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Haemodynamic efficacy of microaxial left ventricular assist device in cardiogenic shock: a systematic review and meta-analysis.

ABSTRACT: The Impella percutaneous mechanical circulatory support device is designed to augment cardiac output and reduce left ventricular wall stress and aims to improve survival in cases of cardiogenic shock. In this meta-analysis we investigated the haemodynamic effects of the Impella device in a clinical setting. We systematically searched all articles in PubMed/Medline and Embase up to July 2019. The primary outcomes were cardiac power (CP) and cardiac power index (CPI). Survival rates and other haemodynamic data were included as secondary outcomes. For the critical appraisal, we used a modified version of the U.S. Department of Health and Human Services quality assessment form. The systematic review included 12 studies with a total of 596 patients. In 258 patients the CP and/or CPI could be extracted. Our meta-analysis showed an increase of 0.39 W [95% confidence interval (CI): 0.24, 0.54], (p = 0.01) and 0.22 W/m2 (95% CI: 0.18, 0.26), (p < 0.01) for the CP and CPI, respectively. The overall survival rate was 56% (95% CI: 0.50, 0.62), (p = 0.09). The quality of the studies was moderate, mostly due to the presence of confounders. Our study suggests that in patients with cardiogenic shock, Impella support seems effective in augmenting CP(I). This study merely investigates the haemodynamic effectiveness of the Impella device and does not reflect the complete clinical impact for the patient.

SUBMITTER: van Dort DIM

PROVIDER: S-EPMC7113339 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Haemodynamic efficacy of microaxial left ventricular assist device in cardiogenic shock: a systematic review and meta-analysis.

van Dort D I M DIM Peij K R A H KRAH Manintveld O C OC Hoeks S E SE Morshuis W J WJ van Royen N N Ten Cate T T Geuzebroek G S C GSC

Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation 20200401 4

The Impella percutaneous mechanical circulatory support device is designed to augment cardiac output and reduce left ventricular wall stress and aims to improve survival in cases of cardiogenic shock. In this meta-analysis we investigated the haemodynamic effects of the Impella device in a clinical setting. We systematically searched all articles in PubMed/Medline and Embase up to July 2019. The primary outcomes were cardiac power (CP) and cardiac power index (CPI). Survival rates and other haem ...[more]

PMID: 31811556

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Project description:AimsPercutaneous left ventricular assist devices (pVADs) are used to haemodynamically stabilize patients with cardiogenic shock (CS) caused by acute myocardial infarction (AMI). One out of every two patients has a non-ischaemic cause of CS, and these patients differ profoundly from patients with AMI-related CS. We assessed the usefulness of pVAD support for patients with non-ischaemic CS.Methods and resultsWe analysed 106 patients with CS and Impella® support between 2015 and 2018. CS was non-ischaemic in 36 patients and AMI-related in 70 patients. Compared with the AMI group, those in the non-ischaemic group were significantly younger [median age 62 (50.8, 70.8) years vs. 68 (58.0, 75.5) years, P = 0.007] and had more patients with severely reduced left ventricular function (94% vs. 79%, P = 0.035) and worse glomerular filtration rate [45 (27, 57) mL/min vs. 60 (44, 78) mL/min]. Propensity score matching yielded 31 patients with non-ischaemic CS and 31 patients with AMI-related CS, without a difference in baseline laboratory values or comorbidities. In both groups, pVAD support was performed along with haemodynamic stabilization, reduction of catecholamines and normalization of lactate levels. In 7 days, systolic blood pressure increased from 91 (80, 101) mmHg at baseline to 100 (100, 120) mmHg in the non-ischaemic CS group (P = 0.001) and 89 (80, 100) mmHg at baseline to 112 (100, 128) mmHg in the AMI-related CS group (P = 0.001). Moreover, in 7 days, the need of catecholamines (calculated as vasoactive-inotropic score) decreased from 32.0 (11.1, 47.0) at baseline to 5.3 (0, 16.1) in the non-ischaemic group (P = 0.001) and from 35.2 (18.11, 67.0) to zero (0, 0) in the AMI-related CS group (P = 0.001). Lactate level decreased from 3.8 (2.8, 5.9) mmol/L at baseline to 1.0 (0.8, 2.1) mmol/L (P = 0.001) in the non-ischaemic CS group and from 3.8 (2.6, 6.5) mmol/L to 1.2 (1.0, 2.0) mmol/L in the AMI-related group (P = 0.001). In the non-ischaemic CS group, eight patients (25.8%) were upgraded to veno-arterial extracorporeal membrane oxygenation (VA-ECMO) or long-term mechanical circulatory support. Two of these upgraded patients received heart transplantation. In the AMI group, eight patients (25.8%) were upgraded to VA-ECMO or long-term mechanical circulatory support. Ninety-day survival did not significantly differ between the groups (non-ischaemic CS group 48.4%, AMI-related CS group 45.2%, P = 0.799).ConclusionspVAD support is useful for haemodynamic stabilization of patients with non-ischaemic CS and is valuable as a bridge to patients' recovery or long-term left ventricular support and heart transplantation.

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

Haemodynamic efficacy of microaxial left ventricular assist device in cardiogenic shock: a systematic review and meta-analysis.

Publications

Haemodynamic efficacy of microaxial left ventricular assist device in cardiogenic shock: a systematic review and meta-analysis.

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