Symptomatic Episodes Research Articles

Is There any Association between Fecal Calprotectin Levels and Cystic Fibrosis?

Background: Early diagnosis of cystic fibrosis (CF) and hence the initiation of symptomatic and prophylactic treatment can help improve the outcomes of CF patients. Fecal calprotectin (FC) is a marker of inflammation in the intestinal tract that is elevated in several gastrointestinal inflammatory diseases, but little is known about its value in CF. Objectives: This study, therefore, aimed to survey the associations of FC among CF patients and its correlation with the clinical manifestations of CF. Methods: This descriptive cross-sectional study was performed on 52 children with CF visiting the Children’s Hospital of Tabriz, Iran, during 2018-2019, selected through the census sampling method. The calprotectin values of <50 μg/g were considered normal. Results: There was no clinically relevant association among FC levels concerning pancreatic insufficiency, diabetes, and airway colonization with Pseudomonas. In a comparison of the number of exacerbations and Forced Expiratory Volume in the first second (FEV1), the levels of electrolytes showed no significant difference between patients with normal calprotectin and elevated FC. The results of the performed analysis indicated no significant difference between the low-fecal elastase and the FC levels in patients with CF (P=0.53). Conclusion: Demographic and clinical parameters, such as age, gender, FEV1, or Body Mass Index, had no clinically significant relationship with FC. However, serial and longitudinal calprotectin levels should also be checked, which may have clinical relevance during symptomatic episodes.

Supraventricular arrhythmia following patent foramen ovale percutaneous closure

Abstract Background Randomized studies have reported low rates of atrial fibrillation (AF) after patent foramen ovale (PFO) closure (<6%) but have relied on patients-reported symptomatic episodes, thus true incidence and timing of AF after PFO closure remain unknown. Objective To prospectively determine the incidence, timing, and determinants of supraventricular arrhythmia following PFO closure based on loop recorder monitoring. Methods Cardiac monitoring was proposed to all patients after PFO closure from June 2018 to October 2021 in our center by mean of implantable loop recorder (ILR) monitoring in patients considered at higher risk of AF (age ≥55 years, associated cardiovascular risk factors, prior palpitations, or documented supraventricular ectopic activity) or 4-week external loop recorder (ELR) monitoring in other patients. The primary endpoint was the incidence of AF, flutter, or atrial tachycardia lasting >30 seconds within 28 days of the procedure. Determinants of the primary endpoint were assessed with stepwise logistic regression model. Results A total of 225 patients were included. The primary endpoint occurred in 47/225 (20.9%) patients, including n=13 (9.9%) and n=24 (28.9%) among ELR- and ILR-monitored patients, respectively. Among ILR-monitored patients, median follow-up was 428 (211–752) days, and four more cases of supraventricular arrhythmia were diagnosed beyond 28 days (Figure 1). Overall, median delay from procedure to arrhythmia was 14.0 (6.5–19.0) days and half of these patients reported symptomatic episodes. Determinants of the primary endpoint were older age (adjusted odds ratio [aOR]: 1.67, 95% confidence interval [CI]: 1.18–2.36, per 10-year increase), device left disc diameter ≥25mm (aOR: 2.67, 95% CI: 1.19–5.98) and male sex (aOR: 4.78, 95% CI: 1.96–11.66) (Figure 2). Conclusion Using prolonged loop recorder monitoring, supraventricular arrhythmia was diagnosed in one patient out of five with a median delay of 14 days suggesting that this post-procedural event has been so far, underestimated. Funding Acknowledgement Type of funding sources: None.

Linac-based stereotactic arrhythmia radioablation of paroxysmal atrial fibrillation in elderly patients

Abstract Background Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, occurring in 1–2% of the general population. Patients affected by AF have an increased risk of stroke and heart failure and European guidelines recommend catheter ablation of AF in symptomatic patients refractory to antiarrhythmic therapy. In elderly patients, the AF ablation procedure is associated with a higher rate of overall complications. Recently, stereotactic arrhythmia radioablation (STAR) with precise high-dose of radiation was used to treat ventricular arrhythmias. Purpose No data were reported in literature about the use of Linac-based STAR, so a prospective phase-II trial was designed to evaluate safety of Linac-based STAR in elderly patients with paroxysmal AF. Methods Fourteen patients (mean age 78±6 years; 57% male) were enrolled in the study. All patients had symptomatic paroxysmal AF refractory to antiarrhythmic drugs. All patients performed 1-week ECG-Holter monitoring (ECG-HM) and transthoracic echocardiogram before and after STAR. Primary end-point was defined as all the adverse events of special interest related to STAR treatment; secondary end-point was defined as AF recurrence after the treatment. The study was approved by the local Ethics Committee and all patients signed informed consent. Results All patients performed STAR with a mean overall treatment time of 3 minutes. No serious adverse events were documented acutely and after 6 months of follow up. Transthoracic echocardiogram did not show cardiac damage after STAR. The 1-week ECG-HM performed before STAR documented symptomatic AF episodes in all patients. The 1-week ECG-HM performed 1-month after procedure documented frequent symptomatic atrial ectopy and atrial tachycardias without AF recurrences. The 1-week ECG-HM performed 3 and 6 months after procedure did not revealed AF recurrences. Two patients had a single episode of sustained atrial tachycardia 6 months after STAR. Both patients performed a left atrial mapping using CARTO system and Pentaray mapping catheter documenting PV isolation without vein stenosis (figure); no phrenic nerve damage was documented in both patients. All patients had an improvement in quality of life. Conclusion Our preliminary data reported for the first time that the LINAC-based STAR approach could represent a valid alternative to perform PVI in elderly patients with paroxysmal AF. Funding Acknowledgement Type of funding sources: None.

Cardioneuroablation focused on the atrioventricular node: a comparison of right and left atrial approach

Abstract Background Radiofrequency catheter ablation of posteromedial left ganglionated plexus is a critical step to eliminate the vagal input to the atrioventricular node (AVN) for the treatment of symptomatic episodes of functional AV block. This ganglionated plexus can be effectively targeted from the coronary sinus (CS) or from the endocardial aspect of the right (RA) and left (LA) atria. Purpose We investigated the effect of ablation at individual sites on the suppression of parasympathetic modulation of AVN. Methods The study included 20 patients (age: 42±13 years, 45% males) who underwent cardioneuroablation in general anesthesia. Posteromedial left ganglionated plexus was ablated from [1] the CS (proximal 2-cm segment), [2] the RA aspect (between the fossa ovalis and inferior vena cava), and [3] the LA aspect (middle bottom part adjacent to inferior rim of fossa ovalis). Patients were randomly (1:1) assigned to CS-to-RA or RA-to-CS ablation order. LA ablation was always the last step. The response to extracardiac vagus nerve stimulation (ECVS; 50 Hz, 0.05 ms, 1 V/kg [<70V], 5 s) while atrial pacing (100 bpm) was recorded at baseline and after each ablation step. The number of non-AV-conducted beats during the ECVS was considered a measure of AV nodal denervation. Both right and left vagus nerves were sequentially stimulated and the stronger response of the AV node was taken into account. Results Temporal development of outcome measure with the progression of ablation is shown in Figure 1. CS ablation resulted in much stronger AV nodal denervation compared to RA ablation (P=0.02). However, RA ablation still provided some effect on top of CS ablation. The combination of CS + RA ablation resulted in complete AVN denervation in 8 (40%) patients. Subsequent LA ablation increased the number of denervated patients to 14 (70%). Two more patients were subsequently denervated by ablation elsewhere. In four patients, AVN denervation was not achieved but their responsiveness to ECVS was significantly suppressed compared to the baseline. Conclusions All ablation clusters targeting posteromedial ganglionated plexus convey complementary effects. Biatrial cardioneuroablation seems essential for efficacious suppression of parasympathetic modulation of AVN. Funding Acknowledgement Type of funding sources: None.

Efficacy and safety of empagliflozin in people with type 2 diabetes during Ramadan fasting

Background and aimsTo explore efficacy and safety of empagliflozin in people with type2 diabetes during Ramadan fasting MethodsPeople with type2 diabetes (T2DM) who were taking empagliflozin and sulphonylurea with or without a metformin and dipeptidyl peptidase inhibitors (DPP4) recruited a month before Ramadan. Glycated hemoglobin (HbA1c) and estimated glomerular filtration rate (eGFR) were recorded pre- and post-Ramadan. A predesigned diary was given to the participants to keep track of their T2DM status during Ramadan. The proportion of the people who had hypoglycaemia, or any adverse event related to the study drug was assessed after-Ramadan. ResultsA total of 116 participants completed the study. Symptomatic episodes of hypoglycaemia were more common among people who used sulphonylurea (i.e., 8.6%). Genitourinary infections and volume depletion events were recorded more in people on empagliflozin i.e., (6.9% and 5.17%, respectively). A significant reduction in body mass index (BMI), and HbA1c was noted among people on empagliflozin post Ramadan. A significant reduction in eGFR was noted only in people who were taking empagliflozin in combination with metformin. ConclusionEmpagliflozin was found to be safe and effective in fasting people with T2DM. Further large-scale studies are needed to validate our findings.

Prophylactic Dose of Dalteparin in Pregnant Women With History of Venous Thromboembolisms and/or Thrombophilia: Real-World Data.

Women with a history of venous thromboembolisms (VTEs) and/or thrombophilia are at increased risk of VTE during pregnancy. We analysed our cohort of such women who were treated with a prophylactic doses of dalteparin. 152 pregnant women with 179 pregnancies were classified into 3 groups: (1) previous VTE without thrombophilia (122 pregnancies); (2) previous VTE with thrombophilia (26 pregnancies) and (3) thrombophilia only (31 pregnancies). They were treated with prophylactic dalteparin in the prepartum and postpartum periods or only in the postpartum period. Occurrences of symptomatic VTE and bleeding episodes were followed, as well as dalteparin discontinuation and anti-Xa activity. Symptomatic deep vein thrombosis occurred in 4 women (2.2%) with 2 episodes in group 1 (in the postpartum period) and 2 episodes in group 2 (one in the prepartum and another in the postpartum period). Seven episodes (3.9%) of minor bleeding occurred. Dalteparin was not stopped in any women. Anti-Xa levels were within the prophylactic range. Our real-world data show a low incidence of thrombosis and minor bleeding in pregnant women treated with prophylactic dalteparin. The incidence of recurrent VTE was lower than that reported in women with similar risk, but without prophylactic anticoagulation.

Large vessel occlusions requiring repeated mechanical thrombectomy caused by silent myocardial infarction in a young adult

ObjectivesSilent myocardial ischemia, defined as objective evidence of myocardial ischemia without symptoms, is associated with ischemic stroke. Nevertheless, silent myocardial infarction is a rare cause of ischemic stroke, especially in young adults with no medical history. Materials and methodsHerein, we report a young adult patient with acute ischemic stroke treated with repeated mechanical thrombectomy for recurrent large vessel occlusions caused by left ventricular thrombus following a silent myocardial infarction. ResultsA 40-year-old man was transferred by ambulance to our hospital because of a generalized seizure. He was diagnosed with cerebral infarction and left middle cerebral artery occlusion. We performed intravenous thrombolysis and mechanical thrombectomy. Recanalization was achieved and his symptoms gradually improved. However, the day after treatment he developed bilateral cerebellar infarction and basilar artery occlusion. We performed a second mechanical thrombectomy and recanalization was achieved. Transthoracic echocardiography revealed a mobile left ventricular thrombus. Although he had no previous chest symptomatic episodes, cardiac examination confirmed myocardial infarction of unknown onset. He was diagnosed with acute ischemic stroke with large vessel occlusions caused by left ventricular thrombus following a silent myocardial infarction. Anticoagulation therapy reduced the amount of thrombus. At 1-year follow-up, he had not experienced any recurrences or symptoms. ConclusionsSilent myocardial infarction should be considered a cause of ischemic stroke in young adults, even without any vascular risk factors. Recurrent large vessel occlusion may occur in patients with left ventricular thrombus, and repeated mechanical thrombectomy should be considered for treatment.

Insulinoma-related Endogenous Hypoglycaemia with a Negative Fasting Test: A Case Report and Literature Review.

We present the case of a patient with a history of symptomatic hypoglycaemic episodes and a negative 72-hour fasting test with histological confirmation of insulinoma. A literature review of hyperinsulinaemic hypoglycaemia with a negative fasting test was performed.LEARNING POINTSThe 72-hour fasting test is the gold standard for insulinoma diagnosis.Few cases of insulinoma with a negative fasting test have been reported.New strategies for insulinoma diagnosis are being investigated.

Composite Index Tagging for PVIinParoxysmal AF: A Prospective, Multicenter Postapproval Study.

VISITAG SURPOINT (VS)-guided ablation of paroxysmal atrial fibrillation has demonstrated good short- and long-term success rates with low rates of complications in recent, predominantly European, studies. However, there is a lack of multicenter data from the United States. This U.S. study evaluated the safety and effectiveness of VS ablation using a contact force-sensing catheter for the treatment of drug-refractory symptomatic paroxysmal atrial fibrillation. The prospective, nonrandomized VS postapproval study was conducted at 32 U.S. sites. Ablation consisted of pulmonary vein isolation with recommended VS index targets (anterior, roof, or ridge: 550; posterior or inferior: 380). Additional non-pulmonary vein triggers were ablated at the investigators' discretion. Subjects were followed for 12months, including a 3-month blanking period. The primary safety endpoint was the primary adverse event rate up to 7days postablation. The primary effectiveness endpoint was 12-month freedom from atrial tachyarrhythmia recurrence and an additional set of failure modes based on stringent monitoring (weekly transtelephonic monitoring [TTM] [day 91 through month 5], monthly TTM [months 6 to 12], and any symptomatic cardiac episode using TTM, plus electrocardiogram [atdischarge, 1month, 3months, 6months, and 12months] with 24-hour Holter monitoring [12months]). Of 283 patients enrolled, 261 had the catheter inserted and underwent ablation (safety cohort); 246 metall eligibility criteria (effectiveness cohort). Mean fluoroscopy time was 2.2minutes. Mean amount of catheter-delivered fluid was 671mL; only 18.0% of patients utilized a Foley catheter. Primary safety and effectiveness endpoints were met. The raw primary adverse event rate was 4.3% (14 events, n=11). At 12months, the Kaplan-Meier estimate of freedom from primary effectiveness failure was 76.4%; estimates of 12-month freedom from documented atrial fibrillation, atrial tachycardia, or atrial flutter recurrence were 81.5% and 92.7% per stringent monitoring and standard-of-care monitoring (excluding TTM), respectively. The first-pass isolation rate was 83.1%, represented by no acute reconnection after the 30-minute waiting period. Freedom from repeat ablation at 12months was 94.0%. The VS postapproval study confirms reproducibility of clinical safety and effectiveness of the standardized VS paroxysmal atrial fibrillation ablation workflow with >80% 12-month freedom from atrial tachyarrhythmia recurrence and first-pass isolation rate of 83.1%. Procedures were performed with minimal fluoroscopy. (Evaluation of VISITAG SURPOINT™ Module With External Processing Unit [EPU]; NCT03624881).

Supraventricular Arrhythmia Following Patent Foramen Ovale Percutaneous Closure

BackgroundRandomized studies have reported low rates of atrial fibrillation (AF) after patent foramen ovale (PFO) closure (<6%) but have relied on patient-reported symptomatic episodes, so the true incidence and timing of AF after PFO closure remain unknown. ObjectivesThe aim of this study was to prospectively determine the incidence, timing, and determinants of supraventricular arrhythmia following PFO closure on the basis of loop recorder monitoring. MethodsCardiac monitoring was proposed to all patients after PFO closure from June 2018 to October 2021 at a single center by means of implantable loop recorder monitoring in patients considered at higher risk for AF (age ≥ 55 years, associated cardiovascular risk factors, prior palpitations, or documented supraventricular ectopic activity) or 4-week external loop recorder monitoring in other patients. The primary endpoint was the incidence of AF, atrial flutter, or supraventricular tachycardia lasting >30 seconds within 28 days of the procedure. Determinants of the primary endpoint were assessed using a stepwise logistic regression model. ResultsA total of 225 patients were included. The primary endpoint occurred in 47 patients (20.9%), including 13 (9.9%) and 24 (28.9%) among patients monitored with external loop recorders and implantable loop recorders, respectively. Overall, the median delay from procedure to arrhythmia was 14.0 days (IQR: 6.5-19.0 days), and one-half of these patients reported symptomatic episodes. Determinants of the primary endpoint were older age (adjusted OR: 1.67 per 10-year increase; 95% CI: 1.18-2.36), device left disc diameter ≥25 mm (adjusted OR: 2.67; 95% CI: 1.19-5.98) and male sex (adjusted OR: 4.78; 95% CI: 1.96-11.66). ConclusionsUsing loop recorder monitoring for ≥28 days, supraventricular arrhythmia was diagnosed in 1 in 5 patients, with a median delay of 14 days, suggesting that this postprocedural event has so far been underestimated.

Clinical Characteristics and Outcome Related to Blood Eosinophilic Chronic Obstructive Pulmonary Disease (COPD) Patients.

IntroductionThe term chronic obstructive pulmonary disease (COPD) refers to a range of illnesses that impair breathing and airflow. Clinical history of COPD is further impacted by frequent exacerbations known as acute exacerbation COPD in which these specific symptoms worsen contributing to emergency room (ER) visits and hospitalization. Blood eosinophils are a crucial indicator of therapy effectiveness and exacerbation rate. The role of blood eosinophils as a biomarker for treatment, response, exacerbation risk, inflammation, and other symptoms in COPD patients is implemented by the Global Initiative Obstructive Lung Disease (GOLD) as guidelines.ObjectiveTo determine the clinical characteristics and outcomes related specifically to eosinophilic COPD Patients.MethodologyThis is a retrospective single-center study of all AECOPD presented at ET between 2018 to 2019. A total of 120 patients were included. Patients were divided into two groups depending on blood eosinophil count: high (>300cells/µL) and low (<300cell/µL). Finally, Binary logistics regression was performed to determine correlations between clinical characteristics and eosinophil count levels.ResultsIn the high eosinophil patients’ group: none of the independent variables were statistically significant. However, in the low eosinophil patients’ group: ER visits, lung disease, and symptomatic exacerbation made a statically significant contribution to the model (p-value of .008, .01, .001) respectively.Conclusion and recommendationThe higher eosinophil levels showed better clinical outcomes compared to lower eosinophil levels. Increasing the level of symptomatic AECOPD episodes in low eosinophil levels may be linked to the onset of bacterial infection and airway inflammation. The study further recommends a prospective cross-sectional multi-center study which includes a follow-up of the patients to assess the number of exacerbations after initial treatment

At-home ECG monitoring with a real-time outpatient cardiac telemetry system during the COVID-19 pandemic.

During the COVID-19 pandemic, essential in-person electrocardiogram (ECG) recordings became unfeasible, while patients continued to suffer from cardiac conditions. To circumvent these challenges, the cardiology clinic (Long Island Heart Rhythm Center [LIHRC]) at the New York Institute of Technology College of Osteopathic Medicine (NYITCOM) transitioned to a remote real-time outpatient cardiac telemetry (ROCT) service. The goal of this study is to test the hypothesis that at-home ROCT, provided by the LIHRC, is an effective method of providing ECG monitoring to symptomatic patients during the COVID-19 pandemic. Seventeen patients at the LIHRC that required ECGs between March 11 and August 1, 2020, were included in this study. The patients' medical records were de-identified and reviewed for age, gender, ROCT indications, findings, patient comfort, and ease of use. A retrospective analysis of observational de-identified data obtained from the LIHRC was approved and permitted by the NYITCOM Institutional Review Board (BHS-1465). These FDA-cleared medical devices (DMS-300, DM Software, Stateline, NV) were shipped to the patients' homes and were self-applied through adhesive chest patches. The devices communicated with a cloud-based system that produced reports including a continuous 6-lead ECG and many other cardiovascular parameters. Additionally, a patient-activated symptom recorder was available to correlate symptoms to ECG findings. Seventeen patients (15 women) from the LIHRC were included in the analysis with an average monitoring duration of 27h (range, 24-72h). The patients' ages ranged from 21 to 85years old with a mean of 37years old and a standard deviation of 19. ROCT indications included palpitations (n=9), presyncope (n=8), chest pain (n=5), syncope (n=3), and shortness of breath (n=2). One also received ROCT due to short PR intervals observed on a prepandemic ECG. Two patients experienced palpitations while wearing the ROCT device: one had supraventricular tachycardia at 150 beats per minute; the other had unifocal premature ventricular contractions (PVCs) and eventually underwent a successful cardiac ablation. Most patients experienced no symptomatic episodes during ROCT (n=15). The 6-lead ROCT ECG for five of those patients showed arrhythmias including wandering atrial pacemaker (n=2), PVCs (n=2), sinus tachycardia (n=1), premature atrial contractions (PACs) (n=1), ectopic atrial rhythms (n=1), and sinus arrhythmia (n=1). One patient who experienced issues with our device was able to obtain a device from a separate clinic and was found to have bradycardia, PVCs, and nonsustained ventricular tachycardia. Overall, 16/17 (94.1%) patients were monitored effectively with the LIHRC ROCT system, and all (17/17, 100%) patients were monitored effectively with a ROCT system either from the LIHRC or a separate clinic. With the unique challenges of the COVID-19 pandemic, physicians can use this innovative ROCT method to prevent infection and diagnose cardiac diseases. Most patients and staff were able to utilize the system without issues. Therefore, this system may also be utilized to deliver patient-centered care to those with limited mobility when coupled with a telemedicine visit.

Artificial intelligence augments detection accuracy of cardiac insertable cardiac monitors: Results from a pilot prospective observational study

BackgroundInsertable cardiac monitors (ICMs) are indicated for long-term monitoring of patients with unexplained syncope or who are at risk for cardiac arrhythmias. The volume of ICM-transmitted information may result in long data review times to identify true and clinically relevant arrhythmias.ObjectiveThe purpose of this study was to evaluate whether artificial intelligence (AI) may improve ICM detection accuracy.MethodsWe performed a retrospective analysis of consecutive patients implanted with the Confirm RxTM ICM (Abbott) and followed in a prospective observational study. This device continuously monitors subcutaneous electrocardiograms (SECGs) and transmits to clinicians information about detected arrhythmias and patient-activated symptomatic episodes. All SECGs were classified by expert electrophysiologists and by the WillemTM AI algorithm (IDOVEN).ResultsDuring mean follow-up of 23 months, of 20 ICM patients (mean age 68 ± 12 years; 50% women), 19 had 2261 SECGs recordings associated with cardiac arrhythmia detections or patient symptoms. True arrhythmias occurred in 11 patients: asystoles in 2, bradycardias in 3, ventricular tachycardias in 4, and atrial tachyarrhythmias (atrial tachycardia/atrial fibrillation [AT/AF]) in 10; with 6 patients having >1 arrhythmia type. AI algorithm overall accuracy for arrhythmia classification was 95.4%, with 97.19% sensitivity, 94.52% specificity, 89.74% positive predictive value, and 98.55% negative predictive value. Application of AI would have reduced the number of false-positive results by 98.0% overall: 94.0% for AT/AF, 87.5% for ventricular tachycardia, 99.5% for bradycardia, and 98.8% for asystole.ConclusionApplication of AI to ICM-detected episodes is associated with high classification accuracy and may significantly reduce health care staff workload by triaging ICM data.

Predictors of initial oral food challenge outcome in food protein-induced enterocolitis syndrome.

There is a paucity of data on predictors of clinical history in oral food challenge (OFC) outcome for the initial diagnosis of food protein-induced enterocolitis syndrome (FPIES). This study aimed to identify predictors for the diagnosis of FPIES. The study included patients who underwent OFC to diagnose FPIES from 2010 to 2021. Patients with a positive OFC result were classified as belonging to the FPIES group, and those with negative OFC result within 120 days from the last symptomatic episode were classified as belonging to the no-allergy (NA) group. Background factors were analyzed in the groups. A total of 50 OFCs to 12 different foods were conducted in 50 patients. Of those 50 patients, 30 were classified as belonging to the FPIES group. No significant difference was observed between the FPIES and NA groups with respect to background factors, including the features of symptomatic episodes and examinations of immediate-type allergy. Ahistory of asymptomatic ingestion was observed in 23 of 24 and 13 of 19 patients in the FPIES and NA groups, respectively; thus, it was significantly more common in patients with FPIES. The diagnostic rate of patients with fewer than 3 symptomatic episodes was 52%, and that of patients with 3 episodes or more was 75%, not considering a patient without available data. A definite diagnosis of FPIES should be based on OFC, as there are no predictors for OFC positivity other than a history of asymptomatic ingestion. The absence of asymptomatic ingestion history was a negative predictor for the diagnosis of FPIES.

Effectiveness of redcore lotion in patients with vulvovaginal candidiasis: a systematic review and Meta-analysis.

To summarize and evaluate the effectiveness and safety of Redcore lotion on treating vulvovaginal candidiasis (VVC) using a systematic review and Meta-analysis of randomized controlled trials. A systematic literature search was performed in five English and three Chinese electronic databases up to October 2019. Randomized controlled trials in the treatment for VVC were included; only studies which compared the effectiveness and safety of Redcore lotion plus miconazole with miconazole alone were included. Relative risk (RR) and 95% confidence intervals (CI) were used in the Meta-analysis. Seven studies involving 768 patients suffering from VVC were identified; 468 of the patients were pregnant women (60.9%). Combination group (Redcore lotion plus miconazole) was more effective in reduCIng symptomatic episodes of VVC than miconazole alone, with respect to cure rate (RR, 1.31; 95% CI, 1.09-1.57; P = 0.01), fungal culture negative rate (RR, 1.21; 95% CI, 1.04-1.41; P = 0.01), and effective rate (RR, 1.18; 95% CI, 1.05-1.35; P = 0.01). Subgroup analyses for pregnant women also showed that the combination group had superior outcomes with respect to VVC cure rate (RR, 1.48; 95% CI, 1.16-1.88, P < 0.01), fungal culture negative rate (RR, 1.26; 95% CI; 1.09-1.47; P < 0.01), and effective rate (RR, 1.25; 95% CI, 1.10-1.42; P < 0.01). Additionally, the observed risk of adverse events was lower in the combination medication group (RR, 0.30; 95% CI, 0.14-0.65; P < 0.01). Though overall quality of individual studies was low, Redcore lotion plus miconazole can significantly improve clinical effectiveness and safety compared with miconazole alone.

Skin sympathetic nerve activity in patients with chronic orthostatic intolerance.

Chronic orthostatic intolerance (OI) is characterizedby the development of tachycardia and other symptomswhen assuming an upright body position. The purpose of this study was to test the hypothesis that skin sympathetic nerve activity (SKNA) bursts are specific symptomatic biomarkers in patients with chronic OI. We used an electrocardiogram monitor with a built-in triaxial accelerometer to simultaneously record SKNA and posture in ambulatory participants. Study 1 compared chronic OI (14 women and 2 men; mean age 35 ± 10 years) with reference control participants (14 women; mean age 31 ± 6 years). Study 2 included 17 participants with chronic OI (15 women and 2 men; mean age 39 ± 12 years) not yet treated with ivabradine, pyridostigmine, or β-blockers. In study 1, there were 124 episodes (8 ± 4 per participant) of postural changes, with 11 episodes (8.9%) associated with symptoms. In comparison, 0 of 104 postural changes (7 ± 3 per participant) in controls were symptomatic (P = .0011). In participants with chronic OI, the SKNA bursts associated with symptomshad higher burst frequencies, longer burst durations, and larger mean burst areas than did bursts during asymptomatic periods. However, SKNA bursts and tachycardia were asymptomaticin controls. We analyzed 110 symptomatic episodes in study 2 (6 ± 5 per participant). Among them, 98 (89.1%) followed at least 1 SKNA burst. In comparison, only 41 (37.3%) had heart rate exceed 100 beats/min 1 minute before symptom onset (P < .0001). SKNA bursts are a highly specific, albeit insensitive, symptomatic biomarker for chronic OI.

Endoscopic sigmoidopexy for recurrent sigmoid volvulus in inoperable patients: a retrospective series of 15 patients.

Recurrent sigmoid volvulus is frequent and sometimes occurs in frail patients with contraindications to surgical sigmoidectomy. Percutaneous endoscopic sigmoidopexy (PES) has recently been proposed as an alternative to elective sigmoidectomy. We aimed to describe the efficacy and safety of PES. All consecutive patients who underwent PES for recurrent sigmoid volvulus at two French centers between January 2017 and March 2021 were included in this retrospective case series. Recurrent sigmoid volvulus was defined as at least two symptomatic episodes treated by endoscopic decompression. Under endoscopic guidance, anchors were placed to attach the sigmoid to the anterior abdominal wall, allowing the placement of pigtail Chait catheters. 15 patients (60 % female; median age 74 years [range 49-96]) were included. Median number of previous sigmoid volvulus episodes was 3 (range 2-6). Procedures were technically successful with no intraprocedural adverse events for 14 patients (93 %). Peritonitis occurred at Day 2 in one patient (serious adverse event rate 7 %). Median follow-up time was 10 months (range 1-30). No sigmoid volvulus recurrence occurred during follow-up. PES using Chait catheters was feasible and effective for recurrent sigmoid volvulus and should be considered as an alternative to sigmoidectomy in inoperable patients.

689-P: Comparing the Rates of Sensor-Detected Hypoglycaemia and Patient-Reported Hypoglycaemia by Awareness of Hypoglycaemia Using Continuous Glucose Monitoring: The Hypo-METRICS Trial

Impaired awareness of hypoglycemia (IAH) is attributed to hypoglycemia exposure. Continuous glucose monitoring (CGM) detects more hypoglycemia particularly during sleep. We compared rates and duration of sensor detected hypoglycemia (SDH) and patient reported hypoglycemia (PRH) in people with type 1 diabetes (T1D) using CGM or flash monitoring.We recruited 92 participants with T1D using CGM/Flash reporting &amp;gt;1 hypoglycemic episode in the last month. Participants were defined as normal awareness of hypoglycemia (NAH) (Gold score &amp;lt;4; n=70) and IAH (Gold score &amp;gt;4; n=22) . All wore an additional blinded CGM and recorded episodes of PRH (symptomatic episodes that resolved on carbohydrate ingestion, or a measured glucose &amp;lt;72mg/dl) in real time on a smartphone app for weeks. Sleep status was obtained using an actigraphy monitor. Time in range (59.4 vs. 62.4%; p=0.18) and time &amp;lt; 70 mg/dl (4.6 vs. 6.0%; p=0.44) were not different between groups. Rates and duration of SDH &amp;lt; 70 mg/dl, &amp;lt; 55 mg/dl and &amp;lt; 40 mg/dl during sleep and awake were not different (table 1) . Rates of PRH were also not different (table 1) . While CGM has benefits, it cannot be used to define IAH. CGM allows people with IAH to self-detect hypoglycemia similar to those with NAH, providing a technology supported awareness. Disclosure P.Divilly: None. S.R.Heller: Advisory Panel; Eli Lilly and Company, Medtronic, Mylan N.V., Zealand Pharma A/S, Zucara Therapeutics, Other Relationship; Eli Lilly and Company, Research Support; Dexcom, Inc., Speaker’s Bureau; Novo Nordisk A/S. M.Evans: Advisory Panel; Pila Pharma, Zucara Therapeutics, Other Relationship; Abbott Diabetes, Dexcom, Inc., Medtronic, Novo Nordisk, Research Support; AstraZeneca, Sanofi, Speaker’s Bureau; Lilly Diabetes. J.K.Mader: Advisory Panel; Abbott Diabetes, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Medtronic, Merck Sharp &amp; Dohme Corp., Novo Nordisk A/S, Roche Diabetes Care, Sanofi-Aventis Deutschland GmbH, Speaker’s Bureau; Abbott Diabetes, Eli Lilly and Company, Medtronic, Merck Sharp &amp; Dohme Corp., Novo Nordisk A/S, Roche Diabetes Care, Sanofi-Aventis Deutschland GmbH, Servier Laboratories, Stock/Shareholder; decide Clinical Software GmbH. S.A.Amiel: Advisory Panel; Medtronic, Novo Nordisk, Other Relationship; Sanofi. P.Choudhary: Advisory Panel; Abbott Diabetes, Lilly Diabetes, Medtronic, Research Support; Novo Nordisk, Speaker’s Bureau; Dexcom, Inc., Glooko, Inc., Insulet Corporation, Sanofi. A.Seibold: Employee; Abbott Diabetes, Stock/Shareholder; Abbott. G.Martine-edith: Other Relationship; Novo Nordisk. Z.Mahmoudi: Employee; Novo Nordisk A/S. N.Zaremba: None. U.Soeholm: Research Support; Novo Nordisk A/S. U.Pedersen-bjergaard: Advisory Panel; Novo Nordisk A/S, Sanofi. R.J.Mccrimmon: Advisory Panel; Novo Nordisk, Sanofi, Research Support; Diabetes UK, European Union, MedImmune. B.E.De galan: Research Support; Novo Nordisk. E.Renard: Consultant; Abbott, AstraZeneca, Boehringer Ingelheim International GmbH, Dexcom, Inc., Insulet Corporation, LifeScan, Lilly, Novo Nordisk, Roche Diabetes Care, Sanofi, Tandem Diabetes Care, Inc. Funding Innovative Medicines Initiative (777460)

EVALUATION OF ATRIAL FIBRILLATION BURDEN AFTER THE FIRST ECG-DOCUMENTED EPISODE VIA IMPLANTABLE LOOP RECORDERS

Objective: The natural history of paroxysmal atrial fibrillation (AF) after the first clinical AF episode is not well known. AF burden is of clinical significance as it may have clinical implications concerning the long-term management of the arrhythmia and the decision-making on AF patients. We studied the natural history of AF in patients after their first clinical AF episode. Design and method: Thirty consecutive patients (age 66.9 ± 10 years; 14 men) received an implantable loop recorder (ILR) (Reveal XT 9529; Medtronic, Minneapolis, Minnesota, USA) after their first symptomatic paroxysmal AF episode. We recorded the AF recurrences and burden (clinical and subclinical AF) during a follow-up period of three years. We excluded patients with persistent or permanent AF and patients with AF attributed to reversible or transient causes. Results: Eight patients (26.6%) did not present any AF recurrence during the first year of the follow-up period. Five patients (16.6%) did not also suffer any AF episode during the second year, while in three patients (10%) no AF episode was recorded during the three-year follow-up period. In 16 patients (53.3%) the AF burden was increased during the second year of follow-up period while in 9 patients (30%) the AF burden was decreased. During the third year of follow-up period the AF burden was increased in 19 patients (63.3%), decreased in 7 patients (23.3%) and remained almost the same in 4 patients (13.3%). Five patients (16.6%) presented at least one episode of persistent AF during the follow-up period. Seven patients (23.3%) suffered only from symptomatic AF episodes, while in nine patients (30%) only asymptomatic AF episodes were recorded. Eleven patients (36.7%) had both types of AF episodes (symptomatic and asymptomatic). Conclusions: The AF recurrences and burden increased in most AF patients during the three-year follow-up period. However, some patients did not suffer any AF recurrence or they presented a decrease in AF burden. Paroxysmal AF clinical profile differs among the AF patients significantly and this indicates that an individualized approach via long-term rhythm monitoring may be of clinical significance, at least in some newly diagnosed AF patients.

Clinical Characteristics and Outcomes of Patients With SARS-CoV-2 Reinfection

ObjectiveTo examine the clinical characteristics, risk of hospitalization, and mortality of patients diagnosed with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) reinfection. Patients and MethodsWe retrospectively reviewed all patients with SARS-CoV-2 reinfection at all Mayo Clinic sites between May 23, 2020, and June 30, 2021 (the period before the emergence of the Delta variant in the United States). The reinfection was defined as a positive SARS-CoV-2 test more than or equal to 90 days after initial infection or 45-89 days after with symptomatic second episode. Vaccination status was classified as fully vaccinated, first dose, and unvaccinated. Comparative analysis of baseline characteristics and comorbidities was performed by hospitalization and vaccination status. The survival analysis of the hospitalized patients was performed using Cox proportional hazard regression. ResultsAmong the 554 patients reinfected with SARS-CoV-2, 59 (10.6%) were pediatric, and 495 (89.4%) were adults. The median age was 13.9 years (interquartile range, 8.5-16.5 years) for the pediatric and 50.2 years (interquartile range, 28.4-65.6 years) for the adult population. Among the adult patients, the majority were unvaccinated (83.4%, n=413), and the duration to reinfection from initial infection was the longest in the fully vaccinated group (P<.001). Forty-two (75%) out of 56 patients were seropositive within 7 days of reinfection. In hospitalized adult patients, Charlson Comorbidity Index was an independent risk factor for mortality (adjusted hazard ratio, 0.35; 95% CI, 0.19-0.51). ConclusionIn this study, most adult patients with SARS-CoV-2 reinfection were unvaccinated. Furthermore, the duration to reinfection was longest in fully vaccinated individuals. Seropositivity was common among adult patients.