Updates of previous evaluations of individual medical procedures by the Austrian Institute for Health Technology Assessment

In July 2020, the Austrian Institute for Health Technology Assessment (AIHTA) published updated evaluations of medical procedures previously assessed. Technologies that were revised are Leadless pacemaker for right ventricle pacing and Extracorporeal cytokine hemadsorption therapy in patients with sepsis or SIRS.

The Austrian Ministry of Health receives every year proposals for reimbursement of new medical interventions. The research is conducted with the aim to evaluate the efficacy and safety of interventions, suggested being included in the MEL (individual medical services) catalog. Themes (interventions) were prioritized by the Ministry of Health and contracted to the AIHTA. The assessments are based on systematic reviews for each intervention and a summary of the scientific evidence according to the GRADE scheme.

First, the report “Leadless pacemaker for right ventricle pacing” is updated. In this report, the Micra™ Transcatheter Pacing System (TPS) from Medtronic was evaluated again. A systematic review was performed with a total of 16 new relevant documents (for 2. 976 people) on three ongoing prospective multicenter single-arm studies, one multicenter case-control study, and five other small single-center case series included. Evidence for efficacy assessment (compared to conventional pacemakers) was found as insufficient, but the Micra™ TPS showed certain advantages in terms of safety. Therefore, the inclusion of the technology in the catalog of benefits is recommended with restrictions only to well-defined patient groups after careful risk assessment und under extensive documentation.

“Extracorporeal cytokine hemadsorption therapy in patients with sepsis or SIRS” report has also been updated. The systematic literature review was performed with five randomized controlled trials (RCT) investigated the preventive use of the technology in patients undergoing cardiac surgery, and two RCT investigated the therapeutic use of the technology in patients with sepsis or septic shock. Based on the selected essential endpoints, none of the included studies could prove that extracorporeal cytokine adsorption therapy in combination with the standard care compared to the sole standard care is more effective and at least equally safe in the two indications. Given the lack of evidence available, the re-evaluation is recommended in 2022 if larger randomized controlled trials will be published.

See all decision support documents in German and/or English here.

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