Official title: MIRAMACS, Multicenter Italian Study on RAdial Mechanically Assisted Circulatory Support Summary: The Multicenter Italian Study on Radial Mechanically Assisted Circulatory Support (MIRAMACS) is an independent, non-sponsored, nationwide observational study designed to evaluate the clinical outcomes and device performance of continuous-flow ventricular assist devices (VAD), including both second and third-generation axial and centrifugal pumps, in the adult population. Coordinated by the Cardiac Surgery Department at the IRCCS Sant'Orsola Polyclinic in Bologna, the study aims to establish a comprehensive multicenter collaboration involving the majority of Italian reference centers for advanced heart failure.
The primary objective is to assess patient survival at multiple time points, specifically focusing on in-hospital mortality and survival rates at one and five years post-implantation. Secondary objectives encompass a wide range of clinical and surgical metrics, including the duration of hospitalization, intensive care unit stay, and mechanical ventilation.
The study will also rigorously monitor the incidence of adverse events such as right ventricular failure (with or without the need for temporary mechanical support), bleeding, thromboembolic episodes, systemic organ dysfunction, and the requirement for renal replacement therapy.
MIRAMACS: Scope, Design, and Practical Focus for Radial Mechanical Support Devices:
Its aim is to evaluate clinical outcomes and device performance of continuous-flow ventricular assist devices (VADs), encompassing both second- and third-generation axial and centrifugal pumps, in adults.
The project seeks broad participation from most Italian reference centers dedicated to advanced heart failure, representing a nationwide collaboration.
The anticipated cohort exceeds 400 cases.
The captured domains include pre-operative diagnostics, operative details, post-operative course, and long-term follow-up.