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Transcatheter arterialization of deep veins safe and effective in chronic limb-threatening ischemia: NEJM

Written By : Jacinthlyn Sylvia |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 31 March 2023 5:15 AM  |  Updated On 31 March 2023 6:27 AM
Transcatheter arterialization of deep veins safe and effective in chronic limb-threatening ischemia: NEJM
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A new study published in The New England Journal of Medicine suggests that in patients with persistent limb-threatening ischemia who had no other choices for therapy, such as traditional surgery or endovascular revascularization, transcatheter arterialization of the deep veins proved safe and effective.

Researchers have found in The PROMISE II U.S. pivotal clinical trial that minimally invasive LimFlow therapy enabled most patients to avoid amputation and experience wound healing. The procedure is designed to bypass blocked arteries in the leg and rush blood back into the foot through the veins.

Amputations above the ankle are required in 20% of patients with persistent limb-threatening ischemia due to lack of revascularization alternatives. A percutaneous procedure called transcatheter arterialization of the deep veins establishes an artery-to-vein link in order to transfer oxygenated blood via the venous system to the ischemic foot and avoid amputation. In order to determine the effectiveness of transcatheter arterialization of the deep veins in such circumstances, Mehdi Shishehbor and colleagues undertook this study.

In order to assess the effectiveness of transcatheter arterialization of the deep veins in patients with non healing wounds and no surgical or endovascular revascularization therapy options, researchers undertook a single-group, prospective, multicenter trial. Amputation-free survival, defined as the absence of above-ankle amputation or death from any cause, was the composite primary end objective at 6 months, exceeding the performance target of 54%. Lung preservation, wound healing, and technical success of the treatment were considered secondary end goals.

The key findings of this study were:

1. A total of 105 individuals with chronic limb-threatening ischemia who had a median age of 70 years were included. 33 (31.4%) of the patients were female, and 45 (42.8%) were Black, Hispanic, or Latino.

2. 104 patients (99.0%) had transcatheter arterialization of the deep veins successfully completed.

3. At six months, 66.1% of the patients had avoided amputation.

4. The posterior chance that amputation-free survival at 6 months met a performance target of 54%, according to Bayesian analysis, was 0.993, exceeding the predetermined barrier of 0.977.

5. 67 people had their limbs saved. 16 of 63 patients' wounds were fully healed (25%) and 32 of 63 patients' wounds were healing (51%).

6. There were no unforeseen negative device-related incidents recorded.

Reference:

Shishehbor, M. H., Powell, R. J., Montero-Baker, M. F., Dua, A., Martínez-Trabal, J. L., Bunte, M. C., Lee, A. C., Mugglin, A. S., Mills, J. L., Farber, A., & Clair, D. G. (2023). Transcatheter Arterialization of Deep Veins in Chronic Limb-Threatening Ischemia. In New England Journal of Medicine (Vol. 388, Issue 13, pp. 1171–1180). Massachusetts Medical Society. https://doi.org/10.1056/nejmoa2212754

The New England Journal of MedicineTranscatheter arterializationchronic limb-threatening ischemiaEndovascular revascularization
Source : The New England Journal of Medicine
Jacinthlyn Sylvia
Jacinthlyn Sylvia

    Neuroscience Masters graduate

    Jacinthlyn Sylvia, a Neuroscience Master's graduate from Chennai has worked extensively in deciphering the neurobiology of cognition and motor control in aging. She also has spread-out exposure to Neurosurgery from her Bachelor’s. She is currently involved in active Neuro-Oncology research. She is an upcoming neuroscientist with a fiery passion for writing. Her news cover at Medical Dialogues feature recent discoveries and updates from the healthcare and biomedical research fields. She can be reached at editorial@medicaldialogues.in

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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