Kardiologie

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Acute Cardiovascular Care

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Acute Cardiovascular Care

Acute Cardiovascular Care:

Intraaortic balloon support for myocardial
infarction with cardiogenic shock*
Holger Thiele, MD; on behalf of the IABP-SHOCK II Trial Investigators
Universität Leipzig, Germany

Approximately 5–10% of patients after an acute myocardial

infarction present with cardiogenic shock. In Europe approxi-
mately, 60,000 to 70,000 patients present with cardiogenic
shock each year. In the last decade the mortality of cardio-
genic shock patients could be reduced mainly by early revas-
cularization. Nevertheless, mortality of these patients is still
extremely high with approximately half of the patients dying
within the first 30 days.

Since 1968 intraaortic balloon counterpulsation is used to sup-

port the failing heart in cardiogenic shock. This intraaortic
balloon pump (IABP) is the most widely used support device
in cardiogenic shock and since its introduction in 1968 the
IABP has been used in several million people. However, cur-
rently there is only limited proof of evidence that such an
IABP, one of the oldest medical products in cardiology, is ben-
eficial for the patient. There are only some registry studies and
also some trials which have shown that the IABP can improve
the blood pressure and also the perfusion of the coronary arter-
ies. Based on these studies, international guidelines recom-
mended using an IABP in patients with cardiogenic shock
with a class IB in the American and class IC in the European
guidelines. However, because cardiologists are not entirely
convinced by the device it is currently only used in 25–40% of
shock patients. Figure 1. Participating centres in Germany.

Therefore, the IABP-SHOCK II trial was started and it aimed

to show that the IABP can improve mortality if used in con-
junction with optimal medical therapy and early revascular- Patients with cardiogenic shock were enrolled in 37 centres in
ization. Germany (see Figure 1) within the last 2 and half years. This
trial was a German multicenter trial which was led be the lead
In this IABP-SHOCK II trial altogether 600 patients were ran- investigator Professor Dr. Holger Thiele, from the University
domly assigned to either support with the IABP or conven- of Leipzig – Heart Centre in Germany. The hypothesis of the
tional optimal medical treatment alone. With 600 included lead investigators was that the IABP could reduce mortality
patients the IABP-SHOCK II trial is currently the largest trial within 30 days.
in cardiogenic shock that has been performed, so far. Because
of its importance the trial was supported by the German Against the initial assumption, there was no reduction in 30-
Research Foundation, the German Heart Research Founda- day mortality in the IABP group in comparison to a group
tion, the German Cardiac Society, the “Arbeitsgemeinschaft without IABP treatment. Several subgroups were also evalu-
Leitende Kardiologische Krankenhausärzte”, and also partly ated and there was no clear benefit for any of the subgroups
funded by unrestricted grants from Maquet Cardiopulmonary studied. The IABP could also not show an improvement in
AG, Hirrlingen, Germany and Teleflex Medical, Everett, MA, blood pressure, a reduction in the length of treatment at the in-
USA. tensive care unit or in the length or the dose of drugs for the
support of the heart. Also on organ perfusion and tissue hy-
poxemia as measured by serial serum lactate measurements
there were no improvements with the IABP in comparison to
* Nachdruck aus http://www.escardio.org/communities/ACCA/publications/top-sto-
ries/Pages/intraaortic-balloon-support-cardiogenic-shock.aspx – 1. ACCA Newsletter
the control group. On the other hand, the trial results showed
der European Society of Cardiology, TOP Story, mit freundlicher Genehmigung von that the IABP did not induce complications. It was a safe de-
E. Delaveau, ACCA Administrator der ESC. vice.

62 J KARDIOL 2014; 21 (1–2)

For personal use only. Not to be reproduced without permission of Krause & Pachernegg GmbH.
 Acute Cardiovascular Care

In conclusion, the IABP-SHOCK II trial is the largest clinical In the recent metanalysis of Sjauw et al. [7], 3 out of 4 groups
trial in cardiogenic shock ever perwformed. The current trial of patients with STEMI and CS showed favourable results
could not show a benefit for the currently most widely used with IABP: patients treated with thrombolysis, patients with-
mechanical supporting device in cardiogenic shock. out reperfusion therapy and the overall group. As the primary
PCI group is concerned, in which no benefit was shown, it is
Correspondence: well possible that confounding factors have curtailed a possi-
Prof. Dr. med. Holger Thiele ble IABP beneficial effect: the study was not a randomized
Universität Leipzig – Herzzentrum, controlled trial (RCT) and it is not possible to exclude that the
Klinik für Innere Medizin/Kardiologie worse patients have been assigned to primary PCI treatment.
D-04289 Leipzig, Strümpellstraße 39
E-Mail: [email protected] Even in the latest RCT on AMI patients with CS (IABP-
SHOCK II trial) [8], the group randomized to IABP support
presented an absolute risk reduction of death at 30 days of
1.4% (RRR 4.1%), without any increase in complications
Pro Comment by Prof. Marco Tubaro, MD FESC, (major bleeding, peripheral ischaemia, stroke, sepsis). More-
San Filippo Neri Hospital, Rome, Italy over, being the IABP-SHOCK II population a group with CS
In many studies, intra-aortic balloon pumping (IABP) showed at moderate risk (40% global mortality at 30 days), it may well
to improve the haemodynamic parameters in patients with be possible that better results could be achieved in higher risk
acute myocardial infarction (AMI) and cardiogenic shock cohorts.
(CS): cardiac index and mean arterial pressure increased and
systemic vascular resistance decreased with IABP [1]. Com- Finally, in comparison with a left ventricular assist device
plete reversal of systemic hypoperfusion with IABP was (LVAD) like the Tandem Heart, IABP presented the same
linked to mortality at 30 days and 1 year. Prophylactic IABP mortality rate, with a reduced incidence of severe bleeding
can prevent reocclusion of the infarct-related artery and im- and limb ischaemia [1].
prove overall clinical outcome, without an increase of major
bleedings. In 1999, the AHA STEMI guidelines gave a class I The current STEMI guidelines give to IABP in STEMI pa-
indication for IABP in CS. tients with CS a class IIaB indication in USA and a class IIbB
indication in Europe. Even if a reduction of mortality has not
As mortality is concerned, already in the year 2000 the been demonstrated with IABP in association with primary
SHOCK Trial Registry demonstrated that a wide application PCI, the bulk of evidence and the everyday clinical practice
of IABP (86% of the patients) and of an invasive strategy re- are in favour of the use of IABP as haemodynamic support in
duced significantly 6-month and 1-year mortality rates [2]. patients with AMI and CS non immediately responsive to vol-
With thrombolytic therapy, IABP consistently showed a siner- ume expansion and inotropic stimulation. The same use of
gistic effect, both in the SHOCK Registry and in the data from IABP in case of AMI mechanical complications as a bridge to
the National Registry of Myocardial Infarction (NRMI)-2 [3]. intervention is clearly indicated.
The Benchmark Registry [4] confirmed the synergistic effect
of IABP and reperfusion, with a reduced mortality with PCI
(18.8%) or CABG (19.2%), in comparison with medical ther-
apy (33.2%). References: pulsation and infact size in patients with
acute anteriore myocardial infarction without
1. Cheng JM, den Uil CA, Hoeks SE, van der shock. The CRISP AMI randomized trial.
Ent M, Jewbali LSD, et al. Percu-taneous left JAMA 2011; 306: 1329–37.
IABP can be particularly useful in hospitals without primary ventricular assist devices vs. intra-aortic bal-
loon pump counterpulsation for treatment of 6. Perera D, Stables R, Clayton T, De Silva K,
PCI facilities, to improve cardiac haemodynamics during pa- Lumley M, et al. Long-term mortality data
cardiogenic shock: a meta-analysis of con-
tients’ transfer to a tertiary care cardiac centre. In case of a trolled trials. Eur Heart J 2009; 30: 2102–8. from the balloon-pump assisted coronary in-
tervention study (BCIS-1): a randomized con-
long transfer time, a strategy of thrombolysis and IABP, fol- 2. Sanborn TA, Sleeper LA, Bates ER, Jacobs trolled trial of elective balloon counterpulsa-
AK, Boland J, et al., for the SHOCH Investiga-
lowed by an immediate transfer for PCI/CABG, may be ap- tors. J Am Coll Cardiol 2000; 36: 1123–9.
tion during high-risk PCI. Circulation 2013;
127: 207–12.
propriate. 3. Barron HV, Every NR, Parsons LS, Angeja B, 7. Siauw KD, Engstrom AE, Vis MM, van der
Goldberg RJ, et al., for the Investigators in Schaaf RJ, Baan Jr J, et al. A systematic re-
the National Registry of Myocardial Infarction view and meta-analysis of intraaortic balloon
IABP was studied also in patients with AMI without CS: in the 2. Am Heart J 2001; 141: 933–9. pump therapy in ST-elevation myocardial in-
CRISP-AMI trial, even if the infarct size (evaluated with car- 4. Ferguson III JJ, Cohen M, Freedman RJ, farction: should we change the guidelines?
diac magnetic resonance) was not reduced by IABP applica- Stone GW, Miller MF, et al. The current prac- Eur Heart J 2009; 30: 459–68.
tice of intra-aortic balloon counterpulsation: 8. Thiele H, Zeymer U, Neumann F-J, Ferenc
tion, both mortality and combined end-point at 6 months were results from the Benchmark Registry J Am M, Olbrich H-G, et al., for the IABP-SHOCK II
reduced in patients with anterior AMI treated with IABP [5]. Coll Cardiol 2001; 38: 1456–2. trial investigators. Intraaortic balloon support
About 8.5% of patients in the study crossed over from the non- 5. Patel MR, Smalling RW, Thiele H, Barnhart for myocardial infarction with cardiogenic
HX, Zhou Y, et al. Intra-aortic balloon counter- shock. N Engl J Med 2012; 367: 11287–96.
IABP group to the IABP group: this could support a “stand-
by” strategy of IABP application only when needed, in com-
parison with a routine IABP use.
Con Comment by Prof. Uwe Zeymer, Klinikum
Moreover, IABP showed very good results in BCIS-1 trial [6] Ludwigshafen, Germany
on patients with ischaemic cardiomyopathy and severe CAD. Early revascularization therapy has been shown to improve
The 6-month mortality risk showed a 34% relative risk reduc- outcome of patients with acute myocardial infarction compli-
tion (RRR) with IABP (HR 0.66; 95%-CI: 0.44–0.98). cated by cardiogenic shock, but mortality in these patients re-

J KARDIOL 2014; 21 (1–2) 63

Acute Cardiovascular Care

mains high. Current ESC guidelines recommend the use of junct to primary PCI was associated with an adverse outcome.
IABP in patients with cardiogenic shock with an IIb indication In experimental models and human experience IABP in-
[1]. In clinical practice in Europe the utilization rate of IABP creased myocardial perfusion and improved hemodynamics.
is low (15–30%) [2]. However, one reason for the overall low But these factors seem not to be crucial in patients with early
utilization rate of IABP might be that interventionalists are not PCI for cardiogenic shock. The multi-organ distress syndrome
fully convinced about the beneficial effect of IABP on top of induced by the shock seems to play a more important role
early revascularization therapy. This scepticism is supported once successful reperfusion has been achieved by PCI or
by a recent randomized trial, the IABP-Shock II study [3]. The CABG. IABP clearly is not beneficial in this respect.
largest randomized trial in patients with cardiogenic shock so
far found no benefit of the IABP in patients with STEMI com- What indications remain for IABP. With any doubt the use is
plicated by cardiogenic shock treated with primary PCI. Al- indicated in patients with mechanical complications as bridge
though IABP use was safe and not associated with an increase to surgery. It might be beneficial in combination with fibrino-
in complications such as sepsis, vascular complications or lysis. However, since fibrinolysis is only recommended if pri-
bleedings neither mortality nor any secondary endpoints were mary PCI is not available, one can hardly imagine a situation
improved with IABP use. Secondary endpoints included hemo- where PCI is not available but only an IABP. The finding the
dynamic parameters (blood pressure and heart rate) pre and younger patients might benefit from IABP in the IABP-Shock
post revascularization, serum lactate levels measured every 8 h II trial [3] is hypothesis generating, and should be replicated in
for 48 h, inflammatory markers, Simplified Acute Physiology a dedicated prospective trial. So far IABP might be considered
Score-II (SAPS-II) measured daily during intensive care treat- in selected younger patients without hemodynamic improve-
ment, and serial creatinine-level and creatinine-clearance us- ment after successful revascularization.
ing the Cockcroft-Gault-formula. Furthermore, process of
care outcomes such as time to hemodynamic stabilization,
dose and duration of catecholamine therapy, requirement for
References: aortic balloon pump therapy in ST-elevation
renal replacement therapy, length of intensive care unit stay, myocardial infarction: should we change the
requirement and length of mechanical ventilation, and re- 1. Steg PG, James S, Atar D, et al. ESC guide- guidelines? Eur Heart J 2009; 30: 459–68.
lines for the management of acute myocardial
quirement for active (percutaneous or surgical) left ventricular infarction in patients presenting with ST-seg- 5. Barron HV, Every NR, Parsons LS, et al. The
assist device implantation or heart transplantation were as- ment elevation. Eur Heart J 2012; 33: 2569– use of intra-aortic balloon counterpulsation in
619. patients with cardiogenic shock complicating
sessed and did not differ between the two groups. Therefore in acute myocardial infarction: data from the
highly experienced centers the use of IABP was safe but did 2. Zeymer U, Bauer T, Hamm CW, e al. Use National Registry of Myocardial Infarction 2.
and impact of intra-aortic balloon pump on Am Heart J 2001; 114: 933–9.
not improve outcome. The small 1.4% difference in mortality mortality in patients with acute myocardial
infarction complicated by cardiogenic shock. 6. Stone GW, Ohman EM, Miller MF, et al.
in favour of IABP was far from reaching statistical signifi- Results of the EuroHeart Survey on PCI. Contemporary utilization and outcomes of in-
cance and given the negative results in all secondary endpoints EurIntervention 2011; 7: 437–41. tra-aortic balloon counterpulsation in acute
myocardial infarction: the benchmark registry.
it is highly unlikely that 6- or 12 months results will show a 3. Thiele H, Zeymer U, Neumann F-J, et al. In- J Am Coll Cardiol 2003; 41: 1940–5.
significant benefit for IABP. traaortic balloon support for myocar-dial in-
7. Zeymer U, Hochadel M, Hauptmann KH, et
farction with cardiogenic shock. N Engl J
Med 2012; 367: 11287–96. al. Intra aortic balloon pump in patients with
acute myocardial infarction complicated by
The results are supported by a recent meta-analysis [4] and 4. Siauw KD, Engstrom AE, Vis MM, et al. A cardiogenic shock. Results of the ALKK-PCI
finding from registries [2, 5–7]. If anything than IABP as ad- systematic review and meta-analysis of intra- Registry. Clin Res Cardiol 2013; 102: 223–7.

64 J KARDIOL 2014; 21 (1–2)

 Acute Cardiovascular Care

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J KARDIOL 2014; 21 (1–2) 65

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