Percutaneous left ventricular assist devices in acute

Review
European Heart Journal (2007) 28, 2057–2063
doi:10.1093/eurheartj/ehm191
Percutaneous left ventricular assist devices in acute
myocardial infarction complicated by cardiogenic shock
Holger Thiele1*, Richard W. Smalling2, and Gerhard C. Schuler1
1
¨mpellstr. 39, 04289 Leipzig, Germany
Department of Internal Medicine/Cardiology, University of Leipzig—Heart Center, Stru
and 2Division of Cardiovascular Medicine, Department of Internal Medicine, The Memorial Hermann Heart and Vascular
Institute, University of Texas, Houston, TX, USA
Received 8 November 2006; revised 4 April 2007; accepted 13 April 2007; online publish-ahead-of-print 22 July 2007
KEYWORDS
Shock;
Heart-assist device;
Heart failure;
Haemodynamics;
Myocardial infarction
Cardiogenic shock (CS) remains the most common cause of death in patients with acute myocardial
infarction (AMI). In addition to percutaneous coronary intervention, inotropes, and fluids, intraaortic
balloon pumping (IABP) is most widely used for initial haemodynamic stabilization. However, the
main limitation of IABP is the lack of active circulatory support and the requirement of a certain
level of left ventricular (LV) function. In many patients with severe depression of LV function, haemodynamic support and LV unloading derived from IABP is insufficient to reverse CS. The use of percutaneous LV assist devices (LVAD) with active circulatory support might be beneficial in CS patients not
responding to standard treatment including IABP support. This review reports the current experience
of percutaneous LVAD in CS complicating AMI.
The incidence of cardiogenic shock (CS) in patients with AMI
ranges from 7 to 10% after acute myocardial infarction
(AMI).1,2 Despite aggressive treatment modalities such as
percutaneous coronary interventions (PCI) and use of
intraaortic balloon support, mortality of CS remains unacceptably high (50–70%).1,3,4 Recovery of myocardial performance following successful revascularization of the
infarct related artery may require several days. During this
period many patients succumb to low cardiac output. Therefore, intraaortic balloon pumping (IABP) is the method of
choice for mechanical assistance,5 since IABP can result in
initial haemodynamic stabilization.6–8 Systematic reviews
on the mode of action, physiological response and clinical
studies have been published elsewhere.9,10 The main limitations of IABP include the lack of active cardiac support,
need for accurate synchronization with the cardiac cycle,
and requirement of a certain level of left ventricular (LV)
function. In many patients with severe depression of
cardiac function or persistent tachyarrhythmias, haemodynamic support and LV unloading derived from IABP are
insufficient to reverse CS.11
Therefore, the use of percutaneous LV assist devices
(LVAD) with active circulatory support might be beneficial
in patients with CS not responding to standard treatment,
although this is currently not supported by randomized controlled clinical data (Figure 1). Usually these devices are
* Corresponding author. Tel: þ49 341 8651426/1428; fax: þ49 341
865 1461.
E-mail address: [email protected]
used as a bridge-to-recovery, which may last several
days. In patients with mechanical complications after AMI,
LVAD are used as a bridge-to-surgery, or in patients
without recovery, the surgical implantation of a long-term
LVAD,12,13 or emergent heart transplantation might be
necessary (Figure 1). Therefore, percutaneous LVAD are
usually designed for a maximum use of 14 days.
Currently, there are several different devices and modes
of operation.
Percutaneous cardiopulmonary bypass
After introduction of the first cardiopulmonary bypass (CPB)
system with oxygenation in 1953, further developments led
to percutaneously implantable devices.14 Such systems
consist mainly of a blood pump and an oxygenator; 16–18
French arterial cannulae in the descending aorta and 18
French venous cannula advanced into the right atrium are
used (Figure 2). These cannulae are connected to an external pump and a membrane oxygenator. After pump priming
with normal saline, blood is withdrawn from the right
atrium and pumped through a heat exchanger, membrane
oxygenator, and ultimately returned into the femoral
artery. The pump provides a continuous flow with maintenance of a pulsatile arterial pressure unless the circulation
is completely supported by the CPB device. There are
several drawbacks of CPB such as large cannulae sizes with
subsequent lower limb ischaemic complications, requirement of perfusionists, lack of direct LV unloading, increased
afterload, and a limited support time (usually ,6 h).15
Therefore, percutaneous CBP has mainly been used for
patients with cardiopulmonary collapse in the cath lab.
& The European Society of Cardiology 2007. All rights reserved. For Permissions, please e-mail: [email protected]
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Introduction
2058
H. Thiele et al.
percutaneous approach, .200 patients have been treated
during resuscitation efforts or in acute severe CS.14,16–23
The survival rates of these reports range from 4–64% with
a mean survival rate of approximately 25%. There are only
limited experiences in CS after AMI,24 and for patients
with mechanical complications.25
In summary, the percutaneous CPB system has been lifesaving for a small group of patients with abrupt haemodynamic collapse in the cath lab. Its use is limited by high
associated complications, need of extracorporeal circulation
and a membrane oxygenator with subsequent activation of
cellular elements, and limited support time. The clinical
impact of new, smaller, and portable devices such as the
Lifebridge B2Tw needs to be determined in future trials.26
Axial flow pumps
Figure 1 Possible scheme for selection of patients with cardiogenic shock
complicating acute myocardial infarction for implantation of left ventricular
assist devices (not supported by randomized controlled trials).
Those patients with abrupt closure of a vessel may be supported until the situation is resolved by either PCI or until
transfer in a stable condition to the operating room for
emergency cardiac surgery. Since the introduction of a
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Figure 2 Schematic drawing of the percutaneous cardiopulmonary bypass
assist device. Transfemoral venous and arterial cannulae are inserted percutaneously. Blood is pumped from the right atrium via a pump and an oxygenator to the abdominal aorta (reprinted with permission of Scholz).
These pumps are usually positioned across the aortic valve
to provide active support by transvalvular LV assistance
(Figure 3). In 1988, Wampler et al.27 were the first to
describe an axial, catheter-mounted LVAD inserted by surgical arteriotomy via the femoral artery. The outer diameter
was 21 French and the length 26 cm. The axial flow pump
consisted of a disposable suction cannula with a turbine
driven by an external motor (Figure 4). The pumping
system consisted of an axial flow blood pump, which was
positioned in the aortic arch or the descending aorta, an
inlet cannula, and a drive cable in a polymeric sheath and
a motor. Depending on the aortic pressure, the pump
capacity was up to 3.5 L/min at a speed of 25 000 r.p.m. In
a canine infarct model, the effects of LV unloading were
assessed. Treatment with the HemopumpTM (Medtronic
Inc., Minneapolis, MN, USA) resulted in significant myocardial salvage as compared with reperfusion alone.28 In
addition, it provided superior LV unloading in comparison
to IABP.28 Similar positive results on LV unloading, myocardial perfusion pressure, and serum lactate levels were
obtained in a sheep model.29,30
In a subsequent small pilot study, the 21 French
HemopumpTM was used in 11 patients with CS after AMI.31
Haemodynamic parameters and catecholamine requirements improved significantly during the initial 24 h of
haemodynamic support. Overall mortality in this trial was
64%.31 However, a transfemoral placement of the pump via
the aortic valve was possible in only two thirds of the
patients despite surgical cutdown of the femoral artery. In
another multiinstitutional study including patients with CS,
the insertion rate of this LVAD was 77%; 30-day-mortality
was 68%.32
A smaller 14 French HemopumpTM (Medtronic Inc.) was
devised that could be inserted percutaneously.33 At a
speed of 40 000 r.p.m. the system delivered flow of up to
2.2 L/min. In a multicentre registry of the percutaneous
HemopumpTM during high-risk PCI, the overall mortality
was 12.5% for 32 patients not in CS.34 In addition, despite
the short-term use, there were significant procedure and
device-related vascular access problems (16% limb ischaemia, 25% bleeding complications).34 As a cause of the high
complication rate, the HemopumpTM never received FDA
approval and further development was not pursued.
Recently, new axial flow devices have been developed.
The Impella Recoverw LP 5.0 (Impella CardioSystems
GmbH, Aachen, Germany) axial flow pump is a microaxial
Percutaneous left ventricular assist devices
2059
Table 1 Technical features of currently available percutaneous
left ventricular assist devices for haemodynamic support in the
cath lab
Catheter size
(French)
Cannula size
(French)
Flow (L/min)
Pump speed
(r.p.m.)
Insertion/
placement
Figure 3 Axial flow pump positioned across the aortic valve into the left
ventricle.
Figure 4 Schematic drawing of the 21 French HemopumpTM . The axial pump
is fixed at the distal part of a flexible silicone suction cannula, which is positioned retrogradely across the aortic valve into the left ventricle. The pump
outlet is located in the aortic arch or in the descending aorta (reprinted with
permission of Scholz).
Impella
Recoverw
LP 5.0
Impella
Recoverw
LP 2.5
—
9
9
21 venous
21
12
12–19 arterial
Max. 4.0
Max. 7500
Max. 5.0
Max. 33 000
Max. 2.5
Max. 33 000
Peripheral
(femoral
artery þ left
atrium after
transseptal
puncture)
þ
214 days
Peripheral
surgical
cutdown
(femoral
artery)
Percutaneous
(femoral
artery)
þ
7 days
þ
5 days
þ
PMN
þþ þþ þ
þ
IDE trial
þ þþ
þ
IDE trial
þþ þ
PMN, pre-market notification; IDE, investigational device exception.
þ, anticoagulation necessary; CE-certification present; þ þ þ, high
relative costs in comparison to IABP; þþ þ þþ very high relative costs
in comparison to IABP.
flow pump capable of delivering a continuous flow of up to
5 L/min (Table 1), which is also available as a surgical insertion LVAD.35,36 By use of this device in a sheep infarction
model, oxygen consumption was reduced during ischaemia
and led to infarct size reduction.37 A drawback was the
requirement of femoral artery surgical cutdown.38
However, in comparison to the Hemopump, positioning
across the aortic valve appears to be successful in a higher
proportion of patients as a guidewire can be positioned
across the device tip. Currently, the Impella Recoverw LP
5.0 has been used in approximately 200 cases, is under
investigational use in a FDA approval study, and has received
CE mark for use in Europe.
A smaller device, the Impella Recover LPw 2.5 approved
for 5 day use in Europe, can be inserted percutaneously
and provides continuous flow up to 2.5 L/min (Table 1).
The device is equipped with a pigtail-catheter at the tip
to ensure stable positioning in the LV and to prevent it
from adhering to the myocardium (Figure 3). So far, there
is only limited clinical experience, in particular in stable
patients with high-risk PCI, and it remains unclear if 2.5 L/
min is adequate to reverse CS.39
Limitations of axial support devices are related to the position in the aortic valve. The presence of a mechanical aortic
valve or an aortic stenosis is a contraindication for the
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Anticoagulation
Recommended
duration of
use
CE-certification
FDA
Relative costs in
comparison to
intraaortic
balloon
pumping
Tandem
HeartTM
2060
implantation. Furthermore, these devices might be inefficient in severe aortic regurgitation, and some need surgical
cutdown of the femoral artery. Due to the high rotation
speed of the impeller, these devices might provoke significant haemolysis.38
Left atrial-to-femoral arterial left
ventricular assist devices
blood surface contact area resulting in reduced potential
for haemolysis and thromboemboli. The implantation procedure has been described in detail elsewhere.43 In brief,
after standard transseptal puncture and pre-dilatation of
the fossa ovalis, a venous inflow cannula is inserted into
the left atrium (Figure 5). Afterwards an arterial cannula
(usually 17 French) needs to be inserted into the femoral
artery. Once all air has been removed from the system,
the cannulae are connected to the extracorporeal centrifugal pump by standard tygon tubing. Oxygenated blood is
drawn from the left atrium and returned via the centrifugal
pump and via the arterial cannula in the femoral artery to
the lower abdominal aorta (Figure 5). After a short learning
curve this device can be inserted and LV assist instituted in
,30 min in the cath lab setting. The system is capable of
delivering flow up to 4.0 L/min at 7500 r.p.m. In a feasibility
trial, 18 patients with CS were enrolled.43 With the device,
CS could be reversed efficiently as monitored by haemodynamic and metabolic parameters, and the overall mortality rate was as low as 44%.43 In a subsequent
randomized trial comparing the Tandem HeartTM and IABP
in 41 patients with revascularized AMI complicated by CS,
the device was able to improve the haemodynamic and
metabolic variables more effectively than with IABP
support.44 However, complications like severe bleeding,
limb ischaemia, or fever were encountered more frequently
after LVAD support, whereas the 30-day-mortality was
similar (IABP 45% vs. LVAD 42%, log-rank, P ¼ 0.86).44
Figure 5 Diagram of the percutaneously inserted transseptal and arterial cannulae connected to the Tandem HeartTM centrifugal pump. Right upper corner:
close-up of the transseptal catheter with large end hole and 14 side holes in the left atrium.
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In 1962, this system was first described by the jugular
approach.40 Initially, left atrial-to-femoral arterial LVAD
were used in patients not weanable from CPB after cardiothoracic surgery.41 Subsequently, percutaneous approaches
for patients undergoing high-risk interventions for shortterm use have been reported.42 Due to the lack of a transseptal cannula that can accommodate flow rates necessary
to provide adequate circulatory support, due to risk of
thrombus formation at the impeller, and due to inherent
haemolysis of high-speed centrifugal pumps, this technique
has not achieved widespread popularity. Therefore, new
developments have been made to avoid the inherent risk
of thrombus formation and haemolysis by centrifugal pumps.
The Tandem HeartTM pVAD (Cardiac Assist Technologies,
Inc., Pittsburgh, PA, USA), which is approved for short-term
haemodynamic support (6 h) by the FDA and which is currently marketed in the USA and Europe, is a new generation
low speed centrifugal continuous flow pump with a low
H. Thiele et al.
Percutaneous left ventricular assist devices
Similar results with increased complications without a significant mortality benefit were obtained in a second multicentre trial of the Tandem HeartTM in comparison to IABP
for CS.45 The most important drawback of the left
atrial-to-femoral-arterial bypass support is the need for
large arterial cannulae to achieve the required flow.
Furthermore, currently little is known about the fate of
the transseptal puncture site. However, in recent series,
no relevant left-to-right shunt has been observed by
careful echocardiographic monitoring.43,44,46
An overview of the technical features of currently available LVAD for percutaneous support or those that can be
inserted by peripheral surgical cutdown is shown in Table 1.
Effects of left ventricular unloading
Limitations
As all percutaneous implantable LVAD provide continuous
flow, this also affects the flow in the coronary arteries,
which leads to non-physiological flow. The debate regarding
the effect of non-pulsatile flow on organ function and the
hormonal situation is extensive and remains controversial
and has not been finally determined.58–60
Active circulatory support LVAD have been used so far only
in small trials with limited number of patients enrolled.
Except the two randomized Tandem HeartTM vs. IABP
trials, there are no randomized trials that have proven a
substantial benefit of these devices over standard treatment.44,45 Although the haemodynamic effects of active
support LVAD have been proven in several trials, there is
no trial that had the power to detect differences in mortality. A large clinical trial, supporting the theoretical
advantages of an active LVAD (in particular in patients with
a significant amount of stunned myocardium not responding
to standard treatment) is warranted; however, currently
there is no larger trial on the horizon. In addition, there
are no trials assessing the merits of risks of each LVAD
against the other. Therefore, no conclusion can be drawn
regarding the different risk of embolic complication, haemolysis, inducement of aortic regurgitation, or the dislodgment
risk from the optimal site in the left atrium or LV.
There are new hypotheses that in the development and
maintenance of CS peripheral factors play an important
role besides extensive myocardial necrosis.61 Theoretically,
extracorporeal support and contact with artificial surfaces
of LVAD might further promote the systemic inflammatory
response syndrome with subsequent deterioration to a multiorgan dysfunction syndrome. A second, potentially deleterious effect of extracorporeal circulation, besides the
propagation of systemic inflammatory response, is the activation of complement and the development of coagulation
with subsequent fibrinolysis, which may progress to disseminated intravascular coagulation leading to severe bleeding
complications.62,63
Furthermore, these devices are expensive in comparison
to standard IABP treatment resulting in up to 30-fold
higher costs (Table 1). In view of these limitations, there
are some general contraindications for LVAD in addition to
specific contraindications of the different systems, such as
contraindication to anticoagulation, severe aortic regurgitation, terminal disease with limited life expectancy,
advanced multiorgan dysfunction syndrome, central
nervous system injury, right ventricular failure, severe
bleeding, sepsis, uncontrolled by antibiotics, and severe
peripheral arterial obstructive disease.
Conclusions
LVAD with active circulatory support reverse haemodynamic
and metabolic parameters in CS more effectively than with
standard IABP treatment alone. The use of these newer percutaneous devices is still in its infancy. The easier and safer
deployment of the newly developed devices may increase
their use for patients not responding to PCI, fluids, inotropes, and IABP. Although, from a theoretical point of
view, these active LVAD might be beneficial, it remains to
be proven that these actually alter the high mortality of
CS patients. Furthermore, these devices are associated
with more complications as a result of the highly invasive
procedure and the extracorporeal support in some of these
devices. Therefore, the decision making process on how to
treat CS complicating AMI in addition to standard treatment
requires an integrated stepwise approach, although the
evidence supporting this is very limited. An LVAD might be
considered on the basis of individual risk, success rates
of standard treatment, and potential periprocedural event
rates.
Conflict of interest: none declared.
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Online publish-ahead-of-print 16 March 2007
The heart of coronary arteries
Marco Valgimigli1,2* and Patrizia Malagutti1,2
1
Institute of Cardiology, University of Ferrara, C.rso Giovecca 203, 44100 Ferrara, Italy and 2Cardiovascular Research
Centre, Salvatore Maugeri Foundation, IRCCS Gussago (BS), Italy
* Corresponding author. Tel: þ39 0532 202143; fax: þ39 0532 241885. E-mail address: [email protected]
A 67-year-old man with a medical history notable
for treated type II diabetes, dyslipidaemia and
hypertension, was admitted to the hospital for
repeated episodes of angina with mild effort or at
rest. A coronary angiogram showed lumen stenosis
in the mid-tract of the right coronary artery and
in the first obtuse marginal branch (Panel A). In
the proximal tract of left anterior descending
artery, a severe stenosis (Panel A, arrow) was also
observed, followed by giant heart-shaped coronary
artery aneurysm (CAA) (Panel B, magnified in the
insert). The patient underwent coronary artery
bypass grafting of the three main coronary
vessels. The 1-year follow-up was uneventful.
CAA, defined as a localized dilatation of the coronary artery with a diameter 1.5 times that of
an adjacent coronary segment, has been observed
in 0.2–5.3% of patients undergoing coronary angiography. CAA most often involves the right coronary
artery followed in frequency by the left anterior
descending. Most CAAs are atherosclerotic in
origin, although other aetiologies include congenital aneurysms, Kawasaki syndrome, infectious
arteritis, and coronary trauma, including that related to percutaneous coronary intervention.
The catheter-based treatment of coronary aneurysm through polytetrafluoroethylene-covered stent implantation or core embolization is feasible in selected cases. The safety and efficacy of the percutaneous approach in comparison with conventional surgical
treatment remain to be established.
Downloaded from by guest on October 21, 2014
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