Angio-seal Complications

**Originally posted by user WomenHeart 06/01/2005 : 13:30:52 **

I had an angioseal inserted after having a artigram done on 10-14-04. I was not aware that a angioseal was going to be used. After the procedure my blood pressure bottomed out a couple times then stablized to normal. Well I was released to go home same day but right leg was real heavy feeling and had to drag it behind me like. I thought this was normal and on MONDAY the 10-18-04 I called the Dr. his nurse said that was not normal and scheduled an ultra sound for me on 10-19-04. Well ultra sound found an aortic aneryseum in my groin area which required surgery to remove it. Then I was hospitalized several times afterwards due to complications from both procedures. Then I had to heal from an open wound and had to have home health nurses to come to my home everyday for three months then a friend of mine had to come change bandage everyday until I healed up. My wound has finally closed up 2-14-05 but my leg still hurts, burns and pinching feeling in groin area all the way down to almost my knee. If I am up on leg for any period of time it becomes real bothersome and I have a numb tingling sensation all of the time. The right leg feels bigger than left leg and right leg is swollen on inner part of the thigh(like a pocket of something.. fluid).At the top of the incision sight there is a hard lump which is sore and Dr now beleives that it may be a pocket of infection. But don't seem to make any effort to determine what it is for sure they just keep writing prescriptions for hydrocodone pain pills. Anureyseum was caused from ANGIO-SEAL. If anyone hears of anyone to contact or hears of any class action being taken please post it or EMAIL ME THANKS,SHANNON PIGS1LADY@CHARTER.NET

SHANNON

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38 replies. Join the discussion

**Originally posted by user fedup 08/02/2005 : 19:11:55 **


I had a heart cath done on 7/28/05 and had the angio-seal used. I have been having the same pain a lot of you have been having. Groin pain, esp. after sitting and when I get up to walk I can't hardly walk and I limp. I thought all this would just go away. However, I started experiencing my leg going out from under me a couple of times. Has any one else had this problem. This has been happening more than once. I almost lost my balance and fell down our stairs due to it. Since it has only been a few days I am dreading what is to come. Please someone reply. Thanks. Djpal@comcast.net.

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**Originally posted by user Texheart 08/03/2005 : 15:37:56 **

I have had three caths. The first one, angio seal. The second one angio seal. The last one (last month) I asked for an angio seal as I knew I could get up in 2 hours and not have that heavy weight placed on me for hours. The New Heart Cath doctor said, No, I do not use them as I do not like them! So, I had to lay 8 hours before getting up. I did have something after the first cath like an open whoozing area for 2 weeks after this cath. I had to use neo-sporin and sterile gauzes on this area for 3 weeks. I like my last Cath doctor better than the first one so if I have to have another cath..I know I will not get the angio seal.

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**Originally posted by user pigs1lady 12/20/2005 : 18:44:42 **

Shannon
Hello it is me again well I have had to have another surger because the procedure I mentioned above I almost lost my right leg and foot. It was showering small blood clots all down my leg and setting in my foot. I am now having to take Plavix and several other meds but nothing stops the pain or helps me to get up and do the every day things I once did. My new Dr. says eventually I will end up loosing my foot if not my entire leg. Since surgery 09/13/05 I have two more blood clots and to develope and I am still healing from that surgery (open wound) again!!! After I get healed from this one they will have to do surgery again to remove these new clots. All of this is from a angio-seal being used. Now my life will never be the same and I am only 34 years old!!!!!If anyone knows anything I can do to me let me know please!! Email me at pigs1lady@charter.net.

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Hello to everyone! New to the discussion, but was very interested to hear all of the complications going on with Angioseal. I myself am a cathlab staff member who puts angioseals in patients. I also work in the cardiologists office post procedure. In the 18 years I have worked in the cath lab, Angioseal has only been on the market for about 3 years. In that last 3 years, I have seen 5 complications out of the thousands that we put in. I'm not sure about the hospitals that you go to, but at our hospital, our patients are very informed about their procedure before they go in, including on the 3 different closure devices we have. So, don't get upset with the docs for not telling you which one they are putting in, everyone should be an advocate for their own health and research their procedure before they come in. That way they know what's going on. If I had someone telling me that they were making a hole in my artery, one of my follow up questions would be "what are you going to do about the hole when you are done?" Secondly, most of the patients that come into the cath lab are larger than normal, and those patients have higher risk with putting in closure devices. There is alot more tissue to go through to get to your artery and therefore there is more risks associated. Last of all, there are 3 ways to close an artery: Angioseal, Starclose, and manual compression. All three have lots of risks. More so with angioseal or starclose, but if they put you on blood thinners at all, you can't do manual compression. With everything there is risk, and it's our jobs to make sure that you know all of them before you go in. Sometimes there are emergencies and in that case the doctor is going to make the best decision for you. At times, you need to have these devices put in for certain reasons! More people should be advocates of their own health and research more. We are going to do the best we can to inform, but you know how many times I have told one of my patients the same thing over and over again. Sometimes people just don't listen or they don't care what you have to say. Unfortunately we can't do anything about that. I'm sorry to get on her and let it all out like this, but it's very frusturating to see people try and scare people out of getting an angioseal, when that might be just what they need!

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Cathlabstaff.....I respect your opinion, and even agree with the fact that we are our own advocate. But until you are laying on that table in an emergency, don't tell me that you are going to be asking how they are going to seal the angio puncture. We are worrying about surviving. Not leaving our children in this world to grow up without us. I didn't care if they cut my leg off as long as they could fix my heart! I am 38 years old and didn't research angiograms..because I didn't think I had heart disease. There are plenty of woman who are not in your words.."large" and I am disturbed that you would catagorize us as such. I don't know about the other members, but I was not told there were 3 options, nor was I given an option of the closure. I remember the nurse asking the Dr. to be nice and put a stich in and then I had to lay still for 4 hours. I didn't have any problems, and don't know which of the 3 I had, but I couldn't just sit back and not respond to this email. On last thing..no one on this site is trying to scare anyone on a procedure. We just give our experiences and support. We are sisters in a horrible disease and we support each other. Until you walk in our shoes don't judge. Treze

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Cathlabstaff:

Welcome to this community. When I saw your id listed among the new members I figured we'd be getting some expert input. While I can agree with many of your statements about patients being our own advocates and paying attention to instructions, I have to agree with Treze and add something. Heart patients do indeed come in all shapes and sizes and each has an experience in the cath. lab unique to them.

I have been cathed 6 times beginning in August 2005 when I received my first stent. I had an Angio Seal for one of the procedures with no complications. I had manual compression for all of the others. You said that "if they put you on blood thinners at all" they can't do manual compression. So what happened with me? In August of 2006 I had an abnormal stress test which indicated another blockage. I had been on Plavix for a full year and was told to keep taking it until the day before the procedure 2 days later. This cath. took 4 hours because a student was allowed to assist. He ended up poking my leg 4 times to get the artery and the doctor kept ordering Heparin during the procedure to keep clots from forming. I had manual compression and could not move that leg for 12 hours. This was done at St. Luke's Heart Center in Houston, TX by a dr. from Hall-Garcia Cardiologists. I guess different cath. labs, different doctors, different staff, varied treatment and protocal. That also means different patients, different experiences, different outcomes.

I appreciate your joining our community. We always welcome the chance to educate members of the health care profession to the problems we deal with daily in dealing with heart disease and health care professionals.You say some people don't listen or care when you talk to them. We feel the same about how the medical community often treats us. I hope that you can learn as much from us as we can from you.

Dianna

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Heart Sisters and Cathlabstaff...I would like to apppologize for my post last night. I let my emotions get the best of me. Like Dianna said...I am one that feels let down by the medical professionals....but I am lucky since I was able to avoid heart damage. There are many of you that DID suffer heart attacks due to not being listen to and taken seriously. I 100% appriciated my cath lab staff. They did an excellent job, were very kind and understanding, and very concerned with me. I think they were probably more shocked with my age and what was going on wih me and felt sorry for me. I was very very scared and they were keen to that and went out of their way to easy my mind as much as possible. Dianna you so poetically stated everything i wanted to say, and in a much more professional mannor. Cathlab...thank you for letting me know and opening my eyes that there are 3 different options of closure and that I can discuss this with the Dr. if not an emergency. Once again...please forgive me for being so emotional and blunt in my previous post and thank you Dianna for showing me a more proper way to express my opions. I love and respect each and everyone! Treze

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Again, I understand where you are coming from and I am sorry for the complications that it caused you. Your case is different because it sounds like you came in emergently, and yes in that case you don't have much options as to anything they do for you! I'm talking about the people who come in electively having have time to do the research. If you guys are trying to help each other and share your stories that's fine, but my comment was to those who were telling others "NOT to get an angioseal." Every single patient is different and has different needs. Your stories are appreciated because the people who are reading them, are the ones who are researching this product! That's great! But you have to realize that it's one thing to share your experience and another to try to tell other people what they need and don't need. You are not their doctor. And about the women being "large", I was only stating the facts. I have no idea what any of you weigh, I was just letting you know that if you are larger, there are more risks. Just letting others who research know, that if they are bigger woman, then maybe angioseal is not for them. Once again, just giving advice not putting anyone down. All I'm trying to say is that everyone is different, going to different hospitals, different cardiologists, and there are good docs and bad docs. You have to do the research to find out where your cardiologist and hospital fit into either of those categories. Once more people are going to good docs and good hospitals, these problems will start to disappear. Just be careful and make sure you know what's going on with your health.

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So as someone with expertise in this area, you've obviously compiled all the complications we're describing on this message board and taken the issue to a higher authority at your hospital so that our valuable feedback can be forwarded to the manufacturers of these closure devices?

To paraphrase, don't shoot the messager; act on the message.

Thanks, in advance, for being an advocate for your patients and all of us who've endured failures and complications associated with Angioseal and Starclose.

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It is so good to hear from someone that had stenting done at St. Luke's (Houston). I had my first stent done during an emergency - ( had a massive heart attack in 2004) - but next stent was closed with manual compression, the next 2 and I've had 3 w/o compression at Methodist (Houston). I have noticed some discomfort a few weeks - then the discomfort becomes
very minimal.

I have learned so much about the the 3 different kinds of closure.I hope that I'll be so blessed not to have one in the future - but if I do - I'll be more informed.

Take care my heart sisters

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One week ago I had an angiogram and a seal was not used but manual pressure. The recovery nurse told me that was a preference of my cardiologist. I am a nurse practitioner and feel pretty knowledgeable around medical procedures and complications. I also know that there are always complications although how many per thousand needs to be looked up.
I would like to comment on how I decided to have the manual procedure, well I didn't. Let me explain, I have access to all of the latest research and I do my homework, I look up everything.
But my biggest intellectual confident is my doctor, I have made sure that she is a competent and I trust her judgement when making these kind of decisions. I'm sure if I had requested a different closure she may have consented but I trust that with her experience and skill for many years she feels this is my best option. I guess the trust and partnership I have with my cardiologist helps me to feel she will choose what is best. This is not to say I blindly follow whatever she says and sometimes I will question but in the end I feel she has the years of experience and I trust her judgement.
But even with the best treatment I realize there may be complications and then when you are that one it takes on a whole different meaning to you. Also, when people start having complications more and more from a procedure ,doctors and manufactures start paying attention so it is good to share your stories. It is also good to hear from cathlab who seems to see many of these proced ures and that most go along smoothly.

I do have a question from you guys, the area in my groin is still very sore, and there is a lump. I'm asuming this is normal. I know I don't have any of the symptoms that some of you have experienced and am thankful for that. I hope that all of you will heal completely without serious complications.
Kandice

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I had an angiogram a little over a week ago and the soreness and lump are normal. You have to watch carefully for signs of infection and watch the lump so it doesn't get bigger. But they are normal according to the discharge paper I got from the hospital. I think the soreness can last a week or two but should start getting better soon. The lump can last for several weeks but will eventually go away. Good luck and God bless, Mel

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Hi cathlabstaff,
I have more questions regarding the three different types of closing. I think I must be a little slow since I still don’t totally understand the differences between the three.
I have had five heart caths. Each time they came into the holding area after the procedure with this machine and put some precise pressure on the groin area for a few minutes, it looked complicated –that was all–. Then I had to lay perfectly flat for about 8 hours before I could get up and walk around a little.
10 hours after my first cath and stent implant I had a heart attack while in the hospital and they did an emergency cath with another stent. The trauma of that emergency cath caused me to have blood clots in that leg ---for about 9 months--.
When you say, they put pressure on the site, does that mean constant pressure for hours (like an object or something); and what is the third option???
I hope I don’t sound foolish.
R.

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Bowmanka:

In response to your question about the lump in your groin and the soreness, yes - it is very normal after a cath. I was told after my first that sometimes the puncture site will form a walnut sized lump in response to the trauma to the tissue. In my experience, I had it 3 out of the 6 times I was cathed. I also experienced soreness ranging from 2 weeks post cath to up to a month.

I am glad that cathlab is here to share her professional experiences, but she failed to address my concern about her statement about the 3 types of closure. She was adamant that if you are on blood thinners you cannot have manual compression. I have been on blood thinners since my first stent and had manual compression with 4 of my last 5 caths. I am also a very informed patient who uses a world renowned heart hospital and cardiologists who were trained there.

Again, your lump and soreness are normal. Warm baths and ibuprofen helped me through it. Also, when it gets really sore moving around, believe it or not, will actually help. I found my groin area would get really stiff if I sat for too long at a stretch.

Take care -

Dianna

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I am new here and spent the last few days reading. I apologize but have to chuckle at CathLabStaff a bit. First off, I think this person is a he and a young he. You mentioned that MOST patients coming into the Cath lab are larger. I think a better terminology would be, instead of using the word "most" use the word "many". When I had my three cath's I think I was the biggest of all those lined in a hallway much like a cattle call. (-: and I am about 20 lbs overweight. I thought I was the most informed person before my first and subsequent cath's. I asked questions and certainly did not ask about various types of closures. The doctor said the puncture would be closed and I would return to my room. I had no idea that I was suppose to ask him if I had choices. I do not think I am an ignorant person and I fault the doctor/s for not informing the patient about the different closure, types.

I too am in Houston and have stories to tell about my experiences. My first Cath, i thought I was on Candid Camera or at least America's Funniest Video's...but it was not a laughing matter. The staff was awful, the head cath doctor was brutal and the intern in training was a frightened, novice. He could not get the stent in. I was bruised from head to toe and oozed from the incison for weeks, afterwards. I was told there would be a nurse at all times at my head...There was no nurse.
They slapped a sand bag on my groin and I layed with that thing on for 8 hours. They put the fear of god in me that I could not move for 8 hours. I held my urine in fear. For supposedly being a top notch heart hospital, I rated it in the cellar. The second cath was not much better. They did have a nurse with me, this time. I thought I would be sand bagged but somehting else was used and I was able to get up in 2 hours. I felt terrible like a truck on my chest. They sent me home feeling like this, the next day, but I ended back in the ER room, a day later, with elevated heart enzymes and was sent home again when they found out I had just been cath'd and figured someone nicked an artery during the heart cath. (later I learned I should never of been sent home)
Third cath...new doctors...new hospital, same city. I asked, the no nonsense cath doctor, about the closures. He would not use anything but the sand bag method. (manual compression)
Now, with both the manual compression methods, I was on heparin pre-op and then loaded with plavix in the cath lab.

CathLabstaff, you state that some people do not lsiten to you or perhaps do not care what you have to say. We listen alright and we do care but when you are being wheeled in or laying on a gurney in a hallway waitng for a scarey invasive procedure, we cannot be all peaches and cream and smile and be jovial and nod our heads with everyhting you are saying to a patient. Pateints are not that difficlut...I feel it is the hospital staff that can make things difficult for the patient, often times. I know..I have been there. I am the Queen of their errors and their flops and paying the price for this, now. Yes, hospitals can save lives but they can also harm and kill a patient.
Having the Good Housekeeping Seal of Approval means nothing to me, now. I go by what other patients have to say about doctors and hospitals. You are almost guaranteed the true facts.
My husband will be having a cath this week. I am ready. Tonight he thanked me for being up on everything and not taking a back seat to ignorance and rudeness. We pay dearly for good service and by golly we all deserve it. Hopefully, we will have one of the very best cath doctor's in our city, doing it. He takes no new patients but he is being called in. Thank God.

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Dear Heart, (couldn't resist!):

Your story of the hospital in Houston was very similiar to the experience that I and at least one other lady on this board had at St. Luke's. I don't know if that is where you went, but I agreed to have a "Fellow" in the room observing the procedure. I never imagined he would be allowed to train on me. While in the cath. lab my IV malfunctioned - all the Heparin and drowsy medicine they gave me went into the sheets. I heard every word being said in the lab. I heard the dr. instructing the fellow - "right there, now go slowly - no that's too far. Start again." I was in the cath. lab so long my family started freaking out thinking I was having bypass. I know this intern was at my hip where the dr. should have been because I could see his turban (no ethnic offense meant - he had on a large, navy blue turban ) and I could see it over the x-ray machine right next to my groin. I heard the dr.'s voice giving him instructions from far across the room. He was no where near close enough to be doing the procedure. I tried telling them when the medicine wore off. I could hear everything and feel everything. The doctor told me to hush - that I was imagining things in my medicated state. I kept asking them to please listen to me. Thank goodness a nurse checked. She yelled out "Her sheet is soaked - she hasn't gotten any of the Heparin and the *#@*&* (whatever the relaxant was). We have to fix her IV. Get me more Heparain NOW before she starts clotting". Everything stopped for about 10 minutes and then proceeded. I was in the cath. lab over 4 hours for 1 stent.

I immediately told my hubby and parents what had occurred and hubby confronted the dr. right away. The doctor told him he had done the entire procedure and it was the meds. that made me imagine it all. I burst into tears. You could tell my IV had been redone. The tape marks were still clearly red on my arm from them moving it around. I didn't imagine any of it. I still remember every moment in that cath. lab. They were even talking about beach vacations and time away from work. We later counted 4 - 5 puncture sites from the fellow not be able to get the sheath for the guide wire set. right. I, too, was bruised horribly. The worst part is the doctor lying to my husband's face in front of me. I wasn't in the right frame of mind to confront him at the time. My husband knows I was telling the truth, but it didn't serve any purpose to pursue it.
I had my 2nd stent and what was done was done. I will NEVER have another procedure at St. Luke's unless I am able to sign something 100% guaranteeing a Fellow will not be allowed to even observe. I don't want any trainees anywhere near me again.

Good luck to you and your husband with his cath. this week.

Dianna

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I had a feeling that many people were going to attack what I'm saying, but realize this....I wouldn't have come onto this website and wasted my time talking to people if I didn't care. I was frusturated at people when I first read about how awful staff and hospitals are, and how horrible it is that we don't tell the patients anything before we do it. So my comments might have come off a little harsh. If you want to "chuckle" go ahead, but I have lots of information to share with people on this website and thought it could help. Apparently some people don't want help and just want to vent about their issues. Well, for those of you who have questions, I would be happy to answer them.
Secondly, I am not a male, I am a female. I am on the young side, just turned 30, but I myself have had a heart cath. Just not for the same reasons that you women have had them. My cath was not to look at my coronary arteries, but to fix a hole in my heart. I recently had a pfo closure done. Same exact procedure, just doing different things up in the heart. I thought I had all the info, but until you are on the other side, you have no idea. Luckily since I worked there, and knew my doctor on a personal level, I had told them exactly what I wanted for closure, IF they were able to. I chose angioseal, and to this day have had no troubles. Hurt a little going in, but that's all. I know how scary it is, and how awful it can be, but you have no idea how many people come thru my doors with the worst attitudes. OF COURSE there are good people, probably like you all, that are different. I've come onto this website to inform people on how to be good patients and on how to be informed. I'm done with the bashing and will only be replying to those who want my advice or opinions. Thanks

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Of course you don't sound foolish. You have to realize that I work in Arizona and what I tell you is how our hospital runs. It won't apply to every hospital procedure. There are actually more than 3 closures, but I only do 3. Angioseal is a collagen plug that sits outside the artery. There are "footers" made of collagen that sit slightly inside the artery also. Those footers are there to let us know when we are in the artery. They dissolve within about 90 days. There can be complications with the footers not coming out correctly causing what we call "cold leg". Thats when the footers are in the artery but not in the correct spot, therefore they block blood flow down your leg and can cause some serious damage. If you are a thin person, you might feel a peanut size lump under your skin, that is the collagen on the outside of your artery. There is a small window of oppotunity to use this device, the doctor has to have what we call" a perfect stick" in the artery. If you have bad arteries, calcified arteries, anything like that, we can't use it.

Second is Starclose. I'm not a big fan of this device, cause it leaves a tiny clip in your body forever. Also, they seem to hurt the patients more when I put them in. It's a tiny, tiny clip made of nightenall, that grabs your artery on the outside and imbeds itself into the wall of your artery to stop the bleed. It works well when used properly but doctor like to use it "off label" a lot. Meaning we get a lot of "failed" devices.

Third option is manual hold. I stated in my first comment that you couldn't do manual hold after being put on blood thinners, I meant that you couldn't do it in the cath lab. Your blood is too thin to take your sheath out. You have to wait for hours till your blood thickens up, then its taken out. Manual compression pinches the artery so that only a small amount of blood gets through forming a small clot where the needlestick was. This is a temporary clot and it takes about 8 hours for a permanent clot to form. I pull the sheath out and hold pressure on your groin for roughly 15 minutes. I lift my hands to check, and if it stopped bleeding, then we put a bandage on it. If not, we can use clamps, large machines, sand bags to hold pressure for us. (hurts my fingers like crazy to hold pressure!) I hate using the machines, but sometimes my hands hurt so bad we have to. If the person pulling the sheath cannot get control of the bleeding, you can bleed under the skin (hematoma) and those are really painful. Your artery is large in your leg, plus you normally have a bounding pulse, sometimes making it difficult to control. It's a tough job, and painful for the patient. Not to mention the 8 hours of bedrest after. For starclose or angioseal, it's only about 2 hours bedrest.

They put the fear of god into you about laying flat cause if you bleed during that 8 hours of bedrest, the whold process starts over again. I have to hold pressure for another 15 minutes followed by another 8 hours of bedrest! Get rough!

Anyways, I hope this helps.

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Hi cathlabstaff,
Thanks you so much for your great and informative response to my (foolish) questions. Your comments certainly helped me understand the different methods of closing the artery better.
I personally think that I am pretty well informed regarding my heart disease, but when I get into the cath lab --mostly in an emergency situation-- there are so many things to worry about that one does not have the mindset to ask all these detailed questions.
Thanks again, cathlabstaff!

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Thank you for those explanations. They were never explained to me nor was I given a choice. In Feb. I had a heart attack and so I had to have an angiogram. My local hospital could do angiograms, but not fix any problems they might find, so they would transfer you to a hospital an hour away, with the sheath still in, for any necessary procedures. My sister, who is an RN suggested that I go to the other hospital for the whole procedure. So I was transferred before the angiogram. At that hospital, I had manual compression. The only thing I was told was I had to lay still for about eight hours, which turned into 12 hours. I was in a lot of pain from my back after about four hours, so that was not a fun time. I also had problems when they pulled the sheath. I kept passing out. The nurses were panicking and that did not help. I heard one of them say, "oh no!" Suddenly there were people all around and yelling and alarms beeping. I thought I was dying. I was in and out of consciousness and I felt tingly all over. I was later told that I was not in any danger, and I recovered quickly.
When I had problems in August, The doctor wanted to do another cath, and my husband talked him out of it because of that experience. Then it became necessary last week, so I had no choice. The hospital in our town can now do stents if necessary, so we opted to stay there. This time they used a starclose. When they asked if I was ready to get up and walk after only a few hours, I was shocked. I asked about it, and they told me there are different ways to close the artery and they used a quicker way than the other hospital. They gave me a paper about the starclose, but it kind of confused me. But I was happy to be up and around after only a few hours. I had no complications with this method either. I was able to go home about an hour later and have had no problems. I appreciate the information. It has been helpful to me.
Mel

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