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Baseline participant characteristics from PATHFINDER 2, a prospective interventional study of a multi-cancer early detection test in a population setting
No full textA blood-based multi-cancer early detection (MCED) test has demonstrated feasibility as a screening tool in large-scale clinical trials. The PATHFINDER 2 (PF2) study (NCT05155605) evaluates safety and performance of the MCED test in a diverse intended-use population. To gauge generalizability of study results, we assessed participant (ppt) baseline characteristics vs general US population data from the National Health and Nutrition Examination Survey (NHANES). PF2, a prospective, multicenter, interventional study, enrolled ppts aged ≥ 50 y from diverse clinical settings in North America. Enrollment targets for sex and race/ethnicity were established from the 2019 American Community Survey (US Census Bureau). Recruitment strategies were implemented to maximize enrollment for groups historically underrepresented in clinical studies. Exclusion criteria included clinical suspicion of cancer or cancer diagnosis/treatment within 3 y. Data on baseline characteristics and key cancer risk factors were collected at enrollment. We compared the PF2 study population to a nationally representative sample of US adults aged ≥ 50 y from 2017-2020 NHANES data. NHANES data were weighted using complex, multistage probability sampling to generate a nationally representative sample. There were 35,878 ppts enrolled in PF2; 35,307 clinically eligible and evaluable ppts were included in this analysis. Mean age was 64 y for both PF2 and NHANES; 56.2% were females in PF2 vs 53.6% (95% CI 52.0-55.3%) in NHANES. Race/ethnicity distribution for PF2 vs NHANES was 7.4 vs 11.0% (8.9-13.1%) Hispanic, 74.6 vs 69.7% (65.0-74.5%) non-Hispanic (NH) White, 8.6 vs 10.3% (7.6-13.1%) NH Black, and 5.8 vs 5.1% (3.5-6.8%) NH Asian. In terms of lifestyle characteristics for PF2 vs NHANES, 58.9 vs 29.2% (25.8-32.7%) had at least a bachelor’s degree, 74.8 vs 63.8% (60.6-67.0%) were married/living with a partner, 69.3 vs 53.8% (50.9-56.7%) had never smoked, 66.5 vs 70.4% (68.0-72.8%) were overweight/obese, and 24.2 vs 28.4% (26.4-30.3%) reported never using alcohol. PF2 enrolled a diverse ppt population that is reasonably reflective of the demographics of the US population aged ≥ 50 y. As is typical for clinical trials, a higher percentage of PF2 vs NHANES ppts reported lifestyle characteristics associated with better health. As the study population largely reflects the MCED test intended-use population, safety and performance results from PF2 are expected to reflect real-world clinical experience
The ART of HAART: Rapid Recovery of HIV Associated Cardiomyopathy
No full textIntroduction: Acute systolic heart failure can have a myriad of etiologies. Evaluation of underlying pathophysiology is imperative for subsequent management. Infectious disease etiology remains an important factor, as it may often be reversible in nature. Case Report: A 28 year-old male with no past medical or high risk social history presented to an outside ED with difficulty breathing. He was treated for bronchitis 10 days prior. Due to increased work of breathing on presentation, he was intubated, with subsequent PEA arrest. TTE demonstrated EF 17% without LVH and catheterization revealed no coronary artery disease but low cardiac output and high filling pressures. An Impella CP device was placed for shock support. The course was complicated by altered mentation, hemolysis secondary to MCS, acute kidney injury requiring hemodialysis, congestive hepatopathy, and worsening respiratory status. He was then transferred for care escalation. Myocarditis workup revealed acute HIV infection with viral load 3,819,201 copies/mL and CD4 148 cells/mm3. Hypoxia continued to worsen secondary to PJP Pneumonia. After a multidisciplinary team discussion, the decision was made to escalate to Impella 5.5 as a bridge to recovery or LVAD candidacy; GDMT was started. He was deemed not a cardiac transplant candidate due to his high HIV viral load and immune incompetence. He was started on Bactrim with rapid improvement in respiratory status and his viral load dropped (444 copies/mL) within 3 weeks of HAART. A repeat echocardiogram showed an improvement in the LV function to 35%. Improvement in clinical status allowed Impella wean. He was eventually discharged with full renal recovery. At the last outpatient appointment, he was successfully walking 10,000 steps daily without restriction. Summary: Early recognition of acute decompensated heart failure and consideration of acute HIV illness is imperative. Early intervention can allow for recovery of cardiac function and improvement in functional status. [Formula presented
72263 | Outcomes of Patients Deemed Unsuitable for Transcatheter Tricuspid Valve Replacement
No full textBackground: Transcatheter Tricuspid Valve Replacement (TTVR) has shown promise for patients with severe Tricuspid Regurgitation (TR). Some patients may not be eligible due to anatomic limitations. We sought to describe the outcomes of patients referred for Transcatheter Tricuspid Valve Intervention (TTVI), who were deemed ineligible for TTVR. Methods: This was a single-center, retrospective study of eligible individuals referred for TTVI from February 2024 to February 2025. Patients were evaluated by a multi-disciplinary team that assessed eligibility for TTVI, with a primary goal of valve replacement if anatomically feasible. Data on demographics, clinical characteristics and outcomes were collected from medical records. Results: Out of 185 patients evaluated for TTVR, 24 (12.97%) were deemed unsuitable (Figure 1). Ten (41.67%) underwent T-TEER, and 14 (58.33%) received medical therapy. In the T-TEER group, 37.5% had a reduction in TR severity at one-month follow-up, though not statistically significant (p=0.11). KCCQ scores showed a trend toward improvement (p=0.10). No significant differences were found in rehospitalization (p=0.80) or mortality rates (p\u3e0.50) between groups. [Formula presented] Conclusion: In this initial commercial experience, rates of ineligibility for TTVR were lower than previously described. For those patients who did undergo T-TEER, rates of TR reduction and KCCQ improvement were similar to medical therapy. Additional percutaneous solutions are needed to address these patients
Decoding Right Ventricular Function: A Comprehensive Cardiac CT Analysis For Transcatheter Tricuspid Valve Replacement Success
No full textIntroduction: Severe tricuspid regurgitation (TR) leads to debilitating symptoms and higher mortality. Transcatheter tricuspid valve replacement (TTVR) improves symptoms and quality of life, but accurate assessment of right ventricular (RV) function is essential for patient selection. Echocardiography is commonly used but has limitations. Cardiac CT (CCT) offers high spatial resolution and could serve as a more reliable reference for evaluating RV function. This study evaluates pre-procedural RV function using 2D and volumetric CCT metrics in TTVR candidates. Methods: A retrospective analysis was performed on 42 patients who underwent TTVR using the EVOQUE tricuspid valve replacement system. All patients underwent pre-procedural imaging with CCT. Immediate pre-procedural TEE RV functional metrics were adjudicated by interventional echocardiographers with more than 10 years of experience. CT-based right ventricular function parameters, derived from volumetric and 2D CT data (FAC, tricuspid annular excursion, and RV longitudinal shortening), were compared to expert-adjudicated TEE standard parameters for RV function assessment. Correlation analyses were performed using adjusted R2 values. Results: CT RV volumetric ejection fraction showed a superior correlation with CT FAC (AdjR2 = 0.53) compared to CT RV free wall shortening (AdjR2 = 0.25), CT basal fractional shortening (AdjR2 = 0.38), and CT RV fractional shortening (AdjR2 = 0.02). It did not exhibit a strong correlation with TEE FAC either before or after the intervention (AdjR2 = 0.11 and -0.01, respectively).CT FAC demonstrated a strong correlation CT RV free wall shortening (AdjR2 = 0.42), and CT basal fractional shortening (AdjR2 = 0.56), while its correlation with CT RV fractional shortening was weaker (AdjR2 = 0.33). Similar to CT RV volumetric ejection fraction, CT FAC did not show a strong correlation with TEE FAC pre- or post-intervention (AdjR2 = 0.12 and -0.02, respectively). Conclusions: Pre-procedural CCT assessment of RV function is crucial for patients undergoing TTVR. Our findings reveal that echocardiographic RV metrics show poor correlation with CCT-based reference standards, highlighting the limitations of echocardiography. As pre-procedural CCT is routinely performed for TTVR, incorporating CT-based RV function metrics could provide more reliable and detailed information, potentially improving patient selection and predicting clinical outcomes more accurately. [Formula presented
TCT-21 Utility of Cerebral Embolic Protection in Transcaval Transcatheter Aortic Valve Replacement
No full textBackground: The utility of cerebral embolic protection (CEP) during alternative access TAVR is unclear. This study examines stroke rate in transcaval TAVR performed with and without CEP. Methods: This is a retrospective cohort study of 196 patients who underwent successful transcaval TAVR at Henry Ford Hospital from 2013-2025. Baseline characteristics and CEP use were obtained through review of electronic medical records. Peri-procedural stroke was confirmed with cerebral imaging. Results: Among 198 patients, 75 (37.9%) were male, with a mean age of 78.1 ± 9.3 years and an average STS mortality score of 7.39 ± 11.6. A history of prior stroke was present in 18 patients (9.09%). The overall post-TAVR stroke rate in the cohort was 2.02%. Stroke occurred in 1 of 59 patients (1.69%) who received CEP and 3 of 139 patients (2.16%) without CEP. CEP was associated with a nonsignificant reduction in stroke risk (RR 0.78; 95% CI, 0.08–7.49; p=1.00). The observed rate of periprocedural stroke in this cohort was not significantly different from contemporary standard access TAVR (RR 1.30; p=0.56). [Formula presented] Conclusion: CEP use was associated with a nonsignificant reduction in stroke risk, with event rates comparable to those reported in larger transfemoral studies and meta-analyses. The event rate did not differ significantly from contemporary rates for standard access TAVR. While limited by sample size and event frequency, this study represents, to our knowledge, the largest single-center description of stroke rate following transcaval TAVR. Larger studies are needed to better define the role of CEP in alternative access TAVR. Categories: ENDOVASCULAR: Stroke, Stroke Prevention, Carotid Interventio
TCT-815 Rates of Paravalvular Leaks Requiring Percutaneous Repair With Plugs After Valve-in-Ring Transcatheter Mitral Valve Replacement, Large Single Center Experience
No full textBackground: Transcatheter mitral valve-in-ring (tViR) has been shown to be an effective alternative to re-do surgery for failed annuloplasty repairs. Mitral paravalvular leak (mPVL) is a sequela of mitral repair annuloplasty operations. The incidence of pre-existing concomitant versus new or worse mPVL after tViR is not well known. Methods: This was a single-center retrospective analysis of 58 patients who underwent tViR, between 2017 and 2025, for severe symptomatic MR due to failure of a pre-existing surgical ring. Pre- peri- and post-procedural TEEs were assessed for the presence of pre-existing or worsening mPVL after tViR, as well as management and outcome findings. Results: 12/58 (20%) patients undergoing mitral tViR had moderate or worse mPVL requiring PVL repair after valve deployment. 7 of the 12 (58%) had pre-existing mPVL on baseline TEE, with 2 of 7 having mild PVL that became severe, and 5 of 7 patients having moderate or worse PVL at baseline. 5 of the 12 (42%) patients had no PVL on baseline TEE assessment, with development of new moderate or worse PVL after tViR. All 12 patients underwent successful percutaneous PVL repair with Amplatzer plugs yielding final mild MR or less; 10 had the PVL repair at time of tViR and 2 had it in a staged intervention. Of note, 13/58 (22%) had skirt leak necessitating a second valve. There was no association between PVL repair and 1-yr mortality in this relatively small cohort. Conclusion: In this single center study, we found a higher than previously reported incidence of mPVL requiring percutaneous repair with plugs after mitral tViR (20%). 12% (7/58) of the cohort had pre-existing PVL that worsened or was baseline severe. 8.6% (5/58) of the cohort had new PVL after tViR. Close attention should be paid during mitral tViR procedures for the possibility of baseline mPVL and new or worsening mPVL, and these procedures should ideally be performed by teams capable of performing mPVL repair procedures. Categories: STRUCTURAL: Valvular Disease and Intervention: Mitra
TUScholarShare Update: Celebrating 5 Years of Search Data Deposits
No full textTemple University Libraries are celebrating the 5th anniversary of our institutional repository, TUScholarShare in 2025. In this presentation, we will give an overview of the first 5 years of the repository and provide an update from our first MIRL presentation in 2021 on the use of an institutional repository to share strategies for evidence synthesis projects. Evidence synthesis projects are an important research method based on transparency and depositing strategies reinforces that ethos. Librarians and information specialists working on these projects often look for existing searches as part of their workflow, and we have expanded the service over the years to include the PRISMA numbers, search strategies, and raw data files used for screening. At the time of our first presentation ours was a novel service, and as the service has grown, we have also expanded our collaboration with units across the libraries at Temple. The presentation will include statistics on deposits, downloads, related publications, and the distribution of departments the service has worked with over the past five years
Efficacy and safety of seladelpar in patients previously treated with fibrates or OCA
No full textBackground and aims: Seladelpar is a first-in-class delpar (selective PPAR-delta agonist) indicated for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in patients (pts) with an inadequate response to UDCA or as monotherapy in pts unable to tolerate UDCA. RESPONSE was a Phase 3, randomised, placebo-controlled clinical trial of seladelpar in pts with inadequate response intolerance to UDCA. Pts completing RESPONSE were eligible to roll over into ASSURE (NCT03301506), an ongoing, open-label, long-term, Phase 3 safety trial. Here we describe data from month 18 (month 6 of ASSURE) in pts with or without prior use of fibrates or obeticholic acid (OCA) who rolled over from RESPONSE into ASSURE. Method: Pts received 10 mg seladelpar orally daily or placebo in RESPONSE; pts received open-label 10 mg seladelpar in ASSURE. Fibrates and OCA were prohibited during the study period and a 6- week washout was required prior to entry in RESPONSE. Data are described for pts in ASSURE with or without prior use of fibrates OCA and based on whether they received seladelpar (continuous seladel par pts) or placebo (crossover pts) in RESPONSE. Efficacy included the percentage of pts achieving a composite biochemical response (CBR; alkaline phosphatase [ALP] \u3c1.67 × upper limit of normal [ULN], ALP decrease ≥15%, and total bilirubin ≤ULN). Safety assessments included adverse events (AEs) and laboratory parameters. Results: Among pts who continued into ASSURE from RESPONSE (158), 16 continuous seladelpar and 11 crossover pts reported prior use of fibrates OCA (total, n = 27; 17%); 88 continuous seladelpar and 43 crossover pts reported no prior use of fibrates OCA (total, n = 131; 83%). At month 18, among continuous seladelpar pts, 9 15 (60%) pts with prior fibrate OCA use achieved a CBR vs 54 87 (62%) pts without prior fibrate OCA use. Among crossover pts, 7 11 (64%) pts with prior fibrate OCA use vs 32 41 (78%) pts without prior fibrate OCA use achieved a CBR at month 6 of ASSURE. From ASSURE initiation to month 6, incidence of AEs was similar across continuous seladelpar and crossover pts, regardless of prior OCA fibrate use; no treatment-related serious AEs were reported. Conclusion: In this interim analysis of continuous seladelpar and crossover pts from ASSURE, pts who reported prior use of fibrates OCA achieved a similar sustained biochemical response with seladelpar compared with pts who reported no prior use. Seladelpar appeared safe and well tolerated in this subgroup
Colorectal cancer mortality dynamics: Uncovering critical disparities in U.S. population health (2018-2023)
No full textBackground: Colorectal cancer(CRC) remains the third leading cause of cancer-related deaths in the United States, with a disproportionate burden on underserved populations. Despite established screening protocols and preventive measures, fewer than 35% of cases are detected early, significantly impacting survival rates. This study examines mortality patterns across demographic and geographic divides, revealing urgent public health priorities. Methods: This retrospective analysis was performed in adults aged 25 and older using the CDC WONDER database (2018-2023) using ICD-10 codes. We stratified mortality data by age, gender, race, geographic region and urbanization level to identify critical disparities and emerging trends. Crude mortality rates (CMRs) and Age-adjusted mortality rates (AAMRs) per 100,000 were calculated by age, gender, region and race, with 95% confidence intervals (CI) for precision. Temporal trends and annual percentage changes (APCs) were analyzed using Joinpoint regression. Results: From 2018 to 2023, among 313,744 deaths, mortality increased from 51,891 to 53,497, while theAAMR for CRC consistently declined from 12.92 to 12.44. The highestCMRwas in the 85+ group (156.11 per 100,000,95% CI: 153.05-159.17), followed by 75-84 (74.18,95%CI: 72.87-75.49), 65-74 (40.27, 95% CI: 39.58-40.96), and 55-64 (23.83, 95% CI: 23.37-24.30). The 45-54 group had a CMR of 11.74 (95% CI: 11.40-12.07), the 35-44 group 3.56 (95% CI: 3.38-3.74), the 25-34 group 0.77 (95% CI: 0.69-0.86), and the 15-24 group had the lowest at 0.09 (95% CI: 0.06-0.12). Males had a higher CMR of 17.23 per 100,000 (AAMR: 15.19, APC: -0.68, p = 0.21) than females, who had 14.42 per 100,000 (AAMR: 10.69, APC: -0.30, p = 0.56). The Midwest had the highest AAMR at 13.33 per 100,000 [APC: -0.78 (95% CI: -2.54 to 1.01, p = 0.31)], followed by the South at 13.54 [APC: 0.05 (95% CI: -0.80 to 0.92, p = 0.91)], the West at 11.90 [APC: 0.09 (95% CI: -0.79 to 0.95, p = 0.82)], and the Northeast at 11.54, with a significant decline in trends [APC: -1.90 (95% CI: -3.24 to -0.58, p \u3c 0.01)]. Large central metro areas accounted for 25.3% of deaths (83,341), followed by large fringe metro areas (22.4%), medium metros (19.9%), micropolitan areas (10.0%), small metros (9.4%), and noncore areas (8.2%). Racial disparities showed White individuals with the highest CMR at 17.01 per 100,000 (AAMR: 12.69, APC: -0.78), while Black or African American individuals had a slightly lower CMR at 15.70 per 100,000 but the highest AAMR at 16.18 (APC: -1.63, p \u3c 0.01), followed by American Indian or Alaska Native, Asian, Native Hawaiian, and other groups. Conclusions: These findings reveal critical gaps in CRC prevention and care, disproportionately affecting young adults, males, and minorities. Public health initiatives must expand screening, improve access to care, and address regional inequities to reduce mortality and promote health equity
Impact of Glucagon Like Peptide-1 (GLP-1) Analogue Medications on Liver Transplant Risk Factors
No full textPurpose: Patients who undergo liver transplantation are at higher risk of complications from diabetes and obesity. Recently, GLP-1 analogues have revolutionized management of these conditions and are increasingly being used in post-transplant patients. However, the safety of these agents in this population, particularly their association with cancer risk, is controversial. We aimed to assess the association of semaglutide and tirzepatide with cancer in patients who undergo liver transplant. Methods: All patients who underwent liver transplant at our institution were included from 1 2018-12 2023. We did a retrospective cohort study to assess whether they received GLP-1 analogues, including semaglutide and tirzepatide, after the liver transplant. Primary outcome was development of malignancy. Secondary outcomes were 1-and 3-year mortality. Results: 366 patients were included who underwent liver transplant from 01 2018-12 2023. Of these, 42(13%) were exposed to semaglutide or tirzepatide while 324(88%) had no such exposure. The mean age of the population was 58.12 + - 7.6 in the exposed group and 58.44 + - 11.5 in the control group. Comorbidities, including HTN, stroke and ESRD were comparable in both groups. 37(88.1%) in the exposed group had diabetes while 111(34.2%) in the control group had diabetes(p\u3c0.001). Similarly, 28(66.7%) patients in the exposed group had BMI\u3e30 while 111(34.5%) patients in the control group had BMI\u3e30(p\u3c0.001). The follow up period was 3.74 + -1.3 years for the exposed group and 4.01 + -1.5 years in the control group. For outcomes, 2(4.8%) patients in the exposed group were diagnosed with cancer in the follow up period versus 26(8.1%) in the control group (p=0.76). There was no cancer related mortality at one year while at 3 years, it was similar in both groups. For malignancies, 1(50%) patient in the exposed group had HCC, while 5(18%) patients in the control group had either HCC or cholangiocarcinoma. No patients in the exposed group were diagnosed with skin related malignancies including BCC, SCC and Malignant Melanoma, while 13(46%) patients in the control group were diagnosed with such malignancies. 1 patient in the exposed group was diagnosed with Post Transplant Lymphoproliferative Disorder. 11 patients in the control group were diagnosed with other malignancies including prostate cancer, lymphoma, follicular thyroid cancer, and leukemia. Conclusions: In our cohort, the use of GLP-1 analogues was not associated with cancer in patients who undergo liver transplantation. We were limited by single center and smaller number of patients. Further large scale, multicenter studies are needed to confirm the safety of these medications. [Formula presented] CITATION INFORMATION: Faisal M., Saleem A., Fatima M., Chaudhary A., Shahzil M., Faisal M., Jafri S. Impact of Glucagon Like Peptide-1 (GLP-1) Analogue Medications on Liver Transplant Risk Factors AJT, Volume 25, Issue 8 Supplement 1 DISCLOSURES: M. Faisal: None