Archived Policies - Surgery


Percutaneous Heart Valve Replacement

Number:SUR717.015

Effective Date:03-01-2011

End Date:06-14-2011

Coverage:

Percutaneous heart valve replacement (PHV) is considered experimental, investigational and unproven by any method.

Description:

The heart has four chambers which receive and pump blood.  Blood flows through these chambers with the assistance of valves that open and close, serving as a gate.  A valve may be defective for many reasons, usually because it doesn’t open or close properly causing leaks or stenosis.  When the treating physician determines that a valve needs to be replaced, the most common treatment has traditionally been performed with open-heart surgery.  

Percutaneous heart valve replacement (PHV) is an emerging, catheter-based technology that allows for implantation of a prosthetic valve without open-heart surgery.  PHV replacement is the delivery of a prosthetic heart valve via a catheter inserted either through a vein or artery (femoral vein; femoral, subclavian, or axillary arteries; or the ascending aorta) or through the apex of the heart via an incision in the chest wall (transapical approach).  Edwards Lifesciences® received approval to begin a clinical trial of its Edwards SAPIEN™ Transcatheter heart valve technology in patients with aortic stenosis who are considered high-risk for conventional open-heart valve surgery.

Rationale:

A peer-review literature search was performed through November 2010. 

In 2007, Edwards Lifesciences began a randomized, controlled clinical trial of its Edwards SAPIEN Transcatheter heart valve technology in patients with aortic stenosis who are considered high-risk for conventional open-heart valve surgery.  Subjects will be randomized to either the investigational device, or current surgical or medical management.   The anticipated completion date of the clinical trial is 2014 with an estimated enrollment of 1,040.  No PHV is approved by the FDA at this time.  Pending publication of this trial, available evidence is lacking to warrant coverage of this procedure and/or device.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

None


Medicare Coverage:

The information contained in this section is for informational purposes only.  HCSC makes no representation as to the accuracy of this information.  It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position.  Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been developed since this medical policy document was written.  See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

The PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial. Available at <http://www.clinicaltrials.gov> (Accessed December 6, 2010).

Edwards SAPIEN Transcather Heart Valve. Available at <www.edwards.com> (Accessed December 6, 2010).

Coeytaux, R., Williams, J. et al. Narrative Review: Percutaneous Heart Valve Replacement for Aortic Stenosis: State of the Evidence. Ann Intern Med (2010) 153(5):314-24.

Policy History:

3/1/2011          New Medical Document converted from position statement.  Percutaneous heart valve replacement is considered experimental, investigational and unproven by any method. 

1/1/2011          Position Statement. Percutaneous heart valve replacement is considered experimental, investigational and unproven by any method.

Archived Document(s):

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