Outcomes with ambulatory advanced heart failure from the Medical Arm of Mechanically Assisted Circulatory Support (MedaMACS) Registry

Abstract

Background: The outlook for ambulatory patients with advanced heart failure (HF) and the appropriate timing for left ventricular assist device (LVAD) or transplant remain uncertain. The aim of this study was to better understand disease trajectory and rates of progression to subsequent LVAD therapy and transplant in ambulatory advanced HF.

Methods: Patients with advanced HF who were New York Heart Association (NYHA) Class III or IV and Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) Profiles 4 to 7, despite optimal medical therapy (without inotropic therapy), were enrolled across 11 centers and followed for the end-points of survival, transplantation, LVAD placement, and health-related quality of life. A secondary intention-to-treat survival analysis compared outcomes for MedaMACS patients with a matched group of Profile 4 to 7 patients with LVADs from the INTERMACS registry.

Results: Between May 2013 and October 2015, 161 patients were enrolled with INTERMACS Profiles 4 (12%), 5 (32%), 6 (49%), and 7 (7%). By 2 years after enrollment, 75 (47%) patients had reached a primary end-point with 39 (24%) deaths, 17 (11%) undergoing LVAD implantation, and 19 (12%) receiving a transplant. Compared with 1,753 patients with Profiles 4 to 7 receiving LVAD therapy, there was no overall difference in intention-to-treat survival between medical and LVAD therapy, but survival with LVAD therapy was superior to medical therapy among Profile 4 and 5 patients (p = 0.0092). Baseline health-related quality of life was lower among patients receiving a LVAD than those enrolled on continuing oral medical therapy, but increased after 1 year for survivors in both cohorts.

Conclusions: Ambulatory patients with advanced HF are at high risk for poor outcomes, with only 53% alive on medical therapy after 2 years of follow-up. Survival was similar for medical and LVAD therapy in the overall cohort, which included the lower severity Profiles 6 and 7, but survival was better with LVAD therapy among patients in Profiles 4 and 5. Given the poor outcomes in this group of advanced HF patients, timely consideration of transplant and LVAD is of critical importance.

Keywords: advanced heart failure; cardiac transplantation; mechanical circulatory support; patient decision-making; ventricular assist device.

Fig. 1.

MedaMACS Two Year Survival. (A) Kaplan-Meier survival of the entire MedaMACS cohort through 24 months of follow-up. The mortality rate was 17% at 1 year and 24% at 2 years following enrollment. Patients were censored at time of transplant, left ventricular assist device (LVAD) placement, or last follow-up. (B) Kaplan-Meier survival free of LVAD. The rate of death or LVAD placement was 35% 2 years after enrollment. Patients were censored at time of transplant or last follow-up. (C) Kaplan-Meier survival free of LVAD or Transplant. The rate of death, LVAD placement, or transplant was 47% 2 years after enrollment. Patients were censored at time of last follow-up. Shaded areas represent 70% confidence intervals.

Fig. 1.

MedaMACS Two Year Survival. (A) Kaplan-Meier survival of the entire MedaMACS cohort through 24 months of follow-up. The mortality rate was 17% at 1 year and 24% at 2 years following enrollment. Patients were censored at time of transplant, left ventricular assist device (LVAD) placement, or last follow-up. (B) Kaplan-Meier survival free of LVAD. The rate of death or LVAD placement was 35% 2 years after enrollment. Patients were censored at time of transplant or last follow-up. (C) Kaplan-Meier survival free of LVAD or Transplant. The rate of death, LVAD placement, or transplant was 47% 2 years after enrollment. Patients were censored at time of last follow-up. Shaded areas represent 70% confidence intervals.

Fig. 2:

Two Year Survival Stratified by Baseline INTERMACS Patient Profile. (A) Kaplan-Meier survival stratified by baseline Patient Profile was not statistically different. Patients were censored at time of transplant, left ventricular assist device (LVAD) placement, or last follow-up. (B) Kaplan-Meier survival free of LVAD or Transplant stratified by baseline Patient Profile was not statistically different. Patients were censored at time of last follow-up. Patient Profiles 4–5 and 6–7 were combined for analysis. Shaded areas represent 70% confidence intervals.

Fig. 2:

Two Year Survival Stratified by Baseline INTERMACS Patient Profile. (A) Kaplan-Meier survival stratified by baseline Patient Profile was not statistically different. Patients were censored at time of transplant, left ventricular assist device (LVAD) placement, or last follow-up. (B) Kaplan-Meier survival free of LVAD or Transplant stratified by baseline Patient Profile was not statistically different. Patients were censored at time of last follow-up. Patient Profiles 4–5 and 6–7 were combined for analysis. Shaded areas represent 70% confidence intervals.

Fig. 3.

Intention to Treat Two Year Survival with Medical versus LVAD therapy. Kaplan-Meier survival was equivalent with medical therapy (MedaMACS cohort) compared to LVAD therapy (INTERMACS cohort). Medical therapy patients were censored at time of transplant, ventricular assist device placement, or last follow-up. LVAD therapy patients were censored at recovery, transplant, or last follow up. Shaded areas represent 70% confidence intervals.

Fig. 4.

Two Year Survival with Medical versus LVAD therapy stratified by Patient Profile at Enrollment. (A) Kaplan-Meier survival suggested improved actuarial survival with LVAD versus medical therapy among Profile 4–5 patients. (B) Kaplan-Meier survival was equivalent with medical versus LVAD therapy among Profile 6–7 patients. Medical therapy patients were censored at time of transplant, ventricular assist device placement, or last follow-up. LVAD therapy patients were censored at recovery, transplant, or last follow up. Shaded areas represent 70% confidence intervals.

Fig. 5:

Quality of life and survival with medical versus LVAD therapy. (A) Health related quality of life scores as measured by the EuroQol Visual Analog Scale increased with both medical and LVAD therapy. (B) The proportion of patients alive with good quality of life decreased in the medical therapy arm, but increased in the LVAD therapy arm.