K
Karlynn
There has been quite a lot of mention of the promise of percutaneous valve replacement in the last several months, as a promise for the future of most anyone receiving a valve. Of late, it seems many members have reported doctors telling them that their next replacement may be percutaneous. I have become increasingly uncomfortable with new members being told that if they go with a tissue valve, their next replacement may be percutaneous. For me, this is like telling someone that eventually there will be a replacement for Coumadin or that the On-X will allow the person to not need it at all. It is science in the very beginning stages of study and is way too premature with PVR and no-warfarin On-X, to offer that as a foregone conclusion. And those of us that take Coumadin know that someday there will be a replacement for Coumadin, there have been some near misses in the past. But we are realistic enough to know not to hold our breaths.
From the reading I have done, the trials, which I believe began in '05 in the US, are being specifically targeted at high-risk patients over 70 who would not survive an open chest procedure. Great news for the people in this category, but far from a conclusion that it will be the standard for most needing VR in the future. From the reading I have done, there are intrinsic problems with these types of replacements that also must be assessed with each individual receiving one.
There is little/no data available to assume that this type of replacement will provide an option for valve longevity and functionality in those not considered high-risk. I'm suggesting that we be very cautious in presenting Percutaneous Valve Replacement as a consideration, particularly for anyone choosing a valve type that, given their age, will give them 10 years or less.
I'm including several articles for anyone who cares to read more (and assess why I'm uncomfortable with offering the Percutaneous Replacement promise/hope to our members. I started reading up on PVR after reading the enthusiasm here a while back and wondering if it also might be feasible in the future in replacing mechanical valves).
Here is a short clip from an interview done in Cathlabdigest.com in September of 2006.
Do you consider percutaneous aortic valve replacement a true potential alternative to surgical repair?
Not yet. I think the procedure is really in its infancy. I mean, it would be analogous to saying that balloon angioplasty was an alternative to bypass in 1980. It?s really not an alternative yet, because there are a lot of patients that are very good surgical candidates and there is no reason to use this experimental procedure on them. Surgery has had over 50 years of experience. With some of the bio-prosthetic valves there are implants that are now almost 20 years in duration. Until we have a better idea of the durability of the percutaneously implanted valve, I think it is way too premature to consider this an alternative. It?s a very good treatment for patients who are not good candidates for surgery. There are a lot of patients with severe aortic stenosis who simply are not suitable for surgery because they?ve got co-morbidities; for instance, severe lung disease, porcelain aortas, which are very heavily calcified aortas that the surgeons can?t cut into, and/or other co-morbidities like renal failure or liver failure, which makes surgery technically unfeasible.
http://www.ctsnet.org/sections/innovation/minimallyinvasive/articles/article-26.html
http://www.circ.ahajournals.org/cgi/content/full/113/6/771
http://www.news-medical.net/?id=31651
http://www.cathlabdigest.com/article/6212 9/06
http://www.edwards.com/newsroom/nr20050127a.htm
I apologize for being a wet blanket on this subject, but I do feel it is responsible for us to step back and reconsider telling our new members making a valve choice that their next replacement may/would be in the cath lab. Trials have just started in high risk patients and we don't know anything yet about whether it will be a viable option for the "average" person.
I think we are safest when using a philosophy where we recommend based on what medical science knows today. The future is always unknown. I would feel very uncomfortable in recommending an On-X valve to someone with the promise that they would not need to take Coumadin someday. I would, and have, offered that information as a possible point of interest, but I would, and have, always pointed out that it may not come to fruition. I would not want someone counting on it to occur, and I believe we should exercise caution and treat PVR in the same manner.
From the reading I have done, the trials, which I believe began in '05 in the US, are being specifically targeted at high-risk patients over 70 who would not survive an open chest procedure. Great news for the people in this category, but far from a conclusion that it will be the standard for most needing VR in the future. From the reading I have done, there are intrinsic problems with these types of replacements that also must be assessed with each individual receiving one.
There is little/no data available to assume that this type of replacement will provide an option for valve longevity and functionality in those not considered high-risk. I'm suggesting that we be very cautious in presenting Percutaneous Valve Replacement as a consideration, particularly for anyone choosing a valve type that, given their age, will give them 10 years or less.
I'm including several articles for anyone who cares to read more (and assess why I'm uncomfortable with offering the Percutaneous Replacement promise/hope to our members. I started reading up on PVR after reading the enthusiasm here a while back and wondering if it also might be feasible in the future in replacing mechanical valves).
Here is a short clip from an interview done in Cathlabdigest.com in September of 2006.
Do you consider percutaneous aortic valve replacement a true potential alternative to surgical repair?
Not yet. I think the procedure is really in its infancy. I mean, it would be analogous to saying that balloon angioplasty was an alternative to bypass in 1980. It?s really not an alternative yet, because there are a lot of patients that are very good surgical candidates and there is no reason to use this experimental procedure on them. Surgery has had over 50 years of experience. With some of the bio-prosthetic valves there are implants that are now almost 20 years in duration. Until we have a better idea of the durability of the percutaneously implanted valve, I think it is way too premature to consider this an alternative. It?s a very good treatment for patients who are not good candidates for surgery. There are a lot of patients with severe aortic stenosis who simply are not suitable for surgery because they?ve got co-morbidities; for instance, severe lung disease, porcelain aortas, which are very heavily calcified aortas that the surgeons can?t cut into, and/or other co-morbidities like renal failure or liver failure, which makes surgery technically unfeasible.
http://www.ctsnet.org/sections/innovation/minimallyinvasive/articles/article-26.html
http://www.circ.ahajournals.org/cgi/content/full/113/6/771
http://www.news-medical.net/?id=31651
http://www.cathlabdigest.com/article/6212 9/06
http://www.edwards.com/newsroom/nr20050127a.htm
I apologize for being a wet blanket on this subject, but I do feel it is responsible for us to step back and reconsider telling our new members making a valve choice that their next replacement may/would be in the cath lab. Trials have just started in high risk patients and we don't know anything yet about whether it will be a viable option for the "average" person.
I think we are safest when using a philosophy where we recommend based on what medical science knows today. The future is always unknown. I would feel very uncomfortable in recommending an On-X valve to someone with the promise that they would not need to take Coumadin someday. I would, and have, offered that information as a possible point of interest, but I would, and have, always pointed out that it may not come to fruition. I would not want someone counting on it to occur, and I believe we should exercise caution and treat PVR in the same manner.
. Since there are doctors that some have said believe that PVR is a certainty in the near future for low-risk patients, I would think there would be data or articles regarding application to confirm their statements. If not, it's not unheard of for even the best doctors to get a little over-exuberant with upcoming technology. I had one of the best cardiologist in the country for 18 years. He had a practice of 100 patients (of which I was blessed to be one) and spent the rest of his time doing research. Over the years I heard many promising things from him regarding medical technology. Some came to full fruition, some came to limited use and some didn't pan out at all. It's the nature of medical pioneering.
