Holy smokes. . .lots to read here. Thought I'd
give my 2 cents on this topic. From what I have read, some of the pain
that we are subjected to is a result that developes from LIMPING! We
tend to "lean" forward in an attempt to "not" place pressure on the area
that was stented. Believe it or not, no one is really use to walking
that way. This increases pressure on your back and the muscles around
the entry site like you would not believe. Some of us can cause pain
to develope by unintentually disturbing the Sciatic Nerve while placing
that load on you back. . . this can explain the pain in the hip and down
the leg. It is important to develope confidence in the seal as quick
as you can, and walk in a normal fashion. Walk slower, but remain upright
with as normal a stride as possible if you're unsure or feel worried
about the entry site. Having 7 recent angioplasties, my last one (entry
site always in the same spot) I was absolutely pain free simply because
I was confident about it holding just 3.5 hours after the procedure.
It still got Black and Blue, and still swelled to a slight lump, but
the pain never was an issue. I am sure it was all due to not babying
it and not causing the excess load of leaning forward while I walked.
Good luck to all.
RayZ, San Diego CA, December 07, 2005
I had an angio-seal after a heart cath. 11-22-05
and was told to return to normal work duties 11-25-05. On 11-26 pain
in right groin was so bad that I ended up in ER with severe infection
and swelling in the right groin area. I was hospitalized for a week taking
strong antibotics by IV and told that if any symptoms returned after
completing oral medication at home to return and surgery would probably
be needed. I still do not understand everything that is going on with
me! Has anyone had similair problems.
Ronnie , December 05, 2005
Ray, if you stayed in the hospital overnight
with a heavy weight on the groin area, then you did not get one of the
vascular closure devices discussed on this topic. You had your femoral
puncture site sealed via manual compression. Angio-Seal, the most widely
used vascular closure device, was just coming on the market in 1996,
around the same time you had your angioplasties. The question would be
have you had this pain at all during the past eight years or is this
recent? If this is a new development, it is probably not be related to
the femoral punctures at all, but may be signs of something else. We
always recommend that patients consult their doctors, as you are doing.
Please let us know the results.
Angioplasty.Org Staff, Angioplasty.Org, December 03, 2005
Hi: I am a 55 year old male in Ontario Canada.
I had 2 angioplasty procedures done approximately 8 years ago. I have
also had type 1 diabetes for 44 years now. Just recently I have been
experiencing significant pain in my right groin where the incisions were
made about 3 months apart. I am okay as long as I am moving but when
I sit in the car or on a chair for a short period of time the pain is
very sharp when I get up and shoots down my right leg. But as soon as
I get walking the pain is gone. I do not know how the incisions were
closed but on each occasion I had to stay overnight in hospital with
a heavy weight on the groin area. If anyone has experienced this problem
I would be interested in knowing if you have received any answers. I
will be seeing my physician soon on this. Ray, Toronto Canada
Ray Banks, Toronto Ontario Canada, December 03, 2005
I am very relieved to have found this site.
A couple of weeks ago I finally looked up angio-seal online as I realized
that it had been months since the cardiac cath...Feb 2005...and I felt
that I should be feeling better. From the very first I had terrible nerve
pain in my right foot (I did go back to the dr. two days later from this
pain when an ultra-sound was given to make sure there was no blood clot)..especially
the last three toes to the point where I can hardly put any weight on
the right foot making walking very difficult - I am always on the go
so this presents a difficult challenge for me. The original site and
surrounding area throbs non stop - where I can not sit in one spot for
too long..So, now what? Will this go away at some point? What options
are there for relief? Do I return to this doctor or go to the primary
care doctor...Or do I chalk this up to another medical wonder and keep
wondering why I went forward with this test?!
CM Watts, Salt Point NY USA, December 02, 2005
I had the angio seal put in my right leg after
a catherization and after 3 days had a low grade fever for 4 weeks. Leg
ached , swelling in the groin, and after 5 mo. it was better. Still have
pains in vein in leg once in a while. Will this continue? Cant wear anything
tight against leg.
wm judkins, ft myers fl usa, November 22, 2005
Recently been released after angiogram and
stent fitting, this is the second op in two months, in the first one
I had four stents fitted in a row as I had an arterial tear during a
major MI, the first femoral inscision did not have a plug, and healed
up without a problem, the second one which was done about 6 days ago
did have a collagen plug used, at first I had a fairly large swelling
above the cut, about the size of an elongated chickens egg, but not hard.
That has now subsided leaving a hard swelling that is still a little
above the incision and is about an inch long running at right angles
to the artery. it does not hurt a lot but there is some discomfort, I
am hoping that this is perhaps a normal result. For those of you who
have experienced the severe bruising (blue/purple) this is less to do
with the procedure and much more to do with the Heparin injection you
get at the end of it before you leave the cath table, it will dissipate
in about three weeks and is pretty painless. I am a 52 yr Male
Kim, United Kingdom, November 20, 2005
I have previously submitted information about
having a perclose that went wrong on 3-10-2005. Could you please put
my E-mail address on this site. This way I can have people respond to
me that have had similiar experiences with the perclose. Thanks!
Teresa, ktdlmed@frontiernet.net,
Pctn, WV, November 03, 2005
I had an angioplasty 3 weeks ago. I was told
to anticipate a pea size lump in the right groin. The groin had significant
pain, no redness or increased temp, but a lump about the size of an egg.
I saw my Dr. who could not feel a pulse, and sent me for various studies.
Turned out that they were all negative, but revealed a small hematoma
at the site. I had had an angioSeal device and wondered if it is common
for individuals with this device to have hematomas. I also have a latex
allergy and have wondered if the manufacturer does use any products in
the seal device that could be cross reactive? Now after three weeks,
the groin pain has diminished, but I continue to have right leg pain,
behind the knee. I had an angiogram several years ago and they did not
use a closure device and I did not have any of these symptoms.
Marianne, Philadelphia, November 02, 2005
My name is Doug. I had to lay still for 6 hours
after cardiac Cath and had an angioseal device used in my femoral artery.
I had a hemorrhage immediately,which stopped with ice and pressure. Then
the next day 2 more episodes of bleeding. Ultrasound revealed a pseudoaneurysm.The
Docs thought it would be OK but pain and swelling persisted and 6 days
after the cardiac cath another ultrasound revealed the pseudoaneurysm
was larger, and then a vasular surgeon operated to remove the psuedoaneurysm,
and he told me the angioseal was floating inside the psuedoaneurysm.I
reported the details to the FDA, and I hope everybody else does that
had adverse events when an angioseal was used.I don't think Doctors bother
to report.
Doug Huewe, private citizen, Springfield, Missouri USA, October 31,
2005
I had stenting and collagen plug in March 03.
Almost immediately I developed a large lump in right groin. It was very
painful. I went to ER and things got better, however, I was never pain
free. In August 05 the dull nagging pain turned into pain that I am unable
to walk with. I will be seeing my heart doctor in about a month for a
scheduled check-up, I surely hope to get some answers and relief.
Marlene Binns, , Uniontown, Oh USA, October 16, 2005
Just thought I'd post an update on my recovery.
On or about Saturday of last week I has a huge decrease in pain and discomfort
around both entry points. I have continued to progress nicely and would
say that I'm about 90 percent on the right (non-angioseal) and about
80% on the left (angio-seal). Hopefully, there will be no surprises down
the road.
Rex Rohrs, October 13, 2005
Hello: I am a female age 45. I had an angioplasty
done on 9/01/05. I didn't have any blocked arteries. Thank goodness!
I did have alot of the symptoms people discussed on this post with the
Angio-Seal (right leg) for about 2 weeks. After two weeks I started to
feel better but for the past week now I am experiencing a warm sensation
and slight burning sensation off and on all day on the bottom of my right
foot running from the middle of my foot towards the back of my foot and
running a little towards the back of my ankle. Does anyone know if this
could be related to the Angio-Seal? Could it be a sign of a blood clot?
Circulation problem? Something else? I don't see any swelling or anything
abnormal on my right foot. Also the seal feels like a hard pea. Is this
normal? The black n blue finally went away. I sure hope I don't start
getting the pains people are experiencing in the groin, leg etc.. area.
I didn't know about the Angio-Seal til after the surgery. They gave me
a pamphlet/card to keep in my wallet for 6 months that left me scared
to death to do my normal excersing, swimming etc.. fearing I was going
to puncture the area and bleed to death. Appreciate any information you
can provide me. ps: I'm glad I found this site! It is very informative.
Kelly
Kelly, Nixa, Missouri, October 10, 2005
Just to give another viewpoint, I have had six
procedures with the last one about a week ago. The first two were with
manual pressure and the last four with Angioseal (different Dr). I think
they are great. I am up in a few hours. The bruising and lumps disappear
after a few weeks. Obviously I tolerate them well. My second doctor does
an average of six procedures a week and is older. I think that his experience
also counts.
Roy E, Gilroy, CA, October 10, 2005
Rex -- your post gives new meaning to the phrase "side-by-side
comparison" -- sorry, couldn't help it. Seriously, you are certainly
doing all the right things: from having the nurse examine you before
you left to having a physician look at you if this doesn't resolve itself.
It sounds like you are experiencing what is called a hematoma (a
caveat: please do not use this or anything you read on this site or the
internet in general as a substitute for professional medical advice).
A hematoma is a collection of blood under the skin -- a known complication
from femoral punctures, whether vascular closure devices like AngioSeal
are used or not. Sometimes they are minor and resolve themselves. However,
we would recommend that you call the cardiologist who did the procedure
to report this and have someone on his staff talk to or examine you --
they would be more familiar with this complication than a GP, but see
what they recommend. And please, let us know how you fared -- the outcome
would be of help to other readers.
Angioplasty.Org Staff, Angioplasty.Org, October 6, 2005
I just recently had two separate heart
caths done on back to back days. The first was to take care of a 90%
blocked artery and the second to take care of a 65 % blocked artery.
I actually had to different doctors perform the two procedures. The
first Doctor went up through the right hand side femoral artery and
chose to use the pressure technique to close the site. The second went
up the left side and used the Angioseal. It is now 5 and 6 days after
each respective surgery and I have to say that I'm becoming worried
about the Angioseal site. The doctors and nurses assured me that the
pain and discomfort of the Angioseal would subside in a day or two.
This has not happened and is still extremely painful. The bruising
on that side is much worse than it is on the other with severe purple
and black discolorization all the way to the base of my genitals with
my left testicle being completely black and blue. Before leaving the
hospital, I had the nurse examine that area and was told that what
I was experiencing was not uncommon. The pain is basically confined
to the pubic area and my left testicle. It also extends upwards into
my lower abdomen to just below and to the left of my navel. I am scheduled
to be off from work until this next coming Monday and if things don't
improve at least slightly by Saturday I will be going in to talk to
my GP. Ironically, my right side is healing quite nicely.
Rex Rohrs, Whitewater, Wisconsin, October 6, 2005
I had an angiogram fitted with angioseal
nearly three weeks ago and have been in agony ever since. I revisited
my cardiologist who gave me strong antibiotics, visted my doctor twice,
given pain killers which don't work and asked advice on the cardiology
careline. Where to go now? I told myself the results of test were wonderful,
no blockages, but was it worth knowing this for all the pain I have
received? Today is thursday and I will be ringing cardiologist for
another appointment tomorrow, Friday.
anne murray, nyaeg, united kingdom, September 29, 2005
My mother died on June 4, 2005 from complications
of an Angio-Seal device that failed to seal. I would like to provide
everyone that looks at this site information about reporting the failure
of medical devices. These failures can be reported by patients to the
FDA on their "MedWatch" site at: www.fda.gov/medwatch.
Perhaps if enough people report these failures, something can be done
about their misuse.
Debbie Chaussee, Olathe, Kansas, USA, September 29, 2005
I am so glad I found this site!!!! I
had a heart cath done 4 years ago (2001). I have had such pain in my
right groin area. Went to Doctor after Doctor. Found nothing wrong
one Doctor even suggested it was all in my head. When this was done
they put a angioseal in. I ask my heart doctor if this pain could be
from this. I got a fast NO from him. I have heard from other women
that they have the same pain. Could it be the seal is bad or placed
wrong. Help help help!!!! One night after not being able to sleep i
turned the TV on, there was a commercial on from a lawyer saying if
you had a heart cath and an angioseal was placed at groin site call
this number for class action lawsuit. By the time I found a pen number
was gone. Has anyone else seen this. I am 56 years of age and this
is the only problem I have thank the Lord. I cannot use my right name
because I work at the hospital this was done at in Ashland, Ky.
Bridget, Ashland, Kentucky, September 26, 2005
Catherization was recommended by my primary
because he thought my cardiogram was irregular. I had catherization
in August 2004 by an experienced cath team. The angio seal was used
to to close the right groin artery site. Finding was,only 20% blockage
widely scattered. Upon leaving the hospital I was given a folder on
the angio collagen seal. The folder read that I should carry the information
with me for six months, in case of emergency. I had no problems initially,
but, at the end of the sixth month, trouble started with my right leg.
Severe burning pain in the center of my right upper thigh upon exercise,
especially stairs, stepping down, rolling over in bed, sudden movements,
also hip pain,etc. I have seen 3 doctors four times since April. The
first 3 diagnoses were bursitis. Nothing turned up on xrays or sonar
gram. I was given cortizone shots and oral prednisone. Nothing helped.
After an MRI the ortho doctor said I had a herniated disk. Now sending
me to therapy. When I say I have not had one back pain through this
whole episode, they tell me that is not unusual. My whole right half
of my pelvic and hip area are swollen, now that area is painful with
exercise. When I do any of my slow activities, gardening, walking,
standing more than 10 minutes, the burning pain in my upper leg really
kicks up and my leg feels very heavy, sometimes it feels like needles
in my right leg with cramping in my right toes. I relate all of my
pain to the angio seal that was placed in my right groin. Reading some
of the post angio seal usage problems that are posted on this site.
I feel better knowing I am not crazy, because I think all the doctors
so far are wrong. I was a very physically active 69 year old, previously,
very healthy. I am very afraid that to ski, swim, bike, walk, golf,
go to the gym or ride a bike are all now in my past, because of the
collagen angio seal. I am thinking of asking about having an arteriogram
procedure that should show if something is wrong in the artery, but
worried that might make things worse. My next step will probably be
a neurologist, who may understand all the nerves that run through the
area of a catherization. Like all medical procedures and products and
drugs, everthing cannot be the right thing for everyones' bodies. But,
we will probably never hear all the problems that have happened. Thanks
for sharing and listening.
milli becker, retired investor relations, allison park pa, September
20, 2005
I am a 58 yr. old female who 5 days ago underwent
an angiogram. I, too, was not told or given a choice in how the puncture
in my femoral artery was to be closed. While on the table at the end
of the procedure my cardiologist explained that he was going to put in
a collegen plug which will be absorbed by my body and I will be up on
my feet in an hour and a half. I could return to work on Mon. (today)
and he did not need to see me for a couple of months. I should just continue
with the statins ,Plavix and baby aspirin as the blockage in my left
coronary artery was between 40 - 50%. My right femoral artery was the
procedure site. I have been limping due to pain. When attempting to arise
from a seated position I feel like I have a wooden stake in my groin.
My groin and pubic area have turned indigo blue. I have pain when I attempt
to get behind the wheel of my car...so I still am not driving. I have
no signs of infection thank God but do have a lot of discomfort...especially
at night. I usually sleep on my belly or side and cannot do that. I put
a pillow under my knees and lie flat on my back to reduce traction on
my pelvic area. I had an abdominal hysterectomy in '97 and had less discomfort
recuperating from that than this diagnostic procedure. I am definitely
not a happy camper. I don't want to be a whiny complaining patient but
I will call my cardiologist if I don't feel better tomorrow. Enough is
enough.
Phyllis Lazzaro, R.N., , East Rockaway, N.Y., R.N. (Lazz64@aol.com)
on Monday, September 19, 2005
Dear all, If you are having problems
after your heart cath from a closure device find a vascular surgeon
in your local area. They deal with issues like this frequently and
can help you as they fix these types of problems. Make sure that they
report back their findings to your cardiologist and most importantly
the hospital where you had your heart cath so they know what happened
to you and prevent it from happening to someone else.
Dy, Independent, CA, September 10, 2005
Any problems with an angioseal device
should be reported by patients to the FDA Medwatch form 3500 or FDA
form 3500 voluntary reporting. Just get on the FDA website and and
you will be able to find out how to do it. Its just one page to fill
out. Angioseal devices have been found in pseudoaneurysm of the femoral
artery. I don't know if physicians report adverse events so the patient
needs to do it. The FDA cannot recall anything if there are enough
complaints about problems.
D. Huewe, private citizen, Springfiled, Missouri 65804, September
01, 2005
Hi, I'm a 41yr old type 1 diabetic female.
I had a cardiac cath procedure 8/19/05 with the Perclose.No bruising,bleeding
and very little pain. Sorry to hear about everyones problems after
this procedure. Guess I'm the lucky one. Feel great. Maybe it was the
hospital, DR.and staff? Cheers for St. John's Medical Center.
Kathleen Wimberly, Tulsa/Ok., August 30, 2005
MedWatch Form 3500 or called FDA Form
3500 which you can download off the computer and give the details to
the FDA. Everybody that's had a problem with the angioseal should report
it to the FDA. The physician may not have reported it. The angioseal
has been found also floating inside pseudoaneurysm's that develop on
the femoral artery.
D.Huewe, Springfield,Mo. 65804, USA, (dhuewe2@mchsi.com) on Tuesday,
August 30, 2005
I had a angioseal put in after a cardiac
catherization on 12 August 2005. The surgeon said there should be no
pain but I was in pain for a week after and walked with a limp. Since
then a lump has appeared though it's not painful. I really do think
physicians should stop saying there's no pain after one of these devices
is fitted because looking at this site this is obviously not the case
with many patients.
Atanu Roy, London, UK, August 27, 2005
I had a cath done in March 2004. I now
experience pressure pain in my right femoral area. The Dr. used Perclose
on me. Has anyone found any articles on side effects like this so long
after the procedure?
Holly, Accokeek, Maryland, USA, August 15, 2005
My Father-in-law had an angioplasty done
on 23 June. Angioseal closure was attempted but some part slipped into
the femoral artery (don't know the exact details). So a normal proceedure
was used to close the artery. Doctor assured him that there is no problem
that part of angioseal is floating in his artery. A month later he
has major problem in his right leg. Scan showed severe stenosis at
the trifurcation of the right popliteal artery behind the right knee.
Pulse in the right leg was very poor.. So an angiogram of right leg
was done only to find a jelly like substance causing blockage in the
artery behind the right knee which they realized is the part of the
angioseal which was floating around from earlier angioplasty. They
tried to remove the blockage using various methods during this angiogram
but were unsuccessful. Since this proceedure was done in India where
they don't have much experience in treating the complications of angioseal,
we have been given conflicting advise for removing this blockage. We
have been told that a surgery to bypass the blockage should be done.
Other advise is to cut the artey and clear the blockage and put a vein
patch to repair the artey. We were wondering if it would dissolve on
its own since it has been in the artery since 50 days now. We are obviously
confused.
Sudesh, Delhi, India, August 12, 2005
I had a heart cath on July 21, 2005 and
had an Angio-Seal inserted. For the first 48 hours I seemed fine with
little bruising and pain. Then I started to feel pain, as if I had
pulled a muscle above the incision and have been experiencing pain
in my groin area and both hips almost daily, especially towards the
end of the day. I was treated for a bladder infection (blood and bateria)
and took Bactrim, but I don't think the infection is the source of
the pain I am feeling now. I feel that the Angio-Seal has contributed
to pain in my hips and lower back since I suffer from arthritis. Could
I be allergic to the collagen and is that intensifying my arthritis?
I don't see my cardiologist for 3 weeks and am getting sick of taking
OTC pain pills every day.
Rita A. Keiser, Omaha NE , 2005 (rgkeiser@cox.net)
on Saturday, August 06, 2005
This is Jane again. This seemed too simplistic
to mention in my second posting, where I reported that the pain subsided
in a week. However, I did something different on Night 6 after the
AngioSeal was implanted. Normally at night, when I first lay down in
bed, I tense and relax all my muscles and stretch as well as I can,
simply because it aids in my relaxation so I can fall asleep. I hadn't
done my stretch since the AngioSeal was implanted because I was afraid
of opening the wound. On Night 6, I figured it would be safe enough
to stretch, and I'd been hurting so badly I felt I needed it. While
my leg and hip hurt more doing the stretch, I pushed past the pain
and did it, anyway. The next morning all pain was gone. Again, it seems
awfully simplistic, but many of the best things in life are. If it
did help in "fixing" me, I hope it works for others, too.
Jane, Rochester, MI USA, July 26, 2005
I have an angioseal on my right thigh
done 2yrs ago and like most of you I have pain and now I have like
a sore that leaks all day every day for two weeks. I thought that may
be something else but reading from all of you it has to be the angio
seal because since the first day I have cramps in my legs and some
days are better than others
ivelisse gonzalez, springfield,MA, August 05, 2005
Krystal- My 34 year husband had an angio-seal
placed after having a stent placed in his brain August 04 He was in
pain after the 90 days and then he started to get better and he was
in little to no pain. Now a year later and he is in terrible pain in
his right hip, they have done x-rays and found it not to be muscular
or joint pain. Nobody seems to have any answers for his pain, it grows
worse everyday! The doctor has ordered an MRI but no one wants to do
it due to the stent in his brain. Why is his pain so sever a year later?
Krystal Flippo, , Phoenix, Az/USA, July 28, 2005
My name is Janine. My mother had an angiogram
in Feb. 2005 and is still recovering from complications. Shortly after
the procedure she began bleeding internally, the bleeding site could
not be found and consequently she required exploratory vascular surgery.
I was told by the cardiologists that he misplaced the angioseal stating
that fascia can mimic the feel of the artery and that the vascular
surgeon find the seal in the fascia. My mother wound up in the ICU,
experienced life threatening conditions post this procudure, including
almost 2 weeks on a ventilator. After doing some rsearch, including
getting a copy off the OR report, I learned that the angioseal was
found coming out of a muscle in her groin. In addition an artery was
severed with pulsating blood flow. One thing I would like to mention
to the others who are having pain, stiffness and weakness....find a
good physiatrist(rehab doctor), and try some physical therapy. Through
massage, stretching and strengthening exercises you may have some luck
and be able to reduce your symtons.
Janine, Physical Therapist Assistant, Pequannock NJ, July 26, 2005
This is Jane from Rochester, Michigan,
writing back to advise that all the pain I was experiencing in my right
thigh and hip and lower back is gone. Mainly, I wanted to let others
who are logging on to this site for the first time not to get too scared
too quickly. While I was told there would be NO pain, there was plenty,
but it was over in about a week.
Jane, Rochester, MI USA, July 24, 2005
Cilia -- Sorry to hear about your complications.
we would call your attention to an
article published in the Journal of Invasive Cardiology in
June 2004 (J Invasive Cardiol 16(5):247-250, 2004) titled "Impact
of Gender on Femoral Access Complications Secondary to Application
of a Collagen-Based Vascular Closure Device". It does show that
there were significantly more complications with collagen-based closure
devices (in this study, AngioSeal) in women than in men, although the
overall rate was still low for both (1.6% vs. 0.2%). As we've said
before, there have always been a certain number of complications with
femoral closure, whether manual (with sandbags and pressure) or with
the newer collagen devices. The benefit of the latter is to allow the
patient to ambulate within a couple of hours as opposed to lying flat
for 8 or more. But as with any medical procedure there are times when
things don't work right -- and yours seems to be one of those. The
JIC article speculates that smaller arteries in women may account for
the increased complication rate, but we are not aware of any type of "ban" that
has been placed on their use in some states as you have written. Could
you be more specific?
Angioplasty.Org Staff, Angioplasty.Org, July 23, 2005
Hi, I'm Cilla,and I had a heart cath on
10/05/04,the angio seal was used,I was not given the choice of which
device to be used,I was not even aware of which device was used, I
was never told that there were complications with this device,and that
in some states,the usage of this device is banned from being used on
women,because their arteries and veins are smaller than a mans.Right
after my procedure was done,through my right groin,I had severe pain
in that area,I was given a mild pain pill,which did nothing,I was then
given something stronger,and of course I was sent home.To this day,I
have pain almost daily,I have had reactions to pain medications and
to the neurontin,the MRI ruled out blood clots,other tests ruled out
other complications,but there is still pain which is not normal,I'm
also a nurse and followed the post op instrutions to a tee.THERE IS
PROBLEMS WITH THIS DEVICE AND ONE DAY I WILL FIND OUT MORE,I've already
started my own research,and I will continue.Could the fact this device
takes less recovery time,so more are done,per day?Who is really benfiting
from this quicker procedure?????.NOT the patient who has the problems,my
life has been altered,I can only work part time,now.I can't even put
my own socks on or stockings.This is my second heart cath,the first
one done with the sand bag method,no problems at all.I'm only 47,but
have a high risk for heart disease on both sides of my family.Both
parents had quadrupal bypasses at 65,my 32 year old brother had a quadrupal
bypass,he died at age 40 with heart problems,my 35 year old brother
had a heart attack,and had stent placement last year,my sister has
WRP,I will never allow the usage of the angio seal again,I feel in
some people they are very unsafe.......
Cilla Ramia, Concerned patient and nurse, Jacksonville,Florida,
July 21, 2005
AngioSeal was inserted into my femoral
artery 10 days ago after PTCA w/ double stent in my heart's left circumflex
artery. As for the catheter site, I am experiencing bruising that is
triangular in shape, approxiamtely 8" inches on each side. The bruising
ranges from pale yellow/green to patches of red to deep purple. I assume
its normal post surgery injury. The incision site feels like a hard
pea or small marble. As for pain, Its mild to moderate. Some times
it feels like I have been kicked in the groin, sometimes it feels like
a charlie horse in the bruising area. I also have some right thigh
and right lower back pain.I have to walk with a limp and am unable
to sleep well at night. I am unsure how long these post surgery symptoms
will last. I thought after a couple of weeks they would be minimizing
but that isn't happening yet.
B. Viggiano, Syracuse, New York, USA, July 18, 2005
I am a 44-year-old female in good health
who underwent a cardiac catheterization on July 8 (no blockage was
found). The femoral artery was sealed using an Angio-Seal vascular
closure device. The bruising today is about 25-30X the size it was
on the 8th, and the pain I experience varies from high to mid-grade.
Today is July 11 and, even though the discharge instructions I received
from the hospital advised me to notify the doctor of increased bruising
and discomfort at the insertion site, he seemed uninterested during
my visit this morning. I am walking with a limp. The doctor said "you
should be better in 2 days". If I'm not, I will contact the doctor
again. If necessary, I will seek another doctor's assistance. I was
not informed that I had any choice in the type of closure performed
and did not know treatment included an implant device. This is, at
times, extremely painful. Reading the information on this site is scary,
since I don't know how long I will have to endure the pain in my right
thigh and hip. Also, I cannot find any information advising me what
can normally be expected during the healing process. If St. Jude's
can advise, I would really appreciate knowing what is normal.
Jane, Rochester, Michigan, July 11, 2005
Ronnie -- the term is "adipose tissue" and
a definition can be found here.
And it is, in fact, just like you say -- a "chunk of fat bulged
out". I don't see any references to this problem being a result
of Angioseal, but the substance in Angioseal and most other vascular
closure devices that promotes closure is collagen. Collagen is a protein,
the most common protein found in the body. Collagen, like adipose tissue,
is part of the general heading "connective tissue". There
might be a connection, but it might be due to something else as well.
Angioplasty.Org Staff, Angioplasty.Org, July 09, 2005
This is from Ronnie in Flatwoods,Ky this
is a followup of the heart cath i had on may 12-05.I have swelling
of the right upper leg just on the outer side of the groan, the swelling
is about the size of my hand and looks like a chunk of fat bulged out
on the side of my leg not sore,hot,red or throbing, cardio said he
had never seen this happen before, had a ultrasound done was ok, then
had ct scan the findings is atapost tissue with slight enlargement
of lymph gland. what is atapost tissue and what could cause this.Could
this be from the angio seal or something else. has this been reported
before. if any info of this please e-mail ronnie_blackburn44@yahoo.com
thanks
ronnie, Flatwoods, ky, July 09, 2005
Like everyone else, I had a cardiac cath
procedure (performed in December 2004 - my third - and the only one
to have used this type of closure). I was told that the "plug" would
dissolve in about 90 days. Here it is, July 2005 and I still have a
painful lump at the site, that seems to only become more aggravated
every day. Only 15 to 20 minutes of sitting in the driver's seat has
me in pain. The manufacturers of these devices need to go back to the
drawing board for more research, I'm afraid. - they are miserable.
Amy Kolka, Bay City, MI, USA, July 06, 2005
Nicolina -- we're starting to get some
postings in this topic from patients who have had manual compression,
not one of the newer vascular closure devices -- if we get more perhaps
we'll start a separate topic -- but as you can see, there are complications
and problems with the older methods as well. In any case (and remember,
we do not and cannot give medical advice -- nothing stated here sould
be considered a substitute for advice from your doctor) you've a clearly
documented bleeding complication and you are now feeling discomfort
again. We would urge you to "push through" the healthcare
bureaucracy if you are not feeling right. You were correct the first
time about the bleeding. At the least, the medical professionals should
provide you with a clear explanation of what you're feeling and why
-- if for nothing else than peace of mind, which is very important
in recovery from any procedure. But pain, distended abdomen, headache,
etc. seem to us like reason enough to seek attention. Good luck and
let us know the outcome.
Angioplasty.Org Staff, Angioplasty.Org, July 5, 2005
Hi, I am a 36 year old female that just
recently had a cardiac cath on July 1-2005. Immediately following the
procedure during manual pressure I began complaining of pain in my
lower right abdomen. The nurse called the doc and he said everything
was fine so I was transferred to recovery. In recovery I continued
to tell the nurse that my abdomen was in a great deal of pain. Irregardless
of my complaints and low blood pressures, I was discharged on schedule.
That night I tossed and turned for most of it and didn't get much sleep
if any. I returned to the hospital the following morning and a ct-scan
reveiled that I had been bleeding into my parateneal cavity. Over Friday
and Saturday I had Hematocrit and Hemoglobin drawn and they saw no
dip in these bloods so they released me to home on Monday morning.
The problem is that Tuesday July 5 I sit here with a distended abdomen
in quite a bit of pain again. Is it possible for me to start bleeding
again and when should I be worried enough to return to the hospital.
If my H and H were good is it possible that I have a slow bleed and
my body is compensating by producing more RBC's and lowering my blood
pressure. The other thing I am concerned with is that I have had a
head ache since this procedure that won't stop is this related as well?
Nicolina Hedrick-Nelson, Hyde Park, NY, July 05, 2005
I've had 3 cardiac caths, each 6 months
apart. A different vascular closure device was used each time; angioseal,
perclose and a collagen plug they didn't identify (I only had to remain
flat about an hour afterwards). I experienced many lumps and knots
post-procedure - especially with the first cath - and a few of them
remain even 1.5 years later (you can feel a pulse in these knots).
The lumps are obvious and due to their size, the last cath had to be
done higher up the femoral artery. My cardiologist never investigated
the problem. In fact, when I continued to demonstrate heart problems
after a stent was put in my LAD, he said infection was probably the
source of ALL my symptoms - with the blockage being a "chance find".
He terminated me as a patient and to date, no other cardiologists will
accept me - each telling me to return to my original doctor. Does anyone
know what these knots and lumps are around the closure site? I'd feared
that perhaps a small aneurysm or two had formed - but I have nowhere
to go for help in finding out.
Pam, Sierra Vista, AZ 85635, July 03, 2005
M. Collins -- Allergic reactions to vascular
closure devices are not unknown. The device uses collagen to "seal" the
artery, and the collagen comes from cows (bovine collagen) and a very
small percentage of people may be allergic to bovine collagen or may
experience some of the other possible adverse reactions listed on on
the Precautions section
of the AngioSeal website. You might also have your cardiologist call
St. Jude for information on this. They publish contact information here.
You may try calling yourself. Perhaps they have a clinician on staff
to help patients deal with adverse reactions. We'll try as well. Allergic
reactions can also occur from a variety of other sources, the contrast
dye used in the procedure, certain medications, etc. You did the right
thing to consult your cardiologist. Hopefully you can get to the bottom
of the problem. Please let us all know.
Angioplasty.Org Staff, Angioplasty.Org, June 26, 2005
I had a cardiac cath at the end of April
and an angioseal was used. The following day I had approx 5 minutes
of intense, crampy pain. There was no noticeable swelling, however
the crampiness persisted. I was unable to walk normally and sitting
was uncomfortable. After 2 weeks, my leg started swelling. I returned
to the cardiologist for an ultrasound and a groin dvt was discovered.
At the time, I was told this was highly unusual and not a known complication
directly related to the cath procedure. I returned to the cardiologist
recently and learned that a second patient had the same unusual complication
a week later. In retrospect, they are wondering if the other patient
and myself had an allergic reaction to the angioseal devise since we
both showed lymph node enlargement on ultrasound. The swollen lymph
node probably compressed the iliac vein and caused dvt. I have not
been able to find clinical trial information to see the incident rates
of allergic reaction to the angioseal device. I am wondering if there
may be a problem with a specific lot number of the device since the
cardiologist office has a high volume of patients and has only seen
this occur twice over many years (and both times were within a week
of each other approx 6 weeks ago).
M. Collins, Columbus, Ohio, June 25, 2005
Mrs. White -- this topic is about vascular
closure devices, like AngioSeal, etc. You didn't note whether this
type of device was used (if your husband had to lay flat for many hours,
then it wasn't). Is this still going on? The femoral nerve runs alongside
the femoral artery which is the "groin" artery used in catheter-based
procedures. It's possible for that nerve to be traumatized and in rarer
cases damaged during a procedure. Sometimes these effects are transitory
and resolve after a few days. In any case, we definitely recommend
discussing ANY unusual after effects with the cardiologist.who did
the procedure.
Angioplasty.Org Staff, Angioplasty.Org, June 25, 2005
My husband had two stents inserted after
an angiogram Friday, 17 Jun. He is experiencing numbness and tingling
in his right leg on the side angiogram was performed. No pain at the
present and no bleeding in the area of groin. Could this be a serious
affect and need immediate attention? Thanks for your response. Need
soon if possible
Robert E. White, Retired, Carriere, Missouri 39426, June 22, 2005
I am updating my previous responses of June
6, 2005 when I had a angiogram with an angioseal on June 1, 2005 at Medical
City Hosp. in Dallas TX. I went back to the ER a couple of days after
the angiogram, they said it was nothing, all the pain and shocking feeling
I had in my leg/groin area (I could hardly stand up) so they sent me
home; two days later I am back in ER, cannot stand up at all, feeling
numb in foot/toes, extreme pain still in my whole leg, shocking feeling
when standing thru my whole leg.., admitted for 4 days, they said no
blood clots in leg, so they said "all this problems MUST be coming from
all your back problems "(previous back surgeries years before this angiogram), "NO
way this is from the angiogram or angioseal, go see a neurologist or
neurosurgeon to treat my low back area"...I did not have this problem
in the right leg/groin/foot area BEFORE the angiogram/angioseal...they
just passed me on to someone else..the cardiologist did not even come
see me in the hospital, just an internal medicine doctor. They acted
like it was just all in my head or my "back" , I still hurt like hell,
I could not even walk out of the hospital, but they sent me home and
said to rest and get back to normal.. no compassion at all, I still have
numbness and cannot sleep and hurt like HELL.. they just acted like I
WAS nobody after THEY put this thing in my leg and refuse to take responsibility
for all these complications I still have... I cannot work and can hardly
stand up I faxed the info on this website/forum and asked my cardiologist
to read this site info so he could see it was not just in MY Imagination
all these problems I am having, others are having similar symptoms and
even worse problems. He was not interested obviously. I am so very disappointed
in the way I was and am still being treated after this angiogram and
angioseal..They just DO NOT CARE what happens to me NOW. Has anyone in
the Dallas area had similar problems with this procedure/device? I had
to go online to even find info on the angioseal at all, I was only given
a "card" to carry in my wallet stating I had an angioseal in my artery
in case of emergency; hell the people in the ER, the ER doctors did not
even know what it was and they did not care...
M. Spears ladyredjax4453@aol.com, Dallas, TX, June 20, 2005
I'm a 48 year old female,I just had a heart
catherterization on 6/15/2005 they used a Angio Seal. I have been in
pain since, on the same day of release had to return back to the hospital,
because of severe pain and could not move my leg, there is bruising in
the area and still have pain, also have severe pain in lower hips or
should i say buttocks that was not there before, after this ordeal i
feel like an 80 year old women, im just so upset about all of this, i
also read where after 20 mins some could get up i was told not to move
for 5 hours i dont understand that,also have had alot of coughing so
can anyone tell me what is going on please,
Lisa Powell, Cottondale, Alabama, June 19, 2005
James -- if a sandbag was used and your
husband was immobilized for 8 hours, then no vascular closure device
was used. It was done "old school" using what's known as
manual compression -- which is the way all femoral
punctures were closed before the advent of vascular closure devices
over the past decade. These devices use collagen plugs, and other methods,
for sealing the femoral puncture site in a relatively short time. Your
story points up the fact that, while we are reading in this Forum Topic
about all the complications with these newer devices, there are also
a not insignificant number of complications with the "standard" manual
compression methods. Whether the complication rate is higher or lower
will be the topic of an upcoming article on our site. We don't give
legal advice -- not even medical advice really, just places to find
information. I would thoroughly discuss your husband's situation with
the vascular surgeon and/or a neurologist. Please let us know what
happens and if you get any useful information. Good luck.
Angioplasty.Org Staff, Angioplasty.Org,
June 16, 2005
My husband had a heart cath with stent
placement on 4/21/05 (Thursday). Records do not indicate type of closure.
They had a sandbag on his right groin for 8 hours then removed the
sheath and placed sandbag for another 4 hours. The sandbag was removed
and he was told he could turn side to side in the bed and get up and
walk in 6 hours. The sandbag was off for maybe one hour and he started
having burning at the cath site which was the femoral artery bleeding
into the thigh. The sandbag was replaced and was not taken off until
about 8:30 a.m. on 4/22/05 (Friday) at which time we were told by cardiologist
he could go home and return to work on Monday; he did not detect the
small hematoma when he discharged him. I first attempted to take him
home and got about 15 miles from hospital and my husband started burning
at cath site and upper thigh was swelling. I took him back to the cardiologist
who sent us to Radiology for ultrasound and injection of thrombin to
clot artery; this was done 3 times before artery was clotted off. The
Radiologist had us wait to hear from the Cardiologist; about 1 and
1/2 hours passed we were still sitting in hallway and Radiologist said
he had not heard back from Cardiologist "Go on home you will be fine." I
attempted the second time on Friday 4/22/05 to take my husband home.
I got about 1 mile from home (about 35 miles from hospital) and my
husband began having severe pain at cath site and upper thigh; upper
thigh was swelling again. Luckily the bleeding stopped and I had to
take him back to the hospital where he was readmitted. About 3 a.m.
on Saturday 4/23/05 the artery started bleeding again at which time
the Cardiologist was called in and he called in a Surgeon who performed
emergency surgery to close the femoral artery with 2 stitches and 19
staples to close incision. He had to be given 2 units of blood because
of amount of blood he lost. The incision is healed but the hematoma
has not gone down at all. It is now 6/13/05 and we are going to another
surgeon to have this hematoma drained and we pray there will be no
infection because of all the old blood in the thigh. We were told there
were 2 units of blood there but it would be dissolved into the body.
For some reason this did not happen. On top of all this my husband
has developed symetrical neuropathy - both hands thumbs, forefingers
and middle fingers no feeling and both outter thighs burn and hurt
so bad he cannot sleep, he has to have pain medication and is on Neurontin
which is not helping him. Any one dealt with or heard of any of this?
Do we have a law suit regarding this situation?
James, June 13, 2005
my mother bled to death after a perclose
angiogram. lawsuit pending. this was in feb of 2001.
gerri nizza, ridgewood, nj, June 12, 2005
As a possible help to the many complaints
and questions we get in this topic, here is information
on possible complications of AngioSeal from the St. Jude Medical
company web site. I would also call your attention to a press
release from St. Jude Medical from January that announced their
5 millionth AngioSeal implant. So does that negate the concerns and
problems reported in this Forum Topic? It's true that the complication
rate is low, but it's not zero! In the words of Andreas Gruentzig,
the inventor of coronary angioplasty, from back in 1985, "I
am speaking all the time about complications...Well fortunately those
complications are rather minor, in percentage....the reason I speak
up about complications. It is not because it is such a major problem.
But it is always my major concern in selecting patients or treating
patients." (See
the RealVideo clip.) He was speaking about complications of angioplasty
in general. Today complications from vascular closure devices are relatively
low statistically. Yet if you happen to be one of the unfortunate patients
who suffers a complication, the effect can be devasting, as noted in
this topic. We can only state that patients should be as well-informed
as possible and that, should a complication occur or be suspected,
do not hesitate to contact your cardiologist. Don't worry about bothering
him/her. Early recognition of a problem may make all the difference.
Angioplasty.Org Staff, Angioplasty.Org, June 10, 2005
I am 44 yr old female. I had an angiogram
5wks ago w/the angioseal. While in recovery had cramping in right leg,
barely a pulse in right foot. Vascular Surgeon emergently took me to
OR to find a critical blockage in femoral artery caused by angioseal
which had traveled also piece of plastic. Been out of work ever since & am
in chronic pain 24/7 in groin & right leg. Also numbness. My surgeon
says I may need more surgery in the very near future! I wish the cardiologist
had informed & discussed w/me the potential risk of the angiogram.
I was told I was extremely lucky to have kept my legs also to be alive!
Anyone have any suggestions on how to function w/this condition or
would like to share w/me their experience, would love to hear from
you. email: kellyty43@aol.com
Kelly, North Arlington, NJ, June 07 & 09, 2005
I had an angiogram (right leg) on June
1, 2005 at Med. City of Dallas, TX, an angioseal was used..I have had
pain not only in the groin area (where I have alot of "knots-lumps" in
the groin area) and have had alot of pain and numbness in the right
leg, especially have pain/numbness/throbbing in right foot/big toe..
pain in constant, have had slight fever since angiogram last week,
top of my foot is getting numb and ankle/calf/thigh feel "weird--tingling/trobbing
at times, and hard to walk on; cannot sleep hardly at all, maybe a
2-3 hours in a 24 hour period.. was not told of the problems I would
have after this procedure..I feel worse every day...when should I call
the doctor ? what is the normal pain/symptoms after this procedure
with the angioseal? I was only given a little brochure about the angioseal,
it does NOT state what is normal after it is put in my femoral artery
and what is not normal and what symptoms to look for and WHEN to call
my doctor to find out if something serious is going WRONG with this
device? I have had two bad staph MRSA infections in the past 1 1/2
years with bad back surgeries, so I am a carrier of staph in the low
back area,and I am worried about any infection anywhere in my body,
especially in my femoral artery/leg, etc. when should I be worried?
and when should I call the doctor? can anyone answer these questions
for me? I do not want to spend my time or the doctors , if what I am
feeling is normal and will go away in a week or two.. but from reading
these letters on this site, I am really worried now.. mary S., Dallas,
TX Ladyredjax4453@aol.com
Mary Spears, Dallas, TX USA, June 06, 2005
Ronnie -- as you've described your situation
since your visit, you're right -- it doesn't sound at all like a hematoma
which would in fact be a significant discoloration. Not sure what the
swelling could be, possibly a sensitivity to the collagen in the AngioSeal
which should resolve itself. The electric shock you felt is most likely
a nerve. Do you have numbness? That might indicate possible nerve damage;
otherwise it was nerve trauma which does get better. Also pain and
redness might signify an infection, so it's good you don't have those
symptoms.
Angioplasty.Org Staff, Angioplasty.Org, June 3, 2005
This is Ronnie again. When the DR was
putting in the seal I had the feeling that I was being shocked with
electric down the inside of leg to knee. Could this swelling be from
nerve damage or leaking of fatty tissue. thanks
Ronnie, Flatwoods, ky, June 03, 2005
This is from Ronnie with the swelling
of right leg from heart cath thanks for the info. Saw family Dr 6/2/05
-- he said that the swelling was rare. I saw cardiologist P.A. -- she
said to use heating pad, if it gets worse call. I am getting more concerned
about this i had the angio-seal once before with no problems, I still
do not have any bruising, redness or pain just swelling on the part
of leg below the crease; the swelling is not hard just like fatty tissue.
If this was bleeding under the skin should it be bruised or some form
of discoloration by now. Need more input thanks
Ronnie, Flatwoods KY, June 03, 2005
Ronnie -- sounds like a hematoma, which
is what your doctor said -- blood that has leaked under the skin (a "black-eye" is
a form of hematoma). This is something that might go away in time,
if minor, but treatment of hematomas is very dependent on size, etc.
and determination should be made by a doctor. Your doctor seems to
indicate that this is not a problem, yet there may be things you could
do. Ask your doctor (and let us know what he says). By the way, you
posted to the vascular closure device topic. Did you have one (AngioSeal,
Perclose or similar?).
Angioplasty.Org Staff, Angioplasty.Org, June 1, 2005
I had heart cath on May 12, 2005; went
to see doctor on May 22. I have no soreness, redness or tenderness
in the puncture site. I do have swelling in the top of the leg like
a fatty soft spot. Doctor said could be blood that has leaked under
the tissue. Does not seem concerned, but I am. It is now May 31 and
the swelling is still there, what do you think i should do?
Ronnie, Flatwoods, KY, May 31, 2005
Add my complaint to the long list of problems
with the collagen plug. My right femoral artery is 90% blocked now,
and cannot walk over 100 yards without severe pain in my right leg.
Too bad we were not advised of the many problems using this type of
a closure device.
David Clark, Enid, OK USA, May 26, 2005
Dear SDevault --
thanks for your posting. We are quite amazed at the number of complications
we are seeing posted in this topic. And your comments add a much-needed
balance. There are two million angiographic procedures performed
each year in the U.S., and there is a known complication rate for
any medical procedure. Moreover, a Discussion Forum like this one
becomes a "magnet" for patients reporting their complications.
The vast majority of patients are, as you note, being helped and
made more comfortable after these procedures by use of the various
vascular closure devices. That being said, the extent and effect
on the patients' lives of the various complication being reported
here is extreme and needs to be publicized and addressed. Perhaps
a greater awareness of possible complications is needed -- perhaps
if a patient complains of any of the problems listed below, they
can be dealt with earlier and more successfully. In any case, I believe
that patients should be informed of their choices and be allowed
to make them, in this case, for themselves. We're working on a comprehensive
article about vascular closure devices and will post the link in
this Forum when it's online. If you want to be informed when this
happens, I suggest registering with
us for our newsletter.
Angioplasty.Org Staff, Angioplasty.Org, May 25, 2005
I had a Heart Cath on 3-10-05 after having an
abnormal ekg. I am 39 yoa and a RN. When I got up to walk i could not
walk. They kept me over night stating I had a fistula that would resolve
in a couple of days. After returning home for two days, I barely could
walk. I had an arteriorgram that reflected a femoral artery occlusion
from the perclose. After five hours of surgery a five inch blood clot
was removed. Also my saphenous vein was removed to patch my femoral artery.
Eleven days later I had a massive hematoma about 12 inches long and eight
inches wide and had to have surgery again and a JP drain put in. I was
fortunate I did not have to have my leg amputated. I had no pulse in
my leg when I went into surgery and it was cool. At the present time
almost three months post-op I am still having problems with numbness
and pain. I still have some of the hematoma left and my skin is discolored.
I am very upset I was never told about the perclose until after the heart
cath I know I would have chose the sand bags if given a choice. By the
way I had no blockages. I still had sever chest pain up to two weeks
post-op. I am now on cardizem and I am very mad. I could develop scar
tissue in the future which will again decrease blood flow to my leg!
Good Luck Teresa
Teresa, USA, May 24, 2005
I work in a cardiac catheterization lab
where we use the devices to close femoral arteries. We use the device
on well over 90% of our patients. Patients for the most part love the
device, especially those who had procedures in the days before the
use of angioseal and perclose. The old way, someone had to hold pressure
for at least 20 minutes to stop the bleeding and then you were on bedrest
for at least 6-8 hours following the procedure. Bedrest, I mean totally
flat on your back the whole time. For many people that is horrible
torture. These devices, like anything, come with minor risks. I have
read the package insert and I do insert them. I explain to patients
about the use of these devices. For those who think they need to contact
a lawyer, for what? No one did anything wrong nor is there a problem
with the device. I have seen 2 patients in 2 years need to go to the
OR to have a femoral artery opened because of a complete blockage.
In our case it was discovered within hours of the cath while the patient
was still here. For the comfort and timely manner patients can get
in and out of here, I think it is worth the risk. I would let someone
use a closure device if I had a procedure. Sorry to those who have
had such a difficult time. On the other hand, did you resume normal
activity as soon as you got home. One man was driving the next day!
How about lifting and using stairs? People take a bad experience and
everyone is fueling the fire for each other making it much worse than
it really is.
SDevault, Cardiac Catheterization Lab, Massillon, OH United States,
May 24, 2005
I am a 39 year old female, and I had
a Cath. procedure in August, 2004 due to supposed massive blockage
in the anterior wall of my heart (results from stress test). The cath
showed no blockage. Without my knowledge of this devise being used,
an Angio-Seal was used to close my artery. I was sent, and returned
to work 2 days later. I began having extreme pain in my right leg.
I was unable to walk more than 5 feet without having to sit and cry
from the burning and numbness. I went to the doctor a week later, and
he said it was typical. One week after that I was back at the doctors
office with same complaints. He sent me to have an ultrasound for an
pseudoanyserism. The ultrasound showed that there was complete blockage
to my right artery. No pluse in my right foot. I was immediately scheduled
for a prosedure the next morning (to be done by a different doctor).
This procedure was to blow out the clot that had formed around the
Angio-Seal. Well to say the least, this procedure didn't work. I was
admitted to the hospital upon finding a surgeon that could remove the
Angio-Seal. Mind you this was Labor day weekend too. In the mean time,
I was BLACK from the bottom of my breasts to the top of my knees from
the pressure that was applied to my left artery after the procedure.
It took four people taking turns ro stop the bleeding. My bladder was
severly bruised. I passed nothing but pure blood for 2 days afterward.
and, I had an allergic reation to the blood thinner they gave me. I
was told not to get out of bed that the clot could break loose. So,
I laid there from Friday until Tuesday until they could get a surgeon
scheduled. (He was on vacation for the Labor Day weekend). The Angio-Seal
was removed and I was sent home the next day with no restrictions.
I returned to the doctor and surgeon for follow ups ant told them of
my complications. I was told this was normal and it would go away with
time. Well, to tell you the least, it has been 8 1/2 months since the
Angio-Seal was removed and my life is hell. My right thigh is completely
numb from the grion to the knee. My right leg goes numb after just
walking to the mail box. I can't sit still for more than 10 - 15 minutes
without my legs going completely numb. Walking up stairs or a slight
incline is impossible. The burning is too horrific. It has taken me
almost 45 minutes to write this entry because of not being able to
sit at the computer for long. My advise to anyone getting any heart
related porcedures or surgeries, DO NOT allow the Angio-Seal to be
used.
Sharon, Shreveport, LA, May 23, 2005
I had a cardiac catheterization with
Perclose closure on March 24, 2005. Immediately following he procedure
I was unable to walk because of excrutiating pain in my leg. I was
sent home and after 5 days with a cold leg and pain underwent surgery
to remove a five inch blood clot which had occluded my iliac and femoral
arteries. My surgeon says the occlusion was a direct result of the
closure device. I have seen a lawyer who told me that my best course
would be to join a class action lawsuit to have the device removed
from use.
Carol Linn, Sun City, AZ. USA, May 18, 2005
Update from Dee, Columbus, OH. My last
posting was on March 21, 2005. I would like to update you on the latest.
My severe pain turned out to be something after all. It was a totally
occluded (blocked) femoral artery after a cardiac catherization two
weeks earlier. (I had been in severe pain for two weeks and the doctor's
office pretty much blew me off. The only way I found out was my insisting
with my cardiologists office that I couldn't be in so much pain without
something being wrong). After the femoral artery was unblocked by a
vascular surgeon, two weeks later the site became infected. I was put
in the hospital for IV antibiotics. On the day I was to be discharged
I had a short incident of bleeding from the site. The physicians didn't
seem concerned and sent me home. The next morning I woke up covered
in blood. Spent several hours in the emergency room before they decided
to go in and explore to find out the problem. I was told of the possibilities.
Right as they were coming to take me to surgery, my femoral artery
blew and disintegrated when the surgeon went in to see what was going
on. I had to have a femoral artery bypass. (The doctor told my husband
I was lucky I had not bled to death at home). I am fairly young and
even though stress tests and EKGs indicated I possibly had heart blockages,
I didn't have any. That makes this entire thing even worse. I am still
very ill but at least I am home. I have no idea what the future holds
because it appears I have nerve damage to this leg as well. All as
a result of a "simple" "routine" heart catherization. My advice - ask
lots of questions and insist on answers.
Dee, Columbus, OH, May 05, 2005
I had a angio and one stent placed on
April 22 with Angio Seal. I had the procedure on Friday - and drove
home Saturday morning. Worked around my shop Sat/Sun - went to work
Monday and each day since. I have no real brusing (one about the size
of a dime), no pain unless I push on it and am feeling great. Am I
about to experience all this stuff you all are talking about??!!
Bud Bulmer, Lakewood, CA USA, April 27, 2005
My 84 year old mother had an AngioSeal
placed in her femoral artery after an angiogram - four days later she
was to have a femoral artery bypass - from all indications the groin
incision was made in the same place - since the surgery she has experienced
severe pain in the knee and front of her leg - does this have anything
to do with the angioseal?
Sheena Asconi, Christiansburg, Virginia, April 26, 2005
I am a very healthy, 56 year old woman
who had an angio seal in my femoral artery in November 2002 when a
cardiac catheterization was done in the Reading PA hospital and no
problems were found as to why I had chest pain. After the angio seal
was placed, I had numbness and soreness which I was also told would
clear up in 2 weeks and given Tylenol. After 90 days I still felt it
was sensitive so the cardiologist checked it and found "no problems".
Now, it has been over 2 1/2 years and occassionally I have pressure
at the angio seal location and still feel uncomfortable, also I feel
gas gets trapped in the area and sometimes it swells slightly. I would
never have allowed this procedure had I known. I eat garlic and use
herbals and keep exercising and overall I'm very healthy but it does
concern me. I am wondering if there are going to be further complications
in the future from it?
Suzy Randyl Fry, Grand Junction, CO, U.S.A., April 24, 2005
[to P. Antrim] Your message on board is
old [September 24, 2002] I think but angiogram seals are proven now
to be very dangerous causing problems in many people including my mother
who is having surgery tomorrow to fix this problem which they say is
fixable thank god. Her doctors didn't even conceive this could be the
problem until she went to another hospital heart instiutute who found
it right away and also told her they don't use these devices anymore
because of the problems they have created...her's didn't dissolve and
cut off all blood supply to her leg. So, glad you had a great experience
but many didn't.
WB, April 18, 2005
I had a cath last week. It was closed
with the Angio-Seal. (I was never asked or told of this device). My
concern is I have had 3 stents and balloons put in my left leg over
5 years. Severe peripheral artery disease. The card I was given states
plainly that I should not have gotten this. We called the dr. today.
He says we are trying to act as drs. He also says that it will all
be dissolved in 2 (TWO Weeks!) I replied that this is not what flyer
states. He remarked that he had never read it! I am living in fear
of an occlusion.
Jane Howard, Bessemer, Alabama, April 18, 2005
I had a cardiac cath done Jan 2004 and
sealed with an Angio-Seal. On arrival home I experienced extreme pain
in the right groin area where the procedure was done. Bruising followed
and within a couple weeks I was back in the hospital with a deep vein
blood clot. To this day I have pain in my right groin area, feels like
a big knot when sitting and burning sensation in upper thigh and lesser
pain in lower right leg. Right leg has never felt the same after the
procedure.
Ken, Perkasie, PA, April 15, 2005
I had carciac cath 4/11/05 which was
closed by Angio seal, without my consent mind you. I was not given
a choice but I am all for new advances in medicine. I am 33 yr old
female with preliminary diagnosis of Arrythmogenic Right Ventricular
Dysplasia. The cath was done only to rule out CAD. I am wondering if
it is normal to have pain radiating doen the right thigh to the knee
after walking just to the bathroom. Much more pain is noted when ihave
to go upstairs to go to bed at night. I work as a CNA, lots of walking,
running and heavy lifting. I am scared to go back to work and have
this thing fail not to mention the pain is already intense with minimal
movement. Anyone have any suggestions or thoughts about what I am feeling?
Please tell me this is going to just go away in time. After all it
is only 48 hours post cath. Thank you
Laura, Wisconsin, USA, April 13, 2005
I had a cardiac cath done a year ago this
past March. They closed off the site using a collagen plug which I
believe they refered to at the time as an angioseal. A week ago I returned
to the work force and spend 6+ hours on my feet. Suddenly I am getting
an intense burning pain at the site where the catheter was inserted.
The pain radiates down into my thigh and also up and around into my
hip. The severe burning lasts for about 1-3 minutes and then dispates
to just a numbness in the area. I also have a sensation as if my leg
were being twisted..and the limb feels very heavy. Has anyone else
experienced any of these symptoms so long after what was basically
an uncomplicated cath? Incidentally I had no real significant pain
at the time the procedure was performed. If anyone has any info.. I
would greatly appreciate hearing from you. Thanks a bunch..
Deb, Trenton, New Jersey, USA, April 11, 2005
I had a cardiac cath closed with closed
with angio seal. two weeks later, much pain in groin, legs hurts and
feels numb, also developed a painful nodule on side of my leg. has
anyone had this happen. i've been told maybe some nerve damage and
may need therapy. what recourse do we have?
linda, April 09, 2005
I am 67 female, 2 months post 2 stents
on 2 days, with Angio Seals in both groins. I Have no pain in one groin
but the right groin gets dull constant pain for 24 hours after stationay
bicyle exercises of only 18 minutes and also hurts if I flex that hip
hard eg sitting up from lying. Has anyone had this typ of pain ? Do
you think it will go away - at least I can walk OK. April 2005
Liz Richards, Melbourne, Australia, April 07, 2005
My husband had an angiogram on April
5, 2005 and an angioseal in his right femoral artery. Everything seemed
fine until the next morning when he sat in his office chair and instantly
felt severe pain in his right groin. We checked the area and found
instant bruising and swelling. He applied an ice pack and took tylenol
to get through the day but he's still very uncomfortable 12 hours later.
After reading all the horror stories, I'm not sure what to expect except
that neither one of us will be sleeping well tonight worrying about
it. We'll contact his physician in the morning, but any advice would
be helpful to avoid what others ahve gone through. The instant, severe
bruising and swelling is our concern.
Melody De Leon, , Lakeport CA, April 06, 2005
I had an ablation done and they used both
femoral arteries. i don't know what they used to seal it, but after
reading these posts, I'm gonna ask! It's been 1 1/2 yrs and I'm finding
that losing weight and walking more, is causing both areas to be more
tender as time goes on. I had a massive bleed in the left artery area
and was out for 5 weeks and it took 8 months for the bruising to go
away. My hemocrit went to 8.2 during the bleed. It was the worst experience
of my life and I had mine done at UCLA! I'm thinking of getting an
attorney after reading all of your complaints. This is absurd, and
seems like too many people from varying backgrounds and ages to all
have such major problems. I had no idea it could be so bad. I had numbness
in the other leg for nearly 6 mos as well. Thanks for your responses,
it answers a lot of questions for me.
CMcGraw, Bakersfield, California, USA, March 29, 2005
I had an heart cath done 1 week ago. As
the Doctor was placing the Angio-Seal I had the most awful pain down
my leg and up into my hip. It was the worst pain I have ever felt.
Now I have pain in my hip all the time, and some down my leg. I am
having a hard time getting around and trying to work. I called the
Doctor and was told "It's nothing" well the "nothing" is killing me
OTC meds only give slight relief. My pain is mainly in my hip can anyone
relate or have any suggestions?
Shannon, Hutchinson, Kansas, USA, March 29, 2005
Can someone advise me of the success and
failure ratio of using the perclose technique to close the femoral
artery after a catheter has been inserted in the groin area vs. success
and failure of closing the artery using compression technique.
Jim Barlow, Hot Springs, Arkansas, USA, March 28, 2005
I had a cardiac catherization 10 days
ago. I had no pain until I got up after two hours of no movement. The
angio-seal was used as the closure device. The very first time I stood
up I had excruciating pain from the site down my leg. I was unable
to walk more than a few steps. I was told this would be better in a
day or two. It is not better. I have had ultrasounds and CT scans of
my leg and all appear "normal". The only explanation my physician's
office has given is that they could have hit a nerve "or something" and
it "will get better eventually". I am unable to walk with the assistance
of a crutch and even then the pain is so bad I can only take a few
steps at a time. I would appreciate any suggestion or information.
Dee, Columbus, Ohio, USA, March 21, 2005
Has anyone had any complications from
the new Star Closure? This device is made by Abbott Lab and is still
being approved by FDA.
Shelley Bush, Coldwater, Michigan, USA, March 15, 2005
To all of you who have contibuted to this
informative site. Thank you. I am a cardiac nurse. As a nurse the stent
and angioseal and perclose companies constantly feed us that few, if
any complications arise. The complications of bleeding at the site
and internally are standard observations and management procedures
we are trained to deal with. The trouble with the closure devices is
a new area and the big companies pushing their wares tell me that complications
are NIL. We have just had an inservice on angioseals with a perclose
inservice soon. Your information will be forwarded to all of my collegues
in CCU and will assist us in our greater understanding. The Australian
Cardiac nurses are currently fighting to continue our specialty and
the companies pushing for complication free devices with early mobilisation
is a green light to governments and hospital management to decrease
CCU's and cardiac nurses jobs as these people buy the sales pitch of
these companies. Keep making a noise. I hope you all soon find good
health.
Julie S, CCU , Melbourne, Australia, March 13, 2005
Three days after a cardiac cath the Angio-Seal
device was used to close the femoral artery. I followed all directions
to the letter. However, on the third day severe pain began in my lower
abdormal area. The doctor saw me right away, ordered an emergency CT
with contrast. The results show a fluid sack about the size of a dime.
The physican tells me it is UNRELATED! Nevertheless, he further instructed
me to have blood work done (check RBC) and have the CT done over next
week. This site is soo wonderful. Are there other people who have this
type pain? By the way the Angiography reported negative for clogs.
R Pointer, Fort Washington, Maryland, USA, February 24, 2005
Hello I'm a 33 year old female who had
a angiogram and perclose procedure in 10/04 it was the most painfull
thing I have ever gone through in my life. my groin has hurt since
then I get pains into my leg and slightly into my lower abdomen it
just makes me cry...I have brought this up to my md a few times and
they don't ever say anything about it. I was in the ER for an anaphlatic
reaction 2 weeks ago I was coughing from bronchospasm the coughing
just about sent me through the roof with groin pain exactly where the
sheath had been and the perclose device was. I can't sit for more than
10 minutes or have my leg bent so that my groin has pressure on it
or I end up in pain. 2 weeks after the procedure I has us to r/o hematoma
or pseudoaneurysm and it was negative. I am also a critical care RN
I have a background in this area it is surprising to me Im in soooo
much pain. does anyone have any ideas or suggestions????
Dana Young, RN, Yakima, Washington, USA, February 06, 2005
I had a ANGIO-seal done. STILL HAS severe nerve
pain in right foot, leg, numbness. I AM WONDERING WHAT I CAN DO.
Alice, Rembert, South Carolina, Sumter, January 31, 2005
My 78 year-old father had Angio-seal after a
cardiac cath procedure. Three days after leaving the hospital he started
with reduced appetite, diarrhea. I took him to the hospital via ambulance.
I was told that he developed sepsis and passed away 8 hours later. Was
my father's death caused by the Angio-seal or some other factors?
Jacques Pierre, Brooklyn, New York, USA, January 30, 2005
Thank you so much for this site. I'm a 32 year
old male who had a procedure using angio-seal on my right femoral artery,
it has been 6 days and I am still in severe pain. I've had very little
swelling but extremly large brusing. I had an ultra sound done 2 days
ago and was told everything was ok, and to take tylenol for pain, what
a joke. I am now experenceing burning pain also in thigh area and low
back pain since I haven't walked normally since. Please email with what
was done about similiar problems.
Kevin Flynn, Brick, New Jersey, USA, January 26, 2005
I had an angioplasty done on 12/19/04 and it
was sealed with an Angio-Seal. I had a hemorage at the site and could
hardly walk, get up and down and couldn't even roll over without severe
pain for 2 weeks. I am still having problems but now they are pain in
my groin area and severe pain in my right thigh from my groin to about
8 inches into my thigh. I feel as if something is going to burst within
it. I have been back to the doctors who tell me that it's not from this
procedure. However I had NO problems with my leg or groin area, in fact
when they did the Angioplasty they found that my stress test showed a
false positive for a blockage. So now I am having all these problems
it seems for nothing and no one wants to acknowledge that I am even having
problems, the doctor keeps telling me that if it is anything it will
go away. My life is on hold because I can not even seem to function throughout
the day without getting back in bed to lay my leg straight out to relieve
some pressure. Anyone else have or heard of a problem such as this? I
do not know what to do other than consult another physcian. Any information
would be appreciated. Please write to cindiann0039@aol.com
Cindi Payne, Columbus, Ohio, USA, January 23, 2005
Had an angiogram on 1/12/05 very tolerable
with a small amount of vallium injected in my IV a little soreness today
1/13 but would have to say the most painful thing is removing the bandage
which they literally glue on.
Michael Ross, Placentia Ca , January 13, 2005