Keywords
heart surgery - outcome - registry - quality assurance - congenital heart disease
- aortic surgery - transplantation
Introduction
Legitimate demands for a sophisticated quality management in medicine—by authorities,
scientific organizations, health insurance companies, and patients all over the world—have
stimulated quality awareness, resulting in the development of versatile quality assurance
activities such as benchmark projects, registries, and others to answer those needs.
As early as 1978, the board of directors of the German Society for Thoracic and Cardiovascular
Surgery (GSTCVS; www.dgthg.de) decided to set up an annual database of all cardiac surgical procedures in terms
of a voluntary registry. Since 1989, the data are annually updated, summarized in
a registry format, and published in the scientific journal of the GSTCVS.[1]
[2]
[3]
[4]
[5]
[6]
[7]
[8]
[9]
[10]
[11]
[12]
[13]
[14]
[15]
[16]
[17]
[18]
[19]
[20]
[21]
[22]
[23]
[24]
[25]
[26] The aims of this registry are to gather developments and current trends in cardiac
surgery in Germany, to compile various results for nearly all cardiac surgical procedures,
to enable each participating department for cardiac surgery comparing its own results
to the nationwide achievements, and to facilitate an evaluation on an international
level for the society.
In order to monitor actual conditions as well as developments in cardiac medicine,
the registry covers all relevant techniques as well as innovative technologies including
minimally invasive cardiac surgery and all kinds of heart valve operations including
transcatheter heart valve interventions (e.g., transcatheter aortic valve implantation,
TAVI). Thereby, important findings for current patient safety and the future of patient
care are collected and may be evaluated under different aspects.
Data and results presented in this report comprehend assorted data of 2015.
Material and Methods
Since 2004, a standardized questionnaire gathers well-defined information for all
individual procedures exactly described by an annually updated German adaption of
the International Classification of Procedures in Medicine (ICPM) called operation
code (Operationen- und Prozedurenschlüssel).
All participating institutions were requested to complete the structured questionnaire,
asking for all performed procedures and associated inhospital mortality, by January
24, 2016. The recommended path for data export is electronic transmission of an encrypted
file to the office of the GSTCVS in Berlin. After transaction, the data are decrypted,
evaluated for completeness, and compiled for further analysis, thus ensuring anonymity
for each participating institution. This compilation algorithm guarantees a high compliance
for submission of complete datasets.
Inclusion criteria for the 2015 registry were all cardiac surgical procedures performed
on patients between January 1, 2015, and December 31, 2015, unrelated to the date
of admission or discharge as compared with other registries. Like in all previous
years, the number of procedures was counted rather than individual patients. For example,
if during one admission a patient required coronary bypass grafting due to a complication
following initial mitral valve reconstruction, one count in the “mitral valve reconstruction”
category and another in the “coronary surgery” category are enumerated. Thus, the
registry contains a higher number of procedures than the real number of patients operated
on.
Death of patients was defined as inhospital 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
of coronary artery bypass grafting (CABG) would only be attributed to the coronary
procedure. The denominator in the calculation of mortality rates is getting falsly
higher with the assignment of complication procedures resulting in a marginal underestimation
of mortality rates (calculus estimate: <0.1%).
The main reason for this structural setup of the registry established over several
decades is to keep in accordance with the German data privacy act with its specific
regulations for patients. Furthermore, it seemed to be relevant getting not only the
count of treated patients but also detailed information about all performed procedures.
Last but not least, the process of data acquisition had to be standardized and feasible
for all participating cardiac surgery departments in Germany, thus enabling the submission
of a complete dataset, regardless of the locally existing hard- and software used
for data management.
In 2015, a total of 78 institutions performed heart surgery in Germany. Fortunately,
all units answered the questionnaire and delivered a complete dataset for 2015 including
hospital mortality rates.
Registry Data 2015
[Table 1] gives an overview of heart surgical procedures by distribution between the 16 German
states. In the table, the range of heart operations per 100,000 inhabitants shows
a minimum of 101.8 (Baden-Württemberg) and a maximum of 168.9 (Sachsen-Anhalt), resulting
in a nationwide mean value of 126.6. Analyzing the heart operations for department
dimension, 59% performed from 590 to 1,460 procedures ([Table 2]). Summarizing the departments by various heart surgical procedures, it can be ascertained
that heart operations in patients for congenital heart disease (<1 year, with extracorporeal
circulation [ECC]) are conducted in 23 and heart transplantations in 22 institutions
([Table 3]). [Table 4] illustrates the number of procedures using ECC from 2006 to 2015 in Germany. Over
the past decade, the number of heart operations using ECC shows a diminution by 9,530
procedures, certainly an achievement of establishing innovations and minimally invasive
therapies in heart surgery.
Table 1
Heart operations in German states
|
German states
|
Quantity[a]
|
Population[b]
|
Heart procedures/100,000 inhabitants
|
|
Baden-Württemberg
|
10,907
|
10,716,644
|
101.8
|
|
Bayern
|
14,542
|
12,691,568
|
114.6
|
|
Berlin
|
3,800
|
3,469,849
|
109.5
|
|
Brandenburg
|
3,194
|
2,457,872
|
129.9
|
|
Bremen
|
812
|
661,888
|
122.7
|
|
Hamburg
|
2,168
|
1,762,791
|
123.0
|
|
Hessen
|
7,875
|
6,093,888
|
129.2
|
|
Mecklenburg-Vorpommern
|
2,134
|
1,599,138
|
133.4
|
|
Niedersachsen
|
10,848
|
7,826,739
|
138.6
|
|
Nordrhein-Westfalen
|
23,164
|
17,638,098
|
131.3
|
|
Rheinland-Pfalz
|
5,637
|
4,011,582
|
140.5
|
|
Saarland
|
1,644
|
989,035
|
166.2
|
|
Sachsen
|
5,271
|
4,055,274
|
130.0
|
|
Sachsen-Anhalt
|
3,776
|
2,235,548
|
168.9
|
|
Schleswig-Holstein
|
4,180
|
2,830,864
|
147.7
|
|
Thüringen
|
2,843
|
2,156,759
|
131.8
|
|
Total
|
102,795
|
81,197,537
|
126.6
|
a 1,172 foreign residents excluded.
b Federal Offices for Statistics of German Population; due date December 31, 2014.
Table 2
Departments sorted by quantity (n = 103.967)
|
Procedures (quantity)
|
<500
|
500–999
|
1,000–1,499
|
1,500–1,999
|
2,000–5,000
|
|
Departments (no.)
|
7
|
21
|
25
|
12
|
13
|
|
Average
|
346
|
814
|
1,198
|
1,663
|
2,658
|
|
Range
|
233–445
|
590–992
|
1,032–1,460
|
1,508–1,966
|
2,021–4,102
|
Note: Pacemaker/ implantable cardioverter defibrillator and extracardiac surgery without
extracorporeal circulation excluded.
Table 3
Departments summarized by heart surgery procedures in 2015
|
Procedures
|
N
|
|
Coronary artery bypass grafting
|
77
|
|
Heart valve surgery
|
77
|
|
Surgery for CHD patients < 1 yr with ECC
|
23[a]
|
|
HTx
|
22[b]
|
|
HLTx
|
2
|
a
N = 2,041: 3–17 procedures in 4 units, 22–46 procedures in 5 units, 65–89 procedures
in 5 units, and 110–265 procedures in 9 units.
b
N = 283: 23–75 Tx in 4 units, 11–17 Tx in 5 units, 5–8 Tx in 8 units, and 2–4 Tx in
5 units.
Table 4
Open heart procedures using extracorporeal circulation (2006–2015)
|
2006
|
2007
|
2008
|
2009
|
2010
|
2011
|
2012
|
2013
|
2014
|
2015
|
|
Departments
|
80
|
80
|
79
|
80
|
79
|
78
|
79
|
79
|
78
|
78
|
|
Procedures
|
91,057
|
91,618
|
89,773
|
86,916
|
84,686
|
84,402
|
84,388
|
84,040
|
83,787
|
81,527
|
|
Average
|
1,138
|
1,145
|
1,136
|
1,086
|
1,072
|
1,082
|
1,068
|
1,064
|
1,074
|
1,045
|
Overall, 185,270 procedures were reported to the registry in 2015, a decrease of 1.1%
compared to 2014 (187,392 procedures). A total of 103,967 heart surgical procedures
(excluding implantable cardioverter defibrillator, pacemakers, and miscellaneous procedures
without ECC) in 2015 displays nearly the same quantity with a difference of just 0.5%
(n = 517) compared to 2014 (104,484 procedures; [Table 5]). [Tables 6] and [7], [V1]
[V2]
[V3]
[V4]
[V5]
[V6] to [V7], [C1] and [C2], [Con1] and [Con2], and [Mis1]
[Mis2]
[Mis3]
[Mis4] to [Mis5] and [Figs. 1]
[2]
[3]
[4]
[5]
[6]
[7]
[8]
[9] demonstrate some compiled registry data of 2015 under different aspects and for
various categories.
Table 5
Heart surgery categories 2015
|
Category
|
with ECC
|
without ECC
|
Total
|
Diff. 2014 (%)
|
|
Coronary artery bypass grafting
|
45,107
|
6,834
|
51,941
|
–3.5
|
|
Heart valve procedures
|
21,892
|
10,454
|
32,346
|
+3.1
|
|
Surgery of thoracic aorta
|
7,265
|
657
|
7,922
|
+2.2
|
|
Surgery for CHD
|
4,913
|
979
|
5,892
|
+2.0
|
|
Cardiac surgery and others
|
1,173
|
1,206
|
2,379
|
–3.8
|
|
Assist device procedures
|
765
|
2,310
|
3,075
|
+5.7
|
|
Extracardiac surgery
|
358
|
54,785
|
55,143
|
–3.4
|
|
Pacemaker and ICD procedures
|
54
|
26,518
|
26,572
|
+1.2
|
|
Total
|
81,527
|
103,743
|
185,270
|
–1.1
|
Table 6
Additional data for heart surgery procedures with ECC in 2015 versus 2014
|
Procedures
|
2015
|
2014
|
|
N
|
%
|
N
|
%
|
|
Emergency
|
12,843
|
12.4%
|
12,583
|
12.0%
|
|
Redo
|
8,994
|
8.7%
|
8,809
|
8.4%
|
Table 7
Gender distribution
|
Female (%)
|
Male (%)
|
|
Heart valve procedures
|
44
|
56
|
|
Coronary procedures
|
22
|
78
|
|
Surgery for CHD
|
44
|
56
|
|
Surgery of thoracic aorta
|
33
|
67
|
|
Cardiac surgery, other
|
52
|
48
|
|
Assist Devices
|
29
|
71
|
|
Pacemaker and ICD
|
35
|
65
|
|
Extracardiac surgery
|
34
|
66
|
|
Total
|
33
|
67
|
Table V1
Isolated heart valve procedures
|
Procedures
|
N
|
†
|
%
|
|
Single
|
17,986
|
649
|
3.6
|
|
Double
|
3,280
|
305
|
9.3
|
|
Triple
|
358
|
47
|
13.1
|
|
Transcatheter access(single valve)
|
10,581
|
405
|
3.8
|
|
Transcatheter access(double valve)
|
25
|
2
|
8.0
|
|
Not specified
|
116
|
6
|
5.2
|
|
Total
|
32,346
|
1,414
|
4.4
|
Transcatheter heart valve procedures: 9,813 aortic valve implantations; 111 mitral
valve implantations; 632 mitral valve repairs; 1 tricuspid valve implantation; 24
tricuspidal valve repairs; 25 combined aortic and mitral valve procedures; no pulmonary
valve implantation.
Table V2
Single heart valve procedures: access type
|
Heart valve/access
|
N
|
†
|
%
|
|
Aortic valve
|
21,120
|
715
|
3.4
|
|
Sternotomy
|
8,291
|
292
|
3.5
|
|
Part. sternotomy
|
3,016
|
49
|
1.6
|
|
Transvascular
|
7,311
|
218
|
3.0
|
|
Transapical
|
2,502
|
156
|
6.2
|
|
Mitral valve
|
6,770
|
283
|
4.2
|
|
Sternotomy
|
3,099
|
205
|
6.6
|
|
Minimally invasive
|
2,928
|
49
|
1.7
|
|
Transcatheter
|
743
|
29
|
3.9
|
|
Tricuspidal valve
|
617
|
53
|
8.6
|
|
Sternotomy
|
444
|
45
|
10.1
|
|
Minimally invasive
|
148
|
6
|
4.1
|
|
Transcatheter
|
25
|
2
|
8.0
|
|
Pulmonary valve
|
56
|
3
|
5.4
|
|
Sternotomy
|
56
|
3
|
5.4
|
|
Minimally invasive
|
0
|
0
|
–
|
|
Transcatheter
|
0
|
0
|
–
|
|
Total
|
28,563
|
1,054
|
3.7
|
Note: Apical aortic conduits procedures (n = 4) excluded.
Table V3
Isolated aortic valve procedures
|
Prosthesis/repair
|
N
|
†
|
%
|
|
Xenograft
|
9,839
|
311
|
3.2
|
|
Mechanical prosthesis
|
1,311
|
23
|
1.8
|
|
Repair
|
124
|
5
|
4.0
|
|
Homograft
|
33
|
2
|
6.1
|
|
Total
|
11,307
|
341
|
3.0
|
Table V4
Isolated mitral valve procedures
|
Prosthesis/repair
|
N
|
†
|
%
|
|
Repair
|
3,833
|
52
|
1.4
|
|
Xenograft
|
1,680
|
165
|
9.8
|
|
Mechanical prosthesis
|
505
|
35
|
6.9
|
|
Homograft
|
9
|
2
|
22.2
|
|
Total
|
6,027
|
254
|
4.2
|
Table V5
Multiple heart valve procedures
|
N
|
†
|
%
|
|
Mitral + tricuspid
|
1,685
|
118
|
7.0
|
|
Aortic + mitral
|
1,372
|
170
|
12.4
|
|
Aortic + mitral + tricuspid
|
357
|
47
|
13.2
|
|
Aortic + tricuspid
|
174
|
15
|
8.6
|
|
Aortic + pulmonary[a]
|
39
|
1
|
2.6
|
|
Tricuspid + pulmonary
|
10
|
1
|
10.0
|
|
Aortic + mitral + pulmonary
|
1
|
0
|
0.0
|
|
Total
|
3,638
|
352
|
9.7
|
Note: Transcatheter procedures excluded.
a Ross procedures included.
Table V6
Isolated/combined mitral valve procedures: implantation/replacement vs. repair
|
Mitral valve surgery
|
Repair
|
Implantation/replacement
|
All procedures
|
|
N
|
†
|
%
|
N
|
†
|
%
|
N
|
% repair
|
†
|
%
|
|
Isolated
|
3,833
|
52
|
1.4
|
2,194
|
202
|
9.2
|
6,027
|
63.6
|
254
|
4.2
|
|
+ Aortic valve
|
603
|
38
|
6.3
|
769
|
132
|
17.2
|
1,372
|
44.0
|
170
|
12.4
|
|
+ Tricuspid valve repair[a]
|
1,025
|
44
|
4.3
|
611
|
66
|
10.8
|
1,636
|
62.7
|
110
|
6.7
|
|
+ CABG
|
1,711
|
132
|
7.7
|
918
|
134
|
14.6
|
2,629
|
65.1
|
266
|
10.1
|
|
+ CABG + aortic valve replacement
|
318
|
40
|
12.6
|
286
|
59
|
20.6
|
604
|
52.6
|
99
|
16.4
|
|
Total
|
7,490
|
306
|
4.1
|
4,778
|
593
|
12.4
|
12.268
|
61.1
|
899
|
7.3
|
a A total of 49 procedures (not specified mitral valve + tricuspid valve surgery) excluded;
†: (8/49) 16%.
Table V7
Transcatheter heart valve procedures
|
without ECC
|
with ECC
|
All procedures
|
|
N
|
†
|
N
|
†
|
N
|
†
|
%
|
|
Aortic valve implantation
|
9,675
|
330
|
138
|
44
|
9,813
|
374
|
4
|
|
Transvascular
|
7,236
|
192
|
75
|
26
|
7,311
|
218
|
3
|
|
Transapical
|
2,439
|
138
|
63
|
18
|
2,502
|
156
|
6
|
|
Mitral valve procedure
|
731
|
26
|
12
|
3
|
743
|
29
|
4
|
|
Repair
|
625
|
20
|
7
|
1
|
632
|
21
|
3
|
|
Implantation
|
106
|
6
|
5
|
2
|
111
|
8
|
7
|
|
Tricuspidal valve procedure
|
23
|
1
|
2
|
1
|
25
|
2
|
8
|
|
Repair
|
22
|
1
|
2
|
1
|
24
|
2
|
8
|
|
Implantation
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Aortic + mitral valve implantation
|
25
|
2
|
0
|
0
|
25
|
2
|
8
|
|
Aortic valve implantation[a] + CABG
|
37
|
2
|
13
|
8
|
50
|
10
|
20
|
|
Mitral valve implantation[b] + CABG
|
1
|
0
|
1
|
1
|
2
|
1
|
50
|
|
Aortic + mitral valve + CABG
|
2
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Total
|
10,494
|
361
|
166
|
57
|
10,660
|
418
|
4
|
Note: Pulmonary valve implantations for the correction of congenital lesions are not
included; No procedure was reported for adults without congenital lesion. 25% of TAVI
by transapical access; 1.5% of TAVI under use of ECC.
a Femoral, subclavian, or transaortic access.
b Transvascular and transapical access.
Table C1
Isolated/combined CABG with ECC
|
N
|
†
|
%
|
|
Isolated CABG
|
38,601
|
1,057
|
2.7
|
|
+ Aortic valve replacement
|
7,214
|
396
|
5.5
|
|
+ Other
|
2,705
|
156
|
5.8
|
|
+ Mitral valve repair
|
1,711
|
132
|
7.7
|
|
+ Mitral valve replacement
|
918
|
134
|
14.6
|
|
+ Aortic valve replacement + mitral valve repair
|
318
|
40
|
12.6
|
|
+ Aortic + mitral valve replacement
|
286
|
59
|
20.6
|
|
+ Aneurysm resection
|
133
|
7
|
5.3
|
|
+ Transcatheter aortic valve implantation
|
50
|
10
|
20.0
|
|
+ TMLR
|
1
|
0
|
0.0
|
|
Total
|
51,937
|
1,991
|
3.8
|
Table C2
Isolated CABG with/without ECC
|
Grafts (N)
|
with ECC
|
without ECC
|
All
|
|
N
|
†
|
%
|
N
|
†
|
%
|
N
|
†
|
%
|
|
Single
|
1,009
|
56
|
5.6
|
1,359
|
32
|
2.4
|
2,368
|
88
|
3.7
|
|
Double
|
6,840
|
236
|
3.5
|
1,755
|
33
|
1.9
|
8,595
|
269
|
3.1
|
|
Triple
|
14,353
|
388
|
2.7
|
2,185
|
38
|
1.7
|
16,538
|
426
|
2.6
|
|
Quadruple
|
7,776
|
206
|
2.6
|
847
|
7
|
0.8
|
8,623
|
213
|
2.5
|
|
Quintuple + more
|
2,273
|
60
|
2.6
|
204
|
1
|
0.5
|
2,477
|
61
|
2.5
|
|
Total
|
32,251
|
946
|
2.9
|
6,350
|
111
|
1.7
|
38,601
|
1,057
|
2.7
|
Table Con1
Congenital heart surgery with/without ECC
|
Age (yrs)
|
N
|
†
|
%
|
|
with ECC
|
without ECC
|
with ECC
|
without ECC
|
with ECC
|
without ECC
|
|
<1
|
2,041
|
736
|
63
|
13
|
3.1
|
1.8
|
|
1–17
|
1,796
|
206
|
9
|
1
|
0.5
|
0.5
|
|
≥18
|
1,076
|
37
|
24
|
1
|
2.2
|
2.7
|
|
Total
|
4,913
|
979
|
96
|
15
|
2.0
|
1.5
|
Table Con2
Lesions/procedures for CHD with and without ECC
|
Lesion/procedures
|
Age < 1 yr
|
Age 1–17 yrs
|
Age ≥ 18 yrs
|
|
N
|
†
|
%
|
N
|
†
|
%
|
N
|
†
|
%
|
|
ASD
|
33
|
0
|
0.0
|
254
|
1
|
0.4
|
246
|
4
|
1.6
|
|
Complete AV canal
|
183
|
2
|
1.1
|
88
|
1
|
1.1
|
10
|
1
|
10.0
|
|
VSD
|
305
|
0
|
0.0
|
86
|
0
|
0.0
|
25
|
2
|
8.0
|
|
Fallot's tetralogy
|
205
|
3
|
1.5
|
49
|
0
|
0.0
|
2
|
0
|
0.0
|
|
DORV
|
48
|
0
|
0.0
|
21
|
1
|
4.8
|
1
|
0
|
0.0
|
|
TGA
|
160
|
2
|
1.3
|
10
|
0
|
0.0
|
2
|
0
|
0.0
|
|
TGA + VSD
|
63
|
2
|
3.2
|
10
|
0
|
0.0
|
0
|
0
|
–
|
|
Truncus arteriosus
|
38
|
3
|
7.9
|
7
|
0
|
0.0
|
0
|
0
|
–
|
|
Fontan
|
1
|
0
|
0.0
|
253
|
3
|
1.2
|
6
|
1
|
16.7
|
|
Norwood
|
146
|
20
|
13.7
|
1
|
0
|
0.0
|
0
|
0
|
–
|
|
Pulmonary valve
|
73
|
2
|
2.7
|
240
|
1
|
0.4
|
75
|
0
|
0.0
|
|
Transcatheter pulmonary valve implantation
|
0
|
–
|
–
|
4
|
0
|
0.0
|
17
|
0
|
0.0
|
|
Aortic valve
|
61
|
2
|
3.3
|
246
|
0
|
0.0
|
394
|
5
|
1.3
|
|
Ross procedure
|
7
|
1
|
14.3
|
21
|
0
|
0.0
|
29
|
0
|
0.0
|
|
Mitral valve
|
46
|
4
|
8.7
|
88
|
0
|
0.0
|
108
|
8
|
7.4
|
|
Tricuspid valve
|
95
|
1
|
1.1
|
59
|
0
|
0.0
|
62
|
2
|
3.2
|
|
PDA
|
225
|
3
|
1.3
|
26
|
1
|
3.8
|
2
|
0
|
0.0
|
|
Coarctation
|
218
|
4
|
1.8
|
39
|
0
|
0.0
|
7
|
0
|
0.0
|
|
Others
|
890
|
28
|
3.1
|
479
|
3
|
0.6
|
119
|
2
|
1.7
|
|
HTx
|
7
|
0
|
0.0
|
42
|
0
|
0.0
|
0
|
0
|
–
|
|
HLTx
|
0
|
–
|
–
|
0
|
0
|
–
|
0
|
0
|
–
|
|
LTx
|
0
|
–
|
–
|
9
|
0
|
0.0
|
0
|
0
|
–
|
|
Total
|
2,804
|
77
|
2.7
|
2,032
|
11
|
0.5
|
1,105
|
25
|
2.3
|
Table Mis1
Ross procedures (autologous AV- and PVR)
|
Age (y)
|
2006
|
2007
|
2008
|
2009
|
2010
|
2011
|
2012
|
2013
|
2014
|
2015
|
|
<18
|
50
|
34
|
42
|
54
|
43
|
40
|
36
|
33
|
37
|
28
|
|
≥18
|
228
|
261
|
207
|
175
|
184
|
134
|
117
|
107
|
90
|
64
|
|
Total
|
278
|
295
|
249
|
229
|
227
|
174
|
153
|
140
|
127
|
92
|
Table Mis2
Heart and lung transplantation
|
with ECC
|
without ECC
|
|
N
|
†
|
%
|
N
|
†
|
%
|
|
HTx
|
283
|
38
|
13,4
|
|
|
|
|
HLTx
|
2
|
0
|
0,0
|
|
|
|
|
LTx
|
57
|
13
|
22,8
|
206
|
13
|
6,3
|
Eurotransplant (ET) report for 2015: 283 HTx, 1 HTx + kidneyTx, 0 HTx + liverTx, 2
HLTx, 262 DLTx, 27 SLTx, 0 LTx + kidneyTx and 4 LTx + liverTx.
Table Mis3
Aortic surgery
|
Replacement[a]
|
with ECC
|
without ECC
|
|
N
|
†
|
%
|
N
|
†
|
%
|
|
Supracoronary replacement of ascending aorta
|
1,433
|
127
|
8.9
|
|
|
|
|
Supracoronary ascending + aortic valve replacement
|
1,329
|
63
|
4.7
|
|
|
|
|
Infracoronary ascending
|
|
|
–
|
|
|
|
|
Mechanical valve conduits
|
508
|
36
|
7.1
|
|
|
|
|
Biological valve conduits
|
989
|
109
|
11.0
|
|
|
|
|
David procedure
|
514
|
8
|
1.6
|
|
|
|
|
Yacoub procedure
|
89
|
3
|
3.4
|
|
|
|
|
Other
|
279
|
23
|
8.2
|
|
|
|
|
Aortic arch replacement[b]
|
1,977
|
271
|
13.7
|
|
|
|
|
Replacement of descending aorta
|
56
|
4
|
7.1
|
8
|
0
|
0.0
|
|
Thoracoabdominal aortic replacement
|
86
|
10
|
11.6
|
24
|
4
|
16.7
|
|
Endostent descending aorta
|
5
|
0
|
0.0
|
625
|
53
|
8.5
|
|
Total
|
7,265
|
654
|
9.0
|
657
|
57
|
8.7
|
a Procedures for abdominal aortic diseases excluded: 549 abdominal procedures and 609
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
|
N
|
†
|
%
|
with ECC
|
without ECC
|
|
|
|
N
|
†
|
N
|
†
|
|
Pacemaker
|
14,295
|
98
|
0.7
|
27
|
1
|
14,268
|
97
|
|
Implantation
|
9,337
|
68
|
0.7
|
8
|
1
|
9,329
|
67
|
|
Battery exchange
|
1,935
|
0
|
0.0
|
0
|
0
|
1,935
|
0
|
|
Revision
|
3,023
|
30
|
1.0
|
19
|
0
|
3,004
|
30
|
|
ICD
|
10,104
|
83
|
0.8
|
26
|
5
|
10,078
|
78
|
|
Implantation
|
4,673
|
19
|
0.4
|
0
|
0
|
4,673
|
19
|
|
Battery exchange
|
2,048
|
3
|
0.1
|
0
|
0
|
2,048
|
3
|
|
Revision
|
3,383
|
61
|
1.8
|
26
|
5
|
3,357
|
56
|
|
Miscellaneous
|
2,173
|
13
|
0.6
|
1
|
0
|
2,172
|
13
|
|
Total
|
26,572
|
194
|
0.7
|
54
|
6
|
26,518
|
188
|
Table Mis5
Surgical ablation therapy
|
Energy source
|
Total
|
Endocardiac
|
Epicardiac
|
|
N
|
N
|
|
Unipolar radiofrequency
|
229
|
77
|
152
|
|
Unipolar cryoradiofrequency
|
254
|
122
|
132
|
|
Bipolar radiofrequency
|
2.306
|
309
|
1,997
|
|
Cryothermy
|
1.606
|
1,340
|
266
|
|
Microwave
|
13
|
3
|
10
|
|
Focused ultrasound
|
66
|
7
|
59
|
|
Laser
|
9
|
1
|
8
|
|
Other
|
23
|
4
|
19
|
|
Total
|
4,506
|
1,863
|
2,643
|
Note: 496 procedures unspecified with regard to endocardiac/epicardiac ablation.
Fig. 1 Cardiac surgery in Germany (2006–2015). (1) Coronary artery bypass grafting (CABG)
and combined procedures: all types of coronary surgery. (2) Heart valve procedures:
combination with aortic surgery summarized under miscellaneous procedures. (3) Congenital
heart surgery: atrial septal defect repair in adults or in combination with CABG or
heart valve procedures are summarized in the CABG or heart valve procedure groups.
(4) Miscellaneous procedures: all other types of procedures with extracorporeal circulation.
Fig. 2 Unadjusted mortality for selected procedures (2006–2015).
Fig. 3 Isolated coronary artery bypass grafting (2006–2015).
Fig. 4 Isolated aortic valve replacement (2006–2015). Ross procedures, homograft implantations,
and transcatheter aortic valve implantation excluded.
Fig. 5 Isolated aortic valve replacement and transcatheter aortic valve implantation (TAVI).
+ Additional TAVI procedures calculated from the German legal quality assurance program
(§137 SGB V).
Fig. 6 Age distribution of cardiac procedures (2006–2015). Patients < 20 years and pacemaker/implantable
cardioverter defibrillator procedures excluded.
Fig. 7 Urgency categories (2006 vs. 2015). Emergency = acutely life-threatening cardiac/vascular
disease.
Fig. 8 Isolated mitral valve surgery (2006–2015).
Fig. 9 Age distribution for congenital heart surgery (2006–2015). Bias possible due to the
fact that not all relevant procedures can be allocated exactly to the congenital heart
disease category in patients older than 18 years (e.g., aortic valve disease).
Compared to previous years' data, several important developments continued to be almost
unchanged in 2015. The age distribution of patients ([Fig. 6]) shows again the shift to an elderly patient population, with presently 53.1% of
the cardiac procedures performed in patients aged at least 70 years and 14.8% in patients
aged 80 years or older. However, mortality remained on the same low level over the
represented decade ([Fig. 2]). The rate of CABG procedures decreased over the past years, whereas the relative
number of off-pump CABG procedures reached a level of 16.5% in 2015 as compared to
15.3% in 2014 ([Fig. 3]).
Since 2004, more than 50% of isolated mitral valve procedures have been reconstructions.
In 2015, mitral valve reconstruction could be achieved in 63.6% of the procedures
([Fig. 8]). Based on the fact that without exception all isolated mitral valve procedures
are included, regardless of the underlying valve disease concerning morphology or
urgency of operation, it has to be assumed that the relative rate of mitral valve
reconstruction would certainly be even higher if patients without possibility or indication
for reconstruction would have been excluded (e.g., mitral valve stenosis, calcifications,
or endocarditis). In other publications, for example by Gammie et al,[27] patients with mitral valve stenosis, endocarditis, and emergency procedures were
usually excluded. Therefore, the published rates of mitral valve repair have to be
interpreted with caution if compared with this registry.
The continued increase of left ventricular assist device implantations ([Fig. 10]) emphasizes the increasing relevance of mechanical circulatory support.
Fig. 10 Development of mechanical circulatory support (2006–2015).
Again, a remarkable trend is the still ongoing increase of TAVI procedures in Germany
([Fig. 5]), whereas the count of isolated aortic valve replacement procedures showed a slight
decrease of 4.9%. Starting in 2006 with just 78 implantations (0.67% of isolated aortic
valve procedures), in 2015, 9,813 (46.7%) TAVI were reported to the registry. It must
be emphasized that the 78 institutions which contribute their data to this registry
do not represent all departments performing TAVI in Germany. It is known that some
additional institutions in Germany perform TAVI procedures under different infrastructure
conditions and various external cooperations. This practice does not correlate to
the recommendations of the European guideline on the management of valvular heart
disease (version 2012).[28] In July 2015, the first version of the quality assurance directive for “minimally
invasive heart valve interventions (TAVI, mitral clip reconstruction),” in which obligatory
structures, defined processes, and qualified personnel are exactly specified, was
released by the German Federal Joint Committee (G-BA).
In addition to the registry data, the short-, mid-, and long-term results of the German
Aortic Valve Registry (GARY)[29]
[30]
[31]
[32]
[33] and the annual analyses of the legal quality assurance (§137 SGB V) are of outstanding
importance concerning the judgement of developments and quality - and thus for patient
benefit.
Discussion
The registry of the GSTCVS enables a comprehensive overview of all heart surgical
procedures performed in Germany in 2015. The accuracy of this registry is considered
to be high due to the implemented compilation algorithm using standardized operation
coding which is 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.[34] In continuation with previous years, it can be concluded that heart surgery in Germany
is performed on a constantly high level with very high inhospital survival rates of
patients compared with international registries. In addition, the registry data demonstrate
that the provision of heart surgery in Germany is appropriate and nationwide patient
treatment is guaranteed in a round-the-clock service (24/7/365). These conclusions
are especially important in the context of various activities in health care policy
and the demographic change of the German population leading to an increase of patient
age and related comorbidities resulting in higher preoperative risk profiles.
Compared to 2014, the number of cardiac surgery procedures remains on nearly the same
level due to the still increasing number of catheter-based heart valve procedures.
Further improvements in the basic configuration of the registry are recommended to
enable more detailed and particularly risk-adjusted data analyses. However, if significant
structural changes in data collection for the registry are conducted, it must be ensured
that data compatibility still allows further longitudinal data analysis.
Completeness, validity, and further developments will depend on continued efforts
of the GSTCVS in close collaboration with all cardiac surgical departments in Germany.
This will be of outstanding importance in the sense of a contribution for patient
safety and to adduce evidence for high quality of heart surgery in Germany.
Abbreviations
ASD:
atrial septal defect
CABG:
coronary artery bypass grafting
CHD:
congenital heart disease
DLTx:
double lung transplantation
DORV:
double outlet right ventricle
ECC:
extracorporeal circulation
HLTx:
heart-lung transplantation
HTx:
heart transplantation
ICD:
implantable cardioverter defibrillator
PDA:
patent ductus arteriosus
SLTx:
single lung transplantation
TAVI:
transcatheter aortic valve implantation
TGA:
transposition of the great arteries
TMLR:
transmyocardial laser revascularisation
Tx:
Organ transplantation
VSD:
ventricular septal defect