BlueCross and BlueShield of Montana Medical Policy/Codes
Percutaneous Endovascular Mitral Valve Repair
Chapter: Surgery: Procedures
Current Effective Date: October 25, 2013
Original Effective Date: October 25, 2013
Publish Date: July 25, 2013
Description

The mitral or bicuspid valve is the two-leafed valve between the left atrium and left ventricle of the heart. This valve closes the opening between the left atrium and left ventricle when the ventricle contracts to pump blood through the aorta to the body. Mitral regurgitation (MR) is backflow of blood from the left ventricle to the left atrium due to failure of the valve to close completely. MR is a fairly common abnormality, with some degree of physiologic mitral insufficiency seen in up to 80% of the adult population. Although usually well-tolerated if mild, higher grades of MR can result in significant decrease in cardiac function and increase in patient symptoms. MR is progressive, generally increasing in prevalence and severity with age, and can result in left ventricular failure, arrhythmias, and pulmonary hypertension. As disability progresses or cardiomegaly increases, surgical correction may be indicated. Valve repair can involve a prosthetic ring that reduces the size of the annulus, or tethered leaflets that correct the incompetence by immobilization. When the valve cannot be repaired, valve replacement may be performed. Currently, mitral valve repair requires an open-heart surgical procedure with cardiopulmonary bypass, hospital stay of three to five days, and extended recovery period at home.

Several companies are developing products that allow for percutaneous mitral valve treatment. Evalve, Inc. has developed catheter-based technology in which the cardiologist guides a percutaneous catheter to the mitral valve using a venous access and a transseptal approach. The Evalve MitraClip™ is introduced through the catheter and is placed on the center of the valve leaflets clipping them together. Alignment and residual MR is assessed using fluoroscopy and echocardiography. This approach is based on an open-heart surgical method known as edge-to-edge repair (Alfieri technique) in which the surgeon sutures the valve leaflets together to reduce regurgitation. Human trials are currently underway to evaluate the safety and efficacy of this procedure; at this time the U.S. Food and Drug Administration (FDA) limits this device to investigational use only. Placement of a self-compressing ring device in the coronary sinus along the region of the posterior mitral annulus (annuloplasty) is another type of percutaneous approach that has reduced MR in canine models.

In the Evalve trials, the procedure is performed under general anesthesia, and involves return home within 48 hours, no surgical wound, and very little recovery/rehabilitation period at home.

Policy

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Investigational

Blue Cross and Blue Shield of Montana (BCBSMT) considers percutaneous endovascular mitral valve repair using leaflet clips and/or annuloplasty experimental, investigational and unproven for treatment of mitral valve regurgitation (insufficiency).

Rationale

Although MR effects can be reduced by pharmacological interventions, MR requires surgical intervention for definitive treatment. Generally, once the left ventricle has begun to dilate and/or fail (left ventricular end systolic diameter >45 mm and/or ejection fraction <60%), valve repair or replacement should be considered, whether or not the patient is symptomatic. Data collected in a regional study between January 1990 and December 1999 (4) demonstrated a substantial increase in mitral valve repair and replacement procedures, including a significantly increased number of octogenarians and patients with ejection fraction <40%. Studies show that mitral valve repair is associated with better survival rate but an increased rate of repeat operation compared to mitral valve replacement. Currently, surgical treatment of MR requires circulatory arrest and cardiopulmonary bypass. Because of risks and possible complications, avoiding cardiopulmonary bypass has significant advantages, especially in the presence of left ventricle dysfunction and associated pulmonary hypertension. The expectation for percutaneous endovascular mitral valve repair is that patients will benefit from reduced risk and shorter recovery periods, and possibly avoid or delay the need for an open-heart procedure.

  • A study reported in October, 2003 that was performed on adult pigs demonstrated that the endovascular approach was successful for the edge-to-edge repair technique. (10)
  • Another successful study on adult pigs was reported in March 2007. (21)
  • Currently, percutaneous endovascular mitral valve repair with the Evalve MitraClip™ on humans is in Phase II clinical trials, under FDA Investigational Device Exemption (IDE) approval, with expected completion date of September 2008. (24)

Currently there are no published data to show increased net health outcomes, efficacy, safety, or positive results attainable outside the investigational setting for either the Evalve MitraClip™ or the annuloplasty procedures, and no conclusions can be drawn outside the research arena. Therefore, neither the procedure nor the technology is supported by evidence in peer-reviewed medical literature that demonstrates an improvement of health outcomes, or that demonstrates percutaneous endovascular mitral valve repair is as beneficial as established alternatives, or that demonstrates benefits are attainable outside investigational settings.

2009 Update

Clinical trials sponsored by Evalve are still ongoing: NCT00209339, NCT00209274. A search of peer reviewed literature through August 2009 identified no new clinical trial publications or any additional information that would change the coverage position of this medical policy.

2011 Update

Four clinical trials were located in the ClinicalTrials.gov database; these studies are still in progress.

  • Feasibility Study of a Percutaneous Mitral Valve Repair System. (EVEREST[I]) [NCT00209339; sponsored by Evalve, Inc.; ongoing, but not recruiting participants] (31);
  • Pivotal Study of a Percutaneous Mitral Valve Repair System (EVEREST II) [NCT00209274; sponsored by Evalve, Inc.; currently recruiting participants] (27);
  • ACCESS-Europe A Two-Phase Observational Study of the MitraClip® System in Europe (ACCESS-EU) [NCT01288976; sponsored by Evalve, Inc.; currently recruiting participants] (28);
  • MitraClip System in Australia and New Zealand (MitraClipANZ) [NCT01301625; sponsored by Evalve, Inc.; not yet open for participant recruitment]. (29)

In 2010, Tamburino et al. (26) reported that, although the field of percutaneous management of MR is at an early stage, it has been demonstrated to reduce MR, suggesting there is a good potential for clinical benefit to patients with MR. A search of peer reviewed literature through March 2011 identified no new clinical trial publications or any additional information that would change the coverage position of this medical policy.

2013 Update

The EVEREST Phase I Clinical Trial has been published (NCT00209339); 27 patients had 6-month follow up. This trial showed that percutaneous edge-to-edge mitral valve repair can be performed safely and a reduction in MR can be achieved in a significant proportion of patients to 6 months. Patients who required subsequent surgery had elective mitral valve repair or intended replacement. (31) In 2012, Glower et al. reported The EVEREST Phase II Trial (NCT00209274) is ongoing and currently recruiting participants. The EVEREST II Trial is a prospective, multicenter, randomized controlled trial comparing percutaneous repair with the MitraClip device to mitral valve (MV) surgery in the treatment of MR. The study analyzed the patient characteristics and treatment effects on mitral repair versus replacement. Of 279 patients enrolled, 80 surgical patients underwent 82 MV operations and 178 underwent an initial MitraClip procedure, of whom 37 underwent a subsequent MV operation within 1 year of their index the MitraClip procedure. A logistic regression model was used to predict MV replacement according to valve pathology, etiology of mitral regurgitation, age, previous cardiac surgery, and treatment group. The rate of percutaneous or surgical MV repair at 1 year was 89% (158/178) in patients initially receiving the MitraClip device versus 84% (67/80) in the surgical patients (P = .36). Surgical repair was performed after the MitraClip procedure in 20 (54%) of 37 patients (P < .001 vs surgery). In both the MitraClip device and surgery groups, MV replacement was significantly associated with anterior leaflet pathology (P = .035). Logistic regression analysis showed that anterior leaflet pathology predicted MV replacement. In 5 (13.5%) of 37 patients undergoing surgery after MitraClip therapy, replacement was performed in part because of MV injury associated with the MitraClip procedure. The study concluded that the data suggest that anterior leaflet pathology is strongly associated with MV replacement in patients undergoing either de novo MV surgery or surgery after MitraClip therapy. MitraClip therapy has a repair rate similar to surgery through 1 year but also imparts a risk of replacement of a potentially repairable valve.

A search of peer reviewed literature through February 2013 identified no new clinical trial publications or any additional information that would change the coverage position of this medical policy.

Coding

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. 

ICD-9 Codes

35.96, 35.97, 35.99, 394.1, 394.2, 394.9, 396.1, 396.2, 396.3, 396.8, 396.9, 424.0, 746.6, 746.7

ICD-10 Codes

I05.1, I05.2, I05.8, I05.9, I08.0, I08.8, I08.9, I34.0, I34.1, I34.9, Q23.3, Q23.4, 027G4ZZ, 027G4DZ, 02UG3JZ

Procedural Codes: 33999, 93799
References
  1. Acar, J., Michel, P.L., et.al. When is Surgery Needed for Minimally Symptomatic or Asymptomatic Acquired Valvulopathy?  Presse Medicale (2000 November 13) 29(34):1867-75.
  2. Mohty, D., Orszulak, T.A., et.al. Very Long-Term Survival and Durability of Mitral Valve Repair for Mitral Valve Prolapse. Circulation (2001 September 18) 104(12 Suppl 1):I1-17.
  3. Block, P.C., Percutaneous Mitral Valve Repair for Mitral Regurgitation. Journal of Interventional Cardiology (2003 February) 16(1):93-6.
  4. Nowicki, E.R., Weintraub, R.W., et.al. Mitral Valve Repair and Replacement. American Heart Journal (2003 June) 145(6):1058-62.
  5. Timek, T.A., Nielsen, S.L., et.al. Edge-To-Edge Mitral Valve Repair without Ring Annuloplasty for Acute Ischemic Mitral Regurgitation. Circulation (2003 September 9 ) 108 Supplement 1:II122-7.
  6. Moss, R.R., Humphries, K.H., et.al. Outcome of Mitral Valve Repair or Replacement: A Comparison by Propensity Score Analysis. Circulation (2003 September 9) 108 Supplement 1:II90-7.
  7. Clip Device Accomplished Endovascular, Non-Surgical Repair of Faulty Heart Valve. Press Release. Evanston, IL (2003 September 15)  http://www.evalveinc.com (Accessed 2004).
  8. New Endovascular Procedure May Spare Patients Suffering from Mitral Valve Regurgitation the Ordeal of Open-Heart Surgery. Press Release. Philadelphia, PA. (2003 September 15)  http://www.evalveinc.com (Accessed 2004).
  9. Emory Cardiologist Successfully Performs World’s Fifth Non-Surgical Repair of Faulty Heart Valve Press Release. Altanta, GA. (2003 October 17) http://www.whsc.emory.edu (Accessed 2004).
  10. St Goar, F.G., Fann, J.I., et.al. Endovascular Edge-To-Edge Mitral Valve Repair: Short Term Results in a Porcine Model. Circulation (2003 October 21) 108(16):1990-3.
  11. Dieter, Robert S. Percutaneous Valve Repair: Update on Mitral Regurgitation and Endovascular Approaches to the Mitral Valve. Applications in Imaging-Cardiac Interventions. (2003 October) pg.11-14. http://www.scai.org (Accessed 2004).
  12. Liddicoat, J.R., MacNeill, B.D., et.al. Percutaneous Mitral Valve Repair: A Feasibility Study in an Ovine Model of Acute Ischemic Mitral Regurgitation. Catheter Cardiovascular Intervention (2003 November) 60(3):410-6.
  13. Condado, J.A., and M. Velez-Gimon. Catheter-Based Approach to Mitral Regurgitation. Journal of Interventional Cardiology (2003 December) 16(6):523-34.
  14. Clip Device Accomplished Endovascular, Non-Surgical Repair of Faulty Heart Valve. Press Release. Evanston, IL (2004 March 9) http://www.evalveinc.com (Accessed 2004).
  15. Mehra, M.R., Gheorghiade, M., et.al. Mitral Regurgitation in Chronic Heart Failure: More Questions Than Answers?  Current Cardiology Reports (2004 March) 6(2):96-9.
  16. First NYC Patient Receives New Alternative to Open Heart Surgery for Mitral Valve Regurgitation at New York-Presbyterian/Columbia-Evalve Cardiovascular Repair System Currently Being Evaluated in Phase I Trial. Press Release. New York, NY (2004 May 3) http://www.columbiasurgery.org (Accessed 2004).
  17. Guidant Makes Equity Investment in Heart Valve Repair Company-Evalve, Inc.’s Innovative Technology Designed to Offer New Testament Option for Debilitating Condition. Press Release (2004 May 24) http://www.guidant.com (Accessed 2004).
  18. Evalve, Inc. Announces Completion of a $35 Million Series C Financing. Press Release (2004 May 24) http://www.delphiventures.com (Accessed 2004).
  19. Heart Surgery without the Surgeon: Columbia University Researchers Test New Cardiovascular Repair System for Mitral Valve Regurgitation. Press Release. New York, NY (2004 July 2) http://www.columbiasurgery.org (Accessed 2004).
  20. Kerani, A.R., Cheema, F.H., et.al. Edge-To-Edge Mitral Valve Repair: The Columbia Presbyterian Experience. Annals of Thoracic Surgery (2004 July) 78(1):73-6.
  21. Herrmann, H.C., Rohatqi, S., et al. Mitral valve hemodynamics effects of percutaneous edge-to-edge repair with the MitralClip device for mitral regurgitation. Catheterization and Cardiovascular Intervention (2006 December) 68(6):821-8.
  22. Naqvi, T.Z., Buchbinder, M., et al. Beating-heart percutaneous mitral valcve repair using a transcatheter endovascular suturing devide in an animal model. Catheter Cardiovascular Intervention (2007 March 1) 69(4):525-31.
  23. Chatterjee, A., de Leon, A., 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. Circulation 2008;118;e523-e661; originally published online (2008 September 26).
  24. Pivotal Study of a Percutaneous Mitral Valve Repair System. ClinicalTrials.gov. Accessed 5/11/2007 http://www.clinicaltrials.gov . Accessed 9/16/2009: Verified by Evalve June 2009.
  25. Feldman, T., Kar, S., et al. Percutaneous mitral repair with the MitraClip system: safety and midterm durability in the initial EVEREST (Endovascular Valve Edge-to-edge REpair STudy) cohort. J Am Coll Cardiol. 2009 Aug 18;54(8):686-94.
  26. Tamburino, C., ImmÃ, S., et al. Reduction of mitral valve regurgitation with MitraClipî pecutaneous system. Minerva Cardioangiol (2010 October) 58(5):589-98.
  27. Pivotal study of a percutaneous mitral valve repair system (EVEREST II). NCT00209274. Available at www.ClinicalTrials.gov (accessed February 2013).
  28. ACCESS-Europe A two-phase observational study of the MitraClip system in Europe (ACCESS-EU). NCT01288976. Available at www.ClinicalTrials.gov (accessed February 2013).
  29. MitraClip System in Australia and New Zealand (MitraClipANZ). NCT01301625. Available at www.ClinicalTrials.gov (accessed February 2013).
  30. Feldman T, Wasserman HS, 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 December 6; 46(11):2134-2140. Epub October 19, 2005.
  31. Glower D, Ailawadi G, et al. EVEREST II randomized clinical trial: predictors of mitral valve replacement in de novo surgery or after the MitraClip procedure. J Thorac Cardiovasc Surg. 2012 April; 143(4 Suppl):S60-3.
History
July 2013  New 2013 BCBSMT medical policy.  Percutaneous endovascular mitral valve repair using leaflet clips and/or annuloplasty is considered experimental, investigational and unproven for treatment of mitral valve regurgitation (insufficiency).
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Percutaneous Endovascular Mitral Valve Repair