SURG.00121 Transcatheter Heart Valve Procedures Form

This document addresses the transcatheter (percutaneous or catheter-based) approach for aortic or pulmonary heart valve replacement, transcatheter edge-to-edge repair (also referred to as transcatheter mitral valve repair using leaflet repair or percutaneous annuloplasty), and transcatheter tricuspid valve repair or replacement.

Position Statement

Medically Necessary:

Transcatheter Aortic Valve Replacement (TAVR):

TAVR using a U.S. Food and Drug Administration (FDA) approved device* is considered medically necessary when the following criteria have been met:

1. The individual has severe degenerative, native valve aortic stenosis demonstrated by one of the following:
   1. The aortic valve area (AVA) is equal to or less than 0.8 cm²; or
   2. The AVA index is equal to or less than 0.5 cm²/m²; or
   3. A mean aortic valve gradient of more than 40 mm Hg; or
   4. A peak aortic-jet velocity of more than 4.0 m/sec; and
2. Heart failure symptoms of New York Heart Association (NYHA) class II or greater; and
3. The individual is in one of the following categories:
   1. Age 65 years or older with any open surgical risk; or
   2. Age younger than 65 with intermediate or greater open surgical risk (predicted risk of surgical mortality at 30 days greater than or equal to 3%) as determined by at least two physicians.

Valve-in-valve TAVR implantation using an FDA approved device* is considered medically necessary for treatment when the following criteria are met:

1. The individual has failure (that is, stenosed, insufficient, or both) of previous open surgical bioprosthetic aortic valve; and
2. The individual is at high or greater risk for open surgical therapy (that is, Society of Thoracic Surgeons operative risk score greater than or equal to 8% or at a 15% or greater risk of operative mortality at 30 days) as determined by at least two physicians.

*Note: Please refer to background section of document for list of FDA approved transcatheter heart valve (THV) devices used for TAVR

Transcatheter Mitral Edge-to-Edge Repair:

Transcatheter mitral edge-to-edge repair/transcatheter mitral valve repair using an FDA approved device** is considered medically necessary when individual has one of the following conditions:

1. Chronic degenerative (primary) mitral regurgitation (MR) and meets all the following criteria;
   1. Graded as moderate-to severe (3+ to 4+) MR; and
   2. Severely symptomatic heart failure (NYHA class III or IV); and
   3. Echocardiogram demonstrates that the primary regurgitant jet results from malcoaptation of the A2 and P2 scallops of the mitral valve; and
   4. Prohibitive surgical risk for open surgical therapy (predicted risk of surgical mortality greater than or equal to 8% at 30 days) as determined by at least two physicians (Multidisciplinary Heart valve team);
      or
2. Functional (secondary) MR and meets all the following criteria:
   1. Graded as moderate-severe (3+ to 4+) MR; and
   2. Severely symptomatic heart failure (NYHA class III or IV); and
   3. Echocardiogram demonstrates that the primary regurgitant jet results from malcoaptation of the A2 and P2 scallops of the mitral valve; and
   4. MR severity persist despite maximally tolerated guideline-directed medical therapy as determined by at least two physicians (Multidisciplinary Heart Team).

**Note: Please refer to background section of document for list of FDA approved transcatheter mitral valve repair devices.

Transcatheter Pulmonary Valve (TPV):

TPV implantation with an FDA approved device*** is considered medically necessary when the following criteria are met:

1. Dysfunctional right ventricular outflow tract (RVOT) tract (native, patched or implanted conduit) with one of the following clinical indications for intervention:
   1. moderate or greater pulmonic regurgitation; or
   2. pulmonic stenosis with a mean RVOT gradient greater or equal to 35 mm Hg.

***Note: Please refer to background section of document for list of FDA approved TPVs.

Not Medically Necessary:

Transcatheter (aortic, pulmonic, or valve-in-valve) valve replacement is considered not medically necessary when the criteria above are not met.

Transcatheter mitral edge-to-edge repair/transcatheter mitral valve repair is considered not medically necessary for the treatment of primary or secondary (functional) MR when the criteria above are not met.

Investigational and Not Medically Necessary:

TAVR cerebral protection devices (for example, Sentinel^™ Cerebral Protection System) are considered investigational and not medically necessary for all indications.

Transcatheter mitral edge-to-edge repair/transcatheter mitral valve repair is considered investigational and not medically necessary for all other indications.

Valve-in-valve transcatheter mitral valve replacement is considered investigational and not medically necessary for all indications.

Transcatheter mitral valve repair using percutaneous annuloplasty (for example, CARILLON Mitral Contour System) is considered investigational and not medically necessary for all indications.

Transcatheter tricuspid valve repair or replacement is considered investigational and not medically necessary for all indications.