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ICD controversy

ICD controversy

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  • 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.
  • Figure 1. Kaplan–Meier Estimates of the Cumulative Risk of Death from Any Cause, According to Study Group. ICD denotes implantable cardioverter–defibrillator.

Transcript

  • 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. WHY NO ICD?
    • NO ARRHYTHMIA ON ECG
    • NO HOLTER
    • NO WIDENING OF QRS
    • NO SIGNAL AVERAGE ABNORMALITIES
    • NO HEART RATE VARIABILITY
    • NO EP GUIDANCE
  • 4. TODAY’S MENU ICD FOR PRIMARY PREVENTION
  • 5. POTENTIAL RISKS OF ICD!!!
    • INAPPROPRIATE SHOCKS LEADING TO NO MORTALITY BENEFIT
    • PROCEDURAL COMPLICATIONS
    • INFECTION
    • DEVICE MALFUNCTION
    • MANUFATURER RECALL
    • PROARRHYTHMIA
    • IMPLANTS BY INADEQUTELY TRAINED
  • 6. TRIALS FOR ICD
    • SECONDARY PREVENTION
    • AVID +VE
    • CIDS -VE
    • CASH -VE
    • MUSTT +VE
    • PRIMARY PREVENTION
    • MADIT I +VE XX
    • MADIT II +VE
    • DINAMIT -VE
    • CABG PATCH -VE
    • SCD –HeFT +VE
  • 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. MADIT II-PROTOCOL
    • 1232 PATIENTS RANDOMISED 3:2 TO ICD OR CONVENTIONAL MED.TREATMENT
    • AVERAGE FOLLOW UP20 MONTHS RANGE 6 DAYS TO 53 MONTHS
  • 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. SIGNIFICANCE OF INAPPROPRIATE SHOCK
    • APPROPRIATE
    • DEATH DURING FOLLOW UP-12.9%
    • SUDDEN CARD.DEATH
    • 3.3%
    • INAPPROPRIATE:
    • 16.9%
    • 4.9%
  • 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. MADIT II LATE WISDOM
    • Defibrillator therapy was associated with a 49% reduction in risk of death among patients with >1 risk factor whereas no ICD benefit was identified in patients with 0 risk factors and very high risk patients JACC 2008
  • 22. DINAMIT PROTOCOL
    • OPEN LABEL COMAPARISION OF ICD VS NO THERAPY-IDENTICAL CLINICAL VARIABLES
    • ICD- 342 PATIENTS
    • NO THERAPY 342 PATIENTS
    • 6-40 DAYS POST MI
    • LVEF <0.35
    • DEPRESSED HEART RATE VARIAB.OR ELEVATED AVG.24HOUR HEART RATE ON HOLTER
  • 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.
    • Total number of ICD Implantations performed between (1 st Jan 1997 to 31 st Dec 2006)
    38,992
    • Very-Low-volume operators who implanted one or fewer ICDs per year (<1 ICD/yr)
    (73.4%)
    • Implantations performed by very Low volume operators
    (11.0%)
    • Post ICD implantation complications
    6439 (16.5%)
    • Deaths within 90 days of implantation.
    1093 (2.8%)
    • Patients treated by very Low volume operators more likely to die compared to operators who frequently performed ICD implantation.
    (RR=1.8, 95% CI 1.3 to 2.4)
    • Patients experiencing cardiac complications operated by Low volume operators compared to operators who frequently performed ICD implantation.
    11.2% vs. 2.1% (RR=4.7, 95% CI 3.3 to 6.8)
  • 27. Clinical Characteristics of the 1232 Patients. Moss AJ et al. N Engl J Med 2002;346:877-883.
  • 28.
    • “ DON’T BE TRAPPED BY DOGMA-WHICH IS LIVING WITH THE RESULTS OF OTHER PEOPLE’S THINKING
    • DON’T LET THE NOISE OF OTHERS’ OPINIOS DROWN OUT YOUR OWN INNER VOICE”
    • STEVE JOBS
  • 29. TAKE HOME MESSAGE
    • EVIDENCE FOR ICD IMPLANTAION IN POST MI WITH LOW EF IS LACKING
    • TAKE A HOLISTIC APPROACH TO USE THIS VERY USEFUL DEVICE
    • DO NOT IMPLANT WITHOUT GAINING ADEQUATE TRANING
    • ANTICIPATE COMPLICATIONS
  • 30.
    • Thank You