ICVR

Background

In November 2014, the MDEpiNet Coordinating Center, in collaboration with the SVS/VQI and the European Society of Vascular Surgery VASCUNET registry launched the ICVR to build an innovative international network dedicated to vascular surgery and device outcomes. 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.

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.

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).

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 MOU with MDEpiNet Coordinating Center to advance the development of the CRN and COP. MDEpiNet also has agreement with the VQI and sepaare agreement with VASCUNET.

Data Infrastructure

Patient population

The ICVR maintains a registry database of roughly 226,135 patients, including 47,263 CEA patients and 178,872 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.

Current Projects and Plans

International variation in device use: Projects have been completed for 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.

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.

More information about ICVR can be found here: http://www.icvr-initiative.org/

Contact: 

mdepinet@med.cornell.edu 

Coordinators

Adam Beck, MD, FACS

Kevin Mani

Contributors

Art Sedrakyan, MD, PhD

Carlo Setacci

Christian-Alexander Behrendt, MD

Cristina Isaia

Danica Marinac-Dabic, MD, PhD

Daniel Bertges, MD

Fred Weaver

Gabor Menyhei

Grace Wang

Jack Cronenwett, MD

Jennifer Brown

Jens Jorgensen, MD, FACS

Jialin Mao, MD, MS

Jim Wadzinski

Kristel Witteblos

Maarit Venermo

Marc Schermerhorn

Martin Altreuther

Matthew Thompson

Nicholas Osborne