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Luca Segreti UO Cardiologia 2 – Aritmologia
Direttore MG Bongiorni Azienda Ospedaliero Universitaria Pisana
Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)
Indicazioni all’utilizzo del loop recorder
Brignole M et al, Europace 2009 Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)
Indicazioni all’utilizzo del loop recorder
• Stabilire presenza di correlazione tra sintomi e ritmo cardiaco sincope.
• Ricercare alterazioni del ritmo in assenza di sintomi –> fibrillazione atriale.
Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)
Indicazioni all’utilizzo del loop recorder
• Stabilire presenza di correlazione tra sintomi e ritmo cardiaco sincope.
• Ricercare alterazioni del ritmo in assenza di sintomi –> fibrillazione atriale.
Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)
LOOP RECORDER NELLA DIAGNOSI DI SINCOPI INSPIEGATE
SINCOPE: Perdita di coscienza per ridotto flusso sanguigno cerebrale
• INCIDENZA:
da 1.3 a 2.7 casi per 1000 persone l’anno; E’ più elevata nei più anziani (81 per 1000/anno nei >80 anni).
Fino al 40% della popolazione ha almeno una sincope nella sua vita1,2.
• CAUSE:
.
1 Savage DD, et al. The Framingham Study. Stroke. 1985;16(4):626-629.
2 Chen L et al. The Framingham Heart Study. Am J Cardiol. 2000;85(10):1189-1193.
3 Soteriades ES, et al. N Engl J Med. 2002;347(12):878-885
4 Edvardsson et al. the PICTURE registry. Europace. 2011;13(2):262-269.
Sincope Neuromediata, Ortostatica, Cardiaca, Cerebrovascolare, Inspiegata (37%3)
La sincope Cardiaca:
è comune,
Rischio di morte
> % di mortalità a 6 mesi3
Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)
La diagnosi è importante per trovare la cura e evitare le recidive (>35% sono sincopi traumatiche)4
• DIAGNOSI:
Sulke N, et al. Europace (2016) 18, 912–918 Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)
50% ILR patients achieved an ECG diagnosis within a mean of 95.2 days.
Only 17% patients without ILRs who achieved an ECG diagnosis (P , 0.001).
Sulke N, et al. Europace 2016
ILR patients were less likely to have a second post-randomization syncope (HR 0.38). No significant difference between
CONV and SC patients
Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)
Sincope inspiegata
Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)
Brignole M et al, Europace 2009
Diagnosi di sincope non certa, ma solo sospettata
• Pazienti con epilessia, ma con trattamento inefficace
• Pazienti anziani che presentano cadute non accidentali inspiegabili
• Pazienti con gravi malattie depressive ed episodi inspiegabili di sincope
Solbiati M, et al. Cochrane Database of Systematic Reviews 2016
Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)
Sanjiv Petkar, et al. Europace 2012
Ancora non ben spiegati nella popolazione epilettica: • Le sincopi frequenti • L’alta frequenza di morte improvvisa
E’ importante diagnosticare l’origine cardiaca di una sincope convulsiva per: • Evitare un trattamento anticonvulsivante non indicato • Valutare la presenza di aritmia ipocinetica nei pz con persistente sincope nonostante terapia Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)
Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)
EXPENSIVE INVASIVE
Indicazioni all’utilizzo del loop recorder
• Stabilire presenza di correlazione tra sintomi e ritmo cardiaco sincope.
• Ricercare alterazioni del ritmo in assenza di sintomi –> fibrillazione atriale.
Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)
Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)
2 fold in women and 1.5 in men
Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)
Oral anticoagulation (OAC) with vitamin K antagonists (VKAs) or non- VKA oral anticoagulants (NOACs) markedly reduces stroke and mortality in AF patients. 1. Hart RG, et al. Ann Intern Med 2007 2. Ruff CT, et al. Lancet 2014
Other interventions such as rhythm control and rate control improve AF-related symptoms and may preserve cardiac function, but have not demonstrated a reduction in long-term morbidity or mortality. 3. Kirchhof P, et al. Am Heart J 2013 4. Al-Khatib SM, et al. Ann Intern Med 2014
ICM PER LA DIAGNOSI DI AF nell’ICTUS criptogenico
ICTUS: Deficit focale delle funzioni cerebrali
• INCIDENZA:
nel mondo 15 milioni di persone hanno un ictus ogni anno1;
5.7 milioni ogni anno muoiono e 5 milioni hanno disabilità permanenti1.
In Europa si contano 2 milioni di eventi nuovi o recidivanti ogni anno2,di cui circa 120 000 in ITALIA
.
IL PROBLEMA
1 World Heart Federation. http://www.world-heart-federation.org/cardiovascular-health/stroke/ 2 Truelsen T et al. Eur J Neurol. 2006; 13(6):581-98 3 Guercini Fet al. J Thromb Haemost. 2008;6(4):549-554.. 4 Wolf PA, et al.The Framingham study. Neurology. 1978;28(10):973-977. .
CAUSE1:
5 Wolf PA, et al. the Framingham Study. Stroke. 1991;22(8):983-988. 6 Wang TJ, et. Al The Framingham Heart Study. JAMA. 2003;290(8):1049-1056 7 Lin HJ et al. Stroke. 1996; 27:1760-1764.
Con FA ha probabilità doppia di essere fatale rispetto ad uno non associato ad FA7
%
CRIPTOGENICO3
L’FA ne è un importante predittore e ne aumenta il rischio di 5 volte4-6
Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)
Detection of atrial fibrillation in stroke survivors
• AF detection is not uncommon in unselected stroke patients (6.2%), but is more likely in patients with cryptogenic stroke implanted with loop recorders or who have had ECG monitor for several weeks.
• Sequential stratified ECG monitoring detected AF: • in 24% (95% CI 17–31) of stroke survivors, • and in 11.5% (95% CI 8.9%–14.3%) in another meta-analysis
• with large variations depending on the timing, duration, and method of monitoring.
• Cryptogenic stroke is defined as • a stroke in which the cause could not be identified after extensive investigations. • Embolic stroke of undetermined source.
Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)
Heart Rhythm 2015;12:234–241
Data suggest that silent AF is identified in approximately 30% of cryptogenic stroke patients and has important therapeutic implications.
Oral anticoagulation likely should be prescribed when silent AF is detected Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)
Cryptogenic Stroke and Underlying AF - CRYSTAL AF Randomized 441 pts to assess whether monitoring with an insertable cardiac monitor
(ICM) is more effective for detecting atrial fibrillation in patients with cryptogenic stroke
Sanna T, et al. Cryptogenic Stroke and Underlying Atrial Fibrillation (CRYSTAL AF). N Engl J Med. 2014; 370(26):2478-2486
Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)
Primary Endpoint: Detection of AF at 6 months
AF definition > 30 sec.
Cryptogenic Stroke and Underlying AF - CRYSTAL AF Randomized 441 pts to assess whether monitoring with an insertable cardiac monitor
(ICM) is more effective for detecting atrial fibrillation in patients with cryptogenic stroke
Sanna T, et al. Cryptogenic Stroke and Underlying Atrial Fibrillation (CRYSTAL AF). N Engl J Med. 2014; 370(26):2478-2486
Rate of detection in ICM arm was 8.4% vs 1.4% in control arm
at 6 months
Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)
Primary Endpoint: Detection of AF at 6 months
Perez-Rondon J et al. JAFIB 2015
6 m 8.4%
Temporal Proximity of Silent AF Episodes to Thromboembolic Event
Interestingly, the majority of patients (75%) did not show a temporal association with the detected atrial episode and their adverse event, with a mean bag period of 46.7+-71.9 days before the TE complication
Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)
• Several studies have also found AF in patients in whom another competing cause for stroke has been identified clinically (e.g. hypertension or carotid artery stenosis).
• Hence, prolonged ECG monitoring seems reasonable in all survivors of an ischaemic stroke without an established diagnosis of AF.
Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)
Evoluzione del loop recorder
Confirm Rx
Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)
Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)
PACE 2010; 33:999–1002
Benefici della miniaturizzazione
Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)
LINQ Device
Tool di inserzione Tool di Incisione
+
Maggiore accettazione da parte del paziente e confort
Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)
87% PIU’ PICCOLO
Migliore AF detection
Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)
1. Hindricks G et al. Circ Arrhythm Electrophysiol 2010
2. Sanders P, et al. Heart Rhythm. 2016
STUDY DEVICE Sensitivity % Specificity % PPV % NPV %
XPECT Study1 Reveal XT 96.1 85.4 79.3 97.4
LINQ Usability Study2 Reveal LINQ 97.4 97.0 92.5 99
Il 97% delle volte il Reveal LINQ identificherà correttamente AF. Quando il Reveal LINQ non trova AF, il 99% delle volte questa non è effettivamente presente.
Caratteristica BioMonitor 2-AF Reveal XT Reveal LINQ Confirm AF
Variante per la sincope BioMonitor 2 -S Reveal DX NO Confirm 2100
Dimensioni (lu-la-sp) 88 x 15 x 6 62 x 19 x 8 44,8 x 7,2 x 4 56,3 x 18,5 x 8
Volume (cc) 5 9 1,2 6,5
Peso (g) 10 15 2,5 12
Durata Batteria 4 anni 3 anni 3 anni 3 anni
Rilevazione QRS 88 mm 40 mm 38 mm 39 mm
Tempo tot Registrazioni > 60 min < 60 min 60 min < 60 min
Tempo per registrazione 55 x 40 s episodi 4 x 7.5 min episodi attivati dal paziente
27 min episodi 22.5 min episodi attivati dal paziente
27 min episodi 30 min episodi attivati dal paziente 2 min episodi lunghi AF
147 episodi
Gestione di memoria SMART First in, First out First in, First out (per tipo di episodio)
First in, First out
n. trasmissioni/die HM 6 NO 1 NO
Compatibilità RMN SI, 3 T SI, 3 T SI, 3 T SI, 1.5 T
Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)
I loop recorder sono dispositivi dotati di memoria retrospettiva: sono in grado cioè di registrare e cancellare continuamente la traccia elettrocardiografica.
Conclusions
• ILR technology has advanced • Devices are smaller, easy to implant
• Detection algorithms have improved
• Remote monitoring allows fast recognition of asymptomatic arrhythmias
• Use in evaluation of syncope is well established but still underused
• Role in detecting arrhythmias in situations where early recognition could lead to change in treatment and outcome
• Valuable tool in diagnosis of asymptomatic Afib in stroke patients
Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)
SINCOPE inspiegata che non richieda ospedalizzazione
Sincope neuromediata, da seduto
Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)
SINCOPE inspiegata che non richieda ospedalizzazione
Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)
EPILESSIA con sincope nonostante terapia anticonvulsivante
Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)
Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)
Ricerca della FIBRILLAZIONE ATRIALE post Ictus Ischemico
ECG Check