Leadless pacemakers may put patients at an elevated risk of major complications, including death, due to cardiac perforation, according to a new letter published by the FDA. All pacemakers are associated with a risk of cardiac perforation, the agency said, but perforation-related complications appear to be more severe with leadless pacing systems than transvenous pacemakers.
Just one FDA-approved leadless pacemaker is currently on the market—Medtronic’s Micra, which gained agency approval in April 2016. The FDA said it has received more than 300 reports of Micra-related cardiac perforation since 2016, and more than 90 of those patients died from perforation-related complications.
“Following the instructions provided in the manufacturer’s product manual and user training can reduce the risk of cardiac injury, especially considerations for delivery system steering, repositioning the device, and patient selection,” the agency wrote. “Implanting physicians should be prepared to emergently manage cardiac perforation during leadless pacemaker implantation. In some cases, urgent cardiac surgical intervention may be necessary. The FDA will continue to work with the manufacturer to ensure that health care providers are aware of the risk of major complications if cardiac perforation occurs during leadless pacemaker implantation.”
The FDA also emphasized that healthcare providers should discuss the risks and benefits of all available pacemaker options with patients before a final treatment decision has been made.
The full FDA letter can be read here.