Module 3 ICD Indications and Clinical Studies ACCAHA
- Slides: 25
Module 3: ICD Indications and Clinical Studies
ACC/AHA Indications – Class I – Conditions for which there is evidence and/or general agreement that a pacemaker is beneficial – Class II – Conditions for which there is conflicting evidence about the benefits of a pacemaker Class IIa – Weight of evidence/opinion in favor of benefits Class IIb – Benefits are less well established by evidence/opinion – Class III – Conditions for which there is evidence and/or general agreement that a pacemaker is not useful/effective and in some cases may be harmful 2 Document identifier
Leading Causes of Death in the US 0% 5% Source: Sudden Cardiac Arrest Foundation 3 Document identifier 10% 15% 20% 25%
Arrhythmic Cause of Sudden Cardiac Arrest 12% Other Cardiac Cause 88% Arrhythmic Cause 4 Albert CM. Circulation. 2003; 107: 2096 -2101 Document identifier .
Underlying Arrhythmias of Sudden Cardiac Arrest Torsades de Pointes 13% Bradycardia 17% VT 62% 5 Bayés de Luna A. Am Heart J. 1989; 117: 151 -159. Document identifier Primary VF 8%
Indications: Secondary vs. Primary Prevention ICD implant Indications Secondary prevention ICD implantation improves survival in patients with a history of life-threatening ventricular arrhythmia. Primary Prevention ICD implantation also improves survival as primary prophylaxis against Sudden Cardiac Death in patients at high risk for ventricular tachyarrhythmias. 6 Document identifier
Secondary Prevention Indication Rules § Rule #1 – Survival of SCD episode (not due to reversible cause) § Rule #2 – VT or VF induced at EP study when drugs are ineffective § Rule #3 – NSVT with CAD/prior MI that is not suppressible by antiarrhythmic therapy 7 Document identifier
ICD Trials: Secondary Prevention AVID: Antiarrhythmics Versus Implantable Defibrillators CASH: The Cardiac Arrest Study Hamburg CIDS: The Canadian Implantable Defibrillator Study 8 Document identifier
AVID Mortality Reduction ICD vs. Antiarrhythmic Drug History of VF, VT with syncope or sustained VT with EF<40% Mortality reduction with ICD 1 year: 39% 2 years: 27% 3 years: 31% NEJM 1997; 337: 1576 -1583 9 Document identifier
CASH 24% Mortality Reduction with ICD Survivors of cardiac arrest secondary to sustained ventricular arrhythmia 10 Circulation. 2000; 102: 748 -754 Document identifier
CIDS 20% Mortality reduction with ICD CIDs substantiated the efficacy of ICD over Amiodarone as seen in AVID 11 Document identifier Circulation 2000 101: 1297 -1302
Secondary Prevention Summary % Mortality Reduction Overall Death 100 90 80 70 60 50 40 30 20 10 0 2 3 12 Document identifier 61 56 31 AVID at 3 Years 1 Arrhythmic Death 28 CASH at 3 Years The AVID Investigators. NEJM. 1997; 337: 1576 -1583. Kuck K. Circ. 2000; 102: 748 -754. Connolly S. Circ. 2000; 101: 1297 -1302. 33 20 CIDS at 2 Years
Primary Prevention ICD Indications § Rule #1 – Left ventricular ejection fraction (LVEF) of 35% or less § Rule #2 – New York Heart Association class II or III heart failure OR – History of myocardial infarction (s/p 40 days) 13 § Rule #3 – Medically optimized Document identifier
ICD Trials: Primary Prevention CABG-Patch: Coronary Artery Bypass Graft Patch DEFINITE: Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation Trial DINAMIT: The Defibrillator in Acute Myocardial Infarction Trial MADIT I: Multicenter Automatic Defibrillator Implantation Trial I MADIT II: Multicenter Automatic Defibrillator Implantation Trial II SCD-He. FT: Sudden Cardiac Death in Heart Failure Trial 14 Document identifier
CABG-Patch Prophylactic use of ICD with patient at time of CABG NEJM 1997; 337: 1569 -1575 15 Document identifier
DEFINITE *NIDCM, LVEF <36% and PVC or NSVT (NIDCM = Non-ischemic dilated cardiac myopathy) 35% Reduction in All Cause Mortality 16 Document identifier NEJM 2004; 350: 2151 -8 20% Reduction in SCD from arrhythmia
DINAMIT 6 – 40 days post MI, LVEF ≤ 35% 17 Document identifier NEJM 2004; 351, 24
MADIT 55% Mortality Reduction NEJM 1996; 335 18 Document identifier
MADIT II 30% Mortality Reduction Post MI and LVD 19 Document identifier NEJM 2002; 346
SCD-He. FT 23% mortality reduction Primary prevention: ICM and NICM N Engl. J Med. 2005; 352: 225 -237. 23% Reduction in All Cause Mortality For ICD Therapy (p-value 0. 007) 20 Document identifier
The Details § 2, 521 patients followed for a minimum of 45. 5 months § Randomized for Amiodarone, placebo, or ICD § Significant reduction in all cause mortality over a placebo or Amiodarone by 23%. – Ischemic or nonischemic dilated cardiomyopathy – New York Heart Association (NYHA) class II and III heart failure – Ejection fraction (EF) ≤ 30% – No history of prior sustained ventricular tachycardia (VT)/VF 21 Document identifier
CMS: Centers for Medicare & Medicaid Services § Yes! We will pay for ICDs!! 22 Document identifier
% Mortality Reduction w/ ICD Rx Primary vs. Secondary Prevention 75 % 54 % 76 % 55 % 31 % Mortality Reduction w/ ICD Rx 27 months 56% 31% 2 39 months 23 33% 28% 20% 6 3 Years 7 3 Years 1 Moss AJ. N Engl J Med. 1996; 335: 1933 -40. 2 Buxton AE. N Engl J Med. 1999; 341: 1882 -90. 3 Moss AJ. N Engl J Med. 2002; 346: 877 -83 4 Moss AJ. Presented before ACC 51 st Annual Scientific Sessions, Late Breaking Clinical Trials, March 19, 2002. 5 The AVID Investigators. N Engl J Med. 1997; 337: 1576 -83. 6 Kuck K. Circ. 2000; 102: 748 -54. 7 Connolly S. Circ. 2000: 101: 1297 -1302. Document identifier 3, 4 20 months 59% 5 3 Years 61 % ICD mortality reductions in primary prevention trials are equal to or greater than those in secondary prevention trials.
ACC/AHA classifications based on studies Indication Class Supporting Studies Structural heart disease, sustained VT Class I AVID, CASH, CIDS Syncope of undetermined origin, inducible VT or VF at EPS Class I CIDS LVEF <35% due to prior MI, at least 40 days post-MI, NYHA Class II or III Class I SCD-He. FT LVEF ≤ 35%, NYHA Class II or III Class I SCD-He. FT LVEF ≤ 30% due to prior MI, at least 40 days post-MI Class I MADIT II LVEF <40% due to prior MI, inducible VT or VF at EPS Class I MADIT, MUSTT 25 Document identifier
New Directions § PAINFREE RX II: Pacing Fast VT Reduces Shock Therapies § EMPIRIC: Preventing Shocks After ICD Implantation by a Strategy of Standardized ICD Programming § PREPARE: Primary Prevention Parameters Evaluation trial of implantable cardioverter defibrillators to reduce patient morbidity § MADIT RIT: Strategic programming: – Standard – Delayed therapy – High rate detection 26 Document identifier
- Icd indications
- Defibrillator implant
- Icd indications
- Paradigm shift from women studies to gender studies
- C device module module 1
- Pit and fissure sealants indications and contraindications
- Non functional space maintainer
- Flat recumbent position
- Active space maintainer
- Indications of rpd
- Lma indications semiconscious
- Contraindications of fpd
- Colostomy irrigation indication
- Onlay indications and contraindications
- Contraindications of tooth extraction
- Absolute contraindications of exodontia
- Continuous passive motion indications and contraindications
- Indications of passive movement
- Geographical indication and appellation of origin
- Contraindications of paraffin wax
- Contraindications of uvr
- Open mouth technique for relining
- Contraindications for vaginal delivery
- Contraindications for joint mobilization
- Joint play grades
- Leonard brushing technique