Cautionary tale of right ventricular perforation during Micra™ leadless pacemaker insertion
Iosif Gulkarov1,2,3, Louis H Stein3, Ravindranath N Karanam3
1Department of Surgery RWJ Barnabas Health, Jersey City Medical Center Jersey City New Jersey USA.
Health Science Reports
|November 16, 2022
Summary
Leadless cardiac pacing systems offer advantages but carry risks. This report details two cases of major right ventricular perforation with transcatheter pacing systems requiring surgical intervention.
Area of Science:
- Cardiology
- Medical Devices
Background:
- Transcatheter pacing systems are leadless devices designed to avoid complications associated with traditional pacing systems.
- Pre-approval trials indicated a low incidence of device-related cardiac perforation for systems like Micra™ and Nanostim.
- Post-approval data for Micra™ TPS suggested even lower major complication rates.
Purpose of the Study:
- To report two cases of major right ventricular perforation requiring surgical intervention in patients implanted with transcatheter pacing systems.
- To highlight potential serious complications associated with leadless pacing technology.
Main Methods:
- Case report of two patients who experienced major right ventricular perforation after implantation of a transcatheter pacing system.
- Review of clinical presentation, diagnostic findings, and surgical management.
Main Results:
- Both patients developed major right ventricular perforation requiring emergent surgical repair.
- These cases contrast with previously reported lower complication rates in pre-approval and post-approval studies.
Conclusions:
- While transcatheter pacing systems offer benefits, major complications such as cardiac perforation can occur.
- These findings underscore the importance of vigilance and prompt management of suspected perforations in patients with these devices.
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