title: 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.
abstract: BACKGROUND
  Serious 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.
  
  
  RESULTS
  151 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).
  
  
  CONCLUSIONS
  NT-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.
authors.affiliation: Division of Cardiology, Massachusetts General Hospital, Boston, Massachusetts.
authors.forename: Parul U
authors.initials: PU
authors.lastname: Gandhi
authors.affiliation: Division of Cardiology, Massachusetts General Hospital, Boston, Massachusetts.
authors.forename: Jackie
authors.initials: J
authors.lastname: Szymonifka
authors.affiliation: Beth Israel Deaconess Medical Center, Boston, Massachusetts.
authors.forename: Shweta R
authors.initials: SR
authors.lastname: Motiwala
authors.affiliation: Division of Cardiology, Massachusetts General Hospital, Boston, Massachusetts.
authors.forename: Arianna M
authors.initials: AM
authors.lastname: Belcher
authors.affiliation: Division of Cardiology, Massachusetts General Hospital, Boston, Massachusetts.
authors.forename: James L
authors.initials: JL
authors.lastname: Januzzi
authors.affiliation: Division of Cardiology, Massachusetts General Hospital, Boston, Massachusetts. Electronic address: hgaggin@mgh.harvard.edu.
authors.forename: Hanna K
authors.initials: HK
authors.lastname: Gaggin
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D015415:Biomarkers / Q000097:blood; D002317:Cardiovascular Agents / Q000009:adverse effects*; D002908:Chronic Disease; D019468:Disease Management; D004244:Dizziness / Q000139:chemically induced / Q000175:diagnosis; D005260:Female; D006333:Heart Failure / Q000097:blood* / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D020097:Natriuretic Peptide, Brain / Q000097:blood*; D010446:Peptide Fragments / Q000097:blood*; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011788:Quality of Life; D051437:Renal Insufficiency / Q000139:chemically induced / Q000175:diagnosis; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D002317:Cardiovascular Agents; D010446:Peptide Fragments; C109794:pro-brain natriuretic peptide (1-76); D020097:Natriuretic Peptide, Brain
keywords: Heart failure; medication; natriuretic peptides