Off-label-use of sulfur-hexafluoride in voiding urosonography for diagnosis of vesicoureteral reflux in children:A survey on adverse events

AIM To evaluate the risk profile of sulfur hexafluoride in voiding urosonography(VUS) based on a large cohort of children.METHODS Since 2011 sulfur hexafluoride(SH,SonoV ue?,Bracco,Italy) is the only ultrasound contrast available in the European Union and its use in children has not been approved.Within a 4-year-period,531 children with suspected or proven vesicoureteral reflux(f/m = 478/53; mean age 4.9 years; 1 mo-25.2 years) following parental informed consent underwent VUS with administration of 2.6 ± 1.2 mL SH in a two-center study.A standardizedtelephone survey on adverse events was conducted three days later.RESULTS No acute adverse reactions were observed.The survey revealed subacute,mostly self-limited adverse events in 4.1%(22/531).The majority of observed adverse events(17/22) was not suspected to be caused by an allergic reaction: Five were related to catheter placement,three to reactivated urinary tract infections,five were associated with perineal disinfection before voiding urosonography or perineal dermatitis and four with a common cold.In five patients(0.9%) hints to a potential allergic cause were noted: Perineal urticaria was reported in three interviews and isolated,mild fever in two.These were minor self-limited adverse events with a subacute onset and no hospital admittance was necessary.Ninety-six point two percent of the parents would prefer future VUS examinations with use of SH.CONCLUSION No severe adverse events were observed and indications of self-limited minor allergic reactions related to intravesical administration of SH were reported in less than 1%.

Comparative study of conventional urosonography without contrast enhancement and x-ray voiding cystourethrography for diagnosis of vesicoureteral reflux in children

Background:Vesicoureteral reflux is the most common urinary congenital anomaly in children.Given the risk associated with radiation exposure there has been an increasing need for radiation-free method in the diagnosis and follow-up of the vesicoureteral reflux.The aim of our study is to compare conventional urosonography without contrast enhancement and x-ray voiding cystourethrography.Patients and Methods:Children with recurrent urinary tract infection with suspected vesicoureteral reflux were included to the study.Vesicoureteral reflux is demonstrated and graded by x-ray voiding cystourethrography.DMSA is used for the evaluation of renal scar.Conventional sonographic procedure was performed in all patients.Ureterovesical junction insertion angle was evaluated.The diameter and length of the ureterovesical junction were also measured.Results:268 children enrolled to the study.Vesicoureteral reflux was demonstrated in 62 children by x-ray voiding cystourethrography.Ureterovesical junction insertion angle measurement had a statistically significant relation for right and left vesicoureteral reflux presence(right:r:.646,p:.01 and left:r:.446,p:.01).Diagnosis sensitivity of vesicoureteral reflux with conventional ultrasonography is 95.10%and specificity is 81%(Youden’s index 76.1%)for the cutoff value of the ureterovesical junction insertion angle is 28.6 degrees.Positive predictive value is 87.2%,negative predictive value is 94.73%and diagnostic accuracy is 86.29%with conventional ultrasonography.Conclusions:Measurement of ureterovesical junction insertion angle,length and diameter by conventional urosonography is an easy accessible and cheap technique with high sensitivity and specificity for the diagnosis and followup of the vesicoureteral reflux without exposure to ionizing radiation.