Clinical experience with an activity sensing pacemaker.
During clinical evaluation of the Medtronic Activitrax pacemaker in a worldwide multicenter study, implant and follow-up data were provided by 61 investigators on 222 patients. Pacing indications included two- and three-degree AV block in 149 and atrial arrhythmias in 174 patients; 16 patients received atrial pacing. Average and longest documented follow-up periods were 7.5 and 16 months respectively. Paired treadmill tests, one in Activity mode and one in VVI/AAI mode, were performed by 120 patients. At peak exercise, average heart rate was 95 bpm in VVI/AAI mode and 118 bpm in Activity mode (p less than 0.0001). Average exercise time was 9.4 minutes in VVI/AAI mode and 10.8 minutes in Activity mode (p less than 0.0001). In 54 patients who exclusively had paced rhythm during both treadmill tests, average heart rates and exercise times were 70 ppm and 8.1 minutes in VVI/AAI mode and 111 ppm and 10.3 minutes in Activity mode respectively (p less than 0.0001). 24-hour Holter recordings typically demonstrated pacing at or near basic rate during periods of rest and appropriate increase in pacing rate during daily activities. Patients had significantly fewer problems with physical effort in daily life during a week of Activity mode pacing than during a week of VVI/AAI mode pacing (p less than 0.05) as assessed from the symptom scores recorded by 62 patients in special diaries.
D002986:Clinical Trials as Topic; D004562:Electrocardiography; D005080:Exercise Test; D006339:Heart Rate; D006801:Humans; D010138:Pacemaker, Artificial; D005082:Physical Exertion; D011897:Random Allocation