Methods: This retrospective study examined a total of 4007 congenital heart surgery procedures from 15 centers in the Congenital Heart Surgery Database between January 2018 and January 2023. International diagnostic and procedural codes were used for data entry. STAT (Society of Thoracic Surgeons and European Association for Cardiothoracic Surgery) mortality scores and categories were used for comparison of the data. Surgical priority status was modified from American Society of Anesthesiologist guidelines. Centers that sent more than 5 cases to the database were included to the study.
Results: Cardiopulmonary bypass and cardioplegic arrest were performed in 2,983 (74.4%) procedures. General risk factors were present in 22.6% of the patients, such as genetic anomaly, syndrome, or prematurity. Overall, 18.9% of the patients had preoperative risk factors (e.g., mechanical ventilation, renal failure, and sepsis). Of the procedures, 610 (15.2%) were performed on neonates, 1,450 (36.2%) on infants, 1,803 (45%) on children, and 144 (3.6%) on adults. The operative timing was elective in 56.5% of the patients, 34.4% were urgent, 8% were emergent, and 1.1% were rescue procedures. Extracorporeal membrane oxygenation support was used in 163 (4%) patients, with a 34.3% survival rate. Overall mortality in this series was 6.7% (n=271). Risk for mortality was higher in patients with general risk factors, such as prematurity, low birth weight neonates, and heterotaxy syndrome. Mortality for patients with preoperative mechanical ventilation was 17.5%. Pulmonary hypertension and preoperative circulatory shock had 11.6% and 10% mortality rates, respectively. Mortality for patients who had no preoperative risk factor was 3.9%. Neonates had the highest mortality rate (20.5%). Intensive care unit and hospital stay time for neonates (median of 17.8 days and 24.8 days, respectively) were also higher than the other age groups. Infants had 6.2% mortality. Hospital mortality was 2.8% for children and 3.5% for adults. Mortality rate was 2.8% for elective cases. Observed mortality rates were higher than expected in the fourth and fifth categories of the STAT system (observed, 14.8% and 51.9%; expected, 9.9% and 23.1%; respectively).
Conclusion: For the first time, outcomes of congenital heart surgery in Türkiye could be compared to the current world experience with this multicenter database study. Increased mortality rate of neonatal and complex heart operations could be delineated as areas that need improvement. The Congenital Heart Surgery Database has great potential for quality improvement of congenital heart surgery in Türkiye. In the long term, participation of more centers in the database may allow more accurate risk adjustment.
Although the beginning of congenital heart surgery in Türkiye goes back to 1960, there was no national database for congenital heart surgery until 2018. Database studies have been limited with the participation of some centers in international databases in our country. The main drawbacks of using international databases are the difficulty of analyzing own institutional data, limited participation of database studies due to costs, and risk of institutional data loss.
A new Congenital Heart Surgery Database (CHSD) was introduced in 2018 by the Children"s Heart Foundation in Türkiye. International diagnostic and procedural codes and risk scoring systems were used. An internet-based system was chosen to facilitate data collection, which is available for desktop computers, laptop computers, tablets, and smart phones. As a novel application, a real-time online reporting system was developed. Users can see all their data by using 10 different automated reports, including the total number of procedures, mortality rates, morbidity parameters, complications, intensive care unit (ICU) and hospital stay, extracorporeal membrane oxygenation (ECMO) rates, and outcomes. Users can instantly compare their results with the peer centers using Aristotle and STAT categories. The first harvest of the CHSD was published in 2021 with the participation of 12 centers and 2,307 procedures.[10]
In this second harvest, we aimed to analyze our current multicenter outcomes and compare them with the current results of international databases to reveal the areas that need improvement. We seek to encourage more national centers to participate in the project and to improve the potential for quality improvement.
Interfaces were designed by using Bootstrap technology. The SQL Server (Microsoft Corp., Redmond, WA, USA) was chosen as the database, and the ASP.NET and Visual Basic. NET were used as the software language. Ten real-time online analysis reports were created. No follow-up data was requested.
Statistical analysis
Statistical analysis was performed using SPSS
version 11.0 software (SPSS Inc., Chicago, IL, USA).
Pearson"s chi-square test was performed for categorical
data to determine whether the observed data were
significantly different from the overall results. Mean
and standard deviations (SD) were presented for
normally distributed variables and median (min-max)
values were used for skewed distributions. One
sample proportion test in R Studio version 1.1.463
(R Foundation for Statistical. Computing, Vienna,
Austria) was used for estimation of confidence interval
of the given values. A p-value <0.05 was considered
statistically significant.
Cardiopulmonary bypass and cardioplegic arrest were performed in 2,983 procedures (74.4%). On-pump beating heart technique was applied in 367 (9.1%) procedures. A total of 657 (16.3%) procedures were performed off-pump. Cardioplegia shifted towards single-dose del Nido or the Custodiol HTK solution over blood cardioplegia in recent years. Single-dose cardioplegia was used in 1,550 (36.8%) procedures. Intermittent tepid blood cardioplegia was preferred in 988 (24.6%) procedures. Intermittent cold blood cardioplegia was chosen in 346 (8.6%) procedures. Intermittent crystalloid cardioplegia was used in only 94 (2.3%) procedures. No statistical difference was observed between mortality rates of different cardioplegia techniques. Antegrade selective cerebral perfusion techniques were used in 228 (5.6%) procedures. Sixty-four (28%) patients died in this group (p<0.001). Fifty-four (1.3%) procedures were performed by using the hypothermic circulatory arrest technique, and mortality was observed in 21 (38.8%) procedures (p<0.001). Retrograde cerebral perfusion was used for 11 (0.2%) patients during circulatory arrest.
Overall mortality among 4,007 procedures was 6.7% (n=271). Additionally, 130 (3.2%) patients were transferred for further treatment or rehabilitation to another center. Most of them were patients operated on without CPB, such as premature neonates undergoing patent ductus arteriosus ligation. The mortality for procedures with CPB with cardioplegic arrest was 7.3% (n=219). Seventeen (4.6%) patients died in the on-pump beating heart surgery group, while the mortality rate was 5.3% (n=35) for those undergoing off-pump procedures.
Among all procedures, 623 (15.5%) were reoperations, and 214 (5.3%) had more than two sternotomies before; mortality rates were 8.1% and 4.2%, respectively (p=0.2). According to this study, resternotomy did not affect mortality. Minimally invasive surgeries grew in popularity, and 295 (7.3%) patients underwent these procedures without any mortality.
General risk factors
General risk factors were present in 891 (22.2%)
patients in the study. The primary risk factors
affecting mortality included prematurity (23.5%),
heterotaxy/dextrocardia (14.8%), low body weight
(<2,500 gr; 14.1%), and possessing more than two
risk factors (21.8%). Severe prematurity (<32 weeks)
did not affect mortality (5.9%). In this group,
the most common procedure was patent ductus
arteriosus ligation, none of which were open heart
operations. Mortality in patients without general risk factors was 5.1%. Details of the data are presented
in Table 1.
Preoperative risk factors
In the study, 761 (18.9%) patients had at least one
preoperative risk factor. The most common preoperative
risk factors affecting mortality were mechanical
ventilation (17.5%), pulmonary hypertension (11.6%),
circulatory shock (10%), and hepatic dysfunction
(33.3%). Presence of two or more preoperative risk factors caused 30.0 and 41.9% mortality, respectively.
The mortality rate was 3.9% among patients who had
no preoperative risk factors. Details of the preoperative
risk factors are outlined in Table 2.
Table 2. Preoperative risk factors
Age groups
Outcomes of the age groups were statistically
different in terms of mortality rates, ICU stay, and
hospital stay. In the study group, 610 (15.2%) patients
were neonates, 1,450 (36.2%) were infants, 1,803 (45%) were children, and 144 (3.6%) were adults. Neonates
had the highest mortality rate with 20.5% (p<0.001).
Intensive care unit and hospital stay times of neonates
were longer than other age groups (mean duration
of 17.8±21.1 days and 24.8±23 days, respectively;
p<0.001). Additionally, 36.1% of them had at least
one major complication. The modified ACC (MACC)
complexity score of the neonates was also higher than
the other age groups, with a mean score of 11.5±4. The
mortality rate was 6.2% in infants. Their mean ICU and
hospital stay times were 10.1±18.2 and 18±23.5 days,
respectively, and 17.8% of the infants experienced
at least one major complication. Children had the
best survival rate with 2.8% mortality. Their ICU
and hospital stay times were shorter than neonates
and infants (mean duration of 3.4±7.5 days and
11.1±14.3 days, respectively). The major complication
rate of the children (9.5%) was also less than neonates
and infants. The mortality rate of the adult congenital
age group was 3.5%. Their ICU and hospital stay
times and major complication rates were similar to
the children"s. All age groups" data are depicted in
Table 3, and mortality rates of age groups are shown
in Figure 1.
Figure 1. Mortality rates according to age groups.
Priority of procedures
It is generally accepted that surgical priority
categories of the procedures affect mortality and
morbidity significantly, but they are not usually
considered in standard database systems. Our simple
definition of priority categories may improve the
analysis of the outcomes. Rescue procedures had the
highest mortality rate, as expected (45.5%, p<0.001).
The mortality rate of emergent and urgent procedures
was 17.7% (p<0.001) and 9.4% (p=0.01), respectively.
In this study, 56.5% of the procedures were considered
elective cases, and their mortality rate was 2.8%.
Elective cases had statistically significantly lower mortality rates than the other priority classes and
overall mortality rates (2.8% vs. 6.8%, p<0.001). Major
complication rates were correlated with the priority
status as well. All detailed data are shown in Table 4.
Table 4. Outcomes according to the priority of the procedures
Observed and expected STAT score mortality
rates of the procedures
Expected mortality rates of the procedures
according to the STAT scoring system were very
well defined. Observed mortality rates of the
procedures in this study and their comparison with
the STAT scoring system are shown in Table 5.
Overall mortality in this study was higher than
expected (6.7% vs. 4.3%). Although the observed
mortality rates of the procedures in the first three
STAT categories were comparable with the expected
values, improvement may be necessary for some
procedure subgroups. Norwood procedure had the
highest mortality rate (56.7%). Considering that the
expected mortality rate is 23.6%, there is a need for
significant improvement in hypoplastic left heart
surgery. Mortality for ASO was 8%. While the
mortality rate of ASO with ventricular septal defect
(VSD) repair was 14.1%, ASO with VSD and aortic
arch repair was 40%. Those were almost two times
higher than expected. Furthermore, mortality of
aortic arch repair was almost four times higher than
expected (28.3% vs. 7.8%). Fontan modifications,
tetralogy of Fallot (TOF) repair, Rastelli procedure,
truncus arteriosus, and total anomalous pulmonary
venous connection repair had higher than expected
mortality rates. Aortopulmonary shunt and pulmonary
banding operations had also higher mortality rates
than expected mortality rates.
Table 5. Observed and expected STAT score mortality rates of the procedures
Table 5 shows information about the current trend in surgical techniques. For example, 90% of Fontan procedures were performed with extracardiac conduit; the remaining procedures were lateral tunnel modifications. The fenestration rate was 57%. Among 361 procedures for TOF repair, 59.8% had transannular repair. Nontransannular patch with infundibulotomy was performed in 28.3%, and 4.4% of the patients needed right ventricle to pulmonary artery conduit. Transatrial approach in TOF repair was performed in only 7.2% of the patients.
Extracorporeal membrane oxygenation results
In this series, 163 (4.0%) patients required
ECMO support during hospital stay. Almost all
patients underwent venoarterial ECMO with
central cannulation. Two patients needed peripheral
cannulation, and three needed venovenous ECMO
support. Out of the total number of patients who
were on ECMO support, 79 (48.4%) patients were
weaned successfully from ECMO support, and
56 (34.3%) patients were discharged. While the
median duration for ECMO support in surviving
patients was 5 (2-55) days, the median ECMO support
duration in nonsurviving patients was 8 (1-37) days.
Most common indication was low cardiac output
syndrome with 40.5% survival rate. Unable to wean
from CPB was the second most common indication
for ECMO, and they had the lowest survival rate
(25%). Seventeen patients underwent ECPR with
six survivors (35.2%). Details of the ECMO use are
shown in Table 6.
Table 6. Extra corporeal membrane oxygenation results
Scoring categories
Expected mortality rates for the categories of
expert consensus scoring systems, such as ABC and
ACC scores, were not well defined. The MACC score
was utilized to compare outcomes across centers and
specific time periods, and the MACC categories and
mortality rates are shown in Table 7. As expected,
mortality and morbidity rates (reflected by ICU
and hospital stay) increased in correlation with the
categories.
Table 7. Number and outcomes according to MACC categories
The STAT scoring system categories were well defined and reflected the mortality rates of the large cumulative congenital heart surgery data of STS and EACTS databases. For this reason, STAT categories were chosen for comparing our data with the world experience. Observed and expected mortality rates of STAT scoring categories are shown in Tablettable11> 8 and Figure 2. Although our results were similar in the first three categories, a marked difference was detected for the fourth and fifth STAT categories. Our mortality rates were higher than expected for procedures with high complexity scores. It shows that efforts for improvement should be focused on more complex procedures.
Table 8. Number and outcomes according to STAT categories
Comparison of the centers
Bubble graphs in Figure 3 show the comparison of
the centers according to the STAT scores. The X-axis shows the mean complexity scores of the procedures
performed by a specific center. The Y-axis shows the
overall outcome of all procedures of a specific center.
Sizes of the bubbles show the number of the procedures
performed at related centers.
This second harvest of the CHSD delineated a limited part of the current practice of congenital heart surgery in Türkiye. Although data is varied, it is estimated that approximately 7,000 to 9,000 congenital heart operations are performed annually in Türkiye.[4,5] Establishment of new congenital heart surgery centers, increased patient transportation capacity, and enhanced prenatal diagnosis capabilities made it possible for almost all children born with congenital heart disease (CHD) to access proper healthcare services. The best way to ensure high-quality care that meets world standards for patients is by implementing effective quality management and improvement policies. Data collection is the first step of quality improvement. Benchmarking and comparison of outcomes with the world experience have great potential for improving results.[1,2]
Overall mortality was 6.7% in this study. Considering the overall 4.3% mortality rate of STS and EACTS databases, outcomes in this study need improvement.[9] The impact of general and preoperative risk factors, the emergency status of patients, and age categories significantly influenced mortality rates. Although it is not always possible, timely intervention in stabilized patients may improve the results. Nevertheless, considering the small size of the CHSD, comparison of overall results may be unfair. Expected and observed mortality rates of the procedures, demonstrated in Table 5, may provide better analysis for the delineation of specific procedures that need improvement.
Some of the common procedures, such as TOF repair, Fontan modifications, Rastelli operation, and aortic arch repair, had more than expected mortality rates. Arterial switch operation with/without VSD, aortic arch repair, and Norwood procedures also had higher mortality rates than expected. Better overall national outcomes can only be possible by improving the performance of each center. Identification of key areas in need of improvement may facilitate this process.[2-4] All areas for quality improvement should be evaluated to find weak points. Strategies may be focused on early referral for surgery, intensive preoperative corrective therapies, the use of checklists, minimizing human errors, performance monitoring, training, continuing education, and, more importantly, finding an explanation for the outcome through a forensic approach.[11] Significant variation in outcomes also exists among centers in the USA.[12] High-volume centers demonstrate superior outcomes compared to other centers for complex neonatal and high-risk procedures.[13,14] According to the new "Recommendations for centers performing pediatric heart surgery in the United States" guideline, centers are divided into comprehensive care and essential care centers based on their case volume, and it was suggested that high-risk operations should be performed in comprehensive care centers.[12] Same recommendation is also evident for the European centers.[15] The same concept of concentrating the complex cases in specialized centers may be beneficial for our centers to improve patient care in Türkiye. In this database study, almost all patients" specific risk factors were analyzed. We believe that a better outcome analysis may be possible to demonstrate not only the procedures performed but also patient-specific risk factors. The STAT scoring system, which is based on the statistics of EACTS and STS big data, does not take into account any patient-specific risk factors. However, they argue that the status of individual patients in such a vast database does not significantly impact the overall outcome. Nevertheless, many studies demonstrated the accuracy and feasibility of outcome analysis by using STAT mortality categories across the wide spectrum of distinct congenital heart surgery operations, including infrequently performed procedures.[16] Another drawback of the STAT scoring system is that some of the challenging surgeries, such as the Ross procedure, are in the second category. In practice, the Ross procedure has been performed only by some experienced surgeons and centers. This does not mean that Ross procedure is a simple, low-risk operation, despite statistics showing low mortality and morbidity. Recent updates to STAT mortality scores and categories now encompass a broader range of procedure codes, also considering the risk associated with operations involving multiple components.[17] Conversely, the Aristotle score is based on expert opinions and considers patient-specific risk factors. The highest ABC, which represents the complexity of the procedures, is 15 points, and the ACC score considers the patient's clinical status at the time of the operation. General risk factors, preoperative risk factors, surgical priority, and organ functions are all included and increase the complexity point from 15 to 25 points.[18] From our perspective, the ACC score appears to be more accurate in evaluating small groups of patients. In this study, we also used an MACC score, which may be beneficial for comparison of outcomes between participating centers.
Morbidity is as important as mortality for quality measurement. The most important parameters defining morbidity are ICU and hospital stay times, which are highly correlated with the complications occurring after the operations.[9,17,18] The neonatal age group had the highest mortality rate and had the longest ICU and hospital stays in this study. Knowledge of potential complications, whether major or minor, is also of great value when informing patients and their families prior to surgeries. Knowing the median durations of ICU and hospital stays, as well as the expected percentages of specific complications associated with a particular procedure, may assist surgeons in providing information to the families.
Several national and international databases are present for congenital heart surgery.[19-21] Healthcare systems aim to ensure and organize care for individuals with CHD, focusing on clinical outcomes and costs at a population level to ensure coordinated healthcare delivery and optimal results. Therefore, extensive multicenter databases are virtually indispensable for supplying the information required by healthcare systems. It is obvious that comprehensive databases affect national policies as well and make it possible to act in the right direction at the right time for the improvement of the healthcare of patients with CHD. We hope that the CHSD initiative will cover all of the country in the near future. The CHSD may provide not only the improvement of healthcare of patients with CHD but also facilitate and transform healthcare policies.
Society of Thoracic Surgeons congenital heart surgery database is the oldest database and has the highest number of patients, with the participation of approximately 90% of all centers from the USA. According to the 2020 report, they have 535,184 operations since the inception of the database.[22] Numerous reports and research, which have been performed throughout the years, have been the mainstay of the knowledge about CHD. The STS congenital database not only publishes their studies in the scientific area but also publicly reports outcomes according to their mortality risk model. There are pros and cons of public reporting, which may force centers for better outcomes. On the other hand, some centers may become less reluctant to accept patients with high risk of mortality.[23-25] Although controversy still exists in the USA about whether public reporting should be done or how it should be done, we believe that the CHSD might have a module for public information in the future.
Artificial intelligence-based algorithms have recently been introduced in clinical assessment, diagnosis, procedure planning, and intervention management in pediatric cardiology and congenital heart surgery.[26,27] Effective artificial intelligence model training relies on comprehensive and diverse datasets. This emphasizes the importance of large and accurate databases.[28] The integration of artificial intelligence into clinical practice may have profound implications, such as tailored treatment planning, costeffectiveness, and further enhancing patient care.[29]
Analysis of outcomes, according to the currently available scoring systems for congenital heart surgery, is not new in Türkiye. Some centers use their own database for the comparison of their results with the current world statistics as an effort for quality improvement in congenital heart surgery.[30-32] However, a national database was not available for all centers with a standardized nomenclature and scoring system until the CHSD. It has been shown that the improvement process immediately begins when centers participate in a database study and when they start analyzing and comparing their outcomes with other centers.[33]
This study has several limitations. First, it represents only a small part of the national congenital heart surgery results. All centers that shared their data with more than five patients were included in the study. Some centers joined with all their data, but some centers sent only a part of their cases from a specific timeframe, and no verification of the data has been performed yet. The results of the patients who were transferred to another center are unknown. The database shows the results of procedures, and no follow-up data is available. Patients who underwent different operations in different hospitalization periods were considered different procedures. Since the database does not use patients' identity information, operations that a patient undergoes in different hospitals are processed as different patients.
In conclusion, outcomes of congenital heart surgery in Türkiye could be compared to the current world experience with this multicenter database study. Several critical areas requiring improvement were identified. By creating the Congenital Heart Surgery Database, the Children"s Heart Foundation is taking a crucial step in enhancing care for children with congenital heart disease in Türkiye. A real-time online reporting system provides instant detailed analysis of the outcomes and comparison of the results. Use of international parameters and scoring systems makes it possible to compare the results with the world experience. In the long term, we anticipate that the participation of more centers in the database will allow more accurate risk adjustment. We invite all centers to participate fully and honestly in this important initiative for the quality improvement of congenital heart disease in our country.
Ethics Committee Approval: The study protocol was approved by the Acıbadem University Ethics Committee (date: 30.09.2021, no: ATADEK 2021 19/12). The study was conducted in accordance with the principles of the Declaration of Helsinki.
Patient Consent for Publication: A written informed consent was obtained from the patients and/or parents of the patients.
Data Sharing Statement: The data that support the findings of this study are available from the corresponding author upon reasonable request.
Author Contributions: Idea/concept: E.E., S.B., O.Y., N.S., Y.K.Y., R.T., A.K., S.S., S.E., V.C., A.A., M.K., O.K., I.Ş., F.Ö., M.B., B.S., Y.A., S.H., Ç.B., İ.S.O., O.N.T., G.C., A.D., B.T., M.Ö., C.T.S.; Design: E.E., S.B., Y.K.Y., C.T.S.; Control/ supervision: Y.K.Y., B.T., Y.A., C.T.S., E.E.; Data collection and/ or processing: S.B., E.E.; Analysis and/or interpretation: E.E., S.B., Y.K.Y., A.K., Y.A., C.T.S.; Literature review: E.E., S.B., Y.K.Y., A.K., Y.A., C.T.S.; Writing the article: S.B., E.E.; Critical review: E.E., S.B., Y.K.Y., A.K., Y.A., C.T.S.; References and fundings materials: E.E., S.B.
Conflict of Interest: The authors declared no conflicts of interest with respect to the authorship and/or publication of this article.
Funding: The authors received no financial support for the research and/or authorship of this article.
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