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Medicare Advantage Population in the United States: Outcomes of Patients with Asthma Treated with ICS/LABA Before and After Initiation with Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI)
No full textINTRODUCTION: The clinical benefits of fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) have been demonstrated in clinical trials. There is limited evidence regarding the effectiveness and economic outcomes associated with FF/UMEC/VI use in US clinical practice. This real-world study assessed asthma-related exacerbations, healthcare resource utilization (HRU), and healthcare costs among a Medicare Advantage-insured population before and after initiation of FF/UMEC/VI in patients with asthma previously treated with an inhaled corticosteroid/long-acting β(2)-agonist (ICS/LABA).
METHODS: De-identified data were obtained from the Komodo Health database (01/01/2016-12/31/2023) for adults with asthma who received prior ICS/LABA treatment and had ≥ 12 months of continuous Medicare Advantage coverage both pre- and post-FF/UMEC/VI initiation (index date). Rates of asthma-related exacerbations and HRU were compared using rate ratios (RR) from Poisson regressions. Healthcare costs were calculated per patient per year (PPPY) and compared using mean cost differences from generalized linear models.
RESULTS: In total, 2598 Medicare Advantage-insured patients who initiated FF/UMEC/VI for asthma were included. The mean ± SD age was 67.9 ± 12.3 years; 75.5% were female. The rate of overall asthma-related exacerbations was 31% lower in the post- versus pre-initiation period (RR 0.69; 95% CI 0.65, 0.73; p \u3c 0.001) and included a 24% lower rate of inpatient/emergency department (IP/ED)-defined exacerbations (RR 0.76; 95% CI 0.68, 0.85; p \u3c 0.001) and a 34% lower rate of systemic corticosteroid (SCS)-defined exacerbations (RR 0.66; 95% CI 0.61, 0.71; p \u3c 0.001). Asthma-related ED visits (RR 0.69; 95% CI 0.60, 0.80; p \u3c 0.001) and asthma-related outpatient (OP) visits (RR 0.77; 95% CI 0.71, 0.84; p \u3c 0.001) were both lower, and the mean reduction in cost was 575, $248; p \u3c 0.001), after FF/UMEC/VI initiation.
CONCLUSIONS: Initiation of FF/UMEC/VI after ICS/LABA treatment among Medicare Advantage-insured patients with asthma was associated with reduced rates of asthma-related exacerbations, ED and OP visits, and healthcare costs, highlighting the benefits of therapy escalation among this patient population
Rhinoconjunctivitis symptoms in children and adolescents with asthma: Longitudinal clustering analysis
No full textBACKGROUND: Rhinoconjunctivitis phenotypes are conventionally described on the basis of symptom severity, duration and seasonality, and aeroallergen sensitization. It is not known whether these phenotypes fully reflect the patterns of symptoms seen at a population level.
OBJECTIVE: We sought to identify phenotypes of rhinoconjunctivitis on the basis of symptom intensity and seasonality using an unbiased approach and to compare their characteristics.
METHODS: A cohort of children with asthma in low-income urban environments was prospectively followed with a rhinoconjunctivitis activity questionnaire, and their upper and lower airway disease was managed for 12 months with every 2-month visit based on standardized algorithms. We identified individual rhinoconjunctivitis symptom trajectories and clusters of those trajectories and compared the clusters focusing on atopic characteristics.
RESULTS: Data obtained from 619 children yielded 5 symptom clusters: 2 had high symptoms (22.5%) but differed in seasonal pattern, 1 had medium symptoms (13.6%), 1 had medium nasal congestion only (20.4%), and 1 had low symptoms (43.6%). The latter was further split into 2 subgroups if nasal corticosteroids were frequently prescribed (23.6%) or not (20.0%). Seasonal variation was absent in the low symptom clusters. The number of allergic sensitizations and family history of allergic airway disease were higher in the high symptom clusters, but allergic sensitization did not explain differences in seasonality.
CONCLUSIONS: This study identified rhinoconjunctivitis phenotypes that have not been previously reported and were not differentiated by demographics or by measures of atopy and type 2 inflammation. Factors beyond allergy need to be investigated to better understand the pathobiology of rhinoconjunctivitis
Preparing to implement shared decision making in anaesthesia for hip fracture surgery: a qualitative interview study
No full textBACKGROUND: Shared decision making is rarely used in anaesthesia consultations. Because either spinal or general anaesthesia can be appropriate for many patients undergoing surgery to repair a hip fracture, this is an appropriate context to implement and test shared decision making and associated resources for anaesthesia decisions. Conversation aids can facilitate shared decision making between clinicians, patients, and caregivers about treatment choices.
METHODS: We conducted semi-structured qualitative interviews at seven sites from April to September 2024 to prepare for implementation of a conversation aid about anaesthesia choices for hip fracture surgery. Interviews elicited feedback on shared decision making and a proposed conversation aid comparing spinal and general anaesthesia.
RESULTS: We interviewed 12 clinicians and 12 patients and caregivers. The analysis identified four themes, which we mapped to the Practical, Robust Implementation and Sustainability Model. We found (1) broad support for shared decision making in anaesthesia choices before hip fracture surgery, although it is not typically incorporated in current practice; (2) barriers to shared decision making, including institutional culture, preexisting clinician assumptions about patient preferences, and time; (3) features of a resource (i.e. the conversation aid) that can help overcome these barriers; and (4) the importance of engaging in shared decision making with an appropriate clinician. Suggestions from interviews were incorporated into the conversation aid.
CONCLUSIONS: Reasonable shared decision-making strategies such as conversation aids were seen by most participants as helpful to support shared decision making about anaesthesia options for hip fracture surgery. Engaging end users at the local level can address key implementation barriers
Lipoprotein(a) levels in a population with clinical atherosclerotic cardiovascular disease in the United States: A subanalysis from the Lp(a)HERITAGE study
No full textBACKGROUND: Elevated lipoprotein(a) (Lp[a]) is the most common inherited dyslipidemia that is independently and causally associated with increased atherosclerotic cardiovascular disease (ASCVD) risk. However, data from diverse populations with ASCVD are lacking.
OBJECTIVE: To evaluate Lp(a) levels in a diverse, contemporary United States (US) population with ASCVD, stratified by race, ethnicity, and sex.
METHODS: Lp(a)HERITAGE (NCT03887520) was a multicenter study that estimated the prevalence of elevated Lp(a) in adults (18-80 years) with ASCVD. US participants with Lp(a) measured in nmol/L pre- or post-enrollment were included in this subanalysis. This study was descriptive; therefore, no statistical comparisons were made.
RESULTS: Of all US participants, 14% had an Lp(a) measurement pre-enrollment. This subanalysis included 7679 US participants with Lp(a) measurements in nmol/L (80.5% White; 66.4% male; mean age 63.8 years [standard deviation ± 9.7]). Median Lp(a) was \u3e 2.5-fold higher in Black participants (132.0 nmol/L; IQR, 57.1-239.6) vs the overall population (52.1 nmol/L; IQR, 15.7-167.8), and higher in females compared with males (69.4 nmol/L; IQR, 20.1-194.7 vs 45.6 nmol/L; IQR, 14.0-152.6, respectively). Lp(a) levels ≥ 125 nmol/L were more prevalent among Black (52.0%) and female (38.9%) participants vs the overall population (33.3%).
CONCLUSION: In US Lp(a)HERITAGE participants, only 14% had an Lp(a) measurement pre-enrollment, despite having ASCVD. One-third of participants demonstrated Lp(a) levels ≥ 125 nmol/L, the threshold for high ASCVD risk, which was higher among Black (1/2) and female (2/5) participants, suggesting a greater need for Lp(a) testing in these groups to inform ASCVD risk mitigation
Carotid artery stenting with open vs closed stent cell configurations in the CREST-2 Registry.
No full textBACKGROUND: Intra-procedural atheroembolization during carotid artery stenting (CAS) can be reduced through careful patient selection, consideration of vascular anatomy and lesion characteristics, operator and institutional experience, peri-procedural antithrombotic and antiplatelet therapy, and use of embolic protection. However, CAS can also result in stroke as the stent is deployed and embolic protection withdrawn. The free-cell area of most closed-cell stents is \u3c5 mm(2), and ≥5 mm(2) for open-cell stents. The larger area may permit escape of more atheromatous debris. Comparisons of clinical outcomes between closed-cell and open-cell stents have been inconclusive. OBJECTIVE: The aim of this study is to compare clinical outcomes associated with CAS using open-cell versus closed-cell stents. METHODS: The CREST-2-Registry (C2R) enrolls asymptomatic and symptomatic patients for whom CAS is favored because of high risk for surgery or patient preference. C2R implements operator- and site-credentialing, careful lesion selection, and standardized procedural protocols. Patient characteristics, procedural details, and outcomes are recorded. Interventionists may use FDA-approved devices including open-cell stents (Rx Acculink [Abbott Vascular], Precise Pro Rx [Cordis-Cardinal Health], and Protégé Rx [Medtronic/Covidien]), or closed-cell stents (XACT [Abbott Vascular] and Wallstent Monorail Endoprosthesis [Boston Scientific]. Multivariable logistic regression was used to assess relate stent cell configuration to peri-procedural (30-day) stroke-or-death (SD). RESULTS: Of 5,307 procedures performed by 163 interventionists across 101 clinical centers, 2,054 (38.7%) received open-cell stents, and 3,253 (61.3%) received closed-cell stents. In the periprocedural period, 91 patients (1.7%) experienced a stroke (3 were fatal), and 16 patients died without experiencing strokes (0.4%). After adjusting for age, sex, symptomatic status, and case urgency, and for effect-modification by indication, periprocedural stroke-or-death (SD) was significantly higher when an open-cell stent was placed in a primary lesion compared to closed-cell stents (3.5 events per 100 procedures using open-cell stents [95% CI 2.6, 4.7] vs 2.2% [1.6, 3.0] using closed-cell stents, Odds Ratio 1.59 [1.13, 2.23], p\u3c0.01). Periprocedural SD was not significantly different between stent types when placed in a restenotic lesion (1.2% [0.4, 3.3] using open-cell stents vs 4.0% [2.2, 7.2] using closed-cell stents, OR 0.31 [0.09, 1.01], p=0.052). CONCLUSIONS: Stent design influences periprocedural stroke or death in carotid stenting. Closed-cell stents are associated with a lower event rate when treating primary atherosclerosis, but not in the setting of restenosis
Protocolised Management of Acute Myocardial Infarction Complicated by Cardiogenic Shock in Australia-Initial Experience From a Hub-and-Spoke Model.
No full textBACKGROUND: Acute myocardial infarction complicated by cardiogenic shock (AMICS) confers short-term mortality of 40%-50%. Protocolised network management of AMICS patients as part of a hub-and-spoke model supported by upstream mechanical circulatory support (MCS) is gaining traction globally to treat AMICS.
METHOD: We conducted a prospective multicenter study in Melbourne, Australia describing our 5-year experience utilizing a protocolised hub-and-spoke model of care for patients with AMICS supported by planned upstream use of Impella CP (Abiomed, Danvers, MA).
RESULTS: From December 2019 to August 2024, 31 patients were treated for AMICS with Impella MCS support. Median age was 60 years and 87% were males. ST-elevation myocardial infarction accounted for 84% of presentations, and 29% were complicated by cardiac arrest. The majority of patients treated were in SCAI-CSWG stage D (52%), and stage C (26%) shock. Upstream Impella prior to PCI occurred in 84% of patients. The 30-day survival rate was 74%. An adverse event occurred in 39% of patients. Device-related complications were due to hemolysis (32%) and arrhythmia (3%). Escalation of MCS support was required in five patients (16%). Multivariate analysis identified patients requiring transfer to the hub center prior to revascularisation as an independent predictor of mortality (OR 13.2 [1.34-129.3] p = 0.027).
CONCLUSION: In this first protocolised hub-and-spoke model of care for AMICS supported by planned upstream use of Impella in Australia, 30-day survival was high compared to published historical rates. Patient and device-related complication rates were low. Expansion of the hub-and-spoke model for the treatment of AMICS appears warranted
Gender and Racial Differences in the Overvaluation of Shape, Weight, Excess Skin, and Psychosocial Correlates Following Bariatric Surgery
No full textBACKGROUND: Overvaluation of shape and weight (OSW) is a risk factor for psychopathology in those who have undergone bariatric surgery, and overvaluation of excess skin (OES) may present similar psychological risks. Identifying potential gender and racial differences in post-surgical OSW and OES, and their associations with psychosocial outcomes, may inform more individualized assessment and treatment for those who have undergone bariatric surgery.
METHODS: In this cross-sectional study, individuals up to 4 years post-bariatric surgery completed an online survey of various psychosocial outcomes. Overvaluation was examined via the shape and weight overvaluation subscale of the Eating Disorders Examination Questionnaire (EDE-Q), and a modified item was used to assess the overvaluation of excess skin. Quality of life (QOL), depression, and anxiety symptoms were also examined. Gender and racial differences in OSW and OES were examined. Correlations were obtained between OSW/OES, QOL, and psychological symptoms among gender and racial groups.
RESULTS: Of 735 participants, women endorsed significantly greater OES than men (p = .008). There were no significant gender differences in OSW. White patients endorsed greater OSW than Black patients (p \u3c .001), and there were no racial differences in OES. OSW and OES were inversely correlated with QOL among all groups. OSW and OES were positively associated with anxiety and depressive symptoms among both racial groups and women.
CONCLUSION: Women may be at greater risk for OES than men, while White patients may be at increased risk for OSW. However, OSW/OES related to poorer QOL in all groups, and greater psychological symptoms in women
Role of Embolic Protection in Percutaneous Coronary Intervention Without Saphenous Venous Graft Lesions in ST-Segment-Elevation Myocardial Infarction: A Systematic Review and Meta-Analysis
No full textINTRODUCTION: Embolic protection devices (EPDs) are catheter-based devices that can be used to capture atherosclerotic remnants released during percutaneous coronary intervention (PCI). We aim to study the efficacy and safety of EPDs in PCIs without saphenous vein grafts (SVGs) in ST-segment-elevation myocardial infarction (MI).
METHODS: Three electronic databases of MEDLINE, Web of Science, and Embase were searched from inception to April 10, 2024, to identify relevant randomized controlled trials that compared outcomes of patients subjected to EPD during PCI with a control group where EPDs were not utilized. The primary outcome was 30-day all-cause mortality. Secondary outcomes were major adverse cardiovascular and cerebrovascular events at 30 days, post-PCI thrombolysis in MI grade 3 flow attainment, ST-segment resolution at 90 minutes post-procedure, and postprocedure angiographically detectable signs of distal embolization. The effect estimates of outcomes were assessed using risk ratio (RR) with a 95% confidence interval (CI). Random-effects meta-analysis was conducted using the restricted maximum likelihood method, given that the interstudy variance was inevitable.
RESULTS: We included 3 randomized controlled trials enrolling 741 patients (age, 61.6 ± 12.15 years; 22% females) undergoing PCI without SVG lesions. As opposed to the control group, the use of EPD did not yield a significant effect on all-cause mortality [RR, 0.76 (95% CI, 0.31-1.86); I 2 = 0%], major adverse cardiovascular and cerebrovascular events [RR, 0.66 (95% CI, 0.34-1.27); I 2 = 0%], post-PCI thrombolysis in MI 3 flow [RR, 1.18 (95% CI, 0.86-1.62); I 2 = 77%], and ST-segment resolution at 90 minutes post-procedure [RR, 1.05 (95% CI, 0.90-1.22); I 2 = 0%]. However, EPD significantly decreased angiographically detectable signs of distal embolization [RR, 0.60 (95% CI, 0.36-0.99); I 2 = 0%].
CONCLUSIONS: EPD significantly reduced angiographically detectable signs of distal embolization in PCI without SVG lesions in ST-segment-elevation MI though there were no clinical signs of improved flow or mortality. Further trials are necessary to thoroughly evaluate the potential benefits and requirements of EPD usage in such procedures
Short and long duration testosterone treatments induce reversable subfertility in female mice using a gestational model of gender-affirming hormone therapy
No full textSTUDY QUESTION: How does testosterone gender-affirming hormone therapy (T-GAHT) impact breeding success in female mice?
SUMMARY ANSWER: T-GAHT causes reversible subfertility in female mice and persistent changes to reproductive tract anatomy, gene expression, and hormone receptors.
WHAT IS KNOWN ALREADY: Adult female mice implanted with capsules containing 10 mg of testosterone mimic many aspects of reproductive phenotypes of T-GAHT patients, who may desire future gestation while pausing T-GAHT. In mice, oocytes retrieved from T-GAHT mice had decreased IVF rates, and T cessation prior to stimulation improved these outcomes. However, the effects of T-GAHT on breeding have not been examined.
STUDY DESIGN, SIZE, DURATION: Adult female CD1 mice were subcutaneously implanted with capsules containing 10 mg of testosterone or blank controls. In separate studies, capsules were removed after 6 (\u27short\u27) or 12 weeks (\u27long\u27 n = 15/group), then mice were paired with proven-breeder CD1 males. Breeding pair success and pup development (15-20/group) were measured for first and second litters, then terminal measurements were taken from dams and their adult offspring (10/group).
PARTICIPANTS/MATERIALS, SETTING, METHODS: The reproductive success of explanted T-GAHT and control mice was investigated by pairing them with proven-breeder CD1 males. Regular observations of dams and litters enabled analysis of fertility and the development of male and female pups for two litters. Terminal measures for dams and/or adult offspring focused on endpoints tied to reproductive tract function and gestation, including reproductive hormones, vaginal cytology, sperm analysis and ovarian and uterine anatomy, histology, and gene expression.
MAIN RESULTS AND THE ROLE OF CHANCE: All but one T-GAHT dams gave birth, but the time between pairing and their first birth was longer than controls after long (22.3 ± 1.3 days vs 24.5 ± 3.1) and short (23.2 ± 1.4 days vs 25.5 ± 4) treatments. Dams given long T-GAHT treatment had fewer pups in their first litters (11.9 ± 2.7 pups vs 7.8 ± 3.1) but pup number was unaltered after short treatment (11.5 ± 2.4 pups vs 11.4 ± 3.7). Further, offspring from first litters displayed accelerated puberty. Fertility differences and offspring developmental effects were absent for second gestations and litters. Despite fertility rescue, several anatomical, genetic, and histological changes persisted in T-GAHT dams after two litters. Offspring reproductive system outcomes were not significantly altered once dam fertility was restored. This study powerfully demonstrates a subfertile phenotype in T-GAHT-treated animals that is rescued over time and identifies gonadotropin and steroid hormone signaling as potential mechanisms for further investigation.
LARGE SCALE DATA: No large-scale data were generated in this study.
LIMITATIONS, REASONS FOR CAUTION: Significant effects of T-GAHT on dam terminal measures may be unrelated to subfertility, and similar endpoints must be examined during the subfertile period to identify and fully understand their roles in T-GAHT-dependent reproductive changes.
WIDER IMPLICATIONS OF FINDINGS: The assumption that T-GAHT causes irreversible damage to reproduction has harmfully informed public opinion, medical practice, and government policies. The finding in T-GAHT mice that fertility and offspring outcomes are not permanently impacted are of translational relevance and opens avenues to be tested first in non-human primate models and then humans.
STUDY FUNDING/COMPETING INTEREST(S): NIH R01 HD098233, NIH T32 DK071212. The authors declare no competing interests
Functional changes to Achilles tendon and enthesis in an adolescent mouse model of testosterone hormone therapy
No full textPURPOSE/AIM: Some youth seek puberty suppression to prolong decision-making prior to starting hormone therapy to help align their physical sex characteristics with their gender identity. During peripubertal growth, connective tissues such as tendon rapidly adapt to applied mechanical loads (e.g. exercise) yet if and how tendon adaptation is influenced by sex and gender-affirming hormone therapy during growth remains unknown. The goal of this study was to understand how pubertal suppression followed by testosterone influences the structural and functional properties of the Achilles tendon using an established adolescent mouse model of testosterone hormone therapy.
MATERIALS AND METHODS: C57BL/6N female mice were assigned at postnatal day 26 to the following experimental groups: control (vehicle treated), gonadotropin release hormone analogue (GnRHa) treatment alone to delay puberty, testosterone (T) alone after puberty, or delayed puberty with T treatment (i.e. GnRHa followed by T).
RESULTS: We found that pubertal suppression using GnRHa with and without T, as well as treatment with T alone post-puberty, increased the ultimate load of tendon in female mice. Additionally, we found that GnRHa, but not T treatment resulted in a significant increase in cell density at the Achilles enthesis.
CONCLUSIONS: These findings demonstrate that delayed puberty and T have no negative influence on structural or functional properties of mouse tendon