PREFER (Pacemaker Remote Follow-Up Evaluation and Review)

The Clinically Actionable Events (CAE) were identified based on their relation to other comorbidities that may increase the risk of a serious cardiac event. The defined events are: 1. Atrial Tachycardia/Atrial Fibrillation (AT/AF) episodes of greater than 48 hours defined as two consecutive days in which the device records at least 18 hours of AT/AF per day 2. Ventricular pacing that has increased by 30 percent (relative) since the last device interrogation 3. A sensed ventricular response of greater than 100 beats per minute (BPM) during atrial tachyarrhythmia for at least 20 percent of the time since the previous device interrogation 4. Runs of non-sustained ventricular tachycardia (NSVT) greater than 5 beats 5. New onset of AT/AF among patients with no history of AT/AF 6. Loss of atrial capture 7. Loss of ventricular capture 8. Increase in atrial pacing voltage threshold greater than 1 volt (V) 9. Increase in ventricular pacing voltage threshold greater than 1 volt (V) 10. \& 11. Significant change in atrial or ventricular lead impedance, defined as any of the following: 1. Less than 200 or greater than 2000 ohms (Ω) 2. Unstable lead impedance deemed to be clinically actionable 3. Greater than 50 percent change in lead impedance since last interrogation 12\. Elective Replacement Indicator (ERI)/Battery End of Life (EOL) indicators