TY - JOUR
T1 - Drive-line infections and sepsis in patients receiving the HVAD system as a left ventricular assist device
AU - John, Ranjit
AU - Aaronson, Keith D.
AU - Pae, Walter E.
AU - Acker, Michael A.
AU - Hathaway, David R.
AU - Najarian, Kevin B.
AU - Slaughter, Mark S.
N1 - Publisher Copyright:
© 2014 International Society for Heart and Lung Transplantation. All rights reserved.
PY - 2014/10/1
Y1 - 2014/10/1
N2 - BACKGROUND: Drive-line infections and sepsis lead to significant morbidity and even mortality in patients with ventricular assist devices (VADs). The HeartWare HVAD system is unique compared with other VAD systems in that it has a thin, flexible drive-line and is implanted directly into the pericardial space without the need for a pump pocket. We reviewed 332 patients receiving the HVAD in the pivotal ADVANCE Bridge to Transplant (BTT) trial and Continued Access Protocol (CAP) to determine the incidence of drive-line infections and sepsis.METHODS: Summary statistics of outcomes and Kaplan-Meier freedom-from-event analyses were performed. The Cochran-Mantel-Haenszel test for homogeneity was used to determine whether there was any site effect on rates of either drive-line exit-site or sepsis infections.RESULTS: Drive-line exit-site infections occurred in 16.9% (56 of 332) of patients (0.25 event per patient-year[EPPY]). These infections were primarily treated with antibiotics and most occurred > 30 days post-implant (88%, or 66 of 75 drive-line infections).Sepsis occurred in 17.2% (57 of 332) of patients (0.23 EPPY), and sepsis events occurred more frequently 430 days post-implant (86%, or 60 of 70 sepsisevents). Of patients with sepsis, 17.5% (10 of 57) died due to sepsis-related neurologic events (7 of 10) and multisystem organ failure (2 of 10) and cardiopulmonary failure (1 of 10), where as there were no deaths related to drive-line infections. In addition, 17.5% (10 of 57) of patients had a stroke event while under treatment for sepsis (7 hemorrhagic and 3 ischemic strokes), and 3.5% (2 of 57 patients with sepsis) had a device exchange for VAD thrombus (4 days before and 1 day after sepsis diagnosis). Patients with drive-line infections or sepsis had a larger body mass index compared to those without infection (29.4 vs 27.6 kg/m2, p = 0.015),and were more frequently diabetic (43.7% vs 31.2%, p = 0.034). Although there was no negative impact on survival in patients with drive-line exit-site infections, there was a trend for reduced survival in patients with sepsis events when compared to those patients without sepsis.CONCLUSIONS: The incidence of drive-line infection and sepsis was low in patients receiving the HVAD pump. Despite a trend toward reduced survival in patients with sepsis events, the overall survival of patients with either drive-line infections or sepsis was excellent.
AB - BACKGROUND: Drive-line infections and sepsis lead to significant morbidity and even mortality in patients with ventricular assist devices (VADs). The HeartWare HVAD system is unique compared with other VAD systems in that it has a thin, flexible drive-line and is implanted directly into the pericardial space without the need for a pump pocket. We reviewed 332 patients receiving the HVAD in the pivotal ADVANCE Bridge to Transplant (BTT) trial and Continued Access Protocol (CAP) to determine the incidence of drive-line infections and sepsis.METHODS: Summary statistics of outcomes and Kaplan-Meier freedom-from-event analyses were performed. The Cochran-Mantel-Haenszel test for homogeneity was used to determine whether there was any site effect on rates of either drive-line exit-site or sepsis infections.RESULTS: Drive-line exit-site infections occurred in 16.9% (56 of 332) of patients (0.25 event per patient-year[EPPY]). These infections were primarily treated with antibiotics and most occurred > 30 days post-implant (88%, or 66 of 75 drive-line infections).Sepsis occurred in 17.2% (57 of 332) of patients (0.23 EPPY), and sepsis events occurred more frequently 430 days post-implant (86%, or 60 of 70 sepsisevents). Of patients with sepsis, 17.5% (10 of 57) died due to sepsis-related neurologic events (7 of 10) and multisystem organ failure (2 of 10) and cardiopulmonary failure (1 of 10), where as there were no deaths related to drive-line infections. In addition, 17.5% (10 of 57) of patients had a stroke event while under treatment for sepsis (7 hemorrhagic and 3 ischemic strokes), and 3.5% (2 of 57 patients with sepsis) had a device exchange for VAD thrombus (4 days before and 1 day after sepsis diagnosis). Patients with drive-line infections or sepsis had a larger body mass index compared to those without infection (29.4 vs 27.6 kg/m2, p = 0.015),and were more frequently diabetic (43.7% vs 31.2%, p = 0.034). Although there was no negative impact on survival in patients with drive-line exit-site infections, there was a trend for reduced survival in patients with sepsis events when compared to those patients without sepsis.CONCLUSIONS: The incidence of drive-line infection and sepsis was low in patients receiving the HVAD pump. Despite a trend toward reduced survival in patients with sepsis events, the overall survival of patients with either drive-line infections or sepsis was excellent.
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U2 - 10.1016/j.healun.2014.05.010
DO - 10.1016/j.healun.2014.05.010
M3 - Article
C2 - 25087103
AN - SCOPUS:84908143464
SN - 1053-2498
VL - 33
SP - 1066
EP - 1073
JO - Journal of Heart and Lung Transplantation
JF - Journal of Heart and Lung Transplantation
IS - 10
ER -