BACKGROUND:Whether anticoagulation alone is an adequate treatment for acute, intermediate-risk pulmonary embolism is uncertain. METHODS:We conducted a multinational, adaptive-design trial with blinded outcome adjudication. Patients with intermediate-risk pulmonary embolism (with a ratio of right ventricular end-diastolic diameter to left ventricular end-diastolic diameter of ≥1.0 and an elevated troponin level) were eligible if they had at least two indicators of cardiorespiratory distress (systolic blood pressure of ≤110 mm Hg, a heart rate of ≥100 beats per minute, or a respiratory rate of >20 breaths per minute). Patients were randomly assigned to undergo ultrasound-facilitated, catheter-directed fibrinolysis with alteplase plus anticoagulation (the intervention group) or anticoagulation alone (the control group) according to prespecified treatment protocols. The primary outcome was a composite of pulmonary embolism-related death, cardiorespiratory decompensation or collapse, or symptomatic recurrence of pulmonary embolism within 7 days. RESULTS:The intention-to-treat population comprised 544 patients: 273 in the intervention group and 271 in the control group. The mean (±SD) age was 58.2±13.5 years, and 42.6% of the patients were women. A primary-outcome event occurred in 11 patients (4.0%; 95% confidence interval [CI], 2.3 to 7.1) in the intervention group and 28 (10.3%; 95% CI, 7.2 to 14.5) in the control group (relative risk, 0.39; 95% CI, 0.20 to 0.77; P = 0.005). The effect was driven primarily by a lower risk of cardiorespiratory decompensation or collapse in the intervention group. Major bleeding occurred within 7 days after randomization in 11 patients (4.1%) in the intervention group and 6 (2.2%) in the control group (P = 0.32); major bleeding occurred within 30 days in 11 patients (4.1%) and 8 patients (3.0%), respectively (P = 0.64). No substantial between-group differences in the incidence of other serious adverse events were observed up to 30 days after randomization; no intracranial hemorrhage occurred. CONCLUSIONS:In patients with acute, intermediate-risk pulmonary embolism, ultrasound-facilitated, catheter-directed fibrinolysis plus anticoagulation led to a lower risk of the composite of pulmonary embolism-related death, cardiopulmonary decompensation or collapse, or symptomatic recurrence of pulmonary embolism within 7 days than anticoagulation alone. (Funded by Boston Scientific; HI-PEITHO ClinicalTrials.gov number, NCT04790370.).
This study investigates the relationship between hearing loss and cognitive decline in elderly people living in care facilities in the greater Hanover area. Hearing loss was assessed using pure-tone and speech audiograms, while cognitive decline was assessed using the mini-mental status test (MMST) and the clock-drawing test. A follow-up examination was carried out on 38 participants after 1 year. The data suggest a tendency toward residents with poorer hearing exhibiting a faster rate of cognitive decline. These results emphasize the importance of treating hearing impairment in elderly care to mitigate cognitive decline and the progression of possible dementia.
Zusammenfassung Die Cochlea-Implantat (CI)-Versorgung ist in Deutschland durch die AWMF-Leitlinie „Cochlea-Implantat-Versorgung“, das CI-Weißbuch der Deutschen Gesellschaft für Hals-Nasen-Ohren-Heilkunde, Kopf- und Hals-Chirurgie e.V. (DGHNO-KHC) sowie etablierte Zertifizierungsstrukturen standardisiert. Ziel dieses im Auftrag des Präsidiums der DGHNO-KHC erstellten Dokuments ist die fachliche, organisatorische und vergütungsbezogene Einordnung der Delegation technischer Nachsorgeleistungen auf Grundlage der CI-Leitlinie, des CI-Weißbuchs sowie praktischer Erfahrungen aus leitlinienbasierten Kooperationen. Die Analyse zeigt, dass technische Nachsorgeleistungen leitliniengerecht delegiert werden können, sofern sie durch die verantwortliche CIVE im Rahmen einer Kooperationsvereinbarung veranlasst werden, das Einverständnis des Patienten vorliegt und die Gesamtverantwortung für den Versorgungsprozess bei der CIVE verbleibt. Die Delegation kann sich auf einzelne oder sämtliche Anteile der technischen Nachsorge erstrecken; ein „Alles-oder-Nichts-Prinzip“ besteht nicht. Nicht delegierbar bleiben insbesondere medizinische und komplexe audiologische Nachsorgeleistungen sowie sämtliche audiologischen und technischen Leistungen der Basis- und Folgetherapie. Ein eigenständiger Anspruch externer Leistungserbringer auf Durchführung technischer Nachsorge besteht nicht. Die Zustimmung zur Delegation kann von der CIVE oder dem Patienten jederzeit widerrufen werden. Die Vergütung technischer Nachsorgeleistungen ist bislang bundesweit nicht einheitlich geregelt, insbesondere aufgrund fehlender Vertragsstrukturen.
Familial occurrence of gliomas has been reported in around 5% of patients. Studies on the genetic landscape of glioma predisposition are scarce. Here, leukocyte DNA of 213 adult glioma patients with a familial and/or personal tumor history from 206 families was subjected to whole-exome sequencing. Germline variants (GVs) were analyzed using two approaches: (1) GVs in 164 established cancer predisposition genes (CPGs) or suspected glioma risk genes were extracted and classified; (2) the enrichment of genes with loss-of-function or deleterious missense GVs that were ultrarare or ClinVar likely pathogenic/pathogenic in the glioma versus a control cohort (n = 391) was determined. In 23% (48/213) of glioma patients with a familial/personal tumor history, GVs predicted to be deleterious in CPGs were detected. Of the mutated CPGs, 37% were involved in DNA damage response, including ATM, BRCA2, PMS2, POLE. ATM GVs (n = 6) preferentially predisposed to IDH-mutant astrocytoma (P = 0.007) in patients that were significantly younger at diagnosis than patients without GVs (P = 0.022). BRCA2 GVs (n = 5) were also significantly enriched in glioma patients in approach 2 (P = 0.005). The other mutated CPGs, glioma risk or enriched novel genes play roles in diverse processes, including metabolism and signal transduction. Syn-/metachronous non-brain tumors were diagnosed in 29% of glioma patients with GVs. In 11% of patients, the identified CPG GVs potentially sensitized to targeted therapies, such as PARP, immune checkpoint, or EGFR inhibitors. In conclusion, our study identifies CPGs and novel genes relevant in germline testing of glioma patients with a familial/personal tumor history, possibly resulting in targeted treatment options.
