Return to Community Mental Health Centers after the Pandemic: A Qualitative Study on Turkish Patients' Subjective Experiences.

BACKGROUND: Community mental health centers (CMHCs) are important institutions for individuals with chronic mental illness. During the COVID-19 period, patients with mental health could not optimally access care in CMHCs. AIM: To explore the experiences of patients using a CMHC after its closure due to the COVID-19 pandemic. PATIENTS AND METHODS: This was a descriptive qualitative study that included 16 patients with mental disorders who regularly used CMHCs during the pre-pandemic period. Their data were collected between March 2022 and August 2022 using face-to-face, in-depth semi-structured interviews. All interviews were recorded and the content analysis method was used to analyze the data. RESULTS: The age range of the 16 study participants was 29-53 years with a mean age of 40.8 ± 6.5 years. Nine (56.3%) participants were men, and 7 (43.7%) were women. Ten (62.5%) participants had schizophrenia, whereas 6 (37.5%) had bipolar disorder. According to content analysis, the five main themes that emerged based on the statements of participants were the effects of change, difficulties experienced, support needs, coping experiences, and suggestions. The results showed that although patients using CMHCs are struggling with the adverse consequences of the pandemic process, they also have difficulty managing their diseases and daily life due to their inability to access psychosocial services in the CMHCs. CONCLUSION: The patients reported their negative experiences and need for support during the pandemic. The study highlights the need to adequately accommodate mental health services delivery during future pandemics that may impose movement restrictions.

Can the monocyte-to-HDL ratio be used as an inflammation marker in patients with fibromyalgia syndrome?

Background and Aim: The monocyte-to-high-density lipoprotein (HDL) ratio (MHR) may be used as a marker of inflammation and oxidative stress. This study aimed to evaluate the use of MHR and platelet markers in patients with fibromyalgia syndrome (FMS) and demonstrate MHR's relationship with inflammation, the Fibromyalgia Impact Questionnaire (FIQ), and quality of life. Materials and Methods: Ninety FMS patients and 90 healthy controls, whose clinical and laboratory evaluations were performed simultaneously, were included in the study. The monocyte, platelet, HDL, MHR, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), mean platelet volume (MPV), and platelet distribution width (PDW) values of all patients were evaluated. The quality of life of the participants was assessed using the FIQ and their general health using the health assessment questionnaire (HAQ). Results: Age, body mass index (BMI), and marital status distribution were similar in both groups. The FMS patients had a mean disease duration of 11.29 ± 2.62 months. The median monocyte, platelet, MPV, visual analog scale (VAS), FIQ, and HAQ values and the mean MHR of the FMS patients were significantly higher than the control group, while the mean HDL level was significantly lower (P < 0.05). There was a weak negative correlation between the MPV and HAQ score and the PDW and HAQ score (rs = -0.225, P = 0.042 and rs = -0.249, P = 0.024, respectively), whereas no correlation was detected between the MHR and the FIQ and HAQ scores in FMS patients. According to the receiver operating characteristic curve analysis, MHR had prediction of FMS (P = 0.002; sensitivity = 0.63, specificity = 0.50, cut-off point ≥8.4). Conclusions: Our results suggest that the monocyte, platelet, HDL, MHR, and MPV parameters can be used in the evaluation of inflammation in FMS patients.

Protective effect of benfotiamine on methotrexate induced gastric damage in rats.

Methotrexate (MTX) is widely used for treating cancers and inflammatory diseases; it is a potential anti-metabolite and folate antagonist. We investigated potential protective effects of benfotiamine on MTX damage. We used a rat model of MTX induced gastric injury to assess changes in gastric histopathology, oxidative stress and visfatin levels due to MTX treatment. Rats were divided into four groups: an untreated control group, an MTX group treated with a single dose of MTX, a benfotiamine group treated with benfotiamine daily for two weeks, and a benfotiamine + MTX group treated with a single dose of MTX followed by benfotiamine daily for two weeks. Total tissue antioxidant status (TAS), total oxidant status (TOS) and visfatin levels were measured at the end of the experiment. At the end of the experiment, we investigated both visfatin expression and the histopathology of gastric tissues. The mean visfatin level was lower in the MTX group than in the benfotiamine group. The mean tissue TOS levels were higher in MTX group than in the control, benfotiamine or benfotiamine + MTX groups. Significant gastric gland dilation, and erosion and loss of mucosa were found on the gastric surface in the MTX group compared to the control group. The dilation, erosion and mucosal loss were decreased significantly in the benfotiamine + MTX group compared to the MTX group. Compared to the control group, visfatin immunoreactivity was reduced significantly in the MTX group. Decreased visfatin levels appear to play a role in the mechanism of gastric damage. Benfotiamine may be useful for preventing MTX induced gastric injuries.

Artemisinin attenuates doxorubicin induced cardiotoxicity and hepatotoxicity in rats.

We investigated the effects of artemisinin on doxorubicin (Dox) induced heart and liver pathology in rats. We divided 49 male rats into seven groups: group 1 was the untreated control. Dox was administered intraperitoneally to groups 2, 3 and 4 on day 1. Artemisinin was administered by gavage to groups 3 and 6 at a dose of 7 mg/kg, and to groups 4 and 7 at a dose of 35 mg/kg for 14 days. Group 5 was given only 0.9% NaCl orally for 14 days. At the end of the study, heart and liver samples were collected for histopathology and immunohistochemistry. Hyperemia and slight hemorrhages were observed in both livers and hearts of rats treated with Dox only. Significant increases in caspase-3, TNF-α, iNOS and NF-κB expression were observed in the myocardial cells and hepatocytes of group 2. Significant reductions in caspase-3, TNF-α, iNOS and NF-κB expression were observed in groups 3 and 4 following artemisinin treatment compared to group 2. Artemisinin may exert protective effects against Dox induced cardiotoxicity and hepatotoxicity in rats.

Does Increasing Packing Density Using Larger Caliber Coils Improve Angiographic Results of Embolization of Intracranial Aneurysms at 1 Year: A Randomized Trial.

BACKGROUND AND PURPOSE: The impact of increased aneurysm packing density on angiographic outcomes has not been studied in a randomized trial. We sought to determine the potential for larger caliber coils to achieve higher packing densities and to improve the angiographic results of embolization of intracranial aneurysms at 1 year. MATERIALS AND METHODS: Does Embolization with Larger Coils Lead to Better Treatment of Aneurysms (DELTA) was an investigator-initiated multicenter prospective, parallel, randomized, controlled clinical trial. Patients had 4- to 12-mm unruptured aneurysms. Treatment allocation to either 15- (experimental) or 10-caliber coils (control group) was randomized 1:1 using a Web-based platform. The primary efficacy outcome was a major recurrence or a residual aneurysm at follow-up angiography at 12 ± 2 months adjudicated by an independent core lab blinded to the treatment allocation. Secondary outcomes included indices of treatment success and standard safety outcomes. Recruitment of 564 patients was judged necessary to show a decrease in poor outcomes from 33% to 20% with 15-caliber coils. RESULTS: Funding was interrupted and the trial was stopped after 210 patients were recruited between November 2013 and June 2017. On an intent-to-treat analysis, the primary outcome was reached in 37 patients allocated to 15-caliber coils and 36 patients allocated to 10-caliber coils (OR = 0.931; 95% CI, 0.528-1.644; P = .885). Safety and other clinical outcomes were similar. The 15-caliber coil group had a higher mean packing density (37.0% versus 26.9%, P = .0001). Packing density had no effect on the primary outcome when adjusted for initial angiographic results (OR = 1.001; 95% CI, 0.981-1.022; P = .879). CONCLUSIONS: Coiling of aneurysms randomized to 15-caliber coils achieved higher packing densities compared with 10-caliber coils, but this had no impact on the angiographic outcomes at 1 year, which were primarily driven by aneurysm size and initial angiographic results.

An Update on the Adjunctive Neurovascular Support of Wide-Neck Aneurysm Embolization and Reconstruction Trial: 1-Year Safety and Angiographic Results.

BACKGROUND AND PURPOSE: The safety and efficacy of the PulseRider for the treatment of wide-neck, bifurcation aneurysms at the basilar and carotid terminus locations were studied in a prospective trial, the Adjunctive Neurovascular Support of Wide-Neck Aneurysm Embolization and Reconstruction (ANSWER) trial, reporting on initial 6-month angiographic and clinical results. This report provides insight into the longer term durability and safety with 12-month data. MATERIALS AND METHODS: Aneurysms treated with the PulseRider among enrolled sites were prospectively studied. Updated 12-month data on clinical and imaging end points are included. RESULTS: Thirty-four patients were enrolled (29 women, 5 men) with a mean age of 60.9 years. The mean aneurysm height ranged from 2.4 to 15.9 mm with a mean neck size of 5.2 mm (range, 2.3-11.6 mm). At 1 year, there were no device migrations or symptomatic in-stent stenoses. Raymond-Roy I occlusion was achieved in 53% of cases at the time of treatment and progressed to 61% and 67% at 6 and 12 months, respectively. Adequate occlusion (Raymond-Roy I/II) progressed from 88% at 6 months to 90% at 12 months. No recanalizations were observed. There was 1 delayed ischemic event. Good outcome (mRS 0-2) was achieved in 90% of patients. CONCLUSIONS: The updated 1-year results from the ANSWER trial demonstrate aneurysm stability and an acceptable safety profile for aneurysms treated at the basilar apex and carotid terminus. Prospective data from a larger set of aneurysms treated at other locations are required to assess how treatment with PulseRider compares with alternatives for treating wide-neck bifurcation aneurysms.

Hydrogel versus Bare Platinum Coils in Patients with Large or Recurrent Aneurysms Prone to Recurrence after Endovascular Treatment: A Randomized Controlled Trial.

BACKGROUND AND PURPOSE: Some patients are at high risk of aneurysm recurrence after endovascular treatment: patients with large aneurysms (Patients Prone to Recurrence After Endovascular Treatment PRET-1) or with aneurysms that have previously recurred after coiling (PRET-2). We aimed to establish whether the use of hydrogel coils improved efficacy outcomes compared with bare platinum coils. MATERIALS AND METHODS: PRET was an investigator-led, pragmatic, multicenter, parallel, randomized (1:1) trial. Randomized allocation was performed separately for patients in PRET-1 and PRET-2, by using a Web-based platform ensuring concealed allocation. The primary outcome was a composite of a residual/recurrent aneurysm, adjudicated by a blinded core laboratory, or retreatment, intracranial bleeding, or mass effect during the 18-month follow-up. Secondary outcomes included adverse events, mortality, and morbidity (mRS > 2). The hypothesis was that hydrogel would decrease the primary outcome from 50% to 30% at 18 months, necessitating 125 patients per group (500 for PRET-1 and PRET-2). RESULTS: The trial was stopped once 250 patients in PRET-1 and 197 in PRET-2 had been recruited because of slow accrual. A poor primary outcome occurred in 44.4% (95% CI, 35.5%-53.2%) of those in PRET-1 allocated to platinum compared with 52.5% (95% CI, 43.4%-61.6%) of patients allocated to hydrogel (OR, 1.387; 95% CI, 0.838-2.295; P = .20) and in 49.0% (95% CI, 38.8%-59.1%) in PRET-2 allocated to platinum compared with 42.1% (95% CI, 32.0%-52.2%) allocated to hydrogel (OR, 0.959; 95% CI, 0.428-1.342; P = .34). Adverse events and morbidity were similar. There were 3.6% deaths (1.4% platinum, 5.9% hydrogel; P = .011). CONCLUSIONS: Coiling of large and recurrent aneurysms is safe but often poorly effective according to angiographic results. Hydrogel coiling was not shown to be better than platinum.

Analysis of prehospital care and emergency room treatment of patients with acute traumatic spinal cord injury: a retrospective cohort study on the implementation of current guidelines.

STUDY DESIGN: Retrospective cohort study. OBJECTIVES: The aims of the current study were (i) to analyze prehospital and emergency room treatment of patients with acute traumatic spinal cord injury (SCI) and (ii) to analyze whether recommendations given by the current guidelines are implemented. SETTING: German level I trauma center. METHODS: All patients suffering from traumatic SCI who were initially surgically treated in our hospital in the period from January 2008 to December 2013 were included in this study. Available data documented as a standard procedure in our trauma center included patient's demographic and medical information, as well as trauma mechanisms, cause of injury, neurological diagnosis and detailed clinical information about prehospital and early hospital management procedures. Retrospectively, statistical analysis was performed to describe spinal immobilization rates, transportation times and methylprednisolone administration. RESULTS: A total of 133 patients (mean age: 50.5±21.2 years) met the inclusion criteria. Immobilization was performed on 69.9% of the patients with traumatic SCI. From 60 patients suffering from cervical traumatic SCI, 47 patients had a cervical collar. Full immobilization was only performed in 34 of these 60 patients. Mean time from accident site to emergency room was 61.3±28.7 min. In 25 out of the 133 patients included in the current study, early surgery was not possible because of insufficient circulation and/or increased intracranial pressure. A total of 108 patients could be prepared for early surgery within 322.8±254.1 min after the accident. CONCLUSION: The current study shows that recommendations of the current literature and guidelines are mostly followed.

Irisin immunostaining characteristics of breast and ovarian cancer cells.

To determine expression pattern of irisin in tissues obtained from human ovarian cancer, breast cancer, and cervix cancer. Tissue samples obtained from subjects with breast cancer, ovarian cancer cervix cancer, simple endometrial hyperplasia, complex atypical endometrial hyperplasia. At least five sections from each subject were immunohistochemically stained with irisin antibody, and H-score method was used to evaluate irisin intensity. Tissues obtained from healthy breast tissues, proliferative phase endometrium adenomyosis and benign ovarian tumors were accepted as control. Irisin activity was not detected in control breast tissues significantly increased irisin staining was detected in invasive lobular, intraductal papillary, invasive ductal, invasive papillary, and mucinous carcinomas compared to control tissues. Also, significantly increased irisin immunoreactivity was detected in both ovarian endometriosis and mucinous carcinomas compared to benign tumors. However irisin staining was not observed at the papillary carcinoma of the ovary while sections obtained from simple and complex atypical endometrial hyperplasia, and cervix carcinoma demonstrated irisin immunoreactivity. Increased irisin immunoreactivity in tissues obtained from breast, ovary, cervix carcinomas, and endometrial hyperplasia suggest critical role of this peptide during carcinogenesis.

Geographic Differences in Endovascular Treatment and Retreatment of Cerebral Aneurysms.

BACKGROUND AND PURPOSE: Comparing outcomes between endovascular aneurysm coiling trials can be difficult because of heterogeneity in patients and end points. We sought to understand the impact of geography on aneurysm retreatment in patients enrolled in the Matrix and Platinum Science Trial. MATERIALS AND METHODS: Post hoc analysis was performed on data from the Matrix and Platinum Science trial. Patients were stratified as either North American or international. Baseline patient demographics, comorbidities, aneurysm characteristics, procedural complications, and clinical and angiographic outcomes were compared. RESULTS: We evaluated 407 patients from 28 North American sites and 219 patients from 15 international sites. Patient demographics differed significantly between North American and international sites. Aneurysms were well occluded postprocedure more often at international than North American sites (P < .001). Stents were used significantly more often at North American sites (32.7% [133 of 407]) compared with international sites (10.0% [22 of 219]; P < .001). At 455 days, there was no difference in the proportion of patients alive and free of disability (P = .56) or with residual aneurysm filling (P = .10). Ruptured aneurysms were significantly more likely to have been retreated at North American sites within the first year (P < .001) and at 2 years (P < .001). Among all patients for whom the treating physician believed there to be Raymond 3 aneurysm filling at follow-up, absolute rates of retreatment at international and North American sites were similar by 2-year follow-up. CONCLUSIONS: Data from the Matrix and Platinum Science Trial demonstrate that aneurysm retreatment occurs with different frequency and at different times in different regions of the world. This trend has critical value when interpreting trials reporting short-term outcomes, especially when judgment-based metrics such as retreatment are primary end points that may or may not take place within the defined study follow-up period. Though these variations can be controlled for and balanced within a given randomized trial, such differences in practice patterns must be accounted for in any attempt to compare outcomes between different trials. Despite these differences, endovascular-treated intracranial aneurysms around the world have similar clinical outcomes.

Time-varying signal analysis to detect high-altitude periodic breathing in climbers ascending to extreme altitude.

This work investigates the performance of cardiorespiratory analysis detecting periodic breathing (PB) in chest wall recordings in mountaineers climbing to extreme altitude. The breathing patterns of 34 mountaineers were monitored unobtrusively by inductance plethysmography, ECG and pulse oximetry using a portable recorder during climbs at altitudes between 4497 and 7546 m on Mt. Muztagh Ata. The minute ventilation (VE) and heart rate (HR) signals were studied, to identify visually scored PB, applying time-varying spectral, coherence and entropy analysis. In 411 climbing periods, 30-120 min in duration, high values of mean power (MP(VE)) and slope (MSlope(VE)) of the modulation frequency band of VE, accurately identified PB, with an area under the ROC curve of 88 and 89%, respectively. Prolonged stay at altitude was associated with an increase in PB. During PB episodes, higher peak power of ventilatory (MP(VE)) and cardiac (MP(LF)(HR) ) oscillations and cardiorespiratory coherence (MP(LF)(Coher)), but reduced ventilation entropy (SampEn(VE)), was observed. Therefore, the characterization of cardiorespiratory dynamics by the analysis of VE and HR signals accurately identifies PB and effects of altitude acclimatization, providing promising tools for investigating physiologic effects of environmental exposures and diseases.

Diffusion-Weighted MR Imaging Findings of Cortical Vein Thrombosis at 3 T.

PURPOSE: Diagnosis of cortical vein thrombosis (CVT) on the basis of clot hyperintensity on diffusion-weighted imaging (DWI) has been reported as limited. Our aim was to evaluate different DWI findings of CVT either in isolated form or in combination with sinus thrombosis. METHODS: In this review-board-approved study, patients with the diagnosis of CVT on magnetic resonance venography (MRV) between 2004 and 2011 were evaluated, and 13 patients with 26 CVT (3 isolated and 23 combined CVT) sites were recruited. The evaluated DWI findings were as follows: (1) the hyperintense clot signal (CS) itself, and (2) clot susceptibility signal (CSS) that appears next to the CVT. Two blinded radiologists evaluated the data. Kappa (κ) statistics was applied for interobserver agreement. RESULTS: Both readers reported CS within the vascular clot itself in 6 of 26 (23%) CVT sites on DWI. CSS was reported in 16 of 26 (61.5%) CVT sites by reader 1, and in 14 of 26 (54%) of the CVT sites by reader 2. At four CVT sites with thrombosed veins on MRV, both readers reported no DWI findings. When both CS and CSS were evaluated together, reader 1 reported a positive DWI finding in 22 of 26 (84%) of the CVT sites, and reader 2 reported in 20 of 26 (79%) of the sites. κ Statistics showed a very good agreement (κ: 0.87). CONCLUSIONS: Besides the hyperintense CS, with additional evaluation of the presence of CSS, DWI can provide an additional clue in CVT patients and may suggest its diagnosis, which is important in clinically unsuspected patients.

Intrathyroidal tumors presenting with extranodal extension: what are we missing?

Extranodal extension (ENE) is an indicator of poor prognosis in well-differentiated thyroid cancer (WDTC). We have demonstrated that extrathyroidal extension (ETE) predicts ENE in patients with positive lymph nodes, indicating concordance between primary tumor and lymph node biology. In an effort to determine if there were other histologic features of the primary tumors that indicated an aggressive biology, we examined a subset of patients with intrathyroidal (T1/T2) disease whose lymph nodes had ENE. A review was conducted from January 2004 to March 2013. The histologic features of ETE-negative/ENE-positive tumors (group A, 12 cases) were compared with a random sample of ETE-negative/ENE-negative node-positive patients (group B, 27 cases). Cases were reviewed for size, capsule presence, infiltration, sclerosis, lymphocytic thyroiditis (LT), psammoma bodies, lymphovascular invasion (LVI), perineural invasion (PNI), architecture/cytomorphology, and focality. Size was compared using the Mann-Whitney test, while the remaining features were compared using a Fischer exact test. The breakdown of pathologic features of groups A/B were as follows: 2.28 cm/1.46 cm mean tumor size, 90 %/67 % unencapsulated, 100 %/89 % infiltrative, 100 %/89 % sclerotic, 60 %/52 % LT, 30 %/59 % positive psammoma bodies, 0 %/11 % LVI, 0 %/4 % PNI, 90 %/96 % classic architecture, 50 %/44 % multifocal. Neither size (p = 0.072) nor the other nine histologic features examined reached statistical significance. None of the histologic features appeared to significantly predict ENE. Further examination of intrathyroidal tumors at a molecular level is necessary to determine if there are any identifiable features of intrathyroidal tumors that predict ENE and thus a more aggressive phenotype.

Patients prone to recurrence after endovascular treatment: periprocedural results of the PRET randomized trial on large and recurrent aneurysms.

BACKGROUND AND PURPOSE: Some patients with large or recurrent aneurysms may be at increased risk of recurrence postcoiling. The Patients Prone to Recurrence after Endovascular Treatment (PRET) trial was designed to assess whether hydrogel coils were superior to platinum coils in these high-risk patients. This article reports periprocedural safety and operator-assessed angiographic results from the PRET trial. MATERIALS AND METHODS: PRET was a pragmatic, multicenter, randomized controlled trial. Patients had ≥10-mm aneurysms (PRET-1) or a major recurrence after coiling of an aneurysm of any size (PRET-2). Patients were randomly allocated to hydrogel or control arms (any platinum coil) by using concealed allocation with minimization. Assist devices could be used as clinically required. Aneurysms could be unruptured or recently ruptured. Analyses were on an intent-to-treat basis. RESULTS: Four hundred forty-seven patients were recruited (250 PRET-1; 197 PRET-2). Aneurysms were recently ruptured in 29% of PRET-1 and 4% of PRET-2 patients. Aneurysms were ≥10 mm in all PRET-1 and in 50% of PRET-2 patients. They were wide-neck (≥4 mm) in 70% and in the posterior circulation in 24% of patients. Stents were used in 28% of patients (35% in PRET-2). Coiling was successful in 98%. Adverse events occurred in 28 patients with hydrogel and 23 with platinum coils. Mortality (n=2, unrelated to treatment) and morbidity (defined as mRS>2 at 1 month) occurred in 25 patients (5.6%; 12 hydrogel, 13 platinum), related to treatment in 10 (4 hydrogel; 6 platinum) (or 2.3% of 444 treated patients). No difference was seen between hydrogel and platinum for any of the indices used to assess safety up to at least 30 days after treatment. At 1 month, 95% of patients were home with a good outcome (mRS≤2 or unchanged). Operator-assessed angiographic outcomes were satisfactory (complete occlusion or residual neck) in 339 of 447 or 76.4% of patients, with no significant difference between groups. CONCLUSIONS: Endovascular treatment of large and recurrent aneurysms can be performed safely with platinum or hydrogel coils.

Flow diversion versus traditional endovascular coiling therapy: design of the prospective LARGE aneurysm randomized trial.

BACKGROUND AND PURPOSE: The goal of aneurysm treatment is occlusion of an aneurysm without morbidity or mortality. Using well-established, traditional endovascular techniques, this is generally achievable with a high level of safety and efficacy. These techniques involve either constructive treatment of the aneurysm (coils with or without an intravascular stent) or deconstruction (coil occlusion) of the aneurysm and the parent artery. While established as safe and efficacious, the constructive treatment of large and giant aneurysms with coils has typically been associated with relatively lower rates of complete occlusion and higher rates of recurrence. Parent artery deconstruction, though immediately efficacious in achieving complete and durable occlusion, does require occlusion of a major intracranial blood vessel and is associated with risk of stroke. MATERIALS AND METHODS: Flow diversion represents a new technology that can be used to constructively treat large and giant aneurysms. Once excluded successfully, the vessel reconstruction and aneurysm occlusion appears durable. The ability to definitively reconstruct cerebral blood vessels is an attractive approach to these large and giant complex aneurysms and allows the treatment of some aneurysms which were previously not amenable to other therapies. By comparison, conventional coiling techniques have traditionally been used for endovascular treatment of large aneurysms. Large and giant aneurysms that are amenable to either flow diversion or traditional endovascular treatment will be randomized to either therapy with FDA (or appropriate regulatory body) approved devices. RESULTS: The trial is currently enrolling and results of the data are pending the completion of enrollment and follow-up. CONCLUSIONS: This paper details the trial design of the LARGE trial, a blinded, prospective randomized trial of large anterior circulation aneurysms amenable to either traditional endovascular treatments using coils or reconstruction with flow diverters.

Bioactive versus bare platinum coils in the treatment of intracranial aneurysms: the MAPS (Matrix and Platinum Science) trial.

BACKGROUND AND PURPOSE: The ability of polymer-modified coils to promote stable aneurysm occlusion after endovascular treatment is not well-documented. Angiographic aneurysm recurrence is widely used as a surrogate for treatment failure, but studies documenting the correlation of angiographic recurrence with clinical failure are limited. This trial compares the effectiveness of Matrix(2) polyglycolic/polylactic acid biopolymer-modified coils with bare metal coils and correlates the angiographic findings with clinical failure (ie, target aneurysm recurrence), a composite end point that includes any incident of posttreatment aneurysm rupture, retreatment, or unexplained death. MATERIALS AND METHODS: This was a multicenter randomized noninferiority trial with blinded end point adjudication. We enrolled 626 patients, divided between Matrix(2) and bare metal coil groups. The primary outcome was target aneurysm recurrence at 12 ± 3 months. RESULTS: At 455 days, at least 1 target aneurysm recurrence event had occurred in 14.6% of patients treated with bare metal coils and 13.3% of Matrix(2) (P = .76, log-rank test) patients; 92.8% of target aneurysm recurrence events were re-interventions for aneurysms that had not bled after treatment, and 5.8% of target aneurysm recurrence events resulted from hemorrhage or rehemorrhage, with or without retreatment. Symptomatic re-intervention occurred in only 4 (0.6%) patients. At 455 days, 95.8% of patients with unruptured aneurysms and 90.4% of those with ruptured aneurysms were independent (mRS ≤ 2). Target aneurysm recurrence was associated with incomplete initial angiographic aneurysm obliteration, presentation with rupture, and a larger aneurysmal dome and neck size. CONCLUSIONS: Tested Matrix(2) coils were not inferior to bare metal coils. Endovascular coiling of intracranial aneurysms was safe, and the rate of technical success was high. Target aneurysm recurrence is a promising clinical outcome measure that correlates well with established angiographic measurements.

Stent-assisted coiling versus coiling alone in unruptured intracranial aneurysms in the matrix and platinum science trial: safety, efficacy, and mid-term outcomes.

BACKGROUND AND PURPOSE: Stent-assisted coiling may result in less aneurysm recanalization but more complications than coiling alone. We evaluated outcomes of coiling with and without stents in the multicenter Matrix and Platinum Science Trial. MATERIALS AND METHODS: All patients in the Matrix and Platinum Science Trial with unruptured intracranial aneurysms treated per protocol were included. Baseline patient and aneurysm characteristics, procedural details, neurologic outcomes, angiographic outcomes, and safety data were analyzed. RESULTS: Overall, 137 of 361 (38%) patients were treated with a stent. Stent-coiled aneurysms had wider necks (≥4 mm in 62% with stents versus 33% without, P < .0001) and lower dome-to-neck ratios (1.3 versus 1.8, P < .0001). Periprocedural serious adverse events occurred infrequently in those treated with and without stents (6.6% versus 4.5%, P = .39). At 1 year, total significant adverse events, mortality, and worsening of mRS were similar in treatment groups, but ischemic strokes were more common in stent-coiled patients than in coiled patients (8.8% versus 2.2%, P = .005). However, multivariate analysis confirmed that at 2 years after treatment, prior cerebrovascular accident (OR, 4.7; P = .0089) and aneurysm neck width ≥4 mm (OR, 4.5; P = .02) were the only independent predictors of ischemic stroke. Stent use was not an independent predictor of ischemic stroke at 2 years (OR, 1.1; P = .94). Stent use did not predict target aneurysm recurrence at 2 years, but aneurysm dome size ≥10 mm (OR, 9.94; P < .0001) did predict target aneurysm recurrence. CONCLUSIONS: Stent-coiling had similar outcomes as coiling despite stented aneurysms having more difficult morphology than coiled aneurysms. Increased ischemic events in stent-coiled aneurysms were attributable to baseline risk factors and aneurysm morphology.