Balloon Device Research Articles

Abstract 427: Comparison of RF Renal Denervation Systems: Multiple Bipolar Electrodes With Blood Flow Control vs. Single Monopolar Electrode

Introduction: Boston Scientific’s Vessix TM Over-the-Wire (OTW) balloon catheter uses bipolar radiofrequency (RF) energy and blood flow control to deliver significantly less energy than monopolar RF renal denervation systems. We hypothesize that the greater energy used in monopolar RF systems increases the risk for non-target tissue injury and inconsistent lumenal lesion formation. Methods: A computational model was used to simulate the clinical settings and control algorithms of a monopolar single point catheter and bipolar balloon catheter. The electrical field was solved to calculate the Joule heating in tissue and a transient thermal model was solved for the temperature change for the duration of RF energy delivery. In a swine model, RF treated renal arteries and select psoas muscles were rinsed and submerged in a beaker containing TTC (Triphenyl Tetrazolium Chloride) solution to aide in identification of thermal lesions. Non-viable tissue does not metabolize the stain and remains white, in contrast to red stained viable tissue. Results: The computational model predicted that the monopolar RF lesion varied due to electrode-tissue contact conditions. Lesion depth was dependent on the electrical conductivity of the artery wall and structures near the electrode. In contrast, the Vessix bipolar balloon produced consistent lesion pattern and depth due to fixed balloon apposition and blood flow control, focal energy delivery, and the temperature control algorithm. TTC stained renal arteries treated with the bipolar balloon device had accurate & consistent electrode placement. The single electrode monopolar device had inconsistent tip placement, with lesion depths decreasing with decreasing treatment time. Non-target lesions (psoas muscle and bowel) were observed with the monopolar device. Psoas muscle thermal lesion depth decreased from 1.5mm with 120s ablation time (67% incidence) to 0.3mm with 30s ablation time (17% incidence) with a single electrode unipolar device (N=16). Non-target lesions were not observed with the bipolar balloon device (N=13). Conclusions: The BSC bipolar balloon renal denervation system had increased accuracy of electrode placement in the renal artery with no observations of non-target thermal injury.

Balloon Dilation in Rhinology: Reviewing the Evidence

Program Description: Balloon catheter technology was introduced in 2005 for management of paranasal sinus inflammatory disease. This miniseminar will objectively evaluate the currently available operative suite and office-based balloon devices. Rhinologists with considerable experience without commercial conflicts on balloons will assess the frank advantages and limitations of the current balloon devices. Evidence-based review will be incorporated to assess the strengths and weaknesses of the existing peer-review literature. The recent large European clinical trial will be reviewed. The potential complications unique to balloon catheters will be discussed. An update on CPT coding, RUC values, and socioeconomic implications will also be addressed. Educational Objectives: 1) Review the currently available operative suite and office-based balloon catheter technologies and explore implications on the Functional Endoscopic Sinus Surgery (FESS) paradigm. 2) Critically appraise the existing peer-review literature and address potential complications of balloon dilation. 3) Assess socioeconomic implications and CPT coding issues related to balloons.

A comparison of intrauterine balloon, intrauterine contraceptive device and hyaluronic acid gel in the prevention of adhesion reformation following hysteroscopic surgery for Asherman syndrome: a cohort study

ObjectiveTo compare the efficacy of intrauterine balloon, intrauterine contraceptive device and hyaluronic acid gel in the prevention of the adhesion reformation after hysteroscopic adhesiolysis for Asherman's syndrome. Study designRetrospective cohort study of 107 women with Asherman's syndrome who were treated with hysteroscopic division of intrauterine adhesions. After hysteroscopic adhesiolysis, 20 patients had intrauterine balloon inserted, 28 patients had intrauterine contraceptive device (IUD) fitted, 18 patients had hyaluronic acid gel instilled into the uterine cavity, and 41 control subjects did not have any of the three additional treatment measures. A second-look hysteroscopy was performed in all cases, and the effect of hysteroscopic adhesiolysis was scored by the American Fertility Society classification system. ResultsBoth the intrauterine balloon group and the IUD group achieved significantly (P<0.001) greater reduction in the adhesion score than that of the hyaluronic acid gel group and control group. The efficacy of the balloon was greater than that of the IUD (P<0.001). There was no significant difference in results between the hyaluronic acid gel group and the control groups. ConclusionThe insertion of an intrauterine balloon or intrauterine device is more effective than the use of hyaluronic acid gel in the prevention of intra-uterine adhesion reformation.

Le modafinil améliore les performances de conduite simulée des malades souffrant d’hypersomnie : étude randomisée placebo-verum

To report a novel technique for temporary and permanent vessel occlusion with a single microcatheter and investigate its efficacy in endovascular management of cerebral aneurysms and invasive head and neck tumors.A 58-year-old woman with a history of T3N0 squamous cell carcinoma of the tongue with extensive surgical resections and radiotherapy presented to the emergency department with further wound dehiscence and exposure of the left cervical internal carotid artery (ICA). Digital subtraction angiography (DSA) was performed with the patient under conscious sedation. An Ascent balloon, 4 mm × 15 mm, was prepared and introduced into the proximal ICA. While the patient was fully awake, temporary balloon occlusion (TBO) was performed for 30 minutes. The Ascent balloon was kept inflated. Through the inflated Ascent balloon, coil embolization of the proximal ICA was initiated. The interstices of the coils were filled with Onyx 18 and Onyx 34 liquid embolic agents (ev3 Neurovascular, Inc, Irvine, California, USA).The Ascent balloon can be used as a temporary balloon device and as a coil or Onyx embolization device. As a result, fewer catheters, guidewires, and balloon inflations and deflations are required for the procedure, which is both cost-effective and time-efficient. The combination of initial coiling to create a framework for the deconstruction with a liquid embolic agent (Onyx) is a safe and efficient technique for vessel deconstruction. Flow arrest with proximal balloon occlusion minimizes the risks of distal thromboembolic events during embolization.This novel technique for temporary and permanent vessel occlusion with a single microcatheter is both cost-effective and time-efficient.

Bakri Balloon in Vaginal-Perineal Hematomas Complicating Vaginal Delivery

The study aimed to evaluate the effectiveness of Bakri balloon as a hemostatic device in severe postpartum hemorrhage due to complicated vaginal-perineal hematoma not responsive to standard surgical treatments. The article discusses an effective and minimally invasive technique for resolving a case of massive vaginal-perineal bleeding after vaginal delivery complicated by ischiorectal fossa hematoma. A 36-year-old primipara white woman, 41 weeks 1 day pregnant, was admitted to our unit for beginning of labor. She experienced a precipitous delivery of a healthy male baby (3.72 kg, 51 cm in length), and spontaneous complete afterbirth of placenta and membranes. The intervention involved positioning of an hemostatic Bakri balloon device in the vagina, to compress the vaginal wall, ensuring that the draining apex was well positioned into the uterine cervix. The patient was discharged after having a puerperal course without further complications. Vaginal hemostatic Bakri balloon device shows hemostatic efficacy immediately assessable, is promptly removable, not interfering with subsequent surgical or radiological procedures, does not increase the risk of infections as other compressive procedures, allows flow of lochia, does not cause pain or discomfort in women, and permits adjustable compression when a drainage is placed during surgery. Despite the high cost, it does not show disadvantages.

Chest Wall Dose Assessment in Patients Treated Using Non-Invasive Image-Guided Breast Brachytherapy APBI

Purpose: This analysis compares the efficacy of a common clinical decision regarding selection of an abbreviated course of adjuvant radiotherapy for early-stage breast cancer: brachytherapy-based accelerated partial breast irradiation (APBI) vs. whole breast Canadian hypofractionated external beam radiation therapy. Materials and Methods: Patients were treated between November 1993 and November 2010 with APBI at 340 cGy BID for five days or Canadian Hypofractionation [CHfx] to the whole breast delivering 266 cGy per day for 16 fractions. The brachytherapy CTV was a 1cm expansion from the applicator surface for balloon devices and 1.5 to 2 cm from implanted interstitial catheters. For CHfx, the CTV was whole breast without boost irradiation. To compare efficacy between the two treatment groups, a matched-pair analysis was performed using a 1:1 ratio which paired 59 brachytherapy APBI patients with 59 patients treated via the CHfx dose scheme. Match criteria included minimal followup (FU) O1.0 yr, clinical stage, age (þ/3 yrs), and ER status. Clinical outcomes analyzed included freedom from local-regional recurrence [FRLR, FRRR], freedom from distant metastases (FRDM), disease-free, causespecific and overall survival [DFS, CSS, & OS]. Results: Matched exactly for stage and ER, no significant differences were noted for age (p50.775), nodal stage (p50.638), use of chemotherapy (p50.205) or endocrine therapy (p50.072) in the matched population. With a mean FU of 4.0 yrs (5.2 yrs for APBI vs. 2.8 yrs for CHfx, p! 0.001), no differences were seen in the 3-year actuarial rates of FRLR (98.3% vs. 100%, p50.317), DFS (98.3% vs. 100%, p50.317), or OS (91.0% vs. 100 %, p50.142); the 5-yr figures for these endpoints were likewise not statistically different. As well, no differences were seen in the 3and 5actuarial rates of FRRR, FRDM [both 100% at 3 & 5 yrs], or CSS [100% at 3& 5-yr intervals] between the APBI and CHfx groups, respectively. Conclusions: With a mean followup of 4 years, brachytherapy APBI offers similar treatment efficacy in a more time-compressed treatment course versus Canadian Hypofractionation while sparing dose to the remainder of the breast. Further FU and more patients will be needed to substantiate equivalence of brachytherapy-based APBI compared with whole breast CHfx, as well as the need for irradiation delivered to a volume beyond that prescribed for APBI in selected early-stage breast cancer patients.

Interstitial biodegradable balloon for reduced rectal dose during prostate radiotherapy: Results of a virtual planning investigation based on the pre- and post-implant imaging data of an international multicenter study

PurposeTo evaluate dose reduction caused by the implantation of an interstitial inflatable and biodegradable balloon device aiming to achieve lower rectal doses with virtual 3D conformal external beam radiation treatment. Materials and methodsAn inflatable balloon device was placed, interstitially and under transrectal ultrasound guidance, into the rectal–prostate interspace prior treatment initiation of 26 patients with localized prostate cancer, who elected to be treated with radiotherapy (3D CRT or IMRT). The pre- and post-implant CT imaging data of twenty two patients were collected (44 images) for the purpose of the 3D conformal virtual planning presented herein. ResultsThe dorsal prostate–ventral rectal wall separation resulted in an average reduction of the rectal V70% by 55.3% (±16.8%), V80% by 64.0% (±17.7%), V90% by 72.0% (±17.1%), and V100% by 82.3% (±24.1%). In parallel, rectal D2ml and D0.1ml were reduced by 15.8% (±11.4%) and 3.9% (±6.4%), respectively. ConclusionsInsertion of the biodegradable balloon into the prostate–rectum interspace is similar to other published invasive procedures. In this virtual dose distribution analysis, the balloon insertion resulted in a remarkable reduction of rectal volume exposed to high radiation doses. This effect has the potential to keep the rectal dose lower especially when higher than usual prostate dose escalation protocols or hypo-fractionated regimes are used. Further prospective clinical investigations on larger cohorts and more conformal radiation techniques will be necessary to define the clinical advantage of the biodegradable interstitial tissue separation device.

Women's acceptance of a double-balloon device as an additional method for inducing labour

ObjectiveA wide variety of pharmacological and mechanical methods (e.g. balloon devices) are available for inducing labour, but little information is available about the way in which women regard balloon devices. The aim of this study was to investigate women's acceptance of and satisfaction with the induction of labour by administration of oral misoprostol and the combination of that with a double-balloon device. Study designThe study included 122 women with term pregnancies who required induction of labour between August 2009 and November 2010. They all participated in a randomized controlled trial to test different ways of inducing labour and were randomly assigned either to a 'study group’ (with a combination of oral misoprostol and a double-balloon catheter) or a 'control group’ (with oral misoprostol alone). After childbirth, a standardized questionnaire was given to all of the women for them to complete before discharge. In addition to assessing the induction of labour and their level of satisfaction with regard to delivery, the birth experience was objectively evaluated using the German-language version of Salmon's Item List (SIL-Ger). For statistical analysis, the chi-squared test, Fisher's exact test, the binomial test, the t-test, or the Mann–Whitney U-test for independent samples were used as appropriate. A significance level of 5% was chosen. ResultsSeventy-eight questionnaires were included in the analysis. The women were not bothered either by the placement of the double-balloon device (P=0.017) or by the presence of the catheter (P=0.002). In comparison with the control group, women in the study group would consider their method in a subsequent pregnancy and would recommend it to others more often (P=0.040). The SIL-Ger score showed a positive birth experience in both groups, with a significantly better score in the study group (87.7±15.8 vs 79.3±17.3 in the control group; P=0.030). The multivariate analysis identified three factors influencing the SIL-Ger score: satisfaction with childbirth (P<0.001), involvement in decision-making after childbirth (P=0.041), and the method of labour induction (combination of oral misoprostol and double-balloon catheter vs oral misoprostol alone; P=0.005). ConclusionThe women were satisfied with the induction of labour using oral misoprostol and the combination of that with a double-balloon catheter. The double-balloon catheter was accepted by the women, and surprisingly was found to have a positive impact on the birth experience.

Accuracy of Transnasal Cannulation and Dilation of the Maxillary Ostium in Cadavers with Intact Uncinates

Transnasal cannulation of the natural ostium in patients with an intact uncinate process is complicated by the lack of direct visualization of the ostium. Accuracy of transnasal dilation of the maxillary ostium was evaluated for a malleable-tipped balloon device that was bent to specific angles for avoiding the fontanelle during cannulation. Transnasal cannulation and dilation of 42 cadaver maxillary sinus ostia was attempted by 6 surgeons including 3 with very limited clinical experience using the study device. All physicians received procedure training including the technique to shape the balloon device into the recommended 135° maxillary configuration. Tissue dissection was prohibited. Canine fossa trephination and transantral endoscopy were used to evaluate cannulation and dilation outcomes. Physician operators were blinded to transantral images and results were documented by two observers. Appropriate transnasal cannulation and dilation of natural maxillary sinus ostia occurred in 92.9% (39/42) of attempts. Two failures emanated from procedural deviations. In one deviation, the bend angle was changed to 90° and the device tip did not cannulate the ostium. In the second, the device was passed through a preexisting hole in the uncinate and cannulated the natural ostium. A third failure occurred when the device was passed through the fontanelle creating a false lumen. Using recommended procedural techniques and a malleable-tipped balloon device, newly trained and experienced physicians alike can perform uncinate-preserving transnasal cannulation and dilation of the maxillary ostium with a high rate of success.

Induction of labor using double balloon cervical device in women with previous cesarean section: Experience and review

Induction of labour remains one of the most challenging interventions in current obstetrics. Different pharmaceuticals have been used for cervical ripening such as prostaglandins; however they can lead to a number of potential inconvenient risks namely uterine tachysystole and pathological fetal cardiotocography (CTG). In cases of women with previous caesarean births, using prostaglandins would pose even higher risks such as uterine rupture and perinatal mortality. A mechanical method of cervical ripening could represent an alternative for these women. We report the use of the extra-amniotic double balloon cervical device (Cook’s device) for ripening of unfavourable cervix in seventeen women attempting vaginal birth after cesarean section (VBAC). Using Bishop scoring system to assess cervical dilatetion, position, consistency, fetal station and effacement, the unfavourable cervix is the cervix that scores less than 6. We review the relevant literature discussing this method of induction focusing on its effectiveness, simplicity, safety and efficacy, low cost and any associated serious side effects. Conclusion: Success was estimated to be over 50% with no serious life threatening maternal or fetal complications. We considered the process satisfactory and practical. We recommend larger studies to assess safety and efficacy of Cook’s device in vaginal birth after caesarean section before embarking on routine elective caesarean delivery. Objectives: To estimate success rate for vaginal delivery after previous caesarean section using cervical double balloon device (Cook’s device). Design: Three-year observational study. Setting: Maternity unit in district general hospital, UK. Population: Women who had one previous lower segment caesarean section and unfavourable cervix identified as having Bishop Score less than 6. Methods: Data were obtained from the birth registry over 3 years from January 2008 until December 2010. Main outcome: Measure successful vaginal delivery. Results: Out of 25 cases that had induction of labour with history of one previous lower segment caesarean section, 17 patients did fit in the inclusion criteria and were studied. 53% had a successful vaginal delivery while 47% had to have cesarean section either due to failure to progress or pathological cardiotocography. 82% required to have syntocinon infusion for augmentation as per local unit protocol. All newborn babies were in good condition and did not require admission to neonatal intensive care unit.

Double balloon device compared to oxytocin for induction of labour after previous caesarean section

Objective: To assess cervical changes, duration of oxytocin infusion, mode of delivery and complications after cervical ripening using a double balloon device in women with a previous caesarean section. Methods: Longitudinal study including 80 women with a previous caesarean section, no previous vaginal delivery and an unfavourable cervix (Bishop score

The evolution of the treatment of urinary stone disease.

The surgical management of urinary stone disease has developed over recent years; treatment options include ESWL, percutaneous nephrolithotomy and ureterorenoscopy (rigid or flexible). The 2013 edition [1] of the European Association of Urology Guidelines on Urolithiasis indicates that laparoscopic kidney stone surgery should be considered in the following cases: complex stone burden, failed previous ESWL and/or endourological procedures, anatomical abnormalities, morbid obesity, and nephrectomy in case of non–functioning kidney. The ureteropelvic junction (UPJ) obstruction is an anatomical abnormality defined by a blockage of urine flow from the kidney to the proximal ureter. We consider that in the case of UPJ obstruction with concomitant kidney stone, the laparoscopic pyeloplasty should be the treatment of choice. This type of treatment offers the necessary guarantees for the treatment of the UPJ obstrucion and allows us to combine endoscopic instruments to treat the associated secondary lithiasis with a stone free rate of 100% and a success of UPJ obstruction resolution near 95% [2]. No comparative studies have been done in this field, but it seems that laparoscopic pyeloplasty procedures have better outcomes in UPJ obstruction with concomitant lithiasis. Anterograde endopyelotomy with concomitant percutaneous stone removal has been performed with a success rate of 64% to 85% in different series [3] and ureteroscopic endopyelotomy or endoureterotomy with a ureteral balloon device has also been used with a success rate of 78% [3]. The choice between retroperitoneoscopic or transperitoneal approach in laparoscopic pyeloplasty is a never–ending debate. Equivalent success rates have been quoted in the literature for both approaches [4] but as Dr. Marcin Slojewski said in his editorial comment [5] surgeon preferences and experience remains the main determinant of choice. In our department, we are starting to treat selected cases of kidney stone disease by retroperitoneoscopic approach; the results in the first cases are promising and we hope to have enough experience in a few years to show our findings.

Treatment of massive irreparable rotator cuff tears through biodegradable subacromial InSpace Balloon

The massive irreparable tears of rotator cuff represents a debilitating condition for the patient as well as it is still an hard challenge to an orthopedic surgeon [1,2]. Treating these tears is an interesting and evolving issue due to the development of arthroscopic surgery and of the materials used for treatment. There are several surgical options for treating massive tears, among these the arthroscopic debridement and the implant of a reverse prosthesis [3]. Recently, the Biodegradable InSpace Balloon device has been put on the market, once implanted between the acromion and the proximal humeral epiphysis, this device guarantees significant pain reduction and range of motion (ROM) improvement in patients affected by massive rotator-cuff shoulder tears, as it restores the correct expanse of the pathologically reduced subacromial space. Primary end-points include: pain relief, improvement in the range of motion, activities of daily living, and enhancement of shoulder strength referring to the Constant Score [5] recorded at each follow-up visit.

Abstract 18248: Should We Refrain to Perform TAVI Procedures in Patients with a Mitral Regurgitation? Insights from the FRANCE 2 Registry

Background: The presence of mitral regurgitation (MR) is an independent predictor of mortality after conventional aortic valve replacement for aortic stenosis. The predictive value of pre-procedural MR on clinical outcome after TAVI is unknown. Methods: 3,195 consecutive patients were enrolled between January 2010 and October 2011 in 33 centres. MR was graded according to pre-procedural transthoracic echocardiography (TTE) as none/trivial (=0), mild (=1), moderate (=2), moderate-to-severe (=3), or severe (=4). The mean age was 82±7 years; 49% were female and mean logistic EuroSCORE was 21.9±14.3. Balloon (BE) and self-expendable (SE) devices were implanted in 66.9% and 33.1% of patients, respectively. Approaches were transarterial (transfemoral: 74.6%; subclavian: 5.8%), transapical (17.8%), and transaortic (1.8%). Results: Pre-procedural TTE showed no MR in 32% of cases, a grade 1 MR in 46% of cases, a grade 2 MR in 20% of cases and a grade 3-4 in 2% of cases. Procedural success rate was 96.9%. Actuarial 1 year mortality was 19.5%. By univariate analysis, pre-procedural MR grade≥2, MR Grade=1 and MR Grade=0 were associated with a 1 year mortality rate of 24.0%, 20.1% and 15.8%, respectively (p=0.002). By multivariate analysis, 4 independent baseline characteristics were associated with preprocedural MR: a higer Logistic EuroSCORE (p=0.0001), a lower ejection fraction (p=0.0002), a higher NYHA class (p=0.0007), and female gender (p=0.001). By multivariate Cox analysis, independent predictors of one-year mortality were: logistic EuroSCORE (p=0.0001), NYHA class (p=0.0001) and transapical approach (p=0.0005). The presence of preprocedural MR was not significantly associated with 1-year mortality (p=0.31). Results did not differ when analyses were restricted only to BE or only to SE devices. Conclusion: A mild (grade1) or a moderate (grade 2) MR preprocedural is associated with a higher 1-year mortality after TAVI. However, since preprocedural MR is associated with a higher NYHA class or a higher logistic Euroscore, pre-procedural MR is not an independent predictor of mortality. These findings suggest that, in itself, the presence of a mild or a moderate MR should not refrain from performing TAVI and should not impact the type of valve to be used

TAVI with Balloon and Self-expandable Devices: Results from the Milan Registry

TAVI with Balloon and Self-expandable Devices: Results from the Milan Registry

Are Sizing Balloons Necessary During Repeat Radiofrequency Ablation Using the 360 Degree Treatment Balloon Device?

Are Sizing Balloons Necessary During Repeat Radiofrequency Ablation Using the 360 Degree Treatment Balloon Device?

Initial Experience of a Novel Through-the-Scope Balloon Device to Achieve Deep Intubation of the Ileum in Known or Suspected Crohnʼs Disease

Initial Experience of a Novel Through-the-Scope Balloon Device to Achieve Deep Intubation of the Ileum in Known or Suspected Crohnʼs Disease

O157 EFFICACY OF A SECOND GENERATION THERMAL BALLOON DEVICE (THERMABLATE) FOR ENDOMETRIAL ABLATION IN THE TREATMENT OF ANEMIA INDUCED BY MENO/METRORRHAGIA

International Journal of Gynecology & ObstetricsVolume 119, Issue S3 p. S316-S316 Free communication (oral) presentations O157 EFFICACY OF A SECOND GENERATION THERMAL BALLOON DEVICE (THERMABLATE) FOR ENDOMETRIAL ABLATION IN THE TREATMENT OF ANEMIA INDUCED BY MENO/METRORRHAGIA A. D'Afiero, A. D'AfieroSearch for more papers by this authorG.A. Tommaselli, G.A. TommaselliSearch for more papers by this authorP. Affinito, P. AffinitoSearch for more papers by this authorF. Forleo, F. ForleoSearch for more papers by this authorD. Stanco, D. StancoSearch for more papers by this author A. D'Afiero, A. D'AfieroSearch for more papers by this authorG.A. Tommaselli, G.A. TommaselliSearch for more papers by this authorP. Affinito, P. AffinitoSearch for more papers by this authorF. Forleo, F. ForleoSearch for more papers by this authorD. Stanco, D. StancoSearch for more papers by this author First published: 22 October 2012 https://doi.org/10.1016/S0020-7292(12)60587-6Citations: 1AboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat No abstract is available for this article.Citing Literature Volume119, IssueS3Abstracts of XX FIGO World Congress of Gynecology and ObstetricsOctober 2012Pages S316-S316 RelatedInformation

The CROES Percutaneous Nephrolithotomy Global Study: The Influence of Body Mass Index on Outcome

In addition to more commonly forming stones, obese patients present a number of challenges when undergoing percutaneous nephrolithotomy. We evaluated percutaneous nephrolithotomy outcomes in 3,709 patients stratified by body mass index. A prospective database administered by CROES (Clinical Research Office of the Endourological Society) captured data on 5,803 patients treated with percutaneous nephrolithotomy between November 2007 and December 2009. Patients with known solitary kidney, previous percutaneous nephrolithotomy and congenital abnormalities were excluded from analysis. For statistical analysis patients were categorized as normal weight--body mass index 18.5 to 25 kg/m(2), overweight--25 to 30, obese--30 to 40 and super obese--greater than 40. During the study period 5,803 patients underwent percutaneous nephrolithotomy, of whom 3,709 met the inclusion criteria. As expected, obesity was associated with significantly higher rates of comorbid conditions and anticoagulant use (p < 0.001). Operative time was significantly longer in obese patients and use of a balloon device for tract dilation was more common (each p < 0.001). The stone-free rate decreased with obesity (p = 0.009), corresponding to a significantly higher re-treatment rate in this group (p < 0.001). No difference was seen in length of stay or the transfusion rate. No significant difference was seen in the overall complication rate among the 4 groups (p = 0.707). Percutaneous nephrolithotomy may be done safely in obese patients, although with a longer operative time, an inferior stone-free rate and a higher re-intervention rate.

Su1462 Challenging Colonoscopy: Safety and Effectiveness of a New ON-Demand Balloon Device for Facilitating Complete Colonoscopy in Challenging Patient Anatomy

Anatomy-related factors such as morbid obesity, redundant colon and post-surgery adhesions, often increase colonoscopy procedure time and associated risk, and limit completion yield. A new balloon device (NaviAid™ ABC; Smart Medical Systems Ltd.), applicable upon need in the course of examination, facilitates complete colonoscopy and reduced pushing-forces in challenging patient anatomy. During colonoscopy and upon need, the ABC catheter is advanced through the colonoscope's instrument channel and beyond the challenging segment or tight curve in the colon, whereat the balloon is inflated and anchored.