Off-Label Use of Device to Prevent Stroke in Patients With AF Is Prevalent, Dangerous - Lariat

Just in case you have this device contact your doctor for an evaluation of risks.
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The Lariat device, which has been cleared by the US Food and Drug Administration (FDA) for soft tissue approximation during surgical procedures, is associated with a significant incidence of death and urgent cardiac surgery during its frequent off-label use to prevent stroke in patients with atrial fibrillation.
Following a systematic review of case reports and an FDA safety database, researchers at the University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, are calling for formal controlled investigations into the safety and efficacy of off-label use of the Lariat device, which has never been approved for treatment of this condition.
Their findings are published this week in JAMA Internal Medicine.
“Not only do we believe that high-quality, randomised clinical trials are necessary to determine the safety of the Lariat device for off-label procedures, but our analysis raises broader issues with the FDA 510(k) clearance protocol for medical devices,” said senior author Jay Giri, MD, University of Pennsylvania. “We believe there needs to be a method for reassessing the safety of a device that has been cleared for one use but is being frequently used for a different purpose in real-world practice."
“The 510(k) clearance protocol is providing a regulatory loophole that allows manufacturers to avoid full safety and efficacy testing of devices cleared for one purpose, but used in practice for another higher-risk application,” he said. “”In addition to the Lariat, this issue could be important for other devices used in complex procedures that have been cleared through the 510(k) pathway.”
The current study consisted of 2 sources: a systemic review of published reports, and an analytic review of the FDA Manufacturer and User Facility Device Experience (MAUDE) database. For the systematic review, the researchers searched PubMed, EMBASE, CINAHL, and the Cochrane Library for any reports of outcomes associated with the use of the Lariat device for left atrial appendage exclusion.
The researchers found 7 cases of urgent need for cardiac surgery following use of the device (2.3% of the 309 procedures reviewed) and 1 death (0.3% of the 309 procedures), with an overall procedural success rate of 90.3%. The analytic review of the FDA MAUDE database identified 5 adverse event reports that noted death and another 23 reports of cases necessitating urgent cardiac surgery.
“The Lariat is an ingenious piece of engineering for closing the left atrial appendage, but ingenuity does not guarantee safety and efficacy,” said Dr. Giri. “The Lariat must be assessed as a device for left atrial appendage exclusion with randomised, controlled trials before widespread use is adopted by the medical community.”
SOURCE: University of Pennsylvania School of Medicine