Latest Review Date: February 2024

Category: Surgery                                                                 

POLICY:

Surgical ventricular restoration is considered investigational for the treatment of ischemic dilated cardiomyopathy.

DESCRIPTION OF PROCEDURE OR SERVICE:

Surgical ventricular restoration (SVR) is a procedure designed to restore or remodel the left ventricle to its normal, spherical shape and size in patients with akinetic segments of the heart, secondary to ischemic dilated cardiomyopathy.

The SVR procedure is usually performed after coronary artery bypass grafting (CABG) and may precede or be followed by mitral valve repair or replacement and other procedures such as endocardectomy and cryoablation for treatment of ventricular tachycardia.  A key difference between surgical ventricular restoration and ventriculectomy (i.e. for aneurysm removal) is that in SVR circular “purse string” suturing is used around the border of the aneurysmal scar tissue. Tightening of this suture is believed to isolate the akinetic or dyskinetic scar, bring the healthy portion of the ventricular walls together, and restore a more normal ventricular contour. If the defect is large (i.e., an opening >3cm), the ventricle may also be reconstructed using patches of autologous or artificial material to maintain the desired ventricular volume and contour during closure of the ventriculotomy. In addition, SVR is distinct from partial left ventriculectomy (i.e., the Batista procedure), which does not attempt to specifically resect akinetic segments and restore ventricular contour.

SVR may also be referred to as surgical anterior ventricular endocardial restoration (SAVER), left ventricular reconstructive surgery, endoventricular circular plasty, or the Dor procedure after Vincent Dor, M.D.  Dr. Dor pioneered expansion of techniques for ventricular reconstruction and is credited with treating congestive heart failure patients with SVR in conjunction with CABG.

KEY POINTS:

The most recent literature search was performed through January 8, 2024.

Summary

For individuals who have ischemic dilated cardiomyopathy who receive SVR as an adjunct to CABG, the evidence includes a single large randomized controlled trial (RCT) (another RCT reported results, but most of the patients overlapped with those in the larger trial) and uncontrolled studies. Relevant outcomes are survival, quality of life (QOL), hospitalizations, resource utilization, and treatment related morbidity. The RCT, the Surgical Treatment of Ischemic Heart Failure (STICH) trial, did not report significant improvements in QOL outcomes for patients undergoing SVR as an adjunct to standard CABG surgery. Several uncontrolled studies have suggested that SVR can improve the hemodynamic functioning in selected patients with ischemic cardiomyopathy; however, these studies are considered lower quality evidence. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

American Association for Thoracic Surgery

The American Association for Thoracic Surgery published an expert consensus document on coronary artery bypass grafting (CABG) in patients with ischemic cardiomyopathy and heart failure in 2021. The document notes that tenets of surgical ventricular restoration (SVR) at the time of CABG that may "confer the most benefit to patients include resection of scarred myocardium, reducing ventricular size, and restoring an anatomically elliptical shape"; however, the document notes that "it remains uncertain which patients should receive [SVR] as part of the CABG operation and what the impact is on long-term survival and functional outcome." The American Association for Thoracic Surgery does state that "concomitant SVR should be considered for patients with a true left ventricular aneurysm" (class of recommendation: IIa; level of evidence: B-R).

U.S. Preventive Services Task Force Recommendations

Surgical ventricular restoration is not a preventive service.

KEY WORDS:

DOR procedure, surgical anterior endocardial restoration (SAVER), surgical ventricular restoration (SVR), ventricular restoration or remodeling, CorRestore™

APPROVED BY GOVERNING BODIES

The U.S. Food and Drug Administration regulates the marketing of devices used as intracardiac patches through the 510(k) clearance process. These devices are Class II and are identified as polypropylene, polyethylene terephthalate, or polytetrafluoroethylene patch or pledget placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures. Biological tissue may also be a component of the patches. 

In 2004, the CorRestore™ Patch System (Somanetics; acquired by Medtroinc) is a device cleared by the U.S. Food and Drug Administration through the 510(k) process that is specifically labeled for use “as an intracardiac patch for cardiac reconstruction and repair.” The device consists of an oval tissue patch made from glutaraldehyde-fixed bovine pericardium. It is identical to other marketed bovine pericardial patches except that it incorporates an integral suture bolster in the shape of a ring that is used along with ventricular sizing devices to restore the normal ventricular contour. Product code: DXZ.

In 2020, Ancora Heart announced that it received an FDA investigational device exemption for its AccuCinch® ventricular restoration system. This exemption allows Ancora Heart to proceed with an initial efficacy and safety study in patients with heart failure and reduced ejection fraction.

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

CURRENT CODING:

CPT Codes:

REFERENCES:

1. Athanasuleas CL, Stanley AW, Buckberg GD, et al. Surgical anterior ventricular endocardial restoration (SAVER) for dilated ischemic cardiomyopathy. Semin Thorac Cardiovasc Surg, October 2001; 13(4): 448-58.
2. Athanasuleas CL, Stanley AW Jr, Buckberg GD, et al. Surgical anterior ventricular endocardial restoration (SAVER) in the dilated remodeled ventricle after anterior myocardial infarction. RESTORE group.  Reconstructive Endoventricular Surgery, returning torsion original radius elliptical shape to the LV, J Am Coll Cardiol, April 2001; 37(5): 1199-209.
3. Bakaeen FG, Gaudino M, Whitman G, et al. 2021: The American Association for Thoracic Surgery Expert Consensus Document: Coronary artery bypass grafting in patients with ischemic cardiomyopathy and heart failure. J Thorac Cardiovasc Surg. Sep 2021; 162(3): 829-850.e1.
4. Bolooki H, DeMarchena E, Mallon SM, et al. Factors affecting late survival after surgical remodeling of left ventricular aneurysms. J Thorac Cardiovasc Surg, August 2003; 126(2): 374-83.
5. Dor V, Di Donato M, Sabatier M, et al. Left ventricular reconstruction by endoventricular circular patch plasty repair: a 17-year experience. Semin Thorac Cardiovasc Surg, October 2001; 13(4): 435-47.
6. Dzemali O, Risteski P, Bakhtiary F et al. Surgical left ventricular remodeling leads to better long-term survival and exercise tolerance than coronary artery bypass grafting alone in patients with moderate ischemic cardiomyopathy. J Thorac Cardiovasc Surg 2009; 138(3):663-8.
7. Hernandez AF, Velazquez EJ, Dullum MK, et al. Contemporary performance of surgical ventricular restoration procedures: data from the Society of Thoracic Surgeons’ National Cardiac Database. Am Heart Journal 2006; 152(3): 494-499.
8. Holly TA, Bonow RO, Arnold JM, et al. Myocardial viability and impact of surgical ventricular reconstruction on outcomes of patients with severe left ventricular dysfunction undergoing coronary artery bypass surgery: results of the Surgical Treatment for Ischemic Heart Failure trial. J Thorac Cardiovasc Surg. Dec 2014; 148(6):2677-2684 e2671.
9. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
10. Jones RH, Velazquez EJ, Michler RE, et al. Coronary bypass surgery with or without surgical ventricular reconstruction. N Engl J Med. Apr 23 2009; 360(17):1705-1717.
11. Kukulski T, She L, Racine N, et al. Implication of right ventricular dysfunction on long-term outcome in patients with ischemic cardiomyopathy undergoing coronary artery bypass grafting with or without surgical ventricular reconstruction. J Thorac Cardiovasc Surg. May 2015; 149(5):1312-1321.
12. Marchenko A, Chernyavsky A, Efendiev V et al. Results of coronary artery bypass grafting alone and combined with surgical ventricular reconstruction for ischemic heart failure. Interact Cardiovasc Thorac Surg 2011; 13(1):46-51.
13. Mark DB, Knight JD, Velazquez EJ et al. Quality of life and economic outcomes with surgical ventricular reconstruction in ischemic heart failure: results from the Surgical Treatment for Ischemic Heart Failure trial. Am Heart J 2009; 157(5):837-44, 844 e831-33.
14. Michler RE, Rouleau JL, Al-Khalidi HR et al. Insights from the STICH trial: change in left ventricular size after coronary artery bypass grafting with and without surgical ventricular reconstruction. J Thorac Cardiovasc Surg 2012.
15. Mickleborough LL, Merchant N, Ivanov J, et al. Left ventricular reconstruction: Early and late results. J Thorac Cardiovasc Surg, July 2004; 128(1): 27-37.
16. Neumann FJ, Sousa-Uva M, Ahlsson A, et al. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. Jan 7 2019;40(2):87-165.
17. Oh JK, Velazquez EJ, Menicanti L et al. Influence of baseline left ventricular function on the clinical outcome of surgical ventricular reconstruction in patients with ischaemic cardiomyopathy. Eur Heart J 2013; 34(1):39-47.
18. Ohira S, Yamazaki S, Numata S, et al. Ten-year experience of endocardial linear infarct exclusion technique for ischaemic cardiomyopathy. Eur J Cardiothorac Surg. Sep 25 2017.
19. Pina IL, Zheng Q, She L, et al. Sex Difference in Patients With Ischemic Heart Failure Undergoing Surgical Revascularization:Results From the STICH Trial (Surgical Treatment for Ischemic Heart Failure). Circulation. Feb 20 2018; 137(8): 771-780.
20. Prior DL, Stevens SR, Holly TA, et al. Regional left ventricular function does not predict survival in ischaemic cardiomyopathy after cardiac surgery. Heart. Sep 2017; 103(17):1359-1367.
21. Ribeiro GA, da Costa CE, Lopes MM, et al. Left ventricular reconstruction benefits patients with ischemic cardiomyopathy and non-viable myocardium. Eur J Cardiothorac Surg 2006; 29(2): 196-201.
22. Sartipy U, Albage A, Lindblom D. The Dor Procedure for left ventricular reconstruction. Ten year clinical experience. Eur J Cardio-thoracic Surg 2005; 27: 1005-1010.
23. Task Force on Myocardial Revascularization of the European Society of C, the European Association for Cardio-Thoracic S, European Association for Percutaneous Cardiovascular I, et al. Guidelines on myocardial revascularization. Eur Heart J. Oct 2010; 31(20):2501-2555.
24. Tulner SA, Bax JJ, Bleeker GB, et al. Beneficial hemodynamic and clinical effects of surgical ventricular restoration in patients with ischemic dilated cardiomyopathy. Ann Thorac Surg 2006; 82(5): 1721-1727.
25. Tulner SA, Steendijk P, Klautz RJ, et al. Clinical efficacy of surgical heart failure therapy by ventricular restoration and restrictive mitral annuloplasty. J Card Fail, April 2007; 13(3): 178-183.
26. Williams JA, Weiss ES, Patel ND, et al. Outcomes following surgical ventricular restoration for patients with clinically advanced congestive heart failure (New York Heart Association Class IV). J Card Fail, August 2007; 13(6): 431-436.
27. Wijns W, Kolh P, Danchin N et al. Guidelines on myocardial revascularization. Eur Heart J 2010; 31(20):2501-55.
28. Windecker S, Kolh P, Alfonso F, et al. 2014 ESC/EACTS Guidelines on Myocardial Revascularization, European Heart Journal (2014) 35, 2541-2619. //eurheartj.oxfordjournals.org/content/ehj/35/37/2541.full.pdf.
29. Yang T, Yuan X, Li B, et al. Long-term outcomes after coronary artery bypass graft with or without surgical ventricular reconstruction in patients with severe left ventricular dysfunction. J Thorac Dis. Apr 28 2023; 15(4): 1627-1639.

POLICY HISTORY:

Medical Policy Group, October 2005 (3)
Medical Policy Administration Committee, October 2005
Medical Policy Group, October 2007 (1)
Medical Policy Group, October 2009 (1)
Medical Policy Group, August 2011 (1): Update to Description, Key Points and References, no change in policy statement
Medical Policy Group, August 2012 (4): Updated Key Points and References. No change in policy statement.
Medical Policy Group August 2013 (4): Updated Key Points and Reference. No changes to the policy statement.
Medical Policy Panel, August 2014
Medical Policy Panel, August 2014 (3):  2014 Updates – no additional information/literature available for review; no changes to policy statement
Medical Policy Panel, August 2015
Medical Policy Group, August 2015 (4): Updates to Key Points, Key Words, and References. No policy statement change.
Medical Policy Panel, February 2016
Medical Policy Group, February 2016 (4): Updates to Key Points.  No change to policy statement.
Medical Policy Panel, February 2017
Medical Policy Group, March 2017 (4): Updates to Key Points.  Removed “or postinfarction left ventricular aneurysm” from the policy statement. No change to intent of policy.
Medical Policy Panel, February 2018
Medical Policy Group, February 2018 (4): Updates to Key Points and References. No change to policy statement.
Medical Policy Panel, February 2019
Medical Policy Group, March 2019 (4): Updates to Key Points, Approve by Governing Bodies, and References.  No change in policy statement.
Medical Policy Panel, February 2020
Medical Policy Group, February 2020 (4): Updates to Description.  No change in policy statement.
Medical Policy Panel, February 2021
Medical Policy Group, February 2021 (4): Updates to Key Points, Approved by Governing Bodies, and References.  No change to policy statement.

Medical Policy Panel, February 2022

Medical Policy Group, February 2022 (4): Updates to Key Points and References. No change to policy statement.  Removed the following references: Di Donato M, Toso A, Maioli M, et al. Intermediate survival and predictors of death after surgical ventricular restoration. Semin Thorac Cardiovasc Surg, October 2001; 13(4): 468-75; Di Donato M, Sabatier M, Dor V; RESTORE Group. Surgical ventricular restoration in patients with postinfarction coronary artery disease: Effectiveness on spontaneous and inducible ventricular tachycardia. Semin Thorac Cardiovasc Surg, October 2001; 13(4): 480-5; Menicanti L, Di Donato M, Frigiola A, et al.  Ischemic mitral regurgitation: Intraventricular papillary muscle imbrication without mitral ring during left ventricular restoration. J Thorac Cardiovasc Surg, June 2002; 123(6): 1041-50; Menicanti L, Di Donato M; RESTORE Group. Surgical ventricular reconstruction and mitral regurgitation: What have we learned from 10 years of experience? Semin Thorac Cardiobasc Surg, October 2001; 13(4): 496-503.

Medical Policy Panel, February 2023

Medical Policy Group, February 2023 (4): Updates to Key Points and Benefil Application.  No change to policy statement.

Medical Policy Panel, February 2024

Medical Policy Group, February 2024 (4): Updates to Key Points and References.  No change to policy statement.

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.