LVAD as Destination Therapy and Caregiver Burden

While improving the survival rates of patients diagnosed with end-stage heart failure has long been the underlying goal of mechanical support devices, in recent years research has supported the use of these devices to improve the quality of life for patients living with the disease. This effort was stimulated by the increasing prevalence of end-stage heart failure and its poor prognosis, as it affects an estimated 4.7 million Americans, with 550,000 new cases diagnosed annually.¹

The combined 5-year survival rate of patients with heart failure is approximately 50 percent, though the one-year mortality rate of patients diagnosed with advanced disease may exceed 50 percent.¹ Drug therapy has been shown to benefit patients who experience mild to moderate heart failure, with even some benefit given to those in the severe failure category, though their quality of life is extremely limited. For these severe heart failure patients, only a transplant will provide any substantial respite. However, with only approximately 3,000 donor organs available worldwide per year, there is little hope of receiving this benefit.¹ Because of this, we have seen a greater interest in alternative approaches to cardiac transplantation.

It is already well known that the LVAD results in longer life expectancy for patients living with severe heart failure. A recent study by Rose et al. shows that, for every 1,000 patients living with end-stage heart failure, the implantation of a left ventricular assist device could prevent at least 270 deaths annually, nearly 4 times that of beta-blockers or ACE inhibitors.²

Going a step further, the Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) trial explored whether the long-term use of the LVAD in patients with end-stage heart failure who are not eligible for cardiac transplantation would reduce mortality, with the study finding a reduced risk of mortality one year after implantation. On the basis of the REMATCH trial, the US Food and Drug Administration and the US Centers for Medicare & Medicaid Services approved permanent implantation of the left ventricular assist device as a destination therapy. There are roughly 250,000 LVAD implantation patients in the United States at this time.

While the overall findings seem to be positive, there have been some unintended side effects. While the more common issues of LVAD implantation are well documented (sepsis, neurological disorders, or device failure), very little attention has been paid to the unforeseen psychological effects and burden that the device may have on patients and their family’s quality of life.³

It is important to understand that quality of life domains include physical, psychological, social, spiritual, and financial well-being. During the REMATCH trial, patients reported higher QOL than those in the medication-only trials; however, these numbers still remained well below what would be considered healthy. As time went on, these reports became lower and lower due to a variety of factors. Patients described severe social restrictions due to not being able to travel far from home or the financial costs of living near a facility that had the capabilities to handle their particular needs.³

Moreover, caregivers noted that, while the patient often gave informed consent to treatment by the device, families were often not told the extent of their involvement or what their expectations were. Caregivers require both a high level of awareness and education about the LVAD in order to detect early complications and troubleshoot device malfunctions. It is not uncommon for them to worry more about device-related problems than the patients themselves. A vast majority of device malfunctions occur in the home, creating anxiety for caregivers who have been informally recruited to provide continuous care.³ However, this should not be taken as an argument against the use of LVADs as a bridge to destination therapy. Instead, providers should be urged to consider more than just the physical repercussions of the therapy and find ways to support the psychological deficits that both patients and their families may face in the coming months to years after the decision to undergo LVAD therapy.

Questions to Consider:

1. As a community healthcare provider, what resources do you feel are available to assist patients following destination LVAD therapy?
2. Should patients be discharged with mandatory psychotherapy orders?
3. What role, if any, would community paramedicine play in this scenario?

References

1. Bytyçi I, Bajraktari G. Mortality in heart failure patients. Anatolian Journal of Cardiology. 2015; 1: 63–68. https://doi.org/10.5152/akd.2014.5731
2. Rose E, et al. For the Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) Study Group, Author Affiliations From the College of Physicians and Surgeons Long-Term Use of a Left Ventricular Assist Device for End-Stage Heart Failure. New England Journal of Medicine. 2001; 345:1435-1443.
   DOI: 10.1056/NEJMoa012175
3. Rizzieri AG, Verheijde JL, Rady MY, et al. Ethical challenges with the left ventricular assist device as a destination therapy. Philos Ethics Humanit Med. 2008; 3: 20. https://doi.org/10.1186/1747-5341-3-20

Andrew R. Ross—MHA, NRP—has worked in the EMS industry as a paramedic for 19 years. He is a lead educator at Careercert and has over a decade of experience in EMS education and management. Andrew currently works full-time as the lead faculty instructor in his local community college’s EMS program. As an education advocate, Andrew recently earned his master’s in healthcare administration from the University of Scranton. He is married and has 2 daughters.