Expanded Indications for Implantable Loop Recorders. Disclosures:

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1 Expanded Indications for Implantable Loop Recorders Spoleto Cardiology Update 2015 J. Lacy Sturdivant M.D. Asst. Prof. of Cardiovascular Disease Cardiac Electrophysiology Medical University of South Carolina May 27, 2015 Boston Scientific Medtronic St Jude Medical Disclosures: 1

2 Objectives: Identify indications for Implantable Cardiac Monitors(ICM) The connection between stroke and atrial fibrillation CRYSTAL-AF study results Clinical effectiveness of long-term monitoring Identify patients at high risk for recurrent stroke, eligible for anticoagulation Indications for Monitoring Syncope Palpitations Heart Rate Control with Atrial Fibrillation Chronotropic Incompetence Intermittent Chest Pain Post Ablation Monitoring Cryptogenic Stroke 2

3 Palpitations Frequently difficult to diagnose and correlate with symptoms Significant patient anxiety associated with cardiac palpitations Frequency of symptoms may render traditional ambulatory monitoring useless Extrinsic noise renders tracings useless Fidelity of recordings makes precise diagnosis challenging Only two or three ECG leads are available for review ~40% of the population will have at least one syncopal event in their lifetime 10% of falls by elderly are believed due to syncope Major morbidity reported in 6% (e.g. fractures, motor vehicle accidents) Minor injury reported in 29% (e.g. lacerations, bruises) Syncope Facts 1 Kenny RA, et al. eds. The Evaluation and Treatment of v. Futura; 2003: Kapoor W. Medicine. 1990;69: *Syncope and collapse (ICD-9 Code: 780.2) listed as primary reason for visit. NAMCS

4 Syncope Etiology Syncope remains unexplained in approximately 1/3 of cases Unknown Neurally mediatedvasovagal, carotid sinus, situational Cardiac Neurologicseizure, stroke, TIA, etc Orthostatic/Drug- Induced Cryptogenic Stroke Why Atrial Fibrillation(AF) Matters 25% of ischemic strokes are considered crytogenic, despite intense work-up 1 Patients may have underlying, undiagnosed AF Detection of AF in these patients changes treatment Guidelines state change from antiplatelet therapy to OAC 2 1 Adams HP Jr, Stroke. Jan 1993; 24; 35-41; 2 Camm et al, European Heart Journal. 2012; 33,

5 Stroke Etiologies The Challenge of Cryptogenic Stroke Vessel Rupture (15%) Arterial Occlusion (85%) Atherothrombotic (25-30%) stenotic artery feeding area of infarction Cardioembolic (20%) thrombus or other material dislodges from the heart or aortic arch Lacunar/Small Vessel (15-20%) small, deep infarct Other/Uncommon (5-10%) Crytogenic (25-30%) Adams HP Jr, Bendixen BH, Kappelle LJ, et al. Classification of subtype of acute ischemic stroke. Definitions for use in a multicenter clinical trial. TOAST. Stoke. January 1993 Why Continuous AF Monitoring is Important AF may be asymptomatic AF may be intermittent AF duration may be important Even intermittent AF of short duration can lead to stroke and heart failure 5

6 N=48 1 Why Not Just Trust the Patient s Symptoms? 95% of AT episodes were asymptomatic AF symptoms accurate only 15% of time 45% of patients reported symptoms without recorded AT event Other studies 2 show 12:1 ratio asymptomatic:symptomatic AT 1 Strickberger A. et al. Relationship between atrial tachyarrhythmias and symptoms. Heart Rhythm. 2005;2: Page RL, Wilkinson WE, Clair WK, et al. Asymptomatic arrhythmias in patients with symptomatic paroxysmal atrial fibrillation and paroxysmal supraventricular tachycardia. Circulation. 1994;89: TRENDS Study Subgroup Analysis Newly Detected AF ( NDAF ) in Stroke Patients Methods: N = 163 Previous ischemic stroke/ TIA with no known AF Continuous monitoring via pacemaker or ICD Results: NDAF > 5 minute duration were found in 28% patients 73% with newly detected AT/AF on <10% of follow-up days Freedom from AT/AF % of NDAF patients identified beyond 1 day 78% of NDAF patients identified beyond 7 days 60% of NDAF patients identified beyond 30 days Number 3 mo. 6 mo. 9 mo. 12 mo. at Risk: Time from Device Implant (months) Value of Long Term, Continuous Monitoring Detect intermittent AF Ziegler P. et al. Stroke. 2010;41 6

7 Atrial Fibrillation Limitations of Intermittent, External Monitoring N = 574 pacemaker patients All known to have AF 12 month retrospective analysis Intermittent monitoring simulated with randomly selected days Intermittent and symptombased monitoring is highly inaccurate for identifying patients with any or longduration AT/AF and for assessing AT/AF burden. Ziegler P. Comparison of continuous versus intermittent monitoring of atrial arrhythmias. Heart Rhythm. 2006;3: ). Incidence of AF Detected by ICM in Cryptogenic Stroke Methods: N=51 Workup: Vascular/cardiac imaging, >24 hrs cardiac monitoring Results: AF identified in 13(25.5%) of patients Median time to AF detection: 48 days 6 min median duration of first AF episode Cotter et al, Neurology. 2013;80(14). 7

8 Occult Atrial Fibrillation in Cryptogenic Stroke Detection 7-Day ECG vs. ICM Methods: N = 60 cryptogenic stroke patients ICM vs 7-day Holter monitor Patient workup: Cerebral imaging, ECG, 72 hour telemetry, 24-hour Holter, TEE Min 12 month follow-up Results: AF detected in 10 pts (17%) vs. 7-day ECG (1.7%) 64 days avg time to detection post-stroke Time to First Episode of AF Most patients diagnosed with AF within 90 days post insertion Ritter et al, Stroke. 2013; Volume 44, Issue 5. Atrial Fibrillation: Symptoms and Stroke 90% of AF episodes are asymptomatic 1 Even in patients with symptoms, ratio of asymptomatic to symptomatic is 12:1 2 25% of those with AF-associated stroke have no known prior history of AF 3 Even in stroke patients with known PAF, 50-70% are in sinus rhythm at the time of the stroke 4 1. Strickberger et al. Heart Rhythm. 2005;2: Rho R: Prog CV Disease: 2005:48;79 3. Jabaudon D, Stroke:2004: 35: Falk R: NEJM 2002; 347:

9 CRYSTAL AF Study: CRYptogenic Stroke And underlying Atrial Fibrillation Objectives: Assess ICM vs. Standard Care for detection of AF in cryptogenic stroke patients 6 month endpoint (primary) 12 month endpoint (secondary) Determine proportion of patients with underlying AF Record actions taken after AF diagnosis Sanna T, Diener HC, Passman RS, et al. Cryptogenic Stroke and Underlying Atrial Fibrillation (CRYSTAL AF). N Engl J Med. 2014; 370(26): CRYSTAL AF Study Overview Patient had to have Cryptogenic stroke/tia Randomized to SoC or ICM AF defined as >=30 seconds Primary endpoint AF detection at 6 months Secondary endpoints AF detection at 12 months AF duration Symptom correlation Physician actions 9

10 Crystal AF study Patient Inclusion Criteria: >= 40 years of age Cryptogenic stroke/tia, with infarct seen on MRI or CT, within 90 days, no mechanism (including AF) after: 12 lead ECG 24 hour ECG monitoring (e.g. Holter) Transesophageal echocardiography (TEE) CTA or MRA of head and neck to rule out arterial source Screening for hypercoagulable states in patients <55 years old Patient Exclusion Criteria: History of AF or Atrial Flutter Permanent indication or contraindication for anticoagulation Indication for pacemaker or ICD Crystal AF -At 36 months, 30% of patients in the ICM arm found to have AF -8.8x more patients than in the standard follow-up arm Sanna T, Diener HC, Passman RS, et al. Cryptogenic Stroke and Underlying Atrial Fibrillation (CRYSTAL AF). N Engl J Med. 2014; 370(26):

11 Crystal AF: Study Design Crystal AF: Results 11

12 Crystal AF Stroke Algorithm 12

13 Conclusions ICM s are a minimally invasive options for long term monitoring in patients with syncope, undiagnosed palpitations, or cryptogenic stroke Amount of actionable intelligence provided is high and quality of electrograms is excellent ICM s change management for a large portion in who they are implanted ICM s are clearly indicated in cryptogenic stroke patients 13

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