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Early Feasibility Study of the Edwards SAPIEN 3 Transcatheter Heart Valve System With the Edwards Caval Prestent for the Treatment of Reverse Caval Flow in Patients With Severe Tricuspid Regurgitation (TR).
No full textBACKGROUND AND AIMS: Caval valve implantation has emerged as an alternative to orthotopic valve replacement for patients with severe TR and right heart failure. Current devices are focused primarily on bicaval implantation. The outcomes for patients with (inferior vena cava) IVC implantation only are less clear. The aim of this study was to assess the impact of IVC Caval Valve Implantation on patients with severe TR and heart failure.
METHODS: The RIGHT FLOW trial enrolled patients with severe TR and right heart failure as part of an early feasibility study between November 2021 and December 2022.
RESULTS: A total of 10 patients were included. The average age of patients was 78.8 ± 6.7 years. Most patients had NYHA class III/IV heart failure symptoms (78.8%). The average overall Kansas City Cardiomyopathy Questionnaire (KCCQ-OS) score at baseline was 36.9 ± 22.8. Successful device delivery occurred in 9/10 of patients. Post-implant, there was an increase in right atrial (RA) pressure that returned to baseline at 6 months. Hepatic vein diameter decreased from (13.1 + 3.1 mm at baseline to 8.7 + 3.0 mm at 12 months). Six patients survived to 12 months. Of those patients, all had NYHA Class I/II symptoms. Of patients completing follow-up, KCCQ-OS scores increased by 43.4 points at 1-year. Computer tomography revealed asymptomatic stent fractures in 7 patients.
CONCLUSIONS: Caval valve implantation with the Edwards Caval Prestent system in the IVC only was feasible and safe in patients with severe TR. Patients exhibited a decrease in hepatic vein diameter. There were significant improvements in KCCQ-OS scores beginning at 30 days that continued out to 1 year. Future design iterations are needed to address stent fractures
Clinical Profile of Halobetasol Propionate 0.01%/ Tazarotene 0.045% Lotion in Patients With Hyperkeratotic Plaque Psoriasis
No full textBACKGROUND: Hyperkeratotic psoriatic plaques, characterized by considerable elevation and scaling, present treatment challenges with topical therapy. This post hoc analysis of two phase 3 trials evaluated the efficacy and tolerability of fixed-combination halobetasol propionate (0.01%) and tazarotene (0.045%) lotion (HP/TAZ; indicated for the topical treatment of plaque psoriasis in adults) in treating hyperkeratotic plaques.
METHODS: Participants received HP/TAZ or vehicle daily for 8 weeks, with a 4-week posttreatment follow-up. Multiple subpopulations represented patients with hyperkeratotic plaques. Analysis 1 included a subgroup with severe plaque elevation and a second subgroup with severe scaling. Analysis 2 included a subgroup with either an investigator\u27s global assessment (IGA) of 3 with moderate-to-severe plaque elevation or an IGA of 4. Endpoints included plaque elevation and/or scaling success (greater than or equal to 2-grade improvement for either) and safety assessments.
RESULTS: At week 8, the severe plaque elevation subgroup and severe scaling subgroup achieved plaque elevation and scaling success, respectively, at significantly greater rates with HP/TAZ versus vehicle (P\u3c 0.05 for all; Analysis 1). Analysis 2 participants achieved significantly greater rates of plaque elevation and scaling success with HP/TAZ versus vehicle at week 8 (P less than or equal to 0.001 for all). Tolerability improved from baseline by \u3e46% for all subgroups. Adverse events were similar between treatment groups.
CONCLUSION: HP/TAZ was efficacious and well tolerated for treating hyperkeratotic plaques
Oral Vancomycin for Prevention of Recurrent Clostridioides difficile Infection: A Randomized Clinical Trial
No full textIMPORTANCE: Systemic antibiotic use for patients with a non-Clostridioides difficile infection (CDI) is a major risk factor for recurrent CDI. Increasing use of oral vancomycin for secondary prophylaxis against recurrent CDI in this context has uncertain efficacy.
OBJECTIVE: To evaluate whether oral vancomycin prophylaxis compared with placebo is effective against recurrent CDI during and 8 weeks after the end of study treatment.
DESIGN, SETTING, AND PARTICIPANTS: This phase 2, placebo-controlled, double-blind randomized clinical trial was conducted in 4 large health systems across the upper Midwest US. Adults who had completed treatment for CDI within the past 180 days and were taking a systemic antibiotic for a non-CDI indication were enrolled between May 21, 2018, and March 30, 2023, and followed up for 8 weeks after the end of study treatment.
INTERVENTION: Participants were randomized 1:1 to 125 mg of oral vancomycin or placebo once daily during antibiotic use for a non-CDI plus 5 days following cessation of those antibiotics.
MAIN OUTCOMES AND MEASURES: The primary outcome was recurrent CDI incidence during treatment and the 8-week follow-up period. The secondary outcome was vancomycin-resistant Enterococcus carriage in stool.
RESULTS: Among 81 randomized participants (median age, 59 years [IQR, 50-67 years]), all were included in the primary as-randomized analysis (39 in the vancomycin group; 42 in the placebo group). Sixty patients (74.1%) completed 8-week follow-up and were included in the secondary as-completed treatment analysis (31 in the vancomycin group; 29 in the placebo group). Recurrent CDI occurred in 17 of 39 participants in the oral vancomycin group (43.6%) and 24 of 42 in the placebo group (57.1%; absolute difference in percentage, -13.5% [95% CI, -35.1% to 8.0%]). Adverse events occurred in 27 of 39 participants in the oral vancomycin group (69.2%) and 27 of 42 in the placebo group (64.3%). Vancomycin-resistant Enterococcus carriage was found in 15 of 30 patients in the oral vancomycin group (50.0%) and 6 of 25 in the placebo group (24.0%) (P = .048) 8 weeks after treatment.
CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, the incidence of recurrent CDI was lower (though did not reach significance) in participants taking oral vancomycin compared with those taking placebo. Because the study was underpowered, it was unable to reveal firm conclusions about the efficacy (or lack thereof) of vancomycin prophylaxis with respect to recurrent CDI.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03462459
Immunotherapy-Induced Cardiotoxicity: A Narrative Review of Real-World Case Reports, Recent Information and Clinical Evidence
No full textImmunotherapy is revolutionizing the treatment of cancer and other conditions. However, it also precipitates a loss of self-tolerance and causes immune-related adverse events (irAEs). We provide a narrative synthesis of the scopes and methods of immunotherapy and mechanisms, clinical presentation, and diagnostic considerations of cardiovascular irAEs while providing real-world examples and perspectives. Recent real-world cases and emerging evidence suggest myocarditis is the most common and potentially fatal cardiovascular irAE, often presenting with symptoms such as shortness of breath or chest pain within weeks of therapy initiation. Other cardiotoxic effects include arrhythmias such as tachyarrhythmias or conduction blocks, heart failure, takotsubo cardiomyopathy, and pericardial disease, sometimes with pericardial effusion. These events can be severe, requiring prompt recognition and intervention to avoid deterioration. Diagnosis typically involves surveillance, a high index of suspicion, biomarker elevations, imaging modalities, cardiac magnetic resonance, and in select cases, endomyocardial biopsy. Early cessation of immunotherapy and high-dose corticosteroids frequently help stabilize acutely ill patients with additional immunomodulators such as intravenous immunoglobulin or abatacept considered in steroid-refractory cases. Clinicians are urged to adopt a multidisciplinary approach involving close cardiology collaboration for baseline risk evaluation, structured surveillance, and cautious rechallenge decisions. Despite these challenges, immunotherapy remains vital for the management of many malignancies. Ongoing research into targeted immunomodulation, refined imaging protocols, and genetic profiling may enhance clinical outcomes by enabling prevention, earlier detection and safer management of cardiovascular irAEs
Acute Prostatitis and Septic Shock Following Rectal Spacer Placement: A Case Report of a Pre-brachytherapy Complication
No full textRectal spacers are commonly used in the treatment of prostate cancer to create a protective barrier to reduce radiation-induced toxicity to the rectum. Despite their safety profile, severe complications such as infections are rare but clinically significant. We present the case of a 69-year-old male with Gleason Grade 3+4 (Score 7) who developed acute prostatitis and septic shock one day after rectal spacer placement. He presented with fever, chills, nausea, and emesis, alongside profound hypotension necessitating vasopressor support. Blood and urine cultures identified Morganella morganii, prompting targeted antibiotic therapy with piperacillin-tazobactam. Imaging revealed abdominal edema and mild ascites without abscess or hematoma. The patient recovered with intensive care and was discharged on a prolonged course of antibiotics. This case highlights the rare but severe infectious complications of rectal spacer placement and underscores the importance of early recognition and intervention. Future studies should explore preventive strategies, including prophylactic antibiotics, to mitigate such risks
A Systematic Review of the Parkinson\u27s Foundation Hospital Care Recommendations
No full textBACKGROUND: People with Parkinson\u27s disease (PwP) face increased risks of complications and longer hospital stays compared to the general population. Four major factors contribute to increased morbidity and mortality during hospitalization: medication timing errors, administration of harmful medications, restricted mobility, and dysphagia.
OBJECTIVES: To systematically review the literature on medication timing, contraindicated medications, mobility, and dysphagia in hospitalized PwP, and to evaluate the strength of evidence supporting the Parkinson\u27s Foundation\u27s consensus recommendations for inpatient care.
METHODS: A systematic review was conducted by searching MEDLINE and EMBASE databases up to February 1, 2024. Original research articles involving hospitalized PwP were included. The level of evidence for each Parkinson\u27s Foundation recommendations was assessed.
RESULTS: The review included 33 studies. Multiple studies showed that medication errors were associated with longer hospital stays, motor deterioration, and increased mortality in PwP. Interventions such as electronic medical record alerts, staff education, and specialized PD units reduced medication errors. Limited evidence was found on the impact of immobility and dysphagia during hospitalization.
CONCLUSIONS: The evidence base supporting the Parkinson\u27s Foundation\u27s hospital care recommendations varies in strength. Recommendations regarding medication timing and avoiding harmful medications are supported by multiple observational studies, while those for mobility and dysphagia are primarily based on expert opinion. Implementing these recommendations through multidisciplinary interventions may improve hospital care quality for PD. However, more high-quality research, including randomized controlled trials, is needed to evaluate intervention impacts and address identified knowledge gaps
The Effect of Oncoplastic Reduction Mammoplasty on the Incidence of Breast Lymphedema in Women Undergoing Breast Conservation Surgery
No full textINTRODUCTION: Women with macromastia are susceptible to less favorable postoperative outcomes following breast conservation surgery (BCS). Among those, breast lymphedema is a severe complication that impacts functional and aesthetic outcomes. However, effective prevention strategies remain understudied. We aim to assess whether women with macromastia who receive oncoplastic reduction mammoplasty (ORM) have reduced incidence of postoperative breast lymphedema compared with patients who receive BCS alone.
METHODS: A retrospective analysis of patients who underwent BCS alone or ORM followed by radiation was conducted. Demographics, treatment details, operative techniques, and postoperative outcomes were compared between BCS alone and ORM groups using inferential statistics. A subanalysis was similarly conducted to identify differences in postoperative outcomes between women with and without macromastia. Regression analysis was used to evaluate the effects of ORM and the factors associated with breast lymphedema.
RESULTS: The overall incidence of breast lymphedema was 10.6%. Black race, preoperative breast volume ≥ 1500 cm(3), axillary lymph node dissection at time of surgery, incidence of cellulitis, and incidence of arm lymphedema were positively associated with breast lymphedema rate. Regression analysis demonstrated that women with breast volumes ≥ 1500 cm(3) who underwent BCS alone were 6.575 times more likely to develop breast lymphedema than patients who underwent ORM (p = 0.014).
CONCLUSIONS: Women with macromastia who receive BCS alone have an increased incidence of postoperative breast lymphedema. Oncoplastic reduction mammoplasty is an alternative treatment option that reduces the likelihood of postoperative breast lymphedema compared with BCS alone in patients with breast volumes ≥ 1500 cm(3)
The effects of docosahexaenoic acid (DHA) on plasma cytokines, oxylipins, and tumor-infiltrating lymphocytes from women with breast cancer undergoing neoadjuvant chemotherapy in the DHA-WIN trial
No full textClinical trials on docosahexaenoic acid (DHA) supplementation and immune changes during breast cancer neoadjuvant chemotherapy (NAC) are limited. This study evaluated the impact of DHA supplementation during NAC on systemic and tumor immune modulation by assessing plasma inflammatory and cardiac damage markers, tumor-infiltrating lymphocyte (TIL) proportions, and n-6- and n-3-derived oxylipins produced in response to an ex vivo immune challenge. Venous blood was collected at baseline, 9, and 15 weeks during NAC from participants in the DHA for Women with Breast Cancer in the Neoadjuvant Setting (DHA-WIN) trial, which compared DHA-enriched algae (4.4g/day; n=23) with a placebo (n=26) over 18 weeks. Plasma markers were measured using electrochemiluminescence assays. CD4+ and CD8+ TILs were identified in tumor tissue by immunohistochemistry, and oxylipins were quantified in the supernatant of lipopolysaccharide-stimulated peripheral blood mononuclear cells via liquid chromatography-tandem mass spectrometry. DHA supplementation resulted in greater increases in the plasma cytokines IFN-γ and TNF-α compared to placebo (P-interaction \u3c .05). In the DHA group, concentrations of these cytokines increased at 15 weeks compared to baseline (P \u3c .05). No differences were found between groups for other immune markers or the proportion of TILs. Compared to the placebo, DHA led to an overall increase in total oxylipin concentrations (P \u3c .05) and higher production of n-6 fatty acid-derived oxylipins, particularly prostanoids, and n-3 fatty acid-derived oxylipins, including 13-HDoHE. These results suggest that DHA may enhance immune responses by promoting an increase in oxylipin and cytokine concentrations, potentially benefiting patients during breast cancer NAC
Safety and Sample Adequacy for Comprehensive Biomarker Testing of Bronchoscopic Biopsies: An American Association of Bronchology and Interventional Pulmonology and International Association for the Study of Lung Cancer Clinical Practice Guideline
No full textLinear endobronchial ultrasound-guided sampling of accessible mediastinal lesions is well established as a first-choice modality for lung cancer mediastinal staging. Parenchymal lung lesions, however, are routinely accessed by either a percutaneous (computed tomography guided) or a bronchoscopic approach. Direct comparisons between the percutaneous approach and bronchoscopy, endobronchial ultrasound, or mediastinoscopy are sparse in regard to diagnostic accuracy, and it remains unknown which sampling technique is the safest and offers the most adequate material for comprehensive biomarker testing. This guideline addresses new evidence and aims to answer these questions relevant to contemporary lung cancer clinical practice. A multidisciplinary expert panel from the American Association of Bronchology and Interventional Pulmonology and the Early Detection and Screening Committee of the International Association for the Study of Lung Cancer was convened to address four Patient, Intervention, Comparison, and Outcome questions pertaining to the safety and adequacy of comprehensive biomarker testing for frequently used intrathoracic biopsy techniques. The panel included 24 experts in thoracic procedures, including 18 pulmonologists, two radiologists, one pathologist, and three thoracic surgeons from 22 hospitals across 12 countries. All panel members participated in the development of the final recommendations using a modified Delphi technique. Specific recommendations are provided on safety and adequacy of minimally invasive thoracic interventions on patients with confirmed or suspected lung cancer for which comprehensive biomarker testing is needed for standard of care or clinical trial participation
Sebaceous gland ectopia of the esophagus: A clinical, endoscopic, and pathologic study of a rare condition with literature review
No full textSebaceous gland ectopia (SGE) is a disorder in which sebaceous gland lobules appear in atypical anatomical locations. Sebaceous glands are normally found in the skin, particularly abundant on the face, scalp and other areas with hair follicles. SGE in the esophagus is an extremely rare, benign condition that morphologically may mimic epidermoid metaplasia due to the presence of excretory duct, lined by keratinized squamous epithelium. We present a retrospective case series of patients with evidence of SGE per endoscopic biopsy tissue analysis between 2000 and 2025. A total of 12 biopsy analyses from 10 patients were included: 7 women (70 %) and 3 men (30 %). The mean age at diagnosis was 63 years. There were 7 patients who reported previous or current alcohol use (70 %); one patient reported previous tobacco use (10 %). Gastrointestinal reflux disease, the most common clinical indication, was seen in six patients (60 %). The lesions, when visible on endoscopy, were located in the proximal and/or mid esophagus (100 %); three endoscopies noted no lesions (25 %). Two repeat biopsies in one patient showed persistent SGE. No biopsies showed dysplasia (0 %). Additionally, we performed a literature review of articles in the PubMed database, identifying 65 other reported patients. The clinicopathologic findings in this study add additional evidence on this rare entity