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

Marc D. Samsky; Carmelo A. Milano; Salpy Pamboukian; Mark S. Slaughter; Emma Birks; Steven Boyce; Samer S. Najjar; Akinobu Itoh; Bruce Reid; Nahush Mokadam; Keith D. Aaronson; Francis D. Pagani; Joseph G. Rogers

doi:10.1097/MAT.0000000000001378

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

Marc D. Samsky, Carmelo A. Milano, Salpy Pamboukian, Mark S. Slaughter, Emma Birks, Steven Boyce, Samer S. Najjar, Akinobu Itoh, Bruce Reid, Nahush Mokadam, Keith D. Aaronson, Francis D. Pagani, Joseph G. Rogers

Research output: Contribution to journal › Article › peer-review

1 Scopus citations

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.

Original language	English
Pages (from-to)	1159-1162
Number of pages	4
Journal	ASAIO Journal
Volume	67
Issue number	10
DOIs	https://doi.org/10.1097/MAT.0000000000001378
State	Published - Oct 1 2021

Bibliographical note

Publisher Copyright:
© 2023 by the Association of Bone and Joint Surgeons.

Funding

The ENDURANCE clinical trial program was sponsored by HeartWare (now Medtronic). Statistical support for this article was provided by Medtronic. The authors had access to all the data and are responsible for critical review, writing, and content control. Disclosure: M.D.S. received salary supported from NIH T32 training grant (HL069749). M.S.S. received research grant funding from Heartware/Medtronic. N.M. has served as a consultant to Abbott, Medtronic, SynCardia, and Carmat. The other authors have no conflicts of interest to report.

Funders	Funder number
Medtronic (formerly HeartWare)
National Institutes of Health (NIH)	HL069749
National Institutes of Health (NIH)
Medtronic

Keywords

adverse events
left ventricular assist device
patient-centered outcomes

ASJC Scopus subject areas

Bioengineering
Biophysics
Biomedical Engineering
Biomaterials

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10.1097/MAT.0000000000001378

Cite this

Samsky, M. D., Milano, C. A., Pamboukian, S., Slaughter, M. S., Birks, E., Boyce, S., Najjar, S. S., Itoh, A., Reid, B., Mokadam, N., Aaronson, K. D., Pagani, F. D., & Rogers, J. G. (2021). The Impact of Adverse Events on Functional Capacity and Quality of Life After HeartWare Ventricular Assist Device Implantation. ASAIO Journal, 67(10), 1159-1162. https://doi.org/10.1097/MAT.0000000000001378

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title = "The Impact of Adverse Events on Functional Capacity and Quality of Life After HeartWare Ventricular Assist Device Implantation",

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.",

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Samsky, MD, Milano, CA, Pamboukian, S, Slaughter, MS, Birks, E, Boyce, S, Najjar, SS, Itoh, A, Reid, B, Mokadam, N, Aaronson, KD, Pagani, FD & Rogers, JG 2021, 'The Impact of Adverse Events on Functional Capacity and Quality of Life After HeartWare Ventricular Assist Device Implantation', ASAIO Journal, vol. 67, no. 10, pp. 1159-1162. https://doi.org/10.1097/MAT.0000000000001378

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T1 - The Impact of Adverse Events on Functional Capacity and Quality of Life After HeartWare Ventricular Assist Device Implantation

AU - Samsky, Marc D.

AU - Milano, Carmelo A.

AU - Pamboukian, Salpy

AU - Slaughter, Mark S.

AU - Birks, Emma

AU - Boyce, Steven

AU - Najjar, Samer S.

AU - Itoh, Akinobu

AU - Reid, Bruce

AU - Mokadam, Nahush

AU - Aaronson, Keith D.

AU - Pagani, Francis D.

AU - Rogers, Joseph G.

PY - 2021/10/1

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N2 - 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.

AB - 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.

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

Abstract

Bibliographical note

Funding

Keywords

ASJC Scopus subject areas

Access to Document

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