Make the Connection A clinical compendium on the relationship between AF, stroke, and early intervention

Transcription

1 Make the Connection A clinical compendium on the relationship between AF, stroke, and early intervention Data that date back to the 1970 s have illustrated the strong relationship between atrial fibrillation (AF) and stroke. Early detection of AF allows for early intervention. This clinical compendium highlights key studies that show: AF is related to stroke, devices with remote care enable early intervention, and early intervention allows for appropriate therapy to minimize the risk of stroke.

2 Atrial Fibrillation (AF) is related to an increased risk of stroke The following studies are key reports illustrating an increased risk of stroke for patients who have chronic AF, paroxysmal AF, and device detected subclinical atrial tachyarrhythmia. Chronic AF is related to an increased risk of stroke Epidemiologic Assessment of Chronic Atrial Fibrillation and Risk of Stroke: The Framingham Study 1 Wolf PA, et al. Neurology, The aim of this study was to determine if chronic AF predisposes stroke 5,184 men and women (age 30-62) were followed for 24 years and were evaluated for the development of stroke Rate of stroke was 5.6 times greater in individuals with chronic stroke than those who were free of AF (p<0.01) Atrial Fibrillation as an Independent Risk Factor for Stroke: The Framingham Study 2 Wolf PA, et al. Stroke, This study evaluated the relative impact of AF on the incidence of stroke in the Framingham Study 5,070 men and women free of cardiovascular disease (including AF) at study enrollment were examined every 2 years during a 34-year follow up Estimated relative risk of stroke for AF patients compared to those without AF was significant in all age groups (p<0.001, 4.0 for year old patients, 2.6 for year old patients, 3.3 for year old patients, and 4.5 for year old patients) The attributable risk of stroke from AF in the Framingham Study increased significantly with age (1.5 % for year old patients, 2.8% for year old patients, 9.9% for year old patients and 23.5% for year old patients) Attributable Risk of Stroke from AF: Framingham Study Percent Age

3 Atrial Fibrillation (AF) is related to an increased risk of stroke Paroxysmal AF is related to an increased risk of stroke Stroke in Paroxysmal Atrial Fibrillation: Report from Stockholm Cohort of Atrial Fibrillations 3 Friberg L, et al. New England Journal of Medicine, The aim of this study was to investigate whether there are differences in stroke risk between paroxysmal AF and permanent AF 855 patients with paroxysmal AF and 1,126 patients with permanent AF were followed for 3.6 years for incidence of stroke The incidence of stroke was similar between patients with paroxysmal and permanent AF Compared with the general population, stroke was twice as common in patients with paroxysmal AF Subclinical AF is related to an increased risk of stroke Subclinical Atrial Fibrillation and The Risk of Stroke 4 Healey JS, ASSERT Investigators, et al. New England Journal of Medicine, This study evaluated whether subclinical episodes of rapid atrial rate detected by implanted devices were associated with an increased risk of ischemic stroke in patients who did not have other evidence of atrial fibrillation 2,580 patients (65 years of age or older) with hypertension and no history of AF, in whom a pacemaker or implantable cardiac defibrillator was recently implanted were studied Patients were monitored for 3 months to detect subclinical atrial tachyarrhythmias (episodes of atrial rate > 190 beats per minute for more than 6 minutes) and were followed for 2.5 years for the primary outcome of stroke or systemic embolism The population attributable risk of ischemic stroke or systemic embolism associated with subclinical atrial tachyarrhythmia was 13% Subclinical atrial tachyarrhythmias were associated with an 2.49-fold increase risk of stroke or systemic embolism (p=0.007) and a 5.56-fold increase risk of clinical atrial fibrillation (p<0.001)

4 Devices with identification and timely notification of atrial fibrillation allow for early intervention Implanted devices allow the burden of AF to be assessed by tracking the number and duration of symptomatic and asymptomatic AF episodes. 5 Such devices coupled with remote care may allow notification of subclinical episodes to the physician or clinician which may result in early intervention and potentially improved outcomes. The following studies summarize the potential benefit of remote care. Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision Trial (CONNECT) 6 Crossley GH, et al. J Am Coll Cardiol, The primary objective of this multicenter, prospective, randomized trial was to determine if wireless remote monitoring with automatic clinician alerts reduces the time from a clinical event to a clinical decision in response to arrhythmias, cardiovascular disease progression, and device issues compared to patients receiving standard-in-office care. 1,997 patients from 136 sites who underwent implantation of an implantable cardioverterdefibrillator (including cardiac resynchronization therapy devices) were followed for 15 months The median time from clinical event to clinical decision per patient was reduced from 22 days in the in-office arm to 4.6 days in the remote arm (p < 0.001) Efficacy and Safety of Automatic Remote Monitoring for Implantable Cardioverter- Defibrillator Follow-Up: The Lumos-T Safely Reduces Routine Office Device Follow-Up (TRUST) Trial 7 Varma N, et al. Circulation, This randomized trial evaluated the safety and efficacy of home monitoring for implantable cardioverter defibrillator (ICD) follow up for 1-year 1,339 patients were randomized 2:1 to home monitoring or conventional follow-up (3, 6, 9, 12, and 15 months after implantation) Median time to evaluation was < 2 days in the home monitoring group compared to 36 days in the conventional (scheduled in-office follow-up) group (p<0.001) Long-Term Outcome After ICD and CRT Implantation and Influence of Remote Device Follow-Up: The ALTITUDE Survival Study 8 Saxon LA, et al. Circulation This study assessed the long-term survival and incidence of shock therapies in a large population of ICD and CRT device recipients enrolled in remote monitoring 69,556 patients were followed on the remote monitoring network and 124,450 patients were followed in-clinic only Annual and total survival was significantly better in patients who transmitted device information to the network (remote care) Comparative survival data for 10,272 matched patients implanted with ICD and CRT-D devices on and off the network showed that remote care was associated with a 50% relative reduction in the risk of death (p<0.001)

5 Early intervention with Appropriate pharmacological therapy in AF can reduce the risk of stroke Numerous clinical trials have provided an extensive evidence base for the use of antithrombotic therapy in AF. 9 A meta-analysis of 29 trials including 28,044 participants was conducted to characterize the efficacy of and safety of antithrombotic agents for stroke prevention in patients who have AF. Of these trials, 6 evaluated the effect of adjusted-dose warfarin and cumulatively showed that adjusted-dose warfarin reduced stroke by 64%. 10 TECHNOLOGY CORNER Accent RF Device with Remote Monitoring AT/AF Alerts Wireless device from implant to follow-up Daily remote monitoring with Mobile DirectAlerts notifications to enable timely response

6 References 1. Wolf PA, Dawber TR, Thomas HE Jr, Kannel WB. Epidemiologic assessment of chronic atrial fibrillation and risk of stroke: the Framingham Study. Neurology 1978; 28(10): Wolf PA. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991;22(8): Friberg L, et al. Stroke in paroxysmal atrial fibrillation: report from the Stockholm Cohort of Atrial Fibrillation. Eur Heart J Apr;31(8): Healey JS, ASSERT Investigators, et al. Subclinical Atrial Fibrillation and the Risk of Stroke. New England Journal of Medicien Jan 12; 366: EHRA, ECAS, ACC, AHA, STS, Calkins H, et al. HRS/EHRA/ECAS expert Consensus Statement on catheter and surgical ablation of atrial fibrillation: recommendations for personnel, policy, procedures and follow-up. A report of the Heart Rhythm Society (HRS) Task Force on catheter and surgical ablation of atrial fibrillation. Heart Rhythm Jun;4(6): Crossley GH, CONNECT Investigators, et al. The CONNECT (Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision) trial: the value of wireless remote monitoring with automatic clinician alerts. J Am Coll Cardiol Mar 8;57(10): Varma N, TRUST Investigators, et al.efficacy and safety of automatic remote monitoring for implantable cardioverter-defibrillator follow-up: the Lumos-T Safely Reduces Routine Office Device Follow-up (TRUST) trial. Circulation Jul 27;122(4): Saxon LA, et al. Long-term outcome after ICD and CRT implantation and influence of remote device follow-up: the ALTITUDE survival study. Circulation Dec 7;122(23): Task force for the management of atrial fibrillation of the European Society of Cardiology. Guidelines for the management of atrial fibrillation. European Heart Journal. 2010;31: Hart RG, et al.meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med Jun 19;146(12):

7 St. Jude Medical is focused on reducing risk by continuously finding ways to put more control into the hands of those who save and enhance lives. ATRIAL FIBRILLATION CARDIAC RHYTHM MANAGEMENT CARDIOVASCULAR NEUROMODULATION Global Headquarters One St. Jude Medical Drive St. Paul, Minnesota USA Fax Cardiac Rhythm Management Division Valley View Court Sylmar, California USA Fax St. Jude Medical Sweden AB Veddestavägen 19 SE Järfälla Sweden Fax St. Jude Medical Coordination Center BVBA The Corporate Village Avenue Da Vincilaan 11 Box F1 B-1935 Zaventem, Belgium Fax St. Jude Medical Brasil Ltda. Rua Frei Caneca, º ao 9º andares São Paulo (SP) Brazil Fax St. Jude Medical (Hong Kong) Ltd. Suite 1608, 16/F Exchange Tower 33 Wang Chiu Road Kowloon Bay, Kowloon Hong Kong SAR Fax St. Jude Medical Japan Co., Ltd. Shiodome City Center 15F 1-5-2, Higashi-Shinbashi, Minato-ku, Tokyo , Japan Fax SJMprofessional.com/clinical 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. Devices depicted may not be available in all countries. Check with your St. Jude Medical representative for product availability in your country. Unless otherwise noted, and indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are trademarks and service marks of St. Jude Medical, Inc. and its related companies St. Jude Medical, Inc. All Rights Reserved. Item P-00179