1. Devices and the older patient with syncope Michael Gammage, Reader in Cardiovascular Medicine MHRA Committee for Safety of Devices

2. Falling Man, Rodin Those who suffer from frequent and severe fainting often die suddenly Hippocrates, 1000 BC

3. A brief history of devices…. Seymour Furman, cardiac surgeon in New York, first demonstrated effective endocardial pacing in a patient in 1958 Pacing lead seemed most stable in the RV apex Senning and Elmquist undertook first fully implantable pacing procedure in Stockholm in 1958 Device failed within 12 hours

4. 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)

5. 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

6. Is there age discrimination? Reduced number of implants Increased number of implants

7. Data corrected for age and sex (except CRT) National variation in implant rates

9. Patient Age – All Devices, New Implants 2007 > 65 years = 84% > 70 years = 76% > 75 years = 62% > 85 years = 23%

10. Primary Aetiology at Implant At least 70% of aetiology likely to be age-related

11. New Pacemaker Implant Rates – UK Trends

12. New ICD Implant Rates – UK Trends

16. Do older patients respond differently? Less response to device therapy/use Greater response to device therapy/use Different response to device therapy/use

17. Time after entry to trial (years) Mortality proportion 012345 0.0 0.2 0.4 0.6 0.8 VVI VVIR DDD 177215461079332124 Hazard Ratio 95% CIp value VVI v DDD1.030.86, 1.230.74 VVIR v DDD 0.890.75, 1.070.22 No differences UKPACE – All cause mortality

18. Hazard Ratio 95% CIp value VVI & VVIR v DDD 1.050.78, 1.410.74 Time after entry to trial (years) Proportion with endpoint 0.00.51.01.52.02.53.0 0.0 0.05 0.10 0.15 VVI/VVIR DDD 843 827 710 725 431 394 Atrial fibrillation UKPACE - Time to specified cardiovascular events

19. Is syncope different in older people? Less device-relevant pathology? More device-relevant therapy?

20. Causes 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

21. Causes of Loss of Consciousness Data pooled from 6 population-based studies performed in the 1980’s N = 1499 patients The 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 & Orthostatic Cardiac Neuro-psychiatric Unknown

22. Causes of Loss of Consciousness Data pooled from 3 referral Syncope Units in 2001 N = 342 patients The 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 & Orthostatic Cardiac Neuro-psychiatric Unknown Alboni P et al, JACC 2001;37:1921-8

23. Prognostic 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

24. Catching the spontaneous episode… Implantable Loop Recorder ~ £1500 Lasts ~ 12 months Patient and/or auto-activated Evidence suggests higher diagnostic rate in elderly and confused patients

25. Sudden Cardiac Death

26. Indications for ICD Indications for ICD www.nice.org.uk/TA95 Secondary prevention Survivors of VT/VF cardiac arrest Spontaneous VT causing syncope Sustained VT without syncope/cardiac arrest with LVEF < 35%, NYHA Class < III Primary prevention MI > 4 weeks previously and Either: LVEF < 35%, NYHA < III + Non-sustained VT on Holter + Inducible VT on EP testing Or: LVEF < 30%, NYHA < III + QRS duration > 120 msec Familial cardiac condition with risk of sudden death No mention of age!

27. Conclusions 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