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Vaccination against SARS-CoV-2 provides substantial benefits in people with heart failure but many of these high-risk patients are hesitant to get vaccinated, new research suggests.
Unvaccinated patients were three times more likely to die from COVID-related illness than those who were fully vaccinated (hazard ratio [HR], 0.36; 95% CI, 0.30 – 0.43) or vaccine-boosted (HR, 0.33; 95% CI, 0.23 – 0.48).
There was no significant mortality difference between patients who were partially vaccinated vs unvaccinated (HR, 0.87; 95% CI, 0.68 – 1.12).
Unvaccinated or partially vaccinated patients were also significantly more likely to be admitted to the hospital (incidence rate ratio [IRR], 0.68) and require ICU admission (IRR, 0.63), even after adjusting for relevant factors like age, sex, race/ethnicity, obesity, diabetes, and pulmonary disease.
“Despite conservative statistical approaches, the hazard ratios were striking,” lead author Anuradha Lala, MD, Icahn School of Medicine at Mount Sinai in New York City, told theheart.org | Medscape Cardiology.
Although the study was underpowered to detect differences between patients who were boosted vs fully vaccinated, COVID-19 vaccines seemed to benefit most those vaccine-boosted, followed by the fully vaccinated, partially vaccinated, and unvaccinated.
“These are observational data, so one can’t prove causality but it certainly underscores the profound protective effects of vaccination against COVID-19 amongst patients with heart failure,” she said.
Commenting on the study for theheart.org | Medscape Cardiology, Ileana L Piña, MD, MPH, Thomas Jefferson University, Philadelphia, Pennsylvania, said this is a single-center study of patients in the Epic record system but was conducted during an active period of the pandemic in New York.
“I think this should give comfort to the heart failure population to get vaccinated because there is definitely an impact on how you will do without excess mortality,” she said.
The results, published June 9 in the Journal of Cardiac Failure, were drawn from 7094 patients with a heart failure (HF) diagnosis who had visits with the Mount Sinai Health System between January 1, 2021, and January 24, 2022. They averaged age 73 years, and 48% were female.
Based on record review, 31% of patients were fully vaccinated with two doses and 14.8% had gone on to receive a booster, as per Centers for Disease Control and Prevention guidance at the time.
Another 9.1% of patients were partially vaccinated with one dose, whereas a full 45% remained unvaccinated by January 2022.
Of the 904 patients who died over a mean follow-up of 9 months, 73.4% were unvaccinated or only partially vaccinated.
Previous work has shown that patients with HF are at greater risk of complications if infected with COVID and face an almost twofold greater risk of dying than those without HF. The corollary of how protective COVID-19 vaccines are in HF, however, has been missing and was a key driver of initiating the study, Lala observed.
Early in the vaccine roll-out, professional societies like the Heart Failure Society of America issued statements offering assurance about vaccine safety, but fear remains.
“As a heart failure cardiologist, I’m seeing patients in the clinic all the time who are fearful of getting the vaccine,” Lala said. “And when I probe and ask why, many of them mention that, ‘I already have a history of heart failure and I heard reports of myocarditis and that the vaccine can affect my heart in a negative way. So I don’t want to take that risk.’ “
“It’s been difficult to convince some patients that the cardiovascular benefits of vaccination substantially outweigh the risk of complications because concrete evidence specific to the heart failure population was lacking,” she said.
What the retrospective study can’t answer is whether concerns about myocarditis may resonate more with patients with HF or other cardiovascular disease. Patients with chronic diseases have been generally more likely to get vaccinated than the general public.
On the other hand, misinformation abounds and studies have reported the risk of myocarditis is about 0.24% with a SARS-CoV-2 infection vs 0.002%, or roughly 100-fold less, with a COVID-19 vaccine, observed Lala.
“My personal opinion is that myocarditis, as a result of vaccination, has been sensationalized and not contextualized with the relative risk of having myocarditis and other complications due to COVID-19,” she said.
Piña said she’s encountered similar resistance and misconceptions. “They say I don’t want any viruses in my system, thinking that the vaccine has a live virus in it, which is something else we need to dispel — what the vaccine is made of,” she said.
To determine whether adverse events were associated with COVID, the investigators conducted a secondary analysis of 1767 patient encounters with a least one positive test for SARS-CoV-2.
Results show that SARS-CoV-2 positivity was associated with higher rates of hospitalization (IRR, 1.67), ICU admission (IRR, 2.01), and mortality (HR, 3.39; P value for all < .001).
Among patients with positive tests, vaccinated status was associated with lower rates of hospitalization (HR, 0.83; P = .02), ICU admission (IRR, 0.57; P = .009), and mortality (HR, 0.35; P = .045) compared with unvaccinated status.
“COVID-19 is still upon us, so we can’t become complacent,” Lala said. “I think we often put blame on the patient, ‘Oh, they refused vaccination.’ But I think we have to do a better job of understanding what are the barriers in their mind to getting vaccinated, what are the fears, what is the resistance, and then seek to fill those gaps with knowledge and data applicable to them.”
The authors note that the study did not capture seropositivity, hospitalization, or death in other hospital systems; did not distinguish based on whether patients had HF with preserved or reduced ejection fraction (HFpEF/HFrEF) or by stage of HF; and that data on specific treatments for HF or COVID-19 weren’t available.
“They didn’t make a distinction between HFrEF and HFpEF, but if you look at the population, they’re in the mean age range of the 70s, so it’s the population that you know when they have heart failure can get sicker,” Piña pointed out. “Just by age alone, it’s a vulnerable population, which makes this more valuable even.”
“And they had enough women. Most heart failure trials only have an average of 20% women and here they had 48% women, which tells me they probably have a lot of HFpEFs in here too,” she said. “So the message to the public is, please get vaccinated, your risks are much better for doing well.”
The study was internally supported. Lala has received personal fees from Zoll, outside the submitted work. Piña reported serving on an advisory board for ViFor Pharma.
J Card Fail. Published online June 9, 2022. Full text