Risk factors for hospital morbidity and mortality after the Norwood procedure: A report from the Pediatric Heart Network Single Ventricle Reconstruction trial

Abstract

Objectives We sought to identify risk factors for mortality and morbidity during the Norwood hospitalization in newborn infants with hypoplastic left heart syndrome and other single right ventricle anomalies enrolled in the Single Ventricle Reconstruction trial. Methods Potential predictors for outcome included patient- and procedure-related variables and center volume and surgeon volume. Outcome variables occurring during the Norwood procedure and before hospital discharge or stage II procedure included mortality, end-organ complications, length of ventilation, and hospital length of stay. Univariate and multivariable Cox regression analyses were performed with bootstrapping to estimate reliability for mortality. Results Analysis included 549 subjects prospectively enrolled from 15 centers; 30-day and hospital mortality were 11.5% (63/549) and 16.0% (88/549), respectively. Independent risk factors for both 30-day and hospital mortality included lower birth weight, genetic abnormality, extracorporeal membrane oxygenation (ECMO) and open sternum on the day of the Norwood procedure. In addition, longer duration of deep hypothermic circulatory arrest was a risk factor for 30-day mortality. Shunt type at the end of the Norwood procedure was not a significant risk factor for 30-day or hospital mortality. Independent risk factors for postoperative renal failure (n = 46), sepsis (n = 93), increased length of ventilation, and hospital length of stay among survivors included genetic abnormality, lower center/surgeon volume, open sternum, and post-Norwood operations. Conclusions Innate patient factors, ECMO, open sternum, and lower center/surgeon volume are important risk factors for postoperative mortality and/or morbidity during the Norwood hospitalization.

Tracheostomy After Operations for Congenital Heart Disease: An Analysis of the Society of Thoracic Surgeons Congenital Heart Surgery Database

“…In contrast, in the Single Ventricle Reconstruction Trial, a prospective trial of 549 infants undergoing stage I palliation for hypoplastic left heart syndrome, in-hospital mortality was 16%. [14] Follow-up data on the 75% of our study patients who were ultimately discharged to home is not available in the STS-CHSD. Available long-term follow-up data from other studies, however, are not encouraging, especially in regards to patients with hypoplastic left heart syndrome and those requiring long-term ventilation.…”

Neighborhood Socioeconomic Status and Outcomes Following the Norwood Procedure: An Analysis of the Pediatric Heart Network Single Ventricle Reconstruction Trial Public Data Set

“…Therefore, risk factors for adverse outcome in the SV population have been the subject of many investigations. Among these, innate risk factors, such as low birth weight, anatomy, preterm birth, genetic abnormalities, and associated noncardiac congenital anomalies, are well‐established predictors for early mortality and transplantation 3, 4, 5, 6, 7, 8. Recently, societal factors such as poverty, medical insurance, and maternal education have emerged as predictors of adverse outcomes in children with complex congenital heart disease (CHD) and may explain some of the difference in survival between children with similar clinical characteristics 9.…”

“…Specifically, low socioeconomic status (SES) in children with SV physiology has been associated with higher early mortality6, 8 and lower quality of life10 after surgery, and other studies have found similar associations in the larger CHD population 11, 12, 13, 14, 15, 16. Nevertheless, existing studies examining SES have been limited by cross‐sectional or case–control study designs,14, 15 single center populations,7, 9, 10, 14, 15 or limited outcome assessment 6, 8. To date, there has been no in‐depth exploration of the relationship of SES with post‐Norwood outcomes in children with SV physiology.…”

Risk Factors for Death or Heart Transplant for Patients with Right Ventricular Dysfunction After the Norwood Procedure: A Secondary Analysis of the Single Ventricle Reconstruction Trial

“…The Pediatric Heart Network (PHN) investigators also evaluated the risk factors for Norwood hospitalization mortality and thirty-day post-operative mortality (Tabbutt et al 2012 There were 17 (4 %) subjects who died from the stage II procedure to hospital discharge and three subjects (1 %) underwent a heart transplant prior to their hospital discharge (Schwartz et al 2014). Univariate comparison between subjects that died or received a heart transplant to the rest of the cohort revealed that patients who died or received a heart transplant had lower weight for age z score (-2.5 +/-1.6 vs. Anderson & al evaluated the effect of surgeon and institutional volume on post-Norwood hospital mortality using the Pediatric Health Information System database (Anderson et al 2016).…”

“…They also showed no significant differences in RVEF and RVFAC on the pre-stage II echocardiogram and the last follow-up echocardiogram 14 months after randomization. Another secondary analysis of the SVR trial identified that having a BT shunt compare to RVPA conduit was an independent risk factor for ventricular dysfunction on the post-Norwood echocardiogram (Tabbutt et al 2012). Another analysis of the SVR trial demonstrated an increase in late deaths and late heart transplants within the RVPA cohort while evaluating the three-year follow-up, and hypothesized that this was might be related to the longterm effect of the ventriculotomy (Newburger et al 2014).…”