ΑΠΡΟΣΦΟΡΕΣ ΘΕΡΑΠΕΙΕΣ ΑΠΙΝΙΔΙΣΤΗ ΑΙΤΙΕΣ ΠΡΟΛΗΨΗ ΠΑΝΑΓΙΩΤΗΣ ΚΟΡΑΝΤΖΟΠΟΥΛΟΣ

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1 ΑΠΡΟΣΦΟΡΕΣ ΘΕΡΑΠΕΙΕΣ ΑΠΙΝΙΔΙΣΤΗ ΑΙΤΙΕΣ ΠΡΟΛΗΨΗ ΠΑΝΑΓΙΩΤΗΣ ΚΟΡΑΝΤΖΟΠΟΥΛΟΣ Επίκουρος Καθηγητής Καρδιολογίας Πανεπιστημίου Ιωαννίνων

2 Implantable Cardioverter-Defibrillator Shocks: Epidemiology, Outcomes, and Therapeutic Approaches JAMA Intern Med. 2013;173(10): doi: /jamainternmed MEAN F/U MADIT II: 20 mo SCD-HeFT: 45.5 mo DEFINITE: 29 mo AVID: 18.2 mo Date of download: 7/12/2013 Copyright 2012 American Medical Association. All rights reserved.

3 Implantable Cardioverter-Defibrillator Shocks: Epidemiology, Outcomes, and Therapeutic Approaches JAMA Intern Med. 2013;173(10): doi: /jamainternmed Reasons for inappropriate implantable cardioverter-defibrillator (ICD) shock among patients with ischemic cardiomyopathy and reduced left ventricular ejection fraction who received a primary prevention ICD in the Multicenter Automatic Defibrillator Implantation Trial (MADIT Trial) Date of download: 7/12/2013 Copyright 2012 American Medical Association. All rights reserved.

4 During the follow-up period of 41 ±18 months, 13% experienced 1 inappropriate shocks.

5 Predictors of mortality related to ICD therapy

6 Meta-analysis / Studies included (until 2011): 9 trials of antiarrhythmic medication 3 of catheter ablation, and 5 evaluating enhanced ICD programming Heart Rhythm 2012;9:

7 Effect of interventions on ICD shocks Heart Rhythm 2012;9:

8 Impact of interventions on mortality Heart Rhythm 2012;9:

9 MADIT-RIT Study Overview Study Hypothesis: Study Design: Primary Endpoint: Secondary Endpoints: Number of Patients: Dual-chamber ICD or CRT-D devices with high-rate cutoff (>200bpm), or duration-delay (initial 60sec monitoring plus Rhythm ID detection will be associated with fewer 1st inappropriate therapies than standard/conventional programming (2.5sec >170bpm) without increase in mortality Randomized, 3-arm study of patients randomized 1:1:1 to either conventional, high-rate cutoff, or duration-delay programming First episode of inappropriate therapy (defined as shock or ATP) B arm vs. A arm C arm vs. A arm All-cause mortality Syncope 1500 from 98 centers US, Canada, Europe, Israel and Japan

10 MADIT-RIT Three Treatment Arms (abbreviated)* Arm A (Conventional) Arm B (High-rate) Zone 1: Zone 1: Zone 1: Arm C (Duration-delay) >170 bpm, 2.5s delay 170 bpm >170 bpm, 60s delay Onset/Stability Detection Enhancements ON ATP + Shock SRD 3 min initial Monitor only Rhythm ID Detection Enhancements ON ATP + Shock SRD Off Zone 2: Zone 2: Zone 2: >200 bpm, 1s delay >200 bpm, 2.5s delay >200 bpm, 12s delay Quick Convert TM ATP Shock Quick Convert TM ATP Shock Rhythm ID Detection Enhancements ON ATP + Shock SRD Off Zone 3 : >250 bpm, 2.5s delay Quick Convert TM ATP + Shock *All programming is within approved labeling. Rhythm ID and Quick Convert TM are trademarks of Boston Scientific Corporation

11 Cumulative Probability of First Inappropriate Therapy by Treatment Group

12 Cumulative Probability of Death by Treatment Group

13 Frequency and Hazard Ratios for Inappropriate Therapy, Death, and Syncope by Treatment Group

14 Any Appropriate and Inappropriate Therapy by Treatment Group Dr. Moss and his co-authors speculated that the decrease in mortality in this trial could have been related to the reduction in inappropriate shock and ATP therapies Unnecessary antitachycardia pacing increases mortality, possibly due to induction of ventriculararrhythmias.??

15 Patients were randomized 1:1 to programming with long- (n=948) or standard-detection (n=954) intervals. 187 bpm 300 bpm

16 Device Programming

17 Treatment Effect Regarding the Primary End Point and Its Components Mortality and arrhythmic syncope rates did not differ significantly between groups. JAMA 2013;309:

18 Secondary Efficacy Endpoint Results 45% reduction of inappropriate shocks Advance III Primary Results

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21 846 in the experimental group, 824 in the control group and monitored over a follow-up of 530±241 days 18 beats for detection 12 beats for detection 25 beats for detection, Aggressive SVT discr. settings J Cardiovasc Electrophysiol 2014 ;25(1): beats for detection

22 ΕΛΑΤΤΩΣΗ ΘΝΗΤΟΤΗΤΑΣ No difference in syncopal arrhythmic episodes

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24 ΣΥΓΚΡΙΣΗ ΤΩΝ ΤΡΙΩΝ ΤΕΛΕΥΤΑΙΩΝ ΜΕΛΕΤΩΝ MADIT-RIT ADVANCE III PROVIDE Mean LVEF 26 % 30 % 27 % B-blockers 93% 81 % 88 % ACE-I 68 % 81 % 60 % AF/AFl history 10 % - 30 %

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26 Frequency of Inappropriate Therapy in Patients Implanted with Dual Versus Single Chamber ICD Devices in the ICD Arm of MADIT CRT JCE 2013;24:

27 ΣΤΟΧΟΙ ΑΠΙΝΙΔΩΤΙΚΗΣ ΘΕΡΑΠΕΙΑΣ ΒΕΛΤΙΩΣΗ ΠΟΙΟΤΗΤΑΣ ΖΩΗΣ ΒΕΛΤΙΩΣΗ ΕΠΙΒΙΩΣΗΣ APPROPRIATE / INAPPROPRIATE THERAPIES Οι πρόσφορες θεραπείες δεν είναι ισοδύναμες με επεισόδια αιφνιδίου καρδιακού θανάτου. Οι απινιδωτικές θεραπείες έχουν προαρρυθμικό δυναμικό??? Οι εκφορτίσεις υποβαθμίζουν την ποιότητα ζωής, δημιουργούν ψυχολογικά προβλήματα και ελαττώνουν τη διάρκεια ζωής της μπαταρίας

28 MADIT RIT/ PROVIDE: Η αντιταχυκαρδική βηματοδότηση μπορεί να είναι επιβλαβής. Eg. VT acceleration, inappropriate ATP for atrial arrhythmias may lead to VT MADIT-RIT vs ADVANCE III / Difference in mortality Potential explanations 1. Chance? Neither study was powered to examine mortality. 2. The control group in ADVANCE III used a longer detection delay than in the control group of MADIT-RIT 3. ADVANCE III F/U 1 year while MADIT-RIT > 2 years 4. Lower EF in MADIT-RIT (26% vs 30% in ADVANCE III).

29 A random sample of 3,809 patients who experienced 1 or more spontaneous defibrillator shocks was evaluated. Patients were followed up for an average of 3.1±1.7 years after implant and 2.1 ±0.4 years after a first shock. First shock episodes 58.7% appropriate shocks

30 Survival Based on Rhythm Shocked

31 Matched comparison to no-shock group Risk of death Appropriate shock / HR: 2.82 Inappropriate shock / HR: 1.81

32 SLOW V.T. IS THERE A PROBLEM? ICDs were programmed with a detection zone of 187 b.p.m. Devices were programmed to an additional monitor zone for slow VTs at heart rates b.p.m. Pts were followed for a mean of 509 ± 308 days The incidence of slow VTs was low in only 12/200 patients (6%) No patient with slow VT suffered from syncope, palpitation, or decompensation leading to hospitalization.

33 M. Silver M.D. et al. HRS 2013 Shock-Less Trial Primary Results Improving Evidence-Based Shock Reduction Programming in ICD Patients 33 M. Silver M.D. et al. HRS 2013

34 Baseline Characteristics (%) or mean ± std Group 1: Before (n=2636) Group 2: After (n=1495) P values Age (years) 66.6 ± ± Male Primary prevention AF history Previous CABG Ischemic < CAD Class III AAD Single chamber Dual chamber CRT-D No differences for: LVEF, QRS, diastolic & systolic BP, new ICD system, NYHA, LBBB, RBBB, diabetes, ACE/ARB, beta blocker, Ca blocker, diuretics, statins Shock-Less Trial Primary Results

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39 ΣΥΣΤΑΣΕΙΣ ΓΙΑ ΜΕΙΩΣΗ ΑΠΡΟΣΦΟΡΩΝ ΘΕΡΑΠΕΙΩΝ (Circulation. 2012;126: ) (Circulation. 2013;128: )

40 ΣΥΣΤΑΣΕΙΣ ΓΙΑ ΜΕΙΩΣΗ ΑΠΡΟΣΦΟΡΩΝ ΘΕΡΑΠΕΙΩΝ Βελτιστοποίηση φαρμακευτικής αγωγής υποκείμενης νόσου π.χ. καρδιακής ανεπάρκειας Αντιαρρυθμική αγωγή/ β-αναστολείς, αμιωδαρόνη, σοταλόλη, κινιδίνη (Brugada), φλεκαϊνίδη (CPVT) Ablation όπου είναι απαραίτητο

41 ΣΥΣΤΑΣΕΙΣ ΓΙΑ ΠΡΟΓΡΑΜΜΑΤΙΣΜΟ ICD Single detection-therapy zone ( bpm) is recommended for primary prevention patients / Detection delays sec, 30/40 intervals Alternatively 2 zones: VT > bpm, VF> bpm 1-2 ATP sequences is sufficient in most cases / ATP during charging / For fast VT burst pacing more safe than ramp SVT Discriminators ON especially in secondary prevention Monitoring zone bpm Devices and algorhithms that detect and inhibit therapies in cases of EM noise, lead failure, T wave oversensing, etc. No advantage of dual chamber vs single chamber ICDs / Dual chamber in secondary prevention

42 ΕΞΑΤΟΜΙΚΕΥΣΗ ΘΕΡΑΠΕΙΑΣ ΠΑΡΑΔΕΙΓΜΑ 1 Άνδρας 37 ετών, ασυμπτωματικός, Brugada type I Θετικός ΗΦΕ, Εμφύτευση ICD 2010 (Single chamber, 1 zone VF 220/min, 30/40 intervals) Self-terminating VF in BS is not rare (28%) Europace 2013;15: Σεπτέμβριος 2013 ΣΥΓΚΟΠΤΙΚΟ επεισόδιο Detection 12/16 int. Polymorphic VT VF...

43 ΕΞΑΤΟΜΙΚΕΥΣΗ ΘΕΡΑΠΕΙΑΣ ΠΑΡΑΔΕΙΓΜΑ 2 ΑΝΔΡΑΣ 80 ΕΤΩΝ ICD προ 3ετίας Δετερογενής πρόληψη ZONES VT 160bpm/ VF 210 bpm ICM - LVEF 35% INCESSANT VT 12 ώρες διάρκεια Εμφάνιση με Shock Ολιγουρία Οξεία νεφρική ανεπάρκεια Νοσηλευόμενος