Transcatheter Arterialization of Deep Veins in Chronic Limb-Threatening Ischemia.

BACKGROUND: Approximately 20% of patients with chronic limb-threatening ischemia have no revascularization options, leading to above-ankle amputation. Transcatheter arterialization of the deep veins is a percutaneous approach that creates an artery-to-vein connection for delivery of oxygenated blood by means of the venous system to the ischemic foot to prevent amputation. METHODS: We conducted a prospective, single-group, multicenter study to evaluate the effect of transcatheter arterialization of the deep veins in patients with nonhealing ulcers and no surgical or endovascular revascularization treatment options. The composite primary end point was amputation-free survival (defined as freedom from above-ankle amputation or death from any cause) at 6 months, as compared with a performance goal of 54%. Secondary end points included limb salvage, wound healing, and technical success of the procedure. RESULTS: We enrolled 105 patients who had chronic limb-threatening ischemia and were of a median age of 70 years (interquartile range, 38 to 89). Of the patients enrolled, 33 (31.4%) were women and 45 (42.8%) were Black, Hispanic, or Latino. Transcatheter arterialization of the deep veins was performed successfully in 104 patients (99.0%). At 6 months, 66.1% of the patients had amputation-free survival. According to Bayesian analysis, the posterior probability that amputation-free survival at 6 months exceeded a performance goal of 54% was 0.993, which exceeded the prespecified threshold of 0.977. Limb salvage (avoidance of above-ankle amputation) was attained in 67 patients (76.0% by Kaplan-Meier analysis). Wounds were completely healed in 16 of 63 patients (25%) and were in the process of healing in 32 of 63 patients (51%). No unanticipated device-related adverse events were reported. CONCLUSIONS: We found that transcatheter arterialization of the deep veins was safe and could be performed successfully in patients with chronic limb-threatening ischemia and no conventional surgical or endovascular revascularization treatment options. (Funded by LimFlow; PROMISE II study ClinicalTrials.gov number, NCT03970538.).

Illness Trajectories After Revascularization in Patients With Peripheral Artery Disease: A Unified Approach to Understanding the Risk of Major Amputation and Death.

BACKGROUND: The aim of this study was to investigate the illness trajectories of patients with peripheral artery disease (PAD) after revascularization and estimate the independent risks of major amputation and death (from any cause) and their interaction. METHODS: Data from Hospital Episode Statistics Admitted Patient Care were used to identify patients (≥50 years of age) who underwent lower limb revascularization for PAD in England from April 2013 to March 2020. A Markov illness-death model was developed to describe patterns of survival after the initial lower limb revascularization, if and when patients experienced major amputation, and survival after amputation. The model was also used to investigate the association between patient characteristics and these illness trajectories. We also analyzed the relative contribution of deaths after amputation to overall mortality and how the risk of mortality after amputation was related to the time from the index revascularization to amputation. RESULTS: The study analyzed 94 690 patients undergoing lower limb revascularization for PAD from 2013 to 2020. The majority were men (65.6%), and the median age was 72 years (interquartile range, 64-79). One-third (34.8%) of patients had nonelective revascularization, whereas others had elective procedures. For nonelective patients, the amputation rate was 15.2% (95% CI, 14.4-16.0) and 19.9% (19.0-20.8) at 1 and 5 years after revascularization, respectively. For elective patients, the corresponding amputation rate was 2.7% (95% CI, 2.4-3.1) and 5.3% (4.9-5.8). Overall, the risk of major amputation was higher among patients who were younger, had tissue loss, diabetes, greater frailty, nonelective revascularization, and more distal procedures. The mortality rate at 5 years after revascularization was 64.3% (95% CI, 63.2-65.5) for nonelective patients and 33.0% (32.0-34.1) for elective patients. After major amputation, patients were at an increased risk of mortality if they underwent major amputation within 6 months after the index revascularization. CONCLUSIONS: The illness-death model provides an integrated framework to understand patient outcomes after lower limb revascularization for PAD. Although mortality increased with age, the study highlights patients <60 years of age were at increased risk of major amputation, particularly after nonelective revascularization.

Diabetic foot disease carries an intrinsic high risk of mortality and other severe outcomes in type 2 diabetes: a propensity score-matched retrospective population-based study.

BACKGROUND: To evaluate the association between diabetic foot disease (DFD) and the incidence of fatal and non-fatal events in individuals with type 2 diabetes (T2DM) from primary-care settings. METHODS: We built a cohort of people with a first DFD episode during 2010-2015, followed up until 2018. These subjects were 1 to 1 propensity score matched to subjects with T2DM without DFD. The incidence of all-cause mortality, the occurrence of new DFD, amputations, cardiovascular diseases, or composite outcome, including all-cause mortality and/or cardiovascular events during the follow-up period, were calculated. A Cox proportional hazard analysis was conducted to evaluate the hazard ratios (HR) for different events. RESULTS: Overall, 11,117 subjects with T2DM with a first episode of DFD were compared with subjects without DFD. We observed higher incidence rates (IRs) for composite outcome (33.9 vs. 14.5 IR per 100 person-years) and a new DFD episode event (22.2 vs. 1.1 IR per 100 person-years) in the DFD group. Compared to those without DFD, those with a first episode of DFD had a higher HR for all events, with excess rates particularly for amputation and new DFD occurrence (HR: 19.4, 95% CI: 16.7-22.6, HR: 15.1, 95% CI: 13.8-16.5, respectively) was found. CONCLUSIONS: Although DFD often coexists with other risk factors, it carries an intrinsic high risk of morbidity and mortality in individuals with T2DM. DFD should be regarded as a severe complication already at its onset, as it carries a poor clinical prognosis.

Prosthetic outcomes after amputation and the impact of mobility level on survival.

OBJECTIVE: Lower extremity amputation continues to be necessary in a significant number of patients with peripheral vascular disease. The 5-year survival following lower limb loss is markedly reduced. Many of these patients are never fitted with a prosthesis, and there is a dearth of knowledge regarding the barriers to prosthetic attainment. The goal of this study was to identify the risk factors for not receiving a prosthesis and the effect of mobility level on survival following major amputation. METHODS: This was a retrospective analysis of all patients that underwent lower extremity amputation by surgeons in our practice from January 1, 2010, to December 31, 2019. Abstracted data included: age, sex, race, body mass index, comorbidities, American Society of Anesthesiologists score, statin use, level of amputation, stump revision, fitting for prosthesis, type of prosthesis, and the United States' Medicare Functional Classification Level, also called K level. Survival was determined using a combination of sources, including the Social Security Death Master File, searches of multiple genealogic registries, and general internet searches. Multivariable logistic regression was used to determine risk factors associated with prosthesis attainment. Multivariable Cox proportional hazard regression with time-dependent covariates was performed to assess risk factors associated with 5-year mortality. RESULTS: A total of 464 patients were included in this study. The mean age was 65 years, and mean body mass index was 27 kg/m2. The majority of patients were male (68%), White (56%), diabetic (62%), and hypertensive (76%), and underwent below-the-knee amputation (69%). Prosthetic attainment occurred in 185 (40%). On multivariable analysis, age >81 years and current tobacco use were associated with no prosthetic fitting. Overall 5-year survival was 41.9% (95% confidence interval [CI], 37.6%-46.6%) (below-the-knee amputation, 47.7% [95% CI, 42.5%-53.5%]; above-the-knee amputation, 28.7% [95% CI, 22.1%-37.2%]). On multivariable analysis, age >60 years, congestive heart failure, above-the-knee amputation, and no prosthetic attainment were associated with decreased survival. Increasing K level was incrementally associated with improved survival. CONCLUSIONS: This study has identified several patient factors associated with prosthetic attainment, as well as multiple factors predictive of reduced survival after amputation. Being referred for prosthetic fitting was associated with improved survival not explained by patient characteristics and comorbidities. The Medicare Functional Classification Level K level predicts survival. More research is needed to determine the barriers to prosthetic attainment and if improving a patients K level will improve survival.

Prosthetic fitting and mortality after major lower extremity amputation.

BACKGROUND: Studies suggest that ambulation after major lower extremity amputation (LEA) is low and mortality after LEA is high. Successful prosthetic fitting after LEA has a significant quality of life benefit; however, it is unclear if there are benefits in post-LEA mortality. Our objective was to examine a contemporary cohort of patients who underwent LEA and determine if there is an association between fitting for a prosthetic and mortality. METHODS: We reviewed all patients who underwent LEA between 2015 and 2022 at two academic health care systems in a large metropolitan city. The exposure of interest was prosthetic fitting after LEA. The primary outcomes were mortality within 1 and 3 years of follow-up. Ambulation after LEA was defined as being ambulatory with or without an assistive device. Patients with prior LEA were excluded. Extended Cox models with time-dependent exposure were used to evaluate the association between prosthetic fitting and mortality at 1 and 3 years of follow-up. RESULTS: Among 702 patients who underwent LEA, the mean (SD) age was 64.3 (12.6) years and 329 (46.6%) were fitted for prosthetic. The study population was mostly male (n = 488, 69.5%), predominantly non-Hispanic Black (n = 410, 58.4%), and nearly one-fifth were non-ambulatory before LEA (n = 139 [19.8%]). Of note, 14.3% of all subjects who were nonambulatory at some point after LEA, and 28.5% of patients not ambulatory preoperatively were eventually ambulatory after LEA. The rate of death among those fitted for a prosthetic was 12.0/100 person-years at 1 year and 5.8/100 person-years at 3 years of follow-up; among those not fitted for a prosthetic, the rate of death was 55.7/100 person-years and 50.7/100 person-years at 1 and 3 years of follow-up, respectively. After adjusting for several sociodemographic data points, comorbidities, pre- or post- coronavirus disease 2019 pandemic timeframe, and procedural factors, prosthetic fitting is associated with decreased likelihood of mortality within 1 year of follow-up (adjusted hazard ratio, 0.24; 95% confidence interval, 0.14-0.40) as well as within 3 years (adjusted hazard ratio, 0.40; 95% confidence interval, 0.29-0.55). CONCLUSIONS: Prosthetic fitting is associated with improved survival, and preoperative functional status does not always predict postoperative functional status. Characterizing patient, surgical, and rehabilitation factors associated with receipt of prosthetic after LEA may improve long-term survival in these patients. Process measures employed by the Department of Veterans Affairs, such as prosthetic department evaluation of all amputees, may represent a best practice.

Comparison of mortality and amputation after lower extremity bypass versus peripheral vascular intervention in patients with chronic limb-threatening ischemia and comorbid chronic kidney disease.

OBJECTIVE: Comorbid chronic kidney disease (CKD) is associated with worse outcomes for patients with chronic limb-threatening ischemia (CLTI). However, comparative effectiveness data are limited for lower extremity bypass (LEB) vs peripheral vascular intervention (PVI) in patients with CLTI and CKD. We aimed to evaluate (1) 30-day all-cause mortality and amputation and (2) 5-year all-cause mortality and amputation for LEB vs PVI in patients with comorbid CKD. METHODS: Individuals who underwent LEB and PVI were queried from the Vascular Quality Initiative with Medicare claims-linked outcomes data. Propensity scores were calculated using 13 variables, and a 1:1 matching method was used. The mortality risk at 30 days and 5 years in LEB vs PVI by CKD was assessed using Kaplan-Meier and Cox proportional hazards models, with interaction terms added for CKD. For amputation, cumulative incidence functions and Fine-Gray models were used to account for the competing risk of death, with interaction terms for CKD added. RESULTS: Of 4084 patients (2042 per group), the mean age was 71.0 ± 10.8 years, and 69.0% were male. Irrespective of CKD status, 30-day mortality (hazard ratio [HR]: 0.94, 95% confidence interval [CI]: 0.63-1.42, P = .78) was similar for LEB vs PVI, but LEB was associated with a lower risk of 30-day amputation (sub-HR [sHR]: 0.66, 95% CI: 0.44-0.97, P = .04). CKD status, however, did not modify these results. Similarly, LEB vs PVI was associated with a lower risk of 5-year mortality (HR: 0.79, 95% CI: 0.71-0.88, P < .001) but no difference in 5-year amputation (sHR: 1.03, 95% CI: 0.89-1.20, P = .67). CKD status did not modify these results. CONCLUSIONS: Regardless of CKD status, patients had a lower risk of 5-year all-cause mortality and 30-day amputation with LEB vs PVI. Results may help inform preference-sensitive treatment decisions on LEB vs PVI for patients with CLTI and CKD, who may commonly be deemed too high risk for surgery.

Editor's Choice - Analysis of Lower Limb Amputations in Brazil's Public Health System over 13 Years.

OBJECTIVE: Understanding the causes of amputation is crucial for defining health policies that seek to avoid such an outcome, but only a few studies have investigated the epidemiology of patients submitted to amputations in developing countries. The objective of this study was to analyse all lower limb amputations performed in the public health system in Brazil over a 13 year period, evaluating trends in the number of cases, patient demographics, associated aetiologies, hospital length of stay, and in hospital mortality rate. METHODS: This was a retrospective, population based analysis of all lower limb amputations performed in the Brazilian public health system between 1 January 2008 and 31 December 2020. Using a public database, all types of amputations were selected, defining the number of procedures, their main aetiologies, anatomical level of limb loss, demographic data, regional distribution, and other variables of interest. RESULTS: A total of 633 455 amputations were performed between 2008 and 2020, mostly (55.6%) minor amputations, predominantly in males (67%). There was an upward trend in the number of amputations, determined mainly by the increase in major amputations (50.4% increase in the period). Elderly individuals have the highest rates of amputation. Diabetes mellitus (DM) is becoming the main primary diagnosis associated with amputations over the years. The highest in hospital mortality rate occurred after major amputations and was associated with peripheral arterial disease (PAD). CONCLUSION: Amputation rates in Brazil show an upward trend. DM is becoming the most frequent associated primary diagnosis, although PAD is the diagnosis most associated with major amputations and in hospital death.

The impact of the Affordable Care Act Medicaid Expansion in Medicare beneficiaries with peripheral artery disease.

Background: In 2014, the Affordable Care Act Medicaid Expansion (ME) increased Medicaid eligibility for adults with an income level up to 138% of the federal poverty level. In this study, we examined the impact of ME on mortality and amputation in patients with peripheral artery disease (PAD). Methods: The 100% MedPAR and Part-B Carrier files from 2011 to 2018 were queried to identify all fee-for-service Medicare beneficiaries with PAD using International Classification of Diseases codes. Our primary exposure was whether a state had adopted the ME on January 1, 2014. Our primary outcomes were the change in all-cause 1-year mortality and leg amputation. We used a state-level difference-in-differences (DID) analysis to compare the rates of the primary outcomes among patients who were in states (including the District of Columbia) who adopted ME (n = 25) versus those who were in states that did not (n = 26). We performed a subanalysis stratifying by sex, race, region, and dual-eligibility status. Results: Over the 8-year period, we studied 37,743,929 patients. The average unadjusted 1-year mortality decreased from 2011 to 2018 in both non-ME (9.5% to 8.7%, p < 0.001) and ME (9.1% to 8.3%, p < 0.001) states. The average unadjusted 1-year amputation rate did not improve in either the non-ME (0.86% to 0.87%, p = 0.17) or ME (0.69% to 0.69%, p = 0.65) states. Across the entire cohort, the DID model revealed that ME did not lead to a significant change in mortality (p = 0.15) or amputation (p = 0.34). Conclusion: Medicaid Expansion was not associated with reduced mortality or leg amputation in Medicare beneficiaries with PAD.

Risk Factors for Mortality and Promoting Factors for Ambulation After Major Lower Limb Amputation for End-Stage Arterial Disease: A Multicenter Study.

BACKGROUND: Around 1%-2% of patients with peripheral arterial disease will require a lower limb amputation at some point. Despite advancements in prevention and treatment, mortality after major amputation remains high. The aim of this study was to investigate the risk factors related to mortality and promoting factors for ambulation postamputation. METHODS: A multicenter retrospective study of consecutive major lower limb amputation patients performed at the department of thoracic and vascular surgery of the University Hospitals Ghent and Leuven between January 2008 and December 2017. RESULTS: Three hundred and thirteen patients met the inclusion criteria. Overall, 1-year mortality rate was 29.7% with age being the most important risk factor. Above-knee amputations had significantly higher mortality (37%) than below-knee amputations (22%) at 1 year. Diabetes and number of vascular interventions were not linked to higher mortality. Age, amputation level, and presence of hypertension were the most important determining factors for successful ambulation. CONCLUSIONS: Maintaining the independency of patients, whether this is obtained by maximizing limb salvage or primary amputation, is critical. Knowledge about the factors that play a role in the risk of death and the chance of regaining ambulation is important to include in the decision-making conversation with the patient.

Factors Associated with Urgent Amputation Status and Its Impact on Mortality.

BACKGROUND: Thirty-day mortality is higher after urgent major lower extremity amputations compared to elective lower extremity amputations. This study aims to identify factors associated with urgent amputations and to examine their impact on perioperative outcomes and long-term mortality. METHODS: Patients undergoing major lower limb amputation from 2013 to 2020 in the Vascular Quality Initiative were included. Urgent amputation was defined as occurring within 72 hr of admission. Associations with sociodemographic characteristics, comorbidities, and outcomes including postoperative complication, inpatient death, and long-term survival were compared using univariable tests and multivariable logistic regression. Long-term survival between groups was compared using Kaplan-Meier analysis. RESULTS: Of the 12,874 patients included, 4,850 (37.7%) had urgent and 8,024 (62.3%) had elective amputations. Non-White patients required urgent amputation more often than White patients (39.8% vs. 37.9%, P = 0.03). A higher proportion of Medicaid and self-pay patients presented urgently (Medicaid: 13.0% vs. 11.0%; self-pay: 3.4% vs. 2.5%, P < 0.001). Patients requiring urgent amputation were less often taking aspirin (55.6% vs. 60.1%, P < 0.001) or statin (62.2% vs. 67.2%, P < 0.001), had fewer prior revascularization procedures (41.0% vs. 48.8%, P < 0.001), and were of higher American Society of Anesthesiologists (ASA) class 4-5 (50.9% vs. 40.1%, P < 0.001). Urgent amputations were more commonly for uncontrolled infection (48.1% vs. 29.4%, P < 0.001) or acute limb ischemia (14.3% vs. 6.2%, P < 0.001). Postoperative complications were higher after urgent amputations (34.7% vs. 16.6%, P < 0.001), including need for return to operating room (23.8% vs. 8.4%, P < 0.001) and need for higher revision (15.2% vs. 4.5%, P < 0.001). Inpatient mortality was higher after urgent amputation (8.9% vs. 5.4%, P < 0.001). Multivariable analysis revealed non-White race, self-pay, homelessness, current smoking, ASA class 4-5, and amputations for uncontrolled infection or acute limb ischemia were associated with urgent status, whereas living in a nursing home or prior revascularization were protective. Furthermore, urgent amputation was associated with an increased odds of postoperative complication or death (odds ratio 1.86 [1.69-2.04], P < 0.001) as well as long-term mortality (odds ratio: 1.24 [1.13-1.35], P < 0.001). Kaplan-Meier analysis corroborated that elective status was associated with improvement of long-term survival. CONCLUSIONS: Patients requiring urgent amputations are more often non-White, uninsured, and less frequently had prior revascularization procedures, revealing disparities in access to care. Urgency was associated with a higher postoperative complication rate, as well as increased long-term mortality. Efforts should be directed toward reducing these disparities to improve outcomes following amputation.

Risk Factors for Lower Extremity Minor Amputation Conversion to Major Amputation.

BACKGROUND: Minor lower extremity amputations (LEAs) have become an important part of the limb salvage approach but are not as benign as previously thought. This study investigates the difference in outcome between toe/ray versus midfoot amputations and the risk factors for major amputation conversion associated with each procedure. METHODS: We performed retrospective chart review of foot amputation patients at a single tertiary care medical center with a primary end point of conversion to major amputation and secondary end points of 1-year wound healing and mortality rate. We collected data on relevant medical comorbidities, noninvasive vascular imaging, revascularization, repeat amputations, wound healing rate, and 1-year mortality. Patients were separated into toe/ray amputations versus midfoot amputation groups and compared using descriptive statistics, Chi-squared tests, Cox proportional hazards, and a multivariate logistic regression model. RESULTS: A total of 375 amputations were included in the analysis. 65.3% (245 patients) included toe/ray amputations and 34.7% (130 patients) included midfoot amputations. We compared these 2 cohorts with regard to their rate of conversion to repeat minor and/or major amputation in addition to overall mortality. The toe/ray group underwent more repeat minor amputations within 1 year after index amputation (34.7% vs. 21.5%, P = 0.008) and wound healing (epithelization) at 90 days was also higher in this group. The midfoot group had a higher conversion to major LEA within 1 year on univariate analysis (20.8 vs. 6.9%, P < 0.001). Overall 1-year mortality was 6.17% and there was no significant difference between groups. CONCLUSIONS: While there is a consistency with previous studies that found no significant overall difference in mortality between types of minor LEA, we have extended this previous work by demonstrating the independent risk factors for conversion to major amputation between types of minor LEA. Comparing these 2 groups will assist surgeons in choosing the appropriate level of amputations and will enhance patient's understanding of their chance of wound healing and risk of repeat amputation.

Moderate and Severe Chronic Kidney Disease Predict Greater 5-Year Mortality following Major Lower-Extremity Amputation.

BACKGROUND: Severe chronic kidney disease (CKD) predicts greater mortality after major lower-extremity amputation (LEA), but it remains poorly understood whether patients with earlier stages of CKD share similar risk. METHODS: We assessed long-term postoperative outcomes for patients with CKD in a retrospective chart review of 565 patients who underwent atraumatic major LEA at a large tertiary referral center from 2015 to 2021. We stratified patients by renal function and compared outcomes including survival. RESULTS: Preoperative CKD diagnosis was related to many patient characteristics, co-occurred with many comorbidities, and was associated with less follow-up and survival. Kaplan-Meier and Cox Regression analyses showed significantly worse 5-year survival for major LEA patients with mild, moderate, or severe CKD compared to major LEA patients with no history of CKD at the time of amputation (P < 0.001). Severe CKD independently predicted worse mortality at 1-year (odds ratio [OR] 2.91; P = 0.003) and 5-years (OR 3.08; P < 0.001). Moderate CKD independently predicted worse 5-year mortality (OR 2.66; P = 0.029). CONCLUSIONS: This study demonstrates that moderate and severe CKD predict greater long-term mortality following major LEA when controlling for numerous potential confounders. This finding raises questions about the underlying mechanism if causal and highlights an opportunity to improve outcomes with earlier recognition and optimization CKD preoperatively.

Delayed Closure of Guillotine Lower Extremity Amputation in Obese Patients is Associated with Increased Mortality.

BACKGROUND: Staged surgery with open guillotine amputation (OGA) prior to a definitive major lower extremity amputation (LEA) has been shown to be effective for sepsis control and improving wound healing. Studies have evaluated postoperative complications including infection, return to the operating room for re-amputation, and amputation failure following OGA. However, the role of timing to close OGA for predictive outcomes remains poorly understood. We aim to assess outcomes of major LEA related to the time of OGA closure. METHODS: Data from patients who underwent major LEA from 2015 to 2021 were collected retrospectively. The study included all patients undergoing below-knee, through-knee, or above-knee amputations. Next, patients who had OGA prior to a definitive amputation were selected. Patients who died before amputation closure were excluded. Postamputation outcomes such as surgical site infection, postoperative sepsis, postoperative ambulation, hospital length of stay, and 30-day, 1-year, and 5-year mortality were reviewed. The study cohort was stratified by demographics and comorbidities. Receiver operating characteristic curve analysis was performed to determine the time of closure (TOC) cutoff value. Univariate and multivariate analysis was performed to assess outcomes. Statistical significance was set at P < 0.05. RESULTS: Of 688 patients who underwent major LEA, 322 underwent staged amputation with OGA before the formalization procedure and were included. The TOC ranged from 1-47 days with a median of 4 days (interquartile range from 3 to 7). The optimal TOC point of 8 days (ranging from 2-42 days) in obese patients (199/322) for predicting mortality showed the largest area under the curve (0.709) with 64.71% sensitivity and 78.3% specificity. Patients who are obese and grouped in TOC less than 8 days had no 30-day mortality, significantly lower 1-year mortality, better survival, and a lower rate of deep venous thrombosis complication. There was no significant difference in length of stay, postoperative surgical site infection, sepsis, and ambulation between the 2 subgroups of obese patients. Multivariable analysis showed that gender, chronic kidney disease, and postoperative ambulation independently predict overall mortality in obese patients. CONCLUSIONS: TOC cutoff in obese patients showed statistically significant results in predicting mortality. Our findings indicated better survival in obese patients with a lower TOC (less than 8 days). This emphasizes the importance of earlier closure of OGA in obese patients.

Regional Anesthesia is Associated with Improved Mortality and Morbidity in Patients with Congestive Heart Failure Undergoing Lower Extremity Amputation.

BACKGROUND: While existing literature reports variable results of general anesthesia (GA) and regional anesthesia (RA) in patients undergoing lower extremity amputation (LEA), the effect of RA on patients with congestive heart failure (CHF) has not been explored. This study aims to assess whether the choice of anesthesia plays a role in influencing outcomes within this vulnerable population. METHODS: Using the American College of Surgeons National Surgical Quality Improvement Program files between 2005 and 2022, all patients receiving LEA were identified, and the subset of patients with CHF was included. Patient characteristics and 30-day outcomes were compared using χ2 or Fischer's exact test as appropriate for categorical variables and the independent t-test or Mann-Whitney U test as appropriate for continuous variables. The association between anesthesia modality and post-operative outcomes was studied using multivariable logistic regression analysis. RESULTS: A total of 5,831 patients (4,779 undergoing GA, 1,052 undergoing RA) with a diagnosis of CHF undergoing LEA were identified. On multivariable logistic regression analysis, RA was associated with lower mortality (adjusted odds ratio [aOR] 0.79, 95% CI 0.65-0.97), pneumonia (aOR 0.76, 95% CI 0.58-0.99), septic shock (aOR 0.64, 95% CI 0.47-0.88), post-operative blood transfusion (aOR 0.82, 95% CI 0.70-0.97), and 30-day readmission (aOR 0.79, 95% CI 0.64-0.97). CONCLUSIONS: This study demonstrates that RA for LEA in patients with CHF is associated with decreased morbidity and mortality compared to GA. While furthermore research is needed to confirm this association, RA should be at least considered in CHF patients undergoing LEA when feasible.

Socioeconomic status affects amputation and mortality rates in necrotizing fasciitis patients.

PURPOSE: Necrotizing fasciitis (NF) is a rare, but rapidly progressing bacterial infection of the subcutaneous tissues and muscular fascia with high rates of morbidity and mortality. Our study aims to determine if socioeconomic status (SES) is a predictor of outcomes in NF. METHODS: A retrospective review was conducted of patients diagnosed with NF at our institution. Demographic information, insurance status, medical and surgical history, vitals, ASA score, blood laboratory values, surgical procedure information, and outcomes prior to patient discharge were collected. Patient zip codes were utilized to obtain median household incomes at the time of the patient's surgical procedure to determine SES. Patients without complete data in their medical record were excluded. Initial descriptive statistics and logistic regression models were performed. RESULTS: We identified 196 patients (mean age 50.13 ± 13.03 years, 31.6% female) for inclusion. Mortality rate was 15.3% (n = 30) and 33.7% (n = 66) underwent amputation. Mortality rate was not significantly different across income brackets. Lower income brackets had higher rates of amputation than higher income brackets (p < 0.05). A logistic regression models showed the rate of amputation decreases by 29% for every $10,000 increment in median household income and ASA score decreased by 0.15 units for every $10,000 increase in median household income. CONCLUSIONS: Amputation rates in cases of NF are significantly higher in lower SES groups than higher SES groups. Patients with perivascular disease in lower SES groups were more likely to experience serious complications of NF than their counterparts in higher SES groups.

Mortality after major lower extremity amputation and association with index level: a cohort study based on 11,205 first-time amputations from nationwide Danish databases.

BACKGROUND AND PURPOSE: Mortality after major lower extremity amputations is high and may depend on amputation level. We aimed to examine the mortality risk in the first year after major lower extremity amputation divided into transtibial and transfemoral amputations. METHODS: This observational cohort study used data from the Danish Nationwide Health registers. 11,205 first-time major lower extremity amputations were included from January 1, 2010, to December 31, 2021, comprising 3,921 transtibial amputations and 7,284 transfemoral amputations. RESULTS: The 30-day mortality after transtibial amputation was overall 11%, 95% confidence interval (CI) 10-12 (440/3,921) during the study period, but declined from 10%, CI 7-13 (37/381) in 2010 to 7%, CI 4-11 (15/220) in 2021. The 1-year mortality was 29% overall, CI 28-30 (1,140 /3,921), with a decline from 31%, CI 21-36 (117/381) to 20%, CI 15-26 (45/220) during the study period. For initial transfemoral amputation, the 30-day mortality was overall 23%, CI 22-23 (1,673/7,284) and declined from 27%, CI 23-31 (138/509) to 22%, CI 19-25 (148/683) during the study period. The 1-year mortality was 48% overall, CI 46-49 (3,466/7,284) and declined from 55%, CI 50-59 (279/509) to 46%, CI 42-50 (315/638). CONCLUSION: The mortality after major lower extremity amputation declined in the 12-year study period; however, the 1-year mortality remained high after both transtibial and transfemoral amputations (20% and 46% in 2021). Hence, major lower extremity amputation patients constitute one of the most fragile orthopedic patient groups, emphasizing an increased need for attention in the pre-, peri-, and postoperative setting.

Utilizing the Frailty Index to Predict Long-term Mortality in Patients Undergoing Major Lower Extremity Amputation.

The 5-factor modified Frailty Index (mFI-5) is a risk-stratification tool utilized to predict complications and mortality following major lower extremity (LE) amputation. However, its prognostic value for long-term mortality is unknown. The study aim was to assess whether a high mFI-5 score relates to long-term mortality following major LE amputation for chronic wounds. Patients ≥60 years who underwent major LE amputation from 2017 to 2021 were retrospectively reviewed. Data regarding demographics, comorbidities, perioperative factors, amputation type, and postoperative complications was collected and mFI-5 was calculated. Survival analysis was performed with Kaplan-Meier curves and differences were assessed with Log-Rank test. A total of 172 patients were identified. Mean age was 70.7 ± 8.0 years. Median time to ambulation was 3.7 months (IQR 4.0). By final follow-up of 17.5 ± 15.9 months, ambulatory rate was 51.7% (n = 89), overall mortality 36.0% (n = 62), 1-year mortality 14.0% (n = 24), and 3-year mortality 27.9% (n = 48). Patients with an mFI-5 of ≥4 (26.7%, n = 46) compared with patients with mFI-5 <4 (73.3%, n = 126) had a higher rate of prolonged postoperative LOS (34.8% vs 19.8%, p = .042), overall mortality (52.2% vs 30.2%, p = .008), 1-year mortality (23.9% vs 10.3%, p = .023), and 3-year mortality (45.7% vs 21.4%, p = .002). Multivariate analysis demonstrated mFI-5 was an independent predictor of 3-year mortality (OR 2.35, p = .043). At a threshold ≥4, the mFI-5 demonstrated utility in predicting long-term mortality. The value of this prognostic indicator is in its preoperative application of assessing risk of mortality, which should be utilized in conjunction with other measures.

Peripheral Artery Disease Leading to Major Amputation: Trends in Revascularization and Mortality Over 18 Years.

BACKGROUND: Patients with peripheral artery disease (PAD) are at risk for amputation. The aim of this study was to assess the type of revascularization prior to and the 30-day mortality rate after major amputation due to PAD. METHODS: Retrospective analysis of consecutive patients undergoing major amputation for PAD between 01/2000 and 12/2017 at a tertiary referral center. The number and target level of ipsilateral revascularizations prior to amputation were analyzed per patient and over the years. There were 3 types of revascularization (open, endovascular and combined treatment) at 3 levels: aortoiliac, femoropopliteal and infrapopliteal. Univariate and multivariate logistic regression models were used to assess the association of level of amputation and patient characteristics with 30-day mortality. RESULTS: A total of 312 patients (65.7% male) with a mean age of 73.3 ± 11 years underwent 338 major amputations: 70 (21%) above/through knee and 268 (79%) below knee. A median of 2 (interquartile range, IQR 1-4) revascularizations were performed prior to amputation, with a slight decrease of 1.4% per year from 2000-2017 (incidence rate ratio of 0.986 0.974-0.998; Poisson regression analysis, P = 0.021). 16% (53/338) of patients underwent primary amputation without revascularization; this number remained relatively stable throughout the study period. The proportion of exclusively open treatment before amputation decreased substantially from 35% in 2006 to none in 2016, while exclusively endovascular revascularizations were performed increasingly from 17% in 2002 to 64% in 2016. Amputation occurred after a median of 9.5 months (IQR 0.9-67.6 months) if the first revascularization was aortoiliac or femoropopliteal and after 2.1 months (IQR 0.5-13.8 months) if the first intervention was infrapopliteal (P < 0.001) with no significant change over the years (normal linear regression, P= 0.887). Thirty-day mortality was 8.9% (22/247) after below knee and 27.7% (18/65) after above/through knee amputation (adjusted OR 3.84, 95% CI 1.74-8.54, P= 0.001) with a slight increase of mortality over the study period (adjusted OR 1.09, 95% CI 1.018-1.159, Poisson regression analysis, P= 0.021). The uni- and multivariate analysis of patient characteristics did not show an association with mortality, except higher ASA classification (adjusted OR 2.65, 95% CI 1.23-5.72, P= 0.012). CONCLUSIONS: Mortality, especially after above/through knee amputation, remains high over the past 2 decades. There is a clear shift towards endovascular treatment of patients with PAD prior to major amputation. In patients needing infrapopliteal revascularizations, amputation was performed much sooner than in those with aortoiliac or femoropopliteal interventions, with no improvement over the years. Strategies to extend limb salvage in these patients should be the focus of further research.

The Impact of Anemia on One-Year Amputation-Free Survival in Patients Undergoing Revascularization for Chronic Limb-Threatening Ischemia: A Retrospective Cohort Study.

BACKGROUND: Anemia is potentially associated with increased morbidity and mortality following vascular surgery procedures. This study investigated whether peri-procedural anemia is associated with reduced 1-year amputation-free survival (AFS) in patients undergoing revascularization for chronic limb-threatening ischemia (CLTI). METHODOLOGY: A retrospective analysis of patients diagnosed with CLTI between February 2018-February 2019, who subsequently underwent revascularization, was conducted. Hemoglobin concentration measured at index assessment was recorded and stratified by WHO criteria. Subsequent peri-procedural red blood cell transfusions (RBC) were also recorded. The primary outcome was 1-year AFS. Kaplan Meier survival analysis and Cox's proportional hazard modelling were conducted to assess the effect of anemia and peri-procedure transfusion on outcomes. RESULTS: 283 patients were analyzed, of which 148 (52.3%) were anemic. 53 patients (18.7%) underwent RBC transfusion. Patients with anemia had a significantly lower 1-year AFS (64.2% vs. 78.5%, P = 0.009). A significant difference in 1-year AFS was also observed based upon anemia severity (P = 0.008) and for patients who received RBC transfusion (45.3% vs 77.0%, P < 0.001). On multivariable analysis, moderately severe anemia was independently associated with increased risk of major amputation/death (aHR 1.90, 95% CI 1.06-3.38, P = 0.030). After adjusting for severity of baseline anemia, peri-procedural RBC transfusion was associated with a significant increase in the combined risk of major amputation/death (aHR 3.15, 95% CI 1.91-5.20, P < 0.001). CONCLUSION: Moderately severe peri-procedural anemia and subsequent RBC transfusion are independently associated with reduced 1-year AFS in patients undergoing revascularization for CLTI. Future work should focus on investigating alternative measures to managing anemia in this cohort.

The Timing of Limb Amputation in Nontraumatic Patients: Impact on Mortality and Postoperative Complication Rates.

Diabetes and peripheral vascular diseases are accompanied frequently by lower limb ischemia and in minority, need for amputation, as a treatment of last resort. Even after a decision has been made regarding amputation, the procedures are often repeatedly postponed due to more urgent surgeries and lack of operating room availability. This study assessed the possible relationship between the duration of time inpatients wait for semiurgent amputations and the incidence of postamputation complications. A retrospective cohort, including all 360 adult patients who underwent nontraumatic limb amputation due to an ischemic/gangrenous/infected foot in a single center during an 11-year period (2007-2017). Most (96%) of the procedures were major amputations. The mean waiting time until amputation was 3 ± 5 days. Mortality during hospitalization occurred in 101 (28%) patients and re-amputation in 38 (11%). The duration of antibiotic treatment was 11 ± 14 days. The rate of sepsis was 30% (107/360). There was no significant difference between the duration of time until amputation and mortality during hospitalization: among those who waited ≤48 hours, the mortality rate was 27% (60/224) and among those who waited >48 hours 30% (41/136) (p = .5). Patients waiting ≤48 hours had higher re-amputation rates than those waiting >48 (31/223 (14%) vs 7/136 (5%), p = .009). Mortality was associated significantly to patients' age and renal function. Correlation was found between the waiting time until amputation (≤48 or >48 hours) and the rates of in-hospital mortality, sepsis, duration of antibiotic treatment and overall duration of hospitalization. Re-amputation rate was higher in group with the shorter waiting time. This correlation may be explained by the fact that patients who needed urgent amputation had a more extensive and severe disease, and thus tended to require more re-amputation operations.