heart valves using a thin tube called a catheter instead of open-heart surgery. The valves addressed by this document include the mitral, tricuspid, and pulmonary valves, which help keep blood moving in the right direction through the heart. Procedures addressed in this document include: transcatheter mitral valve repair (also known as edge-to-edge repair), transcatheter pulmonary valve replacement, transcatheter mitral valve replacement, and transcatheter tricuspid valve repair or replacement. Each option has different risks and benefits. Some options are approved by the U.S. Food and Drug Administration (FDA) and may help people who cannot have surgery. Other options are still being studied, and better research is needed to know if they help people live longer or feel better.

What the Studies Show

Transcatheter mitral valve repair uses a small device to clip the leaking heart valve leaflets together and reduce backwards flow through this valve (this is called mitral regurgitation [MR]). Research shows this may help people who have symptoms despite using the best medical treatment, especially those at high surgical risk. Some studies found fewer hospital visits for heart failure and improved survival for certain people, while others did not show clear benefits. Common findings include improved quality of life and fewer symptoms, but, when compared to open surgery, the transcatheter approach has a higher chance of needing another procedure later.

Transcatheter pulmonary valve replacement has been shown to help selected people with narrowed or leaking valves. These people often have had previous heart surgery and are not good candidates for another open surgical operation. Research shows these procedures can improve valve function and reduce symptoms in the short term.

Transcatheter mitral valve replacement and transcatheter tricuspid valve procedures are newer and still being studied. Early results show improved quality of life, but it is not yet clear whether they help people live longer. These procedures may be helpful in some cases, but further research is needed to better understand long-term risks and benefits.

When is Transcatheter Mitral Valve Repair Clinically Appropriate?

Transcatheter mitral valve repair may be appropriate in these situations:

• A person has primary MR (the valve itself is abnormal) that is moderate-to-severe or severe; and
• Has severe heart failure symptoms (NYHA class III or IV); and
• An echocardiogram shows the leak is from a specific valve area (A2 and P2); and
• Is too high-risk for surgery, as confirmed by two doctors.
  or
• A person has secondary MR (due to heart muscle problems) that is moderate-to-severe or severe; and
• Has severe heart failure symptoms (NYHA class III or IV); and
• An echocardiogram shows the leak is from the A2 and P2 valve area; and
• The leak continues even after the best possible medical treatment, as confirmed by two doctors.

When is Transcatheter Pulmonary Valve Replacement Clinically Appropriate?

Transcatheter pulmonary valve replacement may be appropriate in these situations:

• A person has a problem with the pathway that carries blood from the right side of the heart to the lungs, either from birth or because of a past surgery (this is called a dysfunctional right ventricular outflow tract and can be due to problems present at birth or from previous surgery); and
• Has moderate or worse pulmonic valve regurgitation (backward flow through the valve); or
• Has the narrowing that requires higher than normal pressure to get sufficient blood through the valve (this is called pulmonic valve narrowing with a pressure gradient of 35 mm Hg or higher).

When is this Not Clinically Appropriate?

Transcatheter mitral valve repair or transcatheter pulmonary valve replacement is not appropriate when the criteria above are not met.

Is this Clinically Appropriate?

The following procedures are not appropriate because they have not been proven to improve health:

• Valve-in-valve transcatheter mitral valve replacement
• Transcatheter mitral valve repair using percutaneous annuloplasty (such as the CARILLON system)
• Transcatheter mitral valve replacement (such as the Tendyne system)
• Transcatheter tricuspid valve repair or replacement

Better studies are needed to know if these procedures help people live longer, feel better, or avoid complications. Using treatments that are not proven to work, or that are not needed, can expose a person to risks without giving any benefit.

(Return to Description/Scope)

Summary

This document outlines evidence-based coverage criteria for transcatheter heart valve procedures, including transcatheter mitral valve repair and replacement (TMVR), transcatheter pulmonary valve replacement (TPVR), and transcatheter tricuspid valve interventions. Coverage determinations are based on U.S. Food and Drug Administration (FDA)-approved indications and a critical appraisal of clinical evidence, with emphasis on randomized controlled trials, long-term outcomes, and comparative effectiveness data. The document differentiates medically necessary indications from investigational uses, reflecting the strength and maturity of available evidence for each valve, device, and intervention type.

Discussion

The Centers for Disease Control and Prevention (CDC) estimates that about 2.5% of the U.S. population has valvular heart disease. The prevalence of valvular heart disease increases with age and affects about 13% of people born before 1943, when penicillin became widely available to treat streptococcal infection and thereby prevent development of rheumatic heart disease. There are about 23,000 deaths due to valvular heart disease each year in the U.S.; approximately 61% of these deaths are due to aortic valve disease, 15% from mitral valve disease, and 24% to dysfunction in the pulmonary or tricuspid valves (CDC, 2024).

The 2020 American College of Cardiology (ACC)/American Heart Association (AHA) Guideline for the Management of individuals with valvular heart disease notes that the severity of valvular heart disease is characterized based on symptoms, valve anatomy, the severity of valve dysfunction, and the response of the ventricle and pulmonary circulation.

Prior to the 1980s, the only surgical options for individuals with severe symptomatic valvular heart disease who received inadequate benefits from medical therapy were open heart procedures. Many of the candidates for these procedures had prohibitive surgical risk due to the severity of their disease. Beginning with percutaneous pulmonary valvuloplasty in 1982, a variety of transcatheter valve interventions have been developed for each of the heart valves.

Transcatheter Pulmonary Valve (TPV):

McElhinney and colleagues (2010) reported on 124 individuals with dysfunctional right ventricular outflow tract (RVOT) obstruction who underwent pulmonary valve placement. This feasibility study looked at the procedural success, safety and short-term effectiveness of the Medtronic Melody™ transcatheter pulmonary valve in individuals with dysfunctional RVOT conduits as defined by either moderate (3+) or severe (4+) pulmonary regurgitation or mean RVOT gradient greater than or equal to 35 mm Hg. The authors concluded that the Melody TPV demonstrated a high rate of procedural success and encouraging short-term function of the Melody valve. All reinterventions in the series were for RVOT obstruction, highlighting the importance of appropriate patient selection. These findings provided the first published evidence for the safe and effective use of the Melody valve platform in appropriately selected individuals.

In January 2010, the FDA granted marketing approval for the Melody TPV and Ensemble Delivery System through the Humanitarian Device Exemption (HDE) process. In January 2015, FDA granted full PMA stating that the Melody TPV and Ensemble Delivery System provides a less invasive treatment option without open heart surgery for individuals with RVOT conduit regurgitation or stenosis. The approval applied to use as an adjunct to surgery in the management of pediatric and adults with the following clinical conditions:

• Existence of a full (circumferential) RVOT conduit that was equal to or greater than 16 mm in diameter when originally implanted and
• Dysfunctional RVOT conduits with a clinical indication for intervention, and either:
  • regurgitation: ≥ moderate regurgitation, or
  • stenosis: mean RVOT gradient ≥ 35 mm Hg

Based on inclusion of such individuals in the 2010 pivotal trial by McElhinney, the FDA humanitarian device label states that individuals with severe regurgitation or stenosis related to a bioprosthetic pulmonic valve should be considered to have a dysfunctional RVOT.

Native or Patched RVOT

The initial FDA approvals were for treatment of dysfunctional RVOT conduits. Since then, there has been interest in expanding transcatheter treatment to include native or patched RVOTs. A native RVOT is one that has never been surgically treated. There are currently three FDA approved valves for implantation in a native or patched RVOT: SAPIEN 3 with the Alterra adaptive prestent, Melody TPV (in a bioprosthetic valve), and the Harmony™ TPV System.

The 2020 European Society of Cardiology (ESC) Guidelines support the use of transcatheter pulmonary valve implantation (TPVI) for native valves with the following statements:

TPVI techniques have become an alternative to open heart surgery primarily in patients with RVOT conduit stenosis/regurgitation, but also in selected patients with native RVOT regurgitation/stenosis. TPVI, when technically feasible, provides outcomes comparable to surgical PVRep [pulmonary valve replacement] and is intended to extend the lifetime of a conduit, hence reducing the number of reoperations during a patient’s lifetime.

The 2020 ESC guidelines include the following statements regarding pulmonary valve replacement (PVRep):

PVRep and/or relief of RVOTO (RVOT obstruction) can be performed with low mortality risk in patients without heart failure and/or advanced ventricular dysfunction.

A recent meta-analysis demonstrated that PVRep can improve symptoms and reduce RV volume, but a survival benefit still needs to be shown.

Currently there are no randomized controlled trials that compare TPVI to PVRep. The VenusP-Valve™ for transcatheter pulmonary valve replacement has been granted investigational device exemption (IDE) by the FDA with anticipated approval in 2026. There are ongoing post approval studies to assess long-term clinical performance and durability of the Melody TPV and the SAPIEN XT Transcatheter Heart Valve - Pulmonic after transcatheter implantation in participants with dysfunctional RVOT conduits.

Transcatheter Mitral Edge-to Edge Repair:

An open surgical technique introduced in the early 1990s to treat mitral regurgitation (MR) involves approximating the middle scallops of the mitral leaflets to create a double orifice with improved leaflet coaptation. The MitraClip™ Delivery System (Abbott Vascular Inc., Santa Clara, CA) was developed as a percutaneous method to accomplish a similar repair. Using a trans-septal approach, general anesthesia, fluoroscopy, and echo guidance, the clip device is centered over the mitral orifice, passed into the left ventricle, and then pulled back to grasp the mitral leaflets creating a double orifice. The MitraClip System consists of implant catheters and the MitraClip permanent implant device.

A prospective, multi-center, single-arm feasibility, safety, and efficacy trial of the MitraClip system was reported by Feldman and colleagues in 2009. A total of 107 participants with 3 to 4+ MR meeting ACC/AHA guidelines for intervention were treated with the device. Ten (9%) had a major adverse event, including 1 death assessed to be unrelated to the procedure. Overall, 79 participants (74%) achieved acute success, and 51 (64%) of those achieving acute success were discharged with MR of 1+ or less. Thirty-two (30%) individuals required open mitral valve surgery within 3 years. At 12 months, 50 of 76 (66%) individuals with acute procedural success remained free from death, mitral valve surgery, or MR > 2+ (primary efficacy endpoint). Within this cohort, 23 participants with functional (not degenerative) MR had similar acute results and durability.

Feldman and colleagues (2011) reported on the EVEREST II trial in which 279 operable participants with moderately severe (3+) or severe (4+) MR were enrolled in a 2:1 ratio to undergo either percutaneous mitral valve repair (n=184) or conventional surgery to repair or replace the mitral valve (n=95). The overall rates of achieving a composite efficacy endpoint were 55% in the percutaneous repair group and 73% in the conventional surgery group at 12 months. The rates of the components of the primary end points for the percutaneous repair compared to the conventional surgery group were reported as follows: death rate of 6% for both groups; surgery for mitral-valve dysfunction, 20% compared to 2%; and MR grade (3+) to (4+), 21% compared to 20% at 12 months. The primary safety endpoint was a composite of major adverse events (MAEs) within 30 days. MAEs occurred in 15% of participants in the percutaneous-repair group and 48% of participants in the surgery group at 30 days. At 12 months, both groups had improved left ventricular size, NYHA functional class and quality-of-life measures, as compared with baseline. Although percutaneous repair was less effective at reducing mitral regurgitation than conventional surgery at 12 months, the procedure was associated with a lower adverse event rate.

Mauri and colleagues (2013) reported 4-year results from the EVEREST II trial. At 48 months, the composite end point of freedom from death, surgery for mitral valve dysfunction, and 3+ or 4+ MR was 39.8% in the transcatheter mitral valve repair arm versus 53.4% in the surgical arm (p=0.070). Participants in the transcatheter mitral valve repair group required surgery to treat residual MR more often compared to the conventional mitral valve surgery group with a rate of 20.4% compared to 2.2% (p<0.0001) at 1 year and 24.8% compared to 5.5% (p<0.001) at 4 years. The authors concluded:

At 4 years, surgery remains the standard of care for treatment of MR among eligible patients. Percutaneous repair is associated with similar mortality and symptomatic improvement but a higher rate of MR requiring repeat procedures, and less improvement in left ventricular dimensions than surgery. Although percutaneous repair of the mitral valve to treat MR was associated with a higher rate of residual MR at 1 year, there was no difference in later occurrence of MR or mitral valve intervention between 1-year and 4-year follow-up.

The MitraClip System obtained European CE Mark approval in March 2008. Maisano and colleagues (2013) reported results from the ACCESS-EU registry study. ACCESS-EU was a prospective, nonrandomized, post-approval study conducted at 14 sites in Europe. The study enrolled a total of 567 participants with significant MR (77.1% functional; 22.9% degenerative) treated with MitraClip therapy. A total of 85% of participants were in NYHA functional class III or IV, and 53% had an ejection fraction (EF) ≤ 40%. Participants in this registry were older and at higher surgical risk than those studied in the EVEREST II comparison trial. There were 19 deaths within 30 days after the procedure in participants who underwent MitraClip implantation. The Kaplan-Meier freedom from mortality at 1 year was 81.8%. Among participants undergoing the MitraClip implantation, a total of 98 (17.3%) deaths were reported within 12 months. There were no device embolizations. Thirty-six participants (6.3%) required MV surgery within 12 months of the procedure. The severity of MR improved at 12 months compared to baseline (p<0.001), with 78.9% of participants with MR 2+ or less. At 12 months, 71.4% of participants were in NYHA Class I or II.

Whitlow and colleagues (2012) reported acute and 12-month results from a study of a cohort at high operative risk for open mitral valve surgery (EVEREST II High Risk Study [HRS]). All participants had congestive heart failure (CHF) (89% NYHA Class III or IV), and the majority had a history of coronary artery disease. More than half of the participants had had prior cardiac surgery. Individuals were required to have symptomatic MR (3+ to 4+) and an estimated surgical mortality rate of greater than or equal to 12% according to the STS operative risk calculator. The study enrolled 78 participants (46 functional MR; 32 degenerative MR) for percutaneous mitral valve repair with the MitraClip device. The participants’ mean age was 77 years. Outcomes of those treated with MitraClip repair were contrasted with a comparator group of 58 participants screened concurrently. Twenty-two of the screened comparator group participants were not included due to lack of institutional review board approval, lack of informed consent, or inability to contact the participant. Of the remaining 36 participants, 8 met HRS eligibility criteria but were not enrolled in the HRS because enrollment had closed or they elected to not enroll. Seven participants in the comparator group were judged eligible based on echo assessment of MR severity, but anatomic eligibility based on transthoracic echo was not confirmed. The remaining 21 participants in the comparator group met all eligibility criteria for HRS except for 1 or more anatomic criteria related to MitraClip placement. The comparison group either received standard medical management (86%) or open mitral valve surgery (14%). STS predicted surgical mortality in the MitraClip group was 14.2% and 14.9% in the comparator group.

The major effectiveness end points at 12 months for the HRS cohort were survival, survival and MR ≤ 2+, NYHA functional class, LV measurements, SF-36 Health Survey quality of life, and rehospitalizations for CHF. The 30-day procedure-related mortality rate was 7.7% in the HRS and 8.3% in the comparator group (p=NS). The 12-month survival rate was 76% in the HRS and 55% in the concurrent comparator group (p=0.047). At 12 months, 78% of the surviving HRS cohort had MR grade of ≤ 2+ and both LV end-diastolic and end-systolic volume improved along with NYHA functional class (74% NYHA class I/II vs. 89% class III/IV at baseline; p<0.0001). SF-36 quality of life measures at 12 months were improved (32.1 at baseline vs. 36.1 12 months after the procedure; p=0.014) and the annual rate of hospitalization for CHF in surviving HRS cohort participants decreased from baseline for those participants with available matched data.

There are several limitations to the EVEREST II HRS study. The comparator group was recruited retrospectively and was limited in size. A randomized comparison of treatment arms was not performed. Follow-up was limited to 12 months. A portion of the individuals in the comparator group did not meet anatomic criteria for MitraClip placement and, therefore, was not directly comparable. In addition, the functional and echocardiographic data at 12 months may overestimate the benefit of the procedure since measures prior to death of non-surviving participants were not included. The early results 1 year after the EVEREST II HRS study suggests the MitraClip device may reduce MR in a subset of individuals deemed at high-risk for mitral valve surgery and result in improvement in clinical symptoms and left ventricular function.

The FDA granted PMA approval for the MitraClip device in October of 2013. Its labeled indication is for percutaneous reduction of symptomatic mitral regurgitation (MR greater than or equal to 3+) due to a primary abnormality of the mitral valve (degenerative MR) in individuals who have been determined to be at prohibitive risk for mitral valve surgery. The FDA Approval of the MitraClip Clip Delivery System was granted based on unpublished trial results for 127 individuals with symptomatic mitral regurgitation due to degenerative MR included in the EVEREST II HRR and REALISM HR registries. The outcomes of this combined cohort were compared with 65 individuals with degenerative MR in a Duke University Medical Center database (Duke High Risk Cohort) who were managed non-surgically. Kaplan-Meier curves showed mortality in the MitraClip cohort was 6.4% at 30 days and 24.8% at 12 months compared to 10.9% at 30 days and 30.6% at 12 months in the Duke High Risk DMR cohort. The analysis cohort was developed post-hoc which limits the interpretation of the data, and the results were described as “only descriptive”.

Obadia and colleagues (2018) reported results from the MITRA-FR trial (NCT01920698) describing off-label use of the MitraClip for secondary MR. This multicenter, randomized, open-label, controlled phase 3 trial was conducted in France and enrolled participants with severe secondary MR. Severe MR was defined as a regurgitant volume of greater than 30 ml per beat or effective regurgitant orifice area of greater than 20 mm². Participants were randomized in a 1:1 ratio to undergo percutaneous mitral valve repair in addition to receiving medical therapy (intervention group; n=152) or to receive medical therapy alone (control group; n=152). Additional inclusion criteria for the study included participants with EF between 15-40% and chronic heart failure symptoms (NYHA functional class II, III or IV). Individuals who had prior mitral valve surgery were excluded from the study. The primary efficacy outcome was a composite of death from any cause and unplanned hospitalization for HF. At 12 months, the rate of the primary outcome was 54.6% (n=83) in the intervention group and 51.3% (n=78) in the control group (odds ratio [OR], 1.16; 95% confidence interval [CI], 0.73 to 1.84; p=0.53). The rate of death from any cause was 24.3% (n=37) in the intervention group and 22.4% (n=34) in the control group (hazard ratio [HR], 1.11; 95% CI, 0.69 to 1.77). A total of 74 participants in the intervention group (48.7%) and 72 participants in the control group (47.4%) had unplanned hospitalizations for heart failure (HR, 1.13; 95% CI, 0.81 to 1.56). The authors concluded that “the rate of the composite primary outcome of death or unplanned hospitalization for heart failure at 12 months did not differ significantly between the intervention group and the control group.”

Stone and colleagues (2018) reported findings from the COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) (NCT01626079). This was a multicenter randomized, controlled, open-label trial that evaluated the use of the MitraClip device in symptomatic individuals with HF and moderate-to-severe or severe secondary MR who remained symptomatic despite maximal guideline directed medical therapy. Participants were randomly assigned to receive transcatheter mitral valve repair with MitraClip plus medical therapy (device group; n=302) or medical therapy alone (control group; n=312). The primary efficacy outcome was all hospitalizations from HF up to a 24-month follow-up period. The annualized rate of hospitalization was 35.8% per patient-year in the device group compared to 67.9% in the control group (HR, 0.53; 95% CI, 0.40 to 0.71; p<0.001). The authors stated that “The rate of freedom from device-related complications at 12 months was 96.6% (lower 95% confidence limit, 94.8%), a rate that exceeded the objective performance goal of 88.0% for the primary safety endpoint (p<0.001).” In the device group the rate of death from any cause within 24 months was 29.1% as compared with 46.1% in the control group (HR, 0.62; 95% CI, 0.46 to 0.82; p<0.001). There was lower mortality (HR, 0.65, 95% CI, 0.49 to 0.86; p=0.003) after adjusting for differences in medical management for HF between trial groups. In participants with HF and moderate-to-severe or severe MR who continued to have symptoms despite maximum medical therapy, the authors concluded that “transcatheter mitral-valve repair resulted in a lower rate of hospitalization for heart failure and lower all-cause mortality within 24 months of follow-up than medical therapy alone. The rate of freedom from device-related complications exceeded a prespecified safety threshold.”

Five-year follow-up data from the COAPT trial were published in 2023. At that time, the annualized rate of hospitalization for heart failure narrowed slightly but continued to show significant between-group differences: 33.1% per year in the device group and 57.2% per year in the control group (HR, 0.53; 95% CI= 0.41 to 0.68). All-cause mortality remained significantly lower at 57.3% in the device group and 67.2% in the control group (HR, 0.72; 95% CI, 0.58 to 0.89). Death or hospitalization for heart failure within 5 years occurred in 73.6% of the device group and in 91.5% of those in the control group (HR, 0.53; 95% CI, 0.44 to 0.64). During the 5-year study, device-specific safety events occurred in 1.4% of study participants (n=4 out of 293); all 4 events occurred within 30 days of the procedure. The COAPT authors used several methods to control for potential biases due to lack of blinding in this industry-sponsored trial. These included rigorous protocols for guideline-directed care and use of centralized resources to confirm events and echocardiographic findings. The authors also noted that “long-term follow-up, which is to be ongoing through 5 years, is necessary to fully characterize the safety and effectiveness of the device.” (Stone, 2023).

On March 14, 2019 the FDA approved the MitraClip^™ NTR/XTR Clip Delivery System for the treatment of secondary/functional mitral regurgitation in select individuals with heart failure who remain symptomatic despite guideline-directed medical therapy (GDMT). This FDA approval was based on evidence reported in the COAPT trial.

In 2019, Arnold and colleagues reported findings from a prospective sub-study of the COAPT trial to better understand the health status outcomes of individuals with HF and 3-4+ secondary MR treated with transcatheter mitral valve repair (TMVr, also known as transcatheter edge-to-edge repair or TEER) compared to standard care. At baseline, individuals had substantially impaired health status (mean Kansas City Cardiomyopathy Questionnaire (KCCQ) and SF-36 health status survey [KCCQ-0S] 52.4 ± 23.0). The health status was unchanged over time in the standard care group, participants in the TMVr group demonstrated substantial improvement in the KCCQ-OS at 1 month as measured by a mean between-group difference of 15.9 points (95% CI 12.9 to 19.5). Most of this improvement was maintained through 24 months when the mean between-group difference was 12.8 points (95% CI 7.5 to 18.2). The authors concluded that individuals with symptomatic HF and 3-4+ secondary MR who underwent TMVr with the edge-to-edge device experienced substantial health status improvement compared with standard care. “This benefit emerged early, was consistent across key subgroups, and was sustained through 24 months follow-up.”

In December 2020, ACC/AHA guideline for the management of valvular heart disease (Otto, 2020), the authors provide recommendations for transcatheter edge-to-edge repair intervention for chronic primary MR and secondary MR:

Chronic Primary MR

• In severely symptomatic patients (NYHA class III or IV) with primary severe MR and high or prohibitive surgical risk, transcatheter edge-to-edge repair (TEER) is reasonable if mitral value anatomy is favorable for the repair procedure and patient life expectancy is at least 1 year (Category 2a)

Secondary MR

• In patients with chronic severe secondary MR related to LV systolic dysfunction (LVEF <50%) who have persistent symptoms (NYHA class II, III, or IV) while on optimal GDMT for HF (Stage D), TEER is reasonable in patients with appropriate anatomy as defined on TEE and with LVEF between 20% and 50%, LVESD ≤70 mm, and pulmonary artery systolic pressure ≤70 mm Hg (Category 2a)

The committee recommendations for TMVr with the MitraClip are based on results from the EVEREST II, MITRA-FR trial and COAPT trials.

In April 2022, AHA/ACC/Heart Failure Society of America (HFSA) guideline for the management of heart failure: a report of the ACC/American Heart Association Joint Committee on clinical practice guidelines (Heidenreich, 2022), authors included 2a recommendation for management of heart failure and secondary MR for transcatheter mitral edge-to-edge. The procedure:

Has been shown to be beneficial in patients with persistent symptoms despite GDMT, appropriate anatomy on transesophageal echocardiography and with LVEF between 20% and 50%, LVESD ≤ 70 mm, and pulmonary artery systolic pressure ≤ 70 mm Hg.

A cardiologist with expertise in the management of HF is integral to shared decision-making for valve intervention and should guide optimization of GDMT to ensure that medical options for HF and secondary MR have been effectively applied for an appropriate time period and exhausted before considering intervention.

In 2024, Anker and colleagues published results of the international RESHAPE-HF2 RCT which enrolled individuals diagnosed with heart failure and moderate-to-severe or severe functional mitral regurgitation. Study participants were randomized 1:1 in a blinded fashion to either mitral valve transcatheter edge-to-edge repair and guideline-recommended medical therapy (TEER+GDMT)(device group; n=250) or GDMT alone (control group; n=255). Study participants had grade 3-4+ functional MR, LVEF between 20 and 50%, and elevated B-type natriuretic peptide (BNP) levels. Eligibility was confirmed by a multidisciplinary heart team using centrally monitored standards. The study’s primary endpoints were reported via unblinded follow-up and were as follows: (1) the rate of the composite of first or recurrent hospitalization for heart failure or cardiovascular death during 24 months; (2) the rate of first or recurrent hospitalization for heart failure during 24 months; and (3) the change from baseline to 12 months in the score on the KCCQ-OS. Study authors reported the following results:

TEER = transcatheter edge-to-edge repair; GDMT = guideline-directed medical therapy

The rate of meeting the combined death and rehospitalization outcome was not significantly different for individuals who entered the study with a NYSHA score of I or II. Device-specific safety events occurred in 4 TEER+GDMT group participants (1.6%). These included 2 hematomas, 1 pericardial effusion, and 1 right atrial perforation requiring thoracotomy. The study’s original statistical plan called for enrollment of 650 participants who would be followed for 24 months to produce 80% power to detect a difference between the treatment arms for the composite endpoint. Both enrollment and follow-up were hampered by the COVID-19 pandemic resulting in significant attrition at 24 months. While the ethics committees would not permit altering the follow-up schedule the steering committee accepted lower enrollment and the 2 additional primary endpoints. Study limitations include the lack of blinding during follow-up which may have influenced decisions to re-hospitalize and subjective responses in KCCQ-OS scoring. RESHAPE-HF2 demonstrates a potential benefit of TEER in selected individuals with moderate-to-severe or severe functional MR who have persistent symptoms despite GDMT.

In 2024, Baldus and colleagues published results from the German, open-label, randomized MATERHORN study. MATERHORN enrolled individuals diagnosed with secondary MR and symptomatic heart failure (NYHA class II or higher) despite GDMT to undergo either TEER (n=102) or open mitral valve surgery (repair or replacement; n=94). The primary efficacy endpoint was a composite measure of death, hospitalization for heart failure, mitral-valve reintervention, implantation of an assist device, or stroke within 1 year after the procedure. The primary safety endpoint was a composite of major adverse events within 30 days following the interventional procedure. The mean age of the participants was 71, 40% were women, and the mean LVEF was 43% (an LVEF of 20-50% was an inclusion criteria). Participants were required to be at high open surgical risk as determined by a multidisciplinary team and have at least 2 of the following: effective regurgitant orifice area of at least 20 mm², biplane vena contracta width of more than 8 mm, a regurgitant volume of at least 30 ml, a regurgitant fraction of at least 50%, or at least two hospitalizations for acute heart failure during the 12 months prior to enrollment. Within 1 year, at least 1 of the components of the primary efficacy endpoint occurred in 16 (16.7%) of the 96 intervention group participants with available data and in 20 (22.5%) of the 89 open surgery group participants with available data (estimated mean difference, -6%; 95% CI, -17 to 6; p<0.001 for noninferiority). A primary safety endpoint event occurred in 15 (14.9%) of the 101 TEER group participants with available data and in 51 (54.8%) of the 93 open surgery group participants with available data (estimated mean difference, -40 percentage points; 95% CI, -51 to -27; p<0.001). There was no significant difference in mortality. As seen with other major transcatheter studies, significantly more individuals in the open surgery arm declined their assigned procedure. Only 94 of the 102 open surgery group participants underwent an open procedure whereas 102 of the 104 TEER group participants received TEER. The study’s original statistical plan projected 80% power assuming 210 participants with a 5% dropout rate. However, only 172 of the 208 participants (83%) were available for evaluation at the 1-year follow up. The majority of attrition (24 of the 36 participants lost to follow up) occurred in the open surgery arm.

Transcatheter Mitral Valve Replacement

On May 23, 2025, the FDA approved the Tendyne Transcatheter Mitral Valve Replacement System for the treatment of symptomatic severe mitral valve dysfunction, including moderate-to-severe or severe mitral regurgitation (MR ≥ grade 3), severe mitral stenosis (MS), or moderate MR with moderate or greater MS-associated with severe mitral annular calcification (MAC) in individuals deemed unsuitable for mitral valve surgery or TEER by a multidisciplinary heart team.

Abbott’s Tendyne Transcatheter Mitral Valve Replacement System received FDA approval based on evidence from the global feasibility study program. Sorajja and colleagues (2019) reported initial outcomes from the first 100 individuals treated with the Tendyne TMVR system in a global feasibility study. The cohort had a mean age of 74 years with 66% classified as NYHA class III or IV. Device implantation was successful in 96% of cases. At 30 days, all-cause mortality was 6%, with 3% experiencing major adverse events. At 1 year, mortality reached 26%, reflecting the high-risk population. Echocardiographic evaluation demonstrated significant reduction of MR with 93% of survivors having none or trace MR. Functional status improved, with a majority improving at least one NYHA class and experiencing marked quality of life gains as measured by KCCQ scores. Limitations included the single-arm design, relatively small sample size, and lack of a control group. In 2021, Muller and colleagues extended these findings with 2-year follow-up data from the first 100 high surgical risk individuals treated with Tendyne TMVR. The 2-year all-cause mortality was 39%. Heart failure hospitalizations decreased significantly from 1.3 events per patient-year pre-procedure to 0.51 post-procedure (p<0.0001). Echocardiography showed near elimination of MR in survivors, with 93.2% having none or trivial MR at 2 years. Functional improvements and quality of life gains noted at 1 year were sustained through 2 years. Device-related adverse events were infrequent beyond the first year, and no structural valve deterioration was observed. The 2-year follow up was subject to many of the same limitations affecting the 1-year follow up - this was an observational, single-arm study with modest sample size and incomplete echocardiographic data at follow-up. The authors note that “The ongoing SUMMIT study (NCT03433274), randomizing participants to Tendyne TMVR or MitraClip transcatheter edge-to-edge repair (TEER), will help establish the anatomic and clinical characteristics that predict success with these two therapies.”

The SUMMIT MAC Premarket Cohort study (NCT03433274) is an ongoing RCT with an estimated completion date of June 2028 and a planned enrollment of approximately 958 participants. This study aims to compare the safety and clinical benefits of the Tendyne Transcatheter Mitral Valve Replacement System to the MitraClip System in individuals with symptomatic moderate-to-severe or severe mitral regurgitation who meet approved indications for MitraClip. Additionally, the trial will evaluate the safety and effectiveness of the Tendyne system in individuals with severe mitral annular calcification at prohibitive surgical risk. The results of this trial will provide important long-term evidence to clarify the role of transcatheter mitral valve replacement compared to repair techniques.

Other Transcatheter Mitral Valve Procedures

The CARILLON Mitral Contour System is an implantable device with a percutaneous catheter delivery system intended to reduce mitral annulus dilatation upon deployment. It has the potential to significantly reduce functional mitral regurgitation (FMR). CARILLON has been proposed to treat heart failure in a minimally invasive fashion. There is an ongoing clinical trial evaluating the use of the CARILLON system to treat individuals with heart failure caused by FMR. At the time of this policy’s update, the CARILLON system had not been granted final approval by the FDA for this indication.

In September 2020, Edwards Lifesciences, the manufacturer of the SAPIEN 3 THV System and SAPIEN 3 Ultra THV System received FDA approval, for ViV implantation in individuals with symptomatic heart disease due to failure of a surgical bioprosthetic mitral valve (either stenosed, insufficient, or combined) who are judged by a heart team, including a cardiac surgeon, to be at high risk or greater for open surgical therapy. The FDA approval for ViV transcatheter mitral valve replacement was based on extracted data from the multicenter STS/ACC Transcatheter Valve Therapy Registry (TVT registry) Analysis. This registry defined high surgical risk as a predicted risk of surgical mortality ≥ 3% at 30 days based on the STS risk score and other clinical co-morbidities unmeasured by the STS risk calculator. At the time of the FDA’s approval, the registry had enrolled 311 participants (SAPIEN XT group, n=241; SAPIEN 3, n=70). Registry data showed a mortality rate at discharge of 5.1% (n=16) and a mortality rate at 30 days after discharge of 6.8% (n=20). For the 30-day follow-up, 84.1% of the participants (n=244) completed their follow-up visit while 15.9% (n=46) missed their visit. The FDA product label states that the long-term durability of the THV system has not been established (Product Label Information, 2020).

In 2020, Whisenant and colleagues published 1-year outcomes following mitral ViV replacement with the Sapien 3 valve as reported to the TVT registry. The average STS risk score of registry participants who had received mitral ViV surgery was 11%. This indicates severe surgical risk. The primary efficacy endpoint was all-cause mortality at 1-year. The primary safety endpoint was procedural technical success. A total of 1529 participants who underwent mitral ViV replacement were enrolled and 1480 (96.8%) achieved procedural technical success. All-cause mortality was 5.4% at 30 days and 16.7% at 1 year. At baseline, 87.1% of the cohort was classified as NYHA Class III/IV heart failure, whereas at 1 year just 9.7% still met that classification. In this industry-sponsored study, authors conclude that mitral ViV with the Sapien 3 transcatheter heart valve is associated with high technical success, low 30- and 1-year mortality along with improvement in heart failure symptoms. Limitations include the observational design and the absence of a standard definition for left ventricular outflow tract obstruction. The authors note that there may have been underreporting of prosthetic dysfunction.

In 2023, Zhou and colleagues published results from a systematic review and meta-analysis of 9 retrospective cohort studies comprised of 3038 study participants. The analysis compared redo surgical mitral valve replacement (SMVR) with TMVR. In this study, TMVR was associated with better results than SMVR for the following outcomes:

Results were either better for SMVR or showed no significant difference for the following outcomes:

The authors acknowledge that the value of their study was reduced by the facts that all of the included studies were retrospective cohorts and none of the studies reported patient-level data. In addition, none of the studies reported follow-up periods longer than 1 year.

In May of 2024, the Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve received expanded FDA approvals for mitral ViV implantation in individuals with symptomatic heart disease due to a failing surgical bioprosthetic mitral valve (stenosed, insufficient, or combined) who are judged by a heart team, including a cardiac surgeon, to be at intermediate or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 4% at 30 days, based on the STS risk score and other clinical co-morbidities unmeasured by the STS risk calculator). The FDA approval was supported by unpublished analysis of data from 2 sources. The first source was real-world off-label use data recorded in the STS/ACC TVT registry for individuals at intermediate STS open surgical risk who received an Edwards SAPIEN 3 or Edwards SAPIEN 3 Ultra THV over a previously implanted bioprosthetic valve. The second source was unpublished investigational use data reported to FDA as the PARTNER 3 Mitral ViV study (P3 MViV; NCT03193801) that included individuals who had a failing surgically implanted bioprosthetic valve in the mitral position demonstrating moderate or greater stenosis and/or moderate or greater insufficiency.

The FDA’s analysis combined data for 452 TVT registry participants with data for 50 individuals who received implants in the P3 MViV study and evaluated 2 primary endpoints for the combined cohort of 502 individuals. The first endpoint was a composite score of death and stroke at 30 days. The second endpoint was the rate of death at 1 year. These outcomes were compared to predetermined performance benchmarks (10.4% at 30 days and 19.6% at 1 year) based on the STS risk calculator “plus a clinical margin to incorporate data uncertainty”. Baseline characteristics showed the cohort’s mean age to be 72 years. The majority were female (57%) and white (82%). The mean STS risk score was 5.0 ± 2.21.

Of the 502 individuals in the combined cohort, 9 had died and 10 were lost to follow up in the first 30 postoperative days. This left 483 available for evaluation 30-days after their procedure. Of these, 425 (88%) completed a visit within the 30-day allotted timeframe. At 1 year after their procedure, 29 individuals had died and 35 were lost to follow up, leaving 439 participants eligible for reevaluation. Of these 439, 308 (70%) completed their 1-year follow-up visit.

The observed primary outcomes were as follows:

Noting that only 88% of eligible participants completed their 30-day follow up, and that only 70% of the eligible participants completed their 1-year follow up, the FDA performed a sensitivity analysis that determined the missing data was unlikely to have affected the primary outcomes. This analysis showed that, among the 195 individuals with missing data, death would have needed to occur in 26.7% to cause the 1-year mortality for the entire cohort to have exceeded the calculated benchmark threshold. That would have been 3.7 times the risk of death observed in those without missing data, a scenario that the FDA thought was unlikely.

The FDA’s efficacy analysis showed the following:

As a condition for this expanded approval, the FDA has required Edwards Lifesciences to maintain a registry tracking outcomes for intermediate risk individuals who receive a mitral ViV implant over a 3-year period or until 1,000 treated individuals are tracked, whichever is greater. This tracking requirement will remain in effect until specified numbers of individuals from currently underrepresented racial and ethnic groups are enrolled.

Although the data compiled by FDA to support their expanded indication for mitral ViV implantation to include individuals at intermediate open surgical risk are promising, their analysis has several limitations. These include the lack of peer review, combining data from unrelated studies, lack of comparison groups, and significant attrition. These results need to be confirmed in a prospective clinical trial comparing results to currently accepted therapies.

Additional data on ViV replacement of mitral valves that are stenosed, insufficient, or bioprosthetic are currently limited to uncontrolled prospective cohorts, registry studies and systematic reviews/meta-analyses with mixed findings (Guerrero, 2023; Ismayl 2023; Mack, 2021; Takagi, 2018; Yoon, 2019; Zahid, 2022; Zhou, 2023; Zia, 2021; Zogg, 2023).

Transcatheter Tricuspid Valve Repair or Replacement:

Transcatheter tricuspid valve repair or replacement (TTVR) for the treatment of tricuspid dysfunction are in early stages of development. Studies have evaluated the use of three devices, the TriClip™ Delivery System, essentially the same clip delivery used for the mitral valve transcatheter edge-to-edge repair (TEER, for example MitraClip), the Cardioband Valve System delivery via transfemoral approach (TRI-REPAIR Study), and the Evoque TTVR system.

In 2023, Sorajja and colleagues conducted a multi-center, prospective RCT of percutaneous tricuspid TEER (TriClip) for individuals with severe, symptomatic tricuspid valve regurgitation (Trial to Evaluate Cardiovascular Outcomes in Patients Treated with the Tricuspid Valve Repair System Pivotal [TRILUMINATE Pivotal]). The primary end point was a composite score of death from any cause or tricuspid-valve surgery, hospitalization for heart failure, and an improvement in quality of life as measured with the KCCQ. The study defined KCCQ improvement as an increase of at least 15 points in the KCCQ score (range, 0 to 100, with higher scores indicating better quality of life) at the 1-year follow-up. The severity of tricuspid regurgitation and safety were also assessed. A total of 350 participants were enrolled. After randomization, 175 participants received the device and 175 in the control group continued to receive guideline-directed medical therapy for heart failure. Ultimately, 170 were successfully implanted with the device. The primary end point marginally favored the tricuspid TEER group (win ratio, 1.48; 95% CI, 1.06 to 2.13; p=0.02). No difference was detected between groups in the incidence of death or the rate of hospitalization for heart failure. The KCCQ quality-of-life score changed by a mean (± SD) of 12.3 ± 1.8 points in the tricuspid TEER group, as compared with 0.6 ± 1.8 points in the control group (p<0.001). At 30 days, 87.0% of the tricuspid TEER group and 4.8% of those in the control group had tricuspid regurgitation of no greater than moderate severity (p<0.001). While TEER demonstrated an improvement in self-reported quality of life, the difference did not reach the pre-specified 15-point improvement. Furthermore, there was only marginally significant clinically meaningful benefit demonstrated in the study’s primary composite outcome measure. The authors noted that death and hospitalization occurred less frequently than expected for participants in both arms of this RCT. They propose that this may have been a result of their rigorous screening and enrollment of individuals with fewer coexisting conditions compared to previous trials. Further long-term study will be needed to confirm this study’s findings.

In a 2023 analysis of use of the win ratio statistical method in cardiovascular trials, Ajufo (2023) acknowledged that the TRILUMINATE Pivotal trial met its primary end point with a win ratio of 1.48 but point out that this was the result of an improvement in the subjective KCCQ score and that there was no significant improvement in the objective measures of mortality or HF rehospitalization. They also noted that TRILUMINATE Pivotal did not find significant between-group differences in diuretic use or 6-minute walk distance at the 1-year follow-up. The authors suggest “that the large patient-reported outcome measure benefit may have had a strong placebo component.” This reinforces the need for further study to understand the clinical outcomes of treatment with the TriClip device.

In 2024, based on the TRILUMINATE Pivotal trial, the FDA granted Abbott approval for their tricuspid TEER system (TriClip G4 for TTVR). The FDA stated that the TriClip G4 System is indicated for the improvement of health status in individuals diagnosed with symptomatic severe tricuspid regurgitation despite being treated optimally with medical therapy who are at intermediate or greater risk for surgery, and in whom tricuspid valve edge-to-edge repair is appropriate as determined by a heart team.

In the same year (2024), the FDA granted Edwards Lifesciences approval for their Evoque TTVR system for individuals with tricuspid valve regurgitation. The system’s approved indication is for individuals with symptomatic severe tricuspid regurgitation despite optimal medical therapy and for whom tricuspid valve replacement is deemed appropriate by a heart team (FDA, 2024). The approval was based on results of the TRISCEND II pivotal trial described below.

In 2024, Luz and colleagues published results of the bRIGHT trial. bRIGHT is a post approval, prospective, single-arm open-label multicenter post market TriClip registry study conducted at 26 sites across Europe. bRIGHT enrolled 511 individuals with significant comorbidities and an average age of 79 years. At baseline, 88% of the study population had baseline massive or torrential tricuspid regurgitation and 80% were in NYHA functional class III/IV. At 1-year, tricuspid regurgitation was reduced to moderate or less in 81% of participants. The percentage of enrollees in NYHA functional class I or II significantly increased (from 21% to 75%; p<0.0001) as did KCCQ score (19-point improvement, p<0.0001; OR, 0.636; 95% CI, 0.42-0.97; p=0.038). This study did not report or analyze medical therapies provided to the enrollees. Within 1 year after their tricuspid TEER procedure, 8.8% of the registry enrollees had died, 15.3% required hospitalization to treat heart failure, 5.5% had new onset renal failure, 0.8% had a cardiac pacemaker inserted, and 3.5% required a tricuspid valve reintervention. Univariate analysis showed several demographic factors to be associated with mortality. These included the baseline KCCQ score, baseline right ventricular tricuspid annular plane systolic excursion, baseline aspartate transaminase (AST), TR grade at 30 days, sex, baseline serum creatinine, and baseline LVEF. The study authors concluded that “tricuspid TEER using the TriClip system was safe and effective through 1 year for subjects with significant tricuspid regurgitation and advanced disease in a diverse real-world population.” The bRIGHT study plans to continue to report results over 5 years. The design of this study does not allow conclusions to be drawn regarding the relative effectiveness of tricuspid TEER compared to medical treatments. Prospective studies are needed to confirm the associations observed in this report.

In 2024, Hahn and colleagues published results from the TRISCEND II pivotal trial discussed above in the section on the initial FDA approval. TRISCEND II was a multinational, prospective, RCT evaluating TTVR with the Edwards Lifesciences EVOQUE system plus medical therapy versus medical therapy alone in 400 individuals with severe symptomatic tricuspid regurgitation. Participants were randomized 2:1 to TTVR plus medical therapy or medical therapy alone, with crossover permitted at 1 year. The primary endpoint used a hierarchical composite “win ratio” encompassing death, right ventricular assist device implantation or heart transplantation, tricuspid valve reintervention, hospitalization for heart failure, quality of life improvements (KCCQ-OS), NYHA functional class, and 6-minute walk distance. The trial demonstrated a statistically significant win ratio favoring TTVR (2.02; 95% CI, 1.56 to 2.62; p<0.001), driven primarily by symptomatic and quality-of-life improvements. However, individual components of the composite showed no significant differences, and the trial was not powered for these. Baseline imbalances included higher comorbidity rates in the medical therapy group. Attrition was significant in the control arm, with only 78% completing 1-year follow-up. Safety events included higher rates of severe bleeding and new permanent pacemaker implantation in the TTVR group. While results support symptomatic benefit of TTVR, the clinical impact on mortality and hospitalization requires further study.

In 2025, Kar and colleagues reported 2-year outcomes from the TRILUMINATE pivotal RCT evaluating TEER with the TriClip device in symptomatic individuals with severe tricuspid regurgitation. Among 572 randomized individuals, tricuspid TEER reduced the annualized rate of recurrent heart failure hospitalization compared with medical therapy alone (HR, 0.72; 95% CI, 0.53-0.98; p=0.04). Freedom from all-cause mortality, tricuspid valve surgery, and tricuspid valve intervention was higher with TEER, driven largely by crossover of control individuals to device treatment after 1 year. Rates of all-cause mortality (17.9% vs. 17.1%) and tricuspid valve surgery (2.3% vs. 4.3%) did not differ significantly between groups. Moderate or less tricuspid regurgitation was present in 84% of the TEER group at 2 years compared to 46% in the medical therapy alone group. Quality of life improvements measured by the Kansas City Cardiomyopathy Questionnaire were sustained. Safety outcomes were favorable, with low rates of stroke, device complications, and conduction disturbances requiring pacemaker implantation. The broad inclusion criteria limit the ability to precisely predict which individuals are most likely to benefit and underscore the need for further research with stratified analyses or more narrowly defined populations. Limitations included a high crossover rate (n=111) from control to treatment group after 1 year (n=44 remaining in the medical therapy cohort), potentially attenuating differences in heart failure hospitalization and mortality. The relatively low mortality rate in both groups and the heterogeneous population warrant cautious interpretation.

In 2025, Hausleiter and colleagues published a consensus document on TTVR as a JACC State of the Art Review. The authors comprised a multinational body of experts representing centers experienced in the performance of TTVR. Many of the authors have financial ties to industry. The authors aimed to provide a unified framework for terminology, patient selection, procedural best practices, follow-up, and the evidence base for orthotopic TTVR. The review highlights consistent improvements in quality of life, heart failure symptoms, and right ventricular reverse remodeling seen in early studies and registries. Much of the document provides expert recommendations on imaging workup, anticoagulation, and device selection, including a proposed patient selection algorithm and anatomic considerations distinguishing TTVR from TEER. At the same time, the authors emphasize persistent uncertainties, particularly regarding the impact of TTVR on long-term outcomes such as heart failure hospitalization and mortality. The consensus strongly supports the need for ongoing randomized trials to clarify clinical benefit and optimize patient selection.

There are currently no published RCTs evaluating the relative risks and benefits of TTVR or T-TEER compared to open surgical valve repair/replacement, largely due to the suboptimal risk-benefit ratio when performed as an isolated procedure.

Requirement for Multidisciplinary Evaluation:

Many major trials assessing the effects of transcatheter valve replacement required multi-physician confirmation of eligibility for the procedure. An informed decision to pursue an intervention may be optimized when a multidisciplinary team with primary care physicians, cardiologists, interventional cardiologists, cardiac surgeons, individuals, and family members communicate and proceed in a coordinated, interdisciplinary manner. Depending on the individual's unique circumstance, additional multidisciplinary team members may include other subspecialty consultants (e.g., hematology, oncology, pulmonology). Care may be optimized by leveraging the expertise and experience of subspecialists, each of whom can weigh in on the nuances of an individual’s disease state relevant to their presenting illness.

Transcatheter heart valve replacement is a less invasive alternative to conventional open-heart surgery that does not require heart-lung bypass. A catheter inserted using a transfemoral (TF), transapical (TA), or transaortic approach allows the introduction of an expandable prosthetic heart valve which is then delivered to the diseased native valve. The TF vascular access approach has been associated with reduced vascular complications (Carrol, 2020).

Two minimally invasive alternatives to surgical mitral valve repair include transcatheter leaflet repair and percutaneous annuloplasty. The purpose of transcatheter mitral valve leaflet repair is to keep the two valve leaflets more closely fitted together, thereby reducing regurgitation. Percutaneous annuloplasty attempts to reshape the mitral annulus using catheters guided through the vasculature to reach the heart to reduce regurgitation.                                                                     

*The FDA has approved marketing of the following mitral, pulmonary and tricuspid THV devices:

**The FDA has approved the following mitral valve TEER devices used for marketing which include the following:

MitraClip NT Clip Delivery System and MitraClip NTR/XTR (Abbott Vascular, Menlo Park, CA)

• The MitraClip Delivery System is indicated for the percutaneous reduction of significant symptomatic MR ≥ 3+ due to primary abnormality of the mitral apparatus (degenerative MR) in individuals who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the benefit from reduction of the MR.

The MitraClip NTR/XTR System, when used with maximally tolerated GDMT, is indicated for the treatment of symptomatic, moderate-to-severe or severe secondary (or functional) MR (MR ≥ Grade III per American Society of Echocardiography criteria) in individuals with left ventricular ejection fraction ≥ 20% and ≤ 50%. And a left ventricular end systolic dimension (LVESD) ≤ 70 mm whose symptoms and MR severity persist despite maximally tolerated GDMT as determined by a multidisciplinary heart team experienced in the evaluation and treatment of HF and mitral valve disease.

PASCAL Precision Transcatheter Valve Repair System

• The PASCAL Precision Transcatheter Valve Repair System is indicated for the percutaneous reduction of significant symptomatic MR ≥ 3+ due to primary abnormality of the mitral apparatus (degenerative MR) in individuals who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the benefit from reduction of the MR.

***The FDA has approved the following TPV for marketing:

Medtronic Melody TPV (Medtronic, Inc., Minneapolis, MN)

• The Melody Transcatheter Pulmonary Valve (TPV) has an HDE approval from the FDA (2015) and is authorized by Federal law (USA) for use in pediatric and adult candidates with a regurgitant or stenotic RVOT conduit (greater than or equal to 16 mm in diameter when originally implanted). The effectiveness of this device for this use has not been demonstrated. FDA approval has been granted for devices for specific indications, through the HDE process. The HDE approval process is applicable to devices intended to benefit individuals in the treatment or diagnosis of conditions or diseases that affect fewer than 4000 individuals in the U.S. per year. An HDE application does not require submission of the results of scientifically valid clinical investigations demonstrating the effectiveness of the device for its intended use. However, the application must contain sufficient information for the FDA to determine that the device does not pose an unreasonable or significant risk of illness or injury and that the probable health benefit outweighs the risks from its use. In 2017, this approval was expanded to include surgical bioprosthetic pulmonary valves (ViV) that have ≥ moderate regurgitation and/or a mean RVOT gradient ≥ 35 mmHg.

Medtronic Harmony TPV System (Medtronic, Inc., Minneapolis, MN)

• In the beginning of 2021, Medtronic, Inc. received FDA premarket approval the Harmony TPV System for use in the management of pediatric and adult candidates with severe pulmonary regurgitation (that is, severe pulmonary regurgitation as determined by echocardiography and/or pulmonary regurgitation fraction greater than or equal to 30% as determined by cardiac magnetic resonance imaging) who have a native or surgically-repaired right ventricular outflow tract and are clinically indicated for surgical valve replacement.

SAPIEN THV Devices (Edwards Lifesciences, Inc., Irvine, CA Edward Lifesciences)

• In 2016, the SAPIEN XT THV and delivery system (previously approved for TAVR) received expanded approval by the FDA for use in children and adults with a dysfunctional, non-compliant RVOT conduit with a clinical indication for intervention and moderate or greater pulmonary regurgitation and/or mean RVOT gradient greater than or equal to 35 mmHg. The procedure is contraindicated in individuals with an inability to tolerate anticoagulation/antiplatelet regimen and present with active bacterial endocarditis.
• In 2020, the Edwards SAPIEN 3 Valve System was approved for pulmonary valve replacement when a pulmonary valve conduit or artificial pulmonary valve stopped working properly.
• In 2021, the Edwards SAPIEN 3 Valve System approval was expanded for use in combination with the Alterra Adaptive Prestent in children and adults with severe pulmonary regurgitation who have a native or surgically-repaired (patched) RVOT.

Congenital heart disease (CHD): Heart problems present at birth.

Conduit: see Right Ventricular Outflow Tract Conduit below.

Humanitarian Device Exemption (HDE): Similar to a PMA application, but is exempt from the effectiveness requirements of a PMA. An HDE application is not required to contain the results of scientifically valid clinical investigations demonstrating that the device is effective for its intended purpose and does not pose an unreasonable or significant risk of illness or injury. The use of the device is limited to 4000 or less individuals per year.

Mitral regurgitation (also known as mitral insufficiency): A disorder in which the heart valve that separates the upper and lower chambers on the left side of the heart does not close properly, resulting in leakage of blood backward through the mitral valve each time the left ventricle contracts and increased pressure and congestion in the lungs.

Premarket Approval (PMA): The most stringent type of device marketing application required by the FDA. A PMA is an application submitted to the FDA to request clearance to market or to continue marketing of a Class III medical device. Class III medical devices are those devices that present significant risk to the individual and/or require significant scientific review of the safety and effectiveness of the medical device prior to commercial introduction. Frequently the FDA requires follow-up studies for these devices.

Prosthesis-patient mismatch (PPM): Occurs when the effective orifice area of the implanted valve is insufficient relative to the individual’s body size, resulting in elevated transvalvular gradients.

Right Ventricular Outflow Tract Conduit (RVOT conduit): a surgically implanted tube that connects the right ventricle of the heart to the pulmonary artery. It is used to bypass or replace a malformed, blocked, or absent segment of the heart’s natural outflow tract.

Win Ratio: a method of reporting composite endpoints in clinical trials. The win ratio method begins with ranking each component of a composite endpoint according to its clinical importance. For example, mortality would be ranked as more important than rehospitalization which, in turn, may be ranked as more important than changes in serum biomarkers or quality of life measures. In this method, each individual in the active treatment group is matched to all individuals with similar clinical characteristics in the control group. Outcomes are compared for each matched pair beginning with the outcomes ranked most clinically important. The individual within each pair is declared a “winner” or “loser” depending on who had the outcome of interest first. If there is no winner for the outcome ranked most important, the method compares the next most important, and so on. The win ratio is the total number of winners in the treatment group divided by the number of losers. Because the win ratio does not include the results for pairs that have no winner or loser (ties), it can overestimate the treatment effect. Furthermore, differences could be driven by quality of life alone.

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met:

When services are Not Medically Necessary:
For the codes listed above when criteria are not met.

When services are Investigational and Not Medically Necessary:
When the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary, or for the following procedure codes:

Peer Reviewed Publications:

1. Ailawadi G, Lim DS, Mack MJ, et al. One-year outcomes after MitraClip for functional mitral regurgitation. Circulation. 2019; 139:37-47.
2. Anker SD, Friede T, von Bardeleben RS, et al. Percutaneous repair of moderate-to-severe or severe functional mitral regurgitation in patients with symptomatic heart failure: baseline characteristics of patients in the RESHAPE-HF2 trial and comparison to COAPT and MITRA-FR trials. Eur J Heart Fail. 2024a; 26(7):1608-1615.
3. Anker SD, Friede T, von Bardeleben RS, et al. Transcatheter valve repair in heart failure with moderate to severe mitral regurgitation. N Engl J Med. 2024b; 391(19):1799-1809.
4. Arnold SV, Chinnakondepalli KM, Spertus JA, et al. Health status after transcatheter mitral-valve repair in heart failure and secondary mitral regurgitation: COAP Trial. J Am Coll Cardiol. 2019; 73(17):2123-2132.
5. Arnold SV, Goates S, Sorajja P, et al. Health status after transcatheter tricuspid-valve repair in patients with severe tricuspid regurgitation. J Am Coll Cardiol. 2024; 83(1):1-13.
6. Arnold SV, Petrossian G, Reardon MJ, et al. Five-year clinical and quality of life outcomes from the CoreValve US Pivotal Extreme Risk Trial. Circ Cardiovasc Interv. 2021; 14(6):e010258.
7. Baldus S, Doenst T, Pfister R, et al. Transcatheter repair versus mitral-valve surgery for secondary mitral regurgitation. N Engl J Med. 2024; 391(19):1787-1798.
8. Del Val D, Ferreira-Neto AN, Wintzer-Wehekind J, et al. Early experience with transcatheter mitral valve replacement: a systematic review. J Am Heart Assoc. 2019; 8(17):e013332.
9. Donal E, Dreyfus J, Leurent G, et al. Transcatheter edge-to-edge repair for severe isolated tricuspid regurgitation: the Tri.Fr Randomized Clinical Trial. JAMA. 2025; 333(2):124-132.
10. Feldman T, Foster E, Glower DD, et al.; EVEREST II Investigators. Percutaneous repair or surgery for mitral regurgitation. N Engl J Med. 2011; 364(15):1395-1406.
11. Feldman T, Kar S, Rinaldi M, et al.; EVEREST Investigators. Percutaneous mitral repair with MitraClip system: safety and midterm durability in the initial EVEREST (Endovascular Valve Edge-to-Edge Repair Study) cohort. J Am Coll Cardiol. 2009; 54(8):686-694.
12. Feldman T, Saibal K, Elmariah S, et al. Randomized comparison of percutaneous repair of surgery for mitral regurgitation. 5-year results of EVERST II. JACC. 2015; 66(25):2844-2854.
13. Feldman T, Wasserman HS, Herrmann HC, et al. Percutaneous mitral valve repair using the edge-to-edge technique: six-month results of the EVEREST Phase I Clinical Trial. J Am Coll Cardiol. 2005; 46(11):2134-2140.
14. Giustino G, Camaj A, Kapadia SR, et al. Hospitalizations and mortality in patients with secondary mitral regurgitation and heart failure: the COAPT Trial. J Am Coll Cardiol. 2022; 80(20):1857-1868.
15. Glower DD, Saibal K, Trento A, et al. Percutaneous mitral valve repair for mitral regurgitation in high-risk patients. Results of the EVEREST II study. JACC. 2014; 64(2):172-181.
16. Guerrero ME, Eleid MF, Wang DD, et al. 5-Year prospective evaluation of mitral valve-in-valve, valve-in-ring, and valve-in-MAC outcomes: MITRAL Trial Final Results. JACC Cardiovasc Interv. 2023; 16(18):2211-2227.
17. Haas NA, Carere RG, Kretschmar O, et al. Early outcomes of percutaneous pulmonary valve implantation using the Edwards SAPIEN XT transcatheter heart valve system. Int J Cardiol. 2018; 250:86-91.
18. Hahn RT, Makkar R, Thourani VH, et al. Transcatheter Valve Replacement in Severe Tricuspid Regurgitation. N Engl J Med. 2024; 392(2):115-126.
19. Imamura T, Nakai M, Iwanaga Y, et al. Two-Year Clinical outcome of MitraClip transcatheter edge-to-edge repair from the J-MITRA registry data. Circ J. 2024; 88(4):539-548.
20. Ismayl M, Abbasi MA, Mostafa MR, et al. Meta-analysis comparing valve-in-valve transcatheter mitral valve replacement versus redo surgical mitral valve replacement in degenerated bioprosthetic mitral valve. Am J Cardiol. 2023; 189:98-107.
21. Jin Q, Long Y, Zhang G, Pan X, et al. Five-year follow-up after percutaneous pulmonary valve implantation using the Venus P-valve system for patients with pulmonary regurgitation and an enlarged native right ventricular outflow tract. Catheter Cardiovasc Interv. 2024; 103(2):359-366.
22. Jones TK, McElhinney DB, Vincent JA, et al. Long-term outcomes after melody transcatheter pulmonary valve replacement in the US Investigational Device Exemption Trial. Circ Cardiovasc Interv. 2022; 15(1):e010852.
23. Kar S, Feldman T, Qasim A, et al. Five-year outcomes of transcatheter reduction of significant mitral regurgitation in high-surgical-risk patients. Heart. 2019; 105(21):1622-1628.
24. Kar S, Makkar RR, Whisenant BK, et al. Two-year outcomes of transcatheter edge-to-edge repair for severe tricuspid regurgitation: the TRILUMINATE pivotal randomized controlled trial. Circulation. 2025; 151(23):1630-1638.
25. Kodali S, Hahn RT, Makkar R, et al. Transfemoral tricuspid valve replacement and one-year outcomes: the TRISCEND study. Eur Heart J. 2023; 44(46):4862-4873.
26. Krittanawong C, Hahn J, Virk HUH, et al. In-hospital complications after MitraClip in patients with heart failure and preserved versus reduced ejection fraction in the United States. Cardiovasc Revasc Med. 2024; 62:34-39.
27. Lim DS, Kim D, Aboulhosn J, et al. Congenital pulmonic valve dysfunction treated with SAPIEN 3 transcatheter heart valve (from the COMPASSION S3 Trial). Am J Cardiol. 2023; 190:102-109.
28. Lurz P, Rommel KP, Schmitz T, et al. Real-world 1-year results of tricuspid edge-to-edge repair from the bRIGHT study. J Am Coll Cardiol. 2024; 84(7):607-616.
29. Machaalany J, Bilodeau L, Hoffmann R, et al. Treatment of functional mitral valve regurgitation with the permanent percutaneous transvenous mitral annuloplasty system: results of the multicenter international Percutaneous Transvenous Mitral Annuloplasty System to Reduce Mitral Valve Regurgitation in Patients with Heart Failure trial. Am Heart J. 2013; 165(5):761-769.
30. Mack M, Carroll JD, Thourani V, et al. Transcatheter mitral valve therapy in the United States: a report from the STS-ACC TVT registry. J Am Coll Cardiol. 2021; 78(23):2326-2353.
31. Maisano F, Franzen O, Baldus S, et al. Percutaneous mitral valve interventions in the real world: early and 1-year results from the ACCESS-EU, a prospective, multicenter, nonrandomized post-approval study of the MitraClip therapy in Europe. J Am Coll Cardiol. 2013; 62(12):1052-1061.
32. Makkar RR, Chikwe J, Chakravarty T, et al. Transcatheter mitral valve repair for degenerative mitral regurgitation. JAMA. 2023; 329(20):1778-1788.
33. Mauri L, Foster E, Glower DD, et al.; EVEREST II Investigators. 4-year results of a randomized controlled trial of percutaneous repair versus surgery for mitral regurgitation. J Am Coll Cardiol. 2013; 62(4):317-328.
34. Mauri L, Garq P, Massaro JM, et al. The EVEREST II Trial: design and rationale for a randomized study of the evalve mitraclip system compared with mitral valve surgery for mitral regurgitation. Am Heart J. 2010; 160(1):23-29.
35. 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. 2011; 4(6):602-614.
36. 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.
37. 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. 2014; 7(3):374-380.
38. Millan X, Skaf S, Joseph L, et al. Transcatheter reduction of paravalvular leaks: a systematic review and meta-analysis. Can J Cardiol. 2015; 31(3):260-269.
39. Muller DWM, Sorajja P, Duncan A, et al. 2-year outcomes of transcatheter mitral valve replacement in patients with severe symptomatic mitral regurgitation. J Am Coll Cardiol. 2021; 78(19):1847-1859.
40. Obadia JF, Messika-Zeitoun D, Leurent G, et al. Percutaneous repair or medical treatment for secondary mitral regurgitation. N Eng J Med. 2018; 379(24):2297-2306.
41. Ponikowski P, Friede T, von Bardeleben RS, et al. Hospitalization of symptomatic patients with heart failure and moderate to severe functional mitral regurgitation treated with MitraClip: insights from RESHAPE-HF2. J Am Coll Cardiol. 2024; 84(24):2347-2363.
42. Ribeiro JM, Teixeira R, Lopes J, et al. Transcatheter versus surgical pulmonary valve replacement: a systemic review and meta-analysis. Ann Thorac Surg. 2020; 110(5):1751-1761.
43. Shahanavaz S, Balzer D, Babaliaros V, et al. Alterra adaptive prestent and SAPIEN 3 THV for congenital pulmonic valve dysfunction: an early feasibility study. JACC Cardiovasc Interv. 2020a; 13(21):2510-2524.
44. Shahanavaz S, Berger F, Jones TK, et al. Outcomes after transcatheter reintervention for dysfunction of a previously implanted transcatheter pulmonary valve. JACC Cardiovasc Interv. 2020b; 13(13):1529-1540.
45. Sorajja P, Moat N, Badhwar V, et al. Initial feasibility study of a new tanscatheter mitral prosthesis: the first 100 patients. J Am Coll Cardiol. 2019; 73(11):1250-1260.
46. Sorajja P, Whisenant B, Hamid N, et al. Transcatheter repair for patients with tricuspid regurgitation. N Engl J Med. 2023; 388(20):1833-1842.
47. Stone GW, Abraham WT, Lindenfeld J, et al. Five-year follow-up after transcatheter repair of secondary mitral regurgitation. N Engl J Med. 2023 2023; 388(22):2037-2048.
48. Stone GW, Lindenfield JA, Abraham WT, et al. Transcatheter mitral-valve repair in patients with heart failure. N Eng J Med. 2018; 379(24):2307-2318.
49. Takagi H, Hari Y, Kawai N, et al. A meta-analysis of valve-in-valve and valve-in-ring transcatheter mitral valve implantation. J Interv Cardiol. 2018; 31(6):899-906.
50. Whisenant B, Kapadia SR, Eleid MF, et al. One-year outcomes of mitral valve-in-valve using the SAPIEN 3 Transcatheter Heart Valve. JAMA Cardiol. 2020; 5(11):1245-1252.
51. Whitlow PL, Feldman T, Pedersen WR, et al.; EVEREST II Investigators. Acute and 12-month results with catheter-based mitral valve leaflet repair: the EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk study. J Am Coll Cardiol. 2012; 59(2):130-139.
52. Yoon SH, Whisenant BK, Bleiziffer S, et al. Outcomes of transcatheter mitral valve replacement for degenerated bioprostheses, failed annuloplasty rings, and mitral annular calcification. Eur Heart J. 2019; 40(5):441-451.
53. Zahid S, Ullah W, Hashem AM, et al. Transcatheter valve-in-valve implantation versus redo surgical mitral valve replacement in patients with failed mitral bioprostheses. EuroIntervention. 2022; 18(10):824-835.
54. Zia Khan M, Zahid S, Khan MU, et al. Redo surgical mitral valve replacement versus transcatheter mitral valve in valve from the National Inpatient Sample. J Am Heart Assoc. 2021; 10(17):e020948.
55. Zhou J, Li Y, Chen Z, Zhang H. Transcatheter mitral valve replacement versus redo surgery for mitral prosthesis failure: a systematic review and meta-analysis. Front Cardiovasc Med. 2023; 9:1058576.
56. Zogg CK, Hirji SA, Percy ED, et al. Comparison of postdischarge outcomes between valve-in-valve transcatheter mitral valve replacement and reoperative surgical mitral valve replacement. Am J Cardiol. 2023; 201:200-210.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Abbott Medical Devices. Clinical trial to evaluate the safety and effectiveness of using the Tendyne Transcatheter Mitral Valve System for the treatment of symptomatic mitral regurgitation (SUMMIT). NLM Identifier: NCT03433274. Last updated January 31, 2025. Available at https://www.clinicaltrials.gov/study/NCT03433274. Accessed on December 05, 2025.
2. Arbelo E, Protonotarios A, Gimeno JR, et al. 2023 ESC Guidelines for the management of cardiomyopathies. Eur Heart J. 2023; 44(37):3503-3626.
3. Baumgartner H, Backer J, Babu-Narayan SV, et al. 2020 ESC Guidelines for the management of adult congenital heart disease: the Task Force for the management of adult congenital heart disease of the European Society of Cardiology (ESC). Eur Heart J. 2020; 42(6):563-645.
4. Baumgartner H, Bonhoeffer P, De Groot NM, et al. European Society of Cardiology (ESC). ESC Guidelines for the management of grown-up congenital heart disease (new version 2010). The task force on the management of grown-up congenital heart disease of the European Society of Cardiology (ESC). Eur Heart J. 2010; 31(23):2915-57.
5. Bonow RO, Carabello BA, Kanu C, et al. 2008 Focused update incorporated into the ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (writing committee to revise the 1998 Guidelines for the Management of Patients With Valvular Heart Disease): developed in collaboration with the Society of Cardiovascular Anesthesiologists: endorsed by the Society for Cardiovascular Angiography and Interventions and the Society of Thoracic Surgeons. Circulation. 2008; 118:e523-e661.
6. Centers for Disease Control and Prevention (CDC). About Valvular Heart Disease. Updated December 05, 2024. Available at: https://www.cdc.gov/heart-disease/about/heart-valve-disease.html?CDC_AAref_Val=https://www.cdc.gov/heart-disease/about/valvular-heart-disease.html?CDC_AAref_Val=https://www.cdc.gov/heartdisease/valvular_disease.htm. Accessed on December 05, 2025. 
7. Centers for Medicare and Medicaid Services National Coverage Determination (NCD). Transcatheter Edge-to-Edge Repair (TEER) for Mitral Valve Regurgitation (20.33). Effective January 19, 2021. Available at https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?ncdid=363&ncdver=2&. Accessed on December 05, 2025.
8. Durko AP, Pibarot P, Atluri P, et al. Essential information on surgical heart valve characteristics for optimal valve prosthesis selection: expert consensus document from the European Association for Cardio-Thoracic Surgery (EACTS)-The Society of Thoracic Surgeons (STS)-American Association for Thoracic Surgery (AATS) Valve Labelling Task Force. Ann Thorac Surg. 2021; 111(1):314-326.
9. Edwards Lifesciences. The PARTNER 3 - Mitral Valve in Valve Trial - SAPIEN 3 Transcatheter Heart Valve Implantation in Patients With a Failing Mitral Bioprosthetic Valve (P3-MViV). NLM Identifier: NCT03193801. Last updated November 5, 2025. Available at https://clinicaltrials.gov/study/NCT03193801. Accessed on December 05, 2025.
10. Evalve, Abbott Vascular. Cardiovascular outcomes assessment of the MitraClip percutaneous therapy for heart failure patients with functional mitral regurgitation (The COAPT Trial) (COAPT). NLM Identifier: NCT01626079. Last updated November 27, 2023. Available at: https://clinicaltrials.gov/ct2/show/NCT01626079?term=NCT01626079&rank=1. Accessed on December 05, 2025.
11. Hausleiter J, Stolz L, Lurz P, et al. Transcatheter Tricuspid Valve Replacement. J Am Coll Cardiol. 2025; 85(3):265-291.
12. Jneid H, Chikwe J, Arnold SV, et al. 2024 ACC/AHA clinical performance and quality measures for adults with valvular and structural heart disease: a report of the American Heart Association/American College of Cardiology Joint Committee on Performance Measures. Circ Cardiovasc Qual Outcomes. 2024; 17(4):e000129.
13. Medtronic Heart Values. The Medtronic Harmony transcatheter pulmonary valve clinical study. NLM Identifier: NCT02979587. Last updated on September 19, 2025. Available at: https://www.clinicaltrials.gov/ct2/show/NCT02979587?term=NCT02979587&draw=2&rank=1. Accessed on Accessed on December 05, 2025.
14. Nishimura R, Otto CM, Bonow RO, et al. 2017 AHA/ACC focused update of the 2014 guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2017; 70(2):252-289.
15. Ommen SR, Ho CY, Asif IM, et al. 2024 AHA/ACC/AMSSM/HRS/PACES/SCMR guideline for the management of hypertrophic cardiomyopathy: a report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines. Circulation. 2024; 149(23):e1239-e1311.
16. Otto CM, Nishimura RA, Bonow RO, et al. 2020 ACC/AHA Guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2021: 143(5):e72-e227.
17. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Summary of Safety and Effectiveness and Labeling: Abbott Medical Tendyne Transcatheter Mitral Valve System. Premarket approval application No. P240042. Rockville, MD: May 23, 2025. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?ID=P240042. Accessed on June 20, 2025.
18. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Summary of Safety and Effectiveness and labeling: Abbott, TriClip G4 System. Premarket approval No. P230007. Rockville, MD. April 01, 2024. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf23/P230007B.pdf. Accessed on December 05, 2025.
19. U.S. Food and Drug Administration (FDA). Center for Devices and Radiologic Health (CDRH). Summary of Safety and Effectiveness and labeling: Boston Scientific Corporation, Sentinel Cerebral Protection System. 501(k) No. K192460. Maple Grove, MN: January 21, 2023. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf19/K192460.pdf. Accessed on December 05, 2025.
20. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Summary of Safety and Effectiveness and labeling. Medtronic CoreValve Evolute Pro System. Premarket approval application No. P130021/S029. December 05, 2017. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130021S029. Accessed on December 05, 2025.
21. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Summary of Safety and Effectiveness and labeling: Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut Pro System. Premarket Approval application No. P13022/S058. Rockville, MD: August 16, 2019. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130021S058. Accessed on December 05, 2025.
22. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Summary of Safety and Effectiveness and labeling: Medtronic CoreValve System. Premarket approval application No. P130021/S033. Rockville, MD: July 10, 2017. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130021S033. Accessed on December 05, 2025.
23. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Summary of Safety and Effectiveness and labeling: Medtronic Harmony Transcatheter Pulmonary Valve (TPV) System. Premarket approval application. P200046. Rockville, MD: September 26, 2021. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?ID=P200046. Accessed on December 05, 2025.
24. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Summary of Safety and Effectiveness and labeling. MitraClip Clip Delivery System. Premarket approval application No. P100009. Rockville, MD: October 24, 2013. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?ID=320432. Accessed on December 05, 2025.
25. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Summary of Safety and Effectiveness and labeling: Edwards EVOQUE Tricuspid Valve Replacement System. Premarket approval No. P230013. Rockville, MD. February 01, 2024. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf23/P230013A.pdf. Accessed on December 05, 2025.
26. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Summary of Safety and Effectiveness and labeling: Edwards EVOQUE Tricuspid Valve Replacement System. Premarket approval No. P230013. Rockville, MD. February 01, 2024. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf23/P230013A.pdf. Accessed on December 05, 2025.
27. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Summary of Safety and Effectiveness and labeling: Edwards SAPIEN 3 Transcatheter Heart Valve. Premarket approval No. P140031/S028. Rockville, MD. June 5, 2017. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P140031S028. Accessed on December 05, 2025.
28. U.S. Food and Drug Administration (FDA). Centers for Devices and Radiological Health (CDRH). Summary of Safety and Effectiveness and labeling: Edwards SAPIEN 3 Ultra Transcatheter Heart Valve. Premarket approval No.P140031/S074. Rockville, MD. December 27, 2018. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P140031S074. Accessed on December 05, 2025.
29. U.S. Food and Drug Administration (FDA). Center for Devices and Radiologic Health (CDRH). Summary of Safety and Effectiveness and labeling: Edwards SAPIEN XT Transcatheter Heart Valve (THV) with the NovaFlex+ Delivery System. Premarket approval application No. P130009/S037. Rockville, MD: February 29, 2016. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130009S037. Accessed on December 05, 2025.
30. U.S. Food and Drug Administration (FDA). Center for Devices and Radiologic Health (CDRH). Summary of Safety and Effectiveness and labeling: Edwards SAPIEN XT Transcatheter Heart Valve (THV) Model 9300TFX, 23, 26, and 29mm and accessories. Premarket approval application No. P130009/S057. Rockville, MD: August 18, 2016. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130009S057d.pdf. Accessed on December 05, 2025.
31. U.S. Food and Drug Administration (FDA). Center for Devices and Radiologic Health (CDRH). Summary of Safety and Effectiveness and labeling: Edwards SAPIEN 3 Transcatheter Pulmonary Valve System Premarket approval application No. P200015. Rockville, MD: August 31, 2020. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf20/P200015B.pdf. Accessed on December 05, 2025.
32. U.S. Food and Drug Administration (FDA). Center for Devices and Radiologic Health (CDRH). Summary of Safety and Effectiveness and labeling: Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve System. Summary of Safety and Effectiveness. No. P140031/S162. Rockville, MD: May 23, 2024. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf14/P140031S162B.pdf. Accessed on December 05, 2025.
33. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Summary of Safety and Effectiveness and Labeling: Edwards SAPIEN 3 Transcatheter Heart Valve System. Premarket approval application No. P140031/S182. Rockville, MD: April 30, 2025. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P140031S182. Accessed on December 05, 2025.
34. U.S. Food and Drug Administration (FDA). Center for Devices and Radiologic Health (CDRH). Summary of Safety and Effectiveness and labeling: Edwards SAPIEN 3 Transcatheter Pulmonary Valve System With Alterra Adaptive Prestent. Premarket approval application No. P200015/S011. Rockville, MD: September 21, 2021. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf20/P200015A.pdf. Accessed on December 05, 2025.
35. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Summary of Safety and Effectiveness and Probable Benefit: Melody Transcatheter Pulmonary Valve (TPV), Ensemble transcatheter valve delivery system (DS). Premarket approval application No. P140017. Rockville, MD: January 27, 2015. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?ID=320589. Accessed on December 05, 2025.
36. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Summary of Safety and Effectiveness and Probable Benefit: Melody Transcatheter Pulmonary Valve (TPV), Ensemble transcatheter valve delivery system (DS). Premarket approval application No. P140017/2005. Rockville, MD: February 24, 2017. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf14/P140017S005B.pdf. Accessed on December 05, 2025.
37. U.S. Food and Drug Administration (FDA). Medical Devices. MitraClip NT Clip Delivery System and MitraClip NTR/XTR Clip Delivery System - P100009/S038. Rockville, MD: February 22, 2021. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?ID=P100009S038. Accessed on December 05, 2025.
38. Vahanian, A, Baumgartner H, Praz F, et al. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. EuroIntervention. 2022; 17(14):e1126-e1196.
39. Vahanian A, Beyersdorf F, Praz F, et al. 2024 ESC/EACTS guidelines for the management of valvular heart disease. Eur Heart J. 2024; 45(15):1255-1356.

1. American Heart Association. Available at: https://www.heart.org/. Accessed on December 05, 2025.
2. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Humanitarian Use Devices. Available at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/HumanitarianDeviceExemption/default.htm. Accessed on December 05, 2025.

Carillon Mitral Contour System
Edwards EVOQUE Tricuspid Valve Replacement System
Edwards SAPIEN XT transcatheter heart valve
Edward SAPIEN 3 transcatheter heart valve
Edward SAPIEN 3 Ultra transcatheter heart valve
Harmony Transcatheter Pulmonary Valve (TPV) System
Medtronic CoreValve Evolut PRO System
Medtronic CoreValve Evolut R System
Medtronic CoreValve Systems
Medtronic Evolut PRO+ System
Melody transcatheter pulmonary valve (TPV)
MitraClip Clip Delivery System
Percutaneous annuloplasty
Percutaneous heart valves (PHV)
Prosthetic heart valve
Right ventricular outflow tract (RVOT)
Transcatheter edge-to-edge repair (TEER)
Transcatheter heart valve (THV)
Transcatheter mitral valve repair (TMVr)
Valvular heart disease

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Federal and State law, as well as contract language, including definitions and specific contract provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. The member’s contract benefits in effect on the date that services are rendered must be used. Medical Policy, which addresses medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Medical Policy periodically.

No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, mechanical, photocopying, or otherwise, without permission from the health plan.

© CPT Only – American Medical Association