O-054 Prospective study on embolization of intracranial aneurysms with the pipeline device (PREMIER study): 3-year results with the application of a specific flow-diverter occlusion classification
Notice bibliographique
Résumé
Introduction Flow diverters proved to be a safe and efficacious approach for the management of large intracranial lesions. The PREMIER trial was the first prospective study to examine the efficacy of the pipeline embolization device (PED, Medtornic) for the management of small and medium size wide-necked aneurysms. Herein, we present the 3-year follow-up results from the PREMIER cohort. Methods The PREMIER was a prospective, single-arm study, including patients with a target wide-necked aneurysm of ≤ 12 mm, located in the internal carotid artery or vertebral artery. The primary effectiveness endpoint (complete aneurysm occlusion) and primary safety endpoint (major stroke in the supplied territory or neurologic death) were independently monitored and adjudicated. Additional angiographic evaluation to highlight the natural history of aneurysms treated with flow diverters was performed using the modified Cekirge-Saatci Classification (mCSC). Results According to CRL review, of 141 patients treated with PED, 25 (17.7%) required angiographic follow-up after the first year due to incomplete aneurysm occlusion. Three (12%) of these patients progressed to complete occlusion, resulting in a complete aneurysm occlusion rate at 3-year of 83.3% (115/138). Further angiographic evaluation using mCSC demonstrated that complete occlusion, neck residual, or aneurysm size reduction occurred in all cases with consecutive available follow-ups (97.1%). Overall safety endpoint occurred in 2.8% (4/140) of the patients over the 3-year follow-up, with only one event occurring after the first year – which was non-disabling at 2-year follow-up. Retreatment rate since initial device implantation was 5.0% (7/138): 4 within the first year and 3 within the second year, all carried on with PED in elective procedures. There was one case of aneurysm recurrence (0.7%) in a patient with an initially occluded aneurysm who afterward demonstrated residual neck at a 3-year follow-up. Not a single case of aneurysm rupture occurred in the series. Conclusions A high rate of aneurysm occlusion, low morbidity, and absence of aneurysm rupture emphasize the PED as a safe treatment strategy for small and medium-sized aneurysms located along the ICA and VA in the long term. Disclosures R. Hanel: 1; C; Unrestricted research grant from NIH, Interline Endowment, Microvention, Stryker, CNX. 2; C; Medtronic, Stryker, Cerenovous, Microvention, Balt, Phenox, Rapid Medical, and Q’Apel. He is on advisory board for MiVI, eLum, Three Rivers, Shape Medical and Corindus. 4; C; InNeuroCo, Cerebrotech, eLum, Endostream, Three Rivers Medical Inc, Scientia, RisT, BlinkTBI, and Corindus. G. Cortez: None. D. Lopes: 2; C; Asahi, Medtronic, and Stryker; honoraria from Siemens, Medtronic, Stryker, and Phenox. P. Nelson: 2; C; Medtronic, Phenox, and GmbH. A. Siddiqui: 2; C; Amnis Therapeutics, Boston Scientific, Canon Medical Systems USA, Cerebrotech Medical Systems, Claret Medical, Corindus, Endostream Medical, Guidepoint Global Consulting, Imperative Care, Integra, Rap. 4; C; in Amnis Therapeutics, Apama Medical, BlinkTBI, Buffalo Technology Partners, Cardinal Health, Cerebrotech Medical Systems, Claret Medical, Cognition Medical, Endostream Medical Ltd, Imperative Care, I. P. Jabbour: 2; C; Medtronic, Cerenovus, and Microvention. V. Pereira: 1; C; Philips. 2; C; Stryker, Penumbra, Balt, Medtronic, and Neurovasc. I. István: 2; C; Medtronic. O. Zaidat: 2; C; Medtronic, Stryker, Penumbra, and Cerenovus. C. Bettegowda: 2; C; Depuy-Synthes, Bionaut labs, and Galectin Therapeutics. G. Colby: 2; C; Medtronic, Microvention-Terumo, and Stryker. M. Mokin: 2; C; Cerebrotech, Imperative Care, and Penumbra; consulting fees form Medtronic, Cerenovus, and Canon Medical. C. Schirmer: 6; C; received honoraria from the American Association of Neurological Surgeons and Toshiba, and has ownership interest in NTI. F. Hellinger: None. C. Given II: 2; C; Medtronic and Stryker. 3; C; Medtronic and Stryker. T. Krings: 2; C; Stryker, Cerenovus, Penumbra, and Medtronic. P. Taussky: 2; C; Stryker Neurovascular, Cerenovus, and Medtronic. G. Toth: 2; C; Dynamed EBSCO and Microvention. J. Fraser: 2; C; Stream Biomedical, Penumbra, and Medtronic. 4; C; Fawkes Biotechnology, LLC, and Cerelux. M. Chen: 2; C; Medtronic, Stryker, Penumbra, Genentech, and GE. R. Priest: 2; C; Medtronic, Stryker, and Cerenovus. P. Kan: 2; C; Stryker Neurovascular, Medtronic, and Cerenovus. D. Fiorella: 1; C; Balt USA, Microvention, Penumbra, Siemens, and Stryker. 2; C; Arsenal Medical, Balt USA, Cerenovous, Marblehead, Medtronic, MENTICE-Vascular Simulations, Microvention, Neurogami, Qapel Medical, RAPID Medical, RAPID.AI, Stryker, Siemens. 6; C; honorarium from Qapel Medicine. D. Frei: 2; C; Penumbra, Stryker Neurovascular, Genentech, MicroVention, and Codman. B. Aagaard-Kienitz: None. O. Diaz: 6; C; proctor for Microvention/Terumo. A. Malek: 6; C; Cofounder, investor, and shareholder of CereVasc. C. Cawley: None. A. Puri: 1; C; Medtronic Neurovascular, Stryker Neurovascular, and Cerenovus. 2; C; Microvention, Agile, Merit, Corindus, QApel, Arsenal, and Imperative Care. D. Kallmes: 1; C; Medtronic, MicroVention, NeuroSave, Neurogami, Sequent Medical, NeuroSigma, and Insera. 6; C; President of Marblehead Medical and has patent pending in balloon catheter technologies.
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 | 0,002 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,002 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,001 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,002 | 0,000 |
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 ».