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                                  Current & archive

                                  Adobestock-1990837361

                                  Transcatheter aortic valve implantation (TAVI) in patients at intermediate surgical risk

                                  Transcatheter aortic valve implantation (TAVI, also called percutaneous aortic valve replacement) is the insertion of a bioprosthesis into the aortic valve using a catheter. Since the introduction of TAVI in 2007 for patients at high surgical risk, TAVI is being used more and more frequently. The EUnetHTA report with a German summary analyzes the results from 2 RCTs on patients with moderate operative risk.

                                  Publication: LBI-HTA Projektbericht No.115: https://eprints.aihta.at/1188/

                                  Contact: Claudia Wild

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                                  Wearable cardioverter-defibrillator (WCD) therapy in primary and secondary prevention of sudden cardiac arrest in patients at risk. Updtae 2018

                                  Sudden cardiac arrest (SCA) is the most common cause of death in patients with coronary artery disease. In Europe, there are about 350 000 out of hospital SCAs per year. Mostly, ventricular tachycardia and ventricular fibrillation are the underlying aetiology of SCA. The wearable cardioverter defibrillator (WCD) – a novel defibrillation therapy – claims to prevent sudden cardiac deaths that may result from SCA. To date, it is unclear whether the plausible and promising theoretical benefits can be translated into clinically relevant benefits.

                                  Therefore, the project at hand aimed at synthesising the current available evidence regarding the use of the WCD: A systematic review regarding the effectiveness and safety of the WCD was hereby performed.
                                  In total, 11 studies were identified: 1 RCT was eligible for the evidence synthesis of the effectiveness of the WCD and further 10 observational studies were additionally included for the evaluation of safety of the device. The scientific evidence from 1 RCT indicates the WCD in combination with guideline-directed medical therapy (GDMT) is not proven to be more effective than GDMT alone based on the endpoint arrhythmic mortality. The studies included in the evaluation of safety of the device suggest that the WCD could be a relatively safe device.

                                  To date, the comparative effectiveness of the WCD could not be established – it is unclear if and especially for whom the plausible theoretical advantages of using the WCD can be translated into clinically relevant benefits. Further research is needed in this context.

                                  Publication: Decision Support Document No. 103/Update 2018: https://eprints.aihta.at/1186

                                  Contact: Gregor Götz

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                                  2137

                                  Horizon Scanning in Oncology - Reports

                                  We are pleased to introduce our two new HSO reports.

                                  DSD HSO No. 85
                                  Ibrutinib (Imbruvica®) in combination with rituximab for the treatment of Waldenström’s macroglobulinemia

                                  DSD HSO No. 84
                                  Enzalutamide (Xtandi®) in patients with nonmetastatic, castration-resistant prostate cancer (CRPC)

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                                  Fotolia-43623827-s1

                                  Drug reimbursement in the inpatient sector in Austria: Approaches for a transparent and evidence-based process taking into account international experience

                                  On the one hand, reimbursement decisions on medicines in Austria are divided into outpatient and inpatient sector, on the other hand, decisions are made regionally in the inpatient sector (on a federal state level). Both can result in an unequal availability in particular of high-priced drugs. In favour of equal access to medical services, often there are deliberative decision-making processes that seek to make public (health policy) decisions fairly, transparently, and evidence-based. The present HTA report provides a basis for discussion of an Austria-wide standardised and transparent reimbursement process for high-priced hospital drugs taking into account deliberative processes.

                                  Publication: LBI-HTA Projektbericht No. 109: https://eprints.aihta.at/1183/

                                  Contact: Sarah Wolf, Claudia Wild

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                                  Fotolia-82419510-m1

                                  Inhalation sedation with laughing gas (N2O) in dentistry – organisational and professional aspects and a systematic review of efficacy and safety

                                  In the care of patients with fears of dental treatment, inhalation sedation with nitrous oxide (N2O) in the context of anxiety and behavioural management in dentistry is of central importance. The administration of inhalation sedation with N2O in dentistry serves the minimal or conscious sedation of the patient. Against this background, the report focuses on organizational and professional aspects as well as the systematic analysis of the efficacy and safety of inhalation sedation with N2O.

                                  Publication: LBI-HTA Project report No. 105: https://eprints.aihta.at/1182/

                                  Contact: Katharina Rosian

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                                  Prevalence of mental disorders and uptake of mental health services in Tyrol: An analysis of epidemiological literature and administrative data from the Tyrolean health insurance

                                  A recently started 4-year research project aims at improving the situation of children who have mentally ill parents in Tyrol. Different approaches can be followed for early identifying and supporting these children. One is to get into contact with the children via the parents in the adult mental health care settings. To explore this strategy further, we analysed the prevalence of mental disorders and the use of mental health benefits that are provided within the health care sector in Tyrol. Our data sources were published literature and administrative data from the Tyrolean health insurance.

                                  Publication: LBI-HTA Project report No. 113b: https://eprints.aihta.at/1181/

                                  Contact: Ingrid Zechmeister-Koss

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                                  Village-logo-fin1

                                  Supporting children who have parents with mental disorders in Tyrol: A mapping of existing Tyrolean support and societal structures

                                  A recently started 4-year research project aims at improving the situation of children who have mentally ill parents in Tyrol. For developing practice approaches to better identify and support these children and their parents, we need an in-depth understanding of the regional Tyrolean characteristics in terms of existing support structures and the societal context they are embedded in. The report gives an overview on the socio-economic and demographic context in Tyrol and describes available in-kind and cash-benefits that may play a role in improving identifying and supporting the children and their families.

                                  Publication: LBI-HTA Project report No. 103a: https://eprints.aihta.at/1180/

                                  Contact: Ingrid Zechmeister-Koss

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                                  PET/PET-CT Evidence for need based planning in Germany and Austria

                                  Hardly any other medical technology has been evaluated as often in the western countries as positron emission tomography (PET/PET-CT): this is an expression of uncertainty about the value of PET diagnostics in the care of patients. The present HTA report updates the evidence on oncological indications and adds neurological indications and inflammatory diseases to the LBI-HTA report from 2015. The report was conducted in cooperation between the TU Berlin and the LBI-HTA to provide an updated decision support for evidence-based PET/PET-CT planning in Germany and Austria.

                                  Publication: LBI-HTA Project report No. 77/ Update: https://eprints.aihta.at/1178/

                                  Contact: Claudia Wild & Nicole Grössmann

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                                  Fotolia-2013188-s1

                                  External stimulation of the trigeminal nerve for the prevention and acute treatment of episodic and chronic migraine

                                  External trigeminal nerve stimulation (e-TNS) device produced by the manufacturer Cefaly is the intervention at stake. The mechanism of action is that e-TNS produces a micro-pulse on the upper branch of the trigeminal nerve (suborbital nerve) through an adhesive electrode that is placed on the forehead. The aim of the project is to perform a synthesis of evidence on the basis of a systematic literature search regarding effectiveness and safety of the e-TNS for the prevention and treatment of episodic and chronic migraine.

                                  Publication: Decision Support Document No. 114: https://eprints.aihta.at/1177/

                                  Contact: Michal Stanak

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                                  2136

                                  Horizon Scanning in Oncology - Reports

                                  We are pleased to introduce our two new HSO reports.

                                  DSD HSO No. 83
                                  Pembrolizumab (Keytruda®) in combination with chemotherapy for the treatment of metastatic non-small-cell lung cancer (NSCLC)

                                  DSD HSO No. 82
                                  Nivolumab (Opdivo®) in combination with ipilimumab (Yervoy®) for the first-line treatment of patients with advanced RCC

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