Automatic Remote Monitoring of Implantable Cardiac Devices in Clinical Practice – The Lumos-T Safely Reduces Routine Office Device Follow-up (TRUST) Trial

2010 ◽  
Vol 6 (3) ◽  
pp. 87
Author(s):  
Niraj Varma ◽  

The use of implantable electronic cardiac devices is increasing. Post-implantation follow-up is important for monitoring both device function and patient condition; however, clinical practice is inconsistent. For example, implantable cardioverter–defibrillator follow-up schedules vary from every three months to yearly according to facility and physician preference and the availability of resources. Importantly, no surveillance occurs between follow-up visits. By contrast, implantable devices with automatic remote monitoring capability provide a means for performing constant surveillance, with the ability to identify salient problems rapidly. The Lumos-T Reduces Routine Office Device Follow-up Study (TRUST) demonstrated that remote home monitoring reduced clinic burden and allowed early detection of patient and/or system problems, enabling efficient monitoring and an opportunity to enhance patient safety. The results of the trial have significant implications for the management of patients receiving all forms of implantable electronic cardiac device.

2019 ◽  
Vol 26 (9) ◽  
pp. 920-927 ◽  
Author(s):  
Giovanni Q Villani ◽  
Andrea Villani ◽  
Alessia Zanni ◽  
Concetta Sticozzi ◽  
Diego Penela Maceda ◽  
...  

Background Mobile computing and communication technologies in health services and information (so-called mHealth) have modified the traditional approach in the follow-up of patients with implantable cardiac devices, increased patient engagement and empowerment, reduced healthcare costs and improved patients' outcome. Recent developments in mobile technology, with the introduction of smartphone-compatible devices that can measure various health parameters and transfer automatically generated data, have increased the potential application of remote monitoring and the interest towards mHealth. However, little is known about the patients' interest and expectations of this new technology. Objective The patients' interest in the possibility of receiving data from their implantable cardiac device, clinical and health advice via remote monitoring on their smartphones were investigated. Methods A questionnaire entitled ‘Expectations for future possibility of self-management of device data’ (Likert scale scored) was submitted to 300 consecutive implantable cardiac device outpatients. The questionnaire was focused on collecting patients’ expectations in receiving direct information regarding their implantable cardiac device status (item 1, five questions), their own clinical status (item 2, seven questions) and advice on healthy lifestyle promotion (item 3, nine questions). Patient characteristics associated with greater interest towards mHealth were also investigated. Results Questionnaires were completed by 268 patients (221 men, aged 69 ± 14 years). The Cronbach test reported an alpha value of 0.98 for item 1, 0.94 for item 2 and 0.97 for item 3. Patients declared to be mainly interested in the device interventions (62%) and in severe arrhythmia occurrence (61%), followed by data on heart failure severity (54%) and their performed physical activity (48%). Patients showed very little interest in ECG tracing (37%), but the lowest interest was expressed towards healthy lifestyle promotion advice (<40%). A higher education degree and the presence of the caregiver positively affected the interest towards remote monitoring information ( P < 0.001). Conclusions The patients' interests were mainly directed at receiving information related to technical data of the implantable cardiac device and not to the overall management of the disease, underlying the insufficient awareness of patients towards the key role of self-control health status and the promotion of a healthy lifestyle.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
F Mendez Zurita ◽  
I Ramirez De Diego ◽  
H Espinosa Viamonte ◽  
E Rodriguez Font ◽  
B Campos Garcia ◽  
...  

Abstract Introduction Remote monitoring (RM) of cardiac devices is a technology established in clinical practice. The early activation of RM is associated with greater survival. The RM of leadless pacemakers consists of a non-automatic remote interrogation (RI), however factors such as age, the monitoring center and the type of device delivered can condition the adequate adherence to the system. Purpose Describe the results of RM in patients with leadless pacemakers in the clinical practice of a tertiary referral hospital. Methods All patients with leadless pacemakers were included. Since October 2017, RM was offered to all new patients and to previously implanted patients who had an elevated threshold. Clinical and demographic characteristics were analyzed. The following variables were evaluated: Activation (first RI), early activation (activation occurring before 90 days from the implant or from the medical order), premature activation (activation before 15 days), and adherence to follow-up (patients with almost one RI after 12 months from activation). Results A total of 142 patients have been implanted with a leadless pacemaker, of which 56 patients were offered RM, being accepted in 96% of the cases (54 patients, 88±6 years old, 54% males). A 54% patients received a RM using App based technology. During a mean follow-up of 200 days, 7 deaths occurred (13%). 100% of the patients have performed the activation, being in all cases an early activation, and in 50% (26 patients) it has been premature activation. 32 patients have follow-up longer than 12 months and all are adherent to RM. There are no differences in the percentage of activation or adherence depending on the type of monitor. Conclusions The implementation of RM program in old patients with a leadless pacemaker has a high acceptance rate, achieving an early activation in all patients. The adherence to this technology remains high despite the limitation of a non automatic transmission. RM using App based technology is possible in spite of the age.


2020 ◽  
Vol 2020 ◽  
pp. 1-4
Author(s):  
A. F. Lazo-Vasquez ◽  
J. A. Gonzales-Zamora

Mycobacterium peregrinum is a rapidly growing mycobacterium (RGM), subspecies of Mycobacterium fortuitum complex, which can cause infections in the skin, surgical sites, and central lines. It has also been associated with implantable devices such as cardiac devices. Our objective is to present an atypical clinical case of M. peregrinum infection associated with a cardiac device, review the published literature, and highlight the importance of this type of RGM infection to enhance their therapeutic success. Only two other cases have been reported of M. peregrinum infection associated with cardiac devices. Diagnosis and treatment of Mycobacterium peregrinum infection can be challenging, and the literature is scarce. Better understanding and further research should be conducted regarding this infection.


2019 ◽  
Vol 29 (10) ◽  
pp. 1243-1247
Author(s):  
Georgia Spentzou ◽  
Kaitlin Mayne ◽  
Helen Fulton ◽  
Karen McLeod

AbstractThere is growing interest in the use of digital medicine to reduce the need for traditional outpatient follow-up. Remote interrogation of pacemakers and implantable cardioverter defibrillators is now possible with most devices. The aim of our study was to evaluate the safety and efficacy of virtual pacing clinics in following up children with pacemakers and implantable cardioverter defibrillators, including epicardial systems.Methods:The study was retrospective over 8 years (2010–2017), with review of patient records and analysis of downloads from the implantable cardiac devices to the virtual clinics.Results:A total of 75 patients were set up for virtual clinic follow-up during the study period, 94.5% with a pacemaker and 5.5% an implantable cardioverter defibrillator. The majority (76.8%) had an epicardial system. Data on lead impedance, battery longevity, programmed parameters, detected arrhythmias, percentage pacing and delivered defibrillator therapies were obtainable by download. Lead threshold measurements were obtainable via download in 83.7% of the devices, including epicardial systems. No concerning device issue was missed. In 15% of patients a major issue was detected remotely, including three patients with lead fractures. The virtual clinics resulted in fewer hospital attendances while enhancing monitoring and enabling more frequent device checks. The vast majority (91.4%) of families who responded to a questionnaire were satisfied with the virtual clinic follow-up.Conclusions:Virtual clinics allow safe and effective follow-up of children with pacemakers and implantable cardioverter defibrillators, including those with epicardial systems and are associated with high levels of parent satisfaction.


Circulation ◽  
2018 ◽  
Vol 138 (Suppl_1) ◽  
Author(s):  
Ethan Hacker ◽  
Tawseef Dar ◽  
Bharath Yarlagadda ◽  
Valay Parikh ◽  
Brandon Wise ◽  
...  

Introduction: Management of voluminous data from implantable cardiac devices is resource intensive. False positive events can be especially problematic with implantable loop recorders (ILRs). We sought to describe our early experience with a novel ILR. Hypothesis: Sensitivity adjustment to <=0.10 mV may reduce false positive ILR detection of bradycardia/pauses. Methods: A single center retrospective study was performed in patients with the Abbott Confirm RX ILR. Tachycardia, atrial fibrillation (AF), bradycardia, and pause events were reviewed to determine whether they were true or false positives. Results: The study included 13 patients (age 67 ±15.8 years, 62% men). The reasons for implant included: AF (n=7, 54%), syncope(n=3, 23%), palpitations (n=2, 15%), and stroke (n=1, 8%). The median follow-up duration was 3.1 months (IQR 1.3-4.4 months). There was no change in serial R waves during mean follow-up of 0.58 months (pre 0.62±0.22 mV, post 0.63±0.22 mV, p=0.52). Tachycardia detection occurred in 6 patients (46%), with only 1 patient having a false positive episode. AF detection occurred in 8 patients (62%), with only 2 patients having true AF episodes. Pause/bradycardia episodes were detected in 5 patients (39%), with false positive episodes in 4 patients. There was no difference in R waves at implant among patients with and without false positive bradycardia/pauses episodes (0.66 ±0.27 vs. 0.44 ± 0.28 mV, p=0.21). The max sensitivity was higher among patients with than without false positive bradycardia/pause episodes (0.14 ±0.01, 0.07 ±0.02 mV, p<0.0001). No patients programmed to sensitivity <=0.10 mV had false positive bradycardia/pause episodes. The sensitivity was adjusted to <=0.10 mV in 3 of 4 patients with false positive bradycardia/pause episodes which eliminated future false positive episodes and did not result in false positive tachycardia/AF episodes. The overall mean monthly rate of false positive bradycardia/pause events was reduced from 387 events/month to zero in these patients. Conclusion: Programming the novel ILR to a sensitivity of <=0.10 mV resulted in a marked reduction in false positive bradycardia/pause episodes without an increase in false positive tachycardia/AF episodes.


2020 ◽  
Vol 13 (Suppl_1) ◽  
Author(s):  
Eliana Biundo ◽  
David Lanctin ◽  
Sarah C Rosemas ◽  
Emmanuelle Nicolle ◽  
Alan Burke

Background: As cardiac implantable electronic devices (CIEDs) have increased in complexity and sophistication, a transition from in-person follow-up to remote device management has taken place. The amount of information collected via cardiac devices has also increased, making the development of efficient workflows necessary for operational sustainability. Vendor-neutral clinic management software organizes patient, device, and programmer information, and thus has potential to improve remote monitoring workflow and data management. This study sought to examine whether management software use is associated with reduced time to review manage remote transmissions. Methods: A time and motion workflow analysis was performed in 6 U.S. cardiac device clinics, 3 of which use management software (Medtronic Paceart Optima™). Participating sites had an average size of 4,217 (range of 870 to 10,336) CIED patients managed. Each step involved in remote transmission review (including all clinical and administrative tasks, such as chart documentation and billing) was repeatedly timed, for all device models/manufacturers, during one business week (5 days) of observation at each clinic. The time to review an average remote transmission was calculated based on the mean time to perform each step as well as published literature, and stratified by sites with or without management software. Annual staff time required for remote monitoring was modeled by multiplying the average remote transmission review time by the average number of annual transmissions per patient across the 6 sites: 16.1 transmissions/year, representing a weighted average of therapeutic cardiac devices (4.2 transmissions/year) and insertable cardiac monitors (38.9 transmissions/year). Results: A total of 1,290 remote transmission review activities (725 with management software; 565 without management software) were observed and measured during 6 weeks of data collection. On average, the total staff time to review a remote transmission was 2.1 minutes lower at sites with management software (13.6 vs. 11.5 minutes). Extrapolated to the average clinic size of 4,217 patients, this translates into a potential annual time savings of 2,329 hours for sites with management software (13,026 vs. 15,355 hours of total transmission review time). This represents collective time savings across all clinical and administrative staff, and equates to 1.24 annual full-time equivalents (6.9 vs. 8.2 full-time equivalents). Conclusion: Remote monitoring of CIED patients requires significant staff time in cardiac device clinics. Management software is an effective tool in optimizing management of remotely monitored patients, and these benefits may translate into time savings for cardiac device clinics.


2016 ◽  
Vol 117 (9) ◽  
pp. 1455-1462 ◽  
Author(s):  
Joseph A. Ladapo ◽  
Mintu P. Turakhia ◽  
Michael P. Ryan ◽  
Sarah A. Mollenkopf ◽  
Matthew R. Reynolds

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