A systematic review of databases found that off-label use of the Lariat snare device for left atrial appendage (LAA) exclusion was associated with adverse events, including death and urgent cardiac surgery.
Lead researcher Saurav Chatterjee, MD, of the Division of Cardiology at St. Lukes–Roosevelt Hospital Center of the Mount Sinai Health System in New York, and colleagues published their findings online in JAMA Internal Medicine on May 4.
In 2006, the FDA granted the device 510(k) class II clearance for soft-tissue approximation. Although the Lariat (SentreHEART) is not approved for LAA closure, the researchers said it is commonly used for transcatheter LAA exclusion in patients with atrial fibrillation.
In this study, researchers reviewed reports of adverse events and procedural success from January 2007 through August 2014. They also searched the FDA’s online Manufacturer and User Facility Device Experience (MAUDE) database.
When examining the medical literature, they identified 309 procedures using the Lariat device, of which 90.3 percent led to successful closure of the LAA. Seven individuals underwent urgent cardiac surgery following the procedures, while one person died in the hospital.
The MAUDE database included 35 adverse event reports from the beginning of 2009 through July 2014. Five of the reports mentioned pericardial effusion and in-hospital death, 22 mentioned pericardial effusion and urgent cardiac surgery, one mentioned urgent cardiac surgery but not pericardial effusion and seven mentioned the urgent placement of a pericardial drain to address a pericardial effusion. The researchers said 35.5 percent of the procedures were successful.
The researchers said 54.3 percent of the complications were due to problems with the Lariat device/suture tightener, while 40 percent were due to the FindWIRZ magnetic wires used for device deployment.
They wrote that their analysis had some limitations, including that reports to the MAUDE database were not independently verified, the studies from the systematic review were uncontrolled and they did not compare the Lariat with other devices or procedures.
Despite the potential drawbacks to their analysis, the researchers said randomized trials should be initiated before the Lariat is widely used for LAA exclusion.