Perinatal outcomes following fetoscopic laser surgery for early twin-to-twin transfusion syndrome: Systematic review and meta-analysis.

INTRODUCTION: Our objective was to investigate outcomes in twin-to-twin transfusion syndrome (TTTS) treated with fetoscopic laser surgery (FLS) at <18 weeks vs ≥18 weeks, and to conduct subgroup analysis of TTTS with FLS at <16 weeks vs 16-18 weeks. MATERIAL AND METHODS: PubMed, Scopus and Web of Science were searched systematically from inception until May 2023. Primary outcome was survival, and secondary outcomes included preterm premature rupture of membranes (PPROM), preterm birth and gestational age (GA) at delivery. RESULTS: Nine studies encompassing 1691 TTTS pregnancies were included. TTTS stage III was significantly more common in TTTS pregnancies treated with FLS at <18 weeks (odds ratio [OR] 2.84, 95% confidence interval [CI] 1.24-6.54), and procedure duration was shorter at <18 weeks (MD -5.27 minutes, 95% CI -9.19 to -1.34). GA at delivery was significantly earlier in TTTS pregnancies treated with FLS at <18 weeks (MD -3.12 weeks, 95% CI -6.11 to -0.13). There were no significant differences in outcomes, including PPROM, PPROM at <7 days post-FLS, preterm birth at <28 and <32 weeks, delivery at <7 days post-FLS, and survival outcomes, including fetal demise, live birth and neonatal survival. Similarly, TTTS stage III was more common in TTTS with FLS at <16 weeks than at 16-18 weeks (OR 2.95, 95% CI 1.62-5.35), with no significant differences in the aforementioned outcomes. CONCLUSIONS: In early TTTS treated with FLS, outcomes were comparable between those treated at <18 weeks compared with ≥18 weeks except for GA at delivery, which was 3 weeks earlier. In the subset treated at <16 weeks vs 16-18 weeks, the procedure was feasible without an increased risk of very early preterm birth or perinatal mortality.

Prenatal Risk Factors and Outcomes of Pseudoamniotic Band Sequence following Fetoscopic Laser Surgery: Systematic Review, and Meta-Analysis.

BACKGROUND: Pseudoamniotic band sequence (PABS) is a rare iatrogenic consequence of invasive fetal interventions, most commonly fetoscopic laser surgery (FLS) in monochorionic multiple pregnancies complicated by twin-to-twin transfusion syndrome (TTTS). OBJECTIVES: The aim of this study was to investigate prenatal risk factors and perinatal outcomes for pregnancies involving PABS after FLS for TTTS and compare outcomes between those undergoing fetoscopic band release versus not. METHOD: We conducted a systematic search of PubMed, Scopus, and Web of Science on studies reporting PABS following FLS for TTTS. A meta-analysis of pooled proportions was conducted. RESULTS: There were 16 studies covering 47 pregnancies complicated by PABS following FLS, mostly case series and case reports. The incidence of PABS was 2%, with the recipient twin affected in 94% of the cases. Pregnancies complicated by PABS were associated with inter-twin septostomy in 32% and chorioamniotic separation (CAS) in 90%. The mean gestational age (GA) at FLS and delivery were 17.7 and 30.9 weeks, respectively. Preterm premature rupture of membranes (PPROM) happened in 62% of pregnancies. The risk of preterm birth (PTB) <34 weeks, <32 weeks, and <28 weeks were 94%, 67%, and 31%, respectively. There were 41% fetal demises and 64% live births among the affected fetuses. Results of fetoscopic band release versus not were comparable, including GA at delivery, PPROM, and PTB at 32 weeks. It was noted that the likelihood of PTB by 28 weeks (67% vs. 23%) and fetal death (50% vs. 39%) were higher in the band release group. It was similar between groups in terms of postnatal amputation. CONCLUSIONS: PABS causes amputations or fetal death in more than one-third of cases. Pregnancies with an inter-twin septostomy, CAS, advanced TTTS staging, and early GA are more likely to experience PABS. In addition, more than a third of FLS-treated TTTS resulted in PTB and PPROM. PABS cases with prenatal band release showed higher rates of PTB and fetal death, but the data were from small, heterogeneous studies.

Fetal cardiac intervention in hypoplastic left heart syndrome with intact or restrictive atrial septum, systematic review, and meta-analysis.

To investigate outcomes of fetuses with hypoplastic left heart syndrome (HLHS) with an intact or restrictive atrial septum (I/RAS) managed expectantly or with fetal atrial septal intervention (FASI PubMed, Scopus, and Web of Science were searched systematically from inception until April 2023. Outcomes were classified by those who had FASI and those who had expectant management (EM). To estimate the overall proportion of each endpoint, a meta-analysis of proportions was employed using a random-effects model. Heterogeneity was assessed using the I2 value. Thirty-two studies reporting on 746 fetuses with HLHS and I/RAS met our inclusion criteria. Eleven studies (123 fetuses) were in the FASI group and 21 studies (623 fetuses) were in the EM group. Among the 123 FASI cases, 107 (87%) were reported to be technically successful. The mean gestational age (GA) at diagnosis was comparable between the groups (26.2 weeks FASI vs. 24.4 weeks EM group). The mean GA at FASI was 30.4 weeks (95% CI 28.5, 32.5). The mean GA at delivery was also comparable (37.7 weeks FASI vs. 38.1 weeks EM group). Neonatal outcomes, including live birth, neonatal death, and survival to hospital discharge pooled proportions, were also comparable between groups (live birth: 92% (95% CI 64, 99) FASI versus 93% (95% CI 79, 98) in EM, neonatal death: 32% (95% CI 11, 65) FASI versus 30% (95% CI 21, 41) EM, survival to hospital discharge: 37% (95% CI 25, 52) FASI versus 52% (95% CI 42, 61) EM). Age at neonatal death was higher in the FASI group (mean: 17 days FASI vs. 7.2 days EM group). There was a lower rate of postnatal atrial restrictive septum in the FASI group 38% (95% CI 17, 63) compared to the EM group 88% (95% CI 57, 98). Our review shows variations across centers in the selection criteria and techniques used for FASI. Although survival including livebirth, neonatal death, and survival to hospital discharge did not differ between groups, the procedure may translate into a less restrictive septum at birth. Future multicenter studies are needed to better identify the subset of cases that might have improved outcomes, use standardized definitions, unified techniques, utilize core outcome set, and assess long-term benefits.

Transplacental non-steroidal anti-inflammatory drugs versus expectant management in fetal Ebstein anomaly with circular shunt: Systematic review and meta-analysis.

Ebstein anomaly (EA) is a rare congenital cardiac malformation associated with high perinatal mortality. In this systematic review and meta-analysis, we aimed to investigate the outcomes of pregnancies affected by EA or tricuspid valve dysplasia (TVD) with circular shunt, focusing on two prenatal management approaches: (1) expectant management (EM) and (2) transplacental non-steroidal anti-inflammatory drugs (NSAID) therapy. We searched PubMed, Scopus, and Web of Science systematically from its inception until June 2023. The random-effect model was used to pool the data. Heterogeneity was assessed using the I2 value. Twenty-one studies with a total of 610 fetuses with EA/TVD with circular shunt were included in the synthesis, of which 17 studies (583 fetuses) were on EM and 4 studies (27 fetuses) used transplacental NSAID therapy. The NSAID group had higher rates of moderate to severe tricuspid regurgitation, hydrops, and pericardial effusion on prenatal ultrasound compared with the EM group. However, ductal constriction was achieved in 81% of NSAID cases, mitigating the disease pathophysiology, although 65% of them experienced oligohydramnios. Notably, the NSAID group showed significantly higher rates of live birth (86%) and survival to hospital discharge (89%) compared with the EM group (67% and 43%, respectively). Despite these promising results, it's important to acknowledge that the number of cases treated with NSAIDs was small, with limited safety data. Therefore, caution is advised in interpreting these findings, and patients considering NSAID therapy should be informed about these limitations. Future multicenter studies are necessary to further explore the safety and effectiveness of NSAID therapy in this particular population.

External-internal cranial expansion to treat patients with craniocerebral disproportion due to post-shunt craniosynostosis: a case series.

INTRODUCTION: Secondary craniosynostosis subsequent to shunting is one of the late complications of ventricular shunt placement in the early childhood. Several interventions have been used to treat high intracranial pressure associated with this condition. This study aimed to evaluate the patients' clinical symptoms and head circumference before and after a method of decompressive craniotomy, coined as external-internal cranial expansion (EICE). METHODS: A retrospective study was conducted, and the patients who had undergone EICE for the treatment of post-shunt craniosynostosis between 2010 and 2020 were enrolled. This approach was a combination of a hinge multiple-strut decompressive craniectomy and internal cranial flap thinning by drill. Data, extracted from medical records, were used to evaluate the patients' symptoms and head circumferences before and 12 months after surgery. RESULTS: A total of 16 patients were enrolled in the study, of which eight were females. Before the surgery, 9 patients (56.2%) suffered from visual impairment, and all had intractable headache. Papilledema was recorded in all, with 3 cases having optic disc paleness. After cranial expansion, only two patients had headaches, diagnosed as migraine-type and psychosomatic headaches, respectively. In two patients, progressive visual impairments got worsening after surgery, which would be due to severe preoperative optic nerve atrophy. Patients' head circumferences significantly increased after the surgery (mean of 48.97 ± 4.28 cm vs. 45.78 ± 4.31 cm; P value < 0.0001). CONCLUSION: In lower resource countries, where newer technologies like distraction osteogenesis is not easily available, external-internal cranial expansion can be considered an effective alternative for patients with post-shunt craniosynostosis.

Implementation of supervised physical training to reduce vasovagal syncope recurrence: A randomized controlled trial.

INTRODUCTION: Physical techniques used for the prevention of vasovagal syncope have limited evidence for efficacy. We aimed to evaluate multimodal supervised physical training as a treatment approach. METHODS: In this 1:1 randomized trial, patients with ≥2 episodes of clinically diagnosed vasovagal syncope were included. On top of standard care, the intervention arm performed supervised tilt training and aerobic exercise in six sessions at a cardiac rehabilitation center (three sessions during the first month, and then at 3-month intervals), plus home tilt training. The control arm received standard care with a similar protocol of home tilt training. The primary outcome was time to first syncopal recurrence during 1 year of follow-up. RESULTS: Fifty participants were randomized (mean age: 34.5 ± 14.8 years; 64% female). The rate of syncopal recurrence was 28% and 64% within the intervention and control arms, respectively, with significantly higher syncope-free survival at 1 year in the intervention arm (Log-rank p = .003). The frequency of recurrent syncopal events was significantly lower with physical training (p = .017). Participants in the intervention arm reported significantly higher adherence to the home tilt training program (80% vs. 52%; p = .037). CONCLUSION: Among patients with recurrent vasovagal syncope, a supervised program of tilt training and aerobic exercise reduced syncopal recurrence. Future trials are warranted to further investigate multimodal supervised physical techniques as a therapeutic approach in treating vasovagal syncope.

Single fetal demise following fetoscopic ablation for twin-to-twin transfusion syndrome-cohort study, systematic review, and meta-analysis.

BACKGROUND: Several studies have assessed preoperative and operative factors associated with fetal demise after laser for TTTS, yet these findings are not completely conclusive. OBJECTIVE: This study aimed to identify risk factors for single fetal demise (recipient and donor twins) after fetoscopic laser photocoagulation for twin-to-twin transfusion syndrome. STUDY DESIGN: We searched PubMed, Scopus, and Web of Science systematically from the inception of the database to June 2020. We conducted a systemic review on studies investigating risk factors for fetal demise (donor and/or recipient) after fetoscopic laser photocoagulation in monochorionic pregnancies complicated with twin-to-twin transfusion syndrome. Initially, we investigated the cohort of women with twin-to-twin transfusion syndrome that underwent fetoscopic laser photocoagulation at our 2 high-volume fetal centers between 2012 and 2020 to identify risk factors for donor demise and recipient demise. Furthermore, we conducted a systematic review of the literature to better characterize these factors. Among studies that met the entry criteria, multiple preoperative and operative factors were tabulated. The random-effect model was used to pool the standardized mean differences or odds ratios and corresponding 95% confidence intervals. Heterogeneity was assessed using the I2 value. RESULTS: A total of 514 pregnancies with twin-to-twin transfusion syndrome managed with fetoscopic laser photocoagulation were included in the final analysis. Following the logistic regression, factors that remained significant for donor demise were selective fetal growth restriction (odds ratio, 1.9; 95% confidence interval, 1.3-2.8; P=.001) and umbilical artery blood flow with absent or reversed end-diastolic velocity of the donor (odds ratio, 2.06; 95% confidence interval, 1.2-3.4; P=.004). A significant factor associated with recipient demise was absent or reversed a-wave in the ductus venosus of the recipient (odds ratio, 1.74; 95% confidence interval, 1.07-3.13; P=.04). Data from 23 studies and our current cohort were included. A total of 4892 pregnancies with twin-to-twin transfusion syndrome managed with fetoscopic laser photocoagulation were analyzed for risk factors for donor demise, and 4594 pregnancies with twin-to-twin transfusion syndrome were analyzed for recipient demise. Among studies, the overall incidence rates ranged from 10.9% to 35.8% for donor demise and 7.3% to 24.5% for recipient demise. Significant risk factors for donor demise were intertwin estimated fetal weight discordance of >25% (odds ratio, 1.86; 95% confidence interval, 1.44-2.4; I2, 0.0%), selective fetal growth restriction (odds ratio, 1.78; 95% confidence interval, 1.4-2.27; I2, 0.0%), twin-to-twin transfusion syndrome stage III (odds ratio, 2.18; 95% confidence interval, 1.53-3.12; I2, 0.0%), umbilical artery blood flow with absent or reversed end-diastolic velocity of the donor (odds ratio, 2.31; 95% confidence interval, 1.9-2.8; I2, 23.7%), absent or reversed a-wave in the ductus venosus of the donor (odds ratio, 1.83; 95% confidence interval, 1.45-2.3; I2, 0.0%), and presence of arterioarterial anastomoses (odds ratio, 2.81; 95% confidence interval, 1.35-5.85; I2, 90.7%). Sequential selective coagulation was protective against donor demise (odds ratio, 0.31; 95% confidence interval, 0.16-0.58; I2, 0.0%). Significant risk factors for recipient demise were twin-to-twin transfusion syndrome stage IV (odds ratio, 2.18; 95% confidence interval, 1.01-4.6; I2, 16.5%), umbilical artery blood flow with absent or reversed end-diastolic velocity of the recipient (odds ratio, 2.68; 95% confidence interval, 1.91-3.74; I2, 0.0%), absent or reversed a-wave in the ductus venosus of the recipient (odds ratio, 2.37; 95% confidence interval, 1.55-3.64; I2, 60.2%), and middle cerebral artery peak systolic velocity of >1.5 multiple of the median (odds ratio, 3.06; 95% confidence interval, 1.36-6.88; I2, 0.0%). CONCLUSION: Abnormal blood flow patterns represented by abnormal Doppler studies and low fetal weight were associated with single fetal demise in women with twin-to-twin transfusion syndrome undergoing laser therapy. Although sequential selective coagulation was protective against donor demise, the presence of arterioarterial anastomoses was considerably associated with donor demise. This meta-analysis extensively investigated the association of a wide range of preoperative and operative factors with fetal demise. These findings may be important inpatient counseling, in further understanding the disease, and perhaps in improving surgical techniques.

Prevalence of short and long sleep duration: Ravansar NonCommunicable Disease (RaNCD) cohort study.

BACKGROUND: Prevalence of short and long sleep duration varies in different countries and changes over time. There are limited studies on Iranians' sleep duration, and we aimed to evaluate the prevalence of short and long sleep duration and associated factors among people living in Kermanshah, Iran. METHODS: This population-based cross-sectional study was conducted between November 2014 and February 2017. Data was collected from 10,025 adults aged 35 to 65 years using census sampling, and we evaluated the short and long sleep duration (≤ 6 and ≥ 9 h, respectively) and its relation with the socio-demographic factors and health-related status of the participants. RESULTS: Mean age of participants was 48.1 years (standard deviation = 8.2), and 47.4% of participants were male. Of our participants, 11.6% had short, and 21.9% had long sleep duration. Age ≥ 50 years, female gender, being single, mobile use for longer than 8 h per day, working in night shifts, moderate and good levels of physical activity, BMI ≥ 30, past smoking, and alcohol use were associated with short sleep duration (P < 0.05). Female gender and living in rural areas were associated with long sleep duration (P < 0.05). CONCLUSION: In the Ravansar population, short and long sleep duration are prevalent, with long sleep duration having higher prevalence. People at risk, such as night shift workers, as well as modifiable factors, such as mobile phone use, can be targeted with interventions to improve sleep hygiene.

Comparison of cytopathologic findings in patients with negative Pap test and positive high-risk HPV infection among three groups.

PURPOSE: Comparison of colposcopy-guided biopsy and endocervical cytologic (ECC) results in patients with negative Papanicolaou (Pap) and positive high-risk (HR) HPV tests in the three groups of HPV 16/18, non-16/18 HR-HPV (other HR-HPV), and concurrent infection of either HPV 16/18 and at least one subtype of other HR-HPVs. METHODS: This cross-sectional study was conducted among women aged 30-65 who had negative Pap and positive HR-HPV DNA tests. Pap test was performed using liquid cytology. For HPV DNA testing, the polymerase chain reaction (PCR) method was used. RESULTS: Among 394 participants, 111 (28.2%) were in the HPV 16/18, 226 (57.4%) in the Other HR-HPV, and 57 (14.4%) in the concurrent group. The mean age of participants was 35.71 ± 7.1 years. Cervical intraepithelial neoplasia (CIN) grade 2/3 were seen in 29 (26.1%) patients of HPV 16/18, 60 (26.5%) of other HR-HPV, and 18 (31.6%) of concurrent infection group (P = 0.593). HPV 52 was the most common subtype in the other HR-HPV group (15%). CONCLUSIONS: The risk of high-grade CIN lesions in patients with negative Pap test and positive other HR-HPV was not significantly less than patients with positive HPV 16/18. Besides, the risk of losing the patients to 1-year follow-up seems high.

Maternal mortality and its determining factors among hospitalised mothers in Tehran, Iran, 2013-2020.

The maternal mortality ratio (MMR) is a significant indicator of the quality of a health care system. Despite considerable progress in reducing MMR in Iran in the past few years, we still face a long road ahead in eliminating preventable maternal deaths. In the present study, we evaluated all 80 cases of maternal deaths in 20 hospitals under the supervision of Tehran University of Medical Sciences between March 20 2013 and March 19 2020. During this time, these hospitals recorded 335,216 live births, with an MMR of 24 per 100,000 live births. The average age of deceased mothers was 31.9 ± 6.9 years. Direct causes accounted for 48.75% of maternal deaths, with haemorrhage being the most common direct cause of mortality (17.5%). Moreover, cancer (17.5%) and cardiovascular diseases (17.5%) were the most common indirect causes of maternal mortality. Even after accounting for the COVID-19 pandemic's effects, we have noticed an increase in maternal mortality. As a result, implementing a comprehensive approach for high-risk pregnancies is critical.Impact StatementWhat is already known on this subject? Although we have been able to reduce MMR in Iran to a reasonable level, previous measures would not be sufficient to accomplish future goals. Furthermore, we have a long way to go before reaching the ultimate goal of eradicating avoidable maternal deaths by 2030.What do the results of this study add? The causes, determinants and risk factors of maternal mortality were investigated in this study. With this level of detail, we can observe a steadily increase in MMR in recent years, regardless of the COVID-19 pandemic. The majority of pregnancy-related deaths can be avoided.What are the implications of these findings for clinical practice and/or further research? MMR reduction is a measurable goal that can be attained by improving financial resources, implementing safe delivery, team training, preparing multidisciplinary care with integration for high-risk pregnant women, establishing good provider relationships, and communicating with patients and providers for early warning signs and structural changes.

Different incidences of acute kidney injury (AKI) and outcomes in COVID-19 patients with and without non-azithromycin antibiotics: A retrospective study.

In late December 2019, an outbreak of a novel coronavirus which caused coronavirus disease 2019 (COVID-19) was initiated. Acute kidney injury (AKI) was associated with higher severity and mortality of COVID-19. We aimed to evaluate the effects of comorbidities and medications in addition to determining the association between AKI, antibiotics against coinfections (AAC) and outcomes of patients. We conducted a retrospective study on adult patients hospitalized with COVID-19 in a tertiary center. Our primary outcomes were the incidence rate of AKI based on comorbidities and medications. The secondary outcome was to determine mortality, intensive care unit (ICU) admission, and prolonged hospitalization by AKI and AAC. Univariable and multivariable logistic regression method was used to explore predictive effects of AKI and AAC on outcomes. Out of 854 included participants, 118 patients developed AKI in whom, 57 used AAC and 61 did not. Hypertension and diabetes were the most common comorbidities in patients developed AKI. AAC, lopinavir/ritonavir, ribavirin, angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers, and corticosteroids had significant higher rate of administration in patients developed AKI. AAC were associated with higher deaths (odds ratio [OR] = 5.13; 95% confidence interval (CI): 3-8.78) and ICU admission (OR = 5.87; 95%CI: 2.81-12.27), while AKI had higher OR for prolonged hospitalization (3.37; 95%CI: 1.76-6.45). Both AKI and AAC are associated with poor prognosis of COVID-19. Defining strict criteria regarding indications and types of antibiotics would help overcoming concomitant infections and minimizing related adverse events.

Effect of composite radiopacity and margin location of the restoration on the diagnosis of secondary caries.

This research aimed to evaluate the effect of the radiopacity of a Bulk-Fill composite (X-TraFil, VOCO, Germany) and a Conventional composite (P60, 3M ESPE, USA) and assessment of the margin location in the enamel and dentin on the diagnosis of secondary caries. 76 intact premolars with MOD preparation were divided into two equal groups and filled with the conventional and bulk-fill composite. Four regions were considered to simulate carious lesions (two regions in enamel and two regions in dentin). In each group, half of the regions in the dentin and half in the enamel were randomly selected for secondary caries simulation and filled with a wax-plaster combination while the remaining regions stayed intact. Bitewing imaging was done using the PSP digital sensor. Five examiners reviewed the images, and lesions were recorded. Caries diagnosis indicators and paired-sample t-test were used for statistical analysis. The reproducibility and accuracy of the examiners' responses were evaluated using the kappa and agreement coefficient (α=0.05). The sensitivity, specificity, and accuracy of diagnosing secondary carious lesions in enamel were significantly better under conventional than bulk-fill composite. Similarly, the sensitivity and accuracy of diagnosing secondary caries in dentin were significantly higher under conventional composite than bulk-fill composite (p<0.05). No significant differences were found in the agreement and kappa coefficient between conventional and bulk-fill composites in the enamel and dentin (p>0.05). The diagnostic accuracy of carious lesions was higher under conventional composite than bulk-fill composite. However, the location of the secondary was ineffective in caries diagnosis.

Automated diagnosis of autism with artificial intelligence: State of the art.

Autism spectrum disorder (ASD) represents a panel of conditions that begin during the developmental period and result in impairments of personal, social, academic, or occupational functioning. Early diagnosis is directly related to a better prognosis. Unfortunately, the diagnosis of ASD requires a long and exhausting subjective process. We aimed to review the state of the art for automated autism diagnosis and recognition in this research. In February 2022, we searched multiple databases and sources of gray literature for eligible studies. We used an adapted version of the QUADAS-2 tool to assess the risk of bias in the studies. A brief report of the methods and results of each study is presented. Data were synthesized for each modality separately using the Split Component Synthesis (SCS) method. We assessed heterogeneity using the I 2 statistics and evaluated publication bias using trim and fill tests combined with ln DOR. Confidence in cumulative evidence was assessed using the GRADE approach for diagnostic studies. We included 344 studies from 186,020 participants (51,129 are estimated to be unique) for nine different modalities in this review, from which 232 reported sufficient data for meta-analysis. The area under the curve was in the range of 0.71-0.90 for all the modalities. The studies on EEG data provided the best accuracy, with the area under the curve ranging between 0.85 and 0.93. We found that the literature is rife with bias and methodological/reporting flaws. Recommendations are provided for future research to provide better studies and fill in the current knowledge gaps.

Long-Term Effects of Opium Consumption Following Percutaneous Coronary Intervention: A 10-year Follow-Up Study.

Background: Opium consumption has been an overlooked health issue in the Iranian population, and the prognostic role of opium consumption in patients undergoing coronary revascularization is unknown. Hypothesis: We aimed to assess the association between opium consumption and long-term cardiovascular outcomes after percutaneous coronary intervention (PCI). Methods: We screened 2203 consecutive patients who underwent elective PCI between April 2009 and April 2010 at Tehran Heart Center. Exclusion criteria were unsuccessful PCI, non-elective PCI, and missing opium use data. Opium consumption was defined as self-reported ever use of any traditional opium substances. Outcomes of interest were all-cause mortality and a composite of major adverse cardiac and cerebrovascular events (MACCE). The association between opium use and study outcomes was evaluated using the inverse probability of treatment weighting (IPTW) method. Cumulative hazard curves were demonstrated to further assess the association visually. Furthermore, the effect of opium consumption on individual components of MACCE was evaluated in a competing risk setting. Results: A total of 2025 elective PCI patients were included (age: 58.7 ± 10.67, 29.1% women), among whom 297 (14.6%) patients were opium users. After a median follow-up of 10.7 years, opium consumption was associated with a higher risk of all-cause mortality (IPTW-hazard ratio [HR] = 1.705, 95% CI: 1.125-2.585; P = 0.012) and MACCE (IPTW-HR = 1.578, 95% CI: 1.156-2.153; P = 0.004). The assessment of MACCE components suggested a non-significant borderline trend for higher non-fatal myocardial infarction (IPTW-sub-distribution HR [SHR] = 1.731, 95% CI: 0.928-3.231; P = 0.084) and mortality (IPTW-SHR = 1.441, 95% CI: 0.884-2.351; P = 0.143) among opium users. Conclusions: Opium consumption is associated with a more than 50% increase in long-term risk of mortality and MACCE in patients undergoing PCI. These findings accentuate the importance of preventive strategies to quit opium addiction in this population.

Prepregnancy Roux-en-Y gastric bypass vs sleeve gastrectomy: a systematic review, pairwise, and network meta-analysis of obstetrical and neonatal outcomes.

OBJECTIVE: This study aimed to systematically investigate a wide range of obstetrical and neonatal outcomes with respect to 2 types of prepregnancy bariatric surgery, Roux-en-Y gastric bypass and sleeve gastrectomy, through: (1) providing a meta-analysis of the effect of bariatric surgery (Roux-en-Y gastric bypass vs no surgery and, separately, sleeve gastrectomy vs no surgery) on adverse obstetrical and neonatal outcomes, and (2) comparing the relative benefit of Roux-en-Y gastric bypass vs sleeve gastrectomy using both conventional and network meta-analysis. DATA SOURCES: We searched PubMed, Scopus, and Embase systematically from inception up to April 30, 2021. ELIGIBILITY CRITERIA: Studies reporting on pregnancies' obstetrical and neonatal outcomes with respect to 2 types of prepregnancy bariatric surgery-Roux-en-Y gastric bypass and sleeve gastrectomy-were included. The included studies either indirectly compared between the procedure and controls or directly compared between the 2 procedures. METHODS: We performed a systematic review followed by pairwise and network meta-analysis in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. In the pairwise analysis, multiple obstetrical and neonatal outcomes were tabulated and compared between 3 groups: (1) Roux-en-Y gastric bypass vs controls, (2) sleeve gastrectomy vs controls, and (3) Roux-en-Y gastric bypass vs sleeve gastrectomy. Primary outcomes included small for gestational age, large for gestational age, gestational hypertension/preeclampsia, and gestational diabetes mellitus. Secondary outcomes included preterm birth, anemia, cesarean delivery, and biochemical profile. The random-effects model was used to pool the mean differences or odds ratios and the corresponding 95% confidence intervals. Heterogeneity was assessed using the I2 value. The Newcastle-Ottawa scale was used to assess individual study quality. To resolve inconclusive findings and to rank current treatments, network meta-analysis was conducted for the primary outcomes. Quality of evidence was assessed with the Confidence in Network Meta-Analysis approach and the GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) tool within the summary of findings table. RESULTS: A total of 20 studies were included, reporting on 40,108 pregnancies, of which 5194 underwent Roux-en-Y gastric bypass, 405 underwent sleeve gastrectomy, and 34,509 were controls. Compared with controls, Roux-en-Y gastric bypass increased the risk of small for gestational age infants (odds ratio, 2.56; 95% confidence interval, 1.77-3.70; I2, 29.1%; P<.00001), decreased the risk of large for gestational age infants (odds ratio, 0.25; 95% confidence interval, 0.18-0.35; I2, 0%; P<.00001), decreased gestational hypertension/preeclampsia (odds ratio, 0.54; 95% confidence interval, 0.30-0.97; I2, 26.8%; P=.04), decreased gestational diabetes mellitus (odds ratio, 0.43; 95% confidence interval, 0.23-0.81; I2, 32%; P=.008), increased maternal anemia (odds ratio, 2.70; 95% confidence interval, 1.53-4.79; I2, 40.5%; P<.001), increased neonatal intensive care unit admission (odds ratio, 1.36; 95% confidence interval, 1.04-1.77; I2, 0%; P=.02), and decreased mean gestational weight gain (mean difference, -3.37 kg; 95% confidence interval, -5.62 to -1.11; I2, 65.3%; P=.003). Only 3 studies compared sleeve gastrectomy with controls, and found no significant differences in primary outcomes or in mean gestational weight gain. The network meta-analysis showed that Roux-en-Y gastric bypass (malabsorptive procedure) resulted in greater decrease of large for gestational age, gestational hypertension/preeclampsia, and gestational diabetes mellitus, and a greater increase in small for gestational age infants when compared with sleeve gastrectomy (restrictive procedure). However, the small number of studies, small number of sleeve gastrectomy patients, limited outcomes, and data heterogeneity resulted in low-to-moderate network GRADE of evidence. CONCLUSION: This network meta-analysis showed that Roux-en-Y gastric bypass, compared with sleeve gastrectomy, resulted in greater decrease in large for gestational age, gestational hypertension/preeclampsia, and gestational diabetes mellitus, but in greater increase in small for gestational age infants. Certainty of evidence in the network meta-analysis was of a low-to-moderate GRADE. Evidence is still lacking for periconception biochemical profile, congenital malformations, and reproductive health outcomes for both interventions; thus, future well-designed prospective studies are needed to further characterize these outcomes.

The Impact of the COVID-19 Pandemic on Hospitalization Rates due to Prosthetic Valve Thrombosis.

Background: Studies have shown a decline in the admission rates of various diseases during the COVID-19 pandemic. Prosthetic valve thrombosis (PVT) is a rare condition followed by surgical or transcatheter valvular interventions. Considering the lack of data on hospitalization rates due to PVT during the pandemic, this study evaluated the implications of the COVID-19 pandemic on PVT admissions and characteristics in a tertiary referral center. Methods: Data from all the consecutive patients hospitalized due to PVT between February 2020 and February 2021 (the first year of the pandemic) were collected from medical records and compared clinically with the corresponding time before the pandemic (February 2019 through February 2020). Variables of interest included the number of hospitalization, patient and valve characteristics, diagnostic and management strategies, and in-hospital events. Results: Forty patients (32.5% male, age: 54.0 [46.5-62.0 y] comprised the study population. We observed a considerable decline in hospitalization rates during the pandemic, from 31 to 9 patients. Admitted patients were 8 years younger, had a higher proportion of the New York Heart Association functional class III or IV symptoms (44.4% vs 22.6%), were more often treated with fibrinolysis (33.3% vs 22.6%) or surgical approaches (33.3% vs 22.6%), and were discharged 6 days sooner. Conclusion: We described a reduction in PVT hospitalization. Patients presented with a higher proportion of severe dyspnea and had increased treatment with fibrinolysis/surgical approaches. These observations highlight the necessity of the active surveillance of patients with prosthetic valves by caregivers for timely diagnosis and appropriate management during the pandemic.

Biomaterial-based delivery platforms for transdermal immunotherapy.

Nowadays, immunotherapy is one of the most essential treatments for various diseases and a broad spectrum of disorders are assumed to be treated by altering the function of the immune system. For this reason, immunotherapy has attracted a great deal of attention and numerous studies on different approaches for immunotherapies have been investigated, using multiple biomaterials and carriers, from nanoparticles (NPs) to microneedles (MNs). In this review, the immunotherapy strategies, biomaterials, devices, and diseases supposed to be treated by immunotherapeutic strategies are reviewed. Several transdermal therapeutic methods, including semisolids, skin patches, chemical, and physical skin penetration enhancers, are discussed. MNs are the most frequent devices implemented in transdermal immunotherapy of cancers (e.g., melanoma, squamous cell carcinoma, cervical, and breast cancer), infectious (e.g., COVID-19), allergic and autoimmune disorders (e.g., Duchenne's muscular dystrophy and Pollinosis). The biomaterials used in transdermal immunotherapy vary in shape, size, and sensitivity to external stimuli (e.g., magnetic field, photo, redox, pH, thermal, and even multi-stimuli-responsive) were reported. Correspondingly, vesicle-based NPs, including niosomes, transferosomes, ethosomes, microemulsions, transfersomes, and exosomes, are also discussed. In addition, transdermal immunotherapy using vaccines has been reviewed for Ebola, Neisseria gonorrhoeae, Hepatitis B virus, Influenza virus, respiratory syncytial virus, Hand-foot-and-mouth disease, and Tetanus.

Successful management of a patient with ovarian ectopic pregnancy by the end of the first trimester: a case report.

BACKGROUND: Among all ectopic pregnancies, between 0.5% and 3.5% are ovarian ectopic pregnancies, a potentially life-threatening condition when ruptured due to its serious potential for hemorrhaging. A majority of ovarian ectopic pregnancies are diagnosed by the 7th week of pregnancy when the patient becomes symptomatic, and ultrasound can be used to diagnose this condition. CASE PRESENTATION: We present the case of a 39-year-old Persian woman in the 12th week of gestation who presented with vaginal bleeding and abdominal pain and was diagnosed with ovarian ectopic pregnancy. Her notable laboratory finding was ß-human chorionic gonadotropin > 15,000, which indicates definite pregnancy. Transvaginal ultrasound (TVS) revealed no evidence of intrauterine pregnancy, but a well-circumscribed gestational sac in the left ovary. The patient was successfully treated with resection of the gestational sac and partial left salpingo-oophorectomy. Histopathological studies confirmed the diagnosis of ovarian ectopic pregnancy. CONCLUSION: The case emphasizes the ability of ovarian ectopic pregnancy to develop asymptomatically through the course of pregnancy and points to the necessity for high-quality prenatal care and the importance of determining the fetal site during pregnancy.

Gestational weight gain below instead of within the guidelines per class of maternal obesity: a systematic review and meta-analysis of obstetrical and neonatal outcomes.

OBJECTIVE: This study aimed to systematically investigate a wide range of obstetrical and neonatal outcomes as they relate to gestational weight gain less than the current Institute of Medicine and the American College of Obstetricians and Gynecologists guidelines when compared with weight gain within the guideline range and to stratify outcomes by the class of obesity and by the type of study analysis. DATA SOURCES: We systematically searched studies on PubMed, Scopus, Embase, and the Cochrane Library from 2009 to April 30, 2021. STUDY ELIGIBILITY CRITERIA: Studies reporting on obstetrical and neonatal outcomes of singleton pregnancies related to gestational weight gain less than the current Institute of Medicine and the American College of Obstetricians and Gynecologists guidelines in comparison with weight gain within the guidelines among women with obesity overall (body mass index >30 kg/m2) and/or a specific class of obesity (I: body mass index, 30-34.9 kg/m2; II: body mass index, 35-39.9 kg/m2; and III: body mass index >40 kg/m2). METHODS: Among the studies that met the inclusion criteria, multiple obstetrical and neonatal outcomes were tabulated and compared between pregnancies with weight gain less than recommended in the guidelines and those with weight gain within the guidelines, further classified by the class of obesity if applicable. Primary outcomes included small for gestational age neonates, large for gestational age neonates, preeclampsia, and gestational diabetes mellitus. Secondary outcomes included cesarean delivery, preterm birth, postpartum weight retention, and composite neonatal morbidity. A meta-analysis of univariate and adjusted multivariate analysis studies was conducted. The random-effect model was used to pool the mean differences or odds ratios and the corresponding 95% confidence intervals. Heterogeneity was assessed using the I2 value. The Newcastle-Ottawa Scale was used to assess individual study quality. RESULTS: A total of 54 studies reporting on 30,245,946 pregnancies were included of which 11,515,411 pregnancies were in the univariate analysis and 18,730,535 pregnancies were in the adjusted multivariate analysis. In the meta-analysis of univariate studies, compared with women who gained weight as recommended in the guidelines, those who gained less than the weight recommended in the guidelines had higher odds of having a small for gestational age neonate among those with obesity class I and II (odds ratio, 1.30; 95% confidence interval, 1.17-1.45; I2=0%; P<.00001; and odds ratio, 1.56; 95% confidence interval, 1.31-1.85; I2=0%; P<.00001, respectively). However, the incidence of small for gestational age neonates was below the expected limits (<10%) and was not associated with increased neonatal morbidity. Furthermore, after adjusting for covariates, that difference was not statistically significant anymore. The difference was not statistically significant for class III obesity. Following adjusted multivariate analysis, no significant differences in small for gestational age rates were noted for any classes of obesity between groups. Significantly lower odds for large for gestational age neonates were seen in the group with gestational weight gain less than the recommended guidelines among those with obesity class I, II, and III (odds ratio, 0.69; 95% confidence interval, 0.64-0.73; I2=0%; P<.00001; odds ratio, 0.68; 95% confidence interval, 0.63-0.74; I2=0%; P<.00001; and odds ratio, 0.65; 95% confidence interval, 0.57-0.75; I2=34%; P<.00001, respectively), and similar findings were seen in the adjusted multivariate analysis. Women with weight gain less than the recommended guidelines had significantly lower odds for preeclampsia among those with obesity class I, II, and III (odds ratio, 0.71; 95% confidence interval, 0.63-0.79; I2=0%; P<.00001; odds ratio, 0.82; 95% confidence interval, 0.73-0.91; I2=0%; P<.00001; and odds ratio, 0.82; 95% confidence interval, 0.70-0.94; I2=0%; P=.006, respectively), and similar findings were seen in the adjusted multivariate analysis. No significant differences were seen in gestational diabetes mellitus between groups. Regarding preterm birth, available univariate analysis studies only reported on overall obesity and mixed iatrogenic and spontaneous preterm birth showing a significant increase in the odds of preterm birth (odds ratio, 1.42; 95% confidence interval, 1.40-1.43; I2=0%; P<.00001) among women with low weight gain, whereas the adjusted multivariate studies in overall obesity and in all 3 classes showed no significant differences in preterm birth between groups. Women with low weight gain had significantly lower odds for cesarean delivery in obesity class I, II, and III (odds ratio, 0.76; 95% confidence interval, 0.72-0.81; I2=0%; P<.00001; odds ratio, 0.82; 95% confidence interval, 0.77-0.87; I2=0%; P<.00001; and odds ratio, 0.87; 95% confidence interval, 0.82-0.91; I2=0%; P<.00001, respectively), and similar findings were seen in the adjusted multivariate analysis. There was significantly lower odds for postpartum weight retention (odds ratio, 0.20; 95% confidence interval, 0.05-0.82; I2=0%; P=.03) and lower odds for composite neonatal morbidity in the overall obesity group with low gestational weight gain (odds ratio, 0.93; 95% confidence interval, 0.87-0.99; I2=19.6%; P=.04). CONCLUSION: Contrary to previous reports, the current systematic review and meta-analysis showed no significant increase in small for gestational age rates in pregnancies with weight gain below the current guidelines for all classes of maternal obesity. Furthermore, gaining less weight than recommended in the guidelines was associated with lower large for gestational age, preeclampsia, and cesarean delivery rates. Our study provides the evidence that the current recommended gestational weight gain range is high for all classes of obesity. These results provide pertinent information supporting the notion to revisit the current gestational weight gain recommendations for women with obesity and furthermore to classify them by the class of obesity rather than by an overall obesity category as is done in the current recommendations.

Comparison of effects of Empagliflozin and Linagliptin on renal function and glycaemic control: a double-blind, randomized clinical trial.

BACKGROUND: This study aimed to compare the effects of Linagliptin and Empagliflozin on renal function and glycaemic control in patients with type 2 diabetes mellitus (DM). METHOD: We conducted a randomized, double-blind, parallel trial on patients aged 30 to 80 years with type 2 DM and HbA1c ≤ 9%, regardless of background medical therapy, to compare the effects of Empagliflozin and Linagliptin on albuminuria, FBS, HbA1c, and eGFR. Participants were given the mentioned drugs for 12 weeks. Statistical analysis was performed using appropriate tests in IBM™SPSS® statistics software for windows version 24. RESULTS: In total, 60 patients participated in the study, thirty patients in each group. The mean age of participants was 56.8 (SD = 8.15) in the Empagliflozin group and 60.9 (SD = 7.22) in the Linagliptin group. Before the intervention, FBS, HbA1C, and albuminuria values were significantly higher in the Empagliflozin group than those in the Linagliptin group (P < 0.05), but there was no significant difference between groups regarding eGFR (P = 0.271). Changes in the FBS, HbA1C, and eGFR were not significantly different between groups (P > 0.05), but there was more decrease in albuminuria in the Empagliflozin group compared to the Linagliptin group (P = 0.001, Cohen's d = 0.98). CONCLUSIONS: Regardless of baseline albuminuria, eGFR, or HbA1c, Empagliflozin 10 mg daily significantly reduced albuminuria at 12 weeks compared to Linagliptin 5 mg daily in patients with type 2 diabetes. TRIAL REGISTRATION: Iranian Registry of Clinical Trials, IRCT20200722048176N1 . Registered 3 August 2020.