EM -- Sounds like a hematoma. If it isn't
growing in size or swelling, it probably will be reabsorbed over time,
but we would recommend calling your interventional cardiologst and
reporting it. He/she might want to look at it just to make sure.
Angioplasty.Org Staff, Angioplasty.Org, October 5, 2008
had a PTCA on 10/2 and they used a Mynx. Layed
flat on back first day no swelling or bruising. Next morning noticed
a line of purple bruising. By the end of the day there was a 3" x 1.5" line
of bruising to the left/medial to the incision site. Some swelling
as well, persistent pain and tenderness. Checked with the physician
on call and advised that it may be a hematoma. Bruising not getting
bigger nor is swelling. Worth a trip to the ER or not?
EM, Massachusetts, USA, October 5, 2008
Pain and numbness after angiogram. I had an
angiogram done September 22nd 2008 and have had pain and numbness down
my inner thigh since. I think the starclose has compressed my femoral
nerve! The inside of my leg was completely numb for 1 hour after I
stood up and dissipated 1 hour after that. 10 days later still occasional
sharp pains down inside of leg and incision site. Going to consult
with cardiologist. I'm guessing I'll need vascular surgery.
A Doctor, Missouri, USA, October 2, 2008
I am 49 years old and received angioplasty
in Feb 2008. I received the Angio-Seal Closure Device in my femoral
artery. The device did not "seal" properly and required pressure to
be applied at the site approximately 6 hours after the procedure due
to continued bleeding but other than that, I had no problems with the
product. I had a second angioplasty 6 days later where the traditional
pressure method was used. I was a bit concerned about the device getting
in the way or becoming unseated at the time of the second incision
and procedure but all turned out fine.
JTP, Kansas, USA, October 1, 2008
i had a heart cath one week ago.., they inserted
an angioseal... i consented because the nurse said it was easier recovery
and faster... well i have has persistant pain in my right groin area...
it hurts when i walk... i have horrible bruising 1/3 of the way down
my thigh... i went back today for a check up and the doctor did and
ultrasound and said there were no clots or anything for me go back
to work, to take tylenol and get on with my life... i insisted that
they pain is there and it gets worse the more i am walking on it...
i have even been running a fever... can you have an allergic reaction
to the seal? my doctor didn't seam a bit concerned about my pain and
now i don't know what to do? am i gonna be in pain during the 90 days
while this thing dissolves?
R Duffield, Summersville, West Virginia, USA, October 1, 2008
Suzan -- as for anti-inflammatories, what
about aspirin? Wasn't aspirin prescribed as an antiplatelet drug to
take with Plavix? As for drug coverage, check out our Forum Topic on Financial
Assistance for Plavix.
Angioplasty.Org Staff, Angioplasty.Org, September 29, 2008
I am a 56 yr. old who had the perclose device
used at my last 2 angioplasties (I have had 4 angioplasties and 14
stents, 10 of which are in my heart)). This last time they had to go
in on both sides of the groin. The closure on the right side was fine,
but the one on the left produced some pain. It wasn't at the actual
penetration site, but about 4 inches away and on the inside of thigh.
It was a burning sensation under the surface and almost felt like a
muscle was being stretched way beyond its limit. I mentioned it to
the cardio doc, but it didn't seem to alarm her. Only felt it when
moving a certain way. Anyway it got better in several weeks and disappeared.
By the way, my doc has forbidden me from taking motrin/advil/ibuprofen
due to increase risk of heart attack. Thanks doc, tylenol doesn't help
with inflammation! Also told to stay on Plavix for LIFE....losing drug
coverage 9/30/08....looks like I will be petitioning the drug companies
soon!
Suzan K., San Jose, California, USA, September 21, 2008
I had a Star Closure put on my femoral artery
during uterine artery embolization on Aug 4 08. The area had a bump
(pimple like) on it for the past month and a half. The bump started
to go away the last week and now I can see the star closure is actually
half way out of my skin. I know it is it because it is metal and star
shaped. I don't know what doctor to go see tomorrow. Any suggestions?
Back to the Interventional Radiologist? I did not give consent before
the procedure and was surprised when they handed me the info card in
my hospital room about the closure device.
Ellen, Georgia, USA, September 18, 2008
I work for a group of cardiologists and am
a former x-ray tech. I worked as a tech in the days when you laid flat
with a sandbag over the femoral artery puncture site for a minimum
of 6 hours. The angioseal seems like a great alternative. My husband
has had 3 catheterizations and I had my first one last April...all
closed with Angioseals. No problems until my husbands most recent.
He developed a staph infection (not MRSA) at the Angioseal that wasn't
properly diagnosed until it abscessed thru the skin and he was rushed
into surgery. He has been in the hospital for almost a week and I have
no idea what the long term prognosis is for his recovery. Those of
you who have had great luck, be grateful. There are those who have
had life threatening complications.
Karen, Oak Ridge, Tennessee, USA, September 14, 2008
It seems to me that if one puts the Angioseal
in too tight that it could tear the arterial wall and make a larger
hole than the original hole. If it is put in too tight the string might
break and send the inside flange embolizing distally. Of course these
are due to improper placement using too tight an application. The string
has to be very strong so it does not break and allow an acute embolization.
Joe Reynolds MD, MHMP, LLC, Bastrop, Louisiana, USA, September
13, 2008
I underwent a cardiac cath yesterday. I was
told during the procedure that the doctor was finished and about to
close using a star closure. When he completed the closure, it hurt
me greatly. The cath lab staff kept telling me to be still, and I was
trying. However, the pain was intense, not at the puncture site, but
radiating down my inner thigh to my knee. Now, I am 48 hours out, and
my inner thigh feels somewhat numb and my pain is getting worse. I
move my leg certain ways and the pain is terrible, again, not at the
site, but down the inner thigh. Anyone else experiencing this?
R. Stephens, Birmingham, Alabama, USA, September 12, 2008
LKG, see our
response from September 9.
Angioplasty.Org Staff, Angioplasty.Org, September 12, 2008
I had an angioseal placed after a cardiac
cath. I had no bruising immediately after the cath but then developed
bruising encompassing my entire groin and halfway down my thigh with
swelling in my inguinal area. Saw my cardiologist and he said that
this was normal. Cath was done in June, 2008 and I have been having
pain shooting down my thigh since. On occasion it is so painful that
I can not move. I am a very stoic person and do not know why this is
happening. Had an ultrasound today (OCT.) and my MD said it was normal.
He now wants to send me for an MRI if the pain does not resolve within
2 weeks with a regiment of Advil. Any responses will be greatly appreciated.
Maybe I should see a neurologist?
LKG, New Jersey, USA, September 9, 2008
Tom
Gillings of Australia writes (May 5, 2008 posting): "I am
50 and had a cardio-ablation 7 days ago. Used a Angio seal. And i
am going great, no problems. I think you yanks are a just a lot of
screaming wingers. GET OVER IT." Dear Tom: What is a "winger" (screaming,
or not?) Please reply to this post as there is a dinner riding on
a bet we made after reading yours of May 5 3008 (post).
Val, New York, USA, September 9, 2008
NZ -- if you
read through these comments and those in the related topic, "Complications
from Femoral Site During Catheterization, Angiogram or Angioplasty",
you'll see that you are not alone. This may be due to the femoral nerve
getting nicked or traumatized. This has little to do with the Angio-Seal,
but it sometimes happens during the femoral needle "stick".
It may go away in time. Some patients in these Forums have found help
by seeing a neurologist.
Angioplasty.Org Staff, Angioplasty.Org, September 9, 2008
I received an Angio Seal back on June 1st,
2008. I had the normal bruising and pain the first few days. However
within the first month or so, when I walked long distances, my right
groin area would hurt. Recently last month and again this month, approximately
a week prior to my menstrual, I have been having a lot of pain in the
right groin down to my leg and in my abdomen area and back. Prior to
getting the Angio Seal, I never experienced the issues with groin pain/leg
pain around menstrual time. Anything that I should be concerned with?
NZ, Colorado, USA, September 7, 2008
I had a angiogram in July 08. I have an angioseal.
It is suppose to dissolve in 3 months. I still feel it. This is my
crazy question. A few days ago it was really bothering me. I woke up
to go to the bathroom in the middle of the night and my foot was completely
numb. Is it possible that the angioseal blocked flow to my foot and
caused this? By the way I fell and broke my foot, can't walk on it
for 6 wks. It was just a really strange accident and the thought crossed
my mind that maybe this could happen. let me know if anyone has had
this happen.
Maddy, California, USA, September 4, 2008
I had the StarClose used on me during a cardiac
catheterization in Sept. 06 instead of the collagen plug which had
been used two years before. I was not aware of this until after the
operation and was informed by the Dr. that this was a "positive" change.
Since that time I have experienced pain in the lower right groin and
recently there are times of shooting pains that will take my breath
away. These are all at the site of the StarClose and when I told the
Dr. of this 2 yrs. ago I was told it would decrease with time....it
hasn't.
Terrie, New Jersey, USA, September 2, 2008
Hello, my wife had Uterine Artery Embolization
performed 23 days ago. Like many posting here, we were given the StarClose
pamphlet in the recovery room. We had no previous knowledge it would
be used. The first week went fine and the wound healed normally. Everything
seemed to be going in the right direction. The StarClose pamphlet stated
that she should experience soreness and tenderness for one week. Now,
23 days later the area is still very tender to the touch and she describes
a burning/stinging sensation (4 out of 10 on pain scale). There is
also a pea sized lump under the surface of the skin. She HAS NOT experienced
any numbness in the foot/leg as some describe, but the discomfort to
the puncture sight is constant. Can anyone tell us if this is part
of the normal healing process? Should the pain be gone or will it get
better? How alarmed should we be at this point? This is very demoralizing
for her to finally have relief of one problem only to have possibly
caused another. Thank you all very much for your time.
Jayme, San Diego, California, USA, September 1, 2008
I am 39 yrs. old and have a angio seal to
the right side of my groin, had no problems at the time it was done.
I went back to work 8 days later and that same day a bruise came on
my thigh about 3" to the right side of the seal. The bruise is about
2.5" long and 1.5" wide, deep purple in color, with some pain when
I walk and some tingling in my toes. Is this something that I should
be alarmed about? And what could have possibly happened?
R.M., Georgia, USA, August 6, 2008
I am a 48 year old female and I had a cath
5 days ago which turned out to show no heart blockage. The AngioSeal
was put in and I got up to walk in 1 hour. In 2 hours I should have
been going home and the pain in my back got so severe that I could
not stand up. A CAT scan showed a bleed with a 3x2 hematoma on my kidney.
I was admitted to ICU spent the night, more CAT scans and blood work
and I finally went home on Wednesday afternoon. I had to stay at a
vacation rental we own as we live in a stilt home and could not do
stairs. I am still there today. I am still in pain. The back pain has
let up but I have a strange pain in my lower abdomen not unlike cramps
which I am done with. None of these complications or this device were
discussed with me. I did not have symptoms and was not ill. There was
a shadow on a stress test after a one time A-fib event several months
ago that was stress related. I would not have had this done if I had
known about this risk. The only risk I was informed of was a stroke.
Elizabeth, Spring Hill, Florida, USA, July 26, 2008
As in any procedure there can be complications.
BUT I have had two Angiograms and both used the Angio seal and I am
so pleased with them I asked for them the second time around. they
are faster to seal and heal, you can get up walking faster and I do
not have to worry about an artery blowout. look into what you did after
the procedure did you rest the whole day? I know I did not and paid
for it with increased pain but a little rest and elevation did the
trick. now there are those who might have an adverse reaction to the
device as with any procedure/device but to generalize it with pull
it off the market NO I want the option of the best closure out there,
I an sorry your Doctor did not discuss with you the options but DID
YOU ASK him about the procedure and ALL the options I know I did and
it is my body and my health so I will ask all questions prior to a
procedure I have had an adverse reaction to morphine, so thank God
I ask about everything going into my body, when in the hospital with
my first cath and wearing a red warning bracelet about morphine a nurse
brought two syringes into my room to give to me and I asked "WHAT IS
IN THE SYRINGES?" had I not asked wow morphine...it is your health
ASK about everything ask the risks even on the table you have the right
to know and decide. look up the procedure unless it is an emergency
ask what will be used and read up.
Kevin, Arizona, USA, July 19, 2008
I last posted on to this site 12-12-07, following
an unsuccessful surgery to remove the StarClose that was put into my
body, without my knowledge or informed consent, on 3-8-07. My pain
did decrease substantially, but my leg and buttock are still deformed,
due to the device having cut-off blood flow. On 4-10-08 I underwent
a second surgery to remove the StarClose, this time with a fluoroscopic
table in the OR, and it was removed. I still have numbness from knee
to crotch; however, the surgeon says this will dissipate. The "so-called" doctor
who put this device in me was incompetent, thank God, and he hadn't
gotten near my artery! I feel very lucky in this regard. If you'd like
to chat about your experiences, e-mail me.
Iris Newbury, Ph.D., , Cypress, California, USA, Ph.D. (i.newbury@yahoo.com),
May 31, 2008
Had a false positive MIBI with a followup
angioplasty and they used the new StarClose vascular closure system
which basically worked fine. The problem came when the bill came; I
was charged $1596 for the device! That sounds like egregious highway
robbery; they come in boxes of 10 units - maybe I paid for all ten!
Bob, California, USA, May 9, 2008
As a healthcare professional, 53 years old,
I had a heart cath due to a positive stress test. I just happened to
be going to the cath lab , the same day a rep. was demonstrating the
latest and greatest device, called a starclose. My heart cath was negative
the starclose was deployed. During the deploying of the device, and
although I was still under the influence of versed, I felt 2 very painful "pinches".
Since my procedure, 10 months ago, I have had progressively worsening
of intermittent, right groin pain. The last episode was 5 days ago,
and I almost called 911, it was that intense. I assure you I am not
a cry baby or wimp. I do not even know if the severe pain is due to
the device. All I know is I never experienced it until I received the
star close and other than some allergies to environmentals, I am essentially
healthy. I truly believe this object left in my femoral artery is the
blame for my discomfort.
M.G., Registered Nurse, West Virginia, USA, May 8, 2008
I am 50 and had
a cardio-ablation 7 days ago. Used a Angio seal. And i am going great,
no problems. I think you yanks are a just a lot of screaming wingers.
GET OVER IT.
Tom Gillings, Comment maker, Australia, May 5, 2008
The pain may not have anything to do with
the Angio-Seal, but most certainly has to do with something related
to te catheterization -- perhaps nerve trauma that occurred during
the femoral (groin/leg) artery catheter insertion. Definitely discuss
this with the interventional cardiologist. Let us know how you fare.
Angioplasty.Org Staff, Angioplasty.Org, May 4, 2008
I'm a 43 year old mother. I had the Angio-Seal
7 days ago. I'm having so much pain in my leg and now it seems the
pain is moving up. The pain rate is a 7. I can't stand up and walk.
The pain gets so bad i can't stand it. The nurse in the hospital said
5 days bed rest and walk after that. That's what i done now i want
to cry at times from the pain. What do i do?
Rose, Alabama, USA, April 29, 2008
Rebecca -- if bleeding from the femoral artery
continues after discharge from the hospital, definitely call the interventional
cardiologist who did the procedure or other healthcare professional.
About 3 patients out of 100 experience complications after a catheter-based
procedure that uses the femoral artery. Bleeding is the most common
complication. A hematoma or purplish bruise that is growing in size
is a signal that some bleeding is occurring under the skin (subcutaneous)
-- if the bruise is not growing, then the bleeding has stopped -- the
bruise will disappear in time as the body absorbs the blood (this is
not unlike getting a "black eye"). All the angio-seal does
is stop the bleeding sooner, using a collagen plug which is absorbed
into the body over the next few months. But complications can occur
with or without these devices. If you suspect anything, call the cardiologist.
Angioplasty.Org Staff, Angioplasty.Org, April 28, 2008
My mom just got a Angio Seal about three days
ago.... There wasn't supposed to be any bleeding or bruising. The hospital
gave us a book to keep for 90 days. One thing I'm concerned about as
a 15 teen year old is that is the bleeding supposed to continue?? And
will the bleeding stop? Nobody informed my mom that the Angio Seal
is a device... my mom read these comments and now is worried. She scared
that something could happen. I'm worried about my mom and who should
she see about this????????????
Rebecca, New York City, USA, April 27, 2008
I am a 54 year old female that had the Angio-Seal
device implanted in me in May 2005 following a angioplasty.The cardiologist
did not discuss this with me before the procedure, or ask my permission,
it was just done. I was absolutely horrified to read the information
saying these devices were NOT to be used on people who were auto immune
suppressed. Well, the cardiologist was super busy in the cath-lab that
day so he had his P.A. do the pre-op physical. They simply were too
busy, they over looked my terrible psoriasis on my right leg. The P.A.
said my skin was clear. WRONG. I have had terrible right leg pain ever
since. The worse thing is I have chronic yeast infections every three
to six months now, which I have to take medications for. This likely
will go on for the rest of my life.The cardiologist was supposed to
put a stent in for my clogged artery, but decided not to. Thank God
for that. I for one have had nothing but problems ever since they used
this device (Angio-Seal) to close my femoral artery. I personally think
they should be pulled off the market, before they ruin any more lives.
They used these to do more procedures and make more money. Really they
don't have the time to just stand there and hold pressure,(that's considered
the old way.) The bottom line is they use these devices because they
can make more MONEY by doing more procedures. I have filled out the
form on the FDA website and I recommend anyone else having problems
do the same. They have to know by now. Something should be done. My
cardiologist is so busy doing these procedures he does not have time
for follow up visits. I have been rescheduled eight different times
in four months. He knows he messed up now he does not want to hear
my complaints. I am going to get a lawyer and do something about this
if possible.
Kathy S., Illinois, USA, April 26, 2008
An angio seal was used on me after a negative
result heart cath. I developed swelling that first night home and it
became worse the next day. I went to the E.R. and the bruising and
edema were even more worse. At this point..the doctor had a ultrasound/doppler
of the groin. They told me it was a large hematoma and to keep an eye
on it. I was afraid that something was going to break loose and go
to my heart. I missed two full weeks of work,and still have to apply
a heating pad to the area at bedtime. The stiffness kills me and my
entire leg wants to fall asleep at time, like my circulation is being
disrupted. It's been 2 1/2 months now with these ongoing symptoms ....
I wish they would have never placed it in my body. I had no clue that
they were even going to use the stupid thing. It still feels too big
for my small leg artery, but I can't do anything about it now...best
wishes to all...
T.L.B., Ohio, USA, April 22, 2008
To
R.F. in Maine posting USA, March 2, 2008 concerning your angioseal.
I have had very similar reactions with my Nitinol Star Closure Device.
It turns out that I am allergic to the materials found in the device.
What you are experiencing may be an allergic reaction. My activity
level seems to be directly related to the severity of the reaction.
My daily ritual of meds are 1 Allegra a.m. 1 Benadryl afternoon 1
Allegra mid-day 1 Benadryl mid evening and then 2 hydroxixine at
bedtime. Try taking Benadryl and ice the area. If you get any relief,
however small, yours maybe allergy related too. I will be having
surgery to have this device removed within the next 2 weeks. I will
post after this surgery.
E.S., Dallas, Texas, USA, April 14, 2008
The last two postings show the range -- they
are both about the StarClose device, one describes a serious complication
and the other discusses how much better the StarClose was than the
first conventional closure. Complications are relatively small in number,
but it is not small when the complication happens to you.
What the medical profession does is look at the big
numbers. Does one closure device have a significantly larger complication
rate than others? How does it compare to the complications seen with
conventional manual pressure? A few years ago, an analysis of the NCDR
Registry did just that and found
that the VasoSeal device was associated with a greater complication
rate -- this data analysis caused the device to be withdrawn from
the market. We urge all patients to post their experiences here (for
all to read) but also to file
a formal report with the FDA, if they experienced a complication.
Hospitals are supposed to file these reports, but they don't always.
Angioplasty.Org Staff, Angioplasty.Org, April 12, 2008
I am a 26 year old mother of 2. I recently
had an angiogram (2 weeks ago) and when the procedure was done I had
the "normal" applied pressure and was closed up and sent to recovery...waited
the 4 hours and was sent home. The pain for the next two weeks was
horrendous. At the end of my two weeks I was scheduled for the Gamma
Knife for the second time in 7 years. Part of the procedure is a angiogram
(again) I believe because of needing to be able to go back downstairs
for immediate continuation of the procedure I was given the *starclose*
as opposed to waiting for the conventional closure waiting time. I
had the Gamma Knife and later was given the pamphlet about the starclose
and barely remember being told I was receiving it only hearing what
sounded somewhat like a staple gun clicking about four times. After
reading all of these entries about negative responses I have to say
I so far feel that the recovery is MUCH better than the first angio
where I had regular closure and the waiting period when I felt sooo
much pain following...I couldn't walk and my legs were numb for t weeks...with
the *starclose* I feel slight discomfort and a lil rockish feeling
at the sight but not much more. I did just have four screws in my head
and the pain may be more concentrated there so I may not be feeling
my leg as much but it is definitely not as bad as it could be. I am
also usually not able to take the time to recover as I should be the
mother of a five year old and a five month old. I feel bad that there
were soo many bad experiences with these devices but I only had it
done on Fri April 4th, 2008 and it is now Tues...sooo far soo good!
So it is not all bad. I think everyone heals differently and everyone's
body handles and accepts or denies things differently as well. I am
hoping that things remain in good standing for me with this but good
luck to the rest as well.
J. Johnson, Pawtucket, Rhode Island, USA, April 8, 2008
I had a cardiac catheterization on Nov. 19,
2007. I had not been informed before, but a Starclose device was used
to plug the femoral artery. After procedure I started having pain in
my right leg after walking 50-60 feet . Further tests confirmed that
Starclose is blocking my artery . I had a very serious operation to
remove Starclose and repair my artery. After 2 months I still have
pain . I have a bare-bone insurance, and this unexpected repair operation
cost me a small fortune. Is it the fault of doctor performing catheterization
or is it a faulty Starclose device ?
K. D., New Jersey , USA, April 8, 2008
To the two Lizes -- Liz from UK -- the bruising
is called a hematoma and comes from bleeding under the skin -- it usually
disappears, but if it hasn't or is growing, and if the pain you're
having doesn't resolve, definitely discuss this with your interventional
cardiologist.
Liz from Florida -- we're sorry to hear of your problems.
It's also possible that the damage to the femoral artery was caused
by the cath itself (needle puncture, etc.) and not the closure device,
but suffice it to say, it's one reason we have been trying to educate
patients and doctors on the use of non-invasive CT angiography for
diagnosis, where appropriate, especially to rule out coronary disease
(it is excellent for that) and also to promote knowledge about the
radial approach, where the wrist artery is used instead of the femoral.
Not appropriate in every case, but has been shown in study after study
to singificantly reduce access site complications.
Angioplasty.Org Staff, Angioplasty.Org, March 31, 2008
My heart cath was three years ago, an Angio-seal
was used. The femoral artery was damaged which has required two by-pass
surgeries. I also had a staph infection that took months of home IV
care to clear. The numbness and pain are still very problematic. I
gave up on pain management two years ago and simply live with the pain
and limitations imposed on my life by a medical product that should
have been recalled years ago. A compression stocking helps a bit on
the really bad days. My cath was clear, no problems (my teenagers were
stressing me out!). I am 44 years old and now have to wonder how long
my by-pass will be functional. I am terrified of going through another
femoral by-pass, but have been told that 10 years is about average
for by-pass expectancies. I wish I had never used the Angio-seal and
I strongly suggest that compression is used over ANY closure device.
This is very important in woman with small veins, stature and is clearly
indicated on the instructions of all closure devices. I guess the doctors
prefer quick ambulation and the extra profit over the well-being of
their patients.
Liz W., Florida,USA, March 27, 2008
I had an angiogram followed by the insertion
of an angioseal 10 days ago. I was told there would be a small amount
of bruising and a little lump at the insertion site. Half of my right
thigh is black and blue and there is a pain not unlike a torn ligament
which runs from my groin nearly down to my knee. I also have a dull
ache across my lower abdomen.The lump itself is hard and painful and
yesterday my lower back went into spasm on that side. I am having great
difficulty sleeping as the pain wakes me every time I move. Any idea
how long this is likely to carry on?
Liz, United Kingdom, March 26, 2008
I had a a angiogram a few days ago. Afterwards
I found out they used an Angioseal & I am not happy about it. If I
had been given a choice between nothing being left in my vein & the
angioseal I would have chosen nothing. Now I am constantly worried
that something is going to go wrong or a piece is going to separate
and go drifting through my blood stream. The only reason, as far as
I can tell, that they used the angioseal is so I could be discharged
about 3 hours faster. Of course now I have to worry for 90 days that
something will go wrong. I would have gladly stayed overnight so that
I would not have to be burdened for 90 days worried about this thing.
To say that I am pissed is an understatement.
S.D., Kentucky, USA, March 21, 2008
All of you who are having issues related to
an internal closure device, please accept my apology that you were
treated with one with no informed consent. It is an unexplainable phenomenon
that eludes me (a cardiac nurse) why patients are not informed of the
risks associated with the devices. There is an option to closure devices
called Syvek (www.syvek.com) Very safe and nothing is left behind.
Ask your physician about this topical device as an option. If he/she
has not heard of it and it is not an option, demand manual compression
with gauze. It takes longer, but does not have the risks as internal
closure devices do. I wish the best to those of you with complications
for a speedy recovery.
K.N., nurse, Ohio, USA, March 14, 2008
I had a heart cath in 2002, they used an angioseal.
The day after I had sharp shooting pains into my abdomen. I went to
the ER and had a doppler which they said was fine. I almost passed
out from the pain when they were up higher than the site. I was unable
to straighten up to walk since the pain was so severe. I went back
to the ER after a few days and they finally did a CT scan. They found
a retroperitoneal bleed. I was hospitalized for two days. My problem
now is that I am having increasing right groin pain radiating into
my thigh after I have been walking for awhile. Sometimes it goes clear
down to my knee. I am wondering if this is from scar tissue at this
late date and who I should see about this?
Cherilyn S., Illinois, USA, March 7, 2008
Carol Ann -- as you can see, your story is
unfortunately not unlike many others posted in this topic and the related
topic in the right column, "Complications
from Femoral Site". So many patients write in that they've
been told there's nothing wrong -- except they are experiencing significant
pain, right where the catheterization was done.
First of all, this may or may not have anything to
do with the AngioSeal, which is a just a closure device for the femoral
artery. It may have to do with some type of complication that occurred
around the femoral artery access site -- for example, sometimes the
femoral nerve (which lies parallel and close to the femoral artery)
gets traumatized or pinched during the needle stick, or the closing.
Sometimes this pain does go away. Some patients have had success seeing
either a vascular surgeon or even a neurologist. One reason that physicians
say nothing is wrong is because they have no way of seeing or measuring
something (it's just your word...). But a neurologist actually can
run a test to see if there's nerve involvement causing the pain. Good
luck and let us know how things turn out.
Angioplasty.Org Staff, Angioplasty.Org, March 2, 2008
In November of 07 my dad had an angio-seal.
He has had terrible pain in his right groin area ever since and has
gone back once to the doctors whom did the procedure and was told there
was nothing wrong. He also saw his PCP and was told there was nothing
wrong. Just about two weeks ago one of his doctors passed away and
now we are really in a bad place. I am very concerned because he has
such severe pain he can hardly walk at times and sleeps less and less.
On top of that he worries a lot about it and that doesn't help the
situation at all. Please help me!! I am willing to share any and all
information I find if you all will please do the same. I need to find
a doctor who will help.
Carol Ann, Kansas, USA, March 2, 2008
R.F. -- did you begin any new medications
at the same time? Some drugs, such as Plavix, can have this effect
-- however, DO NOT stop taking any drug without consulting your cardiologist
-- it can be harmful, especially if you've had a stent placed.
Angioplasty.Org Staff, Angioplasty.Org, March 2, 2008
I'm eight days out
from receiving the angio-seal. I just started getting rash on my right
leg (same side) abdomen and left leg. Anyone have this problem and
should I be concerned?
R.F., Maine, USA, March 2, 2008
To the person who sent in two extensive postings
to this topic, with the initials J. E. T., your comments are most interesting
and you obviously spent a significant amount of time writing them,
but your email address is invalid -- there is no such domain -- and
we have a strict policy of not posting any comments unless they have
been sent from a valid email address. Please contact
us and we will post the comments.
Angioplasty.Org Staff, Angioplasty.Org, February 28, 2008
Just to let you all know..there is a new closure
device called "Boomerang Catalyst" out there. It allows you to walk
sooner, in two hours, all while leaving nothing behind in your vessel.
Check it out on-line. There is no risk with this device as there are
with devices that stay in your vessel. If you are looking for a more
natural method to closure, this is it!
R.K., Ohio, USA, February 18, 2008
On 01/21/08, I underwent a right femoral angiogram
and a Angio-seal device was used to plug the artery. As of 02/04/08,
I have had no bleeding and very little soreness. My job requires lifting
up to 100 lbs. from ground level. Any thoughts as to when/how long
I should wait before returning to work?
Joe E., Arizona, USA, February 4, 2008
I had a cardiac cath done on 2.1.2008 and
had an angioseal put in without my knowledge. I've had a cerebral angiography
done a yr and a half ago and I was not in pain like I am right now.
Why is that?
Grace, New Jersey, USA, February 2, 2008
The FDA has recently approved AccessClosure's
Mynx Vascular Closure System. Are there any thoughts about this replacing
Starclose and Angio-Seal? Has there been any complications reported
from the Mynx device? Thanks in advance.
Tom., New York, USA, January 27, 2008
Unless I am wrong patients should be advised
that using any closure device should not be billed as it is part of
the procedural package. The choice to use any one of the devices is
certainly debatable; one over the other or none at all. I think I would
prefer a pretty nurse apply pressure to my groin than rely on a controversial
device. My point is closure is closure and is part of the cath or surgery
or injury.
P., Georgia, USA, January 11, 2008
Byron -- this forum topic is only about problems
(or not) with vascular closure devices, something you should discuss
with your cardiologist. As to your specific situation, it sounds like
you have what is known as a "total closure". This is a topic
of great discussion among interventional cardiologists and surgeons.
There are questions and debates over whether it is beneficial to open
a totally blocked artery, especially when it is well-collateralized.
An important piece of information is whether or not the part of the
heart muscle supplied by this artery is being under-perfused, that
is, getting less blood flow/oxygen, than it requires. If so, increasing
that may be of significant benefit. It's a complicated situation, and
we would recommend discussing this more with your cardiologist. By
the way, normally a cardiologist would not be doing the bypass surgery
-- that would be performed by a cardiothoracic surgeon.
Angioplasty.Org Staff, Angioplasty.Org, January 11, 2008
After reading this forum, I am very reluctant
to go ahead and get angioplasty. There are so many negative comments
about it, I just got diagnosed with at 100% blockage in the right artery
and the 64ct showed that collaterals are giving me the chance to live.
The cardiologist says he will try the stent placement, if not possible
through the angioplasty he will then do the minimal invasive bypass.
I am very concern now if I should discuss with him all these bad experiences
described here and go straight to get a bypass.
Byron, San Fernando, California, USA, January 11, 2008
Scott -- you've hit on one of the reasons
hospitals use vascular closure devices (there are a number on the market).
It's called "early ambulation" -- the patient can walk sooner
and thus, in an uncomplicated case such as a diagnostic cath, there
is no overnight stay involved. The sandbag method requires extra nursing
time, discomfort, etc. as well. The swelling should go away, but we
urge you to talk to your cardiologist (the one who did the cath) if
this does not resolve. Too often, the doctors doing the procedures
never get the feedback from the patient.
Angioplasty.Org Staff, Angioplasty.Org, January 11, 2008
I had the Cardio Cath procedure on the 20th
of Dec and they found no blockage and all went well with the exception
that the Dr was late (Instead of the procedure beginning at 10AM --
I went in around 6pm) and I wasn't given the options for closure devices
or traditional manual pressure and I had the Star Closure. This feels
like a little rock under the skin, hurts when running if I take long
strides, and areas around it are extremely sensitive. I asked about
having this removed and was told I'd have to see a Vascular Surgeon
and it was extremely risky. What are my options and is there a way
to explain why a doctor would use this as opposed to the traditional
sandbag on the groin for 4-6 hours? My impression was the lateness
of the doctor lead to the need to use an expedient closure to prevent
my required long term stay (Potentially overnight given the hour of
the eve when the procedure was completed 7pm).
Scott , Tampa, Florida, USA, January 11, 2008
Stephen -- thanks for writing in. We host
these Forum Topics, but we try to emphasize that all the various complications
described here and in other threads are a small minority of cases.
This is not in any way to minimize some of the pain and suffering caused
by these complications, but it's a reminder that they only occur about
3-4% of the time. The great majority of patients have an experience
more like yours. That being said, raising the issue and the type of
complications is an important task -- and patients have very few "forums" to
communicate these stories.
Angioplasty.Org Staff, Angioplasty.Org, January 11, 2008
I am a fit 65 year old just out of hospital
after my seventh angiogram -- four of these were for stents. I have
always been fine post ops, and the angio-seal has always been fine
with just a bit of soreness and a small lump for a few weeks slowly
disappearing.
Stephen M Bishop, U K, January 10, 2008
Terry -- the Angio-Seal is a temporary seal
-- holding the puncture site in the artery together, not unlike a band-aid,
to prevent bleeding. When it has done its job, it (usually) is absorbed
and no further seal is necessary because the artery has healed.
Angioplasty.Org Staff, Angioplasty.Org, January 8, 2008
I had an Angio-Seal vascular closure device
inserted in my femoral artery, about a month ago. I was given a leaflet
about the device, which says that "The device is absorbed within 90
days of placement". If this is the case, what happens after 90 days
- do they have to insert another one - or a more permanent one?
Terry Slattery, Spain, January 6, 2008