Transcatheter or Surgical Replacement for Failed Bioprosthetic Aortic Valves; New study published May 22, 2024

[Chuck C]

I believe this is the first study published comparing the outcomes for TAVR vs SAVR, for procedure #2 tissue valve patients. Getting TAVR on #2 is often caled Valve in Valve Transcatheter, because the TAVR valve goes inside the old bioproshetic valve.

The findings are striking:

"ViV-TAVR was associated with higher rates of late mortality and heart failure hospitalization."

Not slightly higher, but much higher:

"no difference in mortality was observed up to 2 years (hazard ratio, 1.03; 95% CI, 0.59-1.78), but after 2 years, ViV-TAVR was associated with higher mortality (hazard ratio, 2.97; 95% CI, 1.18-7.47) as well as with a higher incidence of heart failure hospitalization (hazard ratio, 3.81; 95% CI, 1.57-9.22)."

That is correct. 2.97 hazard ratio for valve in valve TAVR vs SAVR after year 2 for all cause mortality. That represents a 2.97x greater rate of mortality. Incidence of heart failure hospitalization was also striking at hazard ratio of 3.81 for TAVR= 3.81x the risk as compared to SAVR.

I have the link to the study below and am also attaching a PDF which has more details and discussion about the study.

"Although the most recent international guidelines recommend ViV-TAVR for patients with failed bioprosthesis who are symptomatic or at high or prohibitive surgical risk,13,14 the rapid increase in the use of ViV-TAVR (10-fold over a period of 5 years) suggests that indication creep to other populations without an adequate evidence base may be occurring."

Many on our forum have come to the boards facing procedure #2 in their 40s, 50s and 60s, dissappointed that they were not eligible for TAVR (aka TAVI) on procedure #2, a hope which they were givin at the time of procedure #1. This new study suggests that, unless you are a patient at high risk for OHS, these individuals might be better off with SAVR. As always, more studies are needed.

TAVR will continue to advance and likely improvements will be made, but for procedure #2 it does not appear that the data is currently there yet to suggest that this is the best way to go for most patients. As suggested by the commentary from this study, it does appear that the rapid expansion of valve in valve TAVR got ahead of the evidence.

Transcatheter or Surgical Replacement for Failed Bioprosthetic Aortic Valves​

https://jamanetwork.com/journals/jamacardiology/article-abstract/2819144#:~:text=Findings In this cohort study,with a higher incidence of

 

[pellicle]

Well, that's comprehensive

Thanks

 

[pellicle]

creep

its not a creep, its an outright sprint. If there is any creep its the creeps who are marketing this and encouraging this.

I'm waiting for the first need to get that stent out of you and put in a standard prosthesis in an elder person who "wasn't a candidate" but pushed for it (and is now weakened permanently) because the bit of origami junk designed to help the very old and frail get a few more years before they pass.

At 50? I'd rather just take SAVR

 

[newarrior]

Thank you..It looks like TAVR will be for surgery #3 and #2 will be another SAVR

 

[treichert0312]

I had every intention of TAVR for procedure#2 but the bio valve failure was not a stenotic /calcifying type of failure. Sounds like I can be glad I did not get what I wanted.

 

[pellicle]

Sounds like I can be glad I did not get what I wanted.

I know that feeling. Back in 2011 I thought the On-X sounded like an interesting choice. I wrote a letter to my surgeon asking about it but saying that I leave the choice in his hands because he'll clearly be more familiar with it than me.

I'm pretty glad I didn't get the On-X for a few reasons.

 

[skeptic49]

The study notes that comparative studies done elsewhere based on an older average age cohort did not show a similar result. VIVTAVR still seems to be the therapy of choice for older people with failing aortic prosthetic valves

 

[Quarry1]

The study notes that comparative studies done elsewhere based on an older average age cohort did not show a similar result. VIVTAVR still seems to be the therapy of choice for older people with failing aortic prosthetic valves

Having been through this 6 months ago and not feeling that great even after 6 months , tired and light headed, I am wondering how successful this will be. EF after VIV-Tavr was only 25 with slight improvement to 35 a couple of months later. Seeing Cardio for tests on June 9.

 

[skeptic49]

Having been through this 6 months ago and not feeling that great even after 6 months , tired and light headed, I am wondering how successful this will be. EF after VIV-Tavr was only 25 with slight improvement to 35 a couple of months later. Seeing Cardio for tests on June 9.

Sorry to read of your unsatisfactory outcome. I am wondering about your specific situation, e.g., your age at initial AVR, prosthesis size, etc.

 

[pellicle]

Hey mate

Having been through this 6 months ago and not feeling that great even after 6 months , tired and light headed, I am wondering how successful this will be

time will tell ... I would think that at >80 it was pretty much the best choice for you. The article pertains to people under 60 in its scope.

Here's wishing you a good outcome!

 

[Quarry1]

Sorry to read of your unsatisfactory outcome. I am wondering about your specific situation, e.g., your age at initial AVR, prosthesis size, etc.

The initial AVR was done when I was 73. The valve was a St Jude Trifecta GT model TFGT-25A. I was and still am in good physical shape with no other health problems , very active with BMI of 25. The Trifecta deteriorated quickly, my guess is about 6 months. My concern is what is the condition of the heart now. I will know soon after the echo

 

[skeptic49]

The initial AVR was done when I was 73. The valve was a St Jude Trifecta GT model TFGT-25A. I was and still am in good physical shape with no other health problems , very active with BMI of 25. The Trifecta deteriorated quickly, my guess is about 6 months. My concern is what is the condition of the heart now. I will know soon after the echo

Thanks for the info. Do you think that your poor outcome with Viv-tavr could be related to the relatively small size of your Trifecta?

 

[Quarry1]

Thanks for the info. Do you think that your poor outcome with Viv-tavr could be related to the relatively small size of your Trifecta?

I have no idea if that had anything to do with it. I have heard that there is a class action against the valve manufacturer claiming that some of the valves were defective

 

[skeptic49]

I have no idea if that had anything to do with it. I have heard that there is a class action against the valve manufacturer claiming that some of the valves were defective

All of the Trifecta valves were recalled due to the rate of early failure. Mine is mine years since implant with some change in gradients. I have to follow-up with another echo soon. I have a 29 mm implant so if I get tavr hopefully the outcome will be satisfactory.

 

[Croooser]

Abbot has a letter on this if you search on: St Jude Trifecta GT model TFGT-25A. Sorry, can't seem to post a direct link.

 

[Quarry1]

All of the Trifecta valves were recalled due to the rate of early failure. Mine is mine years since implant with some change in gradients. I have to follow-up with another echo soon. I have a 29 mm implant so if I get tavr hopefully the outcome will be satisfactory.

My TAVR was a non event compared to my previous OHS which left me in the hospital for a month due to sepsis.