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. 2021 Aug 2;2(5):463-471.
doi: 10.1016/j.hroo.2021.07.008. eCollection 2021 Oct.

Performance of first pacemaker to use smart device app for remote monitoring

Khaldoun G Tarakji  1 , Amir M Zaidi  2 , Steven L Zweibel  3 , Niraj Varma  1 , Samuel F Sears  4 , James Allred  5 , Paul R Roberts  6 , Naushad A Shaik  7 , Josh R Silverstein  8 , Abdul Maher  9 , Suneet Mittal  10 , Ashish Patwala  11 , John Schoenhard  12 , Martin Emert  13 , Giulio Molon  14 , Giuseppe Augello  15 , Nilam Patel  16 , Hanscy Seide  17 , Antonio Porfilio  18 , Baerbel Maus  19 , Sherry L Di Jorio  20 , Keith Holloman  20 , Ana C Natera  20 , Mintu P Turakhia  21   22
Affiliations

Performance of first pacemaker to use smart device app for remote monitoring

Khaldoun G Tarakji et al. Heart Rhythm O2. .

Abstract

Background: High adherence to remote monitoring (RM) in pacemaker (PM) patients improves outcomes; however, adherence remains suboptimal. Bluetooth low-energy (BLE) technology in newer-generation PMs enables communication directly with patient-owned smart devices using an app without a bedside console.

Objective: To evaluate the success rate of scheduled RM transmissions using the app compared to other RM methods.

Methods: The BlueSync Field Evaluation was a prospective, international cohort evaluation, measuring the success rate of scheduled RM transmissions using a BLE PM or cardiac resynchronization therapy PM coupled with the MyCareLink Heart app. App transmission success was compared to 3 historical "control" groups from the Medtronic de-identified CareLink database: (1) PM patients with manual communication using a wand with a bedside console (PM manual transmission), (2) PM patients with wireless automatic communication with the bedside console (PM wireless); (3) defibrillator patients with similar automatic communication (defibrillator wireless).

Results: Among 245 patients enrolled (age 64.8±15.6 years, 58.4% men), 953 transmissions were scheduled through 12 months, of which 902 (94.6%) were successfully completed. In comparison, transmission success rates were 56.3% for PM manual transmission patients, 77.0% for PM wireless patients, and 87.1% for defibrillator wireless patients. Transmission success with the app was superior across matched cohorts based on age, sex, and device type (single vs dual vs triple chamber).

Conclusion: The success rate of scheduled RM transmissions was higher among patients using the smart device app compared to patients using traditional RM using bedside consoles. This novel technology may improve patient engagement and adherence to RM.

Keywords: Digital health; Pacemaker; Remote monitoring; Smart devices; Telemedicine.

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Figures

None
Graphical abstract
Figure 1
Figure 1
BlueSync Field Evaluation design schematic. Evaluation workflow from implant through completion.
Figure 2
Figure 2
Patient flowchart. Disposition of patients enrolled in the BlueSync Field Evaluation.
Figure 3
Figure 3
Remote monitoring transmission success by technology. Comparison of scheduled transmission success rates between 1 and 12 months follow-up between app group, pacemaker (PM) manual group, PM wireless group, and implantable cardioverter-defibrillator wireless group. Matched analysis of the groups was performed with regard to age, sex, and device type.
Figure 4
Figure 4
United States remote monitoring acceptance. Remote monitoring acceptance among screened patients (prior to enrollment) from the United States.
See this image and copyright information in PMC

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