ROLE OF THE ILR IN HIGH RISK PATIENTS ANDARRHYTHMIC STRATIFICATION
Maggi R.Centro aritmologico e Syncope Unit, Lavagna
Bolzano, 14 novembre 2014
Europace (2009) 11, 671–687www.escardio.org / communities / EHRA / Pubblications / Scientific Document
RelatoreNote di presentazioneThe position paper of the EHRA classifies the indication for the use of diagnostic implantable and external loop recorders in 2 categories:Established indications, namely……………….; and non established indications. In this session is included the use of ILR in risk stratification , which is the topic of my presentation
http://www.escardio.org/
ILR: established indications
• Syncope (T‐LOC):‐ diagnosis‐ ILR‐guided therapy
• Undocumented palpitations
RelatoreNote di presentazioneThe role of ILR is clearly established in syncope and undocumented palpitations
Recommendations: Indications for ILR in patients with syncope
Clinical situation Class Level• In an early phase of evaluation of patients with recurrent syncope of uncertain origin who have:– absence of high‐risk criteria that require immediate hospitalization or intensive evaluation, and– a likely recurrence within battery longevity of the device
I B
• In high‐risk patients in whom a comprehensive evaluation did not demonstrate a cause of syncope or lead to specific treatment
I B
• ILR may be indicated to assess the contribution of bradycardiabefore embarking on cardiac pacing in patients with suspected or certain neurally mediated syncope presenting with frequent or traumatic syncopal episodes
IIa B
• ILR may be indicated in patients with T‐LOC of uncertain syncopal origin in order to definitely exclude an arrhythmic mechanism
IIb B
EHRA Position Paper & ESC Guidelines on Management of Syncope 2009
RelatoreNote di presentazioneInfact, the EHRA and ESC guidelines recommend the use of ILR in an early phase …………..The use of ILR in high risk patients is considered as a class I indication but only in patients in whom a complete evaluation
ESC Guidelines on Management of Syncope Version 2009
RelatoreNote di presentazioneSo the first step is to identify the patient with syncope at high risk of major event who are, at least initially, to excluded in the prolonged monitoring.These patients require immediate in hospital intensive evaluation in order to make risk stratification and immediate therapy if possible.ILR is not indicated when there is a clear indication for ICD….
Laboratory investigations
Cardiac cause likely or suspected
yes no
Cardiac evaluation-Echocardiogram-ECG monitoring-Exercise test-EP study-ILR
NM evaluation-Carotid sinus massage-Tilt testing -ATP test-ILR
ESC Guidelines on Management of Syncope – Update 2009
RelatoreNote di presentazioneBefore considering an ILR in a patients with a cardiac cause likely or suspected, cardiac evaluation has to be performed.For example patients with syncope and left bundle block should be evaluated with echo, ecg monitoring and EP study for Av conductionA patient with syncope and NSVT needs echo, EPS for VT induction with the aim to exclude VT as a cause of syncope
Take home message (I)
• Exclude high‐risk patients from ILR strategy
Implantable Loop Recorder: Diagnosis of Unexplained Syncope
Implantable Loop Recorder: Diagnosis of Unexplained Syncope
ILR: non‐established indications
• Risk stratification:‐ previous myocardial infarction‐ inherited diseases
RelatoreNote di presentazioneThe use of ILR as a non established indication can be considered for risk stratification in pts with previous Ami or inherited disease.
CARISMA ‐ Results
• Incidence and prognostic significance of arrhythmias after AMI with EF ≤40% documented by ILR during a mean follow‐up of 1.9 years:
– 137pts (46%) documented one or more arrhythmia– 86% of these events were reported as asymptomatic
Bloch Thomsen P. et Al. Circulation. 2010;121:1258‐1264
RelatoreNote di presentazioneCARISMA trial was designed to study the incidence and prognostic significance of arrhythmias documented by an implantable cardiac monitor among patients with acute myocardial infarction and reduced left ventricular ejection fraction 297 patients (21%) received an implantable cardiac monitor-Clinically significant bradyarrhythmias and tachyarrhythmias were documented in a substantial proportion of patients, most of them asymptomatic.
Bradyarrhythmia1.0
0.7
0.8
0.9
0.0
0 200 400 600 800Time (days)
Eve
nts
Free
1.0
0.7
0.8
0.9
0.0
0 200 400 600 800Time (days)
Eve
nts
Free
S. ArrestS. BradyAV block
Sinus Arrest n=16 (5%)
Sinus Brady n=20 (7%)
AV Block n=29 (10%)
Bloch Thomsen P. et Al. Circulation. 2010;121:1258‐1264
RelatoreNote di presentazioneThe ILR documented a 10% incidence of high-degree atrioventricular block (30 bpm lasting 8 seconds), a 7% incidence of sinus bradycardia (30 bpm lasting 8 seconds), a 5% incidence of sinus arrest (5 seconds)
1.0
0.5
0.6
0.7
0.8
0.9
0.0
0 200 400 600 800Time (days)
Eve
nts
Free
NSVT
VTsustVF
AFib
Tachyarrhythmia
Ventricular Fib.n=8 3% VT Sust. n=9 3%VT Non-sust. n=39 13%Atrial Fib n=95 32%
Bloch Thomsen P. et Al. Circulation. 2010;121:1258‐1264
RelatoreNote di presentazioneThe ILR documented a 28% incidence of new-onset atrial fibrillation with fast ventricular response (125 bpm), a 13% incidence ofnonsustained ventricular tachycardia (16 beats), 3% incidence of sustained ventricular tachycardia, and a 3% incidence of ventricular fibrillation.
Prognostics of Cardiac Death by ILR • Arrhythmias detected by the ILR were highly prognostic for cardiac death….
Arrhythmia Hazard ratio P-value
AV block
Risk stratification guided by ILR observations: post‐MI
Take home message (II)
• The clinical usefulness of ILR to guide medical and device therapy in patients surviving myocardial infarction has not been demonstrated
• ILRs are useful tools for clinical research and epidemiology of cardiac arrhythmias
RelatoreNote di presentazioneHowever, the study was observational, and whether the use of implantable cardiac monitors in this population could improve clinical outcome should be tested in larger randomized trials.
ILR: non‐established indications
• Risk stratification:‐ previous myocardial infarction‐ inherited diseases
RelatoreNote di presentazioneAnother non established indications for the ILR are the inherited disease. At present, there is not evidence for the use of ECG monitoring in these patients. The use is limited to small series of patients or case reports. In patients survived to suddend death an ICD is indicated.
ILR in inherited diseases
Background
Conventional investigations (Ecg, Echo, EP study) have low capacity to predict the risk of suddendeath in Brugada Syndrome/HCM/ARVD/Long QT syndrome/Early repolarization syndrome
Can ILR monitoring be considered in patients at low risk ?
ILR‐ strategy imply to wait a spontaneous episode
Recommendations: Indications for ICD in patients with unexplained syncope and a high risk of SCDClinical situation Class Level Comments
In hypertrophic cardiomyopathy ICDtherapy should be considered in patients at high risk
IIa C In non high risk, consider ILR
In right ventricular cardiomyopathy ICD therapy should be considered in patients at high risk
IIa C In non high risk, consider ILR
In Brugada syndrome ICD therapy should be considered in patients with spontaneous type I ECG
IIa B In the absence of type I pattern, consider ILR
In long QT syndrome ICD therapy,…., should be considered in patients at high risk
IIa B In non high risk, consider ILR
ESC Guidelines on Management of Syncope - Version 2009
Implantable Loop Recorder: Diagnosis of Unexplained Syncope
308 Brugada pts, no CA
14 events (4.5%): -1 resuscitated CA-13 ICD shocks
Follow-up: 34 months (5-73)
Predictor of events:• Spontaneous type 1 + Syncope (HR=4.2)• QRS fragmentation (HR=4.9)
Priori S et al.
JACC 2012; 59: 37–45
RelatoreNote di presentazioneThe main challeng is how to identify patient with high or intermediate risk. Symptoms and diagnostic tests are sometimes not able to identify pts at risk.If we consider Brugada Syndrome, the prelude study showed that in pts without cardiac arrest, the incidence of events in very low and is difficult to find predictors of events. Syncope seems to be a predictor of events in patients with spontaneous type 1.
10-year mortality/appropriate shocks in Brugada patternSacker at al. Circulation. 2013;128:1739-1747
Complications:- Inappropriate shocks: 37%- Lead failure: 29%
48%
19%
12%
RelatoreNote di presentazioneBut if we consider the results of the biggest follow up in Brugada pts, after 10 years syncope patients have a survival very similar asymptomatic patients.
Priori S et al.
JACC 2012; 59: 37–45
Survival according to VTs/VF inducibility
Self-terminated ventricular fibrillation recorded by an ICD in a Brugada syndrome patient leading to lightheadedness
Sacker et al. Circulation 2013; 28:1739-1747
RelatoreNote di presentazioneAnother point to consider is that the trials usually use appropriate ICD discharges as a surrogate for sudden death but this could not be true.In this case, recorded by an ICD but recordable even with an ILR, is shown a self terminating VF showing that VF is not equivalent to sudden death
Case study A 48 year old patient with palpitations, recurrent syncopes and Brugada ECG pattern
who was advised to implant an ICD
Palpitation Syncope
ILR documentations
From 2010 to 2013: 65 documented episodes of palpitations and 4 documented syncopes
RelatoreNote di presentazioneILR can be used when symptoms are not suggestive for arrhythmic origin. This is a case we evaluated in our department.
ILR and Brugada204 Brugada pts
11 received ILR
8 had symptomatic events
• 2 AV block • 2 sinus bradycardia• 4 no rhythm variations
• 5 syncope• 3 syncope + palpitation• 1 suspected epilepsy• 2 asymptomatic high risk
Mean FU: 33 months
Conclusion: ILR should be considered in pts with atypical symptoms and spontaneous or transient Type 1 ECG pattern
Kubala M, et al. Europace 2011;14:898‐902
RelatoreNote di presentazioneThe experience with ILR in BS in very low. This is the biggest study, aimed to investigate the effectiveness of ILR as a diagnostic tool in BS patients suspected of low or moderate risk of SCD.
Risk stratification guided by ILR observations: Inherited diseases
Take home message (III) • ILRs have a potential role in identifying the correlation between symptoms and ventricular arrhythmias. • The clinical usefulness of ILR to guide ICD therapy has yet to be demonstrated
Kubala M, et al. Europace 2011;14:898‐902
11 patients with Type 1 ECG pattern and atypical symptoms
Follow‐up 33 months
8 recurrence of symptoms
no ventricular arrhythmia
Conclusion: ILR should be considered in pts with atypical symptoms ans spontaneous or transient Type 1 ECG pattern
RelatoreNote di presentazioneRetrospective study – ILR in BS patients suspected of low or moderate risk of SCD
ECG monitoring and syncope
• In‐hospital monitoring• Holter Monitoring • Event recorder• External loop recorder• Remote (at home) telemetry• Implantable loop recorder
Same
positivity
Criteria
RelatoreNote di presentazioneRegardless to the type of monitoring, the positivity criteria of ECG monitoring are the same:
• Correlation between syncope and an ECG abnormality (brady‐ or tachyarrhythmia)
• (In the absence of such a correlation):‐ ventricular pause >3 sec during waking state‐ periods of Mobitz II 2nd or 3rd degree AV block
during waking state‐ rapid paroxysmal atrial/ventricular tachycardia• Correlation between syncope and sinus rhythm
excludes arrhythmic syncope
Positivity criteria
ECG monitoring and syncope
RelatoreNote di presentazioneECG monitoring is diagnostic in case of correla
ECG monitoring and syncope
Diagnosticpower
In-hospital monitoring 1-7
Holter Monitoring 1-7
External loop recorder 30
Implantable loop recorder 500
RelatoreNote di presentazioneThe duration (and technology) of monitoring should be selected according the risk and the predicted recurrence rate of syncope
RelatoreNote di presentazioneProvided that we exclude patients at high risk of events, when we decide to implant a ILR we have to consider that ….
0 6 12 18 24 30 36 42 48
100
80
60
40
20
0
MonthsNumber at risk
157 108 84 68 45 30 15 9 4
43%
30%
80%
52%
Cum
ulat
ive
inci
denc
e %
Diagnostic yield of very prolonged ILR observationLavagna Arrhyhmologic Centre
Furukawa T. et al. J Cardiovasc Electrophysiol 2012; 23: 67-71
RelatoreNote di presentazioneThe aim of this study was to evaluate the diagnostic value of ILR during very prolongedobservation. The estimated cumulative diagnostic rates were 30%, 43%, 52%, and 80% at 1, 2, 3, and 4 years, respectively; 26% of diagnoses were made after 18 months. 26% of diagnoses were made after 18 months. The diagnostic yield was independent of structural heart disease, bundle branch block, number of syncopes, age, and gender.
Take home message (II)
• Be prepared to wait even for a long time before obtaining a diagnosis
•Include only patients with a high probability of recurrence of arrhythmic syncope in a reasonable time period
Continuous ECG monitoringDiagnosis of Unexplained Syncope
RelatoreNote di presentazione(The diagnostic yield of ILR is a linear function of the length of the observation time). Prolonging observation up to 4 years increased the diagnostic value of ILR in syncopal patients and was safe. A quarter of patients diagnosed needed more than 18 months of follow-up. As consequence, when a strategy of prolonging monitoring is chosen, monitoring should be maintained even for several years until diagnosis is established.
ISSUE
SYNCOPEAdverse Events
Sudden death 2 (0.3%)Non-cardiac death 5 (0.8%)TIA 5 (0.8%)Myocardial infarction 1 (0.2%)Secondary severe trauma 8 (1.4%)ILR explants for pocket infection 8 (1.4%)
Pooled ISSUE 1 and ISSUE 2 results(total 590 patients)
No syncope-related death
Diagnostic yield of very prolonged ILR observationArrhyhmologic Centre ‐ Lavagna 2001‐2010
Non-sudden cardiovascular death 3 (1.9%)Ventricular tachycardia 1 (0.6%)Undocumented syncope recurrence (technical problem) 8 (5.1%)
ILR explants for pocket infection 2 (1.3%)
Adverse Events
No syncope-related death
Furukawa T, et al. J Cardiovasc Electrophysiol 2012; 23: 67-71
RelatoreNote di presentazioneDuring a prolonged observation period, 3 patients (1.9%) died and none suffered arrhythmic death.
Take home message (III)
• ILR strategy is safe provided that high‐risk patients are excluded
Implantable Loop Recorder: Diagnosis of Unexplained Syncope
Bloch Thomsen P. et Al. Circulation. 2010;121:1258‐1264
ILR: non‐established indications
• Risk stratification:‐ previous myocardial infarction‐ inherited diseases
Brugada Syndrome
SHD exposes patients to increased risk of sudden deathDoes syncope give an additive
risk or not ?
Priori S et al.
JACC 2012; 59: 37–45
220
Cardiac Syncope Asymptomarrest18 (8%) 114 (52%)88 (40%)
Sacher F et al. Circulation 2006;114: 2317-2324
Risk stratification: Brugada SyndromeA multicenter Study
Long-term follow-up of prophylactic ICD in Brugada syndromeSarkozy A, et al. Eur Heart J 2007: 28, 334–344
Brugada Syndrome 47
Syncope No syncope
26 (55%) 21 (45%)
Follow-up (47 months): ICD discharge
3 (12%) 4 (19%)
Sarkozy A, et al. Eur Heart J 2007: 28, 334–344
Brugada syndrome
1217
Cardiac arrest Syncope Asymptomatic
222 720275
Follow-up (34 mos): ventricular arrhythmias
Odds ratio P valueCardiac arrest vs Asymptomatic 14.4 0.001Cardiac arrest vs Syncope 3.1 0.003Syncope vs Asymptomatic 4.7 0.002
Paul M. et al. Eur Heart J 2007; 28: 2126‐33
Risk stratification: Brugada SyndromeA metanalysis of worldwide data published before 2006
European Heart Journal 2011; 32, 169–176
Conclusions
(1) In subjects with the Brugada type 1 ECG, no single clinical risk factor, nor EPS alone, is able to identify subjects at highest risk;
(2) a multiparametric approach (including syncope, family history of SD, and positive EPS) helps to identify populations at highest risk;
(3) subjects at highest risk are those with a spontaneous type 1 ECG and at least two risk factors;
(4) the remainder are at low risk.
Type 1 ECG and…
ILR and Brugada204 Brugada pts
11 received ILR
8 had symptomatic events
• 2 AV block • 2 sinus bradycardia• 4 no rhythm variations
• 5 syncope• 3 syncope + palpitation• 1 suspected epilepsy• 2 asymptomatic high risk
Mean FU: 33 months
Conclusion: ILR should be considered in pts with atypical symptoms ans spontaneous or transient Type 1 ECG pattern
Kubala M, et al. Europace 2011;14:898‐902
Case study A 48 year old patient with palpitations, recurrent syncopes and Brugada ECG pattern
who was advised to implant an ICD
Palpitation Syncope
ILR documentations
From 2010 to 2013: 65 documented episodes of palpitations and 4 documented syncopes
JACC 2007; 49: 329–37
Syncope, CA, SD
CA, SD
Number of cardiac events before age 18 years
Recommendations: Indications for ICD in patients with unexplained syncope and a high risk of SCDClinical situation Class Level Comments
In hypertrophic cardiomyopathy ICDtherapy should be considered in patients at high risk
IIa C In non high risk, consider ILR
In right ventricular cardiomyopathy ICD therapy should be considered in patients at high risk
IIa C In non high risk, consider ILR
In Brugada syndrome ICD therapy should be considered in patients with spontaneous type I ECG
IIa B In the absence of type I pattern, consider ILR
In long QT syndrome ICD therapy,…., should be considered in patients at high risk
IIa B In non high risk, consider ILR
ESC Guidelines on Management of Syncope - Version 2009
ILR: non‐established indications
• Risk stratification:‐ previous myocardial infarction‐ inherited diseases
• Atrial fibrillation: ILR‐guided therapy
Symptom‐AF correlation: drug study• Suppression Of Paroxysmal Atrial Tachyarrhythmias (SOPAT) study: 1,033 pts.
recorded Transtelephonic ECG (1 min./day, symptoms)• 54% of AF‐ECGs were asymptomatic• AF was only diagnosed in 37% of the symptom‐triggered ECGs
M. Patten. JCE 2006: 17; 1216-1220
Symptomatic events
Symptom‐AF correlation: cardioversion
• 356 persistent AF pts. one week after successful cardioversion• Only 28% of pts. in AF felt they were in AF
ANergardh. Heart 2006; 92: 1244-1247
• 254 pts. with a DDD pacemaker: correlation between symptoms and EGMs• 79% of pts. with AT on EGM were free of symptoms• 60% of pts. without AT on EGM had symptoms
C. Israel. PACE 2006; 29: 582-588
Symptom‐AF correlation: pacemaker diagnostics
AT documentation in 15% (ECG) and 54% (EGM)
RelatoreNote di presentazione254 pts. with a DDD pacemaker received 24-h Holter monitoring at 6 weeks and ECG recording at 6, 26 and 52 weeks post-implant79% of pts. with EGM documented AT were free of symptoms during at least one follow-up period60% of pts. without EGM documented AT had symptoms at at least one follow-up visit
Hindricks et al. Circulation 2005; 112: 307-313
Episodes of AFduring 7-day-ECG
% asymptomatic episodes
Prior post 3 6 12mos abl abl
Prior post 3 6 12mos abl abl
Symptom‐AF correlation: PV ablation
Arya A, et al. PACE 2007; 30: 458-62
Symptom‐AF correlation: 7‐day Holter
Probability of AF detection after RF ablation (estimated)
Arya A, et al. PACE 2007; 30: 458-62
Studies on AF monitoring by ILRs
• Montenero (JICE 2004) & Schwartzman (JCE 2006): patient-activated only; misdetections and artifacts• XPECT study (on-going): will evaluate the reliability of Reveal XT to detect properly AF• CRYSTAL-AF study: will determine the incidence of AF detected by the ILR in pts with cryptogenic stroke
AF therapy guided by ILR observations
Conclusion• The clinical usefulness of ILR to guide medical and ablation therapies in patients with AF has yet to be demonstrated
• ILRs are useful tools for clinical research and epidemiology of AF
RelatoreNote di presentazioneIl monitoraggio elettrocardiografico è uno strumento diagnostico che viene utilizzato con lo scopo di confermare o escludere bradiaritmie o tachiaritmie intermittenti come causa di sincope.Attualmente sono disponibili diversi sistemi di monitoraggio: ………………………..In generale si può dire che il monitoraggio ECG è indicato quando vi è una elevata probabilità pre-test di identificare una aritmia responsabile della sincope.
RelatoreNote di presentazioneIl monitoraggio elettrocardiografico è uno strumento diagnostico che viene utilizzato con lo scopo di confermare o escludere bradiaritmie o tachiaritmie intermittenti come causa di sincope.Attualmente sono disponibili diversi sistemi di monitoraggio: ………………………..In generale si può dire che il monitoraggio ECG è indicato quando vi è una elevata probabilità pre-test di identificare una aritmia responsabile della sincope.
RelatoreNote di presentazioneIl monitoraggio elettrocardiografico è uno strumento diagnostico che viene utilizzato con lo scopo di confermare o escludere bradiaritmie o tachiaritmie intermittenti come causa di sincope.Attualmente sono disponibili diversi sistemi di monitoraggio: ………………………..In generale si può dire che il monitoraggio ECG è indicato quando vi è una elevata probabilità pre-test di identificare una aritmia responsabile della sincope.
Indications of Implantable Loop Recorder other than syncope:
EHRA Position Paper 2009
Class II, BILR may be indicated in patients with T‐LOC of uncertain syncopal origin in order to definitely exclude an arrhythmic mechanism (Level of evidence C)
No recommendation
ESC guidelines 2009
RelatoreNote di presentazioneConsequently, guideline recommendations are also scarce. In the 2009 EHRA position paper of the European Heart Rhythm Association (11), the indication for ILR for the differential diagnosis between syncopal and non-syncopal T-LOC is a class IIb recommendation.
• recurrent palpitations• atrial fibrillation• stroke• risk stratification in arrhythmogenic disease• vasospastic angina
ILR: non conventional indications
RelatoreNote di presentazioneThe aim of this study was to evaluate the diagnostic value of ILR in order to definitely confirm/exclude an arrhythmic mechanism, thus helping in distinguishing between syncope and epilepsy and syncope and fall.
ILR in Recurrent Palpitation
Giada F et al. J Am Coll Cardiol 2007;49:1951‐6
In subject without severe heart disease and with infrequent palpitations, ILR isa safe and cost‐effective diagnostic approach than conventional strategy
EHRA Position Paper, europace 2009
RelatoreNote di presentazioneKey points for use of ILR and ELR:† ELRs are much more useful for palpitations than for syncope evaluation† ILRs consequently are less frequently indicated† Event records may be useful only when symptoms last enough to allow the patient to activate the recorder† The diagnostic value of loop recorders is higher than Holter.
ILR in Vasospastic angina
Nakai T et al. Europace, 28 Sept 2012
A 66 years old woman with unexplained syncope .Chest disconfort during nighttime: ST elevation and AV block.Diffuse coronary spasm with intracoronary acetylcholine.Calcium anthagonist therapy and pacemaker implantation.
Case study (ICD implantation)A 65 year old patient with angina, no palpitation or syncopes.
Torsaide de Point during effort test. No ST variations.External loop recorder documented ST-elevation
No epicardial coronary stenosis. Coronary spasm with nitroglicerine test.
Baseline ECG TdP during stress-test
ELP baseline ECG ELP ST elevation
ILR in Arrhythmogenic Disease(risk stratification)
Stollberger C et al. Inter Jour Cardiology 163(2013); 146‐148
Case studyA 42 year old female with recurrent syncopes and LVHT with 35-40% EF
AVNRT recording with ILR >> slow pathway catheter ablation
Stollberger C et al. Inter Jour Cardiology 163(2013); 146‐148
Case studyA 6 year old female with recurrent exercise‐induced syncopes.
Negative cardiac investigation, including EP study .Bidirectional ventricular tachycardia documented with ILR
Beta‐blockers ineffective. ICD implatation
Baseline ECG ILR syncope documentation
Philippe M. et al. Europace, Aug 2012
A 14‐years‐old boy with 4 syncopes post‐exertion with seizures and cyanosis in the latter one.Early repolarizatione ECG in inferior leads. Negative cardiac investigations.
Head‐up tilt test induced a typical VVS.After another syncope after‐exertion with seizure, epilepsy was diagnosed and therapy started.
After ILR implantation, an asymptomatic VF during exertion was documented. An ICD was implanted
Baseline ECG
Kenny D, et al. Europace 2009;11: 303‐307
22 patients with congenital heart disease and recurrent syncope or palpitations
Follow‐up 19 months
RelatoreNote di presentazioneRetrospective study – ILR in BS patients suspected of low or moderate risk of SCD
ILR in atrial fibrillation detection after TIA or Stroke
Rational
AF is associated with a 5‐fold risk for stroke and TIAOne third of stroke and TIA are cryptogenicOccult paroxysmal AF has been suggested as a possible cause
Anticoagulation therapy after detection of AF provide additional 40% risk reduction of stroke as compared to antiplatelet therapy alone
ILR in cryptogenic stroke
How to detect occult paroxysmal AF in cryptogenic stroke?
Standard 12‐lead ECGECG monitoring during inpatient stayHolter monitoringEvent recordersExternal loop recorders Mobile telemetry devices
Yield ranges from 1‐5%
Liao J et al. Stroke 2007; 38: 2935‐40
Yield ranges ???
Implantable loop recorders(extension of ECG monitoring for up to 3 years)
RelatoreNote di presentazioneExtension of the ECG monitoring time could lead to an increased AF detection rate in this patient population
ILR in cryptogenic stroke
Liao J et al. Stroke 2007; 38: 2935‐40
RelatoreNote di presentazioneExtension of the ECG monitoring time could lead to an increased AF detection rate in this patient population
ILR in cryptogenic stroke
Dion F et al. J Interv Card Electrophysiol 2010; 28: 101‐07
RelatoreNote di presentazioneExtension of the ECG monitoring time could lead to an increased AF detection rate in this patient population
Paul E. et al. Neurology ; 2013: 80; 1546‐50
ILR was implanted in 51 patients with unexplained stroke.
AF was detected with ILR in 25.5% of patients
AF was associated with increasing age, interatrial conduction block, left atrial volume, the occurrence of atrial premature contractions.
The median (range) of monitoring prior to AF detection was 48 (0–154) days.
RelatoreNote di presentazioneExtension of the ECG monitoring time could lead to an increased AF detection rate in this patient population
Sinha A. et al. Am Heart J 2010; 160: 36‐41
RelatoreNote di presentazioneExtension of the ECG monitoring time could lead to an increased AF detection rate in this patient population
How to detect occult paroxysmal AF
ILR in cryptogenic stroke
Yield ranges ???
Implantable loop recorders(extension of ECG monitoring for up to 3 years)
RelatoreNote di presentazioneExtension of the ECG monitoring time could lead to an increased AF detection rate in this patient population
ILR in (silent) atrial fibrillation detection
How to detect occult paroxysmal AF
ILR in cryptogenic stroke
Yield ranges ???
Implantable loop recorders(extension of ECG monitoring for up to 3 years)
RelatoreNote di presentazioneExtension of the ECG monitoring time could lead to an increased AF detection rate in this patient population
58
15 (26%)
Total pts with ILR
Spontaneous episode documented by ILR
Results: ILR diagnosis
Follow‐up 20±13 months
33 (57%)
Arrhythmic syncopeNND: 4
Asystole of 6 s (IQR 4‐10) in 12 pts
- sinus arrest in 11 pts- AV block in 1 pt
Tachyarrhytmias in 3 pts
‐ectopic atrial tachycardia in 1 pt- atrial fibrillation in 1 pt
- ventricular tachycardia in 1 pt
RelatoreNote di presentazioneA specific ILR-guided therapy was administered in the 15 patients with arrhythmic syncope: pacemaker in 11, antiarrhythmic drugs in 3 and reduction of hypotensive drugs in 1 patient. These patients were followed up for 22±20 months: syncope recurred in 2/11 patients on pacemaker therapy and in 3/4 patients on other therapies.
Diagnosis after ILRClinical evalution and conventional tests
Suspected EPILEPSYn=28
Unexplained FALLn=29
No arrhythmia (epilepsy or non‐
arrhythmic syncope)n=9 (16%)
Arrhythmic syncope
n=15 (26%)
No arrhythmia (fall or non‐arrhythmic
syncope)n=9 (16%)
ILR‐undocumentedn=25 (43%)
9
7
11
9
13
8
Pseudo‐syncopen=1
1
Follow‐up 20±13 months
RelatoreNote di presentazioneDuring 20±13 months of follow-up, 34 (59%) patients had T-LOC recurrence; 33 of these (57%) had a spontaneous event documented by ILR: asystole in 12 (20%) patients, tachyarrhythmia in 3 (5%), no arrhythmia in 18 (31%).The diagnosis of syncope was established by ILR documentation of an arrhythmia in 15 (26%) patients: asystole was documented at the time of the spontaneous event in 7 patients with initial suspicion of epilepsy and in 5 patients with unexplained fall
58
15 (26%)
Total pts with ILR
Spontaneous episode documented by ILR
Pacemaker 11 pts
Results: ILR‐specific therapy
Follow‐up 20±13 months
Other therapies4 pts
33 (57%)
Arrhythmic syncope
Follow‐up 22±20 months
2 ptsRecurrence of syncope 3 pts
NND: 4
RelatoreNote di presentazioneA specific ILR-guided therapy was administered in the 15 patients with arrhythmic syncope: pacemaker in 11, antiarrhythmic drugs in 3 and reduction of hypotensive drugs in 1 patient. These patients were followed up for 22±20 months: syncope recurred in 2/11 patients on pacemaker therapy and in 3/4 patients on other therapies.
ILR provides an additional diagnostic value in “difficult” patients with initialdiagnosis of non syncopal T-LOC:
• 57% of patients with an initial diagnosis of either likely epilepsy orunexplained fall had ILR documentation of a relapse of their index attack
• in 26% patients, the final diagnosis was of arrhythmic syncope
• in the other 31% of patients, in whom no arrhythmia was documented atthe time of a spontaneous attack, ILR monitoring definitely excluded anarrhythmic cause.
Conclusion
ILR potentially usefull in:
• non syncopal T‐LOC (epilepsy/ unexplained fall/pseudo‐syncope)• recurrent palpitations• atrial fibrillation• stroke• risk stratification in arrhythmogenic disease• vasospastic angina
RelatoreNote di presentazioneThe aim of this study was to evaluate the diagnostic value of ILR in order to definitely confirm/exclude an arrhythmic mechanism, thus helping in distinguishing between syncope and epilepsy and syncope and fall.
“Difficult cases” of patients who had initially undergoneevaluation for T‐LOC of suspected epileptic or fall nature by otherspecialists (i.e., neurologists, geriatrists, internists) who raised thesuspicion of an alternative diagnosis of arrhythmic syncopebecause:
1. aspecific presentation (and the lack of historical information dueto retrograde amnesia) of the episodes , or
2. the presence of competing abnormalities/diagnoses makedifferential diagnosis challenging
Inclusion criteria
• recurrent palpitations• atrial fibrillation• stroke• risk stratification in arrhythmogenic disease• vasospastic angina
EHRA position paper. Brignole M. et al – Europace 2009
RelatoreNote di presentazioneThe aim of this study was to evaluate the diagnostic value of ILR in order to definitely confirm/exclude an arrhythmic mechanism, thus helping in distinguishing between syncope and epilepsy and syncope and fall.
ILR in Arrhythmogenic disease
Nostro paziente con Brugada e ILR
BrugadaARVDVentricolo non compattoRipolarizzazione precocePost‐infarto miocardico acutoCardiopatie congenite
Bortnik M. International Scholarly Research Network, 2011, Article ID 146062
Suboptimal device contact
ILR case
RelatoreNote di presentazioneTransitory signal loss because of suboptimal device contact with the subcutaneous tissue, probably due to a small swelling for a minimal pocket haematomaInternational Scholarly Research Network, 2011, Article ID 146062, 3 pages. Inappropriate Asystole Detection in Early Postoperative Phase after Loop Recorder Implantation. Miriam Bortnik, Eraldo Occhetta, Andrea Magnani, Anna Degiovanni, and Paolo Marino
Amplifier saturation
ILR case
RelatoreNote di presentazioneFig 2
V V V VV[V] [V]
RelatoreNote di presentazioneFig3
True events (ISSUE class) Pts False events PtsType 1 – Asystole >3 s 11 (23%) False asystole 20 (43%)
Type 2 – Bradycardia
Take home message (I) • Learn to recognize artifacts and false arrhythmias
Continuous ECG monitoringDiagnosis of Unexplained Syncope
ECG monitoring and syncope
Electrocardiographic monitoring in syncope:Indications
Class I, B
• ECG monitoring is indicated in patients who have clinical or ECG features suggesting arrhythmic syncope
Class I, B
• An early phase of evaluation in pts with recurrent syncope of uncertain origin, no high risk criteria and high likelihood of recurrence
ESC Guidelines on Management of Syncope – Update 2009
Class I, B
• High risk patients in whom a comprehensive evaluation did not demostrate a cause of syncope or lead a specific treatment
RelatoreNote di presentazioneNevertheless, data on ILR in the literature in this setting are limited to case reports and small series (4,5,6,7,8,9,10) and its diagnostic role is still unclear and undefined. As consequence, also recommendations of guidelines are scarce. In the 2009 version of guidelines on syncope of the European Society of Cardiology, non-syncopal T-LOC is not considered a definite indication for ILR
RelatoreNote di presentazioneIl monitoraggio elettrocardiografico è uno strumento diagnostico che viene utilizzato con lo scopo di confermare o escludere bradiaritmie o tachiaritmie intermittenti come causa di sincope.Attualmente sono disponibili diversi sistemi di monitoraggio: ………………………..In generale si può dire che il monitoraggio ECG è indicato quando vi è una elevata probabilità pre-test di identificare una aritmia responsabile della sincope.
ILR: non‐established indication• Risk stratification
‐ Previous myocardial infarction‐ Inherited diseases
• Atrial Fibrillation: ILR‐guided therapy• Cryptogenic stroke
RelatoreNote di presentazioneSo the first step is to identify the patient with syncope at high risk of major event who are, at least initially, to excluded in the prolonged monitoring.This patients require immediate in hospital evaluation in order to make risk stratification and immediate therapy if possible.These patients require prompt hospitalization or intensive evaluation
Initial evaluation
Certaindiagnosis
TLOC - suspected syncope
No furtherevaluation
Uncertain diagnosis
Treatment
Syncope TLOC - non syncopal
Confirm withspecific test or specialist’sconsultancy
Risk stratification*
High risk** Low risk, recurrent syncopes
Low risk, single or rare
Early evaluation
& treatment
Delayed treatmentguided by ECG documentation
Cardiac or neurally-mediatedtests as appropriate
Treatment
* May require laboratory investigations ** Risk of short-term serious events
ILR
ILR
ILR?
ESC Guidelines on Management of SyncopeVersion 2009
Diapositiva numero 1Diapositiva numero 2Diapositiva numero 3Diapositiva numero 4Diapositiva numero 5Laboratory investigationsDiapositiva numero 7Diapositiva numero 8Diapositiva numero 9CARISMA - ResultsBradyarrhythmiaTachyarrhythmiaPrognostics of Cardiac Death by ILR Risk stratification guided by ILR observations: post-MIDiapositiva numero 15Diapositiva numero 16Diapositiva numero 17Diapositiva numero 18Diapositiva numero 19Diapositiva numero 20Diapositiva numero 21Diapositiva numero 22Diapositiva numero 23ILR and Brugada�Risk stratification guided by ILR observations: Inherited diseasesDiapositiva numero 26Diapositiva numero 27Diapositiva numero 28Diapositiva numero 29Diapositiva numero 30Diapositiva numero 31Diapositiva numero 32Diapositiva numero 33Diapositiva numero 34Diapositiva numero 35Diapositiva numero 36Diapositiva numero 37Diapositiva numero 38Diapositiva numero 39Brugada SyndromeDiapositiva numero 41Diapositiva numero 42Long-term follow-up of prophylactic ICD in Brugada syndrome�Sarkozy A, et al. Eur Heart J 2007: 28, 334–344 Diapositiva numero 44Diapositiva numero 45ILR and Brugada�Diapositiva numero 47Diapositiva numero 48Diapositiva numero 49Diapositiva numero 50Diapositiva numero 51Symptom-AF correlation: drug studySymptom-AF correlation: cardioversionSymptom-AF correlation: pacemaker diagnosticsDiapositiva numero 55Diapositiva numero 56Diapositiva numero 57Diapositiva numero 58Diapositiva numero 59Diapositiva numero 60Diapositiva numero 61Diapositiva numero 62Diapositiva numero 63Diapositiva numero 64ILR: non conventional indicationsILR in Recurrent PalpitationDiapositiva numero 67Diapositiva numero 68ILR in Vasospastic anginaDiapositiva numero 70Diapositiva numero 71ILR in Arrhythmogenic Disease�(risk stratification)Diapositiva numero 73Diapositiva numero 74Diapositiva numero 75Diapositiva numero 76Diapositiva numero 77ILR in atrial fibrillation detection �after TIA or StrokeILR in cryptogenic strokeYield ranges from 1-5%ILR in cryptogenic strokeILR in cryptogenic strokeDiapositiva numero 83Diapositiva numero 84ILR in cryptogenic strokeILR in (silent) atrial fibrillation detection ILR in cryptogenic strokeDiapositiva numero 88Diapositiva numero 89Diagnosis after ILRDiapositiva numero 91Diapositiva numero 92Diapositiva numero 93ILR potentially usefull in:Diapositiva numero 95Diapositiva numero 96ILR in Arrhythmogenic diseaseDiapositiva numero 98Diapositiva numero 99Diapositiva numero 100Diapositiva numero 101Diapositiva numero 102Diapositiva numero 103Diapositiva numero 104Diapositiva numero 105Diapositiva numero 106Diapositiva numero 107Diapositiva numero 108Diapositiva numero 109