Immediate and Short-Term Outcome of Percutaneous Atrial Septal Defects Closure in Adult Patients.

Background Atrial septal defect secundum (ASD II) is the commonest of the congenital heart diseases in the adult population and the closure of ASD II causes a significant improvement in hemodynamics and the clinical status of the patient. However, it carries certain risks, especially the development of post-closure pulmonary edema and congestive cardiac failure, which may lead to death. Therefore, this study was designed to share our experience and to evaluate the immediate and short-term outcomes of percutaneous closure of ASD II in adult patients presenting at a tertiary care cardiac center in Karachi, Pakistan. Methodology In this study, we included 30 adult (≥ 40 years) patients who underwent percutaneous ASD II closure at the pediatric cardiology department of the National Institute of Cardiovascular Diseases (NICVD), Karachi, Pakistan, between June 1, 2017, and July 31, 2019. Data for this study were extracted from a prospectively collected departmental database. Extracted data for this study consisted of demographic profile, comorbid conditions, echocardiographic findings, cardiac catheterization data, pre and post six-month electrocardiographic findings, and New York Heart Association (NYHA) Functional Classification (FC). Results Out of 30 adult patients, 18 (60%) were female. The mean age of the patients at the time of ASD closure was 51.43 ± 7.09 years, ranging between 40 and 67 years. None of the patients had any post-intervention complications. Mean systolic pulmonary artery pressure (SPAP) on cardiac catheterization pre-implantation was 49.8 ± 16.3 mmHg range was 20-90 mmHg while SPAP immediately after device implantation was 37 ± 11.4 range 20 to 65 mmHg with p<0.001. Mean SPAP on pre-catheterization echocardiography was 58.8 ± 14.3, range 30-95 mmHg, while after six months, the mean SPAP was 34.5 ± 7.2, range 20-45 mmHg, with p<0.001 in 28 (93.3%) patients (in two patients, there was no TR). There was no mortality up till six months after the intervention. The functional class (FC) after six months of the procedure improved in most, 90% (27), of the patients. Conclusion There were no complications immediately after the procedure. After six months, post-procedure SPAP decreased to < 50 mmHg in the majority of patients (96.6%). Functional class (FC) improved in most (90%) of the adult (≥ 40 years) patients undergone percutaneous atrial septal defects closure. Therefore, percutaneous closure of ASD II is a safe and effective procedure for adult patients.

Comparison of Size of Pulmonary Artery and Its Branches on Transthoracic Echocardiography Versus Computed Tomographic Angiography in Patients with Tetralogy of Fallot.

Background Transthoracic echocardiography (TTE) plays a vital role in the assessment of the surgical management of patients with tetralogy of Fallot (TOF). Accurate assessment of the main pulmonary valve annulus, main pulmonary artery (MPA), and branch pulmonary arteries are crucial for decision-making regarding the surgical approach in the form of total correction. It is also important for performing a systemic-to-pulmonary artery shunt operation and affects the outcome. In some patients with poor echogenic windows, it is sometimes difficult to obtain accurate measurements. Cardiac computed tomographic angiography (CTA) can be a superior diagnostic modality. Therefore, the aim of this study was to evaluate the degree of agreement between TTE and CTA in assessing the main pulmonary valve annulus and the size of the MPA and its branches among patients with TOF patients. Methodology Patients above one year of age, with TOF, presented during the study period of six months - from January 1, 2019, to June 30, 2019, were included in the study. All the patients had TTE and cardiac CTA to assess the annulus and the size of the MPA and its branches (right pulmonary artery (RPA) and left pulmonary artery (LPA)). CTA measurement of all parameters was compared with TTE measurement of the same on three different views each by computing the Bland-Altman plot and Pearson correlation coefficients. Results A total of 73 TOF patients were included in this study. The correlation coefficients between CTA and TTE for the measurement of the annulus were 0.767 and 0.833 for the parasternal short-axis view and the subcostal view, respectively. The correlation coefficients between CTA and TTE for the measurement of MPA were 0.820 and 0.866 for the parasternal short-axis view and the suprasternal view, respectively. The correlation coefficients between CTA and TTE for the measurement of RPA were 0.883 and 0.897 for the parasternal short-axis view and the suprasternal view, respectively. Similarly, the correlation coefficients between CTA and TTE for the measurement of LPA were 0.848 and 0.877 for the parasternal short-axis view and the suprasternal view, respectively. Conclusion In conclusion, there is a strong correlation and agreement between cardiac CTA and TTE for the assessment of the annulus and the size of the pulmonary artery (PA) and its branches in patients with TOF.

Incidence of Aortic Regurgitation in Association with Type of Ventricular Septal Defects and its Immediate and Intermediate Outcome after Surgical Closure.

Introduction Ventricular septal defect (VSD) is one of the more common congenital heart defects, and aortic regurgitation (AR) is its major complication if it remains unrepaired. We aim to determine the AR incidence in various types of VSD, its immediate and intermediate six to 12-month post-VSD repair outcomes of AR. Methods We conducted a retrospective review of medical records of all children aged 18 years or younger who were diagnosed with single VSD at our institution from 2016 to 2018. VSD was classified according to its location and relation to the tricuspid annulus and semilunar valve. AR severity grading was done according to the American Society of Echocardiography, and vena contracta width (VC) was taken as the main parameter for severity. We defined trivial-to-mild AR as VC width less than 0.3 cm, moderate AR was 0.3-0.6 cm VC width, and severe AR was VC width of more than 0.6 cm. Immediate and intermediate outcomes of surgical closure, such as residual VSD and AR, were observed. Results One hundred ninety patients with isolated single VSD were included in the study. Of those, 114 patients had perimembranous VSD (60.0%), 64 patients had muscular VSD (33.7%), and 12 patients had supracristal VSD (6.3%). The median age of our study cohort was six months, with a male to female ratio of 1.3:1. Aortic valve prolapse (28.9%; n = 55) and AR (23.2%; n = 44) were the most common findings on echocardiographic evaluation of VSD patients. Most cases of VSD with AR had trivial-to-mild AR, (68.2%; n = 30). AR was most commonly seen in supracristal VSD (83.3%; n = 10) followed by perimembranous VSD (28.9%; n = 33). VSD closed spontaneously in 34 patients (17.9%) and 98 patients (51.6%) patients underwent surgery. Residual VSD after surgical closure was present in 57.1% (56) and 17.3% (17) of the patients immediate postoperatively and six- to 12-month postoperative follow-up, respectively. Similarly, residual AR after surgical closure of VSD was present in 32.7% (32) and 15.3% (15) of the patients immediate postoperatively and six- to 12-month postoperative follow-up, respectively. Conclusion The incidence of AR with VSD was very high in our study; AR was most commonly associated with supracristal VSD. After surgical repair, mild AR decreased with time. Early corrective surgery of VSD can prevent this complication and help improve outcomes.

The Impact of Antiepileptic Drugs on Vitamin Levels in Epileptic Patients.

BACKGROUND: The impact of antiepileptics on serum vitamin levels is controversial and uncertain. With no clear conclusions on the impact of antiepileptics on serum levels of vitamins, there is a need for further clinical studies in order to ascertain the impact of old and newer antiepileptic drugs on serum levels of vitamins in epileptic patients, thus accomplishing a suitable usage of vitamins supplementation. OBJECTIVE: The intention of the present research is to confirm the hypothesis of whether or not vitamin levels are altered with antiepileptic drugs. The study also aims to reveal which vitamin levels are particularly more altered, are vitamin levels affected by gender and the type and number of antiepileptics used. METHODS: The present research was piloted in collaboration with the Department of Neurology in Qilu Hospital of Shandong University. A total of 63 serum samples of epileptic patients receiving antiepileptics as monotherapy or polytherapy were requested for analysis of nine vitamin serum levels. Total nine vitamins (B1, B2, B6, B9, B12, A, C, D and E) in epileptic patients receiving antiepileptic drugs were analyzed. The serum results of all vitamins were compiled and evaluated with SPSS. RESULTS: It was alarmingly found that serum levels of vitamin D were particularly very low in almost all (90%) epileptic patients in this study. Notably, serum levels of vitamin C and vitamin B1 were also below reference range in 72% and 46% epileptic patients, respectively. The remaining vitamins were almost in reference range for most of the patients. In our study, mean and frequency of vitamin D, C and B1 levels do not vary too much among different gender groups. The patients receiving newer antiepileptic drugs displayed a slightly increased serum vitamin D levels in comparison to the patients receiving older antiepileptic drugs. We found low vitamin D, C and B1 serum levels in patients who were on monotherapy as in comparison with patients on polytherapy. CONCLUSION: The most significant and surprising finding of this study revealed that serum vitamin D levels in particular were very low in almost all patients and in some patients' vitamin B1 serum levels were also below the reference range. More importantly, it is first time reported here that vitamin C serum levels were also below reference range in the majority of these Chinese epileptic patients. It is recommended that all these vitamins should be regularly monitored in addition to therapeutic drug monitoring of antiepileptic drugs. Additional clinical trials are required for further evaluation. It is also recommended that epileptic patients with low serum levels of these vitamins may be prescribed vitamins supplementations with antiepileptic drugs in order to control their seizures more effectively and efficiently.

Comparison of New Liquid Chromatography-Mass Spectrometry Method and Enzyme-Multiplied Immunoassay Technique for Routine Therapeutic Drug Monitoring of Vancomycin in Chinese Patients.

BACKGROUND: Therapeutic drug monitoring of vancomycin is very valuable due to the good correlation between trough levels and clinical outcome. Therefore, it is important to accurately determine the concentration of vancomycin in patient plasma for adequate dose-adjustment. The objective of this study was to develop a new liquid chromatography-mass spectrometry (LC-MS) method for determination of vancomycin in patient plasma and compare the results with those obtained from enzyme-multiplied immunoassay technique (EMIT). METHODS: After extraction by simple protein precipitation, vancomycin and bergenin (internal standard) were separated on a C18 column (150×4.6 mm, 5 µm) at 40°C by gradient elution with 0.1% formic acid and acetonitrile as the mobile phase and measured by electrospray ionization source in positive selective ion monitoring mode. Seventy-nine plasma samples from patients with severe infection were analyzed by enzyme-multiplied immunoassay technique and LC-MS method. MedCalc 15.2 software with Bland-Altman analysis and Passing-Bablok regression analysis was used for statistical analysis. RESULTS: The weighted (1/x2) calibration curve of the validated LC-MS was linear within the concentration range of 0.25 - 40 µg/mL. The inter- and intra-day precisions (%RSD) were less than 10.0%. No significant matrix effect was observed in the relevant time ranges. Comparison of the two methods indicated that results of the LC-MS were close to that of EMIT with a correlation coefficient of 0.957. Upon Bland-Altman analysis, the bias amounted to 2.9 µg/mL (95% confidence intervals of -3.4 - 9.2 µg/mL). CONCLUSIONS: The established LC-MS method and EMIT were both suitable for routine TDM of vancomycin.

Therapeutic Drug Monitoring of Phenytoin by Simple, Rapid, Accurate, Highly Sensitive and Novel Method and Its Clinical Applications.

BACKGROUND: Phenytoin has very challenging pharmacokinetic properties. To prevent its toxicity and ensure efficacy, continuous therapeutic monitoring is required. It is hard to get a simple, accurate, rapid, easily available, economical and highly sensitive assay in one method for therapeutic monitoring of phenytoin. OBJECTIVE: The present study is directed towards establishing and validating a simpler, rapid, an accurate, highly sensitive, novel and environment friendly liquid chromatography/mass spectrometry (LC/MS) method for offering rapid and reliable TDM results of phenytoin in epileptic patients to physicians and clinicians for making immediate and rational decision. METHODS: 27 epileptics patients with uncontrolled seizures or suspected of non-compliance or toxicity of phenytoin were selected and advised for TDM of phenytoin by neurologists of Qilu Hospital Jinan, China. The LC/MS assay was used for performing of therapeutic monitoring of phenytoin. The Agilent 1100 LC/MS system was used for TDM. The mixture of Ammonium acetate 5mM: Methanol at (35: 65 v/v) was used for the composition of mobile phase. The Diamonsil C18 (150mm×4.6mm, 5µm) column was used for the extraction of analytes in plasma. The samples were prepared with one step simple protein precipitation method. The technique was validated with the guidelines of International Conference on Harmonisation (ICH). RESULTS: The calibration curve demonstrated decent linearity within (0.2-20 µg/mL) concentration range with linearity equation, y= 0.0667855 x +0.00241785 and correlation coefficient (R2) of 0.99928. The specificity, recovery, linearity, accuracy, precision and stability results were within the accepted limits. The concentration of 0.2 µg/mL was observed as lower limit of quantitation (LLOQ), which is 12.5 times lower than the currently available enzyme-multiplied immunoassay technique (EMIT) for measurement of phenytoin in epilepsy patients. CONCLUSION: A rapid, simple, economical, precise, highly sensitive and novel LC/MS assay has been established, validated and applied successfully in TDM of 27 epileptics patients. It was alarmingly found that TDM results of all these patients were out of safe range except two patients. However, it needs further evaluation. Besides TDM, the stated method can also be applied in bioequivalence, pharmacokinetics, toxicokinetics and pharmacovigilance studies.