Patient-years Of Follow-up Research Articles

Percutaneous distal bicortical proximal phalanx osteotomy for second toe deformities – A two-year prospective cohort study

PurposeThe main purpose of our study was to evaluate satisfaction, recurrence, bone union and other complications after a minimum of two years follow-up in patients who had percutaneous claw and hammer (CHT) second toe correction utilizing a novel distal and bicortical proximal phalanx osteotomy (DBPPO). MethodsA minimum two-year follow-up prospective cohort study was conducted on consecutive patients with symptomatic CHT deformities of the second toe corrected with percutaneous surgery. Primary outcomes included satisfaction, recurrence, bony union, and other complication rates specific to the second toe deformity correction. Secondary outcomes included Metatarsophalangeal-Interphalangeal AOFAS scale and Visual Analogue Scale (VAS). ResultsBetween January and October 2020, 34 patients (43 feet) were clinically and radiologically evaluated pre and postoperatively at a mean of 26.6 months. Thirty-eight feet (88.4 %) were satisfied or very satisfied with their second toe deformity correction and 41 feet (95.3 %) would undergo surgery on this toe again. No deformity recurrence requiring revision was found. There were two complications (4.7 %): one toe (2.3 %) with persistent numbness and one (2.3 %) had a simple infection that resolved with oral antibiotics. All 43 s toe osteotomies demonstrated bony consolidation. Stiffness was reported in nine second toes (20.9 %), seven of them (77.8 %) having a rigid pre-operative deformity. Secondary outcomes demonstrated significant improvement in the mean ( ± standard deviation) AOFAS score which increased from 47.5 ± 17.9 preoperatively to 95.7 ± 7.7 postoperatively (p < .001). Mean VAS significantly improved from 4.9 ± 2.5 preoperatively to 0.3 ± 1.3 postoperatively (p < .001). ConclusionPercutaneous treatment of claw and hammer second toe deformities utilizing a DBPPO resulted in high levels of satisfaction with bony consolidation, no recurrence and low complication rates at two years follow-up.Level of evidence: Level II – Prospective cohort study

Comparison of range of motion between 2-year clinical outcomes and predictions of a static scapula preoperative planning software for reverse shoulder arthroplasty

BackgroundPreoperative planning has gained popularity in the management of reverse shoulder arthroplasty (RSA). Commercially available software provides 3-dimensional segmentation of scapula and humerus, as well as providing arc of motion for the implanted articulation and identifying potential areas of bony impingement. However, these software algorithms use a fixed scapula model, disregarding the preoperative clinical range of motion (C-ROM) of the patient, be it glenohumeral or scapulothoracic, as well as any soft tissue parameters. This study aims to compare the ROM based on preoperative planning software by using the implant position from postoperative computed tomography (CT) images (predicted ROM using preoperative planning software [P-ROM]), with the C-ROM assessed at minimum of 2 years of follow-up. MethodsPreoperative and postoperative CT scans of 46 patients who underwent primary RSA between 2017 and 2021 were analyzed. At the postoperative 2-year review, each patient was assessed for active ROM. Implant size and position based on operative notes and postoperative CT scans were used to replicate the performed surgery in the planning software. Abduction, flexion, and external rotation motion were simulated and recorded. The relationship between C-ROM and P-ROM was investigated using linear regression analysis, Pearson correlation coefficient, and paired t-test. ResultsP-ROM was significantly lower than C-ROM at 2 years postoperatively (P < .001), with an average discrepancy of 78° in abduction, 47° in flexion, and 37° in external rotation (C-ROM: abduction 155° ± 21° [80°-180°]; flexion 160° ± 17° [90°-180°]; external rotation 52° ± 14° [10°-80°] vs. P-ROM: abduction 77° ± 13° [53°-107°]; flexion 112° ± 25° [67°-180°]; external rotation 15° ± 21° [0°-79°]). The linear regression analysis indicated weak agreement between C-ROM and P-ROM (abduction R2 = 0.03; flexion R2 = 0.01; external rotation R2 = 0.04). Pearson’s correlation coefficients revealed weak correlations of −0.18, 0.03, and 0.21 for abduction, flexion, and external rotation, respectively. ConclusionP-ROM based on preoperative software in its current form does not allow the prediction of the C-ROM at 2 years of follow-up for patients undergoing RSA.

Outcomes of Particulated Juvenile Articular Cartilage and Association With Defect Fill in Patients With Full-Thickness Patellar Chondral Lesions.

Cartilage restoration procedures for patellar cartilage defects have produced inconsistent results, and optimal management remains controversial. Particulated juvenile articular cartilage (PJAC) allograft tissue is an increasingly utilized treatment option for chondral defects, with previous studies demonstrating favorable short-term outcomes for patellar chondral defects. To identify whether there is an association between defect fill on magnetic resonance imaging (MRI) with functional outcomes in patients with full-thickness patellar cartilage lesions treated with PJAC. Case series; Level of evidence, 4. A retrospective review of prospectively collected data was conducted on patients treated with PJAC for a full-thickness symptomatic patellar cartilage lesion between March 2014 and August 2019. MRI was performed for all patients at 6, 12, and 24 months postoperatively. Patient-reported outcome measures (PROMs) were obtained preoperatively and at 1, 2, and >2 years postoperatively. Clinical outcome scores-including the International Knee Documentation Committee (IKDC) score, the Kujala, the Knee injury and Osteoarthritis Outcome Score-Physical Function Short Form (KOOS-PS), the Knee Injury and Osteoarthritis Outcome Score-Quality of Life (KOOS-QoL), and the Hospital for Special Surgery Pediatric Functional Activity Brief Scale (HSS Pedi-FABS)-were analyzed and evaluated for a relationship with tissue fill on MRI. A total of 70 knees in 65 patients (mean age, 26.6 ± 8.1 years) were identified, of which 68 knees (97%) underwent a concomitant patellar stabilization or offloading procedure. Significant improvements were observed on all postoperative PROM scores at the 1-, 2-, and >2-year follow-up except for the Pedi-FABS, which showed no significant difference from baseline. From baseline to the 2-year follow-up, the KOOS-QoL improved from 24.7 to 62.1, the IKDC improved from 41.1 to 73.5, the KOOS-PS improved from 35.6 to 15, and the Kujala improved from 52 to 86.3. Imaging demonstrated no difference in the rate of cartilage defect fill between the 3-month (66%), 6-month (72%), 1-year (74%), and ≥2-year (69%) follow-ups. No association was observed between PROM scores and the percent fill of cartilage defect on MRI at the 1- and 2-year follow-up. PROM scores were significantly improved at the 2-year follow-up in patients who underwent PJAC for full-thickness patellar cartilage defects. On MRI, a cartilage defect fill of >66% was achieved by 3 months in most patients. In our sample, PROM scores were not significantly associated with the defect fill percentage at the short-term follow-up.

#1466 Age- and kidney function-dependent life expectancy of patients after COVID-19

Abstract Background and Aims The life expectancy among survivors of SARS-CoV-2 infection may be influenced by age, pre-existing health conditions, and the severity of the initial infection. This study aimed to investigate the life expectancy in patients that survived the acute phase of COVID-19 and the association with kidney function. Method Survival data of 649 unvaccinated patients from our previous study “Prospective Validation of a Proteomic Urine Test for Early and Accurate Prognosis of Critical Course Complications in Patients with SARS-CoV-2 Infection” (CRIT-COV-U) [1] was collected until December 2023 in six different countries. These patients had been recruited within the first and second wave in 2020-2021 (mostly infected with wild-type virus) and had survived the acute phase of COVID-19 (CritCov-U study period 21 days after infection). The age dependent death rate in this cohort was compared to age- and sex-matched data of non-SARS-CoV-2 infected patients (n = 5192) extracted from human urinary database. The association of chronic kidney disease biomarker CKD273 with mortality was investigated in both cohorts using Kaplan-Meier analysis. Cox-regression analysis was used to assess variables associated with mortality in the COVID-19 population. Results Mortality was age dependent in both cohorts and markedly higher in patients who had survived the acute phase of COVID-19 in comparison to non-infected individuals (Fig. A-E). Within the first year after infection, mortality was up to 16.5 times higher in patients younger than 50 years in comparison to non-infected controls. Kidney status estimated by the CKD273 score was associated with a poor outcome in both COVID-19 patients and age- and sex-matched controls, respectively (Fig. F-G). The hazard ratio (HR) for mortality during the first year of follow-up for patients with the highest CKD273 score was 12.7, a huge increase in comparison to HR = 6.6 in the matched control group. In the Cox-regression model, CKD273 significantly contributed to death prediction, next to age and COVID-19 severity score at baseline. Conclusion SARS-CoV-2 infection during the first and second wave increased the risk of mortality in the follow-up period beyond the acute phase of the first 21 days. Kidney function appears to be a key element in the underlying molecular pathology of this process, indicating the importance of kidney-protective measures. Of note, among those who survived the acute phase of COVID-19, increase in mortality within the first year after infection compared to a non-infected control group was highest in the younger individuals.

#2427 A multi-targeted treatment approach to induce early remission in high-risk primary membranous nephropathy

Abstract Background and Aims A considerable proportion of primary membranous nephropathy (PMN) patients do not achieve early clinical remission with current immunosuppression regimens. The goal of the study was to evaluate efficacy and safety of the multi-targeted treatment regimen including rituximab, cyclophosphamide, and corticosteroids (all administered at low cumulative doses) (RCP) in PMN with antibodies to the phospholipase A2 receptor (anti-PLA2R). Method The study enrolled 30 high- or very-high risk PMN patients with persistent nephrotic syndrome (NS) and elevated anti-PLA2R in a prospective single-arm study of RCP treatment. The experimental protocol consisted of a single intravenous infusion of RTX (375 mg/m2) and methylprednisolone (500 mg), followed by oral prednisolone (1 mg/kg) tapered rapidly at 10 mg per week and discontinued at week 49. An additional RTX infusion at the same dose was given during weeks 8-12, 20-24, and 32-36 if complete remission was not achieved and peripheral CD19+ cell exceeded 5 cells/μl. Four intravenous infusions of CYC were administered at a dose of 7.5 mg/kg every other week, in weeks 1, 3, 5, and 7. The effectiveness of RCP was compared to that of historic controls who received either rituximab-based therapy (RTX, n = 15) or cyclosporine+corticosteroids (CSA, n = 42). The primary outcomes measured were complete clinical remission (CR), overall remission (OR, which combines complete and partial remission) at month 12 after treatment initiation, and the time to clinical remission. Cox regression models were used to analyse the effect of RCP therapy on the probability of remission. Furthermore, we conducted comparative time-to-remission analyses in the RCP group and controls after propensity score (PS) matching. Results The RCP group exhibited higher OR and CR rates at 12 months (97% and 60%) compared to the RTX group (60% and 7%, P≤0.009) and the CSA group (50% and 24%, P≤0.003) (Fig. 1A,B). The median time to OR was shorter in the RCP group (2.8 (1.6–3.9) months) than in the RTX group (7.1 (3.4–17.5) months, P = 0.008) and the CSA group (7.3 (6.0–13.6) months, P &amp;lt; 0.001) (Fig. 1A). In the adjusted Cox regression, the hazard ratios for OR and CR attainment for RCP compared to other treatments were 5.2 (95% CI: 2.8–9.6) and 4.8 (95% CI: 2.2–10.3), respectively. These results were confirmed by comparative analyses of propensity score-matched groups. Only one serious adverse event (SAE) occurred in the RCP group during the 56 patient-year follow-up. Conclusion RCP therapy is considered effective and safe for inducing early remission in high-risk PMN patients.

Left bundle branch pacing and cardiac remodeling in HF patients with type 2 diabetes mellitus: epigenetic pathways and clinical outcomes.

Left bundle branch (LBB) pacing could achieve cardiac resynchronization therapy (CRT) in patients who cannot be resynchronized via the placement of the left ventricle (LV) lead into the coronary sinus. LBB pacing could improve cardiovascular outcomes in heart failure (HF) patients with LBB block who are affected by type 2 diabetes mellitus (T2DM). LBB pacing could increase the number of CRT responders and lead to the best clinical outcomes in HF patients with T2DM, inducing cardiac remodeling and improving left ventricle ejection fraction (LVEF) via microRNA (miR) modulation. In a multicenter observational study, we enrolled 334 HF patients with LBB block and an indication to receive LBB pacing for CRT. In these patients, we evaluated the CRT responder rate, clinical outcomes, and miR expression at 1 year of follow-up. At 1 year of follow-up, we had 223 responders (66.8%), 132 hospitalizations for HF (39.5%), 24 cardiac deaths (7.2%), and 37 all-cause deaths (11.1%), with a higher rate of HF hospitalizations (77 (69.4%) vs 55 (24.7%), p < 0.05), and cardiac deaths (13 (11.7% vs 11 (4.9%), p < 0.05) in non-responders vs responders. At the end of follow-up, we found the lowest expression of miR-26, miR-29, miR-30, miR-92, and miR-145 in LBB-pacing non-responders vs responders (p < 0.05), and a direct correlation between miR-30 (0.340, [0.833-1.915]; p 0.001), the 6-minute-walking test (6MWT; 0.168, [0.008-0.060]; p 0.011), angiotensin-receptor-neprilysin inhibitors (ARNI; 0.157, [0.183-4.877]; p 0.035), sodium-glucose-transporter-2 inhibitors (0.245, [2.242-7.283]; p 0.001), and LVEF improvements. C reactive protein (CRP) inversely correlated with LVEF improvement (-0.220, [-(0.066-0.263)]; p 0.001). ARNI (1.373, CI 95% [1.007-1.872], p 0.045), miR-30 (2.713, CI 95% [1.543-4.769], p 0.001), and 6MWT (1.288, CI 95% [1.084-1.998], p 0.001) were predictors of LBB pacing responders at 1 year of follow-up. LBB-pacing responders evidenced miR modulation, which was linked to significant improvement of the cardiac pump. Specifically, miR-30 was linked to cardiac pump improvement and predicted responders at 1 year of follow-up in patients with T2DM.

Contemporary Predictors of Major Adverse Cardiovascular Events Following Percutaneous Coronary Intervention: A Nationally Representative US Sample.

Background: Patient outcomes after percutaneous coronary intervention (PCI) have improved over the last 30 years due to better techniques, therapies, and care processes. This study evaluated contemporary predictors of post-PCI major adverse cardiovascular events (MACE) and summarized risk in a parsimonious risk prediction model. Methods: The Cardiovascular Patient-Level Analytical Platform (CLiPPeR) is an observational dataset of baseline variables and longitudinal outcomes from the American College of Cardiology's CathPCI Registry® and national claims data. Cox regression was used to evaluate 2-6 years of patient follow-up (mean: 2.56 years), ending in December 2017, after index PCI between 2012 and 2015 (N = 1,450,787), to examine clinical and procedural predictors of MACE (first myocardial infarction, stroke, repeat PCI, coronary artery bypass grafting, and mortality). Cox analyses of post-PCI MACE were landmarked 28 days after index PCI. Results: Overall, 12.4% (n = 179,849) experienced MACE. All variables predicted MACE, with cardiogenic shock, cardiac arrest, four diseased coronary vessels, and chronic kidney disease having hazard ratios (HRs) ≥ 1.50. Other major predictors of MACE were in-hospital stroke, three-vessel disease, anemia, heart failure, and STEMI presentation. The index revascularization and discharge prescription of aspirin, P2Y12 inhibitor, and lipid-lowering medication had HR ≤ 0.67. The primary Cox model had c-statistic c = 0.761 for MACE versus c = 0.701 for the parsimonious model and c = 0.752 for the parsimonious model plus treatment variables. Conclusions: In a nationally representative US sample of post-PCI patients, predictors of longitudinal MACE risk were identified, and a parsimonious model efficiently encapsulated them. These findings may aid in assessing care processes to further improve care post-PCI outcomes.

Switching patterns of biological drugs in patients with psoriasis and psoriatic arthritis: insight from the VALORE database network

ABSTRACT Background Switch patterns among different biologics and from originators to biosimilars (and vice versa) can be complex in patients with psoriasis (PsO) and psoriatic arthritis (PsA). Objective The aim of this study was to describe switching patterns of biological drugs in PsO/PsA patients and to explore predictors of multiple switches and switch-back. Research design and methods A large-scale retrospective cohort study was conducted using the Italian VALORE database. Bio-naïve users treated for PsO/PsA during 2010–2022 were included. Time to switch/swap and predictors of multiple switches and switch-back were analyzed. Results Thirty-thousand seven hundred bio-naïve users were included. At 3 and 5 years of follow-up, patients with at least one switch/swap were 37.1% and 47.8%, respectively. The median time to first switch/swap was significantly shorter (p< 0.001) for TNF-α inhibitors (2,068 days) than anti-IL (2,780 days). At 1 year of follow-up patients starting with IL-23 switched/swapped biological therapy less frequently than those with anti-IL-12/23 and anti-IL-17 (4.9% vs. 8.7% and 9.4%, respectively). Patients starting with anti-IL-12/23 reported a significantly lower risk of multiple switches and switch-back (0.74, 95% CI, 0.67–0.83; 0.58, 95% CI, 0.44–0.77, respectively) than those with TNF-α inhibitors. Conclusions Patients with PsO/PsA starting with TNF-α inhibitors switch/swap more rapidly and frequently than those with anti-IL, which are also associated with a reduced risk of multiple switches during follow-up.

Radiographic study of direct anterior approach hip arthroplasty: a 10–15 year follow-up of Chinese patients

BackgroundControversy remains over whether different surgical approaches exert an impact on the component positioning in total hip arthroplasty. We conducted a retrospective study to reveal the long-term position of prostheses in the first group of patients in China who underwent direct anterior hip arthroplasty.MethodsCollected were data from 350 patients who underwent direct anterior hip arthroplasty between 2008 and 2013, including demographic information, imaging data, Harris hip scores, and surgical complications. Variables, measured radiographically or by CT, included hip offset, leg length discrepancy, component position, and stability within one week after surgery and at the last follow-up. The data were subjected to statistical analysis by using paired t-tests and Pearson chi-square tests.ResultsData were harvested by follow-up and self-reported questionnaires. The postoperative follow-up lasted for 13.1 years on average (minimum, 10 years; maximum, 15 years), and the overall survival rate of hip prostheses was 96.3%. The mean Harris score at the final follow-up was 91.8 points. After excluding patients with significant preoperative hip deformities, the incidence of postoperative limb inequality (> 5 mm) was 4.9% at the last follow-up, and the incidence of hip offset discrepancy (> 5 mm) was 14.6%. The overall proportion of the acetabular components located in the Lewinnek safe zone was 77.7%, whereas the proportion of femoral prostheses in the safe zone (< 3° inclination) was 94.0%. Based on the revised data and the last follow-up imaging, the total proportion of acetabular and femoral prostheses with a radiolucence of > 2 mm was 5.1%.ConclusionDirect anterior approach hip arthroplasty could achieve excellent component positioning and long-term prosthesis survival in patients without severe hip deformities.

Ten-year follow-up of posterior chamber phakic intraocular lens with central port design in patients with low and normal vault.

To assess the clinical outcomes and postoperative complications of the implantable collamer lens (ICL) with a central port throughout 10 years of follow-up in patients with low and normal vault. Fernández-Vega Ophthalmological Institute, Oviedo, Spain. Retrospective and comparative case series. This study included eyes that underwent a V4c ICL implantation with 10 years of follow-up. The eyes were divided into 2 groups according to the vault at 1 year postoperatively: vault <250 μm and between 250 μm and 800 μm. Uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), intraocular pressure (IOP), endothelial cell density (ECD), vault, complications, and secondary surgeries were analyzed. 37 and 90 eyes were enrolled in the low and normal-vault groups, respectively. No differences in UDVA, CDVA, and refraction were found between the groups over 10 years of follow-up. No cases developed ICL-induced anterior subcapsular opacity over the follow-up period. 2 (5.4%) and 8 (8.9%) eyes in the low and normal-vault groups, respectively, required ICL exchange. 1 (2.8%) and 2 (2.2%) eyes in the low and normal-vault groups, respectively, required excimer laser to correct residual refractive error. The IOP remained stable throughout the 10-year follow-up. The loss in ECD from that preoperatively to 10 years postoperatively was 3.8% and 4.5% in the low and normal-vault groups, respectively ( P = .4). No pigment dispersion glaucoma or other vision-threatening complications were reported. This study shows good long-term outcomes of the V4c ICL, supporting that the central hole provides safety to the procedure and prevents the potential risk associated with low vault.

TEN YEAR FOLLOW-UP OF PATIENTS WITH RESISTANT HYPERTENSION RANDOMIZED TO RENAL DENERVATION OR ANTIHYPERTENSIVE DRUG TREATMENT

Objective: Renal denervation (RDN) is a treatment option in resistant hypertension. The procedure is considered safe, although randomized trials only demonstrate a moderate blood pressure (BP) lowering effect, when considering medication adherence. Some observational studies describe reduction in BP several years after the procedure. The aim of the study was to describe long-term safety and potential benefits of RDN after ten years, compared to optimized drug treatment, measuring serum concentration of antihypertensive drugs to ensure adherence. Design and method: We report data from ten year follow-up of patients randomized to RDN (n=9) or drug adjustment (n=10). Initially the patients had treatment-resistant hypertension, defined as daytime systolic ambulatory BP &gt;= 135 mmHg after witnessed intake (directly observed therapy, DOT) of &gt;= 3 antihypertensive drugs including a diuretic and therefore considered as adherent. One year after RDN or drug adjustment, we optimized antihypertensive medication for all patients. Thereafter, patients received appropriate antihypertensive treatment in primary or secondary care, according to their BPs. Patients were informed of serum concentration measurements performed at the 7-year visit. At the 10-year visit, serum drug measurements before DOT and ambulatory BP measurement (ABPM) were used for evaluation of adherence. Antihypertensive agents were registered, glomerular filtration rate (eGFR) was estimated by the CKD-EPI formula using creatinine and Cystatin C, and renal arteries were examined by CT or MRI. Results: All living patients (n=18) attended the 10-year visit, now mean age 69 years, using 4±2 antihypertensive agents, with no difference between groups. Serum concentrations confirmed that all patients were adherent to reported medication. There were significant and similar BP reductions in both groups compared to baseline; daytime ABPM -22±15/9±8 mmHg in the RDN group, and -20±15/13±7 mmHg in the control group (figure). No patients developed renal artery stenosis. The decrease in eGFR was similar in both groups. Conclusions: To our knowledge this is the RCT with the longest follow-up supporting long-term safety of RDN in patients with resistant hypertension. Daytime ABPM improved during 10 years of follow-up, not explained by RDN, but due to adjustments in antihypertensive regimens and probably better adherence to medication.

Risk of acute pancreatitis among new users of empagliflozin compared to sulfonylureas in patients with type 2 diabetes: A post-authorization safety study.

This study was undertaken to evaluate the potential risk of acute pancreatitis with empagliflozin in patients with type 2 diabetes (T2D) newly initiating empagliflozin. Data from two large US claims databases were analyzed in an observational study of patients with T2D receiving metformin who were newly prescribed empagliflozin versus sulfonylurea (SU). Because dipeptidyl peptidase-4 inhibitors and glucagon-like peptide-1 receptor agonists have been associated with the risk of acute pancreatitis in some studies, patients on these agents were excluded. Using pooled analyses of data from the two databases (2014-2021), patients initiating empagliflozin were matched 1:1 within database to patients initiating SU using propensity scores (PS) that incorporated relevant demographic and clinical characteristics. Prespecified sensitivity analyses were performed for design parameters. The analyses identified 72 661 new users of empagliflozin and 422 018 new users of SUs, with both patient groups on concurrent metformin therapy. Baseline characteristics within treatment groups appeared to be similar across the 72 621 matched pairs. After mean follow-up of ~6 months, incidence rates of acute pancreatitis in the pooled matched cohort were 10.30 (95% confidence interval [CI] 9.29-11.39) events per 1000 patient-years (PY) for empagliflozin and 11.65 (95% CI 10.59-12.77) events per 1000 PY for SUs. On a background of metformin, patients newly initiating empagliflozin did not have an increased risk of acute pancreatitis compared with those initiating an SU (pooled PS matched hazard ratio 0.88 [0.76-1.02]) across 75621.42 PY of follow-up. The results of this voluntary post-approval safety study provide additional evidence that the use of empagliflozin for the treatment of T2D is not associated with an increased risk of acute pancreatitis.

Comparison of Dual vs. Triple Antithrombotic Therapy in Non-Valvular AF and Acute Coronary Syndrome: A Malaysian Cohort Study

Objectives: This study aimed to compare Dual Antithrombotic Therapy (DAT) and Triple Antithrombotic Therapy (TAT) concerning bleeding and thrombosis outcomes in Malaysian patients with non-valvular atrial fibrillation (NVAF) and acute coronary syndrome (ACS), considering demographic characteristics and comorbidities. Methodology: A retrospective observational cohort study was conducted at Hospital Serdang from January 1, 2020, to May 1, 2022. A total of 206 patients were selected via purposive sampling and divided into two groups. The TAT group received warfarin, clopidogrel, and aspirin, while the DAT group received warfarin and clopidogrel over a 1-year follow-up. Multivariate logistic regression analysis was employed. Results: A higher incidence of thromboembolic episodes was observed in the DAT group (24.3% vs. 8.7% in the TAT group; adjusted odds ratio (aOR) 4.53, 95% CI 1.806-11.379, P= 0.001), signifying a 4.5-fold increase in thromboembolic events in DAT compared to TAT. Conversely, more bleeding episodes were observed in the TAT group (25.2% vs. 15.5% in the DAT group; aOR 2.22, 95% CI 0.993-4.970, P= 0.52), although the difference was not statistically significant. Conclusion: The DAT protocol showed significantly more thrombosis episodes than the TAT protocol, while TAT exhibited a non-significant increase in bleeding events compared to DAT at one year follow-up in patients with NVAF and ACS.

Surgical Hip Dislocation in the Era of Hip Arthroscopy Demonstrates High Survivorship and Improvements in Patient-reported Outcomes for Complex Femoroacetabular Impingement.

Surgical Hip Dislocation in the Era of Hip Arthroscopy Demonstrates High Survivorship and Improvements in Patient-reported Outcomes for Complex Femoroacetabular Impingement.

Dynamic Prediction of Advanced Colorectal Neoplasia in Inflammatory Bowel Disease

Colonoscopic surveillance is recommended in patients with colonic inflammatory bowel disease (IBD) given their increased risk of colorectal cancer (CRC). We aimed to develop and validate a dynamic prediction model for the occurrence of advanced colorectal neoplasia (aCRN, including high-grade dysplasia and CRC) in IBD. We pooled data from six existing cohort studies from Canada, the Netherlands, the UK, and the USA. Patients with IBD and an indication for CRC surveillance were included if they underwent at least one follow-up procedure. Exclusion criteria included prior aCRN, prior colectomy, or an unclear indication for surveillance. Predictor variables were selected based on literature. A dynamic prediction model was developed using a landmarking approach based on Cox proportional hazard modelling. Model performance was assessed with Harrell's concordance-statistic (discrimination) and by calibration curves. Generalizability across surveillance cohorts was evaluated by internal-external cross-validation. The surveillance cohorts comprised 3,731 patients, enrolled and followed-up in the time period 1973-2021, with a median follow-up of 5.7 years (26,336 patient-years of follow-up); 146 individuals were diagnosed with aCRN. The model contained eight predictors, with a cross-validation median c-statistic of 0.74 and 0.75 for a 5- and 10-year prediction window, respectively. Calibration plots showed good calibration. Internal-external cross-validation results showed medium discrimination and reasonable to good calibration. The new prediction model showed good discrimination and calibration, however, generalizability results varied. Future research should focus on formal external validation and relate predicted aCRN risks to surveillance intervals prior to clinical application.

Impact of multimorbidity on the first ts/bDMARD effectiveness and retention rate after two years of follow-up in patients with rheumatoid arthritis from the BIOBADASER registry

BackgroundPatients with Rheumatoid Arthritis (RA) have a higher prevalence of comorbidities compared to the general population. However, the implications of multimorbidity on therapeutic response and treatment retention remain unexplored. Objectives: (a) To evaluate the impact of multimorbidity on the effectiveness of the first targeted synthetic or biologic disease-modifying antirheumatic drug (ts/bDMARD), in patients with RA after 2-year follow-up; (b) to investigate the influence of multimorbidity on treatment retention rate.MethodsPatients with RA from the BIOBADASER registry exposed to a first ts/bDMARDs were included. Patients were categorized based on multimorbidity status at baseline, defined as a Charlson Comorbidity index (CCI) score ≥ 3. A linear regression model, adjusted for sex and age, was employed to compare the absolute DAS28 score over time after ts/bDMARD initiation between the two groups. The Log-Rank test and Kaplan-Meier curve were used to compare the retention rates of the first ts/bDMARD between the groups.ResultsA total of 1128 patients initiating ts/bDMARD were included, with 107 (9.3%) exhibiting multimorbidity. The linear regression model showed significantly higher DAS28 (beta coefficient 0.33, 95%CI:0.07–0.58) over a two-year period in patients with multimorbidity, even after adjusting for age and sex. Finally, no differences in the ts/bDMARD retention rate were found between groups (median 6.94–6.96 years in CCI < 3 vs. 5.68–5.62 in CCI ≥ 3; p = 0.610).ConclusionsMultimorbidity in patients with RA was associated with greater DAS28 scores within the first two years after ts/bDMARD initiation, in comparison with patients without multimorbidity. A slightly shorter retention rate was found in patients with multimorbidity, although the difference was non-significant.

Epiretinal membrane development after Ex-Press glaucoma filtration device implant: 2-year results of a case control study

BackgroundThe most common retinal complications after glaucoma surgery are choroidal detachment, hypotony maculopathy, malignant glaucoma, vitreous hemorrhage, endophthalmitis and retinal detachment. However, if glaucoma surgery is a risk factor for the ERM development needs to be clarified. This study aims to assess the incidence of epiretinal membrane (ERM) in 2 years of follow-up in patients with primary open-angle glaucoma (POAG) treated with Ex-Press shunt implant.MethodsA prospective, consecutive, single-center, case–control study. We enrolled patients affected by POAG and scheduled for Ex-Press device implant with or without concomitant cataract surgery. The control group was the contralateral eyes which continues anti-glaucomatous eyedrops. Complete ophthalmologic evaluation and spectral-domain optical coherence tomography were performed before surgery, at 6 months and 24 months of follow-up.ResultsEighty-two eyes of 41 consecutive patients, 18 males and 23 females with a mean age of 70, 29 ± 8,45, were analyzed at 24 months. 39.1% of eyes developed ERM: 29.3% were cellophane macular reflex (CMR) and 9.8% were pre-macular fibrosis (PMF). In the control group, 19.5% of eyes developed ERM: 17.1% were CMR and 2.4% were PMF. No statistically significant difference was reported (p = 0.121) between treated and control group. ERM development did not affect significantly the central foveal thickness (260.13 ± 35.01 μm at baseline, 265.03 ± 34.90 μm at 6 months and 275.18 ± 33.31 μm at 24 months) and macular volume (7.75 ± 0.43 mm3 at baseline, 7.77 ± 0.48 mm3 at 6 months and 7.77 ± 0.46 mm3 at 24 months), remained comparable to reported average measures in healthy individuals during the follow-up. Concomitant cataract surgery did not increase the ERM incidence.ConclusionEx-Press implant may increase the ERM incidence regardless concomitant cataract surgery, accelerating or inducing a posterior vitreous detachment, such as other ocular surgical procedure. Nevertheless, the vast majority of ERM are CMR, not affecting the macular profile.

Incidence and risk factors of major cardiovascular events in rheumatoid arthritis and psoriatic arthritis: A population-based cohort study

ObjectiveTo evaluate the incidence and risk factors of major adverse cardiovascular events (MACE) in rheumatoid arthritis (RA) and psoriatic arthritis (PsA) patients. MethodsA population-based retrospective cohort of RA and PsA patients was identified in a citywide database. All patients recruited from Jan 2006 to Dec 2015 were followed until the end of 2018. The outcome was the occurrence of a first MACE. Covariates of interest included traditional cardiovascular (CV) risk factors, inflammatory markers and pharmacotherapies. The independent predictors of MACE were identified by the time-dependent cox proportional hazard models. ResultsA total of 13,905 patients (12,233 RA and 1,672 PsA) were recruited. After a total of 119,571 patient-years of follow-up, 934 (6.7%) patients developed a first MACE. RA and PsA patients had similar adjusted incidence (incidence rate ratio 0.96, 95 % CI 0.75–1.22, p = 0.767). After adjusting for traditional CV risk factors, the time-varying erythrocyte sedimentation (ESR) rate and C-reactive protein (CRP) levels, and the use of glucocorticoids were independently associated with higher risk of MACE in both the RA and PsA cohorts. In RA, the use of methotrexate and non-steroidal anti-inflammatory drugs (NSAIDs) were associated with fewer MACE. The use of biologic disease modifying anti-rheumatic drugs was not associated with MACE in both RA and PsA. ConclusionThe incidence of MACE was similar in RA and PsA. Systemic inflammation and glucocorticoid use independently increased the risk of MACE in inflammatory arthritis, while methotrexate and NSAIDs use were protective against the development of MACE in RA.

Biological Agents in the Treatment of Crohn's Disease: A Propensity Score-Matched Analysis From the Prospective Persistence Australian National IBD Cohort (PANIC3) Study.

Comparative effectiveness research provides data on the relative benefits and risks between treatments. In Crohn's disease (CD), however, there are few head-to-head studies comparing advanced therapies and none with long-term follow-up. Real-world effectiveness, defined by treatment persistence, obtained from prospective population-based patient cohorts, may help determine the best sequencing and positioning of biological agents. We analyzed the prospectively collected population-based Australian national Pharmaceutical Benefits Scheme dispensing data registry (2005-2019) for CD. There is no mandated biological agent prescribing order, and all citizens and permanent residents are eligible for treatment irrespective of insurance status. Propensity score matching was performed to reduce selection bias. There were 2,029 lines of therapy in 1,446 patients (median age 43 years, interquartile range 34-58, 44% male patients) over the 15-year period with 5,618 patient-years of follow-up. Per line of therapy, 915/2,029 (45.1%) patients used adalimumab, 722/2,029 (35.6%) used infliximab, 155/2,029 (7.6%) used vedolizumab, and 237/2,029 (11.7%) used ustekinumab. When used in biological agent-naive patients, there was no difference in persistence between any agent ( P > 0.05). Used after first line in biological agent-experienced CD, ustekinumab had significantly better persistence than non-ustekinumab biological agents ( P = 0.0018), vs anti-tumor necrosis factor (TNF) alpha therapy ( P = 0.006) or vedolizumab ( P < 0.001). Ustekinumab persistence was unaffected by prior biological agent exposure ( P = 0.51). After anti-TNF use, ustekinumab had superior persistence to an alternative anti-TNF agent ( P = 0.033) and to vedolizumab ( P = 0.026). Using a propensity score-matched analysis adjusted for age, immunomodulator use, and bio-exposed status, ustekinumab had superior persistence to anti-TNF ( P = 0.01). Multivariate predictors of worse persistence were the use of a non-ustekinumab biological agent (adjusted hazard ratio 2.10, P < 0.001), and bio-experienced status (adjusted hazard ratio 1.23, P < 0.001). This large national prospective database with nonhierarchical prescribing of biological agents did not identify superior persistence of any agent in bio-naive CD. However, for patients with bio-experienced CD, persistence was greater with ustekinumab.

Clinical features of coronary artery disease and 5-year survival of patients after myocardial infarction against the background of depressive disorders

Aim. To assess the features of the clinical picture of coronary artery disease (CAD) and the prognosis of patients with myocardial infarction with depressive disorder (DD).&#x0D; Materials and methods. We examined 101 patients with stable CAD who had myocardial infarction more than six months ago: 67 CAD patients with depression (Group 1) and 34 CAD patients without depression (Group 2). The clinical picture of CAD was assessed by complaints, angina self-monitoring diaries, and exercise tests. The presence and severity of DD was determined using psychometric scales: BDI (Beck Depression Scale), HADS (Hospital Anxiety and Depression Scale) and the opinion of a psychiatrist. Five-year survival information was obtained through telephone interviews with patients and their relatives.&#x0D; Results. In patients with CAD and DD in comparison with patients without DD self-monitoring diaries revealed more frequent angina attacks: 9 [6; 12] vs 6 [4; 7] per week (p=0.0001), the greater need for sublingual nitrates: 2 [0; 9] pills vs 0 [0; 4] pills (p=0.0001). DD significantly reduced exercise tolerance: 370 [250; 450] meters vs 435 [350; 500] meters using the six-minute walk test (p=0.04), according to the results of bicycle ergometry – 50 [25; 75] W vs 75 [50; 75] W (p=0.03). After 5 years of follow-up patients with comorbidities (CAD and DD) had a greater number of deaths: 13 (19.4%) vs 2 (5.9%), respectively, survived – 54 (80.6%) vs 32 (94.1%) (Gehan–Wilcoxon test, p=0.04).&#x0D; Conclusion. The comorbidity CAD and DD leads to a worsening of the clinical course of CAD and prognosis, which actualizes the need for verification of the diagnosis of DD and timely prescription of antidepressant therapy.