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Transcatheter Mitral Valve Repair or Replacement

Policy Number: MP-561

Latest Review Date: June 2024

Category: Surgery                                             

POLICY:

Effective on and after September 16, 2024:

Repair of Primary (Degenerative) Mitral Regurgitation

Transcatheter mitral valve repair with an FDA approved device for use in mitral valve repair may be considered medically necessary for patients with symptomatic, primary (degenerative) mitral regurgitation who are considered at prohibitive risk* for open surgery as evidenced by documentation to support risk.

Repair of Secondary (Functional) Mitral Regurgitation

Transcatheter mitral valve repair with a device approved by the U.S. Food and Drug Administration may be considered medically necessary for symptomatic, secondary (functional) mitral regurgitation who meet all of the following criteria:

  • Class II, III or IV symptoms of heart failure while on maximally tolerated guideline-directed medical therapy; AND
  • Left ventricular ejection fraction (LVEF) between 20-50%
  • Left ventricular end systolic diameter (LVESD) ≤ 70mm
  • Pulmonary artery systolic pressure ≤ 70mmHg
  • Patient is not a candidate for surgical mitral valve repair as judged by a cardiac surgeon.

Transcatheter mitral valve repair is considered investigational in all other situations.

Transapical mitral valve repair is considered investigational in all situations.

*Prohibitive risk for open surgery may be determined based on the following (to be included in supportive documentation):

  • 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.

Replacement of Mitral Valve

Transcatheter mitral valve-in-valve replacement (TMViVR) with a device approved by the U.S. FDA 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).

Effective for dates of service July 16, 2022 through September 15, 2024:

Primary (Degenerative) Mitral Regurgitation

Transcatheter mitral valve repair with an FDA approved device for use in mitral valve repair may be considered medically necessary for patients with symptomatic, primary (degenerative) mitral regurgitation who are considered at prohibitive risk* for open surgery as evidenced by documentation to support risk.

Secondary (Functional) Mitral Regurgitation

Transcatheter mitral valve repair with a device approved by the U.S. Food and Drug Administration may be considered medically necessary for symptomatic, secondary (functional) mitral regurgitation who meet all of the following criteria:

  • Class II, III or IV symptoms of heart failure while on maximally tolerated guideline-directed medical therapy; AND
  • Left ventricular ejection fraction (LVEF) between 20-50%
  • Left ventricular end systolic diameter (LVESD) ≤ 70mm
  • Pulmonary artery systolic pressure ≤ 70mmHg
  • Patient is not a candidate for surgical mitral valve repair as judged by a cardiac surgeon.

Transcatheter mitral valve repair is considered investigational in all other situations.

Transapical mitral valve repair is considered investigational in all situations.

*Prohibitive risk for open surgery may be determined based on the following (to be included in supportive documentation):

  • 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.

Replacement of Mitral Valve

Transcatheter mitral valve replacement for a native or valve-in-valve procedure is considered investigational.

Effective for dates of service June 13, 2019 - July 15, 2022:

Primary (Degenerative) Mitral Regurgitation

Transcatheter mitral valve repair with an FDA approved device for use in mitral valve repair may be considered medically necessary for patients with symptomatic, primary (degenerative) mitral regurgitation who are considered at prohibitive risk* for open surgery as evidenced by documentation to support risk.

Secondary (Functional) Mitral Regurgitation

Transcatheter mitral valve repair with a device approved by the U.S. Food and Drug Administration may be considered medically necessary for patients who meet all of the following criteria:

  • heart failure; AND
  • Moderate-to-severe or severe symptomatic secondary mitral regurgitation despite the use of maximally tolerated guideline-directed medical therapy; AND
  • Patient is not a candidate for surgical mitral valve repair as judged by a cardiac surgeon.

 

Transcatheter mitral valve repair is considered investigational in all other situations.

Transapical mitral valve repair is considered investigational in all situations.

*Prohibitive risk for open surgery may be determined based on the following (to be included in supportive documentation):

  • 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.

Replacement of Mitral Valve

Transcatheter mitral valve replacement for a native or valve-in-valve procedure is considered investigational.

DESCRIPTION OF PROCEDURE:

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 either 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 individuals over 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 3-4+ angiographic grade, respectively).

Patients with MR generally fall into 2 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. In contrast, secondary MR results from left ventricular dilatation due to ischemic or dilated cardiomyopathy. This causes the mitral value (MV) leaflets not to coapt or meet in the center. Because the valves are structurally normal in secondary MR, correcting the dilated left ventricular using medical therapy is the primary treatment strategy used in the United States.

Standard Management

Surgical Management

In symptomatic patients with primary MR, surgery is the main therapy. In most cases, repair of the MV is preferred over replacement, as long as the valve is suitable for repair and personnel with appropriate surgical expertise are available.

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. In a single-center evaluation of 5737 patients with severe MR in the United States, Goel et al (2014) 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 ages or comorbidities. MV repair devices under development address various components of the mitral valve 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 through indirect approaches 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 mitral valve replacement via catheter.

Direct Leaflet Approximation

Of the transcatheter MV repair devices under investigation, the MitraClip has the largest body of evidence evaluating its use and has been in use in Europe since 2008. The MitraClip system is a percutaneously-deployed device that approximates the open Alfieri edge-to-edge repair approach to treating MR. The delivery system consists of a delivery catheter, a steerable sleeve and the MitraClip device, which is a 4mm 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 mitral valve. 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 MV Repair Devices

Devices for transcatheter mitral valve 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 Inc., Kirkland, WA) and the Monarc device (Edwards Lifesciences, Irvine, CA). 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 manual pullback on the catheter. The Carillon system has been evaluated in the AMADEUS (Carillon Mitral Annuloplasty Device European Union Study and the follow up TITAN (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 internal jugular vein and the other end in the great cardiac vein. Several weeks following implantation, a biologically degradable coating over the Nitinol bridge degrades, allowing the bridge to shrink and the system to shorten. It was evaluated in the EVOLUTION I (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, Tewksury, MA) and the Accucinch® System (Guided Delivery Systems, Santa Clara, CA), both of which involve transcatheter placement of anchors in the mitral valve which are cinched or connected to narrow the mitral annulus. Other transcutaneous direct annuloplasty devices under investigation include the enCorTC™ device (Micardia Corporation, Irvine, CA), 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 Ltd., Or- Yehuda, Israel), an implantable annuloplasty band with a transfemoral venous delivery system.

Transcatheter MV 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 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), b-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.

KEY POINTS:

The most recent literature review covers the period through March 4, 2024.

Summary of Evidence

For individuals who have symptomatic primary MR and at prohibitive risk for open surgery who receive TMVR using MitraClip or PASCAL, the evidence includes a non-inferiority RCT and a single-arm prospective cohort with historical cohort and registry studies. Relevant outcomes are overall survival, morbid events, functional outcomes, and treatment-related morbidity. The primary evidence includes the pivotal EVEREST II HRR and EVEREST II REALISM studies, the Transcatheter Valve Therapy Registry study, and the CLASP IID/IIF study. These studies have demonstrated that MitraClip implantation is feasible, with a procedural success rate greater than 90%, 30 day mortality ranging from 2.3%-6.4% (less than predicted STS mortality risk score for MR repair or replacement; range, 9.5%-13.2%), postimplantation MR severity grade of 2+ or less in 82% to 93% of patients, and a clinically meaningful gain in quality of life (5-6 point gains in 36 Item Short Form Health Survey Scores). At 1 year, freedom from death and MR more than 2+ was achieved in 61% of patients but the 1-year mortality or heart failure hospitalization rates remain considerably high (38%). Conclusions related to the treatment effect on mortality based on historical controls cannot be made because the control groups did not provide unbiased or precise estimates of the natural history of patients eligible to receive MitraClip. Given that primary MR is a mechanical problem and there is no effective medical therapy, a randomized controlled trial (RCT) comparing MitraClip with medical management is not feasible or ethical. The post marketing data from the United States is supportive that MitraClip surgery is being performed with short-term effectiveness and safety in select patient population. The CLASP IID/IIF randomized cohort demonstrated that PASCAL is noninferior to MitraClip in safety and effectiveness for patients with primary MR at prohibitive surgical risk, and the single-arm registry cohort demonstrated that PASCAL is safe and effective in patients with complex mitral valve (MV) anatomy precluding the use of MitraClip. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have heart failure and symptomatic secondary mitral regurgitation (SMR) despite the use of maximally tolerated guideline-directed medical therapy who receive TMVR using MitraClip, the evidence includes a systematic review, two RCTS, and multiple observational studies. The relevant outcomes are OS, morbid events, functional outcomes, and treatment-related morbidity. The trials had conflicting results potentially related to differences in primary outcomes.  The larger trial, with patients selected for nonresponse to maximally tolerated therapy, found a significant benefit for MitraClip up to 5 years compared to medical therapy alone, including benefits in OS and hospitalizations.  Improvements in MR severity, quality of life measures, and functional capacity persisted to 36 months in patients who received TMVR. The systematic review confirmed the benefit of MitraClip found in the larger RCT, but had important methodological limitations. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have symptomatic primary or secondary MR and are surgical candidates who receive TMVR using MitraClip, the evidence includes a systematic review, one RCT and a retrospective comparative observational study in individuals aged >/= 75 years of age. Relevant outcomes are overall survival, morbid events, functional outcomes, and treatment-related morbidity. The RCT found that MitraClip did not reduce MR as often or as completely as the surgical control, although it could be safely implanted and was associated with fewer adverse events at 1 year. Long-term follow-up from the RCT showed that significantly more MitraClip patients required surgery for MV dysfunction than conventional surgery patients. For these reasons, this single trial is not definitive in demonstrating improved clinical outcomes with MitraClip compared with surgery. Additional RCTs are needed to corroborate these results. The observational study in individuals aged >/= 75 years of age found that although MitraClip was associated with improved 1 year survival and a lower rate of all acute complications compared with surgical repair, it had lower 5 year survival and greater MR recurrence. The evidence is insufficient to determine that the technology results in an improvement in the net health outcomes.

For individuals who have symptomatic primary or secondary MR who receive TMVR with devices other than MitraClip or PASCAL, the evidence includes a randomized study, non-randomized prospective studies, and noncomparative feasibility studies. Relevant outcomes are overall survival, morbid events, functional outcomes, and treatment-related morbidity. The randomized, sham-controlled trial for the indirect annuloplasty device Carillon also offers promising safety data, however further studies are needed to determine efficacy and long-term outcomes. The evidence is insufficient to determine that the technology results in an improvement in the net health outcomes.

For individuals who have transapical mitral valve repair, the evidence includes systematic reviews, prospective studies, and several smaller studies for feasibility and outcome.  One retrospective study compared transapical MV repair to conventional surgery; however, bias was noted for patient selection resulting in a small sample size that affected the generalizability of study results. While the current evidence shows this procedure may be feasible, additional well designed, long term studies are needed. The evidence is insufficient to determine that the technology results in an improvement in the net health outcomes.

Transcatheter Mitral Valve Replacement

For individuals who have valve dysfunction and mitral stenosis or regurgitation after prior bioprosthetic mitral valve replacement, who are not candidates for redo surgical mitral valve replacement (rSMVR), and who receive a transcatheter mitral valve-in-valve replacement (TMViVR) using an FDA-approved device, the evidence includes 2 meta-analyses, 8 comparative retrospective cohort studies, and 9 observational studies. Relevant outcomes are OS, morbid events, functional outcomes, and treatment-related morbidity. The meta-analyses had mixed early-term findings, with one observing a benefit for in-hospital mortality favoring TMViVR over rSMVR, but at 30 days, 1-year, and 2-year follow-up, no difference between groups in OS was observed in either review. Both analyses found that complications of stroke, renal dysfunction, vascular complications, pacemaker implantation, and bleeding were more common in the rSMVR group. The comparative studies generally found that mortality was equivalent or favored TMViVR through1-year follow-up; however, several studies that reported longer-term outcomes observed that the trend in mortality was reversed with numerically higher rates in the TMViVR group. TMViVR was associated with a shorter hospital or ICU stay than rSMVR. Several adverse events (acute kidney injury, cardiac arrest, cardiogenic shock, major bleeding, pacemaker implantation, pneumonia, sepsis, stroke, and vascular complications) were more commonly reported in the rSMVR group compared to TMViVR. These results were supported by observational data, which provided data on mortality, functional outcomes, and complications through up to 7 years post-implantation. The evidence base is limited primarily by the lack of experimental studies, but assigning patients who are at high or prohibitive risk for open surgery to rSMVR is ethically prohibitive so retrospective comparisons will likely continue to represent the best available evidence for this intervention. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

The American College of Cardiology and American Heart Association

In 2020, the American College of Cardiology and American Heart Association presented updated expert consensus on the management of mitral regurgitation (MR). The recommendations are as follows:

"At present, transcatheter mitral repair using an edge-to-edge clip device can be considered for the treatment of patients with primary MR and severe symptoms who are felt to be poor surgical candidates. Surgical or transcatheter treatment for secondary MR is undertaken only after appropriate medical and device therapies have been instituted and optimized, as judged by the multidisciplinary team with input from a cardiologist with experience managing heart failure and MR."

In 2020, the American College of Cardiology and American Heart Association released updated guidelines on the management of valvular heart disease. The guidelines state that TMVR is of benefit to patients with severely symptomatic primary mitral regurgitation who are at high or prohibitive risk for surgery, and to a subset of patients with secondary mitral regurgitation who remain severely symptomatic despite guideline-directed management and therapy for heart failure.  Individuals who have prosthetic valve stenosis are recommended to be offered revision surgery, but for severely symptomatic patients who are at high risk for surgery, a transcatheter aortic valve-in-valve procedure may be reasonable (B level of evidence, moderate class of recommendation); no recommendation is given regarding mitral valve-in-valve procedures. Relevant recommendations on interventions for primary and secondary MR, and prosthetic valve stenosis are shown in the table below.

Recommendations on Interventions for Primary and Secondary Mitral Regurgitation

Recommendation

COR

LOE

Primary MR

In symptomatic patients with severe primary MR (Stage D), mitral valve intervention is recommended irrespective of LV systolic function

1 (Strong)

B-NR1

In asymptomatic patients with severe primary MR and LV systolic dysfunction (LVEF <60%, LVESD >40 mm) (Stage C2), mitral valve surgery is recommended

1 (Strong)

B-NR1

In patients with severe primary MR for whom surgery is indicated, mitral valve repair is recommended in preference to mitral valve replacement when the anatomic cause of MR is degenerative disease, if a successful and durable repair is possible

1 (Strong)

B-NR1

In asymptomatic patients with severe primary MR and normal LV systolic function (LVEF >60% and LVESD >40 mm) (Stage C1), mitral valve repair is reasonable when the likelihood of a successful and durable repair without residual MR is >95% with an expected mortality rate of <1%, when it can be performed at a Primary or Comprehensive Valve Center

2a (Moderate)

B-NR1

In asymptomatic patients with severe primary MR and normal LV systolic function (LVEF >60% and LVESD <40 mm) (Stage C1) but with a progressive increase in LV size or decrease in EF on >3 serial imaging studies, mitral valve surgery may be considered irrespective of the probability of a successful and durable repair

2b (Weak)

C-LD2

In severely symptomatic patients (NYHA class III or IV) with primary severe MR and high or prohibitive surgical risk, TEER is reasonable if mitral valve anatomy is favorable for the repair procedure and patient life expectancy is at least 1 year

2a (Moderate)

B-NR1

In symptomatic patients with severe primary MR attributable to rheumatic valve disease, mitral valve repair may be considered at a Comprehensive Valve Center by an experienced team when surgical treatment is indicated, if a durable and successful repair is likely

2b (Weak)

B-NR1

In patients with severe primary MR where leaflet pathology is limited to less than one half the posterior leaflet, mitral valve replacement should not be performed unless mitral valve repair has been attempted at a Primary or Comprehensive Valve Center and was unsuccessful

3:Harm (Strong

B-NR1

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 mmHg

2a (Moderate)

B-R3

In patients with severe secondary MR (Stages C and D), mitral valve surgery is reasonable when CABG is undertaken for the treatment of myocardial ischemia

2a (Moderate)

B-NR1

In patients with chronic severe secondary MR from atrial annular dilation with preserved LV systolic function (LVEF >50%) who have severe persistent symptoms (NYHA class III or IV) despite therapy for HF and therapy for associated AF or other comorbidities (Stage D), mitral valve surgery may be considered

2b (Weak)

B-NR1

In patients with chronic severe secondary MR related to LV systolic dysfunction (LVEF <50%) who have persistent severe symptoms (NYHA class III or IV) while on optimal GDMT for HF (Stage D), mitral valve surgery may be considered

2b (Weak)

B-NR1

In patients with CAD and chronic severe secondary MR related to LV systolic dysfunction (LVEF <50%) (Stage D) who are undergoing mitral valve surgery because of severe symptoms (NYHA class III or IV) that persist despite GDMT for HF, chordal-sparing mitral valve replacement may be reasonable to choose over downsized annuloplasty repair

2b (Weak)

B-R3
Intervention for Prosthetic Valve Stenosis    
In patients with symptomatic severe stenosis of a bioprosthetic or mechanical prosthetic valve, repeat surgical intervention is indicated unless the surgical risk is high or prohibitive 1 (Strong) B-NR
For severely symptomatic patients with bioprosthetic aortic valve stenosis and high or prohibitive surgical risk, a transcatheter ViV procedure is reasonable when performed at a comprehensive valve center 2a (Moderate) B-NR
For patients with significant bioprosthetic valve stenosis attributable to suspected or documented valve thrombosis, oral anticoagulation with a VKA is reasonable 2a (Moderate) B-NR

Source: Adapted from Otto et al (2020) 1 Moderate, nonrandomized; 2  Limited data; 3Moderate, randomized. CABG: coronary artery bypass graft; CAD: coronary artery disease; COR: class of recommendation; GDMT: guideline-directed medical therapy; HF: heart failure; LOE: level of evidence; LV: left ventricular; LVEF: left ventricular ejection fraction; LVESD: left ventricular end-systolic diameters; MR: mitral regurgitation; MV: mitral valve; NYHA: New York Heart Association; TEE: transesophageal echocardiogram; TEER: transcatheter edge-to-edge repair

American College of Cardiology, American Association for Thoracic Surgery, et al

The ACC, American Association for Thoracic Surgery, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons released a position statement on transcatheter therapies for MR in 2014. This statement outlines critical components for successful transcatheter MR therapies and recommends ongoing research and inclusion of all patients treated with transcatheter MR therapies in a disease registry.

The European Society of Cardiology and the European Association for Cardio-Thoracic Surgery

The European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) issued guidelines on the management of valvular heart disease in 2022. A new position on the management of prosthetic valve dysfunction was issued, stating, "Transcatheter valve-in-valve implantation in the mitral and tricuspid position may be considered in selected patients at high risk for surgical intervention." This recommendation was given a class IIb recommendation, indicating that there is conflicting evidence about the usefulness or efficacy of this treatment, with the opinion being supported by less well-established evidence.

National Institute for Health and Care Excellence

The NICE guideline on heart valve disease management (2021) makes the following recommendations related to TMVR:

"1.5.10 - Consider transcatheter edge-to-edge repair, if suitable, for adults with severe primary mitral regurgitation and symptoms, if surgery is unsuitable.

1.5.14 - Consider transcatheter mitral edge-to-edge repair for adults with heart failure and severe secondary mitral regurgitation, if surgery is unsuitable and they remain symptomatic on medical management."

Another NICE guideline was issued in 2021 on the use of transapical transcathter mitral valve-in-valve implantation for a failed surgically implanted mitral valve bioprosthesis:

 

"1.1 - Evidence on the safety of transapical transcatheter mitral valve-in-valve implantation for a failed surgically implanted mitral valve bioprosthesis is adequate and shows some serious but well‑recognised complications. Evidence on its efficacy is limited in quality. So, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research."

 

"1.4 - Patient selection should be done by a multidisciplinary team which must include interventional cardiologists experienced in the procedure, cardiac surgeons, an expert in cardiac imaging, and where appropriate, a cardiac an aesthetist and a specialist in medicine for older people. The multidisciplinary team should determine the risk level for each patient and the device most suitable for them."

 

"1.6 - The procedure is technically challenging and should only be done in specialised centres, and only by clinical teams with special training and experience in complex endovascular cardiac interventions, including regular experience in transcatheter valve implantation procedures. Centres doing these procedures should have cardiac surgical support for emergency treatment of complications and subsequent patient care."

 

"1.7 - NICE encourages further research into transapical transcatheter mitral valve-in-valve implantation for a failed surgically implanted mitral valve bioprosthesis. Studies should include details on patient selection, type and size of valve used, functional outcomes (New York Heart Association functional class, mitral valve regurgitation), quality of life, patient‑reported outcome measures, survival and complications. Studies should report long‑term follow up of clinical outcomes and valve durability. NICE may update this guidance on publication of further evidence."

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Transcatheter Mitral Valve repair, MitraClip, mitral regurgitation, MR, mitral valve replacement, PASCAL

APPROVED BY GOVERNING BODIES:

In October 2013, the MitraClip® Clip Delivery System (Abbott Vascular, Menlo Park, CA) was approved by the U.S. Food and Drug Administration (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.” FDA product code: NKM.

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."

Several devices are in clinical trials or being studied such as Permavalve™ (MicroInterventional Devices).  It is currently under investigation in the United States and is delivered via the transapical approach.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP:  Special benefit consideration may apply.  Refer to member’s benefit plan. 

CURRENT CODING:

CPT Codes:

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)

0345T

Transcatheter mitral valve repair percutaneous approach via the coronary sinus

0543T

Transapical mitral valve repair, including transthoracic echocardiography, when performed, with placement of artificial chordae tendineae

0483T

Transcatheter mitral valve implantation/replacement (TMVI) with prosthetic valve; percutaneous approach, including transseptal puncture, when performed

0484T

Transcatheter mitral valve implantation/replacement (TMVI) with prosthetic valve; transthoracic exposure (eg, thoracotomy, transapical)

REFERENCES:

  1. Ahmed A, Abdel-Aziz T, AlAsaad M, et al. Transapical off-pump mitral valve repair with NeoChord implantation: A systematic review. J Card Surg. 2021 Apr;36(4):1492-1498.
  2. Akodad M, Trpkov C, Cheung A, et al. Valve-in-Valve Transcatheter Mitral Valve Replacement: A Large First-in-Human 13-Year Experience. Can J Cardiol. Dec 2023; 39(12): 1959-1970.
  3. Alozie A, Paranskaya L, Westphal B, et al. Clinical outcomes of conventional surgery versus MitraClip(R) therapy for moderate to severe symptomatic mitral valve regurgitation in the elderly population: an institutional experience. BMC Cardiovasc Disord. Mar 20 2017; 17(1):85.
  4. Aoun J, Reardon MJ, Goel SS. Transcatheter mitral valve replacement: an update. Curr Opin Cardiol. 2021 Jul 1;36(4):384-389.
  5. Atianzar K, Zhang M, Newhart Z, Gafoor, SS. Why Did COAPT Win While MITRA-FR Failed? Defining the Appropriate Patient Population for MitraClip. Interv Cardiol, 2019 Mar 13;14(1). 
  6. Bail DH. (Meta)-analysis of safety and efficacy following edge-to-edge mitral valve repair using the MitraClip system. J Interv Cardiol. Feb 2015; 28(1):69-75.
  7. Bail DH, Doebler K. The MitraClip System: a systematic review of indications, procedural requirements, and guidelines. Thorac Cardiovasc Surg. Feb 2014;62(1):18-25.
  8. Baumgartner H, Falk V, Bax J, et al. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. Sep 21 2017;38(36):2739-2791.
  9. Bonow RO, Carabello BA, Chatterjee K 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). Endorsed by the Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol 2008; 52(13):e1-142.
  10. Bonow RO, O'Gara PT, Adams DH, et al. 2020 Focused Update of the 2017 ACC Expert Consensus Decision Pathway on the Management of Mitral Regurgitation: A Report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. May 05 2020; 75(17): 2236-2270.
  11. Buzzatti N, Van Hemelrijck M, Denti P, et al. Transcatheter or surgical repair for degenerative mitral regurgitation in elderly patients: A propensity-weighted analysis. J Thorac Cardiovasc Surg. Jul 2019; 158(1): 86-94.e1.
  12. Chan PH, She HL, Alegria-Barrero E et al. Real-world experience of MitraClip for treatment of severe mitral regurgitation. Circ J 2012; 76(10):2488-93.
  13. Chiam PT, Ruiz CE. Percutaneous transcatheter mitral valve repair: a classification of the technology. JACC Cardiovasc Interv 2011; 4(1):1-13.
  14. Corpataux N, Winkel MG, Kassar M, et al. The PASCAL Device-Early Experience with a Leaflet Approximation Device: What Are theBenefits/Limitations Compared with the MitraClip?. Curr Cardiol Rep. Jun 27 2020; 22(8): 74.
  15. Diodato MD, Moon MR, Pasque MK, et al. Repair of ischemic mitral regurgitation does not increase mortality or improve long-term survival in patients undergoing coronary artery revascularization: a propensity analysis. Ann Thorac Surg. Sep 2004;78(3):794-799; discussion 794-799.
  16. D’Onofrio A, Mastro F, Nadali M, et al. Transpical beating heart mitral valve repairs versus conventional surgery: a propensity-matched study. Interact Cardiovasc Thorac Surg. 2022 Jun 15;35(1) ):ivac053. doi: 10.1093/icvts/ivac053.
  17. Eleid MF, Wang DD, Pursnani A, et al. 2-Year Outcomes of Transcatheter Mitral Valve Replacement in Patients With Annular Calcification, Rings, and Bioprostheses. J Am Coll Cardiol. Dec 06 2022; 80(23): 2171-2183.
  18. Enta Y, Nakamura M. Transcatheter mitral valve replacement. J Cardiol. 2021 Jun;77(6): 555-564.
  19. Estevez-Loureiro R, Franzen O, Winter R et al. Echocardiographic and clinical outcomes of central versus noncentral percutaneous edge-to-edge repair of degenerative mitral regurgitation. J Am Coll Cardiol 2013; 62(25):2370-7.
  20. FDA. Edwards Sapein 3 Transcatheter Heart Valve, Summary of Safety and Effectiveness Data (SSED).1997; https://www.accessdata.fda.gov/cdrh_docs/pdf14/P140031S028B.pdf.

  21. FDA. MitraClip NT clip delivery system and mitraclip NTR/XTR clip delivery system. Available at: https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm633474.htm.

  22. FDA. Premarket Approval. MitraClip NT Clip Delivery System and MitraClip :NTR/XTR Clip Delivery System. Available online at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100009S028.

  23. FDA. Summary of Safety and Effectiveness Data: Mitral Valve Repair Device. 2013. Available online at: www.accessdata.fda.gov/cdrh_docs/pdf10/P100009b.pdf. 

  24. FDA. Summary of Safety and Effectiveness Data (SSED): Mitral Valve Repair Device. 2022;https://www.accessdata.fda.gov/cdrh_docs/pdf22/P220003B.pdf. 
  25. Fedak PWM, McCarthy PM, Bonow RO. Evolving concepts and technologies in mitral valve repair. Circulation 2008; 117(7):963-74.
  26. Feldman T, Foster E, Glower DD et al. Percutaneous repair or surgery for mitral regurgitation. N Engl J Med 2011; 364(15):1395-406.
  27. Feldman T, Kar S, Elmariah S, et al. Randomized comparison of percutaneous repair and surgery for mitral regurgitation: 5-Year results of EVEREST II. J Am Coll Cardiol. Dec 29 2015; 66(25):2844-2854.
  28. 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):2134-40.
  29. Gercek M, Roder F, Rudolph TK, et al. PASCAL mitral valve repair system versus MitraClip: comparison of transcatheter edge-to-edge strategies incomplex primary mitral regurgitation. Clin Res Cardiol. Dec 2021; 110(12): 1890-1899.
  30. Gill J, Zahra F, Retzer E. In-Hospital Outcomes and Predictors of Mortality for Redo Surgical Mitral Valve Replacement Versus Transcatheter Mitral Valve-in-Valve Replacement. Am J Cardiol. Aug 01 2022; 176: 89-95.
  31. Glower DD, Kar S, Trento A, et al. Percutaneous mitral valve repair for mitral regurgitation in high-risk patients: results of the EVEREST II study. J Am Coll Cardiol. Jul 15 2014; 64(2):172-181.
  32. Goel SS, Bajaj N, Aggarwal B et al. Prevalence and outcomes of unoperated patients with severe symptomatic mitral regurgitation and heart failure: comprehensive analysis to determine potential role of mitraclip for this unmet need. J Am Coll Cardiol 2013.
  33. Grasso C, Ohno Y, Attizzani GF, et al. Percutaneous mitral valve repair with the MitraClip system for severe mitral regurgitation in patients with surgical mitral valve repair failure. J Am Coll Cardiol. Mar 4 2014;63(8):836-838.
  34. 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. Sep 25 2023; 16(18): 2211-2227.
  35. Guerrero M, Pursnani A, Narang A, et al. Prospective Evaluation of Transseptal TMVR for Failed Surgical Bioprostheses: MITRAL Trial Valve-in-Valve Arm 1-Year Outcomes. JACC Cardiovasc Interv. Apr 26 2021; 14(8): 859-872.
  36. Harnek J, Webb JG, Kuck KH et al. Transcatheter implantation of the MONARC coronary sinus device for mitral regurgitation: 1-year results from the EVOLUTION phase I study (Clinical Evaluation of the Edwards Lifesciences Percutaneous Mitral Annuloplasty System for the Treatment of Mitral Regurgitation). JACC Cardiovasc Interv 2011; 4(1):115-22.
  37. Hausleiter J, Lim DS, Gillam LD, et al. Transcatheter Edge-to-Edge Repair in Patients With Anatomically Complex Degenerative Mitral Regurgitation. J Am Coll Cardiol. Feb 07 2023; 81(5): 431-442.
  38. Hell MM, Wild MG, Baldus S, et al. Transapical Mitral Valve Replacement: 1-Year Results of the Real-World Tendyne European Experience Registry. JACC Cardiovasc Interv. Mar 11 2024; 17(5): 648-661.
  39. 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. Feb 15 2023; 189: 98-107.
  40. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
  41. Iung B, Armoiry X, Vahanian A, et al. Percutaneous repair or medical treatment for secondary mitral regurgitation: outcomes at 2 years. Eur J Heart Fail. Dec 2019; 21(12): 1619-1627.
  42. Kamioka N, Babaliaros V, Morse MA, et al. Comparison of Clinical and Echocardiographic Outcomes After Surgical Redo Mitral Valve Replacement and Transcatheter Mitral Valve-in-Valve Therapy. JACC Cardiovasc Interv. Jun 25 2018; 11(12): 1131-1138.
  43. Khan MS, Siddiqi TJ, Butler J, et al. Functional outcomes with Carillon device over 1 year in patients with functional mitral regurgitation of Grades 2+ to4+: results from the REDUCE-FMR trial. ESC Heart Fail. Apr 2021; 8(2): 872-878.
  44. Kumar A, Al-Khafaji J, Shariff M, et al. Percutaneous mitral valve repair for secondary mitral valve regurgitation: A systematic review and meta-analysis. Eur J Intern Med. Feb 21 2020.
  45. Lim S, Kar S, Fail P, et al. The EVEREST II high surgical risk cohort: effectiveness of transcatheter reduction of significant mitral regurgitation in high surgical risk patients. J Am Coll Cardiol. 2013;61(10 Suppl):E1958.
  46. Lim DS, Kar S, Spargias K, et al. Transcatheter Valve Repair for Patients With Mitral Regurgitation: 30-Day Results of the CLASP Study. JACCCardiovasc Interv. Jul 22 2019; 12(14): 1369-1378.
  47. Lim DS, Reynolds MR, Feldman T, et al. Improved functional status and quality of life in prohibitive surgical risk patients with degenerative mitral regurgitation after transcatheter mitral valve repair. J Am Coll Cardiol. Jul 15 2014; 64(2):182-192.
  48. Lim DS, Smith RL, Gillam LD, et al. Randomized Comparison of Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation in Prohibitive Surgical Risk Patients. JACC Cardiovasc Interv. Dec 26 2022; 15(24): 2523-2536.
  49. Mack MJ, Lindenfeld J, Abraham WT, et al. 3-Year Outcomes of Transcatheter Mitral Valve Repair in Patients With Heart Failure. J Am Coll Cardiol. Mar 02 2021;77(8): 1029-1040.
  50. Mauri L, Foster E, Glower DD et al. 4-year results of a randomized controlled trial of percutaneous repair versus surgery for mitral regurgitation. J Am Coll Cardiol 2013; 62(4):317-28.
  51. Mauri L, Garg 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):23-9.
  52. McCarthy PM, Whisenant B, Asgar AW, et al. Percutaneous MitraClip Device or Surgical Mitral Valve Repair in Patients With Primary MitralRegurgitation Who Are Candidates for Surgery: Design and Rationale of the REPAIR MR Trial. J Am Heart Assoc. Feb 21 2023; 12(4): e027504.
  53. Mihaljevic T, Lam BK, Rajeswaran J, et al. Impact of mitral valve annuloplasty combined with revascularization in patients with functional ischemic mitral regurgitation. J Am Coll Cardiol. Jun 5 2007;49(22):2191-2201.
  54. Muller DW, 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 Nov9;78(19):1847-1859.
  55. Munkholm-Larsen S, Wan B, Tian DH, et al. A systematic review on the safety and efficacy of percutaneous edge-to-edge mitral valve repair with the MitraClip system for high surgical risk candidates. Heart. Mar 2014; 100(6):473-478.
  56. Murzi M, Cerillo AG, Gasbarri T, et al. Antegrade and retrograde perfusion in minimally invasive mitral valve surgery with transthoracic aortic clamping: a single-institution experience with 1632 patients over 12 years. Interact Cardiovasc Thorac Surg. Mar 01 2017; 24(3): 363-368.
  57. National Institute for Health and Care Excellence (NICE). Heart valve disease presenting in adults: investigation and management [NG208]. 2021;https://www.nice.org.uk/guidance/ng208/chapter/Recommendations. 
  58. National Institute for Health and Care Excellence (NICE). Transapical transcatheter mitral valve-in-valve implantation for a failed surgically implanted mitral valve bioprosthesis [IPG706]. 2021; https://www.nice.org.uk/guidance/ipg706.
  59. Nishimura, RR, Bonow, RR. Percutaneous Repair of Secondary Mitral Regurgitation - A Tale of Two Trials. N. Engl. J. Med., 2018 Dec 24;379(24).
  60. Nishimura RA, Otto CM, Bonow RO et al. 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation 2014; 129(23):2440-92.
  61. Nishimura RA, Otto CM, Bonow RO, et al. 2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. Jul 11 2017;70(2):252-289.
  62. Obadia J, Messika-Zeitoun D, Leurent G, et al. Percutaneous Repair or Medical Treatment for Secondary Mitral Regurgitation. N. Engl. J. Med., 2018 Aug 28;379(24). 
  63. O'Gara PT, Calhoon JH, Moon MR et al. Transcatheter therapies for mitral regurgitation: a professional society overview from the American College of Cardiology, The American Association for Thoracic Surgery, Society for Cardiovascular Angiography and Interventions Foundation, and The Society of Thoracic Surgeons. J Thorac Cardiovasc Surg 2014; 147(3):837- 49.
  64. Orban M, Rottbauer W, Williams M, et al. Transcatheter edge-to-edge repair for secondary mitral regurgitation with third-generation devices in heartfailure patients - results from the Global EXPAND Post-Market study. Eur J Heart Fail. Mar 2023; 25(3): 411-421.
  65. 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 AmericanCollege of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. Feb 02 2021; 143(5): e72-e227.
  66. Philip F, Athappan G, Tuzcu EM, et al. MitraClip for severe symptomatic mitral regurgitation in patients at high surgical risk: a comprehensive systematic review. Catheter Cardiovasc Interv. Oct 1 2014; 84(4):581-590.
  67. Puls M, Lubos E, Boekstegers P, et al. One-year outcomes and predictors of mortality after MitraClip therapy in contemporary clinical practice: results from the German transcatheter mitral valve interventions registry. Eur Heart J. Feb 21 2016; 37(8):703-712.
  68. Reichenspurner H, Schillinger W, Baldus S et al. Clinical outcomes through 12 months in patients with degenerative mitral regurgitation treated with the MitraClip(R) device in the ACCESS-EUrope Phase I trial. Eur J Cardiothorac Surg 2013; 44(4):e280-8.
  69. Schamroth Pravda N, Mishaev R, Levi A, et al. Five-Year Outcomes of Patients With Mitral Structural Valve Deterioration Treated With Transcatheter Valve in Valve Implantation - A Single Center Prospective Registry. Front Cardiovasc Med. 2022; 9: 883242.
  70. Schofer J, Siminiak T, Haude M et al. Percutaneous mitral annuloplasty for functional mitral regurgitation: results of the CARILLON Mitral Annuloplasty Device European Union Study. Circulation 2009; 120(4):326-33.
  71. Simard T, Lloyd J, Crestanello J, et al. Five-year outcomes of transcatheter mitral valve implantation and redo surgery for mitral prosthesis degeneration. Catheter Cardiovasc Interv. Apr 2022; 99(5): 1659-1665.
  72. Siminiak T, Wu JC, Haude M et al. Treatment of functional mitral regurgitation by percutaneous annuloplasty: results of the TITAN Trial. Eur J Heart Fail 2012; 14(8):931-8.
  73. Simonato M, Whisenant B, Ribeiro HB, et al. Transcatheter Mitral Valve Replacement After Surgical Repair or Replacement: ComprehensiveMidterm Evaluation of Valve-in-Valve and Valve-in-Ring Implantation From the VIVID Registry. Circulation. Jan 12 2021; 143(2): 104-116.
  74. Sorajja P, Mack M, Vemulapalli S, et al. Initial experience with commercial transcatheter mitral valve repair in the United States. J Am Coll Cardiol. Mar 15 2016; 67(10):1129-1140.
  75. Sorajja P, Vemulapalli S, Feldman T, et al. Outcomes With transcatheter mitral valve repair in the United States: An STS/ACC TVT Registry Report. J Am Coll Cardiol. Nov 7 2017;70(19):2315-2327.
  76. Srinivasan A, Brown J, Ahmed H, et al. PASCAL repair system for patients with mitral regurgitation: A systematic review. Int J Cardiol. Apr 01 2023;376: 108-114.
  77. Stone GW, Abraham WT, Lindenfeld J, et al. Five-Year Follow-up after Transcatheter Repair of Secondary Mitral Regurgitation. N Engl J Med. Mar05 2023.
  78. Stone GG, Lindenfeld JJ, Abraham WW, et al. Transcatheter Mitral Valve repair in patients with heart failure. N. Engl. J. Med, 2018 Oct 4; 379 (24).
  79. Swaans MJ, Bakker AL, Alipour A, et al. Survival of transcatheter mitral valve repair compared with surgical and conservative treatment in high-surgical-risk patients. JACC Cardiovasc Interv. Aug 2014; 7(8):875-881.
  80. Szerlip M, Spargias KS, Makkar R, et al. 2-Year Outcomes for Transcatheter Repair in Patients With Mitral Regurgitation From the CLASP Study. JACCCardiovasc Interv. Jul 26 2021; 14(14): 1538-1548.
  81. Szlapka M, Hausmann H, Timm J, et al. Transcatheter mitral valve implantation versus conventional redo surgery for degenerated mitral valve prostheses and rings in a multicenter registry. J Thorac Cardiovasc Surg. Mar 2024; 167(3): 957-964.
  82. Takagi H, Ando T, Umemoto T. A review of comparative studies of MitraClip versus surgical repair for mitral regurgitation. Int J Cardiol. Feb 01 2017; 228:289-294.
  83. Takagi H, Hari Y, Kawai N, et al. Transcatheter mitral valve replacement for mitral regurgitation – A meta-analysis. J Card Surg. 2018 Dec;33(12):827-835.
  84. Taramasso M, Maisano F, Denti P, et al. Percutaneous edge-to-edge repair in high-risk and elderly patients with degenerative mitral regurgitation: midterm outcomes in a single-center experience. J Thorac Cardiovasc Surg. Dec 2014; 148(6):2743-2750.
  85. Urena M, Brochet E, Lecomte M, et al. Clinical and haemodynamic outcomes of balloon-expandable transcatheter mitral valve implantation: a 7-year experience. Eur Heart J. Jul 21 2018; 39(28): 2679-2689.
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POLICY HISTORY:

Medical Policy Panel, July 2014

Medical Policy Group, July 2014 (4): New Policy

Medical Policy Administration Committee,

Available for comment July 28 through September 8, 2014

Medical Policy Group, November 2014 (4): 2015 Coding update. Added new CPT codes 33418, 33419 and added previous coding to include 0343T and 0344T.

Medical Policy Panel, October 2015

Medical Policy Group, October 2015 (4): Updates to Description, Key Points, Approved Governing Bodies, and References. Added policy statement for transcatheter mitral valve repair with FDA approved device meets criteria for patients with symptomatic, degenerative mitral regurgitation who are considered a prohibitive risk for open surgery.

Available for comment October 23 through December 6, 2015

Medical Policy Panel, May 2016

Medical Policy Group, May 2016 (4): Updates to Key Points and References.  No change to policy statement.

Medical Policy Group, December 2016: 2017 Annual Coding Update.  Added 93590 and 93592 to Current Coding section.

Medical Policy Panel, May 2017

Medical Policy Group, June 2017 (4): Updates to Description, Key Points, and References.  No change to policy statement. Removed CPT codes 93590 and 93592.  Added in error to policy.

Medical Policy Panel, May 2018

Medical Policy Group, May 2018 (4): Updates to Description, Key Points, Coding, and References.  Removed 2 codes from Previous coding (0343T and 0344T) which were deleted 1/1/15. Nomenclature change noted to policy statement. Added “primary” (AKA degenerative) to policy statement.  Intent of statement unchanged.

Medical Policy Panel, May 2019

Medical Policy Group, June 2019 (4): Updates to Description, Policy, Key Points, and References. Removed policy statements that were effective for dates of service to October 31, 2015. Updated policy statement to allow coverage for transcatheter mitral valve repair for patients who are not operable candidates with HF, moderate to severe or severe symptomatic secondary MR despite maximally tolerated GDMT, and not eligible for surgical MVR judged by a cardiac surgeon.

Medical Policy Administrative Committee: June 2019

Available for Comment: June 13, 2019 through July 29, 2019

Medical Policy Group, June 2019: July 2019 quarterly coding update. Added new code 0543T to current coding.  New investigational statement added to policy for transapical approach.

Medical Policy Panel, May 2020

Medical Policy Group, June 2020 (4): Updates to Key Points and References.  No change to policy statements.

Medical Policy Panel, May 2021

Medical Policy Group, May 2021 (4): Updates to Key Points and References.  Policy statement updated to remove “not medically necessary,” no change to policy intent.

Medical Policy Panel, May 2022

Medical Policy Group, June 2022 (4): Updates to Policy section, Key Points, and References.  Added criteria points to secondary mitral regurgitation policy statement to include: LVEF between 20-50%, LVESD ≤ 70mm, and Pulmonary artery systolic pressure ≤ 70mmHg.

Medical Policy Administration Committee: May 2022

Available for draft: June 1, 2022 through July 16, 2022

Medical Policy Panel, May 2023

Medical Policy Group, May 2023 (4):  Updates to Policy Title, Policy Statement section, Description, Key Points, Key Words, Approved by Governing Bodies, Current Coding, and References.  Added IV statement for mitral valve replacement. Previously considered IV and added to this MP for clarity. Removed policy statements effective for dates of service on and after November 1, 2015 through June 12, 2019. Added Key Words mitral valve replacement and PASCAL.  Added CPT codes 0483T and 0484T.

Medical Policy Administration Committee, June 2023

Available for draft: June 1, 2023 through July 15, 2023

Medical Policy Panel, July 2024

Medical policy Group, July 2024 (4):  Updates to Policy, Description, Key Points, Approved by Governing Bodies and References. Updated MV replacement to medically necessary when certain criteria are met.

Medical Policy Administration Committee, July 2024

Available for draft: August 1, 2024 through September15, 2024

 

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

 

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

 

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.