CURRENT STATUS OF
VENTRICULAR ASSIST DEVICES
165
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.
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
Pulsatile flow pumps
(Positive displacement pumps)
Pneumatic
Electromechanical
Centrifugal (radial)
pumps
HeartMate IP
NovaCor
HeartMate II
HeatMate III
Thoratec IVAD
HeartMate VE
Jarvik 2000
Levacor
Medos/HIA-VAD
Arrow LionHeart
DeBakey
VentrAssist
Incor
Heartware HVAD
NEDO Gyro PI-710
DuraHeart
CorAide
166
(a)
(b)
(c)
Fig. A.1 (a)NovaCor-pump unit: top dual pusher plate and magnetic actuator can be recognized 3,
(b) schematic illustration of functional principle of Novacor-System,
(c) Anatomic configuration of the native heart and wearable Novacor LVAD system 4.
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.
excess
4000
had
been
implanted worldwide,
with
Heartmate accounting
of
LVADs
this
number
The
of
the
longest
1,142 days 4.
multi-center
In a
evaluation
of
HeartMate
VE as a bridge to
transplantation,
the
common
adverse
bleeding
31/280
most
Fig. A.2 The HeartMate VE LVAD system 7.
event
was
(11%),
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.
169
(a)
(b)
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
transmission system, namely, by the use of two electromagnetic induction coils
2, 5
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
is just enough for a shower or bath 11. Besides, the controller is also implanted and
can be externally programmed 3.
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.
transmission source, a power pack, a battery charger and portable power supplies.
The total weight of the system is 1.3 kg 11.
170
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
. It can be used to support the left or right ventricle or both. Because the systems are
available in a variety of pump sizes (1080 ml), they are suitable for the entire age
range of pediatric patients including neonates 14. Air is pumped in and out of the first
chamber causing the diaphragm to move up and down, which forces blood in and out
of the second chamber. Polyurethane trileaflet valves are used at the entrance and exit
of the blood chamber in this device 5. The housing is transparent allowing visual
control of filling, emptying, and thrombus formation
13
because device availability is restricted to emergency use, only 25 implants have been
performed 14.
171
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.
Heartmate II: The Heartmate II (Figure A.7) is developed through a collaboration
between Nimbus and the University of Pittsburgh 9. It is an axial flow blood pump
featuring a rotor that spins on two cup-socket ruby bearings
2, 9
. It has percutaneous
(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.
173
Jarvik 2000: The Jarvik 2000 VAD (Figure A.8) is a compact axial flow impeller
pump under development by the Texas Heart Institute.
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
174
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.
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.
175
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
formation
11, 20
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 speeds
176
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.
177
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
440 g
27
total weight of
Levacor is
designed
to
produce an outflow of
6.5
against 100 mm Hg
and
capable of up to 10
L/min
under
such a load.
study
results
have
Animal
been
very
levels
returned
to
to
be
promising, with
L/min
completed.
.Fig. A.12 Levacor left ventricular assist device
hemoglobin
preoperative
levels, and other hematology results were in the normal ranges 28.
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.
2, 27
(Figure A.13). The operating range of the pump is 1,800 to 3,000 revolutions per
minute (rpm) in the normal setting. The impeller is comprised of four small blades
that are embedded with permanent magnets. The impeller blades act as a rotor for the
178
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.
at the apex of the left ventricle. The need for an abdominal dissection and creation of
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.
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.
180
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 hydraulicallylevitated impeller. This mechanism (updown movement and swing motion) is
important for preventing thrombus formation behind the impeller.
References
1. Collard E., Van Dyck M. J., Jacquet L. M., Ventricular assist devices,
Current Opinion in Anaesthesiology, 16:3343, 2003.
2. Timms D. L., Design, Development and Evaluation of Centrifugal Type
Ventricular Assist Devices, PhD thesis, Queensland University of
Technology, Queensland, Australia, 2005.
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71:
S17I-S175., 2001.
11. Siegenthaler, M. P., J. Martin, and F. Beyersdorf, Mechanical Circulatory
Assistance for Acute and Chronic Heart Failure: A Review of Current
Technology and Clinical Practice, Journal of Interventional Cardiology, Vol.
16, No. 6, 2003.
12. http://www.pennstatehershey.org/web/lionheart/
13. Motta P., "Mechanical Support of the Circulation," Book Chapter in
"Anesthesia for Congenital Heart Disease," edited by Andropoulos D., Stayer
S., Russell I., Mossad E., 2nd Ed., pp. 618-643, Wiley Inter-Science, 2008.
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14. Baldwin J. T., Duncan B. W., Ventricular assist devices for children,
Progress in Pediatric Cardiology, 21: 173 184, 2006.
15. Song X, Throckmorton AL, Untaroiu A, Patel S, Allaire PE, Wood HG, Olsen
DB. Axial flow blood pumps. ASAIO J., Jul-Aug; 49(4):355- 364, 2003.
16. Simon MA, Watson J, Baldwin JT, Wagner WR, Borovetz HS., Current and
Future Considerations in the Use of Mechanical Circulatory Support
Devices, Annu. Rev. Biomed. Eng., 10:59-84, 2008.
17. John R., Kamdar F., Liao K., Colvin-Adams M., et al., Cardiogenic Shock:
Diagnosis and Treatment, Ann. Thorac. Surg., Oct., 2008.
18. Hasdai D., Berger B. P., Battler A., Cardiogenic Shock: Diagnosis and
Treatment, Humana Press, 1994.
19. Litmathe J, Boeken U, Feindt P, et al., Mechanical assist devices as bridging
systems to transplantation: A current review, possible risks, and perspectives,
Transplantation Proceedings, 36, 31233128, 2004.
20. Wood H. G., Throckmorton A. L., Untaroiu A., et al., The Medical Physics of
Ventricular Assist Devices, Rep. Prog. Phys., 68: 1-32, 2005.
21. Vedi M. S., Design and Construction of a Left Ventricular Cardiovascular
Assist Device, MSc thesis, Texas A&M University, Aug., 2004.
22. Kiris, C., Kwak, D., and Benkowski, R., Incompressible Navier Stokes
Calculations for the Development of a Ventricular Assist Device, Computers
& Fluids, Vol. 27, Nos 5- 6, pp. 709 - 719, 1998.
23. Wilson W. C., Grande C. M., Hayot D. B., Trauma: Critical Care, Vol. 2,
Informa Healthcare, USA, 2007.
24. Stevenson L. W., Kormos, R. L., Mechanical Cardiac Support 2000: Current
Applications and Future Trial Design, Journal of the American College of
Cardiology, Vol. 37, No. 1, 2001.
25. Friberg B., Friberg S., and Burman L.G., Concept Design and In Vitro
Evaluation of a Novel Dynamic Displacement Ventricular Assist Device,
licentiate thesis in Technology and Health, University of Florida, USA, 2006.
26. H. Hoshi, T. Shinshi, and S. Takatani, Third-generation blood pumps with
mechanical noncontact magnetic bearings, Artificial Organs, 30(5):324338,
2006.
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27. Pagani F. Continuous-flow rotary left ventricular assist devices with "3rd
generation, design. Semin. Thorac. Cardiovasc. Surg., 20: 255-263, 2008.
28. Krishnamani R, DeNofrio D, Konstam MA. Emerging ventricular assist
devices for long-term cardiac support, Nat. Rev. Cardiol., 7(2):71-76, Feb.,
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29. Castillo J. G., Anyanwu A. C., Adams D. H., et al., Real-time 3- dimensional
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30. Nos Y, Furukawa K., Current status of the gyro centrifugal blood pump-development of the permanently implantable centrifugal blood pump as a
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184
project),
Artificial
Organs.
Appendix - B
GEOMETRIC SPECIFICATIONS
OF THE HEARTQUEST - CF4 VAD
(BASELINE BLOOD PUMP OF THE PRESENT STUDY)
185
Appendix - B
STRUCTURE-OF-THE
HEARTQUEST CF4 VAD
The Prototype of the HeartQuest CF4 VAD, which is used as a baseline model in the
present study, consists of five main components: Front housing, Inlet elbow, Rear
housing, Impeller, and stinger head. The detailed drawings of these components are
shown as follows:
186
187
188
189
190
191
192
Appendix - C
VOLUTE CASING
DESIGN PROCEDURE
193
Appendix - C
VOLUTE CASING
DESIGN PROCEDURE
Two techniques are introduced for calculating the geometry of the centrifugal pump
volute. The first assumes the fluid follows the principle of momentum conservation;
the second designs the volute to produce a constant velocity from tongue to throat.
Single, double and circular volute types were designed for its evaluation in VAD
application.
Volute calculations are be based on the concept of constant velocity within the volute
passage. Volute designs are based on the average fluid velocities within the volute
passages. Since these average velocities change with varying pump capacities, the
final volute is designed at the best efficiency point (BEP) and the performance at
conditions either side of the BEP are estimated
The absolute velocity at impeller discharge is an important design parameter in volute
casing design; however the most important parameter is the throat area.
194
The throat velocity (c3) is determined by multiplying this factor by the magnitude of
the actual absolute velocity (c2.) using equation (C.1)
C3 = RC3 . C2
(C. 1)
velocity (c3) is known, it is possible to calculate the area (Av) for any arbitrary angle
() around the volute.
At the volute throat ( = 360 o), the entire rate of flow (Q)
passes, and therefore the area is calculated from Equation (C. 2).
195
Ath = Q / C3
(C. 2)
The base circle diameter is then calculated from Equation (C. 3) as follows:
196
K3 = (Dbc D2) / D2
(C. 3)
To satisfy
continuity,
(C.4)
Where, Av is the volute throat area.
However considerable deviation from this angle is possible with little effect on the
efficiency of low to medium specific speed pumps, since there is only one vane
(volute tongue). Efficiency deterioration is more pronounced with mismatched angles
in centrifugal pumps employing diffuser vanes surrounding the impellers
circumference. This angle matching is more important in pumps of higher specific
speed, even to the extent that the high angle part of the volute tongue may be removed
to improve efficiency.
197
Table C-1 provides a guide to choosing the correct volute width for a given
application.
Table. C.1 Volute Width Guidelines
The volute width should always be larger than that of the impeller outlet. It is also
suggested that the volute width ratio may be reduced to between 1.4 - 1.8, again with
lower numbers corresponding to higher specific speeds.
198
Fig. C.5 Typical Single Volute Profile (Lobanoff and Ross 1985)
Fig. C.6 Universal rectangular double volute pump (Lobanoff and Ross 1985)
199
Diffuser
Upon completion of the volute profile, the throat area must transition to the outlet
cannula. Care was taken to maintain a diffusion angle of less than 13 degrees while
providing a smooth transition to the circular outlet cannula, in order to reduce the
incidence of fluid separation.
200
Appendix - D
PUBLISHED PAPERS
201
202
203