Risicofactoren voor hypersensitiviteitsreacties na CM
Uitgangsvraag
Welke patiënten hebben een verhoogd risico op hypersensitiviteitsreacties na contrastmiddeltoediening?
Aanbeveling
Beschouw alleen een eerdere hypersensitiviteitsreactie als een relevante risicofactor voor het ontwikkelen van een nieuwe hypersensitiviteitsreactie.
Overwegingen
Although various potential risk factors were identified in the five studies mentioned above, there are several limitations to be addressed.
First, all reported data solely address iodine-based contrast media (ICM). It is not clear whether these findings can be extrapolated to gadolinium-based contrast agents (GBCA).
Second, hypersensitivity reactions are generally diagnosed on clinical symptoms only and often in retrospect. Therefore, it is likely that the outcome group in many studies consists of a mixture of true HSR and other, nonimmune-mediated adverse events caused by severe physiological effects, chemotoxic effects and/or anxiety (Lalli, 1974). The increased odds ratio reported by Cha, 2019 for hyperthyroidism suggests inclusion of other reactions, since this risk factor was not reported by any other study and is suggestive of iodine-induced hyperthyroidism, which may present with clinical features with a certain overlap to mild hypersensitivity reactions.
Third, the hypersensitivity reactions are analysed together, while stratification for immediate vs nonimmediate reactions and based on severity would be preferred. Since immediate (IgE- or non-IgE-mediated mast cell activation) and nonimmediate (T-cell mediated) HSR are pathophysiological distinct, we assume that risk factors may be different as well. For example, a genetic predisposition is possible for T-cell mediated nonimmediate HSR since different HLA types may predispose for certain drug hypersensitivity reactions.
Since mast cells belong to the innate immune system, it is from a pathophysiological standpoint hard to understand why there would be an increased risk in certain families, except for rare forms of familial mastocytosis.
Moreover, except for Kim, 2017, none of the studies stratified outcomes according to severity of the HSR. This is important, since identifying risk factors for severe reactions such as anaphylaxis has the highest clinical relevance. Cha, 2019 and colleagues reported that 968 (68.8%) of the 1433 patients with an ICM-related HSR recovered spontaneously; identifying a risk factor for a self-limiting reaction has little clinical relevance and will not lead to adaption of protocols. Only the study by Kim (2017) reported outcomes separately for anaphylaxis. Since anaphylaxis is rare, it is difficult to gain sufficient power for statistical analyses.
Fourth, the robustness of findings depends on validation by other studies. A previous reaction to CM has been reported by several studies and is therefore more likely to be relevant than hyperthyroidism or a positive family history.
Fifth, the absolute OR or RR adds to the clinical relevance. Kim et al. (Kim, 2017) proposed
risk factor “body weight” (which is not clearly mentioned in the results, table 2 suggests that a higher body weight may be a risk factor but remains unclear) is a risk factor for (all) immediate HSR. With an OR of 1.02 this is of no clinical relevance, aside from the other limitations. Overall, the highest odds ratios were noted for previous CM reactions.
As mentioned before, it is uncertain whether previous reactions would be a risk factor for GBCA as well since literature on GBCA is scarce. A meta-analysis of nine studies in which immediate reactions to GBCA were recorded from a total of 716,978 GBCA administrations met the criteria for inclusion. The overall and severe rates of GBCA allergic-like adverse events were 9.2 and 0.52 per 10,000 administrations, respectively: 539 of 662 (81%) were mild, 86 (13%) were moderate, and 37 (6%) were severe reactions. The nonionic linear chelate gadodiamide had the lowest rate of reactions, at 1.5 per 10,000 administrations, which was significantly less than that of linear ionic GBCAs at 8.3 and nonionic macrocyclic GBCAs at 16 per 10,000 administrations. GBCAs known to be associated with protein-binding (like gadobenate) had a higher rate of reactions, at 17 per 10,000 administrations compared with the same chelate classification without protein binding, at 5.2 per 10,000 administrations (Behzadi, 2018).
A large retrospective study in children and adults studied all intravenous GBCA injections performed at a single institution. A total of 158,100 patients received 281,945 GBCA injections (140,645 gadodiamide, 94,109 gadobutrol, 39,138 gadobenate, and 8,053 gadoterate). At multivariate analysis, gadobenate or gadobutrol had higher rates of allergic- like reactions compared with gadodiamide (gadobenate: odds ratio (OR), 3.9; gadobutrol: OR, 2.3) or gadoterate (gadobenate: OR, 4.8; gadobutrol: OR, 2.8). Six severe allergic-like reactions (three gadobutrol, three gadobenate) occurred requiring hospitalization. Patient age (P = 0.025 to < 0.001), sex (P < 0.001), location (P = 0.006), and MRI type (P = 0.003 and P
= 0.006) were associated with acute reactions (McDonald, 2019).
Thus, both studies suggest that the type of GBCA may be a relevant risk factor, but do not take the severity of the reaction into account. The importance is limited as the total reaction rate is very low and the large majority of those reactions are mild and self-limiting.
Taken together, a previous reaction to CM appears to be the only clinically relevant risk factor for developing a new hypersensitivity reaction based on the currently available literature. It is plausible that the same holds true for GBCA, although there is currently not enough literature available to solidly confirm this.
In the ACR Manual on Contrast Media v.2021 (ACR, 2022) and the ESUR v10 guidelines (ESUR 2018), the most significant risk factor for increased risk of hypersensitivity reactions remains a documented history of a previous hypersensitivity reaction to a contrast medium. Patients with atopy/bronchial asthma or multiple allergies could not be established as a consistent risk factor (Chen, 2015; Jung, 2016).
Recommendations
|
Only consider a previous hypersensitivity reaction after contrast media administration a relevant risk factor for developing a new hypersensitivity reaction. |
Onderbouwing
Achtergrond
Like virtually any drug or substance, all types of contrast media have the potential to elicit a hypersensitivity reaction (HSR) (see also Introduction). Ideally, such adverse events are prevented, but this is difficult and to date not realistic. Identifying patients with an increased risk of developing HSRs would be a first step. General risk factors for an aggravated HSR include severe asthma, systemic mastocytosis, or the use of medication such as ß-blockers. In addition, patient in need of contrast media (CM) administration may report HSRs to a previous CM administration. This can involve objective signs or symptoms that fit well with a hypersensitivity reaction. However, in many cases other complaints are reported, such as hyperventilation, vasovagal reactions, or stress-induced responses such as throat tightness or panic attacks. These may not fit accurately with a hypersensitivity reaction to CM and thus may affect the risk of a HSR at repeated exposure.
All types of contrast media will be evaluated: iodine-based, gadolinium-based, and microbubble ultrasound CM. Also, all types of administration routes will be covered, intravascular (intravenous or intra-arterial), oral and rectal, intracavitary (joints or bladder), and intraductal (bile or pancreatic ducts). Nonvascular CM administration has already been summarized in Safe Use of Contrast Media, part 2.
Conclusies
|
Low GRADE |
The following factors were associated with an increased risk of adverse drug reaction in patients undergoing coronary angiography or percutaneous coronary intervention and receiving iopromide contrast:
Allergic constitution, asthma and sex were not independently associated with the risk of developing an adverse reaction.
Chen, 2015 |
|
Low GRADE |
The following factors were associated with an increased risk for developing a second acute allergic-like adverse reaction in patients with a history of a hypersensitivity reaction after low-osmolality contrast administration, who were undergoing another enhanced computed tomography with low- osmolality contrast medium and receiving premedication:
The following factors were not independently associated with the risk of acute allergic-like adverse reactions: sex, bronchial asthma, allergic rhinitis, chronic urticaria, food allergy, other drug allergy, H2-antihistamines premedication.
Jung, 2016 |
|
Low GRADE |
The following factors were associated with increased risk of immediate HSR:
The following factors were associated with increased risk of anaphylaxis:
The following factors were not independently associated with the risk of anaphylaxis: Iohexol, Iopamidol, sex, age, and body weight.
Kim, 2017 |
|
Low GRADE |
The following factors were associated with increased risk of occurrence and recurrence of ICM-related HSRs:
o HSR to ICM (OR: 56.3, 95% CI: 20 to 151)
o HSR to ICM (OR: 11.1, 95% CI: 1.4 to 85.9)
The following factor were associated with decreased risk of occurrence and recurrence of ICM related HSRs:
Cha, 2019 |
|
Low GRADE |
The following factors were associated with an increased risk for developing a second hypersensitivity reaction in patients with a history of a moderate or severe hypersensitivity reaction after low-osmolality contrast administration, who were undergoing another enhanced computed tomography with low- osmolality contrast medium and receiving premedication:
The following factors were not independently associated with the risk of developing a recurrent hypersensitivity reaction: sex, use of premedication.
Park, 2017 |
|
Low GRADE |
The following factors were associated with increased risk of immediate HSRs:
o Iomeprol (RR: 4.48, 95% CI: 3.09 to 6.48)
o 350 mg I/mL (RR: 4.66, 95% CI: 2.92 to 7.42) o ≥370 mg I/mL (RR: 2.83, 95% CI: 2.13 to 3.77)
The following factor were associated with decreased risk of acute HSRs:
Park, 2019 |
|
Low GRADE |
The following factors were associated with increased risk of immediate and nonimmediate HSR:
Sohn, 2019 |
|
Low GRADE |
The following factors were associated with increased risk of HSR:
The following factor was associated with increased risk of HSR:
|
Samenvatting literatuur
Description of studies
A total of 3 studies from Safe Use of Contrast Media, part 2 described factors independently related to the risk of hypersensitivity reactions after contrast administration. All studies presented multivariate models, but no internal or external validation of these models, or the results of application of these models in clinical practice.
A total of five studies described factors independently related to the risk of hypersensitivity reactions after contrast media administration. All studies presented multivariate models, but no internal or external validation of these models, or the results of application of these models in clinical practice.
Cha (2019) in a prospective cohort study described the risk factors associated with iodinated contrast media (ICM) -related hypersensitivity reactions in 196081 patients who underwent contrast-enhanced CT examinations from seven tertiary referral hospitals in Korea.
Chen (2015) described the risk factors associated with adverse reactions (occurring within 1 hour after contrast administration) in 17,513 patients who were administered iopromide (300 or 370 mgI/mL) contrast during coronary angiography or Percutaneous Coronary Intervention (PCI). All patients (not high-risk patients only) were included in this multicentre (63 centres in China) study.
Endrikat (2020) in a case control study described the risk factors associated with hypersensitivity reactions to iopromide after intra-arterial administration and intravenous
(IV) administration in 133,331 patients undergoing angiographic procedures (mostly cardio angiography) or contrast-enhanced CT. Four observational studies were pooled. Almost half of the study population (48.1%) was from Europe, and one quarter each from China (27.6%) and other Asia countries (24.1%). Hypersensitivity reactions were recorded for 822 patients, and 132,509 patients served as controls.
Kim (2017) in a retrospective cohort described the risk factors associated with immediate adverse drug reactions (ADRs) occurred within 1 h after administration of radiocontrast media (RCMs) in 1969 immediate ADRs from 286,087 examinations of 142,099 patients who underwent contrast-enhanced computed tomography (CT) examinations.
Jung (2016) described risk factors for developing a hypersensitivity reaction after re- administration of low-osmolality iodinated contrast medium for enhanced computed tomography in 322 patients with a history of hypersensitivity reactions after low-osmolality contrast administration. A total of 219 (68%) of the patients had a mild reaction, while 82 (26%) had a moderate reaction, and 21 (7%) a severe reaction in their history. Premedication was decided on an individual basis by clinicians and could consist of oral and/or intravenous H1-antihistamines, H2-antihistamins and corticosteroids.
Park (2017) described risk factors for developing a hypersensitivity reaction after administration of low-osmolar iodinated contrast medium for enhanced computed tomography in 150 patients with a history of moderate 130 (87%) to severe 20 (13%) hypersensitivity reactions after contrast administration in 328 instances of re-exposure. Patients received antihistamines and/or corticosteroids as pre-medication, the exact premedication was decided on an individual basis.
Park (2019) in a retrospective cohort described the risk factors associated with non-ionic ICM related hypersensitivity reactions in 21,947 adults during the control period and 26,491 patients during intervention period undergoing contrast–enhanced abdominal CT. Compared with CT during the control period, CT during the intervention period involved a reduced dose of contrast media achieved by lowering the CT tube voltage. Antihistamines alone were used for mild reactions, and steroids were used for moderate or severe reactions as pre-medication.
Sohn (2019) in a prospective cohort study described the risk factors associated with immediate and delayed coronary angiography (CAG)-induced ICM hypersensitivity in 714 patients who underwent CAG using intra-arterial (IA) administration of ICM including ioversol, a low-osmolar non-ionic monomer, and iodixanol, an iso-osmolar non-ionic dimer.
Results
Cha (2019) reported that the overall prevalence of HSRs was 0.73% (1,433 of 196,081), while severe reactions occurred in 0.01% (17 of 196,081). In terms of severity, 83.2% of the events were classified as mild HSRs, with a relative prevalence of 83.2% (overall 0.61%; 1,192 of 196,081); 15.6% as moderate HSRs (overall 0.11%; 224 of 196,081); and 1.2% as severe HSRs (overall 0.01%; 17 of 196,081).
The following factors were associated with increased risk of occurrence and recurrence of ICM related HSRs:
- Hyperthyroidism (OR: 4.00, 95% CI: 1.4 to 12.1)
- Drug allergy (OR: 5.2, 95% CI: 2.8 to 9.7)
- Asthma (OR: 2.3, 95% CI: 1.1 to 4.9)
- Other allergic disease (OR: 9.5, 95% CI: 4.1 to 22.1)
- Past history of ICM exposure
- HSR to ICM (OR: 56.3, 95% CI: 20 to 151)
- Family history
- HSR to ICM (OR: 11.1, 95% CI: 1.4 to 85.9)
The following factor was associated with decreased risk of occurrence and recurrence of ICM related HSRs:
- Past history of ICM exposure
- No HSR to ICM usage (OR: 0.7, 95% CI: 0.6 to 0.8)
Chen (2015) reported that acute adverse drug reactions (ADRs) occurred in 66/17,513 (0.38%) patients undergoing iopromide (300 or 370 mgI/mL) administration during coronary angiography or Percutaneous Coronary Intervention (PCI), out of which 2 ADRs (0.01%) were severe. Most ADRs manifested as nausea vomiting (0.22%) and rash (0.09%).
The following factors were associated with risk of ADR:
- Age 50 to 69 versus age < 50 (OR: 0.48, 95% CI: 0.27 to 0.85)
- Premedication with corticosteroids (OR: 0.41, 95% CI: 0.18 to 0.97)
- Contrast dose ≥ 100mL (OR 0.50, 95% CI 0.30 to 0.82)
- Pre-procedural hydration (OR: 0.11, 95% CI: 0.04 to 0.33)
- Left main coronary disease (OR: 2.27, 95% CI: 1.15 to 4.48)
- Previous ADR to contrast (OR: 9.30, 95% CI: 1.10 to78.84)
Allergic constitution, asthma and sex were not independently associated with the risk of developing an adverse reaction.
Endrikat (2020) reported HSR in 822/133,331 patients (0.62%). The most frequent hypersensitivity reactions were skin reactions (erythema, urticaria, rash), reported in 508 patients (0.38%), followed by pruritus (n = 294; 0.22%), cough/ sneezing (n = 151; 0.11%), and dyspnoea/bronchospasm (n = 105; 0.08%). Hypersensitivity reactions were significantly more frequently recorded after IV than after IA administration, 0.7% versus 0.2%, respectively. Their follow-up study (Endrikat, 2022) reported a decreased risk of HSR in elderly > 65 years, at least when iopromide was used.
The following factors were associated with increased risk of HSR:
- Age
- 50-<65 (OR: 1.67, 95% CI: 1.38 to 2.02)
- 18-<50 (OR: 2.16, 95% CI: 1.78 to 2.62)
- Female (OR: 1.16, 95% CI: 1.01 to 1.34)
- Diabetes mellitus (OR: 1.54, 95% CI: 1.19 to 2.00)
- Allergy (OR: 3.61, 95% CI: 2.84 to 4.59)
- Asthma (OR: 2.14, 95% CI: 1.26 to 3.62)
- Previous contrast media reaction (OR: 4.31, 95% CI: 2.75 to 6.75)
- Other concomitant disease: (OR: 1.42, 95% CI: 1.19 to 1.70)
- Geographic region: Asia (OR: 1.80, 95% CI: 1.54 to 2.11)
- Dose of iodine in CM
- >20–40 g (OR: 1.24, 95% CI: 1.01 to 1.51)
- Iopromide concentration
- Iopromide 370 (OR: 1.31, 95% CI: 1.12 to 1.54)
The following factor were associated with decreased risk of HSR:
- IA Injection route (OR: 0.23, 95% CI: 0.16 to 0.32)
- >65 (OR: 0.51 95% CI: 0.43 to 0.61)
Jung (2016) described that 47/322 (15%) of the patients experienced a recurrence of an allergic reaction after low-osmolality iodinated contrast medium administration for computed tomography, despite premedication.
The following factors were associated with an increased risk for developing this second acute allergic-like adverse reaction:
- Age (OR: 0.97, 95% CI: 0.94 to 0.99).
- Previous severe reaction (OR: 8.88, 95% CI: 2.11 to 37.42).
- Not using corticosteroid premedication (OR: 0.28, 95% CI: 0.10 to 0.78) - people that used corticosteroid medications had a lower risk to experience an allergic reaction.
The following factors were not independently associated with the risk of acute allergic-like adverse reactions: sex, bronchial asthma, allergic rhinitis, chronic urticaria, food allergy, other drug allergy, H2-antihistamines premedication.
Kim (2017) reported that immediate adverse drug reactions (ADRs) occurred in 1969 cases of ADR (0.69%) among 286,087 cases in 142,099 patients who underwent contrasted CT examinations. Rash (85.3%) and itching sensation (59.8%) were the most frequent symptoms. Among these immediate ADRs, 68 cases were classified as anaphylaxis (0.024%). They found that iopromide had the highest incidence of immediate ADRs (1.03%) and was followed by iopamidol (0.67%), iohexol (0.64%), and iobitridol (0.34%). In cases of anaphylaxis, iopromide also showed the highest incidence (0.041%), followed by iopamidol (0.023%), iohexol (0.018%), and iobitridol (0.012%).
The following factors were associated with increased risk of immediate ADR:
- Types of RCMs (compared to iobitridol)
- Iohexol (OR: 1.36, 95% CI:1.08 to 1.72)
- Iopamidol (OR: 1.59, 95% CI: 1.28 to 1.98)
- Iopromide (OR: 2.72, 95% CI: 2.17 to 3.41)
- Multiple CT examinations (OR: 2.13, 95% CI: 1.89 to 2.38)
- Female sex (OR: 1.51, 95% CI: 1.36 to 1.67)
- Age 20 to 50 (OR: 1.55, 95% CI: 1.01 to 2.37)
- Body weight (OR: 1.02, 95% CI: 1.01 to 1.02)
The following factors were associated with increased risk of anaphylaxis:
- Iopromide (OR: 6.24, 95% CI: 1.32 to 29.44)
- Multiple CT examinations (OR: 3.26, 95% CI: 1.81 to 5.86)
The following factors were not independently associated with the risk of anaphylaxis: iohexol, iopamidol, sex, age, and body weight.
Park (2017) reported that a recurrence of hypersensitivity reactions after contrast exposure occurred in 64/328 (20%) of the instances of re-exposure to low-osmolar iodinated contrast in patients with a history of moderate or severe reactions.
The following factors were associated with an increased risk for developing this second hypersensitivity reaction:
- Age (OR: 0.97, 95% CI 0.94 to 0.99);
- Diabetes mellitus (OR: 6.49, 95% CI: 2.38 to 17.71);
- Chronic urticaria (OR: 7.61, 95% CI: 1.63 to 35.59);
- Drug allergy (OR: 3.69, 95% CI: 1.18 to 11.56);
- Changing the iodinated contrast medium (OR: 0.33, 95% CI: 0.17 to 0.64);
- Initial hypersensitivity reaction was severe (OR: 2.67, 95% CI: 1.05 to 6.79).
The following factors were not independently associated with the risk of developing a recurrent hypersensitivity reaction: sex, use of premedication.
Park (2019) reported the following factors associated with increased risk of acute HSRs:
- Female (RR: 1.22 (95% CI: 1.04 to 1.43)
- History of acute hypersensitivity to iodinated contrast material (RR: 10.4, 95% CI: 4.51 to 24.2)
- Contrast media used for study CT
- Iomeprol (RR: 4.48, 95% CI: 3.09 to 6.48)
- Iodine concentration for study CT
- 350 mg I/mL (RR: 4.66, 95% CI: 2.92 to 7.42)
- ≥370 mg I/mL (RR: 2.83, 95% CI: 2.13 to 3.77)
The following factors were associated with decreased risk of acute HSRs:
- Age (RR: 0.98, 95% CI: 0.97 to 0.98)
- Premedication for study CT
- Antihistamines alone (RR: 0.39, 95% CI: 0.17 to 0.9)
- Steroid with or without antihistamines (RR: 0.37, 95% CI: 0.16 to 0.89)
- Type of CT examination
- Multiphase (RR: 0.41, 95% CI: 0.32 to 0.52)
Sohn (2019) reported 26 of 714 (3.6%) patients with immediate HSR and 108 of 714 (15.1%) with non-immediate HSR after IA contrast administration. With regard to severity, the proportion of immediate HSR grades 1, 2, and 3 was 57.7%, 38.5%, and 3.8%, respectively,
whereas that of non-immediate HSR grades 1, 2, and 3 was 85.2%, 13.9%, and 0.9%, respectively.
The following factors were associated with increased risk of immediate and nonimmediate HSR:
- Immediate HSR: Previous IA exposure (OR: 2.92, 95% CI: 1.22 to 6.96)
- Nonimmediate HSR: Iodixanol (OR: 1.61, 95% CI: 1.07 to 2.43)
Level of evidence of the literature
For all included patient populations, the quality of certainty of evidence for the outcome hypersensitivity reaction was downgraded from high to low by two points, due to risk of bias and indirectness: the prognostic factors were identified, but the prognostics model was not validated internally and externally. The value of the applicability of the multivariate models in a clinical decision-making process was not evaluated. The study sample in the primary studies do not accurately reflect the review question.
Zoeken en selecteren
A systematic review of the literature was performed to answer the following question: Which factors are related to an increased risk of developing hypersensitivity reactions after contrast administration?
P: (Patients) Patients undergoing radiological examinations with contrast media
I: (Intervention) Presence of prognostic factors
C: (Control) Absence of prognostic factors
O: (Outcome) Allergic reactions to contrast media, hypersensitivity reaction, type I / type IV, severe allergic reaction
Relevant outcome measures
The working group considered allergic / hypersensitivity reactions to contrast media critical outcome measures for the decision-making process.
Search and select (Methods)
The databases Medline (via OVID) and Embase (via Embase.com) were searched with relevant search terms until April 22nd, 2021. The detailed search strategy is depicted under the tab Methods. The systematic literature search resulted in 400 hits.
Studies were selected based on the following criteria:
- Adult patients undergoing radiological examinations with contrast media.
- Evaluation or identification of factors associated with an increased risk of hypersensitivity reactions after contrast administration. These factors could be treatment related, or patient related. Studies were only included when the identified risk factors were corrected for confounders (multivariate models).
- Reports predefined outcome measure: hypersensitivity reactions.
- No reports of case series or exploratory findings (n ≥ 10).
Based on title and abstract a total of forty-seven studies were selected. After examination of full text, a total of forty-two studies were excluded and five studies were included in the literature summary. Reason for exclusion is reported in the exclusion table.
Five studies were included for the research question regarding the identification of factors associated with an increased risk of hypersensitivity reactions after contrast administration. The most important study characteristics and results were included in the evidence tables. The evidence tables and assessment of individual study quality are included.
Referenties
- American College of Radiology. ACR Manual on contrast media, v2022. Available at: [URL].
Accessed: 15. April 2022. - Behzadi AH, Zhao Y, Farooq Z, Prince MR. Immediate allergic reactions to gadolinium-based contrast agents: systematic review and meta-analysis. Radiology 2018; 286: 471-482.
- Cha MJ, Kang DY, Lee W, Yoon SH, Choi YH, Byun JS, Lee J, Kim YH, Choo KS, Cho BS, Jeon KN, Jung JW, Kang HR. Hypersensitivity Reactions to iodinated contrast media: a multicenter study of 196,081 patients. Radiology. 2019; 293:117-124.
- Chen JY, Liu Y, Zhou YL, et al. Safety and tolerability of iopromide in patients undergoing cardiac catherization: real-world multicenter experience with 17,513 patients from the TRUST trial. Int J Cardiovasc Imaging 2015; 31: 1281-1291.
- Endrikat J, Michel A, Kölbach R, Lengsfeld P, Vogtländer K. Risk of hypersensitivity reactions to iopromide after intra-arterial versus intravenous administration: a nested case- control analysis of 133,331 patients. Invest Radiol. 2020; 55:38-44.
- European Society of Urogenital Radiology Contrast Media Safety Committee. ESUR Guidelines on contrast safety, v10. Available at: [URL]. Accessed: 15. April 2022.
- Jung JW, Choi YH, Park CM, Park HW, Cho SH, Kang HR. Outcomes of corticosteroid prophylaxis for hypersensitivity reactions to low osmolar contrast media in high-risk patients. Ann Allergy Asthma Immunol 2016; 117: 304-309.
- Kim SR, Lee JH, Park KH, Park HJ, Park JW. Varied incidence of immediate adverse reactions to low-osmolar non-ionic iodide radiocontrast media used in computed tomography. Clin Exp Allergy. 2017; 47:106-112.
- McDonald JS, Hunt CH, Kolbe AB, Schmitz JJ, Hartman RP, et al. Acute adverse events following Gadolinium-Based Contrast Agent administration: a single-center retrospective study of 281,945 injections. Radiology 2019; 292: 620-627.
- Park HJ, Park JW, Yang MS, Kim MY, Kim SH, Jang GC, et al. Re-exposure to low osmolar iodinated contrast media in patients with prior moderate-to-severe hypersensitivity reactions: A multicentre retrospective cohort study. Eur Radiol 2017; 27: 2886-2893.
- Park HJ, Son JH, Kim TB, Kang MK, Han K, Kim EH, Kim AY, Park SH. Relationship between lower dose and injection speed of iodinated contrast material for CT and acute hypersensitivity reactions: An observational study. Radiology. 2019; 293:565-572.
- Pichler WJ. The important role of non-covalent drug-protein interactions in drug hypersensitivity reactions. Allergy. 2022; 77(2): 404-415.
- Sohn KH, Kim GW, Lee SY, Kim HS, Cho SH, Han JK, Kang HR. Immediate and delayed hypersensitivity after intra-arterial injection of iodinated contrast media: a prospective study in patients with coronary angiography. Eur Radiol. 2019; 29: 5314- 5321.
Verantwoording
Autorisatiedatum en geldigheid
Laatst beoordeeld : 28-11-2022
Laatst geautoriseerd : 28-11-2022
Geplande herbeoordeling :
Validity
The Radiological Society of the Netherlands (NVvR) will determine around 2027 if this guideline (per module) is still valid and applicable. If necessary, the scientific societies will form a new guideline group to revise the guideline. The validity of a guideline can be shorter than 5 years, if new scientific or healthcare structure developments arise, that could be a reason to commence revisions. The Radiological Society of the Netherlands is the owner of this guideline and thus primarily responsible for the actuality of the guideline. Other scientific societies that have participated in the guideline development share the responsibility to inform the primarily responsible scientific society about relevant developments in their field.
Algemene gegevens
General Information
The Kennisinstituut van de Federatie Medisch Specialisten (www.kennisinstituut.nl) assisted the guideline development group. The guideline was financed by Stichting Kwaliteitsgelden Medisch Specialisten (SKMS) which is a quality fund for medical specialists in The Netherlands.
Samenstelling werkgroep
Guideline development group (GDG)
A multidisciplinary guideline development group (GDG) was formed for the development of the guideline in 2020. The GDG consisted of representatives from all relevant medical specialization fields which were using intravascular contrast administration in their field.
All GDG members have been officially delegated for participation in the GDG by their scientific societies. The GDG has developed a guideline in the period from June 2020 until November 2022. The GDG is responsible for the complete text of this guideline.
Guideline development group
- Dekkers I.A. (Ilona), clinical epidemiologist and radiologist, Leiden University Medical Center, Leiden
- Geenen R.W.F. (Remy), radiologist, Noordwest Ziekenhuisgroep, Alkmaar
- Kerstens M.N. (Michiel), internist-endocrinologist, University Medical Centre Groningen
- Krabbe J.G. (Hans), clinical chemist-endocrinologist, Medisch Spectrum Twente, Enschede
- Rossius M.J.P. (Mariska), radiologist, Erasmus Medical Centre, Rotterdam
- Uyttenboogaart M. (Maarten), neurologist and neuro-interventionalist, University Medical Centre Groningen
- van de Luijtgaarden K.M. (Koen), vascular surgeon, Maasstad Ziekenhuis, Rotterdam
- van der Molen A.J. (Aart), chair guideline development group, radiologist, Leiden University Medical Center, Leiden
- van der Wolk S.L. (Sabine), gynaecologist-obstetrician, Haga Ziekenhuis, Den Haag
- van de Ven A.A.J.M. (Annick), internist-allergologist-immunologist, University Medical Centre Groningen (until 1.7.2022)
- van der Houwen, T.B. (Tim), internist-allergologist-immunologist, Amsterdam University Medical Center (from 1.7.2022)
Invited experts
- van Maaren M.S. (Maurits), internist-allergologist-immunologist, Erasmus MC, Rotterdam
Methodological support
- Abdollahi M. (Mohammadreza), advisor, Knowledge Institute of the Federation Medical Specialists
- Labeur Y.J. (Yvonne), junior advisor, Knowledge Institute of the Federation Medical Specialists
- Mostovaya I.M. (Irina), senior advisor, Knowledge Institute of the Federation Medical Specialists
Belangenverklaringen
Conflicts of interest
The GDG members have provided written statements about (financially supported) relations with commercial companies, organisations or institutions that were related to the subject matter of the guideline. Furthermore, inquiries have been made regarding personal financial interests, interests due to personal relationships, interests related to reputation management, interest related to externally financed research and interests related to knowledge valorisation. The statements on conflict of interest can be requested from the administrative office of Kennisinstituut van de Federatie Medisch Specialisten (secretariaat@kennisinstituut.nl) and were summarised below.
|
Last name |
Function |
Other positions |
Personal financial interests |
Personal relations |
Reputation management |
Externally financed research |
Knowledge valorisation |
Other interests |
Signed |
Actions |
|
Dekkers IA |
Radiologist, LUMC |
Clinical Epidemiologist
Member of contrast media safety committee, European Society of Urogenital Radiology (no payment)
Member, Gadolinium Research and Education Committee, European Society of Magnetic Resonance in Medicine, and Biology (no payment) |
No |
No |
No |
No |
No |
Received consultancy fees from Guerbet, 2019- 2022 |
July 24th, 2020, Reaffirmed October 12th, 2022 |
No restrictions: received in part 3 of the guideline speaker fees, but this guideline does not mention specific medication, not of working mechanism, nor of side effects. |
|
Geenen RWF |
Radiologist, Noordwest ziekenhuisgroep /Medisch specialisten Noordwest |
Member of contrast media safety committee, European Society of Urogenital Radiology (no payment) |
No |
No |
No |
No |
No |
No |
April 11th, 2020, Reaffirmed October 12th, 2022 |
No restrictions |
|
Houwen T, van der |
Internist - Immunologist - Allergologist, Amsterdam UMC, also seconded allergologist in Huid Medisch Centrum |
None |
None |
None |
None |
None |
None |
None |
July 11th, 2022 Reaffirmed October 12th, 2022 |
No restrictions |
|
Kerstens MN |
Internist- endocrinologist, UMCG |
Chairman Bijniernet (no payment) |
No |
No |
No |
No |
No |
No |
July 1st, 2020, reaffirmed October 25th, 2022 |
No restrictions |
|
Krabbe JG |
Clinical chemist, Medisch Spectrum Twente |
No |
No |
No |
No |
No |
No |
No |
September 1st, 2020, Reaffirmed October 13th, 2022 |
No restrictions |
|
Luijtgaarden KM, van de |
Vascular surgeon, Maasland Ziekenhuis |
No |
No |
No |
No |
No |
No |
No |
August 1st, 2020, reaffirmed October 26th, 2022 |
No restrictions |
|
Molen AJ, van der |
Radiologist LUMC |
Member of contrast media safety committee, European Society of Urogenital Radiology (no payment)
Member, Gadolinium Research and Education Committee, European Society of Magnetic Resonance in Medicine, and Biology (no payment) |
No |
No |
No |
No |
No |
Received consultancy fees from Guerbet, 2019- 2022 |
July, 24th, 2020 Reaffirmed October 12th, 2022 |
No restrictions: received in part 3 of the guideline speaker fees, but this guideline does not mention Specific medication, not of working mechanism, nor of side effects. |
|
Rossius MJP |
Radiologist Erasmus Medical Centre |
Medical coordinator (no payment) |
No |
No |
No |
No |
No |
No |
April 7th, 2020, Reaffirmed October 13th, 2022 |
No restrictions |
|
Uyttenboogaart M |
Neurologist and neuro- interventionalist UMCG |
Advisor International Federation of Orthopaedic Manipulative Physical Therapist / Nederlandse Vereniging Manuele Therapie |
No |
No |
Subsidy Hart Stichting for CONTRAST (Consortium of New Treatments in Acute Stroke): WP8 Stroke logistics and Epidemiology: financing of 2 PhD students by the Hart Stichting / PPS Allowance |
Work package leader CONTRAST (Consortium of New Treatments in Acute Stroke): WP8 Stroke logistics and Epidemiology |
No |
No |
June 30th, 2020, reaffirmed October 26th, 2022 |
No restrictions: the CONTRAST consortium wp8 is only about organisation and treatment of stroke. Stroke is not in this guideline. |
|
Ven AAJM, van de |
Internist- allergologist- immunologist, UMCG |
Education and research related to work as internist- allergist |
No |
No |
No |
No |
No |
No |
April 7th, 2020, Reaffirmed October 19th, 2022 |
No restrictions |
|
Wolk S, van der |
Gynaecologist- obstetrician, Haga Ziekenhuis |
No |
No |
No |
No |
No |
No |
No |
June 30th, 2021, reaffirmed October 25th, 2022 |
No restrictions |
Inbreng patiëntenperspectief
Input of patient’s perspective
The guideline does not address a specific adult patient group, but a diverse set of diagnoses. Therefore, it was decided to invite a broad spectrum of patient organisations for the stakeholder consultation. The stakeholder consultation was performed at the beginning of the process for feedbacking on the framework of subjects and clinical questions addressed in the guideline, and during the commentary phase to provide feedback on the concept guideline. The list of organisations which were invited for the stakeholder consultation can be requested from the Kennisinstituut van de Federatie Medisch Specialisten (secretariaat@kennisinstituut.nl). In addition, patient information on safe use of contrast media in pregnancy and lactation was developed for Thuisarts.nl, a platform to inform patients about health and disease.
Implementatie
During different phases of guideline development, implementation and practical enforceability of the guideline were considered. The factors that could facilitate or hinder the introduction of the guideline in clinical practice have been explicitly considered. The implementation plan can be found in the ‘Appendices to modules’. Furthermore, quality indicators were developed to enhance the implementation of the guideline. The indicators can also be found in the ‘Appendices to modules’.
Werkwijze
Methodology
AGREE
This guideline has been developed conforming to the requirements of the report of Guidelines for Medical Specialists 2.0 by the advisory committee of the Quality Counsel (www.kwaliteitskoepel.nl). This report is based on the AGREE II instrument (Appraisal of Guidelines for Research & Evaluation II) (www.agreetrust.org), a broadly accepted instrument in the international community and based on the national quality standards for guidelines: “Guidelines for guidelines” (www.zorginstituutnederland.nl).
Identification of subject matter
During the initial phase of the guideline development, the GDG identified the relevant subject matter for the guideline. The framework is consisted of both new matters, which were not yet addressed in part 1 and 2 of the guideline, and an update of matters that were subject to modification (for example in case of new published literature). Furthermore, a stakeholder consultation was performed, where input on the framework was requested.
Clinical questions and outcomes
The outcome of the stakeholder consultation was discussed with the GDG, after which definitive clinical questions were formulated. Subsequently, the GDG formulated relevant outcome measures (both beneficial and harmful effects). The GDG rated the outcome measures as critical, important and of limited importance (GRADE method). Furthermore, where applicable, the GDG defined relevant clinical differences.
Search and select
For clinical questions, specific search strategies were formulated, and scientific articles published in several electronic databases were searched. First, the studies that potentially had the highest quality of research were reviewed. The GDG selected literature in pairs (independently of each other) based on the title and abstract. A second selection was performed by the methodological advisor based on full text. The databases used, selection criteria and number of included articles can be found in the modules, the search strategy in the appendix.
Quality assessment of individual studies
Individual studies were systematically assessed, based on methodological quality criteria that were determined prior to the search. For systematic reviews, a combination of the AMSTAR checklist and PRISMA checklist was used. For RCTs the Cochrane risk of bias tool and suggestions by the CLARITY Group at McMaster University were used, and for cohort studies/observational studies the risk of bias tool by the CLARITY Group at McMaster University was used. The risk of bias tables can be found in the separate document Appendices to modules.
Summary of literature
The relevant research findings of all selected articles were shown in evidence tables. The evidence tables can be found in the separate document Appendices to modules. The most important findings in literature were described in literature summaries. When there were enough similarities between studies, the study data were pooled.
Grading quality of evidence and strength of recommendations
The strength of the conclusions of the included studies was determined using the GRADE- method. GRADE stands for Grading Recommendations Assessment, Development and Evaluation (see http://www.gradeworkinggroup.org) (Atkins, 2004). GRADE defines four levels for the quality of scientific evidence: high, moderate, low, or very low. These levels provide information about the certainty level of the literature conclusions (http://www.guidelinedevelopment.org/handbook).
The evidence was summarized in the literature analysis, followed by one or more conclusions, drawn from the body of evidence. The level of evidence for the conclusions can be found above the conclusions. Aspects such as expertise of GDG members, local expertise, patient preferences, costs, availability of facilities and organisation of healthcare aspects are important to consider when formulating a recommendation. These aspects are discussed in the paragraph justifications. The recommendations provide an answer to the clinical question or help to increase awareness and were based on the available scientific evidence and the most relevant justifications.
Appendices
Internal (meant for use by scientific society or its members) quality indicators were developed with the guideline and can be found in the separate document Appendices to modules. In most cases, indicators were not applicable. For most questions, additional scientific research on the subject is warranted. Therefore, the GDG formulated knowledge gaps to aid in future research, which can be found in the separate document Appendices to modules.
Commentary and authorisation phase
The concept guideline was subjected to commentaries by the involved scientific societies. The list of parties that participated in the commentary phase can be requested from the Kennisinstituut van de Federatie Medisch Specialisten (secretariaat@kennisinstituut.nl). The commentaries were collected and discussed with the GDG. The feedback was used to improve the guideline; afterwards the GDG made the guideline definitive. The final version of the guideline was offered to the involved scientific societies for authorization and was authorized.
Literature
Brouwers MC, Kho ME, Browman GP, et al. AGREE Next Steps Consortium. AGREE II: advancing guideline development, reporting and evaluation in health care. CMAJ. 2010; 182(18): E839-E842.
Medisch Specialistische Richtlijnen 2.0. Adviescommissie Richtlijnen van de Raad Kwaliteit, 2012. Available at: [URL].
Schünemann H, Brożek J, Guyatt G, et al. GRADE handbook for grading quality of evidence and strength of recommendations. Updated October 2013. The GRADE Working Group, 2013. Available at: [URL].
Schünemann HJ, Oxman AD, Brozek J, et al. Grading quality of evidence and strength of recommendations for diagnostic tests and strategies. BMJ. 2008;336(7653):1106- 1110. Erratum published in: BMJ 2008;336(7654).
Ontwikkeling van Medisch Specialistische Richtlijnen: stappenplan. Kennisinstituut van Medisch Specialisten, 2020.