10-Year Results of the GREAT Registry: Lessons Learned From More Than 30 Publications

A decade of insights from the Global Registry for Endovascular Aortic Treatment (GREAT) was brought into focus in the opening session of Main Arena 2 this morning, spotlighting the prospective observational multicenter cohort registry that was initiated in November 2011.¹

Santi Trimarchi, MD, in collaboration with Chiara Lomazzi, MD, from the University of Milan, Italy, presented the aims of GREAT, relaying its contemporary real-world data on aortic endografts in the treatment of multiple aortic pathologies.

Drs Trimarchi and Lomazzi spoke to LINC Today to dive deeper into GREAT, offering a preview of some of the insights they shared today at LINC.

What prompted the creation of the GREAT Registry, and how would you sum it up to someone not familiar with its inception?

The GREAT Registry is a post-marketing registry launched by W.L. Gore 10 years ago, with the aim to better understand the follow-up of patients affected by aortic diseases, at any level, treated with Gore aortic endografts. Although this did not include imaging, several variables were utilized to check the results of these interventions. In particular, it was of interest to adopt a new consideration about the definition/importance of endoleaks, as these were defined as an issue that included both imaging evidence and clinical problems that necessitated additional hospital recovery.

What can you tell us about its design?

The GREAT Registry has enrolled up to 5,000 patients in about 110 centers across 4 different continents. It employs a multifaceted approach to data integration, combining clinical, demographic, and procedural information, with specific technical note and measures collected for planning (diameter, angle, extension, ancillary procedures on visceral vessels and sizing of device used) to create a holistic view of patient outcomes, thereby facilitating nuanced analyses that inform best practices in endovascular aortic treatment.

What were the early insights that set the scene in the last decade?

The GREAT Registry not only collects extensive clinical data but also plays a relevant role in identifying trends and patterns that can lead to improved treatment protocols and enhanced patient outcomes in real-life aortic disease management. The results, reported in several papers, observe a worldwide daily practice associated with the increasing experience of physicians when using these stent grafts, facing challenging anatomy—mostly out of instructions for use—in the setting of staged and emergent treatment.

But, above all, the registry focuses on assessing long-term patient outcomes which are vital for understanding the effectiveness of various endovascular treatments over time. By systematically gathering postoperative data, the GREAT Registry aims to provide insights into the durability of interventions (not only standard procedures) and inform future clinical practices for improved patient safety and care.

During follow-up, we noted that the number of patients decreased dramatically for mortality, primarily due to aging or patients no longer being able to go to the doctor for checkup. However, despite this, a consistent number of patients have been followed over 10 years.

The big question: Now at 10 years, with over 30 publications stemming from the registry, what are the key clinical insights or practice-changing findings that stand out to you?

With 5,000 patients managed with aortic endovascular procedures worldwide, GREAT has a consistent number to lend strength to analyses of specific topics, subgroups or less-conventional treatments. Examples we like to share include the initial experiences with feasibility of ascending thoracic endovascular aortic repair (TEVAR), different TEVAR results based on gender, different outcomes and follow-up in patients treated for thoracic aneurysms versus acute dissections, and the results of EVAR in patients with angulated or inverted conic proximal abdominal aortic necks.

Obviously, the manuscripts that reported these experiences went through the usual peer-review process, which not only improved the quality of individual studies, but also contributed to the overall advancement of knowledge in the field, encouraging innovative approaches and methodologies in research.

Overall, data from the registry has had constructive feedback. As is often the case, the publications have encouraged dialogue and critique from the research community, allowing for real-time feedback and adaptation of published work, thus keeping the scientific discourse dynamic and responsive to new findings, insights, collaborations and—last but not least—networking.

Have there been key challenges?

The GREAT Registry exemplifies the importance of collaborative research efforts in advancing medical knowledge, highlighting how shared data and insights can lead to improved clinical practices, enhanced patient outcomes, and a more robust understanding of vascular interventions.

The importance of Core Labs, and/or the availability of imaging to review specific issues or queries is one of the Achille’s heels of GREAT. In particular, a lesson learned for future registries is that imaging is definitely of primary importance.

What role do you see registries like GREAT playing in the future of research, and what is important to focus on next?

Registries have limits in terms of evidenc –that is clear. However, in the setting of aortic diseases, in particular those which need an emergent/urgent approach, registries can provide comprehensive databases that enable healthcare professionals to analyze treatment outcomes, identify effective interventions, and implement evidence-based practices. Their reflections on daily practice ultimately lead to enhanced patient care and safety in endovascular aortic treatments.

Finally, long-term results need to be investigated intently, as we treat with endovascular therapies more often in young patients, thus we need to include more information about stent graft durability and effects of interaction with aorta and body structures, like dynamics, hemodynamics, and changes in aortic stiffness.

Reference

1.    Loa J, Dubenec S, Cao P, et al. The Gore Global Registry for Endovascular Aortic Treatment: objectives and design. Ann Vasc Surg. 2016;31:70-76.