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Mapping the Informed Consent Process for Left Ventricular Assist Devices

Fedson, Savitri E.*,†; MacKenzie, Kelly K.*; Delgado, Estevan D.*; Abraham, Mackenzie N.*; Estep, Jerry D.; Blumenthal-Barby, Jennifer S.; Bruce, Courtenay R.*,‡

doi: 10.1097/MAT.0000000000000696
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Ethical, practical, and medical challenges affect decisions about left ventricular assist device (LVAD) implantation. The informed consent document (IC-Doc) is integral to the decision-making process and structures informed consent conversations. The objective of this study was to analyze IC-Docs to identify the information patients and their families receive about LVAD implantation to create a model IC-Doc. We requested IC-Doc for LVAD implantation from LVAD programs in the United States. We analyzed them in three areas: medical and technical content, patient knowledge gaps, and syntax. Nineteen IC-Docs representing all United Network of Organ Sharing regions were included. Seventeen (89.5%) mentioned the indications for LVAD implantation (bridge to transplant or destination therapy), and six indicated which category applied to the patient. Palliative care was mentioned as an alternative in nine (47.4%); no IC-Doc discussed nonsurgical palliative care. Eight forms (42.1%) specifically mentioned turning off the LVAD. Eighteen forms mention general bleeding, and four referred to long-term gastrointestinal bleeding. Two IC-Docs addressed driveline infections. One form was written at an 8th grade reading level. There is wide variation in LVAD IC-Docs and omission of some benefits and risks. We have written an IC-Doc that meets criteria for disclosure, fills many knowledge gaps, and has an acceptable readability score.

From the *Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, Texas

Michael E. DeBakey Veteran’s Affairs Medical Center, Houston, Texas

Debakey Heart and Vascular Center, Houston Methodist Hospital, Houston, Texas.

Submitted for consideration June 2017; accepted for publication in revised form September 2017.

This work was supported through a Patient-Centered Outcomes Research Institute (PCORI) Program Award (1306–01769).

Disclaimer: all statements in this report, including its findings and conclusions, are solely those of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute (PCORI) or Board of Governors or Methodology Committee.

Disclosure: Jerry D. Estep has receive honoraria and served as a consultant/medical advisor for St. Jude Medical. The remaining authors have no disclosures.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text, and links to the digital files are provided in the HTML and PDF versions of this article on the journal’s Web site (www.asaiojournal.com).

Correspondence: Savitri E. Fedson, Center for Medical Ethics and Health Policy, Department of Medicine, Baylor College of Medicine, One Baylor Plaza, Suite 310D, Houston, TX 77030. Email: Fedson@bcm.edu.

Copyright © 2018 by the American Society for Artificial Internal Organs