Andreas Beckmann, S. Dittrich, C. Arenz, et al and German Quality Assurance / Competence Network for Congenital Heart Defects Investigators
Thorac Cardiovasc Surg. 2021 Dec;69(S 03):e21-e31. doi: 10.1055/s-0041-1722978. Epub 2021 Feb 26. PMID: 33638137; PMCID: PMC7920329.
Take Home Message:
- Large registries can be successfully maintained and can provide valuable information
- Registries can form a basis for internal and external quality assurance for participating institutions.
- Mortality in CHD interventions and surgeries is low. It is highest in neonates with high risk complex diseases, that require multiple procedures.
- In Germany, mortality for isolated surgical procedures is minimal and rises to about 12% in high risk, STA5 procedures.
Commentary from Dr. Anna Tsirka (Hartford, CT, USA), section editor of Pediatric and Fetal Cardiology Journal Watch
Introduction
In Germany, the German Society for Thoracic and Cardiovascular Surgery (DGTHG) and German Society for Pediatric Cardiology and Congenital Heart Defects (DGPK) took the initiative to create a multicenter registry study concerning interventional and surgical therapies in patients with CHD. The nationwide registry started in 2012.
This report presents data from the first 6 years of data entry. Each included patient receives a unique personal identification (PID), valid for life. Based on the PID, any invasive interventional or cardiac surgical procedure can be assigned exactly to each individual patient, even if the treatment is provided in different institutions. This enables longitudinal, procedure-related data acquisition, as well as short-, mid- and long-term evaluations.
Risk adjustment models for operations and interventions were implemented in 2014. The risk group classification for operations is performed according to the society of thoracic surgeons (STAT) mortality score while risk group adjustment for interventions is based on the internationally acknowledged Bergersen’s score. In addition to procedure-related data, various indicators, including the occurrence of adverse events, in-hospital mortality, and 30-day and 90-day mortality, are evaluated. Major and minor adverse events following surgical procedures are classified according to the society of thoracic surgeons (STS) morbidity classification.
Risk adjustment models for operations and interventions were implemented in 2014. The risk group classification for operations is performed according to the internationally recognized society of thoracic surgeons-european association for cardio-thoracic surgery (STAT) mortality score 4 5 while risk group adjustment for interventions is based on the internationally acknowledged Bergersen’s score. 6 These classifications cover five categories for surgical and four for interventional procedures. However, it has to be remembered that the two risk scores are not comparable, as they are based on different morbidity expectations and different evaluations of special features and complications. In addition to procedurerelated data, various indicators, including the occurrence of adverse events, in-hospital mortality, and 30day and 90-day mortality, are evaluated. Major and minor adverse events following surgical procedures are classified according to the society of thoracic surgeons (STS) morbidity classification.
Results
Data and results encompass the period between 2013 to 2018 collected from 20 to 24 departments performing surgical and from 24 to 30 departments carrying out interventional procedures depending on the year.
A total number of 35,730 patients was included, leading to 39,875 cases, and 46,700 procedures. The cases could be subdivided into 17,259 interventional, 21,027 surgical cases, and 1,589 with multiple procedures ( hybrid procedures are included under multiple procedures and comprised less than 1% of all procedures). Overall, 4,708 (11.8%) of all cases were performed in neonates, 10,047 (25.2%) in infants, 19,351 (48.5%) in children/adolescents at age of 1 to 18 years, and 5,769 (14.5%) in adults.
Mortality by age and type of procedure is shown below:
The observed mortality rate was lowest in interventional cases and highest for cases requiring multiple procedures with a range of 6.2 to 10.4%. This can be explained by the fact that in the majority of cases, the combination of
more than one surgical and interventional procedure is frequently requires in newborns and infants with complex heart malformations, representing the highest risk groups.
Mortality was minimal in procedures performed for isolated defects. It increased by STAT risk category, as expected, but even in the highest risk category STAT5) the vast majority of patients survived (87.8%). Mortality by defect and stat category is shown in the table below:
Similarly, complications were the lowest in interventional cases and highest in the patients who underwent multiple procedures as shown in the figure below:
Adverse events followed the same pattern. Over 90% of interventional cases were uncomplicated, surgical cases had some adverse events in about 36% of the cases, while about 56% of cases with multiple interventions had some adverse event. Of those, 8.7% were serious or “catastrophic”
Over the registry period, the overall incidence of mortality or adverse events did not change.
Conclusion
The creation of large registries is possible and can give valuable data.
Overall mortality in congenital heart disease in Germany is low. Interventional procedures have significantly lower risk than surgical procedures. It has to be emphasized, however, that interventions and operations must not be understood as competing, but as complementary therapeutic options. Even in patients with the same anatomic diagnosis, the selection criteria for interventional or surgical procedures, may differ considerably.
Registry data of course have limitations, as specific patient characteristics cannot be distinguished. Nevertheless, the data obtained is valuable and can provide longitudinal trends overtime, as well important comparative feedback for specific centers.