Peripheral Arterial Disease (PAD) is a condition that arises due to the narrowing of arteries in the limbs resulting in insufficient blood supply, commonly affecting the lower extremities. Chronic Limb Ischemia (CLI) is a severe form of PAD that occurs when there isn’t enough blood supply to meet the demand for oxygen and nutrients in the affected regions, causing pain, skin ulcers, and even limb amputation in some cases. CLI is a leading cause of morbidity and mortality worldwide with a 5-year survival rate of only 50%. For patients with end-stage CLI or ‘no-options,’ invasive procedures such as bypass surgery and angioplasty may not be possible. Fortunately, there is a new alternative for these patients that may give some hope. In this article, we delve into the emerging treatment options for CLI that provide avenues for patients with limited options to receive treatment and improve their quality of life.
The results of the PROMISE II trial have shown that transcatheter arterialization of the deep veins could provide a new option for those with severe critical limb ischemia (CLI) at risk for amputation. In the study, which included 105 participants with “no-option” CLI and Rutherford class 5 or 6, a novel system (LimFlow) was used to divert arterial flow from the tibial artery to the tibial veins. Technical success was achieved in 99% of procedures and the primary endpoint of amputation-free survival at 6 months was met in 66% of patients. Limb salvage was attained in 67 patients (76% by Kaplan-Meier analysis). Wounds were completely healed in 25% of participants and were in the process of healing in 51% of participants. Mehdi H. Shishehbor, DO, MPH, PhD, president of University Hospitals Harrington Heart & Vascular Institute, Cleveland, who spoke about the study, said that although amputation should be a last resort, for many CLI patients there are no options, and the only choice is indeed amputation. However, LimFlow offers new hope to those who would otherwise have had no further options for treatment. As African-American and Hispanic patients are four times as likely to undergo amputation and four times less likely to undergo revascularization, it is hoped that this procedure will help to reduce disparities and provide another way to combat serious CLI. The next step is to gain FDA approval for the procedure’s use in the US, and to establish a new research project, PROMISE III, a registry of 25 sites in the United States which will enrol around 200 patients.
In conclusion, for patients with severe CLI who have exhausted all other treatment options, TCAR may be a viable alternative. This minimally invasive procedure offers a quicker recovery time and has shown promising results in improving blood flow and reducing the risk of amputation. While TCAR may not be suitable for every patient, it is an exciting development in the field of vascular surgery and offers hope for those who previously had no options. If you or a loved one is struggling with severe CLI, be sure to speak with a qualified vascular surgeon to determine if TCAR may be the right option for you.
