Association of Novel Ventricular Assist Device Self-report Measures With Overall Health-Related Quality of Life

Kathleen L. Grady*, James L. Burns, Larry A. Allen, Josef Stehlik, Jeffrey Teuteberg, Colleen K. McIlvennan, James K. Kirklin, David G. Beiser, Jo Ann Lindenfeld, Quin E. Denfeld, Christopher S. Lee, Michael Kiernan, David Cella, Liviu Klein, Mary Norine Walsh, Bernice Ruo, Eric Adler, Jonathan Rich, Duc Thinh Pham, Clyde W YancyCatherine Murks, Katy Bedjeti, Elizabeth A. Hahn

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Few study authors examined factors influencing health-related quality of life (HRQOL) early after left ventricular assist device (LVAD) implantation. Objective: The purpose of this study was to determine whether 5 novel self-report measures and other variables were significantly associated with overall HRQOL at 3 months after LVAD surgery. Methods: Patients were recruited between October 26, 2016, and February 29, 2020, from 12 US sites. Data were collected before LVAD implantation and at 3 months post LVAD implantation. Overall HRQOL measures included the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) overall summary score (OSS) and EuroQol 5-dimension- 3L visual analog scale. Potential factors associated with overall HRQOL included 5 novel self-report measures (Satisfaction with Treatment, Being Bothered by VAD Self-care and Limitations, VAD Team Communication, Self-efficacy regarding VAD Self-care, and Stigma), and demographic and clinical characteristics. Statistics included regression analyses. Results: Of enrollees, 242 completed self-report measures at baseline, and 142 completed measures 3 months postoperatively. Patients were 55 ± 13 years old, with 21% female, 24% non-White, 39% high school or lower educated, and 47% destination therapy. Using the KCCQ-12 OSS, higher Satisfaction with Treatment was associated with a higher KCCQ-12 OSS; Being Bothered by VAD Self-care and Limitations, high school or lower education, chest incision pain, cardiac dysrhythmias within 3 postoperative months, and peripheral edema were associated with a worse KCCQ-12 OSS (R2 = 0.524). Factors associated with a worse 3-month EuroQol 5-dimension-3L visual analog scale were female sex, adverse events within 3 months post implantation (cardiac dysrhythmias, bleeding, and venous thrombosis), and chest incision pain (R2 = 0.229). No factors were associated with a higher EuroQol 5-dimension-3L visual analog scale score at 3 months. Conclusions: Two novel measures, demographics, postimplantation adverse events, and symptoms were associated with post-LVAD KCCQ-12 OSS early after surgery.

Original languageEnglish (US)
Article number10.1097/JCN.0000000000001129
JournalJournal of Cardiovascular Nursing
DOIs
StateAccepted/In press - 2024

Funding

K.L.G. received National Institutes of Health (NIH) grants (National Institute on Aging and National Heart, Lung, and Blood Institute) and payment of room reservation by NIH as faculty at the 10-day seminar, and served as a lecturer (registration fees paid for meetings: Heart Failure Society of America, American Heart Association, International Society for Heart and Lung Transplantation, American College of Cardiology, and STS Intermacs). L.A.A. is a consultant for ACI Clinical, Boston Scientific (and on the Steering Committee), Cytokinetics (and on the Publications Committee), UpToDate (and a writer), and Quidel. J.S. received grants from Natera and Merck and a consultant for Medtronic, Natera, and TransMedics. J.T. is a consultant for Abbott, the Advisory Board of Abiomed, CareDx, and Takeda, and a lecturer for CareDx, Cytokinetics, and Paragonix. J.K.K. has intellectual properties for IT software development in registry database design developed at and licensed from the University of Alabama at Birmingham; is chair of DSMB for Xeltis cardiac conduit clinical trial, chair of DSMB for Carmat TAH clinical trial, and president of the World Society for Pediatric and Congenital Heart Surgery; supported by Kirklin Solutions Co. database development and analytics (20% ownership; no current stock options); and received partial salary support as Director of the Data Center for STS Intermacs/Pedimacs (no payments for any of these roles related to this publication). J.L. received personal fees from Abbott and Edwards. Q.E.D. received a grant from NIH/National Institute of Nursing Research. M.K. is part of the Steering Committee \u2013 Medtronic clinical trial and received speaking honoraria from Medtronic. E.A. received personal fees from Abbott, Medtronic, Lexeo Therapeutics, Rocket Pharmaceuticals, and AstraZeneca. D.T.P. received personal fees for the role of surgical advisor/consultant for Abiomed, Abbott, and Medtronic. C.Y. has spousal employment at Abbott Labs, Inc. This work was sponsored by the National Institutes of Health, National Heart Lung and Blood Institute, \u201CMechanical Circulatory Support: Measures of Adjustment and Quality of Life\u201D (R01HL130502, K.L.G. and E.A.H. [co-principal investigators]).

Keywords

  • mechanical circulatory support
  • patient-reported outcomes
  • quality of life
  • ventricular assist device

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Advanced and Specialized Nursing

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