Thanks for the link
@ATHENS1964.
Always interesting when a company sells off a valve and I decided to look a little deeper. I have a few red flags about this new valve and will give my thoughts below.
A little digging finds additional details about the motivation for the sale:
“A steady decline in heart valve sales and pressure from investors have ultimately resulted in a new home for LivaNova’s product line.”
https://www.medtechdive.com/news/livanova-offloads-heart-valve-tech-to-gyrus-capital/591540/
Also, please see the publication below, published in 2020, which discusses concerns about the structural integrity of this sutureless valve, particularly in young patients:
"The use of newer generation bioprostheses, although attractive for their ease of implantation, can potentially carry higher long-term risk due to their shorter durability leading to reintervention to address valve deterioration. This is especially true in low-risk patients who are young and active. These patients are likely better served with the time-tested prostheses with long-established durability and freedom from structural deterioration. A mechanical valve in a young, otherwise healthy and compliant patient has an excellent long-term prognosis despite the risks of lifelong anticoagulation and bleeding or thrombosis"
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7092772/
Here is a randomized trial for this valve on elderly patients with average age of 75 and severe symptoms. I can't help but get a little laugh when I look at how they worded their Objective: "
We sought to demonstrate noninferiority of sutureless versus standard bioprostheses in severe symptomatic aortic stenosis."
Did someone slip the writer of the abstract truth serum? Yes, we know that in industry funded research that the goal is to demonstrate noninferiority or superiority, but in theory those conducting randomized trials are supposed to be seeking accurate data, not to have the goal to demonstrate noninferiority of the product sponsoring the research. Technically, in science when you have a hypothesis, you are supposed to try to disprove your hypothesis, not prove it. But, in reality, I just point this out for the humor of it and not counting the way they worded their study objective against this valve. I actually appreciate the honesty in the wording.
Also, this is only one year data on what appear to be high risk patients.
They looked at MACCE (major adverse cerebral and cardiovascular events) outcomes after one year, which were very similar, but they did find significantly more need for pacemakers in the Perceval group, at the rate of 308% higher rate. I would not gloss over this.
" ...but resulted in a higher rate of pacemaker implantation (11.1% vs 3.6% at 1 year). "
https://www.jtcvs.org/article/S0022-5223(20)33339-0/fulltext
Here are some comments and questions I have about this valve:
1) There was a lot of marketing generated excitement about this valve around 2016. Why have sales not matched the expectations? If this valve is truly so revolutionary, why did they feel the need to sell off this division to stop the bleeding? If you truly have a superior product, why not continue to invest in more studies in the hope of demonstrating the superiority of your product in the long run?
2) The well respected Eric Roselli of the Cleveland Clinic was one of the lead authors of the Perceval study. We have had dozens of members get their procedures done at Cleveland Clinic over the past few years and I don't recall anyone sharing that they have been offered the Perceval valve as an option. CC prides itself at consistently being ranked #1 in the nation in valve surgery and they go to great lengths to maintain this reputation. So, why is this exciting new valve not being offered to their patients? Hopefully, if someone has been offered such a valve at CC or any other clinic, they can share that with us, especially if they opted for this valve choice. Do let us know how it is going please.
3) While the one-year data is comparable in terms of MACCE outcomes, there are concerns about this valve's structural integrity beyond this, particularly with younger patients. I would define young as under 70.
4) There appears to be over a 3x greater risk of the need for pacemaker implantation during the first year with this valve.
5) Picking up from my commentary from #1 above, is the new owner of this valve targeting 3rd world clinics with aggressive marketing, despite the fact that there are serious durability issues with this valve and questions about its use for low risk patients under 70?
6) Perhaps this valve is a good option for high risk patients who do not qualify for TAVI. In fact, it is similar to TAVI in some ways. If a patient is 85 years old with comorbidities and high risk, yet is not eligible for TAVI, perhaps the lower cross clamp time would justify use of a sutureless valve for this patient. However, it does not appear that they have even made the case for these patients- the data seems to show "noninferiority" and not superiority. And then there is the 300%+ risk of the need for pacemaker. I don't see any data for lower risk patients under 70, so this would appear to be a significant roll of the dice.
Overall, before this valve is recommended for patients, given the concerns about long term structural integrity, perhaps more data needs to be seen. There appears to be a complete lack of data for younger low risk patients for this valve.
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