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HRS/EHRA/APHRS/LAHRS/ACC/AHA worldwide practice update for telehealth and arrhythmia monitoring during and after a pandemic

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2020

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Abstract

1.Need for digital health during the COVID-19 pandemic 22.Monitoring strategies during a pandemic: Here to stay 33.Therapy for COVID-19 and potential electrical effects 74.The future: Digital medicine catalyzed by the pandemic 9References 10 Coronavirus disease 2019 (COVID-19), caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), started in the city of Wuhan in late 2019. Within a few months, the disease spread toward all parts of the world and was declared a pandemic on March 11, 2020. The current health care dilemma worldwide is how to sustain the capacity for quality services not only for those suffering from COVID-19 but also for non-COVID-19 patients, all while protecting physicians, nurses, and other allied health care workers. The pandemic poses challenges to electrophysiologists at several levels. Hospitalized COVID-19-positive patients may have preexisting arrhythmias, develop new arrhythmias, or be placed at increased arrhythmic risk from therapies for COVID-19. Cardiac arrhythmia incidence in hospitalized patients has been documented in a few published studies, with reported rates of 7.9%1Goyal P. Choi J.J. Pinheiro L.C. et al.Clinical characteristics of Covid-19 in New York City.N Engl J Med. 2020; 382: 2372-2374Crossref PubMed Scopus (1524) Google Scholar and 16.7%2Wang D. Hu B. Hu C. et al.Clinical characteristics of 138 hospitalized patients with 2019 novel coronavirus-infected pneumonia in Wuhan, China.JAMA. 2020; 323: 1061-1069Crossref PubMed Scopus (15459) Google Scholar in hospitals in New York City and Wuhan, respectively, and up to 44%2Wang D. Hu B. Hu C. et al.Clinical characteristics of 138 hospitalized patients with 2019 novel coronavirus-infected pneumonia in Wuhan, China.JAMA. 2020; 323: 1061-1069Crossref PubMed Scopus (15459) Google Scholar in patients requiring intensive care. Life-threatening arrhythmias (ventricular tachycardia [VT]/ventricular fibrillation [VF]) can occur in up to 6% of hospitalized patients with COVID-19 infection.3Guo T. Fan Y. Chen M. et al.Cardiovascular implications of fatal outcomes of patients with coronavirus disease 2019 (COVID-19).JAMA Cardiol. 2020; 5: 811-818Crossref PubMed Scopus (2703) Google Scholar There have also been several case reports of atrioventricular block in hospitalized patients, which is otherwise rarely described during viral illness.4Azarkish M. Laleh Far V. Eslami M. Mollazadeh R. Transient complete heart block in a patient with critical COVID-19.Eur Heart J. 2020; 41: 2131Crossref PubMed Scopus (58) Google Scholar,5Noll A, William A, Varma N. A young woman presenting with a viral prodrome, palpitations, dizziness, and heart block. JAMA Cardiol. In press.Google Scholar Although the residual left ventricular dysfunction and arrhythmic risk are currently unknown, preliminary pathophysiological,6Kochi A.N. Tagliari A.P. Forleo G.B. Fassini G.M. Tondo C. Cardiac and arrhythmic complications in patients with COVID-19.J Cardiovasc Electrophysiol. 2020; 31: 1003-1008Crossref PubMed Scopus (405) Google Scholar histological,7Yao X.H. Li T.Y. He Z.C. et al.A pathological report of three COVID-19 cases by minimal invasive autopsies [in Chinese].Zhonghua Bing Li Xue Za Zhi. 2020; 49: 411-417PubMed Google Scholar and imaging8Inciardi R.M. Lupi L. Zaccone G. et al.Cardiac involvement in a patient with coronavirus disease 2019 (COVID-19).JAMA Cardiol. 2020; 5: 819-824Crossref PubMed Scopus (1250) Google Scholar data suggest that SARS-CoV-2 infection holds the potential to induce durable myocardial changes predisposing to arrhythmias or heart failure. Electrocardiographic monitoring and inpatient monitoring services may become necessary but face the potential hurdles of limited telemetry wards, contamination of equipment and infection in health care personnel, and shortage of personal protective equipment.9Sapp J.L. Alqarawi W. MacIntyre C.J. et al.Guidance on minimizing risk of drug-induced ventricular arrhythmia during treatment of COVID-19: a statement from the Canadian Heart Rhythm Society.Can J Cardiol. 2020; 36: 948-951Abstract Full Text Full Text PDF PubMed Scopus (94) Google Scholar,10Udwadia Z.F. Raju R.S. How to protect the protectors: 10 lessons to learn for doctors fighting the COVID-19 coronavirus.Med J Armed Forces India. 2020; 76: 128-131Crossref PubMed Scopus (32) Google Scholar In parallel, there is a continued responsibility to maintain care of COVID-19-negative patients with arrhythmias. These pressures have led to inventive utilization and adaptation of existing telemedicine technologies as alternative options. This document discusses how digital health may facilitate electrophysiology practice for patients with arrhythmia, whether hospitalized for COVID-19 or not. The representation of authors from some of the most severely affected countries, such as China, Spain, Italy, and the United States, is a tribute from our worldwide community to those colleagues who have worked on the front lines of the pandemic. In light of the current pandemic, monitoring strategies should focus on selecting high-risk patients in need of close surveillance and using alternative remote recording devices to preserve personal protective equipment and protect health care workers from potential contagious harm. For inpatient monitoring, telemetry is reasonable when there is concern for clinical deterioration (as may be indicated by acute illness, vital signs, or sinus tachycardia), or in patients with cardiovascular risk factors and/or receiving essential QT-prolonging medications. Telemetry is generally not necessary for persons under investigation without concern for arrhythmias or clinical deterioration and for those not receiving QT-prolonging drug therapy. In situations in which a hospital's existing telemetry capacity has been exceeded by patient numbers or when conventional telemetry monitoring is not feasible, such as off-site or nontraditional hospital units, mobile devices may be used, for example, mobile cardiac outpatient telemetry (MCT), as an adjunctive approach to support inpatient care.11Gabriels J. Saleh M. Chang D. Epstein L.M. Inpatient use of mobile continuous telemetry for COVID-19 patients treated with hydroxychloroquine and azithromycin.HeartRhythm Case Rep. 2020; 6: 241-243Abstract Full Text Full Text PDF PubMed Scopus (30) Google Scholar, 12Steinberg J.S. Varma N. Cygankiewicz I. et al.2017 ISHNE-HRS expert consensus statement on ambulatory ECG and external cardiac monitoring/telemetry.Heart Rhythm. 2017; 14: e55-e96Abstract Full Text Full Text PDF PubMed Scopus (186) Google Scholar, 13Garabelli P. Stavrakis S. Albert M. et al.Comparison of QT interval readings in normal sinus rhythm between a smartphone heart monitor and a 12-lead ECG for healthy volunteers and inpatients receiving sotalol or dofetilide.J Cardiovasc Electrophysiol. 2016; 27: 827-832Crossref PubMed Scopus (79) Google Scholar, 14Castelletti S. Dagradi F. Goulene K. et al.A wearable remote monitoring system for the identification of subjects with a prolonged QT interval or at risk for drug-induced long QT syndrome.Int J Cardiol. 2018; 266: 89-94Abstract Full Text Full Text PDF PubMed Scopus (41) Google Scholar, 15Gropler M.R.F. Dalal A.S. Van Hare G.F. Silva J.N.A. Can smartphone wireless ECGs be used to accurately assess ECG intervals in pediatrics? A comparison of mobile health monitoring to standard 12-lead ECG.PLoS One. 2018; 13e0204403Crossref PubMed Scopus (55) Google Scholar The majority of MCT devices can provide continuous arrhythmia monitoring using a single-lead electrocardiogram (ECG) and allow for real-time and offline analysis of long-term ECG data. Telemetry can be extended using patch monitoring.16US Food & Drug AdministrationVitalConnect, Inc. VitalPatch: letter of authorization (April 26, 2020).https://www.fda.gov/media/137397/downloadDate accessed: May 15, 2020Google Scholar,17VitalConnect. COVID-19.https://vitalconnect.com/covid-19-remote-patient-monitoringDate accessed: May 15, 2020Google Scholar Smartphone ECG monitors are wireless and have also been utilized during the current pandemic. Information is limited, however, on how parameters such as QTc measured on a single- (or limited number) lead ECG can reliably substitute for 12-lead ECG information.18Rimmer L.K. Rimmer J.D. Comparison of 2 methods of measuring the QT interval.Am J Crit Care. 1998; 7: 346-354Crossref PubMed Scopus (10) Google Scholar,19Rimmer L.K. Bedside monitoring of the QT interval.Am J Crit Care. 1998; 7: 183-189Crossref PubMed Scopus (7) Google Scholar In 1 study, QT was underestimated by the smartphone single-lead ECG.20Koltowski L, Balsam P, Glłowczynska R, et al. Kardia Mobile applicability in clinical practice: a comparison of Kardia Mobile and standard 12-lead electrocardiogram records in 100 consecutive patients of a tertiary cardiovascular care center [published online ahead of print January 15, 2019]. Cardiol J. https://doi.org/10.5603/CJ.a2019.0001.Google Scholar The principles of remote patient management, crossing geographic, social, and cultural barriers, can be extended to outpatient care and are important to maintain continuity of care for non-COVID-19 patients.21Ohannessian R. Telemedicine: potential applications in epidemic situations.Eur Res Telemed. 2015; 4: 95-98Crossref Scopus (94) Google Scholar, 22Hollander J.E. Carr B.G. Virtually perfect? Telemedicine for Covid-19.N Engl J Med. 2020; 382: 1679-1681Crossref PubMed Scopus (1939) Google Scholar, 23Liu S. Yang L. Zhang C. et al.Online mental health services in China during the COVID-19 outbreak.Lancet Psychiatry. 2020; 7: e17-e18Abstract Full Text Full Text PDF PubMed Scopus (1223) Google Scholar Virtual clinics move far beyond simple telephone contacts by integrating information from photos, videos, mobile heart rhythm and mobile health devices recording ECG, and remote cardiovascular implantable electronic device (CIED) interrogations.24Varma N. Ricci R.P. Telemedicine and cardiac implants: what is the benefit?.Eur Heart J. 2013; 34: 1885-1895Crossref PubMed Scopus (86) Google Scholar A variety of platforms have been developed and used specifically to provide telehealth to patients via video teleconferencing25NHSX. Information governance.https://www.nhsx.nhs.uk/covid-19-response/data-and-information-governance/information-governanceDate accessed: May 15, 2020Google Scholar,26NHS DigitalApproved video consultation systems.https://digital.nhs.uk/services/future-gp-it-systems-and-services/approved-econsultation-systemsDate accessed: May 15, 2020Google Scholar (Table 1). Most health care centers have expanded use of telemedicine, with some reporting 100% transformation of in-person clinic visits to telemedicine-based visits in order to maintain care for non-COVID-19 patients, thus obviating their need to come to the hospital or clinic. This supplements social distancing measures and reduces the risk of transmission, especially for the older and more vulnerable populations. It also becomes a measure to control intake into emergency rooms and outpatient facilities and to permit rapid access when necessary to subspecialists.Table 1Examples of commonly used platforms for telehealth25NHSX. Information governance.https://www.nhsx.nhs.uk/covid-19-response/data-and-information-governance/information-governanceDate accessed: May 15, 2020Google Scholar, 26NHS DigitalApproved video consultation systems.https://digital.nhs.uk/services/future-gp-it-systems-and-services/approved-econsultation-systemsDate accessed: May 15, 2020Google Scholar, 27National Health ServiceProcurement of pre-approved suppliers of online and video consultation systems for GP practices to support COVID-19.https://www.england.nhs.uk/coronavirus/wp-content/uploads/sites/52/2020/03/C0079-Suppliers-of-online-and-video-consultations.pdfDate accessed: April 29, 2020Google ScholarPlatformWebsiteHIPAA- or PHI-secure telehealth platformaccuRx∗United Kingdom.https://www.accurx.comAMD Global Telemedicine†Global.https://www.amdtelemedicine.com/telemedicine-products/Working-Clinic-Telemedicine.htmlAmerican Well‡United States.https://business.amwell.com/solution-overviewAttend Anywhere∗United Kingdom.https://www.attendanywhere.comBlueJeans for Healthcare‡United States.https://www.bluejeans.com/use-cases/healthcareCare Connect by KRY/LIVI§Europe.https://www.kry.careCaregility‡United States.https://caregility.com/uhe-applicationsCisco Webex†Global.https://www.webex.com/webexremotehealth.htmlClickDoc§Europe.https://www.cgm.com/be/index.fr.jspConexa Saúde¶South America—Brazil.https://www.conexasaude.com.brDocobo∗United Kingdom.https://www.docobo.co.ukDoctena§Europe.https://secure.doctena.comDoctorlink∗United Kingdom.https://www.doctorlink.com/video-consultationDoximity‡United States.https://www.doximity.comDoxy.me‡United States.https://doxy.meEMIS Health Video Consult∗United Kingdom.https://www.emishealth.com/products/video-consultationExprivia§Europe.https://www.exprivia.itFaceTalk§Europe.https://facetalk.nlGoogle G Suite†Global.https://gsuite.google.com/industries/healthcareHelena§Europe.https://qa.helena.careIntersysto§Europe.http://www.intersysto.euInTouch Health‡United States.https://intouchhealth.com/telehealth-solutionspMD‡United States.https://www.pmd.com/secure-messaging-telemedicineMicrosoft Teams/Skype for Business E3 and E5†Global.https://www.microsoft.com/en-us/microsoft-365/microsoft-teams/healthcare-solutionsSignal§Europe.ΔEncrypted, but not specifically a telehealth platform.https://signal.orgSilicon Practice FootFall∗United Kingdom.https://www.siliconpractice.co.uk/video-consultationsSpruce‡United States.https://www.sprucehealth.comTeleMedi§Europe.https://telemedi.beUpdox‡United States.https://www.updox.comUS Department of Veterans Affairs Video Connect‡United States.https://www.mobile.va.gov/app/va-video-connectVSee‡United States.https://vsee.comZoom for Healthcare†Global.https://zoom.us/healthcareProprietary EMR telehealth platformsVideo-conferencing platforms (not HIPAA- or PHI-secure)GoToMeetingSkypeZoomNon-public-facing mobile communication platforms (not HIPAA- or PHI-secure)Apple FaceTimeGoogle DuoGoogle HangoutsWhatsAppEMR = electronic medical record; HIPAA = Health Insurance Portability and Accountability Act; PHI = protected health information.∗ United Kingdom.† Global.‡ United States.§ Europe.¶ South America—Brazil.Δ Encrypted, but not specifically a telehealth platform. Open table in a new tab EMR = electronic medical record; HIPAA = Health Insurance Portability and Accountability Act; PHI = protected health information. Electrophysiology is well placed for virtual consultations. All preobtained data, including ECGs, ambulatory ECG monitoring, cardiac imaging, and coronary angiography can be adequately reviewed electronically. Digital tools such as direct-to-consumer mobile ECG (Table 2) and wireless blood pressure devices can be used to further complement the telehealth visit without in-person contact. CIED, wearable/mobile health, and clinical data can be integrated into the clinician workflow.Table 2Examples of remote ECG and heart rate monitoring devicesDeviceTypeCE markFDA clearanceAdditional features/notesWebsiteHandheld devicesAliveCor KardiaMobileWirelessYesYesFDA cleared for AF (1-lead) and for QTc (6L) for COVID-19 patients on HCQ ± AZMhttps://www.alivecor.com/kardiamobileBeurer ME 90Wireless1-lead ECGYesNohttps://www.beurer.com/web/gb/products/medical/ecg-and-pulse-oximeter/mobile-ecg-device/me-90-bluetooth.phpCardiac Designs ECG CheckWireless1-lead ECGYesYeshttps://www.cardiacdesigns.comCardioComm Solutions HeartCheck CardiBeat and ECG PenWireless1-lead ECGYesYeshttps://www.theheartcheck.comCOALAWireless1-lead ECGYesYesRemote lung auscultationhttps://www.coalalife.comEko DUOWireless1-lead ECGYesYesRemote cardiac auscultation/ phonocardiogramhttps://www.ekohealth.comOmron Blood Pressure + EKG MonitorWireless1-lead ECG + BP cuffNoYesUnited States and Canada onlyhttps://omronhealthcare.comEKGraphWireless1-lead ECGNoYesUnited Stateshttps://sonohealth.orgMobile cardiac telemetry devicesQardioQardioCoreChest strap1-lead ECGYesNoECG, HR, HRV, RR, activityhttps://www.getqardio.com/qardiocore-wearable-ecg-ekg-monitor-iphoneBardyDx CAMPatch1-lead ECGYesYesUnder clinical investigation for QTc monitoring in COVID-19 patientshttps://www.bardydx.comBioTel HeartPatch1-lead ECGYes—only for extended HolterYesFDA cleared for QTc monitoringhttps://www.myheartmonitor.com/device/mcot-patchBodyGuardian MINI Family/BodyGuardian MINI PLUSWirelessPatch: 1-lead ECG/Wired3-lead ECGYesYesECG, HR, HRV, RRhttps://www.preventicesolutions.com/hcp/body-guardian-mini-familyiRhythm Zio patch/Zio ATPatch1-lead ECGYesYeshttps://www.irhythmtech.comInfoBionic MoMe KardiaWired3-lead ECGYesYesRemote lung auscultationhttps://infobionic.comMediBioSenseMBS HealthStream, VitalPatch, MCTPatch1-lead ECGYesYesMonitors up to 8 vital signshttps://www.medibiosense.comMEMO PatchPatch/watch1-lead ECGNoNoAsia; Korea FDA approvedhttps://www.huinno.comMediLynx PocketECGWired3-lead ECGYesYesHRVhttps://www.pocketecg.comRhythMedix RhythmStarWired3-lead ECGNoYeshttps://www.rhythmedix.comSamsung S-patch CardioPatch1-lead ECGYesNoAsia; Korea FDA approvedhttps://www.samsungsds.com/global/en/solutions/off/cardio/cardio.htmlSmartwatchesApple Watch1-lead ECGYesYesFDA cleared for AF notificationhttps://www.apple.com/watchWithings Move ECG1-lead ECGYesNoRequires Health Mate app for ECG analysis/AF detectionhttps://www.withings.com/us/en/move-ecgAF = atrial fibrillation; AZM = azithromycin; BP = blood pressure; COVID-19 = coronavirus disease 2019; ECG = electrocardiogram; FDA = Food & Drug Administration; HCQ = hydroxychloroquine; HR = heart rate; HRV = heart rate variability; RR = respiratory rate. Open table in a new tab AF = atrial fibrillation; AZM = azithromycin; BP = blood pressure; COVID-19 = coronavirus disease 2019; ECG = electrocardiogram; FDA = Food & Drug Administration; HCQ = hydroxychloroquine; HR = heart rate; HRV = heart rate variability; RR = respiratory rate. Additional diagnostic information might be obtained without in-person contact using home enrollment of prescribed ambulatory rhythm monitors. Patch monitors can be mailed to patient homes and easily self-affixed, unlike Holter monitors with cables and electrodes requiring placement by health care workers. In some cases, new or follow-up telehealth visits will require an adjunctive in-person visit to perform a 12-lead ECG, ECG stress test, echocardiogram, or other diagnostic procedures. Occasionally, conventional clinic visits are required to accurately assess the impact of comorbidities or frailty on procedural risk, or to allow comfortable discussion with multiple family members when planning procedures with high risk. Telephone-only visits (ie, without video) may allow for a broader reach due to ease and ubiquitous accessibility as a communication strategy for immediate access for urgent matters. There are many barriers to implementation, such as inadequate reimbursement, licensing/regulatory and privacy issues, lack of infrastructure, resistance to change, lack of access/poor Internet coverage, restricted financial resources, and limited technical skills (eg, in the elderly patient population). Some telehealth and remote ECG monitoring technologies may be simply unaffordable and/or unavailable, leading to different levels of uptake within communities and across the globe. All stakeholders should collaborate to address these challenges and promote the safe and effective use of digital health during the current pandemic. In recent months, regulations have been eased to permit consults with new patients, issuing prescriptions, and obtaining consents. In that sense, the COVID-19 pandemic may serve as an opportunity to evolve current technologies into indispensable tools for our future cardiological practice. No specific cure exists for COVID-19.28Grein J. Ohmagari N. Shin D. et al.Compassionate use of remdesivir for patients with severe Covid-19.N Engl J Med. 2020; 382: 2327-2336Crossref PubMed Scopus (1957) Google Scholar, 29European Society of CardiologyESC guidance for the diagnosis and management of CV disease during the COVID-19 pandemic.https://www.escardio.org/Education/COVID-19-and-Cardiology/ESC-COVID-19-GuidanceGoogle Scholar, 30Chen Z. Hu J. Zhang Z. et al.Efficacy of hydroxychloroquine in patients with COVID-19: results of a randomized clinical trial.medRxiv. 2020; (2003.2022.20040758. https://doi.org/10.1101/2020.03.22.20040758)Google Scholar Potential COVID-19 therapies, especially hydroxychloroquine and azithromycin, are being investigated in ongoing trials but also have been used off-label in many parts of the world. These may exert QT-prolonging effects31Haeusler I.L. Chan X.H.S. Guérin P.J. White N.J. The arrhythmogenic cardiotoxicity of the quinoline and structurally related antimalarial drugs: a systematic review.BMC Med. 2018; 16: 200Crossref PubMed Scopus (96) Google Scholar (Table 3) and, since recent observational data have questioned their efficacy, require a careful risk-benefit J. Y. J. et of hydroxychloroquine in hospitalized patients with Covid-19.N Engl J Med. 2020; 382: PubMed Scopus Google Scholar (eg, hydroxychloroquine and may have effects on QT L, et al. QT interval and in patients with COVID-19 treated with [published online ahead of print May 11, Heart Rhythm. M. J. Chang D. et of and on the QT interval in patients with SARS-CoV-2 Electrophysiol. 2020; PubMed Scopus Google Scholar In a of COVID-19 patients hospitalized in New York (ie, a disease cardiac was more in patients who hydroxychloroquine with in patients who T. et of treatment with hydroxychloroquine or with in patients with COVID-19 in New York 2020; 323: PubMed Scopus Google Scholar The for for treatment with hydroxychloroquine was for was and for hydroxychloroquine and was of these The observational of may of these In the of data, treatment should be into their potential for which may be by of other QT-prolonging (eg, on QTc and of therapies for therapies and J. R. L. et of block in a randomized results of the ECG 2019; PubMed Scopus (58) Google Scholar, F. et of a and in healthy PubMed Scopus Google Scholar, Cygankiewicz I. M. The cardiac of treatment in patients with the on arrhythmia, heart rate and PubMed Scopus Google Scholar, M. R. Cardiac from use of a case report and of the Cardiol. PubMed Scopus Google risk of P. J. N. G. Z. related to in 2018; 36: Google risk of M. M. Li S. et on the and potential the of 2017; PubMed Scopus Google Scholar, Y. D. Choi D. of QT in Res 2018; PubMed Scopus Google Scholar, Food and Drug for of information. accessed: May 2020Google Scholar, K. and the risk of cardiovascular Engl J Med. PubMed Scopus Google Scholar, D. F. and the risk of the from data of the FDA PubMed Scopus Google Scholar, Chen et of in cardiovascular Cardiol. 2015; PubMed Scopus Google Scholar, J. and the risk of cardiovascular 27: PubMed Scopus Google risk of J. R. L. et of block in a randomized results of the ECG 2019; PubMed Scopus (58) Google risk of S. C. L. B. Zhang of at and in healthy J 49: PubMed Scopus Google or = not = Open table in a new tab = not = In COVID-19 patients receiving there should be a of risk QT-prolonging COVID-19 therapies, especially their For some recent observational effects of hydroxychloroquine in use is to of randomized trials of and for example, T. et of treatment with hydroxychloroquine or with in patients with COVID-19 in New York 2020; 323: PubMed Scopus Google Scholar of these is to be monitoring should be arrhythmias the of the potential of hydroxychloroquine or other QT-prolonging and in these cases should be and used as Most all predisposing factors for QTc that may arrhythmia should be and the of with an such as long QT syndrome are should be be in case of or that may the to with QT-prolonging that exert a QT-prolonging are to be in an inpatient a 12-lead ECG should be of the patients can be into of or in the of or high-risk QTc of or in the of or patients who are started on of guidance for and the and potential of for coronavirus disease 2020; Full Text Full Text PDF PubMed Scopus Google Scholar patients treated with QT-prolonging may be using MCT (or with of QTc and urgent patients require more

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