Evaluation of autosensing as an automatic means of maintaining a 2:1 sensing safety margin in an implanted pacemaker. Autosensing Investigation Team.
As intracardiac signal amplitudes fluctuate due to patient activity, drug intake, and other factors, it is imperative that an adequate sensing safety margin in an implanted pacemaker be used to compensate. We studied an investigational autosensing feature that automatically adjusts the device's sensitivity. Data were collected from 55 patients, with Intermedics model 292-03 or 294-03 pacemakers, upon inclusion of the study (Visit 1); 1 month postinclusion (Visit 2); 1 month, 1 day postinclusion (Visit 3); then 1 month, 2 days postinclusion (Visit 4). Atrial (N = 45) and/or ventricular (N = 54) thresholds were assessed at each visit; during Visit 2, myopotential tests were performed at two sensitivity settings. Autosensing was activated following Visit 1, then programmed on randomly at Visit 2 or Visit 3. From Visit 2-Visit 4, patients were monitored during daily activities (D), exercise (E), and sleep (S) with 24-hour Holter. With Autosensing on, atrial undersensing episodes were D = 33 (P > 0.2), and S = 28 (p < 0.05); ventricular undersensing episodes were D = 6 (p > 0.5). Ventricular oversensing episodes were S = 2; atrial oversensing episodes were S = 34 (p > 0.5), D = 2, and E = 3. Comparing Autosensing adjusted sensitivity with the recommended 2:1 safety margin, 4 patients (p = 0.15) experienced atrial myopotential oversensing, and 2 patients (p = 0.15) ventricular. No unanticipated clinical events occurred. Compared with the recommended 2:1 sensing safety margin, the Autosensing feature performed equal to manual programming in preventing episodes of under/oversensing, and was better for atrial undersensing during sleep. Autosensing obviates the need for periodic reprogramming of a fixed sensitivity value.
Castro
A
A
Hospital General, Jerez, Spain.
Liebold
A
A
Vincente
J
J
Dungan
T
T
Allen
J C
JC
D000200:Action Potentials; D000203:Activities of Daily Living; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016275:Atrial Function; D001331:Automation; D002304:Cardiac Pacing, Artificial; D018592:Cross-Over Studies; D004311:Double-Blind Method; D015716:Electrocardiography, Ambulatory; D004867:Equipment Design; D004868:Equipment Failure; D004869:Equipment Safety; D005069:Evaluation Studies as Topic; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010138:Pacemaker, Artificial; D005082:Physical Exertion / Q000502:physiology; D012890:Sleep / Q000502:physiology; D016276:Ventricular Function