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  • 1
    Online Resource
    Online Resource
    Rationale and methods of the IDOMENEO health outcomes of the peripheral arterial disease revascularisation study in the GermanVasc registry
    Hogrefe Publishing Group ; 2018
    In:  Vasa Vol. 47, No. 6 ( 2018-10-01), p. 499-505
    Details
    In: Vasa, Hogrefe Publishing Group, Vol. 47, No. 6 ( 2018-10-01), p. 499-505
    Abstract: Abstract. Background: Atherosclerotic disease of the lower extremity arteries (PAD) remains a significant burden on global healthcare systems with increasing prevalence. Various guidelines on the diagnosis and treatment of patients with PAD are available but they often lack a sufficient evidence base for high-grade recommendations since randomized and controlled trials (RCT) remain rare or are frequently subject to conflicts of interest. This registry trial aims to evaluate the outcomes of catheter-based endovascular revascularisations vs. open-surgical endarterectomy vs. bypass surgery for symptomatic PAD on medical and patient-reported outcomes. Methods and design: The study is a prospective non-randomized multicentre registry trial including invasive revascularisations performed in 10 000 patients treated for symptomatic PAD at 30 to 40 German vascular centres. All patients matching the inclusion criteria are consecutively included for a recruitment period of six months (between May and December 2018) or until 10 000 patients have been included in the study registry. There are three follow-up measures at three, six, and 12 months. Automated completeness and plausibility checks as well as independent site visit monitoring will be performed to assure high internal and external validity of the study data. Study endpoints include relevant major cardiovascular and limb events and patient-reported outcomes from two Delphi studies with experts in vascular medicine and registry-based research. Discussion: It remains unclear if results from RCT can reflect daily treatment practice. Furthermore, great costs and complexity make it challenging to accomplish high quality randomized trials in PAD treatment. Prospective registry-based studies to collect real-world evidence can help to overcome these limitations.
    Type of Medium: Online Resource
    ISSN: 0301-1526 , 1664-2872
    URL: Article
    DOI: 10.1024/0301-1526/a000730
    Language: English
    Publisher: Hogrefe Publishing Group
    Publication Date: 2018
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  • 2
    Online Resource
    Online Resource
    Long-term incidence of cancer after index treatment for symptomatic peripheral arterial disease – a health insurance claims data analysis
    Hogrefe Publishing Group ; 2020
    In:  Vasa Vol. 49, No. 6 ( 2020-10), p. 493-499
    Details
    In: Vasa, Hogrefe Publishing Group, Vol. 49, No. 6 ( 2020-10), p. 493-499
    Abstract: Summary: Background: Cancer as a concomitant condition in symptomatic peripheral arterial disease (PAD) patients could have an impact on further therapy and the long-term prognosis of these patients. Aim of this study was to investigate whether there is an increased incidence of cancer in PAD patients and to quantify the corresponding effect size. Materials and methods: Between January 1 st , 2008 and December 31 st , 2017, we analysed health insurance claims data from Germany’s second-largest insurance fund, BARMER. Symptomatic PAD patients suffering from intermittent claudication (IC) or chronic limb-threatening ischaemia (CLTI) were stratified by gender at index treatment. PAD patients were then followed until an incident cancer diagnosis was recorded. To adjust for age and gender, standardized incidence ratios (SIR) were computed using the 2012 German standard population as reference. Results: 96,528 PAD patients (47% female, 44% IC, mean age 72 years) were included in the current study. When compared to the overall population, female and male PAD patients have a significantly increased risk of incident cancer of the lung (SIR 3.5 vs. 2.6), bladder (SIR 3.2 vs. 4.0), pancreas (SIR 1.4 vs. 1.6), and colon (SIR 1.3 vs. 1.3). During ten years of follow-up, some 7% of males and 4% of females developed lung cancer. For bladder, colon and pancreas cancer, the cumulative hazards were 1% vs. 3.2%, 2.2% vs. 2.8%, and 0.7% vs. 0.9%, respectively. Conclusions: Patients suffering from symptomatic PAD face a markedly higher risk for incident cancer in the long-term follow-up. The cancer risk increased continuously for certain types and PAD was strongly associated with cancer of the lung, bladder, pancreas, and colon. Taking these results into account, PAD patients could benefit from secondary and tertiary screening. These results also emphasize the impact of common risk factors such as tobacco smoke as target for health prevention.
    Type of Medium: Online Resource
    ISSN: 0301-1526 , 1664-2872
    URL: Article
    DOI: 10.1024/0301-1526/a000901
    Language: English
    Publisher: Hogrefe Publishing Group
    Publication Date: 2020
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  • 3
    Online Resource
    Online Resource
    Periodontal treatment and peripheral arterial disease severity – a retrospective analysis of health insurance claims data
    Hogrefe Publishing Group ; 2020
    In:  Vasa Vol. 49, No. 2 ( 2020-03-01), p. 128-132
    Details
    In: Vasa, Hogrefe Publishing Group, Vol. 49, No. 2 ( 2020-03-01), p. 128-132
    Abstract: Summary: Background: Although epidemiological data suggest an association between periodontitis (PD) and peripheral arterial disease (PAD), it is currently unclear whether treatment of PD influences the severity of PAD. Patients and methods: Whether periodontal treatment is associated with PAD disease severity was examined by analysing health insurance claims data of patients insured by the German health insurance fund, BARMER, between January 1, 2012 and December 31, 2016. The presence of PAD was determined in individuals using International Classification of Diseases (ICD) 10 th revision codes for intermittent claudication (IC) or chronic limb threatening ischaemia (CLTI). Treatment of PD was assessed by adequate ambulatory coding for non-surgical and surgical treatment of PD. Multivariate logistic regression analysis was performed to evaluate the association between PAD stages and periodontal treatment, adjusted for diabetes, age and sex. Results: The study cohort included 70,944 hospitalized patients with a diagnosis of symptomatic PAD (54.99 % women, 49.05 % IC). Among these patients, 3,567 (5.03 %) had received prior treatment for PD by supra- or sub-gingival debridement. PAD patients who had received periodontal treatment showed a lower proportion of CLTI (28.76 % among treated vs. 52.12 % among non-treated). Using multivariable regression methods, exhibiting a CLTI (vs. IC) was associated with not being treated for PD (Odds Ratio 1.97, 95 %–CI 1.83–2.13) after adjustment for age, gender, and diabetes. Conclusions: In this large-scale retrospective analysis of health insurance claims data comprising hospitalized symptomatic PAD patients, treatment of PD was associated with PAD disease severity independent of age, gender and diabetes. A potential benefit of periodontal treatment in relation to PAD will have to be determined in further prospective studies.
    Type of Medium: Online Resource
    ISSN: 0301-1526 , 1664-2872
    URL: Article
    DOI: 10.1024/0301-1526/a000846
    Language: English
    Publisher: Hogrefe Publishing Group
    Publication Date: 2020
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  • 4
    Online Resource
    Online Resource
    Indicators of outcome quality in peripheral arterial disease revascularisations – a Delphi expert consensus
    Hogrefe Publishing Group ; 2018
    In:  Vasa Vol. 47, No. 6 ( 2018-10-01), p. 491-497
    Details
    In: Vasa, Hogrefe Publishing Group, Vol. 47, No. 6 ( 2018-10-01), p. 491-497
    Abstract: Abstract. 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.
    Type of Medium: Online Resource
    ISSN: 0301-1526 , 1664-2872
    URL: Article
    DOI: 10.1024/0301-1526/a000720
    Language: English
    Publisher: Hogrefe Publishing Group
    Publication Date: 2018
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