Michele Piazza, MD, informed attendees of the 2025 Vascular Annual Meeting (VAM) that increased experience with the E-nside (Artivion) off-the-shelf preloaded inner branch endograft for branched endovascular aneurysm repair (BEVAR) leads to a “significant” reduction in intraprocedural complications, but does not affect early mortality, major adverse event, or midterm results.
“The E-nside is an off-the-shelf preloaded inner-branched device for thoracoabdominal aortic aneurysm (TAAA) repair that was introduced in the European market in 2020,” Piazza, of the University of Padua in Italy, explained during the event in New Orleans (June 4–7). He noted that several cases have been performed with the device in the five-year period since then, with the objective of the present study being to report on the impact of the learning curve on the outcomes for the E-nside.
Piazza shared that he and colleagues used data from the multicenter, prospective Italian branch registry of E-nside endograft (INBREED) for the study, using data from 2021– 2024. The endpoints included technical success, mortality, intraprocedural adverse events, and major adverse events. The presenter noted that patients were divided into early and late cohorts based on the median date of the procedure in each center.
“Of a total of 215 cases, what was interesting was that, in the late phase, there was an increased selection of anatomical characteristics like those patients with chronic degenerative aneurysm or dissection, or degenerative aneurysm with a narrow paravisceral aorta less than 25mm,” Piazza commented, detailing patient characteristic insights.
Looking at the intraoperative technical results, Piazza reported that there was an increase in the use of femoral access with steerable sheaths over preloaded systems from the arm, an increase in the number of balloon-expandable bridging stents used, and a reduction in the number of adjunctive thoracic endografts deployed.
Piazza highlighted a reduction in the number of intraoperative complications that was statistically significant in the late cohort, but no difference in either technical success or major adverse event rates.
Stroke was reduced in the late cohort, Piazza continued; however, he specified that this was not statistically significant, and that there was no difference in the rate of freedom from target vessel instability at two years.
“Overall, the national trend showed a reduction in intraoperative complications,” Piazza commented, “but there were no differences between the early and the late phase for major adverse events.”
Highlighting results on the center-specific learning curve, Piazza noted that centers that faced more complex cases like extent II and III TAAAs or urgent cases “have an increase in the learning curve.” With regard to major adverse events, he underscored the fact that those centers with a low volume of cases had an increase in the learning curve over the first period which stabilized after the first five cases.
In conclusion, Piazza shared that experience with the E-nside led to a shift in patient selection, procedural techniques and materials. He continued that increased experience led to a significant reduction in intraprocedural complications, but stressed that this did not affect early mortality, major adverse event or midterm results.
During subsequent discussion time, an audience member asked Piazza if he could “dive a little bit deeper” into the learning curve comparing centers who had had a “robust experience,” perhaps with other platforms, versus those for which the E-nside was their “entry-level platform.”
Piazza responded that the study included two main different center experiences: those with an initial experience with BEVAR overall and those with a large experience with a different device before moving to the E-nside.
“In general,” he said, “what happens is that the second group is based on high-volume centers that all have experience in BEVAR, so this aspect by itself did not impact on the learning curve. What did have an impact on the learning curve was the number of cases performed with this device.”
