First Long-Term 5-years Experience with the HeartMate 3 LVAS in Multicentric Clinical Trial.

The HeartMate 3 (HM3) Long Term Follow Up Study (NCT03022461) is an extension of the original HM3 CE mark study where patients ongoing at 2-year follow-up were reconsented and followed up to 5 years with the aim to evaluate the long-term performance in the patients who continue to be implanted with the HM3 LVAS. Of the 50 patients enrolled in the HM3 CE Mark Study, 5 (10%) patients were transplanted, 1 (2%) was explanted, 12 (24%) expired prior to 24 months, 4 (8%) expired after 24 months but prior to reconsent for the additional follow-ups, 3 (6%) denied their participation to the study extension while 25 (50%) consented for the extended follow-up. To date, of the 25 reconsented patients, 2 patients expired (8%) whereas 23 patients (92%) are still ongoing on support. Additional adverse events collected beyond 2 years included: major bleeding (3 events in 2 patients, 8%) of which 1 (4%) required surgery; major infection (16 events in 8 patients, 32%) of which 8 were driveline infection in 6 pts (32%) and 6 sepsis in 2 patients (8%); ischemic stroke (2 events in 2 pts, 8%), haemorrhagic stroke (1 event in 1 patient, 4%) and right heart failure in 1 patient (4%) which was resolved pharmacologically. No pump thrombosis, hemolysis or gastrointestinal bleeding were reported during the extended follow-up period. At the time of data cut-off, 4 patients (16%) were in NYHA Class I and 6 (24%) in NYHA Class II. Preliminary five years results of the first clinical experience with HM3 LVAS implantation corroborate expected and well acceptable survival and support outstanding hemocompatibility of the device represented by complete absence of pump thrombosis, hemolysis or gastrointestinal bleeding. To the date, 5 years follow-up visits were completed in 10 patients and full longitudinal follow-up will be accomplished by January 2020. [ABSTRACT FROM AUTHOR]