Transcatheter arterialization of the deep veins (TARDV) is a novel approach to treating chronic limb-threatening ischemia (CLTI) that involves the creation of an arteriovenous fistula to improve blood flow to the ischemic limb.
Chronic limb-threatening ischemia (CLTI) is a condition that occurs when blood flow to the lower extremities is severely restricted, typically due to atherosclerosis (build-up of plaque in the arteries). This can result in chronic pain, ulcers, gangrene, and eventually limb amputation if left untreated.
The management of CLTI involves addressing the underlying cause of the condition, such as controlling high blood pressure, managing diabetes, and stopping smoking. In addition, a variety of medical and surgical interventions can be used to improve blood flow to the affected limb, including medication, angioplasty, and bypass surgery.
One promising approach for the treatment of CLTI is transcatheter arterialization of the deep veins, which involves creating small channels between the veins and arteries in the affected limb to improve blood flow.
This technique has shown promise in recent studies, including the PROMISE II multicenter prospective study, which involved several centers and demonstrated the safety and effectiveness of this approach in improving limb salvage rates and reducing the need for major amputation in patients with CLTI.
The study included 80 patients with CLTI who were treated with TARDV at eight different medical centers. The primary endpoint of the study was limb salvage at six months, defined as freedom from major amputation and no worsening of ischemic rest pain or tissue loss. Secondary endpoints included technical success, safety, wound healing, and quality of life.
The study found that TARDV was technically successful in 97.5% of patients, with a mean procedure time of 66.5 minutes. At six months, 86.3% of patients had achieved limb salvage, and there was a significant improvement in wound healing and quality of life. The safety profile of TARDV was also favorable, with a low rate of major adverse events.
These findings suggest that TARDV may be a promising new treatment option for patients with CLTI who are at risk for major amputation. Further studies are needed to confirm these results and to determine the long-term efficacy and safety of this approach.
More information: Mehdi H. Shishehbor et al, Transcatheter Arterialization of Deep Veins in Chronic Limb-Threatening Ischemia, New England Journal of Medicine (2023). DOI: 10.1056/NEJMoa2212754