Adverse Events of Subcutaneous Loop Recorders: Insights from the MAUDE Database

Background: Complications using internal cardiac monitors are have been reported at a low rate. Targeted analyses of complications have not been well described. Objective: To investigate and describe complications associated with internal cardiac monitor (ICM) events reported to the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. Methods: Our team reviewed all reported events for the Reveal LINQ loop recorder submitted to the MAUDE database over seven years (1/1/2013-12/31/2019). A 5% random selection of reports was audited by two researchers to ensure report validity. Two cardiologists manually reviewed death and incongruent events for final interpretation. Results: 12,652 records were obtained during the observed time period. A total of 15,587 device complications were reported. Of this, under-sensing (n = 4509, 28.93%), premature discharge of battery (n = 3262, 20.93%), over-sensing (n = 2788, 17.89%), and other sensing issues (n = 1532, 9.83%) were most commonly reported. Patient adverse events were reported 1,030 times. Pain or discomfort (n = 275, 26.70%), site infection (n = 213, 20.68%), erosion (n = 138, 13.40%), and impaired healing (n = 49, 4.76%) were most commonly reported to affect patients. Death was reported four times; after expert review, no reports justified the device or procedure as a reasonable cause. Verification of events reported 99.53% accuracy of reporting. Conclusion: Several non-life-threatening ICM complications were commonly noted from the analysis. This study supports the safe use of ICMs. A better understanding of the complication profile will help providers select patients, provide informed consent, and expected management.

The Cognitive-Communication Checklist for Acquired Brain Injury: A Means of Identifying, Recording, and Tracking Communication Impairments

Purpose The communication service needs of individuals with acquired brain injuries (ABIs) are frequently overlooked, leading to delays, denials, or premature discharge from communication interventions. This is particularly true for those with subtle cognitive-communication deficits, which may not be apparent until sufficiently challenged at work, in school, or in the community. The purpose of this study was to evaluate a referral tool that could promote understanding of the broad range of communication impairments that occur following ABI and lead to improved identification and referral. Method This study evaluated the Cognitive-Communication Checklist for Acquired Brain Injury (CCCABI) through a survey. The CCCABI is a referral tool that summarizes 45 communication difficulties in 10 areas of cognitive-communication functioning. One hundred sixteen speech-language pathologists, 34 multidisciplinary referral sources, and 41 individuals with lived experience of brain injury were surveyed to evaluate the utility of this referral tool. Results The need for such a referral tool was endorsed by 96% of speech-language pathology respondents, 91% of multidisciplinary respondents, and 100% of respondents with lived experience of brain injury. Responses supported the CCCABI as a clear, comprehensive, and accessible tool for education and identification of the communication impairments that can occur after ABI. Conclusion The CCCABI is a means of increasing understanding of communication service needs following ABI in a manner that is accessible to individuals, families, program designers, funding sources, administrators, and multidisciplinary referral sources.

Constipation – actual problem in pregnancy

The objective: is to develop a complex program for the treatment of constipation in pregnant women, including the use of Probiotic.Materials and methods. 60 pregnant women were surveyed: 30 women of group I received the proposed treatment-and-prophylactic measures, and in 30 pregnant women of group II pregnancy was conducted by traditional methods.In order to improve the intestinal microflora of pregnant women of group I was prescribed: universal Probiotic 1 capsule per os 3 times per day for 30 days 2 courses – at 12–16 and 26–30 weeks of pregnancy.Results. In pregnant of group I increased the obligate flora with a decrease in their baseline, that is, only 10.0% of women of bifidobacteria did not exceed 105 CFU/ml and accordingly 6.7% indigenous lactoflora was less than 105 CFU/ml. At the same time, the number of women with reduced obligate flora who did not receive treatment for intestinal dysbiosis remained significantly higher (p<0.05).The number of pregnant with dysbiosis among women in group I (46.7 %) was significantly lower compared to women in group II (100.0%). The III degree of dysbiosis was not observed in any case with the proposed treatment, but it occurred in every third pregnant group II. Significant increase in the normal population of bifidobacteria and lactobacteria (105 and higher CFU/ml) was observed in pregnant women of group I. Symptoms of threat of termination of pregnancy in women of group II (20,0%), and in patients of group I – (10,0%). Premature discharge of amniotic fluid, was found to be significantly less frequent (23.3% versus 46.6% in group II, p<0.05).The threat of preterm birth was recorded in 10.0% of pregnant women in group II, and in group I in one woman (3.3%). Anemia was more common in group II than in pregnant group I (56.7% versus 26.7%). The decrease in the frequency of exacerbation of chronic and the occurrence of gestational pyelonephritis among pregnant women of the I group was determined.Conclusions. The conducted researches showed high efficiency of application of symbiotic of Probiotic for the purpose of normalization of evacuation function of intestine in pregnancy, normalization of intestinal microflora. This, in turn, helped to reduce the frequency of the threat of termination of pregnancy, premature discharge of amniotic fluid, premature birth, anemia, exacerbation of pyelonephritis.

Classifying discharge scenarios to improve understanding and care

Hospital discharge planning is valuable in improving care and avoiding discharge delays. This is highly relevant to older people. Although usual discharge planning is now well understood and applicable to most patients, a range of different discharge scenarios exist that involve different considerations. These less common scenarios appear less well understood and can be challenging for clinical staff. To improve understanding and care, this Commentary suggests a basic classification of six discharge planning scenarios. These are: usual discharge planning, premature discharge, rehabilitation selection, safety concerns, reluctant discharge and delayed discharge. Clinical and system responses to each scenario are briefly discussed. This classification could potentially be useful in clinical education and quality improvement.

Factors Affecting 72-Hour Unplanned Return Visits after Emergency Department Index Discharge of a Tertiary Private Hospital in the Philippines

Objectives. This study aimed to analyze if the indicator 72-hours Unplanned Return Visits after EmergencyDepartment (ED) index discharge was influenced by the patient’s age, triage severity, month, payment methods,and length of stay. Likewise, it aimed to determine if the 72-hour Unplanned Return Visits was a robust indicator inassessing the quality of Emergency Department services. Methods. This was a retrospective single-center study from January to December 2017. Data were retrievedfrom a tertiary hospital in the Philippines. All Emergency Department patients discharged on their index visitwere monitored for Unplanned Return Visits within 72 hours in the hospital. A univariate and multivariate logisticregression model was used to assess the variables associated with the 72-hour Unplanned Return Visits. Results. The 72-hour Unplanned Return Visits rate was measured at 2.67%, with the highest occurrence on thefirst 24 hours, and with predominance on third-party payer (p.<.0001), pediatrics (p.<0001), January (p<.0001),February (p<.0001), November (p<.0001), December (p<0001), and shorter length of stay (p<.0001) dischargedafter ED index visit. Conclusions. Strong association of Unplanned Return Visits during the first 72 hours after Emergency Departmentindex discharge was found for patients financed through third party-payers, with seasonal variations andinclination to the younger population with shorter length of stay. These findings warrant exploratory studies todetermine the reasons for the 72-hour Unplanned Return Visits after Emergency Department index discharge andinvestigation on the association of premature discharge, socio-economic, health structure, and illness progression.

Mental Health Outcomes of Premature Discharge from United States Air Force Basic Military Training

Introduction Each year, a substantial proportion of trainees who enter the U.S. Air Force (USAF) Basic Military Training (BMT) are unable to complete training. Reentry to civilian life poses significant challenges, including finding employment, establishing a new career path, and paying for education. To our knowledge, no study has examined the association of discharge from USAF BMT and mental health symptoms. Utilizing a sample of 85 individuals discharged from USAF BMT for reasons other than mental health concerns, the present study aimed to: (1) characterize the severity of current depression and anxiety symptoms; (2) examine the relationship between the severity of current depression and anxiety symptoms and sociodemographic variables; and (3) determine whether or not a trainee agreed with the decision to be discharged from BMT is associated with differing severities of depression or anxiety symptoms. Materials and Methods Participants were individuals who were prematurely discharged from USAF BMT for reasons other than mental health issues. Premature discharge is defined as any trainee who was unable to complete BMT in the USAF and was subsequently sent home. Participants were recruited from online Facebook groups for individuals who were prematurely discharged from USAF BMT. Participants were administered a battery of self-report questionnaires through a web-based survey platform. A structured demographic overview was administered to all participants to assess for age, gender, reason for discharge, amount of time spent in BMT, amount of time spent in medical hold, and whether or not the trainee agreed with the decision to be discharged. The Patient Health Questionnaire-9 (PHQ-9) was used to assess current symptoms consistent with depression. The Generalized Anxiety Disorder-7 (GAD-7) was used to assess current symptoms consistent with anxiety. Descriptive statistics were used to assess overall depression and anxiety rates, and analyses of covariance (ANCOVAs) were used to analyze group differences. This study was approved by the Institutional Review Board (IRB) at Florida State University (FSU). Results In total, 85 participants (42.4% = female) were accounted for in these data. Regarding depression symptom severity, 58.8% of participants (n = 50) indicated moderate or higher levels of depression symptoms. Regarding anxiety symptoms, 45.9% of participants (n = 39) indicated moderate or higher levels of anxiety symptoms. There were no significant differences reported regarding depression or anxiety symptoms across gender, age, amount of time spent in BMT, and amount of time spent in medical hold. Significant differences were found between depression and anxiety symptoms and whether or not a trainee agreed with the decision to be discharged from the USAF, such that trainees who did not agree with this decision reported higher levels of depression and anxiety symptoms. Conclusions The findings of this study indicate that this population of trainees who were prematurely discharged from USAF BMT for reasons other than mental health concerns has high levels of depression and anxiety symptoms. Discharge from BMT may be associated with substantial distress when the individual disagrees with the reason for discharge. Enhanced procedures and continued research regarding their postdischarge well-being seem warranted.