Long-term mechanical circulatory support (LT-MCS) is an important treatment modality for patients with severe heart failure. Different devices are available, and many-sometimes contradictory-observations regarding patient selection, surgical techniques, perioperative management and follow-up have been published. With the growing expertise in this field, the European Association for Cardio-Thoracic Surgery (EACTS) recognized a need for a structured multidisciplinary consensus about the approach to patients with LT-MCS. However, the evidence published so far is insufficient to allow for generation of meaningful guidelines complying with EACTS requirements. Instead, the EACTS presents an expert opinion in the LT-MCS field. This expert opinion addresses patient evaluation and preoperative optimization as well as management of cardiac and non-cardiac comorbidities. Further, extensive operative implantation techniques are summarized and evaluated by leading experts, depending on both patient characteristics and device selection. The faculty recognized that postoperative management is multidisciplinary and includes aspects of intensive care unit stay, rehabilitation, ambulatory care, myocardial recovery and end-of-life care and mirrored this fact in this paper. Additionally, the opinions of experts on diagnosis and management of adverse events including bleeding, cerebrovascular accidents and device malfunction are presented. In this expert consensus, the evidence for the complete management from patient selection to end-of-life care is carefully reviewed with the aim of guiding clinicians in optimizing management of patients considered for or supported by an LT-MCS device.

• Keywords
• Expert consensus, Heart failure, Left ventricular assist devices, Mechanical circulatory support,
• MeSH
• Prosthesis Implantation instrumentation   methods   MeSH
• Cardiac Surgical Procedures instrumentation   methods   MeSH
• Humans MeSH
• Perioperative Care methods   MeSH
• Heart-Assist Devices * MeSH
• Postoperative Complications diagnosis   therapy   MeSH
• Heart Failure complications   diagnosis   surgery   MeSH
• Check Tag
• Humans MeSH
• Publication type
• Journal Article MeSH
• Consensus Development Conference MeSH

BACKGROUND: The novel HeartMate 3 (Abbott, Chicago, IL, USA) left ventricular assist device (LVAD) was worldwide first implanted by Prof. Schmitto and his team in 2014 at the Hannover Medical School, Germany and received CE Mark approval in October, 2015 following completion of a clinical trial. METHODS: Although HeartMate 3 implantation in the clinical trial was restricted to conventional sternotomy, the small size of the pump allows for less-invasive implantation, generally associated with less trauma and reduced perioperative complication rates. Herein we describe our first experiences with a less-invasive implantation of the HeartMate 3 using an upper hemi-sternotomy combined with anterior lateral thoracotomy approach. RESULTS: Results demonstrate the feasibility of this novel, less invasive technique for HeartMate 3 LVAD implantation with diminished surgical trauma, less postoperative bleeding, maintenance of the chest stability, reduced need of blood product transfusion and earlier recovery. CONCLUSIONS: The results of our study indicate that less-invasive implantation of the HeartMate 3 is technically feasible and offers several benefits for surgical outcome and may become the standard of care for LVAD implantation techniques.

• Keywords
• HeartMate 3, Less-invasive, implantation, left ventricular assist device (LVAD),
• Publication type
• Journal Article MeSH

BACKGROUND: The HeartMate 3 Left Ventricular Assist System (LVAS) (St. Jude Medical Inc., St Paul, MN) with full magnetic levitation allows for wide and consistent blood flow paths and an artificial pulse designed for enhanced hemocompatibility. The HeartMate 3 received market approval in the European Union in 2015 following completion of a multicenter study. After reaching the 6-month study endpoint, patients continue to be followed for 2 years with the 1-year results presented herein. METHODS: A prospective, non-randomized study included adults with advanced heart failure and ejection fraction (EF) ≤ 25%, cardiac index (CI) ≤ 2.2 L/min/m2 while not on inotropes, or inotrope dependent, or on optimal medical management for 45/60 days. RESULTS: Fifty patients-54% bridge to transplant (BTT) and 46% destination therapy (DT)-were enrolled and implanted with the HeartMate 3. At baseline, 92% of the patients were INTERMACS profiles 2-4, with cardiac index 1.8 + 0.5 L/min/m2 and 58% were supported with inotropes. At 1 year, 74% of the patients remain on support, 18% expired, 6% transplanted, and 2% explanted. The adverse events include 12% gastrointestinal bleeding, 16% driveline infections, 18% strokes, and 2% outflow graft thrombosis. There was no hemolysis, pump thrombosis or pump malfunction through 1 year. The six-minute walk test distance increased from a mean of 273 m to 371 m (P <0.0001). EQ-5D quality-of-life score increased from a mean of 52.7 to 70.8 (P = 0.0006). CONCLUSIONS: The 1-year HeartMate 3 LVAS results show survival and adverse-event profile are similar to other approved devices, with no pump thrombosis or pump failure. Patient's functional status and quality of life significantly improved over time. TRIAL REGISTRATION: Clinicaltrials.gov registration number: NCT02170363 . Registered June 19, 2014.

• Keywords
• Heart failure, HeartMate 3, LVAS, Magnetic levitation,
• MeSH
• Time Factors MeSH
• Equipment Design MeSH
• Hemodynamics physiology   MeSH
• Quality of Life MeSH
• Middle Aged MeSH
• Humans MeSH
• Magnets MeSH
• Follow-Up Studies MeSH
• Heart-Assist Devices * MeSH
• Prospective Studies MeSH
• Heart Failure physiopathology   therapy   MeSH
• Treatment Outcome MeSH
• Check Tag
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Clinical Trial MeSH