Surgical procedure or Transcather mitral valve replacement for low risk patient

[cp172]

Hi Guys & Gals,

I am facing mitral valve replacement and my surgeon is debating replacing my mitral valve by cracking my chest or inserting the valve by transcather. I underwent a CT today for him to study. I am low risk so I did not know that I could be a candidate for transcather. I can not find where FDA has approved for low risk. Any thoughts on which valves/procedure works the best? I think the surgical valve would be a biological valve and the transcather a Edwards bioprosthetic (bovin tissue).

Thanks for any comments,

Mickey

 

[vitdoc]

Not sure if non open heart mitral valve replacement is FDA approved in the US for anyone. Most are being used in studies. I may be wrong on this.
The track record for these is relatively short. Are you a candidate for a mitral clip? Do you have primarily insufficiency or stenosis? How old are you?
If you are relatively young say <60 you will likely need another procedure with a tissue valve. Questions to ask the surgeon or cardiologist.

 

[sylviayasgur]

Hi Mickey,
You might want to have a look (chat) with ShezaGirlie :
Mitral Valve Replacement in Austin, Texas!!! Your comments/experience please!.
She just went through this decision in august.
Hope this helps and please keep us posted!
All the best,
sylvia

 

[rich01]

https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/TMVRhttps://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=273

 

[vitdoc]

I think there is a little confusion with the terminology. From the initial question it sounded like implantation of a mitral valve via a catheter vs surgical placement. The term Transcatheter mitral valve repair has been used for the mitral clip for some patients with mitral regurgitation. Replacing the valve in the mitral position via a catheter is relatively new and still in the US not FDA approved for everyone. It is akin to TAVR. The mitral clip procedure has been around for over 10 years and has gained some traction. I actually had mitral clips placed four years ago for suddenly decompensated mitral regurgitation. Worked like a charm for me. I would have been facing a fourth open heart. First two for AS the third aortic aneurysm. No one was eager to open me up for the mitral so I had the clips.
So far so good.

 

[pellicle]

I am facing mitral valve replacement and my surgeon is debating replacing my mitral valve by cracking my chest or inserting the valve by transcather.

my thoughts are that your wording suggests your predisposition.
"cacking my chest" is suggestive of destruction of something like eggs

"inserting" is suggestive that its somehow a tender process.

Myself having worked on a few engines and such like I can say that being able to see things clearly helps a lot and often leads to less issues. I've had my "chest cracked" 3 times now. I'm pretty healthy all things considered.

something I wrote here just the other day:
https://www.valvereplacement.org/th...ce-your-valve-replacement.887695/#post-900031
PS: if one only thinks in "diagrammatic artist impression cartoon representations" of these things the reality of how dirty breaking off a crusty old valve is, may not be as clean as you want.

https://www.ahajournals.org/doi/10.1161/JAHA.116.004399
https://www.tctmd.com/news/tavr-debris-captured-sentinel-embolic-protection-differs-valve-type
https://www.tctmd.com/news/embolic-debris-captured-filters-three-quarters-tavr-patients
So if you have ever done any construction work in your house you'll know its often easier to take that lump of wood outside before cutting on the circular saw rather than clean up the mess in your vascular system later.

Just my impressions.

 

[rich01]

PS: if one only thinks in "diagrammatic artist impression cartoon representations" of these things the reality of how dirty breaking off a crusty old valve is, may not be as clean as you want.

https://www.ahajournals.org/doi/10.1161/JAHA.116.004399
https://www.tctmd.com/news/tavr-debris-captured-sentinel-embolic-protection-differs-valve-type
https://www.tctmd.com/news/embolic-debris-captured-filters-three-quarters-tavr-patients
So if you have ever done any construction work in your house you'll know its often easier to take that lump of wood outside before cutting on the circular saw rather than clean up the mess in your vascular system later.

Just my impressions.

Strokes from debris are rare and the filter is expensive.
https://www.medpagetoday.com/meetingcoverage/tvt/80462

 

[dornole]

Like vitdoc I would ask what is the reason for replacement to make sure all options are considered. When I had mitral stenosis I had a valvuloplasty (balloon through catheter) and that worked very well to open the valve. I believe that procedure has a long track record (Mine was 17 years ago) but it has limited utility, to treat stenosis. It is expected to worsen regurgitation by a degree which did happen to me but was a good trade off. You can see in the other thread mentioned above more discussion. My cardiologist participated in the first transcatherer mitral valve replacement in US for one of the trials, I think the Tendyne one. I don’t know the current status but there is at least some info there. Last I heard the transcatheter mitral was still considered higher risk than OHS so restricted to people who likely would not survive ohs. All good questions to go through with your medical team.

 

[pellicle]

Strokes from debris are rare

Oh, well in that case no problems.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5803543/#!po=0.574713
Data from the PARTNER 1A study showed a risk of neurologic events with SAVR of 2.4% at 30 days and 4.3% at one year, with corresponding rates for TAVR of 5.5% and 8.3%, respectively.
...
Early stroke is mainly due to debris embolization during the procedure, whereas later events are associated with patient specific factors. Despite the fact that the rate of clinical stroke has been constantly decreasing compared to initial TAVR experience, modern neuro-imaging with MRI suggests that new ischemic lesions post-TAVR are almost universal.

 

[rich01]

Oh, well in that case no problems.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5803543/#!po=0.574713
Data from the PARTNER 1A study showed a risk of neurologic events with SAVR of 2.4% at 30 days and 4.3% at one year, with corresponding rates for TAVR of 5.5% and 8.3%, respectively.
...
Early stroke is mainly due to debris embolization during the procedure, whereas later events are associated with patient specific factors. Despite the fact that the rate of clinical stroke has been constantly decreasing compared to initial TAVR experience, modern neuro-imaging with MRI suggests that new ischemic lesions post-TAVR are almost universal.

I researched this before having TAVR last year. My interventional cardiologist assured me there was no need for the filter.

Partner 1A was more than 10 years ago and used 1st generation valves with only seriously ill patients participating in the trial. There was a problem with the early valves and procedure and has been corrected.

From the article I linked.

He emphasized considering the "true number" of strokes that would occur without protection, and then only the disabling ones (or ones that patients would notice): only 0.9% in the control arm of SENTINEL, and 0.6% in PARTNER 3's TAVR arm.

And this from a February 24, 2020 article:

Early real-world use of the Sentinel cerebral embolic protection device did not reduce procedural strokes after transcatheter aortic valve replacement (TAVR) for severe symptomatic aortic stenosis, a study found.

https://www.medpagetoday.com/cardiology/pci/85052

 

[cp172]

Here is a little more info:

I am 65 years old and heart is in good shape.

I had a mitral valve repair by Da Vinci 12 years ago because of a bad chordea. A repair is not possible this time.

I have been told my mitral valve is not closing properly causing blood to be regurgitated ..flowing back into lungs. Comparing several echos shows a deteriorating trend.

A board of cardiologist and surgeons will review my case and CT October 30th to recommend options.

My notes from the meeting with the cardiothoarcic surgeon and interventional cardoligist listed two options 1) Redo Surgery and 2) TMVR (replacing mitral valve). This was listed out on a grease board by the surgeon and he wrote I was "low risk".

I have an appointment with my electrophyisiologist Wednesday and plan to ask him some questions since he referred me to the CA and IC. I see him because I started having AF a few years ago. He has had to cardio convert me a couple of times and preformed an ablation on me in July of this year.

Thanks for your responses.

Mickey

 

[cp172]

Not sure if non open heart mitral valve replacement is FDA approved in the US for anyone. Most are being used in studies. I may be wrong on this.
The track record for these is relatively short. Are you a candidate for a mitral clip? Do you have primarily insufficiency or stenosis? How old are you?
If you are relatively young say <60 you will likely need another procedure with a tissue valve. Questions to ask the surgeon or cardiologist.

HI Vitdoc,

The doctors said that I could possibly have two more valve replacements in my lifetime and they want to keep that in mind when making a recommendation. There was not a mention of mitral clip and I think the issue is worsening stenosis. I am gathering a list of questions to ask the doctors. Thanks for your response.

Mickey

 

[cp172]

Hi Mickey,
You might want to have a look (chat) with ShezaGirlie :
Mitral Valve Replacement in Austin, Texas!!! Your comments/experience please!.
She just went through this decision in august.
Hope this helps and please keep us posted!
All the best,
sylvia

Hi Sylvia,

Thanks for the link. I will certainly check it out.

Mickey

 

[cp172]

I think there is a little confusion with the terminology. From the initial question it sounded like implantation of a mitral valve via a catheter vs surgical placement. The term Transcatheter mitral valve repair has been used for the mitral clip for some patients with mitral regurgitation. Replacing the valve in the mitral position via a catheter is relatively new and still in the US not FDA approved for everyone. It is akin to TAVR. The mitral clip procedure has been around for over 10 years and has gained some traction. I actually had mitral clips placed four years ago for suddenly decompensated mitral regurgitation. Worked like a charm for me. I would have been facing a fourth open heart. First two for AS the third aortic aneurysm. No one was eager to open me up for the mitral so I had the clips.
So far so good.

Vitdoc,

I am glad your clip has been working like a charm. Maybe the cardiologist meant to say clip but he never used the word. I just can not get my mind around being a Low Risk and doing Transcatheter. I could easily just be confused.

Mickey

 

[pellicle]

I researched this before having TAVR last year. My interventional cardiologist assured me there was no need for the filter.

so, all good then

 

[cp172]

my thoughts are that your wording suggests your predisposition.
"cacking my chest" is suggestive of destruction of something like eggs

"inserting" is suggestive that its somehow a tender process.

Myself having worked on a few engines and such like I can say that being able to see things clearly helps a lot and often leads to less issues. I've had my "chest cracked" 3 times now. I'm pretty healthy all things considered.

something I wrote here just the other day:
https://www.valvereplacement.org/th...ce-your-valve-replacement.887695/#post-900031
PS: if one only thinks in "diagrammatic artist impression cartoon representations" of these things the reality of how dirty breaking off a crusty old valve is, may not be as clean as you want.

https://www.ahajournals.org/doi/10.1161/JAHA.116.004399
https://www.tctmd.com/news/tavr-debris-captured-sentinel-embolic-protection-differs-valve-type
https://www.tctmd.com/news/embolic-debris-captured-filters-three-quarters-tavr-patients
So if you have ever done any construction work in your house you'll know its often easier to take that lump of wood outside before cutting on the circular saw rather than clean up the mess in your vascular system later.

Just my impressions.

Hi Pellicle,

Great analogy with car engines. I told the doctors at the preliminary meeting I wanted to have the procedure that had the highest success rate instead of the easiest procedure. I want that crusty valve spit shined!

Mickey

 

[cp172]

Like vitdoc I would ask what is the reason for replacement to make sure all options are considered. When I had mitral stenosis I had a valvuloplasty (balloon through catheter) and that worked very well to open the valve. I believe that procedure has a long track record (Mine was 17 years ago) but it has limited utility, to treat stenosis. It is expected to worsen regurgitation by a degree which did happen to me but was a good trade off. You can see in the other thread mentioned above more discussion. My cardiologist participated in the first transcatherer mitral valve replacement in US for one of the trials, I think the Tendyne one. I don’t know the current status but there is at least some info there. Last I heard the transcatheter mitral was still considered higher risk than OHS so restricted to people who likely would not survive ohs. All good questions to go through with your medical team.

Dornole,

I will make sure to mention the procedure you mentioned.

Thanks,

Mickey

 

[pellicle]

Hi
glad I hit the nail on the head on that one ;-)

...I told the doctors at the preliminary meeting I wanted to have the procedure that had the highest success rate instead of the easiest procedure. I want that crusty valve spit shined!

I just had a small surgery on my foot for removing arthritis, and as part of my exploration on that I began researching outcomes for the same surgery done "conventional" vs "keyhole"

The recurrence and worsening of the problem was significantly increased with keyhole (nearly 5 times worse, but still under 15%) and that led me to wonder about the role of "swarf" from the rotary burr grinder finding its way into the joint VS the whack of a chisel (and big lumps can be picked out). I asked the second surgeon I consulted about this and he said "I don't do keyhole for that reason".

Anyone who's used a dremel knows how much small bits of rubbish get all over the place. I try to imagine cleaning the wound of bone fragments inside the confines of the toe (which btw also gets inflated with gas IIUK) and simply can't.

But out of sight out of mine, and all that matters is appearance and not having an unsightly scar on you it seems.

 

[vitdoc]

Placing mitral clips for mitral insufficiency is not easy. The procedure is becoming somewhat more available but there are a limited number of physicians who are expert at it and have a large experience. I had my procedure done in 2016 by a physician in Los Angeles who at that time had the most experience in the US and maybe in the world. So there may be parts of the country especially outside large metropolitan areas that don't have the capability to perform this procedure. It is only for certain types of mitral insufficiency and certainly not for stenosis. I was worried that I might get stenosis from the procedure.
Fortunately I believe this is relatively uncommon. I have nearly no gradient across the mitral valve. Placing mitral valves via catheter appears to be somewhat more complicated than in the aortic position. There is less tissue to adhere to than at the aortic position. I saw one valve design have a tether to the apex of the heart to help support the valve. Looked a little Rube Goldbergish. Time will tell if these valves will last and whether there may be issues with sudden valve displacement. Need enough of these in the wild for enough time to find out.

 

[cp172]

Placing mitral clips for mitral insufficiency is not easy. The procedure is becoming somewhat more available but there are a limited number of physicians who are expert at it and have a large experience. I had my procedure done in 2016 by a physician in Los Angeles who at that time had the most experience in the US and maybe in the world. So there may be parts of the country especially outside large metropolitan areas that don't have the capability to perform this procedure. It is only for certain types of mitral insufficiency and certainly not for stenosis. I was worried that I might get stenosis from the procedure.
Fortunately I believe this is relatively uncommon. I have nearly no gradient across the mitral valve. Placing mitral valves via catheter appears to be somewhat more complicated than in the aortic position. There is less tissue to adhere to than at the aortic position. I saw one valve design have a tether to the apex of the heart to help support the valve. Looked a little Rube Goldbergish. Time will tell if these valves will last and whether there may be issues with sudden valve displacement. Need enough of these in the wild for enough time to find out.

Hi Vitdoc,

Good info to know. I plan to call my Patient Navigator tomorrow to see if she can get some answers for me while I wait on the surgical board to make a recommendation.

Thanks,

Mickey