دورية أكاديمية
Diversion-p64: results from an international, prospective, multicenter, single-arm post-market study to assess the safety and effectiveness of the p64 flow modulation device
| العنوان: | Diversion-p64: results from an international, prospective, multicenter, single-arm post-market study to assess the safety and effectiveness of the p64 flow modulation device |
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| المؤلفون: | Bonafe, Alain, Perez, Marta, Aguilar, Henkes, Hans, Lylyk, Pedro, Bleise, Carlos, Gascou, Gregory, Sirakov, Stanimir, Sirakov, Alexander, Stockx, Luc, Turjman, Francis, Petrov, Andrey, Roth, Christian, Narata, Ana-Paula, Barreau, Xavier, Loehr, Christian, Berlis, Ansgar, Pierot, Laurent, Miś, Marcin, Goddard, Tony, Clifton, Andy, Klisch, Joachim, Wałęsa, Cezary, Dall’olio, Massimo, Spelle, Laurent, Clarencon, Frédéric, Yakovlev, Sergey, Keston, Peter, Nuzzi, Nunzio, Paolo, Dima, Stefanita, Wendl, Christina, Willems, Tine, Schramm, Peter |
| المساهمون: | Neuroradiologie Hôpital Gui de Chauliac, Hôpital Gui de Chauliac CHU Montpellier, Centre Hospitalier Régional Universitaire Montpellier (CHRU Montpellier)-Centre Hospitalier Régional Universitaire Montpellier (CHRU Montpellier), La Sagrada Familia Clinic/Clínica La Sagrada Familia Buenos Aires, Argentina (LSFC), St. Ivan Rilski University Hospital, Ziekenhuis Oost-Limburg (ZOL), Service de neuroradiologie Lyon, Hôpital neurologique et neurochirurgical Pierre Wertheimer CHU - HCL, Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL), Almazov National Medical Research Centre (St. Petersburg), CHU Trousseau Tours, Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Groupe hospitalier Pellegrin, Klinikum Vest GmbH, Klinikum Augsburg, Hôpital Maison Blanche, Hôpital universitaire Robert Debré Reims (CHU Reims), Wrocław Medical University, Leeds Teaching Hospitals NHS Trust, St George’s University Hospitals, Helios Klinikum Erfurt, Service de Neuroradiologie CHU de Bicêtre, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Faculté de Médecine Paris-Saclay, Hôpital Bicêtre AP-HP, Le Kremlin-Bicêtre, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris-Saclay, CHU Pitié-Salpêtrière AP-HP, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), NHS Lothian, Istituto Clinico Humanitas Milan (IRCCS Milan), Humanitas University Milan (Hunimed), University Hospital Regensburg |
| المصدر: | ISSN: 1759-8478. |
| بيانات النشر: | HAL CCSD BMJ Journals |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | aneurysm, flow diverter, stent, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, [SDV.MHEP.CHI]Life Sciences [q-bio]/Human health and pathology/Surgery |
| الوصف: | International audience ; Background: The use of flow diversion to treat intracranial aneurysms has increased in recent years.Objective: To assess the safety and angiographic efficacy of the p64 flow modulation device.Methods: Diversion-p64 is an international, prospective, multicenter, single-arm, study conducted at 26 centers. The p64 flow modulation device was used to treat anterior circulation aneurysms between December 2015 and January 2019. The primary safety endpoint was the incidence of major stroke or neurologic death at 3-6 months, with the primary efficacy endpoint being complete aneurysm occlusion (Raymond-Roy Occlusion Classification 1) on follow-up angiography.Results: A total of 420 patients met the eligibility criteria and underwent treatment with the p64 flow modulation device (mean age 55±12.0 years, 86.2% female). Mean aneurysm dome width was 6.99±5.28 mm and neck width 4.47±2.28 mm. Mean number of devices implanted per patient was 1.06±0.47, with adjunctive coiling performed in 14.0% of the cases. At the second angiographic follow-up (mean 375±73 days), available for 343 patients (81.7%), complete aneurysm occlusion was seen in 287 (83.7%) patients. Safety data were available for 413 patients (98.3%) at the first follow-up (mean 145±43 days) with a composite morbidity/mortality rate of 2.42% (n=10).Conclusions: Diversion-p64 is the largest prospective study using the p64 flow modulation device. The results of this study demonstrate that the device has a high efficacy and carries a low rate of mortality and permanent morbidity. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | info:eu-repo/semantics/altIdentifier/pmid/34782399; hal-03451439; https://hal.sorbonne-universite.fr/hal-03451439Test; https://hal.sorbonne-universite.fr/hal-03451439/documentTest; https://hal.sorbonne-universite.fr/hal-03451439/file/neurintsurg-2021-017809.full.pdfTest; PUBMED: 34782399 |
| DOI: | 10.1136/neurintsurg-2021-017809 |
| الإتاحة: | https://doi.org/10.1136/neurintsurg-2021-017809Test https://hal.sorbonne-universite.fr/hal-03451439Test https://hal.sorbonne-universite.fr/hal-03451439/documentTest https://hal.sorbonne-universite.fr/hal-03451439/file/neurintsurg-2021-017809.full.pdfTest |
| حقوق: | info:eu-repo/semantics/OpenAccess |
| رقم الانضمام: | edsbas.49B2E6D3 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1136/neurintsurg-2021-017809 |
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