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