FDA warns of serious adverse events with LAA closure via suture delivery device

The FDA has issued a safety announcement warning of deaths and other serious adverse events associated with left atrial appendage closure via a suture delivery device in patients with atrial fibrillation.

According to the announcement, physicians have used the Lariat device (SentreHeart) and associated devices off-label to close the left atrial appendage (LAA) to prevent stroke in patients with AF, but the safety and efficacy of this treatment has yet to be established. The device received 501(k) clearance in 2006 for suture placement during surgery, but has not been approved or undergone clinical testing for LAA exclusion in AF.

In a search of the Manufacturer and User Facility Device Experience (MAUDE) database, the FDA observed 45 adverse events through June 30 related to the use of the Lariat device for LAA closure. The events included six deaths, as well as incidences of laceration and/or perforation of the heart, complete LAA detachment, hemorrhage, hypotension, pericardial or pleural effusion and cardiac tamponade. Emergency heart surgery was required to treat 34 of the reported events, according to the announcement.

In a review published in JAMA Internal Medicine earlier this year, researchers observed a 90.3% procedure success rate for LAA exclusion via the Lariat device, but also identified 35 reports of adverse events in the FDA MAUDE database, including five deaths and 23 cases of urgent cardiac surgery. The researchers called for a reassessment of the safety of the Lariat device, as well as randomized controlled trials evaluating it as a method for LAA exclusion, “before widespread use is adopted by the medical community.”

The FDA recently approved initiation of the randomized, controlled AMAZE trial to evaluate the use of the Lariat device in addition to pulmonary vein isolation for LAA closure in patients with AF.