TY - JOUR
T1 - Adverse event rates change favorably over time for patients bridged with the heartware left ventricular assist device
AU - Maltais, Simon
AU - Aaronson, Keit H.D.
AU - Teuteberg, Jeffrey J.
AU - Slaughter, Mark S.
AU - Najjar, Samer S.
AU - Jeevanandam, Valluvan
AU - Pham, Duc T.
AU - McGee, Edwin C.
AU - Leadley, Katrin
AU - Kormos, Robert L.
N1 - Publisher Copyright:
© 2017 by the ASAIO.
PY - 2017
Y1 - 2017
N2 - The HeartWare Ventricular Assist System (HVAD) provides significant improvements in survival and quality of life, and here, we seek to evaluate temporal differences in the adverse event (AE) rates. Patients (n = 382) in the ADVANCE bridgeto-Transplant and continued access protocol trial were assessed for bleeding, cardiac arrhythmia, infection, ischemic and hemorrhagic stroke, and right heart failure during predetermined time periods (≤30, >30-180, >180-365, >365-730, >730-1,095 days) after HVAD implant. The Kaplan-Meier survival at 30 days, 6 months, 1, 2, and 3 years was 98%, 90%, 84%, 71%, and 63%, respectively. There were significantly fewer total AEs in days >30-180 (events per patient year [EPPY] = 5.34) compared with the first 30 days post HVAD implantation (EPPY = 30.36; p < 0.0001). The total AE rate in days >180-365 (EPPY = 4.09) was also significantly lower than the event rate in days >30-180 (EPPY = 5.34; p < 0.0001). Incidence of cardiac arrhythmias, infections, strokes, and right heart failure were highest immediately post implant and lower rates occurred after 6 months. After 1 year, all AEs exhibited stable rates that were comparable up to 3 years of support (all p > 0.05). This changing risk over time has clinically meaningful implications toward improving patient management. ASAIO Journal 2017; 63:745-751.
AB - The HeartWare Ventricular Assist System (HVAD) provides significant improvements in survival and quality of life, and here, we seek to evaluate temporal differences in the adverse event (AE) rates. Patients (n = 382) in the ADVANCE bridgeto-Transplant and continued access protocol trial were assessed for bleeding, cardiac arrhythmia, infection, ischemic and hemorrhagic stroke, and right heart failure during predetermined time periods (≤30, >30-180, >180-365, >365-730, >730-1,095 days) after HVAD implant. The Kaplan-Meier survival at 30 days, 6 months, 1, 2, and 3 years was 98%, 90%, 84%, 71%, and 63%, respectively. There were significantly fewer total AEs in days >30-180 (events per patient year [EPPY] = 5.34) compared with the first 30 days post HVAD implantation (EPPY = 30.36; p < 0.0001). The total AE rate in days >180-365 (EPPY = 4.09) was also significantly lower than the event rate in days >30-180 (EPPY = 5.34; p < 0.0001). Incidence of cardiac arrhythmias, infections, strokes, and right heart failure were highest immediately post implant and lower rates occurred after 6 months. After 1 year, all AEs exhibited stable rates that were comparable up to 3 years of support (all p > 0.05). This changing risk over time has clinically meaningful implications toward improving patient management. ASAIO Journal 2017; 63:745-751.
KW - Adverse events
KW - Left ventricular assist device
KW - Patient management
KW - Patient outcomes
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U2 - 10.1097/MAT.0000000000000585
DO - 10.1097/MAT.0000000000000585
M3 - Article
C2 - 28475561
AN - SCOPUS:85045565241
SN - 1058-2916
VL - 63
SP - 745
EP - 751
JO - ASAIO Journal
JF - ASAIO Journal
IS - 6
ER -