Early Postmarket Results After Treatment of Intracranial Aneurysms With the Pipeline Embolization Device: A US Multicenter Experience
The pipeline embolization device (PED) is the latest technology available for intracranial aneurysm treatment. To report early postmarket results with the PED. This study was a prospective registry of patients treated with PEDs at 7 American neurosurgical centers subsequent to Food and Drug Administ...
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| Veröffentlicht in: | Neurosurgery 2012-12, Vol.71 (6), p.1080-1087 |
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| creator | KAN, Peter SIDDIQUI, Adnan H RINGER, Andrew J WELCH, Babu G HOROWITZ, Michael B SNYDER, Kenneth V NELSON HOPKINS, L LEVY, Elad I VEZNEDAROGLU, Erol LIEBMAN, Kenneth M BINNING, Mandy J DUMONT, Travis M OGILVY, Christopher S GAUGHEN, John R MOCCO, J VELAT, Gregory J |
| description | The pipeline embolization device (PED) is the latest technology available for intracranial aneurysm treatment.
To report early postmarket results with the PED.
This study was a prospective registry of patients treated with PEDs at 7 American neurosurgical centers subsequent to Food and Drug Administration approval of this device. Data collected included clinical presentation, aneurysm characteristics, treatment details, and periprocedural events. Follow-up data included degree of aneurysm occlusion and delayed (> 30 days after the procedure) complications.
Sixty-two PED procedures were performed to treat 58 aneurysms in 56 patients. Thirty-seven of the aneurysms (64%) treated were located from the cavernous to the superior hypophyseal artery segment of the internal carotid artery; 22% were distal to that segment, and 14% were in the vertebrobasilar system. A total of 123 PEDs were deployed with an average of 2 implanted per aneurysm treated. Six devices were incompletely deployed; in these cases, rescue balloon angioplasty was required. Six periprocedural (during the procedure/within 30 days after the procedure) thromboembolic events occurred, of which 5 were in patients with vertebrobasilar aneurysms. There were 4 fatal postprocedural hemorrhages (from 2 giant basilar trunk and 2 large ophthalmic artery aneurysms). The major complication rate (permanent disability/death resulting from perioperative/delayed complication) was 8.5%. Among 19 patients with 3-month follow-up angiography, 68% (13 patients) had complete aneurysm occlusion. Two patients presented with delayed flow-limiting in-stent stenosis that was successfully treated with angioplasty.
Unlike conventional coil embolization, aneurysm occlusion with PED is not immediate. Early complications include both thromboembolic and hemorrhagic events and appear to be significantly more frequent in association with treatment of vertebrobasilar aneurysms. |
| doi_str_mv | 10.1227/NEU.0b013e31827060d9 |
| format | Article |
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To report early postmarket results with the PED.
This study was a prospective registry of patients treated with PEDs at 7 American neurosurgical centers subsequent to Food and Drug Administration approval of this device. Data collected included clinical presentation, aneurysm characteristics, treatment details, and periprocedural events. Follow-up data included degree of aneurysm occlusion and delayed (> 30 days after the procedure) complications.
Sixty-two PED procedures were performed to treat 58 aneurysms in 56 patients. Thirty-seven of the aneurysms (64%) treated were located from the cavernous to the superior hypophyseal artery segment of the internal carotid artery; 22% were distal to that segment, and 14% were in the vertebrobasilar system. A total of 123 PEDs were deployed with an average of 2 implanted per aneurysm treated. Six devices were incompletely deployed; in these cases, rescue balloon angioplasty was required. Six periprocedural (during the procedure/within 30 days after the procedure) thromboembolic events occurred, of which 5 were in patients with vertebrobasilar aneurysms. There were 4 fatal postprocedural hemorrhages (from 2 giant basilar trunk and 2 large ophthalmic artery aneurysms). The major complication rate (permanent disability/death resulting from perioperative/delayed complication) was 8.5%. Among 19 patients with 3-month follow-up angiography, 68% (13 patients) had complete aneurysm occlusion. Two patients presented with delayed flow-limiting in-stent stenosis that was successfully treated with angioplasty.
Unlike conventional coil embolization, aneurysm occlusion with PED is not immediate. Early complications include both thromboembolic and hemorrhagic events and appear to be significantly more frequent in association with treatment of vertebrobasilar aneurysms.</description><identifier>ISSN: 0148-396X</identifier><identifier>EISSN: 1524-4040</identifier><identifier>DOI: 10.1227/NEU.0b013e31827060d9</identifier><identifier>PMID: 22948199</identifier><identifier>CODEN: NRSRDY</identifier><language>eng</language><publisher>Hagerstown, MD: Lippincott Williams & Wilkins</publisher><subject>Aged ; Aneurysms ; Angioplasty ; Aspirin - therapeutic use ; Biological and medical sciences ; Blood Vessel Prosthesis ; Embolization ; Embolization, Therapeutic - instrumentation ; Embolization, Therapeutic - methods ; Female ; Fibrinolytic Agents - therapeutic use ; Follow-Up Studies ; Humans ; Intracranial Aneurysm - therapy ; Male ; Medical sciences ; Middle Aged ; Neurosurgery ; Postoperative Complications ; Product Surveillance, Postmarketing ; Retrospective Studies ; Stents ; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases ; Thromboembolism ; Treatment Outcome ; United States</subject><ispartof>Neurosurgery, 2012-12, Vol.71 (6), p.1080-1087</ispartof><rights>2014 INIST-CNRS</rights><rights>2008 by the Congress of Neurological Surgeons</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c314t-400eecfb22e663378970d9c7fd997aeaf461fdd1f24248d615cea4f87b9526c93</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>315,781,785,27929,27930</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=26701692$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22948199$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>KAN, Peter</creatorcontrib><creatorcontrib>SIDDIQUI, Adnan H</creatorcontrib><creatorcontrib>RINGER, Andrew J</creatorcontrib><creatorcontrib>WELCH, Babu G</creatorcontrib><creatorcontrib>HOROWITZ, Michael B</creatorcontrib><creatorcontrib>SNYDER, Kenneth V</creatorcontrib><creatorcontrib>NELSON HOPKINS, L</creatorcontrib><creatorcontrib>LEVY, Elad I</creatorcontrib><creatorcontrib>VEZNEDAROGLU, Erol</creatorcontrib><creatorcontrib>LIEBMAN, Kenneth M</creatorcontrib><creatorcontrib>BINNING, Mandy J</creatorcontrib><creatorcontrib>DUMONT, Travis M</creatorcontrib><creatorcontrib>OGILVY, Christopher S</creatorcontrib><creatorcontrib>GAUGHEN, John R</creatorcontrib><creatorcontrib>MOCCO, J</creatorcontrib><creatorcontrib>VELAT, Gregory J</creatorcontrib><title>Early Postmarket Results After Treatment of Intracranial Aneurysms With the Pipeline Embolization Device: A US Multicenter Experience</title><title>Neurosurgery</title><addtitle>Neurosurgery</addtitle><description>The pipeline embolization device (PED) is the latest technology available for intracranial aneurysm treatment.
To report early postmarket results with the PED.
This study was a prospective registry of patients treated with PEDs at 7 American neurosurgical centers subsequent to Food and Drug Administration approval of this device. Data collected included clinical presentation, aneurysm characteristics, treatment details, and periprocedural events. Follow-up data included degree of aneurysm occlusion and delayed (> 30 days after the procedure) complications.
Sixty-two PED procedures were performed to treat 58 aneurysms in 56 patients. Thirty-seven of the aneurysms (64%) treated were located from the cavernous to the superior hypophyseal artery segment of the internal carotid artery; 22% were distal to that segment, and 14% were in the vertebrobasilar system. A total of 123 PEDs were deployed with an average of 2 implanted per aneurysm treated. Six devices were incompletely deployed; in these cases, rescue balloon angioplasty was required. Six periprocedural (during the procedure/within 30 days after the procedure) thromboembolic events occurred, of which 5 were in patients with vertebrobasilar aneurysms. There were 4 fatal postprocedural hemorrhages (from 2 giant basilar trunk and 2 large ophthalmic artery aneurysms). The major complication rate (permanent disability/death resulting from perioperative/delayed complication) was 8.5%. Among 19 patients with 3-month follow-up angiography, 68% (13 patients) had complete aneurysm occlusion. Two patients presented with delayed flow-limiting in-stent stenosis that was successfully treated with angioplasty.
Unlike conventional coil embolization, aneurysm occlusion with PED is not immediate. Early complications include both thromboembolic and hemorrhagic events and appear to be significantly more frequent in association with treatment of vertebrobasilar aneurysms.</description><subject>Aged</subject><subject>Aneurysms</subject><subject>Angioplasty</subject><subject>Aspirin - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Blood Vessel Prosthesis</subject><subject>Embolization</subject><subject>Embolization, Therapeutic - instrumentation</subject><subject>Embolization, Therapeutic - methods</subject><subject>Female</subject><subject>Fibrinolytic Agents - therapeutic use</subject><subject>Follow-Up Studies</subject><subject>Humans</subject><subject>Intracranial Aneurysm - therapy</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Neurosurgery</subject><subject>Postoperative Complications</subject><subject>Product Surveillance, Postmarketing</subject><subject>Retrospective Studies</subject><subject>Stents</subject><subject>Surgery (general aspects). Transplantations, organ and tissue grafts. 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To report early postmarket results with the PED.
This study was a prospective registry of patients treated with PEDs at 7 American neurosurgical centers subsequent to Food and Drug Administration approval of this device. Data collected included clinical presentation, aneurysm characteristics, treatment details, and periprocedural events. Follow-up data included degree of aneurysm occlusion and delayed (> 30 days after the procedure) complications.
Sixty-two PED procedures were performed to treat 58 aneurysms in 56 patients. Thirty-seven of the aneurysms (64%) treated were located from the cavernous to the superior hypophyseal artery segment of the internal carotid artery; 22% were distal to that segment, and 14% were in the vertebrobasilar system. A total of 123 PEDs were deployed with an average of 2 implanted per aneurysm treated. Six devices were incompletely deployed; in these cases, rescue balloon angioplasty was required. Six periprocedural (during the procedure/within 30 days after the procedure) thromboembolic events occurred, of which 5 were in patients with vertebrobasilar aneurysms. There were 4 fatal postprocedural hemorrhages (from 2 giant basilar trunk and 2 large ophthalmic artery aneurysms). The major complication rate (permanent disability/death resulting from perioperative/delayed complication) was 8.5%. Among 19 patients with 3-month follow-up angiography, 68% (13 patients) had complete aneurysm occlusion. Two patients presented with delayed flow-limiting in-stent stenosis that was successfully treated with angioplasty.
Unlike conventional coil embolization, aneurysm occlusion with PED is not immediate. Early complications include both thromboembolic and hemorrhagic events and appear to be significantly more frequent in association with treatment of vertebrobasilar aneurysms.</abstract><cop>Hagerstown, MD</cop><pub>Lippincott Williams & Wilkins</pub><pmid>22948199</pmid><doi>10.1227/NEU.0b013e31827060d9</doi><tpages>8</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0148-396X |
| ispartof | Neurosurgery, 2012-12, Vol.71 (6), p.1080-1087 |
| issn | 0148-396X 1524-4040 |
| language | eng |
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| source | MEDLINE; Journals@Ovid Complete |
| subjects | Aged Aneurysms Angioplasty Aspirin - therapeutic use Biological and medical sciences Blood Vessel Prosthesis Embolization Embolization, Therapeutic - instrumentation Embolization, Therapeutic - methods Female Fibrinolytic Agents - therapeutic use Follow-Up Studies Humans Intracranial Aneurysm - therapy Male Medical sciences Middle Aged Neurosurgery Postoperative Complications Product Surveillance, Postmarketing Retrospective Studies Stents Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases Thromboembolism Treatment Outcome United States |
| title | Early Postmarket Results After Treatment of Intracranial Aneurysms With the Pipeline Embolization Device: A US Multicenter Experience |
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