Amputation Rate Research Articles

Evaluating the Safety of Sodium-Glucose Cotransporter-2 Inhibitors in a Nationwide Veterans Health Administration Observational Cohort Study

Sodium-glucose cotransporter-2 inhibitors (SGLT-2is) are indicated in patients with or without type 2 diabetes mellitus atherosclerotic cardiovascular disease, chronic kidney disease, or heart failure. Postmarket surveillance data have identified many safety signals which warrants further investigation. We aimed to compare the safety of SGLT-2i and glucagon-like peptide-1 receptor agonists (GLP-1RA). Using the Veterans Health Administration nationwide database, patients with type 2 diabetes mellitus who were newly initiated on a SGLT-2i or GLP-1RA between April 1, 2013 and September 1, 2020 were identified. The primary outcome was the incidence of any amputation, below-knee amputation (BKA), all clinical fractures, hip fracture, Fournier gangrene, acute pancreatitis, diabetic ketoacidosis (DKA), serious urinary tract infections (UTIs), and venous thromboembolism (VTE). All outcomes were compared between the treatment groups. Cox proportional hazard models were used to estimate adjusted hazard ratios (aHRs) for the comparative analysis. A total of 70,694 propensity-matched new users of SGLT-2i and GLP-1RA were identified. The use of SGLT-2 inhibitors, compared with GLP-1RA, was not associated with an increased rate of any amputation (aHR 1.02, 95% confidence interval [CI] 0.82 to 1.27), BKA (aHR 1.05, 95% CI 0.84 to 1.32), all clinical fractures (aHR 0.94, 95% CI 0.86 to 1.03), hip fractures (aHR 0.82, 95% CI 0.50 to 1.32), DKA (aHR 1.66, 95% CI 0.97 to 2.85), VTE (aHR 1.02, 95% CI 0.80 to 1.30), acute pancreatitis (aHR 1.02, 95% CI 0.80 to 1.30), and Fournier gangrene (aHR 0.92 95% CI 0.61 to 1.38). Lower rates of serious UTIs were observed in the SGLT-2i group than in the GLP-1RA group (aHR 0.74, 95% CI 0.64 to 0.84). This real-world study found that SGLT-2i use compared with GLP-1RA did not increase the rate of amputation, BKA, clinical fractures, hip fracture, Fournier gangrene, acute pancreatitis, DKA, serious UTIs, and VTE in veteran patients.

Evaluating the Efficacy of Hyperbaric Oxygen Therapy in Digital Frostbite

Frostbite is a limb threatening, cold-induced tissue injury most commonly affecting the extremities. Hyperbaric oxygen therapy (HBOT) is a proposed adjunctive treatment for this condition, which acts by increasing cellular oxygen availability in damaged tissues. Currently, there is a lack of data regarding the effectiveness of HBOT. Therefore, the purpose of this study is to further the research as one of the largest retrospective comparative cohort studies to date. We evaluated the efficacy of HBOT in the treatment of digital frostbite compared to a non-HBOT-treated group, with a focus on amputation outcomes between each group. A multicenter retrospective cohort study was performed from January 2016 to August 2021 observing patients seen for frostbite. Amputation characteristics and encounter outcomes of patients treated with HBOT were compared to those in patients treated without HBOT. A one-to-one matching of HBOT-treated and non-HBOT-treated patients was also performed, followed by chi-square and Fisher's exact test statistical analysis. The results of the study found a low overall amputation rate of 5.2% across both cohorts. Comparison between groups identified no statistical difference between HBOT and non-HBOT groups regarding amputation characteristics through matched cohort analysis. However, an increased length of hospital stay in patients treated with HBOT (22.2 days) compared to the non-HBOT group (6.39 days) was identified. Based on this study, recommendations for future HBOT studies should evaluate the efficacy of HBOT for more severe cases of frostbite, with additional consideration for cost analysis studies.

Popliteal Artery Injuries: Incidence, Clinical Patterns and Outcomes (A Single Center Study in Yemen)

Background: Below the inguinal ligament, popliteal artery injuries are the second most frequent arterial injuries in the world. In order to share our experience with complex traumatic popliteal vascular injuries at Al-Thawra Modern General Hospital in Sana’a City- Yemen, we focus on the incidence, initial presentation, surgical management, and outcomes of popliteal artery injuries. Patients and Methods: Over the 3-year period from 1 January 2020 to 31 December 2022, all patients with popliteal artery injuries regardless of their other synchronized injuries were included. By contrast, patients who are managed as popliteal artery injuries by a military care giver at battle field were excluded from our analysis. In the diagnosis of popliteal artery injury, we relied on the physical examination. The main outcome was either patients get complete recovery, partial function loss of the limb, or end with amputation. Results: During study period, an overall incidence of popliteal artery injuries was 0.9%. Of 26 patients with popliteal artery injuries, 25 (96.2%) patients were men, and more than half of our patients (53.8%) were in the age group ≤ 25 years, with an overall mean of age 24.5 ± 5.6 years. The distribution of patients in groups of time delays in treatment of ≤ 6 hours, 6-10 hours and more than 10 hours was 9 (34.6%), 12 (46.2%) and 5 (19.2%) respectively. The mechanisms of injury were penetrating and blunt in 24 (92.3%) and 2 (7.7%) patients respectively. Patients who received a fasciotomy was 25 (96.2%). In our cohort of patients, incidence of amputation was 11.5%, while partial function loss rate was 27%. Conclusion and Recommendations: In our cohort of patients, incidence of popliteal artery injuries was high. Despite technical improvements in management of popliteal artery injury, a high amputation rate is observed in our study. The need for early diagnosis and early referral to definitive care must be emphasized. One of the most important ways to lower the risk of amputation is to shortening the duration of ischemia.

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.

Contemporary Treatment and Outcome of Patients with Ischaemic Lower Limb Amputation: A Focus on Sex Differences

Chronic limb threatening ischaemia (CLTI) has a devastating prognosis with high rates of lower limb amputation (LLA) and deaths. This is an illustration of contemporary management and the long term fate of patients after ischaemic LLA, particularly with respect to sex, using real world data. This was a multisectoral cross sectional and longitudinal analysis of health claims data from the largest German health insurance database (AOK). Data of 39 796 propensity score matched patients hospitalised for ischaemic LLA between 2010 and 2018 were analysed for cardiovascular comorbidities, treatment, and for subsequent cardiovascular and limb events, with a distinct focus on sex. Matching was performed, to ensure that the rate of major amputations and the age distribution were equal in both groups (in both sexes). An observation period of two years before index and a follow up (FU) period until 2019 were included. Before index amputation, 68% of patients had received any kind of peripheral revascularisation. The use of statins (37.0% vs. 42.6%) and antithrombotic substances (54.9% vs. 61.8%) was lower in women than in men (p < .001). During two year FU, cardiovascular and limb events occurred among women and men as follows: limb re-amputation (26.7% vs. 31.2%), myocardial infarction (10.9% vs. 14.5%), stroke (20.8% vs. 20.7%), and death from any cause (51.0% vs. 53.3%, p < .001 except for stroke). After adjustment for cardiovascular comorbidities and vascular procedures, female sex was associated with a higher probability of death (HR 1.04, 95% CI 1.04 - 1.04). Patients undergoing ischaemic LLA still have a poor prognosis marked by high rates of recurrent cardiovascular and limb events resulting in a > 50% mortality rate within two years. The continuous lack of guideline recommended therapies, particularly in women, may be associated with the persisting poor outcome, necessitating urgent further investigation.

Heparin-Bonded Expanded Polytetrafluoroethylene Is a Solution for Infrapopliteal Revascularization in the Absence of an Adequate Autologous Vein Graft

To analyze the outcomes of heparin-bonded expanded polytetrafluoroethylene (HePTFE) graft as an alternative conduit in infrapopliteal revascularization of chronic limb-threatening ischemia (CLTI) in the absence of an autologous vein conduit. A single-center retrospective analysis of patients with CLTI submitted to infrapopliteal bypasses with autologous vein graft (VEIN group) or HePTFE graft (HePTFE group) was implemented. Primary end points were freedom from CLTI at 12months and recurrence of CLTI at 3years. Secondary end points included freedom from major amputation, amputation-free survival (AFS), survival, and primary (PP) and secondary patency (SP) rates at 3years of follow-up. A total of 348 limbs submitted to infrapopliteal bypasses, 214 with venous graft and 134 with HePTFE graft, were followed-up for a median of 25months. Most patients of the HePTFE group were male (69%), with a median age of 76years (interquartile range [IQR] 15). Fifty-nine percent of the limbs of the HePTFE group had Wound grade ≥2, being 46% of them infected. Eighty-eight percent were GLASS stage III. Freedom from CLTI was not significantly different between HePTFE and VEIN groups (75% vs. 84%, adjusted hazard ratio [aHR] 0.88, confidence interval [CI] 0.66-1.18, P=0.401). Recurrence of CLTI was higher in the HePTFE group (42% vs.18% at 3years; aHR 2.82, CI 1.59-5.00, P<0.001). The VEIN group achieved higher rates of freedom from major amputation (87% vs.69% at 3years; aHR 2.21, CI 1.31-3.75, P=0.003) and AFS (59% vs. 37% at 3years; aHR 1.39, CI 1.02-1.88, P=0.036), but no significance in survival (aHR 1.10, CI 0.72-1.66, P=0.667). Patency rates were inferior in the HePTFE group, with 2-year PP and SP rates of 52% vs. 74%, and 76% vs. 90%, respectively (PP: aHR 1.70, CI 1.11-2.59, P=0.014; SP: aHR 2.51, CI 1.42-4.42, P=0.001). Infrapopliteal bypass with autologous vein graft is the gold standard to treat CLTI limbs. HePTFE graft should be regarded as an alternative for complex infrapopliteal revascularization when lacking an autologous vein conduct.

Efficacy of telemedicine applications in patients with diabetic foot ulcers: A focus on mortality and major amputation rates.

Amputations related to diabetic foot ulcers (DFU) are associated with high morbidity and mortality rates. Glycaemic control and close follow-up protocols are essential to prevent such ulcers. Coronavirus disease (COVID) related restrictions and regulations might have a negative impact on patients who are with DFU or candidates for DFU. We retrospectively analysed 126 cases that had DFU underwent amputation surgery. Comparative analyses were done between cases that were admitted before COVID restrictions (Group A) and cases admitted after COVID restrictions (Group B). Two groups were homogenic demographically. There was no significant difference between groups in terms of mortality (p = 0.239) and amputation rates (p = 0.461). The number of emergent cases in the pandemic period doubled the number in pre-pandemic period even though this finding was not statistically significant (p = 0.112). Fastly adapted consulting practice and follow-up protocols to compensate for the problems created by COVID-related regulations seem to be effective in terms of mortality and amputation rates.

511-P: Is It Reasonable to Treat Infected Diabetic Foot Ulcers by Autologous Cell Therapy in Patients with Severe Ischemia?

Aim: Autologous cell therapy (ACT) using bone marrow-derived mononuclear cells is an alternative treatment approach for patients no-option chronic limb-threatening ischemia (NO-CLTI). Diabetic foot infection (DFI) could negatively influence healing and amputation rates in patients with NO-CLTI. The aim of our study was to analyze the impact of DFI on the clinical outcomes of cell therapy in diabetic patients with NO-CLTI. Methods: One-hundred-forty-nine ACT applications was performed in 124 patients with NO-CLTI who were treated in our foot clinic over 15 years were included in the study. ACT applications were divided in 2 groups - DFI group with the presence of clinical signs of infection (n=46) and non-DFI group (n=103). Both groups were compared in baseline values and the changes in transcutaneous oxygen pressure (TcPO2) were evaluated after 6 months. Major amputation, amputation-free-survival (AFS) and ulcer healing were assessed during the whole follow-up after ACT (3 months to 14.3 years). Results: Median AFS in the non-DFI group was 4.6 years CI95=(3.7, 6.3), significantly higher compared to 1.4 years CI95=(0.5, 3.0) in the DFI group. Ulcer healing was significantly better in the non-DFI group with median time to heal 0.9 years CI95=(0.7, 1.1) compared to the DFI group where less than 40% of ulcers healed and lower bound of mean time to heal CI95=6.6 years. TcPO2 in DFI and no-DFI groups was without a significant difference at baseline. At 6 months it increased by 21.7 mmHg CI95=(18.0, 25.3) in the non-DFI group and by 29.8 mmHg CI95=(22.5, 37.2) in the DFI group. The difference between groups was significant (p=0.032). Conclusions: Our study showed that patients with NO-CLTI and baseline presence of DFI treated by ACT had significantly lower AFS and significantly worse ulcer healing. Therefore, the indication of ACT in patients with clinical signs of infection should be carefully considered. Disclosure M.Dubsky: None. J.Husáková: None. V.Fejfarova: None. K.Sutoris: None. D.Sojáková: None. R.Jarošíková: None. M.Kahle: None. Funding National Institute for Research of Metabolic and Cardiovascular Diseases (EXCELES LX22NPO5104); European Union; Next Generation EU; MZO (00023001)

The completeness of the left atrial appendage amputation during routine cardiac surgery

BackgroundLeft atrial appendage (LAA) is the origin of most heart thrombi which can lead to stroke or other cerebrovascular event in patients with non-valvular atrial fibrillation (AF). This study aimed to prove safety and low complication rate of surgical LAA amputation using cut and sew technique with control of its effectiveness.Methods303 patients who have undergone selective LAA amputation were enrolled in the study in a period from 10/17 to 08/20. The LAA amputation was performed concomitant to routine cardiac surgery on cardiopulmonary bypass with cardiac arrest with or without previous history of AF. The operative and clinical data were evaluated. Extent of LAA amputation was examined intraoperatively by transoesophageal echocardiography (TEE). Six months in follow up, the patients were controlled regarding clinical status and episodes of strokes.ResultsAverage age of study population was 69.9 ± 19.2 and 81.9% of patients were male. In only three patients was residual stump after LAA amputation larger than 1 cm with average stump size 0.28 ± 0.34 cm. 3 patients (1%) developed postoperative bleeding. Postoperatively 77 (25.4%) patients developed postoperative AF (POAF), of which 29 (9.6%) still had AF at discharge. On 6 months follow up only 5 patients had NYHA class III and 1 NYHA class IV. Seven patients reported with leg oedema and no patient experienced any cerebrovascular event in early postoperative follow up.ConclusionLAA amputation can be performed safely and completely leaving minimal to no LAA residual stump.

1000-P: The Economic Impact of Reducing Hospitalizations and Amputations in Patients with Diabetic Foot Ulcers

The purpose of this real-word evidence (RWE) cohort study was to evaluate whether utilization of Cyclical Pressurized Topical Oxygen (TWO2) therapy had any impact on the incidence of Diabetic Foot Ulcer related hospitalizations and amputations over a 12-month period in patients with hard to heal Diabetic foot Ulcers (DFU). An IRB approved retrospective review of deidentified DFU patient medical records was conducted at 2 US Veterans Affairs Medical Centers in Illinois and Virginia, which included demographic information on wound characteristics, clinical characteristics, neuropathy, cardiovascular disease (CVD), peripheral vascular disease (PVD), pain levels and kidney disease etc. Within the unmatched cohorts of the 202 DFU patients (91 TWO2, 111 NO TWO2)there was an 88% reduction in hospitalizations and a 71% reduction in amputations over a 12-month period for the patients treated with TWO2 therapy compared to those that did not receive TWO2 therapy. Propensity score matching was conducted showing similar outcomes and a regression analysis as preformed along with a budget impact model which demonstrated significant cost saving to the payor system. This large RWE study demonstrates the TWO2 therapy positively impacts patients quality of life and the costs associated with treating their DFU by forcing them into remission, resulting in significantly reduced rates of hospitalizations, amputations and cost outlay. Disclosure M.G.Garoufalis: Consultant; Uluru, Employee; AOT Inc., Speaker's Bureau; 3M/KCI, Horizon Therapeutics plc.

523-P: Identifying Risk Factors Associated with Diabetic Foot Wounds Outcomes within a Safety-Net Hospital System

Dallas county has a high prevalence of diabetes and increasing rates of diabetic foot wound related lower extremity amputations in the past few years. The healthcare spending associated with diabetic foot wounds and its complications is significant, with an average cost of hospitalization for lower extremity amputation of $91,000 at Parkland Health. To better understand the risk factors for developing diabetic foot wounds and its complications, we performed an electronic medical record review of patients with diabetic foot wounds who had a visit at the Parkland Diabetes Clinic between 2019-2022. We identified 78 patients (average age 51 years, 81% male, 68% Hispanic, 21% Black, 10% Caucasian, 68% receiving charity care) with type 2 diabetes and diabetic foot wounds. The average diabetes duration was 13 years, and the average A1c was 11.1% at diagnosis and improved to 8.5% within 3-6 months. The wounds completely healed in 42% (33/78) of the patients by 4 months, with an average time to healing of 72 days. Patients with healed wounds had lower average final A1c (8.3 vs 8.7%), shorter duration of diabetes (12 vs 14 years), and lower rate of peripheral vascular disease (52 vs 60%) compared to those with non-healed wounds. In conclusion, diabetic foot wounds were particularly prevalent among uninsured male Hispanic population within our safety-net health system. Better glycemic control and earlier detection of diabetes may lead to improved diabetic foot wound outcomes. Identifying these risk factors will help us better tailor educational and clinical interventions to prevent the development of diabetic foot wounds and improve clinical outcomes for patients with diabetic foot wounds. Disclosure F.Gunawan: None. B.Johnny: None. U.Gunasekaran: None.

Health Disparities in Peripheral Artery Disease: A Scientific Statement From the American Heart Association.

Peripheral artery disease (PAD) affects 200 million individuals worldwide. In the United States, certain demographic groups experience a disproportionately higher prevalence and clinical effect of PAD. The social and clinical effect of PAD includes higher rates of individual disability, depression, minor and major limb amputation along with cardiovascular and cerebrovascular events. The reasons behind the inequitable burden of PAD and inequitable delivery of care are both multifactorial and complex in nature, including systemic and structural inequity that exists within our society. Herein, we present an overview statement of the myriad variables that contribute to PAD disparities and conclude with a summary of potential novel solutions.

Modern approaches in the treatment of occlusive restenosis of the arteries of the lower extremities. Case report

Chronic lower limb ischemia is becoming increasingly common among patients worldwide. This is a comorbid condition, which is accompanied by chronic pain, trophic ulcers and gangrene, as well as a decrease in the quality of life. Despite the chronic nature of ischemia, the absence of treatment is accompanied by a high rate of limb amputation and mortality. It has been proven that in patients with peripheral arterial disease of the lower extremities, the risk of cardiovascular events and mortality increases. The publication proposes to consider the tactics of minimally invasive arterial revascularization in a patient with occlusive restenosis of the right superficial femoral artery. The correct choice of minimally invasive surgical treatment in combination with a complex of both non-drug (walking) and drug methods made it possible to restore viability and preserve the lower limb without unfavorable consequences for the patient’s health.

#3584 COMPLIANCE OF DIABETIC MONITORING IN PATIENTS WITH END-STAGE RENAL DISEASE ON MAINTENANCE HAEMODIALYSIS

Abstract Background and Aims Diabetic nephropathy is a major cause of end-stage kidney disease (ESKD) in the UK, accounting for nearly 30% of patients requiring dialysis and in some units over 40% of the people on dialysis have diabetes. The national reviewing and benchmarking committee (GIRFT NHS) had highlighted the disjointed and variable care received by these patients, with increasing risk of complications including blindness, foot ulcers and amputations from suboptimal care. Increased monitoring is shown to be cost-effective and co-ordination of a multi-disciplinary team focus can reduce complications especially lower limb amputation rates. Hence, we aimed to review the quality of care on our setting and compare it to national recommendations. Method We performed a cross-sectional review on patients with diabetes on haemodialysis in the satellite unit at a district general hospital to assess compliance with the Joint British Diabetes Societies (JBDS) and the UK Kidney Association (UKKA) recommendations on management of adults with diabetes. Subsequently we introduced monitoring protocols for the relevant key areas of diabetes monitoring (pre and post-dialysis glucose checks, HbA1c checks, check boxes for once weekly feet inspections, criteria for inpatient podiatry review), highlighted potential complications including hypoglycaemia, re-emphasised the importance of adequate documentation to allied healthcare teams, and updated the haemodialysis monitoring sheets. We worked with the unit manager to highlight the rationale for monitoring and provided brief education on complications to the team, and over repeated visits, gained the confidence and support of staff for the changes suggested despite an increased workload. Results We reviewed data from January to April 2021 followed by re-evaluation 12 months later after implementation of changes. Data for 25 patients were reviewed and re-assessed after a year. 7 patients passed away during this period. Initial review recognised the lack of awareness of good practice management of diabetic patients in the haemodialysis unit. Most patients have type 2 diabetes which carries a higher risk of ESKD. After a year of change in protocols there were significant improvements in monitoring parameters, with greatest improvements seen in glucose monitoring and routine feet inspections. Conclusion The review was based on care standards that included diabetes parameters as part of the recommended national care processes, and individualised treatment approach. The aims included were performing annual reviews, adequate glucose monitoring and rational glycaemic targets, and earlier targeted involvement of the diabetes specialist team. There was improvement in most of the monitoring parameters and clearer documentations from allied healthcare teams. Implementation of recommendations was initially challenging due to the COVID-19 pandemic and staff workload on the unit however with persistence we were able to obtain co-operation from the team. As expected, patients on insulin/sulphonylureas (SUs) had proper blood glucose monitoring methods. Most were on insulin, and the remaining were on SU and DPP-IV inhibitor, and those with HbA1c &amp;lt;58 mmol/mol declined. One-third of these patients used flash glucose monitoring and with increasing recognition and recommendation by the NHS hopefully more patients will benefit from this. This audit showed that simple interventions such as staff engagement and education can improve care and monitoring of patients in this population. With recovery of service provisions, more interventions can be put in place. Following this, we can reaudit amputation rates and gather patient feedback, plan interventions with the community team, and encourage involvement from general practitioners and their trainees to deliver better care to these patients. Hence, we emphasise the importance of clear protocols for the management and monitoring of each patient with diabetes mellitus in haemodialysis units to ensure care standards are met.

#4880 SUCCESSFUL LIMB SALVAGE IN A CHALLENGING PATIENT ON DIALYSIS BY IMPLANTATION OF AUTOLOGOUS PERIPHERAL BLOOD MONONUCLEAR CELLS: A CASE REPORT

Abstract Background and Aims Peripheral arterial disease (PAD) is an extremely common condition in patients with End-Stage Renal Disease (ESRD) on dialysis. Concomitant comorbidity such as diabetes may be associated with complex vascular dysfunction, and ESRD itself is a recognized risk factor for PAD leading to non healing ulcers and lower limb amputation, which occurs in a high rate of patients [1]. Despite improvement in endovascular techniques for lower extremity revascularization, the incidence of limb salvage among dialysis patients remains poor. Furthermore, lower extremity amputation in these patients is associated with higher mortality rates [2], in addition to important social and economic implications. In this Case Report, an emergent therapy approach was applied aiming to limb salvage in a 74 years old female patient on hemodialysis suffering from lower extremity critical ischemia in diabetic foot infection, otherwise candidate for major amputation, after ineffective angioplasty and Negative Pressure Wound Therapy (NPWT). Method After surgical debridement of the ischemic lesion, an innovative therapeutic approach [3] was performed. It consisted in implantation, in the perilesional area of the affected lower limb, of a concentrate of autologous peripheral blood mononuclear cells (PBMNC) taken from 120 ml of peripheral blood of the patient, by using a selective filtration separation system. This procedure was managed in the operating room and was repeated three times at intervals of 15 days from each other. Since concomitant osteomyelitis occurs in the ischemical diabetic foot under treatment, it was managed with a 2-dose regimen of weekly Dalbavancin, reaching infection control. The patient was followed twice a week for 7 months for regular medications. Results After the treatment approach, the granulation tissue improved gradually, obtaining complete surgical wound healing. Since toes gangrene occurs, amputation of the toes was necessary, but limb rescue was successfully reached. Conclusion The autologous implantation of PBMNC resulted in limb salvage in this patient on dialysis affected by critical peripheral arterial disease in diabetic foot. This approach has not been described in literature among patients on dialysis, despite the higher mortality rate associated with lower limb amputation in these patients. It seems to be a very promising therapy, with the potential to modify the natural history of no-options critical limb with diabetes complications, in terms of major amputation and overall survival rates. After thorough validation, the reported management could be considered for similar cases.

Performance of the BioIntegral Bovine Pericardial Graft in Vascular Infections: VASCular No-REact Graft Against INfection Study

Vascular graft and endograft infections (VGEI) and native vessel infections (NVI) remain considerable challenges in vascular surgery, leading to high mortality and morbidity rates. Although in situ reconstruction is the preferred treatment, the material of choice is still a source of debate. Autologous veins are considered the first choice; however, xenografts may be an acceptable alternative. The performance of a biomodified bovine pericardial graft is assessed when implemented in an infected vascular area. This is a prospective multicenter cohort study. Patients who underwent reconstruction for VGEI or NVI with a biomodified bovine pericardial bifurcated or straight tube graft were included from December 2017 until June 2021. The primary outcome measure was reinfection at mid-term follow-up. Secondary outcome measures included mortality, patency, and amputation rate. Thirty-four patients with vascular infections were included, of which 23 (68%) had an infected Dacron prosthesis after primary open repair and 8 (24%) had an infected endovascular graft. The remaining 3 (9%) had infected native vessels. At secondary repair, 3 (7%) patients had an in situ aortic tube reconstruction, 29 (66%) had an aortic bifurcated reconstruction, and 2 (5%) had an iliac-femoral reconstruction. At 1-year follow-up after the BioIntegral bovine pericardial graft reconstruction, the reinfection rate was 9%. The 1-year infection-related and procedure-related mortality rate was 16%. The occlusion rate was 6% and in total 3 patients underwent a lower limb amputation during the 1-year follow-up period. In situ reconstruction as treatment of (endo)graft and native vessel infections remains a challenge and reinfection looms as a potential consequence. In cases where time is of essence or when autologous venous repair is not feasible, a swift available solution is needed. The BioIntegral biomodified bovine pericardial graft may be an option as it shows reasonable results in terms of reinfection, in aortic tube and bifurcated grafts.

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

Background and aimsLower 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. MethodsIn 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. ResultsOf 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). ConclusionsFemale 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.

Spectrum of Acute Limb Ischemia and Management – A Single-center Study in Northern India

Background: Acute limb ischemia (ALI) can be defined as sudden deterioration in limb perfusion, often producing new or worsening symptomatology and usually threatening limb viability. The incidence of ALI is approximately 1.5 cases per 10,000 persons per year. Objective: The main objective of the study is to assess the spectrum of ALI and effective management options in a tertiary care center. Methodology: This was a retrospective and prospective observational study. All patients admitted in tertiary care center with ALI were included in this study. The medical records of patients admitted since last three years were collected retrospectively and the data of patients with ALI getting admitted during next one year was collected simultaneously. Patients who were included prospectively were followed for at least one month. Results: In the study period, we received 136 patients with 138 ALI (ALI presenting with 14 days = 95, ACLI = 17, ALI with delayed presentation = 26). Average age of patients was 47.4 years. 21 to 40 years age group made the largest cohort of 56 patients. 10.79% of the lower limb ischemia were female (15 out of 136). Among these categories, the outcomes depend upon the time of presentation (earlier presentation has the better outcomes in terms of limb salvage). The delayed presentation of ALI has poorer outcome of amputation whereas mortality rates are higher in ALI presenting early. Patency in ALI is better due to embolus. Outcome of ALI due to embolus are best followed by acute thromboembolic occlusion without pre-existing CLI. The worst outcomes in amputation are for ACLI when they present late. Etiology wise Cardio embolic group comprised as the commonest cause; High Altitude Thrombosis also is very significant in our setting. Class II B ischemia which is most surgically amenable, and the amputation rate is 20%. Conclusion: In our study, outcome of various modalities of management of ALI has been evaluated. Our study provided data which could be accessed to define the outcome and most amenable to any useful intervention affecting outcome in patients of limb ischemia. Revascularization in ALI is aimed not only to prevent amputation but also to limit the level of amputation which is a forgotten aspect of salvage procedure in lower extremity.

Correlation analysis between foot deformity and diabetic foot with radiographic measurement.

Foot deformity is a risk factor for diabetic foot ulcer. This study was aimed to investigate the relationship between hallux valgus (HV) and diabetic foot through the radiographic measurement. The patients with diabetic foot hospitalizing in the Department of Endocrinology, the First Affiliated Hospital of Chongqing Medical University from September 2016 to June 2020 were selected. Then the foot plain X-ray radiographs were completed, and the size of HV angle (HVA) was measured. Their clinical data were collected, and the ulcer recurrence rate, amputation rate and mortality rate of the patients were followed up. A total of 370 patients were included. According to HVA, patients were divided into non-HV group (HVA<15°), and mild (15°≤HVA ≤ 20°), moderate (20°<HVA ≤ 40°) and severe (HVA>40°) HV groups. The age, height, BMI, smoking history and glycosylated hemoglobin level among the non-HVA, mild, moderate, and severe HV group (P<0.05), while smoking history, HbA1c, eGFR and autonomic neuropathy were significantly lower in HV group than those in non-HV group (P<0.05). The ulcer area in patients with moderate HV was larger than that in non-HV patients, and the severity of infection in patients with severe HV was significantly higher than that the other three groups (P<0.05). The occurrence of HV is not only related to age and BMI, but also to the creatinine and eGFR level, autonomic neuropathy, lower limb arteriosclerosis occlusion, coronary heart disease and hypertension. Therefore, more attention should be paid to renal function screening, neuropathy screening and evaluation of lower extremity vascular lesions in patients with diabetes, especially those with moderate or higher HV.

Trends of Concomitant Diabetes and Peripheral Artery Disease and Lower Extremity Amputation in US Medicare Patients, 2007 to 2019.

Previous studies demonstrate geographic and racial/ethnic variation in diagnosis and complications of diabetes and peripheral artery disease (PAD). However, recent trends for patients diagnosed with both PAD and diabetes are lacking. We assessed the period prevalence of concurrent diabetes and PAD across the United States from 2007 to 2019 and regional and racial/ethnic variation in amputations among Medicare patients. Using Medicare claims from 2007 to 2019, we identified patients with both diabetes and PAD. We calculated period prevalence of concomitant diabetes and PAD and incident cases of diabetes and PAD for every year. Patients were followed to identify amputations, and results were stratified by race/ethnicity and hospital referral region. 9 410 785 patients with diabetes and PAD were identified (mean age, 72.8 [SD, 10.94] years; 58.6% women, 74.7% White, 13.2% Black, 7.3% Hispanic, 2.8% Asian/API, and 0.6% Native American). Period prevalence of diabetes and PAD was 23 per 1000 beneficiaries. We observed a 33% relative decrease in annual new diagnoses throughout the study. All racial/ethnic groups experienced a similar decline in new diagnoses. Black and Hispanic patients had on average a 50% greater rate of disease compared with White patients. One- and 5-year amputation rates remained stable at ≈1.5% and 3%, respectively. Native American, Black, and Hispanic patients were at greater risk of amputation compared with White patients at 1- and 5-year time points (5-year rate ratio range, 1.22-3.17). Across US regions, we observed differential amputation rates, with an inverse relationship between the prevalence of concomitant diabetes and PAD and overall amputation rates. Significant regional and racial/ethnic variation exists in the incidence of concomitant diabetes and PAD among Medicare patients. Black patients in areas with the lowest rates of PAD and diabetes are at disproportionally higher risk for amputation. Furthermore, areas with higher prevalence of PAD and diabetes have the lowest rates of amputation.