Stability-Indicating TLC-Densitometric and HPLC Methods for Simultaneous Determination of Teneligliptin and Pioglitazone in Pharmaceutical Dosage Forms with Eco-Friendly Assessment.

The combination of teneligliptin hydrobromide hydrate and pioglitazone hydrochloride in pharmaceutical formulations has improved type 2 diabetes management. Two chromatographic methods TLC-densitometry and RP-HPLC were developed for simultaneous quantification of teneligliptin hydrobromide hydrate and pioglitazone hydrochloride in pharmaceutical formulations, ensuring accuracy and stability assessment. The TLC method uses a mobile phase of methanol, toluene, ethyl acetate and triethylamine (1:7:2:0.1, v/v/v/v) on TLC silica gel plates, scanned at 268 nm. The RP-HPLC method employs isocratic elution with acetonitrile and sodium acetate buffer (adjust pH 3.6 with glacial acetic acid, 60:40 v/v) on a shimpack C18 column (250 × 4.6 mm i.d., 5 µm), detected at 235 nm. Both methods offer high accuracy and reliability, making them valuable for pharmaceutical quality control. Additionally, an environmental impact assessment was conducted using eco-scale, Analytical Greenness Metric Approach, Green Analytical Procedure Index, and national environmental method index to evaluate solvent consumption, waste generation and energy usage. Statistical comparisons (t-tests and F-tests) validate the outcomes of both methods, ensuring their effectiveness in drug formulation analysis. These methods can enhance pharmaceutical quality control while fulfilling environmental responsibilities.

Novel strategy: Identifying new markers for demyelination in diabetic distal symmetrical polyneuropathy.

Objective: To develop a novel strategy for identifying acquired demyelination in diabetic distal symmetrical polyneuropathy (DSP). Background: Motor nerve conduction velocity (CV) slowing in diabetic DSP exceeds expectations for pure axonal loss thus implicating superimposed acquired demyelination. Methods: After establishing demyelination confidence intervals by regression analysis of nerve conduction data from chronic inflammatory demyelinating polyneuropathy (CIDP), we prospectively studied CV slowing in 90 diabetic DSP patients with and without at least one motor nerve exhibiting CV slowing (groups A and B) into the demyelination range by American Academy of Neurology (AAN) criteria respectively and 95 amyotrophic lateral sclerosis (ALS) patients. Simultaneously, secretory phospholipase A2 (sPLA2) activity was assessed in both diabetic groups and 46 healthy controls. Results: No ALS patient exhibited CV slowing in more than two motor nerves based on AAN criteria or the confidence intervals. Group A demonstrated a significantly higher percentage of patients as compared to group B fulfilling the above criteria, with an additional criterion of at least one motor nerve exhibiting CV slowing in the demyelinating range and a corresponding F response in the demyelinating range by AAN criteria (70.3 % vs. 1.9 %; p < 0.0001). Urine sPLA2 activity was increased significantly in diabetic groups as compared to healthy controls (942.9 ± 978.0 vs. 591.6 ± 390.2 pmol/min/ml, p < 0.05), and in group A compared to Group B (1328.3 ± 1274.2 vs. 673.8 ± 576.9 pmol/min/ml, p < 0.01). More patients with elevated sPLA2 activity and more than 2 motor nerves with CV slowing in the AAN or the confidence intervals were identified in group A as compared to group B (35.1 % vs. 5.7 %, p < 0.001). Furthermore, 13.5 % of patients in diabetic DSP Group A, and no patients in diabetic DSP Group B, fulfilled an additional criterion of more than one motor nerve with CV slowing into the demyelinating range with its corresponding F response into the demyelinating range by AAN criteria. Conclusion: A combination of regression analysis of electrodiagnostic data and a urine biological marker of systemic inflammation identifies a subgroup of diabetic DSP with superimposed acquired demyelination that may respond favorably to immunomodulatory therapy.

Composite Plot for Visualizing Aminotransferase and Bilirubin Changes in Clinical Trials of Subjects with Abnormal Baseline Values.

INTRODUCTION: On-treatment excursions of liver laboratory test values in clinical trials involving subjects with underlying liver disease are relevant for the efficacy and safety assessment of drug products and biologics. Existing visualization and analysis tools do not efficiently provide an integrated view of these excursions when baseline liver tests are abnormal. OBJECTIVE: The aim of this study was to develop a composite plot that enables visualization of on-treatment changes in liver test results both as multiples of the upper limit of normal defined by each laboratory's reference population (×ULN) and multiples of the subjects' baseline (×BLN) values. METHODS: The composite plot approach combines biochemical evaluation for drug-induced severe hepatotoxicity (eDISH) plots sequentially applied to subjects' baseline and peak on-treatment liver test results normalized by ULN and integrates them into a four-panel shift plot of peak on-treatment values normalized by BLN. RESULTS: The composite plot enabled efficient assessment of improvement in liver test values during treatment compared with pretreatment in subjects treated with the investigational drug (or the natural history of placebo-treated subjects) and identified outlier subjects for potential drug-induced liver injury. CONCLUSION: For studies in subjects with abnormal baseline values, the composite plot has potential application in the assessment of beneficial and concerning on-treatment modifications in liver test values in reference to the individual subject's baseline and population threshold values.

An Evaluation of Medical Students' Perceptions, Knowledge, and Attitudes About People With Disability After Attending the Learning Session on Disability Competency: A Cross-Sectional Study.

Background and objective The Medical Council of India [now replaced by the National Medical Commission (NMC)] has implemented a new competency-based curriculum for medical education. Eight competencies in the curriculum are related to the principles of disability-inclusive compassionate care. This study aimed to evaluate the knowledge, perceptions, and attitudes among undergraduate medical students about people with disability after attending learning sessions on disability competency. Materials and methods After they attended the learning session during the foundation course, participants were evaluated by using a questionnaire involving 26 questions, of which 17 were based on the Likert scale to assess general perceptions towards the person with a disability, while three questions aimed to assess attitudes, and six closed-ended questions tried to assess knowledge about disability. Results In the present study, 79.7% (n=157) of the students thought that people with disabilities faced problems getting involved in society, and 81.2% (n=160) felt that it was harder for them to make friends than others. The majority of the students disagreed with the idea that people with disabilities are a burden on society (n=149, 75.6%) or their families (n=119, 60.4%); 65% (n=128) of the students thought that people with disabilities are more determined than others to reach their goals and achieve more owing to their disability (n=104, 52.85%). A total of 161 (81.7%) students disagreed with the statement that people with disabilities should not be optimistic about their future. A comparison of the pre- and post-test data revealed that students' knowledge regarding disability increased and they gained a more positive attitude towards people with a disability after attending teaching and learning sessions (p<0.0001). Conclusion Our findings showed a significant improvement in the undergraduate medical students' understanding and empathy toward individuals with disabilities following sessions on disability competency. Teaching and learning sessions on disability competencies for newly admitted students in medical school can sensitize, orient, increase knowledge, and develop positive attitudes toward people with disabilities. Further studies on the topic are needed involving different phases of clinical teaching.

CXCL9/10-engineered dendritic cells promote T cell activation and enhance immune checkpoint blockade for lung cancer.

Immune checkpoint blockade (ICB) with PD-1/PD-L1 inhibition has revolutionized the treatment of non-small cell lung cancer (NSCLC). Durable responses, however, are observed only in a subpopulation of patients. Defective antigen presentation and an immunosuppressive tumor microenvironment (TME) can lead to deficient T cell recruitment and ICB resistance. We evaluate intratumoral (IT) vaccination with CXCL9- and CXCL10-engineered dendritic cells (CXCL9/10-DC) as a strategy to overcome resistance. IT CXCL9/10-DC leads to enhanced T cell infiltration and activation in the TME and tumor inhibition in murine NSCLC models. The antitumor efficacy of IT CXCL9/10-DC is dependent on CD4+ and CD8+ T cells, as well as CXCR3-dependent T cell trafficking from the lymph node. IT CXCL9/10-DC, in combination with ICB, overcomes resistance and establishes systemic tumor-specific immunity in murine models. These studies provide a mechanistic understanding of CXCL9/10-DC-mediated host immune activation and support clinical translation of IT CXCL9/10-DC to augment ICB efficacy in NSCLC.

Trans-nasal sphenopalatine ganglion block for post-dural puncture headache management: a meta-analysis of randomized trials

Abstract Objective: To evaluate the efficacy and safety of trans-nasal Sphenopalatine Ganglion (SPG) block over other treatments for Post-Dural Puncture Headache (PDPH) management. Methods: A systematic literature search was conducted on databases for Randomized Controlled Trials (RCTs) comparing trans-nasal SPG blockade for the management of PDPH over other treatment modalities. All outcomes were pooled using the Mantel-Haenszel method and random effect model. Analyses of all outcomes were performed as a subgroup based on the type of control interventions (conservative, intranasal lignocaine puffs, sham, and Greater Occipital Nerve [GON] block). The quality of evidence was assessed using the GRADE approach. Results: After screening 1748 relevant articles, 9 RCTs comparing SPG block with other interventions (6 conservative treatments, 1 sham, 1 GON and 1 intranasal lidocaine puff) were included in this meta-analysis. SPG block demonstrated superiority over conservative treatment in pain reduction at 30 min, 1 h, 2 h, 4 h after interventions and treatment failures with "very low" to "moderate" quality of evidence. The SPG block failed to demonstrate superiority over conservative treatment in pain reduction beyond 6 h, need for rescue treatment, and adverse events. SPG block demonstrated superiority over intranasal lignocaine puff in pain reduction at 30 min, 1 h, 6 h, and 24 h after interventions. SPG block did not show superiority or equivalence in all efficacy and safety outcomes as compared to sham and GON block. Conclusion: Very Low to moderate quality evidence suggests the superiority of SPG block over conservative treatment and lignocaine puff for short-term pain relief from PDPH. PROSPERO Registration: CRD42021291707.

Role of Selective Serotonin Reuptake Inhibitors in the Treatment of Hypochondriasis: A Systematic Review.

Hypochondriasis is a condition characterized by an unrealistic fear of having a serious medical illness resulting in health anxiety. Currently, no evidence-based pharmacological treatment options are available for the treatment of hypochondriasis. Since selective serotonin reuptake inhibitors (SSRIs) are the first-line treatment option for anxiety disorders, they may be useful for relieving hypochondriasis symptoms. Moreover, off-label use of SSRIs in these cases is highly prevalent in clinical practice. Thus, in this study, we aimed to review the available literature to assess the role of SSRIs in the treatment of hypochondriacal symptoms. A systematic search was conducted in PubMed, Scopus, ScienceDirect, Embase, and Cochrane Database of Systematic Reviews from the date of inception to December 2022. We included only randomized clinical trials (RCTs) investigating the effect of SSRIs in the treatment of hypochondriacal symptoms. Non-RCTs, observation studies, and animal studies were excluded. The Risk of Bias 2 tool was used to assess the quality of included studies. Out of 2264 articles, six RCTs met our inclusion criteria. Studies have been conducted using different SSRIs in the treatment of primary hypochondriasis and hypochondriacal symptoms associated with other psychiatric disorders. All the studies have found that the use of SSRIs has some beneficial role in improving hypochondriacal symptoms. This suggests that SSRIs may be one of the promising pharmacological interventions in the treatment of hypochondriasis.

Impact of real-time optical coherence tomography and angiographic coregistration on the percutaneous coronary intervention strategy.

Background: The use of optical coherence tomography (OCT) with angiographic coregistration (ACR) during percutaneous coronary intervention (PCI) for procedural decision-making is evolving; however, large-scale data in real-world practice are lacking. Aims: Our study aims to evaluate the real-time impact of OCT-ACR on clinician decision-making during PCI. Methods: Patients with angiographic diameter stenosis >70% in at least one native coronary artery were enrolled in the study. The pre- and post-PCI procedural strategies were prospectively assessed after angiography, OCT, and ACR. Results: A total of 500 patients were enrolled in the study between November 2018 and March 2020. Among these, data related to 472 patients with 483 lesions were considered for analysis. Preprocedural OCT resulted in a change in PCI strategy in 80% of lesions: lesion preparation (25%), stent length (53%), stent diameter (36%), and device landing zone (61%). ACR additionally impacted the treatment strategy in 34% of lesions. Postprocedural OCT demonstrated underexpansion (15%), malapposition (14%), and tissue/thrombus prolapse (7%), thereby requiring further interventions in 30% of lesions. No further change in strategy was observed with subsequent postprocedural ACR. Angiographic and procedural success was achieved in 100% of patients, and the overall incidence of major adverse cardiovascular events at 1 year was 0.85%. Conclusions: The outcomes reflect the real-time impact of OCT-ACR on the overall procedural strategy in patients undergoing PCI. ACR had a significant impact on the treatment strategy and was associated with better clinical outcomes at 1 year after index PCI. OCT-ACR has become a practical tool for improving outcomes in patients with complex lesions.

Trans-nasal sphenopalatine ganglion block for post-dural puncture headache management: a meta-analysis of randomized trials.

OBJECTIVE: To evaluate the efficacy and safety of trans-nasal Sphenopalatine Ganglion (SPG) block over other treatments for Post-Dural Puncture Headache (PDPH) management. METHODS: A systematic literature search was conducted on databases for Randomized Controlled Trials (RCTs) comparing trans-nasal SPG blockade for the management of PDPH over other treatment modalities. All outcomes were pooled using the Mantel-Haenszel method and random effect model. Analyses of all outcomes were performed as a subgroup based on the type of control interventions (conservative, intranasal lignocaine puffs, sham, and Greater Occipital Nerve [GON] block). The quality of evidence was assessed using the GRADE approach. RESULTS: After screening 1748 relevant articles, 9 RCTs comparing SPG block with other interventions (6 conservative treatments, 1 sham, 1 GON and 1 intranasal lidocaine puff) were included in this meta-analysis. SPG block demonstrated superiority over conservative treatment in pain reduction at 30 min, 1 h, 2 h, 4 h after interventions and treatment failures with "very low" to "moderate" quality of evidence. The SPG block failed to demonstrate superiority over conservative treatment in pain reduction beyond 6 h, need for rescue treatment, and adverse events. SPG block demonstrated superiority over intranasal lignocaine puff in pain reduction at 30 min, 1 h, 6 h, and 24 h after interventions. SPG block did not show superiority or equivalence in all efficacy and safety outcomes as compared to sham and GON block. CONCLUSION: Very Low to moderate quality evidence suggests the superiority of SPG block over conservative treatment and lignocaine puff for short-term pain relief from PDPH. PROSPERO REGISTRATION: CRD42021291707.

Electrodiagnostic profile of conduction slowing in amyotrophic lateral sclerosis.

Objective: Since motor nerve conduction slowing can occur due to loss of large axons, we investigate the conduction slowing profile in amyotrophic lateral sclerosis (ALS) and identify the limits beyond which the diagnosis of exclusive axonal loss is unlikely. Methods: First, using linear regression analysis, we established the range of motor conduction slowing in 76 chronic inflammatory demyelinating polyneuropathy (CIDP) patients. Demyelinating range confidence intervals were defined by assessing conduction velocity (CV), distal latency (DML), and F-wave latency (F) in relation to distal compound muscle action potential (CMAP) amplitude of median, ulnar, fibular, and tibial nerves. Results were subsequently validated in 38 additional CIDP patients. Then, the newly established demyelination confidence intervals were used to investigate the profile of conduction slowing in 95 ALS patients. Results: CV slowing, prolonged DML, and abnormal F were observed in 22.2%, 19.6%, and 47.1% of the studied nerves respectively in ALS patients. When slowing occurred, it affected more than one segment of the motor nerve, suggesting that CMAP amplitude dependent conduction slowing caused by an exclusive loss of large axons is the main mechanism of slowing. No ALS patient had more than 2 nerves with CV slowing in the confidence interval defined by the regression equations or the American Academy of Neurology (AAN) research criteria for CIDP diagnosis. Conclusions: The presence of more than two motor nerves with CV slowing in the demyelinating range defined by the regression analysis or AAN criteria in ALS patients suggests the contribution of acquired demyelination or other additional mechanisms exist in the electrodiagnostic profile of ALS.

Suspected cutaneous adverse drug reactions reported with traditional medicines: analysis of data for United Nations Asia region from WHO VigiBase.

Background: Data on traditional medicine-induced cutaneous adverse drug reactions (ADRs) is very scarce. The current secondary analysis based on the WHO database (VigiBase) of individual case safety reports (ICSRs) focuses on the suspected cutaneous ADRs linked to traditional medicines (TMs). Methods: All the ICSRs reported between 1st January 2016 and 30th June 2021 from the UN Asia region in VigiBase where at least one TM was suspected to cause cutaneous ADRs were included in the study. Data regarding demographic details, suspected drug, adverse reaction as per MedDRA term, the seriousness of the reaction, de-challenge, re-challenge, and clinical outcome for suspected cutaneous ADRs associated with TM were obtained from VigiBase and analyzed for frequency of reported events and suspected medicines. Findings: Total 3,523 ICSRs with 5,761 ADRs related to "skin and subcutaneous tissue disorders" were included in the analysis. Amongst these, 6.8% of ICSRs were reported as serious. Pruritus (29.6%), rash (20.3%), urticaria (18.9%), and hyperhidrosis (3.3%) were commonly reported ADRs. Artemisia argyi H.Lév. and Vaniot. (14.9%), Ginkgo biloba L. (5.1%), Vitis vinifera L. (4%), Vitex agnus-castus L. (3.8%), Silybum marianum (L.), Gaertn (3.5%), and Viscus album L. (2.7%) were some commonly suspected TMs for cutaneous ADRs. There were 46 cases of Stevens-Johnson syndrome and toxic epidermal necrolysis reported with TMs during the study period. Death was reported in 5 ICSRs. Interpretation: TMs are linked with various cutaneous ADRS ranging from pruritus to toxic epidermal necrolysis which may have serious consequences. TMs listed as suspected offending agents in this analysis, should be kept in mind while dealing with suspected cutaneous ADRs. Clinicians should be more vigilant in detecting and reporting events associated with TMs.

Safety of Prepping the External Fixator In Situ During Staged Internal Fixation of Pilon Fractures: A Retrospective Comparative Cohort Study.

OBJECTIVE: (1) To assess the rate of fracture-related infection (FRI) and unplanned reoperation of disinfecting and prepping in the external fixator (Ex-Fix) instrument during definitive open reduction and internal fixation (ORIF) of pilon fractures treated by a staged protocol and (2) to determine whether the amount of time from external fixation to ORIF influences the risk of FRI. DESIGN: Retrospective cohort study. SETTING: Level 1 academic trauma center. PATIENTS: One hundred thirty-three patients who underwent operative treatment for pilon fracture between 2010 and 2020. INTERVENTION: External fixation and ORIF with or without the Ex-Fix prepped in situ during definitive fixation. MAIN OUTCOME MEASUREMENTS: FRI and unplanned reoperation rates. RESULTS: 133 patients were enrolled, of which 47 (35.3%) had Ex-Fix elements prepped in situ. There was an overall infection rate of 23.3% and unplanned reoperation rate of 11.3%, and there was no significant difference in rates between the 2 cohorts. Patients with Ex-Fix elements prepped in situ who developed an FRI had a higher rate of MRSA and MSSA . Diabetes ( P = 0.0019), open fracture ( P = 0.0014), and longer (≥30 days) interval to ORIF ( P = 0.0001) were associated with postoperative FRI. CONCLUSIONS: Prepping elements of the Ex-Fix in situ did not lead to an increase in rates of FRI or unplanned reoperation. Although diabetes and open fracture were associated with FRI risk, a stronger association was a longer interval of Ex-Fix utilization before definitive internal fixation, specifically 30 days or greater. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

SGLT2 inhibitors reduce adverse renal and CV outcomes in patients with or without diabetes.

SOURCE CITATION: Nuffield Department of Population Health Renal Studies Group; SGLT2 inhibitor Meta-Analysis Cardio-Renal Trialists' Consortium. Impact of diabetes on the effects of sodium glucose co-transporter-2 inhibitors on kidney outcomes: collaborative meta-analysis of large placebo-controlled trials. Lancet. 2022;400:1788-801. 36351458.

Coupled thermal-hemodynamics computational modeling of cryoballoon ablation for pulmonary vein isolation.

Cryoballoon ablation (CBA) is a cryo-energy based minimally invasive treatment procedure for patients suffering from left atrial (LA) fibrillation. Although this technique has proved to be effective, it is prone to reoccurrences and some serious thermal complications. Also, the factors affecting thermal distribution at the pulmonary vein-antrum junction that are critical to the treatment success is poorly understood. Computer modeling of CBA can resolve this issue and help understand the factors affecting this treatment. To do so, however, numerical challenges associated with the simulation of advection-dominant transport process must be resolved. Here, we describe the development of a thermal-hemodynamics computational framework to simulate incomplete occlusion in a patient-specific LA geometry during CBA. The modeling framework uses the finite element method to predict hemodynamics, thermal distribution, and lesion formation during CBA. An incremental pressure correction scheme is used to decouple velocity and pressure in the Navier-Stokes equation, whereas several stabilization techniques are also applied to overcome numerical instabilities. The framework was implemented using an open-source FE library (FEniCS). We show that model predictions of the hemodynamics in a realistic human LA geometry match well with measurements. The effects of cryoballoon position, pulmonary vein blood velocity and mitral regurgitation on lesion formation during CBA was investigated. For a -700C cryoballoon temperature, the model predicts lesion formation for gaps less than 2.5 mm and increasing efficiency of CBA for higher balloon tissue contact areas. The simulations also predict that lesion formation is not sensitive to variation in pulmonary vein blood velocity and mitral regurgitation. The framework can be applied to optimize CBA in patients for future clinical studies.

Clinical Diagnosis of the Infantile Shoulder Subluxation in Residual Brachial Plexus Birth Injury and Its Correlation With Ultrasound Diagnosis.

INTRODUCTION AND AIMS OF STUDY: Timely detection of shoulder subluxation in infants with brachial plexus birth injury (BPBI) is essential to prevent the progression of glenohumeral deformity. Shoulder ultrasonography (USG) is routinely used to detect an infantile subluxation/dislocation, but its use is limited because of the paucity of expert radiologists in developing countries. The aim of this study was to determine the clinical examination predictors to determine shoulder subluxation in patients with BPBI correlating with ultrasound confirmation. METHODS: We prospectively studied children who presented to our hospital between 2017 and 2021 diagnosed as brachial plexus birth injury. In patients developing internal rotation contracture of the shoulder, we looked for 3 standard clinical signs: reduced passive external rotation <60 degrees, deep anterior crease (DAC) and relatively short arm segment. Shoulder subluxation was defined as USG measurement of alpha angle>30 degrees and ossific nuclei of the humerus lying behind the dorsal scapular line. Sensitivity and specificity were used to assess their efficacy in clinical diagnosis of shoulder subluxation in different groups. The predicted probability of shoulder subluxation from each prediction rule was compared with actual distributions based on USG confirmation. RESULTS: Of the 58 BPBI infants who developed PER<60 degrees at the shoulder, 41 had USG confirmed shoulder subluxation. The 2 independent predictors of shoulder subluxation (PER<45 degrees and DAC) were identified in the current patient population based on data analysis. The presence of short arm segment is a very specific marker of shoulder subluxation but not sensitive. The predicted probability of shoulder subluxation from the prediction rule combining all the 3 markers were similar to the actual distributions in the current patient population. CONCLUSIONS: PER<45 degrees and presence of deep anterior crease are clinical markers indicating shoulder dislocation in patients with BPBI developing reduced external rotation at the shoulder. On the basis of the proposed clinical diagnosis algorithm, the above markers along with the selective use of USG can help in early detection and treatment of infantile shoulder dislocation.

Development and Validation of Stability-Indicating High-Performance Liquid Chromatography Method for Estimation of Lacosamide in Bulk and Its Pharmaceutical Dosage Form.

A simple, specific, accurate and stability-indicating reversed-phase high-performance liquid chromatographic method was developed for the determination of lacosamide, using C18 column and a mobile phase composed of phosphate buffer (pH 4.0):acetonitrile (40:60 v/v). The retention time of lacosamide was found to be 2.7 min. Linearity was established for lacosamide in the range of 10-50 µg/mL. The percentage recovery of lacosamide was found to be in the range of 97.37-99.20%. The drug was subjected to acid, alkali, oxidation, dry heat and photolytic degradation. The degradation studies indicated condition was well resolved from the pure drug with significant differences in their retention time values. This method can be successfully employed for quantitative analysis of lacosamide in bulk drug and formulation.

Comparison of radiation exposure associated with transradial and transfemoral access: An updated meta-analysis.

OBJECTIVES: To assess differences in radiation exposure between transradial access (TRA) and transfemoral access (TFA) for coronary procedures. BACKGROUND: TRA is associated with increased radiation exposure as compared to TFA. We compared radiation exposure between the two access sites. METHODS: Databases were searched from June 2014 to August 2021 for randomized controlled trials (RCTs) reporting coprimary outcomes of fluoroscopy time (FT) and/or dose area product (DAP) comparing TRA with TFA. Meta-regression was performed to assess the behavior of weighted mean difference (WMD) in FT from 1995 to 2021. Observational study data was used for corroborative evidence. RESULTS: Data from 8 RCTs (11,611 patients) showed the WMD of FT was 0.62 min (37 s) (95% confidence interval [CI]: [0.08-1.17], p = 0.023) in favor of TFA, WMD in DAP (9169 patients) was 1.94 Gy.cm2 (95% CI: [-2.1 to 5.9], p = 0.35) showing no significant difference. Pooled data from OBS and RCTs (83,990 patients) showed a similar trend. Studies from outside US between 1995 and 2021 showed WMD of FT between TRA and TFA of 0.88 min (52 s) (95% CI: [0.67-1.09], p = 0.005) versus 2.1 min (126 s) (95% CI: [1.38-2.8], p = 0.005) for US in favor of TFA. Meta-regression showed a declining WMD of FT between TRA and TFA from 1.6 min (96 s) in 1996 to 0.5 min (30 s) in 2020 with the lower limit of CI crossing the zero line in 2019. CONCLUSION: Radiation exposure between TRA and TFA continues to decrease overtime and is becoming clinically nonsignificant.

Preserving Radial Patency: Multiple Prior Radial Procedures and Now Large-Bore Access.

6 French percutaneous coronary intervention (PCI), has become widely adopted. We describe a case of successful 8 French transradial access (TRA) coronary intervention using state of the art hemostasis technique with preservation of radial patency after the procedure.