TY - JOUR
T1 - Treatment of device thrombus in the HeartWare HVAD
T2 - Success and outcomes depend significantly on the initial treatment strategy
AU - Stulak, John M.
AU - Dunlay, Shannon M.
AU - Sharma, Shashank
AU - Haglund, Nicholas A.
AU - Davis, Mary Beth
AU - Cowger, Jennifer
AU - Shah, Palak
AU - Masood, Faraz
AU - Aaronson, Keith D.
AU - Pagani, Francis D.
AU - Maltais, Simon
N1 - Publisher Copyright:
© 2015 International Society for Heart and Lung Transplantation.
PY - 2015/12/1
Y1 - 2015/12/1
N2 - 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.
AB - 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.
KW - HeartWare
KW - anti-coagulation
KW - device exchange
KW - lytic therapy
KW - pump thrombosis
KW - thrombus
KW - ventricular assist device
UR - http://www.scopus.com/inward/record.url?scp=84949817077&partnerID=8YFLogxK
U2 - 10.1016/j.healun.2015.10.020
DO - 10.1016/j.healun.2015.10.020
M3 - Article
C2 - 26681123
AN - SCOPUS:84949817077
SN - 1053-2498
VL - 34
SP - 1535
EP - 1541
JO - Journal of Heart and Lung Transplantation
JF - Journal of Heart and Lung Transplantation
IS - 12
ER -