External trigeminal nerve stimulation (ETNS) is an emergent, non-invasive neurostimulation therapy delivered bilaterally with adhesive skin electrodes. In previous studies, ETNS was associated to a ...decrease in seizure frequency in patients with focal drug-resistant epilepsy (DRE).
To determine the long-term efficacy and tolerability of ETNS in patients with focal DRE. Moreover, to explore whether its efficacy depends on the epileptogenic zone (frontal or temporal), and its impact on mood, cognitive function, quality of life, and trigeminal nerve excitability.
Forty consecutive patients with frontal or temporal DRE, unsuitable for surgery, were randomized to ETNS or usual medical treatment. Participants were evaluated at 3, 6 and 12 months for efficacy, side effects, mood scales, neuropsychological tests and trigeminal nerve excitability.
Subjects had a median of 15 seizures per month and had tried a median of 12.5 antiepileptic drugs. At 12 months, percentage of responders was 50% in ETNS group and 0% in control group. Seizure frequency in ETNS group decreased by −43.5% from baseline. Temporal epilepsy subgroup responded better than frontal epilepsy subgroup (55.56% vs. 45.45%, respectively). Median stimulation intensity was 6.2 mA. ETNS improved quality of life, but not anxiety or depression. Long-term ETNS affected neither neuropsychological function, nor trigeminal nerve excitability. No relevant adverse events were observed.
ETNS is an effective and well-tolerated therapy for focal DRE. Patients with temporal epilepsy showed a better response than those with frontal epilepsy. Future studies with larger populations may define its role compared to other neurostimulation techniques.
This study provides Class II evidence that ETNS reduces seizure frequency in patients with focal DRE.
•External trigeminal nerve stimulation (ETNS) is effective to treat focal DRE.•Percentage of responders at 12 months was 50% in ETNS group.•Temporal epilepsy responded better than frontal epilepsy (55.56% vs. 45.45%).•ETNS was non-invasive, safe, well tolerated, and improved quality of life.•The role of ETNS compared to other neurostimulation techniques is still undefined.
(1) OBJECTIVE: To assess the performance of CA125, HE4, ROMA index and CPH-I index to preoperatively identify epithelial ovarian cancer (EOC) or metastatic cancer in the ovary (MCO). (2) METHODS: ...single center retrospective study, including women with a diagnosis of adnexal mass. We obtained the AUC, sensitivity, specificity and predictive values were of HE4, CA125, ROMA and CPH-I for the diagnosis of EOC and MCO. Subgroup analysis for women harboring adnexal masses with inconclusive diagnosis of malignancy by ultrasound features and Stage I EOC was performed. (3) RESULTS: 1071 patients were included, 852 (79.6%) presented benign/borderline tumors and 219 (20.4%) presented EOC/MCO. AUC for HE4 was higher than for CA125 (0.91 vs. 0.87). No differences were seen between AUC of ROMA and CPH-I, but they were both higher than HE4 AUC. None of the tumor markers alone achieved a sensitivity of 90%; HE4 was highly specific (93.5%). ROMA showed a sensitivity and specificity of 91.1% and 84.6% respectively, while CPH-I showed a sensitivity of 91.1% with 79.2% specificity. For patients with inconclusive diagnosis of malignancy by ultrasound features and with Stage I EOC, ROMA showed the best diagnostic performance (4) CONCLUSIONS: ROMA and CPH-I perform better than tumor markers alone to identify patients harboring EOC or MCO. They can be helpful to assess the risk of malignancy of adnexal masses, especially in cases where ultrasonographic diagnosis is challenging (stage I EOC, inconclusive diagnosis of malignancy by ultrasound features).
Abstract Objective Researchers in public health are often interested in examining the effect of several exposures on the incidence of a recurrent event. The aim of the present study is to assess how ...well the common-baseline hazard models perform to estimate the effect of multiple exposures on the hazard of presenting an episode of a recurrent event, in presence of event dependence and when the history of prior-episodes is unknown or is not taken into account. Methods Through a comprehensive simulation study, using specific-baseline hazard models as the reference, we evaluate the performance of common-baseline hazard models by means of several criteria: bias, mean squared error, coverage, confidence intervals mean length and compliance with the assumption of proportional hazards. Results Results indicate that the bias worsen as event dependence increases, leading to a considerable overestimation of the exposure effect; coverage levels and compliance with the proportional hazards assumption are low or extremely low, worsening with increasing event dependence, effects to be estimated, and sample sizes. Conclusions Common-baseline hazard models cannot be recommended when we analyse recurrent events in the presence of event dependence. It is important to have access to the history of prior-episodes per subject, it can permit to obtain better estimations of the effects of the exposures
Objective
To evaluate the safety of a minimum continuous positive airway pressure of 4 cmH
2
O (CPAP + 4) during computed tomography (CT)-guided radiofrequency ablation (RFA) for lung malignancies ...under procedural sedation and analgesia (PSA).
Methods
This was a prospective, randomised, single-blind, parallel-group, placebo-controlled trial with an open-label medical device conducted at a single tertiary university hospital in Barcelona, Spain. Forty-six patients over 18 years of age scheduled for CT-guided RFA of a malignant pulmonary tumour under PSA were randomised to receive either CPAP + 4 or a modified mask for placebo CPAP (Sham-CPAP). Exclusion criteria included contraindications for RFA, refusal to participate, inability to understand the procedure or tolerate the CPAP test, lung biopsy just prior to RFA, intercurrent diseases, or previous randomisation for additional pulmonary RFA. Primary outcomes were the percentage of patients reporting at least one serious adverse event (SAE), classification for complications from the Cardiovascular and Interventional Radiological Society of Europe (CIRSE), and Clavien-Dindo classifications for complications, hospital stay, and readmissions. Secondary outcomes included adverse events (AEs), respiratory parameters, airway management, and the local radiological efficacy of pulmonary ablation.
Results
CPAP + 4 prolonged hospital stay (1.5 ± 1.1 vs. 1.0 ± 0 inpatient nights,
p
= 0.022) and increased the risk of AE post-RFA (odds ratio (95% CI): 4.250 (1.234 to 14.637),
p
= 0.021 with more pneumothorax cases (
n
= 5/22, 22.7% vs.
n
= 0/24, 0%,
p
= 0.019). Per-protocol analysis revealed more SAEs and CIRSE grade 3 complications in the CPAP + 4 group (23.5% vs. 0%,
p
= 0.036). No significant differences were found in the effectiveness of oxygenation, ventilation, or pulmonary ablation.
Conclusion
CPAP is unsafe during CT-guided RFA for lung cancer under PSA even at the lowest pressure setting.
Trial registration
ClinicalTrials.Gov, ClinicalTrials.gov ID NCT02117908, Registered 11 April 2014,
https://www.clinicaltrials.gov/study/NCT02117908
Critical relevance statement
This study highlights the hazards of continuous positive airway pressure during radiofrequency ablation of lung cancer, even at minimal pressures, deeming it unsafe under procedural sedation and analgesia in pulmonary interventional procedures. Findings provide crucial insights to prioritise patient safety.
Key Points
No prior randomised controlled trials on CPAP safety in percutaneous lung thermo-ablation.
Standardised outcome measures are crucial for radiology research.
CPAP during lung RFA raises hospital stay and the risk of complications.
CPAP is unsafe during CT-guided RFA of lung cancer under procedural sedoanalgesia.
Graphical Abstract
Compared with drugs plus endoscopy, placement of transjugular portosystemic shunt within 72 hours of admission to the hospital (early or preventive transjugular intrahepatic portosystemic shunt TIPS, ...also called preemptive TIPS) increases the proportion of high-risk patients with cirrhosis and acute variceal bleeding who survive for 1 year. However, the benefit of preemptive TIPS is less clear for patients with a Child-Pugh score of B and active bleeding (CP-B+AB). We performed an individual data meta-analysis to assess the efficacy of preemptive TIPS in these patients and identify factors associated with reduced survival of patients receiving preemptive TIPS.
We searched publication databases for randomized controlled trials and observational studies comparing the effects of preemptive TIPS versus endoscopy plus nonselective beta-blockers in the specific population of high-risk patients with cirrhosis and acute variceal bleeding (CP-B+AB or Child-Pugh C, below 14 points), through December 31, 2019. We performed a meta-analysis of data from 7 studies (3 randomized controlled trials and 4 observational studies), comprising 1327 patients (310 received preemptive TIPS and 1017 received drugs plus endoscopy). We built adjusted models to evaluate risk using propensity score for baseline covariates. Multivariate Cox regression models were used to assess the factors associated with survival time. The primary endpoint was effects of preemptive TIPS versus drugs plus endoscopy on 1-year survival in the overall population as well as CP-B+AB and Child-Pugh C patients.
Overall, preemptive TIPS significantly increased the proportion of high-risk patients with cirrhosis and acute variceal bleeding who survived for 1 year, compared with drugs plus endoscopy (hazard ratio HR 0.443; 95% CI 0.323–0.607; P < .001). This effect was observed in CP-B+AB patients (HR 0.524; 95% CI 0.307–0.896; P = .018) and in patients with Child-Pugh C scores below 14 points (HR 0.374; 95% CI 0.253–0.553; P < .001). Preemptive TIPS significantly improved control of bleeding and ascites without increasing risk of hepatic encephalopathy in Child-Pugh C and CP-B+AB patients, compared with drugs plus endoscopy. Cox analysis of patients who received preemptive TIPS showed that patients could be classified into 3 categories for risk of death, based on age, serum level of creatinine, and Child-Pugh score. In each of these risk categories, preemptive TIPS increased the proportion of patients who survived for 1 year, compared with drugs plus endoscopy.
In a meta-analysis of data from 1327 patients with cirrhosis, acute variceal bleeding, and Child-Pugh score between 10 and 13 points or CP-B+AB, preemptive TIPS increased the proportion who survived for 1 year, in both subgroups separately, compared with drugs plus endoscopy.
A pre-emptive transjugular intrahepatic portosystemic shunt (pTIPS) reduces mortality in high-risk patients with cirrhosis (Child-Pugh C/B+active bleeding) with acute variceal bleeding (AVB). ...Real-life studies point out that <15% of patients eligible for pTIPS ultimately undergo transjugular intrahepatic portosystemic shunt (TIPS) due to concerns about hepatic encephalopathy (HE). The outcome of patients undergoing pTIPS with HE is unknown. We aimed to (1) assess the prevalence of HE in patients with AVB; (2) evaluate the outcome of patients presenting HE at admission after pTIPS; and (3) determine if HE at admission is a risk factor for death and post-TIPS HE.
This is an observational study including 2138 patients from 34 centres between October 2011 and May 2015. Placement of pTIPS was based on individual centre policy. Patients were followed up to 1 year, death or liver transplantation.
671 of 2138 patients were considered at high risk, 66 received pTIPS and 605 endoscopic+drug treatment. At admission, HE was significantly more frequent in high-risk than in low-risk patients (39.2% vs 10.6%, p<0.001). In high-risk patients with HE at admission, pTIPS was associated with a lower 1-year mortality than endoscopic+drug (HR 0.374, 95% CI 0.166 to 0.845, p=0.0181). The incidence of HE was not different between patients treated with pTIPS and endoscopic+drug (38.2% vs 38.7%, p=0.9721), even in patients with HE at admission (56.4% vs 58.7%, p=0.4594). Age >56, shock, Model for End-Stage Liver Disease score >15, endoscopic+drug treatment and HE at admission were independent factors of death in high-risk patients.
pTIPS is associated with better survival than endoscopic treatment in high-risk patients with cirrhosis with variceal bleeding displaying HE at admission.
A previous individual patient data meta-analysis (IPD-MA) showed that compared with drugs+endoscopy, the placement of transjugular portosystemic shunt within 72 hours of admission (pre-emptive ...transjugular intrahepatic portosystemic shunt: p-TIPS) increases the survival of high-risk patients (Child-Pugh B+ active bleeding and Child-Pugh C<14 points) with cirrhosis and acute variceal bleeding. However, the previous IPD-MA was not a two-stage meta-analysis, did not consider the potential risk of selection bias of observational studies, and did not include the most recent randomized clinical trial. We performed an updated and revised IPD-MA to reassess the efficacy of p-TIPS, addressing all previous issues.
We included all studies from the previous IPD-MA and searched for other possible eligible publications until September 2022. We performed a two-stage IPD-MA of data from 8 studies (4 randomized clinical trials and 4 observational). In addition, we performed a sensitivity analysis excluding those patients dying up to the first 72 hours after admission in the Drugs+Endoscopy arms of the 4 observational studies. The primary end point was the effects of p-TIPS versus Drugs+Endoscopy on 1-year survival.We identified 1389 patients (342 p-TIPS and 1047 Drugs+Endoscopy). The two-stage IPD-MA showed that p-TIPS significantly reduced the mortality in the overall population (HR=0·43, 95% CI: 0.32-0.60, p <0.001. This effect was observed in both subgroups of patients with Child-Pugh. The sensitivity analysis confirmed the survival benefit of p-TIPS.
The updated two-stage IPD-MA confirms the significant survival advantage of p-TIPS in high-risk patients with cirrhosis and acute variceal bleeding. As a result, we recommend p-TIPS as the preferred first-choice treatment for these patients.
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