High early event rates in patients with questionable eligibility for advanced heart failure therapies: Results from the Medical Arm of Mechanically Assisted Circulatory Support (Medamacs) Registry

Abstract

Background: The prognosis of ambulatory patients with advanced heart failure (HF) who are not yet inotrope dependent and implications for evaluation and timing for transplant or destination therapy with a left ventricular assist device (DT-LVAD) are unknown. We hypothesized that the characteristics defining eligibility for advanced HF therapies would be a primary determinant of outcomes in these patients.

Methods: Ambulatory patients with advanced HF (New York Heart Association class III-IV, Interagency Registry for Mechanically Assisted Circulatory Support profiles 4-7) were enrolled across 11 centers from May 2013 to February 2015. Patients were stratified into 3 groups: likely transplant eligible, DT-LVAD eligible, and ineligible for both transplant and DT-LVAD. Clinical characteristics were collected, and patients were prospectively followed for death, transplant, and left ventricular assist device implantation.

Results: The study enrolled 144 patients with a mean follow-up of 10 ± 6 months. Patients in the ineligible cohort (n = 43) had worse congestion, renal function, and anemia compared with transplant (n = 51) and DT-LVAD (n = 50) eligible patients. Ineligible patients had higher mortality (23.3% vs 8.0% in DT-LVAD group and 5.9% in transplant group, p = 0.02). The differences in mortality were related to lower rates of transplantation (11.8% in transplant group vs 2.0% in DT-LVAD group and 0% in ineligible group, p = 0.02) and left ventricular assist device implantation (15.7% in transplant group vs 2.0% in DT-LVAD group and 0% in ineligible group, p < 0.01).

Conclusions: Ambulatory patients with advanced HF who were deemed ineligible for transplant and DT-LVAD had markers of greater HF severity and a higher rate of mortality compared with patients eligible for transplant or DT-LVAD. The high early event rate in this group emphasizes the need for timely evaluation and decision making regarding lifesaving therapies.

Keywords: cardiac transplantation; destination therapy; mechanical support; patient selection; ventricular assist device.

Figure 1. Medamacs Registry patient inclusion and exclusion criteria

Figure 2

Unadjusted survival among Medamacs Registry patients based on eligibility for Transplant and DT-LVAD. Patients were censored at time of transplant or ventricular assist device placement. Transplant/DT-LVAD Ineligible patients had lower survival compared to the other cohorts. Error bars represent 70% confidence intervals.

Figure 3

Unadjusted survival without transplant or ventricular assist device (VAD) placement among Medamacs Registry patients based on eligibility for Transplant and DT-LVAD. DT-LVAD Eligible patients had the best survival free from transplant or VAD while Transplant Eligible patients had the lowest survival free from transplant or VAD. Error bars represent 70% confidence intervals.