title: Procedure-based complications to guide informed consent: analysis of society of thoracic surgeons-congenital heart surgery database.
abstract: BACKGROUND
  Informed consent refers to the process by which physicians and patients engage in a dialogue to explain and comprehend the nature, alternatives, and risks of a procedure or course of therapy. The goal of this study is to better "inform the process of informed consent" by offering empirically derived procedural complication lists that provide objective contemporary data that surgeons may share with patients and families.
  
  
  METHODS
  The Society of Thoracic Surgeons Congenital Heart Surgery Database was queried for complications for 12 congenital heart operations (2010 to 2011) performed across all Society of Thoracic Surgeons-European Association of Cardio-Thoracic Surgery Congenital Heart Surgery (STAT) risk categories.
  
  
  RESULTS
  The 12 index procedures reviewed for rates of complications were repair of atrial septal defect (ASD), ventricular septal defect (VSD), atrioventricular septal defect (AVSD), tetralogy of Fallot (TOF), coarctation, and truncus arteriosus, as well as arterial switch operation (ASO), ASO-VSD, BiGlenn, Fontan, Norwood procedure, and systemic to pulmonary artery (S-P) shunt. Arrhythmia was the most frequent complication for VSD (5.8%), TOF (8.9%), and AVSD (14.7%) repairs. There was a high rate of sternum left open (planned, unplanned) for ASO (26%, 7%), ASO-VSD (29%, 10%), truncus repair (41%, 11%), and Norwood (63%, 7%). The most frequent complications for other procedures include ASD (unplanned readmission, 1.9%), BiGlenn (chylothorax, 7%), Fontan (pleural effusion, 16%), S-P shunt (reintubation, 10.6%), and coarctation (reintubation, 5.2%).
  
  
  CONCLUSIONS
  The informed consent process for congenital heart surgery may be served by accurate contemporary data on occurrence of complications. While a threshold rate of occurrence of individual complications may guide the physician, rare but important debilitating complications should also be discussed irrespective of frequency. We propose to better inform the process of informed consent by providing objective complications data.
authors.affiliation: Johns Hopkins Children's Heart Surgery, Florida Hospital for Children, Orlando, Florida. Electronic address: constantine.mavroudis.md@flhosp.org.
authors.forename: Constantine
authors.initials: C
authors.lastname: Mavroudis
authors.affiliation: Division of Cardiothoracic Surgery, University of Pennsylvania, Philadelphia, Pennsylvania.
authors.forename: Constantine D
authors.initials: CD
authors.lastname: Mavroudis
authors.affiliation: Johns Hopkins Children's Heart Surgery, All Children's Hospital, St. Petersburg, Florida.
authors.forename: Jeffrey P
authors.initials: JP
authors.lastname: Jacobs
authors.affiliation: Johns Hopkins Children's Heart Surgery, Florida Hospital for Children, Orlando, Florida.
authors.forename: Allison
authors.initials: A
authors.lastname: Siegel
authors.affiliation: Department of Pediatrics and Communicable Diseases, University of Michigan, Ann Arbor, Michigan.
authors.forename: Sara K
authors.initials: SK
authors.lastname: Pasquali
authors.affiliation: Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.
authors.forename: Kevin D
authors.initials: KD
authors.lastname: Hill
authors.affiliation: Department of Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland.
authors.forename: Marshall L
authors.initials: ML
authors.lastname: Jacobs
mesh_terms: D019985:Benchmarking; D006348:Cardiac Surgical Procedures / Q000009:adverse effects* / Q000379:methods; D016208:Databases, Factual; D005260:Female; D006330:Heart Defects, Congenital / Q000175:diagnosis* / Q000601:surgery*; D006801:Humans; D007258:Informed Consent; D008297:Male; D011183:Postoperative Complications / Q000453:epidemiology / Q000517:prevention & control*; D012955:Societies, Medical; D013903:Thoracic Surgery