Sustained reduction in pulmonary artery pressures and hospitalizations during 2 years of ambulatory monitoring

Background: Therapy guided by pulmonary artery (PA) pressure monitoring reduces PA pressures and heart failure hospitalizations (HFH) during the first year, but durability of efficacy and safety out to two years is not known. Methods and results: The CardioMEMS Post-Approval Study investigated whether benefit and safety were generalized and sustained. Enrollment at 104 US centers included 1200 patients with NYHA Class III symptoms on recommended HF therapies with prior HFH. Therapy was adjusted toward PA diastolic pressure 8-20 mmHg. Intervention frequency and PA pressure reduction were most intense during first 90 days, with sustained reduction of PA diastolic pressure from baseline 24.7 mmHg to 21.0 at 1 year and 20.8 at 2 years, all patients. Patients surviving to 2 years (n=710) showed similar 2-year reduction (23.9 to 20.8 mmHg), with reduction in PA mean pressure (33.7 to 29.4 mmHg) in patients with reduced LVEF. The HFH rate was 1.25 events/patient/year prior to sensor implant, 0.54 at 1 year, and 0.37 at 2 years, with 59% of surviving patients free of HFH. Conclusions: Reduction in PA pressures and hospitalizations were early and sustained during 2 years of PA pressure guided management, with no signal of safety concern regarding the implanted sensor