Clinical outcomes of total femoral replacement. First Latin American experience.

INTRODUCTION: The femur is frequently affected by primary and metastatic bone tumors. In cases with substantial bone loss, Total Femur Replacement (TFR) remains the only viable limb preservation option. This study investigates the clinical outcomes of TFR patients in a Latin American setting, with a minimum 3-year follow-up. METHODS: Retrospective review identifying cases of TFR at a single center from 2009 to 2020. Patients who had TFR either due to oncological indications or complications arising from oncology-related surgeries were included. Data on the indications for surgery and post-operative complications were recorded. To assess functional status, the Musculoskeletal Tumor Society (MSTS) score and the Toronto Extremity Salvage Score (TESS) were used. RESULTS: Fourteen patients met the inclusion criteria. Diagnoses included eight osteosarcomas, four chondrosarcomas, one Ewing sarcoma, and one giant cell tumor. Ten patients had undergone prior surgeries. Indication for TFR was a complication of a previous surgery in 78.6 % of cases. Post-TFR complications were experienced by 35.7 % of patients, requiring further surgeries. At the 3-year mark, average MSTS and TESS scores were 67.4 % and 70.8 %, respectively. CONCLUSION: Total femur replacement serves as a valuable limb salvage solution for patients with significant femoral defects in oncological scenarios, however, there is a significant risk of complications. Given its potential benefits, it is essential for developing countries to consider incorporating TFR into their healthcare systems.

Insulin Requirement and Infrainguinal Bypass Outcomes in Patients with Peripheral Arterial Disease.

BACKGROUND: Diabetes mellitus (DM) is a major risk factor for peripheral artery disease. The association of DM with major adverse limb events (MALE) after lower extremity revascularization remains controversial, as patients with diabetes are typically analyzed as a single, homogenous group. Using a large national database, this study examines the impact of insulin use and glycemic control on the outcomes following infrainguinal bypass. The hypothesis is that prevalent insulin therapy and elevated hemoglobin A1c (HbA1c) are associated with an increased risk of MALEs after infrainguinal bypass in patients with DM and could therefore be used for risk stratification. METHODS: The Vascular Quality Initiative database files for infrainguinal bypass (2007-2021) were retrospectively reviewed. Patients with DM undergoing bypass for peripheral artery disease were included. Patients on dialysis or with prior kidney transplantation were excluded. The characteristics and outcomes of patients with insulin-requiring diabetes mellitus (IRDM) were compared to those of patients not requiring insulin (noninsulin-requiring diabetes mellitus [NIRDM]) prior to the bypass procedure. RESULTS: A total of 9,686 patients with DM (56% IRDM) underwent bypass. Patients with IRDM were significantly younger than patients with NIRDM, more likely to be female (P < 0.01), African American (P < 0.01), and Hispanic (P = 0.031), and more likely to have comorbidities and be categorized into American Society of Anesthesiologist classes IV-V. They were more likely to be treated for chronic limb-threatening ischemia (P < 0.001). Patients with IRDM had significantly higher perioperative complications with no difference in perioperative mortality between the 2 groups. Beyond the perioperative period, with a mean follow-up of 427 days, patients with IRDM had significantly lower crude rates of primary patency and higher crude rates of major amputation, MALE, and mortality compared to patients with NIRDM. Regression analyses demonstrated that insulin requirement, but not HbA1c, was independently associated with a higher risk of MALE (hazard ratio = 1.17 [1.06-1.29]) and mortality (hazard ratio = 1.28 [1.16-1.43]). CONCLUSIONS: Insulin requirement, but not HbA1c, is significantly associated with MALEs and survival after infrainguinal bypass in the Vascular Quality Initiative. Stratification of patients with DM based on their prevalent insulin use prior to infrainguinal bypass surgery could improve the prediction of outcomes of peripheral arterial bypass surgery in patients with diabetes.

Wound, Ischemia, Foot Infection (Wifi) Classification System And Its Predictive Ability Concerning Amputation-Free Survival, Mortality And Major Limb Amputation In A Portuguese Population: A Single Center Experience.

INTRODUCTION: Commonly used chronic limb-threatening ischemia (CLTI) classifications lack granularity and detail to precisely stratify patients according to risk of limb loss, expected revascularization benefit and mortality. The aim of this study is to evaluate in a Portuguese population the prognostic value of an updated CLTI classification based on Wound, Ischemia, and foot Infection (WIfI) proposed by the Society for Vascular Surgery. MATERIALS AND METHODS: Single-center retrospective evaluation of prospectively collected data of consecutive patients with CLTI submitted to lower limb revascularization from January to December of 2017. All consecutive patients with chronic peripheral artery disease with ischemic rest pain or tissue loss were included. The exclusion criteria were patients with intermittent claudication, vascular trauma, acute ischemia, non-atherosclerotic arterial disease and isolated iliac intervention. The primary end-point was major limb amputation, mortality and amputation-free survival (AFS) at 30 days, 1 year and 2 year follow-up. Secondary end-points were minor amputation, wound healing time (WHT) and rate (WHR). RESULTS: A total of 111 patients with CLTI were submitted to infra-inguinal revascularization: 91 endovascular and 20 open surgery. After categorizing them according to the WIfI: 20 had stage 1 (18.52%), 29 stage 2 (26.85%), 38 stage 3 (35.19%) and 21 stage 4 (19.44%). Overall mortality rate was 1.8%, 17% and 22.3% at 30 days, 1 year and 2 years follow-up. Major amputation rate was 0.9%, 2.7% and 2.7% at 30 days, 1 year and 2 years follow-up. AFS rate was 97.3%, 82.1%, and 76.8% at 30 days, 1 year, 2 years follow-up. In multi-variable analysis, higher WIfI score was the only predictive factor for mortality and AFS. WIfI 3 and 4 were also associated with increased risk of non-healing ulcer. CONCLUSION: This study proved the prognostic value of the WIfI classification in a Portuguese population by showing an association between higher scores and increased mortality, lower AFS and non-healing ulcer.

Cross-Limb Vascular Shunting for Traumatic Popliteal Artery Injury.

BACKGROUND: Popliteal artery injury (PAI) is a challenging trauma that requires prompt and accurate treatment since the probability of lower-limb amputation increases with the ischemic time. Intravascular shunting and cross-limb vascular shunting (CLS) are used as temporary vascular shunting (TVS) methods to shorten the ischemic time for limb vascular injury. CLS involves sending blood from an artery in a healthy body part to a peripheral vessel in an injured part to immediately resume blood flow to the injured limb. For closed injuries including PAI, CLS may be performed without exploring and identifying the arterial stumps and it enables early reperfusion to the ischemic limb. We report the case series of traumatic PAI treated using CLS and verify the usefulness of CLS. METHODS: All patients with traumatic PAI treated with CLS at our institution between August 2013 and December 2021 were included. Demographic and clinical patient characteristics were extracted from the medical records. Comorbid injuries, severity of acute limb ischemia based on the Rutherford grading scale, time from injury to reperfusion by CLS, time from injury to completion of artery, and the use of fasciotomy were investigated. As outcomes, we investigated the presence or absence of lower extremity amputation during the course of treatment. RESULTS: We used CLS as treatment for 5 cases with traumatic PAI. Based on the Rutherford grading scale for acute limb ischemia, there were one limb with grade 2B and 4 with grade 3. Amputation of the lower extremities was avoided except for 1 extremity in which arterial reconstruction was not achieved due to unexplained cardiac arrest during surgery. CONCLUSIONS: CLS enables early reperfusion of the injured limb and is effective as a TVS method for traumatic PAI with severe ischemia or soft tissue damage.

Inflammation Is a Histological Characteristic of Skeletal Muscle in Chronic Limb Threatening Ischemia.

BACKGROUND: The loss of skeletal muscle is a prognostic factor in several diseases including in patients with chronic limb threatening ischemia (CLTI). Patients with CLTI also have a lower skeletal mass and area when compared to those with claudication. However, there are no currently available data regarding the histological characteristics of core muscles in patients with CLTI. This study aims to determine the differences in core skeletal muscles between patients with claudication and those with CLTI. The second aim is to evaluate the differences in myokines, which are molecules secreted by skeletal muscle, between patients with claudication and those with CLTI. METHODS: An observational, prospective study was conducted from January 2018 to July 2022 involving consecutive patients with peripheral arterial disease (PAD). The clinical characteristics were registered. In PAD patients with surgical indication for common femoral artery approach, samples of sartorius skeletal muscle (and not from the limb muscles directly involved in the ischemic process) were collected. The samples were submitted to histological characterization on hematoxylin-eosin and to immunohistochemical analysis to detect CD45+ leukocytes and CD163+ macrophages. The extent of the inflammatory cells (leukocytes and macrophages) was semiquantitatively assessed using a 0-to-4 grade scale as follows: absent (0†), mild (†), moderate (††), severe (†††), and very severe (††††). Serum levels of myokines: irisin, myostatin, IL-8, and lL-6 were determined with multiplex bead-based immunoassay. RESULTS: 119 patients (mean age: 67.58 ± 9.60 years old, 79.80% males) 64 with claudication and 54 with CLTI were enrolled in the study. No differences were registered between patients with claudication and those with CLTI on age, gender, cardiovascular risk factors, and medication, except on smoking habits. There was a significantly higher prevalence of smokers and a higher smoking load in the claudication group. Samples of sartorius skeletal muscle from 40 patients (14 with claudication and 26 with CLTI) were submitted to histological analysis. No differences were found in skeletal muscle fibers preservation, trauma, or hemorrhage (on hematoxylin-eosin staining). However, in the immunohistochemistry study, we found more inflammatory cells CD45+ leukocytes in patients with CLTI when compared to those with claudication [CD45+ ≥ moderate (††): claudication (n = 14): 4; 28.57%; CLTI (n = 25): 16; 64.00%; P = 0.034]. Patients with CLTI also had higher tissue levels of CD163+ macrophages, but this difference was not significant [CD163+ ≥ moderate (††): claudication (n = 13): 7; 53.85%; CLTI (n = 27): 21; 77.78%; P = 0.122]. The serum levels of the myokines, irisin, and myostatin were below the lower limit of detection, in the majority of patients, so no valid results were obtained. However, patients with CLTI had a higher serum level of Interleukin (IL)-6 and IL-8. CONCLUSIONS: CLTI patients exhibit increased quantities of leukocytes in their sartorius muscle, as well as elevated serum levels of myokines IL-8 and IL-6. Inflamed skeletal muscle can contribute to the loss of muscle mass and account for the lower density of skeletal muscle observed in CLTI. Additionally, inflamed skeletal muscle may contribute to the development of systemic inflammation through the secretion of pro-inflammatory cytokines into the systemic circulation. Halting the inflammatory process could eventually improve the prognosis of CLTI patients.

Impact of wound management strategies after revascularization for chronic limb-threatening ischemia.

OBJECTIVE: There is no established consensus or guidelines for wound management after revascularization for patients with chronic limb-threatening ischemia (CLTI) without severe infection. This study is designed to evaluate the clinical effect of the wound management strategy on toe wounds after revascularization for CLTI. METHODS: This retrospective cohort study was performed at eight institutions affiliated with Keio University School of Medicine in Japan and included 261 patients who underwent revascularization for CLTI between April 2019 and July 2021. We identified 132 patients with toe wounds from the database who had restored in-line blood flow to the foot. Patients were divided into two groups by the timing of toe resection after revascularization, which dictated the wound management policy. Group A (62 patients) underwent early toe amputation for suspected osteomyelitis, whereas group B (70 patients) underwent watchful waiting. The primary outcome was wound healing after revascularization; the secondary outcome was major amputation. We compared outcomes between groups A and B after propensity score matching. RESULTS: Using propensity score matching, each patient in group A (33 patients) was matched with a patient in group B (33 patients). Wound healing in matched group A was significantly better than that in matched group B (respectively: 1-year wound healing rate: 90.0% vs 68.2%, P < .001; median wound healing time: 65 days vs 258 days, P < .01). Although five major amputations were necessary in matched group B, none were required in matched group A (P = .05). The high rate of major amputations in group B was attributed to the sudden exacerbation of infection. Limb salvage rate in matched group A exceeded matched group B (100.0% vs 90.5%: 1-year limb salvage rate, P = .02). CONCLUSIONS: Early toe amputation for highly suspected osteomyelitis in patients with CLTI with toe wounds may expedite wound healing compared with watchful waiting, potentially avoiding unnecessary major amputation. Considering the wound management strategy is crucial when evaluating wound healing outcomes in patients with CLTI with revascularization.

Risk Analysis and Clinical Outcomes in Chronic Limb-threatening Ischemia Patients with Surgical Site Infection after Distal Bypass.

BACKGROUND: A recent randomized control study showed that long-term outcomes after surgical revascularization were superior to those after endovascular treatment for cases with chronic limb-threatening ischemia (CLTI) with an appropriate single-segment great saphenous vein. However, surgical site infection (SSI) in CLTI cases after infrapoplital bypass also resulted in a prolonged hospital stay and poor outcomes, including graft disruption. The aim of the current study was to analyze risk factors for SSI in CLTI patients after distal bypass and to compare outcomes in patients with and without SSI. METHODS: A total of 515 cases that underwent distal bypass at a single center between 2009 and 2022 were analyzed retrospectively. Comparisons were made between patients with and without SSI after distal bypass. The primary end point was limb salvage after distal bypass. RESULTS: Of the 515 cases that underwent distal bypass, 79 (15%) had SSI. The risk factors for SSI were preoperative antibacterial drug use (P = 0.001), pedal bypass (P = 0.001), and prolonged operation time (≥150 min) (P = 0.010). The median hospital stay in SSI cases was longer than that in non-SSI cases (P < 0.001). Of 515 distal bypasses, 7 (1.3%) bypass grafts ruptured postoperatively due to SSI, and of these 7 cases, 6 ruptured during the day, 5 cases occurred within 1 month postoperatively, and 2 patients (29%) are alive without amputation. The mean follow-up period was 34 ± 30 months. During follow-up, 62 limbs (SSI cases, 19; non-SSI cases, 43) required major amputation and there were 234 deaths (SSI cases, 46; non-SSI cases, 188). The 1-, 3-, and 5-year limb salvage rates of 82%, 71%, and 62%, respectively, in SSI cases were significantly lower than those in non-SSI cases (P < 0.001). The 5-year survival rate of 29% in SSI cases showed a tendency to be lower than that in non-SSI cases (P = 0.058). CONCLUSIONS: The limb salvage rate in SSI cases was lower than in non-SSI cases after distal bypass. Graft rupture due to SSI occurred at a rate of 1.3% and resulted in poor outcomes in most cases. SSIs adversely affect outcomes and further study is needed to identify methods to avoid SSI following distal bypass.

Comparison of limb outcomes between bypass surgery and endovascular therapy in dialysis-dependent and -independent patients with chronic limb-threatening ischemia.

OBJECTIVE: To examine limb salvage (LS) and wound healing in dialysis-dependent and -independent patients with chronic limb-threatening ischemia (CLTI) after infrainguinal bypass surgery or endovascular therapy (EVT). METHODS: We retrospectively analyzed the multi-center data of patients who underwent infrainguinal revascularization for CLTI with Wound, Ischemia, and foot Infection (WIfI) stage 2 to 4 between 2015 and 2020. The primary endpoint was LS. The secondary endpoint included wound healing, amputation-free survival (AFS), periprocedural complications, and 2-year survival. Comparison of these outcomes were made after propensity score matching. RESULTS: We analyzed 252 dialysis-dependent (318 limbs) and 305 dialysis-independent (354 limbs) patients. Propensity score matching extracted 202 pairs with no significant differences in characteristics. The LS rate in bypass surgery was better than that in EVT in dialysis-dependent patients (P < .001). There was no significant difference in the LS rates between bypass surgery and EVT in dialysis-independent patients (P = .168). The wound healing rate of bypass surgery was better than that of EVT both dialysis-dependent and -independent patients with CLTI. The AFS rate of bypass surgery was better than that of EVT in dialysis-dependent patients (P < .001). There was no significant difference in the AFS rates between bypass surgery and EVT in dialysis-independent patients (P = .099). There was no significant difference in the occurrence of Clavien-Dindo ≥ IV and V between bypass surgery and EVT in dialysis-dependent and -independent patients. Age ≥75 years, serum albumin levels <3.5 g/dL, and non-ambulatory status were risk factors for 2-year mortality in dialysis-dependent patients. The 2-year survival rates in dialysis-dependent patients with risk factors of 0, 1, 2, and 3 were 82.5%, 67.1%, 49.5%, and 10.2%, respectively (P < .001). CONCLUSIONS: For LS and wound healing, bypass surgery was preferred for revascularization in dialysis-dependent patients with WIfI stage 2 to 4. Although dialysis dependency was one of the risk factors for 2-year mortality, dialysis-dependent patients, who have 0 to 1 risk factors, may benefit from bypass surgery, as 2-year survival of >50% is expected.

Association Between the Society for Vascular Surgery (SVS)-WIfI (Wound, Ischemia, Foot Infection) Classification, Wagner-Meggitt Classification, and Amputation Rate in Patients With Diabetic Foot Infection.

Diabetic foot infection (DFI) is a common problem in patients with diabetic foot disease. Amputations and other complications of DFI lead to significant morbidity and mortality. The Society for Vascular Surgery (SVS)-WIfI (wound, ischemia, and foot infection) classification system can evaluate the benefit from revascularization and the risk of amputation in 1 and 3 years. We aimed to evaluate SVS-WIfI and Wagner-Meggitt (WM) prediction of DFI outcome, and to determine factors associated with major amputation and mortality rate. The patients with diabetes who presented between June 2018 and May 2020 with characteristics suggesting a more serious DFI or potential indications for hospitalization were reviewed in this cohort study. Demographic data, clinical characteristics, and type of revascularization were evaluated. One-year and 3-year amputation and mortality rates were the main outcomes. The grading of WM classification and the SVS-WIfI score were compared between amputation and nonamputation groups. Association between mortality and comorbidity were analyzed. One hundred and thirty-one patients admitted with DFI were included in study. And 73.28% had peripheral arterial disease (PAD). The 1-year and 3-year major amputation rates were 16.03% and 26.23%, respectively. Seventy-eight (59.54%) patients required minor amputation to control infection before revascularization. PAD (risk ratio [RR] 1.47: 95% confidence interval [CI] 1.29-1.67, P = .032), benefit from revascularization clinical stage 3 on SVS-WIfI score (RR 4.56: 95%CI 1.21-17.21, P = 0.007), and high WM classification score (RR 9.46: 95% CI 5.65-15.82, P < 0.001) were associated by multivariate analysis with high amputation rates. 1-year & 3-year amputation risk on SVS-WIfI score were not associated with amputation rates in DFI (P = .263 and .496). Only 9 (6.8%) patients were lost to follow up during the 3-year period. WM classification score, SVS-WIfI score on benefit from revascularization, and PAD were strongly associated with major amputation rates in patients with DFI.

Soft Tissue Reconstruction After Revascularization.

Diabetic foot ulcer represents the primary cause of hospital admissions, amputations, and mortality in diabetic patients. The development of diabetic foot ulcers is influenced by peripheral neuropathy, infection, and ischemia, with diabetes contributing to peripheral artery disease. Free tissue transfer combined with revascularisation of the lower extremity provides the potential opportunity for limb salvage in individuals with lower extremity defects due to critical limb ischemia and diabetic foot.

Management of Acute Lower Limb Ischemia Without Surgical Revascularization - A Population-Based Study.

OBJECTIVES: To evaluate outcomes of management without surgical revascularization in patients with acute lower limb ischemia (ALI) in a population-based setting. DESIGN: Retrospective observational population-based study. MATERIALS: Patients from Malmö, Sweden, hospitalized for ALI between 2015 and 2018. METHODS: In-hospital, surgical, radiological, and autopsy registries were scrutinized for descriptive data on ALI patients managed by endovascular and open vascular surgery, conservative vascular therapy, primary major amputation, and palliative care. RESULTS: Among 161 patients, 73 (45.3%) did not undergo any operative revascularization. Conservative vascular therapy, primary amputation, and palliative care were conducted in 25 (15.5%), 26 (16.1%), and 22 (13.7%) patients, respectively. Conservatively treated patients had Rutherford class ≥ IIb ischemia and embolic occlusion in 33% and 68% of cases, respectively. Their median C-reactive protein level at admission was 7 mg/L (interquartile range 2 - 31 mg/L). Among conservatively treated patients, anticoagulation therapy in half to full dose was given to 22 (88%) patients for six weeks or longer, and analgesics in low or moderate doses were given to twelve (48%) patients at discharge. The major amputation rate at 1 year was 8% among conservatively treated patients, and four patients with foot embolization had not undergone amputation at 1 year. CONCLUSION: Patients selected for initial conservative therapy of ALI with anticoagulation alone may have a good outcome, even when admitted with Rutherford class IIb ischemia. A low C-reactive protein level at admission seems to be a favorable marker when choosing conservative therapy. A prospective, preferably multicenter, study with a predefined protocol in these conservatively treated patients is warranted to better define the dose and length of anticoagulation therapy.

High Mortality in Patients With an Ischemic Foot Ulcer Following Revascularization.

Critical limb ischemia (CLI) is the advanced stage of peripheral arterial disease, which impairs blood flow to the extremities due to occlusion of arteries, in which patients suffer from ischemic pain at rest and gangrene or ulcers. It is frequently accompanied by major adverse cardiac events, resulting in exceedingly high mortality from a cardiac or cerebrovascular event in this population. Although there have been considerable amounts of novel and costly revascularization and wound dressing technology, mortality is still high. Therefore, the risk factors for such high mortality need to be addressed. This review aimed to summarize the potential risk factors for mortality in patients with CLI of the lower extremities. There are several such risk factors, including modifiable and nonmodifiable risk factors. This review further discusses some highlighted major modified risk factors, including renal failure, cardiovascular, and diabetes. The strategy of regular surveillance and modification of such risk factors in any patients with CLI should be developed.

Long-term outcome and cancer incidence after lower extremity bypass surgery in patients with critical limb threatening ischemia.

PURPOSE: The influence of cancer development on long-term outcome after lower extremity bypass surgery in patients with critical limb threatening ischemia was investigated. METHODS: Patient survival and cancer incidence were recorded for 21,082 patients with peripheral artery disease (PAD) stage III (n = 5631; 26.7%) and stage IV (n = 15,451; 73.3%) registered with the AOK health insurance company in Germany who underwent infrainguinal bypass surgery. All patients were preoperative and in their history cancer-free. RESULTS: After a median follow-up of 44 months, 25.6% of all patients developed cancer (Kaplan-Meier estimated), with no significant differences between patients with PAD stage III and IV (cancer incidence stage III 25.7%, stage IV 25.5%; p = 0.421). In the Cox regression analysis, male gender (HR 1.885; 95% CI 1.714-2.073, p < 0.001) and age over 70 years (HR 1.399; 95% CI 1.285-1.522, p < 0.001) were significant risk factors for the development of cancer. Survival was significantly lower in stage IV (23.4%) compared to stage III (44.5%) (HR 1.720; 95% CI 1.645-1.799, p < 0.001). Cancer was a significant risk factor for overall survival in PAD stage III patients (HR: 1.326; 95% CI 1.195-1.471, p < 0.001) but not in PAD stage IV (HR 0.976; 95% CI 0.919-1.037, p = 0.434). CONCLUSION: Patients with PAD stage III have significantly better survival after infrainguinal bypass surgery compared to patients with stage IV. While cancer incidence was essential for survival in stage III, it was of no importance in stage IV.

Limb salvage and survival after urgent surgical treatment of popliteal artery aneurysm.

BACKGROUND: Popliteal artery aneurysms (PAAs) need urgent treatment in case of acute thrombosis, distal embolization, or rupture. Few data are available in the literature about the treatment results in these scenarios. The aim of the present study was to evaluate an 11-year multicenter experience in the urgent treatment of PAAs. METHODS: All symptomatic PAAs surgically treated in two vascular centers between 2010 and 2021 were retrospectively analyzed. In the postoperative period periodical clinical and Duplex-Ultrasound evaluation were performed. The evaluated endpoint was the outcome of urgent PAAs treatment according to their clinical presentation. Statistical analysis was performed by Kaplan-Meier log-rank evaluation and multivariable Cox regression tests. RESULTS: Sixty-six PAAs needed an urgent repair. Twelve (18%) patients had a PAA rupture and 54 (82%) had an acute limb ischemia (ALI) due to either distal embolization or acute thrombosis. Patients with ALI underwent bypass surgery in 51 (95%) cases, which was associated with preoperative thrombolysis in 18 (31%) cases. A primary major amputation was performed in 3 (5%) cases. The mean follow-up was 52 ± 21 months with an overall 5-year limb salvage of 83 ± 6%. Limb salvage was influenced only by the number of patent tibial arteries (pTA) [5-years limb salvage 0%, 86 ± 10%, 92 ± 8% and 100% in case of 0, 1, 2 or 3 pTA, respectively (P = .001)]. An independent association of number of pTA and limb loss was found [hazard ratio (HR): 0.14 (95% confidence interval (CI) 0.03-0.6), P = .001]. Overall 5-year survival was 71 ± 7%. Ruptured PAAs were associated with lower 5-year survival compared with the ALI group (48 ± 2% vs. 79 ± 7%, P = .001). The number of pTA (33 ± 20%, 65 ± 10%, 84 ± 10% and 80 ± 10% for 0, 1, 2 and 3 pTA, respectively, P = .001) and the thrombolysis (94 ± 6% vs. 62 ± 10%, P = .03) were associated with higher survival in patients with ALI. There was an independent association of number of pTA and long-term survival [HR 0.15 (95% CI 0.03-0.8), P = .03]. CONCLUSIONS: PAA rupture is the cause of urgent PAA treatment in almost one fifth of cases, and it is associated with lower long-term survival. ALI can benefit from thrombolysis, and long-term limb salvage and survival are associated with the number of pTA.

Medial arterial calcification score is associated with increased risk of major limb amputation.

OBJECTIVE: The pedal medial arterial calcification (MAC) score has been associated with risk of major limb amputation in patients with chronic limb-threatening ischemia. This study aimed to validate the pedal MAC scoring system in a multi-institutional analysis to validate its usefulness in limb amputation risk prediction. METHODS: A multi-institution, retrospective study of patients who underwent endovascular or open surgical infrainguinal revascularization for chronic limb-threatening ischemia was performed. MAC scores of 0 to 5 were assigned based on visible calcified arteries on foot X ray then trichotomized (0-1, 2-4, 5) for analysis. The primary outcome was major limb amputation at 6 months. Adjusted Kaplan-Meier models were used to analyze time-to-major amputation across groups. RESULTS: There were 176 patients with 184 affected limbs (mean age, 66 years; 61% male; 60% White), of whom 97% presented with a wound. The MAC score was 0 in 41%, 1 in 9%, 2 in 13%, 3 in 11%, 4 in 13%, and 5 in 13% of the limbs. There were 26 major amputations (14%) and 16 deaths (8.7%) within 6 months. Patients with MAC 5 had a significantly higher risk of major limb amputation than both the 0 to 1 and 2 to 4 groups (P = .001 and P = .044, respectively), and lower overall amputation-free survival (log-rank P = .008). CONCLUSIONS: Pedal MAC score is a reproducible and generalizable measure of inframalleolar arterial disease that can be used with Wound, Ischemia, and foot Infection staging to predict major limb amputation in patients with chronic limb-threatening ischemia.

Sex-based differences in outcomes after lower extremity bypass for chronic limb-threatening ischemia.

BACKGROUND AND AIMS: Lower extremity bypass surgery is an effective treatment option for patients with chronic limb-threatening ischemia (CLTI). Recent studies have suggested that sex-based differences may impact patient outcomes following lower extremity revascularization, however, results have been inconsistent. METHODS: In this multicenter analysis, we retrospectively identified all infrainguinal bypass procedures performed for CLTI from 2002 to 2021. Patients were separated into two groups based on sex. Primary outcomes were major limb amputation and reintervention for graft patency. RESULTS: Of 843 bypasses performed over the study period, 347 (41.2%) patients were female. Racial/ethnic distribution and medical comorbidities were similar across sex groups. Surgical indications and operative details were also similar between groups, including conduit type (49.9% autogenous), bypass target (65.4% infrageniculate), and concurrent endarterectomy (38.9%). Female and male patients had similar hospital length of stay (6 days [4-9] vs 6 days [4-9]), hospital readmission (25.6% vs 25.0%), and postoperative complications (p=NS each). Female patients had higher major amputation rates (10.1% vs 6.3%, p=0.04) after one year, whereas reintervention rates were similar between groups (26.2% vs 24.6%, p=NS). After accounting for patient factors, female sex (odds ratio [OR] 1.02 [1.00-1.04]), infrageniculate target (OR 1.02 [1.00-1.04]), and bypass for tissue loss (OR 1.02 [1.00-1.04]) were associated with major amputation after bypass (p<0.05 each). CONCLUSIONS: Female sex is associated with a small but significant increase major amputation after lower extremity bypass surgery for CLTI, despite similar clinical presentation, medical comorbidities, and operative details. These data support the increasingly recognized sex disparities in peripheral arterial disease.

Poor utilization of palliative care among Medicare patients with chronic limb-threatening ischemia.

OBJECTIVE: Patients with chronic limb-threatening ischemia (CLTI) experience high annual mortality and would benefit from timely palliative care intervention. We sought to better characterize use of palliative care among patients with CLTI in the Medicare population. METHODS: Using Medicare data from 2017 to 2018, we identified patients with CLTI, defined as two or more encounters with a CLTI diagnosis code. Palliative care evaluations were identified using ICD-10-CM Z51.5 "Encounter for palliative care." Time intervals between CLTI diagnosis, palliative consultation, and death or end of follow-up were calculated. Associations between patient demographics, comorbidities, and palliative care consultation were assessed. RESULTS: A total of 12,133 Medicare enrollees with complete data were categorized as having CLTI. Of these, 7.4% (894) underwent a palliative care evaluation at a median of 170 days (interquartile range, 45-352 days) from their CLTI diagnosis. Compared with those who did not undergo evaluation, palliative patients were more likely to be dual eligible for Medicaid (45.2% vs 38.1%; P < .001) and had more comorbid conditions (P < .001). After controlling for gender and race, age (odds ratio [OR], 1.03; 95% confidence interval [CI], 1.02-1.04), dual eligibility (OR, 1.40; 95% CI, 1.22-1.62), solid organ malignancy (OR, 2.82; 95% CI, 1.92-4.14), hematologic malignancy (OR, 2.24; 95% CI, 1.27-3.98), congestive heart failure (OR, 1.44; 95% CI, 1.15-1.88), complicated diabetes (OR, 1.35; 95% CI, 1.11-1.65), dementia (OR, 1.32; 95% CI, 1.04-1.66), and severe renal failure (OR, 1.56; 85% CI. 1.24-1.98) were independently associated with palliative care evaluation. During mean follow up of 410 ± 220 days, 16.9% (2044) of patients died at a mean of 268 (±189) days after their CLTI diagnosis. Among living patients, only 3.2% (325) underwent palliative evaluation. Comparatively, 27.8% (569) of patients who died received palliative care at a median of 196 days (interquartile range, 55-362 days) after their diagnosis and 15 days (interquartile range, 5-63 days) prior to death. CONCLUSIONS: Despite high mortality, palliative care services were rarely provided to Medicare patients with CLTI. Age, medical complexity, and income status may play a role in the decision to consult palliative care. When obtained, evaluations occurred closer to time of death than to time of CLTI diagnosis, suggesting misuse of palliative care as end-of-life care.

The management of patients with popliteal artery aneurysms presenting with acute limb ischemia.

OBJECTIVE: Endovascular popliteal artery aneurysm (PAA) repair has acceptable outcomes compared with open repair for elective therapy. Endovascular repair for urgent PAA causing acute limb ischemia (ALI) has not been well-studied. This project compares outcomes of urgent endovascular and open repair of PAA with ALI. METHODS: The Vascular Quality Initiative database for peripheral vascular interventions (PVIs) and infrainguinal bypass were reviewed for PAAs with ALI from 2010 to 2021. Only patients entered as having symptoms of ALI in the PVI module and ALI as indication in the infrainguinal bypass module were included. In addition, patients undergoing elective treatment were excluded and the sample analyzed was restricted to patients undergoing urgent and emergent open and endovascular repair. Patient demographics and comorbidities as well as procedural details were compared between the two groups. Perioperative complications up to 30 days were compared as well as long-term outcomes including major amputation and mortality at 1 year. RESULTS: Urgent PAA repair for ALI constituted 10.5% (n = 571) of all PAAs. Most urgent repairs were open (80.6%; n = 460) with 19.4% (n = 111) endovascular. The proportion of endovascular repair significantly increased from 16.7% in 2010 to 85.7% in 2021. Patients undergoing endovascular repair were older (71.2 ± 12.5 vs 68.0 ± 11.8; P = .011) than patients undergoing open repair. They were also more likely to have coronary artery disease (32.4% vs 21.7%; P = .006). Open PAA repair was associated with more bleeding complications (20.8% vs 2.7%; P < .001), longer postoperative length of stay (8.1 ± 9.3 days vs 4.9 ± 5.6 days; P < .001), and less likelihood of discharge to home (64.9% vs 70.3%; P = .051). Perioperative major amputation rate was 7.5% with no difference between the two treatment strategies up to 1 year. However, patients receiving endovascular repair had higher inpatient (1.1% vs 0%; P < .001), 30-day (6.3% vs 0.4%; P < .001), and 1-year (16.5% vs 8.4%; P = .02) mortality. Multivariable regression analysis suggested that endovascular repair was possibly associated with increased 30-day mortality, but not 1-year mortality. CONCLUSIONS: Endovascular PAA has exponentially increased from 2010 to 2021. Endovascular repair is associated with decreased complications and hospital length of stay. The increased perioperative mortality seen in this group is likely due to selection bias.

Risk Factors for Major Amputation in Chronic Limb-Threatening Ischemia Patients Classified as Wound, Ischemia, and Foot Infection Stage 4 following Infrainguinal Revascularization.

BACKGROUND: To evaluate limb salvage outcomes and risk factors for major amputation in chronic limb-threatening ischemia (CLTI) patients classified as stage 4 per the wound, ischemia, and foot infection (WIfI) classification following infrainguinal revascularization. METHODS: We retrospectively analyzed multicenter data of patients who had undergone infrainguinal revascularization for CLTI between 2015 and 2020. The endpoint was secondary major amputation defined as an above- or below-knee amputation following infrainguinal revascularization. RESULTS: We analyzed 243 patients with CLTI and 267 limbs. Bypass surgery was performed in 14 (25.5%) and 120 (56.6%) limbs from the secondary major amputation and limb salvage groups, respectively (P < 0.01). Endovascular therapy (EVT) was performed in 41 limbs (74.5%) in the secondary major amputation group and 92 limbs (43.4%) in the limb salvage group (P < 0.01). The average serum albumin levels were 3.0 ± 0.6 and 3.4 ± 0.5 g/dL in the secondary major amputation and limb salvage groups, respectively (P < 0.01). The percentage of congestive heart failure (CHF) was 36.4% and 14.2% in secondary major amputation and limb salvage groups, respectively (P < 0.01). The number of limbs with infra-malleolar (IM) P0, P1, and P2 were 4 (7.3%), 37 (67.3%), and 14 (25.5%), respectively, in the secondary major amputation group and 58 (27.4%), 140 (66.0%), and 14 (6.6%), respectively, in the limb salvage group (P < 0.01). Limb salvage rates at 1 year were 91.0% and 68.6% in the bypass and EVT groups, respectively (P < 0.01). Limb salvage rates at 1 year in patients with IM P0, P1, and P2 were 91.8%, 79.9%, and 53.1%, respectively (P < 0.01). Multivariate analysis revealed that serum albumin level [hazard ratio (HR), 0.56; 95% confidence interval (CI), 0.36-0.89; P = 0.01], hypertension (HR, 0.39; 95% CI, 0.21-0.75; P < 0.01), CHF (HR, 2.10; 95% CI, 1.09-4.05; P = 0.03), wound grade (HR, 1.72; 95% CI, 1.03-2.88; P = 0.04), IM P (HR, 2.08; 95% CI, 1.27-3.42; P < 0.01), and EVT (HR, 3.31; 95% CI, 1.77-6.18; P < 0.01) as independent risk factors for secondary major amputation being required. CONCLUSIONS: Among CLTI patients with WIfI stage 4, the limb salvage rate was poor in those with IM P1-2 following infrainguinal EVT. Low serum albumin levels, CHF, high wound grade, IM P1-2, and EVT were independent risk factors for CLTI patients requiring major amputation.

Impact of Revascularization Technique on the Outcomes of Peripheral Graft Revision Procedures.

BACKGROUND: The acute occlusion of a peripheral bypass graft leads to acute limb ischemia (ALI) and threatens the viability of the limb if left untreated. The aim of the present study was to analyze the results of surgical and hybrid revascularization techniques for patients with ALI due to peripheral graft occlusions. METHODS: A retrospective analysis of 102 patients undergoing treatment for ALI due to peripheral graft occlusion between 2002 and 2021 was carried out at a tertiary vascular center. Procedures were classified as surgical when only surgical techniques were used and as hybrid when surgical procedures were combined with endovascular techniques such as balloon or stent angioplasty or thrombolysis. Endpoints were primary and secondary patency and amputation-free survival after 1 and 3 years. RESULTS: Of all patients, 67 met the inclusion criteria, 41 were treated surgically and 26 by hybrid procedures. There were no significant differences in the 30-day patency rate, 30-day amputation rate, and 30-day mortality. The 1- and 3-year primary patency rates were 41.4% and 29.2% overall, respectively; 45% and 32.1% in the surgical group, respectively; and 33.2% and 26.6% in the hybrid group, respectively. The 1- and 3-year secondary patency rates were 54.1% and 35.8% overall, respectively; 52.5% and 34.2% in the surgical group, respectively; and 54.4% and 43.5% in the hybrid group, respectively. The 1- and 3-year amputation-free survival rates were 67.5% and 59.2%, overall, respectively; 67.3% and 67.3% in the surgical group, respectively; and 68.5% and 48.2% in the hybrid group, respectively. There were no significant differences between the surgical and the hybrid groups. CONCLUSIONS: The results of surgical and hybrid procedures after bypass thrombectomy for ALI to eliminate the cause of infrainguinal bypass occlusion are comparable with good midterm results in terms of amputation-free survival. New endovascular techniques and devices need to be established in comparison to the results of these proven surgical revascularization methods.