Surgical Ventricular Restoration

POLICY NUMBER

A.7.01.103

DESCRIPTION

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

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 (ie, an opening >3 cm), 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 (ie, the Batista procedure), which does not attempt specifically to resect akinetic segments and restore ventricular contour.

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 Medtronic) was cleared for marketing by the U.S. Food and Drug Administration 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.

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.

POLICY

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

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

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.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

7/11/2008: Policy added.

11/20/2008: Approved by Medical Policy Advisory Committee (MPAC).

04/23/2010: Policy description and statement unchanged. FEP verbiage added to the Policy Exceptions section.

09/28/2011: Policy reviewed; no changes.

09/27/2012: Policy reviewed; no changes.

10/22/2013: Policy reviewed; no changes.

10/08/2014: Policy reviewed; description updated. Policy statement unchanged. Policy guidelines updated.

08/27/2015: Code Reference section updated to add ICD-10 codes.

10/22/2015: Policy description updated. Policy statement unchanged. Investigative definition updated in policy guidelines section.

03/31/2016: Policy description updated. Policy statements unchanged.

05/31/2016: Policy number A.7.01.103 added.

02/27/2017: Policy section updated to remove "or post-infarction left ventricular aneurysm" from the policy statement. It previously stated: Surgical ventricular restoration is considered investigational for the treatment of ischemic dilated cardiomyopathy or post-infarction left ventricular aneurysm.

03/07/2018: Policy description updated. Policy statement unchanged.

01/30/2019: Code Reference section updated to add ICD-10 procedure codes 02RK0JZ and 02UK0JZ.

03/20/2019: Policy description updated regarding devices. Policy statement unchanged.

03/11/2020: Policy description updated. Policy statement unchanged.

05/20/2021: Policy description updated regarding devices. Policy statement unchanged.

06/18/2021: Code Reference section updated to add new CPT code 0643T, effective 07/01/2021.

04/11/2022: Policy reviewed; no changes.

03/20/2023: Policy description updated. Policy statement unchanged.

03/20/2024: Policy reviewed; no changes.

04/10/2025: Policy description updated regarding devices. Policy statement unchanged.

SOURCE(S)

Blue Cross & Blue Shield Policy # 7.01.103

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Investigational Codes

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