Medical Policy



Subject: Transmyocardial/Perventricular Device Closure of Ventricular Septal Defects
Document #: SURG.00123 Current Effective Date:    03/29/2017
Status: Reviewed Last Review Date:    02/02/2017

Description/Scope

This document addresses the transmyocardial/perventricular device closure of ventricular septal defects (VSDs). Transmyocardial/perventricular device closure of a VSD approaches the defect by puncturing the wall of the right ventricle, rather than via a percutaneous approach. It has generally been performed as part of a combination "hybrid" procedure, which involves standard cardiac surgical techniques for correction of coexisting abnormalities, combined with a perventricular intervention for VSD closure. The technique has been investigated as an alternative to percutaneous transcatheter techniques combined with cardiac surgery, for use in the repair of complex congenital cardiac defects that are not readily amenable to these more established approaches.

Note: This document does not address the percutaneous transcatheter closure of ventricular septal defects.

Position Statement

Investigational and Not Medically Necessary:

Transmyocardial/perventricular device closure of ventricular septal defects is considered investigational and not medically necessary.

Rationale

Transmyocardial/perventricular device closure of VSDs involves deployment of an occlusive device via a right ventricular puncture and is being investigated as an alternative to a percutaneous transcatheter approach, particularly in infants or other individuals with poor vascular access. It has generally been reported, when performed in combination with cardiac surgery for coexisting abnormalities in a so-called "hybrid" procedure, as involving standard cardiac surgery performed in tandem with interventional transcatheter techniques for closure of a coexisting defect. It is reported that the perventricular approach may be performed, in some cases, without the need for cardiopulmonary bypass. Currently, these procedures are performed using the AMPLATZER® Muscular VSD occluder (AGA Medical Corporation, Golden Valley, MN), which is not FDA approved for this purpose.

The available literature on the transmyocardial/perventricular device closure technique is very limited. Very small numbers of cases were reported upon (6-14 per report, total of 40 cases), mostly by the same group of investigators and involving a single institution (Bacha, 2003, 2005; Bendaly, 2011; Holzer, 2004; Patel, 2005; Zhu, 2013). These case reports were also limited by short follow-up periods and lack of randomization. The published scientific evidence currently available is insufficient to demonstrate the safety and efficacy of transmyocardial/perventricular approaches to closure of VSDs, as compared to conventional treatment options.

Background/Overview

Ventricular septal defects (VSDs) may be congenital or an uncommon complication following a myocardial infarction. When there is a large opening between the ventricles, a large amount of oxygen-rich (red) blood from the heart's left side is forced through the defect into the right side. Then it is pumped back to the lungs, even though it has already been refreshed with oxygen. This is inefficient, because oxygenated blood displaces blood that needs oxygen. This means the heart, which must pump more blood, may enlarge from the added work. High blood pressure may occur in the blood vessels of the lungs, because more blood is present. Over time, this increased pulmonary hypertension may permanently damage the blood vessel walls.

If the opening between the ventricles is small, it does not strain the heart. In that case, the only abnormal finding is a loud murmur. Closing small ventricular septal defects may not be needed. They often close on their own in childhood or adolescence. However, if the opening is large, even in individuals with few symptoms, closing the hole in the first 2 years of life is recommended to prevent serious problems later. Repairing a VSD restores the blood circulation to normal. The transmyocardial approach, otherwise known as perventricular, is a hybrid procedure being investigated as an alternative to the transcatheter procedure in individuals with complex congenital cardiac defects. To date, no devices have been granted final FDA approval for this application.

Definitions

Ventricular septal defect (VSD): An opening in the wall between the right and left ventricles..

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary:
When the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

CPT  
33999 Unlisted procedure, cardiac surgery [when specified as transmyocardial transcatheter closure of ventricular septal defect, with implant, including cardiopulmonary bypass if performed]
   
ICD-10 Diagnosis  
  All diagnoses
   
References

Peer Reviewed Publications:

  1. Bacha EA, Cao QL, Galantowicz ME, et al. Multicenter experience with perventricular device closure of muscular ventricular septal defects. Pediatr Cardiol. 2005; 26(2):169-175.
  2. Bacha EA, Cao QL, Starr JP, et al. Perventricular device closure of muscular ventricular septal defects on the beating heart: technique and results. J Thorac Cardiovasc Surg. 2003; 126(6):1718-1723.
  3. Bacha EA, Hijazi ZM, Cao QL, et al. Hybrid pediatric cardiac surgery. Pediatr Cardiol. 2005; 26(4):315-322.
  4. Bendaly EA, Hoyer MH, Breinholt JP. Mid-term follow up of perventricular device closure of muscular ventricular septal defects. Catheter Cardiovasc Interv. 2011; 78(4):577-582.
  5. Diab K, Cao Q, Mora B, Hijazi ZM. Device closure of muscular ventricular septal defects in infants less than one year of age using the Amplatzer devices: feasibility and outcome. Catheter Cardiovasc Interv. 2007; 70(1):90-97.
  6. Holzer R, Balzer D, Cao QL, et al. Device closure of muscular ventricular septal defects using the Amplatzer muscular ventricular septal defect occluder: intermediate and mid-term results of a U.S. registry. J Am Coll Cadiol. 2004; 43(7):1257-1263.
  7. Patel HT, Hijazi ZM. Pediatric catheter interventions: a year in review 2004-2005. Curr Opin Pediatr. 2005; 17(5):568-573.
  8. Zhu D, Tao K, An Q, et al. Perventricular device closure of residual muscular ventricular septal defects after repair of complex congenital heart defects in pediatric patients. Tex Heart Inst J. 2013; 40(5):534-540.
Websites for Additional Information
  1. American Heart Association. Available at: http://www.heart.org. Accessed on December 14, 2016.
Index

AMPLATZER Device
CardioSeal® Device
Ventricular Septal Defect
VSD

The use of specific product names is illustrative only.  It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Document History

Status

Date

Action

Reviewed 02/02/2017 Medical Policy & Technology Assessment Committee (MPTAC) review. Updated Websites section.
Reviewed 02/04/2016 MPTAC review. Updated Rationale and References sections. Removed ICD-9 codes from Coding section.
Reviewed 02/05/2015 MPTAC review. Updated Description and References.
Reviewed 02/13/2014 MPTAC review.
Reviewed 02/14/2013 MPTAC review. Website updated.
Reviewed 02/16/2012 MPTAC review. Updated Websites.
  01/01/2012 Updated Coding section with 01/01/2012 CPT changes; removed codes 0166T, 0167T deleted 12/31/2011.
New 02/17/2011 MPTAC review. Initial document development. Transferred content addressing Transmyocardial/ Perventricular device closure of ventricular septal defects from SURG.00032.