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Following the European launch of the recently CE-marked GORE TAG Thoracic Branch Endoprosthesis (TBE) device, Joseph Bavaria (University of Pennsylvania, Philadelphia, USA) gives Vascular News an insight into the wide-ranging impact this single-branch arch graft is likely to have across the thoraco-aortic surgery space.
“This device has very radically changed the way I think about thoraco-aortic surgery— both from an open standpoint as well as an endovascular standpoint,” Bavaria says, providing a message to his peers in Europe. “In every decision that we make regarding thoraco-aortic surgery today, we always think, ‘where does the TBE fit into this treatment plan? Are we going to be able to use a TBE in this particular case and, if we are, how are we going to do it?’
“The availability of the TBE has changed the entire way we think about thoraco-aortic surgery, and it comes into play in our decision-making processes regarding how we’re going to treat a particular patient. So, it’s very welcome, and it’s an incredibly good graft.”
A shift in practice
“I believe that [the TBE] is the most important device for the thoracic aorta since the invention of the regular, original TEVAR [thoracic endovascular aortic repair] device,” Bavaria goes on. “This is going to be a very important, even revolutionary development in TEVAR and thoracic aortic disease treatment. The single-branch arch graft allows for and will be responsible for a whole bunch of changes in the way we treat patients with thoracic aortic disease—and that includes dissections and aneurysms, as well as traumatic transections.”
Bavaria forecasts a shift in thoraco-aortic surgery practices based on the availability of this device, noting that operators will perform open arch procedures in zone 2 with a view to “setting these cases up” for subsequent distal TEVAR. This is because zone 2 arch operations are “much easier”, and can be performed by a greater number of surgeons— in addition to reducing morbidity and mortality—as compared to, for example, elephant trunk or zone 3 ‘classic arch’ procedures.
“What this means is, in type A dissections, or arch aneurysms, or chronic, residual dissections, for example, the cardiac surgeon can perform a zone 2 arch—either in a redo setting or not. That is an operation that is relatively straightforward compared to a total arch,” Bavaria continues. “And, then, the TEVAR solution utilising the TBE can be performed with relative ease. That is very, very important, because cardiac surgeons who do arch surgery will change the way they treat cases, and change the operations they do, based on the availability of these new grafts.”
Another prediction Bavaria makes is that carotid-subclavian bypass operations will become something of a “historical footnote” following the advent of single-branch arch TEVAR, which is a “very welcome development” and one that is likely to represent good news for patients as well. Bavaria goes on to state that the TBE device also offers a “very robust” solution for both chronic and acute type B aortic dissections— and anticipates the graft being used in up to half of all type B dissections moving forward.
Yet another new frontier Bavaria sees being explored with the TBE is in traumatic transection. He notes that many of these cases require partial or complete coverage of the left subclavian artery, in order to provide a “reasonable landing zone”, but that the TBE removes this consideration entirely; as Bavaria states, “you just put in the graft and you will have a perfect situation, and you don’t need to worry about coverage of the subclavian artery”.
Bavaria believes that, overall, the TBE device is likely to create new possibilities and provide benefits for a wide range of patients across multiple domains of thoraco-aortic surgery, and lists no fewer than five distinct yet significant case types that constitute ideal candidates for treatment with the graft in zone 2: acute type A dissections needing sequential TEVAR; chronic residual type A dissections with zone 2 arch procedures; acute type B dissections; chronic type B dissections; and acute traumatic transections. He also posits that there are relatively few contraindications for the use of the device in these populations, with an insufficient landing zone in zone 2 and a dissected left subclavian artery being the most common considerations here.
“The bottom line is that the single-branch arch graft—the TBE—will revolutionise the way we think about how to treat a series of thoraco-aortic conditions,” Bavaria adds. “This is a gigantic change, and I think it will be very important in our armamentarium to have these devices and to be able to do these procedures.”
Device characteristics
Homing in on specific characteristics of the device that make it such a successful tool across a myriad of thoraco-aortic surgical frontiers, Bavaria first highlights that he and his colleagues have been “very pleased” with the durability of the device. He notes that his centre began implanting patients with the TBE in clinical studies back in late 2014, with its durability therefore being observed out to almost 10 years, and provides similarly positive feedback on the patency and durability being seen in the branched part of the arch.
“The conformability of the device is good,” Bavaria says, alluding to another of the TBE’s key characteristics. “It’s not perfect because, sometimes—in a very angulated arch—it does not yet have the same Active Control delivery system as the Gore CTAG device. But, it’s very good, and I’ve personally had minimal issues with conformability at zone 2.”
Bavaria further notes that, in his experience, procedures utilising the graft have produced minimal paraplegia rates (0.4% through one month), and paraplegia associated with the device itself is ultimately “not a major issue”. And, even more importantly, he adds, studies of the device have found notably low stroke rates—stroke rates that were much lower than Bavaria and his colleagues had initially anticipated, and were especially low in dissection subgroups (0.8% stroke rate for dissection cohort through 12 months).
“For branched arch grafts, the Achilles’ heel, and the biggest problem in history, is stroke. Stroke is what’s holding back the entire development and clinical trials of arch-branch grafting, so mitigating or decreasing stroke is the single most important thing regarding approval of these devices across the whole world,” Bavaria asserts. “We’re very pleased with the low stroke rates in the TBE zone 2 FDA [Food and Drug Administration] submission compared to the stroke rates in any other trial for a branched arch graft. That was the big surprise—the pleasant surprise—that the disabling stroke rates were pretty low, 2.9% for all cohorts through 12 months.”
