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.

Chylothorax and pleural effusion in contemporary extracardiac fenestrated fontan completion

“…The incidence of chylothorax in this series is higher that reported in previous studies, 6,19 including one published by our group. 8 The increasing incidence of chylothorax, from 11.5% to 24%, in the last decade can be explained by the introduction of routine testing for chylomicrons and lymphocyte counts in the early 2000s.…”

Can a Surgeon Refuse to Operate When an Advance Directive Limits Postoperative Care?

“…This is a case of respect for patient autonomy 1 and informed consent 2 , among other principles of medical/surgical therapy. The patient, through the directives of his caregiver, can either have or not have the operation; the surgeon may operate or not operate.…”

“…No one can compel the patient toward an operation that he does not want; no one can order a surgeon to do an operation that he finds confining to his idea of total patient care. The con position of not to take on the operation with the defined stipulations, clearly takes into account respect for patient autonomy and informed consent 1,2 . The patient’s autonomy is respected; the surgeon’s tenets are upheld and preserved.…”

“…Approaching patients with respect for their autonomy is based on a fundamental acknowledgement of their freedom to hold and to act upon judgments that are rooted in one’s personal values and beliefs 1,2 . The principle of respect for patient autonomy follows from one of the main contemporary sources of normative ethical theory: utilitarianism.…”

The science of assessing the outcomes and improving the quality of the congenital and paediatric cardiac care

“…The relationship between volume and outcome has been examined with several analyses that have examined Other recent multiinstitutional studies using STS-CHSD have (1) evaluated failure to rescue (FTR) as a quality metric in paediatric heart surgery [48 & ], (2) examined the effect of sex and race on outcome in patients undergoing congenital heart surgery [52], (3) reviewed perioperative mechanical circulatory support in children [67], (4) provided information about procedure-based complications that can guide informed consent [73], and (5) considered the possibility of geographic variation in congenital heart operations performed in the first year of life [75].…”