Evaluation of low-intensity anti-coagulation with a fully magnetically levitated centrifugal-flow circulatory pump-the MAGENTUM 1 study
Jazyk angličtina Země Spojené státy americké Médium print-electronic
Typ dokumentu časopisecké články, práce podpořená grantem
PubMed
29655662
DOI
10.1016/j.healun.2018.03.002
PII: S1053-2498(18)31383-4
Knihovny.cz E-zdroje
- Klíčová slova
- HeartMate 3, INR management, LVAD, Rosendaal method, TTR, left ventricular assist device, reduced intensity anti-coagulation, time in therapeutic range,
- MeSH
- antikoagulancia aplikace a dávkování škodlivé účinky MeSH
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- pilotní projekty MeSH
- podpůrné srdeční systémy * MeSH
- prospektivní studie MeSH
- protézy - design MeSH
- senioři MeSH
- srdeční selhání chirurgie MeSH
- warfarin aplikace a dávkování škodlivé účinky MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- Názvy látek
- antikoagulancia MeSH
- warfarin MeSH
BACKGROUND: The HeartMate 3 left ventricular assist system is engineered to avoid pump thrombosis, yet bleeding complications persist. We investigated the safety of low-intensity anti-coagulation in patients with the HeartMate 3. METHODS: The Minimal AnticoaGulation EvaluatioNTo aUgment heMocompatibility (MAGENTUM 1) pilot study is a prospective, single-arm study of low-intensity warfarin anti-coagulation in patients implanted with the HeartMate 3 pump. After standard warfarin anti-coagulation (international normalized ratio [INR] 2.0 to 3.0) and aspirin for 6 weeks post-implant, patients were transitioned to a lower INR target range of 1.5 to 1.9. The primary end-point was a composite of survival free of pump thrombosis, disabling stroke (modified Rankin score [MRS] >3), or major bleeding (excluding peri-operative bleeding) with at least 6-month post-implant follow-up. Time in therapeutic range (TTR) was measured to assess anti-coagulation target efficacy using the Rosendaal method. A safety algorithm to monitor for signs of pump thrombosis was developed and implemented. RESULTS: We enrolled 15 patients (mean age 57.3 ± 13.3 years), 13 men with advanced heart failure (67% with INTERMACS Profiles 2 or 3), irrespective of therapeutic goal of bridge-to-transplant or destination therapy. The primary end-point was met in 14 of 15 (93 ± 6%) patients; 1 patient developed recurrent gastrointestinal bleeding. The TTR during the reduced anti-coagulation phase (6 weeks to 6 months) was 75.3 ± 8.6%. No thrombotic events occurred. CONCLUSIONS: This pilot study suggests low-intensity anti-coagulation targeting an INR between 1.5 and 1.9 is achievable and safe with the HeartMate 3 cardiac pump in the short-term phase, 6-months post-implant. A large-scale trial is now warranted.
Department of Pharmacy Brigham and Women's Hospital Harvard Medical School Boston Massachusetts USA
Department of Pharmacy Institute for Clinical and Experimental Medicine Prague Czech Republic
Division of Hematology Brigham and Women's Hospital Harvard Medical School Boston Massachusetts USA
Global Clinical Heart Failure Abbott Burlington Massachusetts USA
Citace poskytuje Crossref.org
ClinicalTrials.gov
NCT03078374
