Implementation of remote follow-up of cardiac implantable electronic devices in clinical practice: organizational implications and resource consumption

Abstract Aims Cardiac implantable electronic devices with device advisories have the potential of device malfunction. Remote monitoring (RM) of devices has been suggested to allow the identification of abnormal device performance and permit early intervention. We sought to describe the outcomes of patients with and without RM in devices subject to the Abbott Premature Battery Depletion (PBD) advisory with data from a Canadian registry. Methods and results Patients with an Abbott device subject to the PBD advisory from nine implantable cardioverter defibrillator (ICD) implanting centres in Canada were included in the registry. The use of RM was identified from baseline and follow-up data in the registry. The primary outcome was detection of PBD and all-cause mortality. A total of 2666 patients were identified with a device subject to the advisory. In all, 1687 patients (63.2%) had RM at baseline. There were 487 deaths during follow-up. At a mean follow-up of 5.7 ± 0.7 years, mortality was higher in those without a remote monitor compared with RM at baseline (24.7% vs. 14.5%; P < 0.001). Pre-mature battery depletion was identified in 36 patients (2.1%) with RM vs. 7 (0.7%) without RM (P = 0.004). Time to battery replacement was significantly reduced in patients on RM (median 5 vs. 13 days, P = 0.001). Conclusion The use of RM in patients with ICD and cardiac resynchronization therapy under advisory improved detection of PBD, time to device replacement, and was associated with a reduction in all-cause mortality. The factors influencing the association with mortality are unknown and deserve further study.

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Follow-Up of Cardiac Implantable Electronic Devices—Remote Monitoring and in Person

Clinical Cardiac Pacing, Defibrillation and Resynchronization Therapy ◽

10.1016/b978-0-323-37804-8.00040-7 ◽

2017 ◽

pp. 1133-1157

Author(s):

Niraj Varma ◽

Renato Pietro Ricci

Keyword(s):

Remote Monitoring ◽

Electronic Devices ◽

Cardiac Implantable Electronic Devices

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Consensus statement for implantation and follow-up of cardiac implantable electronic devices in India

Indian Pacing and Electrophysiology Journal ◽

10.1016/j.ipej.2018.10.006 ◽

2018 ◽

Vol 18 (6) ◽

pp. 188-192

Author(s):

Shomu Bohora ◽

Amit Vora ◽

Aditya Kapoor ◽

Vanita Arora ◽

Nitish Naik ◽

...

Keyword(s):

Consensus Statement ◽

Electronic Devices ◽

Cardiac Implantable Electronic Devices

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Results of remote follow-up and monitoring in young patients with cardiac implantable electronic devices

Cardiology in the Young ◽

10.1017/s1047951114002613 ◽

2015 ◽

Vol 26 (1) ◽

pp. 53-60 ◽

Cited By ~ 2

Author(s):

Massimo S. Silvetti ◽

Fabio A. Saputo ◽

Rosalinda Palmieri ◽

Silvia Placidi ◽

Lorenzo Santucci ◽

...

Keyword(s):

Remote Monitoring ◽

Heart Defects ◽

Electronic Devices ◽

Young Patients ◽

Implantable Cardioverter Defibrillators ◽

Wireless Devices ◽

Cardiac Implantable Electronic Devices ◽

System Inclusion ◽

To Receive

AbstractBackgroundRemote monitoring is increasingly used in the follow-up of patients with cardiac implantable electronic devices. Data on paediatric populations are still lacking. The aim of our study was to follow-up young patients both in-hospital and remotely to enhance device surveillance.MethodsThis is an observational registry collecting data on consecutive patients followed-up with the CareLink system. Inclusion criteria were a Medtronic device implanted and patient’s willingness to receive CareLink. Patients were stratified according to age and presence of congenital/structural heart defects (CHD).ResultsA total of 221 patients with a device – 200 pacemakers, 19 implantable cardioverter defibrillators, and two loop recorders – were enrolled (median age of 17 years, range 1–40); 58% of patients were younger than 18 years of age and 73% had CHD. During a follow-up of 12 months (range 4–18), 1361 transmissions (8.9% unscheduled) were reviewed by technicians. Time for review was 6±2 minutes (mean±standard deviation). Missed transmissions were 10.1%. Events were documented in 45% of transmissions, with 2.7% yellow alerts and 0.6% red alerts sent by wireless devices. No significant differences were found in transmission results according to age or presence of CHD. Physicians reviewed 6.3% of transmissions, 29 patients were contacted by phone, and 12 patients underwent unscheduled in-hospital visits. The event recognition with remote monitoring occurred 76 days (range 16–150) earlier than the next scheduled in-office follow-up.ConclusionsRemote follow-up/monitoring with the CareLink system is useful to enhance device surveillance in young patients. The majority of events were not clinically relevant, and the remaining led to timely management of problems.

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Subclinical Atrial Fibrillation and Risk of Stroke: Past, Present and Future

Medicina ◽

10.3390/medicina55100611 ◽

2019 ◽

Vol 55 (10) ◽

pp. 611 ◽

Cited By ~ 3

Author(s):

AlTurki ◽

Marafi ◽

Russo ◽

Proietti ◽

Essebag

Keyword(s):

Atrial Fibrillation ◽

Clinical Practice ◽

Electronic Devices ◽

High Rate ◽

Cardiac Monitoring ◽

Stroke Event ◽

Cardiac Implantable Electronic Devices ◽

Increased Risk ◽

History Of ◽

New Evidence

Subclinical atrial fibrillation (SCAF) describes asymptomatic episodes of atrial fibrillation (AF) that are detected by cardiac implantable electronic devices (CIED). The increased utilization of CIEDs renders our understanding of SCAF important to clinical practice. Furthermore, 20% of AF present initially as a stroke event and prolonged cardiac monitoring of stroke patients is likely to uncover a significant prevalence of SCAF. New evidence has shown that implanting cardiac monitors into patients with no history of atrial fibrillation but with risk factors for stroke will yield an incidence of SCAF approaching 30–40% at around three years. Atrial high rate episodes lasting longer than five minutes are likely to represent SCAF. SCAF has been associated with an increased risk of stroke that is particularly significant when episodes of SCAF are greater than 23 hours in duration. Longer episodes of SCAF are incrementally more likely to progress to episodes of SCAF >23 hours as time progresses. While only around 30–40% of SCAF events are temporally related to stroke events, the presence of SCAF likely represents an important risk marker for stroke. Ongoing trials of anticoagulation in patients with SCAF durations less than 24 hours will inform clinical practice and are highly anticipated. Further studies are needed to clarify the association between SCAF and clinical outcomes as well as the factors that modify this association.

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P1182Asymptomatic masses on the pacing leads - influence on long term survival

EP Europace ◽

10.1093/europace/euaa162.132 ◽

2020 ◽

Vol 22 (Supplement_1) ◽

Author(s):

A Polewczyk ◽

D Nowosielecka ◽

A Tomaszewski ◽

W Brzozowski ◽

D Szczesniak-Stanczyk ◽

...

Keyword(s):

Connective Tissue ◽

Clinical Significance ◽

Electronic Devices ◽

Single Center ◽

Term Survival ◽

Long Term Survival ◽

Cardiac Implantable Electronic Devices ◽

Pacing Leads

Abstract Background Asymptomatic Masses on Endocardiac Leads (AMELs) are relatively often found in echocardiography in patients with cardiac implantable electronic devices (CIED) but their clinical significance is unknown. Purpose Aim of the study was to evaluate the incidence of AMELs and assesment of their influence on long term survival (mean follow up- 4,28 ± 3,13 years) of patients undergoing transvenous leads extraction (TLE). Methods We analyzed the clinical data of patients undergoing TLE in single center in years 2006-2019. Echocardiography before TLE was performed in 2558 patients (60,4% male). AMELs were detected in 426 (16,7%) cases. Classifications of AMELs included connective tissue surronding the leads, clots, alike vegetations masses. Additionally, real vegetations, thickening of the leads and strong connective tissue scars were distinguished. Long term survival was compared between individual types of AMELs and patients without any additional masses on the leads. Results are presented in the table. Conclusion Poor long-term survival was observed in patients with AMELs on the pacing leads. Abstract Table

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444 Epidemiology of subclinical atrial fibrillation in patients with cardiac implantable electronic devices: a systematic review and meta-regression

European Heart Journal Supplements ◽

10.1093/eurheartj/suab127.002 ◽

2021 ◽

Vol 23 (Supplement_G) ◽

Author(s):

Marco Borgi ◽

Marco Proietti ◽

Giulio Francesco Romiti ◽

Marco Vitolo ◽

Arianna Di Rocco ◽

...

Keyword(s):

Atrial Fibrillation ◽

Systematic Review ◽

Regression Analysis ◽

Electronic Devices ◽

Older Age ◽

Cardiac Implantable Electronic Devices ◽

History Of ◽

Meta Regression ◽

Meta Regression Analysis

Abstract Aims In recent years, attention to subclinical atrial fibrillation (SCAF), defined as the presence of atrial high-rate episodes (AHREs), in patients with cardiac implantable electronic devices (CIEDs), has gained much interest as a determinant of clinical AF and stroke risk. To perform a systematic review and meta-regression of the available scientific evidence regarding the epidemiology of SCAF in patients receiving CIEDs. Methods and results PubMed and EMBASE were searched for all studies documenting the incidence of AHREs in patients (n = 100 or more) with CIEDs without any previous history of AF from inception to 20 August 2021, screened by two independent blind reviewers. This study was registered in PROSPERO: CRD42019106994. Among the 2614 results initially retrieved, 54 studies were included, with a total of 72 784 patients. Meta-analysis of included studies showed a pooled prevalence of SCAF of 28.1%, with an incidence rate (IR) of 16 new SCAF cases per 100 patient-years (I2 = 100%). Multivariate meta-regression analysis showed that age and follow-up time were the only significant determinants of IR, explaining a large part of the heterogeneity (R2 = 61.5%, P < 0.001), with higher IR at earlier follow-up and in older patients, decreasing over follow-up time and increasing according to mean age. Older age, higher CHA2DS2-VASc score, history of AF, hypertension, CHF, and stroke/TIA were all associated with SCAF occurrence. Conclusions In this systematic review and meta-regression analysis, IR of SCAF increased with age and decreased over longer follow-up times. SCAF was associated with older age, higher thromboembolic risk, and several cardiovascular comorbidities.

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Incidence and Predictors of Infections and All-Cause Death in Patients with Cardiac Implantable Electronic Devices: The Italian Nationwide RI-AIAC Registry

Journal of Personalized Medicine ◽

10.3390/jpm12010091 ◽

2022 ◽

Vol 12 (1) ◽

pp. 91

Author(s):

Giuseppe Boriani ◽

Marco Proietti ◽

Matteo Bertini ◽

Igor Diemberger ◽

Pietro Palmisano ◽

...

Keyword(s):

Patient Outcomes ◽

Clinical Status ◽

Electronic Devices ◽

Clinical Event ◽

Clinical Factors ◽

Factors Associated ◽

Cardiac Implantable Electronic Devices ◽

Clinical Events ◽

Event Score

Background: The incidence of infections associated with cardiac implantable electronic devices (CIEDs) and patient outcomes are not fully known. Aim: To provide a contemporary assessment of the risk of CIEDs infection and associated clinical outcomes. Methods: In Italy, 18 centres enrolled all consecutive patients undergoing a CIED procedure and entered a 12-months follow-up. CIED infections, as well as a composite clinical event of infection or all-cause death were recorded. Results: A total of 2675 patients (64.3% male, age 78 (70–84)) were enrolled. During follow up 28 (1.1%) CIED infections and 132 (5%) deaths, with 152 (5.7%) composite clinical events were observed. At a multivariate analysis, the type of procedure (revision/upgrading/reimplantation) (OR: 4.08, 95% CI: 1.38–12.08) and diabetes (OR: 2.22, 95% CI: 1.02–4.84) were found as main clinical factors associated to CIED infection. Both the PADIT score and the RI-AIAC Infection score were significantly associated with CIED infections, with the RI-AIAC infection score showing the strongest association (OR: 2.38, 95% CI: 1.60–3.55 for each point), with a c-index = 0.64 (0.52–0.75), p = 0.015. Regarding the occurrence of composite clinical events, the Kolek score, the Shariff score and the RI-AIAC Event score all predicted the outcome, with an AUC for the RI-AIAC Event score equal to 0.67 (0.63−0.71) p < 0.001. Conclusions: In this Italian nationwide cohort of patients, while the incidence of CIED infections was substantially low, the rate of the composite clinical outcome of infection or all-cause death was quite high and associated with several clinical factors depicting a more impaired clinical status.

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P6546Canadian Registry of Electronic Device Outcomes (CREDO): remote monitoring outcomes in the abbott battery performance alert, a multicentre cohort

European Heart Journal ◽

10.1093/eurheartj/ehz746.1136 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

S Davis ◽

B Thibault ◽

I Mangat ◽

B Coutu ◽

M Bennett ◽

...

Keyword(s):

Remote Monitoring ◽

Primary Outcome ◽

Electronic Device ◽

Electronic Devices ◽

Device Performance ◽

Remote Monitor ◽

Cardiac Implantable Electronic Devices ◽

All Cause Mortality ◽

Multicentre Cohort

Abstract Background Cardiac implantable electronic devices have been known to have lead and device malfunctions leading to advisories. Increased use of remote monitoring of devices has been suggested to allow the identification of abnormal device performance and allow early intervention. We sought to describe the outcomes of patients with and without remote monitoring of in devices in the Abbott Premature Battery Depletion advisory with data from a Canadian registry Methods Patients with an Abbott device subject to the Battery Performance Alert Advisory from nine ICD implanting centres in Canada were included in the registry. The use of remote monitoring was identified from baseline and followup data in the registry. The primary outcome was detection of premature battery depletion and all cause mortality. Results 2679 patents were identified with a device subject to the advisory. Devices were implanted between 2010 and 2017. 1716 patients (64%) had remote monitoring at baseline with this increasing to 83.7% at followup at 12 months. Premature battery depletion occurred in 43 patients (1.6%). Discovery of premature battery depletion was detected by remote monitoring in 70% of patients. There were 492 deaths during the follow up. Mortality was higher in those without a remote monitor compared to those with a remote monitor at follow-up and remote monitor at baseline and follow-up (11.3%, 2.6% versus 6.1% respectively; p=0.0186). There were no deaths attributed to premature battery depletion Conclusion The use of remote monitoring in patients with ICD and CRT under advisory reliably detected device failure and was associated with a reduction in all-cause mortality.

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