Survivorship, Complications, and Outcomes Following Distal Femoral Replacement Using Megaprosthesis

Introduction: Distal femoral bone loss is often managed with a combination of modular prostheses, structural and non-structural allografts, and metal augmentation. However, when bone loss of the distal femur is severe, the viability of these methods can be limited.In the setting of severe bone loss, endoprosthetic reconstruction (EPR) with a megaprosthesis has become increasingly popular for both malignant and non-neoplastic indications. The primary aim of this study was to determine the short-term prosthesis survivorship, as well as complications, for patients who presented with non-neoplastic disease indications for megaprosthesis distal femoral replacement (DFR) at a single institution. The secondary aim was to identify factors that influenced the outcome of DFR. Methods: A retrospective review was performed to identify patients who underwent megaprosthetic DFR surgery for a non-neoplastic indication, including native and preiprosthetic fractures, septic and aseptic nonunion, periprosthetic joint infection (PJI), and aseptic loosening or mechanical failure of a previous prosthesis. Information regarding complications, reoperations, demographics and comorbidities were recorded, excluding patients with less than 24 months follow-up. Reoperation for implant failure was used as the final endpoint for survivorship. Results: Seventy-five patients were identified. DFR survivorship was 86% at one year and 76% at five years. Patients who sustained a native fracture or had non-union demonstrated the highest survival rate at one and five years, (91%, 82% respectively) followed by patients with aseptic loosening or mechanical failure of previous implants, and then patients with PJI. A total of 36 (48 %) patients experienced at least one post-operative complication and 27 patients (36%) required at least one reoperation. Fracture, aseptic loosening, and PJI were complications more likely to require reoperation for prosthesis failure. Furthermore, patient demographics and comorbidities were not significant for predicting failure. Discussion: DFR is a viable surgical option for significant distal femoral bone loss with good short-term survivorship. There is a high overall complication rate, however the complication profile, as well as survivorship may vary based on the initial indication for DFR

Regional variation in angioplasty practice in the United States: A report from the Hirulog angioplasty study

Pla general de la font anomenada Homenatge al poble, ubicada a la plaça Molina. A la part superior de la font, a cada costat, hi ha un escut cisellat. Sota un d'aquests es troba la frase Gratitud al Ayuntamiento.Realitzada en pedra abans de 1874

Survivorship, complications, and outcomes following distal femoral arthroplasty for non-neoplastic indications.

AIMS: Endoprosthetic reconstruction with a distal femoral arthroplasty (DFA) can be used to treat distal femoral bone loss from oncological and non-oncological causes. This study reports the short-term implant survivorship, complications, and risk factors for patients who underwent DFA for non-neoplastic indications. METHODS: We performed a retrospective review of 75 patients from a single institution who underwent DFA for non-neoplastic indications, including aseptic loosening or mechanical failure of a previous prosthesis (n = 25), periprosthetic joint infection (PJI) (n = 23), and native or periprosthetic distal femur fracture or nonunion (n = 27). Patients with less than 24 months\u27 follow-up were excluded. We collected patient demographic data, complications, and reoperations. Reoperation for implant failure was used to calculate implant survivorship. RESULTS: Overall one- and five-year implant survivorship was 87% and 76%, respectively. By indication for DFA, mechanical failure had one- and five-year implant survivorship of 92% and 68%, PJI of 91% and 72%, and distal femur fracture/nonunion of 78% and 70% (p = 0.618). A total of 37 patients (49%) experienced complications and 27 patients (36%) required one or more reoperation. PJI (n = 16, 21%), aseptic loosening (n = 9, 12%), and wound complications (n = 8, 11%) were the most common complications. Component revision (n = 10, 13.3%) and single-stage exchange for PJI (n = 9, 12.0 %) were the most common reoperations. Only younger age was significantly associated with increased complications (mean 67 years (SD 9.1)) with complication vs 71 years (SD 9.9) without complication; p = 0.048). CONCLUSION: DFA is a viable option for distal femoral bone loss from a range of non-oncological causes, demonstrating acceptable short-term survivorship but with high overall complication rates

Systemwide Clinical Ultrasound Program Development: An Expert Consensus Model.

Clinical ultrasound (CUS) is integral to the practice of an increasing number of medical specialties. Guidelines are needed to ensure effective CUS utilization across health systems. Such guidelines should address all aspects of CUS within a hospital or health system. These include leadership, training, competency, credentialing, quality assurance and improvement, documentation, archiving, workflow, equipment, and infrastructure issues relating to communication and information technology. To meet this need, a group of CUS subject matter experts, who have been involved in institution- and/or systemwide clinical ultrasound (SWCUS) program development convened. The purpose of this paper was to create a model for SWCUS development and implementation

The Fate of Periprosthetic Joint Infection Following Megaprosthesis Reconstruction

Background: A megaprosthesis may be used for reconstruction in patients with massive bone loss or a periprosthetic fracture. Periprosthetic joint infection (PJI) may occur after a megaprosthesis reconstruction and may pose a major challenge. The outcomes of managing PJI in patients with a megaprosthesis is relatively unclear. The aim of this study was to investigate the clinical course and outcomes of PJI in patients with a megaprosthesis in place. Methods: From a total of 219 patients who underwent megaprosthesis replacement for non-oncologic conditions, 38 (17.4%) developed subsequent PJI. A retrospective review of the medical record was performed to ascertain the course of the PJI and treatment outcomes. Kaplan-Meier analysis was performed to evaluate the survival function, and the log-rank test was used to assess differences in outcome measures. Results: The surgical management of 33 patients with PJI included debridement, antibiotics, and implant retention (DAIR) (82%), consisting of DAIR with modular component exchange (19 patients) and DAIR without component exchange (8 patients); 2-stage exchange arthroplasty (9%); resection arthroplasty (6%); and a single-stage revision arthroplasty (3%). The Kaplan-Meier survivorship analysis demonstrated that the overall survival rate was 65.1% at 2 years. The mortality rate was 15%, with many patients undergoing salvage procedures including amputation (18%), arthrodesis (6%), and resection arthroplasty (6%). Conclusions: The rate of PJI after megaprosthesis reconstruction, 17% in this study, appears to be very high. The management of PJI in these patients is challenging, with 1 of 3 patients undergoing failed treatment. Despite the limited options available, DAIR seems to be an appropriate treatment strategy for some of these patients. Further data on a larger cohort are needed to assess the success of various surgical procedures and predictors of failure in this challenging patient population. Level of evidence: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence

Proximal tibial replacement in revision knee arthroplasty for non-oncologic indications.

Proximal tibial metaphyseal bone loss compromises the alignment and fixation of components during revision total knee arthroplasty. In massive, segmental defects with loss of collateral ligamentous support and lack of bone to support the use of prosthetic augments or metaphyseal cones or sleeves, a hinged proximal tibial replacement or a so-called megaprosthesis should be available. While proximal tibial replacement is the reconstructive method of choice in the setting of bone tumor resection, applications in non-oncologic joint arthroplasty are rare and may offer an opportunity for limb salvage in dire clinical scenarios with massive proximal tibial bone loss. This report reviews 6 cases of proximal tibial replacement

Thrombin-receptor antagonist vorapaxar in acute coronary syndromes

Background: Vorapaxar is a new oral protease-activated-receptor 1 (PAR-1) antagonist that inhibits thrombin-induced platelet activation. Methods: In this multinational, double-blind, randomized trial, we compared vorapaxar with placebo in 12,944 patients who had acute coronary syndromes without ST-segment elevation. The primary end point was a composite of death from cardiovascular causes, myocardial infarction, stroke, recurrent ischemia with rehospitalization, or urgent coronary revascularization. RESULTS: Follow-up in the trial was terminated early after a safety review. After a median follow-up of 502 days (interquartile range, 349 to 667), the primary end point occurred in 1031 of 6473 patients receiving vorapaxar versus 1102 of 6471 patients receiving placebo (Kaplan-Meier 2-year rate, 18.5% vs. 19.9%; hazard ratio, 0.92; 95% confidence interval [CI], 0.85 to 1.01; P = 0.07). A composite of death from cardiovascular causes, myocardial infarction, or stroke occurred in 822 patients in the vorapaxar group versus 910 in the placebo group (14.7% and 16.4%, respectively; hazard ratio, 0.89; 95% CI, 0.81 to 0.98; P = 0.02). Rates of moderate and severe bleeding were 7.2% in the vorapaxar group and 5.2% in the placebo group (hazard ratio, 1.35; 95% CI, 1.16 to 1.58; P<0.001). Intracranial hemorrhage rates were 1.1% and 0.2%, respectively (hazard ratio, 3.39; 95% CI, 1.78 to 6.45; P<0.001). Rates of nonhemorrhagic adverse events were similar in the two groups. Conclusions: In patients with acute coronary syndromes, the addition of vorapaxar to standard therapy did not significantly reduce the primary composite end point but significantly increased the risk of major bleeding, including intracranial hemorrhage. (Funded by Merck; TRACER ClinicalTrials.gov number, NCT00527943.

Milvexian for the Prevention of Venous Thromboembolism

Background: Factor XIa inhibitors for the prevention and treatment of venous and arterial thromboembolism may be more effective and result in less bleeding than conventional anticoagulants. Additional data are needed regarding the efficacy and safety of milvexian, an oral factor XIa inhibitor. Methods: In this parallel-group, phase 2 trial, we randomly assigned 1242 patients undergoing knee arthroplasty to receive one of seven postoperative regimens of milvexian (25 mg, 50 mg, 100 mg, or 200 mg twice daily or 25 mg, 50 mg, or 200 mg once daily) or enoxaparin (40 mg once daily). The primary efficacy outcome was venous thromboembolism (which was a composite of asymptomatic deep-vein thrombosis, confirmed symptomatic venous thromboembolism, or death from any cause). The principal safety outcome was bleeding. Results: Among the patients receiving milvexian twice daily, venous thromboembolism developed in 27 of 129 (21%) taking 25 mg, in 14 of 124 (11%) taking 50 mg, in 12 of 134 (9%) taking 100 mg, and in 10 of 131 (8%) taking 200 mg. Among those receiving milvexian once daily, venous thromboembolism developed in 7 of 28 (25%) taking 25 mg, in 30 of 127 (24%) taking 50 mg, and in 8 of 123 (7%) taking 200 mg, as compared with 54 of 252 patients (21%) taking enoxaparin. The dose-response relationship with twice-daily milvexian was significant (one-sided P&lt;0.001), and the 12% incidence of venous thromboembolism with twice-daily milvexian was significantly lower than the prespecified benchmark of 30% (one-sided P&lt;0.001). Bleeding of any severity occurred in 38 of 923 patients (4%) taking milvexian and in 12 of 296 patients (4%) taking enoxaparin; major or clinically relevant nonmajor bleeding occurred in 1% and 2%, respectively; and serious adverse events were reported in 2% and 4%, respectively. Conclusions: Postoperative factor XIa inhibition with oral milvexian in patients undergoing knee arthroplasty was effective for the prevention of venous thromboembolism and was associated with a low risk of bleeding. (Funded by Bristol Myers Squibb and Janssen Research and Development; AXIOMATIC-TKR ClinicalTrials.gov number, NCT03891524.)