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      Thrombosis during off pump LVAD placement in a patient with heparin induced thrombocytopenia using bivalirudin

      case-report

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          Abstract

          Here we present our attempt at off pump HeartMate II left ventricular assist device (LVAD) implantation using the anticoagulant bivalirudin in a patient with heparin induced thrombocytopenia, which resulted in thrombosis within the LVAD device. This required that our procedure be converted to on pump, and a new HeartMate II LVAD device to be implanted. In our view, this thrombotic event may have been caused by a number of factors that include bivalirudin’s (1) short half-life of about 20 minutes, (2) decreased activity with blood stasis, (3) inability to prevent clot propagation, and (4) uncertainty with real-time monitoring of therapeutic levels. To prevent future thrombotic events, it may be beneficial to immediately deair the LVAD device prior to the coring of the left ventricle during off pump LVAD placement. In addition, a solution other than blood may be used for priming. If blood is used for priming of the LVAD device, the duration of blood stasis should not exceed 20 minutes when bivalirudin is being used for anticoagulation. Furthermore, this case emphasizes the importance of having a backup LVAD device available and ready to use during surgical procedures.

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          A comparison of bivalirudin to heparin with protamine reversal in patients undergoing cardiac surgery with cardiopulmonary bypass: the EVOLUTION-ON study.

          Bruce D. Spiess, H David McCarthy, Jessica R Kirshner … (2006)
          Unfractionated heparin and its antidote, protamine sulfate, allow for rapid and reversible anticoagulation during cardiac surgery with cardiopulmonary bypass, yet limitations exist, including a variable dose-response, dependence on a cofactor for anticoagulant effect, and antigenic potential. This trial was performed to evaluate the safety and efficacy of bivalirudin as an alternative to heparin with protamine reversal in on-pump cardiac surgery. We conducted a randomized, open-label, multicenter trial comparing heparin with protamine reversal to bivalirudin in patients undergoing cardiac surgery with cardiopulmonary bypass. The primary objective was to demonstrate comparable rates of in-hospital procedural success defined as freedom from death, Q-wave myocardial infarction, stroke, or repeat revascularization. Twenty-one institutions enrolled 101 patients randomized to bivalirudin and 49 patients to heparin treatment. The primary end point of procedural success was not significantly different between the bivalirudin arm and the heparin/protamine arms at 7 days, 30 days, or 12 weeks' follow-up. Adequate anticoagulation was achieved in all patients. Secondary end points including mortality, 24-hour blood loss, overall incidence of transfusions, and duration of surgery were similar between the two arms. Bivalirudin is a safe and effective anticoagulant for patients undergoing a wide range of cardiac surgical procedures with cardiopulmonary bypass. Procedural success rates with bivalirudin were similar to rates in patients receiving heparin anticoagulation, with no difference in mortality. Avoidance of blood stasis and attention to the intraoperative medical management of patients is critical for successful use of bivalirudin during cardiopulmonary bypass.
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            Bivalirudin during cardiopulmonary bypass in patients with previous or acute heparin-induced thrombocytopenia and heparin antibodies: results of the CHOOSE-ON trial.

            H David McCarthy, Maartje A Köster, N Smedira … (2007)
            The coronary artery bypass grafting (CABG) heparin-induced thrombocytopenia thrombosis syndrome (HITTS) on- and off-pump safety and efficacy (CHOOSE-ON) trial was designed as a safety and efficacy trial of bivalirudin for use in anticoagulation during cardiopulmonary bypass (CPB) in patients with confirmed or suspected HIT and (or) antiplatelet factor 4/heparin (anti-PF4/H) antibodies. In an open-label, multicenter trial, 50 patients were enrolled prospectively. The primary study endpoint was in-hospital acute procedural success, defined as the absence of death, Q-wave myocardial infarction (MI), repeat operation for coronary revascularization, and stroke at day seven after surgery or hospital discharge, whichever occurred first. The secondary study endpoints were procedural success, defined as the absence of death, Q-wave MI, repeat operation for coronary revascularization, and stroke, at 30 days and 12 weeks after surgery. Perioperative blood loss, transfusions, and the incidence of major bleeding events were also captured. There were 49 patients treated with bivalirudin of which 43 had acute HIT and thrombosis syndrome (HITTS) with antibodies at time of surgery. Procedural success in-hospital or at 7 days was achieved in 46 (94%) patients. At day 30 procedural success was achieved in 42 (86%) patients, and after 12 weeks in 40 (82%) patients. Mean intraoperative blood loss was 575 +/- 524 mL, and mean 24-hour postoperative blood loss was 998 +/- 595 mL. Forty-one (84%) patients received transfusions before day 7 or discharge with a mean of 5.6 +/- 3.8 units of red blood cells, 8.6 +/- 7.2 units of platelets, and 6.0 +/- 4.7 units of fresh frozen plasma. No differences in outcome among bivalirudin-treated patients were observed between those in the overall group and those with moderately impaired renal function (n = 10). The current investigation expands the experience of safe and effective anticoagulation with bivalirudin during CPB to patients with confirmed or suspected HIT and anti-PF4/H antibodies, including in the setting of impaired renal function.
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              Bivalirudin and post-cardiotomy ECMO: a word of caution

              Marco Ranucci (2012)
              Bivalirudin has been proposed as the sole anticoagulant in patients under extracorporeal membrane oxygenation (ECMO) or cardiopulmonary bypass. Owing to the pharmacodynamic properties of bivalirudin, areas of blood stagnation should be carefully avoided in order to limit the risk of thrombosis. The ECMO circuit has no reservoir and is usually devoid of blood stagnation areas. Conversely, under some circumstances, intracardiac blood stagnation areas may exist. In this case, there is a potential risk for the spontaneous formation of an intracardiac thrombus. We suggest that, under bivalirudin anticoagulation, a minimal degree of intracardiac blood flow with left heart valve movement is allowed.
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                Author and article information

                Contributors
                Hamdy Awad
                Richard Bryant
                Obaid Malik
                Galina Dimitrova
                Chittoor Bhaskar Sai-Sudhakar
                Journal
                Journal ID (nlm-ta): J Cardiothorac Surg
                Journal ID (iso-abbrev): J Cardiothorac Surg
                Title: Journal of Cardiothoracic Surgery
                Publisher: BioMed Central
                ISSN (Electronic): 1749-8090
                Publication date Collection: 2013
                Publication date (Electronic): 29 April 2013
                Volume: 8
                Page: 115
                Affiliations
                [1 ]Department of Anesthesiology, The Ohio State University Wexner Medical Center, Columbus, OH, USA
                [2 ]The Ohio State University College of Medicine, Columbus, OH, USA
                [3 ]The Ohio State University Wexner Medical Center, Columbus, OH, USA
                Article
                Publisher ID: 1749-8090-8-115
                DOI: 10.1186/1749-8090-8-115
                PMC ID: 3646705
                PubMed ID: 23628179
                SO-VID: fd6e66c9-e2b2-4e9d-a43b-e9b1ba5fc2b2
                Copyright © Copyright © 2013 Awad et al.; licensee BioMed Central Ltd.
                License:

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Date received : 22 July 2012
                Date accepted : 16 April 2013
                Categories
                Subject: Case Report

                ScienceOpen disciplines: Surgery
                Keywords: heartmate ii,left ventricular assist device,lvad,bivalirudin,stasis,pharmacology,off pump,heparin induced thrombocytopenia,hitt
                Data availability:
                ScienceOpen disciplines: Surgery
                Keywords: heartmate ii, left ventricular assist device, lvad, bivalirudin, stasis, pharmacology, off pump, heparin induced thrombocytopenia, hitt

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