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Medtronic's Micra transcatheter pacing system received FDA approval in April 2017.  It's competitor, St. Jude's Nanostem, received initial FDA approval in 2013, but was recalled due to premature battery failure and spontaneous detachment of it's docking button (Bhatia & El-Chami, 2018). The following video from Baycare (2016) provides more detail on placement and function.

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Medtronic Micra Transcatheter Pacing System - BayCare

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The Similarities and Differences: Why Micra Leads the Market📈  

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The Similarities and Differences: Why Micra Leads the Market📈  

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Both systems are placed percutaneously via the right femoral vein and are placed with a catheter delivery system.  In the LEADLESS II study, the Nanostim caused a higher than expected abrupt battery failure rate. In addition, 6.5% of patient experienced device related adverse events. Pericardial effusions occured in 1.5% and there were 6 device dislodgements in the first month of the study.  The Micra has simply performed better. There has been no evidence of battery failure in the Micra and there was one dislodgement in the Micra Pacing Post Approval study(Bhatia & El-Chami, 2018). Below is a photo, courtesy of DukeHealth (2015), of the two systems comparing their size to a traditional medtronic pacemaker.

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Leadless Pacemaker: Less Invasive, Fewer Complications

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Placement takes one hour and requires an overnight hospital stay with 4 hours of bedrest to establish hemostasis at the groin site (Bulger-Noto, 2018)

Recovery is faster than traditional permanent pacemakers and there is no left arm movement restrictions post-operatively

There are less complications than traditional permanent

Pacer can be programmed for use inside an MRI.

There is no subcutaneous implantation of a battery pack, so it's aesthetically more appealing to patients as Robert explains below in the video (MedtronicCardiac, 2016)

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They are single chamber devices only available for patients needing ventricular demand pacing (VVIR )

Only 20% of patients needing permanent pacemakers received single chamber devices

Not much is known about long-term performance, maintenance, end of service management, and retrieval

Patients still have to protect themselves from electromagnetic energy from metal detectors, boat motors, electric fences, power sources over 200 amps, CB radios and other transmitters (Medtronic, n.d.)

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The Micra Leadless Pacer: My Opinion and Rationale 💭

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The Micra Leadless Pacer: My Opinion and Rationale 💭

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I think this device is revolutionary because it seems safe and saves patient's from post-permanent pacemaker placement related body image issues. So far, the data suggests it is safe, but we have no idea what the long term performance of the device will be. What is most exciting for me are the implications for applying this technology to multi-chamber cardiac dysfunction patients. It's potential cost and whether or not it is covered by most insurance plans concerns me. Although I could not find any definitive 2019 cost data, I suspect it would be far more expensive than traditional pacemakers. My suspicion lies in the fact that although the technology exists, traditional pacemakers are what patients are currently being offered in my practice. The technology is impressive, but I fear that its cost may affect its reach for the foreseeable future. I love it. I'd love it more if it is affordable enough for everyone who needs it.

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Baycare. (2016). Medtronic Micra Transcatheter Pacing System-Baycare. Retrieved from https://youtu.be/ufJ8TamUSF0

Bhatia, N., & El-Chami, M. (2018). Leadless pacemakers: a contemporary review. Journal of geriatric cardiology : JGC, 15(4), 249–253. doi:10.11909/j.issn.1671-5411.2018.04.002

Bulger-Noto, J. (2018) A new technology in cardiac pacing: Learn about the nursing implications of these innovative devices. American Nurse Today, 13(10), 18-26. Retrieved from https://www.americannursetoday.com/leadless-pacemakers-cardiac-pacing/

DukeHealth. (2015). Retrieved from https://www.dukehealth.org/sites/default/files/20150317.pacemakers.03_0.jpg

Loyola Medicine. (2018). Leadless Pacemaker: Less Invasive, Fewer Complications. Retrieved from: https://youtu.be/Ig_zD0KCBV0

MedtronicCardiac. (2016). Micra Patient - Robert. Retrieved from https://youtu.be/ZVQu4edvNaw

Medtronic. (n.d.). Electromagnetic Compatibility With Your Heart Device. Retrieved from https://www.medtronic.com/us-en/patients/treatments-therapies/living-with-heart-device/electromagnetic-compatibility.html

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My top 5 strengths are  individualization, arranger, connecredness, restorative, and responsibility.
The people I choose for my team, based on their top strength are:

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