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.

Delayed Intracranial Hemorrhage in Patients with Head Trauma and Antithrombotic Therapy.

BACKGROUND: Delayed intracranial hemorrhage can occur up to several weeks after head trauma and was reported more frequently in patients with antithrombotic therapy. Due to the risk of delayed intracranial hemorrhage, some hospitals follow extensive observation and cranial computed tomography (CT) protocols for patients with head trauma, while others discharge asymptomatic patients after negative CT. METHODS: We retrospectively analyzed data on patients with head trauma and antithrombotic therapy without pathologies on their initial CT. During the observation period, we followed a protocol of routine repeat CT before discharge for patients using vitamin K antagonists, clopidogrel or direct oral anticoagulants. RESULTS: 793 patients fulfilled the inclusion criteria. Acetylsalicylic acid (ASA) was the most common antithrombotic therapy (46.4%), followed by vitamin K antagonists (VKA) (32.2%) and Clopidogrel (10.8%). We observed 11 delayed hemorrhages (1.2%) in total. The group of 390 patients receiving routine repeat CT showed nine delayed hemorrhages (2.3%). VKA were used in 6 of these 11 patients. One patient needed an urgent decompressive craniectomy while the other patients were discharged after an extended observation period. The patient requiring surgical intervention due to delayed hemorrhage showed neurological deterioration during the observation period. CONCLUSIONS: Routine repeat CT scans without neurological deterioration are not necessary if patients are observed in a clinical setting. Patients using ASA as single antithrombotic therapy do not require in-hospital observation after a negative CT scan.

Conventional versus rapid-deployment aortic valve replacement: a single-centre comparison between the Edwards Magna valve and its rapid-deployment successor.

OBJECTIVES: Sutureless and rapid-deployment valves were recently introduced into clinical practice. The Edwards INTUITY valve system is a combination of the Edwards Magna pericardial valve and a subvalvular stent-frame to enable rapid deployment. We performed a parallel cohort study for comparison of the two valve types. METHODS: All patients receiving either an Edwards Magna Ease valve or an Edwards INTUITY valve system due to aortic stenosis from May 2010 until July 2014 were included. Patients undergoing bypass surgery, an additional valve procedure, atrial ablation surgery or replacement of the ascending aorta were excluded. Preoperative characteristics, operative specifications, survival, valve-related adverse events and transvalvulvar gradients were compared. RESULTS: One hundred sixteen patients underwent rapid-deployment aortic valve replacement [mean age 75 years (SD: 8); 62% female] and 132 patients underwent conventional aortic valve replacement [70 years (SD: 9); 31% female; P < 0.001]. Conventional valve patients were taller and heavier. The mean EuroSCORE II was 3.1% (SD: 2.7) and 4.4% (SD: 6.0) for rapid-deployment and conventional valve patients, respectively (P = 0.085). The mean implanted valve size was higher in the conventional group [23.2 mm (SD: 2.0) vs 22.5 mm (SD: 2.2); P = 0.007], but postoperative transvalvular mean gradients were comparable [15 mmHg (SD: 6) vs 14 mmHg (SD: 5); P = 0.457]. A subgroup analysis of the most common valve sizes (21 and 23 mm; implanted in 63% of patients) revealed significantly reduced mean postoperative transvalvular gradients in the rapid-deployment group [14 mmHg (SD: 4) vs 16 mmHg (SD: 5); P = 0.025]. A significantly higher percentage received minimally invasive procedures in the rapid-deployment group (59 vs 39%; P < 0.001). The 1- and 3-year survival rate was 96 and 90% in the rapid-deployment group and 95 and 89% in the conventional group (P = 0.521), respectively. Valve-related pacemaker implantations were more common in the rapid-deployment group (9 vs 2%; P = 0.014) and postoperative stroke was more common in the conventional group (1.6 vs 0% per patient year; P = 0.044). CONCLUSIONS: We conclude that this rapid-deployment valve probably facilitates minimally invasive surgery. Furthermore, a subgroup analysis showed reduced transvalvular gradients in smaller valve sizes compared with the conventionally implanted valve of the same type. The favourable haemodynamic profile and the potentially different spectrum of valve-related adverse events should be addressed in further clinical trials.