Transcatheter Arterialization for Limb Ischemia
- All patients had chronic limb-threatening ischemia with gangrene and no options for arterial revascularization.
- Amputation-free survival at 5 months compared favorably to historical controls (66.1%). Procedural technical success was 99%, and no device-related adverse events were reported.
Does transcatheter arterialization of deep veins in patients with chronic limb-threatening ischemia (CLTI) improve amputation-free survival among patients without surgical or endovascular arterial revascularization options?
This prospective, single-group multicenter study evaluated the effect of transcatheter arterialization of the deep veins in patients with CLTI, nonhealing ulcers, and lack of arterial revascularization options. No-option status was defined as either: 1) absence of a pedal artery target for endovascular or surgical therapy, or 2) absence of a viable single segment of autogenous vein conduit despite the presence of a pedal artery target that could receive a graft. Patients with Rutherford class 5 (tissue loss or focal gangrene) or 6 (extensive gangrene) due to CLTI were eligible. The primary endpoint was amputation-free survival, defined as a composite of freedom from above-ankle amputation or death from any cause at 6 months. Secondary endpoints included limb salvage, wound healing, and technical success. Post-revascularization pharmacotherapy consisted of either dual antiplatelet therapy or anticoagulation and was not assigned within the study protocol.
A total of 105 patients were enrolled, and 104 (99%) had a technically successful procedure. Amputation-free survival was 66.1% at 6 months, and limb salvage was obtained in 67 patients (67% by Kaplan-Meier analysis). Wounds completely healed in 16/63 patients. No anticipated device-related events were reported.
Transcatheter arterialization of the deep veins was safe and could be performed successfully in patients with CLTI and no conventional surgical or endovascular revascularization treatment options.
The design of the current study was unusual relative to many peripheral artery disease device trials because the inclusion criteria for this study resemble the exclusion criteria for most others. All participants had severe CLTI with gangrene (Rutherford class 5 or 6), and patients with dialysis-dependent chronic kidney disease were also eligible as long as they had autogenous access or were receiving peritoneal dialysis. The authors should be commended for this approach, which supports generalization of the findings to real-world practice.
Deep vein arterialization procedures utilized devices specifically designed for this purpose, including a reentry device and a “push” valvulotome. The paper includes figures with intraoperative images and diagrams that are worth a review for readers interested in this technique.
Limitations of this study were it was unblinded and lacked a control intervention. It is therefore possible that enrollment may have biased both participants and clinicians toward more conservative criteria for considering amputation during the study period. Because the results suggest that deep vein arterialization offers improved amputation-free survival, however, a placebo-controlled randomized study would present challenges from both recruitment and ethical perspectives. Although the improvement in amputation-free survival was modest versus historical controls, it is probable that most “no options” patients might have justified reservations about being randomized to a control intervention.
Mortality among patients undergoing amputation for CLTI is highlighted within the current study’s introduction, but death among patients with CLTI (regardless of whether they undergo amputation) is most commonly caused by stroke or coronary heart disease (rather than limb-related causes). Although revascularization procedures for CLTI therefore do not usually offer much potential to improve survival, they nonetheless alleviate suffering due to rest pain, wounds, or gangrene and may prevent (or delay) amputation. The goal of revascularization therefore is to improve quality (if not quantity) of life. New techniques that create revascularization opportunities for patients who were previously in the “no options” category are therefore a welcome ray of hope for these patients and the vascular specialists who treat them.
Clinical Topics: Anticoagulation Management, Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Prevention, Vascular Medicine, Atherosclerotic Disease (CAD/PAD), Aortic Surgery, Cardiac Surgery and Arrhythmias, Interventions and Vascular Medicine
Keywords: Amputation, Anticoagulants, Endovascular Procedures, Gangrene, Ischemia, Myocardial Revascularization, Peripheral Arterial Disease, Quality of Life, Secondary Prevention, Ulcer, Vascular Diseases
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