Risk Factors and Outcomes Associated with Gaps in Care in Children with Congenital Heart Disease.

Adults with congenital heart disease (CHD) benefit from cardiology follow-up at recommended intervals of ≤ 2 years. However, benefit for children is less clear given limited studies and unclear current guidelines. We hypothesize there are identifiable risks for gaps in cardiology follow-up in children with CHD and that gaps in follow-up are associated with differences in healthcare utilization. Our cohort included children < 10 years old with CHD and a healthcare encounter from 2008 to 2013 at one of four North Carolina (NC) hospitals. We assessed associations between cardiology follow-up and demographics, lesion severity, healthcare access, and educational isolation (EI). We compared healthcare utilization based on follow-up. Overall, 60.4% of 6,969 children received cardiology follow-up within 2 years of initial encounter, including 53.1%, 58.1%, and 79.0% of those with valve, shunt, and severe lesions, respectively. Factors associated with gaps in care included increased drive time to a cardiology clinic (Hazard Ratio (HR) 0.92/15-min increase), EI (HR 0.94/0.2-unit increase), lesion severity (HR 0.48 for shunt/valve vs severe), and older age (HR 0.95/month if < 1 year old and 0.94/year if > 1 year old; p < 0.05). Children with a care gap subsequently had more emergency department (ED) visits (Rate Ratio (RR) 1.59) and fewer inpatient encounters and procedures (RR 0.51, 0.35; p < 0.05). We found novel factors associated with gaps in care for cardiology follow-up in children with CHD and altered health care utilization with a gap. Our findings demonstrate a need to mitigate healthcare barriers and generate clear cardiology follow-up guidelines for children with CHD.

Third-Grade Academic Performance and Episodes of Cardiac Care Among Children with Congenital Heart Defects.

Children with congenital heart defects (CHDs) are at risk for poor academic performance. The degree to which receipt of health care services is associated with adverse academic outcomes is not known. We examined the association between episodes of cardiac care and third-grade performance in children with CHD. We identified subjects between 1/1/2008 and 4/30/2012 among 5 centers in North Carolina. We classified children by CHD type and linked subjects to the state educational records. Any inpatient or outpatient cardiac encounter on a date of service was considered an encounter. We calculated the number of encounters by adding the number of inpatient or outpatient cardiac visits prior to the date of the end-of-grade (EOG) tests. We estimated the odds of failing third-grade reading or math EOG tests by episodes of care stratified at the 50th percentile, controlling for CHD type, maternal education, sex, race/ethnicity, birth weight, and gestational age. A total of 184 children had third-grade EOG scores linked to health care records. The median number of episodes of care was 4 (range: 1-60). Those with visits ˃ 50th percentile (> 4 encounters/year over the 4.3 year observation period) had 2.09 (95% CI 1.04, 4.21) greater odds of failing the math EOG compared to those ≤ 50th percentile (1-4 encounters). The third-grade math score declined by 1.5 points (P < 0.008) for every 10 episodes of care. There was no association of episodes of care on third-grade reading performance. Children with CHD with > 4 episodes of cardiac care/year may be at risk for delays in third-grade academic performance. Strategies to minimize school absenteeism may improve academic success in this population.

Regionalization of congenital cardiac surgical care: what it will take.

PURPOSE OF REVIEW: Decentralized, inconsistent healthcare delivery results in variable outcomes and wastes nearly one trillion dollars annually in the United States (US). Congenital heart surgery (CHS) is not immune due to high, variable costs and inconsistent outcomes across hospitals. Many European countries and Canada have addressed these issues by regionalizing CHS. Centralizing resources lowers costs, reduces in-hospital mortality and improves long-term survival. Although the impact on travel distance for patients is limited, the effect on healthcare disparities requires study. This review summarizes current data and integrates these into paths to regionalization through health policy, research, and academic collaboration. RECENT FINDINGS: There are too many CHS programs in the US with unnecessarily high densities of centers in certain regions. This distribution lowers center and surgeon case volumes, creates redundancy, and increases variation in costs and outcomes. Simultaneously, adhering to suboptimal allocation impedes the understanding of optimal regionalization models to optimize congenital cardiac care delivery. SUMMARY: CHS regionalization models developed for the US increase surgeon and center volume, decrease healthcare spending, and improve patient outcomes without substantially increasing travel distance. Regionalization in countries with few or no existing CHS programs is yet to be explored, but may be associated with more efficient spending and procedural complexity expansion.

Does the pattern of bicuspid aortic valve leaflet fusion determine the success of the Ross procedure?

BACKGROUND: In addition to being associated with aortopathy, a bicuspid aortic valve (BAV) has been posed to be a risk factor for the dilation of the pulmonary autograft in the aortic position. The aim of this study is to assess the association between the subtype of native aortic valve leaflet fusion (right and noncoronary leaflets [R/N] vs right and left leaflets [R/L]) and autograft dilation and valve dysfunction after the Ross procedure. METHODS: We performed a retrospective review of 43 patients with BAV who underwent a Ross procedure in our center from 1993 to 2013. Serial transthoracic echocardiography was used to measure changes in autograft and ascending aortic diameter over time. The aortic diameter was measured at four levels, and Z values were computed. Aortic dilation was defined as a Z value greater than 3. RESULTS: The mean age at the time of the Ross procedure was 13.5 ± 9.2 years. R/L was the most prevalent native aortic valve subtype (R/L, n = 26, 61% vs R/N, n = 17, 39%). PreRoss procedure, aortic dilation was more frequent in patients with R/N fusion (P = .02), whereas the initial aortic valve gradient and grade of aortic insufficiency (AI) did not differ between the subgroups. At follow-up, (mean = 9.6 ± 4.3 years) dilation of the autograft and ascending aorta was seen more often in patients with R/N leaflet fusion (P = .03). Conversely, the prevalence of more than moderate AI was significantly higher in patients with R/L leaflet fusion (P = .03). There was no significant difference between groups among numbers of late reintervention on the aortic valve or root (P = .75); however the type of intervention varied by morphologic subtype. Patients with R/L fusion underwent more aortic valve replacements (AVRs) while patients with R/N fusion underwent more valve-sparing aortic root replacements. CONCLUSIONS: After Ross procedure, both groups of patients were likely to have a combination of dilation of the aortic root and the tubular portion of the ascending aorta at follow-up. Patients with R/L fusion were more likely to have a prevalence of root dilation, while patients with R/N fusion were more likely to have tubular ascending aorta dilation. The R/L phenotype is associated with a slightly more rapid dilation at follow-up and is more likely to have postoperative autograft insufficiency. This information may serve to guide patient and procedure selection for AVR.

Development of a clinical registry-based 30-day readmission measure for coronary artery bypass grafting surgery.

BACKGROUND: Reducing readmissions is a major healthcare reform goal, and reimbursement penalties are imposed for higher-than-expected readmission rates. Most readmission risk models and performance measures are based on administrative rather than clinical data. METHODS AND RESULTS: We examined rates and predictors of 30-day all-cause readmission following coronary artery bypass grafting surgery by using nationally representative clinical data (2008-2010) from the Society of Thoracic Surgeons National Database linked to Medicare claims records. Among 265 434 eligible Medicare records, 226 960 (86%) were successfully linked to Society of Thoracic Surgeons records; 162 572 (61%) isolated coronary artery bypass grafting admissions constituted the study cohort. Logistic regression was used to identify readmission risk factors; hierarchical regression models were then estimated. Risk-standardized readmission rates ranged from 12.6% to 23.6% (median, 16.8%) among 846 US hospitals with ≥30 eligible cases and ≥90% of eligible Centers for Medicare and Medicaid Services records linked to the Society of Thoracic Surgeons database. Readmission predictors (odds ratios [95% confidence interval]) included dialysis (2.02 [1.87-2.19]), severe chronic lung disease (1.58 [1.49-1.68]), creatinine (2.5 versus 1.0 or lower:1.49 [1.41-1.57]; 2.0 versus 1.0 or lower: 1.37 [1.32-1.43]), insulin-dependent diabetes mellitus (1.45 [1.39-1.51]), obesity in women (body surface area 2.2 versus 1.8: 1.44 [1.35-1.53]), female sex (1.38 [1.33-1.43]), immunosuppression (1.38 [1.28-1.49]), preoperative atrial fibrillation (1.36 [1.30-1.42]), age per 10-year increase (1.36 [1.33-1.39]), recent myocardial infarction (1.24 [1.08-1.42]), and low body surface area in men (1.22 [1.14-1.30]). C-statistic was 0.648. Fifty-two hospitals (6.1%) had readmission rates statistically better or worse than expected. CONCLUSIONS: A coronary artery bypass grafting surgery readmission measure suitable for public reporting was developed by using the national Society of Thoracic Surgeons clinical data linked to Medicare readmission claims.

Does the Homograft for RVOT Reconstruction in Ross: Patients Fare Better than for Non-Ross Patients? A Single-Center Experience.

BACKGROUND AND AIM OF THE STUDY: In patients undergoing the Ross procedure, the right ventricular outflow tract (RVOT) conduit is inserted in an orthotopic position rather than in the more heterotopic position used in the repair of complex congenital RVOT obstruction. The study aim was to compare the authors' institutional mid-term experience of large-sized homografts (>19 mm) in patients with Ross and non-Ross RVOT reconstructions. METHODS: The outcome was reviewed of all homografts implanted for Ross (n = 72) or non-Ross (n = 64) RVOT reconstruction at a single center between 1993 and 2012. Echocardiographic data were reviewed to evaluate valve performance. Homograft dysfunction was defined as RVOT obstruction with peak echo-Doppler gradient >40 mmHg and/or grade >III/IV conduit valve regurgitation. Homograft failure was defined as the need for conduit replacement or catheter or surgical reintervention. RESULTS: The age, body weight, conduit diameter and previous surgery were significantly higher in patients with Ross compared to the non-Ross group (p = 0.002, 0.003 and <0.001, respectively). The mean follow up duration was similar in both groups. There were 35 re-interventions (Ross, n = 17; non-Ross, n = 18). The data acquired showed actuarial survival, freedom from conduit dysfunction and conduit failure to be similar in both cohorts. Freedom from any type of reoperation was worse for the Ross group (58%) than for the non-Ross group (72%) (p = 0.05). CONCLUSION: During the first 15 years after Ross or non-Ross pulmonary homograft implantation, the survival rate, freedom from failure and dysfunction, and RVOT gradient were statistically similar. Freedom from any type of reoperation was significantly higher in the non-Ross group, however.

Outcomes of tricuspid valve repair in children with hypoplastic left heart syndrome.

OBJECTIVES: Tricuspid valve regurgitation (TR) is a common finding in children with hypoplastic left heart syndrome (HLHS) undergoing staged surgical reconstruction and can result from either abnormal valve morphology or incomplete leaflet coaptation due to annular dilatation. The purpose of this study was to determine the incidence of severe TR and to evaluate the effect of surgically treated tricuspid valve (TV) disease on overall survival. METHODS: Between December 1988 and December 2012, 86 patients with HLHS underwent a Norwood procedure (mean age/weight, 11.1 days/3.5 kg). Thirty-five percent had associated congenital cardiac, structural, and genetic anomalies. Subsequently, 65 patients underwent a bidirectional Glenn procedure or a hemi-Fontan (stage II) and 42 patients a modified Fontan procedure (stage III). The mean follow-up was 6.6 years. All patients were evaluated preoperatively and postoperatively by Doppler echocardiography to determine the degree of TR. RESULTS: At the time of discharge following the Norwood procedure, 64% (n = 47) of the patients had none/trivial, 32% (n = 24) had mild, 3% had moderate (n = 2), and 1% (n = 1) had severe TR on their post-Norwood Doppler echocardiograms. Among 74 Norwood survivors, 11 children (15%) with severe TR underwent TV repair at a median interval after the Norwood procedure of nine months (range, 2-70). There were one surgical and one late death, giving an overall mortality of 18%. The overall survival rate between TR and non-TR repair groups was not significantly different (p = 0.18). Four patients (36%) underwent reoperation for persistent TR. CONCLUSIONS: Severe TR as a risk factor for mortality in children undergoing palliative procedures for HLHS can be diminished by successful TV procedures. Survival at intermediate follow-up of patients with successful TV procedures that eliminate severe TR and patients without a history of severe TR are similar. Further follow-up is required to determine the impact of surgically treated TR on long-term survival and the durability of surgical techniques.

Ross procedure or mechanical aortic valve, which is the best lifetime option for an 18-year-old? A decision analysis.

Objectives: Identifying the optimal solution for young adults requiring aortic valve replacement (AVR) is challenging, given the variety of options and their lifetime complication risks, impacts on quality of life, and costs. Decision analytic techniques make comparisons incorporating these measures. We evaluated lifetime valve-related outcomes of mechanical aortic valve replacement (mAVR) versus the Ross procedure (Ross) using decision tree microsimulations modeling. Methods: Transition probabilities, utilities, and costs derived from published reports were entered into a Markov model decision tree to explore progression between health states for hypothetical 18-year-old patients. In total, 20,000 Monte Carlo microsimulations were performed to model mortality, quality-adjusted-life-years (QALYs), and health care costs. The incremental cost-effectiveness ratio (ICER) was calculated. Sensitivity analyses was performed to identify transition probabilities at which the preferred strategy switched from baseline. Results: From modeling, average 20-year mortality was 16.3% and 23.2% for Ross and mAVR, respectively. Average 20-year freedom from stroke and major bleeding was 98.6% and 94.6% for Ross, and 90.0% and 82.2% for mAVR, respectively. Average individual lifetime (60 postoperative years) utility (28.3 vs 23.5 QALYs) and cost ($54,233 vs $507,240) favored Ross over mAVR. The average ICER demonstrated that each QALY would cost $95,345 more for mAVR. Sensitivity analysis revealed late annual probabilities of autograft/left ventricular outflow tract disease and homograft/right ventricular outflow tract disease after Ross, and late death after mAVR, to be important ICER determinants. Conclusions: Our modeling suggests that Ross is preferred to mAVR, with superior freedom from valve-related morbidity and mortality, and improved cost-utility for young adults requiring aortic valve surgery.

Contemporary Relationship Between Hospital Volume and Outcomes in Congenital Heart Surgery.

BACKGROUND: Studies examining the volume-outcome relationship in congenital heart surgery (CHS) are more than a decade old. Since then, mortality has declined, and case-mix adjustment has evolved. We determined the current relationship between hospital CHS volume and outcomes. METHODS: Patients aged ≤18 years undergoing index operations in The Society of Thoracic Surgeons-Congenital Heart Surgery Database (2017-2020) were included. Associations between annual hospital volume and case-mix-adjusted operative mortality, major complications, failure to rescue (FTR), and postoperative length of stay (PLOS) were assessed using Bayesian hierarchical models, overall, by The Society of Thoracic Surgeons-European Association for Cardio-Thoracic Surgery (STAT) category, and for the Norwood procedure. RESULTS: Across 101 centers (76,714 index operations), median annual volume was 144 operations/y. Operative mortality was 2.7%. Lower-volume hospitals had higher mortality, with an apparent transition zone at ∼190 operations/y (95% credible interval [CrI], 115-450 operations/y), below which a sustained uptick in the estimated odds of death occurred. Odds of death compared with a 450 operations/y reference were 50 operations/y (odds ratio [OR], 1.84; 95% CrI, 1.41-2.37), 100 operations/y (OR, 1.37; 95% CrI, 1.08-1.71), 200 operations/y (OR, 0.92; 95% CrI, 0.1-1.18), 300 operations/y (OR, 0.89; 95% CrI, 0.76-1.04). The volume-outcome effect was more apparent for STAT 4 to 5 than STAT 1 to 3 operations. In the overall cohort, PLOS and complications were similar across hospital volumes, whereas FTR rates were higher at lower-volume hospitals. Lower-volume hospitals had worse outcomes after the Norwood procedure, most notably mortality and FTR. CONCLUSIONS: Hospital volume is associated with mortality and FTR after CHS. The relationship is strongest for high-risk operations. These data can inform ongoing initiatives to improve CHS care.

Recommendations for Centers Performing Pediatric Heart Surgery in the United States.

Care and outcomes for the more than 40,000 patients undergoing pediatric and congenital heart surgery in the United States annually are known to vary widely. While consensus recommendations have been published across numerous fields as one mechanism to promote a high level of care delivery across centers, it has been more than two decades since the last pediatric heart surgery recommendations were published in the United States. More recent guidance is lacking, and collaborative efforts involving the many disciplines engaged in caring for these children have not been undertaken to date. The present initiative brings together professional societies spanning numerous care domains and congenital cardiac surgeons, pediatric cardiologists, nursing, and other healthcare professionals from diverse programs around the country to develop consensus recommendations for United States centers. The focus of this initial work is on pediatric heart surgery, and it is recommended that future efforts focus in detail on the adult congenital population. We describe the background, rationale, and methodology related to this collaborative effort, and recommendations put forth for Essential Care Centers (essential services necessary for any program), and Comprehensive Care Centers (services to optimize comprehensive and high-complexity care), encompassing structure, process, and outcome metrics across 14 domains.

Recommendations for centers performing pediatric heart surgery in the United States.

Care and outcomes for the more than 40,000 patients undergoing pediatric and congenital heart surgery in the United States annually are known to vary widely. While consensus recommendations have been published across numerous fields as one mechanism to promote a high level of care delivery across centers, it has been more than two decades since the last pediatric heart surgery recommendations were published in the United States. More recent guidance is lacking, and collaborative efforts involving the many disciplines engaged in caring for these children have not been undertaken to date. The present initiative brings together professional societies spanning numerous care domains and congenital cardiac surgeons, pediatric cardiologists, nursing, and other healthcare professionals from diverse programs around the country to develop consensus recommendations for United States centers. The focus of this initial work is on pediatric heart surgery, and it is recommended that future efforts focus in detail on the adult congenital population. We describe the background, rationale, and methodology related to this collaborative effort, and recommendations put forth for Essential Care Centers (essential services necessary for any program), and Comprehensive Care Centers (services to optimize comprehensive and high-complexity care), encompassing structure, process, and outcome metrics across 14 domains.

Recommendations for Centers Performing Pediatric Heart Surgery in the United States.

Care and outcomes for the more than 40,000 patients undergoing pediatric and congenital heart surgery in the United States annually are known to vary widely. While consensus recommendations have been published across numerous fields as one mechanism to promote a high level of care delivery across centers, it has been more than two decades since the last pediatric heart surgery recommendations were published in the United States. More recent guidance is lacking, and collaborative efforts involving the many disciplines engaged in caring for these children have not been undertaken to date. The present initiative brings together professional societies spanning numerous care domains and congenital cardiac surgeons, pediatric cardiologists, nursing, and other healthcare professionals from diverse programs around the country to develop consensus recommendations for United States centers. The focus of this initial work is on pediatric heart surgery, and it is recommended that future efforts focus in detail on the adult congenital population. We describe the background, rationale, and methodology related to this collaborative effort, and recommendations put forth for Essential Care Centers (essential services necessary for any program), and Comprehensive Care Centers (services to optimize comprehensive and high-complexity care), encompassing structure, process, and outcome metrics across 14 domains.

Regional variation in prosthesis choice for aortic valve replacement in older patients.

BACKGROUND AND AIM OF THE STUDY: The study aim was to investigate regional practice patterns regarding aortic valve replacement (AVR) by comparing bioprosthetic versus mechanical valve usage in patients aged > or = 65 years, and to determine whether the choice of valve type for AVR in these patients varied by geographic region. METHODS: The details were acquired of all mechanical and bioprosthetic AVRs performed in patients aged > or = 65 years between 1999 and 2006, as contained in the Florida State Inpatient Database. By using a small area analysis, the patients' zip codes were aggregated into hospital referral regions based on where they were most likely to receive AVR. The regional rates of both mechanical and bioprosthetic AVR were then determined. RESULTS: Of 23,925 AVRs performed during this period, 15,368 involved a bioprosthetic aortic valve and 8,557 a mechanical aortic valve. Statewide, 64% of AVRs in these patients involved a bioprosthesis. Regional rates of mechanical AVRs varied widely, from 10% to 81%. CONCLUSION: Substantial regional differences were identified in practice patterns for AVR in patients aged > or = 65 years. This suggested that provider preference, in addition to patient pathology, would often determine the type of valve implanted.

Factors associated with mortality or transplantation versus Fontan completion after cavopulmonary shunt for patients with tricuspid atresia.

OBJECTIVE: Tricuspid atresia with normally related great vessels (TA) is considered the optimal substrate for the Fontan pathway. The factors associated with death or transplantation after cavopulmonary shunt (CPS) are underappreciated. We aimed to determine factors associated with CPS-Fontan interstage death/transplantation versus transition to Fontan in TA. METHODS: A total of 417 infants younger than 3 months of age with TA were enrolled (January 1999 to February 2020) from 40 institutions into the Congenital Heart Surgeons' Society TA cohort. Parametric competing risk methodology was used to determine factors associated with the competing end points of death/transplantation without Fontan completion, and transition to Fontan. RESULTS: CPS was performed in 382 patients with TA; of those, 5% died or underwent transplantation without transition to Fontan and 91% transitioned to Fontan by 5 years after CPS. Prenatal diagnosis (hazard ratio [HR], 0.74; P < .001) and pulmonary artery band (PAB) at CPS (HR, 0.50; P < .001) were negatively associated with Fontan completion. Preoperative moderate or greater mitral valve regurgitation (HR, 3.0; P < .001), concomitant mitral valve repair (HR, 11.0; P < .001), PAB at CPS (HR, 3.0; P < .001), postoperative superior vena cava interventions (HR, 9.0; P < .001), and CPS takedown (HR, 40.0; P < .001) were associated with death/transplantation. CONCLUSIONS: The mortality rate after CPS in patients with TA is notable. Those with preoperative mitral valve regurgitation remain a high-risk group. PAB at the time of CPS being associated with both increased risk of death and decreased Fontan completion may represent a deleterious effect of antegrade pulmonary blood flow in the CPS circulation.

Disparities in Loss to Follow-Up Among Adults With Congenital Heart Disease in North Carolina.

BACKGROUND: The AHA/ACC Adult Congenital Heart Disease guidelines recommend that most adults with congenital heart disease (CHD) follow-up with CHD cardiologists every 1 to 2 years because longer gaps in care are associated with adverse outcomes. This study aimed to determine the proportion of patients in North Carolina who did not have recommended follow-up and to explore predictors of loss to follow-up. METHODS: Patients ages ≥18 years with a healthcare encounter from 2008 to 2013 in a statewide North Carolina database with an ICD-9 code for CHD were assessed. The proportion with cardiology follow-up within 24 months following index encounter was assessed with Kaplan-Meier estimates. Cox regression was utilized to identify demographic factors associated with differences in follow-up. RESULTS: 2822 patients were identified. Median age was 35 years; 55% were female. 70% were white, 22% black, and 3% Hispanic; 36% had severe CHD. The proportion with 2-year cardiology follow-up was 61%. Those with severe CHD were more likely to have timely follow-up than those with less severe CHD (72% vs 55%, P < .01). Black patients had a lower likelihood of follow-up than white patients (56% vs 64%, P = .01). Multivariable Cox regression identified younger age, non-severe CHD, and non-white race as risk factors for a lower likelihood of follow-up by 2 years. CONCLUSION: 39% of adults with CHD in North Carolina are not meeting AHA/ACC recommendations for follow-up. Younger and minority patients and those with non-severe CHD were particularly vulnerable to inadequate follow-up; targeted efforts to retain these patients in care may be helpful.

Long-term results after Carpentier-Edwards pericardial aortic valve implantation, with attention to the impact of age.

BACKGROUND: The purpose of this study was to determine long-term patient survival and valve durability for Carpentier-Edwards pericardial valves (Edwards Lifesciences) implanted in the aortic position, with specific attention to the impact of patient age. METHODS: We performed a retrospective cohort study of 2168 patients who underwent implantation of a Carpentier-Edwards pericardial aortic valve between 1991 and 2008. The mean follow-up time was 4.5 years. Primary outcomes of interest were mortality and valve explantation. Survival curves and event-free curves were obtained with the Kaplan-Meier method and compared with the log-rank test. RESULTS: Survival was 92% at 1 year, 73% at 5 years, 38% at 10 years, and 18% at 15 years. Although the mortality rate of younger patients was worse than in the general population, older patients had significantly better survival than their contemporaries. Age was the independent variable most significantly associated with explantation. There was an early hazard phase for patients between 21 and 49 years of age, such that the freedom from explantation was 89% at 3 years. By 10 years, the freedom from explantation was 58% for patients 21 to 49 years of age, compared with 68% for patients 50 to 64 years, 93% for patients 65 to 74 years, and 99% for patients 75 years of age and older. CONCLUSION: We found good long-term survival and durability. Older patients had excellent freedom from explantation, whereas younger patients fared worse. As our population ages, this information becomes increasingly important. Assessing the durability of this pericardial aortic valve may aid in predicting the durability of the transcatheter aortic valves that share the same leaflets.

Geography or pathology? Regional variation in atrial septal defect closure rates and techniques.

BACKGROUND: Since the introduction of percutaneous closure in the United States, rates of secundum atrial septal defect and patent foramen ovale closures have increased substantially. Whether or not closure rates are uniform or vary due to differences in regional practice patterns is unknown. We sought to investigate this by comparing regional rates of closure across Florida. METHODS: We identified all atrial septal defect closures from 2001 to 2006 in the Florida State Inpatient Database. Using small area analysis, zip codes were assigned to Hospital Referral Regions based on where patients were most likely to go for closure. We obtained population-normalised rates of overall, percutaneous, and surgical closure. RESULTS: Of 1830 atrial septal defect and patent foramen ovale closures from 2001 to 2006, 751 were surgical and 1004 were percutaneous. The statewide closure rate was 1.91 per 100,000 people per year; regional rates varied 3.8-fold from 0.78 to 2.94 per 100,000 people per year. Percutaneous rates varied sevenfold from 0.25 to 1.75 per 100,000 people per year, while surgical rates varied 2.71-fold from 0.53 to 1.44 per 100,000 people per year. CONCLUSIONS: Despite a consistent prevalence of atrial septal defects, and patent foramens ovale, rates of repair vary across regions, suggesting that closure is driven by provider practice patterns rather than patient pathology. Efforts should be directed towards increasing consensus regarding the appropriate, evidence-based indications for closure so as to avoid the costs and potential negative sequelae of over- or undertreatment.

Theoretical Model for Delivery of Congenital Heart Surgery in the United States.

BACKGROUND: Over 150 hospitals perform congenital heart surgery (CHS) in the United States. Many hospitals are close together, with a median patient travel distance of 38.5 miles. We began with a theoretical blank slate and used objective methodology guided by population density and volume thresholds to estimate the optimal number and locations of hospitals to provide CHS in the United States. METHODS: Guided by published data, we estimated the number of CHS operations in the United States in to be 32,500 per year. We distributed patients geographically based on population density. Metropolitan Statistical Areas (population centers and surrounding areas with close economic/social ties) were used as potential hospital locations. Patients were assigned to the closest hospital location such that all hospitals had a CHS volume of ≥300 operations. RESULTS: We estimated 57 hospitals could serve the contiguous United States. Median theoretical hospital volume after regionalization was 451 operations (interquartile range, 366-648). Median patient travel distance was 35.1 miles. Some patients (6396/31,895, 20%) traveled more than 100 miles. CONCLUSIONS: Our model suggests the United States could be served by approximately 100 fewer CHS hospitals than currently exist. With hospitals optimally placed, patient travel burden would decrease. This model serves as a platform to improve care delivery by regionalization of CHS.

Linking clinical registry data with administrative data using indirect identifiers: implementation and validation in the congenital heart surgery population.

BACKGROUND: The use of clinical registries and administrative data sets in pediatric cardiovascular research has become increasingly common. However, this approach is limited by relatively few existing datasets, each of which contain limited data, and do not communicate with one another. We describe the implementation and validation of methodology using indirect patient identifiers to link The Society of Thoracic Surgeons Congenital Heart Surgery (STS-CHS) Database to The Pediatric Health Information Systems (PHIS) Database (a pediatric administrative database). METHODS: Centers submitting data to STS-CHS and PHIS during 2004 to 2008 were included (n=30). Both data sets were limited to patients 0 to 18 years old undergoing cardiac surgery. An exact match was defined as an exact match on each of the following: date of birth, date of admission, date of discharge, sex, and center. Likely matches were defined as an exact match for all variables except ±1 day for one of the date variables. RESULTS: Of 45,830 STS-CHS records, 87.4% matched to PHIS using the exact match criteria and 90.3% using the exact or likely match criteria. Validation in a subset of patients revealed that 100% of exact and likely matches were true matches. CONCLUSIONS: This analysis demonstrates that indirect identifiers can be used to create high-quality link between a clinical registry and administrative data set in the congenital heart surgery population. This methodology, which can also be applied to other data sets, allows researchers to capitalize on the strengths of both types of data and expands the pool of data available to answer important clinical questions.

Chance, bias, and confounding: threats to valid measurement of quality in the context of pediatric cardiac surgery.

Assessment of quality in pediatric cardiac surgery has frequently been an add-on to efforts to measure adult cardiac surgery, without sufficient acknowledgement of the differences between the specialties. As a result, data reporting has often proceeded without adequate attention to data analysis. Assessment of clinical outcomes relies on the methods of observational epidemiology. Interpretation of the results of such investigations requires an understanding of the limitations inherent in the design of observational studies: chance, bias, and confounding. These limitations are of particular importance when studying pediatric cardiac surgery because of the relatively low number of cases performed at any one institution or by any one surgeon, the diversity of operations, and the heterogeneity of the congenital cardiac patient population.