Outcomes of Arterial Bypass With the Human Acellular Vessel for Chronic Limb-Threatening Ischemia Performed Under the FDA Expanded Access Program

Indrani Sen; W Darrin Clouse; Alexis L Lauria; Daniel R Calderon; Peter B Anderson; Randall R DeMartino; Todd E Rasmussen

doi:10.1016/j.mayocp.2023.05.004

Outcomes of Arterial Bypass With the Human Acellular Vessel for Chronic Limb-Threatening Ischemia Performed Under the FDA Expanded Access Program

Mayo Clin Proc. 2024 Jan;99(1):57-68. doi: 10.1016/j.mayocp.2023.05.004. Epub 2023 Aug 3.

Authors

Indrani Sen¹, W Darrin Clouse², Alexis L Lauria³, Daniel R Calderon⁴, Peter B Anderson⁵, Randall R DeMartino⁵, Todd E Rasmussen⁶

Affiliations

¹ Vascular and Endovascular Surgery, Mayo Clinic Health Systems, Eau Claire, WI.
² Division of Vascular and Endovascular Surgery, University of Virginia, Charlottesville, VA.
³ Department of Surgery, Uniformed Services University of the Health Sciences and Walter Reed National Military Medical Center, Bethesda, MD.
⁴ Heart and Vascular Institute, University of Pittsburgh Medical Center, Harrisburg, PA.
⁵ Division of Vascular and Endovascular Surgery, Department of Surgery, Mayo Clinic, Rochester, MN.
⁶ Division of Vascular and Endovascular Surgery, Department of Surgery, Mayo Clinic, Rochester, MN; Walter Reed National Military Medical Center, Bethesda, MD. Electronic address: https://twitter.com/@trasmussen_md.

PMID: 37542500
DOI: 10.1016/j.mayocp.2023.05.004

Abstract

Objective: To report outcomes of the human acellular vessel (HAV) implanted for limb salvage through the Food and Drug Administration (FDA) Expanded Access Program for patients with chronic limb-threatening ischemia with no autologous conduit.

Methods: The HAV is a bioengineered vascular conduit designed with human vascular smooth muscle cells. The product is under regulatory study. From April 2019 to November 2021, the HAV was implanted in 14 patients (12 men; mean age, 62±14 years) at 3 US centers. Each case was performed with a single-use investigational new drug Expanded Access Program issued by the FDA. Institutional review board approval was obtained; technical and clinical outcomes were analyzed.

Results: A single 6-mm-diameter (40-cm-long) HAV was implanted in 9 patients; 5 patients required 2 HAVs sewn together as a composite. Technical success was 100%. Median follow-up was 12 (range, 1 to 41) months. Primary and secondary patency rates were 72% and 81% at 12 months; assisted primary patency was attained in 4 patients. Amputation-free survival was 93% at 6 months and 77% at 12 months. All patients with a patent HAV experienced clinical improvement with no HAV-related infections or adverse events. There were 4 deaths in the cohort, late mortality unrelated to the HAV.

Conclusion: The HAV is a safe and effective "off-the-shelf" biologic conduit. This experience from the FDA Expanded Access Program in this population with few alternative limb salvage options will help guide regulatory deliberations for patients with lower extremity ischemia and no autologous bypass conduit options.

MeSH terms

Aged
Chronic Limb-Threatening Ischemia*
Humans
Ischemia / surgery
Lower Extremity / blood supply
Male
Middle Aged
Peripheral Arterial Disease* / surgery
Retrospective Studies
Risk Factors
Treatment Outcome
United States
United States Food and Drug Administration
Vascular Patency