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1.  Quality Measures for Congenital and Pediatric Cardiac Surgery 
World journal for pediatric & congenital heart surgery  2012;3(1):10.1177/2150135111426732.
This article presents 21 “Quality Measures for Congenital and Pediatric Cardiac Surgery” that were developed and approved by the Society of Thoracic Surgeons (STS) and endorsed by the Congenital Heart Surgeons’ Society (CHSS). These Quality Measures are organized according to Donabedian’s Triad of Structure, Process, and Outcome. It is hoped that these quality measures can aid in congenital and pediatric cardiac surgical quality assessment and quality improvement initiatives.
PMCID: PMC3827684  PMID: 23804682
database; outcomes; quality assessment; quality improvement
2.  An empirically based tool for analyzing morbidity associated with operations for congenital heart disease 
The Journal of thoracic and cardiovascular surgery  2012;145(4):10.1016/j.jtcvs.2012.06.029.
Congenital heart surgery outcomes analysis requires reliable methods of estimating the risk of adverse outcomes. Contemporary methods focus primarily on mortality or rely on expert opinion to estimate morbidity associated with different procedures. We created an objective, empirically based index that reflects statistically estimated risk of morbidity by procedure.
Morbidity risk was estimated using data from 62,851 operations in the Society of Thoracic Surgeons Congenital Heart Surgery Database (2002-2008). Model-based estimates with 95% Bayesian credible intervals were calculated for each procedure’s average risk of major complications and average postoperative length of stay. These 2 measures were combined into a composite morbidity score. A total of 140 procedures were assigned scores ranging from 0.1 to 5.0 and sorted into 5 relatively homogeneous categories.
Model-estimated risk of major complications ranged from 1.0% for simple procedures to 38.2% for truncus arteriosus with interrupted aortic arch repair. Procedure-specific estimates of average postoperative length of stay ranged from 2.9 days for simple procedures to 42.6 days for a combined atrial switch and Rastelli operation. Spearman rank correlation between raw rates of major complication and average postoperative length of stay was 0.82 in procedures with n greater than 200. Rate of major complications ranged from 3.2% in category 1 to 30.0% in category 5. Aggregate average postoperative length of stay ranged from 6.3 days in category 1 to 34.0 days in category 5.
Complication rates and postoperative length of stay provide related but not redundant information about morbidity. The Morbidity Scores and Categories provide an objective assessment of risk associated with operations for congenital heart disease, which should facilitate comparison of outcomes across cohorts with differing case mixes.
PMCID: PMC3824389  PMID: 22835225
3.  Moderate altitude is not associated with adverse postoperative outcomes for patients undergoing bidirectional cavopulmonary anastomosis and Fontan operation: A comparative study among Denver, Edmonton, and Toronto 
Outcomes of patients with single ventricle physiology undergoing cavopulmonary palliations depend on pulmonary vascular resistance (PVR) and have been suggested to be adversely affected by living at elevated altitude. We compared the pulmonary hemodynamic data in correlation with postoperative outcomes at the 3 centers of Denver, Edmonton, and Toronto at altitudes of 1604, 668, and 103 meters, respectively.
Hemodynamic data at pre-bidirectional cavopulmonary anastomosis (BCPA) and pre-Fontan catheterization between 1995 and 2007 were collected. Death from cardiac failure or heart transplantation in the same period was used to define palliation failure.
There was no significant correlation between altitude (ranged from 1 to 2572 meters) and PVR, pulmonary artery pressure (PAP) or transpulmonary gradient (TPG) at pre-BCPA and pre-Fontan catheterization. BCPA failure occurred in 11 (9.2%) patients in Denver, 3 (2.9%) in Edmonton, and 34 (11.9%) in Toronto. Fontan failure occurred in 3 (6.1%) patients in Denver, 5 (7.2%) in Edmonton, and 11 (7.0%) in Toronto. There was no significant difference in BCPA and Fontan failure among the 3 centers. BCPA failure positively correlated with PVR and the presence of a right ventricle as the systemic ventricle. Fontan failure positively correlated with PAP and TPG.
Moderate altitude is not associated with an increased PVR or adverse outcomes in patients with a functional single ventricle undergoing BCPA and the Fontan operation. The risk factors for palliation failure are higher PVR, PAP, and TPG and a systemic right ventricle, but not altitude. Our study reemphasizes the importance of cardiac catheterization assessments of pulmonary hemodynamics before BCPA and Fontan operations.
PMCID: PMC3800264  PMID: 23353110
4.  Initial application in the EACTS and STS Congenital Heart Surgery Databases of an empirically derived methodology of complexity adjustment to evaluate surgical case mix and results† 
Outcomes evaluation is enhanced by assignment of operative procedures to appropriate categories based upon relative average risk. Formal risk modelling is challenging when a large number of operation types exist, including relatively rare procedures. Complexity stratification provides an alternative methodology. We report the initial application in the Congenital Heart Surgery Databases of the Society of Thoracic Surgeons (STS) and the European Association for Cardio-thoracic Surgery (EACTS) of an empirically derived system of complexity adjustment to evaluate surgical case mix and results.
Complexity stratification is a method of analysis in which the data are divided into relatively homogeneous groups (called strata). A complexity stratification tool named the STS–EACTS Congenital Heart Surgery Mortality Categories (STAT Mortality Categories) was previously developed based on the analysis of 77 294 operations entered in the Congenital Heart Surgery Databases of EACTS (33 360 operations) and STS (43 934 patients). Procedure-specific mortality rate estimates were calculated using a Bayesian model that adjusted for small denominators. Operations were sorted by increasing risk and grouped into five categories (the STAT Mortality Categories) that were designed to minimize within-category variation and maximize between-category variation. We report here the initial application of this methodology in the EACTS Congenital Heart Surgery Database (47 187 operations performed over 4 years: 2006–09) and the STS Congenital Heart Surgery Database (64 307 operations performed over 4 years: 2006–09).
In the STS Congenital Heart Surgery Database, operations classified as STAT Mortality Categories 1–5 were (1): 17332, (2): 20114, (3): 9494, (4): 14525 and (5): 2842. Discharge mortality was (1): 0.54%, (2): 1.6%, (3): 2.4%, (4): 7.5% and (5): 17.8%. In the EACTS Congenital Heart Surgery Database, operations classified as STAT Mortality Categories 1–5 were (1): 19874, (2): 12196, (3): 5614, (4): 8287 and (5): 1216. Discharge mortality was (1): 0.99%, (2): 2.9%, (3): 5.0%, (4): 10.3% and (5): 25.0%.
The STAT Mortality Categories facilitate analysis of outcomes across the wide spectrum of distinct congenital heart surgery operations including infrequently performed procedures.
PMCID: PMC3858079  PMID: 22700597
Database; Outcomes; Quality assessment; Quality improvement
5.  The Importance of Nomenclature for Congenital Heart Disease: Implications for Research and Evaluation 
Cardiology in the young  2008;18(0 2):92-100.
Administrative databases are often used for congenital heart disease research and evaluation, with little validation of the accuracy of the diagnostic codes.
Metropolitan Atlanta Congenital Defects Program surveillance records were reviewed and classified using a version of the International Pediatric and Congenital Cardiac Code. Using this clinical nomenclature as the referent, we report the sensitivity and false positive fraction (1 – positive predictive value) of the International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis codes for tetralogy of Fallot, transposition of the great arteries, and hypoplastic left heart syndrome.
We identified 4918 infants and foetuses with congenital heart disease from the surveillance records. Using only the International Classification of Diseases diagnosis codes, there were 280 records with tetralogy, 317 records with transposition, and 192 records with hypoplastic left heart syndrome. Based on the International Pediatric and Congenital Cardiac Code, 330 records were classified as tetralogy, 163 records as transposition, and 179 records as hypoplastic left heart syndrome. The sensitivity of International Classification of Diseases diagnosis codes was 83% for tetralogy, 100% for transposition, and 95% for hypoplastic left heart syndrome. The false positive fraction was 2% for tetralogy, 49% for transposition, and 11% for hypoplastic left heart syndrome.
Analyses based on International Classification of Diseases diagnosis codes may have substantial misclassification of congenital heart disease. Isolating the major defect is difficult, and certain codes do not differentiate between variants that are clinically and developmentally different.
PMCID: PMC3743224  PMID: 19063779
congenital heart disease; nomenclature; surveillance
6.  Heterotaxy: Lessons Learned about Patterns of Practice and Outcomes from the Congenital Heart Surgery Database of the Society of Thoracic Surgeons 
“Heterotaxy is synonymous with `visceral heterotaxy' and `heterotaxy syndrome'. Heterotaxy is defined as an abnormality where the internal thoraco-abdominal organs demonstrate abnormal arrangement across the left-right axis of the body. By convention, heterotaxy does not include patients with either the expected usual or normal arrangement of the internal organs along the left-right axis, also known as `situs solitus', nor patients with complete mirror-imaged arrangement of the internal organs along the left-right axis also known as `situs inversus'.” The purpose of this manuscript is to review the data about heterotaxy in the STS Congenital Heart Surgery Database.
We examined all index operations in the STS Congenital Heart Surgery Database over 12 years from January 1, 1998 - December 31, 2009, inclusive. This analysis resulted in a cohort of 77,153 total index operations. Of these 77,153 index operations, 1,505 (1.95%) were performed in patients with heterotaxy. Of the 1,505 index operations performed in patients with heterotaxy, 1,144 were in patients with “asplenia” and 361 were in patients with” polysplenia”.
In every STS–EACTS Congenital Heart Surgery Mortality Category (2009) (STS–EACTS Category), discharge mortality is higher in patients with heterotaxy compared to patients without heterotaxy. Discharge mortality after Systemic to pulmonary artery shunt is 6.6% in a cohort of all Single Ventricle patients except those with heterotaxy, while it is 10.8% in Single Ventricle patients with heterotaxy. Discharge mortality after Fontan is 1.8% in a cohort of all Single Ventricle patients except those with heterotaxy, while it is 4.2% in Single Ventricle patients with heterotaxy.
The STS Database is largest Congenital Heart Surgery Database in North America. This review of data from the STS Congenital Heart Surgery Database allows for unique documentation of practice patterns and outcomes. From this analysis, it is clear that heterotaxy is a challenging problem with increased discharge mortality in most subgroups.
PMCID: PMC3695419  PMID: 23804985
heterotaxy syndrome; isomerism; asplenia; polysplenia; database; congenital heart disease; outcomes; cardiac surgery; results of treatment
7.  Richard E. Clark Paper: Variation in Outcomes for Benchmark Operations: An analysis of the STS Congenital Heart Surgery Database 
The Annals of Thoracic Surgery  2011;92(6):2184-2192.
We evaluated outcomes for common operations in the STS Congenital Heart Surgery Database (STS-CHSDB) to provide contemporary benchmarks and examine variation between centers.
Patients undergoing surgery from 2005-2009 were included. Centers with>10% missing data were excluded. Discharge mortality and postoperative length of stay (PLOS) among patients discharged alive were calculated for eight benchmark operations of varying complexity. Power for analyzing between-center variation in outcome was determined for each operation. Variation was evaluated using funnel plots and Bayesian hierarchical modeling.
18,375 index operations at 74 centers were included in the analysis of eight benchmark operations. Overall discharge mortality (range) was: ventricular septal defect repair (VSD) 0.6% (0%–5.1%), tetralogy of Fallot repair (TOF) 1.1% (0%–16.7%), complete atrioventricular canal repair (AVC) 2.2% (0%–20%), arterial switch (ASO) 2.9% (0%–50%), ASO+VSD 7.0% (0%–100%), Fontan 1.3% (0%–9.1%), truncus repair 10.9% (0%–100%), Norwood 19.3% (2.9%–100%). Funnel plots revealed the number of centers characterized as outliers were: VSD=0, TOF=0, AVC=1, ASO=3, ASO+VSD=1, Fontan=0, Truncus=4, Norwood=11. Power calculations showed statistically meaningful comparisons of mortality rates between centers could only be made for Norwood, for which the Bayesian-estimated range (95% Probability Interval) was 7.0% (3.7%-10.3%) to 41.6% (30.6%-57.2%). Between-center variation in PLOS was analyzed for all operations and was larger for more complex operations.
This analysis documents contemporary benchmarks for common pediatric cardiac surgical operations and the range of outcomes among centers. Variation was most prominent for the more complex operations. These data may aid in quality assessment and quality improvement initiatives.
PMCID: PMC3263755  PMID: 22115229
database; outcomes
8.  Morbidity of the Arterial Switch Operation 
The Annals of Thoracic Surgery  2012;93(6):1977-1983.
The arterial switch operation (ASO) has become a safe, reproducible surgical procedure with low mortality in experienced centers. We examined morbidity, which remains significant, particularly for complex ASO.
From 2003 to 2011, 101 consecutive patients underwent ASO, arbitrarily classified as “simple” (n = 52) or “complex” (n = 49). Morbidity was measured in selected complications and postoperative hospitalization. Three outcomes were analyzed: ventilation time, postextubation hospital length of stay, and a composite morbidity index, defined as ventilation time + postextubation hospital length of stay + occurrence of selected major complications. Complexity was measured with the comprehensive Aristotle score.
The operative mortality was zero. Twenty-five major complications occurred in 23 patients: 6 of 25 (12%) in simple ASO and 19 of 49 (39%) in complex ASO (p = 0.002). The most frequent complication was unplanned reoperation (15 vs 6, p = 0.03). No patients required permanent pacing. The complex group had a significantly higher morbidity index and longer ventilation time and postextubation hospital length of stay. In multivariate analysis, factors independently predicting higher morbidity were the comprehensive Aristotle score, arch repair, bypass time, and malaligned commissures. Myocardial infarction caused one sudden late death at 3 months. Late coronary failure was 2%. Overall survival was 99% at a mean follow-up of 49 ± 27 months.
In this consecutive series without operative mortality, morbidity was significantly higher in complex ASO. The only anatomic incremental risk factors for morbidity were aortic arch repair and malaligned commissures, but not primary diagnosis, weight less than 2.5 kg, or coronary patterns.
PMCID: PMC3381339  PMID: 22365263
9.  Performance of Cavopulmonary Palliation at Elevated Altitude 
Circulation  2008;118(14 Suppl):S177-S181.
Outcomes of patients undergoing cavopulmonary palliation for single ventricle physiology may be impacted by living at altitude, as the passive pulmonary circulation is dependent on the resistance of the pulmonary vascular bed. The objective of this study is to identify risk factors for failure of cavopulmonary palliation at elevated altitude.
Methods and Results
Between January 1995 and March 2007, 122 consecutive patients living at a mean altitude of 1600 m (range 305 to 2570) underwent a bidirectional Glenn (BDG). There was one in-hospital mortality and 7 late deaths. 52 have proceeded to the Fontan procedure. Survival after BDG was 92.4% at 5 years. Freedom from palliation failure, defined as death, transplant, BDG/Fontan takedown, or revision was 81% at 5 years. At a mean follow-up of 39.8 months, 90 patients (75%) were in New York Heart Association class I. Patients with failing cavopulmonary circulation had higher pre-BDG pulmonary artery pressure (PAP) (18.3±6.1 mm Hg versus 14.8±5.1 mm Hg, P=0.016) and higher pre-BDG transpulmonary gradient (TPG) (11.2±6.2 mm Hg versus 7.7±4.3 mm Hg, P=0.014). Post-BDG, patients with palliation failure had increased PAP (15.0±5.7 mm Hg versus 10.8±2.8 mm Hg, P=0.008) and indexed pulmonary vascular resistance (PVRI) (2.43±1.0 Wood U · m2 versus 1.52±0.9 Wood U · m2, P=0.007).
The majority of patients at moderate altitude have favorable outcomes after BDG or Fontan palliation. Risk factors for palliation failure at elevated altitude include PAP >15 mm Hg, TPG >8 mm Hg, and PVRI >2.5 Wood U · m2.
PMCID: PMC3129266  PMID: 18824752
Fontan procedure; single ventricle; altitude

Results 1-9 (9)