Mechanical circulatory support with Impella versus intra-aortic balloon pump or medical treatment in cardiogenic shock—a critical appraisal of current data

Wernly, Bernhard; Seelmaier, Clemens; Leistner, David M.; Stähli, Barbara E.; Pretsch, Ingrid; Lichtenauer, Michael; Jung, Christian; Hoppe, Uta C.; Landmesser, Ulf; Thiele, Holger; Lauten, Alexander

doi:10.1007/s00392-019-01458-2

Cited by 61 publications

(45 citation statements)

References 47 publications

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“…However it is important to note that patients who died during support were excluded from the outcomes analysis [ 22 ]. Finally, a recent meta-analysis of studies comparing Impella to IABP also found higher rates of complications, specifically sepsis and peripheral ischemia, in the Impella group [ 3 ]. In a recent study using the Premier Medical Database, Amin et al noted the Impella to be associated with higher rates of adverse events and in-hospital mortality [ 6 ].…”

Section: Discussionmentioning

confidence: 99%

“…In our study, the pLVAD cohort with complications had higher in-hospital mortality compared to the IABP cohort with complications. Prior studies comparing pLVAD to IABP have either been underpowered to assess mortality [ 22 , 23 , 42 ], or have demonstrated no differences in in-hospital or 30-day mortality [ 3 , 20 ]. This signal was consistent across the various pre-specified sub-groups when stratified by type of AMI-CS, presence of cardiac arrest, early vs. delayed MCS, and receipt of concomitant cardiac surgery.…”

Section: Discussionmentioning

confidence: 99%

“…Cardiogenic shock (CS) is a critical state of end-organ hypoperfusion caused by primary cardiac disease, with up to 80% caused by acute myocardial infarction (AMI) [ 1 ]. In addition to standard therapies for AMI-CS including reperfusion and vasoactive medications, mechanical circulatory support (MCS) devices are often employed to decrease myocardial oxygen demand, reduce left ventricular wall stress, and thus aid in myocardial recovery [ 1 – 3 ]. The intra-aortic balloon pump (IABP) was the first MCS device introduced in the 1960s, and has remained the device of choice in AMI-CS until recently [ 4 ].…”

Section: Introductionmentioning

confidence: 99%

“…The Impella device provides significantly more hemodynamic support than IABP, with increases of 2.5 to 5 L/minute in cardiac output, however has yielded similar clinical outcomes in AMI-CS when compared with the IABP [ 1 , 3 , 18 ]. The PROTECT II study (Prospective, Randomized Clinical Trial of Hemodynamic Support with Impella 2.5 Versus Intra-Aortic Balloon Pump) showed similar outcomes between the Impella 2.5 and IABP in patients high-risk percutaneous coronary intervention (PCI), however it was underpowered to detect differences in complications [ 18 ].…”

Section: Introductionmentioning

confidence: 99%

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Complications from percutaneous-left ventricular assist devices versus intra-aortic balloon pump in acute myocardial infarction-cardiogenic shock

et al. 2020

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Background There are limited data on the complications with a percutaneous left ventricular assist device (pLVAD) vs. intra-aortic balloon pump (IABP) in acute myocardial infarction-cardiogenic shock (AMI-CS). Objective To assess the trends, rates and predictors of complications. Methods Using a 17-year AMI-CS population from the National Inpatient Sample, AMI-CS admissions receiving pLVAD and IABP support were evaluated for vascular, lower limb amputation, hematologic, neurologic and acute kidney injury (AKI) complications. In-hospital mortality, hospitalization costs and length of stay in pLVAD and IABP cohorts with complications was studied.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Complications from percutaneous-left ventricular assist devices versus intra-aortic balloon pump in acute myocardial infarction-cardiogenic shock

et al. 2020

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“…This value is higher than those reported in the French registry (63%) in 2005 [ 5 ] and similar to those from the Italian study (83%) [ 10 ] in 2014. Both coronary revascularization procedures and the availability of an intensive cardiac care unit have been associated with lower mortality rates [ 8 ], although benefits in survival with the use of hemodynamic support devices (i.e., an intra-aortic balloon pump [ 11 ] or Impella support [ 20 , 21 ]) are as yet inconclusive. Furthermore, despite proper reperfusion, no differences in mechanical complications or ventricular arrhythmias were observed over the last 30 years.…”

Section: Discussionmentioning

confidence: 99%

Short- and Long-Term Mortality Trends in STEMI-Cardiogenic Shock over Three Decades (1989–2018): The Ruti-STEMI-Shock Registry

García-García

Oliveras

Ouaddi

et al. 2020

JCM

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Aims: Cardiogenic shock (CS) is an ominous complication of ST-elevation myocardial infarction (STEMI), despite the recent widespread use of reperfusion and invasive management. The Ruti-STEMI-Shock registry analysed the prevalence of and 30-day and 1-year mortality rates in ST-elevation myocardial infarction (STEMI) complicated by CS (STEMI-CS) over the last three decades. Methods and Results: From February 1989 to December 2018, 493 STEMI-CS patients were consecutively admitted in a well-defined geographical area of ~850,000 inhabitants. Patients were classified into six five-year periods based on their year of admission. STEMI-CS mortality trends were analysed at 30 days and 1 year across the six strata. Cox regression analyses were performed for comparisons. Mean age was 67.5 ± 11.7 years; 69.4% were men. STEMI-CS prevalence did not decline from period 1 to 6 (7.1 vs. 6.2%, p = 0.218). Reperfusion therapy increased from 22.5% in 1989–1993 to 85.4% in 2014–2018. Thirty-day all-cause mortality declined from period 1 to 6 (65% vs. 50.5%, p < 0.001), with a 9% reduction after multivariable adjustment (HR: 0.91; 95% CI: 0.84–0.99; p = 0.024). One-year all-cause mortality declined from period 1 to 6 (67.5% vs. 57.3%, p = 0.001), with an 8% reduction after multivariable adjustment (HR: 0.92; 95% CI: 0.85–0.99; p = 0.030). Short- and long-term mortality trends in patients aged ≥ 75 years remained ~75%. Conclusions: Short- and long-term STEMI-CS-related mortality declined over the last 30 years, to ~50% of all patients. We have failed to achieve any mortality benefit in STEMI-CS patients over 75 years of age.

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Association of Use of an Intravascular Microaxial Left Ventricular Assist Device vs Intra-aortic Balloon Pump With In-Hospital Mortality and Major Bleeding Among Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock

Dhruva

Ross

Mortazavi

et al. 2020

JAMA

293

217

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IMPORTANCE Acute myocardial infarction (AMI) complicated by cardiogenic shock is associated with substantial morbidity and mortality. Although intravascular microaxial left ventricular assist devices (LVADs) provide greater hemodynamic support as compared with intra-aortic balloon pumps (IABPs), little is known about clinical outcomes associated with intravascular microaxial LVAD use in clinical practice. OBJECTIVE To examine outcomes among patients undergoing percutaneous coronary intervention (PCI) for AMI complicated by cardiogenic shock treated with mechanical circulatory support (MCS) devices. DESIGN, SETTING, AND PARTICIPANTS A propensity-matched registry-based retrospective cohort study of patients with AMI complicated by cardiogenic shock undergoing PCI between October 1, 2015, and December 31, 2017, who were included in data from hospitals participating in the CathPCI and the Chest Pain-MI registries, both part of the American College of Cardiology's National Cardiovascular Data Registry. Patients receiving an intravascular microaxial LVAD were matched with those receiving IABP on demographics, clinical history, presentation, infarct location, coronary anatomy, and clinical laboratory data, with final follow-up through December 31, 2017. EXPOSURES Hemodynamic support, categorized as intravascular microaxial LVAD use only, IABP only, other (such as use of a percutaneous extracorporeal ventricular assist system, extracorporeal membrane oxygenation, or a combination of MCS device use), or medical therapy only. MAIN OUTCOMES AND MEASURES The primary outcomes were in-hospital mortality and in-hospital major bleeding. RESULTS Among 28 304 patients undergoing PCI for AMI complicated by cardiogenic shock, the mean (SD) age was 65.0 (12.6) years, 67.0% were men, 81.3% had an ST-elevation myocardial infarction, and 43.3% had cardiac arrest. Over the study period among patients with AMI, an intravascular microaxial LVAD was used in 6.2% of patients, and IABP was used in 29.9%. Among 1680 propensity-matched pairs, there was a significantly higher risk of in-hospital death associated with use of an intravascular microaxial LVAD (45.0%) vs with an IABP (34.1% [absolute risk difference, 10.9 percentage points {95% CI, 7.6-14.2}; P < .001) and also higher risk of in-hospital major bleeding (intravascular microaxial LVAD [31.3%] vs IABP [16.0%]; absolute risk difference, 15.4 percentage points [95% CI, 12.5-18.2]; P < .001). These associations were consistent regardless of whether patients received a device before or after initiation of PCI. CONCLUSIONS AND RELEVANCE Among patients undergoing PCI for AMI complicated by cardiogenic shock from 2015 to 2017, use of an intravascular microaxial LVAD compared with IABP was associated with higher adjusted risk of in-hospital death and major bleeding complications, although study interpretation is limited by the observational design. Further research may be needed to understand optimal device choice for these patients.

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Mechanical circulatory support with Impella versus intra-aortic balloon pump or medical treatment in cardiogenic shock—a critical appraisal of current data

Cited by 61 publications

References 47 publications

Complications from percutaneous-left ventricular assist devices versus intra-aortic balloon pump in acute myocardial infarction-cardiogenic shock

Complications from percutaneous-left ventricular assist devices versus intra-aortic balloon pump in acute myocardial infarction-cardiogenic shock

Short- and Long-Term Mortality Trends in STEMI-Cardiogenic Shock over Three Decades (1989–2018): The Ruti-STEMI-Shock Registry

Association of Use of an Intravascular Microaxial Left Ventricular Assist Device vs Intra-aortic Balloon Pump With In-Hospital Mortality and Major Bleeding Among Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock

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