History, progress and future challenges of artificial blood vessels: a narrative review

doi:10.12336/biomatertransl.2022.01.008

Biomaterials Translational ›› 2022, Vol. 3 ›› Issue (1): 81-98.doi: 10.12336/biomatertransl.2022.01.008

• REVIEW • Previous Articles

History, progress and future challenges of artificial blood vessels: a narrative review

Ke Hu^1,#, Yuxuan Li^1,#, Zunxiang Ke², Hongjun Yang³, Chanjun Lu¹, Yiqing Li¹, Yi Guo¹^,⁴^,^*(), Weici Wang¹^,^*()

1 Department of Vascular Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei Province, China
2 Department of Emergency Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei Province, China
3 Key Laboratory of Green Processing and Functional New Textile Materials of Ministry of Education, Wuhan Textile University, Wuhan, Hubei Province, China
4 Clinical Centre of Human Gene Research, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei Province, China

Received:2022-01-22 Revised:2022-02-24 Accepted:2022-03-01 Online:2022-03-28 Published:2022-03-28
Contact: Yi Guo,hxshuyun@hotmail.com;Weici Wang,weiciwang@gmail.com.
About author:Yi Guo, hxshuyun@hotmail.com;
Weici Wang, weiciwang@gmail.com.
# Author Equally.

Abstract

Abstract:

Cardiovascular disease serves as the leading cause of death worldwide, with stenosis, occlusion, or severe dysfunction of blood vessels being its pathophysiological mechanism. Vascular replacement is the preferred surgical option for treating obstructed vascular structures. Due to the limited availability of healthy autologous vessels as well as the incidence of postoperative complications, there is an increasing demand for artificial blood vessels. From synthetic to natural, or a mixture of these components, numerous materials have been used to prepare artificial vascular grafts. Although synthetic grafts are more appropriate for use in medium to large-diameter vessels, they fail when replacing small-diameter vessels. Tissue-engineered vascular grafts are very likely to be an ideal alternative to autologous grafts in small-diameter vessels and are worthy of further investigation. However, a multitude of problems remain that must be resolved before they can be used in biomedical applications. Accordingly, this review attempts to describe these problems and provide a discussion of the generation of artificial blood vessels. In addition, we deliberate on current state-of-the-art technologies for creating artificial blood vessels, including advances in materials, fabrication techniques, various methods of surface modification, as well as preclinical and clinical applications. Furthermore, the evaluation of grafts both in vivo and in vitro, mechanical properties, challenges, and directions for further research are also discussed.

Key words: animal models, artificial blood vessel, biomaterials, in vivo evaluation, tissue engineering, vascular graft

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Vessel type	Materials	Advantages	Disadvantages	References
Synthetic polymers	ePTFE (Gore-Tex), PET (Dacron), PU, PCL, PLCL, PLA, PGS.	Excellent mechanical properties. Easy availability. Mass production. Easy surgical suturing. Preventing vascular burst. Can be stored for off-the-shelf use.	Causes thrombosis, intimal hyperplasia, calcification, and chronic inflammation. No growth potential. Poor haemocompatibility. Compliance mismatch.	46, 47, 49, 51, 72
Natural biomaterials	Silk fibroin, collagen, elastin, chitosan, bacterial cellulose	Excellent biocompatibility. Enhanced biological signalling. Tunable mechanical properties.	Weak mechanical strength. Causes vascular graft dilation and aneurysms. Easy degradation. Overly complex designs. Difficulty in translation.	10, 52-57, 66
Decellularised vessels	Animal artery, umbilical artery, umbilical vein	Low immunogenicity. Preserved extracellular matrix, meso- and microvasculature.	Increased thrombogenicity. Host immune response. Difficulty in precise recellularisation. Calcification.	67-69

Vessel type	Materials	Advantages	Disadvantages	References
Synthetic polymers	ePTFE (Gore-Tex), PET (Dacron), PU, PCL, PLCL, PLA, PGS.	Excellent mechanical properties. Easy availability. Mass production. Easy surgical suturing. Preventing vascular burst. Can be stored for off-the-shelf use.	Causes thrombosis, intimal hyperplasia, calcification, and chronic inflammation. No growth potential. Poor haemocompatibility. Compliance mismatch.	46, 47, 49, 51, 72
Natural biomaterials	Silk fibroin, collagen, elastin, chitosan, bacterial cellulose	Excellent biocompatibility. Enhanced biological signalling. Tunable mechanical properties.	Weak mechanical strength. Causes vascular graft dilation and aneurysms. Easy degradation. Overly complex designs. Difficulty in translation.	10, 52-57, 66
Decellularised vessels	Animal artery, umbilical artery, umbilical vein	Low immunogenicity. Preserved extracellular matrix, meso- and microvasculature.	Increased thrombogenicity. Host immune response. Difficulty in precise recellularisation. Calcification.	67-69

	Artery diameter	Usage sites	Indications	Main challenges	Commercial materials
Large	> 8 mm	Aortoiliac arteries.	Open aortic aneurysm repair. Coarctation of the aorta.	Weak mechanical durability. Compliance mismatch. Aneurysmal-like dilation.	Non-degradable materials: PET, ePTFE
Medium	6–8 mm	Carotid artery. Femoral artery.	Similar to large	Similar to large	Similar to large
Small	< 6 mm	Coronary arteries. Infrainguinal arteries (below the inguinal ligament). Infrageniculate arteries (below the knee). Coronary artery bypass.	Arteriovenous shunts.Coronary artery bypass. Peripheral arterial occlusive disease.	Stenosis/occlusion caused by thrombosis or intimal hyperplasia. Low haemocompatibility.	Autologous vessels: ITA, SV

	Artery diameter	Usage sites	Indications	Main challenges	Commercial materials
Large	> 8 mm	Aortoiliac arteries.	Open aortic aneurysm repair. Coarctation of the aorta.	Weak mechanical durability. Compliance mismatch. Aneurysmal-like dilation.	Non-degradable materials: PET, ePTFE
Medium	6–8 mm	Carotid artery. Femoral artery.	Similar to large	Similar to large	Similar to large
Small	< 6 mm	Coronary arteries. Infrainguinal arteries (below the inguinal ligament). Infrageniculate arteries (below the knee). Coronary artery bypass.	Arteriovenous shunts.Coronary artery bypass. Peripheral arterial occlusive disease.	Stenosis/occlusion caused by thrombosis or intimal hyperplasia. Low haemocompatibility.	Autologous vessels: ITA, SV

	Burst pressure (mmHg)	Compliance (%/100 mmHg)
Values for artificial blood vessels^{12, 91}	>1000	10-20
Dog femoral artery¹¹⁸	2895 ± 263	10.3 ± 2.3
Human internal mammary artery¹¹⁹	3196 ± 1264	11.5 ± 3.9
Biodegradable chitosan vascular grafts (with 4 mm inner diameter)¹¹⁸	1688 ± 236	5.7 ± 1.3
Tissue-engineered blood vessels¹³	3490 ± 892	3.4 ± 1.6
Expanded polytetrafluoroethylene grafts¹¹⁹	–	0.51
Silk fibroin grafts¹¹⁹	–	1.90

History, progress and future challenges of artificial blood vessels: a narrative review

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Animal model	Characteristics	Application inner diameter (mm)	Common length (mm)	Longest implantation period	Implantation site	References
Sheep	Similar cardiovascular physiology, endothelialisation mechanisms and thrombogenicity mechanisms to humans. Suitable size and long-term studies possible.Higher incidence of hypercoagulability.	4–6	80–100	9 months	Carotid artery	48, 74
		4–6	60–100	3 months	Arteriovenous graft	129
Pig	Similar vascular physiology and anatomy to humans. Well established as a model for assessing vascular grafts. Mount an extensive immune response to implanted tissues.	3–6	30–100	6 months	Iliac artery	130
		3–6	10–100	4 weeks	Carotid artery	52
Dog	Lack of spontaneous endothelialisation and immune response restricts study lengths. Ease of accessing vessel due to thin skin. Thrombogenicity mechanisms and vessel viscoelastic properties differ from humans.	3–6	30–50	6 months	Abdominal artery	131
		3–6	30–50	1 year	Carotid artery	119
Baboon	Physiology and cardiovascular anatomy are the most similar to humans. Suitable for a wide range of non-invasive imaging techniques adapted from humans. High cost and ethical concerns associated with using primates in medical research.	3–6	30–50	6 months	Arteriovenous graft	26
Rabbit	Similar endothelialisation rates and thrombogenicity mechanisms to humans. Demanding higher anticoagulant function. Limited to short-term studies.	1–4	5–30	12 months	Carotid artery	94, 132
		1–4	5–30	2 weeks	Femoral artery	133
		1–4	5–30	3 months	Abdominal artery	134
Rat	Large sample size. Wide variety of transgenic lines. Allows exploration of genetic/molecular mechanisms. Ideal for biocompatibility and cell infiltration studies.	1–3	5–30	18 months	Abdominal artery	73, 135
Rat		1–3	5–10	12 weeks	Carotid artery	136
Mouse		0.5–1	3–10	6 months	Carotid artery	137

Intervention/treatment	Number of patients	Condition/disease	Years	Trial ID/phase	Testing status
Device: Synthetic vascular grafts	207	Peripheral arterial occlusive disease	2010–2013	NCT01113892/NA	Completed
Device: HAVG graft implantation	40	End-stage renal disease Kidney failure, chronic	2012–2016	NCT01744418/NA	Active, not recruiting
Device: FUSION Vascular Graft	117	Peripheral arterial occlusive disease (PAOD)	2009–2013	NCT01601496/NA	Terminated
Device: POSS-PCU vascular graft	30	Renal insufficiency	2021–2025	NCT02301312/NA	Not yet recruiting
Combination Product: Tissue Engineered Vascular Grafts	4	Single ventricle cardiac anomaly	2009–2017	NCT01034007/Phase 1	Completed
Device: ProEndoTecc Vascular Graft	33	Peripheral arterial disease Peripheral vascular disease	2010–2012	NCT01095237/NA	Terminated
Device: ASC coated ePTFE vascular graft Device: Propaten graft	60	Lower limb ischemia	2011–2022	NCT01305863/NA	Active, not recruiting
Biological: natural human collagen arteriovenous graft for haemodialysis access	10	End stage renal disease	2021–2022	NCT04905511/Phase 1	Recruiting
Device: POSS-PCU vascular graft	30	Renal insufficiency	2021–2025	NCT02301312/NA	Not yet recruiting
Procedure: Revascularisation using a BIOPROTEC graft	45	Peripheral artery disease	2018–2023	NCT04018846/NA	Recruiting
Device: Expanded polytetrafluoroethylene graft Device: Bovine carotid artery graft	10	End stage renal disease Haemolysis Arteriovenous graft	2015–2018	NCT03300024/NA	Terminated (Funding ended)
Device: Expedial vascular access graft	172	End stage renal disease	2004–2006	NCT00131872/Phase 2	Terminated
Device: Covera vascular covered stent	100	Arteriovenous fistula	2020–2023	NCT04261686/NA	Enrolling by invitation
Device: Endovascular revascularisation of peripheral arteries	150	Vascular diseases, peripheral	2021–2022	NCT04765566/NA	Active, not recruiting
Device: InnAVasc arteriovenous graft surgical implant	26	Kidney failure, chronicRenal dialysis	2019–2021	NCT03645681/NA	Active, not recruiting
Procedure: blood sampling procedurethe vascular prosthesis manufactured by electrospinning	120	Arterial occlusive disease	2014–2015	NCT02255188/NA	Completed
Procedure: revascularisation Device: Propaten® Device: Crude PTFE	228	Ischemia lesions	2018–2023	NCT03430076/NA	Recruiting
Device: Paclitaxel-eluting graft	20	Haemodialysis access failure	2018–2023	NCT04285073/NA	Recruiting
Device: GORE PROPATEN vascular graft Procedure: Disadvantaged autologous vein graft	31	Peripheral arterial occlusive disease	2007–2010	NCT00617279/Phase 4	Terminated (study terminated due to low enrolment)
Device: EvoCit Device: EvoHep	38	Kidney diseases Haemodialysis complication End stage renal disease	2018–2019	NCT03887468/	Completed
Combination product: Tissue engineered vascular grafts	24	Cardiovascular diseases	2020–2025	NCT04467671/Phase 2	Recruiting

Company	Product name	Material	Details and modification	Indications for use
Atrium Medical Corporation	Flixene IFG Vascular graft	ePTFE	Very strong and durable with three layers	Arterial vascular reconstruction/segmental bypass/arteriovenous vascular access
Bard Peripheral Vascular, Inc.	Venaflo^TM II Vascular graft	ePTFE	Cuffed to promote good hemodynamic performance	Subcutaneous arteriovenous conduits for blood access only
Edwards Life Sciences	Edwards Lifespan reinforced expanded PTFE vascular graft	ePTFE	Higher crush and kink resistance	Bypass or reconstruction of diseased or occluded blood vessels/arteriovenous shunts
Maquet Cardiovascular, LLC	FUSION Vascular Graft	ePTFE	Two layers fused with a proprietary polycarbonate-urethane adhesive	Peripheral artery repair or replacement/vascular access
	FUSION^TM and FUSION^TM Bioline Vascular Grafts	ePTFE and PET	Two layers with heparin/albumin coating on the interior surface	Peripheral artery repair or replacement
	EXXCEL^TM Soft ePTFE Vascular Grafts	ePTFE	featuring a GUIDELINE® stripe to facilitate proper graft alignment.	Peripheral arteries (iliac, femoral, popliteal, infrageniculate vessels, axillary, renal) repair or replacement/vascular access
InterVascular SAS	InterGard Heparin	PET	Heparin bonded collagen coating	Peripheral artery replacement
PECA Labs, Inc.	ExGraft and ExGraft Carbon EPTFE Vascular Graft	ePTFE	A radiopaque ink applied to the surface and the exGraft Carbon ePTFE vascular graft coating with carbon	Peripheral artery repair or replacement/dialysis access
Vascular Flow Technologies Ltd.	Spiral Flow^TM Peripheral Vascular Graft	ePTFE	Propagating spiral flow through the graft and into the distal circulation, reinforced	Bypass or reconstruction of occluded or diseased peripheral arterial blood vessels above or below the knee
Vascutek Ltd.	Vascutek Gelsoft Plus ERS Vascular Graft	PET	External polypropylene support, gelatine-sealed, knitted polyester grafts	Indicated for extra anatomical vascular repair, primarily for axillo-femoral/bi-femoral bypass and femoropopliteal reconstruction
	Vascutek Gelseal^TM Vascular Grafts	PET	Knitted, gelatine impregnated	Indicated for replacement or bypass of abdominal arteries afflicted with aneurysmal or occlusive disease
	Vascutek Gelsoft^TM Vascular Grafts	PET	Knitted, gelatine impregnated, zero porosity	Indicated for abdominal and peripheral vascular repair
	Vascutek Gelsoft^TM Plus Vascular Grafts	PET	Knitted, gelatine impregnated, dilation resistant	Indicated exclusively for abdominal and peripheral vascular repair
W.L. Gore & Associates, Inc.	Gore-Tex	ePTFE	Unmodified	Vascular access
	Gore-Tex Stretch	ePTFE	Stretch
	Gore Propaten	ePTFE	Reduced thrombogenicity through covalently binding to bioactive heparin

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