TY - JOUR
T1 - Safety and efficacy of the Pipeline Flex embolization device with Shield Technology for the acute treatment of ruptured internal carotid artery pseudoaneurysms
T2 - a multi-institution case series
AU - Bounajem, Michael T.
AU - Joyce, Evan
AU - Scoville, Jonathan P.
AU - Seinfeld, Joshua
AU - Hoffman, Jessa
AU - Grossberg, Jonathan A.
AU - Waiters, Vanesha
AU - White, Andrew C.
AU - Nerva, John
AU - Burkhardt, Jan Karl
AU - Tonetti, Daniel A.
AU - El Naamani, Kareem
AU - Gooch, M. Reid
AU - Jabbour, Pascal
AU - Tjoumakaris, Stavropoula
AU - Gutierrez, Santiago Ortega
AU - Levitt, Michael R.
AU - Lang, Michael
AU - Ares, William J.
AU - Desai, Sohum
AU - Mascitelli, Justin R.
AU - Kilburg, Craig J.
AU - Budohoski, Karol P.
AU - Couldwell, William T.
AU - Gross, Bradley A.
AU - Grandhi, Ramesh
N1 - Publisher Copyright:
© AANS 2023, except where prohibited by US copyright law
PY - 2023
Y1 - 2023
N2 - OBJECTIVE Ruptured blister, dissecting, and iatrogenic pseudoaneurysms are rare pathologies that pose significant challenges from a treatment standpoint. Endovascular treatment via flow diversion represents an increasingly popular option; however, drawbacks include the requirement for dual antiplatelet therapy and the potential for thromboembolic complications, particularly acute complications in the ruptured setting. The Pipeline Flex embolization device with Shield Technology (PED-Shield) offers reduced material thrombogenicity, which may aid in the treatment of ruptured internal carotid artery pseudoaneurysms. METHODS The authors conducted a multi-institution, retrospective case series to determine the safety and efficacy of PED-Shield for the treatment of ruptured blister, dissecting, and iatrogenic pseudoaneurysms of the internal carotid artery. Clinical, radiographic, treatment, and outcomes data were collected. RESULTS Thirty-three patients were included in the final analysis. Seventeen underwent placement of a single device, and 16 underwent placement of two devices. No thromboembolic complications occurred. Four patients were maintained on aspirin alone, and all others were treated with long-term dual antiplatelet therapy. Among patients with 3-month follow-up, 93.8% had a modified Rankin Scale score of 0–2. Complete occlusion at follow-up was observed in 82.6% of patients. CONCLUSIONS PED-Shield represents a new option for the treatment of ruptured blister, dissecting, and iatrogenic pseudoaneurysms of the internal carotid artery. The reduced material thrombogenicity appeared to improve the safety of the PED-Shield device, as this series demonstrated no thromboembolic complications even among patients treated with only single antiplatelet therapy. The efficacy of PED-Shield reported in this series, particularly with placement of two devices, demonstrates its potential as a first-line treatment option for these pathologies.
AB - OBJECTIVE Ruptured blister, dissecting, and iatrogenic pseudoaneurysms are rare pathologies that pose significant challenges from a treatment standpoint. Endovascular treatment via flow diversion represents an increasingly popular option; however, drawbacks include the requirement for dual antiplatelet therapy and the potential for thromboembolic complications, particularly acute complications in the ruptured setting. The Pipeline Flex embolization device with Shield Technology (PED-Shield) offers reduced material thrombogenicity, which may aid in the treatment of ruptured internal carotid artery pseudoaneurysms. METHODS The authors conducted a multi-institution, retrospective case series to determine the safety and efficacy of PED-Shield for the treatment of ruptured blister, dissecting, and iatrogenic pseudoaneurysms of the internal carotid artery. Clinical, radiographic, treatment, and outcomes data were collected. RESULTS Thirty-three patients were included in the final analysis. Seventeen underwent placement of a single device, and 16 underwent placement of two devices. No thromboembolic complications occurred. Four patients were maintained on aspirin alone, and all others were treated with long-term dual antiplatelet therapy. Among patients with 3-month follow-up, 93.8% had a modified Rankin Scale score of 0–2. Complete occlusion at follow-up was observed in 82.6% of patients. CONCLUSIONS PED-Shield represents a new option for the treatment of ruptured blister, dissecting, and iatrogenic pseudoaneurysms of the internal carotid artery. The reduced material thrombogenicity appeared to improve the safety of the PED-Shield device, as this series demonstrated no thromboembolic complications even among patients treated with only single antiplatelet therapy. The efficacy of PED-Shield reported in this series, particularly with placement of two devices, demonstrates its potential as a first-line treatment option for these pathologies.
KW - PED-Shield
KW - Pipeline embolization device
KW - flow diversion
KW - ruptured aneurysm
KW - single antiplatelet therapy
UR - http://www.scopus.com/inward/record.url?scp=85158026844&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85158026844&partnerID=8YFLogxK
U2 - 10.3171/2023.2.FOCUS233
DO - 10.3171/2023.2.FOCUS233
M3 - Article
C2 - 37127036
AN - SCOPUS:85158026844
SN - 1092-0684
VL - 54
JO - Neurosurgical focus
JF - Neurosurgical focus
IS - 5
M1 - E4
ER -