Sven Dittrich1, Claudia Arenz2, Otto Krogmann3, Anja Tengler4, Renate Meyer5, Ulrike Bauer6, Michael Hofbeck7, Andreas Beckmann8, Alexander Horke9. 1. Department of Pediatric Cardiology, Friedrich-Alexander-Universitat Erlangen-Nurnberg, Erlangen, Germany. 2. Department of Pediatric Heart Surgery, University of Bonn, Bonn, Germany. 3. Clinic for Pediatric Cardiology - Congenital Heart Defects, Heart Center Duisburg, Duisburg, Germany. 4. Department of Pediatric Cardiology and Intensive Care, Ludwig-Maximilians-Universitat Munich, Munich, Germany. 5. BQS Institute for Quality and Patient Safety, Hamburg, Germany. 6. National Register for Congenital Heart Defects, Berlin, Germany. 7. Department of Pediatric Cardiology, Pulmology and Intensive Care, University Children's Hospital, Tübingen, Germany. 8. German Society for Thoracic and Cardiovascular Surgery, Berlin, Germany. 9. Division of Congenital Heart Surgery, Hannover Medical School, Hannover, Germany.
Abstract
BACKGROUND: The annual report of the German Quality Assurance of Congenital Heart Disease displays a broad overview on outcome of interventional and surgical treatment with respect to patient's age and risk categorization. Particular features of the German all-comers registry are the inclusion of all interventional and surgical procedures, the possibility to record repeated treatments with distinct individual patient assignment, and to record various procedures within one case. METHODS: International Pediatric and Congenital Cardiac Code terminology for diagnoses and procedures as well as classified adverse events, also recording of demographic data, key procedural performance indicators, and key quality indicators (mortality, adverse event rates). Surgical and interventional adverse events were classified according to the Society of Thoracic Surgeons and to the Congenital Heart Disease Adjustment for Risk Method of the congenital cardiac catheterization project on outcomes. Annual analysis of all cases and additional long-term evaluation of patients after repair of Fallot and primary treatment of native coarctation of the aorta were performed. RESULTS: In 2020, 5,532 patients with 6,051 cases (hospital stays) with 6,986 procedures were treated in 23 German institutions. Cases dispense on 618 newborns (10.2%), 1,532 infants (25.3%), 3,077 children (50.9%), and 824 adults (13.6%). Freedom from adverse events was 94.5% in 2,795 interventional cases, 67.9% in 2,887 surgical cases, and 42.9% in 336 cases with multiple procedures (without considering the 33 hybrid interventions). In-hospital mortality was 0.5% in interventional, 1.6% in surgical, and 5.7% in cases with multiple treatments. Long-term observation of 1,632 patient after repair of Fallot depicts the impact of previous palliation in 18% of the patients on the rate of 20.8% redo cases. Differentiated analysis of 1,864 patients with native coarctation picture clear differences of patient, age, and procedure selection and outcome. The overall redo procedure rate in this patient population is high with 30.8%. CONCLUSION: Improvement in quality of care requires detailed analysis of risks, performance indicators, and outcomes. The high necessity of redo procedures in patients with complex congenital heart disease underlines the imperative need of long-term observations. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).
BACKGROUND: The annual report of the German Quality Assurance of Congenital Heart Disease displays a broad overview on outcome of interventional and surgical treatment with respect to patient's age and risk categorization. Particular features of the German all-comers registry are the inclusion of all interventional and surgical procedures, the possibility to record repeated treatments with distinct individual patient assignment, and to record various procedures within one case. METHODS: International Pediatric and Congenital Cardiac Code terminology for diagnoses and procedures as well as classified adverse events, also recording of demographic data, key procedural performance indicators, and key quality indicators (mortality, adverse event rates). Surgical and interventional adverse events were classified according to the Society of Thoracic Surgeons and to the Congenital Heart Disease Adjustment for Risk Method of the congenital cardiac catheterization project on outcomes. Annual analysis of all cases and additional long-term evaluation of patients after repair of Fallot and primary treatment of native coarctation of the aorta were performed. RESULTS: In 2020, 5,532 patients with 6,051 cases (hospital stays) with 6,986 procedures were treated in 23 German institutions. Cases dispense on 618 newborns (10.2%), 1,532 infants (25.3%), 3,077 children (50.9%), and 824 adults (13.6%). Freedom from adverse events was 94.5% in 2,795 interventional cases, 67.9% in 2,887 surgical cases, and 42.9% in 336 cases with multiple procedures (without considering the 33 hybrid interventions). In-hospital mortality was 0.5% in interventional, 1.6% in surgical, and 5.7% in cases with multiple treatments. Long-term observation of 1,632 patient after repair of Fallot depicts the impact of previous palliation in 18% of the patients on the rate of 20.8% redo cases. Differentiated analysis of 1,864 patients with native coarctation picture clear differences of patient, age, and procedure selection and outcome. The overall redo procedure rate in this patient population is high with 30.8%. CONCLUSION: Improvement in quality of care requires detailed analysis of risks, performance indicators, and outcomes. The high necessity of redo procedures in patients with complex congenital heart disease underlines the imperative need of long-term observations. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).
Until now obligatory quality assurance measure, according to § 136ff Social Code Book V,
was suspended for treatment of patients with congenital heart disease (CHD) for various
reasons. Quality of care has a major impact on patients' long-term outcome including quality
of life, especially in CHD. Therefore, since 2012 the German Society for Thoracic and
Cardiovascular Surgery (DGTHG) and German Society for Pediatric Cardiology and Congenital
Heart Defects (DGPK) as the scientific societies execute a multicenter registry study
concerning interventional and surgical therapies in patients with CHD. The structure of the
database has been described in detail previously. 1
The voluntary German Registry for Quality Assurance in CHD (Nationale Qualitätssicherung
Angeborene Herzfehler) has been approved by the Charité's Ethics Committee (code number:
EA2/011/11). The structure of the registry, data acquisition, and evaluation is in
accordance with the guidelines of “Good Epidemiological Practice,” 2 “Good Hospital Practice,” 3 and the Declaration of Helsinki for medical research
involving human subjects. 4 The registry contains
detailed information on diagnoses and procedures, which enable detailed risk categorization
5
6 in nearly 90% of cases. Severity of adverse events
is assessed in a standardized manner according to patient's outcome. 5
7 As each patient is distinctly identifiable by his
own life-long lasting pseudonymization number, analyses of the data can refer to patients,
cases (hospital stays), or procedures. Each year, the responsible scientific societies write
an annual report based on two types of analyses: the national report summarizes aggregated
and anonymized results of all participating institutions, compared with the previous year.
In addition, separate institution-related reports contain the analyses of each participating
heart center in comparison with the national results. Due to contractual arrangements, the
institutional report is confidential and not intended for public access. Upon request, each
institution can receive an electronic copy of its evaluated data for further use (e.g.,
transfer to the European Congenital Heart Surgeons Association database: https://echsacongenitaldb.org ). The purpose of
this report is to provide a public comprehensive annual update of the activities and
outcomes from the German National Report on CHD 2021.
Methods
Voluntary online data submission into the database with the goal of 100% coverage as
previously described. 1 All patients/parents gave
written consent. All data sets were monitored with respect to data integrity before case
closure. Source data were not monitored. The annual report includes only completed cases.
Coding of diagnoses and procedures is based on the International Pediatric and Congenital
Cardiac Code (IPCCC). 8 Completeness of recorded
procedures was estimated by comparison with the German Heart Surgery Report 2020 9 and the online available Deutscher Herzbericht 2021 (
www.herzstiftung.de ).
Risk Stratification
All cases intended as single interventional treatment were assigned to risk categories 1
to 4 according to the catheterization for Congenital Heart Disease Adjustment for Risk
Method. 5 All cases intended as surgical treatment
were assigned to risk categories 1 to 5 according to the Society of Thoracic Surgeons
(STS)-European Association for Cardio-Thoracic Surgery (EACTS) mortality categories. 6 Details are provided in the Supplementary Material.
Risk stratification of cases with multiple procedures and those starting with a hybrid
procedure was not possible due to the lack of established risk categories for these
procedures.
Key Performance Indicators
Length of hospital stay, the need and length of intensive care treatment, the need and
length of mechanical ventilation, procedure time, and the requirement of blood transfusion
are general key performance indicators presented in this report. In addition, specific key
performance indicators were analyzed: use of fluoroscopy, fluoroscopy times, data from
cardiopulmonary bypass (CPB), and the use of near-infrared spectroscopy.
Key Quality Indicators
In the German National Report mortality in-hospital, 30, and 90 days after first
procedure is analyzed. Adverse events are recorded based on the IPCCC nomenclature. In
addition, the number of cases without adverse events is analyzed. Severity of adverse
events was categorized according to patient's outcome by the supplying physician and
according to the definitions of adverse event severity for congenital cardiac
catheterization 5 or the definition of major
complications of the STS Congenital Heart Surgery Database (STSCHSD) database. 7 Unplanned redo procedures and patient's death trigger
automatically notification of an adverse event with severity grades 4 or 5 (“major” or
“catastrophic”). Observed mortality and morbidity rates are compared with published data
if available. 5
6None: no harm, no change in condition, and may have required monitoring to assess for
potential change in condition with no intervention indicated.Minor: transient change in condition, not life-threatening, condition returns to
baseline, required monitoring, required minor intervention such as holding a
medication, or obtaining laboratory test.Moderate: transient change in condition may be life-threatening if not treated,
condition returns to baseline, required monitoring, required intervention such as
reversal agent, additional medication, transfer to the intensive care unit (ICU) for
monitoring, or moderate transcatheter intervention to correct condition.Major: change in condition, life-threatening if not treated, change in condition may
be permanent, may have required an ICU admission or emergent readmit to hospital, may
have required invasive monitoring, and required interventions such as electrical
cardioversion or unanticipated intubation, or required major invasive procedures or
transcatheter interventions to correct condition.Catastrophic: any death, and emergent surgery, or heart–lung bypass support
(extracorporeal membrane oxygenation [ECMO]) to prevent death with failure to wean
from bypass support.
Definition of Major Complications in Cases with Operations
Major complications are defined according to complication codes in the STS Congenital
Heart Surgery Database (STSCHSD) Data collection form, Version 2.50 as cited in Jacobs et
al 7 :Postoperative acute renal failure requiring temporary or permanent dialysis.Postoperative neurologic deficit persisting at discharge.Postoperative atrioventricular block requiring permanent pacemaker.Postoperative mechanical circulatory support.Phrenic nerve injury/paralyzed diaphragm.Unplanned reoperation.Any death.All other recorded adverse events according to the IPCCC were rated as minor (most
frequent in 2020: postprocedural pulmonary infection 15.80.21, pleural effusion requiring
drainage 15.80.61, arrhythmia requiring drug treatment 11.00.30, postprocedural
chylothorax 15.80.55, sternum left open: elective [planned] 15.03.57).
Evaluation and Data Presentation
All cases are analyzed with respect to the initial treatment and after allocation to one
of four groups: surgery, intervention, multiple procedures, and hybrid procedures. In
addition to this analysis of the entire cohort, we performed detailed analyses of 15 index
procedures containing 6 defined interventional and 9 defined surgical procedures in
specific subgroups of CHD.
Longitudinal Evaluation of Patient's Medical Careers
All patients who since 2012 received surgical correction for Fallot malformation and all
patients who received surgical or interventional treatment of native coarctation of the
aorta (CoA) were analyzed for requirement of further invasive treatment.
Results
Registry Data Report 2020
The number of patients, cases (number of hospital stays), and procedures, which
constitute the 2020 data basis of the registry, are shown in Fig. 1 . Taking together all surgical and
interventional cases, 23 German centers treated 6,051 cases under the terms of quality
assurance. Eighteen participating centers provided detailed surgical data from 2,795
single surgery cases and 336 cases with planned multiple procedures, altogether 3,713
surgeries on CHD. In-hospital lethality was 1.6% in all single surgery cases and 5.7% in
all cases with planned multiple procedures ( Fig. 2
). In comparison, the German Heart Surgery Report based on anonymous self-disclosure of 78
institutions in 2020 counts 5,637 operations on CHD. Reported lethality was 2.7% in cases
with extracorporeal bypass use and 2.1% in cases without. 9 In this quality registry data report, 23 participating centers provided
detailed data from 3,226 interventions compared with the reported number of 5,239
interventions by anonymous self-disclosure of 32 institutions published in the Deutscher
Herzbericht 2021 ( www.herzstiftung.de ).
Thus, overall completeness of quality recorded procedures nationwide was 66% for surgical
and 62% for interventional procedures and larger at the participating centers.
Fig. 1
Numbers of patients, cases, and procedures. Note that 9.4% of 5,432
patients were treated two or more times in hospital. In 9.2% of the 6,051 cases,
patients received two or more procedures, which was initially planned only in 5.6% of
the cases. The rate of surgical procedures exceeded the rate of planned single
surgical cases indicating a major role of surgery in redo procedures.
Fig. 2
Key quality indicators in different case subgroups. ( A ) Key
quality indicators of 2,795 cases with single interventional procedures. Adverse
events were recorded in 5.5% of the cases. The rate of major or catastrophic adverse
events was 1.5% in all cases. Severity of 6.5% of adverse events recordings (0.4% of
all cases) was not classified. ( B ) Key quality indicators of 2,887 cases with
single surgical procedures. Adverse events were recorded in 32.1% of the cases. The
rate of major adverse events was 9.9% in all cases. Severity of 1.3% of adverse events
recordings (0.4% of all cases) was not classified. ( C ) Key quality indicators
of 336 cases with multiple procedures. Adverse events were recorded in 57.1% of the
cases. In this case group subsequent procedures were present in 100% by definition and
were not conditioned by complications. Note: different x -axis scales. The
definitions of major and minor adverse events for surgical and interventional cases
differ fundamentally and are not suitable for direct comparison.
Numbers of patients, cases, and procedures. Note that 9.4% of 5,432
patients were treated two or more times in hospital. In 9.2% of the 6,051 cases,
patients received two or more procedures, which was initially planned only in 5.6% of
the cases. The rate of surgical procedures exceeded the rate of planned single
surgical cases indicating a major role of surgery in redo procedures.Key quality indicators in different case subgroups. ( A ) Key
quality indicators of 2,795 cases with single interventional procedures. Adverse
events were recorded in 5.5% of the cases. The rate of major or catastrophic adverse
events was 1.5% in all cases. Severity of 6.5% of adverse events recordings (0.4% of
all cases) was not classified. ( B ) Key quality indicators of 2,887 cases with
single surgical procedures. Adverse events were recorded in 32.1% of the cases. The
rate of major adverse events was 9.9% in all cases. Severity of 1.3% of adverse events
recordings (0.4% of all cases) was not classified. ( C ) Key quality indicators
of 336 cases with multiple procedures. Adverse events were recorded in 57.1% of the
cases. In this case group subsequent procedures were present in 100% by definition and
were not conditioned by complications. Note: different x -axis scales. The
definitions of major and minor adverse events for surgical and interventional cases
differ fundamentally and are not suitable for direct comparison.
Age and Gender Distribution
The majority of treatments were performed in children and adolescents ( Table 1 ). Note that 10.2% of the cases were treated in
newborns and 13.6% in adults. Males were more affected by treatment for CHD than females.
Table 1
Age and gender distribution of all cases
Numbers
Percentage
Newborn
618
10.2
Infants (30 d-year)
1,532
25.3
Children and adolescents
3,077
50.9
Adults
824
13.6
Males
3,237
53.5
Females
2,814
46.5
Note: Assignment of patient's age was done at the date of the first procedure of
every case.
Note: Assignment of patient's age was done at the date of the first procedure of
every case.
Case Complexity
This report for the sake of space disclaims the listing of cardiac and noncardiac
codiagnoses as well concomitant procedures. The numbers of elective redo cases with
previous single or multiple cardiac procedures are shown in Fig. 3 . In 2020, first treatment for CHD in Germany
was performed in 48% of interventional, 57% of surgical, and 62.5% of cases with multiple
procedures.
Fig. 3
Pretreatment of patients in different case subgroups. ( A ) Cases
intended for single interventional treatment. ( B ) Cases intended for single
surgical treatment. ( C ) Cases with multiple procedures. The rate and the
distribution of different pretreatments is expressed in the bar charts.
Pretreatment of patients in different case subgroups. ( A ) Cases
intended for single interventional treatment. ( B ) Cases intended for single
surgical treatment. ( C ) Cases with multiple procedures. The rate and the
distribution of different pretreatments is expressed in the bar charts.Details are listed in Table 2A for all cases and
for those with defined interventional ( Table 2B )
or surgical ( Table 2C ) index procedures.
Interventional cases required the least resources. Hospital stay was 2 days in median
while the 75 percentile lay at 3 days. Intensive care treatment was applied in 13.5% of
the cases and most cases (83%) were performed under analgosedation without mechanical
ventilation. Note that 6.8% of the cases were performed without fluoroscopy (mainly
Rashkind procedures in dextro-transposition of the great arteries and atrial septal defect
[ASD] closures, see index procedures). Analysis of interventional index procedures
revealed significant differences among the different subgroups of these patients. Most
frequent intervention were ASD closure with 493 cases. For this procedure, the rate of
general anesthesia was 29%, thereby above average. Rare and complex interventions like
ventricular septal defect (VSD) closure and native CoA treatment required longer
in-hospital stay and in cases with native CoA the largest numbers of ICU stays (29%) and
intubations (20%). Beside the large spectrum of age in this subgroup 25% of the patients
were newborns or small infants younger than 4 months of age. Only half of the
interventional units reported these complex procedures. Percutaneous pulmonary valve
implantation is the most laborious interventional index procedure, which is expressed by
longest procedure and fluoroscopy times. The median procedure time of 76 minutes and the
median fluoroscopy time of 10.1 minutes in the analysis of all interventional cases was
slightly higher compared with those other interventional index procedures (compare Table 2A and B
).
Data are given as numbers, percentages or median (25. – 75. percentiles).
Abbreviations: ASD, atrial septal defect; AVSD, atrioventricular septal defect;
CoA, coarctation aortae; CPB, cardiopulmonary bypass; ICU, intensive care unit;
NIRS, near-infrared spectroscopy; PDA, patent ductus arteriosus; PPVI,
percutaneous pulmonary valve implantation; TCPC, total cavopulmonary connection;
TGA, transposition of great arteries; VSD, ventricular septal defect.Data are given as numbers, percentages or median (25. – 75. percentiles).Surgical cases required more resources. Intensive care treatment in 94.4% of the cases
with a median length of stay of 4 days and blood transfusions in 57.2% were required.
Again, analysis of index procedures revealed significant differences. Patients with ASD,
VSD, or native CoA were far younger than patients in the interventional subgroups. VSD
closure was the most frequent surgical procedure with 261 cases. Case performance in VSD
closure appears highly standardized with narrow interquartile ranges for perfusion and
aortic clamp times as well as for the duration of hospital stay. The complex nature of
univentricular heart treatment is visible in the information of Norwood and total
cavopulmonary connection (TCPC) cases. Main diagnosis in Norwood cases was hypoplastic
left heart syndrome (HLHS) in 81.3%. Eighteen patients (24%) received bilateral pulmonary
arterial banding before the Norwood procedure. Norwood patients had longest perfusion
times (median 182 minutes), longest mechanical ventilation (median 130 hours), longest ICU
stay (median 21 days), and longest in-hospital stay (median 47 days). Three out of 18
pediatric congenital cardiac surgery units did not perform Norwood operations in 2020.
HLHS was also the most frequent main diagnosis in TCPC cases (32.5%). TCPC cases showed
short ventilation times with small interquartile range (median 8 hours), but an elongated
and case variable lengths of hospital stay (median 17 days, 12–24 days, 25 and 75
percentile, respectively).In-hospital mortality is specified in detail in Table
3 . It was 1.6% in isolated surgical and 0.5% in interventional treatments. Cases
with multiple procedures carried the highest mortality of 5.7%. The 336 cases of this
group compounded 48.5% newborns, 25.9% infants, and 25.6% children, adolescents, and
adults. In 27.7% of the cases, patients received not only one but two or more subsequent
procedures, in total 528 procedures including 308 operations and 220 interventions. In the
subgroup analysis of surgical index procedures, the Norwood procedure sticks out with
18.7% mortality. Overall in-hospital mortality rate in all 2.795 interventional cases
(0.5%) is higher compared to defined interventional index procedures (two cases of death
[0.2%] out of 966 cases).
Table 3
In-hospital mortality—all cases and index procedure cases
Note: Interventional index procedures represent 966 out of 2,795 interventions
(35%) and account for 2 out of 15 in-hospital deaths (13%). Surgical index
procedures represent 1,323 out of 2,887 surgical cases (46%) and account for 18
out of 47 in-hospital deaths (38%).
Abbreviations: ASD, atrial septal defect; AVSD, atrioventricular septal defect;
CoA, coarctation aortae; PDA, patent ductus arteriosus; PPVI, percutaneous
pulmonary valve implantation; TCPC, total cavopulmonary connection; TGA,
transposition of great arteries; VSD, ventricular septal defect.Note: Interventional index procedures represent 966 out of 2,795 interventions
(35%) and account for 2 out of 15 in-hospital deaths (13%). Surgical index
procedures represent 1,323 out of 2,887 surgical cases (46%) and account for 18
out of 47 in-hospital deaths (38%).Observed mortality in all five STS-EACTS mortality categories was lower compared with
the published mortality rates from the performance data set of the STS-EACTS group for
2002 to 2007 ( Table 4 ). 6
Table 4
Comparison of observed and expected in-hospital mortality according to
STS-EACTS mortality categories
STS-EACTS mortality category
Numbers (deaths/patients)
Observed mortality (%)
STS-EACTS mortality 2002–2007 a (%)
Category 1
7/1,204
0.6
0.8
Category 2
6/712
0.8
2.6
Category 3
5/396
1.3
5.0
Category 4
11/303
3.6.
9.9
Category 5
12/60
20.0
23.1
Abbreviation: STS-EACTS, Society of Thoracic Surgeons-European Association for
Cardio-Thoracic Surgery.
Observed mortality rates for performance data set in: O'Brien et al. 6
Abbreviation: STS-EACTS, Society of Thoracic Surgeons-European Association for
Cardio-Thoracic Surgery.Observed mortality rates for performance data set in: O'Brien et al. 6Analysis of cases without adverse events is demonstrated in the bar charts of Fig. 2 , focusing on the severity categorization of
recorded adverse events and in the sunburst diagram of Fig. 4 , focusing on the adverse event rates related to the risk categorizations
and the type of intended procedure.
Fig. 4
Case distribution and risk-related outcome for adverse events. This
sunburst diagram analyzes data from a total of 6,018 cases. It visualizes the
distribution of 4,745 cases without complications (79%) and 1,273 cases with adverse
events related to the type of procedure and risk classification. Risk classes 1–5 for
surgery refer to STAT mortality categories and are not comparable to the
interventional procedure-type risk categories 1–4. A case-related risk classification
is not applicable in cases with multiple procedures. Displayed event rates in the
outer circle refer to the particular dedicated risk category. Surgical risk categories
are shown in the right half of the diagram and assorted according to their frequencies
clockwise from top to down. Most surgeries were performed in lower risk categories 1
and 2 with highest freedom of recorded complications in risk category 1 (76%). Lowest
rates of freedom from recorded complications were 52% in risk category 4 and 18% in
risk category 5 (smallest group representing only 60 cases [2%] in the surgical
group). Interventional risk categories are shown in the left half of the diagram and
assorted clockwise from down to top. Most interventions were performed at medium
procedural risk categories 2 and 3. Freedom from recorded complications ranged from
97% in category 1 to 91% in category 4. Cases with multiple procedures showed with a
43% freedom rate of recorded complications a lower score compared with cases with
surgical or interventional treatment. Labeling: Inner circle: cath – interventional
cases; multiple – cases with ≥ 2 procedures at different times; surgery – surgical
cases. Middle circle: r – risk category (1 lowest; 4 5 highest); nc – not classified. Outer circle: no – cases without recorded
complications; event – cases with recorded complications.
Case distribution and risk-related outcome for adverse events. This
sunburst diagram analyzes data from a total of 6,018 cases. It visualizes the
distribution of 4,745 cases without complications (79%) and 1,273 cases with adverse
events related to the type of procedure and risk classification. Risk classes 1–5 for
surgery refer to STAT mortality categories and are not comparable to the
interventional procedure-type risk categories 1–4. A case-related risk classification
is not applicable in cases with multiple procedures. Displayed event rates in the
outer circle refer to the particular dedicated risk category. Surgical risk categories
are shown in the right half of the diagram and assorted according to their frequencies
clockwise from top to down. Most surgeries were performed in lower risk categories 1
and 2 with highest freedom of recorded complications in risk category 1 (76%). Lowest
rates of freedom from recorded complications were 52% in risk category 4 and 18% in
risk category 5 (smallest group representing only 60 cases [2%] in the surgical
group). Interventional risk categories are shown in the left half of the diagram and
assorted clockwise from down to top. Most interventions were performed at medium
procedural risk categories 2 and 3. Freedom from recorded complications ranged from
97% in category 1 to 91% in category 4. Cases with multiple procedures showed with a
43% freedom rate of recorded complications a lower score compared with cases with
surgical or interventional treatment. Labeling: Inner circle: cath – interventional
cases; multiple – cases with ≥ 2 procedures at different times; surgery – surgical
cases. Middle circle: r – risk category (1 lowest; 4 5 highest); nc – not classified. Outer circle: no – cases without recorded
complications; event – cases with recorded complications.The German National Quality Assurance Report on CHD contains detailed age and
risk-related outcome reports on key quality indicators for all combined case groups and
all 15 index procedures, in detail not considered in this overview. These detailed tables
allow each participating center detailed comparison with their own separate and
confidential institution-related report.For interventional cases, observed rates of all adverse events are in similar range as
compared with published data ( Table 5 ). 10 Adverse event rates for surgical cases could not be
compared with published data in this report because defined major events 7 have not been analyzed with respect to STS-EACTS risk
categories (reporting was only on all adverse events) ( Table 6 ).
Table 5
Rate of any adverse event according to procedural risk classification in
interventional cases
Procedural risk category
Numbers (any AE/patients)
Observed rate of any AE a (%)
Expected rate of any AE (%) b
Category 1
7/219
3.2
5.2
Category 2
52/1,265
4.1
13
Category 3
58/686
8.5
19
Category 4
26/295
8.8
25
Abbreviations: AE, adverse event; IPCCC, International Pediatric and Congenital
Cardiac Code.
Any adverse event (AE) as defined for pediatric and congenital interventions—not
to compare with the IPCC code list and the STSCHSD Data collection form for
surgical procedures.
Observed adverse event rates for performance data set in: Bergersen et al. 10
Table 6
Rate of any adverse event according to STS-EACTS mortality categories in
surgical cases
STS-EACTS mortality category
Numbers (any AE/patients)
Observed rate of any AE a (%)
Category 1
288/1,204
23.9
Category 2
235/712
33
Category 3
170/396
42.9
Category 4
145/303
47.9
Category 5
49/60
81.7
Abbreviations: AE, adverse event; IPCCC, International Pediatric and Congenital
Cardiac Code; STS-EACTS, Society of Thoracic Surgeons-European Association for
Cardio-Thoracic Surgery.
Any adverse event (AE) as documented from the IPCC code list. 67.7% of all
adverse events were rated “minor,” 31% were rated “major” according to
complication codes in the STSCHSD Data collection form, Version 2.50, as cited in
Jacobs et al. 7 1.3% of all AE were not
classified.
Abbreviations: AE, adverse event; IPCCC, International Pediatric and Congenital
Cardiac Code.Any adverse event (AE) as defined for pediatric and congenital interventions—not
to compare with the IPCC code list and the STSCHSD Data collection form for
surgical procedures.Observed adverse event rates for performance data set in: Bergersen et al. 10Abbreviations: AE, adverse event; IPCCC, International Pediatric and Congenital
Cardiac Code; STS-EACTS, Society of Thoracic Surgeons-European Association for
Cardio-Thoracic Surgery.Any adverse event (AE) as documented from the IPCC code list. 67.7% of all
adverse events were rated “minor,” 31% were rated “major” according to
complication codes in the STSCHSD Data collection form, Version 2.50, as cited in
Jacobs et al. 7 1.3% of all AE were not
classified.
Longitudinal Data Analysis
Tetralogy of Fallot
The database included 1,632 patients following repair of Fallot over 9 years from 2012
to 2020. Eighteen percent of the patients received palliative procedures prior to
surgical repair. Until the end of 2020 20.8% of the patient's redo procedures were
recorded. The flowchart of Fig. 5 describes
patient's medical career and the bar chart of Fig.
6 visualizes the frequency of redo cases in relation to the time interval after
Fallot repair. The largest number of redo cases and redo procedures took place in the
first year after initial repair. The list of the five most frequent types of operations
comprises delayed closure of sternum and weaning from ECMO indicating complex
postoperative courses ( Fig. 5 ). Patients with
palliative treatment prior to repair were more often subjects of redo procedures (40.3%
vs. 16.5%, respectively).
Fig. 5
Comparison of redo procedures after repair of tetralogy of Fallot with
or without preceding palliation. In this 9-year follow-up observation in patients
after repair of Fallot, the rate of redo procedures was 40.3% compared with 16.5%
after previous palliation.
Fig. 6
Recorded proportion of patients with repeat treatments in relation to
the total number of patients with Fallot correction recorded in this period. This
figure demonstrates the relative probability to require a redo case in relation to
the time after tetralogy of Fallot (TOF) repair. Lower part in each column: patients
with one redo case; above: patients with 2, 3, … up to 5 redo procedures. After
corrective surgery dated from 2012 to 2020, patients have not reached adolescent
age. Note: This is no systematically collected information. Since no data are
available on the completeness of follow-up, these figures must be interpreted as
“minimum proportion.” Redo cases are counted when entered into the registry database
(upper line of the table). The scale basis (lower line of the table) gives the
maximal possible number of patients in the specific time period (patients discharged
after TOF repair). Thus, the probability may be underestimated due to missing cases
or due to overestimation of the basis population.
Comparison of redo procedures after repair of tetralogy of Fallot with
or without preceding palliation. In this 9-year follow-up observation in patients
after repair of Fallot, the rate of redo procedures was 40.3% compared with 16.5%
after previous palliation.Recorded proportion of patients with repeat treatments in relation to
the total number of patients with Fallot correction recorded in this period. This
figure demonstrates the relative probability to require a redo case in relation to
the time after tetralogy of Fallot (TOF) repair. Lower part in each column: patients
with one redo case; above: patients with 2, 3, … up to 5 redo procedures. After
corrective surgery dated from 2012 to 2020, patients have not reached adolescent
age. Note: This is no systematically collected information. Since no data are
available on the completeness of follow-up, these figures must be interpreted as
“minimum proportion.” Redo cases are counted when entered into the registry database
(upper line of the table). The scale basis (lower line of the table) gives the
maximal possible number of patients in the specific time period (patients discharged
after TOF repair). Thus, the probability may be underestimated due to missing cases
or due to overestimation of the basis population.
Coarctation
Over 9 years, from 2012 to 2020, the registry recorded 1,864 patients with primary
treatment of native coarctation. Data from 1,821 patients could be analyzed. Primary
treatment has been transcatheter intervention in 30% and surgery in 70% of the patients.
Native CoA was treated in 786 newborns (43.2%), 455 infants (25.0%), 454 children and
adolescents (24.9%), and 126 adults (6.9%). Types of procedures dispersed in 202 balloon
dilations (10.8%), 353 stent implantations (18.9%), 960 operations without CPB (51.5%),
and 306 operations using CPB (16.4%). The distribution of procedures according to age is
demonstrated in Fig. 7 .
Fig. 7
Distribution of different coarctation of the aorta (CoA) treatment
strategies to age groups. This sunburst diagram shows the distribution of primary
native CoA treatment in 1,864 patients with respect to age and type of treatment.
Frequencies were shown with descend numbers in clockwise direction. Most patients
(43.2%) were treated at newborn age but 126 patients (6.9%) not until adulthood.
Operations without cardiopulmonary bypass (CPB) are most frequent in newborns and
infants while stent procedures dominated treatment in children and adults. Relative
procedure frequencies in the outer circle refer to the particular dedicated age
group.
Distribution of different coarctation of the aorta (CoA) treatment
strategies to age groups. This sunburst diagram shows the distribution of primary
native CoA treatment in 1,864 patients with respect to age and type of treatment.
Frequencies were shown with descend numbers in clockwise direction. Most patients
(43.2%) were treated at newborn age but 126 patients (6.9%) not until adulthood.
Operations without cardiopulmonary bypass (CPB) are most frequent in newborns and
infants while stent procedures dominated treatment in children and adults. Relative
procedure frequencies in the outer circle refer to the particular dedicated age
group.Until the end of 2020, redo procedures in 574 patients (30.8%) were recorded. A total
of 385 (67.1%) of the patients received 1 and 189 (32.9%) ≥ 2 subsequent procedures;
exclusively interventional treatment in 48.8%, exclusively surgery in 31.7%, and both
treatment strategies in 19.5%. The flowchart of Fig.
8 describes patient's medical career and the bar chart of Fig. 9 visualizes the frequency of redo procedures in
relation to the time after primary procedure in native CoA.
Fig. 8
Nine years' follow-up observation in patients with native coarctation
of the aorta. Subsequent procedures during the primary case occurred in 13.4% after
balloon dilations and in 12.7% after cardiopulmonary bypass (CPB) operations. After
discharge from primary care, redo cases with follow-up procedures were frequent in
all treatment arms but more frequent after primary interventional treatment (44.1%
and 35.7% in this 9-year observation period so far).
Fig. 9
Recorded proportion of patients with repeat treatments in relation to
the total number of patients with primary treatment of native coarctation of the
aorta (CoA) recorded in this period. This figure demonstrates the relative
probability of redo cases in relation to the time after primary care of native CoA.
Lower part in each column: patients with one redo case; above: patients with 2 or 3
redo procedures. The majority of redo cases occurred in the first year after primary
treatment and should be interpreted in the context of 43.2% newborn and 25% infant
cases. Probability of redo cases after the first year levels off between 2 and
3%/year. Note: This is no systematically collected information. Since no data are
available on the completeness of follow-up, these figures must be interpreted as
“minimum proportion.” Redo cases were counted when entered into the registry
database (upper line of the table). The scale basis (lower line of the table) gives
the maximal possible number of patients in the specific time period (patients
discharged after primary treatment of native CoA). Thus, the probability may be
underestimated due to missing cases or due to overestimation of
Nine years' follow-up observation in patients with native coarctation
of the aorta. Subsequent procedures during the primary case occurred in 13.4% after
balloon dilations and in 12.7% after cardiopulmonary bypass (CPB) operations. After
discharge from primary care, redo cases with follow-up procedures were frequent in
all treatment arms but more frequent after primary interventional treatment (44.1%
and 35.7% in this 9-year observation period so far).Recorded proportion of patients with repeat treatments in relation to
the total number of patients with primary treatment of native coarctation of the
aorta (CoA) recorded in this period. This figure demonstrates the relative
probability of redo cases in relation to the time after primary care of native CoA.
Lower part in each column: patients with one redo case; above: patients with 2 or 3
redo procedures. The majority of redo cases occurred in the first year after primary
treatment and should be interpreted in the context of 43.2% newborn and 25% infant
cases. Probability of redo cases after the first year levels off between 2 and
3%/year. Note: This is no systematically collected information. Since no data are
available on the completeness of follow-up, these figures must be interpreted as
“minimum proportion.” Redo cases were counted when entered into the registry
database (upper line of the table). The scale basis (lower line of the table) gives
the maximal possible number of patients in the specific time period (patients
discharged after primary treatment of native CoA). Thus, the probability may be
underestimated due to missing cases or due to overestimation of
Discussion
This multicenter registry was initiated by the scientific associations DGTHG and DGPK 1 based on the scientific awareness, that surgical and
interventional treatment of CHD represent complementary parts of common treatment concepts.
11
12 The data of our registry support this thesis. In
2020, one-third to one-half of the cases received interventional or surgical treatment or
even both prior to the actual procedures ( Fig. 2 ).
In 5.6% of all cases, patients received scheduled multiple procedures (mostly combinations
of surgery and intervention). Several CHD diagnoses can be treated either by interventional
or surgical methods. 13
14
15 Detailed analysis of the index procedures (ASD,
VSD, CoA) in the German Report exposes the heart team access in patients with CHD. Surgical
and interventional ASD, VSD, and CoA patients obviously even by age represent a different
spectrum of the diseases ( Table 2 ). The necessity
of evidence-based heart team decisions especially becomes obvious in the long-term
observations ( Figs. 5
6
7
8
9 ). Prerepair palliation in Fallot patients was
performed by various interventional and surgical treatment options. 16
17 Palliated patients obviously represent the more
complex spectrum of CHD with further impact on redo cases and redo procedures after repair
of Fallot—requiring a large variety of interventional and surgical methods. 18 Coarctation patients present themselves at different
age with other symptoms and unlike anatomy of the aortic disease. Though the vast majority
of patients underwent primary treatment of native coarctation in newborn and infant age,
6.9% of the patients in our report received primary treatment in adulthood. 19 While stent procedures dominated in older patients,
surgery was the domain in newborn and infants. However, our data show that balloon dilations
and stent implantations may represent therapeutic options in rare individual patients to
start treatment of coarctation even in newborn and infants. In the future, long-term
assessment will become increasingly more important in CHD since the quality of treatment
frequently does not become apparent within the first months after the procedure. 20
21Combined case group analysis provides a real, live description of the time and effort and
the performance of surgical and interventional treatment in Germany. 22 Cases planned with single interventions required the
least resources. Surgical therapy needed far more intensive care resources and transfusion
medicine. Analysis of subgroups underlines the integrity of our data sets. As expected, the
rates of intensive care treatments, mechanical ventilation, and CPB usage were 100% in some
of the procedures in contrast to the information on native CoA treatment, which was
performed according to different surgical strategies. 20
21 Various planned treatment strategies become
visible by analyzing defined surgical and interventional procedures. Overall, the key
performance indicators ( Table 2 ) mirror the
how-to-do standard in Germany. As an example, the rate of general anesthesia was higher in
ASD interventions, which can be explained by the need for transesophageal echocardiography
guidance. 23 Fluoroscopy times are still an issue in
interventional procedures. 24
25
26 Mean fluoroscopy in most of the index procedures
were below average as well as the in-hospital mortality rates. This may be evidence for an
increasing number of complex interventions underrepresented in the interventional index
procedures.Key quality indicators were the freedom of adverse events and in-hospital mortality rates
( Table 3 , Figs.
3 and 4 ). The overall in-hospital mortality
of all cases was low with 1.6%. 22 When compared
with published data, observed mortality and morbidity in this report ( Tables 3
4
5
6 ) suggest overall good quality of medical
treatment. However, this has to be carefully interpreted with the given limitations of data
acquisition and with respect to the fact that we only report observed mortality and
morbidity and did not compare with calculated expected mortality and morbidity rates. 27
28
29 As expected, mortality was highest after Norwood
I procedures. 30 These patients carried the largest
morbidity burden as well, which was expressed by all key performance indicators ( Table 2 ). Adverse event rates can be related to
increasing risk classification ( Fig. 4 ). As obvious
in Norwood patients, adverse event rates were related to patient's age too. However,
demonstrating this data would have blown up the sunburst diagram in Fig. 4 . It is the nature of complex heart disease that
there is remaining risk for major or catastrophic adverse events ( Fig. 3 ). This was more frequent in surgical cases but
again it has to be emphasized that interventions and operations must not be understood as
competing, but as complementary therapeutic options. Procedural results, process numbers,
and event rates are frequently unsuitable for direct comparison between these treatment
modalities.Completeness, validity, and further developments of this registry will depend on continued
efforts of the DGTHG and the DGPK in close collaboration with all pediatric cardiac and
heart surgical departments in Germany. It will be of outstanding importance to increase
patient safety even further and to ascertain the continued high quality of invasive
procedures for the treatment of CHD.
Limitations
This registry is limited by its all-comers registry design and the voluntary participation
of patients and institutions. Currently, in this report we analyze at least 66% of the
surgical and 62% of the interventional procedures nationwide with larger completeness from
the participating centers. The range of reported lethality in cases with single surgery or
planned multiple procedures compares to anonymous self-disclosure data in the current German
Heart Surgery Report. 9 However, the number of not
reported cases might significantly affect the real postinterventional and postoperative
mortality and morbidity. Though data integrity is monitored before case closure, no source
data monitoring could be performed in this registry so far. This registry does not execute
active follow-up tracking of patients.
Conclusion
Improvement of quality of care requires detailed analysis of risks, performance
indicators, and outcomes. The need of redo cases and redo procedures in patients with
complex CHD underlines the necessity of long-term observations. Reported mortality and
morbidity in this report are comparable to published outcomes. 5
6
Authors: Dylan Thibault; Amelia S Wallace; Marshall L Jacobs; Christoph P Hornik; John M Costello; Gregory F Fleming; Jeffrey P Jacobs; Robert D B Jaquiss; Bryan H Goldstein; Reid C Chamberlain; Kevin D Hill Journal: Circ Cardiovasc Interv Date: 2019-06-04 Impact factor: 6.546
Authors: Andreas Beckmann; Renate Meyer; Jana Lewandowski; Andreas Markewitz; Jan Gummert Journal: Thorac Cardiovasc Surg Date: 2021-06-27 Impact factor: 1.827
Authors: Isabelle Boon; Katrien Vertongen; Bernard P Paelinck; Laurent Demulier; An Van Berendoncks; Catherine De Maeyer; Fabienne Marchau; Joseph Panzer; Kristof Vandekerckhove; Daniel De Wolf Journal: Pediatr Cardiol Date: 2017-09-27 Impact factor: 1.655
Authors: Rodney C G Franklin; Marie J Béland; Steven D Colan; Henry L Walters; Vera D Aiello; Robert H Anderson; Frédérique Bailliard; Jeffrey R Boris; Meryl S Cohen; J William Gaynor; Kristine J Guleserian; Lucile Houyel; Marshall L Jacobs; Amy L Juraszek; Otto N Krogmann; Hiromi Kurosawa; Leo Lopez; Bohdan J Maruszewski; James D St Louis; Stephen P Seslar; Shubhika Srivastava; Giovanni Stellin; Christo I Tchervenkov; Paul M Weinberg; Jeffrey P Jacobs Journal: Cardiol Young Date: 2017-12 Impact factor: 1.093
Authors: Matthew E Oster; Courtney McCracken; Alexander Kiener; Brandon Aylward; Melinda Cory; John Hunting; Lazaros K Kochilas Journal: Am J Cardiol Date: 2019-06-06 Impact factor: 2.778
Authors: Lisa Bergersen; Kimberlee Gauvreau; Audrey Marshall; Jacqueline Kreutzer; Robert Beekman; Russel Hirsch; Susan Foerster; David Balzer; Julie Vincent; William Hellenbrand; Ralf Holzer; John Cheatham; John Moore; James Lock; Kathy Jenkins Journal: Circ Cardiovasc Interv Date: 2011-03-08 Impact factor: 6.546
Authors: David Joseph Harrison; Lauren Shirley; Jennifer Michaud; Jose Rivera; Brian Quinn; Lisa Bergersen; Nicola Maschietto Journal: Am J Cardiol Date: 2021-03-21 Impact factor: 2.778
Authors: Marshall L Jacobs; Sean M O'Brien; Jeffrey P Jacobs; Constantine Mavroudis; Francois Lacour-Gayet; Sara K Pasquali; Karl Welke; Christian Pizarro; Felix Tsai; David R Clarke Journal: J Thorac Cardiovasc Surg Date: 2012-07-24 Impact factor: 5.209
Authors: Andreas Beckmann; S Dittrich; C Arenz; O N Krogmann; A Horke; A Tengler; R Meyer; U M M Bauer; M Hofbeck Journal: Thorac Cardiovasc Surg Date: 2021-02-26 Impact factor: 1.827
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