Development of RP-HPLC Method of Tizanidine HCL with Some Validation Parameter.

This study compiles the information for the development of analytical methods for estimation of the Tizanidine HCl that will be helpful for further research work on this drug and its impurity. The present Literature survey provides information about the Analytical methods like UV,TLC,RP-HPLC,HPTLC,UHPLC and other methods have been reported for Tizanidine HCl drug individually and along with other drugs. The analysis of published data revealed that, there was only UV spectroscopic method (calibration curve metod) is reported for estimation of Tizanidine HCl fixed dose combination. Estimation of Tizanidine HCl by superlative RP-HPLC method i.e. Mobile phase- Acetonitrile: phosphate buffer (pH: 7.5) (50:50%v/v), Column C18 (250mm*4mm*5µm), Flow rate- 1.0 ml/min, Wavelength: 318 nm. Optimized HPLC condition was validated by assessing validation parameters and it meet the acceptance criteria set by ICH. It was showed method was linear and precise. The validated RP-HPLC-PDA method can be used for routine analysis of Tizanidine HCl in tablet.

Association of Atrial Fibrillation Burden and Mortality Among Patients With Cardiac Implantable Electronic Devices.

BACKGROUND: Current estimates of atrial fibrillation (AF)-associated mortality rely on claims- or clinical-derived diagnoses of AF, limit AF to a binary entity, or are confounded by comorbidities. The objective of the present study is to assess the association between device-recognized AF and mortality among patients with cardiac implantable electronic devices capable of sensitive and continuous atrial arrhythmia detection. Secondary outcomes include relative mortality among cohorts with no AF, paroxysmal AF, persistent AF, and permanent AF. METHODS: Using the deidentified Optum Clinformatics US claims database (2015 to 2020) linked to the Medtronic CareLink database, we identified individuals with a cardiac implantable electronic device who transmitted data ≥6 months after implantation. AF burden was assessed during the first 6 months after implantation (baseline period). Subsequent mortality, assessed from claims data, was compared between patients with and those without AF, with adjustment for age, geographic region, insurance type, Charlson Comorbidity Index, and implantation year. RESULTS: Of 21 391 patients (age, 72.9±10.9 years; 56.3% male) analyzed, 7798 (36.5%) had device-recognized AF. During a mean of 22.4±12.9 months (median, 20.1 [12.8-29.7] months) of follow-up, the overall incidence of mortality was 13.5%. Patients with AF had higher adjusted all-cause mortality than patients without AF (hazard ratio, 1.29 [95% CI, 1.20-1.39]; P<0.001). Among those with AF, patients with nonparoxysmal AF had the greatest risk of mortality (persistent AF versus paroxysmal AF: hazard ratio, 1.36 [95% CI, 1.18-1.58]; P<.001; permanent AF versus paroxysmal AF: hazard ratio, 1.23 [95% CI, 1.14-1.34]; P<.001). CONCLUSIONS: After adjustment for potential confounding factors, presence of AF was associated with higher mortality than no AF in our cohort of patients with cardiac implantable electronic devices. Among those with AF, nonparoxysmal AF was associated with the greatest risk of mortality.

Impact of Atrial Fibrillation Burden on Health Care Costs and Utilization.

BACKGROUND: Integrating patient-specific cardiac implantable electronic device (CIED)-detected atrial fibrillation (AF) burden with measures of health care cost and utilization allows for an accurate assessment of the AF-related impact on health care use. OBJECTIVES: The goal of this study was to assess the incremental cost of device-recognized AF vs no AF; compare relative costs of paroxysmal atrial fibrillation (pAF), persistent atrial fibrillation (PeAF), and permanent atrial fibrillation (PermAF) AF; and evaluate rates and sources of health care utilization between cohorts. METHODS: Using the de-identified Optum Clinformatics U.S. claims database (2015-2020) linked with the Medtronic CareLink database, CIED patients were identified who transmitted data ≥6 months postimplantation. Annualized per-patient costs in follow-up were analyzed from insurance claims and adjusted to 2020 U.S. dollars. Costs and rates of health care utilization were compared between patients with no AF and those with device-recognized pAF, PeAF, and PermAF. Analyses were adjusted for geographical region, insurance type, CHA2DS2-VASc score, and implantation year. RESULTS: Of 21,391 patients (mean age 72.9 ± 10.9 years; 56.3% male) analyzed, 7,798 (36.5%) had device-recognized AF. The incremental annualized increased cost in those with AF was $12,789 ± $161,749 per patient, driven by increased rates of health care encounters, adverse clinical events associated with AF, and AF-specific interventions. Among those with AF, PeAF was associated with the highest cost, driven by increased rates of inpatient and outpatient hospitalization encounters, heart failure hospitalizations, and AF-specific interventions. CONCLUSIONS: Presence of device-recognized AF was associated with increased health care cost. Among those with AF, patients with PeAF had the highest health care costs. Mechanisms for cost differentials include both disease-specific consequences and physician-directed interventions.

The value of ultrasound enhancing agents in the echocardiographic acquisition of pulmonary artery systolic pressure: An invasive to non-invasive correlation study.

PURPOSE: Right heart catheterization (RHC) is the gold standard for the assessment of pulmonary artery systolic pressures (PASP). Despite high utilization of echocardiography for the non-invasive assessment of PASP, the data comparing real-time non-invasive echocardiographic PASP with invasive PASP is limited. Furthermore, evidence regarding the utility and diagnostic accuracy of ultrasound enhancing agents (UEA) for non-invasive PASP assessment is lacking. To evaluate the accuracy of non-invasive PASP assessment with real-time invasive measures and the incremental benefit of UEA in this setting. METHODS: This was a prospective cohort study of 90 patients, undergoing clinically indicated RHC for hemodynamic assessment. All patients underwent a limited echocardiogram during RHC. Tricuspid regurgitant velocity (TRV) was measured on unenhanced echo, in the setting of centrally administrated agitated saline, then as either centrally administered or peripherally administered UEA. RESULTS: Of the 90 patients enrolled in our study, 41% had pulmonary hypertension. The overall mean PASP measured by RHC was 32.8 mmHg (+/- 11.3 mmHg). Unenhanced echocardiograms had a moderate correlation with invasive PASP (r = 0.57; p = < 0.001) which improved to a strong correlation with administration of agitated saline (r = 0.75; p = < 0.001) or centrally administered UEA (r = 0.77; p = < 0.001), with the best correlation noted with peripherally administered UEA (r = 0.83; p = < 0.001). Against invasive PASP, agitated saline enhanced PASP had the lowest bias (0.12mmHg; -15.6 to 15.8mmHg) when compared with all other non-invasive measures of PASP. CONCLUSIONS: Unenhanced echocardiographic estimation of TRV was found to have a poorer correlation with invasively measured PASP when compared to agitated saline and centrally administered UEA. Agitated saline enhanced PASP demonstrated the lowest bias with invasive PASP when compared to other non-invasive measures of PASP.

Heart Rate Variability in Psychiatric Disorders: A Systematic Review.

Introduction: Heart rate variability (HRV) is a measure of the fluctuation in time interval between consecutive heart beats. Decreased heart rate variability has been shown to have associations with autonomic dysfunction in psychiatric conditions such as depression, substance abuse, anxiety, and schizophrenia, although its use as a prognostic tool remains highly debated. This study aims to review the current literature on heart rate variability as a diagnostic and prognostic tool in psychiatric populations. Methods: A literature search was conducted using the MEDLINE, EMBASE, Cochrane, and PsycINFO libraries to identify full-text studies involving adult psychiatric populations that reported HRV measurements. From 1647 originally identified, 31 studies were narrowed down through an abstract and full-text screen. Studies were excluded if they enrolled adolescents or children, used animal models, enrolled patients with another primary diagnosis other than psychiatric as outlined by the diagnostic and statistical manual of mental disorders (DSM) V, or if they assessed HRV in the context of treatment rather than diagnosis. Study quality assessment was conducted using a modified Downs and Blacks quality assessment tool for observational rather than interventional studies. Data were reported in four tables: 1) summarizing study characteristics, 2) methods of HRV detection, 3) key findings and statistics, and 4) quality assessment. Results: There is significant variability between studies in their methodology of recording as well as reporting HRV, which makes it difficult to meaningfully interpret data that is clinically applicable due to the presence of significant bias in existing studies. The presence of an association between HRV and the severity of various psychiatric disorders, however, remains promising. Conclusion: Future studies should be done to further explore how HRV parameters may be used to enhance the diagnosis and prognosis of several psychiatric disorders.

Validation of the SCALE-CryoAF risk model to predict very late return of atrial fibrillation after cryoballoon ablation.

BACKGROUND: To date, few risk models have been validated to predict recurrent atrial fibrillation (AF) >1 year after ablation. The SCALE-CryoAF score was previously derived to predict very late return of AF (VLRAF) >1 year following cryoballoon ablation (CBA), with strong predictive ability. In this study, we aim to validate the SCALE-CryoAF score for VLRAF after CBA in a novel patient cohort. METHODS: Retrospective analysis of a prospectively maintained single-center database was performed. Inclusion criteria were pulmonary vein isolation using CBA 2017-2020. Exclusion criteria included prior ablation, <1-year follow-up, lack of pre-CBA echocardiogram, additional ablation lesion sets, and documented AF recurrence 90-365 days post-CBA. The area under the curve (AUC) of SCALE-CryoAF was compared to the derivation value and other established risk models. RESULTS: Among 469 CBA performed, 241 (61% male, 62.8 ±11.7 years old) cases were included in analysis. There were 37 (15.4%) patients who developed VLRAF. Patients with VLRAF had a higher SCALE-CryoAF score (VLRAF 5.4 ± 2.7; no VLRAF 3.1 ± 2.9; p<0.001). SCALE-CryoAF was linearly associated with VLRAF (y=14.35x-11.72, R2=0.99), and a score > 5 had a 32.7% risk of VLRAF. The SCALE-CryoAF risk model predicted VLRAF with an AUC of 0.74, which was similar to the derivation value (AUCderivation: 0.73) and statistically superior to MB-LATER, CHA2DS2-VASc, and CHADS2 scores. CONCLUSIONS: The current analysis validates the ability of SCALE-CryoAF to predict VLRAF after CBA in a novel patient cohort. Patients with a high SCALE-CryoAF score should be monitored closely for recurrent AF >1 year following CBA.

Comparison of data quality and monitoring completion rates between clinic and self-applied ECG patches.

BACKGROUND: Since the onset of the coronavirus disease 2019 (COVID-19) pandemic, direct-to-patient, self-applied ECG patch use has substantially increased. There are limited data comparing clinic with self-applied electrocardiogram (ECG) patches. OBJECTIVE: The purpose of this study was to compare rates of ECG patch return, percentages of time patches yielded analyzable data (analyzable time), and percentages of prescribed time ECG patches were worn between clinic and self-applied ECG patches before and during COVID-19. METHODS: A retrospective analysis of patients prescribed an ECG patch during "pre-COVID" (March 1, 2019, through March 1, 2020) and "COVID" (April 4, 2020, through April 1, 2021) years was performed. ECG patch return rates, mean percentages of analyzable time, and mean percentages of prescribed wear time were compared between clinic and self-applied groups. RESULTS: Among the 29,093 ECG patch prescriptions (19% COVID self-applied), the COVID self-applied group had a lower return rate (90.8%) than did both clinic-applied groups (COVID: 97.1%; pre-COVID: 98.1%; P < .001). Among the 28,048 ECG patches (17.5% self-applied) returned for analysis, the COVID self-applied group demonstrated a lower mean percentage of analyzable time (95.9% ± 8.2%) than did both clinic-applied groups (COVID: 96.6% ± 6.6%; pre-COVID 96.6% ± 7.4%; P < .001). There were no differences in the mean percentage of prescribed wear time between groups (pre-COVID clinic-applied: 96.7% ± 34.3%; COVID clinic-applied: 97.4% ± 39.8%; COVID self-applied: 98.1% ± 52.1%; P = .09). CONCLUSION: Self-applied ECG patches were returned at a lower rate and had a statistically lower percentage of analyzable time than clinic-applied patches. However, there were no differences between groups in mean percentages of prescribed wear time, and mean percentages of analyzable time were >95% in all groups.