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Contrast Media |
1 From the Department of Radiology, University of Michigan Health System, Room B1D502G, 1500 E Medical Center Dr, Ann Arbor, MI 48109-0030. Received March 28, 2006; revision requested May 26; revision received June 5; accepted June 21; final version accepted August 25. Address correspondence to R.H.C. (e-mail: rcohan{at}umich.edu).
| ABSTRACT |
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Materials and Methods: Institutional review board approval was obtained, and the requirement for informed consent was waived. The study was HIPAA compliant. For 69 657 intravenous injections of nonionic iodinated contrast medium for computed tomographic examinations between January 1, 2000, and March 31, 2005, the incident reports, radiology reports, and medical records of patients in whom contrast medium extravasations occurred were reviewed. Data collected included patient age, catheter gauge, injection site, volume extravasated, patient symptoms, severity of injury, treatment, whether or not the plastic surgery service was consulted and any additional treatment that service instituted, and patient outcome.
Results: Extravasations occurred in 475 (0.7%) of 69 657 patients, and follow-up information was available for 442 adults (280 women, 162 men; mean age, 57 years) and 17 children (nine girls, eight boys; mean age, 6 years). Extravasated volumes ranged from 3 to 150 mL. Symptoms usually consisted of swelling and/or pain. The plastic surgery service was consulted for 38 adults and six children and provided additional treatment in eight patients (seven adults, one child). Among adults, 432 had minimal or no adverse effects, nine had moderate adverse effects, and one had a severe complication (75 mL of contrast material extravasated into the hand, causing compartment syndrome). Only one moderate or severe complication in an adult resulted from an extravasation of less than 50 mL. Fifteen children had minimal or no adverse effects, one had moderate adverse effects, and one had a severe complication (18 mL of contrast material extravasated into the arm, causing brachial plexopathy).
Conclusion: Extravasation of nonionic iodinated contrast medium results only rarely in moderate or severe adverse effects, and these usually occur only when large volumes of contrast medium are involved.
© RSNA, 2007
Extravasation of iodinated radiographic contrast material is a well-known complication of iodinated radiographic contrast material injection, occurring even when appropriate intravenous injection techniques are used. In earlier series, the rate of extravasation during computed tomography (CT) was estimated to be 0.03%0.17% (13). Later reports with larger numbers of patients, published after automated mechanical injectors began to be routinely used for contrast material injection, demonstrated higher extravasation rates ranging from 0.25% to 0.9% (46).
The majority of extravasation injuries resolve without adverse effects (7); however, severe extravasation injuries have been reported after administration of both ionic (812) and nonionic contrast materials (1316), and some have resulted in tissue loss and neurovascular and musculoskeletal compromise (816). Multiple surgical procedures may be needed to treat these complications in some patients (8,9).
Few data exist on the frequency of contrast medium extravasations and the resulting complications. For example, to our knowledge the three largest published series (46) on this topic to date included only 140 extravasations altogether, 66 of which involved nonionic contrast material. No severe complications from the extravasations were observed in any of these series or reported in a more recent study of 11 extravasations (17). The purpose of our study was to determine retrospectively the frequency, management, and outcome of intravenous nonionic iodinated contrast medium extravasations.
| MATERIALS AND METHODS |
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The policy at our children's hospital is to choose 22-gauge catheters, although 20-gauge catheters are preferred in young adults and 24-gauge catheters are preferred in very young children. As in adults, in young patients, the catheters are preferentially placed in the antecubital fossa, with the hand the next most preferred site.
At both hospitals, injections were not made through peripherally inserted central catheter lines, since the newer ones that permit power injection (PowerPICC power injection catheter; Bard Access Systems, Salt Lake City, Utah) were not used during the study period. However, a nurse or physician can inject contrast medium by hand through a central line, arterial line, or port.
The technologists test each intravenous catheter through which contrast material is to be administered by briskly hand injecting saline through it. Once patency is established, the contrast medium injection can be started. Unless otherwise specified by the manufacturer, contrast material is warmed to body temperature before injection; this reduces viscosity. The technologist closely monitors the injection site from the commencement of injection to the beginning of scan acquisition. This allows the technologist to remain with the patient for 2570 seconds after initiation of contrast material injection. The patient is instructed to report any injection site discomfort. At completion of CT scanning, the injection site is inspected by the technologist for swelling or erythema.
In November 1994, our radiology department, in conjunction with the section of plastic surgery of the department of surgery, adopted a formal policy for documentation, management, and follow-up of patients with contrast material extravasation. Initial treatment of a patient in whom an extravasation is identified consists of application of ice packs or cold compresses to the extravasation site and elevation of the affected extremity above the level of the heart. A radiology resident or attending radiologist inspects each extravasation, and the patient is then monitored in the radiology department for up to 24 hours.
A consultation from the plastic surgery service is obtained if any of the following five criteria are met: (a) Extravasation volume is estimated to be 100 mL or more of nonionic contrast medium, (b) skin blistering occurs, (c) there is evidence of altered tissue perfusion, (d) pain at the extravasation site increases over time, and/or (e) there is a change in sensation at or adjacent to the extravasation site. The radiologist completes a departmental incident data form for contrast material extravasation, which includes patient identifying information, type and estimated volume of extravasated contrast material, site of extravasation, gauge of catheter used for the injection, patient signs and symptoms after extravasation, treatment instituted, and whether the plastic surgery service was consulted. These forms are filed in the radiology department for quality assurance monitoring and to facilitate follow-up.
Study Group
Institutional review board permission was obtained to access pertinent imaging and medical records of the patients involved in this study. The submitted institutional review board proposal was deemed to be compliant with both institutional requirements and the Health Insurance Portability and Accountability Act. Waiver of informed consent was granted.
Between January 1, 2000, and March 31, 2005, there were 69 657 intravenous injections of nonionic contrast medium for CT at our institution, 61 916 in adults and 7741 in children. During this period, nonionic iodinated contrast material was used for all contrast materialenhanced (iohexol 300 [Omnipaque 300; GE Healthcare, Waukesha, Wis]; iopromide 300 or 370 [Ultravist 300 or 370, respectively; Berlex Laboratories, Montville/Wayne, NJ]; or iodixanol 320 [Visipaque 320; GE Healthcare]) CT examinations. For this study, all of the contrast material extravasation incident data forms completed between January 1, 2000, and March 31, 2005, were reviewed by one of two authors (C.L.W. or R.H.C.). Data obtained from these forms included patient sex, patient age, type of contrast material extravasated, injection site, intravenous catheter gauge, contrast material injection rate, estimated extravasated volume (EEV), immediate symptoms (if any), initial treatment, and whether or not plastic surgery consultation was obtained. Medical records and radiology reports in the same patients were also reviewed by one of the same two authors (C.L.W. or R.H.C.) to determine the duration of symptoms, final outcome, and total duration of patient follow-up. Progress notes generated on the day of the extravasation and for at least 2 months after the extravasation were reviewed for mention of any adverse effects or treatment related to the extravasation. When adverse consequences were noted, additional progress notes were examined until patient symptoms had resolved or the instituted treatment was completed.
Each extravasation was classified by consensus between two authors (C.L.W. and R.H.C.) as producing mild, moderate, or severe injury. Mild extravasation injuries were those in which signs and symptoms were absent or consisted of only pain, swelling, and/or mild erythema, which resolved with limited treatment of elevation and administration of ice packs or cold compresses. No additional treatment was administered, and there was no mention of any adverse effects on the departmental extravasation form, in the dictated radiology report, or in any follow-up progress or clinic notes. Moderate extravasation injuries were those in which more severe initial manifestations were present, such as moderate or severe erythema, blistering, or marked pain or swelling, or injuries in which additional treatment was instituted, regardless of initial manifestations. However, to be considered moderate, all signs and symptoms had to have resolved within 2 weeks of the extravasation. Severe extravasation injuries either produced long-term adverse effects (lasting more than 2 weeks), such as unremitting pain, swelling, and limitations in extremity movement, or required surgical intervention. The medical records of patients who experienced moderate or severe extravasation were reviewed to assess for the presence of any risk factors (such as a history of diabetes mellitus or upper-extremity vascular or circulatory problems) that might explain why only these patients were affected adversely.
| RESULTS |
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The type of extravasated contrast material was recorded for 454 of the 459 extravasations. Iohexol 300 was extravasated in 387 patients (85%); iopromide 300, in 44 (10%); iodixanol, in 12 (3%); and iopromide 370, in 11 (2%). This distribution reflects the fact that iohexol was used almost exclusively between January 2000 and October 2004, with iopromide used between October 2004 and March 31, 2005. Iodixanol was administered to only a small group of patients with preexisting renal insufficiency. Precise data on the number of times each type of contrast material was injected were not available. No patient experienced more than one extravasation episode.
Extravasations in Adults
Injection site, injection rate, catheter gauge, and volume extravasated.The extravasation site was not mentioned for five patients. The most common extravasation site in the remaining 437 patients was the antecubital fossa (n = 196 [44.8%]). Other recorded extravasation sites were the forearm (n = 99 [22.6%]), hand (n = 47 [10.8%]), arm (n = 41 [9.4%]), wrist (n = 29 [6.6%]), upper arm (n = 16 [3.7%]), shoulder (n = 5 [1.1%]), foot (n = 2 [0.5%]), neck (n = 1 [0.2%]), and groin (n = 1 [0.2%]).
The injection rate was not recorded for 21 adults. Of the remaining 421 adult patients, 113 (27%) were injected at rates of less than 2 mL/sec; 212 (50%), at rates of 23 mL/sec; and 96 (23%), at rates exceeding 3 mL/sec.
The gauge of intravenous catheter used was not specified for 16 adult patients. For the remaining 426 adults, 22-gauge catheters were used in 125 (29%) and 20-gauge catheters were used in 284 (67%) patients. The remaining patients were injected through 18-gauge (n = 14), 16-gauge (n = 2), or 14-gauge (n = 1) catheters.
The volume of contrast medium extravasated was not recorded for six patients. The EEV was less than 10 mL in 45 (10%) of the remaining 436 patients, 1049 mL in 276 (63%), 5099 mL in 54 (12%), and 100150 mL in 61 (14%).
Symptoms and initial treatment (including plastic surgery consultation).The most commonly reported symptoms in the 442 adult patients were swelling (including descriptions of "bump," edema, or induration) in 350 patients (79%) and pain in 106 (24%). The absence of symptoms was reported for 36 (8%) patients. One of these patients was noted to be unresponsive (due to a preexisting medical condition). For four patients the incident report sheet did not mention whether or not symptoms were present.
Most patients (n = 241) were treated with cold compresses or ice packs, and elevation. Some patients received ice packs or cold compresses alone (n = 144) or elevation alone (n = 2). Although our policy was to use ice rather than warmth, three patients were treated with warm compresses and elevation, while three others had warm compresses applied without elevation. One patient received ice packs followed by warm compresses, and another patient received ice and topical hydrogen peroxide. In 38 patients the radiology resident or staff deemed that no treatment was necessary. In nine cases, no treatment was recorded.
Although our policy requires plastic surgery consultation for all patients whose extravasations involve 100 mL or more of contrast medium, the medical records documented such a consultation for only 32 (52%) of the 61 patients in this group. Plastic surgery consultations were also performed for six other patients owing to symptoms. The 38 evaluations led to additional treatment in seven patients. The additional treatment consisted of hand splints (n = 3), topical silver sulfadiazine (Silvadene; King Pharmaceuticals, Bristol, Tenn) application to blisters or open arm wounds (n = 2), use of a stockingette (a tubular bandage) (n = 1), or surgery (n = 1). In two patients, additional therapy was administered by another medical service already caring for the patient. One of the previously mentioned patients who had received a splint also received a subcutaneous injection of colchicine administered by the clinical inpatient service, as his extremity discomfort was believed to be due to aggravation of gout rather than extravasation. An additional patient (who was not evaluated by the plastic surgery service) received systemic antibiotics for presumed cellulitis.
Severity of extravasation injuries.Of the extravasation injuries, 432 were considered mild. Initial symptoms in these patients, if any were present, resolved without the need for any treatment other than ice or cold compresses and elevation, and there were no short- or long-term adverse consequences. There were nine moderate extravasation injuries involving a wide range of EEVs (10150 mL). Symptoms that resulted in the classification of these reactions as moderate included blistering (n = 3); persistent firmness, swelling, and/or pain (n = 3); ulceration (n = 1); discrete areas of persistent edema (n = 1); numbness (n = 1); suspected inflammation in the affected extremity, which was diagnosed 1 week after the extravasation (n = 1); "open arm" wounds (n = 1) (the term used in the patient's medical records); and ecchymosis (n = 1). In each of these patients, symptoms had resolved completely at 2-week follow-up (Table 1).
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Of the 10 patients with moderate or severe injuries, six (60%) were injected with iohexol 300; three (30%), with iopromide 300; and one (10%), with iodixanol. This distribution reflects the fact that iohexol was administered to many more patients than were the other agents during the study period.
The patients with moderate or severe extravasation injuries had a large number of medical conditions, but only a few of these conditions might have placed these patients at increased risk of an adverse effect after extravasation. Two of the 10 patients had connective tissue diseases (one had rheumatoid arthritis, and the other had systemic lupus erythematosus), one had type II diabetes mellitus, and one had had a single episode of lower-extremity deep vein thrombosis 1 year earlier. Other existing medical conditions in these patients included a history of cancer (n = 3), pancreatitis (n = 2), chronic lymphocytic leukemia, coronary artery disease, dehydration, dementia, emphysema, hypertension, hyperthyroidism, hypothyroidism, idiopathic thrombocytopenic purpura, inflammatory bowel disease, peptic ulcer disease, pneumonia, postoperative state, pseudomembranous colitis, and/or urinary tract infection (each n = 1).
Extravasations in Children
Injection site, injection rate, catheter gauge, and extravasated volume.A variety of extravasation sites were observed in children: the antecubital fossa (n = 4), arm (n = 4), hand (n = 3), and six other sites (shoulder, forearm, wrist, groin, ankle, and foot; each n = 1). One of these extravasations occurred from an indwelling catheter placed in the left upper arm, the tip of which was located near the shoulder. The remaining extravasations occurred from catheters placed specifically for the injection of contrast material. Eleven of the pediatric injections were performed at slow rates by hand. Automated injectors were used in five other patients, with a rate of 1.5 mL/sec used in three of these patients; 2 mL/sec, in one; and 2.5 mL/sec, in one. The injection method and rate were not recorded for the last patient. Catheters used for contrast material injection were 24 gauge (n = 4), 22 gauge (n = 6), 20 gauge (n = 2), and 16 gauge (n = 1). For four children, the catheter gauge was not recorded.
EEVs ranged from 4 to 125 mL. Volumes of 09 mL were seen in three children; volumes of 1049 mL, in 10; volumes of 5099 mL, in one; and volumes of 100150 mL, in three. The five largest extravasation volumes (125, 100, 100, 80, and 40 mL) were in children older than 12 years. The largest extravasation volume in a young child was 24 mL into the antecubital fossa of a 1-year-old patient, which resolved without adverse effects.
Symptoms and initial treatment (including plastic surgery consultation).The most commonly encountered clinical sign was swelling (13 children). Only four children reported having pain, in part because many children were too young to communicate with the health care providers. Initial treatment consisted of ice packs or cold compresses along with elevation in six patients, ice packs or cold compresses alone in six, and warm compresses in one. No treatment was mentioned for the remaining four patients. Plastic surgery consultation was documented in six instances. In two, the admitting service was notified of the extravasation and advised to consult the plastic surgery service; however, there were no notes indicating that these patients were subsequently examined by plastic surgery personnel. Additional treatment was instituted by the plastic surgery service in one child. The pediatric service instituted additional treatment in one other child.
Severity of extravasation injuries.Fifteen of the pediatric extravasation injuries were classified as mild; one was classified as moderate, and one was classified as severe. The moderate injury was encountered in a 16-year-old patient with traumatic brain injury in whom upper-extremity venous thrombosis developed 1 week after extravasation of 100 mL of iohexol through a 20-gauge catheter placed in the left arm. The patient was treated by the pediatric inpatient service with anticoagulants, and the thrombosis resolved without additional morbidity. While the clinical service believed that the thrombosis was very likely not due to the contrast material injection, since it developed 7 days after it, this patient was considered to have a moderate extravasation injury because a relationship between the extravasation and the thrombosis could not be excluded with certainty.
The single severe injury involved a 22-month-old girl who had a history of severe reflux and had recently undergone removal of an esophageal leiomyoma. After 18 mL of iohexol was injected through an indwelling catheter placed in her upper left arm, left upper-extremity movement ceased. On the CT scan, extensive extravasation was noted in the left axilla, extending over the apex of the left lung and dissecting into the left spinal canal via neural foramina at the C7, T1, and T2 vertebral levels (Fig 2). No intravascular contrast medium was seen. Magnetic resonance imaging revealed heterogeneous fluid in the left brachial plexus region.
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| DISCUSSION |
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As in previous series, in our study many of the extravasations involved large volumes of contrast material. Although the most frequently observed range of extravasated contrast material volumes was 1049 mL (in 276 of 436 adult patients and 10 of 17 children for whom volume estimates were available), extravasation volumes of 5099 mL (in 54 adults and one child) and 100150 mL (in 61 adults and three children) were encountered fairly often.
In our study, most patients were initially treated with only ice packs or cold compresses, along with elevation. Plastic surgery consultation was documented for only 44 patients (38 adults and six children), even though 64 patients (61 adults and three children) met the local criteria for such consultation because of the estimated volume of contrast material extravasated. However, only rarely did plastic surgery consultation result in additional therapy (in seven adults and one child), and even then the therapy was minimal in all but two patients. It consisted of splints, stockingette, or topical application of silver sulfadiazine in six adults, fasciotomy in one adult, and prolonged physical therapy in one child.
Our results confirm the rarity of moderate or severe extravasation injuries. The majority of extravasation injuries resolved shortly after they occurred, requiring only minimal conservative treatment. Of the 459 patients with extravasations and available follow-up data, only 12 had moderate or severe injuries and only one required surgery, to which the patient responded well. The next most severe injury, brachial plexopathy, was noted in a 22-month-old child and had completely resolved 1 year later.
Moderate or severe extravasation injuries were observed most commonly when larger volumes of contrast material were extravasated; however, our results did not justify our preexisting policy of requiring plastic surgery consultation when the EEV was 100 mL or more. The case of compartment syndrome developed after extravasation of 75 mL. Only five of the 10 moderate extravasation injuries involved EEVs of 100 mL or more, and, surprisingly, one moderate injury occurred after extravasation of only 10 mL of contrast medium. In fact, for adults and children combined, the extravasation volume range that was associated with the highest moderate or severe injury rate was 5099 mL (five of 55 patients [9.0%], compared with five of 64 patients [8.0%] in the 100150-mL group and two of 286 [0.7%] in the 1049-mL group). However, our results also suggest that the plastic surgery consultation resulted in very few important treatment changes. It therefore seems that only signs and symptoms should be used as criteria for plastic surgery consultation and additional treatment.
Our study had a number of important limitations. First, it was a retrospective review, and, as such, was entirely dependent on the quality, accuracy, and completeness of the extravasation data forms and the medical records. It is likely that the extravasation rate was underestimated, as some small-volume extravasations may not have been documented. Also, some information (eg, injection site, intravenous catheter gauge, and patient symptoms) was not provided for a few patients. Follow-up was not complete for all of the known extravasations, but our observation that moderate or severe adverse consequences were rare is probably still justified, because if additional treatment of an extravasation had been required, this occurrence probably would have been detected and documented.
Extravasation of contrast material often involves large volumes of contrast material and nearly always resolves with conservative treatment. Moderate injuries occur with a small number of extravasations, and severe injuries are even less frequent, even when large volumes of contrast medium are involved.
| ADVANCES IN KNOWLEDGE |
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| FOOTNOTES |
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Abbreviations: EEV = estimated extravasated volume
Authors stated no financial relationship to disclose.
Author contributions: Guarantors of integrity of entire study, C.L.W., R.H.C., N.R.D.; study concepts/study design or data acquisition or data analysis/interpretation, all authors; manuscript drafting or manuscript revision for important intellectual content, all authors; manuscript final version approval, all authors; literature research, C.L.W., R.H.C., N.R.D.; clinical studies, C.L.W., R.H.C., N.R.D.; and manuscript editing, all authors
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