Patients treated by current ventricular assist devices (VADs) suffer from various post implantation complications including gastrointestinal bleeding and arteriovenous malformation. These issues are related to intrinsically mismatch of generated flow by VADs and the physiological flow. In addition, the common primary drawback of available VADs is excessive surgical dissection during implantation, which limits these devices to less morbid patients. We investigated an alternative soft VAD (SVAD) system that generates physiological flow, and designed to be implanted using minimally invasive surgery by leveraging soft materials. A soft VAD (which is an application of intraventricular balloon pump) is developed by utilizing a polyurethane balloon, which generates pulsatile flow by displacing volume within the left ventricle during its inflation and deflation phases. Our results show that the SVAD system generates an average ejection fraction of 50.18 ± 1.52% (n = 6 ± SD) in explanted porcine hearts. Since the SVAD is implanted via the apex of the heart, only a minithoracotomy should be required for implantation. Our results suggest that the SVAD system has the performance characteristics that could potentially make it useful for patients in acute and/or chronic heart failure, thus serving as a bridge-to-transplantation or bridge-to-recovery.

References

References
1.
Roger
,
V. L.
,
2013
, “
Epidemiology of Heart Failure
,”
Circ. Res.
,
113
(
6
), pp.
646
659
.
2.
Agunanne
,
E.
,
Abbas
,
A.
, and
Mukherjee
,
D.
,
2016
, “
Abstract 163: High Burden of Valvulopathy in Heart Failure: A Moving Target
,”
Circ. Cardiovasc. Qual. Outcomes
,
9
(
Suppl 2
), pp.
A163
A163
.https://www.ahajournals.org/doi/10.1161/circoutcomes.9.suppl_2.163
3.
Potapov
,
E. V.
,
Krabatsch
,
T.
,
Ventura
,
H. O.
, and
Hetzer
,
R.
,
2011
, “
Advances in Mechanical Circulatory Support: Year in Review
,”
J. Heart Lung Transplant.
,
30
(
5
), p.
487
493
.
4.
Frazier
,
O.
,
Rose
,
E. A.
,
Macmanus
,
Q.
,
Burton
,
N. A.
,
Lefrak
,
E. A.
,
Poirier
,
V. L.
, and
Dasse
,
K. A.
,
1992
, “
Multicenter Clinical Evaluation of the HeartMate 1000 IP Left Ventricular Assist Device
,”
Ann. Thorac. Surg.
,
53
(
6
), pp.
1080
1090
.
5.
Cheng
,
A.
,
Williamitis
,
C. A.
, and
Slaughter
,
M. S.
,
2014
, “
Comparison of Continuous-Flow and Pulsatile-Flow Left Ventricular Assist Devices: Is There an Advantage to Pulsatility?
,”
Ann. Cardiothoracic Surg.
,
3
(
6
), pp.
573
581
.
6.
Bozkurt
,
S.
,
2016
, “
Physiologic Outcome of Varying Speed Rotary Blood Pump Support Algorithms: A Review Study
,”
Australas. Phys. Eng. Sci. Med.
,
39
(
1
), pp.
13
28
.
7.
Grooters
,
R. K.
,
1992
, “
External Cardiac Assist Device
,” U.S. Patent No. US5131905A.
8.
Snyders
,
R. V.
,
1987
, “
Ventricular Assist Device
,” U.S. Patent No. US4690134A.
9.
Roche
,
E. T.
,
Horvath
,
M. A.
,
Wamala
,
I.
,
Alazmani
,
A.
,
Song
,
S.-E.
,
Whyte
,
W.
,
Machaidze
,
Z.
,
Payne
,
C. J.
,
Weaver
,
J. C.
,
Fishbein
,
G.
,
Kuebler
,
J.
,
Vasilyev
,
N. V.
,
Mooney
,
D. J.
,
Pigula
,
F. A.
, and
Walsh
,
C. J.
,
2017
, “
Soft Robotic Sleeve Supports Heart Function
,”
Sci. Transl. Med.
,
9
(
373
), p. eaaf3925.
10.
Parissis
,
H.
,
Graham
,
V.
,
Lampridis
,
S.
,
Lau
,
M.
,
Hooks
,
G.
, and
Mhandu
,
P. C.
,
2016
, “
IABP: History-Evolution-Pathophysiology-Indications: What we Need to Know
,”
J. Cardiothoracic Surg.
,
11
, p.
122
.
11.
Zhang
,
J.-M.
,
Liu
,
X.-C.
,
Liu
,
Z.-G.
,
Zhao
,
L.
,
Yang
,
L.
,
Liu
,
T.-W.
, and
He
,
G.-W.
,
2015
, “
Comparison of Effects of Extra-Thoracic Paraaortic Counterpulsation to Intraaortic Balloon Pump on Circulatory Support in Acute Heart Failure
,”
J. Cardiothoracic Surg.
,
10
, p.
173
.
12.
Stamatelopoulos
,
S. F.
,
Kochilas
,
L.
,
Saridakis
,
N. S.
,
Zakopoulos
,
N. A.
, and
Moulopoulos
,
S. D.
,
1996
, “
Left Intraventricular Balloon Pump Optimization During Intractable Cardiac Arrest
,”
Int. J. Artif. Organs
,
19
(
7
), pp.
422
430
.https://www.ncbi.nlm.nih.gov/pubmed/8841857
13.
Torchiana
,
D. F.
,
Hirsch
,
G.
,
Buckley
,
M. J.
,
Hahn
,
C.
,
Allyn
,
J. W.
,
Akins
,
C. W.
,
Drake
,
J. F.
,
Newell
,
J. B.
, and
Austen
,
W. G.
,
1997
, “
Intraaortic Balloon Pumping for Cardiac Support: Trends in Practice and Outcome, 1968 to 1995
,”
J. Thorac. Cardiovasc. Surg.
,
113
(
4
), pp.
758
764
.https://www.ncbi.nlm.nih.gov/pubmed/9104986
14.
Satava
,
R. M.
, Jr.
, and
McGoon
,
D. C.
,
1974
, “
Cardiac Assist With an Intraventricular Balloon
,”
J. Thorac. Cardiovasc. Surg.
,
67
(
5
), pp.
780
787
.https://www.ncbi.nlm.nih.gov/pubmed/4823312
15.
Curtis
,
J. J.
,
McGoon
,
D. C.
, and
Kaye
,
M. P.
,
1977
, “
Cardiac Assist With an Intraventricular Balloon: Hemodynamic Observations With a Clinical Prototype
,”
Surg. Forum
,
28
, pp.
290
291
.https://www.ncbi.nlm.nih.gov/pubmed/617450
16.
Stamatelopoulos
,
S.
,
Zakopoulos
,
N.
,
Saridakis
,
N.
,
Kanakakis
,
J.
,
Stefanou
,
S.
,
Gougoulakis
,
A.
, and
Moulopoulos
,
S.
,
1995
, “
Optimal Conditions of Biventricular Balloon Pumping During Ventricular Fibrillation in the Experimental Animal
,”
Assisted Circulation
, Vol.
4
,
F.
Unger
, ed.,
Springer
,
Berlin
, pp.
42
51
.
17.
Kawel-Boehm
,
N.
,
Maceira
,
A.
,
Valsangiacomo-Buechel
,
E. R.
,
Vogel-Claussen
,
J.
,
Turkbey
,
E. B.
,
Williams
,
R.
,
Plein
,
S.
,
Tee
,
M.
,
Eng
,
J.
, and
Bluemke
,
D. A.
,
2015
, “
Normal Values for Cardiovascular Magnetic Resonance in Adults and Children
,”
J. Cardiovasc. Magn. Reson.
,
17
(
1
), p.
29
.
18.
Grayburn
,
P. A.
,
Carabello
,
B.
,
Hung
,
J.
,
Gillam
,
L. D.
,
Liang
,
D.
,
Mack
,
M. J.
,
McCarthy
,
P. M.
,
Miller
,
D. C.
,
Trento
,
A.
, and
Siegel
,
R. J.
,
2014
, “
Defining ‘Severe’ Secondary Mitral Regurgitation
,”
Emphasizing Integr. Approach
,
64
(
25
), pp.
2792
2801
.https://www.ncbi.nlm.nih.gov/pubmed/25541133
19.
Shepard
,
R. B.
,
Simpson
,
D. C.
, and
Sharp
,
J. F.
,
1966
, “
Energy Equivalent Pressure
,”
Arch. Surg.
,
93
(
5
), pp.
730
740
.
20.
Stergiopulos
,
N.
,
Meister
,
J. J.
, and
Westerhof
,
N.
,
1994
, “
Simple and Accurate Way for Estimating Total and Segmental Arterial Compliance: The Pulse Pressure Method
,”
Ann. Biomed. Eng.
,
22
(
4
), pp.
392
397
.
21.
Nobili
,
M.
,
Morbiducci
,
U.
,
Ponzini
,
R.
,
Del Gaudio
,
C.
,
Balducci
,
A.
,
Grigioni
,
M.
,
Maria Montevecchi
,
F.
, and
Redaelli
,
A.
,
2008
, “
Numerical Simulation of the Dynamics of a Bileaflet Prosthetic Heart Valve Using a Fluid–Structure Interaction Approach
,”
J. Biomech.
,
41
(
11
), pp.
2539
2550
.
22.
Braunwald
,
E.
,
Brockenbrough
,
F. C. J.
,
E. C.
,
Frahm
,
C. J.
, and
Ross
,
J.
, Jr.
,
1961
, “
Left Atrial and Left Ventricular Pressures in Subjects Without Cardiovascular Disease: Observations Eighteen Patients Studied by Transseptal Left Heart Catheterization
,”
Circulation
,
24
(
2
), pp.
267
269
.
23.
Hildebrand
,
D. K.
,
Wu
,
Z. J.
,
Mayer
,
J. E.
, Jr.
, and
Sacks
,
M. S.
,
2004
, “
Design and Hydrodynamic Evaluation of a Novel Pulsatile Bioreactor for Biologically Active Heart Valves
,”
Ann. Biomed. Eng.
,
32
(
8
), pp.
1039
1049
.
24.
Harvey
,
L.
,
Holley
,
C. T.
, and
John
,
R.
,
2014
, “
Gastrointestinal Bleed After Left Ventricular Assist Device Implantation: Incidence, Management, and Prevention
,”
Ann. Cardiothorac. Surg.
,
3
(
5
), pp.
475
479
.https://www.ncbi.nlm.nih.gov/pubmed/25452907
25.
Ündar
,
A.
,
2004
, “
Myths and Truths of Pulsatile and Nonpulsatile Perfusion During Acute and Chronic Cardiac Support
,”
Artif. Organs
,
28
(
5
), pp.
439
443
.https://www.ncbi.nlm.nih.gov/pubmed/15113337
26.
Undar
,
A.
,
Zapanta
,
C. M.
,
Reibson
,
J. D.
,
Souba
,
M.
,
Lukic
,
B.
,
Weiss
,
W. J.
,
Snyder
,
A. J.
,
Kunselman
,
A. R.
,
Pierce
,
W. S.
,
Rosenberg
,
G.
, and
Myers
,
J. L.
,
2005
, “
Precise Quantification of Pressure Flow Waveforms of a Pulsatile Ventricular Assist Device
,”
ASAIO J.
,
51
(
1
), pp.
56
59
.https://www.ncbi.nlm.nih.gov/pubmed/15745135
27.
Ündar
,
A.
,
Eichstaedt
,
H. C.
,
Masai
,
T.
,
Yang
,
S.-Q.
,
Bigley
,
J. E.
,
McGarry
,
M. C.
,
Mueller
,
M.
,
Vaughn
,
W. K.
, and
Fraser
,
C. D.
,
2001
, “
Comparison of Six Pediatric Cardiopulmonary Bypass Pumps During Pulsatile and Nonpulsatile Perfusion
,”
J. Thorac. Cardiovasc. Surg.
,
122
(
4
), pp.
827
829
.
28.
Travis
,
A. R.
,
Giridharan
,
G. A.
,
Pantalos
,
G. M.
,
Dowling
,
R. D.
,
Prabhu
,
S. D.
,
Slaughter
,
M. S.
,
Sobieski
,
M.
,
Undar
,
A.
,
Farrar
,
D. J.
, and
Koenig
,
S. C.
,
2007
, “
Vascular Pulsatility in Patients With a Pulsatile- or Continuous-Flow Ventricular Assist Device
,”
J. Thorac. Cardiovasc. Surg.
,
133
(
2
), pp.
517
524
.
29.
Chen
,
C.-H.
,
Nevo
,
E.
,
Fetics
,
B.
,
Pak
,
P. H.
,
Yin
,
F. C. P.
,
Maughan
,
W. L.
, and
Kass
,
D. A.
,
1997
, “
Estimation of Central Aortic Pressure Waveform by Mathematical Transformation of Radial Tonometry Pressure
,”
Validation Generalized Transfer Funct.
,
95
(
7
), pp.
1827
1836
.https://www.ahajournals.org/doi/full/10.1161/01.CIR.95.7.1827
30.
Cole
,
G. D.
,
Dhutia
,
N. M.
,
Shun-Shin
,
M. J.
,
Willson
,
K.
,
Harrison
,
J.
,
Raphael
,
C. E.
,
Zolgharni
,
M.
,
Mayet
,
J.
, and
Francis
,
D. P.
,
2015
, “
Defining the Real-World Reproducibility of Visual Grading of Left Ventricular Function and Visual Estimation of Left Ventricular Ejection Fraction: Impact of Image Quality, Experience and Accreditation
,”
Int. J. Cardiovasc. Imaging
,
31
(
7
), pp.
1303
1314
.
31.
Clay
,
S.
,
Alfakih
,
K.
,
Radjenovic
,
A.
,
Jones
,
T.
,
Ridgway
,
J. P.
, and
Sinvananthan
,
M. U.
,
2006
, “
Normal Range of Human Left Ventricular Volumes and Mass Using Steady State Free Precession MRI in the Radial Long Axis Orientation
,”
Magma
,
19
(
1
), pp.
41
45
.
32.
Fried
,
J. A.
,
Nair
,
A.
,
Takeda
,
K.
,
Clerkin
,
K.
,
Topkara
,
V. K.
,
Masoumi
,
A.
,
Yuzefpolskaya
,
M.
,
Takayama
,
H.
,
Naka
,
Y.
,
Burkhoff
,
D.
,
Kirtane
,
A.
,
Karmpaliotis
,
D.
,
Moses
,
J.
,
Colombo
,
P. C.
, and
Garan
,
A. R.
,
2018
, “
Clinical and Hemodynamic Effects of Intra-Aortic Balloon Pump Therapy in Chronic Heart Failure Patients With Cardiogenic Shock
,”
J. Heart Lung Transplant.
,
37
(
11
), pp.
1313
1321
.
33.
Erdogan
,
H. B.
,
Goksedef
,
D.
,
Erentug
,
V.
,
Polat
,
A.
,
Bozbuga
,
N.
,
Mansuroglu
,
D.
,
Guler
,
M.
,
Akinci
,
E.
, and
Yakut
,
C.
,
2006
, “
In Which Patients Should Sheathless IABP Be Used? An Analysis of Vascular Complications in 1211 Cases
,”
J. Card. Surg.
,
21
(
4
), pp.
342
346
.
34.
Roy
,
S. K.
,
Howard
,
E. W.
,
Panza
,
J. A.
, and
Cooper
,
H. A.
,
2010
, “
Clinical Implications of Thrombocytopenia Among Patients Undergoing Intra-Aortic Balloon Pump Counterpulsation in the Coronary Care Unit
,”
Clin. Cardiol.
,
33
(
1
), pp.
30
35
.
35.
Trost
,
J. C.
, and
Hillis
,
L. D.
,
2006
, “
Intra-Aortic Balloon Counterpulsation
,”
Am. J. Cardiol.
,
97
(
9
), pp.
1391
1398
.
36.
Cloud
,
G. C.
,
Rajkumar
,
C.
,
Kooner
,
J.
,
Cooke
,
J.
, and
Bulpitt
,
C. J.
,
2003
, “
Estimation of Central Aortic Pressure by SphygmoCor® Requires Intra-Arterial Peripheral Pressures
,”
Clin. Sci.
,
105
(
2
), pp.
219
225
.
37.
DeVore
,
A. D.
,
Mentz
,
R. J.
, and
Patel
,
C. B.
,
2014
, “
Medical Management of Patients With Continuous-Flow Left Ventricular Assist Devices
,”
Curr. Treat. Options Cardiovasc. Med.
,
16
(
2
), pp.
283
283
.
38.
Ji
,
B.
, and
Ündar
,
A.
,
2007
, “
Review Article: Comparison of Perfusion Modes on Microcirculation During Acute and Chronic Cardiac Support: Is There a Difference?
,”
Perfusion
,
22
(
2
), pp.
115
119
.https://journals.sagepub.com/doi/abs/10.1177/0267659107080115
39.
Soucy
,
K. G.
,
Giridharan
,
G. A.
,
Choi
,
Y.
,
Sobieski
,
M. A.
,
Monreal
,
G.
,
Cheng
,
A.
,
Schumer
,
E.
,
Slaughter
,
M. S.
, and
Koenig
,
S. C.
,
2015
, “
Rotary Pump Speed Modulation for Generating Pulsatile Flow and Phasic Left Ventricular Volume Unloading in a Bovine Model of Chronic Ischemic Heart Failure
,”
J. Heart Lung Transplant.
,
34
(
1
), pp.
122
131
.
40.
Shiose
,
A.
,
Nowak
,
K.
,
Horvath
,
D. J.
,
Massiello
,
A. L.
,
Golding
,
L. A. R.
, and
Fukamachi
,
K.
,
2010
, “
Speed Modulation of the Continuous-Flow Total Artificial Heart to Simulate a Physiologic Arterial Pressure Waveform
,”
ASAIO J.
,
56
(
5
), pp.
403
409
.
41.
Ising
,
M.
,
Warren
,
S.
,
Sobieski
,
M. A.
,
Slaughter
,
M. S.
,
Koenig
,
S. C.
, and
Giridharan
,
G. A.
,
2011
, “
Flow Modulation Algorithms for Continuous Flow Left Ventricular Assist Devices to Increase Vascular Pulsatility: A Computer Simulation Study
,”
Cardiovasc. Eng. Technol.
,
2
(
2
), p.
90
.
42.
Deo
,
S. V.
,
Sharma
,
V.
,
Cho
,
Y. H.
,
Shah
,
I. K.
, and
Park
,
S. J.
,
2014
, “
De Novo Aortic Insufficiency During Long-Term Support on a Left Ventricular Assist Device: A Systematic Review and Meta-Analysis
,”
ASAIO J.
,
60
(
2
), pp.
183
188
.
43.
Jezovnik
,
M. K.
,
Gregoric
,
D. I.
, and
Poredos
,
P.
,
2017
, “
Medical Complications in Patients With LVAD Devices
,”
E-J. Cardiol. Pract.
,
14
(
37
), epub.https://www.escardio.org/Journals/E-Journal-of-Cardiology-Practice/Volume-14/Medical-complications-in-patients-with-LVAD-devices
44.
Gharaie
,
S. H.
,
Mosadegh
,
B.
, and
Morsi
,
Y.
,
2017
, “
Towards Computational Prediction of Flow-Induced Damage of Blood Cells Using a Time-Accumulated Model
,”
J. Biomech. Sci. Eng.
,
12
(
4
), p.
17
.https://www.jstage.jst.go.jp/article/jbse/advpub/0/advpub_17-00168/_article/-char/en
45.
Fraser
,
K. H.
,
Zhang
,
T.
,
Taskin
,
M. E.
,
Griffith
,
B. P.
, and
Wu
,
Z. J.
,
2012
, “
A Quantitative Comparison of Mechanical Blood Damage Parameters in Rotary Ventricular Assist Devices: Shear Stress, Exposure Time and Hemolysis Index
,”
ASME J. Biomech. Eng.
,
134
(
8
), p.
081002
.
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