Vorgehen bei Patienten mit Assurity®- und Endurity®-Schrittmachern: Empfehlungen des Nucleus der Arbeitsgruppe Elektrophysiologie und Rhythmologie (AGEP) der Deutschen Gesellschaft für Kardiologie

In a subset of patients with pacemaker models Assurity® and Endurity® (Abbott, Sylmar, California, USA; worldwide outside the USA approximately 83,000 devices), a mistake during production may have occurred resulting in insufficient adhesion between the pulse generator header and device housing which in turn may allow moisture to enter the header. This may cause loss of telemetry, switch to back-up mode, reduced battery longevity, or in worst case loss of pacing. Until June 2022, these malfunctions were reported for 128 devices worldwide (0.15%); no permanent harm to patients due to this issue has been reported. The nucleus of the AGEP suggests the following recommendations: (1) Patients with a device under safety advisory should be informed. (2) The risks for the patient in case of loss of stimulation should be assessed. Patients should be categorized into “likely pacemaker-dependent” (e.g., indication permanent atrioventricular [AV] block, no intrinsic rhythm at the last follow-up, percentage of ventricular pacing in the device memory > 90%), “unknown”, or “likely not pacemaker-dependent” (e.g., indication sick sinus syndrome, intrinsic rhythm > 50 bpm at the last follow-up, percentage of ventricular pacing in the device memory < 1%). (3) In likely pacemaker-non-dependent patients, information about this issue should be provided together with an unchanged follow-up or a follow-up with shortened intervals (e.g., every 3 months) and/or remote monitoring. (4) In patients with unknown risk if stimulation failure occurs, at least follow-up intervals should be shortened to, for example, 3 months and/or remote monitoring should be initialized. In addition, risks and benefits of a device exchange should be weighed against each other. (5) In patients who are likely pacemaker-dependent, device exchange is recommended.