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May 11, 2020
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Pacemakers with Bluetooth capabilities confer improved transmission success rates

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Khaldoun G. Tarakji

Pacemakers that were compatible with technology for remote monitoring with a smartphone or tablet had a higher rate of scheduled transmission success compared with other remote monitoring options that required a wand or wireless automatic communication to a bedside console, according to data presented at the virtual Heart Rhythm Society Annual Scientific Sessions.

Perspective from Jodie L. Hurwitz, MD, FHRS

“BlueSync (Medtronic) is really a testament to the advancement of technology of both the pacemakers’ capabilities as well as defibrillators, and the wide adoption and the evolution of Bluetooth technology,” Cardiology Today Next Gen Innovator Khaldoun G. Tarakji, MD, MPH, associate section head of cardiac electrophysiology and director of the Center for Digital Health at the Heart and Vascular Institute at Cleveland Clinic, told Healio. “This is now allowing patients, for the first time, to use their own smart device, whether it’s their smartphone or tablet, as their monitors.”

Patients with implanted devices

In this prospective, multicenter, international evaluation study, researchers analyzed data from patients from April to December 2018 who had a device, pacemaker or cardiac resynchronization therapy pacemaker that was compatible with the remote monitoring technology (BlueSync, Medtronic). Patients had at least one scheduled transmission within 12 months after enrollment.

“It’s important to note that this was not a randomized trial, so the cohorts were historical cohorts from the same network using those different modalities for remote monitoring,” Tarakji said during the press conference.

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Scheduled transmission success rate of pacemakers with BlueSync compared with those with wand transmission and passive transmission.

Information transmission from the device required a smart device and an internet connection through Wi-Fi or cellular network.

“Basically the device itself that is implanted will communicate with the patient’s smart device, whether it’s a smartphone or a tablet, through Bluetooth, and then that smartphone or that smart tablet will act as a vehicle to transmit the signal to the secured network,” Tarakji said in an interview. “All you need is an internet connection or to make that happen. There’s no more need for any console; as long as you have your phone on, as long as you’re in close proximity within Bluetooth range, no matter where you are in the world, you don’t need to be adjacent to any console.”

In addition to assessing BlueSync (n = 245; mean age, 65 years; 42% women), there were three comparison control groups:

  • patients with pacemakers that required a wand to manually communicate information with a bedside console (n = 979; mean age, 72 years; 48% women);
  • those with pacemakers with wireless automatic communication through a bedside console and passive transmission (n = 980; mean age 75 years; 46% women); and
  • patients with defibrillators with similar automatic communication (n = 980; mean age, 66 years; 30% women).
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Transmission success was 94.6% for BlueSync (95% CI, 91.8-96.6), 56.3% for those with pacemakers with wand transmission (95% CI, 53.7-58.9), 77% for patients with pacemakers with wireless automatic communication through a bedside console and passive transmission (95% CI, 74.4-79.4) and 87.1% for those with defibrillators with automatic transmission (95% CI, 85.2-88.8).

Additionally, the investigators compared the BlueSync study patients with 811 patients (mean age, 69 years; 62% men) who were using the same technology in the real world but outside the study and found that they had a similar transmission success rate at 92.8% (95% CI, 91.1-94.1).

In addition, through the dedicated app on their smart devices, patients with BlueSync-compatible pacemakers were able to view certain aspects of their data.

“For the first time, in addition to being a vehicle for conducting the remote transmission, the app installed on the smartphone or tablet provides patients with visibility to some data elements including the type of device, data from their activity tracker ... and a schedule of those transmissions. You get a checkmark whether the scheduled transmission actually took place,” Tarakji told Healio.

Impact on practice, research

Tarakji also told Healio how this technology can lead to more possibilities not only in a clinical setting, but also with regard to research.

“This is the tip of the iceberg from a clinical perspective and hopefully will have more outcome data in the future” he said. “From a research perspective, it’s going to be an amazing way to conduct large device trials potentially at a much lower cost.” – by Darlene Dobkowski

Reference:

Tarakji KG, et al. LBCT04-05. Presented at: Heart Rhythm Society Annual Scientific Sessions; May 6-9, 2020 (virtual meeting).

Disclosure: This study was supported by Medtronic. Tarakji reports he consulted and served on advisory boards for AliveCor, Boston Scientific, Johnson & Johnson and Medtronic.