key: cord-0062540-9ix19xka
authors: Shah, Rajan L; Kapoor, Ridhima; Bonnett, Colleen; Ottoboni, Linda K; Tacklind, Christine; Tsiperfal, Angela; Perez, Marco V
title: Antiarrhythmic Drug Loading at Home Using Remote Monitoring: A Virtual Feasibility Study During COVID-19 Social Distancing
date: 2021-03-25
journal: Eur Heart J Digit Health
DOI: 10.1093/ehjdh/ztab034
sha: f8bf1334017f69a17cb4ce7cc067d7b257f83569
doc_id: 62540
cord_uid: 9ix19xka

The epidemiological necessity for distancing during the COVID-19 pandemic has resulted in postponement of non-emergent hospitalizations and increase use of telemedicine. The feasibility of virtual antiarrhythmic drug (AAD) loading specifically with digital QTc electrocardiographic monitoring (EM) in conjunction with telemedicine video visits is not well established. We tested the hypothesis that existing digital health technologies and virtual communication platforms could provide EM and support medically guided AAD loading for patients with symptomatic tachyarrhythmia in the ambulatory setting, while reducing physical contact between patient and healthcare system. A prospective pilot, case series approved by the institutional ethics committee, entailing three subjects with symptomatic arrhythmia during the COVID-19 pandemic who were enrolled for virtual AAD loading at home. Clinicians met with participants twice daily via video visits conducted after QTc analysis (Kardia 6L mobile sensor) and telemetry review (Mobile Cardiac Outpatient Telemetry of silent arrhythmias). Participants received direct instruction to either terminate the study or proceed with the next single dose of AAD. All participants completed contactless loading of 5 AAD doses, without untoward event. Scheduled video visits allowed dialogue and participant counseling where decision making was guided by remote review of EM. Participant adherence with transmissions and scheduled visits was 98.3%; a single electrocardiogram was delayed beyond the two-hours-post-dose schedule. This virtual approach reduced overall expenditures based on retrospective comparison with previous AAD load hospitalizations. We found that a ‘virtual hospitalization’ for AAD loading with remote electrocardiographic monitoring and twice daily virtual rounding is feasible using existing digital health technologies.

Introduction: Guideline-directed management of symptomatic tachyarrhythmia includes strategic rhythm control.

Outpatient initiation of the antiarrhythmic drug (AAD) Sotalol is permitted on an individualized basis, 1,2 though clinicians often pursue Sotalol loading and dose escalation with hospitalization to enable electrocardiographic monitoring (EM) for QT interval prolongation or ventricular arrhythmias. The epidemiological necessity for distancing during the COVID-19 pandemic has resulted in postponement of non-emergent hospitalizations, as well as increase use of telemedicine by healthcare systems to care for its patients. 3 While trans-telephonic ECG has been used in the past to help monitor effectiveness of AAD, the feasibility of a 'virtual hospitalization' for AAD loading specifically with remote QTc monitoring in conjunction with telemedicine video visits has not been well established.

We tested the hypothesis that existing digital health technologies and virtual communication platforms could provide EM and support medically guided AAD loading for patients with symptomatic tachyarrhythmia in the ambulatory setting.

We completed a prospective pilot study approved by the institutional ethics committee, entailing three subjects during the COVID-19 pandemic who were enrolled for virtual AAD loading at home following informed consent. We included individuals with symptomatic, paroxysmal atrial or ventricular arrhythmias and indication for rhythm control based on guidelines. 1 An existing implantable cardioverter-defibrillator (ICD) was mandatory for protection against drug-induced arrhythmia. Electrocardiograms generated with a Kardia 6L mobile sensor (AliveCor, Mountain View, CA) were used for QT interval monitoring and an interpretable baseline was necessary prior to the initial AAD dose; the longest manual measurement from any of 6 leads was used to guide decision-making. Remote transmission from existing ICD (Carelink portal, Medtronic, Dublin, Ireland) and adhesive patch Mobile Cardiac Outpatient Telemetry (MCOT; Zio AT, iRhythm portal, San Francisco, CA) were used to monitor arrhythmias. EM transmissions were reviewed at baseline and twice daily at specified times;

Clinicians met with participants virtually twice daily via telemedicine video visits conducted after telemetry review and QTc analysis; participants received direct instruction to either terminate the study or proceed with the next single dose of AAD. The study was completed when a participant had taken 5 doses of AAD or if manifestations of pro-arrhythmia were identified on EM. Upon completion, encounters were reviewed for overall costs and participants were asked to complete a questionnaire surveying comfort using the Kardia 6L device, motivation for participation, and open-ended feedback regarding the delivery of telemedicine care and overall experience during the study. Relief from "avoiding contact" with the healthcare system during the pandemic "while continuing to receive care" was the strongest motivator for participation. Initially participants described less than maximal (<7/10) perceived ease using the Kardia 6L, however, by the completion of the study each reported the highest level of comfort operating the mobile sensor and transmitting ECGs. All three participants ranked overall satisfaction with their care at the highest rating (10/10), driven by "convenience," "effective communication," and symptom relief. Beyond COVID-19 concerns, participant #1 offered a major perceived benefit of avoiding separation from her child, and participant #2, avoiding missing essential work. If a future AAD load was recommended, unanimously all participants favored virtual loading.

We demonstrate a potential contactless care pathway to virtually direct the loading of AAD for patients with symptomatic atrial and ventricular arrhythmia and existing ICD, applying 1) serial digital QTc, 2) remote patch telemetry, and 3) telemedicine visits. Scheduled visits by video allowed dialogue and participant counseling, akin to inpatient rounding, where decision making was guided by remote review of EM, including examination of baseline and 2-hour-post-dose electrocardiograms. The Kardia 6L device received FDA clearance for QT interpretation through demonstrated accuracy compared with 12-lead ECG 4, 5 and was utilized in our study to remotely monitor for QTc prolongation while administering Sotalol at home. Although select MCOT devices have received similar approval from the FDA, we used the Zio AT monitor strictly as telemetry. Initial and final Kardia 6L

ECGs were compared for QT analysis to 12-lead ECGs performed pre and post study completion, respectively, This virtual approach appears to reduce overall expenditures based on retrospective comparison with previous AAD load hospitalizations 6, 7 Table] , though economic benefit should be validated in a larger study. It ought to be highlighted, amongst only three participants the adherence to the EM transmission schedule was near but not perfect, and use of automated reminder notifications may be beneficial to both patients and clinicians; 8 also, motion artifact can limit manual analysis of the Kardia 6L ECG which may be corrected by trans-telephonic instruction and repeat transmission. This pilot study, burgeoned from epidemiological necessity for distancing during the COVID-19 pandemic, is a proof-of-concept for expansion of telemedicine including remote AAD 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.

In conclusion, we found that a 'virtual hospitalization' for AAD loading with remote electrocardiographic monitoring and twice daily virtual rounding is feasible using existing digital health technologies. 

AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Study

Amiodarone versus sotalol for atrial fibrillation

Guidance for rebooting electrophysiology through the COVID-19 pandemic from the Heart Rhythm Society and the American Heart Association Electrophysiology and Arrhythmias Committee of the Council on Clinical Cardiology: Endorsed by the American College of Cardiology

Comparison of QT interval readings in normal sinus rhythm between a smartphone heart monitor and a 12-lead ECG for health volunteers and inpatients receiving Sotalol or Dofetilide

Multilead QT screening is necessary for QT measurement: Implications for management of patients in the COVID-19 era

Cost of hospital admission for antiarrhythmic drug initiation in atrial fibrillation

Cost effectiveness of inpatient initiation of antiarrhythmic therapy for supraventricular tachycardias