TEVAR Device Indications Expanded for All Type B Aortic Dissections

EACTS @ STS: Management of Distal Type B Aortic Dissection

Tuesday

1:00 p.m. – 3:00 p.m.

Room 330AB

The US Food and Drug Administration recently expanded indications for two thoracic endovascular aortic repair (TEVAR) devices for the treatment of all classifications of type B aortic dissections, even though TEVAR’s efficacy had been studied only for type B acute complicated dissections. A session developed by STS and the European Association for Cardio-Thoracic Surgery (EACTS) will examine how this ruling has created a seismic shift in the distal treatment of thoracic aortic dissection.

“The FDA usually studies safety and efficacy before approval. In this particular case, it went with safety only and did not have data showing efficacy, which is usually the European model,” explained STS 2016-2017 President and session co-moderator Joseph E. Bavaria, MD. “This is a different strategy by the FDA. That is why this session was designed.”

Outcomes from TEVAR on patients with residual type A and other type B dissections will be collected to determine when it is the best treatment option.

“The FDA probably did the right thing. It is reasonable to have the community of cardiovascular surgeons see these patients and perform these procedures to develop the evidence one way or the other,” said
Dr. Bavaria, who is with the University of Pennsylvania School of Medicine in Philadelphia.

The use of the frozen elephant trunk has been adapted over time for more complex type A and B dissections, and Heinz Jakob, MD will share his insights about the progression of this device and its applications. With a device trial starting in the United States for use in acute type A dissections, this talk is apropos because surgeons have been using off-the-shelf devices, Dr. Bavaria said.

Dr. Jakob, of the University of Essen in Germany, is a pioneer in the use of the frozen elephant trunk in acute type A and B dissections to modify remodeling of the distal aorta, minimizing the development of late chronic type B dissections.

G. Chad Hughes, MD, of Duke University Medical Center in Durham, N.C., will address the merits of open thoracoabdominal aortic aneurysm surgery versus TEVAR for chronic type B dissections. Dr. Bavaria noted that Duke is one of a few centers performing both procedures.

“This lecture is important because we have significant equipoise in North America and Europe regarding the use of these procedures in the setting of chronic type B dissecting aneurysms,” Dr. Bavaria said. “There is no consensus about which is right to do. Dr. Hughes will talk about the nuances and decision making for each solution.”

Davide Pacini, MD, of the University of Bologna, Italy, will give his perspective on TEVAR versus medical management for acute uncomplicated type B dissections.

“There is no real robust data to tell us which acute uncomplicated dissections should be treated with TEVAR and which should not be,” Dr. Bavaria said. “Dr. Pacini will describe the features that would be favorable for good long-term results.”

Dr. Bavaria also added that for the first time, there will be a presentation on the newly designed thoracic aortic surgery section of the STS Adult Cardiac Surgery Database.

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