Characterization and Prediction of Adverse Events From Intensive Chronic Heart Failure Management and Effect on Quality of Life: Results From the Pro-B-Type Natriuretic Peptide Outpatient-Tailored Chronic Heart Failure Therapy (PROTECT) Study

• Biomarker-guided care is safe in patients with heart failure and reduced ejection fraction.
• Patients who experienced serious adverse events (SAEs) were less likely to be taking β-blockers.
• Patients with SAEs had less improvement in quality of life and left ventricular remodeling.
• A risk score to predict the occurrence of SAEs was developed.

BackgroundSerious adverse events (SAEs) from heart failure (HF) therapy are frequent; however, techniques to identify at-risk patients are inadequate. Furthermore, the relationship between SAEs, quality of life (QOL), and cardiac structure are unknown.Methods and Results151 symptomatic patients with systolic HF were followed for a mean of 10 months. In this post hoc analysis, treatment-related SAEs included acute renal failure, dizziness, hypo/hyperkalemia, hypotension, and syncope. At 1 year, 21 treatment-related SAEs occurred. No difference in SAEs existed between the N-terminal pro-B-type natriuretic peptide (NT-proBNP)–guided arm and the standard of care arm (P = .20). At baseline, patients who suffered SAEs were less likely to be receiving beta-blockers (85.7% vs 97.7%; P = .009) and had worse functional class and lower chloride levels. Patients who experienced SAEs had less improvement in their Minnesota Living With Heart Failure Questionnaire scores and had a trend toward reduced echocardiographic reverse remodeling over the follow-up period. Univariable and multivariable analyses were conducted to develop a risk score for SAE prediction; patients in the highest risk quartile had the shortest time to first cardiovascular event (P = 0.01).ConclusionsNT-proBNP–guided HF care is safe. Experiencing treatment-related SAEs is associated with worse QOL and potentially reduced reverse remodeling. A risk score to prospectively predict SAEs in aggressive HF management was developed.