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Transcript of sabari krishnan
JOURNAL CLUB
Sabari krishnan
INTRAAORTIC BALLOON SUPPORT FOR MYOCARDIAL
INFARCTION WITH CARDIOGENIC SHOCK
Holger Thiele, Uwe Zeyer, Franz-Josef Neumann, Miroslaw Ferenc, Hans-Georg Olbrich, Jörg
Hausleiter et al
The NEW ENGLAND JOURNAL of MEDICINE october 4,2012 vol.367 no.14
INTRODUCTION
IABP is a mechanical device that increases
myocardial oxygen perfusion while at the same
time increasing cardiac output
Increasing cardiac output increases coronary
blood flow and therefore myocardial oxygen
delivery
Consists of a cylindrical polythene balloon that sits in aorta, approximately 2cm from the left subclavian artery and counter pulsates
Actively deflates in systole, increasing forward blood flow by reducing after load. It actively inflates in diastole, increasing blood flow to the coronary arteries
These actions combine to decrease myocardial oxygen demand and increase myocardial oxygen supply
NEED OF THIS STUDY A meta-analysis that included only cohort studies
suggested that the use of an IABP is associated with a reduction by 11% in the risk of death.
In the recent (IABP-SHOCK) trial, which involved only 45 patients, no significant difference was observed with respect to the (APACHE II) score for severity of illness between patients assigned to IABP and those assigned to a control group that received standard care, although serial brain natriuretic peptide levels were significantly reduced in the balloon-pump group.
The IABP-SHOCK II trial was designed to test the hypothesis that IABP as compared with the best available medical therapy alone, results in a reduction in mortality among patients with acute myocardial infarction complicated by cardiogenic shock for whom early revascularization is planned
Inconclusive evidence might be one explanation for the current use of IABP in only 25 to 40% of patients with cardiogenic shock, despite the recommendations in the guidelines
METHODS TYPE OF STUDY
Randomized, prospective, open-label, multicenter trial,
Randomization
Internet-based program, with stratification according to center.
PERIOD-june16th,2009-march3,2012
ELIGIBLE CRITERIA Acute myocardial infarction (with or without ST segment elevation)
complicated by cardiogenic shock and if early revascularization (by means of PCI or CABG) was planned.
CARDIOGENIC SHOCK
Systolic blood pressure <90 mm hg for more than 30 minutes
Catecholamine's to maintain a systolic pressure >90 mm hg
Signs of pulmonary congestion and
Impaired end- organ perfusion. Altered mental status Cold, Clammy skin and extremities Oliguria with urine output of less than 30 ml per hour Serum lactate level higher than 2.0 mmol per liter
EXCLUSION CRITERIA Resuscitation for more than 30 minutes
Had no intrinsic heart action were in a coma with fixed
dilatation of pupils that was not induced by drugs
Had a mechanical cause of cardiogenic shock (e. g Ventricular
septal defect or papillary muscle rupture)
Had onset of shock more than 12 hours before screening
Older than 90 years of age
Shock as a result of a condition other than acute myocardial
infarction
Had severe concomitant disease associated with a life
expectancy of less than 6 months
Had a massive pulmonary embolism
Severe peripheral arterial disease precluding
insertion of an IABP or aortic regurgitation
greater than grade II in severity
790
600
301 299
OUTCOMES
NO SIGNIFICANT DIFFERENCE BETWEEN TWO GROUPS
DISCUSSION No immediate improvement in blood
pressure or heart rate between two groups.
Although positive effect of IABP on multiorgan
dysfunction at day 2 and 3, as assessed with
the use of the SAPS II, this effect was not
evident at day 4.
No significant effects on CRP level or serum
lactate level, which were assessed as measures
of inflammation and tissue oxygenation.
Studies showed IABP results in a hemodynamic benefit
as a result of afterload reduction and diastolic
augmentation with improvement in coronary perfusion.
However, the effects on cardiac output are modest
and might not be sufficient to reduce mortality.
In a recent, small, randomized trial, there were no
significant differences in cardiac power output, left
ventricular stroke-work index, or systemic
vascular resistance between patients assigned to
IABP and those assigned to a control group.
Use of IABP before coronary revascularization may
make the revascularization procedure safer by
improving left ventricular unloading.
However, in the current trial, there was no mortality
benefit in the subgroup of patients in whom the IABP
was inserted before the start of revascularization, as
compared with those in whom it was inserted after
revascularization.
In another recent randomized trial involving patients
with large anterior infarctions but without cardiogenic
shock, insertion of a balloon pump before PCI, as
compared with control treatment did not reduce the
infarct size.
LIMITATIONS
① Blinding was not possible because of the nature of the intervention..
② Hemodynamic measurements or assess laboratory inflammatory
markers other than blood pressure, heart rate, and c-reactive
protein levels, not done
③ The slightly lower mortality in trial — approximately 40%, as
compared with 42 to 48% in other randomized trials and registries
— might suggest that trial included a higher percentage of patients
with mild or moderately severe cardiogenic shock, a factor that
could preclude generalization of the results to patients with the
most severe forms of cardiogenic shock.
④ The negative overall result, cannot definitively rule out
a type II error;
⑤ No information about longer-term outcomes. To
minimize bias, use of a central randomization system,
and the members of the clinical events committee
were unaware of the group assignments.
CONCLUSION C O N T R O L L E D T R I A L O F I N T RA AO RT I C B A L LO O N P U M P
S U P P O RT I N PAT I E N T S W I T H C A R D I O G E N I C S H O C K
C O M P L I C AT I N G M YO C A R D I A L I N FA RC T I O N F O R W H O M
E A R LY R E VA S C U L A R I Z AT I O N A S C O M PA R E D W I T H
C O N V E N T I O N A L T H E RA PY , DID NOT REDUCE 30 -DAY
MORTAL ITY.
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