Three-year Follow-up Research Articles

Long-term outcome of percutaneous vertebroplasty versus conservative treatment for osteoporotic vertebral compression fractures: a retrospective cohort study with three-year follow-up.

Osteoporotic vertebral compression fractures (OVCF) appear to be more common as the population ages. Previous studies have found that percutaneous vertebroplasty (PVP) can achieve better short-term clinical outcomes than conservative treatment (CT) for OVCF. However, the long-term outcomes of PVP compared with CT for OVCF has been rare explored. This study was designed to explore the clinical outcomes of PVP or CT within 3 years after OVCF. This study reviewed the clinical outcomes of patients who underwent PVP or CT for OVCF in a single center from January 2015 to December 2019. The back pain visual analogue scale (VAS), Oswestry disability index (ODI) and satisfaction rate were compared between the two groups at baseline, 1 week, 1 month, 3 months, 6 months, 12 months, 24 months and 36 months after treatment. The baseline data including gender, age, bone mineral density, body mass index, back pain VAS, and ODI were not significantly different between the two groups. The back pain VAS and ODI of CT patients were significantly higher than those of PVP group at 1 week, 1 month, 3 months, 6 months and 12 months after treatment. The satisfaction rate in the PVP group were significantly higher than those in the CT group at 1 week, 1 month, 3 months and 6 months after treatment. Subsequently, the back pain VAS and ODI showed no significant difference between the two groups at 24 and 36 months. In addition, there was no significant difference in treatment satisfaction between the two groups at 36 months. There was no significant difference in the rate of new vertebral compression fractures between the two groups within 36 months after treatment. The clinical outcomes within 12 months after PVP and patient satisfaction rate within 6 months after PVP were significantly higher than CT. However, during 12 months to 36 months, this advantage generated by PVP was gradually diluted over time. Compared with CT, the long-term effect of PVP on OVCF should not be overestimated.

THE MEDIUM-TERM RESULTS OF ARTHROSCOPIC HIP SURGERY COMPARED WITH PHYSIOTHERAPY AND ACTIVITY MODIFICATION FOR THE TREATMENT OF FEMOROACETABULAR IMPINGEMENT SYNDROME: A MULTICENTRE RANDOMIZED CONTROLLED TRIAL

The primary treatment goal for patients with femoroacetabular impingement syndrome, a common hip condition in athletes, is to improve pain and function. In selected patients, in the short term following intervention, arthroscopic hip surgery is superior to a pragmatic NHS- type physiotherapy programme. Here, we report the three-year follow-up results from the FemoroAcetabular Impingement Trial (FAIT), comparing arthroscopic hip surgery with physiotherapy in the management of patients with femoroacetabular impingement (FAI) syndrome.Two-group parallel, assessor-blinded, pragmatic randomised controlled study across seven NHS England sites. 222 participants aged 18 to 60 years with FAI syndrome confirmed clinically and radiologically were randomised (1:1) to receive arthroscopic hip surgery (n = 112) or physiotherapy and activity modification (n = 110). We previously reported on the hip outcome score at eight months. The primary outcome measure of this study was minimum Joint Space Width (mJSW) on Anteroposterior Radiograph at 38 months post randomisation. Secondary outcome measures included the Hip Outcome Score and Scoring Hip Osteoarthritis with MRI (SHOMRI) score.Minimum Joint Space Width data were available for 101 participants (45%) at 38 months post randomisation. Hip outcome score and MRI data were available for 77% and 62% of participants respectively. mJSW was higher in the arthroscopy group (mean (SD) 3.34mm (1.01)) compared to the physiotherapy group (2.99mm (1.33)) at 38 months, p=0.017, however this did not exceed the minimally clinically important difference of 0.48mm. SHOMRI score was significantly lower in the arthroscopy group (mean (SD) 9.22 (11.43)) compared to the physiotherapy group (22.76 (15.26)), p-value <0.001. Hip outcome score was higher in the arthroscopy group (mean (SD) 84.2 (17.4)) compared with the physiotherapy group (74.2 (21.9)), p-value < 0.001).Patients with FAI syndrome treated surgically may experience slowing of osteoarthritisprogression and superior pain and function compared with patients treated non- operatively.

Sustained immunological memory to SARS-CoV-2 antigens. Three years of observation

The COVID-19 pandemic has ended, but SARS-CoV-2 continues to actively circulate and mutate in the human population. In this regard, it is important to understand for how long post-infectious and post-vaccination immunity may last and how effectively established immunity could act against new mutant SARS-CoV-2 strains. The aim was to study humoral and cellular immunity in a group of COVID-19 convalescent subjects within 3 years after the primary infection. The longitudinal study included 38 adults aged 23–72 years with PCR-confirmed mild or moderate COVID-19 in the second half of 2020. Within three-year follow-up after the onset, the subjects were examined every 6 months for the level of humoral and cellular immunity against SARS-CoV-2 antigens. The parameters of humoral immunity were assessed by enzyme immunoassay using “SARS-CoV-2-IgG quantitative-ELISA-BEST” kits (Vector-Best JSC, Novosibirsk, Russian Federation) for S-protein and “N-CoV-2-IgG PS” (Saint-Petersburg Pasteur Institute, St. Petersburg, Russian Federation) specific to the N-protein. Cellular anti-SARS-CoV-2 immunity was analyzed by evaluating surface CD107a expression on CD8high lymphocytes stimulated with the SARS-CoV-2 S- or N-antigens. It was shown that the dynamics of antibody levels against SARS-COV-2 antigens depends on antigen (S- or N-protein) type, antibody class (IgG or IgA) as well as individual contact history with new SARS-CoV-2 strains. The dynamics of cytotoxic CD8highCD107a+ lymphocyte percentage is moderately positively correlated with that of the corresponding anti-S or N antibody levels. At the same time, change in the levels of both humoral and T-cell responses to SARS-CoV-2 S- or N-protein antigens are weakly negatively correlated with each other. A strong positive correlation was found between changes in the anti-S IgG antibody level and avidity. Avoiding the anti-S IgG neutralization due to frequent mutations of new SARS-CoV-2 strains leads to induced new primary immune responses against SARS-CoV-2 antigens along with the activation of existing responses formed to previous coronavirus strains. The study of immune responses against SARS-CoV-2 antigens allows to predict the persistence of high SARS-CoV-2 anti-S antibody and T-cell response levels.

Three-year follow-up analysis of automated microfoam preparation system for great saphenous vein incompetence and varicose veins sclerotherapy treatment.

To describe the treatment of patients with great saphenous vein (GSV) incompetence and varicose veins (VVs), utilizing an Automated Microfoam Preparation System (AMPS, Varixio®, VB Devices, Barcelona, Spain). Adults between January and June 2021 were included. The AMPS system was used for foam preparation. Sclerotherapy treatment followed international recommendations. The primary endpoint was GSV closure rate after 36 months. 164 patients were enrolled. During the 7-day follow-up period, all GSVs showed complete closure, which was maintained at the 1-year mark. No major complications were reported. A cumulative complete GSV recanalization rate of 6.1% and a partial recanalization rate of 26.8% after 36 months were noted. Some patients (9.7%) required additional treatment. A higher BMI was associated with complete recanalization. The AMPS offers an easy-to-use and standardized procedure, potentially enhancing treatment outcomes if compared with manual preparation. Caution is advised when treating obese patients.

Clinical and radiological outcomes of extracranial carotid artery stent placement: A single-center study

Objectives: Carotid artery stenting (CAS) and carotid endarterectomy are established treatments for carotid artery stenosis. We evaluated the early and mid- to late-term clinical and radiological outcomes of patients who underwent CAS. Materials and Methods: This retrospective study included 98 patients (112 arteries), who underwent CAS. Baseline demographics, stent types, embolic protection devices, and procedural complication rates within 30-day and 3-year post-CAS, including transient ischemic attack (TIA), stroke, death, and stent restenosis, were analyzed. Results: The 30-day complication rates included TIA (5.1%), ipsilateral stroke (4.1%), and death (4.1%). At three-year follow-up, TIA (8.5%), ipsilateral stroke (2.1%), restenosis (1.1%), and death (6.4%) were observed. Contralateral carotid artery angiography revealed neointimal hyperplasia in two vessels (1.9%) and 70–99% restenosis 1 (1%). Notably, a significant association was observed between neointimal hyperplasia and stent geometry, with a higher incidence observed in open-cell stents compared to closed-cell stents (P = 0.03). Conclusion: Our study demonstrated comparable early-term and lower mid- to late-term complication rates compared to prior studies. A multidisciplinary approach with meticulous technique, appropriate materials, and careful patient selection can optimize CAS outcomes.

Swept-source optical coherence tomography angiography findings in a case of primary vitreoretinal lymphoma over a three-year follow-up

BackgroundVitreoretinal lymphoma (VRL) still represents a diagnostic challenge for retinal specialists. Early diagnosis and treatment are critical for a better prognosis. Several diagnostic tools have proven helpful in the identification of VRL abnormalities. However, swept-source OCT angiography (SS-OCT-A) findings and their long-term follow-up are yet to be explored.Case presentationa 42-year-old man presented with blurred vision in his left eye for 2 weeks. He denied any systemic symptoms. A multimodal imaging examination was performed, raising the clinical suspicion of VRL and guiding the ensuing diagnostic procedures. The patient underwent treatment and at the last FU visit three years later, no disease signs were present on fundus examination, nor on oncologic evaluation. Some novel SS-OCT-A features were identified, and uncommonly reported findings were examined over a long-term follow-up. At baseline multiple hyperreflective alterations were detected on the enface outer retina slabs and choriocapillary analysis revealed low reflectance areas in the foveal and parafoveal areas. One month after the first presentation, multiple hyperreflective retinal lesions in a vertical shape were detected on OCT which appeared on midretinal slabs of enface SS-OCT-A as hyperreflective spots mainly located near second-order retinal vessels. These alterations remarkably reduced after treatment.ConclusionSS-OCT-A may be a useful imaging technique in the detection of VRL, providing ophthalmologists additional findings that assist the diagnosis and follow-up of this disease. This may prove useful for a more timely and precise diagnosis, prompt therapy, and treatment response monitoring. The original aspects found in this case may provide grounds for future studies, ultimately fostering a better understanding of the disease.

The Tibial Tuberosity-Trochlear Groove Distance Can either Increase or Decrease during Adolescent Growth.

Increased Tibial Tuberosity-Trochlear Groove (TT-TG) distance is a risk factor for recurrent lateral patella dislocations (RLPD). Population-based cross-sectional studies on healthy subjects demonstrate that the TT-TG increases gradually during growth until skeletal maturity, but changes in the TT-TG distance during adolescence in patients with RLPD on an individual basis have not been previously investigated. This study aimed to measure changes in TT-TG distance during skeletal maturity. The TT-TG of 13 consecutive patients with open physes (mean age 13 years) with RLPD was measured on MRI at baseline and three years later. The change in TT-TG distance over the three-year period was measured. The mean change in TT-TG distance from the baseline to the three-year follow-up increased overall (2.9 mm, 95% Confidence Interval (CI) 2.1-3.7). However, the TT-TG distance could either increase or decrease during final growth. Our results suggest that the TT-TG distance in patients suffering from RLPD may either decrease or increase individually during the growth spurt. This contradicts the current concept that the TT-TG distance increases gradually during growth.

Profile of adverse drug reactions reported via the Continuum+ platform: Results from three-year regional follow-up

In 2017, the Continuum+ platform was launched to provide a monitoring solution to home-based cancer care patients: AKO@dom monitoring. This platform also offers the follow-up of adverse drug reactions (ADRs) via direct notification to regional centers of pharmacovigilance (RCPVs). According to previous studies, the AKO@dom monitoring has successfully maintained treatment at the maximum effective dosage, managing ADRs and patient satisfaction. However, on the pharmacovigilance side, opinions are more divided. Due to the launch of the AKO@dom-PICTO experimentation in December 2021, in which our RCPV takes part, and to provide more data on pharmacovigilance, we decided to conduct a descriptive analysis of cases reported to our RCPV via the Continuum+ platform between 2019 and 2022. During these three years, we analyzed 1070 events, corresponding to 37patients. Patients were primarily women (74.8%) aged around seventy with breast cancer. The most used drugs were tyrosine kinase inhibitors: palbociclib (29.7%), axitinib (16.2%), and cabozantinib (13.2%). Patients had an average of 8 ADRs, including one serious and/or unexpected ADR. Although the Continuum+ platform makes it possible to considerably limit under-reporting in pharmacovigilance, it has shortcomings. The lack of medical elements and context in notifications is a massive problem for analyzing pharmacovigilance reports. Improved access to the platform's medical information for RCPVs and pharmacovigilance training for healthcare professionals would make Continuum+ a helpful tool in pharmacovigilance.

Three-year follow-up of a novel orthopedic ward fracture liaison services (OWFLS) model.

We established an orthopedic ward fracture liaison services (OWFLS) model and evaluated its role in improving detection rates of bone metabolic markers, treatment rates, and long-term treatability. This observational retrospective cohort study included 120 patients aged >50 years hospitalized for primary osteoporotic fracture from January 2018 to January 2019 (group A: not included in OWFLS). Group B (included in OWFLS) comprised 120 patients from February 2019 to February 2020. We compared rates of bone metabolic index testing, treatment, and adherence; symptomatic improvement; and recurrent fracture between groups. Rates of bone metabolism index testing (50% vs. 0%) and medication use (94.2% vs. 64.2%) were significantly higher after OWFLS implementation. There was no significant difference in adherence rates at 3 months between groups (97.3% vs. 93.5%). Adherence rates at 1 and 3 years were better in group B than A (73.5% vs. 51.9%; 57.5% vs. 26%, respectively). Recurrence of bone pain at 1 and 3 years was significantly lower in group B than A (20.4% vs. 46.8%; 45.1% vs. 76.6%, respectively). OWFLS improved the detection rate of bone metabolism indicators, treatment rate, and patient adherence and reduced recurrence of bone pain. OWFLS may be suitable for settings lacking human resources.

Aortopathy and aortic valve surgery in patients with bicuspid aortic valve with and without raphe

AimTo evaluate the association between raphe in bicuspid aortic valve (BAV) patients and valve dysfunction, aortopathy and aortic valve surgery in the REBECCA registry [REgistro della valvola aortica Bicuspide della Società Italiana di ECocardiografia e CArdiovascular Imaging (SIECVI)]. MethodsPrevalence of aortic valve dysfunction and aortopathy was investigated in BAV patients with and without raphe. Aortic valve dysfunction (regurgitation or stenosis) was categorized as mild, moderate and severe. Aortopathy was defined as annulus ≥14 mm/m2; root ≥20 mm/m2; sinotubular junction ≥16 mm/m2; ascending aorta ≥17 mm/m2, and classified in Type A, isolated ascending aorta dilatation; Type B, aortic root and ascending aorta dilatation; and Type C, isolated aortic root dilatation. ResultsOverall, 695 patients with BAV were enrolled; 520 (74.8%) with raphe and 175 (25.2%) without raphe. BAV patients with raphe presented more frequently with moderate or severe aortic stenosis than BAV patients without raphe (183 [35.2%] vs 34 [19.4%], p < 0.001). A higher prevalence of aortopathy, particularly Type B, was observed in patients with vs without raphe. At multivariable analysis, raphe was a predictor of aortic valve surgery at three-year follow-up (odds ratio 2.19, 95% confidence interval 1.08–4.44, p < 0.001). ConclusionsPatients with BAV and raphe have a higher prevalence of significant aortic stenosis, aortopathy, especially Type B, and a higher risk of undergoing aortic valve surgery at three-year follow-up.

Three-year follow-up analysis of the short-stitch versus long-stitch technique for elective midline abdominal closure randomized-controlled (ESTOIH) trial

BackgroundClinical trials have shown reduced incisional hernia rates 1 year after elective median laparotomy closure using a short-stitch technique. With hernia development continuing beyond the first postoperative year, we aimed to compare incisional hernias 3 years after midline closure using short or long stitches in patients from the ESTOIH trial.MethodsThe ESTOIH trial was a prospective, multicenter, parallel-group, double-blind, randomized-controlled study of primary elective midline closure. Patients were randomized to fascia closure using a short- or long-stitch technique with a poly-4-hydroxybutyrate-based suture. A predefined 3-year follow-up analysis was performed with the radiological imaging-verified incisional hernia rate as the primary endpoint.ResultsThe 3-year intention-to-treat follow-up cohort consisted of 414 patients (210 short-stitch and 204 long-stitch technique) for analysis. Compared with 1 year postoperatively, incisional hernias increased from 4.83% (20/414 patients) to 9.02% (36/399 patients, p = 0.0183). The difference between the treatment groups at 3 years (short vs. long stitches, 15/198 patients (7.58%) vs. 21/201 (10.45%)) was not significant (OR, 1.4233; 95% CI [0.7112–2.8485]; p = 0.31).ConclusionHernia rates increased significantly between one and 3 years postoperatively. The short-stitch technique using a poly-4-hydroxybutyrate-based suture is safe in the long term, while no significant advantage was found at 3 years postoperatively compared with the standard long-stitch technique.Trial registryNCT01965249, registered on 18 October 2013.

Exploring parenthood in first episode of psychosis: the potential role of the offspring in the outcome of women.

The study aimed to explore the role of parenthood at first episode of psychosis (FEP) on recovery, with a focus on potential sex differences. Sociodemographic, clinical, and neurocognitive information was considered on 610 FEP patients form the PAFIP cohort (Spain). Baseline and three-year follow-up comparisons were carried out. Chi-square tests and ANCOVA analysis were performed controlling for the effect of age and years of education. Men comprised 57.54% of the sample, with only 5.41% having offspring when compared to 36.29% of women. Parenthood was related to shorter duration of untreated illness (DUI) in women with children (12.08months mothers vs. 27.61months no mothers), showing mothers better premorbid adjustment as well. Childless men presented the worst premorbid adjustment and the highest cannabis and tobacco consumption rates. Mothers presented better global cognitive function, particularly in attention, motor dexterity and executive function at three-year follow-up. Diminished parental rates among FEP men could be suggested as a consequence of a younger age of illness onset. Sex roles in caregiving may explain the potential role of parenthood on premorbid phase, with a better and heathier profile, and a more favorable long-term outcome in women. These characteristics may be relevant when adjusting treatment specific needs in men and women with and without offspring.

Inflammatory blood cells and ratios at remission for psychosis relapse prediction: A three-year follow-up of a cohort of first episodes of schizophrenia

BackgroundThe clinical course following a first episode of schizophrenia (FES) is often characterized by recurrent relapses, resulting in unfavorable clinical and functional outcomes. Inflammatory dysregulation has been implicated in relapse risk; however, the predictive value of inflammatory blood cells in clinically remitted patients after a FES has not been previously explored. MethodsIn this study, we closely monitored 111 patients in remission after a FES until relapse or a three-year follow-up endpoint. The participants were recruited from the multicenter 2EPS Project. Data on inflammatory blood cells and ratios were collected at baseline and at the time of relapse or after three years of follow-up. ResultsMonocyte counts (OR = 1.91; 95 % CI = 1.07–3.18; p = 0.009) and basophil counts (OR = 1.09; 95 % CI = 1.01–1.12; p = 0.005) at baseline were associated with an increased risk of relapse, while the platelet-lymphocyte ratio (OR = 0.98; 95 % CI = 0.97–0.99; p = 0.019) was identified as a protective factor. However, after adjusting for cannabis and tobacco use during the follow-up, only monocyte counts (OR = 1.73; 95 % CI = 1.03–2.29; p = 0.027) and basophil counts (OR = 1.08; 95 % CI = 1.01–1.14; p = 0.008) remained statistically significant. ROC curve analysis indicated that the optimal cut-off values for discriminating relapsers were 0.52 × 10^9/L (AUC: 0.66) for monocytes and 0.025 × 10^9/L (AUC: 0.75) for basophils. When considering baseline inflammatory levels, no significant differences were observed in the inflammatory biomarkers at the endpoint between relapsers and non-relapsers. ConclusionThis study provides evidence that higher monocyte and basophil counts measured at remission after a FES are associated with an increased risk of relapse during a three-year follow-up period.

Three-year follow-up of rheumatoid meningitis with matrix metalloprotease-9 levels in the serum and cerebrospinal fluid as indicators of disease activity: A case report

Rheumatoid meningitis (RM) is an extra-articular complication of rheumatoid arthritis (RA). Although reports of RM sine arthritis exist, most patients with this presentation were diagnosed with RA within one year of RM onset. There are no established biomarkers reflecting the disease activity of RM. This case report highlights the elevation of matrix metalloprotease (MMP)-9 levels during the acute phase of RM and decline during remission. Additionally, this is the first case report of RA diagnosed three years after the onset of RM. It is important to further validate the utility of MMP-9 and conduct long-term follow-up of RM sine arthritis.

Percutaneous Image-Guided Cryoablation of Endophytic Renal Cell Carcinoma

PurposeEndophytic renal cancer treatment is a challenge. Due to difficulties in endophytic tumor visualization during surgical extirpation, image-guided percutaneous cryoablation (PCA) is an attractive alternative. The minimally invasive nature of PCA makes it favorable for comorbid patients as well as patients in which surgery is contraindicated. Oncological outcomes and complications after PCA of endophytic biopsy-proven renal cell carcinoma (RCC) were reviewed in this study.Materials and MethodsPatients were included after a multidisciplinary team conference from January 2015 to November 2021. Inclusion criteria were endophytic biopsy-proven T1 RCC treated with PCA with one year of follow-up. Complications were reported according to the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) classification system and the Clavien-Dindo classification (CDC) system. Major complications were defined as a grade ≥ 3 according to the CDC.ResultsFifty-six patients were included with a total of 56 endophytic tumors treated during 61 PCA sessions. The median RENAL nephrometry score was 9 (IQR 2), and the mean tumor size was 25.7 mm (SD ± 8.9 mm). Mean hospitalization time was 0.39 (SD ± 1.1) days. At a mean follow-up of 996 days (SD ± 559), 86% of tumors were recurrence free after one PCA. No patients progressed to metastatic disease. According to the CIRSE classification, 10.7% (n = 6) had grade 3 complications, and 5.4% (n = 3) had CDC major complications.ConclusionThis study demonstrates that PCA of endophytic biopsy-proven T1 RCC is safe with few major complications and excellent local tumor control rates at almost three-year mean follow-up.Level of Evidence 3Retrospective cohort study.Graphic

Prognostic factors for overall survival of conventional osteosarcoma of the appendicular skeleton.

The aim of this study is to determine the predictors of overall survival (OS) and predictive factors of poor prognosis of conventional high-grade osteosarcoma of the limbs in a single-centre in South Africa. We performed a retrospective cross-sectional analysis to identify the prognostic factors that predict the OS of patients with histologically confirmed high-grade conventional osteosarcoma of the limbs over ten years. We employed the Cox proportional regression model and the Kaplan-Meier method for statistical analysis. This study comprised 77 patients at a three-year minimum follow-up. The predictors of poor OS were: the median age of ≤ 19 years (hazard ratio (HR) 0.96; 95% confidence interval (CI) 0.92 to 0.99; p = 0.021); median duration of symptoms ≥ five months (HR 0.91; 95% CI 0.83 to 0.99; p < 0.037); metastasis at diagnosis (i.e. Enneking stage III) (HR 3.33; 95% CI 1.81 to 6.00; p < 0.001); increased alkaline phosphatase (HR 3.28; 95% CI 1.33 to 8.11; p < 0.010); palliative treatment (HR 7.27; 95% CI 2.69 to 19.70); p < 0.001); and amputation (HR 3.71; 95% CI 1.12 to 12.25; p < 0.032). In contrast, definitive surgery (HR 0.11; 95% CI 0.03 to 0.38; p < 0.001) and curative treatment (HR 0.18; 95% CI 0.10 to 0.33; p < 0.001) were a protective factor. The Kaplan-Meier median survival time was 24 months, with OS of 57.1% at the three years. The projected five-year event-free survival was 10.3% and OS of 29.8% (HR 0.76; 95% CI 0.52 to 1.12; p = 0.128). In this series of high-grade conventional osteosarcoma of the appendicular skeleton from South Africa, 58.4% (n = 45) had detectable metastases at presentation; hence, an impoverished OS of five years was 29.8%. Large-scale future research is needed to validate our results.

ANTI-VASCULAR ENDOTHELIAL GROWTH FACTOR TREATMENT IN DIABETIC MACULAR EDEMA: RESULTS FROM A LARGE SINGLE-CENTER COHORT WITH BEVACIZUMAB AS FIRST-LINE THERAPY.

To explore visual acuity (VA) outcomes of anti-vascular endothelial growth factor (VEGF) intravitreal injections in treatment-naive eyes with diabetic macular edema (DME), with bevacizumab as first-line treatment. Retrospective single-center cohort study over a three-year follow-up. Overall, 1765 eyes from 1179 patients treated with intravitreal injections were evaluated. The cohort was divided according to the treatment given: (1) bevacizumab monotherapy, (2) eyes switched to a second-line agent, and (3) eyes switched to a third-line agent. In total, 644 eyes of 444 patients met inclusion criteria. The mean age at presentation was 64.0 ± 11.1 years. The mean follow-up period was 24.6 ± 12.4 months. Furthermore, 67.1% of eyes were treated with bevacizumab monotherapy, 25.45% switched to a second-line agent, and 7.45% were switched to a third-line agent. The mean number of injections decreased significantly during each treatment year in the total cohort and within each treatment group ( P < 0.001). Mean VA for the total cohort and within each treatment group improved significantly throughout follow-up ( P < 0.001). No significant difference in VA was found between the groups ( P = 0.373). This real-world study demonstrates robust and consistent VA gains over long-term follow-up in eyes with DME treated with either bevacizumab monotherapy or switching to alternative anti-VEGF agents in cases of suboptimal response.

PPI use is not associated with bone microarchitecture and strength assessed with HR-pQCT after three-years follow-up in patients visiting the Fracture Liaison Service

BackgroundThe use of proton pump inhibitors (PPIs) has been associated with an increased fracture risk in observational studies. However, the reported association between PPI use and bone mineral density (BMD), bone microarchitecture, and bone strength is inconsistent. This study aims to assess the association between PPI use and bone microarchitecture and strength using high-resolution peripheral quantitative CT (HR-pQCT) in a three-year follow-up study in patients with a recent fracture visiting the Fracture Liaison Service (FLS). MethodsThis three-year prospective cohort study included FLS patients aged ≥ 50 years with a recent fracture (median age 62 [IQR 56–69] years, 68.7 % females) and without anti-osteoporosis treatment indication. HR-pQCT scans (distal radius and tibia) were obtained at baseline (T0) and three-year follow-up (T3). Volumetric bone mineral density and bone area, microarchitecture, and strength (micro-finite element analysis) were determined. The association between three-year continuous PPI use and the percentage change in HR-pQCT parameters between T0 and T3 was assessed using sex-stratified multivariate linear regression analyses. Covariates included age, BMI, vitamin-D deficiency (< 50 nmol/l), glucocorticoid use, and cardiovascular co-morbidity (males and females) fracture type (major/hip vs. all others, only males) and probable sarcopenia (only females). ResultsIn total, 282 participants had available medication data throughout follow-up, of whom 20.6 % were continuous PPI users. In both males and females with complete HR-pQCT follow-up data (males: N = 69 radius, N = 84 tibia; females: N = 147 radius, N = 168 tibia), PPI use was not associated with the percentage change of any of the bone microarchitecture or strength parameters between T0 and T3 at the radius and tibia as compared to non-use. ConclusionCompared to non-use, PPI use was not associated with the change of bone microarchitecture and strength in FLS patients at three years of follow-up. These results do not support that an altered bone microarchitecture or strength may contribute to the increased fracture risk associated with PPI use, as reported in observational studies.

Utility of superior augments in reverse shoulder arthroplasty (Exactech, Equinoxe GPS) without significant glenoid deformity

IntroductionSuperior augment use may help avoid superior tilt while minimizing removal of inferior glenoid bone. Therefore, our goal is to compare superior augments versus no augment baseplates in RSA for patients with rotator cuff dysfunction and no significant superior glenoid erosion. MethodsA multicenter retrospective analysis of 145 patients who underwent RSA with intraoperative navigation (Exactech, Equinoxe GPS) and three-year follow-up (mean 32-month follow-up, range 20 to 61 months) who had preoperative superior inclination less than 10 degrees and retroversion less than 15 degrees. Patient demographics, radiographic measurements, surgical characteristics, patient-reported outcomes at preoperative and postoperative visit closest to three years, and adverse events at final follow-up were obtained. Operative time, planned inclination, and planned version of the baseplate were obtained. Chi-square test used to compare categorical variables and student t-test used to compare augment and no augment cohorts. ResultsThe study population consisted of 54 superior augment patients and 91 no augment patients. The augment cohort had lower BMI (27.2 vs. 29.4, p-0.023), higher native superior inclination (5.9 vs. 1.4 degrees, p<0.001). No difference between the augment and no augment cohorts was found regarding age (p=0.643), gender (p=0.314), medical comorbidities (p>0.05), surgical indication (p=0.082), and native glenoid version (p=0.564). The augment cohort had higher internal rotation score (4.6 vs. 3.9, p=0.023), all remaining ROM and PROs preoperatively were not significantly different. At final follow-up, active ROM in all planes was not different between the cohorts. Regarding PROs, the postoperative SAS score was significantly higher (78.0 vs. 73.6, p=0.042), and ASES score trended towards higher (83.6 vs. 77.5, p=0.063) in the augment cohort. The augment cohort had significantly lower proportion of patients planned to have superior baseplate tilt (1.9% vs. 14.3%, p=0.012), and had greater mean inclination correction (6.3 vs. 1.3 degrees, p<0.001), compared to no augment cohort. Adverse events were rare, and there was no significant difference found between the augment and no augment cohorts (5.6% vs. 3.3%, p=0.509). DiscussionSuperior augmented baseplate in RSA with minimal superior glenoid erosion is associated with similar ROM and adverse events with somewhat improved postoperative PROs compared to non-augmented baseplates at 3-year follow-up. Additionally, superior augments resulted in a greater proportion of baseplates planned to avoid superior tilt, and trended toward shorter operative times. Further investigation of long-term glenoid baseplate loosening is imperative to fully understand the cost-effectiveness of superior augments in the setting of minimal glenoid deformity.

Factors Influencing Health-Related Quality of Life of Patients with Spinocerebellar Ataxia

BackgroundLittle is known about the progression of health-related quality of life (HRQoL) and predicting factors in spinocerebellar ataxia (SCA). Such knowledge is crucial to identify modifiable factors promoting everyday life with SCA and attenuating HRQoL decline.ObjectivesThis study is to assess HRQoL progression and identify factors affecting SCA patients’ HRQoL.MethodsLongitudinal data (three-year follow-up) of 310 SCA patients of the European SCA3/Machado-Joseph-Disease Initiative (ESMI) (2016-2022) and 525 SCA patients (SCA1, SCA2, SCA3 or SCA6) of the EUROSCA natural history study cohort (2006–2015) were assessed. Both large cohort studies share standardized assessments of clinical measures, SARA, INAS, PHQ-9, and HRQoL (EQ-5D-3L). The association between HRQoL and clinical measures was assessed by Spearman Correlation (rs). Multivariable panel regression models were performed to evaluate the impact of patients’ socio-demographics, age of onset, SCA type and body mass index (BMI), and clinical measures on HRQoL progression.ResultsHRQoL significantly decreased over one (− 0.014, p = 0.095), two (− 0.028, p = 0.003), and three years (− 0.032, p = 0.002). Ataxia severity and mental health strongly correlated with HRQoL (rsSARA = − 0.589; rsPHQ-9 = − 0.507). HRQoL more intensively declined in male (ß = − 0.024, p = 0.038) patients with an earlier age of onset (ß = 0.002, p = 0.058). Higher progression of ataxia severity (ß = − 0.010, p ≤ 0.001), mental health problems (ß = − 0.012, p < 0.001), and higher BMI (ß = − 0.003, p = 0.029) caused more severe decline of patients’ HRQoL over time.DiscussionIn absence of curative treatments, stronger focus on mental health and weight influence could help clinical evaluation and accompany treatment improving SCA patients’ HRQoL, especially in male patients with early disease onset.