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Percutaneous Treatments for Valve Disease (Dr. Tuzcu 4/12/10)

Tuesday, April 13, 2010 - Noon
Murat Tuzcu, MD

Murat Tuzcu, MD
Vice-Chairman,
Department of Cardiology in the Sydell and Arnold Heart & Vascular Institute, an Interventional Cardiologist at Cleveland Clinic.

Description

Instead of the large incision required for traditional heart or vascular surgery, percutaneous approaches use special catheters and devices to treat the problem through one or more small puncture sites through the skin. Many new percutaneous procedures are evolving that will provide non-surgical treatment options for patients in the future. Learn about percutaneous treatments for valve disease with Murat Tuzcu, MD, Interventional Cardiologist at Cleveland Clinic.

More Information

Cleveland_Clinic_Host: Welcome to our Online Health Chat with Cleveland Clinic interventional cardiologist Dr. Murat Tuzcu. Thank you for joining us Dr. Tuzcu, we are thrilled to have you here this chat. Let’s begin with the questions.

Speaker_-_Dr__Murat_Tuzcu: Thank you for having me. We have many questions today.


Percutaneous Valve Treatments

MikeG: Suppose that precutaneous valve procedures become widely available. How long will it take to determine whether precutaneous valve replacement will be durable long term as surgical valve replacement? I understand that a tissue valve replacement lasts for 10 to 15 years. Will it be necessary to wait the full 10-15 yrs to answer that question? How much will we really know about long term durability 2 to 3 years after precutaneous valve procedures become widely available?

Speaker_-_Dr__Murat_Tuzcu: Long term durability of the aortic valve prosthesis is a concern to all of us. The edwards sapien valve that is being tested in the U.S. is produced by a company that has been manufacturing heart valves for decades. the leaflets of the prosthetic valve is almost identical to the modern surgical replaced valves. Thus - the hope and the expectation is that they will last as long or as nearly as long as the surgically implanted valves.

This expectation is supported by the extensive bench testing that shows the durability of this valve. Having said these, there is no doubt there is an element of uncertainty because these valves are attached to a metal stent and crimped to a balloon and expanded in the body. Thus it is a different types of forces that influence this particular valve.

The short answer to your question - we will carefully monitor the durability of the valve on an ongoing basis. I am happy to tell you that currently there is no evidence of structural failure in the few years we have had experience with this valve.

CaroleL: Questions: (1) It is my understanding that these treatments are currently restricted to a "clinical trial" When will this procedure be available for an otherwise "healthy" person that has severe aortic stenosis requiring aortic valve replacement versus minimally invasive or open heart surgery procedures? (2) Is it, or will it ever become, as good as the minimally invasive or open heart surgery procedures?

Speaker_-_Dr__Murat_Tuzcu: The current trial that is testing aortic prosthesis via catheter to the standard surgery involve patients who are either deemed to be prohibitively high risk for standard surgery or those that can be operated but have a risk of dying after surgery 10 - 15 % or higher.

These are the first and second generation catheter based valve delivery systems. Like many other innovations in medicine I believe technical hurdles will be surmounted and in the future they will be an alternative to minimally invasive or open heart surgery for many patients - but I should add percutaneous aortic valve surgery for low risk patients is not the subject of current or near future consideration. One reason for that is in centers such as Cleveland Clinic aortic valve replacement can be carried out with less than 1 % risk of mortality.

TrevorB: Questions for the chat.. How does percutanious valve repair impact on visualization and access to the surgical field. Can i have statistics on valve repair success/complications.

Speaker_-_Dr__Murat_Tuzcu: One of the first prospectively collected data comes from a study conducted by three centers in the U.S., Cleveland Clinic being one of them. In only 55 patients, who underwent aortic valve implantation using a catheter inserted from the groin, the risk of mortality at 30 days was 7.3%. These were mostly patients that could not be operated on because they were at very high risk of dying or having serious debilitating problems should they undergo surgery. Average age was 83 years. Since then, reports from Europe and Canada show that equally high risk patients can be treated with this technique with a mortality risk of 6 - 10%.

Kathleen: Can you use percutaneous valve treatments on leaking heart valves?

Speaker_-_Dr__Murat_Tuzcu: Percutaneous valve treatment for aortic valve is focused almost exclusively on narrow aortic valve. If an aortic valve's main problem is leakage, and if it needs treatment, for the time being, surgery is the only option. On the other hand, there is a lot of activity going on for the repair of the leaking mitral valve via catheters.

Martin: If I come there for percutaneous treatments, can I get all the testing at home or do I need to go there for testing before the procedure? What about follow-up? Can my home doctor do the follow up testing?

Speaker_-_Dr__Murat_Tuzcu: Currently transcatheter valve treatments are only done as part of the clinical investigations as none of them are approved. These clinical trials require some testing to be done in the specific center and all require return of the patient to the center periodically for a systematic follow up.

Marge: If I have a pacemaker would I be a candidate for a percutaneous valve?

Speaker_-_Dr__Murat_Tuzcu: Pacemaker is not a contra-indication for percutaneous valve treatment. There is very limited experience in placing valves in previously implanted heart valves. All of these patients underwent this procedure because they were very sick and turned down for a repeat open heart surgery and this experience is from exclusively outside the United States.

Frank: I had valve surgery 8 years ago and now I have a narrow valve requiring surgery. Can I still be a candidate for percutaneous valve procedure?

Speaker_-_Dr__Murat_Tuzcu: For some reason this question did not go through - the answer has already been sent through

Susan: My mom is 95 years old and she needs valve surgery. Is there a cut off age for this procedure or would she still be able to have this?

Speaker_-_Dr__Murat_Tuzcu: there is no age limit for the trial testing transcathetier aortic valve implantation. As a matter of fact we have patients over 100 enrolled in this trial.

Steven: Is the percutaneous valve covered by insurance? If not - how much does it cost?

Speaker_-_Dr__Murat_Tuzcu: Many insurance companies cover investigational percutaneous valve treatment. Obviously it should be checked with your particular company before proceeding.

StuartL: My brother has had kidney problems and has been on dialysis. Now he needs valve surgery and I am worried about him going through open surgery. Would he still maybe be a candidate for percutaneous if he is on dialysis?

Speaker_-_Dr__Murat_Tuzcu: Many trials exclude patients who are on dialysis.

Mary: How long are you in the hospital after percutaneous valve surgery?

Speaker_-_Dr__Murat_Tuzcu: You stay in the hospital 2 - 5 days after percutaneous valve surgery.

MaryK: I had a catheterization a few years ago and was awake the whole time. Are you awake during percuteneous valve surgery because that is a catheter procedure too?

Speaker_-_Dr__Murat_Tuzcu: It is performed under general anesthesia


Mitral Valve – Percutaneous Valve Procedures

KevinB: I was recently diagnosed with Mitral Valve Regurgitation. Do you offer the new "clip" surgery there yet? I am to go back to my cardiologist in 6 months for another echocardiogram to track any increase in my regurgitation that may occur from now until then. I am currently considered moderate to severe in my regurg. I want to have the most minimally invasive surgery performed when the time comes for me to have surgery. If I obtain "cd's" of the tests I've had done so far, can I send them to someone there for review and an opinion? I am currently asymptomatic but both sides of my mitral valve are not closing properly. I've had an echo done, a TEE, a stress test, and lab work. Thank you, Kevin - Age 49

Speaker_-_Dr__Murat_Tuzcu: The mitral valve repair via a catheter using "clip" has not been approved in the U.S.. Within the last month, the results of a randomized trial was reported. Based on the information from a relatively small group of patients that were studied, clip appears to be promising in selected patients.

It is different than minimally invasive surgery. Surgical repair of the mitral valve as long as they are suitable for repair is extraordinarily successful in centers with expertise. For example, at the Cleveland Clinic, the chances of a successful repair is close to 100 % with risk of mortality less than 1 in 1000.

We will be happy to review the information that you can provide us including the pictures and movies of the echocardiograms to assess if you would be suitable for minimally invasive surgery repair.

SusanT: Percutaneous Valve Placement 1. When do you anticipate this procedure becoming available to public? 2. How does one become a candidate to participate in a clinical trial? 3. How valuable is a TEE in establishing how the mitral valve might be repaired?

Speaker_-_Dr__Murat_Tuzcu: Percutaneous valve replacement is still an investigational tool. It is impossible to know when the device will be approved or if it will be approved. We will know more as the results of these trials become available in the years to come. Patients who are found to be at high risk for aortic valve replacement surgery are referred to centers who participate in the PARTNER trial - Cleveland Clinic is one of them. They undergo examinations by a cardiologist, heart surgeon, and a battery of tests.

After this comprehensive evaluation, we determine if the patient is a candidate for surgery or not; what would be the expected risk for surgery; and if they are at high risk - do they fulfill the criteria for enrollment into the PARTNER trial.

For the mitral valve repair using a clip, which is currently done within the context of a clinical trial, TEE plays a very important role to define the anatomy of the valve. It helps us to identify the patients that the clip can be used successfully.

mark: Hello: I underwent in Nov. 2009 an attempt to implant a mitraclip device to remedy my MV that was unsuccessful. The reason given was that it did not "adequately reduce" the regurgitation level. Could you define what is meant by "adequate regurgitation level" what parameters define it and the values of these parameters? Also what is the rate of failures of the mitraclip? Thanks, Mark

Speaker_-_Dr__Murat_Tuzcu: Mitral regurgitation is graded from 1+ being the least severe to 4+ being the most severe. Semi quantitative measures are used. Based on the echocardiograms within the context of the clinical trial in the U.S., success was defined as 2+ or less. Overall experience in the world suggest that 80% of patients or higher derive benefit from this procedure. Most importantly, if the clip procedure is not successful, most of the patients preserve their chance of surgical mitral valve repair.

Graphiclady: Does the Evalve really improve outcome as much as surgery?

Speaker_-_Dr__Murat_Tuzcu: It is important to note that the evalve was tested in the U.S. in a very select group of patients and the follow up that is available for one year. In centers experienced in surgical mitral valve repair there is extensive short and long term experience. However these results are not controlled. I would describe evalve results are very encouraging. If it is approved, it will be another tool in our tool box but it is by no means a replacement of an expertly done surgical repair.

vintal: Hello, I was seen at the clinic in august of 2008 for severe mitral regrgitation. I was going to have robotic surgery but the doctors decided to wait one to 10 years depending on the progression. I would like to know if I could have the mitra clip procedure or what new options might be available. Thank you

Speaker_-_Dr__Murat_Tuzcu: Currently there is no FDA approved in the U.S. that can be used for mitral valve repair. In the future it may be available for a select group of patients. On the other hand, there is extensive experience with standard or minimally invasive mitral valve repair with or without the help of robotic technology. Excellent results with extraordinary safety have been proven in experienced centers such as U.S.. It appears that your condition a period of watchful waiting will allow you time for gathering more information on this topic.

sunflower_ca: 1. I have severe mitral stenois (45 yr old, mitral area is 0.8cm2). When is the right time to have PMBV or surgical commissurotomy?

Speaker_-_Dr__Murat_Tuzcu: The decision for ballon valvotomy or surgery for mitral stenosis is based on, to a great extent, the patient's symptoms. There are some other criteria but foremost is the onset of symptoms that limits the daily life tells us the time for intervention has come. If the valve is suitable, balloon valvotomy is preferable because of its noninvasive nature. There are half a dozen studies that it is equally or more effective than surgery in short or long term. In the U.S. it is a very small group of patients that require this procedure because of eradication of rheumatic fever.

sunflower_ca: 5. How many PMBV procedures have been done at the Cleveland Clinic in year 2009, and what is the success rate? What would be done if the PMBV is failed? Surgery? Does a patient need to meet a surgeon before the PMBV just for in case?

Speaker_-_Dr__Murat_Tuzcu: Approx. similar number done in 2008 and 2009.

sunflower_ca: 6. I understand the most common risks for PMBV are embolic events to brain and mitral regurgitation. Is there any new technology can minimize those risks?

Speaker_-_Dr__Murat_Tuzcu: Brain embolism is very rare with balloon valvotomy procedure.


Aortic Valve – Percutaneous Treatments

shaneme123: I understand there is a higher risk of complications with percutaneous treatments versus traditional open-heart surgery. Can you comment on why and what is being done to reduce said risks?

Speaker_-_Dr__Murat_Tuzcu: We have no data that suggests risk of complications is higher with percutaneous treatments vs. traditional open heart surgery because most of the people who underwent percutaneous treatments in the U.S. would never be operated on because of extreme high risk. The results of the randomized PARTNER trial will tell us about the risk of this procedure vs. just treating patients by medications and risk of this procedure vs. high risk open heart surgery in those who could be operated on.

shaneme123: Where are we at in the maturity scale regarding Percutaneous Treatments related to aortic valves? Meaning, are we just at the cusp of great progress (e.g. higher risks) or leveled out (e.g. moderate risk; best we can do right now)? Trying to gauge whether it makes sense to wait for these types of procedures to mature more or jump in. Also, how do you see the success of these types of procedures advancing in the next 3-5 years?

Speaker_-_Dr__Murat_Tuzcu: The tools that we currently use are second and third generation devices. We certainly are not leveled out in our progress in this field.


Perivalvular Leak: Percutaneous Treatments

fhawk: I have had 2 aortic valve replacements in 3 years, both porcine, Medtronic; the first tore in half in less than 18 months. When the second valve was put in there was considerable bleeding (10 units replacement on the OR table) and scarring, and as such the valve was partially attached to the right ventricle. It has leaked in a paravalvular manner almost since being seated. I have 6 monthly echos and try to keep my BP low with beta blocker and Diovan. So, is there is a percutaneous way to repair a perivalvular leak such as this? Two (additional) surgeons have told me that I could not undergo a third open heart surgery (although I'm only 57 and otherwise healthy, female). When would the threshold for that be met--i.e., what diagnostic criteria? Thank you.

Speaker_-_Dr__Murat_Tuzcu: The leakage of the valve between the frame of the valve and the wall of the aorta is not very common but when it happens it may be a very serious problem. It can cause heart failure, sometimes it chews up blood cells and leads to serious anemia and frequent blood transfusions. Indeed many patients are at high risk for repeat surgery. More over, recurrent leakage after a repeat surgery is a serious risk. We do not have a perfect solution but we have a way of putting tiny plugs into the holes between the wall and the frame of the valve. Many of these patients show significant improvement even if there is residual leakage that remains. We will be happy to evaluate you for perivalvular leak.

fhawk: Maybe my question isn't getting through--are there percutaneous procedures for perivalvular leakage repair of an aortic valve replacement?

Speaker_-_Dr__Murat_Tuzcu: Yes - through the catheter inserted via the artery in the groin we place tiny plugs that are made of a metal mesh into the holes between the valve frame and the aortic wall. With this technique we aim to obliterate the spaces that leakage occurs.

Speaker_-_Dr__Murat_Tuzcu: No minimally invasive surgical techniques are available.

mlariau: Hello Dr Tuzcu: I am French 44 years old and I need an AVR. For me the big topic is mechanical or biological (I'm fully asymptomatic, do sports, travel and very active). French cardiologists are very scared of a second surgery. Nowadays percutaneous treatments are not available for profiles like mine. Apparently percutaneous treatment can apply to repair valve (biological or original) once , but we can't use back this technique (impossible to pull out) ? Is it true ? My cardiologist plans 44 years old surgery for biological AVR, 54 percutaneous treatment and 64 years old 2nd surgery too risky? Can't percutaneous treatments help me to find out a more optimistic plan? Thanks for your lights.

Speaker_-_Dr__Murat_Tuzcu: It is a tricky situation. Both mechanical and biological valves have their advantages and disadvantages. Some experts think that nowadays we should be more open to bioprosthesis for younger people such as yourself because we will be able to treat them percutaneously even if they fail 10 years later.

That is very hopeful thinking but it is currently not supported by data. Certainly in our institution, repeat open heart surgery for a second aortic valve replacement carries the same risk as the first open heart surgery provided that there no serious high risk characteristics. Thus you should make your decision based on the risk that coumadin will pose with your particular lifestyle vs. the risk of requiring a second open heart surgery.

waterford: I am a 51-year old male with a regurgitant bicuspid aortic valve. There is no stenosis. I am supposed to have surgery to replace the aortic valve within the next month. I do not want to face this surgery again, but i am concerned about a lifetime of cumadin. Are the prospects for percutaneous aortic valve replacement promising enough to choose a tissue valve at my age so that it can be replaced in 10 to 15 years by a percutaneous procedure and feel confident that I can avoid another surgery?

Speaker_-_Dr__Murat_Tuzcu: As I just mentioned in my previous answer - it is our hope that in the future we will be able to use percutaneous techniques to treat the failed surgically implanted bioprosthetic valves but we need much more data and experience in this field.


Tricuspid Valve Disease - Percutaneous Treatments

sevyressag: I've had mitral valve surgery twice. Now I have severe tricuspid regurgitation. Can this procedure be used in my case? Also how does one become a candidate for trials?

Speaker_-_Dr__Murat_Tuzcu: For the time being there is a lot of experimental work being done for tricuspid valve but unfortunately there is no current or near future clinical trial for percutaneous repair of tricuspid regurgitation.


Mitral Valve Disease

clara: I take the cleveland clinic heart letter, and the latest one had an article about mitra valve regurgitation being looked at differently without symptoms. I have moderate regurgitatiion. I have symptoms from blockages, and I am not sure I would ever know if I had any symptoms. Should moderate be followed?

Speaker_-_Dr__Murat_Tuzcu: Sometimes symptoms may be the result of more than one problem. Your moderate mitral valve regurgitation should be followed together with the coronary disease.

roullac: Hello Dr Tuzcu, I have had mitral valve repair via Median Sternotomy in August 2009 although I was hoping that this would have been done robotically. Unfortunately after the transesophageal echo there was evidence of persistent left superior vena cava with a large diameter of the coronary sinus given these findings my heart surgeon decided to do the operation through the median sternotomy since according to him the ability to accomplish appropriate venous drainage was questionable. My question is whether percutaneous procedures would be appropriate for me should I require future Mitral Valve Repair or replacement? Dr Tuzcu can you please explain the reasons why a valve gets calcified?Dr Tuzcu I have had Mitral Valve Repair via median sternotomy 7.5 months ago what should be the highest heart after half an hour streneous exercise (dancing)? Dr Tuzcu after having had mitral valve repair (median sternotomy) 7.5 months should I worry if I get a simple cold (runny nose and sneezing) no fever or sore throat?

Speaker_-_Dr__Murat_Tuzcu: I will try to summarize your answers to your questions. Currently majority of the available information about mitral valve repair come from patients who did not have prior mitral valve surgery. Valves get calcified through a long process somewhat similar to atherosclerosis but it is still under investigation as to what is the exact mechanism. After you recover from open heart surgery it is most advisable for patients to undergo cardiac rehabilitation before engaging in strenuous exercise.

The risk of heart valve infection after common cold is not high at all. It does not require antibiotics unless prescribed by a doctor.

Seitz: I have been tested at four different hospitals, including Mayo, all of which give me vastly different assessments, taking the information from EKG's, echos, stress tests, etc. I do have mitral valve prolapse and need an operation, I don't have mitral valve prolapse, I do have minimal leakage but don't need an operation. I have a slight heart murmur, I don't have a heart murmur. Here is what I do have-with no symptoms-afib, which was gone but now has returned. A high hb of generally 150 most of the time. No symptoms. Only taking aspirin. 77 years old, non overweight, non drinker, non smoker, low pb, play tennis every day. Cannot tolerate toporolxl Now what?

Speaker_-_Dr__Murat_Tuzcu: It appears that you have intermittent problem of atrial fibrillation and a valve issue that is not serious enough for surgery. Two opinions of how to treat atrial fibrillation may differ - I would recommend you to talk with a cardiologist and share with him or her all the conflicting advice you have received in detail so they can be put in perspective.


Aortic Valve Disease

RoyW: I have been diagnosed with severe aortic stenosis. I am 40 years old and father of 4 young children I am a fairly successful general contractor that works every day and am very active with the kids and their activities. My surgeon and cardiologists feel that it is time to replace the valve. They will only do the valve by open heart surgery. I am concerned about the downtime and the life of a tissue valve and what happens in 15 to 20 years with hopes of outliving the valve expectancy.

Speaker_-_Dr__Murat_Tuzcu: There are multiple reasons why aortic valve becomes narrow. One of them is the progressive calcification of a congenitally abnormal valve. Your age group it is quite common to have this kind of aortic stenosis. We make the decision to proceed with surgery when patients develop symptoms such as shortness of breath, chest discomfort, fatigue, or fainting spells. Sometimes we refer patients to surgery even if they do not have any symptoms; but when they develop signs of weakness in the heart muscle.

When a patient is recommended surgery, based on these criteria, it is most appropriate to proceed with surgical treatment in a reasonably short timeframe because of the life saving nature of the surgery.

adourian: Would you expand on your comment about deciding on aortic valve replacement surgery with no symptoms but signs of weakness in the heart muscle. Does the echo show such a weakness and if I go to my echo report is there a measure of heart strength/weakness. If so what is it called and what is the level that is serious enough for surgery consideration?

Speaker_-_Dr__Murat_Tuzcu: Ejection fraction is a measure of how much of the blood in the left ventricle is ejected to the aorta with every heart beat. It should be over 55-60 percent. If from serial echocardiograms there is a trend toward lower ejection fraction that should raise a red flag. If your ejection fraction drops from 605 to 50% that requires a closer look to your condition.


Coronary Artery Disease

kates1128: My mother had two stents placed (one in LAD and one in LAD D1) last August in a complex bifurcation lesion. 6 months later she needed a new stent due to restenosis in the diagonal branch. Her first two stents were Taxxus Liberte and the third was a Cypher. She is on all the proper meds now, doing cardiac rehab, and feels okay, but still experiences a fair amount of sweating. She is doing a stress test next week to see if things are going okay. Our concern continues to be stent thrombosis and further complications due to the bifurcation lesion. How would you recommend treating such a patient? We are scared that having the doctor treat a bifurcation lesion with stents was a mistake. Would she have been better off being treated with medication only or would a bypass be safer route? Stent thrombosis is such a scary side effect and from what I've read her chances are increased because of the bifurcation?

Speaker_-_Dr__Murat_Tuzcu: Your mother would best be evaluated - we would be happy to evaluate her at the Cleveland Clinic or using our second opinion online service.

Speaker_-_Dr__Murat_Tuzcu: I see there are many questions left - unfortunately but I believe I have addressed the questions in other answers. We would be happy to evaluate you for your individual valve problems either through a visit or our online second opinion service.

Cleveland_Clinic_Host: Thank you again Dr. Tuzcu we appreciate it. Hopefully you can do this with us again soon!

Speaker_-_Dr__Murat_Tuzcu: I would love to come back again. Thank you for having me.

Technology for web chats paid in part by an educational grant from AT&T Ohio and the AT&T Foundation (formerly SBC).

Reviewed: 04/10


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