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Middle Meningeal Artery Embolization: Poised to Become the Standard of Care For Chronic Subdural Hematoma
Recruitment, retention and recouperation: lessons learned from a study aimed at assessing burnout mitigation in physician learners
OBJECTIVE: This study aimed to assess the effectiveness of acceptance and commitment therapy (ACT) compared to virtual body mapping (VBM) on reducing burnout symptoms. The recruitment and data collection for this study took place between May 2023 – May 2024. PLs were randomized into either ACT or VBM. Baseline and post-intervention measures included the Maslach Burnout Inventory (MBI), the Perceived Stress Scale (PSS-10), the State-Trait Anxiety Inventory (STAI tx-1), Centers of Epidemiologic Studies Depression Scale (CES-D), the Brief Resilient Coping Scale (BRCS), and the Acceptance and Action Questionnaire (AAQ-II). Descriptive statistics were calculated.
RESULTS: Of 58 enrolled participants, 13 completed the study (23% completion). Descriptive results suggest that PLs in ACT saw improvement in the average scores for STAI tx-1, CES-D, and AAQ-II. PLs in VBM saw improvement in the average score for the MBI, PSS-10, STAI, CES-D, BRCS, and AAQ-II. Barriers to recruitment and retention affected the study’s success, resulting in modifications to the recruitment strategy, study protocol, and data analysis. Insights from this study offer researchers an opportunity to improve the design of future work involving PLs. Studies involving PLs should consider integrating participation into clinical schedules and ensuring funding to support recruitment and retention
Organ Care System Heart Perfusion (OHP) Registry Annual Report 2024 - Donation After Circulatory Death (DCD) Donors
Purpose: DCD donation has significantly expanded the donor pool resulting in increased number of heart transplantations. In this study, we examine the outcomes of transplantation from donation after circulatory death (DCD) that used OCS comparing it with non-OCS DCD heart transplantations. Methods: DCD cohort from the OCS heart perfusion (OHP) registry constituted the OCS cohort. Organ Procurement and Transplantation Network (OPTN) database was used to identify DCD transplants from same centers during the same time period that were not supported on OCS, which constituted the non-OCS cohort. Donor and recipient characteristics and survival data was available from the OPTN database for both arms and these data were compared. OCS cohort was further analyzed by cases managed by the National OCS program (NOP) versus direct acquisition by the transplant center. Results: A total of 889 OCS DCD and 354 non-OCS DCD transplants were identified. The recipients in the OCS cohort were more likely to be on ventricular assist device at transplant (38.8% vs 28.2%), had longer distance between donor and recipient (449miles vs 304miles) and be in UNOS status 2 (45.8% vs 31.1%) and less likely to be in status 4 (20.4% vs 32.88%). The cross-clamp time duration on average was higher (379 min vs 226 min) and the ischemic time was shorter (112.7 min vs 226.8 min). Despite the recipient risk differences, 6-month and 1-year survival was similar in both cohorts (92.8% vs 92.5% and 90.4 vs 88.9%; p=0.844) Conclusion: OCS allows DCD hearts to be procured over longer distances, with longer cross-clamp times and also enables utilization for higher risk recipients, without compromise in 1 year post-transplant outcomes. OCS may, therefore, allow increased access to DCD transplantation, particular for the higher risk recipient and where the donor hospital is distant
TCT-662 Percutaneous Mechanical Aspiration for Right-Sided Infective Endocarditis in People Who Inject Drugs and Those with Cardiovascular Implantable Electronic Devices: Insights From the CLEAR-IE Multicenter Registry
Background: Percutaneous mechanical aspiration (PMA) has emerged as a therapeutic option for right-sided infective endocarditis (RSIE). Existing data originate from diverse populations, and comparative characteristics and outcomes between people who inject drugs (PWID) and patients with cardiac implantable electronic devices (CIED) are unclear. Methods: This was an analysis from CLEAR-IE (Cardiac Lesion Extraction and Aspiration Registry for Infective Endocarditis), a registry of adults with RSIE who underwent PMA at 19 US centers between 01/2014 and 01/2024. Patients were stratified into either the PWID or CIED group. The primary outcome was procedural success, defined as ≥70% reduction in vegetation size or residual vegetation \u3c10 mm. Secondary outcomes included a composite of in-hospital death, new pulmonary embolism (PE), or emergency surgery. Data were summarized using descriptive statistics with complete case analysis. Results: Of 182 patients, 122 (67.0%) were PWID and 60 (33.0%) had CIED. PWID were significantly younger (36 vs 65 years; P\u3c0.001), had fewer comorbidities, and more frequently had prior infective endocarditis (28.7% vs 5.8%; P\u3c0.001). PWID exhibited higher rates of septic PE (80.3% vs 11.7%; P\u3c0.001), hypoxia at presentation (41.0% vs 25.0%; P=0.034), and persistent sepsis despite antibiotics (77.9% vs 41.7%; P\u3c0.001). Staphylococcus species were more common in PWID (88.3% vs 49.2%; P\u3c0.001). Vegetation sizes were similar (26.5 vs 23.0 mm; P=0.35). Continuous-flow aspiration was more frequently used in PWID (93.9% vs 63.8%; P\u3c0.001). Procedural success was achieved in 84.3% and 96.5% of patients in the PWID and CIED groups, respectively. Secondary outcome rate was 18.0% and 23.3% in the PWID and CIED groups, respectively. Self-directed discharge occurred primarily among PWID (15.8% vs 0.0%; P=0.003). Of those with follow-up at 6-weeks (N=151), overall mortality was 9.3% (9/97) and 18.5% (10/54) in the PWID and CIED groups, respectively. Conclusion: PWID and CIED subgroups with RSIE demonstrate distinct clinical profiles and outcomes following PMA. These findings underscore the importance of subgroup-specific evaluation and tailored risk stratification in future prospective studies. Categories: STRUCTURAL: Valvular Disease and Intervention: Tricuspi
TCT-993 Comparison of Outcomes in Patients With and Without Chronic Kidney Disease Undergoing Transcatheter Tricuspid Valve Replacement (TTVR)
Background: Patients with chronic kidney disease (CKD), including those on end-stage renal disease (ESRD), undergoing transcatheter tricuspid valve replacement (TTVR) may be at increased risk of adverse outcomes. This study aims to compare clinical outcomes following TTVR in patients with versus without CKD/ESRD. Methods: We analyzed 112 patients who underwent TTVR for TR. Patients were stratified into two cohorts: CKD/ESRD (n=18) and no CKD/ESRD (n=94). Baseline characteristics and clinical outcomes were compared, including functional status, residual TR, and major adverse events. Results: Patients with CKD/ESRD were younger (74.5 ± 6.5 vs. 78.8 ± 9.8 years) and had a higher mean BMI (30.2± 5.3 vs. 27.7 ± 5.9). Baseline NYHA class III/IV and TR severity were similar across groups. At 30 days follow-up, all-cause mortality was slightly higher in the CKD/ESRD group (5.6% vs. 2.1%). Residual TR reduction was achieved in 100% of CKD/ESRD and 97% of no-CKD/ESRD patients. CKD/ESRD patients had a higher rate of bleeding (38.9% vs. 27.7% p=0.39) and new pacemaker implantation (22.2% vs. 8.5% p=0.08). Functional outcomes were comparable overall, although a greater proportion of CKD/ESRD patients remained in NYHA class III/IV at follow-up (28.6% vs. 20.0%). KCCQ-OS scores were similar between groups (59.8 ± 20.7 vs. 63.3 ± 24.2). [Formula presented] Conclusion: TTVR in patients with CKD/ESRD appears to provide comparable functional improvement as in those without CKD. However, the CKD/ESRD group showed a trend toward higher bleeding rates and pacemaker implantation, underscoring the need for individualized risk assessment and clinical management. Categories: STRUCTURAL: Valvular Disease and Intervention: Tricuspi
TCT-224 Transcatheter Tricuspid Valve Replacement with Evoque after Tricuspid Transcatheter Edge-to-Edge Repair
Background: For patients with severe tricuspid regurgitation (TR) who are not candidates for surgery, tricuspid transcatheter edge-to-edge repair (TTEER) improves QOL. However, not all patients have optimal results of TTEER. Transcatheter tricuspid valve replacement (TTVR) has been reported after TTEER, but short term procedural results are not known, and some TEER devices may interfere with TTVR expansion and require electrosurgical treatment. Methods: We report a case series of TTVR after TTEER, including a large subset who underwent electrosurgical leaflet modification using the CLEFT (Clip LibEration to Facilitate TTVR) technique. Results: Sixteen (16) patients with severe TR after TTEER were treated in 4 centers with TTVR using the Evoque valve (Edwards). Age was 75.3 years, and 68.8% were female. STS PROM was 9.3%. Class III/IV NYHA class was 81.3%, and all patients had severe, massive or torrential TR (Figure 1). Mean number of TEER devices was 1.8. Eight patients underwent successful leaflet laceration with CLEFT prior to TTVR. The Evoque frame conformed to the TEER devices visibly (Figure 1). TR severity was excellent at 30 days (Figure 1) and only 13.3% had TR greater than mild. NYHA class I/II at 30 days was 86.7%. [Formula presented] Conclusion: We present the largest series to date (16 cases) of successful TTVR after TTEER. Electrosurgical leaflet modification was performed in a large subset of patients, successfully optimizing leaflet function and TEER mobility prior to TTVR. At 30 days, tricuspid regurgitation severity at 30 days was excellent, with no cases of severe paravalvular leak, and NYHA Class was improved. Categories: STRUCTURAL: Valvular Disease and Intervention: Tricuspi
Physician perspectives on hepatitis C treatment for women of childbearing age and during pregnancy: results from a global multispecialty survey
Background and aims: There is limited guidance regarding hepatitis C virus (HCV) treatment in pregnancy but emerging data suggests direct acting antiviral (DAA) therapy for these patients is safe and effective. We performed a global survey among gastro-hepatologists (GI-hep), infectious disease (ID) specialists, obstetricians (ob-gyn), and primary care physicians (PCPs) to explore current perspectives on HCV treatment in pregnancy. Method: A 39-item survey was designed by members of The Global Liver Council (GLC) through an iterative process including revisions by experts at GLC, American College of Obstetricians and Gynecologists (ACOG), and the Coalition for Global Hepatitis Elimination (CGHE). The survey was distributed electronically starting in 9 2024 through GLC, CGHE, ACOG and institutional provider networks. Multivariable regression was performed to evaluate predictors of willingness to treat HCV in pregnancy. Results: To date, 442 surveys have been completed from 49 countries (53% GI-hep, 29% PCPs, 18% Ob-Gyns, 10% ID). 30% of respondents reported that ≥ 50% of their patients were women of childbearing age. Regarding HCV knowledge, 66% of providers self-assessed as adequate or superior (89% GI-hep, 49% PCPs, 26% Ob-Gyn, p \u3c 0.01), and 63% reported being comfortable treating HCV (88% GI-hep, 42% PCP, 21% Ob-Gyn, p \u3c 0.01). Majority (80%) reported discussing pregnancy plans with HCV-positive women; 77% screen for pregnancy prior to initiation of DAAs. Only 12% reported treating a pregnant woman with DAAs (8% GI-hep, 13% PCP, 22% Ob-gyn, p \u3c 0.01), and 21% would consider treating these patients (14% GI-hep, 24% PCP, 37% Ob-Gyn, p \u3c 0.01). The main reasons for not considering DAAs in pregnancy were lack of safety data for DAAs in pregnancy (60% of responders) and adequate guidelines (56%). Majority of Ob Gyns (57%) would refer to specialty care for HCV treatment during pregnancy. If an individual became pregnant while on DAAs, 29% would continue, 31% would stop, 23% would refer to another specialist, and 13% did not know. Across regions of the world, the highest acceptance of DAA use in pregnancy was in North America (45% vs. \u3c 0.01). In multivariate analysis, the only predictor of a greater willingness to treat HCV in pregnancy was having ≥ 10% of practice that are injection drug use population (adjusted OR (95% CI) = 2.5 (1.5–4.2)) while GI-hep specialty was associated with a lower willingness (OR = 0.4 (0.2–0.7)). Conclusion: Despite adequate levels of HCV knowledge, few providers have experience with HCV treatment in pregnancy or would consider it. Ob-gyns are more in support of HCV treatment in pregnancy, but less comfortable treating themselves, which can lead to referral to specialists who are reluctant to treat. Further availability of safety evidence and inclusion of specific recommendations in guidelines could increase uptake of DAAs for pregnant individuals
Glucagon-Like Peptide-2 Therapy Outcomes Following Intestinal and Multivisceral Transplantation: A Multicenter Experience
Purpose: Glucagon-like peptide-2 (GLP-2) plays a critical role in intestinal adaptation, mucosal growth, and nutrient absorption. While GLP-2 therapy has shown benefits in patients with short bowel syndrome, its effects following intestinal transplantation (IT) and multivisceral transplantation (MVT) remain unknown. This study aims to describe the clinical outcomes of patients who received GLP-2 therapy after IT or MVT, providing insights into its potential role in post-transplant recovery and long-term outcomes. Methods: A retrospective analysis was conducted on sev7en patients who received GLP-2 therapy following IT or MVT across four transplant centers between 2014 and 2024. Results: Among the 7 transplant recipients, there were 2 men and 5 women. 5 patients underwent IT alone, while 2 underwent MVT. The median age at transplantation was 46 years (mean 45, range 19-62), with a median transplant waitlist time of 71±109 days. 71% of recipients developed short bowel syndrome due to bowel resection, while 29% had dysmotility as the underlying cause. All patients received teduglutide, with 57% starting treatment prior to undergoing IT. At GLP-2 initiation, 71% of patients were dependent on total parenteral nutrition (TPN), and with treatment, 67% successfully transitioned off TPN. GLP-2 therapy was eventually discontinued in 71% of patients, with bowel obstruction being the most common reason (67%). Notably, all patients retained their colons post-transplant. No patients had a history of colon polyps or colon cancer, and no polyps were detected during follow-up colonoscopies. Only one patient died 66 days post-transplant due to septic shock from a leg abscess, which occurred 10 days after discontinuing GLP-2 treatment. The remaining patients surpassed the 1- and 3-year survival milestones and did not have any infectious complications on treatment. Conclusions: GLP-2 therapy may play a beneficial role in intestinal adaptation and post-transplant recovery, potentially facilitating independence from TPN in IT and MVT recipients. Bowel obstruction appears to be the main complication leading to therapy discontinuation and occurred in the majority of patients undergoing GLP-2 therapy. Despite these challenges, survival outcomes were generally favorable, warranting further investigation into the long-term benefits and risks of GLP-2 therapy in transplant recipients. CITATION INFORMATION: Toiv A., Justus H., Lee V., Altamura-Murgia G., Horslen S., Weiner J., Schiano T., Segovia M., Jafri S. Glucagon-Like Peptide-2 Therapy Outcomes Following Intestinal and Multivisceral Transplantation: A Multicenter Experience AJT, Volume 25, Issue 8 Supplement 1 DISCLOSURES: A. Toiv: None
FRI-030 In patients with metabolic dysfunction-associated steatotic liver disease, sleep disturbance is highly prevalent and associated with a profound impairment of health-related quality of life
Background and aims: Metabolic dysfunctional-associated steatotic liver disease (MASLD) patients have impaired health-related quality of life and other patient-reported outcomes (PROs) which can be exacerbated by comorbidities, including sleep disorders. Our aim was to assess the prevalence of sleep disturbance and its association with PROs in MASLD. Method: Patients with MASLD were prospectively enrolled into the Global NAFLD MASLD Registry™ (GNR). Clinical and PROs (FACIT-F, CLDQ-MASH, and WPAI) data were analyzed by the presence of sleep disturbance (defined as CLDQ-MASH Sleep score of \u3c4on a 1-7 scale). Results: 5342 MASLD patients from 17 countries in the GNR were included: mean (SD) age 53 (13) years, 48% male and 60% obese, 41% had type 2 diabetes (T2D), 46% hypertension, 43% hyperlipidemia, 15% with advanced fibrosis (by biopsy or FIB-4 or transient elastography), 20% depression, 52% clinically overt fatigue, 32% abdominal pain, and 20% sleep apnea. Prevalence of sleep disturb¬ance among MASLD was 34%. MASLD patients and sleep disturbance were more commonly female (63% vs. 46%), with more components of metabolic syndrome (obesity 65% vs. 57%, T2D 47% vs. 37%, hypertension 54% vs. 42%, hyperlipidemia 51% vs. 39%), non-hepatic comorbidities (anxiety 52% vs. 24%, depression 31% vs. 13%, clinically overt fatigue 60% vs. 48%) and sleep apnea (26% vs. 16%) than those without sleep disturbance (all p \u3c 0.01). In logistic regression model, presence of sleep disturbance in MASLD was associated with older age, female sex, history of anxiety, depression, clinically overt fatigue, abdominal pain, smoking, lack of regular exercise, and presence of significant pruritus (all p\u3c0.01). In MASLD patients with sleep disturbance, PRO scores in all domains of CLdQ-MASH and FACIT-F were lower (up to -25% of a score range size), and work productivity impairment was higher (mean [SD] 0.30 [0.33] vs. 0.11 [0.23]) (all p \u3c 0.0001). In particular, the presence of sleep disturbance was strongly associated with lower fatigue scores of CLDQ-MASH and FACIT-F (more fatigue) and with lower pruritus scores (more pruritus) of CLDQ-MASH (effect size -17% to -23%, all p\u3c 0.0001). In multiple regression analysis, sleep disturbance was independently associated with lower PRO scores in all domains of CLDQ-MASH, FACIT-F, and WPAI (beta up to -15%). Other independent predictors of lower PRO scores in MASLD included age, female sex, comorbidities (metabolic syndrome components, psychiatric disorders, clinically overt fatigue, and sleep apnea), advanced fibrosis, smoking, and lack of regular exercise ( p \u3c 0.05). Conclusion: Sleep disturbance is highly prevalent in patients with MASLD. It is associated with fatigue and pruritus, non-hepatic comorbidities, lifestyle factors, and substantial impairment in HRQL and work productivity. Patients with MASLD should be assessed for sleep disturbances and advised accordingly
SAFETY OF SELADELPAR IN PATIENTS WITH PRIMARY BILIARY CHOLANGITIS WITH CIRRHOSIS AND CLINICAL SIGNS OF PORTAL HYPERTENSION: DATA FROM THE ENHANCE AND RESPONSE STUDIES
Seladelpar is a first-in-class delpar (selective PPAR-delta agonist) indicated in the UK for the treatment of primary biliary cholangitis (PBC) including pruritus in combination with ursodeoxycholic acid (UDCA). In two Phase 3, placebo-controlled studies (ENHANCE [NCT03602560], RESPONSE [NCT04620733]), seladelpar significantly reduced cholestatic markers and pruritus with a safety profile similar to placebo. Here, we present pooled safety data from these studies in a subgroup of patients with cirrhosis and portal hypertension (PHT). Patients with PBC who received UDCA for \u3e12 months or were UDCA intolerant, with alkaline phosphatase (ALP) \u3e1.67 × upper limit of normal (ULN) and total bilirubin (TB) \u3c2 × ULN, were randomised 1:1:1 to daily, oral placebo, seladelpar 5 mg, or seladelpar 10 mg for up to 52 weeks in ENHANCE and 2:1 to seladelpar 10 mg or placebo for 52 weeks in RESPONSE. Cirrhosis was defined by medical history, liver biopsy, transient elastography, laboratory findings, radiological features, or clinical determination by the investigator. Patients with cirrhosis were identified as having signs of PHT at baseline if they had thrombocytopenia (platelet count \u3c140 × 103 mL), low albumin, elevated TB, or history of varices or ascites. Among 56 patients with cirrhosis at baseline across the two studies, 27 had signs of PHT at baseline (21 on seladelpar [15 21 on 10 mg], 6 on placebo). Most patients were female (85%) and White (89%), with a mean (range) age of 55.6 (33-74) years, and baseline mean ALP and TB levels of 319.9 U L and 1.2 mg dL. Mean (SD) liver stiffness was 17.4 (3.5) kPa with placebo and 21.0 (11.8) kPa with seladelpar. In total, 5 6 (83%) patients on placebo and 15 21 (71%) patients on seladelpar experienced an adverse event (AE); 2 6 (33%) patients on placebo and 1 21 (5%) patients on seladelpar discontinued treatment due to AEs. Serious AEs occurred in 1 6 (17%) patients on placebo and 1 21 (5%) patients on seladelpar and were deemed unrelated to study drug. Liver-related AEs by a predefined search strategy were similar across patients on placebo (2 6, 33%) or seladelpar (3 21, 14%) and included hepatomegaly, ascites, hyperbilirubinaemia, and portal hypertensive gastropathy. Liver-related laboratory abnormalities by predefined categories occurred in 2 6 (33%) placebo-treated patients and 1 21 (5%) seladelpar-treated patients. In this pooled analysis of patients with PBC and cirrhosis with clinical signs of PHT from the ENHANCE and RESPONSE studies, safety outcomes were overall similar between seladelpar and placebo, with no new safety signals