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Hemorrhagic stroke

Original research

Periprocedural safety of saccular aneurysm

embolization with the Penumbra SMART Coil System:
a SMART registry subset analysis
Robert M Starke,1 Min S Park,2 Richard Bellon,3 Bradley Bohnstedt  ‍ ‍,4
Clemens M Schirmer,5 Reade De Leacy  ‍ ‍,6 David Fiorella  ‍ ‍,7 Albert J Yoo,8
Alejandro M Spiotta,9 On behalf of the SMART Registry Investigators

►► Additional material is ABSTRACT The Penumbra SMART Coil System (SMART;

published online only. To view, Background  Using data from the SMART registry, Penumbra Inc., Alameda, USA) is a newer-­
please visit the journal online
(http://d​ x.​doi.o​ rg/​10.​1136/​ we report on periprocedural safety of the Penumbra generation coil system indicated for endovascular
neurintsurg-­​2020-­​016943). SMART Coil System for endovascular coil embolization of embolization in the peripheral and neuro vascula-
saccular intracranial aneurysms. ture. The system is comprised of the platinum coil,
For numbered affiliations see Methods  The SMART registry was a prospective, multi-­ a composite detachment pusher, and a detachment
end of article.
center registry of site standard of care endovascular handle. The coils are bare metal platinum and get
coiling procedures performed using at least 75% softer toward the proximal end to reduce microca-
Correspondence to
Dr Alejandro M Spiotta, Penumbra SMART Coil, PC400, and/or POD coils. theter deflection during delivery. Coil detachment
Neurosurgery, Medical This subset analysis reports on the periprocedural is performed mechanically using a coil detachment
University of South Carolina, safety outcomes of the saccular intracranial aneurysm handle.
Charleston, SC 29425, USA; ​ cohort. Predictors of rupture/re-­rupture or perforation The SMART registry was initiated in 2016 to
spiotta@​musc.​edu
(RRP), thromboembolic complications, and device- or prospectively evaluate the safety and efficacy of the
Received 28 September 2020 procedure-­related adverse events (AEs) were determined SMART system. Before this, the evaluation of the
Revised 30 December 2020 in univariate and multivariate analysis. SMART system was limited to small retrospective
Accepted 19 January 2021 Results  Between June 2016 and August 2018, 851 case series.5–8 A multicenter retrospective review
Published Online First saccular aneurysm patients (31.0%, 264/851 ruptured) of 59 aneurysm patients (44% ruptured) treated
16 February 2021
were enrolled across 66 North American centers. with at least one SMART coil between July 2015 to
Clinically significant (ie, a serious adverse event) RRP January 2016 by Spiotta et al7 achieved Raymond I
occurred in 2.0% (17/851) of cases – 1.9% (5/264) or II occlusion in 71.2% of patients with no device
for the ruptured cohort and 2.0% (12/587) for the un-­ malfunctions or rebleeds observed. Sokolowski et al5
ruptured cohort. Clinically significant thromboembolic investigated the follow-­up angiographic outcomes
events occurred in 3.1% (26/851) of cases – 5.3% of aneurysm embolization with SMART coils in a
(14/264) for the ruptured cohort and 2.0% (12/587) retrospective cohort. Of the 45 consecutive patients
for the un-­ruptured cohort. Multivariate predictors of treated with SMART coils during the study period,
periprocedural RRP were increased packing density and 33 patients with 34 aneurysms had angiographic
adjunctive treatment with a balloon. For periprocedural follow-­up. The initial modified Raymond–Roy
thromboembolic events, multivariate predictors were Classification (MRRC) was I, II, IIIa, and IIIb in
bifurcation location and ruptured status. For device- or 24%, 26%, 35%, and 15%, respectively. The overall
procedure-­related AEs, multivariate predictors were complication rate was 12%. At last follow-­up (mean
bifurcation location and adjunctive treatment with stent duration 7.7 ± 3.2 months), the retreatment rate
or balloon. was 14.7%, the MRRC was I, II, IIIa, and IIIb in
Conclusion  The low rates of thromboembolic 62%, 26%, 3%, and 9%, respectively. The authors
complications and RRP events demonstrate the adequate found that the majority of residual aneurysms after
safety profile of the SMART Coil System to treat cerebral the initial embolization procedure progressed to
aneurysms in routine clinical practice. complete or near-­ complete occlusion at interim
Trial registration number  NCT02729740. follow-­up. Daniel et al8 performed a single-­center
retrospective study of 49 aneurysm patients treated
primarily with SMART coil between July 2016
and August 2018. They achieved MRRC I or II in
© Author(s) (or their INTRODUCTION 91.8% of patients with five complications reported
employer(s)) 2022. Re-­use
permitted under CC BY-­NC. No Since its introduction in the 1990s, endovascular (one microcatheter prolapse and four thromboem-
commercial re-­use. See rights coiling technology has undergone several gener- bolic events with no clinical sequelae). No rupture
and permissions. Published ations of improvements and has become a widely and no technical malfunction were noted.
by BMJ. accepted, safe, and effective method for treating To our knowledge, the SMART registry is one
To cite: Starke RM, Park MS, intracranial vascular lesions.1–3 These lesions repre- of the largest coiling studies to date and is the
Bellon R, et al. sent a significant health burden, with aneurysms first study to gather safety and efficacy data for
J NeuroIntervent Surg alone affecting an estimated 1%–5% of the adult the SMART system coils in a prospective setting.
2022;14:51–56. population.4 Here we focus on the periprocedural safety and
Starke RM, et al. J NeuroIntervent Surg 2022;14:51–56. doi:10.1136/neurintsurg-2020-016943    51
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Hemorrhagic stroke
predictors of complications in the SMART registry’s saccular coils. Procedure-­related refers to the relationship to the overall
aneurysm cohort. This serves as a useful comparison to histor- procedure, coils, and/or other accessory devices (eg, microca-
ical trials9 10 (to demonstrate any changes to coiling performance theters, guidewires, stents, etc.).
over time), and other contemporary trials11 12 (to help physicians Wide-­necked aneurysms were defined as those with dome-­
make informed decisions about coil selection). to-­neck ratio <2 or neck width ≥4 mm. Distal locations were
defined as the anterior communicating artery and locations
METHODS distal to the middle cerebral artery (MCA) bifurcation. Bifur-
Overview cation locations were defined as the internal carotid artery
The SMART registry was a prospective, multi-­center registry terminus, MCA bifurcation, anterior communicating artery,
that included patients treated according to the cleared indi- and basilar artery bifurcation. Aneurysm occlusion status was
cations for SMART coils, Penumbra Coil 400 (PC 400), and measured angiographically using the Raymond–Roy Occlusion
POD. These indications include embolization of intracranial Classification (RROC). Class I is complete occlusion, Class II is a
aneurysms, and other neurovascular abnormalities such as arte- residual neck, and Class III is a residual aneurysm.13 The severity
riovenous malformation and arteriovenous fistulae. Exclusion of ruptured aneurysms at admission was determined by the Hunt
criteria were: life expectancy less than 1 year (ie, patients with and Hess scale.14
co-­morbidities that may result in a life expectancy less than
1 year were excluded: this exclusion did not apply to the aneu-
rysm disease state); and SMART, PC400, or POD account for
Statistical analysis
less than 75% of total number of coils implanted. Patients were Descriptive statistics were calculated for demographic, proce-
considered enrolled at the time of consent and the procedure dural, angiographic, and adverse event data, including the
began with the intent of implanting coils. Patients who failed to number of observations, mean, SD, median, IQR, minimum and
meet entry criteria pertaining to coil selection were considered a maximum for continuous variables, and counts and percentages
screen failure. If the case was emergent, then it was permissible for discrete variables.
to collect informed consent up to 1 calendar day after the proce- The associations of aneurysm and procedure characteristics to
dure. For all other cases, informed consent was required prior to periprocedural RRP, thromboembolic events, and procedure- or
the procedure. Endovascular coiling procedures were performed device-­related AEs were explored using univariate and multivar-
as per routine site standard of care. There were no restrictions iate modeling. A P-­value of <0.05 was chosen for significance,
regarding endovascular technique (eg, stent-­assistance, balloon-­ and correction for multiple testing was not performed. Cases
assistance, etc.) or use of adjunctive technologies. Institutional involving flow diverters were included in the stent-­ assisted
Review Board approval for each participating institution and coiling group for thromboembolic event and procedure- or
informed consent for all included patients were obtained. device-­related event predictive analyses. Multivariate analysis
This is a subset analysis of the SMART registry and includes was performed using a logistic regression model with a step-
only saccular aneurysm cases. Ninety patients with non-­aneurysm wise selection method using P<0.20 for entry and P≥0.05 for
cerebrovascular pathologies (arteriovenous malformation, arte- removal criteria. The analysis was done with SAS 9.4, and the
riovenous fistula, etc.) and 54 non-­saccular aneurysms (eg, pseu- maximum likelihood estimate of ORs, P-­values, and 95% CIs of
doaneurysm, fusiform, venous) were excluded. We report on the ORs are reported.
periprocedural safety and predictors of periprocedural rupture/
re-­
rupture/perforation (RRP), thromboembolic complications,
and device- or procedure-­related adverse events (AEs).
RESULTS
Between June 2016 and August 2018, the SMART registry
enrolled 851 saccular aneurysm patients across 66 centers in
Data collection North America (65 in the United States and one in Canada).
Demographics, medical history, procedural, angiographic, and
AE data were collected. AEs that were related to procedure
or device and all serious adverse events (SAEs) were collected Baseline characteristics
from the time of enrollment though registry exit. Safety data Baseline information and aneurysm characteristics are summa-
were reviewed by centralized monitors to ensure accurate event rized in tables 1 and 2, respectively. Of the included 851 saccular
reporting. aneurysm cases, 7.5% (64/851) were irregular saccular aneu-
rysms and 0.4% (3/851) were recurrent saccular aneurysms.
Study definitions Mean age ±SD was 59.9±12.5 years (n=851), 75.9% (646/851)
Periprocedural AEs were defined as events occurring during were female, 78.6% (221/281) were Caucasian, and 90.5%
or within 24 hours of the index procedure. Periprocedural (496/548) had pre-­morbid mRS 0–2. The majority of aneurysms
thromboembolic events were defined as events occurring were unruptured (69.0% [587/851]) and wide neck (63.1%
during or within 24 hours of the procedure regardless of pres- [526/833]). Size distribution was: 17.3% very small (<4 mm),
ence or absence of symptoms (eg, non-­occlusive clot event, 43.9% small (≥4 to<7 mm), 25.4% medium (≥7 to≤10 mm),
temporary intra-­ operative thromboembolism, stroke, etc.). 13.2% large (>10 to≤25 mm), and 0.2% giant (>25 mm). Loca-
Periprocedural RRP was defined as events occurring during tions were: 82.4% (701/851) anterior circulation and 17.6%
or within 24 hours of the procedure including symptomatic (150/851) posterior circulation. The most common location was
events and asymptomatic imaging findings for subarachnoid the intradural internal carotid artery (ICA, 38.0%), followed by
hemorrhage. The investigators determined the relationships the anterior cerebral artery (ACA, 30.7%). Bifurcation aneu-
of an AE to the device and procedure (definite, probable, rysms accounted for 49.8% (424/851) of cases, and distal aneu-
possible, unrelated). For this analysis, events reported as defi- rysms for 27.8% (237/851). Hunt and Hess grades at admission
nite, probable, or possible were considered as related. Device-­ for ruptured aneurysms were 79.6% (207/260) grades I–III and
related refers specifically to the relationship to Penumbra 20.4% (53/260) grades IV–V.
52 Starke RM, et al. J NeuroIntervent Surg 2022;14:51–56. doi:10.1136/neurintsurg-2020-016943
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Hemorrhagic stroke

Table 1  Baseline characteristics Table 2  Aneurysm characteristics

Characteristic Results Aneurysm characteristic Results
Demographics, mean±SD (range) or % (n/N) Location, % (n/N)
Age 59.9±12.5 (20–93) (n=851) ICA, Extradural 1.4% (12/851)
Female 75.9% (646/851)  Cervical  25.0% (3/12)
Race  Petrous  8.3% (1/12)
 White/Caucasian 78.6% (221/281)  Cavernous  66.7% (8/12)
 Black/African-­American 12.8% (36/281) ICA, Intradural 38.0% (323/851)
 Asian 2.1% (6/281)  Superior Hypophyseal  15.8% (51/323)
 Native American or Alaska Native 1.1% (3/281)  Ophthalmic  22.9% (74/323)
 Other 5.3% (15/281)  Posterior Communicating  49.5% (160/323)
Medical history, % (n/N)  Anterior Choroidal  3.1% (10/323)
 Smoking 63.3% (539/851)  ICA Terminus  8.7% (28/323)
 Diabetes 14.5% (123/851) ACA 30.7% (261/851)
 Hypertension 62.2% (529/851)  Proximal to anterior communicating  3.8% (10/261)
Pre-­morbid mRS, % (n/N)  Anterior communicating  87.4% (228/261)
 0 to 2 90.5% (496/548)  Pericallosal  8.8% (23/261)
 0 55.5% (304/548) MCA 12.3% (105/851)
 1 28.6% (157/548)  Proximal to MCA bifurcation  14.3% (15/105)
 2 6.4% (35/548)  MCA bifurcation  77.1% (81/105)
 3 2.6% (14/548)  Distal to MCA bifurcation  8.6% (9/105)
 4 4.0% (22/548) Posterior circulation 17.6% (150/851)
 5 2.9% (16/548)  Vertebral  8.0% (12/150)
Hunt and Hess score at admission*, %  Basilar trunk  6.0% (9/150)
(n/N)
 PICA  10.7% (16/150)
 I 21.9% (57/260)
 AICA  0.7% (1/150)
 II 33.5% (87/260)
 SCA  10.0% (15/150)
 III 24.2% (63/260)
 Basilar bifurcation  58.0% (87/150)
 IV 14.2% (37/260)
Distal location*, % (n/N) 27.8% (237/851)
 V 6.2% (16/260)
Bifurcation location†, % (n/N) 49.8% (424/851)
*Four ruptured aneurysm patients with missing Hunt and Hess Classification data
Aneurysm size, % (n/N)
 Giant (>25  mm) 0.2% (2/851)
Procedural characteristics  Large (>10 to ≤25 mm) 13.2% (112/851)
Procedure information is summarized in table 3. Coiling alone
 Medium (≥7 to ≤10 mm) 25.4% (216/851)
was used in 43.2% (368/851) of cases, and adjunctive therapy
was used in 56.8% (483/851) of cases (34.8% [296/851] stent-­  Small (≥4 to <7 mm) 43.9% (374/851)
assisted, 17.4% [148/851] balloon-­assisted, 2.8% [24/851] both  Very Small (<4 mm) 17.3% (147/851)
balloon- and stent-­assisted, and 1.8% [15/851] flow diverter Aneurysm neck size, % (n/N)
assisted. Mean fluoroscopic time was 43.4 mins±28.9 (n=848).
 Non-­wide-­neck 36.9% (307/833)
RROC class I–II at the end of the procedure was achieved in
80.3% (681/848) of cases.  Wide-­neck‡ 63.1% (526/833)
Aneurysm rupture status, % (n/N)
Mortality through discharge  Ruptured 31.0% (264/851)
Twenty-­two deaths (2.6%, 22/851) occurred before discharge.  Unruptured 69.0% (587/851)
Twenty deaths were in patients with ruptured aneurysms, of *Distal locations are defined as aneurysms located in the anterior communicating
which 95% were reported as unrelated to the device or proce- artery or located distal to the middle cerebral artery (MCA) bifurcation.
dure. Two deaths were in patients with unruptured aneurysms. †Bifurcation locations are defined as ICA terminus, MCA bifurcation, anterior
One was a 64-­ year-­
old woman with an unruptured anterior communicating artery, and basilar artery bifurcation.
communicating artery aneurysm (preloaded with clopidogrel ‡Wide neck defined as neck size ≥4mm or dome-­to-­neck ratio<2.
and aspirin, successfully treated with stent-­ assisted coiling). ACA, Anterior cerebral artery; AICA, Anterior inferior cerebellar artery; ICA, Internal
carotid artery; MCA, Middle cerebral artery; PICA, Posterior inferior cerebellar artery;
Post-­procedure, a small subarachnoid hemorrhage located in the SCA, Superior cerebellar artery.
interpeduncular cistern was identified. This hemorrhage rapidly
expanded over the course of several hours and the patient died.
The second was a 66-­year-­old woman with an unruptured poste-
rior communicating artery aneurysm who developed a right
frontal hemorrhagic stroke during inpatient recovery and died
Starke RM, et al. J NeuroIntervent Surg 2022;14:51–56. doi:10.1136/neurintsurg-2020-016943 53
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Hemorrhagic stroke

Table 3  Procedural characteristics Table 4  Periprocedural complications

Procedural characteristic Results Aneurysm
Total fluoroscopy time, mins mean±SD (range) 43.4±28.9 (3–266) Ruptured Un-­ruptured Overall
(n=848)
Access site
Overall procedure time*, mins mean±SD (range) 83.2±45.7 (11–370) complications, % (n/N)
(n=787)
Total 0.4% (1/264) 4.1% (24/587) 2.9% (25/851)
Day of procedure, % (n/N)
Event status*
 Weekday 93.4% (795/851)
 Not serious 0.4% (1/264) 3.7% (22/587) 2.7% (23/851)
 Weekend 6.6% (56/851)
 Serious 0.0% (0/264) 0.3% (2/587) 0.2% (2/851)
Packing density†, mean±SD (range) 32.3±18.3 (0.4–218.7)
Relationship†
(n=811)
 Procedure-r­ elated 0.4% (1/264) 4.1% (24/587) 2.9% (25/851)
Adjunctive techniques used, % (n/N)
 Device-­related 0.0% (0/264) 0.0% (0/587) 0.0% (0/851)
 Coils only 43.2% (368/851)
Aneurysm re-­
 Stent-a­ ssisted only 34.8% (296/851)
rupture/rupture or
 Balloon-a­ ssisted only 17.4% (148/851) perforation, % (n/N)
 Balloon-a­ ssisted and stent-­assisted 2.8% (24/851) Total 3.4% (9/264) 2.7% (16/587) 2.9% (25/851)
 Flow diverter-­assisted‡ 1.8% (15/851) Event status*
RROC at the end of the procedure, % (n/N)  Not serious 1.5% (4/264) 0.7% (4/587) 0.9% (8/851)
 Class I to II 80.3% (681/848)  Serious 1.9% (5/264) 2.0% (12/587) 2.0% (17/851)
 Class I 40.2% (341/848) Relationship†
 Class II 40.1% (340/848)  Procedure-­related 2.7% (7/264) 2.6% (15/587) 2.6% (22/851)
 Class III 19.7% (167/848)  Device-­related 2.3% (6/264)) 1.9% (11/587) 2.0% (17/851)
Re-­access attempts with guidewire due to catheter 6.2% (280/4517) Dissection, % (n/N)
kckout§, % (n/N)¶
Total 0.0% (0/264) 0.7% (4/587) 0.5% (4/851)
*Defined as time from arterial puncture to last coil detached
†For patients with constructively treated saccular aneurysm Event status*
‡For one patient, both balloon and flow-­diverter adjunctive techniques were used  Not serious 0.0% (0/264) 0.2% (1/587) 0.1% (1/851)
§For Penumbra coils only. Thirteen patients are missing re-­access information for
 Serious 0.0% (0/264) 0.5% (3/587) 0.4% (3/851)
Penumbra coils.
¶Reported by device (# of kickout occurrences over # of Penumbra coils used) Relationship†
RROC, Raymond–Roy Occlusion Classification.  Procedure-r­ elated 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)
3 weeks after the procedure from complications associated with
Thromboembolic events,
pre-­existing end-­stage renal disease.
% (n/N)
Total 8.3% (22/264) 3.6% (21/587) 5.1% (43/851)
Periprocedural (within 24 hours) rupture/re-rupture and
perforation Event status*
In the ruptured aneurysm cohort, periprocedural RRP occurred  Not serious 3.0% (8/264) 1.5% (9/587) 2.0% (17/851)
in 3.4% (9/264) of cases (1.9% [5/264] serious, 1.5% [4/264] not  Serious 5.3% (14/264) 2.0% (12/587) 3.1% (26/851)
serious). Site investigators reported that six were related to coils
Relationship†
(ie, device-­related). In the unruptured aneurysm cohort, peripro-
cedural RRP occurred in 2.7% (16/587) of cases (2.0% [12/587]  Procedure-­related 7.2% (19/264) 3.2% (19/587) 4.5% (38/851)
serious, 0.7% [4/587] not serious). Eleven were related to coils.  Device-­related 4.2% (11/264) 2.7% (16/587) 3.2% (27/851)
Details are available in table 4 and online supplemental table 4. *An event is reported as serious if it led to death or led to a serious deterioration in
In the multivariate model (including aneurysm size, location, the health of the patient that resulted in life-­threatening illness or injury, resulted
neck width, rupture status, weekend/weekday procedure, packing in permanent impairment of a body structure or body function, required inpatient
hospitalization or prolongation of existing hospitalization, or resulted in medical
density, and adjunctive device use), balloon-­assisted treatment (OR
or surgical intervention to arrest permanent impairment to body structure or body
6.92, 95% CI 2.15 to 22.28), and packing density per 5% increase function.
(OR 1.09, 95% CI 1.01 to 1.17) were independent predictors of †An event can be reported as both procedure- and device-­related. Any relationship
RRP. The full results of the univariate and multivariate predictive (possible, probable, or definite) besides unrelated was considered as related.
analyses are available in online supplemental table 1.
thromboembolic event occurred in 3.6% (21/587) of cases
Periprocedural (within 24 hours) thromboembolic events (2.0% [12/587] serious, 1.5% [9/587] not serious). Sixteen
In the ruptured aneurysm cohort, periprocedural thrombo- were related to coils. Adjunctive stents or flow diverters were
embolic events occurred in 8.3% (22/264) of cases (5.3% used in 61.9% (13/21) and balloons were used in 9.5% (2/21)
[14/264] serious, 3.0% [8/264] not serious). Eleven were of these cases. Details are available in table 4 and online
related to coils. Adjunctive stents or flow diverters were used in supplemental table 4.
13.6% (3/22) and balloons were used in 27.3% (6/22) of these In the multivariate model (including aneurysm size, loca-
cases. In the unruptured aneurysm cohort, a periprocedural tion, rupture status, neck width, weekend/weekday procedure,

54 Starke RM, et al. J NeuroIntervent Surg 2022;14:51–56. doi:10.1136/neurintsurg-2020-016943

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Hemorrhagic stroke
adjunctive device use, and patient age), bifurcation location of periprocedural thromboembolic events and RRP were
(OR 2.08, 95% CI 1.07 to 4.05) and ruptured status (OR 2.32, similar across these trials. For periprocedural thromboembolic
95% CI 1.23 to 4.38) were independent predictors of thrombo- events, rates were 4.7%, 5.6%, and 5.1%, and for RRP, rates
embolic events. The full results of the univariate and multivariate were 2.7%, 6.3%, and 2.9% in the TARGET, Barricade, and
predictive analyses are available in online supplemental table 2. SMART studies, respectively.

Periprocedural device- or procedure-related AEs Risk factors for periprocedural complications

In the multivariate model (including aneurysm size, location, We found that the risk of RRP increased with balloon assis-
neck width, rupture status, weekend/weekday procedure, tance. This association has been previously studied and
packing density, adjunctive device use, and patient age), bifurca- yielded mixed results – some authors have reported that
tion location (OR 1.82, 95% CI 1.24 to 2.65), balloon-­assisted balloon assistance is associated with increased risk while
adjunctive technique (OR 1.86, 95% CI 1.10 to 3.15), and stent-­ others determined not.15–19 These differences may be partly
assisted adjunctive technique (OR 1.79, 95% CI 1.18 to 2.73) due to technique variations between operators. An inflated
were independent predictors of device- or procedure-­ related balloon may reduce microcatheter tip deflection during coil
AEs. Full results of the univariate and multivariate predictive deployment. By increasing construct rigidity, force transfer
analyses are available in online supplemental table 3. to the dome could occur during coil introduction and there-
fore increase the likelihood of RRP. Alternatively, balloon
DISCUSSION placement before coiling can be useful for rapidly controlling
The SMART registry is one of the largest prospective coiling hemorrhage if a rupture does occur.
studies to date and includes ruptured aneurysm patients with Thromboembolic event occurrence was observed to be
severe Hunt and Hess scores. Aneurysm data from this registry higher with bifurcation and ruptured aneurysms. Using
provides a detailed understanding of bare metal platinum coils’ routine diffusion weighting MRI, Altay et al also found that
complications and efficacy in routine clinical practice and may thromboembolic events are significantly more likely with
serve as a useful comparison for studies involving other aneurysm ruptured aneurysms (vs unruptured) regardless of the coiling
treatment modalities (eg, clipping, flow diversion, intrasaccular technique used.20 Procedure- or device- related AEs were
devices). In the ruptured aneurysm cohort, rates of periproce- more likely with bifurcation aneurysms, and in cases using
dural thromboembolic events and RRP were 8.3% (22/264) and balloon or stent assistance. This may be because increasing
3.4% (9/264), respectively. In the unruptured aneurysm cohort, the number of devices increases procedural complexity.
these rates were 3.6% (21/587) and 2.7% (16/587), respectively. Similarly, procedural complexity is higher with bifurcation
We used the CLARITY9 and ATENA10 studies as a histor- aneurysms than with simple sidewall aneurysms.21 Day of the
ical comparison for the ruptured and unruptured cohorts of procedure (weekend vs weekday) was not predictive of any
the SMART registry, respectively. CLARITY and ATENA are of the investigated complications, including procedure- or
chosen due to their large sample sizes and inclusion of subjects device-­related AEs. This may be a reflection of general trends
based on on-­site routine practice – which is a similar design to toward increased coiling case volume and therefore coiling
the SMART registry. However, study design differences make proficiency.22
direct comparison imprecise. Most notably, the CLARITY
and ATENA studies excluded aneurysms>15 mm in size and/ Limitations and strengths of the SMART registry
or patients outside the ages of 18–80. In contrast, SMART The SMART registry’s primary limitation is a function of its
did not restrict enrollment by age or size;: ages ranged from design, the lack of a randomized controlled comparison. Addi-
20 to 93 years' old and large or giant aneurysms comprised tionally, there was no independent core laboratory to review
13.4% of the population. imaging endpoints and emergent cases could be enrolled up
The CLARITY trial (a multicenter prospective ruptured to 1 day after the procedure, allowing for potential selection
aneurysm GDC coils study) had a thromboembolic event bias. Strengths of this study include the prospective nature,
rate of 13.3% (54/405) and an RRP rate of 3.7% (15/405).9 and large sample size. Data was monitored via on-­site visits
The ATENA study (an international multicenter prospective to ensure consistency and accuracy of reported information.
unruptured aneurysm coiling study) reported a thromboem- The registry was designed to follow site routine standards
bolic event rate of 7.1% (50/700) and an RRP rate of 2.6% of care in order for the results to reflect real-­world clinical
(18/700).10 Lower rates of thromboembolic events were practice.
observed in the SMART registry despite the registry’s higher
rate of stent assistance (37.6%) as compared with CLARITY CONCLUSION
(0.5%) and ATENA (7.8%). Optimization of antiplatelet The low rates of thromboembolic complications and RRP
regimens, updated embolization techniques, advances in events demonstrate the adequate safety profile of the SMART
guide catheter technology, improved coil conformability, and Coil System to treat cerebral aneurysms in routine clinical
reduced coil protrusion may contribute to the SMART regis- practice.
try’s lower thromboembolic event rate.
Two notable contemporary studies involving bare platinum Author affiliations
1
coils are the TARGET registry, and a single-­center series inves- Neurological Surgery, University of Miami Hospital, Miami, Florida, USA
2
tigating Barricade coils.11 12 The TARGET registry limited Neurosurgery, University of Virginia, Charlottesville, Virginia, USA
3
Interventional Neuroradiology, Radiology Imaging Associates, Englewood, Colorado,
enrollment to patients with pre-­morbid mRS ≤3 and Hunt USA
and Hess≤3, while neither SMART nor the Barricade series 4
Department of Neurological Surgery, Oklahoma University Medical Center,
had this restriction. Approximately 20.4% of the ruptured Oklahoma City, Oklahoma, USA
5
aneurysm cases in the SMART registry had Hunt and Hess Neurosurgery, Geisinger Health System, Danville, Pennsylvania, USA
6
Neurosurgery and Radiology, Icahn School of Medicine at Mount Sinai, New York
scores of 4 or 5. All three studies were of prospective design
City, New York, USA
and included ruptured and unruptured aneurysms. The rates
Starke RM, et al. J NeuroIntervent Surg 2022;14:51–56. doi:10.1136/neurintsurg-2020-016943 55
 J NeuroIntervent Surg: first published as 10.1136/neurintsurg-2020-016943 on 16 February 2021. Downloaded from http://jnis.bmj.com/ on March 26, 2023 by guest. Protected by copyright.
Hemorrhagic stroke
7
8
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56 Starke RM, et al. J NeuroIntervent Surg 2022;14:51–56. doi:10.1136/neurintsurg-2020-016943