A concise systematic review: Implantation of the small-diameter tissue-engineered vascular graft in human studies

Q: What are the key findings of this study?

Small-diameter tissue-engineered vascular grafts achieved primary patency of 46-75% in hemodialysis access, 58-86.5% in peripheral bypass, 80-81% in coronary bypass, and 50% in arterial trauma.

Q: What is the clinical evidence from this study?

Study design: Systematic Review. Population: Vascular reconstruction across coronary artery bypass grafting, hemodialysis vascular access, peripheral arterial disease bypass, and acute arterial trauma. Intervention: Small-diameter (<6 mm) tissue-engineered vascular graft (TEVG) vs. Single-arm or autologous vein (in 1 trauma study). Primary outcome: Primary graft patency.

Q: What does this research mean for the field?

Small-diameter tissue-engineered vascular grafts achieve primary patency rates ranging from 46–75% in hemodialysis access, 58–86.5% in peripheral bypass, 80–81% in coronary bypass, and 50% in arterial trauma, with infrequent immunologic rejection. Novelty: ClaimNovelty.SYNTHESIS. Consensus alignment: ConsensusAlignment.NEUTRAL.

Q: What question did this study set out to answer?

To summarize human clinical studies evaluating small-diameter (<6 mm) tissue-engineered vascular graft implantation, focusing on graft types, cell sources, patency rates, and rejection events across clinical indications.

Rafaela Andira Ledyastatin; Yan Efrata Sembiring; Ito Puruhito; Ferdiansyah Ferdiansyah; Heri Suroto

doi:10.24969/hvt.2026.692

October 20, 2026Heart Vessels and TransplantationOpen Access

A concise systematic review: Implantation of the small-diameter tissue-engineered vascular graft in human studies

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Key result

Tissue-engineered vascular grafts demonstrate primary patency up to ~87% across diverse arterial reconstructions.

Why the study?

Small-diameter tissue-engineered vascular grafts have been proposed as alternatives to autologous and synthetic conduits for vascular reconstruction, but their clinical translation across different indications remained incompletely characterized.

Does implantation of small-diameter (<6 mm) tissue-engineered vascular grafts achieve acceptable graft patency and low immunologic rejection in human patients undergoing coronary, peripheral, hemodialysis-access, or traumatic vascular reconstruction?

Key Points

To summarize human clinical studies evaluating small-diameter (<6 mm) tissue-engineered vascular graft implantation, focusing on graft types, cell sources, patency rates, and rejection events across clinical indications.
Conducted a PRISMA-compliant systematic review searching PubMed and Cochrane CENTRAL from inception through December 31, 2022.
Screened 98 records and identified 9 eligible human studies (8 clinical trials/cohort studies and 1 case series) evaluating tubular vascular grafts with an inner diameter <6 mm.
Evaluated conduits included autologous cryopreserved vein (n=1 study), autologous cell-seeded synthetic ePTFE (n=2), allogeneic bioengineered acellular vessels (n=3), and xenogeneic bovine carotid artery grafts (n=3).
Primary patency ranged from 46–75% for hemodialysis access (n=3), 58–86.5% for peripheral arterial bypass (n=3), 80–81% for coronary bypass (n=2), and was 50% (versus 71% for autologous vein) in the acute arterial trauma study (n=1).
Immunologic rejection events were infrequent across graft types, though pseudoaneurysm and thrombosis occurred with allogeneic and synthetic grafts, respectively, and no randomized comparisons against autologous vessels were identified.

Study Design

Type

Systematic Review

Structured PICO

Does implantation of small-diameter (<6 mm) tissue-engineered vascular grafts achieve acceptable graft patency and low immunologic rejection in human patients undergoing coronary, peripheral, hemodialysis-access, or traumatic vascular reconstruction?

P

Population

Human patients across 9 clinical studies (at least 272 participants) undergoing implantation of small-diameter (<6 mm) tissue-engineered vascular grafts for coronary bypass, hemodialysis access, peripheral arterial disease bypass, or acute arterial trauma, followed for up to 9.1 years.

I

Intervention

Tubular, small-diameter (<6 mm inner diameter) tissue-engineered or bioengineered vascular grafts (TEVGs), including autologous cryopreserved vein grafts re-seeded with autologous endothelial cells (1 study), synthetic expanded polytetrafluoroethylene (ePTFE) grafts seeded with autologous venous endothelial cells or adipose-derived stromal vascular fraction cells (2 studies), allogeneic bioengineered human acellular vessels derived from smooth muscle cells or dermal fibroblasts (3 studies), and xenogeneic bovine carotid artery grafts (Artegraft, processed by ficin enzymatic digestion and dialdehyde-starch tanning) (3 studies).

C

Comparator

Mostly single-arm studies with no comparator (8 of 9 studies); 1 retrospective trauma cohort compared xenogeneic bovine carotid artery graft (n=12) against autologous vein (n=18), and 1 hemodialysis study compared results against a historical ePTFE benchmark.

O

Outcome

Primary graft patency across clinical indications (ranging from 6 months to 6 years of follow-up)hard clinical

Limitations

Original screening counts at the full-text eligibility stage were reconstructed and require verification against original search records
No formal risk-of-bias or methodological quality appraisal was performed on the included studies, eight of which were single-arm cohorts or a case series
No included study directly compared a small-diameter TEVG against autologous vein or artery in a randomized design
Significant heterogeneity across the four clinical indications in flow conditions, target-vessel diameter, thrombogenic environment, surveillance intensity, and patency definitions
Literature search was only updated through December 31, 2022 and restricted to English-language publications
Original screening counts at the full-text eligibility stage were reconstructed for internal consistency and require verification against original records
No formal risk-of-bias or methodological quality appraisal was performed on the included studies, which were predominantly single-arm cohorts or case series
Substantial heterogeneity across the four clinical indications in flow conditions, target-vessel diameter, thrombogenic environment, surveillance intensity, and patency definitions
Literature search was last updated in December 2022 and restricted to English-language publications

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Implication

Small-diameter (<6 mm) tissue-engineered vascular grafts show promising intermediate-term patency and low immunologic rejection across coronary, peripheral, and dialysis-access settings in early human studies, but head-to-head randomized trials against autologous conduits are entirely lacking.

Abstract

Objective: Small-diameter tissue-engineered vascular grafts (TEVGs) have been proposed as alternatives to autologous and synthetic conduits for vascular reconstruction, but their clinical translation across different indications remains incompletely characterized.This systematic review aimed to summarize human clinical studies of small-diameter (<6 mm) TEVG implantation, describing graft types, cell sources, patency outcomes, and rejection events across coronary, peripheral, hemodialysis-access, and traumatic indications.Methods: This review was conducted and reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 statement (43).PubMed and the Cochrane Library (CENTRAL) were searched from database inception to December 31, 2022, using terms combining "small-diameter," "tissueengineered vascular graft," and "human implantation."Two independent reviewers screened records using Covidence, with disagreements resolved by a third reviewer.Eligible studies reported human implantation of a tubular, small-diameter (<6 mm inner diameter) vascular graft with extractable patency or rejection-outcome data.Results: Of 98 records identified, 9 studies (8 clinical trials/cohort studies and 1 case series) met eligibility criteria.Included studies evaluated autologous cryopreserved vein grafts (n=1 study), synthetic ePTFE grafts seeded with autologous cells (n=2), allogeneic bioengineered acellular vessels (n=3), and xenogeneic bovine carotid artery grafts (n=3), applied respectively to coronary artery bypass grafting (n=2 studies), hemodialysis vascular access (n=3), peripheral arterial disease bypass (n=3), and acute arterial trauma (n=1).Primary patency ranged from 46-75% in hemodialysis-access studies, 58-86.5% in peripheral bypass studies, and 80-81% in coronary bypass studies, and was 50% (versus 71% for autologous vein) in the single trauma study.Immunologic rejection events were infrequent across graft types, though pseudoaneurysm and thrombosis were reported with allogeneic and synthetic grafts, respectively.Conclusion: Human implantation of small-diameter TEVGs has increased over the past decade, and human cell seeding or recellularization was used in nearly all reported studies.However, patency and complication profiles differ substantially by clinical indication, and no randomized comparison against autologous vein or artery has been performed.Stratified, PRISMA-compliant reporting and head-to-head comparative trials are needed before the comparative performance of small-diameter TEVGs across clinical settings can be established.

Discussion

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Cite This Study

Ledyastatin et al. (2026) conducted a systematic review in Vascular reconstruction across coronary artery bypass grafting, hemodialysis vascular access, peripheral arterial disease bypass, and acute arterial trauma. Small-diameter (<6 mm) tissue-engineered vascular graft (TEVG) vs. Single-arm or autologous vein (in 1 trauma study) was evaluated on Primary graft patency. Small-diameter tissue-engineered vascular grafts achieved primary patency of 46-75% in hemodialysis access, 58-86.5% in peripheral bypass, 80-81% in coronary bypass, and 50% in arterial trauma.

synapsesocial.com/papers/6aee6b8671a7594806220a12 https://doi.org/10.24969/hvt.2026.692

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A concise systematic review: Implantation of the small-diameter tissue-engineered vascular graft in human studies

Key Points

Study Design

Structured PICO

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

A concise systematic review: Implantation of the small-diameter tissue-engineered vascular graft in human studies

Key Points

Study Design

Structured PICO

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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