Comparison of indirect radiation dose estimates with directly measured radiation dose for patients and operators during complex endovascular procedures.

BACKGROUND: A great deal of attention has been directed at the necessity and potential for deleterious outcomes as a result of radiation exposure during diagnostic evaluations and interventional procedures. We embarked on this study in an attempt to accurately determine the amount of radiation exposure given to patients undergoing complex endovascular aortic repair. These measured doses were then correlated with radiation dose estimates provided by the imaging equipment manufacturers that are typically used for documentation and analysis of radiation-induced risk.
METHODS: Consecutive patients undergoing endovascular thoracoabdominal aneurysm (eTAAA) repair were prospectively studied with respect to radiation dose. Indirect parameters as cumulative air kerma (CAK), kerma area product (KAP), and fluoroscopy time (FT) were recorded concurrently with direct measurements of dose (peak skin dose [PSD]) and radiation exposure patterns using radiochromatic film placed in the back of the patient during the procedure. Simultaneously, operator exposure was determined using high-sensitivity electronic dosimeters. Correlation between the indirect and direct parameters was calculated. The observed radiation exposure pattern was reproduced in phantoms with over 200 dosimeters located in mock organs, and effective dose has been calculated in an in vitro study. Scatter plots were used to evaluate the relationship between continuous variables and Pearson coefficients.
RESULTS: eTAAA repair was performed in 54 patients over 5 months, of which 47 had the repair limited to the thoracoabdominal segment. Clinical follow-up was complete in 98% of the patients. No patients had evidence of radiation-induced skin injury. CAK exceeded 15 Gy in 3 patients (the Joint Commission on Accreditation of Healthcare Organizations [JCAHO] threshold for sentinel events); however, the direct measurements were well below 15 Gy in all patients. PSD was measured by quantifying the exposure of the radiochromatic film. PSD correlated weakly with FT but better with CAK and KAP (r = 0.55, 0.80, and 0.76, respectively). The following formula provides the best estimate of actual PSD = 0.677 + 0.257 CAK. The average effective dose was 119.68 mSv (for type II or III eTAAA) and 76.46 mSv (type IV eTAAA). The operator effective dose averaged 0.17 mSv/case and correlated best with the KAP (r = 0.82, P < .0001).
CONCLUSION: FT cannot be used to estimate PSD, and CAK and KAP represent poor surrogate markers for JCAHO-defined sentinel events. Even when directly measured PSDs were used, there was a poor correlation with clinical event (no skin injuries with an average PSD >2 Gy). The effective radiation dose of an eTAAA is equivalent to two preoperative computed tomography scans. The maximal operator exposure is 50 mSv/year, thus, a single operator could perform up to 294 eTAAA procedures annually before reaching the recommended maximum operator dose.