Use of a Pulmonary Artery Pressure Sensor to Manage Patients With Left Ventricular Assist Devices.

Overview

abstract

Background: Hemodynamic-guided management with a pulmonary artery pressure (PAP) sensor (CardioMEMS^TM) is effective in reducing heart failure hospitalization (HFH) in patients with chronic heart failure (HF). This study aims to determine the feasibility and clinical utility of the CardioMEMS HF system to manage patients supported with LVADs. Methods: In this multi-center prospective study, we followed patients with HeartMate II^TM (n=52) or HeartMate 3^TM (n=49) LVADs and with CardioMEMS PA Sensors, and measured PAP, 6-minute walk distance (6MWD), quality of life (EQ-5D-5L scores), and HFH rates through 6 months. Patients were stratified as responders (R) and non-responders (NR) to reductions in PA diastolic pressure (PAD). Results: There were significant reductions in PAD from baseline to 6 months in R (21.5 to 16.5 mmHg, p<0.001), compared to an increase in NR (18.0 to 20.3, p=0.002). and there was a significant increase in 6MWD among R (266 vs 322 meters, p=0.025) compared to no change in NR. Patients who maintained PAD < 20 compared with PAD ≥ 20 mmHg for more than half the time throughout the study (averaging 15.6 vs 23.3 mmHg) had a statistically significant lower rate of HFH (12.0% vs 38.9%, p=0.005). Conclusions: LVAD patients managed with CardioMEMS with a significant reduction in PAD at 6 months showed improvements in 6MWD. Maintaining PAD < 20 mmHg was associated with fewer HF hospitalizations. Hemodynamic-guided management of LVAD patients with CardioMEMS is feasible and may result in functional and clinical benefits. Prospective evaluation of ambulatory hemodynamic management in LVAD patients is warranted. Registration: URL: https://clinicaltrials.gov Unique Identifier: NCT03247829.