Multicenter Italian Study on Radial Mechanically Assisted Circulatory Support (MIRAMACS): Preliminary Results

Abstract

Purpose The Multicenter Italian study on RAdial Mechanically Assisted Circulatory Support (MIRAMACS) represent the first national observational registry, gathering continuous-flow (CF) left ventricular (LVAD) and biventricular assist device (BiVAD) implantation performed in adult patients by high-volume, mechanical circulatory support (MCS) dedicated, Italian centres. Methods Seven participating hospitals contributed pre-, peri- and long-term postoperative data on LVAD implants to the registry. Data for all implants in adult patients (>18 years of age) performed between January 2000 to September 2020 were analysed. BiVADs were excluded in this preliminary analysis. This initial report focuses on patient demographics, survival, device types, adverse events and competing outcomes. Results A total of 515 patients received a CF LVAD. The mean age of LVAD recipients was 60±10 years. The majority of patients were male (89.3%). The adopted systems were: HeartWare HVAD (n=213), HeartMate III (n=140), HeartMate II (n=89), Jarvik 2000 (n=50), Berlin Heart Incor (n=19) and other brands (n=4). In 6.6% of patients the LVAD implantation was performed by usage of less invasive surgical approaches. Mortality at 30- and 90-days was 6.1% and 11.1%, respectively. A temporary right ventricular assist device (RVAD) support was necessary in 3.1% of patients. Mean follow-up time was 57±15 months. Heart transplantation was performed in 99 patients (19.2%). Survival at 1-year, 3-years, and 5-years of BTT cohort was 82.1%, 60.4% and 41.8%, respectively. Survival at 1-year, 3-years, and 5-years of DT cohort was 69.8%, 45.6% and 30.1%, respectively. Major bleeding, major infection, neurological events and device malfunction were reported in 40 (7.7%), 143 (27.7%), 97 (18.8%) and 36 (6.9%) patients, respectively. Conclusion This first MIRAMACS report reveals frequencies and results comparable with other registries. Overall success rate of CF LVAD patients seems to be satisfactory. Detailed prospective data collection, additional participating centres and further analyses may provide additional robust scientific contributions.