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A.2.02.30
Transcatheter mitral valve repair (TMVR) is an alternative to surgical therapy for mitral regurgitation (MR). MR is a common valvular heart disease that can result from a primary structural abnormality of the mitral valve (MV) complex or a secondary dilatation of an anatomically normal MV due to a dilated left ventricle caused by ischemic or dilated cardiomyopathy. Surgical therapy may be underutilized, particularly in patients with multiple comorbidities, suggesting that there is an unmet need for less invasive procedures for MV repair. Two devices, MitraClip™ and PASCAL™, have approval from the U.S. Food and Drug Administration for the treatment of severe symptomatic MR due to a primary abnormality of the MV (primary MR) in patients considered at prohibitive risk for surgery. MitraClip is also approved for patients with heart failure and moderate-to-severe or severe symptomatic secondary MR despite the use of maximally tolerated guideline-directed medical therapy. The Edwards SAPIEN 3 transcatheter heart valve has been approved by the U.S. Food and Drug Administration for transcatheter mitral valve-in-valve replacement (TMViVR) in patients with a failing surgical bioprosthetic mitral valve who are at high or greater risk for repeat surgery.
Mitral Regurgitation
Epidemiology and Classification
Mitral regurgitation (MR) is the second most common valvular heart disease, occurring in 7% of people older than age 75 years and accounting for 24% of all patients with valvular heart disease. MR with accompanying valvular incompetence leads to left ventricular (LV) volume overload with secondary ventricular remodeling, myocardial dysfunction, and left heart failure. Clinical signs and symptoms of dyspnea and orthopnea may also be present in patients with valvular dysfunction. MR severity is classified as mild, moderate, or severe disease on the basis of echocardiographic and/or angiographic findings (1+, 2+, and 3+ to 4+ angiographic grade, respectively).
Patients with MR generally fall into two categories: primary (also called degenerative) and secondary (also called functional) MR. Primary MR results from a primary structural abnormality in the valve, which causes it to leak. This leak may result from a floppy leaflet (called prolapse) or a ruptured cord that caused the leaflet to detach partially (called flail). Because the primary cause is a structural abnormality, most cases of primary MR are surgically corrected. Secondary MR results from LV dilatation due to ischemic or dilated cardiomyopathy. This causes the mitral valve (MV) leaflets not to coapt or meet in the center. Because the valves are structurally normal in secondary MR, correcting the dilated LV using medical therapy is the primary treatment strategy used in the U.S.
Standard Management
Surgical Management
In symptomatic patients with primary MR, surgery is the main therapy. In most cases, MV repair is preferred over replacement, as long as the valve is suitable for repair and personnel with appropriate surgical expertise are available. The American College of Cardiology and the American Heart Association have issued joint guidelines on the surgical management of MR.
The use of standard open MV repair is limited by the requirement for thoracotomy and cardiopulmonary bypass, which may not be tolerated by elderly or debilitated patients due to their underlying cardiac disease or other conditions. A single-center evaluation of 5,737 patients with severe MR in the U.S. found that 53% of patients did not have MV surgery performed, suggesting an unmet need for such patients.
Isolated MV surgery (repair or replacement) for severe chronic secondary MR is not generally recommended because there is no proven mortality reduction and an uncertain durable effect on symptoms. Recommendations from major societies regarding MV surgery in conjunction with coronary artery bypass graft surgery or surgical aortic valve replacement are weak because the current evidence is inconsistent on whether MV surgery produces a clinical benefit.
Transcatheter Mitral Valve Repair
Transcatheter approaches have been investigated to address the unmet need for less invasive MV repair, particularly among inoperable patients who face prohibitively high surgical risks due to their age or comorbidities. MV repair devices under development address various components of the MV complex and generally are performed on the beating heart without the need for cardiopulmonary bypass. Approaches to MV repair include direct leaflet repair; repair of the mitral annulus via direct annuloplasty, or indirect repair based on the annulus’s proximity to the coronary sinus. There are also devices in development to counteract ventricular remodeling, and systems designed for complete MV replacement via catheter.
Direct Leaflet Approximation
Devices currently approved by the FDA for transcatheter mitral valve repair (TMVR) undergo direct mitral leaflet repair (also referred to as transcatheter edge-to-edge repair). Of the transcatheter MV repair devices under investigation, the MitraClip has the largest body of evidence evaluating its use; it has been in use in Europe since 2008. The MitraClip system is deployed percutaneously and approximates the open Alfieri edge-to-edge repair approach to treating MR. The delivery system consists of a catheter, a steerable sleeve, and the MitraClip device, which is a 4-mm wide clip fabricated from a cobalt-chromium alloy and polypropylene fabric. The MitraClip is deployed via a transfemoral approach, with transseptal puncture used to access the left side of the heart and the MV. Placement of the MitraClip leads to coapting of the mitral leaflets, thus creating a double-orifice valve.
The PASCAL (PAddles Spacer Clasps ALfieri) Mitral Repair System (Edwards Lifesciences) is also a direct coaptation device and works in a similar manner to the MitraClip system. PASCAL has been in clinical use since 2016 and was approved for use in Europe in 2019. The delivery system consists of a 10-mm central spacer that attaches to the MV leaflets by 2 paddles and clasps.
Other Mitral Valve Repair Devices
Devices for transcatheter MV repair that use different approaches are in development. Techniques to repair the mitral annulus include those that target the annulus itself (direct annuloplasty) and those that tighten the mitral annulus via manipulation of the adjacent coronary sinus (indirect annuloplasty). Indirect annuloplasty devices include the Carillon Mitral Contour System (Cardiac Dimension) and the Monarc device (Edwards Lifesciences). The CE-marked Carillon Mitral Contour System is comprised of self-expanding proximal and distal anchors connected with a nitinol bridge, with the proximal end coronary sinus ostium and the distal anchor in the great cardiac vein. The size of the connection is controlled by a manual pullback on the catheter. The Carillon system was evaluated in the Carillon Mitral Annuloplasty Device European Union Study and the follow-up Tighten the Annulus Now study, with further studies planned. The Monarc system also involves two self-expanding stents connected by a nitinol bridge, with one end implanted in the coronary sinus via the internal jugular vein and the other in the great cardiac vein. Several weeks after implantation, the biologically degradable coating over the nitinol bridge degrades, allowing the bridge to shrink and the system to shorten. It has been evaluated in the Clinical Evaluation of the Edwards Lifesciences Percutaneous Mitral Annuloplasty System for the Treatment of Mitral Regurgitation trial.
Direct annuloplasty devices include the Mitralign Percutaneous Annuloplasty System (Mitralign) and the AccuCinch® System (Guided Delivery Systems), both of which involve transcatheter placement of anchors in the MV, which are cinched or connected to narrow the mitral annulus. Other transcutaneous direct annuloplasty devices under investigation include the enCorTC™ device (MiCardia), which involves a percutaneously insertable annuloplasty ring that is adjustable using radiofrequency energy, a variation on its CE-marked enCorSQ Mitral Valve Repair System, and the Cardioband Annuloplasty System (Valtech Cardio), an implantable annuloplasty band with a transfemoral venous delivery system.
Transcatheter Mitral Valve-in-Valve Replacement
Mitral valve-in-valve replacement is a minimally invasive procedure designed to treat patients with failing surgical bioprosthetic mitral valves who are at high risk for complications with repeat open-heart surgery. The Edwards SAPIEN 3 Transcatheter Heart Valve received FDA approval in June 2017 (PMA #P140031) for patients with a failing surgical bioprosthetic mitral valve who are at high or prohibitive risk for repeat surgery. The procedure involves deploying the replacement valve within the failing bioprosthetic valve using a catheter-based transapical or transseptal approach. Once in position, the replacement valve is expanded, pushing the leaflets of the failing bioprosthetic valve aside and taking over the valve function.
Medical Management
The standard treatment for patients with chronic secondary MR is medical management. Patients with chronic secondary MR should receive standard therapy for heart failure with reduced ejection fraction; standard management includes angiotensin converting enzyme inhibitor (or angiotensin II receptor blocker or angiotensin receptor-neprilysin inhibitor), β-blocker and mineralocorticoid receptor antagonist, and diuretic therapy as needed to treat volume overload. Resynchronization therapy may provide symptomatic relief, improve LV function, and in some patients, lessen the severity of MR.
In October 2013, the MitraClip Clip Delivery System (Abbott Vascular) was approved by the FDA through the premarket approval process for treatment of “significant symptomatic mitral regurgitation (MR ≥3+) due to primary abnormality of the mitral apparatus (degenerative MR) in patients who have been determined to be at a prohibitive risk for mitral valve surgery by a heart team.”
In June 2017, the Edwards SAPIEN 3 Transcatheter Heart Valve received FDA approval through the premarket approval process for the treatment of patients with a "failing surgical bioprosthetic mitral valve who have been determined to be at high or greater risk for open-heart surgery by a heart team."
In March 2019, the FDA approved a new indication for MitraClip, for "treatment of patients with normal mitral valves who develop heart failure symptoms and moderate-to-severe or severe mitral regurgitation because of diminished left heart function (commonly known as secondary or functional mitral regurgitation) despite being treated with optimal medical therapy. Optimal medical therapy includes combinations of different heart failure medications along with, in certain patients, cardiac resynchronization therapy and implantation of cardioverter defibrillators."
In September 2022, the FDA approved the PASCAL Precision Transcatheter Valve Repair System through the premarket approval process for treatment of "significant, symptomatic mitral regurgitation (MR ≥3+) due to primary abnormality of the mitral apparatus (degenerative MR) in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team."
In March 2024, the FDA expanded the indication for the Edwards SAPIEN 3 Systems to include, "patients with a failing surgical bioprosthetic mitral valve who are at intermediate risk for open surgical therapy."
In May 2024, the FDA granted 4C Medical Technologies' AltaValve™ System dual Breakthrough Device Designation for the treatment of moderate-to-severe or severe MR, including cases with significant mitral annular calcification (MAC).
FDA product code for MitraClip and PASCAL: NKM.FDA product code for Edwards SAPIEN 3: NPV
Transcatheter mitral valve repair with a device approved by the U.S. Food and Drug Administration for use in mitral valve repair may be considered medically necessary for individuals with symptomatic, primary mitral regurgitation who are considered at prohibitive risk for open surgery (see Policy Guidelines section).
Transcatheter mitral valve repair with a device approved by the U.S. Food and Drug Administration may be considered medically necessary for individuals with heart failure and moderate-to-severe or severe symptomatic secondary mitral regurgitation despite the use of maximally tolerated guideline-directed medical therapy (see Policy Guidelines section).
Transcatheter mitral valve repair is considered investigational in all other situations.
Transcatheter mitral valve-in-valve replacement (TMViVR) with a device approved by the U.S. Food and Drug Administration is considered medically necessary for individuals when all of the following conditions are present:
Failure (stenosed, insufficient, or combined) of a surgical bioprosthetic mitral valve; AND
New York Heart Association heart failure class II, III, or IV symptoms; AND
Individual is not an operable candidate for open surgery, as documented by at least 2 cardiovascular specialists (including a cardiac surgeon); OR individual is an operable candidate but is considered at an intermediate to prohibitive surgical risk for open surgery, as documented by at least 2 cardiac specialists (including a cardiac surgeon); OR individual is considered at an intermediate to prohibitive surgical risk for open surgery (eg, repeat sternotomy) due to a history of congenital vascular anomalies AND/OR has a complex intrathoracic surgical history, as documented by at least 2 cardiovascular specialists (including a cardiac surgeon) (see Policy Guidelines).
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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
“Prohibitive risk” for open surgery may be determined based on:
Presence of a Society for Thoracic Surgeons predicted mortality risk of 12% or greater and/or
Presence of a logistic EuroSCORE of 20% or greater.
The FDA definition of high risk for open surgery is:
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.
The FDA definition of intermediate risk for open surgery is:
Society of Thoracic Surgeons (STS) predicted operative risk score of 4% or higher judged by a heart team.
Moderate to severe or severe mitral regurgitation (MR) may be determined by:
Grade 3+ (moderate) or 4+ (severe) MR confirmed by echocardiography;
New York Heart Association (NYHA) functional class II, III, or IVa (ambulatory) despite the use of stable maximal doses of guideline-directed medical therapy and cardiac resynchronization therapy (if appropriate) administered in accordance with guidelines of professional societies.
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, European Society of Cardiology/European Association for Cardio-Thoracic Surgery Guidelines for the Management of Valvular Heart Disease, American Heart Association/American College of Cardiology/Heart Failure Society of America Guideline for the Management of Heart Failure).
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.
11/20/2014: New policy added. Approved by Medical Policy Advisory Committee.
12/31/2014: Added the following new 2015 CPT codes to the Code Reference section: 33418 and 33419.
07/23/2015: Code Reference section updated for ICD-10.
06/08/2016: Policy number A.2.02.30 added.
04/01/2017: Policy description updated regarding devices. Added the following policy statement: Transcatheter mitral valve repair with a device cleared by the U.S. Food and Drug Administration for use in mitral valve repair may be considered medically necessary for patients with symptomatic, degenerative mitral regurgitation who are considered at prohibitive risk for open surgery. Investigational statement revised to state that transcatheter mitral valve repair is considered investigational in all other situations. Policy guidelines updated regarding determination of "prohibitive risk." Code Reference section updated to change the "Investigational Codes" table to "Medically Necessary Codes." Added ICD-10 procedure codes 02QG3ZZ, 02QG4ZZ, 02RG37Z, 02RG3JH, 02RG4JZ, 02UG3JZ, 02UG4JZ and ICD-10 diagnosis codes I05.0 - I05.9, I08.0, I08.1, I08.3, I08.8, I08.9, I34.0, Q23.2, Q23.3, Q23.8, and Q23.9. Removed deleted CPT codes 0343T and 0344T.
07/13/2017: Policy description updated regarding guidelines for surgical management of the mitral valve. Medically necessary policy statement updated to change "cleared" to "approved."
09/29/2017: Code Reference section updated to add new ICD-10 procedure codes 02WG37Z, 02WG38Z, 02WG3JZ, and 02WG3KZ. Effective 10/01/2017.
12/22/2017: Code Reference section updated to add new 2018 CPT code 0484T, effective 01/01/2018.
06/20/2019: Code Reference section updated to add new CPT codes 0543T and 0544T, effective 07/01/2019.
11/15/2019: Policy description updated regarding mitral regurgitation, guidelines on mitral valve surgery, and devices. Added policy statement that transcatheter mitral valve repair with a device approved by the U.S. Food and Drug Administration may be considered medically necessary for patients with heart failure and moderate-to-severe or severe symptomatic secondary mitral regurgitation despite the use of maximally tolerated guideline-directed medical therapy. Policy Guidelines updated regarding moderate to severe or severe mitral regurgitation and optimal medical therapy. Code Reference section updated to add ICD-10 diagnosis codes I50.1, I50.20 - I50.23, I50.30 - I50.33, I50.40 - I50.43, I50.810 - I50.89, and I50.9.
06/16/2020: Policy description updated. Policy statements unchanged.
10/01/2020: Code Reference section updated to add new ICD-10 procedure code 02UG3JH, effective 10/01/2020.
07/28/2021: Policy description updated to remove table regarding guidelines on mitral valve surgery. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."
06/16/2022: Policy description updated regarding devices. Medically necessary policy statements updated to change "patients" to "individuals."
06/07/2023: Policy description updated regarding devices. Policy statements unchanged.
10/01/2024: Code Reference section updated to add new ICD-10 diagnosis codes Q23.81, Q23.82, and Q23.88.
11/21/2024: Policy title changed from "Transcatheter Mitral Valve Repair" to "Transcatheter Mitral Valve Repair or Replacement." Policy description updated regarding devices and transcatheter mitral valve-in-valve replacement. Added statement that transcatheter mitral valve-in-valve replacement with a device approved by the U.S. FDA is considered medically necessary for individuals when all of the listed conditions are present. Policy Guidelines updated to add the FDA definition of high risk for open surgery.
08/11/2025: Policy description updated regarding devices. Medically necessary criteria for transcatheter mitral valve-in-valve replacement revised to change "increased surgical risk" to "intermediate to prohibitive surgical risk." Policy Guidelines updated to define intermediate risk for open surgery.
Blue Cross and Blue Shield Association Policy #2.02.30
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.
Code Number | Description |
CPT-4 | |
0345T | Transcatheter mitral valve repair percutaneous approach via the coronary sinus |
0484T | Transcatheter mitral valve implantation/replacement (TMVI) with prosthetic valve; transthoracic exposure (eg, thoracotomy, transapical) |
0543T | Transapical mitral valve repair, including transthoracic echocardiography, when performed, with placement of artificial chordae tendineae |
0544T | Transcatheter mitral valve annulus reconstruction, with implantation of adjustable annulus reconstruction device, percutaneous approach including transseptal puncture |
33418 | Transcatheter mitral valve repair, percutaneous approach, including transseptal puncture when performed; initial prosthesis |
33419 | Transcatheter mitral valve repair, percutaneous approach, including transseptal puncture when performed; additional prosthesis(es) during same session (List separately in addition to code for primary procedure) |
HCPCS | |
ICD-10 Procedure | |
02QG3ZZ | Repair mitral valve, percutaneous approach |
02QG4ZZ | Repair mitral valve, percutaneous endoscopic approach |
02RG37Z | Replacement of mitral valve with autologous tissue substitute, percutaneous approach |
02RG3JH | Replacement of mitral valve with synthetic substitute, transapical, percutaneous approach |
02RG4JZ | Replacement of mitral valve with synthetic substitute, percutaneous endoscopic approach |
02UG3JH | Supplement mitral valve with synthetic substitute, transapical, percutaneous approach |
02UG3JZ | Supplement mitral valve with synthetic substitute, percutaneous approach |
02UG4JZ | Supplement mitral valve with synthetic substitute, percutaneous endoscopic approach |
02WG37Z | Revision of autologous tissue substitute in mitral valve, percutaneous approach |
02WG38Z | Revision of zooplastic tissue in mitral valve, percutaneous approach |
02WG3JZ | Revision of synthetic substitute in mitral valve, percutaneous approach |
02WG3KZ | Revision of nonautologous tissue substitute in mitral valve, percutaneous approach |
ICD-10 Diagnosis | |
I05.0 - I05.9 | Rheumatic mitral valve diseases |
I08.0 | Rheumatic disorders of both mitral and aortic valves |
I08.1 | Rheumatic disorders of both mitral and tricuspid valves |
I08.3 | Combined rheumatic disorders of mitral, aortic and tricuspid valves |
I08.8 | Other rheumatic multiple valve diseases |
I08.9 | Rheumatic multiple valve disease, unspecified |
I34.0 | Nonrheumatic mitral (valve) insufficiency |
I50.1 | Left ventricular failure, unspecified |
I50.20 - I50.23 | Systolic (congestive) heart failure |
I50.30 - I50.33 | Diastolic (congestive) heart failure |
I50.40 - I50.43 | Combined systolic (congestive) and diastolic (congestive) heart failure |
I50.810 - I50.89 | Other heart failure |
I50.9 | Heart failure, unspecified |
Q23.2 | Congenital mitral stenosis |
Q23.3 | Congenital mitral insufficiency |
Q23.8, Q23.81, Q23.82, Q23.88 | Other congenital malformations of aortic and mitral valves (Q23.81, Q23.82, Q23.88 New 10/01/2024) (Q23.8 Deleted 09/30/2024) |
Q23.9 | Congenital malformation of aortic and mitral valves, unspecified |
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