Like the phantom heart in Edgar Allan Poe’s short story, “The Tell-Tale Heart”, myths about COVID-19 vaccines and the risks for cardiovascular disease keep on beating.
The latest mythical bogeyman comes in the form of an abstract presented at the American Heart Association's annual meeting, claiming that COVID-19 mRNA vaccines increase the risk of a heart condition called Acute Coronary Syndrome. But a review of the data shows that this study is a tale that even Poe would find horrifying.
Credit: Victorian Era
Just The "Facts"
The study by Dr. Steven Gundry reports that a Protein Unstable Lesion Signature (PULS) test revealed an increased risk for Acute Coronary Syndrome in patients inoculated with mRNA vaccines against COVID-19. The PULS test was given to 566 patients, 3-5 months before vaccination, and again at 2-10 weeks following the second vaccine dose.
The results claim to show inflammation of the vascular endothelium, a layer of cells that make up the inner walls of blood vessels. Dr. Gundry also reported that his study found "T-cell infiltration of cardiac muscle". The study concludes that there is an increased risk for cardiovascular events, including heart failure, following COVID-19 vaccination.
The problem with the study is that it simply does not have the data to support the conclusions.
The PULS test at the core of this research is described in the abstract as "a clinically validated measurement of multiple protein biomarkers” that predict the risk of developing Acute Coronary Syndrome in the next 5 years. The reality is that the clinical accuracy of PULS is not validated by any published research using patients. A review of the product website finds 9 references that are cited to support its use – none of which investigate the ability of the PULS test to predict Acute Coronary Syndrome risk in patients.
Some of the biomarkers measured by PULS are used to assess cardiovascular risk by other clinical tests. But these measurements are just one part of a larger screen, which includes additional material such as age, sex, family history of cardiovascular disease, and other pre-existing medical conditions. Without the extra patient information, the validity of the test is compromised.
According to the PULS test website, the assay measures the levels of 9 proteins found in patients' blood to quantify their risk for Acute Coronary Syndrome. Despite the diversity of markers available for measurement, the abstract only presents data on 3 of the 9. Surprisingly, none of the selected markers of risk show any significant changes.
Finally, the statement at the end of the study claiming to have found T-cell infiltration of cardiac muscle comes with no evidence. T-cells are part of the immune system and are critical for providing the lasting immunity of vaccination. But high levels of T-cells within cardiac muscle is not a normal consequence of vaccination and would be concerning. The study provides no information on how cardiac T-cells were measured, or what the results were, suggesting that no investigation of cardiac T-cells was done.
Even though the study by Dr. Gundry reported no significant changes in markers to indicate a heightened risk for cardiovascular disease, some may point to “trends” in the data as a sign of future problems. The reality is that changes in inflammation are expected following vaccination, and many of these markers have already been investigated.
A study by Bergamaschi and colleagues investigated the immune response to the Pfizer/BioNtech BNT162b2 COVID-19 mRNA vaccine and found increased levels of inflammatory proteins circulating in the blood. These increases fell well below levels required to pose a risk to the cardiovascular system, and were noted to be expected changes that “promote[the] innate and adaptive immune response”. In other words: these changes are exactly what is expected following successful vaccination.
A Concerning Twist
Soon after publication, the American Heart Association received concerns about the Gundry study. After reviewing the abstract an “Expression of Concern” was published in the journal Circulation. Among the issues raised by the review were the lack of data in the abstract regarding T-cell infiltration of the heart; a lack of statistical analysis for significance provided; and the reliance on anecdotal data to draw conclusions.
In “The Tell-Tale Heart”, Poe’s protagonist ultimately reveals his secret and the story ends. Despite unmasking the fatal flaws of a study claiming to reveal a dangerous link between COVID-19 mRNA vaccines and cardiovascular disease, it is unlikely that this will be the end of the story for COVID-19 vaccineo opponents.
And that is something that is truly frightening.