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Evaluation of low-intensity anti-coagulation with a fully magnetically levitated centrifugal-flow circulatory pump-the MAGENTUM 1 study

I. Netuka, P. Ivák, Z. Tučanová, S. Gregor, O. Szárszoi, P. Sood, D. Crandall, J. Rimsans, JM. Connors, MR. Mehra,

. 2018 ; 37 (5) : 579-586. [pub] 20180411

Language English Country United States

Document type Journal Article, Research Support, Non-U.S. Gov't

Persistent link   https://www.medvik.cz/link/bmc19045490

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.

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$a Netuka, Ivan $u Department of Cardiovascular Surgery, Institute for Clinical and Experimental Medicine, Prague, Czech Republic. Electronic address: ivan.netuka@ikem.cz.
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$a 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.
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$a Ivák, Peter $u Department of Cardiovascular Surgery, Institute for Clinical and Experimental Medicine, Prague, Czech Republic; Third Faculty of Medicine, Charles University, Prague, Czech Republic.
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$a Tučanová, Zuzana $u Department of Cardiovascular Surgery, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.
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$a Gregor, Stanislav $u Department of Pharmacy, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.
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$a Szárszoi, Ondrej $u Department of Cardiovascular Surgery, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.
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$a Sood, Poornima $u Global Clinical, Heart Failure, Abbott, Burlington, Massachusetts, USA.
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$a Crandall, Daniel $u Global Clinical, Heart Failure, Abbott, Burlington, Massachusetts, USA.
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$a Rimsans, Jessica $u Department of Pharmacy, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
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$a Connors, Jean Marie $u Division of Hematology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
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$a Mehra, Mandeep R $u Heart and Vascular Center, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
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