Implantable Loop Recorders - PowerPoint Presentation

Slide1

Implantable Loop Recorders

JohN. Catanzaro MD, FACC, FESC, FHRSAssociate Medical Director Electrophysiology ProgramAssociate Program Director Clinical Cardiac Electrophysiology ProgramSlide2

Disclosures

Fellowship Support – Medtronic, Abbott, Boston ScientificCenter of Training – Boston ScientificAdvisory Boards – CorMatrixResearch Grants – Boston ScientificSlide3

Long Term Continuous Monitoring

Unexplained Syncope  Palpitations 

Cryptogenic Stroke 

Suspected Atrial Fibrillation 

Atrial Fibrillation Monitoring 

 Slide4

Syncope

Syncope accounts for 3-5% of ED visits and 1-3% of all hospital admissions1,2Cardiac syncope carries a 6-month mortality rate of greater than 10%, and doubles the risk of death1Syncope negatively impacts patient quality of life

3,4

Diagnosing patients with infrequent symptoms using a conventional

Holter

monitor is unlikely, due to low symptom-ECG correlation

Avoid over-testing, yet also avoid under diagnosingSlide5

Flavors of Syncope

Survival Rates with and without Syncope

Higher mortality rates for patients with a cardiac cause for syncope

1. Soteriades

ES, Evans JC, Larson MG, et al. Incidence and prognosis of syncope.

N Engl J Med.

September 19, 2002; 347(12):878-885.Slide6

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 MedicineEndorsed by the Pediatric and Congenital Electrophysiology SocietyWRITING COMMITTEE MEMBERSWin-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*§Slide7

Note:

types

of

clinical data qualify level

of

evidence

•

i.e.

“randomized”/

”non

randomized

”

Source:

Shen WK, et al.. J Am Coll Cardiol. 2017. DOI: 10.1016/j.jacc.2017.03.003.Slide8

Syncope

Source:

Shen

WK,

et al.. J

Am

Coll

Cardiol.

2017. DOI:

10.1016/j.jacc.2017.03.003.Slide9

CHARACTERISTICS IDENTIYING

PATIENTS MOST LIKELY TO

BE

ASSOCIATED

WITH A

CARDIAC

CAUSE

Source: Shen

WK,

et al.. J

Am

Coll Cardiol. 2017. DOI: 10.1016/j.jacc.2017.03.003.

Histoty

of Cardiac Causes of SyncopeOlder age (>60yr)Male SexPresence 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

positionLow number of events (1 or 2)Abnormal cardiac examinationFamily history of inheritable conditions or premature SCD (<50 yr of age)Presence of known congenital heart disease

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

recommendedSlide10

Cryptogenic Stroke

Cerebral

Stroke etiologies

Types of Ischemic Stroke

Atherothrombotic (25-30%)

Stenotic artery feeding area of infarction

Cardioembolic (20%)

A thrombus or other material dislodges from the heart or aortic arch

Other/Uncommon (5-10%)

Cryptogenic (25-40%)

Unknown cause

Artery Occlusion (85%)

Vessel Rupture (15%)Slide11

CRYSTAL AF Study Results

Reveal ICM superior to SoC for finding AF in patients with a cryptogenic stroke

1

The more you look, the more you find

Over

7x more

patients with AF in the ICM at 12-month end point

At 36 months, AF was detected at rate of 30% in the ICM arm compared to 3% in the standard follow-up arm

Short-term monitoring not sufficient for cryptogenic stroke patients

Median time to AF detection over 12 months was 84 days

Clinical Impact: more appropriate care

Patients with AF are prescribed OAC to reduce recurrent stroke risk

At 12 months

, 97%

of patients in ICM arm with AF prescribed OACSlide12

Older age

(>60yr)

Male

Sex

Palpitations or no symptoms prior to loss of consciousness

Occurs

with

exertion

Structural heart

disease

Heart

failure

Cerebrovascular diseaseFamily history of SCDTraumaBleeding evidence

Persistent abnormal vitals/ECG

Positive

troponin

Older age

(>60yr)

Male

Sex

Absence of nausea/vomiting before syncopeVentricular arrhythmias detectedCancerStructural heart diseaseHeart failureCerebrovascular disease

Diabetes

mellitus

High CHADS2

score

Abnormal

ECG

Low GFR (kidney function)Short-term (<30 d) risk factorsLong-term (>30d) risk factors

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

IIbB-NRUse 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

evaluationSlide13

Class

I

Recommendation

ICMs

should

be placed in all patients

with

infrequent

symptomsSlide14

Cryptogenic Stroke

25%-30% of all ischemic strokes are considered cryptogenic, despite intensive work-up1Potential that undiagnosed atrial fibrillation is present in patients with cryptogenic strokeDetection of AF in cryptogenic stroke patients changes treatment

Guidelines state change from antiplatelet to OAC

2

1

Adams

HP Jr,

Stroke

. Jan 1993; 24; 35-41;

2

Camm

et al,

European Heart Journal

. 2012; 33, 2719-2747Slide15

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 usefulIIaB-NRTo

evaluate

selected ambulatory patients

with

syncope

of suspected

arrhythmic

etiology,

the

following external cardiac monitoring approaches can be useful:

Holter monitorTranstelephonic monitorExternal loop recorderPatch recorderMobile cardiac outpatient

telemetry

Cardiac monitoring is necessary

Patient selection

is

based on

frequency

of symptoms,

likelihood

of arrhythmic

causeand patient characteristicsRandomized clinical trials demonstrate the value of ICM monitoring in syncope patientsSource: Shen WK, et al.. J Am Coll Cardiol. 2017. DOI: 10.1016/j.jacc.2017.03.003.Slide16

Monitoring Selection Criteria

Duration

24 – 48

hrs

2-14

days

Up to

1

month

Patient

Selection

Daily,

symptoms

Weeklysymptoms

Monthly

Monthly,

symptoms

symptoms

(some up

to

6

wks)

≤3 yearsRecurrent, infrequent sy

mptoms

Diagnostic choice should be based on frequency

of

symptoms and nature

of

syncope

events.

Source: Shen

WK, et al.. J Am Coll Cardiol. 2017. DOI: 10.1016/j.jacc.2017.03.003.Slide17

Term

Definition/Comments

Syncope

A

symptom

that presents

with

an abrupt, transient, complete loss of

consciousness, associated with

inability

to

maintain

postural

tone, with rapid and spontaneous recovery. The

presumed

mechanism

is cerebral

hypoperfusion.

There should not be clinical

features

of other nonsyncope causes of loss of

consciousness,

such as seizure, antecedent head trauma, or apparent loss of consciousness (i.e., pseudosyncope)Loss of consciousnessA cognitive state in which one lacks awareness of oneself and one’s situation, with an inability to respond to stimuli.

Transient

Loss

of consciousness

Self-limited loss of

consciousness

can be

divided

into

syncope and nonsyncope conditions. Nonsyncope conditions include but are not limited to seizures, hypoglycemia, metabolic conditions, drug or alcohol intoxication, and concussion due to head trauma. The underlying mechanism of syncope is presumed to be cerebral hypoperfusion, whereas nonsyncope conditions are attributed to different mechanisms.

Presyncope (

near-syncop

e)

The symptoms

before

syncope.

These

symptoms

could include

extreme

lightheadedness; visual sensations, such as “tunnel vision” or “graying out”; and variable degrees of altered consciousness without complete loss of consciousness. Presyncope could progress to syncope, or it could abort without syncope

Unexplained syncope (syncope of undetermined etiology)Syncope for which a cause is undetermined after an initial evaluation that is deemed appropriate by the experienced healthcare

provider.

The

initial

evaluation

includes

but

is not limited to a thorough

history,

physical examination,

and

ECG.

Cardiac

(car

d

i

o

v

asc

ul

a

r

)

Syncope

Syncope

caused

by

bradycardia,

tachycardia,

or

hypotension

due

to

low

cardiac

index,

blood flow

obstruction, vasodilatation,

or acute

vascular

dissectionSlide18

Term

Definition/Comments

Syncope

A

symptom

that presents

with

an abrupt, transient, complete loss of

consciousness, associated with

inability

to

maintain

postural

tone, with rapid and spontaneous recovery. The presumed

mechanism

is cerebral

hypoperfusion.

There should not be clinical

features

of other nonsyncope causes of loss of

consciousness,

such as seizure, antecedent head trauma, or apparent loss of

consciousness

(i.e., pseudosyncope)Loss of consciousnessA cognitive state in which one lacks awareness of oneself and one’s situation, with an inability to respond to stimuli.

Transient

Loss

of consciousness

Self-limited loss of

consciousness

can be

divided

into

syncope and nonsyncope conditions. Nonsyncope conditions include but are not limited to seizures, hypoglycemia, metabolic conditions, drug or alcohol intoxication, and concussion due to head trauma. The underlying mechanism of syncope is presumed to be cerebral hypoperfusion, whereas nonsyncope conditions are attributed to different mechanisms.

Presyncope (n

ear-syncope)

The symptoms

before

syncope.

These

symptoms

could include

extreme

lightheadedness; visual sensations, such as “tunnel vision” or “graying out”; and variable degrees of altered consciousness without complete loss of consciousness. Presyncope could progress to syncope, or it could abort without syncopeUnexplained syncope (syncope

of undetermined etiology)Syncope for which a cause is undetermined after an initial evaluation that is deemed appropriate by the experienced healthcare provider.

The

initial

evaluation

includes

but

is not limited to a thorough

history,

physical examination,

and

ECG.

Cardiac

(car

d

i

o

v

asc

ul

a

r

)

Syncope

Syncope caused by bradycardia, tachycardia, or hypotension due to low cardiac index, blood flow obstruction, vasodilatation, or acute vascular dissection

Source: Shen

WK,

et al.. J

Am

Coll Cardiol. 2017. DOI: 10.1016/j.jacc.2017.03.003.Slide19

AF Monitoring

AF may be intermittentAF may be asymptomaticAF duration may be importantIntermittent asymptomatic AF of “short” duration can lead to….

Stroke

Heart failureSlide20

Time from Device Implant (months)

0

3 mo.

6 mo.

9 mo.

12 mo.

Freedom from AT/AF

0.5

0.6

0.7

0.8

0.9

1.0

Number at Risk:

163

127

111

106

67

89%

of NDAF patients identified beyond

1 day

78%

of NDAF patients identified beyond

7 days

60%

of NDAF patients identified

beyond 30 days

Newly Detected AF (“NDAF”) in Patients with Thromboembolic Events

163 patients with previous ischemic stroke/TIA, no known AF, were continuous monitored via pacemaker

or ICD

NDAF

>

5 minute duration were found in 28% patients

73% of patients had newly detected AT/AF on <10%

of follow-up days

Ziegler P. et al.

Stroke

. 2010;41

The Value of Long Term Continuous Monitoring – Detect intermittent AF

TRENDS Study Subgroup AnalysisSlide21

Landmark CRYSTAL AF :

CRYptogenic STroke And underLying Atrial Fibrillation

Study Overview

441 Patients had Cryptogenic stroke/TIA

Randomized to

SoC

or ICM

AF defined as ≥ 30 seconds

Primary endpoint

AF detection at 6 months

Secondary endpoints

AF detection at 12 months

AF duration

Symptom correlation

Physician actionsSlide22

CRYSTAL AF:

ICM Rate of detection 30% at 3 years

8.8x more than standard follow-up arm

Sanna T, Diener HC, Passman RS, et al. Cryptogenic Stroke and Underlying Atrial Fibrillation (CRYSTAL AF).

N Engl J Med.

2014; 370(26):2478-2486.Slide23

A Revolutionary System

The Complete Monitoring Solution

Mobile Alerts

Streamlined Reports

Improved CareLink

®

User Interface

Patient Assistant

MyCareLink™ Patient Monitor

Simplified Insertion Procedure

Reveal LINQ™ ICM

Wireless

Cellular

All patient and clinical data are fictitious and for demonstration purposes onlySlide24

LocationSlide25

*Compared to Reveal XT ICM

87% Smaller*

Linear dimensions rounded to the nearest mm

Volume rounded to the nearest tenth of a ccSlide26

Proven AF algorithm accurat

ely detects AF in 99.1% of patients*

5

Simplified procedure and redesigned titanium nitride electrode coating support high-fidelity signals

Edvardsson N, Frykman V, van Mechelin R, et al. Use of an implantable loop recorder to increase the diagnostic yield in unexplained syncope: results from the PICTURE registry.

Europace

. February 2011;13(2):262-269.

Krahn AD, Klein GJ, Yee R, Norris C. Final results from a pilot study with an implantable loop recorder to determine the etiology of syncope in patients with negative noninvasive and invasive testing.

Am J Cardiol.

July 1, 1998;82(1):117-119.

Krahn AD, Klein GJ, Yee R, Takle-Newhouse T, Norris C. Use of an extended monitoring strategy in patients with problematic syncope. Reveal Investigators.

Circulation

. January 26, 1999;99(3):406-410.

Krahn AD, Klein GJ, Yee R, Hoch JS, Skanes AC. Cost implications of testing strategy in patients with syncope: randomized assessment of syncope trial. J Am Coll Cardiol. August 6, 2003;42(3):495-501.Pürerfellner H, Pokushalov E, Sarkar S, et al. P-wave evidence as a method for improving algorithm to detect atrial fibrillation in insertable cardiac monitors. Heart Rhythm. Published online June 6, 2014. *In patients with known AFSlide27

Patient Assistant

It’s recommended for the patient to carry the Patient Assistant at all times.Slide28

Comprehensive

Get the full picture with diagnostic trends on simplified reports

Customizable

Optional CareAlert

®

Notifications

with auto-generated reports

Easy-to-Use, Clinically Actionable Reports

1

The information you need when you need it

:

95%

Of physicians found the Reveal LINQ reports easy to use and clinically actionable

.1

1. Reveal LINQ Usability Study. Data on file. Medtronic, Inc. 2013.Slide29

Event Report

Enhanced Notification1-page notification of new events

30-second summary of 1 episode

Counters and observations summarySlide30

Summary Report

31-Day Overview2-page summary of

last 30 days

Current ECG plus trends, counters, observation summary

Cardiac Compass, Rate Histograms, Longest AFSlide31

Full Report

All the DataDetails since last Full Report

Current ECG, Counters, Observations

Cardiac Compass, Histograms, Longest AF

Holter View for Symptom Episodes Cuts Report Length in HalfSlide32

Provides an overview of all atrial arrhythmias detected, including:

% of time in AT/AFAverage time in AT/AFper dayNumber of episodes

at a given duration

AT/AF Summary ReportSlide33

Provides an overview of

key trends, including:AT/AF burdenV rate during AT/AFAverage V rate

Patient activity

Heart rate variability

Histograms

Longest AF

30-day, 90-day and

14-month views

Cardiac Compass