Off-label use resulted in cases where lifesaving surgery was needed or patient died
TUESDAY, May 5, 2015 (HealthDay News) — Heart surgeons are making regular, and potentially dangerous, off-label use of a suturing device in patients with atrial fibrillation, according to a report published online May 4 in JAMA Internal Medicine.
Researchers reviewed PubMed, EMBASE, CINAHL, and the Cochrane Library from January 2007 through August 2014 to identify all studies reporting use of the Lariat device in three or more patients. From five reports of Lariat device use in 309 participants, Lariat had an overall success rate of 90 percent. But the researchers said they also found seven cases of urgent need for cardiac surgery following use of the device, amounting to about 2 percent of the 309 procedures reviewed, and one death.
Formal analytic review of the FDA MAUDE (Manufacturer and User Facility Device Experience) database revealed five deaths and another 23 cases of urgent cardiac surgery resulting from the procedure, the study authors said. “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, M.D., M.P.H., told HealthDay. Giri is an assistant professor of cardiovascular medicine with the Perelman School of Medicine at the University of Pennsylvania in Philadelphia.
The manufacturer of the Lariat device, 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 study authors did not contact the company, and there is additional evidence that demonstrates the device’s safety. In its statement, SentreHEART emphasized that the company does not promote, market, or advertise the device as a treatment for atrial fibrillation.
Copyright © 2015 HealthDay. All rights reserved.