FYI: Contrast dye for echos!

US FDA to alert doctors about imaging drugs' risks

Source: Reuters
Author:
Date: Tue, 9 October 2007
US regulators will soon alert doctors about reports of deaths and serious reactions following the use of certain imaging agents to help diagnose heart problems, Food and Drug Administration officials said recently.

The contrast agents, Bristol-Myers Squibb Co's Definity and General Electric Co's Optison, are injected into some patients' veins before doctors view the heart via an ultrasound procedure known as echocardiography.

The FDA has been investigating reports of deaths and serious cardiopulmonary reactions after people were injected with either of the products, FDA spokeswoman Karen Riley said.

"The agency will soon be issuing information to health care professionals to alert them to these serious risks and to provide guidance regarding the safe use of this contrast agent," Riley said.

The FDA also has asked the manufacturers to update the product labels and the companies have agreed, Riley said.

The Wall Street Journal, which first reported the FDA plans, quoted unnamed sources saying the products were expected to carry a 'black box' warning, the strongest type for medical products. Riley said she could not say whether the FDA had requested a black box for the information.

Definity had 2006 sales of about $65m. Optison was recalled by GE Healthcare in November 2005 because of manufacturing problems. The company said last month it hoped to relaunch the product this year in September or October.

The products are made from gases enclosed in tiny capsules of protein or fatty material. They can help doctors visualize the borders of the heart more clearly and identify abnormalities.

Millions of people have echocardiograms each year, but only a small group of them receive Definity or Optison, FDA spokeswoman Julie Zawisza said.

Bristol-Myers spokesman Tony Plohoros said the company was in discussions with the FDA about label revisions for Definity "and will communicate them as soon as they are final." The product's 2006 sales were about $65m.

GE Healthcare also is talking with the FDA about changing the label for Optison, spokesman Brian McKaig said.

"To date, more than one million doses of Optison have been given and very few adverse reactions have been reported," he said.

(Reporting by Lisa Richwine, additional reporting by Bill Berkrot in New York and Scott Malone in Boston)

Comment: I had an echo two months ago and technician wanted to use contrast dye, but I refused as I had an MRI scheduled that afternoon, also with contrast dye (and that's another story).

[chrisy]

HA!

I don't think I shared this, but my last echo was a nightmare. Rather, the tech was a nightmare. She was mad at me before I even walked in (because she had studied up and learned I was "technically difficult" because I have a left implant).

Well, it went downhill from there, she bitched at me nonstop throughout the whole procedure, with highlights including I should go get it done somewhere else, I SHOULD GET IT WITH CONTRAST and, my favorite, "If I ever got diagnosed with cancer, I'd just accept that that's the way I'm going to die and wouldn't get all that treatment".

Although I made a note in my book to NEVER get that tech again, I'd love to wave this in her face! Of course she'd probably just see that as an advantage, put me out of my misery sooner LOL~!

Chrisy,

How awful! The technicians and doctor were very nice at mine although a bit too insistent about using contrast. I'm glad I refused, although I did so mainly because I knew I was getting contrast later that day and my veins were not holding up well. Contrast in afternoon was really awful as the dye leaked and caused lots of burning and pain.

Definitely avoid that technician, and yes, bring the article along. Best.

[Mary Anne in TX]

Chris, even ol' miss "find a blessing in everything" would find it difficult to find the blessing in that goofy person! What a jerk! Oooh, did I say that! Yes, she's out of place in this world we bc folks inhabit! I had the brain mri the other day with and without contrast dye. The young men, technicians, must have asked me two dozen times if I had ever had it before and was I allergic and did I know how I would react. Did I know what to do to avoid problems, etc. They were incredible. I guess that's why I go there though. And the good part is that my insurance for the first time has agreed to pay 1/2 of the cost! Yippee! I may get that Christmas vacation this year after all. Used vacation money to get scans, mris, etc the past 2 years, but it was so worth it. I don't encourage others to do that, but my fear level gets so over the top that just knowing how incredibly kind they are at this place recommended by my onc makes it so much easier.
That lady makes me really mad! I do believe that "what goes around, comes around"! She'd better shape up!
Well, enough of that. I'll get that blood pressure up for sure!

[Sandy in Silicon Valley]

Hi, Chrisy,

Oh, yeah - your echo tech sounds like a doozie!!! You might consider (if you have nothing better to do - haha!) writing a letter to the hospital/clinic where you got the echo done, and reporting that tech's behavior - especially what she said about "if I had cancer..." Who asked her, anyway???

Once upon a time, back when Stanford was still using its antiquated MUGA machine, I was assigned to a tech-from-hell. She kept up a steady patter of TMI about the test, the machine, the contrast dye, etc. - but when I complained that the exercise stationary bike she had me on was twisted in an awkward manner, to drape my left arm up over the MUGA scanner, she said "No, it's not!" I finally had to refuse to try to strain my arm up behind my head to reach over the barrel of the machine, before she (grumpily) told me to get off the bike, and, grunting and groaning, repositioned it better for me. After that, she continued to behave insufferably. I'm sure that my bp was through the roof by the time I left that test!

So I went to the reception desk, asked for the name of the physician in charge of the department, and went home and wrote a detailed letter, documenting the tech's numerous missteps, and my feeling of having been mistreated and disrespected as a patient.

I got a letter back in a few weeks, from the Chair of the Dept., apologizing for my experiences, saying he was new, and trying to "correct longstanding problems", and promising that I'd never have to deal with that tech again.

I actually did get assigned to her last week, over 3 years later, when I went for a bone density test - but I don't think she recognized me, and other than the unsolicited TMI patter, she was polite and respectful. I kind of hope that she got read the riot act, way back then, due to my having complained, and maybe cleaned up her act, or got some remedial people-skills training - but even if that's not the case, I'm glad I made the effort, and got my grievances off my chest.

(((hugs)))
Sandy in Silicon Valley

[Andrea Barnett Budin]

First let me say I'm confused. I have been getting ECHOs since '98 on a reg basis and I have never had contrast. One MUGA in '95 at initial dx yes. So, I don't understand ECHO and contrast. CT SCAN -- contrast yes. Brain MRI -- CONTRAST yes. Not w/ECHO ever.

Now Chrisy -- that tech should be placed under arrest for assault! I'm not kidding. I know I've gotten griping over the difficulty one has when the patient has a tram flap reconstruction, but in a good natured, Now this is a real challenge kind of way. One tech was motor mouth *bitching* all the while. I never heard such a negative attitude, and relentless at that, w/ a nurse, tech, even receptionist. I never returned to that facility.

The last tech told me -- It's not really a challenge if you know what you're doing. She was a 20 yr vet and the loveliest woman. Intelligent, sensitive and efficient.

The If I ever had ca comment, Chrisy deserves a letter as Sandy suggests. You want to save another ca patient from ever having to be affronted by such a hideoously insensitive inhumane being! I am seriously appalled. A letter is in order. I've done it (pre bc, when in hosp in Huntington, Long Island).

AND, I wrote a letter of commendation about a tech who was so extraordinarily caring that she blew Paul and me away. (I'd just come to Fla full time, had my 1st CT scans here, had my 1st different drink to drink. I went home, waiting for results. I go 1st appt so I can get a SAME DAY REPORT. They called me around 3: and said I needed to come back in. They couldn't read the scans. So I went back in. And drank another drink. And waited. And they still could not read the scans. Bowel loops or something. Keep in mind, I get major diarrhea from the 1st drink for 3 days. More to drink. More waiting. No can read. It's now 5: THEY CLOSE. Every one was leaving. You need to come back tmrrw. NO. I CAN'T DO THAT. THE ANXIETY WAS PALPABLE for both Paul and me. I said, I don't understand. I've never had a problem before. I've been doing this for a yr in NY. But I drink a different drink. What do you drink. Oral Hypaque. Wait here. She goes and comes back. There was no O.H. at the Pavilion, but she'd called and checked and the Hospital had, and she was going to walk over (5 min.) and get it. She also checked w/the radiologist who agreed to stay late. And it all turned out great. Except for the diarrhea of course... So I wrote a letter to let them know how extraordinarily wonderful this tech was. But it works both ways. When you get an offensive nasty cold-hearted and cruel person -- it is your responsibility to report them. To save others from being faced w/such a dismal and crushing person.
Andi

Andi--Contrast dyes are also used in echos if pictures are not sufficiently clear. However, recent evidence (as indicated in article that I posted) shows that echo contrast dyes can cause serious problems. There is also evidence that MRI contrast dyes can also create problems, as indicated in Mary Anne's post.

[BonnieR]

Christy, that technician needs to be reported. Really. How dare she say such a thing?

[Alice]

I have also had many Echo's and have never had contrast. I had forgotten that they do this on occasion when the echo is particularly dirricult to read. As a vet tech at a specialty hospital we used to do a contrast on occasion with echo's and also with some kinds of kidney studies. This was abandoned due to the unnecessary risk for the patient. I do not know what the correlation to the risk in humans is. It may be that the information is more critical to the human health system. I also have never had a MUGUA. My onc was satisfied with the echo's as was I. I have difficulty with any kind of contrast dye, I have onr kidney and the dye is hard on it.
Alice

[Andrea Barnett Budin]

Thanks, Grace, and all. So ladies, I'm going to be scheduled for a brain MRI (it's been a yr) and I'm wondering if I should NOT get the contrast. What do you think?

Last yr my insur co only approved the MRI w/o contrast -- and IF they found something suspicious, then they would approve another MRI WITH contrast. The report said unremarkable but stated it is very difficult to find evidence of metastatic disease w/o contrast. So it was inconclusive to me. My onc thought for a sec and then decided, "It's a Catch 22", shrugged and said not to worry about it.

In my case, he feels that if I were going to have brain mets they'd occur closer to my recurrence (in '98) and not at this point. I think he thinks I'm indestructible. He just keeps telling me, YOU'RE VERY LUCKY!

My husband says if I were really lucky I wouldn't have ever had bc. But I disagree. I do feel very lucky.

Meanwhile, what do I do about upcoming brain MRI?? I welcome any comments or thoughts any of you incredible ladies have...

Thanks,
Andi

[Lani]

such as if there is a shunt or hole between one part of the heart and another
causing the heart to beat less efficiently (a very rare structural problem that would have been present since birth or after a heart surgery)

I may be wrong, but I was told this by a very experienced echo technician who is involved in research and was one of the earliest adopters of the 3 d echo machines at Stanford(most institutions only have 2d machines). Stanford does lots of congenital heart correction operations and heart transplants as well as valve replacements and repairs, so their echo department is very active.

As the echos in patients getting herceptin only need to give an accurate percentage regarding the fraction of the blood volume of the heart that is ejected with each heart beat (ejection fraction) and particularly of the left ventricle (although someone here posted they had right heart problems on herceptin--this is very basic information easily derived and with no necessity to use the contrast dye.

So as far as I know, this is one concern one can be spared!

There are so many things to be worried about, it would be nice if there were one less.

Again, I am not a cardiologist and am only reporting what I have been told--if I recall RobinP used to be a cardiacICU nurse at Johns Hopkins.

Perhaps she can share some of her expertise with us.

Lani, if you're correct, then Mt. Sinai was particularly negligent in trying to use contrast dye during my echo, as its purpose was to determine if my LVEF was still in normal range. I was having another test in the afternoon and was concerned about having two contrast dye injections in one day so refused. Just another reason for all of us to be vigilant in our own care. I'd be curious to know if what you write is correct. If it is, I intend to follow up with my cardiologist to find out why contrast dye was suggested for my echo.

Andi, there can be issues with MRI contrast dyes, but from what I've read it's usually with those who have kidney problems. You can read up on it via the internet. I know that drinking lots of water, particularly after the test, is advised.

[Andrea Barnett Budin]

Thanks Grace. I will search. I know about potential problems. I have a cyst in my right kidney that they've seen for yrs. If I twist around funny, like from the front seat of the car, to talk to some one in the back seat, I get a sharp breathtaking pain right there. So, consequently I am mindful about twisting.

They have visualized a stone from time to time in my left kidney. I passed one huge one in '80. Then they see nothing, so I'm assuming it crumbled and came out as dust or whatever. I drink 10-12 glasses of water a day. Every single day. My urea BUN is commonly elevated. I ask why, they tell me to drink more. So do I have kidney problems, not really, but... Hmmm...

Andi

[Lani]

Bidimensional real-time echocardiological visualization of a ventricular right-to-left shunt following peripheral vein injection.
Eur J Cardiol. 1977; 6(2):99-107 (ISSN: 0301-4711)

Serruys PW; Vletter WB; Hagemeijer F; Ligtvoet CM

Contrast techniques were used in the echocardiological evaluation of a 28-yr-old patient with congenital cyanotic heart disease; catheterization showed an association of an atrial septum defect, a ventricular septum defect, and a patent ductus arteriosus, with equalization of pulmonary artery and systemic pressures. Glucose 5% in water, injected as a 10-ml bolus into an antecubital vein, constituted an adequate echogenic contrast solution. The heart was examined with both a single-crystal transducer (echoes recorded in M mode) and with a 51-elements dynamically focuses multiscan system (echoes recorded on video-tape). Contrast echocardiology showed that right-to-left shunting occurred at the level of the ventricular septum defect and was not significant at the atrial level.

[Lani]

Bidimensional real-time echocardiological visualization of a ventricular right-to-left shunt following peripheral vein injection.
Eur J Cardiol. 1977; 6(2):99-107 (ISSN: 0301-4711)

Serruys PW; Vletter WB; Hagemeijer F; Ligtvoet CM

Contrast techniques were used in the echocardiological evaluation of a 28-yr-old patient with congenital cyanotic heart disease; catheterization showed an association of an atrial septum defect, a ventricular septum defect, and a patent ductus arteriosus, with equalization of pulmonary artery and systemic pressures. Glucose 5% in water, injected as a 10-ml bolus into an antecubital vein, constituted an adequate echogenic contrast solution. The heart was examined with both a single-crystal transducer (echoes recorded in M mode) and with a 51-elements dynamically focuses multiscan system (echoes recorded on video-tape). Contrast echocardiology showed that right-to-left shunting occurred at the level of the ventricular septum defect and was not significant at the atrial level.

[Lani]

Contrast echocardiography in two dimensions and in real time. 2. Clinical applications]


Arch Mal Coeur Vaiss. 1978; 71(6):611-26 (ISSN: 0003-9683)

Serruys PW; Hagemeijer F; Bom AH; Roelandt J

The anatomical and functional abnormalities which are the basis of septal defects and valvular incompetence can be visualised directly by two-dimensional contrast echocardiology. Although right-left shunts at atrial or ventricular level can easily be discovered and visualised after injection peripherally, the same is not true of left-right ventricular shunts; these are not detectable. As for left-right shunts (as demonstrated by oxymetry) at the atrial level, these are in a separate category; the passage of ultrasonic contrast medium from right to left is inconstant. This technique also allows the study of abnormal blood flow: tricuspid incompetence, turbulence caused by prosthetic valves, etc.

[Lani]

Am Heart J. 1993; 125(4):1136-41 (ISSN: 0002-8703)

Gin KG; Fenwick JC; Pollick C; Thompson CR
Department of Medicine, St. Paul's Hospital, Vancouver, B.C., Canada.

Three illustrative cases of refractory hypoxemia in adults are presented. In two cases contrast echocardiography was invaluable in establishing the diagnosis of a true anatomic right to left shunt, as well as in localizing the shunt to an intracardiac or extracardiac site. In the third case true anatomic right to left shunt was excluded by means of contrast echocardiography. The pathophysiology of hypoxemia is discussed with emphasis on the potential diagnostic utility of contrast echocardiology in patients with refractory hypoxemia. A diagnostic flow chart is proposed

[Lani]

: Am J Cardiol. 2007 Jun 15;99(12):1667-70. Epub 2007 May 2. Links
Usefulness of contrast echocardiography for assessment of left ventricular thrombus after acute myocardial infarction.

Mansencal N, Nasr IA, Pillière R, Farcot JC, Joseph T, Lacombe P, Dubourg O.
Cardiology Department, University Hospital Ambroise Paré, Assistance Publique-Hôpitaux de Paris, UFR de médecine Paris-Ile de France-Ouest, Faculté de Versailles-Saint Quentin en Yveline, Boulogne, France. nicolas.mansencal@apr.ap-hop-paris.fr
Fifty consecutive patients referred to a coronary care unit for acute anterior myocardial infarction with ST-segment elevation underwent coronary arteriography, left ventricular (LV) angiography, and revascularization. Transthoracic echocardiography was systematically performed using fundamental imaging, second harmonic imaging, and contrast agents to assess the LV chamber. Six patients (12%) presented with a confirmed LV mural thrombus. Thirty-five percent of patients with time to revascularization>3 hours presented with an LV mural thrombus versus 0 patients with time to revascularization<or=3 hours (p=0.003). The most accurate method of detecting LV mural thrombus was contrast echocardiography regardless of physician experience. No patient with a misdiagnosis of thrombus had an optimal acoustic window using fundamental imaging or second harmonic imaging. In conclusion, patients presenting with acute anterior myocardial infarction could benefit from contrast echocardiography for assessment of LV mural thrombus when acoustic windows are suboptimal and time to revascularization is >3 hours.
PMID: 17560872 [PubMed - indexed for MEDLINE]

[Lani]

... called islated left ventricular noncompaction...

Two-dimensional and color Doppler echocardiography has been
the diagnostic procedure of choice[for this rare form of cardiomyopathy]
, but the diagnosis is often missed
because of the limitations of near field imaging, especially in cases
with focal involvement such as the case presented here. Echo
contrast imaging improves the endocardial border definition and
could improve the detection of this rare type of cardiomyopathy,
which could otherwise be misdiagnosed.

[Lani]

detection of a saddle thrombus in the pulmonary artery in someone with chest pain...

J Am Soc Echocardiogr. 2007 Oct;20(10):1220.e1-3. Epub 2007 Jun 13. Links
Contrast echocardiography in acute chest pain.

McCabe C, Dwivedi G, Senior R.
Department of Cardiology, Northwick Park Hospital, Harrow, United Kingdom.
A 45-year-old man presented with atypical central chest pain and ST-T changes on electrocardiogram. Repeated arterial blood gas examinations were unremarkable and portable echocardiography demonstrated mildly dilated right atrium and ventricle. Initial treatment for acute coronary syndrome was initiated, as there was evidence of myocardial necrosis on blood examination. However, use of contrast agent enabled visualization of saddle embolus in the pulmonary artery on 2-dimensional echocardiography, which was later confirmed on computed tomographic pulmonary angiography. The patient subsequently made an uneventful recovery. Use of contrast agents in accident and emergency as a bedside tool can be very useful in patients with atypical presentation.
PMID: 17570636 [PubMed - in process]



Diagnostic and prognostic use of stress echo in acute coronary syndromes including emergency department imaging. [Echocardiography. 2000]
Usefulness of 64-slice cardiac computed tomographic angiography for diagnosing acute coronary syndromes and predicting clinical outcome in emergency department patients with chest pain of uncertain origin. [Circulation. 2007]
Italian Society of Cardiovascular Echography (SIEC) Consensus Conference on the state of the art of contrast echocardiography. [Ital Heart J. 2004]