Two projects evaluating AAA device performance will be included in IPAP, both of which aim to enroll consecutive patients for two years:
1. Infrarenal AAA Repair: For this study, both endovascular aortic repair (EVAR) and open repair will be evaluated. The focus of the study will be on device performance and comparative effectiveness between various EVAR devices and open AAA. For EVAR, aortic neck length >= 10 mm will be required, and for Open, a clamp below the renal arteries.
2. Juxtarenal Aortic Repair: Similar to the
infrarenal EVAR study, this study evaluates endovascular and open
repair of juxtarenal aortic aneurysms. All endovascular
techniques/devices including fenestrated EVAR, EVAS and parallel
stent techniques (i.e. chimney, snorkel, periscope stents) will be
evaluated in aneurysms that include the renals but not superior
mesenteric arteries. Neck length will be < 10 mm for EVAR and
for Open, a clamp above at least one renal artery.
The IPAP projects are being led by Adam Beck and Kevin Mani. Participating registries include VQI, Swedvasc, NORKAR, GermanVasc, HUSvasc, Hungarian Vascular Registry, Italian Vascular and Endovascular Registry, and Karbase.
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The main focus of the three retrospective InVASC projects is to compare treatment type (open vs. interventional) and patient selection (symptoms, urgency, patient demographics) between and within countries. The analyses will highlight differences in patient or procedure type selection that might lead to better understanding and reduced variation, and help identify future targets for outcome analysis. The three procedure types of interest are:
1. EVAR vs. Open AAA
Repair
2. Carotid Endarterectomy vs.
Stenting
3. Infrainguinal Bypass vs.
Intervention
Project
lead: Behrendt CA
(ESVS), Bertges D (VQI)
Aim of the project:
Get an overview on health care reality and practice in
peripheral arterial occlusive disesase (PAOD) treatment in
participating countries. Compare and harmonize table of data fields
and definitions. Find important questions that can be answered by
international registry projects (prospective data
collection).
Intermediate status (September 23,
2018):
The ICVR Consensus Recommendations for Peripheral Revascularization Registry Data Collection have been published in September 2018. A set of 79 items have been recommended. In order to allow different levels of detail to be collected by different registries, but still allow harmonisation, three "levels" of variable recording detail but with common core definitions were created. Thus, reporting levels were stratified for data elements as level 1, 2, and 3, ranging from minimum to optimum. Reporting level 1 for variables were considered the minimum information necessary and typically have a simple input (yes, no) or simple numeric range. Level 2 and 3 variables have additional increasing specificity and granularity.
In September 2018, a complementary Delphi consensus project was initiated by the European Society for Vascular Surgery (ESVS) and the ICVR. The goal of this additional project is to help defining reporting standards and variables suitable for quality improvement in medical care of patients suffering from acute limb ischaemia. (Questions: ch.behrendt@uke.de).
Simultaneously, registries within the ICVR are interviewed if they already of plan to comply to the ICVR consensus recommendations. (Questions: daniel.bertges@uvmhealth.org).
Link: ICVR minimal recommendations for PAD registries
Overall Questions: ch.behrendt@uke.de