COVID-19 vaccination in adults with congenital heart disease: Real-world data from an Italian tertiary centre

Flavia Fusco; Giancarlo Scognamiglio; Assunta Merola; Anna Selvaggia Roma; Carmine Nicastro; Micaela Spatarella; Maurizio D'Abbraccio; Gabriella Di Mauro; Umberto Atripaldi; Lidia Atripaldi; Anna Correra; Michela Palma; Rosaria Barracano; Nunzia Borrelli; Annalisa Capuano; Berardo Sarubbi

doi:10.1016/j.ijcchd.2021.100266

COVID-19 vaccination in adults with congenital heart disease: Real-world data from an Italian tertiary centre

Int J Cardiol Congenit Heart Dis. 2021 Dec:6:100266. doi: 10.1016/j.ijcchd.2021.100266. Epub 2021 Oct 28.

Authors

Flavia Fusco¹, Giancarlo Scognamiglio¹, Assunta Merola¹, Anna Selvaggia Roma¹, Carmine Nicastro², Micaela Spatarella³, Maurizio D'Abbraccio⁴, Gabriella Di Mauro⁵, Umberto Atripaldi², Lidia Atripaldi², Anna Correra¹, Michela Palma¹, Rosaria Barracano¹, Nunzia Borrelli¹, Annalisa Capuano⁵, Berardo Sarubbi⁵

Affiliations

¹ Adult Congenital Heart Disease Unit, AO dei Colli - Monaldi Hospital, Naples, Italy.
² Department for Laboratory Medicine, AO dei Colli - Monaldi Hospital, Naples, Italy.
³ Pharmacovigilance Unit, AO dei Colli - Cotugno Hospital, Naples, Italy.
⁴ Vaccination Unit for Vulnerable Patients, AORN dei Colli - Cotugno Hospital, Naples, Italy.
⁵ Section of Pharmacology "L. Donatelli", Department of Experimental Medicine, University of Campania "Luigi Vanvitelli", Naples, Italy.

Abstract

Background: real-world data on COVID-19 vaccine safety, immunogenicity and acceptance in adults with congenital heart disease (ACHD) are lacking.

Methods: ACHD patients who were offered COVID-19 vaccination from January to June 2021 were included. Data on adverse events, on patients' attitude towards vaccination and antispike IgG titre were retrospectively collected. A group of healthy individuals with similar age and sex undergoing vaccination was included for comparison.

Results: 208 patients followed in a single ACHD tertiary centre (33.3 [26-45] years, 54% male) received COVID-19 vaccine, 65% vaccinated at our institution: 199 (96%) received Pfizer-BioNTech BNT162b2 vaccine, 4 (2%) Moderna-1273 and 5 (2%) AstraZeneca-ChAdOx1. Median follow-up after vaccination was 79 [57-96] days. No major adverse event was reported and the incidence of minor events was not different between ACHD patients and the control group. One patient was diagnosed with acute pericarditis. There were two deaths unrelated to the vaccine during follow-up. Three (1.5%) vaccinated patients tested positive for COVID-19. Antispike IgG titre, available in 159 (76%) patients, was 1334 [600-3401] BAU/ml, not significantly different from the control group (p=0.2). One patient with Fontan failure was seronegative. Advanced physiological stage was associated with lower antibody response, independently from previous viral exposure (p<0.0001). Fourteen percent refused COVID-19 vaccination at our institution. However, 50% of vaccinated patients declared to have been influenced by the discussion with the ACHD cardiologist and 66% of those vaccinated in situ reported that undergoing COVID-19 vaccination at the ACHD centre made them feel safer.

Conclusion: COVID-19 vaccines appear safe in ACHD with satisfactory immunogenicity. However, the most vulnerable patients showed lower antibody response. ACHD team may play a key role in vaccine acceptance.

Keywords: ACHD; Adult congenital heart disease; Antibody response; COVID-19; IgG antispike; Vaccination.