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Corrigendum to \u27Executive Summary of the 2023 Adult Position Development Conference of the International Society for Clinical Densitometry: DXA Reporting, Follow-up BMD Testing and Trabecular Bone Score Application and Reporting\u27 Journal of Clinical Densitometry Volume 27, Issue 1, January-March 2024, 101435.
No full textIndications and outcomes of the extended endoscopic endonasal approach for the removal of unconventional suprasellar pituitary neuroendocrine tumors.
No full textOBJECTIVE: Pituitary neuroendocrine tumors (PitNETs) rarely harbor unconventional inner features such as wide intracranial extension, fibrous consistency, irregular shape, vessel encasement, and subarachnoid space invasion that increase surgical complexity, as they are not suitable for the standard transsphenoidal route. Among this subset of difficult adenomas, PitNETs harboring an unconventional suprasellar extension present peculiar surgical considerations and challenges. Herein, the authors present an international multicentric study, intending to analyze the indications and outcomes of the endoscopic endonasal transtuberculum-transplanum approach (ETTA) for the removal of these so-called unconventional PitNETs in a large cohort of patients.
METHODS: PitNETs removed via an endoscopic endonasal approach (EEA) between January 2000 and December 2023 at 4 primary referral centers were retrospectively reviewed. Tumors removed via the ETTA and harboring one or more of the following unconventional suprasellar features, regardless of size and/or cavernous sinus invasion, were included in the study: irregular shape, vessel encasement, subarachnoid invasion at the supradiaphragmatic space, and firm or fibrous consistency. Clinical, radiological, surgical findings, and outcomes were reviewed.
RESULTS: Of a total of 5138 patients with PitNETs, 257 patients underwent an ETTA (5%). Nonfunctioning PitNETs were the most common (65.4%). The most common presenting symptoms were visual field restriction (64.6%), decreased visual acuity (51%), anterior pituitary deficiency (44.8%), and endocrine hyperproduction syndromes (20.6%). All PitNETs harbored prominent suprasellar extension: 33.1% were giant and 30.7% were fibrous; the majority were multilobular (43.6%) and Knosp grade ≥ 3 (54.1%). Overall, 51.8% of patients had undergone previous treatment. The gross-total resection (GTR) rate was 49.8%. Visual field and visual acuity improved in 67.5% and 82.4% of cases, respectively. The postoperative complication rate was 19.1%. Previous treatment, vessel encasement, and Knosp grade ≥ 3 were independent risk factors affecting extent of resection. A suprasellar tumor remnant was the only significant risk factor for vascular complications, and tumor GTR the only protecting factor.
CONCLUSIONS: This is the largest series in the literature describing indications and outcome expectations of the ETTA for the removal of unconventional suprasellar PitNETs. Tumor size, shape, and consistency did not represent a limitation to favorable surgical outcomes. The difficulty in achieving total removal of unconventional PitNETs, especially in the presence of vessel encasement and recurrent lesions, should raise the awareness of the increased risk of suprasellar tumor remnant apoplexy and arterial vasospasm, particularly in tumors with subarachnoid invasion
Real-world outcomes after discontinuation of covalent BTK inhibitor-based therapy in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma.
No full textThis study described real-world treatment patterns and outcomes among patients with CLL/SLL in the post-cBTKi setting. Included were patients who received at least one cBTKi and subsequent line of therapy (LOT) within the Flatiron Health nationwide electronic health record-derived de-identified database (FHD; N = 1,479) and Optum\u27s de-identified Clinformatics® Data Mart Database (CDM; N = 1,020). Frequently observed post-cBTKi treatments in both databases included cBTKi monotherapy (23-30%), anti-CD20 mab monotherapy (∼10%), BCL2i monotherapy (∼9%), BCL2i + anti-CD20 mab (∼9%), cBTKi + BCL2i (∼3%), and cBTKi + anti-CD20 mab (5-7%). From start of immediate LOT following cBTKi discontinuation, median time-to-treatment-discontinuation ranged across databases between 6 and 9 months; median time-to-next-treatment and median overall survival ranged between 18-23 months and 36-57 months, respectively. Observed heterogeneity in treatment patterns and outcomes in two cohorts of patients with CLL/SLL suggests lack of clarity in clinical evidence for treatment choice, and there remains a need for treatment options that deliver improved outcomes in the post-cBTKi setting
Cognitive effects of ocrelizumab vs interferon β-1a in relapsing multiple sclerosis: A post hoc analysis of the OPERA I/II trials.
No full textBACKGROUND: Cognitive impairment is a well-recognized symptom of multiple sclerosis (MS) that can manifest early in the disease course. Deficits in cognitive function can have a major impact on daily life. However, cognitive decline is often under-examined in clinical trials and clinical practice due to lack of adequate data. The objective of this study was to examine the longitudinal effect of ocrelizumab vs interferon beta (IFNβ)-1a on cognitive impairment in 2 phase 3 studies in relapsing MS (RMS).
METHODS: The pooled population of participants with RMS (n = 1656) from the OPERA I/II clinical trials received subcutaneous IFNβ-1a (44 μg; n = 829) 3 times weekly or intravenous ocrelizumab (600 mg; n = 827) every 24 weeks. Cognition was assessed with a Symbol Digit Modalities Test (SDMT), administered in written or oral form according to each site investigator\u27s choice, that primarily measured cognitive processing speed at baseline and every 12 weeks until the end of the double-blind treatment (96 weeks). Treatment effects were investigated based on longitudinal linear models for the change from baseline in SDMT and Cox regression for the time to 12- or 24-week confirmed decline of ≥4 points.
RESULTS: Among the participants with an SDMT assessment at baseline and ≥1 postbaseline time point (IFNβ-1a, n = 749; ocrelizumab, n = 766), ocrelizumab treatment was associated with a greater mean SDMT improvement over 96 weeks than IFNβ-1a treatment (5.4 [95 % CI, 4.4-6.5] vs 4.0 [95 % CI, 3.0-5.1]; adjusted mean difference, 1.4 [95 % CI, 0.05-2.72]; P = 0.042). The risk of a clinically meaningful SDMT decline (≥4 points) was lower for those treated with ocrelizumab for both ≥12 weeks (IFNβ-1a, 18.4 %; ocrelizumab, 12.7 %; hazard ratio, 0.63 [95 % CI, 0.47-0.85]; P = 0.003) and ≥24 weeks (IFNβ-1a, 12.9 %; ocrelizumab, 7.9 %; HR, 0.57 [95 % CI, 0.39-0.82]; P = 0.003).
CONCLUSION: Ocrelizumab treatment resulted in better cognitive outcomes as measured by SDMT in participants with RMS compared with IFNβ-1a treatment. However, methodological limitations need to be considered when interpreting these data.
CLINICALTRIALS: gov: NCT01247324, NCT01412333
Perspectives on the role of -Omics in predicting response to immunotherapy.
No full textThe annual Immuno-Oncology Think Tank held in October 2023 in Siena reviewed the rapidly evolving systems-biological approaches which are now providing a deeper understanding of tumor and tumor microenvironment heterogeneity. Based on this understanding opportunities for novel therapies may be identified to overcome resistance to immunotherapy. There is increasing evidence that malignant disease processes are not limited to purely intracellular or genetic events but constitute a dynamic interaction between the host and disease. Tumor responses are influenced by many host tissue determinants across different cellular compartments, which can now be investigated by high-throughput molecular profiling technologies, often labelled with a suffix -omics . Omics together with ever increasing computational power, fast developments in machine learning, and high-resolution detection tools offer an unrivalled opportunity to connect high-dimensional data and create a holistic view of disease processes in cancer. This review describes advances in several state-of-the-art -omics approaches with perspectives on how these can be applied to the clinical development of new immunotherapeutic strategies and ultimately adopted in clinical practice
Outcomes of Surgically Implanted Impella Microaxial Flow Pumps in Heart Failure-Related Cardiogenic Shock.
No full textBACKGROUND: Patients with cardiogenic shock (CS) are increasingly treated with high-profile microaxial flow pumps (Impella 5.5), but little is known about the indications and outcomes of this support strategy in patients with CS due to heart failure (HF-CS).
OBJECTIVES: We sought to describe the clinical features and outcomes of patients with HF-CS treated with Impella 5.5.
METHODS: We analyzed data from a prospective, multicenter observational study of patients with CS who had been implanted with an Impella 5.5. Adverse events, in-hospital survival rates and 6- and 12-month survival rates were analyzed in the total cohort and between patients treated with Impella 5.5 alone or with multiple temporary mechanical circulatory support (tMCS) devices. Outcomes were stratified based on native heart survival (NHS) and heart-replacement therapy (HRT).
RESULTS: Of the 804 patients with CS who received Impella 5.5, 444 had HF-CS. Prior to Impella 5.5 placement, 214 (48.1%) had received other tMCS devices. The duration of Impella support was 21.1 ± 20.1 days (median: 15; IQR: 8, 26 days). Survival to discharge was 75.0% for the total cohort, 86.5% for those receiving Impella 5.5 alone, and 65.0% for those receiving multiple tMCS devices. The need for renal-replacement therapy and thrombocytopenia requiring transfusions was more common in those receiving multiple tMCS devices. Among patients with NHS, 6- and 12-month survival rates were 71.3% and 64.4%, respectively, while patients receiving HRT had survival rates \u3e 93%.
CONCLUSIONS: Patients with HF-CS treated with Impella 5.5 had overall favorable in-hospital, 6-month and 12-month survival, both as a bridge to NHS as HRT
Effects of anti-inflammatory agents on clinical outcomes in people with chronic kidney disease: a systematic review and meta-analysis of randomized control trials.
No full textBACKGROUND: Chronic kidney disease (CKD) is characterized by chronic inflammation, which is strongly linked to risk of cardiovascular disease. Anti-inflammatory agents present a novel strategy to reduce the burden of cardiovascular disease in people with CKD, but their effects on clinical outcomes are uncertain.
METHODS: A systematic review and meta-analysis was performed to assess the efficacy and safety of anti-inflammatory agents in CKD (PROSPERO CRD42021238755). Medline, Embase and Cochrane databases were searched up to 8 October 2024 for randomized controlled trials of anti-inflammatory agents in CKD with at least 100 patient-years follow-up per treatment arm. The primary study outcome was major adverse cardiovascular events (MACE; defined as myocardial infarction, stroke or cardiovascular death). Other outcomes included CKD progression, malignancy and infection.
RESULTS: Nine trials of 12 042 participants and six different anti-inflammatory classes were identified. Overall, anti-inflammatory agents did not reduce the risk of MACE [risk ratio (RR) 1.01, 95% confidence interval (CI) 0.81-1.24], although there was significant heterogeneity across studies (
CONCLUSION: There is currently insufficient evidence to support the use of anti-inflammatory agents to reduce cardiovascular risk or CKD progression in people with CKD, and further dedicated studies in this population are warranted. The potential increased risk of infection with anti-inflammatory agents is an important consideration in the evaluation of these therapies in CKD
Associations between fine particulate matter and in-home blood pressure during the 2022 wildfire season in Western Montana, USA.
No full textWildfires continue to increase in size, intensity, and duration. There is growing evidence that wildfire smoke adversely impacts clinical outcomes; however, few studies have assessed the impact of wildfires on household air quality and subclinical cardiovascular health indicators. We measured continuous indoor and outdoor fine particulate matter (PM2.5) concentrations from July-October 2022 at 20 residences in the rural, mountainous state of Montana in the United States. We used a combination of satellite-derived smoke plume data from the National Oceanic and Atmospheric Administration\u27s Hazard Mapping System and household-level daily mean PM2.5 concentrations to classify wildfire-impacted days. One participant from each household self-reported in-home blood pressure (BP) on weekly electronic surveys. We used linear mixed-effects regression models to assess associations between air pollution exposures (PM2.5 concentrations; number of wildfire-impacted days) and systolic BP (SBP) and diastolic BP (DBP). Models were adjusted for potential time-variant confounders including temperature, humidity, and self-reported exercise. Compared to survey periods with 0 wildfire days, SBP was 3.83 mmHg higher (95% Confidence Interval [95% CI]: 0.22, 7.44) and DBP was 2.36 mmHg higher (95% CI: -0.06, 4.78) during periods with 4+ wildfire days. Across the entire study period, a 10 µg m-3 increase in indoor PM2.5 was associated with 1.34 mmHg higher SBP (95%CI: 0.39, 2.29) and 0.71 mmHg higher DBP (95% CI: 0.07, 1.35). We observed that wildfire-impacted days and increasing household-level PM2.5 concentrations are associated with higher in-home BP. Our results support growing literature which indicates that wildfires adversely impact subclinical cardiovascular health. Clinical and public health messaging should emphasize the cardiovascular health impacts of wildfire smoke and educate on exposure-reduction strategies such as indoor air filtration