BlueCross BlueShield of Tennessee Medical Policy Manual

Percutaneous Left-Atrial Appendage Closure Devices for Stroke Prevention in Atrial Fibrillation

DESCRIPTION

Left-atrial appendage (LAA) closure devices (e.g. Watchman™) consist of a permanently implanted device in the left atrial appendage of the heart. The device is delivered via catheter through a vein in the leg. The catheter advances through the bloodstream until it reaches the right atrium, advances through an incision in the septum and opens like an umbrella in the left atrium. Once in place a thin layer of tissue grows over the device and keeps clots from entering the bloodstream, thus preventing strokes.

Strokes associated with atrial fibrillation are primarily embolic in nature and tend to be more severe than the typical ischemic stroke, causing higher rates of mortality and disability. The lack of atrial contractions in atrial fibrillation leads to blood stasis in the left atrium, and this low flow state increases the risk for thrombosis. It has been estimated that 90% of thrombi occur in the LAA.

The main treatment for stroke prevention in atrial fibrillation is anticoagulation medications. While anticoagulation is effective for stroke prevention, increased risk of bleeding is present. Until therapeutic anticoagulation is achieved, frequent monitoring and adjustments, as well as lifestyle changes, are required. The balance of risks and benefits associated with implantation of this device for stroke prevention as an alternative to systemic anticoagulation must be made on an individual basis.

Only one percutaneous LAA closure device, to date, has received FDA approval as a non-pharmacologic alternative to anticoagulation for stroke prevention in atrial fibrillation (Watchman™). Other devices (e.g., Lariat® Loop Applicator, Amplatzer Amulet, and Cardioblate® closure device) are in development or undergoing clinical trials.

POLICY

MEDICAL APPROPRIATENESS

IMPORTANT REMINDERS

ADDITIONAL INFORMATION  

The CHADS2 score is a clinical prediction rule for estimating the risk of stroke in patients with non-rheumatic atrial fibrillation (AF), a common and serious heart arrhythmia associated with thromboembolic stroke. The CHA2DS2-VASc score is a refinement of CHADS2 score and extends the latter by including additional common stroke risk factors, that is, age 65-74, female gender and vascular disease. A higher score corresponds to a greater risk.

 

Condition

Point

C

Congestive heart failure

1

H

Hypertension (140/90)

1

A

Age ≥ 75 years

2

D

Diabetes Mellitus

1

S

Prior Stroke or TIA

2

V

Vascular disease

1

A

Age 65-74 years

1

S

Sex category (female)

1

SOURCES

American Heart Association/American Stroke Association (2014) Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack. Retrieved October 23, 2017 from http://stroke.ahajournals.org/content/strokeaha/early/2014/04/30/STR.0000000000000024.full.pdf.

Bajaj, N., Parashar, A. Agarwal, S., MD, Sodhi, N., Poddar, K., Garg A., el al., (2014) Percutaneous left atrial appendage occlusion for stroke prophylaxis in nonvalvular atrial fibrillation. Cardiologic Interventions, 7 (3), 296-304. (Level 2 evidence)

BlueCross BlueShield Association. Medical Policy Reference Manual. (5:2017). Percutaneous left atrial appendage closure devices for stroke prevention in atrial fibrillation (2.02.26). Retrieved October 23, 2017 from BlueWeb. (56 articles and/or guidelines reviewed)

Centers for Medicare & Medicaid Services. CMS.gov. NCD for percutaneous left atrial appendage closure (LAAC) (20.34). retrieved October 23, 2017 from www.cms.gov.

Lakkireddy, D., Afzal, M., Lee, R., Nagaraj, H., Tschopp, D., Gidney, B., et al. (2016). Short and long-term outcomes of percutaneous left atrial appendage suture ligation: results from a US multicenter evaluation. Heart Rhythm. 13 (5), 1030-6. Abstract retrieved October 21, 2016 from PubMed database.

National Institute for Health and Clinical Excellence (NICE). (2010, June). Percutaneous occlusion of the left atrial appendage in non-valvular atrial fibrillation for the prevention of thromboembolism. Retrieved October 21, 2016 from http://www.nice.org.uk.

Sahay, S., Nombela-Franco, L., Rodes-Cabau, J., Jimenez-Quevedo, P., Salinas, P., Biagioni, C., et al. (2017). Efficacy and safety of left atrial appendage closure versus medical treatment in atrial fibrillation: a network meta-analysis from randomized trials. Heart, 103, 139-147. (Level 1 evidence)

Winifred S. Hayes, Inc. (2013, January last update search 2017, June). Percutaneous left atrial appendage closure to reduce stroke risk in patients with atrial fibrillation. Retrieved October 23, 2017 from: www.Hayesinc.com. (106 articles and/or guidelines reviewed)

ORIGINAL EFFECTIVE DATE:  10/8/2011

MOST RECENT REVIEW DATE:  11/9/2017

ID_BA

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

This document has been classified as public information.