Preventing Sudden Death Current & Future Role of ICD Therapy
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1 Preventing Sudden Death Current & Future Role of ICD Therapy Derek V Exner, MD, MPH, FRCPC, FACC, FAHA, FHRS Professor, Libin Cardiovascular Institute of Alberta Canada Research Chair, Cardiovascular Clinical Trials Canada Research Chairs ACC
2 Choose your electrician wisely!
3 Derek V. Exner - Disclosures Consulting & Honoraria Speakers Bureau Equipment donations Research Support Investor Salary & Grants Boehringer Ingelheim, GE Healthcare, Medtronic, Sanofi-Aventis, St Jude Medical Biotronik, Boston Scientific, GE Healthcare, Medtronic, St Jude Medical AudiCor, Cambridge Heart, GE Healthcare, Roche Diagnostics, Sorin / ELA Cambridge Heart, Heart Force Medical, GE Healthcare, Medtronic, St Jude Medical Analytics4Life Alberta AET, CIHR, CRC, HSF Alberta, JC Anderson Legacy Foundation, WED.
4 Overview Sudden death Epidemiology Risk quantification ICD Therapy in 2013 Indications Expectations Unanswered questions
5 Sudden Death / Sudden Cardiac Arrest Cardiovascular death < 1 hour of symptoms
6 Deaths per year Magnitude 500, , , , ,000 0 Breast Lung Stroke Sudden Cancer Cancer Death More deaths than others combined
7 What Proportion of Sudden Deaths are Arrhythmic? 1. 20% 2. 40% 3. 60% 4. 80%
8 Sudden Death: Diverse Mechanisms VF Ambulatory Brady/EM D Other Awaiting Transplant VT/VF Brady/EMD Rapid VT Am J Cardiol 1989;117:151-9 Circulation 1989;80:
9 Population Subgroups Prior MI Heart Failure Population Attributable Risk % of events (prevalence) Individual risk (incidence) 0% 0 25% 50% 75% Rea AJC 2004;93:
10 Who is Indicated for an ICD? 1. Prior cardiac arrest / sustained VT 2. CAD & EF < 35% 3. CAD & EF < 30% 4. 1 & & 3
11 Risk Groups Odds ratio (95% confidence interval) Mortali Reducti AVID (n = 1,016) 0.59 (0.43, 0.81) 8.2% Spontaneous or Inducible Ventricular Arrhythmias CIDS (n = 659) 0.81 (0.57, 1.14) 4.3% CASH (n = 288) 0.71 (0.43, 1.18) 8.1% MADIT I (n = 196) 0.30 (0.15, 0.59) 22.8% MUSTT (n = 514) 0.34 (0.22, 0.53) 23.0% MADIT II (n = 1,232) 0.68 (0.50, 0.92) 5.4% Heart Failure or LV Dysfunction Alone AMIOVIRT (n = 103) 0.86 (0.27, 2.75) 1.7% CAT (n = 104) 0.76 (0.33, 1.80) 5.4% COMPANION (n = 903) 0.64 (0.46, 0.90) 7.3% SCD-HEFT (n = 1,676) 0.70 (0.56, 0.87) 6.8% DEFINITE (n = 458) 0.66 (0.39, 1.11) 5.2% CABG-Patch (n = 900) 1.11 (0.81, 1.52) LV dysfunction in Specific Circumstances DINAMIT (n = 674) 1.12 (0.76, 1.67) BEST-ICD (n = 138) 1.17 (0.39, 3.48) IRIS (n = 898) 1.01 (0.75, 1.36) Overall 0.72 (0.60, 0.86) Favors ICD Exner Randomized Trials of ICD Therapy 2011
12 Recommendations - Chronic Heart Failure Implantable cardioverter-defibrillator (ICD) Recommend for history of hemodynamically significant or sustained ventricular arrhythmia (secondary prevention). Consider for primary prevention: i. Ischemic LVD, NYHA II-III, EF 35%, measured > 1 m post MI, & > 3 m post revascularization ; ii. Ischemic LVD, NYHA class I, & EF 30% > 1 m post MI, & < 3 m post revascularization ; iii. Nonischemic LVD, NYHA class II-III, EF 35%, measured > 9 m after optimal medical therapy. For ALL: Strong Recommendation High Quality Evidence
13 Primary Prevention ICD Therapy Use Is: 1. Too High 2. About Right 3. To Low
14 New ICD Implants per Million Territories 125 BC 122 AB 120 SK 105 MB 185 ON 152 QC 170 Atlantic 186 Crysler Industry Data 2010
15 Regarding My Enthusiasm for Primary Prevention ICD Therapy: 1. I am keen 2. I am not keen due to the risk of shocks 3. I am not keen due to an inability to predict who will benefit 4. I am not keen due to the risk of long-term complications (leads, redo procedures) 5. I am not keen due to poor accessibility
16 Proportion (%) Relying Solely On Low LVEF Fails to Identify Most of Those at Risk Most Identified Are Not At High Risk 25 0 Exner. Curr Opin Cardiol 2009, 24:61 7
17 Clinical Risk Stratification: MADIT II Predictors of ICD benefit age > 70, NYHA 3 or 4, Elevated urea (> 26 mg/dl / (> 9.3 mmol/ L) QRS d > 120 ms, Atrial fibrillation. None of the 5 risk factors (n = 345; 31%) HR for ICD therapy 0.96 (95% CI 0.44, 2.07); p = 0.91 > 1 risk factor (n = 786; 69%) HR for ICD therapy 0.51 (95% CI 0.37, 0.70); p < Goldenberg et al., JACC 2008;51:288-96
18 Based on data from SCD-HeFT, over the initial 5 years, patients receiving a primary prevention ICD should expect? 1. 10% risk of shocks; 95% for VT/VF 2. 25% risk of shocks; 80% for VT/VF 3. 33% risk of shocks; 65% for VT/VF 4. 50% risk of shocks; 50% for VT/VF
19 Shocks: Necessary & Appropriate? - 1 in 3 ICD recipients in SCD-HeFT received shocks - Inappropriate 2-fold higher risk of death - Appropriate 5-fold higher risk of death NSVT 3% VT / VF 65% SVT 20% OS 12% Poole et al. N Engl J Med 2008;359:
20 Shock Reduction Algorithms 99.2% of all VT/VF episodes detected without delay Time to Development of Shocks for VT/VF Time to Development of Inappropriate Shocks Reduced from 30.7% to 26.1% Reduced from 23.5% to 8.4% Volosin, Exner, et al. JCE 2011;22:280-9
21 Range of NID Settings Time to Development of Inappropriate shocks Original NID = 18/24 Virtual ICD NID = 18/24 NID = 24/32 NID = 30/40 Volosin, Exner, et al. JCE 2011;22:280-9
22 MADIT-RIT: Shock Reduction ~ 80% reduction in inappropriate ICD therapies NEJM 2012;367(24):
23 MADIT-RIT: Reduced Mortality ~ 50% reduction in mortality (6.6% vs. 3.2%) NEJM 2012;367(24):
24 = 1,676) 0.70 (0.56, 0.87) (n = COMPANION 903) (n = 903) 0.64 (0.46, 0.90) 0.6 = 458) 0.66 (0.39, 1.11) = 1,676) SCD-HEFT ICD (n = 1,676) Therapy: Recent 0.70 MI (0.56, 0.87) 0.7 (n = 458) = DEFINITE 900) (n = 458) (0.39, (0.81, 1.11) 1.52) ) Odds 1.12 (0.76, ratio 1.67) (n = CABG-Patch 900) (n = 900) (95% confidence 1.11 (0.81, interval) 1.52) 1.1 = 138) 1.17 (0.39, 3.48) 674) DINAMIT (n = 674) (0.43, (0.76, 0.81) 1.67) 1.1 ) 1.01 (0.75, 1.36) = 138) BEST-ICD (n = 138) (0.57, (0.39, 1.14) 3.48) ) IRIS (n = 898) (0.43, (0.75, (0.60, 1.18) 1.36) 0.86) (0.15, 0.59) Overall (0.22, (0.60, 0.53) 0.86) 0.7 Favors ICD ) Favors ICD Favors ICD 0.68 (0.50, 0.92) 0.72 (0.60, 0.86) 1.01 (0.75, 1.36) ) 1.12 (0.76, 1.67) = 900) 1.11 (0.81, 1.52) 58) 0.66 (0.39, 1.11) 1,676) 0.70 (0.56, 0.87) = 903) 0.64 (0.46, 0.90) Exner Randomized Trials of ICD Therapy ) 0.86 (0.27, 2.75) 0.76 (0.33, 1.80) Favors ICD 38) 1.17 (0.39, 3.48)
25 Use of ICD Therapy Early After MI DINAMIT N = 674 EF < 0.35 (6-40 d post-mi) Impaired HR variability IRIS N = 898 EF < 0.40 (5-31 d post-mi) Elevated HR +/- NSVT Hohnloser. Hohnloser NEJM et 2004;351: al, Steinbeck. Steinbeck NEJM et 2009;361: al, NEJM 2004;351: NEJM 2009;361:
26 DINAMIT IRIS Hohnloser. NEJM 2004;351: Steinbeck. NEJM 2009;361:
27 Development of a Cardiac Arrest Autonomic Nervous System Underlying Fixed Substrate Dynamic Substrate Moss & Zareba J Electrocardiol 2003;36:101-8
28 Holter, Modified Moving Average TWA J Appl Physiol 2002;92:541-9 J Am Coll Cardiol 2011;58;
29 RR interval (ms) Heart Rate Turbulence (HRT) Reflex response to perturbation pts (post-mi) Holter < 14 d > 3-fold higher risk of death (indep t) Validation in multiple studies. Consistent utility. PVC # of RR interval Schmidt et al. Lancet 1999;353: Bauer et al. JACC 2008;52:
30 RR interval (ms) Heart Rate Turbulence (HRT) Reflex response to perturbation pts (post-mi) Holter < 14 d > 3-fold higher risk of death (indep t) Validation in multiple studies. Consistent utility. HRT onset HRT slope PVC # of RR interval Schmidt et al. Lancet 1999;353: Bauer et al. JACC 2008;52:
31 Combined Parameter Assessment 322 post-mi patients serial assessment (2-4 & weeks) HRT + TWA & EF < 0.50 Later testing more accurate 6-fold higher risk with abnormal HRT + TWA Sensitivity: 55% Positive PV: 27% Negative PV: 96% Remaining Cardiac Death or Cardiac Arrest Exner et al. JACC 2007;50:
32 Risk Estimation Following Infarction Noninvasive Evaluation: ICD efficacy EF 0.36 to mo. post-mi > 3 mo. post-revasc. < 80 years & without dialysis, perm AF or AAD Holter Abnormal TWA + HRT Registry Minimum follow-up: 2 years Mean follow-up: 5 years 1 outcome: mortality 2 outcomes: cost & QoL Usual Care Alone Usual Care + ICD
33 Summary Sudden death remains an important issue Post-MI patients are at risk EF alone is a poor discriminator The recommendations for ICD therapy are based on many large randomized trials Clinical risk scores exist to maximize benefit Shock reduction is here to stay Unanswered questions persist (post-mi)
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