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Percutaneous Valve Treatments (Dr Svensson 5 23 11)

Monday, May 23, 2011 - Noon

Description

Groundbreaking techniques are being developed to decrease mortality and morbidity from heart surgery. Instead of the large incision usually required for traditional heart or vascular surgery, percutaneous approaches treat the problem through small puncture sites through the skin. Percutaneous procedures are also constantly evolving and will one day provide patients with non-surgical treatment options. Learn about percutaneous treatments for valve disease with Dr. Svensson, cardiac surgeon at Cleveland Clinic.

More Information

Cleveland_Clinic_Host: Welcome to our "Percutaneous Valve Treatments" online health chat with Lars Georg Svensson, MD. They will be answering a variety of questions on the topic. We are very excited to have them here today! Thank you for joining us, let's begin with the questions.


Aortic Valve Repair or Replacement

genodoc: WHAT STEPS ARE BEING TAKEN TOWARD AORTIC VALVE REPAIR AND REPLACEMENT BEING DONE PERCUTANEOUSLY? WHEN CAN WE EXPECT TO BE THE PROCEDURE OF CHOICE?

Dr__Lars_Svensson: As far as aortic valve replacement, the current Edwards percutaneous device that we have been using in elderly patients will probably become available if approved by the FDA towards the end of the year for inoperable patients.

For patients who are at high risk for open surgery, typically minimally invasive surgery with us will take a longer time before it is approved and in high risk patients, the issue that the FDA will have to grapple with is that although the risk of dying from the procedure is the same, the risk of stroke was 3 x higher when the valve was inserted through the groin.

We have been working on filtering devices and techniques to reduce the risk of stroke with the percutaneous valves and undoubtedly that risk will be reduced over time. As far as repairs, the only option is an open minimally invasive repair.

fpilla: I am 78 and most likely will need an aortic valve replacement as echocardiograms show progressive disease since my initial diagnosis of aortic sclerosis in 1995 The last one in April indicates I am reaching the severe stage soon. I have developed atrial fibrillation in the last year. I also have hypertension. Otherwise I would not put myself in the High Risk category. Nevertheless I would prefer it if I were a candidate for an alternative minimally invasive approach. I am not short of breath nor do I experience dizziness. Recently my ankles seem edematous, but that may be due to Norvasc. Any hope that I could await the transcatheter approach?

Dr__Lars_Svensson: Based on your current risk profile, you would not meet the criteria for the percutaneous aortic valve procedure - Under the current continued access trial. For a minimally invasive keyhole operation, based on your mentioned risk factors, all other things being equal, I would quote you a risk of death with a minimally invasive procedure at 1% at Cleveland Clinic. This is much lower than the risk of death with a percutaneous valve including also a 1/3 lower risk of stroke.

Gene: What steps are being taken to make Aortic Valve Replacement a percutaneous technique? What about aortic valve leaflet repair. When can we plan on theses being the treatment of choice??

Dr__Lars_Svensson: As you can see, percutaneous aortic valve replacement has advanced tremendously since the early research we did in animal studies. When I was first involved in the transapical approach, we weren't sure how well it would turn out but to our great satisfaction, the results with percutaneous aortic valve replacement have been much better than expected.

As far as aortic valve leaflet repair with a percutaneous approach - I don't foresee that happening for quite a long time. However, in a study that will be published in the Journal of Cardiac and Thoracic Surgery in the next month, we have shown that aortic valve repair produced a better survival rate approximately 7 years after surgery when compared to aortic valve replacement and that the risk of reoperation for failed biologic valves is better approximately 10 years after repair or replacement.

Sandra: My 83-year-old mother has asymptomatic aortic stenosis. She would very much like to get as minimally-invasive a procedure as possible, as she is still caring for her husband, 85, who has dementia. At what point could she be considered a candidate for this new treatment option? Is it best for her to wait as long as she can in hopes of having percutaneous, or have the min-invasive prior to developing symptoms?

Dr__Lars_Svensson: At this stage, she would not be a candidate for percutaneous valve since she does not have symptoms. It would be better to wait till symptoms occur.

Diana: Is anyone doing the TAVI procedure that is NOT part of a clinical trial? My husband needs a valve replacement and is not strong enough for surgery. Doctors in the clinical trials will not allow him to become a patient because he is on dialysis. Thank you.

Dr__Lars_Svensson: Currently in the U.S. patients on dialysis are not enrolled in TAVR trials. The only option is either a balloon valvuloplasty of the valve or having it done in Europe.

Carolyn: I have been told by my cardiology surgeon that I need a replacement of my aortic valve because of severe aortic stenosis. How many successful non-surgical procedures have you done to repair this kind of problem, and what kind of recovery time is needed after going through the non-surgical repair of a leaky aortic valve? Is there an estimate as to how long the repair lasts? What is the pain involved in the procedure and the recovery? Would travel of about 1200 miles back home by car be alright after going through the procedure to repair the aortic valve, and how many days of recovery would be needed before starting the long trip back home to Venus, Texas. Thank you for your helpful information.

Dr__Lars_Svensson: We have done about 190 patients and in the PARTNER trial we had no deaths. Typically patients are in the hospital about 5 days after the procedure but it requires at least 2 trips to get the procedure done. This procedure is reserved for inoperable or high risk patients who meet the entry and exclusion criteria.

lmgaiso: How many percutaneous aortic valve replacements have been done to date? Same question for mitral valve?

Dr__Lars_Svensson: There have been approx. 3,200 percutaneous aortic valves done in the U.S. They have only been done for inoperable patients or high risk surgical patients. The PARTNER trial showed that for high risk patients, the risk of death was the same but the risk of stroke was 2 - 3 times higher in TAVR. Percutaneous mitral valve clip treatments have been considerably less often done in the U.S..

Michaelanthony: How many percutaneous aortic valve replacements have been performed to date?

Dr__Lars_Svensson: The total worldwide experience is now between 30 and 35,000, the majority in Europe.

marksg: I am 58 and have bicuspid aortic valve which is now stenotic. Opening is down to 1.2cm but not symptomatic yet. Am I a candidate for replacement by percutaneous process?

Dr__Lars_Svensson: For 3 reasons, you are not a candidate:

  1. You have a bicuspid aortic valve
  2. You have no symptoms
  3. You are too young

fpilla: How do you decide between a minimally invasive aortic valve repair vs replacement?

Dr__Lars_Svensson: There are 2 answers to your question. I do all aortic valve replacements and ascending aorta replacements with a minimally invasive keyhole J incision. I also use the minimally invasive incision for most patients who have aortic valve repairs. The exception would be for the David Aortic Valve reimplantation and repairs. for the safety value it is better to do a regular incision for these patients.

razor: what has been your experience with patient recovery experience (time-discomfort) from percutaneous aortic valve replacement

Dr__Lars_Svensson: For the patients with the transfemoral percutaneous valves, recovery has been quick unless there has been injury to the femoral artery during the procedure. For the transapical approach, patients have tended to take a little longer to recover but that may be a reflection of the transapical patients being sicker than the transfemoral patients. The PARTNER A trial showed the transapical patients had more peripheral vascular disease, had had coronary artery bypass procedures more often, PCI more often, carotid endarterectomy more often, had more cerebrovascular disease, more atrial fibrillation, and more severe aortic valve stenosis. All markers of a greater atherosclerotic burden.

marksg: In case of stronger low risk patient who doesn't care about surgical scars or recovery time, is it generally better to have an aortic valve replacement done by full sternum cut rather than robotically or by window (through the rib) approach (that is, to give the surgical team a much bigger working area)?

Dr__Lars_Svensson: We have a paper coming out in the journal of cardiac and thoracic surgery showing that there are benefits to a minimally invasive aortic valve replacement when compared to opening the whole chest, particularly in patients with lung disease. In our experience at Cleveland Clinic for aortic valve replacements, we were unable to show any downside.

Baseball23: Is Cleveland Clinic the best place for an aortic valve replacement

Dr__Lars_Svensson: We do approximately 1,500 aortic valve replacements per year. In the last analysis of Cleveland Clinic data when compared to the STS national data base, patients at Cleveland Clinic had 1/3 the risk of dying when compared to the national data including risk adjustment. On average a cardiac surgeon in the U.S. does only 8 aortic valve replacements in a year. At Cleveland Clinic, several surgeons do more than 200 and even 300 per year.

TedSon263: Can the percutaneous aortic valve be a tissue valve?

Dr__Lars_Svensson: The leaflets are a tissue valve.


Aortic Valve Reoperation – Percutaneous Procedure

Aidan: In ten years do you think you'll be doing second percutaneous valve replacements routinely? I am now 67 and had my aortic valve replace one year ago.

Dr__Lars_Svensson: Yes. We have already done 8 valve in valve operations where we have put a new percutaneous valve in a previous percutaneous valve, inserting a percutaneous valve in a previously open inserted aortic valve is more difficult and we are waiting for the development of a new device that will make it easier to do.

sandydee8: Dr. Vaughn Starnes did open heart surgery consisting of a human aortic valve replacement, aorta repair and a Maze procedure 5 years ago (my son was 43). My son exercises vigorously every day and has been told that his veins and arteries are perfectly clear. He suffers from shortness of breath, frequently, however, and also hemiplegic and ocular migraines. We are wondering about life expectancy and also whether my son would be a candidate for less invasive surgery should this transplant fail. Thank you.

Dr__Lars_Svensson: I presume that you mean that he had a homograft aortic valve inserted. We are hoping that towards the end of this year or early next year, we will be allowed by FDA to start putting percutaneous valves into previously inserted homografts. However, if your son has increasing shortness of breath, I would highly recommend that he goes back and sees Dr. Starnes again. If he should need another operation, Dr. Starnes would do an excellent job at doing a safe reoperation.

James: My wife has a 21MM Edwards Magna aortic valve in place. Is her valve too small to be eventually replaced by a percutaneous valve?

Dr__Lars_Svensson: Based on current research, a 21 valve will probably be too small to do a valve in valve procedure. However, for most patients who are not elderly or have severe comorbid disease, I usually quote a 2% risk of death for a reoperation. Which is higher than for a primary procedure, the latter carrying a 0.5 - 1% risk of death at Cleveland Clinic.

Sept14: Hello. Thanks so much for sharing your knowledge today. I am a 36 year old male now 8 months post surgery - aortic aneurysm graft and 27mm pericardial tissue aortic valve. Other than a pacemaker, I had no complications after surgery and doing just great now. My question is: I know no one can guarantee anything about percutaneous valve options in the future, in your best medical "guess", if my tissue valve lasts me 10 years, do you think percutaneous could be a reasonable option? If so, and if tissue again, how about for a future operation 10-15 years later? Again, I understand no guarantees, just wondering what expectations and hopes are based on trial evidence so far. Could percutaneous theoretically be a lower risk (compared to open heart or minimally invasive) procedure for young patients also someday, not just the elderly who have other risk factors making open heart not a good option. Thanks so much.

Dr__Lars_Svensson: The likelihood is that in 5 years in time, we should have a valve in valve device for your situation. Furthermore, since you had a large size valve inserted, you probably I am guessing would be able to have another valve in valve and still have a good hemodynamic response. I doubt that in the next 5 years the percutaneous valves will become as safe as open surgery in young patients less than age 70 or without co-morbid disease. The main reason being that the percutaneous valves crack the calcium in the aortic valve which is then pushed aside for the new valve with the potential risk of pieces of calcium breaking off and going to the coronary arteries to the brain.

Don_M: I am a 58 year old male. My aortic valve was replaced 25 years ago in 1986 with a St. Jude mechanical valve, model # 27A-101. My native valve, a congenital bicuspid, was replaced a little more than a year after a serious battle with sub-acute bacterial endocarditis. Since that time I have had a moderate/severe mitral valve prolapse which has been followed by my cardiologist. Although I've shown no symptoms, a recent echo is beginning to show signs headed to mitral valve repair or replacement. Are there any less invasive techniques available for this procedure?

Dr__Lars_Svensson: At the age of 58 and no other co-morbid disease, the only option is an open re-operation.


Mitral Valve Surgery

JJAltoona: Hello. My wife had surgery performed by Dr. Cosgrove to repair her mitral valve 14 years ago. The surgery was done via a minimally invasive incision and a Cosgrove ring was implanted. The valve is now leaking enough that another surgical intervention might be required. Does the fact that she has already had surgery with the Cosgrove ring implanted automatically rule out the percutaneous procedure? Also, am I guessing correctly that her only option now will be to have the valve replaced, or can a second repair be performed? Thank you!

Dr__Lars_Svensson: The fact that she had a previous mitral valve repair does not exclude another repair but the chance is about 1/3 of having another repair. She would not be a candidate for any type of percutaneous procedure.

FloppyValveMom: Hi:). I am 28 years old and was diagnosed with severe mitral valve regurg. a year ago. I have pretty bad symptoms but am not mentally ready for surgery. I am holding out for a less invasive procedure than now. So my questions are 1) Is there less invasive procedure that is almost perfected? 2) By waiting am I causing more harm to my mitral valve that may prevent it from being repaired in the future?

Dr__Lars_Svensson: There are no percutaneous procedures that will be available for someone as young as you in the foreseeable future. Yes - you are putting yourself at risk by delaying surgery and considering that you have symptoms, the likelihood of repair will diminish over time and you could also run into more serious complications such as poor left ventricular function and atrial fibrillation.

In a study we did with minimally invasive procedures, there was 100% survival and now a day, with a minimally invasive mitral valve or robotic procedure, your length of stay in the hospital is likely to be around 2 - 5 days. Furthermore the durability of the repair is better than any percutaneous procedure. In the last 850 robotic mitral valves, we have not had anybody die - in other words survival is 100%.

mvpr: Why choose Cleveland Clinic for mitral valve repair? (live in AZ)

Dr__Lars_Svensson: The reason to choose Cleveland Clinic is because we have the biggest experience with mitral valve repair in the world and in the last two years we have not had a death from mitral valve repair surgery and we do well over 1,000 per year.

shones: Can mitral valve repair/replacement be done with this method?

Dr__Lars_Svensson: The percutaneous aortic valve can be inserted into a previous mitral valve replaced valve going in through the left ventricle apex. There is however a lot of research ongoing on both mitral valve repair or replacement with newer devices. But, with the exception of previous valve insertions the aortic valve device cannot be used.


General Percutaneous Questions

Michaelanthony: When do you expect percutaneous valve replacement to be practiced widely?

Dr__Lars_Svensson: This is a very difficult question to answer. We will be rolling out another 10 Centers for the Edwards trial in the next few months. But - ultimately the goal will be for many more sites. However, we feel very strongly that patients need to be evaluated by a well functioning multidisciplinary team and that the valves should also be inserted by a multidisciplinary team in hybrid operating rooms that are properly equipped to manage these new demanding procedures.

Michaelanthony: To date, has the FDA testing uncovered any serious issues that would delay acceptance?

Dr__Lars_Svensson: We have analyzed the Edwards data very carefully including I have reviewed all the deaths after the PARTNER B trial. At this time, as far as results related to the durability of the valve have been good. There are however the procedure related complications and that data is also available to the FDA. At this time, we are unaware of any problems that have not been detected by us in the analysis of the data that FDA may have found on examination of the same data.

WPS10024: pls explain what percutaneous valve treatment is

Dr__Lars_Svensson: We refer to this treatment as making a small cut in the skin and then using catheters and guide wires to insert a new valve remotely either from the groin or through the chest wall.

tbivanc: How important is pre-planning TAVI procedures and what imaging modalities are favored currently (CT, MRI, TEE)

Dr__Lars_Svensson: TAVR requires much more testing and screening before the procedure than regular open minimally invasive surgery. At the moment, that includes CT, transthoracic echo, often TEE, cardiac catheterization and pulmonary function testing.

eugenejung: Can you provide us with an up to the minute view on the types of procedures that can be done percutaneously?

Dr__Lars_Svensson: As far as which procedures can be done percutaneously, although some should not be done percutaneously - these include atrial septal defects; pulmonary artery stenosis; mitral valve procedures; aortic valve procedures; and aortic aneurysms in the cardiovascular field. There are other areas such as carotid arteries and peripheral arteries that can be done in this manner.


Robotic Heart Surgery

Michaelanthony: What is the survival rate for robotic minimally-invasive aortic valve replacement? How many of these procedures have been performed?

Dr__Lars_Svensson: At Cleveland Clinic, we have done approx. 850 robotic mitral valve replacements without a patient dying. In the last two years we have not had a patient die of a mitral valve repair irrespective of the approach. Approximately because of additional procedures, 1/4 of patients are done with a standard incision; 1/4 with a minimally invasive J incision; 1/4 with a right chest thorascopic approach and 1/4 robotically. [author note - this reply is for robotic mitral valve - we do not perform robotic aortic valve ]

lmgaiso: When you say "In the last 850 robotic mitral valves, we have not had anybody die", are you referring to only surgeries at Cleveland Clinic? How different is it under the country?

Dr__Lars_Svensson: The 850 robotic cases refer to Cleveland Clinic surgeons. There are only a few centers that regularly do robotic mitral valve procedures. I would suggest you look up their published results.


General Heart Surgery Questions

mvpr: Is it preferable to have cardiac cath performed at Cleveland Clinic if considering mitral valve repair there? My echo indicates moderately severe regurgitation as of 5/19/11. Thank you.

Dr__Lars_Svensson: For most patients, I recommend they have a catheterization done at home because that would allow your kidneys to recover from the cath dye load before having surgery.

Cleveland_Clinic_Host: I'm sorry to say that our time with Dr. Svensson is now over. Thank you again for taking the time to answer our questions about percutaneous valve treatments.We received many questions and apologize that we weren't able to get to all of them.

Reviewed: 05/11


This information is provided by Cleveland Clinic as a convenience service only and is not intended to replace the medical advice of your doctor or health care provider. Please consult your health care provider for advice about a specific medical condition. Please remember that this information, in the absence of a visit with a health care professional, must be considered as an educational service only and is not designed to replace a physician's independent judgment about the appropriateness or risks of a procedure for a given patient. The views and opinions expressed by an individual in this forum are not necessarily the views of the Cleveland Clinic institution or other Cleveland Clinic physicians.

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