JAMA Report Examines Risks of Using Suturing Device Off-LabelMay 7, 2015
A report published online May 4 in JAMA Internal Medicine found that the off-label use of a suturing device in patients with atrial fibrillation could be dangerous, HealthDay News reports. The report focused on the Lariat device, manufactured by SentreHEART.
Researchers gathered data from studies reporting use of the Lariat device in at least three patients between January 2007 and August 2014 using PubMed, EMBASE, CINAHL and the Cochrane Library. A 90 percent success rate was identified from five reports involving 309 participants. However, the study also found that patients needed urgent cardiac surgery following Lariat use in seven cases; this accounts for about 2 percent of all procedures reviewed. There was also one death.
The authors conducted a formal analytic review of the FDA MAUDE (Manufactured and User Facility Device Experience) database and identified another five deaths and an additional 23 cases of urgent cardiac surgery due to Lariat use. Lead researcher Jay Giri, MD, MPH, who is is an assistant professor of cardiovascular medicine with the Perelman School of Medicine at the University of Pennsylvania in Philadelphia, told HealthDay "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"
HealthDay reports that SentreHEART intends to seek FDA approval for clinical trials looking at this off-label use.