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Ann Thorac Surg 2007;84:147-155
© 2007 The Society of Thoracic Surgeons

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Original Articles: Cardiovascular

Complications and Risk Factors for Mortality During Congenital Heart Surgery Admissions

^a Department of Cardiology, Children’s Hospital Boston, Boston, Massachusetts
^b Department of Cardiac Surgery, Children’s Hospital Boston, Boston, Massachusetts

Accepted for publication February 21, 2007.

^_* Address correspondence to Dr Jenkins, Department of Cardiology, Children’s Hospital Boston, 300 Longwood Avenue, Boston, MA 02115 (Email: kathy.jenkins{at}cardio.chboston.org).

For editorial comment, see page 1

 

	Abstract

Top Abstract Introduction Material and Methods Results Comment References

 
Background: We have previously reported a high rate (32%) of complications among congenital heart surgery admissions. The association among reported complications and other risk factors for mortality during congenital heart surgery admissions has not been assessed.

Methods: We identified congenital heart surgery admissions, ages less than 18 years, within the Kids’ Inpatient Database 2000, and applied a complication screening method using "International Classification of Disease, 9^th Revision, Clinical Modification." Complication diagnoses were classified into four categories, complications due to the following: (1) drugs; (2) procedures; (3) devices, implants, and grafts; and (4) radiation. We examined the independent effect of a complication diagnosis code and complication subcategory on mortality using generalized estimating equations controlling for case-mix using the Risk Adjustment for Congenital Heart Surgery (RACHS-1) method, as well as other previously reported predictors for mortality.

Results: Among the 10,032 congenital heart surgical admissions, 32% had at least one complication diagnosis. Seventy-eight percent of complication diagnoses were procedure related, 18% device, implant, or graft related, and 4% drug related. There were no radiation complications identified. After adjusting for case-mix, gender, race, insurance, and hospital surgical volume, admissions with a complication diagnosis had a substantially greater odds of death compared with admissions without a complication (odds ratio [OR] 2.4, p < 0.001). Among complication subcategories, procedure (OR 2.3, p < 0.001), and device, implant, or graft (OR 2.7, p < 0.001) related complications contributed to higher death risk.

Conclusions: Complication diagnoses occur frequently during congenital heart surgery admissions and are associated with an increased risk of death even after controlling for other known mortality risk factors. Identification of complication diagnoses is an important first step. Subsequent efforts must further examine these events to determine their degree of preventability and develop strategies to reduce them. Such an effort may reduce death in this vulnerable population. This study represents preliminary work in an effort to improve outcomes in this complex patient population.

We have found that nearly one-third of congenital heart surgery admissions have a reported complication diagnosis [1, 2]. Congenital heart disease remains the number one medical cause of death for children under age 15 years [3]. The underlying hemodynamic and physiologic instability of many children with congenital heart disease may make these patients particularly vulnerable to any adverse event. Given that repair of most congenital heart defects invariably involves complex surgical procedures, catheter-based interventions, and specialized intensive medical care, we hypothesized that complications during such admissions further place infants and children at high risk for death (Fig 1) [4].

View larger version (18K): [in this window] [in a new window]   Fig 1. Conceptual framework of congenital heart surgery admissions and the relationship of complication diagnoses and death risk. Patients undergoing congenital heart surgery have a baseline risk for mortality during admissions for congenital heart surgery (solid line) based on a number of risk factors (age, gender, surgical case complexity, prematurity, presence of major noncardiac structural anomalies, race, insurance type, hospital surgical volume). We hypothesize the presence of a complication diagnosis will increase the risk for death independently of other known death risk factors (striped line). That is, complication diagnoses shift this baseline death risk up higher, regardless of patient risk factors.

	Material and Methods

Top Abstract Introduction Material and Methods Results Comment References

 
Data Source
Data were obtained from the Healthcare Cost and Utilization Project (HCUP) Kids’ Inpatient Database (KID) 2000. The KID database was designed by the Agency for Healthcare Research and Quality (AHRQ) specifically to examine issues pertinent to health care delivery in children and consists of a stratified random sample of 2,516,833 admissions from 2,784 institutions in 27 states (Arizona [AZ], California [CA], Colorado [CO], Connecticut [CT], Florida [FL], Georgia [GA]), Hawaii [HI], Iowa [IA], Kansas [KS], Kentucky [KY], Maine [ME], Maryland [MD], Massachusetts [MA], Missouri [MI], North Carolina [NC], New Jersey [NJ], New York [NY], Oregon [OR], Pennsylvania [PA], South Carolina [SC], Tennessee [TN], Texas [TX, Utah [UT], Virginia [VA], Washington [WA], Wisconsin [WI], and West Virginia [WV]) from the year 2000. Pediatric hospitals, academic medical centers, and specialty hospitals were included. The database includes a 10% sample of uncomplicated in-hospital births from these institutions, and an 80% sample of other pediatric admissions (age < 21 years). Standard demographic and administrative data including age, gender, race, admission type, insurance type, median income of a patient’s zip code, discharge status, and up to 15 discharge diagnostic codes and 15 procedure codes based on the ICD-9-CM are included.

Congenital Heart Surgery Case Selection
Patients less than 18 years of age were identified from all hospital admissions with ICD-9-CM codes indicating surgical repair of a congenital heart defect. We excluded transcatheter closure of atrial septal defects, ventricular septal defects, patent ductus arteriosus (PDA), and balloon atrial septectomy, vessel repair, or occlusion by eliminating those procedures with concomitant catheterization codes and no code for cardiopulmonary bypass. Our method of congenital heart surgical case selection has been previously described [10, 11].

Identification of ICD-9-CM Codes Indicating Complication
Complications diagnoses were identified by ICD-9-CM codes using a surveillance method published by the AHRQ that has been validated in a pediatric population [8]. In our report we will use the term "complication" for these unwanted patient events as it is the common term used by those caring for children with congenital heart disease. This surveillance method defines these unwanted events as "any untoward harm associated with a therapeutic or diagnostic healthcare intervention" [8]. Complications may occur at any point during the patient’s admission (during anesthesia, catheterization, patient transport, surgery, intensive care unit care, inpatient ward). Designation of an event as a complication does not signify that the event was preventable nor due to substandard care. That is, although some of these events may represent preventable or modifiable complications, others may be an unavoidable part of the patient’s disease process. Not only are many of these complications not preventable (because they are an unavoidable part of the patient’s disease process), but many of these complications are also not associated with medical error.

The list of ICD-9-CM codes indicating a complication diagnosis has been published [9]. This method was created by a multidisciplinary group, including physicians, nurses, statisticians, a medical technologist, and epidemiologists, that identified ICD-9-CM codes indicative of complication and then validated their choices using a detailed medical record review. Using the chart review by an experienced research nurse and two-physician review as the standard for the identification of complication, this method had a sensitivity of 60% and specificity of 97% to distinguish among cases with and without a complication diagnosis [8]. Complication diagnoses were classified into four broad categories [8]: (1) drugs; (2) procedures; (3) devices, implants, and grafts; and (4) radiation. A given admission could have more than one complication diagnosis. We chose this method based on its comprehensiveness, applicability to large administrative databases, and prior validation and use in a pediatric discharge database.

Adjustment for Known Predictors of Death After Congenital Heart Surgery
The RACHS-1 method was previously developed and validated to adjust for differences in case mix when examining in-hospital death rates after congenital heart surgery. The development and validation of RACHS-1 and its ability to predict patients at greater risk for mortality has been previously described [10, 11]. To use RACHS-1, congenital heart surgical cases are assigned to one of six risk categories based on the presence or absence of specific diagnosis and procedure codes, where category 1 has the lowest risk of death and category 6 the highest. Cases with combinations of cardiac surgical procedures were placed in the category corresponding to the single highest risk procedure. Additional clinical variables included as part of RACHS-1 were the following: age group (less than or equal to 30 days, 31 days to one year, and greater than or equal to one year: because CT, FL, MA, SC, and TX do not report age in days for patients ages less than one year, age group was categorized as less than one year versus greater than or equal to one year in these five states); prematurity; the presence of a major noncardiac structural anomaly in addition to the cardiac defect; and the presence of combinations of cardiac procedures [10, 11]. Cases that are ineligible for RACHS-1 categorization are patients 18 years or greater (adults), or cardiac transplantation or premature PDA. For cardiac transplantation and premature PDA cases typically other patient comorbidities are responsible for mortality. Cases not categorized by RACHS-1 are cases where the ICD-9-CM code is unclear or vague and the surgical procedure performed cannot be determined; eg, ICD-9-CM code 39.49 "Other revision of vascular procedure." These methods have been previously discussed [10, 11]. To study the independent effect of complication diagnosis code on mortality, we sought to additionally control for previously reported risk factors for death after congenital heart surgery; gender [12], race and ethnicity [13, 14], insurance [15], and hospital surgical volume [16].

Data Analysis
Analyses were limited to congenital heart surgical admissions that could be assigned to a RACHS-1 risk category. Rates of complication diagnoses were reported as number of complications per 1,000 admissions. An admission may have had more than one complication diagnosis. Complications were stratified according to the four categories. The univariate relationship between each risk factor for mortality (risk category, age, prematurity, presence of a major noncardiac structural anomaly [10], gender [12], race and ethnicity [13], insurance [15], and hospital surgical volume [16]) and any complication diagnosis was explored using a ² test. The univariate relationship between complication diagnosis and death was also examined using generalized estimating equations (GEE). Multivariate analyses, using GEE incorporating RACHS-1 variables to adjust for baseline mortality risk, were performed to estimate the independent effect of complication diagnosis on odds of death. The GEE models account for the intrainstitutional correlation among cases from the same hospital. A second model explored potential confounding by gender, race, insurance, and hospital surgical volume, in addition to the RACHS-1 variables. Additional analyses also estimated the independent effect of a complication subcategory and number of complication diagnoses on risk of death. Odds ratios (OR) estimating the risk of death for cases with a complication diagnosis compared with noncomplication cases were calculated.

	Results

Top Abstract Introduction Material and Methods Results Comment References

 
Table 1 lists the characteristics of our study sample. Among the 12,717 congenital heart surgery cases in the KID 2000 database, 10,032 congenital heart surgical admissions met our inclusion criteria; 1,336 were ineligible for RACHS-1 categorization and 1,349 congenital heart surgery cases could not be assigned to a RACHS-1 risk category due to vague or unclear coding of the surgical procedure. Of these admissions meeting criteria, 3,159 (32%) had at least one complication ICD-9-CM code. A total of 5,242 complication diagnosis codes were present, giving a rate of 523 complication diagnoses per 1,000 admissions. Complications were procedure related 78% of the time and procedure related complications occurred at a rate of 408 per 1,000 admissions; device, implant, or graft related 18%, 96 per 1,000; drug related 4%, 19 per 1,000; no radiation complication codes were identified. Among admissions with a complication, nearly one-half (48%) had more than one complication. Table 2 illustrates the 10 most frequently reported complication ICD-9-CM codes. These ten complication diagnosis codes comprised 70% of all complication ICD-9-CM codes.

Even after risk adjustment using RACHS-1 variables (risk category, age, prematurity, presence of major noncardiac structural anomaly, and the presence of combination of cardiac surgical procedures), admissions with a complication diagnosis code had more than a twofold risk of death (OR 2.2, p < 0.001). This effect remained significant and increased slightly in magnitude after additionally controlling for gender, race, insurance, and hospital surgical volume (OR 2.4, p < 0.001) (Table 4).

	Comment

Top Abstract Introduction Material and Methods Results Comment References

The magnitude of the association of a complication diagnosis on death risk makes complication diagnoses among the most important risk factors for death in this population reported in the literature, similar to the effect of annual case volume [16]. Chang and colleagues [12] examined nearly 6,600 discharges of congenital heart surgery and after controlling for multiple variables this study demonstrated that female patients had 51% greater odds of death than males. Gonzalez and colleagues [13] found that within Massachusetts, Black race was associated with an increased mortality compared with whites after adjusting for surgical case complexity. DeMone and colleagues [15] reported that Medicaid recipients have a higher risk of death after congenital heart surgery compared with those with commercial insurance. Jenkins and colleagues [16] studied cases of congenital heart surgery at 37 centers and demonstrated that the risk of in-hospital death was increased if the surgery was performed at a low volume institution. Although gender [12], race and ethnicity [13], and insurance [15] have been reported to be associated with higher death risk, the effect of a complication was greater in magnitude. In addition, the association between complication diagnosis and death was independent of these other factors, including hospital surgical volume. In fact, complications diagnoses were more commonly reported at centers with larger case volumes. This finding could be the result of better reporting by high volume institutions; however, this cannot be verified with this dataset. Better reporting may also explain the apparent paradox of high volume institutions despite reporting a higher rate of complication diagnoses having lower mortality. Alternatively, one may speculate that high volume centers may in fact have more complications due to the complex setting of care but are better equipped to rescue patients from such events.

Other authors have performed comprehensive analyses of adverse events and their association with mortality using similar methods for identifying adverse events in a pediatric population. Patient safety indicators (PSI) were developed as a means to screen for adverse events although the validity of PSIs has come under some scrutiny [5, 17]. Miller and Zhan [6] studied PSI events among admissions ages less than 18 years from a 1997 HCUP discharge database. This study found that admissions with PSI events have a twofold to 18-fold greater mortality. Another study by this group, using a 2000 HCUP database, replicated these findings and demonstrated a significant association between patient safety events and mortality.

Similarly, Slonim and colleagues [7] reported on complications in non-newborn pediatric medical discharges using HCUP databases from 1988, 1991, 1994, and 1997. This group identified complications using a limited number of ICD-9-CM codes indicating a complication. Their analyses demonstrated that admissions with complications had approximately twofold greater odds for in-hospital death compared with cases without complications. This finding was stable over the four years studied. Our findings are consistent with the findings of these authors, both in terms of the presence of a relationship between complication and mortality and the magnitude of its effect.

In our study we found that nearly one-third of congenital heart surgery admissions had at least one complication. Although there are no comprehensive studies of complication diagnoses during congenital heart surgery admissions, studies have examined selected types of complications. For example, studies examining nosocomial infections during congenital heart surgery admissions have reported that up to 22% of these patients acquired at least one nosocomial infection [18–20]. Among pediatric cardiac intensive care unit admissions, 18% experienced an arrhythmia related to their medical or surgical intervention [21]. The rates of other selected complication during congenital heart surgery admissions have been reported; hepatic complication 9% [22], cardiac tamponade 7% [23], and diaphragmatic paralysis 5.4% [24]. There are also many case reports of isolated adverse events [25–31]. These studies use different methods of identifying these events; however, their results support our findings that adverse events occur frequently.

We applied well established methodology to examine the association of complication diagnoses and mortality. Our data were obtained from a pediatric discharge database created specifically to examine health outcomes within pediatrics. This database reported a mortality rate of 4%, which is identical to the mortality rate reported in the Society of Thoracic Surgeons database for pediatric congenital heart surgery, thereby supporting the validity of the database employed in this study [32]. We used a complication surveillance method that has been previously validated in a general pediatric discharge database. Our population selection has been well-established; we applied a validated method to risk-adjust for case-mix in examining mortality. Furthermore, we adjusted for other previously reported predictors of mortality after congenital heart surgery. As a result our finding that complication diagnoses are associated with mortality is well supported. Further, the patterns of complication diagnoses identified predominantly related to procedures or devices, and are consistent with the complex care encompassed by congenital heart operations and recovery.

Despite the strengths of our methodology and the consistency of our findings, some limitations should be specifically delineated. Administrative data provide limited clinical information and may have problems in coding accuracy, variation, and limited insight into timing and severity of events [33]. The complication identification method used in this study not only has a low sensitivity but was also not specifically designed to identify complications during congenital heart surgery admissions. No such method currently exists. As a result these criteria may identify certain events as complications that may be unimportant or an unavoidable event related to a patient’s underlying disease. It is possible that this method excludes important events. As a result it is possible that too few events are included by this method and the presented findings underestimate the rate of these events. Additionally, whether complications occurred as the inciting mechanism for death or during interventions attempting to rescue a patient from death could not be explored. Finally, whether these complications were potentially preventable or associated with medical error could not be explored. Not all of these events coded as complications are preventable or associated with medical error. Methodology needs to be developed that will identify and document the subset of these events coded as complications that are preventable. Strategies must then be developed to reduce these preventable complications.

Despite the limitations of administrative databases and the complication screening method, we have demonstrated that having a complication diagnosis is an independent risk factor for death. This study is not the final word on this important topic; these events merit further scrutiny by all those who participate in the care of these complex patients to determine if some of these events are preventable.

Complication diagnoses during congenital heart surgery admissions are associated with a greater than twofold risk for death and occurred in nearly one-third of congenital heart surgery admissions. Although these analyses do not allow determination of a causal relationship between complication and mortality, this relationship is plausible. Future work must explore the specific patient events represented by these diagnosis codes to understand their severity and potential preventability.

	References

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This Article Abstract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Personal Folders Download to citation manager Author home page(s): Emile Bacha Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Benavidez, O. J. Articles by Jenkins, K. J. Search for Related Content PubMed PubMed Citation Articles by Benavidez, O. J. Articles by Jenkins, K. J. Related Collections Congenital - cyanotic Professional affairs Related Article