dr. wilson
TRANSCRIPT
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David Wilson, MD• Electrophysiologist at the
CardioVascular Group/Gwinnett Medical Group
• Board Certified in Internal Medicine, CardiovascularDiseases, and Electrophysiology
• Special interests include
electrophysiology, pacemakers, and RF ablations
Fellowship: Harbor-UCLA
Medical Center
Residency:Harbor-UCLA Medical
Center
Medical School:Indiana University
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David A. Wilson, M.D.
EARLY AF DETECTION & STROKE PREVENTION UTILIZING AUTOMATIC DAILY
DEVICE MONITORING.
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STROKES ATTRIBUTABLE TO AF - FRAMINGHAM
50-59 60-69 70-79 80-890
5
10
15
20
25
AF prevalenceEvents attributable to AFColumn1
Wolf et al. Stroke 1991;22:983-988.
Age
%
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Hart RG et al. Ann Intern Med. 2007;146:857-867.
Study Year
AFASAK I 1989; 1990
SPAF I 1991
BAATAF 1990
CAFA 1991
SPINAF 1992
EAFT 1993
All trials (n=6)N=2,900
Relative Risk Reduction(95% CI)
Favors Warfarin Favors Placeboor Control
100% 50% 0 -50% -100%
Adjusted-dose warfarin comparedwith placebo or control
EFFICACY OF WARFARIN(COMPARED WITH PLACEBO OR CONTROL IN SIX STUDIES)
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CASE STUDY• 64 year old male
• History of hypertension, type 2 DM
• Symptomatic bradycardia 2/2013 with subsequent pacemaker implantation 2/10/2013
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ROUTINE OFFICE FOLLOW-UP• Feels well with no palpitations, active.
• Current medications metformin, lisinopril and atorvastatin and aspirin.
• BP 125/75, paced at 60 bpm.
• Pacemaker check shows normal function.
• Atrial high rate activity lasting 2 hours 11 months ago. Multiple brief episodes lasting <10 minutes
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HOW WOULD YOU MANAGE THE PATIENT?A. Start amiodarone and follow for recurrent AF
B. Start aspirin and clopidogrel
C. Start NOAC or warfarin
D. Intensify monitoring
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RISK ASSESSMENT
Fridberg, Eur Heart J 2012; 33:1500
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TRENDS STUDY• Prospective observational study in CRM implanted patients
• Defined AF burden as longest 1 day duration in past 30 days
• Compared stroke risk in patients who in prior 30 days had:
• no AF vs AF< 5.5 hrs max/day to AF > 5.5 hrs on any of prior 30 days
• Alternative comparison is total duration AF prior 30 days with 10.8 hours cut point
Circulation: Arrhythmia and Electrophysiology 2009; 2: 474
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TRENDSMETHODOLOGY
Circulation: Arrhythmia and Electrophysiology 2009; 2: 474
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• 2486 patients from 116 centers, means age 71, mean CHADS2 2.2
• 53% of patients had no AF
• p 0.06 for High AF vs zero AF
TRENDS - Results TRENDS - Results
Circulation: Arrhythmia and Electrophysiology 2009; 2: 474
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ASKING AGAIN, WHAT WOULD YOU RECOMMEND?• Start amiodarone and follow for recurrent AF
• Start aspirin and clopidogrel
• Start NOAC or warfarin
• Intensify monitoring
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ASSERTStudy Design
-3 0 3 9 15 21 27 33 39 45 51 57
Months
Enrolled 0-8 wks
post implant
Mininum Follow up 1.75 yrsMaxmum Follow Up 5 yrsMean Follow Up 2.8 yrs
ArrhythmiaDetection
Follow Up Period
Primary Outcome: Ischemic Stroke or Systemic Embolism
Visits
Prospective Cohort DesignTo determine if device-detected atrial tachyarrhythmias are associated with anincreased risk of stroke or embolism?
Asymptomatic Atrial Fibrillation and Stroke Evaluation in Pacemaker Patients and the Atrial Fibrillation Reduction Atrial Pacing Trial
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ASSERT: STUDY RESULTS
• 2580 patients enrolled following implant of first pacemaker or ICD (St. Jude Medical)• 2451 pacemaker, 129 ICD patients
• 136 participating centres, 23 countries
• Mean follow up 2.8 yrs
• 36% of patients had at least one device-detected atrial tachyarrhythmia• >6 min, >190 bpm; at mean FU of 2.8 years
• Cumulative rate of VKA use <2% per year
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TIME TO FIRST DEVICE-DETECTED ATRIAL TACHYARRHYTHMIA > 6 MIN, >190 BPM
Years of Follow-up
Cum
ulat
ive H
azar
d Ra
tes
0.0
0.1
0.2
0.3
0.4
0.5
0.6
0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0
# at Risk Year 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.02580 2059 1842 1663 1371 1008 706 446 243
ASSERT : Time to Adjudicated AHRE(>6 minutes,>190/minute)
3 month Visit
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BASELINE CHARACTERISTICSDevice-Detected Atrial Tachyarrhythmia before
3 Month Visit P-Value
NoN = 2319
YesN = 261
Age (years) (mean ± SD) 76.3 ± 6.7 77.0 ± 6.8 0.13
Male 58.7% 54.9% 0.27
History of Prior Stroke 7.2% 6.9% 0.84
History of Heart Failure 14.4% 14.9% 0.83
History of Diabetes Mellitus 29.1% 22.6% 0.03
History of Myocardial Infarction 18.4% 12.3% 0.01
CHADS2 score (mean ± SD) 2.26 ± 1.02 2.21 ± 1.11 0.47
Sinus Node Disease 42% 50% 0.01
Heart Rate 70.0 ± 11.6 67.7 ± 11.7 0.001
Systolic BP (mm Hg) 136.5 ± 20 137.2 ± 20 0.60
Baseline use of ASA 61.7% 61.3% 0.91
Baseline use of Clopidogrel 10.7% 9.6% 0.56
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ASSERT: ISCHEMIC STROKE OR SYSTEMIC EMBOLISM
Years of Follow-up
Cum
ulat
ive H
azar
d Ra
tes
0.0
0.02
0.04
0.06
0.08
0.10
0 0.5 1.0 1.5 2.0 2.5
# at Risk Year 0.5 1.0 1.5 2.0 2.5+_ 261 249 238 218 178 122
2319 2145 2070 1922 1556 1197
RR=2.4995%CI 1.28-4.85P=0.007 Device-Detected Atrial Tachyarrhythmia
Detected 0-3 months
No Asymptomatic Atrial Tachycardia Detected 0-3 months
T0 at 3-month visit
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PRIMARY AND OTHER CLINICAL OUTCOMES
Event
Device-Detected Atrial Tachyarrhythmia Device-Detected Atrial
Tachyarrhythmia Present vs. absentAbsent
N=2319PresentN= 261
events %/year events %/ year RR 95% CI p
Ischemic Stroke or Systemic Embolism 40 0.69 11 1.69 2.49 1.28 – 4.85 0.007
Vascular Death 153 2.62 19 2.92 1.11 0.69 – 1.79 0.67
Stroke / MI / Vascular Death 206 3.53 29 4.45 1.25 0.85 – 1.84 0.27
Clinical Atrial Fibrillation or Flutter 71 1.22 41 6.29 5.56 3.78 – 8.17 <0.001
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CLINICAL OUTCOMES BY CHADS2
CHADS2
ScoreTotal Pts.
Sub-clinical Atrial Tachyarrhythmia between enrollment and 3 months Sub-clinical Atrial
TachyarrhythmiaPresent vs. absentPresent Absent
Pts. events %/year Pts. event
s %/year HR 95% CIP
(trend)
1 600 68 1 0.56 532 4 0.28 2.11 0.23 – 18.9
0.352 1129 119 4 1.29 1010 22 0.77 1.83 0.62 – 5.40
>2 848 72 6 3.78 776 18 0.97 3.93 1.55 – 9.95
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ASSERT - DURATION OF EPISODES
Duration of AT >190 bpmQuartile analysis
Ischemic stroke or TEAT present vs absentRR 95% CI
6 min – 0.86 hour 1.23 0.15-4.46
0.87 – 3.63 hours 0 0-2.08
3.64 – 17.72 hours 1.18 0.14-4.28
> 17.72 hours 4.89 1.96-10.07
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TRENDS COMPARED TO ASSERT• Similar events 51/2486 in TRENDS vs 59/2580 ASSERT
• Similar CHADS2 score, 2.2 both trials
• Older age in ASSERT (76 vs 71)
• Fewer males in ASSERT (58% vs 66%)
• More AF in TRENDS than ASSERT (47% vs 36%)
• TRENDS did not exclude prior clinical AF patients with 20% prior history
• 21% on warfarin at entry
• Both studies had relatively low event rates
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ASSERT: RELATIONSHIP BETWEEN AHRE AND STROKE
• In ASSERT, 59 patients had stroke or SE
• 30 had no AHRE
• 9 had AHRE but only AFTER their stroke
• 20 patients had at least one AHRE > 6 minutes prior to their stroke or SE
• 3 developed persistent AF at least one month before, but only recognized clinically in 1 pt.
• 2 patients had 9-day long episodes 1-2 weeks prior
• 1 patient had 2.7 hour episode beginning 48 hours prior
• None of remaining 14 pts. had ANY AHRE > 6 minutes in 30 days before stroke or SE
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Michela Brambatti et al. Circulation. 2014;129:2094-2099Copyright © American Heart Association, Inc. All rights reserved.
SUMMARY OF SUBCLINICAL ATRIAL FIBRILLATION (SCAF) OCCURRING WITHIN 1 YEAR OF STROKE OR SYSTEMIC EMBOLISM.
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TRENDS COMPARED TO ASSERT• Similar events 51/2486 in TRENDS vs 59/2580 ASSERT
• Similar CHADS2 score, 2.2 both trials
• Older age in ASSERT (76 vs 71)
• Fewer males in ASSERT (58% vs 66%)
• More AF in TRENDS than ASSERT (47% vs 36%)
• TRENDS did not exclude prior clinical AF patients with 20% prior history
• 21% on warfarin at entry
• Both studies had relatively low event rates
• TRENDS followed event windows, not patients
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STROKE SEVERITY IN ASSERT
Healey, HRS 2015
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WHAT IS THE CAUSE OF STROKE IN AF• Virchow stated 3 potential contributors
1. Abnormalities in blood flow
2. Abnormalities in the blood vessel wall
3. Interaction with blood constituents
• Atrial dilation, scarring and reduced contractility 1, 2
• CHF and mitral stenosis 1
• Spontaneous echo contrast 1
• Hypercoagulable state: increased platelet activation, thrombogenesis, endotheliial dyfunction 2, 3
• Atrial remodeling: AF begets AF
• Hypertension, DM, Age contribute to abnormal blood flow, atrial dilation, scarring and/or endothelial dysfunction
• Some of the abnormalities promoting AF may independently increase stroke risk without AF, so SCAF can serve as a risk marker
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CLINICAL OUTCOMES BY CHADS2
CHADS2
ScoreTotal Pts.
Sub-clinical Atrial Tachyarrhythmia between enrollment and 3 months Sub-clinical Atrial
TachyarrhythmiaPresent vs. absentPresent Absent
Pts. events %/year Pts. event
s %/year HR 95% CIP
(trend)
1 600 68 1 0.56 532 4 0.28 2.11 0.23 – 18.9
0.352 1129 119 4 1.29 1010 22 0.77 1.83 0.62 – 5.40
>2 848 72 6 3.78 776 18 0.97 3.93 1.55 – 9.95
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CLINICAL OUTCOMES BY CHADS2
CHADS2
ScoreTotal Pts.
Sub-clinical Atrial Tachyarrhythmia between enrollment and 3 months Sub-clinical Atrial
TachyarrhythmiaPresent vs. absentPresent Absent
Pts. events %/year Pts. event
s %/year HR 95% CIP
(trend)
1 600 68 1 0.56 532 4 0.28 2.11 0.23 – 18.9
0.352 1129 119 4 1.29 1010 22 0.77 1.83 0.62 – 5.40
>2 848 72 6 3.78 776 18 0.97 3.93 1.55 – 9.95
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ARTESIAAPIXABAN FOR THE REDUCTION OF THROMBO-EMBOLISM DUE TO SUB-CLINICAL ATRIAL FIBRILLATION• Double blind RCT of Apixaban vs ASA
• Patients with at least one episode EHRA 6 min-24 hr duration
• CHA2DS2-VASc >= 4
• Primary outcome of stroke/STE
• Expected enrollment 3917 to show 35% RR reduction
• Start 5/2015, expected completion 7/2019
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IMPACT
Healey, HRS 2015
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IMPACT RESULTS
Healey, HRS 2015
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REACT COMRHYTHM EVALUATION FOR ANTICOAGULATION WITH CONTINUOUS MONITORING
• Documented PAF, either clinical or subclinical with Reveal monitor implantation
• CHADS2 score 1-2
• Pilot study for safety completed 2/2015
• Plan to randomize to strategy of NOAC administration continuously vs at time of detection plus 30 days
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INCREASED PATIENT ACCESS
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SO WHAT’S THE FINAL VERDICT?• 2 hour AHRE 11 months prior plus brief blips, CHA2DS2-VASc 2/ CHADS2 2
• Start amiodarone and follow for recurrent AF
• Start aspirin and clopidogrel
• Start NOAC or warfarin
• Intensify monitoring while awaiting trial data
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ANY QUESTIONS?
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VIDEO BY DR. SHARMA AND DR. WILSON