title: Congenital cardiac surgical complications of the integument, vascular system, vascular-line(s), and wounds: consensus definitions from the Multi-Societal Database Committee for Pediatric and Congenital Heart Disease.
abstract: A complication is an event or occurrence that is associated with a disease or a healthcare intervention, is a departure from the desired course of events, and may cause, or be associated with, suboptimal outcome. A complication does not necessarily represent a breech in the standard of care that constitutes medical negligence or medical malpractice. An operative or procedural complication is any complication, regardless of cause, occurring (1) within 30 days after surgery or intervention in or out of the hospital, or (2) after 30 days during the same hospitalization subsequent to the operation or intervention. Operative and procedural complications include both intraoperative/intraprocedural complications and postoperative/postprocedural complications in this time interval. The MultiSocietal Database Committee for Pediatric and Congenital Heart Disease has set forth a comprehensive list of complications associated with the treatment of patients with congenital cardiac disease, related to cardiac, pulmonary, renal, haematological, infectious, neurological, gastrointestinal, and endocrinal systems, as well as those related to the management of anaesthesia and perfusion, and the transplantation of thoracic organs. The objective of this manuscript is to examine the definitions of operative morbidity as they relate specifically to a collection of loosely related topics that include the following groups of complications: 1) Complications of the Integument, 2) Complications of the Vascular System, 3) Complications of the Vascular-Line(s), 4) Complications of Wounds. These specific definitions and terms will be used to track morbidity associated with surgical and transcatheter interventions and other forms of therapy in a common language across many separate databases. As surgical survival in children with congenital cardiac disease has improved in recent years, focus has necessarily shifted to reducing the morbidity of congenital cardiac malformations and their treatment. A comprehensive list of complications is presented. This list is a component of a systems-based compendium of complications that will standardize terminology and thereby allow the study and quantification of morbidity in patients with congenital cardiac malformations. Clinicians caring for patients with congenital cardiac disease will be able to use this list for databases, initiatives to improve quality, reporting of complications, and comparing strategies of treatment.
authors.affiliation: Department of Cardiovascular Surgery, Children's Hospital of Michigan, Detroit, Michigan 48201, USA. hwalters@dmc.org
authors.forename: Henry L
authors.initials: HL
authors.lastname: Walters
authors.forename: Howard E
authors.initials: HE
authors.lastname: Jeffries
authors.forename: Gordon A
authors.initials: GA
authors.lastname: Cohen
authors.forename: Thomas
authors.initials: T
authors.lastname: Klitzner
mesh_terms: D006348:Cardiac Surgical Procedures / Q000009:adverse effects*; D002404:Catheterization / Q000009:adverse effects*; D002675:Child, Preschool; D016208:Databases, Factual; D006330:Heart Defects, Congenital / Q000601:surgery*; D006801:Humans; D009017:Morbidity; D011785:Quality Assurance, Health Care / Q000706:statistics & numerical data*; D013530:Surgical Wound Infection / Q000453:epidemiology* / Q000209:etiology; D014481:United States / Q000453:epidemiology; D014652:Vascular Diseases / Q000453:epidemiology* / Q000209:etiology