Randomized Trials of Percutaneous Microaxial Flow Pump Devices

Pahuja, Mohit; Johnson, Adam; Kabir, Ryan; Bhogal, Sukhdeep; Wermers, Jason P.; Bernardo, Nelson L.; Ben‐Dor, Itsik; Satler, Lowell F.; Sheikh, Farooq H.; Waksman, Ron

doi:10.1016/j.jacc.2022.08.807

Cited by 19 publications

(9 citation statements)

References 34 publications

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“…34 The effects of Impella versus no Impella will also be evaluated by the ULYSS trial (NCT05366452) and the RECOVER IV trial (NCT05506449). 35 In this current era, in which evidence of beneficial effects is lacking and the results of the upcoming trials are yet unknown, the results of our study support a careful and individualized assessment of the potential benefits, risks, and resource demands before device initiation.…”

Section: Costssupporting

confidence: 59%

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Impella and venoarterial extracorporeal membrane oxygenation in cardiogenic shock complicating acute myocardial infarction

Bogerd,

ten Berg,

Peters

et al. 2023

European J of Heart Fail

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AimsThis research aimed to give contemporary insight into the use of Impella and venoarterial extracorporeal membrane oxygenation (VA‐ECMO) in myocardial infarction‐related cardiogenic shock (AMICS) and into associated outcomes, adverse events, and resource demands.Methods and ResultsThis nationwide observational cohort study describes all AMICS patients treated with Impella(ABIOMED, Danvers, USA) and/or VA‐ECMO in 2020–2021. Impella and/or VA‐ECMO were used in 20% of all AMICS cases(n = 4088). Impella patients were older (34% vs 13% >75 years, p < 0.001) and less frequently presented after an out‐of‐hospital cardiac arrest (18% vs. 40%, p < 0.001). In‐hospital mortality was lower in the Impella versus VA‐ECMO cohort (61% vs. 67%, p = 0.001). Adverse events occurred less frequently in Impella‐supported patients: Acute haemorrhagic anaemia (36% vs. 68%, p < 0.001), cerebrovascular accidents (4% vs. 11%, p < 0.001), thromboembolisms of the extremities (5% vs. 8%, p < 0.001), systemic inflammatory response syndrome (21% vs. 25%, p = 0.004), acute kidney injury (44% vs. 53%, p < 0.001), and acute liver failure (7% vs. 12%, p < 0.001). Impella patients were discharged home directly more often (20% vs. 11%, p < 0.001) whereas VA‐ECMO patients were more often discharged to another care facility (22% vs. 19%, p = 0.031). Impella patients had shorter hospital stays and lower hospital costs.ConclusionThis is the largest, most recent European cohort study describing outcomes, adverse events, and resource demands based on claims data in patients with Impella and/or VA‐ECMO. Overall, adverse event rates and resource consumption were high. Given the current lack of beneficial evidence, our study reinforces the need for prospectively established, high‐quality evidence to guide clinical decision making.This article is protected by copyright. All rights reserved.

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Section: Costssupporting

confidence: 59%

“…The DanGer Shock trial (NCT01633502) compares Impella versus no Impella in AMICS patients and is well underway 34 . The effects of Impella versus no Impella will also be evaluated by the ULYSS trial (NCT05366452) and the RECOVER IV trial (NCT05506449) 35 …”

Section: Discussionmentioning

confidence: 99%

Impella and venoarterial extracorporeal membrane oxygenation in cardiogenic shock complicating acute myocardial infarction

Bogerd,

ten Berg,

Peters

et al. 2023

European J of Heart Fail

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“…Additionally, as an adjunctive device with ECMO, the Impella rather than IABP was associated with an increased risk of major bleeding and renal injury in an international ECMO registry [ 80 ]. Thus, the results from adequately powered RCTs such as the DanGer Shock ( n = 316) (NCT01633502), RECOVER IV ( n = 560) (NCT05506449), and DTU-STEMI ( n = 668) (NCT03947619) trials are eagerly awaited [ 81 ].…”

Section: Introductionmentioning

confidence: 99%

Complete revascularization in acute myocardial infarction: a clinical review

Saito

Kobayashi

2023

Cardiovasc Interv and Ther

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In patients with ST segment elevation and non-ST elevation myocardial infarction (MI), multivessel (MV) coronary artery disease is found in approximately 50%, leading to worse clinical outcomes. Recent data have suggested that complete revascularization with MV percutaneous coronary intervention is associated with a reduced risk of major adverse cardiovascular events as compared to culprit vessel-only revascularization. However, the optimal timing of MV intervention, appropriate non-culprit lesion assessment, and the best revascularization strategy in specific subsets such as cardiogenic shock remain to be established. This review article summarizes current evidence on revascularization strategies in patients with acute MI and MV disease.

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“…The Impella device (Abiomed, Danvers, MA, USA) can rapidly improve MAP and decrease both LV pressure and volume, resulting in LV unloading and reduced myocardial oxygen consumption. 172 Considering the relevant support provided by this device in terms of CO (peak flows up to 4.3 L/min with Impella CP and up to 6 L/min with Impella 5.5), a trial of de-escalation of pharmacological therapy once haemodynamic stability is achieved with MCS can be feasible. Of note, persistent inotropic support is frequently needed in case of concomitant RV dysfunction, although severe RV failure remains an indication to evaluate mechanical RV support.…”

Section: Concomitant Mechanical Circulatory Support Treatmentmentioning

confidence: 99%

Medical therapy of cardiogenic shock: Contemporary use of inotropes and vasopressors

Riccardi,

Pagnesi,

Chioncel

et al. 2024

European J of Heart Fail

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Cardiogenic shock is a primary cardiac disorder that results in both clinical and biochemical evidence of tissue hypoperfusion and can lead to multi‐organ failure and death depending on its severity. Inadequate cardiac contractility or cardiac power secondary to acute myocardial infarction remains the most frequent cause of cardiogenic shock, although its contribution has declined over the past two decades, compared with other causes. Despite some advances in cardiogenic shock management, this clinical syndrome is still burdened by an extremely high mortality. Its management is based on immediate stabilization of haemodynamic parameters so that further treatment, including mechanical circulatory support and transfer to specialized tertiary care centres, can be accomplished. With these aims, medical therapy, consisting mainly of inotropic drugs and vasopressors, still has a major role. The purpose of this article is to review current evidence on the use of these medications in patients with cardiogenic shock and discuss specific clinical settings with indications to their use.

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Randomized Trials of Percutaneous Microaxial Flow Pump Devices

Cited by 19 publications

References 34 publications

Impella and venoarterial extracorporeal membrane oxygenation in cardiogenic shock complicating acute myocardial infarction

Impella and venoarterial extracorporeal membrane oxygenation in cardiogenic shock complicating acute myocardial infarction

Complete revascularization in acute myocardial infarction: a clinical review

Medical therapy of cardiogenic shock: Contemporary use of inotropes and vasopressors

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