Name: Feb 20 2026 This Week in Cardiology
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You're listening to this Week in Cardiology from theheart.org, medscape Cardiology.

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Any views expressed are the presenter's own and do not necessarily reflect the views of WebMD or Medscape.

Hi everyone, this is John Mandrola from the heart.org Medscape Cardiology.

And this is this Week in Cardiology for February 20, 2026.

This week, longer term data in the Evolute Low risk TAVI trial, a provocative meta analysis, DNR targeted hypothermia, good news and HFPEF evidence, GLP1 agents as AFIB drugs and the evaluation of patients with chest pain.

There was big news in the TAVI versus SAVR in low risk patients.

This week JAK published six year outcomes of the Evolute Low Risk trial and there were surprises.

Now recall that the Evolute Low Risk was first published in the New England Journal of Medicine in 2019.

This had 1,468 patients with severe AS and they were randomized to the self expanding Medtronic TAVI valve versus Surgical avr.

This study had a non inferiority design with a primary endpoint of death or disabling stroke at two years and it was analyzed with Bayesian methods.

The trial found a greater than 99% probability that TAVI was non inferior to surgical AVR or SAVR.

Now many trials have shown similar outcomes for TAVI versus SAVR at 2 years low surgical risk.

Patients though want to know about longer duration outcomes including the valve reliability and the intervention or reintervention rate.

Now before I say anything about the results, I have to say that both the balloon expandable and self expanding trialists have been excellent about reporting longer term.

I mean other than the Partner 3's mysterious change of primary endpoint, the entire evidence landscape of TAVI versus surgical AVR has been pretty exemplary.

All right, the main results of this six year trial the primary composite endpoint continued to be death or disabling stroke.

However, change is that the trial is no longer analyzed by Bayesian methods and they no longer use non inferiority.

Using Kalpenmaier estimates, the composite of all cause mortality or disabling stroke was 23.3% for TAVR versus 20.4% for surgery.

That difference was 2.8 percentage points higher for TAVI.

This fairly large absolute risk increase did not come close however to reaching statistical significance.

The P value calculates at 0.43 at this 6 year report Many of the patients had 7 year outcomes and at 7 years with a vital status sweep, the mortality rates were more divergent, 27.7% for TAVI, 23.9% for SAVR.

Cardiovascular mortality was essentially identical between the groups, 11.1 versus 11.0%.

A major point of emphasis and a new finding came when they looked at reintervention rates, which were similar at 5 years but divergent in years 6 or 7, namely cumulative reintervention rates were 5.5% versus 3.3%.

At 6 years that P value was 0.07 and it rose to 9.8% reintervention tavi 6.0 reintervention surgery at 7 years.

Now that P value is 0.02 in favor of surgery.

Now, I know that you could easily gloss over the medical jargon reintervention, but I would not.

Because reintervention for TAVR can be quite serious, especially if it is surgical, as it was in two thirds of the reoperations in this trial because observational data have shown death rates as high as 13% when you have to operate or cut out a TAVI valve and replace it with a surgical valve.

Now, the reintervention death rates were only 3.3% in this trial, but

these were low risk patients and these were highly skilled operators.

In other words, I guess I'm just saying that reintervention in TAVI is a really serious outcome.

Now, the causes of reintervention are important.

The rates of intervention for aortic stenosis of the bioprosthetic valve was similar in the two groups, but

more patients in the TAVI arm had reintervention for aortic insufficiency than those in the SAVR arm.

And that could be important because AS tends to be slow and AI might be more acute.

Now, seemingly perplexed by the higher reintervention rates, the authors did an exploratory analysis looking at the use of something called post deployment balloon dilatation using a balloon larger than the valve waist.

This they termed off guidance post dilatation.

And this exploratory analysis showed us just barely significantly higher rate of reintervention in patients who had off guidance dilatation.

And so the proponents could say, aha, just don't do off guidance dilatation and all will be good.

But I guess I would caution against this sort of thinking because a the association could be noise, wasn't that significant, and

b doctors aren't doing dilatation willy nilly right.

They do it because they see a potential problem like non ideal valve expansion or maybe A paravalvular leak.

And so there could be reverse causality or confounding.

It might not be the off guidance post dilatation, it might be the reason that they were doing off guidance post dilatation.

Now there's also a suggestion that older evolute valve types may be causal in these reintervention rates and newer iterations may be better.

But of course we don't have six year datas on these newer valves.

So my comments on this whole thing from a neutral perspective.

The first thing to say is that we've got to take the view of a patient, right?

Even if a tavi is 1 or 2 or 3% worse at 10 years, I think rational people, some rational people might favor the substantially less invasive procedure.

I mean it takes months to recover from open heart surgery, so there is that.

But many 65 or 70 year old patients with AS would care what happens when they get close to 80 years old.

A substantial difference in mortality would be something that many people would consider really important in their decision.

Now the other thing to say or to start with is that tavrs may be similar to PFA in that not all tavrs are the same, right?

The higher reinnervation rates seen with evolute in this trial have not been seen with balloon expandable valves.

But not only is the reintervention worrisome, the death signal also looks worrisome to me.

Now, I don't really think you should ignore a nearly 3% higher rate of death than the Tavar arm.

David Cohn pointed out online to me that a p value of 0.4 suggests it is not surprising given a null hypothesis of no difference.

But I would counter that by saying that a typical analysis of Kaplan Meier curves requires something called proportional hazards over time.

And this is not the case in these trials.

As the Kaplan Meier curves cross, there's early TAVI benefit and it changes to a later hazard.

And this means that there are non proportional hazards.

Now I know this sounds like gibberish, right?

Because the same journal, Jack, has published a review article discussing the problems and analytical solutions for non proportional hazards.

The second issue I have with the higher death rates in the TAVR arm is that the original Evolute trial used a non inferiority design with a non inferiority margin of 6%, which seems kind of high to me, but

nonetheless 6% starting with the three year analysis and I'll link to all these papers, the authors changed to a superiority testing strategy.

I could not find anywhere where that was pre specified.

Now at 7 years the authors write in discussion section that quote there are no significant differences were observed between the treatment arms for all cause mortality.

Now the difference in higher death rate is 3.7%.

The 95% confidence interval goes from minus 2.4% to 9.9%.

The P value is still not anywhere close to significant but the upper bound is 9.9% worse.

That's well larger than the 6% non inferiority margin.

Not only that, but something is changing over time in these mortality curves.

If you combine reports of death from the four year evolute paper to this paper, here's what you get.

The TAVR mortality goes from 9% to 27.7%.

The SAVR mortality goes from 12.1 to 23.9% and so SAVR mortality is only increased by 11.8%.

I wonder, had the authors stayed with their Bayesian design, what would the probability of TAVR having a higher death rate at six or seven years?

I suspect it would be pretty pretty high.

Now you think I'm being too harsh on tavr?

Well, what about the recently published BMJ HAART meta analysis first author Marin Cortes et al.

This was updated five year outcomes of TAVR versus SAVR in low to intermediate risk patients.

In HAART they meta analyzed six trials in about 7,400 patients and they found that the relative risk for all cause mortality was 1.12 and the credible intervals went from 1.02 to 1.22 with no heterogeneity.

Now it's a 99.3% posterior probability that SAVR was superior to TAVR for the endpoint of mortality at 5 years.

For stroke the median relative risk was 1.13.

The credible interval went from 0.93 to 1.39 with very little heterogeneity and that resulted in an 88.0 posterior probability that SAVR outperformed TAVR for stroke outcomes.

Now proponents of TAVR may argue that a 2025 meta analysis first author Rohin Reddy and I'll link to that in Jak found five year results better for Tavr.

Yet that meta analysis weighted trials with shorter results, specifically the Dedicate and evolute four year trials.