According to a report published online this week in JAMA Internal Medicine, off-label use of a suturing device in patients with atrial fibrillation is potentially dangerous to the patients.
A group of cardiology researchers from around the country conducted a systematic review of studies found through searches of PubMed, EMBASE, CINAHL, and the Cochrane Library for January 2007 through August 2014. They identified all studies reporting use of the SentreHEART’s Lariat device in three or more patients. They examined the Food and Drug Administration MAUDE database for adverse events reports related to Lariat use, HealthDay News reports.
From five reports of Lariat device use in 309 participants, they found Lariat had an overall success rate of 90 percent. But they also found seven cases of urgent need for cardiac surgery following use of the device (approximately 2 percent of the 309 procedures reviewed), and one death, according to HealthDay News.
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 embolic stroke. This risk has traditionally been managed with the drug warfarin, the authors explain. But warfarin elevates the risk of bleeding, requires regular monitoring of coagulation levels, and has high discontinuation rates. According to the authors, other anticoagulants “circumvent some of these issues” but have raised concerns about bleeding risk, greater cost, and the lack of direct-acting antidotes when bleeding occurs. 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 authors write.
The authors said formal analytic review of the MAUDE (Manufacturer and User Facility Device Experience) database revealed five deaths and another 23 cases of urgent cardiac surgery resulting from the procedure, HealthDay News reports. “We found a handful of deaths, and a greater handful in which there was the need for an urgent open-heart surgery to correct a problem” involving bleeding or damage done to the heart during the procedure, lead researcher Jay Giri, MD, MPH, told HealthDay. Dr. Giri is an assistant professor of cardiovascular medicine with the Perelman School of Medicine at the University of Pennsylvania in Philadelphia.
SentreHEART said it plans to seek FDA permission for clinical trials focused on this off-label use. “It is important to note that it is not unusual for device manufacturers to obtain marketing authorization for one use, and then subsequently seek additional indications for use,” the company said in a statement. SentreHEART said the authors did not contact the company. Further, the company says there is evidence of the device’s safety. SentreHEART emphasized in its statement that the company does not promote, market, or advertise the device as a treatment for atrial fibrillation.