this is the new powerpoint template...presentation. agenda epidemiology ... wickramasinghek, et al....

Reveal LINQTM

Insertable Cardiac Monitoring SystemReveal LINQTM

Insertable Cardiac Monitoring SystemCRYPTOGENIC STROKE

THERAPY AWARENESS PRESENTATION

AGENDA

Epidemiology

Diagnosis & Monitoring Strategies

Evidence

Guidelines

Reveal LINQ™ System

Cryptogenic Stroke Care Pathway

Patient Case Study

EPIDEMIOLOGY

STROKE AS A HEALTHCARE ISSUE

Cryptogenic Stroke Therapy Awareness

Wilkins E, Wilson L, Wickramasinghe K, et al. European Cardiovascular Disease Statistics 2017 edition. Eur Heart Network 2017:192

4

IN EUROPE

1.6MILLIONSTROKESOCCUREACH YEAR

STROKEIS THE

2ND

MOSTCOMMONCAUSEOF DEATH

THE LEADINGCAUSE OFDISABILITYIN ADULTS

DISABILITY ASSOCIATED WITH STROKE

Go AS, et al. Circulation. 2013;127:e6-e245.

50

30

4635

1926 26

0

20

40

60

80

100

Remaininghemiparesis

Unable to walkwithout assistance

Cognitive deficits Depressivesymptoms

Aphasia Dependent onothers

Institutionalized

Perc

ent

Cryptogenic Stroke Therapy Awareness5

RECURRENT STROKE RATE AMONG PATIENTS DISCHARGED WITH A PRIMARY DIAGNOSIS OF STROKE

Feng W, et al. Neurology. 2010;74:588–593.

%

1.8

5

8

18.1

0

5

10

15

20

1 month 6 months 1 year 4 years

Rec

urre

nt S

tro

ke R

ate

(%) %


RISK FOR STROKE IN PATIENTS WITH AF


ATRIALFIBRILLATIONIS A COMMONARRHYTHMIATHAT MAY BEAT THE ORIGINOF A STROKE

RISK FOR STROKE IN PATIENTS WITH AF

1 Wolf PA, et al. Arch Intern Med. 1987;147:1561-1564.2 Lin HJ, et al. Stroke. 1996; 27:1760-1764.3 Stroke Prevention in Atrial Fibrillation Study. Circulation. 1991;84:527-539.

5-FOLDincrease in ischemic stroke risk for AF patients.1

2Xmore likely for AF-related ischemic stroke to be fatal as non-AF stroke.2

67%decrease in AF patient stroke risk with oral anticoagulants.3

AF DETECTION AND TREATMENT MATTERS


Despite an excessive diagnostic workup, about 30% of the stroke patients are still cryptogenic1-6

Most cryptogenic stroke patients receive anti-platelet for secondary prevention7

Long-term monitoring reveals AF in ~30% of cryptogenic stroke patients8

This enables treatment changefrom antiplatelet to oralanticoagulation

1 Sacco RL, et al. Ann Neurol. 1989;25:382-390.2 Petty GW, et al. Stroke. 1999;30:2513-2516. 3 Kolominsky-Rabas PL, et al. Stroke. 2001;32:2735-2740.4 Schulz UG, et al. Stroke. 2003;34:2050-2059.5 Schneider AT, et al. Stroke. 2004;35:1552-1556.

6 Lee BI, et al. Cerebrovasc Dis. 2001;12:145-151.7 Kernan WN, et al. Stroke. 2014;45:2160-2236.8 Sanna T, et al. N Engl J Med. 2014;370:2478-2486.

Ischemic Stroke

20%30%

15%

30%Cryptogenic

Stroke

OtherSmall VesselLarge Vessel

CardioembolicCryptogenic Stroke

5%

WHY TALK ABOUT CRYPTOGENIC STROKE?


DIAGNOSIS &MONITORING STRATEGIES

DEFINITIONS OF CRYPTOGENIC STROKE

1 Adams HP, et al. Stroke. 1993;24:35-41.2 Causative Classification System for Ischemic Stroke (CCS). Available at: https://ccs.mgh.harvard.edu/ccs_intro.php. Accessed April 15, 2015.3 Hart RG, et al. Lancet Neurol. 2014;13:429-438.4 Amarenco P, et al. Cerebrovasc Dis. 2013;36:1-5.

%

CLASSIFICATION SCHEME REQUIRED WORK-UP

TOAST1 Not specified

Causative Classification of Stroke (CCS)2

Brain CT/MR, 12-lead ECG, precordial echocardiogram, extra/intravascular imaging

Embolic strokes of undetermined source3

Brain CT/MR, 12-lead ECG, precordial echocardiogram, extra/intravascular imaging, cardiac monitoring for ≥ 24 hours

ASCO(D) phenotyping4 Does not include a cryptogenic stroke category


CRYPTOGENIC STROKE IS A DIAGNOSIS OF EXCLUSION

Bang OY, et al. Stroke. 2014;45:1186-1194.

%Atherosclerotic

Small arterial occlusion

Cardioembolic

Other causes

Cryptogenic

Arteroembolic*

Aortoembolic

Branch occlusive disease †

Paroxysmal atrial fibrillation

Paradoxical embolism

Cancer-related coagulopathy

Small arterial occlusion

Cardioembolic

Atherosclerotic*

Other causes

Cryptogenic


CONVENTIONAL MONITORING STRATEGIES

1 Kurka N, Bobinger T, Kallmünzer B et al. Reliability and limitations of automated arrhythmia detection in telemetric monitoring after stroke. Stroke 2015; 46: 560 – 563.2 Vasamreddy CR, et al. J Cardiovasc Electrophysiol. 2006;17:134-139

During Stroke Unit or Intensive Care Unit stay

24 hours to 7 days of monitoring Up to 30 days of monitoring

Event-triggered recording available External loop recorder Event-triggered loop recorder

Optional storage of cardiac rhythm data

Saves all cardiac rhythm data Saves events only

High false-positives rate1 62% patient compliance2

BedsideMonitoring


HolterMonitor

EventRecorder

REVEAL LINQ™ WITH TRURHYTHM ™

THE LONG-TERM MONITORING SOLUTION

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

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. 2013.3 Pürerfellner H, et al. Heart Rhythm. 2015;12:1113-1119.

Proven smart detection algorithms that streamline data with TruRhythm™


MR Conditional at 1.5 and 3.0 Tesla

EVIDENCE

CRYSTAL-AF STUDYSTUDY DESIGN AND END POINTS

Randomized, controlled clinical trial with 441 patients

Compared continuous, long-term monitoring with Reveal™ ICM vs. conventional follow-up

Assessment at scheduled and unscheduled visits

ECG monitoring performed at the discretion of the site investigator

15%

30%Cryptogenic

Stroke

Source: Sanna T, et al. N Engl J Med. 2014;370:2478-2486.

End Point

Primary Time to first detection of AF at 6 months of follow-up

Secondary Time to first detection of AF at 12 months Recurrent stroke or TIA Change in use of oral anticoagulant drugs


CRYSTAL-AF STUDYSTUDY POPULATION


447 patients were enrolled

6 were excluded 4 did not meet eligibility criteria 2 withdrew consent

441 underwent randomization

221 were assigned to ICM 208 had ICM inserted 13 did not have ICM inserted

220 were assigned to control 220 received standard of care

12 crossed over to control12 exited the study 3 died 1 was lost to follow-up 5 withdrew 3 were withdrawn by investigator

6 crossed over to ICM13 exited the study 2 died 1 was lost to follow-up 7 withdrew 3 were withdrawn by investigator

221 were included in intention-to-treat analysis 220 were included in intention-to-treat analysis


CRYSTAL-AF STUDYPATIENT INCLUSION CRITERIA

Age ≥ 40 years

Diagnosis of stroke or TIA occurring within previous 90 days

Stroke was classified as cryptogenic after extensive testing:

12-lead ECG

≥ 24 hours of ECG monitoring

TEE

Screening for thrombophilic states (in patients < 55 years of age)

Magnetic resonance angiography, computerized tomography angiography, or catheter angiography of head and neck

Ultrasonography of cervical arteries or transcranial Doppler ultrasonography of intracranial arteries allowed in place of MRA or CTA for patients aged ≥ 55 years


Patients were only categorized as cryptogenic stroke after extensive diagnostic testing.


CRYSTAL-AF STUDYSELECTED BASELINE PATIENT CHARACTERISTICS


Characteristic ICM(n = 221)

Control(n = 220)

P

Age (years) 61.6 ± 11.4 61.4 ± 11.3 0.84

Male 64.3% 62.7% 0.77

White 87.8% 86.8% 0.60

Patent foramen ovale 23.5% 20.9% 0.57

Index event 0.87

Stroke 90.5% 91.4%

TIA 9.5% 8.6%


CRYSTAL-AF STUDY

CONTINUOUS MONITORING WITH REVEAL ICM IS SUPERIOR TO SOC FOR THE DETECTION OF AF IN CRYPTOGENIC STROKE PATIENTS


AF DETECTION RATE


CRYSTAL-AF STUDYLEARNINGS



79%of first AFepisodes wereasymptomatic at12 months

84DAYSis the median timeto AF detection incryptogenic strokepatients

(12 months endpoint)

88%of patients whohad AF would havebeen missed if onlymonitored for30 days*

*Based on Kaplan Meier estimates.

Note: For illustrative purposes only.1 Sanna T, et al. N Engl J Med. 2014;370:2478-2486.

79% of first AF episodes were asymptomatic at 12 months1

SHORT- AND INTERMEDIATE-TERM MONITORING MAY MISS MANY PATIENTS WITH PAROXYSMAL AF

COMPARISON OF SHORT-TERM MONITORING AND ICMSCRYSTAL-AF STUDY


CRYSTAL-AF STUDYCLINICAL IMPACT



CLINICAL IMPACT: MORE APPROPRIATE CARE

Short-term cardiac monitoring is NOT sufficient for AF detection in cryptogenic stroke

Extensive external monitoring only found few patients with AF:- In the control group at 6 months, only 3 patients were found to have AF.- Yet there were 88 conventional ECGs, 20 24-hour Holters, and 1 event recorder used.

Reveal ICM detected over 7 times more patients with AF at the 12-month end point

SUMMARY OF ICM STUDIES IN CRYPTOGENIC STROKE

Study Duration of monitoring(months)

Definition of AF

Time to Diagnosis (days)

AF detection rate (%)

Ritter1 10 >30 seconds 64 17

Etgen2 12 >6 minutes 152 27

Cotter3 8 2 minutes 48 25

SURPRISE4 19 >2 minutes 109 16

Rojo-Martinez5 9 2 minutes 102 33

Ziegler6 24 2 minutes 112 21

Poli7 12 > 2 minutes 105 33

Jorfida8 14.5 > 5 minutes 162 46

CRYSTAL AF9 (ICM arm)

12 36

>30 seconds 84252

1230

Israel10 (ESUS patients) 12 2 minutes 108 24

1Ritter et al, Stroke. 2013, 44:1449-52; 2Etgen et al, Stroke. 44:2007-2009; 3Cotter et al, Neurology. 2013, 80:1546-50; 4Christensen et al, Eur J Neurol. 2014, 21:884-89; 5Rojo-Martinez Rev Neurol 2013; 57 (6): 251-257; 6Ziegler et al. Int J Cardiol, 2017; 244:175-179; 7Poli Eur J Neurol. 2016 Feb; 23(2):375-81; 8 Jorfida J et al, Cardiovasc Med (Hagerstown). 2016 Dec;17(12):863-869 9Sanna T et al, NEJM. 2014;370:2478-2486; 10 Isreal C, et al. Thromb Haemost. 2017 Oct 5;117(10):1962-1969

MULTIPLE STUDIES HAVE ASSESSED THE ABILITY OF ICMS TO DETECT AF IN PATIENTS WITH CRYPTOGENIC STROKE


REAL WORLD VALIDATION OF CRYSTAL AF RESULTSRogers, AAN, 2016

1247 real-world cryptogenic stroke patients monitored by Reveal LINQ™

Cryptogenic stroke diagnosis: physician’s discretion

Follow-up: 12 months

Diagnostic yield at 12 months: 16.3%(n=147)

Median time to detection: 86 days

Analysis supports results of CRYSTAL AF

Continuous monitoring for periods longer 30 days may be warranted in CS patients

Rogers J et al, American Academy of Neurology, http://www.abstractsonline.com/pp8/#!/4046/presentation/8072 2016

72% of AF patients would bemissed if monitoring stoppedat 30 days


http://www.abstractsonline.com/pp8/#!/4046/presentation/8072

26

1247 cryptogenic stroke patients in the DiscoveryLink database

Follow-up: up to 2 years (579 ± 222 days)

AF ≥2 min was detected in 16.3% at 1 year and in 21.5% at 2 years (vs. 4.6% at 30 days)

Median time to AF detection: 112 days (IQR 35-293)

In 74% of patients, the longest episode was >1h

In most patents with multiple AF episodes, durations increased following initial episode

79% of AF patients would have been missed with 30 days of monitoring

Ziegler et al. Int J Cardiol, 2017; 244:175-179

LONG-TERM DETECTION OF ATRIAL FIBRILLATION WITH INSERTABLE CARDIAC MONITORS IN A REAL-WORLD CRYPTOGENIC STROKE POPULATION

Medianduration oflongest AFepisode:4.0 [0.8-12.7]hours


Ziegler et al., 2017

PREDICTORS OF AF OFFER ONLY POOR PREDICTIVE ABILITY CRYSTAL AF sub-analysis: Thijs, Neurology

Parameters tested: Age, sex, race Body Mass Index, Type and severity of index

event CHADS2 score PR-interval Diabetes, hypertension Congestive heart failure Patent foramen ovale Premature atrial contractions

Thijs et al. Predictors for Atrial Fibrillation Detection after Cryptogenic Stroke: Results from CRYSTAL AF. Neurology (in press)

Increasing age and a prolonged PR-interval were independently associated withAF, but the predictive ability of these parameters was only moderate


CONTINUOUS MONITORING IS SUPERIOR TO INTERMITTENTCRYSTAL AF sub-analysis: Choe, Am J Cardiol 2015

Choe et al. A comparison of atrial fibrillation monitoring strategies after cryptogenic stroke (from the CRYSTAL AF trial). Am J Cardiol. 2015;116:889-93.

MONITORING METHOD

24-H

our

48-H

our

7-Day

21-D

ay

30-D

ay

4 Qua

rterly

24-hr

Holt

ers

4 Qua

rterly

48-hr

Holt

ers

4 Qua

rterly

7-da

y Holt

ers

12 M

onthl

y 24-h

r Holt

ers

Sens

itivi

ty (%

)N

egat

ive

Pred

ictiv

e Va

lue

(%)

0

20

40

60

80

100

all p<0.001 vs. Continuous Monitoring

Simulated intermittent monitoring was compared to continuous rhythm monitoring in 168 ICM patients

Short-term Monitoring24-hour 48-hour7-day Holter21-day event recorder30-day event recorders

Periodic MonitoringQuarterly 24-hour HoltersQuarterly 48-hour HoltersQuarterly 7-day HoltersMonthly 24-hour Holters

Sensitivity was low: 1.3-22.8%Negative predictive value: 82.3-85.6%

“Intermittent rhythm monitoring wouldhave failed to identify previously undiagnosedAF in the vast majority of CS patients”


DETECTION OF AF IN ESUS PATIENTS

123 ESUS patients with ICM

Mean follow-up for 12 months

Average time between stroke and implant: 20 days

Interrogation daily using remote monitoring

Results:

AF detected is 23.6%

Average time to detection was 3.6 months

Isreal C, et al. Thromb Haemost. 2017 Oct 5;117(10):1962-1969

Israel C. et al, Thromb Haemost. 2017 Oct

DEFINITION OF ESUS

Imaging showing embolic infarction

Ultrasound of brain-supplying arteries

Routine ECG

72-hour continuous rhythm monitoring on the stroke unit

Additional 24-h – 72 h Holter ECG

Transesophageal echocardiography

Transthoracal echocardiography

Laboratory testing to disclose thrombophilia, M. Fabry, etc.

AF was found in about 1 out of 4 patients usingthe ESUS criteria for selection. The patientshave been monitored remotely for a meanduration of 12 months.


SUMMARY: DAYS TO DETECTION OF AF IN CLINICAL STUDIES OF ICMS

1. Cotter PE, et al. Neurology. 2013;80:1546-1550.2. Etgen T, et al. Stroke. 2013;44:2007-2009.3. Ritter MA, et al. Stroke. 2013;44:1449-1452.4. Rojo-Martinez E, et al. Rev Neurol. 2013;57:251-257.5. Christensen LM, et al. Eur J Neurol. 2014;21:884-889.6. Sanna T, et al. N Engl J Med. 2014;370:2478-2486.7. Ziegler et al. Int J Cardiol, 2017; 244:175-1798. Isreal C, et al. Thromb Haemost. 2017 Oct 5;117(10):1962-1969

48

161

64

102 109

84

112 108

0

50

100

150

200

Cotter(2 min)

Etgen(6 min)

Ritter(2 min)

Rojo-Martinez(2 min)

SURPRISE(2 min)

CRYSTAL AF(2 min)

Real World(2 min)

Israel(2 min)

Day

s fr

om In

sert

ion

N = 51 N = 60N = 22 N = 85N = 101 N = 441

1 2 3 4 5 6

N = 1247

7

N = 123

8


25.5 27.3

16.7

33.7

16.1

30.0

21,5 23.6

0

10

20

30

40

50

Cotter(2 min)

Etgen(6 min)

Ritter(2 min)

Rojo-Martinez(2 min)

SURPRISE(2 min)

CRYSTAL AF*(2 min)

Real-World(2 min)

Israel(2 min)

SUMMARY: AF DETECTION YIELD IN CLINICAL STUDIES OF ICMS

AF

Det

ecti

on Y

ield

(%)

1. Cotter PE, et al. Neurology. 2013;80:1546-1550.2. Etgen T, et al. Stroke. 2013;44:2007-2009.3. Ritter MA, et al. Stroke. 2013;44:1449-1452.4. Rojo-Martinez E, et al. Rev Neurol. 2013;57:251-257.5. Christensen LM, et al. Eur J Neurol. 2014;21:884-889.6. Sanna T, et al. N Engl J Med. 2014;370:2478-2486.7. Ziegler et al. Int J Cardiol, 2017; 244:175-1798. Isreal C, et al. Thromb Haemost. 2017 Oct 5;117(10):1962-1969

N = 51 N = 60N = 22 N = 85N = 101 N = 441

1 2 3 4 5 6

N = 1247

7

N = 123

8


GUIDELINES

2016 ESC AF GUIDELINES

Actual ESC guidelines on the diagnosis and management of AF

European Stroke Organization endorsed these guidelines

Kirchhof P, et al. Eur Heart J. 2016 Aug 27. pii: ehw210.


2016 ESC AF GUIDELINES

RECOMMENDATION CLASS LEVEL

In stroke patients, additional ECG monitoring by long-term non- invasive ECG monitors or implanted loop recorders should be considered to document silent atrial fibrillation.

IIa B

Kirchhof P, et al. Eur Heart J. 2016 Aug 27. pii: ehw210.

ICM RECOMMENDATION FOR CRYPTOGENIC STROKE


Classes of recommendations

Definition Suggested wording to use

Class IIa Weight of evidence/opinion is in favour of usefulness/efficacy.

Should be considered

Level ofevidence B

Data derived from a single randomized clinical trial or large non-randomized studies.

REVEAL LINQ™ SYSTEM

REVEAL LINQ™ SYSTEM ADVANTAGESSIMPLE INSERTION PROCEDURE

Best location: 45 degrees to sternum over 4th intercostal space, 2 cm from left edge of sternum

97%of physiciansfound the insertion tool simple and intuitive.1

1 Reveal LINQ™ Usability Study. Medtronic data on file. 2013.


Requires minimal procedure timeand clinical resources

Reveal LINQ™

NEW simplified insertion and tight pocket for better signal

NEW AF algorithm with increased accuracy

AF

NEW algorithms with Smart filtering Self-learning intelligence

Streamlined episode review for clinic efficiency1,2

TruRhythm™

Detection

PAUSEBRADY AF

TRURHYTHM™ DETECTION INSIDEACCURACY EVOLUTION

Reveal™ XT

AFIndustry’s first AF detection algorithm

2009 2011 20172014

Reveal™ XT

NEW AF algorithm and improved noise discrimination

NEW Pause algorithm with diminishing R-wave analysis

AF

PAUSE

With FullView ™ Software

1 TruRhythm™ Detection Efficiency. Medtronic data on file. 2017.2 TruRhythm™ Detection Algorithms. Medtronic data on file. 2017.


TRURHYTHM™ INTELLIGENT DETECTIONNEW ALGORITHMS

SMART FILTERING SELF-LEARNINGNEW 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


REVEAL LINQ™ ICM SYSTEMPROVEN ARRYTHMIA DETECTION.INFORMED CLINICAL DECISIONS.

Highest published AF detection accuracy on the market, at 99.7%1

As the most clinically-validated ICM, with 50+ detection performance papers, Reveal LINQ™ ICM is the reliable choice for arrhythmia management2

99.7%

50+

Reveal LINQ™ ICM is proven to find AF

1. Sanders P, Pürerfellner H, Pokushalov E, et al. Performance of a New Atrial Fibrillation Detection Algorithm in a Miniaturized ICM: Results from the Reveal LINQ™ Usability Study. Heart Rhythm. July 2016;13(7):1425-1430.

2. Medtronic Reveal AF Publications. Medtronic data on file. 2016.


TRURHYTHM™ PROVEN DETECTION


* Based on Kaplan Meier estimates† Episodes detected are ≥ 2 minutes** Compared with the Reveal LINQ™ ICM without TruRhythm™ Detection

1 Sanna T, et al. N Engl J Med. 2014;370(26):2478-2486.2 TruRhythm™ Detection Algorithms. Medtronic data on file. 2017.3 Edvardsson N, et al. Europace. 2011;13(2):262-269.4 TruRhythm™ Detection Efficiency. Medtronic data on file. 2017.

5 Kirchhof P, et al. Eur Heart J. Published online August 27, 2016. Accessed online August 31, 2016.

6 Task Force for the Diagnosis and Management of Syncope, et al. Eur Heart J. November 2009;30(21):2631-2671.

Cryptogenic stroke

Why Reveal LINQ™ ICM? 88% percent of AF patients would be missed if monitoring stopped at 30 days*1

Why TruRhythm™ Detection? Don’t miss an AF episode† with high sensitivity and streamlined data review2

Syncope

Why Reveal LINQ™ ICM? 78% of patients with recurrent syncope are diagnosed with an ICM3

Why TruRhythm™ Detection? Spend half the time reviewing false detect data, with significant improvement in Brady and Pause detections**2,4

Atrial fibrillation

Why Reveal LINQ™ ICM? Short and intermittent monitoring will likely miss many patients with paroxysmal AF1

Why TruRhythm™ Detection? Manage AF patients over time with more actionable and accurate reports2

The Reveal LINQ™ ICM is guideline-recommended for Cryptogenic Stroke and Syncope5,6

40

CONFIDENCE ACROSS INDICATIONS

CLINICAL RIGOREVIDENCE SUPERIORITY.REAL-WORLD IMPACT.

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

MostStudied ICM

Most Clinically Validated ICM

Only ICM with Premier Clinical Evidence

With an evidence portfolio of 500+ published clinical articles andabstracts1

Across Cryptogenic Stroke, Syncope, and Atrial Fibrillationpatient populations2-4

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. 2016.2 Sanders P, et al. Heart Rhythm. 2016;13:1425-1430.3 Sanna T, et al. N Engl J Med. 2014;370:2478-2486.4 Edvardsson N, et al. Europace. 2011;13:262-269.5 Krahn AD, et al. J Am Coll Cardiol. 2003;42:495-501.


Patient AssistantInsertion Tools LINQ™ Mobile Manager App-based programmer

SOLUTION ENABLERS

CareLink Network & Reports

MyCareLink™

Patient MonitorReveal LINQ™ ICMwith TruRhythm™

Wireless Cellular

FOCUSON™

Monitoring Service

REVEAL LINQ™ ICM SYSTEMAN ADVANCED MONITORING SOLUTION



HOW REMOTE MONITORING WORKSTHE MEDTRONIC CARELINK SYSTEM

Schematic representation of the CareLink™ system for data transfer between ICM and healthcare professional.

43

REVEAL LINQ™ MOBILE MANAGERSIMPLE, FLEXIBLE, CONNECTED

Reveal LINQ™ Mobile Manager is an innovative app-based programming solution for Reveal LINQ™ devices:

A flexible tablet-based system for both iOS and Android operating systems.

Communicates wirelessly via Bluetooth technology built into our Medtronic patient connector.

The simplicity, flexibility and connectivity continue to receive positive reviews from our customers.

NEW REVEAL LINQ™ MOBILE MANAGER EXPERIENCE With feedback from clinicians worldwide, Medtronic continues to enhance the Reveal LINQ™ Mobile Manager system with updates to our app that include upgraded security and enhanced data visibility.


FOCUSON™ SUPERIOR MONITORING AND TRIAGE SERVICE

A service that saves time for healthcare professionals and enables a higher quality of care.

THE CONTINUOUS FOCUSON™ PROCESSThe FOCUSON™ service is built around a highly skilled team that classifies transmitted patient data based on agreed protocol and promptly notifies the physician, allowing efficient and effective patient treatment.

TIMELY, ACTIONABLE INSIGHTS FOCUSON™ notifies hospital Clinical Teams with the insights they need, when they need them, using phone and email communication prioritized by color-coding.

2mMultilingual team of cardiologists and ECG technicians with 2 million ECGs of experience since 19771

Quality of monitoring

66,000ECGs per year1

1 Medtronic and Fysiologic BV data on file


CRYPTOGENIC STROKECARE PATHWAY

ISCHEMIC STROKE WORK-UP

Used with permission from Matthew C. Holtzman, MD. Neurology Michigan P.C. This pathway represents Dr. Holtzman’s clinical practice. Medical judgment should be used to determine if adopting pathway is appropriate.

STROKE

Lacunar infraction:small vessel disease

Embolic appearing stroke with no history of AF: Multiple foci of infarction Cortical watershed

distribution Cerebellar

History of AF?

Standard stroke work-up

Standard stroke work-up

Antiplatelet agent AnticoagulationStandard stroke work-up

MRA or CTA of intracranial vessels Transesophageal Echocardiogram (TEE)

Symptomatic carotid stenosis greater than 50%

Intracranial stenosis

Positive TEEAll testing negative?

CEA or stent Anticoagulant

Cryptogenic Stroke/ TIA

MultifocalMonofocal

Medical management Antiplatelet agents

Angiogram Lumbar puncture Vasculitis work-up


CRYPTOGENIC STROKE PATHWAY

Pathway based on the consensus of the Cryptogenic Stroke Pathway steering committee. February 2016.

Medtronic Disclosure Statement: This pathway is provided for educational purposes and should not be considered the exclusive source for this type of information. It is the responsibility of the practitioner to exercise independent clinical judgment.

Refer to the brief statement for indications, warnings/precautions, and complications for the Reveal LINQ™ ICM.


CONCLUSIONS

Approximately one-third of ischemic strokes are classified as cryptogenic

Up to 30% of cryptogenic stroke patients have undiagnosed AF

The more you look, the more you find Short- to intermediate-term cardiac rhythm monitoring may not be enough

to detect paroxysmal AF in your cryptogenic stroke patients

CRYSTAL-AF demonstrates superiority of continuous, long-term monitoring of cryptogenic stroke patients with an ICM

2016 ESC guidelines recommend monitoring with ICMs in cryptogenic stroke patients

Reveal LINQ™ ICM Up to 3 years of continuous cardiac monitoring with the world’s smallest ICM

Proven AF detection algorithm with industry leading accuracy

Safe for use in MRI setting same day at 1.5 and 3.0 Tesla*

*Reveal LINQ™ ICM has been demonstrated to pose no known hazards in a specified MRI environment with specified conditions of use. Please see the Reveal LINQ™ ICM clinician manual or MRI technical manual for more details.

PATIENT CASE STUDY

Reveal LINQ™ ICM used to discover AF in 22-year-old stroke patientOn his way to a soccer game, 22-year-old Scott suddenly began wobbling. His head started throbbing. What he thought was dehydration turned out to be much worse. The college student had suffered a stroke. Surgeons removed a blood clot in his brain, but a looming question remained: What caused the stroke in this seemingly healthy young man?

Scott’s doctors suspected it was the result of atrial fibrillation (AF). So Scott’s doctors turned to the Reveal LINQ™ ICM, which, within a few months, confirmed he had AF.

The diagnosis not only gave Scott’s doctors the information they needed to prescribe stroke-preventive blood thinners; it gave Scott the peace of mind to live life fully again.

FPO

SCOTT’S STORYCRYPTOGENIC STROKE PATIENT IMPACT


Actual patient photo. This story reflects one person’s experience. Not every person will receive the same results.

51-year-old woman

Episode of unsteady gait and dizziness (< 1 hour)

On admission:

BP 140/86

HR 68 BPM

No neurologic deficits

After urgent MRI, admitted to intensive care unit for further assessment

20%

CASE STUDY


Two areas of infarct were identified in theleft cerebellum

MRA of head and neck and chest x-rayreturned normal results

TTE showed normal LV size and function

Subsequent TEE confirmed these results,also showed that her atrial size was at theupper limits of normal

TEE showed that there was no thrombus and normal velocities in the LAA,a normal aortic arch, and no evidence of a patent foramen ovale

24-hour telemetry monitoring was negative for arrhythmia

20%

CASE STUDY


Patient discharged on clopidogrel 75 mg/day and was followed for an additional 14 days with MCT

No arrhythmias identified during this period

CASE STUDY


Five weeks after her initial stroke presentation, she developed a recurrence of unsteadiness and dizziness

Patient also developed a right-sided headache with nausea and vomiting

Symptoms lasted 2 hours

Patient was admitted to the ICU after an urgent brain MRI

CASE STUDY


CASE STUDY


CASE STUDY

The patient underwent extensive additional evaluation, including a work-up for hypercoagulability, which was negative

She was subsequently implanted with an ICM and discharged on clopidogrel and aspirin

After 2 months of monitoring, episodes of paroxysmal AF lasting 15 to 90 minutes were detected

Episodes were asymptomatic despite mean ventricular rates > 120 BPM

The patient was subsequently prescribed an oral anticoagulant

SUMMARY


BRIEF STATEMENTSee the device manual for detailed information regarding the instructions for use, the implantprocedure, indications, contraindications, warnings, precautions, and potential adverse events. Ifusing an MRI SureScan device, see the MRI SureScan® technical manual before performing anMRI. For further information contact your local Medtronic representative and/or consult the Medtronicwebsite at www.medtronic.com.

Consult instructions for use at this website. Manuals can be viewed using a current version of anymajor 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 productsand 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 nothave authorization for use.

EuropeMedtronic International Trading Sàrl. Route du Molliau 31Case postaleCH-1131 Tolochenazwww.medtronic.euTel: +41 (0)21 802 70 00Fax: +41 (0)21 802 79 00

UC201600838aEE ©2018 Medtronic. All rights reserved. Printed in Europe.

medtronic.eu

Medtronic and the Medtronic logo are trademarks of Medtronic.™*Third party brands are trademarks of their respective owners.All other brands are trademarks of a Medtronic company.

United Kingdom/Ireland Medtronic LimitedBuilding 9Croxley ParkHatters LaneWatfordHerts WD18 8WW www.medtronic.co.ukTel: +44 (0)1923 212213 Fax: +44 (0)1923 241004

this is the new powerpoint template...presentation. agenda epidemiology ... wickramasinghek, et al....

Documents