Evaluation of low-intensity anti-coagulation with a fully magnetically levitated centrifugal-flow circulatory pump-the MAGENTUM 1 study
Language English Country United States Media print-electronic
Document type Journal Article, Research Support, Non-U.S. Gov't
PubMed
29655662
DOI
10.1016/j.healun.2018.03.002
PII: S1053-2498(18)31383-4
Knihovny.cz E-resources
- Keywords
- HeartMate 3, INR management, LVAD, Rosendaal method, TTR, left ventricular assist device, reduced intensity anti-coagulation, time in therapeutic range,
- MeSH
- Anticoagulants administration & dosage adverse effects MeSH
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Pilot Projects MeSH
- Heart-Assist Devices * MeSH
- Prospective Studies MeSH
- Prosthesis Design MeSH
- Aged MeSH
- Heart Failure surgery MeSH
- Warfarin administration & dosage adverse effects MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Names of Substances
- Anticoagulants 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
References provided by Crossref.org
ClinicalTrials.gov
NCT03078374
