This document addresses the transcatheter closure of patent foramen ovale and transcatheter or open left atrial appendage (LAA) closure when performed to prevent stroke using cardiac occlusion devices.

Note: This document does not address the percutaneous transcatheter closure of atrial septal defects (ASDs).

Note: This document does not address surgical ligation or amputation of the LAA when the surgical method does not involve use of an LAA device.

Note: Please see the following related document for additional information:

• SURG.00096 Surgical and Ablative Treatments for Chronic Headaches

Position Statement

Medically Necessary:

Transcatheter closure of a patent foramen ovale (PFO) using a U.S. Food and Drug Administration (FDA) approved device approved for that indication is considered medically necessary for:

1. The prevention of subsequent stroke in individuals with a history of cryptogenic stroke who:
   1. have failed conventional drug therapy (for example, warfarin); or
   2. are not candidates for conventional drug therapy; or
2. Individuals 60 years old and younger with a history of cryptogenic stroke who have:
   1. an atrial septal aneurysm; or
   2. a large interatrial shunt (see definition section).

Transcatheter closure of left atrial appendage (LAA) is considered medically necessary in individuals with non-valvular atrial fibrillation for the prevention of stroke when the following criteria are met:

1. Individual is a candidate for long-term anticoagulation therapy based upon their estimated risk of stroke and other thromboembolic events; and
2. Individual is ineligible for long-term oral anticoagulation therapy (for example, a direct oral anticoagulant [apixaban, dabigatran, edoxaban, or rivaroxaban] or warfarin) due to the presence of contraindication(s) (for example, an increased risk of bleeding), but is expected to be able to tolerate short-term oral anticoagulation necessary for device implantation.

Investigational and Not Medically Necessary:

Transcatheter closure of a patent foramen ovale for the prevention of stroke is considered investigational and not medically necessary when the criteria above are not met.

Transcatheter closure of a left atrial appendage is considered investigational and not medically necessary when the criteria above are not met.

Left atrial appendage closure via surgical (non-percutaneous) implantation of a device is considered investigational and not medically necessary for all indications.