Annals of Biomedical Engineering, Vol. 39, No. 9, September 2011 ( 2011) pp.

2313–2328
DOI: 10.1007/s10439-011-0348-8

Biventricular Assist Devices: A Technical Review

SHAUN D. GREGORY,1,2 DANIEL TIMMS,2,3 NICHOLAS GADDUM,2,4 DAVID G. MASON,2,5
and JOHN F. FRASER2,3,6
1
School of Engineering Systems and Medical Device Domain, Institute of Health and Biomedical Innovation, Queensland
University of Technology, GPO Box 2434, Brisbane, QLD 4001, Australia; 2Critical Care Research Group, The Prince Charles
Hospital, Rode Road, Chermside, Brisbane, QLD 4032, Australia; 3BiVACOR Pty Ltd., Brisbane, QLD, Australia; 4Graduate
School of Biomedical Engineering, University of New South Wales, Sydney, NSW, Australia; 5Dept ITEE, University of
Queensland, St Lucia, Brisbane, QLD 4072, Australia; and 6Department of Intensive Care Medicine, The Prince Charles
Hospital, Brisbane, QLD, Australia
(Received 16 May 2011; accepted 28 June 2011; published online 8 July 2011)

Associate Editor Stefan Jockenhoevel oversaw the review of this article.

Abstract—The optimal treatment option for end stage heart Keywords—Ventricular assist device, Rotary blood pump,
failure is transplantation; however, the shortage of donor Pulsatile blood pump, Physiological control, Heart failure.
organs necessitates alternative treatment strategies such as
mechanical circulatory assistance. Ventricular assist devices
(VADs) are employed to support these cases while awaiting
cardiac recovery or transplantation, or in some cases as INTRODUCTION
destination therapy. While left ventricular assist device
(LVAD) therapy alone is effective in many instances, up to With a worldwide shortage of donor hearts, ven-
50% of LVAD recipients demonstrate clinically significant tricular assist devices (VADs) are being used in end
postoperative right ventricular failure and potentially need a stage heart failure patients as a bridge to decision,
biventricular assist device (BiVAD). In these cases, the
BiVAD can effectively support both sides of the failing heart. bridge to transplant, bridge to myocardial recovery, or
This article presents a technical review of BiVADs, both destination therapy.63,80 The VADs can be employed
clinically applied and under development. The BiVADs to provide mechanical circulatory assistance to the
which have been used clinically are predominantly first left (LVAD), right (RVAD), or both sides of the
generation, pulsatile, and paracorporeal systems that are heart (BiVAD). The BiVADs provide simultaneous
bulky and prone to device failure, thrombus formation, and
infection. While they have saved many lives, they generally mechanical circulatory support to the left and right
necessitate a large external pneumatic driver which inhibits ventricles, pumping blood to the systemic and pul-
normal movement and quality of life for many patients. In an monary systems. Unlike a total artificial heart (TAH),
attempt to alleviate these issues, several smaller, implantable which requires the removal of the native heart, a
second and third generation devices that use either immersed BiVAD provides assistance in parallel to the native
mechanical blood bearings or hydrodynamic/magnetic levi-
tation systems to support a rotating impeller are under heart. The implantation of a TAH provides greater
development or in the early stages of clinical use. Although anatomical space for device placement through
these rotary devices may offer a longer term, completely removal of the native ventricles. However, leaving the
implantable option for patients with biventricular failure, native ventricles in place for BiVAD support allows
their control strategies need to be refined to compete with the the ventricles to act as a natural inflow reservoir, and
inherent volume balancing ability of the first generation
devices. The BiVAD systems potentially offer an improved the remaining ventricular contractility assists in bal-
quality of life to patients with total heart failure, and thus a ancing left and right pump flows. Although their
viable alternative to heart transplantation is anticipated with function is limited, the remaining ventricles may pro-
continued development. duce enough cardiac output for patient survival in the
event of device malfunction. Retaining the ventricles in
Address correspondence to Shaun D. Gregory, School of Engi- BiVAD support also maintains the potential for
neering Systems and Medical Device Domain, Institute of Health myocardial recovery and subsequent patient discharge
and Biomedical Innovation, Queensland University of Technology, without the requirement for a donor heart.45 However,
GPO Box 2434, Brisbane, QLD 4001, Australia. Electronic
mail: [email protected], [email protected],
some ventricular function is necessary to avoid
[email protected], [email protected], John_Fraser@health. thrombus formation within the hypostatic ventricles
qld.gov.au during BiVAD support.
2313
0090-6964/11/0900-2313/0  2011 Biomedical Engineering Society
2314 GREGORY et al.

Mechanical circulatory support devices are catego- vast number of first and second generation device
rized as first, second, and third generation pumps, implantations, it is anticipated that they will provide a
which are classified depending on their operational support system that consumes low power with reduced
characteristics.68,74 First generation devices are volume complications.68
displacement pumps which use pneumatics or electro- This article begins by describing the requirement for
magnetically actuated pusher plates to deform a biventricular assistance and the technical challenges
membrane to deliver pulsatile flow. These devices have confronting BiVADs, such as size limitations and
poor durability due to membrane rupture, bearing, and control strategies. The modes of operation and tech-
mechanical valve wear. They require large control nical characteristics, such as device size, weight, and
consoles with limited portability, and have associated power consumption, are then reviewed for clinically
risks of postoperative infection, significant hemolysis, applied devices and several systems which are currently
thrombus formation, and severe postoperative bleed- under development. Devices which have been clinically
ing.70 Second generation devices use rotary centrifugal, applied hold a current CE mark and/or FDA approval
diagonal, or axial impellers that produce continuous for clinical application of mechanical circulatory sup-
outflow, while having few moving, contacting parts. port. These include the Abiomed BVS5000 and
This reduces device wear, while smaller drive consoles AB5000, Thoratec PVAD and IVAD, Berlin Heart
promote increased patient mobility. Though they EXCOR, Medos HIA-VAD, Levitronx CentriMag,
demonstrate marked improvements over first genera- Jarvik 2000, and HeartWare HVAD devices. Two of
tion devices, these rotary pumps are associated with these devices, the HeartWare HVAD and Jarvik 2000,
increased thrombogenicity and acquired platelet dys- were specifically designed for left ventricular assis-
function due to the lack of pulsatile flow and high tance, however, have been implanted as a BiVAD in
shear forces near the bearings and seals.9,32,36 Third humans.16,25 Devices under development which are
generation rotary pumps completely eliminate reviewed in this article do not have the CE mark or
mechanical wear of the pump components through the FDA approval for mechanical circulatory support and
use of contactless impeller drive and suspension sys- include the CorAide/Dexaide, Korean AnyHeart,
tems. Electromagnetic and/or hydrodynamic forces are Gyro, and BiVACOR BV Assist devices. All BiVADs
employed to levitate the impeller within the housing, reviewed in this article are classified according to their
while active electromagnetic forces are employed to generation, surgical placement, and clinical imple-
rotate the impeller. Although clinical experience with mentation (Fig. 1), while their drive mechanism, flow
third generation devices is limited compared with the profile and clinical purpose are compared in Table 1.

FIGURE 1. Flow chart of the three generations of intracorporeal and paracorporeal/extracorporeal BiVADs including those
applied clinically (not shaded) and under development (shaded).
 Biventricular Assist Devices 2315

TABLE 1. BiVAD drive mechanism, flow profile, and clinical purpose for applied and under development
devices.

Device Drive mechanism Flow profile Clinical purpose

Clinically applied
Abiomed BVS5000 PD, FP Pulsatile Short-term support
Abiomed AB5000 PD, FP Pulsatile Short-term support
Thoratec PVAD PD, FV Pulsatile Medium-term support
Thoratec IVAD PD, FV Pulsatile Medium-term support
Berlin Heart EXCOR PD, FV Pulsatile Medium-term support
Medos HIA-VAD PD, FV Pulsatile Short-term support
Levitronix CentriMag ED, CE Continuous Short-term support
Jarvik 2000 ED, AX Continuous Long-term support
Heartware HVAD ED, CE Continuous Long-term support
Under development
CorAide/DexAide ED, CE Continuous Medium-term support
Korean AnyHeart ED, MA Pulsatile Medium-term support
Gyro ED, CE Continuous Long-term support
BiVACOR BV Assist ED, CE Continuous Long-term support

PD pneumatically driven; ED electrically driven; FP filled passively; FV vacuum-assisted filling; AX axial flow pump;
CE centrifugal flow pump; MA mechanically actuated pump. Short-term support indicates bridging to recovery,
transplant, or longer term support. Medium-term support indicates bridging to recovery or transplant. Long-term
support indicates bridging to recovery, transplant, or destination therapy.

REQUIREMENT FOR BIVENTRICULAR incidence of RV failure requiring RVAD support (5%

SUPPORT of 40 patients and 6% of 484 patients, respectively).
Comparisons between these studies may indicate a
As the muscular left ventricle (LV) constitutes the higher degree of RV failure after LVAD implantation
bulk of the myocardial tissue, the majority of ventric- with pulsatile devices compared with continuous flow
ular dysfunction is initially seen in this region. Thus, the pumps, as found in a multi-institutional study by
majority of patients with end stage heart failure treated Slaughter et al. 66 involving 200 patients.66 Perhaps the
with mechanical circulatory support receive left ven- type of VAD and its controller, along with the patient’s
tricular assistance with a LVAD to increase end organ condition and clinical management, is a defining factor
perfusion. However, the incidence of right heart dys- in right ventricular failure post LVAD implantation.
function after LVAD insertion may vary between 10 Yet until a multi-institutional study is completed with
and 50%,12,25,30,53,55 and is considered the most serious various VAD designs and drive mechanisms, the dis-
complication within the LVAD postoperative period.62 crepancy of RVAD requirement remains.
The management of acute right ventricular (RV) failure While the statistics of RV failure are commonly pre-
post LVAD is difficult, and although pharmaceutical sented, it remains uncertain whether the right heart has
treatment strategies including pulmonary vasodilators, failed before LVAD insertion due to congestion in the
inotropic agents, and phosphodiesterase agents may pulmonary system, or post LVAD insertion due to dis-
temporarily improve RV function, these strategies are rupted systolic interaction of the ventricles, or a combi-
generally short-term, expensive, and require prolonged nation of the two.1,62 Regardless, the timing of this
intensive care management. Some patients do regain diagnosis and subsequent intervention is critical, as
adequate RV function to avoid mechanical RV sup- mortality in patients with delayed re-admittance to sur-
port, but equally, there are many who fail to adequately gery for RVAD implantation is up to 90%.31,54 Assisting
respond to these modalities.54 In fact, the requirement the function of both ventricles at an earlier stage improves
for RVAD placement has been reported in 5–50% of survival by reducing the need for re-operation, improving
LVAD supported patients.11,15,34,39,43,53 This discrep- organ perfusion, and allowing patients to leave hospital
ancy in the reported need for biventricular support is more rapidly through potentially reversing multi-organ
remarkable. Potapov et al.53 reported the requirement failure.39 It is for this reason that BiVAD support must be
for biventricular support in 47.9% of patients in a study initiated as early as possible, while close attention must be
of 1025 various VAD implants. Yet, the studies by Lee given following surgery for any associated complications
et al.39 and Kormos et al.,34 both completed solely with such as significant bleeding, thrombus formation, or
the HeartMate II LVAD (Thoratec Corporation, systemic-pulmonary flow imbalance.
Pleasanton, CA, USA), report significantly reduced
2316 GREGORY et al.

CIRCUIT VOLUME/FLOW BALANCING The BVS5000 has two separate 100 mL pumping
and filling bladders, and a 660 mL system extracor-
Native human circulation is auto-regulated through poreal volume.74 Allowable pumping rates are between
a number of closed loop biological control systems. 3 and 140 beats per minute (BPM). Abiomed tri-leaflet
Arterial pressure and ventricular contractility are Angioflex polyurethane valves are placed at the filling
regulated by baroreceptor stimulation and the Frank- and pumping chamber exits to prevent backflow, while
Starling mechanism, respectively, both of which influ- the chamber bladders are made from the same mate-
ence cardiac output.22,69 Auto-regulation of systemic/ rial. Flow stagnation around these valves is a known
pulmonary volumes during uni-ventricular support, cause for thrombus formation within the pump. These
(e.g., LVAD support), may rely heavily on having one thrombi may dislodge and potentially contribute to
functional ventricle’s native control mechanisms. Pul- patient mortality.
satile devices operating in full-to-empty mode have an The pumping chambers are driven by a pulsatile,
ability to balance outflow, and do not require further pneumatic drive console which can operate the LVAD
flow control for circuit volume balancing.68 However, and RVAD separately, or together. This micropro-
the few documented clinical studies of rotary biven- cessor-based drive console optimizes and balances left/
tricular support warn of hemodynamic instabil- right pumping ratios by automatically adjusting the
ity.13,47,48,58,77 All report the importance of continued systolic/diastolic intervals and beat rate based on
controller development to prevent pulmonary edema measurements of the drive line air flow to/from the
and incidence of suction events in the cannulated heart console. The large drive console measures 610 9
chamber. Clearly then, balancing of circuit volumes is 560 9 845 mm, weighs a substantial 81.6 kg, and uses
crucial for any rotary support device, especially rotary a mean power of 280 W. However, a backup battery is
BiVADs. In order to balance flows with two Gyro capable of supporting the device for up to 1 h in case
pumps, Nosé et al.49 incorporated inlet pressure sen- of power failure. While this device has demonstrated
sors in each VAD to regulate flow, like the Frank- reasonable success bridging patients to recovery from
Starling mechanism. However, blood pump control cardiogenic shock with short-term support, portability
systems like these can be limited by the low reliability issues and thrombus incidence present severe limita-
of long-term blood pressure and flow sensors.19 tions should long-term VAD support be required.60

CLINICALLY APPLIED DEVICES Abiomed AB5000

The Abiomed AB5000 (Abiomed Inc., Danvers,
Abiomed BVS5000
MA, USA) (Fig. 3) was approved by the FDA in 2003.
The Abiomed BVS5000 (Abiomed Inc., Danvers, Similar to the BVS5000, it is a first generation, pneu-
MA, USA) (Fig. 2) was approved in 1992 by the USA matically driven, volume displacement pump; however,
Food and Drug Administration (FDA). It is a first its paracorporeal location means that it can be used as
generation, extracorporeal, dual-chambered BiVAD a first choice VAD treatment or as a replacement to the
with simplicity, and low cost as advantages, making it BVS5000 should greater patient mobility be desired. In
one of the most frequently used BiVADs in the world this latter case, the device can connect to the existing
for treatment of acute cardiogenic shock.61 The pump cannulae of the BVS5000, thus eliminating the need for
is clamped to an IV-type pole, located next to the additional surgery. Offering univentricular or biven-
patient’s bed, at a height below the patient’s atrium to tricular assistance for cardiogenic or postcardiotomy
allow for passive filling.23 shock, the small number of pumps implanted to date
have demonstrated safety and reliability.40,84
The pump weighs 300 g when primed and has a
100 mL blood sac. The total extracorporeal system
priming volume is less than 200 mL, which is less than
the BVS5000. The outlet port uniquely exits centrally
from the pump chamber in an attempt to improve flow
dynamics and thus better chamber washout. The drive
system automatically controls the AB5000 pump at a
fixed rate mode, which usually outputs a 70–80 mL
stroke volume. However, this stroke volume is reduced
at high beat rates up to a maximum of 150 BPM,
FIGURE 2. The Abiomed BVS5000 device with pneumatic which results in a maximum output of 6 L min21. The
driveline and inflow and outflow cannulae. drive console is a fully automatic, vacuum-assisted
 Biventricular Assist Devices 2317

FIGURE 4. The Thoratec PVAD with pneumatic driveline

(Courtesy of Thoratec Corporation).
FIGURE 3. The Abiomed AB5000 device with pneumatic
driveline.
front of the abdomen, the size and weight of the
console designed to support both Abiomed blood Thoratec PVAD can pose problems to patient mobility.
pumps. The drive console has dimensions of To ensure balanced flow between the systemic and
584 9 305 9 737 mm and a weight of 43.5 kg (without pulmonary circulations, the PVAD features a full-
the portable cart), and consumes a maximum power of to-empty actuation mode. A Hall-effect switch attached
250 W. Air supply pressures of 420 and 300 mmHg are to the PVAD chamber senses when the pumping
regulated for LVAD and RVAD systole, respectively, chamber is full and sends a signal to the controller
while negative pressures of 2100 mmHg assist filling in which triggers the supply of compressed air to initiate
both pumps. While the AB5000 pump and drive con- systole. The vacuum-assisted pump has a fixed stroke
sole improved portability from the BVS5000, signifi- volume of 65 mL and a variable pulse rate, producing a
cant further development would be required to minimum and maximum pump output of 1.3 and
improve patient mobility. 7.2 L min21, respectively. The drive system can also
operate in a fixed rate mode or synchronized with the
patient’s ECG.74
Thoratec PVAD
Either the 231 kg Thoratec Dual Drive Console
The Thoratec PVAD (Thoratec Corporation, (DDC) (battery life of 40 min) or the much lighter,
Pleasanton, CA, USA) was approved by the FDA for 9.8 kg, Thoratec TLC-II portable driver can be
bridge to transplant in 1995 and postcardiotomy sup- employed to operate the VAD system, potentially
port in 1998. It is a first generation, pneumatically allowing the patient to return home.74 Like most first
actuated, paracorporeal VAD suitable for left, right, or generation devices, valves in the pneumatic driver
biventricular assistance; however, it has also been used generate a significant amount of noise and are a con-
as a total artificial heart.33 stant cause for patient complaint.6
The PVAD, shown in Fig. 4, consists of a rigid
plastic chamber which houses a polyurethane multi-
Thoratec IVAD
polymer (BPS-215 M polyurethane elastomer) pump-
ing sac to provide extensive flex life, strength, and The intracorporeal, pneumatically actuated, pulsa-
thromboresistance. Mechanical valves are also included tile Thoratec IVAD (Thoratec Corporation, Pleasan-
to provide unidirectional flow.14 The total size of the ton, CA, USA) has been approved by the FDA since
device is approximately 125 9 80 9 60 mm, with a 2004 to support the systemic and/or pulmonary
total displacement volume of 318 mL and weight of circulations in a left, right, or biventricular assist
417 g.56 As the device is located external to the body, in configuration.
2318 GREGORY et al.

FIGURE 6. The Berlin Heart EXCOR (Courtesy of Berlin Heart

AG).

pneumatically actuated, paracorporeal, first generation

VAD capable of left, right, or biventricular support.
Adult pumps, available for use only outside the
USA, come in 50, 60, and 80 mL sizes, while pediatric
pumps, which were granted investigational device use
FIGURE 5. The Thoratec IVAD with percutaneous pneumatic status by the FDA in 2008, have smaller volumes at 10,
driveline (Courtesy of Thoratec Corporation).
20, and 35 mL. Inside the transparent polyurethane
housing, a triple-layered polyurethane membrane sep-
arates the air and blood chambers.8 Including the tri-
With dimensions of 120 9 80 9 50 mm, a total leaflet inlet and outlet valves, all blood contacting
displacement volume of 252 mL and a weight of 339 g, surfaces of the EXCOR pump are coated with
the IVAD is sufficiently smaller and lighter than the Carmeda bioactive surface coating. Despite this coat-
extracorporeal PVAD, yet provides the same 65 mL ing, thrombus formation is often seen in the pump’s
stroke volume and maximum VAD output of valves, indicating the pump or valve design has not
7.2 L min21.56 The size of this first generation device been optimized to improve washout.
does, however, limit BiVAD implantation to larger The drive system, Ikus, is a large, 93 kg electro-
patients, with children and small women usually inel- pneumatic drive unit which can produce pulse rates of
igible for biventricular IVAD support. The IVAD, 30–150 BPM, systolic pressures of 60–350 mmHg,
displayed in Fig. 5, incorporates similar internal pump diastolic pressures of 2100 to 0 mmHg, and systolic
materials and mechanical valves to the PVAD, how- duration of 20–70% of the cardiac cycle. The higher
ever, a titanium alloy housing improves external sur- pressure limits of 2100 mmHg and 350 mmHg may be
face biocompatibility. required to overcome the resistance of smaller pediat-
Usually operating in full-to-empty mode, optical ric cannulae at high heart rates.24 A smaller, 9 kg
infrared sensors are employed to detect the end systolic portable drive unit, the EXCOR mobile driving sys-
and diastolic position of the membrane, providing tem, can be used in a biventricular configuration with
adequate systemic/pulmonary flow balancing. A 9 mm up to 5 h of battery life.4 The mobile driving system is
percutaneous pneumatic line with electrical cable for only available for adult pump sizes, thus, the mobility
the sensor connects the IVAD to either of the drivers of the pediatric population is limited with the larger
employed to operate the Thoratec PVAD (DDC or driver. This is of particular importance with the
TLC-II). The implantable design of the IVAD allows EXCOR system as it is used extensively in Europe as a
for improved patient mobility and reduced infection, bridge to transplant device, which may confine pedi-
however, eliminates advantages seen in the PVAD, atric patients to a hospital or specialist center for
such as ease of replacement and direct pump visuali- longer period of time.8
zation to identify malfunctions, such as thrombus
formation within the pump.
Medos HIA-VAD
With transparent pump chamber sizes varying from
Berlin Heart EXCOR
9 to 80 mL, the paracorporeal Medos HIA-VAD
Developed by Berlin Heart (Berlin Heart AG, (MEDOS Medizintechnik, GmbH, Stollberg, Germany)
Berlin, Germany), the EXCOR device (Fig. 6) is a can be used in adult, infant, and pediatric cases.
 Biventricular Assist Devices 2319

FIGURE 7. The Medos HIA-VAD with pneumatic driveline.

Implanted for mechanical circulatory support since FIGURE 8. The Levitronix CentriMag drive console, mag-
1994, this pneumatically actuated, first generation netic motor, and disposable pump head (Courtesy of Levi-
blood pump is capable of assisting the left, right, or both tronix LLC).
sides of the heart at flow rates ranging from 5 to
6 L min21.3 Adult-sized pumps are 60 mL while pedi- Frequently used as a ‘‘bridge to decision’’ device,10
atric versions come in 25 and 10 mL sizes (Fig. 7). To the CentriMag contains a disposable rotor and poly-
account for the extra bronchial circulation on the left carbonate pump housing assembly which is fitted to an
side, the right side pumps have smaller pump mem- external magnetic motor that controls radial rotor
branes to deliver 10% less cardiac output in a fixed rate position and speed (Fig. 8). Each pump head has a
operational mode.82 total priming volume of just 31 mL. Using bearing-less
The drive system is capable of applying systolic motor technology, the impeller is magnetically levi-
pressures of 50–300 mmHg and diastolic pressures of tated and rotated at speeds of 1500–5500 RPM to
21 to 299 mmHg with systolic times of 20–50% and provide maximum pump flow of 9.9 L min21.
pulse rates of 40–180 BPM depending on the pump Pump speed is altered using an interface on the
size.42 The three-leaflet valves in the inflow and outflow 6.6 kg drive console, which is connected to the 1.7 kg
tracts, and the seamless transparent pump casing, are magnetic motor. While the introduction of this third
made of biocompatible polyurethane.81 Similar to generation pump for provision of biventricular support
most first generation devices, flow paths through the is a reasonable step forward, the large drive console
device appear sub-optimal which commonly leads to and actuator severely limits patient mobility. Also,
thrombus formation in the outflow tracts of both the advantages of third generation pumps such as
LVADs and RVADs.28 Meanwhile, the large drive improved device lifetime and durability may not be
system again confines patients to hospital while noticeable for very short-term support.
receiving VAD support, which severely limits their
quality of life.
Jarvik 2000
The Jarvik 2000 device (Jarvik Heart Inc.,
Levitronix CentriMag
New York, USA) (Fig. 9) has been included in a BTT
The Levitronix CentriMag (Levitronix LLC, trial since 2008 for FDA approval, subsequent to CE
Waltham, MA) obtained CE mark approval in 2002 mark approval for the same application in 2005. The
for short-term support of up to 30 days. This device is device is a second generation, axial flow LVAD that
capable of providing short-term support to the left has also been employed to support right ventricular
and/or right side of the heart and as extracorporeal life function in humans.16,31
support, including ECMO.2 The CentriMag is a third With a weight of just 90 g, length of 55 mm,
generation, electrically operated, extracorporeal, and diameter of 25 mm, and total pump displacement of
centrifugal blood pump. Only with the FDA approval 25 mL, the Jarvik 2000 is small enough for BiVAD
for up to 6 h of ventricular support, trials are implantation in almost any patient. This electrically
underway in the U.S. to investigate longer term sup- powered VAD can deliver flow rates of 3–7 L min21
port of up to 30 days.73 against 100 mmHg at 8000–12000 RPM while using
2320 GREGORY et al.

FIGURE 9. The Jarvik 2000 VAD with electrical lead (Cour-

tesy of Jarvik Heart Inc.).
FIGURE 10. The HeartWare HVAD with electrical lead
(Courtesy of HeartWare Inc.).
4–8 W of power.27 The brushless electromagnetic DC
motor inside the sealed pump housing powers the rotor
through electromagnetic fields that cross the blood a 12 V DC supply, or two rechargeable batteries which
flow path. can provide up to 12 h of power.
A power cable passes through the abdominal wall With a device displacement volume of just 50 mL,
and connects to an external controller, while the sys- the HVAD (Fig. 10) is small enough to be implanted in
tem receives power from lithium–ion or lead acid the pericardial cavity.38 This eliminates the need for
batteries.67 RVAD support was achieved with reduced extensive abdominal dissection which is required for
VAD speeds (6000–10000 RPM) to compensate for the placement of larger implantable VADs. Integrated into
lower pulmonary pressures.31 While presenting excep- the device, the smooth titanium inflow cannula (25 mm
tional reliability as an LVAD, the long-term effects as long and 21 mm outer diameter) is inserted through
RVAD have not been published, and there appears to the left ventricular apex for the LVAD and the free
be no plan to modify the LVAD’s design for RV spe- wall of the right ventricle for the RVAD. To prevent
cific support. septal occlusion of the RVAD inflow, spacers are
added between the outer RV free wall and the pump
to reduce cannula insertion length.25 The HVAD-
HeartWare HVAD
myocardial interface is secured with a sewing ring
Originally developed as LVAD and receiving CE which comprises a Dacron polyester suture ring and
mark approval for BTT applications in 2009, the titanium frame that screws onto the inflow cannula.
HeartWare HVAD (HeartWare Inc, Massachusetts, The decreased pulmonary pressures are compensated
USA) has also been used for biventricular support in by banding/restricting the HVAD outflow cannula to a
humans.25,71 smaller diameter, however, little study has been com-
This third generation blood pump weighs 145 g and pleted to characterize the degree of banding which may
is capable of providing up to 10 L min21 of blood flow vary from patient to patient.25,35
with a wide-blade centrifugal impeller that rotates at a The controller estimates flow by the electrical cur-
maximum speed of 4000 RPM.79 A combined/hybrid rent, impeller RPM, and a clinically determined blood
passive magnetic and hydrodynamic thrust bearing viscosity value. Sensor-less suction detection and cyc-
suspend the impeller within the titanium-ceramic lic-controlled speed change (to decrease areas of blood
housing to improve device durability, while device stasis) systems have been incorporated into the con-
reliability is improved with the use of independently troller algorithm to improve support safety.38 For
driven dual motor stators. Each motor stator has a biventricular support, patients are required to carry
separate cable which passes through the 4.2-mm- two controllers and power supplies. Although they
diameter fatigue-resistant percutaneous driveline and could be incorporated into one controller and power
connects to the external controller and power supply. supply, the reduction in size and weight still presents
Power is delivered through either an AC power supply, an advantage over the previous first generation pump
 Biventricular Assist Devices 2321

control units. Meanwhile, manual adjustment of pump operational pump speed range of 2000–3000 RPM.
speed to ensure flow balancing in a biventricular con- Pumping 5 L min21 against 100 mmHg, the CorAide
figuration has been reported, indicating the potential LVAD uses less than 6 W of power at 2850 RPM.18
need for an automatic speed controller developed The DexAide RVAD was developed by modifying the
specifically for biventricular support.41 CorAide device and has a diameter, length, weight, and
device displacement volume of 44 mm, 48 mm, 280 g,
and 69 mL, respectively.51 The implantable centrifugal
DEVICES CURRENTLY UNDER RVAD was developed by reducing the size of each
DEVELOPMENT primary vane, decreasing the number of primary vanes
from seven to five and redesigning the volute. The
CorAide/DexAide DexAide can pump at speeds ranging from 1800 to
3600 RPM to provide over 5 L min21 cardiac output
Developed at the Cleveland Clinic, the CorAide
to the pulmonary circulation. Using only 2.6 W of
(LVAD) and DexAide (RVAD) (Fig. 11) pumps
power while supplying a flow rate of 5.2 L min21 at
(Arrow International, Reading, USA) are third-
2500 RPM, the DexAide has a battery life of over 12 h
generation, implantable, centrifugal VADs which use
on two fully charged batteries.17 Meanwhile, Saeed
hydrodynamic and magnetic forces to passively sup-
et al.59 demonstrated that Zirconium Oxide can replace
port the rotor. Both devices are characterized by their
titanium in RVAD blood journal bearing applications
inverted motor configuration, with each consisting of
to increase motor efficiency with no additional platelet
an impeller mounted on a ‘‘hollow’’ rotor surrounding
activation or biological deposition.
the cylindrical motor stator. The devices, developed for
A 4 mm percutaneous cable connects each VAD to
bridge-to-transplant applications, were designed to be
the controller, which has a fixed speed mode or a
simple, reliable and reduce contact, and wear and
variable speed mode that responds to the patient’s
potential thrombus formation.
physiological demands. When used for biventricular
The CoreAide has a displacement volume of 84 mL,
support, the LVAD is set to an automatic mode, which
pump weight of 293 g, a portable power supply (6 h
adjusts pump speed to obtain a target flow. LVAD
battery life), and controller weight of 1350 g.58 It can
flow pulsatility is also incorporated as a suction
achieve flow rates from 2 to 8 L min21 and has an
detection mechanism.18 Meanwhile, the RVAD uses
fixed flow control with an added observer suction
detection system which compares changes in flow with
speed variation.57 However, if low LVAD flow pulsa-
tility is recorded, the dual pump controller responds by
increasing the RVAD pump speed until either the
LVAD flow pulsatility is restored, or the RVAD con-
troller senses excessive RV unloading.57

Korean AnyHeart
The Korean AnyHeart (BiomedLab Co., Seoul,
Korea), is an electrically driven, pulsatile BiVAD
which is also capable of operating as a total artificial
heart.46 The left and right pumping chambers are each
approximately 100 mL in volume, while the entire
device and connectors require about 500 mL of blood
to prime.52 These pumping chambers reside either side
of a pendulum driver which swings side to side pro-
viding left systolic function during right side filling and
vice versa. A brushless DC motor drives the pendulum
actuator via an epicyclic gear train to reduce motor
shaft speed and increase torque. The shaft and gear
system, which control the pendulum actuator, are
housed within the casing along with the ventricle
FIGURE 11. The DexAide RVAD assembly including the new chambers. How the alternating motion of the pendu-
zirconia stator housing (bottom left) and the previous FEP-
coated titanium stator housing (bottom right). (Reprinted with lum is achieved from this drive has not been defined in
permission from Saeed et al.59).
2322 GREGORY et al.

the literature, and so the nature of the periodic motion power is also supplied transcutaneously.52 The addition
is unclear. of a transcutaneous power supply and reduction of
This implantable or wearable design, with dimen- overall pump size through a single drive mechanism for
sions of approximately 110 9 88 9 66 mm and mass LVAD and RVAD does present some advantage over
of 780 g, can supply a pulse rate of up to 170 BPM previously developed first generation pumps. However,
without compromising pump filling.52 However, the the apparent complex nature of the epicyclic gear train
device size, similar to two Thoratec IVADs, would to drive the rotating pendulum combined with
pose problems with small patients. The maximum mechanical valves, and a flexible compliance window is
ejection fraction and cardiac output of the AnyHeart sure to result in device wear in the short term.
(Fig. 12) is approximately 65% and 9 L min21,
respectively, with a power consumption of 28.8 W.46
Gyro
With 4 L min21 pump flow against 100 mmHg, a total
system efficiency of 8% and power consumption of less Contributions to the development of this second
than 9 W has been reported.44 The ventricle chambers generation device have been made by the Baylor College
are made of smooth, seamless segmented polyurethane of Medicine (Houston, USA), Miwatec (Tokyo, Japan),
encased in a rigid polyurethane chamber, with 26 mm and the New Energy and Industrial Technology Devel-
polymer valves at the inflow and outflow ports.46 The opment Organization (NEDO) (Kawasaki, Japan).
difference between left and right stroke volumes is The Gyro BiVAD (Fig. 13) incorporates two per-
reportedly compensated by a flexible 56 9 90 mm manently implantable centrifugal pumps, the rotating
polyurethane membrane, however, the operation and impellers of which include additional secondary blades
placement of this membrane is unclear in the literature. to accelerate blood flow beneath the impeller and
An automated control system uses motor current reduce potential thrombus formation from blood cir-
waveforms to alter the AnyHeart pumping conditions. culation on the impeller back face. The seal-less tita-
Decreased ventricular filling due to decreased preload nium alloy pump housing encloses the impeller which
results in increased time before the pendulum motion is supported by a double pivot bearing. The double
comes into contact with the blood sac. The control pivot bearing arrangement provides axial limits to the
system recognizes this delay through changes in motor impeller movement within both the RVAD and LVAD
current and adjusts the pump rate to compensate. The pump casings. The female and male pivot bearings are
external monitoring system communicates with the made of aluminum oxide ceramics and ultra-high
device through a transcutaneous infrared system, while molecular weight polyethylene (UHMWPE), respec-
tively. The VAD impellers, with a diameter of 50 mm,
are magnetically driven, and during operation the
magnetic forces approximately balance the induced
axial hydrodynamic forces upon the rotor, allowing the
impeller to float between the pivot bearings. High
device lifetimes of 8 and 10 years for LVAD and
RVAD, respectively, are therefore expected,49,83 how-
ever, blood compatibility of the contacting pivots are
yet to be demonstrated in a clinical setting.

FIGURE 12. The Korean AnyHeart, implanted sub-diaphrag-

matically as a BiVAD. (Reprinted with permission from Park
et al.52). FIGURE 13. The Gyro PI-710 device.
 Biventricular Assist Devices 2323

The magnetic drive actuator includes the pump

controller and locates below the pump within the
housing. The actuator has a brushless DC motor with
coils fixed in a plastic mount surrounding a rotating
disk with permanent magnets. The active magnetics of
the RVAD, however, have an increased clearance
between the impeller and magnetic coupling to reduce
the magnetic force compared with the LVAD. In this
study lies the only design difference between the two
devices, permitting the lower pressure generation in the
RVAD.26 The VAD inlet port is placed off center in an
attempt to circulate the flow around the upper pivot
bearing to decrease the risk of thrombus formation.
Meanwhile, an emergency clamp is included on the
LVAD outflow to prevent backflow in the event of
FIGURE 14. Non-functional fitting prototype of the BiVACOR
pump malfunction. BV Assist (Courtesy of BiVACOR Pty. Ltd.).
The Gyro pump has a priming volume of 20 mL
and, combined with the housed motor, a weight of
allowing suspension and rotation of the impeller
305 g, height of 53 mm, and diameter of 65 mm.49 The
hub.20,37 The interaction between the magnetic bearing
overall system, including the pump and actuator, has a
and motor system can alter the axial position of the
displacement volume and weight of 155 mL and 480 g,
hub and therefore the respective clearance above the
respectively. While representing a significant reduction
RVAD and LVAD semi-open impeller blades. These
in size compared with first generation pumps, the
actively controlled and coupled impeller clearances
Gyro’s displacement volume is nearly double that of
result in diverging hydraulic efficiency control, mean-
the CorAide device. Therefore, intracorporeal biven-
ing that an increase in the hydraulic output of the
tricular support with the Gyro system may be prob-
LVAD can be created while decreasing that of the
lematic in small patients. The LVAD is capable of
RVAD.72
pumping 5 L min21 against 120 mmHg, while the
Both speed changes and axial clearance adjustment
RVAD can pump the same flow against 40 mmHg.
allow mutually increased and divergent fluid outputs,
Left–right flow control was reported to be achieved
respectively, of the left and right pumps, making this
with a Starling-like regulation, which increases flow
device adequately suited to control systemic and pul-
with increased preload, however, no mention was
monary perfusion. The Frank-Starling-like flow bal-
made on how preload will be measured in the long-
ancing controller uses the current within the magnetic
term.49 Meanwhile, a transcutaneous energy transfer
bearing to detect changes in inlet/outlet pressures, and
system has been developed for the Gyro pump, with a
automatically adjust the impeller position accord-
maximum transmission efficiency of 87.3%.50
ingly.78 Flow rates of 5 L min21 are obtainable with
systemic and pulmonary mean arterial pressures of
100 mmHg and 20 mmHg, respectively, at a pump
BiVACOR BV Assist
speed of 2300 RPM and equal axial clearances above
The BiVACOR BV Assist (BiVACOR Pty Ltd., the LVAD and RVAD impeller blades of 0.5 mm.
Brisbane, Australia) is a third generation BiVAD While maintaining rotational speed and arterial pres-
capable of providing complete circulatory support to sures, an impeller axial displacement of ±0.3 mm can
treat end stage heart failure. A non-functional proto- lead to a relative left–right flow differential of
type of the device is shown in Fig. 14. This rotary 1.8 L min21.75 The current prototype has a diameter
device will use two centrifugal type impellers to of 60 mm and a length of 70 mm.76 The rotor is
simultaneously support the left and right ventricles on capable of reaching speeds up to 3750 RPM to deliver
either side of a single rotating hub. This essentially 8 L min21 cardiac output, while a power consumption
forms a double sided, rotary heart pump with one of less than 15 W is used at 2500 RPM. As the LVAD
single moving part. Passive radial stability of the rotor and RVAD impellers are housed on a common rotat-
is managed via a hydrodynamic radial bearing between ing hub, one would expect an overall increased BiVAD
the outer cylindrical face of the rotating hub and the efficiency compared with two separate centrifugal
outer casing. To achieve axial stability, active magnetic pumps. However, the reported high power consump-
bearings and active motor magnet arrays oppose each tion of the initial prototype indicates that further
other on the RVAD and LVAD casings, respectively, development is required to improve device efficiency.
2324 GREGORY et al.

SUMMARY experience providing biventricular support, the Levi-

tronix CentriMag, appears to have resolved the issue
Despite major advances in the management of acute of device wear; however, this extracorporeal device is
and chronic end stage heart failure, the prevalence of only available for short-term support while the patient
heart failure is increasing due to the lack of donor is confined to the hospital bed. Although the Jarvik
organs.5 The requirement for biventricular mechanical 2000 and HeartWare HVAD devices have been
assistance is not only highlighted by the number of implanted many times with success as LVAD, there is
patients who present with end stage biventricular fail- currently only limited experience of biventricular sup-
ure, but also the looming risk of right heart failure port provided by these pumps.36,64
following LVAD implantation. Developed through Systems currently under development include first
either form, biventricular failure is a serious issue generation (Korean AnyHeart), second generation
affecting a substantial demographic of heart disease (Gyro), and third generation (CorAide/DexAide
patients. Unfortunately though, there are limited and BiVACOR BV Assist) devices. The AnyHeart is
options compared with left heart failure treatment. designed to be completely implantable and operate
This article reviewed BiVAD systems which have with a moving actuator mechanism; however, its large
been clinically applied in humans or are currently size limits the potential patient pool. The Gyro and
under development. The technical characteristics for CorAide/DexAide systems require the implantation of
these devices are summarized in Table 2. First gener- two independently controlled centrifugal pumps to
ation, pulsatile devices, including the Abiomed support both ventricles, which may limit implantation
BVS5000 and AB5000, Thoratec PVAD and IVAD, to larger patients. The DexAide pump is still the only
Berlin Heart EXCOR, and Medos HIA-VAD, provide device designed specifically for RVAD support. How-
short- or medium-term solutions to support patients to ever, specific RVAD development may be delayed
transplant, or even myocardial recovery. Significant further as clinicians have started to use modified sec-
progress has been made over the previous decades to ond and third generation LVAD systems with reduced
improve these first generation devices with the devel- speed or clamped RVAD outflow cannulae to reduce
opment of smaller, battery powered drive consoles pressure sufficiently to be suitable for pulmonary
which help to improve the quality of life of end stage support. This reduces the regulatory workload in
heart failure patients. Meanwhile, the Thoratec IVAD providing viable right ventricular support options, as
is the only implantable first generation device aimed at seen with the Jarvik 2000 and HeartWare HVAD
providing medium-term biventricular support for devices.54,71 Modified LVADs are, however, not ideal
chronic heart failure patients. However, the moving as reduced speed or clamped outflow grafts may
and contacting parts of these first generation pumps encourage thrombogenesis around mechanical bear-
promote device wear, and even the use of smaller drive ings or in cannula folds caused by the partial occlu-
consoles still limit patient mobility. The only third sion. Meanwhile, flow balancing issues may arise
generation rotary device which has reasonable clinical

TABLE 2. Reported technical characteristics of clinically applied and under development BiVADs.

Flow range Speed range Power

Device Size (mL/mm) Weight (g) (L min21) (RPM/BPM) consumption (W)

Clinically applied
Abiomed BVS5000 660 mL 1700* £5.0 3–140 BPM 280
Abiomed AB5000 155 9 80 9 60 mm 300 2.0–6.0 0–150 BPM 250
Thoratec PVAD 125 9 80 9 60 mm 417 1.3–7.2 0–110 BPM –
Thoratec IVAD 125 9 80 9 50 mm 339 1.3–7.2 0–110 BPM –
Berlin Heart EXCOR – – 1.5–12.0 30–150 BPM 12/8+
Medos HIA-VAD – – 5–6.3 40–180 BPM –
Levitronix CentriMag Ø100 9 82 mm 1700 £9.9 1500–5500 RPM 120
Jarvik 2000 Ø25 9 50 mm 90 £7.0 6000–12000 RPM 4–8
HeartWare HVAD 50 mL 145 £10.0 1800–4000 RPM 4.5
Under development
CorAide/DexAide 84/69 mL+ 293/280+ 2.0–8.0 1800–3600 RPM 6/2.6+
Korean AnyHeart 110 9 88 9 66 mm 780 0.0–9.0 0–178 BPM 9–29
Gyro Ø65 9 53 mm 305 0.0–5.0 1300–2650 RPM 15
BiVACOR BV Assist Ø60 9 70 mm – 0.0–8.0 £3750 RPM 15

*Indicates the weight of the device including cannulae, – Indicates the information is not available in the literature, +Indicates values for LVAD/
RVAD.
 Biventricular Assist Devices 2325

unless BiVAD specific controllers are developed for devices. A more holistic approach may be needed
dual LVAD application. The BiVACOR BV Assist which incorporates the interaction between the VADs
device accommodates for flow balance issues through as well as their combined interactions with the car-
its axially dynamic, dual impeller hub system that will diovascular system as a complete system.
automatically respond to changes in inlet and outlet The various implantation techniques may also
pressure, although it is still in the early stages of contribute to the long-term success or failure of these
development. devices to infiltrate the clinical market. First genera-
As physiological control is increasingly becoming a tion devices are not implantable and therefore not
research focus for LVAD development, the fine tuning suitable for long-term biventricular support, excluding
of physiologically sensitive BiVAD systems will follow the Thoratec IVAD and Korean AnyHeart which
the availability of the devices themselves. Preload require considerable abdominal dissection for place-
monitoring measures, alongside active control systems, ment. The CentriMag system is also incapable of
may be crucial to provide elevated cardiac output for intracorporeal placement and thus can only be used for
low level exercise and depressed cardiac output during short-term applications. Pericardial placement of the
sleep. This is particularly pertinent for rotary BiVADs HeartWare or Jarvik devices is an undoubted advan-
to prevent pulmonary edema or ventricular suction.57 tage, however, the cost of the combined pumps for
Sensor-less systems using pulsatility as a surrogate for BiVAD support must be considered. The Gyro,
preload will benefit individually actuated pumps such CorAide/DexAide, and BiVACOR devices are cur-
as dual rotary devices, although their safety in biven- rently suitable for sub-diaphragmatic placement,
tricular support scenarios must to be assessed.7,21 however, with continued development of these sys-
Combined pumps such as the AnyHeart and tems, it is possible that pericardially placed versions
BiVACOR may not be able to easily infer preload will become available. Meanwhile, the easily attachable
from pulsatility as the left and right ventricular pul- sewing ring of the HeartWare device79 may be favored
satility will be transmitted to a common actuator/hub, by surgeons, and additional techniques to easily attach
however, suitable force/pressure signals may be the cannulae while reducing the high rates of postop-
extracted from the magnetic bearing to achieve this in erative bleeding should be investigated.65
a sensor-less fashion. Nevertheless, this emphasizes the The continued improvement of the presented
need for long-term pressure measuring options with devices is necessary to achieve the goal of a long-term
which to manage these devices. device capable of supporting critically ill patients as a
Currently, generally accepted options for clinicians destination therapy. Successful development of a reli-
to provide biventricular support beyond 30 days are able, durable BiVAD will ultimately lead to an
limited to the first generation devices. Although the improved patient survival rate and quality of life for
inherent Frank-Starling-like flow balancing full- those suffering from end stage biventricular heart
to-empty mode of these devices allows for simple failure.
physiological control, limitations in patient mobility,
comfort and quality of life exist until a donor heart is
found.57,66 The lack of focus on RVAD development
ACKNOWLEDGMENTS
has probably hindered the clinical progression and the
availability of a third generation, implantable BiVAD. The authors would like to acknowledge the assis-
This is not surprising considering the requirement for tance from the staff of the mentioned biventricular
left ventricular assistance compared with right ven- assist device companies for providing details and
tricular assistance.29,52 Despite this, the development images to be used in this article. Dr. Timms and
of the CorAide/DexAide, Gyro, and BiVACOR Dr. Fraser report being employees of BiVACOR Pty
devices are focusing on RV specific hydraulic and Ltd with equity ownership in the company. No benefits
magnetic design. However, the control of these devices in any form have been or will be received from a
in response to the patients’ physiological demands commercial party related directly or indirectly to the
must be addressed before a long-term solution can be subject of this manuscript.
anticipated. With the exception of dual device, pneu-
matically driven VAD arrangements which allow a
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