FDA Alert: Patient Deaths and Serious Adverse Events Reported for SentreHEART Lariat Suture Delivery DeviceJul 15, 2015
The Food and Drug Administration (FDA) has issued an alert to health care providers and patients about reports of deaths and serious adverse events associated with the use of SentreHEART's Lariat Suture Delivery Device and associated devices.
The device is used to close the left atrial appendage, a pouch-like region of the left atrium in the heart, to prevent stroke in patients with irregular heart rhythm (atrial fibrillation).
The FDA identified 45 adverse events through June 30, 2015 that occurred in patients undergoing LAA closure procedures with the Lariat Suture Delivery Device and/or associated devices. The reports describe six patient deaths and other serious complications including laceration and/or perforation of the heart, complete LAA detachment from the heart, bleeding (hemorrhage), low blood pressure (hypotension), fluid collection around the heart (pericardial effusion), fluid collection around the heart that causes low blood pressure and decreased heart function leading to shock (cardiac tamponade), and fluid collection around the lung (pleural effusion). Of the 45 adverse events reported to the FDA, approximately 75 percent (34) resulted in the need for emergency heart surgery.
Some physicians are using SentreHEART's Lariat Suture Delivery Device along with three other associated devices (the EndoCATH Occlusion Balloon Catheter, the SofTIP Guide Cannula, and the FindrWIRZ System) to close the left atrial appendage in patients with atrial fibrillation. The FDA has not evaluated the safety and effectiveness of this use of the devices and the agency advises physicians to be aware of the risks when using the devices in this way.
Atrial fibrillation-an irregular and often rapid heart rate that commonly causes poor blood flow to the body-has an estimated prevalence of 2.7 to 6.1 million people in the United States. Patients with atrial fibrillation have a five-fold increased incidence of stroke. This risk has traditionally been managed with the blood-thinning drug warfarin, according to the authors of a study about the Lariat device published in May in JAMA Internal Medicine. Warfarin increases the risk of bleeding, it requires regular monitoring of coagulation levels, and there is a high discontinuation rate among patients, the authors report. Newer anticoagulants avoid some of these issues, but they also have concerns about bleeding risk, they are expensive, and they lack antidotes to serious bleeding. Ninety percent of blood clots causing AF-related strokes arise from the left atrial appendage (LAA). "Many of the limitations of oral anticoagulant use could theoretically be overcome with minimally invasive closure of the LAA," the JAMA authors write.
The FDA advises physicians to carefully consider treatment options to reduce the risk of stroke in patients with atrial fibrillation. Before any treatment is started, the patient should be informed of the benefits and risks of the available treatment options to help prevent stroke.
The FDA encourages health care professionals and patients to report adverse events or side effects related to the use of these devices to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: www.fda.gov/MedWatch/report.