AIMS: Over decades, left ventricular assist device (LVAD) technology has transitioned from less durable bulky pumps to smaller continuous-flow pumps which have substantially improved long-term outcomes and quality of life. Contemporary LVAD therapy is beleaguered by haemocompatibility-related adverse events including thrombosis, stroke and bleeding. A fully magnetically levitated pump, the HeartMate 3 (HM3, Abbott, USA) LVAD, has been shown to be superior to the older HeartMate II (HMII, Abbott, USA) pump by improving haemocompatibility. Experience with the HM3 LVAD suggests near elimination of de-novo pump thrombosis, a marked reduction in stroke rates, and only a modest decrease in bleeding complications. Since the advent of continuous-flow LVAD therapy, patients have been prescribed a combination of aspirin and anticoagulation therapy on the presumption that platelet activation and perturbations to the haemostatic axis determine their necessity. Observational studies in patients implanted with the HM3 LVAD who suffer bleeding have suggested a signal of reduced subsequent bleeding events with withdrawal of aspirin. The notion of whether antiplatelet therapy can be avoided in an effort to reduce bleeding complications has now been advanced. METHODS: To evaluate this hypothesis and its clinical benefits, the Antiplatelet Removal and Hemocompatibility Events with the HeartMate 3 Pump (ARIES HM3) has been introduced as the first-ever international prospective, randomized, double-blind and placebo-controlled, non-inferiority trial in a patient population implanted with a LVAD. CONCLUSION: This paper reviews the biological and clinical role of aspirin (100 mg) with LVADs and discusses the rationale and design of the ARIES HM3 trial.

• Klíčová slova
• Advanced heart failure, Aspirin, Assist devices, Bleeding, Hemocompatibility, LVAD, Mechanical Circulatory Support, Outcomes,
• MeSH
• Aspirin MeSH
• kvalita života MeSH
• lidé MeSH
• podpůrné srdeční systémy * MeSH
• prospektivní studie MeSH
• randomizované kontrolované studie jako téma MeSH
• srdeční selhání * terapie   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• přehledy MeSH
• Názvy látek
• Aspirin MeSH

INTRODUCTION: Changes in circulating CD34+CD45low stem cells (SC) and CD34+CD45low+KDR+ endothelial progenitor cells (EPC) may reflect pathological endothelial activation. Non-pulsatile/continuous-flow left ventricular assist devices (CF-LVAD) can enhance this process. The aim of this study was to analyse the impact of 12-month CF-LVAD treatment on SC and EPC. METHODS: We analysed changes in SC and EPC from the pre-implantation period up until 12 months after implantation over 3-month intervals in 14 patients. Data from 12 patients with heart failure (HF) and from 13 healthy volunteers were used as controls. RESULTS: Baseline EPC were significantly higher in CF-LVAD and HF patients than in healthy controls, substantially decreasing 3 months after CF-LVAD implantation and then returning to high baseline values at 12 months. CONCLUSIONS: Changes in circulating SC and EPC may reflect pathological endothelial activation after CF-LVAD implantation.

• Klíčová slova
• continuous flow, endothelial damage, endothelial progenitor cells, mechanical circulatory support, stem cells,
• Publikační typ
• časopisecké články 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.

• Klíčová slova
• Heart failure, HeartMate 3, LVAS, Magnetic levitation,
• MeSH
• časové faktory MeSH
• design vybavení MeSH
• hemodynamika fyziologie   MeSH
• kvalita života MeSH
• lidé středního věku MeSH
• lidé MeSH
• magnety MeSH
• následné studie MeSH
• podpůrné srdeční systémy * MeSH
• prospektivní studie MeSH
• srdeční selhání patofyziologie   terapie   MeSH
• výsledek terapie MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky MeSH