The Symptoms and Clinical events associated with Automatic Reprogramming (SCARE) at replacement notification study.

Area of Science:

• Cardiology
• Biomedical Engineering
• Medical Device Technology

Background:

• Pacemaker battery depletion triggers replacement alerts.
• Automatic reprogramming during replacement can lead to loss of crucial pacing functions like rate response and atrioventricular (AV) synchrony.

Purpose of the Study:

• To investigate the association between automatic pacemaker reprogramming at replacement notification and patient symptoms or clinical events.
• To quantify the incidence of adverse events related to reprogramming-induced loss of pacing features.

Main Methods:

• Retrospective review of electronic medical records for 266 patients undergoing pacemaker generator replacement.
• Categorization of patients into three reprogramming groups: no change, loss of rate response, and loss of AV synchrony (with or without rate response).
• Primary endpoints included patient-reported symptoms and documented clinical events during the replacement notification period.

Main Results:

• Over 31% of patients experienced symptoms, with significantly higher rates in those with loss of AV synchrony (62.1%) compared to loss of rate response (26.0%) or no change (4.3%).
• Over 10% of patients had clinical events, again with significantly higher rates in the loss of AV synchrony group (27.3%) versus loss of rate response (6.5%) and control (0.0%).
• Specifically, 27% of patients experiencing loss of AV synchrony required nonelective clinical care.

Conclusions:

• Automatic reprogramming during pacemaker replacement is associated with a substantial risk of symptoms and clinical events.
• Loss of atrioventricular (AV) synchrony presents a particularly high risk, with over half of affected patients experiencing symptoms and over a quarter requiring urgent clinical care.
• These findings highlight the need for careful management of pacemaker reprogramming to mitigate adverse patient outcomes.