La strategia diagnostica: il monitoraggio ecg prolungato Michele Brignole
ECG monitoring and syncope In-hospital monitoring Holter Monitoring External loop recorder Remote (at home) telemetry Implantable loop recorder
ECG monitoring and syncope In-hospital monitoring Holter Monitoring External loop recorder Remote (at home) telemetry Implantable loop recorder Same positivity Criteria
ECG monitoring and syncope Positivity criteria 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 2 nd or 3 rd degree AV block during waking state - rapid paroxysmal atrial/ventricular tachycardia Correlation between syncope and sinus rhythm excludes arrhythmic syncope
ECG monitoring and syncope Diagnostic power In-hospital monitoring 1-7 Holter Monitoring 1-7 External loop recorder 30 Implantable loop recorder 500
Utility of in-hospital telemetry in patients with suspected arrhythmic syncope
The diagnostic yield of tests is high if appropriate indications are selected EGSIS 2 study. European Heart Journal (2006) 27, 76 82
V-Patch
External loop recorder Linzer et al AJC 1996 Schuchert et al PACE 2003 Symptom frequency End-point Monitoring duration Diagnostic value Median 10/year (>1/month in 70%) Pre-syncope or syncope <1/month (3±4 last 6 mos) Syncope 4 weeks 6 weeks 25% 4% Linzer M et al. Am J Cardiol 1990; 66: 214-9 Schuchert A et al. PACE 2003; 26: 1837-1840
Key points to select patients for ILR Exclude high risk patients Include only those patients with a high probability of recurrence of syncope in a reasonable time period Be prepared to wait even for a long time before obtaining a diagnosis
TLOC - suspected syncope Initial evaluation Syncope TLOC - non syncopal Certain diagnosis Treatment High risk** Early evaluation & treatment Uncertain diagnosis Risk stratification* Low risk, recurrent syncopes Delayed treatment guided by ECG documentation Cardiac or neurally-mediated tests as appropriate Low risk, single or rare No further evaluation Confirm with specific test or specialist s consultancy Treatment * May require laboratory investigations ** Risk of short-term serious events
Risk stratification. Short-term high risk criteria which require immediate hospitalization or early intensive evaluation as appropriate Situations in which there is a clear indication for ICD or pacemaker treatment independently of a definite diagnosis of the cause of syncope according to recent ICD-CRT guidelines (insert references) Severe structural cardiovascular or coronary artery disease (heart failure or low ejection fraction or previous myocardial infarction) Clinical or ECG features suggesting an arrhythmic syncope: - Syncope during exertion or supine - Palpitations at the time of syncope - Family history of sudden death - Non-sustained ventricular tachycardia - Bundle branch block (QRS duration 0.12 sec) - Inadequate sinus bradycardia (<50 bpm) or sinoatrial block in the absence of negatively chronotropic medications and physical training - Pre-excited QRS complexes - Prolonged or short QT interval - Right bundle branch block pattern with ST-elevation in leads V1-V3 (Brugada syndrome) - Negative T waves in right precordial leads, epsilon waves and ventricular late potentials suggestive of arrhythmogenic right ventricular dysplasia Important comorbidities (severe anemia, electrolytic disturbance, etc)
SYNCOPE ISSUE Adverse Events Pooled ISSUE 1 and ISSUE 2 results (total 590 patients) 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%) No syncope-related death
Risk of recurrence of syncope after the index episode Number of syncopes during life Actuarial risk 1 year Actuarial risk 2 years Estimated risk 4 years 1-2 15% 20% 28% 3 37% 42% 52% 4-6 37% 44% 57% 7-10 37% 44% 56% >10 44% 56% 81% Risk of recurrence of syncope after the index episode Number of syncopes during last 2 years Actuarial risk 1 year Actuarial risk 2 years Estimated risk 4 years 1-2 23% 28% 37% 3 29% 36% 49% 4-6 43% 51% 66% 7-10 43% 49% 60% >10 86% 98% 100% Pooled data of 590 patients >40 years from ISSUE 1 & 2 studies
Probability of syncope recurrence after target evaluation (in patients with recurrent syncope) All patients n= 590 Cumulative probability 75% <4 years (predicted) 50% <2 years 33% 10% <1 year <1 month Font: Pooled ISSUE 1 & 2 database, unpublished
Mechanism of syncope in patients with unexplained syncope Pooled data from 9 studies (total 506 pts) Normal SR 33% 56% Asystole/ Bradycardia 11% Tachycardia Diagnostic yield: 176/506 (35%)
Pre syncopal events (total 109) No arrhythmia Asystole/ Bradycardia Tachycardia
Diagnosis by ILR (mean FU 14±10 months) SHD n=38 No SHD n=65 Total diagnosis 22 (58%) 30 (45%) ns Parox AV block 13 (34%) 8 (13%) 0.01 Brady/sinus arrest 2 (5%) 11 (15%) 0.07 Atrial tachy 3 (8%) 0 (0%) 0.05 Ventricular tachy 2 (5%) 0 (0%) n.s. No arrhythmia 2 (5%) 11 (17%) 0.07 Solano et al. Eur Heart J 2004; 25: 1116-9 p
Diagnosis by ILR (mean FU 14±10 months) Age >65 n=78 Age<65 n=25 Total diagnosis 44 (56%) 8 (32%) 0.03 No rhythm variation 10 (13%) 3 (12%) ns Arrhythmias: 34 (44%) 5 (20%) 0.03 - Parox AV block 18 (23%) 3 (12%) ns - Brady/sinus arrest 11 (14%) 2 (8%) ns - Atrial tachy 3 (4%) 0 (0%) ns - Ventricular tachy 2 (3%) 0 (0%) ns. Brignole et al. Europace 2005; 7: 273-279 p
Implantable loop recorder When to use it? Both in SHD and no SHD More useful in the elderly Currently largely underused
ILR and syncope: Indications Class I In an initial phase of the work-up in patients with recurrent syncopes, absence of high risk criteria and a likely recurrence within battery longevity of the device Mechanism unclear after full evaluation and clinical/ecg features suggesting an arrhythmic cause Class II To assess the contribution of bradycardia before embarking on cardiac pacing in patients with suspected or certain neurally-mediated syncope presenting with frequent or traumatic syncopal episodes ESC Guidelines on Management of Syncope
TLOC - suspected syncope Initial evaluation Syncope TLOC - non syncopal Certain diagnosis Treatment High risk** Early evaluation & treatment ILR Uncertain diagnosis Risk stratification* Low risk, recurrent syncopes ILR Cardiac or neurally-mediated tests as appropriate Delayed treatment guided by ECG documentation Low risk, single or rare No further evaluation Confirm with specific test or specialist s consultancy ILR? Treatment * May require laboratory investigations ** Risk of short-term serious events
SYNCOPE ISSUE 2 Results: Pacemaker therapy Eur Heart J 2006; 27, 1085 1092 100% Phase II PM 80% Syncope free survival 60% 40% 20% PM vs No therapy: p=0.0005 HR=0.20 (95%CI, 0.07-0.55) PM vs No PM: p=0.002 HR=0.10 (95% CI, 0.02-0.43) No brady Brady, No PM 0% 0 90 180 270 360 Days 450 540 630 720 No. at risk PM 47 45 38 31 23 18 12 6 5 No ther 36 24 19 13 9 7 5 1 1 No PM 13 8 5 2 2 1 1 1 1
SYNCOPE ISSUE 2 Results: Syncope burden Episodes per patient/year 0.83 RRR: -92% p=0.002 RRR: -94% p=0.001 0.07 0.05 Non-specific Rx ILR-based specific Rx Pacemaker Eur Heart J 2006; 27, 1085 1092
Pacemaker in pts with asystolic syncope Krahn et al. Europace (2007) 9, 312 318 Recurrence after Pm Not 1A/1B Syncope per year Syncope burden Before After 4.57 1A/1B 2.17 0.45 0.00 1A/1B not 1A/1B n=14 n=16
Implantable Loop Recorder: Therapy guided by ILR observations Key points Cardiac pacing is the most frequent specific therapy guided by ILR observations Cardiac pacing is higly effective in reducing syncope burden However, syncope still sometimes recurs especially in NMS patients