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Mapping the Informed Consent Process for Left Ventricular Assist Devices.

Savitri E Fedson1,2, Kelly K MacKenzie1, Estevan D Delgado1

  • 1From the Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, Texas.

ASAIO Journal (American Society for Artificial Internal Organs : 1992)
|October 28, 2017
PubMed
Summary
This summary is machine-generated.

Informed consent documents for left ventricular assist device (LVAD) implantation vary widely, often omitting crucial details. A new model document improves disclosure and readability for patients and families considering LVADs.

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Area of Science:

  • Cardiology
  • Medical Ethics
  • Health Communication

Background:

  • Left ventricular assist device (LVAD) implantation involves complex ethical, practical, and medical considerations.
  • Informed consent documents (IC-Docs) are critical for patient understanding and decision-making regarding LVADs.

Purpose of the Study:

  • To analyze existing LVAD implantation IC-Docs for content, patient knowledge gaps, and readability.
  • To develop a model IC-Doc that enhances information disclosure and patient comprehension.

Main Methods:

  • A comprehensive analysis of 19 LVAD implantation IC-Docs from US programs.
  • Evaluation focused on medical/technical content, identified patient knowledge gaps, and document syntax.
  • Readability assessed using grade level.

Main Results:

  • Significant variation exists among IC-Docs, with many omitting key benefits and risks.
  • Most documents mentioned LVAD indications (e.g., bridge to transplant, destination therapy), but few specified patient applicability.
  • Palliative care alternatives and the possibility of device deactivation were inconsistently addressed; driveline infections and specific bleeding risks were rarely detailed.

Conclusions:

  • Current LVAD IC-Docs present substantial variability and information gaps.
  • A newly developed model IC-Doc demonstrates improved disclosure and readability, addressing identified patient knowledge deficits.
  • Optimizing IC-Docs is essential for informed decision-making in LVAD implantation.