Subcutaneous Electrocardiographic (ECG) Monitoring Device. Patients with infrequent short duration transient symptoms, recurring over months

Subcutaneous Electrocardiographic (ECG) Monitoring Device Patients with infrequent short duration transient symptoms, recurring over months RETROSPECTIVE (LOOP) MEMORY Continuously records and deletes

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Subcutaneous Electrocardiographic (ECG) Monitoring Device Patients with infrequent short duration transient symptoms, recurring over months RETROSPECTIVE (LOOP) MEMORY Continuously records and deletes the patient s Patient-activation function ECG and auto activation (daily automatic) transmissions for pre-specified criteria. Capture of arrhythmic events without relying on patient compliance or perception of symptoms Reveal Plus ICM Reveal DX Reveal XT ICM : Sensing Onda R Soglia fissa Soglia dinamica Risposta alle interferenze Soglia dinamica Risposta alle interferenze Trigger episodi Asistolia, Bradicardia, Tachicardia Asistolia, Bradicardia VT/FVT Asistolia, Bradicardia VT/FVT, AT/AF Diagnostica estesa no no AF detection Burden AT/AF, HRV, Attività del paziente, FC Diurna/Notturna, Cardiac Compass Sistema di mappaggio Cardboard Vector Check Vector Check Interfaccia utente No Medtronic standard Medtronic ICD style Medtronic ICD style Durata 14 mesi 3 anni 3 anni Memorizzazione Eventi 42 min min min. Patient Assistant Singola funzione: Sintomo Doppia funzione: Sintomo e feedback 3 funzioni: Sintomo, Feedback e query Risonanza magnetica no Si Si Remote Monitoring no Medtronic CareLink Network Medtronic CareLink Network 6 CARATTERISTICHE VALORE 18,5 mm 8 mm 56,3 mm Dimensioni (altezza x larghezza x spessore) Volume Peso Longevità stimata 56,3 mm x 18,5 mm x 8 mm 6,5 cc 12 g 3 anni Gli elettrodi sottocutanei sul dispositivo semplificano la procedura di impianto ed eliminano la necessità di utilizzare elettrodi transvenosi Posizionamento degli elettrodi appositamente studiato per avere un riconoscimento migliore degli episodi grazie ad un buon contatto tra sensore e tessuto Elettrodo frontale Elettrodo retro 7 SJM Confirm Implantable Cardiac Monitor (ICM) Patient Activator Merlin Patient Care System (PCS) Transtelephonic service provider Uses the same interval, interval average algorithm that ICDs use to bin or classify intervals as Tachy, Brady or Asystole. A weekly trend based on the percentage of time the patient spent in atrial fibrillation based on the AF duration programmed in parameters. Will also be displayed on the FastPath Provides the mean ventricular rate during AF and a histogram of recorded AF episode durations Provides a link to the AF Diagnostics screen. 2014 Parameter Longevity Long Wide WEIGH Electrode Spacing (inside-to-inside) Volume Mass Episode Storage Patient Symptom Mark Cardiac Compass MRI Compatibility Clinician Notification Bi-Directional Telemetry Detection Algorithms CareLink Network Wireless Telemetry Reveal LINQ ICM *3 years 7.2 mm 4.0 mm thick 2.5 g 38 mm 1.2 cc 2.5 g 59 min Patient Assistant Same MR Conditional Nightly Transmission / CareAlert Notifications B Full View + P-SENSE detection Yes 1-Way, Transmit Only Insertable Automatic transmission AF detection P-sense Cardiac Compass Electrodes on the ends of the device record ECG signals An embedded accelerometer measures patient activity Uses wireless telemetry for remote monitoring of patients (including nightly automated transmissions) LINQ Device + Tool di Incisione Tool di inserzione 87% PIU PICCOLO DEL Reveal XT Benefici della miniaturizzazione 12 TECHNOLOGICAL ADVANCES Simplify implantation procedure Increase patient acceptance Enhance the device s AF detection capabilities. 13 New Frontiers in Cardiac Monitoring Reveal LINQ e Trasmissione Wireless Carelink Network No Segnalazione Disponibili: i Dati Device, 10 sec di ECG Corrente ed i contatori Disponibili 30 sec di ECG trasmesso nella lista episodi Ogni 31 gg, un Summary Report verrà comunque generato con i Dati Device, i 10 sec di ECG Corrente e contatori dall ultima trasmissione, Trend e Cardiac Compass : Cellular CareAlerts Segnalazione con un Event Report, contenente Dati Device (i.e. Batteria) 30 s di ECG di un Episodio, secondo le priorità impostate Numero Episodi Patient Assistant Selezionare la Ragione del Monitoraggio: Sincope Palpitazioni Convulsioni Tachicardia ventricolare AF sospetta Ablazione AF Gestione AF Ictus criptogenetico Altro La scelta del motivo del monitoraggio permette una preselezione della programmazione più specifica 17 11-MONTH-OLD boy with tuberous sclerosis with frequent ventricular arrhythmias secondary to cardiac Rhabdomyomas. Its smaller size makes it much more suitable for children and infants It is technically easy to implant Automatic transmission to CareLink Ideal for patients asymptomatic who require constant monitoring 18 Cardiology in the Young (2015), 25, Conclusions: The miniaturized Reveal LINQ ICM supports arrhythmia detection and monitoring, achieving adequate sensing performance without safety issues Heart Rhythm, Vol 12, No 6, June Incidence of AF episodes Duration of AF Cumulative time spent in AF (AF burden) Ventricular rate during AF Average Day Night Heart Rate Heart Rate Variability Patient Activity Can store up to 14 AF episodes with electrocardiogram (ECG) data after which the earliest episode gets overwritten by newer episodes m false positive Duration 55% Number of 46% Pu rerfellner H, Heart Rhythm 2014; 11: Symptom- Rhythm Correlation -Management of transient loss of consciousness (T-LOC) -Evaluation of syncope Management of Palpitations Silent Atrial Fibrillation In patients with frequent recurrences of unexplained syncope, the 2009 European Society of Cardiology (ESC) guidelines now advocate the early use of ILRs. Prospective, Multicenter, observational study 570 pts with recurrent unexplained presyncope or syncope ILR provided a diagnosis in 78% of the patients WITH 3 YEAR BATTERY LIFE OFFERS THE BEST OPPORTUNITY FOR DIAGNOSIS 22 Task Force Brignole et al. Europace (2009) 11, Suggested ECG monitoring techniques depending on symptom frequency Diagnosing bradyarrhythmic syncope after the initial evaluation: most useful tests Non-invasive evaluation of patients with suspected or known ventricular arrhythmias 441 pts N Engl J Med 2014;370: Implantable REVEAL XT Device Conventional Monitoring Time ICM (%) Control (%) Hazard Ratio P End Point Primario 6 months End Point Secondario 12 months Dramatic increase in the detection rate (30% versus 3%) of atrial fibrillation at 36 months. 3 years ILRs is safe and cost- effective and has a high diagnostic yield Maximizes clinical benefits while simultaneously lowering costs or improving economic Diagnose Atrial Fibrillation Tachycardia Predict Bradycardia Heart Failure Treat Manage 2015 Heart Rhythm, Vol 12, No 7, July 2015
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