High Amputation Rate Research Articles

Optimization and Validation of an FTIR-based, All-in-one System for Viable MDR Bacteria Detection in Combat-related Wound Infection.

The U.S. Military members experiencing combat-related injuries have a higher chance of developing infections by multidrug-resistant (MDR) bacteria at admission to military hospitals. MDR wound infections result in higher amputation rates and greater risks for subsequent or chronic infections that require readmission or extended stay in the hospital. Currently, there is no FDA-clear, deployable early diagnostic system for suitable field use.We are reporting our efforts to improve a previously developed Rapid Label-free Pathogen Identification (RAPID) system to detect viable MDR bacteria in wound infections and perform antibiotic susceptibility testing (AST). Specifically, we added multiplex and automation capability and significantly simplified the sample preparation process. A functional prototype of the improved system was built, and its performance was validated using a variety of lab-prepared spiked samples and real-world samples. To access the baseline performance of the improved RAPID system in detecting bacteria presence, we selected 17 isolates, most of them from blood or wound infections, and prepared mono-strain spiked samples at 104 to 106 cfu/mL concentration. These samples were processed and analyzed by the RAPID system. To demonstrate the AST capability of the system, we selected 6 strains against 6 different antibiotics and compared the results from the system with the ones from the gold standard method.To validate the system's performance with real-world samples, we first investigated its performance on 3 swab samples from epicutaneous methicillin-resistant Staphylococcus aureus-exposed mouse model. The AST results from our system were compared with the ones from the gold standard method. All animal experiments were approved by the Johns Hopkins University Animal Care and Use Committee (Protocol No. MO21M378). Then, we obtained swab samples from 7 atopic dermatitis (AD) patients and compared our AST results with the ones from the gold standard method. The human subject protocol was approved by the Johns Hopkins Medicines Institutional Review Boards (Study No. CR00043438/IRB00307926) and by USAMRDC (Proposal Log Number/Study Number 20000251). High-quality data were obtained from the spiked samples of all 17 strains. A quantitative analysis model built using these data achieved 94% accuracy in predicting the species ID in 8 unknown samples. The AST results on the spiked samples had shown 100% matching with the gold standard method. Our system successfully detects the presence/absence of viable bacteria in all 3 mouse and 7 AD patient swab samples. Our system shows 100% and 85.7% (6 out of 7) accuracy when compared to the oxacillin susceptibility testing results for the mouse and the AD patient swabs, respectively. Our system has achieved excellent performance in detecting viable bacteria presence and in performing AST in a multiplex, automated, and easy-to-operate manner, on both lab-prepared and real samples. Our results have shown a path forward to a rapid (sample-to-answer time ≤3 hours), accurate, sensitive, species-specific, and portable system to detect the presence of MDR combat-related wound infections in the field environment. Our future efforts involve ruggedizing the RAPID system and evaluating performance under relevant environmental conditions.

Application and research advances of delayed sural neurotrophic vascular flap for diabetic foot ulcers

Diabetic foot ulcer is one of the serious complications of diabetes. Diabetic wounds are of great difficulty to repair, causing a high amputation rate and a great burden to patients and their family members and society. Researches showed that the delayed sural neurotrophic vascular flap has a great effect in repairing diabetic foot ulcers. This article mainly reviewed the clinical status and research advances of the delayed sural neurotrophic vascular flap in repairing diabetic foot ulcers, intending to provide a reference for its application and research.

IDF23-0360 Challenges in Managing Diabetic Foot: High Amputation Rates in Bejaia Province

IDF23-0360 Challenges in Managing Diabetic Foot: High Amputation Rates in Bejaia Province

Diabetic foot – prevention and control challenges

In a recent article Pérez Lozada Y, et al. described the characteristics and outcomes of 25 diabetic patients treated for foot ulcers; the majority of them were males, over 60 years of age, many with only the primary scholarity, and 5-10 years after the diagnosis of diabetes. Low socioeconomic level and inadequate glycemic control were the major factors for development of diabetic foot, besides smoking, obesity, and lack of shoes. Most patients improved in a short span of time, despite of high rate of amputations. Multidisciplinary care, and tissue regeneration medicines favored good outcomes. Additional comments, based on more recent literature data, are herein presented.

Is Unplanned Excision of Soft Tissue Sarcomas Associated with Worse Oncological Outcomes?-A Systematic Review and Meta-Analysis.

Soft tissue sarcomas are a group of rare neoplasms which can be mistaken for benign masses and be excised in a non-oncologic fashion (unplanned excision). Whether unplanned excision (UE) is associated with worse outcomes is highly debated due to conflicting evidence. We performed a systematic review and meta-analysis following PRISMA guidelines. Main outcomes analyzed were five-year overall survival (OS), five-year local recurrence-free survival (LRFS), amputation rate and plastic reconstruction surgery rate. Risk ratios were used to compare outcomes between patients treated with planned and unplanned excision. We included 16,946 patients with STS, 6017 (35.5%) with UE. UE was associated with worse five-year LRFS (RR 1.35, p = 0.019). Residual tumor on the tumor bed was associated with lower five-year LRFS (RR = 2.59, p < 0.001). Local recurrence was associated with worse five-year OS (RR = 1.82, p < 0.001). UE was not associated with a worse five-year OS (RR = 0.90, p = 0.16), higher amputation rate (RR = 0.77, p = 0.134), or a worse plastic reconstruction surgery rate (RR = 1.25, p = 0.244). Unplanned excision of Soft Tissue Sarcomas and the presence of disease in tumor bed after one were associated with worse five-year LRFS. Tumor bed excision should remain the standard approach, with special consideration to the presence of residual disease.

CORR Insights®: High Rates of Treatment Failure and Amputation in Modular Endoprosthesis Prosthetic Joint Infections Caused by Fungal Infections With Candida.

CORR Insights®: High Rates of Treatment Failure and Amputation in Modular Endoprosthesis Prosthetic Joint Infections Caused by Fungal Infections With Candida.

Debridement, Antibiotics, and Implant Retention (DAIR) Plus Offers Similar Periprosthetic Joint Infection Treatment Success Rates to Two-Stage Revision in Oncologic Megaprosthesis

BackgroundProsthetic joint infections (PJIs) after megaprosthesis implantation are associated with high rates of treatment failure and amputation. Our study analyzed PJI treatment success rates by surgical strategy and assessed risks of reinfection and amputation. MethodsWe retrospectively analyzed the outcomes of patients diagnosed with PJI after undergoing megaprosthesis implantation for oncologic indications. The 2011 Musculoskeletal Infection Society criteria were used to define PJI. Reinfection, reoperation, and amputation for PJI recurrence were assessed. A total of 67 patients with megaprosthesis PJIs were included. There were fourteen patients who were treated with debridement, antibiotics, and implant retention (DAIR), 31 with DAIR plus (DAIR with modular component exchange and stem retention), and 21 with two-stage revisions. Kaplan-Meier estimates were used for survival analyses and Cox proportional hazards for risk factor analyses. ResultsThe two-year reinfection-free survival was 25% for DAIR and 60% for DAIR plus or two-stage revision (P = .049). The five-year amputation-free survival was 84% for DAIR plus or two-stage revision, and 48% for DAIR (P = .13). Reinfection-free, reoperation-free, and amputation-free survival were similar between DAIR plus and two-stage revision at the 2- and 5-year marks. Body mass index ≥30 (hazard ratio [HR] = 2.65) and chronic kidney disease (HR = 11.53) were risk factors for reinfection. Treatment with DAIR plus or two-stage revision (HR = 0.44) was a protective factor against reinfection. ConclusionsA DAIR was associated with high rates of treatment failure and higher amputation rates than DAIR plus or 2-stage surgery. A DAIR plus was not inferior to 2-stage revision clearing a PJI and might be performed in patients who cannot withstand two-stage revision surgery.

Identifying and Validating Extracellular Matrix-Related Gene CTSH in Diabetic Foot Ulcer Using Bioinformatics and Machine Learning.

Diabetic foot ulcer (DFU) is a serious clinical problem with high amputation and mortality rates, yet there is a lack of desirable therapy. While the extracellular matrix (ECM) contributes significantly to wound healing, ECM-related biomarker for DFU is still unknown. The study was designed to identify ECM-related biomarker in DFU using bioinformatics and machine learning and validate it in STZ-induced mice models. GSE80178 and GSE134431 microarray datasets were fetched from the GEO database, and differentially expressed genes (DEGs) analysis was performed, respectively. By analyzing DEGs and ECM genes, we identified ECM-related DEGs, and functional enrichment analysis was conducted. Subsequently, three machine learning algorithms (LASSO, RF and SVM-RFE) were applied to filter ECM-related DEGs to identify key ECM-related biomarkers. Next, we conducted immune infiltration analysis, GSEA, and correlation analysis to explore the hub gene underlying mechanism. A lncRNA-miRNA-mRNA and drug regulatory network were constructed. Finally, we validated the key ECM-related biomarker in STZ-induced mice models. One hundred and forty-five common DEGs in adult DFU between the two datasets were identified. Taking the intersection of 145 common DEGs and 964 ECM genes, we identified 13 ECM-related DEGs. Thirteen ECM-related DEGs were mainly enriched in pathways associatedwith tissue remodeling, inflammation and defense against infectious agents. Ultimately, CTSH was identified as the key ECM-related biomarker. CTSH was associated with difference immune cells during the occurrence and development of DFU, and it influenced hedgehog, IL-17 and TNF signaling pathway. Additionally, CTSH expression is correlated with many ECM- and immune-related genes. A lncRNA-miRNA-mRNA and drug regulatory network were constructed with 10 lncRNAs, 2 miRNAs, CTSH and 1 drug. Finally, CTSH was validated as a key biomarker for DFU in animal models. Our study found that CTSH can be used for both diagnostic and prognostic purposes and might be a potential therapeutic target.

Chronic Limb-Threatening Ischemia does not Enclose a Homogenous Population: Time for a More Detailed Classification.

Objective Chronic limb-threatening ischemia (CLTI) is associated with high morbidity and mortality. Classification methods differentiate into patients with rest pain or with ischemic ulcers. No distinction is made between the presence or absence of rest pain in patients with ischemic ulcers. Our aim is to determine any differences in outcome between these subdivisions so we can improve preoperative counseling and risk assessment. Materials and Methods This multicenter retrospective cohort study included all patients revascularized for a first episode of CLTI between 2013 and 2018. The cohort was divided in three groups: patients with solely rest pain (RP), solely ischemic ulcers (IU), and patients with both rest pain and ischemic ulcers (RP + IU). Baseline characteristics, morbidity, and mortality were analyzed. Results A total of 624 limbs in 599 patients were included: 225 (36.1%) in the rest pain group, 169 (27.1%) in the ischemic ulcers group, and 230 (36.2%) in combined group. Amputation rates were higher in the combined group at 6 months. Mortality rates were significantly higher in the ischemic ulcers group and the combined group at 6 months and 1 year. Conclusion Patients with solely rest pain have significantly lower mortality rates in comparison to patients with ischemic ulcers. Rest pain did not affect mortality rates in patients with ulcers. There was a higher amputation rate in patients with combined rest pain and ischemic ulcers because the presence of rest pain CLTI patients had a significant negative effect on amputation risk. A separate subdivision for patients with combined ulcers and rest pain is indicated.

Co-Delivery of Bioengineered Exosomes and Oxygen for Treating Critical Limb Ischemia in Diabetic Mice.

Diabetic patients with critical limb ischemia face a high rate of limb amputation. Regeneration of the vasculature and skeletal muscles can salvage diseased limbs. Therapy using stem cell-derived exosomes that contain multiple proangiogenic and promyogenic factors represents a promising strategy. Yet the therapeutic efficacy is not optimal because exosomes alone cannot efficiently rescue and recruit endothelial and skeletal muscle cells and restore their functions under hyperglycemic and ischemic conditions. To address these limitations, we fabricated ischemic-limb-targeting stem cell-derived exosomes and oxygen-releasing nanoparticles and codelivered them in order to recruit endothelial and skeletal muscle cells, improve cell survival under ischemia before vasculature is established, and restore cell morphogenic function under high glucose and ischemic conditions. The exosomes and oxygen-releasing nanoparticles, delivered by intravenous injection, specifically accumulated in the ischemic limbs. Following 4 weeks of delivery, the exosomes and released oxygen synergistically stimulated angiogenesis and muscle regeneration without inducing substantial inflammation and reactive oxygen species overproduction. Our work demonstrates that codelivery of exosomes and oxygen is a promising treatment solution for saving diabetic ischemic limbs.

Disparities in Diagnosis, Treatment, andOutcomes of Peripheral ArteryDisease: JACC Scientific Statement.

Disparities by sex, race, socioeconomic status, and geography exist in diagnosis, treatment, and outcomes for people with lower extremity peripheral artery disease (PAD). PAD prevalence is similar in men and women, but women have more atypical symptoms and undergo lower extremity revascularization at older ages compared to men. People who are Black have an approximately 2-fold higher prevalence of PAD, compared to people who are White and have more atypical symptoms, greater mobility loss, less optimal medical care, and higher amputation rates. Although fewer data are available for other races, people with PAD who are Hispanic have higher amputation rates than White people. Rates of amputation also vary by geography in the United States, with the highest rates of amputation in the southeastern United States. To improve PAD outcomes, intentional actions to eliminate disparities are necessary, including clinician education, patient education with culturally appropriate messaging, improved access to high-quality health care, science focused on disparity elimination, and health policy changes.

Comorbid status in patients with osteomyelitis is associated with long-term incidence of extremity amputation

IntroductionOsteomyelitis is associated with significant morbidity, including amputation. There are limited data on long-term amputation rates following an osteomyelitis diagnosis. We sought to determine the incidence of amputation in patients...

Endovascular and Surgical Venous Arterialization for No-Option Patients With Chronic Limb-Threatening Ischemia: A Systematic Review and Meta-Analysis.

Chronic limb-threatening ischemia (CLTI) is known for its high rates of major amputation and mortality. Conventional revascularization techniques often fail in CLTI patients due to the heavily diseased arteries. Foot vein arterialization (FVA) has been proposed as an alternative technique to provide arterial blood to the foot by using the disease-free venous bed. This systematic review and meta-analysis aimed to determine outcomes of surgical FVA (sFVA) and percutaneous FVA (pFVA) at 6 and 12 months post-procedure. PubMed, Scopus, Web of Science, and the Cochrane Library databases were searched to identify papers reporting clinical outcomes of sFVA and pFVA published between January 1966 and March 2023. Databases were searched for eligible studies. A meta-analysis was performed to evaluate the limb salvage rate, overall survival rate, and wound healing rate at 6 and 12 months. A total of 27 studies were included, with 753 patients and 793 limbs. Of the included studies, 16 analyzed the sFVA technique and 11 the pFVA technique. Of the included patients, 86.3% were Rutherford 5/6 in the sFVA group versus 98.4% in the pFVA group. The pooled limb salvage rate at 6 and 12 months was 78.1% and 74.1% in the sFVA group and 81.7% and 78.6% in the pFVA group, respectively. Wound healing rates were not reported in the sFVA group. In the pFVA group, the pooled wound healing rates were 48.1% and 64.5% at 6 and 12 months, respectively. This study showed promising results after FVA among a large population of CLTI patients. In high-risk patients, pFVA is a feasible option with favorable limb salvage and wound healing rates.

Mechanical characteristics of diabetic and non-diabetic plantar skin

Diabetic foot ulceration is linked to high amputation and mortality rates, with the substantial associated annual spend on the at-risk diabetic foot reflecting the intensive time and labour involved in treatment. Assessing plantar interactions and developing improved understanding of the formation pathways of diabetic ulceration is important to orthotic interventions and patient outcomes. Plantar skin surrogates which emulate the mechanical and tribological characteristics can help improve physical models of ulceration, reduce reliance on cadaveric use and inform more complex computational modelling approaches. The information available from existing studies to characterise plantar skin is limited, typically featuring ex-vivo representations of skin and subcutaneous tissue combined and given focus to shear studies with time dependency. The aim of this study is to improve understanding of plantar tissue mechanics by assessing the mechanical characteristics of plantar skin in two groups; (1) non-diabetic and (2) diabetic donors without the subcutaneous tissue attachment of previous work in this field. Digital image correlation was used to assess inherent skin pre-tension of the plantar rearfoot prior to dissection. Young’s modulus, storage and loss moduli were tested for using tensile stress–strain failure analysis and tensile and compressive dynamic mechanical analysis, which was conducted on excised plantar rearfoot donor specimens for both disease state cohorts at frequencies reflecting those achieved in activities of daily living. Plantar skin thickness for donor specimens were comparable to values obtained using ultrasound acquired in vivo values. Median tensile storage and loss moduli, along with Young’s modulus, was higher in the diabetic cohort. With a mean Young’s modulus of 0.83 ± 0.49 MPa and 1.33 ± 0.43 MPa for non-diabetic and diabetic specimens respectively. Compressive studies showed consistency between cohorts for median storage and loss moduli. The outcomes from this study show mechanical characteristics of plantar skin without the involvement of subcuteanous tissues under reflective daily achieved loading regimes, showing differences in the non-diabetic and diabetic specimens trialled to support improved understanding of plantar tissue response under tribological interactions.

High Rates of Treatment Failure and Amputation in Modular Endoprosthesis Prosthetic Joint Infections Caused by Fungal Infections With Candida.

Fungal prosthetic joint infections (PJIs) are rare yet severe events associated with high rates of recurrent infection. Although bacterial PJIs associated with megaprostheses are known to be associated with higher rates of recurrence and amputation, little is known about fungal PJIs near megaprostheses. In patients with fungal megaprosthesis PJIs from one institutional registry, we asked: (1) What were the most common microorganisms isolated? (2) What were the reoperation-, revision-, and amputation-free survival rates 1 and 2 years after surgery? We conducted a retrospective analysis of megaprostheses in our institutional database. Between 2000 and 2022, 86 patients with a diagnosis of PJI after megaprosthesis implantation were surgically treated at our institution. We considered patients with microbiological cultures that were positive for fungal organisms and who had a minimum follow-up of 2 years from the initial treatment for PJI. Ten patients with fungal megaprosthesis PJIs were included. Although four patients had a follow-up shorter than 2 years, all reached one of the study endpoints at that earlier interval, and therefore were included. All included patients were treated between 2016 and 2022, and the diagnosis of PJI was made in accordance with the 2011 Musculoskeletal Infection Society criteria. Patients were treated with either debridement, antibiotics, and implant retention (DAIR), DAIR-plus (debridement, antibiotics, modular implant component exchange, and stem retention), or one-stage or two-stage revision. In general, DAIR was used for acute PJIs, while DAIR-plus was performed in patients with chronic PJIs who were deemed medically unfit to endure the high morbidity associated with removal of the stems. In cases of prior unsuccessful DAIR-plus or patients with fewer comorbidities, one-stage or two-stage revision was the main treatment approach. The median age at diagnosis was 67 years (range 32 to 84 years), 5 of 10 patients were female, and the median BMI was 31 kg/m 2 (range 20 to 43 kg/m 2 ). The median follow-up was 26 months (range 1 to 54 months). A Kaplan-Meier survival analysis was performed to calculate reoperation-, revision-, and amputation-free survival at 1 and 2 years from the index surgery for PJI. The two most common organisms were Candida albicans (5 of 10 patients) and C.parapsilosis (3 of 10). Six of 10 patients had coinfection with a bacterial organism. One-year reoperation-free and revision-free survival were 35% (95% CI 9% to 64%) and 42% (95% CI 11% to 71%), respectively. Two-year reoperation-free and revision-free survival were 12% (95% CI 1% to 40%) and 14% (95% CI 1% to 46%), respectively. Amputation-free survival was 74% (95% CI 30% to 93%) at the 1-year interval and 40% at the 2-year interval (95% CI 7% to 73%). At the final follow-up interval, four patients had undergone amputations and four were being administered chronic antifungal suppression. Megaprosthesis fungal PJIs are rare but devastating. Arthroplasty surgeons should consider treatment efficacy, which appears to be low across surgical strategies, and the patient's capacity to withstand it. A lower decision threshold for performing amputation may be considered in patients who require rapid infection control to initiate immunosuppressive treatments. Future studies should aim to compare the surgical and clinical outcomes of fungal PJIs with those of other etiologies while controlling for potential variables. Efforts should be made to establish multi-institutional collaborations to achieve larger study samples. Level IV, therapeutic study.

Global healthcare pathway of people living with diabetes prior to wounding is associated with a decreased risk of amputation

AimsDiabetic foot ulcer (DFU) has a poor prognosis and high amputation rate. We previously used the French National Health Data System (Système National des Données de Santé: SNDS) to analyze the impact of deprivation and healthcare access on DFU prognosis. The purpose of this ancillary study was to explore the relationship between the global care pathway (care consumption) the year before and after DFU and the risk of amputation. MethodsWe conducted a study based on a cohort from the SNDS. The data came from a region of France and subjects living with a complication of DFU. We looked at care consumption one year before and one year after wound onset. Risk of amputation was calculated one year after DFU onset. ResultsData were extracted for 6,642 patients. Subjects with DFU had a better prognosis regarding amputation risk when they are taking cardiovascular, antibiotic, neurological, drugs. A consultation with an ophthalmologist was also linked to a better prognosis: HR = 0.71 IC95 (0.499–0.995) (p = 0.04). ConclusionPeople with the best diabetes follow-up, even with several comorbidities, appear to have a better prognosis for their DFU. This highlights the importance of global healthcare and the care pathway in this chronic disease.

Histone Mono-methylation by SETD7 Orchestrates Angiogenic Response in Diabetic Limb Ischemia

Abstract Background Peripheral artery disease (PAD) is highly prevalent in patients with diabetes (DM) and associates with a high rate of limb amputation and poor prognosis. Surgical and catheter-based revascularization have failed to improve outcome in DM patients with PAD. Hence, a need exists to develop new treatment strategies able to promote blood vessel growth in this setting. Mono-methylation of histone 3 at lysine 4 (H3K4me1) - a specific epigenetic signature induced by the histone methyltransferase SETD7 - favours an open chromatin thus enabling gene transcription. Purpose: To investigate whether SETD7-dependent epigenetic changes modulate angiogenic response in diabetes. Methodology: Primary human aortic endothelial cells (HAECs) were exposed to normal glucose (NG, 5 mM) or high glucose (HG, 25 mM) concentrations for 48 hours. Unbiased gene expression profiling was performed by RNA sequencing (RNA-seq) followed by Ingenuity Pathway Analysis (IPA). In vitro assays, namely cell migration and tube formation were employed to study angiogenic properties in HAECs. SETD7 and H3K4me1 levels were investigated by Western blot and Chromatin immunoprecipitation (ChIP). Pharmacological blockade of SETD7 was achieved by using the highly selective inhibitor (R)-PFI-2. Mice with streptozotocin-induced diabetes were orally treated with (R)-PFI-2 or vehicle and underwent hindlimb ischemia by femoral artery ligation for 14 days. Blood flow recovery was analysed at 30 minutes, 7 and 14 days by laser Doppler imaging. Our experimental findings were also translated in gastrocnemius muscle samples from patients with and without diabetes. Results RNA-seq in HG-treated HAECs revealed a profound upregulation of the methyltransferase SETD7, an enzyme involved in mono-methylation of lysine 4 at histone 3 (H3K4me1). SETD7 upregulation in HG-treated HAECs was associated with increased H3K4me1 levels as well as with impaired endothelial cell migration and tube formation. Both SETD7 gene silencing and pharmacological inhibition by (R)PFI-2 rescued hyperglycemia-induced impairment of HAECs migration and tube formation, while SETD7 overexpression blunted the angiogenic response. RNA-seq and ChIP assays showed that SETD7-dependent H3K4me1 regulates the transcription of the angiogenesis inhibitor semaphorin-3G (SEMA-3G, (Figure 1). Moreover, SEMA-3G overexpression blunted migration and tube formation in SETD7-depleted HAECs. In diabetic mice with hindlimb ischemia, treatment with (R)-PFI-2 improved limb vascularization and perfusion as compared to vehicle (Figure 2). Finally, SETD7/SEMA3G axis was upregulated in muscle specimens from T2D patients as compared to controls (Figure 2) Conclusion: Targeting SETD7 represents a novel epigenetic-based therapy to boost neovascularization in diabetic patients with PAD.

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

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

Safety and efficacy of mechanical aspiration thrombectomy for patients with acute lower extremity ischemia

ObjectiveAcute limb ischemia (ALI) is associated with high rates of amputation and consequent morbidity and mortality. The objective of this study is to report on the safety and efficacy of aspiration thrombectomy using the Indigo Aspiration System in patients with lower extremity (LE) ALI. MethodsThe STRIDE study was an international, multicenter, prospective, study that enrolled 119 participants presenting with LE-ALI. Patients were treated firstline with mechanical thrombectomy using the Indigo Aspiration System, before stenting or angioplasty, or other therapies as determined by treating physician. The primary end point was target limb salvage at 30 days after the procedure. Secondary end points within 30 days included technical success, defined as core laboratory-adjudicated Thrombolysis in Myocardial Infarction (TIMI) 2/3 flow rate immediately after the procedure, changes in modified Society for Vascular Surgery runoff score, improvement of Rutherford classification compared with before the procedure, patency, rate of device-related serious adverse events, and major periprocedural bleeding. Secondary end points that will be evaluated at 12 months include target limb salvage and mortality. ResultsOf the 119 participants enrolled at 16 sites, the mean age was 66.3 years (46.2% female). At baseline (n = 119), ischemic severity was classified as Rutherford I in 10.9%, Rutherford IIa in 54.6%, and Rutherford IIb in 34.5%. The mean target thrombus length was 125.7 ± 124.7 mm. Before the procedure, 93.0% (of patients 107/115) had no flow (TIMI 0) through the target lesion. The target limb salvage rate at 30 days was 98.2% (109/111). The rate of periprocedural major bleed was 4.2% (5/119) and device-related serious adverse events was 0.8% (1/119). Restoration of flow (TIMI 2/3) was achieved in 96.3% of patients (105/109) immediately after the procedure. The median improvement in the modified Society for Vascular Surgery runoff score (before vs after the procedure) was 6.0 (interquartile range, 0.0-11.0). Rutherford classifications also improved after discharge in 86.5% of patients (83/96), as compared with preprocedural scores. Patency at 30 days was achieved in 89.4% of patients (101/113). ConclusionsIn the STRIDE (A Study of Patients with Lower Extremity Acute Limb Ischemia to Remove Thrombus with the Indigo Aspiration System) study, aspiration thrombectomy with the Indigo System provided a safe and effective endovascular treatment for patients with LE-ALI, resulting in a high rate (98.2%) of successful limb salvage at 30 days, with few periprocedural complications.

Vascular Reconstruction and Limb Loss in Military Tibial Artery Injuries

Selective operative management of injuries to the tibial arteries is controversial, with the necessity of revascularization in the face of multiple tibial arteries debated. Tibial artery injuries are frequently encountered in military trauma, but revascularization practices and outcomes are poorly defined. We aimed to investigate associations between the number of injured vessels and reconstruction and limb loss rates in military casualties with tibial arterial trauma. A US military database of lower extremity vascular injuries from Iraq and Afghanistan (2004-2012) was queried for limbs sustaining at least 1 tibial artery injury. Injury, intervention characteristics, and limb outcomes were analyzed by the number of tibial arteries injured (1, T1; 2, T2; 3, T3). Two hundred twenty one limbs were included (194 T1, 22 T2, 5 T3). The proportions with concomitant venous, orthopedic, nerve, or proximal arterial injuries were similar between groups. Arterial reconstruction (versus ligation) was performed in 29% of T1, 63% of T2, and universally in T3 limbs (P<0.001). Arterial reconstruction was via vein graft (versus localized repair) in 62% of T1, 54% of T2, and 80% of T3 (P=0.59). T3 received greater blood transfusion volume (P=0.02), and fasciotomy was used universally (versus 34% T1 and 14% T2, P=0.05). Amputation rates were 23% for T1, 26% for T2, and 60% for T3 (P=0.16), and amputation was not significantly predicted by arterial ligation in T1 (P=0.08) or T2 (P=0.34) limbs. Limb infection was more common in T3 (80%) than in T1 (25%) or T2 (32%, P=0.02), but other limb complication rates were similar. In this series of military lower extremity injuries, an increasing number of tibial arteries injured was associated with the increasing use of arterial reconstruction. Limbs with all 3 tibial arteries injured had high rates of complex vascular reconstruction and eventual amputation. Limb loss was not predicted by arterial ligation in 1-vessel and 2-vessel injuries, suggesting that selective reconstruction in these cases is advisable.