Due to safety concerns associated with some mask-based therapies for patients with heart failure and reduced left ventricular ejection fraction (LVEF), post-hoc analysis was performed on the heart failure cohort from the Pivotal Trial.
Patients with both heart failure and central sleep apnea comprise over half (68%) of patients studied in the remedē® System Pilot and Pivotal studies. In post-hoc analysis, the heart failure cohort demonstrated similar sleep and quality of life improvements to that of the full population.1,2
1. Costanzo MR, et al. European Journal of Heart Failure 2018; doi:10.1002/ejhf.1312.
2. Fudim M, Spector AR, Costanzo MR, et al. J Clin Sleep Med. 2019;15(12):17471755.
3. Ponikowski P, et al. Eur J Heart Fail 2019;21 (S1): 346; doi:10.1002/ejhf.1488