Short Follow-up Research Articles

Plasma transurethral enucleation of prostate adenoma measuring 640 cm<sup>3</sup>

A case report of successful plasma transurethral enucleation of a giant prostate adenoma (640 cm3) is presented. The short term postoperative follow-up showed the absence of functional and organic complications. The comparison was made with the results of surgical treatment of giant prostate adenoma by classical transurethral prostate enucleation methods obtained at “RZD Meditsina” Nizhny Novgorod Urological Clinic in 2015, it revealed a decrease in the intraoperative period by 55 minutes without an increase in intraoperative blood loss and surgical complications. The results obtained demonstrate the prospects for the widespread introduction of plasma methods of transurethral surgery into urological practice.

BS O03 - One-stage conversion of Adjustable Gastric band (AGB) to One-anastomosis Gastric Bypass (cOAGB) versus Sleeve Gastrectomy (cSG): A single-center experience with a short and mid-term Follow-up

Abstract Background Laparoscopic adjustable gastric band was a common bariatric procedure . However; due to its failure rate some patients sought another revisional surgery. In which, we compared two of the most common Bariatric metabolic surgery (BMS) performed nowadays: the laparoscopic sleeve gastrectomy and laparoscopic one- anastomosis gastric bypass. Method A prospective cohort study was conducted from June 2020 to June 2022 at a single medical center, which included 77 patients undergoing single-stage conversion to (cOAGB) vs (cSG). Patients were reassessed for weight loss, associated medical problems remission and post-operative complications at 6, 12, and 18 months. Results Group (I) was 43 patients who underwent cOAGB and Group (II) was 34 patients who underwent cSG. The BMI was calculated post-operative at three visits. Both groups had no statistically significant values at 6 and 12 months follow-up. However, patients who underwent cOAGB after 18 months of follow-up achieved lower BMI than those who underwent cSG . Regarding EBWL% there was a statistically significant difference between the two groups after 6, 12 and 18 months follow-up. Regarding associated medical problems remission with follow-up 18 months post-operative , there were no statistically significant differences between the two groups Conclusion This study suggests that the conversion of LAGB to either cOAGB or cSG could be feasibly performed in a single-stage operation. cOAGB had a significant difference as regards the weight loss results than cSG among the mid-term follow-up. However, there is no significant difference in the postoperative complications and the resolution of the co-morbidities. Therefore, cOAGB could provide a reliable alternative but needs to be substantiated in future long-term studies.

Anatomic Total Shoulder Arthroplasty Revised to Reverse Total Shoulder Arthroplasty: Clinical and Radiographic Outcomes Compared to Primary Reverse Total Shoulder Arthroplasty

Reverse total shoulder arthroplasty (rTSA) has become the procedure of choice for a failed aTSA. Little data exists regarding outcomes; the few studies published to date have small numbers, short follow-up, and most do not have a control group or use first generation implants. The purpose of this study is to compare the clinical and radiographic outcomes of failed aTSA revised to rTSA to primary rTSA. A prospective multicenter shoulder registry was used to conduct a retrospective review of patients that received a primary rTSA for osteoarthritis and rotator cuff disease and compare them to those that had an aTSA revised to a rTSA using the same implant between 2007 and 2021 with a minimum follow-up of two years. Cohorts were matched 3:1 (primary:revision) by age, gender, body mass index and length of follow-up. Those that underwent revision for humeral fracture, infection, or an unknown reason were excluded. Preoperative and postoperative range of motion (ROM) and patient reported outcome measures (PROMs) were compared. Outcomes included rates of scapular notching, complications, revision, and patient satisfaction. There were 88 aTSA revised to rTSA compared to 264 matched primary rTSA. In both cohorts, the mean age was 68 years, 59% were female, and the mean follow-up was 56 months. The most common reason for revision was rotator cuff tearing (53%), followed by aseptic glenoid loosening (34%), instability (9%), aseptic humeral loosening (6%) and glenoid component dissociation (3%). At latest follow-up, patients in both groups had statistically significant improvements in all outcome scores, exceeding the minimal clinically important difference (MCID) and the substantial clinical benefit (SCB). The revision cohort had significantly less postoperative abduction (P<0.001) and forward elevation (P=0.001) compared to the primary rTSA cohort. All PROMs in the revision cohort were significantly worse than those in the primary rTSA cohort. Patient satisfaction rate in the revision cohort was significantly lower than the primary cohort (P<0.001). Complication (P=0.005) and revision rates (P=0.013) were significantly higher in the revision cohort, while scapular notching was similar. Patients undergoing revision of a failed aTSA to rTSA have worse clinical outcomes compared to those undergoing primary rTSA, including all PROMs, abduction, elevation, pain relief and patient satisfaction, with higher complication and revision rates. While patients in the revision group had significant improvements that exceeded the MCID and SCB, they do not achieve the same outcomes as patients who undergo primary rTSA.

Early assessment of vision-related quality of life predicts long-term spectacle-wear compliance

Non-compliance with spectacle wear undermines global health initiatives aimed at eliminating uncorrected refractive error—a preventable cause of visual impairment—by providing free or affordable spectacles to underserved populations. Non-compliance, however, is often identified too late, delaying effective health promotion strategies. This study evaluates the association between early-assessed vision-related quality of life (QoL) following spectacle correction and long-term compliance in adults. A comprehensive eye examination was conducted on 3052 university students to identify those visually impaired (presenting acuity ≥ Snellen 6/12 in the better eye) due to uncorrected refractive error. After refractive correction, participants achieving a best-corrected visual acuity of Snellen 6/6 completed the National Eye Institute 25-item Visual Function Questionnaire (NEI-VFQ-25) at baseline and within the first week of correction. A 6-month follow-up assessed compliance with spectacle wear. The average baseline NEI-VFQ-25 score improved from 67.35 (± 13.53%) to 90.56 (± 8.45%) with spectacle correction (P < 0.001) in the first week, with individual changes ranging from 2 to 70%. After 6 months, only 54 (47%) out of the 115 eligible participants (58 females; ages 18 to 29) were compliant. Following the adjustment for covariates, the results revealed that gains in NEI-VFQ-25 score below 40 were significantly associated with reduced compliance over the 6-month period (OR: 0.39, 95% CI: 0.06–0.99, P = 0.047). This supports an association between early vision-related QoL and long-term compliance. Scheduling a short follow-up to assess vision-related QoL within the first week after dispensing spectacles may help identify potential non-compliant wearers early, allowing for timely interventions.

Clinical and Radiographic Outcomes of a Long Cementless Monobloc Stem for Revision Total Hip Arthroplasty Due to Chronic Periprosthetic Infection

BackgroundA long cementless monobloc stem is widely used for aseptic loosening, with satisfactory five-to-ten-year outcomes reported. Nonetheless, related studies on chronic periprosthetic joint infection (PJI) are scant. This study evaluated the clinical and radiographic outcomes of the stem in two-stage revisions due to PJI. MethodsThis prospective multicenter cohort study consisted of patients from three medical centers who were enrolled in a single arm from January 2017 to May 2022. All patients were diagnosed with chronic PJI based on International Consensus Meeting (ICM) criteria and underwent two-stage revisions using a long monobloc cementless revision stem. Among 44 patients, 37 (12 women and 25 men) completed an average follow-up of 35.6 months (range, 14 to 75). The primary outcome was the stability of the stem; secondary outcomes included infection eradication, Harris hip score, leg length discrepancy, major complications, and isolated pathogens at intraoperative cultures. ResultsAt one year after revision, the infection-free prosthesis survival rate was 97.3% (95% CI [confidence interval]: 96.4 to 98.2%). At the last follow-up, the mean subsidence was 2.9 ± 2.1 mm (range, 0.8 to 4.8). Postoperative leg length discrepancy averaged −4.6 ± 4.9 mm (range, −16 to 0). The Engh score averaged 14.1 ± 6.9 (range, 0 to 22). The Harris hip score improved from a preoperative average of 35.7 ± 8.5 (range, 12 to 50) to 80.4 ± 9.3 (range, 58 to 92) at the 1-year postoperative follow-up (P < 0.01). ConclusionThe long cementless monobloc stem used in the current study presents a feasible option for two-stage revision in cases of chronic PJI. The bone ingrowth and stability could be observed within the short follow-up time.

Classification of Predictors of Rapid Development of Kidney Failure and Short-Term Changes in Concentration of Circulating Proteins.

Limited knowledge exists regarding short-term changes/increases in concentrations of circulating proteins (referred here as deltas) and rapid development of kidney failure (rapid KF) in diabetes mellitus. Concentrations of 452 circulating proteins were measured by OLINK proteomics platform at baseline and after a median interval of 3-4 years in 106 individuals with type 1 and 77 with type 2 diabetes in two case-control studies. During 10-year follow-up, 31 and 26 individuals, respectively, developed rapid KF. Deltas for 40 proteins predicted rapid KF in both studies. All were better predictors than delta urine albumin-creatinine ratio, and half were better than delta glomerular filtration rate. Comparing the delta proteins with 46 circulating proteins of which elevated baseline concentrations were predictors of rapid KF risk in our previous study, 61 unique proteins were identified. Among these proteins, 21 were good predictors of rapid KF only when measured at baseline (predictors of initiation), 15 were good predictors when measured as deltas (predictors of progression) and 25 were good predictors when both baseline and delta concentrations were used (predictors of initiation and progression). An index score, developed for the latter 25 proteins, provided superior prediction of rapid KF. A subset of these latter proteins was associated with apoptotic processes/tumor necrosis factor (TNF) receptor signaling pathways. Development of rapid KF in diabetes was preceded by elevated concentrations of multiple circulating proteins both at baseline and during short follow-up. Comparing baseline and short-term changes in concentrations of circulating proteins classified predictors of rapid KF risk into those associated with initiation, progression, or both. Predictors of both initiation & progression flagged apoptosis processes and TNF receptor signaling pathways. Multi-protein prognostic algorithms using proteins associated with both initiation and progression improved prediction of rapid KF risk beyond clinical variables.

Outcomes of patients treated with chemotherapy for breast cancer during pregnancy compared with nonpregnant breast cancer patients treated with systemic therapy.

Prior studies of patients treated for breast cancer during pregnancy (PrBC) report mixed outcomes and are limited by substandard treatment, small cohorts, and short follow-up. This study compared survival outcomes of PrBC patients treated with chemotherapy during pregnancy with nonpregnant patients matched by age, year of diagnosis, stage, and subtype. PrBC patients treated from 1989 to 2022 on prospective institutional protocols were eligible. Disease-free survival (DFS), overall survival (OS), and progression-free survival (PFS) were estimated using the Kaplan-Meier method and multivariable Cox proportional hazards regression. Among 143 PrBC and 285 nonpregnant patients, median follow-up was 11.4 years. Survival differences were statistically significant, with median DFS and OS not attained for PrBC patients versus 5.6 years (95% confidence interval [CI], 3.6-15.4; p=.0001) and 19.3 years (95% CI, 14.1-not estimated; p=.0262) for nonpregnant patients, respectively. Median PFS was 24.1 years (95% CI, 15.8-not estimated) for PrBC patients versus 8.4 years (95% CI, 6.4-10.9) for the nonpregnant cohort (p=.0008). Study cohort was associated with DFS, PFS, and OS in multivariable analyses, with the nonpregnant cohort having increased risks of disease recurrence (hazard ratio [HR], 1.91; 95% CI, 1.33-2.76; p=.0005) and disease progression or death (HR, 1.68; 95% CI, 1.19-2.39; p=.0035), and shorter OS (HR, 1.52; 95% CI, 1.01-2.29; p=.0442). These data suggest that PrBC patients treated with chemotherapy during pregnancy have at least comparable, if not superior, outcomes than nonpregnant patients with similar age, cancer stage, and subtype. Analyses excluding patients with postpartum breast cancer were unable to be performed and are a priority for future confirmatory studies.

Preclinical assessment of transcatheter-delivered expandable endoluminal polymeric graft fabricated by electrospinning of microfiber

Abstract Background Matrix fabricated from electrospinning of micro fibre of polyester is porous and permeable to blood, facilitates cell infiltration and late resorption of the biodegradable material. This biomaterial opens an avenue of research in recreating a novel and favourable endoluminal lining in diseased vessel. Previous preclinical work has shown that implants in aorta of rodents generate layers of endoluminal elastin. In humans, one of the most impervious arteries to atherosclerosis is the intra-thoracic artery; therefore, an attempt to induce similar structures with an implantable device was made. Methods For this study, novel tissue-engineered vascular grafts (T-TEVGs) were used in a preclinical rabbit iliac artery model. It was made of resorbable polyester biomaterial processed into fibrous tubular conduits. These T-TEVGs were implanted percutaneously. In total, twelve T-TEVGs in iliac arteries of nine rabbits were implanted. Follow-up were conducted on five rabbits with eight T-TEVGs at three months, two rabbits with two T-TEVGs at six months, and two rabbits with two T-TEVGs at twelve months. At follow-up, percutaneous optical coherence tomography (OCT) was performed, and OCT-derived luminal vessel wall dimensions and fractional flow reserve (OFR) derived from OCT were assessed. Results The overall pooled analysis at different timepoints on follow-up, documented an average MLA of 1.74±0.48mm2, average of proximal and distal reference area of 4.55±0.99 mm2, average area stenosis of 61±12%, and mean OFR value of 0.96±0.03 (OFR ranging from 0.89 to 0.99). There was a moderate positive correlation between minimum lumen area and OFR (r=0.590, p&amp;lt; 0.01). There was a strong negative correlation between percentage area stenosis and OFR (r= - 0.846, p&amp;lt; 0.01). At no timepoint in follow-up and in every vessel analysed, OFR value was lower than 0.89, suggesting that none of these vessels exhibited flow-limiting narrowing. Our study has a few limitations. 1) The preclinical model is a non-atherosclerotic rabbit; 2) There was no barotrauma prior to the implantation of the device; 3) Limited sample size, short and medium follow-up duration, and pooling of assessment at different timepoints. Conclusion The current study shows the durability and favourable hemodynamics of this bioresorbable fibrillated scaffold at short and medium term follow-up, supporting the potential utility of T-TEVEGs for peripheral human artery revascularisation. Long-term follow-ups are mandatory to confirm the durability of these results. Histopathology of this preclinical model should confirm the endoluminal elastin as previously documented in rodents (rats) and will be presented at the time of the congress.

Symptoms trend in patients with obstructive hypertrophic cardiomyopathy treated with disopyramide

Abstract Background In obstructive hypertrophic cardiomyopathy (HOCM) medical intervention becomes necessary when symptoms coexist, whereas invasive septal reduction therapy (SRT) is indicated in presence of NYHA class &amp;gt;II, although optimized medical therapy. Thus, if SRT is avoided by medical therapy patient should be considered responder. However, due to inconsistency on definition of responders, effectiveness of medical therapy among data are conflicting. In addition, only short follow-up (FU) is available for analyses. Purpose To address this, we conducted a retrospective analysis in two HCM centers, both defining responders based on guidelines recommendations. Methods 62 symptomatic HOCM patients (43% women, age 52±14 years) with LVOTG ≥50 mmHg at rest or during provocation, were recruited from two HCM Italian centers. Disopyramide was added as second-line therapy. Responders were those reaching at least NYHA class II, if &amp;gt;II at baseline and those reaching NYHA class I or with stabilization of symptoms if in NYHA II class at baseline. Results At FU, (mean 4.4 years, IQR 1.1-6.6 years), 47 patients (76%) were responders, whereas 15(24%) patients were no-responders. Changes in NYHA class from baseline to follow-up are reported in the Figure. There were no differences at baseline of clinical and echocardiographic data between responders and no-responders, whereas at FU responders showed a significant lower LVOTG than no-responders (43 ±32 vs 66 ±28 mmHg, respectively, p=0.013), with LVOTG &amp;lt;50 mmHg more represented in responders than in no-responders (75% vs 25%, respectively; p=0.004) (Figure). No side effects indicating discontinuation of the therapy were recorded. Conclusion Patients treated with disopyramide as second-line therapy showed a reduction in symptoms in a quite long-follow-up, avoiding SRT in up to 70% of them. Patients who might benefit the most from the therapy are those who reached LVOTG &amp;lt;50 mmHg during treatment.

Generalizability of SELECT to a contemporary cohort of cardiac surgical patients: analysis of the TRICS III Randomized Trial

Abstract Background The SELECT trial reported a significant reduction in cardiovascular (CV) outcomes with semaglutide amongst patients without diabetes who had pre-existing CV disease and a body-mass index (BMI) of 27 or greater. Patients undergoing cardiac surgery represent a high-risk subset of those with established CV disease, and may benefit from treatment with semaglutide. Purpose This study evaluated the generalizability of SELECT to a contemporary international cohort of cardiac surgical patients, and assessed whether differences between SELECT-eligible and non-eligible patients translated to altered risks of CV outcomes. Methods Present data was gathered from the TRICS III trial, a multicentre, randomized trial of restrictive versus liberal red-cell transfusion thresholds amongst 5243 cardiac surgical patients with a EuroSCORE I of ≥6. The proportion of cardiac surgical patients eligible for SELECT was determined by applying its selection criteria to the TRICS III cohort. Finally, baseline characteristics and outcomes stratified by SELECT eligibility were compared. Results A total of 4887 patients from the TRICS III cohort had available data for analysis, of which 452 (9.2%) were deemed to have been eligible for the SELECT trial. A comparison of baseline characteristics between SELECT-eligible and non-eligible patients are presented in Table 1; while SELECT-eligible patients were more likely to have preserved left ventricular function (71.7% vs. 61.0%), EuroSCORE I values were comparable between the two groups (7.8±2.1 vs. 7.9±1.9). The rate of a 3-point MACCE of Death, MI or stroke in the present cohort of SELECT-eligible patients undergoing cardiac surgery (16.6%) was numerically higher than those enrolled in SELECT receiving semaglutide (8.1%) or placebo (10.0%), despite the shorter follow-up (6 months vs. 39.8 months). Six month outcomes following cardiac surgery were similar regardless of SELECT eligibility (Figure 1); no difference in risk of outcomes was documented for the 3-point MACCE [SELECT Eligible vs. Non-eligible – 16.6% vs. 14.5%; OR 1.17 (0.9-1.53); P=0.24] and the TRICS III primary composite of Death, MI, Stroke, or New-Onset Renal Failure with Dialysis [17.0% vs. 17.0%; OR 1.0 (0.77-1.29); P=0.98]. There was a trend towards higher rates of MI at 6 months amongst SELECT-eligible patients, but this difference failed to reach statistical significance [8.5% vs. 6.3%; OR 2.0 (0.96-1.39); P=0.08). Conclusions In this large international cohort of contemporary cardiac surgical patients, nearly 10% would have met eligibility for SELECT. SELECT-eligible patients undergoing cardiac surgery in TRICS III had a numerically higher rate of MACCE than those enrolled in SELECT, highlighting the high risk nature of this patient subgroup. However, amongst SELECT-eligible and non-eligible patients undergoing cardiac surgery, no significant difference in CV outcomes was uncovered.

Prevalence of high-risk plaque features on cardiac computed tomography scans in patients with a coronary artery calcium score of zero

Abstract Introduction Coronary artery calcium (CAC) score of zero (so-called "power of zero") is associated with a very low rate of major adverse cardiac events (MACE), especially during short and midterm follow-up. However, a CAC score of zero does not definitively exclude the presence of atherosclerotic plaques or obstructive coronary artery disease (CAD). The composition of atherosclerotic plaques and the frequency of high-risk plaque features in this population are not well described. Purpose We sought to characterize the composition of atherosclerotic plaques and assess the frequency of high-risk plaque features on contrast-enhanced computed tomography (CT) images in patients with a zero CAC score. Methods The study enrolled patients with stable chest pain suspected of CAD referred for coronary CT imaging and having a CAC score of zero. Coronary CT angiography images were assessed by an expert reader to identify atherosclerotic plaques and high-risk plaque features in all coronary arteries with a diameter ≥1.5mm. The coronary artery lumen and plaques were manually segmented, and the degree of stenosis was evaluated following the Coronary Artery Disease Reporting and Data System (CAD-RADS) criteria. The presence of four high-risk plaque features was identified: positive remodeling, spotty calcification, low-attenuation plaque, and napkin ring sign. Total plaque volume, percent atheroma volume, and plaque composition were quantified using dedicated software (Figure 1). Results A total of 145 patients (mean age 54.2±12.1 years, 35.9% males) were included in the analysis. At least one coronary artery plaque was identified in 30 individuals (20.7%). 22 (15.2%), 7 (4.8%), and 1 (0.7%) patients were categorized into CAD-RADS 1, CAD-RADS 2, and CAD-RADS 3 categories, respectively. Among 30 patients with any coronary artery plaque, at least one high-risk feature was found in 10 individuals (33.3%), while 3 individuals (10.0%) had two features. Positive remodeling was found in 7 (23.3%), spotty calcification in 3 (10.0%), low-attenuation plaque in 3 (10.0%), and napkin ring sign in 0 patients, respectively (Figure 1). The mean total plaque volume was 48.2±54.3mm³, and the mean percent atheroma volume was 1.2±0.8%. Total plaque volume comprised low-attenuation (0.4%), fibro-fatty (58.9%), fibrous (39.4%), and calcified (1.3%) plaque volumes. Notably, in 3 (10.0%) individuals, the presence of calcified plaque was identified, which on non-contrast CT images did not meet the Agatston criteria for the CAC score. Conclusions Our study demonstrates a significant prevalence of atherosclerotic plaques and high-risk plaque features in patients with a CAC score of zero. Specifically, one in every five study participants had identifiable atherosclerotic plaque, with one in every three of those exhibiting one or more high-risk plaque features. The prognostic significance of these findings warrants further evaluation in studies with longitudinal follow-up.

Delirium and risk of incident cardiovascular events in elderly: data from a global health research network

Abstract Introduction Delirium is a common complication of acute medical disorders. A strong association between cardiovascular events and the occurrence of delirium has been recorded. Thus far, no data are available regarding the risk of incident cardiovascular events after delirium onset in older adults. Methods Using data from TriNetX, a global health federated research network, we performed a propensity score matched (PSM) analysis of older adults (age ≥65 years) admitted to the emergency department (ED) reporting delirium within two weeks, who were compared with those without delirium. We evaluated the occurrence of a composite outcome of cardiovascular events (myocardial infarction, ischemic stroke, heart failure, intracranial haemorrhage, ventricular arrhythmias, takotsubo syndrome, and atrial fibrillation) at 30 days and 1 and 3 years of follow-up. Results 4,480,229 patients were retrieved for the analysis, and 82,693 (1.8%) reported delirium. Before PSM, patients reporting delirium were older, with more prevalent comorbidities. After PSM, a total of 165,386 patients were included in the analysis (mean (SD) age 76.6 (9.0) years, 51.1% females). Throughout the entire follow-up period, the cumulative composite cardiovascular events outcome was significantly higher in patients which reported delirium [Red Line, Figure 1]. Delirium was associated with cardiovascular events at 30 days (HR 1.96, 95% CI 1.92-2.00) ,1 year (HR 1.75, 95% CI 1.72-1.78) and 3 years (HR 1.67, 95% CI 1.64-1.69) of follow-up, as well as for each of its components (Table 1). The presence of delirium was also associated with a higher risk of all-cause death and hospital access (Table 1), evaluated as secondary outcomes. In patients with delirium associated with the occurrence of incident cardiovascular events, there was a higher risk of recurrent cardiovascular events at 1 year (HR 3.11, 95% CI 2.92-3.31) and 3 years (HR 2.84, 95% CI 2.67-3.01) of follow-up. Conclusions In a large, unselected cohort of older adults admitted to ED, occurrence of delirium was associated with a higher risk of cardiovascular events, both in the short and long-term follow-up.Figure 1:Delirium and CV EventsTable 1:Cox Regression Analysis

Long-term changes in cardiac geometry and mechanics after bariatric surgery- insights from the FatWest study

Abstract Background Patients with severe obesity have a high prevalence of subclinical cardiac organ damage including impaired longitudinal and radial cardiac mechanics. Previous studies on the impact of bariatric surgery on cardiac remodeling, most of them with short patient follow-up, have yielded inconsistent results. Purpose To assess progressive changes in cardiac geometry and mechanics up to five years following bariatric surgery. Methods In the prospective Bariatric Surgery on the West Coast of Norway (FatWest) study, cardiac remodeling was assessed by 2D echocardiography preoperatively and at six months, one year and five years after Roux-en-Y gastric bypass in a cohort of 97 patients (44±10 years, 72% women, body mass index [BMI] 41.8±4.8 kg/m²). Excess weight loss (EWL) was calculated as: absolute weight loss/(initial weight-ideal weight)x100. Left ventricular (LV) size was assessed by the LV mass/ height^2.7, LV longitudinal mechanics by the peak global longitudinal strain (GLS) and radial mechanics by the midwall shortening (MWS). LV myocardial oxygen demand was estimated from the LV mass-wall stress-heart rate product. Right ventricular diameter was measured in the basal one-third of the ventricular cavity. Left atrial (LA) reservoir function was assessed by the LA emptying fraction. Results After a mean follow-up of 63±13 months, the average postoperative EWL was 66%. Overall, both right ventricular diameter, LV mass index, LV GLS, myocardial oxygen demand and LAEF (68% vs. 64%) improved significantly at the 5-year follow-up (all p&amp;lt;0.05), while MWS remained unchanged (Figure). Prevalence of normal LV geometry increased gradually from 56% to 80%, while that of LV hypertrophy fell from 36% to 16% (p&amp;lt;0.001). Analyses of temporal trends showed that improvement in BMI, LV mass and LV GLS occurred during the first postoperative year (Figure). In Cox regression analysis, a low 5-year GLS was associated with preoperative hypertension after adjustment for age, sex, preoperative diabetes mellitus, and postoperative changes in BMI, mean blood pressure and myocardial oxygen demand (p&amp;lt;0.01). In a similar linear model, after adjustment for the same covariates, LV mass index at the 5-year follow-up was independently related to the magnitude of the postoperative BMI reduction (R² = 0.58, p&amp;lt;0.001). Conclusion Ventricular size and longitudinal mechanics are significantly improved 5 years after bariatric surgery, with the reverse remodeling occurring during the first postoperative year. Residual abnormal 5-year LV geometry and mechanics are related to preoperative hypertension and suboptimal BMI reduction.Figure

Comparison of the clinical chemistry score to other biomarker algorithms for rapid rule-out of acute myocardial infarction and risk stratification

Abstract Background The clinical chemistry score (CCS) comprising high-sensitivity (hs) cardiac troponins (cTn), glucose and estimated glomerular filtration rate has been previously validated with superior accuracy for detection and risk stratification of acute myocardial infarction (AMI) compared to hs-cTn alone. Methods The CCS was directly compared to other biomarker-based algorithms for rapid rule-out and prognostication of AMI including the hs-cTnT limit-of-blank (LOB, &amp;lt;3 ng/L) or limit-of-detection (LOD, &amp;lt;5 ng/L) and the dual marker strategy (DMS) (copeptin &amp;lt;10 pmol/L and hs-cTnT ≤14 ng/L) in 1506 patients presenting to the emergency department (ED) with symptoms suggestive of acute coronary syndrome. Negative predictive values (NPV) and sensitivities for rule-out of AMI were assessed and outcomes included rates of the combined end-point of all-cause mortality, myocardial re-infarction and stroke within 12 months. Results NPVs of 100% (98.3-100%) could be found for a CCS=0, hs-cTnT LoB and hs-cTnT LoD with rule-out efficacies of 11.1%, 7.6% and 18.3% as well as specificities of 13.0% (9.9-16.6%), 8.8% (7.3-10.5%) and 21.4% (19.2-23.8%), respectively. A CCS≤ 1 achieved a rule-out in 32.2% of all patients with a NPV of 99.6% (98.4-99.9%) and specificity of 37.4% (34.2-40.5%) compared to a rule-out efficacy of 51.2%, NPV of 99.0 (98.0-99.5) and specificity of 59.7% (57.0-62.4%) for the DMS. Rates of the combined end-point of death/AMI within 30 days ranged between 0.0% and 0.5% for all fast-rule-out protocols. Conclusions The CCS enables a reliable rule-out of AMI with low outcome rates in short and long-term follow-up for a specific population of ED patients. However, compared to a single or dual biomarker strategy, the CCS rule-out is attenuated by a loss of specificity and lower efficacy. Thus, the clinical benefit of the CCS in clinical practice seems to be negligible.

Nivolumab+AVD in Advanced-Stage Classic Hodgkin’s Lymphoma

BackgroundIncorporating brentuximab vedotin into the treatment of advanced-stage classic Hodgkin’s lymphoma improves outcomes in adult and pediatric patients. However, brentuximab vedotin increases the toxic effects of treatment in adults, more than half of pediatric patients who receive the drug undergo consolidative radiation, and relapse remains a challenge. Programmed death 1 blockade is effective in Hodgkin’s lymphoma, including in preliminary studies involving previously untreated patients.MethodsWe conducted a phase 3, multicenter, open-label, randomized trial involving patients at least 12 years of age with stage III or IV newly diagnosed Hodgkin’s lymphoma. Patients were randomly assigned to receive brentuximab vedotin with doxorubicin, vinblastine, and dacarbazine (BV+AVD) or nivolumab with doxorubicin, vinblastine, and dacarbazine (N+AVD). Prespecified patients could receive radiation therapy directed to residual metabolically active lesions. The primary end point was progression-free survival, defined as the time from randomization to the first observation of progressive disease or death from any cause.ResultsOf 994 patients who underwent randomization, 970 were included in the intention-to-treat population for efficacy analyses. At the second planned interim analysis, with a median follow-up of 12.1 months, the threshold for efficacy was crossed, indicating that N+AVD significantly improved progression-free survival as compared with BV+AVD (hazard ratio for disease progression or death, 0.48; 99% confidence interval [CI], 0.27 to 0.87; two-sided P=0.001). Owing to the short follow-up time, we repeated the analysis with longer follow-up; with a median follow-up of 2.1 years (range, 0 to 4.2 years), the 2-year progression-free survival was 92% (95% CI, 89 to 94) with N+AVD, as compared with 83% (95% CI, 79 to 86) with BV+AVD (hazard ratio for disease progression or death, 0.45; 95% CI, 0.30 to 0.65). Overall, 7 patients received radiation therapy. Immune-related adverse events were infrequent with nivolumab; brentuximab vedotin was associated with more treatment discontinuation.ConclusionsN+AVD resulted in longer progression-free survival than BV+AVD in adolescents and adults with stage III or IV advanced-stage classic Hodgkin’s lymphoma and had a better side-effect profile. (Funded by the National Cancer Institute of the National Institutes of Health and others; S1826 ClinicalTrials.gov number, NCT03907488.)

Full pulpotomy versus root canal therapy in mature teeth with irreversible pulpitis: a randomized controlled trial

BackgroundVital pulp therapy (VPT) is recommended as an alternative treatment to root canal therapy (RCT) for management of teeth with carious pulp exposure. This randomized clinical trial aimed to compare the outcomes and postoperative pain, and to evaluate the time and cost after full pulpotomy (FP) and RCT in mature molar teeth with irreversible pulpitis (IP).MethodsA total of 160 mature molar teeth with IP were randomly divided into two treatment groups. The FP group (test group) was treated with FP using iRoot BP Plus by an endodontist, the RCT group (control group) was treated with RCT using iRoot SP as sealer by the same endodontist. Pain was recorded preoperatively and daily until day 7 postoperatively. The treatment time and cost were recorded. Clinical and radiographic assessments were collected, and pulp sensibility tests were done by electric pulp test (EPT) at 3-, 6-, 12- month postoperatively. Data were analyzed through chi-square test, Mann-Whitney U test, Fisher exact and independent t test.ResultsFP and RCT had comparable success rates (Clinical, 97.3% vs. 98.6%; radiographic, 93.3% vs. 94.6%) (P > 0.05). Pain levels decreased over time from day 1 to day 7 postoperative in both groups, and the FP group had larger reductions in pain intensity than RCT at day 1 (P < 0.05). In the FP group, there were 5, 3 and 3 unresponsive teeth with EPT at 3-, 6- and 12- month follow-ups, respectively. The treatment time and cost in the FP group were significantly lower than in the RCT group (P < 0.05).ConclusionsFP could be an appropriate alternative treatment for management of mature teeth with IP in short follow-up.Trial registrationThe trial was registered in Chinese Clinical Trial Registry (ChiCTR2200063380 at 05/09/2022).

The risk of diabetes and HbA1c deterioration during antipsychotic drug treatment: A Danish two-cohort study among patients with first-episode schizophrenia.

Antipsychotics increase the risk of developing diabetes, but clinical trials are not generalizable with short follow-up, while observational studies often lack important information, particularly hemoglobin A1c (HbA1c). We followed two Danish cohorts with schizophrenia. First, using Danish nationwide registers, we identified all individuals diagnosed with first-episode schizophrenia (FES) between 1999 and 2019 (n = 31,856). Exposure was a redeemed prescription for an antipsychotic, and the outcome was diabetes, defined via hospital-based diagnosis and redeemed prescriptions for glucose-lowering drugs. Adjusted Cox regression calculated hazard rate ratios (HRR). Second, using data from the Central Denmark Region, we identified all individuals diagnosed with FES from October 2016 to September 2022 (n = 2671). Using a within-subject design, we analyzed the change in HbA1c during the 2 years after initiation of specific antipsychotics compared to the 2 years before. In the nationwide cohort, 2543 (8.0%) individuals developed diabetes (incidence rate = 9.39 [95% CI = 9.03-9.76] per 1000 person-years). Antipsychotics, compared to periods without, were associated with an increased risk of developing diabetes (HRR = 2.04, 95% CI = 1.75-2.38). We found a dose-response association, particularly for second-generation antipsychotics, and different risk rates for specific antipsychotics. In the Central Denmark Region cohort, a total of 9.2% developed diabetes but mean HbA1c levels remained stable at 37 mmol/mol during the 2 years after initiation of antipsychotic medication. This comprehensive real-world two-cohort study emphasizes that diabetes affects almost 10% of patients with FES. Antipsychotics increase this risk, while HbA1c deterioration requires longer treatment. These findings are important for clinicians and young patients with FES.

The use of focal therapy for the treatment of prostate cancer in Canada: Where are we, how did we get here, and where are we going?

Focal therapy is an emerging treatment for localized prostate cancer. The objectives of this review were to: 1) review how focal therapies are regulated and approved; 2) summarize the scope and quality of the literature regarding safety, efficacy, and side-effects; and 3) outline ongoing clinical trials of focal therapy in Canada. Using the PRISMA framework for scoping reviews, we searched PubMed, Embase, and Cochrane from 2021-2024, complementing Hopstaken et al's search up functional and oncologic outcomes. Additionally, we examined the FDA database for regulatory details and ongoing trials in Canada via ClinicalTrial.gov. FDA approval for prostate tissue ablation was granted to high-intensity focused ultrasound (HIFU) in 2015 via the de novo pathway; other therapies followed the 510(k) route, citing equivalence to predicate devices. Most studies are in early stages, primarily single-arm, prospective cohort designs. Oncologic outcomes like cancer detection and survival rates, alongside functional data, such as adverse events and erectile function, were assessed. Recurrence-free survival at 48 months ranged from 58-92%, pad-free rates were greater than 95%, and rates of new-onset erectile dysfunction were variable, ranging from no change to 50%. Rates of serious adverse events (SAEs) were low, ranging from 0-14%. Three Canadian clinical trials are actively enrolling participants, and five private clinics were found offering private HIFU, irreversible electroporation (IRE), or transurethral ultrasound ablation (TULSA). Focal therapy technologies have gained regulatory approval for prostate tissue ablation, and, aside from provincial support for cryoablation in Alberta, are available to Canadians through private payment or clinical trials. Many studies demonstrate promising cancer control and impressive functional outcomes but are limited by their short followup and lack of comparator group. Clinical trial or registry participation should be prioritized to ensure an evidence-based integration into current prostate cancer treatment approaches.

6913 Clinical Prognosis in Patients with Thyroid Nodules Expressing PPAR-Gamma Gene Fusion on Thyroid FNA Cytology

Abstract Disclosure: R. Hammoudeh: None. E. Morariu: None. A. Wald: Other; Self; Technical consultant to Sonic Healthcare USA.. W.R. Doerfler: None. Y. Linwah: None. M. Nikiforova: Owner/Co-Owner; Self; Owner of intellectual property related to ThyroSeq, receive royalties through the University of Pittsburgh; consultants for Sonic Healthcare USA. Y.E. Nikiforov: Owner/Co-Owner; Self; Owner of intellectual property related to ThyroSeq, receive royalties through the University of Pittsburgh; consultants for Sonic Healthcare USA. Background: PPARG rearrangements, typically PAX8-PPARG, are common genetic alterations in follicular thyroid carcinoma and follicular variant of papillary thyroid carcinoma (FVPTC). Most tumors appear to be indolent, however distant metastasis has been reported. The aim of this study was to determine the prevalence and type of malignancy in a series of thyroid nodules positive for PAX8 rearrangement in thyroid fine-needle aspiration (FNA) samples. We also aimed to evaluate the impact on patient management, prognosis and outcomes. Methods: Thyroid nodules positive for PAX8 fusion on ThyroSeq v2 and v3 genomic classifier testing of FNA samples from May 2008 to February 2022 were identified. Clinical data was obtained by retrospective chart review. Results: Overall, 44 nodules positive for PAX8/PPARG fusion were identified. None of these nodules expressed additional genetic mutations on molecular testing. Surgical pathology was available for 40 patients, which identified 35 (87.5%) malignant, 3 NIFTP (7.5%), and 2 benign (5%) lesions. In the malignant group, FNA cytology revealed 1 (2.8%) benign, 13 (37.1%) AUS/FLUS, 12 (34.2%) suspicious for SFN/FN, 5 (14.3%) suspicious for PTC and 4 were not classified. In the non-malignant group, FNA cytology revealed 2 (40%) benign, 2 (40%) AUS/FLUS, 1 (20%) SFN/FN. With regards to surgical intervention, 30 (75%) patients had total thyroidectomy and 10 (25%) underwent lobectomy, of which 8 were followed by completion thyroidectomy. Among the malignant and non-malignant groups, there was no difference in sex (82.8% vs 100% female, p=1), age (43.6 vs 50.2 years, p=0.2), or tumor size on surgical pathology (3.26 vs 4 cm, p=0.23). In the malignant group, histology showed 30 (85.7%) FVPTC, 2 (5.7%) conventional PTC, 2 (5.7%) follicular carcinoma and 1 (2.9%) solid variant PTC. Of the FVPTC group, 9 had oncocytic cell features, 3 focal solid patterns, and 1 showed focal solid growth and progression to poorly differentiated thyroid carcinoma. Only 1 showed lymphatic invasion, 10 showed angioinvasion. Following the ATA thyroid cancer risk stratification, 23 (65.7%%) had low risk, 9 (25.7%) intermediate risk and 3 (8.6%) high risk. 18 patients in the malignant group underwent RAI ablation. Average follow up for the malignant nodules was 49.7 months (0-170). 1 had suspected recurrence on thyroid ultrasound after a year. No evidence of distant metastasis was documented. Conclusions: The majority of thyroid nodules with PAX8/PPARG rearrangement found on FNA were cancers, predominantly follicular variant PTC, and some were benign or NIFTP. The majority were low risk, but intermediate and high-risk cancers with more aggressive histology, angioinvasion, and poorly differentiated cancer were also identified. While only one recurrence was identified on short follow-up, longer follow-up duration is required for better understanding the behavior of these tumors. Presentation: 6/3/2024

Catching the Silent Culprits: TERT Promoter Mutation Screening of Minimally Invasive Follicular and Oncocytic Thyroid Carcinoma in Clinical Practice.

De-escalation of thyroid cancer treatment is crucial to prevent overtreatment of indolent disease, but it remains important to identify clinically aggressive cases. TERT promoter mutations are molecular events frequently associated with high-risk thyroid tumors with poor outcomes and may identify cases at risk of dissemination. In various international guidelines, small minimally invasive follicular thyroid carcinoma and oncocytic thyroid carcinoma (miFTC/miOTC) are classified as low-risk lesions and are not recommended adjuvant treatment. Our study aimed to explore the association between size-based risk assessment and TERT promoter mutations. Between 2019 and May 2024, 84 miFTCs/miOTCs diagnosed at our department underwent digital droplet PCR analysis targeting TERT promoter mutational hotspots C228T and C250T in clinical routine. TERT promoter mutations were found in 10 out of 84 cases (11.9%). Mutated cases were pT1 (n = 1), pT2 (n = 3), or pT3 (n = 6). Patients with mutated tumors were older compared to patients with wild-type tumors (median age of 71years vs. 57years, p = 0.041). There were no significant differences regarding patient sex, tumor size, Ki-67 labeling index, or the presence of distant metastases. Notably, 30% of mutations displayed variant allele frequencies < 10%, possibly suggesting subclonal events. To conclude, TERT promoter mutations in miFTCs and miOTCs were associated with higher patient age and were often suspected to be subclonal. However, they did not affect clinical outcomes, possibly due to short follow-up. Reflex testing for this genetic alteration in miFTCs and miOTCs could be justified regardless of tumor size, though the clinical benefit remains uncertain.