A novel coronavirus (SARS-CoV-2) that was first reported in late 2019 has led to an ongoing global pandemic of COVID-19. SARS-CoV-2 is highly contagious, and primarily spreads from person to person through respiratory particles generated when an infected person coughs, sneezes, or speaks. In order to preserve the limited supply of personal protective equipment (PPE) and prevent patients from contracting or transmitting COVID-19 in the hospital setting, many hospitals have limited medical industry representatives from entering the hospital to support procedures and surgeries, and many device clinics have transitioned to having remote-only or “drive-through” clinics.
This article outlines the application of RemoteControl™ (Medtronic) technology, which offers real-time remote testing and programming of a cardiac implantable electronic device (CIED) without the need for clinical device specialists (manufacturer’s representatives and device clinic nurses) in the electrophysiology (EP) lab.
In response to the COVID-19 pandemic, we began to utilize specific strategies to minimize potential exposure to EP lab staff and device specialists. This included implementing pre-procedural PCR testing for patients scheduled for elective procedures, donning appropriate PPE, and designating 2 procedure suites specifically for “COVID-19 cases” for patients with confirmed or unknown COVID-19 status. We also introduced RemoteControl in April 2020 to help reduce the number of EP personnel in the lab and further minimize the risk of person-to-person viral transmission in the lab setting, while ensuring optimal CIED management and device-specific expertise from the manufacturer’s device specialists (Figure 1). We have since routinely used this technology in a variety of clinical scenarios, including conventional transvenous pacemaker and defibrillator as well as leadless Micra AV and Micra VR device (Medtronic) implantations. All procedures are remotely supported by the manufacturer’s device specialists either from a control room or their home office (Figure 2). Pacemaker implantation has to be performed in a patient with complete heart block and confirmed active COVID-19 infection while only an anesthesiologist, an attending electrophysiologist, and a circulating nurse are present in the procedure room. Patients with ventricular assistant devices (VAD) can undergo CIED implantations with remote interrogation and programming, while others can undergo concurrent AV nodal radiofrequency ablation at the time of device implantation. There have been no observed errors with programming and no adverse interactions with other aspects of standard EP care (VAD, catheter ablation) for over 20 cases we have performed using this technology. Device response to remote programming is nearly simultaneous, and there is no perceptible delay.
The Medtronic 2090 Programmer with RemoteControl is an FDA-approved technology that allows a device nurse or manufacturer’s device specialist to remotely operate the bedside programmer and program devices in real-time in accordance with a physician’s orders. The system consists of the RemoteControl software installed 2090 programmer, a laptop installed with the RemoteControl remote console software, and the coordinating central server located at the Secure Data Center (Figure 3). The RemoteControl software has embedded security procedures to authenticate and protect the connection. Off-site device specialists verbally inform a unique session key generated by the central server to the local EP lab staff in order to establish a cryptographically secure connection with the bedside 2090 programmer (this is completed before patients enter the EP lab). The connection to the device is made by the EP staff through the use of the standard programmer. The device specialist then uses RemoteControl to complete all features of device testing from any remote location in the U.S.
Although there is a safety feature to revert to the nominal bradycardia pacemaker settings in case of loss of communication between the in-lab programmer and the device personnel’s laptop, there has been neither loss or delay of communication in our experience. As an additional safety feature, if the EP lab staff in the lab during the procedure and a remote device specialist press the programmer screen at the same time, the priority is invariably given to the local team in the EP lab, who can override and supersede the remote programming operation. A programmer is always located at the bedside in the lab and turned on at the time of the procedure. During each procedure, the implanting physician maintained real-time communication with the off-site device specialist, using a third-party audio-visual device.
While this technology has several clinical implications with regard to minimizing personnel exposure to COVID-19 infection, other advantages include expeditious remote device reprogramming in the outpatient settings for MR imaging, radiotherapy, and surgeries requiring electrocautery within close proximity to the device. In palliative care settings, the technology may also allow prompt deactivation of the defibrillator in terminally ill patients.
In summary, RemoteControl technology provides immediate and device-specific expertise from device specialists without their physical presence in the EP lab. This capability may play an important role in infectious risk control in the era of the COVID-19 global pandemic.
Acknowledgements: The authors acknowledge Michael R. Aulino, BS, BA, and Andrew C. Frye, BA, BSN, both employees of Medtronic plc, for providing technical support for the use of RemoteControl technology. The authors also acknowledge the dedicated and hard-working staff of our EP lab at the Ohio State University Ross Heart Hospital.
Disclosures: The authors have received research grants and fellowship support from Medtronic, Boston Scientific, Abbott, BIOTRONIK, and Biosense Webster, and consulting honoraria and speaking fees from Medtronic, Abbott, and Respicardia
Video 1: Micra AV implantation using RemoteControl technology supported by an outside-the-hospital device technician.