Analysis of Wide-Neck Aneurysms in the Barrow Ruptured Aneurysm Trial

Neurosurgery ◽  
2018 ◽  
Vol 85 (5) ◽  
pp. 622-631 ◽  
Author(s):  
Justin R Mascitelli ◽  
Michael T Lawton ◽  
Benjamin K Hendricks ◽  
Peter Nakaji ◽  
Joseph M Zabramski ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Ruptured Aneurysm ◽  
Width Ratio ◽  
Treatment Groups ◽  
Neck Width ◽  
Retreatment Rate ◽  
Intent To Treat ◽  
Post Hoc ◽  
Wide Neck

Abstract BACKGROUND Ruptured wide-neck aneurysms (WNAs) are difficult to treat and few publications have compared clipping to coiling. OBJECTIVE To determine, using Barrow Ruptured Aneurysm Trial (BRAT) data: (1) How many aneurysms had a wide neck? (2) Did wide-neck status influence treatment? (3) How did clipping compare to coiling for WNAs? METHODS A post hoc analysis was conducted of saccular WNAs in the BRAT. A WNA was defined as maximum neck width ≥ 4 mm or maximum aneurysm dome-diameter–to–neck-width ratio < 2. Both intent-to-treat and as-treated analyses were performed. RESULTS Of the 327 patients analyzed, 177 (54.1%) had a WNA. WNAs were more likely to occur in older patients (P = .03) with worse presenting clinical grade (P = .02), were more likely to arise from the middle cerebral artery, basilar tip, or internal carotid artery other than the junction with the posterior communicating artery (P = .001) and were associated with worse clinical outcomes at all time points (P ≤ .01). WNAs were equally distributed in assigned treatment groups (clip 56.6% vs coil 51.8%; P = .38), but were overrepresented in the actual clipping group (clip 62.4% vs coil 37.6%, P < .001). Most patients (76.7%) in the coil-to-clip crossover group had a WNA. Comparing clipping to coiling, there was no difference in clinical outcomes at any time point in either analysis (P ≥ .33). The aneurysm obliteration rate was lower (P < .001) and the retreatment rate higher (P < .001) in the actual coiling group. CONCLUSION Wide-neck status significantly impacted treatment strategy in the BRAT, favoring clipping. Clipping and coiling of ruptured WNAs resulted in statistically similar long-term clinical outcomes. 10.1093/neuros/nyy439 Video Abstract 10.1093.neuros.nyy439 5850292551001

scholarly journals Analysis of saccular aneurysms in the Barrow Ruptured Aneurysm Trial

2018 ◽  
Vol 128 (1) ◽  
pp. 120-125 ◽  
Author(s):  
Robert F. Spetzler ◽  
Joseph M. Zabramski ◽  
Cameron G. McDougall ◽  
Felipe C. Albuquerque ◽  
Nancy K. Hills ◽  
...  
Keyword(s):  
Ruptured Aneurysm ◽  
Modified Rankin Scale ◽  
Clinical Trial Registration ◽  
Treatment Groups ◽  
Significant Difference ◽  
Initial Hospitalization ◽  
Intent To Treat ◽  
Post Hoc ◽  
Saccular Aneurysms

OBJECTIVEThe 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.METHODSThe 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.RESULTSOf 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).CONCLUSIONSIn 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)

scholarly journals Long-term results of middle cerebral artery aneurysm clipping in the Barrow Ruptured Aneurysm Trial

2019 ◽  
Vol 130 (3) ◽  
pp. 895-901 ◽  
Author(s):  
Michael A. Mooney ◽  
Elias D. Simon ◽  
Scott Brigeman ◽  
Peter Nakaji ◽  
Joseph M. Zabramski ◽  
...  
Keyword(s):  
Endovascular Treatment ◽  
Middle Cerebral Artery ◽  
Clinical Outcomes ◽  
Cerebral Artery ◽  
Long Term Results ◽  
Ruptured Aneurysm ◽  
Microsurgical Clipping ◽  
Mca Aneurysm

OBJECTIVEA direct comparison of endovascular versus microsurgical treatment of ruptured middle cerebral artery (MCA) aneurysms in randomized trials is lacking. As endovascular treatment strategies continue to evolve, the number of reports of endovascular treatment of these lesions is increasing. Herein, the authors report a detailed post hoc analysis of ruptured MCA aneurysms treated by microsurgical clipping from the Barrow Ruptured Aneurysm Trial (BRAT).METHODSThe cases of patients enrolled in the BRAT who underwent microsurgical clipping for a ruptured MCA aneurysm were reviewed. Characteristics of patients and their clinical outcomes and long-term angiographic results were analyzed.RESULTSFifty patients underwent microsurgical clipping of a ruptured MCA aneurysm in the BRAT, including 21 who crossed over from the endovascular treatment arm. Four patients with nonsaccular (e.g., dissecting, fusiform, or blister) aneurysms were excluded, leaving 46 patients for analysis. Most (n = 32; 70%) patients presented with a Hunt and Hess grade II or III subarachnoid hemorrhage, with a high prevalence of intraparenchymal blood (n = 23; 50%), intraventricular blood (n = 21; 46%), or both. At the last follow-up (up to 6 years after treatment), clinical outcomes were good (modified Rankin Scale score 0–2) in 70% (n = 19) of 27 Hunt and Hess grades I–III patients and in 36% (n = 4) of 11 Hunt and Hess grade IV or V patients. There were no instances of rebleeding after the surgical clipping of aneurysms in this series at the time of last clinical follow-up.CONCLUSIONSMicrosurgical clipping of ruptured MCA aneurysms has several advantages over endovascular treatment, including durability over time. The authors report detailed outcome data of patients with ruptured MCA aneurysms who underwent microsurgical clipping as part of a prospective, randomized trial. These results should be used for comparison with future endovascular and surgical series to ensure that the best results are being achieved for patients with ruptured MCA aneurysms.

Efficacy and safety of edoxaban compared with warfarin according to the burden of diseases in patients with atrial fibrillation: insights from the ENGAGE AF-TIMI 48 trial

2019 ◽  
Vol 6 (3) ◽  
pp. 167-175 ◽  
Author(s):  
André M Nicolau ◽  
Ramon Corbalan ◽  
Jose C Nicolau ◽  
Christian T Ruff ◽  
Wolfgang Zierhut ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Outcomes ◽  
Oral Anticoagulants ◽  
Concomitant Disease ◽  
Efficacy And Safety ◽  
Treatment Groups ◽  
Comorbidity Index ◽  
Post Hoc ◽  
The Impact ◽  
Burden Of Diseases

Abstract Aims Non-vitamin K antagonist oral anticoagulants represent a new option for prevention of embolic events in patients with atrial fibrillation (AF). However, little is known about the impact of non-cardiac comorbidities on the efficacy and safety profile of these drugs. Methods and results In a post hoc analysis of the ENGAGE AF-TIMI 48 trial, we analysed 21 105 patients with AF followed for an average of 2.8 years and randomized to either a higher-dose edoxaban regimen (HDER), a lower-dose edoxaban regimen, or warfarin. We used the updated Charlson Comorbidity Index (CCI) to stratify the patients according to the burden of concomitant disease (CCI = 0, 1, 2, 3, and ≥4). The treatment groups were then compared for safety, efficacy, and net clinical outcomes across CCI categories. There were 32.0%, 7.3%, 42.1%, 12.7%, and 6.0% of patients with CCI scores of 0, 1, 2, 3, and ≥4, respectively. A CCI score ≥4 was associated with significantly higher rates of thromboembolic events, bleeding, and death compared to CCI = 0 (P &lt; 0.05 for each). The annualized rates of the primary net clinical outcome (stroke/systemic embolism, major bleeding, or death) for CCI = 0, 1, 2, 3, or ≥4 were 5.9%, 8.7%, 6.6%, 10.3%, and 13.6% (Ptrend &lt; 0.001). There were no significant interactions between treatment with HDER vs. warfarin and efficacy, safety, and net outcomes across the CCI groups (P-interaction &gt; 0.10 for each). Conclusion  Although increasing CCI scores are associated with worse outcomes, the efficacy, safety, and net clinical outcomes of edoxaban vs. warfarin were independent of the degree of comorbidity present.

Angiographic and clinical outcomes of balloon remodeling versus unassisted coil embolization in the ruptured aneurysm cohort of the GEL THE NEC study

2017 ◽  
Vol 10 (5) ◽  
pp. 446-450 ◽  
Author(s):  
Guilherme Dabus ◽  
Waleed Brinjikji ◽  
Arun P Amar ◽  
Josser E Delgado Almandoz ◽  
Orlando M Diaz ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Coil Embolization ◽  
Intracranial Aneurysms ◽  
Ruptured Aneurysm ◽  
Maximum Diameter ◽  
Inclusion Criteria ◽  
Major Morbidity ◽  
Neck Size ◽  
Vertebrobasilar Aneurysms

Background and purposeGEL THE NEC (GTN) was a multicenter prospective registry developed to assess the safety and efficacy of HydroSoft coils in treating intracranial aneurysms. We compared the angiographic and clinical outcomes of aneurysms treated with balloon assisted coil embolization (BACE) versus unassisted coil embolization (CE) in the ruptured aneurysm cohort.Materials and methodsGTN was performed at 27 centers in five countries. Patients aged 21–90 years with a ruptured aneurysm 3–15 mm in size were eligible for enrollment. We analyzed demographics/comorbidities, aneurysm location, and geometry, including maximum diameter, neck size, and dome to neck ratio, immediate and long term angiographic outcomes (graded by an independent core laboratory using the modified Raymond Scale), and procedure related adverse events. Angiographic and clinical outcomes were studied using χ2and t tests.ResultsOf the 599 patients in the GTN, 194 met the inclusion criteria. 84 were treated with BACE and 110 with CE. There were more prior smokers in the BACE group (p=0.01). The BACE group also had more vertebrobasilar aneurysms (p=0.006) and a larger mean neck size (p=0.02). More aneurysms were immediately completely occluded in the BACE group (p=0.02) Procedure- related major morbidity and mortality were no different between the techniques (p=0.4 and p=1, respectively).ConclusionsIn this prospective ruptured aneurysm cohort from the GTN, BACE resulted in greater occlusion rates compared with unassisted CE with similar morbi-mortality.

Long-term clinical and radiographic outcomes of cervical disc replacement with the Prestige disc: results from a prospective randomized controlled clinical trial

2010 ◽  
Vol 13 (3) ◽  
pp. 308-318 ◽  
Author(s):  
J. Kenneth Burkus ◽  
Regis W. Haid ◽  
Vincent C. Traynelis ◽  
Praveen V. Mummaneni
Keyword(s):  
Clinical Outcomes ◽  
Surgical Procedures ◽  
Cervical Disc ◽  
Control Group ◽  
Segmental Motion ◽  
Disc Prosthesis ◽  
Treatment Groups ◽  
The Prestige

Object The purpose of this study was to determine long-term clinical outcomes in patients undergoing anterior cervical surgery in which a cervical disc prosthesis was used to treat single-level degenerative cervical disc disease. Methods In this prospective, nonblinded study, 541 patients at 32 investigational sites were randomly assigned to 1 of 2 treatment groups. The results of the investigational group, in which patients received the Prestige disc prosthesis, were compared with those of the control group, in which patients underwent an instrumented interbody fusion. Data were collected preoperatively, intraoperatively, and at 1.5, 3, 6, 12, 24, 36, and 60 months postoperatively. To date, 271 patients have completed 5 years of clinical follow-up (144 investigational and 127 control patients). Results Significant improvements in Neck Disability Index (NDI) scores, Physical Component Summary scores of the 36-Item Short-Form Health Survey, and neck and arm pain scores were achieved by 1.5 months in both groups and sustained at 5 years. The mean NDI improvements from preoperative scores were 35.4, 36.3, and 38.4 at 24, 36, and 60 months, respectively, in the investigational group. The corresponding mean NDI improvements were 33.9, 31.3, and 34.1 in the control group. The intergroup differences at both 36 and 60 months were significant (p = 0.008 and 0.022, respectively). The overall rates of maintenance or improvement in neurological status in the investigational group were 91.6%, 92.8%, and 95.0%, respectively, at 24, 36, and 60 months compared with 83.6%, 83.2%, and 88.9% in the control group (p = 0.006, 0.004, and 0.051, respectively). The implant effectively maintained angular motion, averaging more than 7.3° at 36 months and 6.5° at 60 months after surgery. No implant migration was observed up to 60 months. There were statistically significant differences between the investigational and control groups with regard to the rate of revision and supplemental fixation surgical procedures performed subsequent to the index procedure. Additional surgical procedures for adjacent-segment disease were observed in both treatment groups. Rates for surgery at adjacent levels trended lower in the investigational group (8 patients [11 surgeries]) compared with those in the control group (13 patients [16 surgeries]), but the differences were not statistically significant (p = 0.376). Some of the second surgeries involved both index and adjacent levels. Conclusions The Prestige disc maintains improved clinical outcomes and segmental motion after implantation at 5-year follow-up.

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