The p64 Flow Diverter—Mid-term and Long-term Results from a Single Center

Background and Purpose The p64 is a flow modulation device designed to be used in endovascular treatment of intracranial aneurysms. There is limited data on the long-term effectiveness of the device. This study sought to determine the safety and long-term efficacy of this device. Methods A retrospec...

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Veröffentlicht in:Clinical neuroradiology (Munich) 2020-09, Vol.30 (3), p.471-480
Hauptverfasser: Sirakov, S., Sirakov, A., Bhogal, P., Penkov, M., Minkin, K., Ninov, K., Hristov, H., Karakostov, V., Raychev, R.
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container_end_page 480
container_issue 3
container_start_page 471
container_title Clinical neuroradiology (Munich)
container_volume 30
creator Sirakov, S.
Sirakov, A.
Bhogal, P.
Penkov, M.
Minkin, K.
Ninov, K.
Hristov, H.
Karakostov, V.
Raychev, R.
description Background and Purpose The p64 is a flow modulation device designed to be used in endovascular treatment of intracranial aneurysms. There is limited data on the long-term effectiveness of the device. This study sought to determine the safety and long-term efficacy of this device. Methods A retrospective review of a prospectively maintained database was performed to identify all patients treated with a p64 between March 2015 and November 2018 at University Hospital St. Ivan Rilski. Anatomical features, intraprocedural complications, clinical, and angiographic outcomes were also taken into account and reviewed. Results A total of 72 patients with 72 aneurysms who met the inclusion criteria were identified. Device placement was successful in all patients. Follow-up angiographic imaging at 6 months showed complete occlusion (O’Kelly–Marotta scale [OKM] D) in 55 (76.3%) patients, subtotal aneurysmal filling (OKM B) in 10 (13.8%) patients, and neck remnant (OKM C) in 7 (9.7%) patients. Catheter angiography at 12 months was available for 70 patients (97.2%) and of these patients 91.4% of the aneurysms were completely occluded (OKM D) (64/72). Delayed angiography at 24 months was available for 68 patients (94.4%) and of these 98.5% (67/68) had completely occluded aneurysms. A 36-month angiography was available for 61 patients (84.4%) by which point all aneurysms had been completely occluded (100%). Permanent morbidity due to delayed aneurysmal rupture occurred in one patient (1.38%). The mortality rate was 0%. Self-limiting mild intimal hyperplasia was seen in 2 patients (2.72%). Conclusion Treatment of intracranial aneurysms with a p64 flow modulation device is safe and effective with a high success rate and only infrequent complications.
doi_str_mv 10.1007/s00062-019-00823-y
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There is limited data on the long-term effectiveness of the device. This study sought to determine the safety and long-term efficacy of this device. Methods A retrospective review of a prospectively maintained database was performed to identify all patients treated with a p64 between March 2015 and November 2018 at University Hospital St. Ivan Rilski. Anatomical features, intraprocedural complications, clinical, and angiographic outcomes were also taken into account and reviewed. Results A total of 72 patients with 72 aneurysms who met the inclusion criteria were identified. Device placement was successful in all patients. Follow-up angiographic imaging at 6 months showed complete occlusion (O’Kelly–Marotta scale [OKM] D) in 55 (76.3%) patients, subtotal aneurysmal filling (OKM B) in 10 (13.8%) patients, and neck remnant (OKM C) in 7 (9.7%) patients. Catheter angiography at 12 months was available for 70 patients (97.2%) and of these patients 91.4% of the aneurysms were completely occluded (OKM D) (64/72). Delayed angiography at 24 months was available for 68 patients (94.4%) and of these 98.5% (67/68) had completely occluded aneurysms. A 36-month angiography was available for 61 patients (84.4%) by which point all aneurysms had been completely occluded (100%). Permanent morbidity due to delayed aneurysmal rupture occurred in one patient (1.38%). The mortality rate was 0%. Self-limiting mild intimal hyperplasia was seen in 2 patients (2.72%). Conclusion Treatment of intracranial aneurysms with a p64 flow modulation device is safe and effective with a high success rate and only infrequent complications.</description><identifier>ISSN: 1869-1439</identifier><identifier>EISSN: 1869-1447</identifier><identifier>DOI: 10.1007/s00062-019-00823-y</identifier><identifier>PMID: 31399749</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer Berlin Heidelberg</publisher><subject>Aneurysms ; Care and treatment ; Hyperplasia ; Medical colleges ; Medical imaging ; Medicine ; Medicine &amp; Public Health ; Neurology ; Neuroradiology ; Neurosurgery ; Original Article</subject><ispartof>Clinical neuroradiology (Munich), 2020-09, Vol.30 (3), p.471-480</ispartof><rights>Springer-Verlag GmbH Germany, part of Springer Nature 2019</rights><rights>COPYRIGHT 2020 Springer</rights><rights>Springer-Verlag GmbH Germany, part of Springer Nature 2019.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c442t-46471acb637ff52b6f834ab4b681f1a31e072da119decbaf206b51163369c0b23</citedby><cites>FETCH-LOGICAL-c442t-46471acb637ff52b6f834ab4b681f1a31e072da119decbaf206b51163369c0b23</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00062-019-00823-y$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00062-019-00823-y$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,780,784,27924,27925,41488,42557,51319</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31399749$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Sirakov, S.</creatorcontrib><creatorcontrib>Sirakov, A.</creatorcontrib><creatorcontrib>Bhogal, P.</creatorcontrib><creatorcontrib>Penkov, M.</creatorcontrib><creatorcontrib>Minkin, K.</creatorcontrib><creatorcontrib>Ninov, K.</creatorcontrib><creatorcontrib>Hristov, H.</creatorcontrib><creatorcontrib>Karakostov, V.</creatorcontrib><creatorcontrib>Raychev, R.</creatorcontrib><title>The p64 Flow Diverter—Mid-term and Long-term Results from a Single Center</title><title>Clinical neuroradiology (Munich)</title><addtitle>Clin Neuroradiol</addtitle><addtitle>Clin Neuroradiol</addtitle><description>Background and Purpose The p64 is a flow modulation device designed to be used in endovascular treatment of intracranial aneurysms. There is limited data on the long-term effectiveness of the device. This study sought to determine the safety and long-term efficacy of this device. Methods A retrospective review of a prospectively maintained database was performed to identify all patients treated with a p64 between March 2015 and November 2018 at University Hospital St. Ivan Rilski. Anatomical features, intraprocedural complications, clinical, and angiographic outcomes were also taken into account and reviewed. Results A total of 72 patients with 72 aneurysms who met the inclusion criteria were identified. Device placement was successful in all patients. Follow-up angiographic imaging at 6 months showed complete occlusion (O’Kelly–Marotta scale [OKM] D) in 55 (76.3%) patients, subtotal aneurysmal filling (OKM B) in 10 (13.8%) patients, and neck remnant (OKM C) in 7 (9.7%) patients. Catheter angiography at 12 months was available for 70 patients (97.2%) and of these patients 91.4% of the aneurysms were completely occluded (OKM D) (64/72). Delayed angiography at 24 months was available for 68 patients (94.4%) and of these 98.5% (67/68) had completely occluded aneurysms. A 36-month angiography was available for 61 patients (84.4%) by which point all aneurysms had been completely occluded (100%). Permanent morbidity due to delayed aneurysmal rupture occurred in one patient (1.38%). The mortality rate was 0%. Self-limiting mild intimal hyperplasia was seen in 2 patients (2.72%). Conclusion Treatment of intracranial aneurysms with a p64 flow modulation device is safe and effective with a high success rate and only infrequent complications.</description><subject>Aneurysms</subject><subject>Care and treatment</subject><subject>Hyperplasia</subject><subject>Medical colleges</subject><subject>Medical imaging</subject><subject>Medicine</subject><subject>Medicine &amp; Public Health</subject><subject>Neurology</subject><subject>Neuroradiology</subject><subject>Neurosurgery</subject><subject>Original Article</subject><issn>1869-1439</issn><issn>1869-1447</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNp9kUFu1TAQhi0EolXbC7BAkdiwSfHYjh0vqwcFpIcqQVlbTjJ-pErsh51QvV0PwQE4C0fhJPiR0gqEkBee8Xz_r7F-Qp4APQVK1YtEKZWspKBLSmvGy90Dcgi11CUIoR7e1VwfkJOUrjJOea2rSj0mBxy41kroQ7K-_ITFVorifAjXxcv-C8YJ44-br-_6rszVWFjfFevgN0v3HtM8TKlwMeTR928fer8ZsFihz-Nj8sjZIeHJ7X1EPp6_uly9KdcXr9-uztZlKwSbSiGFAts2kivnKtZIV3NhG9HIGhxYDkgV6yyA7rBtrGNUNhWA5FzqljaMH5Hni-82hs8zpsmMfWpxGKzHMCfDmIKaK6h4Rp_9hV6FOfq83Z6irFaa1_fUxg5oeu_CFG27NzVn2YpJpSlk6vQfVD4djn0bPLo-v_8hYIugjSGliM5sYz_auDNAzT5Fs6RocormV4pml0VPbzeemxG7O8nvzDLAFyDlkd9gvP_Sf2x_AtEbpYo</recordid><startdate>20200901</startdate><enddate>20200901</enddate><creator>Sirakov, S.</creator><creator>Sirakov, A.</creator><creator>Bhogal, P.</creator><creator>Penkov, M.</creator><creator>Minkin, K.</creator><creator>Ninov, K.</creator><creator>Hristov, H.</creator><creator>Karakostov, V.</creator><creator>Raychev, R.</creator><general>Springer Berlin Heidelberg</general><general>Springer</general><general>Springer Nature B.V</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope></search><sort><creationdate>20200901</creationdate><title>The p64 Flow Diverter—Mid-term and Long-term Results from a Single Center</title><author>Sirakov, S. ; 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There is limited data on the long-term effectiveness of the device. This study sought to determine the safety and long-term efficacy of this device. Methods A retrospective review of a prospectively maintained database was performed to identify all patients treated with a p64 between March 2015 and November 2018 at University Hospital St. Ivan Rilski. Anatomical features, intraprocedural complications, clinical, and angiographic outcomes were also taken into account and reviewed. Results A total of 72 patients with 72 aneurysms who met the inclusion criteria were identified. Device placement was successful in all patients. Follow-up angiographic imaging at 6 months showed complete occlusion (O’Kelly–Marotta scale [OKM] D) in 55 (76.3%) patients, subtotal aneurysmal filling (OKM B) in 10 (13.8%) patients, and neck remnant (OKM C) in 7 (9.7%) patients. Catheter angiography at 12 months was available for 70 patients (97.2%) and of these patients 91.4% of the aneurysms were completely occluded (OKM D) (64/72). Delayed angiography at 24 months was available for 68 patients (94.4%) and of these 98.5% (67/68) had completely occluded aneurysms. A 36-month angiography was available for 61 patients (84.4%) by which point all aneurysms had been completely occluded (100%). Permanent morbidity due to delayed aneurysmal rupture occurred in one patient (1.38%). The mortality rate was 0%. Self-limiting mild intimal hyperplasia was seen in 2 patients (2.72%). Conclusion Treatment of intracranial aneurysms with a p64 flow modulation device is safe and effective with a high success rate and only infrequent complications.</abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><pmid>31399749</pmid><doi>10.1007/s00062-019-00823-y</doi><tpages>10</tpages></addata></record>
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subjects Aneurysms
Care and treatment
Hyperplasia
Medical colleges
Medical imaging
Medicine
Medicine & Public Health
Neurology
Neuroradiology
Neurosurgery
Original Article
title The p64 Flow Diverter—Mid-term and Long-term Results from a Single Center
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