Role Of ICD Post-MI Patients With Heart Failure
Time to Defibrillation
• Recognize cardiac arrest 1 min
• Activate emergency response 1 min
• Call hospital / ambulance 1 min
• Medical help arrives on scene 10 min
• Locate victim and shock 2 min
• Total Elapsed Time 15 min
Anil Saxena Director & Clinical Head Cardiac Pacing & Electrophysiology Fortis Escorts Heart Institute, New Delhi INDIA Role Of ICD Post-MI Patients With Heart Failure VT After MI: Anatomy of Scar Underlying Arrhythmia of Sudden Death 8% 13% 17% 62% Adapted from Bayés de Luna A. Am Heart J. 1989;117:151-159. VT Primary VF Torsades de Pointes Bradycardia Sudden Cardiac Death Sudden Cardiac Death The Chain Of Survival Time to Defibrillation • Recognize cardiac arrest 1 min • Activate emergency response 1 min • Call hospital / ambulance 1 min • Medical help arrives on scene 10 min • Locate victim and shock 2 min • Total Elapsed Time 15 min ICD: Placement Implantable Cardioverter Defibrillator MADIT II Trial Design • Status: Completed in 2001 • First trial to show the life-saving benefits of ICDs without requiring patients to have a documented history of abnormal heart rhythms Consent & Randomisation Documented Prior MI LVEF <30% ICD No ICD Follow-up @ 3 months Monitor Rx End Points Selection Enrolment Follow-up Results 31% reduction in the risk of death at any interval among patients in the defibrillator group as compared with patients in the conventional-therapy group The cumulative survival curves represent a decrease in death rates in the defibrillator group (95% confidence limits; P-value) of 12% at 1 year (27 to 40%), 28% at 2 years (4 to 46%), and 29% at 3 years (5 to 46%). Mortality over an average follow-up of 20 months • 34% relative reduction in the risk of death at any interval among patients with a defibrillator as compared with patients without an ICD • Number needed to treat (NNT) • 8 at 8 years • 17 at 2 years • Analysis showed sustained benefit with primary ICD therapy in the MADIT II study population No ICD (Conventional Therapy) ICD <0.001 0.66 (0.56-0.78) 62% 49% p-value Hazard Ratio (95% CI) Cumulative Probability of Mortality (n=1232) Mortality over an average of 7.6 years* post-enrollment Additional Results – MADIT II 8-Year Data *median Circ 2010; 122: 1265-1271 Indications for ICD Therapy Class I (Post MI) • ICD therapy is indicated in patients with previous MI and spontaneous sustained VT, whether hemodynamically stable or unstable (Level of Evidence: A) ❖ Prior MI ❖ Spontaneous sustained VT ❖ Hemodynamically stable or unstable Indications for ICD Therapy Class I (Post MI) • ICD therapy is recommended for patients with prior MI who are at least 40 days post-MI, have an LVEF less than 35%, are NYHA functional class II or III. (Level of Evidence: A) ❖ Prior MI, at least 40 days post MI ❖ LVEF <35% ❖ NYHA functional class II or III Indications for ICD Therapy Class I (Post MI) • ICD therapy is recommended for patients with prior MI who are at least 40 days post-MI, have an LVEF less than 30%, are NYHA functional class I (Level of Evidence: A) ❖ Prior MI, at least 40 days post MI ❖ LVEF <30% ❖ NYHA functional class I Indications for ICD Therapy Class I (Post MI) • 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 (Level of evidence B) ❖ Prior MI, Non-sustained VT ❖ LVEF <40% ❖ Inducible VF or sustained VT on EP study Indications for ICD Therapy Class I (Post MI) • ICD therapy is indicated in patients with syncope of undetermined origin with clinically relevant, hemodynamically significant sustained VT or VF induced at electrophysiological study (Level of Evidence: B) ❖ Prior MI, history of syncope ❖ LVEF - Any EF ❖ Hemodynamically unstable VT on EP study What Changes Could Be Done? • More inclusions by identifying clinical situations which cause SCD risk ❖ Less than 40 day Post MI patients with low EF • Less liberal guidelines by better risk stratification ❖ Primary prevention population (some may not be benefitting) Case • 54 year male presents with acute anterior MI • Has sustained VT at 36 hours, DC shock given • Revascularization NOT done/possible/available • LVEF 25% Secondary Prevention: CAD—VF or Hemodynamically Unstable VT Associated With Acute (<48 h) MI Single or Recurrent VF or Polymorphic VT With Acute (<48 Hours) MI Total revascularization completed No revascularization indicated Not amenable to revascularization Primary Prevention: Post-Acute MI (<40 Days), LVEF <40% ICD For Primary Prevention • Huge cost to society in view of large number of patients • Difficult to implement in emerging economies • Wrong to withhold a guideline directed therapy • Need to further stratify the primary prevention group to identify patients for ❖ Highest benefit of ICD ❖ Intermediate benefit of ICD ❖ Less or no benefit of ICD IMPROVE-SCA STUDY ❖ 4800 patients 100 centres global study ❖ Prior MI, at least 40 days post MI ❖ LVEF <35% ❖ NYHA functional class II or III Presyncope/ Syncope Freq VEBs NSVT EF<25% Sudden Cardiac Death Risk Factors • Left Ventricular Dysfunction • Ventricular Ectopic Activity, NSVT • Wide QRS Complex • Reduced HR Variability • Positive late potentials • Inducible VT on EP Study • T wave alternance • Heart Rate turbulence & Baroreflex Sensitivity Survival After Acute MI Bigger JT. Am J Cardiol. 1986;57:12B. 3 2 1 0 A B C D 0.4 0.6 0.8 1.0 S u rv iv o rs h ip N 536 113 80 37 EF 30% 30% <30% <30% VPD <10/hr 10/hr < 10/hr 10/hr 0.2 Yea r A B C D Years After Baseline SCD in Relation to Complexity of VPCs Ruberman W. Circulation. 1981;64(2):297-305. Years After Baseline 25 20 15 10 5 0 0 1 2 3 4 5 Sudden Coronary Deaths 20 15 10 5 0 0 1 2 3 4 5 Other Cardiac Deaths Runs a/o early VPC (202) Other complex VPC (260) Simple VPC only (433) No VPC (844) 25 C u m u la ti v e P ro b a b ili ty o f D e a th (a g e -a d ju s te d % ) Normal Heart Rate Variability Impaired Heart Rate Variability Conclusions • Post MI ICD implantation is a standard therapy in selected patients with increased risk of SCD • There is a need to redefine the indications to include certain clinical situations • There is need to further stratify primary prevention population according to SCD risk Thank You anil.saxena@hotmail.com
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