Pituitary surgery during Covid-19: a first hand experience and evaluation.

PURPOSE: During the Covid-19 pandemic every hospital has had to change its internal organization. Different institutions have highlighted the risks connected with endoscopic endonasal surgery. The goal of this paper is to illustrate the feasibility of pituitary region surgery during the SARS-CoV-2 pandemic. METHODS: After two negative Covid tests were obtained, three patients with macro GH-secreting tumors, and two patients with micro ACTH-secreting tumors resistant to medical treatment underwent surgery during the pandemic. During the surgery, every patient was treated as if they were positive. RESULTS: Neither operator, nor patient have developed Covid symptoms. The two neurosurgeons performing the operations underwent two Covid swab, which resulted negative. CONCLUSIONS: Pituitary surgery is a high risk non-urgent surgery. However, the method described has so far been effective and is safe for both patients and healthcare providers.

First but not second postoperative day growth hormone assessments as early predictive tests for long-term acromegaly persistence.

PURPOSE: Postoperative assessment of acromegaly activity is typically performed at least 3 months after neurosurgery (NS). Few studies have evaluated the use of early postoperative growth hormone (GH) levels as a test to predict short- and long-term remission of acromegaly. Our objective was to evaluate the diagnostic performance of serum random GH on a postoperative day one (D1-rGH) and two (D2-rGH), particularly in predicting long-term disease persistence. MATERIALS AND METHODS: Forty-one subjects with acromegaly who were undergoing NS were enrolled (mean age ± SD 47.4 ± 13.1 years at diagnosis; women 54%; macroadenomas 71%). The final assessment of disease activity was performed one year after NS. ROC curves were used to evaluate the diagnostic performance of D1-rGH and D2-rGH. RESULTS: After a 1-year follow-up, the overall remission rate was 55%. ROC analysis identified an optimal D1-rGH cut-off value of 2.1 ng/mL for diagnosing long-term disease persistence (55.6% SE; 90.9% SP). The cut-off point became 2.5 ng/mL after maximizing specificity for disease persistence (yielding a 100% positive predictive value) and 0.3 ng/mL after maximizing sensitivity for disease remission. The optimal D2-rGH cut-off value was 0.6 ng/mL (81.8% SE; 50% SP); the cut-off point became 2.9 ng/mL after maximizing specificity and 0.1 ng/mL after maximizing sensitivity, with no clinical utility. CONCLUSIONS: D1-rGH could be a highly specific test for the early diagnosis of long-term acromegaly persistence, which is predicted by a value > 2.5 ng/mL with a great degree of certainty. The diagnostic performance of D2-rGH was insufficient. Further research is required to validate these preliminary results prior to modifying the postoperative management of acromegaly.

COVID-19 conversations: A qualitative study of majority Hispanic/Latinx youth experiences during early stages of the pandemic.

Background: Growing evidence informs about the detrimental impact that COVID-19 has had on youths' mental health and well-being. As of yet, no study has directly examined the experiences and perspectives of children and young adolescents from racial and ethnic minority groups in the U.S., despite being exposed to more adversity, which may affect coping with the many challenges posed by the pandemic. Objective: This study aimed to give voice to a mostly Hispanic/Latinx group of youth regarding the impact of COVID-19 stay-at-home measures and to identify their emotional responses and coping strategies amid the pandemic in the U.S. when restrictions were at their hardest. Method: A total of 17 youths (70.6 % Hispanic; age range = 10-14 years; 52.9 % female) participated in four virtual semi-structured focus groups for each grade level (grades 5-8). Data was transcribed and analyzed using a gold standard thematic analysis approach. Results: Seven themes were identified concerning the impact of COVID-19, centering around the impact of racism, loss of income, the role of community and family in coping with stress, information overload, home-schooling, loneliness and boredom, and lack of structured routines. Conclusions: Our findings suggest that cultural factors (e.g., collectivism and familism) in Hispanic communities may offer important buffering during COVID-19. Future research studies evaluating the implementation of structured programs that provide a space to talk about emotions and thoughts related to the impact of the pandemic and training in strategies to cope with distress during mandatory home-schooling are needed.

Evaluate the safety and efficacy of dura sealant patch in reducing cerebrospinal fluid leakage following elective cranial surgery (ENCASE II): study protocol for a randomized, two-arm, multicenter trial.

BACKGROUND: Cerebrospinal fluid (CSF) leakage is a frequent and challenging complication in neurosurgery, especially in the posterior fossa, with a prevalence of 8%. It is associated with substantial morbidity and increased healthcare costs. A novel dural sealant patch (LIQOSEAL) was developed for watertight dural closure. The objective of this study is to clinically assess the safety and effectiveness of LIQOSEAL as a means of reducing intra- as well as postoperative CSF leakage in patients undergoing elective posterior fossa intradural surgery with a dural closure procedure compared to the best currently available dural sealants. METHODS: We will conduct a two-arm, randomized controlled, multicenter study with a 90-day follow-up. A total of 228 patients will be enrolled in 19 sites, of which 114 will receive LIQOSEAL and 114 an FDA-approved PEG sealant. The composite primary endpoint is defined as intraoperative CSF leakage at PEEP 20 cm H2O, percutaneous CSF leakage within 90 days of, wound infection within 90 days of or pseudomeningocele of more than 20cc on MRI or requiring intervention. We hypothesize that the primary endpoint will not be reached by more than 10 patients (9%) in the investigational arm, which will demonstrate non-inferiority of LIQOSEAL compared to control. DISCUSSION: This trial will evaluate whether LIQOSEAL is non-inferior to control as a means of reducing CSF leakage and safety TRIAL REGISTRATION: ClinicalTrials.gov NCT04086550 . Registered on 11 September 2019.

Early changes in hepatitis C virus (HCV) RNA levels predict response to interferon treatment in noncirrhotic HCV patients.

UNLABELLED: The role of hepatitis C virus (HCV) RNA quantification in determining ideal interferon (IFN) treatment of noncirrhotic HCV liver disease is uncertain. The specific aim of this study was to determine whether measurement of baseline HCV RNA or changes in HCV RNA levels (DHCV RNA) early during therapy predict response to IFN alpha in noncirrhotic HCV patients. PATIENTS AND METHODS: Twenty-one noncirrhotic patients with chronic HCV were treated with 3 MU IFN alpha-2a three times per week. HCV RNA levels were determined at baseline and after two, four, six, eight and 12 weeks of treatment. Baseline HCV RNA and DHCV RNA during therapy were compared with treatment response results at six months. Data were expressed as mean +/- SE, and differences were assessed using Student's t test. RESULTS: Twenty-one patients initiated IFN alpha therapy. Two patients were noncompliant and lost to follow-up. One patient discontinued IFN alpha due to side effects. Apart from age, where responders tended to be younger than nonresponders, the baseline clinical characteristics and alanine aminotransferase (ALT), aspartate aminotransferase, bilirubin and HCV RNA levels did not differ between IFN alpha responders and nonresponders. Levels of HCV RNA were significantly lower after both two and four weeks of therapy in IFN alpha responders compared with nonresponders (P<0.001). Changes in log HCV RNA levels after both two and four weeks of therapy were significantly greater in IFN alpha responders compared with nonresponders (P<0.001). Changes in log HCV RNA of more than 1.0 after two weeks of IFN alpha therapy identified all six-month responders, with a sensitivity of 100% and a specificity of 89%. Potential financial impact of these findings on patients' management was also calculated. Decisions regarding discontinuation of therapy based on early changes in HCV RNA levels would result in a 40% to 50% reduction in IFN alpha cost. CONCLUSIONS: In noncirrhotic HCV patients, the change in quantitative HCV RNA after the first two weeks of IFN alpha therapy identifies responders. This finding would result in a 40% to 50% cost savings if decisions about continuing IFN alpha were based on early changes in HCV RNA levels rather than ALT or HCV RNA assessment after the completion of three months of IFN alpha treatment.