Left ventricular assist devices (LVADs) have been shown to prolong survival and improve quality of life, which is why they were approved a decade ago as destination therapy for advanced heart failure, not just a bridge to heart transplant.
The question raised in a new study published in JAMA Internal Medicine, however, is whether the devices offer the same mortality benefits in patients with both heart failure and end-stage renal disease (ESRD). Co-morbidity between the two conditions is common: The prevalence of heart failure is about 40% of ESRD patients, and 37% of them die from heart failure.
LVAD. (Source: Creative Commons)
To determine survival after use of the assist devices, researchers from the University of Washington in Seattle conducted an 11-year study of a nationally representative patient population of LVAD recipients. Results indicate that 81.9% of patients with ESRD prior to LVAD implantation died during follow-up vs 36.4% among patients without ESRD. After LVAD placement, the median time to death was 16 days for patients with ESRD vs. 2,125 days for those without ESRD.
Participants included Medicare beneficiaries after ESRD onset from 2003 to 2013; their records were linked with data from the United States Renal Data System (USRDS), a national registry for ESRD. Those patients, all of whom had undergone dialysis or a kidney transplant, were then compared to a 5% sample of Medicare beneficiaries without ESRD.
Patients without ESRD in the study were slightly older – average age 62.2 vs. 58.4 for those with ESRD --- and less likely to be male, 62.2% vs. 75.1%. During a median follow-up of 762 days (IQR, 92-3850 days), 127 patients (81.9%) with ESRD and 95 (36.4%) without died. The differences were dramatic, with more than half of patients with ESRD, 51.6%, compared with 11 4% of those without dying during the index hospitalization.
After adjusting for demographics, comorbidity and time period, the researchers determined that patients with ESRD had a sharply increased adjusted risk of death (hazard ratio, 36.3; 95% CI, 15.6-84.5), and that the first 60 days after LVAD placement were the most risky.
“Patients with ESRD at the time of LVAD placement had an extremely poor prognosis, with most surviving for less than 3 weeks,” study authors concluded. “This information may be crucial in supporting shared decision-making around treatments for advanced heart failure for patients with ESRD.”
The study points out that patients with ESRD are a unique population already receiving one form of chronic life support, adding that patients receiving maintenance dialysis are more likely than patients with other chronic illnesses to receive intensive medical care at the end of life.
Yet, a small subset of patients with ESRD survived for longer periods of time and some went on to receive a heart transplant, researchers state, raising the possibility that at least some patients with ESRD could benefit from LVADs.
“Recent studies demonstrate that end-of-life discussions for patients with LVADs and their family members, caregivers, and physicians are often challenging, particularly decisions about whether and when to deactivate these devices toward the end of life,” study authors stated.
“Our results may help to inform treatment decisions in patients with ESRD and heart failure who are contemplating LVAD placement. These patients should ideally be informed about the very poor prognosis of most patients with ESRD who receive an LVAD. In the context of each patients’ goals and values, this information should then factor into shared decision-making around LVAD placement.”