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

JOURNAL OF HEART AND LUNG TRANSPLANTATION

卷:37

Article

Netuka, Ivan¹  Ivak, Peter^1,2  Tucanova, Zuzana¹  Gregor, Stanislav³  Szarszoi, Ondrej¹  Sood, Poornima⁴  Crandall, Daniel⁴  Rimsans, Jessica⁵  Connors, Jean Marie⁶  Mehra, Mandeep R.⁷ 

[1] Inst Clin & Expt Med, Dept Cardiovasc Surg, Videnska 1958-9, Prague 4, Czech Republic

[2] Charles Univ Prague, Fac Med 3, Prague, Czech Republic

[3] Inst Clin & Expt Med, Dept Pharm, Prague, Czech Republic

[4] Abbott, Global Clin, Heart Failure, Burlington, MA USA

[5] Harvard Med Sch, Brigham & Womens Hosp, Dept Pharm, Boston, MA USA

[6] Harvard Med Sch, Brigham & Womens Hosp, Div Hematol, Boston, MA USA

[7] Harvard Med Sch, Brigham & Womens Hosp, Heart & Vasc Ctr, Boston, MA USA

关键词: HeartMate 3;    INR management;    left ventricular assist device;    LVAD;    reduced intensity anti-coagulation;    Rosendaal method;    TTR;    time in therapeutic range;   

DOI  :  10.1016/j.healun.2018.03.002

来源: Elsevier

【 摘 要 】

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 EvaluatioN To 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 [1NR] 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. (C) 2018 International Society for Heart and Lung Transplantation. All rights reserved.

【 授权许可】

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