Jeffery P. Jacobs

The complex relationship between pediatric cardiac surgical case volumes and mortality rates in a national clinical database

OBJECTIVE We sought to determine the association between pediatric cardiac surgical volume and mortality using sophisticated case-mix adjustment and a national clinical database. METHODS Patients 18 years of age or less who had a cardiac operation between 2002 and 2006 were identified in the Society of Thoracic Surgeons Congenital Heart Surgery Database (32,413 patients from 48 programs). Programs were grouped by yearly pediatric cardiac surgical volume (small, <150; medium, 150-249; large, 250-349; and very large, >or=350 cases per year). Logistic regression was used to adjust mortality rates for volume, surgical case mix (Aristotle Basic Complexity and Risk Adjustment for Congenital Heart Surgery, Version 1 categories), patient risk factors, and year of operation. RESULTS With adjustment for patient-level risk factors and surgical case mix, there was an inverse relationship between overall surgical volume as a continuous variable and mortality (P = .002). When the data were displayed graphically, there appeared to be an inflection point between 200 and 300 cases per year. When volume was analyzed as a categorical variable, the relationship was most apparent for difficult operations (Aristotle technical difficulty component score, >3.0), for which mortality decreased from 14.8% (60/406) at small programs to 8.4% (157/1858) at very large programs (P = .02). The same was true for the subgroup of patients who underwent Norwood procedures (36.5% [23/63] vs 16.9% [81/479], P < .0001). After risk adjustment, all groups performed similarly for low-difficulty operations. Conversely, for difficult procedures, small programs performed significantly worse. For Norwood procedures, very large programs outperformed all other groups. CONCLUSION There was an inverse association between pediatric cardiac surgical volume and mortality that became increasingly important as case complexity increased. Although volume was not associated with mortality for low-complexity cases, lower-volume programs underperformed larger programs as case complexity increased.

Validation of association of the apolipoprotein E ε2 allele with neurodevelopmental dysfunction after cardiac surgery in neonates and infants.

OBJECTIVE Apolipoprotein E (APOE) genotype is a determinant of neurologic recovery after brain ischemia and traumatic brain injury. The APOE ε2 allele has been associated with worse neurodevelopmental (ND) outcome after repair of congenital heart defects (CHD) in infancy. Replication of this finding in an independent cohort is essential to validate the observed genotype-phenotype association. METHODS The association of APOE genotype with ND outcomes was assessed in a combined cohort of patients with single-ventricle CHD enrolled in the Single Ventricle Reconstruction and Infant Single Ventricle trials. ND outcome was assessed at 14 months using the Psychomotor Development Index (PDI) and Mental Development Index (MDI) of the Bayley Scales of Infant Development-II. Stepwise multivariable regression was performed to develop predictive models for PDI and MDI scores. RESULTS Complete data were available for 298 of 435 patients. After adjustment for preoperative and postoperative covariates, the APOE ε2 allele was associated with a lower PDI score (P = .038). Patients with the ε2 allele had a PDI score approximately 6 points lower than those without the risk allele, explaining 1.04% of overall PDI variance, because the ε2 allele was present in only 11% of the patients. There was a marginal effect of the ε2 allele on MDI scores (P = .058). CONCLUSIONS These data validate the association of the APOE ε2 allele with adverse early ND outcomes after cardiac surgery in infants, independent of patient and operative factors. Genetic variants that decrease neuroresilience and impair neuronal repair after brain injury are important risk factors for ND dysfunction after surgery for CHD.

Heparin-coated cardiopulmonary bypass circuit: clinical effects in pediatric cardiac surgery.

Abstract Objectives: Heparin‐coated cardiopulmonary bypass (CPB) circuits have been reported to reduce complement activation and the inflammatory response associated with CPB. We retrospectively compared patients utilizing heparin‐coated perfusion circuits with those using noncoated circuits to determine the clinical effects of the different circuits in pediatric cardiac surgery. Methods: Between July 1995 and July 1997, 203 patients weighing < 10 kg underwent cardiac surgery, 153 patients using heparin‐coated bypass circuits and 50 patients using noncoated circuits. The 50 patients operated on with the noncoated circuit (Group N) were matched to 100 patients operated on with coated circuits (Group H) in age, weight, and type of procedure. Urine output during bypass, blood products used after bypass, postoperative ventilation days, hospital stay, morbidity, and mortality were compared between these groups. Results: Body weight, perfusion time, and procedure time were not different between the two groups. Urine output during bypass was notably greater in Group H than in Group N (11.3 ± 10.5 mL/kg per hour vs 4.8 ± 3.1 mL/kg per hour, respectively, p < 0.0001). Postoperative mechanical ventilation markedly decreased in Group H (Group H vs N = 2.8 ± 2.7 days vs 5.1 ± 7.5 days, respectively, p < 0.05). Red blood cell usage, hospital stay, morbidity, and mortality were not statistically different, although there was a tendency toward decreased transfusion of red cell and platelets in Group H (Group H vs N = 61.2 ± 121.1 mL/kg vs 102.0 ± 176.7 mL/kg, respectively, in red cell, p = 0.15; and Group H vs N = 7.9 ± 13.7 mL/kg vs 13.2 ± 24.5 mL/kg, respectively, in platelets, p = 0.16). Conclusions: Patients operated on with the use of heparin‐coated circuits had increased urine output during bypass and required less time postoperatively on the ventilator. These results suggest a reduction in the acute inflammatory response, capillary leakage, and overall systemic edema. We now routinely use coated circuits on all pediatric pump cases.

The Society of Thoracic Surgeons voluntary public reporting initiative: the first 4 years.

OBJECTIVES To evaluate participant characteristics and outcomes during the first 4 years of the Society of Thoracic Surgeons (STS) public reporting program. BACKGROUND This is the first detailed analysis of a national, voluntary, cardiac surgery public reporting program using STS clinical registry data and National Quality Forum-endorsed performance measures. METHODS The distributions of risk-adjusted mortality rates, multidimensional composite performance scores, star ratings, and volumes for public reporting versus nonreporting sites were studied during 9 consecutive semiannual reporting periods (2010-2014). RESULTS Among 8929 unique observations (∼1000 STS participant centers, 9 reporting periods), 916 sites (10.3%) were classified low performing, 6801 (76.2%) were average, and 1212 (13.6%) were high performing. STS public reporting participation varied from 22.2% to 46.3% over the 9 reporting periods. Risk-adjusted, patient-level mortality rates for isolated coronary artery bypass grafting were consistently lower in public reporting versus nonreporting sites (P value range: <0.001-0.0077). Reporting centers had higher composite performance scores and star ratings (23.2% high performing and 4.5% low performing vs 7.6% high performing and 13.8% low performing for nonreporting sites). STS public reporting sites had higher mean annualized coronary artery bypass grafting volumes than nonreporting sites (169 vs 145, P < 0.0001); high-performing programs had higher mean coronary artery bypass grafting volumes (n = 241) than average (n = 139) or low-performing (n = 153) sites. Risk factor prevalence (except reoperation) and expected mortality rates were generally stable during the study period. CONCLUSIONS STS programs that voluntarily participate in public reporting have significantly higher volumes and performance. No evidence of risk aversion was found.

Worldwide Trends in Multi-arterial Coronary Artery Bypass Grafting Surgery 2004-2014: A Tale of 2 Continents

Recent evidence shows that multi-arterial coronary artery bypass grafting (MABG) based on bilateral internal thoracic (BITA) or left internal thoracic (LITA) and radial artery (RA) improves long-term outcomes compared with single arterial coronary artery bypass grafting (SABG) (LITA + saphenous vein graft). How this evidence affected the worldwide use of MABG, if at all, is not well defined. Accordingly, we report 10-year temporal trends of MABG utilization from 2 continents. A study population of 1,683,434 non-emergent, primary, isolated LITA-based coronary artery bypass grafting (CABG) (≥2 grafts) patients was derived from the Society of Thoracic Surgeons (STS) (1,307,528 (79.5%) of 1,644,388 isolated CABG; total 1179 centers) and the Australia New Zealand Cardiothoracic (ANZ) Databases (34,213 (87%) of 39,046 isolated CABG; 24 centers) between 2004 and 2014. Patients were excluded based on the following: (1) no LITA, (2) if arterial grafts were other than RA or ITA, or (3) if grafting data were missing. The 3 MABG groups were LITA + RA, BITA, and BITA + RA, each with or without supplemental vein grafts. Grafting trends and their associated patient demographics were analyzed. SABG (89.3% STS, 51.4% ANZ) was the most common grafting strategy. MABG was most frequently accomplished by LITA + RA: (STS: 6.1%; ANZ: 42.6%), followed by BITA: (STS: 4.1%; ANZ: 4.3%), while ≥3 (BITA + RA) was rare in the STS (0.5%), but more common in ANZ (5.9%). In the STS, between 2004 and 2014, SABG rates systematically increased from 85.2% to 91.7%, BITA grafting was essentially unchanged from 3.6% to 4.3%, while RA use decreased systematically from 10.5% to 3.7%. In the ANZ, SABG rates increased from 17.3% to 51.4%, BITA grafting decreased from 6.3% to 3.6%, while RA grafting decreased from 65.8% to 39.0%. Compared with SABG patients, BITA patients were younger (STS: median age 59 vs 66, P < 0.001; ANZ: mean age 62 vs 68, P < 0.001), predominately male (STS: 84% vs 73%, P < 0.001; ANZ: 86% vs 79%, P < 0.001), less obese (body mass index >30 kg/m2) in STS (37% vs 42%, P < 0.001), more obese in ANZ (33% vs 32%, P = 0.001), and less diabetic (STS: 26% vs 43%, P < 0.001; ANZ: 25% vs 37%, P < 0.001), whereas RA patients were intermediate in age (STS: 61; ANZ: 65), in male sex (STS: 82%; ANZ: 81%), in the prevalence of diabetes (STS: 40%; ANZ: 34%), and were most obese (STS: 47%; ANZ: 34%). A decade-long analysis of STS data reveals a counterintuitive decline in the use (driven by decreasing RA use) of MABG: a potentially superior grafting strategy compared with SABG. In contra distinction, the smaller but growing ANZ data document a distinctly different CABG practice pattern, with a higher MABG utilization rate, but a similarly declining RA use. The reasons for these practice patterns and declining MABG are likely diverse and require further assessment.

Association of Hospital and Physician Characteristics and Care Processes with Racial Disparities in Procedural Outcomes Among Contemporary Patients Undergoing Coronary Artery Bypass Grafting Surgery

Background— Previous studies have reported that black patients undergoing coronary artery bypass surgery had worse outcomes than white patients, even after accounting for patient factors. The degree to which clinician, hospital, and care factors account for these outcome differences remains unclear. Methods and Results— We evaluated procedural outcomes in 11 697 blacks and 136 362 whites undergoing isolated coronary artery bypass surgery at 663 Society of Thoracic Surgery Database participating sites (January 1, 2010 to June 30, 2011) adjusted for patients’ clinical and socioeconomic features, hospital and surgeon effects, and care processes (internal mammary artery graft and perioperative medications use). Relative to whites, blacks undergoing coronary artery bypass surgery were younger, yet had higher comorbidities and more adverse presenting features. Blacks were also more likely to be treated at hospitals with higher risk-adjusted mortality. The use of internal mammary artery was marginally lower in blacks than in whites (93.3% versus 92.2%, P<0.0001). Unadjusted mortality and major morbidity rates were higher in blacks than in whites (1.8% versus 2.5%, P<0.0001) and (13.6% versus 19.4%, P<0.0001), respectively. These racial differences in outcomes narrowed but still persisted after adjusting for surgeon, hospital, and care processes in addition to patient and socioeconomic factors (odds ratio, 1.17; 95% confidence interval, 1.00–1.36 and odds ratio, 1.26; 95% confidence interval, 1.19–1.34, respectively). Conclusions— The risks of procedural mortality and morbidity after coronary artery bypass surgery were higher among black patients than among white patients. These differences were in part accounted for by patient comorbidities, socioeconomic status, and surgeon, hospital, and care factors, as well, as suggested by the reduction in the strength of the race-outcomes association. However, black race remained an independent predictor of outcomes even after accounting for these differences.

Ex vivo paracrine properties of cardiac tissue: Effects of chronic heart failure

BACKGROUND Cardiac regenerative responses are responsive to paracrine factors. We hypothesize that chronic heart failure (HF) in pediatric patients affects cardiac paracrine signaling relevant to resident c-kit(+)cluster of differentiation (CD)34- cardiac stem cells (CSCs). METHODS Discarded atrial septum (huAS) and atrial appendages (huAA) from pediatric patients with HF (huAA-HF; n = 10) or without HF (n = 3) were explanted and suspension explant cultured in media. Conditioned media were screened for 120 human factors using unedited monoclonal antibody-based arrays. Significantly expressed (relative chemiluminescence >30 of 100) factors are reported (secretome). Emigrated cells were immunoselected for c-kit and enumerated as CSCs. RESULTS After culture Day 7, CSCs emigrate from huAA but not huAS. The huAA secretome during CSC emigration included hepatocyte growth factor (HGF), epithelial cell-derived neutrophil attractant-78 (ENA-78)/chemokine (C-X-C motif) ligand (CXCL) 5, growth-regulated oncogene-α (GRO-α)/CXCL1, and macrophage migration inhibitory factor (MIF), candidate pro-migratory factors not present in the huAS secretome. Survival/proliferation of emigrated CSCs required coculture with cardiac tissue or tissue-conditioned media. Removal of huAA (Day 14) resulted in the loss of all emigrated CSCs (Day 28) and in decreased expression of 13 factors, including HGF, ENA-78/CXCL5, urokinase-type plasminogen activator receptor (uPAR)/CD87, and neutrophil-activating protein-2 (NAP-2)/CXCL7 candidate pro-survival factors. Secretomes of atrial appendages from HF patients have lower expression of 14 factors, including HGF, ENA-78/CXCL5, GRO-α/CXCL1, MIF, NAP-2/CXCL7, uPAR/CD87, and macrophage inflammatory protein-1α compared with AA from patients without HF. CONCLUSIONS Suspension explant culturing models paracrine and innate CSC interactions in the heart. In pediatric patients, heart failure has an enduring effect on the ex vivo cardiac-derived secretome, with lower expression of candidate pro-migratory and pro-survival factors for CSCs.

International quality improvement initiatives

Across the globe, the implementation of quality improvement science and collaborative learning has positively affected the care and outcomes for children born with CHD. These efforts have advanced the collective expertise and performance of inter-professional healthcare teams. In this review, we highlight selected quality improvement initiatives and strategies impacting the field of cardiovascular care and describe implications for future practice and research. The continued leveraging of technology, commitment to data transparency, focus on team-based practice, and recognition of cultural norms and preferences ensure the success of sustainable models of global collaboration.

Can Randomized Clinical Trials Impact the Surgical Approach for Hypoplastic Left Heart Syndrome

The Eighth International Conference of the Pediatric Cardiac Intensive Care Society was held in Miami, Florida, December 8 to 11, 2010. The program included a session dedicated to the management of hypoplastic left heart syndrome (HLHS), with particular emphasis on the innovations that have led to contemporary schemes of management and the role of clinical trials in the evolution and acceptance of these strategies. An invited panel of experts reviewed the historical evolution of staged surgical reconstruction, the randomized clinical trials that have been undertaken thus far, and the extent to which these have, or have not, influenced individual and institutional approaches to management of HLHS.

The World Database for Pediatric and Congenital Heart Surgery: Use of an International Congenital Database in South Korea

© The Korean Society for Thoracic and Cardiovascular Surgery. 2018. All right reserved. This is an open access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/ licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. Table 1. Congenital cardiac programs in South Korea