title: Evaluation of Persistent Organ Dysfunction Plus Death As a Novel Composite Outcome in Cardiac Surgical Patients.
abstract: OBJECTIVE
  Validated composite outcomes after complicated cardiac surgery are poorly established. Therefore, the authors evaluated a novel composite endpoint, persistent organ dysfunction (POD)+death, which is defined as any need for life-sustaining therapies or death at any time within 28 days from surgery.
  
  
  METHODS
  Secondary analysis extracted from a large-scale prospective randomized trial of critically ill cardiac surgery patients.
  
  
  METHODS
  Multi-institutional, university hospitals.
  
  
  METHODS
  Ninety-five cardiac surgery patients with complicated postoperative courses.
  
  
  METHODS
  Cardiac surgery with cardiopulmonary bypass.
  
  
  RESULTS
  At 28 days following surgery, the prevalence of POD was 15%, and 23% of patients had died (POD+death = 38%). Patients alive with POD at day 28 exhibited a significantly higher extent of organ injury and longer ICU (33 v 7 days; p<0.001) and hospital lengths of stay (49 v 21 days; p<0.001) compared to patients without POD at day 28. At 3 and 6 months, quality-of-life scores (by Short Form 36 questionnaire) showed a significantly reduced rating for most components in patients with POD at day 28 compared to those without POD. The 6-month mortality rate was 21% among patients alive with POD at day 28 compared to 5% among patients alive without POD (p = 0.05). The calculated number of patients needed per arm to detect a 25% relative risk reduction for mortality alone was 762 compared to 386 per arm for POD+ death.
  
  
  CONCLUSIONS
  POD+death at day 28 following cardiac surgery may be a valid composite endpoint and offers statistical efficiencies in terms of sample size calculations for cardiac surgical trials.
authors: Department of Anesthesiology, University Hospital RWTH Aachen, Aachen, Germany;; Department of Thoracic, Cardiac, and Vascular Surgery, University Hospital, RWTH Aachen, Aachen, Germany;. Electronic address: christian.stoppe@gmail.com.
authors: Christian
authors: C
authors: Stoppe
authors: Division of Cardiac Anesthesiology and Critical Care Medicine, University of Ottawa Heart Institute, Ottawa, Ontario, Canada;
authors: Bernard
authors: B
authors: McDonald
authors: Department of Thoracic, Cardiac, and Vascular Surgery, University Hospital, RWTH Aachen, Aachen, Germany;
authors: Carina
authors: C
authors: Benstoem
authors: Department of Anaesthesiology and Intensive Care Medicine, University Medical Center Schleswig-Holstein, Campus Kiel, Kiel, Germany;
authors: Gunnar
authors: G
authors: Elke
authors: Department of Anaesthesiology, Intensive Care Medicine, and Pain Therapy, University Hospital Frankfurt, Frankfurt, Germany;
authors: Patrick
authors: P
authors: Meybohm
authors: Department of Surgery, Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada;
authors: Richard
authors: R
authors: Whitlock
authors: Division of Cardiac Surgery, Schulich Heart Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada;
authors: Stephen
authors: S
authors: Fremes
authors: Department of Medicine and Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada;
authors: Robert
authors: R
authors: Fowler
authors: Department of Surgery, Institut de cardiologie de Montreal and Critical Care Program, Hospital du Sacré Coeur de Montréal, Montréal, Quebec, Canada.
authors: Yoan
authors: Y
authors: Lamarche
authors: Clinical Evaluation Research Unit, Angada 4, Kingston General Hospital, Kingston, Ontario, Canada.
authors: Xuran
authors: X
authors: Jiang
authors: Clinical Evaluation Research Unit, Angada 4, Kingston General Hospital, Kingston, Ontario, Canada.
authors: Andrew G
authors: AG
authors: Day
authors: Clinical Evaluation Research Unit, Angada 4, Kingston General Hospital, Kingston, Ontario, Canada.
authors: Daren K
authors: DK
authors: Heyland
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D006348:Cardiac Surgical Procedures / Q000009:adverse effects* / Q000401:mortality*; D005260:Female; D017052:Hospital Mortality / Q000639:trends; D006801:Humans; D008297:Male; D008875:Middle Aged; D009102:Multiple Organ Failure / Q000175:diagnosis / Q000401:mortality*; D011183:Postoperative Complications / Q000175:diagnosis / Q000401:mortality*; D011446:Prospective Studies; D012189:Retrospective Studies; D016896:Treatment Outcome
keywords: cardiac surgery; composite outcome measurements; organ dysfunctions