Jason N Katz1, Robert M Adamson2, Ranjit John3, Antone Tatooles4, Kartik Sundareswaran5, Faouzi Kallel5, David J Farrar5, Ulrich P Jorde6. 1. Division of Cardiology, University of North Carolina Center for Heart and Vascular Care, Chapel Hill, North Carolina. Electronic address: katzj@med.unc.edu. 2. the Division of Cardiothoracic Surgery, Sharp Memorial Hospital, San Diego, California. 3. the Division of Cardiothoracic Surgery, University of Minnesota, Minneapolis, Minnesota. 4. the Division of Cardiothoracic Surgery, Advocate Christ Medical Center, Oak Lawn, Illinois. 5. Thoratec Corporation, Pleasanton, California. 6. the Division of Cardiology, Montefiore Medical Center/Albert Einstein College of Medicine, New York, New York.
Abstract
BACKGROUND: Patients with bleeding complications during left ventricular assist device (LVAD) support often require a reduction in the recommended warfarin plus aspirin regimen. To characterize those who can be safely managed with a reduced anti-thrombotic strategy, the TRACE (STudy of Reduced Anti-Coagulation/Anti-platelEt Therapy in Patients with the HeartMate II LVAS) study was initiated in the United States (U.S.) and Europe. METHODS: The TRACE U.S. arm enrolled HeartMate II (HMII; Thoratec) outpatients on a regimen of reduced anti-thrombotic therapy (RT), defined as vitamin K antagonist (warfarin) only, aspirin only, or no anti-thrombotic agent. The indication for RT, changes in anti-thrombotic therapies, and patient outcomes after RT were documented. Results for patients reaching 12 months or outcome are presented here. RESULTS: Between April 2012 and June 2013, 100 HMII outpatients (85% men) on RT (median age 64.5 [interquartile range, 32, 82] years, 61% with ischemic etiology, 69% destination therapy) were enrolled from 9 U.S. sites. The primary reason for RT initiation was in response to a bleeding event (82%). Pharmacotherapy at RT initiation included warfarin only (38%), aspirin only (28%), or no anti-thrombotic agent (34%). Freedom from ischemic stroke at 1 year was 93.8% ± 2.5%, and freedom from device thrombosis was 92.7% ± 2.7%. Despite RT, a subsequent bleeding event occurred in 52%. CONCLUSIONS: Reducing anti-thrombotic therapies in response to bleeding among HMII patients was achievable but may be associated with a higher risk for device thrombosis. Furthermore, despite an RT strategy, bleeding often will persist in those prone to such events.
BACKGROUND:Patients with bleeding complications during left ventricular assist device (LVAD) support often require a reduction in the recommended warfarin plus aspirin regimen. To characterize those who can be safely managed with a reduced anti-thrombotic strategy, the TRACE (STudy of Reduced Anti-Coagulation/Anti-platelEt Therapy in Patients with the HeartMate II LVAS) study was initiated in the United States (U.S.) and Europe. METHODS: The TRACE U.S. arm enrolled HeartMate II (HMII; Thoratec) outpatients on a regimen of reduced anti-thrombotic therapy (RT), defined as vitamin K antagonist (warfarin) only, aspirin only, or no anti-thrombotic agent. The indication for RT, changes in anti-thrombotic therapies, and patient outcomes after RT were documented. Results for patients reaching 12 months or outcome are presented here. RESULTS: Between April 2012 and June 2013, 100 HMII outpatients (85% men) on RT (median age 64.5 [interquartile range, 32, 82] years, 61% with ischemic etiology, 69% destination therapy) were enrolled from 9 U.S. sites. The primary reason for RT initiation was in response to a bleeding event (82%). Pharmacotherapy at RT initiation included warfarin only (38%), aspirin only (28%), or no anti-thrombotic agent (34%). Freedom from ischemic stroke at 1 year was 93.8% ± 2.5%, and freedom from device thrombosis was 92.7% ± 2.7%. Despite RT, a subsequent bleeding event occurred in 52%. CONCLUSIONS: Reducing anti-thrombotic therapies in response to bleeding among HMII patients was achievable but may be associated with a higher risk for device thrombosis. Furthermore, despite an RT strategy, bleeding often will persist in those prone to such events.
Authors: Omar Saeed; Paolo C Colombo; Mandeep R Mehra; Nir Uriel; Daniel J Goldstein; Joseph Cleveland; Jean M Connors; Samer S Najjar; Nahush A Mokadam; Aditya Bansal; Daniel L Crandall; Poornima Sood; Ulrich P Jorde Journal: J Heart Lung Transplant Date: 2020-03-20 Impact factor: 10.247
Authors: Asia McDavid; Kelly MacBrair; Sitaramesh Emani; Lianbo Yu; Peter H U Lee; Bryan A Whitson; Brent C Lampert; Riddhima Agarwal; Ahmet Kilic Journal: Interact Cardiovasc Thorac Surg Date: 2018-01-01