ANMCO POSITION PAPER Role of Intra-Aortic Balloon

European Heart Journal Supplements (2021) 23 (Supplement C), C204–C220
The Heart of the Matter

doi:10.1093/eurheartj/suab074
ANMCO POSITION PAPER: Role of intra-aortic balloon
Downloaded from https://academic.oup.com/eurheartjsupp/article/23/Supplement_C/C204/6357813 by guest on 26 August 2021

pump in patients with acute advanced heart failure
and cardiogenic shock
Roberta Rossini1*(Coordinator), Serafina Valente2(Coordinator),
Furio Colivicchi3(Coordinator), Cesare Baldi4, Pasquale Caldarola5,
Daniela Chiappetta6, Manlio Cipriani7, Marco Ferlini8, Nicola Gasparetto9,
Rossella Gilardi10, Simona Giubilato11, Massimo Imazio12, Marco Marini13,
Loris Roncon14, Fortunato Scotto di Uccio15, Alberto Somaschini16,
Carlotta Sorini Dini17, Paolo Trambaiolo18, Tullio Usmiani12,
Michele Massimo Gulizia19,20, and Domenico Gabrielli (Coordinator)21
1
Division of Cardiology, Emergency Department and Critical Areas, Azienda Ospedaliera Santa Croce e Carle, Via
Michele Coppino 26, 12100 Cuneo, Italy
2
Clinical-Surgical-CCU Cardiology Department, Azienda Ospedaliero-Universitaria Senese Ospedale Santa Maria alle
Scotte, Siena, Italy
3
Clinical and Rehabilitation Cardiology Department, Presidio Ospedaliero San Filippo Neri—, ASL Roma 1, Roma, Italy
4
Interventional Cardiology-Cath Lab Department, Azienda Ospedaliera Universitaria San Giovanni di Dio-Ruggi
d’Aragona, Salerno, Italy
5
Cardiology-CCU Department, Ospedale San Paolo, Bari, Italy
6
Division of Cardiology, Ospedale Annunziata, Cosenza, Italy
7
Cardiology 2-Heart Failure and Transplants, Dipartimento Cardiotoracovascolare “A. De Gasperis”, ASST Grande
Ospedale Metropolitano Niguarda, Milano, Italy
8
Division of Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
9
Division of Cardiology, Ospedale Ca’ Foncello, Treviso, Italy
10
Department of Cardiac Surgery, ASST Grande Ospedale Metropolitano Niguarda, Milano, Italy
11
Cardiology-CCU –Cath Lab Department, Azienda Ospedaliera Cannizzaro, Catania, Italy
12
Division of Cardiology, Presidio Molinette, A.O.U. Città della Salute e della Scienza di Torino, Torino, Italy
13
Cardiology-CCU –Cath Lab Department, Azienda Ospedaliero-Universitaria Ospedali Riuniti, Ancona, Italy
14
U.O.C. Cardiologia, Ospedale Santa Maria della Misericordia, Rovigo, Italy
15
Cardiologia-UTIC-Emodinamica, Ospedale del Mare, Napoli, Italy
16
Department of Cardiology and Cardiac Intensive Care Unit, Ospedale San Paolo, Savona, Italy
17
Cardiology-CCU -Department, Ospedali Riuniti, Livorno, Italy
18
Cardiology-ICU Department, Presidio Ospedaliero Sandro Pertini, Roma, Italy
19
Cardiology Department, Ospedale Garibaldi-Nesima, Azienda di Rilievo Nazionale e Alta Specializzazione
“Garibaldi”, Catania, Italy
20
Fondazione per il Tuo cuore—Heart Care Foundation, Firenze, Italy; and
21
Cardiology Unit, Cardiotoracovascular Department, Azienda Ospedaliera San Camillo Forlanini, Roma, Italy
*Corresponding author. Tel 00390171642870, Email: roberta.rossini2@gmail.com
Published on behalf of the European Society of Cardiology. VC The Author(s) 2021.
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ANMCO Position Paper C205
KEYWORDS The treatment of patients with advanced acute heart failure is still challenging.
Advanced heart failure; Intra-aortic balloon pump (IABP) has widely been used in the management of
Cardiogenic shock; patients with cardiogenic shock. However, according to international guidelines, its
Intra-aortic balloon pump; routinary use in patients with cardiogenic shock is not recommended. This recom-
Mechanical Circulatory Support mendation is derived from the results of the IABP-SHOCK II trial, which demonstrated
(MCS)
that IABP does not reduce all-cause mortality in patients with acute myocardial in-
farction and cardiogenic shock. The present position paper, released by the Italian
Association of Hospital Cardiologists, reviews the available data derived from clinical
studies. It also provides practical recommendations for the optimal use of IABP in

the treatment of cardiogenic shock and advanced acute heart failure.
The external machine is composed of a console, a balloon

State of the art and guideline inflation pump, and a helium cylinder. The console allows
recommendations to control and adjust the haemodynamic parameters. The
pump is capable to rapidly inflate and deflate the balloon
Historical background synchronously with the cardiac cycle with a predetermined
The concept of ‘counterpulsation’ indicates the pumping volume of gas (30–50 mL of helium). The sizing of the bal-
of blood outside the canonical phases of the physiological loon should be carefully chosen before placement accord-
heart cycle 12 This method was first applied in experimen- ing to the anthropometric characteristics of the patient so
tal animals by Adrian and Arthur Kantrowitz in 1952 .2 Six that, when inflated, the balloon will fill 80–90% of the aor-
years later Harken proposed an extracorporeal pump able tic diameter.2 The dedicated double-lumen (one lumen is
to remove the blood during the systole and re-infuse it for helium and the other for invasive pressure measure-
quickly during the next diastole. However, only in 1961, he ment) balloon catheter can have a diameter varying be-
developed the first model of extracorporeal counterpulsa- tween 7 and 9.5 Fr.
tion. The initial clinical results were poor due to several The catheter can be easily inserted, either percutane-
issues, such as complications related to arterial accesses ously or surgically, through the femoral artery (only in se-
(bilateral arteriotomy was required), massive haemolysis lected cases by the brachial artery) and is advanced until it
due to blood turbulence, and poor synchronization of the reaches the correct position in the descending thoracic
pump with the cardiac cycle.3 In the same year, aorta. For proper positioning, the distal tip of the catheter
Moulopoulos et al.4 developed an intra-aortic device which should be placed about 2–3 cm below the origin of the left
consisted of a catheter with a balloon placed in the aorta, subclavian artery with the proximal extremity of the bal-
inflating during left ventricular diastole and deflating in loon above the origin of the renal arteries. The insertion
systole. The first clinical experience was described in 1968 manoeuvre requires about 20–30 min, it should be done un-
by Kantrowitz et al.5 who reported the benefits observed der fluoroscopic guidance, and it may take place at the
in two patients with cardiogenic shock (CS), in terms of in- bedside.
creased systemic blood pressure (BP) and urinary output, Intra-aortic balloon pump remains the simplest, cheap-
although only one patient survived till hospital discharge. est, most studied, and utilized MCS device and still repre-
At that time, device insertion required a surgical approach, sents the standard device in randomized clinical trials
which made the incidence of ischaemic vascular complica- aiming to evaluate the safety and efficacy of new mechani-
tions remarkably high. Notably, catheters had a diameter cal circulatory support systems.7 However, its use in recent
of 15 Fr. Due to these limitations, the indication was lim- years has seen a progressive reduction.8
ited to end-stage heart failure. In 1980, Bregman et al.6
first described the insertion of intra-aortic balloon pump
(IABP) catheter with a percutaneous approach in 25 Physiological principles of counterpulsation
patients, which led to a remarkable reduction in the rate
of complications and a significant increase in its use. Since The hydraulic model used for the description of the circula-
then, smaller balloon-catheter systems were developed tory system is known as the Windkessel model or ‘fireman’s
(e.g. ‘sheathless’ technique or ‘low-profile” catheters), model’. The similarities between the two systems include
along with more efficient control systems able to adapt the ability to transform a pulsating flow generated by a pul-
IABP to different haemodynamic and heart rhythm condi- sating pump (the heart) into a continuous flow (in the ves-
tions. These developments allowed to further improve sels), considering the aorta as an elastic conduit. Thus, the
counterpulsation techniques and reduce complications. circulatory system is conceived as an elastic central reser-
voir into which the heart pumps its content and from which
the various tissues extract blood through non-elastic con-
The intra-aortic balloon pump duits. Therefore, ventricular-arterial coupling plays a key
The IABP is the first and simplest mechanical circulatory role in the normal function of the cardiopulmonary circula-
support (MCS) device developed, which consists of an ex- tion. It is fundamental that the ‘heart system’ be ade-
ternal machine connected to the balloon-catheter system. quately paired with the ‘vessels system’ in order to
C206 R. Rossini et al.
maintain a cardiac output able to ensure adequate tissue the isovolumetric contraction) and must remain deflated
perfusion. during the entire duration of the systole.
Coronary flow is directly proportional to the perfusion The overall haemodynamic effects of IABP therapy are
gradient and inversely proportional to the coronary resis- summarized in Figure 1. Specifically, the systolic reduction
tance. It occurs mostly during diastole, and the driving in aortic pressure and volume generates the following
pressure gradient is generated by the difference between consequences:
the mean diastolic pressure in the aortic root and the mean
right atrial pressure. For this reason, the diastolic arterial • a reduction in LV afterload with a resulting reduction
pressure determines the pressure at which the coronary ar- in the myocardial consumption of oxygen
teries are filled and the coronary arteries perfusion pres- • a more favourable balance between myocardial con-
sure is usually around 50 mmHg. sumption and supply of oxygen and thus reduction of

The impact of counterpulsation is primarily due to an in- ischaemia
crease in the myocardial oxygen supply/demand ratio. This • a reduction in peak systolic pressure due to LV work-
result is achieved through both a reduction in the afterload load reduction
of the left ventricle (LV) and an increase in coronary perfu- • an increase in cardiac output and ejection fraction
sion in order to increase LV performance. Hence, the cou- • an improvement in the mechanical efficiency of the
pling between the left ventricle and the arterial system is left ventricle in terms of contractility (due to the left-
promoted, that is of utmost importance in the setting of CS ward shift of the pressure-volume curve).
where a reduced ventricular elasticity (contractility) and
an increase in arterial elasticity (after-load) are present.
The mechanism of counterpulsation is based on LV after- Advanced heart failure: the dimensions of
load modulation through the dislocation of a certain vol- the problem
ume of blood in diastole with an increase in aortic pressure
and its ‘restitution’ in systole with a decrease in aortic Definition and grading of cardiogenic shock
pressure. Of note, the displacement of blood due to bal- Cardiogenic shock is a clinical condition characterized by
loon inflation is directed both towards the top (coronary ar- hypotension and hypoperfusion due to the inability of the
teries and supra-aortic trunks) and the bottom (renal heart to provide adequate cardiac output in presence of
arteries and peripheral circulation) of the balloon. normal volemic status.9 Definitions of CS utilized in clinical
In order to allow proper functioning, the system requires trials and international guidelines are similar despite not
that the balloon inflates during the cardiac diastole—im- completely uniform. Several clinical elements are con-
mediately after the closing of the aortic valve—and stantly present across definitions: persistent hypotension
deflates during the systole (i.e. the concept of ‘counter- (systolic blood pressure <90 mmHg) unresponsive to vol-
pulsation’). The volume shift induced by the balloon infla- ume load and signs of end-organ hypoperfusion such as al-
tion increases the volume of blood present in the aortic tered mental status, cold extremities, and oliguria (urinary
arch and its pressure. Afterwards, the balloon must be rap- output < 30 mL/h). Another essential parameter is hyper-
idly deflated immediately preceding the systole (during lactacidaemia (lactate > 2.0 mmol/L), a specific
Figure 1 Haemodynamic effects of intra-aortic balloon pump. LVEDP, left ventricular end-diastolic pressure.
Table 1 Definition of advanced heart failure

Stages of cardiogenic shock (SCAI CONSENSUS DOCUMENT)
Stage A At risk A patient who is not currently experiencing signs or

symptoms of CS, but is at risk for its development.
These patients may include those with large acute
myocardial infarction or prior infarction acute and/or
acute on chronic heart failure symptoms.
Stage B Beginning cardiogenic shock A patient who has clinical evidence of relative hypoten-
sion or tachycardia without hypoperfusion.

Stage C Classic cardiogenic shock A patient that manifests with hypoperfusion that
requires intervention (inotrope, pressure or mechani-
cal support, including ECMO) beyond volume resusci-
tation to restore perfusion. These patients typically
present with relative hypotension.
Stage D Deteriorating or Doom A patient that is similar to category C but are getting
worse. They have failure to respond to initial
interventions
Stages E Extremis A patient that is experiencing cardiac arrest with ongo-
ing CPR and/or ECMO, being supported by multiple
interventions
ABP-shock II ESC SCAI
• Systolic blood pressure <90 mmHg for • Systolic blood pressure <90 mmHg in • Systolic blood pressure <90 mmHg o
at least 30 min or need for catechol- the presence of adequate volume. MAP < 60 mmHg of pressure drop >
amine infusion to support systolic blood • Cold extremities, oliguria, impaired 30 mmHg compared to baseline and ino-
pressure >90 mmHg sensory, dizziness, hyposphygmic tropes o device used to maintain a pres-
• Pulmonary congestion wrists. sure above these target.
• Hypoperfusion (impaired sensory, diure- • Metabolic acidosis, elevate serum lac- • Impaired sensory, oliguria < 30 mL/h,
sis <30 mL/h, cold extremities or lactate values, elevate blood creatinine volume overload, need for Bipap or me-
tates > 2.0 mmol/L) values chanical ventilation
• Lactates > 2.0 mmol/L, creatinine val-
ues doubled or, GFR halved, BNP high
value
biochemical marker of tissue hypoperfusion. Low cardiac of CS in five stages from A (‘at risk’) to E (‘extremis’) and
index (<2.2 L/min/m2) and high values of wedge pres- providing an accurate description of clinical signs, bio-
sure (>15 mmHg) are haemodynamic parameters that markers, and haemodynamic parameters for each stage12
can contribute to define and characterize CS but are not (Table 1).
essential for diagnosis.10 In the setting of CS, clinical and
haemodynamic features have a variable spectrum of pre-
sentation, from mild hypoperfusion to refractory CS, and Definition of advanced heart failure
the outcome is directly related to the severity of clinical Advanced heart failure [Stage D in the American College of
presentation. Cardiology/American Heart Association classification
Impending shock is a condition characterized by the (ACC/AHA)] is characterized by persistent signs and symp-
presence of systolic blood pressure <100 mmHg, cardiac toms of heart failure despite the optimization of medical,
rate at the upper range, normal lactate values, cardiac in- surgical, and device therapy. Some coincident parameters
dex 2.0–2.2 L/min/m2 and need for one low dose inotrope/ can be found in both ACC and European society of
vasoactive drug. In overt CS these pathological alterations Cardiology (ESC) definitions of advanced heart failure such
become more evident while in refractory CS they become as symptoms, number of heart failure hospitalization be-
severe with systolic blood pressure <90 mmHg, cardiac fore index hospitalization, signs of end-organ dysfunction.
rate > 120 beat/min, obtunded mental status, lactate val- Conversely, other parameters are reported only in one of
ues > 4 mmol/L, cardiac index < 1.5 L/min/m2, and need the one definitions, such as intolerance to beta-blockers,
for two or more vasoactive drugs.11 A clinical consensus Implantable Cardioverter Defibrillator (ICD) shocks, EF <
statement on CS was published by the Society for 30%.13,14 The INTERMACS society (Interagency Registry for
Cardiovascular Angiography and Interventions (SCAI) in Mechanically Assisted Circulatory Support) proposed a clas-
2019, proposing an intuitive and innovative classification sification made by seven stages characterized by
Table 2 Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) classification for patients with advanced
heart failure
INTERMACS stages for classifying patients with advanced heart failure
INTERMACS 1 • Cardiogenic shock Haemodynamic instability in spite of increasing doses of cate-

• ‘Crush and burn’ cholamines and/or mechanical circulatory support with critical
hypoperfusion of target organs (severe cardiogenic shock).
INTERMACS 2 Progressive decline despite inotropic sup- Intravenous inotropic support with acceptable blood pressure but
port ‘Sliding on inotropes’ rapid deterioration of renal function, nutritional state, or signs
of congestion.

INTERMACS 3 • Stable but inotrope dependent Haemodynamic stability with low or intermediate doses of ino-
• ‘Dependent stability’ tropics, but necessary due to hypotension, worsening of symp-
toms, or progressive renal failure.
INTERMACS 4 • Resting symptoms Temporary cessation of inotropic treatment is possible, but pa-
• ‘Frequent flyer’ tient presents with frequent symptoms recurrences and typi-
cally with fluid overload
INTERMACS 5 • Exertion intolerant Complete cessation of physical activity, stable at rest, but fre-
• ‘Housebound’ quently with moderate fluid retention and some level of renal
dysfunction
INTERMACS 6 • Exertion limited Minor limitation on physical activity and absence of congestion
• ‘Walking wounded’ while at rest. Easily fatigued by light activity
INTERMACS 7 ‘Placeholder’ Patient in NYHA Class III with no current or recent unstable fluid
balance.
progressively (from 7 to 1) more severe clinical and haemo- In the late 90s, the SHOCK (Should We Emergently
dynamic profiles. INTERMACS classification is used world- Revascularize Occluded Coronaries for Cardiogenic Shock)
wide in both for clinical and scientific purposes15 (Table 2). trial highlighted the positive impact of early revasculariza-
tion on long-term outcomes in patients with AMI compli-
cated by CS.20 As a consequence, more patients now
Epidemiology survive to AMI increasing the number of patients with resid-
Cardiogenic shock is mainly due to acute myocardial infarc- ual advanced heart failure, at risk for developing CS.
tion (AMI) complicated by left ventricle dysfunction (80%)
followed by mechanical complications of myocardial in-
Prompt diagnosis
farction (13%). Myocarditis, cardiomyopathies, and electri-
A prompt identification of signs and symptoms of hypoper-
cal storm account for the remaining 7% of cases.16 CS
fusion is crucial in patients with advanced heart failure,
complicates AMI in 5–8% of cases, with an incidence of 40
without overt CS, in order to prevent multi-organ failure
000–50 000 patient/year in the United States and 60 000–70
refractory to any treatment. For this reason, the search for
000 patient/year in Europe17. Recent data from a network
the aetiology of acute advanced heart failure and CS should
of North American intensive care units showed a substan-
proceed in parallel with its treatment. The main objective
tial modification in the epidemiology of CS due to an in-
of CS treatment is the maintenance of adequate tissue per-
crease of non-ischaemic aetiology (28%) and ischaemic
fusion and, when feasible, unloading of the LV and improv-
aetiology nonrelated to AMI (18%) and a decrease of CS
ing of coronary perfusion. In all cases of CS complicating
complicating myocardial infarction (30%).18 Notably, the
AMI, an adequate pharmacological (inotropes and vaso-
number of patients at risk of CS is constantly increasing due
pressors), ventilatory and, if needed, mechanical support
to progressive aging of the population and growing inci-
should be provided in addition to myocardial revasculariza-
dence of coronary artery disease and heart failure, as
tion, in order to maintain an adequate perfusion10 (Figure
highlighted by a large Swedish register of 3,654 patients
2). The presence of a ‘shock team’ is fundamental to man-
with CS due to AMI hospitalized in the period 1995–2013.19
age these complex patients. The shock team should not be
The early mortality of CS is still elevated despite the pro-
intended as a 24/7 available team, but rather as a model of
gresses made in medical therapy, coronary revasculariza-
management, a sort of diagnostic-therapeutic protocol ap-
tion techniques, and MCS devices. Thus, CS remains an
plicable also in spoke hospitals. (Figures 3 and 4).
unsolved clinical problem with a high rate of in-hospital
mortality which has not significantly decreased over the
last three decades. The lack of progress in terms of the out- Guideline recommendations
come can be explained considering the increasing complex- ACC/AHA guidelines for ST-elevation myocardial infarction
ity and risk profile of CS patients in the last years. Indeed, (STEMI) of 2004 assigned to IABP use in CS due to AMI a
these patients frequently show an advanced age, previous Class I, level of evidence B recommendation.21 In the fol-
coronary events, and often a severe LV systolic dysfunction. lowing update of the same guidelines the recommendation
In-hospital
In-hospital
CABG, coronary artery by-pass grafting; IABP, intra-aortic balloon pump; LVAD, left ventricular assist devices; NA, not available; NS, non-significant; PCI, percutaneous coronary intervention; RCT, randomized
Follow-up
6 months
30 days
30 days
30 days
30 days
30 days
4 days
Significant reduction
Result

NS
NS
NS
NS
NS
NS
Figure 2 Targets in the treatment of cardiogenic shock. CABG, coronary
artery bypass graft; ECMO, extracorporeal membrane oxygenation; IABP,
Primary endpoint
intra-aortic balloon pump; LV, left ventricle; P, pressure; MAP, mean arte-
APACHE II score
Total mortality
Total mortality
Total mortality
Total mortality
Total mortality
Total mortality
Total mortality
Total mortality
rial pressure; PCI, percutaneous coronary intervention; V, volume.
was weaker (Class IIa, level of evidence B).22 Similarly,

IABP use in patients with haemodynamic instability or CS
was recommended in Class I (level of evidence C) in the
2008 ESC STEMI guidelines23 and 2010 ESC guidelines on
No IABP/LVAD
IABP post PCI
myocardial revascularization.24 Afterwards, in 2012 ESC

Control
STEMI guidelines IABP received a class IIb recommenda-

No IABP
No IABP
No IABP
No IABP
No IABP
No IABP
No IABP
tion.25 After the publication of IABP-SHOCK II trial,16 rou-

tine use of IABP in CS was downgraded to a Class III
recommendation both in 2014 and 2018 guidelines on myo-
Clinical studies regarding the use of IABP in cardiogenic shock complicating acute myocardial infarction
No reperfusion/TL/PCI
cardial revascularization26 and in 2017 STEMI guide-

lines.27,28 Nonetheless, a Class IIa recommendation was
Treatment
left in case of mechanical complications after AMI. The pro-

PCI/TL/CABG
gressive downgrading of routine IABP use in CS may have

Failed PCI
PCI/CABG
numerous consequences. First, a decrease in IABP use in

clinical practice. Second, the need for cardiologists who
PCI
PCI
PCI
still use this device for CS to motivate their choice from a

TL
TL
legal perspective. Lastly, IABP could disappear as a stan-

Shock definition
dard therapy (control arm) in randomized clinical trials

Hypotension
Hypotension
Hypotension
Hypotension
Hypotension
aiming to evaluate other MCS devices in the setting of CS.
Intra-aortic balloon pump contexts of use beyond

NA
NA
NA
NA
cardiogenic shock
Since IABP was introduced in clinical practice, it has been
STEMI
100%
100%
100%
65%
81%
65%
69%
NA
NA
control trial; STEMI, ST elevation myocardial infarction; TL, thrombolysis.
used in several contexts in addition to CS (Figure 5).
• Cardiogenic shock complicating myocardial infarc-

Patients (n)
tion: in the thrombolytic era, IABP was mainly

implanted in patients with haemodynamic instability
1009
48
790
991
10529
14186
600
57
40
or CS with overall favourable results in registries or

small randomized trials.29,30 In the 1990s, IABP use
was so widespread that in the SHOCK trial20 86% of
Prospective registry
patients with CS complicating myocardial infarction

Retrospective
Meta-Analysis
Meta-Analysis
Meta-Analysis
Meta-Analysis
were implanted with this device. In the following

Design
years, the era of primary percutaneous coronary in-

tervention (pPCI), registries and trials showed no
clear advantages in patients supported with IABP.31,32
RCT
RCT
RCT
In 2012 the IABP SHOCK II trial, the larger trial ever

conducted on this topic, showed no improvement in
Abdel-Wahab et al.60
Prondzinsky et al.56
outcome in patients who received IABP with a deep

Unverzagt et al.35
Hawranek et al.41
IABP-SHOCK II16
impact on following meta-analyses and international

Ohman et al.31
Romeo et al.63
Sjauw et al.57
Sjauw et al.57
guidelines.33,34
• Myocardial infarction without CS: despite the undis-
Table 3
puted advantages of PCI, a small percentage of

Study
patients affected by myocardial infarction and treated

with PCI still experience ‘no-reflow’, a phenomenon

Figure 3 The Shock Team. BP, blood pressure; C, cardiologist; CABG, coronary artery bypass graft; HS, heart surgeon; ECMO, membrane extracorpo-
real oxygenation; IABP, intra-aortic balloon pump; PCI, percutaneous coronary intervention; ER, emergency room; CVP, central venous pressure; I, inten-
sivist; SVO2, venous oxygen saturation; ICU, intensive care unit; ED, emergency medicine doctor; CICU, cardiological intensive care unit.
Figure 4 Cardiogenic shock management protocol. CS, cardiogenic shock; BP, blood pressure; DO, differential diagnosis; IABP, intra-aortic balloon
pump; PCI, percutaneous coronary intervention; ACS, acute coronary syndrome.
caused by a multifactorial mechanism.35 In this con- implantation before PCI could reduce infarct size evalu-
text, the prophylactic use of IABP has shown advan- ated by cardiac magnetic resonance in patients with an-
tages both in experimental studies 36 and in a large terior STEMI without CS. In this trial, the primary end-
registry of 1500 high-risk patients undergoing primary point was not reached,38 thus discouraging the use of
PCI.37 The randomized trial CRISP-AMI (Counterpulsa- IABP in this context. Nevertheless, a recent small ran-
tion to Reduce Infarct Size Pre-PCI Acute Myocardial domized trial showed a non-significant survival benefit
Infarction), was designed to assess whether IABP and a significant improvement in ST-segment resolution in
adverse cardiovascular events at 30 and 90 days in

patients implanted with IABP.46
• Peri-operative care in cardiac surgery: the implanta-
tion of IABP before cardiac surgery in selected high-
risk patients with LV dysfunction can reduce low flow
syndrome/perioperative complications and intensive
care length of stay.47,48
• Refractory ventricular arrhythmias: the use of IABP as
a mechanical support system in patients with LV dys-
function and sustained ventricular arrhythmias refrac-
tory to medical therapy has limited evidence. Goyal

et al.49 described the efficacy of IABP in the treat-
ment of refractory ventricular arrhythmias in a pa-
tient with dilated cardiomyopathy and normal
coronary arteries. Fotopoulos et al.50 suggested in
these patients an indirect beneficial mechanism medi-
ated by the reduction of the adrenergic tone and
therefore myocardial vulnerability to arrhythmias.
• Left ventricle unloading during veno-arterial extra-
corporeal membrane oxygenation (VA ECMO) support:
Figure 5 Contexts intra-aortic balloon pump of use. IABP, intra-aortic IABP reduces the afterload, thus it can be used as an
balloon pump; LV, left ventricle; VA-ECMO, veno-arterial extra-corporeal unloading system of the LV during percutaneous VA-
membrane oxygenation; PCI, percutaneous coronary intervention. ECMO.51
the IABP group.39 In a recent prospective registry, Hawra-

nek et al.40 assessed the impact of IABP use in patients Intra-aortic balloon pump in cardiogenic
with myocardial infarction complicated by CS according shock: a critical appraisal of the literature
to the success of revascularization evaluated with final
TIMI flow. Among patients with unsuccessful PCI (TIMI Intra-aortic balloon pump is available since 1968, and it has
flow 0/1), those supported with IABP showed a significant been the most used MCS device in the last 40 years. Its
lower 30-day mortality and 1-year mortality. wide use has been in part related to the Class I recommen-
• High-risk PCI: IABP has been used to prevent complica- dation set in the previous European and American guide-
tions in patient undergoing high-risk PCI (defined lines,52 despite a level of evidence of C and B respectively
according to clinical, haemodynamic, and anatomical due to the small sample size of the supporting studies
criteria). The first clinical experiences in this context (mostly observational). In two small, randomized clinical
showed positive results , whereas the randomized trial studies in patients with AMI but without CS, IABP did not
Balloon Pump Assisted-Coronary Intervention Study improve clinical outcomes and LV ejection fraction (EF)
(BCIS) showed controversial results. In this study, 150 compared with medical therapy.53,54 However, in patients
patients received IABP before high-risk PCI and with anterior AMI without CS undergoing successful PCI,
showed no benefit in terms of in-hospital and 6-month the use of IABP reduced the rate of re-occlusion of the in-
mortality and ischaemic cardiac or cerebral events farct-related artery with a non-significant improvement of
compared with control group.0,41 Conversely, 2-years LVEF.55 In a randomized study including 57 patients with ST-
follow-up data showed a relative 34% decrease of all- elevation myocardial infarction (STEMI) and arterial hypo-
cause mortality in the IABP group.42 In the last years, tension, the use of IABP in addition to thrombolytic therapy
other percutaneous MCS devices have been used in reduced mortality with a borderline statistical significance
high risk-PCI and practical algorithms for MCS device only in patients in Killip Classes III and IV. Furthermore, in
choice have been proposed.43 45 patients with STEMI complicated by CS undergoing pri-
• Non ischaemic CS and advanced heart failure: IABP mary PCI, the addition of IABP was associated with only
can be implanted in these patients as ‘bridge to deci- modest effects on the reduction of APACHE II score com-
sion’ or ‘bridge to bridge’ while waiting for cardiac pared with medical therapy alone.56 In a meta-analysis of
transplantation or left ventricular assist device (LVAD) nine studies (only three of which including patients treated
implantation.44 Several studies highlighted predictors with primary PCI), IABP use did not improve 30-day survival
of successful IABP use in this context.45 The first ran- or LVEF, and its use was associated with a significant in-
domized trial in this clinical scenario was recently crease in the rate of stroke and bleeding complications.57
published, comparing IABP with inotropes. The results However, all the aforementioned studies were not ade-
showed a significant improvement in the primary end- quately powered either to investigate an association be-
point (trend in venous oxygen saturation [SvO2] values tween IABP and mortality as a single Endpoint or to draw
at 3 h) and in other instrumental and laboratory definite conclusions. Moreover, the wider use of primary
parameters (cardiac power output, N-terminal frag- PCI in patients with STEMI58 either complicated by CS or
ment of the type-B natriuretic peptide) and a positive, not, warranted a randomized clinical trial focused on the
albeit non-significant, trend in the rate of major use of this device.
The IABP-SHOCK II16 trial was a multicentre, open-label In a recent prospective registry, Hawranek et al.40 inves-
study, that enrolled 600 patients with STEMI complicated tigated the efficacy of IABP in patients with AMI compli-
by CS undergoing planned early revascularization. Patients cated by CS according to the success of revascularization
were randomly assigned to receive IABP in addition to opti- evaluated with final TIMI flow. Since 2003 to 2014, more
mal medical therapy. At 30 days, mortality was not differ- than 7200 patients were included in the study. Patients
ent between IABP and control group [39.7% vs. 41.3%, treated with IABP presented lower systolic arterial pres-
respectively; relative risk 0.96; 95% confidence interval sure and LVEF, higher heart rate, rate of multivessel coro-
(CI) 0.79–1.17; P ¼ 0.69]. No differences were found be- nary artery disease, and involvement of left main and left
tween the two groups with respect to the rates of stroke, anterior descending artery. The use of IABP was associated
bleeding, peripheral ischaemic complications, recurrent with higher 30-day and 1-year mortality, recurrent MI,
AMI, and stent thrombosis. IABP-SHOCK II is currently the stroke, recurrent PCI, major bleeding, and cardiac arrest,

largest available randomized clinical trial investigating the due to the higher risk profile of patients treated with the
role of IABP in patients with AMI and CS, and the authors device. However, in patients with final TIMI flow 0/1, IABP
should be commended for their efforts. However, several use was an independent predictor of lower 30-days mortal-
study limitations are evident. First, only about 70% of the ity (HR 0.72, 95% CI 0.59–0.89; P ¼ 0.002) despite a higher
enrolled patients presented with STEMI and among these, rate of bleeding, recurrent MI and lower LVEF. Conversely,
more than a half with a non-anterior MI. Second, the timing in patients with final TIMI 2-3, IABP was an independent
of CS development has not been clearly reported, thus predictor of higher 30-day mortality (HR 1.18, 95% CI 1.08–
some CS cases may have experienced subacute presenta- 1.30; P ¼ 0.0004). Therefore, these hypothesis generating
tion. Third, IABP was implanted after PCI in 87% of the results might suggest a beneficial impact of IABP use in
cases, which is not coherent with a prompt treatment of CS patients with AMI complicated by CS undergoing PCI with a
and/or advanced acute heart failure. Forth, about 45% of final suboptimal angiographic result (TIMI 0–1 or no-
enrolled patients experienced a resuscitated cardiac arrest reflow). Table 316,30,34,40,56,57,60,63 summarizes the results
(36% of those were treated with therapeutic hypothermia). of the main studies on the use IABP in patients with MI com-
Fifth, the median duration of counterpulsation was 3 days plicated by CS.
(interquartile range 2–4), with more than half of deaths oc-
curring afterwards. Finally, 4.3% of patients enrolled in the Intra-aortic balloon pump vs. other percutaneous
IABP arm died before implantation and a cross-over from mechanical circulatory support devices in
control group to IABP group occurred in 30 cases. Of note, patients with ST-elevation myocardial infarction
the rate of LVAD implantation was higher in the control complicated by cardiogenic shock
group (22 vs. 11). In the intention-to-treat analysis, the Beyond IABP, the following percutaneous MCS (pMCS) devi-
mortality rate in the control group was 41.3%, far from the ces are currently available with different circuit
56% hypothesized by the authors for sample size calcula- configurations:
tion. Thus, the 8.8% absolute risk reduction obtained
R
(lower than the expected 12%) decreased statistical power • Left ventricle ! Aorta. ImpellaV 2.5 and CP
from 0.82 to 0.59. The results of IABP-SHOCK II trial have (Abiomed, Danvers, MA, USA) is approved for short-
been confirmed at 6 years follow-up. However, it should be term (7–14 days) support of the LV in patients with CS
underlined that according to these data about 60% of due to isolated LV dysfunction refractory to optimal
patients with CS have died despite contemporary treat- medical therapy.
ment with revascularization therapy.59 • Left atrium ! Aorta. TandemHeart, LivaNova London,
An important issue when considering the efficacy of IABP UK.
is the timing of insertion in relation to coronary angiogra- • Right atrium ! Aorta. VA-ECMO.
R
phy and PCI. It has been already reported that the insertion • Inferior vena cava ! Pulmonary artery. ImpellaV RP is
of IABP before PCI was associated with a significant reduc- approved for CS due to right ventricle failure.
tion in mortality and adverse cardiovascular events.60
Recently, a study including patients with CS due to differ- In the 65 patients with AMI complicated by CS enrolled in
ent aetiologies, confirmed that an early placement of IABP the ISAR-SHOCK (Efficacy Study of LV Assist Device to Treat
was an independent predictor of 30 days survival.61 Patients With Cardiogenic Shock)64 trial, the use of
R
In a subgroup analysis of the CRISP-AMI trial in patients ImpellaV 2.5 appeared safe, feasible, and associated with
with large anterior STEMI and persisting ischaemia after an greater circulatory support compared to IABP.
PCI, the use of IABP was associated with a significant mor- Nevertheless, overall 30 days mortality rate was elevated
tality reduction at 6 months.62 Conversely, an updated (46%) and did not differ between the two groups. The
meta-analysis of seven randomized studies (four comparing IMPRESS in Severe Shock (IMPella vs. IABP Reduces mortal-
IABP vs. medical therapy and three comparing IABP with ity in STEMI patients treated with primary PCI in Severe
other MCS devices) including patients with STEMI compli- cardiogenic Shock) trial included 48 patients with STEMI
cated by CS, did not find significant differences in 30-days complicated by severe CS (all treated with mechanical ven-
survival between the study groups.34 Subgroups analysis tilation, 92% with cardiac arrest and refractory shock at re-
showed a beneficial impact of IABP use on prognosis in turn of spontaneous circulation) and reported no
patients with young age, no prior MI, arterial hypertension, difference in mortality at 30 days and at 6 months between
and in case of anterior MI. patients who received either Impella or IABP.65 The rate of
R
major bleeding was higher in patients treated with Third, most patients were treated with ImpellaV 2.5, thus
R R
ImpellaV (33% vs. 8%, P ¼ 0.06). No difference on survival the results of the studies may not be applied to ImpellaV
and an increased risk of bleeding was confirmed in the 5.0 or CP. Finally, patients at higher risk who were initially
R
following registries comparing ImpellaV with the IABP in treated with IABP and subsequently required an escalation
patients with CS surviving a cardiac arrest.66 A collabora- to a more potent circulatory support have usually been ex-
tive meta-analysis of four randomized trials aiming at included. Therefore, data from randomized clinical trials
R
vestigating efficacy and safety of other pMCS devices comparing ImpellaV 5.0 or CP with IABP are urgently
(TandemHeartTM or ImpellaV) vs. IABP in CS reported no
R
needed.
difference in 30-day mortality. However, other pMCS In the recent IMPELLA-STIC,71 a small sample of patients
devices significantly increased median arterial pressure with AMI complicated by CS stabilized by initial treatment
R
and decreased arterial lactate levels. Furthermore, al- with inotropes was randomized to receive ImpellaV LP 5.0.

though no significant difference was observed in the in- The use of the device was not associated with an improve-
cidence of leg ischaemia, the rate of bleeding ment in LVEF, whereas it was associated with an increase in
complications was significantly increased in patients the rate of major bleeding at 1 month. The ongoing DanGer
treated with other pMCS devices compared with IABP.67 Shock72 trial randomizes patients with AMI complicated by
Schrage et al.68 performed a retrospective propensity-
R
CS on a 1:1 basis to ImpellaV CP or current guideline-driven
matched analysis comparing patients with MI compli- therapy. The planned enrolment of 360 patients will pro-
R
cated by CS managed with ImpellaV at several tertiary vide an adequate statistical power to investigate the pres-
care European hospitals with patients enrolled in the ence of an association between study treatment and
IABP-SHOCK II trial. The authors found no difference in survival in this clinical setting.
30-days mortality (48.5% vs. 46.4%, P ¼ 0.64). Notably, Veno-arterial extra-corporeal membrane oxygenation
R
the use of ImpellaV was associated with a significant in- has been mainly studied in the setting of STEMI, myocardi-
crease in severe or life-threatening bleeding (8.5% vs. 3.0%, tis, post-cardiotomy shock, and refractory cardiac arrest.
P < 0.01) and peripheral vascular complications (9.8% vs. However, data on VA-ECMO mainly derive from observa-
3.8%, P ¼ 0.01). Data from the National Cardiovascular Data tional data. Therefore, guidelines recommendation for its
Registry reported a significant increase over time in the use use are based only on experts opinion (Class IIb).
Retrospective data by Sheu et al.73 and Baek et al.74
R
of ImpellaV in patients with AMI complicated by CS undergo-
ing PCI: from 3.5% in 2015 to 8.7% in 2017. In the propensity- showed that an early use of VA-ECMO in patients with
matched analysis performed within this cohort, total mor- STEMI undergoing primary PCI complicated by refractory
R
tality was 45% in patients treated with ImpellaV and 34% in CS (defined as persistence of systolic blood pressure <
patients treated with IABP, while major bleedings were 75 mmHg despite the use of vasopressors and IABP) im-
more frequent in the first group (31.3% vs. 16%).69 Table 4 proved outcome at 30 days, with an overall mortality of
summarizes the main studies comparing Impella/ 43%. The use of the ENCOURAGE score based on 7 parame-
TandemHeart with IABP.64–68,70 ters [age > 60 years, female sex, body mass index > 25 kg/
It should be noted that previous results have been m2, Glasgow scale < 4, creatinine > 150 lmol/L, arterial
obtained from observational studies. Thus residual con- lactates (<2, 2–8, or >8 mmol/L) and prothrombin activity
founders cannot be excluded despite statistical adjust- <50%] before ECMO implantation might be a useful dis-
ment. Furthermore, several other study limitations should criminatory tool to predict mortality in patients with AMI
be considered. First, outcomes analysis has not been strati- complicated by CS evaluated for VA-ECMO.75 Lastly, a re-
fied for CS severity in the different studies. Second, it is cent retrospective study failed to show a significant differ-
likely that more severe patients with a higher risk of mor- ence in 30 days mortality in patients treated with VA-ECMO
or ImpellaV CP/5.0.36
R
tality have been treated with more complex pMCS devices.
Table 4 Studies comparing IABP vs. Impella/TandemHeart in patients with cardiogenic shock
Study Design Patients (n) Control Primary Endpoint Result Follow-up
Seyfarth et al.64 Randomized 26 Impella Cardiac Index Significant increase 30 min

with Impella
IMPRESS65 Randomized 48 Impella Mortality NS 30 days
Manzo-Silberman et al.66 Retrospective 78 Impella Mortality NS 30 days
Thiele et al.67 Mata-Analysis 148 Impella/ Mortality NS 30 days
TandemHeart
Schrage et al.68 Retrospective 372 Impella Mortality NS 30 days
propensity matched
Amin et al.70 Retrospective 48306 Impella Mortality Significant increase In-hospital
propensity matched with Impella
NS, not significant.

Figure 6 Choice of percutaneous mechanical assistance system in cardiogenic shock. IABP, intra-aortic balloon pump; VA ECMO, veno-arterial extracor-
poreal oxygenation to the arteria invenosus membrane; AMI acute myocardial infarction.
Practical recommendations on the use of no response to pharmacological therapy (espe-

intra-aortic balloon pump cially diuretics), oliguria, elevated HR, (SCAI
Classification Class A and B)]
ANMCO aimed at focusing the proper setting for which IABP b. AMI showing persistent ischaemia/no-reflow af-
use is adequate, thus bridging the gap between Class III rec- ter PCI, on top of standard therapy
ommendation28 and its wide use in clinical practice. It is of (2) AMI complicated by overt CS
utmost importance when selecting the proper percutane- a. AMI complicated by CS due to mechanical com-
ous MCS device, a thorough evaluation of both the patient plications (bridge to surgery)
and the degree of ongoing acute heart failure/CS (Figure b. AMI with partially successful/unsuccessful PCI as
6). The use of IABP should be considered in the very early initial device as a bridge to escalation to more
phases of CS and in patients with impending shock, espe- potent pMCS devices placement (bridge to
cially when other MCS are not available. Therefore, it is bridge) or LVAD placement/transplantation
crucial to timely identify patients who are at risk of devel- (bridge to decision)
oping CS (or in CS initial phase) searching for early signs of c. AMI complicated by CS when other pMCS devices
CS such as initial increase in lactate levels in a setting of or- are not available
gan hypoperfusion. d. AMI complicated by CS when other pMCS severe
An adequate set up of IABP functions is warranted, with aortic valvulopathy, severe peripheral artery
particular attention to balloon inflation and deflation tim- disease, . . .).
ing (Figure 7). (3) CS due to non-ischaemic aetiology:
On the basis of previous data, safety, and ease of use of a. heart failure with non-ischaemic aetiology at
IABP, together with lack of prompt availability of new pMCS high risk of developing CS (SCAI Classification
devices, we suggest the following practical recommenda- Class A); ‘pre-shock’ (MAP 65–70 mmHg and/or
tions for non-routinary use of IABP: SvO2/ScvO2 < 65–70%; normal lactates; cardiac
index 2–2.2 L/min/m2 with only one vaso-
(1) AMI with initial/impending CS: pressor/inotrope at low dosage) especially if
a. AMI in ‘Pre-shock’ state (MAP 65–70 mmHg and/ reversible cause are detected (bridge to
or SvO2/central venous saturation [ScvO2] < 65– recovery)
70% and/or lactate increase and/or cardiac in- b. patients with CS in the presence of contra-
dex 2–2.2 L/min/m2 with only one vasopressor/ indications to other pMCS devices placement
inotrope at low dosage) OR judged at high risk c. CS with non-ischaemic aetiology as initial device
of developing CS [signs of pulmonary congestion, before other pMCS devices placement (bridge to
Figure 7 Correct intra-aortic balloon pump setting with appropriate balloon inflation and deflation timing according to cardiac cycle. Downloaded from https://academic.oup.com/eurheartjsupp/article/23/Supplement_C/C204/6357813 by guest on 26 August 2021
bridge) or LVAD placement/transplantation (6) Ventricular arrhythmias refractory to pharmacolog-

(bridge to decision) ical treatment as ‘bridge to recovery’ or ‘bridge to
(4) Back-up system (sheath insertion in femoral artery treatment’ (ablation, LVAD, transplantation).
for rapid bail-out placement) in the context of (7) LV unloading in patients undergoing VA-ECMO.
high-risk PCI (Tables 5 and 6) based on clinical, ana-
tomical, and procedural criteria, especially in the
presence of contraindication for or unavailability of
Nursing care in the patients with an intra-aortic
other MCS devices.
balloon pump
(5) Perioperative setting use in cardiac surgery for
Nursing care in the patients with an IABP lasts for the dura-
high-risk patients to reduce peri-procedural com-
tion of IABP placement and consists of four steps:
plications and facilitate weaning from extra-
corporeal circulation. • Step 1: preparation of the patient for IABP placement
Table 5 Factors contributing to define high-risk PCI
Coronary artery disease Clinical features Haemodynamic aspects
• Multivessel disease Comorbidities and cardiological conditions • Left ventricular dysfunction

• Left main disease reducing tolerance to myocardial • Transient haemodynamic instability
• Chronic total occlusions ischaemia: • Advanced heart failure
• Extended revascularization • Advanced age
• No. of balloon/stent inflations • Diabetes mellitus
• Use of additional devices (i.e. rotablator) • Heart failure
• Peripheral vascular disease

Table 6 Main elements in the choice of the type of percutaneous mechanical assistance for high -risk PCI in the absence of signifi-
cant peripheral vascular disease
IABP IMPELLA ECMO
High risk of haemodynamic instability Very high risk of haemodynamic instability Very high risk of haemodynamic instability
with biventricular dysfunction
Echocardiographic aspect not relevant No ventricular thrombosis, no severe aor- Ventricular thrombosis, Severe aortic
tic valve disease valve disease
• Step 2: assistance to the physician during IABP • Tasks during IABP placement:
insertion • plug in the device
• Step 3: monitoring the patient with IABP • connect pressure and heart rate monitoring cables to
• Step 4: weaning phase and IABP removal the patient’s monitor (where available)
• monitoring patient’s vital parameters, level of con-
sciousness, cognition, and agitation
Step 1: preparation of the patient for intra-aortic bal- • co-operate with the physician for insertion and posi-
loon pump placement. tioning of the catheter
In this phase, the nurse prepares the patient for IABP inser- • co-operate with the physician in IABP connection and
tion, and: setting
• Cleans the groin area and, if necessary, perform tri- • remove all the utilized material once the catheter is
chotomy from the groin until the knee placed, with special attention to the sharps
• Talks to the patient (previously informed by the physi- • prepare a dressing at the insertion site
cian) and explains further details, if necessary • adjust the bed and the patient in a comfortable posi-
tion (always keep an inclination <30 )
Step 2: assistance to the physician during intra-aortic

balloon pump placement. Step 3: Monitoring the patient with intra-aortic bal-
The assistance for IABP placement includes both prepara- loon pump
tion of materials and direct assistance to the physician dur- In this phase, a prompt identification of early and late com-
ing insertion manoeuvre: plications of IABP is warranted.
• Gathering the material: Early complications.

• sterile sheets, gauzes and gloves, face masks, protec- It is important to monitor:
tive glasses;
• dressing and treatment trolley: disinfectant, sutures, • vital parameters (HR, BP, diuresis, peripheral satura-
local anaesthetic, various syringes; tion, fever) ensuring that the target values are
• pressure bag with saline solution (in some centres sa- reached and maintained. Reduction in urinary output
line solution is heparinized). refractory to diuretic therapy could be due to balloon
• Preparing the kit and the device: displacement, thus correct position should be
• check the completeness of the kit checked.
• predisposition of IABP device (check cables, helium • insertion site (percutaneous or surgical) and its dress-
tank filling level, correct tank position, and opening) ing, in order to promptly identify bleeding
• preparation of invasive blood pressure monitoring kit complications.
• proper IABP device functioning • Removal phase is a very delicate stage as the de-
• circuit integrity. In case blood is detected in the con- flated balloon cannot pass through the sheath and,
necting pipe between IABP and the catheter, IABP thus, must be removed together with the sheath re-
should be immediately stopped and the physician quiring careful attention to vessel haemostasis.
informed.
• level of the battery. IABP is usually plugged.
Nevertheless, the patient may need to be moved to Conclusion
undergo diagnostic test. Thus, batteries should be
kept fully charged and must be able to provide ade- Prognosis of patients with acute advanced heart failure and
quate power supply. CS is still poor in spite of coronary reperfusion. A prompt di-
• helium tank residual capacity. Check the helium tank

agnosis of multi-organ hypoperfusion and therapeutic in-
light when starting to use the device and subsequently tervention aimed at restoring an adequate arterial
perform daily check. pressure is crucial. The neutral results of the IABP-CHOCK II
• daily coagulation tests, especially if patient is treated with trial might be related to a late IABP implantation, which
anticoagulant therapy (such as unfractioned heparin). occurred in the vast majority of cases after PCI. It seems
• peripheral pulses, colour, and temperature of the limb reasonable to proceed with IABP implantation in patients
where the catheter is placed. with impending shock/CS, provided it is implanted in the
• patient’s psychological state. very early phases of heart failure/CS, especially in Centres
that do not have more potent pMCS systems.
Nursing manoeuvre during counterpulsation. The nurse should:
Conflict of interest: none declared.
• pay attention to bedsores during daily patient hy-
giene, as the patient must constantly keep a supine
position without the possibility to move the lower Disclaimers
limb in which IABP is inserted.
This Position Paper was originally published in the Italian
• put IABP in ‘standby’ mode (if feasible) during any ma-
language in ‘Position paper ANMCO: Ruolo del contropulsa-
noeuvre in which the catheter could be moved. Once
tore aortico nel paziente con insufficienza cardiaca acuta
the manoeuvre is ceased, the device can be re-
avanzata’, official journal of Italian Federation of
activated pressing ‘START’ button on the console.
Cardiology (IFC), published by Il Pensiero Scientifico
• keep the patient in supine position with an inclination
Editore. Translated by a representative of the Italian
always < 30 to avoid kinking of the catheter.
Association of Hospital Cardiologists (ANMCO) and
reprinted by permission of IFC and Il Pensiero Scientifico
Editore.
Phase 4: from weaning phase to intra-aortic balloon
pump removal
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Circulation 2019;140:e559–60.

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European Heart Journal Supplements (2021) 23 (Supplement C), C204–C220

The Heart of the Matter

ANMCO POSITION PAPER: Role of intra-aortic balloon

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*Corresponding author. Tel 00390171642870, Email: roberta.rossini2@gmail.com

Published on behalf of the European Society of Cardiology. VC The Author(s) 2021.

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The external machine is composed of a console, a balloon

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Table 1 Deﬁnition of advanced heart failure

Stage A At risk A patient who is not currently experiencing signs or

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ABP-shock II ESC SCAI

INTERMACS stages for classifying patients with advanced heart failure

INTERMACS 1 • Cardiogenic shock Haemodynamic instability in spite of increasing doses of cate-

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rial pressure; PCI, percutaneous coronary intervention; V, volume.

was weaker (Class IIa, level of evidence B).22 Similarly,

myocardial revascularization.24 Afterwards, in 2012 ESC

STEMI guidelines IABP received a class IIb recommenda-

tion.25 After the publication of IABP-SHOCK II trial,16 rou-

cardial revascularization26 and in 2017 STEMI guide-

left in case of mechanical complications after AMI. The pro-

gressive downgrading of routine IABP use in CS may have

numerous consequences. First, a decrease in IABP use in

still use this device for CS to motivate their choice from a

legal perspective. Lastly, IABP could disappear as a stan-

dard therapy (control arm) in randomized clinical trials

aiming to evaluate other MCS devices in the setting of CS.

Intra-aortic balloon pump contexts of use beyond

control trial; STEMI, ST elevation myocardial infarction; TL, thrombolysis.

used in several contexts in addition to CS (Figure 5).

• Cardiogenic shock complicating myocardial infarc-

tion: in the thrombolytic era, IABP was mainly

or CS with overall favourable results in registries or

patients with CS complicating myocardial infarction

were implanted with this device. In the following

years, the era of primary percutaneous coronary in-

In 2012 the IABP SHOCK II trial, the larger trial ever

outcome in patients who received IABP with a deep

impact on following meta-analyses and international

puted advantages of PCI, a small percentage of

patients affected by myocardial infarction and treated

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adverse cardiovascular events at 30 and 90 days in

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the IABP group.39 In a recent prospective registry, Hawra-

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Study Design Patients (n) Control Primary Endpoint Result Follow-up

Seyfarth et al.64 Randomized 26 Impella Cardiac Index Signiﬁcant increase 30 min

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Practical recommendations on the use of no response to pharmacological therapy (espe-

bridge) or LVAD placement/transplantation (6) Ventricular arrhythmias refractory to pharmacolog-

Table 5 Factors contributing to deﬁne high-risk PCI

Coronary artery disease Clinical features Haemodynamic aspects

• Multivessel disease Comorbidities and cardiological conditions • Left ventricular dysfunction