Efficacy and safety of a magnesium stearate paclitaxel coated balloon catheter in the porcine coronary model

2021 ◽  
Author(s):  
Stephanie Bettink ◽  
Melanie Löchel ◽  
Daniel Peters ◽  
Wolfram Haider ◽  
Ulrich Speck ◽  
...  
Keyword(s):  
Balloon Catheter ◽  
Magnesium Stearate ◽  
Efficacy And Safety

scholarly journals Induction of labour in mid-trimester pregnancy using double-balloon catheter placement within 12 h versus within 12–24 h

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jing Peng ◽  
Ruobing Li ◽  
Shuguo Du ◽  
Heng Yin ◽  
Min Li ◽  
...  
Keyword(s):  
Retrospective Study ◽  
Balloon Catheter ◽  
Induction Of Labour ◽  
Cervical Ripening ◽  
Efficacy And Safety ◽  
Research Subjects ◽  
Cervical Dilation ◽  
Double Balloon ◽  
Trimester Pregnancy ◽  
Vaginal Deliveries

Abstract Background This study aims to evaluate the efficacy and safety of the induction of labour in mid-trimester pregnancy using a double-balloon catheter (DBC) within 12 h versus within 12–24 h. Methods In this retrospective study, a total of 58 pregnant women at 14 + 0 weeks to 27 + 6 weeks of gestation were enrolled as research subjects, and they underwent the intended termination of pregnancy at our birth centre from January 1, 2017, to June 31, 2019. Based on the duration of DBC, the patients were divided into two groups, namely, the DBC group within 12 h and the DBC group within 12–24 h. Results All 58 cases were successful vaginal deliveries, and no one chose to undergo caesarean section. The success rate of induction (successful abortion of the foetus and placenta without the implementation of dilation and evacuation) was higher in the DBC group within 12–24 h (96.3%, 29/31) than in the DBC group within 12 h (71.0%, 18/27) (p < 0.05). Additionally, the time from DBC removal to delivery in the DBC group within 12–24 h was significantly shorter than that in the DBC group within 12 h (3.0 h versus 17.8 h) (p < 0.05), and the degree of cervical dilation after DBC removal in the DBC group within 12–24 h was larger than that in the DBC group within 12 h (p < 0.05). Conclusion In the clinic, the placement time of DBC generally lasts for approximately 12 h. However, considering that the cervical condition is immature in the mid-trimester, properly extending the placement time of DBC to 24 h will benefit cervical ripening and reduce the chance of dilation and evacuation.

scholarly journals A132 ENDOSCOPIC ULTRASOUND-GUIDED GASTROENTEROSTOMY USING A NOVEL DOUBLE BALLOON DEVICE IN THE MANAGEMENT OF MALIGNANT GASTRIC OUTLET OBSTRUCTION

2021 ◽  
Vol 4 (Supplement_1) ◽  
pp. 115-117
Author(s):  
A Marino ◽  
A Bessissow ◽  
D Valenti ◽  
L Boucher ◽  
C Miller ◽  
...  
Keyword(s):  
Clinical Efficacy ◽  
Gastric Outlet Obstruction ◽  
Conscious Sedation ◽  
Clinical Success ◽  
Balloon Catheter ◽  
Outlet Obstruction ◽  
Efficacy And Safety ◽  
Malignant Gastric Outlet Obstruction ◽  
Double Balloon ◽  
Low Residue Diet

Abstract Background EUS-gastroenterostomy (EUS-GE) is a novel modality in the management of malignant gastric outlet obstruction (MGOO). It is, however, technically challenging limiting its widespread application. To facilitate EUS-GE, a double balloon catheter has been developed in Japan. While this tool is not available outside of Asia, we have conceived a similar device using a widely available vascular balloon catheter. We aim to determine the clinical efficacy and safety of EUS-GE using this double balloon device (DBD). Aims We aim to determine the clinical efficacy and safety of EUS-GE using this double balloon device (DBD). Methods This is a single-centre, retrospective study of consecutive patients who underwent DBD assisted EUS-GE for MGOO from January 2019-June 2020 (IRB approved). The DBD consists of two 60 mm vascular balloons (Coda, Cook Medical, USA) fashioned together with the balloons 10 cm apart (Figure 1). It is inserted across the obstruction over a wire to the ligaments of Treitz. Both balloons are then inflated followed by saline and contrast infusion into the occluded small bowel segment to facilitate EUS-guided insertion of a 15 mm cautery assisted lumen apposing metal stent (AxiosTM, Boston Scientific Inc, USA). The primary endpoint is the rate of technical success defined as adequate deployment of the stent. Secondary endpoints include rate of clinical success and adverse events. Results A total of 11 patients were included in this study. 45% were female with a mean age of 64.9 ± 8.6 years old. The etiology of MGOO was 73% pancreatic cancer, 9% gastric cancer, 9% duodenal cancer, and 9% metastatic cervical cancer. Procedures were performed under general anesthesia and conscious sedation in 82% and 18%, of patients respectively. The mean procedure time was 64.8 ± 25.8 minutes. Technical and clinical success (intention to treat) was 91%. The only technical failure was due to poor patient tolerance of the procedure under conscious sedation. There was one adverse event (9%) due to stent migration rated as severe. Two patients (18%) required re-intervention for stent obstruction secondary to food impaction associated with non-compliance to a low-residue diet. Following re-enforced instructions, no further obstruction occurred. All patients started a clear liquid diet within 1 day of the procedure with a mean time to a low residue diet of 3.25 days ± 2.5. The median length of hospital stay following the procedure was 5 days ± 13. The median follow-up time was 84 days (IQR 152). Conclusions DBD assisted EUS-GE is clinically effective and safe. This balloon device may greatly facilitate the technical aspect of EUS-GE while potential enhancing its safety and clinical use. Larger studies are needed to validate this approach to EUS-GE. Funding Agencies None

scholarly journals Efficacy and safety of prostaglandins vs double balloon catheter in inducing labor: a meta-analysis

2020 ◽  
Vol 9 (10) ◽  
pp. 4274
Author(s):  
Jia S. Chong ◽  
York L. Chew ◽  
Ayendra Fernando ◽  
Sivalingam Nalliah
Keyword(s):  
Cesarean Delivery ◽  
Vaginal Delivery ◽  
Fixed Effects ◽  
Balloon Catheter ◽  
Labour Induction ◽  
Cochrane Library ◽  
Efficacy And Safety ◽  
Double Balloon ◽  
Significant Difference ◽  
Uterine Hyperstimulation

Background: To compare the efficacy and safety of double‐balloon catheter with prostaglandin E2 (PGE2) in induction of labor.Methods: We searched electronic sources from Medline, Scopus, PubMed, Science Direct and Cochrane Library Database of Systematic Reviews. Only randomized controlled trials and observational studies comparing the PGE2 agents with double-balloon catheter for cervical ripening and labour induction in women with unfavorable cervix were included in the analysis. The main outcomes included vaginal delivery rate within 24 hours and cesarean delivery rates. We calculated relative risks and mean differences using fixed effects and random‐effects models.Results: Prostaglandin was more favourable for vaginal delivery within 24 hours compared to double balloon catheter, but was not statistically significant (RR 1.17: 95% CI 0.96-1.42 p =0.12). The induction to delivery time yielded a non-significant result that again favors prostaglandin (SMD 0.02 CI:0.18,0.22, p = 0.86). There was no significant difference in the cesarean delivery rates between the two groups (RR 1.02: 95% CI 0.92-1.14, p = 0.68). Uterine hyperstimulation and Neonatal Intensive Care Unit (NICU) admissions were significantly higher with prostaglandin. (RR 0.09: CI 0.04, 0.22 p<0.00001 and RR 0.75 CI: 0.62,0.90 p=003).Conclusions: There is no significant difference in the success of induction of labour between use of PGE2 and double balloon catheter. Uterine hyperstimulation and NICU admissions were significantly higher in Prostaglandin group.

scholarly journals Induction of labour in mid-trimester pregnancy using double-balloon catheter placement within 12 hours versus within 12-24 hours

2020 ◽  
Author(s):  
Jing Peng ◽  
Ruobing Li ◽  
Shuguo Du ◽  
Heng Yin ◽  
Min Li ◽  
...  
Keyword(s):  
Balloon Catheter ◽  
Induction Of Labour ◽  
Cervical Ripening ◽  
Efficacy And Safety ◽  
Cervical Dilation ◽  
Birth Center ◽  
Double Balloon ◽  
Trimester Pregnancy ◽  
Gestation Age ◽  
Research Objects

Abstract Background This study aims to evaluate the efficacy and safety of the induction of labour in mid-trimester pregnancy using double-balloon catheter (DBC) within 12 hours versus within 12–24 hours. Methods In this retrospective study, a total of 58 pregnant women with gestation age of 14 + 0 weeks to 27 + 6 weeks were enrolled as research objects, and they underwent intended termination of pregnancy at our birth center from January 1, 2017, to June 31, 2019. Based on the duration time of DBC, the cases were divided into two groups (DBC group within 12 hours and DBC group within 12–24 hours). Results All of the 58 cases were successful vaginal delivery and no one chose cesarean section. The success rate of induction (successful abortion of fetus and placenta without the implementation of dilatation and evacuation) was higher in the DBC group within 12–24 hours (96.3%, 29/31) than that in DBC group within 12 hours (71.0%, 18/27) (p < 0.05). At the same time, the time from DBC removal to delivery in 12–24 hours DBC group was significantly shorter than that in DBC group within 12 hours (3.0 h versus 17.8 h) (p < 0.05), the degree of cervical dilation after DBC removal in DBC group within 12–24 hours was larger than that in DBC group within 12 hours (p < 0.05). Conclusion In the clinic, the placement time of DBC is generally lasting for about 12 hours. However, considering the cervical condition is immature in the mid-trimester, properly extending the placement time of DBC to 24 hours will benefit for cervical ripening and lead to reduce chance of dilatation and evacuation.

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