ICD and SCD prevention in Europe How to better prevent Sudden Cardiac Death in the future ICD and beyond

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1 ICD and SCD prevention in Europe How to better prevent Sudden Cardiac Death in the future ICD and beyond K.-H. Kuck Asklepios Klinik St. Georg Hamburg, Germany

2 Disclosure Statement Research Grants Consultant / Advisory Board Ownership Interests Speaker s Bureau Honoraria Biosense Webster, Stereotaxis, Medtronic, St. Jude, Cordis, Prorhythm, Cryocath St. Jude, Edwards, Stereotaxis None None Fellowship Support None Other Off-label drugs/devices None None

3 The Wall Street Journal, November 16,2009

4 Sudden cardiac death Risk identification in high risk and moderate risk patients Prevention of SCD in elderly patients women

5 Profile of the sudden death victim 1) No history of cardiac disease 45% 2) Low-medium risk post MI 40% 3) High risk heart disease 13% (LVEF < 35%) 4) Monogenic arrhythmic disease 2%

6 Sudden cardiac death Issues The highest-risk subgroups constitute only a small proportion of the total number of deaths annually The majority of episodes of SCD actually occur in those with low- to intermediate-risk factors

7 Population Subsets / Incidence of Sudden Cardiac Death / Total Population Burden Mäikallio TH et al; European Heart Journal 2005; 26:

8 Risk stratification for SCD At present, methods for identification of high-risk patients without compromised LVEF are lacking. Consequently, prophylactic ICD implantation (or other prophylactic therapy) has never been tested in these patients. Hence, adequately potent risk stratification methods need to be first demonstrated in patients with preserved LVEF before any risk reduction prophylaxis can be attempted.

9 Risk stratification for SCD Problem: Rate of appropriate ICD interventions for high risk patients is low for both indications 20%/y for secondary prevention 10%/y for primary prevention These numbers become more or less stable after 2-3 years The number of appropriate ICD shocks overestimates in up to 50% the number of SCD s

10 Risk stratification for SCD Need for better risk stratification beyond LVEF In secondary prevention, Reduction of patients who will never use the ICD? In primary prevention Reduction of patients, who will never use the ICD? Idenfication of patients with LVEF 35%? Identification of patients with normal hearts, but ion channel disease?

11 Risk stratification for SCD Identification of patients at risk Golden standard EF < 35% New non invasive parameters Heart rate turbulence/deceleration capacity Fragmented QRS Surface ECG Magnetic field imaging

12 Method of Magnet ic Field Imaging Multi channel mangetic sensor (55 superconducting quantum interference device sensors Recognizing magnetic field of few picotesla) inside of a magnetically shielded room

13 QRS -Fragmentation Normal fragmentation Abnormal High grade fragmentation DCM, EF < 25 %

14 Distribution of QRS-Fragmentation AK St. Georg, Hamburg, Germany T. Tönnis, K.-H. Kuck, Unpublished

15 Risk stratification for SCD Need for better risk stratification beyond LVEF In secondary prevention, Reduction of patients who will never use the ICD? In primary prevention Reduction of patients, who will never use the ICD? Idenfication of patients with LVEF 35%? Identification of patients with normal hearts, but ion channel disease?

16 Risk stratification for SCD Bauer A et al, Eur Heart J 2009; 30,

17 Risk stratification for SCD Bauer A et al, Eur Heart J 2009; 30,

18 Risk stratification for SCD Bauer A et al, Eur Heart J 2009; 30,

19 Sudden cardiac death Issues The ICD reduces SCD and thereby total mortality, But its benefit is questionable for Elderly patients Women Patients with DCM

20 ICD in elderly patients Based on published medians, standard deviations, and interquartile ranges of major ICD randomized trials, the average age of enrolled subjects is 58 to 66 years, and less than 25% are older than 75 years. The average age of patients at the time of study enrolment was between 58 and 65 years in the secondary prevention trials and 58 and 66 years in the primary prevention trials.

21 AVID,CASH,CIDS-Master Database Healey JS, Kuck KH et al, European Heart Journal (2007) 28,

22 AVID,CASH,CIDS-Master Database Healey JS, Kuck KH et al, European Heart Journal (2007) 28,

23 Comparison ACT Reg. and NCDR Demographics I ACT Registry N (%) NCDR N (%) p ( 2 test) Age Group (2.6) 394 (8.6) 918 (20.1) 126 (27.6) 1326 (29.0) 548 (12.0) 2600 (3.5) 6113 (8.2) (19.2) (27.6) (29.6) 9243 (12.4) 0.2 Gender Male Female 3413 (74.8) 1153 (25.2) (73.1) (26.9) 0.2 Prevention Type Primary Prevention Secondary Prevention 3570 (78.2) 996 (21.8) (80.9) (19.1) < Epstein et al. Heart Rhythm 2009;6:

24 ICD in elderly patients Epstein AE et al, Heart Rhythm 2009;6:

25 Sudden cardiac death Issues The ICD reduces SCD and thereby total mortality, But its benefit is questionable for Elderly patients Women Patients with DCM

26 ICD in Women Santangeli et al, Heart Rhythm 2010;7:

27 ICD in Women Santangeli et al, Heart Rhythm 2010;7:

28 ICD in Women Santangeli et al, Heart Rhythm 2010;7:

29 SCD Conclusions SCD occurs in % in the overall population High risk patients represent only 14% of the overall SCD population Better risk stratification needed for high risk and moderate risk patients to optimize costeffectiveness of ICD therapy Benefit of ICD questionable in elderly patients and in women