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Unacceptable risk with GBCAs and other selected imaging approaches

There are a few pre-amble points that are important, and I will follow after my table, with notes on the table. I recognize that for each individual sufferer, in their mind the risk was 100% for the disease, because they got the disease. Unfortunately though with population studies, risk has to be calculated in an actuarial way for population groups. Having now essentially focused the last 2 years of my life and career to understand all aspects of GDD, I am now in a position to post my first, if you like, actuarial table on gadolinium toxicity (which includes acute hypersensitivity reaction [the important one being anaphylactoid shock], GDD, and NSF) but also selected medical radiation procedures and Iodine contrast. I will list the risky procedures reflecting a combination of likelihood and severity, in a descending order (worst on top).

1. Anaphylactoid shock and death. repeat of the same type of Iodine based contrast agent (IBCA, used in CT) or GBCA in a patient with well documented true anaphylactoid reaction and shock. Severity death, likelihood 1 in 10 of near-/death, 1 in 4 of severe.

Unacceptable risk in everyone - no contrast of the same type to be given.

2. GDD. repeat GBCA (all GBCAs) in a patient with pre-existent GDD. 100%, severity high - debilitating disease.

Unacceptable risk in everyone, no GBCA to be given.

3. NSF. Type-specific linear GBCA injection in a patient with stage 5 renal failure. Risk: NSF. Likelihood 4% for Omniscan, 2 % for Optimark, 0.1% for Magnevist, 0% for Multihance.

Unacceptable risk for Omniscan, Optimark, Magnevist.

4. Cancer. High dose radiation procedures: CT, angiography, PET/CT, PET, Nuclear Medicine. Level of risk determined by radiation exposure (measured as mSv). Highest risk, children, ultrahigh risk 1 year olds female > male. Risk of cancer 1 in 1000 with 10 mSV (in 40 yr old man), 1 in 100 in 1 yr old female.

Unacceptable risk in very young children, especially in the investigation of benign disease to have radiation exposure > 1 mSv.

5. GDD. Risk factors: white central European genetics, female, pre-existent autoimmune disease, recent high dose antibiotics, metabolic acidosis (includes intense exercise peri-MRI and dehydration).

Unacceptable risk for genetic central European females with a history of autoimmune disease (possibly also first relation family history) with recent high dose antibiotic treatment. Possible also if the same but male, and possibly also in females with the above minus high dose antibiotics. My risk estimate presently for GDD in white females with autoimmune disease is 0.5 %, With the addition of high dose antibiotics prior to the MRI, the risk increases to 1-5%.

6. Contrast Media induced Acute Kidney Injury (CI-AKI). Worst outcome is for individuals in stage 3 renal failure (eGFR 30-60) with IBCA. 0.1% of important persistent worsening.

There may be no unacceptable risk, depending on the indication, but in general IBCA should be avoided in stage 3 renal failure. The greatest concern is going from stage 3 renal failure, and decreasing renal function to stage 5 renal failure requiring dialysis, transplant. The risk for this may be 0.1%, and additional risk factors may be in effect.

A brief thumb-nail look at how I do these calculations on myself, taking into consideration the effectiveness of an imaging procedure, and using just one example.

So screening for liver or pancreatic cancer.

My considerations:

1. dynamic GBCA-enhanced MRI much better than the next best procedure dynamic IBCA-enhanced multiphase CT.

2. my personal risk for GDD extremely low (maybe 0.0001% - I have had 13 GBCA injections with no reaction).

3. my cancer risk as 59 yr old male for a multiphase CT (10 mSV) is 0.1%.

4. risk for contrast media acute kidney injury (CI-AKI) from IBCA is 0.01% from GBCA is 0.0001%.

5. anaphylactoid death risk from GBCA: 0.0001% and from IBCA: 0.0003%.

Factoring accuracy of study together with risk (my highest for all is cancer). I have said in the past, for many years, and is still true today, for imaging of liver and pancreas disease on myself I would get dynamic GBCA-enhanced MRI 1000 of 1000 times.

This calculation changes if I consider on myself what to do in the setting of major trauma, or serious interstitial lung disease.

1. in both these setting CT>>MRI, primarily in tis ability to image diseases of the lungs, so for example in major trauma: pneumothorax, tension pneumothorax, bronchus disruption, lung torsion (essentially all air-thin volume tissue interface considerations) CT is vastly superior to MRI.

The only noteworthy risk I have is for 3 above.

But the 1 in 1000 chance of cancer (and this may be 20 years down the road) is greatly outweighed by the risks of death from either major trauma, that the extent of injury is not accurately determined - the risk of death may be atleast 50% and immediate.

For interstitial lung disease ofcourse the risk of death is greatly lower than with major trauma, but accurate delineation and determination of type and extent of disease are important.

For major trauma on myself, 1000 of 1000 times I would get CT.

Important though to distinguish major trauma from minor trauma in this calculation.

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Richard Semelka, MD. Consulting

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