scholarly journals Utility of invasive electroencephalography in children 3 years old and younger with refractory epilepsy

2020 ◽  
Vol 26 (6) ◽  
pp. 648-653
Author(s):  
Rafael Uribe-Cardenas ◽  
Andre E. Boyke ◽  
Justin T. Schwarz ◽  
Peter F. Morgenstern ◽  
Jeffrey P. Greenfield ◽  
...  

OBJECTIVEEarly surgical intervention for pediatric refractory epilepsy is increasingly advocated as surgery has become safer and data have demonstrated improved outcomes with early seizure control. There is concern that the risks associated with staged invasive electroencephalography (EEG) in very young children outweigh the potential benefits. Here, the authors present a cohort of children with refractory epilepsy who were referred for invasive monitoring, and they evaluate the role and safety of staged invasive EEG in those 3 years old and younger.METHODSThe authors conducted a retrospective review of children 3 years and younger with epilepsy, who had been managed surgically at two institutions between 2001 and 2015. A cohort of pediatric patients older than 3 years of age was used for comparison. Demographics, seizure etiology, surgical management, surgical complications, and adverse events were recorded. Statistical analysis was completed using Stata version 13. A p < 0.05 was considered statistically significant. Fisher’s exact test was used to compare proportions.RESULTSNinety-four patients (45 patients aged ≤ 3 [47.9%]) and 208 procedures were included for analysis. Eighty-six procedures (41.3%) were performed in children younger than 3 years versus 122 in the older cohort (58.7%). Forty-two patients underwent grid placement (14 patients aged ≤ 3 [33.3%]); 3 of them developed complications associated with the implant (3/42 [7.14%]), none of whom were among the younger cohort. Across all procedures, 11 complications occurred in the younger cohort versus 5 in the older patients (11/86 [12.8%] vs 5/122 [4.1%], p = 0.032). Two adverse events occurred in the younger group versus 1 in the older group (2/86 [2.32%] vs 1/122 [0.82%], p = 0.571). Following grid placement, 13/14 younger patients underwent guided resections compared to 20/28 older patients (92.9% vs 71.4%, p = 0.23).CONCLUSIONSWhile overall complication rates were higher in the younger cohort, subdural grid placement was not associated with an increased risk of surgical complications in that population. Invasive electrocorticography informs management in very young children with refractory, localization-related epilepsy and should therefore be used when clinically indicated.

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 54.1-54
Author(s):  
S. Benamar ◽  
C. Lukas ◽  
C. Daien ◽  
C. Gaujoux-Viala ◽  
L. Gossec ◽  
...  

Background:Polypharmacy is steadily increasing in patients with rheumatoid arthritis (RA). They may interfere with treatment response and the occurrence of serious adverse events. Medications taken by a patient may reflect active comorbidities, whereas comorbidity indices usually used include past or current diseases.Objectives:To evaluate whether polypharmarcy is associated with treatment response and adverse events in an early RA cohort and to establish whether polypharmacy could represent a substitute of comorbidities.Methods:We used data from the French cohort ESPOIR, including 813 patients with early onset arthritis. Patients included the current study had to start their first disease modifying anti-rheumatic drug (DMARD) within 24 months of inclusion in the cohort. Disease activity data were collected at one, five and ten years from the initiation of the first DMARD. For each patient, treatments were collected at baseline and at five years. Medications count included all specialties other than background RA therapy, analgesics/NSAIDs and topicals. Polypharmacy was defined as a categorical variable based on the median and tertiles of distribution in the cohort. Treatment response was assessed by achieving DAS28 ESR remission (REM) at 1 year, 5 years and 10 years from the initiation of the first DMARD. The occurrence of severe adverse events (SAE) was measured by the occurrence of severe infection, hospitalization, or death during the 10-year follow-up. The association between patient’s characteristics and achievement of REM and occurrence of SAE were tested in univariate analysis. A logistic regression model was used to evaluate associations between polypharmacy and REM at 1 year, 5 years and 10 years (we used baseline polypharmacy for the 1-year analysis and five years polypharmacy for the 5- and 10-years analyses). Multivariate adjustment was made for age, sex, BMI, duration of disease, initial DAS28 ESR, initial HAQ, smoking status, rheumatic disease comorbidity index (RDCI).Results:The proportion of patients who achieved REM one year after the initiation of the first DMARD was 32.1% in the polypharmacy according to the median group (patients taken ≥2 medication) versus 67.9% in the non-polypharmacy group (p=0.07). At 5 years after the first DMARD, the proportion of patients with REM was 45.0% in the polypharmacy group versus 56.3% in the non-polypharmacy group (p=0.03). At 10 years the proportion of patients with REM was 32.5% in the polypharmacy group versus 67.5% (p=0.06). Patients who take greater or equal to 2 medications had a 40% lower probability of achieving REM (OR = 0.60 [0.38-0.94] p = 0.03) at 5 years from the first DMARD (if RDCI index was not included in the model). At 10 years, patients receiving multiple medications had a 43% lower probability of achieving REM (OR = 0.57 [0.34-0.94] p = 0.02). SAE incidence was 61 per 1000 patient-years. For patients who developed SAE all causes 71.4% where in the polypharmacy group versus 57.8% were in the non-polypharmacy group (p = 0.03; univariate analysis). These results are no longer significant after adjustment for comorbidities indices.Conclusion:In this early RA cohort, polypharmacy is associated with a poorer treatment response and increased risk of adverse events. Polypharmacy may represent a good substitute of comorbidities for epidemiological studies.Acknowledgements:We are grateful to Nathalie Rincheval (Montpellier) who did expert monitoring and data management and all theinvestigators who recruited and followed the patients (F. Berenbaum, Paris-Saint Antoine; MC. Boissier, Paris-Bobigny; A. Cantagrel, Toulouse; B. Combe, Montpellier; M. Dougados, Paris-Cochin; P. Fardellone and P. Boumier, Amiens; B. Fautrel, Paris-La Pitié; RM. Flipo, Lille; Ph. Goupille, Tours; F. Liote, Paris- Lariboisière; O. Vittecoq, Rouen; X. Mariette, Paris-Bicêtre; P. Dieude, Paris Bichat; A. Saraux, Brest; T. Schaeverbeke, Bordeaux; and J. Sibilia, Strasbourg).The work reported on in the manuscript did not benefit from any financial support. The ESPOIR cohort is sponsored by the French Society for Rheumatology. An unrestricted grant from Merck Sharp and Dohme (MSD) was allocated for the first 5 years. Two additional grants from INSERM were obtained to support part of the biological database. Pfizer, Abbvie, Lilly and more recently Fresenius and Biogen also supported the ESPOIR cohort.Disclosure of Interests:Soraya Benamar: None declared, Cédric Lukas Speakers bureau: Abbvie, Amgen, Janssen, Lilly, MSD, Novartis, Pfizer, Roche-Chugai, UCB, Consultant of: Abbvie, Amgen, Janssen, Lilly, MSD, Novartis, Pfizer, Roche-Chugai, UCB, Grant/research support from: Pfizer, Novartis and Roche-Chugai, Claire Daien Speakers bureau: AbbVie, Abivax, BMS, MSD, Roche, Chugai, Novartis, Pfizer, Sandoz, Lilly, Consultant of: AbbVie, Abivax, BMS, MSD, Roche, Chugai, Novartis, Pfizer, Sandoz, Lilly, Cécile Gaujoux-Viala Speakers bureau: Abbvie, BMS, Celgene, Janssen, Medac, MSD, Nordic Pharma, Novartis, Pfizer, Sanofi, Roche-Chugai, UCB, Consultant of: Abbvie, BMS, Celgene, Janssen, Medac, MSD, Nordic Pharma, Novartis, Pfizer, Sanofi, Roche-Chugai, UCB, Grant/research support from: Pfizer, Laure Gossec Speakers bureau: AbbVie, Amgen, Biogen, Celgene, Janssen, Lilly, Novartis, Pfizer, Sandoz, Sanofi-Aventis et UCB, Consultant of: AbbVie, Amgen, Biogen, Celgene, Janssen, Lilly, Novartis, Pfizer, Sandoz, Sanofi-Aventis et UCB, Anne-Christine Rat Speakers bureau: Pfizer, Lilly, Consultant of: Pfizer, Lilly, Bernard Combe Speakers bureau: AbbVie; Bristol-Myers Squibb; Gilead; Janssen; Lilly; Merck; Novartis; Pfizer; Roche-Chugai; and Sanofi;, Consultant of: AbbVie; Bristol-Myers Squibb; Gilead; Janssen; Lilly; Merck; Novartis; Pfizer; Roche-Chugai; and Sanofi;, Grant/research support from: Novartis, Pfizer, and Roche-Chugai., Jacques Morel Speakers bureau: Abbvie, BMS, Lilly, Médac, MSD, Nordic Pharma, Pfizer, UCB, Consultant of: Abbvie, BMS, Lilly, Médac, MSD, Nordic Pharma, Pfizer, UCB, Grant/research support from: BMS, Pfizer


2019 ◽  
Vol 29 (Supplement_4) ◽  
Author(s):  
M Laanani ◽  
A Weill ◽  
P O Blotière ◽  
J Pouchot ◽  
F Carbonnel ◽  
...  

Abstract Background More than one million colonoscopies are performed every year in France. They are associated with risks of mechanical and systemic serious adverse events (SAEs) which can be associated with patient, procedure, endoscopist, and facility characteristics. We tried to identify the factors associated with colonic perforation, gastrointestinal bleeding, splenic injury, shock, myocardial infarction, stroke, pulmonary embolism, acute renal failure, and urolithiasis after colonoscopy. Methods We analysed data from the French national claims databases (SNDS). A total of 4,088,799 patients, 30 years or older, undergoing a first screening or diagnostic colonoscopy between 2010 and 2015 were identified. SAE rates were estimated, and risk factors associated with SAEs were identified using multilevel logistic regression models, adjusted for patient, colonoscopy, endoscopist, and facility characteristics. Results Increasing age was associated with an increasing incidence of mechanical and systemic SAEs. Cancer and cardiovascular comorbidities were associated with mechanical SAEs, and a higher number of pre-existing conditions was associated with shock and acute renal failure. Polypectomy, especially of polyps larger than 1 cm, was associated with an increased risk of perforation (OR = 4.1; 95% CI, 3.4-5.0) and bleeding (OR = 13.3; 95% CI, 11.7-15.1). Mechanical SAEs were associated with the endoscopist’s experience, while systemic SAEs were more frequent in public hospitals than in private clinics. Conclusions SAEs related to colonoscopy were more frequent in older patients and in those with comorbidities. Mechanical SAEs were more frequent when colonoscopy was performed by less experienced endoscopists. Systemic SAEs were more frequent in public hospitals, reflecting patient selection processes. The risk of both mechanical and systemic SAEs should be taken into account when deciding to perform colonoscopy, particularly in older patients with multiple pre-existing conditions. Key messages Systemic SAEs are not uncommon after colonoscopy and, together with intestinal SAEs, should be considered when considering the need for colonoscopy. Patients at risk of SAEs should be identified and colonoscopy should be performed by experienced endoscopists in these patients. Less invasive alternatives should also be considered in these patients.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 12026-12026
Author(s):  
Anna Claire Olsson-Brown ◽  
Mark Baxter ◽  
Caroline Dobeson ◽  
Laura Feeney ◽  
Rebecca Lee ◽  
...  

12026 Background: Immune checkpoint inhibitor (ICI) therapy is now commonly used in a range of tumours and settings. Most data relating to outcomes and rates of immune-related adverse events (irAE) is derived from clinical trial or registry populations and small case series. Limited data exist for patients aged > 75 years. Here we present a multi-centre, real-world analysis of the outcomes and incidence of irAEs in older adults managed within a single comprehensive public health service. We also compare these outcomes to younger patients in the same cohort. Methods: A retrospective analysis of 2049 patients treated with ICIs was undertaken across 12 centres. All patients were managed within the UK National Health Service outside of a trial setting between June 2016 and September 2018. Patients received either ICI monotherapy (MT) or duel combination ICI therapy (CT) for malignant melanoma (MM), non-small cell lung cancer (NSCLC) or renal cell cancer (RCC). Data were collected using a standardised, collection tool. IrAEs ≥ grade 2 or all-grade endocrinopathies were recorded as per the Common Terminology Criteria for Adverse Events (V5) (CTCAE). Statistical analyses were performed using T-tests, Mann-Whitney and Chi-squared. Kaplan-Meier analysis and log-rank test were used for overall survival (OS) analysis. Results: 409 (20%) of patients were aged > 75 years(a), 1413 (69%) aged 50-75(b) and 227 (11.1%) aged < 50(c). There was no difference in sex, ethnicity or PD-L1 status (in the NSCLC cohort) between groups. Older patients were less likely to receive combination therapy (3%(a) v 13%(b) v 34%(c), p < 0.001). There was no difference in median OS across age groups in the cohort as a whole (p = 0.822) or for the individual tumour groups when treated with single agent ICI. Across the total cohort patients aged > 75 had no increased risk of any irAE (35%(a) v 33%(b) v 41%(c),p = 0.074). However there was an increase in irAEs in older patients treated with MT (36%(a) v 26(b) v 25%(c), p = 0.011) However there was no difference in the > 75s with regard to severe (G3/4) toxicity, toxicity type, admission or discontinuation due to toxicity in the aPD-1 group. In the overall cohort younger patients were more likely to develop irAEs and be admitted. Conclusions: Patients aged > 75 years treated with anti-PD1 therapy in the standard of care setting derive similar survival benefit to younger patients. There was no increase in ≥G3 toxicity. Our data support the safety of single agent aPD-1 ICI therapy in older adults and provide reassurance relating to the impact of toxicity.[Table: see text]


2020 ◽  
Vol 8 (Suppl 3) ◽  
pp. A695-A695
Author(s):  
Sabina Sandigursky ◽  
Safa Houssein ◽  
Xerxes Pundole ◽  
Elizaveta Efuni ◽  
Samuel Cytryn ◽  
...  

BackgroundAutoimmunity is associated with increased risk of malignancy. However, patients with pre-existing autoimmune diseases (AIDs) were excluded from immune checkpoint inhibitor (ICI) trials as these agents can cause immune-related adverse events (irAEs). Data are limited on the safety and efficacy of combination immunotherapy in this at-risk population.MethodsWe conducted a multi-center retrospective study to evaluate the safety and efficacy of ICI therapy in patients with pre-existing AID treated at NYU and at MD Anderson Cancer Center. Primary endpoints were occurrence of irAEs and AID flares. Secondary endpoints were time to treatment failure (TTF) and overall survival (OS).ResultsOf 121 patients identified from our institutional databases, 53% received single-agent anti-PD-1 therapy, and 47% received ICI combination. Over half of malignancies were lung cancer (34%) and melanoma (20%). Preexisting AIDs included: rheumatologic (58%), gastrointestinal (12%), endocrine (16%) and neurologic (4%). Overall, 94% had asymptomatic AID, and 21% were receiving systemic immunomodulatory drugs at ICI initiation. Median duration of follow up after ICI initiation was 9 (0.4–41.9) months in patients receiving ICI combination and 8 (0.2–47.3) months in patients receiving anti-PD-1 monotherapy. Combination therapy was associated with higher rates of irAEs compared with anti-PD-1 monotherapy (56% versus 28%). Grade 3/4 irAEs were equivalent in both groups: combination (38%) and anti-PD-1 group (39%). Treatment related deaths were not observed in any group. AID flares occurred in 36% of the anti-PD-1 group versus 29% of combination group. Adverse events (irAEs and/or flares) required systemic immunomodulatory therapies more frequently in the combination group (84%) versus the anti-PD-1 group (59%), and permanent ICI discontinuation was reported in 19% of patients in the combination group versus 11% in the anti-PD-1 group. Tumor progression was observed in 49% of patients on combination ICI and TTF was 14.5 months (95% CI 0.000–31.5), while progression was observed in 64% of patients on anti-PD-1 monotherapy and TTF was 6.4 months (95% CI 4.01–8.9) (p=0.019). Median OS in the combination therapy group was not reached whereas it was 27.3 months in the anti-PD-1 monotherapy group.ConclusionsOur novel findings suggest that high rates of adverse events were observed in patients with pre-existing AIDs treated with ICI combination therapy. However, they were manageable and rarely required permanent ICI discontinuation. Taken together, these data show that ICIs should be offered, albeit with caution in patients with AIDs, to achieve durable cancer remission. Prospective clinical data are needed to guide these complex decisions.Ethics ApprovalThe study was approved by NYU Langone’s Ethics Board, approval number i18-01657 and MD Anderson’s Ethics Board, approval number PA19-0089


2015 ◽  
Vol 25 (6) ◽  
pp. 509-513 ◽  
Author(s):  
Catherine S. Lee ◽  
Lauren R. Williamson ◽  
Sarah E. Martin ◽  
Mia DeMarco ◽  
Marta Majczak ◽  
...  

2020 ◽  
Vol 102-B (9) ◽  
pp. 1146-1150
Author(s):  
Alistair I. W. Mayne ◽  
Roslyn S. Cassidy ◽  
Paul Magill ◽  
Owen J. Diamond ◽  
David E. Beverland

Aims Previous research has demonstrated increased early complication rates following total hip arthroplasty (THA) in obese patients, as defined by body mass index (BMI). Subcutaneous fat depth (FD) has been shown to be an independent risk factor for wound infection in cervical and lumbar spine surgery, as well as after abdominal laparotomy. The aim of this study was to investigate whether increased peritrochanteric FD was associated with an increased risk of complications in the first year following THA. Methods We analyzed prospectively collected data on a consecutive series of 1,220 primary THAs from June 2013 until May 2018. The vertical soft tissue depth from the most prominent part of the greater trochanter to the skin was measured intraoperatively using a sterile ruler and recorded to the nearest millimetre. BMI was calculated at the patient’s preoperative assessment. All surgical complications occuring within the initial 12 months of follow-up were identified. Results Females had a significantly greater FD at the greater trochanter in comparison to males (median 3.0 cm (interquartile range (IQR) 2.3 to 4.0) vs 2.0 cm (IQR 1.7 to 3.0); p < 0.001) despite equivalent BMI between sexes (male median BMI 30.0 kg/m2 (IQR 27.0 to 33.0); female median 29.0 kg/m2 (IQR 25.0 to 33.0)). FD showed a weak correlation with BMI (R² 0.41 males and R² 0.43 females). Patients with the greatest FD (upper quartile) were at no greater risk of complications compared with patients with the lowest FD (lower quartile); 7/311 (2.3%) vs 9/439 (2.1%); p = 0.820 . Conversely, patients with the highest BMI (≥ 40 kg/m2) had a significantly increased risk of complications compared with patients with lower BMI (< 40 kg/m2); 5/60 (8.3% vs 18/1,160 (1.6%), odds ratio (OR) 5.77 (95% confidence interval (CI) 2.1 to 16.1; p = 0.001)). Conclusion We found no relationship between peritrochanteric FD and the risk of surgical complications following primary THA. Cite this article: Bone Joint J 2020;102-B(9):1146–1150.


2020 ◽  
pp. 112070002098157
Author(s):  
Lindsey C McVey ◽  
Nicholas Kane ◽  
Helen Murray ◽  
RM Dominic Meek ◽  
S Faisal Ahmed

Background and Aims: Diabetes mellitus (DM), poor glycaemic control and raised body mass index (BMI) have been associated with postoperative complications in arthroplasty, although the relative importance of these factors is unclear. We describe the prevalence of DM in elective hip arthroplasty in a UK centre, and evaluate the impact of these factors. Methods: We analysed retrospective data for DM patients undergoing arthroplasty over a 6-year period and compared with non-diabetic matched controls (1 DM patient: 5 controls). DM was present in 5.7% of hip arthroplasty patients (82/1443). Results: Postoperative complications occurred in 12.2% of DM patients versus 12.9% of controls ( p = 1.000); surgical complications were present in 6.1% of those with DM and 2.4% of controls ( p = 0.087), while medical complications occurred in 8.5% of DM patients versus 10.7% of controls ( p = 0.692). Complications developed in 23.1% of DM patients with poor glycaemic control (HbA1c > 53 mmol/mol) versus 9.8% with good control ( p = 0.169). In DM patients and controls combined, complications occurred in 16.3% of obese patients versus 10.0% of non-obese patients ( p = 0.043). In the DM cohort, 13.7% of overweight patients had complications versus 0% with a normal or low BMI ( p = 0.587). Conclusions: DM rates were lower than expected, and glycaemic control was good. Overall complication rates were unrelated to the presence of DM or to glycaemic control, although surgical complications were observed more frequently in those with DM and poor glycaemic control was uncommon within our cohort. Complications were more frequent in those with a higher BMI. Whether some patients with DM but without an increased risk of complications are currently being excluded from surgery requires exploration.


2019 ◽  
Vol 33 (03) ◽  
pp. 228-234 ◽  
Author(s):  
Alex Gu ◽  
Chapman Wei ◽  
Hannah N. Robinson ◽  
Shane A. Sobrio ◽  
Jiabin Liu ◽  
...  

AbstractTotal knee arthroplasty (TKA) is a common and effective treatment of knee osteoarthritis. As the amount of TKAs performed increases, so does the number of TKA failures and subsequent revisions. Diabetes mellitus (DM) has been shown to increase complications following orthopaedic procedures. For these reasons, it is important to understand the association between severity of DM and the risk of postoperative adverse events following revision TKA. A retrospective cohort study was conducted using the American College of Surgeons' National Surgical Quality Improvement Program database. Patients who underwent revision TKAs between 2007 and 2016 were identified and recorded as having noninsulin-dependent DM (NIDDM), insulin-dependent DM (IDDM), or no DM. Univariate and multivariate analysis were used to evaluate the incidence of multiple adverse events within 30 days after revision TKA. A total of 13,246 patients who underwent revision TKA were selected (without DM = 10,381 [78.4%]; NIDDM = 1,890 [14.3%]; IDDM = 975 [7.4%]). Patients with NIDDM were found to have an increased risk of developing renal insufficiency and urinary tract infection (UTI) compared with patients without DM, while patients with IDDM were found to have an increased risk of developing 10 of 20 adverse events compared with patients without DM. NIDDM is an independent risk factor for UTI and IDDM is an independent factor for development of three complications compared with no DM. Insulin dependency is an independent factor for septic shock, postoperative blood transfusion, and extended postoperative hospital stay. Relative to patients with NIDDM, those with IDDM have a greater likelihood of developing more adverse perioperative outcomes than patients without DM. Although complication rates remain relatively low, orthopaedic surgeons must consider the implications of diabetes and insulin dependence on patient selection, preoperative risk stratification, and postoperative outcomes.


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