Bioequivalence trials for the approval of generic drugs in Saudi Arabia: a descriptive analysis of design aspects.

BACKGROUND: This retrospective analysis aimed to comprehensively review the design and regulatory aspects of bioequivalence trials submitted to the Saudi Food and Drug Authority (SFDA) since 2017. METHODS: This was a retrospective, comprehensive analysis study. The Data extracted from the SFDA bioequivalence assessment reports were analyzed for reviewing the overall design and regulatory aspects of the successful bioequivalence trials, exploring the impact of the coefficient of variation of within-subject variability (CVw) on some design aspects, and providing an in-depth assessment of bioequivalence trial submissions that were deemed insufficient in demonstrating bioequivalence. RESULTS: A total of 590 bioequivalence trials were included of which 521 demonstrated bioequivalence (440 single active pharmaceutical ingredients [APIs] and 81 fixed combinations). Most of the successful trials were for cardiovascular drugs (84 out of 521 [16.1%]), and the 2 × 2 crossover design was used in 455 (87.3%) trials. The sample size tended to increase with the increase in the CVw in trials of single APIs. Biopharmaceutics Classification System Class II and IV drugs accounted for the majority of highly variable drugs (58 out of 82 [70.7%]) in the study. Most of the 51 rejected trials were rejected due to concerns related to the study center (n = 21 [41.2%]). CONCLUSION: This comprehensive analysis provides valuable insights into the regulatory and design aspects of bioequivalence trials and can inform future research and assist in identifying opportunities for improvement in conducting bioequivalence trials in Saudi Arabia.

A Neurophysiological Evaluation of Cognitive Load during Augmented Reality Interactions in Various Industrial Maintenance and Assembly Tasks.

Augmented reality (AR) has been shown to improve productivity in industry, but its adverse effects (e.g., headaches, eye strain, nausea, and mental workload) on users warrant further investigation. The objective of this study is to investigate the effects of different instruction methods (i.e., HoloLens AR-based and paper-based instructions) and task complexity (low and high-demanding tasks) on cognitive workloads and performance. Twenty-eight healthy males with a mean age of 32.12 (SD 2.45) years were recruited in this study and were randomly divided into two groups. The first group performed the experiment using AR-based instruction, and the second group used paper-based instruction. Performance was measured using total task time (TTT). The cognitive workload was measured using the power of electroencephalograph (EEG) features and the NASA task load index (NASA TLX). The results showed that using AR instructions resulted in a reduction in maintenance times and an increase in mental workload compared to paper instructions, particularly for the more demanding tasks. With AR instruction, 0.45% and 14.94% less time was spent on low- and high-demand tasks, respectively, as compared to paper instructions. According to the EEG features, employing AR to guide employees during highly demanding maintenance tasks increased information processing, which could be linked with an increased germane cognitive load. Increased germane cognitive load means participants can better facilitate long-term knowledge and skill acquisition. These results suggested that AR is superior and recommended for highly demanding maintenance tasks since it speeds up maintenance times and increases the possibility that information is stored in long-term memory and encrypted for recalls.

State of the Art of BIM Integration with Sensing Technologies in Construction Progress Monitoring.

The necessity for automatic monitoring tools led to using 3D sensing technologies to collect accurate and precise data onsite to create an as-built model. This as-built model can be integrated with a BIM-based planned model to check the project's status based on algorithms. This article investigates the construction progress monitoring (CPM) domain, including knowledge gaps and future research direction. Synthesis literature was conducted on 3D sensing technologies in CPM depending on crucial factors, including the scanning environment, assessment level, and object recognition indicators' performance. The scanning environment is important to determine the volume of data acquired and the applications conducted in the environment. The level of assessment between as-planned and as-built models is another crucial factor that could precisely help define the knowledge gaps in this domain. The performance of object recognition indicators is an essential factor in determining the quality of studies. Qualitative and statistical analyses for the latest studies are then conducted. The qualitative analysis showed a shortage of articles performed on 5D assessment. Then, statistical analysis is conducted using a meta-analytic regression model to determine the development of the performance of object recognition indicators. The meta-analytic model presented a good sign that the performance of those indicators is effective where [p-value is = 0.0003 < 0.05]. The study is also envisaged to evaluate the collected studies in prioritizing future works from the limitations within these studies. Finally, this is the first study to address ranking studies of 3D sensing technologies in the CPM domain integrated with BIM.

Microsatellite Variation in the Most Devastating Beetle Pests (Coleoptera: Curculionidae) of Agricultural and Forest Crops.

Weevils, classified in the family Curculionidae (true weevils), constitute a group of phytophagous insects of which many species are considered significant pests of crops. Within this family, the red palm weevil (RPW), Rhynchophorus ferrugineus, has an integral role in destroying crops and has invaded all countries of the Middle East and many in North Africa, Southern Europe, Southeast Asia, Oceania, and the Caribbean Islands. Simple sequence repeats (SSRs), also termed microsatellites, have become the DNA marker technology most applied to study population structure, evolution, and genetic diversity. Although these markers have been widely examined in many mammalian and plant species, and draft genome assemblies are available for many species of true weevils, very little is yet known about SSRs in weevil genomes. Here we carried out a comparative analysis examining and comparing the relative abundance, relative density, and GC content of SSRs in previously sequenced draft genomes of nine true weevils, with an emphasis on R. ferrugineus. We also used Illumina paired-end sequencing to generate draft sequence for adult female RPW and characterized it in terms of perfect SSRs with 1-6 bp nucleotide motifs. Among weevil genomes, mono- to trinucleotide SSRs were the most frequent, and mono-, di-, and hexanucleotide SSRs exhibited the highest GC content. In these draft genomes, SSR number and genome size were significantly correlated. This work will aid our understanding of the genome architecture and evolution of Curculionidae weevils and facilitate exploring SSR molecular marker development in these species.

Comparative analysis of transposable elements provides insights into genome evolution in the genus Camelus.

BACKGROUND: Transposable elements (TEs) are common features in eukaryotic genomes that are known to affect genome evolution critically and to play roles in gene regulation. Vertebrate genomes are dominated by TEs, which can reach copy numbers in the hundreds of thousands. To date, details regarding the presence and characteristics of TEs in camelid genomes have not been made available. RESULTS: We conducted a genome-wide comparative analysis of camelid TEs, focusing on the identification of TEs and elucidation of transposition histories in four species: Camelus dromedarius, C. bactrianus, C. ferus, and Vicugna pacos. Our TE library was created using both de novo structure-based and homology-based searching strategies ( https://github.com/kacst-bioinfo-lab/TE_ideintification_pipeline ). Annotation results indicated a similar proportion of each genomes comprising TEs (35-36%). Class I LTR retrotransposons comprised 16-20% of genomes, and mostly consisted of the endogenous retroviruses (ERVs) groups ERVL, ERVL-MaLR, ERV_classI, and ERV_classII. Non-LTR elements comprised about 12% of genomes and consisted of SINEs (MIRs) and the LINE superfamilies LINE1, LINE2, L3/CR1, and RTE clades. Least represented were the Class II DNA transposons (2%), consisting of hAT-Charlie, TcMar-Tigger, and Helitron elements and comprising about 1-2% of each genome. CONCLUSIONS: The findings of the present study revealed that the distribution of transposable elements across camelid genomes is approximately similar. This investigation presents a characterization of TE content in four camelid to contribute to developing a better understanding of camelid genome architecture and evolution.

Mortality and functional outcomes of endovascular stroke therapy in the United States.

BACKGROUND: We sought to evaluate the nationwide trends in the characteristics and outcomes of for endovascular stroke therapy in contemporary practice. METHODS: We selected patients with acute ischemic stroke who underwent endovascular stroke therapy between 01 October 2015 and 30 September 2019 in a large academic consortium database. The end points of this study were (a) in-hospital mortality and functional outcomes and, (b) predictors of poor functional outcome, defined as death or discharge to hospice, or to a long-term nursing facility. RESULTS: Among the 22,193 included patients; 50.3% were females, and 66.5% were white. Mean age was 68±15 years. Poor functional outcomes occurred in 8,274 patients (37.4%), of whom 2,741 (12.4%) died in the hospital, 1,345 (6.1%) were discharged to hospice, and 4,188 (18.9%) were discharged to other long-term facilities. Most common in-hospital complications were mechanical ventilation (32.3%), intracranial hemorrhage (18.9%), and acute kidney injury (15.6%). Median total and intensive-care length-of-stay were 7 days (IQR = 4-9), and 2 days (IQR = 1-4), respectively. Median cost was $36,609 (IQR = $26,034-$54,313). In a multi-logistic regression analysis; age, hypertension, diabetes, anemia, heart failure, vascular disease, chronic pulmonary disease, renal insufficiency, Medicare/medicaid insurance, transfer from nonendovascular capable hospital, and low procedural volume independently predicted poor functional outcomes. Tissue plasminogen activator use was associated with better functional outcomes. CONCLUSION: There is a substantial growth in the performance of endovascular stroke interventions in the United States in recent years, and those were associated with favorable short-term outcomes.

Sex-specific in-hospital outcomes of transcatheter aortic valve replacement with third generation transcatheter heart valves.

BACKGROUND: Sex-based differences in transcatheter aortic valve replacement (TAVR) outcomes have been previously documented. However, whether these differences persist with contemporary third generation transcatheter heart valves (THVs) is unknown. METHODS: We utilized Vizient's clinical database/resource manager (CDB/RM™) to identify patients who underwent TAVR between January 1, 2018 and March 31, 2020 to compare in-hospital outcomes between males and females. The primary endpoint was in-hospital mortality. Secondary endpoints included key in-hospital complications, length of stay, discharge disposition, and cost. Unadjusted, propensity-score matched and risk-adjusted analyses of outcomes were performed. RESULTS: During the study period, 44,280 patients (24,842 males, 19,438 females) underwent TAVR. The primary endpoint of in-hospital mortality was higher in females than in males (1.6 vs. 1.1% p < .001) in unadjusted analysis and persisted following propensity matching (1.6 vs. 0.9%, p < .001) and multivariable logistic regression with various risk-adjustment models. In the most comprehensive model adjusting for age, race, and clinical comorbidities, female sex was associated with 34% greater odds of in-hospital death (95% CI 20-50%, p < .001). Unadjusted and risk-adjusted rates of post-TAVR stroke, vascular complication, and blood transfusion were higher in females. Moreover, females demonstrated longer hospitalizations, higher costs and reduced rates of independent discharge home. CONCLUSION: Sex-based differences in TAVR in-hospital outcomes persist in contemporary practice with third generation transcatheter heart valves. Further research is needed to assess the reasons for these observed disparities and to identify effective mitigation strategies.

Contemporary trends in the management of aortic stenosis in the USA.

AIMS: To assess the contemporary trends in aortic stenosis (AS) interventions in the USA before and after the introduction of transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: We utilized the National-Inpatient-Sample to assess temporal trends in the incidence, cost, and outcomes of AS interventions between 1 January 2003 and 31 December 2016. During the study's period, AS interventions increased from 96 to 137 per 100 000 individuals > 60 years old, P < 0.001. In-hospital expenditure on AS interventions increased from $2.28 billion in 2003 to $4.33 in 2016 P < 0.001. Among patients who underwent aortic valve replacement, the proportion of TAVI increased from 11.9% in 2012 to 43.2% in 2016 (P < 0.001). Males and Hispanics had lower proportions of TAVI compared with females and White patients. Adjusted in-hospital mortality of isolated SAVR decreased from 5.4% in 2003 to 3.3% in 2016 (P < 0.001), whereas adjusted in-hospital mortality of TAVI decreased from 4.7% in 2012 to 2.2% in 2016, P < 0.001. The incidence of new dialysis, permanent pacemaker implantation, and blood transfusion decreased after both TAVI and SAVR between 2012 and 2016. However, the rate of post-operative stroke did not significantly decrease. Length of stay and cost of hospitalization decreased after both SAVR and TAVI, although the later remained higher with TAVI. Rates of non-home discharge decreased over time after TAVI but remained stable after isolated SAVR. CONCLUSION: This nationwide survey documents the increasing incidence of AS interventions, the rising cost of modern AS care, and the paradigm shift in aortic valve replacement practice in the USA.

A Hybrid Approach for Noise Reduction in Acoustic Signal of Machining Process Using Neural Networks and ARMA Model.

Intelligent machining has become an important part of manufacturing systems because of the increased demand for productivity. Tool condition monitoring is an integral part of these systems. Airborne acoustic emission from the machining process is a vital indicator of tool health, however, it is highly affected by background noise. Reducing the background noise helps in developing a low-cost system. In this research work, a feedforward neural network is used as an adaptive filter to reduce the background noise. Acoustic signals from four different machines in the background are acquired and are introduced to a machining signal at different speeds and feed-rates at a constant depth of cut. These four machines are a three-axis milling machine, a four-axis mini-milling machine, a variable speed DC motor, and a grinding machine. The backpropagation neural network shows an accuracy of 75.82% in classifying the background noise. To reconstruct the filtered signal, a novel autoregressive moving average (ARMA)-based algorithm is proposed. An average increase of 71.3% in signal-to-noise ratio (SNR) is found before and after signal reconstruction. The proposed technique shows promising results for signal reconstruction for the machining process.

Temporal trends in the utilization and outcomes of percutaneous coronary interventions in patients with liver cirrhosis.

OBJECTIVES: We sought to assess the national trends in the utilization and outcomes of percutaneous coronary interventions (PCI) in patients with cirrhosis. BACKGROUND: Contemporary data on PCI in patients with liver cirrhosis are limited. METHODS: The National-Inpatient-Sample was used to identify patients who underwent PCI between 2003 and 2016. We examined the annual PCI rate, and compared the in-hospital morbidity, mortality, resource utilization, and cost following PCI in patients with and without cirrhosis. RESULTS: A total of 8,860,178 PCI hospitalizations were identified, of those, 20,339 (0.2%) were performed in patients with cirrhosis. Annual PCI rates decreased overtime in patients without liver cirrhosis but increased in those with cirrhosis (Ptrend < .001). Patients with cirrhosis had a characteristic clinical, demographic, and socioeconomic profile compared with those without cirrhosis. The use of bare-metal stents decreased from 69.1 to 11.4% in the noncirrhosis group, and from 81.9 to 21.3% in the cirrhosis group. Compared with propensity-matched patients without cirrhosis, PCI in cirrhotic patients was associated with higher in-hospital mortality across all indications (STEMI 19.1 vs. 11.5%, p = .002; NSTEMI 8.7 vs. 5.6%, p = .002; and UA/SIHD 7.7 vs. 4.3%, p < .001). Cirrhotic patients also had significantly higher rates of acute kidney injury, but similar rates of vascular complications and stroke. Additionally, cirrhotic patients had longer hospitalizations, were less likely to be discharged home, and accrued higher cost across all PCI indications. CONCLUSIONS: Patients with cirrhosis who are deemed "suitable PCI candidates" in current practice remain at high-risk for worse short-term morbidity and mortality, and higher cost of care.

Incidence, Characteristics, and Outcomes of Acute Myocardial Infarction among Patients Admitted with Acute Exacerbation of Chronic Obstructive Lung Disease.

The frequency, characteristics and outcomes of acute myocardial infarction (AMI) during exacerbation of chronic obstructive pulmonary disease (COPD) are unknown. Adult patients hospitalized with a principle diagnosis of acute COPD exacerbation were identified using retrospective analysis of the Nationwide Inpatient Sample (NIS) from 2003 to 2016. Patients were stratified into 2-groups with and without a secondary diagnosis of AMI. The study's endpoints were in-hospital morbidity, mortality, and resource utilization. We also assessed the impact of invasive management strategy on the same end-points. We included 6 894 712 hospitalizations, of which 56 515 (0.82%) were complicated with AMIs. Patients with AMI were older, and had higher prevalence of known coronary disease (48.9% vs. 27.4%), atrial fibrillation (23.3% vs. 15.2%), heart failure (47.8% vs. 26.2%), and anemia (20.7% vs. 14.8%) (p < 0.001). Rates of oxygen dependence were similar (16.3% vs. 16.1%, p = 0.24). In 56 486 propensity-matched pairs of patients with and without AMI, mortality was higher in the AMI group (12.1% vs. 2.1%, p < 0.001). Rates of major morbidities, non-home discharge, and cost were all higher in the AMI group. A minority (18.1%) of patients with AMI underwent invasive assessment, and those had lower in-hospital mortality before (4.9% vs. 13.8%) and after (5.0% vs. 10.0%) propensity-score matching (p < 0.001). This lower mortality persisted in a sensitivity analysis accounting for immortal time bias. AMI complicates ∼1% of patients admitted with acute COPD exacerbation, and those have worse outcomes than those without AMI. Invasive management for secondary AMI during acute COPD exacerbation may be associated with improved outcomes but is utilized in <20% of patients.

Incidence and outcomes of early percutaneous coronary intervention after isolated valve surgery.

BACKGROUND: Coronary ischemia requiring early percutaneous coronary intervention (PCI) is a rare but serious complication of isolated valve surgery. We sought of assess the incidence, predictors and outcomes of early PCI after isolated valve surgery using the national inpatient sample. METHODS: Patients who underwent isolated aortic valve replacement (AVR), isolated mitral valve repair (MVr) or replacement (MVR) between 2003 and 2014 were identified. Patients who had early postoperative PCI were compared with patients who did not require PCI. Primary end point was in-hospital mortality. Secondary endpoints were complications, length-of-stay and cost. RESULTS: Among the 135,611 included patients, 1,074 (0.8%) underwent PCI prior to discharge. Unadjusted in-hospital mortality was higher in patients requiring early PCI following AVR (11.2 vs. 3.1%), MVR (24.1 vs. 5.5%), and MVr (22.4 vs. 2.5%) (P < 0.001) compared with patients not requiring PCI. Postoperative PCI remained independently associated with higher mortality after adjusting for demographics, comorbidities and hospital characteristics (adjusted OR [aOR] = 3.74, 95%CI 2.70-5.17 for AVR, aOR = 6.10, 95%CI 4.53-8.23 for MVR, and aOR = 9.90, 95%CI 7.22-13.58 for MVr). Patients undergoing PCI had higher incidences of stroke, acute kidney injury, infectious complications, higher hospital charges, and longer hospitalizations. Age, robotic-assisted surgery, and chronic renal failure were independent predictors of needing early postoperative PCI. CONCLUSIONS: Early PCI after isolated aortic or mitral valve surgery is rare but is associated with substantial in-hospital morbidity, mortality, and cost. Further studies are needed to identify preventable causes, and optimal management strategies of this serious complication.

Meta-Analysis Comparing Renal Outcomes after Transcatheter versus Surgical Aortic Valve Replacement.

BACKGROUND: Acute kidney injury (AKI) is a common complication of aortic valve replacement. However, comparative on the incidence of (AKI) following transcatheter (TAVR) versus surgical valve replacement (SAVR) is sparse. METHODS: We performed a meta-analysis of the randomized controlled trials (RCT) and propensity-matched observational studies comparing (A) incidence of AKI and (B) incidence of dialysis-requiring AKI at 30 days after TAVR and SAVR. RESULTS: Twenty-six studies (20 propensity-matched studies; 6 RCTs) including 19,954 patients were analyzed. The incidence of AKI was lower after TAVR than after SAVR (7.1% vs. 12.1%, OR 0.52; 95%CI, 0.39-0.68; p<0.001, I2=57%), but the incidence of dialysis-requiring AKI was similar (2.8% vs. 4.1%, OR 0.78; 95%CI, 0.49-1.25; p=0.31, I2=70%). Similar results were observed in a sensitivity analysis including RCTs only for both AKI ([5 RCTs; 5,418 patients], 2.0% vs. 5.0%, OR 0.39; 95%CI, 0.28-0.53; p<0.001, I2=0%), and dialysis-requiring AKI ([2 RCTs; 769 patients]; 2.9% vs. 2.6%, OR 1.1; 95%CI, 0.47-2.58; p=0.83, I2=0%). However, in studies including low-intermediate risk patients only, TAVR was associated with lower incidence of AKI ([10 studies; 6,510 patients], 7.6% vs. 12.4%, OR 0.55, 95%CI 0.39-0.77, p<0.001, I2=57%), and dialysis-requiring AKI, ([10 studies; 12,034 patients], 2.0% vs. 3.6%, OR 0.57, 95%CI 0.38-0.85, p=0.005, I2=23%). CONCLUSIONS: TAVR is associated with better renal outcomes at 30 days in comparison with SAVR, especially in patients at low-intermediate surgical risk. Further studies are needed to assess the impact of AKI on long-term outcomes of patients undergoing TAVR and SAVR.

Association between surgical volume and clinical outcomes following coronary artery bypass grafting in contemporary practice.

BACKGROUND: Studies assessing the association between surgical volume and coronary artery bypass grafting (CABG) outcomes yielded conflicting results. Given the substantial recent decrease in CABG volume, we sough to examine the volume-outcomes effect in contemporary practice. METHODS: The National Readmission Database was queried to identify patients undergoing CABG between January 1, 2015 and December 31, 2016. Risk-adjusted in-hospital morbidity, mortality, length-of-stay, cost, and 30-day readmission were compared between low-, intermediate-, and high-volume centers. RESULTS: A total of 411 159 CABG hospitalizations at 1558 hospitals were included. Hospitals were classified into three tertiles (high > 250, intermediate 100-250, and low-volume < 100). Hospitals in the highest tertile (n = 568) performed 73.9% of all CABG operations, while those in the intermediate (n = 452), and low (n = 538) volume tertiles performed only 21.7% and 4.4% of all CABGs, respectively. The median number of CABGs performed at high-, intermediate-, and low-volume hospitals was 45 316 335, respectively. After risk adjustment, undergoing CABG at low- or intermediate- volume hospital (vs high-volume hospitals) was associated with higher in-hospital death (odd ratio [OR] = 1.31, 95% confidence interval [CI], 1.19-1.44, and OR = 1.11, 95% CI, 1.05-1.17, respectively, P < .001). Similarly, adjusted odds of stroke, acute kidney injury, and blood transfusion were higher at low- and intermediate-volume centers compared with high-volume centers. Undergoing CABG at a low-volume center was associated with 50% higher adjusted cost and 77% higher adjusted 30-day readmissions. CONCLUSIONS: In contemporary practice, in which one-third of CABG-capable hospitals perform < 100 CABG operations annually, a strong relationship is observed between surgical volume and adjusted in-hospital morbidity, mortality, cost, and 30-day readmission.

Contemporary trends and outcomes of mitral valve surgery for infective endocarditis.

BACKGROUND: Contemporary data on mitral valve (MV) surgery in patients with infective endocarditis (IE) are limited. METHODS: The National Inpatient Sample was queried to identify patients with IE who underwent MV surgery between 2003 and 2016. We assessed (a) temporal trends in the incidence of MV surgery for IE, (b) morbidity, mortality, and cost of MV repair vs replacement, and (c) predictors of in-hospital mortality. RESULTS: The proportion of MV operations involving patients with IE increased from 5.4% in 2003 to 7.3%, and the proportion of MV repair among those undergoing surgery for IE increased from 15.2% to 25.0% (Ptrend < .001). In-hospital mortality was higher in the replacement group (11.3% vs 8.1%; P < .001), and this excess mortality persisted after propensity score matching (11.2% vs 8.1%; P < .001), and in sensitivity analyses excluding concomitant surgery (unadjusted 11.3% vs 4.8%; adjusted 8.5% vs 4.5%; P < .001), and stratifying patients by the time of operation (within 7 days, 11.3% vs 6.8%; P < .001 and >7 days, 11.9% vs 9.1%; P = .012). In the propensity-matched cohorts, shock and need for tracheostomy were more frequent in the replacement group, but rates of stroke, pacemaker implantation, new dialysis, and blood transfusion were similar. Mitral valve repair was, however, associated with shorter hospitalizations, more home discharges, and less cost. In a multivariate regression analysis, age above 70 and chronic dialysis were the strongest predictors of in-hospital mortality. CONCLUSION: Mitral valve repair in IE patients is associated with lower in-hospital mortality, resource utilization, and cost compared with MV replacement.

Comparative outcomes of transcatheter aortic valve replacement in African American and Caucasian patients with severe aortic stenosis.

BACKGROUND: Racial disparities in cardiovascular care have been extensively investigated. The introduction of transcatheter aortic valve replacement (TAVR) revolutionized the treatment of aortic stenosis (AS) in the last decade. Whether a racial disparity in the utilization and outcome of TAVR exists is unknown. METHODS: We utilized the nationwide inpatient sample (NIS) to compare utilization rates, and in-hospital outcomes of Caucasians and African American (AA) patients who underwent TAVR between August 2011 and December 2014. RESULTS: A total of 7,176 patients (6870 Caucasians, 95.7%) and (306 AAs, 4.3%) were included in this analysis. Among patients who underwent aortic valve replacement between 2011 and 2014, the rates of TAVR utilization increased from 0.32% to 7.6% in AAs and from 0.4% to 8.8% in Caucasians. In propensity-matched cohorts of patients (n = 300 Caucasians and n = 300 AAs), in-hospital mortality was similar (3.7% and 3.3%, respectively, P = 0.99). Also, rates of key complications including stroke, permanent pacemaker implantation (PPMI), vascular complications, acute kidney injury, new dialysis, blood transfusion, and tamponade were similar in both races. There was also no significant difference between Caucasians and AAs with regards to length of stay, cost of hospitalization, and intermediate care facility utilization. CONCLUSIONS: There was no significant difference in the utilization rates, in-hospital outcomes, and cost of TAVR between Caucasians and AA patients in contemporary US practice. Further comparative studies of surgical and TAVR in AAs and other racial minorities are warranted.

Trends and predictors of implantable cardioverter defibrillator implantation after sudden cardiac arrest: Insight from the national inpatient sample.

BACKGROUND: Implantable cardioverter defibrillator (ICD) has a class IA indication in survivors of sudden cardiac arrest (SCA) provided no reversible cause is identified. We sought to determine trends and predictors of ICD implant in SCA patients from a national sample of the United States population. METHODS AND RESULTS: Data were gathered from National Inpatient Sample (NIS) from January 2003 to December 2014. All patients ≥18 years of age with a primary discharge diagnosis of SCA, ventricular fibrillation (VF), ventricular flutter, and ventricular tachycardia (VT) were included. Patients died during hospitalization, had a previous ICD implant, and with a reversible cause of SCA were excluded. Primary outcome of interest was rate of new ICD implant at discharge. Logistic regression analysis was then performed to determine predictors for ICD implantation. A total of 176,876 patients were identified to have SCA, VF, ventricular flutter, and VT. After applying exclusion criteria, we were left with 22,054 patients. Out of this, 6,908 (31%) patients were implanted with an ICD prior to discharge. There was a linear trend toward reduced ICD utilization over our study period (40% in 2003 vs 25% in 2014, P trend = 0.0004). Advanced age, black race, and chronic renal disease are independently associated with low ICD utilization. CONCLUSION: We found low trend of ICD implant in survivors of SCA without any reversible cause. There is a need to identify etiologies behind low ICD utilization in this vulnerable group who are at most risk for a subsequent SCA.

Sudden cardiac arrest in end-stage renal disease patients on dialysis: A nationwide study.

BACKGROUND: Sudden cardiac arrest (SCA) is frequently encountered in end-stage renal disease (ESRD) patients on dialysis. There is a dearth of national data on SCA-associated outcomes in this specific patient population. The aim of the present study is to study these parameters from a nationally representative US population. METHODS: Data were extracted from National Inpatient Sample database from October 2005 to December 2014. All patients with clinical encounter of dialysis during the study period were enrolled. Patients who underwent SCA, ventricular fibrillation, ventricular tachycardia, and ventricular flutter were then identified by applying relevant International Classification of Diseases, Ninth Revision, Clinical Modification codes. Patients with acute kidney injury and prior renal transplant were excluded. Propensity matching was done to balance covariates among study groups. Logistic regression analysis was done to assess for predictors of SCA-associated mortality in ESRD patients on dialysis. RESULTS: A total of 1 147 760 patients were included in the final analyses. Patients who suffered SCA were older when compared to the non-SCA cohort and had a higher burden of comorbidities. About half (52.10%) of ESRD patients who suffered SCA died. Advanced age, metabolic acidosis, and cardiogenic shock were independently associated with reduced survival after SCA. New implantable cardioverter defibrillator implantation continues to be low in this patient population at discharge. CONCLUSION: SCA in settings of ESRD on dialysis carries high mortality and frequent morbidity. Further research in therapeutic interventions that could prevent SCA in this vulnerable population is utmost needed.

Incidence and Outcomes of Myocardial Infarction in Patients Admitted With Acute Ischemic Stroke.

BACKGROUND AND PURPOSE: Data on the incidence and outcomes of acute myocardial infarction (AMI) complicating acute ischemic stroke (AIS) are limited. We aim to evaluate the incidence, treatment patterns, and outcomes of AMI in patients with AIS using a nationwide database. METHODS: The National Inpatient Sample was used to identify patient with AIS between 2003 and 2014. Trends of incidence of AMI and its associated in-hospital mortality were evaluated. Univariate and multivariate logistic regressions were used to evaluate predictors of AMI. The impact of AMI on in-hospital outcomes was assessed in a comparative analysis of propensity-matched groups of patients with and without AMI. RESULTS: Patients with AIS (n=864 043) were identified in the national inpatient sample, of whom 13 573 patients (1.6%) had an AMI (79.5% non-ST-segment-elevation myocardial infarction and 20.5% ST-segment-elevation myocardial infarction). In-hospital mortality was 21.4% and 7.1% in propensity-matched cohorts of patients with and without AMI, P<0.001. In-hospital length of stay and cost of care were 50% higher in the AMI group. In a multivariate logistical regression analysis, the strongest predictors of having AMI after AIS were older age, history of coronary artery disease, chronic renal insufficiency, undergoing mechanical thrombectomy, and rhythm and conduction abnormalities. In the AMI group, undergoing coronary angiography and undergoing percutaneous coronary intervention both strongly correlated with lower in-hospital mortality (odds ratio, 0.34 [confidence interval, 0.23-0.51] and 0.26 [confidence interval, 0.20-0.34], respectively, P<0.001). However, these were only performed in 7.5% and 2% of patients, respectively. CONCLUSIONS: AMI complicating stroke carries a substantial in-hospital mortality and cost of care. Patients who underwent coronary angiography with or without intervention may have improved survival although it was only utilized in a minority of patients. Further studies needed to discern the ideal approach in AMI in patients with AIS.

Intracardiac versus transesophageal echocardiography to guide transcatheter closure of interatrial communications: Nationwide trend and comparative analysis.

OBJECTIVES: This study aimed to assess current temporal trends in utilization of ICE versus TEE guided closure of interatrial communications, and to compare periprocedural complications and resource utilization between the two imaging modalities. BACKGROUND: While transesophageal echocardiography (TEE) has historically been used to guide percutaneous structural heart interventions, intracardiac echocardiography (ICE) is being increasingly utilized to guide many of these procedures such as closure of interatrial communications. METHODS: Using the Nationwide Inpatient Sample, all patients aged >18 years, who underwent ASD or PFO closure with either ICE or TEE guidance between 2003 and 2014 were included. Comparative analysis of outcomes and resource utilization was performed using a propensity score-matching model. RESULTS: ICE guidance for interatrial communication closure increased from 9.7% in 2003 to 50.6% in 2014. In the matched model, the primary endpoint of major adverse cardiovascular events occurred less frequently in the ICE group versus the TEE group (11.1% vs 14.3%, respectively, P = 0.008), mainly driven by less vascular complications in the ICE group (0.5% vs 1.3%, P = 0.045). Length of stay was shorter in the ICE group (3 ± 4 vs 4 ± 4 days, P < 0.0001). Cost was similar in the two groups 18 454 ± 17 035$ in the TEE group vs 18 278 ± 15 780$ in the ICE group (P = 0.75). CONCLUSIONS: Intracardiac echocardiogram utilization to guide closure of interatrial communications has plateaued after a rapid rise throughout the 2000s. When utilized to guide interatrial communication closure procedure, ICE is as safe as TEE and does not increase cost or prolonged hospitalizations.