Description

A leadless cardiac pacemaker is a small, battery-operated electrical device placed in the right ventricle of the heart that is purported to aid in maintaining a regular heart rhythm. The device is delivered directly to the ventricle through a catheter inserted into the femoral vein and attaches to the cardiac tissue with fixation tines or coils. Unlike traditional pacemakers, leadless cardiac pacemakers do not require intravascular leads. Examples of leadless cardiac pacemakers approved by the US Food & Drug Administration (FDA) include, but may not be limited to, Aveir VR Leadless System and Micra Transcatheter Pacing System (Micra AV2, Micra VR2).

Leadless pacemakers are currently only available as single-chamber devices, while conventional transvenous pacemakers are available in single- or dual-chamber forms. Investigational dual-chamber leadless devices are currently in clinical trials which purportedly regulate the heart rate synchronously between leadless pacemakers placed in the right ventricle and the right atrium. All pacemakers require routine in-person or telephonic checks by a cardiologist every 3 to 6 months to ensure they are working as intended. The leadless pacemaker battery is intended to last for 5 to 17 years which is similar to those in transvenous pacemakers.

Purported benefits of a leadless cardiac pacemaker include elimination of lead failure or migration, blood clots or infection that may occur with conventional transvenous pacemakers. A pacemaker is generally indicated for a symptomatic individual experiencing conditions including, but not limited to, bradycardia and/or atrial fibrillation.

Coverage Determination

Humana members may NOT be eligible under the Plan for single- or dual-chamber leadless cardiac pacemakers. These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Note: The criteria for leadless cardiac pacemakers are not consistent with the Medicare National Coverage Policy and therefore may not be applicable to Medicare members. Refer to the CMS website for additional information.

Additional information about cardiac arrhythmias may be found from the following websites:

Background

• American Heart Association
• National Library of Medicine

Medical Alternatives

Alternatives to leadless cardiac pacemakers include, but may not be limited to, the following:

• Conventional transvenous pacemaker

Physician consultation is advised to make an informed decision based on an individual's health needs.