Comparison of Cost and Efficacy of Trufill® vs Histoacryl® n-Butyl Cyanoacrylate for Translumbar Type 2 Endoleak Embolization

2020 ◽  
pp. 153857442097382
Author(s):  
George Raymond Wong ◽  
Hyeon Yu ◽  
Ari J. Isaacson

Purpose: The study aimed to compare the cost and efficacy of translumbar approach type 2 endoleak repairs using either Trufill® or Histoacryl® n-BCA liquid embolic. Method and Materials: This was a retrospective review of patients who had translumbar approach type 2 endoleak repairs using either Trufill® or Histoacryl®. Patients were included if they underwent a technically successful type 2 endoleak repair via a translumbar approach with Trufill® or Histoacryl® n-BCA. A multivariable analysis was performed with the primary clinical outcome of percent change in aneurysm diameter per month compared. Procedure cost was calculated based on typical materials used. Results: 20 Trufill® and 14 Histoacryl® patients were included. The mean procedure cost was higher for Trufill® ($5,757.30 vs. $1,586.09, p ≤ 0.001). There was no significant difference between Trufill® or Histoacryl® patients for age at first embolization, gender, total number of embolizations, number of feeding branches, aneurysm sac size prior to embolization, or residual endoleak at first follow-up. Trufill® patients had more coils used (12.0 vs. 4.3, p = 0.0007), less glue used (0.9 vs. 2.1 mL, p < 0.001), longer follow-up duration (33.5 vs. 13.2 months, p = 0.002), more follow-up CT angiograms (CTA) (3.7 vs. 1.9, p = 0.01), and larger excluded aneurysm sac size at most recent CTA (7.1 cm vs. 5.9 cm, p = 0.04). Percent change in sac diameter per month was not significantly different between Trufill® and Histoacryl® (0.21% vs. -0.25%/month, p = 0.06, respectively). There were no complications. Conclusion: Use of Histoacryl® over Trufill® n-BCA resulted in significantly less procedural cost while maintaining safety and efficacy.

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 ◽  
Vol 21 (1) ◽  
Author(s):  
Henderikus E. Boersma ◽  
Robert P. van Waateringe ◽  
Melanie M. van der Klauw ◽  
Reindert Graaff ◽  
Andrew D. Paterson ◽  
...  

Abstract Background Skin autofluorescence (SAF) is a non-invasive marker of tissue accumulation of advanced glycation endproducts (AGE). Recently, we demonstrated in the general population that elevated SAF levels predict the development of type 2 diabetes (T2D), cardiovascular disease (CVD) and mortality. We evaluated whether elevated SAF may predict the development of CVD and mortality in individuals with T2D. Methods We included 2349 people with T2D, available baseline SAF measurements (measured with the AGE reader) and follow-up data from the Lifelines Cohort Study. Of them, 2071 had no clinical CVD at baseline. 60% were already diagnosed with diabetes (median duration 5, IQR 2–9 years), while 40% were detected during the baseline examination by elevated fasting blood glucose ≥7.0 mmol/l) and/or HbA1c ≥6.5% (48 mmol/mol). Results Mean (±SD) age was 57 ± 12 yrs., BMI 30.2 ± 5.4 kg/m2. 11% of participants with known T2D were treated with diet, the others used oral glucose-lowering medication, with or without insulin; 6% was using insulin alone. Participants with known T2D had higher SAF than those with newly-detected T2D (SAF Z-score 0.56 ± 0.99 vs 0.34 ± 0.89 AU, p < 0.001), which reflects a longer duration of hyperglycaemia in the former group. Participants with existing CVD and T2D had the highest SAF Z-score: 0.78 ± 1.25 AU. During a median follow-up of 3.7 yrs., 195 (7.6%) developed an atherosclerotic CVD event, while 137 (5.4%) died. SAF was strongly associated with the combined outcome of a new CVD event or mortality (OR 2.59, 95% CI 2.10–3.20, p < 0.001), as well as incidence of CVD (OR 2.05, 95% CI 1.61–2.61, p < 0.001) and death (OR 2.98, 2.25–3.94, p < 0.001) as a single outcome. In multivariable analysis for the combined endpoint, SAF retained its significance when sex, systolic blood pressure, HbA1c, total cholesterol, eGFR, as well as antihypertensive and statin medication were included. In a similar multivariable model, SAF was independently associated with mortality as a single outcome, but not with incident CVD. Conclusions Measuring SAF can assist in prediction of incident cardiovascular disease and mortality in individuals with T2D. SAF showed a stronger association with future CVD events and mortality than cholesterol or blood pressure levels.


2021 ◽  
pp. 1-9
Author(s):  
Leonard Naymagon ◽  
Douglas Tremblay ◽  
John Mascarenhas

Data supporting the use of etoposide-based therapy in hemophagocytic lymphohistiocytosis (HLH) arise largely from pediatric studies. There is a lack of comparable data among adult patients with secondary HLH. We conducted a retrospective study to assess the impact of etoposide-based therapy on outcomes in adult secondary HLH. The primary outcome was overall survival. The log-rank test was used to compare Kaplan-Meier distributions of time-to-event outcomes. Multivariable Cox proportional hazards modeling was used to estimate adjusted hazard ratios (HRs) with 95% confidence intervals (CIs). Ninety adults with secondary HLH seen between January 1, 2009, and January 6, 2020, were included. Forty-two patients (47%) received etoposide-based therapy, while 48 (53%) received treatment only for their inciting proinflammatory condition. Thirty-three patients in the etoposide group (72%) and 32 in the no-etoposide group (67%) died during follow-up. Median survival in the etoposide and no-etoposide groups was 1.04 and 1.39 months, respectively. There was no significant difference in survival between the etoposide and no-etoposide groups (log-rank <i>p</i> = 0.4146). On multivariable analysis, there was no association between treatment with etoposide and survival (HR for death with etoposide = 1.067, 95% CI: 0.633–1.799, <i>p</i> = 0.8084). Use of etoposide-based therapy was not associated with improvement in outcomes in this large cohort of adult secondary HLH patients.


2020 ◽  
Vol 19 (1) ◽  
Author(s):  
Celestino Sardu ◽  
Pasquale Paolisso ◽  
Valentino Ducceschi ◽  
Matteo Santamaria ◽  
Cosimo Sacra ◽  
...  

Abstract Objectives To evaluate the effects of cardiac resynchronization therapy (CRTd) in patients with type 2 diabetes mellitus (T2DM) optimized via automatic vs. echocardiography-guided approach. Background The suboptimal atrio-ventricular (AV) and inter-ventricular (VV) delays optimization reduces CRTd response. Therefore, we hypothesized that automatic CRTd optimization might improve clinical outcomes in T2DM patients. Methods We designed a prospective, multicenter study to recruit, from October 2016 to June 2019, 191 consecutive failing heart patients with T2DM, and candidate to receive a CRTd. Study outcomes were CRTd responders rate, hospitalizations for heart failure (HF) worsening, cardiac deaths and all cause of deaths in T2DM patients treated with CRTd and randomly optimized via automatic (n 93) vs. echocardiography-guided (n 98) approach at 12 months of follow-up. Results We had a significant difference in the rate of CRTd responders (68 (73.1%) vs. 58 (59.2%), p 0.038), and hospitalizations for HF worsening (12 (16.1%) vs. 22 (22.4%), p 0.030) in automatic vs. echocardiography-guided group of patients. At multivariate Cox regression analysis, the automatic guided approach (3.636 [1.271–10.399], CI 95%, p 0.016) and baseline highest values of atrium pressure (automatic SonR values, 2.863 [1.537–6.231], CI 95%, p 0.006) predicted rate of CRTd responders. In automatic group, we had significant difference in SonR values comparing the rate of CRTd responders vs. non responders (1.24 ± 0.72 g vs. 0.58 ± 0.46 g (follow-up), p 0.001), the rate of hospitalizations for HF worsening events (0.48 ± 0.29 g vs. 1.18 ± 0.43 g, p 0.001), and the rate of cardiac deaths ( 1.13 ± 0.72 g vs. 0.65 ± 0.69 g, p 0.047). Conclusions Automatic optimization increased CRTd responders rate, and reduced hospitalizations for HF worsening. Intriguingly, automatic CRTd and highest baseline values of SonR could be predictive of CRTd responders. Notably, there was a significant difference in SonR values for CRTd responders vs. non responders, and about hospitalizations for HF worsening and cardiac deaths. Clinical trial ClinicalTrials.gov Identifier NCT04547244.


2018 ◽  
Vol 11 (6) ◽  
pp. 507-513 ◽  
Author(s):  
Ercan Şahin ◽  
Mahmut Kalem

Objectives. To evaluate the costs and efficacy of radiographs taken in the third week after fixation of bimalleolar and trimalleolar fractures. Patients and method. A retrospective evaluation was made of patients who underwent surgical fixation because of bimalleolar and trimalleolar fractures between January 1, 2008, and October 1, 2013. Patient demographics (age, gender, body mass index), fracture type, follow-up periods, and fixation methods were recorded, and the radiographs taken on postoperative day 1, at 3 weeks, 6 weeks, and the final follow-up were examined by 2 orthopedists. Measurements were taken of the medial clear space (MCS ≤ 4 mm), the tibiofibular clear space (TFCS < 5 mm), and the talocrural angle (TCA = 83° ± 4°) on the mortise radiograph and of the overlap between the tibial tubercle and fibula (TFO > 10 mm) on the anteroposterior radiograph; residual step (mm) was measured on the lateral radiograph. Results. A total of 263 patients were examined, and of these, 112 were included for evaluation. In the measurements of postoperative day 1, third week, and sixth week and the final radiographs, no statistically significant difference was determined in the MCS, TFCS, TCA, TFO, and residual step values. Because the cost of a series of 3-way ankle radiographs in Turkey is US$3.81 per patient, the cost of the control series for the 112 patients in this study was US$ 427.3. Conclusions. In patients treated surgically for bimalleolar and trimalleolar fractures, the radiographs taken in the third week rarely resulted in a change of patient management. Therefore, it simply constitutes an additional cost for the patient or the hospital. Levels of Evidence: Level III: Retrospective Cohort study


2021 ◽  
Author(s):  
Frank Qian ◽  
Andres V Ardisson Korat ◽  
Fumiaki Imamura ◽  
Matti Marklund ◽  
Nathan Tintle ◽  
...  

<b><i>Objective</i></b><b> </b>Prospective associations between omega-3 fatty acid biomarkers and type 2 diabetes (T2D) risk are not consistent in individual studies. We aimed to summarize prospective associations between biomarkers of alpha-linolenic acid (ALA), eicosapentaenoic acid (EPA), docosapentaenoic acid (DPA), and docosahexaenoic acid (DHA), and T2D risk through an individual participant-level pooled analysis. <p><b><i>Research Design and Methods </i></b>Our analysis incorporated data from a global consortium of 20 prospective studies from 14 countries. We included 65,147 participants who had blood measurements of ALA, EPA, DPA, or DHA and were free of diabetes at baseline.</p> <p><i>De novo</i> harmonized analyses were performed in each cohort following a pre-specified protocol and cohort-specific associations were pooled using inverse variance-weighted meta-analysis.</p> <p><b><i>Results</i></b><b> </b>A total of 16,693 incident T2D cases were identified during follow-up (median follow-up ranging from 2.5 to 21.2 years). In pooled multivariable analysis, per inter-quintile range (difference between the 90<sup>th</sup> and 10<sup>th</sup> percentiles for each fatty acid), EPA, DPA, DHA, and their sum were associated with lower T2D incidence, with hazard ratios (HRs) and 95% confidence intervals (CIs) of 0.92 (0.87, 0.96), 0.79 (0.73, 0.85), 0.82 (0.76, 0.89) and 0.81 (0.75, 0.88), respectively (all <i>P</i><0.001). ALA was not associated with T2D, 0.97 (0.92, 1.02) per inter-quintile range. Associations were robust across pre-specified subgroups as well as in sensitivity analyses. </p> <p><b><i>Conclusions </i></b><a></a><a>Higher circulating biomarkers of seafood-derived omega-3 fatty acids, including EPA, DPA, DHA, and their sum were associated with lower risk of T2D in a global consortium of prospective studies. </a>The biomarker of plant-derived ALA was not significantly associated with T2D risk. </p>


2021 ◽  
Author(s):  
Frank Qian ◽  
Andres V Ardisson Korat ◽  
Fumiaki Imamura ◽  
Matti Marklund ◽  
Nathan Tintle ◽  
...  

<b><i>Objective</i></b><b> </b>Prospective associations between omega-3 fatty acid biomarkers and type 2 diabetes (T2D) risk are not consistent in individual studies. We aimed to summarize prospective associations between biomarkers of alpha-linolenic acid (ALA), eicosapentaenoic acid (EPA), docosapentaenoic acid (DPA), and docosahexaenoic acid (DHA), and T2D risk through an individual participant-level pooled analysis. <p><b><i>Research Design and Methods </i></b>Our analysis incorporated data from a global consortium of 20 prospective studies from 14 countries. We included 65,147 participants who had blood measurements of ALA, EPA, DPA, or DHA and were free of diabetes at baseline.</p> <p><i>De novo</i> harmonized analyses were performed in each cohort following a pre-specified protocol and cohort-specific associations were pooled using inverse variance-weighted meta-analysis.</p> <p><b><i>Results</i></b><b> </b>A total of 16,693 incident T2D cases were identified during follow-up (median follow-up ranging from 2.5 to 21.2 years). In pooled multivariable analysis, per inter-quintile range (difference between the 90<sup>th</sup> and 10<sup>th</sup> percentiles for each fatty acid), EPA, DPA, DHA, and their sum were associated with lower T2D incidence, with hazard ratios (HRs) and 95% confidence intervals (CIs) of 0.92 (0.87, 0.96), 0.79 (0.73, 0.85), 0.82 (0.76, 0.89) and 0.81 (0.75, 0.88), respectively (all <i>P</i><0.001). ALA was not associated with T2D, 0.97 (0.92, 1.02) per inter-quintile range. Associations were robust across pre-specified subgroups as well as in sensitivity analyses. </p> <p><b><i>Conclusions </i></b><a></a><a>Higher circulating biomarkers of seafood-derived omega-3 fatty acids, including EPA, DPA, DHA, and their sum were associated with lower risk of T2D in a global consortium of prospective studies. </a>The biomarker of plant-derived ALA was not significantly associated with T2D risk. </p>


2021 ◽  
Vol 108 (Supplement_2) ◽  
Author(s):  
A Master ◽  
A Saad ◽  
A George ◽  
A Syed ◽  
P Laing ◽  
...  

Abstract Introduction It has been shown that direct fixation of the posterior malleolus improves functional outcomes. Our aim was to audit the functional outcome of patients with these fractures which were fixed with an isolated posterolateral approach. Method A consecutive case series of patients who underwent direct fixation of the posterior malleolus using a posterolateral approach between 20/12/2012 and 23/1/2020 was identified. Fractures were classified according to Mason and Molloy classification based on preoperative CT. Type 2a and 2b fractures were included. Functional outcome was assessed using Olerud-Molander score. Result 18 patients were included. Mean age at time of surgery was 52 years (range 20 to 75 years). 56% (n = 10) were female. Mean follow up was 18.1 months (range 4.2 months to 7.2 years). OMAS score for type 2a fractures (n = 9) was 71.1 (95% CI 65.3 to 77.0). OMAS score for type 2b fractures (n = 9) was 67.8 (95% CI 54.6 to 81.0). There was no significant difference between groups (p = 0.65). Conclusions Fixation of Mason and Molloy Type 2 fractures using an isolated posterolateral approach results in satisfactory functional results for the majority of patients. Further prospective comparative study is needed to identify which patients benefit most from alternative approaches.


Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 849-849 ◽  
Author(s):  
Lynda M. Vrooman ◽  
Donna Neuberg ◽  
Jane O’Brien ◽  
Stephen E. Sallan ◽  
Lewis B. Silverman

Abstract BACKGROUND: Dexamethasone (dex) may be more efficacious but also more toxic than prednisone (pred) in the treatment of childhood ALL. In order to compare the relative toxicities of these 2 steroids, patients (pts) on DFCI ALL Consortium Protocol 00–01 were randomized to receive dex or pred during post-induction therapy. METHODS: Pts received 5-day steroid pulses every 3 weeks for 2 years (yrs) (pred 40mg/m2/day or dex 6 mg/m2/day) beginning at week 7 of therapy. High Risk (HR) pts received 3 times these doses during the Intensification Phase (approximately 6 months). RESULTS: Between 2000–2004, 425 pts (ages 1–18 yrs) were randomized; 423 had evaluable skeletal toxicity data, including 241 Standard Risk (SR) and 182 HR pts. 211 received dex and 212 received pred. Within 26 months of enrollment, 55 pts (13%) experienced at least 1 bony event: 45 pts (11%) with fracture and 17 (4%) with osteonecrosis (ON). Bony events were more common in children ≥10 yrs of age (11% of those <10 yrs vs. 18.5% ≥10 yrs, p=0.007). There was no overall difference in frequency of pts with skeletal toxicity based on steroid type (see table, p=0.89), including no difference in fractures (11% dex vs. 10% pred, p=0.88) or ON (5% dex vs. 3% pred, p=0.23). However, skeletal toxicity was more common in dex-treated older children (≥10 yrs) compared with pred-treated older children (25% vs. 11%, p=0.07) and compared with younger (< 10 yrs) dex-treated pts (25% vs. 9%, p=0.004). There was no difference in frequency of skeletal toxicity by age in pred-treated pts (p=0.31). There was no difference in frequency of skeletal toxicity by steroid type in SR pts (8% dex vs. 14% pred, p=0.22) or in younger HR pts (12% dex vs. 11% pred, p=1.0). In multivariable analysis, children ≥10 yrs treated with dex had 2.7 times the risk of developing skeletal toxicity compared with all other pts (p=0.006). Of 404 pts with evaluable infection data, 37/200 (18.5%) dex-treated pts developed at least 1 infection (bacteremia and/or invasive fungal disease) during intensification or continuation compared to 24/204 (11.8%) pred-treated pts (p=0.07). There was no difference in infection rate by steroid type for those <10 yrs of age (p=0.53). However, for those ≥10 yrs, there were more infections in dex-treated than in pred-treated pts (24% vs. 5%, p=0.01). At 2.8 yrs median follow-up, there was no statistically significant difference in event-free survival (EFS) comparing dex- vs. pred-treated pts (90% vs. 88%, p=0.31), although there was a suggestion of inferior EFS in HR pts randomized to pred. Skeletal Toxicity and Infection: Dexamethasone vs. Prednisone* Dexamethasone Prednisone P value *Depicted are the numbers of pts with at least 1 toxicity event of all pts within particular subgroups. Skeletal Toxicity All 28/211 (13.3%) 27/212 (12.7%) 0.89 Age < 10 yrs 14/160 (9%) 22/166 (13%) 0.21 Age ≥ 10 yrs 13/51 (25%) 5/46 (11%) 0.07 Infection All 37/200 (18.5%) 24/204 (11.8%) 0.07 Age < 10 yrs 26/154 (17%) 22/160 (14%) 0.53 Age ≥ 10 yrs 11/46 (24%) 2/44 (5%) 0.01 CONCLUSION: Dexamethasone was associated with increased risk of skeletal toxicity and infection in pts ≥10 yrs of age. Longer follow-up is needed to fully assess EFS differences between the randomized treatment groups.


2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Lucia Aubert ◽  
Justo Sandino ◽  
Florencio Garcia ◽  
Elena Gutiérrez ◽  
Julian Segura ◽  
...  

Abstract Background and Aims Nowadays, there is growing evidence that non-alcoholic fatty liver disease (NAFLD) may be associated with renal impairment and have an impact on the evolution of renal function in patients with type 2 diabetes mellitus (DM). Our aim was to compare the effect on renal function and proteinuria in patients with type 2 DM according to the presence of NAFLD. Method Retrospective and observational study, including patients with type 2 DM, &lt; 70 years of age and with estimated glomerular filtration rate (eGFR) &gt; 30 ml/min/1,73 m2. NAFLD was defined with the presence of compatible ultrasonography and/or presence of fibrosis using NAFLD score. Metabolic syndrome (MSd) was defined as: obesity (body mass index (BMI) &gt; 30 kg/m2), hypertension and dyslipidaemia. Patients were classified according to the presence or absence of NAFLD. We analysed different clinical and analytical variables along the follow up. Results A total of 71 patients were included (66% males) with mean age of 57.4 ± 7.8 years. The median evolution of type 2 DM was 72.2 months (34.7 - 125.5 months) and 90.1% of the patients were treated with renin-angiotensin blockade. When comparing patients with (group 1, n=38) and without (group 2, n=33) NAFLD at the beginning of this study, we found no significant difference in eGFR (80.2 ± 40.4 ml/min vs 71.4 ± 31.8 ml/min), proteinuria (1.4 ± 2.7 g/24h vs 0.8 ± 1.0 g/24h) and glycated haemoglobin (6.8 ± 1.4% vs 7.2 ± 1.6%). On the other hand, we found significant difference in the presence of higher BMI (33.8 vs 29.3 kg/m2; .001) and presence of MSd (67.7 vs 32.3%; .03) in those patients with NAFLD. After a mean follow-up time of 74 months, we found significant differences in the loss of eFGR (-33.8 vs -13.9 ml/min; .003), but no difference in increase of proteinuria. We found an increase in incidence of chronic kidney disease in group 1 (50%) vs group 2 (10.5%). There were no differences in the need to initiate renal replacement therapy or all-cause mortality. Conclusion NAFLD in type 2 DM caused a mayor decline in renal function. We should, therefore, take into consideration the presence of NALFD and the presence of MSd to optimise treatment of associated risk factors.


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