Hemodynamic support in high-risk percutaneous coronary interventions and cardiogenic shock

12 Pages·2012·2.57 MB·English

Review
Hemodynamic support in high-risk
percutaneous coronary interventions
and cardiogenic shock
Over the last 50 years there have been rapid advances in the development of ventricular assist devices in
the cardiac catheterization laboratory. An ideal device is one that is easy to insert, simple to use, provides
effective support, is associated with minimal complications and provides a morbidity and mortality benefit
for the patient. In this article we will review the currently available percutaneous left ventricular assist
devices and the evidence to support their use.
Keywords: cardiogenic shock n high-risk percutaneous coronary intervention Claudia A Martinez,
n Impella® n intra-aortic balloon pump n percutaneous left ventricular assist devices Apurva O Badheka
n TandemHeart®
& William W O’Neill*
University of Miami, Miller School of
Temporary percutaneous left ventricular (LV) brief episodes of myocardial ischemia or hypo- Medicine, Miami, FL, USA
*Author for correspondence:
assist devices (TPLVAD) have been approved tension can set off a life threatening downward
[email protected]
for hemodynamic support in the setting of spiral of decreased cardiac output, coronary
cardiogenic shock (CS) or for high-risk percu- hypoperfusion, heart failure and hemodynamic
taneous coronary interventions (PCI). An collapse. Prophylactic use of hemodynamic sup-
‘ideal’ TPLVAD is a device that can be rapidly port devices is therefore also employed in such
inserted, provides adequate support, is simple cases, to prevent adverse outcomes [6,101].
to use, has few vascular complications and is
easy to remove. TPLVADs can provide valuable Background
time and help stabilize a ‘crashing and burning’ Hemodynamic support using extracorporeal
patient until recovery or prior to undertaking membrane oxygenators has been described
further definitive treatment measures. since the early 1950s [7]. Subsequently, the
CS is a state of end-organ hypoperfusion intra-aortic balloon pump (IABP) was intro-
due to cardiac dysfunction. Suggestive hemo- duced in the early 1960s and has been used
dynamic parameters include persistent hypoten- increasingly since then (Figure 1). This was fol-
sion (systolic blood pressure <80–90 mmHg or lowed by the introduction of cardiopulmonary
mean arterial pressure 30 mmHg lower than support systems in the 1970s, which used large
baseline) with severe reduction in the cardiac femoral cannulas to pump femoral venous
index (CI; <1.8 l/min per m2 without support or blood through an oxygenator and then back
<2.0–2.2 l/min per m2 with support) and ade- into the femoral artery. The high percentage
quate or elevated filling pressures [1]. Although of multiorgan complications, however, lim-
a slight temporal decline in rates of CS has been ited their widespread use. The Hemopump®
observed with the introduction of routine PCI, (Medtronic, Inc., MN, USA) introduced in
CS still complicates approximately 5–8% of the 1980s was the first active forward-flow
ST-elevation myocardial infarction (STEMI) intraventricular pump; however, it failed to
and 2.5% of non-STEMI cases [2]. Patients be readily adopted. The interim period was
developing CS have a very high mortality rate marked by widespread reliance on IABP,
(>50%) during the index hospital ization [3]. which became the workhorse of cardiac sup-
TPLVAD have been used in the setting of CS port along with extracorporeal membrane
to provide temporizing measures. oxygenation (ECMO). Nevertheless, ECMO
High-risk PCI does not have a universal consists of combined cardiac and respiratory
definition. Nevertheless, most studies consider support and is more technically demanding.
high-risk PCI to be interventions in patients ECMO has been associated with a 40% sur-
with moderately depressed cardiac function, or vival benefit when used during CS as a bridge
in the setting of hemodynamic instability or due to transplant or destination therapy [8–11]. The
to the complex nature of the intervention (coro- details of ECMO as a cardiopulmonary adjunct
nary or structural) [4,5]. In such settings, even are outside the scope of this article. part of
10.2217/ICA.11.98 © 2012 Future Medicine Ltd Interv. Cardiol. (2012) 4(1), 125–136 ISSN 1755-5302 125
Review Martinez, Badheka & O’Neill
these devices and the literature supporting their
use. Impella 5 is a larger verison of the Impella
2.5 and provides up to 5 l of cardiac output.
Since it requires a subclavian cutdown and is
mostly implanted by surgeons, its utility in the
catheterization laboratory is limited.
review of evidence supporting
TPLVAd use in Cs
n IABP
The current American College of Cardiology
(ACC)/American Heart Association (AHA)
guidelines on STEMI list IABP therapy as a
Class IB recommendation in the setting of CS
[12]. IABP therapy also received a Class IIA rec-
ommendation in the ACC/AHA guidelines for
Figure 1. Intra-aortic balloon pump. (A) Intra-aortic balloon pump in aorta
and (B) intra-aortic balloon pump controller. patients with non-STEMI and refractory isch-
Reproduced with permission from [106]. emia [13]. The IABP is the most widely used
support device in the USA in patients with acute
In the early 2000s, the TandemHeart® myocardial infarction (MI). In the Benchmark
(Cardiac Assist, Inc., PA, USA) received US registry involving over 22,000 patients, IABP
approval and has since been extensively used use was successful in >97% of patients, with
in the cardiac catheterization laboratory in major complications arising in <3% of the
the hands of experienced operators. More cases [14].
recently the Impella® device (Abiomed, Inc., Various studies, including randomized tri-
MA, USA) has been introduced into the mar- als, have investigated IABP use in MI and CS
ket and has gained rapid acceptance due to its [15–21]. Recent metana lyses have confirmed the
ease of use (Figure 2). The Reitan catheter pump benefits of IABP in patients treated with throm-
(CardioBridge GmbH, Hechingen, Germany) bolysis. However, IABP therapy in adjunct to
is an experimental intra-aortic axial pump that primary PCI did not demonstrate any benefits
can provide flow rates of up to 20 l/min but is regarding 30-day mortality or changes in LV
not yet commercially available in the USA [102]. ejection fraction (EF; Figure 5 & 6) [22]. In addi-
At present, there are three TPLVAD commer- tion, IABP use was associated with a significant
cially available in the USA that are frequently 6% increase in 30-day mortality in patients
used in the catheterization laboratory – the treated with PCI with a nonsignificant increase
IABP, TandemHeart and the Impella Recover in stroke and bleeding rates. It is worth noting
LP 2.5 (Figures 3 & 4). Each has its own set of that of the three randomized, controlled trials
advantages and challenges (Tables 1 & 2 & box 1). included in this metana lysis comparing IABP
In this review, we will attempt to summarize to no-IABP therapy during primary PCI for
STEMI, two of them (Ohman et al. and Stone
et al.) excluded patients with CS [17,18].The
Catheter diameter third study by Van’t Hof et al. included patients
with CS. However, patients with STEMI and
Flow rate >2.5 l/min signs of CS who were assigned to standard
treatment, crossover to IABP was prespeci-
fied by Van’t Hof [19]. In essence, all patients
12-Fr Blood inlet with CS were switched to IABP support. An
pump motor area ‘on treatment ana lysis’ was not mentioned and
only results from ‘per protocol ana lysis’ were
shown. This highlights the challenges of carry-
ing out a randomized trial evaluating TPLVAD
Outlet area
support in STEMI patients with CS. In con-
clusion, despite the results depicted in this
metana lysis, there is still not enough evidence
Figure 2. Impella® recover 2.5 device. to qualify or disqualify the beneficial effects of
Reproduced with permission from [107]. IABP during CS.
126 Interv. Cardiol. (2012) 4(1) future science group
Hemodynamic support in high-risk PCI & cardiogenic shock Review
Proximal Post high-risk PCI
LAD stenosis
Impella®
Impella®
Figure 3. High-risk intervention of proximal left anterior descending with Impella®
support. (A) Fluoroscopy of baseline coronary anatomy with Impella support prior to coronary
intervention. (B) Fluoroscopy post-coronary intervention of left anterior descending artery
stenosis in the same patient with Impella support.
LAD: Left anterior descending artery; PCI: Percu taneous coronary intervention.
n TandemHeart necessary to prevent vascular complications.
In a small randomized trial of patients with Despite the hemodynamic benefits observed
STEMI and CS, Thiele et al. showed up to 4 l with TandemHeart, the clinical data available
of assisted cardiac support and improvement to support its use in CS remains limited.
in CI and LV filling pressures with the use of
TandemHeart [23]. Subsequent reports showed n Impella
superior hemodynamic support when using The ISAR-SHOCK study randomized
TandemHeart versus IABP without an observ- 26 patients with STEMI and CS to Impella
able impact on 30-day mort ality (Figure 7) [23,24]. 2.5 or IABP (Figures 8 & 9) [25]. The CI increased
Unfortunately, these hemodynamic benefits by 0.49 ± 0.46 l/min in the Impella group
were accompanied by an increase in vascular compared with 0.11 ± 0.31 l/min in the IABP
complications, including access site bleeding group at 30 min (p = 0.02). However, there
and limb ischemia due to the large size can- was no difference in 30-day mortality (46% in
nulas. Appropriate selection of patients with both groups). Lam et al. also showed improved
vascular access to accommodate this device is microvascular indices in anterior STEMI
TandemHeart® cannula
in left atrium
TandemHeart® cannula
in left atrium
Figure 4. Fluoroscopy of high-risk coronary artery disease with TandemHeart® support in a patient with severe
ischemic cardiomyopathy. (A) Angiogram of critical left circumflex disease. Last remaining conduit – prior to intervention with
TandemHeart support. (B) Fluoroscopy post high-risk coronary intervention with TandemHeart support of left circumflex artery
with sequential drug-eluting stent placement.
future science group www.futuremedicine.com 127
Review Martinez, Badheka & O’Neill
Table 1. Characteristics of percutaneous left ventricular support devices.
IABP TandemHeart® Impella® 2.5
Description Over the wire flexible Removes oxygenated blood through a Catheter-based impeller driven axial flow
catheter positioned in trans-septal left atrial cannula and delivers it pump that is inserted retrograde across the
descending aorta through to the aorta via a transfemoral cannula, aortic valve via the femoral artery. Provides
femoral artery access driven by an external microprocessor up to 2.5 l/min of cardiac output. Driven by
controller. Provides up to 5 l/min of blood an electrical motor connected to the inflow
flow. Power is supplied by a direct current, cannula. Connected to a mobile console
electromagnetic motor that operates at that manages the rotational speed and
3000–75,000 rpm. In experienced centers, displays the pressure. Median insertion time
insertion and assembly can take 30 min is <30 min. Approved in Europe for use up
[36,38,43]. Has been used in some patients to 5 days
for up to 14 days
Mechanism Inflation/deflation of Active unloading of the left atrium and Pumps blood from the LV into the
balloon increases arterial, bypassing the left ventricle by diverting ascending aorta. Provides active unloading
diastolic pressure and blood to femoral artery when used as a of the LV and subsequently decreased left
coronary perfusion and LVAD. When used for right ventricular atrial pressure
perfusion to other organ support, active unloading of the right
systems. Decreases heart atrium and bypassing the right ventricle by
rate, LV end diastolic diverting blood to the pulmonary artery
pressure, left atrial pressure
and oxygen consumption
(Figure 10)
Sheath Size 8-Fr sheath, 7.5 Fr when 21-Fr venous transeptal inflow cannula with 12-Fr pump head and 9-Fr catheter that
used sheathless large end holes at the distal tip and 14 side requires a 13-Fr insertion sheath
holes to aspirate oxygenated blood from the
left atrium. Femoral artery sheath 15–17-Fr
cannula or two 12-Fr arterial cannulas for
both femoral arteries
Indications CS, high-risk PCI, structural CS, high-risk PCI, structural procedures CS, high-risk PCI, structural procedures
procedures
Contraindications Peripheral vascular disease, Peripheral vascular disease, previous VSD Peripheral vascular disease, mural thrombus
aortic regurgitation and (hypoxemia due to right-to-left shunt). In in the LV. The presence of a mechanical
coagulopathy due to liver the setting of mechanical resuscitation is aortic valve. Aortic valve disease (relative
or renal dysfunction technically challenging. Severe right heart contraindication). Extreme aorta tortuosity
failure. Coagulopathy due to liver or renal or calcification. Coagulopathy due to liver
dysfunction or renal dysfunction, recent neurological
event or HOCM. Aneurysm or necrotomy
or severe anomaly of the ascending aorta
and/or the aortic arch. VSD after MI.
Anatomic conditions precluding insertion of
the pump. Other illnesses or therapy
requirements precluding use of the pump
Pros Easy to use, rapid insertion Diverts oxygenated blood from the left Simple to use, unloads the LV and delivers
inside or outside of the atrium into the systemic circulation. blood to the ascending aorta. Reduces
catheterization laboratory. Increases cardiac output and blood oxygen consumption and infarct size.
Decreases afterload, pressure. Decreases afterload and preload. Increase cardiac output. Reduction of LV
increases coronary Increases tissue perfusion. Reversal of end-diastolic pressure and volume.
perfusion by augmenting metabolic acidosis. Restores microvascular Maintaining forward flow, LV unloading
diastolic pressure and blood flow. Reduction in infarct size. Rapid and coronary flow independently of
mean arterial pressure. hemodynamic support despite native heart intrinsic cardiac function
Support of choice in the rhythm. Unloads the left ventricle
setting of VSDs
Cons Not an active pump, Bigger vascular profile and higher risk of Bigger vascular profile than IABP and
requires intrinsic LV vascular complications. Complications increased risk of vascular complications.
function. Depends on related to trans-septal puncture Theoretical concern of aortic valve damage
balloon position and ECG
CS: Cardiogenic shock; ECG: Electrocardiogram; HOCM: Hypertrophic obstructive cardiomyopathy; IABP: Intra-aortic balloon pump; LV: Left ventricle; LVAD: Left
ventricular assist device; MI: Myocardial infarction; PCI: Percutaneous coronary intervention; VSD: Ventricular septal defect.
128 Interv. Cardiol. (2012) 4(1) future science group
Hemodynamic support in high-risk PCI & cardiogenic shock Review
patients treated with Impella 2.5 as compared Table 2. overview of complication risks by device profile.
with controls using sublingual side stream dark
Complications IABP TandemHeart® Impella®
field microscopy [26].
Vascular + +++ ++
Safety and feasibility in patients undergo-
ing PCI with anterior STEMI was assessed Nonvascular + +++ ++
in the nonrandomized AMC-MACH study, +: risk of developing complications; IABP: Intra-aortic balloon pump.
which showed a greater decrease in pulmonary
capillary wedge pressure and improvement in More recently, the Academic Medical
LV function in patients who received Impella Center researchers have shown that in patients
support compared with the IABP controls [27]. with STEMI and profound CS, survival was
Longer follow-up from the study showed that improved in patients who received immediate
three-day support with the Impella LP 2.5 Impella 5.0 treatment, as well as in patients who
was not associated with adverse effects on the were upgraded from 2.5 to 5.0 support, com-
aortic valve and lead to significantly improved pared with patients who received only Impella
recovery in the EF [28]. 2.5 [29]. No randomized controlled trial has dem-
In the acute MI cohort of the USPella reg- onstrated superiority between IABP and Impella
istry, the Impella device was used mostly after for long-term outcomes. The ongoing IMPRESS
conventional therapies had failed. It improved in STEMI trial is presently investigating the use
the CI from 1.9 to 2.5 l/min/m2, increased of Impella versus IABP support in large anterior
mean arterial pressure from 62 to 87 mmHg, STEMI being treated with PCI [104].
decreased wedge pressure from 28 to 20 mmHg,
decreased overall systemic vascular resistance review of evidence supporting
and improved EF from 29 to 37%. Of the TPLVAd use in high-risk PCI
patients with acute MI and CS, a total of 58% n IABP
were discharged compared with 89% of MI The IABP is the most widely used support
patients without CS [103]. device for high-risk PCI in the USA [30].
Box 1. Complications related to the use
of percutaneous hemodynamic
support devices.
Vascular
ƒ Limb ischemia
ƒ Laceration
ƒ Major hemorrhage
ƒ Cholesterol embolization
ƒ Compartment syndrome
ƒ Retroperitoneal hematoma
ƒ Arterial or venous thrombosis
ƒ Aortic dissection
Nonvascular
ƒ Cerebrovascular accidents
ƒ Sepsis
ƒ Balloon rupture†
ƒ Thrombocythemia
ƒ Hemolysis
ƒ Peripheral neuropathy
ƒ Thromboembolism
ƒ Hypothermia
ƒ Damage of aortic valve‡
ƒ Potential complications from transeptal
puncture§
Figure 5. Forest plot depicting outcomes including (A) the risk
ƒ Puncture of the aorta, posterior free wall of
differences in 30-day mortality, (B) the mean differences in left
the right atrium, coronary sinus
ventricular ejection fraction, and the risk differences in (C) stroke and
ƒ Dislodgement of the arterial cannula
(d) major bleeding rate.
ƒ Residual left to right shunt
IABP: Intra-aortic balloon counterpulsation; LVEF: Left ventricular ejection
†Applies only to intra-aortic balloon pump. fraction; PCI: Percutaneous coronary intervention.
‡§AApppplliieess oonnllyy ttoo ITmanpdeellma®H.eart®. Reproduced with permission from [22].
future science group www.futuremedicine.com 129
Review Martinez, Badheka & O’Neill
160
e) 140
n
eli
as120
b
%
CI (100
80
0 4 8 12 16
Duration of support (h)
140
e)
n
eli
s
a120
b
%
P (
A100
M
100
* 0 4 8 12 16
CABG Duration of support (h)
* Rescue PCI
80
*p = 0.001
100
e)
n
* eli 90
60 s
* a
b 80
% * %
P ( 60
40 * W
C
* P 50
0 4 8 12 16
Duration of support (h)
20
TandemHeart®
IABP
0
BPBP BPBP BPBP BP BP BPBP BPBP BPBP BP BP Figure 7. Change in hemodynamic
AA AA AA A A AA AA AA A A parameters with TandemHeart® support
INo I INo I INo I I No I INo I INo I INo I I No I as compared with intra-aortic balloon
pump. (A) Change in CI, (B) Change in
Stomel Kovack Bengtson Waksman GUSTO-1 M R MI-2 TT SHreOgiCsKtry Overall MCpuIA:m CPp,a ;(r CdMi)a ACcP hi:na Mdnegexea; niInA a BPrPCte:W rIinaPtl. rpar-easosrutirce ;b alloon
PCWP: Pulmonary capillary wedge pressure.
Figure 6. Metana lysis comparing intra-aortic balloon pump support in Reproduced with permission from [23].
sT-elevation myocardial infarction and cardiogenic shock stratified by
the use of thrombolysis or primary percutaneous coronary intervention.
all cause mortality [31]. However, a trend in
(A) The risk differences in 30-day mortality for the each study, type of reperfusion
the reduction of mortality at 6 months was
therapy and for the overall analysis. The size of each square is proportional to the
weight of the individual study. (B) The percentage of CABG and rescue PCI in the observed for the IABP arm. Another interest-
studies, as well as the weighted overall revascularization, categorized into IABP and ing observation was that operators were unsure
no IABP groups. Single-coloured bars are used if separate figures for percutaneous whether support was required and in which
coronary intervention and coronary artery bypass grafting could not be given.
patient, since half the patients received no sup-
CABG: Coronary artery bypass grafting; IABP: Intra-aortic balloon
port. Importantly, one-fifth of the patients in
counterpulsation; PCI: Percu taneous coronary intervention.
Reproduced with permission from [22]. the ‘watchful waiting’ arm had to ‘crash’ to
end up on IABP support. These patients had a
Recently, the BCIS investigators randomized worse outcome overall. Unfortunately, no pred-
patients with low EF and severe multivessel ictive features for which patients are likely to
disease to control versus prophylactic IABP ‘crash’ exists.
strategy. In this trial, prophylactic IABP use The results of the BCIS trial contradict prior
did not reduce major adverse cardiac and nonrandomized or retrospective data demon-
cerebrovascular event (MACCE) or improve strating decreased MACCE in an elective
130 Interv. Cardiol. (2012) 4(1) future science group
Hemodynamic support in high-risk PCI & cardiogenic shock Review
versus provisional or rescue IABP strategy
[32–34]. In summary, the BCIS trial demon- 0.8
strated that when using prophylactic versus no 2m) Patients with Impella®
planned IABP, there was no significant differ- W/ Patients with IABP
ence in terms of cardiovascular complication x (0.6 *
e
and 6-month mort ality. There was a statisti- nd
cally significant difference in terms of major er i0.4
w
procedural complication in favor of the elec- o
p
tive group, despite a trend towards a higher rate c 0.2
a
of bleeding and vascular complications in the di
r
a
elective group. C
0.0
The recent CRISP-AMI trial addressed
Pre 30 min 2 h 4 h 6 h 14 h 22 h
the use of IABP in patients with anterior wall
Time after implantation
STEMI without CS who were undergoing
PCI [35]. Again there was no reduction in infarct 12
siniz ec l(iansi c sasle sosuedtc boym ceasr dati a6c mMoRnIt)h os.r improvement ol/l) 10 IImABpPella
m
m 8
n TandemHeart ate ( 6
Vranckx et al. have demonstrated the efficacy ct
a 4
of the TandemHeart for providing stable total m l
LV support in the setting of high-risk PCI. ru 2
e
In 23 patients followed over a 6-year period, S 0
TandemHeart insertion required an average 01 6 12 24 48 72
of 35 min for implantation and resulted in Time after implantation (h)
significant reductions in LV filling pressures,
pulmonary capillary wedge pressures and an g/dI)100 * Impella
increase in arterial pressure. However, the m 80 * *
mortality of the cohort was modestly high at bin ( 60 IABP
2ti2o%ns , inw iatlhm voasstc ounlaer- thanirdd bolfe ethdein pga tcioemntps l[i3c6a]-. moglo 40 *
Although the TandemHeart and Impella he 20
devices have not been compared head to head, ree 0
Froesch et al. recently provided some insight F 01 6 12 24 48 72
into this [37]. In a single-center retrospective Time after implantation (h)
experience (n = 75) more TPLVADs were used
in the setting of CS (n = 49) rather than high- Figure 8. Change in (A) cardiac power, (B) serum lactate and
risk PCI (n = 26). TandemHeart was also more (C) hemolysis in patients undergoing Impella® support compared with
intra-aortic balloon pump.
likely to be used for CS. The Impella was more
*p < 0.05 between treatment groups at the specific time points.
likely to be used for high-risk PCI. Mortality
IABP: Intra-aortic balloon pump.
at 6 months was 23% after PCI and 55% after Reproduced with permission from [25].
CS. Complication rates were also as high as
one in three [2]. In a subsequent study, Vranckx n Impella
et al. demonstrated a reduced procedural risk The PROTECT I study was a prospective fea-
and excellent periprocedural circulatory sup- sibility trial that investigated 20 patients with
port using TandemHeart in nine patients for EF of <35% who underwent high-risk PCI of
left main PCI, who were otherwise declined for either unprotected left main artery or of the
CABG [38]. Postprocedure vascular issues were last patent coronary conduit with concomitant
observed in four of these patients. There have Impella support [6]. The device provided hemo-
also been other smaller reports demonstrat- dynamic support and was safe to use. Similar
ing similar procedural success at the expense results were also available in smaller studies
of an increased rate of vascular complications in Europe [44]. The multicenter Europella
[39–42]. Nevertheless, the more recent use of registry involving 144 consecutive patients
suture-mediated femoral artery preclosure may showed that high-risk PCI with Impella sup-
prevent vascular complications when used in port was associated with low (5.5%) mortal-
conjunction with IABP devices [43]. ity with no MIs [45]. Major bleeding was 6%
future science group www.futuremedicine.com 131
Review Martinez, Badheka & O’Neill
were performed in a nonstenotic coronary artery
12 after PCI using adenosine-induced hyperemia
Impella®
at different Impella support levels. LV unload-
10 IABP
n ing by Impella led to increased aortic and intra-
o
cti 8 coronary pressure, hyperemic flow velocity and
n
u coronary flow velocity reserve and decreased
dysfore 6 microvascular resistance. The increased coro-
n c nary flow by Impella support is due to both
as
rg 4 increased perfusion pressure and decreased
o
ulti- 2 intramyocardial resistance from reduced LV
M stretch [47]. The same investigators, using a pres-
sure conductance catheter, also demonstrated
0
dose dependant decrease in end-diastolic wall
Baseline 30 days
stress and improved diastolic compliance by
16 Impella LV unloading [48].
re Impella These encouraging results led to the
u 14
ail IABP PROTECT II trial, which randomized patients
an fnt 12 with high-risk PCI to IABP versus Impella
ge
orm 10 2.5. After an interim ana lysis the trial was
elated assess 8 stthoep fipneda lm reidsuwlatsy fdruoem t o4 f4u7t ipliattyi e[4n9t]s. Hshoowweevde ra,
s-r 6 21% reduction in major adverse events with
psi 4 Impella, compared with the IABP group (40.8
e
S vs 51.4%; p = 0.029). This was driven mainly
2
by a decrease in repeat revascularization. The
0 Impella device provided better stability and
Baseline 30 days
support during PCI allowing the operator to
1.0 perform longer and more complex procedures,
y with more aggressive use of atherectomy [105].
bilit 0.8 Impella An even greater benefit was observed in the
a prespecified subgroup of high-risk PCI with-
b
ro 0.6 out atherectomy subgroup (88% of study),
p
al IABP with the Impella device providing a 29%
v 0.4
vi reduction of major adverse events over IABP.
r
u
S Hospital charges for all PROTECT II patients
0.2
at 90 days were on average US$19,000 lower
with Impella than with IABP use, providing
0.0
0 5 10 15 20 25 30 a further economic stimulus [105]. The use of
Days after randomization Impella in the setting of aortic stenosis and
high-risk PCI has also recently been reported,
Figure 9. Change in organ dysfunction scores (A & B) and survival (B) in especially in the setting of concomitant
patients undergoing Impella® support as compared with intra-aortic valvuloplasty [5,50].
balloon pump.
IABP: Intra-aortic balloon pump.
Conclusion
Reproduced with permission from [25].
Technical advances in coronary intervention
and vascular complications were 4%. These devices have made PCI incredibly predictable
results were also reproduced on the other side and safe. These advances have allowed opera-
of the Atlantic in the high-risk PCI subgroup tors to intervene in complex, high-risk patients
of the USPella registry. Reported overall rate in a way that would not have been conceivable
of MACCE was low at 6% and 30-day survival a decade ago. In order to further expand the
rate was 97% [103]. Real world experiences use- boundaries of PCI, investigators are testing
ing Impella for high-risk PCI have also been the utility of hemodynamic support devices as
very promising [46]. adjunctive therapy for patients at risk of hemo-
Remmelink et al. shed further light on the dynamic collapse during PCI or in the setting
hemodynamic support provided by Impella dur- of CS. Nevertheless, currently, the evidence to
ing high-risk PCI. Intracoronary measurements demonstrate any mortality benefit from the use
132 Interv. Cardiol. (2012) 4(1) future science group
Hemodynamic support in high-risk PCI & cardiogenic shock Review
of current hemodynamic support in the setting
of CS and high risk PCI is not clear. However,
R
the limitations of performing randomized trials Trigger
in this acutely sick group of patients has to be point T Electrocardiogram
P
taken into consideration.
Despite the lack of mortality benefits, the
Q S
devices currently available have been shown to
provide hemodynamic support. However, there Dicrotic notch
is a dearth of truly randomized controlled data
evaluating the use of hemodynamic support
devices and the superiority of one TPLVAD Arterial
over another for long-term mortality in patients pressure
undergoing primary PCI for high-risk MI with
tenuous hemodynamics.
Inflation marker
The recently completed BCIS and
PROTECT II trials have attempted to scien-
tifically study the two most widely available
devices – the IABP and Impella 2.5. These Increased coronary
mmHg
artery perfusion
trials were successful in identifying high-risk
subgroups. One-month mortality was mark- 120
iii
edly higher than standard drug-eluting stent iv
trials. Thus, an EF of <30% with last pat-
vi
ent conduit, unprotected left main or severe
triple-vessel disease can be used as a definition
100
of ‘high-risk PCI’. Trends towards improved
survival exist for IABP in the BCIS trial.
ii
Decreases in major adverse events occurred in
patients not undergoing atherectomy in the
80
PROTECT II trial. These trials will hope- i v
fully encourage further investigations in these Reduced
high-risk patients. myocardial O2
demand
At present, IABPs or Impella are not rou-
tinely indicated for high-risk PCI. However,
because of their ease of use they can provide
rapid support in the setting of CS. The data Figure 10. Hemodynamic changes with intra-aortic balloon pump
support. (A) Unaugmented arterial pressure waveform. (B) Augmented
on TandemHeart are limited but the hemody-
arterial pressure waveform. (i) One complete cardiac cycle; (ii) unassisted aortic
namic benefits in specific clinical scenarios have
end diastolic pressure; (iii) unassisted systolic pessure; (iv) diastolic
to be weighed against the risk of serious vascular augmentation; (v) assisted aortic end diastolic pressure; (vi) reduced systolic
complications. pressure.
Reproduced with permission from [106].
Future perspective
As more complex interventions are being per- Nevertheless, the technological advances
formed on sicker patients and technology con- demand the need for further well-designed
tinues to advance rapidly, the use of TPLVADs randomized studies that can be applied to this
is predicted to increase. The indications will acutely ill population in order to truly define
continue to expand to support more complex the role that TPLVADs will have in the future.
procedures, including structural heart disease
and transcatheter valve therapies, as well as Financial & competing interests disclosure
in the management of cardiomyopathies and WW  O’Neill  has  received  research  support  from 
regenerative cell therapy. We envision that in ABIOMED, Inc. The authors have no other relevant affili-
the near future, percutaneous devices with ations or financial involvement with any organization or 
smaller profiles that are simpler to insert and entity with a financial interest in or financial conflict with 
that still provide effective hemodynamic sup- the subject matter or materials discussed in the manuscript 
port, will continue to be developed in parallel apart from those disclosed. 
to the growth in high-risk procedures in the No writing assistance was utilized in the production of 
cardiac catheterization laboratory. this manuscript.
future science group www.futuremedicine.com 133
Review Martinez, Badheka & O’Neill
executive summary
Indications
ƒ Temporary left ventricular (LV) assist devices are being increasingly used for hemodynamic support in patients with cardiogenic shock and
in those undergoing high-risk percutaneous procedures.
Devices available
ƒ The Intra-aortic balloon pump (IABP), Impella® Recover 2.5 and TandemHeart® are the three commonly used and approved percutaneous
devices in the USA.
Device selection
ƒ There are specific scenarios and indications in which to select one device over the other and the decision can be: selecting or escalating
the support based on the hemodynamic requirements (i.e., IABP→Impella→TandemHeart). This is based on results from small studies
and is not currently supported by data from randomized control trials.
ƒ The IABP continues to be the easiest and fastest support, with the fewest complications compared with the rest.
ƒ During high-risk procedures, the device selected will depend on the operators familiarity and comfort level with each device as well as
with how much support is desired, depending on the patients intrinsic cardiac reserve and nature of planned intervention.
ƒ In the setting of peripheral vascular disease the device with the lowest vascular profile should be initially selected
(IABP→Impella→TandemHeart) in order to avoid vascular complications. Caution should be taken in the cases of Impella and
TandemHeart use.
Caution
ƒ Temporary LV assist devices have not been decisively shown to have mortality benefits and can be associated with increased
complications, depending on their vascular profile. Nevertheless, they do provide crucial hemodynamic support.
ƒ The use of percutaneous LV assist devices should be performed only in centers with trained staff to be able to manage devices during
and after procedure.
Future perspective
ƒ Simple to insert percutaneous devices with smaller vascular profiles, which provide effective hemodynamic support, will continue to be
developed with the growth in high-risk procedures in the cardiac catheterization laboratory.
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