Devices and the older patient with syncope Michael Gammage, Reader in Cardiovascular Medicine MHRA...
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Transcript of Devices and the older patient with syncope Michael Gammage, Reader in Cardiovascular Medicine MHRA...
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
Falling Man, Rodin
Those who suffer from frequent and severe fainting often die suddenlyHippocrates, 1000 BC
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
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)
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
Is there age discrimination?Is there age discrimination?
• Reduced number of implants• Increased number of implants
Data corrected for age and sex
(except CRT)
National variation in implant ratesNational variation in implant rates
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
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%
Primary Aetiology Primary Aetiology at Implantat Implant
At least 70% of aetiologylikely to be age-related
New Pacemaker Implant Rates – UK TrendsNew Pacemaker Implant Rates – UK Trends
New ICD Implant Rates – UK TrendsNew ICD Implant Rates – UK Trends
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
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
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
Is syncope different in older Is syncope different in older people?people?
• Less device-relevant pathology?• More device-relevant therapy?
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
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
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
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
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
Sudden Cardiac DeathSudden Cardiac Death
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!
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