The Impact of Adverse Events on Functional Capacity and Quality of Life After HeartWare Ventricular Assist Device Implantation.

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Citation: ASAIO Journal. 67(10):1159-1162, 2021 10 01.PMID: 33927085Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Heart Failure | *Heart-Assist Devices | Heart Failure/su [Surgery] | Heart-Assist Devices/ae [Adverse Effects] | Humans | Quality of Life | Treatment Outcome | WalkingYear: 2021ISSN:
  • 1058-2916
Name of journal: ASAIO journal (American Society for Artificial Internal Organs : 1992)Abstract: Left ventricular assist devices (LVADs) improve quality of life (QoL) and functional capacity (FC) for patients with advanced heart failure. The association between adverse events (AEs) and changes in QoL and FC are unknown. Patients treated with the HeartWare ventricular assist device (HVAD) with paired 6-minute walk distance (6MWD, n = 263) and Kansas City Cardiomyopathy Questionnaires (KCCQ, n = 272) at baseline and 24 months in the ENDURANCE and ENDURANCE Supplemental Trial databases were included. Patients were stratified based upon occurrence of clinically significant AEs during the first 24 months of support and analyzed for the mean change in 6MWD and KCCQ. The impact of AE frequency on change in 6MWD and KCCQ from baseline to 24 months was evaluated. Of the AEs examined, only sepsis was associated with an improvement in 6MWD (109 m vs. 16 m, p = 0.002). Patients without improvement in 6MWD test from baseline to 24 months had significantly more AEs than those with FC improvement (p = 0.0002). Adverse events did not affect the KCCQ overall summary score. In this analysis, patients with fewer AEs had greater improvement in FC during the 24-month follow up. The frequency of AEs did not have a significant impact on QoL after LVAD implantation. Copyright (c) 2021 by the American Society for Artificial Internal Organs.All authors: Aaronson KD, Birks E, Boyce S, Itoh A, Milano CA, Mokadam N, Najjar SS, Pagani FD, Pamboukian S, Reid B, Rogers JG, Samsky MD, Slaughter MSOriginally published: ASAIO Journal. 2021 Apr 21Fiscal year: FY2022Fiscal year of original publication: FY2021Digital Object Identifier: Date added to catalog: 2021-06-07
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Journal Article MedStar Authors Catalog Article 33927085 Available 33927085

Left ventricular assist devices (LVADs) improve quality of life (QoL) and functional capacity (FC) for patients with advanced heart failure. The association between adverse events (AEs) and changes in QoL and FC are unknown. Patients treated with the HeartWare ventricular assist device (HVAD) with paired 6-minute walk distance (6MWD, n = 263) and Kansas City Cardiomyopathy Questionnaires (KCCQ, n = 272) at baseline and 24 months in the ENDURANCE and ENDURANCE Supplemental Trial databases were included. Patients were stratified based upon occurrence of clinically significant AEs during the first 24 months of support and analyzed for the mean change in 6MWD and KCCQ. The impact of AE frequency on change in 6MWD and KCCQ from baseline to 24 months was evaluated. Of the AEs examined, only sepsis was associated with an improvement in 6MWD (109 m vs. 16 m, p = 0.002). Patients without improvement in 6MWD test from baseline to 24 months had significantly more AEs than those with FC improvement (p = 0.0002). Adverse events did not affect the KCCQ overall summary score. In this analysis, patients with fewer AEs had greater improvement in FC during the 24-month follow up. The frequency of AEs did not have a significant impact on QoL after LVAD implantation. Copyright (c) 2021 by the American Society for Artificial Internal Organs.

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