Beruflich Dokumente
Kultur Dokumente
2012
1
Appendix - A
CURRENT STATUS OF
VENTRICULAR ASSIST DEVICES
As new technologies gradually allowed for more efficient heart pumps, several
companies started the development of VADs resulting in various VAD designs, while
many of these VADs are being developed and in various stages of clinical testing.
There are many different criteria of how VADs have been categorized. One obvious
distinction is its system of operation. In the beginning, trials to mimic the heart
function, made VAD designers choose pulsatile displacement pump system.
With the introduction of rotary flow pumps in clinical use, the distinction between
pulsatile and non-pulsatile systems has become important. Rotary continuous flow
blood pumps can be further classified into two categories: centrifugal and axial
pumps. Considering pump design theory, centrifugal pumps are capable of producing
higher pressures at lower flows, while axial flow pumps typically generate higher
flows at lower pressure rises. Axial flow pumps, while they are far more compact
than centrifugal pumps, operate at much higher rotational speeds to produce the
desired pressure rise and flow. Based on this classification, the current commercial
and under development VADs (Table 2) are presented in details as follows.
Table A.1 Overview of well known VADs being developed or available on the market
2
A.1 Pulsatile VAD
Novacor: The Novacor LVAS, shown in Figure A.1, is a unique intracorporeal
partially implantable VAD manufactured by the World Heart Corporation, which is
based in Ottawa 1. The Novacor system makes use of biological valves and a highly
smooth blood contacting sac. Rather than the more common one pusher plate design,
Novacor employs two pusher plates on the front and the back of the flexible smooth
polyurethane sac to push blood out ensuring excellent washout 2. The pusher plates
are coupled to a spring-decoupled pulsed-solenoid energy converter. When an electric
current is supplied to the energy converter, a magnetic field forces the pusher plates to
sandwich the sac, which results in the blood flow into the aorta. After the electric
current has been switched off, two springs force the pusher plates to move away from
the sac, allowing the blood inflow 3.
3
HeartMate IP and VE: The Thoratec Corporation currently produces two models of
HeartMate VADs, the IP and VE devices. The difference between the two HeartMate
devices is that the IP device is pneumatically driven, while the VE device is
electrically driven 5. The VE version of the HeartMate VAD is shown in Figure A.2.
The two HeartMate VAD models are intracorporeal partially implantable devices
commercially available as a bridge to transplantation. Based on the results of the
REMATCH, HeartMate VE VAD was recently approved as a destination therapy 6.
The HeartMate devices have a low speed and high torque motor in combination with a
face cam to drive the pusher-plate type blood pump having a stroke volume of 83 cc.
The flexing diaphragm is made of smooth polyurethane and the pump housing is
made of a titanium alloy. In the inflow and outflow ports, porcine valves are used 4.
4
Fig. A.3 HeartMate XVE design modifications 8.
The major advantages of this Thoratec VAD are its smooth polished titanium pump
housing with a relatively small size and weight (339gm) 9, allowing implantation in
patients ranging from 40 to 100 kg. Only the pump is implanted in a pre-peritoneal
position with a small (9 mm diameter) percutaneous pneumatic drive line for each
VAD connected to a more complex control unit externally, where it can be serviced
and replaced 2.
The Thoratec VAD pump is controlled with a small battery powered pneumatic
unit_10. The valves in the Thoratec VAD are tilting disk valves 5. Figure A.4 is an
illustration of the overall shape of the Thoratec VAD and its specific design features.
The smooth external contours are designed to minimize dead space in the pre-
peritoneal pocket and reduce the risk of infection by taking the advantage of potential
bacteria colonization resistance associated with smooth metallic surfaces.
5
(a) (b)
Fig. A.4 (a) Thoratec VAD positive displacement blood-pump 10,
(b) Cross sectional view of the main design features of the Thoratec VAD
(The cross section follows the axis of the inflow port, passes through the center of the cap
and continues along the axis of the pneumatic line) 10.
Arrow LionHeart: The Arrow LionHeart VAD is a joint project in the development
stages between Arrow International and Pennsylvania State University. This is the
only completely implantable system (Figure 2.5) without a driveline penetrating the
skin having an implanted batteries recharged using transcutaneous energy
2, 5
transmission system, namely, by the use of two electromagnetic induction coils .
Despite lowering the risk of infection, the patient has to continuously wear a battery,
as the support time of the implanted battery only suffices for about 20 minutes, which
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is just enough for a shower or bath . Besides, the controller is also implanted and
3
can be externally programmed .
The pump is based on a roller screw mechanism, which causes linear motion of an
attached circular pusher plate, which compresses the polyurethane blood sac during
systole. In diastole the brushless direct current motor reverses to withdraw the pusher
plate. In addition, Two tilting disc valves are used to maintain the required
unidirectional flow 2. The external electronics are composed of the energy
transmission source, a power pack, a battery charger and portable power supplies.
The total weight of the system is 1.3 kg 11.
6
Fig. A.5 Anatomic configuration of the totally implantable
Arrow LionHeart VAD system 12.
Despite several years of clinical availability, only limited experiences with this device
have been reported 11. The Arrow Lionheart left ventricular assist device is designed
for destination therapy. It was implanted in 23 patients in Europe and in 10 patients
in the United States, from October 2000 till April 2004. It received European
conformity certification on November 7, 2003. Unfortunately, corporate financial
decisions have discontinued the ongoing trials of the Lionheart presently 3.
7
Fig. A.6 Medos HIA ventricle assist device.
Axial VAD
The axial flow rotary blood pump consists of a rotor type impeller which is housed in
a small casing. The displacement volume of these pumps varies from 25 to 64 mL.
The pumps generate high flow at very high pump speeds (8000-25,000 rev/min). The
required impeller peripheral velocity is 2-3 times that of other rotary type devices 2.
8
(b)
(a) (c)
Fig. A.7 (a) Schematic illustration of the implanted HeartMate-II LVAD system 16,
(b) Cross-sectional internal view of HeartMate II left ventricular assist device 17,
(c) HeartMate-II VAD unit: inflow/outflow cannula and percutaneous cable can be recognized 17.
The Heartmate II is currently undergoing Phase II essential trials in the United States
for BTT and DT. The blood-contacting surface of the Heartmate II is a hybrid
between the textured surface of the original Heartmate as well as a smooth titanium
surface to minimize thromboembolization 9.
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Jarvik 2000: The Jarvik 2000 VAD (Figure A.8) is a compact axial flow impeller
pump under development by the Texas Heart Institute. The device can be used as
either an LVAD or RVAD. The rotor represents the only moving part of the device
and is supported at each end by tiny blood-immersed ceramic bearings 2, 9. The rotor
(impeller) consists of a neodymiumironboron permanent magnet and two
hydrodynamic titanium blades on its surface 9. Power is delivered to a brushless DC
motor through an abdominal drive line. The device measures 2.5 cm in diameter, 5.5
cm in length and weighs 85g with a displacement volume of 25 ml. A pediatric model
is under development with an approximate size of 1/5 the original model 2.
A controller determines the fixed rate motor speeds (8,000 12,000 rpm) providing
with a flow up to 7 L/min at a energy consumption of 7 to 8W. The Jarvik 2000
plans to incorporate a rate responsive controller. Detecting rotational speed changes of
the pump with varying loads induced by heart rate changes, the rate-responsive
controller is able to alter the pump speed based on the level of activity. The blood-
contacting surface comprises a smooth mirror finish of titanium 2, 9, 11.
The device received the European conformity certification in 2005 both as bridge to
transplantation and destination therapy. Moreover, it is currently undergoing bridge
to transplantation trials in the United States. The destination therapy version used in
Europe is implanted with the driveline connection on a skull-based pedestal to lower
the incidence of infection, while, has not yet been approved in the USA 2, 9, 11.
10
Debakey LVAD: The DeBakey VAD (Figure A.9) is another compact axial flow
pump developed in a joint work among Baylor College of Medicine, MicroMed
Technology, Inc., and NASA Johnson Space Center 7. The implantable titanium
pump connects the left ventricle apex to the ascending. The pump is driven
electromagnetically and the driving line is guided out percutaneuosly in the region of
the lower abdomen exiting the body near the hip, allowing the external controller to
receive diagnostic information to control the device 2, 19.
Like other axial flow pumps, the DeBakey VAD is compact, measures 7.62 cm in
length, 3.05 cm in diameter and weighs 93g with a displacement volume of 15ml 2.
The pump contains an inducer impeller, actuated by an electromagnet, and is the only
moving part of the system. It is supported at both ends by double pivot bearings. The
bearings of this pump have proven to be extremely reliable in bench mock loop tests,
exceeding 2 years of operability. The inducer impeller has three blades with eight
magnets hermetically sealed in each blade. The impeller rotates at 7,500 to 12,500
rpm with a flow of up to 10 L/min. At 10,000 rpm it requires less than 10 W of
power. Blood flowing through the pump first travels through a flow straightener,
followed by the inducer impeller, and finally through a diffuser before exiting the
device. The diffuser slows the high tangential velocity of the blood as produced in the
impeller region by redirecting it axially, resulting in an increase in the pressure of the
fluid 9, 20.
11
These illustrations shown in figure A.10 represents a visual comparison of the original
ventricular assist device, top, and the unit after modifications by NASA researchers,
center and bottom. Adding an inducer to the MicroMed DeBakey VAD eliminates the
dangerous back flow of blood by increasing pressure and making flow more
continuous 22.
Fig. A.10 NASA MicroMed-DeBakey VAD development using CFD techniques 22.
The DeBakey VAD has been modified from its original design, and recently has
Carmeda CBAS heparin biocompatible coating to the internal pump housing and
internal components that contact the blood to reduce the incidence of thrombus
11, 20
formation . In 2008, the modern version of the device, the HeartAssist 5, is
manufactured by US company MicroMed Cardiovascular. It is considered to be a
fifth generation VAD because it can be implanted adjacent to the heart and has an
exclusive flow probe that provides direct, accurate measurement of blood flow from
the left ventricle to the aorta. The new miniature device is light, easy-to-handle and
can be monitored and controlled externally. The Debakey VAD received the
European conformity certification in 2002 and is currently in US pivotal trials for
bridge to transplantation and destination therapy 9.
Centrifugal VAD
Despite miniaturization, centrifugal flow VADs are somewhat larger and heavier than
axial flow VADs. The rotational speeds of centrifugal flow VADs is much slower
than that of axial flow VADs (about 2,000 4,000 vs. 8,000 25,000 rpm). Higher
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speeds may lead to high shear stresses and thus higher probability of blood damage.
For this reason, centrifugal pumps provide less hemolysis. The same general
advantages and disadvantages apply to centrifugal VADs as to axial flow VADs 23, 24.
Heartmate III:
The HeartMate III, developed by Thoratec, is currently in pre-clinical trials, but
represents a new design approach for centrifugal pumps. Intensive research for a
miniature, low cost pump design resulted in the third generation Heartmate III
concept, a compact centrifugal type blood pump. The size is 1/3rd that of the original
Heartmate I, and is supported by a combination of active and passive magnetic
bearings and is completely enclosed in titanium housing 2. The Heartmate III, as
shown in Figure A.11, is a totally implantable uni-/biventricular assist system.
Contrary to most current centrifugal pumps, the Heartmate III system is designed for
long term use. The used suspension system has established robust and stable rotor
magnetic levitation in all axes with no mechanical bearing, contributing to improve
mechanical durability of the pump 2. Thoratec claim service life of up to 10- 15 years,
making the Heartmate III an ideal candidate for a destination therapy / alternative to
transplant. The pump also contains the same textured surface as the Heartmate XVE
system, and is designed to produce an outflow of 7 L/min against 135 mm Hg with 8
W of power consumption and to be capable of up to 10 L/min under such a load 25, 26.
Moreover, pulsatile pressures are achievable via impeller rotational speed variation 2.
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Levacor VAD: The Levacor VAD (WorldHeart Corporation, Oakland, CA, USA) is
an advanced device designed for long term use. For the improvement of Levacor
VAD durability, a full magnetic suspension of the rotor was established, incorporating
active and passive magnetic bearings to completely levitate the impeller. The
Levacor device uses a compact centrifugal pump with magnetically levitated mixed
flow impeller which is designed to have selectable ranges of speeds to be optimized
for individual patients. The Levacor (Figure A.12) dimensions are 35 in height and
75 mm in diameter, with a total weight of
440 g 27. Levacor is designed to produce
an outflow of 6.5 L/min against 100 mm
Hg and to be capable of up to 10 L/min
under such a load. Animal study results
have been very promising, with over 30
calf studies completed. Plasma-free
hemoglobin levels returned to
preoperative levels, and other hematology Fig. A.12 Levacor left ventricular assist device.
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results were in the normal ranges . (World Heart Corp., Oakland, CA.)
In 2006, the first human implant of the Levacor VAD was performed by a surgical
team at St. Luke's Hospital, Thessaloniki, Greece. The successful implant marked the
start of the feasibility clinical trial for an acute bridge-to-recovery indication. The
patient fully recovered his natural heart function, and the Levacor was explanted after
almost three months support and continues to lead a normal life at home. In 2006, a
second patient has had the same positive experience, which concluded the feasibility
study. On January 2010, the Levacor VAD received the FDA's unconditional
approval for bridge to transplant trial 28.
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switched between three pairs of coils contained within the titanium housing of the
pump 27.
The suspension system is performed passively and is achieved entirely through the
use of eight hydrodynamic bearings, one on each face of the four blades. No magnetic
levitation is utilized in the levitation of the impeller. Dynamic interplay between the
eight hydrodynamic bearing forces, fluid forces and gravitational forces prevents the
spinning impeller from touching any part of the housing of the pump. The absence of
magnetic levitation and monitoring systems to identify impeller position results in a
less complicated electronics and smaller pump design 27, 29.
Clinical trials of the VentrAssist have been completed in Australia and Europe and are
currently being conducted in the United States as part of a FDA-approved pivotal trial
for both bridge to transplant and destination therapy indications. Unfortunately,
further development of the device ceased owing to exhaustion of company funds 27, 28.
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a LVAD pocket is obviated, simplifying the surgical procedure. The impeller is fully
suspended in place by a combination of passive magnetic and hydrodynamic bearing
systems, rotating at 2,000 to 3,000 rpm with a flow of up to 10 L/min 27, 28.
NEDO Gyro PI-710: The Baylor College of Medicine group with the support of a
Grant-in-Aid from the New Energy and Industrial Technology Development
Organization (NEDO) started to develop the "Gyro" permanently implantable
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centrifugal pump as a biventricular assist device . A two week lifetime Gyro
pump was initially developed for bypass applications. This was miniaturised to a
polycarbonate model before the current titanium model evolved. The current NEDO
PI-710 VAD system includes a miniaturised titanium Gyro centrifugal pump with
ceramic pivot bearings, a hydraulically-levitated impeller, an rpm-controlled
miniaturized actuator (all-in-one actuator plus controller) (Figure A.15), an
emergency clamp on the left outflow, and an eccentric inlet port (to washout the
pivot) 2, 30.
16
An internal battery, a controller, a transcutaneous energy transfer system (TET), and a
transcutaneous information transfer system (TIT) are also implanted. The emergency
clamp is accommodated on the outflow of the left pump to prevent back-flow in the
case of pump stoppage 30.
Fig. A.15 (a) Schematic illustration of the implanted NEDO Gyro PI-710 VAD system 30,
(b) Internal view demonstrating the main parts of NEDO Gyro PI-710 pump 30.
The overall size of the PI-710 pump, actuator, and controller is 155 mL of
displacement volume and 480 g in weight. The PI-710 pump has a hydraulically-
levitated impeller. This mechanism (updown movement and swing motion) is
important for preventing thrombus formation behind the impeller.
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