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1.  Advanced Electrophysiologic Mapping Systems 
Executive Summary
To assess the effectiveness, cost-effectiveness, and demand in Ontario for catheter ablation of complex arrhythmias guided by advanced nonfluoroscopy mapping systems. Particular attention was paid to ablation for atrial fibrillation (AF).
Clinical Need
Tachycardia refers to a diverse group of arrhythmias characterized by heart rates that are greater than 100 beats per minute. It results from abnormal firing of electrical impulses from heart tissues or abnormal electrical pathways in the heart because of scars. Tachycardia may be asymptomatic, or it may adversely affect quality of life owing to symptoms such as palpitations, headaches, shortness of breath, weakness, dizziness, and syncope. Atrial fibrillation, the most common sustained arrhythmia, affects about 99,000 people in Ontario. It is associated with higher morbidity and mortality because of increased risk of stroke, embolism, and congestive heart failure. In atrial fibrillation, most of the abnormal arrhythmogenic foci are located inside the pulmonary veins, although the atrium may also be responsible for triggering or perpetuating atrial fibrillation. Ventricular tachycardia, often found in patients with ischemic heart disease and a history of myocardial infarction, is often life-threatening; it accounts for about 50% of sudden deaths.
Treatment of Tachycardia
The first line of treatment for tachycardia is antiarrhythmic drugs; for atrial fibrillation, anticoagulation drugs are also used to prevent stroke. For patients refractory to or unable to tolerate antiarrhythmic drugs, ablation of the arrhythmogenic heart tissues is the only option. Surgical ablation such as the Cox-Maze procedure is more invasive. Catheter ablation, involving the delivery of energy (most commonly radiofrequency) via a percutaneous catheter system guided by X-ray fluoroscopy, has been used in place of surgical ablation for many patients. However, this conventional approach in catheter ablation has not been found to be effective for the treatment of complex arrhythmias such as chronic atrial fibrillation or ventricular tachycardia. Advanced nonfluoroscopic mapping systems have been developed for guiding the ablation of these complex arrhythmias.
The Technology
Four nonfluoroscopic advanced mapping systems have been licensed by Health Canada:
CARTO EP mapping System (manufactured by Biosense Webster, CA) uses weak magnetic fields and a special mapping/ablation catheter with a magnetic sensor to locate the catheter and reconstruct a 3-dimensional geometry of the heart superimposed with colour-coded electric potential maps to guide ablation.
EnSite System (manufactured by Endocardial Solutions Inc., MN) includes a multi-electrode non-contact catheter that conducts simultaneous mapping. A processing unit uses the electrical data to computes more than 3,000 isopotential electrograms that are displayed on a reconstructed 3-dimensional geometry of the heart chamber. The navigational system, EnSite NavX, can be used separately with most mapping catheters.
The LocaLisa Intracardiac System (manufactured by Medtronics Inc, MN) is a navigational system that uses an electrical field to locate the mapping catheter. It reconstructs the location of the electrodes on the mapping catheter in 3-dimensional virtual space, thereby enabling an ablation catheter to be directed to the electrode that identifies abnormal electric potential.
Polar Constellation Advanced Mapping Catheter System (manufactured by Boston Scientific, MA) is a multielectrode basket catheter with 64 electrodes on 8 splines. Once deployed, each electrode is automatically traced. The information enables a 3-dimensional model of the basket catheter to be computed. Colour-coded activation maps are reconstructed online and displayed on a monitor. By using this catheter, a precise electrical map of the atrium can be obtained in several heartbeats.
Review Strategy
A systematic search of Cochrane, MEDLINE and EMBASE was conducted to identify studies that compared ablation guided by any of the advanced systems to fluoroscopy-guided ablation of tachycardia. English-language studies with sample sizes greater than or equal to 20 that were published between 2000 and 2005 were included. Observational studies on safety of advanced mapping systems and fluoroscopy were also included. Outcomes of interest were acute success, defined as termination of arrhythmia immediately following ablation; long-term success, defined as being arrhythmia free at follow-up; total procedure time; fluoroscopy time; radiation dose; number of radiofrequency pulses; complications; cost; and the cost-effectiveness ratio.
Quality of the individual studies was assessed using established criteria. Quality of the overall evidence was determined by applying the GRADE evaluation system. (3) Qualitative synthesis of the data was performed. Quantitative analysis using Revman 4.2 was performed when appropriate.
Quality of the Studies
Thirty-four studies met the inclusion criteria. These comprised 18 studies on CARTO (4 randomized controlled trials [RCTs] and 14 non-RCTs), 3 RCTs on EnSite NavX, 4 studies on LocaLisa Navigational System (1 RCT and 3 non-RCTs), 2 studies on EnSite and CARTO, 1 on Polar Constellation basket catheter, and 7 studies on radiation safety.
The quality of the studies ranged from moderate to low. Most of the studies had small sample sizes with selection bias, and there was no blinding of patients or care providers in any of the studies. Duration of follow-up ranged from 6 weeks to 29 months, with most having at least 6 months of follow-up. There was heterogeneity with respect to the approach to ablation, definition of success, and drug management before and after the ablation procedure.
Summary of Findings
Evidence is based on a small number of small RCTS and non-RCTS with methodological flaws.
Advanced nonfluoroscopy mapping/navigation systems provided real time 3-dimensional images with integration of anatomic and electrical potential information that enable better visualization of areas of interest for ablation
Advanced nonfluoroscopy mapping/navigation systems appear to be safe; they consistently shortened the fluoroscopy duration and radiation exposure.
Evidence suggests that nonfluoroscopy mapping and navigation systems may be used as adjuncts to rather than replacements for fluoroscopy in guiding the ablation of complex arrhythmias.
Most studies showed a nonsignificant trend toward lower overall failure rate for advanced mapping-guided ablation compared with fluoroscopy-guided mapping.
Pooled analyses of small RCTs and non-RCTs that compared fluoroscopy- with nonfluoroscopy-guided ablation of atrial fibrillation and atrial flutter showed that advanced nonfluoroscopy mapping and navigational systems:
Yielded acute success rates of 69% to 100%, not significantly different from fluoroscopy ablation.
Had overall failure rates at 3 months to 19 months of 1% to 40% (median 25%).
Resulted in a 10% relative reduction in overall failure rate for advanced mapping guided-ablation compared to fluoroscopy guided ablation for the treatment of atrial fibrillation.
Yielded added benefit over fluoroscopy in guiding the ablation of complex arrhythmia. The advanced systems were shown to reduce the arrhythmia burden and the need for antiarrhythmic drugs in patients with complex arrhythmia who had failed fluoroscopy-guided ablation
Based on predominantly observational studies, circumferential PV ablation guided by a nonfluoroscopy system was shown to do the following:
Result in freedom from atrial fibrillation (with or without antiarrhythmic drug) in 75% to 95% of patients (median 79%). This effect was maintained up to 28 months.
Result in freedom from atrial fibrillation without antiarrhythmic drugs in 47% to 95% of patients (median 63%).
Improve patient survival at 28 months after the procedure as compared with drug therapy.
Require special skills; patient outcomes are operator dependent, and there is a significant learning curve effect.
Complication rates of pulmonary vein ablation guided by an advanced mapping/navigation system ranged from 0% to 10% with a median of 6% during a follow-up period of 6 months to 29 months.
The complication rate of the study with the longest follow-up was 8%.
The most common complications of advanced catheter-guided ablation were stroke, transient ischemic attack, cardiac tamponade, myocardial infarction, atrial flutter, congestive heart failure, and pulmonary vein stenosis. A small number of cases with fatal atrial-esophageal fistula had been reported and were attributed to the high radiofrequency energy used rather than to the advanced mapping systems.
Economic Analysis
An Ontario-based economic analysis suggests that the cumulative incremental upfront costs of catheter ablation of atrial fibrillation guided by advanced nonfluoroscopy mapping could be recouped in 4.7 years through cost avoidance arising from less need for antiarrhythmic drugs and fewer hospitalization for stroke and heart failure.
Expert Opinion
Expert consultants to the Medical Advisory Secretariat noted the following:
Nonfluoroscopy mapping is not necessary for simple ablation procedures (e.g., typical flutter). However, it is essential in the ablation of complex arrhythmias including these:
Symptomatic, drug-refractory atrial fibrillation
Arrhythmias in people who have had surgery for congenital heart disease (e.g., macro re-entrant tachycardia in people who have had surgery for congenital heart disease).
Ventricular tachycardia due to myocardial infarction
Atypical atrial flutter
Advanced mapping systems represent an enabling technology in the ablation of complex arrhythmias. The ablation of these complex cases would not have been feasible or advisable with fluoroscopy-guided ablation and, therefore, comparative studies would not be feasible or ethical in such cases.
Many of the studies included patients with relatively simple arrhythmias (e.g., typical atrial flutter and atrial ventricular nodal re-entrant tachycardia), for which the success rates using the fluoroscopy approach were extremely high and unlikely to be improved upon using nonfluoroscopic mapping.
By age 50, almost 100% of people who have had surgery for congenital heart disease will develop arrhythmia.
Some centres are under greater pressure because of expertise in complex ablation procedures for subsets of patients.
The use of advanced mapping systems requires the support of additional electrophysiologic laboratory time and nursing time.
For patients suffering from symptomatic, drug-refractory atrial fibrillation and are otherwise healthy, catheter ablation offers a treatment option that is less invasive than is open surgical ablation.
Small RCTs that may have been limited by type 2 errors showed significant reductions in fluoroscopy exposure in nonfluoroscopy-guided ablation and a trend toward lower overall failure rate that did not reach statistical significance.
Pooled analysis suggests that advanced mapping systems may reduce the overall failure rate in the ablation of atrial fibrillation.
Observational studies suggest that ablation guided by complex mapping/navigation systems is a promising treatment for complex arrhythmias such as highly symptomatic, drug-refractory atrial fibrillation for which rate control is not an option
In people with atrial fibrillation, ablation guided by advanced nonfluoroscopy mapping resulted in arrhythmia free rates of 80% or higher, reduced mortality, and better quality of life at experienced centres.
Although generally safe, serious complications such as stroke, atrial-esophageal, and pulmonary vein stenosis had been reported following ablation procedures.
Experts advised that advanced mapping systems are also required for catheter ablation of:
Hemodynamically unstable ventricular tachycardia from ischemic heart disease
Macro re-entrant atrial tachycardia after surgical correction of congenital heart disease
Atypical atrial flutter
Catheter ablation of atrial fibrillation is still evolving, and it appears that different ablative techniques may be appropriate depending on the characteristics of the patient and the atrial fibrillation.
Data from centres that perform electrophysiological mapping suggest that patients with drug-refractory atrial fibrillation may be the largest group with unmet need for advanced mapping-guided catheter ablation in Ontario.
Nonfluoroscopy mapping-guided pulmonary vein ablation for the treatment of atrial fibrillation has a significant learning effect; therefore, it is advisable for the province to establish centres of excellence to ensure a critical volume, to gain efficiency and to minimize the need for antiarrhythmic drugs after ablation and the need for future repeat ablation procedures.
PMCID: PMC3379531  PMID: 23074499
2.  Retrospective analysis of radiation exposure during endoscopic retrograde cholangiopancreatography: Critical determinants 
Although the risk of radiation-induced spontaneous malignancy and genetic anomalies from occupational radiological procedures is relatively low – and perhaps slightly lower still for the general population – patients and endoscopists in particular, should be aware of the cumulative risk associated with all exposure. Radiation dose has a direct linear relationship with fluoroscopy duration; therefore, limiting fluoroscopy time is one of the most modifiable methods of reducing exposure during fluoroscopic procedures. This retrospective study analyzed more than 1000 endoscopic retrograde cholangiopancreatography procedures and aimed to determine the specific patient, physician and procedural factors that affect fluoroscopy duration.
Fluoroscopy during endoscopic retrograde cholangiopancreatography (ERCP) has a logarithmic relationship with radiation exposure, and carries a known risk of radiation exposure to patients and staff. Factors associated with prolonged fluoroscopy duration have not been well delineated.
To determine the specific patient, physician and procedural factors that affect fluoroscopy duration.
A retrospective analysis of 1071 ERCPs performed at two tertiary care referral hospitals over an 18-month period was conducted. Patient, physician and procedural variables were recorded at the time of the procedure.
The mean duration of 969 fluoroscopy procedures was 4.66 min (95% CI 4.38 to 4.93). Multivariable analysis showed that the specific patient factors associated with prolonged fluoroscopy duration included age and diagnosis (both P<0.0001). The endoscopist was found to play an important role in the duration of fluoroscopy (ie, all endoscopists studied had a mean fluoroscopy duration significantly different from the reference endoscopist). In addition, the following procedural variables were found to be significant: number of procedures, basket use, biopsies, papillotomy (all P<0.0001) and use of a tritome (P=0.004). Mean fluoroscopy duration (in minutes) with 95% CIs for different diagnoses were as follows: common bile duct stones (n=443) 5.12 (3.05 to 4.07); benign biliary strictures (n=135) 3.94 (3.26 to 4.63); malignant biliary strictures (n=124) 5.82 (4.80 to 6.85); chronic pancreatitis (n=49) 4.53 (3.44 to 5.63); bile leak (n=26) 3.67 (2.23 to 5.09); and ampullary mass (n=11) 3.88 (1.28 to 6.48). When no pathology was found (n=195), the mean fluoroscopy time was 3.56 min (95% CI 3.05 to 4.07). Comparison using t tests determined that the only two diagnoses for which fluoroscopy duration was significantly different from the reference diagnosis of ‘no pathology found’ were common bile duct stones (P<0.0001) and malignant strictures (P<0.0001).
Factors that significantly affected fluoroscopy duration included age, diagnosis, endoscopist, and the number and nature of procedures performed. Elderly patients with biliary stones or a malignant stricture were likely to require the longest duration of fluoroscopy. These identified variables may help endoscopists predict which procedures are associated with prolonged fluoroscopy duration so that appropriate precautions can be undertaken.
PMCID: PMC3206549  PMID: 22059160
ERCP; Fluoroscopy time; Radiation
3.  Radiation dose to patients during endoscopic retrograde cholangiopancreatography 
Endoscopic retrograde cholangiopancreatography (ERCP) is an important tool for the diagnosis and treatment of the hepatobiliary system. The use of fluoroscopy to aid ERCP places both the patient and the endoscopy staff at risk of radiation-induced injury. Radiation dose to patients during ERCP depends on many factors, and the endoscopist cannot control some variables, such as patient size, procedure type, or fluoroscopic equipment used. Previous reports have demonstrated a linear relationship between radiation dose and fluoroscopy duration. When fluoroscopy is used to assist ERCP, the shortest fluoroscopy time possible is recommended. Pulsed fluoroscopy and monitoring the length of fluoroscopy have been suggested for an overall reduction in both radiation exposure and fluoroscopy times. Fluoroscopy time is shorter when ERCP is performed by an endoscopist who has many years experience of performing ERCP and carried out a large number of ERCPs in the preceding year. In general, radiation exposure is greater during therapeutic ERCP than during diagnostic ERCP. Factors associated with prolonged fluoroscopy have been delineated recently, but these have not been validated.
PMCID: PMC3159502  PMID: 21860683
Endoscopic retrograde cholangiopancreatography; Radiation dose; Fluoroscopy; Radiation exposure; X-ray
4.  Comparison of radiation dose exposure in patients undergoing percutaneous coronary intervention vs. peripheral intervention 
Most endovascular techniques are associated with patient and personal exposure to radiation during the procedure. Ionising radiation can cause deterministic effects, such as skin injury, as well as stochastic effects, which increase the long-term risk of malignancy. Endovascular operators need to be aware of radiation danger and take all necessary steps to minimise the risk to patients and staff. Some procedures, especially percutaneous peripheral artery revascularisation, are associated with increased radiation dose due to time-consuming operations. There is limited data comparing radiation dose during percutaneous coronary intervention (PCI) with percutaneous transluminal angioplasty (PTA) of peripheral arteries.
To compare the radiation dose in percutaneous coronary vs. peripheral interventions in one centre with a uniform system of protection methods.
Material and methods
A total of 352 patients were included in the study. This included 217 patients undergoing PCI (single and multiple stenting) and 135 patients undergoing PTA (in lower extremities, carotid artery, renal artery, and subclavian artery). Radiation dose, fluoroscopy time, and total procedural time were reviewed. Cumulative radiation dose was measured in gray (Gy) units.
The total procedural time was significantly higher in PTA (PCI vs. PTA: 60 (45–85) min vs. 75 (50–100) min), p < 0.001. The radiation dose for PCI procedures was significantly higher in comparison to PTA (PCI vs. PTA: 1.36 (0.83–2.23) Gy vs. 0.27 (0.13–0.46) Gy), p < 0.001. There was no significant difference in the fluoroscopy time (PCI vs. PTA: 12.9 (8.2–21.5) min vs. 14.4 (8.0–22.6) min), p = 0.6. The analysis of correlation between radiation dose and fluoroscopy time in PCI and PTA interventions separately shows a strong correlation in PCI group (r = 0.785). However, a weak correlation was found in PTA group (r = 0.317).
The radiation dose was significantly higher during PCI in comparison to PTA procedures despite comparable fluoroscopy time and longer total procedure time in PTA. Fluoroscopy time is a reliable parameter to control the radiation dose exposure in coronary procedures. The increasing complexity of endovascular interventions has resulted in the increase of radiation dose exposure during PCI procedures.
PMCID: PMC4252332  PMID: 25489329
radiation dose exposure; fluoroscopy time; peripheral intervention; percutaneous transluminal angioplasty; percutaneous coronary intervention
5.  Risk of whole body radiation exposure and protective measures in fluoroscopically guided interventional techniques: a prospective evaluation 
BMC Anesthesiology  2003;3:2.
Fluoroscopic guidance is frequently utilized in interventional pain management. The major purpose of fluoroscopy is correct needle placement to ensure target specificity and accurate delivery of the injectate. Radiation exposure may be associated with risks to physician, patient and personnel. While there have been many studies evaluating the risk of radiation exposure and techniques to reduce this risk in the upper part of the body, the literature is scant in evaluating the risk of radiation exposure in the lower part of the body.
Radiation exposure risk to the physician was evaluated in 1156 patients undergoing interventional procedures under fluoroscopy by 3 physicians. Monitoring of scattered radiation exposure in the upper and lower body, inside and outside the lead apron was carried out.
The average exposure per procedure was 12.0 ± 9.8 seconds, 9.0 ± 0.37 seconds, and 7.5 ± 1.27 seconds in Groups I, II, and III respectively. Scatter radiation exposure ranged from a low of 3.7 ± 0.29 seconds for caudal/interlaminar epidurals to 61.0 ± 9.0 seconds for discography. Inside the apron, over the thyroid collar on the neck, the scatter radiation exposure was 68 mREM in Group I consisting of 201 patients who had a total of 330 procedures with an average of 0.2060 mREM per procedure and 25 mREM in Group II consisting of 446 patients who had a total of 662 procedures with average of 0.0378 mREM per procedure. The scatter radiation exposure was 0 mREM in Group III consisting of 509 patients who had a total 827 procedures. Increased levels of exposures were observed in Groups I and II compared to Group III, and Group I compared to Group II.
Groin exposure showed 0 mREM exposure in Groups I and II and 15 mREM in Group III. Scatter radiation exposure for groin outside the apron in Group I was 1260 mREM and per procedure was 3.8182 mREM. In Group II the scatter radiation exposure was 400 mREM and with 0.6042 mREM per procedure. In Group III the scatter radiation exposure was 1152 mREM with 1.3930 mREM per procedure.
Results of this study showed that scatter radiation exposure to both the upper and lower parts of the physician's body is present. Protection was offered by traditional measures to the upper body only.
PMCID: PMC194671  PMID: 12904269
6.  Ulcerated Radiodermatitis Induced after Fluoroscopically Guided Stent Implantation Angioplasty 
Cases of radiation-induced skin injury after fluoroscopically guided procedures have been reported since 1996, though the majority of them have been published in Radiology and Cardiology literature, less frequently in Dermatology journals. Chronic radiation dermatitis induced by fluoroscopy can be difficult to diagnose; a high grade of suspicion is required. We report a case of an obese 46-year-old man with hypertension, dyslipidemia, and severe coronary artery disease. He developed a pruritic and painful atrophic ulcerated skin plaque over his left scapula, six months after fluoroscopically guided stent implantation angioplasty. The diagnosis of radiodermatitis was confirmed histologically. We report this case to emphasize the importance of recognizing fluoroscopy as a cause of radiation dermatitis. A good clinical follow-up at regular intervals is important after long and complicated procedures, since the most prevalent factor for injury is long exposure time.
PMCID: PMC4168146  PMID: 25276441
7.  Comparing radiation exposure during percutaneous vertebroplasty using one- vs. two-fluoroscopic technique 
Percutaneous vertebroplasty (PV) requires relatively lengthy fluoroscopic guidance, which might lead to substantial radiation exposure to patients or operators. The two-fluoroscopic technique (two-plane radiographs obtained using two fluoroscopes) during PV can provide simultaneous two-planar projections with reducing operative time. However, the two-fluoroscopic technique may expose the operator or patient to increased radiation dose. The aim of this study was to quantify the amount of radiation exposure to the patient or operator that occurs during PV using one- vs. two-fluoroscopic technique.
Two radiation dosimeters were placed on the right flank of each patient and on the upper sternum of each operator during 26 single-level PV procedures by one senior surgeon. The use of two-fluoroscopic technique (13 patients) and one-fluoroscopic technique (13 patients) were allocated in a consecutive and alternative manner. The operative time and mean radiation dose to each patient and operator were monitored and compared between groups.
Mean radiation dose to the patient was 1.97 ± 1.20 mSv (95% CI, 0.71 to 3.23) for the one-fluoroscopic technique group vs. 0.95 ± 0.34 mSv (95% CI, 0.85 to 1.23) for the two-fluoroscopic technique group (P =0.031). Mean radiation dose to the operator was 0.27 ± 0.12 mSv (95% CI, 0.17–0.56) for the one-fluoroscopic technique group vs. 0.25 ± 0.14 mSv (95% CI, 0.06–0.44) for the two-fluoroscopic technique group (P = 0.653). The operative time was significantly different between groups: 47.15 ± 13.48 min (range, 20–75) for the one-fluoroscopic technique group vs. 36.62 ± 8.42 min (range, 21–50) for the two-fluoroscopic technique group (P =0.019).
Compared to the one-fluoroscopic technique, the two-fluoroscopic technique used during PV provides not only shorter operative times but also reduces the radiation exposure to the patient. There was no significant difference between the two techniques with regards to radiation exposure to the operator.
PMCID: PMC3557160  PMID: 23339360
Vertebral compression fracture; Osteoporosis; Vertebroplasty; Radiation dose
8.  Minimally invasive percutaneous transpedicular screw fixation: increased accuracy and reduced radiation exposure by means of a novel electromagnetic navigation system 
Acta Neurochirurgica  2010;153(3):589-596.
Minimally invasive percutaneous pedicle screw instrumentation methods may increase the need for intraoperative fluoroscopy, resulting in excessive radiation exposure for the patient, surgeon, and support staff. Electromagnetic field (EMF)-based navigation may aid more accurate placement of percutaneous pedicle screws while reducing fluoroscopic exposure. We compared the accuracy, time of insertion, and radiation exposure of EMF with traditional fluoroscopic percutaneous pedicle screw placement.
Minimally invasive pedicle screw placement in T8 to S1 pedicles of eight fresh-frozen human cadaveric torsos was guided with EMF or standard fluoroscopy. Set-up, insertion, and fluoroscopic times and radiation exposure and accuracy (measured with post-procedural computed tomography) were analyzed in each group.
Sixty-two pedicle screws were placed under fluoroscopic guidance and 60 under EMF guidance. Ideal trajectories were achieved more frequently with EMF over all segments (62.7% vs. 40%; p = 0.01). Greatest EMF accuracy was achieved in the lumbar spine, with significant improvements in both ideal trajectory and reduction of pedicle breaches over fluoroscopically guided placement (64.9% vs. 40%, p = 0.03, and 16.2% vs. 42.5%, p = 0.01, respectively). Fluoroscopy time was reduced 77% with the use of EMF (22 s vs. 5 s per level; p < 0.0001) over all spinal segments. Radiation exposure at the hand and body was reduced 60% (p = 0.058) and 32% (p = 0.073), respectively. Time for insertion did not vary between the two techniques.
Minimally invasive pedicle screw placement with the aid of EMF image guidance reduces fluoroscopy time and increases placement accuracy when compared with traditional fluoroscopic guidance while adding no additional time to the procedure.
PMCID: PMC3040822  PMID: 21153669
Minimally invasive; Electromagnetic field navigation; Pedicle screw; Fluoroscopy; Accuracy
9.  Minimizing radiation injury and neoplastic effects during pediatric fluoroscopy: what should we know? 
Pediatric Radiology  2006;36(Suppl 2):141-145.
Radiation-induced injuries from fluoroscopic procedures in pediatric patients have occurred, and young patients are at greatest risk of many radiation-induced neoplasms. Some fluoroscopists have been injured from their use of fluoroscopy, and they are known to be at risk of radiation-induced neoplasm when radiation is not well-controlled. This article reviews the circumstances that lead to radiation injury and delineates some procedural methods to avoid injury and limit radiation exposure to both the patient and the fluoroscopist.
PMCID: PMC2663639  PMID: 16862420
Radiation injury; Fluoroscopic procedures; Patient exposure; Fluoroscopist exposure
10.  Radiation risk from fluoroscopically-assisted anterior cruciate ligament reconstruction 
Precise tunnel positioning is crucial for success in anterior cruciate ligament (ACL) reconstruction. The use of intra-operative fluoroscopy has been shown to improve the accuracy of tunnel placement. Although radiation exposure is a concern, we lack information on the radiation risk to patients undergoing fluoroscopically-assisted ACL reconstruction with a standard C-arm. The aim of our study was to determine the mean radiation doses received by our patients.
Radiation doses were recorded for 18 months between 1 April 2007 and 30 September 2008 for 58 consecutive patients undergoing ACL reconstruction assisted by intra-operative fluoroscopy. Dose area product (DAP) values were used to calculate the entrance skin dose (ESD), an indicator of potential skin damage and the effective dose (ED), an indicator of long-term cancer risk, for each patient.
The median age of 58 patients included in data analysis was 28 years (range, 14–52 years), of whom 44 were male (76%). The mean ESD during intra-operative fluoroscopy was 0.0015 ± 0.0029 Gy. The mean ED was 0.001 ± 0.002 mSv. No results exceeded the threshold of 2 Gy for skin damage, and the life-time risk of developing new cancer due to intra-operative fluoroscopy is less than 0.0001%.
Radiation doses administered during fluoroscopically-assisted ACL reconstruction were safe and do not represent a contra-indication to the procedure.
PMCID: PMC3025191  PMID: 20501019
Anterior cruciate ligament; Reconstruction; Intra-operative fluoroscopy; Radiation dose; Radiation risk
11.  Practical Protective Tools for Occupational Exposure: 
Interventional Neuroradiology  2001;6(Suppl 1):33-42.
Two practical protective tools for occupational exposure for neurointerventional radiologists are presented. The first purpose of this study was to investigate the effectiveness of double focus spectacles for the aged with a highly refracted glass lens (special spectacles for the aged) for radiation protection of the crystalline lens of the eye in comparison with other spectacles on the market, based on the measurement of film density which was obtained by exposure of X-ray through those spectacles. As a result of the film densitometry mentioned above, the effectiveness of special spectacles for the aged in radiation protection was nearly equal to the effectiveness of a goggle type shield which is made with a 0.07 mm lead-equivalent plastic lens.
The second purpose of this study was to investigate the effectiveness of the protective barrier; which we remodeled for cerebral angiography or neuroendovascular therapy, for radiation exposure, based on the measurement in a simulated study with a head phantom, and on the measurement of radiation exposure in operaters during procedures of clinical cases. In the experimental study radiation exposure in supposed position of the crystalline lens was reduced to about one third and radiation exposure in supposed position of the gonadal glands was reduced to about one seventh, compared to radiation exposure without employing the barrier.
The radiation exposure was monitored at the left breast of three radiologists, in 215 cases of cerebral angiography. Employing the barrier in cerebral angiography, average equivalent dose at the left breast measured 1.49µ Sv during 10 min of fluoroscopy. In three kinds of neuroendovascular therapy in 40 cases, radiation exposure in an operator was monitored in the same fashion and the dose was recorded less than the result reported in previous papers in which any protective barrier have not been employed in the procedure1,2.
As a result, the two above mentioned protective tools are considered practical in clinical usage and very effective to reduce radiation exposure in an operator of interventional neuroradiolgy which may sometimes require many hours to complete the therapy under extended fluoroscopic time.
PMCID: PMC3685933  PMID: 20667219
occupational exposure, radiation protection, crystalline lens of eye, barrier against X-ray exposure, cerebral angiography, interventional neuroradiology
12.  Survey of terminology used for the intraoperative direction of C-arm fluoroscopy 
Canadian Journal of Surgery  2013;56(2):109-112.
Orthopedic surgeons depend on the intraoperative use of fluoroscopy to facilitate procedures across all subspecialties. The versatility of the C-arm fluoroscope allows acquisition of nearly any radiographic view. This versatility, however, creates the opportunity for difficulty in communication between surgeon and radiation technologist. Poor communication leads to delays, frustration and increased exposure to ionizing radiation. There is currently no standard terminology employed by surgeons and technologists with regards to direction of the fluoroscope.
The investigation consisted of a web-based survey in 2 parts. Part 1 was administered to the membership of the Canadian Orthopedic Association, part 2 to the membership of the Canadian Association of Medical Radiation Technologists. The survey consisted of open-ended or multiple-choice questions examining experience with the C-arm fluoroscope and the terminology preferred by both orthopedic surgeons and radiation technologists.
The survey revealed tremendous inconsistency in language used by orthopedic surgeons and radiation technologists. It also revealed that many radiation technologists were inexperienced in operating the fluoroscope.
Adoption of a common language has been demonstrated to increase efficiency in performing defined tasks with the fluoroscope. We offer a potential system to facilitate communication based on current terminology used among Canadian orthopedic surgeons and radiation technologists.
PMCID: PMC3617115  PMID: 23351496
13.  Radiation doses to ERCP patients are significantly lower with experienced endoscopists 
Gastrointestinal endoscopy  2010;72(1):58-65.
Patients undergoing ERCP receive nontrivial doses of radiation, which may increase their risk of developing cancer, especially young patients. Radiation doses to patients during ERCP correlate closely with fluoroscopy time.
The aim of this study was to determine whether endoscopist experience is associated with fluoroscopy time.
Retrospective analysis of a prospectively collected database.
Data from 69 providers from 6 countries.
9,052 entries of patients undergoing ERCP.
Main Outcome Measurements
Percent difference in fluoroscopy time associated with endoscopist experience and fellow involvement.
For procedure types that require less fluoroscopy time, compared with endoscopists who performed > 200 ERCPs in the preceding year, endoscopists who performed < 100 and 100 to 200 ERCPs had 104% (95% confidence interval [CI], 85%–124%) and 27% (95% CI, 20%–35%) increases in fluoroscopy time, respectively. Every 10 years of experience was associated with a 21% decrease in fluoroscopy time (95% CI, 19%–24%). For fluoroscopy-intense procedures, compared with endoscopists who performed > 200 ERCPs in the preceding year, endoscopists who performed < 100 and 100 to 200 ERCPs had 59% (95% CI, 39%–82%) and 11% (95% CI, 3%–20%) increases in fluoroscopy time, respectively. Every 10 years of experience was associated with a 20% decrease in fluoroscopy time (95% CI, 18%–24%).
Database used is a voluntary reporting system, which may not be generalizable. Data is self-reported and was not verified for accuracy.
Fluoroscopy time is shorter when ERCP is performed by endoscopists with more years of performing ERCP and a greater number of ERCPs in the preceding year. These findings may have important ramifications for radiation-induced cancer risk.
PMCID: PMC2906113  PMID: 20421102
14.  Pediatric interventional radiography equipment: safety considerations 
Pediatric Radiology  2006;36(Suppl 2):126-135.
This paper discusses pediatric image quality and radiation dose considerations in state-of-the-art fluoroscopic imaging equipment. Although most fluoroscopes are capable of automatically providing good image quality on infants, toddlers, and small children, excessive radiation dose levels can result from design deficiencies of the imaging device or inappropriate configuration of the equipment’s capabilities when imaging small body parts. Important design features and setup choices at installation and during the clinical use of the imaging device can improve image quality and reduce radiation exposure levels in pediatric patients. Pediatric radiologists and cardiologists, with the help of medical physicists, need to understand the issues involved in creating good image quality at reasonable pediatric patient doses. The control of radiographic technique factors by the generator of the imaging device must provide a large dynamic range of mAs values per exposure pulse during both fluoroscopy and image recording as a function of patient girth, which is the thickness of the patient in the posterior–anterior projection at the umbilicus (less than 10 cm to greater than 30 cm). The range of pulse widths must be limited to less than 10 ms in children to properly freeze patient motion. Variable rate pulsed fluoroscopy can be leveraged to reduce radiation dose to the patient and improve image quality. Three focal spots with nominal sizes of 0.3 mm to 1 mm are necessary on the pediatric unit. A second, lateral imaging plane might be necessary because of the child’s limited tolerance of contrast medium. Spectral and spatial beam shaping can improve image quality while reducing the radiation dose. Finally, the level of entrance exposure to the image receptor of the fluoroscope as a function of operator choices, of added filter thickness, of selected pulse rate, of the selected field-of-view and of the patient girth all must be addressed at installation.
PMCID: PMC2663646  PMID: 16862405
Radiation exposure; Fluoroscopic equipment; Equipment settings
15.  Radiation exposure from fluoroscopy during fixation of hip fracture and fracture of ankle: Effect of surgical experience 
Indian Journal of Orthopaedics  2008;42(4):471-473.
Over the years, there has been a tremendous increase in the use of fluoroscopy in orthopaedics. The risk of contracting cancer is significantly higher for an orthopedic surgeon. Hip and spine surgeries account for 99% of the total radiation dose. The amount of radiation to patients and operating surgeon depends on the position of the patient and the type of protection used during the surgery. A retrospective study to assess the influence of the radiation exposure of the operating surgeon during fluoroscopically assisted fixation of fractures of neck of femur (dynamic hip screw) and ankle (Weber B) was performed at a district general hospital in the United Kingdom.
Materials and Methods:
Sixty patients with undisplaced intertrochanteric fracture were included in the hip group, and 60 patients with isolated fracture of lateral malleolus without communition were included in the ankle group. The hip and ankle groups were further divided into subgroups of 20 patients each depending on the operative experience of the operating surgeon. All patients had fluoroscopically assisted fixation of fracture by the same approach and technique. The radiation dose and screening time of each group were recorded and analyzed.
The radiation dose and screening time during fluoroscopically assisted fixation of fracture neck of femur were significantly high with surgeons and trainees with less than 3 years of surgical experience in comparison with surgeons with more than 10 years of experience. The radiation dose and screening time during fluoroscopically assisted fixation of Weber B fracture of ankle were relatively independent of operating surgeon's surgical experience.
The experience of operating surgeon is one of the important factors affecting screening time and radiation dose during fluoroscopically assisted fixation of fracture neck of femur. The use of snapshot pulsed fluoroscopy and involvement of senior surgeons could significantly reduce the radiation dose and screening time.
PMCID: PMC2740341  PMID: 19753238
Experience; fixation; fracture; radiation; surgeon
16.  MR fluoroscopy in vascular and cardiac interventions (review) 
Vascular and cardiac disease remains a leading cause of morbidity and mortality in developed and emerging countries. Vascular and cardiac interventions require extensive fluoroscopic guidance to navigate endovascular catheters. X-ray fluoroscopy is considered the current modality for real time imaging. It provides excellent spatial and temporal resolution, but is limited by exposure of patients and staff to ionizing radiation, poor soft tissue characterization and lack of quantitative physiologic information. MR fluoroscopy has been introduced with substantial progress during the last decade. Clinical and experimental studies performed under MR fluoroscopy have indicated the suitability of this modality for: delivery of ASD closure, aortic valves, and endovascular stents (aortic, carotid, iliac, renal arteries, inferior vena cava). It aids in performing ablation, creation of hepatic shunts and local delivery of therapies. Development of more MR compatible equipment and devices will widen the applications of MR-guided procedures. At post-intervention, MR imaging aids in assessing the efficacy of therapies, success of interventions. It also provides information on vascular flow and cardiac morphology, function, perfusion and viability. MR fluoroscopy has the potential to form the basis for minimally invasive image–guided surgeries that offer improved patient management and cost effectiveness.
PMCID: PMC3275732  PMID: 21359519
Cardiac imaging; Magnetic resonance imaging; Vascular imaging
17.  Assessing radiation exposure during endoscopic-guided percutaneous nephrolithotomy 
Percutaneous nephrolithotomy (PCNL) may be associated with significant ionizing radiation exposure for patients and operating room staff. Endoscopic-guided PCNL (ePCNL) is a technique that may be associated with less radiation exposure. This study examines ePCNL-related radiation exposure (fluoroscopy time, effective dose) and investigates variables that may predict increased exposure.
A retrospective review of all consecutive ePCNLs performed at our institution, by a single surgeon, was conducted between November 2011 and November 2013. Patient demographics, stone characteristics and perioperative details were recorded, including radiation exposure. Pearson and Spearman correlation were used to assess variables correlated with radiation exposure.
In total, 55 ePCNL cases were included in the study. The mean age was 60 ± 15 years, mean body mass index (BMI) 30.0 ± 6.4 kg/m2 and mean stone size 3.2 × 2.1 cm. Seven cases (13%) involved complete staghorn stones, and 69% involved supracostal punctures. The mean fluoroscopy time was 3.4 ± 2.3 minutes, mean ED 2.4 ± 1.9 mSv. The treatment success rate, assessed 1-week postoperatively, was 87.3% and 7.3% of cases required ancillary procedures. The overall complication rate was 29%, but only 3 cases (5.5%) were Clavien ≥3. Longer fluoroscopy time correlated with increased stone size (p < 0.01), longer operative time (p < 0.01) and lower treatment success rates (p < 0.01); higher effective dose correlated with longer fluoroscopy time (p < 0.01) and increased skin-to-stone distance (p < 0.01). BMI did not correlate with fluoroscopy time or effective dose.
Outcomes of ePCNL are comparable to traditional PCNL techniques and may be associated with lower radiation exposure, particularly beneficial for patients with higher BMI.
PMCID: PMC4216293  PMID: 25408802
18.  Potential Increased Risk of Ischemic Heart Disease Mortality With Significant Dose Fractionation in the Canadian Fluoroscopy Cohort Study 
American Journal of Epidemiology  2013;179(1):120-131.
Risks of noncancer causes of death, particularly cardiovascular disease, associated with exposures to high-dose ionizing radiation, are well known. Recent studies have reported excess risk in workers who are occupationally exposed to low doses at a low dose rate, but the risks of moderately fractionated exposures, such as occur during diagnostic radiation procedures, remain unclear. The Canadian Fluoroscopy Cohort Study includes 63,707 tuberculosis patients exposed to multiple fluoroscopic procedures in 1930–1952 and followed-up for death from noncancer causes in 1950–1987. We used a Poisson regression to estimate excess relative risk (ERR) per Gy of cumulative radiation dose to the lung (mean dose = 0.79 Gy; range, 0–11.60). The risk of death from noncancer causes was significantly lower in these subjects compared with the Canadian general population (P < 0.001). We estimated small, nonsignificant increases in the risk of death from noncancer causes with dose. We estimated an ERR/Gy of 0.176 (95% confidence interval: 0.011, 0.393) (n = 5,818 deaths) for ischemic heart disease (IHD) after adjustment for dose fractionation. A significant (P = 0.022) inverse dose fractionation effect in dose trends of IHD was observed, with the highest estimate of ERR/Gy for those with the fewest fluoroscopic procedures per year. Radiation-related risks of IHD decreased significantly with increasing time since first exposure and age at first exposure (both P < 0.05). This is the largest study of patients exposed to moderately fractionated low-to-moderate doses of radiation, and it provides additional evidence of increased radiation-associated risks of death from IHD, in particular, significantly increased radiation risks from doses similar to those from diagnostic radiation procedures. The novel finding of a significant inverse dose-fractionation association in IHD mortality requires further investigation.
PMCID: PMC3864716  PMID: 24145888
cardiovascular disease; dose fractionation; ionizing radiation; ischemic heart disease; noncancer diseases; radiation dose-response relationship
19.  Kyphoplasty: Traditional imaging compared with computer-guided intervention—time to rethink technique? 
Study design: Equivalence trial (IRB not required for cadaveric studies).
Objective: To compare computer-guided and fluoroscopic kyphoplasty. Factors of interest were radiation exposure, position of cannula within pedicles and procedure time.
Methods: Kyphoplasty was performed on two cadavers. Computer-navigated, cross-sectional images from a cone-beam CT were used for one and fluoroscopic imaging for the other. In each, T6–9 and T11–L2 vertebrae were selected. For both imaging methods, anteroposterior and lateral x-rays were taken. Radiation exposure for both procedures was measured by four dosimeters. Procedure time, radiation to surgeon and cadaver, and position of cannula placement within pedicles were recorded. The surgeon wore one under the lead gown, another on the lead gown at shoulder level, and a third as a ring on the dominant hand. A dosimeter was also placed on the cadaver.
Results: The radiation from the cone-beam, computer-guided imaging system was 0.0 mrem to the surgeon and 0.52 rads to the cadaver. Using fluoroscopic imaging, surgeon's and cadaver's exposure was 5 mrem and 0.047 rads, respectively. Procedure times were similar and neither device resulted in cannula malposition.
Conclusions: Cone-beam CT appears as accurate as the fluoroscopy; radiation exposure to the surgeon is eliminated, and radiation levels to the patient are acceptable.
PMCID: PMC3609000  PMID: 23544024
20.  Patient radiation exposure during transcatheter aortic valve replacement procedures 
To describe patient radiation utilisation during transcatheter aortic valve replacement (TAVR) on a series of consecutive patients.
Methods and results
Data on radiation exposure were prospectively collected for consecutive patients undergoing TAVR and percutaneous coronary interventions at our centre. Radiation dose during the procedure was recorded using the US Food and Drug Administration (FDA) reference point (Ka,r) and the dose area product (PKA). In addition to quantifying overall radiation doses during TAVR, radiation exposure during transfemoral (TF) (n=79) and transapical (TA) (n=26) cases was compared. The median radiation dose during TAVR was 1,639 mGy (983–2,420), or 188 (106–321) Gy*cm2. Radiation dose was significantly lower among TA patients using either the reference point (TA: 946 [777–1,261] vs. TF: 1,932 [1,383–2,614] mGy; p<0.001) or the dose area product (TA: 89 [60–115] vs. TF: 236 [164–338] Gy*cm2; p<0.001). Fluoroscopy time was lower for TA patients (TA: 10 [8–11] vs. TF: 30 [24–34] minutes; p<0.001). Operators experience did not affect radiation exposure for TF cases.
Radiation exposure during TAVR appears similar to other percutaneous coronary interventions of moderate complexity. Radiation doses were significantly lower for TA procedures. A higher dose of radiation in TF patients may be related to additional imaging requirements to optimise percutaneous vascular access and closure.
PMCID: PMC3718041  PMID: 23086785
aortic stenosis; radiation; TAVR
21.  Direct coronary stenting in reducing radiation and radiocontrast consumption 
Radiology and Oncology  2010;44(3):153-157.
Coronary stenting is the primary means of coronary revascularization. There are two basic techniques of stent implantation: stenting with balloon predilatation of stenosis and stenting without predilatation (direct stenting). Limiting the time that a fluoroscope is activated and by appropriately managing the intensity of the applied radiation, the operator limits radiation in the environment, and this saves the exposure to the patient and all personnel in the room. Nephrotoxicity is one of the most important properties of radiocontrast. The smaller amount of radiocontrast used also provides multiple positive effects, primarily regarding the periprocedural risk for the patients with the reduced renal function. The goal of the study was to compare fluoroscopy time, the amount of radiocontrast, and expenses of material used in direct stenting and in stenting with predilatation.
Patients and methods
In a prospective study, 70 patients with coronary disease were randomized to direct stenting, or stenting with predilatation.
Fluoroscopy time and radiocontrast use were significantly reduced in the directly stented patients in comparison to the patients stented with balloon-predilatation. The study showed a significant reduction of expenses when using a direct stenting method in comparison to stenting with predilatation.
If the operator predicts that the procedure can be performed using direct stenting, he is encouraged to do so. Direct stenting is recommended for all percutaneous coronary interventions when appropriate conditions have been met. If direct stenting has been unsuccessful, the procedure can be converted to predilatation.
PMCID: PMC3423693  PMID: 22933908
coronary stenting; balloon predilatation; percutaneous transluminal coronary angioplasty; expenses
22.  Management of pediatric radiation dose using GE fluoroscopic equipment 
Pediatric Radiology  2006;36(Suppl 2):204-211.
In this article, we present GE Healthcare’s design philosophy and implementation of X-ray imaging systems with dose management for pediatric patients, as embodied in its current radiography and fluoroscopy and interventional cardiovascular X-ray product offerings. First, we present a basic framework of image quality and dose in the context of a cost–benefit trade-off, with the development of the concept of imaging dose efficiency. A set of key metrics of image quality and dose efficiency is presented, including X-ray source efficiency, detector quantum efficiency (DQE), detector dynamic range, and temporal response, with an explanation of the clinical relevance of each. Second, we present design methods for automatically selecting optimal X-ray technique parameters (kVp, mA, pulse width, and spectral filtration) in real time for various clinical applications. These methods are based on an optimization scheme where patient skin dose is minimized for a target desired image contrast-to-noise ratio. Operator display of skin dose and Dose-Area Product (DAP) is covered, as well. Third, system controls and predefined protocols available to the operator are explained in the context of dose management and the need to meet varying clinical procedure imaging demands. For example, fluoroscopic dose rate is adjustable over a range of 20:1 to adapt to different procedure requirements. Fourth, we discuss the impact of image processing techniques upon dose minimization. In particular, two such techniques, dynamic range compression through adaptive multiband spectral filtering and fluoroscopic noise reduction, are explored in some detail. Fifth, we review a list of system dose-reduction features, including automatic spectral filtration, virtual collimation, variable-rate pulsed fluoroscopic, grid and no-grid techniques, and fluoroscopic loop replay with store. In addition, we describe a new feature that automatically minimizes the patient-to-detector distance, along with an estimate of its dose reduction potential. Finally, two recently developed imaging techniques and their potential effect on dose utilization are discussed. Specifically, we discuss the dose benefits of rotational angiography and low frame rate imaging with advanced image processing in lieu of higher-dose digital subtraction.
PMCID: PMC2663641  PMID: 16862403
Pediatric dose management; Fluoroscopic equipment; Technical advances
23.  Analysis of Gene Expression Using Gene Sets Discriminates Cancer Patients with and without Late Radiation Toxicity 
PLoS Medicine  2006;3(10):e422.
Radiation is an effective anti-cancer therapy but leads to severe late radiation toxicity in 5%–10% of patients. Assuming that genetic susceptibility impacts this risk, we hypothesized that the cellular response of normal tissue to X-rays could discriminate patients with and without late radiation toxicity.
Methods and Findings
Prostate carcinoma patients without evidence of cancer 2 y after curative radiotherapy were recruited in the study. Blood samples of 21 patients with severe late complications from radiation and 17 patients without symptoms were collected. Stimulated peripheral lymphocytes were mock-irradiated or irradiated with 2-Gy X-rays. The 24-h radiation response was analyzed by gene expression profiling and used for classification. Classification was performed either on the expression of separate genes or, to augment the classification power, on gene sets consisting of genes grouped together based on function or cellular colocalization.
X-ray irradiation altered the expression of radio-responsive genes in both groups. This response was variable across individuals, and the expression of the most significant radio-responsive genes was unlinked to radiation toxicity. The classifier based on the radiation response of separate genes correctly classified 63% of the patients. The classifier based on affected gene sets improved correct classification to 86%, although on the individual level only 21/38 (55%) patients were classified with high certainty. The majority of the discriminative genes and gene sets belonged to the ubiquitin, apoptosis, and stress signaling networks. The apoptotic response appeared more pronounced in patients that did not develop toxicity. In an independent set of 12 patients, the toxicity status of eight was predicted correctly by the gene set classifier.
Gene expression profiling succeeded to some extent in discriminating groups of patients with and without severe late radiotherapy toxicity. Moreover, the discriminative power was enhanced by assessment of functionally or structurally related gene sets. While prediction of individual response requires improvement, this study is a step forward in predicting susceptibility to late radiation toxicity.
Expression profiling can discriminate between groups of patients with and without severe late radiotherapy toxicity but not (yet) predict individual responses.
Editors' Summary
More than half the people who develop cancer receive radiotherapy as part of their treatment. That is, tumor cells are destroyed by exposing them to a source of ionizing radiation such as X-rays. Ionizing radiation damages the genetic material of cancer cells so that they can no longer divide. Unfortunately, it also damages nearby normal cells, although they are less sensitive to radiation than the cancer cells. Radiotherapists minimize how much radiation hits normal tissues by carefully aiming the X-rays at the tumor. Even so, patients often develop side effects such as sore skin or digestive problems during or soon after radiotherapy; the exact nature of the side effects depends on the part of the body exposed to the X-rays. In addition, a few patients develop severe late radiation toxicity, months or years after their treatment. Like early toxicity, late toxicity occurs in the normal tissues near the tumor site. For example, in prostate cancer—a tumor that forms in a gland in the male reproductive system that lies between the bladder and the end of the gut (the rectum)—late radiation toxicity affects rectal, bladder, and sexual function in 5%–10% of patients.
Why Was This Study Done?
It is not known why some patients develop late radiation toxicity, and it is impossible to predict before treatment which patients will have long-term health problems after radiotherapy. It would be useful to know this, because radiation levels might be reduced in those patients, while larger doses of radiation could be given to patients at low risk of late complications to ensure a complete eradication of their cancer. One theory is that some patients are genetically predisposed to develop severe late radiation toxicity. In other words, their genetic make-up makes it more likely that their tissues develop long-term complications after radiation damage. In this study, the researchers looked for markers of a genetic predisposition for late radiation toxicity by comparing radiation-induced changes in the pattern of cellular proteins in patients who had late radiation toxicity after radiotherapy with the changes seen in patients who did not develop such complications.
What Did the Researchers Do and Find?
The researchers recruited 38 patients who had been treated successfully with radiotherapy for prostate cancer two years previously. Of these, 21 had developed severe late radiation toxicity. They isolated lymphocytes (a type of immune system cell) from the patients' blood, stimulated the lymphocytes to divide, exposed them to X-rays, and analyzed the pattern of genes active in these cells—their gene expression profile—before and after irradiation. The researchers found that irradiation induced the expression of numerous genes in the lymphocytes, including many well-known radiation-responsive genes. They then used an analytical process called “random cross-validation” to look for a gene expression profile (or molecular signature) that was associated with late radiation toxicity. They report that a signature based on the radiation response of 50 individual genes correctly classified 63% of the patient population in terms of whether the patient had developed late radiation toxicity. A signature based on the radiation response of gene sets containing genes linked by function or cellular localization correctly classified 86% of the patient population.
What Do These Findings Mean?
Gene expression profiling identified groups of patients who had had severe late radiation toxicity pretty well, particularly when sets of related genes were used to classify the patients. The approach was not so good, however, at identifying individual patients who had had problems, being correct and certain only half the time. Additional studies are needed, therefore, before this promising approach can be used clinically to predict patient responses to radiotherapy. Overall, the study supports the idea that some patients are genetically predisposed to develop late radiation toxicity, and it also provides clues about which cellular pathways help to determine late radiation toxicity. Most of the genes and gene sets that discriminated between the patients with and without late radiation toxicity are involved in protein metabolism, apoptosis (a special sort of cell death), and stress signaling networks (pathways that protect cells from damage). This information, if confirmed, might help researchers to develop therapeutic interventions to minimize late radiation toxicity in vulnerable individuals.
Additional Information.
Please access these Web sites via the online version of this summary at
US National Cancer Institute patient information on radiotherapy and on prostate cancer
American Cancer Society information on radiation therapy
Cancer Research UK patient information on radiotherapy
Wikipedia pages on radiotherapy (note that Wikipedia is a free online encyclopedia that anyone can edit)
PMCID: PMC1626552  PMID: 17076557
24.  Automatic Monitoring of Localized Skin Dose with Fluoroscopic and Interventional Procedures 
Journal of Digital Imaging  2010;24(4):626-639.
This software tool locates and computes the intensity of radiation skin dose resulting from fluoroscopically guided interventional procedures. It is comprised of multiple modules. Using standardized body specific geometric values, a software module defines a set of male and female patients arbitarily positioned on a fluoroscopy table. Simulated X-ray angiographic (XA) equipment includes XRII and digital detectors with or without bi-plane configurations and left and right facing tables. Skin dose estimates are localized by computing the exposure to each 0.01 × 0.01 m2 on the surface of a patient irradiated by the X-ray beam. Digital Imaging and Communications in Medicine (DICOM) Structured Report Dose data sent to a modular dosimetry database automatically extracts the 11 XA tags necessary for peak skin dose computation. Skin dose calculation software uses these tags (gantry angles, air kerma at the patient entrance reference point, etc.) and applies appropriate corrections of exposure and beam location based on each irradiation event (fluoroscopy and acquistions). A physicist screen records the initial validation of the accuracy, patient and equipment geometry, DICOM compliance, exposure output calibration, backscatter factor, and table and pad attenuation once per system. A technologist screen specifies patient positioning, patient height and weight, and physician user. Peak skin dose is computed and localized; additionally, fluoroscopy duration and kerma area product values are electronically recorded and sent to the XA database. This approach fully addresses current limitations in meeting accreditation criteria, eliminates the need for paper logs at a XA console, and provides a method where automated ALARA montoring is possible including email and pager alerts.
PMCID: PMC3138926  PMID: 20706859
Peak skin dose; sentinal event; DICOM structured report dose; patient entrance reference point; fluoroscopy; interventional radiology; Joint Commission (JC); radiation dose; Digital Imaging and Communications in Medicine (DICOM)
25.  A Study to Compare the Radiation Absorbed Dose of the C-arm Fluoroscopic Modes 
The Korean Journal of Pain  2011;24(4):199-204.
Although many clinicians know about the reducing effects of the pulsed and low-dose modes for fluoroscopic radiation when performing interventional procedures, few studies have quantified the reduction of radiation-absorbed doses (RADs). The aim of this study is to compare how much the RADs from a fluoroscopy are reduced according to the C-arm fluoroscopic modes used.
We measured the RADs in the C-arm fluoroscopic modes including 'conventional mode', 'pulsed mode', 'low-dose mode', and 'pulsed + low-dose mode'. Clinical imaging conditions were simulated using a lead apron instead of a patient. According to each mode, one experimenter radiographed the lead apron, which was on the table, consecutively 5 times on the AP views. We regarded this as one set and a total of 10 sets were done according to each mode. Cumulative exposure time, RADs, peak X-ray energy, and current, which were viewed on the monitor, were recorded.
Pulsed, low-dose, and pulsed + low-dose modes showed significantly decreased RADs by 32%, 57%, and 83% compared to the conventional mode. The mean cumulative exposure time was significantly lower in the pulsed and pulsed + low-dose modes than in the conventional mode. All modes had pretty much the same peak X-ray energy. The mean current was significantly lower in the low-dose and pulsed + low-dose modes than in the conventional mode.
The use of the pulsed and low-dose modes together significantly reduced the RADs compared to the conventional mode. Therefore, the proper use of the fluoroscopy and its C-arm modes will reduce the radiation exposure of patients and clinicians.
PMCID: PMC3248583  PMID: 22220241
fluoroscopy; radiation; radiation dosage; radiographic image enhancement

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