Ενδείξεισ εμφύτευςησ απινιδωτή ςτην «γκρίζα ζώνη» Γεώργιοσ Ανδρικόπουλοσ, MD, PhD, Αν. Δ/ντήσ Καρδιολογικήσ Κλινικήσ ΓΝΑ «Ερρίκοσ Ντυνάν»

Transcription

1 Ενδείξεισ εμφύτευςησ απινιδωτή ςτην «γκρίζα ζώνη» Γεώργιοσ Ανδρικόπουλοσ, MD, PhD, Αν. Δ/ντήσ Καρδιολογικήσ Κλινικήσ ΓΝΑ «Ερρίκοσ Ντυνάν»

2 Major Implantable Cardioverter-Defibrillator Trials for Prevention of Sudden Cardiac Death Trial Year Patients (n) Inclusion Criterion: LVEF Additional Study Features Hazard Ratio* 95% CI p MADIT I < 35% NSVT and EP ( ) p=0.009 MADIT II < 30% Prior MI 0.69 ( ) p=0.016 CABG-Patch < 36% +SAECG and CABG 1.07 ( ) p=0.64 DEFINITE < 36% NICM, PVCs or NSVT 0.65 ( ) p=0.08 DINAMIT < 35% 6-40 days post-mi and Impaired HRV 1.08 ( ) p=0.66 SCD-HeFT < 35% Prior MI or NICM 0.77 ( ) p=0.007 AVID < 40% Prior cardiac Arrest, or Unstable VT CASH Mean < 45% ±18 at baseline CIDS < 35% Prior cardiac Arrest, Unstable VT, or Syncope 0.62 ( ) p<0.02 Prior cardiac arrest sided p= ( ) NS Epstein A, et al. ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities. J Am Coll Cardiol 2008; 51:e1 62. Table 5.

3 Implantable Cardioverter-Defibrillators I IIa IIb III I IIa IIb III I IIa IIb III ICD therapy is indicated in patients who are survivors of cardiac arrest due to ventricular fibrillation or hemodynamically unstable sustained VT after evaluation to define the cause of the event and to exclude any completely reversible causes. ICD therapy is indicated in patients with structural heart disease and spontaneous sustained VT, whether hemodynamically stable or unstable. ICD therapy is indicated in patients with syncope of undetermined origin with clinically relevant, hemodynamically significant sustained VT or VF induced at electrophysiological study. All primary SCD prevention ICD recommendations apply only to patients who are receiving optimal medical therapy and have reasonable expectation of survival with good functional capacity for more than 1 year.

4 Implantable Cardioverter-Defibrillators I IIa IIb III I IIa IIb III I IIa IIb III I IIa IIb III ICD therapy is indicated in patients with LVEF less than or equal to 35% due to prior MI who are at least 40 days post-mi and are in NYHA functional Class II or III. ICD therapy is indicated in patients with nonischemic DCM who have an LVEF less than or equal to 35% and who are in NYHA functional Class II or III. ICD therapy is indicated in patients with LV dysfunction due to prior MI who are at least 40 days post-mi, have an LVEF less than or equal to 30%, and are in NYHA functional Class I. ICD therapy is indicated in patients with nonsustained VT due to prior MI, LVEF less than or equal to 40%, and inducible VF or sustained VT at electrophysiological study. All primary SCD prevention ICD recommendations apply only to patients who are receiving optimal medical therapy and have reasonable expectation of survival with good functional capacity for more than 1 year.

5 Recommendation in patients with heart failure in New York Heart Association function class III/IV

6 Recommendation in patients with heart failure in New York Heart Association function class II NEW

7 Εμφυτεφςεισ ζναντι αςθενών με ζνδειξη ςτην Ευρώπη

8 Γιατί αυτή η ανομοιογένεια ςτην εφαρμογή των ενδείξεων ςτην Ευρώπη;

9 MADIT-II enrolled 1232 patients with a myocardial infarction 1 month before entry into the study and an EF 30%. Patients were randomly assigned in a 3:2 ratio to receive either an implanted defibrillator or non-icd conventional medical therapy Conclusion: Our findings demonstrate a sustained 8- year survival benefit with primary ICD therapy in the MADIT-II population Goldenberg I, et al. Circulation. 2010;122:

10 (ESC 2010 presented by Dr Cleland)

11 Η ΑΠΟΣΕΛΕΜΑΣΙΚΟΣΗΣΑ ΚΑΙ ΣΟ ΚΟΣΟ ΣΩΝ ΤΚΕΤΩΝ ΠΡΕΠΕΙ ΝΑ ΕΚΣΙΜΑΣΑΙ Ε ΜΑΚΡΟ ΧΡΟΝΟ ΠΑΡΑΚΟΛΟΤΘΗΗ (Basic principles of cost-effectiveness analyses)

12 EHRA Expert Consensus Statement on the management of cardiovascular implantable electronic devices in patients nearing end of life or requesting withdrawal of therapy Are cardiac rhythm management devices similar or different to other therapies? Europace (2010) 12,

13 Incremental Cost per Life-Year Saved Cost Effectiveness of ICDs $ $ $ $ $ $ $ $ $8.461 $ ICD $ MADIT $ $ ICD COMPANION* estimate ICD MADIT II* estimate SCD-HeFT $ $ $ $ ICD AVID $ $ Unattractive Expensive Borderline Cost-Effective $0 PTCA CABG (Chronic CAD, (Chronic CAD, severe angina, mild angina, 1 VD) 3 VD) Primary coronary stenting (CAD, Angina, 1 VD, Male, age 55) Hypertension therapy (Diastolic mmhg) Cardiac Transplant (CHF, transplant candidate) PTCA Lovastatin (Chronic (chol. = 290 mg/dl, CAD, mild 50 yrs old, angina, male, no risk 1 VD) factors) *Adapted from Moss AJ. Presentation at Satellite Symposium, Cost-Effectiveness of Device Therapy in the Heart Failure Population, Heart Failure Society of America Annual Meeting September 23, ** Feldman AM. Presented at American College of Cardiology 2005 Scientific Sessions; March 6-9, 2005; Orlando, FL

14 NICE Assessments of CPLYS ( ) Manufacturers NICE CRT-P 15,600 11,600 CRT-D 22,400 23,200 ICD secondary prevention 26,000 28,000 ICD primary prevention 27,000 33,000 NICE Technology Assessment 120 May 2007 NICE Technology

15

16

17

18 Implantable Cardioverter-Defibrillators?? I IIaIIbIII I IIaIIbIII I IIaIIbIII I IIaIIbIII I IIaIIbIII ICD implantation is reasonable for patients with unexplained syncope, significant LV dysfunction, and nonischemic DCM. ICD implantation is reasonable for patients with sustained VT and normal or near-normal ventricular function. ICD implantation is reasonable for patients with HCM who have 1 or more major risk factors for SCD. ICD implantation is reasonable for the prevention of SCD in patients with arrhythmogenic right ventricular dysplasia/cardiomyopathy (ARVD/C) who have 1 or more risk factors for SCD. ICD implantation is reasonable to reduce SCD in patients with long- QT syndrome who are experiencing syncope and/or VT while receiving beta blockers. All primary SCD prevention ICD recommendations apply only to patients who are receiving optimal medical therapy and have reasonable expectation of survival with good functional capacity for more than 1 year. See Section 3.2.4, Hypertrophic Cardiomyopathy, in the full-text guidelines for definition of major risk factors.

19 Ένας παράγοντας κινδύνου αρκεί

20 ΟΤΑΝ ΤΑ ΔΕΔΟΜΕΝΑ ΕΠΙΔΕΧΟΝΤΑΙ ΠΟΛΛΑΠΛΩΝ ΑΝΑΓΝΩΣΕΩΝ

21 NON ICD deaths = 17/143 (9 yrs)? ICD deaths = 2/125 (3 yrs)? (Β) Αφαιρουμένων των πρώιμων θανάτων Viskin S, JCE 2003? (C) Αφαιρουμένων των αςθενών με παρακολούθηςη <6 έτη

22 Η ςυγκοπή ςε αςθενείσ με LQTS ΔΕΝ οφείλεται πάντα ςε TdP

23

24 Implantable Cardioverter-Defibrillators? I IIaIIbIII I IIaIIbIII I IIaIIbIII ICD implantation is reasonable for nonhospitalized patients awaiting transplantation. ICD implantation is reasonable for patients with Brugada syndrome who have had syncope. ICD implantation is reasonable for patients with Brugada syndrome who have documented VT that has not resulted in cardiac arrest.? I IIaIIbIII I IIaIIbIII ICD implantation is reasonable for patients with catecholaminergic polymorphic VT who have syncope and/or documented sustained VT while receiving beta blockers. ICD implantation is reasonable for patients with cardiac sarcoidosis, giant cell myocarditis, or Chagas disease. All primary SCD prevention ICD recommendations apply only to patients who are receiving optimal medical therapy and have reasonable expectation of survival with good functional capacity for more than 1 year.

25 An Entirely Subcutaneous Implantable Cardioverter Defibrillator Four Configurations of a Subcutaneous Implantable Cardioverter Defibrillator Bardy GH, et al. N Engl J Med May 12. [Epub ahead of print]

26 Ο ΑΙΦΝΙΔΙΟ ΘΑΝΑΣΟ ΔΕΝ ΠΡΟΛΑΜΒΑΝΕΣΑΙ ΠΑΝΣΑ ΑΠΟ ΣΟΤ ΑΠΙΝΙΔΩΣΕ