DISCUSSION OVER IABP SHOCK II LONG TERM OUTCOMES PUBLICATION

1. Journal club
Dr Krishna Prasad

3. • Mortality in cardiogenic shock following acute myocardial infarction
40% to 60 %
• IABP is the most commonly used mechanical circulatory support
device
• IABP SHOCK II short and mid term results showed no mortality
benefit
• Based on this trial recommendation was downgraded from I to III B in
ESC and to Class IIb in ACC
• Long term results of IABP usage are lacking

4. Study design
• Open label, randomized, multicenter study done in Germany between
June 2009 and March 2012

5. Inclusion criteria
• Cardiogenic shock with planned early revascularization preferably by
PCI
• Cardiogenic shock is defined as
• SBP less than 90 mm of Hg for more than 30 minutes
• Catecholamines to maintain a systolic pressure of > 90 mm of Hg
• Signs of pulmonary congestion
• Imapired end organ perfusion
• Altered mental status
• Cold, clammy skin and extremities
• Oliguria with decreased urine output less than 30 ml per hour
• Serum lactate level higher than 2.0 mmol/l

6. Exclusion criteria
• Resuscitation > 30 minutes
• No intrinsic heart action
• Severe cerebral deficit
• Mechanical causes of cardiogenic shock
• Onset of shock > 12 hours
• Severe peripheral artery disease precluding IABP insertion
• Aortic regurgitation grade > 2
• > 90 years of age
• Shock of other cause
• Severe concomitant disease with a life expectancy of < 6 months

7. End points
• All cause mortality
• Reinfarction
• Revascularization by PCI or CABG
• Stroke
• ICD need as in previous trial
• 6 year follow up variables
• Symptoms of HF NYHA class
• Angina by CCS class
• EQ-5D-3 L index

8. • Mobility
• Self-care
• Usual activities
• Pain
• Discomfort
• Anxiety/depression
• Each of which can take 1 of 3 responses (no problems, some or moderate
problems, or extreme problems)
• EQ visual analogue scale from 0 to 100 with 100 indicating best health
status

15. Other findings
• In IABP group no difference in long term mortality between patients
who underwent IABP before and after revascularization (64.9 % vs
64.6%)
• Multivariate modelling revealed increasing age, history of stroke,
baseline arterial lactate, creatinine level, oliguria <30 ml/hr,
multivessel CAD, cold or clammy skin and extremities and LBBB at
admission independent risk factors for mortality
• IABP treatment was not predictive of survival

17. • Among the 6 years survivors n=197
• 82 % were in the NYHA I or II class (82% in the IABP and 82% in the control
group, p=1.00)
• 13% in IABP group and 25% in control group were in CCS class I or II
• No Difference in EQ 5 dimensions and EQ visual analogue scale

18. Discussion
• Mortality is high (2/3rd) at 6 years follow up (comparable to SHOCK
trial 46.7% at 30 days and 67.2% at 6 years)
• Long term results support the short term and mid term data
• IABP showed no benefit in cardiogenic shock and also in elective PCI
of high risk coronary with severe left ventricular dysfunction
• No specific improvement in markers of systemic inflammation,
arterial lactate, renal function, MAP, intensive unit care scores, or
doses of catecholamines supporting the pathophysiological aspects of
no mortality benefit

19. • Strengths of the trial Size, multocentre design, recruitement of high
risk real world cardiogenic shock population and near complete
clinical follow up
• Back drops – ack of blinding, less number of surgical patients cant be
generalizable to patietns undergoing immediate bypass surgery

20. Thanks
• IABP though appears to improve hemodynamics by increasing the
diastolic blood pressure and improving coronary perfusion and
decreasing afterload fails to show mortality benefit
• Guidelines ESC class III B for routine IABP in cardiogenic patients
• ACC class II b