Name: 2026年2月20日 心臟學本週報！ (Feb 20 2026 This Week in Cardiology)
Uploaded: 2026-02-24T13:44:31.000Z
Duration: 25 min 10 s

You're listening to this Week in Cardiology from theheart.org, medscape Cardiology.

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This podcast is intended for healthcare professionals only.

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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.

這項研究採用非劣性設計，主要終點為兩年內的死亡或致殘性中風，並使用貝氏方法進行分析。

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

試驗發現，TAVI 的非劣於外科主動脈瓣置換術 (SAVR) 的機率超過 99%。

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

現在許多試驗都顯示，對於低手術風險的患者，TAVI 與 SAVR 在兩年的結果相似。

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

然而，病患想知道長期的結果，包括瓣膜的可靠性以及介入或再介入率。

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.

在我說明結果之前，我必須說，無論是球擴式還是自擴式試驗的受試者，在報告長期結果方面都做得非常出色。

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.

除了 Partner 3 神祕地更改主要終點之外，TAVI 與外科主動脈瓣置換術的整個證據景觀都堪稱典範。

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

好的，這項為期六年的試驗主要結果，其主要複合終點仍然是死亡或致殘性中風。

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

然而，改變的是，試驗不再使用貝氏方法分析，也不再使用非劣性。

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

使用 Kaplen-Meier 估計值，TAVR 的全因死亡率或致殘性中風的複合終點為 23.3%，而手術為 20.4%。

That difference was 2.8 percentage points higher for TAVI.

TAVI 的絕對風險增加了 2.8 個百分點。

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

不過，這個相當大的絕對風險增加，離統計學上的顯著性還差得遠。

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.

在這份為期六年的報告中，P 值計算為 0.43。許多病患有七年的結果，在七年時進行生命狀態掃描，死亡率差異更大，TAVI 為 27.7%，SAVR 為 23.9%。

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

兩組的心血管死亡率幾乎相同，為 11.1% 對 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%.

一個重要的重點和新發現是當他們觀察再介入率時，五年時相似，但在第六或第七年時出現差異，累積再介入率為 5.5% 對 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.

在第六年時 P 值為 0.07，第七年時 TAVI 的再介入率上升到 9.8%，手術為 6.0%。

Now that P value is 0.02 in favor of surgery.

現在這個 P 值是 0.02，對手術有利。

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

好了，我知道你可能會輕易忽略「再介入」這個醫學術語，但我不會。

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.

因為 TAVR 的再介入可能非常嚴重，尤其是手術性的，就像這次試驗中三分之二的再手術一樣，因為觀察性數據顯示，當你必須進行手術取出 TAVI 瓣膜並換成手術瓣膜時，死亡率高達 13%。

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

現在，在這個試驗中，再介入的死亡率只有 3.3%，但是

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

這些都是低風險的病人，而且操作者技術都非常純熟。

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

換句話說，我想說的是，TAVI 的再介入是一個非常嚴重的結果。

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

兩組的生物瓣膜主動脈狹窄再介入率差不多，但是

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

TAVI 組因為主動脈閉鎖不全而需要再介入的病人，比 SAVR 組多。

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

這點可能很重要，因為主動脈狹窄通常進展緩慢，而主動脈閉鎖不全可能比較急性。

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.

現在，作者們對於較高的再介入率似乎感到困惑，他們進行了一項探索性分析，研究使用一種稱為「置入後氣球擴張」的方法，使用比瓣膜腰部還大的氣球。

This they termed off guidance post dilatation.

他們稱之為「非指引後擴張」。

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

這項探索性分析顯示，接受非指引擴張的病患，再介入率僅僅勉強達到統計上的顯著差異。

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

所以支持者可以說，看吧，只要不做非指引後擴張，一切都會好起來的。

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

但我猜我會對這種想法提出警告，因為關聯性可能是雜訊，並不那麼顯著，而且

b doctors aren't doing dilatation willy nilly right.

b 醫生並不是隨便做擴張的，對吧？

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

他們這麼做是因為看到了潛在問題，像是瓣膜擴張不理想或瓣周滲漏。

And so there could be reverse causality or confounding.

所以可能存在反向因果關係或混淆。

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

這可能不是非指引後擴張本身的問題，而是他們之所以要做非指引後擴張的原因。

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

現在也有人建議，較舊的 Evolut 瓣膜類型可能導致這些再介入率，而較新的版本可能更好。

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

但當然，我們還沒有這些新瓣膜的六年數據。

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

所以從中立的角度來看，我對整件事的評論是這樣。

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

首先要說的是，我們必須從病患的角度來看，對吧？

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.

就算十年後 TAVI 的結果差了 1%、2% 或 3%，我覺得理智的人，有些理智的人可能會比較喜歡侵入性少很多的做法。

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

畢竟開心手術要好幾個月才能恢復，這也是一個考量。

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

但很多 65 或 70 歲的 AS 病人，會關心到 80 歲時會發生什麼事。

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

死亡率的顯著差異，是很多人在做決定時會認為非常重要的考量。

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?

接下來要說的，或者要從這裡開始談的是，TAVR 可能跟 PFA 類似，不是所有的 TAVR 都一樣，對吧？

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

在這個試驗中，Evolut 瓣膜看到的較高再介入率，在球擴式瓣膜上並沒有出現。

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

但不僅是再介入讓人擔心，死亡率的訊號，在我看來也讓人擔心。

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

現在，我真的覺得你不應該忽略，比 TAVR 組高了將近 3% 的死亡率。

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.

線上跟我說，p 值是 0.4，這表示在沒有差異的虛無假說下，這並不令人意外。

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

但我會反駁說，Kaplan Meier 曲線的典型分析需要所謂的「風險比例性」。

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.

隨著 Kaplan Meier 曲線交叉，早期 TAVI 有好處，但後期風險卻會改變。

And this means that there are non proportional hazards.

Now I know this sounds like gibberish, right?

我知道這聽起來像胡說八道，對吧？

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

因為同一本期刊，Jack，發表了一篇評論文章，討論非比例風險的問題和分析解決方案。

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

我對 TAVR 組死亡率較高有第二個疑慮，那就是原始的 Evolute 試驗採用了非劣勢設計，非劣勢的範圍是 6%，這對我來說好像有點高，但是

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

儘管如此，從三年分析開始的 6% 範圍，我會把這些論文都連結放上去，作者們改用了優勢測試策略。

I could not find anywhere where that was pre specified.

我找不到任何地方說這是有預先指定的。

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.

現在到了七年，作者們在討論區寫道：「在所有原因的死亡率方面，治療組之間沒有觀察到顯著差異。」

Now the difference in higher death rate is 3.7%.

現在死亡率較高的差異是 3.7%。

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

95% 的信賴區間從負 2.4% 到 9.9%。

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

P 值仍然遠遠不夠顯著，但上限是差了 9.9%。

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

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

不僅如此，這些死亡曲線的數據隨著時間也在改變。

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

如果你把 Evolute 四年論文的死亡報告和這篇論文結合起來，你會得到這樣的結果。

The TAVR mortality goes from 9% to 27.7%.

TAVR 的死亡率從 9% 變成了 27.7%。

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

SAVR 的死亡率從 12.1% 變成了 23.9%，所以 SAVR 的死亡率只增加了 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?

我很好奇，如果作者們堅持使用貝氏設計，TAVR 在六到七年時死亡率較高的機率會是多少？

I suspect it would be pretty pretty high.

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

現在你覺得我對 TAVR 太嚴苛了嗎？

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

不過，首先我們來看看最近發表在 BMJ 的 HAART 的主要作者 Marin Cortes 等人。

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

這篇是針對低至中風險病患，TAVR 與 SAVR 的五年追蹤結果更新。

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.

在 HAART 研究中，他們統合了六項試驗，約 7,400 名病患，發現全因死亡率的相對風險是 1.12，可信區間從 1.02 到 1.22，沒有異質性。

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

現在有 99.3% 的後驗機率顯示，SAVR 在五年的死亡率終點上優於 TAVR。

For stroke the median relative risk was 1.13.

至於中風，中位相對風險是 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.

可信區間從 0.93 到 1.39，異質性非常小，這使得 SAVR 在中風結果上優於 TAVR 的後驗機率為 88.0%。

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.

現在 TAVR 的支持者可能會爭辯說，2025 年發表、主要作者 Rohin Reddy 的研究（我會把連結放在 Jak 中）發現 TAVR 的五年結果更好。

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

然而，該統合分析加權了結果較短的試驗，特別是 Dedicate 和 evolute 的四年試驗。

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2026年2月20日心臟學本週報！ (Feb 20 2026 This Week in Cardiology)

significant

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improve

2026年2月20日 心臟學本週報！ (Feb 20 2026 This Week in Cardiology)

significant

evidence

term

improve

2026年2月20日心臟學本週報！ (Feb 20 2026 This Week in Cardiology)