Swedish Evaluation of Left Ventricular Assist Device
The study is a prospective, randomized, non-blinded, national, multi-center study. The study will consist of the assignment of eligible patients to treatment with either a HeartMate III (HM III) left ventricular assist device system or to pharmacological treatment (optimal medical management, OMM) according to current guidelines. Eighty (80) patients will be enrolled in this study and randomized in a 1:1 fashion between the HM III and OMM, based on a modified power calculation.
• Signed informed consent
• Adult (≥ 18 years)
• Chronic heart failure ≥ 45 days or stable not supported by mechanical circulatory support since \>7days on single inotrope.
• Left ventricular ejection fraction ≤ 30%.
• NYHA IIIB-IV, INTERMACS profile 2-6
• At least 2 of 4 adverse prognostic criteria:
‣ SHFM estimated 1-year survival ≤75%
⁃ NTproBNP ≥ 2000 ng/l
⁃ VO2 max \< 14 ml/kg/min or \<50% of predicted VO2max with attainment of anaerobic threshold (AT), or unable to perform.
⁃ Need for continuous or intermittent inotropic support or \>2 hospitalizations during last 6 months.
• Receiving medical management with optimal doses of betablockers, ACE-inhibitors or ARBs, and MRAs for at least 30 days if tolerated.
• Receiving CRT if indicated for at least 45 days.
• Receiving ICD if indicated and appropriate.
⁃ Ineligible for cardiac transplantation (e.g. high age and/or co-morbidities)
⁃ Considered suitable for the study by a multidisciplinary board