Methods for the induction of labor: efficacy and safety.

This review assessed the efficacy and safety of pharmacologic agents (prostaglandins, oxytocin, mifepristone, hyaluronidase, and nitric oxide donors) and mechanical methods (single- and double-balloon catheters, laminaria, membrane stripping, and amniotomy) and those generally considered under the rubric of complementary medicine (castor oil, nipple stimulation, sexual intercourse, herbal medicine, and acupuncture). A substantial body of published reports, including 2 large network meta-analyses, support the safety and efficacy of misoprostol (PGE1) when used for cervical ripening and labor induction. Misoprostol administered vaginally at doses of 50 µg has the highest probability of achieving vaginal delivery within 24 hours. Regardless of dosing, route, and schedule of administration, when used for cervical ripening and labor induction, prostaglandin E2 seems to have similar efficacy in decreasing cesarean delivery rates. Globally, although oxytocin represents the most widely used pharmacologic agent for labor induction, its effectiveness is highly dependent on parity and cervical status. Oxytocin is more effective than expectant management in inducing labor, and the efficacy of oxytocin is enhanced when combined with amniotomy. However, prostaglandins administered vaginally or intracervically are more effective in inducing labor than oxytocin. A single 200-mg oral tablet of mifepristone seems to represent the lowest effective dose for cervical ripening. The bulk of the literature assessing relaxin suggests this agent has limited benefit when used for this indication. Although intracervical injection of hyaluronidase may cause cervical ripening, the need for intracervical administration has limited the use of this agent. Concerning the vaginal administration of nitric oxide donors, including isosorbide mononitrate, isosorbide, nitroglycerin, and sodium nitroprusside, the higher incidence of side effects with these agents has limited their use. A synthetic hygroscopic cervical dilator has been found to be effective for preinduction cervical ripening. Although a pharmacologic agent may be administered after the use of the synthetic hygroscopic dilator, in an attempt to reduce the interval to vaginal delivery, concomitant use of mechanical and pharmacologic methods is being explored. Combining the use of a single-balloon catheter with dinoprostone, misoprostol, or oxytocin enhances the efficacy of these pharmacologic agents in cervical ripening and labor induction. The efficacy of single- and double-balloon catheters in cervical ripening and labor induction seems similar. To date, the combination of misoprostol with an intracervical catheter seems to be the best approach when balancing delivery times with safety. Although complementary methods are occasionally used by patients, given the lack of data documenting their efficacy and safety, these methods are rarely used in hospital settings.

Comparison of Outcomes between a Basket Catheter and a Balloon Catheter for Endoscopic Common Bile Duct Stone Removal.

INTRODUCTION: Evidence for the outcomes of endoscopic retrograde cholangiopancreatography (ERCP) between a basket catheter and a balloon catheter for endoscopic common bile duct stone (CBDS) removal is lacking. This study aimed to compare ERCP outcomes using a basket catheter and a balloon catheter for endoscopic CBDS removal. METHODS: This multicenter retrospective study included 904 consecutive patients with native papilla who underwent endoscopic stone removal for CBDS ≤10 mm using a basket catheter and/or a balloon catheter at three institutions in Japan. ERCP outcomes between the basket and balloon groups were compared using inverse probability of treatment weighting (IPTW) method. RESULTS: ERCP-related adverse events occurred in 6.5% (29/449) and 7.7% (35/455) of patients in the basket and balloon groups, respectively (IPTW-adjusted p = 0.52). The incidences of post-ERCP pancreatitis, cholangitis, and perforation were similar in the basket and balloon groups (3.8% vs. 2.9%, 1.3% vs. 0.9%, and 0.7% vs. 0.7%, respectively). However, bleeding incidences were significantly higher in the balloon group than in the basket group (3.3% vs. 0.7%, IPTW-adjusted p = 0.012). Successful complete stone removal at one ERCP session using a single catheter was achieved in 17.8% (80/449) in the basket group and in 81.3% (370/455) in the balloon group (IPTW-adjusted p < 0.001). DISCUSSION: A balloon catheter is more likely to complete stone extraction for CBDS ≤10 mm with a single catheter at one endoscopic stone removal session. However, the risk for post-ERCP bleeding is higher in the balloon group than in the basket group.

Development of a patient-specific model of the human coronary system for percutaneous transluminal coronary angioplasty balloon catheter training and testing.

BACKGROUND: To treat stenosed coronary arteries, percutaneous transluminal coronary angioplasty (PTCA) balloon catheters must combine pushability, trackability, crossability, and rewrap behavior. The existing anatomic track model (ASTM F2394) for catheter testing lacks 3D morphology, vessel tortuosity, and compliance, making evaluating performance characteristics difficult. This study aimed to develop a three-dimensional patient-specific phantom (3DPSP) for device testing and safe training for interventional cardiologists. METHODS: A range of silicone materials with different shore hardnesses (00-30-45 A) and wall thicknesses (0.5 mm, 1 mm, 2 mm) were tested to determine compliance for creating coronary vessel phantoms. Compliance was assessed using optical coherence tomography (OCT) and compared to values in the literature. Stenosis was induced using multilayer casting and brushing methods, with gypsum added for calcification. The radial tensile properties of the samples were investigated, and the relationship between Young's modulus and compliance was determined. Various methods have been introduced to approximate the friction between silicone and real coronary vessel walls. Computerized tomography (CT) scans were used to obtain patient-specific anatomy from the femoral artery to the coronary arteries. Artery lumens were segmented from the CT scans to create dissolvable 3D-printed core models. RESULTS: A 15A shore hardness silicone yielded an experimental compliance of 12.3-22.4 m m 2 mmHg · 10 3 for stenosed tubes and 14.7-57.9 m m 2 mmHg · 10 3 for uniform tubes, aligning closely with the literature data (6.28-40.88 m m 2 mmHg · 10 3 ). The Young's modulus ranged from 43.2 to 75.5 kPa and 56.6-67.9 kPa for the uniform and calcified materials, respectively. The dependency of the compliance on the wall thickness, Young's modulus, and inner diameter could be shown. Introducing a lubricant reduced the silicone friction coefficient from 0.52 to 0.13. The 3DPSP was successfully fabricated, and comparative analyses were conducted among eight commercially available catheters. CONCLUSION: This study presents a novel method for crafting 3DPSPs with realistic mechanical and frictional properties. The proposed approach enables the creation of comprehensive and anatomically precise setups spanning the right femoral artery to the coronary arteries, highlighting the importance of such realistic environments for advancing medical device development and fostering safe training conditions.

Resuscitative endovascular balloon occlusion of the aorta (REBOA) as adjunct treatment in life threatening postpartum hemorrhage: Fourteen years' experience from a single Norwegian center.

INTRODUCTION: Postpartum hemorrhage (PPH) remains a global health problem. The introduction of resuscitative endovascular balloon occlusion of the aorta (REBOA) in 2008 sought to enhance the management of hemorrhagic shock during PPH. In this study, we present a single Norwegian center's experience with REBOA as a supportive treatment in combating life threatening PPH. MATERIAL AND METHODS: This is a historical cohort study from St Olav's University Hospital, with data from period 2008-2021. It includes all patients who underwent REBOA as an adjunct treatment due to life threatening PPH, analyzing the outcomes and trends over a 14-year period. RESULTS: A total of 37 patients received REBOA as an adjunct treatment. All procedures were technically successful, achieving hemodynamic stability with an immediate average increase in systolic blood pressure of 36 ± 22 mmHg upon initial balloon inflation. Additionally, a downward trend was noted in the frequency of hysterectomies and the volume of blood transfusions required over time. No thromboembolic complications were observed. CONCLUSIONS: Our 14 years of experience at St Olav's Hospital suggests that REBOA serves as a safe and effective adjunct interventional technique for managing life-threatening PPH. Furthermore, the findings indicate that incorporating a multidisciplinary approach to enable rapid aortic occlusion can potentially reduce the necessity for blood transfusions and hysterectomies.

Balloon Dilatation for Bronchoscope Delivery in a Swine Model: A Novel Technique for Ultra-Peripheral Lung Field Access and Accurate Biopsy.

INTRODUCTION: In transbronchial biopsy of peripheral pulmonary lesions, the bronchoscope can reach only a limited depth due to the progressive narrowing of bronchi, which may reduce the diagnostic rate. This study examined the balloon dilatation for bronchoscope delivery (BDBD) technique, employing a novel balloon device to enhance bronchoscopy into the peripheral lung areas. METHODS: Anaesthetised swine served as our primary model. Using computed tomography (CT) scans, we positioned virtual targets characterised by a positive bronchus sign and a diameter of 20 mm beneath the pleura. The bronchoscope was navigated along the pathways determined from the CT images. We performed balloon dilatation when bronchial narrowing obstructed progress to assess whether balloon dilatation would enable the bronchoscope to enter further into the periphery. RESULTS: We established 21 virtual targets on the CT scans. An average of 12.1 branches were identified along the pathways on the CT scans; however, bronchoscopy without BDBD only allowed access to an average of 6.7 branches. Based on 72 balloon dilatations with 3.0-mm or 4.0-mm ultra-thin bronchoscopes, there was an average increased access of 3.43 and 5.14 branches per route, respectively, with no significant BDBD complications. The bronchoscope was able to reach the planned location along all pathways, and the mean final bronchoscopic endpoints were at an average distance of 14.7 mm from the pleura. Post-procedure CT confirmed biopsy accuracy. CONCLUSION: The BDBD technique can enhance access of a flexible bronchoscope into the peripheral lung fields, which could potentially allow more accurate transbronchial interventions for peripheral targets.

Self-Traction During Mechanical Cervical Dilatation, Acceptability, Feasibility and Satisfaction of its Application: A Pilot Study.

This study aims to measure acceptability, feasibility, and satisfaction with self-traction during mechanical cervical dilatation to induce labour and to explore its effects on pain and the process of labour and delivery. 60 parturients were randomly assigned to self-traction or regular traction. Participants completed questionnaires about sociodemographic characteristics, acceptability, and satisfaction. Self-traction participants reported significantly higher acceptability (P = 0.026), and adequacy (P = 0.018). They also reported satisfaction with the procedure. A group comparison regarding feasibility, pain, and the process of labour and delivery showed no significant difference. Self-traction is an acceptable and feasible intervention for full-term parturients.

Preinduction cervical ripening in an outpatient setting: a prospective pilot study of a synthetic osmotic dilator compared with a double-balloon catheter.

OBJECTIVES: To compare the effectiveness, safety and patient satisfaction of a double balloon catheter (DB) with a synthetic osmotic cervical dilator (OD) for pre-induction cervical ripening in an outpatient setting. METHODS: This is a prospective, dual-center pilot study including 94 patients with an unripe cervix (Bishop Score <6) near term; 50 patients received the DB and 44 patients the OD. The primary outcomes were the difference in Bishop Score (BS) and cervical shortening. Pain perception at insertion and during the cervical ripening period was evaluated by a visual analogue scale and patient satisfaction by a predefined questionnaire. RESULTS: The use of DB was associated with a significantly higher increase in BS (median 3) compared to OD (median 2; p=0.002) and resulted in significantly greater cervical shortening (median -14 mm vs. -9 mm; p=0.003). There were no serious adverse events at placement of devices or during the cervical ripening. There were no significant differences in perinatal outcomes. Pain perception during cervical ripening was significantly higher (p<0.001), and patient satisfaction regarding sleep, relaxing time and performing desired daily activities were significantly lower in patients with DB compared to patients with OD (p<0.001). CONCLUSIONS: DB was superior to OD regarding cervical ripening based on BS and on sonographic measurement of the cervical length. Patients with OD experienced less pain during cervical ripening and were more satisfied with the method compared to patients with DB.

Efficacy and safety of double balloon catheter and dinoprostone for labor induction in multipara at term.

PURPOSE: The aim of this study was to comparatively assess the efficacy and safety of double balloon catheter (DBC) and dinoprostone as labor-inducing agents just for multipara at term. METHODS: A retrospective cohort study was conducted among multipara at term with a Bishop score < 6 who needed planned labor induction from January 1, 2020, to December 30, 2020 in Maternal and Child Health Hospital of Hubei province, Tongji Medical College, Huazhong University of Science and Technology. They were divided into DBC group and dinoprostone group, respectively. Baseline maternal data, maternal and neonatal outcomes were recorded for statistical analysis. Total vaginal delivery rate, rate of vaginal delivery within 24 h, rate of uterine hyperstimulation combined with abnormal fetal heart rate(FHR) were regarded as the primary outcome variables. The difference between groups was considered statistically significant when p value < 0.05. RESULTS: A total of 202 multiparas was included for analysis (95 women in DBC group vs 107 women in dinoprostone group). There were no significant differences in total vaginal delivery rate and rate of vaginal delivery within 24 h between groups. Uterine hyperstimulation combined with abnormal FHR occurred exclusively in dinoprostone group. CONCLUSION: DBC and dinoprostone seem to be equally effective, while, DBC seems to be safer than dinoprostone.

The infection, cervical and perineal lacerations in relation to postpartum hemorrhage following vaginal delivery induced by Cook balloon catheter.

OBJECTIVE: To identify whether infection, cervical laceration and perineal laceration are associated with postpartum hemorrhage in the setting of vaginal delivery induced by Cook balloon catheter. MATERIALS AND METHODS: The retrospective study included 362 women who gave birth vaginally at or beyond 37 weeks of gestation with a diagnosis of postpartum hemorrhage between February 2021 to May 2022, of which including 216 women with induction of labor (Cook balloon catheter followed by oxytocin or oxytocin) and 146 women with spontaneous delivery. Risk factors for postpartum hemorrhage were collected and compared. RESULTS: 362 women were divided into three groups, group 1 with spontaneous delivery, group 2 with oxytocin, group 3 with Cook balloon catheter followed by oxytocin. There was no significant difference in incidence of infection within three groups (P > 0.05). The rate of cervical laceration and perineal laceration was significantly higher in group 3 compared with groups 2 and 1 (P < 0.05); Multivariate logistic regression analysis found that compared with group 1, either group 3 or group 2 was associated with increased risks of cervical laceration and perineal laceration (P < 0.05), and compared with group 2, group 3 was not associated with increased risks of cervical laceration and perineal laceration (P > 0.05). CONCLUSION: Infection, cervical laceration and perineal laceration are identified not to be independent risk factors for postpartum hemorrhage for women undergoing labor with Cook balloon catheter; Cervical laceration and perineal laceration increase the risk of postpartum hemorrhage in women with labor induction.

Effect of balloon dilatation among adult population with eustachian tube dysfunction: a systematic review.

PURPOSE: This study aimed to assess the efficacy and safety of ballon dilation of the eustachian tube (BDET) in adult population suffering from Eustachian tube dysfunction (ETD). METHODS: Following PRISMA criteria, a systematic review was conducted by searching PubMed, Cochrane, and Embase databases from January 2015 to March 2024. The primary outcomes included Eustachian Tube Score (ETS), tympanometry, and Valsalva maneuver. The quality of studies was assessed using the Quality in Prognostic Studies (QUIPS) instrument. RESULTS: Overall, 11 studies were incorporated into the systematic review: two RCTs, three prospective investigations, and six retrospective studies. The balloon dilation in all investigations was performed using either Spiggle & Theis or Acclarent catheters for balloon dilation. There was heterogeneity across studies examining the effect of BDET on persistent ETD in terms of patient selection, period of follow-up, administration of conservative or surgical therapies, and use of assessment methods. Overall, the treatment yielded alleviation of symptoms, which either exhibited stability over time or demonstrated further improvement after an average duration of follow-up. Moreover, the incidence of complications was categorized as low and resolving spontaneously. The majority of the studies exhibited a high risk of bias related to confounding variables, and consequently, the overall risk of bias across most studies was considered high. CONCLUSION: The findings suggest BDET holds promise for ETD treatment, reducing symptom severity with minimal complications. Nonetheless, there is a need for improved studies that adhere to established indications, methodologies, and outcomes to establish a more robust body of evidence.

Temporary Ureter Occlusion with Simultaneous Urinary Diversion via a Single-Access Route Using a 4-French Balloon Catheter and a Pigtail Nephrostomy Drainage Catheter.

Background and Objectives: This study evaluated the efficacy and safety of temporary ureteral occlusion combined with urinary diversion using a single-access route created by inserting a balloon catheter through a pigtail nephrostomy drainage catheter. With this approach, we aimed to offer an alternative for patients with ureteral leaks who are suboptimal surgical candidates. Materials and Methods: This retrospective study included nine patients (eight of which were bilateral cases and one was unilateral, totaling seventeen cases) who underwent the surgery between September 2023 and March 2024. The method involved gaining percutaneous access to the pelvicalyceal system, inserting a 4-French Fogarty balloon catheter through a pigtail nephrostomy catheter, and inflating the balloon at the proximal or mid-ureter. Results: All 17 cases achieved technical successful with no major complications. The procedure effectively relieved symptoms associated with urinary leakage in most patients. However, the significant deflation of the balloon catheter occurred in five cases (29.4%), with three (17.6%) experiencing complete deflation. In these five cases, the final balloon size was 5.81 mm (range: 0-8.9 mm), confirming a 25.0% decrease in size from pre- to post-procedure. Ureteral occlusion was 28.3 d long on average (range: 8-57 d). All patients experienced symptom relief during temporary ureteral occlusion. Except for two patients lost to follow-up, three patients showed symptom improvement with only PCN and four patients underwent surgical closure of the fistula tract before or after balloon catheter removal. Conclusions: This study confirms that this approach is safe and effective.

Design of percutaneous transluminal coronary angioplasty balloon catheters.

BACKGROUND: Eight commercially available percutaneous transluminal coronary angioplasty (PTCA), including semi-compliant and non-compliant balloons, have been assessed in detail on their tip, balloon, shaft, RX-Port, and hypotube design. Important performance characteristics such as tip deformation, balloon elongation, and deflation rate have been quantified. METHODS: Five catheters of each model were evaluated during various tests. The robustness of the tips was evaluated through compression, measuring any occurrence of damage. The longitudinal growth of the balloons was recorded during inflation up to Rated Burst Pressure (RBP). The forces required to move the catheter forward and retract it into the guide catheter were measured in a simulated use test setup. The deflation behavior was studied by measuring extracted contrast media over time. Furthermore, balloon compliance and catheter dimensions were investigated. RESULTS: The outer dimensions of the catheter were found to be smallest at the hypotube (0.59-0.69 mm) and highest at the balloon, respectively, the crossing profile (0.9-1.2 mm). The tip diameter increased after compression by 1.7-22%. Cross-sections of the folded balloons revealed a tri- and two-fold, respectively. The measured balloon elongation ranged from 0.6 to 2.0 mm. After the inflation of the balloon, an increase in friction between the guide wire and the catheter was observed on four catheters. A maximum increase of 0.12 N to 1.07 N was found. Cross-sections of the RX-Port revealed a semicircular-shaped inflation lumen and a circular guide wire lumen. The measured deflation rate ranged from 0.004 to 0.013 µL/s, resulting in an estimated balloon deflation time of 10.2-28.1 s. CONCLUSION: This study provides valuable insights into the design characteristics of RX PTCA balloon catheters, which can contribute to facilitating the development of improved catheter designs and enhancing clinical outcomes. Distinctions between SC and NC catheters, such as balloon performance and dimensions, are evident. It is important to note that no single catheter excels in all aspects, as each possesses unique strengths. Therefore, it is essential to consider individual intervention requirements when selecting a catheter. The research also identifies specific catheter weaknesses, such as reduced wall thickness, fringes at the tip, and reduced performance characteristics.

Laparoscopic antireflux surgery or PPIs in the management of reflux-related esophageal stricture.

BACKGROUND: Gastroesophageal reflux disease (GERD) is often associated with esophageal stricture, particularly benign esophageal stricture. We aimed to evaluate the effects of balloon catheter dilation (BD) combined with laparoscopic fundoplication (LF) surgery and proton pump inhibitors (PPIs) in patients with reflux-induced esophageal strictures. METHODS: We retrospectively analyzed 116 patients with reflux-induced benign esophageal strictures who underwent balloon dilatation therapy combined with PPIs (BD-PPIs group, n = 58) and balloon dilatation combined with LF (BD-LF group, n = 58). Patients were followed up for 24 months. The outcomes of the patients were monitored, including clinical success, symptom improvement, adverse events, and the frequency of esophagitis. RESULTS: At the latest follow-up, the rate of clinical success was higher in BD-LF group than in BD-PPIs group (80.4% vs. 57.7%, P = 0.011). The patients in the BD-PPIs group required more dilation sessions to achieve successful dilation, as compared to those in the BD-LF group (2.1 ± 1.2 vs. 0.7 ± 0.8, P < 0.001). The DeMeester score, number of reflux episodes for which pH was < 4, and lower esophageal sphincter pressure were significantly better in the BD-LF group than in the BD-PPIs group (all P < 0.001). The incidence of reflux esophagitis was higher in the BD-PPIs group than in the BD-LF group, at 24 months (58.8% vs. 18.2%, P = 0.003). CONCLUSIONS: Balloon dilatation with concomitant LF is effective and safe for esophageal stricture secondary to GERD. Moreover, antireflux surgery techniques, such as Nissen or Toupet procedure, should be added for reflux-induced benign esophageal stricture.

Predictors of vaginal delivery following balloon catheter for labor induction in women with one previous cesarean.

BACKGROUND: The aim of this study was to estimate predictors for vaginal birth following balloon catheter induction of labor (IOL) in women with one previous cesarean section (CS) and an unfavorable cervix. METHODS: This 4-year retrospective cohort study was conducted in Longhua District Central Hospital in Shenzhen China, between January 2015 and December 2018. Patients with one previous CS and a current singleton-term pregnancy who underwent balloon catheter cervical ripening and IOL were enrolled. Univariate analysis was used to identify predictive factors associated with vaginal birth after cesarean section (VBAC). Binary logistic regression was further used to identify which factors were independently associated with the outcome measure. The primary outcome was VBAC, which was a successful trial of labor after cesarean delivery (TOLAC) following IOL. RESULTS: A total of 69.57% (208/299) of the women who planned for IOL had VBAC. In the final binary logistic regression equation, lower fetal weight (< 4000 g) (odds ratio [OR]5.26; 95% confidence interval [CI] 2.09,13.27), lower body mass index (BMI,<30 kg/m2) (OR 2.27; CI 1.21, 4.26), Bishop score after cervical ripening > 6 (OR 1.94; CI 1.37, 2.76) remained independently associated with an increased chance of VBAC. CONCLUSIONS: The influencing factors of VBAC following IOL were fetal weight, BMI, and Bishop score after cervical ripening. Adequate individualized management and assessment of the IOL may help improve the VBAC rate.

Foley catheter technique for the extraction of coins lodged in the upper esophagus of children.

INTRODUCTION: Coins are the most commonly ingested foreign bodies in children. They usually become lodged in the upper oesophagus and should be managed immediately. The aim of the present study was to evaluate the characteristics and outcomes of patients with coins lodged in the upper oesophagus, who underwent coin removal using a silicone Foley balloon catheter without fluoroscopy or anaesthesia and evaluate the safety of the procedure. MATERIALS AND METHODS: Patients who were admitted from January 2007 to December 2022 for coins lodged in the oesophagus and extracted with silicone Foley balloon catheter without anestehesia were evaluated retrospectively. We focused on the patient characteristics and clinical presentations, and the treatment safety, efficacy, and outcomes. RESULTS: 773 patients (416 male, 357 female), with a mean age of 3.5 years (range 6 months to 16 years), who ingested coin and extracted with Foley catether is included. The majority of patients (n = 728, 94.17%) were successfully managed by silicone Foley balloon catheter extraction. Our overall success was 94.17%, with 88.30% of coins retrieved and 5.9% pushed into the stomach. Patients who were successfully treated with Foley catheter were discharged on the same day except for 7 (0.90%) who had minimal bleeding. Only 45 (5.82%) patients required oesophagoscopy in the operating room and these patients were kept overnight for clinical follow-up, without any further interventions. CONCLUSION: A Foley balloon catheter can be used to safely and effectively remove coins that are lodged in the upper oesophagus avoiding the risk of general anesthesia.

Double-balloon catheter vs dinoprostone (PGE-2) insert for labour induction: A meta-analysis of 2493 pregnancies.

Induction of labor (IOL) is the stimulation of the uterus during pregnancy to begin the onset of labour. Nearly two of five pregnancies require IOL. We compared the effectiveness of double-balloon catheter (DBC) with dinoprostone (PGE-2) insert for labour induction from previous studies. We included randomized controlled trials (RCTs) that compared the safety and efficacy of DBC to PGE-2. To evaluate the studies, we utilized the Cochrane tool for risk of bias assessment. The rates of vaginal birth and cesarean section were the primary outcomes. We included ten RCTs in this meta-analysis with a total sample of 2493 singleton pregnancies. After 24 hours, there was no significant difference in the delivery rates between DBC and PGE-2 s [R.R=1.08, 95% CI, (0.77, 1.52), P.value=0.65], and the rate of cesarean delivery [R.R=1.03, 95% CI, (0.90; 1.18), P.value=0.65]. The DBC showed a significantly higher oxytocin use rate compared to the PGE-2 group [R.R=1.77, 95% CI, (1.41; 2.32), P.value<0.0001]. In the PGE-2 group, there was a significantly higher risk of uterine hyperstimulation, tachysystole, and umbilical artery PH levels below 7. There was no significant difference in the efficacy between the PGE-2 and DBC in terms of delivery rate in 24 hours and the rate of cesarean delivery except for a slight BISHOP score improvement with DBC. However, DBC showed a higher rate of oxytocin use compared to the PGE-2, the DBC seems to be safer with a lower risk of umbilical artery PH < 7, uterine hyperstimulation, and tachysystole incidence than PGE-2.

Clinical and Health Economic Evaluation of a Novel Device for Fecal Management in Bedridden Patients.

Purpose: To evaluate the clinical effectiveness and health economic benefits of a novel indwelling lattice-based device for fecal management in bedridden patients. Materials and methods: This nonrandomized, two-arm study included 70 bedridden patients (≥18 years exhibiting liquid stool) referred from the ICU of surgery and medicine units of a 2000-bed tertiary care referral hospital, assigned to the intervention and control groups. About 35 patients were eligible to be included in the intervention group while 35 patients with contraindications to the intervention device were included in the usual care control group. Assessments were made before and every 24 hours during the study, and all patients were closely monitored for development of incontinence-associated dermatitis (IAD) and hospital-acquired pressure injury. Results: The test device was successfully deployed on the first attempt and effectively diverted fecal matter in all 35 patients, with no adverse events. In the control group, 83% of the patients developed IAD, which resulted in prolonged hospitalization and increased expenses. Overall, the control group (with adult diapers) required greater time, resources, and efforts for fecal management and resulted in increased patient morbidity. Conclusion: The patient management time, resource consumption, overall cost of hospital admission, and the complication rates are significantly lower with the use of the novel lattice-based device than with the use of adult diapers for fecal management. How to cite this article: Sheth H, Rao S, Karthik V. Clinical and Health Economic Evaluation of a Novel Device for Fecal Management in Bedridden Patients. Indian J Crit Care Med 2023;27(10):759-765.

A novel "proximal first" Inoue balloon catheter for retrograde aortic valvuloplasty: Initial case report.

The Inoue balloon, invented for percutaneous transseptal mitral commissurotomy for mitral stenosis, is initially dilated in the distal portion and then the proximal portion, forming an hourglass shape that stabilizes the balloon at the mitral valve orifice with a pulling action. The device has been successfully applied to antegrade aortic valvuloplasty; the hourglass shape stabilizes the balloon across the aortic valve without rapid ventricular pacing. Subsequently, an Inoue balloon was developed for retrograde aortic valvuloplasty using the same design as the antegrade balloon. The hourglass-shaped balloon, however, has difficulty maintaining stability across the aortic valve because the distal portion of the balloon, which inflates first, directly receives systolic pressure from the left ventricle. A novel Inoue balloon was invented to overcome this issue by altering the manner of inflation: the proximal portion inflates first, followed by the distal portion. Theoretically, the proximal portion, which initially inflates just above the aortic valve, remains secure across the valve by applying a pressing force that counteracts the systolic forward pressure. Furthermore, a radiopaque marker is placed at the center of the balloon to enable rapid and precise balloon adjustment. We present a case involving a 65-year-old female hemodialysis patient with severe symptomatic aortic stenosis who we successfully treated with balloon aortic valvuloplasty using the novel Inoue balloon followed by transcatheter aortic valve implantation. The present case demonstrates the feasibility and effectiveness of the novel "proximal first" Inoue balloon for retrograde balloon aortic valvuloplasty for severe aortic stenosis.

Prospective Study of Serration Angioplasty in the Infrapopliteal Arteries Using the Serranator Device: PRELUDE BTK Study.

PURPOSE: The purpose was to evaluate the safety and efficacy of the Serranator percutaneous transluminal angioplasty serration balloon catheter in patients with infrapopliteal peripheral artery disease. MATERIALS AND METHODS: A prospective, multicenter, single-arm feasibility study in 46 patients with claudication or chronic limb-threatening ischemia, Rutherford Clinical Category (RCC) 3 to 5, that required treatment of the infrapopliteal arteries above the tibiotalar joint. The primary efficacy outcome was device success-successful insertion, balloon inflation and deflation, and removal of the device(s) with a final diameter stenosis of <50%. The primary safety endpoint was a composite of major adverse limb events (MALE) and perioperative death (POD) through 30 day postprocedure. Other outcomes were change in RCC and ankle-brachial index, wound healing, and clinically-driven target lesion revascularization (CD-TLR). A subset of 9 patients were further evaluated by optical coherence tomography (OCT) or intravascular ultrasound (IVUS) for the presence of serrations in treated lesions. Patient follow-up occurred at 30 days and 6 months. RESULTS: Forty-six patients received treatment with the Serranator device and 55 lesions were treated. Fifty-three lesions were deemed analyzable by the core lab with data and reported hereafter. Device success was 91.7% and freedom from MALE + POD through 30 days was 95.7%. Pretreatment stenosis of 82% was reduced to 21.8% and only 1 lesion (1.9%) required a bailout stent for a grade D dissection. The average maximum balloon inflation pressure was 6 atmospheres. Serrations were present in all treated lesions (n=10) in 9 patients imaged with OCT/IVUS as reviewed by the core laboratory. The RCC score improved by 1 or more level in 70% of patients at 6 months with 42% having a score of 0. The 6 month freedom from CD-TLR was 97.7%. CONCLUSION: Serranator treatment of infrapopliteal lesions showed excellent lumen gain with minimal evidence of arterial injury and low 6 month CD-TLR. Imaging by IVUS and OCT showed serrations without significant dissection, supporting the device's proposed mechanism of action.

Safety and efficacy of double-balloon catheter for cervical ripening: a Bayesian network meta-analysis of randomized controlled trials.

BACKGROUND: Various methods are used for cervical ripening during the induction of labor. Mechanical and pharmacological methods are commonly used for cervical ripening. A double-balloon catheter was specifically developed to ripen the cervix and induce labor; however, the efficacy of the double-balloon catheter in cervical ripening compared to other methods is unknown. METHODS: We searched five databases and performed a Bayesian network meta-analysis. Six interventions (double-balloon catheter, Foley catheter, oral misoprostol, vaginal misoprostol, dinoprostone, and double-balloon catheter combined with oral misoprostol) were included in the search. The primary outcomes were cesarean delivery rate and time from intervention-to-birth. The secondary outcomes were as follows: Bishop score increment; achieving a vaginal delivery within 24 h; uterine hyperstimulation with fetal heart rate changes; need for oxytocin augmentation; instrumental delivery; meconium staining; chorioamnionitis; postpartum hemorrhage; low Apgar score; neonatal intensive care unit admission; and arterial pH. RESULTS: Forty-eight randomized controlled trials involving 11,482 pregnant women were identified. The cesarean delivery rates of the cervical ripening with a double-balloon catheter and oral misoprostol, oral misoprostol, and vaginal misoprostol were significantly lower than cervical ripening with a Foley catheter (OR = 0.48, 95% CI: 0.23-0.96; OR = 0.74, 95% CI: 0.58-0.93; and OR = 0.79, 95% CI: 0.64-0.97, respectively; all P < 0.05). The time from intervention-to-birth of vaginal misoprostol was significantly shorter than the other five cervical ripening methods. Vaginal misoprostol and oral misoprostol increased the risk of uterine hyperstimulation with fetal heart rate changes compared to a Foley catheter. A double-balloon catheter with or without oral misoprostol had similar outcomes, including uterine hyperstimulation with fetal heart rate changes compared to a Foley catheter. CONCLUSION: Double-balloon catheter did not show superiority when compared with other single method in primary and secondary outcomes of labor induction. The combination of double-balloon catheter with oral misoprostol was significantly reduced the rate of cesarean section compared to Foley catheter without increased risk of uterine hyperstimulation with fetal heart rate changes, which was shown in oral or vaginal misoprostol.