METHODS: We studied the systematic use of SBA with a low profile, non-slip element device prior to DCB angioplasty in an unselected, non-randomized patient population. This prospective, all-comers study enrolled patients with de novo lesions as well as in-stent restenotic lesions in bare metal stents (BMS-ISR) and drug-eluting stents (DES-ISR). The primary endpoint was the target lesion failure (TLF) rate at 9 months (ClinicalTrials.gov Identifier NCT02554292).
RESULTS: A total of 481 patients (496 lesions) were recruited to treat de novo lesions (78.4%, 377), BMS-ISR (4.0%, 19), and DES-ISR (17.6%, 85). Overall risk factors were acute coronary syndrome (ACS, 20.6%, 99), diabetes mellitus (46.8%, 225), and atrial fibrillation (8.5%, 41). Average lesion lengths were 16.7 ± 10.4 mm in the de novo group, and 20.1 ± 8.9 mm (BMS-ISR) and 16.2 ± 9.8 mm (DES-ISR) in the ISR groups. Scoring balloon diameters were 2.43 ± 0.41 mm (de novo), 2.71 ± 0.31 mm (BMS-ISR), and 2.92 ± 0.42 mm (DES-ISR) whereas DCB diameters were 2.60 ± 0.39 mm (de novo), 3.00 ± 0.35 mm (BMS-ISR), and 3.10 ± 0.43 mm (DES-ISR), respectively. The overall accumulated TLF rate of 3.0% (14/463) was driven by significantly higher target lesion revascularization rates in the BMS-ISR (5.3%, 1/19) and the DES-ISR group (6.0%, 5/84). In de novo lesions, the TLF rate was 1.1% (4/360) without differences between calcified and non-calcified lesions (p = 0.158) and small vs. large reference vessel diameters with a cutoff value of 3.0 mm (p = 0.901).
CONCLUSIONS: The routine use of a non-slip element scoring balloon catheter to prepare lesions suitable for drug-coated balloon angioplasty is associated with high procedural success rates and low TLF rates in de novo lesions.
FUNDING: Pfizer.
METHODS: The 307 open-label extension (OLE) study (NCT03531255) is a non-randomized, multicenter extension study of long-term safety and efficacy of pegcetacoplan in adult patients with PNH who completed a pegcetacoplan parent study. All patients received pegcetacoplan. Outcomes at the 48-week data cutoff (week 48 of 307-OLE or August 27, 2021, whichever was earlier) are reported. Hemoglobin concentrations, Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scores, and transfusion avoidance were measured. Hemoglobin > 12 g/dL and sex-specific hemoglobin normalization (i.e., male, ≥ 13.6 g/dL; female, ≥ 12 g/dL) were assessed as percentage of patients with data available and no transfusions 60 days before data cutoff. Treatment-emergent adverse events, including hemolysis, were reported.
RESULTS: Data from 137 patients with at least one pegcetacoplan dose at data cutoff were analyzed. Mean (standard deviation [SD]) hemoglobin increased from 8.9 (1.22) g/dL at parent study baseline to 11.6 (2.17) g/dL at 307-OLE entry and 11.6 (1.94) g/dL at data cutoff. At parent study baseline, mean (SD) FACIT-Fatigue score of 34.1 (11.08) was below the general population norm of 43.6; scores improved to 42.8 (8.79) at 307-OLE entry and 42.4 (9.84) at data cutoff. In evaluable patients, hemoglobin > 12 g/dL occurred in 40.2% (43 of 107) and sex-specific hemoglobin normalization occurred in 31.8% (34 of 107) at data cutoff. Transfusion was not required for 114 of 137 patients (83.2%). Hemolysis was reported in 23 patients (16.8%). No thrombotic events or meningococcal infections occurred.
CONCLUSION: Pegcetacoplan sustained long-term improvements in hemoglobin concentrations, fatigue reduction, and transfusion burden. Long-term safety findings corroborate the favorable profile established for pegcetacoplan.
TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT03531255.
PATIENTS AND METHODS: Free buccal fat pad grafting was carried out in 15 patients in our institution. All were harvested using an intraoral approach. The buccal fat pad graft was used to correct periorbital contour depressions, nasal tip deformities, as a camouflage graft over exposed silicon nasal implants and as a filler in the depression deformity after mass excision.
RESULTS: All 15 patients demonstrated good contour deformity correction without a significant graft resorption up to 3 years of follow-up. There were no donor site complications. The amount used ranged from 1 to 5 cc in volume as a spacer or barrier for the moderate-sized volume defect or depression, even though more than 5 cc of fat graft could be harvested if required.
CONCLUSION: In conclusion, the buccal fat pad graft represents an easy, expedient and exceptional tool for the correction of contour deformities, volume replacement or for aesthetic augmentation.
LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
Objective: Due to resemblance of clinical symptoms of Ca ex PA and benign pleomorphic adenoma, it is mandatory for surgeons to keep high degree of clinical alertness, considering the peculiarity of this tumor.
Case Report: 54-year-old male presented with swelling on left side in the pre-auricular region from the middle of zygomatic arch to mastoid process and from tragus of the ear up to angle of mandible. Fine needle aspiration cytology revealed a mixture of benign and malignant components. Total left parotidectomy with left radical neck dissection followed by reconstruction with cervicodeltopectoral flap was performed. Combination of chemotherapy and radiotherapy were given to patient. Histologic examination and pre-operative fine needle aspiration cytology confirmed the diagnosis of Carcinoma ex pleomorphic adenoma (CA-ex-PA). Two-year follow-up of patient showed no recurrence of the lesion.
Conclusion: Due to the similarity in the clinical symptoms of CA-ex-PA and benign pleomorphic adenoma, it is vital that clinicians maintain a high degree of clinical vigilance, considering the oddity of this malignancy.
Objectives: This is a prevalence study that assessed the genetic diversity of chronic hepatitis B patients and coinfection.
Methods: Chronic hepatitis B patients enrolled in this study were tested for antibodies of other hepatitis viruses using ELISA kits. Patient clinical profiles were collected and partial genes of HBV, HCV, and HEV were amplified, sequenced, and analyzed using phylogenetic analysis. The associations between variables were determined using the chi-squared test.
Results: Of the 82 patients recruited for this study, 53.7% were non-cirrhotic, 22.0% cirrhotic, 20.7% acute flare and 3.7% hepatocellular carcinoma. Majority (58%) of patients had a high level of ALT (≥34 U/L). Sequence analysis showed HBV (63.9%) belonged to genotype B, HEV belonged to genotype 4 while HCV belonged to genotype 3a and the genotypes were found to be significantly associated with the clinical stage of the patients (χ2=56.632; p<0.01). Similarly, Hepatitis B e antigen was also found to be significantly associated with the clinical stage of infection (χ2=51.952; p<0.01).
Conclusion: This study revealed that genetic diversity was found to have a significant impact on the severity of infection.
METHODS: In the course of retrieval of data following MOOSE guidelines and PRISMA checklist, we found a total of fourteen studies that have been conducted during that period on altering sperm concentration in the African male.
RESULTS: Following analysis of the data, a time-dependent decline of sperm concentration (r = -0.597, p = 0.02) and an overall 72.6% decrease in mean sperm concentration was noted in the past 50 years. The major matter of concern is the present mean concentration (20.38×106/ml) is very near to WHO cut-off value of 2010 of 15×106/ml. Several epidemic diseases, genital tract infection, pesticides and heavy metal toxicity, regular consumption of tobacco and alcohol are reported as predominant causative factors.
CONCLUSION: This comprehensive, evidence-based meta-analysis and systematic review concisely presents the evidence of decreased sperm concentration in the African male over past 50 years with possible causative factors to serve the scientific research zone related to male reproductive health.
METHODS: A comprehensive systematic search was carried out in PubMed/MEDLINE, Web of Science, SCOPUS and Embase for RCTs that investigated the impact of vitamin D intake on circulating IGF-1 levels from inception until June 2019. Weighted mean difference (WMD) with the 95 % CI were applied for estimating combined effect size. Subgroup analysis was performed to specify the source of heterogeneity among studies.
RESULTS: Pooled results from eight studies demonstrated an overall non-significant increase in IGF-1 following vitamin D supplementation (WMD: 4 ng/ml, 95 % CI: -4 to 11). However, a significant degree of heterogeneity among studies was observed (I2 = 66 %). The subgroup analyses showed that vitamin D dosage of ≤1000 IU/day (WMD: 10 ng/ml) significantly increased IGF-1 compared to the vitamin D dosage of <1000 IU/day (WMD: -1 ng/ml). Moreover, intervention duration ≤12 weeks (WMD: 11 ng/ml) significantly increased IGF-1 compared to intervention duration <12 weeks (WMD: -3 ng/ml). In the epidemiological cohort study, participants under 60 years of age with a higher dietary vitamin D intake had significantly higher IGF-1 levels when compared to those with lower dietary vitamin D intake in second categories.
CONCLUSION: The main results indicate a non-significant increase in IGF-1 following vitamin D supplementation. Additionally, vitamin D dosages of <1000 IU/day and intervention durations of <12 weeks significantly raised IGF-1 levels.
METHODOLOGY: The data for the study consisting of 1067 community-dwelling older adults were obtained from a national survey entitled "Identifying Psychosocial and Identifying Economic Risk Factor of Cognitive Impairment among Elderly", conducted in Malaysia. The hypotension was considered as blood pressure <120/75 mm Hg, measuring by standard mercury manometer. Data analysis was performed using the SPSS Version 22.0.
RESULTS: The mean age of the respondents was 68.27 (SD = 5.93). Mean score of cognitive function as measured by MMSE was 22.70 (SD = 4.95). The prevalence of hypotension was 29.3%. The prevalence of cognitive impairment for hypotension group was 25.6%. Results of multiple linear regression analysis revealed that hypotension is negatively associated with cognitive function (Beta = -0.11, p
METHOD: The study included 2322 community-dwelling elderly in Malaysia, randomly selected through a multi-stage proportional cluster random sampling from Peninsular Malaysia. The elderly were surveyed on socio-demographic information, biomarkers, psychosocial status, disability, and cognitive function. A biopsychosocial model of cognitive function was developed to test variables' predictive power on cognitive function. Statistical analyses were performed using SPSS (version 15.0) in conjunction with Analysis of Moment Structures Graphics (AMOS 7.0).
RESULTS: The estimated theoretical model fitted the data well. Psychosocial stress and metabolic syndrome (MetS) negatively predicted cognitive function and psychosocial stress appeared as a main predictor. Socio-demographic characteristics, except gender, also had significant effects on cognitive function. However, disability failed to predict cognitive function.
CONCLUSION: Several factors together may predict cognitive function in the Malaysian elderly population, and the variance accounted for it is large enough to be considered substantial. Key factor associated with the elderly's cognitive function seems to be psychosocial well-being. Thus, psychosocial well-being should be included in the elderly assessment, apart from medical conditions, both in clinical and community setting.