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