Barrett's esophagus (BE) is a common condition associated with chronic gastroesophageal reflux disease. BE is the only known precursor to esophageal adenocarcinoma, a highly lethal cancer with an increasing incidence over the last 5 decades. These revised guidelines implement Grading of Recommendations, Assessment, Development, and Evaluation methodology to propose recommendations for the definition and diagnosis of BE, screening for BE and esophageal adenocarcinoma, surveillance of patients with known BE, and the medical and endoscopic treatment of BE and its associated early neoplasia. Important changes since the previous iteration of this guideline include a broadening of acceptable screening modalities for BE to include nonendoscopic methods, liberalized intervals for surveillance of short-segment BE, and volume criteria for endoscopic therapy centers for BE. We recommend endoscopic eradication therapy for patients with BE and high-grade dysplasia and those with BE and low-grade dysplasia. We propose structured surveillance intervals for patients with dysplastic BE after successful ablation based on the baseline degree of dysplasia. We could not make recommendations regarding chemoprevention or use of biomarkers in routine practice due to insufficient data.
Product characteristics should be reported in all biological therapy publications
The COVID-19 pandemic has become an unprecedented facilitator of rapid telehealth expansion within rheumatology. Due to demographic shifts and workforce shortages in the future, new models of rheumatology care will be expected to emerge, with a growing footprint of telehealth interventions. Telehealth is already being used to monitor patients with rheumatic diseases and initial studies show good results in terms of safety and disease progression. It is being used as a tool for appointment prioritization and triage, and there is good evidence for using telehealth in rehabilitation, patient education and self-management interventions. Electronic patient-reported outcomes (ePROs) offer a number of long-term benefits and opportunities, and a routine collection of ePROs also facilitates epidemiological research that can inform future healthcare delivery. Telehealth solutions should be developed in close collaboration with all stakeholders, and the option of a telehealth visit must not deprive patients of the possibility to make use of a conventional ‘face-to-face’ visit. Future studies should especially focus on optimal models for rheumatology healthcare delivery to patients living in remote areas who are unable to use or access computer technology, and other patient groups at risk for disparity due to technical inequity and lack of knowledge.
SMARCB1 and RB1 Gene: Novel Mutations in Neuroendocrine Tumors of Sinonasal Cavity
Retrospective Review of Surgical Site Infections after Endoscopic Endonasal Approaches for Parasellar Masses: A Multicenter Study from the North American Skull Base Society
The Burden of Coronavirus Disease 2019–Related Cases, Hospitalizations, and Mortality Based on Vaccination Status and Mandated Mask Use: Statewide Data From Wisconsin and Narrative Review of the Literature
BACKGROUND: Coronavirus disease 2019 (COVID-19) cases continue to surge in the United States with the emergence of new variants. Statewide variability and inconsistency in implementing risk mitigation strategies are widespread, particularly in regards to enforcing mask mandates and encouraging the public to become fully vaccinated. METHODS: This is a cross-sectional study conducted on July 31, 2021, utilizing publicly available data from the Wisconsin Department of Health Services. The authors abstracted data on total COVID-19–related cases, hospitalizations, and deaths in the state of Wisconsin. The primary objective was comparison of total COVID-19–related cases, hospitalizations, and deaths in vaccinated versus unvaccinated people in the state of Wisconsin over a 31-day period (July 2021). Furthermore, we also performed a narrative review of the literature on COVID-19–related outcomes based on mask use and vaccination status. RESULTS: In the state of Wisconsin during July 2021, total COVID-19 cases was 125.4 per 100,000 fully vaccinated people versus 369.2 per 100,000 not fully vaccinated people (odds ratio [OR] = 0.34, 95% confidence interval [CI], 0.33–0.35; P < .001). Total COVID-19 hospitalizations was 4.9 per 100,000 fully vaccinated people versus 18.2 per 100,000 not fully vaccinated people (OR = 0.27, 98% CI, 0.22–0.32; P < .001). Total COVID-19 deaths was 0.1 per 100,000 fully vaccinated people versus 1.1 per 100,000 not fully vaccinated people (OR = 0.09, 95% CI, 0.03–0.29; P < .001). Narrative review of the literature demonstrated high vaccine effectiveness against COVID-19 infection prevention (79%–100% among fully vaccinated people), COVID-19–related hospitalization (87%–98% among fully vaccinated people), and COVID-19–related death (96.7%–98% among fully vaccinated people). Studies have also generally reported that mask use was associated with increased effectiveness in preventing COVID-19 infection ≤70%. CONCLUSIONS: Strict adherence to public mask use and fully vaccinated status are associated with improved COVID-19–related outcomes and can mitigate the spread, morbidity, and mortality of COVID-19. Anesthesiologists and intensivists should adhere to evidence-based guidelines in their approach and management of patients to help mitigate spread.
Adverse Events Associated With 10-kHz Dorsal Column Spinal Cord Stimulation
Background: High-frequency (10-kHz) spinal cord stimulation (SCS) continues to be an emerging therapy in chronic pain management. The same complications that plagued earlier SCS systems may affect newer stimulation technologies, although there is limited data on the type of complications and surgical management of these complications. Objective: The aim of this study was to systematically examine real-world complications associated with 10-kHz SCS reported on the Manufacturer and User Facility Device Experience (MAUDE) database. Materials and Methods: The MAUDE database was queried for entries reported between January 1, 2016 and December 31, 2020. Entries were classified into procedural complications, device-related complications, patient complaints, surgically managed complications, serious adverse events, and/or other complications. Primary outcomes included type and frequency of complications, and surgical management of complications. Results: A total of 1651 entries were analyzed. Most entries were categorized as procedural complications (72.6%), followed by serious adverse events (10.5%), device-related complications (10.5%), and patient complaints (9.9%). Most complications were managed surgically with explant (50.9%) rather than revision (5.0%) or incision/drainage (6.6%). Of procedural complications, the most common entries included non-neuraxial infection (52.9%), new neurological symptoms (14.7%), and dural puncture (9.5%). Of device-related complications, the most common entries included lead damage (41.6%), erosion (18.5%), and difficult insertion (11.5%). Conclusion: This retrospective 5-year analysis of complications from10-kHz SCS provides a real-world assessment of safety data unique for this stimulation modality. This analysis may help inform future clinical decisions, lead to device enhancement and optimization, and improve mitigation of risks to provide safe and efficacious use of 10-kHz SCS.
Peripheral Nerve Stimulation: The Evolution in Pain Medicine
Efficacy and Long-Term Outcomes of Autologous Stem Cell Transplant (ASCT) for Patients with POEMS Syndrome (Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal Protein, Skin Changes): A CIBMTR Analysis
Abstract Introduction POEMS syndrome is a rare disease associated with a plasma cell dyscrasia with limited information regarding the role of ASCT. Small single institution series have demonstrated deep and durable responses after ASCT along with neurological improvement. Despite these benefits, ASCT is thought to have higher treatment related morbidity and mortality, limiting its use. We describe the outcomes from an international multicenter database of patients with POEMS syndrome undergoing ASCT. Methods We performed a retrospective analysis using the Center for International Blood and Marrow Transplant Research (CIBMTR) database to evaluate the outcomes of patients undergoing ASCT for POEMS syndrome. Standard descriptive methods were used to report patient characteristics. Univariate and multivariate analysis were performed to identify predicators for non-relapse mortality (NRM), relapse, progression-free and overall survival (PFS, OS). NRM was compared between POEMS and multiple myeloma (MM) patients who underwent ASCT during the same time period. Results Between 2008-2018, 331 pts with POEMS syndrome who underwent ASCT were identified. The median age was 51 years, with 66% males. Racial distribution was 65% Caucasians, 19% African American, 5% other, and 10% missing. Pre-transplant characteristics included 70% patients had Karnofsky score <90, and 50% had HCT-CI ≥ 3, reflecting underlying disease severity and symptoms. The most common comorbidity was pulmonary (52%). Only 14% of patients were in very good partial response or better at the time of ASCT and 72 (22%) patients underwent ASCT without prior treatment. The median time from diagnosis to ASCT was 7 months and 74% underwent ASCT within 12 months of diagnosis. The most common mobilization strategy was GCSF +/- plerixafor in 50% of pts and 87% of pts received conditioning with 200mg/m2 of Melphalan. The median follow up was 48 (range 3-137) months. At day 100, NRM was 0.9 % (95% CI: 0.2-2.2%). At 4 years, NRM was 4.9% (95% CI: 2.6-7.9%), relapse 15.4% (95% CI 11.3-20.1%), PFS 79.7% (95% CI 74.5-84.3%) and OS 92% (95% CI 89.2-95.6%). Subsequent neoplasms were seen in 16 (5%) with 4 myeloid malignancy and 12 solid tumors. On multivariate analysis, age ≥ 60 years was associated with greater hazards of mortality, HR 2.6 (95% CI 1.2-5.6), p 0.01. The figure shows the comparable NRM between POEMS and MM (p 0.31). Conclusions: We report outcomes of the largest ASCT series of POEMS patients. Despite a high HCT-CI and low functional status among patients with POEMS syndrome, no difference in NRM was seen when compared to MM. Post-transplant outcomes were excellent and support single center data on the role of ASCT in this rare disease. Figure 1 Figure 1. Disclosures Kansagra: Oncopeptides: Membership on an entity's Board of Directors or advisory committees; Takeda: Membership on an entity's Board of Directors or advisory committees; Janssen: Membership on an entity's Board of Directors or advisory committees; Sanofi: Membership on an entity's Board of Directors or advisory committees; BMS: Membership on an entity's Board of Directors or advisory committees; Alynylam: Membership on an entity's Board of Directors or advisory committees; Cota Health: Membership on an entity's Board of Directors or advisory committees; GSK: Membership on an entity's Board of Directors or advisory committees; Karyopharm: Membership on an entity's Board of Directors or advisory committees; Pharmacyclics: Membership on an entity's Board of Directors or advisory committees; Pfizer: Membership on an entity's Board of Directors or advisory committees. Dispenzieri: Alnylam: Research Funding; Pfizer: Research Funding; Sorrento Therapeutics: Consultancy; Takeda: Research Funding; Oncopeptides: Consultancy; Janssen: Consultancy, Research Funding. Kumar: Abbvie: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Merck: Research Funding; BMS: Consultancy, Research Funding; Oncopeptides: Consultancy; Beigene: Consultancy; KITE: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Roche-Genentech: Consultancy, Research Funding; Astra-Zeneca: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Antengene: Consultancy, Honoraria; Novartis: Research Funding; Bluebird Bio: Consultancy; Celgene: Membership on an entity's Board of Directors or advisory committees, Research Funding; Amgen: Consultancy, Research Funding; Carsgen: Research Funding; Janssen: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Tenebio: Research Funding; Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Adaptive: Membership on an entity's Board of Directors or advisory committees, Research Funding; Sanofi: Research Funding. Qazilbash: Bristol-Myers Squibb: Other: Advisory Board; NexImmune: Research Funding; Janssen: Research Funding; Biolline: Research Funding; Oncopeptides: Other: Advisory Board; Angiocrine: Research Funding; Amgen: Research Funding. Shah: GSK: Consultancy; Karyopharm: Consultancy; Oncopeptides: Consultancy; Indapta Therapeutics: Consultancy; Janssen: Research Funding; Nektar: Research Funding; Bluebird Bio: Research Funding; Teneobio: Research Funding; CareDx: Consultancy; BMS/Celgene: Research Funding; Sanofi: Consultancy; Sutro Biopharma: Research Funding; CSL Behring: Consultancy; Poseida: Research Funding; Precision Biosciences: Research Funding; Amgen: Consultancy; Kite: Consultancy. D'Souza: Sanofi, Takeda, Teneobio, CAELUM, Prothena: Research Funding; Imbrium, Pfizer, BMS: Membership on an entity's Board of Directors or advisory committees; Janssen, Prothena: Consultancy.