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American Journal of Otolaryngology 2023Assess if a rigid, image-guided balloon could be used effectively and safely in revision sinus surgery.
PURPOSE
Assess if a rigid, image-guided balloon could be used effectively and safely in revision sinus surgery.
MATERIALS AND METHODS
A prospective, non-randomized, single-arm, multicenter study to assess the safety and device performance of the NuVent™ EM Balloon Sinus Dilation System. Adults with CRS in need of revision sinus surgery were enrolled for balloon sinus dilation of a frontal, sphenoid, or maxillary sinus. The primary device performance endpoint was the ability of the device to (1) navigate to; and (2) dilate tissue in subjects with scarred, granulated, or previously surgically-altered tissue (revision). Safety outcomes included the assessment of any operative adverse events (AEs) directly attributable to the device or for which direct cause could not be determined. A follow-up endoscopy was conducted at 14 days post-treatment for assessment of any AEs. Performance outcomes included the surgeon's ability to reach the target sinus (es) and dilate the ostia. Endoscopic photos were captured for each treated sinus pre- and post-dilation.
RESULTS
At 6 US clinical sites, 51 subjects were enrolled; 1 subject withdrew before treatment due to a cardiac complication from anesthesia. 121 sinuses were treated in 50 subjects. The device performed as expected in 100 % of the 121 treated sinuses, with investigators able to navigate to the treatment area and dilate the sinus ostium without difficulty. Ten AEs were seen in 9 subjects, with 0 related to the device.
CONCLUSION
The targeted frontal, maxillary or sphenoid sinus ostium were safely dilated in every revision subject treated, with no AEs directly attributed to the device.
Topics: Adult; Humans; Dilatation; Prospective Studies; Rhinitis; Maxillary Sinus; Catheterization; Endoscopy; Chronic Disease; Treatment Outcome
PubMed: 36889144
DOI: 10.1016/j.amjoto.2023.103803 -
Pediatric Surgery International Feb 2017Anastomotic strictures commonly occur in patients undergoing surgery for esophageal atresia (EA). The primary aim of this study was to determine the age distribution of... (Observational Study)
Observational Study
AIM OF THE STUDY
Anastomotic strictures commonly occur in patients undergoing surgery for esophageal atresia (EA). The primary aim of this study was to determine the age distribution of dilation procedures for anastomotic strictures over the patient's childhood after reconstruction of EA. The secondary aim was to evaluate the effect of postoperative proton pump inhibitors (PPIs) on the frequency of dilations.
METHODS
This observational study was conducted at a single tertiary center of pediatric surgery. The times that dilations of strictures were performed were assessed during three study periods: 1983-1995, 2001-2009, and 2010-2014. PPIs were not used during the first period, and then, respectively, for 3 and 12 months postoperatively. The indications for dilation were signs of obstruction and/or radiological signs of stricture.
PRIMARY RESULTS
A total of 131 children underwent esophageal reconstruction, and of those, 60 (46%) required at least 1 dilation procedure for strictures. There were no differences in the frequencies of dilation procedures between the three study periods (28/66, 18/32 and 14/33, respectively; P = 0.42). The overall median number of dilations per patient was 3 (range 1-21) with no differences between the study periods. The differences between ages at which the first dilation was performed during each study period were significant, as follows: 7, 2, and 8 months, respectively (P = 0.03). Fiftyone percent of all dilation procedures were performed during the first year of life, 16% during the second year, and 33% during years 2-15. Four children (2%) underwent >12 dilations.
CONCLUSION
The first year of life was the time of greatest need for dilation of AS after reconstruction of EA; however, dilations were also performed several years later. PPIs did not affect the frequency of dilations during the first year of life.
Topics: Adolescent; Age Distribution; Age Factors; Anastomosis, Surgical; Child; Child, Preschool; Constriction, Pathologic; Dilatation; Esophageal Atresia; Esophageal Stenosis; Female; Humans; Infant; Infant, Newborn; Male; Postoperative Complications; Proton Pump Inhibitors; Treatment Outcome
PubMed: 27844168
DOI: 10.1007/s00383-016-4013-z -
Surgical Endoscopy Dec 2023Corrosive substance ingestion in children represents a significant public health issue due to its long-term health sequelae. Esophageal stricture, main complication of...
OBJECTIVES
Corrosive substance ingestion in children represents a significant public health issue due to its long-term health sequelae. Esophageal stricture, main complication of this dangerous condition, is treated by pneumatic dilation and eventually by esophageal replacement. We aimed, through this study, to report the outcomes of esophageal pneumatic dilation complicating corrosive substance ingestion in children in a developing country.
METHODS
This cross-sectional study was performed on the population of pediatric patients with caustic esophageal stenosis between January 2005 and December 2020. All patients underwent pneumatic balloon dilation. A logistic regression model was built to predict the probability of the occurrence of the event (success/failure) of the dilation. The ROC curve is used to evaluate the performance of the logistic regression model to discriminate between positive and negative values of the dependent variable.
RESULTS
The success rate of pneumatic balloon dilation was 80.4%. The median duration of overall management was 11 months. The severity of caustic stricture observed during endoscopy was significantly linked to worse outcomes (p = 0.001). Multivariate analysis indicated that the severity of stenosis and the number of dilation sessions were independent risk factors for failure of dilation. ROC curve analysis showed that the area under the curve was 71.7%. A Cut-Off point value of 7 provided the best sensitivity and specificity.
CONCLUSION
Pneumatic balloon dilation has been proven to be efficacious in infants with caustic esophageal stricture. Pediatric surgeons should take into account factors to promptly switch to replacement surgery and avoid unnecessary and time-consuming serial dilations.
Topics: Infant; Child; Humans; Esophageal Stenosis; Caustics; Dilatation; Cross-Sectional Studies; Developing Countries; Retrospective Studies; Treatment Outcome; Constriction, Pathologic; Risk Factors
PubMed: 37884732
DOI: 10.1007/s00464-023-10489-w -
Alimentary Pharmacology & Therapeutics Nov 2015Endoscopic balloon dilatation (EBD) is recognised treatment for symptomatic Crohn's strictures. Several case series report its efficacy. A systematic analysis for... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Endoscopic balloon dilatation (EBD) is recognised treatment for symptomatic Crohn's strictures. Several case series report its efficacy. A systematic analysis for overall efficacy can inform the design of future studies.
AIM
To examine symptomatic (SR) and technical response (TR) and adverse events (AE) of EBD. Stricture characteristics were also explored.
METHODS
A systematic search strategy of COCHRANE, MEDLINE and EMBASE was performed. All original studies reporting outcomes of EBD for Crohn's strictures were included. SR was defined as obstructive symptom-free outcome at the end of follow-up, TR as post-dilatation passage of the endoscope through a stricture, and adverse event as the presence of complication (perforation and/or bleeding). Pooled event rates across studies were expressed with summative statistics.
RESULTS
Twenty-five studies included 1089 patients and 2664 dilatations. Pooled event rates for SR, TR, complications and perforations were 70.2% (95% CI: 60-78.8%), 90.6% (95% CI: 87.8-92.8%), 6.4% (95% CI: 5.0-8.2) and 3% (95% CI: 2.2-4.0%) respectively. Cumulative surgery rate at 5 year follow-up was 75%. Pooled unweighted TR, SR, complication, perforation and surgery rates were 84%, 45%, 15%, 9% and 21% for de novo and 84%, 58%, 22%, 5% and 32% for anastomotic strictures. Outcomes between two stricture types were no different on subgroup meta-analysis.
CONCLUSIONS
Efficacy and complication rates for endoscopic balloon dilatation were higher than previously reported. From the few studies with 5 year follow-up the majority required surgery. Future studies are needed to determine whether endoscopic balloon dilatation has significant long-term benefits.
Topics: Constriction, Pathologic; Crohn Disease; Dilatation; Endoscopy; Humans; Treatment Outcome
PubMed: 26358739
DOI: 10.1111/apt.13388 -
Expert Review of Medical Devices Jan 2015The Vent-Os Sinus Dilation System is an osmotically driven device that provides a means to access the sinus space and to dilate the maxillary sinus ostia and associated... (Review)
Review
The Vent-Os Sinus Dilation System is an osmotically driven device that provides a means to access the sinus space and to dilate the maxillary sinus ostia and associated spaces in adults for diagnostic and therapeutic procedures. Unlike balloon dilation devices that use rapid, high-pressure inflation, this self-expanding device is designed to gently and gradually open the maxillary ostia. The procedure can be safely and easily completed in-office with minimal anesthetics and analgesics on board. Clinical results support excellent patency and safety outcomes with the use of this product in patients with chronic rhinosinusitis.
Topics: Adult; Chronic Disease; Dilatation; Female; Humans; Male; Nasal Surgical Procedures; Osmosis; Rhinitis; Sinusitis
PubMed: 25467029
DOI: 10.1586/17434440.2015.975116 -
Diabetes/metabolism Research and Reviews Feb 2023Gestational diabetes mellitus (GDM) is a common medical complication during pregnancy. Endothelial dysfunction is considered an early step in the progression of... (Meta-Analysis)
Meta-Analysis
AIMS
Gestational diabetes mellitus (GDM) is a common medical complication during pregnancy. Endothelial dysfunction is considered an early step in the progression of atherosclerosis that may contribute to subclinical target organ damage. This meta-analysis aimed to systemically review the existing data regarding endothelial dysfunction between women with and without GDM during pregnancy and post-partum using flow-mediated dilation (FMD).
MATERIALS AND METHODS
Eligible studies (cohort and observational) published until October 2021 were identified in the MEDLINE, Scopus, Cochrane Library database and grey literature sources were searched.
RESULTS
The search yielded 2272 studies, of which 17 were fully reviewed and 12 studies (N = 740 pregnant women) were finally included. Pregnant women with GDM exhibited a significantly lower FMD compared to pregnant women without GDM (pooled mean difference -3.12; 95% CI -5.36 to -0.88). Moreover, in the immediate (1-6 months) post-partum period, women with previous GDM showed lower FMD compared to healthy women without GDM history (pooled mean difference -7.52; 95% CI -9.44 to -5.59), whereas FMD did not differ in the late post-partum period (more than 4 years).
CONCLUSIONS
Flow-mediated dilation is decreased in women with GDM during pregnancy and in the immediate post-partum period, compared to women without GDM, indicating that the endothelial dysfunction noted during the pregnancy in those women persists in the immediate post-partum period too.
CLINICAL TRIAL REGISTRATION
PROSPERO CRD42021283113 (www.
CLINICALTRIALS
gov).
Topics: Pregnancy; Female; Humans; Diabetes, Gestational; Dilatation; Postpartum Period; Vascular Diseases
PubMed: 36507606
DOI: 10.1002/dmrr.3600 -
Otolaryngology--head and Neck Surgery :... Nov 2020Identify the effects of balloon dilation duration and topical ciprofloxacin-dexamethasone application in treatment of subglottic stenosis.
OBJECTIVES
Identify the effects of balloon dilation duration and topical ciprofloxacin-dexamethasone application in treatment of subglottic stenosis.
STUDY DESIGN
Randomized controlled trial.
SETTING
Animal research facility.
SUBJECTS AND METHODS
Forty-four rabbits underwent subglottic injury in an Institutional Animal Care and Use Committee-approved study. One week after injury, the subglottis of each rabbit was measured and treated with endoscopic balloon dilation for 2 rounds of short duration (SBD; 3 seconds), long duration (LBD; 30 seconds), or LBD with topical ciprofloxacin-dexamethasone application (LBD+C). The subglottis of each rabbit was remeasured at the study endpoint: 1 month postdilation or following development of life-threatening respiratory distress.
RESULTS
Of 44 rabbits, 35 (80%) survived to endoscopic balloon dilation, with 21 rabbits developing a grade III Cotton-Myer stenosis. Prior to dilation, there was no difference in stenosis rates among groups (all subjects, = .99; grade III stenosis only, = .52). Among grade III subjects, improvement in stenosis after dilation was -1% (SD, 21%) for SBD, 27% (SD, 38%) for LBD, and 58% (SD, 29%) for LBD+C ( = .01). Early euthanasia/death rates among grade III subjects were 85% for SBD, 63% for LBD, and 17% for LBD+C ( = .03). Time to early euthanasia/death was 5.0 days for the SBD group and 8.4 days for the LBD group ( = .04).
CONCLUSION
SBD was inferior to LBD or LBD+C in multiple metrics. LBD+C offered significant improvements in stenosis size and mortality over the SBD group and had the lowest rate of early mortality. Further research is needed to identify optimal balloon dilation treatment duration.
Topics: Administration, Topical; Animals; Anti-Bacterial Agents; Anti-Inflammatory Agents; Ciprofloxacin; Combined Modality Therapy; Dexamethasone; Dilatation; Disease Models, Animal; Drug Combinations; Female; Laryngoscopy; Laryngostenosis; Rabbits; Random Allocation
PubMed: 32571137
DOI: 10.1177/0194599820931486 -
Saudi Journal of Gastroenterology :... 2016In recent years, endoscopic papillary large balloon dilation (EPLBD) with endoscopic sphincterotomy (EST) has been shown to be an effective technique for the removal of... (Review)
Review
In recent years, endoscopic papillary large balloon dilation (EPLBD) with endoscopic sphincterotomy (EST) has been shown to be an effective technique for the removal of large or difficult common bile duct (CBD) stones, as an alternative to EST. Reviewing the literature published since 2003, it is understood that EPLBD has fewer associated overall complications than EST. Bleeding occurred less frequently with EPLBD than with EST. There was no significant difference in postendoscopic retrograde cholangiopancreatography pancreatitis or perforation. Recent accumulated results of EPLBD with or even without EST suggest that it is a safe and effective procedure for the removal of large or difficult bile duct stones without any additional risk of severe adverse events, when performed under appropriate guidelines. Since use of a larger balloon can tear the sphincter as well as the bile duct, possibly resulting in bleeding and perforation, a balloon size that is equal to or smaller in diameter than the diameter of the native distal bile duct is recommended. The maximum transverse diameter of the stone and the balloon-stone diameter ratio have a tendency to affect the success or failure of complete removal of stones by large balloon dilation to prevent adverse effects such as perforation and bleeding. One should take into account the size of the native bile duct, the size and burden of stones, the presence of stricture of distal bile duct, and the presence of the papilla in or adjacent to a diverticulum. Even though the results of EPLBD indicate that it is a relatively safe procedure in patients with common duct stones with a dilated CBD, the recommended guidelines should be followed strictly for the prevention of major adverse events such as bleeding and perforation.
Topics: Cholangiopancreatography, Endoscopic Retrograde; Choledocholithiasis; Dilatation; Humans; Randomized Controlled Trials as Topic; Sphincterotomy, Endoscopic; Treatment Outcome
PubMed: 27488319
DOI: 10.4103/1319-3767.187599 -
Ophthalmology Mar 2023We evaluated the noninferiority of 10.4 μl of eye drops eluted with a commercially available eye drop adapter, the Nanodropper (Nanodropper, Inc), on pupillary dilation... (Randomized Controlled Trial)
Randomized Controlled Trial
PURPOSE
We evaluated the noninferiority of 10.4 μl of eye drops eluted with a commercially available eye drop adapter, the Nanodropper (Nanodropper, Inc), on pupillary dilation and cycloplegia in children compared with the standard of care (SOC), 50 μl of eye drops.
DESIGN
Prospective randomized trial.
PARTICIPANTS
Pediatric patients scheduled for routine pupillary dilation at the University of California, San Francisco, at the Pediatric Ophthalmology Clinic were enrolled. Each participant provided 1 eye for the intervention group (Nanodropper) and 1 eye for the control group (SOC).
METHODS
Participants were randomized to receive small-volume dilating drops in 1 eye (Nanodropper) and SOC dilating drops in the other eye. Dilation was performed using 1 drop each of 1% cyclopentolate, 1% tropicamide, and 2.5% phenylephrine. Refraction and pupillometry were obtained before and 30 minutes after dilation. A noninferiority analysis was performed to assess change from before to after dilation in spherical equivalent and in pupil constriction percentage and maximum pupil diameter after dilation.
MAIN OUTCOME MEASURES
Spherical equivalent, maximum pupil diameter, and pupil constriction percentage.
RESULTS
One hundred eyes of 50 patients were included, with a mean ± standard deviation age of 9 ± 3 years. After controlling for baseline measurements, the spherical equivalent after dilation was 0.05 diopter (D) more (95% confidence interval [CI], -0.28 to 0.37 D) in the Nanodropper arm, which did not achieve noninferiority. Maximum pupil diameter after dilation was lower in the Nanodropper group (mean, -0.01 mm; 95% CI, -0.20 to -0.03), which did achieve noninferiority. Constriction percentage after dilation was 0.57 percentage points more (95% CI, -1.38 to 2.51 percentage points) in the Nanodropper group, which did not achieve noninferiority.
CONCLUSIONS
Administration of eye drops using a small-volume adapter demonstrated similar efficacy to SOC in a pediatric population. Strict noninferiority was met only for pupillary dilation and not for cycloplegia or constriction percentage; however, the small differences in the effect of the Nanodropper versus SOC on all primary outcomes were not clinically significant. We conclude that small-volume eye drops have the potential to decrease unnecessary medical waste and medication toxicity while maintaining therapeutic effect.
FINANCIAL DISCLOSURE(S)
Proprietary or commercial disclosure may be found after the references.
Topics: Humans; Child; Mydriatics; Prospective Studies; Dilatation; Pupil; Tropicamide; Phenylephrine; Presbyopia; Ophthalmic Solutions
PubMed: 36280185
DOI: 10.1016/j.ophtha.2022.10.016 -
Medical Science Monitor : International... Jun 2023Cervical ripening is defined as the significant softening of the cervical tissue that usually begins before the onset of contractions during labor, and is required for... (Review)
Review
Cervical ripening is defined as the significant softening of the cervical tissue that usually begins before the onset of contractions during labor, and is required for cervical dilation and delivery. Osmotic dilators are medical implements that dilate the uterine cervix by increasing in size as they absorb fluid from the surrounding tissue. This article aims to review the mechanisms and applications of osmotic dilators for cervical ripening in the induction of labor and in gynecology procedures.
Topics: Pregnancy; Female; Humans; Cervical Ripening; Gynecology; Abortion, Induced; Labor, Induced; Dilatation
PubMed: 37368878
DOI: 10.12659/MSM.940127