Left Ventricular Assist Devices Pose Informed Consent Challenges
More patients are receiving left ventricular assist devices (LVADs), but informed consent is challenging.
“LVADs are indicated only for patients with severe, end-stage heart failure. These patients are often very sick, often in intensive care,” says Larry A. Allen, MD, MHS, professor of medicine and medical director of advanced heart failure at the University of Colorado Anschutz Medical Campus in Aurora.
Most patients learn about the the option of LVADs when they are facing the possibility of death, either from progressive heart failure into cardiogenic shock or from a major surgery. “Emotion is high, and biases of cognition are prevalent. The LVAD itself is usually foreign, with complex physiology and tradeoffs,” Allen says.
All these issues pose challenges to ethical decision-making and informed consent. “Patients and their families almost always have some time to consider their options,” Allen says.
One reason is that durable LVADs usually are put in stabilized patients, whereas unstable patients are treated with temporary devices. “Device implantation is expensive, and there is a preauthorization process with insurers,” Allen adds.
Additionally, LVADs are offered only at 180 specialized centers in the United States, all with a multidisciplinary team in place to educate the patient and obtain consent. “Ideally, patients and family are able to talk to many members of the team, and often even meet a patient who has an LVAD,” Allen says.
Device companies typically create educational materials, and LVAD teams give these to patients while presenting options. “One potential issue is that in fee-for-service care with private insurers, implantation of an LVAD is very lucrative,” Allen notes. “The potential for bias exists.”
To minimize this, clinicians use decision aids when LVAD is considered. (Editor’s Note: For an example of this aid, see one created by the Colorado Program for Patient Centered Decisions online at this link: http://bit.ly/2W2tPob.)
First, a group makes a formal decision to evaluate a patient for LVAD. “This is often signified by a team decision leading to a request for preauthorization from the health insurer for LVAD evaluation,” Allen says.
Next, the nursing coordinator for mechanical circulator support sets up a series of meetings with the patient and family for evaluation and education. That is usually when the decision aids are shared with the patient. “The decision aids set the stage for what is to come, including framing this as a decision,” Allen explains.
The decision aids help guide subsequent discussions with patients, according to a recent survey of 48 clinicians.1 The authors of another study conducted in six LVAD implanting centers from 2015 to 2017 found that patients who received pamphlet and video decision aids had substantially lower implantation rates of LVADs compared to a control group.2
LVAD patients are essentially reliant on the device for survival. “If the device is turned off, the vast majority of patients die within 20 minutes,” says Allen, who co-authored a recent paper on LVAD withdrawal.3
Many patients whose devices are deactivated are awake and alert. “Thus, discontinuation of care in this scenario feels very significant to clinicians, families, and patients,” Allen says.
Ethically, LVAD withdrawal sometimes is viewed as different from withdrawing other forms of life-sustaining treatment. “Among a small minority, there is a belief that LVAD withdrawal is closer to euthanasia because the LVAD, unlike intubation or vasopressors, is a long-term, durable form of support,” says Samuel D. Slavin, MD, who was the lead author on the Allen paper.3
Most ethicists believe LVAD withdrawal should be considered similarly to stopping other life-sustaining measures. “A good analogy might be the decision to stop hemodialysis,” says Slavin, an internal medicine resident at Massachusetts General Hospital.
Other investigators examined what end of life is like for patients with LVADs.4 “There has been significant effort placed on developing LVAD technology and expanding access, with relatively little inquiry into the inevitable end-of-life process,” says Colleen McIlvennan, DNP, MS, BSN, the study’s lead author and an assistant professor at University of Colorado Anschutz Medical Campus.
Trial and registry data have revealed causes and timing of death of patients with LVADs. “The main motivation for this study was to provide a more granular view of the process of death with an LVAD,” McIlvennan explains.
Of 18,733 patients implanted between 2008 and 2016, 4,916 were known to have died. “We found variability in patients’ causes of death over time, as well as their health-related quality of life,” McIlvennan observes.
Education on the end-of-life process should begin before LVAD implantation. “Although many patients and families may not want to hear this information or even remember the discussion, it should be an important part of decision-making,” McIlvennan says.
Rigorously developed educational materials, for clinicians as well as patients and families, are needed, McIlvennan offers. She and colleagues also found that of the LVAD patients who died, 76.9% died in the hospital. Most patients prefer to die outside the hospital.5
“The reasons for patients with LVADs dying in the hospital are likely multifactorial,” McIlvennan offers. These include clinicians’ low threshold to admit these patients, known complications associated with LVAD therapy, and poor understanding of patient preferences.
“We, as a community, need to focus on bolstering education and systems of care that address end-of-life needs in this population,” McIlvennan says.
- Matlock DD, McIlvennan CK, Thompson JS, et al. Decision aid implementation among left ventricular assist device programs participating in the DECIDE-LVAD stepped-wedge trial. Medical Decision Making 2020 (in press).
- Allen LA, McIlvennan CK, Thompson JS, et al. Effectiveness of an intervention supporting shared decision making for destination therapy left ventricular assist device: The DECIDE-LVAD randomized clinical trial. JAMA Intern Med 2018;178:520-529.
- Slavin SD, Allen LA, McIlvennan CK, et al. Left ventricular assist device withdrawal: Ethical, psychological, and logistical challenges. J Palliat Med 2020; Jan 2. doi: 10.1089/jpm.2019.0622. [Epub ahead of print].
- McIlvennan CK, Grady KL, Matlock DD, et al. End of life for patients with left ventricular assist devices: Insights from INTERMACS. J Heart Lung Transplant 2019;38:374-381.
- Cross SH, Warraich HJ. Changes in the place of death in the United States. N Engl J Med 2019;381:2369-2370.
Most patients learn about the the option of left ventricular assist devices when they are facing the possibility of death. Emotion is high, and biases of cognition are prevalent. These issues pose challenges to ethical decision-making and informed consent.
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