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Archives of cardiovascular diseases
Volume 111, n° 10
pages 601-612 (octobre 2018)
Doi : 10.1016/j.acvd.2018.03.008
Received : 23 January 2018 ;  accepted : 12 Mars 2018
Reviews

Mechanical circulatory support in patients with cardiogenic shock in intensive care units: A position paper of the “Unité de Soins Intensifs de Cardiologie” group of the French Society of Cardiology, endorsed by the “Groupe Athérome et Cardiologie Interventionnelle” of the French Society of Cardiology
Assistance circulatoire mécanique de courte durée dans le choc cardiogénique en unité de soins intensifs de cardiologie : avis et mise au point du groupe USIC de la SFC endossé par le GACI
 

Laurent Bonello a, b, , Clement Delmas c, d, Guillaume Schurtz e, f, Guillaume Leurent g, Eric Bonnefoy h, Nadia Aissaoui i, Patrick Henry j
a Intensive Care Unit, Department of Cardiology, Hôpital Nord, AP–HM, 13015 Marseille, France 
b Inserm UMRS 1076, Aix-Marseille University, Mediterranean Academic Association for Research and Studies in Cardiology (MARS Cardio), 13385 Marseille, France 
c Inserm UMR-1048, Intensive Cardiac Care Unit, Rangueil University Hospital, 31400 Toulouse, France 
d Inserm UMR-1048, Institute of Metabolic and Cardiovascular Diseases (I2MC), 31432 Toulouse, France 
e Cardiac Intensive Care Unit, Institut Coeur Poumon, 59037 Lille, France 
f Inserm U1011, Université de Lille, Institut Pasteur, 59000 Lille, France 
g Inserm 1414, Département de Cardiologie et Maladies Vasculaires, CHU de Rennes, Clinical investigation centre for innovative technology, 35033 Rennes, France 
h UMR 5558, Intensive Cardiac Care Unit, Université Lyon 1, Hospices civils de Lyon, 69622 Bron, France 
i Équipe 4, Inserm U970, Department of Critical Care, Université Paris-Descartes, Hôpital Européen Georges-Pompidou, AP–HP, 75015 Paris, France 
j Department of Cardiology, Paris–Diderot University, Lariboisiere Hospital, AP–HP, 75010 Paris, France 

Corresponding author. Service de cardiologie, hôpital Nord, AP–HM, chemin des Bourrely, 13015 Marseille, France.Service de cardiologie, hôpital Nord, AP–HMchemin des BourrelyMarseille13015France
Summary

Cardiogenic shock (CS) is a major challenge in contemporary cardiology. Despite a better understanding of the pathophysiology of CS, its management has only improved slightly. The prevalence of CS has remained stable over the past decade, but its outcome has seen few improvements, with the 1-month mortality rate still in the range of 40–60%. Inotropes and vasopressors are the first-line therapies for CS, but they are associated with significant hazards, and have well-known deleterious effects. Furthermore, a significant number of patients develop refractory CS with haemodynamic instability, causing critical organ hypoperfusion and/or pulmonary congestion, despite increasing doses of catecholamines. A major change has resulted from the recent advent and availability of potent mechanical circulatory support (MCS) devices. These devices, which ensure sustained blood flow, provide a great and long-awaited opportunity to improve the prognosis of CS. Several efficient MCS devices are now available, including left ventricle-to-aorta circulatory support devices and full pulmonary and circulatory support with venoarterial extracorporeal membrane oxygenation. However, evidence to support their indications, the timing of implantation and the selection of patients and devices is scarce. Because these devices are gaining momentum and are becoming readily available, the “Unité de Soins Intensifs de Cardiologie” group of the French Society of Cardiology aims to propose practical algorithms for the use of these devices, to help intensive care unit and cardiac care unit physicians in this complex area, where evidence is limited.

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Résumé

Le choc cardiogénique (CC) reste un enjeu majeur de la cardiologie contemporaine. Malgré une meilleure compréhension de sa physiopathologie, sa prise en charge n’a que peu évoluée. Au cours de la dernière décennie, sa prévalence est restée stable mais son pronostic ne s’est que peu amélioré avec une mortalité à un mois comprise entre 40 % et 60 %. Les inotropes et les vasopresseurs forment la première ligne de traitement dans le CC mais ils ont une efficacité variable et des effets délétères bien connus. De plus un nombre significatif de patients développent un CC réfractaire avec une hémodynamique instable et une hypoperfusion d’organe et/ou une congestion malgré des doses croissantes de catécholamines. La mise à disposition récente de systèmes efficaces de support hémodynamique mécanique représente un changement majeur. Ces dispositifs, qui assurent un support au flux sanguin, représentent une grande opportunité, attendue depuis longtemps, d’améliorer le pronostic du CC. Il y a aujourd’hui plusieurs systèmes de support hémodynamique mécaniques disponibles allant de dispositifs de support circulatoire du ventricule gauche vers l’aorte à un support cardio-pulmonaire complet avec les systèmes de circulation extracorporelle incluant une membrane d’oxygénation. Cependant les données concernant leurs indications, leur délai d’implantation, la sélection des patients ou du dispositif sont peu nombreuses. Du fait de la grande disponibilité de ces dispositifs et de l’équipement rapide des centres, le groupe « unité de soins intensifs cardiologiques » de la société française de cardiologie a voulu proposer un algorithme pratique d’utilisation pour aider les médecins de soins intensifs dans ce domaine où les données scientifiques sont rares.

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Keywords : Cardiogenic shock, Mechanical circulatory support, Intensive care unit, Acute heart failure, Acute coronary syndrome

Mots clés : Choc cardiogénique, Support hémodynamique mécanique, Unité de soins intensifs, Insuffisance cardiaque aiguë, Syndrome coronaire aigu

Abbreviations : ACS, CS, ECMO, IABP, ICU, INTERMACS, MCS, PCI, TTE


Background

The optimal therapeutic strategy for cardiogenic shock (CS) is a major concern in contemporary practice. The prevalence of CS is stable, but its prognosis has seen little improvement over the last decade, with a 1-month mortality rate of approximately 40–60% [1]. Catecholamines are the first-line therapy, but they have well-known deleterious effects. Moreover, some patients remain in refractory CS, with persistent critical organ hypoperfusion and/or pulmonary congestion, despite increasing doses of catecholamines [2].

A paradigm shift has taken place in the care of patients with CS with the advent of effective and easy-to-use percutaneous devices that provide potent circulatory support. Several studies have shown that mechanical circulatory support (MCS) could be a lifesaving therapy in CS, but conducting randomized trials in this clinical setting is challenging (ClinicalTrials.gov: NCT02301819; NCT02544594). MCS devices provide a great opportunity to enhance patient prognosis; they continue to increase in popularity, and should become available in non-surgical centres with level 2 intensive care units (ICUs), to allow timely support and improved prognosis.

Here, we summarize the available evidence for the use of MCS devices, and provide practical algorithms to help guide physicians when caring for patients with CS.

Definition of CS

CS is defined as a cardiac disorder, with both clinical and biological evidence of tissue hypoperfusion. Although the clinical definition of CS varies, it usually includes hypotension (systolic blood pressure90mmHg) despite adequate filling pressures, and signs of organ hypoperfusion [3].

The pathophysiology of CS is complex, and involves dysfunction of one or two ventricles, leading to a decreased cardiac index (CI) along with vascular dysfunction, resulting in hypoperfusion and malfunction of target organs (mainly the brain, liver and kidneys). A vicious circle results in multiorgan failure and death without intensive and efficient care [4].

Finally, while there is one definition of CS, there are several profiles of severity, from life-threatening refractory hypotension, despite rapidly escalating inotropic or vasopressor support, with critical organ hypoperfusion to inotrope dependence [5].

First steps in CS management

Once the diagnosis is confirmed, early and efficient therapies are emergently required to prevent multiorgan failure and death. Transthoracic echocardiography (TTE) plays a key role, not only in the diagnosis but also in the evaluation and monitoring of the haemodynamic state and filling pressures, which can evolve rapidly over a short period of time. TTE is widely available, and can quickly assess cardiac index, left ventricular pressure, volume status and systemic vascular resistance; it can also detect pericardial effusion or structural defects, such as mechanical complications of myocardial infarction, and help to guide the therapeutic strategy. In some cases – especially in patients who do not respond to initial management – invasive monitoring with PiCCO or a Swan-Ganz catheter may be required.

Early identification of patients with CS should be a therapeutic goal, to reduce time to therapy. From a therapeutic point of view, the current guidelines on acute heart failure support a three-point therapeutic strategy. First, to support the failing heart with an inotrope, dobutamine (class IC) is used to increase the cardiac index and, if required, a vasopressor, such as norepinephrine (class IIbC), is added, to restore a mean arterial pressure of 65mmHg [3, 6, 7]. Second, adequate fluid management is necessary, usually to reduce volume overload with diuretics. At the same time, aetiological management is mandatory, including early revascularization of the culprit lesion with percutaneous coronary intervention (PCI) in the case of acute coronary syndrome (ACS) [8, 9]. In all cases of CS, clinicians must identify the aetiology or precipitating factors to enable specific treatment when possible, including cardioversion in case of life-threatening arrhythmias or cardiac surgery in case of severe valvulopathy or mechanical complications following an ACS. However, despite this therapeutic strategy, a significant number of patients do not improve or experience worsening haemodynamic status. Despite appropriate intensive care, refractory CS occurs in 15–20% of patients. MCS devices are being used increasingly in this clinical setting [10].

Timing of MCS device implantation

Because of the numerous aetiologies of CS, patients’ diverse medical histories, delays in management and tolerance of inotrope therapies, the optimal timing of MCS device implantation is not standardized. To optimize the management of patients with CS, a multidisciplinary discussion before implantation is required in most cases.

Some MCS devices can be proposed very early in the management of CS, to replace inotrope therapy. Indeed, there is evidence supporting early implantation of MCS devices in CS after an ACS [11, 12].

Most MCS devices are used to complement the usefulness or insufficiency of inotrope therapy in patients with CS. In these clinical settings, associated with a rapidly deteriorating haemodynamic state – the so-called “crash and burn” presentation, despite adequate medical therapy – early implantation of an MCS device should be proposed.

In contrast, in patients presenting with CS resulting from acutely decompensated heart failure, the time to make a decision about implantation may be extended, because the clinical presentation is progressive in most cases, and the likelihood of myocardial recovery is reduced, preventing secondary weaning from MCS.

The potential detrimental effects of the escalation of vasoactive agents could be reduced with a shorter “time to support” although this has not been demonstrated to date. The ultimate goal of the optimal timing of MCS is to prevent irreversible multiorgan failure, a situation in which any device may not reverse the situation, as observed in the IMPRESS trial [13]. Thus, networks and protocols should aim to reduce the “time to support”.

Short-term MCS devices available in France

MCS devices available in France are detailed in Table 1. These devices differ in several ways, including ease of insertion, properties and degree of support. In contrast to the other devices, extracorporeal membrane oxygenation (ECMO) provides complete cardiopulmonary support.

Intra-aortic balloon pump

Quickly inserted through the femoral artery, the intra-aortic balloon pump (IABP) is positioned in the descending aorta. Because of the diastolic inflation of the balloon coupled with prompt systolic deflation, its benefits include increased coronary perfusion, decreased left ventricular afterload, which reduces myocardial oxygen consumption, and a mild increase in cardiac output [14]. However, its haemodynamic properties are modest in clinical settings.

An IABP is inexpensive, quick and easy to use, and has relatively low complication rates. However, in the area of PCI, the IABP failed to show a clinical benefit in CS or to reduce infarct size [15, 16]. Thus, the routine use of an IABP as part of CS care is no longer recommended (class III), but it may be used for the mechanical complications of ACS [8].

Impella® devices

Impella® devices (Abiomed, Danvers, MA, USA) are continuous flow pumps inserted percutaneously into the left ventricle (Impella 2.5® and Impella CP® devices) or via a surgical approach (Impella 5.0® device). This catheter pumps blood from the left ventricle, which is ejected in the ascending aorta, providing a sustained and reliable continuous high-volume output, and simultaneously unloading the left ventricle, thus reducing energy demand and myocardial injury. Depending on the catheter inserted, flow varies between 2.5 and 5L/min. The Impella 2.5® and Impella CP® catheters can be inserted quickly in the catheterization laboratory.

In a pilot study, the Impella 2.5® device was compared with the IABP in acute myocardial infarction complicated by CS in patients undergoing PCI. The Impella 2.5® device provided a 0.53L/min increase in cardiac index compared with 0.11L/min for the IABP, confirming its superior haemodynamic properties (P =0.02) [17] The prospective randomized IMPRESS trial observed no mortality benefit for the Impella CP® device compared with the IABP in 48 patients with severe CS complicating ACS who were undergoing PCI (50% vs. 46%; P =0.9) [13] However, this study was underpowered, and mainly included patients who had had a cardiac arrest.

The USpella registry provided real-world data on the Impella 2.5® device in patients presenting with ACS complicated by refractory CS, and reported improved a 65.1% survival rate at 30 days [18]. This result is consistent with another registry supporting early implantation in CS complicating ACS to reduce adverse events [19].

Regarding safety, it should be emphasized that the rate of vascular complications is high (vascular repairs in 9.7% of patients, blood transfusions in 17.5%, limb ischaemia in 3.9% and haemolysis in 10.3%). Recent large registries in Europe and the USA have confirmed the haemodynamic benefits, but also the high rate of complications associated with the Impella® device [18, 19, 20].

ECMO

The ECMO machine is implanted using a percutaneous or surgical approach, using a modified Seldinger technique. Blood is aspirated by a venous cannula (23–29 Fr) from the right atrium and inferior vena cava, and is reinjected through an arterial cannula into the femoral (or sometimes the axillary) artery (15–19 Fr), after oxygenation and decarboxylation by the combination of a centrifugal pump and an oxygenator [21].

With a flow of 5L/min, ECMO provides a full substitute to the failing heart; it allows a decrease in left ventricular preload, but also increases left ventricular afterload, with a subsequent increase in cardiac work and myocardial oxygen consumption, which may cause pulmonary oedema.

ECMO is also associated with vascular and cutaneous complications (particularly ipsilateral limb ischaemia), justifying systematic reperfusion of the limb. In addition to these local complications, systemic complications may include haematological issues (haemolysis, thrombocytopoenia, bleeding and transfusion) or emboli [22, 23].

ECMO use has been reported in several CS settings, including ACS, myocarditis post-cardiotomy and intoxication, with encouraging results. Indeed, studies have reported 1-month and in-hospital survival rates reaching 60% in refractory patients with CS [22, 23, 24, 25, 26, 27, 28]. A recent meta-analysis showed a survival benefit of ECMO compared with the IABP in refractory cardiac arrest and ischaemic CS [29]. To date, no randomized study has evaluated ECMO efficacy in CS management, but studies are ongoing (ClinicalTrials.gov: NCT02870946; NCT02301819).

Specific case of isolated right ventricular dysfunction

In some cases of isolated right ventricular dysfunction, MCS may be required. In addition to the total heart-lung bypass provided by ECMO, the Impella RP® catheter allows direct support of the right ventricle by improving flow from the right atrium to the pulmonary arteries. Two recent studies reported a 30-day survival rate of 70% in patients with CS presenting with right ventricular dysfunction [30, 31]. In cases of biventricular failure, the use of a combination of devices seems feasible, as demonstrated by the recent Bi-Pella case series [32].

Potential indications

It is of utmost importance that MCS programmes are developed using a multidisciplinary approach. Furthermore, protocols must be developed with close collaboration between the implanting centres and tertiary centres with surgical back-up, to optimize and secure patient care and projects.

Short-term MCS is potentially useful in ventricular systolic dysfunction responsible for low cardiac output. Numerous cases and series have been published, showing that MCS devices may contribute to improved outcomes in various clinical settings responsible for inadequate cardiac output [20]. However, it must be emphasized that most of the studies suffered from major methodological limitations, including non-randomization, selective selection and small sample size. Therefore, the actual benefit of short-term cardiac assist devices should be balanced with the risk of complications and associated costs.

Aetiology is an important factor in the usefulness of MCS device implantation. Situations suggesting recovery of ventricular function, including ACS with early appropriate revascularization, fulminant myocarditis, stress cardiomyopathy or drug intoxication, are optimal indications for MCS, with a positive risk/benefit balance. On the other hand, dramatic clinical settings, such as refractory cardiac arrest, are not appropriate for MCS, because no circulatory device can reverse anoxic encephalopathy [13].

In Table 2 we provide a tentative list of potential indications in which cardiac recovery or patient project may trigger the use of MCS.

Patient selection for MCS

Patient selection for MCS is critical. It is difficult in the acute setting to accurately assess patient prognosis and/or response to medical treatment on admission, and consequently to define the best approach to each individual case. In some cases, the initial prognosis is unknown, but the exceptional context of the situation may lead the medical team to consider MCS to allow time to decide (bridge to decision) or to stabilize the patient's condition (bridge to candidacy).

Some patients should not be considered for MCS, including the elderly, those with profound refractory CS and multiorgan failure, those with major co-morbidities or neurological injury and patients for whom recovery potential or long-term prognosis are lacking (Table 3). However, it should be emphasized that these relative contraindications do not replace the clinical judgment of the multidisciplinary team, and the fact that some contraindications may be overcome by MCS; severe organ failure is one such example. Of note, as reported in a recent meta-analysis, MCS in an unselected population with acute myocardial infarction complicated by CS does not result in a mortality benefit; in reality, it leads to an increased risk of bleeding related to MCS [33] (Table 3).

With the available evidence to date, we consider that eligible patients should be: those with a significantly high likelihood of (at least) partial recovery of heart function (Table 2), in whom vasoactive drugs fail to restore organ perfusion or are responsible for adverse effects; and those with long-term project with access to long-term MCS and/or heart transplantation.

Potential indications must be validated before and during evaluations by the shock teams and regional networks, including tertiary centres.

CS management algorithms

To limit therapeutic impasses, while maximizing the chances of success, it is essential that a dedicated CS team is available 24/7 in centres with an MCS capability and a level 2–3 ICU, as defined by the Acute Cardiovascular Care Association [7, 33] (Appendix A). Clinicians must discuss possibilities and therapeutic limitations with patients, family and care teams, to decide on the appropriate therapeutic strategy.

Patients presenting with CS should be transferred to a level 2–3 ICU for evaluation by a shock team, with advanced MCS possibilities (Figure 1). When CS is recognized in centres without an MCS capability, patients should be transferred after medical stabilization when possible; alternatively, a mobile unit of cardiac assistance (MUCA) should be activated for MCS implantation before transport.



Figure 1


Figure 1. 

Regional network and care protocols for patients with cardiogenic shock (CS). IABP: intra-aortic balloon pump; ICU: intensive care unit; MUCA: mobile unit of cardiac assistance; PCI: percutaneous coronary intervention.

Zoom

The choice of MCS must be based on the aetiology of CS, the patient's haemodynamic and respiratory status and an estimate of the “time to support”. Thus, in the event of exclusive or predominant left ventricular failure, percutaneous Impella CP® (or surgical Impella 5.0®) should be considered. In contrast, in cases of right ventricular or biventricular failure, multiorgan failure or associated respiratory failure, ECMO is preferred.

The timing of the MCS is dependent on CS aetiology, severity and speed of onset. We thus provide two algorithms to encompass the various presentations.

CS in the context of ACS

In this situation, MCS should be considered early before PCI in the catheterization laboratory, to provide support and enable a safe revascularization procedure (Figure 2). Early implantation will also limit the use of medication and improve myocardial perfusion, thus promoting myocardial recovery by limiting myocardial necrosis. In this indication, the Impella CP® device appears to be the most suitable, because of its rapid insertion and ease of use. Close monitoring is essential for tailored support; it also provides relevant indicators of cardiac recovery or the need for escalation of support (Table 4).



Figure 2


Figure 2. 

Algorithm for cardiogenic shock related to acute coronary syndrome (ACS). ECMO: extracorporeal membrane oxygenation; IABP: intra-aortic balloon pump; LV: left ventricular; LVAD: left ventricular assist device; MCS: mechanical circulatory support; PCI: percutaneous coronary intervention; RV: right ventricular; TTE: transthoracic echocardiography; V-A: venoarterial.

Zoom

Of note, during the last decade, prophylactic MCS use in high-risk PCI has emerged as a potential indication. This is generally restricted to situations involving planned or emergent PCI in patients with complex lesion subsets (left main trunk, last remaining artery) and severe left ventricular impairment [34]. While the potential utility of ECMO in these situations has been reported [35], the IABP and Impella® are the devices used most frequently [36]. The additional value of planned utilization of IABP was demonstrated in a meta-analysis of randomized trials [37]. The clinical evidence suggests that in selected cases of high-risk PCI, when haemodynamic instability may occur, use of MCS before PCI reduces the event rate. In these cases, the Impella® device, with its superior haemodynamic capacities, may be chosen as the first-line treatment.

CS with other aetiologies

There are typically two clinical settings (Figure 3). The first is a crash and burn situation when, despite the use of inotropes and vasopressors, the patient cannot be stabilized within a few minutes or few hours (Interagency Registry for Mechanically Assisted Circulatory Support [INTERMACS] 1) [5]. In these cases, quick implementation of MCS is required, based on the time to therapy for each device. The second situation is when inotropes and vasopressors initially stabilize a patient, but they subsequently decline or cannot be weaned (INTERMACS 2 and 3). These patients are mainly those with chronic heart failure who, in most cases, would benefit from ECMO or the Impella 5.0® device before or after transfer to a dedicated tertiary centre, if a long-term project is possible.



Figure 3


Figure 3. 

Algorithm for cardiogenic shock not related to acute coronary syndrome (ACS). ECMO: extracorporeal membrane oxygenation; LV: left ventricular; LVAD: left ventricular assist device; MCS: mechanical circulatory support; TTE: transthoracic echocardiography; V-A: venoarterial.

Zoom

Management of patients under MCS in the ICU

A successful outcome is highly dependent on repetitive safe practices by a multidisciplinary team, including physicians, nurses and ECMO and Impella® specialists [38].

Patient-related management

Patients must be closely monitored to quickly assess if they may be weaned or upgraded. For this purpose, patients with CS require continuous telemetry, pulse oximetry, invasive arterial blood pressure and urine output monitoring. Furthermore, frequent clinical examination (cold sweaty extremities, mental status) and laboratory measurements, such as those of lactate, mixed venous oxygen saturation (SvO2 ), serum electrolytes (initially every few hours), coagulation, blood counts and renal and liver function (at least twice daily), are necessary to ensure effective care. Moreover, clinicians must be able to assess cardiac output frequently through the use of TTE, PiCCO or a Swan-Ganz catheter. Bedside echocardiography should be readily available 24/7 for patients with MCS, and must be performed at least every day, and more frequently if the patient becomes unstable.

The goal of management is to first stabilize the patient's haemodynamic status, to enable reversal of organ failure. Because of the lack of CS-specific studies, the current goals that should be considered are a mean arterial pressure of 65mmHg and/or a cardiac index>2.2L/min/m2, with an emphasis on restoring tissue perfusion (lactate, urine output or consciousness) (Table 4).

Patients requiring short-term assist devices are often on high doses of vasopressors and/or inotropes when MCS is started. After implantation, physicians should aim to reduce and/or withdraw inotropes and vasopressors to decrease myocardial work and enhance microcirculation, both of which favour myocardial recovery.

If the patient is not haemodynamically stable and/or has evidence of tissue hypoperfusion, clinicians must reassess ventricular function, respiratory and neurological status, exclude MCS malfunction and then discuss upgrading support (Impella 5.0®, ECMO).

At each stage of care, a multidisciplinary evaluation is recommended to determine the most appropriate care, between upgrading support (i.e. long-term assist device, heart transplantation) or palliative care if the patient's haemodynamic condition is unfavourable despite current therapies. Transfer to a tertiary centre then becomes mandatory [3, 6].

Device-related management

For both devices, anticoagulant therapy is required, targeting an anti-Xa concentration of 0.3–0.6 IU/mL with unfractionated heparin.

ECMO

Nurses and physicians should continuously monitor the ECMO circuit. Careful examination of the circuit and cannula may detect potential complications, such as clotting, infections at the cannula sites, bleeding and haemolysis. ECMO results in an increased left ventricular afterload that can cause cardiogenic pulmonary oedema and may require left ventricular venting with IABP, Impella®, atrioseptostomy, hybrid cannulation (triple cannulation) or surgical ECMO centralization [39, 40, 41, 42].

Impella®

Ensuring proper positioning of the device in the left ventricle is key, and should be checked after transition to the ICU and daily thereafter. It is recommended that a checklist is completed upon arrival in the ICU (Appendix B). Similar to ECMO, systemic anticoagulation is required with unfractionated heparin to prevent device thrombosis. Haemolysis is a frequent and predictable complication that must be monitored with prolonged use of the device. Correct positioning of the device is easily confirmed with a chest X-ray and/or TTE; this is necessary for optimal system efficiency. The Impella® device is strongly dependent on volume status, which must be carefully monitored.

Weaning from MCS, or bridge or destination therapy

After a neurological evaluation confirming the lack of disability, the first consideration is potential myocardial recovery. In this case, weaning may be considered, based on clinical status and cardiac function monitoring. Because recovery is most likely to occur within the 48hours following revascularization in the case of ACS, this duration of support is likely to be necessary. In contrast, some patients, such as those with terminal dilated cardiomyopathy or other aetiologies without recovery probability, should be bridged to cardiac transplantation or to a long-term ventricular assist device, unless a very specific decompensation factor (such as rapid supraventricular arrhythmia or severe septic shock) is identified.

With ECMO, reduction of blood flow should be performed as soon as the patient is haemodynamically stable with no or low-dose vasoactive drugs and recovered pulsatile flow. Doppler echocardiography variables (aortic velocity time integral>12cm/s and lateral S wave>5.8cm/s) are the most robust predictors of successful weaning in this setting [43, 44].

No study has assessed a weaning strategy for an Impella® device. Experienced teams recommend decreasing the level of assistance at 1–1.5L/min over 4–6hours, and assessing routine clinical, biological and echocardiographic variables of haemodynamic stability and tissue perfusion before withdrawal.

Perspectives

The availability of new user-friendly easy-to-insert and efficient MCS devices is a major step towards improved outcomes in patients with CS. These devices allow restoration of blood flow for organ perfusion, thus preventing or reversing multiorgan failure and death; they may also limit myocardial injury and foster recovery, while allowing safe and complete PCI in case of ACS-related CS. Widespread availability of these devices is required to optimize CS care and reduce the “door-to-support time” in a similar manner for ACS or acute heart failure management.

Level 2 and 3 ICUs, according to the Acute Cardiovascular Care Association definition, should have efficient MCS to provide timely and accurate support in patients with CS within regional networks [33]. Networks of care coordinating emergency rooms and pre-hospital care along with level 2 ICUs and tertiary centre availability are warranted. These networks should define a protocol for the selection criteria for patients, timing of implantation and devices.

While the selection of patients remains challenging, it is critical that the patient's prognosis is considered initially in order to proceed adequately at all the required steps. The optimal timing of implantation and the optimal device have not been evaluated prospectively, although early implantation in rigorously selected patients with CS may be the only strategy capable of improving the prognosis of patients with CS [11, 12].

Conclusions

To improve the clinical outcomes of patients with CS, regional networks should be implemented, and level 2 ICUs should be equipped with effective MCS. MCS devices represent a promising strategy to improve patient outcomes. The proposed algorithms should be adapted by each network and used in selected patients.

Funding

None.

Disclosure of interest

The authors declare that they have no competing interest.


Appendix A. Appendix A

app1



Level 1 ICU : Basic CV intensive care Level 2 ICU: Advanced CV intensive care Level 3 ICU: Cardiovascular critical care 
Emergency department in hospital Level 1 ICU + Level 2 ICU + 
All non invasive parameter monitoring 24/7 PCI Extracorporaela life support 
24/7 echographic and thoracic US Pulmonary artery catheter Renal replacement therapy 
Non invasive ventilation Pacing, resynchronisation therapy, ICD Mechanical ventilation 
 Ablation therapy  
 Temporary pacing  
 Percutaneous circulatory support  

ICU: intensive care unit; PCI: percutaneous coronary intervention; Cv: cardiovascular; US: ultrasound


Appendix B. Appendix A

Impella checklist (procedures are similar with Impella 2.5, CP or 5.0)

Avoiding contra-indications: LV thrombus, severe aortic valvulopathy or mechanic aortic valve, tamponnade, right heart failure, severe arterial peripheral disease and/or tortuosity.

Checklist in the Cathlab

arterial puncture under ultrasound guidance is recommended
once Impella is advanced through the aortic valve, correct positionning must be confirmed with fluoroscopy (inlet area of the catheter must be 3.5cm below the aortic valve annulus and in the mid-LV chamber) and Impella Controller (placement signal screen showing an aortic waveform, motor signal showing a pulsatile one)
start the device. Flow will reach its maximum value in few seconds and then confirm stable position. Select the lowest P-level that will enable optimal patient's support. P8 is the recommended level for continuous use.
Careful attention when patient is transferred within the hospital (battery capacity, catheter position…)

Checklist in the ICU

1)
Device related
check optimal positionning with the Impella Controller, transversal marks on the catheter shaft, chest x-ray, TTE or TEE, fluoroscopy if needed
switch P-level if necessary to enable sufficient support (avoiding P1and P9 for a long time)
transfer purge system to « standard configuration » and verify pressure bag
secure Impella catheter on patient's leg
2)
Patient's related
close monitoring of hemodynamic and respiratory status (see chapter 6), volemia and right ventricular function
Signs of sepsis
vascular access must be verified daily (hemorrhage, limb ischemia…)
detect signs of hemolysis (dark or blood-colored urine, renal failure…)
3)
Biological parameters
hemodynamic parameters/tissular hypoperfusion : lactate, SvO2, renal-liver function, blood gases
hemolysis parameters : LDH, haptoglobin, plasma-free hemoglobin +++
regular coagulation test to prevent thrombus formation (TCA between 2 and3)

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