6-months Follow-up Research Articles

Acceptance and commitment therapy as a transdiagnostic approach to adolescents with different anxiety disorders: study protocol.

Adolescence increases vulnerability to mental ill-health, particularly anxiety disorders like Social Anxiety Disorder (SAD) and Generalized Anxiety Disorder (GAD). Still, the understanding of Psychological Flexibility/Inflexibility (PF/PI) as a transdiagnostic framework relevant to explaining these difficulties and the efficacy of Acceptance and Commitment Therapy (ACT) in addressing adolescent SAD and GAD remains limited. Hence, this study has two aims: examining the role of PI/PF on adolescents' mental health and assessing ACT's efficacy for adolescent SAD and GAD. We will collect data from 400 community adolescents and employ network analysis to explore connections between PI/PF processes, anxiety, and flourishing. We will also investigate pathways linking PI/PF processes with flourishing and anxiety across samples (clinical SAD, clinical GAD, and mentally healthy groups), expecting to find similar patterns. Furthermore, a Randomized Controlled Trial with three groups (control, SAD experimental and GAD experimental), each comprising 29 participants, and four assessment moments (pre- and post-intervention and 3- and 6-months follow-up) will be conducted. Similar improvements are anticipated in both experimental groups, driven by changes in PI/PF processes. Findings from this work will provide valuable evidence to PI/PF as accurate conceptualizations of human suffering and expand the transdiagnostic application of ACT to adolescents with anxiety disorders.

A potential platform for future vaccine trials identifies high incidence of symptomatic and asymptomatic influenza infection among children aged 6-23 months in South Africa.

Approaches for determining whether influenza vaccination prevents infection, attenuates illness, or both, are important for developing improved vaccines. We estimated influenza infection incidence, and evaluated symptom ascertainment methodologies in children to inform future vaccine trial design. We conducted a prospective cohort study among children aged 6-23 months from May-October 2022. Study nurses collected symptom and temperature data and mid-turbinate nasal swabs twice-weekly irrespective of symptoms; caregivers entered symptom data daily and collected nasal swabs weekly. Samples were tested for influenza using PCR. Of 230 healthy, screened children, 93 were enrolled of whom 87 (94%) completed 6-months follow-up. 95% (4245/4476) of scheduled nurse, 90% (2045/2276) of caregiver swabs, 99% (92/93) of baseline blood collections and 67% (9245/13768) of scheduled symptom diaries were completed. PCR-confirmed influenza incidence was 65% (60/93) for ≥1 infection; 11 (18%) individuals had 2 and 1 (2%) had 3 episodes. Of 73 episodes, 55 (75%) had ≥1 symptom and 37 (51%) had fever (measured and/or reported). Median infection duration was 7 days (interquartile range 4-9). Human RNase P gene was detected in 99% (2032/2045) of caregiver-collected swabs, through which 5 additional episodes were identified. Per episode, caregiver's diaries of reported and measured fever were 19%(25/73,34%) and 11%(15/73,21%) higher than nurse-reported (11/73,15%) and -measured fevers (7/73,10%), respectively. The incidence of influenza infection was high and mainly symptomatic suggesting that this platform could be suitable for future trials of vaccine efficacy and correlates of protection against infection and illness in children.

SURG-32. OPTIMIZING TUMOR TREATING FIELDS THERAPY FOR FIRST RECURRENT GLIOBLASTOMA WITH SKULL REMODELING SURGERY. FINAL RESULTS FROM OPTIMALTTF-2, A MULTI-CENTER, RANDOMIZED, CLINICAL TRIAL

Abstract Studies indicate that increasing the electric field intensity of Tumor Treating Fields therapy (TTFields) may prolong survival for glioblastoma (GBM) patients. Skull remodeling surgery (SR-surgery) aims to increase electric field intensity by 30-100% by removing the poorly conductive skull, and OptimalTTF-1 (pilot trial) concluded that SR-surgery was safe with a median overall survival (mOS) of 15.5 months for first recurrence GBM (rGBM). OptimalTTF-2 is a 1:1 randomized, comparative, multi-center, investigator-initiated, interventional clinical phase 2 trial investigating the efficacy and safety of TTFields and standard of care with or without SR-surgery for 84 rGBM subjects, with a planned interim analysis after enrollment of the first 52. Randomization is solely for SR-surgery and involves five burr holes of 15mm each in diameter, located in the skull between the tumor and the transducer arrays. The trial was nationwide in Denmark and active from 2020-2024. Major eligibility criteria include age ≥18 years, histopathological confirmed first recurrence of supratentorial GBM, and KPS ≥70. The primary endpoint is OS after 12 months (OS12), while secondary endpoints include PFS, QoL, ORR, QoL, KPS, steroid dose, and toxicity. The trial recruited 58 subjects and 52 had follow-up of 12-months or longer. Randomization was balanced and both arms had a median age of 59 years and no statistical difference in prognostic markers. Intent-to-treat analysis revealed the following for the intervention and control respectively, OS12 55% [95%CI 37-74%] vs. 45% [95%CI 27-64%](p=0.4), mOS 12.2 [7.9-19.1,95%CI] vs. 11 [6.5-17.1, 95%CI] months, and PFS 4.5 [3.4-9.5,95%CI] vs. 3.5 [3-6.4,95%CI] months. All the secondary outcomes were statistically insignificant. The trial was terminated early after interim analysis indicated no survival benefit from SR-surgery and a conditional power calculation that showed a low expected survival benefit for the planned cohort of 84 subjects. Post hoc analysis examining potential negative outcome modifiers is needed.

Is strength and power training targeting hip and knee muscles superior to strength training in individuals with patellofemoral pain? Proof of concept study

The purpose was to determine whether the benefits of a muscle strength and power training program are superior to those achieved with muscle strength training alone in people with patellofemoral pain (PFP). Thirty-seven individuals with PFP (25.86 ± 7.62 years) were randomly assigned to a strength and power training group (n = 18) or strength training group (n = 19). Primary outcomes were pain intensity and physical functioning. Secondary outcomes were kinesiophobia, quality of life, maximal isometric torque and rate of torque development of the hip and knee and self-perception of recovery. Primary outcomes were measured at baseline, after six weeks, after 12 weeks and at three, six- and 12-months follow-ups. Secondary outcomes were measured at baseline and after 12 weeks. The significance level was 0.05. After interventions, no significant differences were found between groups for primary or secondary outcomes. No difference between groups were found for pain or physical functioning at the other assessment times. Results of this study indicated that addition of power exercises to strength training for hip and knee muscles did not result in superior benefits compared to strength training alone.

Effect of interdisciplinary obesity care on metabolic markers and body weight in people with type 2 diabetes in a rural setting: A randomised controlled trial.

Management of type 2 diabetes includes medications that can unintentionally increase obesity and insulin resistance. This unblinded, single-centre, randomised controlled trial focused on rural Australian adults with type 2 diabetes (aged 18-75 and body mass index [BMI] >30 kg/m2), measuring the effectiveness of a tailored interdisciplinary obesity care approach compared with usual diabetes care. Led by a nurse practitioner with allied health support (dietitian ± psychologist and physiotherapist), the bariatric treatment involved reducing weight-gaining medications, a 500-calories/day deficit, an unsupervised exercise program emphasising movement/strength and psychotherapy, 3-monthly to 24-months with support phone calls at weeks 2, 4, 8 and 10. Outcomes from the 224 (113 intervention/111 control) participants were differences in biomedical and physical markers within- and between-groups estimated using multivariate mixed-effects linear regression between recruitment and 6-monthly follow-ups. Greater change occurred in intervention compared with control groups at 12 and 24 months in mean: body weight (-5.9 kg [95% confidence interval, CI: -8.53, -3.23] and -9.0 kg [95% CI: -13.2, -4.77]); BMI (-2.03 kg/m2 [95% CI: -2.92, -1.15] and -3.51 kg/m2 [95% CI: -4.93, -2.08]); and glycated haemoglobin (-0.26% [95% CI: -0.69%, 0.18%] and -0.63% [95% CI: -1.17%, 0.08%]). The control group showed a significant increase in mean leptin level, resulting in a between-group difference (-27.1 [95% CI: -42.7, -11.5]). Lipids and blood pressure differences were inconclusive, while exploratory analysis showed greater decline in estimated glomerular filtration rate in the control group. The interdisciplinary obesity approach, compared with usual diabetes care, resulted in sustained weight loss and improved diabetes control over 2 years. Trial registration number: ACTRN12622000240741.

A Novel Unilateral Bi/Multi-Portal Endoscopic Transforaminal Interbody Fusion Utilizing Uniaxial Spinal Endoscope Instead of Arthroscope: Technical Note and Preliminary Clinical Results.

Currently, traditional UBE surgery, which is based on arthroscope, has been increasingly employed for complex lumbar degenerative diseases. However, this approach is associated with complications such as intraoperative dural sac tears, nerve root injuries, and postoperative epidural hematomas. In response to these challenges, we propose a novel technique utilizing uniaxial spinal endoscope to replace arthroscope-Unilateral Bi/Multi-Portal Endoscopy (UME). This new method has successfully treated complex lumbar disc herniation and spinal stenosis, resulting in improved postoperative outcomes and a reduction in complications. Based on the previous findings, we utilized uniaxial spinal endoscopy as the primary operating method, with the assistance of multi-portal endoscopic techniques (UME-TLIF), to perform transforaminal lumbar interbody fusion. The feasibility and preliminary clinical results have been presented in this paper. A total of 18 patients (8 men and 10 women, aged 52.6 ± 15.29 years) diagnosed with lumbar degenerative diseases, such as giant lumbar disc herniation, severe lumbar spinal stenosis, or lumbar spondylolisthesis, were included in this study from January 2022 to March 2023. Various parameters including operation time, ambulatory time, intraoperative fluoroscopy times, hospitalization days, and complications were recorded during the perioperative period. Clinically relevant symptoms were evaluated and documented 1, 3, 6, and 12 months postoperatively. Visual analogue scale (VAS) scores for lower back pain and leg pain, as well as the Oswestry disability index (ODI), were measured. The extent of lumbar interbody fusion was assessed using lumbar X-ray and CT scans at the 12-months follow-up. MRI was performed to assess the degree of nerve decompression in patients at the same time points. The paired t-test or Wilcoxon signed-rank test were used as statistical methods. The single-segment UME-TLIF procedure had an average operation time of 211 ± 53.3 min, and the average number of X-rays taken during the operation was 11.78 ± 5.32. Patients were able to walk and perform functional exercises approximately 35.11 ± 8.41 h post-surgery, and the average duration of hospital stay was 8.5 ± 2.27 days. The VAS and ODI values at each time point post-surgery were significantly lower than the respective pre-surgery values (p < 0.05). Two patients developed postoperative sensory disturbances which significantly improved with conservative treatment. Furthermore, a follow-up CT scan conducted 12 months post-surgery showed 100% fusion rate of the surgical segments in all patients. UME-TLIF is an endoscopy-assisted fusion procedure that minimizes muscle damage in patients and allows early rehabilitation. This technique broadens the surgical applications of uniaxial spinal endoscope as a surgical tool, particularly benefitingpatients diagnosed with severe lumbar disc herniation and lumbar instability.

Neutrophilic inflammation in sputum or blood does not define a clinically distinct asthma phenotype in ATLANTIS

IntroductionNeutrophilic asthma has been suggested to be a clinically distinct phenotype characterized by more severe airflow obstruction and higher exacerbation risk. However, this has only been assessed in few and smaller studies, using different cut-offs to define neutrophilia, and with conflicting results.We used data from ATLANTIS, an observational longitudinal study including a large number of patients with asthma and healthy controls.AimTo examine if neutrophilic inflammation, either in sputum or blood, is more prevalent in asthma and whether it correlates with disease severity.MethodsATLANTIS included 773 asthma patients, with blood collected from 767 (99%) and sputum from 228 patients (30%). Data were available from 244 healthy controls, all providing blood and 126 (52%) providing sputum. Asthma patients were characterized including parameters of large and small airways disease at baseline and after 6- and 12-months follow-up. Sputum and blood neutrophilia were defined as values exceeding the upper quartile in asthma patients.ResultsThe prevalence of sputum neutrophilia did not differ between asthma patients and healthy controls. Asthma patients with sputum neutrophilia did not display more severe symptoms, large or small airways disease, or more frequent exacerbations. Blood neutrophilia was more common in asthma and associated with higher BMI, female sex, current smoking and systemic corticosteroid use. Patients with blood neutrophilia had a statistically significant, but small, increase in RV/TLC. Blood neutrophilia was not associated with large or small airways disease, or exacerbation risk.ConclusionSputum and blood neutrophilia do not define a distinct clinical phenotype in asthma.

Serum anti-NMDA receptor antibodies are linked to memory impairment 12 months after stroke.

Patients suffering from strokes are at increased risk of developing post-stroke dementia. Serum anti-NMDA receptor autoantibodies (NMDAR1-abs) have been associated with unfavorable post-stroke outcomes. However, their effect on specific cognitive domains remains unclear. We used data from the prospective multicenter DZNE-mechanisms after stroke (DEMDAS) cohort, and measured NMDAR1-abs in serum at baseline. Cognitive function was assessed with a comprehensive neuropsychological test battery at 6- and 12-months follow-up. We employed crude and stepwise confounder adjusted linear and logistic regression models as well as generalized estimating equation models (GEE) to determine the relevance of NMDAR1-abs seropositivity on cognitive function after stroke. 10.2% (58/569) DEMDAS patients were NMDAR1-abs seropositive (IgM:n = 44/IgA:n = 21/IgG:n = 2). Seropositivity was not associated with global cognitive impairment after stroke. However, NMDAR1-abs seropositive patients performed lower in the memory domain (βadjusted = -0.11; 95%CI = -0.57 to -0.03) and were at increased risk for memory impairment (ORadjusted = 3.8; 95%CI = 1.33-10.82) compared to seronegative patients, 12 months after stroke. Further, NMDAR1-abs were linked to memory impairment over time in GEE from 6- to 12-months follow-up (ORadjusted = 2.41; 95%CI = 1.05-5.49). Our data suggests that NMDAR1-abs contribute to memory dysfunction 1 year after stroke while not affecting other cognitive subdomains. Hence, antineuronal autoimmunity may be involved in distinct mechanisms of post-stroke memory impairment. Clinical trial name and registration number: The Determinants of Dementia After Stroke (DEMDAS; study identifier on clinical trials.gov: NCT01334749).

Sinus rhythm maintenance and the changes of echocardiographic parameters in patients with late persistent atrial fibrillation at 6 months after direct current cardioversion

Abstract Background Late persistent non-valvular atrial fibrillation (AF), with a duration of its episode ≥90 days and up to 12 months, is considered a distinct persistent AF entity, which might possess substantial differences as compared to its early persistent pattern (up to 3 months) in terms of myocardial remodeling and its reversibility after cardioversion. Purpose To study the changes of echocardiographic parameters in patients with non-valvular late persistent AF with respect to sinus rhythm (SR) maintenance at 6 months after successful direct current cardioversion (DCCV). Methods The cohort single-center study enrolled 59 late persistent AF patients, who underwent a successful elective DCCV. At 6-months follow-up, patients were subdivided into the groups regarding SR maintenance: 32 (54 %%) patients with a maintained SR (G1), and 27 (46 %) patients with a failure to maintain SR (G2). The parameters of myocardial remodeling and function were evaluated by transthoracic (TTE) and transesophageal echocardiography (TEE) baseline (by TTE and TEE) and at 6-months follow-up (by TTE). Results TTE data from G1 patients, in contrast to G2, suggested better baseline status of left heart chambers, particularly the lower diameter of left atrium (LA), left ventricular (LV) end-diastolic and end-systolic volumes and higher LV systolic function (by LV ejection fraction [EF]). According to the TEE data, G2 (vs. G1) was characterized by more prevalent cases of LA spontaneous (echo) contrast (41 % vs. 15 %, respectively; p=0,042) and LA appendage flow velocity ≤40 cm/s (82 % vs. 53 %, respectively; p=0,022). At 6-months follow-up TTE, G1 patients, as opposed to G2, demonstrated a better profile of echocardiographic parameters, namely a lower LA diameter, LA and right atrium (RA) volumes, along with less advanced LV remodeling and higher LV EF. TTE data from G1 at 6-months follow-up after DCCV suggested the reverse remodeling of both atria, namely the decrease of LA diameter, LA volume and its index (Fig. 1), as well as RA volume and its index. Moreover, G2 demonstrated a decline in LV systolic function, in particular the rise of LV end-systolic volume and decrease of LV EF (Fig. 2), as compared to G1. Furthermore, at 6-months follow-up, G2 patients presented with more advanced severity of PH and tricuspid regurgitation, in comparison with G1. Conclusions Late persistent AF patients with a SR maintenance at 6-months follow-up after successful DCCV presented a better baseline profile of myocardial remodeling and systolic function. The SR maintenance at 6-months follow-up after DCCV was associated with the reverse remodeling of left heart chambers (LA and LV) and RA. On the contrary, a failure to maintain SR in late persistent AF patients was associated with a deterioration in LV systolic function, and more advanced PH and tricuspid regurgitation.

Credentialed pharmacist-led home medicines reviews targeting treatable traits and their impact on health outcomes in people with chronic obstructive pulmonary disease: a pre- and post-intervention study.

Patients with chronic obstructive pulmonary disease (COPD) should engage in self-management strategies targeting behavioural traits and lifestyle risk-factors for optimal outcomes. To evaluate the impact of credentialed pharmacist-led home medicines review (HMR) targeting treatable traits (TTs) on health outcomes in COPD in primary care. A pre- and post-intervention study was nested within a cluster-randomised controlled trial. A total of 81 participants with COPD from 21 Australian general practices received an HMR with a credentialed pharmacist targeting TTs. Changes in health outcomes at 6 and 12months from baseline were assessed. Ten TTs were assessed and targeted during the HMR. At baseline, no-one had a written action plan for managing exacerbations, and medication adherence was sub-optimal in 85% of patients. Additionally, 53% of participants demonstrated inadequate inhaler device technique, while 52% were current smokers. At 6-months follow-up, significant improvements were observed in health-related quality of life (St. George's Respiratory Questionnaire score = 34.6 versus 39.1 at baseline, p = 0.006), health status (COPD Assessment Test score = 12 versus 16, p = 0.002), anxiety (Hospital Anxiety and Depression Scale (HADS)-Anxiety score = 2.0 versus 5.0, p < 0.001), depression (HADS-Depression score = 1.0 versus 5.0, p < 0.001), self-reported smoking (47% versus 51.9%, p = 0.031) and treatment adherence (Tool for Adherence Behaviour Screening score = 12.5 versus 10.0, p = 0.002). At 12-months: health status, anxiety, depression, smoking abstinence and adherence to treatment, continued to show statistically significant improvements compared to baseline measurements. HMRs targeting TTs improved health outcomes in people with COPD. Credentialed pharmacists in primary care can work alongside general practitioners to optimise COPD management.

Peer support interventions improve disease self-management after coronary heart disease diagnosis: a systematic review and meta-analysis

Abstract Background Patients with coronary heart disease (CHD) diagnoses often experience impacts on patient-reported outcomes (quality of life, depression, disease self-management and self-efficacy) at a time when secondary prevention is required. Peer support has proven benefits for these issues in many chronic conditions but synthesis of the evidence in CHD populations has not been undertaken. Purpose In this systematic review and meta-analysis, we aimed to explore the impact of peer support interventions on health-related quality of life, depression, anxiety, self-management and self-efficacy in CHD. Methods Electronic databases were searched from inception to November 2023 (MEDLINE, Embase, PsycINFO, CINAHL, Scopus, PubMed [non-MEDLINE], Web of Science, and the Cochrane Central Register of Controlled Trials). Randomised controlled trials (RCTs) evaluating peer support interventions (that enable experience sharing and/or support by others with the same condition) in populations with diagnosed CHD were eligible for inclusion. Risk of bias was assessed using the Cochrane risk of bias tool. Meta-analyses were undertaken in RevMan Version: 7.4.0 using the inverse variance method and a random effects model. Results In total, 16 papers reporting 14 unique RCTs were included. The total sample (n=1793) was 65% male with a mean age of 54.5±13.0 years. The diagnosis of the samples varied between studies, including coronary artery bypass graft(s), first time or newly diagnosed myocardial infarction and percutaneous coronary intervention. By 6-months follow-up, peer support interventions demonstrated no statistically significant improvements in health-related quality of life (SMD -0.38, 95% CI -1.84, 1.08), depression (SMD -0.09, 95% CI -0.26, 0.08) and anxiety (SMD -0.85, 95% CI -1.83, 0.14). Whereas, improvements occurred in disease self-management (SMD 1.49, 95% CI 0.66, 2.32) and self-efficacy in both short term (by 6-months, SMD 0.57, 95% CI 0.37, 0.77) and longer term (6-12 months, SMD 0.67, 95% CI 0.29, 1.05). Peer support interventions varied widely in format and several studies were of poor quality. Conclusion Peer support interventions benefit patient-reported outcomes of disease self-management and self-efficacy up to 6 and 12 months, but not for other patient reported outcomes after CHD diagnosis. More exploration is needed of content, delivery and focus of peer support interventions to maximise effectiveness for CHD secondary prevention.

Respective impact of bleeding and ischemic complications of mortality after percutaneous coronary interventions: substudy from the FRANCE-PCI registry

Abstract Background Patients undergoing percutaneous coronary interventions (PCI) remain at high risk of both bleeding and ischemic events, both burdened with high morbimortality. The respective impact of both type of complications in contemporary PCI, however, remains unclear. Purpose To evaluate and compare the respective impact of ischemic and bleeding complications on mortality after PCI Methods The FRANCE PCI is an ongoing registry of consecutive French patients undergoing PCI and monitored for one year thereafter. Patients presenting with complications after the index PCI were categorized as ischemic complications in case of stent thrombosis, myocardial infarction, stroke or unplanned revascularization, as hemorrhagic complications in case of bleeding BARC ≥3 or as ischemic and hemorrhagic when both types of events occurred in the same patients. The impact of ischemic and hemorrhagic complications on mortality was evaluated separately for the index hospitalization and the 12-months follow-up after hospital discharge, using multivariate logistic model and Cox proportional hazards model, respectively. The multivariate Cox model was developed using complications as time-dependent variables and estimating the hazard ratios (HRs) over 3 periods of time (0 to 8 weeks, 8 to 24 weeks, and 24 to 52 weeks). Consequently, the proportional hazard assumption, tested using the Schoenfeld test, was met for each period. Multiple imputations were performed for missing data on covariates. Results A total of 54,599 patients, with a median age of 69 [60.0-78.0] years, 75.0% male, underwent PCI in 30 centers between 2014 and 2020, in an elective setting for 47% of the cases. During the index hospitalization, an ischemic and hemorrhagic complications occurred in 610 (1.1% 95%CI 1.0-1.2) and 531 (1.0% 95%CI 0.9-1.1) patients, respectively, while the mortality rate was 2.1% 95%CI 2.0-2.2. The association between ischemic, hemorrhagic and ischemic and hemorrhagic events with mortality was aOR 8.4 95%CI 6.4-10.9, aOR 10.3 95%CI 8.1-13.2 and aOR 13.2 95%CI 7.0-24.7, respectively. Among the 51,738 patients alive and not lost-to-follow-up after discharge, an ischemic and hemorrhagic complications occurred in 2,727 (5.3% 95%CI 5.1-5.5) and 1,022 (2.0% 95%CI 1.9-2.1) patients, respectively, while the mortality incidence was 3.8% 95%CI 3.6-4.0. The associations between ischemic, hemorrhagic and ischemic and hemorrhagic events with mortality according to the periods of time are detailed in Table 1 and Figure 1. Conclusion Both ischemic and hemorrhagic complications after PCI are associated with increased risk of mortality. The risk is particularly increased during the early period after the index PCI and diminishes over time, albeit faster after ischemic complications alone, compared to hemorrhagic events alone or the association of ischemic and hemorrhagic complications.

Effective tricuspid regurgitation reduction is associated with renal improvement and reduced heart failure hospitalization.

Several studies have demonstrated an association between tricuspid regurgitation (TR) and organ dysfunction including hepatic and renal insufficiency. Improvement of liver function following transcatheter edge-to-edge repair (T-TEER) has already been linked to reduction of venous congestion due to TR reduction. This study analyzes whether TR-reduction using T-TEER is also associated with improved renal function. The TRIC-ULM registry includes 92 selected patients undergoing T-TEER between March 2017 and May 2023. Estimated glomerular filtration rate (eGFR) improvement was evident in 53 patients (57%) at 3-months follow-up (FU) and defined by FU eGFR > baseline eGFR. Median age was 80 [interquartile range 75-83] years, pre- and postinterventional TR grades were 4 [3-5] and 1 [1-2], baseline eGFR was 36 [30-53] ml/min and New Yeark Heart Association (NYHA) IV was evident in 15% of patients. Multiple logistic regression analysis revealed TR vena contracta reduction (Odds ratio (OR) 1.35 [95% CI: 1.12-1.64] per mm, p = 0.002) and reduced preinterventional tricuspid annular plane systolic excursion (TAPSE) [OR 0.89 (95% CI: 0.79-0.99) per mm, p = 0.033] to independently predict renal improvement at FU. An eGFR improvement threshold of >9 ml/min was associated with reduced 1-year heart failure hospitalization rates [adjusted hazard ratio 0.22 (95% CI: 0.07-0.62) p = 0.005]. Effective tricuspid edge-to-edge repair is associated with improved renal function and reduced heart failure hospitalization. In patients without renal improvement at 3-months follow-up, residual tricuspid regurgitation should be reevaluated for reintervention.

Assessment of intraocular lens tilt and decentration after femtosecond laser-assisted and conventional cataract surgery at 12 months and beyond

PurposeTo compare long-term intraocular lens (IOL) decentration and tilt following femtosecond laser-assisted cataract surgery (FLACS) and conventional surgery using swept-source anterior segment ocular coherence tomography (SS-ASOCT).MethodsIn this retrospective cross-sectional study, all patients underwent FLACS or conventional cataract surgery. Those with a minimum of 12-months follow-up since surgery were included. Patients with surgical complications were excluded. Demographics, preoperative ocular measurements (axial length, anterior chamber depth), and postoperative measurements [corrected distance visual acuity (CDVA), autorefraction, keratometry, IOL type] were collected. Postoperative IOL tilt and decentration were compared using SS-ASOCT between patients with FLACS and conventional cataract surgery. Subgroup analysis was conducted to analyze tilt and decentration by haptic type (single-piece vs. three-piece).ResultsA total of 188 eyes were included [110 (58.5%) in the FLACS group and 78 (41.5%) in the conventional group]. No differences were observed between the FLACS and conventional groups regarding preoperative parameters. FLACS resulted in less IOL decentration compared to conventional cataract surgery (170 μm vs. 240 μm, p = 0.002). No statistically significant differences were observed between the FLACS and conventional groups in the magnitude and axis of IOL tilt. Both groups had a trend of IOL tilt toward the inferotemporal aspects. Moreover, no difference regarding postoperative CDVA, spherical equivalent, and keratometric astigmatism was observed.ConclusionsFLACS resulted in significantly better long-term IOL centration than conventional surgery with manual capsulotomy. No significant difference in IOL tilt or postoperative CDVA was observed between FLACS and conventional cataract surgery.

A stented elephant trunk procedure with retrograde cerebral perfusion for a rare type of pseudoaneurysm with an aberrant right subclavian artery.

Aberrant right subclavian artery (ARSA) is a rare congenital vascular anomaly that increases the risk of aortic dissection (AD). Although several treatment options for cases of AD with ARSA have been proposed, such as traditional surgery, thoracic endovascular aortic repair, and a hybrid procedure, a consensus regarding the optimal treatment strategy has not yet been established. And there are no reported cases of pseudoaneurysm combined with ARSA. A 44-year-old male was admitted with a 7-days history of chest pain. A physical examination was almost normal. Computed tomography angiography (CTA) showed an ARSA arose from the distal aortic arch and pseudoaneurysm located distal to the origin of the ARSA. The stented elephant trunk (SET) procedure with retrograde cerebral perfusion (RCP) was performed under moderate hypothermic circulatory arrest. The postoperative CTA demonstrated a well-perfused ARSA, left subclavian artery (LSA), left common carotid artery (LCCA), and right common carotid artery (RCCA), and occluded pseudoaneurysm with no endoleaks. He was discharged on postoperative day 9 and was doing well during his 6-months follow-up. With a smaller incision, a simple cannulation method, shorter surgical and circulatory arrest times, fewer blood transfusion requirements, and effective brain protection, the SET procedure with RCP can be a safe and feasible treatment option for complicated aortic arch anomalies with ARSA.

The effect of empagliflozin (sodium-glucose cotransporter-2 inhibitor) on osteoporosis and glycemic parameters in patients with type 2 diabetes: a quasi-experimental study.

Diabetic osteoporosis (DOP) is a metabolic disease that occurs in patients with diabetes due to insufficient insulin secretion. This condition can lead to sensory neuropathy, nephropathy, retinopathy, and hypoglycemic events, which can increase the risk of fractures. This study aimed to assess the effectiveness of Empagliflozin, a sodium-glucose cotransporter-2 (SGLT-2) inhibitor, in treating diabetic osteoporosis (DOP) and preventing fractures. This quasi-experimental study enrolled 100 patients with diabetic osteoporosis from February 2023 to February 2024. Participants were randomly assigned to an intervention group (n = 50) and a control group (n = 50). The intervention group received Empagliflozin in combination with symptomatic treatment, while the control group received only symptomatic treatment. The treatment duration was six months. Fasting blood glucose (FBG), 2-hour postprandial blood glucose (2h PG), glycosylated hemoglobin A1c (Hb A1c), bone mineral density (BMD), serum phosphorus and calcium concentration were measured after the intervention and the incidence of fracture was followed up for 12 months. The data were analyzed using SPSS 23. Descriptive statistics (mean, standard deviation, and percentage) and analytical methods (t test, Chi square) were also used to analyze the data. After six months of treatment, the intervention group exhibited significantly lower levels of FBG (P < 0.001), 2h-PG (P = 0.001), and HbA1c (P < 0.001) than the control group. Additionally, bone mineral density, serum phosphorus, and calcium levels were significantly higher in the intervention group (P < 0.001). After a 12-months follow-up, the incidence of fractures in the intervention group was 2%, while it was 16.33% in the control group (P < 0.05). Empagliflozin, when combined with symptomatic treatment, demonstrates a positive clinical effect in patients with diabetic osteoporosis. The treatment effectively improves blood glucose metabolism, bone mineral density, and phosphorus and calcium metabolism, ultimately leading to a significant reduction in the incidence of fracture.

The potential role of intracavernosal injection of platelet-rich plasma for treating patients with mild to moderate erectile dysfunction: A GRADE-Assessed systematic review and meta-analysis of randomized controlled trials.

Platelet-rich plasma (PRP) has shown positive effects on enhancing erectile function in animal studies. Human clinical trials are limited and provide contradictory results. This review aims to conduct a meta-analysis of the available Randomized controlled trials (RCT) to assess the efficacy of PRP in males with ED. A systematic review was carried out following the Cochrane Handbook of Intervention and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and registered in PROSPERO (CRD42023441655). A total of three RCTs were included in the analysis for a total of 221 patients with mild to moderate ED. The patients receiving PRP reported significantly better improvement of IIEFEF score during 1,3- and 6-months follow-up compared to the placebo group (mean difference [MD] 2.66, 95% confidence interval [CI] 1.48 to 3.83, p < 0.01; MD 2.11, 95%CI 0.13 to 4.09, p = 0.04; MD 2.99, 95%CI 1.79 to 4.19, p < 0.01). The pooled analysis indicated that attainment of minimally clinical important difference (MCID) was significantly higher in patients receiving PRP compared to the placebo group during one and 6-month follow-up (odds ratio [OR] 5.51, 95%CI 1.2 to 254, p = 0.03; OR 5.64, 95%CI 2.05 to 15.55, p < 0.01; respectively). Encouragingly, no major AEs were reported in all three trials in the PRP and placebo groups (p = 0.99). This review highlights the potential role of PRP in providing short-term improvement of erectile function parameters for up to 6 months in mild to moderate ED patients. Future RCTs with longer-duration follow-ups and more standardized treatment protocols are necessary to gain sufficient details on PRP's long-term effectiveness and safety.

A Comparative Study on the Efficacy of Group Positive Psychotherapy and Group Cognitive Behavioral Therapy on Flourishing, Happiness and Satisfaction with Life: A Randomized Controlled Trial

The present study examines the efficacy of Positive Psychotherapy (PPT) on psychological well-being, happiness, and satisfaction with life. We investigated people suffering from different kinds of depressive disorders, comparing it to Cognitive Behavioral Therapy (CBT). PPT is an empirically validated intervention targeting positive resources and personal strengths. It aims at amplifying well-being while also ameliorating the impact of symptoms. In a controlled two-center-study, we randomly assigned 92 out-patient participants with a DSM-IV diagnosis of major depressive disorder and/or Dysthymia to 14 sessions of manualized PPT or CBT group therapy. We assessed outcomes related to well-being using the Flourishing Scale, the Satisfaction with Life Scale, and the Positive Psychotherapy Inventory (PPTI). The PPTI represents the five components of Seligman’s PERMA-model of flourishing, encompassing positive emotions, engagement, positive relationships, meaning, and accomplishment. We took measurements before and after the intervention, and at a 6-months follow-up. Moreover, we considered a list of moderators that may impact the efficacy of PPT. PPT resulted in significant improvements in all measures, and these improvements remained stable for up to 6 months. Using 2 × 2 mixed-effects models (T1 vs. T2), we found significant interactions for all three main scales and two out of the five PPTI subscales. These interactions depicted significantly better outcomes for PPT at post-treatment. Regarding the follow-up (T1 vs. T3), we did not find significant interactions, and thus, there were no differences between the two therapies. No demographics or characteristics of the treatments were significant moderators. Summarized, these findings provide support for the effectiveness of PPT in increasing happiness, well-being, and quality of life. We can confirm that PPT is an additional tool for the enhancement of positive mental health.

Ensuring precision medicine for veterans with lung cancer: A randomized clinical trial.

178 Background: National guidelines recommend molecular testing for patients with non-small cell lung cancer, yet this is not routinely completed in practice. In prior work, we identified barriers to testing in the Veterans Affairs. First, physicians are unaware if and when testing has occurred. Second, patients are unaware of testing and the implications on treatment and clinical outcomes. In response, in collaboration with a Veteran and Caregiver Advisory Board, we created a multilevel intervention led by a peer volunteer who: 1) provides tailored education of molecular testing for 1 month for Veterans newly diagnosed with lung cancer and, 2) alerts clinicians via secure messaging if tumor samples have not been tested. We conducted this randomized clinical trial to assess whether the intervention improves patient knowledge of molecular testing and patient activation and increases receipt of molecular genomic testing compared with usual care. Methods: All veterans &gt;18 years old with a new diagnosis of any stage non-small cell lung cancer were eligible. Exclusions included inability to consent. All participants completed baseline assessments at randomization and at 1-month follow-up comprised of a 3-question validated precision medicine knowledge questionnaire and a 13-question validated patient activation measure. Genomic testing was assessed by chart review at 6-months follow-up. We used regression models to assess differences in mean knowledge and activation scores over time between groups and compared rates of genomic testing. Results: 75 Veterans were screened with 46 eligible. All 46 consented to participate, with 23 in each group. All were male (100%), had mean age of 76.3+/-5.54 years; 31 (67.4%) were Latinx; 2 (4.4%) Asian; 11 (23.9%) Black; 1 (2.2%) Native Hawaiian; 32 (69.6%) White; 32 (69.6%) had Stage 4 disease. At 1 month follow-up mean knowledge scores increased over time in the intervention group and remained stable in the control group (mean score 2.30 +/- 0.97 versus 1.16 +/- 1.15, p=0.014). At 1-month follow-up, patient activation increased for the intervention group more than the control group (46.7 +/- 11.3 versus 37.6 +/- 9.26, p=0.002). There were no significant differences in tumor testing between groups (intervention: 95.6% versus control: 86.9%, p=0.62) or time to first treatment course from biopsy (intervention: 28.2 days versus control 36.2 days). Conclusions: A volunteer led effort improved patient education regarding precision medicine and patient activation among Veterans as compared with usual care alone. Interventions that include volunteers and other support can enhance care and clinical outcomes among veterans with lung cancer. Clinical trial information: NCT05795959 .

Unraveling Sepsis Epidemiology in a Low- and Middle-Income Intensive Care Setting Reveals the Alarming Burden of Tropical Infections and Antimicrobial Resistance: A Prospective Observational Study (MARS-India).

Our study addresses the sepsis research gap in lower middle-income countries, notably India. Here, we investigate community-acquired sepsis comprehensively and explore the impact of tropical microbiology on aetiology and outcomes. MARS-India was a prospective observational study from Dec-2018 to Sep-2022 in a tertiary-care hospital in South India. Adult patients within 24hrs of ICU admission meeting the Sepsis 3.0 definition were enrolled, with 6-months follow-up (http://clinicaltrials.gov number NCT03727243). Over 4000 patients were screened on ICU admission, with 1000 unique patients meeting the inclusion criteria. Median age was 55 years (IQR: 44-65) with a male preponderance (66%). Almost half the cohort resided in villages (46.5%) and 74.6% worked in the primary sector. Mortality in-hospital was 24.1%. Overall, ∼54% had confirmed microbiological diagnosis. Over 18% had a viral cause of sepsis. Surprisingly, we identified leptospirosis (10.6%), scrub typhus (4.1%), dengue (3.7%) and Kyasanur forest disease (1.6%) as notables causes of sepsis. All these infections showed seasonal variation around the monsoon. In community-acquired infections we observed substantial resistance to 3rd generation cephalosporins and carbapenems. In India, sepsis disproportionally affects a younger and lower socio-economic demographic, yielding high mortality. Tropical and viral sepsis carry a significant burden. Analyzing local data, we pinpoint priorities for public health and resources, offering valuable insights for global sepsis research.