JACC: CARDIOVASCULAR INTERVENTIONS VOL. 9, NO.

9, 2016

ª 2016 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION ISSN 1936-8798/$36.00

PUBLISHED BY ELSEVIER http://dx.doi.org/10.1016/j.jcin.2016.02.046

STATEMENT FROM THE INTERVENTIONAL COUNCIL OF THE ACC

A Practical Approach to Mechanical

Circulatory Support in Patients Undergoing
Percutaneous Coronary Intervention
An Interventional Perspective

Tamara M. Atkinson, MD,a E. Magnus Ohman, MD,b William W. O’Neill, MD,c Tanveer Rab, MD,d
Joaquin E. Cigarroa, MD,a on behalf of the Interventional Scientific Council of the American College of Cardiology

ABSTRACT

Percutaneous mechanical circulatory support has been used to stabilize patients in cardiogenic shock and provide
hemodynamic support during high-risk percutaneous coronary interventions for several decades. The goal of this paper is to
provide a practical approach to percutaneous mechanical circulatory support in patients undergoing percutaneous coronary
intervention with cardiogenic shock and/or high risk features to aid in decision making for interventional cardiologists.
(J Am Coll Cardiol Intv 2016;9:871–83) © 2016 by the American College of Cardiology Foundation.

P ercutaneous mechanical circulatory support

(MCS) has evolved dramatically since the
first intra-aortic balloon pump (IABP) was
used in humans in the 1960s (1,2). Although IABP
has been the mainstay of MCS devices, recent
studies have demonstrated lack of efficacy (3–5).
In the setting of cardiogenic shock and high-risk
percutaneous coronary intervention (HR-PCI), the
introduction of newer devices coupled with data
from clinical trials is challenging the role of the
IABP (6–8). Mechanical circulatory support, such as
Impella (Abiomed Inc., Danvers, Massachusetts),
TandemHeart (CardiacAssist, Inc., Pittsburgh, Penn-
sylvania), and extracorporeal membrane oxygena-
tion (ECMO), all possess an ability to provide
greater hemodynamic support and may improve
clinical outcomes.
MCS is used primarily in 3 populations including
HR-PCI, cardiogenic shock, and cardiac arrest. As
defined by the 2015 Society for Cardiovascular Angi-
ography and Interventions/American College of
Cardiology/Heart Failure Society of America/Society
of Thoracic Surgeons Clinical Expert Consensus on
the use of percutaneous MCS in cardiovascular care,
the purpose of MCS is to reduce left ventricular stroke
work and myocardial oxygen demand while main-
taining systemic and coronary perfusion in the setting
of cardiogenic shock or to provide hemodynamic
support during complex cardiac procedures including
HR-PCI and certain high-risk ventricular tachycardia
electrophysiology ablation procedures (9). With
multiple treatment modalities available, the chal-
lenge for the practicing interventional cardiologist is
to understand which MCS offers the best use in each

From the aKnight Cardiovascular Institute, Oregon Health and Science University, Portland, Oregon; bDuke Clinical Research
Institute, Duke University Medical Center, Durham, North Carolina; cDivision of Cardiology, Henry Ford Hospital, Detroit,
Michigan; and the dDivision of Cardiology, Emory University School of Medicine, Atlanta, Georgia. This manuscript does not
reflect the opinion of the American College of Cardiology or the JACC: Cardiovascular Interventions. Dr. Ohman has served as a
consultant for Abiomed, AstraZeneca, Biotie, Boehringer Ingelheim, Daiichi-Sankyo, Eli Lilly & Company, Faculty Connection,
Gilead Sciences, Janseen Pharmaceuticals, Merck, Stealth Peptides, Medscape, The Medicines Company, and WebMD; and has
received research grant support from Daiichi-Sankyo, Eli Lilly & Company, Gilead Sciences, and Janssen Pharmaceuticals.
Dr. O’Neill has served as a consultant for Medtronic, Edwards Lifesciences, and St. Jude Medical. All other authors have reported
that they have no relationships relevant to the contents of this paper to disclose.

Manuscript received December 14, 2015; revised manuscript received January 29, 2016, accepted February 1, 2016.
872 Atkinson et al. JACC: CARDIOVASCULAR INTERVENTIONS VOL. 9, NO. 9, 2016

Algorithm for Mechanical Circulatory Support MAY 9, 2016:871–83

ABBREVIATIONS clinical scenario and to understand how pa- HR-PCI. The evolution of PCI with advances in
AND ACRONYMS tient characteristics impact this choice. The catheter design, creation of low profile balloons,
goal of this paper is to define a practical guidewire design, stent deliverability, and develop-
3VD = 3-vessel disease
approach for the interventional cardiologist ment of effective antiproliferative medications
CPR = cardiopulmonary
regarding when to use MCS, how to select have increased the number of patients eligible for
resuscitation
MCS device type, and practical points to percutaneous revascularization. According to recent
ECMO = extracorporeal
membrane oxygenation consider when utilizing MCS devices. American Heart Association statistics, although both

HR-PCI = high-risk
PCI and coronary artery bypass graft surgery
POPULATIONS REQUIRING
percutaneous coronary numbers have declined, PCI is the most common
intervention PERCUTANEOUS MECHANICAL
revascularization modality and is applied to
IABP = intra-aortic balloon
CIRCULATORY SUPPORT
patients with increased lesion complexity and com-
pump
orbidities with 51% of all PCI performed in patients
ICU = intensive care unit CARDIOGENIC SHOCK. Cardiogenic shock
>65 years of age (22). In addition, the advent of
MCS = mechanical circulatory occurs secondary to multiple etiologies
transcatheter techniques for the treatment of
support including left ventricular systolic dysfunc-
patients with valvular heart disease has resulted
ROSC = return of spontaneous tion, right ventricular systolic dysfunction,
in older patients with severe coronary disease and
circulation valvular heart disease, pericardial disease,
left ventricular systolic dysfunction undergoing
VA = venoarterial and vasodilatory abnormalities. These con-
HR-PCI. Multiple variables define HR-PCI including
ditions, in our patient population, most often present
clinical presentation, coronary anatomy, hemody-
in patients with acute myocardial infarction, out-of-
namic status, electrical instability and end organ
hospital cardiac arrest, and patients with a history
function (Table 3) (23,24). PCI in patients with
of congestive heart failure and/or advanced valvular
factors such as impaired left ventricular systolic
heart disease. While cardiogenic shock is one of the
function defined as ejection fraction <35%, un-
more fatal complications of acute myocardial infarc-
protected left main disease, severe 3-vessel disease
tion, it is relatively rare occurring in about 7% of all
(3VD) (SYNTAX score >33), or last remaining patent
acute myocardial infarctions (10,11). Even with
vessel are associated with in-hospital mortality rates
prompt reperfusion therapy with primary percuta-
between 5% and 15% (24–30).
neous coronary intervention, mortality rates still
MCS has been used to provide stability during high-
range from 30% to 50% (3). The SHOCK (SHould we
risk interventions for over 25 years. The goal of MCS
emergently revascularize Occluded Coronaries for
during HR-PCI is to provide sufficient forward cardiac
cardiogenic shocK?) trial outlined clinical and hemo-
output to maintain myocardial, cerebral, mesenteric,
dynamic criteria to define cardiogenic shock (Table 1).
renal, and peripheral tissue perfusion. Nellis et al. (31)
In clinical practice, patients with cardiogenic shock
have demonstrated in an animal model that a
represent a spectrum of disease secondary to
40 mm Hg pressure gradient exists between coronary
different etiologies, which can be classified as pre/
arterioles and venules. Sustained hypotension with
early shock, shock, and severe shock (Table 2) (12–21).
coronary perfusion gradients <40 mm Hg can lead to
Therefore, a structured approach to determine the
profound myocardial ischemia, which quickly de-
best adjunctive MCS device in patients undergoing
presses an already impaired left ventricle and may
percutaneous coronary intervention (PCI) is required.
lead to cardiovascular collapse and arrest. Clinicians
must recognize this scenario and act prior to reaching
T A B L E 1 Hemodynamic Criteria for Cardiogenic Shock
this threshold to avoid this lethal spiral. Measuring a
Clinical left ventricular end-diastolic pressure prior to PCI can
SBP <90 mm Hg for 30 min
help differentiate where the patient is on the spec-
Supportive measures needed to maintain SBP >90 mm Hg
trum of cardiogenic shock and determine whether
End-organ hypoperfusion
MCS is needed prior to PCI. MCS should be instituted
Cool extremities
UOP <30 ml/h prior to PCI in an effort to avoid “crashing onto sup-
HR >60 beats/min port” and to enable the most complete revasculariza-
Hemodynamic tion feasible. In the PROTECT II (Prospective, Multi-
Cardiac index <2.2 ml/min/m2 center, Randomized Controlled Trial of the IMPELLA
PCWP >15 mm Hg RECOVER LP 2.5 System Versus Intra Aortic Balloon
The SHOCK trial defined cardiogenic shock according the clinical and hemodynamic
Pump [IABP] in Patients Undergoing Non Emergent
criteria listed (11). High Risk PCI) trial, hypotensive events occurred less
HR ¼ heart rate; PCWP ¼ pulmonary capillary wedge pressure; SBP ¼ systolic
blood pressure; UOP ¼ urine output.
often in the Impella group (11.8% vs. 17.2%; p < 0.001).
Patients with the lowest major adverse events at
JACC: CARDIOVASCULAR INTERVENTIONS VOL. 9, NO. 9, 2016 Atkinson et al. 873
MAY 9, 2016:871–83 Algorithm for Mechanical Circulatory Support

T A B L E 2 Spectrum of Cardiogenic Shock T A B L E 3 High-Risk PCI

Pre/Early Shock Clinical

Clinical LVEF <35%
SBP <100 mm Hg Electrical instability
HR 70–100 beats/min Congestive heart failure
Normal lactate Comorbidities
Normal mentation Severe aortic stenosis
Cool extremities Severe mitral regurgitation
Hemodynamic Chronic obstructive pulmonary disease
CI 2–2.2 Chronic kidney disease
PCWP <20 Diabetes
LVEDP <20 Cerebrovascular disease
CPO >1 W Peripheral vascular disease
Vasoactive medications Age >75 yrs
0 or 1 low dose Acute coronary syndrome
Shock Coronary anatomy
Clinical Last patent vessel
SBP <90 mm Hg UPLMN
HR >100 beats/min 3 vessel disease, SYNTAX score >33
Lactate >2 Target vessel providing collaterals to a territory, which supplies
AMS >40% of the myocardium

Cool extremities Distal left main bifurcation

Hemodynamic
High-risk percutaneous coronary intervention (PCI) is defined in multiple clinical
CI 1.5–2.0 trials according to several key clinical features, comorbidities, and anatomical
PCWP >20 features that have shown to cause increased morbidity and mortality during PCI
Adapted with permission from Myat et al. (43).
LVEDP >20
LVEF ¼ left ventricular ejection fraction; UPLMN ¼ unprotected left main
CPO <1 W coronary artery.
Vasoactive medications
1 moderate to high dose
Severe shock
Clinical survival rates have increased over the last decade,
SBP <90 mm Hg improvements in management of cardiac arrest are
HR >120 beats/min warranted. The 2015 American Heart Association
Lactate >4 Updated Guidelines for cardiac arrest defines the
Obtunded
term ECPR as initiation of venoarterial ECMO
Cool extremities
(VA-ECMO) for cardiac arrest patients requiring
Hemodynamic
ongoing cardiopulmonary resuscitation (CPR), with
CI <1.5
PCWP >30
the goal to provide cardiopulmonary support while
LVEDP >30 spontaneous circulation is regained and reversible
CPO <0.6 W causes are identified and treated (33). Observational
Vasoactive medications studies have demonstrated improvements in return
2 or more of spontaneous circulation (ROSC), mortality, and

Cardiogenic shock can be classified as pre/early shock, shock, and severe shock, which
can help determine the appropriate mechanical circulatory support (MCS) device.
AMS ¼ altered mental status; CI ¼ cardiac index; CPO ¼ cardiac power;
LVEDP ¼ left ventricular end diastolic pressure; other abbreviations as in Table 1.
follow-up were those who had 2 or more vessels
revascularized (32).
CARDIOGENIC SHOCK AFTER CARDIAC ARREST
WITH AND WITHOUT RETURN OF SPONTANEOUS
CIRCULATION. Out-of-hospital cardiac arrest carries
a significant morbidity and mortality, with only 7% to
10% surviving to hospital discharge (33–35). Initial
presentation with ventricular tachycardia or ventric-
ular fibrillation is associated with improved survival
outcomes ranging from 25% to 30% (34). While
neurologic outcomes with ECPR; however, no ran-
domized trial data exists (36–39). While the new
guidelines do not support the routine use of ECPR, it
is now a Class IIb recommendation in patients with
cardiac arrest with ongoing CPR after 10 min.
PERCUTANEOUS MECHANICAL SUPPORT
DEVICES AVAILABLE AND TRIAL DATA
Three main MCS strategies are commonly utilized to
provide circulatory and left ventricular support.
Circulatory support increases mean arterial blood
pressure which improves vital organ perfusion while
left ventricular support reduces myocardial oxygen
demand by reducing left ventricular pressure and
874 Atkinson et al. JACC: CARDIOVASCULAR INTERVENTIONS VOL. 9, NO. 9, 2016

Algorithm for Mechanical Circulatory Support MAY 9, 2016:871–83

F I G U R E 1 Comparison of MCS Devices

A structured approach to determine the best adjunctive mechanical circulatory support (MCS) device required involves understanding the mechanisms, technical requirements,
and hemodynamic responses of each device. AO ¼ aorta; IABP ¼ intra-aortic balloon pump; LA ¼ left atrium; LV ¼ left ventricle; LVEDP ¼ left ventricular end diastolic
pressure; MAP ¼ mean arterial pressure; PCWP ¼ pulmonary capillary wedge pressure; RA ¼ right atrium; VA-ECMO ¼ venoarterial extracorporeal membrane oxygenation.

volume (Figure 1) (9,40–46). Although the most
extensive experience exists with the use of IABP, it
provides minimal hemodynamic support, which may
be insufficient to support more severe forms of
cardiogenic shock. Newer continuous flow devices
such as Impella (left ventricle / aorta)
TandemHeart (left atrium / femoral artery) offer
a greater level of left ventricular support (Figure 2)
(47). In the cardiovascular literature, VA-ECMO,
femoral vein to femoral artery cannulation with
extracorporeal oxygenation and nonpulsatile retro-
grade femoral artery bypass, has been used predom-
inantly in profound cardiogenic shock coupled with
respiratory failure and in cardiac arrest.
The use of MCS devices in HR-PCI and cardiogenic
shock has been studied in several randomized clinical
trials (Table 4) (7,20,23,30,39,48–57). IABP has been
studied extensively and has not reduced mortality in
patients with cardiogenic shock or HR-PCI except in
the setting of ST-segment elevation myocardial
infarction patients treated with fibrinolysis (3,58,59).
While randomized clinical trials have been too small to
demonstrate a mortality benefit with Impella
compared to IABP in patients with HR-PCI and cardio-
and genic shock, these studies have demonstrated superior
hemodynamic support and maintenance of cardiac
power (23). Cardiac power (product of mean arterial
blood pressure and cardiac output divided by 451)
represents an independent predictor of mortality in
the setting of cardiogenic shock, acute myocardial
infarction and severe left ventricular systolic
dysfunction (16,40). The FDA has recently approved
Impella devices for use in cardiogenic shock after acute
myocardial infarction or open heart surgery. Limited
randomized clinical trials for TandemHeart demon-
strate superior hemodynamic support compared to
IABP in the setting of cardiogenic shock (48,49).
Finally, while VA-ECMO provides excellent circulatory
JACC: CARDIOVASCULAR INTERVENTIONS VOL. 9, NO. 9, 2016
MAY 9, 2016:871–83
F I G U R E 2 Comparison of MCS Devices and Their Impact on Cardiac Flow
Four main families of devices exist for percutaneous MCS, which includes IABP, Impella (Abiomed Inc., Danvers, Massachusetts), TandemHeart
(CardiacAssist, Inc., Pittsburgh, Pennsylvania), and VA-ECMO. Each device provides a different level of cardiac flow and device selection should
be tailored to the level of support needed. Abbreviations as in Figure 1.
support, it has a higher vascular complication rate
compared to IABP; left ventricular venting is often
required to prevent increased myocardial oxygen de-
mand secondary to increased afterload, which can
precipitate further myocardial ischemia (55,56,60,61).
Despite the lack of randomized clinical trials, registry
data with ECMO has resulted in an increased applica-
tion in patients with cardiac arrest (47,62).
PRACTICAL APPROACH TO PERCUTANEOUS
MCS IN CARDIOGENIC SHOCK, HR-PCI, AND
CARDIOGENIC SHOCK AFTER CARDIAC
ARREST WITH AND WITHOUT ROSC
Cardiogenic shock, HR-PCI, and cardiac arrest patients
represent a wide spectrum of disease that requires
tailored therapy to improve individual hemodynamic
derangements. First, prompt recognition of patients
with cardiogenic shock and identification of patients
with high-risk features for PCI is essential. Once
identified, a multidisciplinary heart team approach, as
pioneered in the SYNTAX (SYNergy Between PCI With
TAXUS and Cardiac Surgery) and PARTNER (Place-
ment of AoRTic TraNscathetER Valve Trial Edwards
SAPIEN Transcatheter Heart Valve) trials, with inter-
ventional cardiology, cardiothoracic surgery, critical
care, and advanced heart failure physicians should be
initiated (63,64). The next step is to identify disease
severity from a PCI and/or shock perspective to
determine the most appropriate level of support. With
the advent of multiple devices, identifying which de-
vice to use can be challenging for the intervention-
alist. We created an algorithm to simplify decision
making in this challenging patient population, which
will be outlined subsequently (Central Illustration).
IDENTIFICATION OF CARDIOGENIC SHOCK AND
HR-PCI PATIENTS. Identification of hemodynamic
derangement can help define the level of shock.
Multiple critical care scores exist to predict the
Atkinson et al. 875
Algorithm for Mechanical Circulatory Support
severity of shock with the most familiar being the
APACHE II (Acute Physiology and Chronic Health
Evaluation II) score (12). In general, signs of hypo-
perfusion including altered mental status, decreased
urine output (<30 ml/h), elevated lactate, elevated
creatinine, elevated liver function tests, cool ex-
tremities, or hemodynamics refractory to medical
therapy and/or IABP correspond to severe shock
which requires the highest level of support (12–15).
Quick classification and resuscitation is required,
while consultation with the heart team and decision
for mechanical support is made.
In the setting of HR-PCI patients, identification
of patients with significant comorbidities, ejection
fraction <35%, last patent vessel, severe 3VD
(SYNTAX score >33), and unprotected left main dis-
ease is critical.
HEART TEAM APPROACH. First described in the
SYNTAX and PARTNER trials, the multidisciplinary
heart team has typically been comprised of inter-
ventional cardiologists and cardiothoracic surgeons
to participate in clinical decision making with revas-
cularization and valvular heart disease specifically
severe aortic stenosis (63–65). In the setting of
cardiogenic shock, the multidisciplinary heart team
should expand to include advanced heart failure and
intensive care physicians who will play an essential
role in the post-procedure management. The poten-
tial benefits of the heart team have not been evalu-
ated or clearly defined in a clinical trial, but may
include improved patient outcomes and system based
outcomes (65). Due to the emergent nature of
cardiogenic shock and requirement for quick inter-
vention, a heart team approach is not always feasible.
PATIENT ASSESSMENT/TECHNICAL ASPECTS/TIPS
AND TRICKS. Several technical requirements must be
considered prior to choosing a device for MCS
including identifying indications, contraindications,
876 Atkinson et al. JACC: CARDIOVASCULAR INTERVENTIONS VOL. 9, NO. 9, 2016

Algorithm for Mechanical Circulatory Support MAY 9, 2016:871–83

T A B L E 4 Contemporary Outcomes for MCS Devices

First Author/Trial
(Ref. #) Indication HR-PCI/Shock Definition N Devices Outcomes Complications

Burkhoff et al. (48) CS CI <2.2 l/min/m2, PCWP >15, end 42 IABP versus No difference in survival or
organ hypoperfusion (low UOP, TandemHeart 30-day adverse events.
AMS), high dose vasopressor or Better hemodynamics with
inotrope, failed IABP TandemHeart (CI, MAP)
Kar et al. (49) Severe CS SBP <90 mm Hg, CI <2 l/min/m2, 117 TandemHeart 30-day survival: 60% Bleeding around
end organ failure despite IABP/ (82% had IABP prior cannula sites 29%
pressors/inotropes to TandemHeart) Blood transfusions:
59.8%
Thiele et al. (57) CS in AMI SHOCK trial definition, 41 IABP ¼ 20 Superior hemodynamic Increased bleeding and
(95% PCI) lactate >2, CI <2.1 l/min/m2 TandemHeart ¼ 21 support with limb ischemia
TandemHeart:
[ CPI, Y lactate, PCWP
Similar 30-day mortality
Alli et al. (50) Prophylactic EF <30% with a Jeopardy score >8 54 TandemHeart 6-month survival: 87% 13% vascular
HR-PCI in which occlusion of the target complications
vessel(s) either transient or
permanent could result in
cardiogenic shock, CPR, or death
ISAR-SHOCK (51) Severe CS in AMI SHOCK trial definition 25 IABP versus Impella 30-day survival: 54% Hemolysis
in both
Superior hemodynamics
with Impella (CI, CPI)
USPella (30) Prophylactic Severe 3VD, UPLMN, last patent 175 Impella 2.5 12-month survival: 88% MACE: 8%
HR-PCI vessel, low EF
No STEMI or shock,
mean SYNTAX score 36
EuroPella (52) Prophylactic Severe 3VD, UPLMN, last patent 144 Impella 2.5 30-day survival: 94.5% MI: 0%, stroke 0.7%,
HR-PCI vessel, EF <30% bleeding 6.2%,
No STEMI or shock vascular
complication 4%
Protect I (7) HR-PCI Last patent vessel, UPLMN, 20 Impella 2.5 MACE 20%
EF <35%
No STEMI or shock
PROTECT-II (23) HR-PCI UPLMN, last patent vessel, 452 IABP (226) versus Superior hemodynamics MAE: MAE 30 & 90
EF <35%, 3VD, and EF <30% IMPELLA 2.5 (226) with Impella (CPO) days: (ITT)
No statistical difference in Impella: 35.1%, 40.6%
MAE IABP: 40.1%, 49.3%
Nichol et al. (54) CS and/or cardiac 1,494 VA-ECMO 50% survival to hospital Vascular injury,
arrest 84 studies discharge bleeding and stroke
ELSO registry (39) Cardiac arrest 75% cardiac disease 2,633: VA-ECMO 91% 27% survival to hospital Neurologic
295 ECPR discharge complications 33%
Takyama et al. (53) Refractory CS, SBP <90 mm Hg, CI <2.0 l/min/m2, 90 VA-ECMO 49% survival to hospital Bleeding and stroke:
23% active CPR evidence of end-organ failure discharge 26% and 18%
despite inotropes/vasopressors LV distention and
or IABP pulmonary edema
Teirstein et al. (55) HR-PCI and 1) Stable or unstable angina pectoris; 389: prophylactic CPS [ Procedural morbidity 7.2% required initiation
VA-ECMO 2) at least 1 coronary artery CPS prophylactic 41.3 versus of standby CPS
stenosis amenable to PCI; 3) 180: standby CPS 9.4% standby, no Standby CPS: provided
EF <25%; or 4) angioplasty improvement in excellent support
target vessel supplying >50% of outcome and recommended
the viable myocardium, or both over prophylactic
CPS
Schreiber HR-PCI Low EF, culprit vessel supplying the CPS: 58 IABP versus CPS No difference in MACE (MI, Increased vascular
et al. (56) majority of myocardium, or IABP: 91 stroke, death, CABG) repair with CPS
intended multivessel angioplasty Multivessel angioplasty (14 v. 3%)
success rates higher in Increased transfusion
CPS (40% vs. 20%) with CPS
(60 versus 27%)
Sheu et al. (20) AMI and CS Profound CS: SBP <75 mm Hg Group 1: 115 In Group 1 ECMO: 60.9% 30-day survival in PCI completed with
despite inotropes and IABP Group 2: 219 100% IABP, 25 ECMO group versus 28% stent in 70%
support, with AMS, oliguria, and profound CS, no 30-day survival in non-
respiratory failure requiring ECMO ECMO group
mechanical ventilatory support In Group 2: 46
profound CS þ
ECMO

Mechanical circulatory support (MCS) devices have been studied in cardiogenic shock (CS) and high-risk percutaneous coronary intervention (HR-PCI) in several randomized controlled trials and observational
studies. This is not a complete review of the literature for MCS devices in CS and HR-PCI, but highlights many of the important studies within this field.
3VD ¼ 3-vessel disease; AMI ¼ acute myocardial infarction; AMS ¼ altered mental status; CABG ¼ coronary artery bypass graft; CI ¼ cardiac index; CPI ¼ cardiac power index; CPO ¼ cardiac power;
CPR ¼ cardiopulmonary resuscitation; CPS ¼ cardiopulmonary support; ECMO ¼ extracorporeal membrane oxygenation; EF ¼ ejection fraction; IABP ¼ intra-aortic balloon pump; MACE ¼ major adverse
cardiac events; MAP ¼ mean arterial pressure; MI ¼ myocardial infarction; PCWP ¼ pulmonary capillary wedge pressure; SBP ¼ systolic blood pressure; STEMI ¼ ST-segment elevation myocardial infarction;
UOP ¼ urine output; UPLMN ¼ unprotected left main artery; VA-ECMO ¼ venoarterial extracorporeal membrane oxygenation.
JACC: CARDIOVASCULAR INTERVENTIONS VOL. 9, NO. 9, 2016 Atkinson et al. 877
MAY 9, 2016:871–83 Algorithm for Mechanical Circulatory Support

CENTRAL ILLUSTRATION Algorithm for Percutaneous MCS Device Selection in Patients with Cardiogenic Shock,
Cardiac Arrest, and HR-PCI

Atkinson, T.M. et al. J Am Coll Cardiol Intv. 2016;9(9):871–83.

3VD ¼ 3 vessel coronary artery disease; AS ¼ aortic stenosis; BiV ¼ biventricular; CI ¼ cardiac index; CPO ¼ cardiac power; EF ¼ ejection fraction; HR ¼ heart rate;
HR-PCI ¼ high-risk percutaneous coronary intervention; IABP ¼ intra-aortic balloon pump; LVEDP ¼ left ventricular end-diastolic pressure; MCS ¼ mechanical
circulatory support; MR ¼ mitral regurgitation; PCI ¼ percutaneous coronary intervention; PCWP ¼ pulmonary capillary wedge pressure; ROSC ¼ return of spontaneous
circulation; RVAD ¼ right ventricular assist device; SBP ¼ systolic blood pressure; UPLMN ¼ unprotected left main artery; VA-ECMO ¼ venoarterial extracorporeal
membrane oxygenation.

access site, and operator experience. Each device has
specific contraindications, which must be noted prior
to the procedure (Table 5) (9,43,66). While moderate
to severe aortic regurgitation and ventricular septal
defect are listed as contraindications to Tandem-
Heart, isolated case reports have used TandemHeart
for support in both settings (67,68).
Access remains a key issue with regard to technical
feasibility as these patients not only have severe
coronary atherosclerotic disease, but often have ilio-
femoral atherosclerotic disease as well, which creates
challenges secondary to vessel tortuosity and heavy
calcification. Pelvic angiography should be performed
to assess iliofemoral vasculature, but computed to-
mography pelvic angiography can be done as an
alternative for pre-procedural planning. If the iliofe-
moral arteries are not suitable for access, then
subclavian or axillary arterial access with an 8 to
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Algorithm for Mechanical Circulatory Support MAY 9, 2016:871–83

T A B L E 5 MCS Device Contraindications and Complications

IABP Impella TandemHeart VA-ECMO

Contraindications Moderate to severe AR LV thrombus Severe PAD Contraindications to

Severe PAD Mechanical aortic valve HIT anticoagulation
Aortic disease Aortic stenosis with DIC Moderate to severe AR
AVA <0.6 Contraindications to Severe PAD
Moderate to severe AR anticoagulation
Severe PAD LA thrombus
Contraindication to VSD
anticoagulation Moderate to severe AR
Complications Stroke Device migration Air embolism Bleeding
Limb ischemia Device thrombosis Thromboembolism Vascular trauma
Vascular trauma Limb ischemia Device Dislodgement Limb ischemia
Balloon rupture Vascular trauma Cardiac tamponade Compartment syndrome
Thrombocytopenia Hemolysis Limb ischemia Acute kidney injury
Acute kidney injury Infection Vascular trauma Hemolysis
Bowel ischemia Stroke Hemolysis Thromboembolism
Infection Infection Air embolism
Stroke Infection
Neurological Injury
Bleeding/hemolysis þ þþ þþ þþ
Vascular complications þ þþ þþþ þþþþ

Contraindications and complications must be reviewed prior to MCS device use in all patients and can vary according to device.
AR ¼ aortic regurgitation; AVA ¼ aortic valve area; DIC ¼ disseminated intravascular coagulation; HIT ¼ heparin-induced thrombocytopenia; LA ¼ left atrium; LV ¼ left
ventricle; PAD ¼ peripheral arterial disease; VSD ¼ ventricular septal defect; other abbreviations as in Table 4.

10 mm  20 cm vascular graft can be pursued to
facilitate Impella placement (69,70). Recently a
transcaval approach has been performed (71). Pre-
procedural planning when feasible with vascular
surgery or interventional radiology can provide
expert guidance to determine the best point of access
for each patient (Table 6) (70,72–75).
One must also consider the learning curve that ex-
ists with these devices reported by Henriques et al.
(76). In a pre-specified analysis in the PROTECT II trial,
which removed the operator’s placement of first IABP
and first Impella treated patient at each site from
analysis, there was a reduction of major adverse event
from 50% to 38% (p ¼ 0.029) at 90 days for Impella
supported patients (76). For this reason it is important
that if Impella or TandemHeart is used, that there is an
experienced team that inserts and works on this de-
vice. Institutional systems, team familiarity, post-
procedure recovery and device management must all
be taken into consideration when choosing a device.
Device escalation is often required if the initial
support device (usually IABP) does not improve he-
modynamics and end organ perfusion.
DEVICE SELECTION. P r e - s h o c k / s h o c k . In the set-
ting of pre-shock with systemic hypoperfusion with-
out a blood pressure <100 mm Hg, it may be reasonable
to use an IABP while performing PCI (21). Quick feed-
back loops incorporating patient status and hemody-
namics are required to assess the need for escalation of
support to an Impella, TandemHeart, or VA-ECMO. For
patients with shock, we recommend MCS with Impella.
We recommend repeat hemodynamic assessment 15 to
30 min after initial device placement. In the ISAR-
SHOCK (Efficacy Study of LV Assist Device to Treat
Patients With Cardiogenic Shock) trial, hemodynamics
in the IABP group noted a 0.11 increase in cardiac index
and decrease in diastolic blood pressure and mean
arterial pressure within 30 min while Impella 2.5 noted
an increase of 0.49 in cardiac index and increase in
mean arterial pressure within 30 min (51).
S e v e r e s h o c k . In patients meeting criteria for severe
cardiogenic shock, initial management requires
mechanical support devices including Impella (CP or
5.0) or TandemHeart, not an IABP. The Impella family
offers 2 different sizes devices that can be inserted
percutaneously (2.5 and CP) via the arterial circulation
and 5.0 which can be implanted transcavally (personal
communication, W.W. O’Neill, December 30, 2015) or
surgically. A multidisciplinary heart team consulta-
tion should be completed as further escalation for
surgical left ventricular assist devices or VA-ECMO
may be needed.
In the setting of cardiogenic shock secondary to
acute right ventricular systolic dysfunction, the main
options for hemodynamic support include Tandem-
Heart ProTek Duo (CardiacAssist, Inc., Pittsburgh,
Pennsylvania), Impella RP (Abiomed Inc., Danvers,
Massachusetts), and VA-ECMO (77,78). In patients
with biventricular failure, percutaneous options
include VA-ECMO or combination of percutaneous
right ventricular assist devices such as TandemHeart
or Impella RP with an Impella CP or 5.0 (79).
Cardiogenic shock after cardiac arrest with and
w i t h o u t R O S C . For the patients with profound
JACC: CARDIOVASCULAR INTERVENTIONS VOL. 9, NO. 9, 2016 Atkinson et al. 879
MAY 9, 2016:871–83 Algorithm for Mechanical Circulatory Support

H R - P C I . Pre-procedural planning is key to success

T A B L E 6 Tips and Tricks
when approaching complex, high-risk interventions.
Vascular access
With the use of MCS, the term “protected PCI” is now
Femoral
the mainstay for complex coronary revascularization.
Micropuncture needle
Ultrasound guidance For patients undergoing protected PCI, randomized
Benefit: anterior stick above femoral bifurcation data and registry information has not demonstrated a
Stiff wire: for sheath delivery in morbidly obese, tortuous benefit of IABP (Table 7) (3–5,58,59,81,82). Impella
anatomy or heavy calcification
support, however, enhances 90-day major adverse
Amplatz Extra Stiff
event free survival compared to IABP protected
Amplatz Super Stiff
patients (23). The mechanism for this benefit appears
Backup Meier
Axillary/subclavian to be related to greater support of cardiac power and
Surgical placement: 8–10 mm x 20 cm vascular graft reduction in hypotensive events during PCI for Impella
Severe tortuosity protected patients. Given the results of the PROTECT II
Lunderquist Extra Stiff Wire (if prior wires have failed) trial, Impella 2.5 is approved for the use in HR-PCI. In
13/14-F 30 cm Cook Check Flo Sheath higher risk patients and complex anatomy requiring
Vascular closure
prolonged balloon inflations or adjunct therapies that
Pre-close technique

may precipitate significant myocardial ischemia the
Deployment of 2 Perclose ProGlide devices 90 apart (10 o’clock
and 2 o’clock) prior to large bore sheath insertion Impella CP should be considered. Given that HR-PCI is
Manual often performed electively, pre-procedural planning
Femostop under patient prior to sheath removal for emergency including a heart team approach is essential; ad-hoc
use
HR-PCI should be limited to unstable patients.
45-min compression
2 physicians present at bedside
POST-PROCEDURE CARE. A critical aspect to MCS, is
Vascular surgery device management post-procedure when transferring
Surgical repair to an intensive care unit (ICU) and weaning the device
Device escalation in the setting of HR-PCI. Establishment of appro-
IABP removal priate training and protocols within each institution is
Obtain contralateral access
critical to continued hemodynamic support of patients
Place Impella in contralateral artery
with cardiogenic shock or HR-PCI post device place-
Place IABP on standby
ment. Cardiogenic shock requires a multidisciplinary
Pull back balloon until it reaches the end of the sheath
Slowly remove balloon through sheath team approach as patients can now be supported
If unable to remove through sheath, a 0.025” exchange length with left ventricular assist devices over prolonged
wire or 0.018” Platinum Plus wire can be placed through the periods to allow decisions regarding permanent left
balloon pump lumen.
Remove the sheath and balloon as one leaving the wire in place.
ventricular assist devices or cardiac transplantation.
Upsize sheath by 0.5- to 1-F size Another important consideration is anticoagulation
Closure device can then be deployed or sheath can be used for management and hemolysis. While hemolysis is rare,
further arterial access for PCI if indicated platelet counts, hemoglobin and hematocrit should be
Meticulous access is required to limit vascular complications. Several tips and
followed on a daily basis. Anticoagulation protocols
tricks are outlined to provide guidance for successful device placement. should be implemented with appropriate bleeding
Abbreviations as in Table 4.
reduction strategies.
The long-term use of support devices increases the
cardiopulmonary failure (left ventricular and/or risk for complications. Each device has specific com-
biventricular) including respiratory failure with dif- plications that require different treatments (Table 5)
ficulty maintaining oxygenation/ventilation or (9,43,66). Device migration is one of the most com-
ongoing cardiopulmonary resuscitation, the use of mon issues encountered with both the Impella and
VA-ECMO should be considered in centers with TandemHeart and can be associated with poorer
dedicated ECMO teams. VA-ECMO provides total cir- outcomes. This is a less common issue with the IABP.
culatory support and can achieve a circulatory flow Patient immobilization with femoral cannulation and
rates up to 7 l/min. A dedicated perfusionist is dedicated nursing staff familiar with these issues
required. However, the use of this device can be are essential.
associated with left ventricular distention and DEVICE WEANING AND REMOVAL. Weaning pro-
adequate techniques for venting the left ventricle tocols are at the discretion of the physician and should
may be simultaneously required (i.e., IABP, Impella, be created for each institution. In the setting of HR-
veno-veno-arterial ECMO, biatrial cannulation) PCI, weaning may occur in the cardiac catheteriza-
(60,80). tion laboratory. If an IABP is in place, we recommend
880 Atkinson et al. JACC: CARDIOVASCULAR INTERVENTIONS VOL. 9, NO. 9, 2016

Algorithm for Mechanical Circulatory Support MAY 9, 2016:871–83

T A B L E 7 Contemporary Trials With IABP

Trial/First Author Control or No Prophylactic or

(Ref. #) Indication Definition N IABP Survival IABP Survival Routine Use

IABP-SHOCK-II (3) AMI and CS SBP <90 mm Hg for >30 min 600 41.3% 39.7% No difference in survival
or vasoactive medications
needed to maintain SBP
>90, pulmonary edema,
end-organ dysfunction
(AMS, cool extremities,
UOP
<30 ml/h, lactate >2)
TACTICs (59) AMI and CS s/p fibrinolysis 57 67% at 30 days 73% at 30 days No significant difference
Killip III/IV: 20% at Killip III/IV: 61% at except in Killip III/IV
6 months 6 months patients who received
IABP
Waksman et al. (58) AMI and CS s/p fibrinolysis 45 19% 46% In-hospital survival
improved with IABP use
in patients s/p
fibrinolysis
NRMI (81) AMI and CS Observational study: IABP IABP ¼ 7,268 Lytics: 67% Lytics: 49% in-hospital IABP provided substantial
compared to no IABP No IABP ¼ 15,912 in-hospital mortality benefit in patients with
among patients given mortality PTCA: 47% in-hospital AMI and CS who
fibrinolysis or primary PTCA: 42% mortality received fibrinolysis
angioplasty in-hospital
mortality
CRISP-AMI (5) Anterior MI with Prophylactic IABP 337 No difference in No difference in No reduction in infarct size
planned PCI survival survival
NCDR (82) High risk including UPLMN, CS, severely 181,599 No difference in No difference in
STEMI and CS depressed EF (<30%), or mortality mortality
STEMI
BCIS-1 (4) HR-PCI EF <30%, severe CAD: 301 No difference in No difference in Increase minor bleeding in
jeopardy score >8, no survival survival IABP arm
shock or STEMI Decreased periprocedural
complications in IABP
(decreased
hypotension)
Elective IABP at 5 yrs
associated with RRR
34% for all-cause
mortality

A nonexhaustive review of the literature for IABP use in cardiogenic shock and HR-PCI.
CAD ¼ coronary artery disease; lytics ¼ fibrinolytics; PTCA ¼ percutaneous transluminal coronary angioplasty; RRR ¼ relative risk reduction; s/p ¼ status post; other abbreviations as in Table 4.

placing the patient on 1:2 for 10 min, followed by 1:3 for
10 min. If stable for 10 min, the device can be removed.
Abiomed provides 2 general weaning strategies with a
rapid and slow weaning protocol for the Impella de-
vices (70,74,83). In the setting of HR-PCI, the rapid
weaning protocol can be used which consists of
decreasing the level of support by 2 levels at a time
every 10 min until P2. If the patient remains stable on
level P2 for 10 min, then the device can be removed. At
the time of device removal, the device is turned down
to P1 and the Impella pulled back into the descending
thoracic aorta. Once in the descending thoracic aorta,
the device can be turned off completely to P0 and
removed. In most cases, the device can be removed
safely at the end of the case.
In the ICU weaning is best accomplished over
several hours, and should begin immediately in pa-
tients that demonstrate hemodynamic improvement
with MCS and have good end organ perfusion and
function. An IABP should be weaned with initial
reduction in assisted beats from 1:1 to 1:2 to 1:3 over
several hours. If stable on 1:3 for 3 h, the device
should be set at 1:1 and the heparin infusion should be
stopped for device removal once the PTT is <50 s.
Impella should be weaned over several hours with
reduction in level of support by 2 levels every 2 to 3 h
until level P2. Once stable at level P2 for 2 to 3 h the
device can be removed. After the device has been
removed, the patient is vulnerable and may require
reinsertion of a device, which can be difficult after all
access sheaths are removed.
Interventional cardiologists must become facile
with large bore sheath vascular closure techniques.
Arterial access can be closed utilizing the pre-close
technique, surgical closure, or manual pressure
(Table 6). Although manual hemostasis can be
achieved, it should not be the default technique. The
pre-close technique is the preferred strategy (72,75).
JACC: CARDIOVASCULAR INTERVENTIONS VOL. 9, NO. 9, 2016 Atkinson et al. 881
MAY 9, 2016:871–83 Algorithm for Mechanical Circulatory Support

IMPLEMENTATION OF A SUCCESSFUL scenarios for the use of various percutaneous MCS

PERCUTANEOUS MECHANICAL
CIRCULATORY SUPPORT PROGRAM
With multiple MCS devices available, each institution
must develop a strategy for the preferred MCS device
for patients with adequate training of cardiac cathe-
terization and ICU staff. A critical aspect of device
management involves unification of cardiac cathe-
terization staff, coronary care intensivists and nurses,
interventional cardiologists, advanced heart failure
cardiologists, and cardiothoracic surgeons to create
an operational strategy for each institution. This fa-
cilitates protocols that can be used and executed in a
timely manner and assist in especially for trouble-
shooting issues or complications. Ideally, this team
should also review the outcomes for all patients
treated with left ventricular support devices to
tabulate and evaluate complications as well as iden-
tify process improvement areas.
Interventional cardiology and cardiac catheteriza-
tion expertise is critical to the success of a per-
cutaneous MCS program. As noted previously, a
significant learning curve exists; each institution
should become familiar with at least 2 levels of sup-
port including IABP and Impella or TandemHeart in
order to provide safe and efficient delivery of care in
patients with HR-PCI and cardiogenic shock. Invest-
ment in training the interventionalist and cardiac
catheterization team will improve patient care and
hemodynamic support with the use of MCS.
devices in the setting of HR-PCI, cardiogenic
shock, and cardiac arrest.
2. Technical considerations must be taken into ac-
count with regards to access, indications, and
contraindications of each device.
3. A multidisciplinary heart team involving inter-
ventional cardiology, cardiothoracic surgery,
intensive care, and advanced heart failure physi-
cians should be utilized for decision-making pro-
cesses when time permits and for post-device
management.
4. Adequate training of the interventional cardiolo-
gist, cardiac catheterization laboratory staff, and
ICU staff must be performed for MCS program to
succeed.
REPRINT REQUESTS AND CORRESPONDENCE: Dr.
Joaquin E. Cigarroa, MD, Knight Cardiovascular
Institute, Cardiovascular Division, UHN-62, Oregon
Health & Science University, 3181 Southwest Sam
Jackson Park Road, Portland, Oregon 97239. E-mail:
cigarroa@ohsu.edu.
PERSPECTIVES
WHAT IS KNOWN? Mechanical circulatory support devices
have been used for decades to support patients in cardiogenic
shock or patients undergoing high-risk percutaneous coronary
intervention. Newer devices offer a greater level of hemody-
namic support, but device selection can often be challenging.

CONCLUSIONS WHAT IS NEW? An algorithm was created to guide interven-

The use of mechanical support devices has undergone
dramatic changes in the last decade when applied to
patients undergoing HR-PCI including those pre-
senting with cardiogenic shock or cardiac arrest. Cli-
nicians must quickly assess clinical presentation,
hemodynamics, and anatomy to determine the most
appropriate MCS device.
1. We created an algorithm to help guide interven-
tional cardiologists on the appropriate clinical
tional cardiologists in clinical decision making for choosing
mechanical circulatory support devices in patients undergoing
percutaneous coronary intervention with high risk features or
cardiogenic shock.
WHAT IS NEXT? Despite the ability to provide superior
hemodynamic support, this has not translated into improved
clinical outcomes. Further studies are needed to understand this
discrepancy.

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KEY WORDS cardiogenic shock, high-risk
percutaneous coronary intervention,
mechanical circulatory support