Today we are taping from the european society of cardiology meeting in munich. These findings were further supported by a wellpowered, prospective, randomized clinical trial iabp shock ii trial 12, where they demonstrated that iabp did not reduce 30day mortality or 12 month allcause mortality in patients undergoing early revascularization for myocardial infarction complicated by cardiogenic shock. Intraaortic balloon pump iabp is the most widely used mechanical device for the treatment of ami 3, 4, since its introduction by kantrowitz and. Methods this singlecentre, retrospective study included patients with amics receiving pmcs with either impella or iabp. Guidelines, which previously strongly recommended it, have recently undergone substantial change. Iii progressive increase in use of different, more powerful, mcs devices. The iabp shock ii study recently questioned the clinical utility of intraaortic balloon counterpulsation iabp in patients with acute myocardial infarction and cardiogenic shock. Objective to assess iabp efficacy in acute myocardial infarction data sources human studies found in pubmed, embase, and cochrane libraries through. The hemodynamic effects of the mega intraaortic balloon. The study was approved by national regulatory authorities. There was neither improvement in 30day mortality, nor 1year mortality, nor in any of the secondary outcomes eg.
Decreased urine output after the insertion of iabp can occur because of juxtarenal balloon positioning. However, in this trial the patients represented a rather moderaterisk cohort with a substantially lower shortterm mortality compared to those in other trials 2,9. Intraaortic balloon counterpulsation iabc mechanically augments coronary blood flow, unloads the left ventricle, and reduces myocardial oxygen demand. Cardiovascular outcomes using intraaortic balloon pump in.
Hoppe mentioned wether timing of iabp implantation may have a certain. Jun 25, 2007 intraaortic balloon pump in cardiogenic shock complicating acute myocardial infarction. The iabp shock ii trial is a multicenter, randomized, openlabel trial. Intraaortic balloon counterpulsation in acute myocardial. The last chapter of the iabpshock ii study was the recently published paper reporting the 6year results 7. A metaanalysis that included only cohort studies suggested that the use of an intraaortic balloon pump is associated with a reduction by 11% in the risk of death. Iabpshock ii trial results time to bailout iabp in the. The aim of this study was to compare the hemodynamic effect of the megaseries 50cc and standard 40cc iabps maquet inc. This is an interesting trial because most physicians would assume that a patient with acute mi complicated by cardiogenic shock would be benefited by a balloon pump. The trial randomised postangio patients n 600 to either iabp or no iabp. Final 12 month results of a randomised, openlabel trial. Jul 24, 2012 the trial, known as iabp shock ii, was presented on aug.
Patients with cardiogenic shock complicating acute myocardial infarction who were undergoing early revascularisation and optimum medical therapy were randomly assigned 1. Intraaortic balloon support for myocardial infarction with. Between 2009 and 2012, 600 patients with cardiogenic shock complicating acute myocardial infarction undergoing early revascularization were randomized to iabp versus control. Use of intraaortic balloon pump in cardiogenic shock. Acute myocardial infarction complicated by cardiogenic shock amics remains an important cause of death, despite early percutaneous coronary revascularisation. Pdf impella support for acute myocardial infarction complicated. The trial design of the randomized, openlabel, multicenter iabpshock ii trial and the 30day and 12month results, including the primary end point have been previously published. More than 95% underwent primary pci with stent placement in 90%. The primary end point of the study, 30day allcause mortality, was monitored by the data and safety monitoring board. Iabpshock ii risk score for patients with cardiogenic. One of the new clinical trial updates we will hear about is the 1year data from the intraaortic balloon pump in cardiogenic shock ii iabp shock ii trial, an important, some would say seminal, trial in patients with cardiogenic shock and acute myocardial infarction mi. P shock do not seem to benefit from the use of iabp as measured.
Intraaortic balloon pump therapy for acute myocardial. Intraaortic balloon pump in cardiogenic shock complicating acute. Intraaortic balloon pump in cardiogenic shock complicating acute myocardial infarction. The balloon pump has been the flagship modality for treating cardiogenic shock in spite of scant evidence supporting its use. Iabp shock ii trial and the 30day and 12month results, including the primary end point have been previously published. Patients ineligible for the trial were enrolled in a prospective shock registry. Intraaortic balloon counterpulsation and infarct size in. May 04, 2020 patients ineligible for the trial were enrolled in a prospective shock registry. Intraaortic balloon counterpulsation in acute myocardial infarction complicated by cardiogenic shock iabpshock ii. Overall, 480 patients were included in the final analysis. In a contemporary randomized controlled trial in cs, iabp shock ii, the median dose of adrenaline was 0. Longterm 6year outcome of the randomized iabp shock ii trial. At 30 days, there was no significant difference in the primary outcome of mortality between iabp and controls. I would like to welcome you to this program titled new data and applications of left ventricular assist devices.
The new engl and journal of medicine 1288 n engl j med 367. The direct consequences of the iabp shock ii trial were. Intra aortic balloon counterpulsation learning package. I downgrading of routine use of iabp in amics to a class iii recommendation, level of evidence b, in the european society of cardiology guidelines.
Randomized comparison of optimal medical therapy in. Percutaneous mechanical support in cardiogenic shock. Haemolysis from mechanical damage to red blood cells can reduce the haematocrit by up to 5%. Objectives the iabp shock 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. Slightly less stringent criteria were used in the iabpshock ii trial, but nonetheless this was a trial of cardiogenic shock and you will see mortality rates were high. The first rct to examine whether iabp in addition to pci ameliorates multiorgan dysfunction syndrome in patients with cs postami was the iabp shock trial table 1. 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.
The use of intraaortic balloon pump iabp in stsegment elevation myocardial infarction stemi presenting in cardiogenic shock cs has recently been challenged by the pivotal study iabp shock ii trial thiele h et al. Based upon results from the iabpshock pilot trial, the 2012 esc. August 27, 2012 munich, germany use of an intraaortic balloon pump iabp offered no mortality benefits at 30 days in the 600patient iabp shock ii trial, according to dr holger thiele. While a recent matched pair analysis of 237 patients from the iabp shock ii trial and 237 patients receiving intravascular microaxial lvad in a multinational registry found a point estimate of 2. The iabp, inserted via the femoral artery and positioned in the descending aorta, assists circulation. The effectiveness of intraaortic balloon pump for myocardial. 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. 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. Systolic unloading diastolic augmentation traditionally used in surgical and non surgical patients with cardiogenic shock. Evidence for the use of iabp in mi and cardiogenic shock. Wartono from the division of cardiothoracic surgery, department of surgery. Intraaortic balloon pump in cardiogenic shock ii american college.
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. The iabp shock ii trial failed to show that mechanical support with iabp improved outcomes in ami with cardiogenic shock. Iabp support was strongly advocated in both arms of the shock trial and played an integral role in the medical stabilization arm. Intraaortic balloon pump fails to improve mortality rate in. Renal failure in myocardial infarction with cardiogenic shock. Intraaortic balloon pump in cardiogenic shock complicating. Key takeaways this substudy of the iabp shock ii trial sought to develop an easytouse, readily available risk prediction score for shortterm mortality in patients with amirelated cs undergoing pci. 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. For the 37center iabp shock intraaortic balloon pump in cardiogenic shock ii trial, holger thiele, md, of the university of leipzigheart center leipzig, germany, and colleagues randomized 600 patients with ami and cardiogenic shock who were expected to undergo early revascularization to receive optimal medical therapy with n 301 or. Although there were some limitations to the study, including its relatively. Intraaortic balloon pump in cardiogenic shock ii full text view.
Iabp shock ii trial 2012 the link above points to the evenmoreinteresting 1year followup of the iabp shock ii patients. Most common and widely available methods of mechanical circulatory support temporary support for the left ventricle by mechanically displacing blood within the aorta concepts. Intraaortic balloon pump in cardiogenic shock ii iabpshock ii. No other percutaneous support device has proven superiority over iabps for treating patients with acute coronary. These guidelines have been called into question because of a recently published trial showing that iabp use in patients with cardiogenic shock who were planning to undergo early revascularization did not result in a reduction in 30 day mortality. A new study appears to challenge the traditional assertion that. Randomized comparison of optimal medical therapy in addition. Iabp shock ii trial 600 patients all treated with erv and optimal medical therapy then randomized to iabp 300 or no iabp 298. I am fortunate to have 2 distinguished guests with me today. Ii strong reduction of iabp use in clinical practice 5,6. In the only adequately powered randomized trial of iabp in cs secondary to myocardial infarction iabp shock ii intraaortic balloon pump in cardiogenic shock ii trial short 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.
Reviewing iabp use after recent clinical trials cath lab. The primary goal of intraaortic balloon pump iabp treatment is to increase myocardial oxygen supply and decrease myocardial oxygen demand. The trial, known as iabp shock ii, was presented on aug. This multicenter study downgraded the use of iabp in ami. Pdf impella versus iabp in acute myocardial infarction.
However, the association of adrenaline with mortality was not dependent on the doses of other vasopressors. The iabp shock ii trial was a randomised, openlabel, multicentre trial. Importance intraaortic balloon pump iabp therapy is a widely used intervention for acute myocardial infarction with cardiogenic shock. Intraaortic balloon counterpulsation in acute myocardial infarction complicated by cardiogenic shock iabp shock ii. Iabp for mi with cardiogenic shock linkedin slideshare. The scoring system iabp shock ii score was determined by rounding the respective parameter estimates, attributing either 1 or 2 points to the variables. New data and applications of left ventricular assist. The iabpshock ii trial failed to show that mechanical support with iabp. Intraaortic balloon counterpulsation therapy has been the firstline strategy for patients requiring mechanical circulatory support for more than 40 years. According to the score, the population was classified into three risk categories. No other percutaneous support device has proven superiority over iabps for treating patients with acute coronary syndrome and other complications of heart failure. Intraaortic balloon pump was found to significantly increase the risk of moderate bleeding rr. Impella versus iabp in acute myocardial infarction.
Aug 27, 2012 the iabp shock ii trial the largest trial ever performed in cardiogenic shock randomised 600 patients enrolled in 37 centres in germany to either an iabp or conventional optimal medical. The results of the multicentre, openlabel iabpshock ii trial showed that intraaortic balloon pump iabp counterpulsation. Objective we investigated the benefit of impella, a modern percutaneous mechanical support pmcs device, versus former standard intraaortic balloon pump iabp in acute myocardial infarction complicated by cardiogenic shock amics. 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 primary end point of the study, 30day allcause mortality, was monitored by. Intraaortic balloon pump in cardiogenic shock ii iabp. The trial design of the randomized, openlabel, multicenter iabp shock ii trial and the 30day and 12month results, including. The safety and scientific validity of this study is the responsibility of the study sponsor and. Divaka perera, matthew lumley, and nico pijls, recently wrote an editorial in circulation. The intraaortic balloon pump in cardiogenic shock ii iabpshock ii trial randomized 600 patients with acute mi complicated by cardiogenic shock to either iabp or no iabp. Intraaortic balloon support for myocardial infarction with cardiogenic shock. In the randomized intraaortic balloon pump in cardiogenic shock ii iabp shock ii trial 600 patients with cardiogenic shock cs complicating acute myocardial infarction undergoing early revascularization were assigned to therapy with iabp or no iabp. Acute myocardial infarction complicated by cardiogenic shock has a mortality of more than 50%.
Oct 25, 2012 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. Holger thiele at the european society of cardiology congress, munich, august 27, 2012. 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. Influence of cardiogenic shock with or without the use of. Objective to assess iabp efficacy in acute myocardial infarction data sources human studies found in pubmed, embase, and cochrane libraries through december. Association of use of an intravascular microaxial left.
Cardiovascular interventions1 that discussed the impact of clinical trials iabp shock ii, bcis1, and crispami on intraaortic balloon pump use in the cath lab. The iabp shock ii trial addresses important questions regarding the efficacy and safety of iabp in addition to early revascularization in patients with cardiogenic. Oct 04, 2012 intraaortic balloon support for myocardial infarction with cardiogenic shock. The trial design of the randomized, openlabel, multicenter iabp shock ii trial and the 30day and 12month results, including the primary end point have been previously published. The iabp shock ii trial the largest trial ever performed in cardiogenic shock randomised 600 patients enrolled in 37 centres in germany to either an iabp or conventional optimal medical. The overall utilization of iabp in this group was 86%, 7 considerably higher than the 24% and 25% balloon pump utilization rates seen with shock in. The aim of this study was to evaluate outcomes associated with use of the impella device compared with. There has been an evolution over the last 3 to 4 years in the guidelines for iabp usage in cardiogenic shock. Nov 02, 2012 dr holger thiele university of leipzig, germany gives an overview of the randomized comparison of intraaortic balloon counterpulsation vs optimal medical. Treatment options in cardiogenic shock with intraaortic. Iabpshock ii with dr holger thiele trial and pis youtube. 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. Oct 28, 2012 the balloon pump has been the flagship modality for treating cardiogenic shock in spite of scant evidence supporting its use.
In 190 patients blood samples were collected directly during primary primary. Although the shock ii trial was a well designed one some questions still coming up. Iabp shock ii trial 600 patients all treated with erv and optimal medical therapy then randomized to iabp300 or no iabp298. External validation and comparison of the cardshock and iabp. Percutaneous mechanical circulatory support versus intra. Principles of intraaortic balloon pump counterpulsation. Using iabpshock ii intraaortic balloon pump in cardiogenic shock ii trial inclusion and.