Call for Independent Research: Acute DeBakey Type I Aortic Dissection Treatments

Purpose

Gore is interested in supporting independent, investigator-initiated research conducted by qualified healthcare professionals involved in the diagnosis and treatment of patients with acute DeBakey Type I aortic dissections (Type A dissections with descending aortic involvement).

Research grant funding may be provided for proposals that seek to advance scientific and clinical understanding of disease management strategies and associated clinical and imaging outcomes following open and hybrid surgical approaches used in current practice. Surgical strategies evaluated should include hemiarch repair, extended or partial arch repair (e.g., Zone 2 arch reconstruction), and hybrid frozen elephant trunk (FET) approaches to management of acute DeBakey Type I aortic dissections.

Successful grant proposals are likely to have representation from multiple high-volume centers, each with extensive experience with the surgical approaches being studied.  The study should be sufficiently powered and designed to minimize selection bias (e.g., randomized) in order to best influence societal guidelines and clinical practice.  Preference will be given to proposals that have or will secure multiple sources of funding support (e.g., NIH, AHA).

Gore support for independent research is intended to foster objective scientific inquiry and to improve understanding of clinical decision-making in complex aortic disease. All funded research must be independently designed, conducted, analyzed, and reported by the investigator. Funding decisions are not related to, and are not conditioned upon, the use, purchase, or recommendation of any Gore products.

Research Needs

Despite advances in surgical and perioperative management, there remains ongoing clinical uncertainty regarding the optimal extent and sequencing of repair for many patients presenting with acute DeBakey Type I aortic dissection who are candidates for open surgery but do not have clear anatomic or clinical indications for routine inclusion of the aortic arch or descending thoracic aorta at the time of index repair [1–3].

Limited proximal repair strategies, such as ascending aorta replacement with or without hemiarch reconstruction, remain widely used and effectively address the most immediate life-threatening complications of acute Type A dissection. However, persistent dissection and false lumen patency in the residual arch and descending thoracic aorta are common and may be associated with late aneurysmal degeneration and the need for subsequent distal aortic intervention [2,4].

As a consequence, approximately 20–30% of patients undergoing limited proximal repair will require late distal aortic reintervention due to aneurysmal degeneration or progressive false lumen expansion [5–7]. This residual risk has led to increasing interest in more extensive arch reconstruction and hybrid or staged approaches aimed at improving distal aortic remodeling and reducing the need for subsequent reintervention [1,3,8].

One such strategy is the frozen elephant trunk (FET) procedure, which combines open replacement of the ascending aorta and entire aortic arch with simultaneous deployment of a stent graft into the proximal descending thoracic aorta. This approach promotes false lumen thrombosis and may facilitate future endovascular intervention if disease progression occurs. However, FET procedures increase operative complexity and have been associated with an increased risk of spinal cord ischemia, particularly with longer stent graft length and extensive distal coverage [9–12].

To balance the benefits of distal aortic disease management with the risks of extensive initial repair, some centers have adopted a staged hybrid strategy consisting of Zone 2 arch replacement with creation of a synthetic proximal landing zone for subsequent endovascular intervention when clinically indicated [13–16]. This approach allows selective distal intervention, avoids unnecessary stent graft coverage in patients who demonstrate favorable aortic remodeling after proximal repair, and may reduce the risk of spinal cord ischemia by staging coverage of the descending thoracic aorta.

Gore will not influence study design, data collection, analysis, interpretation, or publication of results. Investigators retain full control over their research and are responsible for ensuring that studies are conducted in accordance with applicable laws, regulations, institutional policies, and ethical standards.  Proposal budgets should include costs for open access fees where possible.

Activity Design

Please submit your concept proposal via our Portal or to the Grants Program Coordinator (Grants_Program@wlgore.com, +1 623-234-5521).

Outcomes Measurement

The objective of this request for research is to support independent studies that improve understanding of the clinical course, outcomes, and imaging-based aortic remodeling associated with different open surgical and hybrid or staged open-endovascular management strategies for acute DeBakey Type I aortic dissection.

Proposed research should capture pre-operative patient factors and evaluate perioperative outcomes, aortic growth or remodeling, planned and unplanned reintervention, neurologic outcomes, and other relevant clinical or imaging endpoints, as determined by the investigator. Studies should be designed to generate objective, generalizable evidence that may help inform future clinical decision-making, treatment algorithms, and societal guidelines for this complex patient population.

Terms and Conditions

We reserve the right to approve or deny any or all applications received as a result of this request or to cancel, in part or in its entirety, this request for grants.  Gore is not responsible for any costs associated with a grant application.