Transcatheter Tricuspid Valve Repair or Replacement

POLICY NUMBER

A.2.02.34

DESCRIPTION

Transcatheter tricuspid valve repair or replacement is an emerging alternative to surgical therapy for patients with severe tricuspid regurgitation (TR), particularly those at elevated surgical risk. TR may result from a primary structural abnormality of the tricuspid valve or, more commonly, from secondary annular dilation and leaflet tethering due to right ventricular remodeling associated with left-sided heart failure, pulmonary hypertension, or atrial fibrillation. Surgical intervention for isolated TR is often underutilized due to high perioperative risk and limited referral, highlighting a substantial unmet need for less invasive treatment options. Two transcatheter devices, TriClip™ (Abbott) and EVOQUE™ (Edwards Lifesciences), have been developed to address this gap. TriClip, a transcatheter edge-to-edge repair system, is designed to reduce TR by approximating valve leaflets, while the EVOQUE system provides a complete transcatheter valve replacement through a self-expanding prosthesis anchored within the native valve structure. Both devices are intended for patients with severe symptomatic TR who are not suitable candidates for surgery and continue to experience symptoms despite optimized medical therapy.

Tricuspid Regurgitation

Tricuspid regurgitation (TR) refers to the backward flow of blood through the tricuspid valve due to inadequate closure of the valve during systole and is the most common indication requiring tricuspid valve repair or replacement. TR may be classified as primary, due to intrinsic abnormalities of the valve apparatus, or more commonly secondary (functional), caused by right ventricular remodeling and annular dilation. Common etiologies include pulmonary hypertension, left heart disease, atrial fibrillation, and the presence of cardiac implantable electronic devices. Clinically significant TR is common in older adults, affecting approximately 4% of individuals over age 75 and up to 7% of those over 65, with a higher prevalence in women. TR has been observed to be independently associated with increased mortality, heart failure hospitalizations, and reduced quality of life, even in moderate forms.

Treatment

Historically, treatment options for TR were limited to diuretics for symptom relief or surgical intervention in conjunction with other valve procedures. According to the current American College of Cardiology and the American Heart Association guidelines (ACC/AHA), the only Class 1 surgical indication for treating TR is in patients undergoing left-sided valve surgery; with all isolated surgeries having a class 2 level of evidence. Isolated surgical tricuspid repair or replacement has been associated with high perioperative mortality of up to10% and is infrequently pursued. Many patients are deemed inoperable due to frailty, comorbidities, or advanced disease. Until recently, there were no approved minimally invasive therapies specifically indicated for TR, leaving a large proportion of patients untreated and symptomatic despite maximal medical therapy. The emergence of transcatheter tricuspid valve interventions offers an alternative treatment with two modalities that have gained regulatory approval in the United States: transcatheter edge-to-edge repair (T-TEER) and transcatheter valve replacement (TTVR).

The Evoque™ Tricuspid Valve Replacement System (Edwards Lifesciences, Co.) and the TriClip™ G4 System (Abbott Medical) are currently the only FDA-approved devices for tricuspid valve replacement and repair. Several additional devices, the PASCAL™ Transcatheter Valve Repair System, a transcatheter edge-to-edge repair device similar to TriClip, and the Cardioband™ Tricuspid Valve Reconstruction system, anannuloplasty device, both by Edwards Lifesciences, have received CE marking but have not yet been FDA approved. The focus of this policy will be on devices that have FDA approval.

TriClip G4 System

The TriClip G4 System, manufactured by Abbott, was granted FDA Premarket Approval (PMA) on April 1, 2024 (P230007; product code NPS). The device is indicated for, “improving quality of life and functional status in patients with symptomatic severe tricuspid regurgitation despite optimal medical therapy, who are at intermediate or greater risk for surgery and in whom transcatheter edge-to-edge valve repair is clinically appropriate and is expected to reduce tricuspid regurgitation severity to moderate or less, as determined by amultidisciplinary heart team.” TriClip is derived from the MitraClip system, which served as its predicate device under compassionate use for tricuspid regurgitation. The technology adapts MitraClip’s TEER for use in the tricuspid position, providing a repair-based alternative to valve replacement.

Post-approval, TriClip is subject to two Post-Approval Studies (PAS). Continued Follow-up of the Premarket Cohort, which monitors Investigational Device Exemption (IDE) and Continued Access Protocol patients through 5 years, tracking clinical outcomes including mortality, TR grade, reintervention, New York Heart Association (NYHA) class, 6 minute walk test (6MWT), and quality-of-life metrics (KCCQ, SF-36). And a registry-based study involving 5,000 patients or all treated in the first 2 years, with a detailed subgroup of 1,000 patients tracked for 1-year outcomes. Data from years 2 to 5 will be supplemented via Centers for Medicare & Medicaid Services (CMS) claims, and a minimum enrollment of 100 patients per underrepresented racial/ethnic group is mandated.

EVOQUE Tricuspid Valve Replacement System

The Edwards EVOQUE Tricuspid Valve Replacement System received PMA from the FDA on February 1, 2024 (P230013; product code NPW). The approved indication for use is, “the improvement of health status in patients with symptomatic severe tricuspid regurgitation despite optimal medical therapy, for whom tricuspid valve replacement is deemed appropriate by a heart team.” The EVOQUE system is a TTVR device, and, unlike repair devices, it does not rely on annular or leaflet anatomy for efficacy, making it suitable for patients in whom repair is not feasible.

The FDA has imposed several post-approval requirements, most notably a registry-based study. This study will enroll at least 5,000 consecutively treated patients (or all patients treated within the first 2 years of approval, whichever is greater) into the Society of Thoracic Surgeons and the American College of Cardiology (STS/ACC) Transcatheter Valve Therapy Registry. Data will be collected for at least five years post-procedure, with one-year outcomes sourced from the registry and longer-term data linked to CMS claims. A focus of the study is on underrepresented populations, requiring at least 100 patients from each racial/ethnic group, including Black, Asian, Native American, Pacific Islander, and Hispanic/Latino patients.

Related medical policies -

• Transcatheter Mitral Valve Repair or Replacement

• Transcatheter Aortic Valve Implantation for Aortic Stenosis

POLICY

Transcatheter tricuspid edge to edge repair (T-TEER) with a device approved by the U.S. Food and Drug Administration (FDA) for use in tricuspid valve repair may be considered medically necessary for individuals with severe tricuspid regurgitation (TR) despite the use of maximally tolerated guideline-directed medical therapy who are considered at intermediate or high risk for open surgery as assessed by a heart team (see Policy Guidelines section).

Transcatheter tricuspid valve replacement (TTVR) with a device approved by the U.S. FDA may be considered medically necessary for individuals with severe TR despite the use of maximally tolerated guideline-directed medical therapy who are TTVR candidates as identified by a heart team (see Policy Guidelines section).

T-TEER and TTVR are considered investigational in all other situations.

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

The FDA definition of intermediate or high risk for open surgery is:

• High risk: Society of Thoracic Surgeons (STS) predicted operative risk score of 8% or higher or judged by a heart team, which includes an experienced cardiac surgeon and a cardiologist, to have an expected mortality risk of 15% or higher for open surgery.

• Intermediate risk: STS predicted risk of mortality between 3% and 7%.

Moderate to severe or severe tricuspid regurgitation (TR) may be defined by echocardiography; for definitions, see the table below.

5 Grade Scale for Tricuspid Regurgitation Severity

3D VCA: three-dimensional vena contracta area; EROA: effective regurgitant oriface area; PISA: proximal isovelocity surface area.

Optimal medical therapy may be determined by guidelines from specialty societies (e.g., American Heart Association/American College of Cardiology Guideline for the Management of Patients with Valvular Heart Disease or European Society of Cardiology/European Association for Cardio-Thoracic Surgery Guidelines for the Management of Valvular Heart Disease).

The composition of a heart care team should include, at minimum, the following: cardiac surgeon, interventional cardiologist, cardiologist with training and experience in heart failure management, electrophysiologic, multi-modality imaging specialists, and interventional echocardiographic.

Individuals treated with TriClip or Evoque should be part of continuing evidence development: studies must report 24-month outcomes (mortality, hospitalizations, or composite), use an active comparator, include a care management plan detailing heart team roles, and be designed to allow subgroup analyses by demographics, clinical factors, and provider characteristics.

Contraindications

The TriClip system is contraindicated in patients with intolerance (including allergy or untreatable hypersensitivity) to procedural anticoagulation, untreatable sensitivity to nickel-titanium alloy or cobalt-chromium alloy, or active endocarditis or other active infection of the tricuspid valve.

Evoque is contraindicated in individuals with active endocarditis or other active infection requiring antibiotic therapy (oral or intravenous); untreatable hypersensitivity or contraindication to any of the following: all antiplatelets, all anticoagulants, nitinol alloys (nickel and titanium), bovine tissue, glutaraldehyde, contrast media, or transesophageal echocardiography; tricuspid valve anatomy that precludes proper device deployment and functionality based on CT and echocardiographic evaluation. Patients must be able to tolerate at least one antiplatelet medication AND one anticoagulant medication.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B. appropriate with regard to standards of good medical practice; and

C. not solely for the convenience of the Member, his or her Provider; and

D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

08/15/2025: New policy added. Approved by the Medical Policy Advisory Committee.

SOURCE(S)

Blue Cross Blue Shield Association policy # 2.02.34

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Medically Necessary Codes

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