Post on 08-Feb-2018
transcript
Andrea Ungar, MD, PhD, FESC
Syncope Unit, Hypertension CentreGeriatric Cardiology and Medicine
University of Florence, Italy
L’evoluzione negli anni
ILFUTUROPROSSIMOILFUTUROPROSSIMO
ILFUTUROPROSSIMOILFUTUROPROSSIMO
Connessione wireless
La sincope
Situations in which ILR is proved to be useful (1):Situations in which ILR is proved to be useful (1):§ Patients with bundle branch block in whom a paroxysmal AV block is likely
despite a negative electrophysiological evaluation;
§ Patients with definite structural heart disease in whom an arrhythmia is likely despite a negative cardiological work-up;
§ Patients with cardioinhibitory carotid sinus hypersensitivity when the understanding of the exact mechanism of spontaneous syncope is needed to guide a specific therapy;
§ In pediatric patients in whom a cardiac cause of syncope is suspected due to structural heart disease or electrocardiographical abnormalities.
Situations in which ILR is proved to be useful (2):Situations in which ILR is proved to be useful (2):§ Patients in whom epilepsy was suspected but the treatment has proved
ineffective and in patients with established epilepsy in order to detect periictal cardiac arrhythmias that require treatment;
§ Patients with major depressive diseases and frequent recurrent unexplained episodes of LOC in order to exclude an arrhythmic cause of syncope;
§ In older patients with non-accidental falls to establish the syncopal nature of the event.
Recommendations: Electrocardiograhic monitoringRecommendations: Electrocardiograhic monitoring
• Il monitoraggio è diagnostico se vi è una correlazione tra sintomo e aritmia
• In assenza di correlazione sono diagnostici un blocco atrioventricolare avanzato, una pausa ventricolare > 3 secondi, o una tachicardia atriale ad elevata frequenza
• Le altre aritmie asintomatiche non hanno rilievo diagnostico
• La bradicardia sinusale in assenza di sintomi non è indicativa della causa di sincope
• La presincope non è diagnostica
ISSUE 3
SYNCOPE
ISSUE3International Study on Syncope of Uncertain Etiology 3
Background
ISSUE3International Study on Syncope of Uncertain Etiology 3
ISSUE 3
SYNCOPE
Total51centers,504patients
ISSUE 3
SYNCOPEIssue3Registry
Ptsaffectedbysevere,recurrentreflexsyncopes,aged>40yrs
ILRimplantation(RevealDX/XT)
ILRfollow-up(max2yrs)
ILRscreeningphase
ISSUE3therapyphase Diagnosis&ILR-guidedspecifictherapy
Follow-up
0
.1
.2
.3
.4
.5
.6
.7
.8
.9
1
Free
dom
from
dia
gnos
is
0 6 12 18 24 30 36Months
504 343 278 238 151 37 15 Number at risk
31%40%
47%
ISSUE 3
SYNCOPEDiagnosis
NND:2.1
0.00
0.10
0.20
0.30
0.40
0.50
0.60
0.70
0.80
0.90
1.00
Free
dom
from
syn
copa
l rec
urre
nce
62 42 35 29 23 19 16 14PM86 63 57 46 44 35 30 22NO PM
Number at risk
0 3 6 9 12 15 18 21Months
27%vs54%at21monthslogrank:p=0.01
RRR(hazardratio):57%NNT:3.7
PM(n=62)
NoPM(n=86)
ISSUE 3
SYNCOPE
PacemakertherapyvsnopacemakertherapyinestablishedNMSpatients
Recurrenceofsyncope
To compare the diagnosis of NMS madeat initial evaluation and with TT withthat obtained with the documentation ofa spontaneous event made byimplantable loop recorder (ILR)
Aimofthestudy
UngarA.etal,heart2013
NMSatinitialevaluation ILRimplantation504
DiagnosisafterECGdocumentation
Follow-up:15±11months
187(37%)
HypotensiveNMS
63(34%)
AsystolicNMS
99(53%)
Intrinsiccardiac
arrhythmias21(11%)
Non-arrhythmic
T-LOC4(2%)
NMSlikely162(87%)
NMSexcluded25(13%)
ISSUE 3
SYNCOPEDiagnosis
UngarA.etal,heart2013
ISSUE 3
SYNCOPEDiagnosis
Intrinsiccardiacarrhythmias21(11%)
Non-arrhythmicT-LOC4(2%)
NMSexcluded25(13%)
• longpausepost-tachyarrhythmia[#8]• paroxatrialfibrillation [#3]• AVNRT[#3]• persistentbradycardia[#3]• ventriculartachycardia[#4]
• non-syncopalT-LOC[#3],• orthostatichypotension [#1]
UngarA.etal,heart2013
Characteristics NMS n=162
Cardiacn=21
P value
Age, mean 64 68 nsMen 46% 62% nsSyncope events:
- Total events, median 8 5 ns- Events last 2 years, median 4 4 ns- Events last 2 years without prodrome, median 3 3 ns- Age at first syncope, mean 48 53 ns- Interval between first and last episode, median 9 5 ns- History of presyncope 55% 48% ns- Hospitalization for syncope 42% 57% ns- Injuries related to fainting:
- Major (fractures, concussion) 11% 5% ns- Minor (bruises, contusion, hematoma) 44% 43% ns
- Typical vasovagal/situational presentation 49% 43% ns- No prodromes 54% 67% ns
ISSUE 3
SYNCOPE
Factors predicting intrinsic cardiac syncope (I)Ungar A. et al, heart 2013
Characteristics NMS n=162
Cardiacn=21
P value
Tilt testing: performed 84% 81% ns- Positive of those performed 56% 47% ns
Medical history- Structural heart disease 12% 10% ns- Atrial tachyarrhythmias 5% 38% 0.001- Hypertension 50% 49% ns- Diabetes 11% 10% ns- Neurologiacal/psychiatric 4% 0% ns
Echocardiogram- Any abnormality 8% 10% ns
Concomitant medications- Anti-hypertensive 48% 29% ns- Psychiatric 12% 0% ns- Any other drugs 27% 33% ns
ISSUE 3
SYNCOPE
Factors predicting intrinsic cardiac syncope (II)Ungar A. et al, heart 2013
Tilttest+ ILR+
28
48
Asystole(Vasis2B)
MorVD(Vasis1,2A,3)
Asystole47
29 Slightrhythmvariations
24(86%)
4(14%)
23(48%)
25(52%)
Total76pts
Positivepredictivevalueofasystolictilt:0.86(95%CI0.70-0.95)
ISSUE 3
SYNCOPE
CorrelationbetweentilttestresponsesandILR-documentedmechanism
UngarA.etal,heart2013
M.M. female, 74 years old
Hypertension, Hypercholesterolemia; Depressive syndrome. May 2009, an episode of transient global amnesia;Since 2009 epileptic absences, EEG confirmed; the patient start therapy with levetiracetam;Since 2009 several recurrent falls, sometimes traumatic.March 2012: Syncope Unit: Orthostatic Hypotension.June/July 2012: two falls with consequent mild trauma and some suspected presyncopal episodes. We decided to implant a Loop recorder08-19-2012: dizziness episode with fall after a
prolonged orthostatic period, without prodromal symptoms, with consequent fall and occipital trauma……..
M.M. female, 74 years old
• The Insertable Cardiac Monitor
supraventricular tachycardia, 200 bpm, lasting 39 seconds, during the loss of consciousness
La diagnosi differenzialecon alter TPdC
Additional diagnostic value of implantable loop recorder in patients with initial diagnosis of non-syncopal transient loss of consciousness
Maggi R, Rafanelli M, Ceccofiglio A, Solari D, Brignole M, Ungar A
Europace 2014
Patients’ characteristicsPatients’ characteristicsTotalptsn=58
Suspectedepilepsy(*)
n=28
Unexplainedfallsn=29
Meanage,yrs 71± 17 64±18 78±8
Males 25(43%) 17(63%) 7(25%)
Mediannumber ofT-LOCbeforeimplantation 4.6±2.3 3.7±2.1 5.5±3.3
Competingabnormalities/diagnoses: 29(50%) 14(50%) 15(52%)
- Structuralheartdisease 16(28%) 5(18%) 11(38%)
- Bundlebranchblock 10(17%) 4(14%) 6(20%)
- Positivetilttesting 10/41(17%) 8(29%) 2(7%)
- Carotidsinushypersensitivity 6/49(10%) 2(7%) 4(14%)
Europace 2014
Results:ILRdiagnosisResults:ILRdiagnosis58
15 (26%)
Total pts with ILR
Spontaneous episode documented by ILR
Follow-up 20±13 months
33 (57%)
Arrhythmic syncopeNND: 4
Asystole of 6 s (IQR 4-10)
-sinus arrest, 11 pts- AV block, 1 pt
Tachyarrhythmia
-ectopic atrial tachycardia, 1 pt-atrial fibrillation, 1 pt- ventricular tachycardia, 1 pt
12 3
Europace 2014
Diagnosis after ILRClinical evalution andconventional tests
SuspectedEPILEPSYn=28
UnexplainedFALLn=29
No arrhythmia(epilepsy or non-
arrhythmic syncope)n=9 (16%)
Arrhythmicsyncope
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
Europace 2014
ConclusionConclusion
ILR provides an additional diagnostic value in “difficult”patients with initial diagnosis of non syncopal T-LOC:• 57% of patients with an initial diagnosis of either likelyepilepsy or unexplained fall had ILR documentation of arelapse of their index attack;• in 26% patients, the final diagnosis was of arrhythmicsyncope;• in the other 31% of patients, in whom no arrhythmia wasdocumented at the time of a spontaneous attack, ILRmonitoring definitely excluded an arrhythmic cause..
Europace 2014
La fibrillazione atriale
INdicationS fordiaGnosis,ArrhytHmia andMoniToring ofRevealXT
INSIGHT-XT
Observational multicentre study thatenrolled patients inserted with an insertable cardiac monitor (ICM) for arrhythmia diagnosis or monitoring in real life
Totalrecruitedn=1003
Dataavailablen=997
Availableforanalysesn=975
• Noimplant/Baseline data n=6
• In-/Exclusion criterianotmet n=22
Atleast1follow-up availablen=968
• Losttofollow-up n=7
Fullpo
pulatio
n
12months* follow-up availablen=779
• PatientreceivesanICD,PMorCRT-devicen=103• RevealXTexplanted n=36• Losttofollow-up n=30• Patientdeath n=8• Patientrequestedwithdrawalfromthestudy n=8• Investigatorwithdrewpatientfromthestudy n=1• Otherreasons n=3
*Morethan300days
Patient Disposition
INdicationS fordiaGnosis,ArrhytHmia andMoniToring ofRevealXTINSIGHT-XT
INSIGHT-XTEnrollmentTotal Enrollments per Country
214
141
115
53
27 26 20 19 19 13 11 11 9 5 2 00
50
100
150
200
250
German
y
Netherlan
ds
Russia
Austria
Switzerl
and
Italy
Spain
Czech
Rep
ublic
Finlan
d
Portug
al
Slovac R
epub
lic
United Arab E
mirates
Belarus
Slovenia
Sweden
Belgium
968INSIGHT-XTpatientsforindication
391
172
284
121
0
50
100
150
200
250
300
350
400
450
Syncope/ Presyncope
AF ablation management
Other indication Cryptogenic stroke (incl. Palpitations)
Primary Indication
PatientCharacteristicsSyncopeorPre-
syncope(N=391)
AFpatients
(N=327)
CryptogenicStroke
(N=121)
Other(N=129)
Total(N=968)
Demographics
Male %, n/Pts 50.1%(196/391) 65.7%(220/335) 52.9%(64/121) 47.9%(58/121) 55.6%(538/968)Age at first implant (years) 63.0± 16.6 59.9± 11.0 62.4± 13.2 57.5± 16.5 61.1± 14.5Medical historyAT/AF history %, n/Pts 18.4%(72/391) 87.5%(293/335) 0.0%(0/121) 18.2%(22/121) 40.0%(387/968)Coronary artery disease %, n/Pts 6.4%(25/391) 7.8%(26/335) 71.9%(87/121) 4.1%(5/121) 14.8%(143/968)Prior Myocardial Infarction %, n/Pts 7.2%(28/391) 5.7%(19/335) 5.0%(6/121) 7.4%(9/121) 6.4%(62/968)Prior Transient Ischemic Attack %,n/Pts
4.6%(18/391) 6.0%(20/335) 35.5%(43/121) 3.3%(4/121) 8.8%(85/968)
Prior CVA/Stroke%, n/Pts 4.6%(18/391) 6.3%(21/335) 71.1%(86/121) 3.3%(4/121) 13.3%(129/968)Hypertension %, n/Pts 60.9%(238/391) 68.1%(228/335) 62.0%(75/121) 54.5%(66/121) 62.7%(607/968)Diabetes %, n/Pts 15.3%(60/391) 12.5%(42/335) 11.6%(14/121) 10.7%(13/121) 13.3%(129/968)Hypercholesterolemia%, n/Pts 33.5%(131/391) 33.4%(112/335) 52.9%(64/121) 38.0%(46/121) 36.5%(353/968)CHADS ≥ 3 %, n/Pts 16.4%(64/391) 16.8%(55/327) 67.8%(82/121) 14.0%(18/129) 22.6%(219/968)CHADSVASC ≥ 4 %, n/Pts 31.5%(123/391) 26.6%(87/327) 60.3%(73/121) 24.8%(32/129) 32.5%(315/968)
Patientscharacteristics
PatientCharacteristicsSyncopeorPre-
syncope(N=391)
AFpatients
(N=327)
CryptogenicStroke
(N=121)
Other(N=129)
Total(N=968)
Demographics
Male %, n/Pts 50.1%(196/391) 65.7%(220/335) 52.9%(64/121) 47.9%(58/121) 55.6%(538/968)Age at first implant (years) 63.0± 16.6 59.9± 11.0 62.4± 13.2 57.5± 16.5 61.1± 14.5Medical historyAT/AF history %, n/Pts 18.4%(72/391) 87.5%(293/335) 0.0%(0/121) 18.2%(22/121) 40.0%(387/968)Coronary artery disease %, n/Pts 6.4%(25/391) 7.8%(26/335) 71.9%(87/121) 4.1%(5/121) 14.8%(143/968)Prior Myocardial Infarction %, n/Pts 7.2%(28/391) 5.7%(19/335) 5.0%(6/121) 7.4%(9/121) 6.4%(62/968)Prior Transient Ischemic Attack %,n/Pts
4.6%(18/391) 6.0%(20/335) 35.5%(43/121) 3.3%(4/121) 8.8%(85/968)
Prior CVA/Stroke%, n/Pts 4.6%(18/391) 6.3%(21/335) 71.1%(86/121) 3.3%(4/121) 13.3%(129/968)Hypertension %, n/Pts 60.9%(238/391) 68.1%(228/335) 62.0%(75/121) 54.5%(66/121) 62.7%(607/968)Diabetes %, n/Pts 15.3%(60/391) 12.5%(42/335) 11.6%(14/121) 10.7%(13/121) 13.3%(129/968)Hypercholesterolemia%, n/Pts 33.5%(131/391) 33.4%(112/335) 52.9%(64/121) 38.0%(46/121) 36.5%(353/968)CHADS ≥ 3 %, n/Pts 16.4%(64/391) 16.8%(55/327) 67.8%(82/121) 14.0%(18/129) 22.6%(219/968)CHADSVASC ≥ 4 %, n/Pts 31.5%(123/391) 26.6%(87/327) 60.3%(73/121) 24.8%(32/129) 32.5%(315/968)
Patientscharacteristics
Patientscharacteristics
MedicationsSyncopeorPre-
syncope(N=391)
AFpatients
(N=327)
CryptogenicStroke(N=121)
Other(N=129)
Total(N=968)
Antiarrhytmicdrugs
Antiarrhythmics (overall),n/Pts 41.9%(164/391) 87.5%(286/327) 31.4%(38/121) 57.4%(74/129) 58.1%(562/968)
AAClassI,n/Pts 4.1%(16/391) 21.7%(71/327) 1.7%(2/121) 11.6%(15/129) 10.7%(104/968)
Beta-blockers,n/Pts 34.5%(135/391) 54.7%(179/327) 29.8%(36/121) 48.8%(63/129) 42.7%(413/968)
Sotalol,n/Pts 2.0%(8/391) 11.3%(37/327) 0.8%(1/121) 2.3%(3/129) 5.1%(49/968)
AAClassIII,n/Pts 4.1%(16/391) 28.4%(93/327) 0.8%(1/121) 0.8%(1/129) 11.5%(111/968)
Amiodaron,n/Pts 3.6%(14/391) 22.9%(75/327) 0.8%(1/121) 0.8%(1/129) 9.4%(91/968)
OtherAAClassIII,n/Pts 0.5%(2/391) 5.8%(19/327) 0.0%(0/121) 0.0%(0/129) 2.2%(21/968)
OACorAntiplatelets
OACorAntiplatelets,n/Pts 51.2%(200/391) 85.6%(280/327) 97.5%(118/121) 54.3%(70/129) 69.0%(668/968)
OAC,n/Pts 12.0%(47/391) 64.2%(210/327) 5.0%(6/121) 13.2%(17/129) 28.9%(280/968)
Antiplatelets,n/Pts 40.2%(157/391) 27.5%(90/327) 93.4%(113/121) 42.6%(55/129) 42.9%(415/968)
Patientscharacteristics
SymptomsatbaselineSyncopeorPre-
syncope(N=391)
AFpatients
(N=327)
CryptogenicStroke(N=121)
Other(N=129)
Total(N=968)
Any symptom*, n/Pts 97.2%(380/391) 91.1%(298/327) 33.9%(41/121) 93.8%(121/129) 86.8%(840/968)Palpitations, n/Pts 20.7%(81/391) 63.6%(208/327) 12.4%(15/121) 69.0%(89/129) 40.6%(393/968)Dizziness/Lightheaded/Pre-syncope,n/Pts
33.0%(129/391) 17.7%(58/327) 13.2%(16/121) 38.0%(49/129) 26.0%(252/968)
Syncope, n/Pts 84.4%(330/391) 5.8%(19/327) 6.6%(8/121) 27.9%(36/129) 40.6%(393/968)Dyspnea, n/Pts 10.2%(40/391) 42.2%(138/327) 5.8%(7/121) 27.1%(35/129) 22.7%(220/968)Fatigue, n/Pts 8.4%(33/391) 41.6%(136/327) 2.5%(3/121) 18.6%(24/129) 20.2%(196/968)Chest pain, n/Pts 9.5%(37/391) 16.8%(55/327) 3.3%(4/121) 17.8%(23/129) 12.3%(119/968)
FU durationSyncopeorPre-syncope(N=391)
AFpatients
(N=327)
CryptogenicStroke(N=121)
Other(N=129)
Total(N=968)
Follow-upduration[months,Median(QI-
QIII)]15(10- 23) 16(12- 26) 13(12- 13)
15(12-24)
14(11- 23)
968INSIGHT-XTpatientsforindication
391
172
284
121
0
50
100
150
200
250
300
350
400
450
Syncope/ Presyncope
AF ablation management
Other indication Cryptogenic stroke (incl. Palpitations)
Primary Indication
AtrialfibrillationinpatientsimplantedwithReveal-XTforSyncope
INdicationS fordiaGnosis,ArrhytHmia andMoniToring ofRevealXT
INSIGHT-XT
Results– AFprevalence
Resultsonsyncopepatientswithatleast30daysoffollowupavailable
Insight-XTSyncope andAF,preliminary data
Results– AFprevalence
• 18%ofthesyncopepatients hadahistoryofAFatstudyenrollmentand57%(n=28)ofthesehadAFduringthestudy
• 82% ofthesyncopepatientshadnopriorhistoryofAFatenrollmentand16%(n=34) ofthesehadnewlydiagnosedAFduringthestudy
Insight-XTSyncope andAF,preliminary data
391
172
284
121
0
50
100
150
200
250
300
350
400
450
Syncope/ Presyncope
AF ablation management
Other indication Cryptogenic stroke (incl. Palpitations)
Primary Indication
968INSIGHT-XTpatientsforindication
The median time to diagnosis of AF was 100 days after ICM insertion
AF was observed in 19.8% (1Q-3Q: 11.7% -13.4%) of patients (n=24) during a median follow-up time of 12.5 months
Managing cryptogenic stroke patients using insertable cardiac monitors:Results of the INSIGHT XT study
Anti-thrombotic medication at last follow-up in patients diagnosed with AF
OAC therapy was started in 62.5% of the patients who were diagnosed with AF during the study and allpatients with AF received some type of anti-thrombotic medication
Preliminary data on diagnosis in total population
DIAGNOSIS1. VT
2. AF/AFlutter (incl.AF,AFlutter,Brady-Tachy)
3. AT(incl.ATandAVNRT)
4. SinusTachycardia
5. SinusArrest/Bradycardia
6. HighergradeAVblock(incl.2ndand3rddegreeAVblock)
In 63.1% of patients enrolled Reveal-XT obtain clinical useful data for the management of the patients
Patientswith diagnosis by reveal-xt
Overall% (n)N=968
Syncope orPre-syncope
% (n)N=391
AF patients% (n)N=327
CryptogenicStroke% (n)N=121
Other% (n)N=129
No diagnosis during FU 36.9%(357) 36.6%(143) 27.5%(90) 62.8%(76) 37.2%(48)
At least 1 diagnosis during FU 63.1%(611) 63.4%(248) 72.5%(237) 37.2%(45) 62.8%(81)
Preliminary data on total population
Grazie per l’attenzione
Atrial fibrillation was asymptomatic in 23 of 29 first episodes in the ICM group(79%) and in 2 of 4 first episodes in the control group (50%).
97.0% of patients in whom atrial fibrillation had been detected were receiving oral anticoagulants