New findings chronicling progress with both the Gore Excluder thoracoabdominal branch endoprosthesis (TAMBE)— approved by the Food and Drug Administration (FDA) last year—and Gore Tag thoracic branch endoprosthesis (TBE), which recently acquired a new indication for use in aortic zones 0 and 1, dotted the programs of some of the regional vascular society meetings in September.
Data gathered from the Mayo Clinic in Rochester, Minnesota, and the University of Southern California Keck Medical Center in Los Angeles for a comparative analysis between fenestrated and branched endovascular aneurysm repair (F/BEVAR) using physician-modified endografts (PMEGs) and the off-the-shelf TAMBE device for complex abdominal (AAAs) and thoracoabdominal aortic aneurysms (TAAAs) showed “comparable high technical success and optimal perioperative outcomes,” according to the study group.
Armin Tabiei, MD, a vascular surgery resident at the University of California Los Angeles (UCLA), presented findings from the study—covering procedures undertaken between 2015 and 2025— during the 2025 annual meeting of the Western Vascular Society (WVS) in Ojai, California (Sept. 14–17). Focused on a primary endpoint of freedom from target artery instability (TAI), Tabiei reported that among the 668 PMEG and 78 TAMBE patient groups, 77% of the former and 64% of the latter were estimated to be free of TAI at three years. “However, when only evaluating the renal target arteries, the freedom from instability was 89% for PMEG and 73% for TAMBE,” he said.
A majority of the patients were treated for TAAA, with a high rate of extent IV aneurysms. Early mortality occurred in 29 patients, all of whom were treated with a PMEG. Major adverse events occurred in 19% of the PMEG group and 17% of the TAMBE group.
Mean follow-up was 20 months in the PMEG group and 16 months in the TAMBE cohort. Three-year freedom from reintervention was 60% (PMEG) vs. 53% (TAMBE), while freedom from type I or III endoleak was 72% vs. 90%. “Freedom from aortic-related mortality was also similar, with rates of 99% in the TAMBE group and 94% in the PMEG group,” Tabiei added.
Overall survival was significantly lower in the PMEG group, with a three-year rate of 65% compared to 88% in the TAMBE group, which was “likely a reflection of more patients in the TAMBE group being treated under the clinical trial with more stringent inclusion criteria.”
Later in the same session, Zachary Rengel, MD, a vascular surgery resident from the Keck Medical Center, took a look at renal artery outcomes at the vessel level, comparing TAMBE and PMEG repairs, seeking to identify risk factors for TAI that could help guide patient selection. Covering procedures from 2015–2025 carried out at the same two aortic centers, Mayo and USC, Rengel told WVS that 633 patients underwent PMEG and 88 TAMBE. “This encompassed 1,339 renal arteries split almost evenly between the right and left,” he said.
At five years, freedom from TAI was significantly higher in PMEG patients at 89.5% compared to 82.7% in those treated with TAMBE. “Right renal arteries had worse performance with TAMBE—77.9% at two years compared to 91.3%,” Rengel continued. “Left renal arteries were comparable, with a significant difference seen between PMEG and TAMBE.”
In a subgroup analysis by aneurysm extent, “we saw that this difference in target vessel instability was driven by the pararenal aneurysms. Two-year freedom from target vessel instability was nearly 94% for PMEG but only 76% for TAMBE,” Rengel said. “In TAAAs, there was no significant difference: 93.5% for PMEG vs. 89.6% for TAMBE.”
Comparing bridging stent types in patients who had a single type, there was no significant difference in freedom from TAI between those used—VBX and iCast stents.
“We observed that primary patency in part drove the target vessel instability findings,” Rengel explained. “At five years, PMEG maintained to 94% patency versus 83% for TAMBE. Again, we saw that patients with pararenal aneurysms seemed to drive these findings with the two-year primary patency difference of almost 20%, although TAAAs saw a modest difference.
“When looking at laterality for primary patency, we saw again that the right renal artery had a more significant difference in comparison to the left, with five-year primary patency being 93% in PMEG and 80% in TAMBE. We did not observe any differences between PMEG and TAMBE in freedom from branch endoleaks, with TAMBE actually performing slightly better at 98.2% vs. 93.9%. Freedom from reintervention also favored PMEG at five years.”
Cox proportional hazard modeling showed that TAMBE usage and bridging stent diameter were independent risk factors of TAI, Rengel added. “These findings suggest that TAMBE renal branches have higher target vessel instability compared to PMEG, driven by the loss of primary patency and branch reintervention at the right renal artery, and is more pronounced in patients with pararenal aneurysms.”
At the 2025 Eastern Vascular Society (EVS) annual meeting in Nashville, Tennessee (Sept. 4–7), Amanda Rushing, MD, a vascular surgery resident at Mount Sinai in New York, reported on her institution’s experience with the TAMBE device.
Rushing and colleagues looked at eight patients enrolled in the TAMBE clinical trial from June 2021 to May 2024 and a further nine treated after device approval in June 2024. While the indication for all trial patients was aneurysmal and elective, the post-trial group included one emergent rupture and two type A aortic dissections with pararenal aneurysms, Rushing told EVS 2025. Among the post-trial patients, five would not have qualified for the clinical trial.
A higher percentage of post-trial patients had previous aortic coverage and a larger descending aorta compared to trial patients, she continued. “The post-trial patients had a longer length of stay and higher rates of transient spinal cord ischemia,” she said. “Both cohorts had no type I endoleaks, while one post-trial patient had a type III endoleak.”
There were no mortalities, strokes or myocardial infarctions (MIs) at 30 or 60 days among trial patients, whereas there was one MI within 30 days in the post-trial group, Rushing added.
“When looking at TAMBE in our postmarket analysis, patients treated outside the guidelines of the clinical trial had high technical success and comparable outcomes to those performed in the clinical trial,” she concluded.
Also at EVS 2025, Grayson Pitcher, MD, an assistant professor of vascular surgery at the University of Rochester in Rochester, New York, reported on lessons learned from a multi-institution case series of TAMBE cases involving wire wrapping of the celiac and superior mesenteric arteries. Wire wrapping most commonly occurs with celiac and superior mesenteric artery catheterization during interaction with the preloaded guidewires, Pitcher said, urging colleagues to be aware of this phenomenon.
“TAMBE has shown promising results, but something we have found is that stent wrapping can occur and it is important that everyone really be aware of this challenge,” Pitcher said, adding that the cases to which he referred highlighted the importance of using non-contrast cone-beam computed tomography.
TBE in zones 0 and 1
Meanwhile, new data emerged at EVS 2025 on the TBE, including patients receiving treatment in aortic zones 0 and 1, the expanded indication for which was approved by the FDA in June. Rushing, of Mount Sinai, delivered an institutional experience involving 32 TBE procedures between October 2022 and March 2025.
“TBE is the first off-the-shelf single-branch endoprosthesis for the zone 0, 1 and 2,” she told EVS. “Originally for zone 2 alone, this device has recent FDA approval for zone 0 and 1, and few studies have investigated the use of TBE in these zones, and even fewer its use in concomitant procedures, specifically type B aortic dissections [TBAD].”
The retrospective observational review included 25% with a zone 0 or zone 1 repair. Of the three patients who had a zone 0 repair, all involved chronic TBAD. Of five patients who had a zone 1 repair, three were aneurysmal in nature and two were chronic TBAD. Overall, a majority of the repairs (69%) were for TBAD, with the remaining 31% for aneurysm alone.
“For zone 0, all three of these patients underwent a right-carotid-to-left-subclavian bypass, and then transposing the left carotid onto that bypass,” Rushing explained. “In our remaining subset of zone 1 patients, three of the five underwent a left-carotid-to-left-subclavian transposition. This allowed us to cover the origin of the left common carotid artery with our portal into the left subclavian artery, and gaining that zone 1 access just distal to the innominate take off.
“We had a very high percentage of right-sided aortas in this patient population. Two of the 32 patients had right-sided arches,” Rushing continued. “One of these patients underwent a left-carotid-to-left-subclavian bypass with a TBE portal into the right subclavian artery. The other right-sided patient had a bilateral carotid-to-subclavian bypass with the TBE portal into the right common carotid artery. Among our other anatomic anomalies, one patient had aberrant right subclavian artery.”
Intraoperative and 30-day complications included three closure device failures, one patient had a common iliac rupture, two had unplanned partial coverage of a cerebral vessel, and one patient had a radial artery pseudoaneurysm, Rushing said.
Further, there were no patients with transient spinal cord ischemia, one patient had a type III endoleak and all stents were patent at 30-day follow-up. There was one stroke within 30 days and one mortality within 120 days resulting from respiratory failure and subsequent cardiac arrest.
“Of the patients that had follow-up within one to two years, there was no mortality, stroke or MI within this patient subset,” Rushing added.
