LVAD With Drug Therapy Improved Recovery Following Heart Failure

NEW ORLEANS — Preliminary results from the multicenter RESTAGE (REmission from Stage D Heart Failure) trial demonstrated that intensive drug therapy used in conjunction with a left ventricular assist device (LVAD) helped improve recovery after heart failure.¹

Emma J. Birks, MD, professor of medicine at the University of Louisville in Kentucky and study’s lead author, presented the findings at the 2016 American Heart Association Scientific Sessions in New Orleans.

All patients in the study were scheduled to use an LVAD for the rest of their lives or until transplantation. After roughly 1 year, 13 of 36 patients (36%) had recovered enough heart function to have the LVAD device (HeartMate II; Thoratec Corporation) removed.

This suggests that even very advanced heart failure can be reversed using these heart pumps, particularly when combined with additional drug therapy, avoiding the need for heart transplantation for these patients and making the donor heart available for another needy individual,” Dr Birks said in a press release.

“The fact that this could be done in several centers suggests that using the device with this drug combination to reverse heart failure is possible on a larger scale. It has previously been thought that these devices rarely recover heart function enough to allow them to be removed, but this study suggests that this can occur in a much bigger number than originally thought, particularly if combined with drug therapy.”²

RESTAGE (ClinicalTrials.gov identifier: NCT01774656) is an ongoing trial, including 40 patients treated at 6 centers, aged 18 to 59 years, with advanced heart failure (HF) due to nonischemic cardiomyopathy.

Within the first 209 days, 3 patients died before undergoing therapy and one had the pump removed. The remaining patients received an LVAD and were prescribed a combination of 40 mg Lisinopril, 25 mg spironolactone, 125 mic digoxin, and 150 mg losartan daily, and 25 mg coreg twice a day.

In addition to the 13 patients included in this analysis, 20 patients remain on-study–2 of whom are scheduled to have the LVAD removed. Two other patients have undergone transplantation and 1 died at 763 days post-implantation

Of the 13 patients who’ve already had their LVADs removed, ejection fraction pre-removal was 55% ± 4%, end-diastolic dimension was 46mm ± 6 mm, and end-systolic dimension was 34mm ± 3.2 mm. Pulmonary capillary wedge pressure was 9.2mmHg ± 6.4 mmHg and pulmonary artery saturation was 67% ± 14%.

References

1. Birks EJ, Rame E Patel SR, et al. Poster S4026. REmission from Stage D Heart Failure (RESTAGE-HF): interim results and insights from a prospective multi-center non-randomized study of myocardial recovery using LVADs. Presented at: 2016 American Heart Association Scientific Sessions. November 12-16, 2016; New Orleans, LA.
2. Drug therapy, LVAD helps severe heart failure patients recover function [press release]. Dallas, TX: American Heart Association/American Stroke Association Newsroom; November 13, 2016.