Dec 23 2022 This Week in Cardiology

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In This Week’s Podcast

For the week ending December 23, 2022, John Mandrola, MD comments on the following news and features stories.

The Year in Review

Normally, I take two weeks off during the holidays. This week, I thought I would try something new.

A recap of the year. I wrote a recap, but I am afraid fewer and fewer people read words anymore.

But, in case you have read my Top Ten of 2022, this episode will include some honorable mentions and other comments.

Before I start, I want to mention a two-part end-of-the year-recap from Drs. Bob Harrington and Michael Gibson. You should listen to it because these are real academics.

Live Meetings

The first thing to say about 2022 is how good it was to have in-person meetings again. My gosh, it was nice to shake hands and hug and speak to each other without a computer delay. I took many lessons from the pandemic, but one is that Zoom for education is horrific.

During the pandemic, my granddaughter, who lives next door, did something called non-traditional learning, which is as grand a euphemism as any in medicine. She learned nearly nothing, and so it goes with Zoom lectures. I will agree to no more virtual talks.

I even heard rumors that one big cardiac meeting is doing away with the virtual option next year. If true, I say, good.

That said, cardiology meeting organizers are going to have to do something to attract regular doctors. A pre-pandemic trend that was clearly worsened on return, is the sparse attendance of regular clinicians.

This year, what I saw in US meetings were three types of attendees: faculty types, youngsters who had presentations and industry people.

I hope organizers find a way to bring back regular clinicians who use the meetings to do CME. Of course, this is no small challenge, because conference fees, hotels, and travel are super-expensive, plus, employed docs, whose success turns on productivity, worry about days away from the office or labs. I really think meetings could be shortened. We need better content. Better speakers. More debates.

If the content was good enough, people would come. Otherwise, these meetings will turn into boondoggles for the academy.

Practice – Changing

To me, the most important trial of the year, by far, was REVIVED BCIS2. Kudos to the entire team.

Imagine for a second that you are in the cath lab with a 70-year-old woman with an EF of 27% and she has three vessel CAD, and each of the lesions are amenable to PCI, and before the cath, she had viability studies showing substantial areas of viable myocardium.

REVIVED-BCIS2 found that giving this woman medical therapy (simple pills) would be as good as PCI. Seriously, there was no difference in death or HHF or all-cause death, or MI, or QOL, or get this, even EF.

If revascularization of such a patient cannot improve outcomes over medicines, to me, this has to be the spark to help us start believing COURAGE and ISCHEMIA and oodles of other studies saying that PCI ought to be reserved mostly for acute plaque rupture and MI.

I really don’t know how Divaka Perera and Mark Petrie and other others pulled this off. But it’s a trial that ought to be reviewed in every center’s journal club.

Spin

Recall that spin is language or maneuvers that distract from a non-significant primary endpoint. For readers of the medical literature, it’s important to recognize this technique, often used by proponents of an intervention.

This year, I gave the spin award to the GUIDE-HF trial of CARDIOMEMS vs standard care in patients with HRrEF. CARDIOMEMS led management vs standard care resulted in a 12% reduction that did not reach significance. The P value was 0.16. There were no differences in CV death. Only HF visits.

But no matter, the authors, many of whom declared financial ties with the company, presented a pre-COVID analysis of approximately three quarters of the patients who completed followup before lockdowns. This was done in consultation with the FDA, and in this post-hoc, subgroup, the HF visits were reduced enough to eke by with a p-value of .05. They didn’t emphasize that the quarter of patients followed during the lockdowns, a time when a wireless device ought to have done well, showed no difference in outcomes.

FDA approved the $20,000 device and now we, like many other hospitals, are implanting it. And we wonder why there are health disparities and high costs of care.

Exemplary Reporting

Since I just told you about the year’s best example of spin, let me follow with year’s most honest reporting of non-significant results. It’s an important contrast. It’s also important to see how science should be done and reported.

There is much talk about bias within trials or in conclusions, but always remember, the greatest bias comes when trials are designed—especially if industry is involved. This isn’t nefarious, it’s just fact.

I’ve know Nassir Marrouche, now at Tulane University for almost a decade. He’s a generous and kind scientist who had the idea that areas of fibrosis in the left atrium would be a driver for AF, and an important target.

He spent years fine-tuning the ability to detect these areas of scar in the left atrium. He did preliminary studies showing their association w AF and AF ablation outcomes.

And instead of promoting this technique via single center studies and case reports, and eminence, he designed a proper trial, called DECAAF II trial where in patients with AF would be randomized to fibrosis targeted ablation or standard PVI.

They found no difference in the primary outcome of AF episodes. Patients in the fibrosis guided group had a higher rate of procedural complications.

Their conclusions were “Findings do not support the use of MRI-guided fibrosis ablation for the treatment of persistent AF.”

There was no spin, no pre-COVID analyses, no hedging. I loved this story. It enhanced my already high respect for Prof Marrouche.

My Surprise of the Year

I am almost convinced that screening healthy people to prevent death from one disease helps only the screeners not the screened. PSA, Mammography, colonoscopy, CAC, Vascular screening are all techniques which purport to show that detection of early disease, leads to treatment of that one disease and prevention of death from that one disease, and then extended survival.

But anyone who works in a hospital and has their eyes and mind open knows that there are thousands of diseases that can kill you.

Empirical studies have shown that survival benefits from screening for serious disease are minimal to none. That is why, this year, the results of DANCAVAS screening trial surprised me.

Axel Diederichsen is a soft-spoken cardiology professor in Odense Denmark. His idea was that you could invite people to a very efficient (approx. 40 minute) CV screening session after clinic hours and then act on data to reduce overall mortality.

This spartan program included a questionnaire, ankle-brachial index, CT scan of chest and abdomen, which only assessed for calcium in the coronaries or aorta, a rhythm strip during the CT scan and blood draw for lipids and glucose. You could not do this in the US, because the CT was not overread by radiologists. It simply looked for calcium or aneurysms. That is it.

After more than five years of follow-up, there was a 5% lower rate of death in the invited-to-screening group. The confidence intervals of this hazard ratio ranged from 0.90-1.00. The conclusion in the New England Journal of Medicine read that the screening program did not significantly reduce mortality, but the bulk of the confidence interval was below 1.00. For a survival benefit.

Note that only two-thirds of the invited group even had screening. These results were not in those screened. They were in the group invited. Prof Diederichsen said that they will eventually analyze the results of those who came to screening, the so-called on-treatment analysis–but the true scientific question is whether a population-based screening for CV disease would improve survival.

You may wonder why the invited to screen to group is the proper way to study the question. I mean, how can you benefit from screening if you don’t get screened. Well, the answer is that you study the invited to screen group because those who show up for screening are surely different types of people than those that don’t. And those factors—confounders—may be what makes then live longer, not the screening process.

Dogmas Felled

I like it when scientists put dogmas to the test. When you discharge patients with heart failure, there a blue million things to go over.

One of the issues is sodium restriction. Too often, I see patients beat down with the most draconian dietary restrictions. People’s attention is like a bank. You don’t want to use up all this attention on one thing—such as sodium restriction.

The question regarding advice for sodium restriction in patients with heart failure is a matter of degree.

The stronger the restriction, the more educational attention capital we use

The international SODIUM HF trial compared a modest sodium restriction of less than 1500 mg/day against standard care. Standard care included standard sodium-intake restrictions.

The pragmatic trial reported no significant differences in the primary outcome of cardiac-related hospitalizations or emergency-department visits or death.

Criticism of the trial centered on the fact that the control group only took in 2000 mg/day of sodium vs 1600 mg/day in the active arm. The average American diet usually entails more than 3000 mg/day. So, the thinking goes: if the SODIUM HF intervention was compared to an American diet, it would have been positive.

Maybe that is true.

What I take from this trial is that we don’t have to spend extra capital on severe restrictions. Give standard recommendations on sodium and move on to the many other important heart failure therapeutics.

More Beats Less in Heart Failure with Reduced Ejection Fraction

Many days when I open Twitter, or email, I see nudges from heart failure experts pushing for simultaneous imitation and rapid titration of guideline-directed medications for patients with heart failure.

The results of the STRONG-HF trial gave the speed movement a boost.

The trial enrolled about 1600 patients with acute heart failure in 14 countries. Patients were randomized to a high-intensity arm that included aggressive up-titration of heart failure medications during 4 visits (with cardiologists) in the 6 weeks after admission vs a standard care arm.

Patients in the high-intensity arm had a statistically significant 34% reduction in the primary endpoint of readmission for heart failure or death. Notably, both all-cause death and cardiovascular death were reduced by 16% and 26% respectively.

But there were criticisms of STRONG-HF. Some argued that the trial had a weak control arm, and it “basically shows that close follow-up and treatment with HF meds work and [it] can’t tell us much about what titration strategy is best.”

I felt strongly about STRONG-HF. The trial showed that if you are (very) serious about the intensity of follow-up and use of medications, outcomes are better.

Of course, implementing such a program will require a commitment from health systems. The question is whether these health systems have the resources or will to hire enough clinicians to see HF patients 4 x in 6 weeks. Wow, that is a lot.

A Surprise in Policy Studies

In June, JAMA-Cardiology published a super-interesting paper from the BI group in Boston – First author Andew Oseran and senior author Rishi Wadhera on how insurance coverage affected health care access, and cardiovascular risk factor management for working-age adults with low income.

In the US, we have issues with covering the cost of healthcare. Healthcare insurance most often stems from employment by a big company. If you are self-employed or work for a small company, you have to buy insurance privately, and it is super expensive.

If you are sufficiently poor, you may qualify for government funded insurance, called Medicaid—which isn’t great but does grant those with low- or no-income access to basic health care.

There are observational data showing an association with being under-insured or not insured and having worse outcomes.

We have a debate about how much Medicaid should be offered.

Some states expanded Medicaid; some states did not. This created the makings of a natural experiment.

The nifty study from BI correlated outcomes based on the exposure of Medicaid expansion or not. The main outcomes were health care access and monitoring and treatment of cardiovascular risk factors.

28 million working age adults. About a third were in non-expansion states and two-thirds were in expansion states. People in nonexpansion states had

• Lower rates of insurance

• Less likely to have a regular doctor

• Less likely to have recent exam

• More likely to have deferred care b/c of cost.

This all has to be bad, right? Having basic healthcare is important.

The outcome of this study was the treatment of CV risk factors. Arguably an important thing.

There were no significant differences in cardiovascular risk factor management between these groups.

In this study, working-age adults with low income in Medicaid nonexpansion states experienced higher uninsurance rates and worse access to care than did those in expansion states; however, cardiovascular risk factor management was similar.

I love this study because it highlights an important concept—one I’ve learned from an economist, Robin Hansen, at George Mason University.

This study is not an outlier. There have been three major trials that have all found that more health insurance leads to more healthcare but has no appreciable effect on outcomes.

Clearly…the evidence shows that having health insurance leads to more access to care. But on average this does not lead to better outcomes. How could this be. My theory is that those who are uninsured and very sick get things get cared for. I don’t know about other countries, but here, if you show up with a heart attack, stroke or major trauma, you get care, regardless of insurance.

What is missed when under- or non-insured is preventive care. Perhaps these sorts of studies aren’t detailed enough to show differences in outcomes. Perhaps. But I really wonder whether basic health outcomes don’t depend so much on what we in healthcare offer. Perhaps basic health outcomes, say, not dying early of heart disease or cancer or lung disease has more to do with societal factors. That is, if you live in a community where the norm is to smoke, or not exercise or not go on to learn a trade or get a college degree it is these factors that lead to higher rates of disease. Maybe it is not access to care. Of course, I am not arguing that people do not have access. I am merely suggesting that we consider the possibility that what we offer in non-urgent conditions or asymptomatic people is marginal. The public health implications is that policy and monies might be better spent on societal solutions rather than medical solutions. Building parks and biking trials instead of colonoscopy centers and cath labs. My bias is that this empirical evidence—with its limitations—suggest that we shine most when we care for people who are asking for our help.

And that is why my favorite thing to do in medicine is a pacemaker for complete heart block. It’s used to seem banal, compared to a complex ablation, but now I appreciate its purity.