Thread by @dr_benoy_n_shah

#EACTS2021

This 🧵is related to Thursday's symposium on Edwards' Inspiris Resilia aortic bioprosthetic valve

The hospital in which I work used this valve for ~2yrs before stopping, so I was intrigued to hear the experts

A thought-provoking session!
@rafasadaba @GilbertTangMD

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First talk from Prof Takkenberg, who needs no introduction to any of you. A very important talk in which she questioned the primacy of RCTs and spoke up on the importance of 'real world' registry data, often dismissed as poor quality

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I learnt a new acronym today - GOBSAT!
Good Old Boys Sat Around the Table!
i.e. expert consensus, LoE - C! Love it!

She emphasised that a lot of our evidence, esp in VHD, is GOBSAT!

@mirvatalasnag @mrjzacharias

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Correctly, she highlighted that 1 issue with RCTs is the very selective nature of the patients enrolled - often leading to much better outcomes in trials than we see subsequently in real life - TAVI & SAVR example here

This reduces external validity of the results

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Other problems highlighted with RCTs were under-representation of women and ethnic minorities - again reducing external validity of results

If data are mostly from Caucasian males in affluent countries...how relevant are the data on a global scale?

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Concluded by emphasising that RCTs and observational / real world data should be viewed in combination and as complimentary, not as RCTs are the untouchable gold standard that should never be questioned...

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Next talk from Dr Kocher giving an Austrian single-centre experience of the Inspiris Resilia valve

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Starts off with an explanation of the valve structure.

Based on the highly successful Perimount valve design, with new features to reduce leaflet calcification & for ring to 'expand' to facilitate future V-in-V TAVI when AVR degenerates

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This slide is a little over-hyped imho...the valves were explanted after just 8 months...we need a longer timeframe, but I understand the premise - these leaflets are hopefully less prone to calcification

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INDURE registry data upcoming...

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Maybe I'm just spoilt by excellent outcomes where I work, but I was worried by these data

30-day mortality 2.6% in a cohort with mean age just 60, and 94pts are <60yrs old? We didn't have STS scores that I saw, but this seemed really high to me

Is that unfair?

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Final talk in this symposium by Professor Bert Meuris from Leuven. Health economic data...hmmm...let's see!

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Starts by highlighting that implant rates for mechanical valves in ALL age ranges are falling, including the <60s...that was quite striking to see

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However, if you put tissue valves into younger patients, you're going to have problems (well, the patients will...)

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Again, the data (that Prof Meuris' team conducted) showing significantly less leaflet calcium on the Inspiris compared to Perimount valve after 8 months in an animal model...my thoughts on this later...

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Many registries and small studies conducted

The pitch was very much that these valves may be used in patients that would otherwise receive a mechanical valve - mAVR means more bleeding, tAVR means more re-do procedures

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Retrospective review of patients that had been allocated to mAVR or tAVR with Inspiris - latter group had shorter stays in ICU & overall in hospital

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This slide was...interesting

There was NO mention of the cost of the Inspiris Resilia valve itself and how that compares to a mechanical valve...see end of thread for why that matters...

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These slides were used to illustrate that anticoagulation comes at a price, soemtimes due to low INR needing admission for correction or bleeding complications causing admission and possibly major harm

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Conclusions here from Prof Meuris

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So, my thoughts? Well, this was a cleverly crafted session. The constant theme through the talks was to question the primacy of RCTs & showcase the utility of real world data

Now, as it happens, I *agree* that RCTs have major flaws, especially some done recently...

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Cherrypicking patients to maximise likelihood of a significant difference between two arms is not useful, if the outcomes achieved in an RCT - upon which FDA / CE approvals may be based - simply cannot be recreated in our daily practice

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However - where I disagreed is what we do about this. The answer is not to embrace retrospective observational studies even more but to improve RCTs! We *have* to demand better of our randomised studies. There's a reason randomised studies are considered best

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Randomisation evenly & randomy distributes all variables - known & unknown - that could influence outcomes

So, must do better to enrol women, to enrol ethnic minorities & to reduce exclusion criteria...of course, *obvious* reasons trial sponsors may not be keen

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In our hospital, we stopped using Inspiris Resilia due to cost. These were valve costs to us:

Mechanical AVR - £1100
Perimount Magna Ease - £1500
Inspiris Resilia - £3000
(Sapien 3 TAVI - £20,500 - just for info)

So, Inspiris was DOUBLE the cost of Perimount

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Our surgeons were not very happy. But, on this occasion, I had some sympathy with the managers too. The new valve is DOUBLE the cost of the old valve and there are ZERO data (by definition) *proving* that it lasts longer than the original Perimount Mgane Ease

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In theory, the valve should last longer & V-in-V TAVI should have better outcomes-but of course no-one knows for sure, as that hasn't happended yet

So, if you work in a wealthy nation without restrictions, I can understand you may opt to pay more for the new valve

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But, the Perimount Magna Ease is already a very good valve! Most patients get >10 years from it and a decent % get between 13-15 years

Are we saying we think Inspiris Resilia will last significantly longer than that?? I'm not so sure...

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I'm sure I'm coming across as too cynical. I don't mean to. I applaud Industry for spending R&D funds on improving bioprostheses & Edwards has been a leader in the field

But, it would be nice to have a well-conduced RCT of Inspiris vs mAVR in 50-60yr olds

End! 😀