Purpose To determine whether the use of a magnetic tracking and electrocardiography-guided catheter tip confirmation system (TCS) is safe and noninferior to fluoroscopy concerning positioning accuracy of a peripheral inserted central catheter (PICC). Methods In this prospective, randomized, single-center study, adult patients scheduled for PICC insertion were assigned 1:1 either to TCS or fluoroscopy. The primary objective was a noninferiority comparison of correct PICC tip position confirmed by X-ray obtained immediately after catheter insertion. Time needed for PICC insertion and insertion-related complications up to 14 days after the procedure were secondary outcomes to be assessed for superiority. Results A total of 210 patients (62.3 ± 14.4 years, 63.8% male) were included at a single German center between June 2016 and October 2017. Correct PICC tip position was achieved in 84 of 103 TCS (82.4%) and 103 of 104 fluoroscopy patients (99.0%). One-sided 95% lower confidence limit on the difference between proportions was −23.1%. Thus, noninferiority of TCS was not established (p > 0.99). Insertion of PICC took longer with TCS compared to fluoroscopy (8.4 ± 3.7 min vs. 5.0 ± 2.7 min, p < 0.001). Incidence of complications within a mean follow-up of 5.0 ± 2.3 days did not differ significantly between groups. Conclusion Noninferiority of TCS to fluoroscopy in the incidence of correct PICC tip position was not reached. Ancillary benefit of TCS over fluoroscopy including less radiation exposure and lower resource requirements may nonetheless justify the use of TCS. The study is registered with Clinical.Trials.gov (Identifier: NCT02929368).
Background It is essential to avoid admission of patients with undetected corona virus disease 2019 (COVID-19) to hospitals’ general wards. Even repeated negative reverse transcription polymerase chain reaction (RT-PCR) results do not rule-out COVID-19 with certainty. The study aimed to evaluate a rule-out strategy for COVID-19 using chest computed tomography (CT) in adults being admitted to the emergency department and suspected of COVID-19. Methods In this prospective, single centre, diagnostic accuracy cohort study, consecutive adults (≥ 18 years) presenting with symptoms consistent with COVID-19 or previous contact to infected individuals, admitted to the emergency department and supposed to be referred to general ward were included in March and April 2020. All participants underwent low-dose chest CT. RT-PCR- and specific antibody tests were used as reference standard. Main outcome measures were sensitivity and specificity of chest CT. Predictive values were calculated based on the theorem of Bayes using Fagan’s nomogram. Results Of 165 participants (56.4% male, 71 ± 16 years) included in the study, the diagnosis of COVID-19 was confirmed with RT-PCR and AB tests in 13 participants (prevalence 7.9%). Sensitivity and specificity of chest CT were 84.6% (95% confidence interval [CI], 54.6–98.1) and 94.7% (95% CI, 89.9–97.7), respectively. Positive and negative likelihood ratio of chest CT were 16.1 (95% CI, 7.9–32.8) and 0.16 (95% CI, 0.05–0.58) and positive and negative predictive value were 57.9% (95% CI, 40.3–73.7) and 98.6% (95% CI, 95.3–99.6), respectively. Conclusion At a low prevalence of COVID-19, chest CT could be used as a complement to repeated RT-PCR testing for early COVID-19 exclusion in adults with suspected infection before referral to hospital’s general wards. Trial registration ClinicalTrials.gov: NCT04357938 April 22, 2020.
Purpose To assess radiation exposure in men undergoing prostate artery embolization (PAE) for the treatment for symptomatic, benign prostatic hyperplasia depending on growing experience of interventional radiologists over a 4-year period. Methods A total of 250 consecutive patients underwent PAE at a single center. Data on radiation exposure [dose area product (DAP), effective dose (ED), entrance skin dose (ESD), and fluoroscopy time (FT)] were retrospectively evaluated. Primary outcomes of interest were patient radiation exposure in five consecutive groups of 50 patients each and Pearson correlation with the number of patients treated. Results Median DAP, ED, and ESD during prostate artery embolization were significantly higher in the first compared to the second 50 patients (56 298 µGym 2 vs. 24 709 µGym 2 , p < 0.001, 146.4 mSv vs. 64.2 mSv, p < 0.001, and 5.1 Gy vs. 2.4 Gy, p < 0.001, respectively). The following consecutive groups did not differ significantly from the respective preceding group in terms of DAP, ED, and ESD. Number of digital subtraction angiography series, FT, and procedure time decreased with increasing operator experience (Pearson’s r = − 0.240, p < 0.001, r = − 0.269, p < 0.001, and r = − 0.504, p < 0.001, respectively). Bilateral prostate artery embolization was associated with less ESD and shorter FT than unilateral embolization (median 2.5 vs. 3.5 Gy, p = 0.02, and 26 min vs. 42 min, p < 0.001, respectively). Conclusion Exposure to radiation in men who underwent PAE decreased with growing operator experience and decreasing complexity of procedures.
Purpose To evaluate the effect of cone-beam computed tomography (CBCT) on radiation exposure, procedure time, and contrast media (CM) use in prostatic artery embolization (PAE). Materials and Methods Seventy-eight patients were enrolled in this retrospective, single-center study. All patients received PAE without (group A; n = 39) or with (group B; n = 39) CBCT. Total dose-area product (DAPtotal; Gycm2), total entrance skin dose (ESDtotal; mGy), and total effective dose (EDtotal; mSv) were primary outcomes. Number of digital subtraction angiography (DSA) series, CM use, fluoroscopy time, and procedure time were secondary outcomes. PAE in group A was performed by a single radiologist with 15 years experience, PAE in group B was conducted by four radiologists with 4 to 6 years experience. Results For groups A vs. B, respectively, median (IQR): DAPtotal 236.94 (186.7) vs. 281.20 (214.47) Gycm2(p = 0.345); EDtotal 25.82 (20.35) vs. 39.84 (23.75) mSv (p = < 0.001); ESDtotal 2833 (2278) vs. 2563 (3040) mGy(p = 0.818); number of DSA series 25 (15) vs. 23 (10)(p = 0.164); CM use 65 (30) vs. 114 (40) mL(p = < 0.001); fluoroscopy time 23 (20) vs. 28 (25) min(p = 0.265), and procedure time 70 (40) vs.120 (40) min(p = < 0.001). Bilateral PAE was achieved in 33/39 (84.6%) group A and 32/39 (82.05%) group B(p = 0.761), all other patients received unilateral PAE. There were no significant differences between clinical parameters and origins of the prostatic arteries (PA) (p = 0.206–1.00). Conclusion Operators with extensive expertise on PAE may not benefit from addition of CBCT to DSA runs, whereas for operators with less expertise, CBCT when used alongside with DSA runs increased the overall radiation exposure.
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