Medical policy: Surgical Ventricular Restoration

Policy number: MP 1.082

Effective date: 4/1/2026

Policy

Surgical ventricular restoration

Surgical ventricular restoration is considered investigational for the treatment of ischemic dilated cardiomyopathy as there is insufficient evidence to support a conclusion concerning the health outcomes or benefits associated with this procedure.

Policy guidelines

Surgical ventricular restoration involves increased physician work compared with standard ventriculectomy. For example, the procedure includes evaluation of the ventricular septum and reshaping of the geometry of the heart. Surgical ventricular restoration is described as a global treatment of left ventricular failure, while conventional left ventricular aneurysmectomy represents a local treatment of a transmural infarct.

Cross-references

• MP 1.026 Total Artificial Hearts and Implantable Ventricular Assist Devices

Product variations

This policy is only applicable to certain programs and products administered by Capital Blue Cross and subject to benefit variations. Please see additional information below.

FEP PPO - Refer to FEP Medical Policy Manual.

Description/background

Surgical ventricular restoration

Surgical ventricular restoration is 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.

Surgical ventricular restoration (SVR) is also known as surgical anterior ventricular endocardial restoration, left ventricular reconstructive surgery, endoventricular circular plasty, or the Dor procedure. Named after the surgeon who pioneered the expansion of techniques for ventricular reconstruction and is credited with treating heart failure patients with SVR and coronary artery bypass grafting.

Surgical ventricular restoration is usually performed after coronary artery bypass grafting 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 SVR 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 >3 cm), the method may also reconstruct using patches of autologous or artificial material to minimize 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 specifically to resect akinetic segments and restore ventricular contour.

Regulatory status

The U.S. Food and Drug Administration (FDA) 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 (Somamedics; acquired by Medtronic) was cleared for marketing by the FDA 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 circular suturing devices to restore normal ventricular contour. FDA 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. In 2022, the FDA granted Breakthrough Device Designation to the AccuCinch® ventricular restoration system.

Rationale

Summary of evidence

For individuals who have ischemic dilated cardiomyopathy who receive SVR as an adjunct to coronary artery bypass grafting, the evidence includes a large randomized controlled trial (RCT) (another RCT reported results, but most trial enrollees overlapped with those in the larger trial) and uncontrolled studies. Relevant outcomes are overall survival, symptoms, quality of life, hospitalizations, resource utilization, and treatment‑related morbidity. The RCT, the Surgical Treatment of Ischemic Heart Failure trial, did not report significant improvements in quality‑of‑ life outcomes for patients undergoing SVR as an adjunct to standard coronary artery bypass graft surgery. Several uncontrolled studies have suggested that SVR can improve 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 outcomes.

Definitions

Cardiomyopathy is a disease of the myocardium (heart muscle) causing enlargement.

Heart failure is an abnormal condition that reflects impaired cardiac pumping. It causes increased myocardial infarction, ischemic heart disease, and cardiomyopathy. Failure of the ventricles to eject blood efficiently results in volume overload, ventricular dilation, and elevated intracardiac pressure.

Electrostimulation refers to the use of electric current to affect a tissue, such as a nerve, muscle, or bone.

Disclaimer

Capital Blue Cross’ medical policies are used to determine coverage for specific medical technologies, procedures, equipment, and services. These medical policies do not constitute medical advice and are subject to change as permitted by law or applicable clinical evidence from independent treatment guidelines. Treating providers are solely responsible for medical advice and treatment of members. These policies are not a guarantee of coverage or payment. Payment of claims is subject to a determination regarding the member’s benefit program and eligibility on the date of service, and a determination that the services are medically necessary and appropriate. Final processing of a claim is based upon the terms of contract that applies to the member’s benefit program, including benefit limitations and exclusions. If a provider or a member has a question concerning this medical policy, please contact Capital Blue Cross’ Provider Services or Member Services.

Coding information

Note: This list of codes may not be all‑inclusive, and codes are subject to change at any time. The identification of a code in this section does not denote coverage as coverage is determined by the terms of member benefit information. In addition, not all covered services are eligible for separate reimbursement.

Investigational; therefore, not covered

References

1. 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): 1705-17. PMID 19329820
2. 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): 2677-84.e1. PMID 25152476
3. 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 ischemic cardiomyopathy. Eur Heart J. Jan 2013; 34(1): 39-47. PMID 22584648
4. 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. Nov 2013; 146(5): 1139-1145.e6. PMID 23111018
5. 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): 1312-21. PMID 25451487
6. Pirrò JL, Stevens SR, Holly TA, et al. Regional left ventricular function does not predict survival in ischemic cardiomyopathy after cardiac surgery. Heart. Sep 2017; 103(17): 1359-1367. PMID 28446548
7. Pirrò JL, 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. PMID 29459462
8. 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. May 2009; 157(5): 837-44, 844.e1-3. PMID 19376309
9. Marchenko A, Chernyshev A, Efendiev E, et al. Results of coronary artery bypass grafting alone and combined with surgical ventricular reconstruction for ischemic heart failure. Interact Cardiovasc Thorac Surg. Jul 2011; 13(1): 46-51. PMID 20426000
10. Athanasiadis CL, Stanley AW, 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. Apr 2001; 37(5): 1199-203. PMID 11300423
11. Mickleborough LL, Merchant M, Ivanov J, et al. Left ventricular reconstruction: Early and late results. J Thorac Cardiovasc Surg. Jul 2004; 128(1): 27-37. PMID 15224018
12. Bolooki H, DeMarchena E, Fallon SM, et al. Factors affecting late survival after surgical remodeling of left ventricular aneurysms. J Thorac Cardiovasc Surg. Aug 2003; 126(2): 374-83; discussion 383-5. PMID 12928633
13. Sartipy U, Dahlgren E. The Dor procedure for left ventricular reconstruction. Ten-year experience. Eur J Cardio Thorac Surg. Jun 2005; 27(6): 1005-10. PMID 15896609
14. 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 J. Sep 2006; 152(3): 494-e9. PMID 16923420
15. 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. PMID 37197557
16. Hamid N, Horde UP, Reisman M, et al. Transcatheter Left Ventricular Restoration in Patients With Heart Failure. J Card Fail. Jul 2023; 29(7): 1046-1055. PMID 36958391
17. 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. Nov 2006; 82(5): 1721-7. PMID 17062236
18. 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. Apr 2007; 13(3): 178-83. PMID 17448414
19. Williams JA, Weiss ES, Patel ND, et al. Outcomes following surgical ventricular restoration in patients with clinically advanced congestive heart failure (New York Heart Association Class IV). J Card Fail. Aug 2007; 13(6): 431-6. PMID 17675056
20. Dzemaili 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. Sep 2009; 138(3): 663-8. PMID 19698853
21. Ohira S, Yamazaki S, Numata S, et al. Ten-year experience of endocardial linear infarct exclusion technique for ischemic cardiomyopathy. Eur J Cardiothorac Surg. Feb 01 2018; 53(2): 440-447. PMID 29029034
22. Bakaeem EG, Gaudin D, Whitman GJ, et al. 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. PMID 34272070