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Percutaneous Valve Treatments (Drs. Tuzcu, Kapadia and Svensson 9/28/10)

Tuesday, September 28, 2010 - Noon
Murat Tuzcu, MD

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

Samir Kapadia, MD

Samir Kapadia, MD
Director of the Sones Cardiac Catheterization Laboratories and Director of the Interventional Cardiology Fellowship Program in the Robert and Suzanne Tomsich Department of Cardiovascular Medicine.

Lars Svensson, MD

Lars Svensson, MD
Attending surgeon and Director of the Aorta Center, Director of the Aorta Center, specializing in the treatment of Marfan Syndrome and Connective Tissue Disorders, and Director of Quality and Process Improvement in the Department of Thoracic and Cardiovascular Surgery at Cleveland Clinic.

Description

Traditionally, when the heart’s valves become severely damaged (become regurgitant or stenotic), heart surgery is used to repair or replace the valve and restore the heart’s normal function. Most patients are able to undergo surgery without difficulty. However, for people whose heart function is too severely compromised to withstand surgery, catheter-based percutaneous procedures (usually requiring only one or more small puncture sites through the skin) can provide excellent results. There are multiple percutaneous valve treatment options currently available and exciting new developments on the horizon. Drs. Murat Tuzcu and Samir Kapadia, Interventional Cardiologists and Dr. Lars Svensson, Cardiothoracic Surgeon at Cleveland Clinic discuss Percutaneous options.

More Information

Cleveland_Clinic_Host: Welcome to our online health chat with doctors Murat Tuzcu MD, Lars Svensson MD PhD, and Samir Kapadia MD. They will be answering a variety of question on "Percutaneous Valve Treatments".


The PARTNER Trial Cohort B results and Clinical Trials

Cleveland_Clinic_Host: The PARTNER trial cohort B results were published in NEJM last week. What were the major results?

Dr__Kapadia: As you may know the PARTNER trial cohort B compared outcomes for patients undergoing percutaneous aortic valve replacement to those managed with best available therapy in patients who were deemed inoperable.

The transcatheter aortic valve implantation (TAVI) saved 1 life for every 5 treated and saved 1 life and hospitalization for every 3 patients treated.

Patients who did not have valve replacement had 50% mortality at one year.

Dr__Svensson: At 2 years after the procedure patients who had the new percutaneous valve had a 67% better survival than the patients who did not get the new valve.

Fred: Since the results that were published last week look so promising, when do you anticipate final approval by the FDA?

Dr__Svensson: The approval of the valve will be up to FDA.

thomas: is there a new partner trial know or when hart

Dr__Tuzcu: There will be future trials investigating the value of this and evolving technologies in different patient populations.

anthony: are the trials still going on for the percutaneous valves? what are the inclusion and exclusion criteria?

Dr__Svensson: The two US trials are being completed but we are allowed to continue to enroll patients. However, for the inoperable high risk patients we expect that by the end of the year a new trial will start with a smaller catheter and new valve.

Currently the entry criteria for inoperable patients are that patients are deemed inoperable by 2 surgeons and the patient has aortic valve stenosis with a valve area less than 0.8 and a mean pressure gradient above 40 mm.

Dr__Kapadia: The definition of inoperable was that the risk of irreversible morbidity and mortality was estimated to be more than 50% - in other words, the operation would create more harm than help.

Dr__Svensson: For the high risk surgical patients, patients have to have a calculated STS risk of death exceeding 10 percent and also a valve area less than 0.8 square cm and a pressure gradient more than 40 mm Hg.

marianne: can you tell me what you envision as the future of these valves? who will they be used for? will they be used for young first time valve patients?

Dr__Tuzcu: When one looks at the experience with angioplasty and stenting, it is reasonable to expect that the transcatheter valves in the future will be applied to a significant proportion of patients with aortic stenosis (AS).

Having said that, surgery for AS has been perfected over a half of century and can be performed in young patients with no other serious illness with extraordinary safety and long term durability.

The transcatheter valves should provide equally good results before they are considered for young or low risk patients.

Dr__Kapadia: With smaller valves, the risk of vascular complications which was 16% in the PARTNER trial will be lower and we still need to lower the risk of major stroke (which was 5%) and perivalvular leak (about 10%).

thomas: Now that this part of the trial is over, is it still part of a research study or how do you get evaluated for this type of treatment?

Dr__Tuzcu: Still part of the research study - Under the guidance and supervision of the FDA.

Dixie: Did any of the Percutaneous aortic valve recipients experience symptoms similar to post perfusion syndrome? What were the types of complications of the procedure? What were the causes of mortality in the 30.7% of the recipients that did not survive the one year? (figure from Wallstreet Journal Article)

Dr__Kapadia: Major stroke rate was 5 percent, vascular complications were 16% and procedural (30 days) death was 6.4%. The most common cause of mortality was still cardiovascular in etiology.

Dr__Svensson: In the detailed analysis of causes of death in the trial that I presented on Friday morning, patients that received the percutaneous valve had a much higher risk of death from other causes (non-cardiovascular causes) because they survived longer and so they died from the comorbid diseases.


Percutaneous Aortic Valve – also called Transcatheter Aortic Valve Implantation (TAVI)

Fred: Is this procedure covered by medicare?

Dr__Tuzcu: Yes - it is covered as long as it is being used in the context of the investigation.

charla10: My 80 year old aunt has AS and partly I wonder if she is a candidate for the procedure and secondly I read in one article that the outcomes for those who had nothing done were in really bad shape. I am worried for her. If she is not a candidate for surgery or this procedure, then what should we do? If she is a candidate for this procedure, what is the waiting period?

Dr__Tuzcu: It is true that patients with aortic stenosis due poorly particularly after they start to have symptoms or if their heart function weakens. We would be happy to evaluate her to see if she is a candidate for surgical aortic valve replacement and if not to see if she can be enrolled in the PARTNER trial.

Dr__Svensson: If she has no comorbid disease and is otherwise healthy I would quote her a 2% risk of death with a minimally invasive keyhole surgery.

barbie13: My father who is 88 yrs has been diagnosed with Aortic Stenosis. He is very short of breath and has a lot of fatigue. Because of his age, the doctor doesn't recommend surgery for him - what do you think of this valve for him?

Dr__Svensson: We would recommend he be evaluated for percutaneous valve.

Dr__Kapadia: Average age in the PARTNER trial was 84 years and 20% of the patients were over 90.

rickj: My dad had a prior aortic valve aneurysm that was repaired in the thoracic area. Would he be a candidate for this percutaneous valve procedure?

Dr__Svensson: He needs to be evaluated since it is not clear what his situation is.

sara_j25: I read online that there was also a risk of stroke with the percutaneous valve. Are there things you can look at before surgery to see who is at risk for this - or did it not matter based on risk? It seems as though at this time surgery is best if you can make it through surgery? Is that what you think?

Dr__Tuzcu: The risk of stroke whether if it be after surgery or percutaneous valve in part depends on characteristics such as atherosclerosis in the aorta and in the blood vessel going to the brain. Patients are evaluated for these preoperatively. The PARTNER trial clearly demonstrated in patients that are not candidates for surgery benefit from percutaneous valve tremendously. We have to wait the results for the second part of the PARTNER trial to see how percutaneous valves performed in comparison to high risk surgery.

jeffersonkp: My mom had bypass surgery 10 years ago and has a pacemaker. She now has AS and is worried that a traditional surgery would damage the pacemaker and/or bypass grafts that she has. Would a transcatheter valve be an option for her?

Dr__Svensson: Reoperation does not interfere with the previous pacemaker surgery unless the tricuspid valve also needs to be repaired but this is usually not a problem. As far as damage to the previous bypasses, the risk is very low and if your mother is younger than 80 with no other comorbid disease this is the preferred operation.

If she has significant comorbid disease and is older than 80, then it would be worthwhile to have her evaluated for a potential percutaneous valve.

genodoc: How soon before most aortic valve replacements will be percutaneous?

Dr__Svensson: We do not know the answer to that question.

Dr__Tuzcu: It will not be in the next few years.

genodoc: how long before transcutaneous replaces open chest surgery

Dr__Kapadia: As we stated before, we would like it sooner but we do not know.

mbt13: I will be visiting your facility at the end of this week for lab work and tests related to my aortic & mitral valve. Due to the severe calcification in my aorta, my surgeon feels the risk is very high if the aorta needs clamped yet it seems like I need to replace the valve. I understand that Cleveland Clinic has a technique to replace the aortic valve without the need to clamp the aorta. My appointment is on 9/30/10 and I would love as much information about this procedure as possible prior to my visit this week. Thank you for your forthcoming response.

Dr__Tuzcu: First go to the website at www.clevelandclinic.org/heart to learn more about percutaneous options. Ask your doctor when you come to the Cleveland Clinic all the information about this procedure.

mbt13: Please explain the difference related to hospital stay duration and post op pain between open heart valve replacement and percutaneous.

Dr__Tuzcu: You can be discharged from the hospital as early as 2 days after transcatheter valve implantation via femoral route. Usually takes 5 days or more of hospital stay after open heart surgery. Because most of the time, there is no incision in percutaneous implantation via femoral artery, the pain is usually not a major issue.

Comparison will be available after the second part of the PARTNER trial is published.

mbt13: I am 70 with aortic valve stenosis and leaky mitral. My aorta is severely calcified therefore it has been determined that traditional clamping is at very high risk. Would I be a good candidate for percutaneous procedure?

Dr__Svensson: We would require evaluation of your situation to see whether you would be a candidate for the percutaneous valve procedure. However, most patients with aortic valve stenosis and a calcified aorta can be treated with reasonable results. The mitral valve would be repaired at the same time.

mbt13: Is the percutaneous method a tissue or mechanical valve or both?

Dr__Kapadia: It is a tissue valve.

Dr__Svensson: It is a wire mesh cylinder with a biological valve leaflets.


Valve Reoperation and transcatheter aortic valve implantation (TAVI)

Tien: Hello, I'm trying to find out about Transcatheter valve-in-valve procedure for my father. He has a leaking aortic valve and needs to have a surgery to replace the valve. He is very hesitant to do the open heart surgery. Is this procedure available at the Cleveland Clinic? He is 69 years old. Is it possible to find out how much the procedure costs? Thank you for your help, Tien

Dr__Svensson: At this time valve in valve is not available in the United States. However, your father would on average have a 2 - 3% risk of death with an open operation if he has no other major co-morbid disease based on our results.

Currently, the risk of percutaneous valves exceeds the risk of open reoperation for this age group.

Dr__Kapadia: In the United States the current experience is in patients who have narrowed (stenotic valve) - the leaky valve experience for TAVI is limited in the whole world.

frank: Do you foresee a time when patients who have had valve replacement surgery would be a candidate for this procedure?

Dr__Tuzcu: There is limited experience treating the malfunctioning aortic valve prosthesis and mitral valve prosthesis with catheter based technologies. But - this experience is limited to patients who are at very high risk for operation.

This limited experience is promising but in lower risk patients the risk of operation is low in experienced centers such as Cleveland Clinic.

Dr__Svensson: Here at the Cleveland Clinic it is only patients after the age of 80 that the risk of reoperation for previous aortic valves increases to 5.6%. Below the age of 70, it is 2.3%.

troy: percutaneous valve replacement- could possibly replace valve within a valve?

Dr__Kapadia: As Dr. Tuzcu already suggested there is some experience putting valve in valve and it is promising.


Aortic Valve Regurgitation (Leak)

kent1954: I have an aortic leakage; I am 56 in good health except for 20 lbs. overweight. On a scale of 1-4 I am at 2 1/2. Is waiting till I get worse dangerous? If not how often should tests be given to find out if I am getting worse

Dr__Kapadia: Waiting is not dangerous as long as you are asymptomatic and your heart is not getting dilated or tired. Periodic checking of the heart with echocardiography or stress echocardiography is the current recommendation.


Tricuspid Valve Disease

Ann: My son has tricuspid valve disease - I have heard there may be non invasive or percutaneous options for this valve. Is that true? Or do you see this in the future?

Dr__Kapadia: Currently this not an option. Although many new devices are being developed for this purpose as we have summarized it in one of the recent publications in "Circulation Intervention."

Cleveland_Clinic_Host: Those were all the questions we received for the chat today.

Dr__Tuzcu: Thank you for this opportunity to chat today.

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


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.


Reviewed: 10/12

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