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Percutaneous Innovations for Treatment of Heart Disease - December 6, 2007

E. Murat Tuzcu, M.D.
Cleveland Clinic Heart and Vascular Institute Surgeon
Cleveland Clinic Department of Thoracic and Cardiovascular Surgery

Cleveland_Clinic_Host: Welcome Dr. Tuzcu, and thank you for joining us today. Let's begin with one of the questions!

Speaker_-_Murat_Tuzcu_M_D_: Thank you for having me.

Non-surgical Percutaneous Options for Heart Valve Disease

karen: I have a history of breast cancer with severe radiation damage to my chest and my heart valve. My doctor said my surgery would be difficult. Are there other options such as catheter procedures I could look into

Speaker_-_Murat_Tuzcu_M_D_: Yes. In patient with aortic valve narrowing, and symptoms such as severe shortness of breath, replacement of the diseased valve with a prosthetic valve relieves symptoms and prolongs life. It is true that the previous chest radiation makes surgery more difficult, but many times it is not impossible. But those patients who require a second heart surgery, after radiation the risk may be too high. For patients that have high risk of complications we are working on placing the prosthetic valve with the help of a catheter inserted from the leg. This is a technique that is being investigated in clinical trials at this time.

Speaker_-_Murat_Tuzcu_M_D_: Another investigation is focused on the delivering the valve again with the help of a catheter (a tiny tube) through a 2 inch incision under the left nipple (chest) while the heart is beating. At this time, these are investigational procedures but are promising yet waiting to be approved.

happydays: Will the percutaneous heart valve ever be part of normal treatment?

Speaker_-_Murat_Tuzcu_M_D_: Percutaneous aortic valve placement is very promising. Initial studies have demonstrated that one does not need to remove the diseased valve in order to place a new prosthetic valve.

Speaker_-_Murat_Tuzcu_M_D_: These valves can be delivered with the help of stents. At least in the midterm, the percutaneously placed valves seem to be durable and maintain their excellent function. With the advance of technology, it is not inconceivable that within the three to five year frame, percutaneous aortic valve replacement will be in our clinical tool box.

Speaker_-_Murat_Tuzcu_M_D_: Another valve replacement is already attracting a lot of clinical interest. The patients who have been previously operated once or more for a congenital heart defect benefit from percutaneous pulmonary valve replacements. Although there are efforts focused on developing percutaneous mitral valve replacement techniques, these are still in the design stage. The percutaneous mitral valve repair using clip has a good chance of clinical applicability in selected patients.

kathyb: Do you have any information about the studies for percutaneous heart valves? Do they last?

Speaker_-_Murat_Tuzcu_M_D_: The first percutaneous aortic valve was placed in France in 2002. We have very limited number of patients that were followed more than 2 to 3 years. These observations were published by Dr. Cribier. Recently Dr. Webb, from Canada, published his observations in his first 50 patients who received percutaneous aortic valve after one year follow-up. These two observations demonstrate that at least in the midterm, the valves are functioning well and do not show any sign of deformation or deterioration.

Mitral Valve Surgery - Non-surgical options

jameswinne: Can mitral regurgitation be fixed using the new techniques on a patient who has had bi-pass surgery?

Speaker_-_Murat_Tuzcu_M_D_: Investigations that focus on various mitral valve repair technologies include patients who had prior heart surgery. Thus, there is no reason to think prior bypass surgery will be a contraindication if and when these techniques become clinically available.

snewton: I saw a picture of the percutaneous mitral valve valve procedure on the internet. It looks like the two sides of the valves are closed together. Doesn’t the clip in the center of the valve cause less blood to flow through the valve? Does that cause more problems later?

Speaker_-_Murat_Tuzcu_M_D_: This technique called edge-to-edge repair was first performed surgically. Since then many surgical and percutaneous edge to edge repairs have been done and this question of narrowing was investigated. In great majority of cases, the double opening created by this type of repair does not result in narrowing or obstacle to the blood flow at all.

Speaker_-_Murat_Tuzcu_M_D_: Upon till today, with the exception of a few patients, edge-to-edge repair appears to be safe.

jon: My mother is 80 years old and has symptoms with mitral valve regurgitation. She has undergone a Heart Cath and an echo. She is weak and has some shortness of breath. Her cardiologist said she has a poor heart function and that surgery would be high risk. Are there non-surgical options?

Speaker_-_Murat_Tuzcu_M_D_: In patients with weak heart function and mitral regurgitation, the first question that should be answered is if the mitral valve is structurally abnormal or not. If it is abnormal, then the next question is the surgical repair of the valve feasible with an acceptable risk.

Speaker_-_Murat_Tuzcu_M_D_: If there is nothing wrong with the mitral valve itself, but the regurgitation is due to dilation and weakness of the pumping chamber of the heart (left ventricle), then the benefit that is expected from surgical treatment is much less certain.

Speaker_-_Murat_Tuzcu_M_D_: There are investigations going on to see if catheter based therapies will be as helpful as surgery. The most advanced of these techniques is attaching the midportions of the two leaflets of the mitral valve with a tiny clip.

Speaker_-_Murat_Tuzcu_M_D_: There is an ongoing randomized trial. In the context of the study, there is possibility to apply this technique in some patients that are not candidates for surgery.

Speaker_-_Murat_Tuzcu_M_D_: A lot of work is going on in trying to reshape the annulus of the mitral valve that is narrowing the frame, where the leaflets are attached by putting devices into the blood vessel adjacent to this frame (coronary sinus). The results of these investigations are pending.

jayhawkmary: I have mitral valve stenosis and am considering balloon valvuloplasty at the Cleveland Clinic. Is this procedure done as day surgery or does it require a hospital stay? Also, are there potential risks involved with this procedure, such as tearing of the valve, and if so what would be done by whom?

Speaker_-_Murat_Tuzcu_M_D_: Balloon mitral valvotomy has a history of more than two decades. In appropriately selected patients, it is the treatment of choice. Overall risk of mortality and serious complications is less than two percent.

Speaker_-_Murat_Tuzcu_M_D_: There is a risk of damaging the valve to a point that would require replacement of the mitral valve through open heart surgery. Although 4 out of 100 patients that undergo balloon procedure may require mitral valve replacement within days to weeks after the procedure, maybe 1 percent of them require this procedure to be done emergently. The Cleveland Clinic is a center with capabilities to address all these complications should they occur.

Speaker_-_Murat_Tuzcu_M_D_: Balloon mitral valvotomy requires an overnight stay.

jameswinne: What were the results of the everest studies?

Speaker_-_Murat_Tuzcu_M_D_: The feasibility study of the edge-to-edge repair of the mitral valve by the Clip demonstrated that the procedure can be carried out with a very high degree of safety.

Speaker_-_Murat_Tuzcu_M_D_: Even in patients that subsequently required surgery - even after months - clip placement does not limit patients chances for a mitral valve repair.

Speaker_-_Murat_Tuzcu_M_D_: In more than half of the patients that were enrolled in the study, a significant reduction in mitral regurgitation was obtained and maintained over a three year period.

Speaker_-_Murat_Tuzcu_M_D_: Currently, a randomized trial is underway. In this study patients are randomized to mitral valve replacement/repair by open heart surgery or to mitral clip.

Aortic Valve Surgery - Percutaneous Non-surgical Options

carln: Someone told me I should look at the PARTNER study for aortic valve replacement. Can you give me some information about that study and is the Cleveland Clinic the only center using it? I am 48 years old in need of an aortic valve in the near future.

Speaker_-_Murat_Tuzcu_M_D_: PARTNER study is comprised of two cohorts. In the first cohort, patients who are at very high risk of dying should they undergo standard aortic valve replacement through open heart surgery are enrolled. Patients who have an estimated mortality of 50 percent or greater are randomly allocated to undergo open heart surgery or catheter based aortic valve placement.

Speaker_-_Murat_Tuzcu_M_D_: The second cohort consists of patients who are deemed to be inoperable, that is their risk of dying or having severe complications, is prohibitively high. These patients are randomized to catheter based valve replacement versus standard medical therapy.

Speaker_-_Murat_Tuzcu_M_D_: In both groups only the patients that are symptomatic, are enrolled.

bobby: My father is 85 years old and has a diagnosis of atrial stenosis. He has no symptoms but his cardiologist said that valve surgery is very risky with a person his age. He is very active. When do you know someone needs valve surgery? Is this when a percutaneous valve would be a good option?

Speaker_-_Murat_Tuzcu_M_D_: I think you mean aortic stenosis - not atrial stenosis. We evaluate the patients carefully to assess if they have symptoms or not associated with aortic stenosis. Once a patient develops symptoms, then aortic valve replacement would be indicated. Age alone is not a reason to deny a patient surgery. WE have operated on many patients who are in their 80s and 90s - even a few who are over 100. However in patients who are elderly and has other medical conditions that put them at high risk for complications the percutaneous valve techniques that are under investigation are very promising.

nystrom: My father is 90 and has aortic stenosis. His doctor recommended a valve replacement with a biologic valve. He is very active still-but his doctor feels he needs the surgery. I am worried about the heart lung machine and anesthesia. Would there be other non-surgical options? He is not having symptoms but the doctor said he does need surgery.

Speaker_-_Murat_Tuzcu_M_D_: The issue of operating on a 90 year old in the absence of symptoms is a difficult one. Sometimes patients may not realize the limitations imposed by the aortic stenosis. Physicians should carefully go over a patients history and at times we need to perform a stress test to assess the exercise capacity of the patient and if the patient is truly symptomatic or not. Again age alone is not a contraindication for surgical treatment. If it is decided that a patient needs Aortic valve replacement, a center that has experience with high risk heart surgery particularly if they are also involved in the clinical trials of percutaneous aortic valve replacement.

Patent Foramen Ovale: PFO - Percutaneous Procedures

costela: Is a percutaneous procedure ever performed as a preventive procedure to reduce the risk of stroke in patients with a PFO?

Speaker_-_Murat_Tuzcu_M_D_: No. When one considers more than one fourth of the population as patent foramen ovale, but only a very small percentage of these patients will have strokes. It becomes apparent that the preventive PFO closure is not a feasible option. More over, there is not a consensus about advisability of PFO closure in patients who sustained a stroke. Experts differ widely on this very topic.

Speaker_-_Murat_Tuzcu_M_D_: It is important to mention that lack of consensus and lack of strong data indicating the benefits of PFO closure are the underlying reasons why there is no FDA approved PFO closure device at this time.

john: I have a P.F.O. My medical chart says the hole is "large". Can you tell me about the size of the holes and when you decide to close a PFO? Thank you.

Speaker_-_Murat_Tuzcu_M_D_: It is important to point out PFO is not a hole. It is not a defect. It is a slit like opening between the two chambers. Almost always the blood flow through this opening is very small compared to the blood flow (shunt) that occurs through an actual hole (ASD). Moreover the flow through a PFO is transient. Having said that, relatively large amount of flow and opening of the slit in the setting of a redundant mobile septum are thought to be risk factors for recurrent strokes in patients with PFO.

Speaker_-_Murat_Tuzcu_M_D_: After evaluation of the patient, by a stroke neurologist and experienced interventional cardiologist, many patients with 1 stroke and PFO are offered enrollment in a randomized trial that is designed to answer the question if PFO closure is equal or better than the medical treatment in order to reduce the risk of recurrent stroke.

Speaker_-_Murat_Tuzcu_M_D_: There are occasional patients that the neurologist and the cardiologist may decide to close the PFO. These are patients that are thought to be at particularly high risk or those who have recurrent strokes despite therapy.

snewton: Do you have to have antibiotics before dentist appointments if you had a PFO closed last year?

Speaker_-_Murat_Tuzcu_M_D_: It it has been a year, it is thought that the device is covered by the tissue already and thus antibiotic treatment may not be absolutely necessary but the decision should be made by the physician of the patient.

kyled: Would a cardiac catheterization show a PFO that is open?

Speaker_-_Murat_Tuzcu_M_D_: Before a cardiac catheterization is performed, diagnosis of PFO can be made by an echocardiogram. If a regular echocardiogram is not adequate than a transesophageal echocardiogram (TEE) can give more provide more detailed pictures. There is another test called transcranial Doppler that also help in diagnose PFO and other shunts.

Speaker_-_Murat_Tuzcu_M_D_: It is very infrequent to perform a catheterization for the diagnosis of PFO because of the availability of the above stated noninvasive tests.

suzie_b: I have a friend who is 30 years old. Recently she had a stroke. I read on the internet about stroke and Pfo and also migraines. I think she has headaches – I don’t know if those are migraines. How do you diagnose a PFO. Could this be a reason?

Speaker_-_Murat_Tuzcu_M_D_: As we saw more and more patients who had a PFO closure because of stroke, we made the observation that a number of these patients are either free of their previously bothersome migraine headaches or suffering much less intensely or frequently.

Speaker_-_Murat_Tuzcu_M_D_: There is at least one study that suggests the frequency and intensity of the migraines can be reduced by closing the PFOs. Currently there are several investigations on their way that aim to answer this specific question.

Speaker_-_Murat_Tuzcu_M_D_: A patient with a stroke and headaches should be evaluated by a neurologist to see if she or he is a candidate for a randomized trial - either from the point of stroke or migraine.

ronb: I am thinking of endoscopic treatment of a PFO. What is that? Is that better than surgery?

Speaker_-_Murat_Tuzcu_M_D_: Today we can close PFO using tiny tubes called catheters that are inserted from the leg artery in the groin. These procedures can be done with very high success rates and with very low risk of complications. Even though surgery can be performed with equal safety, it is much more invasive, requires 4 - 5 day hospital stay instead of 1 day and requires 4 - 8 weeks recuperation instead of a couple days.

Speaker_-_Murat_Tuzcu_M_D_: Thus, for most patients, if there is a need for PFO closure, catheter based technique rather than surgery is preferred.

steven: I am allergic to nickel - can I still have a closure device? What are my options?

Speaker_-_Murat_Tuzcu_M_D_: Widely used closure devices (Amplatzer from AGA and CardioSeal from NMT) include nickel in their alloys. Although there are rare reports in the literature that nickel allergic patients may develop complications, there is no strong data that would make us recommend not to use these devices. There are investigators that think that people who have nickel allergy may develop headache and palpitations, but most of these symptoms are temporary and resolve within a year. In summary, having a nickel allergy is not a contraindication for catheter based closure.

Aortic Aneurysm - Percutaneous Procedures

RCoren: Can percutaneous techniques be used for an aortic aneurysm ?

Speaker_-_Murat_Tuzcu_M_D_: Endoluminal treatment of abdominal and thoracic aortic aneurysms are in clinical use. Stent grafting is widely available. There are centers with the expertise of stent grafting even more complex thoracic aneurysms with the involvement of the branch vessels. The repair of the ascending aortic aneurysms with a catheter based technique are still under investigation.

RCoren: Re: your previous answer; i have an ascending aorta aneurysm and have already had two CABG and an aortic valve replacement. this makes another open chest job rather risky.

Speaker_-_Murat_Tuzcu_M_D_: The risk is a relative concept. The risk of another operation is certainly not prohibitive unless there are additional serious medical illnesses. You should be evaluated in an experienced center that has the experience in repeat operations as well as clinical trials involving stent graft.

Coronary Artery Disease – Interventional Procedures

sam_i_am: I live in Missouri. I have a blockage in my left main trunk. I think I need a percutaneous interventional procedure. Is that a difficult procedure? How do I come to the Cleveland Clinic for that?

Speaker_-_Murat_Tuzcu_M_D_: The severe left main coronary artery narrowing is an important clinical problem. Many patients with this problem are referred for bypass surgery. Over the last five years, stenting techniques have been developed a well. Currently, there is very limited comparative data available. Success of the stenting depends on the location of the narrowing, involvement of the other arteries. Success of surgery depends on some other variables. It is best for the patient to be evaluated where there is expertise of both specialties available. We would be happy to help you at the Cleveland Clinic, just contact us through our website.

Cleveland_Clinic_Host: I'm sorry to say that our time with Dr. Tuzcu is over. Dr. Tuzcu, thank you again for taking the time to answer our questions today.

Speaker_-_Murat_Tuzcu_M_D_: I enjoyed this format. Thank you for having me today.


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