a1 Department of Cardiovascular Surgery, Children’s Hospital of Michigan, and Wayne State University School of Medicine, Detroit, Michigan
a2 Quality Improvement for Critical Care Services, Children’s Hospital and Regional Medical Center, Division of Pediatric Critical Care Medicine, University of Washington School of Medicine, Seattle, Washington
a3 Division of Cardiothoracic Surgery, Children’s Hospital and Regional Medical Center, University of Washington School of Medicine, Seattle, Washington
a4 Division of Pediatric Cardiology, Department of Pediatrics, University of California at Los Angeles School of Medicine, Los Angeles, California, United States of America
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.
c1 Correspondence to: Henry L. Walters III, MD, Department of Cardiovascular Surgery, Children’s Hospital of Michigan, 3901 Beaubien Boulevard, Detroit, MI 48201, USA. Tel: 313 745 5538; Fax: 313 993 0531; E-mail: email@example.com