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Endovascular versus surgical revascularization for patients with chronic limb-threatening ischemia: A systematic review and meta-analysis of randomized controlled trials
No full textRetrospective Multicenter Analysis of Intravascular Lithotripsy Use During Calcified Left Main Coronary Artery Percutaneous Coronary Interventions
No full textBACKGROUND: Intravascular lithotripsy (IVL) safely and effectively modifies calcified coronary lesions during percutaneous coronary interventions (PCI). Data regarding its utility in modifying calcified left main coronary artery (LMCA) disease are limited. This study aimed to evaluate short-term outcomes of IVL-assisted LMCA PCI.
METHODS: This retrospective multicenter all-comers study analyzed patients who underwent intravascular imaging-guided, IVL-assisted PCI for calcified LMCA disease. Clinical and procedural characteristics were obtained, including intravascular imaging measurements. Technical success was defined as successful stent deployment with \u3c30% residual diameter stenosis. Major adverse cardiac events (MACE) was a composite of all-cause death, myocardial infarction, and target vessel revascularization evaluated immediately postprocedure and at 30-day follow-up.
RESULTS: Among 184 patients treated at 7 centers from 2019-2023, IVL-assisted LMCA PCI achieved 99.4% technical success. Calcium fracture was identified in 136/165 cases (82.4%) on post-IVL imaging. Pretreatment minimal luminal area increased significantly compared to post-PCI minimal stent area (MSA) (4.1 ± 1.3 to 9.3 ± 2.5 mm(2), respectively; P \u3c .001). There was a direct correlation between IVL balloon size and the final MSA (P = .002). In-hospital MACE was 4.4% and 30-day MACE was 8.8%. In multivariate logistic regression, presentation with troponin-positive myocardial infarction was the sole predictor of 30-day MACE.
CONCLUSIONS: IVL-assisted PCI for calcified LMCA lesions was safe and resulted in high technical success rates, confirming its utility as an effective treatment in this challenging lesion subset
Perinatal Psychotherapy Use and Costs Before and After Federally Mandated Health Insurance Coverage
No full textIMPORTANCE: Insurance coverage affects health care access for many delivering women diagnosed with perinatal mood and anxiety disorders (PMADs). The Mental Health Parity and Addiction Equity Act (MHPAEA; passed in 2008) and the Patient Protection and Affordable Care Act (ACA; passed in 2010) aimed to improve health care access.
OBJECTIVE: To assess associations between MHPAEA and ACA implementation and psychotherapy use and costs among delivering women overall and with PMADs.
DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study conducted interrupted time series analyses of private insurance data from January 1, 2007, to December 31, 2019, for delivering women aged 15 to 44 years, including those with PMADs, to assess changes in psychotherapy visits in the year before and the year after delivery. It estimated changes in any psychotherapy use and per-visit out-of-pocket costs (OOPCs) for psychotherapy associated with MHPAEA (January 2010) and ACA (January 2014) implementation. Data analyses were performed from August 2022 to May 2023.
EXPOSURES: Implementation of the MHPAEA and ACA.
MAIN OUTCOMES AND MEASURES: Any psychotherapy use and per-visit OOPCs for psychotherapy standardized to 2019 dollars.
RESULTS: The study included 837 316 overall deliveries among 716 052 women (mean [SD] age, 31.2 [5.4] years; 7.6% Asian, 8.8% Black, 12.8% Hispanic, 64.1% White, and 6.7% unknown race and ethnicity). In the overall cohort, a nonsignificant step change was found in the delivering women who received psychotherapy after MHPAEA implementation of 0.09% (95% CI, -0.04% to 0.21%; P = .16) and a nonsignificant slope change of delivering women who received psychotherapy of 0.00% per month (95% CI, -0.02% to 0.01%; P = .69). A nonsignificant step change was found in delivering individuals who received psychotherapy after ACA implementation of 0.11% (95% CI, -0.01% to 0.22%; P = .07) and a significantly increased slope change of delivering individuals who received psychotherapy of 0.03% per month (95% CI, 0.00% to 0.05%; P = .02). Among those with PMADs, the MHPAEA was associated with an immediate increase (0.72%; 95% CI, 0.26% to 1.18%; P = .002) then sustained decrease (-0.05%; -0.09% to -0.02%; P = .001) in psychotherapy receipt; the ACA was associated with immediate (0.77%; 95% CI, 0.26% to 1.27%; P = .003) and sustained (0.07%; 95% CI, 0.02% to 0.12%; P = .005) monthly increases. In both populations, per-visit monthly psychotherapy OOPCs decreased (-0.24 to -0.22; -0.12; P \u3c .001 for the PMAD population) after MHPAEA passage with an immediate increase (1.56-2.54 [95% CI, 4.54]; P = .01) and steady monthly increase (0.02-0.10 [95% CI, 0.17]; P = .004) after ACA passage.
CONCLUSIONS AND RELEVANCE: This study found complementary and complex associations between passage of the MHPAEA and ACA and access to psychotherapy among delivering individuals. These findings indicate the value of continuing efforts to improve access to mental health treatment for this population
North American Expert Consensus on the Post-procedural Care of Patients After Per-oral Endoscopic Myotomy Using a Delphi Process
No full textBACKGROUND & AIMS: There is significant variability in the immediate post-operative and long-term management of patients undergoing per-oral endoscopic myotomy (POEM), largely stemming from the lack of high-quality evidence. We aimed to establish a consensus on several important questions on the after care of post-POEM patients through a modified Delphi process.
METHODS: A steering committee developed an initial questionnaire consisting of 5 domains (33 statements): post-POEM admission/discharge, indication for immediate post-POEM esophagram, peri-procedural medications and diet resumption, clinic follow-up recommendations, and post-POEM reflux surveillance and management. A total of 34 experts participated in the 2 rounds of the Delphi process, with quantitative and qualitative data analyzed for each round to achieve consensus.
RESULTS: A total of 23 statements achieved a high degree of consensus. Overall, the expert panel agreed on the following: (1) same-day discharge after POEM can be considered in select patients; (2) a single dose of prophylactic antibiotics may be as effective as a short course; (3) a modified diet can be advanced as tolerated; and (4) all patients should be followed in clinic and undergo objective testing for surveillance and management of reflux. Consensus could not be achieved on the indication of post-POEM esophagram to evaluate for leak.
CONCLUSIONS: The results of this Delphi process established expert agreement on several important issues and provides practical guidance on key aspects in the care of patients following POEM
Beyond the Surface: Unveiling Hidden Hurdles to Primary Biliary Cholangitis Care
No full textINTRODUCTION: Ursodeoxycholic acid (UDCA) slows disease progression among patients with primary biliary cholangitis (PBC), yet not all patients receive this standard-of-care medication. Our study aims to identify reasons why PBC patients did not receive the recommended UDCA treatment.
METHODS: Using medical record data collected by the Fibrotic Liver Disease (FOLD) Consortium for 2006-2016, we identified PBC patients from a single site with no UDCA therapy record. Two independent reviewers used a structured data collection instrument to systematically confirm and record the reasons for the lack of treatment.
RESULTS: Among 494 PBC patients (11% men and 13.2% Black patients) with a median follow-up of 5.2 years, 35 (7%) had never received UDCA (16% men and 24% Black patients). Of these, 18 (51%) had laboratory indications of PBC but were not formally diagnosed. Among the remaining 17 patients with recognized PBC, six were never offered UDCA, seven declined treatment, and four remained untreated despite being offered treatment. We did not find a statistically significant association between the lack of PBC diagnosis and treatment and patients\u27 age (p = 0.139), gender (p = 0.222), race (p = 0.081), or insurance coverage (p = 0.456), perhaps due to our small sample size.
CONCLUSIONS: Multiple factors influencing the lack of evaluation and treatment in PBC patients were identified at the provider and patient levels. The most common reasons included financial barriers, loss to follow-up, severe decompensated disease at diagnosis, and lack of referral to specialists for further evaluation. Future interventions targeting modifiable provider and patient barriers may improve rates and timeliness of PBC diagnosis and treatment
Sequential Peg-IFN after bepirovirsen may reduce post-treatment relapse in chronic hepatitis B
No full textBACKGROUND & AIMS: Bepirovirsen, an antisense oligonucleotide, induces sustained hepatitis B surface antigen (HBsAg) and hepatitis B virus (HBV) DNA below lower limit of quantification (
METHODS: Phase 2b, multicentre, randomised, open-label trial. Participants on stable nucleos(t)ide analog (NA) therapy were randomised 1:1 to bepirovirsen 300 mg once weekly (plus loading dose on Days 4 and 11) for 24 (Arm 1) or 12 (Arm 2) weeks followed by Peg-IFN 180 mcg once weekly for up to 24 weeks, with up to 36 weeks follow-up. Participants continued NA therapy throughout.
PRIMARY OUTCOME: proportion of participants with HBsAg \u3c0.05 IU/mL and HBV DNA
RESULTS: The intent-to-treat population included 108 participants (Arm 1=55; Arm 2=53). The primary outcome was achieved by 5 (9%) participants in Arm 1 and 8 (15%) in Arm 2. All responders had baseline HBsAg ≤3000 IU/mL. Indirect comparison with the Phase 2b study B-Clear indicates that sequential addition of Peg-IFN may reduce the relapse rates previously observed with bepirovirsen alone. The proportions of participants with adverse events (AEs) and treatment-related AEs in both treatment windows were similar between treatment arms.
CONCLUSIONS: Sequential therapy with bepirovirsen followed by Peg-IFN is tolerable and effective in participants with chronic HBV infection on stable NA. This proof-of-concept trial demonstrates a potential strategy to extend responses to bepirovirsen by reducing relapse.
FUNDING: GSK (study 209348/NCT04676724). CLINICAL TRIAL NUMBER: NCT04676724
Unilateral Sinus Disease: What Is, and Is Not Odontogenic Sinusitis?
No full textThe differential diagnosis of unilateral sinus disease (USD) is broad, and while concerning etiologies like sinonasal neoplasia, invasive fungal sinusitis, and cerebrospinal fluid rhinorrhea should always be considered, most cases are due to noninvasive inflammatory or infectious conditions. To diagnose USD appropriately, clinicians must integrate the clinical history and examination, nasal endoscopy, computed tomography (CT), and possibly MRI. Odontogenic sinusitis (ODS) is the most common cause of unilateral maxillary sinus opacification on CT, with 45% to 75% of such cases being odontogenic in nature. This study provides USD diagnostic considerations and reinforces the diagnostic approach to ODS
Collaboration between otolaryngologists and oral surgeons in maxillary sinus elevation planning
No full textBACKGROUND: The collaboration between otolaryngologists and dental providers is crucial for the planning and execution of maxillary sinus elevation (MSE) procedures, which are integral to successful dental implant placements.
PURPOSE: This article examines the essential role of otolaryngological assessments in identifying potential sinonasal risks that could impact the outcomes of MSE.
MATERIALS AND METHODS: A comprehensive narrative review of existing literature was conducted.
DISCUSSION: The review underscores the importance of thorough preoperative evaluations, including patient history, computed tomography (CT) or cone-beam CT (CBCT) scans, and nasal endoscopy, to mitigate sinonasal health risks. It details various clinical scenarios and patient assessments, emphasizing a systematic approach to diagnosing and managing sinonasal conditions proactively. The discussion reveals that while some sinus conditions may not significantly affect MSE success, conditions impacting mucociliary clearance and sinus drainage are critical risk factors requiring otolaryngological intervention. Additionally, the article introduces a grading system to assist clinicians in identifying patients who would benefit from otolaryngological evaluations prior to MSE.
CONCLUSION: This review highlights the value of interdisciplinary collaboration and standardized protocols in enhancing the predictability and safety of MSE procedures, ultimately improving patient outcomes
Persistent endocrine-disrupting chemicals and incident uterine leiomyomata: A mixtures analysis
No full textBACKGROUND: Uterine leiomyomata (UL; fibroids) are hormone-dependent neoplasms that can cause significant gynecologic morbidity. Studies have documented associations between concentrations of persistent endocrine-disrupting chemicals (EDCs) and UL incidence; however, few have assessed the effects of EDC mixtures on UL.
METHODS: In the Study of Environment, Lifestyle, and Fibroids, a prospective cohort study, participants attended study visits at baseline and approximately every 20 months for up to 10 years; at each visit, they completed questionnaires, provided blood samples, and underwent standardized ultrasound examinations. In baseline plasma samples (n = 1155), we quantified concentrations of polychlorinated biphenyls (PCBs), polybrominated diphenyl ethers (PBDEs), and organochlorine pesticides using high-resolution mass spectrometry. We selected nine EDCs detected in \u3e60 % of samples (4 PCBs, 4 PBDEs, and 2,2-bis(4-chlorophenyl)-1,1-dichloroethene (p,p\u27-DDE)) and conducted probit Bayesian kernel machine regression with hierarchical variable selection to estimate effects of the EDC mixture and individual EDCs on UL incidence, adjusting for potential confounders.
RESULTS: During 10 years of follow-up, 32 % of participants developed ultrasound-detected UL. The EDC mixture was not appreciably associated with the probit of UL (β comparing all EDCs at their 75th vs. 50th percentile:= - 0.01, 95 % credible interval [CrI]: -0.11, 0.10). However, individual EDC concentrations were associated with UL in opposing directions: PCB138/158 was positively associated with UL (β for 25th-to-75th-percentile increase when all other chemicals were set to their 50th percentile = 0.18, 95 % CrI: -0.09, 0.44), whereas PBDE99 and p,p\u27-DDE were inversely associated with UL (β = -0.06, 95 % CrI: -0.21, 0.10 and β = -0.12, 95 % CrI: -0.34, 0.10, respectively). There was little evidence of interaction between EDCs.
CONCLUSION: In this prospective ultrasound study, a mixture of persistent EDCs was not appreciably associated with incident UL during 10 years of follow-up, but individual EDCs were associated with UL in opposite directions
