Abstract 10098: Cause, Timing and Location of Death in the Single Ventricle Reconstruction Trial
Objective: The Single Ventricle Reconstruction (SVR) trial randomized 555 subjects with a single right ventricle undergoing the Norwood procedure at 15 North American centers to receive either a modified Blalock-Taussig shunt (MBTS) or right ventricle-to-pulmonary artery shunt (RVPAS). The rate of death or cardiac transplantation by 12 months post-randomization was 36% for the MBTS and 26% for the RVPAS, consistent with other publications. Despite ongoing concerns about the high mortality rate, little is known about the circumstances of these deaths.
Methods: A committee adjudicated all deaths for cause, and recorded the timing, location and other factors for each event.
Results: There were 164 deaths within 12 months post-randomization. The median age at death for these subjects was 1.6 months (interquartile range, 0.6-3.7 months). The highest number of deaths occurred during the Norwood hospitalization (88), followed by the interstage period from Norwood discharge to stage II admission (54). The most common cause of death was cardiovascular (42%), followed by unknown cause (24%) and multi-system organ failure (7%) (Table 1). Cause of death was similar for each shunt. The most common location of death was at an SVR trial hospital (74%), followed by home (13%). In 29/164 subjects (18%), death was categorized as unexpected, with the initial event occurring at home. Twelve of the deaths (41% of unexpected deaths, 7% of all deaths in the SVR trial) were preceded by a prodrome, such as irritability or feeding intolerance.
Conclusions: In infants with a single right ventricle undergoing staged repair, the majority of deaths within the first 12 months are due to cardiovascular causes, occur in hospital and are within the first few months of life. These observational data suggest that improvement in surgical technique, inpatient and outpatient management, and education of family and healthcare providers may improve outcomes for this challenging group of patients.
- © 2011 by American Heart Association, Inc.