Abstract

Introduction: Management of heart failure (HF) patients incorporates diuretic strategies to reduce congestion and prevent decompensation. Elevated cardiac filling pressures precede signs/symptoms that lead to decompensation; implantable hemodynamic monitoring (IHM) devices allow home monitoring of this signal. The CHAMPION trial found significant reductions in HF hospitalizations (HFH) in NYHA class III HF patients whose syndrome was managed using pulmonary artery pressure (PAP) from an IHM. We examined the potential benefit of PAP monitoring in patients with HF and chronic kidney disease (CKD), a difficult population to manage effectively. Hypothesis: When HF patients with CKD are managed using PAP monitoring, their HFH rates will be significantly reduced when compared to HF patients with CKD managed according to standard of care. Methods: CHAMPION was a prospective, randomized, single-blind study in patients with NYHA class III HF and a recent HF hospitalization. 550 patients were implanted with the IHM device and randomized to HF management with access to PAP (270) or standard of care management (280). Average follow-up was 18 months. CKD was defined as a GFR ! 60 mL/min/1.73m at baseline. Results: 150 treatment group patients and 147 control group patients had CKD at baseline. In controls, patients with CKD had a higher risk for HFH when compared to the overall control population (0.83 vs. 0.68, HR 1.21, p!0.05). When patients with CKD were managed using PAP monitoring, HFH rates were significantly reduced compared to patients with CKD managed according to standard of care (0.48 vs. 0.83, HR 0.58, p!0.001). Benefits of PAP monitoring observed in patients with CKD were consistent with the overall treatment effect (0.48 vs. 0.45, HR 1.05, p50.69). Changes in creatinine and GFR from baseline to 6 months in patients with CKD were similar for patients managed using either PAP monitoring or standard of care. Conclusions: CKD in patients with NYHA class III HF is a risk factor for HFH. Management based upon PAP monitoring significantly reduces HFH in HF patients with CKD and does not adversely affect renal function.

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