Hemodynamic-guided heart-failure management using a wireless implantable sensor: Infrastructure, methods, and results in a community heart failure disease-management program

Background: The real-world impact of remote pulmonary artery pressure (PAP) monitoring on New York Heart Association (NYHA) class improvement and heart failure (HF) hospitalization rate is presented here from a single center. Hypothesis: Methods: Seventy-seven previously hospitalized outpatients with NYHA class III HF were offered PAP monitoring via device implantation in a multidisciplinary HF-management program. Prospective effectiveness analyses compared outcomes in 34 hemodynamically monitored patients to a group of similar patients (n = 32) who did not undergo device implantation but received usual care. NYHA class and 6-minute walk testing were assessed at baseline and 90 days. All hospitalizations were collected after 6 months of the implantation date (average follow-up, 15 months) and compared with the number of hospitalizations experienced prior to hemodynamic monitoring. Results: Patients in both groups had similar distributions of age, sex, and ejection fraction. After 90 days, 61.8% of the monitored patients had NYHA class improvement of ≥1, compared with 12.5% in the controls (P < 0.001). Distance walked in 6 minutes increased by 54.5 meters in the monitored group (253.0 ± 25.6 meters to 307.4 ± 26.3 meters; P < 0.005), whereas no change was seen in the usual-care group. After implantation, 19.4% of the monitored group had ≥1 HF hospitalization, compared with 100% who had been hospitalized in the year prior to implantation. The monitored group had a significantly lower HF hospitalization rate (0.16; 95% confidence interval: 0.06-0.35 hospitalizations/patient-year) compared with the year prior (1.0 hospitalizations/patient-year; P < 0.001). Conclusions: Hemodynamic-guided HF management leads to significant improvements in NYHA class and HF hospitalization rate in a real-world setting compared with usual care delivered in a comprehensive disease-management program.