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Leadless pacemaker perforations: Clinical consequences and related device and user problems.

Robert G Hauser1, Charles C Gornick1, Raed H Abdelhadi1

  • 1Heart Rhythm Science Center, Minneapolis Heart Institute Foundation, Minneapolis, Minnesota, USA.

Journal of Cardiovascular Electrophysiology
|December 25, 2021
PubMed
Summary
This summary is machine-generated.

Leadless pacemaker perforations, like the Micra device, can lead to death and serious complications. Device or operator issues contribute to at least half of these cardiac perforations, necessitating further study.

Keywords:
complicationleadlesspacemakerperforationpericardial effusiontamponade

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Area of Science:

  • Cardiology
  • Medical Device Safety

Background:

  • Cardiac perforation is a risk during leadless pacemaker implantation.
  • Perforations from leadless pacemakers may require more intervention than transvenous lead perforations.

Purpose of the Study:

  • To report the consequences of Micra pacemaker perforations.
  • To identify device and operator use problems associated with Micra perforations.

Main Methods:

  • Searched the FDA's Manufacturer and User Facility Device Experience (MAUDE) database for Micra perforations.
  • Extracted data on deaths, major adverse clinical events (MACEs), and device/operator use problems.

Main Results:

  • Between 2016-2021, 563 Micra perforations were reported, with 27% resulting in death and 89% causing cardiac tamponade.
  • Half of perforations were linked to device (25%) or operator (14%) issues, or both (11%).
  • Even without identified device/operator problems, 50% of perforations led to death, tamponade, or emergency surgery.

Conclusions:

  • Micra pacemaker perforations reported in MAUDE are frequently linked to mortality and severe complications.
  • Device and usage problems account for at least half of these perforations.
  • Further research is needed to identify at-risk patients and prevent major adverse clinical events.