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Archives of cardiovascular diseases
Volume 110, n° 8-9
pages 433-438 (août 2017)
Doi : 10.1016/j.acvd.2017.03.002
Received : 23 February 2017 ;  accepted : 21 Mars 2017
Cardiogenic shock management: Still a challenge and a need for large-registry data
Prise en charge du choc cardiogénique : encore un défi nécessitant la réalisation de larges registres
 

Clement Delmas a, b, , Guillaume Leurent c, Nicolas Lamblin d, Eric Bonnefoy e, François Roubille f, g
a Intensive Cardiac Care Unit, Cardiology Department, University Hospital of Rangueil, Toulouse, France 
b Intensive Care Unit Rangueil, Anaesthesia and Critical Care Department, University Hospital of Rangueil, Toulouse, France 
c Service de Cardiologie et Maladies Vasculaires, CHU de Rennes, Université de Rennes 1, LTSI, INSERM, U1099, Rennes, France 
d Université de Lille, INSERM, CHU de Lille, Institut Pasteur, U1167, Lille, France 
e Hospices Civils de Lyon, Université Claude-Bernard Lyon 1, Lyon, France 
f Cardiology Department, University Hospital of Montpellier, Montpellier, France 
g PhyMedExp, University of Montpellier, INSERM U1046, CNRS UMR 9214, Montpellier, France 

Corresponding author. Intensive Care Unit, University Hospital of Toulouse Rangueil, 1, avenue Jean-Poulhes, 31059 Toulouse cedex, France.

Keywords : Cardiogenic shock, Clinical trial, Registry

Mots clés : Choc cardiogénique, Études cliniques, Registre

Abbreviations : ACS, CS, IABP


Cardiogenic shock (CS) is defined as organ hypoperfusion secondary to impaired cardiac output. CS criteria have been well codified since the SHOCK study [1], combining systolic blood pressure<90mmHg for>30minutes or the need for vasopressors to maintain systolic blood pressure>90mmHg; pulmonary congestion or increased left ventricular pressures; and organ malperfusion signs (impaired consciousness or confusion, cold extremities or marbling, oliguria and increased serum lactate). Beyond the clinical signs, assessment of cardiac output and left ventricular filling pressures with transthoracic echocardiography or right catheterization is needed [2, 3].

Lack of clinical applicability of the CS definition

In clinical practice, CS presentations include a large span of different clinical conditions, from the state of “pre-shock” to severe shock refractory to treatment. Even if used widely in clinical practice, defining these different shock states is difficult. In clinical practice “pre-shock” is a term often used to define patients who do not fulfil shock criteria at admission, but who are at high-risk of developing shock or present with clinical signs of haemodynamic instability, such as tachycardia with normal blood pressure. Yet, this definition is subjective, and is difficult to apply on a daily basis. Similarly, the definition of refractory CS is unclear: it is classically defined as the absence of response to conventional medical treatment, and its management is controversial. Classifications, such as the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS), are based on several clinical stages of CS. However, they are difficult to apply to an individual situation, as most patients go through the different stages with treatment.

CS is not uncommon and is not always caused by myocardial ischaemia

CS occurs in 5–15% of acute coronary syndromes (ACS) [4], involving approximately 40–50,000 patients/year in the USA and about 60–70,000 patients/year in Europe [5].

ACS and their complications are the cause of >60% of CS cases. However, the rate of non-ischaemic causes (acute myocarditis, acute intoxications, acute onset of cardiomyopathies or the late evolution of the underlying heart disease) has probably been underestimated [6, 7].

Data from registries including patients with CS caused by ACS are important, and may help to change clinical practice by highlighting the importance of a network organization. There are few data on CS resulting from non-ACS causes; small series have been published on CS caused by dilated cardiomyopathies, post-cardiac arrest shock and terminal heart failure [8]. Extrapolating results obtained in patients with CS caused by an ACS to CS resulting from other causes is hazardous.

Hence, there is an obvious need for contemporary epidemiological data from large cohorts, long-term follow-up and evidence-based strategies reducing short- and long-term mortality rates.

Therapeutic uncertainties and poor prognosis

Aissaoui et al. reported a reduction in short- and long-term mortality rates as a result of CS caused by ST-segment elevation myocardial infarction (STEMI) in the FAST-MI registries [6]; this was probably the result of an increase in the rate of early revascularization and improvements in antithrombotic therapies [6, 9].

Despite a strong and continuous interest in CS physiopathology and treatment, its management remains a matter of debate and is generally disappointing. To date, revascularization is the only treatment that has demonstrated its effectiveness in the management of CS caused by an ACS. Early revascularization also decreases the occurrence of CS during an ACS [1, 10, 11, 12]; however, its benefit is not always immediate. The SHOCK trial failed to demonstrate a superior effect of revascularization on mortality rates compared with medical treatment at 30 days. However, a significant difference in favour of revascularization was found at 6-month and 5-year follow-up.

Treatments such as inotropes, vasopressors, diuretics, invasive mechanical ventilation and cardiocirculatory support have largely failed to improve survival or quality of life convincingly [5, 13, 14, 15].

As for patients with chronic heart failure, who are better managed by specialized heart teams, patients with CS are at the crossroads of several specialties; they should be managed as soon as possible by a team that includes cardiologists, intensive care specialists and cardiac surgeons. The CS team will make the best use of specialized clinical and technical expertise, combining coronary angiography and coronary revascularization, electrophysiology, cardiocirculatory support, cardiac surgery and intensive cardiac care units. The aim is to optimize management by tailoring it to patient characteristics (age, co-morbidities, etc.). Knowledge is the key to improve organization and collaboration between different specialties with the patient at the centre [16, 17].

Lack of homogeneous and robust recommendations

Many expert consensus statements have been published on CS management [2, 17, 18, 19, 20], but European [21] and American [22] societies have presented only low-level of evidence recommendations based on just a few randomized and small-sized studies. Clinicians therefore refer to expert proposals and consensuses based on CS registries of varying sizes, but almost exclusively of ischaemic origin.

An example illustrating the limitations of the expert consensus is the intra-aortic balloon pump (IABP). This device has been used since the 1960s, based on an appealing pathophysiological concept. The European guidelines in 2008 strongly recommended the use of the IABP (class I, level C), but this recommendation was revised downwards to class IIb, level C in 2012 [23], and finally to class III, level B in 2014, based on reanalysis of the available data [24]. This last statement was confirmed recently in 2016 [21], following the publication of the landmark IABP-SHOCK2 study [25, 26].

Need for more clinical data

To date, the gap in knowledge is significant. There is an acute need to validate common therapeutics, and to assess new drugs and cardiocirculatory support. Ideally, this should be done through large prospective randomized studies, but they are exceedingly difficult to conduct in this setting. Most studies (Table 1) are small, and encounter difficulties with recruitment. Moreover, with such high mortality rates related to multiple factors [27], demonstrating a survival benefit is a huge challenge.

Challenges for clinical studies are high: heterogeneity of the studied populations and the mechanisms or stages of the CS; undersized populations; and uncertainties and difficulties in defining the severity of the enrolled patients [5].

For instance, the Impella® cardiocirculatory system (Abiomed Inc., Danvers, MA, USA), which has been available for almost 10 years, is appealing, especially because of the effective left ventricular discharge and cardiac output obtained (up to 5 L/min). However, this device has not demonstrated its effectiveness, probably because of difficult recruitment in randomized studies (Table 2). The Impella CP® (Abiomed Inc., Danvers, MA, USA) has recently been introduced, and is an interesting device, because it delivers up to 4 L/min of flow and can be placed percutaneously. Nonetheless, this device failed to demonstrate better survival compared with the IABP in post-cardiac arrest CS patients with an ACS [28]. New cardiocirculatory support devices are regularly proposed, including the iVAC 2.0® (Terumo, Shibuya, Tokyo, Japan) and the HeartMate PHP® (Thoratec Corp., Pleasanton, CA, USA). These devices are costly, and their benefit has still to be proved.

Pending the results of these studies, it is of the utmost importance to update and improve our knowledge of CS in real life through large contemporary registries. The FRENSHOCK registry (NCT02703038) is a French prospective multicentre register on CS regardless of initial aetiology. The aim of this large observational study is to assess the epidemiology and management of CS in France; it will describe the population, aetiologies, strategies and modalities of management, early (1 month) outcomes and late (1 year) outcomes. This registry may provide an important basis for organization, better management and clinical study design [29, 30].

The scientific community has to combine its forces through its human and financial resources in CS research, as it does in clinical practice, to improve knowledge and outcomes. The FRENSHOCK registry paves the way for further collaborative works in the field.

Funding

None.

Disclosure of interest

The authors declare that they have no competing interest.

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