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Meta-Analysis
. 2015 Mar 27;2015(3):CD007398.
doi: 10.1002/14651858.CD007398.pub3.

Intra-aortic balloon pump counterpulsation (IABP) for myocardial infarction complicated by cardiogenic shock

Susanne Unverzagt  1 , Michael Buerke, Antoinette de Waha, Johannes Haerting, Diana Pietzner, Melchior Seyfarth, Holger Thiele, Karl Werdan, Uwe Zeymer, Roland Prondzinsky
Affiliations
Meta-Analysis

Intra-aortic balloon pump counterpulsation (IABP) for myocardial infarction complicated by cardiogenic shock

Susanne Unverzagt et al. Cochrane Database Syst Rev. .

Abstract

Background: Intra-aortic balloon pump counterpulsation (IABP) is currently the most commonly used mechanical assist device for patients with cardiogenic shock due to acute myocardial infarction. Although there has been only limited evidence from randomised controlled trials, the previous guidelines of the American Heart Association/American College of Cardiology (AHA/ACC) and the European Society of Cardiology (ESC) strongly recommended the use of the IABP in patients with infarction-related cardiogenic shock on the basis of pathophysiological considerations, non-randomised trials and registry data. The recent guidelines downgraded the recommendation based on a meta-analysis which could only include non-randomised trials showing conflicting results. Up to now, there have been no guideline recommendations and no actual meta-analysis including the results of the large randomised multicentre IABP-SHOCK II Trial which showed no survival benefit with IABP support. This systematic review is an update of the review published in 2011.

Objectives: To evaluate, in terms of efficacy and safety, the effect of IABP versus non-IABP or other assist devices guideline compliant standard therapy on mortality and morbidity in patients with acute myocardial infarction complicated by cardiogenic shock.

Search methods: Searches of CENTRAL, MEDLINE (Ovid) and EMBASE (Ovid), LILACS, IndMed and KoreaMed, registers of ongoing trials and proceedings of conferences were updated in October 2013. Reference lists were scanned and experts in the field contacted to obtain further information. No language restrictions were applied.

Selection criteria: Randomised controlled trials on patients with acute myocardial infarction complicated by cardiogenic shock.

Data collection and analysis: Data collection and analysis were performed according to the published protocol. Individual patient data were provided for six trials and merged with aggregate data. Summary statistics for the primary endpoints were hazard ratios (HRs) and odds ratios (ORs) with 95% confidence intervals (CIs).

Main results: Seven eligible studies were identified from a total of 2314 references. One new study with 600 patients was added to the original review. Four trials compared IABP to standard treatment and three to other percutaneous left assist devices (LVAD). Data from a total of 790 patients with acute myocardial infarction and cardiogenic shock were included in the updated meta-analysis: 406 patients were treated with IABP and 384 patients served as controls; 339 patients were treated without assisting devices and 45 patients with other LVAD. The HR for all-cause 30-day mortality of 0.95 (95% CI 0.76 to 1.19) provided no evidence for a survival benefit. Different non-fatal cardiovascular events were reported in five trials. During hospitalisation, 11 and 4 out of 364 patients from the intervention groups suffered from reinfarction or stroke, respectively. Altogether 5 out of 363 patients from the control group suffered from reinfarction or stroke. Reocclusion was treated with subsequent re-revascularization in 6 out of 352 patients from the intervention group and 13 out of 353 patients of the control group. The high incidence of complications such as moderate and severe bleeding or infection in the control groups has to be attributed to interventions with other LVAD. Possible reasons for bias were more frequent in small studies with high cross-over rates, early stopping and the inclusion of patients with IABP at randomisation.

Authors' conclusions: Available evidence suggests that IABP may have a beneficial effect on some haemodynamic parameters. However, this did not result in survival benefits so there is no convincing randomised data to support the use of IABP in infarct-related cardiogenic shock.

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Conflict of interest statement

Roland Prondzinsky (principal investigator), Michael Buerke (study site), Karl Werdan (study site), Susanne Unverzagt (statistician) and Johannes Haerting (co‐investigator) were involved in the IABP SHOCK Trial (2003 to 2004) (Prondzinsky 2010)

Melchior Seyfarth (principal investigator) and Antoinette de Waha in Seyfarth 2008

Holger Thiele (principal investigator) in Thiele 2005

Holger Thiele (principal investigator and chair, steering committee, clinical endpoints committee, study site), Gerhard Schuler (steering committee, study site), Karl Werdan (steering committee, study site), Uwe Zeymer (steering committee, clinical endpoints committee, study site), Johannes Haerting (data safety and monitoring board), Antoinette de Waha (study site), Melchior Seyfarth (study site), Michael Buerke (study site), Roland Prondzinsky (study site) were involved in Thiele 2012

Judgements of inclusion criteria and risk of bias for these studies and interpretation of results were appraised by SU and RP, and in the case of Prondzinsky 2010 by HT.

Figures

1
1
Flow diagram update January 2013.
2
2
All‐cause mortality distribution of included studies on the basis of individual patient data
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
4
4
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
5
5
Funnel plot of comparison: IABP versus control, outcome: all‐cause 30‐day mortality distribution.
6
6
Forest plot of comparison: IABP versus control, outcome: all‐cause 30‐day mortality distribution.
1.1
1.1. Analysis
Comparison 1: IABP versus control, Outcome 1: All‐cause 30‐day mortality distribution
1.2
1.2. Analysis
Comparison 1: IABP versus control, Outcome 2: All‐cause mortality distribution
1.3
1.3. Analysis
Comparison 1: IABP versus control, Outcome 3: All‐cause in‐hospital mortality rates
1.4
1.4. Analysis
Comparison 1: IABP versus control, Outcome 4: All‐cause 30‐day mortality rates
1.5
1.5. Analysis
Comparison 1: IABP versus control, Outcome 5: All‐cause 6‐month mortality rates
1.6
1.6. Analysis
Comparison 1: IABP versus control, Outcome 6: All‐cause 12‐month mortality rates
1.7
1.7. Analysis
Comparison 1: IABP versus control, Outcome 7: Haemodynamics (CI) post intervention
1.8
1.8. Analysis
Comparison 1: IABP versus control, Outcome 8: Haemodynamics (MAP) post intervention
1.9
1.9. Analysis
Comparison 1: IABP versus control, Outcome 9: Haemodynamics (PCWP) post intervention
1.10
1.10. Analysis
Comparison 1: IABP versus control, Outcome 10: Length of hospital stay
See this image and copyright information in PMC

Update of

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