Dataset Information

Real-World Data on the Intravascular Microaxial Left Ventricular Flow Pump (Impella) in High-Risk Patients.

ABSTRACT: Mechanical circulatory support (MCS) devices maintain or improve hemodynamic profiles in patients at risk for hemodynamic deterioration during percutaneous coronary intervention (PCI) or those in cardiogenic shock. Clinical trials of MCS have been difficult to complete due to challenges with equipoise; however, there are several "real-world" comparative effectiveness analyses of outcomes of patients undergoing high-risk PCI or cardiogenic shock with different MCS. This review summarizes the real-world data on Impella and intra-aortic balloon pump, 2 of the most commonly used MCS, and provides insight into the limitations of such data and challenges to completing clinical trials.

SUBMITTER: Rao SV

PROVIDER: S-EPMC8176068 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature

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Real-World Data on the Intravascular Microaxial Left Ventricular Flow Pump (Impella) in High-Risk Patients.

Rao Sunil V SV

Korean circulation journal 20210601 6

Mechanical circulatory support (MCS) devices maintain or improve hemodynamic profiles in patients at risk for hemodynamic deterioration during percutaneous coronary intervention (PCI) or those in cardiogenic shock. Clinical trials of MCS have been difficult to complete due to challenges with equipoise; however, there are several "real-world" comparative effectiveness analyses of outcomes of patients undergoing high-risk PCI or cardiogenic shock with different MCS. This review summarizes the real ...[more]

PMID: 34085421

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Project description:ImportanceIntravascular microaxial left ventricular assist device (LVAD) compared with intra-aortic balloon pump (IABP) has been associated with increased risk of mortality and bleeding among patients with acute myocardial infarction (AMI) and cardiogenic shock (CS) undergoing percutaneous coronary intervention (PCI). However, evidence on the association of device therapy with a broader array of clinical outcomes, including data on long-term outcomes and cost, is limited.ObjectiveTo examine the association between intravascular LVAD or IABP use and clinical outcomes and cost in patients with AMI complicated by CS.Design, setting, and participantsThis retrospective propensity-matched cohort study used administrative claims data for commercially insured patients from 14 states across the US. Patients included in the analysis underwent PCI for AMI complicated by CS from January 1, 2015, to April 30, 2020. Data analysis was performed from April to November 2021.ExposuresUse of either an intravascular LVAD or IABP.Main outcomes and measuresThe primary outcomes were mortality, stroke, severe bleeding, repeat revascularization, kidney replacement therapy (KRT), and total health care costs during the index admission. Clinical outcomes and cost were also assessed at 30 days and 1 year.ResultsAmong 3077 patients undergoing PCI for AMI complicated by CS, the mean (SD) age was 65.2 (12.5) years, and 986 (32.0%) had cardiac arrest. Among 817 propensity-matched pairs, intravascular LVAD use was associated with significantly higher in-hospital (36.2% vs 25.8%; odds ratio [OR], 1.63; 95% CI, 1.32-2.02), 30-day (40.1% vs 28.3%; OR, 1.71; 95% CI, 1.37-2.13), and 1-year mortality (58.9% vs 45.0%; hazard ratio [HR], 1.44; 95% CI, 1.21-1.71) compared with IABP. At 30 days, intravascular LVAD use was associated with significantly higher bleeding (19.1% vs 14.5%; OR, 1.35; 95% CI, 1.04-1.76), KRT (12.2% vs 7.0%; OR, 1.88; 95% CI, 1.30-2.73), and mean cost (+$51 680; 95% CI, $31 488-$75 178). At 1 year, the association of intravascular LVAD use with bleeding (29.7% vs 24.3%; HR, 1.36; 95% CI, 1.05-1.75), KRT (18.1% vs 10.9%; HR, 1.95; 95% CI, 1.35-2.83), and mean cost (+$46 609; 95% CI, $22 126-$75 461) persisted.Conclusions and relevanceIn this propensity-matched analysis of patients undergoing PCI for AMI complicated by CS, intravascular LVAD use was associated with increased short-term and 1-year risk of mortality, bleeding, KRT, and cost compared with IABP. There is an urgent need for additional evidence surrounding the optimal management of patients with AMI complicated by CS.

Project description:ImportanceAcute 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.ObjectiveTo 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 participantsA 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.ExposuresHemodynamic 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 measuresThe primary outcomes were in-hospital mortality and in-hospital major bleeding.ResultsAmong 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 relevanceAmong 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.

Dataset Information

Real-World Data on the Intravascular Microaxial Left Ventricular Flow Pump (Impella) in High-Risk Patients.

Publications

Real-World Data on the Intravascular Microaxial Left Ventricular Flow Pump (Impella) in High-Risk Patients.

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