Figura 1. Lower limb arteriography. A) Left superficial femoral artery chronic occlusion with signif...

Figura 2. Comparison of the ankle-brachial index (ABI), before and after the procedure: A) alluvial ...

Tabla 1. Baseline characteristics of the study sample.

Tabla 2. Percutaneous management, short- and long-term outcomes.

Figura 3. Evolution of ischemic lesions.

Introduction

Critical limb ischemia (CLI) constitutes the most advanced stage of peripheral arterial disease, characterized by severe arterial obstruction in the lower limbs, with a high impact on quality of life and an elevated rate of morbidity and mortality1. This condition, marked by rest pain and ischemic lesions, poses a therapeutic challenge. Chronic total occlusions (CTO) are defined as those with ischemic pain at rest (Leriche-Fontaine classification type III)2, or critical ischemia with ulcers or gangrene (type IV). CTOs are often found in CLI, with a frequency of up to 40% in patients with symptomatic peripheral arterial disease. The complex nature of CTOs, especially in the case of long lesions and severe calcification, can negatively affect immediate and medium-term outcomes after endovascular treatment.

Angioplasty or endovascular revascularization has emerged as a safe and effective alternative, notable for being less invasive and less risky compared with open vascular surgery3. However, CLI is often associated with multilevel disease and severe calcification, which requires a combined strategy addressing both inflow (aortoiliac and femoral) and outflow (tibial)4. While much of the evidence on endovascular treatment of inflow derives from studies focused on claudication, specific results in patients with CLI are limited1. Angioplasty, which can be performed either endoluminally5 or through percutaneous intentional extraluminal recanalization (PIER), offers a viable option, but long-term outcomes in this population remain uncertain6. The following study seeks to describe the efficacy and safety of angioplasty in the treatment of superficial femoral artery CTO.

Materials and methods

Study design

This is an observational, descriptive, longitudinal, retrospective retrieval study, with a single-arm historical cohort. Its design adhered to the recommendations of the STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) initiative7. It was conducted in patients diagnosed with superficial femoral artery chronic total occlusion, treated at a referral center in the Autonomous City of Buenos Aires during the period from January 2022 to December 2023. The research protocol adhered to the 2008 Declaration of Helsinki and was approved by the institutional ethics committee8.

Selection criteria

The study included patients over 18 years of age, diagnosed with CLI, with a pre-procedure CTO (type III or IV according to the Leriche-Fontaine scale)2, who underwent angioplasty. Patients with non-atherosclerotic occlusion (thrombosis, dissection, or embolism) were not considered for this study. Patients whose medical records lacked the necessary information for the purposes of this study were also excluded.

Procedure and technique

An anterograde puncture was performed with a 0.35 hydrophilic wire, supported through a 4 or 5-Fr vertebral catheter. Once the wire was successfully advanced, the catheter followed. Operators used peripheral rotational atherectomy device JetstreamTM (Boston Scientific; Natick, Massachusetts, USA) with an infusion and continuous aspiration system, with self-expanding blades (Figure 1). The infusion and continuous aspiration system helped minimize the risk of distal embolization. The self-expanding blade system was designed to provide concentric and larger-diameter lumens. Confirmation was obtained through angiography. The balloon or prosthesis was advanced using a wire placed over where the catheter was9.

Management of complications. In the case of a dissection as a possible adverse event, it was resolved using a self-expanding EpicTM Vascular prosthesis (Boston Scientific; Natick, Massachusetts, USA). In the case of recoil, this was resolved using a semi-compliant balloon catheter system.

Short- and long-term outcomes

Short-term outcomes consisted of technical success rate, clinical success rate, and procedure-related adverse events. Clinical success was defined as the identification of a femoral artery with adequate flow and improvement in the ankle-brachial index (ABI), with resolution of symptoms and wound healing. Long-term outcomes consisted of patency at six months after the procedure and reintervention rate.

Statistical analysis

Technical considerations. A p-value < 0.05 was considered statistically significant. The statistical analysis was conducted using R (R Foundation for Statistical Computing; Vienna, Austria).

Sample size calculation. Considering an intermediate effect size (h=0.6), 42 observations (patients) were estimated as the minimum required for a repeated-measures comparison to contrast pre- vs. post-procedure ABI with a significance level of 95% and a statistical power of 80%.

Descriptive and inferential statistics. Continuous variables were described using the median and expressed in interquartile range (IQR). Categorical variables were described in percentages. Pre- vs. post-procedure ABI was contrasted using the Wilcoxon test and illustrated with an alluvial diagram.

Results

Table 1 summarizes the baseline characteristics of the study sample. Forty-two patients were selected, with a median age of 68 years (IQR: 65–72), 16 of whom were women (38.1%). Regarding their comorbidities, 33 had diabetes mellitus (78.6%), 29 had arterial hypertension (69%), and 26 had dyslipidemia (61.9%). Leriche-Fontaine grade III was estimated in 32 patients (76.2%) and grade IV in 10 patients (23.8%). Occlusion length was >10 cm in the entire sample, with a median of 13 cm (IQR: 10-15). High calcium content was identified in 31 patients (73.8%). The pre-procedure ABI was < 0.9 in all cases.

The subintimal technique was used in 33 patients (78.6%) and the endoluminal technique in 9 (21.4%); 33 patients (78.6%) required the placement of an endoluminal prosthesis. After angioplasty, all cases had an ABI of 0.9 to 1.0 (p < 0.001). Of the 28/42 patients with a post-procedure ABI of 1.0 (66.7%), 4/28 had a pre-procedure ABI of 0.5, 9/28 of 0.6, 14/28 of 0.7, and 1/28 of 0.8. Of the 14/42 patients with a post-procedure ABI of 0.9 (33.3%), 6/14 had a pre-procedure ABI of 0.5, 6/14 of 0.6, 1/14 of 0.7, and 1/14 of 0.8 (Figure 2).

Intra-procedure adverse events were documented in 28 patients (66.7%): 8/28 had dissections and 20/28 experienced recoil. Local hematomas were also documented in eight patients (19%), but there were no retroperitoneal hematomas. Patency at six months after the procedure was confirmed in 40 patients (95.2%) (Figure 3). Reintervention was required in only three patients, including two in whom patency was preserved (7.1%) (Table 2).

Discussion

The first attempt at subintimal angioplasty to treat CTOs in the femoropopliteal segment was in 1987, with technical success rates of 76% and an acceptable complication rate of 5.6%10. In general, the procedure uses the wire-and-catheter technique to approach the subintimal plane just above the CTO level5. A guidewire forming a loop is used to cross the occlusion in this low-resistance subintimal space to return to the true lumen of the artery beyond the occlusion. In a systematic review of 23 cohort studies including 1549 patients with CLI who underwent subintimal angioplasty for peripheral arterial occlusive disease, reported success rates and one-year limb salvage rates ranged between 80% and 90%. The study concluded that subintimal angioplasty plays an important role, especially in patients with chronic ischemia, in wound healing and limb salvaging11.

A recent Egyptian study compared angioplasty in 260 patients treated at the superficial femoral artery level versus 190 treated at the popliteal level, reporting overall technical success in 93.3% of cases. The technical success in superficial femoral artery lesions was 91.2%. The prevalence of vessels with no leak in patients treated at the superficial femoral artery level was 11.5%, contributing to a better technical success rate. However, technical success in the literature can reach up to 95.1% for subintimal angioplasty treatment of CTOs at the femoropopliteal level12.

In the case of CLI patients with severe symptoms who also present prohibitive surgical risk, poor runoff, or lack of a suitable autologous conduit, many medical societies consider angioplasty to be first-line therapy despite any anatomical limitations due to the disease13, 14. However, conventional transfemoral access during angioplasty of complex arterial lesions can be very challenging and may fail in up to 20% of cases15. Furthermore, there are different preferences when it comes to the antegrade versus retrograde approach; the antegrade approach is the most commonly used alternative. Nevertheless, one of the advantages attributed to retrograde access is that the distal occlusion cap is softer compared with the hard proximal fibrotic cap, so it can be more easily crossed with the retrograde wire. It also provides better wire pushability due to the proximity of the CTO to the retrograde access along with a lower likelihood that the retrograde wire will deviate into side branches originating in a craniocaudal direction.

It is important to emphasize that selective placement of endoluminal prostheses is more frequent for lesions in the superficial femoral artery than in the popliteal artery. Unlike the superficial femoral artery, the popliteal artery has a different embryology, as it originates from the sciatic system. Furthermore, while the superficial femoral artery and the tibial artery have an intramuscular course, the popliteal artery does not go through any muscle compartment. More importantly, the popliteal artery is exposed to enormous biomechanical forces due to frequent knee flexion and repetitive ankle movement. These distinctive properties of the popliteal artery can affect the outcomes of endovascular treatment options16. Consequently, acceptable concerns regarding vessel kinking, potential restenosis, and prosthesis fractures have led to the consideration that this vessel is not suitable for prosthesis placement.

The ideal outcome of revascularization in patients with peripheral arterial disease is complete relief of ischemic symptoms, particularly healing of ischemic wounds. Therefore, any assessment of these patients should consider wound healing and keeping the subjects wound-free17. Wound healing rates are significantly better when addressing the superficial femoral artery at three months (greater than 30%) and at one year (greater than 80%)18. Even with moderate long-term patency rates, one of the valuable outcomes of subintimal angioplasty in patients with CLI is that it assists wound healing and limb recovery, as supported by a large systematic review13.

This study has certain limitations. It was a retrospective, single-center, single-arm study focused on the management of the superficial femoral artery. The number of cases prevented any analysis of specific subgroups. A direct comparison with a group of patients whose pathology was managed conservatively or surgically was also impossible. Future studies should focus on describing the use of current techniques such as covered prostheses, drug-coated balloons, or re-entry devices. A future goal is to conduct a large-scale prospective multicenter study comparing subintimal angioplasty of CTOs using different types of prostheses, as well as comparing subintimal versus intraluminal angioplasty outcomes.

In conclusion, subintimal and endoluminal angioplasty are viable and effective revascularization techniques in the treatment of patients with CTO CLI at the superficial femoral artery. They offer high revascularization rates with low reintervention rates. Various authors have adopted angioplasty as the primary treatment in patients with CLI. These techniques should be considered the first-line treatment in patients with this disease, and surgical revascularization should be reserved to subjects in whom percutaneous procedures have failed.

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17. Cha JJ, Kim JY, Kim H, Ko YG, Choi D, Lee JH, et al. Long-term Clinical Outcomes and Prognostic Factors After Endovascular Treatment in Patients With Chronic Limb Threatening Ischemia. Korean Circ J [Internet]. 2022 Mar 1 [cited 2025 Jan 3];52(6):429. Available from: https://pmc.ncbi.nlm.nih.gov/articles/PMC9160641/.

18. Met R, Van Lienden KP, Koelemay MJW, Bipat S, Legemate DA, Reekers JA. Subintimal angioplasty for peripheral arterial occlusive disease: a systematic review. Cardiovasc Intervent Radiol [Internet]. 2008 Jul [cited 2025 Jan 4];31(4):687–97. Available from: https://pubmed.ncbi.nlm.nih.gov/18414946/.

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Subintimal and endoluminal angioplasty for chronic total occlusion of the superficial femoral artery: safety and efficacy described from a historical cohort

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