PMID- 37890643
OWN - NLM
STAT- MEDLINE
DCOM- 20240122
LR  - 20240201
IS  - 1097-6809 (Electronic)
IS  - 0741-5214 (Linking)
VI  - 79
IP  - 2
DP  - 2024 Feb
TI  - Outcomes of lower extremity arterial bypass using the Human Acellular Vessel in 
      patients with chronic limb-threatening ischemia.
PG  - 348-357.e2
LID - S0741-5214(23)02172-9 [pii]
LID - 10.1016/j.jvs.2023.10.040 [doi]
AB  - OBJECTIVE: Patients with chronic limb-threatening ischemia (CLTI) and no great 
      saphenous vein to use as a conduit for arterial bypass have a high risk for 
      amputation despite advances in medical and endovascular therapies. This report 
      presents findings from a U.S. Food and Drug Administration (FDA) supported study 
      of the Human Acellular Vessel (HAV) (Humacyte Inc.) used as a conduit for 
      arterial bypass in patients with CLTI and inadequate or absent autologous 
      conduit. METHODS: The HAV is a 6-mm, 40-cm vessel created from human vascular 
      smooth muscle cells seeded onto a polyglycolic acid scaffold pulsed in a 
      bioreactor for 8 weeks as cells proliferate and the scaffold dissolves. The 
      resultant vessel is decellularized, creating a nonimmunogenic conduit composed of 
      collagen, elastin, and extracellular matrix. The FDA issued an Investigational 
      New Drug for an intermediate-sized, single-center study of the HAV under the 
      agency's Expanded Access Program in patients with advanced CLTI and inadequate or 
      absent autologous conduit. Technical results and clinical outcomes were analyzed 
      and reported. RESULTS: Between March 2021 and July 2023, 29 patients (20 males; 
      mean age, 71 +/- 11 years) underwent limb salvage operation using the HAV as a 
      bypass conduit. Most patients had advanced CLTI (Rutherford class 5/6 in 72%; 
      wound, ischemia, and foot infection stage 3/4 in 83%), and 97% had previously 
      failed revascularization(s) of the extremity. Two HAVs were sewn together to 
      attain the needed bypass length in 24 patients (83%). Bypasses were to tibial 
      arteries in 23 patients (79%) and to the popliteal artery in 6 (21%). Technical 
      success was 100%, and the 30-day mortality rate was 7% (2 patients). With 100% 
      follow-up (median, 9.3 months), the limb salvage rate was 86% (25/29 patients). 
      There were 16 reinterventions to restore secondary patency, of which 15 (94%) 
      were successful. Primary and secondary patency of the HAV at 9 months were 59% 
      and 71%, respectively. CONCLUSIONS: The HAV has demonstrated short- to 
      intermediate-term safety and efficacy as an arterial bypass conduit in a complex 
      cohort of patients with limb-threatening ischemia and no autologous options. This 
      experience using the FDA's Expanded Access Program provides real-world data to 
      inform regulatory deliberations and future trials of the HAV, including the study 
      of the vessel as a first-line bypass conduit in less severe cases of chronic limb 
      ischemia.
CI  - Copyright (c) 2023 Society for Vascular Surgery. Published by Elsevier Inc. All 
      rights reserved.
FAU - Cifuentes, Sebastian
AU  - Cifuentes S
AD  - Division of Vascular and Endovascular Surgery, Mayo Clinic, Rochester, MN.
FAU - Sen, Indrani
AU  - Sen I
AD  - Division of Vascular and Endovascular Surgery, Mayo Clinic, Rochester, MN.
FAU - Shuja, Fahad
AU  - Shuja F
AD  - Division of Vascular and Endovascular Surgery, Mayo Clinic, Rochester, MN.
FAU - Mendes, Bernardo C
AU  - Mendes BC
AD  - Division of Vascular and Endovascular Surgery, Mayo Clinic, Rochester, MN.
FAU - Colglazier, Jill J
AU  - Colglazier JJ
AD  - Division of Vascular and Endovascular Surgery, Mayo Clinic, Rochester, MN.
FAU - Schaller, Melinda S
AU  - Schaller MS
AD  - Division of Vascular and Endovascular Surgery, Mayo Clinic, Rochester, MN.
FAU - Kalra, Manju
AU  - Kalra M
AD  - Division of Vascular and Endovascular Surgery, Mayo Clinic, Rochester, MN.
FAU - Morrison, Jonathan J
AU  - Morrison JJ
AD  - Division of Vascular and Endovascular Surgery, Mayo Clinic, Rochester, MN.
FAU - DeMartino, Randall R
AU  - DeMartino RR
AD  - Division of Vascular and Endovascular Surgery, Mayo Clinic, Rochester, MN.
FAU - Rasmussen, Todd E
AU  - Rasmussen TE
AD  - Division of Vascular and Endovascular Surgery, Mayo Clinic, Rochester, MN. 
      Electronic address: rasmussen.todd@mayo.edu.
LA  - eng
PT  - Journal Article
DEP - 20231026
PL  - United States
TA  - J Vasc Surg
JT  - Journal of vascular surgery
JID - 8407742
SB  - IM
MH  - Male
MH  - Humans
MH  - Middle Aged
MH  - Aged
MH  - Aged, 80 and over
MH  - Chronic Limb-Threatening Ischemia
MH  - *Blood Vessel Prosthesis Implantation/adverse effects
MH  - Vascular Patency
MH  - Treatment Outcome
MH  - *Peripheral Arterial Disease/diagnostic imaging/surgery
MH  - Risk Factors
MH  - Lower Extremity/blood supply
MH  - Ischemia/diagnostic imaging/surgery
MH  - Limb Salvage/methods
MH  - Retrospective Studies
OTO - NOTNLM
OT  - Bypass
OT  - Chronic-limb threatening ischemia
OT  - Peripheral arterial disease
OT  - Tissue-engineered vascular graft
OT  - Vascular prosthesis
COIS- Disclosures T.E.R. has served in a clinical advisory role for Humacyte, Inc., the 
      funds for which are paid to the Mayo Clinic; Humacyte provides funding to support 
      the performance of this IND study to Mayo Clinic. The other authors have no 
      competing interests.
EDAT- 2023/10/28 11:42
MHDA- 2024/01/22 06:43
CRDT- 2023/10/27 19:29
PHST- 2023/09/13 00:00 [received]
PHST- 2023/10/13 00:00 [revised]
PHST- 2023/10/17 00:00 [accepted]
PHST- 2024/01/22 06:43 [medline]
PHST- 2023/10/28 11:42 [pubmed]
PHST- 2023/10/27 19:29 [entrez]
AID - S0741-5214(23)02172-9 [pii]
AID - 10.1016/j.jvs.2023.10.040 [doi]
PST - ppublish
SO  - J Vasc Surg. 2024 Feb;79(2):348-357.e2. doi: 10.1016/j.jvs.2023.10.040. Epub 2023 
      Oct 26.