The Brehm Precision knee ® - is there a different outcome based on gender?

Hintergrund Das menschliche Kniegelenk weist in der knöchernen Anatomie Unterschiede zwischen Männern und Frauen auf. Dennoch wird die Frage, ob diese anatomischen Unterschiede durch geschlechtsspezifisches Prothesendesign abgebildet werden müssen, oder ob neue Zwischengrößen und Größenverhältnisse ausreichend sind, kontrovers diskutiert. Ziel der Arbeit war eine Untersuchung der Ergebnisse nach Implantation des Brehm Präzisions Knies® mit mobiler Plattform im Hinblick auf geschlechtsspezifische Unterschiede. Material und Methoden Es wurden 48 Patienten (52 Kniegelenke; 16 Männer und 32 Frauen) nachuntersucht, bei denen zwischen Mai 2005 und Dezember 2006 in der Orthopädisch- Unfallchirurgischen Klinik im Krankenhauses Rummelsberg ein Brehm Präzisions Knie® mit mobiler Plattform, einem Prothesensystem für beide Geschlechter, implantiert worden war. Die Implantation erfolgte unter Erhalt des hinteren Kreuzbandes, Zementierung sowie ohne Patellarückflächenersatz. Alle Patienten wurden anhand des HSS Score, Knee Society Score, Bewegungsumfang (ROM), WOMAC Score und der Visuellen Analogskala (VAS) nachuntersucht; als radiologischer Parameter wurde die postoperative Achsausrichtung bestimmt. Zusätzlich wurden die präoperativen Werte des HSS Score, Knee Society Score, des ROM und der Achsausrichtung erhoben und so Differenzwerte ermittelt. Ergebnisse Es ließ sich kein signifikanter Unterschied zwischen beiden Geschlechtern bei postoperativen Werten sowie bei Differenzwerten für prä- und postoperative Parameter feststellen. Im HSS Score schnitten die Frauen prä- und postoperativ mit 50,0 [27-78] und 91,0 [63-98] Punkten besser ab als die Männer mit 47,0 [25-78] and 88,0 [67-96] Punkten. Ebenso erzielten die Frauen im KSS Score prä- und postoperativ mit 79,0 [20-137] und 174,0 [78-198] Punkten bessere Werte als die Männer mit 74,0 [36-139] and 168,0 [121-197] Punkten. Bei unterschiedlichem Range erzielten beide Gruppen im Bewegungsumfang 105° prä- und 110° postoperativ. Postoperativ gaben die Frauen auf der subjektiven VAS Skala mit 1,0 [0-9] mehr Schmerzen als die Männer mit 0,0 [0-4] an. Andererseits wies der WOMAC Score im Median bei den Männern mit 1,21 [0,2-2,33] höhere Werte auf als bei den Frauen mit 0,86 [0,0-6,58]. Von den 6 verschiedenen verfügbaren Femurgrößen wurden die Größen 3,4,5 und 6 verwendet, wobei bei den Frauen vor allem Größe 4 und bei den Männern vor allem Größe 5 implantiert wurde. Schlussfolgerungen Geschlechtsspezifische signifikante unterschiedliche Ergebnisse ließen sich in dieser Arbeit, basierend auf dem Brehm Präzisions Knie®, nicht feststellen. Die Verteilung der Femurgrößen in unserer Studie steht im Einklang mit dem in der Literatur berichteten Phänomen kleinerer Femora bei Frauen. Da das BPK als Knieprothese für beide Geschlechter konzipiert und in 6 verschiedenen Größen und Größenverhältnissen verfügbar ist, bildet es geschlechtsspezifische anatomische Unterscheide ausreichend ab.Background The anatomy of the bone of the human knee differs between women and men. However, the question as to whether these differences in anatomy have to be taken into account by female-specific prosthesis design or if new intermediate sizes and size ratios of preexistent prostheses systems are sufficient remains largely controversial. This paper aims to review the results of a retrospective study performed with the Brehm Präzisions Knie® (BPK) with mobile bearing and focuses on differences in outcome based on gender. Materials and Methods We retrospectively reviewed 48 patients (52 knees; 16 men and 32 women) with a mobile bearing BPK, a unisex prosthesis, which had been implanted between May 2005 and December 2006 in the Department of Orthopedic Surgery at the Krankenhaus Rummelsberg/Germany. Implantation was performed using cruciate retaining and implant cementing without patella-resurfacing techniques. All patients were evaluated using the HSS Score, Knee Society Score, Range of motion (ROM), WOMAC Score and Visual Analogue Scale (VAS); limb axis positioning was used as a radiologic parameter. We also obtained preoperative scores on HSS Score, Knee Society Score, ROM and the axis, creating differences for these parameters respectively. Results No significant difference could be determined between genders for postoperative parameters and difference between pre- and postoperative parameters between both groups. Women scored higher on HSS Score pre- and postoperatively with 50,0 [27-78] and 91,0 [63-98] points versus 47,0 [25-78] and 88,0 [67-96] points in the male group. On KSS Score, the female group scored higher pre- and postoperatively as well, with 79,0 [20-137] and 174,0 [78-198] points versus the male group with 74,0 [36-139] and 168,0 [121-197]. Despite a different range, both groups scored 105° pre- and 110° postoperatively on ROM. Postoperatively, women reported more pain than men on the subjective VAS scale, with scores of 1,0 [0-9] and 0,0 [0-4] respectively. Conversely, men scored higher on WOMAC Score compared to their female counterparts with 1,21 [0,2- 2,33] and 0,86 [0,0-6,58] respectively. Of the six different femur sizes, sizes 3, 4, 5 and 6 were used, with women using mostly size 4 and most men using size 5. Conclusions The results obtained in this study are based on implantation of the Brehm Präzisions Knie® and were not statistically significant. The distribution of femur sizes in our study reflects the phenomenon of smaller femora in females reported in literature. As the BPK system is a total knee prosthesis designed for both genders and is available in 6 different sizes and size ratios, it sufficiently reflects gender – specific anatomic differences in the knee

Ischaemic stroke in anticoagulated patients with atrial fibrillation.

Anticoagulation substantially reduces the risk of stroke in patients with atrial fibrillation (AF). However, recent studies have shown that up to 22%-36% of patients on anticoagulation will suffer an ischaemic stroke (IS). In this narrative review, we provide an overview of risk factors, mechanisms, management of acute IS and strategies for secondary prevention for patients with AF with stroke despite oral anticoagulation. For this paper, we reviewed available literature from important studies (randomised clinical trials, meta-analyses, reviews and case series) on patients with IS despite anticoagulation. We focused on recent studies that examined safety and efficacy of acute stroke treatments and evaluation and management strategies for secondary prevention. The literature review suggests that patients with AF with IS despite anticoagulation are a heterogeneous group with several possible mechanisms, which may include reduced or non-adherence to anticoagulation, competing non-cardioembolic stroke aetiologies or cardioembolic mechanisms separate from AF. The identification of one or more possible mechanisms of stroke despite anticoagulation may allow for a more targeted and individualised approach for secondary prevention. There are limited data to guide management in such patients, and strategies to prevent recurrent strokes include strict risk factor control and therapies targeting the most likely stroke mechanism. In cases where AF is suspected to be the culprit, clinical trials are needed to test the safety and efficacy of left atrial appendage occlusion plus anticoagulation versus continued anticoagulation alone

Intracerebral Hemorrhage with Intraventricular Extension—Getting the Prognosis Right Early

BackgroundEarly accurate outcome prognostication for patients with intracerebral hemorrhage (ICH) and accompanying intraventricular hemorrhage (IVH) is often challenging (1). Acute hydrocephalus often contributes to a poor clinical exam (2) and can portend significant morbidity and mortality (3). Accordingly, the inpatient neurologist may feel inclined to recommend limitations of care for an ICH patient admitted with a large IVH burden and poor exam.Case presentationWe present a patient with significant IVH and minimal ICH who deteriorated rapidly to coma after presentation. Despite this exam, an initially non-functioning diversion of cerebrospinal fluid (CSF) and temporary halt of further attempts of CSF diversion in the setting of an early “do not resuscitate order,” our patient gradually improved and, with supportive ICU care and rehabilitation, was able to communicate and ambulate with assistance at 12 weeks.ConclusionPatients with ICH with IVH do have the capacity to improve dramatically even with relatively conservative management. Unless previous limitations of care exist, we recommend that early judgments of prognosis for patients with ICH and/or IVH should be delayed for at least 72 h until the patient’s clinical trajectory over time is better understood

Intravenous Fibrinolysis for Central Retinal Artery Occlusion: A Cohort Study and Updated Patient-Level Meta-Analysis

BACKGROUND AND PURPOSE: Central retinal artery occlusion results in sudden, painless, usually permanent loss of vision in the affected eye. There is no proven, effective treatment to salvage visual acuity and a clear, unmet need for an effective therapy. In this work, we evaluated the efficacy of intravenous tissue-type plasminogen activator (IV alteplase) in a prospective cohort study and an updated systematic review and meta-analysis. METHODS: We enrolled consecutive patients with acute central retinal artery occlusion within 48 hours of symptoms onset and with a visual acuity of \u3c20/200 from January 2009 until May 2019. The primary outcomes were safety and functional visual acuity recovery. We compared rates of visual recovery between those treated with alteplase within 4.5 hours of symptom onset to those who did not receive alteplase (including an analysis restricted to untreated patients presenting within the window for treatment). We incorporated these results into an updated systematic review and patient-level meta-analysis. RESULTS: We enrolled 112 patients, of whom 25 (22.3% of the cohort) were treated with IV alteplase. One patient had an asymptomatic intracerebral hemorrhage after IV alteplase treatment. Forty-four percent of alteplase-treated patients had recovery of visual acuity when treated within 4.5 hours versus 13.1% of those not treated with alteplase (P=0.003) and 11.6% of those presenting within 4 hours who did not receive alteplase (P=0.03). Our updated patient-level meta-analysis of 238 patients included 67 patients treated with alteplase within 4.5 hours since time last known well with a recovery rate of 37.3%. This favorably compares with a 17.7% recovery rate in those without treatment. In linear regression, earlier treatment correlated with a higher rate of visual recovery (P=0.01). CONCLUSIONS: This study showed that the administration of intravenous alteplase within 4.5 hours of symptom onset is associated with a higher likelihood of a favorable visual outcome for acute central retinal artery occlusion. Our results strongly support proceeding to a randomized, placebo-controlled clinical trial

Direct Oral Anticoagulants Versus Warfarin in the Treatment of Cerebral Venous Thrombosis (ACTION-CVT): A Multicenter International Study.

BACKGROUND A small randomized controlled trial suggested that dabigatran may be as effective as warfarin in the treatment of cerebral venous thrombosis (CVT). We aimed to compare direct oral anticoagulants (DOACs) to warfarin in a real-world CVT cohort. METHODS This multicenter international retrospective study (United States, Europe, New Zealand) included consecutive patients with CVT treated with oral anticoagulation from January 2015 to December 2020. We abstracted demographics and CVT risk factors, hypercoagulable labs, baseline imaging data, and clinical and radiological outcomes from medical records. We used adjusted inverse probability of treatment weighted Cox-regression models to compare recurrent cerebral or systemic venous thrombosis, death, and major hemorrhage in patients treated with warfarin versus DOACs. We performed adjusted inverse probability of treatment weighted logistic regression to compare recanalization rates on follow-up imaging across the 2 treatments groups. RESULTS Among 1025 CVT patients across 27 centers, 845 patients met our inclusion criteria. Mean age was 44.8 years, 64.7% were women; 33.0% received DOAC only, 51.8% received warfarin only, and 15.1% received both treatments at different times. During a median follow-up of 345 (interquartile range, 140-720) days, there were 5.68 recurrent venous thrombosis, 3.77 major hemorrhages, and 1.84 deaths per 100 patient-years. Among 525 patients who met recanalization analysis inclusion criteria, 36.6% had complete, 48.2% had partial, and 15.2% had no recanalization. When compared with warfarin, DOAC treatment was associated with similar risk of recurrent venous thrombosis (aHR, 0.94 [95% CI, 0.51-1.73]; P=0.84), death (aHR, 0.78 [95% CI, 0.22-2.76]; P=0.70), and rate of partial/complete recanalization (aOR, 0.92 [95% CI, 0.48-1.73]; P=0.79), but a lower risk of major hemorrhage (aHR, 0.35 [95% CI, 0.15-0.82]; P=0.02). CONCLUSIONS In patients with CVT, treatment with DOACs was associated with similar clinical and radiographic outcomes and favorable safety profile when compared with warfarin treatment. Our findings need confirmation by large prospective or randomized studies

Predictors of Recurrent Venous Thrombosis After Cerebral Venous Thrombosis: Analysis of the ACTION-CVT Study.

BACKGROUND and Purpose: Cerebral venous thrombosis (CVT) is a rare cause of stroke carrying a nearly 4% risk of recurrence after 1 year. There is limited data on predictors of recurrent venous thrombosis in patients with CVT. In this study, we aim to identify those predictors. METHODS This is a secondary analysis of the ACTION-CVT study which is a multi-center international study of consecutive patients hospitalized with a diagnosis of CVT over a 6-year period. Patients with cancer associated CVT, CVT during pregnancy, or CVT in the setting of known antiphospholipid antibody syndrome were excluded per the ACTION-CVT protocol. The study outcome was recurrent venous thrombosis defined as recurrent venous thromboembolism (VTE) or de-novo CVT. We compared characteristics between patients with vs. without recurrent venous thrombosis during follow-up and performed adjusted Cox regression analyses to determine important predictors of recurrent venous thrombosis. RESULTS 947 patients were included with a mean age was 45.2 years, 63.9% were women, and 83.6% had at least 3-months of follow-up. During a median follow-up of 308 (IQR 120-700) days, there were 5.05 recurrent venous thromboses (37 VTE and 24 de-novo CVT) per 100 patient-years. Predictors of recurrent venous thrombosis were Black race (adjusted HR 2.13, 95% CI 1.14-3.98, p = 0.018), prior history of VTE (aHR 3.40, 95% CI 1.80-6.42, p < 0.001) and the presence of one or more positive antiphospholipid antibodies (aHR 3.85, 95% CI 1.97-7.50, p < 0.001). Sensitivity analyses including events only occurring on oral anticoagulation yielded similar findings. CONCLUSION Black race, history of VTE, and the presence of one or more antiphospholipid antibodies are associated with recurrent venous thrombosis among patients with CVT. Future studies are needed to validate our findings to better understand mechanisms and treatment strategies in patients with CVT

Intravenous Thrombolysis in Patients With Ischemic Stroke and Recent Ingestion of Direct Oral Anticoagulants

Importance: International guidelines recommend avoiding intravenous thrombolysis (IVT) in patients with ischemic stroke who have a recent intake of a direct oral anticoagulant (DOAC). Objective: To determine the risk of symptomatic intracranial hemorrhage (sICH) associated with use of IVT in patients with recent DOAC ingestion. Design, Setting, and Participants: This international, multicenter, retrospective cohort study included 64 primary and comprehensive stroke centers across Europe, Asia, Australia, and New Zealand. Consecutive adult patients with ischemic stroke who received IVT (both with and without thrombectomy) were included. Patients whose last known DOAC ingestion was more than 48 hours before stroke onset were excluded. A total of 832 patients with recent DOAC use were compared with 32375 controls without recent DOAC use. Data were collected from January 2008 to December 2021. Exposures: Prior DOAC therapy (confirmed last ingestion within 48 hours prior to IVT) compared with no prior oral anticoagulation. Main Outcomes and Measures: The main outcome was sICH within 36 hours after IVT, defined as worsening of at least 4 points on the National Institutes of Health Stroke Scale and attributed to radiologically evident intracranial hemorrhage. Outcomes were compared according to different selection strategies (DOAC-level measurements, DOAC reversal treatment, IVT with neither DOAC-level measurement nor idarucizumab). The association of sICH with DOAC plasma levels and very recent ingestions was explored in sensitivity analyses. Results: Of 33207 included patients, 14458 (43.5%) were female, and the median (IQR) age was 73 (62-80) years. The median (IQR) National Institutes of Health Stroke Scale score was 9 (5-16). Of the 832 patients taking DOAC, 252 (30.3%) received DOAC reversal before IVT (all idarucizumab), 225 (27.0%) had DOAC-level measurements, and 355 (42.7%) received IVT without measuring DOAC plasma levels or reversal treatment. The unadjusted rate of sICH was 2.5% (95% CI, 1.6-3.8) in patients taking DOACs compared with 4.1% (95% CI, 3.9-4.4) in control patients using no anticoagulants. Recent DOAC ingestion was associated with lower odds of sICH after IVT compared with no anticoagulation (adjusted odds ratio, 0.57; 95% CI, 0.36-0.92). This finding was consistent among the different selection strategies and in sensitivity analyses of patients with detectable plasma levels or very recent ingestion. Conclusions and Relevance: In this study, there was insufficient evidence of excess harm associated with off-label IVT in selected patients after ischemic stroke with recent DOAC ingestion.

Intravenous Thrombolysis in Patients With Ischemic Stroke and Recent Ingestion of Direct Oral Anticoagulants

Importance International guidelines recommend avoiding intravenous thrombolysis (IVT) in patients with ischemic stroke who have a recent intake of a direct oral anticoagulant (DOAC). Objective To determine the risk of symptomatic intracranial hemorrhage (sICH) associated with use of IVT in patients with recent DOAC ingestion. Design, Setting, and Participants This international, multicenter, retrospective cohort study included 64 primary and comprehensive stroke centers across Europe, Asia, Australia, and New Zealand. Consecutive adult patients with ischemic stroke who received IVT (both with and without thrombectomy) were included. Patients whose last known DOAC ingestion was more than 48 hours before stroke onset were excluded. A total of 832 patients with recent DOAC use were compared with 32 375 controls without recent DOAC use. Data were collected from January 2008 to December 2021. Exposures Prior DOAC therapy (confirmed last ingestion within 48 hours prior to IVT) compared with no prior oral anticoagulation. Main Outcomes and Measures The main outcome was sICH within 36 hours after IVT, defined as worsening of at least 4 points on the National Institutes of Health Stroke Scale and attributed to radiologically evident intracranial hemorrhage. Outcomes were compared according to different selection strategies (DOAC-level measurements, DOAC reversal treatment, IVT with neither DOAC-level measurement nor idarucizumab). The association of sICH with DOAC plasma levels and very recent ingestions was explored in sensitivity analyses. Results Of 33 207 included patients, 14 458 (43.5%) were female, and the median (IQR) age was 73 (62-80) years. The median (IQR) National Institutes of Health Stroke Scale score was 9 (5-16). Of the 832 patients taking DOAC, 252 (30.3%) received DOAC reversal before IVT (all idarucizumab), 225 (27.0%) had DOAC-level measurements, and 355 (42.7%) received IVT without measuring DOAC plasma levels or reversal treatment. The unadjusted rate of sICH was 2.5% (95% CI, 1.6-3.8) in patients taking DOACs compared with 4.1% (95% CI, 3.9-4.4) in control patients using no anticoagulants. Recent DOAC ingestion was associated with lower odds of sICH after IVT compared with no anticoagulation (adjusted odds ratio, 0.57; 95% CI, 0.36-0.92). This finding was consistent among the different selection strategies and in sensitivity analyses of patients with detectable plasma levels or very recent ingestion. Conclusions and Relevance In this study, there was insufficient evidence of excess harm associated with off-label IVT in selected patients after ischemic stroke with recent DOAC ingestion

Risk factors for intracerebral hemorrhage in patients with atrial fibrillation on NOACs for stroke prevention

Background and Purpose: Clinical trials on stroke prevention in patients with atrial fibrillation have consistently shown clinical benefit from either warfarin or non–vitamin K antagonist oral anticoagulants (NOACs). NOAC-treated patients have consistently reported to be at lower risk for intracerebral hemorrhage (ICH) than warfarin-treated patients. The aims of this prospective, multicenter, multinational, unmatched, case-control study were (1) to investigate for risk factors that could predict ICH occurring in patients with atrial fibrillation during NOAC treatment and (2) to evaluate the role of CHA2DS2-VASc and HAS-BLED scores in the same setting. Methods: Cases were consecutive patients with atrial fibrillation who had ICH during NOAC treatment. Controls were consecutive patients with atrial fibrillation who did not have ICH during NOAC treatment. As within the CHA2DS2-VASc and HAS-BLED scores there are some risk factors in common, several multivariable logistic regression models were performed to identify independent prespecified predictors for ICH events. Results: Four hundred nineteen cases (mean age, 78.8±8.1 years) and 1526 controls (mean age, 76.0±10.3 years) were included in the study. From the different models performed, independent predictors of ICH were increasing age, concomitant use of antiplatelet agents, active malignancy, high risk of fall, hyperlipidemia, low clearance of creatinine, peripheral artery disease, and white matter changes. Low doses of NOACs (given according to label or not) and congestive heart failure were inversely associated with the risk of ICH. HAS-BLED and CHA2DS2-VASc scores performed poorly in predicting ICH with areas under the curves of 0.496 (95% CI, 0.468-0.525) and 0.530 (95% CI, 0.500-0.560), respectively. Conclusions: Several risk factors were associated to ICH in patients treated with NOACs for stroke prevention but not HAS-BLED and CHA2DS2-VASc scores