Ivan Netuka1, Peter Ivák2, Zuzana Tučanová3, Stanislav Gregor4, Ondrej Szárszoi3, Poornima Sood5, Daniel Crandall5, Jessica Rimsans6, Jean Marie Connors7, Mandeep R Mehra8. 1. Department of Cardiovascular Surgery, Institute for Clinical and Experimental Medicine, Prague, Czech Republic. Electronic address: ivan.netuka@ikem.cz. 2. Department of Cardiovascular Surgery, Institute for Clinical and Experimental Medicine, Prague, Czech Republic; Third Faculty of Medicine, Charles University, Prague, Czech Republic. 3. Department of Cardiovascular Surgery, Institute for Clinical and Experimental Medicine, Prague, Czech Republic. 4. Department of Pharmacy, Institute for Clinical and Experimental Medicine, Prague, Czech Republic. 5. Global Clinical, Heart Failure, Abbott, Burlington, Massachusetts, USA. 6. Department of Pharmacy, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA. 7. Division of Hematology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA. 8. Heart and Vascular Center, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Abstract
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.
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.
Keywords:
HeartMate 3; INR management; LVAD; Rosendaal method; TTR; left ventricular assist device; reduced intensity anti-coagulation; time in therapeutic range
Authors: Noah Weingarten; Cindy Song; Amit Iyengar; David Alan Herbst; Mark Helmers; Danika Meldrum; Sara Guevara-Plunkett; Jessica Dominic; Pavan Atluri Journal: Indian J Thorac Cardiovasc Surg Date: 2022-09-21
Authors: Katherine C Michelis; Lin Zhong; Matthias Peltz; Ambarish Pandey; W H Wilson Tang; Anand Rohatgi; James B Young; Mark H Drazner; Justin L Grodin Journal: J Am Heart Assoc Date: 2020-07-10 Impact factor: 5.501