The first report of the Society of Thoracic Surgeons

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1 REPORT The Society of Thoracic Surgeons National Congenital Heart Surgery Database Report: Analysis of the First Harvest ( ) Constantine Mavroudis, MD, Melanie Gevitz, BA, W. Steves Ring, MD, Charles L. McIntosh, MD, and Marc Schwartz, BS Children s Memorial Hospital, Chicago, Illinois This analysis summarizes the first report of the Society of Thoracic Surgeons National Congenital Heart Surgery Database Committee in association with Summit Medical Systems. Twenty-four centers joined the program at various dates of entry resulting in 18,894 enrolled patient records. This report compiled the relevant clinical features of 18 congenital heart categories over a 4-year period ( ), which included 8,149 patient records. The data analyses are largely descriptive in character. Missing data points were described and not omitted in the analysis. Statistical analysis was not performed due to missing data points in some categories. Certain trends, however, could be identified and are discussed. The first Society of Thoracic Surgeons National Congenital Heart Surgery Database Report has succeeded in establishing a finite record that can be improved to establish universal national and international utility, risk stratification, and scholarly outcome analyses. (Ann Thorac Surg 1999;68:601 24) 1999 by The Society of Thoracic Surgeons The first report of the Society of Thoracic Surgeons (STS) National Congenital Heart Surgery Database Committee in association with Summit Medical Systems was recently published [1]. Twenty-four centers (Appendix 1) joined the program at various dates of entry resulting in 18,894 enrolled patient records. The distribution of all primary diagnosis entries for the 18,894 enrolled patient records is listed in Appendix 2. This report compiled the relevant clinical features of 18 congenital heart categories over a 4-year period ( ), which included 8,149 patient records. Emphasis was placed on the total number of patients for each category, the types of operations that were performed, the methods of myocardial protection, and five specific features of repair. Outcome data included operative death, complications, and length of stay (LOS). Outcome analyses were segregated for age or weight at operation where appropriate, which varied from diagnosis to diagnosis. The data analyses were largely descriptive in character and identified missing data points, which were not entered by some participating centers. Rather than eliminate these patients from the analyses, the nonentries were listed as missing data to allow the reader to assess the relevance and importance of the data. Similar to the STS adult cardiac surgery database, this report of the STS National Congenital Heart Surgery Database generated a massive amount of data. These data depicted many trends and were largely predictive of the established previous clinical reports from different Address reprint requests to Dr Mavroudis, Children s Memorial Hospital, 2300 Children s Plaza, MC22, Chicago, IL 60614; centers. The analysis also demonstrated the strengths and weaknesses of a database, which, by necessity, limited the data input. On one hand, the four-page data form was readily available and concise; on the other hand, the information was limited and did not allow discriminating features that are necessary to establish risk stratification analysis. Unlike the STS adult cardiac surgery database, the Congenital Heart Surgery Database has numerous disease entities to analyze and by nature of the subspecialty, requires increased complexity in data analysis to produce meaningful risk stratification. This inaugural effort of the STS National Congenital Heart Surgery Database Committee established the necessary foundation for future efforts to create an International Congenital Heart Surgery Database. The groundwork was created in areas of data organization for analysis. Important lessons learned from this initial database will shape the development of the next generation database, which will be computer based in cyberspace rather than limited by the size of four sheets of paper. This will allow for the collection of increased data input, the elimination or at least reduction of missing data points, and the generation of data specific enough to possess discriminating features necessary to establish risk stratification analysis. This next generation database will need to meet the dual goals of facilitating multiinstitutional data analysis, as well as providing data to support clinical programs, research, and teaching at individual institutions. The potential exists to create the first comprehensive international database for a medical subspecialty by The Society of Thoracic Surgeons /99/$20.00 Published by Elsevier Science Inc PII S (99)

2 602 REPORT MAVROUDIS ET AL Ann Thorac Surg STS NATIONAL CONGENITAL HEART SURGERY DATABASE REPORT 1999;68: Analysis of Diagnoses Atrial Septal Defect Parameters for inclusion in the atrial septal defect (ASD) subgroup study population were repair of ASD as the primary procedure with a primary diagnostic field of a specific subtype of ASD. Records with other concomitant diagnoses were excluded from the study population except for those with associated left superior vena cava. The distribution of isolated ASD by type in the STS study population reflects that described by other researchers [2]. More than 1,500 patients were reported; 90.7% secundum, 7.3% sinus venosus, 0.8% common atrium, and 1% residual type. Approximately 4 in 5 patients (81.8%; 1,132 of 1,384) with secundum ASD underwent operation with preoperative echocardiographic study only; 13% had preoperative echocardiographic and catheterization studies, and 1.7% had preoperative catheterization only; data were missing on 43 patients (3.1%). Similarly, approximately 3 of 4 patients (77%; 88 of 114) with sinus venosus ASD underwent operation with preoperative echocardiographic study only and 20% (23 of 114) had preoperative echocardiographic and catheterization studies; data were missing on 3 patients (2.6%). Although the number of patients with common atrium or residual ASD is small (28 patients), here too, 83% and 50% of the total common atrium and residual ASD patients, respectively, underwent operation with preoperative echocardiographic study only. This preference for echocardiography as the primary preoperative diagnostic tool was constant throughout the 4-year study period ( ). Median age at repair of all types of ASDs was 5.1 years; 25th and 75th percentiles were 3.0 and 11.5 years, respectively. Female-to-male ratio in the total ASD study population was 1.6:1. The ratio was 2:1 in the common atrium subgroup, 1.7:1 in both the secundum and residual subgroups, and 1.1:1 in the sinus venosus subgroup. Cardiopulmonary bypass (CPB) was used for repair of ASD. As a measure of data validity, only 4.3% (66 of 1,526 patients) of ASD records had missing CPB data (time of CPB run). Further analysis of those records with CPB data revealed 68.4% (999 of 1,460 patients) used crossclamping of the aorta, whereas 20.8% (303 of 1,460 patients) used induced fibrillation; 10.8% (158 of 1,460 patients) of the records were missing data on the specific technique used. Of the 999 patient records with crossclamp times specified for the 4-year study period, blood cardioplegia was used in 54.2% (541 of 999 patients), crystalloid cardioplegia in 30.5% (305 of 999), and other cardioplegia in 5.7% (57 of 999 patients); data were missing in 9.6% (96 of 999) of the records. Closure of the ASD was by suture in 52.0% (794 of 1,526 patients) or by patch in 44.6% (681 of 1,526 patients); data fields were not completed in 51 (3.3%) records. The complication incidence in isolated ASD closure is low. Of the 1,526 records in the study period, 1,425 (93.4%) reported no complications. There was only 1 operative death (death within hospitalization or within 30 days of surgical procedure) for a mortality rate of 0.07%. Of note, this death was in a patient with residual ASD diagnosis. Slightly 1% of patients (15 of 1,526 patients) underwent reoperation for bleeding, valve dysfunction, residual defect, other cardiac or noncardiac problems, and/or sternal closure. Complications attributable to infection occurred in 10 patients (0.66%). Other major system complications were reported in a small number of patients: 2 major neurologic complications (0.13%), 9 pulmonary complications (0.59%), and 1 renal complication (0.07%). Eighty-three patients (5.44%) had complications other than those specifically mentioned. The trend toward increasing use of same-day operation in the pediatric population was reflected by the STS data. From 1994 to 1997 the percentage of same-day operation patients increased from 54.3% in 1994 to 74.1% in 1995, 77.8% in 1996, and 79.9% in As a caveat, however, records with incomplete data were excluded; thus, 33% (507 of 1,526 patients) of the ASD study population records were not included in this analysis. The data available on preoperative LOS, however, support the trend toward same-day operation; here, missing dates account for a loss of only 99 of 1,526 records (6.5%). Postoperative LOS data remained relatively constant over the study period. Mean postoperative LOS was 3.7 days and was 3.7, 3.4, 4.0, and 3.5 days in 1994 through 1997, respectively. Although the subgroup s numbers are small, the LOS of patients with the residual ASD was 1 day longer on average. Ventricular Septal Defect Parameters for inclusion in the ventricular septal defect (VSD) subgroup study population were repair of VSD as the primary procedure with a primary diagnostic field of a specific subtype of VSD. Records with other concomitant diagnoses were excluded from the study population except for those with associated ASD, patent ductus arteriosus, or left superior vena cava. The distribution of isolated VSD by type in the STS study population reflects that described by other researchers [3]. In the 4-year study period, almost 1,200 patients were reported; 78.2% perimembranous, 8.8% conal, 5.6% muscular, 3.4% inlet (atrioventricular canal type), 3.1% multiple, and 0.9% residual type. More than one-half of the patients (52.2%; 477 of 914) with perimembranous VSD underwent operation with preoperative echocardiographic study only; 42.5% had preoperative echocardiographic and catheterization studies, and 1.7% had preoperative catheterization only; data were missing on 33 patients (3.6%). Although the number of patients reported was much smaller, it is of interest that patients with conal and inlet type VSDs were more likely to have only preoperative echocardiographic diagnostic studies, 62.1% (64 of 103 patients) and 57.5% (23 of 40 patients), respectively. For these two subgroups, 35% of the conal patients and 40% of the inlet patients had both preoperative echocardiographic and catheterization studies. One patient in the conal subgroup had a preoperative catheterization only; in the inlet subgroup, no patient had catheterization only. In the multiple, muscular, and residual subgroups, fewer patients underwent only preop-

3 Ann Thorac Surg REPORT MAVROUDIS ET AL 1999;68: STS NATIONAL CONGENITAL HEART SURGERY DATABASE REPORT 603 erative echocardiographic study; 41.7% (15 of 36 patients) in the multiple subgroup, 35.4% (23 of 65) in the muscular subgroup, and 20% (2 of 10 patients) in the residual subgroup. Concomitantly, the percentage of patients in these groups who underwent both echocardiographic and catheterization studies preoperatively was higher; 52.8% (19 of 36 patients) in the multiple subgroup, 58.5% (38 of 65) in the muscular subgroup, and 80% (8 of 10 patients) in the residual subgroup. Of note, in % (129 of 299 patients) had preoperative echocardiographic diagnostic study only. This increased to 53.1% (163 of 307) in 1995, 51.3% (160 of 312) in 1996, and finally, 60.8% (152 of 250 patients) in Concomitantly, preoperative echocardiographic and catheterization studies decreased from a high in 1994 of 49.5% (148 of 299 patients) to a low of 37.2% (93 of 250 patients) in The small number of patients over the study period who had preoperative catheterization study only makes trend analysis impossible. Median age at repair of all types of VSDs was 0.69 years ( 8 months); 25th and 75th percentiles were 0.37 years ( 4 months) and 2.5 years, respectively. The female-tomale ratio in the total VSD study population and the perimembranous subgroup was 1:1. Men predominated in only one subgroup, the conal, where the male-tofemale ratio was 1.5:1. Women predominated in the muscular, inlet, multiple, and residual subgroups, where the female-to-male ratio was 1.2:1, 1.9:1, 2:1, and 1.5:1, respectively. Pulmonary artery band (PAB) placed at a previous operation was noted in 51 of the 1,168 records (4.4%). Within this group, 33.3% (12 of 36) were placed in patients with multiple VSDs, 24.6% (16 of 65) were placed in those with muscular VSDs, and 2.2% (20 of 914) were placed in patients with perimembranous defects. Only 1 patient (of 103; 1%) had a previous PAB placement in the conal VSD subgroup, and 2 patients (of 40; 5%) had band placement in the inlet VSD subgroup. The infrequent use of PAB is in keeping with other reports [4]. Cardiopulmonary bypass was used for repair of VSD. As a measure of data validity, only 8.9% (104 of 1,168) of VSD records had missing CPB data (time of CPB run). Further analysis of those records with CPB data revealed 99.1% (1,054 of 1,168) used cross-clamping of the aorta, whereas 0.2% (2 of 1,168) used induced fibrillation; 0.8% (8 of 1,168) of the records were missing data on the specific technique used. Of the 1,064 patients with known CPB status, 142 (13.35%) had circulatory arrest. The percentage, in descending order, of circulatory arrest utilization per defect subgroup was 27.3% (6 of 27) in those patients with multiple VSDs, 20.8% (11 of 53) in those with muscular VSDs, 18.9% (7 of 37) in those with inlet type VSDs, 13.1% (111 of 844) in those with perimembranous defects, 11.1% (1 of 9) in those with residual defects, and 6.1% (6 of 99) in those with conal defects. Of note, the reported use of circulatory arrest declined over the 4-year study period, from a high of 53 patients (19.6%) reported in 1994, 41 (15.0%) in 1995, 34 (12.0%) in 1996, to a low of 14 patients (6.0%) in Whether this is a declining trend in use of circulatory arrest or reflects declining reporting on the part of users is subject to speculation. The percentage of use of circulatory arrest within two age groups ( 6 months of age/ 6 months of age) remains consistent over time, even with the decreasing number of patients reported, suggesting that this is a trend versus an artifact of missed reported cases. In 1994, 34 of 53 patients (64.1%) reported were 6 months of age; in 1997, 9 of 14 patients reported (64.3%) were 6 months of age; however, there was a drop in 1995 and 1996 to 58.5% and 55.9%, respectively, in patients reported 6 months of age. The subgroup of patients having circulatory arrest during VSD repair was further analyzed according to age at repair. Those 6 months of age represented 60.6% (86 of 142) of all patients having circulatory arrest. The percentage for each subgroup, in decreasing order, within those patients 6 months of age having circulatory arrest is, 85.7% (6 of 7 patients) with inlet-type VSDs, 83.3% (5 of 6) with conal VSD, 81.8% (9 of 11) with muscular VSD, 58.6% (65 of 111) with perimembranous VSD, and 16.7% (1 of 6 patients) with multiple VSDs. In the 56 patients 6 months of age, 83.3% (5 of 6) had multiple VSDs, 41.4% (46 of 111) had perimembranous defects, and 18.2% (2 of 11) had muscular VSDs. There was 1 patient each in three of the subgroups, inlet, conal, and residual, representing 14.3%, 16.7%, and 100%, respectively, of the VSD population 6 months of age having circulatory arrest. Of the 1,054 patient records with cross-clamp times specified for the 4-year study period, blood cardioplegia was used in 62% (653 patients), crystalloid cardioplegia in 21.8% (230), and other cardioplegia in 7.3% (77 patients); data were missing in 8.9% (94) of the records. Closure of the VSD was by suture in 4.0% (47 of 1,168 patients) or by patch in 85.4% (998 of 1,168 patients); data fields were not completed in 123 records (10.5%). Patches were placed either transatrial (899 of 998, 90.1%), transpulmonary artery (55 of 998, 5.5%), transventricular (right or left) (42 of 998, 4.2%), or transaorta (2 of 998, 0.2%). The complication incidence in isolated VSD closure is low. Of the 1,168 records in the study period, 1,001 (85.7%) reported no complications. There were 11 operative deaths (death within hospitalization or within 30 days of surgical procedure) for a mortality rate of 0.9%. Only two VSD subgroups had rates 1%: multiple VSDs (3 of 36, 8.3%) and muscular VSDs (1 of 65, 1.5%). Slightly more than 3% (37 of 1,168) of patients underwent reoperation for bleeding, valve dysfunction, residual defect, other cardiac or noncardiac problems, and/or sternal closure. Complications attributable to infection occurred in 19 patients (1.6%). Other major system complications were reported in a small number of patients: 4 major neurologic complications (0.3%), 50 pulmonary complications (4.3%), and 3 renal complications (0.3%). In addition to or other than those major system or operative complications specifically mentioned, 122 patient records (10.4%) were marked as having other complications. When the complication incidence is further analyzed by age, those 6 months of age represent 36.3% of the population (424 of 1,168 patients). Of these, only 337 of the 1,001 (33.7%) reported no complications. Operative

4 604 REPORT MAVROUDIS ET AL Ann Thorac Surg STS NATIONAL CONGENITAL HEART SURGERY DATABASE REPORT 1999;68: mortality was 1.65% in this subgroup (7 of 424) versus 0.5% (4 of 744) in those 6 months of age. Rather than reporting absolute percentages within the 6 months of age cohort, the proportion of complications in this age group relative to the entire VSD population reveals the impact that early age at repair has on incidence of complications. Within every category of complications analyzed (with the exception of renal complications), the 6 months of age subgroup had incidences ranging from 50% to 70% of the complications noted for VSD repair for all ages. Seven of the total number of VSD operative deaths (of 11, 63.6%) were in this age group. Twenty of 37 patients (54%) were 6 months of age and underwent reoperation for bleeding, valve dysfunction, residual defect, other cardiac or noncardiac problems, and/or sternal closure. Ten of 19 patients (52.6%) were 6 months of age and had complications attributable to infection. Other major system complications were reported in a small number of patients: 2 major neurologic complications (of 4 patients, 50%), 35 pulmonary complications (of 50, 70%) and 1 renal complication (of 3, 30%). In addition to or other than those major system or operative complications specifically mentioned, 62 patient records (of 122, 50%) were marked as having other complications. The trend toward increasing use of same-day operation in the pediatric population was reflected by the STS data. From 1994 to 1997 the percentage of same-day operation patients increased from 43.5% in 1994 to 58.4% in 1995, 69.7% in 1996, and 69.5% in As a caveat, however, records with incomplete data were excluded; thus, 44.3% (518 of 1,168) of the VSD study population records were not included in this analysis. On the basis of 1,082 reports of same-day admission and operation, when further broken down into age subcategories, 158 of 384 patients were 6 months of age (41.2%) and were reported to be admitted for same-day operation, versus 492 of 698 patients 6 months of age (70.5%). The data available on preoperative LOS, however, support the trend toward same-day operation; here, missing dates account for a loss of only 86 of 1,168 records (7.4%). When the data are further analyzed by age less or more than 6 months of age, for the 4-year study period, the mean preoperative LOS for patients 6 months of age was 6.8 days versus 0.9 days for patients 6 months of age. These younger patients are, by implication, admitted, presumably, for medical stabilization; their higher morbidity is reflected in their higher incidence of postoperative complications as discussed. It is beyond the scope of the database to comment on whether the higher incidence of complications may have had their root in preoperative morbid states or was truly secondary to the surgical repair. Postoperative LOS data remained relatively constant over the study period. Mean postoperative LOS was 7.2 days and was 8.4, 6.6, 6.9, and 6.9 days in 1994 through 1997, respectively. Although some of the patient numbers of the subgroups are small, the mean postoperative LOS ranged from 5.2 days for the conal VSD subgroup (n 98), to 9.6 days for the muscular VSD subgroup (n 59). The mean postoperative LOS of inlet VSD patients was 6.7 days (n 37), and was 7.2, 8.3, and 9.1 days for the perimembranous (n 838), multiple (n 30), and residual (n 10) subgroups, respectively. The age of the patient at VSD repair had a profound impact on the postoperative LOS. For the 4-year study period, of 694 patients 6 months of age, the mean postoperative LOS was 4.9 days; for those 6 months of age, it was 11.4 days, more than double. These data are largely confirmatory of recent publications on the subject [5, 6] and demonstrate the power of such a database when standards can assure purity of data input and retrieval. Atrioventricular Canal Parameters for inclusion in the atrioventricular canal (AVC) subgroup study population were repair of AVC or ASD primum (with or without cleft mitral valve) as the primary procedure with a primary diagnostic field of a specific subtype of AVC or ASD primum. Records with other concomitant diagnoses were excluded from the study population except for those with associated ASD, patent ductus arteriosus, or left superior vena cava. In the 4-year study period, 590 patients were reported in the AVC defects group, 53.7% (317 of 590 patients) complete AVC, 36.6% (216 of 590) ASD primum, and 9.7% (57 of 590) intermediate AVC. One-half of the patients (50.5%, 160 of 317) with complete AVC underwent operation with preoperative echocardiographic study only; 43.8% (139 of 317) had preoperative echocardiographic and catheterization studies, and 1.3% (4 of 317) had preoperative catheterization only; data were missing on 14 patients (4.4%). Of the patients with ASD primum and intermediate AVC, 63.9% (138 of 216) and 54.4% (31 of 57), respectively, underwent operation with preoperative echocardiographic study only; 33.8% (73 of 216 patients) and 36.8% (21 of 57 patients), respectively, had preoperative echocardiographic and catheterization studies, and 2% (2 of 216 patients) and 3.5% (2 of 57 patients), respectively, had preoperative catheterization only; data were missing on 3 patients in each group (1.4% and 5.3%, respectively). Of note, the trend for preoperative echocardiographic study only in the ASD primum subgroup is strong, with the ratio of preoperative echocardiographic study only-to-echocardiogram catheterization increasing from 1.1:1 in 1994, to 2.2:1 in 1995, to 1.9 in 1996, and finally, to 3:1 in Median age at repair of all types of AVCs for the 4-year study period was 0.56 years (between 6 and 7 months); 25th and 75th percentiles were 0.37 years ( 4 months) and 1.5 years, respectively. Female-to-male ratio in the total AVC study population was 1.3:1; in the complete AVC subgroup, 1.1:1; in the ASD primum subgroup, 1.7:1; and in the intermediate AVC subgroup, 1:1. Pulmonary artery band placed at a previous operation was noted in 10 of the 590 records (1.7%). Within this group, 7 were placed in patients with complete AVCs, and 3 were placed in patients with primum ASD. This is in keeping with the reports of other researchers, with primary repair the procedure of choice in the infant with AVC defect [7].

5 Ann Thorac Surg REPORT MAVROUDIS ET AL 1999;68: STS NATIONAL CONGENITAL HEART SURGERY DATABASE REPORT 605 Cardiopulmonary bypass (CPB) was used for repair of AVC. As a measure of data validity, only 6.1% (36 of 590) of AVC records had missing CPB data (time of CPB run). Further analysis of those records with CPB data revealed 99.1% (549 of 554 patients) used cross-clamping of the aorta, whereas 0.2% (1 of 554) used induced fibrillation; 0.7% (4 of 554) of the records were missing data on the specific technique used. Of the 549 patient records with cross-clamp times specified for the 4-year study period, blood cardioplegia was used in 69.2% (380 of 549 patients), crystalloid cardioplegia in 15.9% (87 of 549), and other cardioplegia in 8.2% (45 of 549); data were missing in 6.7% (37 of 549) of the records. Closure of complete AVC defect was by single-patch technique in 39.4% (125 of 317 patients) or with use of double patch in 56.2% (178 of 317 patients); data fields were not completed in 14 records (4.4%). Closure of intermediate AVC defect was by single-patch technique in 86% (49 of 57) or with use of double patch in 8.8% (5 of 57); data fields were not completed in 3 records (5.3%). Closure of ASD primum defect was by singlepatch technique in 76% (164 of 216 patients); data fields were not completed in 52 records (24.7%). Double patch technique is inappropriate for ASD primum repair. We found it encouraging that double patch technique did not get recorded in the analysis. Of the 590 AVC defect records in the study period, 459 (77.8%) reported no complications. There were 17 operative deaths (death within hospitalization or within 30 days of surgical procedure) for a mortality rate of 2.9% for the 4-year study period. Fourteen of the 17 deaths (82.4%) occurred in the complete AVC subgroup for a mortality rate of 4.4% (14 of 317 patients), 1 in the intermediate AVC subgroup for a mortality rate of 1.8% (of 57), and 2 in the ASD primum subgroup for a mortality rate of 0.9% (of 216). Other specific complications and their incidence will be discussed in terms of each defect, not for the group as a whole. In addition, within each of the three subgroups (complete AVC, intermediate AVC, primum ASD), data were analyzed for the impact of patient age ( 6 months versus 6 months) at the time of operation on outcome. In the complete AVC subgroup, in patients 6 months of age, no complications were recorded for 63.6% (133 of 209) of the patients; in those 6 months of age, no complications were recorded for 81.5% (88 of 108). There were 11 operative deaths in the 6 months of age complete AVC subgroup (11 of 209, 5.3%); in those 6 months of age, 3 deaths occurred (3 of 108, 2.8%). Almost 7% (14 of 209, 6.7%) of patients 6 months of age underwent reoperation for bleeding, valve dysfunction, residual defect, other cardiac or noncardiac problems, and/or sternal closure; in those 6 months, 8 of 108 (7.4%) underwent reoperation. Complications attributable to infection occurred in 9 patients 6 months of age (9 of 209 patients, 4.3%); in those 6 months of age, the incidence was 2.8% (3 of 108 patients). Other major system complications were also reported. There were two major neurologic complications in the 6 months population segment (of 209, 1.0%), none in those 6 months of age. Almost 40 patients in the 6 months population segment had pulmonary complications (38 of 209, 18.2%); in those 6 months of age, the incidence was 7.4% (8 of 108). Renal complications were noted in 3 of 209 (1.4%) patients in the 6 months of age population segment, none in those 6 months of age. In addition to or other than those major system or operative complications specifically mentioned, 57 patient records (of 209, 27.3%) were marked as having other complications in the 6 months of age segment; only 13 of 108 (12%) records were so marked in those 6 months of age. In the intermediate AVC subgroup, in patients 6 months of age, no complications were recorded for 75% (15 of 20) of the patients. In those 6 months of age, no complications were recorded for 78.4% (29 of 37 patients); the only area where complications were noted in this age group was in other complications (discussed later). There was one operative death in the 6 months of age intermediate AVC subgroup (of 20, 5%). Five percent (1 of 20) of patients 6 months of age underwent reoperation for bleeding, valve dysfunction, residual defect, other cardiac or noncardiac problems, and/or sternal closure. Complications attributable to infection occurred in 2 patients 6 months of age (of 20, 10%); there were no major neurologic complications, 2 of 20 (10%) had pulmonary complications, and 1 of 20 (5%) had renal complications. In addition to or other than those major system or operative complications specifically mentioned, 5 patient records (of 20, 25%) were marked as having other complications in the 6 months of age segment; 8 of 37 (21.6%) records were so marked in those 6 months of age. In the primum ASD subgroup, in patients 6 months of age, no complications were recorded for 70.4% (19 of 27) of the patients; in those 6 months of age, no complications were recorded for 92.6% (175 of 189). There were two operative deaths in the 6 months of age primum ASD subgroup (of 27, 7.4%); in those 6 months of age, no deaths were reported. Eleven percent (3 of 27, 11.1%) of patients 6 months of age underwent reoperation for bleeding, valve dysfunction, residual defect, other cardiac or noncardiac problems, and/or sternal closure; in those 6 months, 2 of 189 (1.1%) underwent reoperation. Complications attributable to infection occurred in 2 patients 6 months of age (of 189, 1.1%). Other major system complications were also reported. There was one major neurologic complication in the 6 months population segment (of 27, 3.7%), two in those 6 months of age (of 189, 1.1%). Four patients in the 6-month population segment had pulmonary complications (of 27, 14.8%); in those 6 months of age, the incidence was 1.6% (3 of 189 patients). There were no renal complications noted in either age group. In addition to or other than those major system or operative complications specifically mentioned, 7 patient records (of 27, 25.9%) were marked as having other complications in the 6 months of age segment; 11 of 189 (5.8%) records were so marked in those 6 months of age. In all three diagnostic subgroups, patients 6 months of age were at higher risk for mortality and morbidity.

6 606 REPORT MAVROUDIS ET AL Ann Thorac Surg STS NATIONAL CONGENITAL HEART SURGERY DATABASE REPORT 1999;68: The trend toward increasing use of same-day operation in the pediatric population was reflected by the STS data. From 1994 to 1997, 308 patient records indicated planned same-day surgical admission; the percentage of same-day operation patients increased from 40% in 1994 to 59.2% in 1995, 62.7% in 1996, and 64.2% in 1997 (percentages based on 545 records with admission and surgical date fields completed). Thus, 47.8% (282 of 590 patients) of the AVC defect study population records were not included in this analysis. When further broken down into age categories, 107 of 308 patients 6 months of age (45.5%) were reported to be admitted for same-day operation versus 201 of 308 patients 6 months of age (64.8%). The data available on preoperative LOS, however, support the trend toward same-day operation; here, missing dates account for a loss of only 45 of 590 records (7.6%). The 50th percentile figures from 1994 to 1997 were 1 day, 1 day, 0 day, and 0 day, respectively, for the 6-month age group; for the 6-month age group, they were 1 day, 0 day, 0 day, 0 day. When the data are further analyzed by age less or more than 6 months of age, for the 4-year study period, the mean preoperative LOS for patients 6 months of age was 5.0 days, versus 1.6 days for patients 6 months of age. These younger patients are, by implication, admitted, presumably, for medical stabilization; their higher morbidity is reflected in their higher incidence of postoperative complications as discussed. It is beyond the scope of the database to comment on whether the higher incidence of complications may have had their root in preoperative morbid states or were truly secondary to the surgical repair. When the data are analyzed by defect subgroup, the mean preoperative LOS over the 4-year study period for the complete AVC subgroup for whom admission dates were available was 4.3 days, for the intermediate AVC subgroup mean preoperative LOS was 1.3 days, and for the ASD primum subgroup it was 1.7 days. Postoperative LOS data remained relatively constant over the study period. Mean postoperative LOS for the AVC defect population was 9.7 days and was 11.4, 8.4, 9.8, and 9.6 days in 1994 through 1997, respectively. The mean postoperative LOS ranged from 6 days for the ASD primum subgroup (n 198), to 7.9 days for the intermediate AVC subgroup (n 55), to 12.7 days for the complete AVC subgroup (n 278). The age of the patient at AVC repair had a profound impact on the postoperative LOS. For the 4-year study period, of 309 AVC defect population patients 6 months of age, the mean postoperative LOS was 6.6 days; for those 6 months of age, it was 14 days, more than double. Within the defect subgroups, those 6 months of age with ASD primum had a mean postoperative LOS of 11 days; those 6 months of age, 5.3 days. Those 6 months of age with intermediate AVC had a mean postoperative LOS of 11.8 days; those 6 months of age, 5.8 days. Those 6 months of age with complete AVC had a mean postoperative LOS of 14.6 days; those 6 months of age, 9.3 days. These data are reflective of some of the more favorable reports in the literature concerning outcome after repair of AVC [7, 8]. The less or more than 6-month of age data are interesting and should help to establish future risk stratification criteria and cost projections. Truncus Arteriosus Inclusion criteria were primary diagnosis of truncus arteriosus (truncus), with indicated subtype. Allowable concomitant diagnoses included ASD, patent ductus arteriosus (PDA), significant truncal insufficiency, and left superior vena cava. The distribution of the Van Praagh and Van Praagh [9] class subtypes was similar to recent reports [10, 11]. Of the 193 reported cases ( ), 63.7% (123 of 193 patients) were class A1, 23.8% (46 of 193) were class A2, 6.8% (13 of 193) were class A3, and 5.7% (11 of 193 patients) were class A4. Significant truncal insufficiency according to class was present in 14 patients (11.4%), 2 (4.3%), 3 (23.1%), and 1 patient (9.1%), respectively. The principal methods of preoperative diagnosis underwent a change over the study period indicating a greater reliance on echocardiography. The percentages of patients who had echocardiography, without cardiac catheterization over the study period were 29.5% in 1994, 32.7% in 1995, 47.5% in 1996, and 52.6% in Conversely, the percentage of patients undergoing catheterization and echocardiography decreases over the study period, 56.8%, 53.9%, 47.5%, and 44.7%, respectively. The number of patients who had only a catheterization study was small (2.1%); the number of missing entries for method of diagnosis was 13 (6.7%). Median age at repair for all patients was 1 month; 25th and 75th percentiles were 2 weeks and 5.5 months, respectively. The female-to-male ratio for all patient types was 1.2:1. Cardiopulmonary bypass was used for repair of truncus. As a measure of data validity, 10.9% (21 of 193) of truncus records had missing CPB data (time and CPB run). Further analysis of those records with CPB data showed that 90.1% (155 of 172) used aortic cross-clamping and 1.2% (2 of 172) used induced fibrillation; 8.7% (15 of 172) of the records were missing data on the specific technique used. Of the 155 patient records with crossclamp times specified for the 4-year study period, blood cardioplegia was used in 63.2% (98 of 155 patients), crystalloid cardioplegia was used in 17.4% (27 of 155), other types of cardioplegia were used in 13.6% (21 of 155), and missing entries comprised 5.8% (9 of 155 patients). The data involving the features and repair were disappointing. The standard repair for truncus involves a valved right ventricular to pulmonary artery conduit. Only 52.9% (102 of 193 patients) had recorded conduit data. Interestingly, 100% of the 102 patient records that included conduit data subgrouped the conduits into homograft types (98 of 102) or bioprosthetic (non-human) types (4 of 102). The complication rate for truncus repair is relatively high. Of the 193 records during the study period, 121 (62.7%) reported no complications. There were 22 operative deaths (11.4%), 4 of whom had severe truncal insufficiency (death within hospitalization or within 30

7 Ann Thorac Surg REPORT MAVROUDIS ET AL 1999;68: STS NATIONAL CONGENITAL HEART SURGERY DATABASE REPORT 607 days of surgical procedure). More than 16% (31 of 193 patients) underwent reoperation for bleeding, valve dysfunction, residual defect, other cardiac or noncardiac problems, and/or sternal closure. Complications due to infection occurred in 6 patients (3.1%), to pulmonary problems in 29 (15.0%), and to other conditions not otherwise specified in 51 patient records (26.4%). Operative mortality for truncus was further analyzed by age at operation, which included: 1 month of age, 1 3 months of age, and 3 months of age. The percentage mortality was 14.6% (14 of 96 patients), 17.1% (7 of 41), and 1.8% (1 of 56 patients), respectively. It would seem from these data that patients do better when the operation is performed after 3 months of age. These data, however, do not reflect the inherent mortality during the waiting period before the operation is performed. As expected, the mortality for type A1 truncus (8.1%) is about 50% less than the mortality for types A2, A3, and A4, which were 15.2%, 23.1%, and 18.2%, respectively. These expected findings reflect the greater hemodynamic problems associated with the most complex pathoanatomy. Postoperative LOS data reflected the complexity and severity of the disease. Mean postoperative LOS for all truncus patients for the 4-year study period was 17.6 days (25th and 75th percentiles were 7 and 20 days, respectively), and was 13.6, 17.0, 18.0, and 22.3 days in 1994 through 1997, respectively. When separated into subgroups by age, the average LOS for 1 month of age, 1 3 months of age, and 3 months of age were 20.9, 20.9, and 10.8 days, respectively. These trends reflect recent clinical reviews [10, 11]. Aortopulmonary Window Inclusion criteria for aortopulmonary window (AP window) were primary diagnosis of AP window (all types). Allowable concomitant diagnoses were ASD, VSD, PDA, and left superior vena cava. The number of enrolled patient records over the 4-year study period ( ) was small (14 patients) and reflected on the rarity of the disease [12]. Diagnosis was by echocardiography only in 71.4% (10 of 14), cardiac catheterization only in 0%, and by both cardiac catheterization and echocardiography in 7.1% (1 of 14 patients). There were 3 (21.4%) missing data points. Female-to-male ratio was 1:1. Features of repair reflected mainstream techniques. The use of CPB (time of CPB run) was recorded in 12 of 14 patients (85.7%) and therefore, either missing or not used in 2 patients (14.3%). Missing data also confounded the use of cross-clamp in 9 of 12 patients (75.0%) and cardioplegia (blood cardioplegia in 6 and crystalloid cardioplegia in 2 patients), which was recorded in 8 of 9 patients (88.9%) whose records indicated that aortic cross-clamping was used. Operative mortality (death within hospitalization or within 30 days of surgical procedure) over the 4-year study period ( ) was zero (0%), whereas 71.4% (10 of 14) of patient records recorded no complications. Postoperative LOS was recorded in 13 of 14 patients and was a mean of 9.9 days, 25th and 75th percentiles 5 and 7 days, respectively. The small number of recorded cases and paucity of relevant data acquisition made this analysis difficult and almost irrelevant. For instance, because of the small numbers, we did not segregate those patients who had associated VSD. We could not examine the clinical outcomes in relation to the different types of AP window and to the various coronary artery anomalies because there were no designated categories on the database. Interestingly, we decided against too much detail in low volume diagnoses such as these when the database was being established. In light of these results with AP window, one could argue that more data rather than less data, especially in the low volume diagnoses, are indicated to more effectively analyze these relatively rare cases. Anomalous Origin of Coronary Artery From the Pulmonary Artery Parameters for inclusion in the anomalous origin of coronary artery from the pulmonary artery (ACAPA) study group population were primary diagnosis of ACAPA. Records with other concomitant diagnoses were excluded from the study population except for those with associated ASD, PDA, mitral regurgitation, or left superior vena cava. The number of patients with ACAPA was surprisingly low based on the number of participating centers and enrolled patients. Forty-six patient records were identified over the 4-year study period; 44 had anomalous left main coronary artery arising from the pulmonary artery (ALCAPA) and 2 had anomalous right coronary artery arising from the pulmonary artery (AR- CAPA). No trends were noted over time in the method of diagnosis. The principal method of diagnosis was by echocardiography alone in 36% (16 of 46 patients), by cardiac catheterization alone in 2.2% (1 of 46), and by echocardiography and cardiac catheterization in 58.7% (27 of 46 patients); missing data for diagnosis occurred in 2 patients (4.4%). Recent publications [13, 14] have extolled the benefits and feasibility of echocardiographyonly diagnosis, which was not noted in this study. The average age at operation for ALCAPA during the 4-year period was 4.5 months (25th and 75th percentiles were 2.5 and 9.5 months, respectively). The female-to-male ratio for ACAPA was 3.2:1. The number of patients having same-day operation over the study period was small (8 of 46 patients) (20.5%). Cardiopulmonary bypass was used for repair of ACAPA. As a measure of data validity, 6.5% (3 of 46 ACAPA records) had missing CPB data (time of CPB run). Further analysis of these records with CPB data revealed 100% (43 of 43) used cross-clamping of the aorta for the repair. No patient record showed the use of induced fibrillation and there were no missing methods. Of the 43 patient records with cross-clamp times specified for the 4-year period, blood cardioplegia was used in 69.8% (30 of 43 patients), crystalloid cardioplegia in 20.9% (9 of 43), and other cardioplegia in 7.0% (3 of 43 patients). There was only one missing method. Because the operative repair for ACAPA involves procedures on the coronary arteries, an analysis on cardioplegia delivery (antegrade versus retrograde) was made. Antegrade, retrograde, and both antegrade as well as retrograde car-

8 608 REPORT MAVROUDIS ET AL Ann Thorac Surg STS NATIONAL CONGENITAL HEART SURGERY DATABASE REPORT 1999;68: dioplegia was used in 60.5% (26 of 43), 4.7% (2 of 43), and 27.9% (12 of 43 patient records), respectively. Cardioplegia delivery method was missing in 6.9% (3 of 43). This database did not provide a comprehensive list of treatment options for ACAPA such as ligation, Takuchi operation, reimplantation, internal thoracic artery coronary bypass, or subclavian to coronary anastomosis. The choices for the features of ACAPA repair in this database were ligation, reimplantation/coronary artery bypass grafting, and concomitant extracorporeal membrane oxygenation. Reimplantation/coronary artery bypass grafting, which includes all methods of coronary bypass and reimplantation, was used in the greater majority of patients (89.1%, 41 of 46 patients), with simple ligation used in 4.4% (2 of 46). Missing methods occurred in 6.5% (3 of 46 patients). Concomitant extracorporeal membrane oxygenation was used in 6.5% (3 of 46 patient records) as a method of perioperative left ventricular support. The complication incidence in ACAPA reflected the problems associated with left ventricular dysfunction, which is so prevalent in this patient population. Of the 46 patient records in the study period, 28 (60.9%) reported no complications. There were five operative deaths (death within hospitalization or within 30 days of surgical procedure) for a mortality of 10.9% for the 4-year study period. About 13% (6 of 46 patients) underwent reoperation for bleeding, valve dysfunction, residual defect, other cardiac or noncardiac problems, and/or sternal closure. Associated major postoperative complications occurred in a relatively large percentage of patients over the study period: infection 10.9% (5 of 46 patients), pulmonary 23.9% (11 of 46), renal 2.2% (1 of 46), and other 30.4% (14 of 46 patients). When the complication incidence is further analyzed by age, those 1 year of age (37 of 46 patients) had all the mortality (5 deaths, 13.5%), whereas those 1 year of age (9 of 46) had no mortality. These data are expected and reflect the difference in the collateral coronary circulation that inexplicably develops in some patients providing adequate myocardial perfusion and fails to develop in others resulting in poor myocardial perfusion, ventricular dysfunction, and mitral regurgitation. Some investigators [15] have conveniently labeled the adequate collateral group as the adult type and the poor collateral group as the infantile type, which of course explains these data. In any case, this type of nomenclature becomes moot in light of newer and more effective diagnostic studies that identify most patients in infancy, thereby making the diagnostic dilemma irrelevant as early operation is recommended in virtually all patients. Postoperative LOS data remained relatively long and constant over the study period. Mean postoperative LOS was 19.3 days (25th and 75th percentiles, 5 and 19 days, respectively) and was 18.3, 20.5, 11.8 and 22.0, respectively over the 4-year study period ( ). When LOS data were segregated for age the mean LOS for patients 1 year of age was 23.2 days; the mean LOS for patients 1 year of age was 5.6 days. The number of patients in this group was small. In addition, the limited scope of the input data sheet did not allow therapeutic segregation into the various types of revascularization strategies. Those debating future database schemes will have to consider these issues. Coarctation of the Aorta Parameters for inclusion in the coarctation of the aorta (CoA) subgroup study population were repair of CoA as the primary procedure with a primary diagnosis of CoA (all types). Records with other concomitant diagnoses were excluded from the study population except for those with associated PDA or left superior vena cava. The distribution of isolated CoA over the study period showed a decline in numbers reported from a high of 168 patients in 1994 to 132 patients in This most likely reflects the increase over this same time period in the use of catheter dilation of CoA. Of the 591 patients reported, 28.4% (168 patients) were in 1994, 28.3% (167) in 1995, 21% (124) in 1996, and 22.3% (132 patients) in The CoA population was split into three age groups for some analyses: those patients 1 month of age, those 1 month to 1 year of age, and those 1 year of age at the time of surgical repair. There were 32.7% (193 patients) 1 month, 24.2% (143) 1 month to 1 year, and 43.1% (255 patients) 1 year of age at operation. Approximately 71% of CoA patients (421 of 591, 71.2%) underwent operation with preoperative echocardiographic study only; 19.6% (116 of 591) had preoperative echocardiographic and catheterization studies, and 1.4% had preoperative catheterization only. Data were missing on 46 patients (7.8%). This preference for echocardiography as the primary preoperative diagnostic tool was constant (range was 73.2% in 1994 to 69.7% in 1997) throughout the 4-year study period ( ). Median age at repair of CoA was 0.39 years (between 4 and 5 months of age); 25th and 75th percentiles were 0.04 (2 weeks) and 5.4 years, respectively. Female-to-male ratio in the total CoA study population was 1:1.8. Cardiopulmonary bypass was used in repair of coarctation in 6.3% (37 of 591 records), and not used in 93.7% (554 of 591). Of the 37 patients with known CPB use, the aorta was cross-clamped in 33 (89.2%); data were missing in the remaining 4 patients (10.8%). In the population of patients with known cross-clamp time (33), the records are marked by incomplete field entries. Eighteen of the 33 (54.5%) records had missing field entries. Blood cardioplegia was used in 9 patients (27.3%); crystalloid cardioplegia in 6 (18.2%). It is not clear from this data whether there were patients with unrecorded associated VSD. This would explain the use of CPB and cardioplegia use. The difficulty, however, is that this explanation does not segregate those patients who had partial CPB to repair isolated coarctation. Incidence of type of CoA repair (subclavian flap, synthetic patch, resection with end-to-end anastomosis, or interposition graft) was analyzed with regard to patient age. In patients 1 month of age, resection with end-toend anastomosis was used in 70% of the records (135 of 193 patients), subclavian flap repair in 14% (27), and synthetic patch repair in 0.5% (1 patient); data were missing in 30 records (15.5%). In patients 1 month to 1

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