Abbreviations
ASD:
atrial septal defect
AVC:
Atrioventricular canal
CABG:
coronary artery bypass grafting
CHD:
congenital heart disease
CIED:
Cardiac Implantable Electronic Devices
DLTx:
double lung transplantation
DORV:
double outlet right ventricle
ECC:
extracorporeal circulation
ECLS:
extracorporal life support
ECMO:
extracorporal membrane oxygenation
HLTx:
heart-lung transplantation
HTx:
heart transplantation
ICD:
implantable cardioverter defibrillator
LTx:
lung transplantation
PDA:
patent ductus arteriosus
PTS:
patients
SAVR:
surgical aortic valve replacement
SLTx:
single lung transplantation
TAH:
total artificial heart
TAVI:
transcatheter aortic valve implantation
TGA:
transposition of great arteries
TMLR:
transmyocardial laser revascularization
Tx:
transplantation
VADs:
ventricular assist devices
VSD:
ventricular septal defect
Introduction
Legitimate demands for a sophisticated quality management in medicine—by authorities, scientific organizations, health care companies, and patients all over the world—have stimulated a quality awareness. This resulted in the development of versatile quality assurance activities such as benchmark projects, public reporting, registries, and others to answer those needs. Thirty years ago the board of directors of the German Society for Thoracic and Cardiovascular Surgery (GSTCVS, www.dgthg.de) decided to set up a periodic data collection of all cardiac surgical procedures in terms of a voluntary, unaudited registry.[1]
[2] Since 1989, the data are updated annually, summarized in the sense of a registry, and published in the scientific society journal each year.[3]
[4]
[5]
[6]
[7] The prevalent aims are to detect developments and upcoming trends in cardiac surgery in Germany, to compile various results for nearly all cardiac surgical procedures, to provide each participant with a benchmark of the institutional results to the nationwide achievements, and to facilitate an evaluation on an international level for the German society.
For monitoring actual conditions as well as developments in cardiac medicine, the registry covers all relevant techniques and also innovative technologies including minimally invasive cardiac surgery as well as all kinds of heart valve procedures, including transcatheter heart valve interventions (e.g., TAVI). Thereby, important findings for current patient safety and the future of patient care are collected for evaluation under different aspects.
Data and results presented in this report comprehend the survey of the year 2019.
Materials and Methods
Since 2004, a standardized questionnaire gathers specific information for well-defined procedures, exactly described by an annually updated German adaption of the International Classification of Procedures in Medicine (ICPM) called “operation code” (OPS - Operationen- und Prozedurenschlüssel).
All participating institutions were requested to complete the structured questionnaire by January 20, 2020, entering all performed procedures and associated in-hospital mortality. The recommended path for data export is an electronic transmission of an encrypted file to the society office in Berlin. After transaction, the data were decrypted, evaluated for completeness, and compiled for further analysis, thus ensuring anonymity for each participating institution. This compilation algorithm enables a high compliance for submission of complete datasets.
Inclusion criteria for the registry data 2019 were all cardiac surgical procedures performed on patients between January 1, 2019 and December 31, 2019, unrelated to the date of patients' admission or discharge as compared to other registries. Like in the earlier years, the number of procedures was counted rather than individual patients. For example, if a patient initially required isolated coronary artery bypass grafting (CABG), later followed by a mitral valve reconstruction due to an undesirable event, one count in the category “coronary surgery” and a second one in the category “mitral valve reconstruction” are enumerated. Thus, the registry contains more procedures than the real number of patients operated on.
Death of patients was defined as in-hospital mortality. Per definition, the observed mortality is always attributed to the first cardiac procedure, for example, the death of a patient requiring a replacement of the ascending aorta due to a complication after CABG would only be attributed to the coronary procedure.
The main reason for this structural setup of the registry—established over three decades—is to keep in accordance with the German data privacy act with its specific regulations for patients. Furthermore, it seemed to be relevant to get detailed information about all performed procedures and not only the number of treated patients. Last but not the least the process of data acquisition had to be standardized and feasible for all participating departments in Germany, thus enabling the submission of a complete data set, regardless of the hard- and software used locally.
In 2019, a total of 78 institutions performed heart surgery. As in the years before, all departments answered the questionnaire and delivered a complete data set for the year 2019, including in-hospital mortality rates. In addition, comparisons between the registry data and the external quality assurance in accordance with §§ 135a/136/137 SGB V, obligatory for licensed German hospitals (§ 108 SGB V), are feasible.
For descriptive statistical analyses categorized tables and a summary registry data file consolidate all transmitted information of the 78 departments, providing the basis for this and further publications. Longitudinal data from earlier registry specifications are also included in the presentation. The period considered is restricted to the past 10 years.
Categorical data are displayed as absolute and/or relative frequencies. Due to lack of complete data for patients' risk adjustment, all mortality rates are unadjusted. Quantitative data are presented as absolute frequencies and arithmetic mean values. Where appropriate, the value range is presented additionally. Patient age, though originally a quantitative variable, is only available in age groups and therefore treated as a categorical variable. German population-based measures are calculated as frequencies per 100,000 inhabitants and are based on the latest published data of the Federal Office for Statistics (Destatis) dated December 31, 2018.
The questionnaires were compiled using Microsoft Visual Basic for Applications. Analyses were performed with IBM SPSS Statistics v22 and Microsoft Excel 2010, and charts and tables were created with Microsoft Excel 2010.
Registry Data 2019
[Table 1] shows the distribution of cardiac surgical procedures between the 16 German states, based on the population count of the Federal Office for Statistics as of December 31, 2018. The range of heart operations per 100,000 inhabitants again shows a minimum of 104.2 (Bavaria, population: 13,076,721) and a maximum of 168.7 (Sachsen-Anhalt, population: 2,208,321), while the nationwide mean-value by the end of 2018 was 120.0. Analyzing quantified categories of heart operations by department dimension categorizes nearly 62% of institutions into two clusters with at least 577 up to 1,483 procedures, 29% into those with a minimum of 1,517 up to a maximum of 4,099 performed procedures ([Table 2]). Summarizing the departments by various heart surgical procedures, it can be asserted that heart operations in patients for congenital heart disease (<1 year, with extracorporeal circulation [ECC]) are conducted in 22, isolated heart transplantations in 21, and combined heart-lung transplantations in 4 institutions ([Table 3]).
Table 1
Heart operations/German states
|
Federal state
|
Quantity[a]
|
Population[b]
|
Heart procedures/100,000 inhabitants
|
|
Baden Württemberg
|
11,680
|
11,069,533
|
105.5
|
|
Bayern
|
13,626
|
13,076,721
|
104.2
|
|
Berlin
|
3,973
|
3,644,826
|
109.0
|
|
Brandenburg
|
3,576
|
2,511,917
|
142.4
|
|
Bremen
|
745
|
682,986
|
109.1
|
|
Hamburg
|
2,375
|
1,841,179
|
129.0
|
|
Hessen
|
6,899
|
6,265,809
|
110.1
|
|
Mecklenburg-Vorpommern
|
2,114
|
1,609,675
|
131.3
|
|
Niedersachsen
|
10,238
|
7,982,448
|
128.3
|
|
Nordrhein-Westfalen
|
21,820
|
17,932,651
|
121.7
|
|
Rheinland-Pfalz
|
5,181
|
4,084,844
|
126.8
|
|
Saarland
|
1,318
|
990,509
|
133.1
|
|
Sachsen
|
5,279
|
4,077,937
|
129.5
|
|
Sachsen-Anhalt
|
3,725
|
2,208,321
|
168.7
|
|
Schleswig-Holstein
|
4,088
|
2,896,712
|
141.1
|
|
Thüringen
|
2,975
|
2,143,145
|
138.8
|
|
Germany
|
99,612
|
83,019,213
|
120.0
|
a
n = 834 foreign residents excluded.
b Federal Office for Statistics of German Population due date December 31, 2018.
Table 2
Departments assorted by quantified categories (∑[a] [n = 100,446])
|
Procedures (quantity)
|
<500
|
500–999
|
1,000–1,499
|
1,500–1,999
|
2,000-5,000
|
|
Departments
|
7
|
24
|
12
|
11
|
|
Average
|
372
|
797
|
1,186
|
1,685
|
2,728
|
|
Range
|
237–499
|
577–992
|
1,008–1,483
|
1,517–1,905
|
2,076–4,099
|
a CIED and extracardiac surgery without ECC are excluded.
Table 3
Departments summarized by heart surgery procedures 2019
|
Category
|
n
|
|
Coronary artery bypass grafting
|
77
|
|
Heart valve surgery
|
77
|
|
Pacemaker/ICD procedures
|
76/73
|
|
Surgery for CHD in patient <1 year with ECC
|
22[a]
|
|
Heart transplantation
|
21[b]
|
|
Heart-lung transplantation
|
4
|
a
n = 2099; thereof: 18 operations in 1 unit, 22 to 45 operations in 5 units, 57 to 95 operations in 7 units, 110 to 240 operations in 9 units.
b
n = 333: thereof: 1 to 4 transplants in 8 units, 5 transplants in 3 units, 10 to 18 transplants in 3 units, 21 to 89 transplants in 7 units.
The number of procedures using ECC in Germany from 2010 to 2019 is illustrated in [Table 4]. Over the past decade, the number of heart operations using ECC shows a decline by 12,927 procedures, presumably reflecting an achievement of established innovations like catheter-based procedures in cardiac medicine and minimally invasive therapeutic options in heart surgery, such as off-pump CABG.
Table 4
Cardiac procedures using extracorporeal circulation (2010–2019)
|
2010
|
2011
|
2012
|
2013
|
2014
|
2015
|
2016
|
2017
|
2018
|
2019
|
|
Departments
|
79
|
78
|
79
|
78
|
|
Procedures
|
84,686
|
84,402
|
84,388
|
84,040
|
83,787
|
81,527
|
79,082
|
76,696
|
72,331
|
71,759
|
|
Average
|
1,072
|
1,082
|
1,068
|
1,064
|
1,074
|
1,045
|
1,014
|
983
|
927
|
920
|
Overall, 175,705 procedures were reported to the registry for the year 2019, a difference of <0.5% compared to 2018 (174,902 procedures). In 2019, a total of 100,446 heart surgical procedures in the narrower sense displays an increase of 1.8% (n = 1,739) compared to 2018 (98,707 procedures) ([Table 5]). Concerning gender distribution, the registry shows an overall male/female ratio of 2.0:1 with the greatest difference (3.7:1) in the patient group with coronary procedures ([Table 6]). About 10.8% (n = 10,861) of the operations were conducted as emergency procedures, and 8.4% (n = 8,481) were reoperations ([Table 7]). Sixteen thousand three hundred sixty (44.6%) isolated heart valve procedures were performed as single, 3,206 as double (8.7%), and 355 (1.0%) as triple heart valve procedures ([Table V1]). Three thousand two hundred ninety-three (35.1%) aortic valve and 3,438 (53.6%) mitral valve operations were performed via a minimally invasive access ([Table V2]). In 8,305 (88.4%) isolated aortic valve operations using ECC, xenograft prostheses were implanted, while in 4,140 (64.5%) isolated mitral valve operations a reconstruction with preservation of the native mitral valve could be achieved ([Table V3], [Figs. 1] and [2]). In a total of 3,004 combined mitral valve repair procedures, 1,321 (44.0%) simultaneous CABG procedures, 927 tricuspid valve repairs (30.9%), and 505 (16.8%) aortic valve procedures were performed ([Table V4]). The subgroup of 3,561 multiple heart valve procedures amounted to 2,958 (83.1%) operations, as a combination of mitral + tricuspid (n = 1,600) or mitral + aortic (n = 1,358) valve procedures ([Table V5]). Regarding 15,304 transcatheter aortic valve implantations (TAVI), 13,886 (90.7%) procedures were performed by transvascular and 1,418 (9.3%) by transapical access. In TAVI procedures with the need of ECC, a remarkably high unadjusted mortality rate of 25.9% (n = 81) resp. 23.5% (n = 17) could be observed ([Table V6]), probably related to complications during the initial procedure.
Fig. 1 Selected heart surgical categories (2010–2019). Notes: Congenital heart surgery: ASD repairs in adults or in combination with CABG or heart valve procedures are summarized in the CABG or heart valve procedure groups; Miscellaneous procedures; all other types of procedures with ECC.
Fig. 2 Unadjusted mortality for selected procedures (2010–2019).
Table 5
Frequency of cardiac procedures 2019
|
Category
|
With ECC
|
Without ECC
|
Total
|
Diff. 2018 (%)
|
|
CABG isolated
|
27,147[a]
|
7,077[a]
|
44,093
|
+ 0.6%
|
|
CABG combined
|
9,692[a]
|
177[a]
|
44,093
|
− 4.1%
|
|
Heart valve procedures
|
20,197[a]
|
16,453[a]
|
36,650
|
+ 5.0%
|
|
Surgery of thoracic aorta
|
7,591[a]
|
655[a]
|
8,246
|
+ 0.9%
|
|
Surgery for CHD
|
4,819[a]
|
938[a]
|
5,757
|
− 1.6%
|
|
Cardiac surgery, other
|
1,207[a]
|
1,480[a]
|
2,687
|
+ 14.4%
|
|
Assist device procedures
|
723[a]
|
1,907[a]
|
2,630
|
− 4.8%
|
|
Extracardiac surgery
|
352[a]
|
53,970
|
54,322
|
+ 0.3%
|
|
Pacemaker and ICD procedures
|
31[a]
|
21,289
|
21,320
|
− 5.0%
|
|
Total
|
71,759
|
103,946
|
175,705
|
+ 0.5%
|
a Sum: n = 100,446 (heart surgery procedures).
Table 6
Gender distribution 2019
|
Female
|
Male
|
|
Distribution
|
n
|
%
|
n
|
%
|
|
Heart valve procedures
|
15,656
|
43
|
20,994
|
57
|
|
Coronary procedures
|
9,292
|
21
|
34,801
|
79
|
|
CHD procedures
|
2570
|
45
|
3,187
|
55
|
|
Surgery of thoracic aorta
|
2,804
|
34
|
5,442
|
66
|
|
Cardiac surgery, other
|
1,633
|
61
|
1,054
|
39
|
|
Assist device
|
705
|
27
|
1,925
|
73
|
|
Pacemaker and ICD
|
8,135
|
38
|
13,185
|
62
|
|
Extracardiac surgery
|
18,764
|
35
|
35,558
|
65
|
|
Total
|
59,559
|
38
|
116,146
|
62
|
Table 7
Additional data 2019 versus 2018
|
Procedures with ECC
|
2019
|
2018
|
|
Emergency
|
10,861
|
10.8%
|
11,147
|
11.3 %
|
|
Redo
|
8,481
|
8.4%
|
8,642
|
8.8%
|
Table V1
Isolated heart valve procedures
|
Procedure
|
n
|
†
|
%
|
|
Single valve
|
16,360
|
534
|
3.3
|
|
Double valve
|
3,206
|
318
|
9.9
|
|
Triple valve
|
355
|
58
|
16.3
|
|
Transcatheter access (single valve)
|
16,595
|
400
|
2.4
|
|
Transcatheter access (double valve)
|
30
|
4
|
13.3
|
|
Unspecified
|
104
|
11
|
10.6
|
|
Total
|
36,650
|
1,325
|
3.6
|
Transcatheter heart valve procedures: 15,304 aortic valve implantations; 152 mitral valve implantations; 988 mitral valve repairs.
Seven tricuspid valve implantations; 142 tricuspidal valve repairs; 30 double aortic and mitral valve procedures; 2 pulmonary valve implantations.
Table V2
Single heart valve procedures
|
Access path
|
n
|
†
|
%
|
|
Aortic valve
|
|
Sternotomy
|
6,098
|
215
|
3.5
|
|
Partial sternotomy
|
3,293
|
55
|
1.7
|
|
Transvascular
|
13,886
|
289
|
2.1
|
|
Transapical
|
1,418
|
77
|
5.4
|
|
Mitral valve
|
|
Sternotomy
|
2,981
|
186
|
6.2
|
|
Minimal invasive
|
3,438
|
32
|
0.9
|
|
Transcatheter
|
1,140
|
33
|
2.9
|
|
Tricuspidal valve
|
|
Sternotomy
|
365
|
37
|
10.1
|
|
Minimal invasive
|
125
|
7
|
5.6
|
|
Transcatheter
|
149
|
1
|
0.7
|
|
Pulmonary valve
|
|
Sternotomy
|
55
|
2
|
3.6
|
|
Minimal invasive
|
0
|
–
|
|
Transcatheter
|
2
|
0
|
0.0
|
|
Total
|
32,950
|
934
|
2.8
|
Apical aortic conduits procedures (n = 5) are not included.
Table V3
Isolated aortic/mitral valve operations
|
Prosthesis/native heart valve
|
Aortic
|
Mitral
|
|
n
|
†
|
%
|
n
|
†
|
%
|
|
Xenograft
|
8,305
|
245
|
3.0
|
1,891
|
170
|
9.0
|
|
Mechanical prosthesis
|
908
|
22
|
2.4
|
385
|
16
|
4.2
|
|
Repair
|
158
|
2
|
1.3
|
4,140
|
32
|
0.8
|
|
Homograft
|
20
|
1
|
5.0
|
3
|
0
|
0.0
|
|
Total
|
9,391
|
270
|
2.9
|
6,419
|
218
|
3.4
|
Transcatheter procedures and apical aortic conduits procedures (n = 5) are not included.
Table V4
Isolated/combined mitral valve procedures—implantation/replacement versus repair
|
Mitral valve procedures
|
Repair
|
Implantation/replacement
|
Total
|
|
n
|
†
|
%
|
n
|
†
|
%
|
n
|
% repair
|
†
|
%
|
|
Isolated
|
4,140
|
32
|
0.8
|
2,279
|
186
|
8.2
|
6,419
|
64.5
|
218
|
3.4
|
|
+ CABG
|
1,321
|
82
|
6.2
|
840
|
133
|
15.8
|
2,161
|
61.1
|
215
|
9.9
|
|
+ Tricuspid valve repair[a]
|
927
|
33
|
3.6
|
603
|
74
|
12.3
|
1,530
|
60.6
|
107
|
7.0
|
|
+ Aortic valve
|
505
|
31
|
6.1
|
853
|
136
|
15.9
|
1,358
|
37.2
|
167
|
12.3
|
|
+ CABG + Aortic valve replacement
|
251
|
36
|
14.3
|
274
|
48
|
17.5
|
525
|
47.8
|
84
|
16.0
|
|
Total
|
7,144
|
214
|
3.0
|
4,849
|
577
|
11.9
|
11,993
|
59.6
|
791
|
6.6
|
a Seventy procedures (not specified mitral valve + tricuspid valve surgery) excluded. Mortality: 19% (13/70).
Table V5
Multiple heart valve procedures
|
Combination
|
n
|
†
|
%
|
|
Mitral + tricuspid
|
1,600
|
120
|
7.5
|
|
Aortic + mitral
|
1,358
|
167
|
12.3
|
|
Aortic + mitral + tricuspid
|
354
|
58
|
16.4
|
|
Aortic + tricuspid
|
175
|
27
|
15.4
|
|
Aortic + pulmonary[a]
|
56
|
1
|
1.8
|
|
Tricuspid + pulmonary
|
17
|
3
|
17.6
|
|
Aortic + mitral + pulmonary
|
1
|
0
|
0.0
|
|
Total
|
3,561
|
376
|
10.6
|
Notes: Transcatheter procedures are excluded.
a Including Ross procedures.
Table V6
Transcatheter heart valve procedures
|
Without ECC
|
With ECC
|
Total
|
|
n
|
†
|
n
|
†
|
n
|
†
|
%
|
|
Aortic valve implantation
|
15,206
|
341
|
98
|
25
|
15,304
|
366
|
2.4
|
|
Transvascular
|
13,805
|
268
|
81
|
21
|
13,886
|
289
|
2.1
|
|
Transapical
|
1,401
|
73
|
17
|
4
|
1,418
|
77
|
5.4
|
|
Mitral valve
|
1,069
|
25
|
71
|
8
|
1,140
|
33
|
2.9
|
|
Repair
|
925
|
14
|
63
|
5
|
988
|
19
|
1.9
|
|
Implantation
|
144
|
11
|
8
|
3
|
152
|
14
|
9.2
|
|
Tricuspid valve repair
|
148
|
1
|
0
|
149
|
1
|
0.7
|
|
Repair
|
141
|
1
|
0
|
142
|
1
|
0,7
|
|
Implantation
|
7
|
0
|
7
|
0
|
|
Aortic + mitral valve implantation
|
28
|
3
|
2
|
1
|
30
|
4
|
13.3
|
|
Aortic valve implantation[a] + CABG
|
18
|
1
|
12
|
4
|
30
|
5
|
16.7
|
|
Mitral valve implantation[b] + CABG
|
0
|
2
|
0
|
2
|
0
|
|
Aortic + mitral valve + CABG
|
0
|
–
|
|
Total
|
16,469
|
371
|
186
|
38
|
16,655
|
409
|
2.5
|
Notes: Pulmonary valve implantation for CHD excluded.
9% of TAVI by transapical access and less than 1% of TAVI under ECC conditions.
a Femoral, subclavian, or transaortic access.
b Transvascular and transapical access.
[Tables C1]+[C2], [Con1]+[2], [Mis1]
[2]
[3]
[4]
[5] as well as [Figs. 1]
[2]
[3]
[4]
[5]
[6]
[7]
[8]
[9] to [10] demonstrate further compiled registry data under different aspects and for various categories.
Fig. 3 Age distribution of cardiac procedures (2010–2019). Notes: Patients < 20 years and cardiac implantable electronic device procedures were excluded.
Fig. 4 Isolated coronary artery bypass grafting (2010–2019). CABG, coronary artery bypass grafting.
Fig. 5 Isolated aortic valve (AV) replacement (2010–2019). Notes: Ross procedures, homograft implantations, and transcatheter heart valve interventions excluded.
Fig. 6 Isolated aortic valve replacement and transcatheter aortic valve implantation (TAVI). The annual number of TAVI submitted to this voluntary registry does not represent all TAVI procedures performed in Germany in 2019. +Additional TAVI procedures calculated from the German legal quality assurance program, §§ 135a/ 136/ 137 SGB V.
Fig. 7 Isolated mitral valve surgery (2010–2019).
Fig. 8 Age distribution for congenital heart disease (CHD) (2010–2019). Notes: Bias possible due to the fact that not all relevant procedures can be allocated exactly to CHD-category in patients > 18 years (e.g., aortic valve disease).
Fig. 9 Mechanical circulatory support devices (2010–2019).
Fig. 10 Heart transplantations (2010–2019).
Table C1
Isolated CABG and combined procedures with ECC
|
n
|
†
|
%
|
|
Isolated CABG
|
34,224
|
928
|
2.7
|
|
+ Aortic valve replacement
|
5,289
|
226
|
4.3
|
|
+ Other
|
1,752
|
124
|
7.1
|
|
+ Mitral valve repair
|
1,321
|
82
|
6.2
|
|
+ Mitral valve replacement
|
840
|
133
|
15.8
|
|
+ Aortic valve replacement + mitral valve repair
|
251
|
36
|
14.3
|
|
+ Aortic + mitral valve replacement
|
274
|
48
|
17.5
|
|
+ Aneurysm resection
|
110
|
4
|
3.6
|
|
+ Transcatheter aortic valve implantation
|
30
|
5
|
16.7
|
|
Total
|
44,091
|
1,586
|
3.6
|
Table C2
Isolated CABG with/without ECC
|
Grafts
|
With ECC
|
Without ECC
|
Total
|
|
n
|
†
|
%
|
n
|
†
|
%
|
n
|
†
|
%
|
|
Single
|
955
|
55
|
5.8
|
1,332
|
22
|
1.7
|
2,287
|
77
|
3.4
|
|
Double
|
5,609
|
185
|
3.3
|
1,879
|
32
|
1.7
|
7,488
|
217
|
2.9
|
|
Triple
|
11,740
|
338
|
2.9
|
2,677
|
39
|
1.5
|
14,417
|
377
|
2.6
|
|
Quadruple
|
6,370
|
161
|
2.5
|
968
|
15
|
1.5
|
7,338
|
176
|
2.4
|
|
Quintuple + more
|
2,473
|
81
|
3.3
|
221
|
0
|
0.0
|
2,694
|
81
|
3.0
|
|
Total
|
27,147
|
820
|
3.0
|
7,077
|
108
|
1.5
|
34,224
|
928
|
2.7
|
Table Con1
Congenital heart surgery with/without ECC
|
Age (years)
|
n
|
†
|
%
|
|
With ECC
|
Without ECC
|
With ECC
|
Without ECC
|
With ECC
|
Without ECC
|
|
< 1
|
2,121
|
744
|
81
|
25
|
3.8
|
3.4
|
|
1–17
|
1,806
|
179
|
15
|
1
|
0.8
|
0.6
|
|
≥ 18
|
969
|
15
|
34
|
1
|
3.5
|
6.7
|
|
Total
|
4,896
|
938
|
130
|
27
|
2.7
|
2.9
|
Table Con2
Procedures for congenital heart disease with and without ECC
|
Lesion/Procedure
|
Age < 1 year
|
Age 1–17 years
|
Age ≥ 18 year
|
|
n
|
†
|
%
|
n
|
†
|
%
|
n
|
†
|
%
|
|
ASD
|
47
|
0
|
0.0
|
291
|
0
|
0.0
|
244
|
6
|
2.5
|
|
Complete AV canal
|
200
|
4
|
2.0
|
89
|
4
|
4.5
|
10
|
0
|
0.0
|
|
VSD
|
331
|
2
|
0.6
|
133
|
0
|
0.0
|
15
|
0
|
0.0
|
|
Fallot's tetralogy
|
180
|
0
|
0.0
|
42
|
0
|
0.0
|
2
|
0
|
0.0
|
|
DORV
|
68
|
3
|
4.4
|
14
|
2
|
14.3
|
0
|
–
|
|
TGA
|
157
|
5
|
3.2
|
3
|
0
|
0.0
|
0
|
–
|
|
TGA + VSD
|
62
|
0
|
0.0
|
9
|
0
|
0.0
|
0
|
–
|
|
Truncus arteriosus
|
29
|
3
|
10.3
|
5
|
0
|
0.0
|
0
|
–
|
|
Fontan circulation
|
0
|
–
|
231
|
1
|
0.4
|
4
|
0
|
0.0
|
|
Norwood
|
153
|
26
|
17.0
|
1
|
0
|
0.0
|
0
|
–
|
|
Pulmonary valve
|
62
|
1
|
1.6
|
210
|
0
|
0.0
|
67
|
2
|
3.0
|
|
Transcatheter pulmonary valve implantation
|
0
|
–
|
0
|
–
|
2
|
0
|
0.0
|
|
Aortic valve
|
50
|
2
|
4.0
|
224
|
3
|
1.3
|
370
|
12
|
3.2
|
|
Ross procedure
|
8
|
4
|
50.0
|
24
|
0
|
0.0
|
52
|
0
|
0.0
|
|
Mitral valve
|
39
|
1
|
2.6
|
93
|
0
|
0.0
|
92
|
7
|
7.6
|
|
Tricuspid valve
|
81
|
6
|
7.4
|
56
|
2
|
3.6
|
40
|
4
|
10.0
|
|
PDA
|
191
|
6
|
3.1
|
26
|
0
|
0.0
|
1
|
0
|
0.0
|
|
Coarctation
|
199
|
2
|
1.0
|
30
|
0
|
0.0
|
0
|
–
|
|
Others
|
1,001
|
41
|
4.1
|
461
|
4
|
0.9
|
85
|
4
|
4.7
|
|
HTx
|
7
|
0
|
0.0
|
37
|
0
|
0.0
|
0
|
–
|
|
HLTx
|
0
|
–
|
0
|
–
|
0
|
–
|
|
LTx
|
0
|
–
|
6
|
0
|
0.0
|
0
|
–
|
|
Total
|
2,865
|
106
|
3.7
|
1,985
|
16
|
0.8
|
984
|
35
|
3.6
|
Table Mis1
Ross procedures (autologous AV- and PVR)
|
Age (years)
|
2010
|
2011
|
2012
|
2013
|
2014
|
2015
|
2016
|
2017
|
2018
|
2019
|
|
< 18
|
43
|
40
|
36
|
33
|
37
|
28
|
38
|
29
|
32
|
|
≥ 18
|
184
|
134
|
117
|
107
|
90
|
64
|
72
|
52
|
61
|
104
|
|
Total
|
227
|
174
|
153
|
140
|
127
|
92
|
110
|
90
|
136
|
Table Mis2
Heart and lung transplantation
|
Transplant
|
With ECC
|
Without ECC
|
|
n
|
†
|
%
|
n
|
†
|
%
|
|
HTx
|
333
|
33
|
9.9
|
|
|
HLTx
|
6
|
2
|
33.3
|
|
|
LTx
|
42
|
4
|
9.5
|
269
|
11
|
4.1
|
Notes: All pediatric transplantations (demonstrated in table Con2) are included.
Eurotransplant (ET) report 2019: 333 HTx, 4 HTx + kidneyTx, 1 HTx + liverTx, 6 HLTx, 327 DLTx, 26 SLTx, 0 LTx + kidneyTx and 2 LTx + liverTx.
Table Mis3
Aortic surgery
|
Replacement [a]
|
With ECC
|
Without ECC
|
|
n
|
†
|
%
|
n
|
†
|
%
|
|
Supracoronary replacement of ascending aorta
|
1,377
|
116
|
8.4
|
|
|
|
|
Supracoronary ascending + aortic valve replacement
|
1,372
|
58
|
4.2
|
|
|
|
|
Infracoronary replacement of ascending aorta
|
|
|
–
|
|
|
|
|
Mechanical aortic valve conduits
|
349
|
16
|
4.6
|
|
|
|
|
Biological aortic conduits
|
1,034
|
120
|
11.6
|
|
|
|
|
David procedure
|
479
|
9
|
1.9
|
|
|
|
|
Yacoub procedure
|
111
|
5
|
4.5
|
|
|
|
|
Other
|
345
|
31
|
9.0
|
|
|
|
|
Aortic arch replacement[b]
|
2,398
|
316
|
13.2
|
|
|
|
|
Replacement of descending aorta
|
51
|
6
|
11.8
|
3
|
1
|
33.3
|
|
Thoracoabdominal aortic replacement
|
75
|
14
|
18.7
|
11
|
1
|
9.1
|
|
Endostent descending aorta
|
0
|
0
|
–
|
641
|
32
|
5.0
|
|
Total
|
7,591
|
691
|
9.1
|
655
|
34
|
5.2
|
Notes: All procedures involving aortic surgery are included in this table. Isolated aortic surgery as well as all possible combined procedures (e.g., additional CABG) are summarized in this category.
a Procedures for abdominal aortic diseases excluded: 424, abdominal procedures and 27 endovascular abdominal stents.
b All possible combined procedures included; the only common denominator is aortic arch surgery.
Table Mis4
Pacemaker and ICD procedures
|
Device/Category
|
|
With ECC
|
Without ECC
|
|
n
|
†
|
%
|
n
|
†
|
n
|
†
|
|
Pacemaker
|
12,952
|
101
|
0.8
|
11
|
3
|
12,941
|
98
|
|
Implantation
|
8,722
|
60
|
0.7
|
1
|
0
|
8,721
|
60
|
|
Battery exchange
|
1,682
|
1
|
0.1
|
1
|
0
|
1,681
|
1
|
|
Revision procedures
|
2,548
|
40
|
1.6
|
9
|
3
|
2,539
|
37
|
|
ICD
|
6,864
|
71
|
1.0
|
18
|
2
|
6,846
|
69
|
|
Implantation
|
2,933
|
16
|
0.5
|
4
|
0
|
2,929
|
16
|
|
Battery exchange
|
1,569
|
2
|
0.1
|
0
|
1,569
|
2
|
|
Revision procedures
|
2,362
|
53
|
2.2
|
14
|
2
|
2,348
|
51
|
|
Miscellaneous
|
1,504
|
19
|
1.3
|
2
|
0
|
1,502
|
19
|
|
Total
|
21,320
|
191
|
0.9
|
31
|
5
|
21,289
|
186
|
Table Mis5
Surgical procedures for treatment of tachyarrhythmias
|
Energy source
|
Endocardiac
|
Epicardiac
|
Total
|
|
n
|
n
|
|
Unipolar radio frequency
|
97
|
181
|
278
|
|
Unipolar cooled radio frequency
|
73
|
141
|
214
|
|
Bipolar radio frequency
|
262
|
1,857
|
2,119
|
|
Cryothermy
|
1,388
|
401
|
1,789
|
|
Microwave
|
0
|
15
|
|
Focused ultrasound
|
6
|
118
|
124
|
|
Laser
|
0
|
|
Other
|
10
|
0
|
10
|
|
Total
|
1,836
|
2,713
|
4,549
|
Note: 361 procedures are unspecified with regard to endocardiac/epicardiac ablation.
Compared to the data of previous years, several important developments remained almost unchanged in 2019. The age distribution of patients ([Fig. 5]) shows a continuous shift towards an elderly patient population. Presently, 33.5% of the cardiac procedures are performed in patients from 70 to 79 years of age, and 18.6% in octo-/nonagenarians. However, unadjusted mortality rates just show a discrete change over the last decade ([Fig. 4]). The number of CABG procedures, isolated or combined, decreased over the past decade, while the relative number of isolated off-pump CABG remains on a nearly unchanged level of 20.7% compared to the previous year (2018: 20.6%) ([Figs. 3], [6]).
There is still a continuous increase in transcatheter heart valve procedures in Germany with a total of 16,469 procedures in 2019 ([Table V6]). For the last year 15,304 (62.4%) TAVI and 9,233 (37.6%) surgical aortic valve replacement procedures were reported to the registry ([Fig. 7]). It must be emphasized that exclusively the German departments for cardiac surgery contribute these data. Therefore, the registry cannot reach completeness because procedures documented by cardiology departments are missed. On the basis of and in addition to the recommendations of international scientific guidelines resp. expert consensus on the management of valvular heart disease,[8]
[9]
[10]
[11] the German Federal Joint Committee (G-BA) implemented a quality assurance directive for “minimally invasive heart valve interventions (TAVI, transcatheter mitral clip reconstruction)” in July 2015. In this obligatory structures, defined processes, and qualified personnel are precisely specified.[12] Further surveys for selected procedures, such as the legally compulsory quality assurance (§135a SGB V) or the voluntary nationwide German Aortic Valve Registry (GARY),[13]
[14]
[15]
[16]
[17]
[18]
[19]
[20] provide various important findings and thus also contribute to an exceptional patient benefit.
In 2019, the rate of isolated mitral valve reconstructions remains almost unchanged on a remarkable level of 64.5% (2018: 64.3%) ([Fig. 2]). Based on the fact that each isolated mitral valve procedure is included, regardless of the underlying mitral valve disease concerning morphology or urgency of operation, it can be assumed that the relative rate of mitral valve reconstruction would certainly be even higher if patients without a possibility or indication for reconstruction would have been excluded (e.g., mitral valve stenosis, calcifications, or endocarditis). In other publications, for example, Gammie et al,[21] patients with mitral valve stenosis, endocarditis, and emergency procedures are usually excluded. Therefore, other published rates of mitral valve repair have to be interpreted with caution if compared to this registry.
In 2019, the ventricular assist device (L-/ R-/ BVAD, TAH) implantations (n = 953) showed a slight increase of 1.2% compared to 2018 (n = 942) ([Fig. 9]), while the heart transplantations (n = 333) reached a new height for the past 5 years ([Fig. 10]). Nevertheless, the mechanical circulatory support therapy, in particular left ventricular assist device, is still of outstanding importance for patients with end-stage heart failure.
Discussion
The registry of the GSTCVS enables a comprehensive overview of all heart surgical procedures performed in Germany in 2019. The accuracy of this registry is considered to be high due to the implemented compilation algorithm using standardized operation coding as a relevant criterion for reimbursement purposes. This is supported by other authors who could demonstrate a high accuracy for major outcome parameters in unaudited registries.[22] As observed in recent years, heart surgery in Germany is continuously performed on a high level with superior in-hospital patient survival compared to international surveys. In addition, the registry demonstrates that the provision of cardiac surgery in Germany is appropriate, and that patient care is guaranteed nationwide at all times (24/7/365). These aspects are especially important in the context of various activities in health care policy and considering the background of demographic trends of the German population, leading to patients at increased age combined with related comorbidities and an accordingly complex perioperative risk profile.
Compared to 2018, the number of cardiac surgery procedures showed a slight decrease for isolated + combined coronary artery bypass procedures, an ongoing trend in view of the German population characteristics and in the context of application of the scientific guidelines.[23]
[24] Otherwise, the renewed increase in heart transplantations is a reason for hope that this positive development will continue.
Further improvements in the registry are recommended to enable more specified assessments and particularly risk-adjusted data analyses. However, if significant fundamental changes related to the modality of data collection were to be implemented, a modified structure would have to ensure further longitudinal data analysis.
Completeness, validity, and further progress depend on continued efforts and a close collaboration of the GSTCVS and all cardiac surgical departments in Germany. This will be of outstanding importance as a contribution for patient safety and to obtain evidence for the high quality of heart surgery in Germany.
