Evusheld and heart

[Moggn]

I’m now eligible for Evusheld (in Australia), being recently finished Rituxamib. My wife & I have been very cautious and are Covid-free so far, but thinking with so many Covid cases circulating now, it’s probably prudent to have the Evusheld

however, my careful daughter found a vague reference in FDA notes, to possible increase in heart issues after Evusheld. I’ve had 3 x atrial fibrillation episodes from previous CLL related triggers - FCR, pneumonia & Venetoclax start-up, all recovered ok by DCR. So with that apparent susceptibility I’m now a little unsure about going ahead with E.

Has anyone out there seen anything more substantive about heart side effects?

Ps - my neutrophils have just clicked up a bit and all bloods are charting into “normal range”

[Moggn]

Addendum to post - We are fully vaxxed & boosted.

[SofiaDeo]

I am not aware of anywhere the manufacturer has released data regarding the incidence & severity numbers/percentages. They do caution cardiac patients. And if your heart muscle or nerves are "irritable" such that metabolic changes (pneumonia, killing CLL cells, etc) are inducing arrhythmia, you are probably on the "more likely" than "less likely" end of the spectrum. Did you have any perception of palpitations or other cardiac events after vaccination?

[Moggn in reply to SofiaDeo]

I didn't actually notice the 3 times when I was in AF!! Clearly not very in tune to my body. And, no, had no discernible heart fluctuation after the vac's, (only a 1/2 day or so tired/headaching after one of them otherwise, just a bit of arm soreness )

[SofiaDeo in reply to Moggn]

Do you have an iPhone or Apple Watch, or other device where you could do a simple ECG at home? This might be a way to relieve any anxiety or concerns surrounding further treatments or diseases, let alone Evusheld.

[Moggn in reply to SofiaDeo]

Thanks, that’s a good idea.

[Maximilliana]

I noticed that reference in the patient notes and asked about it since I had an event of cardiac artery spasm last year. I was told by my specialist at Mayo and my cardiologist to not get Evusheld. I have had 4 shots of Moderna and get IVig monthly. It seems to be protecting me, since my grandkids and daughter, who I live with, all had Covid and I'm fine so far.

[Moggn in reply to Maximilliana]

Thank you. I’ll be checking in with my cardiologist about it.

[waer88]

I got afib from a cancer med and now see a cardiologist. My hematologist recommended evusheld and got it without a problem. With Covid all around, I’ve been fine. That said any med can have known or unknown side effects.

[Moggn in reply to waer88]

Thank you, that’s encouraging.

[SeymourB]

Moggn -

Since you have a history of afib, the best thing is to have your cardiologist and/or hematologist review the FDA EUA Fact Sheet for Healthcare Providers:

fda.gov/media/154701/download

It says on Page 1:

"• Cardiovascular Events: A higher proportion of subjects who received EVUSHELD versus placebo reported myocardial infarction and cardiac failure serious adverse events. All of the subjects with events had cardiac risk factors and/or a prior history of cardiovascular disease, and there was no clear temporal pattern. A causal relationship between EVUSHELD and these events has not been established. Consider the risks and benefits prior to initiating EVUSHELD in individuals at high risk for cardiovascular events, and advise individuals to seek immediate medical attention if they experience any signs or symptoms suggestive of a cardiovascular event."

Pages 10 and 11 elaborate a little more:

"Cardiac Serious Adverse Events

Through the additional data cut-off in PROVENT, a higher proportion of subjects who received EVUSHELD versus placebo in PROVENT reported myocardial infarction SAEs, one of which resulted in death, and cardiac failure SAEs (see Table 4 below). All subjects who experienced cardiac SAEs had cardiac risk factors and/or a prior history of cardiovascular disease at baseline. There was no clear temporal pattern, with events reported from several hours after EVUSHELD receipt through the end of the follow-up period."

Table 4 Cardiac SAEs Regardless of Causality in PROVENT with Onset Prior to Day 183

"EVUSHELD N= 3,461 Placebo N= 1,736

[first set of numbers below is for Evusheld, 2nd set is Placebo]

Subjects with any cardiac SAE* 22 (0.6%) 3 (0.2%)

SAEs related to coronary artery disease or myocardial ischemia† 10 (0.3%) 2 (0.1%)

Myocardial infarctions‡ 8 (0.2%) 1 (0.1%)

SAEs related to cardiac failure§ 6 (0.2%) 1 (0.1%)

SAEs related to an arrhythmia¶ 4 (0.1%) 1 (0.1%)

Other (cardiomegaly, cardiomyopathy, and cardio-respiratory arrest) 3 (0.1%) 0

* One EVUSHELD recipient and one placebo recipient had two cardiac SAEs each.

† Includes the preferred terms angina pectoris, coronary artery disease, arteriosclerosis, troponin increased, acute myocardial infarction, and myocardial infarction.

‡ Includes the preferred terms acute myocardial infarction, myocardial infarction, and troponin increased (with a discharge diagnosis of myocardial infarction).

§ Includes the preferred terms cardiac failure congestive, acute left ventricular failure, cardiac failure, and cardiac failure acute.

¶ Includes the preferred terms atrial fibrillation, arrhythmia, paroxysmal atrioventricular block, and heart rate irregular."

Page 11 reviews another study, STORM CHASER:

"Cardiac Serious Adverse Events

In STORM CHASER (N= 1,121) no cardiac SAEs were reported (median follow-up approximately 6 months). Compared to PROVENT, the subjects in STORM CHASER were younger (median age 48 versus 57 years) and had fewer baseline cardiac risk factors (24% versus 36% with hypertension, 11% versus 14% with diabetes, and 3% versus 8% with cardiovascular disease in STORM CHASER versus PROVENT, respectively)."

Working backwards from that 8% with cardiovascular disease in PROVENT, where N=3,461, we get approximately 277 people in PROVENT with actual cardiovascular disease. Since 4 PROVENT Evusheld patients had arrythmias, that works out to about 1.4% of the cardiovascular disease patients had arrythmias.

What we're seeing in the U.S. is that even if you don't get Evusheld, timely access to Paxlovid really helps, if you don't have serious drug conflicts that cannot be avoided by holding meds for 5 days.

BTW, I did have Evusheld before infection, and Paxlovid afterwards, and I think they both really kept me out of the hospital since I made very few antibodies after 4 shots and have hypogammaglobulinemia despite being watch and wait, and my BMI is 34. But I've also never had arrythmias.

Best of luck,

=seymour=

[Moggn in reply to SeymourB]

Thank you very much . That is way more comprehensive than what I had found. As you suggest, I’ll ask the cardiologist to review it.Again, many thanks.