ELICITATION WITHIN EHTA: POTENTIAL EFFICACY OF MELATONIN MEDICATION FOR STEMI PATIENTS WITH DETECTED HIGH RISK OF REPERFUSION VENTRICULAR FIBRILLATION DURING PCI

Patients with acute ST-segment elevation myocardial infarction (STEMI) have a high risk of ventricular fibrillation. The aim of the study is to determine an unknown parameter of the new diagnostic cardiology technology model created within eHTA, effectiveness of intravenous administration of high doses of melatonin (4mg/kg) before/during PCI as protective medication in STEMI patients with a diagnosed by new technology high risk of ventricular fibrillation at reperfusion using expert elicitation. Ten experts took part in the elicitation and filled out prepared questionnaire, which included experimental evidence for antiarrhythmic action of melatonin, including cellular mechanisms. They expressed their opinions on the potential effectiveness of medication using numerical method and also answered questions about the suitability of the dosage, adverse effects and the risk-benefit ratio. Experts' answers to the main research question were weighted based on their experience. Elicitation revealed the effectiveness value of 71.82% for the tested medication. Eighty percent of experts agreed that the dose is adequate, that side effects will be minimal, and that the benefits of such therapy outweigh possible risks. Results of this study will be applied for eHTA of novel diagnostic technology in cardiology and will help its manufacturer to evaluate the clinical effectiveness of the technology, find the right direction to complete the design and development of medical device, achieve optimal efficiency, present the concept and find investors, prepare for clinical evaluation, CE certification and inclusion to reimbursement system.