The Human Acellular Vessel for Vascular Reconstruction or Bypass

Lauria, Alexis L; Sen, Indrani; Rasmussen, Todd E.

doi:10.1001/jamasurg.2022.1214

Cited by 15 publications

(9 citation statements)

References 7 publications

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“…However, synthetic expanded polytetrafluoroethylene (ePTFE) arteriovenous grafts (AVG) may be associated with infection rates of up to 9% per patient year and secondary patency of only 70% at one year [ 5 ]. Xenografts and allografts may have similar complications impacting graft patency, including dilatation, stenosis, aneurysm, and host immune response [ 5 , 6 ].…”

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

“…Bioengineered in a bioreactor, HAV is an investigational, shelf-stable human tissue-engineered vascular conduit, which is decellularized to mitigate implant rejection [ 6 ]. HAV has been used in clinical trials as an HD vascular access conduit in ESRD and for vascular reconstruction in PAD and vascular trauma [ 3 , 4 , 6 , 10 , 11 ]. Most recently, HAV has been utilized for humanitarian vascular trauma repair in Ukraine, and enrollment was completed for a Phase II/III vascular trauma trial (V005) to further investigate the use of human acellular vessel (HAV) in vascular trauma repair [ 12 ].…”

Section: Introductionmentioning

confidence: 99%

“…Most recently, HAV has been utilized for humanitarian vascular trauma repair in Ukraine, and enrollment was completed for a Phase II/III vascular trauma trial (V005) to further investigate the use of human acellular vessel (HAV) in vascular trauma repair [ 12 ]. This biologic conduit populated with patient cells may better resist infection [ 4 , 6 , 13 ]. Infection rates were 1.3% per patient year in two phase 2 single-arm trials, and conduits displayed improvement in structural integrity and patency as secondary patency was observed to be 90% at 1 year.…”

Section: Introductionmentioning

confidence: 99%

“…Infection rates were 1.3% per patient year in two phase 2 single-arm trials, and conduits displayed improvement in structural integrity and patency as secondary patency was observed to be 90% at 1 year. This makes HAV a beneficial option for patients with complicated HD vascular access situations, including occlusion, thrombosis, and aneurysm [ 4 , 6 , 13 ].…”

Section: Introductionmentioning

confidence: 99%

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Expanded Utility of Human Acellular Vessel in Hemodialysis Access Surgery and Arterial Aneurysm Repair

Nickerson,

Thamba,

Rao

et al. 2023

Cureus

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Vascular access is essential for hemodialysis (HD) in patients with end-stage renal disease (ESRD). When the standard of care arteriovenous fistula (AVF) is limited, secondary to aneurysmal degeneration, trauma, and thrombus, interposition grafting is a reasonable reconstruction approach. As these grafts and comorbidities place ESRD patients at sustained risk of complications, reconstructions with regenerative medicine biologic conduits hold promise in improving safety and efficacy. Here, a biocompatible human acellular vessel (HAV) is our conduit of interest. With United States Food and Drug Administration use authorization under the Expanded Access Program, we report three cases of complex vascular access surgery with four aneurysm repairs using HAV. Patient selection focused on meeting unmet needs for those without adequate care alternatives, including active access and endoprosthetic stent graft infections, right heart failure due to high-output AVF, and arterial and access outflow aneurysms. In this high-risk expanded access population, operative technical success and interval success for patients given their inherent comorbidities, offer potential expanded utility of HAV in HD access surgery and arterial aneurysm repair.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Expanded Utility of Human Acellular Vessel in Hemodialysis Access Surgery and Arterial Aneurysm Repair

Nickerson,

Thamba,

Rao

et al. 2023

Cureus

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3-D-Druck in der Chirurgie: Relevanz der Bewertung der Technologiereife in Forschungsstudien zum Bioprinting

Laubach,

Hartmann,

Holzapfel

et al. 2024

Chirurgie

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ZusammenfassungBiologische 3‑D-Druckverfahren (sog. Bioprinting) sind eine Erweiterung dessen, was in den American Society for Testing and Materials(ASTM)- und International Organization for Standardization(ISO)-Normen als additive Fertigung definiert ist, und basieren auf dem automatisierten Druck von lebenden Zellen und Biomaterialien. Forschende und Expertinnen und Experten im Bereich der Biomaterialwissenschaften, der Gewebezüchtung und regenerativen Medizin („tissue engineering and regenerative medicine“, TE&RM) verweisen stets auf das Potenzial biologischer 3‑D-Druckverfahren und in Fachartikeln wird regelmäßig dessen baldige klinische Anwendung angekündigt. Wir argumentieren in dieser Arbeit, dass diese Ankündigungen regelhaft verfrüht und kontraproduktiv sind, da sie sich stark auf den technologischen Fortschritt konzentrieren, jedoch in der Regel die kritischen Phasen ignorieren, die durchlaufen werden müssen, um erfolgreich die Translation einer Technologie auf den Gesundheitsmarkt zu erzielen. Die Technologiereifegradskala („technology readiness level“, TRL) ist ein potenziell nützliches Instrument zur Messung der relativen Reife einer Technologie in Bezug auf die Überwindung einer Reihe kritischer Meilensteine. Wir schlagen eine Adaptierung der TRL-Skala vor und nutzen diese, um den aktuellen Stand der Forschung zu biologischen 3‑D-Druckverfahren zu diskutieren. Abschließend geben wir konkrete Empfehlungen zur Optimierung zukünftiger Forschungsprojekte, um den Weg für klinische Anwendungen des biologischen 3‑D-Drucks zu ebnen und damit einen direkten positiven Einfluss auf die chirurgische Patientenversorgung zu erzielen.

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