No abstract

Objectives The Single Ventricle Reconstruction 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 or right ventricle-to-pulmonary artery shunt. Results demonstrated a rate of death or cardiac transplantation by 12 months postrandomization of 36% for the modified Blalock-Taussig shunt and 26% for the right ventricle-to-pulmonary artery shunt, consistent with other publications. Despite this high mortality rate, little is known about the circumstances surrounding these deaths. Methods There were 164 deaths within 12 months postrandomization. A committee adjudicated all deaths for cause and recorded the timing, location, and other factors for each event. Results The most common cause of death was cardiovascular (42%), followed by unknown cause (24%) and multisystem organ failure (7%). The median age at death for subjects dying during the 12 months was 1.6 months (interquartile range, 0.6 to 3.7 months), with the highest number of deaths occurring during hospitalization related to the Norwood procedure. The most common location of death was at a Single Ventricle Reconstruction trial hospital (74%), followed by home (13%). There were 29 sudden, unexpected deaths (18%), although in retrospect, 12 were preceded by a prodrome. Conclusions In infants with a single right ventricle undergoing staged repair, the majority of deaths within 12 months of the procedure are due to cardiovascular causes, occur in a hospital, and within the first few months of life. Increased understanding of the circumstances surrounding the deaths of these single ventricle patients may reduce the high mortality rate. (J Thorac Cardiovasc Surg 2012;144:907-14)

Objectives The Single Ventricle Reconstruction trial randomized patients with single right ventricle lesions to a modified Blalock-Taussig or right ventricle-to-pulmonary artery shunt at the Norwood. This analysis describes outcomes at the stage II procedure and factors associated with a longer hospital length of stay (LOS). Methods We examined the association of shunt type with stage II hospital outcomes. Cox regression and bootstrapping were used to evaluate risk factors for longer LOS. We also examined characteristics associated with in-hospital death. Results There were 393 subjects in the analytic cohort. Median stage II procedure hospital LOS (8 days, IQR (6,14)), hospital mortality (4.3%), transplantation (0.8%), median ventilator time (2 days, IQR (1,3)), median intensive care unit LOS (4 days (IQR (3,7)), number of additional cardiac procedures or complications and serious adverse events did not differ by shunt type. Longer LOS was associated (R2=0.26) with center, longer post-Norwood LOS (HR 1.93 per log day, P<0.001), non-elective timing of the stage II procedure (HR 1.78, P<0.001) and pulmonary artery (PA) stenosis (HR 1.56, P<0.001). By univariate analysis, non-elective stage II (65% vs. 32%, P=0.009), ≥ moderate atrioventricular valve (AVV) regurgitation (75% vs. 24%, P<0.001) and AVV repair (53% vs. 9%, P<0.001) were among the risk factors associated with in-hospital death. Conclusions Norwood LOS, PA stenoses and non-elective stage II procedure, but not shunt type, are independently associated with longer LOS. Non-elective stage II, >moderate AVV regurgitation and need for AVV repair are among the risk factors for death.