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Int J Artif Organs ; 45(7): 615-622, 2022 Jul.
Article in English | MEDLINE | ID: covidwho-1886858

ABSTRACT

OBJECTIVE: Patients with severe manifestations of COVID-19 might exhibit characteristics of a sepsis-like syndrome that can progress to multiple organ failure and ultimately death. Underlying mechanism have been explored and suggest a profound dysregulation of the immune system associated with hyperinflammation, hemodynamic instability and respiratory failure. Besides standard intensive care treatment, approaches modulating the dysregulated immune response, such as CytoSorb hemoadsorption, have been used. However, data of ECMO-dependent patients in comparison to a control cohort remain scarce. METHODS: Included were 26 critically ill COVID-19 patients requiring high-flow veno-venous extracorporeal membrane oxygenation (high-flow VV ECMO) therapy due to severe acute respiratory distress syndrome (ARDS), of whom 16 were additionally treated with an extracorporeal hemoadsorption device, and compared to a control group of 10 patients. Assessed were levels of inflammatory markers, vasopressor requirements, oxygenation parameters, as well as clinically relevant outcome variables. Data were prospectively recorded and retrospectively analyzed. RESULTS: Treatment with the applied multimodal therapy approach resulted in a stabilization in hemodynamics, a control of the hyperinflammatory response as evidenced by a significant reduction in inflammatory mediators, as well as a marked improvement in lung function. No device related adverse events were observed while treatment appeared safe and feasible. CONCLUSION: Treatment of a critically ill COVID-19 ARDS patients with combined VV ECMO support and hemoadsorption therapy led to a rapid and sustained hemodynamic stabilization, a control of the uncontrolled inflammatory response and an improvement in oxygenation. Given these signals pointing toward a patient-oriented benefit of extracorporeal hemoadsorption therapy in those patients, future controlled, randomized studies should focus on the investigation of the appropriate timing and dosing of this promising treatment modality.


Subject(s)
COVID-19 , Extracorporeal Membrane Oxygenation , Respiratory Distress Syndrome , COVID-19/complications , COVID-19/therapy , Critical Illness , Extracorporeal Membrane Oxygenation/methods , Humans , Respiratory Distress Syndrome/etiology , Respiratory Distress Syndrome/therapy , Retrospective Studies
2.
Health Policy ; 124(12): 1287-1296, 2020 12.
Article in English | MEDLINE | ID: covidwho-778872

ABSTRACT

Shortages of medicines have become a major public health challenge. The aim of this study was to survey national measures to manage and combat these shortages. A questionnaire survey was conducted with public authorities involved in the Pharmaceutical Pricing and Reimbursement Information (PPRI) network. Reponses relating to measures as of March / April 2020 were received from 24 countries (22 European countries, Canada and Israel). In 20 countries, manufacturers are requested to notify - usually on an obligatory basis - upcoming and existing shortages, which are recorded in a register. Further measures include a regular dialogue with relevant stakeholders (18 countries), financial sanctions for manufacturers in cases of non-supply and/or non-compliance with reporting or stocking requirements (15 countries) and simplified regulatory procedures (20 countries). For defined medicines, supply reserves have been established (14 countries), and legal provisions allow the issuing of export bans (10 countries). Some measures have been introduced since the end of 2019 and countries are planning and discussing further action. While governments reacted by taking national measures, the COVID-19 crisis might serve as an opportunity to join forces in cross-country collaboration and develop joint (e.g. European) solutions to address the shortage issue in a sustainable manner. A practical first step could be to work on a harmonisation of the national registers.


Subject(s)
Drug Industry/legislation & jurisprudence , Legislation, Drug , Pharmaceutical Preparations/supply & distribution , COVID-19 , Canada , Cross-Sectional Studies , Europe , Humans , Israel , Surveys and Questionnaires
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