Percutaneous Left Atrial Appendage Closure Devices

Policy ID: S-245-006

Section: Surgery

Effective Date: September 07, 2020

Last Reviewed: July 22, 2020

Description

A left atrial appendage closure (LAA) device is an implant based alternative to anticoagulation. The closure device is used to reduce the risk of thromboembolism from the LAA from entering the bloodstream and causing a stroke in individuals with non-valvular atrial fibrillation (NVAF) who are at increased risk for stroke and systemic embolism.

Criteria

The use of a device with U.S. Food and Drug Administration (FDA) approval for percutaneous LAA closure (i.e., Watchman^TM) may be considered medically necessary for the prevention of stroke in individuals with NVAF, when BOTH of the following criteria are met:

There is an increased risk of stroke and systemic embolism based on CHADS2* greater than or equal to two (2) or CHA2DS2-VASc** score greater than or equal to three (3) (see tables below) and systemic anticoagulation therapy is recommended; and
The long-term risks of systemic anticoagulation outweigh the risks of the device implantation.

A percutaneous LAA closure device for any other indication is considered experimental/investigational, and therefore non-covered covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Procedure Codes

33340

The use of other percutaneous LAA closure devices, including but not limited to the LARIAT, PLAATO, and AMPLATZER devices, for stroke prevention in individuals with atrial fibrillation is considered experimental/investigational because the safety and/or effectiveness of these devices cannot be established by the available published peer-reviewed literature.

Note: *CHADS2 score: Congestive heart failure, hypertension, age greater than 75, diabetes, stroke/transient ischemia attack/thromboembolism.

Note: ** CHA2DS2-VASc score: Congestive heart failure, hypertension, age greater than or equal to 65, diabetes, stroke/transient ischemia attack/thromboembolism, vascular disease, sex category.

Note: NVAF is defined as a rhythm disturbance that occurs in the absence of rheumatic mitral stenosis, a mechanical or bioprosthetic heart valve or mitral valve repair.

CHADS2 and CHADS2-VASc Scores to Predict Ischemic Stroke Risk in Individuals with Atrial Fibrillation

Risk Scheme

Low Risk

Intermediate Risk

High Risk

CHADS₂

(2001) classic

Score 0

Score 1-2

Score 3-6

CHADS₂—revised

Score 0

Score 1

Score 2-6

The 2009 Birmingham Schema Expressed as a Point-Based Scoring System, With the Acronym CHA2DS2-VASc

Risk Factor	Score
Congestive heart failure/LV dysfunction	1
Hypertension	1
Age ≥ 75 y	2
Diabetes mellitus	1
Stroke/TIA/TE	2
Vascular disease (prior myocardial infarction, peripheral artery disease, or aortic plaque)	1
Age 65-74 y	1
Sex category of female (female sex confers higher risk)	1

Diagnosis Codes

Covered Diagnosis Codes for Procedure Code 33340

I48.0

I48.11

I48.19

I48.20

I48.21

I48.91

Professional Statements and Societal Positions Guidelines

American Heart Association – 2019

The American Heart Association, in collaboration with the American College of Cardiology and the Hearth Rhythm Society(2019)published anupdate of their guideline for the management of patients with atrial fibrillation. A new recommendation in the guideline states: "Percutaneous LAA occlusion may be considered in patients with AF at increased risk of stroke who have contraindications to long-term anticoagulation." The class of recommendation is IIb and the level of evidence is B_NR (moderate quality of evidence, non-randomized). No other LAA closure devices are mentioned in the guideline.

ND Committee Review

Internal Medical Policy Committee 7-22-2020 New policy

Links

References

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving and the Company reserves the right to review and update medical policy periodically.

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