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ICD FOR EVERY ONE? INADEQUATE SCIENTIFIC EVIDENCE DEV PAHLAJANI MD,FACC,FSCAI HOD INTERVENTIONAL CARDIOLOGY  BREACH CANDY HOSPITAL MUMBAI
TODAY’S MENU 58 YEARS OLD GENTLEMAN ANTERIOR WALL MI  6MONTHS LVEF 0.25
WHY NO ICD? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
TODAY’S MENU ICD  FOR PRIMARY PREVENTION
POTENTIAL RISKS OF ICD!!! ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
TRIALS FOR ICD ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
 
Kaplan–Meier Estimates of the Probability of Survival in the Group Assigned  to Receive an Implantable Defibrillator and the Group Assigned to  Receive Conventional Medical Therapy. Moss AJ et al. N Engl J Med 2002;346:877-883.
MADIT II-PROTOCOL ,[object Object],[object Object]
Supported by a research grant from Guidant, St. Paul, Minn., to the University of Rochester School of Medicine and Dentistry. Drs. Cannom, Daubert, and Higgins have given lectures sponsored by Guidant. PATIENTS DID NOT PAY FOR THE ICD DEVICE WAS PAID FOR BY GUIDANT
 
Daubert, J. P. et al. J Am Coll Cardiol 2008;51:1357-1365 Survival Free of Inappropriate Shock/Therapy
SIGNIFICANCE OF INAPPROPRIATE SHOCK ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Consequences of (Mal)function: Proarrhythmia From Local Lead Effects?   SLS sequence leads to induction of VTs Many of induced VTs originate from defib.electrode site(EP Proven)
 
MADIT II WISDOM AFTER 6 YRS.
Multivariate Proportional Hazards Regression Model: Risk of All-Cause Mortality in the Conventional Therapy Group for Selected Risk Factors Risk Factor HR 95% Confidence Interval p Value NYHA functional class >II 1.87 1.23–2.86 0.004 Atrial fibrillation 1.87 1.05–3.22 0.034 QRS >120 ms 1.65 1.08–2.51 0.020 Age >70 yrs 1.57 1.02–2.41 0.042 BUN >26 mg/dl (and <50 mg/dl) 1.56 1.00–2.42 0.048
Goldenberg, I. et al. J Am Coll Cardiol 2008;51:288-296 Risk stratification ICD vs. Conventional- Probability of Survival in Patients With Risk Scores 1, 2, and >=3
Goldenberg, I. et al. J Am Coll Cardiol 2008;51:288-296 Risk stratification ICD vs. Conventional- Probability of Survival in VHR Patients
Goldenberg, I. et al. J Am Coll Cardiol 2008;51:288-296 U-Shaped Curve for ICD Efficacy
MADIT II LATE WISDOM ,[object Object]
DINAMIT PROTOCOL ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Kaplan–Meier Estimates of the Cumulative Risk of Death from Any Cause. Hohnloser SH et al. N Engl J Med 2004;351:2481-2488.
Mortality Rates. Hohnloser SH et al. N Engl J Med 2004;351:2481-2488.
Infrequent physician use of implantable cardioverter-defibrillators risks patient safety-New York state residents undergoing ICD implantation Stephen Lyman ,  Art Sedrakyan ,  Huong Do ,  Renee Razzano ,  Alvin I ushlin 2 Heart  2011;97:1655-1660
[object Object],38,992 ,[object Object],(73.4%) ,[object Object],(11.0%) ,[object Object],6439 (16.5%)  ,[object Object],1093 (2.8%) ,[object Object],(RR=1.8,  95% CI 1.3 to 2.4) ,[object Object],11.2% vs. 2.1% (RR=4.7,  95% CI 3.3 to 6.8)
Clinical Characteristics of the 1232 Patients. Moss AJ et al. N Engl J Med 2002;346:877-883.
[object Object],[object Object],[object Object]
TAKE HOME MESSAGE ,[object Object],[object Object],[object Object],[object Object]
[object Object]

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ICD controversy

  • 1. ICD FOR EVERY ONE? INADEQUATE SCIENTIFIC EVIDENCE DEV PAHLAJANI MD,FACC,FSCAI HOD INTERVENTIONAL CARDIOLOGY BREACH CANDY HOSPITAL MUMBAI
  • 2. TODAY’S MENU 58 YEARS OLD GENTLEMAN ANTERIOR WALL MI 6MONTHS LVEF 0.25
  • 3.
  • 4. TODAY’S MENU ICD FOR PRIMARY PREVENTION
  • 5.
  • 6.
  • 7.  
  • 8. Kaplan–Meier Estimates of the Probability of Survival in the Group Assigned to Receive an Implantable Defibrillator and the Group Assigned to Receive Conventional Medical Therapy. Moss AJ et al. N Engl J Med 2002;346:877-883.
  • 9.
  • 10. Supported by a research grant from Guidant, St. Paul, Minn., to the University of Rochester School of Medicine and Dentistry. Drs. Cannom, Daubert, and Higgins have given lectures sponsored by Guidant. PATIENTS DID NOT PAY FOR THE ICD DEVICE WAS PAID FOR BY GUIDANT
  • 11.  
  • 12. Daubert, J. P. et al. J Am Coll Cardiol 2008;51:1357-1365 Survival Free of Inappropriate Shock/Therapy
  • 13.
  • 14. Consequences of (Mal)function: Proarrhythmia From Local Lead Effects? SLS sequence leads to induction of VTs Many of induced VTs originate from defib.electrode site(EP Proven)
  • 15.  
  • 16. MADIT II WISDOM AFTER 6 YRS.
  • 17. Multivariate Proportional Hazards Regression Model: Risk of All-Cause Mortality in the Conventional Therapy Group for Selected Risk Factors Risk Factor HR 95% Confidence Interval p Value NYHA functional class >II 1.87 1.23–2.86 0.004 Atrial fibrillation 1.87 1.05–3.22 0.034 QRS >120 ms 1.65 1.08–2.51 0.020 Age >70 yrs 1.57 1.02–2.41 0.042 BUN >26 mg/dl (and <50 mg/dl) 1.56 1.00–2.42 0.048
  • 18. Goldenberg, I. et al. J Am Coll Cardiol 2008;51:288-296 Risk stratification ICD vs. Conventional- Probability of Survival in Patients With Risk Scores 1, 2, and >=3
  • 19. Goldenberg, I. et al. J Am Coll Cardiol 2008;51:288-296 Risk stratification ICD vs. Conventional- Probability of Survival in VHR Patients
  • 20. Goldenberg, I. et al. J Am Coll Cardiol 2008;51:288-296 U-Shaped Curve for ICD Efficacy
  • 21.
  • 22.
  • 23. Kaplan–Meier Estimates of the Cumulative Risk of Death from Any Cause. Hohnloser SH et al. N Engl J Med 2004;351:2481-2488.
  • 24. Mortality Rates. Hohnloser SH et al. N Engl J Med 2004;351:2481-2488.
  • 25. Infrequent physician use of implantable cardioverter-defibrillators risks patient safety-New York state residents undergoing ICD implantation Stephen Lyman ,  Art Sedrakyan ,  Huong Do ,  Renee Razzano ,  Alvin I ushlin 2 Heart  2011;97:1655-1660
  • 26.
  • 27. Clinical Characteristics of the 1232 Patients. Moss AJ et al. N Engl J Med 2002;346:877-883.
  • 28.
  • 29.
  • 30.

Notas del editor

  1. Figure 2. Kaplan–Meier Estimates of the Probability of Survival in the Group Assigned to Receive an Implantable Defibrillator and the Group Assigned to Receive Conventional Medical Therapy. The difference in survival between the two groups was significant (nominal P=0.007, by the log-rank test). Figure 3. Hazard Ratios and 95 Percent Confidence Intervals for Death from Any Cause in the Defibrillator Group as Compared with the Group Assigned to Receive Conventional Medical Therapy, According to Selected Clinical Characteristics. The hazard ratios in the various subgroups were similar, with no statistically significant interactions. The dotted vertical line represents the results for the entire study (nominal hazard ratio, 0.66, without adjustment for the stopping rule). The horizontal lines indicate nominal 95 percent confidence intervals. LVEF denotes left ventricular ejection fraction, and NYHA New York Heart Association.
  2. Figure 1. Kaplan–Meier Estimates of the Cumulative Risk of Death from Any Cause, According to Study Group. ICD denotes implantable cardioverter–defibrillator.