Publications by authors named "Melanie Kapphahn-Bergs"
A comparison of procedure-related adverse events between two right ventricular leadless pacemakers.
J Cardiovasc Electrophysiol
December 2024
Article Synopsis
- - The study compares the safety and device-related issues of two leadless pacemakers in the U.S.: Medtronic Micra VR and Abbott AVEIR VR, focusing on major adverse clinical events (MACE) and device problems during 2022-2024.
- - Approximately 6,000 AVEIR VR and 10,000 Micra VR implants were registered, with similar rates of MACE and serious procedural complications between the two, indicating comparable safety profiles.
- - Despite similar safety outcomes, Micra VR had more cases requiring replacement due to unacceptable thresholds, while AVEIR VR experienced more significant device dislodgements, suggesting design-related differences.
Article Synopsis
- * Researchers analyzed data from the FDA's MAUDE database from 2019-2023, identifying 854 reports involving deaths, injuries, and malfunctions related to normally functioning ICDs.
- * The most frequent reasons for these failures included misclassification of VT as other conditions (like SVT or AF) and undersensing issues, with undersensing linked to a significant portion of deaths, highlighting the need for further investigation and solutions.
Background: In 2022 and 2023, Medtronic recalled implantable defibrillators because they may deliver less than full-energy shocks. The 2022 problem truncates the second phase of the waveform (SCP-T2), resulting in ∼32-J shocks, and is mitigated by downloadable software. The 2023 malfunction truncates the first phase of the waveform, resulting in 0- to 12-J shocks due to a glassed feedthrough problem (GFT-T1) that might be avoided by programming B>AX shock polarity.
View Article and Find Full Text PDFLeadless pacemaker perforations: Clinical consequences and related device and user problems.
J Cardiovasc Electrophysiol
February 2022
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.