High Risk Of Major Amputation Research Articles

Prognostic value of leukocyte-glycemic index in long-term evolution of diabetic patients with peripheral arterial disease following endovascular treatment

Abstract Objective: The aim of this article is to determine the predictive value of the leukocyte-glycemic index in the long-term evolution of diabetic patients with peripheral arterial disease following endovascular treatment. Methods: This retrospective observational study enrolled 127 diabetic patients diagnosed with peripheral arterial disease requiring endovascular treatment. Patients were categorized into two groups based on the severity of the infrapopliteal atherosclerotic lesions identified during the pre-operative Computer Tomography Angiography examination. Group 1 includes patients without severe damage to the infrapopliteal artery, while Group 2 includes patients with severe infrapopliteal artery damage, identified by stenosis greater than 70% on all infrapopliteal arteries. The primary outcome was to assess the association between leukocyte-glycemic index value at baseline and the severity of infrapopliteal atherosclerotic lesions and long-term major amputation after percutaneous transluminal angioplasty. Results: Patients in Group 2 had a higher incidence of cardiovascular events (p=0.009), stage IV Leriche-Fontaine (p=0.016), and incidence of major amputation (p<0.001), as well as an increased value of leukocyte-glycemic index (p=0.004). During the follow-up, patients with above-median leukocyte-glycemic index value have a higher risk of major amputation (p=0.034), as seen in the Kaplan-Meier analysis. Moreover, at cox-regression, elevated biomarker values were associated with long-term risk of major amputation, independent of age, sex, cardiovascular risk factors, and below-the-knee arterial occlusion (HR:2.69, p=0.001). Conclusions: Elevated values of leukocyte-glycemic index are associated with the severity of infrapopliteal atherosclerotic lesions and major amputation in the long term.

Outcomes and predictors of amputation-free survival in patients undergoing below-knee popliteal-distal bypass

ObjectiveThe infrageniculate popliteal artery is a potential source for inflow in lower extremity bypass surgery in patients with isolated tibial artery disease. The objective of our study was to assess the short- and long-term outcomes of popliteal-distal bypasses using data from the Vascular Quality Initiative (VQI). MethodsThe VQI registry was queried between 2003 and 2021 for patients undergoing surgical revascularizations with the below-knee popliteal artery serving as inflow. Demographics, comorbidities, intraoperative characteristics, and postoperative complications were analyzed. Kaplan-Meier models were used to estimate amputation-free survival, survival, and freedom from amputation. Cox regression analysis was conducted to determine factors associated with major amputation or death. ResultsA total of 1884 procedures were analyzed. The mean age of the included patients was 67.7 years. The most frequently observed preoperative comorbidities included insulin-dependent diabetes (52.3%), coronary disease (32.4%), and end-stage renal disease (14.4%). Of all the patients, 670 (35.6%) had a history of ipsilateral endovascular intervention. The procedures were performed for a variety of indications, including tissue loss (84.3%), rest pain (10.9%), and claudication (4.8%). Intraoperatively, the outflow targets were the dorsalis pedis (31.4%), the posterior tibial (24.4%), and the anterior tibial arteries (15.6%). Vein conduit was used in 92.1% of cases. The rate of perioperative myocardial infarction (MI) was 2.4%, and the 30-day mortality was 1.9%. The median length of follow up was 371 days. Amputation-free survival was found to be 85.6% (95% confidence interval [CI], 84.0%-87.2%) at 6 months and 78.6% (95% CI, 76.6%-80.4%) at 12 months. Survival was found to be 93.4% (95% CI, 92.2%-94.5%) at 6 months and 88.6% (95% CI, 87.1%-90.0%) at 12 months. Freedom from amputation was found to be 92.0% (95% CI, 90.7%-93.3%) at 6 months and 89.0% (95% CI, 87.3%-90.4%) at 12 months. Cox regression analysis demonstrated that age greater than 65 years, congestive heart failure, coronary artery disease, and end-stage renal disease were associated with a higher risk of major amputation or death (P < .05). ConclusionsBelow-knee popliteal-distal bypass is a safe and effective approach to treat severe tibial vessel occlusive disease in this challenging patient cohort. Patients exhibited low perioperative complication rates and good amputation-free survival at 1 year.

Editor's Choice -- Survival, Limb Salvage, and Management of Patients with Lower Limb Acute Ischaemia: A French National Retrospective Observational Study

The aim was to describe the baseline characteristics of French patients referred with acute limb ischaemia (ALI), and their clinical management and outcome (death, amputation). This retrospective observational cohort study used the National Health Data System. All adults hospitalised for ALI who underwent revascularisation with an endovascular or open surgical approach between 1 January 2015 and 31 December 2020 were included and followed up until death or the end of the study (31 December 2021). A one year look back period was used to capture patients' medical history. The risks of death, and major and minor amputations were described using Kaplan-Meier and Aalen-Johansen estimators. A Cox model was used to report the adjusted association between groups and risk of death and Fine-Gray models for the risk of amputations considering the competing risk of death. Overall, 51 390 patients (median age 70 years, 69% male) were included and had a median follow up of 2.7 years: 39 411 (76.7%) were treated with an open approach and 11 979 (23.3%) with a percutaneous endovascular approach. The preferred approach for the revascularisation varied between French regions. The one year overall survival was 78.0% and 85.2% in the surgery and endovascular groups, respectively. The surgery group had a higher risk of death (hazard ratio [HR] 1.17, 95% CI 1.12 - 1.21), a higher risk of major amputation (sub-distribution HR 1.20, 95% CI 1.10 - 1.30) and lower risk of minor amputation (sub-distribution HR 0.66, 95% CI 0.60 - 0.71) than the endovascular group. Diabetes and dialysis increased the risk of major amputation by 52% and 78%, respectively. Subsequent ALI was the third most common cause of hospital re-admission within one year. ALI remains a condition at high risk of death and amputation. Individual risk factors and ALI severity need to be considered to choose between approaches. Continued prevention efforts, improved management, and access to the most suitable approach are necessary.

Outcomes after minor lower limb amputation for peripheral arterial disease and diabetes: population-based cohort study.

Patients with diabetes and peripheral arterial disease are at increased risk of minor amputation. The aim of study was to assess the rate of re-amputations and death after an initial minor amputation, and to identify associated risk factors. Data on all patients aged 40 years and over with diabetes and/or peripheral arterial disease, who underwent minor amputation between January 2014 and December 2018, were extracted from Hospital Episode Statistics. Patients who had bilateral index procedures or an amputation in the 3 years before the study were excluded. Primary outcomes were ipsilateral major amputation and death after the index minor amputation. Secondary outcomes were ipsilateral minor re-amputations, and contralateral minor and major amputations. In this study of 22 118 patients, 16 808 (76.0 per cent) were men and 18 473 (83.5 per cent) had diabetes. At 1 year after minor amputation, the estimated ipsilateral major amputation rate was 10.7 (95 per cent c.i. 10.3 to 11.1) per cent. Factors associated with a higher risk of ipsilateral major amputation included male sex, severe frailty, diagnosis of gangrene, emergency admission, foot amputation (compared with toe amputation), and previous or concurrent revascularization. The estimated mortality rate was 17.2 (16.7 to 17.7) per cent at 1 year and 49.4 (48.6 to 50.1) per cent at 5 years after minor amputation. Older age, severe frailty, comorbidity, gangrene, and emergency admission were associated with a significantly higher mortality risk. Minor amputations were associated with a high risk of major amputation and death. One in 10 patients had an ipsilateral major amputation within the first year after minor amputation and half had died by 5 years.

Cohort Study Examining the Presentation, Distribution, and Outcomes of Peripheral Artery Disease in Aboriginal, Torres Strait Islander, and Non-Indigenous Australians

This retrospective cohort study investigated the anatomical distribution, severity, and outcome of peripheral artery disease (PAD) in Aboriginal and Torres Strait Islander compared with non-Indigenous Australians. The distribution, severity, and outcome of PAD were assessed using a validated angiographic scoring system and review of medical records in a cohort of Aboriginal and Torres Strait Islander and non-Indigenous Australians. The relationship between ethnicity and PAD severity, distribution, and outcome were examined using non-parametric statistical tests, Kaplan-Meier and Cox proportional hazard analyses. Seventy-three Aboriginal and Torres Strait Islander and 242 non-Indigenous Australians were included and followed for a median of 6.7 [IQR 2.7, 9.3] years. Aboriginal and Torres Strait Islander patients were more likely to present with symptoms of chronic limb threatening ischaemia (81% vs. 25%; p < .001), had greater median [IQR] angiographic scores for the symptomatic limb (7 [5, 10] vs. 4 [2, 7]) and tibial arteries (5 [2, 6] vs. 2 [0, 4]) and had higher risk of major amputation (HR 6.1, 95% CI 3.6 - 10.5; p < .001) and major adverse cardiovascular events (HR 1.5, 95% CI 1.0 - 2.3; p = .036) but not for revascularisation (HR 0.8, 95% CI 0.5 - 1.3; p = .37) compared with non-Indigenous Australians. The associations with major amputation and major adverse cardiovascular events were no longer statistically significant when adjusted for limb angiographic score. Compared with non-Indigenous patients, Aboriginal and Torres Strait Islander Australians had more severe tibial artery disease and higher risk of major amputation and major adverse cardiovascular events.

Differences in Biologic Drug Effects and Distal Particulate Embolization in Three Paclitaxel-Coated Balloons for Femoropopliteal Lesions in a Rabbit Model.

A recent meta-analysis of randomized control trials demonstrated a significantly higher risk of major amputation in patients treated with drug-coated balloons (DCBs) compared with standard treatment, especially in high-dose paclitaxel-coated DCBs. Distal particulate embolization after DCB use was considered a potential cause of the higher incidence of major amputation. The current study aimed to histologically and biologically compare biologic drug effect and distal particulate embolization in 3 DCBs (a high-dose paclitaxel-coated DCB [IN.PACT Admiral] and 2 low-dose paclitaxel-coated DCBs [Ranger and Lutonix]). The DCBs were inflated in the healthy descending aortas of 18 rabbits, followed by euthanasia 28 days after the procedure. The treated descending aorta and distal skeletal muscles were histopathologically evaluated, and paclitaxel concentrations were measured. The paclitaxel concentration of the treated lesion was highest for Ranger, followed by IN.PACT and Lutonix (Ranger vs IN.PACT vs Lutonix: 1089 [745-2170] pmol/mg vs 638 [160-2075] pmol/mg vs 25 [10-304] pmol/mg, respectively; p<0.0001). In the histopathological evaluation, the angle of severe medial smooth muscle cell loss was largest for Ranger followed by IN.PACT and Lutonix (12.8 [8.0-20.4] degree vs 1.4 [1.2-5.2] degree vs 0.8 [0.5-2.5] degree, respectively), with significant differences for Ranger vs IN.PACT (p=0.007) and Ranger vs Lutonix (p=0.002). However, paclitaxel concentrations of distal skeletal muscles were lowest for Lutonix, followed by Ranger and IN.PACT (12 [1-58] pmol/mg vs 15 [13-21] pmol/mg vs 42 [19-108] pmol/mg, respectively, p<0.0001). The numbers of arteries with downstream DCB effects were highest for IN.PACT, followed by Ranger and Lutonix (Ranger vs IN.PACT vs Lutonix, 3 [3-4] vs 4 [3-7] vs 2 [1-2], respectively), which was consistent with the measured tissue paclitaxel concentrations. These findings suggest that Ranger demonstrates the strongest paclitaxel effect, as well as the second-best effect regarding distal particulate embolization, making it a good treatment option for patients with peripheral artery disease among the 3 DCBs evaluated in the current study. Further clinical head-to-head comparisons with larger numbers of patients are needed to explore which DCB is the most effective and safe treatment option.Clinical Impact:The findings of the current preclinical study suggests that Ranger demonstrates the strongest paclitaxel effect, as well as the second-best effect regarding distal particulate embolization making it a good treatment for patients with intermittent claudication and chronic limb-threatening ischemia.

Association between sex and long-term outcomes of endovascular treatment for peripheral artery disease.

Endovascular peripheral vascular intervention (PVI) has become the primary revascularization technique used for peripheral artery disease (PAD). Yet, there is limited understanding of long-term outcomes of PVI among women versus men. In this study, our objective was to investigate sex differences in the long-term outcomes of patients undergoing PVI. We performed a cohort study of patients undergoing PVI for PAD from January 1, 2010 to September 30, 2015 using data in the Vascular Quality Initiative (VQI) registry. Patients were linked to fee-for-service Medicare claims to identify late outcomes including major amputation, reintervention, major adverse limb event (major amputation or reintervention [MALE]), and mortality. Sex differences in outcomes were evaluated using cumulative incidence curves, Gray's test, and mixed effects Cox proportional hazards regression accounting for patient and lesion characteristics using inverse probability weighted estimates. In this cohort of 15,437 patients, 44% (n = 6731) were women. Women were less likely to present with claudication than men (45% vs. 49%, p < 0.001, absolute standardized difference, d = 0.08) or be able to ambulate independently (ambulatory: 70% vs. 76%, p < 0.001, d = 0.14). There were no major sex differences in lesion characteristics, except for an increased frequency of tibial artery treatment in men (23% vs. 18% in women, p < 0.001, d = 0.12). Among patients with claudication, women had a higher risk-adjusted rate of major amputation (hazard ratio [HR] = 1.72, 95% confidence interval [CI]: 1.18-2.49), but a lower risk of mortality (HR = 0.86, 95% CI: 0.75-0.99). There were no sex differences in reintervention or MALE for patients with claudication. However, among patients with chronic limb-threatening ischemia, women had a lower risk-adjusted hazard of major amputation (HR = 0.79, 95% CI: 0.67-0.93), MALE (HR = 0.86, 95% CI: 0.78-0.96), and mortality (HR = 0.86, 95% CI: 0.79-0.94). There is significant heterogeneity in PVI outcomes among men and women, especially after stratifying by symptom severity. A lower overall mortality in women with claudication was accompanied by a higher risk of major amputation. Men with chronic limb-threatening ischemia had a higher risk of major amputation, MALE, and mortality. Developing sex-specific approaches to PVI that prioritizes limb outcomes in women can improve the quality of vascular care for men and women.

Guillotine Transmetatarsal Amputations With Staged Closure Promote Early Ambulation and Limb Salvage in Patients With Advanced Chronic Limb-Threatening Ischemia

Purpose: Transmetatarsal amputation (TMA) with primary closure has long been an option for limb salvage in patients with advanced chronic limb-threatening ischemia (CLTI) with extensive tissue loss of the forefoot. However, TMA healing and closure techniques are challenging, specifically in high-risk patients. Guillotine transmetatarsal amputations (gTMA) with staged closure may provide an alternative treatment in this population. We report long-term outcomes of such technique. Materials and Methods: A single-center retrospective cohort study of CLTI patients undergoing gTMA between 2017 and 2020 was performed. Limb salvage, wound healing, and survival rates were quantified using Kaplan-Meier (KM) analysis. Multivariate regression was used to identify the effect of patient characteristics on the outcomes. Results: Forty-four gTMA procedures were reviewed. Median follow-up was 381 (interquartile range [IQR], 212–539.75) days. After gTMA, 87.8% (n=36) of the patients were able to ambulate after a median interval of 2 (IQR, 1–3) days. Eventual coverage was achieved in a personalized and staged approach by using a combination of skin substitutes (88.6%, n=39) ± split thickness skin grafts (STSG, 61.4%, n=27). KM estimates for limb salvage, wound healing, and survival were 84.1%, 54.5%, and 88.6% at 1 year and 81.8%, 63.8%, and 84.1% at 2 years. Wound healing was significantly associated with STSG application (p=0.002, OR=16.5, 95% CI 2.87–94.81). Conclusion: gTMA resulted in high limb salvage rates during long-term follow-up in CLTI patients. Adjunctive STSG placement may enhance wound healing at the gTMA site, thus leading to expedited wound closure. Surgeons may consider gTMA as an alternative to reduce limb loss in CLTI patients at high risk of major amputation. Clinical Impact Currently, the clinical presentation of CLTI is becoming more complex to deal with due to the increasing comorbidities as the society becomes older. The data shown in this article means for clinicians that when facing diffused forefoot gangrene and extensive tissue loss, limb preservation could still be considered instead of major amputation. Guillotine transmetatarsal amputations in the setting of an aggressive multidisciplinary group, can be healed by the responsibly utilization of dermal substitutes and skin grafts leading to the preservation of the extremity, allowing mobility, avoiding of sarcopenia, and decreasing frailty. This will equate to maintenance of independent living and preservation of lifespan.

The Influence of the Socioeconomic Status and the Density of the Population on the Outcome After Peripheral Artery Disease

Low socioeconomic status (SES) and living in a rural environment are associated with poorer health and a higher number of amputations among the population at large. The purpose of this study is to determine the influence of low SES and of the degree of urbanization on the short-term and long-term results of patients after revascularization for peripheral artery disease. An observational retrospective follow-up study of 770 patients operated on for peripheral artery disease at three university centers in north-western Spain from January 2015 to December 2016. The events studied were Rutherford classification of severity upon admission, direct amputation, amputations in the follow-up period, new revascularization procedures, major adverse cardiovascular events (MACE), and overall mortality. Mean personal income and income of the household associated with the street in which each patient lived and the degree of urbanization in three areas as per Eurostat criteria:densely populated areas, intermediate density areas, and thinly populated areas. Comorbidity, surgical, and follow-up variables were also collected. Descriptive analysis and Cox regression were used. Approval was obtained from the regional ethics committee. Median follow-up was 47.5months. MACE occurred in 21.5% of the series and overall mortality was 47.0%. Living in a thinly populated area is associated with a lower risk of MACE (adjusted subhazard ratio=0.60; 95% confidence interval [CI]: 0.39-0.91). Overall survival is lower in intermediate density area patients (adjusted Hazard Ratio=1.46; 95% CI: 1.07-2.00). The third quartile of mean personal and household income is associated with a higher risk of major amputation at follow-up (adjusted Odds Ratio 1.92, 95% CI: 1.05-3.52 and adjusted Odds Ratio 1.93, 95% CI: 1.0.3-3.61, respectively). Patients who live in a densely populated area run a higher risk of MACE. SESis neither associated with worse outcomes after surgery nor with MACE in long-term follow-up.

Effectiveness of cell and gene therapy in treatment of obliterating diseases of the arteries in the lower extremities: a review

The lack of significant progress in improving the results of treatment for patients with chronic lower limb ischemia (CLLI) determines a necessity to search new approaches to solve this problem. One of the promising methods for treatment of patients with CLLI is therapeutic angiogenesis. Gene and cell therapy clinical trials for this pathology have been carried out in the world for more than 20 years and showed conflicting results. It is extremely difficult to produce a drug based on cellular material, therefore the development of gene-based therapies is more promising. In most of the analyzed studies, patients with critical limb ischemia, i.e with initially with a high risk for major amputation, were included. Since the process of neoangiogenesis takes several months, it seems more logical to use that option for treatment in the earlier stages of the disease.&#x0D; VEGF-165 is the most studied angiogenic agent. Only VEGF-165 is registered as a drug for treatment of patients with CLLI. There are publications on the effectiveness of treatment with a plasmid VEGF-165-gene therapy in patients with stages II and III of CLLI according to the FontaineA.V. Pokrovsky classification in a five-year follow-up study.

Investigation of the effect of acute to chronic glycemic ratio on major amputation development after surgical thromboembolectomy in patients with acute lower extremity ischemia.

Acute limb ischemia (ALI) is an emergency vascular pathology in which perfusion is disrupted in the lower extremity and threatens extremity viability. The admission blood glucose (ABG)/estimated average glucose (eAG) value has recently been shown as a prognostic marker in acute cardiovascular events. In this study, we aimed to investigate the predictive role of an ABG/eAG value in predicting development of early postoperative major amputation after emergency thromboembolectomy operations in patients presenting with ALI. Patients who admitted to our hospital with ALI between November 01, 2016 and September 01, 2021 and underwent surgical thromboembolectomy were retrospectively included in the study. Patients who did not undergo postoperative limb amputation were recorded as Group 1, and patients who underwent major amputation in the early postoperative period (in-hospital), were recorded as Group 2. The median age of the 226 patients included in Group 1 and 72 patients in Group 2 were 58 (34-86) years and 69 (33-91) years, respectively (p<0.001). In univariate analysis, in-hospital amputation was found to significantly correlate with age>70 years (odds ratio [OR]: 1.914, 95% confidence interval [CI]: 1.351-2.319, p<0.001), PAD (OR: 1.698, 95% CI: 1.270-1.992, p = 0.002 re-embolectomy (OR: 2.184, 95% CI: 1.663-3.085, p < 0.001), admission Rutherford class (OR: 0.762, 95% CI: 0.591-0.859, p = 0.032), admission time>6 h (OR: 1.770, 95% CI: 1.480-1.152, p = 0.009), ABG (OR: 1.275, 95% CI: 1.050-1.790, p < 0.001), and ABG/eAG (OR: 1.669, 95% CI: 1.315-2.239, p < 0.001). According to our study, we can predict patient groups with a high risk of major amputation with the ABG/eAG value calculated from the blood values of the patients at the time of admission.

Long-term Outcomes of Patients Undergoing Partial Calcanectomy

Long-term Outcomes of Patients Undergoing Partial Calcanectomy

Comparison of 6-Month Outcomes of Endovascular vs Surgical Revascularization for Patients With Critical Limb Ischemia

The Bypass Versus Angioplasty for Severe Ischemia of the Leg randomized controlled trial showed comparable outcomes between endovascular revascularization (ER) and surgical revascularization (SR) for patients with critical limb ischemia (CLI). However, several observational studies showed mixed results. Most of these studies were conducted before advanced endovascular technologies were available. To compare ER and SR treatment strategies for 6-month outcomes among patients with CLI. This retrospective, population-based cohort study used the Nationwide Readmissions Database to identify 66 277 patients with CLI who underwent ER or SR from January 1, 2016, to December 31, 2018. Data analyses were conducted from January 1, 2022, to February 8, 2022. A propensity score with 1:1 matching was applied. Patients with CLI who underwent ER or SR were identified, and those with missing information on the length of stay and/or younger than 18 years were excluded. Endovascular or surgical revascularization. The primary outcome was a major amputation at 6 months. Significant secondary outcomes were in-hospital and 6-month mortality and an in-hospital safety composite of acute kidney injury, major bleeding, and vascular complication. Subgroup analysis was conducted for major amputation in high-volume centers. A total of 66 277 patients were identified between 2016 and 2018 who underwent ER or SR for CLI. The Nationwide Readmissions Database does not provide racial and ethnic categories. The mean (SD) age of the cohort was 69.3 (12) years, and 62.5% of patients were male. A total of 54 546 patients (82.3%) underwent ER and 11 731 (17.7%) underwent SR. After propensity score matching, 11 106 matched pairs were found. Endovascular revascularization was associated with an 18% higher risk of major amputation compared with SR (997 of 10 090 [9.9%] vs 869 of 10 318 [8.4%]; hazard ratio, 1.18; 95% CI, 1.08-1.29; P = .001). However, no difference was observed in major amputation risk when both procedures were performed in high-volume centers. Endovascular revascularization and SR had similar mortality rates (517 of 11 106 [4.7%] vs 490 of 11 106 [4.4%]; hazard ratio, 1.06; 95% CI, 0.93-1.20; P = .39). However, the ER group had a 17% lower risk of in-hospital safety outcomes compared with the SR group (2584 of 11 106 [23.3%] vs 2979 of 11 106 [26.8%]; odds ratio, 0.83; 95% CI, 0.78-0.88; P < .001). The results of this study suggest that ER was safer, without any difference in mortality, but ER was associated with an increased risk of major amputation compared with SR. However, the risk of major amputation was similar when both procedures were performed at high-volume centers.

ERICVA Risk Scale simplified as a predictor of amputation in critical limb ischemia.

Demonstrate that simplified ERICVA (Valladolid Critical Limb Ischaemia Risk Scale) is useful in predicting amputation in chronic limb-threatening ischemia (CLI) after one year of revascularization. A retrospective cohort study was performed. We analyzed the medical records of 93 patients over the age of 35 with the diagnosis of CLI who were treated in the Department of Internal Medicine, Orthopedics or in the Cardiovascular Surgery Unit of the Víctor Lazarte Echegaray Hospital and the High Complexity Virgen de La Puerta Hospital during the period 2015-2018. The simplified ERICVA score was determined in patients before surgical and endovascular revascularization. We included 31 patients who scored 2 or more points in the exposed group and 62 patients who scored less than 2 points in the group not exposed to amputation risk. The collected data was analyzed with the statistical program SPSS where the Relative Risk and significance was obtained with Pearson's Chi-square. The multivariate analysis was also carried out in order to obtain the adjusted relative risk. It was identified that the simplified ERICVA score greater than or equal to 2 points was more frequent in those who underwent amputation (90.3%) compared to patients who did not undergo amputation (4.8%), increasing the risk of amputation in those patients with CLI who underwent revascularization (RR: 18.67, P<0.001). It was also possible to identify that within the group of patients that showed a high risk of amputation according to the ERICVA scale, they had a higher risk of major amputation (RR: 9.32, P<0.001) as opposed to the risk of minor amputation (RR: 1, 89, P=0.193). Among the items of the simplified ERICVA scale, the preoperative neutrophil-lymphocyte ratio and hematocrit were significantly higher in the group of amputated patients (P<0.001). In addition, it was possible to identify that the score greater than or equal to 2 was independently associated with the risk of amputation in patients revascularized with CLI (RR: 13.5, P<0.001). In our patient population, the simplified ERICVA scale is useful in predicting major and minor amputation in critical limb ischemia after revascularization. The present data showed that the patients who had a simplified ERICVA score greater than or equal to 2 had a higher risk of major amputation compared to the risk of minor amputation. However, it is important to highlight that the impact on the prediction of minor amputation is greater because in some circumstances major amputation can appear as a complication of CLI.

Evaluation of Infrapopliteal Revascularization for Ischemic Diabetic Foot in Hemodialysis Patients

Objective: To evaluate the outcomes of infrapopliteal revascularization for diabetic hemodialysis patients with ischemic diabetic foot. Methods: From 2017 to 2021, 250 patients with diabetic foot identified as stage C (ischemia) or D (ischemia and infection) of Texas Wound Classification underwent successful infrapopliteal surgical and endovascular revascularization at the vascular surgery department of Moulay Ismail Military Hospital in Meknes. The outcomes were retrospectively compared in hemodialyzed patients (HD group: 48 patients), and not hemodialyzed patients (not HD group: 202 patients) during the same period. Results: Outcomes were expressed as healing, major amputation, revascularization patency and mortality rate. Hemodialysis was a negative predictor of healing and a positive predictor of major amputation. Outcomes for HD and not HD groups were respectively: healing (62.5 vs 82 %), major amputation (37.5 vs 18 %). There was no significant difference in revascularization primary patency between the two groups (70 vs 73.6%). The mortality rate was higher in the HD group than in the not HD group (21 vs 10%). Conclusions: Our study shows that ischemic diabetic foot associated with hemodialysis have a bad prognosis with a higher risk of major amputation and death. Infrapopliteal revascularization with infection control should be performed to enhance the rate of limb salvage in this risk group.

Association Of Loss Of Commercial Insurance And The Risk Of Lower Extremity Amputation In Peripheral Artery Disease

INTRODUCTION METHOD The PearlDiver insurance claims dataset (2010 to 2019) was queried for adult patients (>18 years) with commercial insurance and at least three years continuous enrollment after PAD diagnosis. Patients were categorized into continuous cohort (continue commercial insurance coverage) and loss of insurance cohort (transition to Medicaid or no insurance). Logistic regression was performed for the crude cohort and propensity matched cohort (using age, gender, and Charleston Comorbidity Index) to evaluate association between loss of insurance and risk of major and minor amputation. RESULTS We identified N=92,772 patients with continuous commercial insurance during the three-year query period and N=213,097 patients who had interrupted coverage. In the crude cohort, loss of insurance was associated with 77% higher risk of major amputation (95% confidence interval (CI) 1.49-2.12) and 42% higher risk of minor amputation (95% CI 1.31-1.53). Matched cohort showed similar results in a subset of N=91,480 patients, with 233% higher risk of major amputation (95% CI 1.96-2.80) and 203% higher risk of minor amputation (95% CI 1.88-2.21) in the loss of insurance group. CONCLUSIONS Loss of commercial insurance is associated with increased risk of major and minor amputations in PAD patients. This may be related to delayed presentation to primary or specialty care, variations in physician willingness to treat uninsured patients, and differences in available treatment options. The PearlDiver insurance claims dataset (2010 to 2019) was queried for adult patients (>18 years) with commercial insurance and at least three years continuous enrollment after PAD diagnosis. Patients were categorized into continuous cohort (continue commercial insurance coverage) and loss of insurance cohort (transition to Medicaid or no insurance). Logistic regression was performed for the crude cohort and propensity matched cohort (using age, gender, and Charleston Comorbidity Index) to evaluate association between loss of insurance and risk of major and minor amputation. We identified N=92,772 patients with continuous commercial insurance during the three-year query period and N=213,097 patients who had interrupted coverage. In the crude cohort, loss of insurance was associated with 77% higher risk of major amputation (95% confidence interval (CI) 1.49-2.12) and 42% higher risk of minor amputation (95% CI 1.31-1.53). Matched cohort showed similar results in a subset of N=91,480 patients, with 233% higher risk of major amputation (95% CI 1.96-2.80) and 203% higher risk of minor amputation (95% CI 1.88-2.21) in the loss of insurance group. Loss of commercial insurance is associated with increased risk of major and minor amputations in PAD patients. This may be related to delayed presentation to primary or specialty care, variations in physician willingness to treat uninsured patients, and differences in available treatment options.

Prognostic Risk Factors for the Development of Compartment Syndrome in Acute Lower Limb Ischemia Patients Treated With Catheter-Directed Thrombolysis

To determine predisposing factors that may lead to the development of compartment syndrome (CS) in patients with acute lower limb ischemia (ALLI) managed with intra-arterial catheter-directed thrombolysis (CDT). This is a retrospective study of patients admitted between 01/2002 and 12/2015 to three university hospitals in Tampere, Turku, and Oulu, Finland, with acute or acute-on-chronic lower limb ischemia (Rutherford I-IIb). Patients managed with CDT and aspiration thrombectomies (AT) as an adjunct to CDT were included in the study. Multivariable binary logistic regression models were used to detect possible risk factors for the development of CS and its impact on the limb salvage and survival. Amputation-free survival (AFS) rates of CS and non-CS patients were compared using Kaplan-Meier survival analysis. The length of hospitalization was calculated and compared between the CS and non-CS groups. A total of 292 CDTs with or without ATs were performed on patients with a mean age of 71 years (standard deviation 13 years), 151 (51.7%) being male. Altogether, 12/292 (4.1%) treatment-related CS cases were registered. Renal insufficiency (odds ratio [OR] 4.27, P=0.07) was associated with an increased risk of CS. All CS cases were managed with fasciotomies. Treatment with fasciotomy was associated with a prolonged hospitalization of a median of 7 days versus the 4 days for non-CS patients, P < 0.001. During the median follow-up of 51 months (interquartile range 72 months), 152/292 (52.1%) patients died and 51/292 (17.5%) underwent major amputations. CS was not associated with an increased risk of mortality, but it was associated with a higher risk of major amputation (OR 3.87, P=0.027). The AFS rates of patients with or without CS did not significantly differ from each other in the long term. CS after CDT for the treatment of ALLI is uncommon. Renal insufficiency is associated with an increased risk of CS. Fasciotomy prolongs the hospitalization. Patients with CS are exposed to an increased risk of major amputation.

Statins Save Limbs in Patients With Chronic Limb Threatening Ischemia and End-Stage Renal Disease

Statins improve survival in patients with chronic limb threatening ischemia (CLTI) but have failed to demonstrate benefit for limb salvage (LS). We sought to identify whether statins could improve LS among subgroups of CTLI patients with a higher risk of major amputation.

265-OR: Black Race, Rurality, and Neighborhood Disadvantage in Major Amputations: A Medicare Cohort Study

Background: Black, rural, and disadvantaged neighborhood populations are at increased risk of major amputations due to diabetic foot ulcers (DFU). We aimed to determine how the intersection of these health disparity factors is tied to outcomes.Methods: We built a retrospective cohort of 124,487 patients hospitalized with DFU in 2014 with the 100% national Original Medicare population. We used logistic regression and marginal modeling to estimate 30-day composite major amputation/death rates, controlling for other sociodemographics and comorbidities, with interaction terms between the three disparity factors of focus.Results: The predicted rate of major amputation or death for black patients was 19.6% (95% CI 19.0-20.2), compared to 17.3% (17.1-17.6) for white patients, and 17.6% overall. Those living in a disadvantaged neighborhood had a predicated rate of 18.6% (18.1-19.1), compared to 17.4% (17.1-17.6) for those living in a non-disadvantaged neighborhood. Small town residence predicted a 20.2% (19.2-21.1) rate, compared to 16.9% (16.7-17.2) for urban residence. The predicted rate for black patients living in disadvantaged, small towns was 24.2% (20.6-27.8, Figure), with a significant interaction between black race and small town (OR 1.59, p<0.001).Conclusion: Black patients in small towns face high risk of major amputation or death. Such disparities call for new intervention strategies.View largeDownload slideView largeDownload slide DisclosureM. Brennan: None. J. Kramer: None. W. Powell: None. A. J. H. Kind: None. C. M. Bartels: Research Support; Self; Pfizer Foundation.FundingAgency for Healthcare Research and Quality (K08HS02679); National Institute of Diabetes and Digestive and Kidney Diseases; National Institute on Aging (RF1AG057784); National Institute on Minority Health and Health Disparities (R01MD010243)

A Review and Proposed Classification System for the No-Option Patient With Chronic Limb-Threatening Ischemia

A growing, but poorly defined subset of patients with chronic limb-threatening ischemia (CLTI) have “no option” for revascularization. One notable subgroup includes patients with severe ischemia and advanced pedal artery occlusive disease, termed “desert foot,” who are at high risk for major amputation due to a lack of conventional revascularization options. Although new therapies are being developed for no-option patients with desert foot anatomy, this subgroup and the broader group of no-option patients are not well defined, limiting the ability to evaluate outcomes. Based on a systematic review, a classification of the no-option CLTI patient was constructed for use in clinical practice and studies. Several no-option conditions were identified, including type I—severe and pedal occlusive disease (desert foot anatomy) for which there is no accepted method of repair; type II—lack of suitable venous conduit for bypass in the setting of an acceptable target for bypass; type III—extensive tissue loss with exposure of vital structures that renders salvage impossible; type IV—advanced medical comorbidities for which available revascularization options would pose a prohibitive risk; and type V—presence of a nonfunctional limb. While type I and type II patients may have no option for revascularization, type III and type V patients have wounds, infection, comorbidities, or functional status that may leave them with few options for revascularization. As treatment strategies continue to evolve and novel methods of revascularization are developed, the ability to identify no-option patients in a standardized fashion will aid in treatment selection and assessment of outcomes.