Name: Mar 27 2026 This Week in Cardiology
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Hi everyone, this is John Mandrola from theheart.org Medscape Cardiology,

and this is This Week in Cardiology for March 27, 2026.

This week: early aortic valve replacement and aortic stenosis, left atrial appendage occlusion in JAMA Cardiology, and

First up, let's talk about early aortic valve replacement.

New England Journal of Medicine published "Long-Term Follow-Up of the South Korean Recovery Trial of Early Aortic Valve Replacement for Conservative Care in Patients with Severe Aortic Stenosis." Now, the first publication of Recovery was in 2020,

Now, right there you're squinting, right, because most patients with aortic stenosis are near 80 years old.

But that's one of the many interesting things about this trial.

The mean age of patients was approximately 64 years.

The primary endpoint was operative mortality and CV death.

A primary endpoint event occurred in 2 of 73 patients, that's 3% in the early surgery group, and

in 17 of 72, 24% in the conservative care group.

For a hazard ratio, get this: 0.10, 95% conference intervals to 0.02 to 0.43, and p-value very significant.

Death from any cause occurred in 11 patients in the early surgery group, and

in 23 patients, 32%, in the conservative care group.

That hazard ratio is 0.42 and also highly significant.

This is very similar to the report in 2020 where it was 1 versus 11 primary endpoints for a hazard ratio of 0.09.

The interesting thing about this long-term follow-up is that 85% of the conservative arm crossed over and got AVR.

Only 11 of 72, or 15% of patients in the conservative arm, did not get surgery, which is shocking when I tell you the entry criteria.

Patients had to have very, very severe stenosis, an aortic valve area less than 0.75, a peak velocity greater than 4.5.

But the enrolled population were even worse.

The mean aortic valve area was 0.63, and the mean peak velocity was 5.1 meters per second.

I think this plays into why there's a 90% reduction in the primary endpoint.

These were relatively young people with few comorbidities, hence only two primary outcome events in 12 years in the early AVR group.

The severity of this "asymptomatic" aortic stenosis in quotes is also in question because 10 patients died before getting their valve replaced,

and 20% of those who crossed over, 1 in 5, had urgent aortic valve replacement.

That's kind of strange to go from asymptomatic to urgent AVR.

Another curious thing about this trial is the tiny number of events, 2 versus 17.

I calculated a fragility index, and it was only 3.

Three events would have changed it to non-significant, despite a hazard ratio of 0.10.

Now look, I don't disbelieve the results.

What I do question is, were these patients really asymptomatic?

This trial assessed symptoms by history alone, and everyone knows that aortic stenosis is slowly progressing,

and it gives time for people to adjust their activity.

So in the end, what I take from this paper is that if you have someone like these patients, a literal pinhole, I'd be darn sure they don't have symptoms.

And if they truly did not have symptoms, say they passed the treadmill, then I would follow them very closely.

Based on the small number of patients, two-thirds of whom had bicuspid valves, and

the extreme severity of the AS in these cases, along with their low comorbidity, I would not use this study as a reason to do early aortic valve interventions in a more common aortic stenosis patient who is elderly, more complex,

and has lesser degrees of aortic stenosis.

And I certainly wouldn't use this data to translate it to doing early TAVR in patients in their mid-60s, that young of an age.

All right, next topic is major bleeding with an Amulet and Watchman trial in JAMA Cardiology.

This was a secondary analysis of the Amulet IDE trial conducted from 2016 to 2019.

Now, rather than reporting on the primary device comparison between Amulet and Watchman 2.5, the authors report on major bleeding events.

The original Amulet IDE trial was a head-to-head comparison of the two different left atrial appendage closures devices.

The five-year results of the original Amulet versus Watchman 2.5 device were published in JAC in 2024.

Stroke and systemic embolism were similar at 7.4 versus 7.1%, as was major bleeding at 20.1 versus 20.0, basically the same.

This paper, the one in JAMA Cardiology, combined all 1,800 patients in both arms to assess predictors and outcomes of major bleeding.

The authors felt justified in doing this because the hazard ratio on the device arms was 1.0, so it was no different.

Briefly, these were 76-year-old patients with a mean CHADS-VASc score of 4.8.

The first was that major bleeding occurred in roughly 1 in 5 patients, approximately 18%, which seems like a lot.

Second finding, the timing pattern of major bleeding was very distinct.

In the first six months after the procedure, the annualized major bleeding rate was 20.5% per year.

After six months through year three, it was 3.9% per year.

I want to insert a note here that patients cannot exclude their peri-procedural time.

Though proponents like to talk about less bleeding in the later part of a study, the patients are part of both parts.

Third finding, most of the bleeds were GI, 57%.

Fourth, predictors of the bleeds will not surprise you.

Older age, female sex, diabetes, previous bleeding, kidney disease.

Notably, the device type, the antithrombotic regimen at discharge, and

device-related imaging findings did not, did not predict bleeding.

This suggests to the authors that bleeding risk lives in the patient more so than in the procedure.

perhaps most notable finding of this entire study is that nearly half, 47%, of the major bleeds occurred in patients on no antithrombotic therapy.

Sixth finding, in a comparison between patients who had a major bleed versus those who did not, patients who had major bleeding had significantly higher rates of everything bad: stroke, systemic embolism, cardiovascular death, 32.5% versus 18%.

And this was driven by higher strokes, so patients with major bleeding have more than double the number of strokes.

All-cause mortality was also higher in patients with major bleeding.

And major bleeding was fatal, BARC score of 5 in 25 patients or 1.4%.

And the authors concluded that major bleeding was common in this high-risk population, largely related to the underlying patient factors.

Early major bleeding was highest in the six months after appendage occlusion.

Most events were GI bleeding and occurred even in patients on minimal or no antithrombotic therapy.

Major bleeding after appendage closure was strongly associated with all bad outcomes, including stroke and mortality.

First, you have a relatively low annualized stroke rate of about 1.5 to 3% per year, but

nearly a 6% annualized rate of major bleeding.

Patients who had major bleeding clearly did worse in all aspects, including thrombotic events like stroke and CV death and all-cause death.

What this tells me is that we should definitely have a trial in older, sicker patients who have a high bleeding risk of left atrial appendage closure versus no antithrombotic.

Now, every time I discuss this at meetings, people worry about, "You wouldn't do anything for the patient?

But this study I'm discussing, from some of the best centers in the world, finds a super, super high rate of major bleeding in the first six months, annualized at 20% per year.

So therefore, the patient randomized to the nothing arm starts far ahead in the probability game of stroke and bleeding.

In such a trial of appendage closure versus no antithrombotic, the left atrial appendage occlusion arm has to overcome a very high major bleeding risk in the first six months.

And since no study that I know of finds that appendage closure reduces ischemic stroke, and