Major Amputation Rate Research Articles

Total Contact Casting Remains an Effective Modality for Treatment of Diabetic Foot Ulcers.

Total contact casting (TCC) is used to promote wound closure in diabetic foot ulcers (DFUs); however, this technique is underused today. This study aims to further evaluate the efficacy of TCC in a large cohort, including patients with peripheral artery disease (PAD). This was a retrospective analysis of patients with DFUs who underwent TCC from 2017 to 2021. PAD was defined as absence of pedal pulse or ABI <0.9. Demographic data, DFU characteristics, and peripheral arterial intervention were evaluated. Outcomes included complete healing, healing time, and rate of major amputation. Subgroup analysis was performed on patients undergoing peripheral intervention. 152 patients underwent TCC. Mean age was 58.8 ± 12.1years, 79.6% were male, and 26.3% had PAD. Mean DFU size was 8.27 ± 9.9cm2, with mean depth 0.61 ± 0.49cm. 112 patients had palpable pedal pulses on the affected extremity (73.7%). Average ABI was 1.12 ± 0.22 (n = 90). Complete healing was observed in 122 (80.3%) patients, with average healing time of 81.5 ± 57.1days. Thirteen (8.6%) patients eventually required amputation (3 major). When compared to patients with healed DFUs, those without healing had higher rates of amputation (39.1% vs 3.1%, P < .001), intervention (43.4% vs 17.8%, P = .006), and noncompliance (39.1% vs 20.2%, P = .046). Thirty-three patients underwent revascularization, undergoing angioplasty (81.8%), atherectomy (63.6%), stent (15.2%), and/or bypass (9.1%). Interventions were performed in aortoiliac (3.0%), femoropopliteal (45.5%), and tibial (72.7%) segments. Twenty-two (66.7%) patients who underwent revascularization completely healed. Patients requiring revascularization were more likely to have previous intervention (57.6% vs 13.4%, P < .0001) and incompressible vessels (36.4% vs 7.6%, P < .00001), with lower ABIs (0.94 ± 0.25 vs 1.17 ± 0.18, P = .0008) compared to patients without intervention. TCC remains an effective option for treatment of DFUs, as most were completely healed. Patients with PAD may benefit from TCC and revascularization, however, healing rates are lower in this cohort, necessitating the need for close observation.

Amputation-Free Survival, WIfI Stage, and GLASS Classifications in Distal Crural or Pedal Bypass for Chronic Limb-Threatening Ischemia

Background: Chronic limb-threatening ischemia (CLTI) is a severe condition with high risks of amputation and mortality, especially in patients with distal crural or pedal artery disease. Despite advances in endovascular techniques, bypass surgery remains crucial for patients with CLTI. This study aimed to investigate amputation-free survival, Wound, Ischemia, and foot Infection (WIfI) staging, and Global Limb Anatomic Staging System (GLASS) classifications in patients undergoing distal crural or pedal bypass for CLTI. Methods: This retrospective study analyzed all patients who underwent distal crural or pedal bypass for CLTI in a tertiary vascular centre from January 2010 to December 2019. The data were collected from hospital records and preoperative imaging. WIfI stages and GLASS classifications were determined for each patient, and the primary endpoint was amputation-free survival. Secondary outcomes included bypass patency, 30-day morbidity, and mortality. Results: We identified 31 bypasses performed on 29 patients with a median age of 67 years (79% male). Preoperatively, 94% of limbs were staged GLASS III and 55% were classified WIfI stage 4. Failed endovascular revascularization preceded bypass surgery in 65% of the cases. Thirty-day mortality was 3% (n = 1) and 30-day major amputation rate was 10%. Primary patency was 87%, and secondary patency was 94% at 30 days. Median duration of follow-up for survival was 59 months with a mean follow-up index (FUI) of 0.99 ± 0.05, and for major amputation and bypass patency 54 months (mean FUI 0.9 ± 0.19 and 0.85 ± 0.28, respectively). At one year, amputation-free survival was 58%, decreasing to 45% at two years, 39% at three years, and 32% at five years. Most major amputations occurred in WIfI stage 4 patients, but 53% of WIfI stage 4 and 80% of WIfI stage 3 patients were alive without major amputation after one year. Conclusions: Distal crural and pedal bypasses are essential for limb salvage in high-risk CLTI patients, particularly those with failed prior revascularization. However, the procedure is associated with limited long-term amputation-free survival. WIfI and GLASS classifications are useful for stratifying risk and guiding treatment, but outcomes suggest the need for individualized care strategies. Further research into perioperative management and alternative interventions is warranted to improve long-term outcomes in this population.

Impact of the Affordable Care Act on Revascularization Versus Amputation in Patients Presenting With Chronic Limb-Threatening Ischemia in Maryland.

The Affordable Care Act (ACA) aimed to expand Medicaid, enhance health care quality and efficiency, and address health disparities. These goals have potentially influenced medical care, notably revascularization rates in patients presenting with chronic limb-threatening ischemia (CLTI). This study examines the effect of the ACA on revascularization vs amputation rates in patients presenting with CTLI in Maryland. This was a retrospective analysis of the Maryland State Inpatient Database comparing the rate of revascularization to rate of major amputation in patients presenting with CLTI over 2 periods: pre-ACA (2007-2009) and post-ACA (2018-2020). In this study, we included patients presenting with CLTI and underwent a major amputation or revascularization during that same admission. Using regression analysis, we estimated the odds of revascularization vs amputation pre- and post-ACA implementation, adjusting for pertinent variables. During the study period, 12,131 CLTI patients were treated. Post-ACA, revascularization rate increased from 43.9% to 77.4% among patients presenting with CLTI. This was associated with a concomitant decrease in the proportion of CLTI patients undergoing major amputation from 56.1% to 22.6%. In the multivariate analysis, there was a 4-fold odds of revascularization among patients with CLTI compared to amputation (OR = 4.73, 95% CI 4.34-5.16) post-ACA. This pattern was seen across all insurance groups. The post-ACA period in Maryland was associated with an increased revascularization rate for patients presenting with CLTI with overall benefits across all insurance types.

Factors affecting in-hospital clinical outcomes in patients with acute limb ischemia undergoing endovascular therapy or fogarty thrombectomy: a large-scale analysis based on the JROAD-DPC database

Abstract Background The etiology of acute limb ischemia (ALI) involves embolism as well as atherosclerotic thrombosis. Although endovascular therapy (EVT) or Fogarty thrombectomy (Fogarty TE) is the recommended revascularization method for ALI, treatment choice based on patient characteristics remains controversial. Purpose This study aimed to evaluate the differences in clinical outcomes between primary treatments and identify predictive factors affecting clinical outcomes in patients with ALI. Methods This retrospective study used data from the Japanese Registry of All Cardiac and Vascular Diseases-Diagnosis Procedure Combination (JROAD-DPC) database, from April 2012 to March 2020. We analyzed 18,701 patients with ALI and categorized them into medication and invasive treatment groups (EVT alone, Fogarty TE alone, bypass surgery alone, and hybrid treatment). The EVT-alone and Fogarty TE-alone groups were compared after propensity score matching, considering 19 clinically relevant covariates. The primary outcomes were in-hospital mortality, major amputation, and bleeding complications (anemia requiring transfusion or endoscopic hemostasis). The secondary outcomes were major adverse cardiovascular events (myocardial infarction, coronary intervention, heart failure, stroke, and cerebral hemorrhage), major amputation and/or death, hospitalization duration, and total cost during hospitalization. Results The EVT-alone group had more patients at a higher risk of atherosclerotic disease, including peripheral artery disease (PAD), chronic kidney disease (CKD), or hemodialysis. The Fogarty TE-alone group had more patients at a higher risk of embolism, including AF or AFL. After propensity score matching, in-hospital mortality (odds ratio [OR]: 1.58, 95% confidence interval [CI]: 1.29–1.92, p&amp;lt;.0001), bleeding complications (OR: 1.28, 95% CI: 1.12–1.46, p=0.0002), and major amputation rates (OR: 1.44, 95% CI: 1.17–1.76, p=0.0004) were significantly higher in the EVT-alone group than in the Fogarty TE-alone group. Major amputation and/or death rates and total hospitalization costs were higher in the EVT-alone group than in the Fogarty TE-alone group. In interaction analyses, EVT demonstrated a favorable trend of lower risks of death and/or major amputation in patients with PAD, CKD, and diabetes mellitus (all risk factors for atherosclerotic disease), especially in those with PAD and CKD. Conclusions Fogarty TE may be the preferred primary treatment for patients with ALI, particularly those without PAD or CKD.Study flowchartForest plot analyzing interaction effect

Exploring the Other Side of the River: Early and Midterm Outcomes of Endovascular Pedal Arch Revascularization in Patients with Chronic Limb-Threatening Ischemia.

This study investigated the effect of patency of the pedal arch (PA) on wound healing rate and time, amputation-free survival (AFS), limb salvage, and limb-based patency (LBP) in chronic limb-threatening ischemia (CLTI) patients undergoing endovascular revascularization of infrainguinal arterial lesions. This prospective study included all CLTI patients presenting with wound, ischemia, and foot infection (WIfI) stages 2 to 4 (WIfI ischemia grades 2-3) who underwent endovascular revascularization of infrainguinal arterial disease between April 2019 and April 2021. Pedal angioplasty was attempted in all patients with significant steno-occlusive pedal artery disease. Patients were stratified according to Kawarada PA types. Successful PA revascularization (PAR) was counted when at least 1 pedal vessel is patent. Wound healing rate and time and Kaplan-Meier estimate of AFS and LBP at 2 years were evaluated and compared among the patient groups. A total of 120 patients were categorized according to PA type into type 1 (n = 34; 28.3%), type 2 (n = 64; 53.3%), and type 3 (n = 22; 18.3%). Pedal angioplasty was attempted in 97 patients and was technically successful in 75 patients (77.3%). Successful PAR (with or without pedal angioplasty) was achieved in 98 patients (81.7%). During the follow-up, successful PAR resulted in a better wound healing rate (86.7% vs 59.1%; P = 0.007), major amputation rates (5.1% vs 40.9%; P ≤ 0.001), and AFS (92.9% vs 72.7%; P = 0.018) compared with unsuccessful PAR. There were no significant differences between the 2 groups in wound healing time (3.76 ± 1.99 months vs 3.64 ± 1.94 months; P = 0.798, respectively) or LBP (80.6% vs 72.7%; P = 0.594, respectively). Global Limb Anatomic Staging System (GLASS) stage (odds ratio [OR] = 6.84; 95% CI, 1.30-36.03; P = 0.023) and unsuccessful PAR (OR = 21.64; 95% CI, 4.01-116.69; P ≤ 0.001) were independently associated with failure of wound healing, whereas site of wound lesion (OR = 5.52; 95% CI, 1.15-26.48; P = 0.033), GLASS stage (OR = 24.93; 95% CI, 2.84-218.69; P = 0.004), and unsuccessful PAR (OR = 22.44; 95% CI, 3.53-142.67; P = 0.001) were significant predictors of major amputation. Successful PAR is important for improving clinical outcomes of endovascular revascularization of CLTI patients such as wound healing, amputation-free survival, and limb salvage. Predictors of limb salvage were site of foot lesion, GLASS stage, and successful PAR, whereas GLASS stage and successful PAR were independently associated with improved wound healing. Pedal arch patency positively influences clinical outcomes in patients with chronic limb-threatening ischemia who have ischemic wounds undergoing endovascular revascularization. This study demonstrated that successful pedal arch revascularization (PAR) significantly improved wound healing, amputation-free survival, and limb salvage rates when compared to patients who did not achieve successful PAR. Additionally, the study identified the predictors of limb salvage as the site of foot lesions, GLASS staging, and successful PAR, while both GLASS staging and successful PAR were found to be independently associated with improved wound healing.

Lesion Localization and Limb Outcomes in Elderly Patients with and Without Type 2 Diabetes Mellitus Who Undergo Atherectomy-Assisted Endovascular Revascularization due to Symptomatic Peripheral Artery Disease.

Background/Objectives: Type 2 diabetes mellitus (T2DM) represents a major risk factor for peripheral artery disease (PAD). We aimed to evaluate the impact of T2DM on lesion localization and complexity, clinical presentation by Rutherford categories, and limb outcomes in elderly patients with symptomatic PAD undergoing endovascular revascularization. Methods: Five hundred consecutive patients with symptomatic infra-inguinal PAD who underwent rotational atherectomy-assisted endovascular revascularization were included. PAD clinical presentation and lesion localization were recorded. The primary endpoints were clinically driven target lesion revascularization (CD-TLR) and major amputation rates during follow-up. Results: Overall, 245/500 (49.0%) patients had T2DM, whereas 179 (35.8%) presented with lifestyle limiting claudication and 321 (64.2%) with critical limb-threatening ischemia (CLTI). Median age was 78.0 (IQR = 70.0-84.0) years, and 201 (40.2%) patients were female. The presence of T2DM was significantly more frequent in patients with CLTI vs. those with claudication (58.6 vs. 31.8%; p < 0.001). Furthermore, the percentage of patients with below-the-knee (BTK) lesions was significantly higher in patients with vs. without T2DM (40.7 vs. 27.5%, p = 0.0002). During median follow-up of 21.9 (IQR = 12.8-28.8) months, CD-TLR rates were similar in patients with vs. without T2DM (HR = 1.2, 95%CI = 0.8-2.0, p = 0.39). However, patients with T2DM had a ~5.5-fold increased risk for major above-the-ankle amputation (HR = 5.5, 95%CI = 1.6-19.0, p = 0.007). After adjustment for age, gender, lesion complexity, and calcification, T2DM remained predictive for major amputation (p = 0.04). Conclusions: T2DM is more frequently associated with CLTI, BTK-PAD, and amputations despite successful endovascular revascularization. More stringent surveillance of patients with PAD and T2DM is warranted to prevent atherosclerosis-related complications.

Polymer Everolimus-Eluting Stent as Bailout Stenting for Below-the-Knee Artery Repair in Patients with Critical Limb-Threatening Ischemia: A Real-World National Registry.

Percutaneous old balloon angioplasty is still the preferred treatment for the treatment of below-the-knee (BTK) arteries in chronic limb-threatening ischemia (CLTI). In the case of a suboptimal angioplasty result, a bailout stenting is required. So far, few data are available to assess the outcomes of bailout stenting after BTK angioplasty. This study aims to investigate the 1-year efficacy and safety after implantation of a polymer everolimus-eluting stent (PEES) as bailout stenting for BTK repair in patients with CLTI in a real-world setting. This was a national multicenter prospective observational study. Patients with CLTI (Rutherford 4 to 6) BTK lesions (including P3) and requiring a bailout PEES due to dissection, thrombosis, or residual stenosis ≥30% after angioplasty were included. The freedom of a major adverse limb event at 12 months of the target limb was the primary endpoint. XIENCE assessed 106 limbs (CLTI, 96.2%; chronic total occlusion, 2.8%) in 106 patients (mean age 77.1 years; males, 71.7%; diabetes mellitus, 66.9%; chronic kidney failure, 36.8%) with CLTI undergoing PEES stenting as a bailout for BTK lesions. Bailout stenting was required after 75.5% and 26.4% of residual stenosis and dissection, respectively. The mean diameter and length of the PEES were 3 mm and 3.4 ± 0.5 cm, respectively. At 1 year, the freedom of a major adverse limb event was 79.6% (95% CI, 71.5%-88.7%), the major amputation rate was 6.2% (95% CI, 1.3%-11%), and the target revascularization rate was 14.9% (95% CI, 6.5%-22.5%). In CLTI patients with BTK lesions, PEES stenting showed safety and efficacy as bailout stenting for BTK arterial lesions. This confirms the need for PEES stenting in a real-world practice. The XIENCE study introduces the PEES as an effective bailout stenting option for patients with CLTI undergoing BTK revascularization, particularly for lesions under 4 cm. The study focuses on real-world cases where POBA alone is insufficient, demonstrating that PEES significantly improves outcomes by enhancing limb salvage and reducing the need for major amputations. For clinicians, this innovation offers a precise, size-adaptable solution, especially in cases where bailout stenting is required for short, focal lesions, improving both clinical and procedural results.

Machine Learning Algorithm-Aided Determination of Predictors of Mortality from Diabetic Foot Sepsis at a Regional Hospital in South Africa During the COVID-19 Pandemic.

Background and Objectives: Diabetic foot sepsis (DFS) accounts for approximately 60% of hospital admissions in patients with diabetes mellitus (DM). Individuals with DM are at risk of severe COVID-19. This study investigated factors associated with major amputation and mortality in patients admitted with DFS during the COVID-19 pandemic. Materials and Methods: Demographic information, COVID-19 and HIV status, clinical findings, laboratory results, treatment and outcome from records of patients with diabetic foot sepsis, were collected and analysed. Supervised machine learning algorithms were used to compare their ability to predict mortality due to diabetic foot sepsis. Results: Overall, 114 records were found and 57.9% (66/114) were of male patients. The mean age of the patients was 55.7 (14) years and 47.4% (54/114) and 36% (41/114) tested positive for COVID-19 and HIV, respectively. The median c-reactive protein was 168 mg/dl, urea 7.8 mmol/L and creatinine 92 µmol/L. The mean potassium level was 4.8 ± 0.9 mmol, and glycosylated haemoglobin 11.2 ± 3%. The main outcomes included major amputation in 69.3% (79/114) and mortality of 37.7% (43/114) died. AI. The levels of potassium, urea, creatinine and HbA1c were significantly higher in the deceased. Conclusions: The COVID-19 pandemic led to an increase in the rate of major amputation and mortality in patients with DFS. The in-hospital mortality was higher in patients above 60 years of age who tested positive for COVID-19. The Random Forest algorithm of ML can be highly effective in predicting major amputation and death in patients with DFS.

Meta-Analysis of Randomised Controlled Trials Comparing Bypass and Endovascular Revascularisation for Peripheral Artery Disease.

Peripheral artery disease affects approximately 250 million people globally. Multiple randomised controlled trials have compared bypass and endovascular interventions but the optimum revascularisation approach remains unclear. The recently published BEST-CLI and BASIL-2 trials provide current and robust data addressing this question, however their findings are not concordant. This systematic review and meta-analysis provides an overview of the worldwide randomised evidence comparing bypass surgery and endovascular revascularisation in lower limb peripheral artery disease. A comprehensive literature search of MEDLINE, Embase and CENTRAL databases was performed of all time periods up to 7 May 2023 to identify randomised controlled trials comparing bypass and endovascular revascularisation for treating lower limb peripheral artery disease. The primary outcome was major amputation. Secondary outcomes were mortality, re-intervention, 30-day adverse events and 30-day mortality. Odds ratios were calculated and pooled using the random-effects model. Risk of bias was assessed using the Cochrane risk of bias 2 tool. Fourteen cohorts were identified across thirteen studies, enrolling 3840 patients. There was no significant difference in major amputation (OR 1.12; 95% CI 0.80-1.57) or mortality (OR 0.96; 95% CI 0.79-1.17) between the bypass and endovascular groups. Bypass was associated with a significant reduction in re-intervention compared with endovascular treatment (OR 0.57, 95% CI 0.40-0.82). These findings suggest that rates of major amputation and mortality are similar following bypass and endovascular interventions. Patients who undergo bypass surgery have a significantly lower re-intervention rate post-operatively.

Percutaneous Deep Venous Arterialization by Balloon Angioplasty without Stent Implantation for Patients with Chronic Limb-Threatening Ischemia Undergoing Hemodialysis: A Retrospective Cohort, Single-Center, Single-Arm Study.

This retrospective, single-center study aimed to determine the efficacy of percutaneous deep venous arterialization in patients on hemodialysis with chronic limb-threatening ischemia. Twenty-one consecutive limbs on hemodialysis with chronic limb-threatening ischemia were treated with percutaneous deep venous arterialization using balloon angioplasty following a failed pedal arterial reconstruction between May 2021 and June 2022. An arteriovenous fistula near the ankle joint was created to ensure sufficient venous flow reversal to the pedal veins. In case of occlusion of the tibial artery, a guidewire was advanced (subintimal) to the ankle joint vicinity was technically important. The primary outcome measures were the 6-month complete wound healing and freedom from major amputation rates; the secondary outcome measure was the 6-month amputation-free survival. Occlusion of all pedal arteries was observed in 17 limbs (81.0%). Arteriovenous fistulas were predominantly created at the distal portions of the posterior tibial artery and vein in 18 limbs (85.7%). No extravasation at the fistulas was observed. Re-intervention was required in 16 limbs (76.2%) due to tibial artery or deep vein occlusion. The 6-month complete wound healing rate was 42.9% (nine limbs), with a median healing time of 85 days (interquartile range: 58-151 days). The 6-month freedom from major amputation and amputation-free survival rates were 90.5% (19 limbs) and 61.9% (13 limbs), respectively. Balloon angioplasty without stent implantation for percutaneous deep venous arterialization is promising for improving the complete wound healing and amputation-free survival rates after pedal artery reconstruction failure. Level 3b, retrospective cohort study.

Outcomes after endovascular revascularization for chronic limb-threatening ischemia from the only Vascular Quality Initiative (VQI) center in Asia

ObjectiveThis study compares chronic limb-threatening ischemia disease characteristics and endovascular revascularization outcomes in a multi-ethnic Asian cohort vs their North American counterparts. MethodsThe Society for Vascular Surgery Vascular Quality Initiative (VQI) registry database from the first and currently the only VQI center in Asia was reviewed to identify patients with chronic limb-threatening ischemia who underwent endovascular revascularization between July 2019 and April 2024. Standardized VQI reporting variables were compared against benchmarks derived from all participating centers in North America. ResultsA total of 2862 endovascular revascularization procedures from our center were benchmarked against 129,347 procedures from 406 North American centers. Our cohort had a higher burden of comorbidities (diabetes mellitus, end-stage renal disease, cardiac disease) and presented with more advanced Wound, Ischemia, and foot Infection stages. Our patients had more heavily calcified and longer (14.8 cm vs 6.0 cm) diseased vessels with higher prevalence of multi-level (87% vs 54.6%), infrapopliteal (52.6% vs 38.9%), and inframalleolar (9.6% vs 2.4%) disease. Rates of technical success (92.7% vs 93%) and symptom improvement (39.1% vs 40.4%) were comparable between cohorts. However, 1-year mortality rates (28.9% vs 25.1%) and major amputation rates (13.3% vs 7.8%) were significantly higher. ConclusionsShort-term outcomes of technical success and symptom relief in our center were comparable to benchmarked North American outcomes despite having a cohort with more diseased vessels, higher Wound, Ischemia, and foot Infection stages, and more comorbidities. However, this cohort fared worse in longer term outcomes of 1-year mortality and major amputation rates. Further studies are required to elucidate the causes to improve these outcomes.

Popliteal-Distal Bypass Affords Better Limb Salvage than Tibial Angioplasty for Chronic Limb-Threatening Ischemia

ObjectiveChronic limb-threatening ischemia (CLTI) due to isolated tibial occlusive disease is treated by either popliteal distal bypass or tibial angioplasty, although there is limited data directly comparing efficacy and outcomes between these two treatment modalities. This study compares 30-day mortality and major adverse limb events following infrapopliteal bypass and tibial angioplasty in patients with CLTI. MethodsPatients who underwent popliteal distal bypass for CLTI were extracted from American College of Surgeons National Surgical Quality Improvement Program targeted lower extremity open database, whereas patient with CLTI who underwent isolated tibial angioplasty were identified in the targeted lower extremity endovascular database. Any case with more proximal angioplasty such as femoral/pop/iliac was excluded. The time interval was 2011-2022. The two groups were comparable in demographics and pre-operative comorbidities were obtained using propensity matching. Mortality, systemic complications, and major adverse limb events were measured. Multivariable logistic regression was used for data analysis. To obtain granular data on the angiographic characteristics of patients undergoing popliteal-distal bypass or tibial angioplasty, The George Washington University institutional data from 2014 to 2019 was used as supplement to the database. ResultsThere were 1,947 and 3,423 cases identified in the bypass and endovascular groups, respectively. After propensity matching for all preoperative variables, 1,747 cases remained in each group. Although bypass was associated with higher major adverse cardiovascular events, pulmonary, renal, and wound complications, bypass had significantly better 30-day limb salvage when compared to tibial angioplasty (major amputation rate 3.32% vs. 6.12%; p<0.01). Institutional data identified 69 patients with CLTI due to isolated tibial occlusive disease; 25 (36.2%) underwent popliteal-distal bypass and 44 (63.8%) underwent tibial angioplasty. Reviewing of angiographic details revealed patients who underwent popliteal-distal bypass had better pedal targets (inframalleolar/pedal score of P0 [24.0% vs 15.9%] or P1 [68.0% vs 61.3%]) than tibial angioplasty patients (inframalleolar/pedal score of P2 [22.7% vs 8.0%]). ConclusionPopliteal-distal bypass was associated with higher morbidity but better limb salvage than endovascular interventions. However, this could be explained by the association with better pedal targets in patients who underwent popliteal-tibial bypass. Prospective studies should be done comparing popliteal distal bypasses and tibial angioplasty in cases with similar pedal targets.

Spinal Neuromodulation for Peripheral Arterial Disease of Lower Extremities: A Ten-Year Retrospective Analysis.

This long-term retrospective study evaluated the survival and amputation outcome of subjects who received neuromodulation therapy for the management of peripheral arterial disease (PAD). The study reviews the health data of a single cohort of 51 patients who received spinal neuromodulation (spinal cord stimulation [SCS] or dorsal root ganglion stimulation [DRG-S]) for PAD from 2007 to 2022 in a single German center. Survival rate and major amputation rate were determined. Pain, quality of life, walking distance, and opioid usage were assessed before implantation (baseline), one, six, and 12 months (M) after implantation, and then annually (during a follow-up visit). Implant-related complications also were documented. In total, 51 patients (37 men [mean age 68.9± 10.2 years], 14 women [mean age (68.7± 14.6 years]) underwent SCS (n= 49) or DRG-S (n= 2) implantation owing to persistent ischemic pain. The follow-up mean years± SD is 4.04± 2.73. At baseline, patients were classified as Rutherford's category 3 (n= 23), category 4 (n= 15) or category 5 (n= 9). At 24 M, 42 of 47 patients did not require a major amputation after the implant. All the patients reported nearly complete pain relief from pain at rest. A total of 75% of patients were able to walk >200 m, and 87% of patients who used opioids at baseline were off this medication at 24 M. Overall, 93% of patients reported an improvement in their overall health assessment. These improved outcomes were sustained through years three to 10 for patients who have reported outcomes. Our single-center data support the efficacy of spinal neuromodulation for improvements in limb salvage, pain relief, mobility, and quality of life. The data also show that neuromodulative therapy has a long-term therapeutic effect in patients with chronic limb pain with Rutherford category 3, 4, and 5 PAD.

Female patients have fewer limb amputations compared to male patients in the BEST-CLI trial

ObjectiveFemale patients are less likely to be diagnosed with and treated for peripheral artery disease. When treated, there are also reported sex disparities in short- and long-term outcomes. We designed this study to compare outcomes after open and endovascular revascularization in the Best Endovascular vs best Surgical Therapy in patients with Critical Limb Ischemia (BEST-CLI) trial between females and males, and to examine outcomes of each revascularization type in an all-female cohort. MethodsIn a secondary analysis of cohorts 1 and 2 of the BEST-CLI Trial, patients with chronic limb-threatening ischemia (CLTI) undergoing open surgical bypass (with or without adequate conduit) and endovascular therapy were stratified by sex. In addition, in a female-only cohort, we evaluated differences in outcomes between treatment arm (combined all bypasses from cohorts 1 and 2 and compared with all endovascular treatment in cohorts 1 and 2). Outcomes included major amputation, reintervention, major adverse limb event (MALE, a composite of major amputation and reintervention), all-cause death, and composite outcome of MALE or all-cause death. Univariable and adjusted Cox regressions were used to assess outcome between males and females. Similar methods were used to assess differences in outcomes between treatment arm in females. ResultsAmong 1830 patients, females were significantly underrepresented, comprising only 28% (n = 519) of the BEST-CLI cohort. Overall, the characteristics of females enrolled in the trial had some differences compared with males: females were more likely to have rest pain alone (72% vs 60%; P < .0001) and when presenting with an ischemic wound, were less likely to have a wound infection (38% vs 47%; P = .01). Females were less likely to have an adequate single-segment greater saphenous vein (SSGSV) available (82% vs 89%; P = .01). Controlled for baseline clinical factors, at 1 year, females had significantly lower rates of major limb amputation compared with males (hazard ratio [HR], 0.70; P = .023), which drove better amputation- and MALE-free survival rates. All-cause death at 1 year was not statistically different between sexes (11.8% vs 11.2%; P = .286). In the all-female cohort, results paralleled the overall trial; open surgical bypass (with any conduit) had significantly better outcomes compared with endovascular therapy. Specifically, among females undergoing endovascular therapy, the rate of major reintervention was particularly high compared with females undergoing open surgical bypass (24.8% vs 10.5%; P < .001). ConclusionsDespite being underrepresented in BEST-CLI, the primary results of the trial, namely, improved MALE-free survival with open surgical bypass with SSGSV, were mirrored in the all-female subset. Female patients enrolled in BEST-CLI had better amputation-free survival at 1 year compared with male patients. These findings suggest that in treating female patients with CLTI considered appropriate for both open and endovascular revascularization, surgical bypass with optimal conduit is the preferred treatment option and can potentially ameliorate poor limb preservation outcomes associated with sex.

External validation of the DIAFORA system to predict lower-extremity amputations in a prospective Danish cohort.

A diabetes-related foot ulcer (DFU) is a major risk factor for lower-extremity amputation (LEA). To help clinicians predict the risk of LEA in people with DFU, the Diabetic Foot Risk Assessment (DIAFORA) system was developed but has never been externally validated. In this study, 317 people presenting with a new DFU were included. At baseline, participants were grouped into three groups based on their DIAFORA score: low-risk (<15), medium-risk (15-25), and high-risk (>25). Participants were followed until healing, LEA, death, or at least 3 months. Discriminative accuracy was evaluated using sensitivity, specificity, likelihood ratios (LRs) and the area under the curve (AUC). All 317 participants completed at least 3 months of follow-up for a median duration of 146 days, during which 12.6% underwent minor amputation and 2.5% major amputation. People in the low- and medium-risk categories had major amputation rates of 0.9% and 2.1%, respectively, and negative LR of major LEA of 0.10 and 0.38, respectively, while the people in the high-risk category had an amputation rate of 25.0% and a positive LR of 12.9. The DIAFORA risk groups had a sensitivity of 75.0% and a specificity of 65.7%, with a corresponding AUC of 0.78 (95% CI 0.68-0.87) for the prediction of major LEA. The DIAFORA score is a useful tool for risk stratification of people presenting with a newly occurred DFU, with the external validation presenting results similar to those presented in the original study. The DIAFORA score may guide clinicians towards more individualized DFU treatment regimens.

Temporal Trends and Outcomes of Peripheral Artery Disease and Critical Limb Ischemia in the United States.

Peripheral arterial disease (PAD) is a progressive, systemic atherosclerotic disease that is associated with an increased risk of coronary artery disease (CAD), cerebrovascular disease (CVD), and critical limb ischemia (CLI). CLI represents the most severe stage of PAD, characterized by progressive endothelial dysfunction and arterial narrowing. We hypothesized that the incidence of CLI and PAD would increase over the study period and that the rates of in-hospital mortality and major amputations among patients admitted with CLI would rise correspondingly. We utilized the National Inpatient Sample (NIS) database from year 2016 to 2021 using the ICD-10-CM codes. Patients with a primary or secondary diagnoses of PAD were initially selected and subsequently hospitalization with CLI were appropriately identified. Cochran Armitage test was used to describe the trend of outcomes across the years. All statistical analyses were conducted using the software Stata version 17.0. From 2016-2021, there were 2,930,639 admissions for critical limb ischemia. 65% of these patients were over the age of 60 and 35.8% of these patients were women. Most of these individuals were white (64.7%), followed by African Americans (15.8%) and Hispanics (12.6%). In-hospital mortality rates varied by revascularization method, with hybrid revascularization showing the highest rate at 2.6%, followed by endovascular revascularization at 1.8%, and surgical revascularization at 1.6%. Additionally, hospitalization costs were highest for patients undergoing hybrid revascularization ($46,257 ± $36,417), compared to endovascular ($36,924 ± $27,945) and surgical revascularization ($35,672 ± $27,127). Endovascular revascularization rates seemed to increase while surgical revascularization rates decreased during this time period. PAD is a progressive, systemic atherosclerotic disease that is associated with an increased risk of CAD, CVD, and CLI. Our data showed that the rates of PAD and CLI hospitalizations has remained relatively stable from 2016-2021, but there seems to be a trend towards doing more revascularization via an endovascular approach as compared to a surgical approach.

The Untold Story: Early and Mid-Term Results of Subintimal Angioplasty in Superficial Femoral Artery Versus Popliteal Artery Chronic Total Occlusion.

This study aims to compare the immediate and mid-term outcomes of subintimal angioplasty (SIA) of chronic total occlusions (CTOs) of superficial femoral artery (SFA) versus popliteal artery (PA) and to identify possible predictors of loss of limb-based patency (LBP). This is a retrospective analysis of chronic lower-limb ischemia (CLI) patients (Rutherford classes 3-6) presenting with CTO of SFA or PA treated by SIA and selective stenting in the period 2018 to 2021. Immediate outcomes were compared between the SFA and PA groups, including technical success, perioperative complications, and 30-day major amputation and mortality rates. Mid-term outcomes for technically successful procedures included limb-based patency (LBP), wound healing rate, amputation-free survival (AFS), and major adverse limb events (MALEs). A total of 450 CLI patients underwent SIA of CTO at the SFA (n=260, 57.8%) and the PA (n=190, 42.2%). The indication for revascularization was chronic limb-threatening ischemia in 80.8% of SFA group and 84.2% of PA group. Technical success rate was higher in the PA group compared to the SFA group (96.3% vs 91.2%; p=0.03). The 30-day amputation rates were comparable between the SFA and PA groups (7.7% vs 6.8%, p=0.7, respectively). No perioperative mortality or systemic major complications occurred in the present study. Kaplan-Meier estimate of the 1-year rates were significantly better for SFA group regarding LBP (82% for SFA group vs 43% for PA group, p=0.006), AFS (88% vs 64%, p=0.02), and wound healing (79% vs 58%, p=0.027), respectively. The number of runoff vessels was the only factor associated with loss of LBP (hazard ratio [HR], 0.055; 95% confidence interval [CI]: 0.001-3.020, p=0.039). Subintimal angioplasty is an effective and safe endovascular treatment option of CTO at SFA and PA with satisfactory immediate outcomes. The mid-term outcomes, however, are better for SFA lesions in terms of improved LBP, AFS, and wound healing rates. Subintimal angioplasty is a valuable tool in the armamentarium of endovascular surgeons, as re-entry devices aren't always widely accessible. This study aims to assess the technical outcomes of peripheral vascular interventions for infrainguinal chronic total occlusions and identify possible predictors for successful subintimal angioplasty .Subintimal angioplasty is an effective treatment option for infrainguinal CTO with difference in result of immediate outcomes in popliteal lesions and SFA lesions.

ThP8.1 - Long-Term Impact of COVID-19 related disruption of NHS Elective services on Emergency Major Lower Limb Amputations

Abstract Background The COVID-19 pandemic has affected the healthcare systems worldwide since the dawn of 2020. In March 2020, the United Kingdom government announced the first national lockdown which severely disturbed all NHS healthcare elective services. Our aim is to assess the long-term impact of COVID-19 related disruption of NHS elective services on emergency major lower limb amputations. Method Patients' data for emergency major lower limb amputations (MLLA) for critical limbthreatening ischemia and diabetic foot infections performed at Aberdeen Royal Infirmary was collected through Trakcare® and divided into the control pre-pandemic group (April 2018 to March 2020) and the pandemic group (April 2020 to March 2022). The statistical analysis was conducted using the IBM SPSS software [v28.0.1.1 (14)]. Results A total of 358 patients underwent MLLA and 206 (57.5%) of these had diabetes mellitus. There was a 17% increase in the number of urgent referrals and every one in five of these finally underwent an amputation. There was an increase in the absolute number of Above- and Below-Knee amputations. There was a statistically significant increase by 33% in emergency MLLAs during the pandemic period (p-value &amp;lt;0.05). A total of 165 postoperative deaths up to December 2022 were recorded with 30-day mortality rate of 7.26% (n=26). Conclusion NHS vascular management groups should update themselves with evolving technologies to optimise the care provided during future unprecedented times. Furthermore, more effective measures should also be implemented to avoid delayed presentations, which can potentially lead to higher rates of major limb amputations.

Economic impact of limb-salvage strategies in chronic limb-threatening ischaemia: modelling and budget impact study based on national registry data.

Missed opportunities to reduce numbers of primary major lower-limb amputation and increase limb-salvage procedures when treating chronic limb-threatening ischaemia have previously been identified in the literature. However, the potential economic savings for healthcare providers when salvaging a chronic limb-threatening ischaemia-affected limb have not been well documented. A model using National Health Service healthcare usage and cost data for 1.6 million individuals and averaged numbers of primary surgical procedures for chronic limb-threatening ischaemia from England and Wales in 2019-2021 was created to perform a budget impact analysis. Two scenarios were tested: the averaged national rates of major lower-limb amputation (above the ankle joint), angioplasty, open bypass surgery or arterial endarterectomy in the National Vascular Registry (current scenario); and revascularization rates adjusted based on the lowest amputation rate reported by the National Vascular Registry at the time of the study (hypothetical scenario). The primary outcome was the net impact on costs to the National Health Service over 12 months after the index procedure. In the current scenario, the proportions of different index procedures were 10% for lower-limb major amputation, 55% for angioplasty, 25% for open bypass surgery and 10% for arterial endarterectomy. In the hypothetical scenario, the procedure rates were 3% for major lower-limb amputation, 59% for angioplasty, 27% for open bypass surgery and 11% for arterial endarterectomy. For 16 025 index chronic limb-threatening ischaemia procedures, the total care cost in the current scenario was €243 924 927. In the hypothetical scenario, costs would be reduced for index procedures (-€10 013 814), community care (-€633 943) and major cardiovascular events (-€383 407), and increased for primary care (€59 827), outpatient appointments (€120 050) and subsequent chronic limb-threatening ischaemia-related surgery (€1 179 107). The net saving to the National Health Service would be €9 645 259. A shift away from primary major lower-limb amputation towards revascularization could lead to substantial savings for the National Health Service without major cost increases later in the care pathway, indicating that care decisions taken in hospitals have wider benefits.

Comparison of Clinical Outcomes in Patients with Acute Lower Limb Ischaemia Undergoing Endovascular Therapy and Open Surgical Revascularisation: A Large Scale Analysis in Japan

The recommended revascularisation methods for acute limb ischaemia (ALI), which is caused by embolism and atherosclerotic thrombosis, include endovascular therapy (EVT) and open surgical revascularisation (OSR); however, treatment choices based on patient characteristics remain controversial. This retrospective analysis from the Japanese Registry of All Cardiac and Vascular Diseases - Diagnosis Procedure Combination database (April 2012 to March 2020) evaluated differences in clinical outcomes and identified prognostic predictors in patients with ALI. This study analysed 10 977 patients with lower limb ALI. EVT was defined as catheter directed thrombolysis, percutaneous thrombectomy, or percutaneous angioplasty with balloon dilatation and or stenting. OSR was defined as Fogarty thrombectomy, bypass surgery, or thromboendarterectomy. The EVT and OSR groups were compared after propensity score matching (PSM) considering ten clinical covariates. The EVT group had more patients at higher risk of atherosclerotic disease than the OSR group. The OSR group had more patients at a higher risk of embolism, including atrial fibrillation and atrial flutter, than the EVT group. In the EVT group, 20.4% of patients underwent catheter directed thrombolysis using urokinase, the only thrombolytic agent available in Japan that is covered under insurance. After PSM, in hospital mortality (odds ratio [OR] 1.33, 95% confidence interval [CI] 1.11 - 1.59; p = .002), major amputation rate (OR 1.43, 95% CI 1.19 - 1.72; p < .001), major amputation and or death rate (OR 1.42, 95% CI 1.24 - 1.62; p < .001), and total hospitalisation cost (1.16 vs. 0.97 million yen; p < .001) were statistically significantly higher in the EVT group than in the OSR group. In interaction analyses, peripheral artery disease (PAD) was a factor responsible for reducing OSR efficacy in terms of major amputation and or death rate (with PAD, OR 0.94, 95% CI 0.68 - 1.29; without PAD, OR 1.56, 95% CI 1.34 - 1.82; p = .004). In Japan, EVT was a less effective primary treatment for patients with ALI than OSR, except for those with PAD.