PMID- 33927085
OWN - NLM
STAT- MEDLINE
DCOM- 20211125
LR  - 20230821
IS  - 1538-943X (Electronic)
IS  - 1058-2916 (Print)
IS  - 1058-2916 (Linking)
VI  - 67
IP  - 10
DP  - 2021 Oct 1
TI  - The Impact of Adverse Events on Functional Capacity and Quality of Life After 
      HeartWare Ventricular Assist Device Implantation.
PG  - 1159-1162
LID - 10.1097/MAT.0000000000001378 [doi]
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.
CI  - Copyright (c) ASAIO 2021.
FAU - Samsky, Marc D
AU  - Samsky MD
AD  - From the Duke University Medical Center, Durham, North Carolina.
FAU - Milano, Carmelo A
AU  - Milano CA
AD  - From the Duke University Medical Center, Durham, North Carolina.
FAU - Pamboukian, Salpy
AU  - Pamboukian S
AD  - University of Alabama at Birmingham, Birmingham, Alabama.
FAU - Slaughter, Mark S
AU  - Slaughter MS
AD  - University of Louisville, Louisville, Kentucky.
FAU - Birks, Emma
AU  - Birks E
AD  - University of Louisville, Louisville, Kentucky.
FAU - Boyce, Steven
AU  - Boyce S
AD  - Washington Hospital Center, Washington, DC.
FAU - Najjar, Samer S
AU  - Najjar SS
AD  - MedStar Washington Hospital Center, Washington, DC.
FAU - Itoh, Akinobu
AU  - Itoh A
AD  - Washington University, St Louis, Missouri.
FAU - Reid, Bruce
AU  - Reid B
AD  - Intermountain Medical Center, Murray, Utah.
FAU - Mokadam, Nahush
AU  - Mokadam N
AD  - University of Washington, Seattle, Washington.
FAU - Aaronson, Keith D
AU  - Aaronson KD
AD  - University of Michigan, Ann Arbor, Michigan.
FAU - Pagani, Francis D
AU  - Pagani FD
AD  - University of Michigan, Ann Arbor, Michigan.
FAU - Rogers, Joseph G
AU  - Rogers JG
AD  - From the Duke University Medical Center, Durham, North Carolina.
LA  - eng
GR  - T32 HL069749/HL/NHLBI NIH HHS/United States
PT  - Journal Article
PL  - United States
TA  - ASAIO J
JT  - ASAIO journal (American Society for Artificial Internal Organs : 1992)
JID - 9204109
SB  - IM
MH  - *Heart Failure/surgery
MH  - *Heart-Assist Devices/adverse effects
MH  - Humans
MH  - Quality of Life
MH  - Treatment Outcome
MH  - Walking
PMC - PMC8478694
MID - NIHMS1656617
COIS- 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.
EDAT- 2021/05/01 06:00
MHDA- 2021/11/26 06:00
PMCR- 2022/10/01
CRDT- 2021/04/30 06:12
PHST- 2021/05/01 06:00 [pubmed]
PHST- 2021/11/26 06:00 [medline]
PHST- 2021/04/30 06:12 [entrez]
PHST- 2022/10/01 00:00 [pmc-release]
AID - 00002480-202110000-00013 [pii]
AID - 10.1097/MAT.0000000000001378 [doi]
PST - ppublish
SO  - ASAIO J. 2021 Oct 1;67(10):1159-1162. doi: 10.1097/MAT.0000000000001378.