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., MartÃnez-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
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