Dual Balloon Research Articles

Embolization of posterior fossa meningiomas supplied with meningohypophyseal trunk by using n-BCA and dual balloon protection.

Efficacy of tumor embolization for posterior fossa meningioma is controversial due to the lack of adequate embolization for dangerous feeders. Of these, a meningohypophyseal trunk (MHT) has high therapeutic value despite the high risks associated with embolization. To analyze the utility of preoperative MHT embolization for posterior fossa meningiomas using n-BCA with dual balloon protection, a single center retrospective record review was performed on eight consecutive patients who underwent preoperative tumor embolization via the MHT for posterior fossa meningiomas between 2020 and 2024. All patients successfully embolized the MHT using n-BCA. Complete obliteration was achieved in five cases, which is related to the tentorial artery alone as the feeding vessel. None of the patients had cerebral infarction associated with distal embolization. One patient experienced worsening of preoperatively observed abducens nerve palsy due to cranial nerve ischemia. Gross total resection was achieved in seven of eight cases. The mean estimated blood loss during surgical resection was 186 mL (range, 39-392 mL). The mean operative time was 431 min (range, 317-767 min). The MHT embolization of posterior fossa meningiomas by using n-BCA is technically feasible with a high success rate and an acceptable complication rate. MHT=meningohypophyseal trunk; ILT=inferolateral trunk; CPA=Cerebellopontine angle; BGC=balloon guide catheter; PVA=polyvinyl alcohol; GTR=Gross Total Resection; CN=Cranial nerve.

Multicenter prospective evaluation of an overtube endoluminal interventional platform for colorectal polypectomy

Background and study aims Endoscopic removal of complex colorectal polyps (≥ 2 cm) can be technically challenging. A dual balloon endoluminal overtube platform (DBEP) was developed to facilitate colonoscopic polypectomy. The study purpose was to evaluate clinical outcomes with the DBEP for complex polypectomy. Patients and methods This was an observational, prospective, multicenter Institutional Review Board-approved study. Between January 2018 and December 2020, safety and performance data were collected intra-procedurally and at 1 month post-procedure in patients undergoing intervention with the DBEP at three US centers. The primary endpoint was device safety and technical success of the procedure. Secondary endpoints included navigation time, total procedure time, and user feedback assessment post-procedure. Results A total of 162 patients underwent colonoscopy with the DBEP. Of these, 144 (89 %) underwent 156 interventions successfully with DBEP (44.5 % endoscopic mucosal resection, 53.2 % hybrid endoscopic submucosal dissection (ESD)/ESD, 1.3 % other). In 13 patients (8 %), device challenges contributed to unsuccessful intervention. One mild device-related adverse event (AE) occurred. Procedural AE rate was 8.3 %. Median lesion size was 2.6 cm [range 0.5-12]. The investigators felt that navigating the device was easy/somewhat easy in 78.5 % of successful cases. Median total procedure time was 69 minutes [range, 19-213], median navigation time to lesion was 8 minutes [range, 1-80], And median polypectomy time was 33.5 minutes [range, 2-143]. Conclusions Endoscopic colon polyp resection with the DBEP was safe with a high technical success rate. The DBEP has the potential to provide enhanced scope stability and visualization, traction, and a conduit for scope exchange. Further prospective randomized studies are warranted.

Intra-arterial gemcitabine vs IV gemcitabine PK substudy in patients with locally advanced pancreatic cancer.

728 Background: Localized dual-balloon-mediated, intra-arterial delivery of Gemcitabine (IAG) directly into tumors/tissue can lead to higher local drug potency1. Furthermore, IAG may lead to decreased systemic drug concentration and associated side effects. In patients with Locally Advanced Pancreatic Cancer (LAPC), this approach is currently being tested in a contemporary Phase III clinical trial, TIGeR-PaC. Herein we report the results of a 10-patient PK analysis sub-study within TIGeR-PaC. Methods: We analyzed a total of 10 subjects from 5 sites who received intra-arterial gemcitabine with the RenovoCath dual balloon catheter at 1000mg/m2 over 20 minutes. The target treatment artery was either the celiac axis (n=5) or the superior mesenteric artery (n=5). Samples were drawn at T = -5, 10, 15, 20, 30, 40, 60, and 90 minutes from the onset of infusion. At each timepoint, we collected 2mL of blood in heparinized tubing containing 25 mcg/mL of tetrahydrouridine. The blood samples were then centrifuged collect, freeze, and ship the plasma to a reference lab to perform a gemcitabine assay. The PK parameters for a single dose was estimated for Cmax, AUC, clearance, and distribution volume based on the terminal phase. These values are compared to historical data for intravenous gemcitabine (IVG) infusion at 1000mg/m2 over 30 minutes2. Results: At this time, data has been analyzed for 4 of 8 collected samples. We expect to complete collection and analysis of all 10 samples by November of 2022. We show results available so far; historical values for IVG are given as a reference point. The results suggest that IAG is associated with decreased systemic exposure of gemcitabine compared to IVG. Conclusions: Localized dual-balloon-mediated, intra-arterial delivery of gemcitabine can lead to decreased systemic levels of gemcitabine. This approach increased local potency and may be beneficial in decreasing gemcitabine-related systemic side effects. 1. Farsad K, et al. 04:21 PM Abstract No. 392 . J Vasc Intervent Radiol 2019;30(3):S172. doi:10.1016/j.jvir.2018.12.467. 2. Chow ECY, Zirkelbach JF. Clinical Pharmacology and Biopharmaceutics Review(s) {209604Orig1s000}. FDA: Center for Drug Evaluation and Research. Clinical trial information: NCT03257033 . [Table: see text]

Dual guidewire balloon for antegrade fenestration re-entry: A welcome addition to the CTO operators' armamentarium.

Dual guidewire balloon for antegrade fenestration re-entry: A welcome addition to the CTO operators' armamentarium.

Dual Balloon Catheter: A Novel Laparoscopic Common Bile Duct Exploration Device.

Introduction: Choledocholithiasis is a disease process that can be managed by laparoscopic common bile duct exploration at the time of cholecystectomy. However, it can be negatively perceived by surgeons as lengthening procedure time and adding technical complexity. Materials and Methods: We have created a dual balloon biliary intervention catheter designed to make common duct exploration efficient, simple, and safe. The device consists of two balloons, one compliant and one noncompliant, to perform initial cholangiography, dilate the sphincter, and occlude the proximal duct for distal power flushing of stones. The catheter design facilitates a stepwise, over the wire progression of interventions with a singular device. Results: The catheter has been successfully deployed in a porcine feasibility model and the dual balloon concepts reduced to practice using currently available devices. Conclusion: Laparoscopic common bile duct exploration is a safe and effective way to treat choledocolithiasis. The Dual Balloon Catheter is a novel device that allows for duct occlusion for cholangiogram and power flushing in conjunction with duct and sphincter dilation.

The Vascular Architecture of Cavernous Sinus Dural Arteriovenous Fistula and Its Impact on Endovascular Treatment Approach Selection and Outcome

A cavernous sinus (CS) dural arteriovenous fistula (DAVF) is a form of abnormal arteriovenous communication that can be treated with endovascular embolization. Establishing an optimal access route should be based on vascular architecture. We reviewed 64 patients with CS-DAVF who underwent endovascular embolization and report the endovascular treatment approach selection and outcome. Clinical data were obtained from 64 patients with CS-DAVF who had been surgically treated at the authors' hospital between 2009 and 2022. Patients' medical records, imaging data, and follow-up outcomes were retrospectively analyzed. All 64 patients (15 male, 49 female; mean age, 50 years) underwent CS-DAVF embolization. The most common symptoms were exophthalmos (39.1%), chemosis (35.9%), and headache (28.1%). On digital subtraction angiography images, 34.4% of the DAVFs were unilateral, and 82.8% were fed by both the external carotid artery and internal carotid artery. Of the patients' inferior petrosal sinuses (IPSs), 54.7% were nonopacified. The most common intravascular approaches included trans-IPS (37.5%) and trans-artery (28.1%) approaches. More than half of the CS-DAVFs were embolized by both coils and Onyx (62.5%). A total of 85.9% of the fistulas were completely embolized, and the follow-up rate was 76.6%. The modified Rankin Scale score was 0.9 ± 1.0. The vascular architecture of CS-DAVF is closely related to endovascular treatment approach selection and outcome. Combined with the modified IPS recanalization technique, the trans-IPS approach is the safest and most effective approach. Dual microcatheter and balloon assistance techniques ensure the safety and completeness of embolization.

Dual guidewire balloon antegrade fenestration and re-entry technique for coronary chronic total occlusions percutaneous coronary interventions.

To describe the experience of coronary chronic total occlusions (CTOs) percutaneous coronary interventions (PCI) using antegrade fenestration and re-entry (AFR) technique with a dedicated dual guidewire balloon (DGB). Antegrade dissection and re-entry (ADR) techniques has been emphasized in recent worldwide CTO consensus documents. We investigated the feasibility and safety of DGB as a dedicated device to perform guidewire-based AFR. Fourteen consecutive patients with complex CTO (J-CTO score: 3.1 ± 0.9) underwent DGB-AFR in the years 2020-2021. DGB-AFR consists in advancing the DGB over a guidewire that reached the vessel distal to the CTO in an extra plaque fashion, inflating/deflating the DGB to create fenestration between subintimal space and the true lumen and advancing a proximal re-entry guidewire through fenestration in the true lumen. DGB-AFR alone was successful in 10 of 14 (71%) cases, a rescue wire-based ADR was needed in two cases for re-entry into the true lumen with a total success rate in 12 of 14 (86%) cases. Among all DGB-AFR cases, four (28%) were performed as a first-line strategy while the remaining 10 (71%) cases were performed as a bail-out strategy after failure of other antegrade crossings for 30 min of procedural time. No DGB-related complications were observed. DGB-AFR is a user-friendly reliable strategy for the treatment of many CTO lesions. It can be used as bail-out after failure of conventional antegrade wiring techniques, achieving high procedural success rate and low occurrence of procedural adverse events.

Subintimal Crossing of Chronic Total Occlusions in Peripheral Arteries With a Dual Guidewire Balloon Catheter: The PRAESTO Study

Purpose: The purpose of this study was to evaluate the safety and efficacy of antegrade fenestration re-entry (AFR) using a dual guidewire angioplasty balloon for chronic total occlusion (CTO) in patients with peripheral artery disease (PAD). Material and methods: This is a retrospective score matching analysis study comparing a study cohort composed of PAD patients with CTO treated with AFR subintimal recanalization using a dual guidewire angioplasty balloon and a matched control group, selected on baseline cardiovascular risk factor and lesions characteristics, treated with a conventional subintimal recanalization. Procedure outcomes include procedural success, successful subintimal re-entry, need for distal puncture, procedural time, fluoroscopy time, and dose area product. Clinical variables, including primary patency, freedom from amputation, freedom from re-interventions, and freedom from death, were used to compare the study groups. Results: Thirty patients in the study group were compared with 60 patients in the matched control group (mean age, male). A significant higher subintimal re-entry success (100% vs 76.7% in control group, p=0.004) and lower need of distal tibial punction (0 vs 14 [23.3%] patients in control group, p=0.004) were observed in the study group. A surgical conversion to bypass was needed in 5 patients in the control group. Shorter procedural and fluoroscopy time were observed in the study group (41.1±10.8 minutes vs 146.6±62. and 16.7±3.5 minutes vs 34.3±14.2 minutes in control group respectively, p<0.001 and p<0.001). Lower DAP were observed in the study group (914.1±309.9 µGym² vs 2026.5±845.7 µGym² in control group p<0.001). No significant difference were observed in terms of primary patency, mortality, amputation, and freedom from re-intervention. Conclusion: AFR using the Presto dual guidewire balloon is a step forward for crossing CTO which allows a simplified and quick treatment of BTK and ATK lesions compared with conventional approaches without increase of procedural risk and maintaining good clinical outcomes.

A novel dual balloon rectal catheter for use in the postoperative assessment of low rectal anastomoses following low anterior resection

Following low anterior resection (LAR) of the colon, an image-guided assessment of the anastomosis for leak is typically performed using an enema via a rectal catheter, whether by CT or fluoroscopy. However, there is potential for poor assessment due to inappropriate catheter positioning as well as potential risk that the anastomosis becomes compromised by the balloon inflation. This article discusses the adaptation of a novel double-balloon catheter (originally designed by a member of our institution for use in pediatric intussusception reduction) for assessment of low rectal anastomoses. The goal of this technical note is to demonstrate our experience with this catheter, primarily through example cases, and explain its potential for optimizing colon distension, minimizing improper catheter placement, and potentially reducing the risk of iatrogenic anastomosis disruption.

Preclinical testing of a novel pericardial left ventricular assist device (PALVAD)

Abstract Funding Acknowledgements Type of funding sources: Public grant(s) – National budget only. Main funding source(s): British Heart Foundation Background Cardiogenic shock (CS) complicates 8% of acute myocardial infarctions and has a short-term mortality approaching 50%. Traditional mechanical circulatory support (MCS) have significant adverse event profiles related to their position within the circulation. PALVAD is an extra circulatory MCS designed to be implanted percutaneously. The dual balloon system provides cardiac support whilst sitting in the space between the pericardium and left ventricular (LV) free wall. The actuator (ACT) balloon augments CO through ECG gated LV systolic compression and the positioning balloon sits against the pericardium dissipating this force. Methodology Non-recovery experiments were conducted in eleven 40k-60g pigs. A percutaneous coronary balloon occlusion model was initially used (n = 3) following which an Esmolol infusion model (n = 8) was used due to increased stability when titrating for a low cardiac output state . A Millar catheter was placed in the LV for simultaneous pressure and volume measurements and a Transonic flow probe was placed around the internal carotid. The device was inserted percutaneously and operated for alternating on/off periods. The device was inserted into a saline perfused cadaver following which CT and MRI imaging was undertaken. CT images were reconstructed three dimensionally and analysed. Results PAL-VAD had a significant impact across all parameters with a mean increase of 42% ± 16.1 in CO, 42% ± 17.3 in stroke volume, 20% ± 15.5 in pressure and a 30% ± 18.5 in flow and a mean device actuation of 48mins. Cadaveric imaging confirmed appropriate device dimensions for human anatomy and a 32% reduction in LV volume was seen with ACT balloon inflation. Conclusions PALVAD performance in during a low CO state is promising. Recovery experiments, including histology assessment, are planned to further evaluate safety and efficacy with longer-term use. % Increase with PALVAD Parameter% IncreaseCardiac Output42Stroke Volume42Pressure20Flow30Abstract Figure.

Lack of efficacy of dual intragastric balloon therapy on weight loss and patient dissatisfaction

BackgroundDual intragastric balloon (DIGB) therapy is a non-surgical, restrictive method of weight loss. We evaluated weight loss and patient satisfaction after DIGB removal. MethodsBetween 2016 and 2019, 35 patients had DIGB therapy. A retrospective review of weight loss at balloon removal and follow-up, adverse events during DIGB therapy, and patient satisfaction was performed. ResultsAt follow-up after balloon removal (22.3 ± 10.5 months), mean percent excess weight loss (%EWL) was significantly decreased compared to %EWL at removal (4.7 ± 42.7% vs 32.4 ± 38.8%, p = .001). Weight regain occurred in 22/31 (71%) patients. Adverse events during DIGB therapy included: nausea, abdominal pain, reflux, pancreatitis, and gastric outlet obstruction. Twenty-five (71.4%) patients completed a satisfaction questionnaire. Only 3/25 (12%) patients were satisfied, and 92% would not choose DIGB for weight loss. ConclusionWeight loss achieved from DIGB on average was not maintained after balloon removal. Most patients were not satisfied and would not choose DIGB again.

Pericardial Left Ventricular Assist Device (PALVAD) development via large animal and cadaveric models

Abstract Background Cardiogenic shock complicates around 8% of acute myocardial infarctions with a significant short term mortality of 35–50%. Traditional mechanical circulatory support can improve cardiac output (CO) however they have significant adverse event profiles related to their position within the circulation, including but not limited to infection, stroke and embolism. PALVAD is an extra circulatory left ventricular assist device, designed to be implanted percutaneously., It provides cardiac support whilst sitting outside the circulatory system in the space between the pericardium and left ventricular (LV) free wall. The dual balloon system connects to an external pumping system via a drive line. The actuator balloon augments CO through ECG gated LV systolic compression and the positioning balloon sits against the pericardial surface dissipating this force across a large surface. Purpose Assess device efficacy in a low CO state in a non-recovery porcine model. Understand device interactions with the left ventricle and pericardium in a cadaveric model. Methodology Non-recovery porcine model experiments were conducted in three 40k-50g pigs at a large animal catheterisation facility. An Esmolol infusion was titrated to create a low output state. A Millar catheter was placed in the LV for simultaneous pressure and volume measurements and a Transonic flow probe was placed around the internal carotid for flow measurements. The device was inserted percutaneously and operated for a total of 4.7 hrs. For cadaveric experiments the device was inserted into a Thiel embalmed saline perfused cadaver following which detailed CT and MRI imaging was undertaken. Results When target reduction in cardiac output was met PALVAD increased systolic pressure by 34%, stroke volume by 54%, CO by 53% and flow by 53%. There was no macroscopic evidence of epicardial or pericardial damage. Cadaveric imaging further informed optimal positioning of the device in relation to the LV free wall. Conclusions PALVAD performance during low CO state in non-recovery porcine experiments is promising. Further recovery experiments, including histology assessment, are planed to evaluate safety and efficacy with longer term use to guide optimisation towards the eventual aim of a first-in-man trial. Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): British Heart Foundation Translational Research Grant

Retrograde three-dimensional rotational angiography: A novel method for the detection of plaque protrusion during carotid artery stenting under continuous distal balloon protection.

To prevent ischemic complications during carotid artery stenting, accurate detection of plaque protrusion and appropriate additional treatment are essential. Here, we introduce a novel method for the detection of plaque protrusion under distal balloon protection using three-dimensional rotation angiography-"retrograde 3DRA." We evaluated the safety and efficacy of this method. We retrospectively analyzed 28 consecutive carotid artery stenting procedures under distal balloon protection at our hospital between July 2017 and August 2019. The first line of protection was dual balloon protection (proximal and distal balloon). After stent deployment, balloon dilatation, and subsequent blood aspiration, 3DRA was performed with the injection of diluted contrast medium from the aspiration catheter positioned just proximal to the distal protection balloon. The stent lumen was analyzed by obtaining the reconstruction maximum intensity projection image. Among the 28 cases, all cases could be assessed for in-stent plaque protrusion using "retrograde 3DRA." We were able to evaluate the stent lumen clearly. There were three cases (10.7%) in which plaque protrusion could be confirmed. Since additional balloon dilatation was performed for all protrusion cases under continuing balloon protection, no ischemic complications occurred. Retrograde 3DRA could be safe and useful for the detection of plaque protrusions and to avoid ischemic complication for tolerable cases of internal carotid artery transient balloon protection.

Curative therapy for aged patients with localized bladder cancer

Abstract Purpose We have tested the treatment outcome in patients with localized bladder cancer who underwent bladder preserving multimodal treatment with curative intent stratified by patient age. Methods Totally 597 patients were enrolled in the present analyses. Our tetra modal therapy consisted of complete resection of the tumor, chemotherapy and radiation therapy followed by dual balloon occluded intra-arterial infusion of chemotherapeutics. We included all cases from August 2009 until December 2015 with at least 6 months of follow up. We evaluated oncologic outcomes based on T stage, grade, lymph node status, age, sex, and presence of hydronephrosis. All data was analyzed using SPSS ver24. Results Patients were stratified into 4 groups by age: group1 (aged younger than 60), group2 (aged 60 through 69), group3 (aged 70 through 79), and group4 (aged 80 or older). There were no differences in gender, T stage, and N stage. Recurrences in between 4 groups were 15 (12.2%) for group1, 45 (20.9%) for group2, 41 (21.1%) for group3, and 16 (24.6%) for group4 showing no significant differences (p = 0.119). Pathological evaluation straight after the therapy also showed no differences in 4 groups (p = 0.326). There was no significant differences in cancer specific deaths (p = 0.274), while overall survival rate showed significant better survival in younger age group (p = 0.0222). Estimated mean survival for group1 was 73.5months (68.1 to 78.9), 72.6months (67.4 to 77.9) in group2 (p = 0.055 v.s. group1), 73.0months (67.1 to 79.0) in group3 (p = 0.048 v.s. group1), 63.1months (54.1 - 72.0)in group4 (p = 0.035 v.s. group1), showing the preferable survival in youngest age group, at the same time, suggesting competitive treatment success in any age group aged 60 or older. Conclusion Our tetra-modal bladder preserving treatment works regardless of the patients’ age at treatment initiation.

Distal Radial and Transpedal Access for Iliac Artery Chronic Total Occlusion Recanalisation using the Rendezvous Technique

Distal radial artery access with combination of the transpedal access has not been published in the literature for iliac artery chronic total artery occlusion (CTO) recanalisation. A 70-years-old male patient with critical limb ischaemia was presented for iliac artery CTO recanalisation. The distal radial artery was punctured by ultrasonography guidance and the anterograde recanalisation was started from radial artery access, but due to the failed reentry the retrograde recanalisation was done from transpedal access and the retrograde reentry was performed with Rendezvous-technique using dual balloon inflations. Iliac artery stent implantation was done from transpedal access using 6F slender sheath with the good angiography result.

Comorbidity Remission Following Intragastric Dual Balloon Placement.

The intragastric dual balloon was FDA approved in 2015 for the treatment of obesity. The objective of this study was to report the weight loss, comorbidity remission, and biochemical improvements experienced by 28 patients following intragastric dual balloon placement at a single institution between September 2015 and June 2017. Demographic data were collected preoperatively. Anthropometric, clinical, and biochemical data were collected preoperatively and 3 and 6months postoperatively. Two patients were lost to data follow-up. Participants experienced significant improvements in blood pressure and lipid profiles, in addition to substantial weight loss 6months after balloon insertion. The results of this study underscore the promise of the intragastric dual balloon as an efficacious intervention for weight loss and comorbidity remission in patients with early-stage obesity.

Real-World Safety and Efficacy of Fluid-Filled Dual Intragastric Balloon for Weight Loss

Reshape Duo is a saline-filled dual, integrated intragastric balloon (IGB) approved by the Food and Drug Administration for weight loss in patients with obesity. In a prospective, randomized trial, obese patients who received the balloon had significantly greater percent excess weight loss (%EWL) compared with patients treated with diet and exercise alone. However, there are limited data on the real-world efficacy of the Reshape balloon. We performed a retrospective study of data collected from 2 academic centers and 5 private practices in which all patients paid for the IGB and follow-up visits out of pocket. The IGB wasremoved after 6 months. We collected data (demographic, medical, and laboratory) from202 adults (mean age 47.8 ± 10.8 years; 83% female) with a baseline mean body mass index of 36.8+ 8.4 kg/m2 who had IGB insertion for weight loss therapy, along with counselling on lifestyle modifications focused on diet and exercise. Primary outcomes were percent total body weight loss (%TBWL) and %EWL at 1, 3, 6, 9, and 12 months after the procedure. Mean %TBWL at 1, 3, 6, 9 and 12 months was 4.8 ± 2.4%, 8.8 ± 4.3%, 11.4 ± 6.7%, 13.3 ± 7.8%, and 14.7 ± 11.8%, respectively. Data were available from 101 patients at 6 months and 12 patients at 12 months; 60.4% of patients achieved more than 10% TBWL and 55.4% had more than 25% EWL. Seventeen patients (8.4%) had esophageal tears during balloon insertion, with no intervention required. Thirteen patients (6.4%) had their IGB removed before the end of the 6-month treatment period. Nausea, vomiting, and abdominal pain were the most common adverse effects, occurring in 149 (73.8%), 99 (49%), and 51 (25.2%) patients. In one patient, the IGB migrated distally leading to small intestinal obstruction requiring surgical removal. In a retrospective analysis of real-world patients who received the Reshape Duo IGB, we found it to be a safe and efficacious endoscopic method for producing weight loss, with most patients achieving greater than 10% TBWL at 6 months.

Clinical Studies of Reshaped Integrated Dual Balloon System in Obese Patients

Clinical Studies of Reshaped Integrated Dual Balloon System in Obese Patients

Abstract 4762: New device for radiation delivery in breast cancer patients - double balloon applicator for optimal dose distribution

Abstract Currently available applicators for delivery of accelerated partial breast irradiation using a high dose afterloader, have treatment catheters close to the center of the balloon in fixed positions, restricting one’s ability to modify the dose to critical organs. Recently we developed a novel, dual balloon brachytherapy applicator using which one could optimize radiation dose by shaping the resection cavity with an outer balloon and allowing an inner balloon to selectively position the treatment catheters away from the central axis of the balloon based on cavity size. The Double Balloon Breast Brachytherapy applicator offers a unique design with adjustable treatment catheters, allowing for both optimized dose delivery and conformal avoidance of critical structures. This applicator is a single entry (1 cm incision), multi-channel high dose rate afterloader (HDR) accessory device. The treatment catheters can be expanded to an optimal location greater than or equal to 50% of the outer balloon diameter(&amp;gt; 1 cm diameter) - thereby optimizing dose delivery to the patient. The Conformal Double Balloon Breast Brachytherapy Device has the ability to optimize either conformality or homogeneity by allowing expansion of an inner polyurethane balloon to selectively position multiple treatment catheters significantly away from the central axis of an expanded outer polyurethane balloon. A model study of the Double Balloon Breast Brachytherapy Device was performed with a wide range of volumes of the lumpectomy cavity. Each case is scanned in a CT scanner and the data transported to a treatment planning system. Dosimetric parameters such as dose delivered to treatment site, different organs such as skin, ribs, etc are evaluated and compared against existing breast brachytherapy applicator devices. Both ultrasound and CT images clearly indicate that the quality of the Double Balloon Device images are comparable to other commercial devices. All catheters are distinguishable and can be reconstructed for treatment planning, and the balloon volume can be clearly delineated. Planning Treatment Volume (PTV) based on balloon volume can be easily generated and optimized dosimetry performed. Initial patient studies also indicate that using the double balloon applicator optimized dosimetry can be obtained thereby reducing the dose to critical structures such as skin and rib while maintaining the dose to the target. Citation Format: Manny R. Subramanian, Mike Cutrer, Rohit Mehta. New device for radiation delivery in breast cancer patients - double balloon applicator for optimal dose distribution [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2017; 2017 Apr 1-5; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2017;77(13 Suppl):Abstract nr 4762. doi:10.1158/1538-7445.AM2017-4762

The role of endoscopic therapy in obesity management: intragastric balloons and aspiration therapy.

Weight management is increasingly incorporating endoscopic bariatric therapy (EBT). As the global burden of obesity and its comorbidities has increased, it is evident that novel therapeutic approaches will be necessary to address the obesity epidemic. EBTs offer greater efficacy than diet and lifestyle modification and lower invasiveness than bariatric surgery. The US Food and Drug Administration has approved two intragastric balloons and aspiration therapy for the treatment of obesity: Apollo Orbera is indicated for the treatment of Class I and Class II obesity, Re Shape Integrated Dual Balloon system is indicated for the same range with a comorbidity, and Aspire Bariatrics AspireAssist is approved for patients with a body mass index of 35–55 kg/m2. These devices have proven safe and effective in clinical trials and are gaining commercial acceptance in the USA; the Orbera has been used extensively outside the USA for over 20 years. These devices will need to be delivered in the context of a multidisciplinary weight loss program, integrating comprehensive care of obesity. Patient selection is important, and ensuring appropriate patient expectations and understanding of alternatives such as pharmacologic therapy and surgery is essential. With several EBTs on the horizon, patients with obesity will have an even broader array of safe and effective options for weight management in the future.