Breakthrough Medicine
EPISODE 1 — Mending Broken Hearts: Percutaneous Aortic Valve Replacement
In the premier episode of Breakthrough Medicine, we watch as UHealth physicians work to save the life of a man suffering with aortic stenosis using an experimental treatment performed as part of a clinical trial available in Florida only at University of Miami Hospital. To view the episode, click the box above.
Aortic stenosis, a life-threatening condition, is an abnormal narrowing of the aortic valve that restricts blood flow from the heart to the organs and tissue. The percutaneous aortic valve replacement clinical trial – available in Florida only at University of Miami Hospital – uses experimental procedure to treat aortic stenosis in patients who are not eligible for open-heart surgery. You can read more about the trial in the Summer 2008 issue of University of Miami Medicine, or visit our Frequently Asked Questions page.
We also invite you to learn more about Dr. William O’Neill and Dr. Alan Heldman, two of the UHealth physicians who were featured in the episode.
If you are interested in other clinical trials taking place at UHealth, please click here.
Web Chat Transcripts
| justnews.com(P) | Thank you for joining UHealth's Breakthrough Medicine Web Chat. The discussion will begin at 8:30p.m. EST on Tuesday, April 28th. In the meantime, you can learn more about UHealth by calling 305-243-4000 or by visiting www.uhealthsystem.com . We look forward to speaking with you soon. | |
| goldie(Q) | just watched your show on tv. Im concerned. Im 38 , female and healthy and the doctor recently told me i have a leaky valve and i shouldnt do anything about it. what do u say. | |
| Dr_Alan_Heldman(A) | Thanks for your question -- depending on which valve, and how leaky, and other factors, it is possible that valve "regurgitation" (leaking) can be quite benign -- or can be very serious. One important thing is whether or not one has symptoms like shortness of breath or swelling. A cardiologist should be able to give you some guidance, maybe some medication, and follow you to see if you'll ever need anything done about it. | |
| Dennis(Q) | I am a 60yr old male who had open heart surgery in 2006 to replace my calcified aortic valve with a porcine one. My cardiologist had advised me that I may need to replace it within 10-15 yrs. First, i would like to know if the projection for approval by the FDA is good; also, I presently take Plavix, but since the new valve that you implant is mechanical, would I need to take Coumadin for the rest of my life? Thank you. | |
| Dr_William_ONeill(A) | Dennis, You will be eligible for this procedure when you need it. The current valve you have will be good for a few years., when you need it replaced, it can be done with this new procedure.you do not need coumadin because this is a tissue valve. | |
| Mark(Q) | I had my aortic valve replaced by Dr. Donald Williams on July 14, 2004. It is probable that by the time I need to replace my porcine valve, the procedure will be minially invasive. | |
| Dr_Alan_Heldman(A) | Thanks for this note. Right now the clinical trial is looking at the new valve only for treating "native" (not artificial) aortic valves -- but you are quite right, that it may become possible to re-treat an artificial tissue valve by implanting a new valve inside it, using the non-surgical technique. | |
| Mike(Q) | How are the patients selected? For those who are randomized and do not get selected, what happens to them? | |
| Dr_William_ONeill(A) | ELIGIBILITY Patients with severe aortic stenosis who are high risk or who are not candidates for conventional open-heart surgery may qualify to participate in this study. Once a patient meets this criterion, further screening is conducted to determine eligibility. In a randomized trial, patients will find out only after they have first been enrolled in the trial and then randomized if they will receive the transcatheter valve or not. This process is performed at random by a computer. There is no minimum or maximum age eligibility for the study, and we do accept out of state patients. To learn more about the aortic valve replacement clinical trial being conducted at University of Miami Hospital, visit www.uhealthsystem.com or call 305-243-4000. for those that get randomized to control, they are treated as they normally would have been. | |
| Michael(Q) | What is the relationship between congrestive heart failure and the heart valve stenosis that Mr. Koppelman experienced? | |
| Dr_Alan_Heldman(A) | Aortic valve stenosis can cause the left ventricle of the heart to fail -- it can't pump blood adequately. When aortic valve stenosis causes heart failure, the prognosis is very serious -- without valve replacement, most patients will not survive 2 years. | |
| Sharon(Q) | Patient is 95 - female - no serious other problems - is she a possible candidate for procedure - diagnosed with aortic valve calcification? | |
| Dr_William_ONeill(A) | yes there is no age limit as long as her quality of life is good otherwise. | |
| Mark_Supina(Q) | How does som?one get aortic stenosis? | |
| Dr_Alan_Heldman(A) | Great question. There are a few ways. Aging is the most common risk factor, and by the 80s or 90s a significant fraction of people will have AS. Having an abnormal valve from birth can make this occur earlier in life, as can rheumatic fever. | |
| Lewis(Q) | How many of the procedures have been performed at UM? | |
| jnadmin(A) | There are currently 31 patients enrolled in the study. | |
| goldie(Q) | thank you . i dont have shortness of breath but i do have a hard time getting a deep breath through sometimes. | |
| Dr_Alan_Heldman(A) | So you should be seen by a cardiologist, who will probably do an echocardiogram (ultrasound test) which gives us a great understanding of the valves and heart function. Good luck! | |
| jb(Q) | are there any other non-invasive trials going on re; valve replacement? | |
| Dr_Alan_Heldman(A) | Right now, this is the only US trial for aortic valve replacement. There are some early stage trials looking at nonsurgical ways to treat a leaky mitral valve too. | |
| Richard(Q) | can that new procedure be put in any part of the heart, or does it have to be on that particular aortic valve? Can you explain more into detail how it works? | |
| Dr_William_ONeill(A) | currently we are only treating the aortic valve.How does the procedure work? The Edwards SAPIEN transcatheter heart valve, which is an investigational device, is mounted and crimped onto a balloon delivery catheter to the approximate diameter of a pencil and threaded either through the patient’s circulatory system from the femoral artery in the leg to the patient’s diseased valve – all without cardiopulmonary bypass, and on a beating heart. for more information please go to www.uhealthsystem.com | |
| jjg(Q) | Is there a minimum age for someone to qualify for this new vavle surgery? | |
| jnadmin(A) | Patients must be at least 18 years old to participate in the study. | |
| marty(Q) | I would like to know how i can find out if I am a candidate for this procedure, I am 63 years old & had a triple by pass and have had a defibrilator/pacemaker installed | |
| Dr_Alan_Heldman(A) | A medical examination is the best way to determine your eligibility for the clinical trial. If you have been diagnosed with aortic stenosis, or feel you may be a candidate for this study, please call 305-243-4000. We would be glad to see you! Patients with severe aortic stenosis who are high risk or who are not candidates for conventional open-heart surgery. Once a patient meets this criterion, further screening is conducted to determine eligibility to enter into this randomized clinical study. | |
| jjg(Q) | But is there a minimum age? In other words, can someone be too young to qualify for this surgery? | |
| jnadmin(A) | 18 is the minimum age for participation in the study. | |
| Lisa(Q) | One year ago my 59 year old sister had a aeorta valve replacement. I am 51 years old & was told to get check for the same genetic aeorta valve defect. Of course I to have this & was told I to? will need a valve replacement it 10 years. In the mean time they are suggesting beta blockers do you agree. Also I have some shallow breathing is this a complication of the aeorta valve???Thank you see you in 10 years. | |
| Dr_William_ONeill(A) | an echo test can tell you if you have aortic valve disease. as far as your other sysmptoms, you really need to be examined to give you more information. if you would like an appointment please call 305-243-4000 | |
| Michael(Q) | Thank you for your response. Full disablement from shortness of breath | |
| Dr_Alan_Heldman(A) | A medical examination is the best way to determine your eligibility for the clinical trial. If you have been diagnosed with aortic stenosis, or feel you may be a candidate for this study, please call 305-243-4000. | |
| HB(Q) | Awesome program, congratulations. My father is an open heart patient survivor has a tissue valve thats approx 10 years old. We were told that this type of valve lifes is approx 15 years would he potentially be a candidate for this proceedure? | |
| Dr_Alan_Heldman(A) | Thanks for this note. Right now the clinical trial is looking at the new valve only for treating "native" (not artificial) aortic valves -- but in the future it may become possible to re-treat an artificial tissue valve by implanting a new valve inside it, using the non-surgical technique. We are working on it! | |
| marty(Q) | how can you become part of the study | |
| Dr_Mauricio_Cohen(A) | Patients with severe aortic stenosis who are high risk or who are not candidates for conventional open-heart surgery may qualify to participate in this study. Once a patient meets this criterion, further screening is conducted to determine eligibility. In a randomized trial, patients will find out only after they have first been enrolled in the trial and then randomized if they will receive the transcatheter valve or not. This process is performed at random by a computer. There is no minimum or maximum age eligibility for the study, and we do accept out of state patients. To learn more about the aortic valve replacement clinical trial being conducted at University of Miami Hospital, visit www.uhealthsystem.com or call 305-243-4000 | |
| Adelana(Q) | The procedures shown on the TV tonight how was the done. I didnot seem to get it | |
| jnadmin(A) | For participants who are randomized into the group receiving the Edwards SAPIEN transcatheter heart valve, the valve is mounted and crimped onto a balloon delivery catheter to the approximate diameter of a pencil and threaded either through the patient’s circulatory system from the femoral artery in the leg to the patient’s diseased valve – all without cardiopulmonary bypass, and on a beating heart. | |
| sheila(Q) | If, in the future, he shows signs of having a heart problem, the nearest hospital would be NW Medical Center. Since time matters in a situation such as this, how long would it be before he could be transferred down to your hospital? Would it be smart to go down to your hospital, at once before going to the closest hospital? | |
| Dr_William_ONeill(A) | we have a dedicated ambulance and can transfer within an hour. if this ever happens you can call the University of Miami ER and ask to speak to the doctor on call./ | |
| carol(Q) | what is the su?cess rate of the trial to date and is it covered by Medicare if not FDA approved yet? | |
| Dr_Alan_Heldman(A) | Because this is an ongoing clinical trial, it is not possible yet to predict the results. In the clinical trial, patients and their insurers are billed for the aspects of their care that are clinically indicated, including (should they receive it), the valve implantation. Aspects of their care that are required only for the study (including some screening and some follow-up tests) are not charged to patients or their insurers and are covered by the study. | |
| michelle(Q) | I missed the beginiing of the program - was there e cause attributes to MR. Koppelman' valve stenosis | |
| Dr_William_ONeill(A) | this disease affects people over age 70. there are some genetic components and generallly it is considered an aging phenomenon. | |
| exomara(Q) | how does the opreation of aortic stenois work? | |
| jnadmin(A) | For participants who are randomized into the group receiving the Edwards SAPIEN transcatheter heart valve, the valve is mounted and crimped onto a balloon delivery catheter to the approximate diameter of a pencil and threaded either through the patient’s circulatory system from the femoral artery in the leg to the patient’s diseased valve – all without cardiopulmonary bypass, and on a beating heart. | |
| kathy(Q) | At what point of aortic stenosis do you consider surgery if you at not showing classic signs? My arortic stenosis is labeled moderate-severe-severe. | |
| Dr_Mauricio_Cohen(A) | Tipically we do not refer patients who are asymptomatic to surgery. However, in some instances patients start slowing down because they feel fatigued. Therefore in these cases we may request a stress test that has to be very carefully monitored. The objective is to assess the true functional capacity of the patient. If the capacity is low or the blood pressure does not increase appropriately, then the patient may be a candidate for valve replacement. In other cases, we follow the heart squeeze very closely every 6 months or so. If the heart squeeze starts to deteriorate, then it means that surgery is indicated. | |
| Randi(Q) | Hi, I am a 40-year old man in good health. But people have told me that I need a CT angiography b/c people my age sometimes have heart disease, but they don't know it until a heart attack. Do I need the test? | |
| Dr_Alan_Heldman(A) | Thanks for this interesting question. CT angiography is one way that we can assess your risk -- along with more basic testing like an examination, blood pressure, cholesterol, family history, etc. At University of Miami Hospital we use a 128 slice CT scanner that really does give us great views of the coronary arteries. | |
| carol(Q) | cardiologist has recommended it for me. how long is general recovery and hospital time? | |
| jnadmin(A) | While each patient may be different, we believe the typical hospital stay may be approximately 4 – 7 days. | |
| Mark_Supina(Q) | How can you prevent getting aortic stenosis? | |
| Dr_Mauricio_Cohen(A) | There is no such therapy at this moment. Some investigators around the country have hypothesized that statins (such as Zocor, Lipitor, Crestor, etc) may decrease the progression of aortic ste?osis. However, these results are very preliminary. | |
| jnj(Q) | Great program, what is the youngest known patient who has had this type of valave procedure? | |
| Dr_William_ONeill(A) | in the US, patients need to be older than 70. There is a pediatric version that has been used in kids in there teens with disease of the pulmonic valve. this is done at the university of chicago | |
| Richard(Q) | can that new procedure be put in any part of the heart, or does it have to be on that particular aortic valve? Can you explain more into detail how it works? | |
| Dr_Alan_Heldman(A) | The trial shown on this program was about a valve which is only for treating aortic valve stenosis. The Edwards SAPIEN transcatheter heart valve, which is an investigational device, is mounted and crimped onto a balloon delivery catheter to the approximate diameter of a pencil and threaded either through the patient’s circulatory system from the femoral artery in the leg to the patient’s diseased valve – all without cardiopulmonary bypass, and on a beating heart. | |
| joe(Q) | Is there a similar procedure for people with mitral valve failure? | |
| Dr_Mauricio_Cohen(A) | There is an experimental percutaneous procedure for selected patients with mitral valve leakage. The procedure consists in clipping the two leaflets together to reduce the leakage. There are multiple technologies that are currently being developed. | |
| michelle(Q) | is Prolapse Mitral Valve a form of valve stenosis? | |
| Dr_William_ONeill(A) | this condition is very common and usually does not cause any health risk. rarely when it is a severe case., the valve needs to be fixed. | |
| PK_in_Broward(Q) | Are there many patients waiting to have this procedure? | |
| Dr_William_ONeill(A) | Hi Patty! Its so great to see you were paying attention! | |
| NINA joined. | ||
| Murray left. | ||
| ROLINE(Q) | My dad is 66 years old he had open heart surgery in 1999 at Miami Heart. He has two ruptured valves his symptoms include shortness of breath and swelling in the feet. I think that he would be a candidate for this surgery. Please let me know! | |
| Dr_Alan_Heldman(A) | A medical examination is the best way to determine your dad's eligibility for the clinical trial. If you feel he may be a candidate for this study, please call 305-243-4000. We would be glad to see him. | |
| Charles joined. | ||
| DAN_OZARK(Q) | HOW CAN WE VIEW THE SHOW AGAIN? | |
| jnadmin(A) | The show will re-air on channel 10 Saturday, May 9 at 4:30 p.m. and Sunday, May 10 at 1:00 p.m. The episode will also be available for viewing online after April 29 by going to www.uhealthsystem.com. | |
| Pablo(Q) | What makes or keeks the valve working. | |
| Dr_Alan_Heldman(A) | Like the body's original valve, the leaflets are pliable flaps which can open to allow blood flow out of the heart, and then close to keep blood from going back into t?e heart. | |
| HB(C) | Thank you Keep up the good work! | |
| exomara(Q) | i've been treated for one of ur specialist but i have not been in their for the last three years, it my fault.im suffering from a rapid heartbeat lately.my question is:if i have aortic stenosis how can i get into your experimental program? i will be glad and willing to. | |
| Dr_William_ONeill(A) | To learn more about the aortic valve replacement clinical trial being conducted at University of Miami Hospital please call 305-243-4000 or visit www.uhealthsystem.com. Or, if you are interested in learning about another medical condition, you can visit University of Miami Health System’s Health library at www.uhealthsystem.com, or call 305-243-4000 for a referral. if you would like an appointment with one of our cardiologists, please call the same number and they can help you see someone. | |
| Joan(Q) | I am 55 yrs old I am hypertensive. I am having constant dizziness especially when I am in a crowd. This will also accure when I am hungry. I will like to know what is happening to my bidy and what can I do | |
| Dr_Alan_Heldman(A) | There are lots of things that can cause dizziness --- actually sometimes it's one of the harder symptoms to figure out. I suggest you start with a medical doctor, and if needed he/she might send you for other specialist consultation or for tests. Good luck! | |
| jjg(Q) | I have a friend, age 62, female, overweight, significant shortness of breath in need of valve replacement surgery. She is employed now with good health insurance but will lose her job in the next 6 months or so because her company is moving to Mexico. I believe her doctors think she needs to lose some weight to qualify for the invasive valve surgery, but she doesn't have enough time befoe she loses her job (she will not be able to afford COBRA). Could she qualify for this study? If so, who can she contact? My wife and I are very concerned for her life. Thank you. | |
| Dr_Mauricio_Cohen(A) | This is a complicated problem. What type of valvular problem are we talking about? If this is indeed aortic stenosis, we can look into it. She would need to be evaluated by a specialist. She can access the UHealth’s physician database at www.uhealthsystem.com, or call 305-243-4000 for a referral. Regarding cost, patients and their insurers are billed for the aspects of their care that are clinically indicated, including (should they receive it), the valve implantation. Aspects of their care that are required only for the study (including some screening and some follow-up tests) are not charged to patients or their insurers and are covered by the study. | |
| ChrisS(Q) | What can go wrong during this procedure? | |
| Dr_William_ONeill(A) | Risks may include bleeding from the groin artery, myocardial infarction (heart attack), renal failure, stroke and death. A complete list of risks is included in the consent form patients receive when they enroll in the study. | |
| Sue(Q) | Are insurance companies covering for this type of procedure, since it's a clinical trial? | |
| jnadmin(A) | Patients and their insurers are billed for the aspects of their care that are clinically indicated, including (should they receive it), the valve implantation. Aspects of their care that are required only for the study (including some screening and some follow-up tests) are no? charged to patients or their insurers and are covered by the study. | |
| jose(Q) | I was advised to have aortic valve replacement. I am 38 yrs can i be a candidate for the procedures | |
| Dr_Alan_Heldman(A) | For this trial, eligible patients are those with severe aortic stenosis who are high risk or who are not candidates for conventional open-heart surgery. Once a patient meets this criterion, further screening is conducted to determine eligibility to enter into this randomized clinical study. If you feel you may have aortic stenosis, but have not been diagnosed, or if you would like to learn more about the aortic valve replacement trial being conducted at University of Miami Hospital, contact UHealth – University of Miami Health System at 305-243-4000. | |
| jose(Q) | Dr William, is there an age limit? for this procedures | |
| jnadmin(A) | Patients must be at least 18 years old to participate in this study. | |
| Charles(Q) | Can this proceedure be used to repair a leakuing mitral valve | |
| Dr_Mauricio_Cohen(A) | No. This procedure is specifically indicated to repair the condition known as aortic stenosis. The aortic and mitral valves are very different and work under different pressure conditions. Therefore, each valve needs specifically designed technologies. | |
| Danny(Q) | My doctor doesn't work at your hospital. Is there any reason he can't do this procedure for me if I qualify? He's an excellent surgeon. How can he perform it for me? | |
| Dr_Alan_Heldman(A) | University of Miami Hospital is the only study center in Florida. The full list of trial sites and additional information about the study can be found at http://www.clinicaltrials.gov/ct/show/NCT00530894?order=4. | |
| liz_p(Q) | i'm very short of breath after taking few steps going up stairs, would i be at risk? | |
| Dr_William_ONeill(A) | i am very concerned about these symptoms, especially if they have worsened recently. you really need to see a doctor soon to have these symptoms evaluated. If you cannot sleep or are short of breath at rest, you should go to the nearest ER. | |
| Bob(Q) | Where can you get a copy of the show? | |
| jnadmin(A) | The show will also be available for viewing online tomorrow at www.uhealthsystem.com. For more information, please call UHealth at 305-243-4000. | |
| Pablo(Q) | Dr Heldman, so the blood flow is what pushes the valve open and then it closes by its self and then repeats. | |
| Dr_Alan_Heldman(A) | That's exactly right. The valve leaflets are opened by the blood flow, then when the heart relaxes, the valve falls closed and keeps blood from leaking back into the heart. | |
| BETTY(Q) | I MISSED THE SHOW TONIGHT. WHERE CAN I GO TO WATCH IT? | |
| jnadmin(A) | The show will re-air on channel 10 Saturday, May 9 at 4:30 p.m. and Sunday, May 10 at 1:00 p.m. The episode will also be available for viewing online after April 29 by going to www.uhealthsystem.com. | |
| robsmith(Q) | my hearts skips beats and a pacemaker has been ruled out by the doctors at U of M. What other?treatments can be done for my condition? | |
| Dr_William_ONeill(A) | it is hard to say over the mail. I would suggest you make an appointment with one of our electrophysiologists (heart rythm specialists) call 305-243-4000 for an appointment. | |
| lisa_s(Q) | My dad had open heart 11 years ago he has a very low ejection fraction in the 20's he is having cardiac related liver and kidney problems. Can anything be don to improve his ejrction fraction | |
| Dr_Mauricio_Cohen(A) | Currently, there are multiple medical therapies for patients with low ejection fraction. The current standard of care include the use of the medicines aspirin, beta-blockers, ACE-inhibitors, aldactone, statins. Device therapy to prevent sudden death such as an implatable defibrillator can also be considered. In addition, pacing both ventricles at the same time, a treatment known as resynchronization therapy has also shown to improve symtpoms. Beyond these therapies, experimental studies looking at the use of stem cells can also be considered. A heart failure specialist should be able to address these concerns. You can access UHealth’s physician database at www.uhealthsystem.com, or call 305-243-4000 for a referral. | |
| carol(Q) | how far in advance to schedule a consultation? exactly where are you located from Boca? Is there a trial for laser spine sx such as offered at Laser Spine Institute? Who would I contact for that====different pt | |
| Dr_Alan_Heldman(A) | A medical examination is the best way to determine your eligibility for the clinical trial. If you have been diagnosed with aortic stenosis, or feel you may be a candidate for this study, please call 305-243-4000. We will see you quickly. University of Miami Hospital is the only study center in Florida. For spine questions, you can call 305-243-4000 and ask to be seen at the UHealth Spine Institute. | |
| jnadmin(P) | Thank you for joining the UHealth Breakthrough Medicine Web Chat. UHealth physicians are currently available to answer your questions and follow-up questions. | |
| lisa_s(Q) | Thank you I will call first thing in the AM | |
| Dr_William_ONeill(A) | good luck! | |
| JeannieS(Q) | How long is the valve expected to function or does it have to be replaced? | |
| Dr_Mauricio_Cohen(A) | We are currently performing the clinical trials to answer your question. The valve is made with the same materials as the surgical valves. Patients have lived for 5 years with a perfectly functional valve. | |
| Ivan_Baratz(Q) | are there any procedures similiar to the one showed for mitral stenosis? | |
| Dr_Alan_Heldman(A) | Good question. Mitral valve stenosis can often be treated simply by balloon dilation -- called valvuloplasty. We perform that procedure as well, and it is not considered experimental. For some patients, the mitral valve has become too calcified to respond well to balloon dilation, so in that case the remaining options would be medication or valve replacement surgery. | |
| sarah(Q) | Is there any chance that the valve would be attacked by the immune system? | |
| Dr_Alan_Heldman(A) | Good question. The tissue valve is very similar to the material that's been used for many many years in conven?ional surgical replacement valves, and immune reactions do not occur. | |
| liz_p(Q) | i have no insurance, or doctor. how would i be able to get a free heart exam? | |
| Dr_William_ONeill(A) | if you are really ill, you can go to the emergency room. By law, the hospital is required to treat you and they will try to obtain emergency insurance coverage. | |
| jjg(Q) | This is a follow-up question to my earlier question that began with "I have a friend, age 62, female, overweight, significant shortness of breath in need of valve replacement surgery . . . " Dr. Cohen asked for the type of valvular problem. She says her problem is aortic valve stenosis - bicuspid (sp?) valve. Thanks. | |
| Dr_Mauricio_Cohen(A) | Unfortunately bicuspid valves are excluded from the trial. She should see a cardiothoracic surgeon soon to assess whether or not she is an eligible candidate for the surgical procedure. If she has been turned down, she should seek a second opinion. You can access UHealth’s physician database at www.uhealthsystem.com, or call 305-243-4000 for a referral. Dr. Donald Williams and his team at University of Miami Hospital have excellent results. | |
| Lisa(Q) | What is the valve made of you are replacing? Pig, cow or other??Lisa | |
| Dr_William_ONeill(A) | The Edwards SAPIEN transcatheter heart valve is made from bovine pericardial tissue, or the protective sac that surrounds a cow’s heart. | |
| Pablo(Q) | I had a heart attach just about 40 days ago. I had three stents put in, and when I was your show, it caught my attention. Thank you very much. | |
| Dr_Alan_Heldman(A) | Good luck. One very exciting area of research for us now is the use of treatments to repair the heart muscle damage caused by heart attacks. We are currently studying the use of stem cells, obtained from the bone marrow -- these can be injected into the heart muscle. We're studying the results and looking for improvement of heart function. To learn more about this and other trials being conducted at University of Miami Hospital, visit www.uhealthsystem.com or call 305-243-4000. | |
| Harry(Q) | Im sorry I missed the show, is this procedure a full operation under full anasthetic?? | |
| Dr_Mauricio_Cohen(A) | Yes, the procedure is performed under general anesthesia. The show will re-air on channel 10 Saturday, May 9 at 4:30 p.m. and Sunday, May 10 at 1:00 p.m. The episode will also be available for viewing online after April 29 by going to www.uhealthsystem.com. | |
| Ivan_Baratz(Q) | would a person who has received an artificial valve by your procedure require blood thinner therapy for life such as coumadin? | |
| Dr_Alan_Heldman(A) | Aspirin and clopidogrel (Plavix) are given after the percutaneous valve replacement. Coumadin is not generally needed. | |
| sarah(Q) | Is the valve essentially permanently set or is there a chance that it later may move? Perhaps timeand your research will tell? | |
| Dr_William_ONeill(A) | so far there have been over 2000 patients treated world wide and there have been no cases reported of the new valve breaking off after it has been succesfully placed. | |
| Richard(Q) | ||
| Dr_Alan_Heldman(A) | This study is for treating only aortic valve stenosis. | |
| Adelana(Q) | Adelana: The heart surgery without an open heart surgery was first performed by who and where. | |
| Dr_William_ONeill(A) | this particular procedure was first done by Dr Alain Cribier in Rouen, France in 2002 I did the first procedure in the US in 2003 | |
| Lisa(Q) | LISA: Why are bicuspid valves not included & do you forsee this being added in the future? I hav e been diagnosised with a bicuspid aeorta valve! | |
| Dr_Alan_Heldman(A) | In some people, instead of the normal three cusps of the valve, they are born with two -- this is the "bicuspid" aortic valve. What may happen is that the valve gets stiff -- usually in age 50s or 60s. Right now, the best treatment for this condition (once it is severe enough to require treatment) is surgical replacement. In future, indications for the percutaneous valve will be expected to expand. | |
| JeannieS(Q) | How long does the valve last? | |
| jnadmin(A) | Dr_Mauricio_Cohen: We are currently performing the clinical trials to answer your question. The valve is made with the same materials as the surgical valves. Patients have lived for 5 years with a perfectly functional valve. | |
| sonia(Q) | My mother is 87 years old & suffering from aortic stenosis. She also has some renal problems from years of high blood pressure & diabetes treatment. Would she be a candidate for this procedure just shown on TV? | |
| Dr_Alan_Heldman(A) | Patients with severe aortic stenosis who are high risk or who are not candidates for conventional open-heart surgery are candidates for this study. Once a patient meets this criterion, further screening is conducted to determine eligibility to enter into this randomized clinical study. Additional evaluation/screening may include echocardiogram, CT Scan, electrocardiogram (EKG) and catheterization. To learn more about the aortic valve replacement clinical trial being conducted at University of Miami Hospital, visit www.uhealthsystem.com or call 305-243-4000. We would be glad to see your mother. | |
| NINA(Q) | DR.oneal: I am a 65 year old female with high blood pressure, and type 2 diabetic and have been diagnosed with 80-85% carodid stenosis on my left side of the neck. I'm very fearfull of surgery (CUTTING ON THE NECK AND CLEANING OUT THE CARODID ARTERY) I'VE HEARDABOUT C.A.S. stenting angioplasty done in clinical trial, would this be available and safer for me and less dangerous. Thank you, nananina | |
| Dr_William_ONeill(A) | The carotid stent procedure is very effective for people like you. Dr Omaida Velasquez is a superb doctor that is the cheif of vascular surgery. She does both the stent procedure as well as the surgery so she would be ideal to see you about this. You can reach her at 305-243-4000. | |
| Nadejda(Q) | Hello. I am very happy that there is procedure like that. My father passed away after 4th heart attack. I wish he could live at this time. I watched the program not from the beginning and wondering what is the price for this procedure? | |
| jnadmin(A) | Patients and their insurers are billed for the aspects of their care that are clinically?indicated, including (should they receive it), the valve implantation. Aspects of their care that are required only for the study (including some screening and some follow-up tests) are not charged to patients or their insurers and are covered by the study. | |
| joanna53(Q) | will my question be answered as there seems to be lots of repeat and follow up questions | |
| jnadmin(A) | Our apologies. We have had an incredible response to the show. If you resubmit your question now, we can answer it immediately. | |
| Sharon(Q) | Does patient with moderate dementia qualify for procedure and pose any special risk? | |
| Dr_Mauricio_Cohen(A) | A person with dementia would not qualify for the study. Patients are eligible if they have normal cognitive and neurologic function. | |
| liz_p(Q) | the progarm did mention that i could find way to recieve a free heart exam by comig online to find asst | |
| Dr_William_ONeill(A) | you can go online to the heart aware portion of the website to get the free exam. or you can call 305-689-1000 | |
| Lori(Q) | What is the "normal" diameter that the aortic valve opens to? Is there a diameter that indicates need for critical attention? | |
| Dr_Alan_Heldman(A) | We focus on the *area* of the valve opening -- in square centimeters. A normal aortic valve opening is greater than 1.5 cm squared. For this trial, eligible patients have severe aortic stenosis with a valve area less than 0.8 cm squared. The most important indicator of needing critical attention is the development of symptoms -- typically chest pain, shortness or breath/heart failure, or fainting. If these happen with aortic stenosis, it is time for urgent attention. | |
| sonia(Q) | Sonia- I asked myquestion about 15 minutes ago .. but have not seen an answer. My mother is 87 years old and has aortic stenosis. She als has renal problems from years of high blood pressure treatment and diabetes. Would she be a candidate for this procedure? | |
| Dr_William_ONeill(A) | i am sorry, we have been bombarded!! She sounds like a very good candidate. Pleasecall Phillip Gonzalez at 305-243-4953 if you wish to find out more about how to enroll her in the study. | |
| Lori(Q) | Is the surgery you showed on tonights show also called the Miami Method? | |
| Dr_Mauricio_Cohen(A) | The name of the procedure is percutaneous aortic valve replacement. This procedure is done as part of a multicenter clinical trial with a few sites in the US and Canada. Therefore I do not think that the name "Miami Method" is applicable for this procedure. | |
| liz_p(Q) | how would i be to sign up for a free heart exam? | |
| Dr_William_ONeill(A) | call to make an appointment with a nurse screener at 305-689-1000 | |
| joanna53(Q) | why is the aortic valve replaced more often than the mitralvalve? | |
| Dr_Alan_Heldman(A) | Aortic stenosis is the most common valve lesion -- and is getting more common as our population ages. Aging is the biggest risk factor. Mitral valve surgery is also commonly done at our hospital. | |
| joa?na53(C) | why is it that the aortic valve seem to get replaced more often than the mitral valve? | |
| Marion(Q) | My mother had her aortic valve replaced with a porcine valve and a double bypass in 1995, she also has a pace maker. When the porcine valve needs replacement, can this procedure be done in that situation? she is 87 years old | |
| Dr_Mauricio_Cohen(A) | This procedure is only performed for patients with native valves. Therefore someone with a previous valve replacement would not qualify for this study. | |
| Marion(Q) | Is someone who has had an aortic valve replaced with a pig valve a possible candidate for this type of procedure when the pig valve begins to fail? | |
| Dr_Mauricio_Cohen(A) | Only patients with native valves are eligible for this study. | |
| JeannieS(Q) | What is the average life expectancy after this procedure and is your activity level the same as before the procedure? | |
| Dr_William_ONeill(A) | the biggest advantage is that people feel much better after the procedure. since most people are very old, we do not really talk about life expectancy. Quality of life is markedly improved. | |
| sheila(Q) | my husband is 78 years old - he has a pacemaker. | |
| Dr_William_ONeill(A) | Sheila thanks for watching the show! I hope your husband is well, is there a question we can answer? | |
| sonia(Q) | Sonia- f/u question - Dr,Heldman- thank you for your response. This catherization would be with a dye - correct? We were told that any kind of dye testing would put her into kidney failure and dialysis? Your thoughts? Thanks again | |
| Dr_Alan_Heldman(A) | Good question. X-ray dye (contrast) can be toxic to the kidneys. At University of Miami Hospital we can do catheterization in a special room that gets two X ray views at once, so the amount of dye needed can be minimal. This and other techniques can minimize the risk of renal failure. | |
| Michael(Q) | Dear Doctors, Very impressive effort with Patient Koppelman. Thank you | |
| Dr_William_ONeill(A) | we are so happy you watched! Thanks for the nice words! | |
| Ivan_Baratz(Q) | My father is 88 yo with diabetis, severe mitral stenosis, mild aortic stenosis and mild tricuspid regurgitation. Could he be a candidate to repair the aortic valve? | |
| Dr_Alan_Heldman(A) | This trial is for treating severe aortic stenosis. Mitral stenosis can be treated in ways that are not experimental, including with a balloon (valvuloplasty) or with surgery. | |
| joanna53(C) | thanks, this is fascinating cutting edge procedure right in our own backyard | |
| Sue(Q) | Dr. ONeil: is ASD repair performed the same way as the valve stenosis procedure minus the temporary stopping of the heart? | |
| Dr_William_ONeill(A) | the heart does not have to be stopped. We also do ASD repairs and this is an excellent and well accepted treatment. | |
| Michael(Q) | In 2001, i experienced a complete pneumonectomy which was followed a few days later by an undis?overed MI of the left ventrical. Significant damage was done before the heart attack cause by a blood clot was discovered. Since, I have a heart pumping function of 35% of the norm. I am now a patient at Miller School of Medicine. Is it possible that my being disabled might be remedied by this type of surgery? | |
| Dr_Alan_Heldman(A) | One very exciting area of research for us now is the use of treatments to repair the heart muscle damage caused by heart attacks. We are currently studying the use of stem cells, obtained from the bone marrow -- these can be injected into the heart muscle. We're studying the results and looking for improvement of heart function. To learn more about this and other trials being conducted at University of Miami Hospital, visit www.uhealthsystem.com or call 305-243-4000. | |
| PK_in_Broward(C) | Congrats to you all! And THANK YOU for bringing 1st class cardiac care to our community!! | |
| michelle(Q) | I am 55 yr old femaile and have had PMV for 20+ years with no remarkable problems. 2 years ago a suffered a full cardiac arrest and have a ICD. Recently it has been discussed that the moderately severe PMV could be the 'trigger' for the V-fib arrest and I should consider repair/replacement. am I a possible candidate? PS is Dr. Myerberg on your team? | |
| Dr_Alan_Heldman(A) | The procedure shown on this program is just for treating severe aortic stenosis. Of course our team is interested in other cardiovascular problems including ones like yours. Dr. Robert Myerburg is indeed an important leader of our faculty and is a world authority on cardiac arrest and other arrhythmias. Good luck! | |
| jnadmin(P) | Thank you for joining UHealth’s Breakthrough Medicine Web chat. We appreciate your questions and your feedback. The discussion has closed. If you are still interested in learning about Breakthrough Medicine, the aortic valve replacement clinical trial at University of Miami Hospital, or if you have any other questions about UHealth — University of Miami Health System, please call 305-243-4000 or visit us at www.uhealthsystem.com. Web chat archives will be available on our Web site beginning April 29. | |
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Stem Cell Therapy: Healing Force of the future
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