Christian Stoppe1, Bernard McDonald2, Carina Benstoem3, Gunnar Elke4, Patrick Meybohm5, Richard Whitlock6, Stephen Fremes7, Robert Fowler8, Yoan Lamarche9, Xuran Jiang10, Andrew G Day10, Daren K Heyland10. 1. 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. 2. Division of Cardiac Anesthesiology and Critical Care Medicine, University of Ottawa Heart Institute, Ottawa, Ontario, Canada; 3. Department of Thoracic, Cardiac, and Vascular Surgery, University Hospital, RWTH Aachen, Aachen, Germany; 4. Department of Anaesthesiology and Intensive Care Medicine, University Medical Center Schleswig-Holstein, Campus Kiel, Kiel, Germany; 5. Department of Anaesthesiology, Intensive Care Medicine, and Pain Therapy, University Hospital Frankfurt, Frankfurt, Germany; 6. Department of Surgery, Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada; 7. Division of Cardiac Surgery, Schulich Heart Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada; 8. Department of Medicine and Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada; 9. Department of Surgery, Institut de cardiologie de Montreal and Critical Care Program, Hospital du Sacré Coeur de Montréal, Montréal, Quebec, Canada. 10. Clinical Evaluation Research Unit, Angada 4, Kingston General Hospital, Kingston, Ontario, Canada.
Abstract
OBJECTIVES: 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. DESIGN: Secondary analysis extracted from a large-scale prospective randomized trial of critically ill cardiac surgery patients. SETTING: Multi-institutional, university hospitals. PARTICIPANTS: Ninety-five cardiac surgery patients with complicated postoperative courses. INTERVENTIONS:Cardiac surgery with cardiopulmonary bypass. MEASUREMENTS AND MAIN 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.
RCT Entities:
OBJECTIVES: 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. DESIGN: Secondary analysis extracted from a large-scale prospective randomized trial of critically ill cardiac surgery patients. SETTING: Multi-institutional, university hospitals. PARTICIPANTS: Ninety-five cardiac surgery patients with complicated postoperative courses. INTERVENTIONS: Cardiac surgery with cardiopulmonary bypass. MEASUREMENTS AND MAIN 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: Carina Benstoem; Christian Stoppe; Oliver J Liakopoulos; Julia Ney; Dirk Hasenclever; Patrick Meybohm; Andreas Goetzenich Journal: Cochrane Database Syst Rev Date: 2017-05-05
Authors: Michael R Mathis; Neal M Duggal; Allison M Janda; Jordan L Fennema; Bo Yang; Francis D Pagani; Michael D Maile; Ryan E Hofer; Elizabeth S Jewell; Milo C Engoren Journal: J Cardiothorac Vasc Anesth Date: 2021-01-27 Impact factor: 2.894
Authors: Christian Stoppe; Andreas Goetzenich; Glenn Whitman; Rika Ohkuma; Trish Brown; Roupen Hatzakorzian; Arnold Kristof; Patrick Meybohm; Jefferey Mechanick; Adam Evans; Daniel Yeh; Bernard McDonald; Michael Chourdakis; Philip Jones; Richard Barton; Ravi Tripathi; Gunnar Elke; Oliver Liakopoulos; Ravi Agarwala; Vladimir Lomivorotov; Ekaterina Nesterova; Gernot Marx; Carina Benstoem; Margot Lemieux; Daren K Heyland Journal: Crit Care Date: 2017-06-05 Impact factor: 9.097
Authors: Christian Stoppe; Julia Ney; Vladimir V Lomivorotov; Sergey M Efremov; Carina Benstoem; Aileen Hill; Ekaterina Nesterova; Elena Laaf; Andreas Goetzenich; Bernard McDonald; Arne Peine; Gernot Marx; Karl Fehnle; Daren K Heyland Journal: JPEN J Parenter Enteral Nutr Date: 2018-12-02 Impact factor: 4.016
Authors: Aileen Hill; Kai C Clasen; Sebastian Wendt; Ádám G Majoros; Christian Stoppe; Neill K J Adhikari; Daren K Heyland; Carina Benstoem Journal: Nutrients Date: 2019-09-04 Impact factor: 5.717