Medical Policy

 

Subject: Transmyocardial/Perventricular Device Closure of Ventricular Septal Defects
Document #: SURG.00123 Publish Date:    03/29/2018
Status: Reviewed Last Review Date:    02/27/2018

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, and it is for the repair of complex congenital cardiac defects that are not readily amenable to 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 an occluder device such as the AMPLATZER® Muscular VSD occluder (AGA Medical Corporation, Golden Valley, MN) which is not FDA approved for this purpose.

Several small studies, mostly from single centers and with a small number of subjects, have reported on the transmyocardial/perventricular approach (Bacha, 2003, 2005; Bendaly, 2011; Holzer, 2004; Kang, 2015; Molaei, 2017; Patel, 2005; Zhu, 2013). Although promising, these reports were limited by a retrospective design, short follow-up period, or lack of randomization.

In a multicenter, retrospective cohort study, Gray and colleagues (2017) evaluated acute and midterm outcomes of hybrid perventricular VSD closure that were performed with the Amplatzer occluder device. The researchers categorized 47 subjects into 2 groups: subjects who had a simple perventricular closure and subjects who had a complex perventricular closure that was combined with another cardiac surgical procedure. The median age was 5.2 months. The hybrid perventricular procedure was successful in 100% of the simple group (n=22) and in 84% of the complex group (n=21/25). Overall, serious adverse events (SAE) occurred in 9/47 subjects (19%). In the simple group, there were 2/22 (9%) SAEs including a malpositioned VSD device 4 days postop and a left pseudoaneurysm 14 months postop. In the complex group, there were 7/25 (28%) SAEs including perforation by the delivery sheath, AV valve insufficiency resulting in transplantation, and 4 deaths. Of the 39 subjects available at a median follow-up of 19.2 months, 90% (35/39) were free from cardiac symptoms and had normal biventricular systolic function. Limitations of the study included the retrospective design, small sample size, variability in the complexity of the VSDs, and short follow-up. The authors stated that “longer-term studies are necessary to evaluate for any late device-related adverse outcomes.”

Voitov and colleagues (2017) performed a prospective randomized trial to compare the perventricular device closure (PVDC) approach to conventional surgery for VSD closure. A total of 640 subjects were randomized to either have PVDC surgery with a Lepu occluder (Lepu Medical Technology Co., Ltd., Beijing, China) (n=320) or conventional surgery (n=320). The subjects, who were an average of 36.2 months old, were examined at 3, 6, 12 and 24 months post-procedure. The success rate in the PVDC group was 96.6%; however, 11 PVDC procedures (3.4%) had to be converted to conventional surgery: 1 procedure (0.3%) due to a complete AV block that was resolved after conversion, 6 procedures (1.9%) due to a > 3 mm residual shunt, and 4 procedures (1.3%) due to the occluder size not matching the VSD diameter. During surgery, blood loss was 27.6 ml in the PVDC group and 38 ml in the conventional group (p=0.015). Intraoperative blood transfusions were given to 285 subjects (86.1%) in the conventional group due to cardiopulmonary bypass priming, but none were needed in the PVDC group (p<0.001). Postoperatively, 3 subjects (1.0%) in the PVDC group underwent a pericardiocentesis for pericardial effusion compared to 1 subject (0.3%) in the conventional group (p=0.284). At discharge, 34 subjects in the conventional group (10.3%) and 17 subjects (5.5%) in the PVDC group had a trivial residual shunt (< 2 mm) (p=0.026). Pulmonary artery pressure was reduced from 35.9 mmHg to 23.9 mmHg in the PVDC group and from 36.1 mmHg to 24.4 mmHg in the conventional group, but the difference between the groups was not statistically significant (p=0.418). At 24 months post-procedure there were no deaths. The conventional group had more residual shunts, but the researchers noted that the reason could be from the technique used. The authors concluded that, compared to conventional surgery, the PVDC approach is “less traumatic, reduces the operation time and ICU and hospital stays, and provides excellent cosmetic results.” Limitations of the study included a short follow-up duration, loss to follow-up, and data from only a single center.

The published scientific evidence currently available is insufficient to demonstrate the long-term 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 blood from the heart's left side is pumped through the defect into the right side and to the lungs, following the principle of blood flowing from a higher pressure to a lower pressure as the lung’s blood pressure is normally much lower than the systemic pressure. This extra blood pumping to the lungs creates inefficiency. Normally, half of the body’s blood is flowing through the right side of the heart to the lungs, and half is flowing through the rest of the body. The extra blood flowing into the lungs (pulmonary circulation) can interfere with normal lung function. The extra blood in the circulatory system causes the heart to try to compensate by getting larger. It can do this to a point, but eventually this enlargement and extra work can lead to heart failure. Additionally, the lungs compensate for the added blood flow by increasing the resistance in the lung’s blood vessels. Over time, these changes in the lungs’ blood vessels cause permanent damage and lead to a condition known as pulmonary hypertension.

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, except perhaps to try to remove a possible site of infection known as endocarditis. These holes often close on their own during early childhood. However, if the opening is large, closing the hole in the first 2 years of life is recommended even in individuals with few symptoms 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. Gray RG, Menon SC, Johnson JT, et al. Acute and midterm results following perventricular device closure of muscular ventricular septal defects: a multicenter PICES investigation. Catheter Cardiovasc Interv. 2017; 90(2):281-289.
  7. 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.
  8. Kang SL, Tometzki A, Caputo M, et al. Longer-term outcome of perventricular device closure of muscular ventricular septal defects in children. Catheter Cardiovasc Interv. 2015; 85(6):998-1005.
  9. Molaei A, Afrasiabi A, Bilejani E, Samadi M. Perventricular muscular ventricular septal defect (VSD) closure under epicardial echocardiography guidance: a case report. J Tehran Heart Cent. 2017; 12(3):138-141.
  10. Patel HT, Hijazi ZM. Pediatric catheter interventions: a year in review 2004-2005. Curr Opin Pediatr. 2005; 17(5):568-573.
  11. Voitov A, Omelchenko A, Gorbatykh Y, et al. Outcomes of perventricular off-pump versus conventional closure of ventricular septal defects: a prospective randomized study. Eur J Cardiothorac Surg. 2017; 51(5):980-986.
  12. 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 November 15, 2017.
Index

AMPLATZER Device
CardioSeal® Device
Perventricular Device Closure
Transmyocardial Device Closure
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

02/27/2018

Medical Policy & Technology Assessment Committee (MPTAC) review. The document header wording updated from “Current Effective Date” to “Publish Date.” Updated Rationale, Background, References and Websites sections.

Reviewed

02/02/2017

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.