Safety and Effectiveness of Leadless VR Pacing Systems: A Comparative Analysis of Major Complications from the MAUDE Database

Background: Leadless pacemakers (LPs) have emerged as a well-recognized alternative to traditional transvenous permanent pacemakers (TV-IPGs) for managing bradyarrhythmia. Initial data from the Medtronic Micra VR (MM) and the Abbott Aveir VR (AA) transcatheter pacing system (TPS) investigational device exemption (IDE) studies demonstrated high implantation success rates and lower complication rates compared to historical TV-IPG patients. A preliminary comparative study of 25 patients with AA and a matched control group of earlier implanted MM showed similar effectiveness and safety profiles.

Objective: This comparative study aimed to investigate the incidence of three main complications (death, injury, and malfunction) and six specific complications (cardiac perforation, dislocation, stimulation failure, sensing failure, elevated stimulation threshold, and extended helix) associated with the two commercially available leadless pacemakers, AA (LSP112V) and MM (MC1VR01), using data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database.

Methods: We conducted a search of the FDA MAUDE database for the first 18 months following the FDA approval of both devices to obtain comparable data. Data for MM was collected from July 1, 2016, to December 31, 2017, and for AA from July 1, 2022, to December 31, 2023. The number of implanted devices during these periods was extrapolated from registered US implant numbers reported in the Product Performance Reports of both manufacturers.

Device Micra-VR (MC1VR01) Aveir-VR (LSP112V) P-value Number of Implanted Devices (PPR) 12.459 4.644 - Overall Registered Complaints (MAUDE) 153 (1.23%) 313 (6.74%) <.001 Death (device related) 2 (0.02%) 10 (0.22%) <.001 Injury 79 (0.63%) 69 (1.49%) <.001 Malfunctions 65 (0.52%) 230 (4.95%) <.001 Not Clearly Specified 7 4 - Specific Complications Cardiac Perforation 17 (0.14%) 18 (0.39%) .002 Dislodgement 9 (0.07%) 42 (0.90%) <.001 Failure to Capture 30 (0.24%) 27 (0.58%) .001 Failure to Sense 8 (0.06%) 7 (0.15%) .14 High Capture Threshold 21 (0.17%) - <.001 Extended Helix - 21 (0.45%) <.001

 Table 1: Comparison of complication rates between AA and MM leadless VR devices and statistical analysis

Conclusions: The results of this comparative evaluation of commercially available single-chamber leadless pacing systems using the MAUDE database confirm the safety and effectiveness of both systems, as indicated by the low rates of reported complications. Although MM showed a lower reporting rate for the three main complications and five of the six specific complications compared to AA, the data suggest that both devices maintain safety and effectiveness over the long term. This conclusion is supported by recent data from the Micra 5-year post-approval registry, which indicates that most major complications with MM occur within 30 days post-implant and remain as low as 4.5% through five years.