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DOI: 10.1055/s-0036-1592124
German Heart Surgery Report 2015: The Annual Updated Registry of the German Society for Thoracic and Cardiovascular Surgery
Address for correspondence
Publication History
09 August 2016
22 August 2016
Publication Date:
01 September 2016 (online)
Abstract
On the basis of a long-standing voluntary registry, which was founded by the German Society for Thoracic and Cardiovascular Surgery (GSTCVS), well-defined data of all heart, thoracic, and vascular surgery procedures performed in 78 German heart surgery departments during 2015 are analyzed. In 2015, a total of 103,967 heart surgery procedures (implantable cardioverter defibrillator, pacemaker, and extracardiac procedures without ECC excluded) were submitted to the database. Approximately 14.8% of the patients were at least 80 years old, resulting in an increase of 0.6% compared with the data of 2014. For 38,601 isolated coronary artery bypass grafting procedures (relationship on-/off-pump: 5:1), the unadjusted inhospital mortality was 2.7%. Concerning the 32,346 isolated heart valve procedures (including 10,606 catheter-based implantations) an unadjusted inhospital mortality of 4.4% was observed.
This annual updated registry of the GSTCVS represents voluntary public reporting by accumulating actual information for nearly all heart surgical procedures in Germany, demonstrates advancements in heart medicine, and enables internal/external quality assurance for all participants. In addition, the registry demonstrates that the provision of heart surgery in Germany is appropriate and patients are treated nationwide in a round-the-clock service.
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Keywords
heart surgery - outcome - registry - quality assurance - congenital heart disease - aortic surgery - transplantationIntroduction
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.
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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.
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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.
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.
Note: Pacemaker/ implantable cardioverter defibrillator and extracardiac surgery without extracorporeal circulation excluded.
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.
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.
Procedures |
2015 |
2014 |
||
---|---|---|---|---|
N |
% |
N |
% |
|
Emergency |
12,843 |
12.4% |
12,583 |
12.0% |
Redo |
8,994 |
8.7% |
8,809 |
8.4% |
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.
Note: Apical aortic conduits procedures (n = 4) excluded.
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 |
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 |
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.
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%.
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.
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.
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.
Note: 496 procedures unspecified with regard to endocardiac/epicardiac ablation.
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.
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.
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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.
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Abbreviations
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Acknowledgments
On behalf of the German Society for Thoracic and Cardiovascular Surgery, the authors would like to thank the heads of the departments and their employees of all cardiac surgery units in Germany for their continued cooperation and support to realize this registry.
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References
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Address for correspondence
-
References
- 1 Kalmar P, Irrgang E. Cardiac surgery in the Federal Republic of Germany during 1989. A report by the German Society for Thoracic and Cardiovascular Surgery. Thorac Cardiovasc Surg 1990; 38 (3) 198-200
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