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ORIGINAL ARTICLE   Free accessfree

Journal of Neurosurgical Sciences 2021 June;65(3):361-8

DOI: 10.23736/S0390-5616.21.05300-5


language: English

Long-term follow-up of the Derivo® Embolization Device (DED®) for intracranial aneurysms: the Italian Multicentric Registry

Mariangela PIANO 1, Emilio LOZUPONE 2 , Annalisa SGOIFO 1, Nunzio P. NUZZI 3, Francesco ASTEGGIANO 3, Guglielmo PERO 1, Luca QUILICI 1, Giuseppe IANNUCCI 4, Paolo CERINI 5, Chiara COMELLI 6, Simone PESCHILLO 7, Ciro PRINCIOTTA 8, Alessandro PEDICELLI 9, Nicola LIMBUCCI 10, Giuseppe GANCI 11, Guido TRASIMENI 12, Elisa CICERI 13, Giuseppe FARAGÒ 14, Andrea GIORGIANNI 15, Maurizio DE NICOLA 16, Paolo REMIDA 17, Elvis LAFE 18, Dikran MARDIGHIAN 19, Maria RUGGIERO 20, Guido A. LAZZAROTTI 21, Nicola CAVASIN 22, Lucio CASTELLAN 23, Luigi CHIUMARULO 24, Nicola BURDI 25, Aldo PAOLUCCI 26, Francesco BRIGANTI 27, Massimiliano NATRELLA 28, Francesco P. FLORIO 29, Marco PAVIA 30, Ivan GALLESIO 31, Giuseppe LUCENTE 32, Luigi GOZZOLI 33, Nevia CAPUTO 34, Simone VAGNARELLI 35, Edoardo BOCCARDI 1, Luca VALVASSORI 17, on behalf of the Italian DERIVO® Registry Group

1 ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy; 2 Vito Fazzi Hospital, Lecce, Italy; 3 IRCCS Humanitas Clinic, Rozzano, Milan, Italy; 4 ULSS 8 Berica, Vicenza, Italy; 5 Maggiore della Carità University Hospital, Novara, Italy; 6 San Giovanni Bosco Hospital, Turin, Italy; 7 Umberto I Polyclinic Hospital, Rome, Italy; 8 Bellaria Hospital, Bologna, Italy; 9 IRCCS A. Gemelli University Polyclinic Foundation, Rome, Italy; 10 Careggi University Hospital, Florence, Italy; 11 Santa Corona Hospital, Pietra Ligure, Savona, Italy; 12 Sant’Andrea Hospital, Rome, Italy; 13 Azienda Ospedaliera Universitaria Integrata di Verona (AOUI-Vr), Verona, Italy; 14 IRCCS Neurologic Institute C. Besta Foundation, Milan, Italy; 15 Circolo Hospital and Macchi Foundation, Varese, Italy; 16 Ospedali Riuniti University Hospital, Ancona, Italy; 17 ASST San Gerardo Hospital, Monza, Monza-Brianza, Italy; 18 IRCCS Polyclinic San Matteo Foundation, Pavia, Italy; 19 ASST Spedali Civili, Brescia, Italy; 20 M. Bufalini Hospital, Cesena, Forlì-Cesena, Italy; 21 Pisana University Hospital, Pisa, Italy; 22 Dell’Angelo Ulss 3 Hospital, Mestre, Venice, Italy; 23 San Martino Polyclinic, Genoa, Italy; 24 Polyclinic of Bari, Bari, Italy; 25 Santissima Annunziata Hospital, Taranto, Italy; 26 Ospedale Maggiore Policlinico, Milan, Italy; 27 Federico II University, Naples, Italy; 28 AUSL Valle d’Aosta, Aosta, Italy; 29 Casa Sollievo della Sofferenza Hospital, San Giovanni Rotondo, Foggia, Italy; 30 Poliambulanza Foundation, Brescia, Italy; 31 AON SS. Antonio e Biagio e Cesare Arrigo, Alessandria, Italy; 32 A. Perrino Hospital, Brindisi, Italy; 33 S. Croce e Carle Hospital, Cuneo, Italy; 34 Santa Maria Hospital, Terni, Italy; 35 San Giovanni Addolorata Hospital, Rome, Italy

BACKGROUND: The flow-diverter devices (FDDs) safety and effectiveness have been demonstrated by large series and meta-analyses. Due to the high occlusion rates and the acceptable morbidity rates of FDDs, the indications for their use are continuously expanding. We presented our Italian multicentric experience using the second generation of DERIVO® Embolization Device (DED®; Acandis, Pforzheim, Germany) to cure cerebral aneurysms, evaluating both middle and long-term safety and efficacy of this device.
METHODS: Between July 2016 and September 2017 we collected 109 consecutive aneurysms in 108 patients treated using DED® during 109 endovascular procedures in 34 Italian centers (100/109 aneurysms were unruptured, 9/109 were ruptured). The collected data included patient demographics, aneurysm location and characteristics, baseline angiography, adverse event and serious adverse event information, morbidity and mortality rates, and pre- and post-treatment modified Rankin Scale scores. Midterm and long-term clinical, angiographic and cross-sectional CT/MR follow-up were recorded and collected until December 2018.
RESULTS: In 2/109 cases, DED® placement was classified as technical failures. The overall mortality and morbidity rates were respectively 6.5% and 5.5%. Overall DERIVO® related mortality and morbidity rates were respectively 0% and 4.6% (5 out of 108 patients). Midterm neuroimaging follow-up showed the complete or nearly complete occlusion of the aneurysm in 90% cases, which became 93% at long-term follow-up. Aneurysmal sac shrinking was observed in 65% of assessable aneurysms.
CONCLUSIONS: Our multicentric experience using DED® for endovascular treatment of unruptured and ruptured aneurysms showed a high safety and efficacy profile, substantially equivalent or better compared to the other FDDs.

KEY WORDS: Intracranial aneurysm; Neurosurgery; Embolization, therapeutic

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