Two-year Follow-up Period Research Articles

Basic lifestyle habits and volume change in total gray matter among community dwelling middle-aged and older Japanese adults

The brain controls human behavior, and the gray matter is the main resource of neuronal cells. We examined the longitudinal relationship between six basic lifestyle habits (diet, exercise, sleep, alcohol consumption, smoking, and social activity including employment) and total gray matter volume in community-dwelling adults in Japan.This two-year follow-up study with data derived from the National Institute for Longevity Sciences, Longitudinal Study of Aging, Aichi, Japan, included adults aged 40–87 years (n = 1665, men: 51%). Lifestyle habits were assessed at baseline (2008–2010) using self-reported questionnaires and three-day dietary records. Total gray matter volume at baseline and after two years was estimated using T1-weighted brain magnetic resonance imaging and FreeSurfer software. The association between each lifestyle factor, the total number of healthy lifestyle habits, and gray matter volume change was determined via a multiple linear regression analysis adjusting for baseline age, total gray matter volume, and other confounders. The mean ± standard deviation decrease in total gray matter volume during the two-year follow-up period was 0.94 ± 1.86% in men and 0.61 ± 2.27% in women. In the multiple regression analysis, volume loss in total gray matter positively correlated with male smoking, while it was negatively correlated with male social activity and employment, female dietary diversity, and the total number of healthy lifestyle habits (standardized beta coefficient; −0.061 in men [p = 0.07], −0.113 in women [p < 0.05]). Therefore, engaging in social activities, non-smoking, a diverse diet, or adopting one healthy lifestyle habit may help prevent gray matter volume loss.

High Serum FABP4 Levels are Negatively Associated with the Reversion from Prediabetes to Normal Glucose Tolerance: A 2-Year Retrospective Cohort Community Study.

ObjectiveTo explore the relationship between the level of fatty acid-binding protein 4 (FABP4) and reversion from prediabetes to normal glucose tolerance (NGT).MethodsA two-year retrospective cohort study was conducted on 398 participants with complete information. These 398 participants were divided into an NGT group and an abnormal glucose metabolism (AGM) group after 2 years of follow-up. The baseline level of FABP4 was determined, and the role of FABP4 in predicting reversion from prediabetes to NGT was investigated using an unconditional logistic regression model.ResultsOver the two-year follow-up period, 37.4% (149/398) of the participants reverted from prediabetes to NGT. The participants with AGM had a higher baseline level of FABP4 than those with NGT. The baseline level of FABP4 was significantly negatively correlated with reversion from prediabetes to NGT. After adjusting for age, sex, body mass index and waist-to-hip ratio, the level of fasting blood glucose (FBG) [odds ratio (OR) 0.336, 95% confidence interval (CI) (0.196–0.576)], 2-h post-challenge blood glucose (2hBG) [OR 0.697, 95% CI (0.581–0.837)], and FABP4 [OR 0.960, 95% CI (0.928–0.993)] at baseline were significant independent predictors of reversion from prediabetes to NGT. The area under the curve (AUC) value of the receiver operating characteristic curve for FABP4 was 0.605 (95% CI: 0.546–0.665), and the AUC for FABP4 combined with FBG and 2hBG was 0.716 (95% CI: 0.663–0.769).ConclusionA higher baseline level of FABP4 was positively correlated with an adverse profile of diabetes risk factors and negatively correlated with reversion from prediabetes to NGT. FABP4, FBG and 2hBG were predictors of reversion from prediabetes to NGT.

Effectiveness of crisis resolution home treatment for the management of acute psychiatric crises in Southern Switzerland: a natural experiment based on geography

BackgroundCrisis Resolution Home Treatment (CRHT) is an alternative to inpatient treatment for acute psychiatric crises management. However, evidence on CRHT effectiveness is still limited. In the Canton of Ticino (Southern Switzerland), in 2016 the regional public psychiatric hospital replaced one acute ward with a CRHT. The current study was designed within this evaluation setting to assess the effectiveness of CRHT compared to standard inpatient treatment.MethodsCRHT was offered to patients aged 18 to 65 with an acute psychiatric crisis that would have required hospitalization. We used a natural experiment based on geography, where intervention and control groups were formed according to the place of residence. Primary endpoints were reduction of psychiatric symptoms at discharge measured using the Health of the Nation Outcome Scales, treatment duration in days, and rate and length of readmissions during a two-year follow-up period after discharge. Safety during the treatment period was measured with the number of serious adverse events (suicide/suicide attempts, major self-harm episodes, acute alcohol/drug intoxications, aggressions to caregivers or family members). We used linear, log-linear and logistic regression models with propensity scores for the main analysis.ResultsWe enrolled 321 patients; 67 were excluded because the treatment period was too short and 17 because they were transferred before the end of the treatment. Two hundred thirty-seven patients were available for data analysis, 93 in the intervention group and 144 in the control group. No serious adverse event was observed during the treatment period in both groups. Reduction of psychiatric symptoms at discharge (p-value = 0.359), readmission rates (p-value = 0.563) and length of readmissions (p-value = 0.770) during the two-year follow-up period did not differ significantly between the two groups. Treatment duration was significantly higher in the treatment group (+ 29.6% on average, p-value = 0.002).ConclusionsCRHT was comparable to standard hospitalization in terms of psychiatric symptoms reduction, readmission rates and length of readmissions, but it was also characterized by a longer first treatment period. However, observational evidence following the study indicated that CRHT duration constantly lowered over time since its introduction in 2016 and became comparable to hospitalization, showing therefore to be an effective alternative also in terms of treatment length.Trial registrationISRCTN38472626 (17/11/2020, retrospectively registered).

The outcome of surgical mitral valve repair with loop-in-loop technique in dogs with different stage myxomatous mitral valve disease

ObjectivesSurgical mitral valve repair is a possible option for dogs with myxomatous mitral valve disease. However, information on surgical results and postoperative echocardiography is limited. This study aimed to verify the stage-specific surgical results of mitral valve repair and postoperative echocardiographic changes for two years following surgery. AnimalsAdult dogs (n = 55) treated with surgical mitral valve repair using the loop-in-loop technique were included in this study. Medical records were retrospectively reviewed. ResultsNinety percent of cases (50/55) survived to discharge, which survival was significantly decreased in myxomatous mitral valve disease advanced-stage dogs, Stage B2 (n = 14): 100%, Stage C (n = 27): 96.2%, and Stage D (n = 14): 71.4%. Significant reductions of overall heart size (vertebral heart score: preoperative 11.4 vs. post one month 10.2, P < 0.001), left atrium (left atrium to aortic root ratio: preoperative 2.3 vs. post one month 1.5, P < 0.001) and left ventricle (left ventricular end-diastolic diameter [normalized for bodyweight]: preoperative 2.2 vs. post one month 1.5, P < 0.001) were documented one month after surgery, showing successful management of mitral regurgitation. All medications for mitral valve disease were discontinued three months after surgery. The recurrence of mitral regurgitation was not evident during the two-year follow-up period. ConclusionsSurgical mitral valve repair with the loop-in-loop technique is associated with significant decreases in indices of cardiac size at one-month post-repair. Disease stage influences operative survival after surgical mitral valve repair.

Immunological consequences of cladribine treatment in multiple sclerosis: A real-world study

BackgroundCladribine is a synthetic deoxyadenosine analogue approved for the treatment of highly active relapsing multiple sclerosis (RMS). Cladribine is considered to be a semi-selective immune-reconstitution therapy (IRT) that induces long-term remission following short course of treatment. Here, we evaluated the effect of cladribine on immune cell reduction and reconstitution during the first two years of treatment. MethodsWe analyzed our longitudinal, prospective, real-world cohort of 80 cladribine-treated RMS patients from two tertiary centers in Germany. Laboratory testing was conducted monthly and included evaluation of cellular as well as soluble parameters. Laboratory outcomes were correlated with infectious adverse events (AEs) and clinical or paraclinical disease activity. ResultsSelective alterations in immune cell populations occurred following cladribine treatment, with the most marked effects observed in year two of treatment. Specifically, a rapid reduction in CD56+ natural killer cells (nadir: month 1 (year 1) and 14 (year 2); -37 and -41% from baseline) was followed by a greater reduction in CD19+ B cells (nadir: month 2 and 14; -81 and -82%); a moderate effect on CD4+ (nadir: month 3 and 15; -48 and -61%) and CD8+ T cells (nadir: month 5 and 18; -40 and -48%). Despite the marked effect on B cells, immunoglobulin levels were unaffected. There was no or minimal effect on thrombocytes and innate immune cells. Clinical and paraclinical disease activity was unrelated to the observed immune alterations. Lymphopenia was the most commonly observed AE (86.3% of patients; grade III-IV lymphopenia: 38.8%). The cumulative incidence of infections was 55% with cladribine treatment, which were mostly mild or moderate. In total, 19 herpes infections developed in 8 (10%) cladribine-treated patients; all cases were dermatomal and 94.7% of the herpetic infections occurred during a period of lymphopenia. ConclusionsThe immunophenotyping data obtained in our real-world setting are comparable to those demonstrated in pivotal clinical trials and provide further evidence that cladribine may represent a form of IRT. However, regarding the side-effect profile of cladribine, severe lymphopenia (exceeding grade II CTCAE) was more frequent, which may have prompted the development of herpes infections. Of note, lymphocyte dynamics did not correlate with clinical and paraclinical measures of disease activity in the two-year follow-up period.

A Comparison of Endoscopic Closure and Laparoscopic Repair for Gastric Wall Defection.

Objective To compare the effectiveness and safety of endoscopic closure and laparoscopic repair for gastric wall defection. Method The clinical data of 120 patients with submucosal tumours enrolled at our hospital between January 2014 and December 2019 were retrospectively analysed. Patients were divided into two groups according to the surgery they underwent: an endoscopic closure group (n = 60) and a laparoscopic repair group (n = 60). The clinical characteristics, perioperative complications, and postoperative follow-up results of the two groups were analysed. Results The surgery time in the endoscopic closure group was 56.20 ± 11.25 minutes, which was significantly lower compared with that in the laparoscopic repair group (159.35 ± 23.18 minutes; P < 0.001). In addition, the postoperative stay in the endoscopic closure group was shorter than that in the laparoscopic repair group, and the intraoperative bleeding volume and incidence of enteral nutrition initiation after surgery were significantly lower. Medical expenses were also significantly lower in the endoscopic closure group than in the laparoscopic repair group (P < 0.001). Only one patient developed a postoperative fever in the endoscopic closure group; three patients developed a postoperative fever and one patient had postoperative bleeding in the laparoscopic repair group. However, there were no statistical differences between the two groups regarding the incidence of R0 resection, postoperative fever, postoperative bleeding, and closure failure (all P > 0.05). There were no local recurrences, distant metastases, or deaths in either of the groups during the two-year follow-up period. Conclusion Non-laparoscopic-assisted surgery may be quicker, safer, and more effective for gastric wall defection.

Cyanoacrylate Adhesive Closure in the Real-World Practice: 2-Year Results of Varicose Vein Treatment

Introduction. Over the past decade, thermal tumescent (TT) ablation became the “gold standard” treatment of varicose veins. Non-thermal non-tumescent (NTNT) methods emerged in response to minimize the interventional invasion.Aim. To evaluate the two-year results of cyanoacrylate adhesive closure (CAC).Methods. Between July 2019 and July 2021, CAC was performed in 457 patients (average age 57.8 ± 15.7 years), on 634 limbs and 725 saphenous veins. Patient distribution according to CEAP was: C2 – 38%; C3 – 37%; C4 – 19%; C5 – 4%; C6 – 2%. The inclusion criteria were: incompetence of sapheno-femoral/popliteal junction and axial reflux &gt; 0.5 sec, diameter of saphenous trunk &gt; 6 mm, presence of varicosities. CAC was performed according to the protocol of the American Vein Closure System In more than 2/3 of cases (76.2%), CAC was performed selectively without tributary treatment . The pain was assessed by visual-analogue scale (VAS). The control ultrasound was performed on the 3rd day, 1, 3, 6, and 12 months post-intervention.Results. Anatomical success was achieved in 100%. The VAS pain score was &lt; 3 in 93% of patients. Partial recanalization occurred in 4 (0.6%) patients. Distal deep vein thrombosis was detected in 2 (0.3%) patients, migration of glue – in 7 (1%) patients, phlebitislike skin reaction – in 50 (11%), superficial thrombophlebitis – in 20 (4.4%) and soft tissue granuloma at the access site was diagnosed in 6 (1.3%) patients.Conclusion. CАC is a highly effective and safe treatment method with 99.4% occlusion rate in s. two-year follow-up period.

Prediction of the Short-Term Risk of New-Onset Renal Dysfunction in Patients with Type 2 Diabetes: A Longitudinal Observational Study.

Background Studies in the past decade have reported many novel biomarkers for predicting the new-onset or progression risk of renal dysfunction in patients with type 2 diabetes (T2D) based on the genomic, metabolomic, and proteomic technologies. These novel predictive markers, however, are difficult to be widely used in clinical practice over the short term due to their high technology content, instability, and high cost. This study was aimed at evaluating the associations of clinical features and six traditional renal markers with the short-term risk of new-onset renal dysfunction in patients with T2D. Methods This study involved 213 participants with T2D and normal renal function at baseline. The baseline levels of the albumin-to-creatinine ratio (ACR), estimated glomerular filtration rate (eGFR), alpha-1-microglobulin-to-creatinine ratio (A1MCR), neutrophil gelatinase-associated lipocalin-to-creatinine ratio, transferrin-to-creatinine ratio (UTRF/Cr), and retinol-binding protein-to-creatinine ratio (URBP/Cr) were analyzed. Multivariate logistic models were established and validated. Results During the two-year follow-up period, 23.01% participants progressed to renal dysfunction. The basal levels of ACR, A1MCR, UTRF/Cr, and URBP/Cr were the independent risk factors of new-onset renal dysfunction (P < 0.05). Several logistic models incorporating clinical characteristics and these renal markers were constructed for predicting the short-term risk of new-onset renal dysfunction. Comparatively, the model including age, glycated hemoglobin (HbA1c), hypertension, ACR, A1MCR, UTRF/Cr, and URBP/Cr levels at baseline had the highest potential (C − index = 0.785, P < 0.001). This model was validated using the K-fold cross-validation method; the accuracy was 0.815 ± 0.013 in training sets and 0.784 ± 0.019 in validation sets, indicating a good consistency for predicting the new-onset renal dysfunction risk. Finally, a nomogram based on this model was constructed to provide a quantitative tool to assess the individualized risk of short-term new-onset renal dysfunction. Conclusion The model incorporating these markers and clinical features may have a high potential to predict the short-term risk of new-onset renal dysfunction.

Physical multimorbidity predicts the onset and persistence of anxiety: A prospective analysis of the Irish Longitudinal Study on Ageing

BackgroundThe aims of the present study were to examine prospective associations of multimorbidity (i.e., ≥2 chronic conditions) at baseline with incident and persistent anxiety over a two-year follow-up period among Irish older adults, and to quantify the extent to which sleep, pain, and disability mediate the multimorbidity-anxiety relationship. MethodsData from The Irish Longitudinal Study on Aging (TILDA) conducted between 2009 and 2011 with a follow-up after two years were analyzed. Anxiety referred to score ≥ 8 on the anxiety section of the Hospital Anxiety and Depression Scale. Lifetime diagnosis of 14 chronic conditions was obtained. Outcomes were incident and persistent anxiety at two-year follow-up. ResultsData on 5871 adults aged ≥50 years at baseline were analyzed [Mean (SD) age 63.3 (9.0) years; 51.2% women]. After adjustment for potential confounders, compared to no chronic physical conditions at baseline, ≥3 chronic conditions were associated with a significant 1.89 (95% CI = 1.16–3.08) times higher risk for new onset anxiety at follow-up. Furthermore, having 1, 2, and ≥3 conditions at baseline were associated with significant 1.48 (95% CI 1.02, 2.14), 1.74 (95% CI 1.19, 2.53), and 1.84 (95% CI 1.27, 2.68) times higher risk for persistent anxiety at follow-up. Sleep problems, pain, and disability were identified as significant mediators, explaining 22.9%–37.8% of the associations. ConclusionMultimorbidity was associated with both new onset and persistent anxiety among Irish older adults. Future interventional studies should examine whether addressing the identified mediators may lead to lower risk for incident or persistent anxiety among those with physical multimorbidity.

Direct medical cost of bipolar disorder: Insights from the FACE-BD longitudinal cohort

BackgroundBipolar disorder (BD) is a severe chronic psychiatric disorder affecting 0.5 to 1% of the population worldwide. To date, most studies have estimated the cost of BD via information sourced from insurance claims with limited information on clinical characteristics and course of BD. The aims of this study are (i) to estimate the direct healthcare cost associated with BD and to identify contributing factors and (ii) to study the evolution of cost during a two-year follow-up period. MethodWe analyzed a sample of 1116 individuals with BD included in the Advanced Centers of Expertise in Bipolar Disorder cohort. We estimated the direct healthcare cost per year and per patient, and we identified the clinical features of patients with BD associated with higher direct healthcare costs. In a subsample of patients followed up for two years centers of expertise for BD, we studied the evolution of direct healthcare cost. ResultsThe average cost of bipolar disorder was € 6910 per year and per patient. Clinical features of BD, sociodemographic characteristics, and associated addiction were associated with higher direct healthcare costs. In the subsample of patients followed-up for two years, direct healthcare cost dropped by more than 50%, strongly suggesting the beneficial effect of specialized care organization. LimitationWe did not estimate indirect healthcare and intangible costs. ConclusionOur study investigates the cost of BD and its evolution in a deeply phenotyped longitudinal sample. Cost-utility and cost-effectiveness analyses are required to inform resource allocation decisions and to promote innovative healthcare organizations.

Study on the value of small dense low‐density lipoprotein in predicting cardiovascular and cerebrovascular events in the high‐risk stroke population

BackgroundLipid management in people at high risk of stroke is an important measurement to prevent the occurrence of stroke. The study aims to investigate the association between sdLDL and cardiovascular and cerebrovascular events in high‐risk stroke populations.MethodsThis was a prospective study. Screened from 15,933 individuals aged >40 years in April 2013 and followed up at 3rd, 6th, 12th, and 24th months, 823 participants met the screening criteria and were investigated for clinical data and biochemical parameters.ResultsA total of 286 subjects had varying degrees of carotid stenosis, and 18 subjects experienced cardiovascular and cerebrovascular events during the two‐year follow‐up period. There was no positive correlation between sdLDL and carotid stenosis. Carotid stenosis and extent of carotid stenosis involvement did not predict cardiovascular and cerebrovascular events in patients with high‐risk stroke, while sdLDL did. The sdLDL level in the events group was significantly higher than those in the no event group (p = 0.002). In the events group, the risk of events in the fourth quartile of sdLDL was 10.136 times higher than in the first quartile (HR = 10.136, 95% CI: 1.298–79.180, p = 0.027).ConclusionssdLDL was positively correlated with the incidence of cardiovascular and cerebrovascular events, which can predict the occurrence of an event and provide a scientific basis for early prevention.

Effects of a nursing home telehealth program on spending and utilization for Medicare residents.

To assess the effects of eLongTermCare (eLTC), a telehealth program implemented by an integrated health system in 45 nursing homes across the Midwest, on the use of acute hospital services and total expenditures for Medicare residents. Minimum Data Set, Medicare fee-for-service claims, and enrollment data from 2013 to 2018. We used a longitudinal difference-in-differences design to estimate the changes in outcomes for treatment beneficiaries before and after participating in the eLTC program, relative to changes for the matched comparison beneficiaries over the same period. We measured outcomes over a 24-month follow-up period, including total Medicare spending, emergency department (ED) visits, hospitalizations, and the likelihood of readmission. Using administrative data, we identified treatment beneficiaries who stayed at participating nursing facilities during the program period and matched comparison beneficiaries with similar baseline characteristics from non-participating facilities in the same geographic locations. For long-term care residents, the eLTC program led to an estimated reduction of 73 ED visits per 1000 beneficiaries (p < 0.01, 8.6% effect) over the two-year follow-up period. The estimated effects for this group were concentrated among beneficiaries who entered the nursing home after program startup, with sizable reductions in hospitalizations, ED visits, and spending. For skilled care residents, the program was associated with an estimated reduction of 85 ED visits per 1000 beneficiaries (p=0.03, 9.7% effect), but had no discernible effect on their hospitalizations or total Medicare spending. Telehealth can be a valuable tool for nursing homes to enhance care coordination and provide timely access to care, leading to lower spending for nursing home residents. Future research needs to explore payment methods that encourage telehealth expansion in nursing homes.

Abstract OT2-19-02: Clinical evaluation of the efficacy and liquid molecular analysis of abemaciclib rechallenge upon progression to abemaciclib combination therapies for ER-positive HER2-negative metastatic breast cancer patients

Abstract Background: Abemaciclib is a drug approved for ER-positive and HER2-negative metastatic or recurrent breast cancer and those treatable in an early setting. Some patients with ER-positive and HER2-negative breast cancer pretreated with abemaciclib and endocrine therapy may still benefit from abemaciclib rechallenge, especially in case of acquired resistance to endocrine therapy. However, there is no evidence for abemaciclib rechallenge. To address this, a single-arm phase 2 trial is planned to determine whether abemaciclib rechallenge has clinical benefits. Translational research to evaluate the gene alteration and immunohistochemistry will be conducted as an accompanying research to determine the predictive biomarkers of resistance or sensitivity to abemaciclib. Patients and Methods: The eligible patients are histologically confirmed with ER-positive and HER2-negative invasive breast cancer, locally advanced or metastatic, and previously received no more than two lines of endocrine therapy. The patients who previously received abemaciclib in combination with endocrine therapy led to a clinical benefit, including complete response, partial response, or stable disease, during abemaciclib-based treatment (≥6 months). The patients who previously received chemotherapy, immune checkpoint inhibitors (excluding perioperative systemic treatment), everolimus, olaparib, and palbociclib for advanced or metastatic diseases are excluded. The patients will be treated with abemaciclib 150 mg orally q12h on days 1 to 28 of a 28-day cycle. The other endocrine drug prescribed was not used in previous treatment. We will evaluate the gene mutations and/or amplification of ESR1, PIK3CA, CCNE1, FGFR1, RB1, TP53, NF1, MYC, AR, and MET at the time of inclusion and three months after day 1 and ctDNA and immunostaining levels of HER3, PTEN, CCNE1, FGFR1/2, and AR at the time of inclusion. The primary endpoint is progression-free survival (PFS), while the secondary endpoints are overall response rate, clinical benefit rate, chemotherapy-free interval, overall survival (OS), safety, and evaluation of the mechanism of sensitivity and resistance to abemaciclib. The expected median PFS for the study treatment arm is 5.0 months compared to the previous data of 3.0 months. The number of necessary cases is 59, with a significance level of 5% (two-sided) and power of 80% during the two-year recruitment period and one-year follow-up period. In the planned total of 65 cases, 10% is considered inappropriate. The planned duration of enrollment and follow-up is two years and one year, respectively. The planned total study duration is four years. Subgroup analysis will be performed on ESR1 and PIK3CA mutations, disease site (visceral/bone only/other), previous lines of therapy for advanced or metastatic disease (first and second), endocrine therapy for pretreatment (aromatase inhibitors/fuluvestrant), performance status (0/1), organs involved (1/2/≥3), age (&amp;lt;65/≥65 years), and disease-free interval (&amp;lt;36 months/≥36 months) to examine the interaction of treatment effects on PFS and OS. This study was funded by Eli Lilly and Company. Citation Format: Meiko Nishimura, Takahiro Kogawa, Yuko Akaishi, Misato Ogata, Jun Masuda, Mitsuo Terada, Hitomi Sakai, Kazuki Nozawa, Sasagu Kurozumi, Takamichi Yokoe, Yukinori Ozaki Ozaki, Shu Yazaki, Mai Onishi, Tsutomu Iwasa, Takuma Onoe, Yuta Okumura, Sayaka Nakayama, Kanako Hagio, Yuko Takahashi, Hirokazu Tanino, Junji Tsurutani, Koji Matsumoto, Mototsugu Shimokawa, Toshimi Takano. Clinical evaluation of the efficacy and liquid molecular analysis of abemaciclib rechallenge upon progression to abemaciclib combination therapies for ER-positive HER2-negative metastatic breast cancer patients [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr OT2-19-02.

Postoperative indications for further surgery following post-transvaginal ProliftTM mesh repair after a two-year follow-up period: a single-centre study

We investigated the frequency of further surgery post-artificial mesh (ProliftTM) repair of pelvic organ prolapse. In total, 257 patients who underwent ProliftTM repair were evaluated for further surgery frequency, clinical outcomes, and demographic characteristics. Thirty-eight (14.7%) patients underwent further surgery (median time to reoperation, 9.5 months; range, 6–22 months). Six (2.3%) patients underwent prolapse repair at a different (5 patients, 1.9%) or same site (1 patient, 0.3%). One underwent posterior ProliftTM repair; four, laparoscopic sacrocolpopexy; and one, vaginal hysterectomy. Eight (3.1%) underwent surgery for complications; seven (2.7%) required further surgery for mesh exposure (median, 8 months) and one (0.3%) required further surgery for mesh infection (1 month). Twenty-four (9.3%) received further surgery for stress urinary incontinence (median, 8.5 months). Despite the low frequency of further surgery post-ProliftTM repair, mesh-related complications should be considered. Careful long-term follow-up is necessary. Impact Statement What is already known on this subject? It is widely known that vaginal mesh is used as treatment for pelvic organ prolapse (POP). Vaginal mesh is one of the treatment options for POP. However, it received a bad reputation following reports of complications associated with its use, leading to discontinuation of vaginal mesh in many countries. What the results of this study revealed ? The findings of this study show that few patients who received ProliftTM repair required further surgery. The surgeries included surgery for non-POP-related conditions; subsequent surgery for stress urinary incontinence (SUI); surgery for complications including mesh exposure and infection; primary prolapse surgery for a different site and repeat surgery; and a repeat operation for prolapse arising from the same site. What are the implications of these findings in clinical practice and/or further research? Based on the outcome of this study, transvaginal ProliftTM mesh repair is a reasonably safe and effective treatment for POP. Despite withdrawal of all mesh products from the market as instructed by the FDA, this study suggested the need to re-evaluate the role of vaginal mesh as a treatment option for POP.

Long-term efficacy and safety of SARS-CoV-2 vaccination in patients with chronic kidney disease, on dialysis or after kidney transplantation: a national prospective observational cohort study

BackgroundCOVID-19 is associated with increased morbidity and mortality in patients with chronic kidney disease (CKD) stages G4-G5, on dialysis or after kidney transplantation (kidney replacement therapy, KRT). SARS-CoV-2 vaccine trials do not elucidate if SARS-CoV-2 vaccination is effective in these patients. Vaccination against other viruses is known to be less effective in kidney patients. Our objective is to assess the efficacy and safety of various types of SARS-CoV-2 vaccinations in patients with CKD stages G4-G5 or on KRT.MethodsIn this national prospective observational cohort study we will follow patients with CKD stages G4-G5 or on KRT (n = 12,000) after SARS-CoV-2 vaccination according to the Dutch vaccination program. Blood will be drawn for antibody response measurements at day 28 and month 6 after completion of vaccination. Patient characteristics and outcomes will be extracted from registration data and questionnaires during 2 years of follow-up. Results will be compared with a control group of non-vaccinated patients. The level of antibody response to vaccination will be assessed in subgroups to predict protection against COVID-19 breakthrough infection.ResultsThe primary endpoint is efficacy of SARS-CoV-2 vaccination determined as the incidence of COVID-19 after vaccination. Secondary endpoints are the antibody based immune response at 28 days after vaccination, the durability of this response at 6 months after vaccination, mortality and (serious) adverse events.ConclusionThis study will fulfil the lack of knowledge on efficacy and safety of SARS-CoV-2 vaccination in patients with CKD stages G4-G5 or on KRT.Trial registrationThe study protocol has been registered in clinicaltrials.gov(NCT04841785).Current knowledge about this subjectCOVID-19 has devastating impact on patients with CKD stages G4-G5, on dialysis or after kidney transplantation.Effective SARS-CoV-2 vaccination is very important in these vulnerable patient groups.Recent studies on vaccination in these patient groups are small short-term studies with surrogate endpoints.Contribution of this studyAssessment of incidence and course of COVID-19 after various types of SARS-CoV-2 vaccination during a two-year follow-up period in not only patients on dialysis or kidney transplant recipients, but also in patients with CKD stages G4-G5.Quantitative analysis of antibody response after SARS-CoV-2 vaccination and its relationship with incidence and course of COVID-19 in patients with CKD stages G4-G5, on dialysis or after kidney transplantation compared with a control group.Monitoring of (serious) adverse events and development of anti-HLA antibodies.Impact on practice or policyPublication of the study design contributes to harmonization of SARS-CoV-2 vaccine studymethodology in kidney patients at high-risk for severe COVID-19.Data on efficacy of SARS-CoV-2 vaccination in patients with CKD will provide guidance for future vaccination policy.

Economic evaluation of return-to-work interventions for mental disorder-related sickness absence: two years follow-up of a randomized clinical trial.

ObjectiveThe objective was to (i) assess the long-term cost-effectiveness of acceptance and commitment therapy (ACT), a workplace dialog intervention (WDI), and ACT+WDI compared to treatment as usual (TAU) for common mental disorders and (ii) investigate any differences in cost-effectiveness between diagnostic groups.MethodsAn economic evaluation from the healthcare and limited welfare perspectives was conducted alongside a randomized clinical trial with a two-year follow-up period. Persons with common mental disorders receiving sickness benefits were invited to the trial. We used registry data for cost analysis alongside participant data collected during the trial and the reduction in sickness absence days as treatment effect. A total of 264 participants with a diagnosis of depression, anxiety, or stress-induced exhaustion disorder participated in a two-year follow-up of a four-arm trial: ACT (N=74), WDI (N=60), ACT+WDI (N=70), and TAU (N=60).ResultsFor all patients in general, there were no statistically significant differences between interventions in terms of costs or effect. The subgroup analyses suggested that from a healthcare perspective, ACT was a cost-effective option for depression or anxiety disorders and ACT+WDI for stress-induced exhaustion disorder. With a two-year time horizon, the probability of WDI to be cost-saving in terms of sickness benefits costs was 80% compared with TAU.ConclusionsACT had a high probability of cost-effectiveness from a healthcare perspective for employees on sick leave due to depression or anxiety disorders. For participants with stress-induced exhaustion disorder, adding WDI to ACT seems to reduce healthcare costs, while WDI as a stand-alone intervention seems to reduce welfare costs.

Importance of the creation of a short musculofascial tunnel in peritoneal dialysis catheter placement.

BACKGROUNDPeritoneal dialysis (PD) catheter migration impedes the efficacy of dialysis. Therefore, several techniques involving additional sutures or incisions have been proposed to maintain catheter position in the pelvis.AIMTo evaluate the efficacy of creating a short musculofascial tunnel beneath the anterior sheath of the rectus abdominis during PD catheter implantation.METHODSPatients who underwent PD catheter implantation between 2015 and 2019 were included in this retrospective study. The patients were divided into two groups based on the procedure performed: Patients who underwent catheter implantation without a musculofascial tunnel before 2017 and those who underwent the procedure with a tunnel after 2017. We recorded patient characteristics and catheter complications over a two-year follow-up period. In addition, postoperative plain abdominal radiographs were reviewed to determine the catheter angle in the event of migration.RESULTSThe no-tunnel and tunnel groups included 115 and 107 patients, respectively. Compared to the no-tunnel group, the tunnel group showed lesser catheter angle deviation toward the pelvis (15.51 ± 11.30 vs 25.00 ± 23.08, P = 0.0002) immediately after the operation, and a smaller range of migration within 2 years postoperatively (13.48 ± 10.71 vs 44.34 ± 41.29, P < 0.0001). Four events of catheter dysfunction due to migration were observed in the no-tunnel group, and none occurred in the tunnel group. There was no difference in the two-year catheter function survival rate between the two groups (88.90% vs 84.79%, P = 0.3799).CONCLUSIONThe musculofascial tunnel helps maintain catheter position in the pelvis and reduces migration, thus preventing catheter dysfunction.

The Risk Factors of Severe Hypoglycemia in Older Patients with Dementia and Type 2 Diabetes Mellitus.

Background: The adequate glycemic control and risk factors for hypoglycemia in older patients with dementia and type 2 diabetes mellitus (T2DM) remain unclear. This study aimed to analyze the status of glycemic control and determine the risk of hypoglycemia among these groups. Methods: A hospital admission record due to hypoglycemia through an emergency room with glucose supplementation in the Chang Gung Memorial Hospital was identified as a hypoglycemic event. Patients with dementia and T2DM without hypoglycemic events throughout the study period were defined as the control group. We gathered patients aged ≥65 years with a diagnosis of Alzheimer’s dementia (AD) and T2DM between 2001 and 2018 in the Chang Gung Research Database (CGRD). We extracted data included medication use, diagnoses, and biochemistry data from hospital records. Results: A total of 3877 older patients with dementia and T2DM with regular visits to the outpatient department were enrolled in this study. During the two-year follow-up period, 494 participants (12.7%) experienced hypoglycemia. Multivariable logistic multivariable regression models for hypoglycemic events showed that metformin had a protective effect (odds ratio (OR) = 0.75, p = 0.023), insulin had the highest risk (OR = 4.64, p < 0.001). Hemoglobin A1c (HbA1c) levels were not correlated with hypoglycemic events (OR = 0.95, p = 0.140). Patients with hypoglycemic episodes had a significantly higher proportion of ≥2 Charlson Comorbidity Index scores than those without hypoglycemic episodes (83.2% versus 56.4%, p < 0.001). Conclusions: Drug regimen affects hypoglycemic episodes but not HbA1c in older patients with dementia and T2DM. In addition, patients with more comorbidities experience an increased risk of hypoglycemia.

Ectopic thyroid nodes in the mediastinum - report of two cases

Introduction. Ectopic thyroid is a rare anomaly characterized by presence of thyroid tissue outside its normal location, which could be the consequence of developmental abnormality, sequestration of thyroid nodes from nodal thyroid goiter or mechanical implantation of thyroid tissue after resection or trauma. Ectopic thyroid is commonly incidentally detected and causes differential diagnostic dilemma towards the neck and mediastinal tumors. The object of this report was to present two types of ectopic thyroid nodes located in the upper mediastinum, incidentally discovered by computed tomography (CT). Outline of cases. A hyperdense nodular lesion was found in the anterior upper mediastinum in a 42-yearold woman with adenocarcinoma of the esophagogastric junction in whom CT was performed due to staging purposes. Metastatic left supraclavicular lymph node was considered in the differential diagnosis. However, as the node was located in front of the neck fascia and just below the thyroid gland and showed similar density to thyroid tissue, the diagnosis of accessory thyroid gland was made, which was later confirmed by multiple repeated CT scans during the two-year follow-up period. In a 52-year-old woman presenting with intermittent chest pain and cough, contrast-enhanced CT scan revealed nodal thyroid goiter and three nodes of similar CT texture, located in the upper mediastinum, below the thyroid gland. Accordingly, the diagnosis of parasitic mediastinal goiter thyroid nodes was made. Conclusion. Ectopic thyroid nodes are presented by CT as well-circumscribed nodes of the same density as the thyroid gland, typically located anteriorly in the upper mediastinum.

A Clinical Case of Two-Stage Visual-Functional Rehabilitation of a Patient with Postinfectious Central Corneal Opacity in Combination with Mixed Astigmatism Using Laser Keratorefractive Surgery

Introduction: to evaluate the clinical and functional results of two-stage treatment in a patient with post-infectious Central corneal opacity combined with mixed astigmatism.Patient and methods. Patient N., 19 years old with postinfectious (postherpetic) Central corneal opacity, mixed astigmatism was examined and operated using two-stage corneal laser treatment. To determine the possibility of surgical treatment of the patient, a complex of General ophthalmology was performed (checking visual acuity near and far in natural conditions and in conditions of drug-induced mydriasis, IOP measurement, autorefractometry, examination of visual fields, A- and Bscanning, ophthalmoscopy with examination of the Central and peripheral areas of the fundus), as well as special (keratopography and Scheimpflug camera examination, optical coherence tomography (OCT) of the anterior segment of the eye with analysis of the epithelial map, quantitative assessment (Schirmer test-1) and qualitative (tear film rupture time) lachrymal products, assessment of the epithelium state when stained with vital dyes and infrared meibography) research methods. To determine the activity of herpetic infection, PCR diagnostics were performed. The follow-up period was 2 years.Results and discussion. To achieve high visual-functional rehabilitation while preserving the native lens, a two-stage treatment algorithm was developed using technologies of laser corneal refractive surgery. At the first stage, in order to regularize the ocular surface and eliminate Central corneal opacity, an inverted topographically oriented PRK was performed; at the second stage, residual refractive errors were corrected using topographically oriented FemtoLASIK technology.Conclusion. According to the results of a literature search and analysis of Internet resources, there were no previously recorded and published works using a similar two-stage method. Therefore, the described clinical case justifies the relevance and novelty of the goal and has an evidence-based Foundation for the use of a two-stage laser keratorefractive treatment system in the ophthalmological practice of visual and functional rehabilitation of patients with Central corneal opacity in combination with mixed astigmatism or hypermetropic refraction. The two-year postoperative follow-up period showed stable and high visual-functional results with no recurrence of the inflammatory process.