Management of Traumatic Brain Injury in Patients with DOAC Therapy-Are the "New" Oral Anticoagulants Really Safer?

(1) Background: In recent years, "new" direct oral anticoagulants (DOAC) have gradually replaced other antithrombotic therapies. The international literature agrees on the increased mortality for traumatic brain injury (TBI) patients using vitamin K antagonists (VKA), but thus far, there are insufficient data on the influence of DOAC on the outcome of TBI. (2) Methods: We retrospectively analyzed data from all patients who presented with head trauma using antithrombotic therapy. Outcome parameters were the presence of pathologies on the initial CT, occurrence of delayed intracranial hemorrhage, surgical intervention, and death. (3) Results: In total, data of 1169 patients were reviewed. Of those, 1084 (92.7%) had a mild TBI, 67 (5.7%) moderate TBI, and 17 (1.5%) severe TBI. In total, 456 patients (39%) used DOAC and 713 patients (61%) used VKA, antiplatelet therapy, or prophylactic doses of low molecular weight heparin at the time of trauma. The groups showed no significant differences in age, injury mechanisms, or GCS at presentation. Overall, the initial cranial CT showed pathologies in 85 patients (7.3%). Twenty-five patients with head trauma and DOAC therapy had pathological findings on CT (5.5%), 11 patients with VKA (4.8%), and 48 patients with antiplatelet therapy (10.6%). There was a statistically significant difference in occurrence of CT pathologies between DOAC alone compared to acetylsalicylic acid (4.9 vs. 10.5%, p = 0.04). Delayed intracranial hemorrhage after an initially negative CT during in-hospital observation occurred in one patient (0.2%) in the DOAC group, two patients (0.9%) in the VKA group, and four patients (0.9%) in the antiplatelet group without statistical significance. Head trauma related surgery was performed in three patients (0.7%) in the DOAC group, two patients (0.9%) in the VKA group, and six patients (1.3%) in the antiplatelet group without statistical significance. Death due to head trauma occurred in four patients (0.9%) of the DOAC group compared to one patient (0.4%) of the VKA group and five patients (1.1%) of the antiplatelet group without statistical significance. (4) Conclusions: Our data suggest a comparable risk of pathological CT findings, delayed intracranial hemorrhage, surgical interventions, and death after blunt head trauma for patients with DOAC compared to VKA, but a lower risk for pathological CT findings compared to platelet inhibitors. As VKA are known to increase mortality, our data suggest that similar caution should be used when treating patients with head trauma and DOAC, but the overall numbers of serious or severe courses after simple falls remain low. We recommend routine CT for all head trauma patients with antithrombotic therapy but the role of in-hospital observation for patients with mild TBI remains a matter of debate.

Relationship between the Thickness of the Coracoid Process and Latarjet Graft Positioning-An Anatomical Study on 70 Embalmed Scapulae.

BACKGROUND: The Latarjet procedure is a popular technique with the aim of the reconstruction of glenoid cavity bone defects in patients with chronic anterior shoulder instability. Studies have shown that the Congruent arc Latarjet procedure is better able to reconstruct larger defects than the Classic Latarjet, but there is a lack of information on the limitations of both methods. METHODS: The dimensions of the glenoid width and the native coracoid process of two groups with 35 Formol-Carbol embalmed scapulae each were measured using a digital caliper. The relationship between the coracoid graft and the anterior-posterior diameter of the glenoid cavity was calculated to determine the maximum defect size of the glenoid cavity width, which can be treated by both Latarjet techniques. RESULTS: The average restorable defect size of the anterior segment of the glenoid cavity was 28.4% ± 4.6% (range 19.2%-38.8%) in the Classic Latarjet group, and 45.6% ± 5.2% (range 35.7%-57.1%) in the Congruent arc Latarjet group. Based on our results, the feasibility of the Classic Latarjet procedure to reconstitute the anatomical width of the glenoid cavity was 86% in a 25% bone loss scenario, and only 40% in a 30% bone loss scenario. CONCLUSION: Based on our results we are unable to define a clear threshold for the optimal Latarjet graft position. In glenoid cavity defects <20%, the Classic Latarjet technique usually provides enough bone stock for anatomical reconstruction. Defects ≥35% of the glenoid cavity width should only be treated with a coracoid graft in the Congruent arc position. In the critical area between 20% and 35% of bone loss, we suggest the preoperative assessment of coracoid dimensions, based on which the graft position can be planned to restore the anatomical anterior-posterior diameter of the glenoid cavity.

Preserving the radial head in comminuted Mason type III fractures without fixation to the radial shaft: a mid-term clinical and radiographic follow-up study.

BACKGROUND: The treatment of multifragment Mason type III fractures is challenging. Open reduction-internal fixation (ORIF), radial head arthroplasty, and in some cases, even radial head resection are the current options; however, each of these treatment methods is associated with characteristic benefits and complications. We present our experience with a radial head salvage procedure in comminuted radial head fractures irrespective of concomitant injuries, which are not accompanied by typical ORIF-related complications. METHODS: The first group comprised 29 patients with multifragment Mason type III fractures treated surgically with biological radial head spacers (group S). The fragments were reduced and fixated in an extracorporeal manner, and the reconstructed radial head was placed in its anatomic position without fixation to the shaft. The second group comprised 12 patients treated with conventional ORIF using mini-fragment plates (group P). RESULTS: Thirty patients were enrolled to undergo clinical and radiographic follow-up at an average of 76 months (range, 12-152 months). In group S, nonunion at the head-neck junction developed in 70% of the cases; however, the overall Mayo Elbow Performance Index averaged 94.8, which was superior to the average Mayo Elbow Performance Index of 83.1 in group P. Radiographic evaluation showed development of osteoarthritic changes in 75% of patients in group S and 62.5% in group P. None of the patients had wrist-joint pain. CONCLUSIONS: Preserving the native radial head in comminuted Mason type III fractures without fixation to the radial shaft is a reliable option. Excellent functional results can be expected; however, the development of osteoarthritis cannot be impeded.

Club cell protein 16 and cytokeratin fragment 21-1 as early predictors of pulmonary complications in polytraumatized patients with severe chest trauma.

BACKGROUND: Acute respiratory distress syndrome (ARDS) and pneumonia have a great impact on the treatment regimen of polytraumatized patients with severe chest trauma. The objective of our study was to determine whether biomarker levels assessed shortly after multiple trauma may predict the occurrence of these conditions. METHODS AND FINDINGS: Our patient population included 71 men and 30 women (mean age, 40.3 ± 15.8 years) with an Injury Severity Score that ranged from 17 to 59 and an Abbreviated Injury Scale Thorax of at least 3. They were admitted to our level I trauma center within one post-traumatic hour and survived for at least 24 hours after the trauma occurred. Thirty-five patients developed ARDS, 30 patients pneumonia and 21 patients both. Five individuals died during hospitalization. The levels of five selected biomarkers, which were identified by a literature search, were assessed at admission (initial levels) and on day 2 after trauma. We performed comparisons of medians, logistic regression analyses and receiver operating characteristic analyses for initial and day-2 levels of each biomarker. With regard to ARDS, initial levels of cytokeratin fragment 21-1, the soluble fragment of cytokeratin 19 (CYFRA21-1) and of the club cell protein 16 (CC16) provided significant results in each statistical analysis. With regard to pneumonia, each statistical analysis supplied significant results for both initial and day-2 levels of CYFRA21-1 and CC16. Consistently, initial CYFRA21-1 levels were identified as the most promising predictor of ARDS, whereas day-2 CC16 levels have to be considered as most appropriate for predicting pneumonia. CONCLUSIONS: CYFRA21-1 levels exceeding cut-off value of 1.85 ng/ml and 2.49 ng/ml in the serum shortly after multiple injury occurred may identify polytraumatized patients at risk for ARDS and pneumonia, respectively. However, CC16 levels exceeding 30.51 ng/ml on day 2 may allow a firmer diagnosis for the development of pneumonia.

Risk factors for humeral head necrosis and non-union after plating in proximal humeral fractures.

AIM: The aim of this study was to evaluate risk factors for the development of humeral head necrosis and non-union after proximal humeral fractures-in particular, general risk factors that exist independent of fracture type. MATERIALS AND METHODS: This study included patients (n=154) treated for proximal humeral fracture by means of open reduction and internal fixation (ORIF) using the Philos plate at a single level I trauma centre between January 2005 and December 2013. Follow-up monitoring included radiographic examination before hospital discharge, and again at 6 weeks, 12 weeks, and 6 months after surgery. At a minimum follow-up time of 6 months, radiographs taken in the anteroposterior and axial projection were evaluated in regard to the development of humeral head necrosis, non-union, and secondary screw cut out. RESULTS: A total of 154 patients (61 males, 93 females) were available for radiological checkup. Mean age was 55.8 years (range: 19-91 years). There were statistically significant correlations between the development of avascular necrosis (AVN) and fracture type, non-union and smoking, and screw cut out - as well as overall complication rate - and age. The time to surgery did not influence the risk for AVN or non-union, independent of fracture type. In this study population, the risk of developing non-union after ORIF was 3.9-fold higher in heavy smokers (i.e., >20 cigarettes per day). The risk for screw cut out was 4.1-fold higher in patients over 60 years of age, and the overall risk for complications was 3.3-fold higher. CONCLUSION: The older the patient, the more carefully one must consider the decision between conservative and operative treatments. If surgical treatment is performed, screw length should be selected depending on the patient's age. Heavy smokers must be informed preoperatively of the increased risk for bony non-union after ORIF.

The Difference between Growth Factor Expression after Single and Multiple Fractures: Preliminary Results in Human Fracture Healing.

OBJECTIVES: Circulating levels of VEGF-A (Vascular Endothelia Growth Factor-A), TGF-ß1 (Transforming Growth Factor-beta 1), and M-CSF (Macrophage-Colony Stimulating Factor) were found to be predictors of bone healing and therefore prognostic criteria of delayed bone healing or nonunion. The aim of this study was to evaluate a potential rise of these markers in patients with multiple fractures of long bones compared to patients with single fractured long bone. METHODS: 92 patients were included in the study and finally after excluding all female patients 45 male patients were left for final analysis and divided into the single or multiple fracture group. TGF-ß1, M-CSF, and VEGF-A serum levels were analysed over a time period of two weeks. RESULTS: MCSF serum concentrations were higher in the group with multiple fractures as also TGF-ß1 serum concentrations were at one and two weeks after trauma. No statistically significant difference was observed in the VEGF-A serum concentrations of both groups at either measurement point. CONCLUSION: We did observe a correlation between the quantity of the M-CSF and TGF-ß1 expressions in serum and the number of fractured bones; surprisingly there was no statistically significant difference in the serum levels between patients with single and multiple fractures of long bones.

Limb salvage and functional outcomes among patients with traumatic popliteal artery injury: a review of 64 cases.

BACKGROUND: Traumatic popliteal arterial injury carries the greatest risk of limb loss among all peripheral vascular injuries and is associated with high levels of morbidity and worse functional outcomes. The purpose of this study is to analyse the functional outcome among patients with popliteal artery injury (PAI) due to blunt and penetrating trauma and identify influencing factors. METHODS: We critically reviewed 64 cases of PAI due to blunt and penetrating trauma treated at our institution over a 20-year period. We evaluated the influence of parameters, such as patient demographics, injury mechanism, initial ISS and performed interventions, on limb amputation rates and functional outcomes. Functional outcome was examined within the 12-months follow-up using the Functional Independence Measure (FIM) score for feeding, expression and locomotion. FIM scores for each category ranged from 1 (full assistance required) to 4 (fully independent), with a maximum total FIM score of 12 representing full independence. RESULTS: The mechanism of injury was blunt in 55 % and penetrating in 45 % of the patients. The overall amputation rate in our series was 28 %. Out of these, 83.3 % of all performed amputations in our series were due to blunt trauma and 88.6 % of all blunt trauma patients were severely injured (ISS > 9) or polytraumatized (ISS > 15). Blunt mechanism of injury has also shown a negative effect on the functional outcome. Analysis of the 1-year clinical follow-up showed that 30 patients (65.3 %) returned to their normal activity level within 1 year after trauma. A total of 16 patients (34.7 %) were recorded to have limited activity levels, 76.5 % of them sustained a blunt trauma. Using the FIM score to quantify the level of disability, we detected significantly worse results in both FIM total (8.8 vs. 10.4) and FIM locomotion score (3.1 vs. 2.7) following blunt trauma. CONCLUSION: The main findings of the present study were that PAI due to blunt trauma is associated with a high percentage of severely injured or even polytraumatized patients. Amputation rates following blunt trauma were significantly higher compared to penetrating trauma. Functional independence measurement, assessed 12 months after injury, also showed significantly worse results in both FIM total and FIM locomotion score after blunt trauma. Other factors that seem to have a negative influence on the outcome in terms of amputation rates after PAI are patient's age, presence of associated injuries and prolonged lower extremity ischemia.

Is sonic Hedgehog involved in human fracture healing? --a prospective study on local and systemic concentrations of SHH.

INTRODUCTION: Sonic Hedgehog (SHH) is a new signalling pathway in bone repair. Evidence exist that SHH pathway plays a significant role in vasculogenesis and limb development during embryogenesis. Some in vitro and animal studies has already proven its potential for bone regeneration. However, no data on the role of SHH in the human fracture healing have been published so far. METHODS: Seventy-five patients with long bone fractures were included into the study and divided in 2 groups. First group contained 69 patients with normal fracture healing. Four patients with impaired fracture healing formed the second group. 34 volunteers donated blood samples as control. Serum samples were collected over a period of 1 year following a standardized time schedule. In addition, SHH levels were measured in fracture haematoma and serum of 16 patients with bone fractures. RESULTS: Fracture haematoma and patients serum both contained lower SHH concentrations compared to control serum. The comparison between the patients' serum SHH level and the control serum revealed lower levels for the patients at all measurement time points. Significantly lower concentrations were observed at weeks 1 and 2 after fracture. SHH levels were slightly decreased in patients with impaired fracture healing without statistical significance. CONCLUSION: This is the first study to report local and systemic concentration of SHH in human fracture healing and SHH serum levels in healthy adults. A significant reduction of the SHH levels during the inflammatory phase of fracture healing was found. SHH concentrations in fracture haematoma and serum were lower than the concentration in control serum for the rest of the healing period. Our findings indicate that there is no relevant involvement of SHH in human fracture healing. Fracture repair process seem to reduce the SHH level in human. Further studies are definitely needed to clarify the underlying mechanisms.

Are OPG and RANKL involved in human fracture healing?

Human fracture healing is a complex interaction of several cytokines that regulate osteoblast and osteoclast activity. By monitoring OPG (osteoprotegerin) and sRANKL we aimed to possibly predict normal or impaired fracture healing. In 64 patients with a fracture of a long bone serum level of sRANKL and OPG were evaluated with respect to bony union (n=57) or pseudarthrosis (n=7). Measurements were carried out at admission and at 1, 2, 4, 6, 8, 12, 24, and 48 weeks after the injury. Patients' serum levels were compared to 33 healthy controls. Fracture hematoma contained significantly higher sRANKL and OPG concentrations compared to patients serum (p=0.005, p=0.028). OPG level in fracture hematoma was higher compared to the unions serum level (p=0.028). sRANKL was decreased in unions during the observation period. In non-unions sRANKL and OPG levels showed a variable course, with no statistical significance. This is the first study to document the course of OPG and sRANKL in normal and delayed human fracture healing emphasizing its local and systemic involvement. We provide evidence of strongly enhanced OPG levels in patients with a long bone fracture compared to healthy controls. Further, levels of free sRANKL were decreased during regular fracture repair.

The modified Harrington procedure for metastatic peri-acetabular bone destruction.

PURPOSE: We describe the outcome in a series of patients treated for metastatic peri-actetabular and iliac bone destruction using a modified technique of Harrington's procedure. METHODS: Between 2006 and 2012, nine patients with a mean age of 62.2 years (42-75 years) were treated using a modified Harrington technique. Thereby, total hip replacement implants augmented by two to three threaded pins and cement were used to restore bony continuity of the pelvis and to achieve a stable construction allowing immediate full-weight bearing mobilisation. RESULTS: Acetabular destruction was graded according to Harrington's classification of peri-acetabular metastatic destruction, as class IV in one case, class III in six, and class II in two cases. The pre-operative ASA score ranged from II-IV. There were no intra-operative deaths or major complications such as excessive haemorrhage, deep infections, lesions of the femoral nerve, loss of fixation, or dislocations at final follow-up. Eight patients achieved an improvement of their functional status postoperatively. One reconstruction required revision and four patients died due to their underlying disease ten to 36 months after surgery. CONCLUSION: We found this technique an effective, reproducible, and long-lasting method to relieve pain and improve or restore function in patients with destructive metastatic lesions of the peri-acetabular bone and the iliac wing. Although we performed surgery even in severely ill patients with extended, generalised metastatic disease we had no intra- or postoperative death and observed no major complications.