Aims: To investigate the efficacy and safety of early transition from hospital to ambulatory treatment in low-risk acute PE, using the oral factor Xa inhibitor rivaroxaban. Methods and results: We conducted a prospective multicentre single-arm investigator initiated and academically sponsored management trial in patients with acute low-risk PE (EudraCT Identifier 2013-001657-28). Eligibility criteria included absence of (i) haemodynamic instability, (ii) right ventricular dysfunction or intracardiac thrombi, and (iii) serious comorbidities. Up to two nights of hospital stay were permitted. Rivaroxaban was given at the approved dose for PE for ≥3 months. The primary outcome was symptomatic recurrent venous thromboembolism (VTE) or PE-related death within 3 months of enrolment. An interim analysis was planned after the first 525 patients, with prespecified early termination of the study if the null hypothesis could be rejected at the level of α = 0.004 (<6 primary outcome events). From May 2014 through June 2018, consecutive patients were enrolled in seven countries. Of the 525 patients included in the interim analysis, three (0.6%; one-sided upper 99.6% confidence interval 2.1%) suffered symptomatic non-fatal VTE recurrence, a number sufficiently low to fulfil the condition for early termination of the trial. Major bleeding occurred in 6 (1.2%) of the 519 patients comprising the safety population. There were two cancer-related deaths (0.4%). Conclusion: Early discharge and home treatment with rivaroxaban is effective and safe in carefully selected patients with acute low-risk PE. The results of the present trial support the selection of appropriate patients for ambulatory treatment of PE.
15 January 2011 in Graefe's Archive for Clinical and Experimental Ophthalmology
Summary: Unanticipated difficulties during tracheal intubation and failure to intubate are among the leading causes of anaesthesia‐related morbidity and mortality. Using the technique of video laryngoscopy, the alignment of the oral and pharyngeal axes to facilitate tracheal intubation is unnecessary. In this study we evaluated the McGrath ® Series 5 videolaryngoscope for tracheal intubation in 61 patients who exhibited Cormack and Lehane grade 3 or 4 laryngoscopies with a Macintosh laryngoscope. Using the McGrath resulted in an improved glottic view, compared to Macintosh laryngoscope. Laryngoscopy was improved by one grade in 10%, by two grades in 80% and by three grades in 10% of cases (p < 0.0001). The success rate for intubation was 95% with the McGrath. These results suggest that the McGrath videolaryngoscope can be used with a high success rate to facilitate tracheal intubation in difficult intubation situations.
Tinnitus is a common symptom reported in otolaryngologic practice. Although the pathophysiology of tinnitus has not been fully understood, clinical studies suggest that psychological symptoms of depression, anxiety, and somatization are increased in tinnitus patients. However, patients seeking medical treatment for tinnitus may be especially vulnerable. Population-based studies reporting on the association between tinnitus and psychological distress are still lacking. The aim of this study was to investigate the correlation of tinnitus with depression, anxiety, or somatization in a large population-based cohort. The Gutenberg Health Study is a population-based cohort study. Participants were asked about the occurrence of tinnitus (yes/no) and how much they were bothered by it. In addition, they completed the PHQ-9, GAD-7, and SSS-8 questionnaires to assess depressive symptoms, anxiety, and somatic symptom disorders. A total of 8539 participants were included in the study cohort. Tinnitus prevalence was 28.0% (2387). The prevalence of depression/anxiety/somatic symptom disorders was significantly higher among participants with tinnitus than among participants without tinnitus (7.9%/5.4%/40.4% participants with tinnitus vs. 4.6%/3.3%/26.9% participants without tinnitus, p-value < 0.0001). Logistic regression results showed that participants with tinnitus were more likely to suffer from depression (OR = 2.033, 95% CI [1.584; 2.601], p-value < 0.0001), anxiety (OR = 1.841, 95% CI [1.228; 2.728], p-value = 0.0027), or somatic symptom disorders (OR = 2.057, 95% CI [1.799; 2.352], p-value < 0.0001). Symptoms of depression, anxiety, and somatic symptom disorders were increased in participants with tinnitus. This must be taken into account when treating these patients.