LB-010 Safety and effectiveness assessment of the surpass evolve (SEASE): a real-world international multicenter study
Notice bibliographique
Résumé
Introduction/Purpose Flow diverters (FDs) are a well-established first-line treatment for specific intracranial aneurysms. The Surpass Evolve (SE) was introduced in 2019, and it is constructed with 48-64 wires (depending on the diameter) which enables navigation through an 0.027’ microcatheter. It has a high braid angle (rhomboid cell shape) that can be deployed through a significantly lower-profile delivery system. It maintains a high mesh density and uniform rhomboid cell shape regardless of its post-deployment state. Previously published studies on the SE are limited (case reports and series). Here we report the first international multi-center study evaluating the safety and effectiveness of the SE. Materials and Methods We performed an international, multicenter, cross-sectional, single-arm cohort study at 16 large-volume centers. All patients treated with the SE for intracranial aneurysms between 2020-2021 were included. Demographic, clinical, angiographic, and follow-up data were collected. Primary effectiveness outcome was complete occlusion (Raymond-Roy Class 1) at 1-year follow-up. Safety outcomes included the incidence of ischemic/hemorrhagic at 30 days and mortality. All radiographical outcomes were evaluated by independent core lab adjudication. Results 299 patients with 333 aneurysms underwent treatment with SE. Median age was 59 [50-67] years, and 252 (84%) were female. Most patients were white (187, 62%). Hypertension was the most common comorbidity in 150 (50%), and 115 (39%) patients were smokers. The baseline modified Rankin scale (mRS) was 0-2 in 290 (93%) of the cases, and the majority were unruptured (279, 93%) and saccular (269, 90%). Previous treatment was present in 76 (25%) patients, primarily with coils (54, 18%). Median aneurysm size was 5.5 [3.5-9] mm, and median neck width was 3.4 [2.6-4.8] mm. Most aneurysms were located in the paraophthalmic segment of the internal carotid artery (127, 43%), followed by the supraclinoid (93; 31%), and petrocavernous segments (39, 13%). Mean number of SEs implanted per patient was 1.00 (range 1-3). Radial access was used in 59 (20%) cases. Adjunctive coils in 29 (10%) and balloon-assisted angioplasty in 118 (40%) cases. At 10.8 [6.5-14.1] months median follow-up, 183/259 (71%) cases achieved complete aneurysm occlusion. Ischemic events were reported in 7 (3%) cases, hemorrhagic events in 1 (0.4%), and 4 (1%) deaths. Conclusion SEASE is the largest international multicenter study reporting outcomes after the implantation of the SE. Our results demonstrate that a 64-wire FD such as the SE has reliable effectiveness and carries a low rate of safety events in the treatment of mainly medium-sized aneurysms. Disclosures J. Vivanco-Suarez: None. J. Fifi: None. D. Lopes: None. A. Rodriguez-Calienes: None. A. Devarajan: None. G. Toth: None. T. Patterson: None. D. Altschul: None. G. Cortez: None. R. Hanel: None. E. Liu: None. V. Pereira: None. A. Kühn: None. A. Puri: None. W. Guerrero: None. I. Bach: None. P. Khandelwal: None. S. Satti: None. G. Edhayan: None. P. Kan: None. M. Martinez-Galdamez: None. C. Given: None. B. Gross: None. Y. Lu: None. M. Galecio-Castillo: None. C. Alva: None. M. Farooqui: None. S. Drakhshani: None. S. Ortega-Gutierrez: None.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,003 | 0,003 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,000 |
| Méta-épidémiologie (sens large) | 0,000 | 0,001 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,001 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,000 | 0,001 |
| Intégrité de la recherche | 0,000 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,002 | 0,001 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».