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

ABSTRACT:

Background

Cardiac perforation during leadless pacemaker implantation is more likely to require intervention than perforation by a transvenous lead. This study reports the consequences of Micra pacemaker perforations and related device and operator use problems based on information the manufacturer has submitted to the Food and Drug Administration (FDA).

Methods

FDA's Manufacturer and User Facility Device Experience (MAUDE) database was searched for Micra perforations. Data extracted included deaths, major adverse clinical events (MACEs), and device and/or operator use problems.

Results

Between 2016 and July 2021, 563 perforations were reported within 30 days of implant and resulted in 150 deaths (27%), 499 cardiac tamponades (89%), 64 pericardial effusions (11%), and

SUBMITTER: Hauser RG 

PROVIDER: S-EPMC9305184 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature