This post was developed as part of the Heart Failure Awareness Week 2021 Heart Failure Top Innovations Countdown.
Larry A. Allen, MD, MHS, Professor of Medicine, Kenneth Poirier Chair, Associate Head for Clinical Affairs, Cardiology, Medical Director, Advanced Heart Failure - University of Colorado, School of Medicine
Daniel D. Matlock, MD, MPH, University of Colorado, School of Medicine
Jocelyn S. Thompson, MA, Research Project Manager, University of Colorado School of Medicine
Bryan C. Wallace, Research Project Manager, University of Colorado School of Medicine
With advances in medical technology, people with chronic disease are increasingly offered major surgeries and devices. Two examples of this are the left ventricular assist device (LVAD) and the implantable cardioverter defibrillator (ICD).
LVAD use is growing rapidly among people with end-stage heart failure. After open-heart surgery, patients live with a partial artificial heart until they can get a transplant or for the remainder of their lives. Although patients may live longer with an LVAD, it poses many risks, including stroke, serious infection, and bleeding, and comes with big lifestyle changes and the need for a dedicated family caregiver. Therefore, the decision whether or not to get an LVAD is often a difficult one, with some people deciding to get the LVAD and some deciding to pursue palliative care. Despite the difficulty of the decision, much of the information that was available to patients was essentially advertisements for marketing of the LVAD devices.
ICD use is increasing similarly for people with heart failure at risk of sudden cardiac death (SCD), with over 200,000 ICDs implanted annually in the US. For appropriate patients, ICDs result in roughly a 5% absolute increase in survival in the 5 years after implant. However, a number of potential clinical and quality of life threats do exist. ICDs require surgical implantation and regular follow up. Some patients have described an ICD shock as “getting kicked in the chest by a mule,” leading to have their ICDs removed for fear of repeated shocks. Inappropriate shocks can also occur with ICDs. Some studies suggest that patients with ICDs have more heart failure admissions, a lower quality of life - particularly if shocked by their device - and an increased incidence of anxiety, depression, and post-traumatic stress disorder. Furthermore, if not properly deactivated, ICDs can cause unnecessary suffering at the end of life. Overall, patients tend to overestimate the benefits of ICDs, underestimate the risks, and are underinformed about device deactivation.
To fill in these gaps, formal decision aids have been developed to help patients and their loved ones faced with the decision whether or not to undergo device surgeries. Some examples of these are the pamphlet and video decision aids systematically developed by the Colorado Program for Patient Centered Decisions (CPPCD) of the University of Colorado.
The LVAD decision aid includes an 8-page pamphlet and 26-minute video for patients and their caregivers, which were developed over several years and then tested through the DECIDE-LVAD clinical trial to see if they improved the quality of decision making. Six hospitals across the United States participated and enrolled patients and their caregivers considering LVAD treatment. Compared to those patients who received standard education, patients who received the decision aid had a greater knowledge about the LVAD and were more likely to make a decision about LVAD that reflected their health goals. Thus, the study showed that the use of the decision aid can help patients considering an LVAD improve the quality of decision making for this complex treatment.
The ICD decision aid includes pamphlets and videos for three decisions: initial ICD implant, ICD replacement, and cardiac resynchronization therapy with an ICD (CRT-D). These formal decision aids were developed over several years by an expert panel of patients and clinicians, to make sure that everyone’s needs were addressed. The intent of these decision aids is to inform patients and facilitate conversations with doctors. In a trial at three different Colorado sites, patients found the decision aids to be acceptable, unbiased, and would recommend them to others. Patients felt empowered to have time to review the information before a clinic visit, share with caregivers, stimulate questions for better conversations at a clinic visit, and reduce their anxiety after the visit. When the Centers for Medicare and Medicaid Services mandated in October 2018 that “a formal shared decision making encounter must occur between the patient and an independent physician…using an evidence-based decision tool on ICDs prior to initial ICD implantation,” they referenced the ICD decision aids by the CPPCD as their best example. The CPPCD continues to test and improve the effectiveness of the ICD decision aids in real-world settings with seven electrophysiology centers around the US through an ongoing trial with the National Institutes of Health.
The CPPCD also worked with the American College of Cardiology (ACC) to offer decision aids to assist people with heart failure who are considering medication options, left atrial appendage closure devices, or transcatheter aortic valve replacement. The LVAD and ICD decision aids are also available through the ACC, as well.
At the present time, 107 U.S. medical centers that implant LVADs in adults employ the DECIDE-LVAD evidence-based decision aids, with a goal to implement them at all 175 centers. The pamphlet has also since been translated into Spanish and French and adapted for Australia, and now these versions are widely used throughout the U.S., Canada, France and Australia.
The adoption of these evidence-based decision aids empowers patients to advocate for their own health and arm them with the knowledge and understanding behind some of the most critical decisions in their healthcare. They allow for shared decision-making between patients and their care teams, which serves as a more holistic approach to individual care.
All of the Colorado Program for Patient Centered Decisions (CPPCD) decision aid pamphlets and videos are free for any medical center, patient, or family to use at: https://patientdecisionaid.org.
The American College of Cardiology (ACC) decision aids can be found online at: https://www.cardiosmart.org/topics/decisions.
Disclaimer: The statements and views expressed in this post are those of the author and do not necessarily reflect the opinions or recommendations of the Heart Failure Society of America. Furthermore, HFSA does not endorse any medications or treatments discussed herein.