PROACT Xa Clinical Trial: The Journey to a Mechanical Valve Replacement WITHOUT Warfarin
Vložit
- čas přidán 26. 07. 2024
- www.Heart-Valve-Surgery.com - GREAT NEWS! The PROACT Xa Clinical Trial has begun enrolling patients to evaluate the safety-and-efficacy of the On-X mechanical valve replacement WITHOUT the use of warfarin, a blood thinner also known as Coumadin. In this special interview with Dr. Marc Gerdisch, you will learn how and why this clinical trial may provide patients several advantages for treating and managing heart valve disease using a mechanical valve replacement. You will also learn the science and the innovations specific to the On-X mechanical heart valve replacement, a unique device made from pyrolytic carbon, that led to this ground-breaking research study. In addition, you will also learn how the the PROACT Xa clinical trial may lead to decreased risks of stroke and bleeding for patients while providing a more convenient lifestyle without the need to monitor INR levels using labs or remote test services. Lastly, you will learn how patients can enroll in the PROACT Xa clinical trial. To learn more, call (317) 682-0089 or click www.heart-valve-surgery.com/s....
I got my mechanical mitral valve for my 25th birthday last week. Still trying to learn as much as possible but I finally feel like I’m getting a hang of it. It’s been slow going to get my INR up to the range I need it, but it’s a small price to pay for my life. I’m hopeful that the research will continue to evolve throughout my life and that I won’t need to be on blood thinners my whole life.
Great to hear Erica! Thanks for sharing your story!
i also have a mitralic ONx valve. Mitralc Valves MUST be on Warfarin! This study is only for Aortic valves. Mitral valves will always be on Warfarin.
@@SalvatoreEscoti the hope is the science and technology for these mech aortic valves can be adapted for development of mech mitral valves
@@SalvatoreEscoti That is not true, my surgeon told me they are already working on new replacements for Warfarin.
@@FesteringRatSub Mine told me a similar answer. He said it was all money driven. Eventually, within the next 5 years we may be able to take thinners that don’t require vitamin k restriction. I miss my big salads.
Great Video! I am liver transplant recipient (1989) and am now suffer from CKD and now I am looking at a pulmonary valve replacement so this information is really amazing. I have many worries about being opened up again, more drugs and the chance of the kidney's and liver being affected.
I am very FORTUNATE to have had Dr. Gerdisch as my surgeon 45 days ago! I have read through the info on the clinical trial and I am excited (like many others) that there is a good opportunity for an alternative to Warfarin. Love the video! Love my valve! Love what these Doctors and their Teams do! Thank you!
Great to hear Aaron!!! Wooo-Whoo!!!!
Thanks God for this video.i'm very fortunate to have this kind video.hope this procedure come soon in India as well.i have congential bicuspid aortic valve with moderate AR doctors has said to me that there is surgery required in next couple of years so I'm little bit disappointed about it and till then I watched almost all the video related to heart surgery...2 days ago I go to recheckup and ask to my cardiac physician may I go through Ross procedure when the surgery required??? ans is no he tell me u r very young 24 years old and surgery is supposed to be happened in late 30 when severe AR occurs so mechanical valve will be appropriate to ur case.till then I'm worried about for whole life taking the warfrinn in addition to this I'm very scary about complication associated with taking warfrinn for very long time because surgery is supposed to be in late 30.hope the technology advanced in the field of new and distinct valve production that lessen the complication of takin blood thinner and sound like tik tik .....hope God do all these thig very rapidly.thanku
@@deepaksinghsisodiya5690 hi, how is your valve now? I am from Bengaluru, found mine last month moderate regurgitation .
He’ll be doing my second surgery on Feb 12
Hi, i had mechanical mitral valve 7 years ago and on warfarin. Hope this research continues and give a solution to get rid from blood thinners for all type of valve replacement. Hoping for the best.
i guess im asking the wrong place but does anybody know of a tool to get back into an instagram account..?
I somehow forgot my account password. I would love any assistance you can offer me
@Alexis Messiah instablaster :)
@Fisher Junior I really appreciate your reply. I got to the site thru google and Im waiting for the hacking stuff atm.
I see it takes a while so I will get back to you later with my results.
@Fisher Junior it worked and I now got access to my account again. Im so happy!
Thank you so much you really help me out!
@Alexis Messiah Happy to help :D
Very exciting, received my On-X valve on July 27, 2020. Another excellent video Adam!!
Hey Chris! Hope all is great with you! Thanks for the kind words about the video. Dr. Gerdisch made my job easy. Take care and stay safe!!!
@@HeartValveSurgery So, I just completed 1 month on the PROACT Xa Clinical Trial! Feeling great and hoping Eluquis will become a long-term option for my mechanical brothers and sisters. :-)
I received my on x arotic valve six are seven years ago. I celebrated by walking the EL Camino de santiago in Spain at 64 years old. I walked 30 k.m per day. Averaged twenty miles a day for five hundred miles.. My picture is at onx headquarters in Austin Texas...
that's inspiring
❣️
Wonderful news... thank you.🇺🇸😎
Woow this is great news. At least there's hope to us
Got my mechanical heart valve in 2015. I really hope the day comes where I don't have get my INR checked all the time. Thanks for this video.
You, me and everybody else in here :)
so i am having double valve replacement surgery in October. I think i should now insist to my surgeon for On-X valve.
Hope it went well.
unfortunately mechanical Mitralic valves will always need Warfarin! This study is only for Aortic valve replacment.
My Name is Ted. I’m 36 I have a bicuspid aortic valve. I was diagnosed when I was a baby the doctor in the 80s wanted to proceed with surgery then my mother looking for a second opion took me to children’s hospital Oakland CA were the cardiologist recommended no surgery to wait because the advancement of technology in the cardiology field and my leak wasn’t the bad at the time. Now I’m 37 years old I live a very active lifestyle I am being recommended by Kaiser Permanente here in the Bay Area for my aortic valve to be replaced I am being told my heart has diolations and heart was pumping 60% in 2017 and. Is now pumping at 40%. To sum my story up. I’m scared. This video is great and has calmed me about my decease and surgery. I’m new to the channel and I have subscribed I wish dr girdish was in the Bay Area. And could do my surgery. Great channel very informative. I’m glad there’s this channel to help as myself and others take on these life challenges. Thank you.
Hi Ted, my father is 55 and was diagnosed with bicuspid aortic valve 4 years ago. We are also from the Bay Area and receiving care at Kaiser. I find some comfort in knowing we have that connection. My dad will have his surgery on 1/20/22 and will be getting the onx mechanical valve. I'm very nervous and want to provide him as much support.
Need to worry. I had my Mechanical Valve replacement in Mar 2022. I was scared to death, but later I realized it wasn't as bad I thought. A prick for the IV. Recovery takes a bit of time and eventually I went for a movie in about 3 weeks time post operation. Just stay positive. All will be well.
Very informative. I'm not a sufferer, but it's still great to know these things.
Thanks.
Great to hear you enjoyed this video with Dr. Gerdisch!
Thank you!
Thank you so very much for posting & sharing this video. I had surgery last summer (August 2020) and now have the On-X Aortic Heart Valve. I'm currently on Warfarin (1.5 - 2.0). It would be great to be able to replace Warfarin with a replacement blood thinner. I look forward to the follow-up video(s) on the progress of the PROACT Xa study.
Great to hear the video about the PROACT Xa clinical trial was helpful!!!
Hi please I have same on x do you take aspirin and warfarin together or only warfarin???????
I heard that one x is clicking to loud?That would be a big no no to me, luckly i have Italian valve Carbomedics. Noone don't hear it ( 3 fresh patients including me)
Thank you so much for the great video. I loved the way Dr. Gerdish explained everything, Adam you did a great job with the questions and getting the information. I received my On-X valve on Aug 12, the sound is a little bit uncomfortable but I don’t want to have another surgery. I told my Surgeon that I want to be part of the trial.
Thanks for the kind words Jose! I'll pass them along to Dr. Gerdisch. He made my job easy. I really learned so much during this interview. I especially liked learning about the pure pyrolytic carbon that Dr. Bokros made for the On-X mechanical valve. I am glad to hear that the PROACT Xa trial is of interest to you. So many patients do not know about these clinical trials -- including me. Take care and stay safe. If you need anything, please let me know!
Great information, thank you Dr. Gerdisch and Adam!!! I understood the doctor saying that most of his aortic valve surgeries are minimally invasive (non-sternotomy) - is that typically true for surgeries that require both valve replacement with aneurysm repair/replacement too? Am rooting for PROACT Xa!!!
Hey Bill, I just sent Dr. Gerdisch your excellent question. When I get a response, I will post it here. Stay tuned! Thanks!
Hi Bill, Quick follow-up to my earlier response. Amazing! Dr. Gerdisch immediately responded to your question! Here's what Dr. Gerdisch wrote to you, "Great question. Some aortic aneurysms are limited enough to be approached very well through a mini-sternotomy. Some work has been done replacing the aorta through the para-sternal incision (not touching the sternum) but the experience is small and the time on cardiopulmonary bypass relatively long. The most important concern remains a perfect operation, and in this case, ensuring all of the pathologic aorta has been removed. Surgical perfection should never be sacrificed for a smaller incision. If a stenotomy is required, rigid plate fixation of the sternum dramatically reduces the impact for the patient. -- Dr. Gerdisch". I hope that helps Bill!!!
@@HeartValveSurgery Really appreciate the quick response and detailed explanation. "Surgical perfection should never be sacrificed for a smaller incision" is very reassuring as I understand the short-term pain leads to long-term gain thinking. Mini-sternotomy's and Dr. Gerdisch's skill, experience, and great reviews are worthy of more research for me as I continue into year 12 of being in the "waiting room". Thank you again for providing this informative and hopeful video discussion!
i got st. jude aortic valve last 2015. and using warfarin to prevent blood clot. hope this research will help to to take coumadin.
Thanks for these updates! I'm facing my second valve replacement soon so I think I'm going with on-x!
Why you second time valve replesmentment..?
my mitral valve change 07/01/2021
Glad to help
@@mohammadsohel2672 I chose a tissue valve the first time and it's worn out
@@mohammadsohel2672 Hi brother
Ohhh
Be really nice if Canada would get on board and up to date !!!! We still haven't even adopted the new lower INR protocols from the original Pro-Act study!
When I had my surgery last June and being 22 I think one of the biggest things I had to get used to is taking a handful of medicine including warfarin. If I don’t have to take warfarin anymore that would blow my mind.
We agree!!! Take care and stay safe!!!
same, its honestly not that big an issue to stay alive but yes it would be amazing to not have to keep having blood taken to get checked.
I have had my On-x valve for almost 9 years now. I take warfarin and I self test my INR weekly. It would be great to be able to switch to Eliquis it would eliminate the need to stop warfarin before procedures and take Lovonox shots until I can start warfarin again and get my INR back in therapeutic range.
Thanks for sharing Bill!
I received my OnX arotic valve last week. 33 years old and been a super athletic my whole life. Is there a way i can participate in trails in Canada ?
Great question Umer. We do not know the answer. But, we found this email address that you can send a note to - proactxainfo@cryolife.com. Fyi, Cryolife is the medical company that is sponsoring the PROACT Xa clinical trial.
Did u have biscupid valve issue by birth? My son has it. Pls reply.
Hi you didn't speak about transcatheter valve please can you make another video about it that can patient should go for it and compare to there three valves which is best thanks
Hi Mohammad, Great point! If you go to the HeartValveSurgery.com CZcams Channel, you will see that we posted several educational and patient stories specific to TAVR. Here's a link - czcams.com/users/HeartValveSurgeryvideos. Hope that helps!
Where are we up to with replacing Warfarin in mitral valve replacement patients
my mother has the st jude regent valve will this treatment work with this valve ?
Hi Dappa, Unfortunately, the PROACT Xa clinical trial is not for the St. Jude Regent Valve. This trial is evaluating the On-X mechanical heart valve replacement.
I had a tissue aortic valve, when time come if I'm due for re-operation for replacement, can I have a mechanical valve?
Hi Dhinn, Great question. Yes, you can get a mechanical heart valve replacement if your tissue aortic valve wears out. Hope that helps!
Wondering if a larger dose of Niacin, (which inhibits clotting and reduces platelet counts), would be enough to be a substitute for Warfarin.
Do people with on-x valve take any other supporting medicine besides warfarin?like aspirin,clopilet??
KJ - Great question. Each patient is unique. We always encourage patients to ask their medical team what is best for them. However, specific to mechanical aortic valve replacement and the PROACT Xa clinical trial... That research study is using the use of Eliquis as the blood thinner instead of warfarin. Hope that helps!
Eliquis is what they have me on, I get valve surgery Oct 13th, but the thing is Eliquis costs $600 a month 60 tiny pills because the drug company has a patent and exclusive FDA approval, so no generics can be made, the patent expires in a couple of years
Hi Victoria, Dr. Gerdisch saw your post. Here's what he wanted me to share with you. Dr. Gerdisch says, "Patients enrolled in the study receive the medication for no charge, during the study. By the end of the study period or shortly thereafter, it is reasonable to expect the drug to be available in its generic form." Hope that helps!!!!
@@HeartValveSurgery That's great! thank you Dr Gerdisch and heartvalvesurgery!
I hope the eliquis/generic replacement for warfarin will wind up being approved since it sounds so much better to simply take 1-2 pills a day without having to go thru what I've read warfarin users have to.
I won't know until I wake up in the recovery room whether the surgeon was able to repair, or had to replace the valve.
It was different a few months ago when I knew surgery would come this year, but it sure made it a lot more real when an actual DATE was scheduled on the calendar! Now I'm counting down 3 weeks a few days left.
Thankfully my employer offers 90 days of "short term disability" paying 60% of your base pay, after that if one needed the long term it comes from insurance, but they directly pay the short term period.
@@HeartValveSurgery There is one other aspect of concern with this study, the skepticism in me looks at every angle, we still can't overlook the fact that Eliquis is very expensive- $600 a month for 60 tiny pills made by just one drug company that holds an exclusive FDA approval and a PATENT on it, the financial implications are of concern in that the financial stake in getting everyone switched over to this drug from cheap coumadin/warfarin is worth billions of dollars, do we have any assurances the drug maker has no hand whatsoever in this study, and that no one has been or is being offered any kind of "incentives" to approve this drug to replace warfarin?
Hi! Here is Dr. Gerdisch's response to your question:
"Great question. Medication in the US can be terribly expensive for the patients. It is a problem that needs to be solved, not only for Eliquis, but many other drugs that are absurdly expensive.
Fortunately, the patent for Eliquis is running out and the FDA has cleared the path for production of a generic. BMS can be expected to fight hard to prevent the generic from becoming available quickly, as they do make a ridiculous amount of money from the drug, but multiple companies will start making it. In other words, generic apixaban should be available in the next couple of years, depending on law suits etc that are pretty routine for huge companies trying to defend big profits. I do think Eliquis is a fantastic drug. I have been an investigator and consultant on the OnX valve for many years and have been reimbursed for my time consulting by the company who makes them. I have no financial ties to BMS. It is possible that an investigator has done research or consulting for BMS, but certainly not having substantial financial ties that would be influenced by the outcome of this study. In fact, all of the people who have OnX aortic valves would make up such a small fraction of the patients using the drug, it is unlikely to be very noticeable to BMS.
The science pointed us toward Eliquis. We could have used another of the non-warfarin anticoagulants, but believed Eliquis the best choice. They are all currently expensive. It just so happens though that Eliquis/apixaban may be the first of them available as a generic:
www.webmd.com/dvt/news/20191224/fda-approves-first-generic-of-popular-blood-thinner"
@@HeartValveSurgery That's good news, thanks so much for your detailed response Dr Gerdisch!
I did read where the patent was to expire I think in 2022, but while I don't know a lot about how patents work per sei, I know a lot more about copyrights- I understand that patents can be renewed somehow, but maybe to do that a certain amount of changes to the original design have to happen first, on a machine or software it could be fairly easy, which for a drug is not possible.
I guess I'm going to have to ask my surgeon that if he has to replace the valve- which valve make he prefers to use, and then if my insurance at work (Wellmark of Iowa) will cover what I'm sure is a more expensive device than "brand x".
I'm not sure I can just tell him "Dr, use On-X" I may not really have that option. From what I read, actual valves of any make cost around $5,000-$7,000
Hi it was such a useful information, I m 42 years old and I have dubble chamber on my right ventricle which creat narrowness to blood goes to lungs also miner aortic valve leakage, and my open heart surgery is due soon. My question is, is it possible that these problems can be fixed without open heart surgery I mean with keyhole surgery or any other procedure thanks
Samir bhai you from Pakistan
I saged you minimally ainvesve Karachi Pakistan
Yes I m from Pakistan
Zamir please inbox me
i am 27 years old change my mitral valve 07/01/2021
Who do we contact to try and switch to Eliquis? My family Dr or Cardiologist?
Hi Damon, Unfortunately, this clinical trial was stopped. You can learn more at this link - www.heart-valve-surgery.com/heart-surgery-blog/2022/10/05/proact-xa-clinical-trial-stopped/.
Is there any update on on th on-x
What about the tricuspid valve? Is there hope for patients with tricuspid valve regurgitation?
Hi, Did you watch this video about the tricuspid valve - czcams.com/video/PdAFBYqvlXw/video.html
Hope that hlelps!
Thanks! I'm praying there's hope for CIED lead related TR. I had multiple lead extractions and don't need an ICD anymore. Turns out after 6 years since overcoming the lead extraction and an incidental finding on echo, I have moderate TR and my cardiologist says I could casually monitor it. I was told that it's well tolerated unless it gets worse. My EP was more concerned about it but also said that great options don't exist at this point in time. I'm pretty worried now but haven't had any real symptoms and hope it stays that way. I'm also young, relatively speaking. Thanks for sharing the video. I didn't know about the Triclip.
Was wondering if this On x valve can be used for mitral valve replacement..
Great question Margie! There is an On-X valve for mitral valve replacement. However, it has not gone through the clinical trial process for lowered levels of warfarin. I imagine that might be happening in the future but I do not know for sure.
@@HeartValveSurgery thank you so much. I rely on you for so much information. Right now I'm in the watch and wait phase but it always helps to be informed. Again, thank you for everything. You are making a difference, for me and others.
@@margiestaneff568 You just made our day, our week, our month, our year!!!! Thanks so much for the very kind words Margie!!! If you need anything when/if you need your mitral valve replaced, please let us know. We'd love to help you along your journey to a healthy heart!!!
@@HeartValveSurgery oh goodness, thank you! I really feel just a little bit safer now. And more hopeful. Please continue to do what you're doing!
@@margiestaneff568 Hey Margie, We just learned the following from Cryolife, the company that manufactures the On-X valve, about their mitral valve replacement. Cryolife responded, "On-X® offers both aortic and mitral heart valves. The On-X valves are a newer generation heart valve made of a unique material and design characteristics compared with earlier generations of mechanical heart valves. www.cryolife.com/products/heart-valve-design-features/.
The On-X Mitral Valve is a part of an ongoing clinical Trial: The PROACT Mitral: Prospective Randomized On-X® Anticoagulation Clinical Trial. The PROACT Mitral Trial objective is to determine whether it is safe and effective to manage patients with less aggressive anticoagulation therapy than is currently recommended by ACC/AHA guidelines after implantation of the On-X bi-leaflet mechanical heart valve in the mitral position. clinicaltrials.gov/ct2/show/NCT00291525" I hope that helps!!!!
Hi sir please help me stuck prosthetic mitral volve
Sir ,I'm reahmatic heart deasease patient , waiting DVR serjary,my age 27 years. Mechanical valve or tissue valve which is better sir
CZcams heart valve choice, Ross, tissue, metal (onX or St jude)
Since your so young I would advise going with on-x valve..i was 44 when I had mine put in..they will recommend that for you because of your age..best of luck to you.
I have a mechanical valve surgery on Feb 12 !😅😅😅😅😅
I haven’t heard of any of those people
I am devendra singh my mvr st jude 33 surgery 1 year ago 12/2/22 but last December 20/12/22 sam broblem Dr talk yur prosthetic mitral valve stuck pleas help me yur advice pls
This man is reasonably asf
I was really hoping I would get an OnX Valve as I heard the ticking isn't nearly as loud as other valves. I had no idea the ONX could handle lower INR levels. I was given a St Judes valve at UCLA medical center in Los Angeles...I really wish I had the choice of ONX valve for the reasons that I am a very active 26 year old that does not enjoy the risks of bleeding...St Jude valve requires 2.5 to 3.5 opposed to a 1.5 to 2...
sorry but I don't understand English well, On-X valve is fine without anticoagulant (coumadin or warfarin ???) I had an operation in January 2020 and I have this aorta valve.
You need blood thinner/Coumadin. Ideally less Coumadin than other metal valves.
Got to take warfarin for now..if this study is successful..then you may be able to take eliquis
@@ethanl5956 maybe we have to wait so many years
I got this On-X mechanical valve in 2007 and now in 2024 I'm dying because I'm becoming anemic by the mechanical valve doors slamming shut and slowly killing my blood cells and my body now at 42 years old can no longer keep up with making healthy red blood cells and my muscles are wasting away to where I can barely move anymore and my oxygen levels will drop off quickly out of the blue for no reason at all and I don't even know what to do i even been told I need iron now too.
I'm so scared to have this done with all the research I'm still frightened I've known for a long time it would come with aortic stenosis but only being 37 I'm very afraid
Scary about the body rejecting the valve)
Guys this ist only for AORTIC valve replacemts. if you have a mitralic ONx Valve you will need warfarin for ever! Mitralic valves MUST be on warfarin alll the time!
To be honest, it doesn't have to be "equivalent" to warfarin. It only has to be "acceptable" in terms of thrombotic risk. Even if the risk is higher, as long as it is reasonable and no higher than that experienced by recipients of earlier valve designs (which honestly isn't spectacular), the decision should be left to the patient and his doctor rather than some governing body.
Daily warfarin is causing my bones to get weak :-( I wish I could stop taking warfarin
I have an onyx valve
It would be great not to take warfarin but Apixaban has such a short half life plus other downsides. I wish there were better drugs out there.
I am a sufferer