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Syncope A Diagnostic and Treatment Strategy

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Title: Syncope A Diagnostic and Treatment Strategy


1
Syncope A Diagnostic and Treatment Strategy
David G. Benditt, M.D. University of Minnesota
Medical School Minneapolis, MN USA
Richard Sutton, DScMed Royal Brompton Hospital
London, UK
2
Transient Loss of Consciousness (TLOC)
3
Classification of Transient Loss of Consciousness
(TLOC)
Real or Apparent TLOC
  • Syncope
  • Neurally-mediated reflex syndromes
  • Orthostatic hypotension
  • Cardiac arrhythmias
  • Structural cardiovascular disease
  • Disorders Mimicking Syncope
  • With loss of consciousness, i.e., seizure
    disorders, concussion
  • Without loss of consciousness, i.e., psychogenic
    pseudo-syncope

Brignole M, et al. Europace, 20046467-537.
4
Syncope A Symptom, Not a Diagnosis
  • Self-limited loss of consciousness and postural
    tone
  • Relatively rapid onset
  • Variable warning symptoms
  • Spontaneous, complete, and usually prompt
    recovery without medical or surgical intervention

Underlying mechanism is transient global
cerebral hypoperfusion.
Brignole M, et al. Europace, 20046467-537.
5
Presentation Overview
  • I. Etiology, Prevalence, Impact
  • II. Diagnosis
  • III. Specific Conditions and Treatment
  • IV. Special Issues

6
Section I Etiology, Prevalence, Impact
7
Causes of True Syncope
Orthostatic
Cardiac Arrhythmia
Structural Cardio- Pulmonary
Neurally- Mediated
  • 3
  • Brady
  • SN Dysfunction
  • AV Block
  • Tachy
  • VT
  • SVT
  • Long QT Syndrome
  • 1
  • VVS
  • CSS
  • Situational
  • Cough
  • Post-
  • Micturition
  • 2
  • Drug-Induced
  • ANS Failure
  • Primary
  • Secondary
  • 4
  • Acute Myocardial Ischemia
  • Aortic Stenosis
  • HCM
  • Pulmonary Hypertension
  • Aortic Dissection

Unexplained Causes Approximately 1/3
DG Benditt, MD. U of M Cardiac Arrhythmia Center
8
Syncope Mimics
  • Acute intoxication (e.g., alcohol)
  • Seizures
  • Sleep disorders
  • Somatization disorder (psychogenic
    pseudo-syncope)
  • Trauma/concussion
  • Hypoglycemia
  • Hyperventilation

Brignole M, et al. Europace, 20046467-537.
9
Impact of Syncope
  • 40 will experience syncope at least once in a
    lifetime1
  • 1-6 of hospital admissions2
  • 1 of emergency room visits per year3,4
  • 10 of falls by elderly are due to syncope5
  • Major morbidity reported in 61 eg, fractures,
    motor vehicle accidents
  • Minor injury in 291 eg, lacerations, bruises

1Kenny RA, Kapoor WN. In Benditt D, et al. eds.
The Evaluation and Treatment of Syncope.
Futura200323-27. 2Kapoor W. Medicine.
199069160-175.
3Brignole M, et al. Europace. 20035293-298. 4
Blanc J-J, et al. Eur Heart J.
200223815-820. 5Campbell A, et al. Age and
Ageing. 198110264-270.
10
Impact of Syncope US Trends
Inpatient Trend
Physician Office Visits
(000s)
(000s)
All patients discharged with syncope and
collapse (ICD-9 Code780.2) listed among
diagnoses.
Syncope and collapse (ICD-9 Code 780.2)
listed as primary reason for visit.
NHDS 2003.
NAMCS 2002.
11
Impact of Syncope US Trends
Hospital Outpatient Visits
Emergency Department Visits
(000s)
(000s)

Not available
Syncope and collapse (ICD-9 Code780.2) listed
as primary reason for visit.
NHAMCS 2002.
12
Impact of Syncope NHS Hospitals, England,
2002-2003
  • 74,813 hospital consults for syncope and
    collapse
  • 80 required hospital admission
  • Average length of stay 6.1 days
  • 327,201 hospital bed days, second only to
    senility

Hospital Episode Statistics, Dept. of Health,
Eng. 2002-2003.
13
Impact of Syncope Costs
  • Estimated hospital costs exceeded 10 billion US1
  • Estimated physician office expenses exceeded 470
    million2
  • 104,285 spent on 1,334 patients with syncopal
    codes (UK) (EaSyAS)3
  • Hospital admission 67 of investigational costs
  • Over 7 billion is spent annually in the US
    to treat falls in
    older adults4

1Kenny RA, Kapoor WN. In Benditt D, et al. eds.
The Evaluation and Treatment of Syncope.
Futura200323-27. 2OutPatientView v. 6.0.
Solucient LLC, Evanston IL. 3Farwell D, et al. J
Cardiovasc Electrophysiol. 200213(Supp)S9-S13. 4
Olshansky B. In Grubb B and Olshansky B. eds.
Syncope Mechanisms and Management. Futura.
199815-71.
14
Impact of Syncope Quality of Life
731
712
602
Percent of Patients
372
Anxiety/ Depression
Alter Daily Activities
Restricted Driving
Change Employment
1Linzer M. J Clin Epidemiol. 1991441037. 2Linzer
M. J Gen Int Med. 19949181.
15
Quality of Life UK Population Norms vs. Syncope
Patients
49
43
37
36
26
Prevalence
19
9
4
3
1
Mobility
Usual Activities
Self-Care
Pain/ Discomfort
Anxiety/ Depression
Rose M, et al. J Clin Epidemiol.
2000531209-1216.
16
Syncope Mortality
  • Low mortality vs. high mortality
  • Neurally-mediated syncope vs. syncope with a
    cardiac cause

Soteriades ES, Evans JC, Larson MG, et al.
Incidence and prognosis of syncope. N Engl J
Med. 2002347(12)878-885. Framingham Study
Population
17
Implications of Syncope for Driving a Vehicle
  • Those who drive and have recurrent syncope risk
    their lives and the lives of others
  • Places considerable burden on the physician
  • Essential to know local laws and physician
    responsibilities
  • Some states Invasion of privacy to notify motor
    vehicle department
  • Other states Reporting is mandatory
  • If the patient has sufficient warning of
    impending syncope Driving may be permitted

Olshansky B, Grubb B. In Syncope Mechanisms and
Management. Futura. Armonk, NY. 1998. Medtronic,
Inc. Follow-up Forum. 1995/961(3)8-10.
18
Challenges of Syncope
  • Diagnosis
  • Complex
  • Quality of life implications
  • Work
  • Mobility (automobiles)
  • Psychological
  • Cost
  • Cost/year
  • Cost/diagnosis

19
Section II Diagnosis
20
Diagnostic Objectives
  • Distinguish true syncope from syncope mimics
  • Determine presence of heart disease
  • Establish the cause of syncope with sufficient
    certainty to
  • Assess prognosis confidently
  • Initiate effective preventive treatment

21
A Diagnostic Plan is Essential
  • Initial Examination
  • Detailed patient history
  • Physical exam
  • ECG
  • Supine and upright blood pressure
  • Monitoring
  • Holter
  • Event
  • Insertable Loop Recorder (ILR)
  • Cardiac Imaging
  • Special Investigations
  • Head-up tilt test
  • Hemodynamics
  • Electrophysiology study

Brignole M, et al. Europace, 20046467-537.
22
Diagnostic Flow Diagram for TLOC
Brignole M, et al. Europace, 20046467-537.
23
Initial Exam Detailed Patient History
  • Circumstances of recent event
  • Eyewitness account of event
  • Symptoms at onset of event
  • Sequelae
  • Medications
  • Circumstances of more remote events
  • Concomitant disease, especially cardiac
  • Pertinent family history
  • Cardiac disease
  • Sudden death
  • Metabolic disorders
  • Past medical history
  • Neurological history
  • Syncope

Brignole M, et al. Europace, 20046467-537.
24
Initial Exam Thorough Physical
  • Vital signs
  • Heart rate
  • Orthostatic blood pressure change
  • Cardiovascular exam Is heart disease present?
  • ECG Long QT, pre-excitation, conduction system
    disease
  • Echo LV function, valve status, HCM
  • Neurological exam
  • Carotid sinus massage
  • Perform under clinically appropriate conditions
    preferably during head-up tilt test
  • Monitor both ECG and BP

Brignole M, et al. Europace, 20046467-537.
25
Carotid Sinus Massage (CSM)
  • Method1
  • Massage, 5-10 seconds
  • Dont occlude
  • Supine and upright posture (on tilt table)
  • Outcome
  • 3 second asystole and/or 50 mmHg fall in
    systolic BP with reproduction of symptoms
    Carotid Sinus Syndrome
  • Absolute contraindications2
  • Carotid bruit, known significant carotid arterial
    disease, previous CVA, MI last 3 months
  • Complications
  • Primarily neurological
  • Less than 0.23
  • Usually transient

1Kenny RA. Heart. 200083564. 2Linzer M. Ann
Intern Med. 1997126989. 3Munro N, et al. J Am
Geriatr Soc. 1994421248-1251.
26
Other Diagnostic Tests
  • Ambulatory ECG
  • Holter monitoring
  • Event recorder
  • Intermittent vs. Loop
  • Insertable Loop Recorder (ILR)
  • Head-Up Tilt (HUT)
  • Includes drug provocation (NTG, isoproterenol)
  • Carotid Sinus Massage (CSM)
  • Adenosine Triphosphate Test (ATP)
  • Electrophysiology Study (EPS)

Brignole M, et al. Europace, 20046467-537.
27
Heart Monitoring Options
OPTION
10 Seconds
12-Lead
2 Days
Holter Monitor
Event Recorders (non-lead and loop)
7-30 Days
Up to 14 Months
ILR
0
1
2
3
4
5
6
7
8
9
10
11
12
13
14
TIME (Months)
Brignole M, et al. Europace, 20046467-537.
28
Diagnostic Assessment Yields (N3411 to 4332)
References Available
29
Neurological Tests Rarely Diagnostic for Syncope
  • EEG, Head CT, Head MRI
  • May help diagnose seizure

Brignole M, et al. Europace. 20046467-537.
30
Head-Up Tilt Test (HUT)
  • Protocols vary
  • Useful as diagnostic adjunct in atypical syncope
    cases
  • Useful in teaching patients to recognize
    prodromal symptoms
  • Not useful in assessing treatment

Brignole M, et al. Europace. 20046467-537.
31
Head-up Tilt Test
Click once on image to play video.
Carlos Morillo, MD, FRCPC Professor, Faculty of
Health Sciences McMaster University, Hamilton
Ontario
32
Head-Up Tilt Test ECG Leads and Intra-Arterial
Pressure Tracing
2
1
DG Benditt, MD. U of M Cardiac Arrhythmia Center
33
Adenosine Triphosphate (ATP) Test
  • Ongoing investigation in the US
  • Provokes a short and potent cardioinhibitory
    vasovagal response
  • Advantages
  • Simple
  • Inexpensive
  • Correlation with pacing benefit
  • Seems to identify a unique mechanism of syncope
    found in patients with
  • Advanced age
  • More hypertension
  • More ECG abnormalities

Brignole M. Heart. 20008324-28. Donateo P.
J Am Coll Cardiol. 20034193-98. Flammang D.
Circ. 1999992427-2433.
34
Insertable Loop Recorder (ILR)
Click once on black screen to play video.
Reveal Plus ILR
Typical Location of the Reveal Plus ILR
35
Insertable Loop Recorder (ILR)
  • The ILR is an implantable patient and
    automatically activated monitoring system that
    records subcutaneous ECG and is indicated for
  • Patients with clinical syndromes or situations at
    increased risk of cardiac arrhythmias
  • Patients who experience transient symptoms that
    may suggest a cardiac arrhythmia

36
Insertable Loop Recorder (ILR)
Click once on black screen to play video.
37
Symptom-Rhythm Correlation with the ILR
CASE 56 year-old woman with refractory syncope
accompanied with seizures.
CASE 65 year-old man with syncope accompanied by
brief retrograde amnesia.
Medtronic data on file.
38
Randomized Assessment of Syncope Trial (RAST)
  • Results
  • Combining primary strategy with crossover, the
    diagnostic yield is 43 ILR only vs. 20
    conventional only1
  • Cost/diagnosis is 26 less than conventional
    testing2

1Krahn AD, et al. Circ. 200110446-51. 2Krahn
AD, et al. JACC. 200342495-501.
39
Conventional EP Testing in Syncope
  • Greater diagnostic value in older patients or
    those with SHD
  • Less diagnostic value in healthy patients without
    SHD
  • Useful diagnostic observations
  • Inducible monomorphic VT
  • SNRT gt 3000 ms or CSNRT gt 600 ms
  • Inducible SVT with hypotension
  • HV interval 100 ms (especially in absence of
    inducible VT)
  • Pacing induced infra-nodal block

Benditt D. In Topol E, ed. Textbook of
Cardiovascular Medicine. Lippencott20021529-1542
. Lu F, et al. In Benditt D, et al. The
Evaluation and Treatment of Syncope. Futura.
200380-95. Brignole M, et al. Europace.
20046467-537.
40
Diagnostic Limitations of EPS
  • Difficult to correlate spontaneous events and
    laboratory findings
  • Positive findings1
  • Without SHD 6-17
  • With SHD 25-71
  • Less effective in assessing bradyarrhythmias
    than tachyarrhythmias2
  • EPS findings must be consistent with clinical
    history
  • Beware of false positive

1Linzer M, et al. Ann Int Med. 199712776-86. 2Lu
F, et al. In Benditt D, et al. The Evaluation
and Treatment of Syncope. Futura. 200380-95.
41
ISSUE International Study of Syncope of Uncertain
Etiology
  • Multicenter, international, prospective study
  • Analyzed the diagnostic contribution of an ILR in
    three predefined groups of patients
    with syncope of uncertain origin
  • Isolated syncope No SHD, Normal ECG1
  • Negative tilt
  • Positive tilt
  • Patients with heart disease and negative EP test2
  • Patients with bundle branch block and negative EP
    test3

1Moya A. Circulation. 2001 1041261-1267.
2Menozzi C, et al. Circulation.
20021052741-2745. 3Brignole M, et al.
Circulation. 20011042045-2050.
42
ISSUE Patients with Isolated Syncope and
Tilt-Positive Syncope

Moya A. Circulation. 20011041261-1267.
43
ISSUE Isolated Syncope vs. Tilt-Positive Syncope
  • Conclusions
  • Results similar in the two arms, including
    syncope recurrence and ECG correlation
  • Tilt-negative patients had as many bradycardias
    (18) as tilt-positive patients (21)
  • Most frequent finding was asystole secondary to
    progressive sinus bradycardia, suggesting a
    neuro-mediated origin
  • Homogeneous findings from tilt-negative and
    tilt-positive infer low sensitivity of
    tilt-testing

Moya A. Circulation. 20011041261-1267.
44
ISSUE Patients with Heart Disease and a Negative
EP Test
AV block asystole 1 A.Fib asystole 1 Sinus
arrest 1 Sinus tachycardia 1 Rapid A.Fib 2
Sustained VT 1 Parox. A.Fib/AT 1 Post
tachycardia pause 1 No rhythm variations
4 Sinus tachycardia 1
Menozzi C, et al. Circulation.
20021052741-2745.
45
ISSUE Patients with Heart Disease and a Negative
EP Test
  • Conclusions
  • Patients with unexplained syncope, overt heart
    disease, and negative EP study had a favorable
    medium-term outcome
  • Mechanism of syncope was heterogeneous
  • Ventricular tachyarrhythmia was unlikely
  • ILR-guided strategy seems reasonable, with
    specific therapy safely delayed until a definite
    diagnosis is made.

Menozzi C, et al. Circulation.
20021052741-2745.
46
ISSUE Patients with Bundle Branch Block and
Negative EP Test
ILR-Detected Pre-Syncope 2 Pts (4)
ILR-Detected 19
Not Detected 3
AVB 2 (4)
AVB 12 (63) SA 4 (21) Asystole-undefined 1
(5) NSR 1 (5) Sinus tachy 1 (5)
5 of these also had 1 presyncope Drop-out
before primary-end point
Brignole M., ET AL.,Circulation.
20011042045-2050.
47
ISSUE Patients with Bundle Branch Block and
Negative EP Test
  • Conclusion
  • In patients with BBB and negative EP study, most
    syncopal recurrences have a homogeneous
    mechanism that is characterized by prolonged
    asystolic pauses mainly attributable to
    sudden-onset paroxysmal AV block

Brignole M. Circulation. 20011042045-2050.
48
Section III Specific Conditions and Treatment
49
Specific Conditions
  • Cardiac arrhythmia
  • Brady/Tachy
  • Long QT syndrome
  • Torsade de pointes
  • Brugada
  • Drug-induced
  • Structural cardio-pulmonary
  • Neurally-mediated
  • Vasovagal Syncope (VVS)
  • Carotid Sinus Syndrome (CSS)
  • Orthostatic

50
Cardiac Syncope
  • Includes cardiac arrhythmias and SHD
  • Often life-threatening
  • May be warning of critical CV disease
  • Tachy and brady arrhythmias
  • Myocardial ischemia, aortic stenosis, pulmonary
    hypertension, aortic dissection
  • Assess culprit arrhythmia or structural
    abnormality aggressively
  • Initiate treatment promptly

Brignole M, et al. Europace. 20046467-537.
51
…cardiac syncope can be a harbinger of sudden
death.
  • Survival with and without syncope
  • 6-month mortality rate of greater than 10
  • Cardiac syncope doubled the risk of death
  • Includes cardiac arrhythmias and SHD

Soteriades ES, et al. N Engl J Med. 2002347878.
52
Syncope Due to Structural Cardiovascular Disease
Principle Mechanisms
  • Acute MI/Ischemia
  • 2 neural reflex bradycardia Vasodilatation,
    arrhythmias, low output (rare)
  • Hypertrophic cardiomyopathy
  • Limited output during exertion (increased
    obstruction, greater demand), arrhythmias, neural
    reflex
  • Acute aortic dissection
  • Neural reflex mechanism, pericardial tamponade
  • Pulmonary embolus/ pulmonary hypertension
  • Neural reflex, inadequate flow with exertion
  • Valvular abnormalities
  • Aortic stenosis Limited output, neural reflex
    dilation in periphery
  • Mitral stenosis, atrial myxoma Obstruction to
    adequate flow

Brignole M, et al. Europace. 20046467-537.
53
Syncope Due to Cardiac Arrhythmias
  • Bradyarrhythmias
  • Sinus arrest, exit block
  • High grade or acute complete AV block
  • Can be accompanied by vasodilatation (VVS, CSS)
  • Tachyarrhythmias
  • Atrial fibrillation/flutter with rapid
    ventricular rate (eg, pre-excitation syndrome)
  • Paroxysmal SVT or VT
  • Torsade de pointes

Brignole M, et al. Europace. 20046467-537.
54
ILR Recordings
CASE 28 year-old man presents to ER multiple
times after falls resulting in trauma. VT
Ablated and medicated.
CASE 83 year-old woman with syncope due to
bradycardia Pacemaker implanted.
Reveal ILR recordings Medtronic data on file.
55
Cardiac Rhythms During Unexplained Syncope
Composite N133 to 7109
Bradycardia 16 (11-21)
No Recurrence 36 (31-48)
Arrhythmia 22 (13-32)
Tachycardia 6 (2-11)
Other 11
Normal Sinus Rhythm 31 (17-44)
Seidl K. Europace. 20002(3)256-262. Krahn AD.
PACE. 20022537-41. Medtronic ILR Replacement
Data. FY03, 04. On file.
56
Long QT Syndromes
  • Mechanism
  • Abnormalities of sodium and/or potassium channels
  • Susceptibility to polymorphic VT (Torsade de
    pointes)
  • Prevalence
  • Drug-induced forms Common
  • Genetic forms Relatively rare, but increasingly
    being recognized
  • Concealed forms
  • May be common
  • Provide basis for drug-induced torsade

Schwartz P, Priori S. In Zipes D and Jalife J,
eds. Cardiac Electrophysiology.
Saunders2004651-659.
57
Syncope Torsade de Pointes
From the files of DG Benditt, MD. U of M Cardiac
Arrhythmia Center
58
Long QT Syndromes 12-Lead ECG
From the files of DG Benditt, MD. U of M Cardiac
Arrhythmia Center
59
Drug-Induced QT Prolongation (List is
continuously being updated)
  • Antiarrhythmics
  • Class IA ...Quinidine, Procainamide, Disopyramide
  • Class III…Sotalol, Ibutilide, Dofetilide,
    Amiodarone, NAPA
  • Antianginal Agents
  • Bepridil
  • Psychoactive Agents
  • Phenothiazines, Amitriptyline, Imipramine,
    Ziprasidone
  • Antibiotics
  • Erythromycin, Pentamidine, Fluconazole,
    Ciprofloxacin and its relatives
  • Nonsedating antihistamines
  • Terfenadine, Astemizole
  • Others
  • Cisapride, Droperidol, Haloperidol

Removed from U.S. Market
Brignole M, et al. Europace, 20046467-537.
60
Treatment of Long QT
  • Suspicion and recognition are critical
  • Emergency treatment
  • Intravenous magnesium
  • Pacing to overcome bradycardia or pauses
  • Isoproterenol to increase heart rate and shorten
    repolarization
  • ICD if prior SCA or strong family history
  • If drug induced
  • Reverse bradycardia
  • Withdraw drug
  • Avoid ALL long-QT provoking agents
  • If genetic
  • Avoid ALL long-QT provoking agents
  • For more information visit www.longqt.org

Schwartz P, Priori S. In Zipes D and Jalife J,
eds. Cardiac Electrophysiology.
Saunders2004651-659.
61
Treatment of Syncope Due to Bradyarrhythmia
  • Class I indication for pacing using dual chamber
    system wherever possible
  • Ventricular pacing in atrial fibrillation with
    slow ventricular response

ACC/AHA/NASPE 2002 Guideline Update. Circ.
20021062145-2161.
62
Treatment of Syncope Due to Tachyarrhythmia
  • Atrial tachyarrhythmias
  • AVRT due to accessory pathway Ablate pathway
  • AVNRT Ablate AV nodal slow pathway
  • Atrial fib Pacing, linear/focal ablation for
    paroxysmal AF
  • Atrial flutter Ablate the IVC-TV isthmus of the
    re-entrant circuit for typical flutter
  • Ventricular tachyarrhythmias
  • Ventricular tachycardia ICD or ablation where
    appropriate
  • Torsade de pointes Withdraw offending drug or
    implant ICD (long QT/Brugada/short QT)
  • Drug therapy may be an alternative in many cases

Brignole M, et al. Europace. 20046467-537.
63
Neurally-Mediated Reflex Syncope
  • Vasovagal Syncope (VVS)
  • Carotid Sinus Syndrome (CSS)
  • Situational syncope
  • Post-micturition
  • Cough
  • Swallow
  • Defecation
  • Blood drawing, etc.

Brignole M, et al. Europace, 20046467-537.
64
Pathophysiology
Autonomic Nervous System
Benditt D, et al. Neurally mediated syncope
Pathophysiology, investigations and treatment.
Blanc JJ, et al. eds. Futura. 1996.
65
VVS Clinical Pathophysiology
  • Neurally-mediated physiologic reflex mechanism
    with two components
  • 1. Cardioinhibitory (? HR)
  • 2. Vasodepressor (? BP) despite heart beats, no
    significant BP generated
  • Both components are usually present

1
2
Wieling W, et al. In Benditt D, et al. The
Evaluation and Treatment of Syncope. Futura.
200311-22.
66
VVS Incidence
  • Most common form of syncope
  • 8 to 37 (mean 18) of syncope cases
  • Depends on population sampled
  • Young without SHD, ? incidence
  • Older with SHD, ? incidence

Linzer M, et al. Ann Intern Med. 1997126989.
67
VVS vs. CSS
  • In general
  • VVS patients younger than CSS patients
  • Ages range from adolescence to older adults
    (median 43 years)

Linzer M, et al. Ann Intern Med. 1997126989.
68
VVS Recurrences
  • 35 of patients report syncope recurrence during
    follow-up 3 years1
  • Positive HUT with gt6 lifetime syncope episodes
    recurrence risk gt50 over 2 years2

1Savage D, et al. STROKE. 198516626-29.
2Sheldon R, et al. Circulation. 199693973-81.
69
VVS Spontaneous
16 year-old male, healthy, athletic, monitored
for fainting.
From the files of DG Benditt, MD. U of M Cardiac
Arrhythmia Center
70
VVS Diagnosis
  • History and physical exam, ECG and BP
  • Head-Up Tilt (HUT) Protocol
  • Fast gt 2 hours
  • ECG and continuous blood pressure, supine, and
    upright
  • Tilt to 70, 20 minutes
  • Isoproterenol/Nitroglycerin if necessary
  • End point Loss of consciousness

60 - 80
Benditt D, et al. JACC. 199628263-275. Brignole
M, et al. Europace, 20046467-537.
71
VVS General Treatment Measures
  • Optimal treatment strategies for VVS are a
    source of debate
  • Treatment goals
  • Acute intervention
  • Physical maneuvers, eg, crossing legs or tugging
    arms
  • Lowering head
  • Lying down
  • Long-term prevention
  • Tilt training
  • Education
  • Diet, fluids, salt
  • Support hose
  • Drug therapy
  • Pacing

Brignole M, et al. Europace, 20046467-537.
72
VVS Tilt Training Protocol
  • Objectives
  • Enhance orthostatic tolerance
  • Diminish excessive autonomic reflex activity
  • Reduce syncope susceptibility/recurrences
  • Technique
  • Prescribed periods of upright posture against a
    wall
  • Start with 3-5 min BID
  • Increase by 5 min each week until a duration of
    30 min is achieved

Reybrouck T, et al. PACE. 200023(4 Pt.
1)493-498.
73
VVS Tilt Training Clinical Outcomes
  • Treatment of recurrent VVS
  • Reybrouck, et al. Long-term study
  • 38 patients performed home tilt training
  • After a period of regular tilt training, 82
    remained free of syncope during the
    follow-up period
  • However, at the 43-month follow-up, 29 patients
    had abandoned the therapy
  • Conclusion The abnormal autonomic reflex
    activity of VVS can be remedied. Compliance may
    be an issue.

Reybrouck T, et al. PACE. 200023493-498.
74
VVS Tilt Training Clinical Outcomes
  • Foglia-Manzillo, et al. Short-term study
  • 68 patients
  • 35 tilt training
  • 33 no treatment (control)
  • Tilt table test conducted after 3 weeks
  • 19 (59) of tilt trained and 18 (60) of controls
    had a positive test
  • Tilt training was not effective in reducing tilt
    testing positivity rate
  • Poor compliance in the majority of patients with
    recurrent VVS

Foglio-Manzillo G, et al. Europace.
20046199-204.
75
VVS Pharmacologic Treatment
  • Fludrocortisone
  • Beta-adrenergic blockers
  • Preponderance of clinical evidence suggests
    minimal benefit1
  • SSRI (Selective Serotonin Re-Uptake Inhibitor)
  • 1 small controlled trial2
  • Vasoconstrictors
  • 1 negative controlled trial (etilefrine)3
  • 2 positive controlled trials (midodrine)4,5

1Brignole M, et al. Europace, 20046467-537. 2Di
Girolamo E, et al. JACC. 1999331227-1230. 3Ravi
ele A, et al. Circ. 1999991452-1457.
4Ward C, et al. Heart. 19987945-49. 5Perez-Lugon
es A, et al. J Cardiovasc Electrophysiol.
200112(8)935-938.
76
Midodrine for VVS
Midodrine
Symptom-Free Interval
Fluid
p lt 0.001
0
Months
Perez-Lugones A, Schweikert R, Pavia S, et al. J
Cardiovasc Electrophysiol. 200112(8)935-938.
77
The Role of Pacing as Therapy for Syncope
  • VVS with HUT and cardioinhibitory
    response Class IIb indication for pacing
  • Three randomized, prospective trials reported
    benefits of pacing in select VVS patients
  • VPS I1
  • VASIS2
  • SYDIT3
  • Subsequent study results less clear
  • VPS II4
  • Synpace5
  • INVASY6

4Connolly S. JAMA. 20032892224-2229. 5Giada F.
PACE . 2003261016 (abstract). 6Occhetta E, et
al. Europace. 20046538-547.
1Connolly SJ. J Am Coll Cardiol.
19993316-20. 2Sutton R. Circulation.
2000102294-299. 3Ammirati F. Circ.
200110452-57.
78
VPS I (North American Vasovagal Pacemaker Study)
  • Objective To evaluate pacemaker therapy for
    severe recurrent vasovagal syncope
  • Randomized, prospective, single center
  • N54 patients
  • 27 DDD pacemaker with rate drop response
  • 27 No pacemaker
  • Inclusion Vasodepressor response
  • Primary outcome First recurrence of syncope

Connolly SJ. J Am Coll Cardiol. 19993316-20.
79
VPS I (North American Vasovagal Pacemaker Study)
100
90
80
No Pacemaker (PM)
70
60
2P0.000022
Cumulative Risk ()
50
40
30
Pacemaker
20
10
0
0
3
6
9
12
15
Time in Months
  • Results
  • 6 (22) with PM had recurrence vs. 19 (70)
    without PM
  • 84 RRR (2p0.000022)

Connolly SJ. J Am Coll Cardiol. 19993316-20.
80
VASIS (VAsovagal Syncope International Study)
  • Objective To evaluate pacemaker therapy for
    severe cardioinhibitory tilt-positive neurally
    mediated syncope
  • Randomized, prospective, multi-center
  • N42 patients
  • 19 DDI pacemaker (80 bpm) with rate hysteresis
    (45 bpm)
  • 23 No pacemaker
  • Inclusion Positive cardioinhibitory response
  • Primary outcome First recurrence of syncope

Sutton R. Circulation. 2000102294-299.
81
VASIS (VAsovagal Syncope International Study)
Pacemaker (PM)
100
80
p0.0004
Syncope-Free
60
40
No Pacemaker
20
0
2
3
4
5
6
Years
  • Results
  • 1 (5) with PM had recurrence vs. 14 (61)
    without PM

Sutton R. Circulation. 2000102294-299.
82
SYDIT (SYncope DIagnosis and Treatment)
  • Objective To compare the effects of cardiac
    pacing with pharmacological
    therapy in patients with
    recurrent vasovagal syncope
  • Randomized, prospective, multi-center
  • N93 patients
  • 46 DDD pacemaker with rate drop response
  • 47 Atenolol 100 mg/d
  • Inclusion Positive HUT with relative bradycardia
  • Primary outcome First recurrence of syncope

Ammirati F. Circulation. 200110452-57.
83
SYDIT (SYncope DIagnosis and Treatment)
1.0
Pacemaker (PM)
0.9
Syncope-Free
p0.0032
0.8
0.7
Drug
0.6
0
100
200
300
400
500
600
700
800
900
1000
Time (Days)
  • Results
  • 2 (4) with PM had syncope recurrence vs. 12
    (26) without PM

Ammirati F. Circulation. 200110452-57.
84
VPS II (Vasovagal Pacemaker Study II)
  • Objective To determine if pacing therapy reduces
    the risk of syncope in patients with vasovagal
    syncope
  • Randomized, double-blind, prospective,
    multi-center
  • N100 patients
  • 52 Only sensing without pacing
  • 48 DDD pacemaker with rate drop response
  • Inclusion Positive HUT with (HRxBP) lt 6000/min x
    mm Hg
  • Primary outcome First recurrence of syncope

Connolly S. JAMA. 20032892224-2229.
85
VPS II (Vasovagal Pacemaker Study II)
1.0
0.8
0.6
Only Sensing Without Pacing (ODO)
Cumulative Risk
0.4
Dual Chamber Pacing (DDD)
0.2
0
2
1
0
5
4
3
6
Months Since Randomization
  • Results
  • 33 with pacing had recurrence vs. 42 with only
    sensing (not statistically significant)

Connolly S. JAMA. 200328922242229.
86
SYNPACE (Vasovagal SYNcope and PACing)
  • Objective To determine if pacing therapy will
    reduce syncope relapses in patients with
    recurrent vasovagal syncope, compared to those
    with a pacemaker programmed to OFF
  • Randomized, double-blind, prospective,
    multi-center, placebo-controlled
  • N29 patients
  • 16 DDD PM with rate drop response programmed ON
  • 13 PM programmed OFF (OOO mode)
  • Inclusion Recurrent VVS and HUT with asystolic
    or mixed response
  • Primary outcome First recurrence of syncope

Raviele A.. Europace. 20013336341. Raviele A,
et al. Eur Heart J. 2004251741-1748.
87
SYNPACE (Vasovagal SYNcope and PACing)
1.0
0.9
p0.58
0.8
0.7
Pacemaker OFF
0.6
Syncope-Free
0.5
Pacemaker ON
0.4
0.3
0.2
0.1
0.0
0
200
400
600
800
1000
Days Since Randomization
  • Results
  • 50 with pacing ON had recurrence vs. 38 with
    pacing OFF (not statistically significant)

Raviele A, et al. Eur Heart J. 2004251741-1748.
88
INVASY (INotropy Controlled Pacing in VAsovagal
Syncope)
  • Objective To evaluate Closed Loop Stimulation
    (CLS), a form of rate-adaptive pacing using RV
    impedance, in preventing recurrence of VVS
  • Randomized, prospective, single-blind,
    multi-center
  • N50 patients
  • 41 CLS therapy
  • 9 Control (pacemaker programmed in DDI)
  • Inclusion Recurrent VVS and HUT with
    cardioinhibition
  • Primary outcome Recurrence of two VVSs during a
    minimum of 1 year of follow-up

Occhetta E, et al. Europace. 20046538-547.
89
INVASY (INotropy Controlled Pacing in VAsovagal
SYncope)
Closed Loop Stimulation (CLS)
P lt 0.0001
Syncope-Free
Control (DDI only)
3m
6m
9m
1y
2y
3y
Time Since Randomization
  • Results
  • Patients with CLS had no syncope recurrence and
    improved quality of life

Occhetta E, et al. Europace. 20046538-547.
90
Role of Pacing as Therapy for Syncope Summary
  • Three earlier studies single blind Bias?
  • Pacemaker implantation may modulate reflex
    syncope and autonomic responses1
  • Study results may differ based on pre-implant
    selection criteria and tilt-testing techniques
  • Pacing therapy is effective in some but not all
    (cardioinhibition vs. vasodepression)
  • In five pacing studies, syncope recurred in
    33/156 (21) of paced patients,
    72/162 (44) in non-paced
    patients (plt0.000)2

1Kapoor W. JAMA. 20032892272-2275. 2Brignole M,
et al.. Europace. 20046467-537.
91
CSS Carotid Sinus Syndrome
  • Syncope clearly associated with carotid sinus
    stimulation is rare (1 of syncope)
  • CSS may be an important cause of unexplained
    syncope/falls in older individuals
  • Prevalence higher than previously believed
  • Carotid Sinus Hypersensitivity (CSH)
  • No symptoms
  • No treatment

Kenny RA, et al. J Am Coll Cardiol.
2001381491-1496. Brignole M, et al. Europace.
20046467-537. Sutton R. In Neurally Mediated
Syncope Pathophysiology, Investigation and
Treatment. Blanc JJ, et al. eds. Armonk, NY
Futura1996138.
92
CSS Etiology
  • Sensory nerve endings in the carotid
    sinus walls respond to deformation
  • Deafferentation of neck muscles may contribute
  • Increased afferent signals to brain stem
  • Reflex increase in efferent vagal activity and
    diminution of sympathetic tone results in
    bradycardia and vasodilatation

Carotid Sinus
93
Falls Incidence, Recurrence, CSH
50 1
30 1
of Population
23 2
Incidence gt Age 65
Recurrence
CSH Present in Fallers gt Age 50 Presenting at ER
Carotid Sinus Hypersensitivity
1 J Am Geriatr Soc. 1995. 2 Richardson D, et al.
PACE. 199720820.
94
CSS Role of Pacing Syncope Recurrence Rate
  • Class I indication for pacing (AHA and BPEG)
  • Limit pacing to CSS that is
  • Cardioinhibitory
  • Mixed
  • DDD/DDI superior to VVI
  • Mean follow-up 6 months

57
Recurrence
6
Brignole M, et al. Eur JCPE. 19924247-254.
95
SAFE PACE Syncope And Falls in the Elderly
Pacing And Carotid Sinus Evaluation
  • Objective
  • Determine whether cardiac pacing reduces falls in
    older adults with carotid sinus
    hypersensitivity
  • Randomized controlled trial (N175)
  • Adults gt 50 years, non-accidental fall,
    positive CSM
  • Pacing (n87) vs. No Pacing (n88)
  • Results
  • More than 1/3 of adults over 50 years presented
    to the Emergency Department because of a fall
  • With pacing, falls ? 70
  • Syncopal events ? 53
  • Injurious events ? 70

Kenny RA. J Am Coll Cardiol. 2001381491-1496.
96
SAFE PACE
  • Conclusions
  • Strong association between non-accidental falls
    and cardioinhibitory CSH
  • These patients usually not referred for cardiac
    assessment
  • Cardiac pacing significantly reduced subsequent
    falls
  • CSH should be considered in all older adults who
    have non-accidental falls

Kenny RA, J Am Coll Cardiol. 2001 381491-1496.
97
Orthostatic Hypotension
  • Etiology
  • Drug-induced (very common)
  • Diuretics
  • Vasodilators
  • Primary autonomic failure
  • Multiple system atrophy
  • Parkinsons Disease
  • Postural Orthostatic Tachycardia Syndrome (POTS)
  • Secondary autonomic failure
  • Diabetes
  • Alcohol
  • Amyloid

Brignole M, et al. Europace, 20046467-537.
98
Treatment Strategies for Orthostatic Intolerance
  • Patient education, injury avoidance
  • Hydration
  • Fluids, salt, diet
  • Minimize caffeine/alcohol
  • Sleeping with head of bed elevated
  • Tilt training, leg crossing, arm pull
  • Support hose
  • Drug therapies
  • Fludrocortisone, midodrine, erythropoietin
  • Tachy-Pacing (probably not useful)

Brignole M, et al. Europace, 20046467-537.
99
Section IV
  • Special Issues

100
Syncope Diagnostic Testing in Hospital Strongly
Recommended
  • Suspected/known significant heart disease
  • ECG abnormalities suggesting potential
    life-threatening arrhythmic cause
  • Syncope during exercise
  • Severe injury or accident
  • Family history of premature sudden death

Brignole M, et al. Europace. 20046467-537.
101
SEEDS Syncope Evaluation in the Emergency
Department Study
Long-Term Clinical Outcomes
Survival Free from Death
Survival Free from Recurrence
100
100
90
90
Syncope Unit Group
Syncope Unit Group
80
80
Standard Care Group
Standard Care Group
P0.30
P0.72
70
70
2
1
0
2
1
0
Years
Years
  • Results
  • Syncope unit improved diagnostic yield in the ED
    and reduced hospital admission and length of stay

Shen W, et al. Circ. 2004110(24)3636-3645.
102
The Integrated Syncope Unit
  • To optimize the effectiveness of the evaluation
    and treatment of syncope patients at a given
    center
  • Best accomplished by
  • Cohesive, structured care pathway
  • Multidisciplinary approach
  • Core equipment available
  • Preferential access to other tests or therapy
  • Majority of syncope evaluations Out-patient or
    day cases

1Kenny RA, Brignole M. In Benditt D, et al. eds.
The Evaluation and Treatment of Syncope.
Futura200355-60. 2Brignole M, et al. Europace,
20046467-537.
103
Conclusion
  • Syncope is a common symptom with many causes
  • Deserves thorough investigation and appropriate
    treatment
  • A disciplined approach is essential
  • ESC guidelines offer current best practices

Brignole M, et al. Europace, 20046467-537.
104
Challenges of Syncope
  • Cost
  • Quality of life implications
  • Diagnosis and treatment
  • Diagnostic yield and repeatability of tests
  • Frequency and clustering of events
  • Difficulty in managing/treating/controlling
    future events
  • Appropriate risk stratification
  • Complex etiology

Olshansky B. In Grubb B and Olshansky B. eds.
Syncope Mechanisms and Management. Futura.
199815-71. Brignole M, et al. Europace,
20046467-537.
105
Brief Statement
  • Indications
  • 9526 Reveal Plus Insertable Loop Recorder
  • The Reveal Plus ILR is an implantable patient-
    and automatically activated monitoring system
    that records subcutaneous ECG and is indicated
    for
  • Patients with clinical syndromes or situations at
    increased risk of cardiac arrhythmias
  • Patients who experience transient symptoms that
    may suggest a cardiac arrhythmia
  • 6191 Activator
  • The Model 6191 Activator is intended for use in
    combination with a Medtronic Model 9526 Reveal
    Plus Insertable Loop Recorder.
  • Contraindications
  • There are no known contraindications for the
    implantation of the Reveal Plus ILR. However, the
    patients particular medical condition may
    dictate whether or not a subcutaneous,
    chronically implanted device can be tolerated.
  • Warnings/Precautions
  • 9526 Reveal Plus Insertable Loop Recorder
  • Patients with the Reveal Plus ILR should avoid
    sources of magnetic resonance imaging, diathermy,
    high sources of radiation, electrosurgical
    cautery, external defibrillation, lithotripsy,
    and radiofrequency ablation to avoid electrical
    reset of the device, and/or inappropriate
    sensing.
  • 6191 Activator
  • Operation of the Model 6191 Activator near
    sources of electromagnetic interference, such as
    cellular phones, computer monitors, etc., may
    adversely affect the performance of this device.
  • Potential Complications
  • Potential complications include, but are not
    limited to, body tissue rejection phenomena,
    including local tissue reaction, infection,
    device migration and erosion of the device
    through the skin.
  • 2090 Programmer
  • The Medtronic/Vitatron CareLink programmer system
    is comprised of prescription devices indicated
    for use in the interrogation and programming of
    implantable medical devices. Prior to use, refer
    to the Programmer Reference Guide as well as the
    appropriate programmer software and implantable
    device technical manuals for more information
    related to specific implantable device models.
    Programming should be attempted only by
    appropriately trained personnel after careful
    study of the technical manual for the implantable
    device and after careful determination of
    appropriate parameter values based on the
    patient's condition and pacing system used. The
    Medtronic/Vitatron CareLink programmer must be
    used only for programming implantable devices
    manufactured by Medtronic or Vitatron.
  • See the device manual for detailed information
    regarding the implant procedure, indications,
    contraindications, warnings, precautions, and
    potential complications/adverse events. For
    further information, please call Medtronic at
    1-800-328-2518 and/or consult Medtronics website
    at www.medtronic.com. To learn more about
    syncope, visit www.fainting.com.
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