Balloon Group Research Articles

The impact of post PCNL tube type on blood loss and postoperative pain.

Objective:To evaluate the impact of nephrostomy tube type on postoperative pain and blood loss following percutaneous nephrolithotomy (PCNL).Methods:This is a prospective non-randomized study performed at Aga Khan University Hospital from July 2017 to June 2018. In this study we prospectively studied adult patients (16 to 65 years) who underwent unilateral PCNL. Patients who had nephrostomy with balloon (12Fr Foley’s catheter) were compared with patients who had nephrostomy without balloon (12Fr Nelaton™ catheter). STONE Nephrolithometry score was used to assess the stone complexity. Mean pain score at six and 24 hours and mean hemoglobin drop at 24 hours was compared between two groups using independent sample t-test, p-value of <0.05 was considered significant.Results:Over one year, 198 PCNL were performed out of which 119 were included for analysis. Sixty-six had nephrostomy tube with balloon and 53 had nephrostomy tube without balloon. Mean STONE score (9.66±1.4 vs. 9.64±1.24) and operative time (72.84±28.34 vs. 86.05±32.1 minutes) was comparable. Mean postoperative pain score at 6 hours and 24 hours postoperative was significantly lower in balloon group as compared to without balloon group. Mean Hemoglobin drop was similar in both groups (p=0.60).Conclusion:The use of nephrostomy tube with balloon after PCNL as this is associated with less pain and comparable hemoglobin drop as compare to nephrostomy tube without balloon.

646 A Ceasefire: Matched Analysis of Balloon vs Surgical Valvotomy for Congenital Aortic Stenosis

Balloon valvuloplasty and surgical aortic valvotomy have been the treatment mainstays for congenital aortic stenosis in children. Choice of intervention often differs depending upon center bias with limited relevant, comparative literature. This study aims to provide an unbiased, contemporary matched comparison of these balloon and surgical approaches. Retrospective analysis of patients with congenital aortic valve stenosis who underwent balloon valvuloplasty (Queensland Children’s Hospital) or surgical valvotomy (Royal Children’s Hospital, Melbourne) between 2005 and 2016. Patients were excluded if pre-intervention assessment indicated ineligibility to either group. Propensity-score-matching was performed based on age, weight and valve morphology. Sixty-five balloon patients and seventy-nine surgical patients were included. Overall the groups were well matched with 18 neonates / 25 infants in the balloon group and 17 neonates / 28 infants in the surgical group. Median age at balloon was 92 days (range 2 days - 18.8 years) compared to 167 days (range 0 days – 18.1 years) for surgery (Rank-sum p=0.08). Mean follow-up was 5.3 years. There was 1 late balloon death and 2 early surgical deaths due to left ventricular failure. There was no significant difference in freedom from re-intervention (FFI) at latest follow-up (69% in the balloon group and 70% in the surgical group, p=1.0). Contemporary analysis of balloon aortic valvuloplasty and surgical aortic valvotomy shows no difference in overall reintervention rates in the medium-term. Balloon valvuloplasty performs well across all age groups, achieving delay or avoidance of surgical intervention.

Efficacy and Safety of TurboHawk Plaque Rotation Combined With Drug-coated Balloon in Treating Diabetic Patients With Lower Extremity Arterial Disease.

To evaluate the efficacy and safety of TurboHawk plaque rotation system combined with drug-coated balloon in treating lower extremity arterial disease (LEAD) of diabetes patients, a total of 145 diabetic patients with LEAD from March 2015 to September 2016 were recruited in our study. Lower extremity arterial disease was diagnosed by ultrasound and CT angiography (CTA). According to the surgical method, 65 cases underwent TurboHawk plaque rotation combined with drug-coated balloon (group A), 80 cases underwent simple drug-coated balloon expansion (group B). The characteristics of lesion, function test, ankle-brachial index (ABI), and postoperative complications were analyzed. All the patients were followed up at 1, 3, 6, 12, and 24 months after operation. At baseline, there was no difference in all the characteristics between the 2 groups. The early postoperation minimum lumen diameter (MLD), lumen stenosis rate, and ABI in 2 groups both improved. As the follow-up time increased, patients in group A had significantly higher MLD and ABL value, as well as lower level of lumen stenosis rate, restenosis rate, late lumen loss, and target lesion revascularization (all P < .05). Accordingly, functional testing revealed the 6-minute walk distance, 6-minute claudication distance, resting ABI, and post-exercise ABI in group A were significantly higher than those in group B (all P < .05). Besides, major graft reintervention (4.62% vs 11.25%) and major adverse limb events (6.15% vs 12.5%) in group A occurred less frequently than group B (all P < .05). In conclusion, the long-term effect of the combined approach was better than only drug-coated balloon in LEAD in Chinese diabetes patients.

Application and Care of Two Kinds of Sphenoid Sinus Packing Materials after Pituitary Tumor Resection with the Transnasal Endoscopic Approach

Background: Neuroendoscopic transsphenoidal approach for resection of pituitary adenomas has the advantages of less damage, fewer complications, and a faster recovery than the traditional approach and has beening favored by neurosurgeons. However, there has no standard method of selecting suitable packing materials after the operation to relieve pain in patients and achieve the ideal hemostatic effect. We compared the postoperative complications and treatment effects of two different packing materials in patients with pituitary adenomas. Objective: To investigate the advantages and disadvantages of using a catheter balloon and iodoform gauze for hemostasis in patients undergoing pituitary tumor resection by neuroendoscopic transsphenoidal approach. Materials and Methods: We retrospectively analyzed these data of 48 cases treated with pituitary adenoma resection by the single nasal approach from January 2018 to October 2019 in Sun Yat-sen University Cancer Center. According to the type of sphenoid sinus packing material used, these patients were divided into balloon tamponade oppression group (24 cases) and tela iodoformum oppression group (24 cases), respectively. The balloon tamponade oppression group received catheter balloon tamponade oppression hemostasis, and the tela iodoformum oppression group underwent tela iodoformum oppression hemostasis. The outcomes and complications were compared between the two groups in which two kinds of sphenoid sinus packing materials were used for hemostasis after tumor resection by transnasal endoscopic approach. For the catheter balloon compression hemostasis method, on account of the plasticity of the balloon, the volume of water in the balloon can be adjusted according to the size of the patient’s own sphenoid cavity. The amount of bleeding and several complications in terms of discomfort during placement and removal of the packing material, rebleeding after removal of the packing, cerebrospinal fluid rhinorrhea and electrolyte disturbance are compared between the two groups. Results: 48 patients were enrolled. The two groups’ data of patients were similar in age structure, sex ratio, tumor size at baseline and so on. No complications, such as abscess formation, were found in both groups. The success rate in the compression with catheter balloon group was 100% (24 of 24 patients); and in the iodoform gauze group 83.33% (20 of 24 patients). A catheter balloon was more successful in stopping bleeding at early stage than iodoform gauze. There were no statistically significant differences in the hospitalization stay time, operating day to discharge day and tampon indwelling time (P > 0.05). There were also no significant differences in pairwise comparison between the catheter balloon group and iodoform gauze groups in the incidence of cerebrospinal fluid rhinorrhea or electrolyte disturbance between the two groups (P > 0.05). The incidence of headache in the catheter balloon group was statistically significantly lower than that in the iodoform gauze group (P

1020: The consequences of balloon induction on the risk for concomitant preterm birth

The prevalence of elective inductions is anticipated to increase in the years to come due to growing body of evidence demonstrating improved birth outcomes. Nevertheless, concerns have been raised regarding mechanical iatrogenic disruption of the cervical stroma due to induction of labor, with possible increased risk for preterm birth. Therefore, the aim of this study is to evaluate subsequent pregnancy outcomes following balloon induction. A retrospective case control study including all women who underwent induction of labor at a single tertiary care center, between December 2011 to August 2018. Study group included women after elective balloon induction (n=737) were compared to women induced by slow release vaginal PGE2 (Propess) (n=112). Inclusion criteria included: ≥37 weeks of gestation, concomitant spontaneous labor and singleton pregnancy. Women after cesarean delivery and multiple gestational pregnancy were excluded. Demographics, obstetrical characteristics and pregnancy outcomes were compered between groups. Data were analyzed using non-parametric tests. Age, gravidity and parity were comparable between the groups. No differences were observed in the concomitant gestational age at birth [40.3 (39.1-40.4) vs. 39.3 (38.1-40.5), balloon and slow release vaginal PGE2 respectively; p=0.12]. Furthermore, delta between concomitant to previous delivery week was comparable between groups (p=0.73). Normal vaginal delivery was reported in 91.9% (n=679) and in 93.8% (n=105) of the balloon and slow release vaginal PGE2 groups, respectively (p=0.49). Cervical dynamics was not seen in any of the patients in both groups. Balloon induction of labor was not associated with earlier gestation in concomitant delivery.

Induction of labour using prostaglandin E2 as an inpatient versus balloon catheter as an outpatient: a multicentre randomised controlled trial.

To compare clinical outcomes following induction of labour (IOL) using a balloon catheter and going home, versus prostaglandin (PG) as an inpatient. Randomised controlled trial. Eight Australian maternity hospitals. Women with uncomplicated term singleton pregnancies undergoing IOL for low-risk indications including post-term, advanced maternal age and 'social' reasons. Between September 2015 and October 2018, 347 women were randomised to a balloon outpatient group and 348 to a PG inpatient group. The PG group received Dinoprostone, either 2mg gel or 10mg controlled-release tape. The balloon group had a double-balloon catheter inserted and went home. The primary outcome was a composite neonatal measure comprising nursery admission, intubation/cardiac compressions, acidaemia, hypoxic ischaemic encephalopathy, seizure, infection, pulmonary hypertension, stillbirth or death. Clinical and process outcomes are reported. There were no statistically significant differences in the primary outcome comparing balloon with PG (18.6% versus 25.8%; relative risk=0.77, 95% CI 0.51-1.02; P=0.070), cord arterial pH <7.10 (3.5% versus 9.2%; P=0.072), nursery admissions (12.6% versus 15.5%; P=0.379), neonatal antibiotic use (12.1% versus 17.6%; P=0.103), or mode of birth. Nulliparous women in the balloon group had lower rates of the primary outcome (20.4% versus 31.0%;P=0.032); Parous women were less likely to have an unassisted vaginal birth (77.6% versus 92.3%; P=0.045). Balloon catheters may be a superior method of cervical priming for nulliparous women, whereas this may not be the case for parous women. It is feasible that nulliparous women go home after commencing balloon catheter IOL, and the likelihood of adverse outcomes is low. Multicentre trial shows outpatient induction using balloon catheter is safe and feasible for nulliparous women.

Double balloon catheters: A promising tool for induction of labor in multiparous women with unfavorable cervices

Objective:To compare the effectiveness and safety of oxytocin and a cervical ripening balloon in women with unfavorable cervices for inducing labor.Material and Methods:A total of eighty pregnant women between 37-41 gestational weeks having singleton pregnancies and intact membranes with unfavorable cervices were randomized into two groups, cervical ripening balloon (n=40) and oxytocin infusion (n=40). The primary outcomes were the labor time and the route of delivery. Secondary outcomes were the effect of parity on time of labor, and obstetric and perinatal outcomes.Results:The median time to delivery was 9.45 hours in cervical ripening balloon group and 13.2 hours in the oxytocin group in multiparous women. The differences were statistically significant (p<0.001). The median time until delivery was 11.48 hours in cervical ripening balloon group and 13.46 hours in the oxytocin group; the differences were statistically significant (p<0.001). Cesarean delivery ratios were similar in both groups (p=0.431).Conclusion:The results of the present study are promising for balloon use, especially in multiparous women. It is beneficial to support these data with wide ranging population-based studies.

Double-balloon catheter compared with single-balloon catheter for induction of labor with a scarred uterus

BackgroundIn obstetrics, labor induction is a common procedure. It has been proved that both single balloon catheters (Foley’s catheter) and double balloon catheters (Cook cervical ripening balloon) are effective and relatively safe in cervical ripening and labor induction. This research aimed to compare the efficacy of single and double balloon catheter in the induction of labor with scarred uterus. Methods120 pregnant women who had prior cesarean delivery participated in this research and were randomized into single-balloon catheter group (n = 60) and double-balloon catheter group (n = 60). The cervical ripening effect, security, and influence to the process of childbirth were analyzed in each group. ResultsThe validity of cervical ripening in single balloon group was better than double balloon group. Double balloon catheters increased the time between insertion and expulsion of the catheter and decreased spontaneous catheter expulsion rate. All the neonatal outcomes in these two groups were comparable. ConclusionBased on our data, the two different catheters both have their pros and cons in the labor induction of pregnant women with scarred uterus. The appropriate catheter used based on specific circumstance will improve the quality of labor induction.

Intraoperative infrarenal aortic balloon occlusion in pregnancies with placenta accreta, increta, and percreta

Objective: The objective of this study was to evaluate the efficacy of intraoperative aortic balloon occlusion (IABO) during cesarean section for placenta accreta, increta or percreta. Materials and Methods: This was a retrospective case-control study of patients with surgically or pathologically confirmed placenta accreta, increta or percreta who were examined from 2013 to 2017. One hundred and two patients (60%) had aortic balloon catheters placed before cesarean section (balloon group), and the other patients did not undergo balloon placement (control group). Clinical records from 170 subjects were reviewed. Results: Forty-nine patients were diagnosed as having placenta accreta (28.8%), 98 patients had placenta increta (57.6%), and 23 patients had placenta percreta (13.6%). Considering all subjects, the patients in the balloon group had a significantly reduced median estimated blood loss (p &lt; 0.01), rate of transfusion (p = 0.02), amount of packed red blood cells (PRBCs) (p = 0.02), and decrease in hemoglobin levels (p = 0.03). Nine (8.8%) patients had catheterization-related complications, including eight cases of arterial or venous thrombosis. When the data were analyzed separately according to the different forms of abnormal invasive placenta, no difference in these surgical outcomes was observed between the two groups for women with placenta accreta or placenta percreta; however, for women with placenta increta who underwent IABO, the authors observed significant reductions in the estimated blood loss (p &lt; 0.01), the amount of transfused PRBCs (p = 0.01), the extent to which hemoglobin levels decreased after surgery (p = 0.01), and the incidence of cesarean hysterectomy (p = 0.04). Conclusions: Although IABO was efficacious in both reducing intraoperative hemorrhage and blood transfusion, and in preventing hysterectomy during cesarean section for placenta increta, it should only be used on the basis of an accurate antenatal diagnosis, as it has a high risk of thrombosis and a high cost; immediate cesarean hysterectomy still seems to be the optimal management for placenta percreta.

Iloprost treatment on top of infrapopliteal angioplasty accelerates wound healing in critical leg ischemia

Objectives This study aimed to examine the efficacy of the concomitant use of infrapopliteal drug-eluting balloon angioplasty and a medical treatment (iloprost) in the treatment of critical leg ischemia. Methods Eighty-seven patients that underwent infrapopliteal drug-eluting balloon angioplasty for critical leg ischemia were included in this retrospective study. For analyses, patients were allocated into one of the two groups: 55 patients that underwent drug-eluting balloon angioplasty alone (drug-eluting balloon Group), and 32 patients that received intravenous iloprost for one week after drug-eluting balloon (DEB-I Group). Demographic, perioperative and follow-up clinical data were extracted retrospectively and analyzed. Results Duration of hospitalization was significantly longer in the DEB-I group (9.7 vs. 3.1 days, p &lt; 0.001); however, the two groups were similar in terms of other clinical outcomes including early postoperative mortality, and primary patency, wound healing, reintervention, mortality, and amputation rates at one year ( p &gt; 0.05 for all). Primary patency was similar across groups. Wound healing occurred earlier in the DEB-I group when compared to drug-eluting balloon group, in the subgroup of patients with ischemic wound at baseline. Mean time to wound healing was 3.0 ± 0.6 and 4.4 ± 0.6 months in DEB-I and drug-eluting balloon groups, respectively ( p = 0.037). Conclusions Iloprost add-on treatment in patients undergoing drug-eluting balloon angioplasty for critical limb ischemia seems to have additional benefits, at least in terms of accelerated wound healing. Further large prospective studies are warranted.

Low-Dose Paclitaxel-Coated Balloon Angioplasty versus Uncoated Percutaneous Transluminal Balloon Angioplasty for Femoropopliteal Peripheral Artery Disease: 6-Month Results in a Tertiary Care Hospital of Central India

Abstract Introduction Superficial femoral and popliteal arteries are the most common locations of peripheral vascular disease (PVD). Endovascular interventional therapy including drug-coated balloon (DEB) angioplasty or percutaneous transluminal angioplasty (PTA) and stenting are important options for treatment of PVD. Aims and Objectives The main objective is to compare the efficacy of DEB over PTA with optional stenting in management of obstructive femoropopliteal lesions in terms of 6-month patency rate. Materials and Methods The clinical experimental study was carried out in a tertiary care center over duration of 2 years. All symptomatic patients having lower limb PVD in femoropopliteal segment were included. Total 37 patients were included in this study in which 16 underwent plain balloon angioplasty (with 3 patients undergoing bare metal stenting [BMS]) and 21 additional underwent DEB angioplasty. Patients with previously intervened lesions, primary lesion failure, major ischemic tissue loss, poor aortoiliac or common femoral inflow, or end-stage kidney disorders were excluded. Result At 1-month follow-up, patency rates in DEB and conventional PTA ± BMS were 85.71% and 87.5%, respectively. On 6-month follow-up, patency rates were found to be 71.4% versus 37.5%, respectively (p = 0.039; significant). In case of occluded lesions, on 6-month follow-up, patency rate in DEB group was higher than that in plain balloon group (66.7% vs. 25%). In both the cohorts, success rate, i.e., patency rates were more in short and intermediate length lesions than long segment lesions. DEB was found to be superior to plain angioplasty with optional stenting in terms of 6-month patency rate.

Comparison Between Endoscopic Biliary Stenting Combined with Balloon Dilation and Balloon Dilation Alone for the Treatment of Benign Hepaticojejunostomy Anastomotic Stricture

BackgroundHepaticojejunostomy anastomotic stricture (HJAS) is an important complication of biliary reconstructive surgery but has no standard treatment. We aimed to evaluate the outcomes of endoscopic treatment for benign HJAS and identify the risk factors for its recurrence. MethodsThis study retrospectively analyzed 176 patients who underwent endoscopic retrograde cholangiopancreatography (ERCP) for HJAS between April 2008 and March 2016. The outcome of endoscopic biliary stenting combined with balloon dilation (EBS group) and balloon dilation alone (balloon group) was evaluated. ResultsThe scope was successfully inserted into the HJ site in 93.8% patients (165/176), and 139 patients underwent endoscopic treatment after HJAS was confirmed. Successful biliary drainage was achieved in 137 patients by using ERCP and rendezvous procedures. Among these, 103 patients were included in balloon group and 34 patients were in EBS group. HJAS was resolved in 132 patients; five died from recurrence of primary disease. The 1 (3)-year bile duct patency rates in the balloon and EBS groups were 62.5% (46.6%) and 89.4% (84.7%), respectively (p = 0.015). Univariate analysis showed that balloon dilation (p = 0.009) and early HJAS formation (time from surgery to ERCP < 1 year) (p = 0.02) were risk factors for HJAS recurrence. In the multivariate analysis, balloon dilatation was identified as independent risk factors for HJAS recurrence. ConclusionsBalloon dilation without stent deployment and early HJAS formation are risk factors for HJAS recurrence after endoscopic treatment. Stent deployment might be recommended for definite resolution of HJAS.

Drug-coated balloon for treatment of de-novo coronary artery lesions in patients with high bleeding risk (DEBUT): a single-blind, randomised, non-inferiority trial

The optimal technique of percutaneous coronary intervention in patients at high bleeding risk is not known. The hypothesis of the DEBUT trial was that percutaneous coronary intervention with drug-coated balloons is non-inferior to percutaneous coronary intervention with bare-metal stents for this population. The DEBUT trial is a randomised, single-blind non-inferiority trial done at five sites in Finland. Patients were eligible if they had an ischaemic de-novo lesion in a coronary artery or bypass graft that could be treated with drug-coated balloons, at least one risk factor for bleeding, and a reference vessel diameter of 2·5-4·0 mm. Those with myocardial infarction with ST-elevation, bifurcation lesions needing a two-stent technique, in-stent restenosis, and flow-limiting dissection or substantial recoil (>30%) of the target lesion after predilation were excluded. After successful predilation of the target lesion, patients were randomly assigned (1:1), by use of a computer-generated random sequence, to percutaneous coronary intervention with a balloon coated with paclitaxel and iopromide or a bare-metal stent. The primary outcome was major adverse cardiac events at 9 months. Non-inferiority was shown if the absolute risk difference was no more than 3%. All prespecified analyses were done in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT01781546. Between May 22, 2013, and Jan 16, 2017, 220 patients were recruited for the study and 208 patients were assigned to percutaneous coronary intervention with drug-coated balloon (n=102) or bare metal stent (n=106). At 9 months, major adverse cardiac events had occurred in one patient (1%) in the drug-coated balloon group and in 15 patients (14%) in the bare-metal stent group (absolute risk difference -13·2 percentage points [95% CI -6·2 to -21·1], risk ratio 0·07 [95% CI 0·01 to 0·52]; p<0·00001 for non-inferiority and p=0·00034 for superiority). Two definitive stent thrombosis events occurred in the bare metal stent group but no acute vessel closures in the drug-coated balloon group. Percutaneous coronary intervention with drug-coated balloon was superior to bare-metal stents in patients at bleeding risk. The drug-coated balloon-only coronary intervention is a novel strategy to treat this difficult patient population. Comparison of this approach to the new generation drug-eluting stents is warranted in the future. B Braun Medical AG, AstraZeneca, and Competitive State Research Funding of the Kuopio University Hospital Catchment Area.

Interest of cervical ripening using double balloon catheters for labour induction in term nulliparous women

Objective: To compare the efficiency of double balloon catheters with that of intravaginal prostaglandins alone for the labor induction of unfavourable cervices in term nulliparous women.Methods: 50 nulliparous patients induced with a double balloon device were compared to 53 patients induced using intravaginal prostaglandins alone. The main outcome measure was labour induction failure, characterized by the absence of active labour. The secondary outcome measures were the improvement of the Bishop score, the average durations of ripening and labour induction, the average time to active labour, the need for a second cervical ripening agent, the total dose of prostaglandins used in each group, the use of oxytocins, as well as the rates of vaginal delivery, abnormal foetal heart rate during labour and perinatal maternal infection.Results: The rate of failed labour induction was of 28% in the double balloon group, against 13% in the prostaglandins group. The average durations of ripening and labour induction, as well as the time to active labour were higher in the double balloon group. The improvement of the Bishop score was significantly lower in the double balloon group.Discussion and conclusion: In our study, the use of double balloon catheters does not seem to reduce the rate of failed labour induction in nulliparous women when compared to the use of prostaglandins alone. In addition, it could lengthen the labour induction duration, although more powerful studies would be necessary not to recommend its use for nulliparous women.

Meta-analysis of the effects of drug-coated balloons among patients with small-vessel coronary artery disease.

Objective:This study evaluated the clinical value of drug-coated balloons for patients with small-vessel coronary artery disease (SVD).Methods:A computerized literature search was performed using the databases to conduct a meta-analysis and evaluate the clinical value of drug-coated balloons among patients with SVD.Results:This review enrolling 1545 patients receiving drug-coated balloons and 1010 patients receiving stents (including drug-eluting stents and bare-metal stents). The meta-analysis results showed that the incidence of major adverse cardiovascular events among patients with SVD did not significantly differ between the drug-coated balloon group and the stent group within 1 postoperative year (odds ratio = 0.81, P = .5). A subgroup analysis showed that the incidence of myocardial infarction among the drug-coated balloon group was significantly lower than that among the stent group (odds ratio = 0.58, P = .04). Nevertheless, the late lumen loss of the drug-coated balloon group was significantly lower than that of the stent group (mean difference = 0.31, P = .01).Conclusions:Drug-coated balloons can be used to effectively reduce the incidence of myocardial infarction in patients with SVD within 1 year and decrease the extent of late lumen loss without increasing the incidence of major adverse cardiovascular events.

Internal iliac artery balloon occlusion during cesarean hysterectomy in women with placenta previa accreta.

To investigate the effect of balloon occlusion of internal iliac arteries during cesarean hysterectomy in women with placenta previa accreta. Retrospective cohort study conducted using medical records of women with placenta previa and pathologically confirmed accreta taken from a single tertiary center in Chengdu, China, between January 1, 2012 and December 31, 2017. Baseline characteristics and pregnancy outcomes were compared between women with and without balloon occlusion of internal iliac arteries during cesarean delivery. The primary outcome was a composite outcome: estimated blood loss greater than or equal to 3.0L, massive transfusion (transfusion of 10 or more units of packed red blood cells), and maternal intensive care unit admission. There were 114 patients included in the study, 83 (72.8%) in the balloon group and 31 (27.2%) in the control group. Both propensity score analysis (18 [78.3%] vs 15 [65.2%], P=0.326) and multivariate logistic analysis (adjusted odds ratio 0.54, 95% confidence interval 0.20-1.45; P=0.221) showed that intraoperative balloon occlusion of internal iliac arteries was not associated with the primary outcome. Balloon occlusion of internal iliac arteries during cesarean hysterectomy in women with placenta previa accreta was not associated with improved maternal outcomes.

Percutaneous Epidural Adhesiolysis Using Inflatable Balloon Catheter and Balloon-less Catheter in Central Lumbar Spinal Stenosis with Neurogenic Claudication: A Randomized Controlled Trial

Background: When conventional interventional procedures fail, percutaneous epidural adhesiolysis (PEA), which has moderate evidence for successful treatment of lumbar spinal stenosis (LSS), has been recommended over surgical treatments. In a previous study, we demonstrated the efficacy of a newly developed inflatable balloon catheter for overcoming the access limitations of pre-existing catheters for patients with severe stenosis or adhesions. Objectives: This study compared the treatment response of combined PEA with balloon decompression and PEA only in patients with central LSS over 6 months of follow-up. Study Design: This study used a randomized, single-blinded, active-controlled trial design. Setting: This study took place in a single-center, academic, outpatient interventional pain management clinic. Methods: This randomized controlled study included 60 patients with refractory central LSS who suffered from chronic lower back pain and/or lumbar radicular pain. Patients failed to maintain improvement for &gt; 1 month with epidural steroid injection or PEA using a balloon-less catheter. Patients were randomly assigned to one of 2 interventions: balloon-less (n = 30) and inflatable balloon catheter (n = 30). The Numeric Rating Scale (NRS-11), Oswestry Disability Index (ODI), Global Perceived Effect of Satisfaction (GPES), and Medication Quantification Scale III were each measured at 1, 3, and 6 months after PEA. Results: There was a significant difference between groups in NRS-11 reduction ≥ 50% (or 4 points), ODI reduction ≥ 30% (or 10 points), GPES ≥ 6 and ≥ 4 points at 6 months, and NRS11 reduction ≥ 50% (or 4 points) at 3 months after PEA (P &lt; .03). The proportion of successful responders was higher in the balloon group than in the balloon-less group throughout the total follow-up period. Furthermore, there was a statistically significant difference between groups at 6 months after PEA (P = .035). Limitations: The results may vary according to the definition of successful response. Follow-up loss in the present study seemed to be high. Conclusion: PEA using the inflatable balloon catheter leads to significant pain reduction and functional improvement compared to PEA using the balloon-less catheter in patients with central LSS. The study protocol was approved by our institutional review board (2012-0235), and written informed consent was obtained from all patients. The trial was registered with the Clinical Research Information Service (KCT 0002093). Key words: Balloon decompression, central, chronic pain, epidural adhesiolysis, lumbar, percutaneous, radiculopathy, spinal stenosis

Percutaneous treatment of benign bilioenteric anastomotic strictures: temporary covered stent placement versus balloon dilatation.

To compare percutaneous temporary covered stent placement with balloon dilatation in the treatment of benign stricture of bilioenteric anastomosis. From November 2004 to August 2017, 56 patients with benign bilioenteric anastomotic strictures underwent percutaneous transhepatic treatment. A temporary covered stent designed for spontaneous migration was placed in 23 patients (stent group). Balloon dilatation was performed in 33 patients (balloon group). The technical success, percutaneous transhepatic biliary drainage (PTBD) indwelling times, stent indwelling times and patency rates were retrospectively compared between the two groups. Technical success was achieved in all patients in the stent group and in 96.8% (32/33) of patients in the balloon group. All stents spontaneously migrated into the jejunum, and stent indwelling times were 3-9months (median, 6months). The PTBD indwelling time was shorter for the stent group than for the balloon group (median, 7 vs. 71days, p = 0.001). Recurrent strictures occurred more frequently in the balloon group than in the stent group (54.5% vs. 13.0%, p =0.002; hazard ratio 3.7). The 1- and 3-year primary patency rates were 90.2% and 84.9% for the stent group and 75.1% and 52.8% for the balloon group, respectively (p = 0.04). Percutaneous temporary covered stenting is an effective treatment in patients with benign bilioenteric anastomotic strictures. It provides longer patency and shorter PTBD indwelling time compared with balloon dilatation. • A temporary covered stent designed for spontaneous migration is a feasible and effective treatment for patients with benign bilioenteric anastomotic strictures. • Percutaneous temporary covered stents provide longer patency and shorter drainage catheter indwelling time compared with conventional balloon dilatation. • A covered stent with flared ends spontaneously migrated after 3-9months.

Phrenic Nerve Limitation During Epicardial Catheter Ablation of Ventricular Tachycardia.

This study sought to investigate the incidence of phrenic nerve (PN) limitation and the utility of displacing the PN with a balloon. The PN can limit the epicardial ablation of ventricular tachycardia (VT). From 2010 to 2017, 363 patients undergoing VT epicardial ablation at a single center were studied. Before the ablation, we used high output (20-mA) pacing maneuvers to verify the course of the PN. When we observed its capture, we used 1 of 3 different approaches to protect it: 1) non-balloon strategy (nerve-sparing ablation); 2) PN displacement with a small balloon (6 mm× 20 mm); or 3) PN displacement with a large balloon (20 mm× 45 mm). PN capture occurred in 25 patients (7%) at the target ablation site. The most common cause was myocarditis (12 patients [48%]), and the incidence of the PN limitation was significantly higher in myocarditis than in other causes (19% vs. 4%, respectively; p= 0.0002). PN displacement was attempted in 7 patients by using large balloons and in 6patients with small balloons, resulting in successful PN displacements and complete late potential (LP) abolition in 6patients (86%) and 3 patients (50%), respectively. Among the 12 patients in whom the non-balloon strategy was used, only 1 patient (8%) achieved LP abolition (compared with the large balloon group; p= 0.002), whereas 3 patients experienced PN paralysis. The PN limited the epicardial ablation in 7% of patients. Because nerve-sparing ablations often resulted in PN injuries, a possible solution could be to displace the PN with a large balloon, leading to a safer procedure and completion of LP abolition.

Labor Induction in Late-Onset Fetal Growth Restriction: Foley Balloon versus Vaginal Dinoprostone

Objective: To compare vaginal delivery rate and perinatal outcomes of fetuses with late-onset fetal growth restriction (FGR) undergoing labor induction, depending on the method for cervical ripening (dinoprostone vs. Foley balloon). Material and Methods: We conducted a retrospective cohort study of 148 consecutive singleton gestations diagnosed with stage I late-onset FGR and Bishop score < 7, in which labor induction was indicated at ≥37 + 0 weeks. Before January 2016, cervical ripening was achieved with 10 mg of vaginal dinoprostone (n = 77) and afterwards with Fo­ley balloon (n = 71). Logistic regression analysis was used to estimate the association between mode of delivery and induction method. Results: Foley balloon had lower percentages of uterine tachysystole with fetal repercussion (4.2 vs. 16.9%, p = 0.01) and cesarean sections for suspected fetal distress (7.0 vs. 26.0%, p < 0.01) when compared to dino­prostone. Lower percentages of cesarean sections were found in the Foley balloon group (15.5 vs. 37.7%, p < 0.01). The odds ratio and adjusted odds ratio of cesarean section with dinoprostone were of 3.3 and 4.4, respectively. Perinatal mortality and severe morbidity were null in both groups. Conclusion: The use of Foley balloon resulted in a higher percentage of vaginal delivery compared to dinoprostone, with a favorable safety profile in both groups.