CardioMEMS Pulmonary Artery Pressure Guided Management of Advanced HF Patients Supported with a HeartMate LVAD: INTELLECT 2-HF Study

Abstract

PurposeHemodynamic-guided management with a pulmonary artery pressure (PAP) sensor (CardioMEMS) is effective in reducing HF hospitalization (HFH) in chronic HF patients. We sought to determine the utility of managing patients on continuous-flow LVAD support using the CardioMEMSTM HF system.MethodsIn this multi-center observational study, we enrolled patients with a HeartMate 2 (HM2) (n=52) or HM3 (n=49) LVAD who either already had a CardioMEMS sensor (n=53) or were clinically implanted after enrollment for residual HF (n=48). Patients underwent assessments at baseline, 1, 3 and 6 months for endpoints: 6-minute walk distance (6MWD), change in PAP, quality of life score (EQ-5D-5L scores), and HFH rates. Patients were stratified post-hoc as clinical responders (cR) if there was a reduction in PA diastolic pressure (PAD) of at least 1 mmHg at 6 months, and the remainder were deemed non-responders (cNR).ResultsOf 101 patients enrolled, 88 patients completed 6-month follow-up. PAP measurement was feasible with excellent weekly patient compliance (91.1% ± 19.8%). There were no clinically relevant differences between cR (n=37) and cNR (n=46) patients at baseline (data not shown). PAD at 6 months was 3.5 ± 4.6 mmHg lower than baseline within the cR group (20.8 to 17.3 mmHg, p=0.0002) (Figure-panel A). While there were no observed differences in QoL or HFH between cR and cNR, significant increases in 6MWD occurred among cR (286 vs 332 meters, p=0.03, Figure-panel B). Those individuals who maintained a PAD < 20mmHg had significantly reduced HFH (Figure-panel C).ConclusionThe use of CardioMEMS system in HeartMate LVAD patients is feasible. Significant reduction in PAD at 6 months was associated with improvements in 6MWD and achieving a PAD < 20 mmHg was associated with lower HFH events. These findings provide justification and guidance for prospective investigations utilizing the CardioMEMS system to improve the management and outcomes of LVAD patients. Hemodynamic-guided management with a pulmonary artery pressure (PAP) sensor (CardioMEMS) is effective in reducing HF hospitalization (HFH) in chronic HF patients. We sought to determine the utility of managing patients on continuous-flow LVAD support using the CardioMEMSTM HF system. In this multi-center observational study, we enrolled patients with a HeartMate 2 (HM2) (n=52) or HM3 (n=49) LVAD who either already had a CardioMEMS sensor (n=53) or were clinically implanted after enrollment for residual HF (n=48). Patients underwent assessments at baseline, 1, 3 and 6 months for endpoints: 6-minute walk distance (6MWD), change in PAP, quality of life score (EQ-5D-5L scores), and HFH rates. Patients were stratified post-hoc as clinical responders (cR) if there was a reduction in PA diastolic pressure (PAD) of at least 1 mmHg at 6 months, and the remainder were deemed non-responders (cNR). Of 101 patients enrolled, 88 patients completed 6-month follow-up. PAP measurement was feasible with excellent weekly patient compliance (91.1% ± 19.8%). There were no clinically relevant differences between cR (n=37) and cNR (n=46) patients at baseline (data not shown). PAD at 6 months was 3.5 ± 4.6 mmHg lower than baseline within the cR group (20.8 to 17.3 mmHg, p=0.0002) (Figure-panel A). While there were no observed differences in QoL or HFH between cR and cNR, significant increases in 6MWD occurred among cR (286 vs 332 meters, p=0.03, Figure-panel B). Those individuals who maintained a PAD < 20mmHg had significantly reduced HFH (Figure-panel C). The use of CardioMEMS system in HeartMate LVAD patients is feasible. Significant reduction in PAD at 6 months was associated with improvements in 6MWD and achieving a PAD < 20 mmHg was associated with lower HFH events. These findings provide justification and guidance for prospective investigations utilizing the CardioMEMS system to improve the management and outcomes of LVAD patients.