An Early Look at a New Leadless Pacemaker
Robert G. Hauser MD
The Joseph F. Novogratz Family Heart Rhythm Science Center, Minneapolis
Heart Institute Foundation, 920 East 28th Street, Minneapolis, MN 55407,
USA
The Aveir leadless pacemaker (LP) (Abbott, USA) received Food and Drug
Administration (FDA) approval in April 2022 after a successful LEADLESS
II-Phase 2 clinical trial.1 A month later, in early
May 2022, the manufacturer submitted its first Aveir medical device
report (MDR) to the FDA describing an adverse clinical event. Such
reporting is mandatory when a marketed device may have caused or
contributed to a death or serious injury or malfunctioned. The reports
are stored in the FDA’s Manufacturer and User Facility Device Experience
(MAUDE) database, and they are freely available and searchable online at
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm.
Physicians and researchers often query MAUDE to assess medical device
performance issues that have not been announced or published and yet are
important because they may impact patient safety. A MAUDE report lists
the device and patient problems, the date of the event, and a narrative
description of the event. If available, the results of returned product
analyses are also detailed. The denominator (number of devices exposed)
is not provided, and thus the incidence of a given problem cannot be
calculated unless the number is available from the manufacturer or
another credible source such as a device registry. MAUDE does not
provide patient demographic or clinical information, and not all adverse
events are reported to the FDA , especially those occurring outside the
United States. Despite these limitations, MAUDE is a useful surveillance
tool for identifying serious product problems that may be unappreciated
or otherwise unrecognized by the medical community. Importantly, MAUDE
often reflects product deficiencies that are emerge only after a device
is introduced into the ”real-world” of widespread clinical
use.2
In this issue of the Journal , Garg et al3describe the results of their analysis of 64 Aveir LP MDRs they found in
MAUDE in January 2023. These included reports received by the FDA during
the 8 months from May-December 2022; excluded were 34 MDRs that were
duplicate reports or related to the programmer or introducer. They found
8 major adverse events, including 2 perforation-related deaths, 3
pericardial effusions requiring pericardiocentesis, and 3 patients who
had sustained ventricular tachycardia. Ostensibly these events were
procedural complications rather than device-specific issues.
The device-specific problems included 9 device separation failures,
whereby the pacemaker could not be released from the delivery system;
all of them were removed and a new system reintroduced. Some of the
removed devices exhibited tether fragmentation; the tethers maintain
contact with the Aveir LP when it is undocked from the delivery catheter
during threshold testing. In 5 cases, the active fixation helix became
distorted and required LP replacement. Altogether, of 64 initial implant
attempts, 27 Aveir LPs (42.2%) were not implanted and required
replacement with another pacemaker. In addition, there were a number of
electrode-tissue deficiencies manifested by high threshold, low sensing,
or abnormal impedance.
This brief report highlights several product performance issues that
will require close monitoring. Perforation and pericardial effusion are
complications shared by all implantable intracardiac electrophysiology
devices, and they occur more frequently when a device has to be
repositioned or exchanged. Why the Aveir LPs suffered separation
failures and damaged helices are important questions for the
manufacturer to answer and resolve. Otherwise, potentially harmful LP
exchanges will continue to occur. \