REMOTE MONITORING REMOTE MONITORING

OF OF

IMPLANTABLE CARDIAC IMPLANTABLE CARDIAC

DEVICESDEVICES

NP Forum April 8, 2016NP Forum April 8, 2016

Kathy Paradon,RN, CNEKathy Paradon,RN, CNE

Cardiac Device ClinicCardiac Device Clinic

CK Hui Heart CentreCK Hui Heart Centre

Types of DevicesTypes of Devices

�� PacemakersPacemakers

•• BradyarrhythmiasBradyarrhythmias

�� Implantable Cardioverter DefibrillatorsImplantable Cardioverter Defibrillators

•• Tachyarrhythmias Tachyarrhythmias –– VT, VFVT, VF

�� Cardiac Resynchronization Therapy (CRT)Cardiac Resynchronization Therapy (CRT)

•• PacemakersPacemakers

•• DefibrillatorsDefibrillators

�� Cardiac MonitorsCardiac Monitors

•• Syncopy Syncopy

•• PalpitationsPalpitations

Evolution of Evolution of

Cardiac Implantable DevicesCardiac Implantable Devices

Pacing since 1958Implantable Cardioverter Defibrillator 1988Cardiac Resynchronization Therapy 2000

Increasing complexity of device therapies and diagnostic data collection

2007 2007

Implants and FollowImplants and Follow--up visitsup visits

0

500,000

1,000,000

1,500,000

2,000,000

2,500,000

North

America

Implants

Europe

Implants

North

America

F/U

Europe

F/U

Pacemaker

ICD

CRT

©2008 Heart Rhythm Society and European Heart Rhythm Association Expert Consensus on Monitoring of CIEDs, Heart Rhythm, June 2008

CK Hui Implants and FU

0

500

1000

1500

2000

2500

3000

PM implants ICD implants PM f/u ICD f/u

2009

2010

2011

2012

2013

2014

2015

Cardiac Device Patient ReferralCardiac Device Patient Referral

Goals of Cardiac Device Monitoring Goals of Cardiac Device Monitoring

�� Patient RelatedPatient Related•• Optimize ptOptimize pt’’s QOLs QOL

•• Optimize device functions to meet ptOptimize device functions to meet pt’’s clinical needss clinical needs

•• ID ptID pt’’s at risk related device safety notices/advisoriess at risk related device safety notices/advisories

•• Triage nonTriage non--device related health problemsdevice related health problems

�� Cardiac Device ManagementCardiac Device Management•• Assess and document appropriate device functionAssess and document appropriate device function

•• ID and correct abnormal device behaviourID and correct abnormal device behaviour

•• Maximize device longevityMaximize device longevity

•• ID devices nearing EOL, impending lead failure, and organize ID devices nearing EOL, impending lead failure, and organize

device replacement device replacement

Goals of Cardiac Device MonitoringGoals of Cardiac Device Monitoring

�� Disease ManagementDisease Management•• Document arrhythmias, correlate with pt symptoms, Document arrhythmias, correlate with pt symptoms,

determine appropriate device functions in response to determine appropriate device functions in response to

arrhythmiasarrhythmias

�� Atrial fibrillation, VTAtrial fibrillation, VT

•• Document diagnostic information relating to ptDocument diagnostic information relating to pt’’s condition s condition

�� HR histograms, pt activity, optivol, sleep apneaHR histograms, pt activity, optivol, sleep apnea

•• Monitor response to therapyMonitor response to therapy

�� CommunicationCommunication•• Maintain patient databaseMaintain patient database

•• Communicate to patient and healthcare providers Communicate to patient and healthcare providers �� Cardiac device and disease related informationCardiac device and disease related information

•• Provide technical expertise Provide technical expertise �� Colleagues, patients and communityColleagues, patients and community

Traditional FollowTraditional Follow--upup

�� Treatment of patients with CIEDs requires onTreatment of patients with CIEDs requires on--

going f/u after device implantationgoing f/u after device implantation

�� Device FollowDevice Follow--up Clinic up Clinic

•• Hospital based or physician officeHospital based or physician office

�� Designated space and equipment for CIED Designated space and equipment for CIED

assessment and managementassessment and management

•• Specially trained physicians and staffSpecially trained physicians and staff

•• Policies and procedures for Cardiac Device Policies and procedures for Cardiac Device

managementmanagement

�� Type of visitType of visit

•• Face to Face inFace to Face in--clinic visitsclinic visits

•• TransTrans--Telephonic Monitoring (1970Telephonic Monitoring (1970’’s)s)

InIn--clinic Visitclinic Visit

TransTrans--Telephonic MonitoringTelephonic Monitoring�� Limited to pacemaker followLimited to pacemaker follow--upup

�� Assessment of paced and nonAssessment of paced and non--paced rhythm and mode paced rhythm and mode

�� Magnet and nonMagnet and non--magnet pacing rates and modesmagnet pacing rates and modes

�� Provides a brief snapshot of the cardiac rhythm and may not Provides a brief snapshot of the cardiac rhythm and may not

detect intermittent problemsdetect intermittent problems

�� Used if patient condition does not permit inUsed if patient condition does not permit in--clinic f/u but clinic f/u but

should not be the sole means of pacemaker f/ushould not be the sole means of pacemaker f/u

�� Can be useful for frequent f/u of pacemakers nearing battery Can be useful for frequent f/u of pacemakers nearing battery

replacementreplacement

TTM RecordingTTM Recording

FollowFollow--up Frequencyup Frequency

�� Acute (PM, ICD, CRT)Acute (PM, ICD, CRT)

•• 1 month and 3 months 1 month and 3 months

post implant post implant –– in clinicin clinic

�� MaintenanceMaintenance

•• Every 6Every 6--12 months12 months

�� Intensified f/uIntensified f/u

•• Every 1Every 1--3 months3 months�� Near device EOL to Near device EOL to

device replacementdevice replacement

�� Device advisory/safety Device advisory/safety

alertsalerts

�� Patient RelatedPatient Related

•• Stability of rhythm and symptomsStability of rhythm and symptoms

•• Changes in medical therapiesChanges in medical therapies

•• Stability of thresholdsStability of thresholds

�� Device RelatedDevice Related

•• Type of deviceType of device

•• Overall historical performance of Overall historical performance of

the device the device

•• Age of the deviceAge of the device

•• Assessment of device therapies and Assessment of device therapies and

diagnostic datadiagnostic data

�� Disease RelatedDisease Related

•• Frequency and severity of Frequency and severity of

symptomssymptoms

•• Changes in cardiovascular therapyChanges in cardiovascular therapy

Remote MonitoringRemote Monitoring

�� Technology first introduced in 1990sTechnology first introduced in 1990s•• WandWand--based RF to transfer databased RF to transfer data

•• 2001 wireless RF transmission of data2001 wireless RF transmission of data

�� Remote interrogationRemote interrogation•• Scheduled transmission of dataScheduled transmission of data

•• Same info obtained during inSame info obtained during in--clinic visitsclinic visits

�� Remote monitoringRemote monitoring•• Automated transmission of data based on specified Automated transmission of data based on specified

alerts related to device function and clinical events alerts related to device function and clinical events

Remote Monitoring DevicesRemote Monitoring Devices

Remote MonitoringRemote Monitoring

Innovative Use of RMInnovative Use of RM

Medtronic Carelink ExpressMedtronic Carelink Express

�� Can be used in ER or Can be used in ER or

OR setting or hospitals OR setting or hospitals

without a device clinic without a device clinic

(kiosk)(kiosk)

�� Not matched to an Not matched to an

individual deviceindividual device

�� Data transmitted and Data transmitted and

can be reviewed by can be reviewed by

device clinic device clinic

staff/physician staff/physician

Benefits of Remote MonitoringBenefits of Remote Monitoring�� Patient safetyPatient safety

•• Earlier detection of arrhythmias or clinical eventsEarlier detection of arrhythmias or clinical events

�� Atrial fib, VT Atrial fib, VT

�� Worsening Heart failure (HFC)Worsening Heart failure (HFC)

•• Enhanced device monitoringEnhanced device monitoring

�� Early detection of device/lead malfunctionsEarly detection of device/lead malfunctions

�� Reduction of inappropriate shocksReduction of inappropriate shocks

�� Device advisory/recall Device advisory/recall

�� Improved clinic efficiencyImproved clinic efficiency

•• Less time needed for interrogation/followLess time needed for interrogation/follow--upup

•• Increased capacityIncreased capacity

�� Patient convenience/satisfactionPatient convenience/satisfaction

•• Less travel/parking expensesLess travel/parking expenses

•• Less missed work timeLess missed work time

•• Easy to useEasy to use

�� May improve compliance for followMay improve compliance for follow--upup

Disadvantages of RMDisadvantages of RM

�� No ability to testing capture/sensingNo ability to testing capture/sensing

•• Use of device automatic functions can Use of device automatic functions can

provide information about changes to provide information about changes to

capture and sensingcapture and sensing

�� No ability, at present, to program or No ability, at present, to program or

adjust device settingsadjust device settings

•• Patient needs to come to clinic inPatient needs to come to clinic in--

person for any device adjustmentsperson for any device adjustments

Implementation of RMImplementation of RM•• Privacy of informationPrivacy of information--provincial approval for AHSprovincial approval for AHS

�� PIA for each RM/CIED manufacturerPIA for each RM/CIED manufacturer

�� Device encrypted data maintained in servers outside of CanadaDevice encrypted data maintained in servers outside of Canada

�� Secure Website Secure Website –– restricted access username/passwordrestricted access username/password

•• IT to set up link for data transfer into Device Clinic databasesIT to set up link for data transfer into Device Clinic databases

•• Device clinic guidelines for followDevice clinic guidelines for follow--up, data managementup, data management

•• Staff trainingStaff training

•• Patient education and enrollmentPatient education and enrollment�� Determine eligibility for remote monitoringDetermine eligibility for remote monitoring

•• Access to landline, internet, or cell phone receptionAccess to landline, internet, or cell phone reception

•• Patient /family or caregiver able to understand instructionsPatient /family or caregiver able to understand instructions

�� Patient consent Patient consent –– data storagedata storage

�� Patient contract/agreement for use of remote monitorPatient contract/agreement for use of remote monitor

�� Demonstration of the remote monitorDemonstration of the remote monitor

�� Enroll patient on websiteEnroll patient on website

�� Order remote monitor or assign from clinicOrder remote monitor or assign from clinic

•• Patient sets up monitor at homePatient sets up monitor at home�� Begin transmission processBegin transmission process

CarelinkCarelink WebsiteWebsite

Transmissions/AlertsTransmissions/Alerts

Roles of the Team MembersRoles of the Team Members

�� PatientPatient

•• Use the monitor as instructed (contract/agreement)Use the monitor as instructed (contract/agreement)�� Not for replacement of emergency careNot for replacement of emergency care

�� Transmit only when instructed Transmit only when instructed •• Scheduled or patient initiated transmissionsScheduled or patient initiated transmissions

•• Notify clinic of address changes/travelNotify clinic of address changes/travel

�� Clinic staffClinic staff

•• Dedicated personnel for timely review/reporting of Dedicated personnel for timely review/reporting of

transmission datatransmission data

•• Timely communication with patient and relevant healthcare Timely communication with patient and relevant healthcare

providers regarding transmission data and followproviders regarding transmission data and follow--up planup plan

�� PhysicianPhysician

•• Review and signReview and sign--off of documentation regarding off of documentation regarding

transmission data.transmission data.

Roles of the Team MembersRoles of the Team Members

�� DeviceDevice ManufacturersManufacturers

•• Development of RM technologyDevelopment of RM technology

•• Informing clinic staff of RM disruptions/changesInforming clinic staff of RM disruptions/changes

•• Informing clinic staff of alerts/advisories/recallsInforming clinic staff of alerts/advisories/recalls

•• Training of clinic staff in the use of RMTraining of clinic staff in the use of RM

•• Maintenance of secure and encrypted data serversMaintenance of secure and encrypted data servers

Where does RM fit in?Where does RM fit in?

�� New standard of care for Cardiac Device patientsNew standard of care for Cardiac Device patients

�� Adjunct to inAdjunct to in--clinic followclinic follow--upup

•• Alternating 1:1 RM with inAlternating 1:1 RM with in--clinic clinic f/uf/u

•• Intensified followIntensified follow--up for aging up for aging

devices/alerts/advisoriesdevices/alerts/advisories

�� Specialty clinics Specialty clinics –– Heart Function ClinicHeart Function Clinic

•• Access to device diagnostic data for HF Access to device diagnostic data for HF

management and monitoring of medical management and monitoring of medical

therapytherapy

WhatWhat’’s Next?s Next?

�� Remote ProgrammingRemote Programming

•• Technology already existsTechnology already exists

•• Need to ensure patient safetyNeed to ensure patient safety

•• Research Studies underwayResearch Studies underway

THANKTHANK--YOUYOU