John M Stulak1, Shannon M Dunlay2, Shashank Sharma2, Nicholas A Haglund3, Mary Beth Davis3, Jennifer Cowger4, Palak Shah5, Faraz Masood6, Keith D Aaronson6, Francis D Pagani6, Simon Maltais2. 1. Division of Cardiovascular Surgery, Mayo Clinic College of Medicine, Rochester, Minnesota. Electronic address: stulak.john@mayo.edu. 2. Division of Cardiovascular Surgery, Mayo Clinic College of Medicine, Rochester, Minnesota. 3. University of Vanderbilt, Vanderbilt Heart and Vascular Center, Nashville, Tennessee. 4. Division of Cardiovascular Diseases, St. Vincent's Hospital, Indianapolis, Indiana. 5. Inova Fairfax Hospital, Inova Heart and Vascular Institute, Falls Church, Virginia. 6. Department of Cardiac Surgery, University of Michigan Health System, Ann Arbor, Michigan.
Abstract
BACKGROUND: Pump thrombosis is a major adverse event in patients supported with a left ventricular assist device (LVAD). Treatment approaches include device exchange, lytic therapy, or augmentation of anticoagulation or antiplatelet therapy. The optimal strategy in the HeartWare HVAD Ventricular Assist System (HeartWare, Framingham, MA) is uncertain, and because few large studies have examined differing treatment outcomes, we have reviewed findings from the Mechanical Circulatory Support Research Network registry. METHODS: Between March 2009 and August 2014, 175 patients (133 male) underwent implantation of the HeartWare HVAD at institutions that comprise the Mechanical Circulatory Support Research Network. Median age at implant was 59 years (range, 18-76 years). Follow-up was available in all patients for a median of 6 months (maximum, 61 months) and for a total of 163 patient-years of support. There were 36 pump thromboses (using Interagency Registry for Mechanically Assisted Circulatory Support criteria) in 21 patients for a total event rate of 0.22 events/patient-year of support; 13 patients had 1 event, 4 had 2, 2 had 3, 1 had 4, and 1 had 5. The median time to the first thrombosis was 6.4 months, and to each subsequent thrombosis was 4, 3, 2, and 2 months, respectively. Primary treatment success was defined as the patient remaining alive and within the first 30 days of the initial treatment be free from stroke, recurrence of pump thrombosis, device exchange, or urgent transplantation (United Network of Organ Sharing Status 1A). Medical treatment was defined as tissue plasminogen activator, heparin plus glycoprotein IIb/IIIa inhibitor, or heparin alone, not followed by surgical treatment within 72 hours. RESULTS: Initial medical treatment was used in 29 episodes (tissue plasminogen activator in 24, heparin alone in 4, and heparin plus glycoprotein IIb/IIIa in 1) and surgical (device exchange) in 7. Medical treatment was successful in 14 of 29 episodes (48%). Complications of medical treatment included hemorrhagic stroke in 6 patients (21%), need for urgent device exchange/transplant in 6 (21%), and death in 3 (10%). Surgical treatment was successful in all 7 patients (100%). No significant early complications or early deaths occurred after device exchange. CONCLUSIONS: In this large multicenter analysis, we observed that medical therapy, as the initial treatment strategy for HeartWare HVAD thrombosis, is associated with low success (48%) and a significant risk of hemorrhagic stroke (21%) and death (10%). However, initial treatment with device exchange was uniformly successful and not associated with significant early morbidity or death. Although the optimal treatment approach for HeartWare HVAD pump thrombosis remains undecided, these data do not support the routine use of medical therapy as an initial treatment strategy.
BACKGROUND: Pump thrombosis is a major adverse event in patients supported with a left ventricular assist device (LVAD). Treatment approaches include device exchange, lytic therapy, or augmentation of anticoagulation or antiplatelet therapy. The optimal strategy in the HeartWare HVAD Ventricular Assist System (HeartWare, Framingham, MA) is uncertain, and because few large studies have examined differing treatment outcomes, we have reviewed findings from the Mechanical Circulatory Support Research Network registry. METHODS: Between March 2009 and August 2014, 175 patients (133 male) underwent implantation of the HeartWare HVAD at institutions that comprise the Mechanical Circulatory Support Research Network. Median age at implant was 59 years (range, 18-76 years). Follow-up was available in all patients for a median of 6 months (maximum, 61 months) and for a total of 163 patient-years of support. There were 36 pump thromboses (using Interagency Registry for Mechanically Assisted Circulatory Support criteria) in 21 patients for a total event rate of 0.22 events/patient-year of support; 13 patients had 1 event, 4 had 2, 2 had 3, 1 had 4, and 1 had 5. The median time to the first thrombosis was 6.4 months, and to each subsequent thrombosis was 4, 3, 2, and 2 months, respectively. Primary treatment success was defined as the patient remaining alive and within the first 30 days of the initial treatment be free from stroke, recurrence of pump thrombosis, device exchange, or urgent transplantation (United Network of Organ Sharing Status 1A). Medical treatment was defined as tissue plasminogen activator, heparin plus glycoprotein IIb/IIIa inhibitor, or heparin alone, not followed by surgical treatment within 72 hours. RESULTS: Initial medical treatment was used in 29 episodes (tissue plasminogen activator in 24, heparin alone in 4, and heparin plus glycoprotein IIb/IIIa in 1) and surgical (device exchange) in 7. Medical treatment was successful in 14 of 29 episodes (48%). Complications of medical treatment included hemorrhagic stroke in 6 patients (21%), need for urgent device exchange/transplant in 6 (21%), and death in 3 (10%). Surgical treatment was successful in all 7 patients (100%). No significant early complications or early deaths occurred after device exchange. CONCLUSIONS: In this large multicenter analysis, we observed that medical therapy, as the initial treatment strategy for HeartWare HVAD thrombosis, is associated with low success (48%) and a significant risk of hemorrhagic stroke (21%) and death (10%). However, initial treatment with device exchange was uniformly successful and not associated with significant early morbidity or death. Although the optimal treatment approach for HeartWare HVAD pump thrombosis remains undecided, these data do not support the routine use of medical therapy as an initial treatment strategy.
Authors: Anthony E Peters; LaVone A Smith; Priscilla Ababio; Khadijah Breathett; Timothy L McMurry; Jamie L W Kennedy; Mohammad Abuannadi; James Bergin; Sula Mazimba Journal: J Card Fail Date: 2019-02-18 Impact factor: 5.712
Authors: Henrik Fox; Takayuki Gyoten; Sebastian V Rojas; Volker Lauenroth; Sabina Günther; René Schramm; Jan F Gummert; Michiel Morshuis Journal: Interact Cardiovasc Thorac Surg Date: 2022-06-15
Authors: Evgenij V Potapov; Christiaan Antonides; Maria G Crespo-Leiro; Alain Combes; Gloria Färber; Margaret M Hannan; Marian Kukucka; Nicolaas de Jonge; Antonio Loforte; Lars H Lund; Paul Mohacsi; Michiel Morshuis; Ivan Netuka; Mustafa Özbaran; Federico Pappalardo; Anna Mara Scandroglio; Martin Schweiger; Steven Tsui; Daniel Zimpfer; Finn Gustafsson Journal: Eur J Cardiothorac Surg Date: 2019-08-01 Impact factor: 4.191
Authors: Leonhard Wert; Jasmin S Hanke; Günes Dogan; Marcel Ricklefs; Anamika Chatterjee; Christina Feldmann; Issam Ismail; L Christian Napp; Axel Haverich; Jan D Schmitto Journal: J Thorac Dis Date: 2018-06 Impact factor: 2.895