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1,268 result(s) for "Limb salvage"
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Surgery or Endovascular Therapy for Chronic Limb-Threatening Ischemia
Patients with chronic limb-threatening ischemia (CLTI) require revascularization to improve limb perfusion and thereby limit the risk of amputation. It is uncertain whether an initial strategy of endovascular therapy or surgical revascularization for CLTI is superior for improving limb outcomes. In this international, randomized trial, we enrolled 1830 patients with CLTI and infrainguinal peripheral artery disease in two parallel-cohort trials. Patients who had a single segment of great saphenous vein that could be used for surgery were assigned to cohort 1. Patients who needed an alternative bypass conduit were assigned to cohort 2. The primary outcome was a composite of a major adverse limb event - which was defined as amputation above the ankle or a major limb reintervention (a new bypass graft or graft revision, thrombectomy, or thrombolysis) - or death from any cause. In cohort 1, after a median follow-up of 2.7 years, a primary-outcome event occurred in 302 of 709 patients (42.6%) in the surgical group and in 408 of 711 patients (57.4%) in the endovascular group (hazard ratio, 0.68; 95% confidence interval [CI], 0.59 to 0.79; P<0.001). In cohort 2, a primary-outcome event occurred in 83 of 194 patients (42.8%) in the surgical group and in 95 of 199 patients (47.7%) in the endovascular group (hazard ratio, 0.79; 95% CI, 0.58 to 1.06; P = 0.12) after a median follow-up of 1.6 years. The incidence of adverse events was similar in the two groups in the two cohorts. Among patients with CLTI who had an adequate great saphenous vein for surgical revascularization (cohort 1), the incidence of a major adverse limb event or death was significantly lower in the surgical group than in the endovascular group. Among the patients who lacked an adequate saphenous vein conduit (cohort 2), the outcomes in the two groups were similar. (Funded by the National Heart, Lung, and Blood Institute; BEST-CLI ClinicalTrials.gov number, NCT02060630.).
Plain versus drug balloon and stenting in severe ischaemia of the leg (BASIL-3): open label, three arm, randomised, multicentre, phase 3 trial
AbstractObjectiveTo determine which primary endovascular revascularisation strategy represents the most clinically effective treatment for patients with chronic limb threatening ischaemia who require endovascular femoro-popliteal, with or without infra-popliteal, revascularisation.DesignThree arm, open label, pragmatic, multicentre, randomised, phase 3 superiority trial (BASIL-3).Setting35 UK NHS vascular units.ParticipantsPatients with chronic limb threatening ischaemia who required endovascular femoro-popliteal, with or without infra-popliteal, revascularisation.InterventionsParticipants were randomly assigned (1:1:1) to femoro-popliteal plain balloon angioplasty with or without bare metal stenting (PBA±BMS), drug coated balloon angioplasty with or without bare metal stenting (DCBA±BMS), or drug eluting stenting (DES) as their first revascularisation strategy.Main outcome measuresThe primary outcome was amputation free survival defined as time to first major amputation or death from any cause. Secondary outcomes included the composite components of the primary outcome, major adverse limb events, major adverse cardiac events, and other prespecified clinical and patient reported outcome measures. Serious adverse events were collected up to 30 days after the first revascularisation procedure.ResultsBetween 29 January 2016 and 31 August 2021, 481 participants were randomised (167 (35%) women, mean age 71.8 years (standard deviation 10.8)). Major amputation or death occurred in 106 of 160 (66%) participants in the PBA±BMS group, 97 of 161 (60%) in the DCBA±BMS group, and 93 of 159 (58%) in the DES group (adjusted hazard ratios: PBA±BMS v DCBA±BMS: 0.84, 97.5% confidence interval 0.61 to 1.16, P=0.22; PBA±BMS v DES: 0.83, 0.60 to 1.15, P=0.20). No differences in serious adverse events were reported between the groups.ConclusionsNeither DCBA±BMS nor DES conferred significant clinical benefit over PBA±BMS in the femoro-popliteal segment in patients with chronic limb threatening ischaemia undergoing endovascular femoro-popliteal, with or without infra-popliteal, revascularisation.Trial registrationISRCTN registry ISRCTN14469736
Transcatheter Arterialization of Deep Veins in Chronic Limb-Threatening Ischemia
Approximately 20% of patients with chronic limb-threatening ischemia have no revascularization options, leading to above-ankle amputation. Transcatheter arterialization of the deep veins is a percutaneous approach that creates an artery-to-vein connection for delivery of oxygenated blood by means of the venous system to the ischemic foot to prevent amputation. We conducted a prospective, single-group, multicenter study to evaluate the effect of transcatheter arterialization of the deep veins in patients with nonhealing ulcers and no surgical or endovascular revascularization treatment options. The composite primary end point was amputation-free survival (defined as freedom from above-ankle amputation or death from any cause) at 6 months, as compared with a performance goal of 54%. Secondary end points included limb salvage, wound healing, and technical success of the procedure. We enrolled 105 patients who had chronic limb-threatening ischemia and were of a median age of 70 years (interquartile range, 38 to 89). Of the patients enrolled, 33 (31.4%) were women and 45 (42.8%) were Black, Hispanic, or Latino. Transcatheter arterialization of the deep veins was performed successfully in 104 patients (99.0%). At 6 months, 66.1% of the patients had amputation-free survival. According to Bayesian analysis, the posterior probability that amputation-free survival at 6 months exceeded a performance goal of 54% was 0.993, which exceeded the prespecified threshold of 0.977. Limb salvage (avoidance of above-ankle amputation) was attained in 67 patients (76.0% by Kaplan-Meier analysis). Wounds were completely healed in 16 of 63 patients (25%) and were in the process of healing in 32 of 63 patients (51%). No unanticipated device-related adverse events were reported. We found that transcatheter arterialization of the deep veins was safe and could be performed successfully in patients with chronic limb-threatening ischemia and no conventional surgical or endovascular revascularization treatment options. (Funded by LimFlow; PROMISE II study ClinicalTrials.gov number, NCT03970538.).
Limb salvage versus amputation in patients with osteosarcoma of the extremities: an update in the modern era using the National Cancer Database
Background Historically, amputation was the primary surgical treatment for osteosarcoma of the extremities; however, with advancements in surgical techniques and chemotherapies limb salvage has replaced amputation as the dominant treatment paradigm. This study assessed the type of surgical resection chosen for osteosarcoma patients in the twenty-first century. Methods Utilizing the largest registry of primary osteosarcoma, the National Cancer Database (NCDB), we retrospectively analyzed patients with high grade osteosarcoma of the extremities from 2004 through 2015. Differences between patients undergoing amputation and patients undergoing limb salvage are described. Unadjusted five-year overall survival between patients who received limb salvage and amputation was assessed utilizing Kaplan Meier curves. A multivariate Cox proportional hazard model and propensity matched analysis was used to determine the variables independently correlated with survival. Results From a total of 2442 patients, 1855 underwent limb salvage and 587 underwent amputation. Patients undergoing amputation were more likely to be older, male, uninsured, and live in zip codes associated with lower income. Patients undergoing amputation were also more likely to have larger tumors, more comorbid conditions, and metastatic disease at presentation. After controlling for confounders, limb salvage was associated with a significant survival benefit over amputation (HR: 0.70; p  < 0.001). Although this may well reflect underlying biases impacting choice of treatment, this survival benefit remained significant after propensity matched analysis of all significantly different independent variables (HR: 0.71; p  < 0.01). Conclusion Among patients in the NCDB, amputation for osteosarcoma is associated with advanced age, advanced stage, larger tumors, greater comorbidities, and lower income. Limb salvage is associated with a significant survival benefit, even when controlling for significant confounding variables and differences between cohorts.
Surgical outcomes of limb-salvage surgery with or without femoral vein reconstruction for soft tissue sarcomas of the thigh
Background Limb salvage surgery for thigh soft tissue sarcomas (STSs) involving the femoral vasculature often necessitates arterial reconstruction. However, whether femoral vein reconstruction is needed remains controversial. Purposes This study aimed to evaluate the outcomes of limb salvage procedures utilizing femoral vessel replacement in patients diagnosed with thigh soft tissue sarcomas involving the femoral vasculature. Method We conducted a retrospective review of patients with thigh STSs who underwent limb salvage surgery and vascular reconstruction. Twelve patients were enrolled and divided into two groups on the basis of whether femoral vein was reconstructed. Five received femoral artery and vein reconstruction (group A) and seven were treated with femoral artery reconstruction alone (group B). In our cohort, vascular reconstructions were predominantly performed with prosthetic grafts due to the unavailability of suitable autologous conduits or patient preference, while only two patients received autologous venous grafts. We used the Enneking and Musculoskeletal Tumor Society (MSTS) systems to stage our patients. We assessed complications, MSTS function, local recurrence and survival. Results All patients were Enneking IIB. A wide margin excision was achieved in all patients. The great saphenous vein was preserved in group A (2/5) and group B (3/7). The mean age of the patients for group A and group B was 50.8 and 43.7 years, respectively. The median follow-up period for group A and group B was 50 months (range, 30–77 months) and 43 months (range, 24–62 months), respectively. The mean operation time of Group B was substantially less than that of group A ( P <0.05). There was a significant difference in the venous embolism rate between group A(3/5) and group B in the perioperative period. No significant differences were found between the two groups in terms of hematoma formation, delayed wound healing, incision infection rate, reoperation rate, overall disease-free survival, 2-year arterial patency rate and limb salvage rate. No patient had local recurrence and one case in group B developed metastasis. The mean Musculoskeletal Tumor Society score of group A and group B at the final follow-up was 23 points and 25 points, respectively. Conclusions Femoral arterial reconstruction alone effectively treats thigh STSs involving the femoral vasculature while femoral vein reconstruction does not significantly improve management in these cases. Level of evidence IV.
Guideline for Limb‐Salvage Treatment of Osteosarcoma
Osteosarcoma is the most common primary malignant bone tumor, occurring mainly in children and adolescents, and the limbs are the main affected sites. At present, limb‐salvage treatment is considered as an effective basic standard treatment for osteosarcoma of the limb. China has a vast territory, but the development of technology is not balanced,which requires sufficient theoretical coverage, strong technical guidance and the application of limb‐salvage treatment guidelines to the treatment of osteosarcoma. Therefore, to standardize and promote the development of limb‐salvage surgery technology and improve the success rate of limb‐salvage treatment, this guide systematically introduces limb‐salvage techniques for the treatment of patients with limb osteosarcoma through definition of limb‐salvage treatment, surgical methods, efficacy evaluation, postoperative treatment and prevention of complications, rehabilitation guidance, and follow‐up advice.
Percutaneous Deep Venous Arterialization Using an IVUS-Guided Technique in no-Option Patients with Chronic Limb-Threatening Ischemia: 24-Month Results
In some patients, revascularization is not possible or is not effective. For these, percutaneous deep vein arterialization (p-DVA) could be considered an alternative treatment. The aim of this study is to evaluate the long-term results of an intravascular ultrasound (IVUS)-guided technique that has only one percutaneous access. This is a prospective monocentric study on 18 no-option CLTI limbs treated with an IVUS-guided p-DVA. The primary outcome measures are: the freedom from major adverse events (MAEs) and survival at 30 days; limb salvage and amputation free survival (AFS) at 30 days, 6 months, 12 months and 24 months. The secondary outcome measures are: procedural success, survival, patency and wound healing. We treated 14 patients with no-option CLTI, carrying out 18 p-DVA. Median age was 74,4 years (60-87). All these patients had a previous failed angioplasty of the tibial and foot arteries. Procedural success rate, defined as the establishment of arterial flow into the venous system of the foot, was 100%. No deaths and MAEs recorded at 30 days. Survival was 100%, 83.4% and 77.8%; limb salvage was 88.9%, 77.8% and 77.8%; AFS was 88.9%, 61.1% and 55.6% at 6, 12 and 24 months. Complete wound healing was 18.7% at 6 months, 80.0% at 12 months and 100% at 24 months. Based on these results, the IVUS-guided p-DVA seems to be safe and effective for no-option CLTI patients, with no mortality related to the intervention, an acceptable limb salvage rate and amputation free survival.
High Infection Rate Outcomes in Long-bone Tumor Surgery with Endoprosthetic Reconstruction in Adults: A Systematic Review
Background Limb salvage surgery (LSS) with endoprosthetic replacement is the most common method of reconstruction following bone tumor resection in the adult population. The risk of a postoperative infection developing is high when compared with conventional arthroplasty and there are no appropriate guidelines for antibiotic prophylaxis. Questions/purposes We sought to answer the following questions: (1) What is the overall risk of deep infection and the causative organism in lower-extremity long-bone tumor surgery with endoprosthetic reconstruction? (2) What antibiotic regimens are used with endoprosthetic reconstruction? (3) Is there a correlation between infection and either duration of postoperative antibiotics or sample size? Methods We conducted a systematic review of the literature for clinical studies that reported infection rates in adults with primary bony malignancies of the lower extremity treated with surgery and endoprosthetic reconstruction. The search included articles published in English between 1980 and July 2011. Results The systematic literature review yielded 48 studies reporting on a total of 4838 patients. The overall pooled weighted infection rate for lower-extremity LSS with endoprosthetic reconstruction was approximately 10% (95% CI, 8%–11%), with the most common causative organism reported to be Gram-positive bacteria in the majority of cases. The pooled weighted infection rate was 13% after short-term postoperative antibiotics and 8% after long-term postoperative antibiotics. There was no correlation between sample size and infection rate. Conclusions Infection rates of 10% are high when compared with rates for conventional arthroplasty. Our results suggest that long-term antibiotic prophylaxis decreases the risk of deep infection. However, the data should be interpreted with caution owing to the retrospective nature of the studies.
Ring-and-flap: a novel and accessible alternative to fix-and-flap in Gustilo IIIB-C open tibia fractures (an institutional experience)
Background The fix-and-flap regime is resource intense and may not be readily available. As an alternative, the ring fixator serves as a versatile option for limb salvage, however it poses challenges to soft tissue reconstruction due to the limited working space around the rings and pins. We describe an institutional experience with a novel ring-and-flap regime utilising an open ring technique—which optimises the ring fixator construct for the flexibility of interval soft-tissue reconstruction. Methods A retrospective review of patients treated with a novel ring-and-flap regime over 2017–2024 was conducted. Demographic data, comorbidities, intraoperative details, and postoperative outcomes were collected. Results 6 patients were included. Soft tissue reconstruction took place at a median of 12 days (minimum 2, maximum 154) after ring fixation. The median duration on the ring fixator was 144 days (minimum 74, maximum 270). Most patients (4/6) developed osteomyelitis but all achieved union and regained ambulatory function. 2/6 required flap revision due to vascular thrombosis. The ring fixator served as definitive fixation in 2 patients; whilst the remainder opted for internalisation. Conclusion The novel ring-and-flap regime may provide a practical and safe pathway for limb salvage in resource limited settings, bridging the gap until specialised ortho-plastics care is available.
Joint-preservation surgery for pediatric osteosarcoma of the knee joint
The multi-disciplinary approach involving imaging, multi-agent chemotherapy, meticulous surgical procedures, and careful postoperative care has facilitated an increase in the use of limb-sparing surgery for pediatric osteosarcoma. Osteosarcoma usually occurs around the metaphysis of the distal femur or proximal tibia and needs wide excision with the adjacent joint and replacement by a megaprosthesis. The recent advancement in imaging modalities and surgical techniques supports joint-preservation surgery (JPS), involving the preservation of the adjacent epiphysis, for select patients following careful assessment of the tumor margins and precise tumor excision. An advantage of this surgery is that it maintains the adjacent joint and preserves the growth of the residual epiphysis, which provides excellent limb function. Various reconstruction options are available, including allograft, tumor-devitalized autograft, vascularized fibula graft, distraction osteogenesis, and custom-made implants. However, several complications are inevitable with these options, such as loosening, non-union at the host-graft junction, infection, fracture, implant loosening, breakage, deformity, limb-length discrepancy related to the reconstruction methods, or patient growth in pediatric osteosarcoma. Surgeons should fully understand the advantages and disadvantages of this procedure. In this review, we discuss the concept of JPS, types of reconstruction methods, and current treatment outcomes. It is our opinion that the further analysis by multi-institutional setting is necessary to clarify long-term outcomes and establish global guidelines on the indications and surgical procedure for JPS.