Angio-Seal, StarClose and Vascular Access and Closure Devices (2006 archive)

• Is the StarClose device MRI safe?
April D., Washington, USA, December 28, 2006

• Also the allergy reaction may be due to the contrast that was injected during the procedure. Do you have an allergy to iodine? seafood allergy? if so this may be the reason behind your rash.
John Doe, Phoenix, Arizona, USA, December 7, 2006

• Jeanne -- Starclose is made of nitinol, a memory-shape alloy made of nickel and titanium. Collagen is used in other devices, but not in the Starclose. Do you have any metal allergies? Possibly an immunologist could help determine this.
Angioplasty.Org Staff, Angioplasty.Org, December 6, 2006

• I had a diagnostic cardiac cath 3 weeks ago with StarClose device (negative for CAD) with no stents. Besides the horrific folliculitis post op, I broke out into a very bad rash with lesions on my abdomen and genital area which cleared initially after use of antihistamines and topical cortisone cream. However, since that time I've had systemic rash (raised bumps that itch) occurring in different sites on my body and now the abdominal rash and lesions have returned. I'm trying to find more info on allergic reaction to the device (nickel or collagen) and the treatment.
Jeanne G., Virginia, USA, December 6, 2006

• My sister had a right heart cath yesterday, and an angioseal to close the artery. She feels very ill, nauseous and weak. this a.m. she got up to go to the bathroom and felt very bad pain in her groin and she has a 'lump' there that is very hard. Any advice on what questions she should ask when the on-call doctor calls her back? we are worried that it's going to turn ugly. She has lots of little girls at home that she needs to take care of :) Thanks.
Angela L., Nebraska, USA, November 25, 2006

• Has anyone had any problems related to the Boomerang closure device by Cardiva?
Amy, Pennsylvania, USA, November 8, 2006

• Commonly quoted compliation rates for closure devices may be understated, especially for infections. Rates stated during company sponsored testing often tend to be low, not because of any chicanery, but investigators have the benefit of close sponsor supervision. A trial is in progress to measure device closure against manual compression. http://www.clinicaltrials.gov/ct/show/NCT00264264
R.J., California, USA, November 6, 2006

• I am responding to the need for a stent post intravascular closure. I was a cath lab RN for years and I have seen on occasion where a stent was placed if the device was deployed intravascularly. It is a first ditch attempt to regain flow before sending the patient for a more invasive vascular surgery correction.
A.R., Virginia, USA, November 6, 2006

• Jimmy from Pittsburgh and Mark from California -- regarding the StarClose device, yes it is a new closure device so we haven't gotten very many postings about it. I have asked several cardiologists about it and have gotten pretty much positive feedback from them. One of the problems with collagen-based "seals" is either hypersensitivity reactions to the collagen, or the seal not making sufficient contact with the puncture site to secure the seal. These are a couple of reasons why a different type of device, like the StarClose, was developed in the first place. Studies that have been done, prior to the StarClose, show that the complication rate for femoral punctures is not improved by any of these devices -- somewhere around 3% of patients have complications with or without femoral closure devices. Of course, the 97% who don't have complications with either manual compression or closure devices do much better with the closure devices, because they don't have to lie flat on their back for many hours.

One thing that has to be kept in mind is that if the initial femoral puncture is not optimal, the complication rate goes up significantly, whether or not a femoral closure device is used. The challenge for device manufacturers is whether or not their product can close a suboptimal puncture more successfully than manual compression. That being said, we welcome more submissions from our readers, either pro or con, about these devices.
Angioplasty.Org Staff, Angioplasty.Org, October 29, 2006

• I am a 55 year old male. I had an angiogram about 5 months ago based on some odd things on my stress test. My heart was determined to be fine and clear and a starclose clip was used to close off the artery in my groin area. It seemed fine at first but I always had a problem lying on my stomach in bed with the puncture area flat against the bed. More recently I have been having pain and some swelling, maybe for the last one to two months, in my groin area up to my hip. At times the pain is considerable. Something seems to definitely be wrong. The ligament or something that runs from my hip to my groin area in the crease between the leg and groin seems swollen and sore. It always hurts in this area when I drive to work and feels like it's pinched. And I have to sleep oddly to avoid lying on it even more now. I'm wondering whether the clip is aggravating a tendon or ligament? Or is it possible after all this time the artery could be periodically leaking at the puncture site internally or maybe would leak if I did too much physical work/etc.? I saw my regular gp and he did an xray and the clip still seems to be in place. We thought trying motrin might help but in hindsight this seems not to get to the root of the problem. My next step is to ask to see the cardiologist again. I know this pain and swelling is not normal and I never had any kind of pain here before. Any advice is appreciated. .I would appreciate any similar experiences and any advice available. thx.
Mark F., California, October 22, 2006

• I had a Heart Cath and The Cardiologist used this new Device called StarClose without telling me that he was going to use it. The Doctor told me originally that He would use a Collagen Plug. I asked this in His office the week before this procedure. Well after He was through with my procedure and I was in recovery I was handed a document saying my Artery was closed with this StarClose Device -- it even had a UPC CODE for this piece of metal that was inserted into mt body without my permission. I have had nothing but Severe Pain in my groin and pelvis down my leg my lower back and my hip I can not even lay on my right side or lean forward without me screaming in pain. I even have to help pick my right leg up to get into my car. I can not walk right or even exercise. This device is star shaped and metal and is SHOT into your body which grabs everything and anything around it. I was told to see a Vascular Surgeon I saw two of them. Since this device has only been on the market six months the first Vascular Surgeon had no clue what it was. The second Vascular Surgeon said he has had nothing but trouble with this StarClose device and he had to remove it 5 times out of patients because of problems and on a sixth occasion while performing this StarClose procedure the patient started to scream it hurt them soo bad and he had to stop and finish with some other closure device! He also quit using this StarClose Device!

I was also told from a good source from another hospital that they have had soo many problems with The StarClose Device they elected to stop the use of it. Also I neglected to say that when my Cardiologist was doing this procedure he had a Rep. from StarClose instructing him how to insert this Device. I was a guinea pig. So the bottom line here is the Vascular Surgeon will not remove this piece of metal because he says the damage has been done and removing it will not stop my pain because as it is shot in it grabs whatever is around it, and it has grabbed my nerve cluster and has damage my body for life. Also he says it is a severely high risk to remove it because he may have to cut a small part of my artery out and repair it which could cause death because of this being your main artery. I am asking is there anyone out there having this same problem and what have you done? Also could all people having problems with StarClose come forward we need to get together and do something legally. Thank you!!!!
Jimmy, Pittsburgh, Pennsylvania, USA, October 18, 2006

• Annie from Maryland -- if you are still sore 3 months after your procedure, we would recommend seeing your interventional cardiologist. It may or may not be related to the angioseal (which should be absorbed by now). But have the doctor who did your stenting look at you rather than a regular GP because this soreness is specific to the femoral puncture and interventional docs know more about this. As for the bladder infection, that is not a side effect we've heard of. Let us know what you find out.

And Frustrated -- the Protege stent is a self-expanding stent (no balloon needed). As we've written before, we haven't heard of "fixing" an angioseal that migrated into the artery by putting in a stent. We have heard that vascular surgeons have had to operate to pull the collagen plug out, but there may be reasons for the way yours was done. Any cardiologists or vascular surgeons out there wish to comment?? If you are still worried, that's what second opinions are for. It's an odd situation where you went for an angiogram, and found out your coronary arteries were fine, but you wound up with a stent in your leg to fix a problem caused at the angiogram access site. In any case, a 7mm stent is very wide (2-3 times wider than a coronary stent) so the chances of any complications from reclosing etc., are very low.
Angioplasty.Org Staff, Angioplasty.Org, October 14, 2006

• Forum Editor - Thanks for your quick reply. Yes, I am positive a stent was used to hold the AngioSeal up against the inside of the artery wall; I spoke with my cardiologist a few days ago to confirm. They gave me a card to carry at all times stating the type of stent used (ev3 Protege GPS 6FR/.035" 7mm x 40mm). My concern is that since the AngioSeal is still inside my artery as opposed to outside where it is supposed to be, albeit "out of the way", I'm wondering if there are any possible complications with that in the future, especially once my body starts absorbing it in the next couple of months. Would you deem it advisable to get a second opinion? This is all so new to me. Most of the side effects have subsided, however, I still get a "pinched" nerve feeling on the inside of my thing occasionally, as well as a cold, tingly feeling in my toes when I sit for more than 10 mins., but no complete numbness. Again, many thanks for your time in replying.
Frustrated Patient, Ohio, USA, October 9, 2006

• Hi my name is Annie, and I am having the same problems with the angio seal. I had 3 stents put in July 6, 2006. And I am having pain in the groin area where the seal was put in. It is constantly sore. I don't know what I should do about it. I also had a bladder infection after this procedure and I am 66 years old and this is the first time I had ever had one. It has my nerves a wreck. Between this and the Plavix I don't know what to do anymore. Do you have any advice?
Annie, Parkton, Maryland, USA, October 6, 2006

• Don -- this was a figure quoted in a symposium sponsored by Abbott Vascular at last fall's TCT meeting. There is a specific study that was done (I think through the ACC and SCAI) and we'll try to get the details and link for you in a subsequent post.
Angioplasty.Org Staff, Angioplasty.Org, September 28, 2006

• Forum editor- you mention the complication rate for closure devices is roughly 3%. Where do the the Doctors or hospitals report the complications where this figure of 3% is derived from?
Don, New York, USA, September 28, 2006

• Dear Frustrated -- sorry to hear of your difficulties. Haven't heard of a stent being used to "fix" a problem with an angioseal. Are you sure it was a stent? Perhaps something else was being done to address a blockage. An angioseal is a collagen-based device which promotes blood-clotting. If it has entered the artery, a relatively rare complicaton, it usually has to be removed surgically. Please let the board know what happens at your followup. If you are not satisfied, you might want to talk to a vascular surgeon to get a second opinion.
Angioplasty.Org Staff, Angioplasty.Org, September 28, 2006

• I'm a 40 year old female. Due to an abnormal stress test, I had a heart cath. performed (right femoral artery) on Sept. 14, and an AngioSeal was used. We were thankful to find out that my stress test was a false negative result, and my heart was perfectly fine. I left the hospital with severe pains in my right leg hardly able to walk, and the nurse said there's a nerve that runs close to the artery and it may have been rubbed causing the pain. Three days later, I was losing circulation in my leg (numb, white, cold and not able to walk much). Day 4 I went back to my cardiologist and pulses in my foot which were still minimal. I was told there was blockage in the artery and they needed to do an immediate cath. through the left femoral artery to determine where and what was blocking it. So on Day 4, I went in for another cath. to find out the AngioSeal had shifted and blocked the artery. How is this possible if the collagen sponge is on the outside of the artery? The doctor apparently placed a stent in the artery (7mm x 40mm) to open it. If I understand correctly, the stent was used to push the seal up against the artery wall to open the blockage presumably until it dissolves. Is this normal instead of removing the seal? Are there any possible future complications with stents? After the second cath., they closed the artery the "old fashioned" way by applying pressure and laying in bed for 9 hrs. There was more bruising, etc., with the second procedure, and the entry site appears to be larger. Day 5 I was discharged from the hospital. I am taking 325mg. of aspirin a day, and I am having cramping, lower back pains which I didn't have with the first cath., as well as a low grade temp. on and off. Both legs are sore, and I occasionally get a "pinched nerve" feeling on the inside of my right thigh. Today is Day 8 after the initial heart cath., day 4 after the second cath., and I feel worse now then I did a week ago, and all of this to find out my heart was in good condition; very frustrating. One final thing I would like to add which makes me nervous. During the second cath., the doctor and two nurses had to stop to read the instructions on how to insert the stent as the hospital had ordered new/different ones. Would this make anyone else nervous, especially after having gone through what appears to me as a somewhat unnecessary second procedure? I think for the sake of their patient, this should've been done a little quieter or the instructions should've been read prior to surgery. I have a follow up appt. with my cardiologist in 30 days praying all goes well from here forward.
Frustrated Patient, Ohio, USA, September 22, 2006

• John -- we don't give medical advice on the Forum -- normally the puncture site with or without Angioseal should be healed a month after a cath, but this is a question you should ask your interventional cardiologist who would be more familiar with any specifics of your situation. Hope you have a good time with your grandkids.
Angioplasty.Org Staff, Angioplasty.Org, September 22, 2006

• How long after I have an angioseal inserted after a cath can I go swimming? I had mine done two weeks ago and my wife and I would like to take our grand children to a water park in two weeks and I know that they are expecting grandpa to be in the water with them.
John Stadelman, Manitowoc, Wisconsin, USA, September 20, 2006

• As someone who instructs both physicians and techs to use closure devices, I can say the only thing that differentiates their skill at using them is their attention to detail. Like knowing the limitations of the device. What you can and can't use it on. Also repetition with one device and not constantly changing from one type of device to another. All operators of Vessel Closure Devices are suppose to complete training with a representative of the device they choose to use.
P, USA, September 13, 2006

• Dear Forum Readers: beware of sock puppets! We occasionally get posts from "patients" whose enthusiasm for medical devices seems too good to be true. On more than one occasion we have traced the posters IP address back to a device company computer. A person posing as a member of a community in order to promote his business is known in web lingo as a "sockpuppet":

• I have personally had three cardiac cath procedures, one of which was a diagnostic procedure and the other two were interventions and stent placements. On all three procedures I had the pleasure of getting a Perclose Proglide device. I had no complications with this device. My groin area hardly even had any bruising! I felt some discomfort and mild pain during and immediately after the procedure but it subsided and I felt great! I am happy to say that I recommend Perclose to any patient needing a closure device after a cath procedure. My Doctor told me that Perclose was a more natural way to close the artery, using suture instead of a collagen plug which adds much more foreign body being implanted. I have many friends that have had the Angioseal device and they all have encountered problems.
Michael, Boston, Massachusetts, USA, September 9, 2006

• I am wondering if anyone has had problems with the Starclose after a heart cath? I did and boy am I angry! I ended up with a hematoma that was 13cm big and I had 4-6 units of blood! They then had to open me up, after waiting 4 days, to remove it. The one nurse said, as she was applying pressure to the cath site to stop the bleeding, that every time they use the Starclose, the patients end up bleeding. I just had this done on Aug 8,'06 and I am fighting off my infection to the surgery site. Please let me know if anyone else has had this problem!
Leslie, Whitehall, Wisconsin, USA, September 8, 2006

• I had a heart cath in March 2006 and the doctor had the scrub tech do the closure with a Perclose device. It was terribly painful and he pressed VERY hard for a few minutes. Ever since I have had pain in my groin and upper leg, numbness and tingling on top of my thigh and occasional electrical shock pain shooting down my leg. I have been to specialist and my tests are normal, no permanant damage that they can see and they tell me it will just take time, maybe up to 1 year. I am on Neurontin but it's not helping yet. I am really curious if it is the accepted thing to have the cardiac cath scrub tech deploy the closure device, and what kind of training should they have. The doctor made a point to tell me during the procedure that there was a study done and that it was found that the scrub techs were better at it than the doctors. What do you think about this?
Cindy K., Alaska, USA, September 8, 2006

• Michele -- the complication rate for closure devices is roughly around 3% -- and is comparable to manual compression. There's been some discussion in the medical community that the complications in either are mainly due to non-optimal punctures (done with a small needle). If the puncture has a problem (too high, too low, wrong angle, etc.) any closure method will be slightly compromised. Remember, 97 out of 100 patients have no complications. On a different topic, has your doctor considered a 64-slice CT angiogram instead of the standard cardiac catheterization? If your cardiologist is relatively sure you're going to need intervention (angioplasty or stent) then catheterization is the way to go, because they'll do the stent in the same session. But if you are considered "intermediate" risk for obstructive coronary disease, then the multislice CT scan should tell the story and is much less invasive. We're not advising you one way or the other -- just asking you to ask your physician why not do a 64-slice CT scan? Let us know the outcome.
Angioplasty.Org Staff, Angioplasty.Org, September 7, 2006

• I am a 39 yr old healthy female. I had a corpectomy with fusion to my neck. During the surgery they found a left bundle branch block on the EKG. I went to a cardiologist, had a heart monitor for 24hrs which showed just a few extra beats and a normal echo-then I had the non stress test with the nuke stuff. It came back positive. I am scheduled for my first angiogram on Sept. 21st and I am really scared and wondered what people think about the success rate of the angio seal? Also does everyone experience pain to the groin after and if so for how long. Any suggestions are much appreciated.
Michele, Ohio, USA, September 6, 2006

• Hi , am following up from a post I sent in April concerning my wife. Same problems, terrible pain from hematoma from angio seal. The hematoma she had finally went away, it took 3 months. She is doing fine now, had to take it very easy for the whole time and not go to work on bad days. Took Darvocet for pain worked OK. Went to follow up to doctor and tried to explain frustration, he seemed to brush us off, how sad. Just glad that it is better, sorry to see so much continued problems, I feel from my own research that some folks are having a reaction to the cow fat collagen that the seal is made from, maybe they can develop a test for the body reaction to these before it is installed. I know that my wife is very sensitive to chemicals and such. Good luck to all, and God Bless.
Arnold C., Texas, USA, September 2, 2006

• My family member underwent a heart cath. At the end of the procedure his doctor used the Cardiva Medical Boomerang Closurewire Vascular Closure System. When the cath lab recovery nurse removed the device she did not completely collapse the disc. When it was pulled from his thigh, naturally, he started to bleed A LOT! Instead of basically a 20 gauge hole in his artery it was about 7mm across. Has anyone else had problems with the disc not collapsing before the Boomerang Wire is removed? Thanks for your feedback.
Barbara S., Texas, USA, August 31, 2006

• J.S. -- Metal allergies and medical devices are a constant problem, which is why patients who are about to have any procedure involving an implant (like a stent) need to be aware of this and communicate it clearly to their doctor. Nitinol is a little more than half nickel. Whether the StarClose dev ice is causing your problem isn't clear. A metal allergy would probably take other forms -- have you ever experienced a reaction to metal, jewelry, etc? An allergist can confirm such an allergy with a patch test. As for the pain, this could also be a problem from the femoral access puncture itself and not necessarily the device. You also posted to the discussion on Nerve Damage and Complications from Angiograms. People in that topic have consulted neurologists, or neurosurgeons, since this is possibly a nerve-related problem.
Angioplasty.Org Staff, Angioplasty.Org, August 29, 2006

• Hello, I had an angioseal put in me on June 9th 2005 and since that time I have not been able to stand up for more than 3 to 4 hours at a time. Then I get pale, and sick at my stomach. Even after the 90 day period in which it was supposed to dissolve I'm still having this problem. Is anyone else out there having these same problems. If so I would like to know. Thanks.
Carey, New York, USA, August 28, 2006

• I had a cath (number 6) in March 2006 that was closed with Starclose, a nitinol clip. Other closures have not bothered me. I now have constant pain in my right leg and hip. Rheumatologist says it's not my joint. Also had terrible metallic taste constantly for about 3 weeks. Could this be a nickel sensitivity? Nickel poisoning? It's been several months and fatigue is a terrible problem as well. Anyone have similar problems? Thanks.
J.S., USA, August 28, 2006

• I was admitted to the hospital with chest pain and difficulty breathing, it was decided to do a heart cath. They did the next morning and closed the procedure with the angioseal sponge device. Thankfully, I had no damage, no heart attack and no blockages. They think it was a small blood clot from a previous knee surgery. I went home for my three day lay around and do nothing. On the fourth day I went to my regular doc to get my blood pressure meds refilled. While I was in the office, I felt a spasm go down the inner portion of my leg that brought me off the table for several minutes. The next day, I woke with fever, right leg pain and swollen. I had bleeding into my abdomen and that damaged my colon. I was admitted into the hospital, spent 11 days with DVT, ischemic colonitis and retroperitoneal hemmorage Anyone had this type of problem(s) and any advice?? Thanks Tim
Tim, Acworth, Georgia, USA, August 28, 2006

• The heart cath I had was May of 2005 -- it has been over a year and this is still present. I have searched the web for other people that might have had this swelling that has never gone away. My feeling is that something was wrong with the angioseal. I had a cath in 2003 with angioseal and all ok. The cardiologist told me he had never seen this happen before and he has done well over 5,000 catsh in his career. I contacted the maker of angioseal about the problem and they did not respond, so what am I to think? If anyone out there has had the same with the seal please post to this site so maybe we can get to the bottom of this. Thanks You can post my e-mail please -- it is ronnie_blackburn44@yahoo.com -- you have my permission. You can go to Google and ask who makes the angioseal and you will find warning letter from fda and what was found in a factory where these seals are made. I feel if this is found in one of the factories it could happen in other ones. Thanks. Ronnie
Ronnie Blackburn, Flatwoods, Kentucky, USA, August 24, 2006

• Ronnie, it's possible that your body is having a hypersensitive (allergic) reaction to the Angioseal -- which is bovine collagen-based. You mention a "bad bunch" -- do you know of some manufacturing problem? Also, you stated in a couple places your cath was in May 2005. Do you mean 2006?
Angioplasty.Org Staff, Angioplasty.Org, August 24, 2006

• Yes. I would like to put my two cents in on this swelling. I had a cath done on may 11 2005, and about two to three days later i noticed swelling below the cath site, this if about as big as my hand and looks like a big chunk of fat. Dr sent me for a doppler and a ct scan and report said it was adipose tissue and enlarged lymph node, i have seen other dr. and thay tell me thay just don't know. I think i was one of the ones that got one of the angio seals that was from a bad bunch. Please reply if anyone has same outcome. thanks
Ronnie Blackburn, Flatwoods, Kentucky, USA, August 23, 2006

• N.V. -- interesting that it has been determined the device is still there. I wonder if the process of bioasborption (which should be completing at this point) is somehow triggering an allergic or inflammatory reaction? Perhaps an immunologist might have an answer. Anyone out there want to chime in on this?
Angioplasty.Org Staff, Angioplasty.Org, August 23, 2006

• Device is still in place. My concern is why after 2 1/2 months after sudden pain in angioseal area, I now have swelling which appears to be soft and fluid filled.
N.V., Texas, USA, August 23, 2006

• N.V. -- had you any irregularities in that area in the time since your cath? According to manufacturer St. Jude Medical, the Angioseal collagen plug and bio-absorbable anchor are supposed to dissolve in 60-90 days. You're right in the middle of that period. Did the exams show any evidence that the device still is there?
Angioplasty.Org Staff, Angioplasty.Org, August 23, 2006

• 2 1/2 months after a heart cath procedure, I had sudden pain in area of angioseal and subsequent swelling of inner thigh area that looks like fluid under the skin. Doppler was negative for aneurysm or clots. Is this lymphatic in origin and cause for alarm?
N.V., Texas, USA, August 22, 2006

• I had my angiogram/angioplasties/stent emplacements done a month ago. They used an Angio Seal collagen plug for the right groin femoral site. I was required to remain laying flat for several hours, and to not move my right leg. Very difficult to remember ;) There was bruising and soreness at the site, and I had to avoid straining for a few days after my discharge, but three weeks after the procedures the bruises were entirely gone, all the soreness is gone, and you can't even tell anything was done there. I'm a believer!!
Kevin, Albuquerque, New Mexico, USA, August 10, 2006

• I had heart cath May 2005, and about 3-4 days later noticed swelling on the upper part of leg just below puncture site. When the Dr. was finishing up and removing the cath I felt a really warm sensation in the thigh and ask if I had a good rush of blood. The tech said it was contrast, and when he was putting in the angioseal I had like electric charges going down my leg. It is now August 5 2006 and i have a chunk of what is called adipose tissue about the size of my hand on the leg. Could this be caused by the seal they used? has anyone had this experience?
Ronnie Blackburn, Flatwoods, Kentucky, USA, August 5, 2006

• Alex -- do you know the name of "the balloon-type plug" you describe?
Angioplasty.Org Staff, Angioplasty.Org, July 20, 2006

• Well, now I know these are not anxiety pains like my cardiologist suggested! I had no idea so many others are experiencing the same symptoms. After my 3rd angioplasty I had severe bruising and tenderness from my groin up to my lower stomach that lasted at least 6 weeks. It's been 12 weeks since the procedure and now I have swelling at the groin area and sharp shooting pains that move from the groin to my lower back. My right leg aches practically all day long and my right foot swells from the ankle to the toes. The only relief I have is to recline and relax. Once I get up and start moving around, it starts all over again. I strongly feel this is some type of nerve damage. They used a balloon type plug to control the bleeding instead of pressure, I had no problems with the first 2 angioplasties where they used pressure instead of the plug. Could this plug have caused some damage to the nerve?
Alex, Bakersfield, California, USA, July 19, 2006

• Tony in NY, You are so wrong to think that any hospital or doctor uses these for monetary gain. The devices cost $150-$200 a piece plus extra time to insert in the cath lab. There is NO increased reimbursement to the hospital or cardiologist. The potential benefit is slightly decreased bed rest. My large cardiology group and my major hospital cath lab are not convinced that any of these devices are worth the risks and cost and we very rarely use them.
Maria Markarian, TCI, Lansing, Michigan, USA, July 18, 2006

• I had a coronary angiogram three days ago (July 4) -- had pressure wire test (luckily negative so not angina) sealed with a angio-seal. My groin is burning and have a small pea sized lump on the site. Is this normal? Cheryl, 47yrs old.
Cheryl Lygo, London, England, July 7, 2006

• I had an angiogram with the angioseal closure on May 31, 2006. No blockages were found. Everything went fine in the hospital and at home the next few days. But two weeks after the procedure my right leg, knee, ankle and foot have stayed swollen. I called the hospital where procedure was done and they said it could not have been from the angiogram/seal. I went to my regular physician and he sent me to have x-rays/ultrasounds done and there are no blockages in that leg or around the seal area either. The swelling stays but there is no pain or anything from it. Does anyone have any information or same experience as this that could inform me? Thank you.
Norma Smith, Somerset , California, USA, June 29, 2006

• Eleven days ago I underwent an cardiac angiogram that showed I had no arterial blockage. Without my knowledge my cardiologist used an AngioSeal to plug the hole in the artery. That night I awoke with intense pain in my groin and a bulge the size of a football. I was rushed to the ER and the doctor said she sees this all the time with these devices and that the hematoma would take weeks to subside. I still find it painful to walk and sit and lie in certain positions. I was on 81 mg of aspirin and I asked the cardiologist if I should stop taking aspirin 5 or 6 days before the procedure and he said no. The failure rate for these collagen devices are extremely understated. The nurses in the ER said they fail all the time. My cardiologist has never answered my call to him from the ER. He still had not contacted me. These devices need to be banned.
maurice bianchi, PVE, California, USA, June 26, 2006

• Had a Heart Cath and Stents put in June 20th. StarClose closure installed, I have a little tingling in my right thigh, and a small "hard spot" in my groin where the device was installed. I walked 1 mile yesterday and 2 today, was told no long walks for 2 days..waited 3...No leakage, sealed up pretty good, but, a little painfull right on the spot, about the same the last 3 days.
G., Ohio, USA, June 25, 2006

• David, you posted to a topic about vascular closure devices -- did you receive one of these?? You might want to read through the postings on a topic related to your problem: "Femoral nerve damage or other complications from angiogram or angioplasty".
Angioplasty.Org Staff, Angioplasty.Org, June 25, 2006

• I had a stent put in on June 16, 2006. They went through the femoral artery. I am having pain in my testicles. Is this common?
David, Arizona, USA, June 25, 2006

• Had my angiogram June 12, and got the angioseal. Had to use the bedpan afterwards and got a bad cramp in my leg. It took the nurse over 10 minutes to come back after putting on the call light, so I assumed all the aftereffects were from that. Went to the cardio on June 16 and was released to go back to work. I told him about the pain in my groin and upper leg, but he stated that there is a nerve that runs along the artery that sometimes gets irritated, and it will resolve itself. Went home Monday after working all day, and couldn't even think straight from the pain. Tuesday was a bit better, but today it's bad again. I can feel a golf ball size lump in my groin, and it is very tender. No heat, red streaks, etc... but I am concerned about this pain, especially after reading all of these comments. Oh, the angio was fine. Good strong heart. Guess I should be thankful, but it's hard when there is so much pain. I figured I would give it until Friday and then ask to see cardio if not improved. Now I'm wondering if I should wait or not.
Jeri Belcher, Porterville, California, USA, June 21, 2006

• Hello all. I am a 35 yr. old female. I had a stress test which told the local cardiologist that I had had a heart attack and then some blockage. So naturally I was nervous and upset. I was directed and admitted to Centennial Heart Center in Nashville. I do have to say that the cardiologist there was a very delightful woman, she was very sweet and pleasant and I would recommend her to anyone. I had the cardiac cath done and the site was sealed with the AngioSeal. I have my little card and all. But I had to go thru this all for nothing. There was nothing there, no blockages or anything, She said that she saw where I was very dry but nothing serious. Okay so that was good news, but now I am having all over body itching. I have very sensitive skin and it seems like every dermatological problem that I have has been aggravated. I was and still am wondering if it could be the device that is dissolving that is irritating me. I saw my dermatologist and he gave me a cortisone shot but I'm still itching. I have no clue what is going on. I just want some relief. If anyone can help me please advise. I am so tired of the itching. I have scratches all over my body and extra moisturization doesn't seem to help either.
Diane Johnson, Shelbyville, Tennessee, USA, June 20, 2006

• I have hip pain, I had an X-ray and it showed 3 surgical clips. My hospital record says that Perclose was used after one of 2 angiograms (but on the other side) in 2001. Sounds like my problems appeared about 6 years after the use of Perclose. The question is - can the Perclose device be removed and possibly improve the situation?
Mary F., Illinois, USA, June 19, 2006

• Mine is the same story I've read a couple of times. I had the procedure on 5/25/06 and one artery 90% blocked. Now I have a stent, but the groin site is my biggest problem. Still can't sit for any extended period of time. I did "bleed out" in recovery and still had the pressure applied. Didn't get the card saying I had an Angio Seal until 10 days out of the hospital. I went back to the Dr. and they did ultrasound and said no critical problem, would just take time for the pinched feeling and knot to go away. I read that some drs. said take it easy, mine only said to apply heat. I have since gone to new cardiologist who is monitoring it, but no real suggestions on how to improve my condition. I'm not overweight and had no physical problems before the procedure. It has been a nightmare and I'll try and report to FDA as your site mentioned in one of the posts.
J Thomas, Covington, Louisiana, USA, June 17, 2006

• hi, had an angioseal done mothers day weekend 2006 (about 3 weeks now) they told me about the angioseal briefly then was off to have my heart cathed. other then 4 ekgs that day (I had most heart attack symptoms) 3 came back fine, the 4th looked suspicious so despite asking for other less intrusive tests, they decided on a heart cath which showed a very healthy heart and no blockage at all. I seemed to tolerate the seal well for a week and was off work, but other things seem to be going on including all the same heart attack symptoms. after week one I went back to my dr who decided I has a heart infection.. costochindriatis... (sorry I cant spell worth a darn) and put me on nexium and aleve...which is not helping. now the groin area is starting to hurt, and the lower back, it feels like butterflies are are in my stomach all the time and im feeling nausea and hot flashes. i'm 44 and in great health other wise. he now says maybe an ulcer and wants to stick a tube down my throat, but after reading all these posts I think its more related to the seal! how do I get the dr to take me seriously? He is bent on trying to find other things wrong instead of what I have tried to tell him.
Su Sheldon, Arvada, Colorado, USA, June 6, 2006

• I had an angiogram and they used a cork almost 2 years ago. I have had pressure in my groin, thigh pain and foot numbness ever since. I had MRI all is fine. Had an EMG and it shows femoral nerve irritation. What can be done about this irritation after 2 years? Could the doctor have caused this? I also had an ultrasound and it showed swollen lymph nodes in the groin?? Can any one give help me. These doctors are no help.
Jennifer, Sterling Heights, Michigan, June 5, 2006

• I had an angiogram 4 years ago and an Angioseal device was used to seal the puncture site in my right groin. I do not remember being informed of this procedure before it was done. The results of my angiogram itself, was positive, however, I have experienced numbness, tingling and nerve pain intermittently in my right thigh and leg. I believe that too many people are experiencing continued pain from the use of Arterial Puncture Closing Devices to warrant its use. It is used as a convenience for the doctor, I believe and not at all for the sake of the patient. I am interested in knowing of any class action lawsuits.
Arly, California, USA, June 4, 2006

• I had a cardiac cath 2 weeks ago. I am still having significant pain in my groin area where the cardio-seal was deployed to keep from bleeding from the femoral artery. This was my second cardiac cath, the first, several years ago, with an external pressure method used. With the cath a few years ago, I had NO problems. With this cath, I am uncomfortable sitting on chairs, driving (now using the cruise control and putting the van in park, rather than leaving my foot on the brake at stop lights), uncomfortable sitting on computer chair, etc... This is just the beginning. I am having very painful bouts of burning pain in my lower groin, lower abdomen, at times all of the way up my abdomen, up to chest height, and sometimes through my back area with feelings of much pressure at times. It feels like the neuropathy I have in my feet. I am so disgusted. When the cardiologist told me about the cath risks, they never talked about any risks with using the Angio-Seal. They did not mention that the FDA has sent a letter in '05 to the maker of Angio-Seal regarding problems with some batches of the product. The doctor told me nothing about possible problems like I am now having. In fact, I was given the brochure regarding this closure device, and the card to carry in my wallet, AFTER I was out of the hospital bed and was dressing. It was not until a couple of nights later, when I was noting so much pain, I picked up the brochure and read it, cover to cover. The physician that used the seal on me also never inquired of me if I fit in any of the categories of people that they would not recommend using the Angio-Seal closure device on. I have read all of the posts on this site and formed the opinion that I do believe that many of us are suffering complications of being the "recipients" of this type of closure device. I really do hope that ALL of us with problems file with the FDA to tell them what it has done to our health/lives. Only if we contact them with enough numbers will a product be pulled from use. With regard to a couple of posts about how "wonderful" this device is. I would say, our opinions of the device would be determined by if we were in the percentage having complications, pain, interruption of our daily activities. I would like to hear more from those who have had the Angio-Seal removed and if most people continue to have problems, experience other complications from removal or if anyone is successful in having it removed and having the pain/problems go away. Has anyone experienced the burning pain, gnawing pain, in other areas that I have not mentioned?

My cath was clear, no coronary artery disease. What a price to pay for that information. It's too late to say, I wish I never would have had the cath done in the first place but if I did have it a second time, why didn't they just use an external pressure device? I would surely have not minded lying still longer and having no problems after the cath, like with my first one. The shorter time lying still is GREAT for the HOSPITAL, but I think our quality of life after the procedure should be more important. In retrospect, doesn't it seem that it is foolish to be introducing foreign objects into our ARTERIES... taking risks that shouldn't be taken? That is my opinion.
Sandy E., Wisconsin, USA, June 3, 2006

• I had an arteriogram done to determine the percentage of blockage in my right carotid artery. I was wondering what experiences others have had regarding the starclose device - specifically, did it hurt having it placed? I suffered a stroke as I was being moved from the table.
phyliss k., USA, May 29, 2006

• On March 24, 2005 I had an angiogram to find the blockage in my right femoral artery. They went in through the left groin, before the procedure I was told that when it was complete they would apply pressure for 15 min. and I would have to stay in bed for 6 hrs. But when I came to from the procedure they told me they used an AngioSeal and I would be able to leave the hospital in 2 hrs. Starting that day I had pain in my left leg after 5 days I could not take the pain anymore so I went to the ER of the Omaha V.A. Hospital and they rushed me into surgery to remove blood clots in what was my good leg before the angiogram. Now May 20, 2006 I still have severe pain from nerve damage which came from the surgery. I also got carpal tunnel syndrome while I was in the hospital because they left an IV in the same place for six days until it got infected. They told me they normally move the IV's every three days but I was "hard to stick". And I've been unable to work because of the medications I'm taking. The state employment agency told me to come back when I'm fully recovered. I wish I would've been given the option of saying no to the angioseal because on St. Jude's own web site under precaution it states the safety and effectiveness has not been established in patients with clinically significant peripheral vascular disease, and that was the reason I was to have the angiogram in the first place. Since it was done at the V.A. Hospital I can't even find a lawyer that will help me.
Terry M., Nebraska, USA, May 20, 2006

• I am a Vascular Surgeon and Vascular Interventionalist who has used both closure devices (Angioseal, Perclose) and manual pressure. For me it depends on the specific clinical situation and patient risk factors when deciding on a closure device or manual pressure. I would be happy to examine and assess any patient who has a concern with their symptoms after having a closure device. At times, removal of scar tissue around the site may help with pain and it would be prudent to make sure there is no harmful impingement on the artery.
J. Vasquez, MD, Surgical Associates of Dallas, Dallas, TX, USA, MD (jaquezgreen@hotmail.com) on Saturday, May 6, 2006

• Thank you for your assistance. The AbbottVascular site had the information I needed. Your site is a great resource!
Nellie Owen, Owensboro Medical Health System, Owensboro Kentucky, USA, May 5, 2006

• Nellie -- try the "For Medical Professionals" section of Abbott Vascular's site and look under "Improving Vascular Access Outcomes". There are several PDF documents that may answer some of your questions. Let us know if these were of help.
Angioplasty.Org Staff, Angioplasty.Org, May 2, 2006

• Wanting to find infomation about the clip used in the StarClose. I cannot find any information on the Abbott site about possible complications/discomfort from the clip. I am a nurse educator; one of our cardiologists recently began using the StarClose. Looking for information for teaching the nurses taking care of patients post-procedure. Thank you
Nellie Owen, Owensboro Medical Health System, Owensboro, Kentucky, USA, May 2, 2006

• Arnold -- we hate to read postings like this. Especially when a complication occurs AND there was no disease found. Diagnosis of coronary artery disease is changing -- the newer 64-slice CT scans are able to show blockages in a non-invasive way (no catheter). There is a not insignificant amount of radiation, but no more than if a catheterization was done. As for "staying still" 1-2 weeks after the cath and Angioseal -- the whole idea of Angioseal and related products is what's known as "early ambulation" -- the patient is supposed to be able to get up off the table and walk in only a few hours. It's actually the major benefit of using these collagen devices. Staying still for 1-2 weeks is not normal. It sounds like your wife suffered a complication -- for some reason the Angioseal did not seal the artery. First off, you should make sure this complication is reported to the FDA. You can read about how to do this here. It's not the most user-friendly method, and it sort of involves your doctor. But -- this sounds like a complication and should be reported. (We are concerned that many of these events do NOT get reported.) As for what to do now, it sounds like you have discussed the options with what sounds like a vascular surgeon (if not, see one!). We cannot give medical advice, but please let us know how things progress. It will help our readers.
Angioplasty.Org Staff, Angioplasty.Org, April 24, 2006

• Continued from previous post, wife had a terrible pain friday am tying shoe, stomach swelled, this is 3 weeks after angioseal,seems the vein opened,the original surgeon said buck up it is not from his work, duh!!!will give stronger pain meds. went to another surgeon this am, very nice, he explained that have 2 options , surgery, with 3 month recovery, or take it very easy and do nothing, let body heal itself , 3 month recovery, damn, wish the original doctor would have told us to stay still for at least 1 to 2 weeks after the original cath. No, he said go ahead and go back to work 3 days after , big mistake we feel. Never told us of the negative side effects. We just want honesty, and they seem to be only worried about turn and burn, make the big money. I know I am negative, and I am not the one in pain. I know there is an army of great doctors out there wanting to do the right thing. If you are one of them reading this, remember to tell us the good and bad before. Good luck to everyone here. If you have one done, stay still for as long as ya can. and may God Bless!
Arnold C., Texas, USA, April 24, 2006

• My wife had a Heart cath with the Angioseal 3 weeks ago, went home and she stayed down 2 days and litght 3rd day, night of third day had intense pin in groin area, next week constant pain, they said sometimes it take time . Went to family doc 9 days later, had hematoma in groin area, had CT scan, showed hematoma did ultrasound next day , no bleeding, hematoma is pushing on bladder causing urinary infection , took cipro and now infection gone, 3 weeks later hematoma still there, wife feels terrible, doc referring to Cart doc, options look like surgery to bleed hematoma or wait 3 to 4 months for body to absorb? don't know which way to go, she is feeling very bad and down. I know a surgeon will say hey lets go in, cart will say lets wait and see, please advise. She is 49 and has fibromyalgia also to complicate matters, the plumbing was clear, only good news from this. Thanks.
Arnold C., Texas, USA, April 20, 2006

• I had a cardiac catheterization on March 23, 2006 and they used the angioseal with out my knowledge or without discussion. Immediately after my procedure I had to lie still for four hours, after getting up and walking to the bath room I had this horrible pain in my leg, I brought this to the attention to the nurse that was supporting me, and I asked her why this was happening? she said that it was normal and that some people experience leg pain after this type of surgery. So she prepared the paper work and I was discharged to go home. After getting home my condition worsen so that I had to go to a doctor. My doctor informed me that Had some blockage in my leg because I didn't have very much circulation in my leg at all. my feet were ice cold and they would turn white any time I would walk on them. So she sent me to have an ultrasound and true enough I did have a blockage in my leg, after a second ultrasound and D.V.T. test which showed very little circulation in my leg I was immediately sent to have an angiogram done. They found that i did had a blockage. So the doctor did an angioplasty to try to remove the blockage but couldn't get the tube through the blockage, all the time my circulation to my lower extremities where getting worse, so the doctor kept trying to get through but he could not and caused some damage to my tissues, so he had to order emergency surgery right away.To make a long story short, I had to endure 6 hours of surgery to have the collagen removed from my main artery. The doctor had to cut three inches deep into my leg and cut a 7 inch slit down my leg. After the surgery, I had to lay flat of my back for three days, every time I came out from under sedation, I was put right back under. I was discharged from the hospital and I am still in extreme pain. There is also still the possibility that i may lose my leg if this surgery does not work out or they did not get all the collagen glue out. Reading all these other experiences of people having these same problems, why has nothing been done about this, or why there has not been a class action suit files in these cases. Keep me informed of any new developments. am glad I found this sight, I thought I was all alone in this.
Gloria F., Louisiana, USA, April 15, 2006

• I am a 30 yr old female and have had 2 angiograms. The first one was sealed using either the vaso seal or angio seal. ( I can't remember which one...sorry) That was in Nov. 05. I ended up needing an immediate quad bypass. Then Jan 16, 06 I suffered another heart attack due to 2 of my "new" arteries "collapsing". I had 3 stents inserted and that time they did the manual compression. I too had a much more difficult time with the "plug". However, I ended up having my chest carved up with a saw so I didn't pay much attention to my plug after that! But good luck healing and go for the law suit! I had a great law suit, but medical malpractice lawsuits in the state of FL are dropped 9 out of 10 times! Doctors should not be able to practice this way!!!
Niki B., Florida, USA, April 10, 2006

• I had a cath done on feb 14th and they used a angioseal to close the site! After 3wks I was awakened at midnite with a femoral bleed!! I mean a lot of blood. Had a ambulance ride of course stayed overnite had a doppler done saw a small leak in the site. following morning sent home! Was not home one hour and was returned again with another femoral bleed.The site has now closed, but I have extreme PAIN in the groin down to my knee. It's like a burning to stinging. I can not sleep very well. Anyone have anything like this?? Please help they tell me the pain will go away.This was one of four caths I have had done but this with the angioseal??? I have extreme pain. Any Ideas. Thank you.
Rich S., Pennsylvania, USA, March 30, 2006

• I had my 4th procedure on 3/9/06. I have had two angioplasties requiring 3 stents within the last 2 years and a follow up angiogram in 2005. All 3 procedures were uneventful and painless. They used direct manual pressure and 6 hour hospital stay except for the stents which requires overnight stays. My last procedure on 3/6/06 was a angiogram, did not require stents and the difference was they used the collagen angioseal this time without asking me or discussing it prior to the procedure. I noticed a difference immediately. While in the recovery room I was in severe pain and had to ask the nurse for pain medication in which they gave me tylenol which did nothing for the pain. They released me in 3 hours even though I was in pain. This was seven days ago and I have not returned back to work due to the pain. My groin is on fire, swollen, and I am begriming to exhibit signs of an infection - I feel hot and start sweating then I get the chills, swelling in the right side of the groin and that pain and burning sensation.

They sent me for a sonogram today, told me to ice my groin - 20 minutes on 20 minutes off, take anti inflammatory medication and put me on a strong oral antibiotic medication. The ice helps temporary then the pain and burning comes back. They told me to stay out of work for another week.

I did not have these problems for the last 3 procedures. It only started after the use of the angio seal. I do not recommend this procedure nor would I have it repeated in the future if I needed another procedure.

Based on all that I have been reading I am considering a law suit or class action suit if possible. How many more people should have to suffer due to this procedure? I believe the hospitals are doing it for monetary reasons: 1. They do not have to tie up a nurse for 20 minutes or more per patient. 2. The release you after 3 hours instead of the traditional 6 hours. More turn around time to get more patients in, that's twice the patients, twice the $$$$$ billing the insurance companies and the patient co pay. To me it sounds like greed and negligence on the part of the medical community. What does everyone else think??????
Tony, Mineola, NY, USA, March 14, 2006

• Hi, I am a 52 year old female that had a cerebral angiogram Jan 10,2001, a perclose procedure was done during the angiogram they disected my carotid artery so 6 months later I had to have another cerebral angiogram. Ever since the procedures I have had pain, a filling of fullness in my leg and numbness occasionally. Does this happen to anyone else and is it normal. I have told my MD but I am not sure if he knows all about the perclose procedure. The only info I have is the booklet the Doctor gave me at the time. All my records were destroyed at Methodist Hospital during a flood in Houston. So I can't get the information to my doctor. Anyone have any suggestions?
Sandy Presley, Houston Texas, March 07, 2006

• I had an angio-seal right groin last week on Sunday. On Monday morning, when I pushed while going to the bathroom, the seal apparently released and the area filled with blood. The nurse put pressure on it for 20 minutes and then asked me to lay still for a few hours. It appeared to have resolved itself. Since coming home on Wednesday, I have developed a swelled area running lateral that is about 2.5 inches long and about pencil sized. It is a bit tender to the touch. If I push on it firmly but gently I can feel the pulse and it shrinks in size. I don't know if pushing is good or bad and it's been devilish getting a response from the Cariologist. I have an appointment with my internist Wednesday morning, but would really appreciate knowing if I should be doing anything before that. Thanks.
Bill Noyes, Tucson, Arizona USA, March 06, 2006

• I had an angiogram done on 12-12-2005, and an angio-seal device was used. I went to the recovery room for 3 1/2 hours and was then sent home (37 miles in the country). When we got home, I was in such discomfort and had a swelling in my right groin the size of a grapefruit! My wife rushed me back into the emergency room, where I was diagnosed with a major hematoma. After the nurses put pressure on the site manually for 45 minutes, they then applied a sandbag, and I had to lay there in the ER for an additional 4 hours! I ended up with huge interstitial blood clots in the tissue surrounding the puncture site, and was bedridden until January 3rd, 2006! I am still in pain and still have some remnants of the clots ( I can feel them through the skin). It is now March 1st and I am in pain as I sit here and write this. To make matters worse, I am a Registered Pharmacy Technician and I also hold a license as a Repiratory Therapist. Both of my jobs require me to be on my feet from 8 to 12 or more hours a day...I am in agony by the time I get home!!! I quess the best thing that could be said about the whole thing is that my coronary arteries were clear as could be, but I'm not so sure the aftermath was worth the diagnosis
Ronald B. R., North Dakota, March 01, 2006

• Had another stent fitted recently and another angioseal device too, last time I got a swelling but it gradually went, this time the nurse spotted the swelling pretty quickly and just leaned on it for 20 minutes or so, I asked her what caused it and she explained that it was just blood getting into the surrounding tissues, but it needed to be pressed out and dispersed, later that day it swelled again, so I pressed it and it receded, I followed this practice for the next three or four days, pressing on the bubble till it reduced, and finally I pressed it so I could feel the angioseal quite plainly, and pressed either side of it to help close up any leaky spot inside. I kept the pressure on for about 20 minutes (hard to do, your fingers ache!) but it was a great success, and now all I have is the small lump from the seal. Obviously a large bruies too, but that's only to be expected what with the Heparin and the Clopidogrel and aspirin all thinning the blood.
Kim, Pembs UK, February 24, 2006

• Hello, I'm a Cardiovascular Technologist working in a cardiac cath lab. I've been doing these procedure for approx. 22 years. I've seen many revolutions in this industry but not many as significant as closure devices(Angio-Seal, Perclose, VasoSeal). Most complications I observe are from user error. There are distinct selection criteria which doctors and staff should observe. Many patients are not good candidates for closure devices. However, closure devices can be and are a great benefit to patients. Patients can ambulate within 2 hrs. and the likelihood of rebleed (when inserted properly) is less. The biggest limiting factor as far as I'm concerned is additional cost to the patient. Manual pressure is also associated with a list of possible complications including rebleeding, pseudoaneurysm, infection, blocked artery etc... Please be informed and educated on all your options so that you make the best choice for you.
David, February 20, 2006

• Hi. Happy to find this forum, but my heart (no pun intended) goes out to those who have had the horrid complications I've read about. Had a stent done 9 days ago, and was on my back for 18 hours with a pressure device at first and then a sandbag. I do not know if a closure device was used. There were no complications, except that there is an elongated hard lump (about 2-1/2 inches long and 3/4' in diameter in the groin. Its long axis parallels the artery. The cardiologist noticed when listening for blood flow before hospital discharge, and said that it sometimes happens. Maybe I got back to my usual routine too fast, but it has increased to the size described. There is no pain, although I know the lump is there. My black and blue marks are disappearing quickly. Seeing the cardiologist in a few days. I'm concerned about any need to miss work, as consequence of the lump. Let me offer my apologies in advance for asking a question about what might appear to be benign compared with what some contributors to this forum have experienced. Nonetheless, at 63, I cannot afford to have any doubts raised about my fitness to work (high level electronics consultant with too much responsibility). Thanks.
b.k., New Jersey, February 19, 2006

• I had a heart cath done on 1/23/06, and my cardiologist used the star close device. I was sent home after about four hours of observation. The next morning about 10:00 am, I started to feel somewhat light headed and started to feel a cold sweat coming on. To make a long story short, I was bleeding internally because the Star Close device failed ( according to my Cardiologist). After two days of touch and go, and six units of blood, I was finally stabilized. After six days in CCU, and two more days on the ward, I was released from the hospital on 1/31/06. I still have not returned to work yet, but I hope to on 1/27/06. I know the star close device is new here in the states, actually there were two representatives from Abbott, the manufacturer of the device in the Cath lab during the insertion of the device, to ensure it was done properly. Ask your Doctor if he is planning on using this device during your Cath, to make sure he has some experience with it before using it on you, it might just save your life!
B. D., Florida, February 17, 2006

• HI I am a 40-year-old female who had a heart cath 2 weeks ago, and an angioseal device fitted. I had paperback sized bruising and a fair amount of discomfort following the procedure. My worry is this: I have developed protruding veins on my lower right leg, as if I had strands of blue wire wrapped around my calf, this worsens on standing still/sitting.There is a slight degree of swelling. Is this a normal complication from either the cath. or the angioseal ? What can I do about it?
Lizzie, UK, February 16, 2006

• Hello, Had angio-seal put in June 9th St. Thomas hospital in Nashville, Tennessee. Doctor didn't tell me, or ask my permission. During procedure a man came in and started instructing the doctor how to do something. After it was over they told me what they did. I layed in ER for 6 hours made two trips back and was virtually bed ridden for months. Had ultrasounds, MRIs, and pain continues and I'm only able to stay up 4 to 5 hours at a time. Then I get pale, blood pressure drops and I get sick. Still suffering daily with aching in leg and pain in groin. Doctor that did this said she damaged my femoral nerve. Anyway, I'm currently in a lawsuit against her and the hospital as no informed consent was obtained or given by me. 8 months and still suffering. That's my story and I'll update you folks as things unfold. I wish everyone out there the best of luck in their troubles, and thankful for this website. We need to stop these things from happening to others. By the way my heart was fine.
Tennessee, February 11, 2006

• I am a 37 yr old woman and had an diagnostic angiogram done on 1-13-06. Angio Seal used even though forms provided to me at time of consult two days prior explain that manual compression will be used. Never heard of Angio Seal until it was being deployed into me. Unfortunately, it "Slipped" according to the Radiologist. Complete blockage to artery. They did ultrasound to right leg and another angio on left side routing to right leg to see damage. Left leg manually compressed and feels fine today except for bruising. They put me on heparin. Had to have it surgically removed that night, and a vein patch used to repair artery. Developed abdominal hematoma, blood count 8 post op. Lots of bruising to thighs and right thigh numbness. Difficulty walking. Today, four weeks later, still bruised, numb, belly still distended from blood. Now the bottom of the incision has opened and I have a hole there now I have to pack twice daily. This has been a nightmare. I feel violated and misled. If I had been told about the angio seal during my consult, I would've googled it and may have seen this forum or others out there. I would've prefered to have been flat on my back without a foreign body in my artery for four to six hours any day over what I had to deal with. As it turned out I was flat on my back for two plus days and in hospital for 5 days total. I understand what happened to me is rare and a risk associated with using the device, but I wasn't even aware of the risks as they are printed on the back of the pamphlet that was given to me after the procedure. I feel somewhat fortunate in that I never left the hospital or even stood up post procedure as they knew immediately there was a problem. My leg felt hot and heavy immediately and pulses in foot were extremely week if found at all. This has altered my and my family's life. I would still be upset if this had happened to me knowing an angio seal was to be used, but the hospitals own forms say manual compression. I feel taken advantage of and misled. Is the use of this device new to this hospital? Why isn't it disclosed? So many questions. I hope to find the answers. Good luck healing to all...
L.T., California, USA, February 10, 2006

• i had a angio seal last week...the night of the heart cath, i had a popping feeling in my upper thigh. i had excruiting pain and was sick to my stomach and passed out from the pain. my son called 911 they took me to er. where a sonogram was performed. it showed not blood clots or aneurysms...i have severe bruising from middle of my thigh around to my buttocks. my leg stays cold and it feels like it is asleep all the time. my cardiologist doesn't even want to see me anymore he told me to go to my family doctor. i am really worried as to what might happen next and why do we have to carry a card around with us for 90 days after the procedure. i am seriously considering seeking an attorney...i really dread seeing my hospital bills. anyone that has any info on this please email me (note: email addresses are no longer posted on this Forum to protect privacy and reduce spam -- if anyone posts a reply, it will be forwarded. Ed.)
lisa, accts, prestonsburg ky , February 06, 2006

• Gail -- definitely see your cardiologist, as this would seem to be related to the femoral insertion site done for the catheterization. He/she can test to see if there is a complication (happens in 3.5% of patients). Let us know what you find out.
Angioplasty.Org Staff, Angioplasty.Org, February 6, 2006

• I am a 47 year old with a rather extensive family history of heart attacks. I myself have rather high cholet. levels and have recently been experiencing some other symptoms suggesting blocked artieries in women. My doc. sent me for a cardiac cath. They didn't find any blockage but did discover a relatively common heart defect that was most likely the cause of my other symptoms. After the procedure they used an angio seal, prescribed a med. for the newly discovered heart defect and sent me on my way. One week after the procedure, I have developed an ever increasing lump above the insertion site. It is somewhat painful. I am a runner and did attempt to run about 6 days after the procedure. This was truly a bad idea since the bump seemed to increase its growth rate and now I am experiencing pain when I go up/down stairs as well as stabbing pains in the groin area. I now know that I need to see my doc. but would like some suggestions for what exactly to be asking. I have not EVER had any medical issues in the past and truly don't know where to begin with my questions to him. Help?
Gail J., Wisconsin, February 5, 2006

• Just to back up John's post from the patients view... my initial angiogram wound in my right femoral artery was closed with an AngioSeal; no problems. After my angioplasy, which was done on the right side, the cardiologist tried to fit an AngioSeal but couldn't. Apparently the artery on that side had a bit of a joggle in it, and the catheter couldn't get round it (the catheter for the stents was a more flexible). The cardiologist then used a "Fermastop" device to apply mechanical pressure to the site. This worked, but I spent a most uncomfortable four hours in Intensive Care, lying still with this thing strapped to my middle. The discomfort lasted for several weeks and the bruising much longer than that. So there are pros and cons to all these things, Regards
Eugene Molloy, Shropshire UK, January 29, 2006

• John, thanks for writing in. You are, of course, correct -- and as someone who works in a cath lab, you're giving us the "real world" experience -- which can certainly differ from the "ideal situation". Just a brief defense of my statement to Ray -- he had his procedures somewhere around 1996 and had a sandbag overnight, so I think it is probable that he may not have had a vascular closure device.

But you bring up a very important point -- one supported by a number of comments in this Forum topic -- many, if not most, patients have no idea if a vascular closure device is going to be used, or even what a vascular closure device is. So first off, there needs to be better education for patients (and professionals) -- some people have collagen sensitivities or allergies and need to know that collagen is a component of many vascular closure devices. When these devices were first marketed, the hope was that they would reduce "time to ambulation" and have a very real benefit for patients: removing the restriction of having to lay still on their backs for many hours with a compression sand bag strapped to them. This was, for most patients, the worst part of the procedure. There was also the hope that these devices would reduce complications in the femoral arterial puncture site. The first benefit is often realized and caths can now be done almost as an outpatient procedure (also due to the smaller catheter sizes now used). But complications from the femoral puncture have not changed much, and a recent conference I attended presented data that the problem is with the puncture itself. If the femoral stick is not done correctly (as you point out, too high, to the side, with too much peripheral disease) then a complication is likely to occur, regardless of whether manual compression or a collagen plug is used. Abbott has a new device just out, called StarClose, which doesn't use collagen, but a star-shaped "clip" -- it performed well in clinical studies -- it will be interesting to see how it fares in the "real world" of the cath lab. Any experience with this device?
Angioplasty.Org Staff, Angioplasty.Org, January 27, 2006

• I disagree with the Forum Editor's response on 12/3/05. Having a heavy weight (sandbag) placed on your groin does NOT mean that you did NOT get a mechanical closure device. What it means is, that the physician had some cause to be concerned about hematoma formation. Why did I get a sandbag? Does the physician lack confidence in the manual compression technique of the staff in the recovery area? Was the Angioseal poorly deployed? Did it fail? Was the femoral puncture in the SIDE of the artery? Was it a high stick? Does the patient have peripheral artery disease? Some physicians add the sandbag as a course of habit after every case. Most of these questions will remain unanswered. Your doctor does not want to tell you that he lacks either the necessary skills to successfully deploy these closure devices, or the discretionary prudence to defer to manual compression in situations where a mechanical closure device is contraindicated. That being said, there are many who are quite adept at it. But how is the patient to know?
John, cath lab employee, texas, January 25, 2006

• Thank you for the information. Since I posted, my husband has seen a vascular surgeon who said as you did that he felt this was a hemotoma or a "bruise." He told us they often see this and it usually goes away in six to eight weeks. It continues "oozing" but the substance turned clear and now yellow. The lump is smaller and less painful. The area around the spot that is oozing looks as though it has blistered and is starting to scab over. My husband says it seems better so we are just sitting tight. My husband is scheduled to go back to work Monday the 30th and his job requires that he be able to lift 150 lbs and carry an 80 pound ladder. I am thinking of faxing the Dr's and asking them if he is really ready for that. Thanks again, I have found this board very helpful and hope this information helps others.
Barbara, Florida, January 24, 2006

• Barbara -- the purple is probably what is known as a hematoma, a complication from a femoral puncture not achieving complete hemostasis (stopping of bleeding) aftyer a procedure. You refer to the "tissue or something protruding from the incision" -- was this observed by the vascular surgeon? Did he/she say what it was? Your comments and any followup info would be most helpful to readers of this topic. Let us know how you fared.
Angioplasty.Org Staff, Angioplasty.Org, January 22, 2006

• My husband had angiogram with stents placed and angioplasty performed 1/12/06. He is diabetic and this is his second procedure, both used angio-seal. First procedure was fine he was up and doing well in just a few days. This time he developed a large painful lump above the incision, which had seemed to close nicely. After the lump, approx 72 hours after the procedure he went very purple in the same area. The lump has continued to grow in size and pain. He had an ultrasound and was told it was a lymph node and to see his primary. Primary said "crap" and he was sent to a vacular surgeon, who said keep an eye on it. That was this morning, one week after the procedure. Well this afternoon the incision opened and the site was bleeding. Called the surgeon they said lay flat and apply pressure and go to the emergency room if blood starts gushing from the site. Can't apply too much pressure because it is very painful. But the bleeding seemed to stop now it is oozing continuously and there is some kind of tissue or something protruding from the incision. I am so nervous, concerned that he is going to bleed to death in the middle of the night so I will not be sleeping. If it has not stopped oozing by morning I am taking him to emergency, I don't care if they tell me to or not. I certainly hope non of this is because we have an HMO.
Barbara, January 19, 2006

• I was never told I would be receiving an angio seal, and was never asked if I had any problems with Collagen. I was fine after the procedure but starting 5 days afterward have numbness in right leg, traveling to my foot. Feels weird. I have called my Dr.
Cynthia Caleca, Crystal Lake, IL, January 19, 2006

• Had heart cath 05/05, this is the conclusions.
1 patent stent inserted 2000.
2 Non_significant coranary artery disease.
3 Normal L V function
4 Normal Hemodynamics.
Can someone explain what all this means in lay terms. Thanks P.s Had angio-seal and still have large chunk of fatty tissue on leg. no pain
ronnie, flatwoods, ky, January 9, 2006

• I received an AngioSeal following an angioplasty and two stents. The cardiac recovery team also placed a 10lb weight at the point of insertion. I had a two week recovery from the procedure--until swelling and bruising subsided. I thought I'd post this because maybe more patients should have weight compression in addition to the sealing devices.
T.F., January 06, 2006

• I had an angiogram done Sept. 12, 2005 I have had severe pain in groin and back on the right side where a VasoSeal device was used in plugging the artery. I first thought the pain in my back was a kidney stone attack but noticed it disappeared when I sat in a recliner with an ice pack to my back and a heating pad to the groin area. Also I would like to mention I have severe pain in my right knee that travels upward to my hip. There is a numbness with a burning pain like it is on fire and a painful feeling of pins and needles. I went to the Doctor and a sonogram was made four months later showing the silicone plug is still the same size as it was when the radiologist put it in. I was in the OR room when the Radiologist pulled out a clip board and ask me to sign because they were going to use a new procedure The only thing I was ask was if I was allergic to latex or silicone. I told him I didn't know! My Cardiologist has made me an appointment with a Vascular Surgeon and I have been told it may be removed. I have always been very active. I need to exercise everyday as I had triple by-pass surgery eight years ago and have been faithful to exercise everyday, but now I can't even walk for any distance at all. I was told by the Radiologist and other Doctors that they have never run across anything like this before. I don't think they are telling us the truth. Someone is responsible for not being truthful to us from the begriming. I know I never had this pain before I had the implant. I want some answers and I intend to get them one way or the other. Thanks for letting me let off steam. Pat darty
Pat Darty, Jacksonville, Fl America, January 05, 2006

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