Informed consent and hypoplastic left heart syndrome.
We present an ethical analysis from the perspective of shared decision-making and informed consent of a change in clinical management of infants born with hypoplastic left heart syndrome (HLHS). We reported a change in treatment of HLHS at the University of Alberta away from comfort care to life-saving surgery (LST) between 1987 and 1998. In a second review (1996-2001), 49/62 infants received LST, with 81% survival from the NICU and 58% at 35 mo. Eleven infants died preoperatively of non-cardiac conditions and two received elective comfort care. Sixteen infants had 18-mo Bayley Mental Development Index, mean score 84+/-19, but five scored <70. Although we continue to present the comfort care option to parents, since 2001 LST use for HLHS at our center is almost universal despite serious complications. We conclude that these findings are inconsistent with an open, shared decision-making model of informed consent and we suggest that comfort care should remain an ethically valid choice until the rate of serious long-term complications of LST decreases.