TY - JOUR
T1 - Early postmarket results with PulseRider for treatment of wide-necked intracranial aneurysms
T2 - A multicenter experience
AU - Srinivasan, Visish M.
AU - Srivatsan, Aditya
AU - Spiotta, Alejandro M.
AU - Hendricks, Benjamin K.
AU - Ducruet, Andrew F.
AU - Albuquerque, Felipe C.
AU - Puri, Ajit
AU - Amans, Matthew R.
AU - Hetts, Steven W.
AU - Cooke, Daniel L.
AU - Ogilvy, Christopher S.
AU - Thomas, Ajith J.
AU - Enriquez-Marulanda, Alejandro
AU - Rai, Ansaar
AU - Boo, So Hyun
AU - Carlson, Andrew P.
AU - Crowley, R. Webster
AU - Rangel-Castilla, Leonardo
AU - Lanzino, Giuseppe
AU - Chen, Peng Roc
AU - Diaz, Orlando
AU - Bohnstedt, Bradley N.
AU - O'Connor, Kyle P.
AU - Burkhardt, Jan Karl
AU - Johnson, Jeremiah N.
AU - Chen, Stephen R.
AU - Kan, Peter
N1 - Publisher Copyright:
© AANS 2020.
PY - 2020/12
Y1 - 2020/12
N2 - OBJECTIVE Traditionally, stent-assisted coiling and balloon remodeling have been the primary endovascular treatments for wide-necked intracranial aneurysms with complex morphologies. PulseRider is an aneurysm neck reconstruction device that provides parent vessel protection for aneurysm coiling. The objective of this study was to report early postmarket results with the PulseRider device. METHODS This study was a prospective registry of patients treated with PulseRider at 13 American neurointerventional centers following FDA approval of this device. Data collected included clinical presentation, aneurysm characteristics, treatment details, and perioperative events. Follow-up data included degree of aneurysm occlusion and delayed (> 30 days after the procedure) complications. RESULTS A total of 54 aneurysms were treated, with the same number of PulseRider devices, across 13 centers. Fourteen cases were in off-label locations (7 anterior communicating artery, 6 middle cerebral artery, and 1 A1 segment anterior cerebral artery aneurysms). The average dome/neck ratio was 1.2. Technical success was achieved in 52 cases (96.2%). Major complications included the following: 3 procedure-related posterior cerebral artery strokes, a devicerelated intraoperative aneurysm rupture, and a delayed device thrombosis. Immediately postoperative Raymond-Roy occlusion classification (RROC) class 1 was achieved in 21 cases (40.3%), class 2 in 15 (28.8%), and class 3 in 16 cases (30.7%). Additional devices were used in 3 aneurysms. For those patients with 3- or 6-month angiographic follow-up (28 patients), 18 aneurysms (64.2%) were RROC class 1 and 8 (28.5%) were RROC class 2. CONCLUSIONS PulseRider is being used in both on- and off-label cases following FDA approval. The clinical and radiographic outcomes are comparable in real-world experience to the outcomes observed in earlier studies. Further experience is needed with the device to determine its role in the neurointerventionalist's armamentarium, especially with regard to its off-label use.
AB - OBJECTIVE Traditionally, stent-assisted coiling and balloon remodeling have been the primary endovascular treatments for wide-necked intracranial aneurysms with complex morphologies. PulseRider is an aneurysm neck reconstruction device that provides parent vessel protection for aneurysm coiling. The objective of this study was to report early postmarket results with the PulseRider device. METHODS This study was a prospective registry of patients treated with PulseRider at 13 American neurointerventional centers following FDA approval of this device. Data collected included clinical presentation, aneurysm characteristics, treatment details, and perioperative events. Follow-up data included degree of aneurysm occlusion and delayed (> 30 days after the procedure) complications. RESULTS A total of 54 aneurysms were treated, with the same number of PulseRider devices, across 13 centers. Fourteen cases were in off-label locations (7 anterior communicating artery, 6 middle cerebral artery, and 1 A1 segment anterior cerebral artery aneurysms). The average dome/neck ratio was 1.2. Technical success was achieved in 52 cases (96.2%). Major complications included the following: 3 procedure-related posterior cerebral artery strokes, a devicerelated intraoperative aneurysm rupture, and a delayed device thrombosis. Immediately postoperative Raymond-Roy occlusion classification (RROC) class 1 was achieved in 21 cases (40.3%), class 2 in 15 (28.8%), and class 3 in 16 cases (30.7%). Additional devices were used in 3 aneurysms. For those patients with 3- or 6-month angiographic follow-up (28 patients), 18 aneurysms (64.2%) were RROC class 1 and 8 (28.5%) were RROC class 2. CONCLUSIONS PulseRider is being used in both on- and off-label cases following FDA approval. The clinical and radiographic outcomes are comparable in real-world experience to the outcomes observed in earlier studies. Further experience is needed with the device to determine its role in the neurointerventionalist's armamentarium, especially with regard to its off-label use.
KW - Aneurysm
KW - Basilar apex
KW - Basilar tip
KW - Bifurcation
KW - Broad neck
KW - Coiling
KW - PulseRider
KW - Stent
KW - Vascular disorders
KW - Wide neck
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U2 - 10.3171/2019.5.JNS19313
DO - 10.3171/2019.5.JNS19313
M3 - Article
C2 - 31703202
AN - SCOPUS:85097150360
SN - 0022-3085
VL - 133
SP - 1756
EP - 1765
JO - Journal of Neurosurgery
JF - Journal of Neurosurgery
IS - 6
ER -