Electrocardiographic predictors of pacemaker battery depletion: Diagnostic sensitivity, specificity, and clinical risk

Abstract

Background: Pacemaker battery depletion triggers alert for replacement notification and results in automatic reprogramming, which has been shown to be associated with relevant cardiorespiratory symptoms and adverse clinical events.Objective: Determine if electrocardiogram (ECG) pacing features may be predictive of pacemaker battery depletion and clinical risk.Methods: This is an ECG substudy of a cohort analysis of 298 subjects referred for pacemaker generator replacement from 2006 to 2017. Electronic medical record review was performed; clinical, ECG, and pacemaker characteristics were abstracted. We applied two ECG prediction rules for pacemaker battery depletion that are relevant to all major pacemaker manufacturers except Boston Scientific and MicroPort: (1) atrial pacing not at a multiple of 10 and (2) nonsynchronous ventricular pacing not at a multiple of 10, to determine diagnostic sensitivity, specificity, and risk in applicable ECG subjects. Results:We excluded 32 subjects not at replacement notification or duplicate surgeries. Overall, 176 of 266 subjects (66.2%) demonstrated atrial pacing or nonsynchronous ventricular pacing on preoperative ECG. When utilizing both rules, 139 of 176 preoperative ECGs and 12 of 163 postoperative ECGs met criteria for battery depletion yielding reasonable sensitivity (79.0%), high specificity (92.6%), and a positive likelihood ratio of 11.6:1. These rules were associated with significant increase in cardiorespiratory symptoms (P < .001) and adverse clinical events (P < .025). Conclusions:The "Rules of Ten" provided reasonable sensitivity and specificity for detecting replacement notification in pacemaker subjects with an applicable ECG. This ECG tool may help clinicians identify most patients with pacemaker battery depletion at significant clinical risk.

Electrocardiographic characteristics in detecting pacemaker battery depletion

“…Another limitation with the use of the ECG predictors is with patients without pacing or with synchronous AV pacing. However, the clinical impact of automatic reprogramming in this subset of patients was observed to be minimal . Parsonnet and Cheema reported that most patients do not outlive their pacemakers .…”

“…When pacemaker batteries are depleted, different pacemaker manufacturers installed automatic reprogramming features to extend battery life before replacement. Reprogramming of the rate response, AV synchrony, and lower rate limit may occur depending on the device manufacturer . Adverse events have been reported to be associated with the need for battery replacement.…”

“…Most manufacturers decrease the lower rate limit when reprogramming occurs . When Abbot's, Biotronik's, and Medtronic's pacemakers are automatically reprogrammed, the lower rate decreases by 10%, 11%, and to 65 bpm, respectively . Hence, the new pacing rate is no longer a multiple of 10 in patients with one of these brands installed, having reached battery depletion requiring automatic reprogramming.…”

“…The “Rule of Ten” does not work with a manufacturer whose replacement notification does not alter pacing mode or lower pacing rate (Boston Scientific), a manufacturer whose automatic reprogramming results in a lower pacing rate that is a multiple of 10 (MicroPort, formerly LivaNova, Shanghai, China—where the lower rate limit is set to 70, a multiple of 10), and specific models of other manufacturers known to not utilize the automatic reprogramming feature, such as Medtronic AT 501 dual‐chamber pacemaker. Conversely, the “Rule of Ten” would provide high sensitivity and specificity in a study population with a preponderance of pacemakers manufactured by Abbott, Biotronik, or Medtronic in which automatic reprogramming of the lower pacing rate to a rate not a multiple of 10 is expected following replacement notification . The proposed ECG predictors are capable of informing the nonspecialized physician about patient's battery status, a feature that puts the patient at an increased risk of adverse events and cardiorespiratory symptoms.…”

“…The resulting sensitivity was 79.0%, and the specificity was 92.6%. The false‐positive rate was due to activation of rate responsive programming . The proposed ECG predictors do not not take into account the knowledge the physician may have about the pacemaker.…”