The Impella Device: Historical Background, Clinical Applications and Future Directions

Glazier, James J.; Kaki, Amir

doi:10.1055/s-0038-1676369

Cited by 86 publications

(75 citation statements)

References 46 publications

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“…This relationship may become important for the management of transvascular LVAD. Impella 2.5 or sometimes CP cannot necessarily generate sufficient flow to establish total support where LV is no longer ejecting ( 22 ). These transvascular LVADs have often been used for cardiogenic shock ( 23 ).…”

Section: Discussionmentioning

confidence: 99%

The Partial Support of the Left Ventricular Assist Device Shifts the Systemic Cardiac Output Curve Upward in Proportion to the Effective Left Ventricular Ejection Fraction in Pressure-Volume Loop

Kakino

Saku

Nishikawa

et al. 2020

Front. Cardiovasc. Med.

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Left ventricular assist device (LVAD) has been saving many lives in patients with severe left ventricular (LV) failure. Recently, a minimally invasive transvascular LVAD such as Impella enables us to support unstable hemodynamics in severely ill patients. Although LVAD support increases total LV cardiac output (CO TLV ) at the expense of decreases in the native LV cardiac output (CO NLV ), the underlying mechanism determining CO TLV remains unestablished. This study aims to clarify the mechanism and develop a framework to predict CO TLV under known LVAD flow (CO LVAD ). We previously developed a generalized framework of circulatory equilibrium that consists of the integrated CO curve and the VR surface as common functions of right atrial pressure (P RA ) and left atrial pressure (P LA ). The intersection between the integrated CO curve and the VR surface defines circulatory equilibrium. Incorporating LVAD into this framework indicated that LVAD increases afterload, which in turn decreases CO NLV . The total LV cardiac output (CO TLV ) under LVAD support becomes CO TLV = CO NLV +EF e · CO LVAD , where EF e is effective ejection fraction, i.e., E es /(E es +E a ). E es and E a represent LV end-systolic elastance (E es ) and effective arterial elastance (E a ), respectively. In other words, LVAD shifts the total LV cardiac output curve upward by EF e · CO LVAD . In contrast, LVAD does not change the VR surface or the right ventricular CO curve. In six anesthetized dogs, we created LV failure by the coronary ligation of the left anterior descending artery and inserted LVAD by withdrawing blood from LV and pumping out to the femoral artery. We determined the parameters of the CO curve with a volume-change technique. We then changed the CO LVAD stepwise from 0 to 70–100 ml/kg/min and predicted hemodynamics by using the proposed circulatory equilibrium. Predicted CO TLV , P RA , and P LA for each step correlated well with those measured (SEE; 2.8 ml/kg/min 0.17 mmHg, and 0.65 mmHg, respectively, r 2 ; 0.993, 0.993, and 0.965, respectively). The proposed framework quantitatively predicted the upward-shift of the total CO curve resulting from the synergistic effect of LV systolic function and LVAD support. The proposed framework can contribute to the safe management of patients with LVAD.

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Section: Discussionmentioning

confidence: 99%

The Partial Support of the Left Ventricular Assist Device Shifts the Systemic Cardiac Output Curve Upward in Proportion to the Effective Left Ventricular Ejection Fraction in Pressure-Volume Loop

Kakino

Saku

Nishikawa

et al. 2020

Front. Cardiovasc. Med.

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“…47,48 The interventional cardiologist performing left main PCI must possess advanced skill sets, including the ability to treat competently aorto-ostial, heavily calcified and bifurcation lesions, as well as the ability to perform rotational atherectomy (to debulk lesions) and to implant mechanical support devices, such as the Impella device. 49,50…”

Section: Selection Of Mode Of Mechanical Revascularization: Beyond the Syntax Scorementioning

confidence: 99%

Therapeutic Options for Left Main, Left Main Equivalent, and Three-Vessel Disease

2021

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Patients with left main, left main equivalent, and three-vessel coronary artery disease (CAD) represent an overlapping spectrum of patients with advanced CAD that is associated with an adverse prognosis. Guideline-directed medical therapy is a necessary but often insufficient treatment option, as such patients frequently need mechanical revascularization by either coronary artery bypass graft (CABG) surgery or percutaneous coronary intervention (PCI). In patients with advanced CAD presenting with acute myocardial infarction, PCI, of course, is the preferred treatment option. For stable patients with advanced CAD, CABG surgery remains the standard of care. However, observations from the SYNergy between Percutaneous Coronary Intervention with TAXus and Cardiac Surgery (SYNTAX) trial suggest that PCI may be a useful alternative in patients with three-vessel disease with a low SYNTAX score as well as in patients with left main disease and a low or intermediate SYNTAX score. In the subset of patients with diabetes mellitus, the Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease trial unequivocally demonstrated the superiority of CABG surgery in improving outcomes. The findings of the recently published Everolimus-Eluting Stent System versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization and Nordic–Baltic–British Left Main Revascularization study trials point to a favorable role for PCI in certain low-to-moderate risk patients with left main stem disease.

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“…9 The Impella 5.0 device directly unloads the left ventricle, which reduces workload and myocardial oxygen demand, it also increases mean arterial pressure and cardiac output, which in turn increases both coronary and systemic perfusion. [10][11][12] Large-scale, prospective randomized controlled trials (RCTs) of interventions in CS are relatively scarce, in part due to the challenges associated with conducting RCTs in critically ill patients. 13 Available clinical data in CS are therefore largely from retrospective observational analyses.…”

Section: Introductionmentioning

confidence: 99%

Budget Impact Associated with the Introduction of the Impella 5.0® Mechanical Circulatory Support Device for Cardiogenic Shock in France

Guyader¹,

Pernot²,

Delmas³

et al. 2021

CEOR

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Aim: Cardiogenic shock (CS), if not diagnosed and treated rapidly, can lead to irreversible multiorgan damage and death. An economic analysis was conducted to determine the budget impact of the introduction of Impella 5.0 ® , a mechanical circulatory support (MCS) device that directly unloads the left ventricle, into clinical practice in patients with left ventricular CS in France. Methods: A budget impact model was developed to compare the cost of Impella 5.0 with veno-arterial extracorporeal membrane oxygenation (VA-ECMO) from the perspective of the French national healthcare insurer. Costs associated with Impella 5.0, plus complicationrelated costs for VA-ECMO or Impella 5.0 from 2019 were included and clinical input data relating to complication rates and time spent on device were sourced from published literature. Extensive scenario and one-way deterministic sensitivity analyses were performed to explore the influence of uncertainty around key input parameters. Results: Over a time horizon of 5 years, the introduction of Impella 5.0 was associated with cumulative savings of EUR 4.3 million. The results were driven by the lower risk of devicerelated complications associated with Impella 5.0. Savings were apparent from Year 1 onwards, with savings in excess of EUR 375,000 projected in Year 1 alone. On a perpatient level, in Year 1, estimated savings with the introduction of Impella 5.0 totaled EUR 616 per patient. Sensitivity analyses showed that the findings of the analysis were robust. Conclusion:The Impella 5.0 device was associated with cumulative cost savings in excess of EUR 4 million over a 5-year period compared with current practice. Projected savings were driven by a lower rate of device-related complications with Impella 5.0 compared with VA-ECMO.

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The Impella Device: Historical Background, Clinical Applications and Future Directions

Cited by 86 publications

References 46 publications

The Partial Support of the Left Ventricular Assist Device Shifts the Systemic Cardiac Output Curve Upward in Proportion to the Effective Left Ventricular Ejection Fraction in Pressure-Volume Loop

The Partial Support of the Left Ventricular Assist Device Shifts the Systemic Cardiac Output Curve Upward in Proportion to the Effective Left Ventricular Ejection Fraction in Pressure-Volume Loop

Therapeutic Options for Left Main, Left Main Equivalent, and Three-Vessel Disease

Budget Impact Associated with the Introduction of the Impella 5.0® Mechanical Circulatory Support Device for Cardiogenic Shock in France

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