Inner branched complex aortic repair outcomes from a national multicenter registry using the E-xtra design platform

Simonte, Gioele; Isernia, Giacomo; Gatta, Emanuele; Neri, Eugénio; Parlani, Gianbattista; Candeloro, Laura; Schiavon, Sara; Pagliariccio, Gabriele; Cini, Marco; Lenti, Massimo; Carbonari, Luciano; Ricci, Carmelo

doi:10.1016/j.jvs.2022.08.034

Cited by 9 publications

(7 citation statements)

References 20 publications

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“…In our experience, the working space in the main body was sufficient for cannulation ( 11 ). In comparison, our fluoroscopy time and amount of contrast volume were quite similar to previous publications ( 13 , 14 ).…”

Section: Discussionsupporting

confidence: 91%

“…The fenestrations can be accessed through the femoral arteries, avoiding the need for an upper limb (brachial artery) access. But the sealing between the bridging stent and the main body relies only on the reinforced fenestration ring, comprising the risk for stent migration or fracture ( 14 , 23 , 24 ). In contrast, outer branches offer a stable overlap between the main body and the bridging stent.…”

Section: Discussionmentioning

confidence: 99%

“…In contrast, outer branches offer a stable overlap between the main body and the bridging stent. However, a wider aortic lumen is required ( 14 ). This was a relevant restriction, given the diameters seen in our cohort ( Table 2 ).…”

Section: Discussionmentioning

confidence: 99%

“…So far, the largest multicenter study from Italy by Simonte et al reports on 45 patients treated with a CMD inner-branch graft with reasonable technical success (93.3%), no in-hospital mortality, and 6.7% ( n = 3) persistent spinal cord ischemia. They publicized internal data provided by Artivion, that the request for inner branches increased up to 10-fold, and described inner branches as their preferred treatment device ( 14 ).…”

Section: Discussionmentioning

confidence: 99%

“…Recently, a pre-cannulated “off-the-shelf” endograft with four inner branches (E-nside; Artivion, Germany) has become available and enabling iBEVAR solution even for urgent and emergency cases ( 16 , 17 ). Up to now, only 84 cases of iBEVAR procedures ≥4 inner branches have been reported in three small cohort studies ( 11 , 13 , 14 ).…”

Section: Introductionmentioning

confidence: 99%

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Single-center initial experience with inner-branch complex EVAR in 44 patients

Kapalla

Busch

Lutz

et al. 2023

Front. Cardiovasc. Med.

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PurposeThe use of inner-branch aortic stent grafts in the treatment of complex aortic pathologies aims at broad applicability and stable bridging stent sealing compared to other endovascular technologies. The objective of this study was to evaluate the early outcomes with a single manufacturer custom-made and off-the-shelf inner-branched endograft in a mixed patient cohort.MethodsThis retrospective, monocentric study between 2019 and 2022 included 44 patients treated with inner-branched aortic stent grafts (iBEVAR) as custom-made device (CMD) or off-the-shelf device (E-nside) with at least four inner branches. The primary endpoints were technical and clinical success.ResultsOverall, 77% (n = 34) and 23% (n = 10) of the patients (mean age 77 ± 6.5 years, n = 36 male) were treated with a custom-made iBEVAR with at least four inner branches and an off-the-shelf graft, respectively. Treatment indications were thoracoabdominal pathologies in 52.2% (n = 23), complex abdominal aneurysms in 25% (n = 11), and type Ia endoleaks in 22.7% (n = 10). Preoperative spinal catheter placement was performed in 27% (n = 12) of patients. Implantation was entirely percutaneous in 75% (n = 33). Technical success was 100%. Target vessel success manifested at 99% (178/180). There was no in-hospital mortality. Permanent paraplegia developed in 6.8% (n = 3) of patients. The mean follow-up was 12 months (range 0–52 months). Three late deaths (6.8%) occurred, one related to an aortic graft infection. Kaplan–Meier estimated 1-year survival manifested at 95% and branch patency at 98% (177/180). Re-intervention was necessary for a total of six patients (13.6%).ConclusionsInner-branch aortic stent grafts provide a feasible option for the treatment of complex aortic pathologies, both elective (custom-made) and urgent (off-the-shelf). The technical success rate is high with acceptable short-term outcomes and moderate re-intervention rates comparable to existing platforms. Further follow-up will evaluate long-term outcomes.

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Section: Discussionsupporting

confidence: 91%