An international vascular registry infrastructure for medical device evaluation and surveillance

Sedrakyan, Art; Cronenwett, Jack L.; Venermo, Maarit; Kraiss, Larry W.; Marinac‐Dabic, Danica; Björck, Martin

doi:10.1016/j.jvs.2017.01.020

Cited by 15 publications

(12 citation statements)

References 9 publications

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“…Results were reported using the REporting of studies Conducted using Observational Routinely collected health Data (RECORD) statement, 27 the STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) statement, 28 and following international recommendations on medical device evaluation studies. 29 Cox regression models and visualisations were performed with software R version 3.3.3 (The R Foundation for Statistical Computing, Vienna, Austria). Illustrations were designed using Adobe Illustrator version 24.0.1 (Adobe Systems Software Ireland Ltd., Dublin, Republic of Ireland).…”

Section: Discussionmentioning

confidence: 99%

Long Term Outcomes After Revascularisations Below the Knee with Paclitaxel Coated Devices: A Propensity Score Matched Cohort Analysis

Heidemann

Peters

Kuchenbecker

et al. 2020

European Journal of Vascular and Endovascular Surgery

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WHAT THIS PAPER ADDS In this retrospective cohort study of 14 738 patients and 6 568 propensity score matched patients with index revascularisation below the knee between 1 January 2010 and 31 December 2018, a reduction was observed in long term all cause mortality and the combined endpoints of amputation or death and cardiovascular event or death five years after the use of paclitaxel coated devices when compared with uncoated devices for the treatment of chronic limb threatening ischaemia. The study addressed a key question in vascular medicine and using long term real world evidence does not confirm the potential harm reported in randomised controlled trials. Objective: Endovascular revascularisation has become a standard approach for below knee lesions and paclitaxel coated devices have been widely used in patients with chronic limb threatening ischaemia. A recent metaanalysis reported higher mortality in paclitaxel coated devices compared with uncoated devices in femoropopliteal lesions. This study aimed to determine long term outcomes in below the knee interventions using paclitaxel coated devices in routine vascular care using a large and contemporary cohort. Methods: A large cohort was created using all inclusive health insurance claims data of patients covered by the second largest insurance fund in Germany. The cohort included patients with index revascularisation of arteries below the knee performed from 1 January 2010, to 31 December 2018. Only patients with first paclitaxel coated device exposure were included. The study cohort was stratified into balloon vs. stent treatment and patients with paclitaxel coated devices were matched with uncoated devices using propensity score. Outcomes were evaluated using the KaplaneMeier method and Cox regression. Results: There were 14 738 patients (mean age 77.6 years, 43.6% female) and 6 568 matched patients included in the study. Increasing use of paclitaxel coated devices was observed during the study period (6% in 2010 vs. 31% in 2018, p < .001), and a total of 2 611 (39.8%) deaths occurred within five years of follow up. In the propensity score matched Cox model, a paclitaxel related reduction of five year mortality (hazards ratio, HR 0.84, 95% confidence interval, CI 0.78e0.91), amputation or death (HR 0.87, 95% CI 0.81e0.94), and cardiovascular event or death (HR 0.86, 95% CI 0.80e0.92) were observed. Conclusion: In this propensity score matched cohort, reduced long term all cause mortality, reduced rates of amputation or death and cardiovascular event or death were observed at five years after the use of paclitaxel coated devices when compared with uncoated devices for the treatment of chronic limb threatening ischaemia.

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Section: Discussionmentioning

confidence: 99%

Long Term Outcomes After Revascularisations Below the Knee with Paclitaxel Coated Devices: A Propensity Score Matched Cohort Analysis

Heidemann

Peters

Kuchenbecker

et al. 2020

European Journal of Vascular and Endovascular Surgery

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“…In 2014 Vascunet joined with the recently founded North American Society for Vascular Surgery Vascular Quality Initiative (VQI) and created the International Consortium of Vascular Registries. 246 Similar to the Vascunet, the focus of the VQI has been on PAD, but it has also reported on the proportion of patients treated for ALI. In a report on 15 338 bypass procedures and 33 926 endovascular procedures, 14% and 10%, respectively, were on patients admitted with ALI.…”

Section: Acute Limb Ischaemia In Existing Vascular Registriesmentioning

confidence: 99%

Editor's Choice – European Society for Vascular Surgery (ESVS) 2020 Clinical Practice Guidelines on the Management of Acute Limb Ischaemia

Björck

Earnshaw

Acosta

et al. 2020

European Journal of Vascular and Endovascular Surgery

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336

222

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“…Meanwhile, the international vascular medicine community has already recognized the complementary benefits of routinely collected data. Hence cooperation, such as the VASCUNET committee (www.vascunet.org) and the medical device epidemiology network (MDE-piNet; www.mdepinet.org) are already working intensively on methodological aspects and the enhanced harmonization of routinely collected data research [48]. In the current VASCUNET quality report on the interdisciplinary care of PAOD in 11 countries, for example, routinely collected data have been received for more than 1.1 million hospital cases.…”

Section: Discussionmentioning

confidence: 99%

Quality of care in surgical/interventional vascular medicine: what can routinely collected data from the insurance companies achieve?

et al. 2020

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The complexity and diversity of surgical/interventional vascular medicine necessitate innovative and pragmatic solutions for the valid measurement of the quality of care in the long term. The secondary utilization of routinely collected data from social insurance institutions has increasingly become the focus of interdisciplinary medicine over the years. Owing to their longitudinal linkage and pan-sector generation, routinely collected data make it possible to answer important questions and can complement quality development projects with primary registry data. Various guidelines exist for their usage, linkage, and reporting. Studies have shown good validity, especially for endpoints with major clinical relevance. The numerous advantages of routinely collected data face several challenges that require thorough plausibility and validity procedures and distinctive methodological expertise. This review presents a discussion of these advantages and challenges and provides recommendations for starting to use this increasingly important source of data.

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An international vascular registry infrastructure for medical device evaluation and surveillance

Cited by 15 publications

References 9 publications

Long Term Outcomes After Revascularisations Below the Knee with Paclitaxel Coated Devices: A Propensity Score Matched Cohort Analysis

Long Term Outcomes After Revascularisations Below the Knee with Paclitaxel Coated Devices: A Propensity Score Matched Cohort Analysis

Editor's Choice – European Society for Vascular Surgery (ESVS) 2020 Clinical Practice Guidelines on the Management of Acute Limb Ischaemia

Quality of care in surgical/interventional vascular medicine: what can routinely collected data from the insurance companies achieve?

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