Retrospective Clinical Cohort Study Research Articles

Transferrin saturation is a superior prognostic biomarker for iron deficiency after acute decompensated heart failure: a retrospective clinical real-world cohort study

Abstract Background Iron deficiency (ID) is the most common extracardiac comorbidity in heart failure (HF) and associated with worse outcomes. While a uniform definition of ID in HF remains lacking, several biomarkers for ID, including ferritin and transferrin saturation (TSAT), are used in both clinical trials and clinical practice. However, which biomarker is a superior prognostic predictor for ID in HF remains unsettled. In addition, real-world clinical data on ID screening and intravenous (IV) iron treatment is largely missing. Purpose To determine which biomarker is a superior prognostic predictor for the composite endpoint of HF rehospitalisation (HHF) and all-cause mortality in a real-world cohort of patients with HF and coexisting ID, and to investigate frequency and predictors of ID screening and IV iron treatment. Methods In this retrospective cohort study, all patients aged 18-85 years hospitalised at a tertiary university hospital with new onset HF with reduced ejection fraction (HFrEF) in 2016-2020 were consecutively included from medical records by ICD-10 code I50.0-I50.9 and followed until 31 December 2021. Patient characteristics, comorbidities, medications, laboratory results and data on follow-up, including if ID was tested for, IV iron administration, HHF and all-cause mortality was collected. First available iron status after admission for index hospitalisation was used. Predictors for ID screening and IV iron use were identified with univariate logistic regression. The association between ID markers and the composite endpoint was analysed with Cox regression adjusted for age, sex, baseline anemia, estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 and N-terminal pro-B type natriuretic peptide (NT-proBNP) below median value with median ferritin and TSAT values set as references respectively. Results In all, 753 patients were included (66.5 ± 12.7 years, 508 (67.5%) men, ejection fraction 29.5 ± 6.9% and mean NT-proBNP 6241 ± 7183 ng/L). Of these, 484 (64.3%) were screened for ID and 235 (48.6%) fulfilled criteria for ID. Of these, 94 (40.0%) received IV iron. Of screened patients, 28.6% had ID with anemia and 20.8% ID without anemia (Table 1). Factors associated with screening for ID were follow-up at hospital, anemia, eGFR <30 mL/min/1.73 m2 and ischemic heart disease, and for IV iron additionally chronic kidney disease and peripheral artery disease. Median ferritin was 140 µg/L and TSAT 0.2. Both ferritin and TSAT displayed an inversely linear association with outcomes, while TSAT <0.2 showed a stronger association with increased risk of HHF and all-cause mortality compared to median values (Figure 1-2). Conclusions In a real-world clinical setting, TSAT was a superior prognostic biomarker for worse outcomes compared to ferritin in patients hospitalised for acute HF. While both ID screening and IV iron use remained greatly underutilised in clinical practice, identification of a reliable biomarker for ID is critical.

Stabilization of 82 sacroiliac luxations in 67 cats using two sacroiliac screws (2014-2023).

To describe sacroiliac luxation stabilization in cats using two screws and to report clinical and radiographic short-term outcomes. Retrospective clinical cohort study. Cats (n = 67) with sacroiliac luxation. Case records of cats presented for sacroiliac luxation stabilized using two screws per side affected, one lag and one positional, between 2014 and 2023 were reviewed. The percentage of sacral purchase (PoSP) for each screw, percentage of reduction (PoR), and pelvic canal width ratio (PCWR) were measured and calculated. Eighty-two sacroiliac luxations were stabilized. Two 2.0 mm screws were used in 69 cases; two 2.4-mm screws in nine cases, and one 2.4 mm with one 2.0 mm screw in four cases. The mean PoSPs for lag and positional screws were 46% ± 12 and 31% ± 11, respectively. The median PoR was 89% (41 to 100). The mean PCWR was 1.23 ± 0.11. Clinical follow up was available for 42 cats with 53 sacroiliac luxations at a median of 87 days (36 to 2503). The full function was noted in 34 patients (81%). Screw failure occurred in five sacroiliac joints (4.7%), including loosening (n = 3), and breakage (n = 2) of the positional screws (n = 1). Pelvic canal diameter was maintained in all cases. Excellent functional and radiographic outcomes were obtained for cats with sacroiliac luxation stabilized with two sacroiliac screws. Feline sacroiliac luxation can be stabilized using two sacroiliac screws.

Association between kidney function, frailty and receipt of invasive management after acute coronary syndrome

BackgroundReduced estimated glomerular filtration rate (eGFR) is associated with lower use of invasive management and increased mortality after acute coronary syndrome (ACS). The reasons for this are unclear.MethodsA retrospective clinical...

Submacular Hemorrhage Rates Following Anti-Vascular Endothelial Growth Factor Injections for Exudative Age-Related Macular Degeneration

Objective: To examine rates of submacular hemorrhage in patients undergoing anti-VEGF injections, comparing rates between specific anti-VEGF agents. Design: Retrospective clinical cohort study. Participants: All patients in the database from January 2015-November 2023 with a diagnosis of neovascular age-related macular degeneration (nAMD) and accompanying submacular hemorrhage (SMH). Methods: SMH prevalence and associated anti-VEGF injection type were analyzed in 140,915 eyes (of which 9,107 had SMH) in a nationwide aggregated electronic health care database using chi-square test of proportion. Visual acuity (VA) data was assessed using 2-sample independent t-tests. The primary outcome was rate of SMH per injection type. Secondary datapoints examined were time between SMH diagnosis and last anti-VEGF injection, number of injections before SMH, treatment interval at time of SMH, VA before and at 12 months after SMH, eyes undergoing pars plana vitrectomy (PPV) within 30 days of SMH, and VA before PPV and at 12 months after PPV. Results: The last injection type in eyes with SMH was bevacizumab in 3,439 (37.8%) eyes, brolucizumab-dbII in 46 (0.51%) eyes, aflibercept in 3,221 (35.4%) eyes, ranibizumab in 2,246 (24.7%) eyes, and faricimab-svoa in 155 (1.7%) eyes. Rates of SMH were significantly higher (p≤0.001) for last injection with bevacizumab compared to every other injection type. Rates of SMH were significantly lower (p=0.0004) for last injection with faricimab-svoa compared to every other injection type. Patients receiving either faricimab-svoa or ranibizumab injections each had significantly shorter (mean and standard deviation (SD) 48.9 (27.9), p<0.02; mean and standard deviation (SD) 59.6 (38.2), p=0.003, respectively) mean time between SMH diagnosis and last injection than did patients undergoing any other injection. Mean VA before SMH and at 12 months after SMH did not significantly differ by injection type among all patients. The number of patients who underwent PPV were 52 (1.51%) for bevacizumab, 4 (8.7%) for brolucizumab-dbII, 58 (1.8%) for aflibercept, 41 (1.8%) for ranibizumab, and 3 (1.9%) for faricimab-svoa. Mean VA before SMH and at 12 months after SMH did not significantly differ by injection type in patients undergoing PPV. Conclusions: Faricimab may be more protective than other anti-VEGF injections against SMH in patients with nAMD.

Risk of Healing Complications Following Alveolar Process Fractures in the Primary Dentition: A Retrospective Clinical Cohort Study.

Alveolar bone process fractures in preschool children are not well documented in the literature. Alveolar process fractures are located very close to primary teeth and permanent tooth germs. This study investigates the risk of healing complications following alveolar process fractures in the primary dentition and potential sequelae in the permanent dentition. A retrospective cohort study was conducted involving 21 patients with 49 primary teeth involved in an alveolar fracture. The follow-up protocol included clinical and radiographic examinations at specified intervals up to the age of 6 years. Healing complications in the primary teeth such as pulp necrosis, pulp canal obliteration, ankylosis, infection-related resorption and premature tooth loss were examined. Sequelae in the permanent dentition was also registered when the permanent incisors had erupted. Over a 3-year follow-up, the incidence of premature tooth loss was 51.2% [95% CI: 34.1%-68.4%], pulp canal obliteration was 42.5% [95% CI: 27.1%-57.8%], and pulp necrosis was 8.9% [95% CI: 0.6%-17.3%] following an alveolar process fracture. No cases of ankylosis were observed. Sequelae in the permanent dentition primarily included demarcated opacities and hypoplasia with a risk estimated at 24% [95% CI: 13%-39%] and 9% [95% CI: 2%-21%] respectively. Alveolar process fractures in primary dentition are associated with several healing complications in the primary teeth. Although the likelihood of severe complications in the permanent dentition is low, young children are still susceptible to developing sequelae in their permanent teeth. These results highlight the importance of awareness of dental injuries following alveolar process bone fractures in the primary dentition.

Association Between Glucagon-Like Peptide-1 Receptor Agonists Exposure and Intraocular Pressure Change: GLP-1 Receptor Agonists and Intraocular Pressure Change

This study evaluates the effects of glucagon-like peptide-1 receptor (GLP-1R) agonists on intraocular pressure (IOP). Retrospective clinical cohort study. The University of California Health Data Warehouse was queried for patients exposed to GLP-1R agonists or other oral antidiabetics. A total of 1247 glaucoma surgery and treatment naïve eyes of 626 patientson GLP-1R agonists and 1083 glaucoma surgery and treatment naïve eyes of 547 patients on other oral antidiabetics were included. Index date was defined as the date of first exposure to the medication. Eyes with at least one pre-exposure and one post-exposure tonometry records within 365 days of the index date were included. Clinical and laboratory data were extracted. Eyes were excluded upon exposure to glaucoma hypotensive medication or glaucoma surgery. The primary outcome measure was ∆IOP after exposure, which was analyzed using a paired t test and generalized estimating equations (GEE) RESULTS: The median age was 66.2 years [IQR = 18.3]; 607 (51.7%) were female, and 667 (56.9%) were Caucasian. Median pre-exposure IOP, hemoglobin A1c, and body mass index were 15.2 mm Hg [IQR = 3.8], 7.5 [IQR = 2.4], and 29.8 [IQR = 9.4], respectively. A total of 776 individuals (66.1%) had diabetes, with the median number of active oral antidiabetics being 1.0 [IQR = 1.0], and 441 (37.5%) being insulin users. Several pre-exposure characteristics differed between the groups. The mean ∆IOP was -0.4 ± 2.8 mm Hg (paired t test P < .001) and -0.2 ± 3.3 mm Hg (paired t test P = .297) in the GLP-1R agonist and other antidiabetics groups, respectively. Pre-exposure IOP was the only independent predictor of ΔIOP in multivariable GEE. Sensitivity analyses yielded similar results. Although GLP-1R agonists were significantly associated with a decrease in IOP in the paired analysis, they were not associated with ΔIOP in multivariable GEE. Moreover, the difference in ΔIOP between the two groups was small.

Positive Airway Pressure, Mortality, and Cardiovascular Risk in Older Adults With Sleep Apnea

Positive airway pressure (PAP) is the first-line treatment for obstructive sleep apnea (OSA), but evidence on its beneficial effect on major adverse cardiovascular events (MACE) and mortality prevention is limited. To determine whether PAP initiation and utilization are associated with lower mortality and incidence of MACE among older adults with OSA living in the central US. This retrospective clinical cohort study included Medicare beneficiaries with 2 or more distinct OSA claims identified from multistate, statewide, multiyear (2011-2020) Medicare fee-for-service claims data. Individuals were followed up until death or censoring on December 31, 2020. Analyses were performed between December 2021 and December 2023. Evidence of PAP initiation and utilization based on PAP claims after OSA diagnosis. All-cause mortality and MACE, defined as a composite of myocardial infarction, heart failure, stroke, or coronary revascularization. Doubly robust Cox proportional hazards models with inverse probability of treatment weights were used to estimate treatment effect sizes controlling for sociodemographic and clinical factors. Among 888 835 beneficiaries with OSA included in the analyses (median [IQR] age, 73 [69-78] years; 390 598 women [43.9%]; 8115 Asian [0.9%], 47 122 Black [5.3%], and 760 324 White [85.5%] participants; median [IQR] follow-up, 3.1 [1.5-5.1] years), those with evidence of PAP initiation (290 015 [32.6%]) had significantly lower all-cause mortality (hazard ratio [HR], 0.53; 95% CI, 0.52-0.54) and MACE incidence risk (HR, 0.90; 95% CI, 0.89-0.91). Higher quartiles (Q) of annual PAP claims were progressively associated with lower mortality (Q2 HR, 0.84; 95% CI, 0.81-0.87; Q3 HR, 0.76; 95% CI, 0.74-0.79; Q4 HR, 0.74; 95% CI, 0.72-0.77) and MACE incidence risk (Q2 HR, 0.92; 95% CI, 0.89-0.95; Q3 HR, 0.89; 95% CI, 0.86-0.91; Q4 HR, 0.87; 95% CI, 0.85-0.90). In this cohort study of Medicare beneficiaries with OSA, PAP utilization was associated with lower all-cause mortality and MACE incidence. Results might inform trials assessing the importance of OSA therapy toward minimizing cardiovascular risk and mortality in older adults.

Hepatic artery restriction operation combined with ALPPS (HARO-ALPPS), a novel ALPPS procedure for the treatment of hepatocellular carcinoma with severe fibrosis: retrospective clinical cohort study.

Associating liver partition with portal vein ligation for staged liver resection (ALPPS) has been used in the treatment of patients with advanced or massive liver cancer without sufficient future liver remnant, but concerns remain regarding tumor outcomes and surgical safety. This study aims to evaluate the efficacy and safety of a new procedure, hepatic artery restriction operation combined with ALPPS (HARO-ALPPS), in the treatment of hepatocellular carcinoma (HCC) patients especially with severe fibrosis. This retrospective study analyzed 8 patients who underwent HARO-ALPPS for HCC and compared their outcomes with 64 patients who underwent conventional ALPPS. The primary outcomes assessed were liver regeneration ability (measured by relative and absolute kinetic growth rates), postoperative complications, and mortality. The secondary outcomes included overall survival and disease-free survival. HARO-ALPPS significantly restricted the blood supply of the hepatic artery. One week after surgery, the blood flow of the right hepatic artery dropped to 62.1%. At the same time, HARO-ALPPS shows superior liver regeneration ability, which is particularly prominent in the background of liver fibrosis. No serious complications occurred after HARO-ALPPS. The overall survival rate of HARO-ALPPS was 75%, which was higher than that of ALPPS (64%, P =0.816). Compared to conventional ALPPS, HARO-ALPPS exhibits a better liver regeneration ability, and favorable long-term outcomes. Further prospective studies are needed to validate these findings and evaluate the long-term oncologic outcomes of this novel procedure.

Survival Rate, Biomechanical Complications, and Patient Satisfaction of Implant-Supported FRC Full-Arch Prostheses: A Retrospective Study with Follow up of 5 Years.

The satisfaction of patients with dentures on implants has different points of view that become fundamental aspects for the development of research on the quality of life of these patients, the eventual biomechanical complications to which these prostheses and implants can be subjected, and design considerations for cantilever extensions. The objective of research was to assess the implants and prosthesis survival rates, biomechanical complications relative to the length of the distal extensions (cantilevers), and the satisfaction of the patients with a fixed implant-supported full-arch fiber-reinforced composites prosthesis. A retrospective clinical and radiographic cohort study was developed. Clinical records of a selected cohort were analyzed according to inclusion and exclusion criteria. Data on a patient who underwent to fixed implant-supported full-arch fiber-reinforced composites prosthesis at least of five years of function were collected. Data analysis was performed using Kaplan-Meier curves and Fisher's Exact Test. P values less than 0.05 were considered statistically significant. After insertion, 1 of 29 prostheses failed, the overall prosthetic survival rate observed at 5 years was 96.5%. Of the 120 implants placed in 28 patients, only 4 patients experienced loss of an implant during the 5 years of observation; the implant survival rate throughout the observation period was 86.2%. Distal extension seems to negatively affect the prognosis of implant-supported rehabilitation. Regarding the level of satisfaction of the patient with the prosthesis, none reported being uncomfortable or dissatisfied neither with their appearance nor with the taste of food throughout the studied period. No relevant associations were found between the variables involved. The study found the improvement in quality of life following the installation of fixed rehabilitation on the patients. Once the potential benefits of patients are obtained, controlled clinical trials are encouraged.

Different meanings of a three-point decline in MMSE score in Alzheimer's disease and depressive disorder.

The Mini-Mental State Examination (MMSE) is a composite scale that is included in diagnostic algorithms and in procedures to assess severity of cognitive impairment and efficacy of therapeutic interventions. It is unclear, however, whether the MMSE provides information about the same deficits in different diseases. To assess patterns of MMSE scores in patients with confirmed diagnosis of Alzheimer's disease or depressive disorder. We used data from a previously published cross-sectional retrospective observational clinical cohort study. The final analysis included only patients in whom biomarker analysis showed results characteristic of Alzheimer's disease (n = 167) and patients with depressive disorder in whom Alzheimer's disease had been ruled out by analysis of biomarkers (n = 69). A three-point decline in MMSE score from 30 to 27 reflected impairment of memory recall in patients with Alzheimer's disease, whereas it reflected impairments in calculation and memory recall in patients with depressive disorder. A further three-point decline in MMSE score from 27 to 24 predominantly reflected additional calculation impairment in patients with Alzheimer's disease. Our results indicate that memory performance is the most important measure of disease severity and the main contributor to the decline in MMSE score at onset of clinical manifestation of Alzheimer's disease. In general, this suggests that memory should be the primary measure used in routine clinical care and the primary endpoint in clinical trials involving patients with Alzheimer's disease at onset of clinical manifestation. Changes in other measures of cognition should prompt consideration of possible comorbidities as a cause, rather than the impact of Alzheimer's disease itself.

Incidence and risk factors of SARS-CoV-2 breakthrough infection in the early Omicron variant era among vaccinated and boosted individuals in Chicago.

SARS-CoV-2 vaccines are safe and effective against infection and severe COVID-19 disease worldwide. Certain co-morbid conditions cause immune dysfunction and may reduce immune response to vaccination. In contrast, those with co-morbidities may practice infection prevention strategies. Thus, the real-world clinical impact of co-morbidities on SARS-CoV-2 infection in the recent post-vaccination period is not well established. This study was performed to understand the epidemiology of Omicron breakthrough infection and evaluate associations with number of comorbidities in a vaccinated and boosted population. A retrospective clinical cohort study was performed utilizing the Northwestern Medicine Enterprise Data Warehouse. Our study population was identified as fully vaccinated adults with at least one booster. The primary risk factor of interest was the number of co-morbidities. The primary outcome was the incidence and time to the first positive SARS-CoV-2 molecular test in the Omicron predominant era. Multivariable Cox modeling analyses to determine the hazard of SARS-CoV-2 infection were stratified by calendar time (Period 1: January 1 -June 30, 2022; Period 2: July 1 -December 31, 2022) due to violations in the proportional hazards assumption. In total, 133,191 patients were analyzed. During Period 1, having 3+ comorbidities was associated with increased hazard for breakthrough (HR = 1.16 CI 1.08-1.26). During Period 2 of the study, having 2 comorbidities (HR = 1.45 95% CI 1.26-1.67) and having 3+ comorbidities (HR 1.73, 95% CI 1.51-1.97) were associated with increased hazard for Omicron breakthrough. Older age was associated with decreased hazard in Period 1 of follow-up. Interaction terms for calendar time indicated significant changes in hazard for many factors between the first and second halves of the follow-up period. Omicron breakthrough is common with significantly higher risk for our most vulnerable patients with multiple co-morbidities. Age plays an important role in breakthrough infection with the highest incidence among young adults, which may be due to age-related behavioral factors. These findings reflect real-world differences in immunity and exposure risk behaviors for populations vulnerable to COVID-19.

Different endometrial preparation protocols on first frozen-thawed embryo transfer outcomes after hysteroscopic polypectomy: A retrospective cohort study.

To evaluate the optimal endometrial preparation protocol for frozen-thawed embryo transfer (FET) following hysteroscopic polypectomy. This was a retrospective clinical cohort study involving 464 patients who underwent their first FET after polyp resection between January 2021 and July 2023. The cohorts were categorized into three groups: the natural cycle (NC) group (n = 139), the ovarian induction (OI) group (n = 117), and the hormone replacement therapy (HRT) group (n = 208). In the initial unadjusted analysis, both NC and OI cycles exhibited similar pregnancy rates but were associated with significantly higher implantation rate (56.5%, 57.1% vs 42.0%, P < 0.001), clinical pregnancy rate (73.4%, 74.4% vs 57.2%, P = 0.001), and ongoing pregnancy rate (OPR; 67.6%, 63.2% vs 51.0%, P = 0.005) compared to the HRT group. Additionally, the three groups demonstrated comparable abortion rate (7.8%, 14.9% vs 10.9%, P = 0.299). After adjusting for potential confounders in the multiple logistic regression model, the HRT protocol resulted in a 54% significantly lower OPR compared to the NC protocol (adjusted odds ratio [aOR] = 0.46, 95% confidence interval [CI]: 0.28-0.77; P = 0.003). Meanwhile, the OPR difference between the OI protocol and the NC protocol remained insignificant (OI vs NC: aOR = 0.62, 95% CI: 0.35-1.12; P = 0.112). The ovulatory-FET scheme (NC and OI) following hysteroscopic polyp resection displayed promising clinical outcomes compared with HRT-FET scheme. The regimen without exogenous estrogen administration should be prioritized for endometrial preparation protocol after polypectomy.

Real‐World Incidence of Incident Noninfectious Uveitis in Patients Treated With BRAF Inhibitors: A Nationwide Clinical Cohort Study

To compare the incidence of noninfectious uveitis in skin melanoma or lung cancer patients who received BRAF inhibitors with that in those who received immune checkpoint inhibitors (ICIs) or conventional cytotoxic chemotherapy. Nationwide population-based retrospective clinical cohort study METHODS: From the Health Insurance Review and Assessment Service database of South Korea, we retrospectively defined 77,323 patients with skin melanoma or lung cancer who received BRAF inhibitor therapy (BRAF inhibitor-exposed group; n = 396), ICIs (ICI-exposed group; n = 22,474), or conventional cytotoxic chemotherapy (unexposed group; n = 54,453). We calculated the 1-year cumulative incidence of noninfectious uveitis in each group from the first day of BRAF inhibitor, ICI, or cytotoxic agent administration. During the first year of treatment initiation, the cumulative incidence of uveitis was 0.33%, 0.35%, and 2.27% in the unexposed, ICI-exposed, and BRAF inhibitor-exposed groups, respectively. Adjusted hazard ratios (aHR) indicated a 7.52-fold and 5.68-fold increased risk of uveitis in the BRAF inhibitor-exposed group compared with that in the unexposed and ICI-exposed groups (95% confidence interval [CI] 3.83-14.75, P < 0.001 and 95% CI 2.81-11.47, P < 0.001, respectively). After 1:4 propensity score matching, aHRs showed a 35.51-fold and 15.80-fold increased risk (95% CI 4.49-280.48, P = 0.001 and 95% CI 1.76-141.00, P = 0.014) of uveitis and severe uveitis, respectively, in the BRAF inhibitor-exposed versus unexposed patients. Crossover analysis within the BRAF inhibitor-exposed group showed a 3.71-fold increase in uveitis risk during 1-year post index date in comparison with 1-year prior to index date (95% CI 1.03-13.40, P = 0.046). In the BRAF inhibitor-exposed group, female sex, chronic kidney disease, and melanoma were associated with a trend of increased, albeit nonsignificant, risk of uveitis. Melanoma or lung cancer patients treated with BRAF inhibitors showed significantly higher risk of noninfectious uveitis than patients treated with conventional cytotoxic drugs or ICIs. These findings emphasize the importance of pretreatment patient education on BRAF-inhibitor-associated uveitis risk to enable prompt ophthalmic evaluation and treatment if symptoms arise during drug administration.

Comparative Accuracy of Barrett Integrated Keratometry Toric Calculator With Predicted Versus Measured Posterior Corneal Astigmatism.

To compare the prediction accuracy of the Barrett toric calculator using standard or integrated keratometry (IK) mode in combination with predicted or measured posterior corneal astigmatism (PCA) in a group of patients with cataract implanted with non-toric IOLs. In this retrospective clinical cohort study, the medical records of patients with age-related cataract who underwent phacoemulsification with the implantation of an aspheric monofocal IOL were reviewed. Four methods, including standard keratometry with predicted PCA (PPCA), IK combined with predicted PCA (IK-PPCA), and IK combined with measured PCA derived from IOLMaster 700 (Carl Zeiss Meditec AG) or CASIA2 (Tomey) (IK-MMPCA or IK-CMPCA), were applied to the Barrett toric calculator to calculate the predicted residual astigmatism. The mean absolute prediction error (MAPE), centroid of the prediction error, and proportion of eyes within the prediction error of ±0.50, ±0.75, and ±1.00 diopters (D) were all ciphered out from the four methods, respectively. Data from 129 eyes of 129 patients were included in this study. The MAPE of the IK-PPCA method (0.57 ± 0.36 D) was significantly smaller than that of the PPCA (0.62 ± 0.38 D) and IK-CMPCA (0.63 ± 0.46 D) methods (P = .048 and .014, respectively). There were no significant differences in the centroid vectors of prediction errors and predictability rates among the four methods (all P > .05). In the current version of the Barrett toric calculator, the predictive accuracy of the IK mode incorporating PPCA was slightly superior to using the standard keratometry mode or incorporating MPCA. [J Refract Surg. 2024;40(7):e453-e459.].

Analysis of the efficacy and adverse effects of nusinersen in the treatment of children with spinal muscular atrophy in China.

This study was based on a retrospective clinical observational cohort study of a two-center application of nusinersen in China to evaluate the clinical efficacy and adverse effects of nusinersen in the treatment of SMA (spinal muscular atrophy) Types 1-3. Clinical data from children with clinically and genetically confirmed 5qSMA from a double center in western China (the Second Affiliated Hospital of Xi'an Jiaotong University and the Second Hospital of West China of Sichuan University). All children were younger than 18 years of age. Patients were assessed for motor function and underwent blood and fluid tests before each nusinersen injection. At 14-month follow-up, 100% of children had improved their HFMSE (Hammersmith Functional Motor Scale Expanded) score, 83.6% had improved their CHOP INTEND (Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders) score, and 66.6% had improved their RULM (Revised Upper Limb Module) score by ≥3 points from baseline, and their 6MWT (6-min walk test) was 216.00±52.08m longer than at baseline. The age of the child at the start of treatment was negatively correlated with the clinical efficacy of nusinersen; the younger the child, the better the response to treatment. No significant adverse effects affecting the treatment and quality of life of the child were observed during the treatment of SMA with nusinersen. This study concluded that nusinersen is clinically beneficial for children with SMA in western China, with mild adverse effects.

The Effects of Presurgical Orthodontic Treatment on the Outcome of Secondary Bone Graft for Individuals With Cleft Lip and Palate

Background/Objective: Alveolar bone graft (ABG) or repair has become a routine part of treatment protocols for individuals with cleft lip and/or palate. However, the necessity and potential benefits of presurgical orthodontic treatment in influencing the outcomes of secondary alveolar bone grafting remain inconclusive. This systematic review aimed to assess the impact of presurgical orthodontics on preparing patients for secondary alveolar bone grafts. Study Design: The authors systematically searched for relevant articles in PubMed, Web of Science, and Embase databases spanning the period from January 1, 2000, to December 31, 2023, using keywords related to alveolar bone grafting and orthodontic treatment for patients with cleft lip and/or palate. The review encompassed various study designs, including prospective and retrospective studies, observational studies, cross-sectional studies, randomized and nonrandomized clinical trials, cohort studies, and case-control studies. The review adhered to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, and the risk of bias was evaluated in studies selected for full-text review. Results: The search strategy identified 809 publications. After initial screening and application of exclusion criteria, 11 studies were included for final review. Three were prospective studies, 8 were retrospective studies, and 3 were cross-sectional cohort studies. On the basis of ROBINS-I and RoB 2 risk assessment, 9 studies were found to be of moderate risk of bias, one study was categorized as of high risk of bias, and 1 study was categorized as low risk of bias. Conclusions: Drawing from the latest and most reliable studies, 7 out of 11 included studies provided compelling evidence that presurgical orthodontics preceding alveolar bone grafting (ABG) leads to significantly improved outcomes compared with cases without presurgical orthodontic intervention. Notably, individuals with specific conditions, such as severely collapsed upper arch and mispositioned upper incisors, appear to derive the greatest benefits from presurgical orthodontic treatment. However, a call for additional studies characterized by high methodological quality and with longer follow-up periods is emphasized to enhance the safety considerations for both practitioners and patients concerning the utilization of presurgical orthodontics in the treatment of individuals with cleft lip and palate.

Is Nuchal Translucency of 3.0–3.4 mm an Indication for cfDNA Testing or Microarray? – A Multicenter Retrospective Clinical Cohort Study

Introduction: This study aimed to evaluate the occurrence of clinically relevant (sub)microscopic chromosomal aberrations in fetuses with the nuchal translucency (NT) range from 3.0 to 3.4 mm, which would be potentially missed by cfDNA testing. Methods: A retrospective data analysis of 271 fetuses with NT between 3.0 and 3.4 mm and increased first trimester combined test (CT) risk in five cohorts of pregnant women referred for invasive testing and chromosomal microarray was performed. Results: A chromosomal aberration was identified in 18.8% fetuses (1:5; 51/271). In 15% (41/271) of cases, trisomy 21, 18, or 13 were found. In 0.7% (2/271) of cases, sex chromosome aneuploidy was found. In 1.1% (3/271) of cases, CNV >10 Mb was detected, which would potentially also be detected by genome-wide cfDNA testing. The residual risk for missing a submicroscopic chromosome aberration in the presented cohorts is 1.8% (1:54; 5/271). Conclusion: Our results indicate that a significant number of fetuses with increased CT risk and presenting NT of 3.0–3.4 mm carry a clinically relevant chromosomal abnormality other than common trisomy. Invasive testing should be offered, and counseling on NIPT should include the test limitations that may result in NIPT false-negative results in a substantial percentage of fetuses.

#1876 Pre-dialysis nutrition intervention is associated with delayed time to dialysis and survival after initiation of dialysis

Abstract Background and Aims Nutrition intervention (NI) is recommended in multidisciplinary pre-dialysis care as best evidence-based practice. NI aims to preserve kidney function, optimise nutritional status, attain optimal body weight/composition, and control complications and symptoms. However, understanding of its effectiveness on delaying dialysis and survival is limited. This study, Dietary Approaches to Manage Progressive and End stage Renal disease (DAMPER) study aimed to examine the effect of NI on time to dialysis and survival in patients attending a Kidney Disease Education Clinic (KDEC) and receiving structured NI from a dietitian. Method A retrospective clinical cohort study to examine patients who attended a KDEC at a metropolitan teaching hospital April 2002 through December 2019, followed up until December 2021. Associations of time to dialysis and mortality were compared between patients who received NI (NI group) and those who did not (no-NI group). Data were adjusted for baseline characteristics using Cox proportion hazard model, including age, gender, estimated glomerular filtration rate (eGFR), presence of co morbidities (e.g., diabetes mellitus, DM, peripheral vascular disease, PVD), and subjective global assessment (SGA) with score A=well-nourished, B or C=malnourished. Results 1138 patients attended the KDEC, 670 patients commenced dialysis and 538 met inclusion criteria for the study. 64.5% were male, median age 65 years (IQR 57–72), eGFR 15 mL/min/1.73 m2 (IQR 13–19), and prevalence of malnutrition (SGA=B and C) was 28.7%. 342 (63.6%) patients were in the NI group, only 84 (15.6%) had already commenced NI before KDEC. There was no statistical difference for the baseline age, gender, eGFR, PVD and DM (NS). However, prevalence of malnutrition was significantly higher in the non-NI group vs NI group (30.0% vs 28.1%, p = 0.002). By the end of the observation period, 503 (93.5%) patients had commenced dialysis, with 314/342 (91.8%) for the NI group vs 189/196 (96.4%) for the no-NI group (p = 0.037). The NI group reached dialysis significantly later compared to the no-NI group: 28.2 mo (95% CI 25.1–31.3) vs 18.8 mo (95% CI 15.7–22.0), respectively (log rank 0.000; hazard ratio [HR] 0.63; 95% CI 0.51–0.77; p = 0.000). Other factors significantly associated with time to dialysis were eGFR (p = 0.000) and PVD (p = 0.020). Age, gender, presence of malnutrition and diabetes were not associated with time to dialysis (NS). The NI-group was also associated with better survival compared to the no-NI group: time to mortality 116.6 mo (95% CI 106.1–127.2) vs 94.5 mo (95% CI 84.2-104.7), p = 0.001, respectively (log rank 0.005). None of these factors were independently associated with mortality (NS). Conclusion Structured pre-dialysis NI significantly delayed time to dialysis and reduced mortality risk in people with chronic kidney disease. Timely referral to NI is recommended in pre-dialysis care and KDEC provides an important platform for dietitians to initiate NI.

233. Predictors of Treatment Response to Repetitive Transcranial Magnetic Stimulation in Treatment-Resistant Depression: A Retrospective Clinical Cohort Study

233. Predictors of Treatment Response to Repetitive Transcranial Magnetic Stimulation in Treatment-Resistant Depression: A Retrospective Clinical Cohort Study

Clinical Longevity of Obturators in Patients with Jaw Defects: a Retrospective Cohort Study.

The primary objective of the present retrospective clinical study was to determine the survival time of obturators while analyzing possible influencing factors. This retrospective clinical cohort study analyzed the influence of various clinical factors on the survival probability of obturators and their follow-up outcomes using Kaplan‒Meier analysis. A total of 76 patients with 115 obturators were included in the study (47 men and 29 women, mean age 58.1 ± 18.1years). The mean observation time was 3.0 ± 4.5years (maximum 26.3years). A total of 40.9% (47) of all obturators observed had to be replaced. The survival rate after 5years was 79.5% for telescopic-crown-retained tooth-supported obturators, 86.9% for telescopic-crown-retained implant-supported obturators, 58.8% for removable full denture obturators, 22.1% for clasp-retained obturators and 0.0% for splints. The type of attachment, attendance at a regular follow-up and defect cause significantly influenced the survival of the obturators (p < .05). The findings obtained in this study support the recommendation of using implant-supported obturators. Telescopic-crown attachments, either tooth- or implant-supported, seem to be favorable in terms of survival time. Attendance at a strict follow-up program seems to have a major influence on the longevity of the obturators. The use of implant-supported obturators to cover permanent oral and maxillofacial defects is highly recommended. Additionally, the use of telescopic-crown attachments seems to be favorable in terms of survival time. Clasp-retained obturators and surgical splints should be used primarily for temporary restorations due to their shorter survival times.