1. SYNCOPE Therapy Awareness Presentation

2. The Syncope Challenge
Magnitude
Syncope accounts for 740 ER visits per year, accounting for 237,000 hospitalizations*1
Inpatient Challenge
Approximately half of patients admitted to hospital leave without a diagnosis.2
Patient’s Frustration
In reaching a diagnosis patients see 3 different specialists, undergo 13 tests, and 1/3 have significant associated trauma.3
Cardiac Causes
Cardiac syncope is common, doubles the risk of death, and is associated with a 6-month mortality rate greater than 10%.4
1 Sun BC, et al. Am J Cardiol. May 15, 2004;93(10):
2 Mendu M, et al. Arch Intern Med. 2009;169:
3 Edvardsson N, et al. Europace. 2011;13:
4 Soteriades ES, et al. N Engl J Med. 2002;347:
*Data obtained from National Hospital Ambulatory Medical Care Survey between 1992 to 2000.
Syncope | Therapy Awareness Presentation | March 2017

3. Unexplained Syncope + Cardiac Syncope
Over 50% of Patients
Unknown
34%
Cardiac
abnormal rhythms, structural damage
18%
Neurally
Mediated
vasovagal, carotid sinus, situational
24%
Syncope remains unexplained in approximately 1/3 of cases
Orthostatic/ Drug-induced
ANS failure, medication
11%
Neurologic Seizure, stroke, TIA etc
10%
Source: Linzer M, et al. Ann Intern Med. 1997;126:
Syncope | Therapy Awareness Presentation | March 2017

4. Syncope the cause matters Cardiac syncope:
Carries a 6-month mortality rate of greater than 10%
Doubles the risk of death
Overall Survival of Participants with Syncope According to Cause
Source: Soteriades ES, et al. N Engl J Med. 2002;347: 4
Syncope | Therapy Awareness Presentation | March 2017

5. WRITING COMMITTEE MEMBERS
2017 ACC/AHA/HRS Guideline for the Evaluation and Management of Patients With Syncope
A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines,
and the Heart Rhythm Society
Developed in Collaboration With the American College of Emergency Physicians and Society for Academic Emergency Medicine
Endorsed by the Pediatric and Congenital Electrophysiology Society
WRITING COMMITTEE MEMBERS
Win-Kuang Shen, MD, FACC, FAHA, FHRS, Chair†
Robert S. Sheldon, MD, PhD, FHRS, Vice Chair
David G. Benditt, MD, FACC, FHRS*‡
Mitchell I Cohen, MD, FACC, FHRS ‡
Daniel E. Forman, MD, FACC, FAHA ‡
Zachary D. Goldberger, MD, MS, FACC, FAHA, FHRS ‡
Blair P. Grubb, MD, FACC §
Mohamed H. Hamdan, MD, MBA, FACC, FHRS ‡
Andrew D. Krahn, MD, FHRS*§
Mark S. Link, MD, FACC‡
Brian Olshansky, MD, FACC, FAHA, FHRS ‡
Satish R. Raj, MD, MSc, FACC, FHRS*§
Roopinder Kaur Sandu, MD, MPH ‡
Dan Sorajja, MD ‡
Benjamin C. Sun, MD, MPP, FACEP║
Clyde W. Yancy, MD, MSc, FACC, FAHA ‡
Source: Shen WK, et al.. J Am Coll Cardiol DOI: /j.jacc 5
Syncope | Therapy Awareness Presentation | March 2017

6. Evidence level definitions – NEW Descriptors
Note: types of clinical data qualify level of evidence
i.e. “randomized”/
”non randomized”
Source: Shen WK, et al.. J Am Coll Cardiol DOI: /j.jacc 6
Syncope | Therapy Awareness Presentation | March 2017

7. Syncope Initial Evaluation
Source: Shen WK, et al.. J Am Coll Cardiol DOI: /j.jacc 7
Syncope | Therapy Awareness Presentation | March 2017

8. characteristics IDENTIYING patients most likely to be associated with a cardiac cause
Class
LOE
Recommendation I
B-NR
Evaluation of the cause and assessment for the short- and long-term morbidity and mortality risk of Syncope are recommended
Historical Characteristics Associated with Increased
Probability of Cardiac Causes of Syncope
Older age (>60yr)
Male Sex
Presence of ischemic heart disease, structural heart disease, previous arrhythmias, or reduced ventricular function
Brief (palpitations) or no symptoms prior to loss of consciousness
Occurs with exertion
Occurs in supine position
Low number of events (1 or 2)
Abnormal cardiac examination
Family history of inheritable conditions or premature SCD (<50 yr of age)
Presence of known congenital heart disease
Clinical impact:
Increases physician confidence that cardiac monitoring is needed?? REPLACE???
Source: Shen WK, et al.. J Am Coll Cardiol DOI: /j.jacc 8
Syncope | Therapy Awareness Presentation | March 2017

9. Characterizing Risk score of syncopal patients
Class
LOE
Recommendation I
B-NR
Evaluation of the cause and assessment for the short- and long-term morbidity and mortality risk of syncope are recommended
Short-term (<30 d) risk factors
Long-term (>30d) risk factors
Older age (>60yr)
Male Sex
Palpitations or no symptoms prior to loss of consciousness
Occurs with exertion
Structural heart disease
Heart failure
Cerebrovascular disease
Family history of SCD
Trauma
Bleeding evidence
Persistent abnormal vitals/ECG
Positive troponin
Older age (>60yr)
Male Sex
Absence of nausea/vomiting before syncope
Ventricular arrhythmias detected
Cancer
Structural heart disease
Heart failure
Cerebrovascular disease
Diabetes mellitus
High CHADS2 score
Abnormal ECG
Low GFR (kidney function)
IIb
B-NR
Use of risk stratification scores may be reasonable in the management of patients with syncope
High-risk patients should be considered for cardiac monitoring early in evaluation
Source: Shen WK, et al.. J Am Coll Cardiol DOI: /j.jacc 9
Syncope | Therapy Awareness Presentation | March 2017

10. Syncope Evaluation care pathway
After initial evaluation and if cardiac cause is suspected, cardiac monitoring should be performed – Class I Recommendation
ICMs should be placed in all patients with infrequent symptoms
Source: Shen WK, et al.. J Am Coll Cardiol DOI: /j.jacc 10
Syncope | Therapy Awareness Presentation | March 2017

11. Cardiac monitoring recommendations
Class
LOE
Recommendation I
C-EO
The choice of a specific cardiac monitor should be determined on the basis of the frequency and nature of syncope events.
IIa
B-R
To evaluate selected ambulatory patients with syncope of suspected arrhythmic etiology, an ICM can be useful
B-NR
To evaluate selected ambulatory patients with syncope of suspected arrhythmic etiology, the following external cardiac monitoring approaches can be useful:
Holter monitor
Transtelephonic monitor
External loop recorder
Patch recorder
Mobile cardiac outpatient telemetry
Cardiac monitoring is necessary
Patient selection is based on frequency of symptoms, likelihood of arrhythmic cause and patient characteristics
Randomized clinical trials demonstrate the value of ICM monitoring in syncope patients
Source: Shen WK, et al.. J Am Coll Cardiol DOI: /j.jacc 11
Syncope | Therapy Awareness Presentation | March 2017

12. Monitoring Selection criteria
The right device for the right patient
Holter
Monitors
Extended
Holters
External Loop Recorders
Mobile Cardiac Telemetry
Insertable Cardiac Monitors
Duration
24 – 48 hrs
2-14 days
Up to 1 month
≤3 years
Patient Selection
Daily symptoms
Weekly symptoms
Monthly symptoms
(some up to 6 wks)
Monthly symptoms
Recurrent, infrequent symptoms
Diagnostic choice should be based on frequency of symptoms and nature of syncope events.
Source: Shen WK, et al.. J Am Coll Cardiol DOI: /j.jacc
Syncope | Therapy Awareness Presentation | March 2017

13. ESC SYNCOPE GUIDELINES
RECOMMENDATIONS FOR THE USE OF ICM MONITORING
Class I ICM
Guidelines
Indicated in early phase of evaluation in patients with recurrent syncope of uncertain origin, absence of high risk criteria, and a high likelihood of recurrence within battery longevity of the device
Indicated in high risk individuals in whom comprehensive evaluation did not demonstrate a cause of syncope or lead to a specific treatment
Source: Moya A, el al. Eur Heart Journal. 2009;30:
Syncope | Therapy Awareness Presentation | March 2017

14. NICE CLINICAL SYNCOPE GUIDELINE
DIAGNOSTIC TESTING ACCORDING TO FREQUENCY OF SYMPTOMS
Frequency of Syncope
Suggested ECG Monitoring Technique
Several times a week
24-48h Holter monitoring
Every 1-2 weeks
External loop recorder
Less than once per month
Implantable loop recorder
Source: NICE Clinical Syncope Guideline CG109,
Syncope | Therapy Awareness Presentation | March 2017

15. SYNCOPE GUIDELINES: ARE THEY FOLLOWED?
significant proportion of hcps state they would use monitoring Inconsistent with guidelines
Type of monitor recommended based on the frequency of syncope episodes
Event
ICM
Holter
ICM / ILR
MCOT
EVENT
HOLTER
- Similar results for EU
Frequency of syncope episodes
Based on syncope guidelines, more ICMs should be used for the infrequent episodes
Source: US Syncope Quantitative Research, Medtronic, March 2016, n=200 ER physicians, PCPs, Hospitalists, Neurologists, Cardiologists.
Syncope | Therapy Awareness Presentation | March 2017

16. Reveal LINQ SYSTEM ADVANTAGES
POWERFUL CARDIAC MONITORING
ICMs are underutilized ICMs are recommended by clinical guidelines1,2 ─ yet significantly underutilized
Up to
3 in 4
Patients who met appropriate criteria for ICM implantation
did not receive one3
References:
Task Force for the Diagnosis and Management of Syncope, European Society of Cardiology (ESC), European Heart Rhythm Association (EHRA), et al. Guidelines for the diagnosis and management of syncope (version 2009). Eur Heart J. November 2009;30(21):
The Task Force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC), et al ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. Eur Heart J. Aug. 2013; 34(29):2281–2329 .
Vitale E, Ungar A, Maggi R, et al. Discrepancy between clinical practice and standardized indications for an implantable loop recorder in patients with unexplained syncope. Europace. Oct. 2010; 12(10):
1 Moya A, et al. Eur Heart J. 2009;30:
2 Crawford MH, et al. J Am Coll Cardiol. 1999;34:
3 Vitale E, et al. Europace. 2010;12:
Syncope | Therapy Awareness Presentation | March 2017

17. PATIENTS & HEALTHCARE PROVIDERS
STRUGGLE TO FIND the ANSWER
Patients endure ongoing diagnostic testing and still come away with no answers 3 13
1 in 4
specialists visited on average
Inconclusive tests
Undergo more than 20 tests
Source: Edvardsson N, et al. Europace. 2011;13:
Syncope | Therapy Awareness Presentation | March 2017

18. PATIENT EXPERIENCE
70% of patients had been hospitalized at least once for syncope.
36% of patients had experienced significant trauma in association with a syncopal episode.
Overall, patients had seen an average of 3 different specialists for their syncope.
Source: Edvardsson N, et al. Europace. 2011;13:
Syncope | Therapy Awareness Presentation | March 2017

19. Diagnostic tests performed before reveal™ ICM
PICTURE STUDY
Total recruitment
570 (100%)
Standard ECG
556 (98%)
Echocardiography
490 (86%)
Basic laboratory tests
488 (86%)
Ambulatory ECG monitoring
382 (67%)
In-hospital ECG monitoring
311 (55%)
Exercise testing
297 (52%)
Orthostatic blood pressure measurements
275 (48%)
MRI/CT scan
267 (47%)
Neurological or psychiatric evaluation
270 (47%)
EEG
222 (39%)
Carotid sinus massage
205 (36%)
Tilt test
201 (35%)
Electrophysiology testing
144 (25%)
Coronary angiography
133 (23%)
External loop recording
67 (12%)
ATP test
15 (3%%)
Other Tests
52 (9%)
No tests performed
1 (0%)
The median number of tests performed per patient was 13 (inter-quartile range )
Source: Edvardsson N, et al. Europace. 2011;13:
Syncope | Therapy Awareness Presentation | March 2017

20. Testing Options & YIELD
Syncope Diagnosis
Testing Options & YIELD
Test / Procedure
Yield*
ECG
2-11%1
Holter Monitoring
2%2
External Loop Recorder
20%3
Tilt Table
11%+4,5
EP Study without structural heart disease
11%6
Neurological (CT scan, carotid doppler)
0-4%5
Reveal ICM
78%7
8 Rothman S, et al. J Cardiovasc Electrophysiol. 2007;18:
9 Olson JA, et al. J Cardiovasc Electrophysiol. 2007;18:
7 Edvardsson N, et al. Europace. 2011;13:
*Based on mean diagnosis time of 5.1 mos.2
1 Kapoor WN. Am J Med. 1991;90:
2 Krahn AD, et al. Cardiol Clin. 1997;15:
3 Krahn AD, et al. J Am Coll Cardiol. 2003;42:
4 Kapoor WN. 1990;69:
5 Kapoor WN. JAMA. 1992;268:
6 Linzer M, et al. Ann Intern Med. 1997;127:76-86.
7 Edvardsson N, et al. Europace. 2011;13:
Syncope | Therapy Awareness Presentation | March 2017

21. Icm success in diagnosing patients with syncope
Picture study
570 Patients
Study Design
Investigated the effectiveness of Reveal™ ICM in the diagnosis of unexplained recurrent syncope in everyday clinical practice
Helped inform current guidelines
Conclusion
A Reveal ICM should be implanted rather than later in the evaluation of unexplained syncope
Source: Edvardsson N, et al. Europace. 2011;13:
Syncope | Therapy Awareness Presentation | March 2017

22. SYNCOPE ALGORITHM Flowchart adapted from:
SHD = Structural Heart Disease
CSM = Carotid Sinus Massage
EPS = Electrophysiologic Study
*Provides up to 36 months of continuous monitoring.
This is a general protocol to assist with the management of patients. This is not designed to replace clinical judgment or individual patients needs.
Flowchart adapted from:
Olshansky B. Syncope: Overview and approach to management. In: Grubb B and Olshansky B. eds. Syncope: Mechanisms and Management. 2nd ed. Malden, MA: Blackwell Futura; 2005:1-46.
Krahn AD, Klein GJ, Yee R, Skanes AC. The use of monitoring strategies in patients with unexplained syncope – role of the external and ILR. Clin Auton Res. October 2004;14(Suppl 1):55-61
Raviele A, Alboni P, Sutton D, Kenny RA. Initial evaluation of the syncope patient. In: Benditt D, Blanc J-J, Brignole M, Sutton R, eds. The Evaluation and Treatment of Syncope. Elmsford, NY: Futura. 2003:38-45.
Strickberger SA, Benson DW, Biaggioni I, et al. AHA/ACCF Scientific Statement on the evaluation of syncope: from the American Heart Association Councils on Clinical Cardiology, Cardiovascular Nursing, Cardiovascular Disease in the Young, and Stroke, and the Quality of Care and Outcomes Research Interdisciplinary Working Group; and the American College of Cardiology Foundation: in collaboration with the Heart Rhythm Society: endorsed by the American Autonomic Society. Circulation. January 17, 2006;113(2):
Brignole M, Alboni P, Benditt DG, et al. Guidelines on management (diagnosis and treatment) of syncope – update Europace. November 2004;6(6):
Kaufmann H, Wieling W. Syncope: a clinically guided diagnostic algorithm. Clin Auton Res. October 2004;14 (Suppl 1):87-90.
Syncope | Therapy Awareness Presentation | March 2017

23. Reduce cost with earlier utilization
ICMs ARE A COST-EFFECTIVE DIAGNOSTIC TOOL
Reduce cost with earlier utilization
Multiple studies show ICM monitoring resulted in cost savings in syncope patients compared to conventional testing through fewer tests and hospital admissions.1-4 6
1 Krahn AD, J Am Coll Cardiol.August 6, 2003;42(3):
2 Farwell DJ, Eur Heart J. July 2004;25(14):
3 Davis S, Europace. March 2012;14(3):
4 Providência R, et al. BMC Cardiovasc Disord. May 6, 2014;14:63.
5 Edvardsson N, et al. Europace. February 2011;13(2):
6 Edvardsson N, Europace. July 2015;17(7):
Syncope | Therapy Awareness Presentation | March 2017

24. vs. Economic value REVEAL LINQ ICM AND THE CARE CONTINUUM
Long-term benefits of Reveal LINQ™ ICM Accurate diagnosis and defined care continuum
PATIENT CARE CONTINUUM
NO ICM IMPLANTED
✕ Care continuum is variable or unknown
✕ Further diagnostic testing, with mixed results
✕ Increased costs and inefficient use of resources
✕ Potential loss of patient to follow-up
✕ A “revolving door” experience for patients
ICM IMPLANTED
Accurate diagnosis of cardiac arrhythmia
Timely and informed treatment decisions
Long-term patient care
Broad benefits from remote monitoring with MyCareLink™ Patient Monitor
Identify indicated patients with treatment needs
vs.
Syncope | Therapy Awareness Presentation | March 2017

25. Experience The reveal linq™ advantage
Reveal LINQ™ INSERTABLE CARDIAC MONITOR an overview

26. Reveal LINQ SYSTEM ADVANTAGES
POWERFUL CARDIAC MONITORING
Indications for use
The Reveal LINQ™ insertable cardiac monitor (ICM) is an implantable patient-activated and automatically-activated monitoring system that records subcutaneous ECG and is indicated in the following cases:
Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
Patients who experience transient symptoms such as dizziness, palpitation, syncope, and chest pain, that may suggest a cardiac arrhythmia
The device has not been tested specifically for pediatric use.
Syncope | Therapy Awareness Presentation | March 2017

27. Reveal LINQ™ SYSTEM ADVANTAGES
AN ADVANCED MONITORING SOLUTION
Reveal LINQ ICM
Wireless
MyCareLink™ Patient Monitor
Cellular
CareLink™ Network
& Reports
Solution Enablers
Insertion Tools
Patient Assistant
NEW App-based Reveal
LINQ Mobile Manager
NEW Monitoring Service Solutions
Syncope | Therapy Awareness Presentation | March 2017

28. Reveal LINQ™ SYSTEM ADVANTAGES
REVOLUTIONIZING CARDIAC MONITORING
The smallest, most powerful insertable cardiac monitor One-third the size of a AAA battery (1.2 cc)
Up to a 3-year longevity for long-term monitoring1
MR Conditional at 1.5 and 3.0 Tesla
Minimally invasive, simplified insertion procedure2
96.7% of patients very satisfied or satisfied with Reveal LINQ ICM after insertion3
1 Reference the Reveal LINQ ICM Clinician Manual for usage parameters.
2 Reveal LINQ Usability Study. Medtronic data on file
3 Pürerfellner H, et al. Heart Rhythm. 2015;12:
Syncope | Therapy Awareness Presentation | March 2017

29. Reveal LINQ™ SYSTEM ADVANTAGES
SIMPLE INSERTION PROCEDURE
Best location: 45 degrees to sternum over 4th intercostal space, 2 cm from left edge of sternum
97%
Of physicians found the insertion tool simple and intuitive.1
1 Reveal LINQ Usability Study. Medtronic data on file
Syncope | Therapy Awareness Presentation | March 2017

30. Reveal LINQ™ SYSTEM ADVANTAGES
TRANSFORMING CARDIAC MONITORING
Transforming your ability to diagnose and treat even the most difficult-to-detect arrhythmias
Proven Accuracy
Evidence superiority.1-5
Real-world impact.1,6,7
CLINICAL RIGOR
Proven arrhythmia detection.1,8,9
Informed clinical decisions.
ADVANCED MONITORING
Innovative solutions.
Simplified experience.
1 Medtronic Reveal Publications. Medtronic data on file
2 Sanders P, et al. Heart Rhythm. 2016;13:
3 Sanna T, et al. N Engl J Med. 2014;370:
4 Edvardsson N, et al. Europace. 2011;13:
5 Krahn AD, et al. J Am Coll Cardiol. 2003;42:
6 Rogers J, et al. Presented at American Academy of Neurology, April 2016 [abstract S42.003]. Available at: Accessed April 11, 2016.
7 Ziegler PD, et al. Cerebrovasc Dis. 2015;40:
8 False positive rate comparison. Medtronic data on file
9 Medtronic Reveal AF Publications. Medtronic data on file
Syncope | Therapy Awareness Presentation | March 2017

31. CLINICAL RIGOR EVIDENCE SUPERIORITY. REAL-WORLD IMPACT.
Most Studied ICM
With an evidence portfolio of 500+ published clinical articles and
abstracts1
With an evidence portfolio of 500+ published clinical articles and abstracts1 Across Cryptogenic Stroke, Syncope, and Atrial Fibrillation patient populations8-10 Published in multiple premier journals, including Heart Rhythm, The New England Journal of Medicine and JACC 8,9,11
Most Clinically Validated ICM
Across Cryptogenic Stroke, Syncope, and Atrial Fibrillation
patient populations2-4
Only ICM with Premier Clinical Evidence
Published in multiple premier journals, including Heart Rhythm,
The New England Journal of Medicine, and JACC2,3,5
1 Medtronic Reveal Publications. Medtronic data on file
2 Sanders P, et al. Heart Rhythm. 2016;13:
3 Sanna T, et al. N Engl J Med. 2014;370:
4 Edvardsson N, et al. Europace. 2011;13:
5 Krahn AD, et al. J Am Coll Cardiol. 2003;42:
Syncope | Therapy Awareness Presentation | March 2017

32. TRURHYTHM™ Detection inside
Accuracy evolution
NEW algorithms with
Smart filtering
Self-learning intelligence
Streamlined episode review
for clinic efficiency1,2
TruRhythm™ Detection
PAUSE
BRADY AF
Reveal LINQ™
NEW simplified insertion and tight pocket for better signal
NEW AF algorithm
with increased
accuracy AF
Reveal™ XT
NEW AF algorithm
and improved noise
discrimination
NEW Pause algorithm with diminishing R-wave analysis AF
PAUSE
With FullView ™ Software
Reveal™ XT AF
Industry’s first AF
detection algorithm
Notes for Reps:
Medtronic has been the market leader in developing the most advanced and accurate arrhythmia detection algorithms available.
Our engineers and scientists have continually improved each Reveal-brand ICM, making the detection algorithms better every few years as we introduced new models or enhanced a model’s capabilities with a firmware update.
In 2009, the Reveal brand ICMs contained industry-leading Brady, Pause and Tachy detection algorithms inside an ICM.
In 2009, Medtronic also introduced the world’s first AF detection algorithm inside an ICM, expanding a physician’s use of this important diagnostic tool to one of the hardest to detect and diagnose arrhythmias.
In 2011, Medtronic introduces FullView Software, giving clinicians improved data viewing and collection capabilities. As part of this upgrade to the Reveal XT ICM, Medtronic also improved its AF detection algorithm, and enhanced the noise discrimination algorithm, allowing for ectopy rejection, and introduced a new Pause algorithm with the ability to analyze diminishing R-waves, among other advancements.
In 2014, Medtronic introduced the revolutionary Reveal LINQ ICM, the world’s smallest, and first insertable cardiac monitor. The Reveal LINQ also significantly improved Medtronic’s AF detection algorithm, and improved a clinician’s overall experience with streamlined data management, reporting and patient management.. The Reveal LINQ also introduced daily, automatic wireless transmission of patient’s data from the inserted Reveal LINQ to the Medtronic CareLink network, assuring continuous rhythm information from patients to ensure timely notification of all clinically-relevant arrhythmias.
And today, in 2017, Medtronic brings you TruRhythm™ Detection – the most advanced ICM intelligence available. The TruRhythm algorithms are a device firmware upgrade to the Reveal LINQ ICM. The new algorithms include AF, Brady and Pause sensing, filtering and detection algorithms, including new self-learning intelligence built into the TruRhythm AF detection algorithm. This new suite of algorithms has been designed to simplify ICM data and create a more efficient workflow for clinics.
2009
2011
2014
2017
1 TruRhythm™ Detection Efficiency. Medtronic data on file
2 TruRhythm™ Detection Algorithms. Medtronic data on file
Syncope | Therapy Awareness Presentation | March 2017

33. TRURHYTHM™ INTELLIGENT DETECTION
NEW ALGORITHMS
SMART FILTERING
Self-learning
NEW second sensing filter analyzes rhythms for possible undersensing in Brady and Pause
Exclusive fifth-generation atrial fibrillation algorithm learns and adapts to patient’s rhythm over time
BRADY
PAUSE
& AF
Syncope | Therapy Awareness Presentation | March 2017

34. Innovative solutions. Simplified experience.
Advanced monitoring
Innovative solutions. Simplified experience.
STREAMLINED INSERTION WORK FLOW
ACTIONABLE REPORTS
SIMPLIFIED PATIENT MANAGEMENT
Supported by an enhanced Medtronic CareLink™ network
Industry’s highest diagnostic yields, with actionable reports1-4
Resources to support clinic efficiency and data review
New Medtronic Academy Learning Plan
Simple, minimally invasive outpatient insertion procedure
New Patient Education Resources
New Reveal LINQSM Monitoring Service
New app-based device management with the Reveal LINQ™ Mobile Manager
1 Edvardsson N, et al. Europace. 2011;13:
2 Krahn AD, et al. Am J Cardiol. 1998;82:
3 Krahn AD, et al. Circulation. 1999;99:
4 Crossley GH, et al. J Am Coll Cardiol. 2011;57:
Syncope | Therapy Awareness Presentation | March 2017

35. 13 78% 75% 25% Economic value SYNCOPE Effectively Treat
Clinical impact of Reveal™ ICM in syncope patients
Effectively Treat
Accurately Diagnose 13
Median number of inconclusive tests before ICM was implanted1
78%
Patients that receive a diagnosis following a syncopal event with Reveal™ ICM1
75%
of Reveal-guided diagnoses were found to be cardiac related1
25%
Reveal ICM patients that receive device therapy within 36 months2
1 Edvardsson N, et al. Europace. 2011;13:
2 Medtronic Reveal LINQ Pull through. Medtronic data on file
Syncope | Therapy Awareness Presentation | March 2017

36. SYNCOPE PATIENT IMPACT
Advanced monitoring
SYNCOPE PATIENT IMPACT
William’s story Reveal LINQ™ ICM used to discover non-sustained SVT event
William remembered his fainting spells seemed to come out of nowhere. The first time it happened was just after he stood up to get a second cup of coffee. He was unconscious for 30 seconds while his parents and wife feared he was dead. Another time, he was having dinner while on a cruise ship when, without warning, his head fell forward and he lost consciousness. William experienced an ambulance trip, multiple visits to the hospital and appointments with various physician specialties. Multiple tests showed nothing. Years went by without incident until he was on another family vacation—this time to Paris. As he walked along a cobblestone street with his family, William collapsed. “My face slammed into a cobblestone curb and knocked out my four front teeth. I had a cut under my chin, my mouth was gushing blood, I had a gash over my right eye, and I’d fractured my upper mandible on the left- side of my jaw. I also had hairline fractures of the orbital bones under my eyes.”
William returned to the U.S. for reparative surgery, and to meet with an Electrophysiologist who recommended the Reveal LINQ™ ICM. The device was inserted in February, 2016 and the following August, Dr. Sanchez called William to tell him that an episode was detected. The data showed that, while William slept, he experienced a non-sustained SVT event: 20 heartbeats in a 5-seconds span.
Today, following a successful ablation procedure, William is back to enjoying life. He works out multiple times a week and enjoys traveling with his family, playing basketball, tennis and golf.
This story reflects one person’s experience. Not every person will receive the same results.
Syncope | Therapy Awareness Presentation | March 2017

37. SYNCOPE PATIENT IMPACT
Advanced monitoring
SYNCOPE PATIENT IMPACT
Kymberli’s story Reveal LINQ™ ICM used to discover malignant vasovagal syncope
On a February morning in 2015, Kymberli, the busy mother of four young children prepared for her triplets’ first birthday party. Suddenly, she felt queasy, confused and clammy. She passed out before she could say anything. Kymberli was taken by ambulance to the emergency room. After a CT scan and a 2D echo, she was discharged and sent to a cardiologist. She was given a 30-day event monitor that showed nothing of concern related to her heart. The doctors thought it was possible that stress, dehydration or lack of sleep had triggered the event. Kymberli wasn’t convinced. She made an appointment with an electrophysiologist specializing in the diagnosis and treatment of abnormal heart rhythms. He ordered a cardiac MRI and a stress test, both of which came back normal. Aside from a low heart rate and hypotension she’d had her entire life, Kymberli appeared healthy.
This story reflects one person’s experience. Not every person will receive the same results.
Her doctor recommended Reveal LINQ™ ICM. The device was inserted in June, 2015 and the following November Kymberli blacked out while home alone with the children. The data from Kymberli’s device was transmitted to her doctor’s office. Just minutes after receiving it, they contacted Kymberli and told her to call 911. The data showed Kymberli’s heart had stopped for 19 seconds.
Kymberli was diagnosed with malignant vasovagal syncope and sick sinus syndrome. A pacemaker was implanted to regulate Kymberli’s heart.
“The Reveal LINQ is the reason I’m here today,” says Kymberli. “Without it, my doctor wouldn’t have detected my heart’s 19 second pause. With that information, he could diagnose the malignant form of vasovagal syncope and prevent syncope with a pacemaker. Now I have comfort in knowing I’m OK and that my heart will keep beating.”
Syncope | Therapy Awareness Presentation | March 2017

38. SYNCOPE PATIENT IMPACT
Advanced monitoring
SYNCOPE PATIENT IMPACT
Debbie’s story Reveal™ ICM used to discover a rare form of AT
After Debbie fainted the first time, she didn't think much about it. As a cardiac nurse, she knew there were many reasons people faint. But the fainting continued, and within a couple of months she was passing out three times a day. Her cardiologist decided to give Debbie a Medtronic Reveal insertable cardiac monitor (ICM).
Based on the information from the Reveal ICM, her doctors determined Debbie had a rare, aggressive form of atrial tachycardia (AT) that was very resistant to treatment. She tried new medications. Debbie’s doctors also relied on the Reveal ICM to monitor how her heart responds to the therapy.
With her fainting under better control, Debbie got back to practicing ballet.
She encourages people who experience fainting episodes to make a doctor appointment right away.
Photo shown is not actual patient. This story reflects one person’s experience. Not every person will receive the same results.
Syncope | Therapy Awareness Presentation | March 2017

39. Indications, Safety, and Warnings
If you are located in the United States, please refer to the brief statement below to review applicable indications, safety, and warning information. See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at and/or consult the Medtronic website at medtronic.com.
If you are located outside the United States, see the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.com.
Consult instructions for use at this website. Manuals can be viewed using a current version of any major Internet browser. For best results, use Adobe Acrobat
Reader® with the browser.
Important Reminder: This information is intended only for users in markets where Medtronic products and therapies are approved or available for use as
indicated within the respective product manuals. Content on specific Medtronic products and therapies is not intended for users in markets that do not
have authorization for use.
Reveal LINQ™ LNQ11 Insertable Cardiac Monitor and Patient Assistant
Indications
Reveal LINQ™ LNQ11 Insertable Cardiac Monitor
The Reveal LINQ insertable cardiac monitor is an implantable patient-activated and automatically-activated monitoring system that records subcutaneous ECG and is indicated in the following cases:
Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
Patients who experience transient symptoms such as dizziness, palpitation, syncope, and chest pain, that may suggest a cardiac arrhythmia
This device has not been specifically tested for pediatric use.
Patient Assistant
The Patient Assistant is intended for unsupervised patient use away from a hospital or clinic. The Patient Assistant activates the data management feature in the Reveal™ insertable cardiac monitor to initiate recording of cardiac event data in the implanted device memory.
Contraindications
There are no known contraindications for the implant of the Reveal LINQ insertable cardiac monitor. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically implanted device can be tolerated.
Warnings/Precautions
Patients with the Reveal LINQ insertable cardiac monitor should avoid sources of diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, therapeutic ultrasound, and radiofrequency ablation to avoid electrical reset of the device, and/or inappropriate sensing as described in the Medical procedure and EMI precautions manual. MRI scans should be performed only in a specified MR environment under specified conditions as described in the Reveal LINQ MRI Technical Manual.
Syncope | Therapy Awareness Presentation | March 2017

40. Indications, Safety, and Warnings
Patient Assistant
Operation of the Patient Assistant near sources of electromagnetic interference, such as cellular phones, computer monitors, etc., may adversely affect the performance of this device.
Potential Complications
Potential complications include, but are not limited to, device rejection phenomena (including local tissue reaction), device migration, infection, and erosion through the skin.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Medtronic MyCareLink™ Patient Monitor, Medtronic CareLink™ Network, and CareLink™ Mobile Application
Intended Use The Medtronic MyCareLink™ patient monitor and CareLink™ network are indicated for use in the transfer of patient data from some Medtronic implantable cardiac devices based on physician instructions and as described in the product manual. The CareLink™ mobile application is intended to provide current CareLink network customers access to CareLink network data via a mobile device for their convenience. The CareLink mobile application is not replacing the full workstation, but can be used to review patient data when a physician does not have access to a workstation. These products are not a substitute for appropriate medical attention in the event of an emergency and should only be used as directed by a physician. CareLink network availability and mobile device accessibility may be unavailable at times due to maintenance or updates, or due to coverage being unavailable in your area. Mobile device access to the Internet is required and subject to coverage availability. Standard text message rates apply.
Contraindications
There are no known contraindications.
Warnings and Precautions The MyCareLink patient monitor must only be used for interrogating compatible Medtronic implantable devices.
See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential implications/adverse events. For further information, please call Medtronic at and/or consult the Medtronic website at medtronic.com.
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02/2017
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Syncope | Therapy Awareness Presentation | March 2017