syncope risk stratification systems: current limitations, future … › occ2016ppt › 0068.pdf ·...
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Syncope Risk Stratification Systems:Current Limitations, Future Prospects
David G Benditt MD FACCUniversity of Minnesota Medical School
Arrhythmia and Syncope CenterMinneapolis, Minnesota
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Relevant Conflicts of Interest
None
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Syncope & Collapse:Not all Collapse is Syncope
Careful History and Evaluation is Needed
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The Problem
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• Syncope and Collapse are Costly• 〰740,000 ED Visits in US /year• 〰 250,000 Hospital Admissions
• $US 2.4 Billion in Hospital Costs • 〰 Approx 30% hospital admission rate• Triggered by concern for adverse outcomes
• Hospital evaluations • Expensive• Low diagnostic and treatment yields
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Risk Stratification Determines Need For:
• Immediate hospitalization vs outpatient assessment based on:• Likelihood of cardiac syncope• Injury or potential injury risk• Ability to care for self
• Early intensive evaluation• Outpatient monitoring vs invasive study (e.g., EPS)
• Nature of subsequent management • Referral to other specialty (e.g., neurology, psychiatry)
Effective Risk Stratification Schemes Should:• Diminish Number of Hospitalizations• Enhance Evaluation Efficiency and • Reduce Costs
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Current Risk Stratification Schemes:Short-term
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Current Risk Stratification Schemes: Longer-term
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Predictors of Mortality in EGSYS2Ungar et al, Eur Heart J 2010
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Derivation Cohort Validation Cohort
Mo
rtal
ity
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Risk Stratification
• Currently best for addressing near-term risks (1 wk to 1 mo) • Death, injury, • Syncope recurrence, • Early Return to ED or Hospitalization
• Less successful for longer-term adverse events• Often unclear if syncope increases risk of underlying
disease• Impact on QoL & independent lifestyle unclear
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Multiple Risk Stratification Schemes
• Many Proposals: None are Optimal • Differing Risk Identifiers in Various Reports: Only ECG is Common• End-points Vary: Mortality, Injury, Re-Hospitalization• Small Sample Sizes, Often Single Center• Largely Caucasian population, Not Multicultural• Validation Studies Not Standard
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Risk Stratification: Limitations
ACC/AHA/HRS 2016
Standardized Definitions and Data ReportingCurrently even definition of ‘syncope’ varies
ESC 2009
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Necessary Adaptations of Current Risk Stratification Schemes:
Classify Risk by Patient Subsets
• Standard definitions• ‘Healthy’ fainters vs structural disease• Collapse in the elderly vs younger patients• Short-term (ED) vs Long-term Outcomes• Accommodate expanding literature• Syncope may not increase mortality risk
in some diseases• But may increase injury and cost of care
risk
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Corrado et al Circ 2003
Syncope as Risk Factor in ARVC Comparable to other risks
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Risk factors-massive
hypertrophy
-SCD hx
-NSVT
-SUO
HCM: Risk Factors for Appropriate ICD Shock
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Syncope in Hypertrophic CMSpirito et al Circulation 2009
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Syncope During Beta-Blocker in LQTS:
17Jons et al JACC 2010
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Syncope Risk Stratification Goals for the Future
• Multicenter / Multicultural trials• Larger numbers of patients• Sub-group assessment (e.g., SHD vs no-SHD)
• Risk marker identification• Development group• Validation test group
• SMU availability may diminish hospitalization need• ‘Big’ Data
• Leverage centrally collected data from implanted and/or wearable diagnostic devices to develop better understanding of risk factors
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Factors That Enhance Risk Marker Identification
• Practice guideline recommendations• Greater awareness of need
• Specialized practices• Syncope management units (SMUs)
• Enhanced patient monitoring to define diagnoses• Remote monitoring• Development of ECG/Hemodynamic monitors
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Advanced Outpatient Diagnostics:May Improve Accuracy and Reduce Cost
Incorrect Diagnoses are Costly and Potentially Hazardous
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Future of Risk Stratification:
• Standardized definitions• Syncope vs TLOC
• Time frames (days/weeks vs years)
• Standard risk category reporting• Death
• Injury
• etc
• Clarify patient risk subsets instudies• ‘Healthy’ vs SHD
• Disease dependent risk
• Multicenter studies• Large samples
• Uniform follow-up
• Validation studies
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Current Risk Stratification Limitations
• Which ‘risk’ is the end-point of interest:• Mortality• Injury• Repeat hospitalization• Loss of independence, occupation
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Syncope Management Units (SMUs)
• Facilitate uniform data collection• Increasingly widespread• Models vary with health care system design /
Practitioner preference• ED based (SEEDS)• Outpatient clinic• In-hospital Units• Mixed
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Structured Care with SMUs:Current Approach is Inefficient
• Currently approx 35% of Syncope/Collapse are hospitalized• Probably about ½ that number is appropriate
• Hospital diagnostic evaluation is generally ineffective and inefficient
• Syncope Management Units (SMUs) may improve diagnostic capability at lesser cost
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Implantable Cardiac Monitors (Insertable and Wearable Loop Recorders
ILRs/WLRs• Invaluable for arrhythmia diagnosis
• Limitations• : Unable to determine hemodynamic impact of detected
arrhythmias, or
• confirm hypotension in symptomatic patients
• Addition of hemodynamic monitors• Could offer more comprehensive assessment of
arrhythmias in free-living subjects
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ILR-detected Unexplained Syncope:About 1/3 are in sinus rhythm –other diagnostic tools are needed
Asyst Brady Normal SR Tachy Total
Pilot study
Circulation, 95
? 7(47%) 6(40%) 2(13%) 15/16 94%
Krahn et al
Circulation, 99
? 14(69%) 7(30%) 2 (9%) 23/85 27%
Nierop et al
PACE, 2000
? 4(29%) 6(43%) 4(29%) 14/35 40%
ISSUE study 16(50%) 3(9%) 12(34%) 1 (3%) 32/111
29%
Total 44
52%
31
37%
9
11%
84/247 34%
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Future ILR/WLR Monitoring
• Remote interrogation• Wireless mobile interrogation, 24/7 monitoring• Voice-activated for symptom reporting• GPS to facilitate summoning assistance
• Novel sensors• Assess hemodynamic impact of rhythm disturbances • Evaluate clinical posture / activitywhen events occur
• New Applications• ‘Seizure’ evaluation• Heart failure monitoring
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Advanced Diagnostics for Ambulatory Patients:
Distinguishing Faints from Falls
•ECG•BP/Flow•EEG•Position•Blood sugar
Combo Device
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The Future
“The future, according to some scientists, will be exactly like the past
…only far more expensive”John Sladek (1937-2000)
Science Fiction AuthorDied Minneapolis, MN
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Summary• Guidelines from ESC and ACC/AHA/HRS provide direction
• Need multidisciplinary acceptance
• Risk Stratification and SMU concepts seem appropriste steps• Current evidence is positive but studies are small
• Supportive multicenter studies needed
• Thoughtful study design / end-points
• Advanced monitoring technology may• Speed diagnosis
• Differentiate falls from faints (possibly from seizures)
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Identifying Patients with
Cardiac Causes of Syncope is a
Primary Risk Stratification
Goal:• Increasing Age
• Co-morbidities
• CV Drugs
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Syncope as Risk Factor in HCMSpirito 2009
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Miniaturized ICM Device
87% smaller and
wireless transmissions
3-year monitoring
remote management
38
Medtronic Confidential. Internal Use Only.
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How Do Specific Diseases Impact
Mortality/SCD Risk?
• Varies by diagnosis
• Many uncertainties remain- Most reports examine mortality not SCD
- Evolving knowledge base
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Steinberg et al JCE 2001
Mortality & Arrhythmia in AVID
Syncope Substudy
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Syncope in SCD Heft:Associated with Increased Mortality
Trends…but not SCDOlshansky et al JACC 2008
Not Prevented by ICD
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Eur Heart J Supp 1989
More recent multicenter ARVC study in press plays down Syncope as risk factor
unless associated with VT or NSVTMarcus et al JACC EP (in press)
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SMU Potential Economic BenefitsEGSYS 2 , Eur Heart J 2006