For patients with advanced heart failure, left ventricular assist devices (LVADs) are used as a bridge to heart transplant as well as destination therapy to prolong survival and improve quality of life. In results of the REMATCH (Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure) trial, compared with medical therapy alone, survival was improved with placement of an LVAD. The US FDA approved the use of LVADs as destination therapy for patients with advanced heart failure in 2008, creating a pathway for expansion of the use of these devices.
In patients with end-stage renal disease (ESRD), the prevalence of heart failure is ~40%; 37% of patients with ESRD die from heart failure. There are few data available on outcomes among recipients of LVADS with kidney disease; those studies that have been conducted focused on patients with early stages of kidney disease, including those not receiving maintenance dialysis and on patients with acute kidney injury (AKI); patients with ESRD have not been well represented in these trials. Nisha Bansal, MD, and colleagues recently conducted a trial designed to compare national trends in the utilization and outcomes following LVAD placement among patients with ESRD with those in patients without ESRD. Results were reported online in JAMA Internal Medicine [doi:10.1001/jamainternmed.2017.4831].
The study defined ESRD as having received maintenance dialysis or a kidney transplant at the time of LVAD placement. The researchers utilized data from the United States Renal Data System (USRDS) linked to Medicare claims to identify a cohort of beneficiaries who received their first LVAD between 2003 and 2013. The USRDS identifies an individual as having ESRD when a physician certifies the disease on the Centers for Medicare & Medicaid Services Medical Evidence form, or when there is other evidence that the patient has received maintenance dialysis or a kidney transplant.
During the study period, patients receiving maintenance for the treatment of AKI were not on the USRDS registry. A nationally representative cohort of Medicare beneficiaries who did not have ESRD at the time of LVAD placement was identified using the 5% Medicare sample linked to the USRDS registry.
The primary exposure was ESRD versus no ESRD among patients who underwent LVAD placement during the study period. The primary outcome of interest was survival following LVAD placement.
During the study period, 155 Medicare beneficiaries with ESRD and 261 without ESRD in the Medicare 5% sample received an LVAD. Most of the patients with ESRD were on maintenance hemodialysis (79.3%, n=123), 7.7% (n=12) were receiving peritoneal dialysis, and 9.7% (n=15) had a functioning kidney transplant at the time of the LVAD placement.
Of the 155 patients with ESRD, mean age was 58.4 years and 62.0% were male (n=96). Of the cohort without ESRD, mean age was 62.2 years and 75.1% were male (n=196). Compared with the non-ESRD cohort, those with ESRD were more likely to be black (37.4%, n=58 vs 20.3%, n=53) and a greater burden of comorbidity (Quan score, median: 9 vs 6).
For the patients with ESRD, for the years 2003 to 2006, incidence rates of LVAD placement per 10,000 person-years were 0.32; rates for 2006 to 2009 were 0.47 per 10,000 person-years; and for 2010 to 2013, rates were 0.45 per 10,000 person-years. Corresponding rates of LVAD placement among patients without ESRD were 0.06, 0.13, and 0.25, respectively.
During the index hospitalization, receipt of intensive procedures and time spent in the intensive care unit were similar between the two cohorts. More than half (56.1%, n=80) of patients in the ESRD cohort died during the index hospitalization, compared with 4.2% (n=11) of those without ESRD. Of patients who survived the index hospitalization, median length of stay was slightly longer for patients in the ESRD cohort compared with those without ESRD (37 days vs 32 days).
Of patients who survived to hospital discharge, those in the ESRD cohort were less likely to be discharged home compared with patients in the non-ESRD cohort (50% [n=38/76] vs 68/5% [n=172]). Time to readmission was shorter among patients with ESRD compared with those without ESRD (37 days vs 81 days).
Median follow-up was 762 days. By the end of follow-up, 81.9% of LVAD recipients with ESRD had died (n=127), compared with 36.4% (n=95) of those without ESRD. Median time to death for patients with ESRD was 16 days, compared with 2125 days for patients in the non-ESRD cohort. The greatest difference in survival occurred in the first 60 days following placement of an LVAD: 90 patients with ESRD died compared with six without ESRD in that time period (72.4% vs 6.3%, respectively).
The researchers cited several limitations to the study, including relying on diagnostic and procedure codes in administrative data to define and characterize the cohort and the lack of specific data on clinical context in which LVADs were placed, as well as lack of information on the indication for LVAD placement, i.e., as a bridge to transplant or as destination therapy. Finally, the researchers did not conduct separate subgroup analyses due to the small number of patients in the cohort.
In conclusion, the researchers said, “Left ventricular assist device recipients with ESRD at the time of placement have a very poor prognosis, with less than half surviving to hospital discharge and most surviving less than 3 weeks. This information may be crucial in supporting shared decision-making around treatments for advanced heart failure for patients with ESRD.”
- Researchers conducted a study to assess outcomes associated with placement of left ventricular assist devices in patients with and without end-stage renal disease (ESRD)(.
- During median follow-up of 272 days, 81,9% of patients with ESRD died compared with 36.4% of those in the non-ESRD cohort.
- Median time to death among patients with ESRD was 16 days, compared with 2125 days for those without ESRD.