Online Appendix
Percutaneous Circulatory Assist Devices in High-Risk Percutaneous Coronary Intervention – The Current Evidence Base
IABP Registries
Trial
Name/Study
Group
Recruitment
Period
Brodie et al.
(1)
1984-1997
Sample
Size
1490
Study Cohort
Intervention
Consecutive patients with
AMI treated by primary
PTCA
(Timing of Circulatory
Support)
IABP implantation was at
the discretion of the
operator.
Registry
Analysis
IABP was used in 213
patients (14.2%):
 133 patients with CS
or CHF and
 80 hemodynamically
stable high-risk
patients.
High Risk Criteria
Efficacy
Safety
High risk factors
were identified as:
 CS
 CHF or
 LVEF ≤30%
IABP used before PTCA
was associated with fewer
catheterization laboratory
events in:
 patients with CS (14.5%
vs. 35.1%, p=0.009),
 patients with CHF or
low EF (0% vs. 14.6%,
p=0.10), and
 all high-risk patients
combined (11.5% vs.
21.9%, p=0.05).
IABP was associated with
an increased risk of major
bleeding (p<0.0001) and
stroke (p=0.001).
(MCS pre and post
PTCA)
Barron et al.
(2)
NRMI-2
Registry
1994-1998
23,180
AMI patients in CS on
arrival (25%) or later
development of CS
IABP n=7268 (31%)
No IABP n=15912
(MCS timing not
available)
This could be explained by
greater severity of illness in
patients treated by IABP.
IABP was a significant
independent predictor of
freedom from
catheterization laboratory
events (OR 0.48; 95% CI
0.29-0.79).
AMI + CS
Mortality rates:
Risk factors
associated with
increased mortality:
 advanced age
 diabetes
 prior AMI
 prior CABG
 increased HR
 anterior MI




TT + IABP = 48.7%
TT alone = 66.9%
Primary PTCA + IABP
= 46.5%
Primary PTCA alone =
42%
IABP was associated with
increased mortality when
used in primary PTCA
Not available.
patients (OR 1.26; 95% CI
1.07-1.50).
IABP Registries
Trial
Name/Study
Group
Recruitment
Period
Stone et al.(3)
1996-2001
Sample
Size
22,663
Benchmark
Registry
Study Cohort
Intervention
Consecutive patients
presenting with AMI in
whom an IABP was
implanted (n=5495)
(Timing of Circulatory
Support)
Diagnostic catheterization
was performed in 5348
(97.3%) patients, and 4476
(81.5%) underwent
coronary revascularization
before hospital discharge.
(MCS pre and post PCI)
Cohen et al.
(4)
Benchmark
Registry
1996-2001
22,663
Any patient who received
IABP was entered in this
registry.
Comparing characteristics of
US patients (n=19636)
undergoing IABP
implantation vs. non-US
patients (n=3027).
Any patient receiving an
IABP at a participating site
was included in the
registry.
(MCS pre and post PCI)
High Risk Criteria
Efficacy
Safety
Indications for IABP:
 CS (27.3%)
 high-risk PCI
(27.2%)
 mechanical
complications of
AMI (11.7%)
 refractory UA
post MI (10.0%)
 refractory LVF
(4.5%)
 refractory VA
(1.3%)



All cause, risk-adjusted, inhospital mortality (20.1% vs.
28.7%; p<0.001), and
mortality with IABP in place
(10.8% vs. 18.0%; p<0.001)
were lower at US vs. nonUS sites.





support and
stabilization for
angiography and
angioplasty
CS
refractory UA
refractory LVF
MI
complications
intractable VA


IABP-related mortality
0.05%
overall mortality 20%
deaths occurring whilst
IABP in situ 53%






After multiple logistic
regression analysis patients
in non-US institutions were
at higher risk for mortality.
any access site
bleeding 4.3%
any limb ischemia
2.3%
transfusion 1.4%
infection 0.1%
systemic embolism
0.1%
stroke 0.1%
any IABP failure 2.3%
In US and non-US
institutions, IABPassociated complication
rates, such as IABP-related
mortality (0.05% vs.
0.07%), major limb
ischemia (0.9% vs. 0.8%),
and severe bleeding (0.9%
vs. 0.8%) were low.
Ferguson et al.
(5)
1996-2000
16,909
Benchmark
Registry
Prospectively gathered
individual patient case
records on indications for
and complications of IABP
use.
Most frequent indication
for IABP was to provide
hemodynamic support
during or after cardiac
catheterization (20.6%).
13020 (77%) patients
underwent catheterization.
4833 (28.6%) patients
underwent PCI.





CS
refractory UA
refractory
ventricular
failure
mechanical
complication of
AMI
ischemia related
to intractable VA
The incidence of in-hospital
mortality related to IABP
was 0.05%.
Overall in-hospital mortality
for this cohort was 21.2%.
Overall mortality with IABP
in situ was 11.6%.
(MCS pre and post PCI)
Recorded complications:
 amputation (0.1%)
 major limb ischemia
(0.9%)
 access site bleeding
(2.4%)
 balloon leak (1.0%)
Major IABP complications:
2.8%
Any IABP
complicaitons:7.0%
Female gender, age ≥75
years, PVD, and BSA
<1.65 m2 were independent
predictors of major IABP
complications.
IABP Registries
Trial
Name/Study
Group
Recruitment
Period
Urban et al.
(6)
1997-2002
Sample
Size
27,132
Study Cohort
Intervention
Any patient receiving IABP
was entered into the
database.
(Timing of Circulatory
Support)
In-hospital mortality
analysis divided patients
into three groups:
Benchmark
Registry



surgical intervention
PCI
medical intervention
only
High Risk Criteria
Efficacy
Safety
Indications for the
PCI group:
In-hospital mortality for the
PCI group:
Complications for the PCI
group:










CS (25.4%)
Support in the
cath lab (52.9%)
UA (7.9%)
total 18.8%
IABP in place 10.4%
IABP-attributed
mortality <0.1%

any 8.2%
major 2.6%
limb ischemia 0.4%
severe access site
bleeding 1.5%
IABP leak 0.7%
(MCS pre and post PCI)
Zeymer et al.
(7)
2005-2008
653
AMI complicated by CS in a
prospective registry of 176
centers in 33 countries in
PCI with IABP support for
CS following STEMI and
NSTEMI.



STEMI
NSTEMI
CS
In-hospital mortality:
Non-fatal stroke:


with IABP 56.9%
with IABP 0.5%
Europe and the
Mediterranean Basin.
EuroHeart
Survey
PCI-Registry
Curtis et al.
(8)
2005-2007
181,599
Consecutive admissions for
high-risk PCI
NCDR
CathPCI
Registry


Of the 653 patients
identified with CS post
AMI, 24.8% were treated
with IABP.
(MCS timing not
available)
IABP for high-risk PCI
was used in 18990
(10.5%) procedures.
After multivariate
analysis, factors strongly
associated with IABP use
were:





without IABP 36.1%
OR 1.47, 95% CI 0.972.21, p=0.07

Major bleeding:


High-risk was
defined as 1 or more
of:




Unprotected
LMCA PCI
CS
LVEF <30%
STEMI
In-hospital mortality in the
IABP study cohort was
4.9% and after adjustment
for differences in patient and
hospital characteristics, did
not vary across hospitals
categorized by frequency of
IABP use.
with IABP 8.5%
without IABP 5.3%
Of the entire study sample,
those that received IABP
suffered the following:






CS
LVEF
NSTEMI
heart failure on
admission
admission status
without IABP 0.8%
bleeding 4.8%
access site occlusion
0.1%
peripheral
embolization 0.1%
dissection 0.3%
pseudoaneurysm 0.4%
AV fistula 0.1%
(MCS timing not
available)
IABP Retrospective Analyses
Trial
Name/Study
Group
Recruitment
Period
Sample
Size
Study Cohort
Intervention
(Timing of Circulatory
Support)
High Risk Criteria
Efficacy
Safety
Kahn et al.
(9)
1987-1990
28
Consecutive high-risk
PTCA patients
Retrospective
Analysis
Elective high-risk PTCA
and IABP.

(MCS pre PTCA)





O’Murchu et
al. (10)
1993-1994
159
Consecutive high-risk
patients undergoing
rotational atherectomy
Group 1 (n=28): Elective
IABP pre-PTCA



Group 2 (n=131): no IABP
Retrospective
Analysis
(MCS pre PTCA)


Briguori et al.
(11)
Retrospective
Analysis
1998-2000
133
Consecutive series of
patients undergoing elective
PCI for single-vessel
coronary artery disease.
Prophylactic IABP prior to
elective PCI (n=61) vs. no
IABP (n=72).
(MCS pre PCI)
severe LV
systolic
dysfunction
multivessel
disease
LMCA disease
advanced age
previous CABG
last remaining
conduit
No deaths or MI occurred
within 72 hours of coronary
angioplasty.

LVEF ≤35%
LMCA PTCA
myocardium at
risk
ostial/proximal
LAD lesion
multivessel
disease
Procedural success seen in
all IABP-supported patients.
Elective IABP insertion
was the
only variable to correlate
with a
successful procedure
uncomplicated by
hypotension
(p<0.05).
LVEF ≤30% in all
cases plus
one of:
 Jeopardy Score ≥8
 ongoing ischemia
 significant disease
in a vessel giving
collaterals to a
totally occluded
second vessel that
in turn supplies
blood to at least
40% of the LV
myocardium
 left main
equivalent stenosis
Non-Q wave MI post
atherectomy occurred only
in Group 2. (27% vs. 0%).
5 patients in Group 2
required salvage IABP for
procedural hypotension.
Elective IABP insertion was
associated with a significant
reduction in intra-procedural
MACCE (0% vs. 17%,
p=0.001).
Using logistic regression
analysis the investigators
demonstrated that elective
IABP support, Jeopardy
Score >6, and female sex
were the principal
determinants of intraprocedural events.

Limb ischemia in 2
patients
Pseudoaneurysm in 1
patient
Hospital stay and vascular
complications were similar
in both
groups.
There was no difference in
vascular complications
between
the two groups, the
incidence of
which was low overall.
Voudris et al.
(12)
1987-1988
1385
PTCA
Retrospective
Analysis
Prophylactic IABP in 27
procedures of the study
sample.



LVEF <40%
advanced age
multivessel
disease
No deaths, MI or emergency
bypass operations in the
hospitalization period.
If revascularization is
warranted in high-risk
patients, coronary
angioplasty can be
performed safely and
successfully with protection
by IABP.
(MCS pre PTCA)
IABP Retrospective Analyses
Trial
Name/Study
Group
Recruitment
Period
Ishihara et al.
(13)
1984-1990
Sample
Size
114
Retrospective
Analysis
Study Cohort
Anterior AMI patients
undergoing emergency
PTCA for total LAD artery
occlusion
Intervention
High Risk Criteria
Efficacy
Safety
(Timing of Circulatory
Support)
PTCA alone vs. PTCA
followed by IABP



Vascular complications
from IABP occurred in
only 2 patients.
AMI
LAD artery
occlusion

(MCS post PTCA)

Kreidieh et al.
(14)
1992
21
Consecutive high-risk
PTCA patients
Retrospective
Analysis
Arceo et al.
(15)
Retrospective
Analysis
1989-1996
201
Consecutive patients
receiving IABP implantation
at a single center.
Elective high-risk PTCA
and IABP.


(MCS pre PTCA)


PTCA was performed in
106 of 212 procedures
(50%) either before or
after IABP insertion:
 47% emergent
 3% elective

(MCS pre and post
PTCA)



ACS
multivessel
disease
EF 10-30%
VF at
angiography
AMI (67%)
including
mechanical
complications of
AMI
severe LVF
without AMI
(20%)
DCM (4%)
UA (3%)
No difference in inhospital mortality
IABP was associated
with a significantly
lower reocclusion rate
(2.4% vs. 17.7%,
p<0.05)
Trend to greater
increase in LVEF with
IABP (p=0.08)
Satisfactory primary success
rate.
Local hematoma in 2
patients.
No angioplasty-related
death.
Overall cohort in-hospital
mortality was 45%.
Overall complication rate
10.4%.
IABP successfully inserted
in 99.5% of attempts.




Limb ischemia
Septicemia and limb
amputation
Major and minor
bleeding
Balloon rupture
requiring vascular

Abdel-Wahab
et al. (16)
2005-2008
48
Patients undergoing primary
PCI for AMI complicated by
CS.
Retrospective
Analysis
IABP before PCI (n=26)
vs. IABP support after PCI
(n=22).


high-risk
supported PTCA
(2%)
STEMI
CS
IABP left for 48 hours at a
rate of 1:1.
(MCS pre and post PCI)
Mishra et al.
(17)
2000-2004
114
Consecutive patients
undergoing elective highrisk PCI.
Retrospective
Analysis
 ACS with
hemodynamic
stability
 CHF
vs.
 LVEF ≤30%
 MVD
PCI followed by rescue
 LMCA
“R-IABP” due to a
intervention
complication of the
 PCI of ≥1 SVG
procedure (n=46).
lesions
 PCWP >15 mmHg
(MCS pre- and peri-PCI)
and/or
 mean PAP >50
mmHg
High-risk PCI supported
by prophylactic “P-IABP”
(n=68)
surgery
In-hospital mortality:
 IABP pre-PCI: 19%
 IABP post-PCI: 59%
 p=0.007
There was no significant
difference in bleeding
between the treatment arms
(p=0.48).
Overall MACCE:
 IABP pre-PCI: 23%
 IABP post-PCI: 77%
 p=0.0004
Independent predictors of
in-hospital mortality:
 renal failure
 IABP post PCI

P-IABP was associated with
significantly lower rates of
in-hospital mortality
(p<0.01), non-Q-wave MI
(p<0.01), and major
complications (p<0.01). This
difference extended to 30
days.
At 6-month follow-up the
mortality (p<0.01) and
MACE rates (p=0.02)
remained significantly lower
in the P-IABP arm.
Local vascular
complications were
generally low and
comparable between both
treatment arms.
Major bleeding and a fall in
hematocrit were
significantly higher in the
R-IABP arm (p=0.018).
IABP Randomized Trials
Trial
Name/Study
Group
Recruitment
Period
Stone et al.
(18)
1993-1995
PAMI-II Trial
RCT
Sample
Size
437
Study Cohort
Patients presenting within
12 hours of pain onset and
EKG evidence of acute
STEMI.
Those patients with STsegment depression, LBBB,
or other non-diagnostic
Intervention
(Timing of Circulatory
Support)
PTCA of the IRA only.
Stenting (1.3%) and
atherectomy (1.2%) were
rarely performed.
Following PTCA patients
deemed high-risk were
High Risk Criteria






STEMI
age >70 years
three-vessel disease
LVEF ≤45%
vein graft occlusion
malignant
ventricular
Efficacy
Safety
No significant difference in
the primary combined
endpoint of death,
reinfarction, IRA
reocclusion, stroke, newonset heart failure or
sustained hypotension
(IABP 28.9% vs. no IABP
IABP use was associated
with a significant difference
in access site hemorrhage
(IABP 20.9% vs. no IABP
13.3%, P=0.03), which
primarily drove an overall
increase in hemorrhagic
complications (36.0% vs.
changes were included if
angiography revealed an
occluded vessel with
regional LV dysfunction.
eligible for randomization
to IABP for 36–48 hours
(n=211) vs. conservative
management (n=226).
arrhythmias
 suboptimal PTCA
result
29.2%, P=0.95).
27.4%, P=0.05).
No difference was seen in
the rate of blood
transfusion, fall in
hematocrit or major
vascular complications.
(MCS post PTCA)
IABP was associated with
an increased risk of stroke
(2.4% vs. 0%, P=0.03).
van’t Hof et
al. (19)
1993-1996
238
RCT
Patients aged ≤70 years
transferred for primary or
rescue PCI within 3 hours of
symptom onset and
cumulative STD >20 mm.
Randomized to 48 hours of
elective IABP vs. no IABP
after PTCA.

STEMI
(MCS post PTCA)
No significant difference in
the primary combined
endpoint of death, recurrent
MI, stroke or LVEF <30%
at 6-month follow-up (IABP
26% vs. no IABP 26%,
P=0.94).
There was significant
crossover in both treatment
arms (IABP to no IABP
25% vs. no IABP to IABP
31%).
Randomized
IABP Study
Group (20)
RCT
1989-1992
182
Consecutive patients
undergoing emergency
cardiac catheterization
within 24 hours of AMI
onset
Patients randomized to
IABP (n=96) vs. standard
therapy (n=86)
immediately after
emergency catheterization.
IABP was continued for
48 hours at a rate of 1:1.
(MCS post PTCA)

AMI
N.B. Patients
excluded if they
presented with:
 CS
 hypotension
resistant to fluid
or pressors
 pulmonary
edema requiring
IABP
IABP group was associated
with a significantly lower
re-occlusion rate of the IRA
(8% vs. 21%, p<0.03).
Composite clinical endpoint
of death, stroke, reinfarction, need for
emergency
revascularization, or
recurrent ischemia lower in
IABP arm (13% vs. 24%,
p<0.04).
Serious complications
occurred in 8% of patients
receiving IABP such as:




limb ischemia
hemorrhage
groin hematoma
infection
Rate of major hemorrhagic
complications similar in
both groups.
Similar rates of transfusions
between both groups.
IABP Randomized Trials
Trial
Name/Study
Group
Recruitment
Period
Prondzinsky
et al. (21)
2003-2004
Sample
Size
45
Study Cohort
Intervention
High Risk Criteria
Efficacy
Safety
AMI complicated by CS
(Timing of Circulatory
Support)
Patients randomised to
primary PCI with or
without IABP support



The addition of IABP to
standard therapy did not
result in a significant
improvement in multiple
organ dysfunction
syndrome.
Not measured.
IABPSHOCK
STEMI
NSTEMI
CS
IABP n=23
No IABP n=22
RCT
IABP continued for a
minimum of 48 hours.
IABP use had no significant
effect on cardiac index or
systemic inflammatory
activation, although BNP
levels were significantly
lower in IABP-treated
patients.
(MCS timing not
available)
Vijayalakshmi
et al. (22)
RCT
Not
recorded
33
Patients undergoing
emergency or urgent
angiography for STEMI or
NSTEMI with a view to
angioplasty who fulfilled the
randomization criteria.
Predefined high-risk, but
not CS, patients
randomized to IABP for
48 hours or no IABP
following PCI.
(MCS post PCI)
 BP <100 mmHg
but excluding CS
 pulse rate >100
bpm
 TIMI 0, 1, or 2
flow post
procedure
 persistent ST
elevation post
procedure
 clinical features of
LVF
IABP implantation was not
associated with a significant
improvement in coronary
blood flow in the culprit and
the non-culprit vessels
immediately post PCI.
There was also no
improvement in LV
function, ST-segment
recovery or overall clinical
outcome.
No significant hemorrhagic
complications in either
study arm.
Gu et al. (23)
2005-2009
106
Consecutive patients
undergoing high-risk PCI.
Prophylactic IABP (n=51)
vs. No IABP (n=55)
RCT
Mean duration of IABP
insertion was 52 ± 17
hours.




LVEF ±30%
LMCA PCI
clinical LVF
STEMI
(MCS pre PCI)


IABP was associated
with significantly
reduced in-hospital
mortality (p=0.032).
IABP was associated
with a significantly
reduced 30-day
mortality (p=0.022).

There were no
significant differences
in the rate of bleeding
(p=0.15) or vascular
complications
(p=0.276) between the
groups.
IABP Randomized Trials
Trial
Name/Study
Group
Recruitment
Period
Perera et al.
(24,25)
2005-2009
BCIS-1
RCT
Sample
Size
301
Study Cohort
Elective insertion of IABP
before high-risk PCI.
Those in CS, within 48
hours of MI, with
contraindication to IABP or
with class I indications for
IABP therapy were excluded
Intervention
(Timing of Circulatory
Support)
Patients were randomized
to receive elective IABP
insertion prior to PCI or to
have no planned IABP
insertion.
n=151 elective IABP
n=150 no planned IABP
(MCS pre PCI)
High Risk Criteria
Efficacy
Safety


MACCE at hospital
discharge:
 elective IABP: 15.2%
 no planned IABP:
16.0%
 OR 0.94, 95% CI 0.511.76, p=0.85
Major and minor bleeding:
 elective IABP: 19.2%
 no planned IABP:
11.3%
 OR 1.86, 95% CI 0.933.79, p=0.06


LVEF ≤30%
BCIS-1 jeopardy
score ≥8
LMCA stenosis
target vessel that
provides
collateral supply
to an occluded
second vessel
which in turn
supplies >40%
of myocardium
All-cause mortality at 6
months:
 elective IABP: 4.6%
 no planned IABP: 7.4%
 OR 0.61, 95% CI 0.241.62, p=0.32
All-cause mortality at a
median 51 months:
 elective IABP: 27.8%
 no planned IABP:
38.7%
 hazard ratio 0.66, 95%
Procedural complications:
 elective IABP: 1.3%
 no planned IABP:
10.7%
 OR 0.11, 95% CI 0.010.49, p <0.001
CI 0.44-0.98, p=0.039
Patel et al.
(26)
2009-2011
337
Acute anterior MI within 6
hours of pain onset not in
CS.
CRISP-AMI
Initiation of IABP before
primary PCI and
continuation for at least 12
hours (IABP plus PCI) vs.
primary PCI alone.
RCT


anterior STEMI
significant
myocardium at
risk judged by
degree of ST
elevation
Patients randomized to
PCI alone may have had
subsequent insertion of
IABP if there was clinical
deterioration.
The mean infarct size was
not significantly different
between patients in the:
 IABP + PCI group
42.1% (95% CI 38.7%45.6%)
 PCI alone group 37.5%
(95% CI 34.3%-40.8%)
 p=0.06
At 30 days, there were no
significant differences
between the IABP plus PCI
group and the PCI alone
group in:
 major bleeding or
transfusion
 major vascular
complications
By 6 months there was no
significant difference in:
 death
 composite of death,
recurrent MI or
worsening heart failure
n=161 IABP+PCI
n=176 PCI alone
(MCS pre PCI)
IABP Randomized Trials
Trial
Name/Study
Group
Recruitment
Period
Sample
Size
Study Cohort
Intervention
(Timing of Circulatory
Support)
High Risk Criteria
Efficacy
Safety
Thiele et al.
(27,28)
IABPSHOCK II
RCT
2009-2012
600
AMI patients complicated
by cardiogenic shock (with
or without ST elevation).
Primary PCI 95.8%
Immediate CABG 3.5%
No revascularization 3.2 %
AMI patients in CS
expected to have early
revascularization (PCI or
CABG), were randomly
assigned 1:1 to IABP or no
IABP.
IABP group n=301
(13 didn’t have IABP due
to early death)
Control group n=299
(30 eventually had IABP)
Timing of IABP at the
discretion of the operator.


AMI
CS
At 30 days mortality was
similar in the IABP and no
IABP group (39.7% vs.
41.3%, RR with IABP 0.96,
95% CI 0.79-1.17, p=0.69).
There was no significant
difference in mortality
between the 37 patients
(13.4%) in whom IABP was
inserted before and the 240
patients (86.6%) in whom
the balloon pump was
inserted after
revascularization (mortality,
36.4% and 36.8%
respectively; p=0.96).
(MCS pre and post PCI)
At 1 year mortality remained
similar between groups
(52% vs. 51%, RR 1.01,
95% CI 0.86-1.18, p=0.91).
No significant differences
between the IABP group
and no IABP group in rates
of
 stroke (0.7% vs. 1.7%,
p=0.28),
 bleeding (3.3% vs.
4.4%, p=0.51),
 sepsis (15.7% vs.
20.5%, p=0.15), or
 peripheral ischemic
complications
requiring intervention
in the hospital (4.3%
vs. 3.4%, p=0.53).
Impella Registries
Trial
Name/Study
Group
Recruitment
Period
Sjauw et al.
(29)
2004-2007
Sample
Size
144
Intervention
Patients undergoing elective
high-risk PCI.
(Timing of Circulatory
Support)
Prophylactic MCS using
Impella 2.5.
STEMI within 48 hours, CS
or emergent PCI were
excluded.
Europella
Registry
Maini et al. (30)
Study Cohort
2009-2010
175
USpella
Registry
Consecutive patients
undergoing high-risk PCI.
STEMI and CS were
excluded.
(MCS pre PCI)
In all cases, Impella
support was initiated
prophylactically before the
start of PCI.
High Risk Criteria
Efficacy
Safety

Primary efficacy endpoint of
successful deployment,
operation and explantation
achieved in all 144 patients.
Primary safety endpoint of
incidence of MACCE
occurred in 12.4%.





(MCS pre PCI)

Ferreiro et al.
(31)
Single-Center
Registry
Analysis
2006-2008
27
Consecutive patients
undergoing non-emergent
high-risk PCI.
CS was excluded.
last remaining
patent conduit
LMCA lesions
MVD
“low” LV
function (54% of
patients ≤30%)
No device-related deaths.
No cases of device
malfunction.
Primary safety endpoint
was MACE at 30 days,
which occurred in 8% of
patients.
decreased LV
function (mean
LVEF
31%±17%)
complex
coronary
anatomy (mean
SYNTAX score
37±16)
other severe comorbidities
(DM, CKD,
COPD, prior MI)
Impella support was
associated with significant
improvements in systolic
and diastolic blood
pressures (p<0.0001).
Impella was associated with
a significant improvement in
LVEF at discharge
(31%±15% to 36%±14%,
p<0.0001).
No device malfunction was
reported
depressed LV
function
No adverse cardiac events
noted during 30-day followup

Impella Recover LP 2.5

26 patients received an
Impella successfully. 1
patient received IABP
after Impella device
malfunction.
plus
 multivessel
disease or
 unprotected
LMCA disease
PCI or
 last patent
conduit
(MCS pre PCI)
Mortality at 30 days was
5.5%.
Angiographic success in
99% of cases.
Survival was 96%, 91%
and 88% at 30 days, 6
months, and 12 months.


1 in-hospital death due
to intracranial bleeding
3 cases of limb
ischemia but only 1
requiring surgical
intervention
1 case of hemolysis
Lauten et al.
(32)
2005-2010
120
EUROSHOCK
Registry
Retrospective registry of
patients presenting in CS
secondary to AMI
undergoing primary PCI.
Impella 2.5 implanted for
refractory CS
unresponsive to high-dose
inotropes and IABP
support at the time of
primary PCI.


CS
STEMI


primary end-point of
30-day mortality was
64.2% (77/120)
MACCE were reported
in 15% of cases




(MCS pre PCI)
successful
implantation in 99.2%
bleeding at the access
site requiring
transfusion in 24.2%
vascular surgery 4.2%
hemolysis requiring
blood transfusion
7.5%
Impella Feasibility Trials
Trial
Name/Study
Group
Recruitment
Period
Henriques et
al. (33)
2004-2005
Sample
Size
19
Single-Center
Feasibility
Trial
Dixon et al.
(34)
PROTECT I
Prospective
Feasibility
Trial
2006-2007
20
Study Cohort
Consecutive patients
undergoing high-risk PCI.
All had been declined for
surgery.
Consecutive patients
undergoing high-risk PCI.
STEMI and CS patients
were excluded.
Intervention
(Timing of Circulatory
Support)
High-risk PCI with
Impella 2.5 LP.
Maximum LV support was
120 minutes.
(MCS pre PCI)
High risk PCI with Impella
2.5 circulatory support.
(MCS pre PCI)
High Risk Criteria
Efficacy
Safety



LVEF ≤40%
LMCA PCI
last remaining
conduit PCI
multivessel PCI
No specific outcomes data
available. This was a
feasibility study.

LVEF ≤35%
LMCA PCI
last patent
conduit
Primary efficacy end point
of freedom from
hemodynamic compromise
during PCI (defined as a
decrease in mean arterial
pressure below 60 mmHg
for >10 min) was observed
in all patients.
Primary safety end point of
the incidence of MACE at
30 days occurred in 20% of
patients.




1 case of hematoma
requiring blood
transfusion and manual
compression
8/20 patients developed a
hematoma at the femoral
access site.
Engstrom et
al. (35)
2006
20
Prospective
Feasibility
Trial
Patients within 6 hours of
anterior STEMI symptom
onset.
Patients in CS were
excluded.
Impella inserted
immediately post PCI in
10 consecutive patients.
Compared with 10 patients
receiving standard care.

STEMI
Impella left in situ for 72
hours.
Immediate increase in
cardiac output (4.4 ± 0.3
l/min to 4.9 ± 0.5 l/min, n=5,
p=NS) and decrease in
pulmonary capillary wedge
pressure (24.3 ± 2.4 mmHg
to 17.3 ± 0.4 mmHg, n=5,
p<0.05) was observed.
LV function was not
significantly different
between both groups
(p=0.438).
(MCS post PCI)
No signs of adverse effects
on the aortic valve during
Impella support or after
four months of follow-up.
Four patients from the
Impella group experienced
groin bleeding requiring
transfusion compared with
in the control group.
Impella insertion was
successful in all cases.
Median time for placement
was 11 minutes.
Impella Retrospective Analyses
Trial
Name/Study
Group
Recruitment
Period
Iliodromitis et
al. (36)
2006-2009
Retrospective
Analysis
Sample
Size
38
Study Cohort
Consecutive patients with
UA (n=33) or NSTEMI
(n=5) and severe threevessel-disease undergoing
high-risk PCI.
STEMI and CS were
excluded.
Intervention
(Timing of Circulatory
Support)
Prophylactic insertion of
Impella 2.5 prior to highrisk PCI.
(MCS pre PCI)
High Risk Criteria
Efficacy
Safety


30-day mortality was low at
2.86% due to 1 nonprocedure-related death.
13 (34.2%) patients
received blood transfusions.
ACS
MVD
6 patients developed a
femoral hematoma at the
insertion site and 1
pseudoaneurysm.
Alasnag et al.
(37)
2008-2010
60
Consecutive elective highrisk PCI patients.
Prophylactic MCS with
Impella 2.5 during highrisk PCI.

Emergent PCI was excluded
Retrospective
Analysis
No control group for
comparison.
Average duration of
Impella support was 38 ±
15 minutes.
(MCS pre PCI)
Boudoulas et
al. (38)

2008-2010
75
Patients with ACS who
received MCS during highrisk PCI.
Retrospective
Analysis
IABP (n=62) vs. Impella
(n=13)
(MCS timing not
available)





low LVEF (mean
23% ± 15%)
large percentage
of myocardium
at risk
multivessel
intervention
complex target
lesions (mean
SYNTAX score
30 ± 9)
30-day rates of MI, stroke,
TVR and urgent bypass
surgery was 0%.
Six patients suffered
bleeding requiring
transfusion.
30-day mortality was 5%
(n=3).
Five patients had groin
hematomas, which resolved
without additional
intervention.
LV systolic
dysfunction
ACS
CS
No significant difference in
in-hospital (p=0.10) or 1year (p=0.72) mortality
between the two groups.
Placement of the device
across the aortic valve did
not cause valve injury, and
the device did not cause
limb ischemia or
hemolysis.
No statistically significant
difference in vascular
complications between the
Impella and IABP groups
(p=0.27).
No significant difference in
hematocrit between the two
groups at baseline and 24,
48 and 72 hours post
procedure.
Need for transfusion was
similar between the two
groups.
Impella Randomized Trials
Trial
Name/Study
Group
Recruitment
Period
Sample
Size
Study Cohort
Intervention
(Timing of Circulatory
High Risk Criteria
Efficacy
Safety
Support)
Seyfarth et al.
(39)
Not
reported.
26
All patients with AMI
complicated by CS.
ISARSHOCK
Random assignment to
Impella LP 2.5 (n=13) vs.
IABP (n=13) after
revascularization therapy.


AMI
CS
(MCS post PCI)
RCT
The Impella group was
associated with a
significantly greater change
in cardiac index at 30
minutes (Impella ∆CI=0.49
± 0.46 l/min/m2 vs. IABP
∆CI =0.11 ±0.31 l/min/m2,
p=0.02).
Overall 30-day mortality
was 46% in both groups.
O’Neill et al.
(40)
2007-2010
448
Symptomatic patients
undergoing non-emergent
high-risk PCI.
PROTECT II
IABP (n=225) vs. Impella
2.5 (n=223) to provide
hemodynamic support
during high-risk PCI.
RCT
(MCS pre PCI)




unprotected
LMCA
last patent
conduit
LVEF ≤35%
3-vessel disease
+ LVEF ≤30%
30-day MAE was not
statistically different
between groups:


35.1% for Impella 2.5
vs. 40.1% for IABP,
p=0.227 in the ITT
population and
34.3% vs. 42.2%,
p=0.092 in the PP
population.
The Impella 2.5 arm was
associated with a
significantly lower 90-day
MAE rate (40.0% vs. 51.0%,
p=0.023) in the PP analysis.
Time required to implant
the device was longer in the
Impella group (22 ± 9 vs.
14 ± 8, p=0.40).
No device-related technical
failure, major bleeding, or
ischemia observed during
MCS.
Impella patients required
more blood products
(p=0.39) and hemolysis
was significantly higher in
this group as well.


there were no Impella
device failures
change in creatinine
clearance was similar
in both arms at 24
hours after PCI,
despite a higher
volume of contrast
media received by
Impella patients
TandemHeart Retrospective Analyses
Trial
Name/Study
Group
Recruitment
Period
Alli et al. (41)
2004-2009
Sample
Size
54
Retrospective
Analysis
Study Cohort
Consecutive patients
undergoing excessively
high-risk PCI at a single
center.
Intervention
(Timing of Circulatory
Support)
TandemHeart MCS for
high-risk PCI.
High Risk Criteria
Efficacy
Safety

LVEF <30%
(median 20%)
Jeopardy score
>8 (median score
10)
High SYNTAX
score (median
score 33)
Procedural success rate was
97%, whereas 30-day and 6month survival were 90%
and 87%, respectively.
Major vascular
complications occurred in
13% of cases.
Low LVEF
(mean 31% ±
17%)
LMCA PCI
last patent
conduit PCI
PCI on a vessel
supplying >50%
od remaining
viable
myocardium
multi-vessel PCI
CS
Overall death occurred in
12% at 30 days.
All devices initiated
successfully.
Of the 38 patients not in CS,
death occurred in 1 (2.6%),
recurrent ischemia in 3
(8%), and stroke in 0%.
TIMI major bleeding
occurred in 9 of 50 patients
(18%). TIMI minor
bleeding occurred in 10 of
50 patients (20%),
primarily in the
TandemHeart cases.

Mean support time was
123 minutes (range 30 min
to 22 hours).

(MCS pre PCI)
Schwartz et al.
(42)
Retrospective
Analysis
2008-2010
50
High-risk PCI requiring
MCS
TandemHeart (n=32) vs.
Impella (n=13) vs. IABP
(n=5).
Patients at higher risk of
total circulatory collapse
were preferentially treated
with a TandemHeart,
patients at risk of major,
subtotal hemodynamic
compromise were treated
with an Impella, and
patients with lower risk
were treated with an
IABP.
(MCS pre PCI)






One patient had significant
hematoma requiring
transfusion, and one patient
had a pseudoaneurysm
requiring thrombin
injection.
After device removal
systolic BP and EF (+7.4 ±
11%, p=0.0006) increased in
all groups.
Kovacic et al.
(43)
Retrospective
Analysis
2005-2010
68
Patients undergoing highrisk PCI from a single center
database.
Acute STEMI and CS were
excluded.
Tandemheart (n=32) vs.
Impella Recover 2.5
(n=36) implanted “upfront” prior to PCI.

(MCS pre PCI)




complex
coronary
anatomy
low LVEF
(31.0% ± 13.7%)
comorbid
conditions
refusal for
CABG by
surgeon or
patient
LMCA PCI
The 30-day MACE rate
(death, MI, target lesion
revascularization) was 5.8%.
A single episode of LA
perforation occurred during
TandemHeart implantation.
There were no differences
between the IR2.5 and TH
groups with respect to shortor long-term clinical
outcomes.
Vascular access site
complications similar in
both groups. The overall
rate of major vascular
access site complications
was 7% (n=5).
No in-hospital deaths
occurred.
The use of Impella 2.5, as
compared to TandemHeart,
was associated with
reduced overall procedural
times.
TandemHeart Retrospective Analyses
Trial
Name/Study
Group
Recruitment
Period
Thomas et al.
(44)
2007-2009
Sample
Size
37
Study Cohort
Intervention
High Risk Criteria
Efficacy
Safety
Consecutive patients
undergoing high-risk PCI.
(Timing of Circulatory
Support)
Elective TandemHeart
implantation for MCS.


(MCS pre PCI)

PVAD initiation and the
planned cardiac intervention
were technically successful
in all cases.
47% of cases had at least
minor bleeding during
PVAD initiation or
discontinuation or at
femoral access sites.
Retrospective
Analysis


CS
median LVEF
23%
advanced age (73
± 14 years)
LMCA
multivessel PCI
There was 1 death in the
catheterization laboratory in
a patient with a postinfarction ventricular freewall rupture.
Hospital survival rate of
71%.
TIMI major bleeding
occurred in 31 patients
(82%), and 31 patients
(82%) required a blood
transfusion either during or
following the procedure.
There was no relationship
between bleeding or
transfusion and survival to
discharge.
Vranckx et al.
(45)
Retrospective
Analysis
2002-2008
9
Elective and emergent highrisk PCI to unprotected
LMCA in patients declined
for bypass surgery due to
comorbid conditions.
Elective TandemHeart
implantation for MCS.


Median duration on
circulatory assist was 93
minutes (50.4 – 102).

(MCS pre PCI)


unprotected
LMCA PCI
Logistic
EuroScore 13.64
(7.46-29.67)
Syntax score 43
(41-50)
Mayo Clinic
Risk Score 7 (68)
advanced age
median 65 (range
55-71)
Technical and procedural
success of the PCI was
100%.
Median time for
implantation was 27
minutes (24-30).
6-month mortality rate was
11.1%.
Access site complications
occurred in 4/9 patients
(44.4%).
Major leg ischemia
occurred in 2/9 patients
(22.2%).
Rajdev et al.
(46)
Retrospective
Analysis
Aragon et al.
(47)
Retrospective
Analysis
2004-2005
20
Patients undergoing highrisk PCI.
TandemHeart to provide
MCS.



(MCS pre-PCI)
Not
available.
8
Patients undergoing highrisk PCI.
Paper
published
2005.
TandemHeart to provide
MCS.

(MCS pre-PCI)


TandemHeart for high-risk
PTCA in 7 patients.

(MCS timing not
available)

LV dysfunction
multivessel PCI
unprotected
LMCA PCI
Periprocedural and inhospital mortality was 0%.
Time to implantation was
31 ± 9 minutes.
LV dysfunction
(mean LVEF
30% ±9%)
multivessel PCI
unprotected
LMCA
Procedural success rate was
100%.
Only 1 minor vascular
complication.
No groin complications
after removal of device.
declined for
surgical
intervention
death considered
imminent
without
intervention but
no specific
criteria listed

Six patients event- and
symptom-free at 189 ± 130
days post procedure.
TandemHeart Retrospective Analyses
Kar et al. (48)
2003-2005
18
Retrospective
Analysis
Consecutive patients in a
single center series requiring
MCS.


6 patients survived to
discharge
1 died 28 days after
MCS support
discontinued
1 died in-hospital



hemolysis not detected
in any patients during
TandemHeart support
infection and
thromboembolism did
not occur
100% implantation
success rate
TandemHeart Randomized Trial
Trial
Name/Study
Group
Recruitment
Period
Thiele et al.
(49)
2000-2003
Sample
Size
41
Study Cohort
AMI complicated by CS
undergoing emergent PCI.
Intervention
High Risk Criteria
Efficacy
Safety
(Timing of Circulatory
Support)
Patients randomized to
IABP (n=20) or
TandemHeart (n=21).



TandemHeart was
associated with a significant
improvement in cardiac
power compared with IABP
(p<0.001).
Median time to establish
TandemHeart 25.0 minutes
vs. 11.5 minutes for IABP.
RCT
Majority of patients had
PCI. Only one patient in
each group had bypass

CS
AMI
IABP group
LVEF 28.5%
(20.5-30.5)
TandemHeart
LVEF 25.0%
Similar overall mortality
TandemHeart was
associated with
significantly more patients
grafting instead of PCI.
(MCS pre and post PCI)
(20.0-32.8)
between groups
(TandemHeart 43% vs.
IABP 45%, p=0.86).
No 30-day mortality
differences between pre PCI
MCS (TandemHeart 44%
vs. IABP 56%) and post PCI
MCS (TandemHeart 42%
vs. IABP 36%).
(7 vs. 0) developing limb
ischemia (p=0.009).
TandemHeart was
associated with
significantly more patients
requiring transfusion
compared with IABP
(p=0.002).
Key: IABP=intra-aortic balloon pump; MCS=mechanical circulatory support; RCT=randomised controlled trial; EKG=electrocardiogram; STEMI=ST-elevation myocardial infarction;
LBBB=left bundle branch block; LVEF=left ventricular ejection fraction; PTCA=percutaneous transluminal coronary angioplasty; IRA=infarct-related artery; STD=ST-segment deviation;
AMI=acute myocardial infarction; CS=cardiogenic shock; CABG=coronary artery bypass graft; HR=heart rate; OR=odds ratio; CI=confidence interval; CHF=congestive heart failure;
LAD=left anterior descending; LMCA=left main coronary artery; MACCE=major adverse cardiac and cerebrovascular events; UA=unstable angina; DCM=dilated cardiomyopathy;
LVF=left ventricular failure; VA=ventricular arrhythmia; PVD=peripheral vascular disease; BSA=body surface area; MVD=multivessel disease; SVG=saphenous vein graft;
PCWP=pulmonary capillary wedge pressure; PAP=pulmonary artery pressure; NSTEMI=non-ST-elevation myocardial infarction; RR=relative risk; MACE=major adverse cardiac events;
MAE=major adverse events; ITT=intention-to-treat; PP=per protocol; CPR=cardiopulmonary resuscitation; TIMI=Thrombolysis In Myocardial Infarction; PVAD=percutaneous ventricular
assist device.
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Figure 3 Case Vignette 1 Commentary
Intra-aortic balloon counterpulsation facilitated emergency angioplasty for acute unprotected left mainstem coronary artery occlusion
Acute left mainstem occlusion (LMSO) primary percutaneous coronary intervention (PPCI) is associated with an extensive territory of myocardium
at risk and can be complicated by cardiogenic shock (CS) , microvascular no-reflow and ischemic left ventricular (LV) stunning. Intra aortic balloon
pump (IABP) counterpulsation is the only mechanical circulatory support device that improves diastolic coronary perfusion, reduces afterload and
augments mean arterial pressure and is an appropriate adjunct for this particular clinical scenario.
This 40 year-old male with no previous medical history presented following collapse and chest pain. ‘Bystander’ right coronary artery (RCA)
stenosis (Panel A) and acute LMSO (Panel B) were found on coronary angiography. The patient underwent emergency LMS PPCI using a 6F JL4
guiding catheter. Although features of CS were absent at presentation the patient and equipment were prepared for rescue IABP support. In the
meantime, Thrombolysis In Myocardial Infarction (TIMI) 1 flow with 2.0 mm balloon inflation was established (59 minutes from symptom onset),
but was complicated by hypotension and crushing pulmonary edema. An IABP was inserted to support hemodynamics and to maintain coronary
perfusion pressure. A 4.0 x 16 mm drug eluting stent (DES) was implanted and slow restoration of TIMI 2 flow was achieved (Panel C). As CS
developed early in the procedure, rescue IABP support facilitated successful revascularization and allowed ischemic stunning of the LV time to
recover without device related complications. Cardiogenic shock was successfully treated and IABP removed on day three. A staged restudy and
RCA PCI one week later with a 4.5 x 16 mm DES (Panel D and E) was performed. Post-procedural LV ejection fraction (LVEF) was 39% with an LV
end-diastolic pressure (LVEDP) of 16 mmHg. Persistent hypotension precluded ACE inhibition or beta-blocker therapy. Subsequent clinical follow-
up after 5 years post index event revealed progressive breathlessness. Repeat angiography confirmed widely patent stents (Panel F). With
deteriorating LV function (LVEF 19% and LVEDP 38 mmHg), the patient was referred for heart transplantation.
In cases of acute ischemic shock due to stunning, early hemodynamic support with mechanical adjuncts allows transient recovery of myocardial
performance and, perhaps more importantly, gives the operator sufficient time to deploy stents in an optimal fashion. The widespread familiarity,
ease of use, small sheath size, and minimal anticoagulation requirements made IABP the most suitable option at the time.
Figure 4 Case Vignette 2 Commentary
The Impella 2.5 to provide essential hemodynamic support during high-risk multivessel percutaneous coronary intervention
A 62 year-old gentleman with a background of Type II diabetes mellitus and hypercholesterolemia presented in fulminant cardiogenic shock (CS)
and dynamic anterior ST-changes on ECG. Blood pressure was 87/65 mmHg and heart rate 125 beats per minute sinus tachycardia. He had been
home for two weeks following a trip abroad during which time he had suffered an anterior ST-elevation myocardial infarction. During the index
event, he was thrombolysed and subsequent coronary angiography revealed a right dominant system with diffuse calcific 3-vessel coronary artery
disease and a flow-limiting distal left main coronary artery (LMCA) stenosis. The patient had been offered coronary artery bypass graft surgery but
had declined this.
Bedside echocardiography on arrival revealed mild left ventricular (LV) dilatation and a visual ejection fraction (EF) of 15-20%. There was anterior
wall hypokinesis and inferior wall akinesis with preserved contraction basally. A Heart Team discussion concluded the patient would not be a
candidate for bypass grafting in light of the: delayed presentation, ongoing myocardial ischemia, paucity of targets for graft anastomosis and severe
LV systolic dysfunction. As such, he underwent high-risk emergent multivessel percutaneous coronary intervention (PCI). A multi-purpose catheter
was inserted via the right femoral vein to the pulmonary artery (PA). Opening PA pressure was 50/30 mmHg. A wedge pressure was not taken at
the time. An Impella® 2.5 (Abiomed Inc., Danvers, MA, USA) was implanted via the left femoral artery (Red arrow, Plate A). It was felt that an
Impella was more suitable than an intra-aortic balloon pump since baseline LV function was severely depressed and the cardiac rhythm was too
unstable. A 500 ml bolus of intravenous colloid was given to maintain adequate LV filling pressures to optimize Impella function.
PCI was performed via the right femoral artery. The left anterior descending (LAD) artery was subtotally occluded in its mid section by calcified
disease (Plate A). Rotational atherectomy was performed followed by deployment of a 2.5 x 28 mm drug-eluting stent (DES) (Plate B). The left
circumflex (LCx) was subtotally occluded ostially and diffusely diseased downstream (Plate C). The distal, mid and proximal LCx were then stented
with 2.5 x 18 mm DES following serial balloon dilatations (Plate D). Finally, kissing stenting of the LMCA bifurcation disease was performed using a
3 x 33 mm DES to the LAD and 3 x 18 mm to the LCx arteries. (Plate E and F). During the procedure the systemic arterial pressure (Plate G and H:
red=arterial tracing and blue=pulmonary arterial tracing) would intermittently flatline indicating diminished native LV contractile force and virtual
reliance on the Impella device to maintain coronary perfusion and overall cardiac output. A diffusely diseased right coronary artery was left alone
at this stage. Despite a stormy post-procedural course, the patient survived and received a biventricular pacemaker with defibrillator on discharge.