Preliminary experience of Tubridge Plus flow diverter in the treatment of intracranial aneurysms
Objective The Tubridge Plus flow diverter (TPFD) is an iterative evolution of the previous Tubridge flow diverter (TFD) with enhanced technical features intended to overcome prior limitations. This single-center prospective study reported our preliminary experience using the TPFD for intracranial aneurysms (IAs), with evaluation of its technical feasibility, efficacy, safety, and outcomes. Methods Between May and July 2023, 10 consecutive patients with 10 IAs were enrolled and treated with TPFD in our institution. Technical success, intraoperative adverse events, angiographic outcomes were collected and analyzed. Results Technical success rate for TPFD delivery and deployment was 100%. Intraoperative adverse events, consisting of distal malapposition and iatrogenic proximal malapposition, occurred in 2 patients (20%), both successfully rescued with adjunctive stenting. No perioperative complications occurred, and only 1 patient (10%) experienced transient postoperative headache as a result of mass effect. Angiographic follow-up (FU) demonstrated that complete occlusion rates (OKM D at 6 months; RROC I at 1 year and last FU) improved progressively over time: 60% at 6 months, 80% at 1 year, and 90% at the last FU, with adequate occlusion rates of 90 and 100% at 1-year and the last FU, respectively. No in-stent stenosis or ipsilateral stroke was recorded in any patient during the entire FU period. Conclusion This prospective single-center preliminary experience in 10 patients suggests that TPFD is technically feasible, safe, and effective for the endovascular treatment of unruptured ICA aneurysms. However, given the small sample size and single-center design, further large-scale, multicenter studies with long-term FU are warranted to validate its safety and efficacy as a next-generation flow diverter.