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Safety and efficacy of aneurysm treatment with WEB in the cumulative population of three prospective, multicenter series.

ABSTRACT: BACKGROUND:Flow disruption with the WEB is an innovative endovascular approach for treatment of wide-neck bifurcation aneurysms. Initial studies have shown a low complication rate with good efficacy. PURPOSE:To report clinical and anatomical results of the WEB treatment in the cumulative population of three Good Clinical Practice (GCP) studies: WEBCAST (WEB Clinical Assessment of Intrasaccular Aneurysm), French Observatory, and WEBCAST-2. METHODS:WEBCAST, French Observatory, and WEBCAST-2 are single-arm, prospective, multicenter, GCP studies dedicated to the evaluation of WEB treatment. Clinical data were independently evaluated. Postoperative and 1-year aneurysm occlusion was independently evaluated using the 3-grade scale: complete occlusion, neck remnant, and aneurysm remnant. RESULTS:The cumulative population comprised 168 patients with 169 aneurysms, including 112 female subjects (66.7%). The patients' ages ranged between 27 and 77 years (mean 55.5±10.2 years). Aneurysm locations were middle cerebral artery in 86/169 aneurysms (50.9%), anterior communicating artery in 36/169 (21.3%), basilar artery in 30/169 (17.8%), and internal carotid artery terminus in 17/169 (10.1%). The aneurysm was ruptured in 14/169 (8.3%). There was no mortality at 1?month and procedure/device-related morbidity was 1.2% (2/168). At 1?year, complete aneurysm occlusion was observed in 81/153 aneurysms (52.9%), neck remnant in 40/153 aneurysms (26.1%), and aneurysm remnant in 32/153 aneurysms (20.9%). Re-treatment was carried out in 6.9%. CONCLUSIONS:This series is at the moment the largest prospective, multicenter, GCP series of patients with aneurysms treated with WEB. It shows the high safety and good mid-term efficacy of this treatment. CLINICAL TRIAL REGISTRATION:French Observatory: Unique identifier (NCT18069); WEBCAST and WEBCAST-2: Unique identifier (NCT01778322).

SUBMITTER: Pierot L

PROVIDER: S-EPMC5969386 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

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Safety and efficacy of aneurysm treatment with WEB in the cumulative population of three prospective, multicenter series.

Pierot Laurent L Moret Jacques J Barreau Xavier X Szikora Istvan I Herbreteau Denis D Turjman Francis F Holtmannspötter Markus M Januel Anne-Christine AC Costalat Vincent V Fiehler Jens J Klisch Joachim J Gauvrit Jean-Yves JY Weber Werner W Desal Hubert H Velasco Stéphane S Liebig Thomas T Stockx Luc L Berkefeld Joachim J Molyneux Andrew A Byrne James J Spelle Laurent L

Journal of neurointerventional surgery 20170930 6

<h4>Background</h4>Flow disruption with the WEB is an innovative endovascular approach for treatment of wide-neck bifurcation aneurysms. Initial studies have shown a low complication rate with good efficacy.<h4>Purpose</h4>To report clinical and anatomical results of the WEB treatment in the cumulative population of three Good Clinical Practice (GCP) studies: WEBCAST (WEB Clinical Assessment of Intrasaccular Aneurysm), French Observatory, and WEBCAST-2.<h4>Methods</h4>WEBCAST, French Observatory ...[more]

PMID: 28965106

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Project description:BackgroundRadial access (RA) may offer advantages in peripheral interventions, but previous studies on this approach have been limited to retrospective or single-center studies. Our aim was to prospectively evaluate the safety and feasibility of RA for complex endovascular lower extremity interventions.MethodsIn this prospective, multicenter, and observational study, eligible patients with peripheral artery disease scheduled for intervention through RA were enrolled. Primary efficacy end point was procedural success, defined as successful completion of the intended procedure without conversion to femoral access and without RA complications periprocedure. Primary safety end point included evaluation of RA-related complications at 30 days.ResultsFrom June 2020 to June 2021, 120 patients at 8 US centers were enrolled. Mean age was 68.7 years, and 31.7% were women. The 224 lesions treated were in iliac (12.9%), femoropopliteal (55.3%), isolated popliteal (11.9%), and tibial (19.5%) vessels. The primary efficacy end point was achieved in 112 (93.3%) patients. One patient (<1%) required femoral access conversion to complete the procedure. Thirty (25.0%) patients required 1 or more additional access to facilitate crossing and/or to complete the planned treatment (5 femoral, 10 tibial, and 17 pedal accesses). No serious adverse events were adjudicated to the procedure. Mean procedure time and time to ambulation was 74 minutes and 3 hours 30 minutes; respectively, with 93.3% same-day discharge. At 30 days, 97.2% of patients recorded ultrasound-confirmed RA patency.ConclusionsThis is the first prospective and multicenter registry to show the safety and efficacy of RA approach for complex endovascular lesions and multilevel disease. RA allowed early ambulation and same-day discharge with no serious adverse events. Future randomized trials should examine the clinical and cost effectiveness of this approach compared with those of femoral access for patients with peripheral artery disease.

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Safety and efficacy of aneurysm treatment with WEB in the cumulative population of three prospective, multicenter series.

Publications

Safety and efficacy of aneurysm treatment with WEB in the cumulative population of three prospective, multicenter series.

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