November 18, 2021 – The United States Food and Drug Administration (FDA) reminds providers of the risk of major complications from cardiac perforation when implanting a pacemaker without a lead. Heart perforation is a rare complication of any pacemaker system implant that can lead to major complications or even death.
The FDA said the overall risk of cardiac perforation associated with implantation of a leadless pacemaker appears similar to the risk associated with traditional transvenous pacing systems. However, the FDA said pre-market clinical studies of the Medtronic Micra leadless pacemaker suggested that major complications from cardiac perforation appeared to be more severe for patients who received a leadless pacing system compared to those who received a leadless pacemaker. patients who have received a transvenous pacemaker.
Information from actual use of the Micra suggests that cardiac perforations associated with Micra leadless pacemakers are more likely to be associated with serious complications, such as cardiac tamponade or death, than with pacemakers. traditional.
The FDA is working with the manufacturer to evaluate outcomes after cardiac perforation after implantation of leadless pacemaker systems to identify potential contributing factors and mitigation measures, and to ensure that the labeling of the product adequately solves the problem. The FDA will continue to monitor reports of adverse events and other postmarketing data sources associated with leadless pacemaker systems and will update the public if new or additional information becomes available.
The FDA is bringing this information to the attention of healthcare providers to remind them to report cardiac punctures and complications from a leadless pacemaker to the manufacturer and to the FDA. The agency is trying to figure out if there are more complications than what has been reported. The FDA said early notification of adverse events can help the agency and the manufacturer identify and better understand the risks associated with medical devices. The FDA is working with the manufacturer to assess information from all available sources, including post-market studies and real-world data, to provide additional information on this issue.
The FDA recommends that healthcare providers:
â¢ Discuss the risks and benefits of available pacemaker system options with patients as part of shared clinical decision making.
The benefit-risk profile of leadless pacing systems versus transvenous systems or alternative treatment options should be considered for each patient.
â¢ Be aware that although cardiac perforation is a rare complication after implantation procedures for a pacemaker system, the risk of major complications after cardiac perforation may be higher in patients receiving leadless pacemaker systems. compared to traditional transvenous pacemakers.
â¢ Implant physicians should be prepared for emergency management of patients with perforation when implanting a leadless pacemaker. In some cases, urgent cardiac surgery may be necessary.
â¢ Carefully read and follow the Instructions for Use (IFU) and training for the Medtronic Micra Transcatheter Leadless Pacing System, which includes recommendations on implant placement at the right ventricular septum, system direction. administration, device repositioning, patient selection to minimize the risk of perforation, availability pending cardiothoracic surgery and immediate access to echocardiography equipment.
â¢ Report any adverse events or suspected adverse events encountered with the Micra Transcatheter Pacing System or other pacemaker systems. Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Device manufacturers and user facilities must comply with applicable medical device reporting (MDR) regulations. Healthcare personnel employed by facilities subject to FDA user facility reporting requirements should follow the reporting procedures established by their facilities.
The Medtronic Micra Transcatheter Stimulation System was approved by the FDA in April 2016 with a mandatory post-approval study to provide more information and to help assess the continued safety and efficacy of the device. This pacemaker system does not require hard-wired wires to make an electrical connection between the pulse generator device and the heart. The Medtronic Micra is currently the only wireless pacemaker approved and marketed in the United States.
Pacemakers are surgically implanted medical devices that generate electrical pulses to treat slow heartbeats, and nearly one million people around the world have pacemakers implanted each year. The wire in a traditional single-chamber pacemaker extends from the pacemaker generator, which is implanted under the skin near the collarbone, through a vein, and ends in direct contact with the right ventricular wall of the heart. The lead delivers electrical pulses from the generator to the right ventricle and helps coordinate the heartbeat. While the Micra System and other leadless pacemakers work the same as pacemakers with leads to regulate heart rate, the one-inch-long, self-contained, leadless device is implanted directly into the right ventricular chamber of the heart. heart.
Cardiac perforation is a rare complication of any pacemaker system implant, occurring in about 1% of cases. Perforation usually occurs during implantation, but complications from a perforation can occur days, weeks, and even months after the implantation procedure. Heart perforation can lead to serious complications, including pericardial effusion (accumulation of fluid around the heart) requiring drainage with a catheter inserted through the skin (percutaneous drainage) or open surgical repair, overhaul of the pacemaker system, or the death. Pericardial drainage can be a life-saving emergency intervention in the event of a perforation.
Pre-marketing studies have reported that the rates of major puncture-related complications during the implantation of Micra leadless pacemakers were higher than in historically referenced studies. Postmarketing data supports these findings, namely that complication rates may be higher and events may be more serious (eg, leading to surgical repairs) for patients with leadless pacemakers. As of 2016, the FDA has received over 300 medical device reports (MDRs) for the Micra wireless pacemaker that describe perforation, and more than 90 of these describe perforation resulting in death.
The FDA recognizes the limitations of MDR data, and reports submitted to the FDA are only one source that the FDA uses to monitor and evaluate the safety and efficacy of medical devices, in addition to mandatory post-marketing studies, of published literature and real-world data from claims registries and databases. The FDA said it will continue to review data from the ongoing post-approval study and other available data sources as they become available.
Adherence to the instructions provided in the manufacturer’s product manual and user training can reduce the risk of cardiac injury, especially considerations relating to the direction of the delivery system, repositioning of the device and selection of the device. patient. Implant physicians must be prepared to deal with cardiac perforation on an emergency basis when implanting a pacemaker without a lead. In some cases, urgent cardiac surgery may be necessary. The FDA will continue to work with the manufacturer to ensure that healthcare providers are aware of the risk of major complications from a perforation of the heart when implanting a pacemaker without a lead.
Reporting Micra Problems to the FDA
The FDA encourages healthcare providers to report any adverse events or suspected adverse events encountered with the Micra Transcatheter Pacing System or other pacemaker systems.
â¢ Voluntary reports can be submitted via MedWatch, the FDA’s Safety Information and Adverse Event Reporting Program.
â¢ Device manufacturers and user facilities must comply with applicable M standards.medical regulations on device reporting (MDR).
â¢ Health personnel employed by establishments subject to the FDA User Facility Reporting Requirements should follow the reporting procedures established by their facilities.
Prompt notification of adverse events can help the FDA identify and better understand the risks associated with medical devices.