ICVR

Overview

The mission of the International Consortium of Vascular Registries (ICVR) is to provide a collaborative platform through which registries and other stakeholders around the world can share data to improve vascular health care. 

In order to create this collaborative platform, the ICVR is leveraging existing national registries, including the Society for Vascular Surgery Vascular Quality Initiative (VQI) and a history of collaboration in Vascunet, a "sub-committee of the European Society of Vascular Surgery which aims to increase knowledge and understanding of vascular disease, and to promote excellence in vascular surgery, by means of international vascular audit".

Currently two sets of projects are underway to investigate the safety and efficacy of vascular interventions: IPAP and InVASC.

 

Background

The International Consortium of Vascular Registries (ICVR) was launched in November 2014, in collaboration with the Society of Vascular Surgery (SVS)/Vascular Quality Initiative (VQI), the MDEpiNet Coordinating Center, and the European Society of Vascular Surgery VASCUNET registry to build an innovative international network dedicated to vascular surgery and device outcomes. The ICVR Leadership Board was established during the first meeting on November 17th, 2014. The second meeting of the ICVR Leadership Board was held on May 25-26, 2015, in Uppsala, Sweden, where the first prospective and retrospective projects of the collaboration were planned. The third meeting of the consortium was held on November 16th, 2015, in New York City, where these projects and analyses were discussed in greater detail.

 

The ICVR has direct data sharing from multiple national registries and distributed systems for research and surveillance, initially focusing on high priority questions related to the variation in device use and patient selection. The ICVR has access to data for hundreds of thousands of procedures performed to treat abdominal, carotid and lower limb arterial disease with both open and endovascular repairs. Since 2014, the representatives of 13 registries have developed a governance structure for data sharing and have held bi-annual meetings (alternating between US and Europe) to launch investigations.

Meeting of the International Consortium of Vascular Registries, Nov. 17th, 2014 

The international sharing of experience in quality improvement, desire to improve vascular care, and evaluation of device performance are three main motivators that have led to enthusiastic participation of national registries and clinician leaders. Importantly, most vascular devices are approved earlier in Europe than in the US, but the US population provides a larger cohort for device evaluation. Combining data from multiple registries accelerates the ability to detect device safety signals and benefits patients worldwide. The ICVR collaborative infrastructure will help adapt these methods to study vascular devices. The ICVR hosts forums for discussion including workshops and conferences. The ICVR members participate in scientific workshops and conferences intended to bring together external parties with relevant expertise to define evidence gaps and questions, datasets, and best practices.

Objectives

The major objective of the ICVR is to provide a collaborative platform through which registries and other stakeholders around the world can share data to improve vascular health care. The ICVR focuses on the development and testing of innovative methodological approaches. Examples include the use of directly linked (with de-identification) versus distributed network analyses, propensity scores, instrumental variables, inverse probability weighting, doubly robust estimation, registry-based randomized control trials, and other epidemiological methods which show great potential for use in medical device research. Other focuses of the ICVR include safety studies, surveillance, and comparative outcome evaluation. The ICVR research and surveillance studies aim to inform stakeholders about real-world outcomes of devices including advantages and disadvantages of different surgical techniques, devices and patient/pathology selection for treatment.

Additional details can be found below:

 1.       Development and testing of innovative methodological approaches

Registry science is a relatively new field with growing innovations in methodology.  Examples include the use of directly linked (with de-identification) versus distributed network analyses, propensity scores, instrumental variables, inverse probability weighting, doubly robust estimation, registry-based randomized control trials, and other epidemiological methods which show great potential for use in medical device research.  The ICVR collaborative infrastructure will help to adapt these methods to study vascular devices as appropriate.

2.       Forums for discussion: workshops, conferences

The ICVR members will participate in scientific workshops and conferences intended to bring together external parties with relevant expertise to define evidence gaps and questions, datasets, and best practices.

3.       Safety studies, surveillance and comparative outcome evaluation

ICVR research and surveillance studies aim to inform stakeholders about real world outcomes of devices including advantages and disadvantages of different surgical techniques, devices and patient/pathology selection for treatment.   In the regulatory science environment, ICVR members will develop plans for new registries, registry modifications or existing registry-based studies to inform clinical and regulatory decision making.

4.       Collaboration/peer reviewed articles and white papers

The ICVR members will collaborate as co-authors/peer reviewers on reports, manuscripts, white papers, and other communication conveying the results of work performed through the ICVR.

Partnership Structure

Member organizations of the ICVR include MDEpiNet, SVS-VQI, and Vascunet (HUSvasc, Swedvasc, UK National Vascular Registry, GermanVasc, NORKAR, Australasian Vascular Ft, Isvasc, Swissvasc, Hungarian Vascular Registry, Italian Vascular and Endovascular Registry, Karbase, Dutch Surgical Aneurysm Audit). A bulleted list of members is found below:

The ICVR Leadership Board was established during the first meeting on November 17, 2014. The current European Chair of the ICVR is Kevin Mani (Uppsala University) and the current US Chair is Adam Beck (University of Alabama at Birmingham); the past European Chairs were Martin Bjorck (Uppsala University Hospital) and Maarit Venermo (Helsinki University); the past US Chair was Jack Cronenwett (Dartmouth). In addition to the leadership board, the ICVR maintains advisors from the US FDA and input from stakeholder manufacturer representatives, such as Medtronic, Cook Medical, Gore, Endologix, and Terumo.

Existing Agreements

The ICVR maintains a memorandum of understanding with MDEpiNet Coordinating Center to advance the development of the CRN and collaborative learning communities. MDEpiNet also has agreement with the VQI and separate agreement with VASCUNET.

Patient Population

The ICVR maintains a registry database of roughly 226,135 patients, including 47,263 carotid endarterectomy (CEA) patients and 178,872 endovascular aneurysm repair (EVAR) patients.

Data Sources

In order to create this collaborative platform, the ICVR is leveraging existing national registries, including the SVS/VQI, and has a history of collaboration in VASCUNET, a sub-committee of the European Society of Vascular Surgery which aims to increase the knowledge and understanding of vascular disease and to promote excellence in vascular surgery by means of international vascular audits. Additionally, the ICVR contains registry data from Australia, Denmark, Finland, France, Hungary, Iceland, Malta, New Zealand, Sweden, Switzerland, Germany, Norway, and the US.

Past and Current Projects

International variation in device use: Projects have been completed for abdominal aortic aneurysms (AAA) devices and carotid devices. There are plans to also study new technologies and approaches, including an analysis of outcome variation of carotid endarterectomy based on carotid patch type and outcomes of peripheral intervention with the use of drug-eluting/coated devices (i.e. balloons and stents).

Volume outcomes study: The first phase of the current project evaluating volume-outcome relationship in AAA procedures has been completed. The second phase is specifically focused on the volume threshold for mortality after intact open AAA repair. Other ongoing projects include the analysis of the variation in outcome by country for intact AAA repair.

Ruptured abdominal aortic aneurysms (rAAA) study: A prospective study utilizing the registry network to evaluate EVAR device for ruptured abdominal aortic aneurysms (rAAA) is being planned. This study will enroll rAAA patients from participating registries undergoing EVAR comparing the short-term performance based on mortality to that of patients undergoing open treatment.

Global Harmonization of Registry Infrastructure: The ICVR’s current plans include continued global harmonization of registry infrastructure and the definition of items that will overcome limitations related to single country investigations and enhance the development of RWE. The ICVR completed the Delphi study for peripheral arterial revascularization which included 25 international vascular registry experts to achieve a consensus recommendation for a minimum core data set and an optimum data set for this patient population.

ICVR Prospective AAA Project (IPAP): 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.

InVASC PAOD Project:

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

Miscellaneous projects: Other tasks include updates to the implementation of the new European Union medical device regulation changes, registry quality improvement initiative, and the plan for High-performance Integrated Virtual Environment (HIVE) for data sharing to address EU General Data Protection Regulation requirements.

Publications

Co-chairs

Adam Beck, MD, FACS

Kevin Mani, MD

Coordinating Center

Art Sedrakyan, MD, PhD

Jialin Mao, MD, MS

Lead Contributors

Carlo Setacci

Christian-Alexander Behrendt, MD

Cristina Isaia

Danica Marinac-Dabic, MD, PhD

Daniel Bertges, MD

Fred Weaver

Gabor Menyhei

Grace Wang, MD

Jack Cronenwett, MD

Jennifer Brown

Jens Jorgensen, MD, FACS

Jim Wadzinski

Kristel Witteblos

Maarit Venermo

Marc Schermerhorn

Martin Altreuther

Matthew Thompson

Nicholas Osborne

Nicla Settembre

Nikolaj Eldrup