Neurosurgery 87 (6) 2020: 1148–1156
Wide-necked cerebral aneurysms in the setting of acute subarachnoid hemorrhage (SAH) remain difficult to treat with endovascular methods despite recent progress in the neuroendovascular field.
OBJECTIVE: To evaluate the effectiveness and safety of the Comaneci device (Rapid Medical, Israel) in endovascular coil embolization of acutely ruptured, wide-necked sidewall, or bifurcation cerebral aneurysms.
METHODS: We retrospectively reviewed 45 anterior communicating artery, 24 internal carotid artery, 21 middle cerebral artery bifurcation, 15 anterior cerebral artery, and 13 posterior circulation aneurysms, which were treated using Comaneci-assisted coil embolization from August 2017 to January 2019. We evaluated procedural complications, clinical outcomes, and mid-term angiographic follow-up. Immediate and 90 d-clinical outcome and radiological follow-up were obtained in all patients.
RESULTS: Comaneci-assisted coil embolization was performed in 118 acutely ruptured aneurysms. The technique was carried out successfully in all cases. Simultaneous application of 2 separated Comaneci devices was performed in 8/118 cases (6.77%). Periprocedural thromboembolic complications related to the devicewere seen in 7/118 cases (5.93%) and severe vasospasm of the parent artery after manipulation of the Comaneci device occurred in 5/118 cases (4.2%). The procedural-relatedmorbidity rate was 2.54%, and there was no procedural related mortality. Among the available survivors, angiographic followups were obtained at 3 and 6 mo, and complete aneurysmal obliteration was confirmed in 81/112 (72.3%) and 75/112 (66.9%) cases, respectively. Mid-term follow-up reviewed total recanalization rate of 14.28%.
CONCLUSION: Comaneci-assisted embolization of wide-necked intracranial aneurysms in patients presenting with acute SAHis associated with high procedural safety and adequate occlusion rates. Furthermore, dual antiplatelet therapy can be safely avoided in this patient group.
Neurosurgery 87:63–70, 2020
Flow diverters (FDs) have marked the beginning of innovations in the endovascular treatment of large unruptured intracranial aneurysms, but no multiinstitutional studies have been conducted on these devices from both the clinical and economic perspectives.
OBJECTIVE: To compare retreatment rates and healthcare expenditures between FDs and conventional coiling-based treatments in all eligible cases in Japan.
METHODS: We identified patients who had undergone endovascular treatments during the study period (October 2015-March 2018) from a national-level claims database. The outcome measures were retreatment rates and 1-yr total healthcare expenditures, which were compared among patientswho had undergone FD, coiling, and stent-assisted coiling (SAC) treatments. The coiling and SAC groups were further categorized according to the number of coils used. Retreatment rates were analyzed using Cox proportional hazards models, and total expenditures were analyzed using multilevel mixed-effects generalized linear models.
RESULTS: The study sample comprised 512 FD patients, 1499 coiling patients, and 711 SAC patients. The coiling groups with ≥10 coils and ≥9 coils had significantly higher retreatment rates than the FD group with hazard ratios of 2.75 (1.30-5.82) and 2.52 (1.24-5.09), respectively. In addition, the coiling group with≥10 coils and SAC group with≥10 coils had significantly higher 1-year expenditures than the FD group with cost ratios (95% CI) of 1.30 (1.13-1.49) and 1.31 (1.15-1.50), respectively.
CONCLUSION: In this national-level study, FDs demonstrated significantly lower retreatment rates and total expenditures than conventional coiling with ≥ 9 coils.
Neurosurgery 86:615–624, 2020
Aneurysm recurrence after coiling has been associated with aneurysm growth, (re)hemorrhage, and a greater need for follow-up. The second-generation HydroCoil Embolic System (HES; MicroVention, Inc) consists of a platinum core with integrated hydrogel and was developed to reduce recurrence through enhancing packing density and healing within the aneurysm.
OBJECTIVE: To compare recurrence between the second-generation HES and bare platinum coil (BPC) in the new-generation Hydrogel Endovascular Aneurysm Treatment Trial (HEAT).
METHODS: HEAT is a randomized, controlled trial that enrolled subjects with ruptured or unruptured 3- to 14-mm intracranial aneurysms amenable to coiling. The primary endpoint was aneurysm recurrence using the Raymond-Roy scale. Secondary endpoints included minor and major recurrence, packing density, adverse events related to the procedure and/or device, mortality, initial complete occlusion, aneurysm retreatment, hemorrhage fromtarget aneurysm during follow-up, aneurysmocclusion stability, and clinical outcome at final follow-up.
RESULTS: A total of 600 patients were randomized (HES, n = 297 and BPC, n = 303), including 28% with ruptured aneurysms. Recurrence occurred in 11 (4.4%) subjects in the HES arm and 44 (15.4%) subjects in the BPC arm (P = .002). While the initial occlusion rate was higher with BPC, the packing density and both major and minor recurrence rates were in favor of HES. Secondary endpoints including adverse events, retreatment, hemorrhage, mortality, and clinical outcome did not differ between arms.
CONCLUSION: Coiling of small-to-medium aneurysms with second-generation HES resulted in less recurrence when compared to BPC, without increased harm. These data further support the use of the second-generation HES for the embolization of intracranial aneurysms.
J Neurosurg 132:771–776, 2020
The authors present the 10-year results of the Barrow Ruptured Aneurysm Trial (BRAT) for saccular aneurysms. The 1-, 3-, and 6-year results of the trial have been previously reported, as have the 6-year results with respect to saccular aneurysms. This final report comparing the safety and efficacy of clipping versus coiling is limited to an analysis of those patients presenting with subarachnoid hemorrhage (SAH) from a ruptured saccular aneurysm.
METHODS In the study, 362 patients had saccular aneurysms and were randomized equally to the clipping and the coiling cohorts (181 each). The primary outcome analysis was based on the assigned treatment group; poor outcome was defined as a modified Rankin Scale (mRS) score > 2 and was independently adjudicated. The extent of aneurysm obliteration was adjudicated by a nontreating neuroradiologist.
RESULTS There was no statistically significant difference in poor outcome (mRS score > 2) or deaths between these 2 treatment arms during the 10 years of follow-up. Of 178 clip-assigned patients with saccular aneurysms, 1 (< 1%) was crossed over to coiling, and 64 (36%) of the 178 coil-assigned patients were crossed over to clipping. After the initial hospitalization, 2 of 241 (0.8%) clipped saccular aneurysms and 23 of 115 (20%) coiled saccular aneurysms required retreatment (p < 0.001). At the 10-year follow-up, 93% (50/54) of the clipped aneurysms were completely obliterated, compared with only 22% (5/23) of the coiled aneurysms (p < 0.001). Two patients had documented rebleeding, both died, and both were in the assigned and treated coiled cohort (2/83); no patient in the clipped cohort (0/175) died (p = 0.04). In 1 of these 2 patients, the hemorrhage was not from the target aneurysm but from an incidental basilar artery aneurysm, which was coiled at the same time.
CONCLUSIONS There was no significant difference in clinical outcomes between the 2 assigned treatment groups as measured by mRS outcomes or deaths. Clinical outcomes in the patients with posterior circulation aneurysms were better in the coiling group at 1 year, but after 1 year this difference was no longer statistically significant. Rates of complete aneurysm obliteration and rates of retreatment favored patients who actually underwent clipping compared with those who underwent coiling. Clinical trial registration no.: NCT01593267 (clinicaltrials.gov)
J Neurosurg 128:120–125, 2018
The Barrow Ruptured Aneurysm Trial (BRAT) is a prospective, randomized trial in which treatment with clipping was compared to treatment with coil embolization. Patients were randomized to treatment on presentation with any nontraumatic subarachnoid hemorrhage (SAH). Because all other randomized trials comparing these 2 types of treatments have been limited to saccular aneurysms, the authors analyzed the current BRAT data for this subgroup of lesions.
METHODS The primary BRAT analysis included all sources of SAH: nonaneurysmal lesions; saccular, blister, fusiform, and dissecting aneurysms; and SAHs from an aneurysm associated with either an arteriovenous malformation or a fistula. In this post hoc review, the outcomes for the subgroup of patients with saccular aneurysms were further analyzed by type of treatment. The extent of aneurysm obliteration was adjudicated by an independent neuroradiologist not involved in treatment.
RESULTS Of the 471 patients enrolled in the BRAT, 362 (77%) had an SAH from a saccular aneurysm. Patients with saccular aneurysms were assigned equally to the clipping and the coiling cohorts (181 each). In each cohort, 3 patients died before treatment and 178 were treated. Of the 178 clip-assigned patients with saccular aneurysms, 1 (1%) was crossed over to coiling, and 64 (36%) of the 178 coil-assigned patients were crossed over to clipping. There was no statistically significant difference in poor outcome (modified Rankin Scale score > 2) between these 2 treatment arms at any recorded time point during 6 years of follow-up. After the initial hospitalization, 1 of 241 (0.4%) clipped saccular aneurysms and 21 of 115 (18%) coiled saccular aneurysms required retreatment (p < 0.001). At the 6-year follow-up, 95% (95/100) of the clipped aneurysms were completely obliterated, compared with 40% (16/40) of the coiled aneurysms (p < 0.001). There was no difference in morbidity between the 2 treatment groups (p = 0.10).
CONCLUSIONS In the subgroup of patients with saccular aneurysms enrolled in the BRAT, there was no significant difference between modified Rankin Scale outcomes at any follow-up time in patients with saccular aneurysms assigned to clipping compared with those assigned to coiling (intent-to-treat analysis). At the 6-year follow-up evaluation, rates of retreatment and complete aneurysm obliteration significantly favored patients who underwent clipping compared with those who underwent coiling. Clinical trial registration no.: NCT01593267 (clinicaltrials.gov)
Neurosurgery 77:931–939, 2015
Previous studies have attempted to determine the best treatment for oculomotor nerve palsy (ONP) secondary to posterior communicating artery (PCoA) aneurysms, but have been limited by small sample sizes and limited treatment.
OBJECTIVE: To analyze the treatment of ONP secondary to PCoA with both coiling and clipping in ruptured and unruptured aneurysms.
METHODS: Data from 2 large academic centers was retrospectively collected over 22 years, yielding a total of 93 patients with ONP secondary to PCoA aneurysms. These patients were combined with 321 patients from the literature review for large data analyses. Onset symptoms, recovery, and time to resolution were evaluated with respect to treatment and aneurysm rupture status.
RESULTS: For all patients presenting with ONP (n = 414) 56.6% of those treated with microsurgical clipping made a full recovery vs 41.5% of those treated with endovascular coil embolization (P = .02). Of patients with a complete ONP (n = 229), full recovery occurred in 47.3% of those treated with clipping but in only 20% of those undergoing coiling (P = .01). For patients presenting with ruptured aneurysms (n = 130), full recovery occurred in 70.9% compared with 49.3% coiled patients (P = .01). Additionally, although patients with full ONP recovery had a median time to treatment of 4 days, those without full ONP recovery had a median time to treatment of 7 days (P = .01).
CONCLUSION: Patients with ONP secondary to PCoA aneurysms treated with clipping showed higher rates of full ONP resolution than patients treated with coil embolization. Larger prospective studies are needed to determine the true potential of recovery associated with each treatment.
J Neurosurg 123:609–617, 2015
The authors report the 6-year results of the Barrow Ruptured Aneurysm Trial (BRAT). This ongoing randomized trial, with the final goal of a 10-year follow-up, compares the safety and efficacy of surgical clip occlusion and endovascular coil embolization in patients presenting with subarachnoid hemorrhage (SAH) from a ruptured aneurysm. The 1- and 3-year results of this trial have been previously reported.
Methods In total, 500 patients with an SAH met the entry criteria and were enrolled in the study. Of these patients, 471 were randomly assigned to the treatments: 238 to surgical clipping and 233 to endovascular coiling. Six patients who died before treatment and 57 patients with nonaneurysmal SAHs were excluded, leaving a total of 408 patients who underwent clipping (209 assigned) or coiling (199 assigned). Whether to treat patients within the assigned group or to cross over patients to the other group was at the discretion of the treating physician; 38% (75/199) of the patients assigned to coiling were crossed over to clipping and 1.9% (4/209) assigned to clipping were crossed over to coiling. The outcome data were collected by a dedicated nurse practitioner. The primary outcome analysis was based on the assigned treatment group; poor outcome was defined as a modified Rankin Scale (mRS) score > 2 and was independently adjudicated. Six years after randomization, 336 (82%) of 408 patients who had been treated were available for examination.
Results On the basis of an mRS score of > 2, and similar to the results at the 3-year follow-up, no significant difference in outcomes (p = 0.24) was detected between the 2 treatment groups. Complete aneurysm obliteration at 6 years was achieved in 96% (111/116) of the clipping group and in 48% (23/48) of the coiling group (p < 0.0001). In the period between the 3- and 6-year follow-ups, 3 additional patients assigned to coiling and none assigned to clipping received retreatment, for overall retreatment rates of 4.6% (13/280) for clipping and 16.4% (21/128) for coiling (p < 0.0001). When aneurysm location was considered, the 6-year results continued to match the previously reported results, with no difference in outcome for anterior circulation aneurysms at most time points. Of the anterior circulation aneurysms assigned to coiling treatment, 42% (70/168) were crossed over to clipping treatment. The outcomes for posterior circulation aneurysms continued to favor coiling. The randomization process was unexpectedly skewed, with 18 of 21 treated aneurysms of the posterior inferior cerebellar artery (PICA) being assigned to clipping, but even when PICA aneurysms were removed from the analysis, outcomes for the posterior circulation aneurysms still favored coiling.
Conclusions Although BRAT was statistically underpowered to detect small differences, these results suggest little difference in outcome between the 2 treatments for anterior circulation aneurysms. This was not the case for the posterior circulation aneurysms, where coil embolization appeared to provide a sustained advantage over clipping. Aneurysm obliteration rates in BRAT were significantly lower and retreatment rates significantly higher in the patients undergoing coiling than in those undergoing clipping. However, despite the fact that retreatment rates were higher after coiling, no recurrent hemorrhages were known to have occurred in patients undergoing coiling in BRAT who were followed up for 6 years. Sufficient questions remain about the relative benefits of the 2 treatment modalities to warrant further welldesigned randomized trials.
J Neurosurg 121:605–612, 2014
This study aimed to investigate morphological predictors of intraprocedural rupture (IPR) during coil embolization of ruptured cerebral aneurysms.
Methods. A retrospective analysis was conducted in 322 consecutive patients with ruptured cerebral aneurysms who were treated with coil embolization over an 8-year period from January 2005 to December 2012. The authors analyzed all available data with emphasis on morphological characteristics of the aneurysm as shown on baseline angiography in relation to IPR. Regarding aneurysm morphology, the authors classified patients according to multilobulation, presence of a daughter sac, and presence of a small basal outpouching (SBO).
Results. The incidence of IPR was 4.8% (16 of 332). In terms of aneurysm configuration, the presence of multilobulation (100.0% [16 of 16] in the IPR group vs 89.2% [282 of 316] in the non-IPR group, p = 0.388) and daughter sac (75.0% [12 of 16] in the IPR group vs 59.2% [187 of 316] in the non-IPR group, p = 0.208) were not significantly associated with IPR. However, SBO, found in 9% (30 of 332) of the study population, was significantly associated with IPR (56.3% [9 of 16] in the IPR group vs 6.7% [21 of 316] in the non-IPR group, OR 18.06, p < 0.0001).
Conclusions. Based on the authors’ data, the more general groups of multilobulation and daughter sac were not significantly associated with IPR, although the more specific subgroup with an SBO was. More confirmation studies on these results are required, but they point to the possibility that SBO (with its possible connection to basal rupture) is an important morphological risk factor for IPR during coiling. In addition, future comparison of coiling and clipping treatment for ruptured aneurysms associated with an SBO seems necessary.
J Neurosurg 116:135–144, 2012.DOI: 10.3171/2011.8.JNS101767
The purpose of this ongoing study is to compare the safety and efficacy of microsurgical clipping and endovascular coil embolization for the treatment of acutely ruptured cerebral aneurysms and to determine if one treatment is superior to the other by examining clinical and angiographic outcomes. The authors examined the null hypothesis that no difference exists between the 2 treatment modalities in the setting of subarachnoid hemorrhage (SAH). The current report is limited to the clinical results at 1 year after treatment.
Methods. The authors screened 725 patients with SAH, resulting in 500 eligible patients who were enrolled prospectively in the study after giving their informed consent. Patients were assigned in an alternating fashion to surgical aneurysm clipping or endovascular coil therapy. Intake evaluations and outcome measurements were collected by nurse practitioners independent of the treating surgeons. Ultimately, 238 patients were assigned to aneurysm clipping and 233 to coil embolization. The 2 treatment groups were well matched. There were no anatomical exclusions. Crossing over was allowed, but primary outcome analysis was based on the initial treatment modality assignment. Posttreatment care was standardized for both groups. Patient outcomes at 1 year were independently assessed using the modified Rankin Scale (mRS). A poor outcome was defined as an mRS score > 2 at 1 year. The primary outcome was based on the assigned group; that is, by intent to treat.
Results. One year after treatment, 403 patients were available for evaluation. Of these, 358 patients had actually undergone treatment. The remainder either died before treatment or had no identifiable source of SAH. A poor outcome (mRS score > 2) was observed in 33.7% of the patients assigned to aneurysm clipping and in 23.2% of the patients assigned to coil embolization (OR 1.68, 95% CI 1.08–2.61; p = 0.02). Of treated patients assigned to the coil group, 124 (62.3%) of the 199 who were eligible for any treatment actually received endovascular coil embolization. Patients who crossed over from coil to clip treatment fared worse than patients assigned to coil embolization, but no worse than patients assigned to clip occlusion. No patient treated by coil embolization suffered a recurrent hemorrhage.
Conclusions. One year after treatment, a policy of intent to treat favoring coil embolization resulted in fewer poor outcomes than clip occlusion. Although most aneurysms assigned to the coil treatment group were treated by coil embolization, a substantial number crossed over to surgical clipping. Although a policy of intent to treat favoring coil embolization resulted in fewer poor outcomes at 1 year, it remains important that high-quality surgical clipping be available as an alternative treatment modality.
J Neurosurg 114:944–953, 2011. DOI: 10.3171/2010.3.JNS081131
The purpose of this paper was to present the safety, efficacy, and clinical/angiographic follow-up results of HyperForm balloon-assisted endosaccular coil occlusion of distal anterior circulation bifurcation aneurysms.
Methods. Over a 7-year period, the authors treated 864 middle cerebral artery, distal anterior cerebral artery bifurcation, and anterior communicating artery aneurysms by means of coil embolization with HyperForm balloon assistance in 800 patients. In 37 aneurysms, 2 HyperForm balloons were used simultaneously for remodeling.
Results. The overall mortality rate was 7.1%, including 1.4% procedural mortality. Various neurological deficits were present at discharge in 8.9% of the patients, and 4.4% had permanent disabling morbidity 6 months posttreatment (modified Rankin Scale score ≥ 2). Thromboembolic complications developed during the treatment of 15 aneurysms (1.7%) causing morbidity or mortality in 10 cases (1.3%). There were 14 intraoperative perforations (1.6%). In all 14 cases, the HyperForm balloon saved patients from severe bleeding. The perforation led to morbidity or mortality in 3 cases (0.4%); there were no negative consequences in 11. There were 726 patients with 757 aneurysms (87.6%) available for follow-up. Control angiograms were obtained at 6 months in 386 patients, at 1 year in 267, and at 2 years in 104, revealing an 82% complete obliteration rate according to the most recent follow-up angiograms.
Conclusions. The satisfactory results obtained in this experience demonstrate that HyperForm balloon remodeling provides strong benefits for the endovascular management of middle cerebral, anterior cerebral, and anterior communicating artery aneurysms without increasing the risk of treatment. Not only does this technique allow for the safe treatment of these aneurysms, but it also expands the indications of endovascular treatment to include aneurysms that otherwise cannot be treated with simple coil embolization.
Neurosurgery 66:1128-1133, 2010 DOI: 10.1227/01.NEU.0000367998.33743.D6
To evaluate clinical presentation, safety, techniques, clinical and angiographic outcomes, and prognostic factors of coiling for remnant/recurred aneurysm after clipping.
METHODS:Twenty-four consecutive patients (11 men and 13 women; mean age, 52 years) with 24 recurred/remnant aneurysms after clipping underwent coil embolization between September 2000 and December 2008. Clinical presentations of remnant/recurred aneurysms, safety, techniques, clinical and angiographic outcomes, and prognostic factors of coil embolization were retrospectively evaluated.
RESULTS: Twenty-two aneurysms initially presented with subarachnoid hemorrhage and the other two, with mass effect. Eight aneurysms presented with rebleeding and 16 aneurysms were found on follow-up CT angiogram (n = 12) or catheter angiogram (n = 4). The interval between clipping and coiling ranged from 8 days to 114 months (mean, 31 months). Twelve were treated by using single-catheter, 6 by stent-assisted, 4 by multicatheter, 1 by both balloon- and catheter-assisted, and 1 by balloon-in-stent technique. Immediate postembolization angiogram revealed complete obliteration (n = 19) or residual neck (n = 5). Procedure-related permanent morbidity and mortality rates were 4.2% (1 of 24) and 0%, respectively. There was no rebleeding during clinical follow-up for 3 to 82 months (mean, 24 months). Presentation with rupture after clipping was the only significant predictor of poor outcome (P < .05).
CONCLUSION: Coiling seems to be a safe and effective retreatment option for remnant/ recurred aneurysm after clipping. Presentation with rupture after clipping is the only predictor of poor outcome. For routine/regular follow-up after clipping, CT angiography may be the imaging modality advisable for detection of remnant/recurred aneurysm.