Intrasaccular flow disruption for brain aneurysms: a systematic review of long-term outcomes

2021 ◽  
pp. 1-13

OBJECTIVE The long-term safety and efficacy of intrasaccular flow disruption (IFD) for the treatment of brain aneurysms remain unclear. With accumulating experience and increasing use of IFD devices, recent studies have provided additional data regarding their outcomes. This review summarizes the long-term outcomes of IFD-treated brain aneurysms. METHODS A systematic literature review was performed on May 23, 2021, in PubMed, Web of Science, and Ovid MEDLINE for aneurysm treatment outcomes with IFD devices. Procedural details, including use of adjunctive devices and complications, were collected. The quality of studies was assessed using the Downs and Black checklist. Angiographic outcomes were classified as complete occlusion, residual neck, and residual aneurysm. Other outcomes included need for retreatment, permanent neurological deficit, and mortality. Pooled analyses were performed. RESULTS The final analysis comprised 1217 patients with 1249 aneurysms from 22 studies. The mean aneurysm diameter and neck width were 6.9 and 4.5 mm, respectively, and 27.6% of aneurysms were ruptured. The complete occlusion rates at 12 months and final follow-up (pooled mean duration 15.7 months) were 50.1% and 58.2%, respectively. Adjunctive devices were used in 6.4% of cases. The rates of hemorrhage, symptomatic infarction, permanent neurological deficit, and mortality were 1.2%, 2.8%, 1.0%, and 2.6%, respectively. CONCLUSIONS IFD is a very safe treatment for appropriately selected brain aneurysms with low complication and neurological deterioration rates. However, complete occlusion is achieved in only half of IFD-treated aneurysms at 1 year with a modest increase beyond this time point. As the majority of the studies were single arm, the pooled data are subject to selection and reporting biases. Future device developments, increased operator experience, and direct comparisons with alternative endovascular strategies and surgical clipping may clarify the role of IFD in aneurysm management.

2020 ◽  
pp. 159101992097623
Author(s):  
Qiaowei Wu ◽  
Li Li ◽  
Qiuji Shao ◽  
Tianming Xu ◽  
Kaitao Chang ◽  
...  

Background As a new endovascular reconstruction technique, flow diverter (FD) shows excellent efficacy and safety for treatment of intracranial aneurysms. In a previous multicenter, randomized, controlled, pre-market study, Tubridge FD showed remarkably higher complete occlusion rate compared with traditional stent-assisted coiling. However, a nonsignificant higher complication rate in the Tubridge group was noted. Considering the learning curve, the safety, and long-term outcomes of Tubridge FD should be verified in new prospective, real world, multicenter, post-market trials. Methods This study is a prospective, multicenter, single-arm, post-market clinical trial that evaluates the safety and efficacy of Tubridge in the treatment of patients with intracranial aneurysms by reconstructing parent artery. We expect 200 participants who meet the inclusion and exclusion criteria to be included. Clinical information and angiographic results (Raymond–Roy grading scale, RRGS) will be recorded objectively. The primary endpoint will be the complete occlusion rate of the target aneurysm (RRGS 1) at 12-month follow-up. Secondary endpoints will include the adequate occlusion rate (RRGS 1 & 2) and the rate of major in-stent stenosis (>50%) at 12-month follow-up, technique success rate, changes of modified Rankin Scale before and after the procedure, the rate of aneurysm related disability, neurological mortality, and all-cause mortality within follow-up period. Discussion This post-market, prospective trial may offer more information on the safety and long-term outcomes of Tubridge FD. When the study is complete, the results may provide us a new strategy for the treatment of intracranial aneurysms. Trial registration: WHO-Chinese Clinical Trial Registry: ChiCTR2000032282.


2019 ◽  
Vol 90 (3) ◽  
pp. e52.1-e52
Author(s):  
C Hannan ◽  
G Sunderland ◽  
R Zakaria ◽  
S Niven ◽  
H Nahser ◽  
...  

ObjectivesThe aim of this study was to assess the long-term outcomes of endovascular treatment of MCA aneurysms and identify factors associated with recurrence.Subjects161 aneurysms in 147 patients treated between January 2008 and August 2011.MethodsA retrospective case note review was performed. Aneurysm occlusion was assessed using the Raymond-Roy classification. Clinical outcome was graded using the mRS.ResultsThe minimum period of follow up was 65 months, with a maximum follow up period of 120 months. 49% of aneurysms were ruptured at the time of treatment. Morbidity was observed in 15% of the unruptured aneurysms (6% permanent neurological deficit), and in 33% of ruptured aneurysms (15% permanent neurological deficit). 84% of aneurysms were fully occluded following first treatment. Of these, 34% demonstrated angiographic recurrence and 10% required re-intervention. 25% of aneurysms≤7 mm in maximal diameter demonstrated angiographic recurrence, as compared with 50% of aneurysms>7 mm. Aneurysm size >7 mm was associated with a significantly shorter time to recurrence (log rank=9.655, p=0.002).ConclusionsThis is a large series of MCA aneurysms with a long period of follow up. Our results demonstrate that endovascular treatment of MCA aneurysms is associated with a low morbidity and mortality. Given the increasing use of adjunctive devices (stents, web devices) full occlusion of ruptured aneurysms in the acute phase is not necessary, and deliberate staged treatment a reasonable strategy.


2018 ◽  
Vol 25 (5) ◽  
pp. 522-538 ◽  
Author(s):  
Farzane Saeidifard ◽  
Jose R Medina-Inojosa ◽  
Marta Supervia ◽  
Thomas P Olson ◽  
Virend K Somers ◽  
...  

Background Replacing sitting with standing is one of several recommendations to decrease sedentary time and increase the daily energy expenditure, but the difference in energy expenditure between standing versus sitting has been controversial. This systematic review and meta-analysis aimed to determine this difference. Designs and methods We searched Ovid MEDLINE, Ovid Embase Scopus, Web of Science and Google Scholar for observational and experimental studies that compared the energy expenditure of standing versus sitting. We calculated mean differences and 95% confidence intervals using a random effects model. We conducted different predefined subgroup analyses based on characteristics of participants and study design. Results We identified 658 studies and included 46 studies with 1184 participants for the final analysis. The mean difference in energy expenditure between sitting and standing was 0.15 kcal/min (95% confidence interval (CI) 0.12–0.17). The difference among women was 0.1 kcal/min (95% CI 0.0–0.21), and was 0.19 kcal/min (95% CI 0.05–0.33) in men. Observational studies had a lower difference in energy expenditure (0.11 kcal/min, 95% CI 0.08–0.14) compared to randomised trials (0.2 kcal/min, 95% CI 0.12–0.28). By substituting sitting with standing for 6 hours/day, a 65 kg person will expend an additional 54 kcal/day. Assuming no increase in energy intake, this difference in energy expenditure would be translated into the energy content of about 2.5 kg of body fat mass in 1 year. Conclusions The substitution of sitting with standing could be a potential solution for a sedentary lifestyle to prevent weight gain in the long term. Future studies should aim to assess the effectiveness and feasibility of this strategy.


2008 ◽  
Vol 139 (2_suppl) ◽  
pp. P170-P170
Author(s):  
Hsin-Ching Lin ◽  
Michael Friedman

Objectives To study the long-term outcomes of radiofrequency turbinoplasty for the treatment of allergic rhinitis. Methods 146 consecutive patients who underwent radio-frequency turbinoplasty due to allergic rhinitis refractory to medical therapy were enrolled in this study. A 0–10 visual analog scale (VAS) was used to assess the allergic symptoms including nasal obstruction, rhinorrhea, sneezing, itchy nose, and itchy eyes preoperatively and 5 years postoperatively. The long-term clinical benefits and complications were reviewed. Statistical analysis was determined by paired t-test. Results None of the patients had obvious discomfort except mild numbness over the teeth (27/146, 18.5%) during operation. No long-term adverse reactions, including bleeding, infection, adhesion, or olfactory change were encountered. 119 patients had a minimum follow-up of 5 years and complete data available for analysis. The response rate was 60.5% (72/119). 18 patients received additional nasal surgery due to no obvious response to the surgery. These patients were excluded from the final analysis. 5 years after the treatment, the other 101 patients obtained improvement of nasal obstruction, with the VAS degree changing from 6.65 ± 1.92 to 4.45 ± 2.54 (p<0.0001). The VASs of rhinorrhea, sneezing, itchy nose, and itching eyes changed from 5.90 ± 2.79 to 3.79 ± 2.97, 5.15 ± 2.77 to 3.50 ± 2.77, 3.67 ± 3.03 to 2.41 ± 2.30 and 2.94 ± 3.02 to 2.02 ± 2.42, respectively (all p<0.0001). Conclusions The long-term study demonstrated that radiofrequency turbinoplasty appears to still be effective and safe for treating allergic rhinitis refractory to medical therapy.


Author(s):  
André Beer-Furlan ◽  
Krishna C. Joshi ◽  
Bledi Brahimaj ◽  
Demetrius K. Lopes

Abstract Objective Endovascular treatment of carotid-cavernous fistulas (CCFs) has been consistently shown to give excellent results and is currently the mainstay of treatment of these complex vascular pathologies. Onyx is currently the most widely used agent, but there has been concern over high rates of cranial nerve (CN) deficits seen in patients with CCF treated with Onyx and paucity of data on long-term outcomes. Methods This is a retrospective analysis of patients who underwent transvenous Onyx embolization between 2011 and 2018. The data collected included demographics, comorbidities, presenting symptoms, CCF morphology, degree of obliteration, procedure-related complications, clinical outcomes, and follow-up. Results A total of seven patients (five females) were included. The median age was 66 years (range: 15–79 years). Median duration of symptoms before treatment was 4 weeks (range: 1–24 weeks). There were three direct and four indirect CCFs. Barrow classification is as follows: A-3; B-3; C-0; and D-1. Immediate complete occlusion was achieved in all cases. There was also one case of immediate postoperative change in CN function (new partial CN VI deficit) that resolved completely at 1-month follow-up. The mean length of stay was 3 days (±2). The preoperative extraocular movement CN deficits had the following outcomes: three resolved; two improved; and one persisted. Proptosis, chemosis, conjunctival injection, and tinnitus were resolved in all patients. The median follow-up was 34 months (range: 10–91 months). Conclusion Transvenous Onyx embolization is a safe and effective treatment of CCFs when technical aspects to reduce complications are performed diligently. Our technique demonstrates safety of the Onyx as a stand-alone embolization for the treatment of CCF.


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 9504-9504 ◽  
Author(s):  
Caroline Robert ◽  
Georgina V. Long ◽  
Jacob Schachter ◽  
Ana Arance ◽  
Jean Jacques Grob ◽  
...  

9504 Background: Pembro demonstrated superior PFS and OS vs ipi in ipi-naive pts with advanced melanoma in the phase 3 KEYNOTE-006 study (NCT01866319). Here, we present long-term outcomes for all pts and in those pts who completed pembro therapy. Methods: Eligible pts (N = 834) were randomized 1:1:1 to pembro 10 mg/kg Q2W, pembro 10 mg/kg Q3W, or ipi 3 mg/kg Q3W for 4 doses. Treatment was continued for 2 yr (pembro only) or until disease progression, intolerable toxicity, or pt/investigator decision to discontinue. Per protocol, pts could interrupt pembro for ≤12 wk before discontinuation was required. Tumor imaging was performed at wk 12, then every 6 wk up to wk 48 and every 12 wk thereafter. After the prespecified final analysis, response assessments were per immune-related response criteria (irRC) by investigator review. Results: As of the data cutoff (Nov 3, 2016), median follow-up in the total population was 33.9 mo (range, 32.1-37.6). 33-mo OS rates were 50% in the pooled pembro arms (n = 556) and 39% in the ipi arm (n = 278); 33-mo PFS rates were 31% and 14%. ORR was 42% and 16%. Median duration of response was not reached for pembro (range 1.0+ to 33.8+ mo) or ipi (1.1+ to 34.8+ mo); 46 (68%) pembro-treated pts and 7 (58%) ipi-treated pts had a response lasting ≥30 mo. Among the 104/556 (19%) pts who completed pembro, median exposure to pembro was 24.0 mo (range 22.1-25.9). After a median follow-up of 9.0 mo after completion of pembro, 102 (98%) pts were alive. Responses were durable in pts who completed pembro; 9.7 mo after completion of pembro, estimated PFS (95% CI) was 91% (80-96) in all 104 pts, 95% (69-99) in pts with complete response (n = 24), 91% (74-97) in pts with partial response (n = 68), and 83% (48-96) in pts with stable disease (n = 12). Conclusions: Pembro provides durable efficacy after stopping the protocol-specified duration of treatment in pts with ipi-naive advanced melanoma in KEYNOTE-006. The estimated risk for progression or death nearly 10 mo after completing pembro is 9% and does not appear to differ by best response to pembro. Clinical trial information: NCT01866319.


2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Seyed Hosssein Ahmadi Tafti ◽  
Farshid Alaeddini ◽  
Mahmood Shirzad ◽  
Jamshid Bagheri ◽  
Abbas Salehi Omran ◽  
...  

Abstract Background Given that isolated tricuspid valve (TV) repair or replacement is performed relatively rarely, we sought to evaluate the rate of long-term mortality and readmission following this surgery. Methods The current study was conducted in Tehran Heart Center on patients who underwent isolated TV repair or replacement between 2010 and 2018. Totally, 197 patients (repair = 150 vs replacement = 47) were included in our study and were then followed right after surgery for a median of 8 years to assess the incidence of postoperative events, readmission, and all-cause mortality. Results The final analysis was conducted on 197 patients at a mean age of 44.4 ± 13.8 years. Most of the patients were female (56.9%). Ejection fraction, TAPSE, and right ventricular function improved in both groups after TV surgery. Length of stay in the intensive care unit per hour and hospitalization per day were higher in the replacement group and compared to the repair group (158.34 vs. 55.11 and 18.21 vs. 9.34, respectively). In-hospital mortality occurred in 20 patients, of whom 15 had TV replacement. Readmission occurred in five (2.5%) patients,all were in the repair group. Conclusions The result of this single-center study showed that TV replacement is associated with a higher rate of postoperative events and all-cause mortality compared to TV repair. Whereas, repair group had a higher rate of readmission. Therefore, the overwhelming tendency is toward repair; nonetheless, no hesitation is permissible if a replacement is adjudged to confer a better outcome for the patient.


Author(s):  
Oscar D. Guillamondegui

Traumatic brain injury (TBI) is a serious epidemic in the United States. It affects patients of all ages, race, and socioeconomic status (SES). The current care of these patients typically manifests after sequelae have been identified after discharge from the hospital, long after the inciting event. The purpose of this article is to introduce the concept of identification and management of the TBI patient from the moment of injury through long-term care as a multidisciplinary approach. By promoting an awareness of the issues that develop around the acutely injured brain and linking them to long-term outcomes, the trauma team can initiate care early to alter the effect on the patient, family, and community. Hopefully, by describing the care afforded at a trauma center and by a multidisciplinary team, we can bring a better understanding to the armamentarium of methods utilized to treat the difficult population of TBI patients.


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