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a Division of Cardiothoracic Surgery, Oregon Health and Science University, Portland, Oregon
b Division of Surgery, Oregon Health and Science University, Portland, Oregon
c Division of Pediatric Cardiothoracic Surgery, Department of Surgery, Case Western Reserve University, Cleveland, Ohio
d Mary Bridge/Swedish Pediatric Cardiothoracic Surgery Program, Mary Bridge Children's Hospital and Health Center, Multicare Health System, Tacoma, Washington
Accepted for publication February 26, 2010.
* Address correspondence to Dr Karamlou, Oregon Health and Science University, Division of Cardiothoracic Surgery, 3181 SW Sam Jackson Park Rd, Mail Code L-353, Portland, OR 97239 (Email: karamlou{at}ohsu.edu).
Presented at the Forty-fifth Annual Meeting of The Society of Thoracic Surgeons, San Francisco, CA, Jan 26–28, 2009.
| PEDIATRIC CARDIAC SURGERY:
The Annals of Thoracic Surgery CME Program is located online at http://cme.ctsnetjournals.org. To take the CME activity related to this article, you must have either an STS member or an individual non-member subscription to the journal.
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| Abstract |
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18 years) have widened without evidence identifying the ideal clinical environment. To elucidate the optimum care paradigm, we investigated whether mortality for patients with GUCH was influenced by the type of hospital where they had surgery, children's specialty hospital (CH) versus general hospital (GH), and by the clinical focus of the surgeon, congenital heart surgery (CHS) or noncongenital (adult acquired) heart surgery (NCHS). Methods: In the Nationwide Inpatient Sample 1988–2003, we identified index procedures in patients 18 or more years of age within 12 congenital cardiac disease diagnostic groups. The CHS surgeons were defined as those whose annual practice volume consisted of more than 75% pediatric cardiac operations. Four clinical environment combinations were constructed: CH plus CHS, CH plus NCHS, GH plus CHS, and GH plus NCHS. Years were grouped into quartiles to identify trends in management over time.
Results: In all, 29,070 operations occurred at GH and 10,971 occurred at CH. Unadjusted in-hospital mortality was lowest in the CH plus CHS environment (1.14%), and highest for in the GH plus CHS environment (9.93%; p < 0.001). After risk adjustment for patient factors, the CH plus CHS environment remained optimum, whereas the other three environments increased the risk of in-hospital death (GH plus NCHS: odds ratio 2.4 [95% confidence interval: 0.9 to 6.2]; CH plus NCHS: odds ratio 2.4 [95% confidence interval: 0.9 to 6.5]; GH plus CHS: odds ratio 9.1 [95% confidence interval: 3.0 to 27.6]). Over the study period, there was a dramatic rise in the number of GUCH patients treated in GH plus NCHS and CH plus NCHS, suggesting that the shift in clinical environment was provider specific rather than hospital-type specific.
Conclusions: Case mix varies with the clinical environment, with more complex procedures performed at GH plus CHS. The optimal environment for complex GUCH surgery involved CHS operating within CH. Initiatives to develop adult congenital centers dedicated to the care of GUCH patients are warranted, and should include congenital heart surgeons operating in a setting mimicking children's hospitals.
Owing to the improved outcomes for congenital heart surgery in the neonatal period, there is an increasing number of patients who are grown-ups with congenital heart disease (GUCH) [1–5]. The best estimates of the current population of GUCH patients came from the 32nd Bethesda Conference held in 2000, which projected that nearly 787,800 adult patients were living with congenital heart disease [1]. Many GUCH patients require ongoing specialized care and surgical intervention, and despite the notion of "adulthood," GUCH patients still offer unique physiologic and anatomic challenges consistent with congenital rather than adult acquired heart disease. However, as adults, GUCH patients may have important comorbidities such as renal failure, peripheral vascular disease, chronic obstructive pulmonary disease, deep venous thrombosis, and substance abuse, which are uncommon among children [6–8]. Rossano and colleagues [8] have shown that postoperative adverse events occur more frequently when GUCH patients are operated on at children's hospitals, especially in the setting of comorbidities. Because of these unique challenges that characterize GUCH, there has been a growing focus on developing specialized centers dedicated to the care of this population [1–4, 9–13]. Many large, academic centers have established so-called adult congenital centers that offer comprehensive care by cardiologists and surgeons who are familiar with the pathology, anatomy, and social issues facing GUCH patients [1–4, 12, 13]. We showed [14] that specialist care for GUCH patients reduced in-hospital mortality without a corresponding increase in hospital length of stay and total hospital charges. However, incompletely evaluated in our prior study was the influence of the hospital environment on both mortality and resource utilization. That is, congenital heart disease surgeons and adult acquired heart disease surgeons generally operate in different environments, and the surgeon themselves may in fact be surrogates for the "systems" or environment that they bring with them. We therefore undertook this study to determine national practice patterns for clinical environments utilized for the care of GUCH patients and to determine the ideal clinical environment for GUCH patients that would reduce in-hospital mortality.
| Material and Methods |
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Using this initial procedural dataset, we then incorporated 12 ICD-9-CM coded diagnoses adjudicated by consensus among the authors that capture the vast majority of GUCH [14]. However, because the Agency for Healthcare Research and Quality requirements prohibit reporting of cases with less than 10 counts, the following diagnoses were combined into a larger category labeled "all other diagnoses": hypoplastic left heart syndrome, D-transposition of the great arteries, L-transposition of the great arteries, double-outlet right ventricle, total anomalous pulmonary venous return, and ostium primum atrial septal defect. The GUCH operations were then defined as those operations within these specified 12 diagnoses performed in patients aged 18 years or more.
We then profiled individual surgeons by previously described methods [15]: surgeons were identified within the NIS based on the synthetic surgeon identifier (surgeon_ID), which is distinct from the attending physician identifier (phy_ID). Individual surgeons are unable to be traced over time within the NIS, and therefore we expressed concentration in pediatric heart surgery as a percentage of any individual surgeon's annual cardiac caseload. Congenital heart surgeons (CHS) were defined as surgeons whose annual practice consisted of 75% or more pediatric heart surgery (eg, operations undertaken in patients aged less than 18 years). Noncongenital heart surgeons (NCHS) were primarily adult acquired heart disease surgeons, therefore, whose annual practice volume consisted of less than 75% pediatric heart surgery. The 75% cutpoint was chosen based upon our prior publication elucidating the relationship between outcomes and surgeon specialty [15]. Owing to the nature of the NIS, whereby different hospitals are sampled in any given year, surgeon classification was based on annual volume for each individual year (ie, year specific).
Practice setting was defined based on the National Association of Children's Hospitals and related institutions (NACH) designation given to the hospital. This designation does not appear directly in the NIS; it was extracted from contemporaneous years of the Kids' Inpatient Database [17]. The National Association of Children's Hospitals designates hospitals as "not identified as a children's hospital," "children's general hospital," "children's specialty hospital," and children's unit in a general hospital." No children's specialty hospitals were present in these data. For the purposes of this analysis, children's general hospital and children's unit in a general hospital were considered equivalent (CH), and those not identified as a CH were considered general hospitals (GH). Cases in which we could not identify the practice setting (n = 74) were excluded from the analysis.
The surgeon classification and practice setting were combined to give four clinical environments: CH plus CHS, GH plus CHS, CH plus NCHS, and GH plus NCHS.
Statistical Analysis
The primary outcome was in-hospital mortality. Logistic regression models, adjusted for patient and hospital level characteristics, were fit to estimate the attributable risk as a result of operation within each of the four environments, and within children's hospitals compared with general hospitals (eg, irrespective of the surgeon specialty). We generated c-indices and receiver-operating characteristic curves for all logistic regression models to provide insight into model discrimination. We used SAS software, version 9.1 (SAS Institute, Cary, NC) to fit the models, accounting for the survey design of the NIS, the potential clustering of outcomes within a hospital, and the decrease in clustering occurring over increasing time intervals. Years were grouped into quartiles to identify trends over time. Our method of risk adjustment included fitting an initially saturated logistic regression model, using the following variables: clinical environment, era (year quartiles), all comorbidity measures, female sex, patient age (as a continuous variable and as a ranked quartile variable), and patient primary diagnostic group (tetralogy of Fallot, atrial septal defect [ASD], ventricular septal defect [VSD], or other). Manual stepwise backward selection was used excluding those variables with nonsignificant p values. Minimization of the information criteria (AIC, BIC) were used to evaluate model fit after exclusion of each variable, and the full model c-statistic was also assessed. Interaction terms were considered, and transformations of scale were used to improve calibration. The authors had full access to and take full responsibility for the integrity of the data. All authors have read and agreed to the manuscript as written.
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| Comment |
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We have also shown an increase in the number of GUCH patients operated on by NCHS over time irrespective of hospital type, whereas the prevalence of GUCH patients operated by CHS remained fairly constant. This trend is confirmed by our analysis of hospital type, which showed no significant increase in the proportion of patients treated at general hospitals compared with children's hospitals over the duration of the study period, suggesting that the shift in clinical environment is provider specific rather than hospital-type specific. This rise in treatment within an environment excluding CHS is particularly concerning in light of our prior report showing that operation by NCHS increases both in-hospital mortality and resource utilization [15].
The subject of the ideal clinical environment in which to care for GUCH patients has been incompletely evaluated, despite the rapidly growing GUCH population [6–8, 18]. Rossano and colleagues [8] recently described the risk of adverse events among 135 GUCH patients undergoing cardiac surgery at Texas Children's Hospital from 2000 to 2004. They found acceptable early mortality (1.5%), but a 24% prevalence of adverse events. We cannot directly compare the results of this study within the context of our present report, however, as management of GUCH patients at Texas Children's Hospital has evolved to include a multidisciplinary team of congenital heart surgeons and both adult and pediatric medical specialists [7]. A care paradigm involving a combination of specialists from both the adult and the pediatric realm is one possible solution, but may present unreasonable hurdles in institutions without a nearby or even adjoining children's hospital. Mahle and colleagues [6] used the Pediatric Health Information System database to determine outcomes among 719 adult patients (aged
21 years) treated at 37 children's hospitals in the United States. Overall mortality for their study population was 1.6%, although nearly half of the procedures identified in this study (n = 352) were pacemaker implantations/revisions or "other." Importantly, the prevalence of GUCH cases at the institutions sampled was uniformly low, ranging from 0% to 10.9%. These estimates agree with our findings that the minority of GUCH patients (less than 30%) even in the present era are cared for within a children's hospital setting. Given the data from the present study along with those from our prior report [15], such a trend is concerning.
Limitations
Our study has several limitations, many of which have been extensively covered in our prior reports [15, 19]. Concatenation of the current dataset required combining data from two large administrative datasets, which may inflate the prevalence of coding errors. Additionally, we could not include data from 74 admissions because of an inability to determine hospital type, raising the possibility that selection bias may have influenced our findings. Furthermore, because of the lack of time-date stamping, it is not possible to determine whether comorbidities identified in the NIS are admission diagnoses or after admission (or postprocedure) complications. Although it is not inherently problematic to compare populations of different sizes, large reduction in sample size, especially among the GH plus CHS group, which consisted of only 59 admissions, may have limited the power of our study by reducing the variability within this group.
In conclusion, despite these limitations, our study has demonstrated that in-hospital mortality for GUCH patients is lowest in a clinical environment where congenital heart surgeons operate within a children's hospital. Survival for GUCH patients is, therefore, influenced by both the specialization of the surgeon and the care setting. Dramatic increases in the number of GUCH patients cared for by surgeons without specialization in congenital heart surgery are not ideal and may contribute to worsening outcomes among this challenging population. Initiatives to develop adult congenital centers dedicated to the care of complex GUCH patients are warranted, and should include congenital heart surgeons operating in a setting mimicking children's hospitals.
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Secondly, was there any consideration to having a category for surgeons that are bona fide adult congenital surgeons, meaning that they performed, say, more than 150 adult and more than 150 congenital procedures per year? High-volume adult congenital surgeons don't fit in your category of congenital heart surgeons (>75%) because, ironically, they do too much adult congenital surgery. These few bona fide adult congenital surgeons are lumped in with literally thousands of adult surgeons doing a few atrial septal defects a year. Did your analysis allow you to look at bona fide congenital heart surgeons outcomes compared with the other two categories of surgeons?
Finally, what about the concept of a true adult congenital environment that's a combination facility, where all adult's and all children's operations are performed in the same operating room by a common team of anesthesiologists, surgeons, scrubs, and perfusionists. There are a few dozen such institutions in the United States and many are members of the American Congenital Heart Association. Did you consider comparing ACHA program results with your two hospital group's results?
DR KARAMLOU: Well, I'll take your last question first since it's foremost in my mind. We cannot answer that question with this data set. We have no idea which perfusionist did what and which anesthesiologist did what in these patients. Although I think your point is well taken, and this study by no means says that congenital heart surgeons in a children's hospital have to be the paradigm. I'm simply stating that in lieu of developing dedicated adult congenital centers, of which there are very few, especially in the United States, that is a model that based on this data set yields the best results.
And in regard to your other question, looking at dedicated adult congenital surgeons, that is something that we did in our original paper that was published in Circulation earlier this last year, and it's something that we could certainly extend to this hospital-level analysis. The problem with that is defining the surgeons who do enough adult congenital cases within this data set, and that proved problematic in our earlier analysis, although it's something that we could certainly look at.
Regarding your first question, I think it's very difficult. The STS congenital database right now does not include codes for adult congenital heart disease cases, and I think that we ought to develop initiatives to look at specifically this growing population of patients. And something like you're suggesting, I think, would take that type of data set to answer.
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