Circulation: Heart Failure

ADVANCES IN HEART FAILURE, MECHANICAL CIRCULATORY SUPPORT AND

TRANSPLANT

Intra-Aortic Balloon Pumping in Acute

Decompensated Heart Failure With Hypoperfusion:
From Pathophysiology to Clinical Practice
Luca Baldetti , MD; Matteo Pagnesi, MD; Mario Gramegna , MD; Alessandro Belletti , MD; Alessandro Beneduce , MD;
Vittorio Pazzanese , MD; Francesco Calvo, MD; Stefania Sacchi, MD; Nicolas M. Van Mieghem , MD, PhD;
Corstiaan A. den Uil , MD; Marco Metra , MD; Alberto Maria Cappelletti , MD

ABSTRACT: Trials on intra-aortic balloon pump (IABP) use in cardiogenic shock related to acute myocardial infarction have
shown disappointing results. The role of IABP in cardiogenic shock treatment remains unclear, and new (potentially more
potent) mechanical circulatory supports with arguably larger device profile are emerging. A reappraisal of the physiological
premises of intra-aortic counterpulsation may underpin the rationale to maintain IABP as a valuable therapeutic option
for patients with acute decompensated heart failure and tissue hypoperfusion. Several pathophysiological features
differ between myocardial infarction- and acute decompensated heart failure–related hypoperfusion, encompassing
cardiogenic shock severity, filling status, systemic vascular resistances rise, and adaptation to chronic (if preexisting)
left ventricular dysfunction. IABP combines a more substantial effect on left ventricular afterload with a modest
increase in cardiac output and would therefore be most suitable in clinical scenarios characterized by a disproportionate
increase in afterload without profound hemodynamic compromise. The acute decompensated heart failure syndrome
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is characterized by exquisite afterload-sensitivity of cardiac output and may be an ideal setting for counterpulsation.
Several hemodynamic variables have been shown to predict response to IABP within this scenario, potentially guiding
appropriate patient selection. Finally, acute decompensated heart failure with hypoperfusion may frequently represent
an end stage in the heart failure history: IABP may provide sufficient hemodynamic support and prompt end-organ
function recovery in view of more definitive heart replacement therapies while preserving ambulation when used with
a transaxillary approach.

Key Words: cardiac output ◼ cardiac output, low ◼ heart failure ◼ intra-aortic balloon pumping ◼ patient selection ◼ shock, cardiogenic
◼ vascular resistance

I
ntra-aortic balloon pump (IABP) is a percutaneous infarction (MI) emerged as the focus of subsequent
device intended for mechanical circulatory support research.2 However, in the large randomized IABP-
(MCS). In 1953, the Kantrowitz brothers performed SHOCK II trial (Intraaortic Balloon Support for Myocar-
the first diastolic pressure augmentation experiment in dial Infarction with Cardiogenic Shock), including 600
an animal model with the aid of an elastic tube.1 Several patients with CS complicating MI, IABP on top of early
early IABP studies provided proof of diastolic flow aug- revascularization and medical therapy did not reduce the
mentation and end-diastolic pressure lowering effects, 30-day all-cause mortality primary end point.3
with simultaneous coronary perfusion improvement and A detailed overview of IABP studies in the MI setting
reduced left ventricular (LV) workload. The setting of is shown in Table 1.3–10 Despite enthusiasm based on the
cardiogenic shock (CS) complicating acute myocardial pathophysiological premises of IABP, the disappointing

Correspondence to: Luca Baldetti, MD, Cardiac Intensive Care Unit, San Raffaele Hospital, Via Olgettina, 60 – 20132 Milan, Italy. Email [email protected]
The Data Supplement is available at https://www.ahajournals.org/doi/suppl/10.1161/CIRCHEARTFAILURE.121.008527.
For Sources of Funding and Disclosures, see page 1273.
© 2021 American Heart Association, Inc.
Circulation: Heart Failure is available at www.ahajournals.org/journal/circheartfailure

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 Baldetti et al IABP in Acute Decompensated HF

impedance, systemic vascular resistances (SVRs) and,

Nonstandard Abbreviations and Acronyms therefore, both steady and pulsatile LV afterload2,23–28:
this translates in reduced myocardial work.25,29 Such
ADHF acute decompensated heart failure effects have been well characterized both with LV pres-
BTT bridge-to-transplant sure-volume analysis and with the wave-propagation
CS cardiogenic shock model. In addition, IABP may directly affect SVR through
HF heart failure vessel smooth muscle modulation.30 During diastole,
HRT heart replacement therapy IABP inflation raises central aortic mean diastolic pres-
HT heart transplant
sure and lowers central aortic end-diastolic pressure.31
The result of these combined effects is a normaliza-
IABP intra-aortic balloon pump
tion of the myocardial oxygen demand/supply ratio32–35
LV left ventricular
(Figures 1 and 2). IABP effects may be enhanced by
LVAD left ventricular assist device improved coronary blood flow, due to increased diastolic
MCS mechanical circulatory support perfusion gradient.
MI myocardial infarction Counterpulsation improves mechanical energet-
MR mitral regurgitation ics: the analysis of pressure-volume loops in preclini-
SCAI Society for Cardiovascular Angiography cal studies showed that IABP increases stroke volume
and Intervention (SV) and ejection fraction.25,36 Despite enhanced LV
SV stroke volume ejection, myocardial stroke work is reduced as a con-
SVR systemic vascular resistance sequence of decreased end-systolic pressure, translat-
ing also in reduced total mechanical work and reduced
intramyocardial stress25,26 (Figure 2). Coherently, the ratio
trials findings dramatically reduced its clinical utilization of stroke work to total mechanical work, a measure of
and the strength of recommendations for the MI setting cardiac energetic efficiency, is improved.25 These effects
(Table 2).11–18 Interestingly, while IABP use has declined translate in lower myocardial oxygen consumption.25,26
for MI-related CS, it concomitantly increased for other Summarizing these findings in a combined ventricular-
indications.11,19 This matches the increasing proportion to-arterial relation perspective, IABP enhances ventri-
of patients presenting with CS resulting from acute culo-arterial coupling37 (Figure 2). Such observations are
decompensated heart failure (ADHF), which currently based on theoretical and preclinical models, while data
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represents the most common CS etiology in contem- on humans is limited.

porary cardiac intensive care units.20 Within the ADHF
hospitalization, an increase in intensive care resources
utilization is observed, suggesting that the proportion of INTRA-AORTIC BALLOON PUMP-
critically ill patients with ADHF is rising.21 Recently, the ORIENTED PATHOPHYSIOLOGY OF HEART
Society for Cardiovascular Angiography and Interven-
tions (SCAI) released a consensus document to promote FAILURE
a homogeneous classification of patients with CS, which Several pathophysiological theoretical considerations
was subsequently endorsed by the European Society of frame the role of IABP in patients with ADHF and hypo-
Cardiology.22 In this system, CS stages range from A to perfusion. The chronic sympathetic nervous system β-
E, with increasing severity of hemodynamic compromise. adrenergic stimulation in heart failure (HF) induces LV
In patients with ADHF meeting SCAI B-D stages cri- maladaptive remodeling38 and myocardial β-adrenergic
teria, MCS may be considered: we will review available receptors desensitization and downregulation: therefore,
pathophysiological, preclinical, and clinical evidence to the inotropic reserve of the failing heart and its response
assess whether IABP may still find a therapeutic niche to catecholamines are reduced.39 Moreover, cAMP-
in the management of ADHF with hypoperfusion in cur- modulating β-adrenergic agonists failed to improve mor-
rent clinical practice. tality or were associated with excess harm in ADHF.40
Accordingly, IABP seems attractive in this context, as
it may decrease myocardial workload and oxygen con-
HEMODYNAMICS AND ENERGETICS sumption without exposing cardiomyocytes to the det-
rimental effect of inotropic agents. In addition, ADHF is
OF INTRA-AORTIC BALLOON PUMP
mechanistically characterized by a ventricular afterload
COUNTERPULSATION mismatch without preload reserve41,42: as a result, cardiac
IABP is an ECG-gated, volume-displacement pump. output (CO) is exquisitely sensitive to changes in after-
During systole, IABP deflation shifts a volume corre- load and may improve simply with its reduction, induced
sponding to the balloon size in the descending aorta, by IABP. In HF, a small reduction in LV afterload may
leading to reduced central aortic pressure, aortic translate in a clinically meaningful improvement in CO

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 Baldetti et al IABP in Acute Decompensated HF

Table 1. Summary of Studies Investigating the Use of IABP in the MI Setting

Primary outcome (IABP arm vs

Study Inclusion criteria Size Design comparator arm)* Other outcomes*
Ohman et al (TAC-
4
MI complicated by sustained 57 Fibrinolysis+IABP 6-mo all-cause mortality: 34% vs Trend toward greater benefit in
TICS trial) hypotension, CS or AHF, vs IABP only 43% (P=0.23) Killip classes 3–4 with IABP
eligible to fibrinolysis
Thiele et al5 MI-related CS with plan for 41 IABP vs tandem 2-h CPI change: 0.22 (IQR, 0.18– 30-d mortality 45% vs 43%
pPCI heart 0.30) to 0.28 (IQR, 0.24–0.36) W/ (P=0.86); lower severe bleeding
m2 vs 0.22 (IQR, 0.19–0.30) to 0.37 and limb ischemia with IABP
(IQR, 0.30–0.47) W/m2 (P=0.004)
Burkhoff et al6 CS (MI-related 70%) 42 IABP vs tandem 24-h composite end point of surviv- Greater hemodynamic improve-
heart al, CI≥2.2 L/min per m2, PCWP≤24 ment with tandem heart; 30-d
mm Hg and MAP≥70 mm Hg: 14% mortality: 36% vs 47% (P=NS)
vs 37%
Seyfarth et al7 (ISAR- MI-related CS 26 IABP vs Impella 2.5 30-min change in CI after MCS Overall 30-d mortality 46% in
SHOCK trial) initiation: 0.11±0.30 vs 0.49±0.46 both groups
L/min per m2 (P=0.02)
Prondzinsky et al8 MI-related CS treated with 45 IABP vs no-IABP Change in APACHE II score over 4 No change in CI or systemic in-
(IABP SHOCK trial) pPCI requiring inotropes/ d: −2.4 vs −2.8 points (P=NS) flammation biomarkers; BNP lev-
vasopressors els significantly lower with IABP
Patel et al9 (CRISP- Acute anterior STEMI with 337 Pre-PCI IABP vs Infarct size (% of total LV mass) Lower rate of death, shock, or
AMI trial) planned pPCI (excluding PCI only at CMR: 42.1% (95% CI, new or worsening heart failure
CS) 38.7%–45.6%) vs 37.5% (95% CI, in IABP group (5.0% vs 12.0%;
34.3%–40.8%) (P=0.06) P=0.03).
Thiele et al3 (IABP- MI-related CS with planned 600 IABP vs no-IABP 30-d all-cause mortality: 39.7% vs No difference in hemodynamic
SHOCK II trial) early revascularization 41.3% (P=0.69), RR, 0.96 (95% stabilization, lactate clearance,
CI, 0.79–1.17) renal function, duration of cat-
echolamine therapy
Ouweneel et al10 MI-related severe CS in the 48 IABP vs Impella CP 30-d all-cause mortality: 50% vs 6-mo mortality 50% in both
(IMPRESS in Severe setting of pPCI (all mechani- 46% (P=0.92), HR, 0.96 (95% CI, groups (P=0.92)
Shock trial) cally ventilated patients) 0.42–2.18)

AHF indicates acute heart failure; APACHE, Acute Physiology and Chronic Health Evaluation; BNP, brain natriuretic peptide; CI, cardiac index; CMR, cardiac magnetic resonance;
CPI, cardiac power index; CRISP-AMI, Counterpulsation to Reduce Infarct Size Pre-PCI Acute Myocardial Infarction; CS, cardiogenic shock; HR, hazard ratio; IABP, intra-aortic balloon
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pump; IMPRESS in Severe Shock, Impella Versus IABP Reduces Mortality in STEMI Patients Treated With Primary PCI in Severe and Deep Cardiogenic Shock; IQR, interquartile
range; ISAR-SHOCK, Efficacy Study of LV Assist Device to Treat Patients With Cardiogenic Shock; LV, left ventricle; MAP, mean arterial pressure; MCS, mechanical circulatory sup-
port; MI, myocardial infarction; PCWP, precapillary wedge pressure; pPCI, primary percutaneous coronary intervention; RR, relative risk; STEMI, ST-elevation myocardial infarction; and
TACTICS, Thrombolysis and Counterpulsation to Improve Survival in Myocardial Infarction Complicated by Hypotension and Suspected Cardiogenic Shock or Heart Failure.
*Outcomes are reported as IABP vs comparator, if not otherwise specified.

(Figure 3). Finally, a significant proportion of patients with compared with the MI group.47 In ADHF, reduction of SVR
ADHF-CS may present with ongoing chronic β-blocker ensues within the first 12 hours of counterpulsation48
therapy43 and IABP may offer a bridge toward stabili- and is paralleled by an increase in LV power indexes.35
zation, improving arterial pressure and perfusion while IABP effect on afterload has also been extensively used
these agents are washed-out. as a venting strategy in patients with CS receiving veno-
arterial extracorporeal membrane oxygenation support.
Indeed, retrograde flow of venoarterial extracorporeal
membrane oxygenation arterial cannula toward the fail-
INTRA-AORTIC BALLOON PUMP IN HEART
ing left ventricle increases its afterload, and IABP may
FAILURE NOT RELATED TO ACUTE MI lessen this effect favoring LV ejection, preventing LV dis-
During IABP support, CO increases modestly (0.5–1.0 L/ tention, pulmonary edema and death.49
min).2 Combining a profound effect on LV afterload but a In addition, the prevalence and severity of functional
modest increase in CO, IABP may be best suited for clini- mitral regurgitation (MR) increases with worsening
cal scenarios characterized by disproportionate increase degrees of LV systolic dysfunction and MR is associated
in afterload without profound hemodynamic compromise. with worse outcomes in ADHF.50 Functional MR is sen-
SVR increases with more pronounced LV dysfunction sitive to afterload reduction.51 In preclinical CS models,
and malperfusion, peaking in overt CS44; within the CS counterpulsation led to improvement in CO and reduc-
condition, patients with acute on chronic HF demon- tion in mitral regurgitant fraction.52 In general, moder-
strate higher SVR.45,46 This suggests a variable response ate or severe MR is a common finding (52%–68%)
to IABP support depending on CS etiology. Indeed, in a among patients treated with IABP for ADHF,48,53–55 and
cohort of patients with CS, CO increase and SVR drop its presence was associated with a trend for improved
with IABP were significantly higher in the ADHF as hemodynamics with IABP.54–56 Moderate or severe MR

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 Baldetti et al IABP in Acute Decompensated HF

Table 2. Summary of Guidelines and Recommendations on the Use of IABP/MCS in Cardiogenic Shock Setting

Class of Level of
Guidelines Recommendation recommendation evidence
European
2016 ESC guidelines for the diagnosis and IABP is not routinely recommended in cardiogenic shock III B
treatment of acute and chronic heart failure13
2017 ESC guidelines for the management of Routine IABP is not indicated (for the management of cardiogenic shock) III B
acute myocardial infarction in patients present-
IABP should be considered in patients with hemodynamic instability/car- IIa C
ing with ST-segment elevation14
diogenic shock due to mechanical complications
2020 ESC guidelines for the management of Routine use of IABP in patients with cardiogenic shock is not recommended III B
acute coronary syndromes in patients present-
IABP insertion should be considered in patients with haemodynamic insta- IIa C
ing without persistent ST-segment elevation15
bility/cardiogenic shock due to mechanical complications
American
2013 ACCF/AHA guideline for the manage- MCS is beneficial in carefully selected patients with stage D HF in whom IIa B
ment of heart failure16 definitive management (eg, cardiac transplantation) is anticipated or planned
Nondurable MCS is reasonable as a bridge to recovery or bridge to deci- IIa B
sion for carefully selected patients with HF and acute profound disease
2013 ACCF/AHA guideline for the manage- IABP can be useful for patients with cardiogenic shock after STEMI who IIa B
ment of ST-elevation myocardial infarction17 do not quickly stabilize with pharmacological therapy
To provide temporary circulatory support in patients with mechanical compli- … …
cations (papillary muscle rupture with severe MR, ventricular septal defect)
2014 AHA/ACC guideline for the manage- IABP counterpulsation may be used in patients with NSTE-ACS to treat se- … …
ment of patients with non–ST-elevation acute vere persistent or recurrent ischemia, especially in patients awaiting invasive
coronary syndromes18 angiography and revascularization, despite intensive medical therapy

ACC indicates American College of Cardiology; ACCF, American College of Cardiology Foundation; AHA, American Heart Association; ESC, European Society of
Cardiology; HF, heart failure; IABP, intra-aortic balloon pump; MCS, mechanical circulatory support; MR, mitral regurgitation; NSTE-ACS, non-ST elevation acute coronary
syndrome; and STEMI, ST-elevation myocardial infarction.

was predictor of favorable hemodynamic response to Modulation of splanchnic blood flow with IABP may
IABP in the specific setting of acute on chronic HF pre- exert favorable effects. The increase in renal blood flow
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senting with CS.56 with IABP57 may encourage its use in patients with

Figure 1. Pressure tracings from intra-aortic balloon pump (IABP) console (red tracing).
Aortic pressure readings from a patient with effective counterpulsation. Setting IABP counterpulsation ratio to 1:2, it is possible to appreciate
the systolic unloading of the assisted beats following augmented (nonassisted) beats as a reduction in peak systolic pressure (arrows) and the
end-diastolic pressure lowering of the augmented (nonassisted) beats (arrowheads). The reduction of the area under the systolic curve of the
aortic pressure waveform in assisted beats (systolic pressure-time index, proportional to myocardial oxygen demand), and the increase in the
area under the diastolic curve of the aortic pressure waveform in augmented beats (diastolic pressure-time index, proportional to myocardial
oxygen supply), improve oxygen supply-demand match.

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 Baldetti et al IABP in Acute Decompensated HF

Figure 2. Idealized pressure volume loops (PVL).

A, An ideal PVL without intra-aortic balloon pump (IABP) is depicted in yellow; the PVL resulting from IABP activation is depicted in blue. The
Ea (slope of red line connecting end-diastolic volume [EDV] to end-systolic point [ESPo]) represents effective arterial elastance, an adequate
measure of left ventricular (LV) afterload in cases of impaired LV function. Switching the IABP on, the effective arterial elastance is reduced
(Ea-IABP), and the SV (the difference between EDV and – end-systolic volume [ESV]) is increased. The end-systolic elastance (Ees: the slope
of the end-systolic pressure-volume relationship [ESPVR] line), a measure of LV inotropy, is not affected by IABP. As the Ea is lowered by
IABP, the ratio Ea/Ees (ventriculoarterial coupling) is also lowered to 0.5 to 1.0, translating in improved system coupling. B, PVL without IABP
is depicted in yellow. PVL after IABP activation is depicted in light blue. Note the lowering of ESPo (ESPo1→ESPo2) with IABP. The area
comprised between the PVL, the ESPVR, and the end-diastolic pressure-volume relationship (EDPVR) is directly proportional to the myocardial
energetic expenditure and O2 consumption. As the yellow area is larger than the blue area, the total PVL area is larger in the cycle without IABP
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support, as is the myocardial oxygen consumption. EDP indicates end-diastolic pressure; ESP, end-systolic pressure; and LV, left ventricle.

hypoperfused ADHF presenting with moderate/severe m2) discriminated patients who would stabilize during
kidney dysfunction (up to 56% of patients with ADHF),58 IABP support.53 In a specular analysis, a lower LV car-
especially when reduced renal blood flow is perceived as diac power output index was predictor of deterioration
the leading mechanism of type-1 cardiorenal syndrome. during support.48
Indeed, a greater negative fluid balance was reported Based on the principle of volume displacement,
among patients with diuretic-resistant ADHF random- higher degree of pulmonary congestion (higher values
ized to IABP as compared with inotropes.59 of mean pulmonary arterial pressure) may be expected
to “provide” adequate preload to IABP.55,56 In ADHF, this
suggests the presence of postcapillary pulmonary hyper-
“RESPONDERS” TO INTRA- tension; in several reports, pulmonary capillary wedge
AORTIC BALLOON PUMP IN ACUTE pressure was indeed elevated at 28 to 29 mm Hg.48,53,55,59
Higher baseline SVR has been found in IABP
DECOMPENSATED HEART FAILURE WITH
responders.35,56 Notably, a lower SVR may also reflect a
HYPOPERFUSION coexisting inflammatory state that may respond less to
The rationale to initiate IABP support requires identifi- IABP therapy,60 and mixed (cardiogenic and vasodilatory)
cation of the “best responder”, based on the anticipated shock admissions are relatively common in modern car-
hemodynamic effects. Several hemodynamic parameters diac intensive care units.61
have been linked to positive response to counterpulsa- As IABP primarily affects the left ventricle, patients
tion in patients with hypoperfused ADHF. stabilizing during treatment showed better baseline
IABP efficacy depends on effective intra-aortic parameters of RV function, including a lower baseline
volume displacement, hence cardiac hydraulic power central venous pressure, a pulmonary artery pulsatil-
should be sufficient to generate an appropriate ejec- ity index ≥2.0, and higher values of right ventricular
tion. In patients with HF, a LV cardiac power output cardiac power output index.35,53,55 Although patients
index ≥0.33 W/m2 (especially in combination with a with biventricular failure more often require support
right ventricular cardiac power output index ≥0.13 W/ escalation when treated with IABP, RV involvement

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 Baldetti et al IABP in Acute Decompensated HF

Figure 3. Different response to intra-aortic balloon pump (IABP) in the failing left ventricle (LV) and in the LV with physiological
systolic and diastolic properties.
An ideal pressure volume loops (PVL) without IABP is depicted in yellow; the PVL resulting from IABP activation is depicted in blue. In the
failing LV, the slope of end-systolic pressure-volume relationship (ESPVR; a measure of inotropic state) is flattish and the LV works at higher
end-diastolic volume (EDV) and end-diastolic pressure (EDP), while the healthy LV features a steep ESPVR slope and works at smaller EDV
and EDP. Switching on the IABP decreases the afterload, as shown by the slope of the Ea (Ea-IABP): for identical reduction in the afterload, the
increase in SV (SV IABP on vs SV IABP off) is more pronounced in the failing LV (A) as compared with the physiological LV (B). EDV indicates
end-diastolic volume; EDPVR, end-diastolic pressure-volume relationship; IABP, intra-aortic balloon pump; LV, left ventricle; and SV, stroke
volume.
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should not be considered an absolute contraindication

to counterpulsation: patients with biventricular failure
CLINICAL OUTCOMES WITH INTRA-
treated with IABP experience similar in-hospital mor- AORTIC BALLOON PUMP IN ACUTE
tality than those with isolated LV failure,62 and pro- DECOMPENSATED HEART FAILURE WITH
longed IABP may induce reverse remodeling of the HYPOPERFUSION
failing right ventricle.63
Finally, tachycardia may hamper effective counterpul- IABP is currently the most commonly adopted device
sation: a baseline heart rate <92 beats per minute was a in ADHF-related CS.65 Several observational studies on
predictor of stabilization following IABP insertion.54 patients with ADHF and hypoperfusion receiving IABP are
Among clinical variables, ischemic cardiomyopathy available (Table 3).35,47,48,53–55,59,60,63,66–73 The recently published
has consistently been associated with worse outcome Altshock phase-II trial (REGISTRATION: URL: https://www.
in patients with CS receiving IABP48,55: presence of clinicaltrials.gov; Unique identifier: NCT02591771) met the
ischemic cardiomyopathy may correlate with a higher prespecified primary end point of 60-day mortality ≤30%
baseline clinical risk due to comorbidities or iden- (observed all-cause mortality 12.5%).67 Globally, retrospec-
tify patients with more advanced LV dysfunction and tive studies on unselected patients with ADHF undergoing
poorer contractile reserve secondary to extensive intra-aortic counterpulsation demonstrate a 30-day mortality
myocardial scarring. of 23.6% to 40.7%.48,60,66,74 In these cohorts, implementation
Based on the invasive nature of most hemodynamic of definitive heart replacement therapies (HRTs) is reported
stabilization predictors, the use of a pulmonary artery in 5.2% to 51.4%. Among studies selecting patients receiv-
catheter should be considered in ADHF IABP recipi- ing IABP with a bridging purpose, the reported mortality was
ents, and this has also been endorsed by current pro- lower and varied between 4.6% and 16.7%.53,75 In these
tocols for CS management.64 In summary, the expected cohorts, a higher rate of HRT was observed (65.9%–91.7%):
responder to IABP in hypoperfused ADHF not related conceivably, implementation of definitive HRT improves sur-
to MI would be a patient with significantly elevated SVR, vival in this critical population.
isolated LV or biventricular dysfunction, exhibiting pul- The proportion of patients who would stabilize with
monary circulation congestion, and presenting without IABP is difficult to estimate, as hemodynamic and clinical
excess tachycardia (Figure 4). definitions vary between studies. Among studies clearly

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 Baldetti et al IABP in Acute Decompensated HF

Figure 4. Hemodynamic variables to identify the best responder patient phenotype for intra-aortic balloon pump (IABP) in
hypoperfused acute decompensated heart failure (ADHF).
Created with www.BioRender.com. CI indicates cardiac index; CVP, central venous pressure; HR, heart rate; LCPOi, left ventricle cardiac
power output index; mPAP, mean pulmonary artery pressure; PAPi, pulmonary artery pulsatility index; PCWP, pulmonary capillary wedge
pressure; RCPOi, right ventricle cardiac power output index; RV, right ventricle; and SVR, systemic vascular resistances.

reporting this data, the end point is reached in 35.2% to A detailed overview of observational, randomized
74.2%,53–55,60 while MCS escalation during IABP treat- completed and ongoing studies is available in Table 3.
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ment is estimated at 4.1% to 7.6%.47,48,54,60,67 IABP-related

complications are low: a detailed summary is available in
Appendix in the Data Supplement. EXPLAINING THE DIFFERENTIAL EFFECT
The only randomized study available to date is an open- The reasons why IABP may be particularly suited for
label trial that randomized 32 diuretic-resistant patients ADHF-related versus MI-related CS/hypoperfusion
with ADHF not related to MI to either primary IABP (50 remain elusive. IABP works best in patients with high
mL balloons) or inotropes (enoximone or dobutamine).59 systemic filling pressure, pulmonary congestion, and with
Primary end point was the change in mixed venous oxy- preserved pulsatile activity to guarantee an adequate SV
gen saturation (SvO2) after 3 hours of support: in the IABP to fill the displaced volume in the descending aorta: these
group the improvement in SvO2 was greater, and most features are all usually present in patients with ADHF,
patients achieved SvO2>60%. IABP treatment was also especially in case of preexisting HF.77–79 In addition, LV
superior in several 48-hour secondary end points, includ- dilatation in case of chronic HF may ensure a greater SV
ing higher increase in left ventricular cardiac power output, for any given ejection fraction. To achieve adequate dia-
higher decrease in NT-proBNP levels, greater reduction stolic augmentation, the balloon volume should approx-
in dyspnea, and greater negative fluid balance. Notably, imate that of the descending aorta.24 Aortic volume is
30-day all-cause mortality was numerically lower in the related to mean arterial pressure80: acute MI-related CS,
IABP group (23% versus 44%). Overall, this trial sug- featuring lower mean arterial pressure as compared with
gested the feasibility of early IABP support in patients ADHF-related CS characterized by higher filling pres-
with ADHF that would meet SCAI B-C stages criteria. sures, may hence prevent adequate counterpulsation.
Retrospective data on unselected patients with CS with a Moreover, sympathetic overactivation in cases of acute
40% prevalence of nonacute coronary syndromes etiology onset of CS/hypoperfusion (worsened by ischemia and
demonstrated lower in-hospital mortality with IABP use chest pain), may further hamper IABP function due to
across each SCAI stage, except for SCAI E stage.76 There- reflex tachycardia.77 The expected improvement in CO
fore, upfront IABP might be considered in ADHF SCAI with IABP is modest and may be insufficient to reverse
B-D stages if the device is deemed appropriate based on the profound hypoperfusion caused by acute compro-
patient hemodynamic status and metabolic demand. How- mise of LV function,25 but may be enough to stabilize
ever, in the absence of robust randomized data, these con- patients with HF adapted to chronically reduced CO with
clusions remain preliminary and hypothesis-generating. higher oxygen extraction rate from circulating blood.78
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 Baldetti et al IABP in Acute Decompensated HF

Table 3. Summary of Studies Investigating the Use of IABP in Hypoperfused ADHF

IABP size, Hemodynamic,

IABP configuration, and echo, or lab HRT-free
Study Inclusion criteria patients support duration improvements survival HRT Other outcomes
IABP in hypoperfused ADHF
 Umakanthan End-stage HF and failure on/ 18 Size: n/a CI, CVP, mPAP, Recovery HT 72% Death 28% (6%
et al73 intolerant to inotropes sPAP, 0% despite LVAD)
1-mo survival 89%
Retrospective Axillary duration: 6-mo survival 72%
27±18 d
Mizuno et al66 ADHF who met modified Framing- 123 vs Size: n/a … Recovery … Death 29%
ham HF criteria, considered suit- 4678 71%
Prospective Femoral duration:
able (IABP) vs control (no IABP)
n/a
Ntalianis et al63 End-stage HF, NYHA IV, INTER- 15 Size: n/a CI, mPAP, PCWP, Recovery LVAD 40% Death 40%
MACS 1-2 despite OMT, severe RAP, RVSWI, cre- 20%
Prospective Femoral duration:
LV and RV systolic dysfunction atinine, bilirubin,
73±50 d
with contraindication to HRT LVEF, RVEDD
den Uil et al60 Inotrope-dependent HF with 27 Size: 50 mL MAP, RAP, Recovery LVAD 19% Death 26%
signs of hypoperfusion and tis- SvcO2, fluid bal- 26%
HT 22% 30-d survival 67%
sue hypoxia, INTERMACS 1-2 ance, sodium,
Retrospective Femoral duration: serum lactate ECMO 7% 1-year survival 63%
median 4 d
Annamalai et al35 Stage D HF, NYHA III-IV, IN- 10 50 mL CPO, DPTI, … LVAD 100% …
TERMACS 2-3, inotrope-depen- LVESP, LVSW,
Prospective Femoral duration:
dent with persistently low CO PAP, PVR, myo-
<48 h
within 48 h of LVAD surgery cardial oxygen
supply/demand,
Hsu et al48 CS (89% HFrEF) defined as 74 Size: n/a CI, DBP, HR, Recovery LVAD 45% Death 24%
SBP<90 mm Hg for >30 min LVCPI, PAP, 20%
HT 8%
with poor end-organ perfusion PCWP, RAP,
Retrospective or need for inotropes Femoral duration: SBP, SVR MCS 4%
n/a
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Morici et al67 Severe LV dysfunction, SBP<90 17 Size: n/a - Recovery LVAD 53% Death 18%
mm Hg or MAP<60 mm Hg 12%
HT 12%
after fluid challenge or RAP>12
Prospective mm Hg or PCWP>14 mm Hg Femoral duration: ECMO 6%
with signs of end-organ hypo- median 7 d
perfusion, OMT failure (88%
after failure of inotropes)
Fried et al55 ADHF with CS (CI<2.2 L/min 132 Size: n/a CI, CO, mPAP Recovery LVAD 52% Death 18%
per m2 and SBP<90 mm Hg or 16%
HT 6%
need for vasoactive medications
Retrospective to achieve SBP>90 mm Hg Femoral (1 axil- MCS 8% 30-d survival 84%
(87% on ≥1 inotrope and 28% lary) duration:
on ≥1 vasopressor) median 96 h
Imamura et al54 Advanced worsening HF (69% 91 Size: n/a CI, CVP, PCWP, Recovery LVAD or HT Death 9%
on inotropes) creatinine, serum 12% 69%
lactate
Subclavian dura- MCS 4%
tion: 25±20 d
Retrospective
Malick et al47 ADHF with CS (CI<2.2 L/min 132 Size: n/a CI, CO, CPI, Recovery HRT 62% Death 22%
per m2 and SBP <90 mm Hg or CPO, CVP, SVR, 16%
Retrospective Femoral duration: MCS 8%
need for vasoactive medications mPAP
median 3 d
to achieve to achieve SBP>90
mm Hg)
den Uil et al59 Patients with diuretic-resistant 32 Size: 50 mL Greater 3-h SvO2 … HRT: IABP 30-d mortality, IABP
ADHF patients without ongoing increase in the vs inotropes vs inotropes: 23 vs
ischemia randomized to IABP IABP group (pri- 31% vs 0% 44% (P=0.25)
vs inotropes (enoximone/dobu- mary end point) (P<0.05)
Randomized Femoral duration: Greater negative
tamine)
median 4 d fluid balance, dys-
pnea reduction, NT-
proBNP reduction
and CPO increase
in the IABP group

(Continued )

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 Baldetti et al IABP in Acute Decompensated HF

Table 3. Continued

IABP size, Hemodynamic,

IABP configuration, and echo, or lab HRT-free
Study Inclusion criteria patients support duration improvements survival HRT Other outcomes
IABP in hypoperfused ADHF as bridge to device/transplantation
Norkiene et al70 Acute decompensated DCM 11 Size: 40 mL CVP, MAP, LVEF Recovery LVAD 27% Death 27% (2 after
27% IABP interruption)
Retrospective NYHA IV refractory to OMT Femoral duration:
182±82 h
MAP<65 mm Hg, CI<2 L/min HT 18%
per m2, PCWP>20 mm Hg
Gjesdal et al71 End-stage HF refractory to 40 vs Size: 40–50 mL AST, ALT, biliru- Recovery ECMO 10% Death 5% (2.5%
OMT (IABP) vs stable on OMT 135 bin, creatinine, 0% on IABP)
Retrospective Femoral duration: LVAD 5%
(control) urea
21±16 d from
IABP to HT
25±21 d from
IABP to MCS
Russo et al72 Severe decompensated HF 17 Size: n/a … Recovery HT 82% Death 0%
awaiting HT 0%
Retrospective Subclavian dura- On HT LVAD 6%
tion: 17±13 d list 6%
Sintek et al53 HFrEF developing CS refractory 54 Size: mean 42 mL CI, CPI, PCWP, Stabi- MCS 11% Death 17%
to OMT and INTERMACS 1-2 sPAP (only in re- lized*
Retrospective Femoral duration:
who received LVAD after IABP sponders), urinary 57%
median 2 d (de-
bridge output
compensated) me-
dian 3 d (stabilized)
Tanaka et al68 Advanced DCHF clinical diag- 88 Size: 30/40/50 mL CI, CVP, mPAP, LVAD, HT Death 7%
nosis confirmed by RHC, 56% PCWP, creatinine or recovery
Retrospective Subclavian
on inotropes, mean CI 1.9±0.6 93% (3.4%
L/min per m2 as bridge to HRT Duration: 21±22 d MCS)
Bhimaraj et al 69
Advanced HF dependent on 195 Size: n/a Bilirubin, BUN, Recovery HT 62% Death 8%
hemodynamic support until HRT WBC 0%
Retrospective Axillary LVAD 7% IABP removal due
(71% on inotropes) mean SVO2
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to lack of HRT eligi-

54%
bility 3%
Duration: median MCS 9% IABP removal due to
19 d complications 11%
Currently enrolling studies investigating IABP for ADHF and advanced HF
Study Inclusion criteria Size Design Primary outcome
Altshock-2 ADHF complicated by CS 200 IABP vs standard of care (vasoactive 60-d survival or successful bridge to HRT (HT
(NCT04369573) agents) or LVAD)
Feasibility study Advanced HF patients (NYHA 100 Single arm (iVAS system) 30-d survival to transplant or stroke-free survival
of the iVAS classes III-IV)
(NCT02645539)

ADHF, acute decompensated heart failure; ALT, alanine aminotransferase; AST, aspartate aminotransferase; BUN, blood urea nitrogen; CI, cardiac index; CO, cardiac
output; CPI, cardiac power index; CPO, cardiac power output; CS, cardiogenic shock; CVP, central venous pressure; DBP, diastolic blood pressure; DCHF, decompensated
congestive heart failure; DCM, dilated cardiomyopathy; DPTI, diastolic pressure time index; ECMO, extracorporeal membrane oxygenation; HF, heart failure; HFrEF, heart
failure with reduced ejection fraction; HR, heart rate; HRT, heart replacement therapies; HT, heart transplantation; IABP, intra-aortic balloon pump; INTERMACS, Inter-
agency Registry for Mechanically Assisted Circulatory Support; LV, left ventricle; LVAD, left ventricular assist device; LVCPI, left ventricular cardiac power index; LVESP,
left ventricular end systolic pressure; LVSW, left ventricular stroke work; MAP, mean arterial pressure; MCS, mechanical circulatory support; mPAP, mean pulmonary artery
pressure; NYHA, New York Heart Association; NT-proBNP, N-terminal pro-B-type natriuretic peptide; OMT, optimal medical therapy; PAP, pulmonary artery pressure;
PCWP, precapillary wedge pressure; PVR, pulmonary vascular resistance; RAP, right atrial pressure; RHC, right heart catheterization; RV, right ventricle; RVEDD, right
ventricular end diastolic diameter; RVSWI, right ventricular stroke work index; SBP, systolic blood pressure; sPAP, systolic pulmonary artery pressure; SvcO2, central
venous oxygen saturation; SvO2, mixed venous oxygen saturation; SVR, systemic vascular resistance; and WBC, white blood cell.
*Stabilization refers to all the following 5 criteria: (1) no need for any other temporary MCS; (2) no need for an increase in dose or number of vasopressor or inotrope
support; (3) no need for renal replacement therapy or mechanical ventilation; (4) no refractory ventricular arrhythmias; or (5) no worsening metabolic acidosis.

support.47,48,54 Transitioning such patients from a stable

STABILIZATION AFTER INTRA-AORTIC condition during MCS to an operating setting for left
BALLOON PUMP SUPPORT ventricular assist device (LVAD)/heart transplant (HT)
IABP may provide hemodynamic and clinical stabilization requires recovery of end-organ dysfunction for the eli-
but raises the need for further treatment options after gibility to HRT.81 In patients with ongoing MCS, IABP
MCS weaning or pursuit of definitive HRT. support has been shown to revert both kidney and liver
A significant proportion of IABP recipients injury.54,68,82 Improved hemodynamics, shorter intensive
(51%–69%) remains dependent on the circulatory care stay, reduced postoperative rates of kidney and

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 Baldetti et al IABP in Acute Decompensated HF

liver dysfunction, and reduced costs after LVAD implan- Hence, hemodynamic improvement is not a prerequisite
tation have been demonstrated in patients receiving for clinical stabilization if a definitive HRT can be pro-
preoperative IABP.69,83,84 vided in reasonable time and hemodynamic improvement
MCS-dependent HT candidates may remain on the with support devices may not affect overall prognosis if
waiting list for a prolonged period before undergoing nonhemodynamic factors preclude HRT eligibility.
surgery, because of the limited heart donor availability.
Within the IABP options, axillary implantation may be
exquisitely suited for the bridge-to-transplant (BTT) set- PRACTICAL CONSIDERATIONS
ting,85 as it allows for prolonged support while preserving Multiple IABP balloon sizes are currently available. In
mobilization and preventing physical deconditioning: in a 2015, a higher hemodynamic efficacy was reported
cohort of 133 patients awaiting HT, axillary IABP allowed with the use of 50 mL balloons.94 As compared with
mobilization in 98.5% at a postimplantation median of 2 40 mL balloons, 50 mL balloons led to greater systolic
days, with a median support duration of 3 weeks.75 Active unloading, higher diastolic pressure augmentation, and
rehabilitation during counterpulsation improves physical improved hemodynamics.94–96 Interestingly, larger bal-
training measures73,75 and may allow for inotropes de- loons may be particularly beneficial in patients with
escalation in up to 55% of patients.68 Currently, however, chronically dilated ventricles, potentially ensuring higher
this use is not endorsed by manufacturers and should be SV for any given ejection fraction.
considered off-label. Despite a greater use in the axil- Low blood pressure (BP) in patients with advanced
lary configuration, little has changed in IABP technol- HF may either be a consequence of (1) reduced SV
ogy: indeed, IABP devices are designed and intended (affecting primarily systolic BP), (2) a consequence of
as transfemoral devices and specific complications may relatively depleted intravascular volume, (3) peripheral
arise from a transaxillary implant including stroke (for the vasodilation secondary to HF neurohumoral modulating
proximity of carotid artery), axillary nerve injury, and need agents, or (4) vasoplegia due to autonomic dysfunc-
of balloon exchange due to kinking, malposition or rup- tion or concomitant inflammation (all affecting primarily
ture (Appendix in the Data Supplement). mean and diastolic BP).97 Differentiation of hypoten-
A broadened IABP use for the BTT indication comes sion etiology is paramount because IABP is ineffective
along the 2018 UNOS modification of the allocation and even detrimental in the context of pure vasoplegia.
system for adults on a waiting list for orthotopic HT: the Pulmonary artery catheter-guidance may help reveal
listing prioritization based on the treatment received may the hemodynamic status and select the proper sup-
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be prone to provider bias, with a more liberal adoption portive measures.

of IABP to reduce the time on the waiting list. Indeed, The optimal timing of IABP implantation is unclear.
IABP use configures a high priority “status 2”, and recent Retrospective data suggests survival benefit with early
data suggest reduced time on the waiting list and com- (≤1 hour from CS onset) IABP insertion,74 and the
parable posttransplant outcomes with larger IABP use.86 importance of early circulatory support in CS has also
Other temporary MCS or durable LVAD may also offer been demonstrated for percutaneous ventricular assist
valid bridging to HT. Older studies suggested similar device,98 suggesting that a golden hour timespan might
1-year survival87,88 but improved waiting list survival with allow for prompt reversal of hypoperfusion with prog-
LVAD as compared with inotropes plus IABP.88 IABP nostic implications. However, ample divergence exists in
offers the advantage of avoiding sternotomy and reduces published prospective studies, with a minimum of 4-hour
the risk of acquired von Willebrand disease but seems observation in the Altshock trial and a median of 19 (12–
to increase hemorrhagic events.86 The use of IABP 29) hours from hospital admission to randomization in
as BTT has been associated with fewer total costs, as the trial by den Uil et al.59,67 Based on the importance of
compared with LVAD or percutaneous ventricular assist an early correction of hemodynamic derangement in CS,
devices.89,90 Both the cost of the device and the possible an “upfront” MCS approach rapidly matching patient’s
complications related to the higher invasiveness of sur- metabolic demands, with either IABP or a more powerful
gical LVAD and percutaneous ventricular assist devices pump, may be superior to an escalating approach. More
may increase the economic burden of these approaches. data are needed to ascertain whether a primarily invasive
Nevertheless, percutaneous ventricular assist device approach (IABP insertion) versus an observational period
BTT use has also increased after the 2018 UNOS revi- to ensure appropriate inotropic/vasopressor support pro-
sion91 and may offer a more tailored support (uni- or bi- vides the optimal balance between rapid hypoperfusion
ventricular) based on the hemodynamic conditions: to reversal and minimization of procedural risks.
date, no direct comparison between these devices and Finally, when compared with other MCS, IABP fea-
IABP has been performed. Finally, long-term inotropic tures an easier insertion, allowing for rapid bed-side
treatment may provide a less invasive (and costly) BTT transfemoral implantation, and lower costs, which may
alternative,92,93 as most patients successfully undergo HT translate into a wider availability across cardiac intensive
even without appreciable hemodynamic improvement.93 care units, also in developing and low-income countries.

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 Baldetti et al IABP in Acute Decompensated HF

FUTURE PERSPECTIVES ADHF is moving toward more critically ill patients, often
presenting with impending or overt hypoperfusion. Sev-
The hypothesis that IABP support may induce a sus-
eral pathophysiological premises along with the pro-
tained reverse remodeling is matter of debate. In a
nounced effect of IABP on LV afterload make it an
small report on patients with advanced HF with biven-
attractive option for patients with ADHF presenting with
tricular failure, a mean of 73±50 days of counterpul-
hypoperfusion outside the context of acute MI. A number
sation led to reduced RV diameters and improved RV
of clinical studies has provided a summary of the hemo-
function63: however, such patients would be bound
dynamic features of patients who would best respond to
to the cardiac intensive care unit. Recently, the
this treatment. Prolonged counterpulsation in the axillary
NuPulseCV iVAS intravascular ventricular assist sys-
configuration may also offer a valid bridge to recovery,
tem has become available. This device features a 50
decision, LVAD, or HT allowing for end-organ dysfunction
mL intra-aortic balloon that is surgically implanted
recovery, ambulation, and active rehabilitation. Powered
through a subclavian graft and is connected to an
clinical trials should further evaluate the role of IABP in
external, portable drive unit trough a skin interface
the context of ADHF with hypoperfusion.
device. This treatment, which has been employed in
patients with advanced HF eligible to HT with accept-
able short-term outcomes, combines the advantages ARTICLE INFORMATION
of aortic counterpulsation with the possibility of out- Affiliations
of-hospital ambulatory support.99 The ongoing fea- Cardiac Intensive Care Unit, Department of Anesthesia and Intensive Care (A.
sibility study (REGISTRATION: URL: https://www. Belletti) and Unit of Cardiovascular Interventions (A. Beneduce), IRCCS San Raf-
clinicaltrials.gov; Unique identifier: NCT02645539) faele Scientific Institute, Milan, Italy (L.B., M.G., V.P., F.C., S.S., A.M.C.). Department
of Cardiology, ASST Spedali Civili and Department of Medical and Surgical Spe-
will enrich our knowledge on safety and efficacy of cialties, Radiological Sciences and Public Health, University of Brescia, Italy (M.P.,
this device and possibly also on the long-term effects M.M.). Department of Cardiology and Intensive Care Medicine, Thoraxcenter,
of counterpulsation. Erasmus MC, University Medical Center, Rotterdam, the Netherlands (N.M.V.M.,
C.A.d.U.). Department of Intensive Care Medicine, Maasstad Hospital, Rotterdam,
Finally, lessons from randomized studies on IABP in the Netherlands (C.A.d.U.).
MI-related CS prompt a careful reconsideration of what
to expect from randomized data on IABP in the CS Acknowledgments
We take responsibility for all aspects of the reliability and freedom from bias of
context. The hyperacute setting of MI-related CS intro- the data presented and their discussed interpretation.
duced significant heterogeneity in terms of baseline
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patients’ characteristics, coronary anatomy, reperfusion Sources of Funding

None.
approaches and supportive measures, which may partly
explain subpar results of pivotal trials on MI-related CS. Disclosures
In the wake of a reappraisal of IABP for ADHF-related None.
CS, design and conduct of dedicated randomized studies Supplemental Materials
should consider: (1) inclusion criteria based on SCAI CS References 100-111
classification (with SCAI B-C stages most suitable for
IABP support) and on pulmonary artery catheter guid-
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