icd controversy
DESCRIPTION
ICD controversyTRANSCRIPT
ICD FOR EVERY ONE?INADEQUATE SCIENTIFIC
EVIDENCEDEV 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?• NO ARRHYTHMIA ON ECG• NO HOLTER• NO WIDENING OF QRS• NO SIGNAL AVERAGE ABNORMALITIES• NO HEART RATE VARIABILITY• NO EP GUIDANCE
TODAY’S MENU
ICD FOR PRIMARY
PREVENTION
POTENTIAL RISKS OF ICD!!!• INAPPROPRIATE SHOCKS LEADING TO NO
MORTALITY BENEFIT• PROCEDURAL COMPLICATIONS• INFECTION• DEVICE MALFUNCTION• MANUFATURER RECALL• PROARRHYTHMIA• IMPLANTS BY INADEQUTELY TRAINED
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
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• 1232 PATIENTS RANDOMISED 3:2 TO
ICD OR CONVENTIONAL MED.TREATMENT
• AVERAGE FOLLOW UP20 MONTHS RANGE 6 DAYS TO 53 MONTHS
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
• APPROPRIATE• DEATH DURING
FOLLOW UP-12.9%
• SUDDEN CARD.DEATH• 3.3%
• INAPPROPRIATE:
• 16.9%
4.9%
Consequences of (Mal)function:Proarrhythmia From Local Lead Effects?
SLS sequence leads to induction of VTsMany of induced VTs originate from defib.electrode site(EP Proven)
MADIT II WISDOM AFTER 6 YRS.
Risk Factor HR95% Confidence
Intervalp 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
Multivariate Proportional Hazards Regression Model: Risk of All-Cause Mortality in the Conventional Therapy Group for Selected Risk Factors
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
• 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
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
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 ushlin2
Heart 2011;97:1655-1660
Total number of ICD Implantations performed between
(1st Jan 1997 to 31st 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)
Clinical Characteristics of the 1232 Patients.
Moss AJ et al. N Engl J Med 2002;346:877-883.
“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
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
Thank You