Key Clinical Trials and Mega Cohort Studies in the Area of Remote Monitoring. Lifetime of Patient Care. Lifetime of Patient Care.

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1 Key Clinical Trials and Mega Cohort Studies in the Area of Remote Monitoring Suneet Mittal, MD Director, Electrophysiology Laboratory The Arrhythmia nstitute at The Valley Hospital Ridgewood, NJ; New York, NY August 9, 2016 Disclosures: Consultant to Boston Scientific, LivaNova, Medtronic, Philips Healthcare, and St. Jude Medical Lifetime of Patient Care There are 3 million existing cardiac device patients and 400,000 devices implanted annually. 1 Next Day Clinic MPLANT PATENT CARE Opportunity for better quality of care 1 Lifetime of Patient Care Home Battery Rhythm Sensing/Capture Transtelephonic Monitoring circa, 1970s September

2 Lifetime of Patient Care Home Battery Rhythm Sensing/Capture Battery Rhythm Sensing/Capture Diagnostics Transtelephonic Monitoring circa, 1970s Remote Follow-Up 2002 TTM vs Remote Follow-Up 897 pacemaker patients were randomized to remote follow-up or in-office visits and TTM to determine the time to first diagnosis of a clinically actionable events Clinically actionable events were found, on average, two months earlier in the remote arm than in the control arm Clinically Actionable Events (CAE) Per Year 2% 66% AT/AF episodes >48 h or longer were the 2 nd most frequent CAE reported (after NSVT) Crossley G et al. JACC 2009; 54: Lifetime of Patient Care Home Battery Rhythm Sensing/Capture Battery Rhythm Sensing/Capture Diagnostics Battery Rhythm Sensing/Capture Diagnostics Heart Failure Transtelephonic Monitoring circa, 1970s Remote Follow-Up 2002 Remote Monitoring 2005 September

3 Lifetime of Patient Care There are 3 million existing cardiac device patients and 400,000 devices implanted annually. 1 Hospital ER SNF MR Center Nursing Home Surgery Next Day Clinic Home Hospice Center MPLANT PATENT CARE Opportunity for better quality of care 1 The Promise of Remote Monitoring Device-related Elective replacement indicator (ER) or end of life (EOL) Lead-related Significant Δ in pacing Significant increase in pacing thresholds Significant increase in the % of RV pacing Significant decrease in the % of LV pacing Arrhythmia-related New onset of AT/AF Rapid ventricular rates during ongoing AT/AF Non-sustained or sustained VT/VF, including information about ATP and delivery of CD shocks Heart failure-related TRUST Trial Varma N et al. Circulation 2010; 122: September

4 The COMPAS Trial Hospitalization related to atrial arrhythmias and stroke observed: 6 active pts 18 control pts (OR = 0.33; 95% C: ; p = 0.02) Mabo P et al. EHJ 2011; doi: /eurheart/ehr419 N-TME Study Mortality: 3.4% vs. 8.7% HR 0.36 (95% C: ) P=0.004 Hindricks G et al. Lancet 2014; 384: mpact on Survival Saxon LA et al. Circulation : September

5 Flow Chart of Patient Selection Cohort SJM CD/CRT-D mplants mplant Oct 2009 to Nov 2011 SJM PM/CRT-P mplants mplant Oct 2010 to Nov 2011 Time Period Follow-up to Nov 2012 N = 262,564 RM Adherence RM (high) N = 65,489 25% RM (low) N = 54,684 21% RM (none) N = 142,391 54% Outcomes Mortality Varma N, Mittal S et al. JACC 2015; 65: Study Cohort: Device Types N = 262,564 PM 112,692 32% CD 82,621 43% CRT-P 7,704 3% 23% CRT-D 59,547 Varma N, Mittal S et al. JACC 2015; 65: Mortality ncidence Rates 15 N Deaths % per pt-yr RM Any Mortality ncidence Rates * Per 100,000 pt-year * RM Any RM None Pacemaker 115,076 CRT-P 7,906 CD 85,014 CRT-D 61,475 13,256 12% 1,345 17% 11,652 14% 11,877 19% 47% 3,016 5,365 46% 4,502 8,612 47% 3,020 5,817 48% 4,698 8,593 Varma N, Mittal S et al. JACC 2015; 65: Lower MR across all device types September

6 Probability of Survival Probability of Survival Probability of Survival Probability of Survival Probability of Survival RM Adherence High Low None Survival, All Devices Years from mplant Number Number at Riskat Risk High High 65, , , , Low Low 54, , , , ,081 None None 142, , , , ,996 Varma N, Mittal S et al. JACC 2015; 65: Survival, All Device Types 16 RM High vs. None HR: 2.10 [ ] p<0.001 RM High vs. Low HR: 1.58 [ ] p<0.001 RM Low vs. None HR: 1.32 [ ] p<0.001 Survival, Defibrillators Survival, CD 1.00 Survival, CRT D RM Adherence High 0.75 Low None Years from mplant Number at Number Riskat Risk High High , , , , Low Low , , , , None None , , , ,827 1, RM Adherence High 0.75 Low None Years from mplant Number at Number Risk at Risk High 14, , , , Low 13, , , , None 31, , , , RM High vs. None HR: 2.50 [ ], p<0.010 RM High vs. None HR: 2.42 [ ], p<0.010 RM 6 High RM Low vs. vs. None HR: [ ], [ ], p<0.010 p<0.001 RM 6High RM vs. Low None vs. None HR: HR: [ ], [ ], p<0.010 p< RM High vs. Low HR: 1.40 [ ], p< RM High vs. Low RM High vs. Low HR: 1.4 [ ], p<0.001 RM High vs. Low HR: HR: 1.5 [ ], p<0.010 [ ], p< RM Low vs. None HR: 1.8 [ ], p<0.001 RM Low vs. None HR: 1.6 [ ], p< Survival, Pacemakers Survival, Pacemaker 1.00 Survival, CRT P RM Adherence High 0.75 Low None Years from mplant Number at Number Riskat Risk High High , , , ,217 Low Low , , , ,079 None None , , , , RM Adherence High 0.75 Low None Years from mplant Number at Number Riskat Risk High , , Low , , None , , , RM High vs. None HR: 2.25 [ ], p<0.010 RM High vs. None HR: 2.10 [ ], p<0.010 RM 6 High RM Low vs. vs. None HR: HR: [ ], [ ], p<0.010 p<0.001 RM 6 High RM vs. Low None vs. None HR: HR: [ ], [ ], p<0.010 p< RM High vs. Low HR: 1.59 [ ], p< RM High vs. Low RM High vs. Low HR: 1.6 [ ], p<0.001 RM High vs. Low HR: HR: 1.2 [ ], p<0.111 [ ], p< RM Low vs. None HR: [ ], p<0.001 RM Low vs. None HR: 1.7 [ ], p< September

7 RM and Health Care Use 19 Piccini JP, Mittal S et al. (in review) RM and Health Care Use: All-Cause Hospitalization 20 Piccini JP, Mittal S et al. (in review) RM and Health Care Use: Hospitalization Costs 21 Piccini JP, Mittal S et al. (in review) September

8 RM and Health Care Use 22 For every 100,000 patient-years of monitoring: 9,810 fewer hospitalizations 119,000 fewer days in the hospital >$370,000,000 less payments to the hospital Piccini JP, Mittal S et al. (in review) Early nitiation of RM 23 Mittal S et al. JCE 2016; 46: HRS RM Consensus (Circa 2015) Heart Rhythm 2015; 12 (7): e69-e100 September

9 HRS RM Consensus All patents with CEDs should be offered RM as part of the standard follow-up management strategy (Class ; LOE: A) A strategy of remote CED monitoring and interrogation, combined with at least annual inperson evaluation, is recommended in preference to a calendar-based schedule of in-person CED evaluation alone (Class ; LOE: A) t may be beneficial to initiate RM within 2 weeks following CED implant (Class A; LOE: C) September

10 8/5/ Consensus Statement: Remote nterrogation & monitoring of Cardiovascular mplantable Electronic Devices HRS / ACC / AHA / EHRA / APHRS / SOLAECE / PACES David Slotwiner,MD, FHRS, FACC (Chair), Niraj Varma,MD, PhD, FRCP (Co-chair) Renato Pietro Ricci, MD ACC/AHA Clinical Practice Guideline Methodology Class (strength) of recommendation Level (quality) of evidence Class : Strong Benefits >>> Risks Class a: Moderate Benefits >> Risks Class b: Weak Benefits Risks Class : No Benefit moderate Benefit = Risk Class : Harm Risk > Benefit Level A: High-quality Strong Level B-R Randomized Level B-NR Nonrandomized Level C-LD Limited Data Level C-EO Expert Opinion ACCF/AHA Clinical Practice Guideline Methodology Summit ReportA Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines: Journal of the American College of Cardiology, v. 61, p Consensus Statement Device Monitoring A strategy of remote CED monitoring and interrogation, combined with at least annual PE, is recommended over a calendar-based schedule of in-person CED evaluation alone (when technically feasible) Class of Recommendation Level of Evidence A 1

11 8/5/2016 Consensus Statement Device Monitoring A strategy of remote CED monitoring and interrogation, combined with at least annual PE, is recommended over a calendar-based schedule of in-person CED evaluation alone (when technically feasible) Class of Recommendation Level of Evidence All patients with CEDs should be offered RM as part of the standard follow-up management strategy A A Consensus Statement Device Monitoring A strategy of remote CED monitoring and interrogation, combined with at least annual PE, is recommended over a calendar-based schedule of in-person CED evaluation alone (when technically feasible) Class of Recommendation Level of Evidence All patients with CEDs should be offered RM as part of the standard follow-up management strategy A Before implementing RM, it is recommended that each patient be educated about the nature of RM, their responsibilities and expectations, potential benefits, and limitations. The occurrence of this discussion should be documented in the medical record A E Consensus Statement Device Monitoring A strategy of remote CED monitoring and interrogation, combined with at least annual PE, is recommended over a calendar-based schedule of in-person CED evaluation alone (when technically feasible) Class of Recommendation Level of Evidence All patients with CEDs should be offered RM as part of the standard follow-up management strategy A Before implementing RM, it is recommended that each patient be educated about the nature of RM, their responsibilities and expectations, potential benefits, and limitations. The occurrence of this discussion should be documented in the medical record t is recommended that all CEDs be checked through direct patient contact 2 12 weeks post implantation E A E 2

12 8/5/2016 Consensus Statement Device Monitoring A strategy of remote CED monitoring and interrogation, combined with at least annual PE, is recommended over a calendar-based schedule of in-person CED evaluation alone (when technically feasible) Class of Recommendation Level of Evidence All patients with CEDs should be offered RM as part of the standard follow-up management strategy A Before implementing RM, it is recommended that each patient be educated about the nature of RM, their responsibilities and expectations, potential benefits, and limitations. The occurrence of this discussion should be documented in the medical record t is recommended that all CEDs be checked through direct patient contact 2 12 weeks post implantation E t may be beneficial to initiate RM within the 2 weeks of CED implantation a C A E Consensus Statement Device Monitoring All patients with an implantable loop recorder with wireless data transfer capability should be enrolled in an RM program, given the daily availability of diagnostic data Class of Recommendation Level of Evidence E Consensus Statement Device Monitoring All patients with an implantable loop recorder with wireless data transfer capability should be enrolled in an RM program, given the daily availability of diagnostic data t is recommended that health care professionals responsible for interpreting RM transmissions and who are involved in subsequent patient management decisions have the same qualifications as those performing in-clinic assessments and should ideally possess ABM CCE or BHRE certification for device follow-up or equivalent experience Class of Recommendation Level of Evidence E E 3

13 8/5/2016 Consensus Statement Device Monitoring All patients with an implantable loop recorder with wireless data transfer capability should be enrolled in an RM program, given the daily availability of diagnostic data t is recommended that health care professionals responsible for interpreting RM transmissions and who are involved in subsequent patient management decisions have the same qualifications as those performing in-clinic assessments and should ideally possess ABM CCE or BHRE certification for device follow-up or equivalent experience t is recommended that RM programs develop and document appropriate policies and procedures to govern program operations, the roles and responsibilities of those involved in the program, and the expected timelines for providing service Class of Recommendation Level of Evidence E E E Consensus Statement Device & Disease Management Class of Recommendation Level of Evidence RM should be performed for surveillance of lead function and battery conservation A Consensus Statement Device & Disease Management Class of Recommendation Level of Evidence RM should be performed for surveillance of lead function and battery conservation A Patients with a CED component that has been recalled or is on advisory should be enrolled in RM to enable early detection of actionable events E 4

14 8/5/2016 Consensus Statement Device & Disease Management Class of Recommendation Level of Evidence RM should be performed for surveillance of lead function and battery conservation A Patients with a CED component that has been recalled or is on advisory should be enrolled in RM to enable early detection of actionable events RM is useful to reduce the incidence of inappropriate CD shocks B-R E Consensus Statement Device & Disease Management Class of Recommendation Level of Evidence RM should be performed for surveillance of lead function and battery conservation A Patients with a CED component that has been recalled or is on advisory should be enrolled in RM to enable early detection of actionable events RM is useful to reduce the incidence of inappropriate CD shocks B-R RM is useful for the early detection and quantification of atrial fibrillation A E Consensus Statement Device & Disease Management Class of Recommendation Level of Evidence RM should be performed for surveillance of lead function and battery conservation A Patients with a CED component that has been recalled or is on advisory should be enrolled in RM to enable early detection of actionable events RM is useful to reduce the incidence of inappropriate CD shocks B-R RM is useful for the early detection and quantification of atrial fibrillation A The effectiveness of RM for thoracic impedance alone or combined with other diagnostics to manage congestive heart failure is currently uncertain b E C 5

15 8/5/2016 Remote Monitoring is the standard of care and should be offered to all patients with CEDs 6

16 7/29/2016 Remote Monitoring Workflow Challenges and Opportunities? Colin Movsowitz, MBChB, FACC Director of Electrophysiology Einstein Medical Center Montgomery My Disclosures Biotronik Consultant and Speaker Saint Jude Medical Consultant and Speaker Boston Scientific Consultant Ambucor Consultant Challenges: Acceptance Patients and Physicians Remote Monitoring: Paradigm Shift in the Management of patients with CEDs End of Well Baby in-person visits Alert Driven visits Cardiol Clin )

17 7/29/2016 Challenges: New Workflow Virtual patient Connectivity to the nternet Compliance Cost Copays High deductables Streaming data Scheduled Unscheduled Alerts Litigation Challenges: nfrastructure Appreciate the need for infrastructure AHP alone cannot handle this workflow AHP Hiring and retaining trained staff AHP Technicians Challenges: EMR and nteroperability Data vs. nformation mplantable Devices LRs Pacemakers CDS EMR Raw Data nformation 2

18 7/29/2016 Solutions: Acceptance Education Physicians [nternists, cardiologists, EPs] Guidelines HRS Consensus Statement Journals VuMedi Patients Pre-op in the office in consultation At the bedside At wound check Two way communicator (future) Solutions: New Workflow Connectivity Compliance Daily data transmission Proactive compliance management Contract Two way communicator (future) 3

19 7/29/2016 Solutions: nfrastructure n-house coordinated team Technician [triage] AHP [clinical oversight/consent] Scheduler [compliance] Biller [understands coding RM] T technical staff [bridging nternet and EMR with common language] Physician Solutions: nfrastructure Outsource: Shared labor force Scottcare/Ambucor Work Flow J nterv Card Electrophysiol. 2011;31(1):

20 8/9/2016 The Patient with an mplantable Cardiac Device: mproving Outcomes Through the Use of Remote Monitoring The Use of Remote Device nterrogators E. Martin Kloosterman, MD, FACC, FHRS Boca Raton Regional Hospital Director of the Lynn Heart and Vascular nstitute Assistant Professor, Florida Atlantic University Disclaimer Dr. Kloosterman receives modest honoraria as a consultant, proctor, and speaker from the following companies: Boston Scientific Medtronic St. Jude Medical PREMSE: f we can control a robot in Mars. We can certainly control a pacemaker in Boca. 1

21 8/9/ min 2.3 min. 41 consecutive patients/devices were successfully evaluated: 29 were CDs and 12 were pacemakers (DDD CD: 17; VV CD: 5; DDD BV CD: 5, VV BV CD: 2; DDD PM; 11 DDD BV PM: 1). Thirty-three devices were evaluated in the ER and eight in the OR. mean real remote, real mobile, real time, device management. How many of you would feel comfortable managing a cardiac device remotely real time? Of those brave ones, how many of you would be willing to be available 24/7 for remote real time cardiac device management? Limitations Regulatory (information security, HPPA, etc.) Real time service model Scale, Technical and Communication protocols Conventional Bedside Programmer Expert user required at bedside Limited availability One on one care Contributing Factors to Service Model Evolution Exponential growth of devices. Limited / inefficient man power. Remote Device nterrogators Time constrains for clinic / office and CareLink hospital Express checks. 8/2012 Latitude Consult 4/2014 Device check automation (self-check). Home Remote Monitoring CareLink 2002 Latitude 2005 Merlin 2008 Biotronik 2012 ONE patient per transmitter ONE clinic assigned for f/u. Remote nterrogation 24/7 availability Concept of scale Growing diagnostic data (Device activity, Arrhythmia, Heart Failure, etc.) ANY patient can use the transmitter. DEVCE COMPANY ONE Hospital account assigned. SERVCE Advances in communications and electronic medical data. Allows multiple users (different level of expertise) Concept of response time Concept of consistency Concept of scale 2

22 8/9/2016 REMOTE DEVCE NTERROGATORS LOCATONS to CONSDER Pre / Post Op Emergency Room Remote Technical Support at the Point-of-Care Hospital LATTUDE Consult Communicator LATTUDE Consult Technical Services Radiology Satellite Facility Technical Review Simple to Use Focused Device Report Five Metrics 2014 ED Arrival to ED Departure Admitted Patients (Benchmark = 175 min) Admit Decision to ED Departure Admitted Patients (Benchmark = 42 min) ED Arrival to ED Departure (Discharged from ED) ED Patients Only (Benchmark = 93 min) ED Arrival to Diagnostic Evaluation ED Patients Only (Benchmark = 14 min) ED Arrival to Pain Medication Administration ED Patients Only (For Long Bone Fractures) (Benchmark = 36 min) ED Arrival to ED Departure Admitted Patients Time from ED presentation to discharge or transfer to an inpatient unit. Benchmark: minutes 3

23 8/9/2016 Example of Remote nterrogator Service Layout CareLink Express NURSE PATENT Physician ER OR Floor COMPANY REP. For back up Cardiologist EP mprove efficiencies with predictable, quality service. PRE-CARELNK EXPRESS SERVCE Sample of Hospital device check variability 1 POST-CARELNK EXPRESS SERVCE Predictable time-to-diagnostic report 2 84 min Consistent Predictable Quality Service Consistent Predictable Quality Service CareLink Express Service helps reduce variability in device check response time. Consistent Predictable Quality Service 1 Pre-CareLink Express pilot data collected in 5 Medtronic districts for 4 consecutive weeks. Results may vary. ²Medtronic CareLink Express Pilot Summary (June 1, December 31, 2012). Boca Raton Regional Hospital CareLink Express Experience 4

24 8/9/2016 CareLink Express ER case. 86 y/o WM h/o CMP, s/p CABG, EF 30%, Atrial Fibrillation, s/p CD; presents to the EMR with c/o near syncope. No CP, no SOB, no palpitations. Patient: Presents with atrial arrhythmia on current EGM, Cardiac Compass/Arrhythmia summary suggest chronic arrhythmia. Ventricular paced 23.5% 2 Supraventricular tachycardia detections noted, therapy withheld. EGM s provided for physician review to assess possible Ventricular tachycardia. Battery good. No atrial capture management data due to atrial arrhythmia. Ventricular capture management data within safety margin. Sensing/impedances within safety margin. Optivol fluid index slightly elevated, Heart Failure Management report included for review. Feel free to contact me if you need any additional information. 10:50 Communicators (n = 53) installed in 42 hospital facilities. (May 2014 March 2015) Most common location: Emergency Dpt. (n= 32/ 60 %); PACU (n =145/ 28 %). 509 transmissions (median duration of facility interrogator availability was 4 month) Only 53 (10 %) of the 509 transmissions were classified as urgent. Clinicians had access to full technical consultation in 15 min in 89 % of instances. 130 (26%) CED further evaluation or reprogramming was needed. Conclusion: Our data demonstrate the feasibility of a new diagnosis-only, remote interrogation device and remote evaluation process for the interrogation of CEDs in an inhospital environment. Cardiac Devices Remote nterrogation nitial Experience at Boca Raton Regional Hospital #1 US Transmission Volume (400 beds 4 Units) Number of US CareLink Express active sites = 327 Boca Raton s # of CLE transmissions to date = 998 #2 Global Transmission Volume (#1=2114 transmissions; 900 beds 22 Units) Number of OUS CareLink Express active sites = 105 Global number of CLE transmissions to date, 432 sites = 27,838 #1 Globally in Utilization Rate (#1=2114 transmissions; 900 beds 22 Units vs. BRRH: 998 transm. 400 beds 4 Units ) Data through: 1/1/ /30/2015 5

25 8/9/2016 Transmissions Working Hours Boca Raton Regional Hospital (400 beds / 4 nterrogators) Remote Device nterrogators Usage 61% (1087) 39% (685) Regular Business Hours 8 am 5 PM After hours and Weekends Total transmissions n:1773 (8/2013-7/2016) Transmissions Location Distribution Boca Raton Regional Hospital (400 beds / 4 nterrogators) Remote Device nterrogators Usage 9 th Fl. ER 17% (310) + others 7% (128) Tele 2 nd Floor 15% (260) Tele 5 th Floor 20% (369) Tele 4 th Floor 40% (706) Total transmissions n:1773 (8/2013-7/2016) Transmissions Devices Distribution Boca Raton Regional Hospital (400 beds / 4 nterrogators) Remote Device nterrogators Usage *CM: mplantable Cardiac Monitor CM* 5% (86) Tachy Therapy CD+BV Brady Therapy 35% (628) 60% (1059) Total transmissions n:1773 (8/2013-7/2016) 6

26 8/9/2016 How and Who Gets the nterrogation Reports? Shortens time to follow up for the immediate care team, provides convenient access to device information. nterrogation without programmer at: Emergency Department, Pre-op/PACU, Satellite Clinic etc. Company Service System Fax Report Report Report contains: Contact info of site and device clinic Summary Report Freeze capture Episodes summary Most recent VT/VF episode + SEGM Diagnostics summary Parameters summary Reports ed to device professional(s) for remote consultation Transmission to Company Remote Monitoring Site Mobile Alerts Notification Transmission also sent to Company Remote Monitoring Site if patient is enrolled. Alerts delivered via mobile notification MerlinOnDemand Pending FDA approval Future uses of Remote Device nterrogators REMOTE CARDAC DEVCE MANAGEMENT STUDY WORK FLOW 11 minutes #100 pts. c c 3 7 minutes 7 #30 pts. The Journal of nnovations in Cardiac Rhythm Management, 7 (2016),

27 8/9/2016 CARDAC DEVCE MANAGEMENT in the CARDOLOGST OFFCE SERVCE MODEL SCHEDULNG EXAMPLE Closed scheduled = MONDAY 1 TUESDAY 2 WEDNESDAY3 THURSDAY = Open scheduled Conventional Company s Technician Supported Model FRDAY 5 SATURDAY SUNDAY MONDAY Remote On-line and Real-time nterrogation Guided Reprogramming TUESDAY 7 Unscheduled check may take ~1hour WEDNESDAY8 THURSDAY 9 2 FRDAY 10 = 15 SATURDAY SUNDAY 15= Keys to Establish a Successful Remote Device nterrogator Program Understand, Cost Paradigm Change Spend to Save (overall minimal cost) Understand, Not one size fits all. t helps to identify a physician to champion the program in your institution. Discuss with the device company team your institution s professional characteristics to establish a strategy and layout that better suits your needs. How and Who? The system allows for many individuals to order a device check. Not all of them will have the same level of understanding of a report; communications lines with the specialists and the local device company team should be clearly established. Keep in mind Critical Mass. The sporadic ER check may fall short of what the system can bring. Consider expanding to involved cardiac areas OR, CU s and telemetry. Floating teams, i.e. ECG technicians, can cover the whole hospital needs. The Patient with an mplantable Cardiac Device: mproving Outcomes Through the Use of Remote Monitoring The Use of Remote Device nterrogators E. Martin Kloosterman, MD, FACC, FHRS Boca Raton Regional Hospital Director of the Lynn Heart and Vascular nstitute Assistant Professor, Florida Atlantic University 8