Safety of Left Atrial Appendage Lariat Device | Journal Scan

May 04, 2015
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Authors:
Chatterjee S, Herrmann HC, Wilensky RL, et al.
Citation:
Safety and Procedural Success of Left Atrial Appendage Exclusion With the Lariat Device: A Systematic Review of Published Reports and Analytic Review of the FDA MAUDE Database. JAMA Intern Med 2015;May 4:[Epub ahead of print].
Summary By:
Debabrata Mukherjee, MD, FACC

Study Questions:

What is the safety and procedural success of the Lariat device?

Methods:

The investigators performed a formal analytic review of the Food and Drug Administration (FDA) MAUDE (manufacturer and user facility device experience) database to compile adverse events from real-world practice with the Lariat. PubMed, EMBASE, CINAHL, and the Cochrane Library were searched from January 2007 through August 2014 to identify all studies reporting on usage of the Lariat device in three or more patients. Two physicians abstracted data in duplicate. Events from published literature were pooled using a generic inverse variation weighting with a random-effects model. Cumulative and individual adverse events were also reported using the FDA MAUDE database. The main outcome was procedural adverse events and success rates.

Results:

In the systematic review, specific complication weighted for inverse of variance of individual studies was urgent need for cardiac surgery (2.3%; 7 of 309 procedures) and death (0.3%; 1 of 309 procedures). Procedural success was 90.3% in the published literature. From the MAUDE database, five adverse events were identified that noted pericardial effusion and death, while an additional 23 reported need for urgent cardiac surgery without mention of death.

Conclusions:

The authors concluded that there are significant risks of major adverse cardiac events with off-label use of the Lariat device.

Perspective:

This systematic review of the literature and analysis of the FDA MAUDE database found moderately high rates of procedural success, but a potentially concerning safety profile of the Lariat device used for left atrial appendage exclusion. Since the Lariat device is being used primarily for left atrial appendage exclusion, high-quality prospective randomized studies are indicated to assess safety and efficacy prior to widespread use by clinicians. For now, clinicians may want to refrain from using the Lariat device for left atrial appendage exclusion until additional safety data are available.

Keywords: Arrhythmias, Cardiac, Atrial Appendage, Cardiac Surgical Procedures, Death, Off-Label Use, Pericardial Effusion, Primary Prevention, Prospective Studies, Risk, United States Food and Drug Administration


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