Intraaortic balloon pump therapy has now been studied for 30 years, in the context of no reperfusion, fibrinolysis, and primary pci. In the intraaortic balloon pump in cardiogenic shock 2 iabpshock ii trial, the so far largest randomized controlled clinical trial in cardiogenic shock, the use of iabp did not significantly reduce 30day mortality in comparison to control. This multicenter study downgraded the use of iabp in ami. Wartono from the division of cardiothoracic surgery, department of surgery. That was the case, for example, of the shock trial, upon which is based the. Cardiovascular interventions1 that discussed the impact of clinical trials iabp shock ii, bcis1, and crispami on intraaortic balloon pump use in the cath lab. Impella shows similar mortality rates in mi with cardiogenic shock. There was neither improvement in 30day mortality, nor 1year mortality, nor in any of the secondary outcomes eg. Iabpshock ii trial results time to bailout iabp in the. Intraaortic balloon pump in cardiogenic shock complicating acute myocardial infarction.
Patients with cardiogenic shock complicating acute myocardial infarction who were undergoing early revascularisation and optimum medical therapy were randomly assigned 1. Our results are similar to those reported on the iabpshock ii trial in which no. Acute myocardial infarction ami complicated by cardiogenic shock cs is one of the leading causes of death in patients hospitalized with ami, and it accounts for 41. Reviewing iabp use after recent clinical trials cath lab digest. The national centre of health statistics estimated that iabp was used in 42 000 patients in the. Iabp shock ii trial 2012 the link above points to the evenmoreinteresting 1year followup of the iabp shock ii patients. It is also important to note that the results of the iabpshock ii trial apply only to standard iabp technology. The trial, known as iabpshock ii, was presented on aug. The current metaanalysis was conducted in accordance with the prisma guidelines. The same is true in the impress trial, where 80% of patients had the device, whether impella or balloon pump, placed after pci. Intraaortic balloon counterpulsation basic principles. Intraaortic balloon counterpulsation in acute myocardial infarction complicated by cardiogenic shock iabpshock ii. The contraindications to iabp are summarized in table 2. The aim of this study was to evaluate outcomes associated with use of the impella.
Sixhundred patients with cardiogenic shock complicating ami were randomly assigned to either an intraaortic balloon counterpulsation group iabp group, 301 patients or a control group no iabp 299 patients. Thiele h1, zeymer u, neumann fj, ferenc m, olbrich hg, hausleiter j, richardt g, hennersdorf m, empen k, fuernau g, desch s, eitel i, hambrecht r, fuhrmann j, bohm m, ebelt h, schneider s, schuler g, werdan k. Cardiogenic shock cs is a clinical condition of inadequate tissueend organ perfusion due to cardiac dysfunction hypotension sbp 2. The iabpshock ii trial the largest trial ever performed in cardiogenic shock randomised 600 patients enrolled in 37 centres in germany. A new study appears to challenge the traditional assertion that. Divaka perera, matthew lumley, and nico pijls, recently wrote an editorial in circulation. Intraaortic balloon counterpulsation therapy has been the firstline strategy for patients requiring mechanical circulatory support for more than 40 years. Outcomes the primary outcome was allcause mortality at 30 days. It was for these reasons that the iabpshock ii trial was designed, aiming to show that the iabp can improve. The iabp shock ii trial failed to show that mechanical support with iabp improved outcomes in ami with cardiogenic shock. At 30 days, there was no significant difference in the primary outcome of mortality between iabp and controls. Intraaortic balloon pump iabp is the most widely used mechanical device for the treatment of ami 3, 4, since its introduction by kantrowitz and. The intraaortic balloon pump iabp was replaced by impella cp and, to a lesser extent, venoarterial membrane oxygenation following the neutral iabpshock ii trial. Apr 29, 2020 the hypothesis and design of the shock trial have been previously published.
External validation and comparison of the cardshock and iabp. The trial randomised postangio patients n 600 to either iabp or no iabp. Impella versus iabp in acute myocardial infarction. The hypothesis and design of the shock trial have been previously published.
Intraaortic balloon pump in cardiogenic shock ii american college. The balloon pump has been the flagship modality for treating cardiogenic shock in spite of scant evidence supporting its use. Intraaortic balloon pump iabpthe iabp has been used to provide counterpulsation therapy, either with or without inotropes, in patients with cardiogenic shock. Intraaortic balloon pump in cardiogenic shock complicating. Fewer patients received mcs after iabp shock ii, and patients receiving mcs in recent years had more compromised haemodynamics at the time of shock compared with earlier years. Intraaortic balloon counterpulsation basic principles and. Oct 04, 2012 intraaortic balloon support for myocardial infarction with cardiogenic shock.
In the only adequately powered randomized trial of iabp in cs secondary to myocardial infarctioniabpshock ii intraaortic balloon pump in cardiogenic shock ii trialshort and midterm followup data at 30 days and 1 year showed no survival benefit with iabp support in comparison to control, nor any benefit with respect to secondary. The iabpshock ii trial was a multicenter, openlabel, randomized study. More than 95% underwent primary pci with stent placement in 90%. The iabp shock ii trial was a randomised, openlabel, multicentre trial. Intraaortic balloon support for myocardial infarction with cardiogenic shock. Intraaortic balloon counterpulsation in acute myocardial. Thiele h, zeymer u, neumann fj, et al on behalf of the intraaortic balloon pump in cardiogenic shock ii iabpshock ii trial investigators.
Despite significant advancements in health technology and research, hospital mortality approaches 50%. Oct 28, 2012 the balloon pump has been the flagship modality for treating cardiogenic shock in spite of scant evidence supporting its use. The last chapter of the iabpshock ii study was the recently. Intra aortic balloon counterpulsation learning package. Pdf impella versus iabp in acute myocardial infarction. Sep 18, 2012 so why you would use an iabp, such a complicated, expensive and invasive machine that might help unload the heart in systole, and gives you a tiny 510 mmhg extra in diastole is beyond me the shock ii trial actually reports no changeimprovement in blood pressure in the iabp arm. Evidence for the use of iabp in mi and cardiogenic shock. Dr holger thiele university of leipzig, germany gives an overview of the randomized comparison of intraaortic balloon counterpulsation vs optimal medical therapy in addition to early. Objectives the aim of this study was to determine whether a new percutaneous mechanical circulatory support pmcs device impella cp, abiomed, danvers, massachusetts decreases 30day mortality when compared with an intraaortic balloon pump iabp in patients with severe shock complicating ami. They do not apply to axialflow pumps like the impella or the percutaneous heart pump php.
The main cause of cardiogenic shock was acute coronary syndrome, occurring in 62% of the patients. The iabpshock ii trial failed to show that mechanical support with iabp. It was for these reasons that the iabp shock ii trial was designed, aiming to show that the iabp can improve. Mar 04, 2020 the intraaortic balloon pump iabp was replaced by impella cp and, to a lesser extent, venoarterial membrane oxygenation following the neutral iabp shock ii trial.
In 20, following the publication of the iabp shock ii trial, the use of iabp was terminated and replaced by impella. The aim of our study was to assess the impact of iabp in unselected patients. Principles of intraaortic balloon pump counterpulsation murli krishna mbbs frca ffpmrca. Iabp offered no mortality benefits at 30 days in the 600patient iabp shock ii trial. The present study is a predefined substudy of the iabp. Percutaneous mechanical circulatory support versus intra. Impella versus iabp in acute myocardial infarction complicated by cardiogenic shock.
The iabpshock ii trial was a randomised, openlabel, multicentre trial. The effectiveness of intraaortic balloon pump for myocardial. Cardiovascular outcomes using intraaortic balloon pump in highrisk acute myocardial infarction with or without cardiogenic shock. All statistical analyses were performed using spss software, version 20. Iabpshock ii hotline esc final 082012 clinical trial results. A read is counted each time someone views a publication summary such as the title, abstract, and list of authors, clicks on a figure, or views or downloads the fulltext. In this randomised, multicentre trial, iabp support did not reduce 30 day or 12 month mortality in. Iabpshock ii trial 2012 the link above points to the evenmoreinteresting 1year followup of the iabpshockii patients.
Of course, we have to be careful about any nonrandomized analysis because of unmeasured confounders. Impact of intraaortic balloon pump on shortterm clinical outcomes. Intraaortic balloon pump therapy does not improve mortality in acute myocardial infarction in the populations studied in rcts, regardless of the presence or absence of cardiogenic shock. Intraaortic balloon counterpulsation in acute myocardial infarction complicated by cardiogenic shock iabp shock ii. In this trial, the use of iabp was compared with no iabp support in patients with infarction. The iabp shock ii trial was a multicenter, openlabel, randomized study. Solaci latin american society of interventional cardiology. The trial aimed to test the superiority of a strategy of early committed. So why you would use an iabp, such a complicated, expensive and invasive machine that might help unload the heart in systole, and gives you a tiny 510 mmhg extra in diastole is beyond me the shock ii trial actually reports no changeimprovement in blood pressure in the iabp arm. Reviewing iabp use after recent clinical trials cath lab.
External validation and comparison of the cardshock and. It is also important to note that the results of the iabp shock ii trial apply only to standard iabp technology. No survival benefit of balloon pump in ami with shock. Cardiogenic shock is the leading cause of death in patients with acute myocardial infarction. Intraaortic balloon pump fails to improve mortality rate. Weaning was achieved by a stepwise reduction of the amount of support provided by the pmcs device. Randomized clinical trials have not shown a hemodynamic or mortality benefit with iabp when compared with medical therapy. Patel, why write this editorial looking at iabp use and current clinical trial data. If you look at the iabpshock ii trial, the majority more than 80% of the patients that were supported with a balloon pump had the device placed after pci. Compared with acute coronary syndrome patients, nonacute coronary syndrome patients were younger and had a lower proportion of risk factors but higher rates of renal insufficiency. Randomized comparison of optimal medical therapy in. Thiele h, zeymer u, neumann fj, et al on behalf of the intraaortic balloon pump in cardiogenic shock ii iabp shock ii trial investigators. Iabp failed to reduce 30day mortality in patients with cardiogenic shock. We conducted a randomized trial to evaluate early revascularization in patients.
Jul 24, 2012 the trial, known as iabp shock ii, was presented on aug. The study was approved by national regulatory authorities. Intraaortic balloon pump in cardiogenic shock ii iabp. Duration of mechanical support was guided by the treating intensive care physician. Hoppe mentioned wether timing of iabpimplantation may have a certain. Intraaortic balloon support for myocardial infarction with. Key takeaways this substudy of the iabpshock ii trial sought to develop an easytouse, readily available risk prediction score for shortterm mortality in patients with amirelated cs undergoing pci. In 20, following the publication of the iabpshock ii trial, the. There were no significant differences between the two treatment groups with respect to short.
Iabpshock ii with dr holger thiele trial and pis youtube. In the largest randomised trial iabpshock ii, iabp support did not. Cardiovascular interventions 1 that discussed the impact of clinical trials iabpshock ii, bcis1, and crispami on intraaortic balloon pump use in the cath lab dr. P2269iabpshock ii risk score validation for cardiogenic shock. Following up on the 30 day and one year effect, the iabp shock ii trial long term outcomes showed there is not benefit to the use of intraaortic balloon counterpulsation in cardiogenic shock patients undergoing acute myocardial infarction. Final 12 month results of a randomised, openlabel trial. The goal of the trial was to evaluate treatment with intraaortic balloon counterpulsation iabp compared with no iabp among patients with acute myocardial infarction ami and cardiogenic shock. The role of intraaortic balloon counterpulsation iabp in cardiogenic shock is still a subject of intense debate despite the neutral results of the iabp shock ii trial intraaortic balloon pump in cardiogenic shock ii with subsequent downgrading in international guidelines. Longterm 6year outcome of the randomized iabpshock ii trial.
Objectives the iabpshock ii trial was designed to test the hypothesis that intraaortic balloon counterpulsation, 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 4. Divaka perera, matthew lumley, and nico pijls, recently wrote an edito rial in circulation. There are good reasons why earlier placement might be better. Randomized comparison of optimal medical therapy in addition.
Intraaortic balloon pump in cardiogenic shock ii iabpshock ii. Principles of intraaortic balloon pump counterpulsation. Iabp deployment in critical care home critical care and shock. No other percutaneous support device has proven superiority over iabps for treating patients with acute coronary. Intraaortic balloon counterpulsation in acute myocardial infarction. Fewer patients received mcs after iabpshock ii, and patients receiving mcs in recent years had more compromised haemodynamics at the time of shock compared with earlier years. Cardiovascular outcomes using intraaortic balloon pump in. Augmentation of diastolic pressure during balloon inflation contributes to the coronary circulation and the presystolic deflation of the balloon reduces the resistance to systolic output. Using iabpshock ii intraaortic balloon pump in cardiogenic shock ii trial.
Pdf impella support for acute myocardial infarction complicated. Intraaortic balloon pump in myocardial infarction jama. No other percutaneous support device has proven superiority over iabps for treating patients with acute coronary syndrome and other complications of heart failure. Background the leading cause of death in patients hospitalized for acute myocardial infarction is cardiogenic shock. Although the shock ii trial was a well designed one some questions still coming up. Other outcomes were adverse cardiac events during hospitalisation, such as myocardial infarction mi, target vessel revascularisation tvr, stroke, and changes in.
Randomisation performed centrally via internet based program. Treatment with the intraaortic balloon pump iabp is the most common form of mechanical support for the failing heart. Intraaortic balloon pump iabp has been widely used ever since it was first developed in 1962 and became part of clinical practice in 1968. Fibroblast growth factor 23 in acute myocardial infarction complicated by cardiogenic shock. Early revascularization in acute myocardial infarction.
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