Global Limb Anatomic Staging System Research Articles

Poor Limb Prognosis of Patients with Chronic Limb-Threatening Ischemia on Hemodialysis: A Retrospective Observational Study Based on the Global Limb Anatomic Staging System

The Global Limb Anatomic Staging System (GLASS) has been widely used to evaluate patients with chronic limb-threatening ischemia (CLTI). As end-stage kidney disease (ESKD) is a well-known CLTI risk factor, we aimed to determine whether patients on hemodialysis (HD) have a worse limb prognosis than those without ESKD, considering the same GLASS background. The data of 445 patients who underwent surgical and/or endovascular revascularization procedures for lower extremity ischemia were retrospectively collected in our division between 2005 and 2018. The major amputation rate and amputation-free survival (AFS) were compared between HD and non-HD patients. Among the 215 (48%) patients receiving HD, 58 limbs required major amputation (27% limb loss rate). Among the non-HD group, the limb loss rate was 13% (P<0.0001). The overall AFS was significantly worse in patients receiving HD than those not (P<0.0001). The AFS was significantly worse in HD patients when comparing GLASS-standardized subgroups. Patients with CLTI who were receiving HD had a worse limb prognosis than those not receiving, even when considering the same GLASS classification. Furthermore, there is a need for an ideal guideline focused on ESKD-directed peripheral artery disease.

Study on mid-term outcomes of atherectomy for patients with femoral popliteal artery lesions with different Global Limb Anatomic Staging System grades.

To investigate the mid-term efficacy and patency rate of TurboHawk peripheral plaque excision system in the treatment of femoral popliteal artery lesions with different Global Limb Anatomic Staging System (GLASS) grades. The clinical data of 141 patients with femoral popliteal arteriosclerosis obliterans who were treated with TurboHawk from January 2018 to July 2022 in our institution were retrospectively analyzed. There were 109 male patients and 32 female patients. Recordings were made of the patient's symptoms of limb ischemia, technical success rate, primary patency rate of target vessels, ankle brachial index (ABI), GLASS grades, postoperative complications, and a statistical analysis with the patient's preoperative treatment was conducted. All patients had improved limb ischemia symptoms to varying degrees after surgery, with a technical success rate of 100% (femoral artery puncture and superficial femoral artery recanalization) without bleeding, hematoma, pseudoaneurysm, arteriovenous fistula or other complications. The follow-up period was 1-24 months, during which the severity of claudication, resting pain, and toe ulcers significantly improved. The primary patency rate of the target vessel was 98.58% (139/141), and the ABI significantly increased on the second day, three months, and six months after surgery compared to before surgery. No major adverse events were found during follow-up. The patency rates at 1, 6, 12 and 24 months after intervention were 100%, 80%, 75% and 60% respectively. The mid-term efficacy and patency rate of TurboHawk in the treatment of femoral popliteal artery lesions with GLASS I patients have the best mid-term prognosis, the highest mid-term survival rate, and the highest vascular patency. The plaque removal system has proven to be an effective treatment for individual localized chronic total occlusion lesions. Additionally, the TurboHawk system provides a safe and minimally invasive treatment alternative for superficial femoral artery conditions, achieving significant therapeutic results within a brief period.

Dichotomous grouping of peripheral arterial calcification grades: A practical predictor of outcome after endovascular therapy in peripheral arterial disease.

There is a general agreement that arterial calcification affects the results of endovascular therapy for peripheral arterial disease (PAD). In addition to lacking evidence for their impact, existing calcification scores are complex, and not practical in everyday decision making. The global limb anatomic staging system (GLASS) adopted dichotomous grouping of calcification grades. In this study we aim to investigate the impact of peripheral arterial calcification scoring after dichotomous grouping on midterm outcomes following endovascular therapy for PAD. This prospective study included all consecutive patients with PAD indicated for endovascular therapy procedure who presented to our tertiary referral center in the period between October 2020 and October 2021. Patients were grouped into Group A (n = 40): with no-to mild calcification (PACSS grade 0,1 and 2), and Group B (n = 53): with severe calcification (PACSS grades 3 and 4). Primary endpoints included technical success rate, primary patency rates, and major adverse limb events rate (MALE) during 2years of follow-up. The mean age of the studied cases (n = 93) was 59.31 ± 6.46years (range 50-75). 70 patients (75.3%) were males, and 23 (24.7%) were females. There was no statistically significant difference between the two groups regarding technical success rate (97.5% in group A versus 94.33% in Group B, p = .457). The Primary patency rate after 1year was lower in group B (74%) compared to group A (89.7%), but this difference was not statistically significant (p = .059). However, the 2-year primary patency rate was significantly lower in group B compared to group A (64% versus 84.6% respectively, p = .034). MALE rate after 2years was significantly higher in group B (28%) as compared to group A (10.4%), P = .048. Studying suspected risk factors revealed that severe calcification was more common in patients with ischemic heart disease (34%) and chronic kidney disease (11%), P= .003 and .002 respectively. Logistic regression analysis showed that patients suffered from IHD and those with length of lesion ≥ 5cm are about five times more likely to have severe calcification compared to their counterparts (OR = 4.875, 95%CI = 1.293-18.383, p = .019, and OR = 4.513, 95% CI = 11.138-17.893, p = .032), respectively. The presence of severe calcification is associated with significantly lower midterm primary patency rates and higher rate of major adverse limb events after endovascular intervention for lower limb denovo arterial lesions.

Infrapopliteal 3-Vessel Occlusive Disease Is the Only Predictor of Wound Recurrence After Complete Wound Healing via Endovascular Therapy in Patients With Chronic Limb-threatening Ischemia.

To determine the predictors of wound recurrence after complete wound healing in patients with chronic limb-threatening ischemia (CLTI) who underwent endovascular therapy (EVT) for infrapopliteal (IP) lesions with consideration of IP arterial anatomic severity, including classification by the Global Limb Anatomic Staging System (GLASS). This retrospective single-center study assessed patients with de novo CLTI limbs with tissue loss treated via EVT for IP lesions from September 2016 to May 2021. Among these patients, 149 consecutive limbs from 133 patients who achieved complete wound healing were enrolled. The Kaplan-Meier method was used to estimate the wound recurrence rate after complete wound healing. The Cox proportional hazard model was used to assess the association between baseline characteristics and wound recurrence. The cumulative wound recurrence rate 1 year after complete wound healing was 30%. The mean time for wound recurrence was 7±5 months. Only IP arterial anatomic characteristics remained as a predictor of wound recurrence, whereas wound status and management, including the Wound, Ischemia, and foot Infection (WIfI) clinical stage and minor amputation, were not associated with wound recurrence. Multivariate analysis revealed independent associations between wound recurrence and IP 3-vessel occlusive disease (hazard ratio, 2.97; 95% confidence interval, 1.39-6.35), but not poor below-the-ankle runoff, IP Peripheral Arterial Calcium Scoring System (PACSS) grade, and the GLASS IP grade. The only independent predictor of wound recurrence after complete wound healing via EVT in patients with CLTI was IP 3-vessel occlusive disease. In patients with chronic limb-threatening ischemia (CLTI), wound recurrence after complete wound healing remains a challenge, and studies focused exclusively on wound recurrence are still limited. The present study aimed to determine the risk factors for wound recurrence after complete wound healing in patients with CLTI who underwent endovascular therapy (EVT) for infrapopliteal (IP) lesions, with consideration of IP arterial anatomic severity for the first time. The results showed that IP 3-vessel occlusive disease was the only predictor of wound recurrence, whereas wound status/management and other arterial anatomic characteristics including WIfI clinical stages and GLASS grades were not predictors.

Topicality of the fundamental and determining importance of chronic critical ischemia of the extremities and its restorative treatment using crural/pedal bypasses in Germany and in Saxony-Anhalt

Currently, there is an increase in severe stages of peripheral arterial occlusive disease (PAOD) with critical ischemia. This seems to correspond to the general demographic change as well as aconsequence of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic of the last 3years. The now established and accepted interventional/endovascular approach for severe lower leg PAOD in experienced hands is still considered the first-line treatment but from the authors' perspective crural/pedal venous bypass is experiencing arenaissance. Compact narrative review of the current state of crural/pedal bypass surgery in Germany and Saxony-Anhalt (SA) combined with selective references from the current scientific medical literature and own clinical experiences. The current statistics of case-related diagnosis-related groups (DRG) data show that, especially with the occurrence of the corona pandemic, adecrease in inpatient case numbers of patients with PAOD stage IIB can be observed nationwide and also in SA. The severe PAOD stages have remained approximately the same in case numbers but increased in SA. The risk stratification based on the wound, ischemia and foot infection (WIFI) classification offers the possibility to be able to make statements about the risk of amputation, benefits and type of revascularization measures. The length of the occlusion, occlusion site of the affected vessels and degree of calcification are taken into account in the global limb anatomic staging system (GLASS) to assess the prognosis. The evaluation of the case-based hospital statistics from 2015 to 2020 showed aconstant use of femorocrural/femoropedal bypass surgery in Germany as well as aslight increase in reconstruction using femorocrural bypasses in SA, which seems to correlate with the tendency for an increase in the number of cases of severe PAOD. Parameter-based objectification of the severity of critical limb ischemia should be included in the indications for placement of a crural/pedal bypass. The WIFI classification and GLASS are suitable for this purpose as arelative prognosis of success is also possible. The treatment of critical limb ischemia by crural/pedal bypass surgery continues to find aconstant application in Germany and SA.

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.

Young Patients with Claudication and Chronic Limb-threatening Ischemia Have Worse Limb-specific Outcomes After Infrainguinal Bypasses

Although the prevalence of claudication and chronic limb-threating ischemia (CLTI) has increased in younger patients, less is known about the age-based differences in treatment and outcomes. This study compares the differences in limb-specific outcomes and predictors of complications in younger patients who undergo open operative intervention. The American College of Surgeons National Surgical Quality Improvement Project targeted lower extremity bypass database was used from 2012 to 2021. Bypasses for claudication and CLTI were analyzed separately. A histogram of limb-specific outcomes vs age showed adverse events markedly dropped around 65 years old. Thus, we stratified cases into younger patients (≤65 years old) and older patients (>65 years old). Primary outcomes included 30-day mortality, major organ dysfunction, and major amputations. To supplement the lack of long-term data and angiographic details in the National Surgical Quality Improvement Project, institutional data from 2017 to 2022 with 6-month follow-up was also analyzed. There were 5789 patients with claudication (2526 younger vs 3263 older) and 16,675 patients with CLTI (5948 younger vs 10,205 older). In both cohorts, younger patients were more likely to be obese and smokers but have independent function. Younger patients were less likely to have significant comorbidities including hypertension, chronic obstructive pulmonary disorders, and high-risk physiologic factors. Although younger age was independently associated with lower mortality in both claudication and CLTI (aOR, 0.32; P = .013; aOR, 0.40; P ≤ .001, respectively), patients had significantly worse limb-specific outcomes. Younger age was associated with increased untreated loss of patency (aOR, 2.68; P ≤ .001) and reoperation (aOR, 1.35; P = .045) in the claudication cohort and increased wound complications (aOR, 1.11; P = .038) and major amputation (aOR, 1.47; P ≤ .001) in the CLTI cohort (Table). A total of 96 institutional patients with CLTI were reviewed, of which 58 (60.4%) were younger than 65. There was no difference in graft material, orientation, or preoperative wounds, ischemia, and foot Infection score among age groups. Young patients, however, had significantly worse Global Limb Anatomic Staging System pedal scores. Although young patients have lower 30-day mortality after infrainguinal bypass, they have higher risk of limb-specific complications. Worse pedal Global Limb Anatomic Staging System scores may suggest the presence of more aggressive disease. Bypass for young patients with claudication should be done with extreme caution whereas bypass for CLTI may require more diligent postoperative follow-up.TableYounger patients are more likely to have limb-specific complications after infrainguinal open bypass than older patientsClaudicationCLTIYounger (n = 2526) vs older (n = 3263) patientsYounger (n = 5948) vs older (n = 10205) patientsAdjusted odds ratio95% Confidence intervalP valueAdjusted odds ratio95% Confidence intervalP valueMortality0.320.130.78.0120.500.310.54<.001MACE0.911.350.61.6130.800.670.79.009Pulmonary complications0.981.682.69.9420.860.951.05.130Wound complications1.040.871.23.6811.111.001.23.038Untreated loss of patency2.681.594.55<.0011.050.831.32.686Major amputation1.580.773.27.2161.481.231.76<.001Reoperation1.361.011.83.0461.150.991.32.052MACE, Major adverse cardiac events, including myocardial infarction, stroke, and cardiac arrest.Boldface entries indicate statistical significance. Open table in a new tab

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.

Angiosome Oriented or Least Diseased Vessel, Which Is the Optimal Target Arterial Path for Endovascular Revascularisation in Patients With Diabetic Foot Ulcers?

The aims were to determine whether, when treating diabetic foot ulcers (1), selecting an angiosome directed (AD) vessel as the target arterial path (TAP) when candidate vessels have comparably severe disease impacts outcomes and (2) whether a more severely affected AD vessel or a less severely affected non-angiosome directed (NAD) vessel should be chosen. This was a retrospective observational study. Patients with diabetic foot ulcers who had undergone endovascular revascularisation in the institution between January 2016 and May 2020 and had been followed up for two years were included. Eligible patients were identified retrospectively and relevant data were collected from the institution's electronic medical records. The severity of the lesions was classified using the Global Limb Anatomic Staging System (GLASS). Outcomes between various subgroups were compared according to the severity of the lesions to determine the optimal TAP choice in each case. The study cohort comprised 215 patients (216 limbs). The affected limbs were classified as follows: 93 (43.1%) as GLASS 1 - 2 AD; 27 (12.5%) as GLASS 1 - 2 NAD, 62 (28.7%) as GLASS 3 AD, and 34 (15.7%) as GLASS 3 NAD groups. In the GLASS 1 - 2 group, rates of ulcer healing, survival, and amputation free survival were higher and time to healing shorter in the AD than NAD group. In the GLASS 3 group, there were no significant differences between the AD and NAD groups for any studied outcome measures, including ulcer healing and overall survival. Using a more severely diseased AD as the TAP did not achieve significantly better outcomes than using a less severely affected NAD vessel. Selecting the AD vessel may achieve better outcomes when two candidate TAPs belong to GLASS 1-2, whereas selecting the least diseased vessel as the TAP regardless of AD or NAD status may be preferable in other situations.

Role of the Global Limb Anatomic Staging System in predicting outcomes of chronic limb-threatening ischemia in patients treated by drug-coated balloons.

The Global Limb Anatomic Staging System (GLASS) was proposed to assess the procedural complexity and technical failure rate and stratify the anatomic pattern of chronic limb-threatening ischemia (CLTI). However, more evidence is needed to validate the GLASS in staging outcomes after endovascular therapy in patients with CLTI treated with drug-coated balloons (DCBs). This study aims to evaluate the role of the GLASS in predicting outcomes of CLTI patients treated with DCBs. This multicenter, retrospective cohort study enrolled patients with CLTI treated with DCBs from July 2016 to June 2019. GLASS stages were assigned for every limb. The limb-based patency (LBP) rate, clinically driven target lesion revascularization (CD-TLR) rate, clinical improvement, and safety endpoints were analyzed and compared across the GLASS stages over 12 months of follow-up. Risk factors for the loss of LBP were identified using Cox regression analysis. A total of 90 limbs were enrolled, with 55 (61.1%) having isolated femoropopliteal lesions and 35 (38.9%) having femoropopliteal and infrapopliteal lesions. Of the limbs, 17 (18.9%), 12 (13.3%), and 61 (67.8%) were assigned to GLASS stages I, II, and III, respectively. The Kaplan-Meier estimate of the 12-month LBP was 65.4%, and no difference was found among the different stages (stage I 81.1%; stage II 85.2%; stage III 54.4%; P=0.080). The LBP was lower in stage III than in stages I and II combined (stage I and II 83.5%; stage III 54.4%; P=0.027). Similar results were found for the freedom from CD-TLR rates among the different stages. The ankle-brachial index values improved from 0.42±0.29 to 0.78±0.35 at follow-up (P<0.001). The rates of mortality, any amputation, and major amputation were similar among the groups. GLASS stage III and coronary heart disease were identified as independent risk factors for the loss of LBP at 12 months. The 1-year LBP and freedom from CD-TLR rates were lower in GLASS stage III than in stages I and II. The GLASS classification could predict the outcomes of CLTI patients with femoropopliteal lesions treated with DCB.

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.

Lower-extremity pressure, staging, and grading thresholds to identify chronic limb-threatening ischemia.

The Society for Vascular Surgery Threatened Limb Classification System ('WIfI') is used to predict risk of limb loss and identify peripheral artery disease in patients with foot ulcers or gangrene. We estimated the diagnostic sensitivity of multiple clinical and noninvasive arterial parameters to identify chronic limb-threatening ischemia (CLTI). We performed a single-center review of 100 consecutive patients who underwent angiography for foot gangrene or ulcers. WIfI stages and grades were determined for each patient. Toe, ankle, and brachial pressure measurements were performed by registered vascular technologists. CLTI severity was characterized using Global Limb Anatomic Staging System (GLASS stages) and angiosomes. Medial artery calcification in the foot was quantified on foot radiographs. GLASS NA (not applicable), I, II, and III angiographic findings were seen in 21, 21, 23, and 35 patients, respectively. A toe-brachial index < 0.7 and minimum ipsilateral ankle-brachial index < 0.9 performed well in identifying GLASS II and III angiographic findings, with sensitivity rates 97.8% and 91.5%, respectively. The diagnostic accuracy rates of noninvasive measures peaked at 74.7% and 89.3% for identifying GLASS II/III and GLASS I+ angiographic findings, respectively. The presence of medial artery calcification significantly diminished the sensitivity of most noninvasive parameters. The use of alternative noninvasive arterial testing parameters improves sensitivity for detecting PAD. Abnormal noninvasive results should suggest the need for diagnostic angiography to further characterize arterial anatomy of the affected limb. Testing strategies with better accuracy are needed.

Presence of a patent pedal arch is the primary predictor of transmetatarsal amputation healing and limb salvage

ObjectiveTransmetatarsal amputation (TMA) is a durable and important functional limb salvage option. We have presented our results in identifying the angiographic predictors of TMA healing using single-institution retrospective data. MethodsConsecutive patients within our institution who had undergone TMA and lower extremity arteriography from 2012 to 2020 were included. Patients whose TMA had healed were compared with those whose TMA had not healed. Using pre- and perioperative patient factors, in addition to the Global Limb Anatomic Staging System (GLASS) and evaluation of the tibial runoff vessels, multivariate analysis was used to define the predictors of TMA healing at 30 days and 1 year. For those patients who had undergone an intervention after TMA, including repeat interventions, the postintervention GLASS stage was calculated. All patients were followed up by the vascular surgeon using standard ultrasound surveillance and clinical examinations. Once the predictors had been identified, an analysis was performed to correlate the 30-day and 1-year limb salvage rates. ResultsA total of 89 patients had met the inclusion criteria for the study period. No difference was found in the GLASS femoropopliteal or infrapopliteal stages for those with a healed TMA and those without. After multivariate regression analysis, the presence of a patent pedal arch vs a nonintact arch had a 5.5 greater odds of TMA healing at 30 days but not at 1 year. Additionally, the presence of a patent arch was strongly associated with limb salvage at both 30 days (86% vs 49%; P < .01) and 1 year (79% vs 49%; P < .01). ConclusionsIn the present series of patients who had undergone TMA and arteriography, with appropriate GLASS staging, we found patency of the pedal arch was a significant predictor of healing and limb salvage. The GLASS femoropopliteal and infrapopliteal stages did not predict for TMA healing.

High Global Limb Anatomic Staging System Femoropopliteal Grade is Positively Associated with Wound Healing in Patients with Chronic Limb-Threatening Ischemia Undergoing Endovascular Therapy Only for Femoropopliteal Disease

To investigate the prognostic impact of femoropopliteal (FP) arterial anatomic severity including classification by the Global Limb Anatomic Staging System (GLASS) on wound healing in patients with chronic limb-threatening ischemia (CLTI) who had undergone endovascular therapy (EVT) only for FP lesions. This was a retrospective single-center study. We treated 349 consecutive de novo CLTI limbs with tissue loss from January 2017 to May 2021. Among these, 91 limbs treated via EVT only for FP lesions were enrolled. We compared the clinical background, infrapopliteal (IP)/FP arterial anatomical characteristics, and EVT results between the limbs with GLASS FP grade 1 or 2 (low GLASS FP, n = 20) and those with GLASS FP grade 3 or 4 (high GLASS FP, n = 71). The Kaplan-Meier method was used to estimate the wound healing rate. The Cox proportional hazard model was used to assess the association between baseline characteristics and wound healing. No patient underwent EVT for IP lesions. IP arterial anatomical characteristics did not show any significant difference between the low and high GLASS FP groups. The cumulative wound healing rate after EVT was significantly higher in the high GLASS FP group than in the low GLASS FP group (88% vs. 39% at 6 months; p < 0.001). Multivariate analysis revealed that low wound, ischemia, and foot infection (WIfI) clinical stage (stage 1 or 2) (hazard ratio [HR] 2.33; 95% confidence interval [CI] 1.32-4.17) and high GLASS FP (grade 3 or 4) (HR 5.18; 95% CI 1.99-13.51) were independent factors for wound healing. High GLASS FP grade was positively associated with wound healing after EVT only for FP lesions.

Outcomes and Patency of Endovascular Infrapopliteal Reinterventions in Patients With Chronic Limb-Threatening Ischemia

Purpose: Endovascular revascularization is the preferred treatment to improve perfusion of the lower extremity in patients with chronic limb-threatening ischemia (CLTI). Patients with CLTI often present with stenotic-occlusive lesions involving the infrapopliteal arteries. Although the frequency of treating infrapopliteal lesions is increasing, the reintervention rates remain high. This study aimed to determine the outcomes and patency of infrapopliteal endovascular reinterventions. Methods: This retrospective, multicenter cohort study of 3 Dutch hospitals included patients who underwent an endovascular infrapopliteal reintervention in 2015 up to 2021 after a primary infrapopliteal intervention for CLTI. The outcome measures after the reintervention procedures included technical success rate, the mortality rate and complication rate (any deviation from the normal postinterventional course) at 30 days, overall survival, amputation-free survival (AFS), freedom from major amputation, major adverse limb event (MALE), and recurrent reinterventions (a reintervention following the infrapopliteal reintervention). Cox proportional hazard models were used to determine risk factors for AFS and freedom from major amputation or recurrent reintervention. Results: Eighty-one patients with CLTI were included. A total of 87 limbs underwent an infrapopliteal reintervention in which 122 lesions were treated. Technical success was achieved in 99 lesions (81%). The 30-day mortality rate was 1%, and the complication rate was 13%. Overall survival and AFS at 1 year were 69% (95% confidence interval [CI], 55%–79%) and 54% (95% CI, 37%–67%), respectively, and those at 2.5 years were 45% (95% CI, 33%–56%) and 21% (95% CI, 11%–33%), respectively. Freedom from major amputation, MALE, and recurrent reinterventions at 1 year and 2.5 years were 59% (95% CI, 46%–70%) and 41% (95% CI, 25%–56%); 54% (95% CI, 41%–65%) and 36% (95% CI, 21%–51%); and 68% (95% CI, 55%–78%) and 51% (95% CI, 33%–66%), respectively. A Global Limb Anatomic Staging System score of III showed an increased hazard ratio of 2.559 (95% CI, 1.078–6.072; p=0.033) for freedom of major amputation or recurrent reintervention. Conclusions: The results of this study indicate that endovascular infrapopliteal reinterventions can be performed with acceptable 30-day mortality and complication rates. However, outcomes and patency were moderate to poor, with low AFS, high rates of major amputations, and recurrent reinterventions. Clinical Impact This multicenter retrospective study evaluating outcome and patency of endovascular infrapopliteal reinterventions for CLTI, shows that endovascular infrapopliteal reinterventions can be performed with acceptable 30-day mortality and complication rates. However, the short- and mid-term outcomes of the infrapopliteal reinterventions were moderate to poor, with low rates of AFS and a high need for recurrent reinterventions. While the frequency of performing infrapopliteal reinterventions is increasing with additional growing complexity of the disease, alternative treatment options such as venous bypass grafting or deep venous arterialization may be considered and should be studied in randomized controlled trials.

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.

Open revascularization approach is associated with healing and ambulation after transmetatarsal amputation in patients with chronic limb threatening ischemia

BackgroundTransmetatarsal amputation (TMA) allows for maintenance of ambulatory function for patients with significant forefoot tissue loss. Effective revascularization is key to optimizing limb salvage for patients with chronic limb threatening ischemia (CLTI). We hypothesized that CLTI patients requiring TMA will have better healing and functional outcomes with open bypass than with endovascular revascularization. MethodsConsecutive TMAs performed at three affiliated centers between 2008 and 2020 were retrospectively reviewed. The baseline characteristics, including WIfI (wound, ischemia, foot infection) stage, noninvasive vascular studies, healing, and ambulatory outcomes, were collected. Catheter-based angiographic images were evaluated using the GLASS (global limb anatomic staging system). The primary outcomes were TMA healing and community ambulation. The secondary outcomes were TMA that had healed at study end, any ambulatory function postoperatively, major amputation, and mortality. Descriptive statistics and univariate, multivariable, and Kaplan-Meier analyses were performed. ResultsA total of 346 TMAs had been performed in 318 patients, 209 of whom had had peripheral artery disease (PAD). The median follow-up was 2.5 years. Patients with PAD had had significantly lower rates of healing compared with those without PAD (64% vs 77%; P = .007). Revascularization was performed in 185 limbs, with 102 treated endovascularly and 83 with open surgery. The patients who had undergone endovascular surgery were significantly less likely to have had the TMA healed at any point (55% vs 76%; P = .003) and less likely to have remained healed at study end (49% vs 66%; P = .02). Patients with GLASS stage 3 anatomy were significantly more likely to have healed after open surgery (75% vs 45%; P = .003). Long-term ambulation data were available for 72% of the revascularized patients. Endovascular surgery was associated with a lower likelihood of community ambulation after TMA (34% vs 57%; P = .002). On multivariable analysis, open surgery was significantly associated with TMA healing (odds ratio, 2.8; P = .007) and ambulation (odds ratio, 2.9; P = .001). ConclusionsFor patients with CLTI and significant tissue loss requiring TMA, an initial open approach to revascularization was associated with improved healing and higher rates of ambulation compared with endovascular interventions. The metabolic requirement for healing of a TMA in patients with CLTI might be better met by open revascularization.

The Relationship Between the Global Limb Anatomic Staging System Inframalleolar Modifier and the Outcomes of Diabetic Foot Ulcer with Peripheral Artery Disease

We aimed to investigate the relationship between the condition of the inframalleolar (IM) arteries, as assessed by the Global Limb Anatomic Staging System Inframalleolar (GLASS IM) modifier, and the outcomes of patients with diabetic foot ulcers. The data of 215 patients, who underwent endovascular therapy from January 2016 to May 2020 at our center, were retrospectively reviewed. Patients were divided into the P0, P1, and P2 groups according to the angiography results. The rates of ulcer healing, limb salvage, survival, and amputation-free survival were compared during the 2-year period after discharge. Of the 216 affected limbs, 35 (16%) were classed as P0, 122 (57%) as P1, and 59 (27%) as P2. Compared with the P2 group, the P0+P1 group had a higher ulcer healing rate (P=0.001), a shorter ulcer healing time (P=0.004), and a higher survival rate (P=0.044). GLASS IM Modifier classification P2 was an independent predictor of nonhealing ulcers. No significant difference was observed between the P0 versus P1 groups. GLASS IM modifier classification P2 is an independent risk factor for a poor outcome. GLASS IM modifier classification P0 versus P1 demonstrates similar outcomes to each other.

Rotational atherectomy for below the knee lesions in critical limb threatening ischemia: Is it a wild goose chase?

Aim: Treatment of infrapopliteal peripheral arterial disease is still challenging. Rotational atherectomy (RA) is a novel option that aims removal of calcium from the lumen and improvement in outcomes. Material and Methods: Data of 27 patients (19 males, 8 females; mean age: 59.8±13.7 years; range, 25 to 79 years) with infrapopliteal occlusions treated by RA between January 2017 and December 2019 was retrospectively collected. The Global Limb Anatomic Staging System (GLASS) and the Rutherford classification (RC) were used for evaluation. The objective performance goals of Conte et al. (major adverse limb event [MALE] and major adverse cardiovascular event [MACE]) were used for assessing outcome performance. Visits were scheduled at 1, 6, 12, 18, and 24 months after treatment. In each visit, symptoms, RC, wound status, smoking status, lifestyle modifications, and medications were questioned, laboratory tests and Doppler ultrasonography were carried out, and the next visit was planned. Results: Device success was 88.89%, whereas procedural success was 100%. Unanticipated amputation rate was 11.1% in the 12-month follow-up. Over half of the patients (66.67%) showed RC improvement with a mean change of 3±1.17. Thirty-day safety endpoints were as follows: MALE, MACE, and amputation rates were 12.5%, 0%, and 8.33%, respectively. One-year efficacy endpoints were as follows: freedom from MALE+perioperative death was 71.42%, amputation-free survival was 76.19%, freedom from reintervention (amputation was 75%, limb salvage was 80%, and survival was 90.47%. Associations between RC (5-6) and calcification, chronic renal insufficiency and amputation, being a nonsmoker and failure to improve RC, and smoking and high infrapopliteal GLASS were found. Smoking cessation came with RC improvement in every case. Nonquitters experienced worsening more often compared to quitters (0% vs. 25%). Conclusion: Rotational atherectomy is feasible and effective in infrapopliteal chronic total occlusions. Closer follow-up is suggested for nonsmokers and patients with chronic renal insufficiency or advanced GLASS stages as they are prone to unfavorable clinical results. Quitting smoking should be underlined with its potential positive clinical effect even after the procedure.