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Angio-Seal, StarClose and Vascular Access and Closure Devices (2004 and earlier)

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This is the archive of questions and comments about vascular closure devices, like AngioSeal, StarClose, VasoSeal, Perclose, Syvek, etc. from 2004 and earlier.

Other postings can be found here: Current, 2010, 2009, 2008, 2007, 2006, 2005.

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Archived Postings from 2004 and Earlier on This Page (72):

• What is the treatment for hematoma at the sheath entry site? Would ultra sound be safe to treat a painfull hematoma?
Hugh Dooley-Phillips, Private Physiotherapist, County Cork, Eire, November 23, 2004

• Please take these Perclose things off the market. My mother had a cardiac stent placement in May of 04 at a respected teaching hospital. Within 24 hours she was in emergency surgery repairing a massive retroperitoneal hemorrhage. Due to the many complications because of this hemorrhagic episode: stroke, seizure, respiratory arrest, anoxic brain damage, she had a five month long hospitalization and passed away in November. She will be missed by many. I pray that no one else will have to suffer by this medical practice which seems to have proven itself to not be the safest choice.
E. Rankin, New Hampshire, USA, November 22, 2004

• I am a procedural cardiologist, and ended up having an angioseal deployed on myself after a cath (by another expert cardiologist). My observation is that, this is still experimental, with inadequate post market surveillance, unpredictably high complication rate with dreadful consequences. Vascular closure devices are a convenience (more to the medical practice than the patient) rather than essential medical devices, and the profession can do with out them. I would never use it on my patients.
Simon, Australia, November 20, 2004

• My father recently had cardiac cath and angioplasty and angioseal was utilized. He is now complaining of "charly horse" type pain while walking which does eventually work out. This concerns me after reading all the complications. Does it begin this way and progress or will this be the extent of it? A card is given to the patient to carry for 90 days, does that mean he has the potential for complications for that 90 days? When reading the information given to him, it did not say anything about this type of symptom. Where do you go from here?
S. Williams, Marietta, Georgia, USA, November 11, 2004

• I had a cardiac cath with stent placed in the OM1 on July 19th. An angio-seal closed the wound site in my right groin. August 3th I went back to my doctor because my right leg was swollen and double the size of my left leg. I was sent for an emergency vascular Doppler on my right groin and leg. They were looking for a dvt. The collagen site was supposde to be the size of a pea. However, it was been the size of a quarter. Today, 3 weeks later, it is the size of a dime. The wound site remains sore to touch. Can I help this plug dissolve?
Betsy Hailey, Hospital, Allen Park, Michigan 48101, USA, August 08, 2004

• I am a 35 year old pediatric respiratory therapist. I tore both of my carotid arteries and required stents. Following the first of 3 angiograms, I developed a large retroperitoneal bleed. It was the worst pain of my life...worse than the headache of the impending stroke. A femstop was used. I complained of excrutiating pain for 6 hours and finally they did a CT and found the bleed. Now 8 months later I have horrible hip pain and I can hardly walk or stand or sit or lay down. I had a wonderful life before my injury now I am in pain 24/7 cannot sleep. Neurontin helped but they took me off of it because of some safety concerns. Does anyone have any suggestions.
Julie, currently disabled RRT, Dallas, Texas, USA, August 01, 2004

• How does a person go about filing a class action suit against Perclose? My husband had severe complications with the device and ended up with staph infection in his groin which spread to his chest. He was in the hospital for 5 weeks. Please help. We have talked to many lawyers and none want to take on a staph infection case.
E. Robinson, Burrton, Kansas, USA, July 26, 2004

• My wife had an angioplasty done using Perclose and has had groin pain since (10 months). Tests show no problems to artery, but she has pain even sitting let alone walking. Maybe if enough people complain, something will be done to find out why this device can cause such pain.
Kevin Gallagher, Emigrant, Montana, USA, July 09, 2004

• I am looking for thoughts on the Syvek Patch. I have an opportunity to sell it as a Representative of the Company who makes it (Marine Polymer Technologies) ANY thoughts would be great!
Eric Diello, Pharmaceutical Industry, Seattle, Washington, USA, July 09, 2004

• I am looking for guidance in returning to exercise. I recently had an arteriogram to investigate possible valve problems. The cardiologist used the Angio-Seal device. I had minimal bruising and almost no pain. The cardiologist told me I could return to my running and biking (normal routine) after a week. I am concerned about damaging the device or even having it come apart due to the stresses of exercise. Can anyone share any experiences or studies to relieve my worries? Send me e-mail with Angio-Seal in the subject line.Thank you.
Jim Hamlin, Birmingham, Alabama, USA, July 08, 2004

• I had a angio-seal put in last week after a angioplasty and so far I have had no problems unlike 2 months ago when I had a angiogram and developed a huge hematoma. I ended up being in bed for a month with severe pains. Also looking to hearing from anybody who had a femoro bypass that failed.
Silvano, Mississauga, Ontario, Canada, June 24, 2004

• I had 3 stents implanted on Feb.18,2004. In March I had more chest pains, they did another catheterization and found 80% blockage in one of the stents.This time they used the perclose device afterwards "because it is less painful and you can begin walking in 1 hour". I just about jumped off the table. It felt like someone kicked me in the groin. I had pain from my waist down into the groin and down the inside of my right leg to my knee. It was horrible. The next day I had brachytherapy and I wouldn't let them do the perclose procedure again. One of the assistants from the day before told me while I was in Pre-op that he thought the problem was the delay in doing the perclose (they were going to do the brachytherapy then, but didn't have a radiologist). I'd rather lay on my back clamped to my bed for 8 hours than go through that pain. I was sore and achy for about a 4 days and still have a small lump at the site. I feel much better now but am leery of this perclose procedure. It was anything but painless for me.
Joe Budwit, Addison, Michigan, USA, 30 Apr 2004

• Found this site quite by accident! I had an angiogram last november and still have hip pain. Iam beginning to wonder if there could be some nerve damage that i never even knew existed due to the angioseal??????
Anonymous, W. Midlands, England, 29 Apr 2004

• I had a heart cath done March3, 2004 and sealed with Perclose. I had pain right away. I have had three ultra sounds done on my leg, no problems found. Doc says "he's not concerned". Well, I am! I am always in some type of pain. At times it's like my leg and groin are on fire. I get a pinching or stabbing pain at times, tingeling and numbness too. I don't know where to turn. My Doc. never discussed using Perclose, I didn't know I had a choice or that it could be dangerous.
Linda Swogger, Waynesburg, Ohio, USA, 28 Apr 2004

• This is starting to make me wonder too! I had a heart cath done the first part of March, then about 3 weeks after, I started to feel pain in the area of the angioseal, pain like I had when I was released. Then just out of the blue I had extreme lower back pain and leg pain and have suffered from a numb right leg and foot. I feel very clumbsy now because I can not judge where my foot is taking me a lot of the time. If I should be on my feet for any length of time, my foot and leg will start to swell, and be painful. It has left me with a constant cold feeling in those areas, along with pain in my groin area if I should sit up straight, I am awaiting an apt with my doctor.
Tonja, Maryland, USA, 18 Apr 2004

• My mother had a Cardiac Cath procedure in July 2003. The doctor used the angioseal but it failed. She developed a hemotoma in her groin. As soon as she returned to her room ahe was complaining of pain and nausea. The Femstop was applied and she continued to complain about severe back pain. Her blood pressure dropped but it came back up with IV fluids. Her blood pressure dropped again and she was in extreme pain. The doctors kept telling us that this was normal. I knew that she was too uncomfortable for this to be normal. Four hour after the procedure, an EKG was performed. They had planned on doing a pelvic scan but it was too late. They were rushing her to ICU to monitor her. She passed away 2 Hours later. I believe she was bleeding internally the whols time. Could the bleeding have been stopped if something was attempted sooner? Please, if anyone has had a similar experience, could you respond.
Francine Orsini, North Haledon, New Jersey, USA, 05 Mar 2004

• My mother had an angioplasty and stent procedure in mid January. She has had severe nerve pain in her right foot and leg with numbness. The doctor used a collagen plug. Could that be the problem? The doctors say they've never heard of such a thing, but after viewing all the other comments, I am beginning to wonder.???????
Gayne, 11 Feb 2004

• Husband had Angio-sealed w/ VasoSeal- but seal "did not work". I suspect the sheath broke or seal was dislodged or some other complication(an hour is not accounted for...). no swelling or pain at the site; but, he has had intestinal gas ever since. Anybody have any ideas?? Also, he has lost about 5 pounds in 4 weeks -with no change in diet.
Susie Morgan, Pike Township Fire Dept, Indianapolis, Indiana, USA, 09 Feb 2004

• hi-i am a 58 year old male --i had an emergency angioplasty with a medicated stent to reopen an artery that had closed witout warning or symptoms after a previous angioplasty 16 years previous(same artery,different spot)--the first angioplasty was closed by the sandbag and direct pressure method (1986) with no complications---the new angioplasty(2003) was closed with the angio seal and i almost bled to death--even had the same doctor who did the first one do the second angioplasty--while in the CCU unit about 2 hours after the operation the nurse was routinely checking the entry site and told me there was a problem---they called in an army of doctors and nurses and told me that the angio seal was not working properly and i was bleeding internally into my body cavities (im not a dr. so please excuse my terminology)--at the time i felt nothing and would have bled to death had they not put me in the CCU and checked me--my whole groin area and right thigh and buttocks were filling with blood---it took them 7 hours total to stop the bleeding--they used direct hand pressure (2 doctors) and a fem stop later on after vascular surgeons looked at it---also had to get transfusions and a shot of atropine when i started to go unconscious --it worked out ok in the end with no complications except a gigantic hematoma for about a month afterward---if i had been sent home after the procedure,as some other hospitals do, i believe i would have bled to death, so i am thankful that this well known hospitals policy is to keep you in CCU to make sure you are ok before being released----i was released after 3 days in the CCU
robert cabano, retired electrician, North Babylon, NY, USA, 09 Feb 2004

• While there are complications with any medical procedures, we have been getting a number of queries about "femoral closure devices". I would point readers to this article posted on our NEWS site, published today in the Journal of the American Medical Associationon which questions the effectiveness of this device group.
Angioplasty.Org Staff, Angioplasty.Org, U.S.A., 21 Jan 2004

• Would it be possible to have Doreen from Los Gatos CA email me as I have the exact severe trouble that she has from the perclose insertion. Perhaps we can help each other as there is very little help to be found. Your assistance is greatly needed. Thanks! Chuck Vostry chuckv9721@aol.com
Chuck Vostry, Bolingbrook, Illinois 60440, USA, 11 Jan 2004

• I would like to know if anyone has found a treatment for the damage caused to the nerve in the leg after femoral artery angioplasty three months now and it is getting worse will I lose ability to walk??
Larry Oliver Sr, Windham Ohio, USA, 28 Dec 2003

• I also went through an angiogram, and when they closed the site they used a plug of some sort. The plug was supposed to stop the bleeding faster I am told, but what happened is much worse. The plug was pushed into the femoral artery causing blockage to the right leg. A week later after pushing my way into the doctors office because angio's never go wrong. I was on my way to surgery to remove the blockage. Now I have constant deep aching in the right leg, numbness and burning sensations. The right leg and foot seem to be shrinking up also. The surgery was done in april 2001, Could the leg be suffering from no blood for a week still, or did the nerve get damaged in the surgery, or could it be from all of those? This is keeping me from working as the lack of sleep is the worst thing besides the pain and burning. Would love to hear from anyone with some light on this problem.
Allen Thomas, Fresno, California, USA, 18 Dec 2003
 
• I had an angioplasty done in 10-15 2003 now have extreme pain in right leg. It felt like he was sewing up a nerve end when he did the perclose -- almost jumped off table. Is this rare or common when does extreme pain in thigh go away?? Should I sue perclose for this??
Larry Oliver, 24 Nov 2003

• Had my angiogram 6 days ago with angioseal, and am still in severe pain just above and medial to the puncture site. Leg is very numb. No redness, just a small bruise. Started swelling 2 days after procedure, now swelling is 3 inches down inner thigh and continuing. 2 days ago went back in and had an ultrasound that showed swollen lymph glands. The doctor said he's never seen anything like this and they don't know what to do, except keep taking antibiotics they gave me. Could be a reaction to the collagen, or maybe infection. But I had this pain immediately after the procedure. Feels like something is stabbing me, even when I'm lying still. This website has helpful info I will give to the docs tomorrow. Thank you.
Barbara, Torrance, California, USA, 03 Nov 2003

• Please, I'm begging you people to please look into a class action lawsuit into this perclose device.My father had such bad complications; staph infection, femoral blockage; his chest split open from such a terrible infection that he almost died. This closure is not safe!!!! If it was, why do so many people complain about pain?????!!!!
Shelley Armstrong, , Wichita, Kansas,USA, 08 Oct 2003

• My husband had a coronary catherization with brachytherapy. They used the left femoral artery site. Since the catherizaton he has experienced a numbness area and burning sensation paralel down his left leg. The procedure was done Aug. 19,2003. We were wondering if anyone has experieced this same problem and what was done about it.
Lora Jefferson, Pickens, SC, USA, 23 Aug 2003

• I had an angiogram on April 1, 2001. They used the collagen plug and it blocked the femoral artery. I had intense pain following the angiogram and insisted on being seen, seven days later I was given an ultrasound of the right leg and they found it had no blood flow. The following day they did emergency surgery to remove the plug that was blocking the artery. Now the leg is shrinking and I have intense pain all the time. It feels like my ankle is sprained, and it is very weak. The inside of the thigh is numb and all the muscles are mushy. I also am interested in a lawsuit as I am now unable to work. Please let me know if any others have had this same thing happen.
Allen, USA, 18 Jul 2003

• Any opinions on the Syvek Patch closure device. Seems like a great concept, but my concern is whether or not the results are as optimistic. Has anybody realized any benefits from using this product, i.e. shorter compression time, higher patient throughput, increased patient comfort? Any info would be great.
Christy, Japan, 07 Jul 2003

• What are the pros and cons of a Chito seal?
Andrew Nelson, Albuquerque, New Mexico, USA, 22 Jun 2003

• I had an Angio-seal on 5/22/03 , here it is a week later and i have a large knot in my groin area and when i sit and get up i have a pulling that is nagging (not really painfull) but bothersome. Also I can't seem to digest my food; it stops in my chest. Should i be concern?
diane walker, Brooklyn New York, USA, 08 Jun 2003

• I had an angiogram approx. 3yrs. ago and I am having pain in my groin now and numbness in my leg, and until now I didn't know what it was. I am so thankfull to this site. I have a knot in my groin and had a perclose plug becuse they told me I could get up sooner, but I had alot of pain for days and alot of bleeding, however I didn't know what was right. I don't know what this extreme pain is now , but this site gives me something to tell my doctor about, or at least what to look for, and it gives me hope.
Doreen, Los Gatos, CA, USA, 29 Apr 2003

• I had an angiogram yesterday with a Perclose closure. This was a painful procedure to such an extent that it made the shorter time in the hospital negligible. I suggested to the doctor that some form of anesthesia be used before closure, similar to the anesthesia used in a colonoscopy, and he said that it should be looked into.
George O'Brien, Westchester, New York, USA, 23 Apr 2003

• In September 1966 I underwent angioplasty successfully. The surgeon who performed it then fitted me with a femstop and took off. I have no way of knowing what his instructions to staff were, but within an hour after placement of the femstop, my leg went numb, and then became extremely painful at the site. Since I had been advised not to move, I began to loudly ask for help but no one came. I finally began yelling and sobbing uncontrollably because this was the most unbearable pain I had ever experienced, much worse than my heart attack. A nurse came and took the femstop off. The pain was similar to what you get with a pinched nerve, but of course there was no way to adjust my position to lessen it. This site was very painful for almost a week, and I had a difficult time walking on this (Left) leg. My wife and I would call the hospital (VA) and get a very ho-hum respose. I finally had to go back to classes (I was in grad school at the time) but decided to drop out for that semester because I would develop a tremendous ache or cramp in the underside of my left leg that made it impossible for me to sit at a desk for any length of time. If I got up and walked around it would seem to go away for awhile. I took the doctors advice and began to run and walk for health reasons, but since then have had left hamstring problems, left plantar fasciitis, left achilles tendon problems, and now I can't lay on my left side in bed, or sit at my office desk chair for very long periods. It is as if the nerve damage (or whatever it is) makes my left leg unable to heal from injuries, and the muscles and tendons are all atrophying slowly. I can no longer run wtihout great pain in my left hip, and the cramping ache in my left leg right under the hip is occurring right now, as usual, the cause of a very poor nights' sleep. I doubt if I have anyone I can turn to, because this happened in the VA. But I am wondering if I will be crippled now for the rest of my life.
Tom Smith, Iowa City, Iowa, USA, 09 Mar 2003

• I am an attorney investigating a case involving a 50 yofm with no other significant health problems who had an Angioseal after angiography. Almost immediately after her leg was painful cold and numb. With heparin her condition improved but 3 days later she had a complete RFA occlusion requiring extensive surgeries thereafter. Is anyone aware of any reputable studies which conclude these devices may not safe for low risk patients?
SW Burrows, Orland Park, Ill, USA, 6 Mar 2003

• I had a cath and stent a month ago. The doctor closed my leg with the Perclose device. It was quick and easy. I not only was up and walking in 30 minutes, but I left the hospital that night. My groin was sore for about a week and a half, but it was worse on previous procedures when I had just pressure held. My mother had the angioseal device and she had a major infection with it. I think that the people on this site arent aware that many of the complications that they are talking about can occur with any method the physician uses to close our leg. When I asked my doctor about the complication rates, he showed me studies which proved that the perclose device had lower complication rates than manual compression even. My results were enough to convince me.
Janet Wingate, 03 Feb 2003

• After angioplasty with stent insertion on Dec.8, the hospital used the AngioSeal closure system on me. It was 7 hrs before they got the bleeding to stop. 12 hrs later they had me walk the hall a few times, then sent me home (was day after procedure). That night, the site started hurting considerably and I ran a fever of 99.7 (my normal is 97.3). I called an on-call Dr., who told me to lie flat as much as possible for 2 or 3 days & go to em if my fever went over 100. The fever waivered from 99 to 99.7 for next couple days, then went to 98's for about a week. The site continued to hurt a lot, with mild swelling & small lump (about quarter size). The fever finally went away after about 10 days. So did the swelling & lump, but the site continues to hurt, & the front upper leg hurts. Cold & damp seem to make it worse. I've tried darvocet & extra strength acetaminophen (2) (obviously not together), but neither works. Why would I have this reaction? And is my only solution to wait the 90 days until the seal completely dissolves? Also, my Doctors have told me that I have very small vessels (like an 8 to 10 yr. olds). I'm an adult female. Thank you for any info. you can give me. I haven't really found any information about the seal itself.
Carol Turner, Blanchester, Ohio, 31 Dec 2002

• Donna Hoskin, R.N. Would like to talk regarding your ileoinquinal nerve damage. In same boat exactly as you. Am looking for suggestions how to cope with 18 months of pain. Nothing works. Can anyone help.
Brenda White, , Winnipeg, Canada, 27 Nov 2002

• This is a very interesting site. I'm a RN and experienced CHEST pain approx. 1 month ago. I had a CARDIAC Cath and bleed internally after I went home and have had severe pain and now have continual numbness in my leg and foot. The doctors are ignoring this and I have not been provided any information until now. Any further information on nerve damage from femoral site, I would appreciate. Also to respond to the question re: cath site pain there is pain/soreness up to 2 weeks beyond that and there could be a problem.
Debra Swan RN, , Nashotah, Wisconsin, USA, 23 Oct 2002

• I am thinking about a law suit, are you? The perclose devices have a lot of problems. Last July, I also had a perclose on my right femoral artery, and after I had severe leg pains, and went to the emergency room. There my artery burst from a staph infection, and I had major reconstructive surgery, leaving me in the hospital for a month. Today, over a year later, I have retired from work, because I now have a bum leg. My leg swells after a couple of hours on it. No one can tell me what to do for reimbursment for my pain. Sincerely, Larry
Larry Ney, Provo, Utah, USA, 11 Oct 2002

• I had a cath in 1992, and 3 more in 1999 (two were electrophysiology studies); AngioSeal was used on all 3 1999 procedures, without complications and much reduced discomfort. Remember, patient discomfort comes from many sources: the blood vessel penetrations; enforced bed immobility; possible intravascular coagulation at points other than the penetrations. My personal experience with AngioSeal was VERY POSITIVE. I was ambulatory faster; able to imput more fluid (and walk to the bathroom to get rid of them (an important point in encouraging fluid intake; and did not have one of the cath labs tied up as long.
Paul W. Antrim, Yorktown, Indiana, USA, 24 Sep 2002

• I had a angioplasty on 6\15\01 on 6\24\01 I went to the emergency room with a temp of 103.7 and pain in my right leg. On 6\28\01 I was rushed to the OR for emergency surgery. I had staph infection and perclose foreign material in my femoral artery. My right leg got a lot of blood clots and is had to walk on to this day. Has anyone had trouble with perclose and staph infection.
Larry Ney, , Provo, Utah, USA, 11 Sep 2002

• I had an angiogram 1 week ago and am experiencing constant cramping in the groin area. Have others had similar experiences?
Lisa Goldman, Woodbridge, California, USA, 15 Aug 2002

• My Mother had an angiogram on a Friday. An AngioSeal was used on the femoral artery. On the following Tuesday a doctor did an angioplasty. In the AngioSeal material it states that you or the patient should not have surgery at the same site for 90 days as that it how long it takes for the AngioSeal components to dissolve. After the angioplasty on Tuesday, my mother told the staff, as they were wheeling her to her room that she was bleeding inside. She had bled internally before from a ruptured ovary and so she knew the symptoms and what it feels like. They took her back up to the recovery room or cath lab and applied a Femstop. She had a visible 10cm hematoma on her right lower abdomen wall. The femstop was removed approximately 6 hours later. The hematoma had softened and so had her stomach area. She said she was still bleeding, and that her back hurt really bad. She asked me not to let them put "anymore" air into her.Her pain was not controlled by the morphine alone. Her body temp remained at 93 degrees, her stats were labile and she minimum urine output. Next morning still complaining of pain, nauseua, could not eat, said the food was getting caught and she could not swallow. She continued to deteriorate. Finally at 4pm when my mother's resps were up to 55 per min, and she was holding her arms over her head as she had previusly done during the day, the nurse got an order for emergency surgery. The cardiologist told the surgeon to check for mesenteric rents, bleeding in her upper and lower GI. He found nothing remarkable, but my mother had stabilized for the moment as she had been given more blood. At no time did any doctor look for vascular bleeds other than the one at the fem site. My mother, died of hypovolemic shock on Thursday, the county coroner found an AngioSeal anchor in her right common iliac artery. There were two defects/lacerations and the AngioSeal anchor prong was caught in one of the two lacerations. The unofficial word is that the guide wire from the angioplasty caught the AngioSeal anchor and pushed it up into the iliac area. Has anyone any knowledge of a fem site, that already contained an Angioseal, being used in less than 90 days or as soon as 5 days for angioplasty thru the same site with another AngioSeal being placed in the same artery? There was no emergency in doing this second angioplasty. Thank you
Francine Van Divier, , Monarch Beach, California, USA, 7 Jun 2002

• Has anyone seen a clinical study on the Syvek patch?
Thomas Morgan, Birmingham, Alabama, USA, 20 May 2002

• I would like to inquire as to potential of femerol obstruction after PTCA. My mother had stents, and femoral closure with Perclose. Leg became pale, severe pain. Turns out that femoral site had obstructed "closure was too tight?" Does this make sense, and are there other instances of similar complications?
Cathy Nearhoof, Integrist Healthcare Consulting, Pittsburgh, Pennsylvania, USA, 20 May 2002

• I had a heart Cath 3 days ago and my doctor used the Perclose technique. I am still experiencing pain in my groin and up my lower abdomen. Is this normal?
TVanDyke, Tennessee, USA, 13 May 2002

• Looking for detailed information on placement procedure for AngioSeal. What is the function of the "tampon tube"(?), and at what point is it removed?
Michael Shannon, Bryan, Ohio, USA, 11 May 2002

• I had a Perclose closing of the right femoral artery on March 28, 2002. The next day I had very nasty pains and severe weakness in my right leg (right femoral angiogram). These pains now continue upon exercise of that leg and also at rest. The following week I had a IDPV (doppler scan) which showed a 375 cm/sec. blood flow in my right femoral artery at the insertion site of the angiogram. On April 18. 2002 another angiogram (left femoral insertion) was performed to investigate the trouble with the closure of the right artery. Nothing of value could be seen according to my Dr. Today May 3, 2002, I had another IDPV Doppler Scan which now shows blood flow in the right fermoral insertion site to be 260 cm/sec. Can anyone tell me what happened to my once healthy artery? Will this get better than it is now and how can I get rid of this condition?
Charles Vostry, Bolingbrook, Illinois, USA, 3 May 2002

• Do any of you do technician deployment of these closure devices? How long have you been doing so? Have your outcomes been as good as or better than physician deployments? Have you found it to be more advantageous from the patient's point of view.
Joanne Zick, Wake Med, Raleigh, North Carolina, USA, 25 Mar 2002

• Our lab is currently trying to implement tech deployment of closure devices. Does anyone have info. reguarding the success or failure rates of docs vs. techs.
Marshall Clark, Wake Med, Raleigh, North Carolina, USA, 24 Mar 2002

• Anecdotally, I have been pulling sheaths and holding pressure for 15+ years, and I can tell you one thing: hemostasis comes a lot quicker and easier with Syvek Patch than stand-alone manual pressure. So, I can't give a more scientific explaination than I already have. I just know it works well, and we ambulate in 2-4 hours (physician preference) without bleeds.I currently have strong beliefs in the Syvek Patch. I have been personally impressed with its performance, and the chance of infections and embolic complications do not exist with this product. I am extremely enthusiastic about the Syvek Patch d/t its possibilities in medical arenas other than the cath lab (ie., surgery, ED, etc.). Give me the Syvek Patch any day. Same ambulation times, no risk of allergic reaction, infection, or retroperitoneal bleeds. For diagnostic cases, it is probably a major waste of money to use Perclose, Angioseal, Vasoseal, or Duet. These devices cost between $175 and $225+, depending on your contract. The Syvek Patch will cost you approximately $50, without the complication risk.
Kenneth A. Gorski, RN, RCIS, Clinical Instructor / Technical Coordinator, Cath Lab, Cleveland Clinic Foundation, Cleveland, Ohio, USA, 20 Mar 2002

• Has anyone developed an opinion yet about the Syvek patch?
Paula Hogsten, KDMC, Ashland, Kentucky, USA, 10 Mar 2002

• Is it possible to have an allergic reaction to the collagen in the Angioseal device?
Giiny Rowland, RN, , Mt. Pleasant, South Carolina, USA, 14 Feb 2002

• I am a CCU RN in Perth Australia. We use the Angioseal with a lot of success however we implemented quite specific nursing practice guidelines, which all but eliminated any problems. The Perclose is still an issue with bleeding and hematoma formation. I am in the process of updating the nursing guidelines for the perclose would be interested in some feedback? Also what is the preferred method for achieving hemostasis mechanical or digital pressure?
V.Jefferson CN Murdoch, STJOGHM, PERTH, AUSTRALIA, 28 Jan 2002

• I had an angiogram done with perclose device closure and my ileohypogastric and ileoinguinal nerve was damaged! It has been almost two years and I am still in severe pain! Neurontin helps but I can only tolerate a small dose. Are there any other neuropathy reports out there?
Donna Hoskin R.N., Sewickley, Pennsylvania, USA, 8 Jan 2002

• Recannulation of the Angioseal after restenosis of the LAD. Use of balloon pump and high doses of blood thinners; Lovenox, plsvixx and aspirin to prevent restenosing
Kathleen Sanacore, 27 Sep 2001

• We have been using the Perclose procedure at our hospital and have had some complications requiring the application of the C-clamp or manual pressure to be held. I am currently collecting data at our hospital on patients that developed hematomas or external bleeding and would like to compare the results with other hospitals . If anyone else has had similar problems and collected similar data please let me know.
Sarah Horner, RN, Jackson-Madison County General Hospital, Jackson,Tennessee, USA, 24 Jul 2001

• For all the cardiologists out there, how have these closure device companies attempted to market their device to you? I am very curious as I feel I have a design that is safer and more reliable than those out on the market today. I am a biomechanical grad student at Stanford and would love the opportunity to speak with any cardiologists that are willing.
Sam Kim, Stanford University, Palo Alto, California, USA, 5 May 2001

• How does the sheath break in the Vasoseal? Is this from technique or product. Is it obvious when the sheath breaks? If so , what are the signs ?
S. Moser, Dayton, Ohio, USA, 24 Dec 2000

• We recently began using the newer generation Perclose device, and I have noticed that patients experience much more pain w/ closure than w/the older Perclose. This is despite infiltrating the area w/ Lidocaine (no epi) prior to closure. Can anyone support my observation and provide recommendations?
Bev Snyder, Wm Beaumont Army Medical Center, El Paso Texas, USA, 2 Jun 2000

• Go to vascularsolutions.com and look at their device. Not approved yet, but should be out soon.
Kevin Skipper, Moore Regional Hospital, Pinehurst, North Carolina, USA, 10 May 2000

• I am not a medical professional, but I am trying to understand what could have gone wrong with my mother's recent angiogram. You sound like you have had some experience with femoral closure devices. If you would be so kind, could you please read the following and let me know what you think. On 12 April, 2000 my 62 year old mother entered a very reputable hospital in good health to have a routine angiogram. She has had one before and she was not too concerned about what was going to happen. Upon completion of the procedure the opening was treated with a femoral closure device. After about an hour in recovery her leg went completely numb. To be brief about it, some of the collagen had gotten into her bloodstream and blocked an artery. A four hour surgery was performed to remove the blockage, during which time she was given 4 units of blood. As a result of the blood transfusions she contracted Adult Respiratory Distress Syndrome (ARDS), she has a significant hematoma in her abdomen, and is currently on a ventilator in addition to suffering from infections, high fever etc. She remained in critical condition for 3 days, and is currently in serious but stable condition (now going on two weeks). My understanding is that her recovery will be long and she will be dependent for quite some time. I don't claim to know anything about medicine, but what I have read about these closure devices would indicate that one would really have to try to screw the procedure up. In your experience have you ever seen this happen? If so, what are the probable causes of ones arteries being blocked by such a device and what questions could I ask the doctors etc. to find out what happened?
Lloyd Swanson, Ridgecrest, California, USA, 26 Apr 2000

• I am 48 year old female who had Vasoseal April 12th. No problems other than the small knot in the groin area.
Patricia C., Daytona Beach, Florida, USA, 26 Apr 2000

• I was needing information on the Angioseal/Vasoseal, one of our physicians has recently started using the Angioseal. I am having trouble finding a CPT code for this & am not sure if we can charge this out as a separate procedure. Please help!
Tabatha Hill, IMA, Inc. (Billing Dept), Bloomington, Indiana, USA, February 9, 2000

• We use Vasoseal on approximately 80%-90% of our patients with wonderful results. I don't have the numbers right in front of me, but we did about 2000 procedures last year and off the top of my head I can only remember very few hematomas, and no other complications. We also do immediate deployment of Vasoseal on a majority of our interventional cases. As long as the ACT is less than 300 we haven't seen any problems. Just be careful when you are pushing the plug through the sheath. Those sheaths are very weak, and they can break and become lodged in the patients groin. Perclose is a devise that we use less frequently, and with less success. We have had no complications that required the patient to go to the OR, however we have had to C-clamp several patients for hours because for one reason or another the Perclose stitches didn't end up in the right place. On two occasions the Perclose needles have ended up becoming separated from the device while still in the body. If anyone has had similar problems with Perclose, I'd like to hear about them.
J. Hanse, Cath Lab Nurse, Columbia Terre Haute Regional Hospital, Terre Haute, Indiana, USA, February 6, 2000

• How do you manage the femoral access site closure? Is PerClose, etc. worth the cost? What is the cost? Are their other options?
Christopher Lawson, vascular product research, Chicago, Illinois, USA, January 31, 2000

• As a patient, I had a Perclose after restenosis, worked great. Recovery was 5 hours faster than a open wound. I did have more pain during the stiching though. The tube was left in place for 4 hours as I remember, and removed without any problems. I hope this helps, as I'm not a medical pro. Dr. Emerson Perin Texas Heart Institute, Houston did the procedure.
Roger Murray, Cleveland, Texas, USA, January 2, 2000

• Yes, I think femoral sealing devices have place in today's interventional field. Such devices must be effective, safety and easy to use.
David Pearce, Vascular Solutions, Inc., GERMANY, November 22, 1999

• What are the pros and cons of today's vascular hole closure devices (perclose, angioseal, vasoseal)??
Aleks Cukic, Racine, Wisconsin, USA, September 2, 1999

• Do femoral access closure devices such as AngioSeal, VasoSeal, etc. have place in today's interventional field considering the cost of these devices, and also absence of need for the continual anticoagulation treatment after PTCA & stenting?
Abhay Pande, MD, Hamad General Hospital, Doha, QATAR, October 17, 1997

• How do you manage the femoral access site post interventional procedure and post diagnostic procedure at your institution?
Dr. Philippe Marco, Perclose Inc., October 10, 1997

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