Prospective Observational Study Research Articles

Accuracy of orthodontic movements with 3D printed aligners: A prospective observational pilot study.

Owing to the availability of 3D software, scanners, and printers, clinicians are encouraged to produce in-office aligners. Recently, a new directprinting resin (Tera Harz TC-85DAC) has been introduced. Studies on its mechanical characteristics and biological effects have been published; however, evidence on its efficacy in orthodontic treatment remains scarce. This pilot study aimed to investigate the accuracy of teeth movement achieved with directprinted aligners. Seventeen patients (eight males and nine females) with a mean age of 27.67 ± 8.95 years, presenting with dental rotations < 30° and spaces/crowding < 5 mm, were recruited for this study. The teeth movement was planned starting from a T0 digital dental cast. The 3D direct-printed aligners were produced using Tera Harz TC-85DAC resin. Once the orthodontic treatment was completed, a final digital cast was obtained (T1). The planned teeth positions were then superimposed onto the T0 and T1 digital models. The differences between the programmed movements and the achieved overall torque, tip, rotation, and transverse dimensions were assessed using the paired t test or Wilcoxon's signed rank test. The overall accuracies for torque, tip, and rotation were 67.6%, 64.2%, and 72.0%, respectively. The accuracy of the change in transverse diameter was 99.6%. Within the limits of the present pilot study (difficulties with abnormally shaped teeth and use of attachments), it can be concluded that 3D printed aligners can be successfully printed in-house and utilized for mildly crowded cases, with a comparable accuracy of tooth movement to that of other aligners.

Assessment of disease pattern and drug utilization among neurology intensive care unit patients in a developing country: an observational analysis

ABSTRACT Objective This study aimed to assess the disease pattern and drug utilization among admitted patients in a tertiary-care hospital’s neuro ICU. Methods A prospective observational cohort study was conducted between August 2022 and January 2023. Patients of any age and gender admitted to the neuro ICU were included, but those who declined to participate were excluded. Demographics, clinical, and medication details were consistently gathered and maintained until discharge. The World Health Organisation (WHO)/International Network of Rational Use of Drugs (INRUD) prescribing indicators and the Anatomical Therapeutic Chemical (ATC) classification/Defined Daily Dose (DDD) system were used to evaluate drug use. Results A total of 516 patients were included, predominantly male (65.1%), with an average age of 54.6 ± 15.07 years. The most common diagnosis was stroke (72.3%), followed by seizure disorders (6.6%), and central nervous system infections (5.4%). Patients received an average of 7.8 medications, 32.3% prescribed by generic name, 16.0% antibiotics, 74.1% injection, and 100% essential drugs. A (28.5%), C (19.2%), N (17.3%), J (19.2%), B (13.5%), and R (2.3%) were commonly prescribed ATC classes of medications. Number of DDDs was maximum for pantoprazole, and furosemide. Based on discharged status, 41.0% were discharged on request, 24.8% against medical advice, 23.8% routine, and 10.2% mortality during hospitalization. Conclusion Our study reveals a high prevalence of hemorrhagic stroke, especially among men, diverging from global ischemic stroke trends. Irregular hypertension treatment is the primary cause, exacerbated by low healthcare knowledge in rural areas, where patients often discharge themselves due to socioeconomic reasons. Urgent public awareness campaigns and further research are needed to address this elevated hemorrhagic stroke incidence.

A comparison of two weaning strategies for non-invasive ventilation in chronic obstructive pulmonary disease patients with acute respiratory failure.

Non-Invasive Ventilation (NIV) is a crucial therapy for managing acute exacerbations of Chronic Obstructive Pulmonary Disease (COPD) with hypercapnic respiratory failure. Research has shown that NIV can decrease the rate of endotracheal intubation, length of hospital and Intensive Care Unit stays, and mortality. There are three main strategies for weaning patients off NIV: gradual reduction of NIV duration, gradual reduction of NIV pressure support, and immediate cessation of NIV. To compare the rate of successful withdrawal of COPD patients with acute hypercapnic respiratory failure, one group will use a stepwise reduction of duration of NIV, while the other group will use a stepwise reduction of pressure support. This study was a prospective observational study conducted at the Department of Pulmonary Medicine, Institute of Chest Diseases, Government Medical College, Kozhikode, over a period of 15months. The study population consisted of all COPD patients admitted to the Pulmonary Medicine ward or ICU with acute hypercapnic respiratory failure who were managed with non-invasive ventilation (NIV) without the need for invasive mechanical ventilation. Exclusions included patients requiring NIV for respiratory diseases other than COPD, those with significant comorbiditieslike acute left ventricular failure or fluid overload states as in chronic kidney disease, COVID-19 positive patients, patients on home NIV, patients who needed intubation early in treatment, and patients unwilling to participate in the study. The sample size was 140. Initial NIV settings and other management decisions prior to enrolment in the study were made by the treating physician according to standard protocols. Once weaning criteria were met (i.e., arterial pH > 7.35, SpO2 ≥ 90% at an FiO2 ≤ 50%, respiratory rate ≤ 25 breaths per minute, heart rate ≤ 120 beats per minute, systolic BP > 90mm Hg, and no signs of respiratory distress), patients were assigned to either group 1 or group 2 by purposive sampling. Group 1: stepwise reduction of duration of NIV use, with a reduction to 16h per day on day 1 of enrolment, 12h on day 2 (including 6-8h of nocturnal NIV), 6-8h on day 3, and NIV withdrawal on day 4. Group 2: stepwise reduction of pressure support, with pressure support reduced by 2-4cm every 4-6h until Inspiratory Positive Airway Pressure is < 8cm H2O and Expiratory Positive Airway Pressure is < 4cm H2O, followed by NIV withdrawal. The clinical outcome was classified as either improved or weaning failure. Improved was defined as an objective or subjective sense of improvement. Weaning failure was defined as the presence of any of the following: respiratory rate ≥ 25/minute or increase of ≥ 50% from baseline, heart rate ≥ 140/minute or increase of ≥ 20% from baseline, SpO2 ≤ 90% on FiO2 ≥ 50%, arterial pH ≤ 7.35, or respiratory distress. Data was collected using a pro forma that included demographic details, smoking status, GOLD COPD category, comorbidities, and vital signs. ABG parameters, NIV settings at the time of hospital admission, at the time of study enrolment, and 48h after weaning were also recorded. Independent sample t-test was used to test the statistical significance of the difference between means of variables between the two groups. Pearson Chi square test and Fisher's exact test were used to compare categorical variables between the groups. A p-value of < 0.05 was considered statistically significant. NIV was successfully withdrawn in 56/70 (80%) and 50/70 (71.4%) patients in Groups 1 and 2, respectively. This difference was not statistically significant. The length of hospital stay was longer in the stepwise reduction of duration group (Group 1), but this was not statistically significant. On comparison of two methods of NIV withdrawal, it was found that neither method is superior to the other in terms of weaning failure, intubation rates, and average length of hospital stay.

Blood pressure monitoring in elderly migraineurs starting an anti-CGRP monoclonal antibody: a real-world prospective study.

While monoclonal antibodies (mAbs) targeting the CGRP pathway have revolutionized migraine management due to their improved tolerance and adherence, concerns remain about their potential impact on blood pressure (BP), especially in older patients, due to CGRP-mediated vasodilation blockade. Given the growing use of these therapies in older populations, assessing their cardiovascular (CV) safety is of paramount importance. This multicentric observational prospective study focused on migraine sufferers aged ≥ 60 who began erenumab, galcanezumab, or fremanezumab for prevention. Baseline, three-month, and twelve-month BP measurements were collected. Changes in antihypertensive medication and "Newly or Worsened Hypertensive" patients (NWHP) were assessed. Among 155 patients receiving anti-CGRP mAbs (40 Erenumab, 47 Galcanezumab, 68 Fremanezumab), 42.5% had hypertension history and 39% were on antihypertensive treatment. No significant systolic or diastolic BP changes occurred at any time point compared to baseline (all p > 0.05), with no differences between the three groups. After one year, 20/155 (12.9%) patients were considered NWHP; 11/20 had prior hypertension, and 5/11 adjusted antihypertensive therapy. Among 9/20 newly hypertensive patients, 5/9 had a single measurement above the normal threshold with no requirement for new pharmacological therapy. A higher baseline BP value was associated with increased BP (p = 0.002). The study concludes that treatment with anti-CGRP mAbs over one year does not significantly affect BP in patients aged ≥ 60, nor does it increase the incidence of hypertension compared to general population trends. Nonetheless, continuous monitoring and further long-term studies are necessary to fullya scertain the cardiovascular safety of these medications in the elderly.

Magnitude and associated factors of intra operative hypothermia among pediatric patients undergoing elective surgery atXX Comprehensive Specialized Hospital 2023: prospective observational cross sectional study Tigray, Ethiopia

Background: Hypothermia is characterized by a drop in core body temperature of less than 36 °C. It occurs frequently throughout the operating period and affects surgical patient outcomes differently in terms of morbidity and mortality. Because of coagulopathy, metabolic acidosis, multiple organ failure, hemodynamic instability, and infections, a core temperature below 34 °C is strongly associated with mortality. Objective: This study aimed to assess the magnitude and associated factors of intra-operative hypothermia in pediatric patients undergoing elective surgery at the Ayder Comprehensive Specialized Hospital. Method: A prospective observational cross-sectional study was conducted on 399 pediatric patients undergoing elective surgery at Ayder Comprehensive Specialized Hospital in Tigray, Ethiopia, from May 1, 2023, to July 30, 2023. Participants in the study were selected by a systematic random sampling technique. The data collection procedure was chart review and intra-operative temperature measurement, and the collected data were analyzed by SPSS version 23. The independent variables were analyzed using binary and multi-logistic regression. The odds ratio, 95% confidence interval, and p-value of &lt;0.05 were considered statistical significance. Result: The magnitude of intra-operative hypothermia was 52.9%. Neonate and infant [AOR: 6, 95% CI: 3.7, 9.8], (AOR=4.5, 95% CI: 2.9, 7) respectively, volume of fluid administered greater than half liter [AOR: 4.37, (95% CI, 3, 6.4)], patients who underwent surgery during the morning [AOR: 5.3, (95% CI: 3.8, 7.4)], and duration of surgery and anesthesia greater than 120 minutes [AOR: 2.7, (95% CI, 1.8, 4)] and (AOR=3.4, 95% CI, 2.4, 4.9], respectively, were factors significantly associated with intra-operative hypothermia. Conclusion and Recommendation: This study revealed a high magnitude of intraoperative hypothermia among pediatric patients. Being neonates and infants, having a cold volume of IV fluid administered greater than half a liter, entering surgery during the morning, the duration of surgery, and the anesthesia time were significantly associated with intra-operative hypothermia. We would like to advise anesthetists to use warm intravenous fluids, calculate IV fluids, and maintain room temperature.

Long-term outcomes associated with subcutaneous implantable cardioverter-defibrillators in patients with hypertrophic cardiomyopathy

Abstract Background In patients with Hypertrophic Cardiomyopathy (HCM) S-ICD is usually the preferred option as pacing is generally not indicated. However, limited data are available on its current practice adoption and long term follow-up. Purpose The present study was designed to examine in a multicenter, open-label, long-term study, the patient’s selection process for S-ICD implantation, the short and long term complications, the appropriate shock (AS) rates, shock efficacy and outcome. Methods Consecutive HCM patients with an S-ICD implanted between 2013 and 2021 in 3 international centers were enrolled in this prospective observational study. Baseline, procedural and follow-up data together with clinical evaluation, ECG, echocardiography, and telemetry checks of the S-ICD were regularly collected. Results Seventy patients (64% males) were enrolled, implanted at 41±15 years, 62 (89%) in primary prevention with a mean ESC SCD risk score of 4,5±1.9%: 25 (40%) at low risk, 17 (27%) at intermediate and 20 (33%) at high risk. Patients were followed-up for 5.1±2.3 years (327 person-years). Notably, 25 (36%) were followed for more than 6 years up to 10 years. Two patients (3%) received an appropriate shock on ventricular fibrillation and 17 (24%) were diagnosed with a de-novo atrial fibrillation, sub-clinical in 6 (9%). One TIA and 2 strokes were reported. Inappropriate shocks occurred in 4 patients (6%), all before Smart-Pass algorithm implementation. Eight patients experienced device related adverse events (11%). Conclusions S-ICDs in HCM patients followed for over 5 years showed to be effective in the conversion of VF in 2 ESC SCD high risk patients (3%) and useful in the detection of sub-clinical AF in 6 (9%). S-ICDs are implanted in patients with an overall low-intermediate ESC SCD risk, probably reflecting both the inclusion of additional risk markers (i.e extensive LGE, reduced EF and apical aneurism) and the physician perception of low device-related complications S-ICD is generally safe, but greater scrutiny may be required to avoid overtreatment in HCM patients with milder risk profiles.Real world use and candidacy of S-ICDAppropriate and inappropriate shocks

Safety and feasibility of zero-fluoroscopy technique in ablation-index guided pulmonary vein isolation: a prospective, single center trial

Abstract Introduction Pulmonary vein isolation (PVI) represents the cornerstone of catheter ablation procedures in patients with symptomatic paroxysmal/persistent atrial fibrillation (AF). Conventionally, PVI is performed using fluoroscopy, but it can also be performed using the zero-fluoroscopy (ZF) technique with the assistance of electroanatomical mapping systems and intracardiac ultrasound, achieving fluoroscopy-free procedures. Purpose Our study aimed to compare procedural data of ablation-index guided point-by-point radiofrequency (RF) PVI performed with non-zero-fluoroscopy (NZF) vs. ZF approaches. Methods We enrolled 100 consecutive patients undergoing PVI for antiarrhythmic drug- refractory AF in our prospective observational study. In the first 50 cases, PVI was performed using the NZF technique, and in the other 50 cases, the ZF technique was applied. Procedural time, fluoroscopy exposure, ablation parameters, and the occurrence of complications were compared between the two groups. Results Compared to the NZF group, procedural time (59.6±10.7 min vs. 74.6±13.2 min, p&amp;lt;0.0001) was significantly shorter in the ZF group. This difference was mainly driven by the time from puncture to the beginning of left atrial mapping, which was significantly longer in the NZF group (17 [16; 20] min vs. 31 [23; 34.5] min, p&amp;lt;0.001). No differences were found between the two approaches in the number of RF applications (81 [73; 103] vs. 83 [71; 91], p=0.67), total ablation energy (54986 ± 13093 Ws vs. 55500 ± 11907 Ws, p=0.48), and the left atrial dwelling time (41.5 [36; 52.5] min vs. 40.5 [35; 46], p=0.14). No complications occurred in either group. In the ZF group, complete elimination of fluoroscopy was achieved in all cases, resulting in significant differences in fluoroscopy time (0 [0; 0] sec vs. 132 [100; 160] sec, p&amp;lt;0.0001] and dose (0 [0; 0] mGy vs. 4.8 [4.1; 8.2] mGy, p&amp;lt;0.0001) compared to the NZF technique. The acute success rate was 100% in the study population, and no complications occurred during the study period. Conclusion Ablation-index guided ZF PVI is feasible and safe. Using this technique, the procedure time can be shortened besides achieving a similar acute success rate without increasing complications.

Dynamic change, not tonic activation, of the heart rate variability predicts onset of postoperative atrial fibrillation

Abstract Background and Aims Post-operative autonomic disturbances contribute to susceptibility to post-operative atrial fibrillation (POAF) but the nature of the autonomic disturbances and whether they precede POAF and can signal POAF onset is unclear. Methods In this prospective observational study, patients undergoing cardiac surgery were consecutively enrolled. Holter monitoring was undertaken 7 days before and after surgery with continuous heart rate variability (HRV) measurement. Cox regression was used to evaluate autonomic changes, and analyzed by restricted cubic spline (RCS) to explore individual risk levels. For the first episode of POAF, HRV indexes captured an hour before the onset of POAF were divided into six 10-minute epochs and analyzed by Friedman's Two-Way Analysis of Variance by Ranks. Results A total of 2306 patients known to have been without prior AF were enrolled and completed the study; POAF occurred in 718 (31.14%) patients. Based on univariate and multivariate analysis preoperative, tonic activation and perioperative HRV change were not significantly related to new POAF. However, in the postoperative phase, a marked increase or decrease of Δ Lg (LF/HF), Δ Lg (HF) and Δ Lg (LF) were associated with increased POAF risk. Further, examination of 10-minute epochs in the 30 minutes before the onset of POAF, revealed that progressive increase of HRV indexes. Conclusions POAF susceptibility is associated with postoperative dynamic HRV changes but not tonic autonomic state. Potentially the observation that POAF was preceded by progressive rise of HRV indexes may offer a promising signal for early warning of POAF, and permit preventive intervention.

Reliability of a Smartphone App to Objectively Monitor Performance Outcomes in Degenerative Cervical Myelopathy: Observational Study.

Developing new clinical measures for degenerative cervical myelopathy (DCM) is an AO Spine RECODE-DCM Research, an international and multi-stakeholder partnership, priority. Difficulties in detecting DCM and its changes cause diagnostic and treatment delays in clinical settings and heightened costs in clinical trials due to elevated recruitment targets. Digital outcome measures can tackle these challenges due to their ability to measure disease remotely, repeatedly, and more economically. The aim of this study is to assess the reliability of the MoveMed battery of performance outcome measures. A prospective observational study in decentralized secondary care was performed in England, United Kingdom. The primary outcome was to determine the test-retest reliability of the MoveMed performance outcomes using the intraclass correlation (ICC) of agreement . The secondary outcome was to determine the measurement error of the MoveMed performance outcomes using both the SE of the mean (SEM) of agreement and the smallest detectable change (SDC) of agreement . Criteria from the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) manual were used to determine adequate reliability (ie, ICC of agreement ≥0.7) and risk of bias. Disease stability was controlled using 2 minimum clinically important difference (MCID) thresholds obtained from the literature on the patient-derived modified Japanese Orthopaedic Association (p-mJOA) score, namely, MCID ≤1 point and MCID ≤2 points. In total, 7 adults aged 59.5 (SD 12.4) years who live with DCM and possess an approved smartphone participated in the study. All tests demonstrated moderate to excellent test-retest coefficients and low measurement errors. In the MCID ≤1 group, ICC of agreement values were 0.84-0.94 in the fast tap test, 0.89-0.95 in the hold test, 0.95 in the typing test, and 0.98 in the stand and walk test. SEM of agreement values were ±1 tap, ±1%-3% stability score points, ±0.06 keys per second, and ±10 steps per minute, respectively. SDC of agreement values were ±3 taps, ±4%-7% stability score points, ±0.2 keys per second, and ±27 steps per minute, respectively. In the MCID ≤2 group, ICC of agreement values were 0.61-0.91, 0.75-0.77, 0.98, and 0.62, respectively; SEM of agreement values were ±1 tap, ±2%-4% stability score points, ±0.06 keys per second, and ±10 steps per minute, respectively; and SDC of agreement values were ±3-7 taps, ±7%-10% stability score points, ±0.2 keys per second, and ±27 steps per minute, respectively. Furthermore, the fast tap, hold, and typing tests obtained sufficient ratings (ICC of agreement ≥0.7) in both MCID ≤1 and MCID ≤2 groups. No risk of bias factors from the COSMIN Risk of Bias checklist were recorded. The criteria from COSMIN provide "very good" quality evidence of the reliability of the MoveMed tests in an adult population living with DCM.

Radiofrequency lesion in atrial wall: how variable is it? 9 Tesla MRI analysis of RF lesion volume in a swine model

Abstract Background Little is known about radiofrequency (RF) lesion volume (rLV). Most of animal or ex-vivo studies quantify the size of RF lesions size using width and/or depth, while electrophysiologists use manufacturers’ indirect indices (such as Ablation Index or Lesion Size Index). Purpose We aimed to evaluate rLV by high resolution 9-Tesla magnetic resonance imaging (MRI), in ex-vivo swine model. We studied the variability of rLV and extra-cardiac effects in two groups of swine, one treated with low energy (LE)-long application RF (20W-50 sec) and another treated with high energy (HE)-short application RF (50 W-20 sec). Methods This was a prospective observational study on 18 piglets, that were anesthetized, mechanically ventilated, and divided into LE (n = 9) and HE (n = 9) groups (Figure 1). An irrigated contact force catheter was used to perform RF applications in 4 largely separated spots: 2 on right atrium and 2 on left atrium wall. RF parameters were monitored during RF. Each animal was sacrificed after 5-7 days, and RF lesion samples were excised and acquired by 9 MRI. Results 70 RF applications were performed (36 in LE group and 34 in HE group). MRI was performed on 26 samples of LE group and 28 of HE group (Figure 2). The median RF lesion volume was 89.3 mm3 (IQR 47.9-175.9). Regarding lesion volume, the HE groups showed 35% higher volume than LE group (mean lesion volume 86.2 mm3 vs 116.3 mm3, p = 0.119). HE group also showed more complications (0 vs 7, p=0.02) and more extracardiac lesion (14 vs 18, p=0.613). Conclusions There was a wide and unpredictable variability of RF lesion on atrial wall, even under controlled experimental conditions, which could explain arrhythmias recurrences. The variability seems greatest, although not statistically significant, during HE applications. The dose/effect relationship needs to be carefully studied for treatments of cardiac arrhythmias for both RF and other forms of energy available today.Study flow-chartComparison between groups

Management and Outcomes of Pulmonary Artery Hypertension and Eisenmenger Syndrome During Pregnancy: A Prospective Observational Cohort Study

(BJOG. 2023;130(10):1258–1268) Pregnancies complicated by pulmonary arterial hypertension (PAH) and Eisenmenger syndrome often result in severe maternal and fetal morbidity and mortality. Clinicians often counsel women with these conditions to avoid pregnancy or terminate a pregnancy. Multidisciplinary specialty centers, however, have seen good outcomes in these high-risk women and their babies.

Docetaxel, Oxaliplatin with Capecitabine (TEX Regimen) in Metastatic Gastric and Gastroesophageal Adenocarcinoma: A Prospective Single-Arm Observational Study from a Tertiary Cancer Center in Kashmir

Abstract Background Metastatic gastric and gastroesophageal adenocarcinoma (MGGEAC) is a challenging disease with limited treatment options. The Taxotere, Eloxatin, and Xeloda (TEX) regimen has shown promising results in several clinical trials. There exists a dearth of data pertaining to the efficacy and tolerance of the treatment approach in the populace of Kashmir. Methods This study was performed at the Department of Medical Oncology, Sher-I-Kashmir Institute of Medical Sciences, Srinagar, Jammu and Kashmir. Patients with MGGEAC received treatment with biweekly TEX regimen that included docetaxel 50 mg/m2-D1, oxaliplatin 85 mg/m2-D1, and capecitabine 1250 mg/m2/day, twice daily orally, for 14 days. The effectiveness of the regimen was assessed based on the overall response rate (ORR), progression-free survival (PFS), and overall survival (OS), along with the prognostic factors, safety, and tolerability of the regimen. Results The ORR was 63.5% after four cycles. The median PFS and OS were 9.1 and 13 months, respectively. Univariate and multivariate analysis showed that a higher number of sites of metastases is associated with poor PFS. The TEX regimen was well tolerated. The most observed grade 3 to 4 toxicities were neutropenia (36.7%), anemia (20%), fatigue (20%), and febrile neutropenia (16.7%). Conclusion Using the TEX regimen in MGGEAC showed better response rates and a slightly longer PFS. A higher number of sites of metastases is a poor prognostic factor in MGGEAC, as seen in our study. The toxicity profile shows that the regimen is tolerable. We recommend a randomized controlled study comparing CapeOx with TEX to test this regimen further.

Efficacy and Safety of Surgical Peripheral Iridectomy, Goniosynechialysis, and Goniotomy for Advanced Primary Angle-closure Glaucoma without Cataract: One-year Results of a Multicenter Study.

The combination of surgical peripheral iridectomy, goniosynechialysis, and goniotomy is a safe and effective surgical approach for advanced primary angle-closure glaucoma without cataract. To evaluate the efficacy and safety of surgical peripheral iridectomy (SPI), goniosynechialysis (GSL), and goniotomy (GT) in advanced primary angle-closure glaucoma (PACG) eyes without cataract. A prospective multicenter observational study was performed for patients who underwent combined SPI, GSL, and GT for advanced PACG without cataract. Patients were assessed before and after the operation. Complete success was defined as achieving intraocular pressure (IOP) between 6-18mm Hg with at least a 20% reduction compared to baseline, without the use of ocular hypotensive medications or reoperation. Qualified success adopted the same criteria but allowed medication use. Factors associated with surgical success were analyzed using logistic regression. A total of 61 eyes of 50 advanced PACG were included. All participants completed 12 months of follow-up. Thirty-six eyes (59.0%) achieved complete success, and 56 eyes (91.8%) achieved qualified success. Preoperative and postsurgical at 12 months mean IOPs were 29.7±7.7 and 16.1±4.8mm Hg, respectively. The average number of ocular hypotensive medications decreased from 1.9 to 0.9 over 12 months. The primary complications included IOP spike (n=9), hyphema (n=7), and shallow anterior chamber (n=3). Regression analysis indicated that older age (odds ratio [OR]=1.09; P=0.043) was positively associated with complete success, while a mixed angle closure mechanism (OR=0.17; P=0.036) reduced success rate. The combination of SPI, GSL, and GT is a safe and effective surgical approach for advanced PACG without cataract. It has great potential as a first-line treatment option for these patients.

Immunogenicity of a bivalent BA.1 COVID-19 booster vaccine in people with HIV in the Netherlands.

We evaluated the immunogenicity of a bivalent BA.1 COVID-19 booster vaccine in people with HIV (PWH). Prospective observational cohort study. PWH aged ≥45 years received Wuhan-BA.1 mRNA-1273.214 and those < 45 years Wuhan-BA.1 BNT162b2. Participants were propensity score-matched 1:2 to people without HIV (non-PWH) by age, primary vaccine platform (mRNA-based or vector-based), number of prior COVID-19 boosters and SARS-CoV-2 infections, and spike (S1)-specific antibodies on the day of booster administration. The primary endpoint was the geometric mean ratio (GMR) of ancestral S1-specific antibodies from day 0 to 28 in PWH compared to non-PWH. Secondary endpoints included humoral responses, T-cell responses, and cytokine responses up to 180 days post-vaccination. Forty PWH received mRNA-1273.214 (N = 35) or BNT162b2 (N = 5) following mRNA-based (N = 29) or vector-based (N = 11) primary vaccination. PWH were predominantly male (87% vs 26% of non-PWH) and median 57 years (interquartile range [IQR] 53-59). Their median CD4+ T-cell count was 775 (IQR 511-965) and the plasma HIV-RNA load was < 50 copies/mL in 39/40. The GMR of S1-specific antibodies by 28 days post-vaccination was comparable between PWH (4.48, 95% confidence interval [CI] 3.24-6.19) and non-PWH (4.07, 95% CI 3.42-4.83). S1-specific antibody responses were comparable between PWH and non-PWH up to 180 days, and T-cell responses up to 90 days post-vaccination. IFN-γ, IL-2, and IL-4 cytokine concentrations increased 28 days post-vaccination in PWH. A bivalent BA.1 booster vaccine was immunogenic in well-treated PWH, eliciting comparable humoral responses to non-PWH. However, T-cell responses waned faster after 90 days in PWH compared to non-PWH.

Impact of hyponatremia in patients hospitalized in Internal Medicine units: Hyponatremia in Internal Medicine units.

The aim of this study was to analyze the impact and the clinical and evolutionary characteristics of hypotonic hyponatremia in patients hospitalized in Internal Medicine units. Prospective multicenter observational study of patients with hypotonic hyponatremia (<135 mmol/L) in 5 hospitals in southern Spain. Patients were included according to point prevalence studies carried out every 2 weeks between March 2015 and October 2017, by assessing demographic, clinical, analytical, and management data; each patient was subsequently followed up for 12 months, during which time mortality and readmissions were assessed. A total of 501 patients were included (51.9% women, mean age = 71.3 ± 14.24 years), resulting in an overall prevalence of hyponatremia of 8.3%. The mean comorbidities rate was 4.50 ± 2.41, the most frequent diagnoses being heart failure (115) (23%), respiratory infections (65) (13%), and oncological pathologies (42) (6.4%). Of the total number of hyponatremia cases, 180 (35.9%) were hypervolemic, 164 (32.7%) hypovolemic, and 157 (31.3%) were euvolemic. A total of 87.4% did not receive additional diagnostic tests to establish the origin of the condition and 30% did not receive any treatment. Hospital mortality was 15.6% and the mean length of stay was 14.7 days. Euvolemic and admission hyponatremia versus hyponatremia developed during admission were significantly associated with lower mortality rates (P = .037). Mortality at 1 year and readmissions were high (31% and 53% of patients, respectively). Hyponatremia was common in Internal Medicine areas, with hypervolemic hyponatremia being the most frequent type. The mortality rate was high during admission and at follow-up; yet there is a margin for improvement in the clinical management of this condition.

Abnormal vascular thickness and stiffness in young adults with type 1 diabetes: new insights from cutting-edge ultrasound modalities

BackgroundCardiovascular disease (CVD) remains the leading cause of morbidity and mortality in patients with Type 1 Diabetes (T1D). Early markers of CVD include increased carotid intima-media thickness (CIMT) and pulse wave velocity (PWV), but these existing ultrasound technologies show limited spatial and temporal resolution in young adults. The purpose of this study is to evaluate the utility of high-resolution ultrasound modalities, including high frequency ultrasound CIMT (hfCIMT) and ultrafast ultrasound PWV (ufPWV), in young adults with Type 1 Diabetes.MethodsThis is a prospective single-center observational cohort study including 39 participants with T1D and 25 age and sex matched controls. All participants underwent hfCIMT and ufPWV measurements. hfCIMT and ufPWV measures of T1D were compared with controls and associations with age, sex, BMI, A1c, blood pressure, and lipids were studied.ResultsMean age was 24.1 years old in both groups. T1D had a greater body mass index (27.7 [5.7] vs 23.1 [3.2] kg/m2), LDL Cholesterol, and estimated GFR, and had a mean A1c of 7.4 [1.0] % (57 mmol/mol) and diabetes duration of 16.1 [3.7] years with 56% using insulin pumps. In T1D, hfCIMT was significantly increased as compared to controls (0.435 ± 0.06 mm vs 0.379 ± 0.06 mm respectively, p < 0.01). ufPWV measures were significantly increased in T1D (systolic foot PWV: 5.29 ± 0.23 m/s vs 5.50 ± 0.37 m/s, p < 0.01; dicrotic notch PWV = 7.54 ± 0.46 m/s vs 7.92 ± 0.41 m/s, p < 0.01). Further, there was an impact of A1c-measured glycemia on hfCIMT, but this relationship was not seen with ufPWV. No significant statistical correlations between hfCIMT and ufPWV measures in either T1D or healthy controls were observed.ConclusionYoung adults with T1D present with differences in arterial thickness and stiffness when compared with controls. Use of novel high-resolution ultrasound measures describe important relationships between early structural and vascular pathophysiologic changes and are promising tools to evaluate pre-clinical CVD risk in youth with T1D.Trial Registration: ISRCTN91419926.

Atrial fibrillation cryoablation guided by pressure waveform: a prospective multicentre registry

Abstract Background Cryoballoon ablation (CA) procedures require optimal occlusion of the pulmonary veins (PV), which is conventionally evaluated by iodine contrast injection through the catheter tip. This technique has some weaknesses such as risk of allergic reactions, nephrotoxicity, requirement of fluoroscopy (sometimes at high doses), requirement of a second operator, among others. PV pressure waveform assessment is an alternative method for confirming occlusion, however, multicentre assessment of periprocedural efficacy and safety is lacking. Purpose To describe the intra-procedural performance and safety of routine pressure-based CA. Methods In this independent prospective multicentre observational study, baseline and procedure data from consecutive pressure-guided CB ablations were collected. Operators were not required to have experience in pressure-guided CA for participating in the registry. They were asked to classify the pressure waveform curves into type 1 (presence of "a-wave" and/or symmetric "v-wave", meaning incomplete PV occlusion) and type 2 (absence of "a-wave" and asymmetric "v-wave", meaning complete PV occlusion), Figure 1. The primary endpoint was PV isolation in all veins without use of contrast. Procedure performance and adverse events were also analyzed. Results A total of 150 patients (mean age: 61 ± 10 y.) with paroxysmal (62%) or persistent AF (38%) were included and underwent pressure-guided CA in 9 centres from Spain. Complete PV isolation was achieved in 148 patients (98%). The operators switched to contrast use in 14 cases (9%), mainly to double check the occlusion. Total procedure and fluoroscopy time were 97 ± 39 and 19 ± 10 min respectively. There were 7 (4.7%) procedure related adverse events: 4 phrenic nerve palsy (3 of them were transient), 1 transient coronary ST elevation (before ablation), 1 gastroparesis and 1 femoral pseudoaneurysm. Most relevant results are summarized in Figure 2. Conclusion In this multicentre and multi-brand assessment, CA guided by pressure waveforms provided outstanding procedural outcomes, which were equivalent to those reported with the conventional approach. All operators could easily obtain and identify the waveform without a specific learning curve, avoiding the use of iodine contrast in most cases. The long-term efficacy of this approach will be presented in future analyses.Pressure waveforms types in cryoablationProcedural data

Volumetric quantification of epicardial fat using semiautomated atrial CT segmentation in patients with atrial fibrillation: the Prospective AFAT study

Abstract Background Epicardial fat or epicardial adipose tissue (EAT) is most commonly defined as adipose tissue between the myocardium and the visceral pericardium. Previous studies have suggested EAT to be an important contributor to the pathogenesis of atrial fibrillation (AF) as well as a plausible predictor for AF recurrences after ablation. However, data on EAT using precise volumetric quantification is limited. Methods and Results AFAT is a prospective observational study conducted at a heart centre in our city with 200 patients aimed to be included. We conducted an interim analysis of the first 75 patients enrolled in the AFAT study. All patients received delayed dual source cardiac computer tomography (CT) imaging which was analysed using semi-automated 3D segmentation (Figure 2) to quantify left atrial (LA) and right atrial (RA) EAT prior to ablation (52.5 % persistent AF). The mean age was 67 ± 8.7 years with 46.9 % (n=35) being female. Mean BMI was 28 ± 4.5. The Mean LA EAT was 33.1 ml ± 13.2 ml and RA EAT was 32.7 ml ± 12.2ml. Median follow up after AF catheter ablation was 163 days. The optimal cut point for the total atrial EAT was estimated at 50.2 ml. In patients with total atrial EAT ≤ 50 ml recurrence of any atrial arrythmia after catheter ablation occurred in 8% (6 patients) compared to 25.3% (19 patients) recurrence rates in patients with a total atrial EAT &amp;gt; 50 ml. Kaplan-Meyer estimates showed no statistical difference between groups (log rank p=0.063) as this analysis is under-powered with more patients being enrolled for the final results (Figure 1). Conclusion The use of semi-automated CT based atrial segmentation presents a novel highly accurate and reproducible method to reliably identify atrial EAT. Increased atrial EAT is likely to play an important role for arrythmia recurrences after catheter ablation. Final results of the AFAT study will provide further evidence to this important subject.Arrhythmia recurrences depending on EATBiatrial 3D Segmentation of EAT

A real-world prospective observational study of eptinezumab in Asian patients with migraine.

To evaluate the real-world effectiveness of eptinezumab for migraine prevention in Asian patients. Eptinezumab is a monoclonal antibody that targets calcitonin gene-related peptide (CGRP), a potent vasodilator with an important role in migraine pathophysiology. Although there is robust clinical evidence from pivotal Phase 3 placebo-controlled trials of the efficacy of eptinezumab for migraine prevention, there are limited data on the real-world effectiveness of eptinezumab in Asian patient cohorts. This was a non-interventional, prospective, multisite cohort study of adults with migraine (International Classification of Headache Disorders, 3rd edition criteria) in Singapore who were prescribed eptinezumab (100 mg at baseline and Month 3, administered intravenously) and were followed until Month 6. The primary endpoint was change from baseline in monthly migraine days (MMDs) at Month 3 and Month 6. Secondary endpoints were ≥30% and ≥50% responder rates, and change from baseline in the Headache Impact Test-6 (HIT-6), Migraine Disability Assessment (MIDAS), Migraine-Specific Quality of Life (MSQ), patient-identified most bothersome symptom (PI-MBS), acute medication use at Month 3 and Month 6, and safety. Enrolled patients (completed = 29/30) had on average 3.4 (SD 2.9) previous preventive treatments; 29/30 of the patients had trialed at least one previous preventive treatment without benefit. Most had previously trialed oral preventives (87%, 26/30) and anti-CGRP (70%, 21/30). Relative to baseline, mean MMDs decreased by 4.3 days (95% CI 2.1-6.4; p < 0.001) at Month 3 and 4.9 days (95% CI 2.1-7.7; p < 0.001) at Month 6. At Month 3 and Month 6, 14/30 (47%) and 15/29 (52%) of the patients were ≥30% responders, and 6/30 (20%) and 8/29 (28%) patients were ≥50% responders, respectively. The number of patients with severe life impairment based on the HIT-6 score (total score 60-78) decreased from 24/30 (80%) at baseline to 19/30 (63%) at Month 3 and 19/29 (66%) at Month 6. The mean MIDAS score decreased by 24.6 points (95% CI 2.82-46.38; p = 0.028) at Month 6, and the mean MSQ score increased by 12.2 points (95% CI 5.18-19.20; p = 0.001) at Month 3 and 13.6 points (95% CI 4.58-22.66; p = 0.004) at Month 6. Most patients reported improvement in the PI-MBS at Month 3 (73%, 22/30) and Month 6 (55%, 16/29). Acute medication use for headache relief decreased by 3.3 days/month (95% CI 1.0-5.6; p = 0.007) at Month 3 and 4.7 days/month (95% CI 1.7-7.7; p = 0.003) at Month 6. Treatment-emergent adverse events (TEAEs) were reported in 16/30 (54%) patients, mostly mild/moderate in severity. No serious TEAEs led to treatment discontinuation. Quarterly eptinezumab administration was effective and well-tolerated in Asian patients with chronic migraine.

Associations between atrial epicardial fat quantified by semi-automated CT segmentation and gender, BMI, cholesterol levels in AF patients: results from the prospective AFAT study

Abstract Background Epicardial adipose tissue (EAT) is defined as adipose tissue (epicardial fat) between the myocardium and the visceral pericardium. Recent evidence suggests that EAT may play important roles in regard to atrial fibrillation (AF) burden as well as other cardiovascular diseases through complex inflammatory mechanisms. Current evidence regarding the relationship of atrial EAT and BMI, gender or cardiovascular risk factors is mixed. Methods and Results We conducted a prospective observational study (AFAT) at the German Heart centre in Munich with 200 patients aimed to be included. This represents an interim analysis of the first 75 patients enrolled in the AFAT study. All patients received delayed dual source cardiac computer tomography (CT) imaging which was analysed using 3D segmentation (Figure 1) to quantify left atrial (LA) and right atrial (RA) EAT prior to receiving catheter ablation for AF. The mean age was 67 ± 8.7 years with 46.9 % being female (n=35) and the mean BMI was 28 ± 4.5. Mean LA EAT was 33.1 ml ± 13.2 ml and RA EAT was 32.7 ml ± 12.2ml with a total mean atrial EAT volume of 65.4 ml ± 10.2 ml. Volumes of the left- and right atrial EAT were significantly correlated in our sample (p &amp;lt; 0.001; Pearson correlation coefficient r=0.9). The mean total EAT Volume was significantly larger in males than in females (74 ml vs. 52 ml, p &amp;lt; 0.001) (Figure 2). Linear regression analysis adjusted for cofounders demonstrated significantly larger mean atrial EAT volumes in patients with higher body mass index (p = 0.001) and with increased age (p=0.006). Increased HbA1c levels or increased total cholesterol levels were not associated with higher total atrial EAT Levels (respectively, p=0.066 and p=0.22). Conclusion Semi-automated CT based atrial segmentation is a novel highly accurate and reproducible way to reliably identify atrial EAT. Left and right atrial EAT volumes are significantly intercorrelated. In this study BMI, Age and male gender were independently associated with higher EAT levels.Visualization of atrial EATGender differences in atrial EAT (ml)