Should they stay, or should they go: Do we need to remove the old cardiac implantable electronic device if a new system is required on the contralateral side?

Background: Ipsilateral approach in patients requiring cardiac implantable electronic device (CIED) revision or upgrade may not be feasible, primarily due to vascular occlusion. If a new CIED is implanted on the contralateral side, a common practice is to explant the old CIED to avoid device interaction. Objective: The purpose of this study was to assess a conservative approach of abandoning the old CIED after implanting a new contralateral device. Methods: We used an artificial intelligence algorithm to analyze postimplant chest radiographs to identify those with multiple CIEDs. Outcomes of interest included device interaction, abandoned CIED elective replacement indicator (ERI) behavior, subsequent programming changes, and explant of abandoned CIED. Theoretical risk of infection with removal of abandoned CIED was estimated using a validated scoring system. Results: Among 12,045 patients, we identified 40 patients with multiple CIEDs. Occluded veins were the most common indication for contralateral implantation (n = 27 [67.5%]). Fifteen abandoned CIEDs reached ERI, with 4 reverting to VVI 65. One patient underwent explant due to device interaction, and 2 required device reprogramming. Of 32 patients with an implantable cardioverter-defibrillator, 8 (25%) had treated ventricular arrhythmia. There were no failed or inappropriate therapies due to interaction. Eighteen patients (45%) had hypothetical >1% annual risk of hospitalization for device infection if the abandoned CIED had been explanted. Conclusion: In patients requiring new CIED implant on the contralateral side, abandoning the old device is feasible. This approach may reduce the risk of infection and concerns regarding abandoned leads and magnetic resonance imaging scans. Knowledge of ERI behavior is essential to avoid device interactions.

Shortness of breath and palpitations in an elderly man: Bad device behavior or malfunction?

70-year-old male with sinus node dysfunction (SND) and paroxysmal atrial fibrillation presents with shortness of breath and palpitations. Presenting EKG shows AF with rapid ventricular rates requiring direct current cardioversion (DCCV). Post-DCCV EKG shows sinus rhythm with competing ventricular pacing. Device interrogation demonstrates the patient's generator at the elective replacement indicator (ERI) and has been forced to VVI 65 bpm causing dyssynchronous ventricular pacing and inducing AF. This case highlights the importance of close device follow up with timely PPM generator change prior to ERI, especially in patients with Medtronic Adapta devices, to avoid unnecessary dyssynchronous ventricular pacing. In addition, device manufacturers should focus on maintaining AV synchrony in pacemakers when they reach ERI.

Clinical implications of elective replacement indicator setting changes in patients with dual-chamber pacemaker devices.

OBJECTIVE: This study sought to determine if single-chamber operation and/or loss of rate response (RR) during elective replacement indicator (ERI) in patients with dual-chamber pacemakers lead to increased symptom burden, healthcare utilization, and atrial fibrillation (AF). BACKGROUND: Dual-chamber pacemakers often change from dual- to single-chamber pacing mode and/or lose RR functionality at ERI to preserve battery. Single-chamber pacing increases the incidence of heart failure, AF, and pacemaker syndrome suggesting these changes may be deleterious. METHODS: A retrospective analysis of 700 patients was completed. Three comparisons were analyzed: Comparison 1: mode change and RR loss versus no change; Comparison 2: RR loss only versus no change; Comparison 3: mode change only versus no change (in patients with no RR programmed at baseline). RESULTS: In Comparison 1, 121 (46%) patients with setting changes experienced symptoms (most often dyspnea and fatigue/exercise intolerance) versus 3 (4%) without setting changes (p < .0001). Similar results were noted in Comparisons 2 and 3 (p = .0016 and p = .0001, respectively). In Comparison 1, patients with setting change sought provider contact more than patients without setting changes (p = .0001). A significant difference was not noted in Comparison 2 or 3. Overall 14 (2%) patients were hospitalized, all of whom had setting changes. CONCLUSIONS: Setting changes at ERI including a change from dual- to single-chamber pacing and/or loss of RR results in a significantly increased symptom burden and increased healthcare utilization.

Appropriate Implantable Cardioverter-Defibrillator Therapies Delivered 5 Years After End of Service.

We present the case of a 57-year-old man with a primary prevention internal cardioverter-defibrillator for severe nonischemic cardiomyopathy. At the time of elective replacement indicator, systolic function had fully recovered, and his generator was not changed. Nearly 5 years post-elective replacement indicator he received appropriate internal cardioverter-defibrillator therapies during a myocardial infarction. (Level of Difficulty: Intermediate.).

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

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.

Premature Trigger of ERI in Medtronic EnRhythm Devices.

BACKGROUND: Medical technology has made significant advances over the last few decades with smaller and more dynamic pacemakers. However, technical failures leading to premature replacement is a cause of concern. We present a series of Medtronic EnRhythm devices that reached premature elective replacement indicator (ERI). METHODS: The database of Centre of Heart Rhythm Disorders was searched for EnRhythm device implantation from 2006 to 2011. Battery depletion <8.5 years was considered premature considering the projected average longevity to be 8.5-10.5 years. An unexpected premature ERI was defined when it was reached within 3 months of last normal check. Device follow-up was conducted every 3 months after advisory. RESULTS: A total of 88 EnRhythm pacemakers were implanted. Over a median follow-up of 6.2 years (range: 0.3-9.2), 39 (44.3%) EnRhythm devices reached premature ERI. In 11 (28%), ERI was not recognized and patients were being investigated for other causes of unsteadiness or dyspnea prior to device check. Notably, three (7%) patients had premature ERI < 3.5 years. Ten (25.6%) had sudden and unexpected premature ERI. While asynchronous pacing was observed, there were no cases of absence of pacing. CONCLUSIONS: The rate of premature ERI for EnRhythm devices was 44.3%, significantly higher than reported by the manufacturer. Of concern, a sizeable proportion occurred unexpectedly, warranting more frequent reviews and empirical replacement in some patients. With the experience of the EnRhythm, appropriate monitoring strategies are recommended for future advisories.