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Remote Antiarrhythmic Drug Loading May Be Feasible - Pilot Study

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  1. The Good Doctor

    The Good Doctor Golden Member

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    Using existing telehealth technologies, researchers found they could perform electrocardiographic monitoring while patients in their homes loaded the antiarrhythmic drug Sotalol, according to a pilot study.

    Three patients with symptomatic, paroxysmal atrial or ventricular arrhythmias were safely started on the drug via telemedicine, researchers report in the European Heart Journal - Digital Health. All the patients had an existing implantable cardioverter-defibrillator prior to the study.

    "This pilot study, burgeoned from an epidemiological necessity for distancing during the COVID-19 pandemic, is a proof-of-concept for expansion of telemedicine including remote AAD (antiarrhythmia drug) loading and ultimately highlights the potential for a larger trial to 1) better assess the safety of virtual AAD loading, and 2) to investigate an expanded role for wearable defibrillators," write the authors, led by Dr. Rajan Shah, of the department of Medicine at Stanford University School of Medicine and the section of cardiac electrophysiology at Stanford University Medical Partners in Oakland, California.

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    The authors did not respond to requests for comment.

    To look at the feasibility of remotely monitoring the loading of AADs, Dr. Shah and his colleagues chose three patients with implantable cardioverter-defibrillators. Patient electrocardiograms were generated with a Kardia 6L mobile sensor were used to monitor QT intervals. An interpretable baseline was obtained prior to the initial AAD dose. The longest manual measurement from any of six leads was used to guide decision making.

    The researchers monitored arrhythmias remotely through transmission from existing ICD and adhesive patch Mobile Cardiac Outpatient Telemetry. Clinicians spoke with the patients twice a day via telemedicine video visits after telemetry review and QTc analysis. Participants would receive instructions directly to either terminate the study or proceed with the next dose of AAD. The end of the study was designed to occur when a participant had taken five doses of AAD or if pro-arrhythmia manifestations were identified on electrocardiographic monitoring.

    The patients started with a single outpatient phlebotomy and 12-lead ECG and from there, all monitoring was done remotely. The three patients included: a 35-year-old woman with hypertrophic cardiomyopathy, EF 35%, and symptomatic paroxysmal atrial fibrillation who completed loading; a 40-year-old man with alpha-actinin-2 deletion, history of ventricular fibrillation, sinus bradycardia, and symptomatic paroxysmal atrial fibrillation who completed loading; and a 60-year-old male with hypertrophic cardiomyopathy and symptomatic ventricular tachycardia episodes refractory to Sotalol 80 mg twice daily who completed dose escalation to Sotalol 120 mg every 12 hours.

    All three patients ranked their overall satisfaction with their care at the highest level (10 out of 10). Their initial reasons for agreeing to take part in the study were "avoiding contact" with the healthcare system during the pandemic "while continuing to receive care."

    The authors did a good job with their pilot study choosing patients who could be safely monitored remotely because they already had implantable defibrillators, said Dr. Charles Love, a professor of medicine and director of cardiac rhythm device services at the Johns Hopkins Hospital and School of Medicine in Baltimore.

    "This very small pilot study does show the utility of doing this," Dr. Love said. "The next step, as the authors suggest, is to broaden it. The question is: can we safely do this in a larger population? Many of these drugs are labeled by the FDA (Food and Drug Administration) such that the patient has to be in the hospital to start the medication so they can be safely monitored. They did the first step in a protected population."

    Typically, patients are brought into the hospital for loading because it's possible for them to develop an adverse reaction that could lead to a lethal heart rhythm, Dr. Love said. "If this can be done remotely it would be a great time saver and money saver for everybody involved," he added.

    Another issue for those who want to pursue this type of technology is whether insurers will pay for the remote monitoring, Dr. Love said, adding that lately some third-party payers have pulled back from wanting to pay for telemedicine visits.

    While the study showed that remote monitoring may be feasible, it may not be popular with patients, said Dr. N.A. Mark Estes, a cardiac electrophysiologist at the UPMC Heart and Vascular Institute in Pittsburgh. "All three patients in this case were satisfied because they preferred it to coming into the clinic in the context of a risk of contacting someone with COVID-19," he added. "Patient satisfaction cannot really be assessed adequately from this small study."

    —Linda Carroll

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