RESUMEN
Background: Adults with congenital heart disease (ACHD) are considered at increased risk for complications due to COVID-19, especially in those with cyanosis or heart failure. However, data regarding the rate of infection as well as regarding a myocardial involvement of a COVID-19 infection in ACHD patients are currently lacking. Purpose(s): To study the rate of COVID-19 infections in ACHD patients from a tertiary centre as well as the rate of myocardial involvement of a COVID- 19 infection. Method(s): All consecutive ACHD patients (over the age of 18 years) who attended the outpatient clinic of a tertiary centre from January 2021 to June 2021 were eligible to participate. Demographic data, as well as medical/ surgical data including a history of a COVID-19 infection were collected. All patients had an antibody test for COVID-19. Patients with a positive antibody test were offered cardiovascular magnetic resonance imaging (CMR). Result(s): Altogether, 420 patients (44.8% female, mean age 36.4+/-11.6 years) were included in the study. Congenital heart defect (CHD) complexity according to the Bethesda classification was simple in 96 (22.9%), moderate in 186 (44.3%), complex in 117 (27.9%), and miscellaneous in 21 (5.0%) patients. A positive antibody test for COVID-19 was present in 28 (6.7%) patients (CHD complexity: Simple n=5, moderate n=14, severe n=7, miscellaneous n=2). Out of these 28 patients, 14 had no symptoms at all. Those with symptoms had mainly mild symptoms and were all managed in the outpatient setting. While 11 patients (39.3%) were not at all aware of their infection, 17 already knew that they had COVID-19. There was no significant difference between ACHD patients with a positive test vs those with a negative test regarding age, gender, New York Heart Association class, or complexity of CHD. Out of the 28 patients with a positive antibody test, 14 agreed to a CMR. A myocardial involvement, i.e. signs of active or healed myocarditis, was not present in any of these. Conclusion(s): In this single-centre study, 6.7% of ACHD patients attending the outpatient clinic had positive antibodies for COVID-19. Out of these, 50% were asymptomatic and 39.3% were not aware of their infection. A myocardial involvement was not found in any of the patients that underwent a CMR. These results indicate a large number of undetected cases of COVID-19 in the ACHD population and offer reassurance that in the vast majority of cases the infection has a mild course.
RESUMEN
Background: Adults with congenital heart disease (ACHD) are considered at increased risk for complications due to COVID-19, especially in those with cyanosis or heart failure. However, data regarding the rate of infection as well as regarding a myocardial involvement of a COVID-19 infection in ACHD patients are currently lacking. Purpose: To study the rate of COVID-19 infections in ACHD patients from a tertiary centre as well as the rate of myocardial involvement of a COVID-19 infection. Methods: All consecutive ACHD patients (over the age of 18 years) who attended the outpatient clinic of a tertiary centre from January 2021 to June 2021 were eligible to participate. Demographic data, as well as medical/surgical data including a history of a COVID-19 infection were collected. All patients had an antibody test for COVID-19. Patients with a positive antibody test were offered cardiovascular magnetic resonance imaging (CMR). Results: Altogether, 420 patients (44.8% female, mean age 36.4±11.6 years) were included in the study. Congenital heart defect (CHD) complexity according to the Bethesda classification was simple in 96 (22.9%), moderate in 186 (44.3%), complex in 117 (27.9%), and miscellaneous in 21 (5.0%) patients. A positive antibody test for COVID-19 was present in 28 (6.7%) patients (CHD complexity: simple n=5, moderate n=14, severe n=7, miscellaneous n=2). Out of these 28 patients, 14 had no symptoms at all. Those with symptoms had mainly mild symptoms and were all managed in the outpatient setting. While 11 patients (39.3%) were not at all aware of their infection, 17 already knew that they had COVID-19. There was no significant difference between ACHD patients with a positive test vs those with a negative test regarding age, gender, New York Heart Association class, or complexity of CHD. Out of the 28 patients with a positive antibody test, 14 agreed to a CMR. A myocardial involvement, i.e. signs of active or healed myocarditis, was not present in any of these. Conclusions: In this single-centre study, 6.7% of ACHD patients attending the outpatient clinic had positive antibodies for COVID-19. Out of these, 50% were asymptomatic and 39.3% were not aware of their infection. A myocardial involvement was not found in any of the patients that underwent a CMR. These results indicate a large number of undetected cases of COVID-19 in the ACHD population and offer reassurance that in the vast majority of cases the infection has a mild course. Funding Acknowledgement: Type of funding sources: Public Institution(s). Main funding source(s): Bayerisches Staatsministerium für Wissenschaft und Kunst
RESUMEN
Point-of-care antigen tests (PoC-AgTs) for the rapid detection of SARS-CoV-2 infection enable screening of additional populations with less effort, independent of laboratories and at a low cost. PoC-AgTs have therefore been included in national testing strategies with additional quality requirements to address limitations in specificity and sensitivity. Information given in the package inserts of the test providers should enable the user to evaluate the performance of a PoC-AgT in advance. The quality of this information has been independently assessed since the Corona Test Ordinance came into force in Germany in October 2020. The completeness of analytical and diagnostic performance specifications was assessed for all package inserts publicly available via the Paul Ehrlich Institute (PEI). It was ascertained whether the minimum criteria, recommendations, and extended criteria of the PEI were comprehensibly fulfilled. The number of tests removed from the list by March 2021 was determined. By the closing date of the survey (17.11.2020), the PEI had listed 165 PoC-AgTs that formally fulfilled the minimum criteria and were thus reimbursed. A total of 78 identical systems were identified. Almost all providers were found to have gaps in the information on the validation results of their tests, meaning that an evaluation of performance is only possible to a limited extent. Until March 2021, 25 non-identical PoC-AgTs have been removed from the list. Many PoC-AgTs could not be comprehensively evaluated based on the information provided by the provider. Users are therefore dependent on provider-independent sources of information. © 2021 Mustafa Özcürümez et al., published by De Gruyter, Berlin/Boston.