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Joaquim Cardoso MSc
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March 30, 2023
SOURCE:
Reuters
March 30, 2023
Surgeons have figured out how to turn a vein into an artery in order to avoid amputation in people with severely blocked blood flow to the feet, according to a report published on Wednesday in The New England Journal of Medicine.
The study involved 105 patients whose calf arteries were clogged so severely they developed non-healing wounds and gangrene due to a lack of oxygen-carrying blood able to reach the tissues. All had exhausted other treatment options and were facing amputation.
Veins normally carry blood to the heart, not to the tissues.
Using customized equipment manufactured by study sponsor Limflow Inc, surgeons connected a vein to a clogged artery at a site ahead of the blockage and redirected the arterial blood into the vein.
Next, they deactivated the valves in the vein that usually direct blood to the heart, allowing it to flow toward the oxygen-starved tissues.
Six months later, two-thirds of the patients were still amputation-free, although some had required additional interventions to optimize blood flow, according to study leader Dr. Mehdi Shishehbor of University Hospitals Harrington Heart and Vascular Institute in Cleveland and colleagues.
A quarter of wounds had completely healed, and another 51% were in the process of healing, researchers reported.
In an accompanying editorial, Dr. Douglas Drachman of Massachusetts General Hospital in Boston called the new procedure “a novel — if not audacious — approach.”
Still unclear, is whether the repurposed blood vessels will themselves eventually become clogged.
And are all patients with such limb-threatening blockages likely to benefit, or are some — such as those with kidney failure — likely to have poorer outcomes?, he asked.
Despite those uncertainties, this novel option “offers potential promise for patients who would otherwise often be relegated to amputation,” Drachman wrote.
VIDEO
ORIGINAL PUBLICATION
Transcatheter Arterialization of Deep Veins in Chronic Limb-Threatening Ischemia
NEJM
List of authors.
- Mehdi H. Shishehbor, D.O., M.P.H., Ph.D.,
- Richard J. Powell, M.D.,
- Miguel F. Montero-Baker, M.D.,
- Anahita Dua, M.D.,
- Jorge L. Martínez-Trabal, M.D.,
- Matthew C. Bunte, M.D.,
- Arthur C. Lee, M.D.,
- Andrew S. Mugglin, Ph.D.,
- Joseph L. Mills, M.D.,
- Alik Farber, M.D.,
- and Daniel G. Clair, M.D.
for the PROMISE II Investigators*
Abstract
BACKGROUND
- Approximately 20% of patients with chronic limb-threatening ischemia have no revascularization options, leading to above-ankle amputation.
- Transcatheter arterialization of the deep veins is a percutaneous approach that creates an artery-to-vein connection for delivery of oxygenated blood by means of the venous system to the ischemic foot to prevent amputation.
METHODS
- We conducted a prospective, single-group, multicenter study to evaluate the effect of transcatheter arterialization of the deep veins in patients with nonhealing ulcers and no surgical or endovascular revascularization treatment options.
- The composite primary end point was amputation-free survival (defined as freedom from above-ankle amputation or death from any cause) at 6 months, as compared with a performance goal of 54%.
- Secondary end points included limb salvage, wound healing, and technical success of the procedure.
RESULTS
- We enrolled 105 patients who had chronic limb-threatening ischemia and were of a median age of 70 years (interquartile range, 38 to 89).
- Of the patients enrolled, 33 (31.4%) were women and 45 (42.8%) were Black, Hispanic, or Latino.
- Transcatheter arterialization of the deep veins was performed successfully in 104 patients (99.0%).
- At 6 months, 66.1% of the patients had amputation-free survival.
- According to Bayesian analysis, the posterior probability that amputation-free survival at 6 months exceeded a performance goal of 54% was 0.993, which exceeded the prespecified threshold of 0.977.
- Limb salvage (avoidance of above-ankle amputation) was attained in 67 patients (76.0% by Kaplan–Meier analysis).
- Wounds were completely healed in 16 of 63 patients (25%) and were in the process of healing in 32 of 63 patients (51%).
- No unanticipated device-related adverse events were reported.
CONCLUSIONS
- We found that transcatheter arterialization of the deep veins was safe and could be performed successfully in patients with chronic limb-threatening ischemia and no conventional surgical or endovascular revascularization treatment options. (Funded by LimFlow; PROMISE II study ClinicalTrials.gov number, NCT03970538. opens in new tab.)
Author Affiliations
From University Hospitals Harrington Heart and Vascular Institute, Cleveland (M.H.S.); the Division of Vascular Surgery, Dartmouth–Hitchcock Medical Center, Lebanon, NH (R.J.P.); the Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston (M.F.M.-B., J.L.M.); the Division of Vascular Surgery, Massachusetts General Hospital, Harvard Medical School (A.D.), and the Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston University School of Medicine (A.F.) — both in Boston; the Division of Vascular Surgery, Ponce Health Sciences University, St. Luke’s Episcopal Hospital, Ponce, Puerto Rico (J.L.M.-T.); Saint Luke’s Mid America Heart Institute, Kansas City, MO (M.C.B.); HCA Florida North Florida Hospital, the Cardiac and Vascular Institute, Gainesville (A.C.L.); Paradigm Biostatistics, Anoka, MN (A.S.M.); and the Department of Vascular Surgery, Vanderbilt School of Medicine, Nashville (D.G.C.).
Originally published at https://www.nejm.org
