A report published online this week in JAMA Internal Medicine indicates that off-label use of a suturing device in patients with atrial fibrillation is potentially dangerous to the patients. Some patients have required open-heart surgery after the procedure and one death has been reported.
A group of ten cardiology researchers conducted a systematic review of studies reporting use of the SentreHEART’s Lariat device in three or more patients. They identified the studies through searches of PubMed, EMBASE, CINAHL, and the Cochrane Library for the period January 2007 through August 2014, HealthDay News reports. They also examined the Food and Drug Administration’s MAUDE database for adverse events reports related to Lariat use.
The researchers found an overall success rate of 90 percent with the Lariat device in five reports of Lariat device use in 309 participants. 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. “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, according to lead researcher Jay Giri, MD, MPH, an assistant professor of cardiovascular medicine at the Perelman School of Medicine, University of Pennsylvania. Their 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.
Atrial fibrillation, which the Mayo Clinic describes as 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, a risk that has traditionally been managed with the drug warfarin, according to the study’s authors. But warfarin elevates the risk of bleeding, it requires regular monitoring of coagulation levels, and there is a high discontinuation rate among patients. Newer anticoagulants “circumvent some of these issues,” the authors write, but have also raised concerns about bleeding risk, cost, and the 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 authors write.
SentreHEART plans to seek FDA permission for clinical trials focused on the 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. In its statement, SentreHEART emphasized that the company does not promote, market, or advertise the device as a treatment for atrial fibrillation.