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Utilizing Percutaneous Ventricular Assist Devices in Acute Myocardial Infarction Complicated by Cardiogenic Shock
Published on: June 12, 2021
Intraaortic Balloon Pump in Cardiogenic Shock Complicating Acute Myocardial Infarction: Long-Term 6-Year Outcome of
Holger Thiele1,2, Uwe Zeymer3, Nathalie Thelemann4
1Heart Center Leipzig, University of Leipzig, Germany (H.T., M.A.-W., S.D.).
Insights
Intraaortic balloon counterpulsation (IABP) did not improve long-term survival for patients with cardiogenic shock after heart attack. Mortality remains high despite IABP and revascularization therapy.
Area of Science:
- Cardiology
- Clinical Trials
- Medical Devices
Background:
- The role of intraaortic balloon counterpulsation (IABP) in cardiogenic shock remains debated, with prior trials yielding neutral results.
- Randomized data on the long-term impact of IABP on clinical outcomes in acute myocardial infarction complicated by cardiogenic shock are limited.
- Evidence on general long-term outcomes for cardiogenic shock patients receiving contemporary treatment is scarce.
Purpose of the Study:
- To evaluate the long-term (6-year) effect of IABP on all-cause mortality in patients with cardiogenic shock complicating acute myocardial infarction.
- To assess the impact of IABP on recurrent myocardial infarction, stroke, repeat revascularization, and cardiac rehospitalization.
- To compare the quality of life in survivors treated with IABP versus those in a control group.
Main Methods:
- The study utilized data from the multicenter, randomized, open-label IABP-SHOCK II trial.
- 600 patients with cardiogenic shock complicating acute myocardial infarction undergoing early revascularization were randomized between 2009 and 2012.
- Long-term follow-up was conducted at a median of 6.2 years post-randomization.
Main Results:
- No significant difference in all-cause mortality was observed between the IABP group (66.3%) and the control group (67.0%) at 6-year follow-up (RR 0.99; P=0.98).
- Rates of recurrent myocardial infarction, stroke, repeat revascularization, and cardiac rehospitalization were similar between the groups (all P>0.05).
- Survivor quality of life, assessed by EuroQol 5D and NYHA class, did not differ between the IABP and control groups.
Conclusions:
- Intraaortic balloon counterpulsation (IABP) does not influence all-cause mortality at 6-year long-term follow-up in patients with cardiogenic shock.
- Mortality rates remain high (two-thirds) in patients with cardiogenic shock, even with contemporary revascularization therapy.
- IABP offers no discernible benefit for long-term clinical outcomes in this patient population.
Background:
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. So far, randomized data on the impact of IABP on long-term clinical outcomes in patients with cardiogenic shock complicating acute myocardial infarction are lacking. Furthermore, only limited evidence is available on general long-term outcomes of patients with cardiogenic shock treated by contemporary practice.
Methods:
The IABP-SHOCK II trial is a multicenter, randomized, open-label trial. Between 2009 and 2012, 600 patients with cardiogenic shock complicating acute myocardial infarction undergoing early revascularization were randomized to IABP versus control.
Results:
Long-term follow-up was performed 6.2 years (interquartile range 5.6-6.7) after initial randomization. Follow-up was completed for 591 of 600 patients (98.5%). Mortality was not different between the IABP and the control group (66.3% versus 67.0%; relative risk, 0.99; 95% CI, 0.88-1.11; P=0.98). There were also no differences in recurrent myocardial infarction, stroke, repeat revascularization, or rehospitalization for cardiac reasons (all P>0.05). Survivors' quality of life as assessed by the EuroQol 5D questionnaire and the New York Heart Association class did not differ between groups.
Conclusions:
IABP has no effect on all-cause mortality at 6-year long-term follow-up. Mortality is still very high, with two thirds of patients with cardiogenic shock dying despite contemporary treatment with revascularization therapy.
Clinical Trial Registration:
URL: https://www.
Clinicaltrials:
gov/. Unique identifier: NCT00491036.
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