Christian-Alexander Behrendt

Variations in Abdominal Aortic Aneurysm Care: A Report from the International Consortium of Vascular Registries

Background: This project by the ICVR (International Consortium of Vascular Registries), a collaboration of 11 vascular surgical quality registries, was designed to evaluate international variation in the contemporary management of abdominal aortic aneurysm (AAA) with relation to recommended treatment guidelines from the Society for Vascular Surgery and the European Society for Vascular Surgery. Methods: Registry data for open and endovascular AAA repair (EVAR) during 2010 to 2013 were collected from 11 countries. Variations in patient selection and treatment were compared across countries and across centers within countries. Results: Among 51 153 patients, 86% were treated for intact AAA (iAAA) and 14% for ruptured AAA. Women constituted 18% of the entire cohort (range, 12% in Switzerland–21% in the United States; P<0.01). Intact AAAs were repaired at diameters smaller than recommended by guidelines in 31% of men (<5.5 cm; range, 6% in Iceland–41% in Germany; P<0.01) and 12% of women with iAAA (<5 cm; range, 0% in Iceland–16% in the United States; P<0.01). Overall, use of EVAR for iAAA varied from 28% in Hungary to 79% in the United States (P<0.01) and for ruptured AAA from 5% in Denmark to 52% in the United States (P<0.01). In addition to the between-country variations, significant variations were present between centers in each country in terms of EVAR use and rate of small AAA repair. Countries that more frequently treated small AAAs tended to use EVAR more frequently (trend: correlation coefficient, 0.51; P=0.14). Octogenarians made up 23% of all patients, ranging from 12% in Hungary to 29% in Australia (P<0.01). In countries with a fee-for-service reimbursement system (Australia, Germany, Switzerland, and the United States), the proportions of small AAA (33%) and octogenarians undergoing iAAA repair (25%) were higher compared with countries with a population-based reimbursement model (small AAA repair, 16%; octogenarians, 18%; P<0.01). In general, center-level variation within countries in the management of AAA was as important as variation between countries. Conclusions: Despite homogeneous guidelines from professional societies, significant variation exists in the management of AAA, most notably for iAAA diameter at repair, use of EVAR, and the treatment of elderly patients. ICVR provides an opportunity to study treatment variation across countries and to encourage optimal practice by sharing these results.

Registry and health insurance claims data in vascular research and quality improvement

The expansion of procedures in multidisciplinary vascular medicine has sparked a controversy regarding measures of quality improvement. In addition to primary registries, the use of health insurance claims data is becoming of increasing importance. However, due to the fact that health insurance claims data are not collected for scientific evaluation but rather for reimbursement purposes, meticulous validation is necessary before and during usage in research and quality improvement matters. This review highlights the advantages and disadvantages of such data sources. A recent comprehensive expert opinion panel examined the use of health insurance claims data and other administrative data sources in medicine. Results from several studies concerning the validity of administrative data varied significantly. Validity of these data sources depends on the clinical relevance of the diagnoses considered. The rate of implausible information was 0.04 %, while the validity of the considered diagnoses varied between 80 and 97 % across multiple validation studies. A matching study between health insurance claims data of the third-largest German health insurance provider, DAK-Gesundheit, and a prospective primary registry of the German Society for Vascular Surgery demonstrated a good level of validity regarding the mortality of endovascular and open surgical treatment of abdominal aortic aneurysm in German hospitals. In addition, a large-scale international comparison of administrative data for the same disorder presented important results in treatment reality, which differed from those from earlier randomized controlled trials. The importance of administrative data for research and quality improvement will continue to increase in the future. When discussing the internal and external validity of this data source, one has to distinguish not only between its intended usage (research vs. quality improvement), but also between the included diseases and/or treatment procedures. Linkage between primary registry data and administrative data could be a reasonable solution to some current major issues of validity.
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Short-term and long-term results of endovascular and open repair of abdominal aortic aneurysms in Germany

Background: Endovascular aortic repair (EVAR) has emerged as a standard of care for abdominal aortic aneurysm (AAA) repair. However, real‐world evidence to compare this technology to open aortic repair (OAR) is limited. Major gaps exist related to long‐term outcomes of therapies worldwide. Methods: Health insurance claims data of Germanys third largest insurance provider, DAK‐Gesundheit, were used to determine outcomes after interventions for intact AAA (iAAA) and ruptured AAA (rAAA). The study included patients operated on between October 2008 and April 2015. Results: Included were 5509 patients (3627 EVAR and 1859 OAR). Median follow‐up was 2.44 years (range, 0–6.46 years). The in‐hospital mortality was lower after EVAR compared with OAR for both iAAA (1.2% vs 5.4%) and rAAA (26.1% vs 42%; P < .001). Postoperative length of stay and occurrence of complications were also lower after EVAR. The in‐hospital mortality benefits of EVAR were most prominent in octogenarians (iAAA: EVAR, 2.2%; OAR, 18.2%; rAAA: EVAR, 34.4%; OAR, 62.3%; P < .001). However, the early survival benefit after EVAR reversed at ˜1.5 years, and Cox proportional hazard models revealed no differences in overall survival between EVAR and OAR. Landmark analysis focusing on patients surviving the procedure has shown lower survival in patients with EVAR. Conclusions: In this largest European investigation to date using health insurance claims data, we found that in‐hospital outcomes in Germany favor EVAR, which is comparable to findings reported in the United States and the United Kingdom. Trends toward lower long‐term survival after EVAR after discharge are important and require future research and reflection.

IDOMENEO – Ist die Versorgungsrealität in der Gefäßmedizin Leitlinien- und Versorgungsgerecht?

ZusammenfassungDie Prävalenz der peripheren arteriellen Verschlusskrankheit (PAVK) und der Anteil endovaskulärer Verfahren zu deren Therapie nimmt weltweit zu. Für viele Behandlungsfälle oder Verfahren stehen bisher keine randomisierten kontrollierten Studien (RCT) oder Ergebnisse aus Metaanalysen zur Verfügung. Die Therapieentscheidung und Wahl des Verfahrens bleiben daher nicht selten der persönlichen Expertise des Behandlers überlassen. Die IDOMENEO-Studie stellt ein mehrstufiges multimethodales Projekt zur Versorgungsforschung und Qualitätssicherung in der interdisziplinären Gefäßmedizin dar, das sich umfassend mit dieser Thematik auseinandersetzen wird. Hierbei werden verschiedene Methoden und Datenquellen (auch Routinedaten) sinnvoll miteinander verknüpft. Wesentliche Bestandteile des Gesamtkonzepts sind die Implementierung einer datenschutzkonformen und datensicheren Registerplattform (GermanVasc) sowie die Entwicklung von Instrumenten zur validen Messung der Lebensqualität von PAVK-Patienten. Die datenschutzkonforme Verknüpfung von Primärdaten des Registers und Routinedaten des Konsortialpartners BARMER soll zudem eine Validierung der Datenquellen ermöglichen.AbstractThe prevalence of peripheral arterial occlusive disease (PAOD) and the proportion of endovascular procedures for treatment are increasing worldwide. For many cases of treatment or procedures no randomized controlled trials (RCT) or results from meta-analyses are so far available. The decision for treatment and selection of procedure is therefore not uncommonly left up to the personal expertise of the physician. The IDOMENEO study represents a multistage multimethodological project for healthcare research and quality assurance in interdisciplinary vascular medicine, which undertakes a comprehensive examination of this topic. Various methods and data sources (even routine data) are linked in a meaningful way. The essential components of the total project are implementation of a register platform (GermanVasc), which conforms to data protection and data security as well as the development of instruments for valid measurement of the quality of life of patients with PAOD. The data protection-conform linking of primary data in the register and routine data of the consortium partner BARMER should also enable validation of the data sources.

Gender differences in endovascular treatment of infrainguinal peripheral artery disease

BACKGROUND Despite ongoing research concerning comorbidities and clinical presentation of peripheral arterial disease (PAD), the issue of gender associated differences in treatment is far from being settled. PATIENTS AND METHODS This was a prospective, non-randomized multicentre study design. All patients suffering from intermittent claudication (IC) or critical limb ischaemia (CLI) were included. RESULTS A total of 2,798 procedures for symptomatic PAD in the infrainguinal region were recorded, with 1,696 (61.4 %) males. Distribution of comorbidities for patients with IC were gender-specifically different. Smoking was more common in men (41.9 vs. 31.9 %, p < .001), men had more often previous coronary heart disease (35.2 vs. 27.7 %, p = .007), and suffered more often from diabetes (33.9 vs. 28.2 %, p = .037). Women were generally older (71 vs. 77 years). Men were more prone to present with IC (46.9 vs. 43.6 %, p < .001) and ulcer/gangrene (43.6 vs. 41.2 %, p < .001). Women were more likely to present with rest pain (9.5 vs. 15.1 %, p < .001). Men were more often treated for a lesion below the knee (BTK) (21.1 vs. 14.9 %, p < .001), and females above the knee (ATK) (58.1 vs. 61.5 %, p < .001). Logistic regression analysis revealed a significant association of male gender and treatment for lesions BTK (OR 1.565, 95 % CI 1.281-1.913, p < .001). Dissections and bleeding complications were more often observed in females with IC (3.3 vs. 7.2 %, p = 0.003; 0.4 vs. 1.5 %, p = 0.044). Women were rather discharged to rehabilitation and had a longer hospital stay compared to men (3.4 vs. 8.9 %, p < .001; three vs. four days, p = .023). CONCLUSIONS The present study provides an overview on gender-specific differences in endovascular treatment of PAD. To date, available evidence on this topic is limited, emphasising the importance of further vascular research targeting this topic.

Gender differences in abdominal aortic aneurysms in Germany using health insurance claims data

BACKGROUND Endovascular aortic repair (EVAR) has emerged as standard of care for abdominal aortic aneurysm (AAA). Real-world evidence is limited to compare this technology to open repair (OAR). Major gaps exist related to short-term and long-term outcomes, particularly in respect of gender differences. MATERIALS AND METHODS Health insurance claims data from Germanys third largest insurance provider, DAK-Gesundheit, was used to investigate invasive in-hospital treatment of intact (iAAA) and ruptured AAA (rAAA). Patients operated between October 2008 and April 2015 were included in the study. RESULTS A total of 5,509 patients (4,966 iAAA and 543 rAAA) underwent EVAR or OAR with a median follow-up of 2.44 years. Baseline demographics, comorbidities, and clinical characteristics of DAK-G patients were assessed. In total, 84.6 % of the iAAA and 79.9 % of the rAAA were male. Concerning iAAA repair, the median age (74 vs. 73 years, p < .001) compared to men was higher in females, but their EVAR-rate (66.8 % vs. 71.1 %, p = .018) was lower. Besides higher age of female patients (80 vs. 75 years, p < .001), no further statistically significant differences were seen following rAAA repair. In-hospital mortality was slightly lower in males compared to females following iAAA (2.3 % vs. 3.1 %, p = .159) and rAAA (37.3 % vs. 43.1 %, p = .273) repair. Concerning iAAA repair, a higher rate of female patients was transferred to another hospital (3.7 % vs. 2.0 %, p = 0.008) or discharged to rehabilitation (6.0 % vs. 2.7 %, p < .001) compared to male patients. CONCLUSIONS In this large German claims data cohort, women are generally older and more often transferred to another hospital or discharged to rehab following iAAA repair. Nonetheless, no significantly increased risk of in-hospital or late death appeared for women in multivariate analyses. Further studies are necessary to evaluate the impact of recent gender-specific treatment strategies on overall outcome under real-world settings.

Perioperative Letalität bei der Versorgung abdomineller Aortenaneurysmen in Deutschland

OBJECTIVE This study determined whether the routine data of a single health insurance company (DAK health) can allow equivalent statements on hospital mortality of endovascular (EVAR) and open (OR) repair of intact (iAAA) and ruptured (rAAA) aortic aneurysms (AAA) in Germany in comparison to clinical registry surveys of the German Vascular Society (GVS). METHODS The study compared two cohorts that were comparable in group sizes but not identical in terms of the duration of treatment and the selection of the centers. The GVS registry included 5080 patients with iAAA and 485 with rAAA and the DAK data consisted of 5182 patients with iAAA and 576 with rAAA. In GVS (in brackets DAK) 72.6 % (71.0 %) of patients with iAAA received EVAR and 27.4 % (29 %) OR, with rAAA 34.6 % (26.9 %) of patients received EVAR and 65.4 % (73.1 %) OR. Both cohorts were comparable with respect to patient age and gender distribution. RESULTS Intact AAA: the hospital mortality rate in GVS (DAK in brackets) was 0.95 % (1.4 %) with EVAR and 4.7 % (5.5 %) with OR. For patients less than 80 years old the statements were almost identical when the hospital mortality in the GVS and DAK registers constituted 0.85 % and 0.9 % after EVAR and 3.8 % and 4.0 % after OR, respectively. Patients over 80 years old in particular had a benefit by EVAR as the hospital mortality in GVS (DAK in brackets) was 1.3 % (2.6 %) with EVAR vs. 13.9 % (17.4 %) with OR. A benefit by EVAR was also seen in women. Ruptured AAA: the hospital mortality rate in GVS (DAK in brackets) was 19.6 % (27.1 %) with EVAR and 38.5 % (42.0 %) with OR. Again, particularly patients over 80 years old showed an advantage with EVAR where the hospital mortality was 31.0 % (34.3 %) with EVAR vs. 56.7 % (61.3 %) with OR in this group. CONCLUSION Hospital mortality is an important quality parameter of endovascular and open repair of iAAA and rAAA. Administrative data of a health insurance company can be used to provide representative and comprehensive statements on inhospital mortality.

[Perioperative mortality following repair for abdominal aortic aneurysm in Germany : Comparison of administrative data of the DAK health insurance and clinical registry data of the German Vascular Society].

OBJECTIVE This study determined whether the routine data of a single health insurance company (DAK health) can allow equivalent statements on hospital mortality of endovascular (EVAR) and open (OR) repair of intact (iAAA) and ruptured (rAAA) aortic aneurysms (AAA) in Germany in comparison to clinical registry surveys of the German Vascular Society (GVS). METHODS The study compared two cohorts that were comparable in group sizes but not identical in terms of the duration of treatment and the selection of the centers. The GVS registry included 5080 patients with iAAA and 485 with rAAA and the DAK data consisted of 5182 patients with iAAA and 576 with rAAA. In GVS (in brackets DAK) 72.6 % (71.0 %) of patients with iAAA received EVAR and 27.4 % (29 %) OR, with rAAA 34.6 % (26.9 %) of patients received EVAR and 65.4 % (73.1 %) OR. Both cohorts were comparable with respect to patient age and gender distribution. RESULTS Intact AAA: the hospital mortality rate in GVS (DAK in brackets) was 0.95 % (1.4 %) with EVAR and 4.7 % (5.5 %) with OR. For patients less than 80 years old the statements were almost identical when the hospital mortality in the GVS and DAK registers constituted 0.85 % and 0.9 % after EVAR and 3.8 % and 4.0 % after OR, respectively. Patients over 80 years old in particular had a benefit by EVAR as the hospital mortality in GVS (DAK in brackets) was 1.3 % (2.6 %) with EVAR vs. 13.9 % (17.4 %) with OR. A benefit by EVAR was also seen in women. Ruptured AAA: the hospital mortality rate in GVS (DAK in brackets) was 19.6 % (27.1 %) with EVAR and 38.5 % (42.0 %) with OR. Again, particularly patients over 80 years old showed an advantage with EVAR where the hospital mortality was 31.0 % (34.3 %) with EVAR vs. 56.7 % (61.3 %) with OR in this group. CONCLUSION Hospital mortality is an important quality parameter of endovascular and open repair of iAAA and rAAA. Administrative data of a health insurance company can be used to provide representative and comprehensive statements on inhospital mortality.

Indicators of outcome quality in peripheral arterial disease revascularisations – a Delphi expert consensus

INTRODUCTION Peripheral arterial disease (PAD) affects a continuously increasing number of people worldwide leading to more invasive treatments. Indication to perform invasive revascularisations usually arises from consensus-based recommendations of practice guidelines and from few randomized controlled trials where outcome measures focus mainly on risk factors associated with mortality and morbidity. To date, no broad consensual agreement of experts on valid indicators of outcome quality exists for PAD. METHODS A literature review was conducted to collect indicators of outcome quality from studies of PAD. The Delphi technique was used to achieve a consensual agreement on a set of core indicators. The expert panel of the two-round Delphi approach was formed by leading vascular specialists joining the IDOMENEO study, physician assistants, wound nurses, and patient representatives. Items were scored via a web-based anonymised electronic questionnaire using a five-point Likert-scale. RESULTS Out of 40 invited experts 30 joined the panel and completed round one. Twenty-four experts completed the second and final round. Forty-three indicators of outcome quality were initially identified and validated by the panel. After two Delphi rounds, 12 indicators (27.9 %) achieved the limit of agreement for relevance and four (9.3 %) for practicability. Major adverse limb events (MALE), major amputation, and major re-intervention (or re-operation) were consented as both highly relevant and practicable. Additionally, major adverse cardiovascular events (MACE), myocardial infarction, stroke or transient ischaemic attack, all-cause death, all re-intervention (or re-operation), wound infection, vascular access-related major complication, walking distance, and Rutherford-classification were consented as highly relevant. Ankle-brachial-index was consented as highly practicable. CONCLUSIONS This Delphi approach of vascular experts identified three indicators as highly relevant and clinically practicable to be recommended as indicators of outcome quality in invasive PAD treatment. Among others, these consented items may help in harmonising future studies and quality benchmarking increasing their comparability, validity, and efficiency.

The Strengths and Limitations of Claims Based Research in Countries With Fee for Service Reimbursement

The Strengths and Limitations of Claims Based Research in Countries With Fee for Service Reimbursement