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BACKGROUND: To assess the quality of clinical practice guidelines (CPGs) for chronic limb-threatening ischemia (CLTI) using the Appraisal of Guidelines for Research and Evaluation II instrument.
METHODS: A systematic review of Medline, Embase, and online CPG databases was carried out. Four CPGs on CLTI were identified: Global Vascular Guidelines (GVG), European Society of Cardiology (ESC), American College of Cardiology, and National Institute for Health and Care Excellence guidelines on lower limb peripheral arterial disease. Two independent appraisers analyzed the 4 CPGs using the Appraisal of Guidelines for Research and Evaluation II instrument. CPGs were ranked across 6 domains with 23 items that ranged from 1 (strongly disagree) to 7 (strongly agree). A scaled domain score was calculated as a percentage of the maximum possible score achievable. A domain score of ≥50% and an overall average domain score of ≥80% reflected a CPG of adequate quality recommended for use.
RESULTS: GVG had the highest overall score (82.9%), as an average of all domains, and ESC had the lowest score (50.2%). GVG and National Institute for Health and Care Excellence guidelines had all domains scoring >50%, while American College of Cardiology had 5 and ESC had 3. Two domains, rigor of development and applicability, scored the lowest among the CPGs. There was a lack of detail in describing systematic methods used in the literature review, how guidelines were formulated with minimal bias, and the planned procedure for updating the guidelines. Implications of guideline application and monitoring of outcomes after implementations were not explicitly discussed.
CONCLUSIONS: The GVG guideline published in 2019 discussing CLTI is assessed to be of high quality and recommended for use. This review helps to improve clinical decision-making and quality of future CPGs for CLTI.

UNASSIGNED: In 2022, the National Health Service Commissioning for Quality and Innovation (CQUIN) indicator for vascular surgery, with its pay-for-performance incentive for timely (5-day) revascularization of chronic limb-threatening ischemia (CLTI), was introduced. We sought to assess its effects in terms of (1) changes in the care pathway process measures relating to timing and patient outcomes; and (2) adherence to the Peripheral Arterial Disease Quality Improvement Framework (PAD-QIF) guidelines for patients admitted with CLTI.
UNASSIGNED: A retrospective before-and-after cohort study was performed from January to June 2022 of nonelective admissions for CLTI who underwent revascularization (open, endovascular, or hybrid) at Cambridge University Hospitals National Health Service Foundation Trust, a regional vascular \"hub.\" The diagnostic and treatment pathway timing-related process measures recommended in the PAD-QIF were compared between two 3-month cohorts-before vs after introduction of the CQUIN.
UNASSIGNED: For the two cohorts (before vs after CQUIN), 17 of 223 and 17 of 219 total admissions met the inclusion criteria, respectively. After introduction of financial incentives, the percentage of patients meeting the 5-day targets for revascularization increased from 41.2% to 58.8% (P = .049). Improvements were also realized in the attainment of PAD-QIF targets for a referral-to-admission time of ≤2 days (from 82.4% to 88.8%; P = .525) and admission-to-specialist-review time of ≤14 hours (from 58.8% to 76.5%; P = .139). An increase also occurred in the percentage of patients receiving imaging studies within 2 days of referral (from 58.8% to 70.6%; P = .324). The reasons for delay included operating list pressures and unsuitability for intervention (eg, active COVID-19 [coronavirus disease 2019] infection). No statistically significant changes to patient outcomes were observed between the two cohorts in terms of complications (pre-CQUIN, 23.5%; post-CQUIN, 41.2%; P = .086), length of stay (pre-QUIN, 12.0 ± 12.0 days; post-QUIN, 15.0 ± 21.0 days; P = .178), and in-hospital mortality (pre-QUIN, 0%; post-QUIN, 5.9%). Other PAD-QIF targets relating to delivery of care were poorly documented for both cohorts. These included documented staging of limb threat severity with the WIfI (wound, ischemia, foot infection) score (2.9% of patients; target >80%), documented shared decision-making (47.1%; target >80%), documented issuance of written information to patient (5.9%; target 100%), and geriatric assessment (6.3%; target >80%).
UNASSIGNED: The pay-for-performance incentive CQUIN indicators appear to have raised the profile for the need for early revascularization to treat CLTI, engaging senior hospital management, and reducing the time to revascularization in our cohort. Further data collection is required to detect any resultant changes in patient outcomes. Documentation of guideline targets for delivery of care was often poor and should be improved.

BACKGROUND: 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).
METHODS: 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.
RESULTS: 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).
CONCLUSIONS: 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.

The 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).
We 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.
We 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).
Bypass 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.

BACKGROUND: 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.
METHODS: 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.
RESULTS: 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 ± 2.40 years. 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).
CONCLUSIONS: 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.

OBJECTIVE: This study aimed to investigate the long-term impact of guideline-directed medical therapy (GDMT) on 10-year mortality in patients with chronic limb-threatening ischaemia (CLTI) after revascularization.
METHODS: We performed a retrospective multicentre study enrolle 459 patients with CLTI who underwent revascularization (396 endovascular therapy [EVT] and 63 bypass surgery [BSX] cases) between January 2007 and December 2011. The primary outcome measure was all-cause mortality. We additionally explored the predictors for all-cause mortality using Cox regression hazard models; the influence of GDMT, defined as prescription of antiplatelet agents, statins, and angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) in aggregate, on all-cause mortality, and the association between baseline characteristics using interaction effects.
RESULTS: During the 10-year follow-up after revascularization, 234 patients died. In Kaplan-Meier analysis, 10-year mortality was significantly lower in patients who received statins (p＜.001) and ACE inhibitors or ARBs (p=.010) than those who did not. However, there were no differences in 10-year mortality between patients who received anti-platelet agents and those who did not (p=.62). Interaction analysis revealed that GDMT had a significantly different hazard ratio in patients who were and were not on hemodialysis and in those treated with EVT or BSX (p for interaction =.002 and .044, respectively). In the multivariate analysis, age ＞75 years, non-ambulatory status, hemodialysis, congestive heart failure, left ventricular ejection fraction ＜50%, and GDMT were significantly associated with all-cause mortality.
CONCLUSIONS: Appropriate GDMT use was independently associated with 10-year mortality in patients with CLTI after revascularization.

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, 77 years; 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 30 days. The whole cohort has a follow-up rate of 96% over a mean of 28 ± 26 months, 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.

Minority patients such as Blacks, Hispanics, and Native Americans are disproportionately impacted by critical limb ischemia and amputation due to multiple factors such as socioeconomic status, type or lack of insurance, lack of access to health care, capacity and expertise of local hospitals, prevalence of diabetes, and unconscious bias. The Society of Interventional Radiology Foundation recognizes that it is imperative to close the disparity gaps and funded a Research Consensus Panel to prioritize a research agenda. The following research priorities were ultimately prioritized: (a) randomized controlled trial with peripheral arterial disease screening of at-risk patients with oversampling of high-risk racial groups, (b) prospective trial with the introduction of an intervention to alter a social determinant of health, and (c) a prospective trial with the implementation of an algorithm that requires criteria be met prior to an amputation. This article presents the proceedings and recommendations from the panel.

OBJECTIVE: The Global Vascular Guidelines (GVG) propose a novel Global Anatomic Staging System (GLASS) with the Wound, Ischemia, and foot Infection (WIfI) classification system as a clinical decision-making tool for interventions in chronic limb-threatening ischemia (CLTI). We assessed the validity of clinical staging and the relationship between the treatments recommended by the GVG and the outcomes of the actual procedures.
METHODS: This retrospective, single-center, observational study included 117 patients with CLTI undergoing infrainguinal revascularization in our hospital between 2015 and 2019. Of those patients, 55 underwent open bypass (OB) and 62 underwent endovascular revascularization (EVR). Femoropopliteal, infrapopliteal, and inframalleolar GLASS grades were assigned based on angiographic images. These grades were combined to determine the revascularization strategy recommended by the GVG: \"endovascular,\" \"indeterminate,\" and \"open bypass.\" The indeterminate category includes three subcategories: GLASS stage III, WIfI stage 2; GLASS stage II, WIfI stage 3; and GLASS stage II, WIfI stage 4. For the purposes of this study, we labeled these subcategories A, B, and C, respectively. The primary outcome was the correlation between the revascularization strategies recommended by the GVG and the actual procedures performed. The relationships between the actual procedures and overall survival, limb salvage, and patency were also examined.
RESULTS: The femoropopliteal and infrapopliteal GLASS grades were higher in the OB group. EVR was performed more often for GLASS stages I and II and was more often classified as indeterminate B and C, whereas OB was performed more often in GLASS stage III and was more often classified as indeterminate A. There were no statistically significant differences in the inframalleolar/pedal disease descriptor or in the 30-day postoperative complication rates between the two groups. In higher GLASS stages, the technical success rate of EVR was lower, and lesion complexity was more severe. Patients for whom the recommended strategy according to the GVG would have been OB but who underwent EVR were associated with low limb salvage and patency rates.
CONCLUSIONS: The GVG provide good guidance for the selection of the revascularization strategy. When the GVG indicate OB, it should be the treatment of choice, rather than EVR, for patients who are fit to undergo the procedure.