Point32 Percutaneous Left Atrial Appendage Closure to Reduce Stroke Risk in Patients with Atrial Fibrillation (WatchmanTM Device) Form

Harvard Pilgrim HealthCare Medical Policy

Percutaneous Left Atrial Appendage Closure to Reduce Stroke Risk in Patients with Atrial Fibrillation (WatchmanTM Device)

Subject:

Percutaneous Left Atrial Appendage Closure to Reduce Stroke Risk in Patients with Atrial Fibrillation (WatchmanTM Device)

Background:

Atrial fibrillation (AF) is a rapid, irregularly irregular atrial cardiac rhythm brought on when the two upper chambers (atria) of the heart no longer contract together in a coordinated manner. AF is one of the most common arrhythmias, affecting about 2.3 million adults in the US. Prevalence increases with age; almost 10% of people over the age of 80 are affected. AF tends to occur in patients with a heart disorder. Atrial thrombi often form in patients with AF due to the slowing of blood flow that results when the atria no longer contract normally, causing a significant risk of embolic stroke.

The WATCHMAN LAA closure technology consists of a delivery catheter and a device that is permanently implanted in the left atrial appendage (LAA) of the heart. The device, often referred to as the WATCHMAN, prevents LAA blood clots from entering the bloodstream and potentially causing a stroke. It is used in patients who have atrial fibrillation not related to heart valve disease.

Policy and Coverage Criteria:

Harvard Pilgrim Health Care (HPHC) considers percutaneous left atrial appendage (LAA) closure using the Watchman device as reasonable and medically necessary to reduce the risk of thromboembolism from the LAA in individuals with nonvalvular atrial fibrillation when documentation confirms ALL the following:

• Member is at increased risk for stroke and systemic embolism; AND
• Member is recommended for anticoagulation therapy; AND
• Member is deemed by their physicians to be suitable for warfarin; AND
• Member has an appropriate rationale to seek a non-pharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device compared to warfarin.

Exclusions:

Harvard Pilgrim Health Care (HPHC) considers percutaneous left atrial appendage closure using any device other than the Watchman device (e.g., Amplatzer Cardiac Plug [ACP], Amplatzer Amulet and Lariat suture delivery device) as experimental/investigational.