8.3 BEST Approaches to Revascularization in Critical Limb Ischemia: Interventional or Surgical?

These proceedings summarize the educational activity of the 17th Biennial Meeting of the International Andreas Gruentzig Society held January 30 to February 2, 2024 in Chiang Rai, Thailand.

Faculty Disclosures     Vendor Acknowledgments

2024 IAGS Summary Document

Statement of the problem or issue

Therapies for patients with peripheral arterial disease (PAD) and critical limb ischemia (CLI) have not advanced as much as they have for coronary and structural heart diseases. We are far behind in the PAD area. There is too much primary amputation performed for CLI, without adequate evaluation or consideration for revascularization which could salvage 90% of the limbs. The 1-year mortality after major amputation is 40%. Some background is shown in Table 1.

Table 1. Background for Peripheral Arterial Disease and Critical Limb Ischemia.

CLI = critical limb ischemia.

One of the greatest impediments is interventional treatment of claudication due to PAD; it is not covered at all or is not covered adequately by insurance plans. Can you imagine what it would be like if a woman came into the office and was found to have Stage 1 breast cancer, and she was told “Sorry, we can’t treat you. Not sick enough. Come back when you have Stage 4 breast cancer, and we can treat you then.”

Table 2. Aspects of Problems in Peripheral Arterial Disease and Critical Limb Ischemia.

Gaps in current knowledge

We do not know what treatment is best for which patients with PAD and CLI. There were two randomized trials published within the past year that were supposed to provide insight into this issue. These were the BEST-CLI trial, published in the New England Journal of Medicine, and the BASIL-2 trial, published in Lancet.^1,2 Unfortunately, the way the trials were conducted, using different populations and different primary endpoints, and the fact they reached diametrically opposite conclusions, makes them extremely difficult or impossible to interpret and apply practically. These trials have not answered any questions or solved any problems, they have only created more.

Possible solutions and future directions

We should create dedicated CLI centers of excellence to address some of these problems. We need more rigorous physician training and education. Current fellowships do not adequately address CLI. We should somehow incorporate artificial intelligence into wound healing therapies. Wound treatment is completely non-standardized and haphazard. Further, I would like to see more interdisciplinary cooperation, but that may be difficult to achieve with turf wars so common. The endovascular-oriented societies should take a stronger stance in this. Current interventional cardiology fellows have strong preferences for structural heart training, and not for peripheral arterial system training. They also tend to concentrate on coronary artery disease (Table 3).

Table 3. Possible solutions and future directions.

References

1. Farber A, Menard MT, Conte MS, et al. Surgery or endovascular therapy for chronic limb-threatening ischemia. N Engl J Med. 2022;387(25):2305-2316. doi: 10.1056/NEJMoa2207899. PMID: 36342173.
2. Bradbury AW, Moakes CA, Popplewell M, et al. A vein bypass first versus a best endovascular treatment first revascularisation strategy for patients with chronic limb threatening ischaemia who required an infra-popliteal, with or without an additional more proximal infra-inguinal revascularisation procedure to restore limb perfusion (BASIL-2): an open-label, randomised, multicentre, phase 3 trial. Lancet. 2023;401(10390):1798-1809. doi: 10.1016/S0140-6736(23)00462-2. PMID: 37116524.