Myopericarditis is a collective term referring to inflammatory disorders affecting the heart muscle (myocarditis) or surrounding lining tissue (pericarditis). Both have been linked to COVID-19 infection but also vaccination. There are many causes and patients often experience chest pain, breathlessness or collapse due to underlying heart rhythm disorders or reduced heart function. One of the main causes is a viral infection that cross-reacts with proteins in the heart, thereby triggering an immune response that can cause more harm than good. Several studies have now indicated that myocarditis occurs following COVID-19 infection. But furthermore, there are international reports of myocarditis happening in previously healthy young individuals shortly after COVID-19 vaccination too. Pericarditis can equally be caused by COVID-19 infection, although the risks after vaccination have not been characterised yet.
At present, we have very limited understanding of the risk of myopericarditis after COVID-19 infection or vaccination, and the actual scale of this problem within the UK.
A fine balance exists between the risks of COVID-19 infection itself versus the vaccine. Some of our prior work using national hospital admission data has informed the UK government's current strategy on COVID-19 vaccination with regards to myocarditis risk, but there is a clear unmet need to study the risks of myopericarditis after COVID-19 vaccination.
We seek to describe the overall scale and scope of myopericarditis linked with COVID-19 infection and vaccination to guide patients and their clinicians as well as policymakers to ultimately reduce morbidity and mortality linked with these inflammatory heart conditions.
The COVID-19 pandemic has had a profound effect on driving inflammatory conditions both due to COVID-19 infection but also COVID-19 vaccination. Myopericarditis refers to inflammation affecting the heart muscle and/or surrounding tissue and is mainly driven by maladaptive immune responses. This process can be triggered by COVID-19 infection but also by COVID-19 vaccination, as recognised from June 2021. Given the rapid roll-out of the vaccination program, there is pressing unmet need for further research in this area.
We aim to describe the real-world clinical burden of myopericarditis in two COVID-19 cohorts; (i) within 14-days, 30-days & 12 weeks after COVID-19 infection and (ii) within 14-days, 30-days & 12 weeks after COVID-19 vaccination. We will present the incidence rates at these time points and patient demographics including age, sex, ethnicity, geographical region, cardiovascular comorbidity and history of myopericarditis. We will include linked data from CHESS to capture all COVID-19 hospitalisations and HES APC to evaluate the natural history of ensuing myopericarditis. We will present mortality rates across these groups.
We will describe the percentage of patients exposed to COVID-19 infection and vaccination that subsequently develop myopericarditis, relative to two main comparison cohorts. Firstly, we will study patients who had myopericarditis prior to the pandemic (2015-2020), presenting the demographics and point prevalence of myopericarditis per annum pre-COVID. Given that the COVID-19 pandemic has substantially changed disease epidemiology due to changes in healthcare provision, social distancing and healthcare seeking behaviours, this will help contextualise our findings and determine whether changes in incidence rates or outcomes are confounded by other aspects of the pandemic, Secondly, to further contextualise our main findings, we will also include a population of patients with influenza prior to the pandemic to understand whether associations in our COVID-19 cohorts were caused by acute respiratory infection or specifically by COVID-19 infection/vaccination.
Primary objective:
The primary objective is to determine the incidence rates of myopericarditis at 14 days, 30-days and 12 weeks following COVID-19 infection and COVID-19 vaccination, with reference to the incidence of myopericarditis prior to the pandemic (2015-2020). We will request linked CHESS data to ensure we identify and include all patients with COVID-19 infection.
Secondary objective:
The secondary objective is to describe the patient demographics for these groups affected by myopericarditis, to identify any changes linked to the pandemic. We will present demographic features (including age, sex, ethnicity, geographical region, comorbidity including diabetes, hypertension, prior myocardial infarction, heart failure, immunocompromised state or cerebrovascular event) and history of myopericarditis in the COVID-19 infection and COVID-19 vaccination cohorts, as well as the pre-pandemic (2015-2020) myopericarditis and influenza cohorts to contextualise our main findings. We will request linkage to the HES APC dataset, as this includes the complete set of hospital episode information (admission and discharge dates, specialists seen under and procedures undertaken) for each linked patient with a hospitalisation record. This will help inform which patient groups should be most closely monitored for future healthcare needs
Tertiary objective:
The tertiary objective is to explore the natural history and clinical outcomes across these groups to determine any potential features that may have utility in guiding future patient management. Clinical outcomes of interest will include all-cause mortality, major adverse cardiac event (MACE), major arrhythmia composite endpoint (aborted sudden cardiac death, sustained ventricular tachycardia, second or third-degree heart block), and major heart failure composite endpoint (unplanned hospitalisation for heart failure, need for heart transplantation or left ventricular assist device implantation) again in the COVID-19 infection and COVID-19 vaccination cohorts, as well as the pre-pandemic myopericarditis and influenza cohorts. We will request linkage to ONS dataset to ascertain mortality status and cause of death, in addition to the linked HES and CHESS data.
Sanjay Prasad - Chief Investigator - Imperial College London
Amrit Lota - Corresponding Applicant - Royal Brompton Hospital
Alexander Smith - Collaborator - Imperial College London
Devendra Meena - Collaborator - Imperial College London
Ioanna Tzoulaki - Collaborator - Imperial College London
Jennifer Quint - Collaborator - Imperial College London
Mark Cunningham - Collaborator - Imperial College London
HES Admitted Patient Care;ONS Death Registration Data;CCG Pseudonyms