REVEAL AF IN YOUR CRYPTOGENIC STROKE PATIENTS

Transcription

1 REVEAL AF IN YOUR CRYPTOGENIC STROKE PATIENTS Reveal LINQ TM Insertable Cardiac Monitoring System Are You Looking Long Enough?

2 ONE-THIRD OF ISCHEMIC STROKES ARE CRYPTOGENIC (UNEXPLAINED) 1-6 HOW DO YOU MONITOR FOR AF IN YOUR CRYPTOGENIC STROKE PATIENTS? Each year, at least 200,000 cryptogenic strokes occur in the United States 7 Cryptogenic stroke accounts for approximately one-third of ischemic strokes in the majority of modern stroke registries and databases 1-6 Cryptogenic stroke is as prevalent as large vessel stroke 20% Cryptogenic Stroke 5% AF DETECTION AND TREATMENT MATTERS 15% Cryptogenic Stroke Large Vessel Small Vessel Other Cardioembolic 2016 ESC Guidelines for the management of atrial fibrillation 11 Guidelines developed by the Task Force for the management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC Endorsed by the European Stroke Organisation (ESO) Guidelines Recommendation In stroke patients, additional ECG monitoring by long-term noninvasive ECG monitors or implanted loop recorders should be considered to document silent atrial fibrillation. Class IIa Level B 5-FOLD 2X 67% increase in ischemic stroke risk for AF patients. 8 more likely for AF-related ischemic stroke to be fatal as non-af stroke. 9 decrease in AF patient stroke risk with oral anticoagulants. 10 AF detection and monitoring modality selection matters for cryptogenic stroke patients The ability to identify AF in patients with cryptogenic stroke has profound implications for long-term medical management 12 Recurrence was more frequent and functional deficits were more likely to be severe among survivors of AF-related ischemic stroke 9 Guidelines also recommend anticoagulant therapy for stroke prevention in most patients with AF 13

3 ARE YOU MONITORING CRYPTOGENIC STROKE PATIENTS LONG ENOUGH? Short- and intermediate-term cardiac monitoring may miss many patients with paroxysmal AF 14 INFORM YOUR CLINICAL DECISIONS WITH THE REVEAL LINQ ICM SYSTEM Up to 3 YEARS of continuous cardiac monitoring The world s smallest insertable cardiac monitor AF episode Repeated short-term monitoring DIAGNOSIS OF CRYPTOGENIC STROKE Long-term, continuous monitoring (up to 3 years) Median time to detect AF following cryptogenic stroke: DAYS The revolutionary Reveal LINQ Insertable Cardiac Monitoring System transforms your ability to diagnose atrial fibrillation with its proven AF detection algorithm Simple, minimally invasive insertion procedure 30 days 12 months 24 months 36 months Short-term monitoring (up to 1 week) Intermediate-term monitoring (up to 30 days) Note: Illustration purposes only The Reveal LINQ ICM is placed just under the skin of the patient s chest in a simple procedure The ultra-discreet heart monitor is not visible in most patients Patients prefer the Reveal LINQ ICM over external wearable monitors 15 Safe for use in MRI setting same day at 1.5 and 3.0 Tesla* *Reveal LINQ ICM has been demonstrated to pose no known hazards in a specified MRI environment with specified conditions of use. Please see the Reveal LINQ ICM clinician manual or MRI technical manual for more details. 84 DAYS is the median time to AF detection in cryptogenic stroke patients 14 79% of first AF episodes were asymptomatic at 12 months 14 88% of patients who had AF would have been missed if only monitored for 30 days *14 The Reveal LINQ ICM continuously records heart rhythm data and sends them wirelessly to the MyCareLink TM Patient Monitor The MyCareLink Patient Monitor transmits data from the Reveal LINQ ICM to the clinic via a global cellular connection The clinic receives easy-to-use and clinically actionable Reveal LINQ reports via the CareLink TM Network *Based on Kaplan Meier estimates.

4 THE CRYSTAL-AF STUDY DEMONSTRATES THE SUPERIORITY OF ICM FOR AF DETECTION IN PATIENTS WITH CRYPTOGENIC STROKE 13 As published in the New England Journal of Medicine 14 STUDY DESIGN PATIENT INCLUSION CRITERIA END POINTS Randomized, controlled clinical trial with 441 patients Compared continuous, long-term monitoring with Reveal ICM vs. conventional follow-up Assessment at scheduled and unscheduled visits ECG monitoring performed at the discretion of the site investigator 40 years of age Cryptogenic stroke (or clinical TIA) with infarct seen on MRI or CT within the previous 90 days and no mechanism identified after: 12-lead ECG 24-hour ECG monitoring (e.g., Holter) Transesophageal echocardiography CTA or MRA of head and neck to rule out arterial source Screening for hypercoagulable states in patients < 55 years old Primary Time to first detection of AF at 6 months of follow-up Secondary Time to first detection of AF at 12 months of follow-up Recurrent stroke or TIA Actions taken after patient diagnosed with AF CRYSTAL-AF study results Atrial Fibrillation Detected (% of patients) # at risk Control ICM Hazard ratio, 8.8 (95% CI, ) P < by log-rank test 6.4X 8.9% 1.4% 12.4% 2% Months since randomization Reveal ICM Control more AF detected at 6 months: 8.9% in ICM group vs. 1.4% in control 7.3X more AF detected at 12 months: 12.4% in ICM group vs. 2.0% in control 6.4X 7.3X 8.8X 8.8X 3% more AF detected at 36 months: in ICM group vs. 3.0% in control The CRYSTAL-AF Study found that continuous monitoring with Reveal ICM is superior to standard medical care for the detection of AF in cryptogenic stroke patients. Visit CRYSTAL-AF.com for complete study information. Clinical impact: More appropriate care Short-term cardiac monitoring is NOT sufficient for AF detection in cryptogenic stroke Extensive external monitoring found few patients with AF In the control group at 6 months, only 3 patients were found to have AF; yet there were 88 conventional ECGs, hour Holters, and 1 event recorder used Reveal ICM detected over 7 times more patients with AF at the 12-month end point

5 ISCHEMIC STROKE PATHWAY CRYPTOGENIC STROKE PATHWAY Lacunar infarction: small vessel disease Standard stroke work-up Ischemic Stroke/TIA Embolic appearing stroke with no history of AF: Multiple foci of infarction Cortical watershed distribution Cerebellar Standard stroke work-up History of AF Standard stroke work-up Patient Diagnosed with Cryptogenic Stroke/TIA Could detection of suspected AF impact patient management? YES NO Not a candidate Antiplatelet agent MRA or CTA of intracranial vessels Transesophageal Echocardiogram (TEE) Anticoagulation Refer to cardiology to insert Reveal LINQ ICM Symptomatic carotid stenosis greater than 50% CEA or stent Intracranial stenosis Positive TEE Anticoagulant All testing negative? Inpatient If unable to insert prior to discharge, potential external monitor bridge and schedule Reveal LINQ ICM Insert Reveal LINQ ICM prior to discharge Inpatient/outpatient insertion Insert expeditiously Outpatient Bridge with external monitor Monofocal Multifocal Enroll in CareLink Network & perform remote monitoring AF not detected AF detected Medical management Antiplatelet agents Angiogram Lumbar puncture Vasculitis work-up Schedule clinical follow-up with treating physician and ensure long-term adherence to monitoring Insert Reveal LINQ ICM Standard stroke work-up: Carotid dopplers Glucose control Telemetry bed Blood pressure management Fasting lipid panel Hypercoagulation labs if age < 50 Pathway based on the consensus of the Cryptogenic Stroke Pathway steering committee. February Used with permission from Matthew C. Holtzman, MD. Neurology Michigan P.C. This pathway represents Dr. Holtzman s clinical practice. Medical judgment should be used to determine if adopting pathway is appropriate. Medtronic Disclosure Statement: This pathway is provided for educational purposes and should not be considered the exclusive source for this type of information. It is the responsibility of the practitioner to exercise independent clinical judgment. Refer to the brief statement for indications, warnings/precautions, and complications for the Reveal LINQ ICM.

6 References 1 Sacco RL, Ellenberg JH, Mohr JP, et al. Infarcts of undetermined cause: the NINCDS Stroke Data Bank. Ann Neurol. April 1989;25(4): Petty GW, Brown RD Jr, Whisnant JP, Sicks JD, O Fallon WM, Wiebers DO. Ischemic stroke subtypes: a population-based study of incidence and risk factors. Stroke. December 1999;30(12): Kolominsky-Rabas PL, Weber M, Gefeller O, Neundoerfer B, Heuschmann PU. Epidemiology of ischemic stroke subtypes according to TOAST criteria: incidence, recurrence, and long-term survival in ischemic stroke subtypes: a population-based study. Stroke. December 1, 2001;32(12): Schulz UG, Rothwell PM. Differences in vascular risk factors between etiological subtypes of ischemic stroke: importance of population-based studies. Stroke. August 2003;34(8): Schneider AT, Kissela B, Woo D, et al. Ischemic stroke subtypes: a population-based study of incidence rates among blacks and whites. Stroke. July 2004;35(7): Lee BI, Nam HS, Heo JH, Kim DI, Yonsei Stroke Team. Yonsei Stroke Registry. Analysis of 1,000 patients with acute cerebral infarctions. Cerebrovasc Dis. 2001;12(3): American Heart Association. Heart Disease and Stroke Statistics, 2015 Update. Available at: General/Heart-and-Stroke-Association-Statistics_UCM_319064_SubHomePage.jsp. Accessed April 12, Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation: a major contributor to stroke in the elderly. The Framingham Study. Arch Intern Med. September 1987;147(9): Lin HJ, Kelly-Hayes M, Beiser AS, et al. Stroke Severity in Atrial Fibrillation: The Framingham Study. Stroke. 1996; 27: Stroke Prevention in Atrial Fibrillation Study. Final results. Circulation. August 1991;84(2): Kirchhof P, Benussi, S, Kotecha D, et al ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J. Published online August 27, Accessed online August 31, 2016 at: early/2016/08/26/eurheartj.ehw Kernan WN, Ovbiagele B, Black HR, et al. Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. July 2014;45(7): January CT, Wann LS, Alpert JS, et al AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. December 2, 2014;64(21):e Sanna T, Diener HC, Passman RS, et al. Cryptogenic stroke and underlying atrial fibrillation. N Engl J Med. June 26, 2014;370(26): Reveal LINQ Usability Study. Data on file. Medtronic, Inc Brief Statement Indications Reveal LINQ LNQ11 Insertable Cardiac Monitor and Patient Assistant The Reveal LINQ Insertable Cardiac Monitor is an implantable patient-activated and automatically-activated monitoring system that records subcutaneous ECG and is indicated in the following cases: Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias Patients who experience transient symptoms such as dizziness, palpitation, syncope, and chest pain, that may suggest a cardiac arrhythmia This device has not specifically been tested for pediatric use. Patient Assistant The Patient Assistant is intended for unsupervised patient use away from a hospital or clinic. The Patient Assistant activates the data management feature in the Reveal Insertable Cardiac Monitor to initiate recording of cardiac event data in the implanted device memory. Contraindications There are no known contraindications for the implant of the Reveal LINQ Insertable Cardiac Monitor. However, the patient s particular medical condition may dictate whether or not a subcutaneous, chronically implanted device can be tolerated. Warnings/Precautions Reveal LINQ LNQ11 Insertable Cardiac Monitor Patients with the Reveal LINQ Insertable Cardiac Monitor should avoid sources of diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, therapeutic ultrasound, and radiofrequency ablation to avoid electrical reset of the device, and/or inappropriate sensing as described in the Medical procedure and EMI precautions manual. MRI scans should be performed only in a specified MR environment under specified conditions as described in the Reveal LINQ MRI Technical Manual. Patient Assistant Operation of the Patient Assistant near sources of electromagnetic interference, such as cellular phones, computer monitors, etc., may adversely affect the performance of this device. Potential Complications Potential complications include, but are not limited to, device rejection phenomena (including local tissue reaction), device migration, infection, and erosion through the skin. Medtronic MyCareLink Patient Monitor, Medtronic CareLink Network and CareLink Mobile Application Intended Use The Medtronic MyCareLink Patient Monitor and CareLink Network are indicated for use in the transfer of patient data from some Medtronic implantable cardiac devices based on physician instructions and as described in the product manual. The CareLink Mobile Application is intended to provide current CareLink Network customers access to CareLink Network data via a mobile device for their convenience. The CareLink Mobile Application is not replacing the full workstation, but can be used to review patient data when a physician does not have access to a workstation. These products are not a substitute for appropriate medical attention in the event of an emergency and should only be used as directed by a physician. CareLink Network availability and mobile device accessibility may be unavailable at times due to maintenance or updates, or due to coverage being unavailable in your area. Mobile device access to the Internet is required and subject to coverage availability. Standard text message rates apply. Contraindications There are no known contraindications. Warnings and Precautions The MyCareLink Patient Monitor must only be used for interrogating compatible Medtronic implantable devices. See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at and/or consult the Medtronic website at Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

7 Reveal LINQ TM Insertable Cardiac Monitoring System 2016 ESC AF Guidelines recommend cardiac monitoring with Reveal LINQ ICM for cryptogenic stroke patients. *11 *Endorsed by the European Stroke Organisation The CRYSTAL-AF Study found that continuous monitoring with Reveal ICM is superior to standard medical care for the detection of AF in cryptogenic stroke patients. Visit CRYSTAL-AF.com for complete study information. 84 Days is the median time to AF detection in cryptogenic stroke patients 13 ARE YOU LOOKING LONG ENOUGH? AF-Detection Rate at 3 Years 13 INFORM YOUR CLINICAL DECISIONS Medtronic 710 Medtronic Parkway Minneapolis, MN USA Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. All other brands are trademarks of a Medtronic company. Toll-free in USA: Worldwide: medtronic.com UC d EN 2016 Medtronic. Minneapolis, MN. All Rights Reserved. Printed in USA. 09/2016