Adverse Event Rates Change Favorably Over Time for Patients Bridged With the HeartWare Left Ventricular Assist Device.

MedStar author(s):
Citation: ASAIO Journal. 63(6):745-751, 2017 Nov/Dec.PMID: 28475561Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Heart-Assist Devices/ae [Adverse Effects] | Heart Failure/ep [Epidemiology] | Heart Failure/mo [Mortality] | Heart Failure/th [Therapy] | Heart Transplantation | Humans | Stroke/ep [Epidemiology] | Time FactorsYear: 2017Local holdings: Available online from MWHC library: 2000 - present, Available in print through MWHC library: 1999 - 2003ISSN:
  • 1058-2916
Name of journal: ASAIO journal (American Society for Artificial Internal Organs : 1992)Abstract: 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 bridge-to-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.All authors: Aaronson KD, Jeevanandam V, Kormos RL, Leadley K, Maltais S, McGee E Jr, Najjar SS, Pham DT, Slaughter MS, Teuteberg JJFiscal year: FY2017Digital Object Identifier: Date added to catalog: 2017-05-24
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Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 28475561 Available 28475561

Available online from MWHC library: 2000 - present, Available in print through MWHC library: 1999 - 2003

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 bridge-to-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.

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