A randomized comparison of a novel iopromide-based paclitaxel-coated balloon Shenqi versus SeQuent Please for the treatment of in-stent restenosis.

BACKGROUND: Treatment of coronary in-stent restenosis (ISR) remains challenging in contemporary clinical applications. Drug-coated balloon (DCB) angioplasty offers an effective treatment for ISR. Shenqi is a novel iopromide-based paclitaxel-coated balloon and its clinical safety, effectiveness and angiographic efficacy in patients with ISR have not been investigated. METHODS: A total of 216 subjects with the first occurrence of ISR at 11 investigational sites in China were randomly allocated in a 1:1 fashion to treatment with DCB SeQuent Please or Shenqi. Clinical follow-up was planned at 1, 6, 9 and 12 months, and angiographic follow-up was planned at 9 months. The study was powered for the primary endpoint of 9-month in-segment late loss. RESULTS: At 9-month follow-up, the in-segment late loss was 0.29 ± 0.43 mm with Shenqi versus 0.30 ± 0.46 mm with SeQuent Please, and the one-sided 97.5% upper confidence limit of the difference was 0.14 mm, achieving noninferiority of Shenqi compared with SeQuent Please (P = 0.002). In total, 12 patients developed target lesion failure (TLF) in the Shenqi group compared with 16 patients in the SeQuent Please group (10.91% versus 15.09%; P = 0.42) within 1 year. TLF was mainly driven by target lesion revascularization (9.09%) followed by target vessel-related myocardial infarction (1.82%) and cardiovascular death (0.91%) in the Shenqi group. CONCLUSIONS: Shenqi DCB was noninferior to SeQuent Please DCB for the primary endpoint of 9-month in-segment late loss. Shenqi DCB may become an attractive alternative treatment for patients with coronary ISR, withholding the need for additional stent implantation.

Outcomes of a low-osmolar water-soluble contrast pathway in small bowel obstruction.

BACKGROUND: Adhesive small-bowel obstruction (SBO) is a common surgical condition accounting for a significant proportion of acute surgical admissions and surgeries. The implementation of a high-osmolar water-soluble contrast challenge has repeatedly been shown to reduce hospital length of stay and possibly the need for surgery in SBO patients. The effect of low-osmolar water-soluble contrast challenge however, is unclear. The aim of this study is to evaluate the outcomes of an SBO pathway including a low-osmolar water-soluble contrast challenge. METHODS: A prospective cohort of patients admitted for SBO were placed on an evidence-based SBO pathway including low-osmolar water-soluble contrast between January 2017 and October 2018 and were compared with a historical cohort of patients prior to the implementation of the pathway from September 2013 through December 2014. The primary outcome was length of stay less than 4 days with a secondary outcome of failure of nonoperative management. RESULTS: There were 140 patients enrolled in the SBO pathway during the study period and 101 historic controls. The SBO pathway was independently associated with a length of stay less than 4 days (odds ratio, 1.76; 95% confidence interval, 1.03-3.00). Median length of stay for patients that were successfully managed nonoperatively was lower in the SBO pathway cohort compared with controls (3 days vs. 4 days, p = 0.04). Rates of readmission, surgery, and bowel resection were not significantly different between the two cohorts. CONCLUSION: Implementation of an SBO pathway using a low-osmolarity contrast is associated with decreased hospital length of stay. Rates of readmission, surgery, and need for bowel resection for those undergoing surgery were unchanged. An SBO pathway utilizing low-osmolarity water-soluble contrast is safe and effective in reducing length of stay in the nonoperative management of adhesive small-bowel obstructions. LEVEL OF EVIDENCE: Therapeutic study, level IV.

Iodixanol versus Iopromide at Coronary CT Angiography: Lumen Opacification and Effect on Heart Rhythm-the Randomized IsoCOR Trial.

Purpose To show that equal coronary lumen opacification can be achieved with iso- and low-osmolar contrast media when it is injected at the same iodine delivery rate with contemporary cardiac computed tomographic (CT) protocols and to investigate the cardiovascular effect of iso-osmolar contrast media and the image quality achieved. Materials and Methods Institutional review board approval and written informed consent were obtained for the Effect of Iso-osmolar Contrast Medium on Coronary Opacification and Heart Rhythm in Coronary CT Angiography, or IsoCOR, trial. Between November 2015 and August 2016, 306 patients (167 [55%] women) at least 18 years old (weight range, 50-125 kg), were prospectively randomized to receive iso-osmolar iodixanol 270 or low-osmolar iopromide 300 contrast media. All coronary segments were assessed for intraluminal opacification and image quality and were compared by using the Student t test. Heart rate, arrhythmia, patient discomfort, and adverse events also were monitored. Results Mean measured coronary attenuation values ± standard deviation were comparable between the iodixanol 270 and iopromide 300 contrast media groups (469 HU ± 167 vs 447 HU ± 166, respectively [P = .241]; 95% confidence interval: -15.1, 60.0), including those from subanalyses. Adjusted for the lower iodine concentration, the mean iodixanol 270 bolus was larger compared with that of iopromide 300 (76.8 mL ± 11.6 vs 69.7 mL ± 10.8, respectively; P < .001). The higher injection rate was associated with higher pressure (777 kPa ± 308 vs 630 kPa ± 252, respectively; P < .001). Although in the iodixanol 270 group patients experienced less heat discomfort (72% vs 86%, respectively; P < .001), no differences in heart rate or rhythm were observed. Conclusion If injected at comparable iodine delivery rates, the iso-osmolar contrast medium iodixanol 270 is not inferior to low-osmolar contrast medium iopromide 300 for assessment of coronary opacification. Iodixanol 270 was associated with less heat discomfort, but did not affect heart rate differently compared with iopromide 300. © RSNA, 2017 Online supplemental material is available for this article.

Assessment of EmboGel--a selectively dissolvable radiopaque hydrogel for embolic applications.

PURPOSE: To evaluate the embolic properties of an alginate-based embolic biomaterial (EmboGel) and its solvent (EmboClear) in treatment of aneurysms. MATERIALS AND METHODS: EmboGel is a mixture of iohexol and alginate that polymerizes into a hydrocoil when delivered through a coaxial catheter with a distal mixing tip, exposing alginate to a calcium chloride solution. In contrast to previously reported embolic agents, EmboGel can be selectively dissolved by EmboClear, a mixture of the enzyme alginate lyase and ethylenediaminetetraacetic acid (EDTA). The embolic and contrast properties of EmboGel were assessed in in vitro models of saccular aneurysm and an aortic aneurysm endoleak. The dissolvability of EmboGel with EmboClear was assessed further after endovascular delivery in the New Zealand white rabbit in the native aortoiliofemoral territory, a created saccular aneurysm, and the native carotid arteries. RESULTS: EmboGel effectively filled aneurysm cavities in the case of stent excluded saccular and fusiform aneurysms. EmboGel was readily dissolved by EmboClear in vitro and after in vivo embolization. When the distal abdominal aorta and pelvic arteries were occluded with EmboGel, within 1 minute of EmboClear infusion, patency of the aorta and most of the pelvic circulation was regained as noted by angiography. Embolization in the subclavian artery and numerous distal branches was rapidly dissolved by EmboClear. Finally, the carotid artery occluded with EmboGel regained patency after administration of EmboClear. CONCLUSIONS: EmboGel is a dissolvable alginate-based biomaterial that can be used for numerous embolic applications. EmboGel can be selectively dissolved with EmboClear, a solution of alginate lyase and EDTA.