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Managing implantable defibrillator shocks Patients with ICD shocks: What is the risk? Frieder Braunschweig MD PhD FESC Karolinska University Hospital Stockholm, Sweden Evolution of ICD therapy Worldwide ICD implants (estim # per Year) 360 000 MADIT-CRT 300 000 240 000 CRT-D 180 000 120 000 60 000 FDA First Human Approval Implant 0 1980 1985 1990 SCD –HeFT DualChamber COMPANION ICDs MADIT-II •Transvenous Leads MUSTT •Biphasic Waveform AVID CASH MADIT CIDS 1995 2000 2005 2010 Patient with ICD shock (s) New clinical picture • Increasing incidence • Symptoms with a broad range of severity • Other medical conditions may be involved • Causes psychological distress and anxiety • Barrier to ICD implantation Who gets involved? ICDspecialist EP ICD-nurse - Pacemaker Family technician practitioner Patient with CRT ICD shock(s) Patient HF nurse/ Ambulance coordinator personal Emergency medicine Internist General Imaging specialist cardiologist Types of shock 1) Appropriate shocks - VF, VT 2) Unnecessary shocks - Haemodynamically tolerated NSVT - Haemodynamically tolerated VT sensitive for ATP 3) Inappropriate shocks - Supraventricular tachycardia (AF!) - Signal misinterpretation (EMG, interference, device failure) 4) Phantom shocks How common? Shocks (total) 70 60 (%) 50 appropriate inappropriate Annual shock rate appr 10% (appr), 7.5% (inappr) 40 30 20 10 0 AVID MADIT II DEFINITE SCD-HeFT COMPANION PREPARE 1997 2002 2004 2005 2004 2008 n=492 n=719 n=227 n=811 n=594 n=700 24/12M 22M 29M 45M 16M 12M Secondary Primary Primary Primary Primary Primary ICM + DCM ICM DCM ICM + DCM ICM + DCM ICM + DCM ICD ICD ICD ICD CRT-D ICD + CRT-D (single lead) Predictors of shock TOVA study: cohort study, n=1140 ICD, 95% secondary prevention Whang et al, Circulation. 2004;109:1386-1391 Predictors of appropriate therapy MADIT II Probability of first appropriate ICD therapy for VT or VF n=720 281 VT terminated by ATP (147 pts) 305 VT terminated by shock (108 pts) 115 VF terminated by shock (36 pts) Moss et al, Circulation. 2004;110:3760-3765 Predictors of appropriate therapy MADIT II Patients receiving 1 or more device therapies 140 139 120 VT therapies 30 VF therapies 25 30 VF therapies VT therapies 100 20 75 80 18 15 60 48 40 0 1 5 2 4 3 2 4 9 6 21 20 6 10 10 32 6 5 2 5 0 3 1 2 2 3 1 4 First Therapy: VT First Therapy: VF 54% of repeat episodes occurring within 24 h, 67% within 1 w, 93% within 6 M Further predictors of electrical therapy: • Higher NYHA-class • Interim MI was no predictor Moss et al, Circulation. 2004;110:3760-3765 1 5 Predictors of inappropriate shocks Inappropriate shocks over time (11.5% of pts) MADIT II AF (44%) SVT (36%) Inappr sensing (20%) Predictors of inappropriate shock Daubert et al JACC 2008;51:1357–65 Risk factors: appropriate therapies Patient - Previous ventricular arrhythmia - Previous myocardial infarction, (ischemia) - Symptomatic HF - Inappropriate drug treatment Betablockers (!), “antiarrhythmics” (?) - Distress, depression - Male gender - Smoking - Genetic susceptibility Device - Inappropriate programming Detection-rate / –duration, ATP Risk factors: inappropriate therapies Patient - History of AF, other SVT - Younger age - Non ischemic cardiomyopathy - Symptomatic HF - Inappropriate drug treatment (Betablockers !) - Distress - Smoking Device - Inappropriate programming Detection zones, SVT discrimination - Signal misclassification - System failure Risk factors: electrical storm Definition: 3 or more distinct VT/VF episodes within 24 h • More common in secondary (10-40%) vs primary prevention • No apparent cause in majority of cases • Potential triggering factors: - Drugs (pro-arrhythmia, non-compliance) - Worsening HF - Myocardial ischaemia - Emotional stress and anger - Alcohol excess - Electrolyte abnormalities - Early postoperative period Prognosis after ICD therapies MADIT II (ICD group analysis) Probability of CHF hospitalization Probability of CHF hospitalization 1.0 0.8 0.6 Post VF Therapy 0.4 Post VT Therapy 0.2 Prior to Therapy p<0.05 0 0 1 2 3 Years Patients at risk Post VF therapy 30 Post VT therapy 139 Prior to therapy 718 13 (0.31) 54 (0.26) 344 (0.19) 1 (0.48) 29 (0.29) 165 (0.25) Moss et al, Circulation. 2004;110:3760-3765 8 (0.36) 53 (0.31) Prognosis after ICD therapies MADIT II (ICD group analysis) Probability of survival 1.0 Prior to Therapy Survival 0.8 Post VT Therapy 0.6 0.4 Post VF Therapy 0.2 p<0.001 0 0 1 2 3 Years Patients at risk Prior to therapy 719 Post VT therapy 139 Post VF therapy 30 419 (0.94) 61 (0.82) 15 (0.80) 206 (0.89) 29 (0.74) 3 (0.49) Moss et al, Circulation. 2004;110:3760-3765 76 (0.83) 8 (0.74) 1 (0.32) Prognosis after ICD shock (s) COMPANION (CRT-D group analysis) Free from All-cause Mortality (%) Free from Pump Failure Death and HF Hospitalization (%) Saxon et al, Circulation. 2006;114:2766-2772 Prognosis after ICD shock (s) SCD-HeFT (ICD group analysis) n=811 (269 pts received shocks: 128 only appr, 87 only inappr, 54 both) Adjusted for baseline prognostic factors Death due to progressive HF: 42.9% Poole JE and al N Engl J Med 2008;359:1009-17 Poor prognosis after shock Possible explanations • Ventricular arrhythmia = harbinger of end stage heart failure • Atrial arrhythmia (inappr) = risk marker of heart failure • Cellular damage and negative inotropic effects, activation of signaling pathways in the molecular cascade of HF • Post traumatic stress Vicious circle of stress and arrhythmia Autonomic imbalance HR HRV Inflammation Distress (Anxiety / Depression) Tachyarrhythmia / shock Increased perception, dysfunctional appraisal, maladaptive coping Personality Pre-existing distress Social support Vicious circle of stress and arrhythmia Prognostic Impact of post-traumatic stress disorder (PTSD) 147 ICD patients, n=38 with a high PTSD score Ladwig KH et al, Arch Gen Psychiatry. 2008;65(11):1324-1330 Independent prognostic impact of shocks Sweeney MO, Heart Rhythm 2010;7:353–360 How can the risk be reduced? Optimizing the management of patients receiving ICD shocks • Acute work-up • Optimal programming • Optimization of medication (arrhythmia, ischemia, heart failure) • Ablation of supraventricular and ventricular substrates • Diagnosing and treating anxiety and distress • Psychosocial support • Education of non-electrophysiologists Europace in press Task force members: Frieder Braunschweig (chair), Giuseppe Boriani (co-chair) Alexander Bauer, Robert Hatala, Christoph Herrmann-Lingen, Josef Kautzner, Susanne S Pedersen, Steen Pehrson, Renato Ricci, Martin Schalij Summary ICD patients frequently suffer from appropriate, unnecessary and inappropriate shocks. The individual risk is modulated by a number of characteristics including the secondary or primary indication for the device, degree of LV impairment, heart failure etiology and severity and other factors. Summary II The burden of ICD-shock patients is increasing due to increasing implantation rates. Fortunately, modern empiric programming of ATP and detection algorithms results in a marked reduction of the individual risk of suffering from shocks. However, appropriate and possibly even inappropriate ICD shocks are associated with an increased risk for repeat arrhythmia and shocks, deteriorated heart failure and death. Therefore a comprehensive management strategy with the aim to reduce the number of shocks is mandatory. Electrical storm Risk of shock: primary vs secondary PainFREE Rx II Patients (n) Pts shocked Appropriate Inappropriate: Primary Prevention 248 20 % 11 % 9% Secondary Prevention 334 23 % 15 % 9% Sweeney et al, Circulation. 2005; 111:2898-2905 ns ns ns ns Appropriate vs unneccessary shocks Number of episodes 140 VF 10% 120 100 VT 58% 73% amenable to ATP FVT 32% 80 60 40 20 0 <200 200 220 240 260 280 300 320 340 360 380 400 420 440 >460 Median Cycle Length (ms) Wathen et al Circulation. 2004;110:2591-2596