The PALL-VAD Study: Palliative Care Intervention to Improve Health Related Quality of Life for Patients With Heart Failure on Long-Term LVAD Support: A Pilot, Prospective, Randomized Trial

SPECIFIC AIMS

Approximately 6 million adults in the United States carry a diagnosis of heart failure (HF) and the prevalence is expected to rise to 8 million by 2030. About 5% (300,000) HF patients per year develop end-stage or advanced heart failure (AHF). Mortality rates are high once a patient is diagnosed with AHF, with median survival of only one year. Only two therapies have demonstrated survival and quality of life benefit for AHF: heart transplantation (HT) and left ventricular assist device (LVAD). A significant proportion of patients with AHF are not eligible for HT, which remains a scarce resource with demand greatly outstripping donor supply. The advent of LVAD therapy has thus transformed the care of patients with AHF who cannot receive HT. Over 25,000 patients received LVADs in the period from 2010 to 2019. A majority of LVADs are implanted with intention of being long-term ("destination") therapy. Therefore, the number of patients living on long-term LVAD (LT-LVAD) therapy, (defined as patients not anticipated to be able to undergo HT due to nonmodifiable factors), continues to increase every year. As these patients experience age-related diseases such as cancer and dementia, their needs for symptom management and advance care planning will increase over time. Palliative care can play a major role in improving HRQoL for these patients.

Though patients with LVADs have improved survival compared to those medically managed, they experience unique LVAD-related harms that impact quality of life. Palliative care is a subspecialty with a crucial role in the care of HF patients, focused on improvement of quality of life and reduction of suffering in patients with serious illness throughout their disease trajectory. The Palliative Care in Heart Failure (PAL-HF) trial demonstrated that patients who received outpatient palliative care had consistent and significant improvements in HRQoL, depression, anxiety, and spiritual well-being scales compared to patients receiving usual care. However, no studies to date have examined the role or impact of palliative care in the LT-LVAD population.

Taken together, these studies highlight major gaps and opportunities to better understand factors associated with HRQoL in LT-LVAD patients and design interventions to improve their HRQoL. The investigators hypothesize that palliative care specialists can significantly improve HRQoL for all LT-LVAD patients, with the additional benefit of mitigating disparities in HRQoL among vulnerable populations.

The investigators seek to address these gaps and test these hypotheses in a study at two large AHF therapies centers in the mid-Atlantic region-MedStar Washington Hospital Center and Inova Schar Heart and Vascular Institute, which combined will enhance diversity, patient recruitment and study team expertise. The study team will consist of AHF and palliative care representation and leadership at both institutions to ensure success in studying the following aims: