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 ◽  
...  

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)

2020 ◽  
Vol 132 (3) ◽  
pp. 771-776 ◽  
Author(s):  
Robert F. Spetzler ◽  
Cameron G. McDougall ◽  
Joseph M. Zabramski ◽  
Felipe C. Albuquerque ◽  
Nancy K. Hills ◽  
...  

OBJECTIVEThe 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.METHODSIn 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.RESULTSThere 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.CONCLUSIONSThere 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)


Neurosurgery ◽  
2018 ◽  
Vol 85 (5) ◽  
pp. 622-631 ◽  
Author(s):  
Justin R Mascitelli ◽  
Michael T Lawton ◽  
Benjamin K Hendricks ◽  
Peter Nakaji ◽  
Joseph M Zabramski ◽  
...  

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


BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e042246
Author(s):  
Sanjoy K Paul ◽  
Olga Montvida ◽  
Jennie H Best ◽  
Sara Gale ◽  
Attila Pethö-Schramm ◽  
...  

ObjectiveTo explore possible associations of treatment with biological disease-modifying antirheumatic drugs (bDMARDs), including T-cell-based and interleukin-6 inhibition (IL-6i)-based therapies, and the risk for type 2 diabetes mellitus (T2DM) in patients with rheumatoid arthritis (RA).Study design, setting and participantsFive treatment groups were selected from a United States Electronic Medical Records database of 283 756 patients with RA (mean follow-up, 5 years): never received bDMARD (No bDMARD, n=125 337), tumour necrosis factor inhibitors (TNFi, n=34 873), IL-6i (n=1884), T-cell inhibitors (n=5935) and IL-6i+T cell inhibitor abatacept (n=1213). Probability and risk for T2DM were estimated with adjustment for relevant confounders.ResultsIn the cohort of 169 242 patients with a mean 4.5 years of follow-up and a mean 641 200 person years of follow-up, the adjusted probability of developing T2DM was significantly lower in the IL-6i (probability, 1%; 95% CI 0.6 to 2.0), T-cell inhibitor (probability, 3%; 95% CI 2.3 to 3.3) and IL-6i+T cell inhibitor (probability, 2%; 95% CI 0.1 to 2.9) groups than in the No bDMARD (probability, 5%; 95% CI 4.6 to 4.9) and TNFi (probability, 4%; 95% CI 3.7 to 4.7) groups. Compared with No bDMARD, the IL-6i and IL-6i+T cell inhibitor groups had 37% (95% CI of HR 0.42 to 0.96) and 34% (95% CI of HR 0.46 to 0.93) significantly lower risk for T2DM, respectively; there was no significant difference in risk in the TNFi (HR 0.99; 95% CI 0.93 to 1.06) and T-cell inhibitor (HR 0.96; 95% CI 0.82 to 1.12) groups.ConclusionsTreatment with IL-6i, with or without T-cell inhibitors, was associated with reduced risk for T2DM compared with TNFi or No bDMARDs; a less pronounced association was observed for the T-cell inhibitor abatacept.


2021 ◽  
pp. 112070002110057
Author(s):  
Niels H Bech ◽  
Inger N Sierevelt ◽  
Sheryl de Waard ◽  
Boudijn S H Joling ◽  
Gino M M J Kerkhoffs ◽  
...  

Background: Hip capsular management after hip arthroscopy remains a topic of debate. Most available current literature is of poor quality and are retrospective or cohort studies. As of today, no clear consensus exists on capsular management after hip arthroscopy. Purpose: To evaluate the effect of routine capsular closure versus unrepaired capsulotomy after interportal capsulotomy measured with NRS pain and the Copenhagen Hip and Groin Outcome Score (HAGOS). Materials and methods: All eligible patients with femoroacetabular impingement who opt for hip arthroscopy ( n = 116) were randomly assigned to one of both treatment groups and were operated by a single surgeon. Postoperative pain was measured with the NRS score weekly the first 12 weeks after surgery. The HAGOS questionnaire was measured at 12 and 52 weeks postoperatively. Results: Baseline characteristics and operation details were comparable between treatment groups. Regarding the NRS pain no significant difference was found between groups at any point the first 12 weeks after surgery ( p = 0.67). Both groups significantly improved after surgery ( p < 0.001). After 3 months follow-up there were no differences between groups for the HAGOS questionnaire except for the domain sport ( p = 0.02) in favour of the control group. After 12 months follow-up there were no differences between both treatment groups on all HAGOS domains ( p  > 0.05). Conclusions: The results of this randomised controlled trial show highest possible evidence that there is no reason for routinely capsular closure after interportal capsulotomy at the end of hip arthroscopy. Trial Registration: This trial was registered at the CCMO Dutch Trial Register: NL55669.048.15.


2007 ◽  
Vol 35 (10) ◽  
pp. 1659-1667 ◽  
Author(s):  
Wolf Petersen ◽  
Robert Welp ◽  
Dieter Rosenbaum

Background Previous studies have shown that eccentric training has a positive effect on chronic Achilles tendinopathy. A new strategy for the treatment of chronic Achilles tendinopathy is the AirHeel brace. Hypothesis AirHeel brace treatment improves the clinical outcome of patients with chronic Achilles tendinopathy. The combination of the AirHeel brace and an eccentric training program has a synergistic effect. Study Design Randomized controlled clinical trial; Level of evidence, 1. Methods One hundred patients were randomly assigned to 1 of 3 treatment groups: (1) eccentric training, (2) AirHeel brace, and (3) combination of eccentric training and AirHeel brace. Patients were evaluated at 6, 12, and 54 weeks after the beginning of the treatment protocol with ultrasonography, visual analog scale (VAS) for pain, American Orthopaedic Foot and Ankle Society (AOFAS) ankle score, and Short Form-36 (SF-36). Results The VAS score for pain, AOFAS score, and SF-36 improved significantly in all 3 groups at all 3 follow-up examinations. At the 3 time points (6 weeks, 12 weeks, and 54 weeks) of follow-up, there was no significant difference between all 3 treatment groups. In all 3 groups, there was no significant difference in tendon thickness after treatment. Conclusions The AirHeel brace is as effective as eccentric training in the treatment of chronic Achilles tendinopathy. There is no synergistic effect when both treatment strategies are combined. Clinical Relevance The AirHeel brace is an alternative treatment option for chronic Achilles tendinopathy.


Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Fengli Li ◽  
Hongfei Sang ◽  
Jiaxing Song ◽  
Zhangbao Guo ◽  
Shuai Liu ◽  
...  

Background and Objective: To report the results of clinical follow-up at 1 year among patients in the BASILAR registry. Design, Setting, and Participants: The BASILAR study was an investigator-initiated prospective registry, which consecutively enrolled stroke patients with acute basilar artery occlusion from 47 comprehensive stroke centers in China between January, 2014, and May, 2019. Patients were divided into conventional treatment or endovascular treatment groups according to the treatment their received. We assessed clinical outcomes 1 year after patients were enrolled in the BASILAR registry. Main Outcomes and Measures: The primary outcome was the score on the modified Rankin scale (range, 0 to 6 points, with higher scores indicating more severe disability) at 1 year assessed as a common odds ratio using ordinal logistic regression shift analysis, adjusted for prespecified prognostic factors. Secondary outcomes included categories scores of the modified Rankin scale at 1 year (0 to 1 [excellent outcome], 0 to 2 [good outcome], and 0 to 3 [favorable outcome]), and death from any cause during the 1-year period after enrollment. Results: Of the 829 patients who were enrolled in the original study, 1-year data for this extended follow-up study were available for 785 patients (94.7%). The distribution of outcomes on the modified Rankin scale favored endovascular treatment over conventional treatment (adjusted common odds ratio, 4.50; 95% confidence interval [CI], 2.81 to 7.29; P < 0.001). There were significant differences between the treatment groups in the percentage of patients who had excellent outcome, good outcome and favorable outcome. The cumulative 1-year mortality rate was 54.6% in the endovascular treatment group and 83.5% in the conventional treatment group (adjusted hazard ratio, 4.36; 95% CI, 2.69 to 7.29; P < 0.001). Conclusions and Relevance: In this extended follow-up study, the beneficial effect of endovascular treatment on functional outcome at 1 year in patients with acute basilar artery occlusion was similar to that reported at 90 days in the original study.


2018 ◽  
Vol 47 ◽  
pp. 07006
Author(s):  
Saryono Saryono ◽  
Hesti Devinta ◽  
Abdul Haris Budi Widodo ◽  
Arif Imam Hidayat

Contaminated water often affects the occurrence of periodontitis in the coastal area. The diabetic hypercholesterolemia-induced periodontitis in Indonesia is very high. The use of coenzyme Q10 to treat this disease has never been investigated yet. Therefore, this study aimedto analyze the effect of coenzyme Q10 on the lipid profile of diabetic hypercholesterolemia-induced periodontitis.Twenty four rats were randomized into 6 groups (G1-G6). The groups (G1-G3) are healthy, negative and positive control group respectively. The treatment groups (G4-G6) are diabetic hypercholesterolemia-induced rats given coenzyme q10 dose of 13,5; 27 and 54 mg/kg respectively. Rats were induced by periodontitis, hypercholesterolemia and diabetes mellitus. Coenzyme Q10 was administered orally using 2 mL gastric tube once a day for 14 days. Lipid profile including triglycerides, HDL, and atherogenic index (IA) was measured enzymatically by the CHOD-PAP method. Data were analyzed by one-way ANOVA test and followed by the Least Significant Difference (LSD) post hoc test.Coenzyme Q10 with a dose of 54 mg/kgis effective in lowering triglyceride, and atherogenic index and increasing HDL level in diabetic hyperlipidemia-induced periodontitis rats model. This research supports the potential effects of coenzyme Q10 supplementation to improve lipid profile in diabetic hypercholesterolemia-induced periodontitis in the coastal area.


2018 ◽  
Vol 12 (5) ◽  
pp. 509-514 ◽  
Author(s):  
M. Troy ◽  
B. Shore ◽  
P. Miller ◽  
S. Mahan ◽  
D. Hedequist ◽  
...  

Purpose To compare two common surgical techniques of epiphysiodesis: drill/curettage epiphysiodesis (PDED) versus cross screw epiphysiodesis (PETS). The hypothesis is that the two techniques have similar efficacy but demonstrate differences in length of hospital stay (LOS), time to return to activity and complication rates. Methods A retrospective review of growing children and adolescents less than 18 years old who required an epiphysiodesis with leg-length discrepancy (LLD) of 2 cm to 6 cm with minimum two years of follow-up was conducted. Characteristics including age at surgery, gender, epiphysiodesis location, side, operative time, LOS and hardware removal were compared across treatment groups. LLD, expected growth remaining (EGR) and bone age were determined preoperatively and at most-recent visit. The correction ratio (change in EGR) was calculated along with a 95% confidence interval (CI) to assess if correction in leg length was achieved. Results A total of 115 patients underwent epiphysiodesis in the femur (53%), tibia (24%) or a combination (24%). The cohort was 47% male, with a mean age of 12.6 years (7.7 to 17.7) at surgery. Median follow-up was 3.7 years (2.0 to 12.7). In all, 23 patients underwent PETS and 92 patients had PDED. Both treatment groups achieved expected LLD correction. There was no significant difference in median operative time, complication rates or LOS. PETS patients returned to activity at a mean 1.4 months (interquartile range (IQR) 0.7 to 2.1) while PDED patients returned at a mean 2.4 months (IQR 1.7 to 3) (p < 0.001). Conclusion Effectiveness in achieving expected correction, LOS and operative time are similar between screw and drill/curettage epiphysiodesis. Patients undergoing PETS demonstrated a faster return to baseline activity than patients with PDED. Level of Evidence: III


2021 ◽  
Vol 8 ◽  
Author(s):  
Kevin F. Barber ◽  
Catherine A. Loughin ◽  
Dominic J. Marino ◽  
Martin Lesser

Objectives: To determine if mycophenolate mofetil reduces the incidence and severity of granulation tissue in-growth in canine tracheal stent patients.Study design: Randomized clinical trial.Animals: 111 dogs from the hospital population.Methods: Client-owned dogs that received an endoluminal self-expanding tracheal stent for canine tracheal collapse between 2014 and 2020 were randomly assigned into one of two treatment groups. Control group medication protocol consisted of prednisone 0.5 mg/kg PO BID/SID/EOD × 30 days, hydrocodone 0.25 mg/kg PO TID × 30 days, and cefovecin 8 mg/kg SQ post-placement. Mycophenolate group medication protocol was identical to the control group medication protocol with the addition of mycophenolate mofetil 10 mg/kg PO BID × 30 days, SID for life. Recheck tracheoscopy was performed at 1, 3, and 6 months post-stent placement. Presence and severity of granulation tissue were determined by tracheoscopy and were recorded as a percentage of tracheal lumen obstruction by blinded evaluators (none present, &lt;25%, &gt;25–50%, and &gt;50%).Results: At none of the three time points was there a statistically significant difference in grade between controls and those receiving mycophenolate (p = 0.467, p = 0.330, and p = 0.410).Conclusions and Clinical Significance: Our results suggest that mycophenolate can be safely given to these patients but do not support that its administration will reduce the incidence and severity of granulation tissue. Although a difference was observed in the severity of granulation tissue between the two groups, loss to follow-up may have influenced conclusions. A larger study would be warranted to further evaluate the effect of mycophenolate on the development of granulation tissue.


2020 ◽  
Vol 22 (12) ◽  
pp. 1176-1183
Author(s):  
Marco Fantinati ◽  
Julien Trnka ◽  
Amélia Signor ◽  
Séverine Dumond ◽  
Géraldine Jourdan ◽  
...  

Objectives The aim of the study was to evaluate the appetite-stimulating effect of gabapentin by comparing it with mirtazapine in healthy cats in the first 8 h after ovariectomy surgery. Methods This double-masked, placebo-controlled, prospective clinical trial included 60 healthy cats presented to the hospital for ovariectomy: 20 received gabapentin, 21 received mirtazapine and 19 received a placebo immediately before and 6 h after surgery. Food was offered at 2, 4, 6 and 8 h post-ovariectomy. After each meal, food intake was measured. Data were analysed using repeated-measure ANOVA and a linear mixed-model analysis. Post-hoc Tukey’s honest significant difference test was performed for multiple comparisons. Results Food intake increased in both treatment groups vs placebo. No statistically significant difference was found between cats treated with gabapentin or mirtazapine. Conclusions and relevance Cats receiving gabapentin ate more than cats in the placebo group. Thirty percent of cats in the gabapentin group covered their resting energy requirements, while none of the cats in the placebo group did. Gabapentin and mirtazapine produced similar effects on food intake.


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