| Literature DB >> 33593799 |
Robert M Starke1, Min S Park2, Richard Bellon3, Bradley Bohnstedt4, Clemens M Schirmer5, Reade De Leacy6, David Fiorella7, Albert J Yoo8, Alejandro M Spiotta9.
Abstract
BACKGROUND: Using data from the SMART registry, we report on periprocedural safety of the Penumbra SMART Coil System for endovascular coil embolization of saccular intracranial aneurysms.Entities:
Keywords: aneurysm; coil; complication; device; intervention
Mesh:
Year: 2021 PMID: 33593799 PMCID: PMC8785012 DOI: 10.1136/neurintsurg-2020-016943
Source DB: PubMed Journal: J Neurointerv Surg ISSN: 1759-8478 Impact factor: 5.836
Procedural characteristics
| Procedural characteristic | Results |
| Total fluoroscopy time, mins mean±SD (range) | 43.4±28.9 (3–266) |
| Overall procedure time*, mins mean±SD (range) | 83.2±45.7 (11–370) |
| Day of procedure, % (n/N) | |
| Weekday | 93.4% (795/851) |
| Weekend | 6.6% (56/851) |
| Packing density†, mean±SD (range) | 32.3±18.3 (0.4–218.7) |
| Adjunctive techniques used, % (n/N) | |
| Coils only | 43.2% (368/851) |
| Stent-assisted only | 34.8% (296/851) |
| Balloon-assisted only | 17.4% (148/851) |
| Balloon-assisted and stent-assisted | 2.8% (24/851) |
| Flow diverter-assisted‡ | 1.8% (15/851) |
| RROC at the end of the procedure, % (n/N) | |
| Class I to II | 80.3% (681/848) |
| Class I | 40.2% (341/848) |
| Class II | 40.1% (340/848) |
| Class III | 19.7% (167/848) |
| Re-access attempts with guidewire due to catheter kckout§, % (n/N)¶ | 6.2% (280/4517) |
*Defined as time from arterial puncture to last coil detached
†For patients with constructively treated saccular aneurysm
‡For one patient, both balloon and flow-diverter adjunctive techniques were used
§For Penumbra coils only. Thirteen patients are missing re-access information for Penumbra coils.
¶Reported by device (# of kickout occurrences over # of Penumbra coils used)
RROC, Raymond–Roy Occlusion Classification.
Periprocedural complications
| Aneurysm | |||
| Ruptured | Un-ruptured | Overall | |
|
| |||
| Total | 0.4% (1/264) | 4.1% (24/587) | 2.9% (25/851) |
| Event status* | |||
| Not serious | 0.4% (1/264) | 3.7% (22/587) | 2.7% (23/851) |
| Serious | 0.0% (0/264) | 0.3% (2/587) | 0.2% (2/851) |
| Relationship† | |||
| Procedure-related | 0.4% (1/264) | 4.1% (24/587) | 2.9% (25/851) |
| Device-related | 0.0% (0/264) | 0.0% (0/587) | 0.0% (0/851) |
|
| |||
| Total | 3.4% (9/264) | 2.7% (16/587) | 2.9% (25/851) |
| Event status* | |||
| Not serious | 1.5% (4/264) | 0.7% (4/587) | 0.9% (8/851) |
| Serious | 1.9% (5/264) | 2.0% (12/587) | 2.0% (17/851) |
| Relationship† | |||
| Procedure-related | 2.7% (7/264) | 2.6% (15/587) | 2.6% (22/851) |
| Device-related | 2.3% (6/264)) | 1.9% (11/587) | 2.0% (17/851) |
|
| |||
| Total | 0.0% (0/264) | 0.7% (4/587) | 0.5% (4/851) |
| Event status* | |||
| Not serious | 0.0% (0/264) | 0.2% (1/587) | 0.1% (1/851) |
| Serious | 0.0% (0/264) | 0.5% (3/587) | 0.4% (3/851) |
| Relationship† | |||
| Procedure-related | 0.0% (0/264) | 0.7% (4/587) | 0.5% (4/851) |
| Device-related | 0.0% (0/264) | 0.0% (0/587) | 0.0% (0/851) |
|
| |||
| Total | 8.3% (22/264) | 3.6% (21/587) | 5.1% (43/851) |
| Event status* | |||
| Not serious | 3.0% (8/264) | 1.5% (9/587) | 2.0% (17/851) |
| Serious | 5.3% (14/264) | 2.0% (12/587) | 3.1% (26/851) |
| Relationship† | |||
| Procedure-related | 7.2% (19/264) | 3.2% (19/587) | 4.5% (38/851) |
| Device-related | 4.2% (11/264) | 2.7% (16/587) | 3.2% (27/851) |
*An event is reported as serious if it led to death or led to a serious deterioration in the health of the patient that resulted in life-threatening illness or injury, resulted in permanent impairment of a body structure or body function, required inpatient hospitalization or prolongation of existing hospitalization, or resulted in medical or surgical intervention to arrest permanent impairment to body structure or body function.
†An event can be reported as both procedure- and device-related. Any relationship (possible, probable, or definite) besides unrelated was considered as related.
Baseline characteristics
| Characteristic | Results |
|
| |
| Age | 59.9±12.5 (20–93) (n=851) |
| Female | 75.9% (646/851) |
| Race | |
| White/Caucasian | 78.6% (221/281) |
| Black/African-American | 12.8% (36/281) |
| Asian | 2.1% (6/281) |
| Native American or Alaska Native | 1.1% (3/281) |
| Other | 5.3% (15/281) |
|
| |
| Smoking | 63.3% (539/851) |
| Diabetes | 14.5% (123/851) |
| Hypertension | 62.2% (529/851) |
|
| |
| 0 to 2 | 90.5% (496/548) |
| 0 | 55.5% (304/548) |
| 1 | 28.6% (157/548) |
| 2 | 6.4% (35/548) |
| 3 | 2.6% (14/548) |
| 4 | 4.0% (22/548) |
| 5 | 2.9% (16/548) |
|
| |
| I | 21.9% (57/260) |
| II | 33.5% (87/260) |
| III | 24.2% (63/260) |
| IV | 14.2% (37/260) |
| V | 6.2% (16/260) |
*Four ruptured aneurysm patients with missing Hunt and Hess Classification data
Aneurysm characteristics
| Aneurysm characteristic | Results |
|
| |
| ICA, Extradural | 1.4% (12/851) |
| Cervical | 25.0% (3/12) |
| Petrous | 8.3% (1/12) |
| Cavernous | 66.7% (8/12) |
| ICA, Intradural | 38.0% (323/851) |
| Superior Hypophyseal | 15.8% (51/323) |
| Ophthalmic | 22.9% (74/323) |
| Posterior Communicating | 49.5% (160/323) |
| Anterior Choroidal | 3.1% (10/323) |
| ICA Terminus | 8.7% (28/323) |
| ACA | 30.7% (261/851) |
| Proximal to anterior communicating | 3.8% (10/261) |
| Anterior communicating | 87.4% (228/261) |
| Pericallosal | 8.8% (23/261) |
| MCA | 12.3% (105/851) |
| Proximal to MCA bifurcation | 14.3% (15/105) |
| MCA bifurcation | 77.1% (81/105) |
| Distal to MCA bifurcation | 8.6% (9/105) |
| Posterior circulation | 17.6% (150/851) |
| Vertebral | 8.0% (12/150) |
| Basilar trunk | 6.0% (9/150) |
| PICA | 10.7% (16/150) |
| AICA | 0.7% (1/150) |
| SCA | 10.0% (15/150) |
| Basilar bifurcation | 58.0% (87/150) |
|
| 27.8% (237/851) |
|
| 49.8% (424/851) |
|
| |
| Giant (>25 mm) | 0.2% (2/851) |
| Large (>10 to ≤25 mm) | 13.2% (112/851) |
| Medium (≥7 to ≤10 mm) | 25.4% (216/851) |
| Small (≥4 to <7 mm) | 43.9% (374/851) |
| Very Small (<4 mm) | 17.3% (147/851) |
|
| |
| Non-wide-neck | 36.9% (307/833) |
| Wide-neck‡ | 63.1% (526/833) |
|
| |
| Ruptured | 31.0% (264/851) |
| Unruptured | 69.0% (587/851) |
*Distal locations are defined as aneurysms located in the anterior communicating artery or located distal to the middle cerebral artery (MCA) bifurcation.
†Bifurcation locations are defined as ICA terminus, MCA bifurcation, anterior communicating artery, and basilar artery bifurcation.
‡Wide neck defined as neck size ≥4mm or dome-to-neck ratio<2.
ACA, Anterior cerebral artery; AICA, Anterior inferior cerebellar artery; ICA, Internal carotid artery; MCA, Middle cerebral artery; PICA, Posterior inferior cerebellar artery; SCA, Superior cerebellar artery.