Major Lower Extremity Amputation Research Articles

Current Status and Principles for the Treatment and Prevention of Diabetic Foot Ulcers in the Cardiovascular Patient Population: A Scientific Statement From the American Heart Association.

Despite the known higher risk of cardiovascular disease in individuals with type 2 diabetes, the pathophysiology and optimal management of diabetic foot ulcers (DFUs), a leading complication associated with diabetes, is complex and continues to evolve. Complications of type 2 diabetes, such as DFUs, are a major cause of morbidity and mortality and the leading cause of major lower extremity amputation in the United States. There has recently been a strong focus on the prevention and early treatment of DFUs, leading to the development of multidisciplinary diabetic wound and amputation prevention clinics across the country. Mounting evidence has shown that, despite these efforts, amputations associated with DFUs continue to increase. Furthermore, due to increasing patient complexity of management secondary to comorbid conditions, such as cardiovascular disease, the management of peripheral artery disease associated with DFUs has become increasingly difficult, and care delivery is often episodic and fragmented. Although structured, process-specific approaches exist at individual institutions for the management of DFUs in the cardiovascular patient population, there is insufficient awareness of these principles in the general medicine communities. Furthermore, there is growing interest in better understanding the mechanistic underpinnings of DFUs to better define personalized medicine to improve outcomes. The goals of this scientific statement are to provide salient background information on the complex pathogenesis and current management of DFUs in cardiovascular patients, to guide therapeutic and preventive strategies and future research directions, and to inform public policy makers on health disparities and other barriers to improving and advancing care in this expanding patient population.

Modified Frailty Index Helps Predict Mortality and Ambulation Differences Between Genders and Racial Differences Following Major Lower Extremity Amputation.

Major lower extremity amputation (LEA) is associated with significant morbidity and mortality. The modified frailty index (mFI-5) has been used to predict outcomes including ambulation and mortality after LEA. It remains unknown for which patient demographics the mFI-5 is a reliable predictor. This was a retrospective review of all patients who underwent a first-time major LEA at our institution from 2015 to 2022. Patients were stratified into 2 risk groups based on their mFI-5 score: non-frail (mFI<3) and frail (mFI≥3) and assessed on outcomes. Our sample consisted of 687 patients of whom 134 (19.6%) were considered frail and 551 (80.4%) were considered non-frail. A higher mFI-5 is associated with decreased ambulation rates (OR: 0.565, P = .004), increased hospital readmission (OR: 1.657, P = .021), and increased mortality (OR: 2.101, P = .001) following major LEA. In African American patients, frail and non-frail patients differed on readmission at 90 days (P = .008), mortality at 1 year (P = .001), ambulatory status (P < .001), and prosthesis use (P = .023). In male patients, frail and non-frail patients differed on readmission at 90 days (P = .019), death at 1 year (P = .001), and ambulatory status (P = .002). In Caucasian patients and female patients, frail and non-frail patients did not differ significantly on outcomes. The mFI-5 is a valuable predictor of outcomes following major LEA, specifically in males and African American patients. Moreover, surgeons should consider using frailty status to risk stratify patients and inform treatment plans.

Opioid Use Disorder in Patients Undergoing Major Lower Extremity Amputation: Prevalence and Outcomes.

Patients with a history of Opioid Use Disorder (OUD) have higher postoperative complication rates and mortality in many settings. Yet, it remains poorly understood how the opioid epidemic has affected patients undergoing major lower extremity amputation (LEA) and whether outcomes differ by OUD status. We conducted a retrospective chart review of all 689 patients who underwent major LEA at a large tertiary referral center from 2015 to 2021. This study assessed patient characteristics and long-term postoperative outcomes for patients with preoperative OUD. 133 (19.3%) patients had a lifetime history of preoperative OUD. Preoperative OUD was associated with key characteristics, comorbidities, and outcome measures. OUD was significantly associated with younger age (P < .001), black race (P = .026), single relationship status (P < .001), BMI <30 (P = .024), no primary care provider (P = .004), and Medicaid insurance (P < .001). Comorbidities significantly associated with OUD include current smoking (P < .001), Human Immunodeficiency Virus (HIV; P = .003), and history of osteomyelitis (P < .001). Preoperative OUD independently predicted lower rates of 30-60-day readmission (odds ratio [OR] .54, P = .018) and 1-12-month reamputation (OR .41, P = .006). There was no significant difference in long-term mortality and follow-up. This study demonstrates the prevalence of OUD in patients undergoing major LEA and reports associations and long-term outcomes. Our findings highlight the importance of recognizing OUD and raise questions about the mechanisms underlying its relation to rates of postoperative readmission and reamputation.

The impact of comorbidities on mortality in patients with non-traumatic major lower extremity amputation

Objective: Major lower limb amputation is generally associated with a high risk of early and late-term mortality. In this study, 30-day, one-year and three-year mortality of non-traumatic major lower extremity amputations and comorbidities affecting the mortality rate were investigated. Method: Patients who underwent a major lower limb amputation secondary to diabetes or peripheral artery disease between the years 2010–2015 were retrospectively evaluated. Additional to patient demographic data and comorbidities, amputation level, survival and mortality time were extracted. Mortality rates after 30 days, one year and three years were analysed. The associations of the survival to different parameters were evaluated with Kaplan–Meier analysis and log rank test, while the impact of the risk factors on mortality was evaluated with the Cox regression test. Results: A total of 193 patients were enrolled in the study. Approximately 60% of patients were aged ≥65 years, and 65.8% were male. Below-knee amputation was performed in 64.8% of patients and above-knee amputation in 35.2% of patients. The mean follow-up of patients was 29.48 months (range: 0–101 months). After non-traumatic major lower extremity amputation, 30-day, one-year and three-year mortality were 16.6%, 38.3% and 60.1%, respectively. On Cox regression analysis, age ≥65 years was the only variable that had significant impact on the 30-day mortality (hazard ratio (HR): 3.4; p=0.012), while age ≥65 years (HR: 2.5, p=0.000), diabetes (HR: 2, p=0.006) and renal failure (HR: 2, p=0.001) were found to have significant impacts on three-year mortality. Conclusion: The findings of this study showed that &gt;50% of patients with non-traumatic major lower limb amputations died within three years. Advanced age, diabetes and renal failure were the risk factors that increased the mortality. The high mortality rates revealed the importance of employing all hard-to-heal wound treatment options before making an amputation decision. Further, prospective studies are needed to determine the effects of primary disease status and timing of amputation on mortality.

Regional and racial disparities in major amputation rates among medicare beneficiaries with diabetes: a retrospective study in the southeastern USA

ObjectiveWhile rates for non-traumatic lower extremity amputations (LEA) have been declining, concerns exist over disparities. Our objectives are to track major LEA (MLEA) rates over time among Medicare beneficiaries residing...

Agreement between Patient-reported Pain Medication Use and Electronic Medical Record Data in Surgical Amputation Patients.

Opioid misuse after surgery remains a public health crisis in the United States. Recent efforts have focused on tracking pain medication use in surgical populations. However, accurate interpretations of medication use remain quite challenging given inconsistent usage of different datasets. The purpose of this study was to investigate the agreement between electronic medical records (EMR) versus patient self-reported use of pain medications in a surgical amputation population. Patients undergoing major lower extremity amputation or amputation-related procedures were included in this study. Both self-reported and EMR data for pain medication intake were obtained for each patient at three time points (preoperatively, 4 months postoperatively, and 12 months postoperatively). Percentage agreement and the kappa statistic were calculated for both usage (yes/no) and dose categories. Forty-five patients were included in this study, resulting in 108 pairs of self-reported and EMR datasets. Substantial levels of agreement (>70% agreement, kappa >0.61) for opioid use was seen at preoperative and 12 months postoperative. However, agreement dropped at 4 months postoperatively. Anticonvulsant medication showed high levels, whereas acetaminophen showed lower levels of agreements at all time points. Either self-reported or EMR data may be used in research and clinical settings for preoperative or 12-month postoperative patients with little concern for discrepancies. However, at time points immediately following the expected end of acute surgical pain, self-reported data may be needed for more accurate medication reporting. With these findings in mind, usage of datasets should be driven by study objectives and the dataset's strength (eg, accuracy, ease, lack of bias).

Analysis of Lower Extremity Amputations from the SerbVasc Registry.

Peripheral arterial disease (PAD) and diabetes are the major causes of lower extremity amputations (LEAs) worldwide. Morbidity and mortality in patients with LEAs are high with an associated significant burden on the global health system. The aim of this article is to report the overall morbidity and mortality rates after major and minor LEAs from the Serbian Vascular Registry (SerbVasc), with an analysis of predictive factors that influenced adverse outcomes. SerbVasc was created in 2019 as a part of the Vascunet collaboration that is aiming to include all vascular procedures from 21 hospitals in Serbia. Prevalence of diabetes among patients with LEAs, previous revascularization procedures, the degree and the type of foot infection and tissue loss, and overall morbidity and mortality rates were analyzed, with a special reference to mortality predictors. In the period from January 2020 to December 2022, data on 702 patients with LEAs were extracted from the SerbVasc registry, mean age of 69.06±10.63 years. Major LEAs were performed in 59%, while minor LEAs in 41% of patients. Diabetes was seen in 65.1% of the patients, with 44% of them being on insulin therapy. Before LEA, only 20.3% of patients had previous peripheral revascularization. Soft tissue infection, irreversible acute ischemia, and Fontaine III and IV grade ischemia were the most common causes of above-the-knee amputations while diabetic foot was the most common cause of transphalangeal and toe amputations. The infection rate was 3.7%, the re-amputation rate was 5.7%, and the overall mortality rate was 6.9%, with intrahospital mortality in patients with above-the-knee amputation of 11.1%. The most significant intrahospital mortality predictors were age >65 years (p<0.001), chronic kidney disease (CKD) (p<0.001), ischemic heart disease (IHD) (p=0.001), previous myocardial revascularization (p=0.017), emergency type of admission (p<0.001), not using aspirin (p=0.041), using previous anticoagulation therapy (p=0.003), and postoperative complications (p<0.001). The main predictors of increased mortality after LEAs from the SerbVasc registry are age >65 years, CKD, IHD, previous myocardial revascularization, emergency type of admission, not using aspirin, using previous anticoagulation therapy, and postoperative complications. Taking into account high mortality rates after LEAs and a small proportion of previous peripheral revascularization, the work should be done on early diagnosis and timely treatment of PAD hopefully leading to decreased number of LEAs and overall mortality. Mortality after lower limb amputation from the SerbVasc register is high. A small number of previously revascularized patients is of particular clinical importance, bearing in mind that the main reasons for above-the-knee amputations were irreversible ischemia, Fontaine III and Fontaine IV grade ischemia. Lack of diagnostics procedures and late recognition of patients with PAD, led to subsequent threating limb ischemia and increased amputation rates. The work should be done on early diagnosis and timely treatment of PAD in Serbia, hopefully leading to an increased number of PAD procedures, decreased number of LEAs, and lower overall mortality.

Determinants of Prosthetic Referral and Functional Mobility Following Prosthesis Fitting for Vascular Patients after Major Lower Extremity Amputation

Determinants of Prosthetic Referral and Functional Mobility Following Prosthesis Fitting for Vascular Patients after Major Lower Extremity Amputation

Disparities and Trends in Major Lower Extremity Amputation Rates in Philadelphia Region from 2012 to 2021

Disparities and Trends in Major Lower Extremity Amputation Rates in Philadelphia Region from 2012 to 2021

The association of comorbid depression with mortality and amputation risk in patients with chronic limb-threatening ischemia

ObjectiveThere is increasing evidence that depression is a risk factor for worse outcomes in patients with peripheral artery disease. The association of depression in patients with chronic limb-threatening ischemia (CLTI) is not well described, nor is the impact of medical treatment for depression in this patient population. The objective of this study was to investigate the prevalence of depression in patients with CLTI, its association on major amputation and all-cause mortality, and whether medical antidepressant treatment is associated with improvement in these outcomes in patients with depression. MethodsA retrospective review of all adult patients (≥18 years old) diagnosed with CLTI from January 1, 2007, to December 31, 2018, at a single academic medical center was performed. Collected data included patient demographics, comorbidities, and diagnosis of depression within 6 months of initial CLTI diagnosis. We also collected data on use of antidepressant medications. Outcomes evaluated were need for major lower extremity amputation and all-cause mortality. Multivariable logistic regression models estimated the adjusted effects of comorbid depression and antidepressant medication use on major amputation and all-cause mortality. Kaplan-Meier survival curves illustrated the probabilities of survival and limb salvage over time, stratified by diagnosis of comorbid depression. Multivariable Cox proportional hazards models estimated the adjusted effects of comorbid depression on time to major amputation and all-cause mortality, and the adjusted effect of antidepressant treatment on time to all-cause mortality. ResultsA total of 2987 patients with CLTI were identified. Mean age was 68.6 years (standard deviation, 12.9 years); 56.5% were male, and 43.5% were female. Comorbid depression within 6 months of CLTI diagnosis was present in 7.1% of the cohort (212 patients). In multivariable analysis, comorbid depression was associated with a 68% increase in the odds of major amputation (adjusted odds ratio [aOR], 1.68; 95% confidence interval [CI], 1.19-2.37; P < .01), a 164% increase in the odds of all-cause mortality among patients not taking antidepressants (aOR, 2.64; 95% CI, 1.31-5.32; P = .03), and only a 6% increase in the odds of all-cause mortality among patients taking antidepressants (aOR, 1.06; 95% CI, 0.72-1.55; P = .99). The effect of comorbid depression on mortality varied significantly by whether or not the patient was taking an antidepressant medication (P = .02). ConclusionsComorbid depression in the patient population with CLTI is associated with a worse prognosis for major lower extremity amputation overall, and a worse prognosis for all-cause mortality among patients not taking an antidepressant. Furthermore, antidepressant treatment in the presence of comorbid depression in this patient population is associated with an improvement in the odds of all-cause mortality, illustrating the potential importance of medical management of depression.

Impact of Diabetic Foot Multidisciplinary Unit on Incidence of Lower-Extremity Amputations by Diabetic Foot.

One of the most devastating complications of diabetes is diabetes-related foot disease (DFD), which is a priority for public health systems. The 2016-2020 Catalonia Health Plan aimed to reduce the incidence of total and major lower-extremity amputations (LEAs) due to DFD by 10% in the population aged 45-74 years. The aim of the present study was to compare the incidence of LEA-DFD 5 years before and after the creation of the Diabetic Foot Multidisciplinary Unit at our Hospital. We prospectively collected all cases of LEA-DFD performed at Vall d'Hebron University Hospital from 1 January 2016 to 31 December 2020. Cases of LEA-DFD performed from 1 January 2011 to 31 December 2015 were retrospectively reviewed. The incidence of LEA-DFD between these periods was compared. A total of 457 LEAs due to DFD were performed in 316 patients. We observed a reduction of 27.9% [CI: 23.7-32.1%] in the incidence of total LEA in the 2016-2020 period in comparison with the period 2011-2016 (0.8 ± 0.1 vs. 1.1 ± 0.3 per 10.000 inhabitants/year, p < 0.001), as well as a reduction of 49.3% [CI: 44.6-53.9%] in the incidence of major LEA-DFD (0.15 ± 0.1 vs. 0.30 ± 0.1 per 10.000 inhabitants/year, p < 0.001). The implementation of a Diabetic Foot Multidisciplinary Unit resulted in a significant reduction in the rate of amputations due to DFD in the population with diabetes in North Barcelona.

Are current wound classifications valid for predicting prognosis in people treated for limb-threatening diabetic foot ulcers?

This study aims to investigate whether the current wound classifications were valid for the treatment prognosis of subjects treated for limb-threatening diabetic foot ulcers (LTDFU). A total of 1548 patients with LTDFU and infection were studied, with wounds recorded using the Wagner, Texas, PEDIS and WIfI classifications while major lower extremity amputations (LEAs) or in-hospital mortality incidences were defined as poor outcomes. Among them, 153 (9.9%) patients received major LEAs and 38 (2.5%) patients died. After adjustments, the Wagner classification and Texas stage as well as clinical factors such as comorbidity with major adverse cardiac events (MACE), being under dialysis and having serum levels of C-reactive protein (CRP) and albumin were independent factors for prognosis. For patients without dialysis, Wagner and Texas stage stood out independently for prognosis. For patients on dialysis, only levels of CRP (odds ratio [OR] = 2.2 in Wagner, OR = 2.0 in WIfI, OR = 2.2 in Texas, OR = 2.3 in PEDIS) and albumin (OR = 0.4 in four classifications) were valid predictors. The Wagner system and Texas stage were valid for predicting prognosis in treatment for LTDFUs, suggesting a role of vascular perfusion. MACE history, levels of CRP and albumin level should assist in prediction; more significantly, only levels of CRP and albumin appeared valid for those subjects undergoing dialysis.

Effectiveness of incisional negative pressure wound therapy after major lower extremity amputation: a randomised controlled trial.

The aim was to study the effect of incisional negative pressure wound therapy (iNPWT) in wound healing compared with standard sterile gauze dressings after major lower extremity amputation in patients with peripheral arterial disease (PAD). This prospective, randomised controlled trial included 50 patients undergoing major lower extremity amputations for PAD. Patients were randomised into iNPWT and standard dressing groups. The patency of blood vessels at the level of the stump was ensured with or without revascularisation. The primary outcome was wound-related complications such as surgical site infection (SSI), wound dehiscence, seroma/haematoma formation or the need for revision amputation. The secondary outcome was the time taken for the eligibility of prosthesis placement. It was found that only 12% of the patients in the iNPWT group had SSI compared with 36% in the standard dressing group (p = 0.047). Rates of wound dehiscence, seroma/haematoma formation and revision amputation were decreased in the iNPWT group but this was not statistically significant (p > 0.05). There was a significant reduction in the time taken for eligibility of prosthesis placement in the iNPWT group (5.12 ± 1.53 vs 6.8 ± 1.95 weeks, p = 0.002). iNPWT is effective in reducing the incidence of SSI and the time taken for rehabilitation in patients undergoing major lower limb amputation due to PAD.

Predictors of Ambulatory Status at 1 Year Following Major Lower Extremity Amputation

Nearly 60,000 major lower extremity amputations (AKA/BKA) are performed annually in the United States. We created a simple risk score for predicting ambulation at 1 year following AKA/BKA. We queried the Vascular Quality Initiative amputation database for patients who underwent above-knee (AKA) or below-knee (BKA) amputation (2013-2018). The primary endpoint was ambulation at 1 year either independently or with assistance. The cohort was divided into 80% derivation and 20% validation. Using the derivation set, a multivariable model identified preoperatively available independent predictors of 1 year ambulation and an integer-based risk-score was created. Scores were calculated to assign patients to risk groups-low, medium, or high chance of being ambulatory at 1 year. Internal validation was performed by applying the risk score to the validation set. Of 8725 AKA/BKA, 2055 met inclusion criteria-excluded: 2644 nonambulatory prior to amputation, 3753 missing 1-year follow-up ambulatory status. The majority-n=1366, 66% were BKAs. The indications were CLTI; 47%, ischemic tissue loss; 9%, ischemic rest pain; 35%, infection/neuropathic; 9%, acute limb ischemia. Ambulation at 1 year was higher for BKA than AKA: 67%, versus 50%, p < .0001. In the final prediction model, contralateral BKA/AKA was the strongest predictor of nonambulation. The score provided reasonable discrimination (C-statistic=0.65) and was well calibrated (Hosmer-Lemeshow p=.24). Sixty-two percent of patients who were ambulatory preoperatively remained ambulatory at 1 year. An integer-based risk score can stratify patients according to chance of ambulation at 1 year after major amputation and may be useful for preoperative patient counseling and selection.

Getting a Foothold on Diabetic Foot Disease-Outcomes of a Multidisciplinary Clinical Pathway for Inpatient Diabetic Foot Care: A 17-Year Institutional Review.

Diabetes foot disease (DFD) contributes to poor quality of life, clinical and economic burden. Multidisciplinary diabetes foot teams provide prompt access to specialist teams thereby improving limb salvage. We present a 17-year review of an inpatient multidisciplinary clinical care path (MCCP) for DFD in Singapore. This was a retrospective cohort study of patients admitted for DFD and enrolled in our MCCP to a 1700-bed university hospital from 2005 to 2021. There were 9279 patients admitted with DFD with a mean of 545 (±119) admissions per year. The mean age was 64 (±13.3) years, 61% were Chinese, 18% Malay and 17% Indian. There was a higher proportion of Malay (18%) and Indian (17%) patients compared to the country's ethnic composition. A third of the patients had end stage renal disease and prior contralateral minor amputation. There was a reduction in inpatient major lower extremity amputation (LEA) from 18.2% in 2005 to 5.4% in 2021 (odds ratio 0.26, 95% confidence interval 0.16-0.40, P < .001) which was the lowest since pathway inception. Mean time from admission to first surgical intervention was 2.8 days and mean time from decision for revascularization to procedure was 4.8 days. The major-to-minor amputation rate reduced from 1.09 in 2005 to 0.18 in 2021, reflecting diabetic limb salvage efforts. Mean and median length of stay (LOS) for patients in the pathway was 8.2 (±14.9) and 5 (IQR = 3) days, respectively. There was a gradual trend of increase in the mean LOS from 2005 to 2021. Inpatient mortality and readmission rate was stable at 1% and 11%. Since the institution of a MCCP, there was a significant improvement in major LEA rate. An inpatient multidisciplinary diabetic foot care path helped to improve care for patients with DFD.

#3938 THE ASSOCIATION BETWEEN HEMOGLOBIN A1C LEVEL AND COMPLICATIONS IN PATIENTS WITH DIABETES AND ADVANCED CHRONIC KIDNEY DISEASE

Abstract Background and Aims Although the global prevalence of advanced diabetic kidney disease is increasing, the optimum glycemic target remains uncertain. Specifically, data pertaining to the association of hemoglobin A1c (HbA1c) level with micro- and macrovascular outcomes in patients with advanced diabetic kidney disease remain inconclusive. We examined the association between HbA1c levels and complications in patients with diabetes and chronic kidney disease (CKD) stage 4 and 5. Method In a Danish nationwide registry-based retrospective cohort study, we included persons ≥18 years of age with diabetes, an estimated glomerular filtration rate (eGFR) &amp;lt;30 mL/min/1.73m2 and a concurrent measured HbA1c between 2010 and 2022. Complications were categorized as 1) major adverse cardiovascular events (MACE) defined as a composite endpoint of acute myocardial infarction, stroke, and all-cause mortality; 2) microvascular complications defined as a composite endpoint of diabetic retinopathy, major lower extremity amputation, and start of dialysis; 3) hospitalization with hypoglycemia. Multiple outcome-specific Cox regressions stratified by HbA1c levels were performed to calculate the 1-year risk of complications standardized to the distribution of risk factors of all patients in the sample. The analyses regarding the risk of hypoglycemia were further stratified according to insulin treatment at baseline. Results In total, 34,046 patients were included. The median age was 76.2 (IQR 69.1-82.7) years and 54.6% were men. The median eGFR and HbA1c level was 26.4 (IQR 21.9-28.5) mL/min/1.73m2 and 53 (IQR 46-63) mmol/mol, respectively. Figure 1 depicts the 1-year risks of MACE and microvascular complications stratified by HbA1c level. We found a U-shaped association between HbA1c level and MACE where patients with an HbA1c level between 45-50 mmol/mol had the lowest risk. The risk increased significantly with an HbA1c level below 45 mmol/mol or above 65 mmol/mol compared with 45-50 mmol/mol (P&amp;lt;0.001). The risk of microvascular complications was lowest at an HbA1c level between 35-40 mmol/mol. The risk increased significantly with increasing levels of HbA1c above 50 mmol/mol compared with 35-40 mmol/mol (P&amp;lt;0.05). The 1-year risks of hospitalization with hypoglycemia stratified according to HbA1c level and insulin treatment are illustrated in Figure 2. For both groups, the risk was lowest at an HbA1c level between 30-40 mmol/mol and increased with increasing HbA1c levels. Conclusion In patients with diabetes and CKD stage 4 and 5, HbA1c levels &amp;gt;65 mmol/mol and &amp;lt;45 mmol/mol were associated with an increased risk of MACE, whereas HbA1c levels &amp;gt;50 mmol/mol were associated with a higher risk of microvascular complications. Our findings suggest that appropriate glycemic control can reduce adverse outcomes in patients with advanced CKD without increasing the risk of hypoglycemia, but also suggest that intensive glycemic control (HbA1c &amp;lt;45 mmol/mol) might be associated with an increased risk of MACE.

The impact of diabetes on mortality rates after lower extremity amputation.

To assess the impact of diabetes, amputation level, sex and age on mortality rates after lower extremity amputation (LEA) in Belgium, and to assess temporal trends in one-year survival rates from 2009 to 2018. Nationwide data on individuals who underwent minor and major LEA from 2009 to 2018 were collected. Kaplan-Meier survival curves were constructed. A Cox regression model with time-varying coefficients was used to estimate the likelihood of mortality after LEA in individuals with or without diabetes. Matched amputation-free individuals with or without diabetes were used for comparison. Time trends were analysed. 41 304 amputations were performed: 13 247 major and 28 057 minor. Five-year mortality rates in individuals with diabetes were 52% and 69% after minor and major LEA, respectively (individuals without diabetes: 45% and 63%, respectively). In the first six postoperative months, no differences in mortality rates were found between individuals with or without diabetes. Later, hazard ratios (HRs) for mortality in individuals with diabetes (compared with no diabetes) after minor LEA ranged from 1.38 to 1.52, and after major LEA from 1.35 to 1.46 (all p≤0.005). Among individuals without LEA, HRs for mortality in diabetes (versus no diabetes) were systematically higher compared to the HRs for mortality in diabetes (versus no diabetes) after minor and major LEA. One-year survival rates did not change for individuals with diabetes. In the first six postoperative months, mortality rates after LEA were not different between individuals with or without diabetes; later, diabetes was significantly associated with increased mortality. However, as HRs for mortality were higher in amputation-free individuals, diabetes impacts mortality less in the minor and major amputation groups relative to the comparison group of individuals without LEA.

Community-wide feasibility of the Lower Extremity Amputation Protocol amongst vascular amputees

BackgroundThe Lower Extremity Amputation Protocol (LEAP) is a multidisciplinary enhanced recovery after surgery pathway for vascular amputees. The objective of this study was to examine feasibility and outcomes of community-wide implementation of LEAP. MethodsLEAP was implemented at three safety net hospitals for patients with peripheral artery disease or diabetes requiring major lower extremity amputation. Patients who underwent LEAP (LEAP) were matched 1:1 with retrospective controls (NOLEAP) on hospital location, need for initial guillotine amputation, and final amputation type (above- vs below-knee). Primary endpoint was postoperative hospital length of stay (PO-LOS). ResultsA total of 126 amputees (63 LEAP and 63 NOLEAP) were included with no difference between baseline demographics and co-morbidities between the groups. After matching, both groups had the same prevalence of amputation level (76% below-knee vs 24% above-knee). LEAP patients had shorter duration of postamputation bed rest (P = .003) and were more likely to receive limb protectors (100% vs 40%; P ≤ .001), prosthetic counseling (100% vs 14%; P ≤ .001), perioperative nerve blocks (75% vs 25%; P ≤ .001), and postoperative gabapentin (79% vs 50%; P ≤ .001). Compared with NOLEAP, LEAP patients were more likely to be discharged to an acute rehabilitation facility (70% vs 44%; P = .009) and less likely to be discharged to a skilled nursing facility (14% vs 35%; P = .009). The median PO-LOS for the overall cohort was 4 days. LEAP patients had a shorter median PO-LOS (3 [interquartile range, 2-5] vs 5 [interquartile range, 4-9] days; P < .001). On multivariable logistic regression, LEAP decreased the odds of a PO-LOS of ≥4 days by 77% (odds ratio, 0.23; 95% confidence interval, 0.09-0.63). Overall, LEAP patients were significantly less likely to have phantom limb pain (5% vs 21%; P = .02) and were more likely to receive a prosthesis (81% vs 40%; P ≤ .001). In a multivariable Cox proportional hazards model, LEAP was associated with an 84% reduction in time to receipt of prosthesis (hazard ratio, 0.16; 95% confidence interval, 0.085-0.303; P < .001). ConclusionsCommunity wide implementation of LEAP significantly improved outcomes for vascular amputees demonstrating that utilization of core ERAS principles in vascular patients leads to decreased PO-LOS and improved pain control. LEAP also affords this socioeconomically disadvantaged population a greater opportunity to receive a prosthesis and return to the community as a functional ambulator.

Evolution of amputee care

Life does not end after a major lower extremity amputation. With advances in surgical technique and in sophistication and capabilities of prosthetics, patients should be reasonably expected to return to most of their pre-amputation physical capabilities. This article highlights management and operative principles that will optimize patients' physical function and quality of life following a major lower extremity amputation.

The Sustained Impact of the COVID-19 Pandemic on Vascular Surgical Care Delivery

The coronavirus disease 2019 (COVID-19) pandemic necessitated postponement of vascular surgery procedures nationally. Whether procedure volumes have since recovered remains undefined. Therefore, we sought to quantify changes in procedure volumes and determine whether surgical volume has returned to its prepandemic baseline. We utilized the US Fee-for-Service Medicare 5% National Sample as part of the Department of Veterans Affairs-funded Disrupted Care National Project. We analyzed abdominal aortic aneurysm (AAA) repair for intact aneurysms, carotid endarterectomy (CEA), and major lower extremity amputation (LEA) from 2018 to 2021. Each quarter of 2020 and 2021 was compared to its corresponding prepandemic quarter in 2019. We then performed a subanalysis of these trends by sex, age, and race. We identified 15,921 procedures: 3278 AAA repair, 6399 CEA, and 6244 LEA (Table, Figure). The average percent change during the baseline period from 2018 to 2019 was −4.3% for AAA repair, −8.5% for CEA, and −2.6% for LEA. Compared to Q2 of 2019, Q2 of 2020 demonstrated that AAA repair procedures decreased by 47%, CEA by 40%, and LEA by 14%. While procedures initially rebounded in Q3 of 2020, volumes did not return to their prepandemic baseline, demonstrating a persistent volume reduction (−16% AAA, −22% CEA, and −11% LEA). Thereafter, procedure counts again declined in Q4 of 2021(–42% AAA, −54% CEA, and −41% LEA). Despite the perception that vascular surgical care was singularly disrupted at the outset of the pandemic, there has been a sustained reduction in vascular surgical volume since 2019. Not only have procedure volumes not returned to pre-pandemic baseline, but it also appears that there has been a cumulative incremental impact on overall procedure volume. The impact of these findings on long term population health remain uncertain and necessitate a better understanding of postpandemic care delivery.TableChanges in procedure counts during selected quarters of the pandemic as compared to the baseline prepandemic rateAverage annual percent change (2018-2019)Procedure count Q2 2019Procedure count Q2 2020Percent changeProcedure count Q3 2019Procedure count Q3 2020Percent changeProcedure count Q4 2019Procedure count Q4 2021Percent changeIntact AAA repair−4.3%258137−46.9%221185−16.3%241141−41.5%CEA−8.5%474287−39.5%462360−22.1%423193−54.4%Major LEA−2.6%441381−13.6%423378−10.6%402236−41.3%AAA, Abdominal aortic aneurysm; CEA, carotid endarterectomy; LEA, lower extremity amputation.The baseline pre-pandemic count is defined as the corresponding quarter in 2019. Open table in a new tab