Devices and the older patient with syncope
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Devices and the older Devices and the older patient with syncopepatient with syncope
Michael Gammage,Reader in Cardiovascular Medicine
MHRA Committee for Safety of Devices
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Falling Man, Rodin
Those who suffer from frequent and severe fainting often die suddenlyHippocrates, 1000 BC
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A brief history of devices….A brief history of devices….
Seymour Furman, cardiac surgeon in New York, first demonstrated effective endocardial pacing in a patient in 1958Pacing lead seemed most stable in the
RV apexSenning and Elmquist undertook first
fully implantable pacing procedure in Stockholm in 1958Device failed within 12 hours
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Moving forward 50 years….Moving forward 50 years….
• Implantable device therapy has moved on significantly to include three main categories• Pacing for bradycardia• Pacing to improve cardiac function
• Cardiac resynchronisation therapy• Implantable cardioverter defibrillators (ICDs)
• In addition, there are also implantable loop recorders (ILRs), also classified by the MHRA as Active Implantable Medical Devices (AIMDs)
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Does age matter with devices? Does age matter with devices?
• Is there age discrimination?• Reduced number of implants• Increased number of implants
• Do older patients respond differently?• Less response to device therapy/use• Greater response to device therapy/use
• Is syncope different in older people?• Less device-relevant pathology• More device-relevant therapy
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Is there age discrimination?Is there age discrimination?
• Reduced number of implants• Increased number of implants
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Data corrected for age and sex
(except CRT)
National variation in implant ratesNational variation in implant rates
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Pacemaker New Implant Rate UK 2005
y = 0.7175e0.106x
R = 0.994
y = 0.3547e0.1062x
R = 0.992
0
1,000
2,000
3,000
4,000
5,0006,000
7,000
8,000
9,000
10,000
11,000
12,0000 5
10
15
20
25
30
35
40
45
50
55
60
65
70
75
80
85
90
+
Age
New
impl
ants
per
mill
ion
popu
latio
n
Male
Female
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Patient Age –Patient Age –All Devices, All Devices,
New Implants 2007New Implants 2007
> 65 years = 84%
> 70 years = 76%
> 75 years = 62%
> 85 years = 23%
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Primary Aetiology Primary Aetiology at Implantat Implant
At least 70% of aetiologylikely to be age-related
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New Pacemaker Implant Rates – UK TrendsNew Pacemaker Implant Rates – UK Trends
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New ICD Implant Rates – UK TrendsNew ICD Implant Rates – UK Trends
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Do older patients respond Do older patients respond differently?differently?
• Less response to device therapy/use• Greater response to device
therapy/use• Different response to device
therapy/use
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Hazard Ratio
95% CI p value
VVI v DDD 1.03 0.86, 1.23 0.74
VVIR v DDD
0.89 0.75, 1.07 0.22No differences
UKPACE UKPACE – All cause mortality– All cause mortality
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Hazard Ratio
95% CI p value
VVI & VVIR
v DDD
1.05 0.78, 1.41 0.74
Time after entry to trial (years)Pro
port
ion
wit
h e
nd
poin
t
0.0 0.5 1.0 1.5 2.0 2.5 3.0
0.0
0.05
0.10
0.15
VVI/VVIRDDD
843827
710725
431394
Atrial Atrial fibrillationfibrillation
UKPACE UKPACE - Time to specified - Time to specified cardiovascular eventscardiovascular events
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Is syncope different in older Is syncope different in older people?people?
• Less device-relevant pathology?• More device-relevant therapy?
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Causes of SyncopeCauses of Syncope
• Neurally-mediated reflex syncopal syndromes• Vasovagal, carotid sinus, situational, neuralgia
• Orthostatic• Cardiac Arrhythmias
• Bradycardia, tachycardia• Structural Cardiac or Cardiopulmonary
Disease
William Stokes Robert Adams
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Causes of Loss of ConsciousnessCauses of Loss of ConsciousnessData pooled from 6
population-based studies performed in the 1980’s
N = 1499 patientsThe cause was
undetermined in 35% of all cases of syncope
Of those with a cardiac cause (n=245), the majority (n=195) were due to a primary arrhythmic mechanism
Causes of LOC
38%
17%10%
35%
NM & OrthostaticCardiacNeuro-psychiatricUnknown
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Causes of Loss of ConsciousnessCauses of Loss of ConsciousnessData pooled from 3
referral Syncope Units in 2001
N = 342 patientsThe cause was
undetermined in 18% of all cases of syncope
Of those with a cardiac cause (n=78), the majority (n=68) were due to a primary arrhythmic mechanism
Causes of LOC
58%23%
1%18%
NM & OrthostaticCardiacNeuro-psychiatricUnknown
Alboni P et al, JACC 2001;37:1921-8
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Prognostic stratificationPrognostic stratification
Risk stratification: • age > 45 years• history of congestive heart disease• history of ventricular arrhythmias• abnormal ECG
Arrhythmias or death within one year:
• 4 - 7% of patients with 0 factors• 58 - 80% in patients with 3 factors
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Catching the spontaneous Catching the spontaneous episode…episode…
• Implantable Loop Recorder• ~ £1500• Lasts ~ 12
months• Patient and/or
auto-activated
Evidence suggests higher diagnostic rate in elderly and confused patients
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Sudden Cardiac DeathSudden Cardiac Death
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Indications for ICD Indications for ICD www.nice.org.uk/TA95
Secondary preventionSurvivors of VT/VF
cardiac arrestSpontaneous VT
causing syncopeSustained VT
without syncope/cardiac arrest with LVEF < 35%, NYHA Class < III
Primary preventionMI > 4 weeks previously and
Either:LVEF < 35%, NYHA < III +Non-sustained VT on
Holter + Inducible VT on EP testingOr:LVEF < 30%, NYHA < III +QRS duration > 120 msec
• Familial cardiac condition with risk of sudden death
No mention of age!
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ConclusionsConclusions
• No clear evidence for age discrimination with regard to device use in older patients
• Older patients are more likely to have syncope with underlying pathology requiring pacing or ICD therapy
• Older patients may be less suitable for ICDs by virtue of co-existing pathology
• Older patients may have a higher diagnostic yield from implantable loop recorders