INSERTABLE CARDIAC MONITORS FROM ATRIAL FIBRILLATION TO SYNCOPE:

Transcription

1 INSERTABLE CARDIAC MONITORS FROM ATRIAL FIBRILLATION TO SYNCOPE: Established and emerging clinical evidence demonstrates the utility of insertable cardiac monitors (ICMs) in diagnosing a variety of suspected arrhythmias.

2 SUSPECTED ATRIAL FIBRILLATION Approximately 2% of people younger than age 65 have AFib, while about 9% of people aged 65 years or older have AFib. 2 AF is not life threatening in itself, but is a progressive condition. Left untreated, AF can worsen and the increase in side effects may lead to stroke or heart failure. 3 People with AF are five times more likely to experience a stroke. 4 Estimates of the prevalence of AF in the United States ranged from approximatley 2.7 million to 6.1 million in 21 and AF prevalence is estimated to rise to 12.1 million in 23. 3,5,6 In the European Union, the prevalence of AF in adults > 55 years of age was estimated to be 8.8 million in 21 and was projected to rise to 17.9 million in DETECTION OF ATRIAL FIBRILLATION DETECT-AF Study The 9 patient DETECT-AF study compared an implantable loop recorder to a holter monitor and found: 8 AF episodes at least two minutes in length were accurately detected 8 94% episode sensitivity 8 AF MANAGEMENT ABACUS Study ABACUS study: More Patients Properly Detected and More Decisions Made with ICM After Catheter Ablation 9 96% of patient s AF episodes were detected by their ICM. 9 Conventional Monitoring missed 29% in first 6 months. 9 Rate control and anti-arrhythmic drugs were discontinued more in the ICM arm. 9 Asymptomatic AF documented in 7% of patients. 9 The Rhythm Evaluation for Anticoagulation with Continuous Monitoring (REACT.COM) Continuous rhythm assessment with an ICM allows for targeted anticoagulation (3 day dosage for AF episode 1 hour) without compromising stroke risk: 1 94% reduction in total time on novel oral anticoagulants (NOACs). 1 Differences in AF Detection Over Time Antiarrhythmic Drug Discontinuation ILR CM % ILR Conventional Monitoring Percent of Patients Months 1-6 Months 6-12 Percent of Patients % 56% 56% 3% 2% ADD Initial ADD 6 Months ADD 12 Months

3 ATRIAL FIBRILLATION (AF) IS THE MOST COMMON TYPE OF HEART ARRHYTHMIA. 1

4 CRYPTOGENIC STROKE Long term monitoring using Cardiac Monitors is now part of the 216 ESC guidelines for the management of Atrial Fibrillation. 11 Recommendation Class Level In stroke patients, additional ECG monitoring by long-term noninvasive ECG monitors or implanted loop recorders should be considered to document silent atrial fibrillation. IIa B CRYSTAL-AF Study Continuous monitoring using an ICM better detects AF in cryptogenic stroke patients versus standard monitoring. 12 AF detection using an ICM was 84 days (median). 12 At one year, an ICM detected AF in 7.3 times more patients than standard monitoring. 12 Detection of Atrial Fibrillation by 6 Months Atrial Fibrillation Detected (% of patients) No. at Risk Control ICM Months since Randomization Hazard ratio, 6.4 (95% CI ) P <.1 by log-rank test ICM Control ICM Control PALPITATIONS Palpitations alone usually are not harmful, but, sometimes, they can signal a dangerous arrhythmia. In 16% of patients, the etiology of palpitations is unknown. 13 In 43% of patients, palpitations are caused by a heart condition. 13

5 Insertable Cardiac Monitor UNEXPLAINED SYNCOPE 217 ACC/HRS/AHA guidelines now recommend the use of implantable cardiac monitors for patients with syncope. 14 Syncope additional evaluation and diagnosis Initial evaluation: history, physical exam, ECG (Class I) Initial evaluation clear Initial evaluation unclear Stress testing TTE No evaluation evaluation needed* Targeted blood testing Initial evaluation suggests neurogenic OH Initial evaluation suggests reflex syncope Initial evaluation suggests CV abnormalities Options EPS Referral for autonomic evaluation Tilt-table testing Cardiac monitor selected based on frequency and nature (Class I) MRI or CT Options Implantable cardiac monitor Ambulatory external cardiac monitor Time to Recurrence Percent of Subjects with an Event Estimate of Time to Syncopal Episode Time to Syncopal Episodes Where Reveal ICM Played a Role in Diagnosis An ICM aids in diagnosing the cause of recurrent syncope in 78% of patients. 15 Within one year, 36% of patients who experience a syncope event will have a recurrence. 15 Of the 78% of patients who received a cardiac-related diagnosis for syncope: 15 51% were prescribed a pacemaker. 15 6% were prescribed an ICD. 15 Days after Implant

6 1. National Stroke Association. AFib-stroke connection. Published 216; Accessed November 11, Centers for Disease Control and Prevention. (215). Atrial fibrillation fact sheet. Accessed May 8, Go, A. S., Hylek, E. M., Phillips, K. A., Chang, Y., Henault, L. E., Selby, J. V., & Singer, D. E. (21). Prevalence of diagnosed atrial fibrillation in adults. National implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) study. Journal of the American Medical Association, 285, Wolf, P. A., Abbott, R. D., & Kannel. W. B. (1991). Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke, 22(8), Miyasaka, Y., Barnes, M. E., Gersh, B. J., Cha, S. S., Bailey, K. R., Abhayaratna, W. P.,... Tsang TS. (26). Secular trends in incidence of atrial fibrillation in Olmsted County, Minnesota, 198 to 2, and implications on the projections for future prevalence. Circulation, 114(2), [published correction appears in Circulation, 26, 114, e498] 6. Krijthe, B. P., Kunst, A., Benjamin, E. J., Lip, G. Y., Franco, O. H., Hofman, A.,... Heeringa, J. (213). Projections on the number of individuals with atrial fibrillation in the European Union from 2 to 26. European Heart Journal, 34(35), Colilla, S., Crow, A., Petkun, W., Singer, D. E., Simon, T., & Liu, X. (213). Estimates of current and future incidence and prevalence of atrial fibrillation in the U.S. adult population. American Journal of Cardiology, 112(8), Nölker, G., Mayer, J., Boldt, L. H., Seidl, K., VAN Driel, V., Massa, T.,... Lewalter, T. (216). Performance of an implantable cardiac monitor to detect atrial fibrillation: results of the DETECT AF study. Journal of Cardiovascular Electrophysiology, 27(12), Hindricks, G., Piorkowski, C., Tanner, H., Kobza, R., Gerds-Li, J. H., Carbucicchio, C., & Kottkamp, H. (25). Perception of atrial fibrillation before and after radiofrequency catheter ablation: relevance of asymptomatic arrhythmia recurrence. Circulation, 112(3), Passman, R., Leong-Sit, P., Andrei, A. C., Huskin, A., Tomson, T. T., Bernstein, R.,... Zimetbaum, P. (216). Targeted anticoagulation for atrial fibrillation guided by continuous rhythm assessment with an insertable cardiac monitor: the Rhythm Evaluation for Anticoagulation with Continuous Monitoring (REACT.COM) pilot study. Journal of Cardiovascular Electrophysiology, 27(3): Kirchhof, P., Benussi, S., Kotecha, D., Ahlsson, A., Atar, D., Casadei, B.,... Vardas, P. (216). 216 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. European Heart Journal. Published online August 27, Accessed August 31, Sanna, T., Diener, H. C., Passman, R. S., Di Lazzaro, V., Bernstein, R. A., Morillo, C. A.,... Brachmann, J.; CRYSTAL AF Investigators. (214). Cryptogenic stroke and underlying atrial fibrillation (CRYSTAL AF). The New England Journal of Medicine, 37(26), Weber, B. E., & Kapoor, W. N. (1996). Evaluation and outcomes of patients with palpitations. American Journal of Medicine, 1(2), Shen, W. K., Sheldon, R. S., Benditt, D. G., Cohen, M. I., Forman, D. E., Goldberger, Z. D.,... Yancy, C. W. (217). 217 ACC/AHA/HRS Guideline for the evaluation and management of patients with syncope: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines, and the Heart Rhythm Society. Circulation. 217 Mar 9. [Epub ahead of print] 15. Edvardsson, N., Frykman, V., van Mechelen, R., Mitro, P., Mohii-Oskarsson, A., Pasquié, J. L.,... Linker, N. J.; PICTURE Study Investigators. (211). Use of an implantable loop recorder to increase the diagnostic yield in unexplained syncope: results from the PICTURE registry. Europace, 13(2): Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use. Unless otherwise noted, indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St. Jude Medical, LLC and its related companies. 217 St. Jude Medical, LLC. All Rights Reserved. St. Jude Medical LLC Global Headquarters One St. Jude Medical Drive St. Paul, MN USA T F St. Jude Medical S.C., Inc. Americas Division 63 Bee Cave Road Bldg. Two, Suite 1 Austin, TX USA T F SJM Coordination Center BVBA The Corporate Village Da Vincilaan 11-Box F1 B-1935 Zaventem, Belgium T F St. Jude Medical Brasil Ltda. Rua Itapeva, 538 5º ao 8º andares São Paulo SP Brazil T F St. Jude Medical (Hong Kong) Ltd. 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