Klinikum St. Marien Amberg

Quality results

Treatment sector: Defibrillator (shock generator) for the treatment of cardiac arrhythmias: first implantation (HSMDEF-DEFI-IMPL)

Information about this treatment area (documentation)

Designation	Implantierbare Defibrillatoren – Implantation
Shortcut	09/4
Number of cases	35
Documentation rate	102.9 %

Summary result:

In 9 of 9 quality characteristics, the quality objective was achieved.
No assessment is possible for any quality characteristic

Number of patients treated: 35

Quality objective achieved
Quality objective not achieved

The results in detail

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Quality criterion

Hospital result
and target area

Quality objective
achieved?

All information

Ratio of actual to expected number of patients in whom the scientifically recommended maximum radiation exposure was exceeded when a defibrillator was inserted for the first time.

National result: 0,72
Hospital: 0,00

Target area: at most 2,35

Quality objective achieved

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This is how rarely complications occurred during initial defibrillator insertion (other than probe malfunction or displacement: including wound infections)

National result: 0,87 %
Hospital: Data protection

No information due to data protection

Target area: at most 2,50 %

Quality objective achieved
Why?

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This is how often the probes were advanced through the subclavian vein to the heart when a defibrillator was first inserted

National result: 50,74 %
Hospital: 85,29 %

as often as possible

Evaluation is not available

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Ratio of actual to expected number of patients who experienced tube or pouch problems related to the insertion of a shock generator and resulted in a repeat surgery within one year.

National result: 1,00
Hospital: 1,64

Target area: at most 2,65

Quality objective achieved

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Ratio of actual to expected number of patients who had infections or perforations of the casing through the skin associated with the insertion of a shock generator, leading to a repeat operation within one year.

National result: 1,00
Hospital: 0,00

Target area: at most 5,03

Quality objective achieved

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The shock generator (defibrillator system) was selected on the basis of recognised scientific recommendations

National result: 97,72 %
Hospital: 100,00 %

Target area: at least 90,00 %

Quality objective achieved

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Ratio of the actual number to the previously expected number of patients who died during their hospital stay (the individual risks of the patients were taken into account)

National result: 1,17
Hospital: 2,03

Target area: at most 6,48

Quality objective achieved

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Duration of the operation during which the shock generator (defibrillator) is first used or the housing is replaced

National result: 91,85 %
Hospital: 93,33 %

Target area: at least 60,00 %

Quality objective achieved

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Various measurements during the operation showed that the shock generator?s (defibrillator?s) wiring was functioning properly

National result: 96,17 %
Hospital: 98,00 %

Target area: at least 90,00 %

Quality objective achieved

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This is how rarely displacements or malfunctions of probes occurred during or after insertion of the defibrillator

National result: 0,89 %
Hospital: 0,00 %

Target area: at most 3,00 %

Quality objective achieved

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Code ID	131801
Result	0,00
Evaluation through structured dialogue	The result is in the target area - the quality target is therefore considered to have been fully achieved. (R10)
Population	34
Events observed	0
Anticipated events	3,55
Result trend compared with the previous reporting year	eingeschränkt/nicht vergleichbar
Comparison with the previous reporting year	unverändert
National result	0,72
Target range (reference range)	<= 2,35 (95. Perzentil)
Confidence interval nationwide	0,69 - 0,76
Hospital confidence interval	0,00 - 0,97
Reference infection	No
Type of value	QI
Relation to the procedure	DeQS
Reference to other QA results
Sorting
Risk-adjusted rate
Comments/explanations by the competent authority at national or state level
Comments/explanations by the hospital
Specialist note IQTIG Risk adjustment aims to compensate for the different patient structures in different facilities. Ideally, this leads to a fair comparison of the different facilities, since patients have individual risk factors (such as concomitant diseases) that systematically influence the quality outcome, without one facility being held responsible for, for example, more frequent complications as a result. With the help of risk adjustment, the quality outcome of, for example, a facility with many high-risk cases can be statistically compared more fairly with the quality outcome of a facility with many low-risk cases. More information on risk adjustment can be found at the following link: https://iqtig.org/das-iqtig/grundlagen/methodische-grundlagen. The reference range indicates the results at which a facility can be assumed to provide good quality of care, although deviations are possible. The reference range thus sets a benchmark for the assessment of facilities. A result outside the reference range is initially considered conspicuous. This usually entails an analysis by means of a statement procedure. It should be noted that a quality result outside the reference range is not synonymous with a lack of quality of the facility in the quality aspect considered here. The deviation can also be due, for example, to faulty documentation, medical specificity of the patient collective or individual cases. The assessment of quality is carried out within the framework of the defined procedure in the comments procedure. More information on reference areas can be found at the following link: https://iqtig.org/das-iqtig/grundlagen/methodische-grundlagen.

Code ID	131802
Result (%)	Data protection
Evaluation through structured dialogue	Although the result is not in the target area, the quality target is still considered to have been achieved. For more information, see All information (click here) at the bottom under Comment or Technical note. (H99)
Population	Data protection
Events observed	Data protection
Anticipated events	Data protection
Result trend compared with the previous reporting year	eingeschränkt/nicht vergleichbar
Comparison with the previous reporting year	eingeschränkt/nicht vergleichbar
National result (%)	0,87
Target range (reference range)	<= 2,50 %
Confidence interval nationwide (%)	0,75 - 1,01
Hospital confidence interval (%)	0,00 - 0,00
Reference infection	No
Type of value	QI
Relation to the procedure	DeQS
Reference to other QA results
Sorting
Risk-adjusted rate
Comments/explanations by the competent authority at national or state level	Der Leistungserbringer wurde auf das rechnerisch auffällige Ergebnis hingewiesen und zur internen Analyse der rechnerischen Auffälligkeit aufgefordert.
Comments/explanations by the hospital
Specialist note IQTIG The reference range indicates the results at which a facility can be assumed to provide good quality of care, although deviations are possible. The reference range thus sets a benchmark for the assessment of facilities. A result outside the reference range is initially considered conspicuous. This usually entails an analysis by means of a statement procedure. It should be noted that a quality result outside the reference range is not synonymous with a lack of quality of the facility in the quality aspect considered here. The deviation can also be due, for example, to faulty documentation, medical specificity of the patient collective or individual cases. The assessment of quality is carried out within the framework of the defined procedure in the comments procedure. More information on reference areas can be found at the following link: https://iqtig.org/das-iqtig/grundlagen/methodische-grundlagen.

Code ID	131803
Result (%)	85,29
Evaluation through structured dialogue
Population	34
Events observed	29
Anticipated events	0,00
Result trend compared with the previous reporting year
Comparison with the previous reporting year
National result (%)	50,74
Target range (reference range)
Confidence interval nationwide (%)	50,03 - 51,46
Hospital confidence interval (%)	69,87 - 93,55
Reference infection	No
Type of value	TKez
Relation to the procedure	DeQS
Reference to other QA results
Sorting
Risk-adjusted rate
Comments/explanations by the competent authority at national or state level
Comments/explanations by the hospital
Specialist note IQTIG Although indicators represent quality, their results do not allow a direct assessment of the quality of care (due to the lack of a reference range) and they are not suitable for direct quality comparisons (due to the lack of mathematical adjustment). However, they are usually published in direct connection with a quality indicator, the result of which is supplemented by the indicator values (imputed and supplementary indicators). They thus contribute to an increase in the comprehensibility of the quality results. The transparency indicators, which are to be distinguished from these, represent aspects of care for which there are no quality indicators, but which are nevertheless important for the presentation of the quality of care. More detailed information on indicators can be found at the following link: https://iqtig.org/veroeffentlichungen/kennzahlenkonzept.

Code ID	132001
Result	1,64
Evaluation through structured dialogue	The result is in the target area - the quality target is therefore considered to have been fully achieved. (R10)
Population	Data protection
Events observed	Data protection
Anticipated events	Data protection
Result trend compared with the previous reporting year	eingeschränkt/nicht vergleichbar
Comparison with the previous reporting year	eingeschränkt/nicht vergleichbar
National result	1,00
Target range (reference range)	<= 2,65 (95. Perzentil)
Confidence interval nationwide	0,92 - 1,08
Hospital confidence interval	0,09 - 7,23
Reference infection	No
Type of value	QI
Relation to the procedure	DeQS
Reference to other QA results
Sorting
Risk-adjusted rate
Comments/explanations by the competent authority at national or state level
Comments/explanations by the hospital
Specialist note IQTIG The aim of risk adjustment is to balance out the different patient structures in different facilities. Ideally, this leads to a fair comparison of the different facilities, as patients have individual risk factors (such as concomitant diseases) that systematically influence the quality result without one facility being responsible for, for example, more frequent complications as a result. With the help of risk adjustment, the quality result of a facility with many high-risk cases, for example, can be statistically compared more fairly with the quality result of a facility with many low-risk cases. Further information on risk adjustment can be found at the following link: https://iqtig.org/das-iqtig/wie-wir- arbeiten/grundlagen/standard-titel/. The reference range indicates the results at which a facility can be assumed to provide good quality of care, although deviations are possible. The reference range thus defines a benchmark for the evaluation of facilities. A result outside the reference range is initially considered conspicuous. This usually results in an analysis by means of a statement procedure. It should be noted that a quality result outside the reference range is not synonymous with a lack of quality of the facility in the quality aspect under consideration here. The deviation may also be due, for example, to incorrect documentation, special medical features of the patient population or individual cases. The assessment of quality is carried out within the framework of the defined procedure in the statement procedure. Further information on reference areas can be found at the following link: https://iqtig.org/das-iqtig/wie-wir-arbeiten/grundlagen/standard- titel/. This indicator includes both events that occur before discharge from hospital and events that occur after discharge but can still be linked to the implantation.

Code ID	132002
Result	0,00
Evaluation through structured dialogue	The result is in the target area - the quality target is therefore considered to have been fully achieved. (R10)
Population	17
Events observed	0
Anticipated events	0,00
Result trend compared with the previous reporting year	eingeschränkt/nicht vergleichbar
Comparison with the previous reporting year	eingeschränkt/nicht vergleichbar
National result	1,00
Target range (reference range)	<= 5,03 (95. Perzentil)
Confidence interval nationwide	0,82 - 1,20
Hospital confidence interval	0,00 - 35,22
Reference infection	No
Type of value	QI
Relation to the procedure	DeQS
Reference to other QA results
Sorting
Risk-adjusted rate
Comments/explanations by the competent authority at national or state level
Comments/explanations by the hospital
Specialist note IQTIG The aim of risk adjustment is to balance out the different patient structures in different facilities. Ideally, this leads to a fair comparison of the different facilities, as patients have individual risk factors (such as concomitant diseases) that systematically influence the quality result without one facility being responsible for, for example, more frequent complications as a result. With the help of risk adjustment, the quality result of a facility with many high-risk cases, for example, can be statistically compared more fairly with the quality result of a facility with many low-risk cases. Further information on risk adjustment can be found at the following link: https://iqtig.org/das-iqtig/wie-wir- arbeiten/grundlagen/standard-titel/. The reference range indicates the results at which a facility can be assumed to provide good quality of care, although deviations are possible. The reference range thus defines a benchmark for the evaluation of facilities. A result outside the reference range is initially considered conspicuous. This usually results in an analysis by means of a statement procedure. It should be noted that a quality result outside the reference range is not synonymous with a lack of quality of the facility in the quality aspect under consideration here. The deviation may also be due, for example, to incorrect documentation, special medical features of the patient population or individual cases. The assessment of quality is carried out within the framework of the defined procedure in the statement procedure. Further information on reference areas can be found at the following link: https://iqtig.org/das-iqtig/wie-wir-arbeiten/grundlagen/standard- titel/. This indicator includes both events that occur before discharge from hospital and events that occur after discharge but can still be linked to the implantation.

Code ID	50005
Result (%)	100,00
Evaluation through structured dialogue	The result is in the target area - the quality target is therefore considered to have been fully achieved. (R10)
Population	36
Events observed	36
Anticipated events	0,00
Result trend compared with the previous reporting year	eingeschränkt/nicht vergleichbar
Comparison with the previous reporting year	unverändert
National result (%)	97,72
Target range (reference range)	>= 90,00 %
Confidence interval nationwide (%)	97,50 - 97,92
Hospital confidence interval (%)	90,36 - 100,00
Reference infection	No
Type of value	QI
Relation to the procedure	DeQS
Reference to other QA results
Sorting
Risk-adjusted rate
Comments/explanations by the competent authority at national or state level
Comments/explanations by the hospital
Specialist note IQTIG The reference range indicates the results at which a facility can be assumed to provide good quality of care, although deviations are possible. The reference range thus sets a benchmark for the assessment of facilities. A result outside the reference range is initially considered conspicuous. This usually entails an analysis by means of a statement procedure. It should be noted that a quality result outside the reference range is not synonymous with a lack of quality of the facility in the quality aspect considered here. The deviation can also be due, for example, to faulty documentation, medical specificity of the patient collective or individual cases. The assessment of quality is carried out within the framework of the defined procedure in the comments procedure. Further information on reference ranges can be found under the following link: https://iqtig.org/das-iqtig/grundlagen/methodische-grundlagen. The choice of system for defibrillator implantation is assessed according to the current guidelines on pacemaker and cardiac resynchronisation therapy, on the diagnosis and treatment of heart failure, and on the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death of the European Society of Cardiology (Brignole et al. 2013, Glikson et al. 2021, McDonagh 2021, Priori et al. 2015). In individual cases, there may be justified deviations from the guidelines if defibrillators are implanted, e.g. as part of studies or when testing new procedures. - Brignole, M: Auricchio, A: Baron-Esquivias, G: Bordachar, P: Boriani, G: Breithardt, O-A: et al. (2013): 2013 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. Eu ropean Heart Journal 34(29): 2281-2329. DOI: 10.1093/eu rheartj/eht150. - Glikson, M: Nielsen, JC: Kronborg, MB: Michowitz, Y: Auric chio, A: Barbash, IM: et al. (2021): 2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. Euro pean Heart Journal 42(35): 3427-3520. DOI: 10.1093/eurhe artj/ehab364. - McDonagh, TA: Metra, M: Adamo, M: Gardner, RS: Baum bach, A: Böhm, M: et al. (2021): 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. European Heart Journal 42(36): 3599-3726. DOI: 10.1093/eu rheartj/ehab368. - Priori, SG: Blomström-Lundqvist, C: Mazzanti, A: Blom, N: Borggrefe, M: Camm, J: et al. (2015): 2015 ESC Guidelines for the management of patients with ventricular arrhythmias.

Code ID	51186
Result	2,03
Evaluation through structured dialogue	The result is in the target area - the quality target is therefore considered to have been fully achieved. (R10)
Population	Data protection
Events observed	Data protection
Anticipated events	Data protection
Result trend compared with the previous reporting year	eingeschränkt/nicht vergleichbar
Comparison with the previous reporting year	unverändert
National result	1,17
Target range (reference range)	<= 6,48 (95. Perzentil)
Confidence interval nationwide	0,99 - 1,38
Hospital confidence interval	0,36 - 10,33
Reference infection	No
Type of value	QI
Relation to the procedure	DeQS
Reference to other QA results
Sorting
Risk-adjusted rate
Comments/explanations by the competent authority at national or state level
Comments/explanations by the hospital
Specialist note IQTIG This indicator is a risk-adjusted indicator. A risk adjustment compensates for the different composition of the patient groups from different institutions. This leads to a fairer comparison, since there are patient-related risk factors (such as comorbidities) that systematically influence the indicator result without an institution being responsible for e.g. the following more frequent complications can be attributed. For example, the indicator result of a facility with many high-risk cases can be compared more statistically with the result of a facility with many low-risk cases. The risk factors are compiled from patient characteristics that were classified as risk-relevant as part of the development of quality indicators and which can be practically documented. The reference range indicates the range in which the results of an indicator are assessed as normal. A facility with a result outside the reference range is initially noticeable in terms of calculation, which usually results in an analysis in the structured dialog. It should be noted that an indicator result outside the reference range is not synonymous with a poor quality of the facility in the quality aspect considered here. The deviation can also e.g. be traceable to incorrect documentation or to individual cases. Quality is assessed in the context of the structured dialogue with the institutions. The results of this quality indicator can only be compared with the previous year's results to a limited extent due to adjustments to the calculation rule of the indicator. Further information on the adjustments made can be found in the description of the quality indicators at the following link: https://iqtig.org/qs-verfahren/.

Code ID	52131
Result (%)	93,33
Evaluation through structured dialogue	The result is in the target area - the quality target is therefore considered to have been fully achieved. (R10)
Population	45
Events observed	42
Anticipated events	0,00
Result trend compared with the previous reporting year	eingeschränkt/nicht vergleichbar
Comparison with the previous reporting year	unverändert
National result (%)	91,85
Target range (reference range)	>= 60,00 %
Confidence interval nationwide (%)	91,53 - 92,16
Hospital confidence interval (%)	82,14 - 97,71
Reference infection	No
Type of value	QI
Relation to the procedure	DeQS
Reference to other QA results
Sorting
Risk-adjusted rate
Comments/explanations by the competent authority at national or state level
Comments/explanations by the hospital
Specialist note IQTIG The reference range indicates the range in which the results of an indicator are assessed as normal. A facility with a result outside the reference range is initially noticeable in terms of calculation, which usually results in an analysis in the structured dialog. It should be noted that an indicator result outside the reference range is not synonymous with a poor quality of the facility in the quality aspect considered here. The deviation can also e.g. be traceable to incorrect documentation or to individual cases. Quality is assessed in the context of the structured dialogue with the institutions.

Code ID	52316
Result (%)	98,00
Evaluation through structured dialogue	The result is in the target area - the quality target is therefore considered to have been fully achieved. (R10)
Population	100
Events observed	98
Anticipated events	0,00
Result trend compared with the previous reporting year	eingeschränkt/nicht vergleichbar
Comparison with the previous reporting year	unverändert
National result (%)	96,17
Target range (reference range)	>= 90,00 %
Confidence interval nationwide (%)	96,02 - 96,31
Hospital confidence interval (%)	93,00 - 99,45
Reference infection	No
Type of value	QI
Relation to the procedure	DeQS
Reference to other QA results
Sorting
Risk-adjusted rate
Comments/explanations by the competent authority at national or state level
Comments/explanations by the hospital
Specialist note IQTIG It should be noted that this computational result may not be influenced exclusively by the respective institution. So e.g. the severity of illness or concomitant illnesses of the patients have an influence on the result. This indicator is a so-called quality index. This means that several measurements are evaluated per treatment case and that not only cases with a defibrillator implantation but also cases with a revision, a system change or an explantation of the defibrillator are considered. The aim is to consider an increased number of measurements and thus to reduce the number of cases prevalence problem (Heller 2010). If the number of cases is low at the site level, there is a risk that computational abnormalities arise systematically (randomly) from a few individual cases. The reference range indicates the range in which the results of an indicator are assessed as normal. A facility with a result outside the reference range is initially noticeable in terms of calculation, which usually results in an analysis in the structured dialog. It should be noted that an indicator result outside the reference range is not synonymous with a poor quality of the facility in the quality aspect considered here. The deviation can also e.g. be traceable to incorrect documentation or to individual cases. Quality is assessed in the context of the structured dialogue with the institutions. Heller, G (2010): Quality assurance with routine data - current status and further development. Chapter 14. In: Klauber, J: Geraedts, M: Friedrich, J: Hospital Report 2010: Focus: Hospital care in crisis? Stuttgart: Schattauer, 239-254. ISBN: 978-3794527267.

Code ID	52325
Result (%)	0,00
Evaluation through structured dialogue	The result is in the target area - the quality target is therefore considered to have been fully achieved. (R10)
Population	34
Events observed	0
Anticipated events	0,00
Result trend compared with the previous reporting year	eingeschränkt/nicht vergleichbar
Comparison with the previous reporting year	eingeschränkt/nicht vergleichbar
National result (%)	0,89
Target range (reference range)	<= 3,00 %
Confidence interval nationwide (%)	0,76 - 1,03
Hospital confidence interval (%)	0,00 - 10,15
Reference infection	No
Type of value	QI
Relation to the procedure	DeQS
Reference to other QA results
Sorting
Risk-adjusted rate
Comments/explanations by the competent authority at national or state level
Comments/explanations by the hospital
Specialist note IQTIG It should be noted that this computational result may not be influenced exclusively by the respective institution. So e.g. the severity of illness or concomitant illnesses of the patients have an influence on the result. The reference range indicates the range in which the results of an indicator are assessed as normal. A facility with a result outside the reference range is initially noticeable in terms of calculation, which usually results in an analysis in the structured dialog. It should be noted that an indicator result outside the reference range is not synonymous with a poor quality of the facility in the quality aspect considered here. The deviation can also e.g. be traceable to incorrect documentation or to individual cases. Quality is assessed in the context of the structured dialogue with the institutions.