PURPOSE:Patients with pedal artery occlusive disease have limited options when presenting with chronic limb-threatening ischemia (CLTI). Serration angioplasty (SA) has demonstrated less recoil and improved freedom from reintervention compared with plain old balloon angioplasty within the tibial vessels. We aimed to identify the technical feasibility and clinical outcomes of SA within the pedal (inframalleolar) vasculature in patients with CLTI. MATERIALS AND METHODS:Patient with SA of the pedal vasculature for CLTI from January 01, 2021 to March 31, 2023 were included in this multicenter retrospective study. Pedal vessels were defined as any inframalleolar vessel distal to the talocrural joint. Patient demographics, anatomic and technical details, acute procedural outcomes, and outcomes at the most recent follow-up were collected for analysis. The primary endpoint was technical success, defined as SA with <50% residual target vessel stenosis. Secondary endpoints included freedom from vessel injury, amputation-free survival, clinically-driven target lesion revascularization (CD-TLR), composite major adverse limb events (MALEs), wound healing rate, and improvement in wound, ischemia, and foot infection (WIfI) clinical stage at the most recent follow-up. RESULTS:Of the identified 45 patients managed with pedal SA, median pre-intervention Rutherford classification was 5, and 91.9% of patients had concomitant below-the-knee tibial artery intervention. The most commonly treated artery was the dorsalis pedis (59.2%), with a median diameter SA of 2.5 mm. Residual stenosis was <50% in 93.3% of cases and <30% in 82.2%. Freedom from vessel injury was 93.3% (1 immediate occlusion and 2 bail-out stents). Six-month freedom from major amputation was 93.3%, freedom from pedal CD-TLR was 93.3%, and freedom from MALE was 80.0%. At a median follow-up of 163 days, 48.7% of patients had complete wound healing, with the total frequency of either healed or improving wounds of 79.5%. CONCLUSION:Serration angioplasty of the inframalleolar vasculature in patients with CLTI had high rates of technical success with a low incidence of vessel injury. At a median follow-up of 5.4 months, wound healing was ahead of previously published studies on inframalleolar intervention.Clinical ImpactThis represents the largest series of a specialty balloon used to treat pedal occlusive disease in chronic limb-threatening ischemia patients. As the rate of pedal intervention increases, using new technology to safely achieve luminal gain is crucial for both short- and long-term limb salvage.

Objective Transcatheter arterialization of the deep veins (TADV) is an emerging option for patients with no-option chronic limb-threatening ischemia (CLTI). While promising for limb salvage, predictors of outcomes remain undefined. Medial arterial calcification (MAC) is common in this population and may influence procedural success and healing, but its role in the TADV setting is not well established. We aimed to evaluate the clinical outcomes of TADV in no-option CLTI patients and explore the utility of preoperative pedal MAC scores. Methods A retrospective analysis of 28 patients (30 limbs) with no-option CLTI who underwent TADV between 2020 and 2024 across two tertiary centers was done. Preoperative MAC burden was quantified using foot X-rays and categorized as MAC > 3 vs. MAC ≤ 3. Primary outcomes included limb salvage and overall survival; secondary outcomes included wound healing, minor amputations, and length of hospital stay. Kaplan-Meier analyses were used to estimate survival and stratify outcomes by MAC burden. Results Mean age was 63.1 ± 12.3 years; 75% were male, 92.9% had diabetes, and 75% had chronic kidney disease. The median baseline MAC score was 4.0 (IQR 3.0–5.0), with 53.3% of limbs classified as MAC > 3. At 6 months, limb salvage and amputation-free survival were 86.5% and 81.1%, respectively. Over half of the limbs achieved complete wound healing. Patients with MAC > 3 had numerically higher 6-month limb salvage (90.9% vs. 82.5%) and survival (100% vs. 91.7%) compared to MAC ≤ 3, though differences were not statistically significant. Conclusions TADV may be a viable limb salvage strategy for patients with no-option CLTI, achieving high wound healing and survival rates despite advanced comorbid burden and MAC scores. MAC scoring may assist in risk stratification, but larger prospective studies are needed to validate its prognostic utility in TADV-treated patients.

OBJECTIVE:The purpose of this study was to report on the outcomes of patients treated with the LimFlow System for transcatheter arterialization of the deep veins (TADV) in a real-world setting, after its approval from the U.S. Food and Drug Administration and subsequent commercialization. METHODS:This multicenter, observational, retrospective analysis included patients who were treated with the LimFlow System for TADV from October 2023 to August 2025. Study outcomes included amputation-free survival (AFS) (a composite of freedom from both major above-ankle amputation and all-cause mortality), limb salvage (freedom from major above-ankle amputation), survival (freedom from all-cause mortality), wound healing status (worsening, stable, improving, or healed), and patency of the stent graft through follow-up. RESULTS:A total of 80 patients were included in the analysis. Technical success of the TADV procedure was 100%. The median follow-up after TADV was 184 days (interquartile range, 78-357 days). The AFS rate was 74.2% at 6 months and 63.6% at 1 year. The limb salvage rate was 76.1% at 6 months and 71.7% at 1 year. The overall survival rate was 93.1% at 6 months and 84.7% at 1 year. Wounds were healed, stable, or improving in 94.3% of patients at follow-up. Graft patency was maintained in 75.4% of patients at 3 months and 60.3% at 6 months. CONCLUSIONS:In this first real-world, multicenter, retrospective study, TADV with the LimFlow System demonstrated favorable AFS and limb salvage outcomes.

Deep vein arterialization (DVA) has emerged as a technique for limb salvage in patients with chronic limb-threatening ischemia who lack distal arterial targets for conventional revascularization. Multiple operative strategies to perform DVA exist, all involving creation of an arteriovenous (AV) connection between a tibial artery and its corresponding vein. While technical success rates range from 79% to 100%, procedural challenges remain, most notably the creation of the AV connection. We present a novel crossing strategy designed to facilitate AV connection formation during DVA using the LimFlow system (Stryker).

Our objective was to evaluate risk factors for re-infection in patients after treatment for diabetic foot osteomyelitis (OM). We used pooled patient level data from two RTCs that evaluated patients with diabetic foot infections. We evaluated 171 patients with OM. OM was confirmed with bone culture or histopathology. Data from the 12-month follow-up were used to determine clinical outcomes. Re-infection occurred in 47 (27.5%) patients. Risk factors for re-infection were Toe Brachial Index <0.40 (25.7% vs. 9.8%, p = 0.02), skin perfusion pressure <40 mmHg (6.3% vs. 5.9%, p = 0.04), wound healing (55.3% vs. 75.0%, p = 0.01), time to heal (156.0, 69.5-365 vs. 91.5, 38.8-365, p = 0.001), and history of MI (14.9% vs. 3.2%, p = 0.005). During 12-month follow-up, patients with re-infections were 198.8 times more likely to require a foot related hospitalisation (81.8% vs. 0.0%, p = 0.001), 10.4 times more likely have an all-cause hospitalisation (70.2% vs. 18.5%, p = 0.001) and 9.4 times more likely to need an amputation (36.2% vs. 5.6%, p = 0.001). Patients with re-infection had a significantly longer median length of hospitalisation (20.0, 13.5-34.5 vs. 14.0, 10.0-22.0, p = 0.003) and median length of antibiotic duration (55.0, 35.0-87.0 vs. 46.0, 22.8-68.0, p = 0.03). Patients with re-infection are less likely to heal and have more foot-related hospitalizations and amputations.

Our objective was to assess the incidence, risk factors and clinical outcomes of dehiscence after foot surgery in diabetic patients. We used pooled patient-level data from two randomised clinical trials with 240 diabetic patients who required foot surgery for infections. Most patients (n = 180, 75.0%) had surgical wound closure. We defined dehisced surgical wounds (DSW) when the surgical site was not completely epithelialized with no drainage after sutures/staples were removed with a 2-week validation of healing. We evaluated the time to heal, re-infection, re-ulceration, hospital admissions and amputations. Moderate and severe infection was based on criteria of the International Working Group on the Diabetic Foot. We used χ2 and t-test and Mann-Whitney U for comparison of clinical events, with α of <0.05. DSW occurred in 137 (76.1%) patients. DSW patients were more likely to have hypertension (62.8% vs. 81.8%, p = 0.01), high ESR (59.1 ± 37.9 vs. 75.9 ± 37.6, p = 0.01), low toe brachial indices (0.8 ± 0.2) (0.7 ± 0.2, p = 0.005), toe brachial indices <0.6 (16.7% vs. 40.9%, p = 0.008), and low skin perfusion pressure measurements (dorsal medial 71.0 ± 29.4 vs. 59.3 ± 23.3, p = 0.01, and plantar medial 81.8 ± 24.9 vs. 72.2 ± 20.4, p = 0.02). During 12-month follow-up, DSW patients were 12.9 times more likely to have re-infection (0% vs. 12.4%, p = 0.02) and 6.8 times more likely to require amputation (2.3% vs. 13.9%, p = 0.04). The median healing time (28, 22.5-35.0 vs. 114.0, 69.0; 365, p = 0.001), and median length of hospitalisation were longer in DSW patients (12.0, 9.01-9.0 vs. 15.0, 11.0-24.0, p = 0.04). There was a high incidence of DSW, associated with poor clinical outcomes.

Background:After venous stent placement, patients may develop in-stent thrombosis (IST). The RevCore thrombectomy catheter (Inari Medical) is a novel device specifically designed to treat venous IST. Herein, the safety and feasibility of this device are evaluated. Methods:Patients were retrospectively included if they were ≥18 years old, had lower extremity venous IST, and were treated using the study device. The primary end point is technical success, defined as an average postprocedural effective diameter ≥50% and calculated using stent diameter and flow channel diameter on intravascular ultrasound. The safety end points are 30-day device-related serious adverse events, namely mortality, readmission, clinically significant pulmonary embolism, and vessel perforation. Results:Data from 44 patients (48 treated limbs, 6 treated stent types) from 4 centers were analyzed. Mean age was 54.8 ± 17.1 years, and 23 (52.3%) patients were female. Median IST symptom duration was 8.0 (IQR, 2.0-104.0) weeks. The primary end point was achieved in all 48 limbs. Comparing baseline with postprocedural measurements, effective stent diameter increased from 21.1% ± 26.5% to 89.6% ± 10.1%. No patient met a safety end point. On the first follow-up at 40.0 (29.0-62.5) days, primary patency was demonstrated in 32 (94.1%) of the 34 treated limbs with available data. Six (85.7%) limbs with Clinical-Etiology-Anatomy-Pathophysiology scores of C6 at baseline had longer-term data available (3.1 ± 0.7 months), and all limbs demonstrated improvement of C6 disease, with 3 (50.0%) improving to class C5. Conclusions:A thrombectomy procedure for deep-vein IST reestablished patency in all cases and across multiple stent types. Patency was sustained through the first follow-up in 94% of limbs.

Objective: Protective garments are part of the routine radiation safety equipment used during fluoroscopically guided interventions (FGIs). New elements and lead equivalences have been introduced by manufacturers, which may influence protection for interventionalists from ionizing radiation. We sought to determine the performance of different lead-equivalent apron vests during FGIs in clinical and simulated scenarios. Methods: Our primary endpoint was to evaluate the effectiveness of radiation dose attenuation of two different protective leaded apron vests, one with nominal 0.5-mm lead equivalence and a second with 0.35-mm lead equivalence, which were evaluated in clinical and simulated settings. In the clinical setting, optically stimulated luminescence nanoDotTM detectors were placed at the upper outer quadrant (UOQ) chest wall (CW) position, both over and under the apron vests on one vascular surgeon performing FGIs over a 21-month period. All interventions were performed in hybrid rooms with Allura Clarity (Phillips Healthcare) C-arms with state of-the-art software for vessel navigation, digital subtraction angiography, digital magnification, and collimation. Dosimeters were placed on either side of the primary operator's body, located on the side closest to the X-ray source. In the simulation, fluorography was performed on a 30-inch-thick acrylic scatter phantom at 68, 80, 100, and 120 kVp for an exposure of 2000 mGy reference air kerma. Experiments were performed on the 0.35-mm and 0.5-mm lead-equivalent aprons. Paired Wilcoxon, X-2, and analysis of variance tests were performed to identify statistical significance of radiation attenuation dose rates. Results: Operator UOQ CW radiation dose was measured during 32 FGIs: 16 were performed with the 0.5-mm lead-equivalent apron and 16 with the 0.35-mm lead-equivalent apron. Median procedure reference air kerma was 167 mGy (interquartile range, 99-437 mGy) when the 0.5-mm apron vest was worn vs 250 mGy (interquartile range, 144-410 mGy) with the 0.35-mm vest. There was no significant difference in UOQ CW radiation dose attenuation between the two lead equivalencies: thick 89% vs thin 86%; P = .2. In the simulated scenario, radiation dose attenuation was similar for all measured kVp, with no significant differences for both apron vests (94% thick vs 95% thin; P = .49). Conclusions: Heavier leaded aprons do not offer clinically significant increased protection over thinner lead. Due to the long-term musculoskeletal strain on interventionalists, it is safe to consider lightweight lead protection. (JVS-Vascular Insights 2025;3:100154.)

In recent years, deep venous stenting has increasingly become a treatment strategy for post-thrombotic syndrome. Stent thrombosis can occur, resulting in symptom recurrence despite medical therapy and there are few options available for durable stent patency restoration. We present a case of a 50-year-old male with prior iliocaval reconstruction that experienced recurrent left lower extremity swelling secondary to occlusion of left external iliac and common iliac vein stents during follow-up. Mechanical thrombectomy with the RevCore System and angioplasty was performed. One month later, the patient demonstrated widely patent bilateral iliac vein stents and complete symptomatic resolution. The RevCore System is a feasible alternative for treatment of chronic in-stent thrombosis.

The objective of the study was to compare outcomes in patients with complete surgical resection versus partial resection of diabetic foot osteomyelitis (OM). A post hoc analysis of 171 patients with OM was performed using data from two randomized clinical trials. OM was confirmed with bone culture or histopathology. Surgical culture specimens were obtained from resected bone and sent for histopathology and microbiology. Residual osteomyelitis (RO) was defined as a positive resected margin on culture or histopathology. No residual osteomyelitis (NRO) was defined as no growth from bone culture and no histopathological inflammation in the biopsy of the resection margin. Data from the 12-month follow-up were used to determine clinical outcomes. During the index hospitalization, NRO patients had significantly shorter duration of antibiotic therapy (NRO 21.0, 13.0-38.0 vs. RO 37.0, 20.8-50.0, p <0.01) and more amputations than patients with RO (NRO 89.9% vs. RO 60.9%, p <0.01). During the 12-month follow-up, patients with NRO also had significantly shorter duration of antibiotic therapy (NRO 42, 21.0-66.5 vs. RO 50.5, 35.0-75.0, p = 0.02). During the 12-month follow-up, there was no difference in ulceration at the same site (NRO 3.7%, RO 4.3% p = 0.85), hospitalization (NRO 32.6%, RO 34.8%, p = 0.76), total re-infections (NRO 25.3%, RO 29.3%, p = 0.56), re-infection with osteomyelitis (NRO 13.3% vs. 13.5%, p = 0.36), amputation (NRO 8.8%, RO 5.4%, p = 0.86) and time to wound healing in days (NRO 94, 41.0-365 vs. RO 106, 42.8-365, p = 0.77). Successful treatment of osteomyelitis was achieved by 86.7% and 86.5% of patients. During the index hospitalization, patients with no residual osteomyelitis had more amputations and were treated with antibiotics for a shorter duration. During the 12-month follow-up, patients with no residual osteomyelitis had shorter durations of antibiotics. There were no differences in re-infection, amputation, re-ulceration or hospitalization. Level of evidence: 1.

BACKGROUND:Below-the-knee (BTK) lesions may be particularly challenging to treat owing to length, diffuse disease, and extent of calcification. Landmark interventional clinical studies have not reached consensus on the optimal standard of care for BTK lesions, and many published trials excluded patients with moderate or severe lesion calcification. Calcium modification with intravascular lithotripsy (IVL) was shown to be superior to percutaneous transluminal angioplasty in the femoropopliteal artery and successful in treating BTK lesions in pilot studies. The Disrupt BTK II study is a core laboratory-adjudicated, prospective, multicenter, single-arm study of patients with moderate to severely calcified BTK lesions treated with the Shockwave Medical Peripheral IVL System. METHODS:Disrupt BTK II enrolled 250 subjects with calcified infrapopliteal lesions and Rutherford category 3-5 presentation from 38 sites in the United States and Europe. The primary safety endpoint was major adverse limb events or postoperative death at 30 days, a composite of all-cause death, above-ankle amputation of the index limb, and/or major reintervention of the index limb involving an infrapopliteal artery. The primary effectiveness endpoint was procedural success, defined as ≤50% residual stenosis for all treated target lesions without serious core laboratory-adjudicated serious angiographic complications. The study used independent angiographic and duplex ultrasound core laboratories, and follow-up is planned through 2 years. RESULTS:A total of 305 lesions in 250 patients were treated with a procedural success of 97.9%. The mean target lesion length was 76 ± 65 mm, diameter stenosis was 78% ± 18%, and 84.8% had moderate or severe calcification as assessed by an independent angiographic core laboratory. After IVL, residual stenosis was reduced to 29%, and after optional postdilatation and/or stent implantation, to 26%. At 30 days, there were no deaths, major adverse limb event rate was 0.8%, and mean improvement in Vascular Quality of Life scores was 4.0 ± 5.0 (P < .0001). Of the patients with baseline wounds, 15.8% healed and 53.4% were improved at 30 days. CONCLUSIONS:The Disrupt PAD BTK II study demonstrated that treatment with the Shockwave Medical Peripheral IVL System in patients with moderate-severe calcified lesions resulted in high procedural success, significant reduction in residual stenosis, improvements in patient quality of life, and wound healing, with minimal adverse events at 30-day follow-up.

The aim of this study was to compare the microbial loads of patients with diabetic foot infections treated with negative pressure wound therapy (NPWT) with and without irrigation with polyhexamethylene biguanide (NPWTi-P). This is a post hoc analysis of combined data of two randomized clinical trials. We evaluated people with diabetes treated with moderate and severe diabetic foot infections that required surgery. Tissue specimens were obtained after the initial surgery and following a second planned return to the operating room after 48-72 h of NPWT or NPWTi-P, prior to the second surgery. We used quantitative polymerase chain reaction (qPCR) to determine the total microbial loads (Log10 16S copies per gram of tissue). There was no difference in mean quantitative bacterial cultures among patients that received NPWT and NPWTi-P (before first surgery Log10: NPWT = 6.4 ± 1.8, NPWTi-P = 7.5 ± 1.7 vs before second surgery Log10: NPWT = 6.7 ± 1.8, NPWTi-P = 7.6 ± 1.9 p = .12). There was no difference in wound healing (59.5% vs 50.0%, p = .51) or time to heal (127 ± 109.3 vs 143 ± 95.9), p = .71). There were fewer re-infections in people that received traditional NPWT (28.6% vs 56.3%, p = .05).Level of Clinical Evidence: Level 1.

To identify the incidence of methicillin-resistant Staphylococcus aureus (MRSA) infection, reinfection and clinical outcomes. Four hundred forty-six patients that were admitted to the hospital with moderate or severe foot infections were retrospectively reviewed. Tissue and bone cultures were obtained from the index hospital admission. Conversion was defined as methicillin susceptible Staphylococcus aureus in the first culture and subsequently MRSA when there was a reinfection. The incidence of MRSA was 7.8% (n = 35), with no significant difference between soft tissue infections (7.7%) and osteomyelitis (8.0%). MRSA incidence was 9.4 times higher in non-diabetics (23.8% vs. 3.2%, p = <0.01). The incidence of reinfection was 40.8% (n = 182). Conversion to MRSA was seen in 2.2% (n = 4) total, occurring in 5.4%. Non-diabetics were 20.1 times more likely to have MRSA reinfection than people with diabetes (28.6% vs. 1.9%, p < 0.001). MRSA patients had a higher proportion of healed wounds (82.4% vs. 69.3%, p = 0.02). There were no differences in other clinical outcomes in MRSA vs. other infections in reinfection (28.6% vs. 24.3%, p = 0.11), amputation (48.6% vs. 52.0%, p = 0.69) or hospitalization (28.6% vs. 42.6, p = 0.11). The incidence of MRSA for the first infection (7.8%), reinfection (6.0%) and conversion to MRSA (2.2%) was low. MRSA was 9.4 times more common in people without diabetes.