scholarly journals One and done? The effect of number of Pipeline embolization devices on aneurysm treatment outcomes

2019 ◽  
Vol 26 (2) ◽  
pp. 147-155
Author(s):  
Muhammad Waqas ◽  
Kunal Vakharia ◽  
Andrew D Gong ◽  
Hamid H Rai ◽  
Audrey Wack ◽  
...  

Background Controversy exists regarding the optimum number of flow diverters for the treatment of intracranial aneurysms. We explored the effect of the number of Pipeline embolization devices (PEDs; Medtronic, Dublin, Ireland) deployed on rates of aneurysm occlusion and complications. Methods Consecutive patients who underwent saccular intracranial aneurysm treatment solely with the PED were included in this retrospective study. Computed tomographic, magnetic resonance, or digital subtraction angiographic images at 6 and 12 months and last follow-up (>12 months) were reviewed for aneurysm occlusion. Complication and retreatment rates were recorded and analyzed statistically. Results The study included 141 aneurysm treatments in 119 patients. A single PED was deployed in 105 cases, two PEDs in 31 cases, and three PEDs in 5 cases (total = 182 devices). Six-month angiographic data were available for 103 patients. Occlusion rates were 67.1% for single-PED cases and 90.0% for cases with > 1 PED (p = 0.028). The 12-month occlusion rate (follow-up available for 132) for single-PED cases was 74.7% compared to 91.7% for multiple-PED cases (p = 0.04). On multivariate analysis, number of PEDs was an independent predictor of aneurysm occlusion at 12 months (odds ratio 6.3, 95% confidence interval 1.8–22.8, p = 0.005). Thromboembolic complication rates were the same in the single- and multiple-PED treatment groups (2.8%). The retreatment rate was higher in patients treated with a single PED (16.2% vs. 0%, p = 0.01). Conclusions Deployment of > 1 Pipeline embolization device was associated with higher intracranial aneurysm occlusion and lower retreatment rates. No significant difference was found in complication rates.

Stroke ◽  
2013 ◽  
Vol 44 (suppl_1) ◽  
Author(s):  
Nauman Tariq ◽  
Nathan Sit ◽  
Malik M Adil ◽  
Ashter Rizvi ◽  
Waqas I Gilani ◽  
...  

Background: The American Heart Association (AHA) recommends early aneurysm treatment without specifying any specific time intervals in patients with subarachnoid hemorrhage [SAH] [Bederson JB, et al.Stroke. 2009;40:994-1025].The AHA further requires documentation of proportion of SAH patients treated within 36 hours after admission as a Quality of Care metrics in Comprehensive Stroke Centers. [Leifer D, et al. Stroke. 2011; 42: 849-877]However, the definition of early treatment remains controversial. Objective: To determine the rates of outcomes associated with ultra-early (<12 hours) and delayed (≥12 hours) intracranial aneurysm treatment after admission in patients with SAH. Methods: We analyzed the data from 144 consecutive SAH patients from two academic centers who underwent endovascular treatment of ruptured intracranial aneurysms over a period of 4 years. Pre procedure rebleeding was defined by an acute neurological deterioration associated with new hemorrhage apparent on a computed tomographic (CT) scan or an increase in hemorrhage burden on a repeat CT scan. Favorable outcome was defined as modified Rankin score of ≤2 at discharge. Baseline characteristics and outcomes were compared between ultra-early (<12 hours) and delayed (≥12 hours) treatment using univariate analysis and by multivariate analysis after adjustment for confounders. Results: Of the 144 SAH patients (mean age 54±SD: 13). Ninety nine ( 68% ) were women who underwent endovascular intracranial aneurysm treatment, (58%) underwent ultra-early aneurysm treatment. After adjusting for age, Hunt and Hess and Fisher grades, there was no significant difference in rates of favorable outcomes (odd ratio [OR] 0.6, 95% confidence interval [CI](0.2-1.3) or in-hospital mortality (OR 0.8, 95% CI (0.3-2.3) between the two groups. Pre procedure rebleeding was less likely to occur in the ultra-early treatment group (OR 0.1; 95% CI 0.02-0.4, p<0.002). Conclusions: Ultra-early aneurysm treatment is possible due to the availability of endovascular treatment and appears to significantly reduce the pre-procedural rebleeding rates in patients with SAH.


2021 ◽  
Vol 10 (10) ◽  
pp. 2054
Author(s):  
Gerasimos Kopsinis ◽  
Dimitrios Tsoukanas ◽  
Dimitra Kopsini ◽  
Theodoros Filippopoulos

Conjunctival wound healing determines success after filtration surgery and the quest for better antifibrotic agents remains active. This study compares intracameral bevacizumab to sub-Tenon’s mitomycin C (MMC) in trabeculectomy. Primary open-angle or exfoliative glaucoma patients were randomized to either bevacizumab (n = 50 eyes) or MMC (n = 50 eyes). The primary outcome measure was complete success, defined as Intraocular Pressure (IOP) > 5 mmHg and ≤ 21 mmHg with a minimum 20% reduction from baseline without medications. Average IOP and glaucoma medications decreased significantly in both groups at all follow-up points compared to baseline (p < 0.001), without significant difference between groups at 3 years (IOP: bevacizumab group from 29 ± 9.4 to 15 ± 3.4 mmHg, MMC group from 28.3 ± 8.7 to 15.4 ± 3.8 mmHg, p = 0.60; Medications: bevacizumab group from 3.5 ± 0.9 to 0.5 ± 1, MMC group from 3.6 ± 0.7 to 0.6 ± 1.1, p = 0.70). Complete success, although similar between groups at 3 years (66% vs. 64%), was significantly higher for bevacizumab at months 6 and 12 (96% vs. 82%, p = 0.03; 88% vs. 72%, p = 0.04, respectively) with fewer patients requiring medications at months 6, 9 and 12 (4% vs. 18%, p = 0.03; 6% vs. 20%, p = 0.04; 8% vs. 24%, p = 0.03, respectively). Complication rates were similar between groups. In conclusion, intracameral bevacizumab appears to provide similar long-term efficacy and safety results as sub-Tenon’s MMC after trabeculectomy.


2021 ◽  
Vol 10 (9) ◽  
pp. 1865
Author(s):  
Stefan M. Froschauer ◽  
Matthias Holzbauer ◽  
Dietmar Hager ◽  
Oskar Kwasny ◽  
Dominik Duscher

High complication rates in total wrist arthroplasty (TWA) still lead to controversy in the medical literature, and novel methods for complication reduction are warranted. In the present retrospective cohort study, we compare the outcomes of the proximal row carpectomy (PRC) method including total scaphoidectomy (n = 22) to the manufacturer’s conventional carpal resection (CCR) technique, which retains the distal pole of the scaphoid (n = 25), for ReMotion prosthesis implantation in non-rheumatoid patients. Mean follow-up was 65.8 ± 19.8 and 80.0 ± 28.7 months, respectively. Pre- and postoperative clinical assessment included wrist flexion-extension and radial-ulnar deviation; Disability of Arm, Shoulder, and Hand scores; and pain via visual analogue scale. At final follow-up, grip strength and satisfaction were evaluated. All complications, re-operations, and revision surgeries were noted. Clinical complications were significantly lower in the PRC group (p = 0.010). Radial impaction was detected as the most frequent complication in the CCR group (n = 10), while no PRC patients suffered from this complication (p = 0.0008). Clinical assessment, grip strength measurements, and the log rank test evaluating the re-operation as well as revision function showed no significant difference. All functional parameters significantly improved compared to preoperative values in both cohorts. In conclusion, we strongly recommend PRC for ReMotion prosthesis implantation.


2021 ◽  
pp. 159101992110279
Author(s):  
Muhammad Waqas ◽  
Rimal H Dossani ◽  
Modhi Alkhaldi ◽  
Jocelyn Neveu ◽  
Justin M Cappuzzo ◽  
...  

Introduction The Flow Redirection Endoluminal Device (FRED; MicroVention) is a dual-layered flow diverter used for the treatment of intracranial aneurysms. The objective of this systematic review was to compile device-related safety and effectiveness data. Methods The literature from January 1, 2013 to April 30, 2021 was searched for studies describing use of the FRED for intracranial aneurysm treatment irrespective of aneurysm location and morphology. The review included anterior and posterior circulation ruptured and unruptured saccular, fusiform or dissection, and blister aneurysms. MeSH terms related to “flow re-direction endoluminal device” and “FRED for aneurysms” were used. Data related to indication, complications, and rates of aneurysm occlusion were retrieved and analyzed. Results Twenty-two studies with 1729 intracranial aneurysms were included in this review. Overall reported morbidity was 3.9% (range 0–20%). Overall procedure-related mortality was 1.4% (range 0–6%). Complication rates fell into 5 categories: technical (3.6%), ischemic (3.8%), thrombotic or stenotic (6%), hemorrhagic (1.5%), and non-neurological (0.8%). The aneurysm occlusion rate between 0 and 3 months (reported in 11 studies) was 47.8%. The occlusion rate between 4 and 6 months (reported in 14 studies) was 73.8%. Occlusion rates continued to increase to 75.1% at 7–12 months (reported in 10 studies) and 86.6% for follow-up beyond 1 year (reported in 10 studies). Conclusion This review indicated that the FRED is a safe and effective for the treatment of intracranial aneurysms. Future studies should directly compare the FRED with other flow diverters for a better understanding of comparative safety and effectiveness among the different devices.


Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Joan M ODonnell ◽  
Maurizio Manuguerra ◽  
Jemma L Hodge ◽  
Greg Savage ◽  
Michael K Morgan

Background: Studies have questioned the effectiveness of surgery for the management of unruptured intracranial aneurysm (uIA). Few studies have examined the ability to drive and quality of life (QOL) after surgery for uIA. Objective: This study examined the effectiveness of surgical management of uIA by measuring patients’ perceived quality of life and their cognitive abilities related to driving. Methods: Between January 2011 and January 2016 patients with a uIA were assessed using the Quality Metric Short Form 36 (SF36) and the off-road driver screening instrument DriveSafeDriveAware. Reassessments were conducted at the 6-week post-operative follow-up for surgical patients and at 12-month follow-up for surgical and conservatively managed patients. Results: 175 patients enrolled in the study, of which 112(66%) had surgical management of their aneurysm. For the surgical cases who completed all assessments (N=74), there was a trend for the DriveSafe pre-operative mean score of 108 (SD 10.7) to be lower than the 6-week and 12-month post-operative mean scores (111 SD 9.7 and 112 SD 10.2 respectively)(p=0.05). There were no significant changes in DriveAware scores at any epoch or between patient groups nor in the MCS in the surgical group.. There was a significant decline in PCS scores at 6 weeks post-operatively which recovered at 12 months (52 SD 8.1, 46 SD 6.8 and 52 SD 7.1 respectively)( p <0.01). There was no significant difference in 12-month mRS scores between the surgical cases who completed with cases who did not complete all assessments. Conclusion: Surgery for uIA did not affect cognitive abilities for driving at 6 weeks or 12 months after surgery. There was a decline in the QOL in the first months after surgery, however QOL returned to pre-surgical status 12 months after surgery. If the risk of seizures is low and there are no post-operative complications, returning to driving can be recommended.


Stroke ◽  
2013 ◽  
Vol 44 (suppl_1) ◽  
Author(s):  
Xuemei Cai ◽  
Susannah Orzell ◽  
Sarah Suh ◽  
Linda Bresette ◽  
Farzaneh Sorond ◽  
...  

INTRODUCTION: Warfarin-associated intracerebral hemorrhage (wICH) remains the most lethal form of iatrogenic stroke. Conventional therapy with fresh frozen plasma (FFP) and intravenous vitamin K takes up to 30 hrs to normalize the international normalized ratio (INR). Prothrombin complex concentrate (PCC) does not require cross-match and is fast acting. We hypothesized that PCC can rapidly reverse coagulopathy and reduce mortality in wICH. Methods: We identified 130 consecutive adult wICH patients over five years from a prospectively collected database. 33 patients were excluded for death or withdrawal of care within 48 hours of admission and 8 patients were excluded for antecedent head trauma, leaving 89 patients for analysis. Forty patients received FFP and vitamin K (conventional therapy) and 49 received PCC in addition to conventional therapy. We compared 6-month mortality, time to INR normalization, quantity of FFP transfused, and thromboembolic complication rates between the two groups. We used logistic regression to adjust for important confounders. Results: PCC-treated and conventional therapy patients had similar distributions of age, sex, co-morbidities, ICH location, initial blood pressure and INR. PCC-treated patients had a higher incidence of intraventicular hemorrhage (IVH) (67% vs 33%). PCC-treated patients required less FFP (mean 6.8 units vs 3.3 units, p<0.0001) and had faster time to INR normalization (mean 3.8 hrs vs 9.8 hrs, p<0.0001). Incidence of ICH expansion was low in both groups. There was no difference in the incidence of deep venous thrombosis and pulmonary embolism (p=0.236) or troponin elevation (p=0.573). There was no significant difference in 6-month mortality (p=0.437) after adjusting for age, ICH location, ICH volume, and presence of IVH. Conclusions: PCC use in wICH was associated with shorter time to INR normalization and reduced FFP transfusion but was not associated with 6-month mortality in this cohort. There was no difference in thromboembolic complication rates between PCC-treated and FFP and vitamin K treated patients. Prospective trials of PCC are necessary to determine if its use can improve morbidity and mortality in wICH and to identify potential subgroups of wICH patients who may benefit from PCC.


2019 ◽  
Vol 32 (Supplement_2) ◽  
Author(s):  
Vrakopoulou Gavriella Zoi ◽  
Di Maggio Francesco ◽  
Barbieri Lavinia ◽  
Zeki Sebastian ◽  
Dunn Jason M ◽  
...  

Abstract Aim This study aimed to compare the efficacy and safety of LHM and POEM for esophageal achalasia. Background & Methods Laparoscopic Heller’s myotomy (LHM) has been the gold standard of treatment, however per-oral endoscopic myotomy (POEM) was recently established as a treatment option for achalasia. A prospective review was performed for all patients submitted to LHM or POEM in our institution from 10/2012 to 06/2018, and have completed a minimum follow up period of 6 months. The diagnostic work-up included gastroscopy, barium study and high-resolution manometry (HRM). All patients underwent a clinical evaluation 6 weeks after treatment and a surveillance gastroscopy in the 1st postoperative year. HRM and pH studies were offered to all patients after 6 months. Standardized questionnaires evaluating Eckardt, GERD and achalasia QoL (Urbach) scores were completed pre- and postoperatively. Statistical analyses were performed with SPSS version 23.0. Repeated measurements analysis of variance was used to compare changes in mean values during follow up and between the two types of surgery. P values < 0.05 were considered significant. Results Eighty patients (34 women and 46 men) with mean age 42.6 years (16.2) underwent POEM (n=39) or LHM (n=41). QoL score was significantly improved in both study groups (p<0.001) with a similar degree of improvement (p=0.486). Eckardt scores showed a significant improvement in both groups, but repeated measurements analysis revealed a significant effect with time (p=0.038) with a greater improvement in POEM group. Moreover, Eckardt score change was similar between LHM and POEM patients without prior treatments (p=0.724), but in those with prior treatments the improvement trended higher in POEM group (p=0.087). GERD score had a similar and significant decrease in both groups (p=0.439), but in those with prior treatments the improvement was greater in LHM group (p=0.018). There was no significant difference regarding the complication rates for both groups (Clavien-Dindo I-IIIa). Conclusions POEM compares favorably with LHM as treatment for achalasia, as statistically significant improvement in QoL, GERD and Eckardt scores was recorded in both groups. In patients with prior treatments, POEM tends to achieve a greater improvement of Eckardt score and LHM a greater reduction regarding GERD score.


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):  
Yong-Soo Baek ◽  
Oh-Seok Kwon ◽  
Byounghyun Lim ◽  
Song-Yi Yang ◽  
Je-Wook Park ◽  
...  

Background: Clinical recurrence after atrial fibrillation catheter ablation (AFCA) still remains high in patients with persistent AF (PeAF). We investigated whether an extra-pulmonary vein (PV) ablation targeting the dominant frequency (DF) extracted from electroanatomical map–integrated AF computational modeling improves the AFCA rhythm outcome in patients with PeAF.Methods: In this open-label, randomized, multi-center, controlled trial, 170 patients with PeAF were randomized at a 1:1 ratio to the computational modeling-guided virtual DF (V-DF) ablation and empirical PV isolation (E-PVI) groups. We generated a virtual dominant frequency (DF) map based on the atrial substrate map obtained during the clinical AF ablation procedure using computational modeling. This simulation was possible within the time of the PVI procedure. V-DF group underwent extra-PV V-DF ablation in addition to PVI, but DF information was not notified to the operators from the core lab in the E-PVI group.Results: After a mean follow-up period of 16.3 ± 5.3 months, the clinical recurrence rate was significantly lower in the V-DF than with E-PVI group (P = 0.018, log-rank). Recurrences appearing as atrial tachycardias (P = 0.145) and the cardioversion rates (P = 0.362) did not significantly differ between the groups. At the final follow-up, sinus rhythm was maintained without any AADs in 74.7% in the V-DF group and 48.2% in the E-PVI group (P &lt; 0.001). No significant difference was found in the major complication rates (P = 0.489) or total procedure time (P = 0.513) between the groups. The V-DF ablation was independently associated with a reduced AF recurrence after AFCA [hazard ratio: 0.51 (95% confidence interval: 0.30–0.88); P = 0.016].Conclusions: The computational modeling-guided V-DF ablation improved the rhythm outcome of AFCA in patients with PeAF.Clinical Trial Registration: Clinical Research Information Service, CRIS identifier: KCT0003613.


2018 ◽  
Vol 2018 ◽  
pp. 1-10 ◽  
Author(s):  
Ali H. Hachem ◽  
Joseph E. Marine ◽  
Housam A. Tahboub ◽  
Sana Kamdar ◽  
Shaffi Kanjwal ◽  
...  

Background. Pulmonary vein isolation is commonly performed using radiofrequency energy with cryoablation gaining acceptance. We performed a meta-analysis of randomized controlled trials which compared radiofrequency versus cryoablation for patients with atrial fibrillation. Methods. A systematic search strategy identified both published and unpublished articles from inception to November 10, 2016, in multiple databases. The primary outcomes for this meta-analysis were long-term freedom from atrial fibrillation at 12-month follow-up and overall postoperative complication rates. For all included studies, the methodological quality was assessed through the Cochrane Collaboration’s tool for risk of bias. Results. A total of 247 articles were identified with eight being included in this review as they satisfied the prespecified inclusion criteria. Overall, there was no significant difference in freedom from atrial fibrillation at ≥12-month follow-up between those receiving cryoballoon and radiofrequency ablation, respectively (OR = 0.98, CI = 0.67–1.43, I2 = 56%, p=0.90). Additionally, the secondary outcomes of duration of ablation, fluoroscopy time, and ablation time failed to reach significance. Cryoballoon ablation had significantly greater odds of postoperative phrenic nerve injury at 12-month follow-up. Conclusions. Our meta-analysis suggests that cryoballoon ablation provides comparable benefits with regard to freedom from atrial fibrillation at medium-term follow-up, fluoroscopy time, ablation time, operative duration, and overall complication rate in comparison to radiofrequency ablation.


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