Factor Xa/thrombin inhibitors(Boehringer Ingelheim)

Chronic pain is cumbersome, difficult to treat and a growing and costly problem in modern medical care. Spinal cord stimulation (SCS) has proven to be an effective technique for pain mitigation in many cases. Despite being generally safe, the procedure carries increased risks for patients on anti-coagulant medication due to the catheter placement in the epidural space inside the spinal canal. Since these medical conditions are mainly prevalent in the elderly, among which chronic pain is also particularly common and problematic, a large group of patients are nowadays potentially excluded from the benefits of the spinal cord stimulation. Furthermore, the occurrence of SCS catheter dislocation adds to these challenges. In this paper, we present a novel multi-electrode implant platform (SNAP, safe neuromodulation against pain) that does not need entry into the vulnerable epidural space. This technique aims to extend pain mitigation benefits to patients currently ineligible for traditional spinal cord implants. Moreover, the implant is rigidly locked onto the vertebral bone, has the potential to reduce the risk of migration. As a first step, the feasibility of stimulating the spinal cord electrically using only the SNAP electrodes located outside the epidural space, has been tested using finite element method (FEM) computer simulations, assessing the implant's ability to selectively stimulate the dorsal column fibers without the undesired stimulation of the muscles in the back. Furthermore, in-vitro experiments have been performed to test the feasibility of the wireless energy transfer method. The FEM simulations conducted in this paper show that a low-frequency current of 6.30 mA and 1.26 mA from the primary and the secondary SNAP electrodes, respectively, gives rise to a selective stimulation of the dorsal column fibers. The in-vitro experiments confirm the feasibility of sufficient wireless energy transfer. We presented a first proof of concept for a new method of safe neuromodulation against pain, focussing on the electric aspects of the method. Our preliminary results suggest that this new approach may potentially overcome some limitations associated with standard SCS.

Fewer than 20 % of traumatic brain injury (TBI) cases with traumatic intracranial hemorrhage (ICH) result in clinical deterioration. The Brain Injury Guideline (BIG) criteria were published in 2014 and categorize patients with TBI into three risk groups (BIG 1, 2, and 3) based on CT scan findings, neurological examination, anti-coagulant/platelet medications, and intoxication. Early data is promising, suggesting no instances of neurosurgical intervention or death in the low-risk BIG1 category within 30 days. We sought to externally validate the BIG criteria and identify patients with TBI at low risk of clinical deterioration. We hypothesized that patients meeting the BIG1 low risk criteria have less than a 1 % risk of death or neurosurgical intervention.

We performed a retrospective cohort study of a level 1 trauma center's trauma registry records from 2011 to 2022 to identify patients with head trauma. We abstracted demographics, injury characteristics, clinical course, CT imaging results, and outcomes, and we categorized patients according to the BIG criteria. The Clopper-Pearson Exact method was used to estimate outcome frequency with confidence intervals. The primary outcome was death or neurosurgical intervention within 30 days. Secondary outcomes included progression on repeat head CT (RHCT), ICU admission with neurocritical care intervention, and TBI-related hospital readmission within 30 days.

A total of 1714 patients with TBI with ICH were identified from the trauma registry. 325 patients were excluded due to missing data, pregnancy, incarceration, polytrauma, or GCS < 13, leaving 1389 for analysis. 193 patients (13.9 %) were classified as BIG1. No patients classified as BIG1 experienced the primary outcome measures of death or neurosurgical intervention (95 % confidence interval [CI]: 0 %-1.9 %). The number of patients who experienced the secondary outcome measures of progression on RHCT, ICU admission with neurocritical care intervention, or TBI-related hospital readmission within 30 days were 9 (4.7 %, 95 % CI: 2.2 %-8.7 %), 1 (0.5 %, 95 % CI: 0 %-2.9 %), and 4 (2.1 %, 95 % CI: 0.6 %-5.2 %), respectively.

BIG1 criteria identified a low-risk subset of patients with TBI with ICH. However, an upper 95 % CI of 1.9 % does not exclude the risk of neurologic deterioration being <1 %. Validation of these criteria in larger cohorts is warranted.