Descriptive analysis of menstrual alterations reported to the Spanish pharmacovigilance system (SEFV as acronym of its name in Spanish) after vaccination against COVID-19

Objective: • To describe the most reported menstrual alterations to the SEFV in relation to vaccination against COVID-19. • To stratify cases by age, type of vaccine and reporter. • To collect the latencies of adverse events. Material and/or methods: Review of the notifications uploaded to the FEDRA database with the following search criteria: the suspected drug is a vaccine against COVID-19, the adverse drug reaction (ADR) is part of the Meddra HLGT “alterations of menstrual flow” and the upload date is between the date of authorisation of the first vaccine (22/12/20) and the cut-off date established by protocol (3/11/2021). Also, those cases corresponding to Canary Islands have been selected for a detailed analysis. Results: There are 2275 notifications in Spain that meet the search criteria. The SEFV is the source of 98% of the notifications, being the pharmaceutical industry the source of the 2% left. In Canary Islands, there have been 80 notifications that meet the criteria. Of these, 87.5% come from female users (patients). The average age is 36 years. The most reported menstrual disorders were “intermenstrual bleeding,” “menstrual disorder” and “irregular menstruation.” The latencies described have a mean of 12.5 days with a median of 6 days and a mode of 3 days, appearing after the first dose in most cases. Conclusions: Most of the reports are from female users. Coding is complex due to the difficulty of the terms, which complicates data analysis. Reported reactions are diverse, being the most frequent terms non-specific. Menstrual disturbances interfere with daily life, are underreported and under-diagnosed.

POS-319 TELENEPHROLOGY AS A PUBLIC POLICY FOR THE CARE OF PATIENTS WITH CKD AT THE PRIMARY HEALTH LEVEL. CHILEAN EXPERIENCE

Introduction: There are successful reports of the use of telemedicine in nephrology (TN), which would facilitate the access of patients with chronic kidney diseases (CKD) from the primary health centers (PHCs) to the nephrologist. Since 2019, TN has been implemented in Chile as a public health policy with national coverage. The process and outcome indicators associated with the Chilean National TN Program among PHCs and reference nephrologists are described. Methods: Descriptive study of asynchronous telemedicine care performed from urban and rural PHCs (574) (municipal health centers) to 17 nephrologists from Hospital Digital, between January 01, 2019 and June 30, 2021. The percentage of the rural population in Chile is 12.1%. Teleconsultations are sent by the PHCs doctor through a digital platform that contains clinical information, laboratory tests and treatments. The nephrologist in a deferred time, responds in the same way and decides between the options: 1) Counter-refer the patient to PHCs requesting more information or with treatment recommendations;2) Refer to a hospital for more complex studies or treatments. The following were analyzed: 1. Distribution by age, sex and comorbidities;2. Response times;3. Prevalence of CKD by stages;4. Destination post evaluation TN;5. Level of relevance of PHCs consultations. Results: In total, 12.705 asynchronous telemedicine visits were performed (2019: 50.8 %;2020: 31.9 %;2021:17.3%. During the Covid-19 pandemic, attention for TN was maintained although restricted by the health crisis in the public health network. The mean age was 65.9 (SD: 13.2) years;80% were older than 60 years;57%% women. CKD stages: S1 (8.5%%);S2 (16.2%);S3 (53.6%);S4 (17.9%) and S5 (3.7%). Comorbidities: diabetes 56%, hypertension 90.7%, dyslipidemia 65%, overweight 29.2% and obesity 38.7%. The average response time was 91 hrs. (range 1- 173). In total, 7.954 patients (62.6%) were referred to PHCs with recommendations, without requiring transfers to another center. In turn, 4.751 patients (37.4%) required face-to-face nephrological evaluation (58.1% high priority for CKD in stages 4-5). The relevance of the consultations according to the nephrologist's evaluation was considered high 23.1% and median 49.3%. Conclusions: The implementation of TN as a public policy has made it possible to facilitate expeditious access, evaluation and timely treatment of patients with CKD from urban and rural PHCs and prioritize face-to-face care by a nephrologist for those with greater risk or severity. Most of the patients evaluated (62.8%) were referred to PHCs, optimizing the limited space and high demand of face-to-face care per specialist. During the Covid-19 pandemic period, the use of TN was restricted but allowed continuity of control of patients with CKD and decongest PHCs and emergency care centers. Future studies should evaluate the impact of TN in the follow-up of patients screened with CKD, especially in stages 3-5, the decrease in travel-related CO2 emissions due to reduced displacement, the level of patient´s satisfaction/PHCs teams, and the evaluation effective cost of this care modality. No conflict of interest

Mental well-being among patients with congenital heart disease and heart failure during the COVID-19 pandemic

Patients with congenital heart disease (CHD) show increasing survival. We evaluated the influence of COVID-19 confinement on the mental well-being of patients with CHD. Descriptive, cross-sectional, observational epidemiological study in a cohort of 242 patients with CHD over 14 years old recruited consecutively from a single adolescent and adult CHD outpatient unit. Patients were sent an online questionnaire to determine clinical, demographic and the 12-element general health questionnaire (GHQ-12) data during the COVID-19 quarantine. 242 out of 407 (59%) patients with CHD, to whom the questionnaire was sent, responded to the survey. 98 (42%) patients were between 14 and 24 years old and 133 (58%) were over 25 years old. Of the total, 119 (51%) were male. 123 (51%), 88 (36%) and 31 (13%) patients with CHD had mild, moderate, and severe anatomical complexity respectively. 11 (4.5%) out of 242 patients with CC presented heart failure (HF) symptoms, requiring 18% of them admission to the hospital emergency department during the pandemic (P=0.002). In relation to the GHQ-12 questionnaire, patients with CHD and HF enjoyed less their daily activities (81% vs. 51%, P=0.043) and had less self-confidence (46% vs. 18%, P=0.041) than those without HF symptoms. In conclusion, patients with CHD and HF, during the COVID-19 quarantine, presented a lower capacity to enjoy daily activities and self-confidence than CHD without HF symptoms.

Covid-19 quarantine and depression in patients with congenital heart disease

COVID-19 outbreak has brought tremendous psychological pressure to the general population, especially to those with associated cardiovascular disease. An online Patient Health Questionnaire (PHQ-9) survey on consecutive congenital heart disease (CHD) patients, was carried out to determine depression during the Spanish coronavirus disease (COVID-19) quarantine. Two-hundred forty-two out of 407 (59%) CHD patients answered the survey, 123 (51%) had mild defects, 88 (36%) moderate and 31 (13%) great defects, most of them between 18 and 24 years old and 51% were male. Patients were dichotomized to no or mild (PHQ-9 < 10) and moderate to severe (≥ 10) depressive symptoms. Thirty-four (14%) patients showed a PHQ-9 ≥ 10 and 10 of them (29%) were under anxiolytic or antidepressant treatment during the quarantine. During the study period, 9 (4%) patients had COVID-19 symptoms. Patients with a NYHA above 2 (P=0.025), living in houses without garden or balcony (P=0.014), needing psychological/psychiatric evaluation/medication in the previous 12 months or being under anxiolytic/antidepres-sant treatment during the confinement had, significantly, a PHQ-9 score ≥ 10 (P < 0.001). Being under anxiolytic/ antidepressant treatment during the coronavirus pandemic [OR 3.92 (95% CI 1.05-14.66), P=0.043] and having previous psychological/psychiatric evaluation in the previous 12 months to the quarantine [OR 3.82 (95% CI 1.16-12.54), P=0.027] were the only variables that reached statistical significance, in the multivariable analysis, as predictors of a pathological PHQ-9 questionnaire (score ≥ 10). In conclusion depression was frequent during the COVID-19 quarantine among CHD patients, with only a third of them being under anxiolytic or antidepressant treat-ment. Needing psychological/psychiatric evaluation/treatment during the previous 12 months to the lockdown was a predictive factor for an abnormal PHQ-9 score.

COVID-19: from epidemiology to treatment.

The COVID-19 pandemic has greatly impacted the daily clinical practice of cardiologists and cardiovascular surgeons. Preparedness of health workers and health services is crucial to tackle the enormous challenge posed by SARS-CoV-2 in wards, operating theatres, intensive care units, and interventionist laboratories. This Clinical Review provides an overview of COVID-19 and focuses on relevant aspects on prevention and management for specialists within the cardiovascular field.