ICCR

The International Consortium of Cardiovascular Registries (ICCR) is focused on two major initiatives:

  1. The International Consortium of Transcatheter Valve Registries (ICTVR) and
  2. The International Consortium of Vascular Registries (ICVR).

These two initiatives provide a collaborative platform through which registries and other stakeholders around the world can start a dialog, discuss data/methodology issues, and use aggregate level innovative analytic methods for conducting worldwide studies. An additional goal is to work with stakeholders such as manufacturers and regulators to improve their understanding of the safety and effectiveness of aortic valves and vascular devices designed to be implanted percutaneously. In order to promote this collaborative platform, the ICTVR and ICVR initiatives are creating one of the largest networks in the world, one that includes registries and academic centers with the research and clinical capability needed to tackle even the biggest obstacles related to cardiovascular device surveillance. Several papers are in preparation outlining the vision and research.

ICTVR

As surgical treatment options for valve disease are replaced by newer, less invasive procedures such as transcatheter valve replacement, questions about specific device performance, safety, and effectiveness remain unanswered in real-world settings. The implementation of International Consortium of Transcatheter Valve Registries (ICTVR) means development of an innovative framework for post-market surveillance of cardiovascular devices. This initiative establishes a collaborative global network among transcatheter valve registries to conduct analytic projects within the consortium. The governance model and research projects are innovative and we have built from the experience gained from ICOR. The registries participating in this network will identify gaps in evidence, harmonize relevant data and create innovative methodologies to analyze data in a distributed way. ICTVR has several aims:

  1. Develop a multi-national distributive transcatheter aortic valve replacement (TAVR) research network, including creating a governance structure whose leadership will oversee the creation of new methodological approaches for research and the establishment of public-private partnerships that will address stakeholder’s needs and sustainability.
  2. Align TAVR registry rare endpoints and other key variable definitions that support distributive research by reviewing current date fields in registries; then summarizing, defining, and prioritizing data elements in order to reach consensus on those definitions among registry leads around the world.

Conduct analytic ICTVR projects using distributive research methods through the description of the variation in international practice patterns, the evaluation of the association between specific patient and procedural characteristics, and rare procedure-related adverse outcomes, and determine the association between specific device attributes and in-hospital and mid-term outcomes.

Sedrakyan-200Art Sedrakyan, MD, PhD

 

 

Michael-MackMichael Mack, MD

 

 

Friedrich-Wilhelm MohrFriedrich-Wilhelm Mohr, MD, PhD

 

 

 

Kathleen-HewittKathleen Hewitt, MSN, RN, CPHQ

 

 

 

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 Maarit Venermo (Helsinki University) and the current US Chair is Adam Beck (University of Alabama at Birmingham); the past European Chair was Martin Bjorck (Uppsala University Hospital) and 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

Ongoing ICVR projects include:

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.