Global Vascular Guidelines Research Articles

Clinical Outcomes After Distal Bypass in Patients With Chronic Limb-Threatening Ischemia due to Connective Tissue Disease.

Chronic limb-threatening ischemia (CLTI) is mostly caused by arteriosclerosis, but is sometimes due to connective tissue disease. However, there is a limited knowledge of clinical outcomes of patients with CLTI with connective tissue disease. The objective of the study was to assess outcomes after distal bypass in these patients using global vascular guidelines. Data from distal bypasses performed for CLTI at a single center from 2014 to 2023 were evaluated retrospectively. Clinical outcomes after distal bypass were compared for patients with CLTI with arteriosclerosis (AS group) and those with connective tissue disease (CD group). The primary endpoints were limb salvage and wound healing. Of the 282 distal bypasses performed for 222 patients with CLTI, 22 were conducted for 21 patients with connective tissue disease (CD group). The connective tissue disease was progressive systemic scleroderma (n = 11 patients), pemphigoid diseases (n = 2), polyarteritis nodosa (n = 2), rheumatoid arthritis (n = 2), and others (n = 4). Compared with the AS group, the CD group included more females (P = .007) and had greater oral steroid use (P < .001) and a higher Global Limb Anatomical Staging System (GLASS) inframalleolar (IM) modifier P2 (P < .001). The mean follow-up period of the whole cohort was 27 ± 22 months with no significant difference between the groups (P = .25), and 22 limbs required major amputation during this period. The 2-year limb salvage rate was significantly lower in the CD group compared to the AS group (75% vs 94%, P = .020). Wound healing was achieved in 220 (78%) limbs, and the 12-month wound healing rate was significantly lower in the CD group (52% vs 86%, P = .006). The low 2-year limb salvage and 12-month wound healing rates in patients with CLTI with connective tissue disease indicate that distal bypass may be challenging in these patients.

Evaluation of global vascular guidelines strategy in infra-inguinal occlusive disease: Revisited using global limb anatomic staging system.

Evaluation of global vascular guidelines strategy in infra-inguinal occlusive disease: Revisited using global limb anatomic staging system.

Prospective Multi-Center Longitudinal Study to Validate Accuracy of the Global Anatomic Staging System (GLASS) Score in Predicting Major Acute Limb Events in Patients With Chronic Limb Threatening Ischemia Undergoing Endovascular Intervention: The PROMOTE-GLASS Study Protocol.

Developed by the Global Vascular Guidelines committee, the Global Limb Anatomic Staging System (GLASS) is an angiographic scoring system used for quantifying infrainguinal disease extent and predicting treatment success with endovascular techniques (EVT). Currently, no other risk prediction model is available for patients with chronic limb threatening ischemia (CLTI) undergoing EVT. GLASS' validation and adoption outside academic institutions for research are limited. Thus, this longitudinal multicenter prospective study aims to examine GLASS' validity and reliability in predicting major acute limb events and overall survival (OS) in patients with CLTI undergoing EVT. This prospective, international, multicenter, observational study will include patients with CLTI undergoing EVT (PROMOTE-GLASS) (ClinicalTrials.gov; ID: NCT06186544) identified through routine clinical referrals and emergency visits to vascular units in participating centers. Only patients who are referred for EVT will be recruited. The primary outcomes are immediate technical success, immediate technical failure, and 1-year limb base patency. The secondary outcomes are major adverse limb events, major lower limb amputation, and OS in patients presenting with CLTI who undergo EVT up to 1 year after the procedure. Clinical and imaging data will be analyzed at the end of follow-up to validate risk prediction. This protocol outlines our approach for identifying cases, GLASS score calculation, outcome measures assessment, and a statistical analysis plan. PROMOTE-GLASS holds significant implications and can potentially revolutionize clinical decision-making by assisting clinicians in identifying patients who are likely to benefit from EVT. Ultimately, reduce the need for more invasive procedures and improve patient outcomes. Furthermore, PROMOTE-GLASS can provide useful information, including patient selection, for future randomized controlled trials (RCTs) investigating EVT for CLTI. PROMOTE-GLASS anticipated implications on the vascular community are rooted in its potential to improve patient care, inform future research, and address limitations in existing literature regarding CLTI treatment outcomes.

The impact of angiographic pedal circulation status on wound healing in chronic limb-threatening ischemia after bypass surgery

ObjectiveIn the treatment of chronic limb-threatening ischemia (CLTI), complete wound healing is an important goal. Although foot perfusion status seems to be important for wound healing, the Global Limb Anatomic Staging System (GLASS) of the Global Vascular Guidelines does not include pedal artery status for the staging process due to the lack of sufficient evidence of its importance. This study aimed to clarify the importance of pedal perfusion status after bypass surgery. MethodsAmong the 153 CLTI cases that underwent bypass distal to popliteal arteries from 2014 to 2018, 117 CLTI limbs with wounds and with sufficient pedal angiographic data were enrolled. They were classified into two groups, based on the wound status 6 months postoperatively; early wound healing group (EWG; n = 78), which achieved complete wound healing within 6 months postoperatively, and prolonged healing or unhealed wounds group (PWG; n = 39), which failed to achieve wound healing within 6 months. Various factors associated with wound healing, including the wound, ischemia, and foot infection (WIfI) classification, intraoperative graft flow, and pedal angiographic data, were analyzed. Regarding pedal angiographic data, in addition to the GLASS inframalleolar/pedal disease descriptor (IPD), newly formed classification system of the pedal circulation status in association with the location of wounds was included: pedal circulation status was classified into two groups as visualized arterial perfusion towards wounds (visualized perfusion) and non-visualized arterial perfusion towards wounds (non-visualized perfusion). ResultsUnivariate analysis showed preoperative albumin (Odds ratio [OR], 0.47; 95% confidence interval [CI], 0.24-0.94; P = .027), higher WIfI clinical stage (OR, 3.88; 95% CI, 1.74-10.1; P = .0005), higher IPD (OR, 2.16; 95% CI, 1.16-4.02; P = .012), and non-visualized perfusion to wounds (OR, 5.74: 95% CI, 2.45-14.0; P < .0001) as significant for prolonged wound healing. Multivariate analysis showed higher WIfI stage (OR, 5.04; 95% CI, 1.74-14.6; P = .0029) and non-visualized perfusion to wounds (OR, 4.34; 95% CI, 1.71-11.0; P = .0021) as significant, whereas IPD was not detected as significant. Regarding blood supply to the foot, although graft flow was significantly lower in IPD-P2 than IPD-P0/P1, graft flow was similar regardless of the status of angiographic circulation to wounds, suggesting that distribution of blood supply to the wound would be more important than total amount of blood supply to the foot for wound healing. ConclusionsWIfI clinical stage and pedal circulatory environment were important factors for wound healing after bypass surgery. Pedal anatomical classification system including perfusion status would be important for decision making in CLTI treatment.

Learning curve in tibial and pedal bypass with autologous vein graft.

The 2019 Global Vascular Guidelines recommended open bypass for patients at average risk with greater limb severity and anatomical complexity. However, the outcomes of tibial and pedal bypass (TPB) are inferior to those of above-the-knee surgical revascularization. This may be due to the technical difficulty and need for development of skills to perform TPB. However, there is a limited knowledge on the learning curve in TPB. Thus, the aim of the study is to assess this learning curve in a single-center retrospective analysis. Cases treated with TPB with an autologous vein conduit in patients with chronic limb-threatening ischemia (CLTI) at a Japanese single center from 2009 to 2022 were analyzed retrospectively. The primary endpoint was the learning curve for TPB. The study included 449 TPB procedures conducted by a single main surgeon in patients with CLTI (median age, 75 years; 309 males; diabetes mellitus, 73%; end stage renal failure with hemodialysis, 44%). The operative time decreased significantly as the number of cases accumulated (p < .001). Using the cumulative sum (CUSUM) operative time, the learning curve was estimated to be phase 1 (initial learning curve) for 134 cases (1-134); phase 2 (competent period) for 179 cases (135-313); and phase 3 (mastery and challenging period) for 136 cases (314-449). The mean follow-up period was 34 ± 31months. The 1- and 3-year limb salvage rates of 97% and 96% in phase 3 were significantly higher than those in phases 1 and 2 (p < .001, p = .029). Major adverse limb events (MALE) occurred in 117 (26%) patients, and the 1- and 3-year MALE rates of 10% and 17% in phase 3 were significantly lower than those in phases 1 and 2 (p < .001, p = .009). In the study, vascular surgeon required a learning curve of 134 TPB cases to Overcoming the learning curve for bypass was associated with improvement of medium-term outcomes for limb salvage and freedom from MALE.

Mobility Rates After Lower-Limb Amputation for Patients Treated with Physician-Led Collaborative Care Model

Clinical outcomes after major lower-limb amputation have been historically poor. The current care provided to most amputees is often disorganized and without physician supervision. The primary purpose of this study is to examine rates of postamputation mobility achieved with a prosthesis by patients with chronic limb-threatening ischemia and/or diabetes who required major lower-limb amputation and were treated under an established physician-led collaborative care pathway. The secondary purpose is to describe the structure and utilization of the care pathway by multiple independent vascular surgery practices in the United States to enable future exploration of its impact on key clinical outcomes within this patient population. Clinical records of 2,475 patients from 6 vascular practices that adopted this collaborative care pathway between 2017 and 2020 were retrospectively reviewed. Only records with sufficient documented histories of amputation surgeries, prosthetic services, and mobility status were included. Of 2,475 patient records reviewed, 1,787 patients (2,157 major amputations) were eligible for analysis. Sixty-two-point 2 percent (n=1,111) of patients achieved mobility with the collaborative care pathway. Mobility rate varied by amputation level in the study. Prosthetic mobility was achieved in 73.5% of transtibial amputations, 40.4% of transfemoral amputations, and 35.7% of through-knee amputations, regardless of patient laterality, which is superior or equivalent to the best published rates of mobility. The study describes the structure and utilization of a physician-led collaborative care pathway for treating patients who require lower-limb amputation that meets 5 of the 7 recommendations from the 2019 Global Vascular Guidelines on the Management of Chronic Limb Threatening Ischemia. Internal data analysis results suggest that patients treated via this care pathway can potentially achieve improved mobility rates with a prosthesis following amputation. This collaborative care pathway should be further evaluated for its ability to directly improve mobility and other clinically relevant amputation outcomes.

Peripheral Interventional Strategy Assessment (PISA) for Diabetic Foot Ulcer Revascularization: Preliminary Outcomes of a Multidisciplinary Pilot Study.

Digital subtraction angiography (DSA) still represents the gold standard for anatomical arterial mapping and revascularization decision-making in patients with chronic limb-threatening ischemia (CLTI), although DUS (Doppler Ultrasound) remains a primary non-invasive examination tool. The Global Vascular Guidelines established the importance of preoperative arterial mapping to guarantee an adequate in-line flow to the foot. The aim of this study was to evaluate the accuracy of DUS in guiding therapeutic vascular treatments on the basis of Global Vascular Guidelines without the need of a second-level examination. Between January 2022 and June 2022, all consecutive patients with CLTI to be revascularized underwent clinical examination and DUS without further diagnostic examinations. Primary outcomes assessed were technical success, and 30-day mortality. Secondary outcomes were 1-year amputation free survival, and time between evaluation and revascularization. Sixty-eight patients with a mean age of 73.6 ± 8.5 years underwent lower limb revascularization. Technical success was 100%, and the 30-day mortality rate was 2.9%. Mean time between evaluation and revascularization was 29 ± 17 days. One-year amputation free survival was 97.1%. DUS without further diagnostic examinations can accurately assess the status of the vascular tree and foot runoff, providing enough information about target vessels to guide revascularization strategies.

The effects of high quality team medicine on outcomes of chronic limb-threatening ischemia patients with infrapopliteal bypass.

A team approach for treatment of patients with CLTI is used worldwide. However, the quality of team medicine is a concern. The Global Vascular Guidelines provide recommendations for high quality team medicine, but there is limited knowledge of the significance of team quality in CLTI treatment. The objective of this study is to evaluate the effects of team quality on clinical outcomes after infrapopliteal bypass. A retrospective analysis was performed in 337 patients who underwent 414 infrapopliteal bypasses under a team medicine approach at a single center between 2009 and 2021. In 2017, team medicine was reorganized for improvement of quality. Comparisons were made between before (Group 1; 160 patients, 195 limbs) and after (Group 2; 177 patients, 219 limbs) reorganization. The primary endpoints were limb salvage and wound healing after infrapopliteal bypass. The patients included 227 males (67%) and had a median age of 76 [68-83]years. Diabetes mellitus was present in 67% and end-stage renal disease with hemodialysis in 37%. The follow-up rate was 96% in a mean follow-up period of 31±30months. The 3-year limb salvage rate was significantly lower in Group 1 (before reorganization) than in Group 2 (after reorganization) (84% vs 95%, p = .001). The wound healing rates in the whole cohort were 72% at 6months and 85% at 12months, with no significant differences between the groups. In multivariate analysis, the risk factors for major amputation were treatment before reorganization (HR 2.68; p = .017), hemodialysis (HR 2.27; p = .017), and non-ambulatory status (HR 2.63; p = .005). A reorganized team approach with the goal of higher quality was independently associated with reduced major amputation for patients with CLTI treated with infrapopliteal bypass. This result indicates the importance of a high quality team approach for success of this treatment.

Bypass Surgery Provides Better Outcomes Compared with Endovascular Therapy in Patients with Chronic Limb-Threatening Ischemia Classified as Indeterminate Category According to the Global Vascular Guidelines

The present study aimed to determine the preferred initial revascularization procedure between bypass surgery and endovascular therapy (EVT) in patients with chronic limb-threatening ischemia (CLTI) categorized as indeterminate according to the Global Vascular Guidelines (GVG). We retrospectively analyzed the multicenter data of patients who underwent infrainguinal revascularization for CLTI categorized as indeterminate according to the GVG between 2015 and 2020. The end point was the composite of relief from rest pain, wound healing, major amputation, reintervention, or death. A total of 255 patients with CLTI and 289 limbs were analyzed. Of the 289 limbs, 110 (38.1%) and 179 (61.9%) underwent bypass surgery and EVT, respectively. The 2-year event-free survival rates with respect to the composite end point were 63.4% and 28.7% in the bypass and EVT groups, respectively (P<0.01). Multivariate analysis revealed that increased age (P=0.03); decreased serum albumin level (P=0.02); decreased body mass index (P=0.02); dialysis-dependent end-stage renal disease (P<0.01); increased Wound, Ischemia, and foot Infection (WIfI) stage (P<0.01); Global Limb Anatomic Staging System (GLASS) III (P=0.04); increased inframalleolar grade (P<0.01); and EVT (P<0.01) were independent risk factors for the composite end point. In the WIfI-GLASS 2-III and 4-II subgroups, bypass surgery was superior to EVT with regard to 2-year event-free survival (P<0.01). Bypass surgery is superior to EVT in terms of the composite end point in patients classified as indeterminate according to the GVG. Bypass surgery should be considered an initial revascularization procedure, especially in the WIfI-GLASS 2-III and 4-II subgroups.

A Novel Score Predicts Need of Open Revascularization Following Endovascular Revascularization in Patients with Infrainguinal Chronic Limb-threatening Ischemia

This study aims to assess the ability of a novel score, the infrainguinal successful endovascular treatment (iSET) score in predicting risk of open revascularization in patients undergoing endovascular revascularization (ER) for infrainguinal chronic limb-threatening ischemia (CLTI). A retrospective analysis of consecutive patients undergoing ER for CLTI between January 2015 and December 2018. The iSET is a score between 1 and 63. It combines components of the Global Vascular Guidelines evidence-based revascularization as follows: iSET = Wound, Ischemia, foot Infection (WIfI) × WIFI + inflow disease + 4 × Global limb anatomic staging system (GLASS) FP + 6 × GLASS IP + 3 × IM pedal modifier. It stratifies patients into low (0-21), moderate (22-42), and high (43-63). The primary outcome was freedom from open revascularization at 2 years. Secondary outcomes were 30-day and 1-year endovascular reintervention, major amputations (above the ankle joint), minor amputations (below the ankle joint) and mortality. Kaplan-Meier estimates and Cox proportional hazard model assessed ability of iSET to predict open revascularization risk. A P value < .05 was significant. The study included 159 limbs in 150 patients with 12% (n = 19), 53% (n = 84), and 35% (n = 56) having a low, moderate, and high iSET scores, respectively. Most patients presented with tissue loss (86%), WIfI stage 4 (64%), and GLASS III (47%). Patients with a high iSET were more likely to have received antibiotics prior to ER (odds ratio, 1.35; 95% confidence interval [CI], 1.08-1.70; P = .013) and less likely to have elective ER (odds ratio, 0.36; 95% CI, 0.18-0.72; P = .003). Most ER involved the femoropopliteal segment (84%), with 55% of these including concomitant infrapopliteal revascularization. Kaplan-Meier survival curves showed that 2-year freedom from open revascularization was 100%, 93%, and 79% with low, moderate, and high iSET, respectively (Fig). Mortality, reinterventions, and major amputations were similar at 30 days and 1 year (Table). There was an increase in minor amputations at 1 year with high iSET patients (38%; n = 20) compared with low (6%; n = 1) and moderate (21%; n = 15) iSET (P = .016). High iSET score predicted increased risk of open revascularization (hazard ratio, 4.75; 95% CI, 1.67-13.48; P = .003). The iSET is a novel comprehensive score incorporating guideline-driven parameters. The score correlated significantly with ER failure at 2 years with progressively lower freedom from open revascularization between low, moderate, and high iSET scores. Additionally, a high iSET score independently predicted subsequent open revascularization after ER. Further studies are needed to validate it as an adjunctive decision-making tool in patients with CLTI.TableThirty-day and 1-year outcomes in patients stratified by groupsOverallLowModerateHighP-value30-day Death2 (3)03 (2)2 (1).775 Endovascular reintervention8 (11)08 (6)10 (5).447 Major amputation2 (2)02 (1)3 (1).848 Minor amputation13 (18)6 (1)8 (6)21 (11).0861-year Death11 (15)013 (9)11 (6).334 Endovascular reintervention34 (48)31 (5)33 (24)37 (19).885 Major amputation13 (18)014 (10)15 (8).262 Minor amputation25 (36)6 (1)21 (15)38 (20).016Data is presented as percentage (number). Open table in a new tab

Treatment outcomes between bypass surgery and endovascular therapy in patients with chronic limb-threatening ischemia classified as bypass-preferred category based on Global Vascular Guidelines

ObjectiveThe aim of this study was to examine outcomes between bypass surgery and endovascular therapy (EVT) in patients with chronic limb-threatening ischemia (CLTI), classified as bypass-preferred according to the Global Vascular Guidelines (GVG). MethodsWe retrospectively analyzed the multi-center data of patients who underwent infrainguinal revascularization for CLTI with Wound, Ischemia, and foot Infection (WIfI) Stage 3 to 4 and Global Limb Anatomical Staging System (GLASS) Stage III, which is classified as bypass-preferred category by the GVG between 2015 and 2020. The endpoints were limb salvage and wound healing. ResultsWe analyzed 301 patients and 339 limbs following 156 bypass surgeries and 183 EVTs. The 2-year limb salvage rates were 92.2% in the bypass surgery group and 76.3% in the EVT group, respectively (P < .01). The 1-year wound healing rates were 86.7% in the bypass surgery group and 67.8% in the EVT group (P < .01). Multivariate analysis shows decreased serum albumin level (P < .01), increased wound grade (P = .04), and EVT (P < .01) were risk factors for major amputation. Decreased serum albumin level (P < .01), increased wound grade (P < .01), GLASS infrapopliteal grade (P = .02), inframalleolar (IM) P grade (P = .01), and EVT (P < .01) were risk factors for impaired wound healing. Subgroup analysis of limb salvage in patients after EVT, decreased serum albumin level (P < .01), increased wound grade (P = .03), increased IM P grade (P = .04), and congestive heart failure (P < .01) were risk factors for major amputation. According to scoring by existence of these risk factors, 2-year limb salvage rates following EVT were 83.0% and 42.8% for the total score of 0 to 2 and of 3 to 4, respectively (P < .01). ConclusionsBypass surgery provides better limb salvage and wound healing in patients with WIfI Stage 3 to 4 and GLASS Stage III, which is classified as bypass-preferred category by the GVG. In patients after EVT, serum albumin level, wound grade, IM P grade, and congestive heart failure were related to major amputation. Although bypass surgery may be considered as initial revascularization procedure in patients classified as bypass-preferred category, in case that EVT has to be selected, relatively acceptable outcomes can be expected in patients with less of these risk factors.

Chronic Limb-Threatening Ischemia and the Need for Revascularization

Patients presenting with critical limb-threatening ischemia (CLTI) have been increasing in number over the years. They represent a high-risk population, especially in terms of major amputation and mortality. Despite multiple guidelines concerning their management, it continues to be challenging. Decision-making between surgical and endovascular procedures should be well established, but there is still a lack of consensus concerning the best treatment strategy. The aim of this manuscript is to offer an overview of the contemporary management of CLTI patients, with a focus on the concept that evidence-based revascularization (EBR) could help surgeons to provide more appropriate treatment, avoiding improper procedures, as well as too-high-risk ones. We performed a search on MEDLINE, Embase, and Scopus from 1 January 1995 to 31 December 2022 and reviewed Global and ESVS Guidelines. A total of 150 articles were screened, but only those of high quality were considered and included in a narrative synthesis. Global Vascular Guidelines have improved and standardized the way to classify and manage CLTI patients with evidence-based revascularization (EBR). Nevertheless, considering that not all patients are suitable for revascularization, a key strategy could be to stratify unfit patients by considering both clinical and non-clinical risk factors, in accordance with the concept of individual residual risk for every patient. The recent BEST-CLI trial established the superiority of autologous vein bypass graft over endovascular therapy for the revascularization of CLTI patients. However, no-option CLTI patients still represent a critical issue. The surgeon's experience and skillfulness are the cornerstones of treatment and of a multidisciplinary approach. The recent BEST-CLI trial established that open surgical peripheral vascular surgery could guarantee better outcomes than the less invasive endovascular approach.

Long-Term Results of Below-The-Knee Bypass Using a Prosthetic Graft with a Distal Arteriovenous Fistula Interposition

Surgical bypass is the gold standard treatment in patients affected by chronic limb-threatening ischemia in advanced GLASS stages, according to the Global Vascular Guidelines. For patients in whom an autologous graft is not available, a prosthesis could be used with the adjunct of a distal arteriovenous fistula interposition. The aim of this study was to examine the long-term results of below-the-knee surgical revascularization using a prosthesis with the distal adjunct mentioned above. From 2010 to 2020, we performed 159 lower limb below-the-knee surgical revascularizations using a prosthesis with the creation of an arteriovenous fistula interposition on the distal anastomosis. The GLASS stage was 3 in 100% of patients. The primary patency rates were as follows: 86.7% at 1 year, 57.2% at 3 years, and 12.6% at 5 years. The graft thrombosis rates were 17.4% at 1 year, 42.1% at 3 years, and 64.5% at 5 years. The amputation-free survival rates were 79% at 1 year, 76% at 3 years, and 64% at 5 years. PTFE prosthetic bypass for below-the-knee arteries using an arteriovenous fistula interposition is a good solution in patients without an autologous conduit. This technique offers reasonable graft patency and limb salvage rates.

Validity of the Global Vascular Guidelines in Predicting Outcomes Based on First-Time Revascularization Strategy

The Global Vascular Guidelines (GVG) recommend selecting an endovascular versus open-surgical approach to revascularization for chronic limb-threatening ischemia (CLTI), based on the Global Limb Anatomic Staging System (GLASS) and wound, ischemia, and foot infection (WIfI) classification systems. We assessed the utility of GVG-recommended strategies in predicting clinical outcomes. We conducted a single-center, retrospective review of first-time lower-extremity revascularizations within a comprehensive limb-preservation program from 2010 to 2018. Procedures were stratified by (1) treatment concordance with GVG-recommended strategy (concordant versus nonconcordant groups), (2) GLASS stages I-III, and (3) endovascular versus open strategies. The primary outcome was 5-year freedom from major adverse limb events (FF-MALE), defined as freedom from reintervention or major amputation, and secondary outcomes included 5-year overall survival, freedom from major amputation, freedom from reintervention, and immediate technical failure (ITF) during initial revascularization. Kaplan-Meier (KM) survival analysis and multivariate analysis with Cox proportional hazard models were performed on the primary and secondary outcomes. Of 281 first-time revascularizations for CLTI, 251 (89.3%) were endovascular and 186 (66.2%) were in the concordant group, with a mean clinical follow-up of 3.02±2.40years. Within the concordant group alone, 167 (89.8%) of revascularizations were endovascular. The concordant group had a higher rate of chronic kidney disease (60.8% vs. 45.3%, P=0.02), WIfI foot infection grade (0.81±1.1 vs. 0.56±0.80, P=0.03), and WIfI stage (3.1±0.79 vs. 2.8±1.2, P<0.01) compared to the non-concordant group. After both KM and multivariate analyses, there were no significant differences in 5-year FF-MALE or overall survival between concordant and non-concordant groups. There was higher freedom from major amputation in the non-concordant group on KM analysis (83.9% vs. 74.2%, P=0.025), though this difference was non-significant on multivariate analysis (hazard ratio [HR]: 0.49, 95% confidence interval [CI]: 0.21-1.15, P=0.10). The open group had lower MALE compared to the endovascular group (HR: 0.39, 95% CI: 0.17-0.91, P=0.029) attributed to a lower reintervention rate in the open group (HR: 0.31, 95% CI: 0.11-0.87, P=0.026). GLASS stage was not associated with significant differences in outcomes, but the severity of GLASS stage was associated with ITF (2.1% in stage 1, 6.4% in stage 2, and 11.7% in stage 3, P=0.01). In this study, CLTI treatment outcomes did not differ significantly based on whether treatment was received in concordance with GVG-recommended strategy. There was no difference in overall survival between the endovascular and open groups, though there was a higher reintervention rate in the endovascular group. The GVG guidelines are an important resource to help guide the management of CLTI patients. However, in this study, both concordance with GVG guidelines and GLASS staging were found to be indeterminate in differentiating outcomes between complex CLTI patients treated primarily with an endovascular-first approach. The revascularization approach for a CLTI patient is a nuanced decision that must take into account patient anatomy and clinical status, as well as physician skill and experience and institutional resources.

Perioperative therapeutic antibiotics are beneficial to prevent exacerbation of limb-associated infection after bypass surgery in patients with critical limb-threatening ischemia and foot infection score of ≥1.

Postoperative limb infection is associated with a poor prognosis and a low amputation-free survival rate after surgical revascularization in patients with critical limb-threatening ischemia. The Global Vascular Guidelines 2019 recommend antibiotic therapy for patients with deep space foot infection or wet gangrene; however, no study is cited as evidence for this recommendation. The present study was performed to offer new evidence supporting the use of perioperative therapeutic antibiotics in patients with critical limb-threatening ischemia (CLTI) undergoing surgical revascularization. This single-center retrospective study was performed in Kyushu University Hospital and involved patients with CLTI who underwent surgical revascularization from 2003 to 2021. Ampicillin/sulbactam and cefazolin were defined as preventive antibiotics, and other types were defined as therapeutic antibiotics. Postoperative limb-associated infection was defined as an increased foot infection (fI) score in the Wound, Ischemia, and foot Infection (WIfI) classification system after surgical revascularization. The association between perioperative antibiotic therapy and postoperative limb-associated infection was assessed. Among 286 limbs of 263 patients with CLTI, 27 (9%) limbs developed postoperative limb-associated infection after surgical revascularization. The fI scores were significantly higher in the patients with than without postoperative limb-associated infection (1.0 ± 0.2 vs 0.4 ± 0.1, respectively; p = 0.0033), indicating that an fI score of ≥1 was a risk factor for postoperative limb-associated infection. Perioperative therapeutic antibiotics significantly reduced the incidence of postoperative limb-associated infection compared with preventive antibiotics (0.0% vs. 44.8%, respectively; p = 0.0028) in the patients with CLTI who had an fI score of ≥1 after bypass surgery, although perioperative therapeutic antibiotics were not effective for patients with an fI score of 0. Perioperative therapeutic antibiotics for patients with an fI score of ≥1 are beneficial for reducing the incidence of postoperative limb-associated infection after surgical revascularization.

Limb outcomes based on limb severity and anatomic complexity following infrapopliteal vein bypass for Japanese patients with chronic limb-threatening ischemia

ObjectiveThe 2019 Global Vascular Guidelines recommend a suitable initial revascularization method with reference to limb severity (wound, ischemia, and foot infection [WIfI] stage) and anatomic complexity (Global Limb Anatomical Staging System [GLASS] stage). However, limb outcomes after revascularization among WIfI and GLASS stages have not been investigated fully after infrapopliteal vein bypass. The purpose of this study was to assess the four Global Vascular Guideline-recommended limb outcomes after infrapopliteal vein bypass in cases with different WIfI and GLASS stages. MethodsPatients who underwent infrapopliteal vein bypass for chronic limb-threatening ischemia at a single center were analyzed retrospectively. Medium-term limb outcomes were compared among WIfI and GLASS stages. The primary end points were limb salvage rate and major to minor amputation ratio, and the secondary end points were wound healing rate and wound healing time. ResultsA total of 353 infrapopliteal vein bypasses were performed in 284 patients with tissue loss (male, 193 patients; median age, 77 years; diabetes, 71%; hemodialysis, 41%). A total of 111 limbs (31%) required only minor amputation and 38 limbs (11%) required major amputation. The major to minor amputation ratio was 0.34 with no significant differences among WIfI stages or GLASS stages. The 3-year limb salvage rate was 87%. This rate was significantly lower in WIfI stage 4 than in stage 2 (P = .049), but did not differ significantly among GLASS stages. The 12-month wound healing rate was 86%. This rate was also significantly lower in WIfI stage 4 than in stages 2 and 3 (both P < .001), but did not differ significantly among GLASS stages. The median wound healing time was 55 days (range, 32-110 days), and was significantly longer in WIfI stage 4 compared with stages 2 (P = .001) and 3 (P < .001), but showed no significant differences among GLASS stages. ConclusionsThe limb salvage rate, wound healing rate, and wound healing time were associated with limb severity (WIfI stage), but not with anatomic complexity (GLASS stage). These findings suggest that an appropriate preoperative strategy and careful perioperative management are important for patients with greater limb severity.

Outcomes of a bypass-first strategy in chronic limb-threatening ischemia based on the Global Vascular Guidelines.

The Global Vascular Guidelines (GVGs) recommend initial revascularization (bypass or endovascular therapy) for chronic limb-threatening ischemia (CLTI) based on anatomical complexity and limb severity. This decision is made based on a prediction of the outcomes after endovascular intervention. This study was performed to evaluate outcomes after distal bypass in cases recommended for GVG bypass. A total of 239 distal bypasses for CLTI were evaluated in 195 patients with a GVG bypass recommendation treated between 2009 and 2020 at a single center in Japan. Comparisons were made between crural and pedal bypass cases. The 195 patients (median age, 77years; 67% male) underwent 133 crural bypasses (106 patients; 54%) and 106 pedal bypasses (89 patients; 46%). Hemodialysis was more common in pedal cases than in crural cases (P= .03). Hospital deaths occurred in two cases (1%) within 30days. The whole cohort has a follow-up rate of 96% over a mean of 28± 26months, with 3-year limb salvage rates of 87% and 3-year primary, assisted primary, and secondary patency rates of 40%, 65%, and 67%, all without significant differences between crural and pedal cases. The 1-year wound healing rate was 88% and tended to be higher in crural cases than in pedal cases (P= .068). The 3-year survival rate was 52% in the cohort and did not differ significantly between crural and pedal cases. Patients with CLTI with a GVG bypass recommendation had acceptable limb salvage, graft patency, wound healing, and survival after distal bypass, regardless of the bypass method. These findings indicate that a GVG bypass recommendation as an initial revascularization method is valid in the real world.

Outcomes of a bypass-first strategy in chronic limb-threatening ischemia based on the Global Vascular Guidelines

Outcomes of a bypass-first strategy in chronic limb-threatening ischemia based on the Global Vascular Guidelines

The DEFINITE Audit: a prospective audit of diabetic foot debridement in theatre – a protocol

Background: People with diabetes are commonly affected by foot ulceration (DFU) and subsequent or concurrent infection (DFI). Surgical debridement is often needed to contain infection. Despite international guidelines, there remains significant variation in surgical practice of diabetic foot wound debridement in the operating theatre. Methods: Diabetic Foot Ulcer Debridement in Theatre Audit (DEFINITE) is a global multicentre, prospective audit of consecutive patients undergoing a debridement or minor amputation in theatre for a diabetic foot complication. DEFINITE is led by the Vascular and Endovascular Research Network (VERN). The primary outcome is adherence to recommended practice as outlined in the International Working Group on the Diabetic Foot and Global Vascular Guidelines. Secondary outcomes are incidence of healing, re-admission, further amputation (minor and major) and mortality at 90 days. Anonymised data will be collected via REDCap. Eligibility and study registration at all hospital institutions performing in-theatre management of diabetic foot complications are eligible to participate after obtaining appropriate institutional level audit approvals. A lead clinician will be responsible for approvals and data management. Pathway to impact: This audit addresses shared patient-clinician priorities and is supported by the UK Vascular Society multidisciplinary Special Interest Group on the Diabetic Foot. The results will be presented at international scientific meetings and submitted for publication in peer-reviewed publications. The results will also be used to initiate improvement in patient care.

Severe inframalleolar disease is an independent predictor of adverse limb outcomes after endovascular revascularization in chronic limb-threatening ischemia

ObjectiveIn the present study, we evaluated the effects of inframalleolar (IM) disease on the occurrence of major adverse limb events (MALE) in patients undergoing endovascular revascularization for chronic limb-threatening ischemia (CLTI). MethodsPatients who had undergone endovascular revascularization for CLTI between January 2015 and December 2019 at two university-affiliated hospitals were reviewed retrospectively. Patients with severe IM disease (pedal score of 2) were compared with those with mild to moderate IM disease (score of 0 or 1) using the Global Vascular Guidelines. The primary outcome was MALE (open revascularization, acute leg ischemia, major amputation). The secondary outcomes were mortality, reintervention, major adverse cardiac events, and perioperative complications ≤30 days after endovascular revascularization, primary limb-based patency, and the occurrence of any limb event (defined as any amputation, acute leg ischemia, or open revascularization). Kaplan-Meier estimates were used to compare the primary outcome, and the Cox proportion hazard model was used to assess the effects of IM disease. ResultsThe study included 167 limbs in 149 patients (36% female; mean age, 74 ± 12 years). Severe IM disease was identified in 71 limbs (43%). No differences were found in the baseline characteristics, except for a higher prevalence of dyslipidemia in the patients with severe IM disease (66% vs 43%; P = .003). Most patients in both groups had had a WIfI (Wound, Ischemia, foot Infection) score of 4 (severe IM disease, 64%; vs mild to moderate IM disease, 57%; P = .462) and GLASS (global limb anatomic severity scale) III anatomy (severe IM disease, 54%; vs mild to moderate IM disease, 48%; P = .752). The Kaplan-Meier estimates showed that severe IM disease was associated with lower freedom from MALE (69% vs 82%; P = .026). The Cox proportion hazard regression model showed that severe IM disease was an independent predictor of increased MALE and amputation risk (hazard ratio, 1.715; 95% confidence interval, 1.015-2.896; P = .044) after adjusting for covariates. During follow-up, patients with severe IM disease had had mortality (27% vs 31%; P = .567) and reintervention (42% vs 38%; P = .608) similar to those for patients with mild to moderate IM disease. Primary limb-based patency was also similar (79% vs 84%; P = .593) at a mean follow-up of 3.8 ± 0.8 years. ConclusionsSevere IM disease was prevalent in 43% of limbs that had undergone endovascular revascularization for CLTI and was associated with lower freedom from MALE. Severe IM disease also independently increased the hazard of adverse limb outcomes and amputations in patients with CLTI by >70%, highlighting its importance as a measure of foot perfusion.