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. More than 30 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 scientific
registry, and published in the 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 in comparison
to the nationwide achievements; and to facilitate an evaluation on an international
level for the GSTCVS.
For monitoring actual conditions as well as developments in cardiac medicine, the
registry covers all relevant techniques and also innovative technologies incl. minimally
invasive cardiac surgery as well as all kinds of heart valve procedures, incl. 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 presented in this report comprehend the survey of the year 2021 whereby more
than special circumstances, caused by the further ongoing COVID-19 pandemic, must
necessarily be taken into account when interpreting the results.
Material 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 called “operation code” (OPS: Operationen-
und Prozedurenschlüssel).
All participating institutions were requested to complete the structured questionnaire
by January 25, 2022, 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 2021 were all cardiac surgical procedures
performed on patients from January 1 to December 31, 2021, 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, e.g. the death of a
patient requiring a replacement of ascending aorta due to complication after CABG
would only be attributed to coronary procedure.
The main reason for this structural set-up of the registry – established over four
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. Finally
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 hardware and software used locally.
In 2021, 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
surgical details, including unadjusted 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 possible.
Due to unexpected technical problems very little data concerning some patients' origins
were not available for the year 2021.
For descriptive statistical analyses categorized tables and a summary registry data
file consolidate the transmitted information of all departments, providing the basis
for this and further publications. Longitudinal data from earlier registry specifications
are also included in the presentation. The period considered where developments are
shown 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 September 30, 2021.
The questionnaires were compiled using Microsoft Visual Basic for Applications. Analyses
were performed with IBM SPSS Statistics v22 and Microsoft Excel 2010, charts and tables
were created with Microsoft Excel 2010.
Registry Data 2021
[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 September
30, 2021. Concerning patients' origin it has to be considered that a very small amount
of missing data (0.9%) influences the distribution of heart procedures per federal
state. Taking this into account, the range of heart operations per 100,000 inhabitants
shows a minimum of 96.3 (Baden-Württemberg, population: 11,123,393) and a maximum
of 156.1 (Sachsen-Anhalt, population: 2,172,221), while the nationwide mean-value
at the end of 2021 was 109.9 ([Table 1]). In addition, [Table 1] shows a state-by-state representation of confirmed COVID-19 cases/100,000 population
with a median of 5,483.9 (range: 9,594), a minimum of 3,174 in Schleswig-Holstein
and a maximum of 12,768 in Sachsen. Thus, the mean of confirmed COVID-19 cases was
threefold higher than last year's and a much broader range among the federal states
(range 2020: 2,504) could be observed.
Table 1
German states/Heart operations/confirmed COVID-19 cases
|
Federal state
|
Population[a]
|
Quantity[b]
|
Heart procedures/100,000 inhabitants
|
Total number of COVID-19 cases[c]
|
COVID-19 cases/100,000 population[c]
|
|
Baden-Württemberg
|
11,123,393
|
10,716
|
96.3
|
774,223
|
6,960
|
|
Bayern
|
13,176,644
|
13,051
|
99.0
|
998,071
|
7,575
|
|
Berlin
|
3,669,811
|
3,704
|
100.9
|
230,966
|
6,294
|
|
Brandenburg
|
2,537,202
|
3,152
|
124.2
|
200,301
|
7,895
|
|
Bremen
|
675,171
|
685
|
101.5
|
33,606
|
4,977
|
|
Hamburg
|
1,853,049
|
2,186
|
118.0
|
101,845
|
5,496
|
|
Hessen
|
6,290,030
|
7,036
|
111.9
|
340,702
|
5,417
|
|
Mecklenburg-Vorpommern
|
1,612,466
|
1,228
|
76.2
|
87,764
|
5,443
|
|
Niedersachsen
|
8,025,848
|
9,479
|
118.1
|
333,592
|
4,156
|
|
Nordrhein-Westfalen
|
17,918,037
|
19,939
|
111.3
|
979,527
|
5,467
|
|
Rheinland-Pfalz
|
4,105,944
|
4,636
|
112.9
|
205,203
|
4,998
|
|
Saarland
|
983,070
|
1,034
|
105.2
|
53,790
|
5,472
|
|
Sachsen
|
4,046,699
|
4,860
|
120.1
|
516,664
|
12,768
|
|
Sachsen-Anhalt
|
2,172,221
|
3,391
|
156.1
|
194,547
|
8,956
|
|
Schleswig-Holstein
|
2,920,850
|
3,875
|
132.7
|
92,704
|
3,174
|
|
Thüringen
|
2,112,007
|
2,509
|
118.8
|
245,940
|
11,645
|
|
Deutschland
|
83,222,442
|
91,481
|
109.9
|
5,389,445
|
6,476
|
a Federal Office for Statistics of German Population; due date September 30st 2021.
b
n = 529, foreign residences excluded.
c Robert Koch Institute: laboratory confirmed COVID-19 cases; due date December 30st, 2021.
Analyzing quantified categories of heart operations by department dimension, categorizes
more than 66.7% of institutions into two clusters with 500 up to 1,499 procedures
(2021: 52/78) and 21.8% into those with a minimum of 1,500 up to a maximum of 4,040
performed procedures, respectively ([Table 2]). Before the pandemic started in January 2020 the caseload of the heart surgery
departments was considerably higher.
Table 2
Departments assorted by quantified categories (∑[a] [n = 92,838])
|
Procedures (quantity)
|
<500
|
500–999
|
1,000–1,499
|
1,500–1,999
|
2,000–5,000
|
|
Departments
|
9
|
32
|
20
|
6
|
11
|
|
Average
|
373
|
795
|
1,241
|
1,708
|
2,635
|
|
Range
|
157–491
|
551–975
|
1,036–1,493
|
1,565–1,982
|
2,057–4040
|
a CIED and extracardiac surgery without ECC are excluded.
Summarizing the departments by various heart surgical procedures, it can be asserted
that heart operations in patients suffering from congenital heart disease or CHD (<1
year, with extracorporeal circulation [ECC]) are conducted in 21, isolated heart transplantations
in 19 and combined heart–lung transplantations in one institution ([Table 3]).
Table 3
Departments summarized by heart surgery procedures 2021
|
Category
|
n
|
|
Coronary artery bypass grafting
|
77
|
|
Heart valve surgery
|
77
|
|
Pacemaker/ICD procedures
|
75/74
|
|
Surgery for CHD (pat, <1 y with ECC)
|
21[a]
|
|
Heart transplantation
|
19[b]
|
|
Heart-lung transplantation
|
1
|
a
N = 2,061: thereof: 19–40 op. in three units, 50–85 op. in nine units, 109–207 op.
in nine units.
b
N = 329: thereof: 1–4 transpl. in five units, 5–9 transpl. in four units, 10–19 transpl.
in five units, 33–63 transpl. in five units.
Overall, as shown in [Table 4], 161,261 procedures were reported to the registry for the year 2021, a difference
of 0.3% compared to 2020 (161,817 procedures) but a remarkable decline to 2019 (175,705
procedures). In 2021 the total amount of 92,838 heart surgical procedures in the narrower
sense remained almost unchanged to the previous year (92,809 procedures) while from
2020 to 2019 a COVID-19 influenced decrease of 7.6% (100.446 procedures) was seen.
Regarding CABG procedures an ongoing decrease must be recorded while heart valve and
thoracic aorta procedures increased. The remarkable increase of assist device procedures
by 12.5% is caused by a rise of non-permanent systems, almost certainly an effect
of the COVID-19 pandemic ([Table 4]).
Table 4
Frequency of cardiac procedures 2021
|
Category
|
With ECC
|
Without ECC
|
Total
|
Diff, 2020 (%)
|
|
CABG isolated
|
21,280[a]
|
6,667[a]
|
27,947
|
−5.1%
|
|
CABG combined
|
7,961[a]
|
214[a]
|
8,175
|
−4.3%
|
|
Heart valve procedures
|
17,665[a]
|
19,049[a]
|
36,714
|
+ 3.5%
|
|
Surgery of thoracic aorta
|
7,499[a]
|
704[a]
|
8,203
|
+ 4.7%
|
|
Surgery for CHD
|
4,645[a]
|
890[a]
|
5,535
|
−0.6%
|
|
Cardiac surgery, other
|
1,322[a]
|
1,210[a]
|
2,532
|
+ 0.1%
|
|
Assist device procedures
|
578[a]
|
2,832[a]
|
3,410
|
+12.5%
|
|
Extracardiac surgery
|
287[a]
|
48,968
|
49,255
|
+0.2%
|
|
Pacemaker and ICD procedures
|
35[a]
|
19,455
|
19,490
|
−3.7%
|
|
Total
|
61,272
|
99,989
|
161,261
|
−0.3%
|
a Sum: n = 92,838 (heart surgery procedures).
The number of procedures using ECC in Germany from 2012 to 2021 are illustrated in
[Table 5]. Since 2012, a gradual reduction can be observed with the strongest decline in 2020.
Presumably this reflects on one hand achievements of established innovations with
minimally invasive heart surgical procedures, and on the other hand a relevant effect
of the COVID-19 pandemic since 2020. In addition, the comparison of 2020 and 2021
shows a further decrease of 2,448 cardiac procedures using ECC during the ongoing
pandemic situation.
Table 5
Cardiac procedures using extracorporeal circulation (2012–2021)
|
2012
|
2013
|
2014
|
2015
|
2016
|
2017
|
2018
|
2019
|
2020
|
2021
|
|
Departments
|
79
|
79
|
78
|
78
|
78
|
78
|
78
|
78
|
78
|
78
|
|
Operations
|
84,388
|
84,040
|
83,787
|
81,527
|
79,082
|
76,696
|
72,331
|
71,759
|
63,720
|
61,272
|
|
Average
|
1,068
|
1,064
|
1,074
|
1,045
|
1,014
|
983
|
927
|
920
|
817
|
786
|
Concerning gender distribution, the registry shows an overall male/female ratio of
almost 2:1 with the greatest difference (4:1) in the patient group with coronary procedures
([Table 6]). 10,560 (11.4%) operations were conducted as emergency procedures, and 6,783 (7.3%)
were reoperations ([Table 7]). These proportions appear quite consistent over the past years.
Table 6
Gender distribution
|
Distribution
|
Female
|
Male
|
|
n
|
%
|
n
|
%
|
|
Heart valve procedures
|
15,523
|
42
|
21,191
|
58
|
|
Coronary procedures
|
7,592
|
21
|
28,530
|
79
|
|
CHD procedures
|
2,491
|
45
|
3,044
|
55
|
|
Surgery of thoracic aorta
|
2,746
|
33
|
5,457
|
67
|
|
Cardiac surgery, other
|
1,525
|
60
|
1,007
|
40
|
|
Assist device
|
885
|
26
|
2,525
|
74
|
|
Pacemaker and ICD
|
7,073
|
36
|
12,417
|
64
|
|
Extracardiac surgery
|
17,375
|
35
|
31,880
|
65
|
|
Total
|
55,210
|
34
|
106,051
|
66
|
Table 7
Additional data 2020 vs. 2019
|
Procedures with ECC
|
2021
|
2020
|
|
Emergency
|
10,560
|
11.4%
|
10,445
|
11.3%
|
|
Redo
|
6,783
|
7.3%
|
7,330
|
7.9%
|
As shown in [Table V1] 14,279 (38.9%) isolated heart valve procedures were performed as single, 2,792 as
double (7.6%), and 323 (0.9%) as triple valve procedures. Further 2,834 (36.8%, n = 7,698) aortic valve and 3,369 (55.7%, n = 6,052) mitral valve operations were performed via a minimally invasive access ([Table V2]). The number of single heart valve procedures via transcatheter approach increased
over the last 2 years concerning aortic, mitral and tricuspid valve. The unadjusted
mortality of the surgical aortic valve procedures amounts to 2.9%, nearly consistent
over the last 3 years. Concerning the transcatheter aortic valve implantations (TAVI),
transferred by all heart surgery departments in Germany, the unadjusted mortality
rate was 1.9% in 2021, a decrease of 0.5 percentage points compared to the two previous
years (2020/2019: 2.4%).
Table V1
Isolated heart valve procedures
|
Procedure
|
N
|
†
|
%
|
|
Single valve
|
14,279
|
500
|
3.5
|
|
Double valve
|
2,792
|
259
|
9.3
|
|
Triple valve
|
323
|
51
|
15.8
|
|
Transcatheter access (single valve)
|
19,203
|
380
|
2.0
|
|
Transcatheter access (double valve)
|
39
|
3
|
7.7
|
|
Unspecified
|
78
|
5
|
6.4
|
|
Total
|
36,714
|
1,198
|
3.3
|
Notes: Transcatheter heart valve procedures: 16,903 aortic valve implantation; 230
mitral valve implantation; 1,542 mitral valve repair; six tricuspid valve implantation;
522 tricuspid valve repair; 39 double aortic and mitral valve procedure.
Table V2
Single heart valve procedures
|
Access path
|
N
|
†
|
%
|
|
Aortic valve
|
|
|
|
|
Sternotomy
|
4,864
|
188
|
3.9
|
|
Partial sternotomy
|
2,834
|
38
|
1.3
|
|
Transvascular
|
15,992
|
275
|
1.7
|
|
Transapical
|
911
|
47
|
5.2
|
|
Mitral valve
|
|
|
|
|
Sternotomy
|
2,683
|
202
|
7.5
|
|
Minimal invasive
|
3,369
|
33
|
1.0
|
|
Transcatheter
|
1,772
|
52
|
2.9
|
|
Tricuspid valve
|
|
|
|
|
Sternotomy
|
346
|
28
|
8.1
|
|
Minimal invasive
|
127
|
10
|
7.9
|
|
Transcatheter
|
528
|
6
|
1.1
|
|
Pulmonary valve
|
|
|
|
|
Sternotomy
|
55
|
1
|
1.8
|
|
Minimal invasive
|
0
|
0
|
–
|
|
Transcatheter
|
0
|
0
|
–
|
|
Total
|
33,481
|
880
|
2.6
|
Note: Apical aortic conduits procedures (n = 1) are not included,
In 6,754 (87.7%) isolated aortic valve operations under ECC conditions, xenograft
prostheses were implanted, a consistent distribution over the last 5 years ([Table V3], [Fig. 5]). Concerning the treatment of mitral valve disease, in 63.3% (3,828) of the isolated
mitral valve operations a reconstruction with preservation of the native valve could
be achieved ([Fig. 7]). In a total of 2,500 combined mitral valve repair procedures, 1,094 (43.8%) simultaneous
CABG procedures, 765 tricuspid valve repairs (30.6%), 464 (18.6%) aortic valve procedures
and 177 (7.1%) concomitant CABG and AVR were performed ([Table V4]).
Table V3
Isolated aortic/mitral valve operations
|
Prosthesis/native heart valve
|
Aortic
|
Mitral
|
|
n
|
†
|
%
|
n
|
†
|
%
|
|
Xenograft
|
6,754
|
209
|
3.1
|
1,798
|
168
|
9.3
|
|
Mechanical prosthesis
|
748
|
13
|
1.7
|
422
|
19
|
4.5
|
|
Repair
|
175
|
4
|
2.3
|
3,828
|
48
|
1.3
|
|
Homograft
|
21
|
0
|
0.0
|
4
|
0
|
0.0
|
|
Total
|
7,698
|
226
|
2.9
|
6,052
|
235
|
3.9
|
Note: Transcatheter procedures and apical aortic conduits procedures (n = 1) are not included.
Table V4
Isolated/combined mitral valve procedures—implantation/replacement vs. repair
|
Mitral valve procedures
|
Repair
|
Implantation/replacement
|
Total
|
|
n
|
†
|
%
|
N
|
†
|
%
|
n
|
†
|
%
|
|
Isolated
|
3,828
|
48
|
1.3
|
2,224
|
187
|
8.4
|
6,052
|
235
|
3.9
|
|
+ CABG
|
1,094
|
46
|
4.2
|
802
|
130
|
16.2
|
1,896
|
176
|
9.3
|
|
+ Tricuspid valve repair[a]
|
765
|
22
|
2.9
|
492
|
63
|
12.8
|
1,257
|
85
|
6.8
|
|
+ Aortic valve
|
464
|
27
|
5.8
|
786
|
120
|
15.3
|
1,250
|
147
|
11.8
|
|
+ CABG + Aortic valve replacement
|
177
|
19
|
10.7
|
245
|
53
|
21.6
|
422
|
72
|
17.1
|
|
Total
|
6,328
|
162
|
2.6
|
4,549
|
553
|
12.2
|
10,877
|
715
|
6.6
|
a 39 procedures (not specified mitral valve + tricuspid valve surgery) excluded. Mortality:
15% (6/39).
The subgroup of 3,115 multiple heart valve procedures amounted to 2,546 (81.7%) double
heart valve operations as a combination of mitral + tricuspid (n = 1,296) or mitral + aortic (n = 1,250) valve procedures ([Table V5]). Regarding the 16,903 transcatheter aortic valve implantations (TAVIs), an increase
to 15,992 (94.6%) procedures performed by transvascular access and a lasting decrease
to 911 (5.4%) by transapical access could be observed. In TAVI procedures without
ECC the unadjusted mortality for those by transvascular access improved to 1.6% (255/15.917),
respectively 4.9% (44/901) for the transapical approach. On the other hand, TAVI under
use of ECC shows a remarkably high unadjusted mortality rate of 26.7% (20/75), respectively
30.0% (3/10) ([Table V6]), probably related to complications during the initial procedure.
Table V5
Multiple heart valve procedures
|
Combination
|
N
|
†
|
%
|
|
Mitral + tricuspid
|
1,296
|
91
|
7.0
|
|
Aortic + mitral
|
1,250
|
147
|
11.8
|
|
Aortic + mitral + tricuspid
|
320
|
51
|
15.9
|
|
Aortic + tricuspid
|
133
|
19
|
14.3
|
|
Aortic + pulmonary[a]
|
102
|
2
|
2.0
|
|
Tricuspid + pulmonary
|
11
|
0
|
0.0
|
|
Aortic + mitral + pulmonary
|
3
|
0
|
0.0
|
|
Total
|
3,115
|
310
|
10.0
|
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
|
16,818
|
299
|
85
|
23
|
16,903
|
322
|
1.9
|
|
Transvascular
|
15,917
|
255
|
75
|
20
|
15,992
|
275
|
1.7
|
|
Transapical
|
901
|
44
|
10
|
3
|
911
|
47
|
5.2
|
|
Mitral valve
|
1,666
|
40
|
106
|
12
|
1,772
|
52
|
2.9
|
|
Repair
|
1,448
|
27
|
94
|
4
|
1,542
|
31
|
2.0
|
|
Implantation
|
218
|
13
|
12
|
8
|
230
|
21
|
9.1
|
|
Tricuspid valve repair
|
527
|
6
|
1
|
0
|
528
|
6
|
1.1
|
|
Repair
|
521
|
6
|
1
|
0
|
522
|
6
|
1.1
|
|
Implantation
|
6
|
0
|
0
|
0
|
6
|
0
|
0.0
|
|
Aortic + mitral valve implantation
|
38
|
3
|
1
|
0
|
39
|
3
|
7.7
|
|
Aortic valve implantation[a] + CABG
|
24
|
1
|
13
|
2
|
37
|
3
|
8.1
|
|
Mitral valve implantation[b] + CABG
|
4
|
1
|
2
|
0
|
6
|
1
|
16.7
|
|
Aortic + mitral valve + CABG
|
0
|
0
|
0
|
0
|
0
|
0
|
–
|
|
Total
|
19,077
|
350
|
208
|
37
|
19,285
|
387
|
2.0
|
Notes: Pulmonary valve implantation for CHD excluded; 5% 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.
Concerning the transmitted 36,122 CABG procedures, 77.4% were performed as isolated
operations (n = 27,947), 11.8% (n = 4,267) combined with surgical aortic valve replacement (sAVR) and 5.2% (n = 1,896) with simultaneous mitral valve operations ([Table C1]). These numbers depict a minimal decline compared to the previous year. [Table C2] provides an overview of the isolated CABG operations focused on the number of bypass
grafts and indicates the corresponding unadjusted mortality rates for on/off pump
surgery. While the total number of isolated CABG procedures showed a small decrease,
the subgroup of isolated CABG without ECC increased to 6,667 (2020: 6,440). In addition,
the unadjusted mortality rate of this subgroup decreased to 1.6% (2020: 2.0%), independent
of the number of bypasses. In this context it has to be taken into account that conversions
from off- to on-pump CABG are not captured. [Tables Con1] and [2] show data concerning congenital heart surgery procedures. In this subcategory the
total number (n = 5,589) shows a small decline, meanwhile the unadjusted overall mortality rate changed
to 2.1% ([Table Con1]) compared to 2020 (n = 5,637; 2.6%;) and 2019 (n = 5,834; 2.7%), respectively. [Tables Mis 1]
[2]
[3]
[4]
[5] demonstrate further compiled registry data under different aspects and for various
categories like the Ross procedure, heart and lung transplantations, aortic surgery
and heart rhythm procedures. With a total of 18,576 specified pacemaker and ICD procedures,
the number declined by almost 3.2% (2020: 19,187) ([Fig. 11]), while the unadjusted mortality rate increased for pacemaker procedures to 0.9%
(2020: 0.7%) and for ICD procedures to 1.2% (2020: 0.9%) ([Table Mis4]). As expected, the highest mortality rates for both CIED procedures were detected
in the revision categories.
Table C1
Isolated CABG and combined procedures with/without ECC
|
n
|
†
|
%
|
|
Isolated CABG
|
27,947
|
751
|
2.7
|
|
+ Aortic valve replacement
|
4,267
|
215
|
5.0
|
|
+ Other
|
1,468
|
69
|
4.7
|
|
+ Mitral valve repair
|
1,094
|
46
|
4.2
|
|
+ Mitral valve replacement
|
802
|
130
|
16.2
|
|
+ Aortic valve replacement + mitral valve repair
|
177
|
19
|
10.7
|
|
+ Aortic + mitral valve replacement
|
245
|
53
|
21.6
|
|
+ Aneurysmal resection
|
79
|
7
|
8.9
|
|
+ Transcatheter aortic valve implantation
|
37
|
3
|
8.1
|
|
+ Transcatheter mitral valve procedure
|
6
|
1
|
16.7
|
|
Total
|
36,122
|
1,294
|
3.6
|
Table C2
Isolated CABG on-/off-pump surgery
|
Grafts
|
On-Pump
|
Off-Pump
|
Total
|
|
n
|
†
|
%
|
n
|
†
|
%
|
n
|
†
|
%
|
|
Single
|
527
|
29
|
5.5
|
1,205
|
15
|
1.2
|
1,732
|
44
|
2.5
|
|
Double
|
4,194
|
145
|
3.5
|
1,783
|
35
|
2.0
|
5,977
|
180
|
3.0
|
|
Triple
|
9,456
|
267
|
2.8
|
2,515
|
38
|
1.5
|
11,971
|
305
|
2.5
|
|
Quadruple
|
5,374
|
140
|
2.6
|
912
|
17
|
1.9
|
6,286
|
157
|
2.5
|
|
Quintuple + more
|
1,729
|
60
|
3.5
|
252
|
5
|
2.0
|
1,981
|
65
|
3.3
|
|
Total
|
21,280
|
641
|
3.0
|
6,667
|
110
|
1.6
|
27,947
|
751
|
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
|
2,030
|
676
|
65
|
16
|
3.2
|
2.4
|
|
1–17
|
1,747
|
196
|
20
|
0
|
1.1
|
0.0
|
|
≥ 18
|
922
|
18
|
19
|
0
|
2.1
|
0.0
|
|
Total
|
4,699
|
890
|
104
|
16
|
2.2
|
1.8
|
Table Con2
Procedures for congenital heart disease with and without ECC
|
Lesion/Procedure
|
Age < 1 y
|
Age 1 to 17 y
|
Age ≥18 y
|
|
n
|
†
|
%
|
n
|
†
|
%
|
n
|
†
|
%
|
|
ASD
|
37
|
0
|
0.0
|
238
|
0
|
0.0
|
204
|
1
|
0.5
|
|
Complete AV-canal
|
173
|
0
|
0.0
|
103
|
1
|
1.0
|
5
|
0
|
0.0
|
|
VSD
|
288
|
2
|
0.7
|
104
|
1
|
1.0
|
12
|
0
|
0.0
|
|
Fallot's tetralogy
|
193
|
0
|
0.0
|
24
|
0
|
0.0
|
2
|
0
|
0.0
|
|
DORV
|
53
|
0
|
0.0
|
11
|
1
|
9.1
|
1
|
0
|
0.0
|
|
TGA
|
147
|
1
|
0.7
|
2
|
0
|
0.0
|
0
|
–
|
–
|
|
TGA + VSD
|
70
|
2
|
2.9
|
3
|
0
|
0.0
|
0
|
–
|
–
|
|
Truncus arteriosus
|
33
|
0
|
0.0
|
10
|
0
|
0.0
|
0
|
–
|
–
|
|
Fontan circulation
|
2
|
0
|
0.0
|
292
|
5
|
1.7
|
3
|
0
|
0.0
|
|
Norwood
|
133
|
22
|
16.5
|
1
|
0
|
0.0
|
0
|
–
|
–
|
|
Pulmonary valve
|
63
|
2
|
3.2
|
180
|
1
|
0.6
|
76
|
3
|
3.9
|
|
Transcatheter pulmonary valve implantation
|
0
|
−
|
−
|
7
|
0
|
0.0
|
4
|
0
|
0.0
|
|
Aortic valve
|
53
|
1
|
1.9
|
176
|
0
|
0.0
|
338
|
2
|
0.6
|
|
Ross procedure
|
5
|
0
|
0.0
|
20
|
1
|
5.0
|
31
|
0
|
0.0
|
|
Mitral valve
|
27
|
0
|
0.0
|
117
|
3
|
2.6
|
93
|
8
|
8.6
|
|
Tricuspid valve
|
103
|
2
|
1.9
|
87
|
0
|
0.0
|
44
|
3
|
6.8
|
|
PDA
|
153
|
8
|
5.2
|
18
|
0
|
0.0
|
2
|
0
|
0.0
|
|
Coarctation
|
238
|
3
|
1.3
|
26
|
0
|
0.0
|
3
|
0
|
0.0
|
|
Others
|
929
|
38
|
4.1
|
479
|
7
|
1.5
|
122
|
2
|
1.6
|
|
HTx
|
6
|
0
|
0.0
|
39
|
0
|
0.0
|
0
|
–
|
–
|
|
HLTx
|
0
|
–
|
–
|
0
|
–
|
–
|
0
|
–
|
–
|
|
LTx
|
0
|
–
|
–
|
6
|
0
|
0.0
|
0
|
–
|
–
|
|
Total
|
2,706
|
81
|
3.0
|
1,943
|
20
|
1.0
|
940
|
19
|
2.0
|
Table Mis1
Ross procedures (autologous AV and PVR)
|
Age (years)
|
2012
|
2013
|
2014
|
2015
|
2016
|
2017
|
2018
|
2019
|
2020
|
2021
|
|
<18
|
36
|
33
|
37
|
28
|
38
|
38
|
29
|
32
|
35
|
25
|
|
≥18
|
117
|
107
|
90
|
64
|
72
|
52
|
61
|
104
|
70
|
124
|
|
Total
|
153
|
140
|
127
|
92
|
110
|
90
|
90
|
136
|
105
|
149
|
Table Mis2
Heart and lung transplantation
|
Transplant
|
With ECC
|
Without ECC
|
|
n
|
†
|
%
|
n
|
†
|
%
|
|
HTx
|
329
|
26
|
7.9
|
|
|
|
|
HLTx
|
1
|
0
|
0.0
|
|
|
|
|
LTx
|
93
|
8
|
8.6
|
161
|
9
|
5.6
|
Notes: All pediatric transplantations (demonstrated in [Table Con2]) are included in this table.
Note: Eurotransplant (ET) report 2021: 324 HTx, 2 HTx + kidneyTx, 1 HTx + liverTx,
2 HLTx, 264 DLTx, 16 SLTx, 0 LTx + kidneyTx and 1 LTx + liverTx.
Table Mis3
Aortic surgery
|
Replacement[a]
|
With ECC
|
Without ECC
|
|
N
|
†
|
%
|
n
|
†
|
%
|
|
Supracoronary replacement of ascending aorta
|
1,173
|
85
|
7.2
|
|
|
|
|
Supracoronary ascending + aortic valve replacement
|
1,133
|
45
|
4.0
|
|
|
|
|
Infracoronary replacement of ascending aorta
|
|
|
|
|
|
|
|
Mechanical aortic valve conduits
|
309
|
16
|
5.2
|
|
|
|
|
Biological aortic conduits
|
1,023
|
102
|
10.0
|
|
|
|
|
David procedure
|
502
|
7
|
1.4
|
|
|
|
|
Yacoub procedure
|
108
|
5
|
4.6
|
|
|
|
|
Other
|
292
|
21
|
7.2
|
|
|
|
|
Aortic arch replacement[b]
|
2,815
|
400
|
14.2
|
|
|
|
|
Replacement of descending aorta
|
65
|
3
|
4.6
|
6
|
1
|
16.7
|
|
Thoraco-abdominal aortic replacement
|
75
|
12
|
16.0
|
20
|
1
|
5.0
|
|
Endostent descending aorta
|
4
|
3
|
75.0
|
678
|
21
|
3.1
|
|
Total
|
7,499
|
699
|
9.3
|
704
|
23
|
3.3
|
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: 442 abdominal procedures and 34
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
|
12,443
|
118
|
0.9
|
8
|
1
|
12,435
|
117
|
|
Implantation
|
8,478
|
75
|
0.9
|
4
|
0
|
8,474
|
75
|
|
Battery exchange
|
1,706
|
3
|
0.2
|
0
|
0
|
1,706
|
3
|
|
Revision procedures
|
2,259
|
40
|
1.8
|
4
|
1
|
2,255
|
39
|
|
ICD
|
6,133
|
72
|
1.2
|
18
|
5
|
6,115
|
67
|
|
Implantation
|
2,445
|
11
|
0.4
|
1
|
0
|
2,444
|
11
|
|
Battery exchange
|
1,499
|
2
|
0.1
|
1
|
0
|
1,498
|
2
|
|
Revision procedures
|
2,189
|
59
|
2.7
|
16
|
5
|
2,173
|
54
|
|
Miscellaneous
|
914
|
10
|
1.1
|
9
|
0
|
905
|
10
|
|
Total
|
19,490
|
200
|
1.0
|
35
|
6
|
19,455
|
194
|
Table Mis5
Surgical procedures for tachyarrhythmia
|
Energy source
|
Endocardiac
|
Epicardiac
|
Total
|
|
n
|
n
|
|
Unipolar radio frequency
|
55
|
244
|
299
|
|
Unipolar cooled radio frequency
|
57
|
102
|
159
|
|
Bipolar radiofrequency
|
234
|
1,598
|
1,832
|
|
Cryothermy
|
1,331
|
324
|
1,655
|
|
Microwave
|
0
|
0
|
0
|
|
Focused ultrasound
|
2
|
98
|
100
|
|
Laser
|
0
|
0
|
0
|
|
Other
|
6
|
3
|
9
|
|
Total
|
1,685
|
2,369
|
4,054
|
Note: 223 procedures are unspecified with regard to endo-/epicardiac ablation.
Compared to the data of previous years, some significant changes can be seen on one
hand, while several developments remained almost unchanged in 2021 on the other hand.
The number of CABG procedures, isolated or combined, shows a further decrease of 4.9%
in 2021, considerably less than the decline of the previous year (13.9%). The number
of isolated heart valve procedures rose to the level of 2019 (increase of 3.5%) ([Fig. 1]). However, unadjusted mortality rates for CABG, AVR vary just slightly over the
last decade ([Fig. 2]). The age distribution of patients continues to evolve toward a higher percentage
of elderly patients (≥80 years) as well as a continuous increase of adults ≤69 years
(49.5%) ([Fig. 3]). Presently, 29.8% of the cardiac procedures are performed in patients from 70 to
79 years of age, and 20.7% in octo-/nonagenarians. The relative amount of isolated
off-pump CABG increases steadily, reaching 23.9% in 2021 (2020: 21.9%) ([Fig. 4]).
Fig. 1 Selected heart surgical categories (2012–2021). Notes: Congenital heart surgery:
atrial septal defect repairs in adults or in combination with coronary artery bypass
grafting (CABG) or heart valve procedures are summarized in the CABG or heart valve
procedure groups; miscellaneous procedures: all other types of procedures with extracorporeal
circulation.
Fig. 2 Unadjusted mortality for selected procedures (2012–2021).
Fig. 3 Age distribution of cardiac procedures (2012–2021). Notes: Patients <20 years and
CIED procedures were excluded.
Fig. 4 Isolated coronary artery bypass grafting (CABG) (2012–2021)
With regard to heart valve prostheses distribution, in 90.0% (n = 6,754) sAVR was performed using a xenograft ([Fig. 5]), whereas in 10.0% (n = 748) a mechanical prosthesis was implanted: a consistent proportion over the past
5 years. The unchanged development of transcatheter heart valve procedures in Germany
led to a total of 19,285 transferred procedures in 2021 ([Table V6]). Focused on the distribution of aortic valve procedures for 2021, 16,903 (69.2%)
TAVI and 7,523 (30.8%) sAVR were reported to the registry ([Fig. 6]). It must be emphasized that exclusively the German departments for cardiac surgery
contribute to these data. Therefore, the registry cannot reach completeness of TAVI
data due to the fact that procedures documented by cardiology departments are incompletely
included. On the basis of and in addition to the recommendations of international
scientific guidelines and expert consensus on the management of valvular heart disease,
respectively,[8]
[9]
[10] the German Federal Joint Committee (G-BA) implemented a quality assurance directive[11] for “minimally invasive heart valve interventions (TAVI, transcatheter mitral clip
reconstruction)” in 2015, which is still under evaluation. Further surveys for selected
procedures, such as the legally compulsory quality assurance (§135a SGB V) or the
voluntary nationwide German Aortic Valve Registry (GARY),[12]
[13]
[14]
[15]
[16]
[17]
[18]
[19]
[20]
[21]
[22]
[23]
[24]
[25] provide various important findings and thus also contribute to an exceptional patient
benefit.
Fig. 5 Isolated aortic valve (AV) replacement (2012–2021). Notes: Ross procedures, homograft
implantations, and transcatheter heart valve interventions excluded.
Fig. 6 Isolated aortic valve replacement and transcatheter aortic valve implantation (TAVI)
(2012–2021) + additional TAVI procedures calculated from the German legal quality
assurance program, §§ 135a/ 136/ 137 SGB V. TAVI, transcatheter heart valve intervention.
In 2021, the rate of isolated mitral valve reconstructions remains almost unchanged
on a remarkable level of 63.3% (2020: 64.1%) ([Fig. 7]). Based on the fact that all isolated mitral valve procedure are 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)
like in other publications, e.g., Gammie et al.[26] Therefore, other published rates of mitral valve repair have to be interpreted with
caution if compared to this registry.
Fig. 7 Isolated mitral valve surgery (2012–2021).
In 2021 almost half (48.5%; n = 2,685) of cardiac operations for CHD were performed in neonates/infants <1 year,
34.6% in children between 1 and 17 years and 16.9% in patients at least 18 years of
age ([Fig. 8]). These numbers show a quite steady level over the past decade.
Fig. 8 Age distribution for congenital heart disease (CHD) (2012–2021). 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).
Concerning ventricular assist device (L-/ R-/ BVAD, TAH) implantations (n = 750) a further significant decrease of 11.0% compared to 2020 (n = 843) ([Fig. 9]) could be observed, while the total number of heart transplantations decreased to
329, a decline of 3.2% compared to the previous year ([Fig. 10]). Nevertheless, the mechanical circulatory support therapy, in particular LVAD,
is still of outstanding importance for patients with end-stage heart failure.
Fig. 9 Mechanical circulatory support devices (2012–2021).
Fig. 10 Heart transplantation (2012–2021).
Fig. 11 Pacemaker and ICD procedures (2012–2021).
Discussion
Even under the exceptional conditions of the further ongoing COVID-19 pandemic, the
registry of the GSTCVS enables a comprehensive overview of all heart surgical procedures
performed in German cardiac surgery departments in 2021. The accuracy of this registry
remains 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.[27] As observed in recent years, heart surgery in Germany is 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 could be
always enabled (24/7/365) nationwide, even under COVID-19 conditions. These aspects
are especially important in the context of various developments in the German health
care policy and considering the background of demographic trends of the German population,
leading to more patients at increased age combined with a higher proportion of related
comorbidities and an accordingly complex perioperative risk profile.
Compared to 2020, the number of cardiac surgery procedures showed a smaller decrease
for isolated/combined CABG and sAVR than in 2019 to 2020, an ongoing trend in the
view of the German population characteristics and in the context of application of
scientific guidelines.[10]
[28]
[29] Despite this, for the years 2020 und 2021 it must be taken into account that the
care of patients with heart disease was affected by the consequences of SARS-CoV-2
pandemic with shutdowns and restrictions, respectively. Due to limited intensive care
resources in all German cardiac centers, provision of elective/urgent heart surgical
procedures was affected substantially. Otherwise, the low level in heart transplantations
needs more efforts for a positive development in the future, even when the COVID pandemic
will have been overcome.
Further improvements of 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 German Society for Thoracic and Cardiovascular Surgery and all
German cardiac surgical departments. 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.
