A BOSTON SCIENTIFIC PUBLICATION MAY/JUNE 2014 • ISSUE 1

ENHANCING PATIENT OUTCOMES. DELIVERING TOTAL VALUE.™

› Education materials focus on the patient.

New Slimline Handle

The Making of a More Ergonomic Handle

™ Expect Slimline (SL) Needle Original Handle addresses physician preference. A Message From Dave Pierce

The idea of green means different things to different For example, we are taking every opportunity to look people. For some, it’s about energy – alternatives, at packaging improvements and what can be done to footprint and conservation. For others, it’s about help reduce waste, use more recyclable materials, waste management and recycling. There are take up less shelf space, and improve operational many definitions. and procedural efficiencies (p. 9).

Through our association with Practice Greenhealth, Tackling the challenges of sustainability is much like we’ve learned that many health care facilities have figuring out the changing health care landscape – it a fairly broad definition of green – one that includes encompasses many things and there is no one right managing waste, approach, no one right delivery-of-care model. energy efficiency, Customers like Kaiser and Geisinger Health (Read health risks and about Geisinger Health System in the October 2012 safety. Green issue of ACCESS magazine) and others are taking initiatives are not action. They see the future – the challenges, the solely motivated by opportunities and the possibilities – and they are cost or compliance making changes to be successful in the evolving health but by the potential care landscape. We are proud to be working with impact to patients, such customers and believe we have an important employees and role to play in helping them achieve their goals. the community. Although the phrase “health care reform” is very Employees at Boston Kaiser Permanente, headquartered in Oakland, much associated with the U.S., our customers around Scientific’s Costa Rica California, is a great example. Through its the world face similar cost, quality and delivery-of- facility planted 250 trees on the property as part Environmentally Preferred Purchasing program, care challenges. Physician education to advance GI of a program designed Kaiser has reduced waste by approximately 2,400 is a key issue in many regions. That’s to help reduce CO2. tons, saved 87,000,000 kWh, switched to using why we continue to focus our efforts in this area and dozens of chemically safer products at its campuses work to create region-specific training. Read about as well as made a number of improvements in its a recent preceptorship held at St. Joseph’s Hospital in supply chain.* Kudos to Kaiser for its leadership and Marseille, France (p. 6), and our new endoscopy helping move the industry in this direction. training offerings at Boston Scientific’s Institute for Advancing Science in Paris (p. 7). We too are addressing sustainability. We are incorporating LEED standards into the construction Also in this issue, read about our Expect™ Slimline of new buildings and modification of existing (SL) Needle – a version of our EUS needle with a facilities. We’ve achieved ISO14001 certification at new handle to accommodate physician preference. all 14 of our major manufacturing and distribution Early feedback from physicians is impressive. See facilities worldwide. We are working to find ways to what they have to say and how their feedback made help our customers achieve their sustainability goals. a difference (p. 2).

Dave Pierce Senior Vice President, Boston Scientific President, Endoscopy Division

*Source: “Rethinking Environmentally Preferred Purchasing: A case Study in Implementation at Kaiser Permanente,” Feb. 4, 2014, V. Lochner, Practice Greenhealth website (www.practicgreenhealth.org). BOSTON SCIENTIFIC NEWS 1

access

Clip Device Clip Snare PLUS Rotatable

™ Direct Direct ™ ® ™ Retrieval Device and and Device Retrieval Captivator TWISTER News and New Devices New and News SpyGlass Resolution An Interview with Stewart, Maria Director & Economics of Health Reimbursement Update on Gurukul Endoscopy Boston Scientific – Initiatives Green Making a Difference Initiative the Gap Close Patient Improve to Works Access and Education to Care Visualization System 8 8 9 9 21 22 17-20 15-16

Colorectal cancer affects an estimated 1 in 20 Americans. WHAT’S YOUR LEVEL OF RISK? Take the Colorectal Cancer Risk Assessment Quiz to find out.

Colon Cancer Risk Assessment

Stents ™ Slimline (SL) Needle ™ Esophageal Receives Receives Stent Esophageal for Europe CE Mark in Refractory Indication Benign for EUSfor FNA WallFlex Advancing Science Covered WallFlex Expect Preceptorship Brings Endoscopy Training PartNow the of Paris Institute for Improving OutcomesImproving through Patient Education with theWorking National Foundation toMaster Class Training France in Physicians Designing the Expect Slimline (SL) Handle 7 6 7 4 5 2 10-11 12-14

Opt-in to receive ACCESS magazine electronically and email updates on new products, Opt-in to receive ACCESS magazine electronically and email www.bostonscientfic.com/endo-access-subscribe. indications and resources. Visit

Eating After Eating Placement Esophageal Stent Case Studies Articles Inside This Issue This Inside

BOSTON SCIENTIFIC NEWS “blue sky” their idea of the perfect EUS Needle? “By engaging engaging “By Needle? EUS perfect the of idea their sky” “blue — and some were looking for a different shape or tactile feel to to feel tactile or shape adifferent for looking were some — and Designing the Expect The company had a novel idea: Instead of only engaging the the engaging only of Instead idea: anovel had company The Aspiration Needle commanded an impressive market share, and was 2

A novel physician approach yields to engagement new step forward. The Slimline has several positions that I can assume during the step forward.TheSlimlinehasseveral positionsthatIcanassumeduringthe its sharpness and sharpness through form multipleits passes. them a chance not only to suggest iterative changes, but to actually actually to but changes, iterative suggest to only not achance them In its very first year on the market, the Expect the the year market, on first very In its widely praised superior for its needle penetration and ability retain to Ergonomic Comfort Ergonomic Outcomes Clinical Early accommodate their individual techniques. That set Boston Scientific Scientific Boston set That techniques. individual their accommodate options for meeting their needs meeting for options off on a unique journey to uncover and meet their customers’ needs. customers’ their meet and uncover to journey aunique on off of research and development at Boston Scientific. Boston at development and research of course of a fine needle aspiration that will reduce fatigue and probably yield course ofafineneedleaspirationthat willreducefatigueandprobablyyield cases whereIwasprettysureitgoingtobeverydifficultgetadiagnosis, define their ideal EUS device,” explained Kurt Geitz, vice president president vice Geitz, Kurt explained device,” EUS their ideal define to allow and them opinions of avariety didn’t, get to hoped we and physicians who devices our use regularly who didn’t, physicians But word came back from the marketing and field sales groups that that groups sales field and marketing the from back came word But company’s satisfied customers, what if they also reached out to to out reached also they if what customers, satisfied company’s we actuallygotadiagnosis. where youwanttogo.Andinsmalllesions,wefoundtheearlyexperience, physicians who liked the original Expect needle, physicians who who physicians needle, Expect original liked the who physicians physicians who preferred the competition? And what if they gave gave they if what And competition? the preferred who physicians not all customers had the same ergonomic and actuation preferences preferences actuation and ergonomic same the had customers all not better samples.This isprobablythemostcomfortableneedle I’veused.

Ergonomics have been sort of a lost art in endoscopy and this needle is a Ergonomicshavebeensortofalostart inendoscopyandthisneedleisa Withthisnewneedle,becauseit’s sosharp,youimmediatelygoexactly access and didn’tlike aboutthe current handle. Latin America to betterunderstand whatthey liked than 50physicians from the U.S.,Europe, Japanand Working withmarketing and sales, we engaged more

What doctors are saying about the Expect about the doctors are saying What ™ Slimline (SL)Handle

— — — David Robbins,M.D. Anand Sahai,M.D. R&D Technical Team Lead Technical R&D Brandon Alexopolous ™ Endoscopic Ultrasound

“Working with marketing and sales, we engaged more than 50 50 than more engaged we sales, and marketing with “Working “In the lab, we spent a lot of time trying to quantify things like things quantify to trying time of alot spent lab, we the “In

and gives you a clue as to what that lesion could possibly be. The ability of the and givesyouaclueastowhatthatlesioncouldpossiblybe.Theabilityofthe The team promised to meet with these physicians consistently consistently physicians these with meet to promised team The Slimline Needle to give us that nice one-to-one motion and to allow that Slimline Needletogiveusthatniceone-to-one motionandtoallowthat Enhanced Tissue Feedback and Tactile Feel Tactile and Feedback Tissue Enhanced feel inthehandlewasagreatimprovement intheproduct. what’s happeningatthetip.Ittranslatesintoreallyamazingprecision. Alexopolous says. “We worked with physicians in our R&D facility, facility, R&D in our physicians with worked “We says. Alexopolous A FRESH APPROACH TO PHYSICIAN ENGAGEMENT PHYSICIAN TO APPROACH A FRESH in their hospitals, at conferences such as DDW and UEG, and at at and UEG, and DDW as such conferences at hospitals, in their understand what they liked and didn’t like about the current handle,” current didn’t liked the and like they about what understand Expect Slimline Handle design project. design Handle Slimline Expect the on lead team technical R&D Alexopolous, Brandon explains over a short period of time. “We held regular interviews and and interviews regular held “We time. of period ashort over Dr. David Robbins, associate chief of endoscopy, Lenox Hill Hospital, Lenox endoscopy, of chief associate Dr. Robbins, David developed multiple rounds of prototypes based on their feedback, feedback, their on based prototypes of rounds multiple developed live courses held around the world.” the around held courses live Boston Scientific reached out to a wide range of thought-leading thought-leading of range wide to a out reached Scientific Boston which they then used in animal labs to simulate real life experience,” experience,” life real simulate to in animal labs used then they which really well-designed analysis, not a one-size-fits-all proposition.” one-size-fits-all a not analysis, well-designed really a was “It says. he ergonomics,” and compliance tissue resistance, process. the of integrity the with impressed particularly being recalls physicians from the U.S., Europe, Japan and Latin America to better to better America and Latin Japan U.S., Europe, the from physicians critics. toughest its to fans needle’s the biggest from physicians, Tactile feelallowsyouto feelthehardnessoforsoftnessalesion, There’s anintimateconnectionbetweenwhatyoufeelinthehandleand

™ Slimline Needle Slimline — Adam Goodman,M.D. — Anand Sahai,M.D.

BOSTON SCIENTIFIC NEWS 3

access

Anand Sahai, M.D. David Robbins, M.D. — —

Because the needle is so sharp, you immediately go exactly where you There’s very little bend in the needle, even after multiple passes. Its ability very little bend in the needle, even after multiple There’s Dr. AnnDr. Chen, director of endoscopic ultrasound at Stanford University School of Medicine bottom depending on your preference. The groove the in can middle needle to and fro within the tissue with up-and-down simple motion new design features also lower profilelocking knobs. physicians’ hands, speak it will for itself.” Physicians praisedalso Needle the for enhancing Slimline tissue Physicians reported that the new handle design exceeded their want to go, and it maintains that sharpness. It works just as well the first time Physicians predict great success Needle. for the put “You Slimline well asto well accommodate different hand sizes and techniques. The where theirfingers can rest, increaseto comfort and control as to get into difficult-to-access parts of the pancreas where there’s a lot of torque to get into difficult-to-access parts of the pancreas where there’s feedback. can “I get a sense of whether or a lesion semi-soft solid is of the thumb. Lastly, the mechanism gliding has been improved expectations. “The improvement the in landing zone significant,” is or even Robbins. cystic “That’s said Dr. sampling,” as I’m an element also servealso as a resistance point, which allows you to easily move the significantly a smootherallow to movement of the needle during biopsy.” said Dr. Chen. can “You said Dr. place your thumb either on the top or the on the scope and stay true to its initial form will ultimately benefit our patients. that unique to is this needle.” the device your in hand and it just from quality, feels like beginning not an Sahai. expert “I’m said Dr. to end,” marketing in but I think that given the quality of the device, if you can just get it into as the last time. Maintaining Sharpness and Shape

Ann Chen, M.D.

— Raman Muthusamy, M.D. Raman Muthusamy,

— Dr. Ann Chen Director of Endoscopic Ultrasound Stanford University School of Medicine — gives physicians two ergonomically defined areas ™ They brought all of my thoughts back to the drawing drawing the to back thoughts my all of brought They design, with the innovative very were and board every step of the way. way. the step of every

I was really struck by how easy the to-and-fro motion of the needle was During EUS FNA, it’s very important to be able to move the needle to and fro very important During EUS FNA, it’s

back and forth very quickly with just my thumb and my index finger, without a lot back and forth very quickly with just my thumb and my index finger, board and were very innovative with the design, every step of the way.” medicine Division, GI Centre and chief, Hospitalier de l’Université de manager, Bostonmanager, Scientific. “So much GI of endoscopyis about how a produced amazing Sahai, Anand professorresults,” said Dr. V. of process, a final designincorporating these features was available to PHYSICIAN INPUT YIELDS MEANINGFUL RESULTS can feel they have a passion for what they’re doing and, the in end, it ways,” sheways,” says. “They brought of my thoughts all back to the drawing Feedback was consistent from region to region: Physicians wanted University School of Medicine, wasimpressed. similarly “My low-friction mechanism gliding for a smoother actuation motion. The device feels hands. the in wanted physician’s We Handle the Slimline Montréal (CHUM).Montréal Expect Needle could be an option for them when performing EUS FNA.” experience working with Boston Scientific was unexpectedin many Dr. Ann Chen,Dr. director of endoscopic ultrasound at Stanford Smooth Gliding Mechanism in a variety of positions, short or long, and across all different needle gauge gliding mechanism has to be almost frictionless. I can move the needle device very quickly within the target lesion to increase the areas being sampled so the a handle that was easy to with grip, resistance minimal during FNA. of resistance. This will aid in FNA tremendously. Control ZONE to accommodate these ergonomic andtactile feel preferences so the them less in than a year. sizes, between 19, 22 and 25. That’s a real step forward. sizes, between 19, 22 and 25. That’s

­ The Handle features new Slimline handle a smaller profile and a Thanks to the accelerated customer engagement and development “The team from Boston Scientific really took theYou listen.time to “Physician preference matters,” said Bryan Bannon, senior product BOSTON SCIENTIFIC NEWS

A Guide for Patients Living with a

Biliary Metal Stent 4 indicated as MR Conditional according to ASTM F2503 and patients with Resolution Clip Devices can be be can Clip Devices Resolution with patients and F2503 ASTM to according Conditional MR as indicated

scanned following the guidelines listed on the card such as Static Magnetic Field Tesla and Spatial Gradient Tesla Field Gradient Spatial Magnetic and Static as such card the on guidelines listed the following scanned after receiving clip(s). The card is intended to identify the anatomical location and placement date of aclip of or date placement and location anatomical the identify to is intended card The clip(s). receiving after to helpto as patients well educate as caregivers. Improving Outcomes through Field parameters. A copy of the card should be used in patient records as well as given to the patient as a a as patient the to well as given as records in patient used be should card the of Acopy parameters. Field clips for the patient, physicians and MR technicians. The card acknowledges that the Resolution Clip Device is Clip Device Resolution the that acknowledges card The technicians. MR and physicians patient, the clips for personal pocket card for medical reference. medical for card pocket personal looking for information, Scientific Boston developedthree guidespatients for a living with tricks for living with an esophageal stent (i.e., pills, maintaining weight, ways to avoid/reduce avoid/reduce to pills, ways swallowing (i.e., weight, maintaining stent esophageal an with living for tricks For patients undergoing patients For endoscopic many questions placement, stent are there often about acid reflux, etc.) and contact information for additional third-party resources. third-party additional for information contact and etc.) acid reflux, post-procedure care. As a way to help to away post-procedure care. As physicians growing the to respond inquiries patients from University of Virginia, Boston Scientific developed a guide to provide information about diet and nutrition as as nutrition and diet about information provide to guide a developed Scientific Boston Virginia, of University well as recommendations on caring for an esophageal stent. The guide provides meal suggestions, tips and and tips suggestions, meal guide provides The stent. esophageal an for caring on well recommendations as gastrointestinal guides The stent. will provide physicians additional with which with resources Patient Education Patient ▲ ▲

access Placement Stent Esophageal After Eating The The

EndoVive™ An Introduction to Tube Feeding with the EndoVive Button Device Resolution

A Guide for Patients Living with an Enteral Stent ™

Patient care guides are available for patients living with a Boston Scientific tube feeding device. device. feeding tube Scientific aBoston with living patients available for are guides care Patient Clip Device MR Conditional Patient Card Clip Patient Conditional Device MR

Boston Scientific, (DFU Template 5.5in x 8.5in), DFU, Button Patient Care Guide, EN, 90721848-01A

Copies are available for health care providers from their Boston Scientific representative. representative. Scientific Boston their from providers care health for available are Copies ▲ as a general guideline for patients to help them with care and use of their device. These guides provide provide guides These device. their of use and care with help them to guideline patients for ageneral as ▲ information on the basics of tube feeding as well as the necessary steps required to ensure their stoma stoma their ensure to required steps necessary well as the as feeding tube of basics the on information site is clean and properly cared for. In addition, the guide provides problem solving tips as well as as tips solving problem guide provides for. the addition, In cared properly and is clean site Stent guides are also available at www.bostonscientific.com/endoscopy-resources. guides are alsoStent available at www.bostonscientific.com/endoscopy-resources.

suggestions for general patient care such as managing common oral and conditions. stomach and oral common managing as such care patient general for suggestions

An Introduction to Tube to EndoVive Introduction with Feeding An An Introduction to Tube Feeding with the EndoVive Button Gastrostomy Device Gastrostomy Button EndoVive the Tube to with Feeding Introduction An

– These guides are designed to help patients understand what a metal stent stent ametal what understand help patients to designed are guides – These ▲ is, and provide information about a stent placement procedure as well as as procedure placement astent about information is, provide and ▲ questions to ask their physicians. Both the enteral and biliary stent guides guides stent biliary and enteral the Both physicians. their ask to questions include a plastic identification card that can be customized by the physician physician the by customized be can that card identification aplastic include

and staff, and is sized to fit in a wallet. The patient identification card card identification patient The wallet. in a fit to is sized and staff, and includes information about magnetic-resonance compatibility for future future for compatibility magnetic-resonance about information includes

A Guide for Patients Living with an Enteral Stent Stent Enteral an with Living Patients for A Guide medical treatment. A Guide for Patients Living with a Biliary Metal Stent Metal aBiliary with Living Patients for A Guide – Working in conjunction with a nutritionist from the the from anutritionist with in conjunction – Working is for patients to take home with them them with home take to patients is for ™ Gastrostomy Tube Gastrostomy and

and and

Static magnetic field of 1.5 and 3 Tesla with: Tesla 3 and 1.5 of field magnetic Static Mode for a maximum scan time of 15 minutes of continuous scanning at 1.5T and at 3T. at and 1.5T at scanning continuous of minutes 15 of time scan maximum a for Mode

Static Magnetic Field Magnetic Static Maximum whole body averaged specific absorption rate (SAR) of 2 W/kg in Normal Operating Operating Normal in W/kg 2 of (SAR) rate absorption specific averaged body whole Maximum

Spatial gradient field of 2500 Gauss/cm (value extrapolated) and less and extrapolated) (value Gauss/cm 2500 of field gradient Spatial

ASTM F2503. A patient with this clip(s) can be safely scanned under the following conditions: following the under scanned safely be can clip(s) this with patient A F2503. ASTM

Non-clinical testing has demonstrated the Resolution the demonstrated has testing Non-clinical

Magnetic Resonance (MR) Information (MR) Resonance Magnetic Esophageal Stent Placement Stent Esophageal

After Eating Anatomical Location: Anatomical

Date Placed: Date Resolution

® Clip Device Clip

serve serve

®

to according Conditional MR is Clip

per ASTM F2503 ASTM per

MR Conditional Conditional MR

BOSTON SCIENTIFIC NEWS 5

access

and

. help patientshelp understand complex medical terminology, patients a practice in setting to explain help resource forhealth care professionals working with clinical implications.clinical With easy web access, the website’s co-hosted on www.pancreasfoundation.org www.animatedpancreaspatient.com Boston Scientificis funding the project through an learning programs could serve as an educational disease states, diagnostic testing, procedures and unrestricted education grant. The information be will the procedures, and the benefits diagnosticof and therapeutic pancreatic endoscopy, EUS FNA and ERCP. indications for the procedures, risks associated with Animations web tool help patients learn about pancreatic diseases.

. Dave Pierce Dave Scientific Boston President, — to develop an interactive

Education is critical to helping patients manage the challenges pancreatic of disease and making informed medical decisions about their care

between patients and their physicians. medical decisions about their said Dave care,” Pierce, president of Boston Scientific Endoscopy. are“We proud pancreatic disease states and procedures. The new program modules be part will of the foundation’s current Pancreas Foundation challenges of pancreatic disease and making informed Boston Scientific is working with the National website that works to provide easy-to-understand Using a mix of animations, physician testimonials as well learning program for those seeking information on EUS FNA and ERCP – two procedures that are playing as downloadable information, the learning program will animportant role helping diagnose in pancreatic disease.” to be leaders helpingcreate in sections dedicated to information for patients, and to enhance communication to Provide Global Online Resources for Patients Resources Online to Physicians Provide and Global

National Pancreas Foundation Foundation Pancreas National Working with the “Education critical is to helping patients manage the

BOSTON SCIENTIFIC NEWS The active participation of the trainee is a key element element is akey trainee the of participation active The The expert starting the procedure is responsible for for is responsible procedure the starting expert The 6 Physicians in France Training to Class Master Brings Preceptorship a welcome for attendees and and attendees for awelcome includes day first The In order to meet the ever-increasing need for specialized endoscopy training, St. Joseph Joseph St. training, endoscopy specialized for need ever-increasing the meet to order In endoscopic ultrasound (EUS). Developed by Dr. Christian Boustière, the two-day training is is training two-day the Boustière, Dr. by Christian Developed (EUS). ultrasound endoscopic Hospital in Marseille, France, implemented a preceptorship program to expand physicians’ physicians’ expand to program apreceptorship implemented France, Marseille, in Hospital is devoted for presentations, including videos to provide provide to videos including presentations, for is devoted indications and the types of devices to be used. Time Time used. be to devices of types the and indications designed for physicians who are skilled endoscopists yet have limited experience in in experience limited have yet endoscopists skilled are who physicians for designed and (ERCP) cholangiopancreatography retrograde endoscopic of areas the in skills thoroughly reviewed, including pathologies, procedure procedure pathologies, including reviewed, thoroughly the case, and ensures the technique is performed is performed technique the ensures and case, the schedule of cases for the next day and the pre-selected pre-selected the and day next the for cases of schedule the with concludes day The specialty. medical subject pancreatico-biliary endoscopy. endoscopy. pancreatico-biliary an update on technical innovations, guidelines or recent recent guidelines or innovations, technical on update an a review of patient cases to be treated. Each case is case Each treated. be to cases patient of a review adequately as discussed during the case presentation. under general anesthesia and intubation for ERCP. for intubation and anesthesia general under one of the trainees will perform all or part of the the of all part or will perform trainees the of one for ERCP and one for EUS. All procedures are performed performed are procedures All EUS. for one and ERCP for Depending on the level of difficulty of the procedure, procedure, the of difficulty of level the on Depending devices. The second day is fully dedicated to conducting conducting to dedicated is fully day second The devices. WORKING ALONGSIDE EXPERTS ALONGSIDE WORKING can regain control at any time if deemed necessary. necessary. deemed if time any at control regain can procedures scheduled in two endoscopic rooms, one one rooms, endoscopic in two scheduled procedures procedure under direct supervision of the expert who who expert the of supervision direct under procedure publications around major congresses related to the the to related congresses major around publications access

The sessions at St. Joseph Hospital are are Hospital Joseph St. at sessions The St. Josephs where there is a high volume of endoscopic endoscopic of is ahigh volume there where Josephs St. in everyday practice. practice. in everyday technical issues encountered often and diagnostic the about learn to well learning as as exchange theoretical techniques their improve time same the at and levels, competency their test to variety of cases allows trainees trainees allows cases of variety additional master classes in ERCP and pancreatico- and in ERCP classes master additional experts. Trainees benefit from the the from Trainees benefit experts. of this training. It allows for trainees trainees for allows It training. this of ongoing education and training at select medical medical select at training and education ongoing from physicians’ experiences. The The experiences. physicians’ from facilities. Training of this sort is possible in hospitals like like hospitals in possible is sort this Training of facilities. expertise is readily available. Having received positive positive received available. Having is readily expertise feedback from participants, the hospital plans to pursue pursue to plans hospital the participants, from feedback with step-by-step guidance from the the from guidance step-by-step with program that is designed to support support to is designed that program preceptorship Scientific’s Boston of part procedures, the facility is well equipped and physician physician and is well equipped facility the procedures, biliary EUS training with two additional sessions in 2014. in 2014. sessions additional two with training EUS biliary

this practice, this furthering to critical is class master this as such education continual for opportunities endoscopy. Creating training in gastrointestinal environment of academic the far by exceeds which training and learning rigorous requires endoscopy in biliary and pancreatic precisely, more and, endoscopy Training in therapeutic — Dr. Boustière Boustière — Dr.

BOSTON SCIENTIFIC NEWS 7

access

Peter D. Siersema, M.D., Ph.D. Professor of Gastroenterology of Professor

Direct Visualization

™ . partially covered WallFlex Esophageal Previously, the fully covered and for the palliative treatment of malignant esophageal strictures. strictures. esophageal received CE Mark and FDA clearance biological and non-biological models to recreate and hands-on and didactic medical training endoscopy. in multiple languages via the onsite simultaneous continuum of endoscopists and pulmonologists across courses from basic to advanced levels a range in of catheterization fully lab equipped with fluoroscopy capabilities. In addition, training can be conducted in Boston Scientific offers a broad curriculum of training Europe,” said Paraic Curtis, vice president of Endoscopy Scientific. Boston Europe, ESD, cholangioscopyESD, and bronchial thermoplasty. essential to maintaining good practice clinical and endoscopy training at the Institute for Advancing education. Physicians have access to a complete ultrasound processors, a SpyGlass It contains two endoscopic towers, two endoscopic specialtiesand EUS, techniques EMR/ including ERCP, simulate adapted clinical conditions for training and improving the quality of patient care. hope We that the translation facilities. Science become will an integral part of the training System, range a full of endoscopes, and numerous The Institute fully is equipped to support integrated “Hands-on training and peer-to-peer education are

Esophageal Stent Esophageal CE Europe Mark Receives in ™ Paraic CurtisParaic Vice President of Endoscopy Endoscopy of President Vice Scientific Boston Europe, The WallFlex Esophageal Fully Covered Stent is not approved in the U.S. for the treatment of benign esophageal strictures. — Note: WallFlex

The advantage of the WallFlex Esophageal Fully Covered Stent is its ease-of-use and now removability, removability, now and ease-of-use is its Stent Fully Covered Esophageal WallFlex the of advantage The benign strictures with refractory patients treat to me which allows

The development of endoscopy training at the Institute for Advancing Science demonstrates Boston Scientific’s continued commitment to providingindustry-leading trainingand education in partnership with physicians and societies to further the practice of endoscopy. Endoscopy professional education and training patients with refractory benign strictures,” said Peter Siersema, D. Utrecht, The Netherlands. benign esophageal strictures. The fully covered stent treatment metal a new strictures. provides The option esophageal fully benign M.D., PH.D.,M.D., professor of gastroenterology, head, Department of facilities designed to meet the educational needs of endoscopists, endosonographers and pulmonologists. endoscopists, endosonographers pulmonologists. and are now part of the multi-disciplinary programs available at the Boston Scientific Institute for Advancing Science Gastroenterology and Hepatology at University Medical Center in in Paris,in France. The Institute offers world-class training its ease-of-use and now removability, which allows me to treat for patients with malignant and benign refractory benign and strictures. esophageal patients withfor malignant

Advancing Science Endoscopy Training PartNow of Institute the Paris for The WallFlex Esophageal Fully Covered Stent received CE Mark approval in Europe for the treatment for Europe Covered refractory in of Stent received CE Mark approval Fully Esophageal The WallFlex “The advantage of the Esophageal WallFlex Fully Covered Stent is

AN INTERVIEW WITH Maria Stewart, director of Health Economics & Reimbursement, Boston Scientific, on changes impacting the U.S. health care industry.



What do you see as the most pressing issue facing How is the Boston Scientific Endoscopy Health

Q hospitals and physicians today? Q Economics & Reimbursement team supporting Hospitals are being asked to improve quality of care and outcomes while its health care partners in this changing environment? demand is increasing and funding/payment is constrained. For example, Boston Scientific Endoscopy’s Health Economics & Reimbursement team health care reform is on the top of everyone’s mind. Hospitals are working is actively leading efforts to advocate for appropriate coverage and to comply with all of the mandatory requirements associated with the payment for GI and pulmonary endoscopy procedures, which we believe value-based purchasing, hospital readmission reduction and hospital- is critical if patients are to have access to all relevant treatment options. acquired conditions programs. Hospitals must provide data on each of the In addition, through discussions with hospital administrators, we have specified parameters in order to receive their full payment update. In this BOSTON SCIENTIFIC NEWS BOSTON learned that education for hospital staff on the changes associated with environment, it will be critical for hospitals to increase efficiency while health care reform is needed. To support the education of our healthcare improving quality of care and patient satisfaction. partners, the Boston Scientific Health Economics & Reimbursement Endoscopy team annually sponsors a complimentary reimbursement Can you tell us about the impending Q webinar during which an expert in the field reviews the impact of health ICD-9 to ICD-10 coding transition? reform and upcoming changes in coding and payment. This webinar In the United States, hospitals are preparing for the implementation receives positive reviews and draws approximately 300 attendees each of the International Classification of Disease (ICD-10) coding system. The year. In addition, the team provides onsite education for hospitals, current ICD-9 code set used to report medical diagnoses and inpatient ambulatory surgery centers and physicians on these important topics. procedures is expected to be replaced by ICD-10 in October 2014. This will be a major change for hospitals. They will be going from using a system With respect to the transition to ICD-10, Boston Scientific has worked with approximately 13,000 diagnoses codes to a system with 68,000 with coding experts to develop an ICD-10 educational webinar and coding diagnosis codes and from approximately 3,000 inpatient procedure codes cross-reference tools. These tools will be available on the Boston to 87,000. To help ensure accurate coding, payment and claims processing, Scientific website, and will be an additional resource to our health care hospitals will need to train staff and coordinate a transition plan with partners as they transition from the ICD-9-CM to ICD-10 coding system. the support of the coding, clinical, IT and finance departments. Physicians How can a customer reach out to request and their staff members will also need to familiarize themselves with Q new ICD-10 diagnosis coding. If the transition to ICD-10 is not properly reimbursement information or education? implemented, they could have denied claims, delays in processing and To request information on reimbursement, U.S. customers may contact the payments, etc. Endoscopy Reimbursement Helpdesk at 1-800-876-9960 ext. 54145 or via email at: [email protected]. Update on Endoscopy Gurukul

Since its inception in 2011, the Boston Scientific School of Endoscopy in India, known as Endoscopy Gurukul, has quickly gained momentum and established itself as a center of expertise for gastrointestinal (GI) education and training. More than 800 medical professionals have registered with Endoscopy Gurukul to take advantage of its many learning opportunities. The school offers a variety of ways to learn, including hands on, procedural video libraries at conferences, paramedical staff training for skill enhancement, patient education and more.

Left to right: Dr. T.S. Chandrasekar, MedIndia Hospitals “Endoscopy Gurukul is an innovative initiative from Boston Scientific that has (Chennai) moderates a discussion on ERCP with completely changed the landscape of training endoscopists in India.” Dr. Randhir Sud, Medanta Institute of Digestive & Hepatobiliary Sciences (Gurgaon); Dr. D. Nageshwar – Dr. D. Nageshwar Reddy, chief of gastroenterology and therapeutic Reddy; and Dr. Amit Maydeo at the Mumbai Live endoscopy at the Asian Institute of Gastroenterology, Hyderabad, India. Endoscopy 2013 conference.

“The Endoscopy Gurukul is a highly positive step taken by Boston Scientific to enhance endoscopic education in our country.” – Dr. Amit Maydeo, chairman, Baldota Institute of Digestive Sciences, Look for Endoscopy Gurukul Global Hospitals, Mumbai, Maharashtra learning opportunities at conferences throughout India in 2014.

8 access BOSTON SCIENTIFIC NEWS 9

access

This 1.28 megawatt solar energy system will generate an average of 1,685,000 kilowatt hours a year, approximately 25% of the facility’s energy needs, or enough power to serve 145 average-sized American homes a year. This facility, located in Quincy, Massachusetts, is home international Boston Scientific’s to distribution center, which distributes more than 15.8 million medical device units per year to 50 all U.S. states 46 countries. and

RX Delivery System by Reduced – ™ – Certified – – Plastic packaging was percent made 13 into the Boston Scientific is working to leverage leverage the to is working Boston Scientific As Practice of members Greenhealth, – New packaging made is of fully recyclable REC-2-0 – megawatt A 1.28 solar energy 4 Biopsy Forceps Biopsy 4 ™ Biliary Stent with NaviFlex ™ ENERGY AND SUSTAINABILITY PRODUCT PACKAGING

Dilation Balloon Dilation ™ distribution center in Quincy, Massachusetts distribution center 83 fewer trucks moving product from New to the York Boston Scientific 1,653 fewer pallets per year moving from Costa Rica to the Massachusetts A reduction overall in packaging materials by 42,452 pounds per year   • • • Boston Scientific has been certified to the FTSE4Good Corporate Social Responsibility index since 2004. An investment index managed by the London Stock Exchange, it measures the performance of companies that meet globally recognized standards of corporate responsibility. high-density polyethylene. kilowatt hours approximately a year, 25 percent procedure room. In addition, these packaging changes are expected to result in: construction of new and modification buildings of centers worldwide. less shelf space (between 24-36% less) – helping decrease the task of restocking existing facilities – seven facilities LEED certified. of the energy needs for Boston Scientific’s and improve efficiencies when moving product from the stock room to the at all 14 major manufacturing 14 at all and distribution system will generate averagesystem an of 1,685,000 will smaller; a box of 5 was made by smaller 35 percent. The new packaging requires the previous package. international distribution center in Quincy, Mass. 28 percent. The new fully recyclable packaging uses 23 percent less material than Advanix Incorporating LEED standards Achieving ISO14001 certification CRE Leveraging solar Radial Jaw and ongoing initiatives: ongoing and practices for health care organizations as a way to of meet the as needs carepractices organizations health for information, education and tools available on the best environmental the on best environmental available tools and education information, accomplishments Boston of some are its Here Scientific’s customers. Boston Scientific Green Initiatives – Initiatives Green Scientific Boston

�  �  �  �  �  �  Making a Difference Making

Colorectal cancer affects an estimated 1 in 20 Americans. WHAT’S YOUR LEVEL OF RISK?

Take the Colorectal Cancer Risk Assessment Quiz to find out.

for The Lustgarten

that being is used to fund

Colon Cancer Risk Assessment

$35,000 $20,000

www.lustgarten.org www.coloncancerpreventionproject.org www.ccalliance.org The Lustgarten Foundation: The Colon Cancer Prevention Project: The Colon Cancer Alliance: by increasing awareness, sponsoring and more than pledge program. Prevention Project’s Boston Scientific’s Close the Gap is colorectal and pancreatic cancer awareness raised cancers through a variety of awareness- cancer Screening Assistance Program and Foundation’s pancreatic cancer research developing educational programs, and and programs, educational developing generating and fund raising activities. The team from gastrointestinal and pulmonary diseases eliminate treatment disparities in high-risk, underserved patient populations suffering suffering populations underserved patient activities, please visit our partners’ websites: an ongoing program focused on initiatives to awareness for colorectal and pancreatic Colon Cancer sponsor of the the Colon Cancer new colorectal Alliance’s in 2013, the 2013, in team has worked to raise improving access to care. Since its inception initiatives. Close the Gap the also is primary Patient Education and �  �  �  Access Care to To learn moreTo about how to get involved with Works to Improve to Improve Works Initiative Close the Gap Initiative GASTROENTEROLOGY 10 Fine-Needle Aspiration Endoscopic Ultrasound A ChallengingCaseof conducted EUS tutorials for more than than more for tutorials EUS conducted the in centers EUS busiest the of one Hospital, University of Montréal is is Montréal of University Hospital, 2,800 cases per year and 12-14 cases 12-14 and cases year per cases 2,800 world, conducting approximately approximately world, conducting based been has practice Dr. Sahai’s solely on EUS since 1996. The Center Center The 1996. since EUS on solely per day. Since 2000, Dr. Sahai has has Dr. Sahai 2000, day. Since per 500 physician attendees. attendees. physician 500 access

1 To visualize and biopsy hilar lesions, the echoendoscope must often be placed in a long scope scope in along placed be often must echoendoscope To hilar the lesions, biopsy and visualize The echoendoscope was then re-advanced into the bulb and the lesion was relocated. relocated. was lesion the bulb and the into re-advanced then was echoendoscope The As is often the case, the first pass was positive for adenocarcinoma and there were no were there and adenocarcinoma for positive was pass first the case, the is often As lesion aproximal to due jaundice obstructive with presented female A 72-year-old fine needle aspiration (FNA), if possible, since the patient was not a surgical candidate. surgical a not was patient the since possible, if (FNA), aspiration needle fine its sharpness made penetration of the duodenal wall exceptionally easy. The Expect Slimline Expect The easy. wall exceptionally duodenal the of penetration made sharpness its then inserted into the operating channel and locked in place in place locked and channel operating the into inserted then to the duct. the to the scope, the endosonographer may be in an uncomfortable posture, and the needle may be be may needle the and posture, in uncomfortable an be may endosonographer the scope, the suspicious for cholangiocarcinoma upon magnetic resonance cholangiopancreatography. An An cholangiopancreatography. resonance magnetic upon cholangiocarcinoma for suspicious In this case, the Expect the case, this In always inserting the needle into the scope when the scope is straight; this makes insertion insertion makes this is straight; scope the when scope the into needle the inserting always OUTCOME ANDCONCLUSION extremely well. After identifying the lesion and site to biopsy biopsy to site and lesion the identifying well. After extremely endoscopic ultrasound (EUS) was requested to clarify the nature of the lesion and to perform perform to and lesion the of nature the clarify to requested was (EUS) ultrasound endoscopic easier and avoids trauma to the operating channel.) channel.) operating the to trauma avoids and easier exited easily from the operating channel channel operating the from easily exited needle the required, torque counter-clockwise extreme and position scope long the Despite FNA Needle also provides a very precise tactile response. As a result, we were able to to able were we aresult, As response. tactile precise avery also provides Needle FNA was also required. was withdrawn into the stomach in a more straight position. The 25g Expect SL Needle was was Needle SL Expect 25g The position. straight in amore stomach the into withdrawn was complications. position in the duodenal bulb with significant counter-clockwise torque. In this position, it position, this In torque. counter-clockwise significant bulb with duodenal in the position precisely target the small, intra-ductal stricture while avoiding vascular structures posterior posterior structures vascular avoiding while stricture small, intra-ductal the target precisely success in cases of EUS-FNA of small lesions with difficult scope position. scope difficult with lesions small of EUS-FNA of cases in success ensure help can needle Expect-SL the of feel tactile exceptional and sharpness hard to move. In this case, the lesion was particularly small. Therefore, very precise targeting targeting precise very small. Therefore, particularly was lesion the case, this In move. to hard may be very difficult to perform EUS-FNA because the needle may be difficult to insert into into toinsert be difficult may needle the because EUS-FNA perform to difficult very be may PROCEDURE ANDTECHNIQUE PATIENT HISTORY This challenging case highlights how the ease of actuation, visibility, visibility, actuation, of ease the how highlights case challenging This ™ Slimline (SL) Endoscopic Ultrasound Aspiration Needle performed performed Needle Aspiration Ultrasound Endoscopic Slimline (SL) 2 (Figures 3 and 4) 3and (Figures l’Université deMontréal,CANADA Chief, GIDivision,CentreHospitalierde Professor ofMedicine ANAND V. SAHAI,M.D.,MSC(EPID),FRCPC CASE PRESENTEDBY: . The needle was easily visible, and visible, easily and was needle . The 3 (Figure 1) (Figure (Figure 2) (Figure , the echoendoscope echoendoscope , the . (We recommend recommend . (We 4 GASTROENTEROLOGY 11 4

access

3 CASE PRESENTED BY: BY: CASE PRESENTED M.D. APARICIO, JOSÉ RAMÓN Endoscopy Unit Universitario de Alicante Hospital General Alicante, SPAIN SL Needle a very useful tool to puncture ™ The 25 gauge Expect SL Needle is especially useful 2 for puncturing small lesions and transduodenal use. and The puncturingfor lesions small make the Expect biliary tract are rare and usually not taken intoaccount the in hyperplasia papillary changes. No atypia, mitosis or malignancy cytology obtained by ERCP rarely is diagnostic because the tumor chromatic oval eccentric nuclei. The nuclei. eccentric biliary epitheliumoval shows reactivechromatic cases reported literature in and this being the first case of cytologic differential diagnosis of patients with obstructive jaundice. Brush location at the level of the biliary tract rare, is with only a few dozen inaccessible lesions in which the scope is in a forced position. diagnosis by EUS FNA. granular cytoplasmic positivity protein. for S-100 The cytologic originatesfrom the thicknesswall of the common duct bile and not in of 34 years, and more often females of African heritage. SUMMARY AND DISCUSSION SUMMARY evidenced by histological and immunohistochemical test results.Its excellent ultrasound visualization and low deformability ultrasound low and visualization excellent skin and subcutaneous tissue. It originates Schwann in as cells signs were observed and an immunohistochemical studyshowed the performance high of FNA the in context of biliary strictures make thebiliary epithelium. Most patients are young, with an average age it an ideal and safe method to evaluate patients with obstructive tumor that frequently is located the in skeletal muscle of thetongue, jaundice. findings were consistent with the existence of a granular-cell tumor. A granular-cell tumor, orA granular-cell Abrikssoff’s tumor, a benign is mesenchymal tumor, The ability of EUS FNA to properly evaluate the biliary system and The preoperative diagnosis difficult is because benign tumors of the

­

1b . . The distal area of the duct bile was Endoscopy 2013; 45:883-9. Am J Gastroenterol 2004; 99:45-51. El Chafic AH et al. Impact of preoperative endoscopic ultrasound-guided fine needle aspiration on postoperative recurrence and survival in cholangiocarcinoma patients. Fritscher-Ravens A et al. EUS-guided fine-needle aspiration of suspected hilar cholangiocarcinoma in potentially operable patients with negative brush cytology. Saito J et al. Granular cell tumor of the common bile duct: a Japanese case. World J Gastroenterol 2012; 18: 6324-7. References: 3)  2)  1)  showed the presence of a benign proliferative 1a . The patient was referred for an endoscopic (Figure 4) (Figures and 1a 1b) (Figures and 1a 1b) Slimline (SL) Slimline Needle (two passes), having previously ™ biliary tree PROCEDURE PATIENT HISTORY PATIENT normal. No lymphadenopathy or local hepatic lesions were observed. performed showing of dilation the intrahepatic biliary duct. There was normal. At the level of the common duct bile (CBD) a regular wasno presenceof stones thein andthe pancreas Under deep propofol sedation controlled by the endoscopist, EUS was dilation ofdilation the intrahepatic duct bile secondary to a short stenosis of lesion of mesenchymal lineage consisting of sheets and plates gallbladder with cholesterolosis without stones and a normal-sized (Figures 2 and 3) During a hospital examination, a doctor discovered conjunctival Expect of large round cells with granular eosinophilic cytoplasm and hyper and cytoplasm oflarge round with cells granular eosinophilic observed of hepatic enzymes. The abdominal ultrasound performed showed a episodesof abdominalpain duringone-year a period.In one ofthese episodes, he went to the emergency room of another hospital where ultrasound (EUS) examination. administered a prophylactic intravenous dose of ciprofloxacino 400mg. thickening of the duct bile of wall a length and was of 7mm 13mm theydetected level of bilirubin a mg/dL4 together with level high a jaundice. He underwent magnetic resonance imaging that showed EUS FNA-based Diagnosis FNA-based EUS in Tumor of a Granular-cell Duct the Bile A fine-needle aspiration (FNA) was performed a using 25 gauge The patient was referred regular to his specialistfor further study. The cytology This patient a 24-year-old is male nursing student with recurrent 7mm at7mm the common hepatic duct that was suspicious for malignancy GASTROENTEROLOGY A 78-year-old female was admitted to the emergency room with with room emergency the to admitted was female A 78-year-old 12 Klatskin Tumor Metal StentingasTreatment fora Bilateral BiliarySelf-expanding the second Dreamwire Guidewire into the left duct required use of of use required duct left the into Guidewire Dreamwire second the for drainage nasobiliary by followed duct, hepatic right the into showed a mass lesion at the confluence of the right and left hepatic hepatic left and right the of confluence the at lesion amass showed an Autotome underwent a percutaneous transhepatic endoscopic endoscopic cholangiography transhepatic apercutaneous underwent of a TJF-180 scope into the right duct, while successful placement of of placement successful while duct, right the aTJF-180 into of scope obstruction of the other stent was revealed as well as signs of well of signs as as revealed was stent other the of obstruction complete and stent one of ERCP, obstruction the During apartial days. Laboratory data showed a total bilirubin of 12.9 mg/dl, and and bilirubin 12.9 of mg/dl, atotal showed data Laboratory days. conjugated bilirubin 6.3 mg/dl. A CT scan and ultrasonography ultrasonography and scan ACT mg/dl. bilirubin 6.3 conjugated ten about for urine dark and fever, itch jaundice, skin of complaints cholangitis. The plastic stents were removed. ADreamwire removed. were stents plastic The cholangitis. capabilities of the Autotome Sphincterotome, we were able to to able were we Sphincterotome, Autotome the of capabilities cannulation technique technique cannulation rendezvous the using (ERCP) cholangiopancreatography retrograde Performance Guidewire 0.035 Performance retrograde day) 10th the (on subsequent and cholangitis, reactive PROCEDURE PATIENT HISTORY bile ducts (Bismuth-IVC). Four months prior to admission, she she admission, to prior months Four (Bismuth-IVC). bile ducts bilateral stenting with two plastic stents. stents. plastic two with stenting bilateral access ™ RX 44 Cannulating Sphincterotome. Using rotating rotating Using Sphincterotome. Cannulating 44 RX 1 (Figure 1) (Figure The safety and effectiveness of the WallFlex Biliary Stent for use in the vascular system has not been established. been not has system vascular the in use for Stent Biliary WallFlex the of effectiveness and safety The WARNING: N OTE Use of the WallFlex Biliary RX Fully Covered Stent for the treatment of benign strictures or stenoses has not been cleared for use in the United States. States. United the in use for cleared been not has stenoses or strictures benign of treatment the for Stent Covered Fully RX Biliary WallFlex the of : Use was placed via the working channel channel working the via placed " was for biliary plastic stent placement placement stent plastic biliary for 2 ™ High High 4 This case represents the possibilities of endoscopic therapy using using therapy endoscopic of possibilities the represents case This these types of devices to treat a difficult cholangiocarcinoma cholangiocarcinoma a difficult treat to devices of types these the hospital on the fourth day. fourth the on hospital the the left hepatic ducts by advancing the guidewire. Using the RX RX the Using guidewire. the advancing by ducts hepatic left the We then performed a subsequent bilateral passage of fully uncovered uncovered fully of passage bilateral asubsequent performed We then Within a short time, the patient improved and was discharged from from discharged was and improved patient the time, ashort Within found the orifice of the left hepatic duct and selectively cannulated cannulated selectively and duct hepatic left the of orifice the found ducts RX Biliary Endoprosthesis Stent System 8x100mm) into the left and and left the into 8x100mm) System Stent Endoprosthesis Biliary RX Locking Device, both guidewires were fixed in right and left hepatic hepatic left and right in fixed were guidewires both Device, Locking right biliary ducts ducts biliary right DISCUSSION metal stents (WallFlex stents metal navigate the tip of the sphincterotome in the common bile duct, bile duct, common in the sphincterotome the of tip the navigate multiple stones and sludge from the left hepatic ducts. hepatic left the from sludge and stones multiple Gentle placement of self-expanding self-expanding of placement Gentle situation. (Bismuth-IVC) POST-PROCEDURE biliary obstruction. amalignant of palliation effective in role agreat plays metal stents allows for adequate duct drainage, which which drainage, duct adequate for allows stents metal (Figure 2) (Figure 3 and the sphincterotome was separated and removed. removed. and separated was sphincterotome the and (Figures 3, 4 and 5) 4 and 3, (Figures 5 ™ Biliary RX Stent 8x100mm and WALLSTENT and 8x100mm Stent RX Biliary Moscow, Medical RehabilitationCenter N.I. Pirogov, MoscowUniversityHospital Russia StateMedicalUniversity O.A. SHCHIPKOV, E.V. GORBACHEV S.A. BUDZINSKIY, K.B.LUMMER, PROFESSOR E.D.FEDOROV, E.V. IVANOVA, CASE PRESENTEDBY: RUSSIA followed by elimination of of elimination by followed

GASTROENTEROLOGY 13

It also . 2 First, morbidity access

. In this patient with stage 3 . In addition, patients with a primary 1 CASE PRESENTED BY: BY: CASE PRESENTED M.D. EVANS, ASHLEY T. Clinic Digestive Health Boise, Idaho, USA than emergent surgery management of colonic obstruction.management of colonic placement of expandablemetal stents in the placement of a colonic stent. bowel prep and non-emergent, lowanterior resection multiple bowel movements within hours afterwards. He his family. his family. He was family. dischargedhis home on low-residue a diet. seems that colonic stent insertion followed by palliation ofpalliation advanced disease and preoperative IV rectal cancer, improved quality of life and time complete obstructive relief of his symptoms, passing weeks so that the patient could spend the holidays with with diverting was successfully performed. with family was also an important benefit of decompression. In this case, successful placement of an felt enough well that he asked for surgery to be delayed enteral stentacross malignanta colonicstricture and mortality have been shown to be substantially lower an elective basis OUTCOME / POST-PROCEDURE CONCLUSION until after Christmas so he could spend the holiday with anastomosis appear to have higher survival rates than allowed for non-emergent resection of this patient’s Colonic stents are an incredibly useful tool for both elective surgery is more effective and less costly those withemergent diverting tumor a prepped in bowel. In addition, decompression of the bowel allowedsurgery to be postponed several patients in whose colonic resection canbe performed on There are several advantages to preoperative The patient tolerated the procedure and well had Three weeks the later, patient completed cleansing a

™ . . A cannula Colonic Stent (Figure 5) ™ (Figure 2) . A fluoroscopic waist was . Using a felt-tipped the marker, (Figure 4) . With insufflation, a pinpointlumen was (Figure 3) Gastrointes Endosc 2004;60:865. Targownik LE , Spiegel BM, Sack J, et al. Colonic stent vs emergency surgery for management of acute left-sided malignant colonic obstruction: a decision analysis. Surg Gynecol Obstet 1992; 174:513. Fielding Wells LP, BW. Survival after primary and after stage resection for large bowel obstruction caused by cancer. Br J Surg 1974; 61:16. Leitman IM, Sullivan JD, Brams D, DeCosse JJ. Multivariate analysis of morbidity and mortality from the initial surgical management of obstruction carcinoma of the colon. References: bowel PROCEDURE PATIENT HISTORY PATIENT 3)  markings were used to the guide ideal placement of the proximal and distal margins of the tumor planned to relieve the obstruction. presented to the hospital with nausea, vomiting, 2)  was used to a .035 guide x 450 Hydra Jagwire was passed over the guidewire and the on-screen with plans to proceed witha low anterior resection once chemotherapy was optimized. Unfortunately, he Upon intubation of the with the sigmoidoscope, liquid stoolliquid passing from above loss, tenesmus and rectal bleeding. A CT scan and biopsy guidance, advance across the stricture to the upstream 90mm through-the-scope (TTS) WallFlex (Figure 1) obstructing rectal mass after presenting with weight oflivera lesion confirmed stage-IVdisease. He received an obstructing rectal mass was encountered at 8cm and bowel contents immediately began flowing across and distal edges of the obstructing mass. A 25mm x visible withinvisible the mass with amount a small and of air visualizedwith good placement of the stent across the abdominal pain and distension six days before Christmas. stent. The stent was easily deployed and upstream air Guidewire into the lumen, and under fluoroscopic the stricture with enteral stent placement was fluoroscopicimage was marked to delineate the proximal five months of palliative radiation and chemotherapy 1)  A 62-year-old man wasdiagnosed with a nearly A CT scan showed distal colonic obstruction. A flexible 5 4 3 2 1 Malignant Colonic Neoplasm Neoplasm Colonic Malignant Non-emergent Resection of a of a Resection Non-emergent to Surgery and Allows for and Allows to Surgery Stenting Serves as Bridge as Bridge Serves Stenting GASTROENTEROLOGY A CT scan confirmed the relapse of massive neoplastic neoplastic massive of relapse the confirmed scan A CT A self-expanding uncovered WallFlex uncovered self-expanding A 2005 in August surgery underwent female A 74-year-old 14 Without Complications Placement Long-term ColonicEndoscopicStent A ClinicalCaseofa 25mm) was used. The proper study of the stenosis stenosis the of study proper The used. was 25mm) intestinal obstruction by a new ab-extrinsic neoplastic neoplastic ab-extrinsic anew by obstruction intestinal treatment with APC APC with treatment that showed neoplastic showed that epithelial proliferation, several years years several stent incorporated in the neoplastic tissue. Another Another tissue. neoplastic in the incorporated stent stenosis of the colorectal anastomosis, as evidenced by by evidenced as anastomosis, colorectal the of stenosis for cancer ovarian by caused rectum the of stenosis Currently, the patient is undergoing chemotherapy chemotherapy is undergoing patient the Currently, Colonic Stent System (length 90mm - 25mm diameter) diameter) -25mm 90mm (length System Stent Colonic In order to treat the anastomotic stenosis, a self-expanding aself-expanding stenosis, anastomotic the treat to order In and metastases. It also showed a rectal metallic metallic arectal also showed It metastases. liver and anastomosis, approximately 10-14cm from the anal verge. anal 10-14cm the from approximately anastomosis, the confirmed Acolonoscopy scan. CT abdominal an November 2008, after chemotherapy, she developed an an developed she chemotherapy, after 2008, November endoscopic exam is scheduled for three months after the the after months three for is scheduled exam endoscopic originating from ovarian cancer cancer ovarian from originating occurred by performing a using a pediatric a pediatric using a colonoscopy performing by occurred for a left hemicolectomy caused by extrinsic neoplastic neoplastic extrinsic by caused hemicolectomy aleft for disease, due to the presence of peritoneal carcinomatosis carcinomatosis peritoneal of presence the to due disease, without clinical signs of colonic obstruction or rectal rectal or obstruction clinical colonic of signs without clinical obstruction. The stent remained patent for for patent remained stent The clinical obstruction. the of resolution acomplete to led that placed was coagulation (APC) coagulation the of treatment the for performed was colonoscopy which she had undergone surgery a few years prior. In years afew surgery undergone had she which compatible with the diagnosis of colonic localization localization colonic of diagnosis the with compatible stent inside the mucosa the on performed then were biopsies ingrowth; neoplastic stent showed colonoscopy a bleeding, rectal 2013, after June In chemotherapy. presence of a neoplastic stenosis of the colorectal colorectal the of stenosis aneoplastic of presence neoplastic tissue within the stent using argon plasma plasma argon using stent the within tissue neoplastic nasogastroscope exclusively designed for this procedure. procedure. this for designed exclusively nasogastroscope metal uncovered stent (WallFlex length 90mm, diameter diameter 90mm, length (WallFlex stent uncovered metal PROCEDURE PATIENT HISTORY bleeding, and her general condition is fair. The next is fair. next condition The general her and bleeding, access (Figure 1) (Figure (Figures 3 and 4) 3and (Figures (Figure 5) (Figure and through several cycles of of cycles several through and . (Figure 2) (Figure . . ™ Single-Use Single-Use The choice of an uncovered stent has proved successful successful proved has stent uncovered an of choice The The outcome of our treatment was the recanalization of of recanalization the was treatment our of outcome The The interest of the clinical case described is in the long- is in the described clinical case the of interest The The pediatric nasogastroscope allowed us to traverse traverse to us allowed nasogastroscope pediatric The Amplatz Super Stiff Super Amplatz 2013, no immediate or late complications were observed, observed, were complications late or 2013, immediate no 2013 – first late complication). complication). late 2013 –first immediate and late complications (from November 2008 2008 November (from complications late and immediate the rectum without performing the definitive , colostomy, definitive the performing without rectum the to June 2013), and the endoscopic APC treatment to to treatment APC endoscopic the and 2013), June to of absence the years), (five placement stent term the slow growth of neoplastic tissue occurred (after five five (after occurred tissue neoplastic of growth slow the the upstream part; it also allowed the positioning of an an of positioning the also allowed it part; upstream the in colonoscopy the allowing angle, thereby the reduce to helped and lesion, the of length the measure stenosis, the of treatment favoring endoscopy and not surgery, favoring and endoscopy surgery, not treatment of choice The and surgeon oncologist. endoscopist, colostomy was a positive factor in the patient’s patient’s the in factor apositive was colostomy years), it was treated with a minimally invasive a minimally invasive with treated was it years), up to and including intestinal disorders. disorders. intestinal including and to up general condition. Not having a permanent having a Not permanent general condition. OUTCOME /POST-PROCEDURE CONCLUSION otherwise indispensable, with the risk of neoplastic neoplastic of risk the with indispensable, otherwise endoscopic technique (APC). technique endoscopic quality of life, both clinically and psychologically. and clinically both life, of quality direct endoscopic vision and radiologic control. radiologic and vision endoscopic direct demonstrates an optimal synergy among among synergy optimal an demonstrates carcinomatosis. From initial stent placement until June June until placement initial stent From carcinomatosis. peritoneal massive the to due implants cutaneous resolve neoplastic infiltration within the stent (June (June stent the within infiltration neoplastic resolve In our experience, the clinical case described described case clinical the experience, our In neoplastic stenosis without its dislocation, and when when and dislocation, its without stenosis neoplastic because it allowed the stent’s placement in the in the placement stent’s the allowed it because patient lived for about five years in fairly good good fairly in years five about for lived patient tumor enabled palliation of the obstruction. The The enabledtumor palliation obstruction. the of the of biology the and treatment chemotherapy the ™ Guidewire 70cm above, under under above, 70cm Guidewire Rome, Digestive EndoscopyUnit Department ofSurgery“P. Valdoni” Policlinico UmbertoI University ofRomeLaSapienza ANTONIETTA LAMAZZA,M.D. CASE PRESENTEDBY: ITALY

5 4 3 2 1 GASTROENTEROLOGY 15 5

(UAMS) Direct ™ access

4 RAYBURN F. REGO, M.D. F. RAYBURN and AssociateDirector of Advanced Endoscopy Professor of Medicine and HepatologyDivision of Gastroenterology Department of Medicine Medical Sciences University of Arkansas for Little Rock, Arkansas, USA With the use of SpyGlass System technology, we and the patient was referred for surgery. Based on the 3 non-metastaticand operable, andwhen thepatient’s overall life expectancywould be greater than otherwise expected with pancreatic adenocarcinoma. Therefore, we late-detected margins absentlymphovascular or perineural invasion)there were strongly suggest use of this available tool in detailed patient was then started on Gemcitabine chemotherapy which he pancreatectomywith splenectomyMay post-in and well 2012 did was seen the in head, the patient was deemed not a suitable candidatefor subtotal . He underwent totala were able to detect pancreatic cancer at a stage when it was did notdid tolerate beyond one cycle. Since then he being is followed by (Figure 5) operatively. The pathology of the resected tissue confirmed a focal CONCLUSION CONCLUSION OUTCOME OUTCOME IPMN with extensive high-grade dysplasia. and has remained metastasis and/or recurrence free. aboveresults and thefact that of 1.5cm < the normal pancreatic duct abnormalities. abnormalities. strict surveillance with a positron emission tomography/CT protocol examination of abnormal pancreatic ducts.examination tumor was ascertained based on the fact that the tumor was limited tothe pancreas (with the invasive portion being < 2cm withnegative invasivemucinous adenocarcinoma arising in the background of Visualization System examination of highly suspicious pancreatic ductal 29negative lymph nodes and there was no distant metastasis. The The tumor size could not be assessed but pathological staging of a T1 This unique case illustrates the importance of the SpyGlass The pancreatic fluid CEAlevel was < 5 ng/ml withhigh DNA quantity. The SpyBite Biopsy Forceps pathology raised suspicion of dysplasia .

(UAMS) (Figure 2) , revealing , but no mucus 2 (Figure 3) Access and Delivery ™ . (Figure 1) (Figure 4 ) CASE PRESENTED BY: CASE PRESENTED BY: MOHIT GIROTRA, M.D. Fellow Gastroenterology and Hepatology and Hepatology Division of Gastroenterology Department of Medicine Medical Sciences University of Arkansas for Little Rock, Arkansas, USA 1 Biopsy Forceps Forceps Biopsy ™ branches with extensive material filling suspicious of mucus PROCEDURE PATIENT HISTORY HISTORY PATIENT mass or cyst was noted and the rest of the CT was unremarkable. normal and he was treated for constipation, which relieved his possible intraductal papillary mucinous neoplasm (IPMN). The pancreaticogram showed the dilated pancreatic duct and side Pancreatic fluid was aspirated for molecular analysis and carcinoembryonic antigen (CEA). A SpyScope was seen extruding from it. Nevertheless, it raised concern for a renal and liver function tests, amylase 49 IU/L, lipase 29 IU/L, IgG4 which confirmed the CT findings did and not reveal any mass/cyst. completely asymptomatic and denied any weight changes or appetite with a dilated pancreatic duct from the neck distally toward the tail, withdilated branches side but a normal duct the in head. Noobvious level 23 mg/dL, and < 0.8 CA19-9 U/ml. An MRCP was obtained loss. The laboratory work up revealed a normal hemogram, normal using the SpyBite abdominal pain radiating to the back. laboratory His workup was verythick globs of mucusMultiple . random biopsieswere obtained any past history of pancreatitis abdominalpain, or was similar seenby primarya care physician March in for 2012 upper-mid Catheter was used to access the pancreatic duct symptoms partially. A CT scan showed pancreas his was atrophic Inconspicuous IPMN Lesion IPMN Inconspicuous Cancer Nidus in a Patient with Patient with Nidus in a Cancer Early Detection of Pancreatic of Pancreatic Detection Early An ERCP showed a fish-mouthed ampulla A 50-year-old man with hypertension and hypercholesterolemia was The patient was referred to us for further management. He denied GASTROENTEROLOGY They then placed a plastic stent. He underwent a (without stone stone (without acholecystectomy underwent He stent. aplastic placed then They 16 Difficult StoneManagement Direct Visualization Systemfor Usefulness oftheSpyGlass Thanks to the SpyGlass System in combination with holmium laser, we were were we laser, holmium with combination in System SpyGlass the to Thanks Sometimes it is not easy to capture the stone with a basket so we use external lithotripsy lithotripsy external use we so abasket with stone the capture to easy is not it Sometimes inflammation. the first ERCP, physicians performed a sphincterotomy and partially removed the stones. stones. the removed partially and sphincterotomy a ERCP, performed first physicians the cholangiography showed the results stent, we confirmed the presence of two stones; the biggest one (13mm) was was in a one (13mm) biggest the stones; two of presence the confirmed we stent, plastic the of removal and cholangiography After it. remove and vision direct under stone stone that was difficult to remove using a basket or extraction balloon. The patient again patient The balloon. extraction or basket using a remove to difficult was that stone able to easily treat the patient and completely remove the stones. The final final The stones. the remove completely and patient the treat easily to able We introduced the SpyGlass System over-the-wire that easily allowed direct visualization visualization direct allowed easily that over-the-wire System SpyGlass the We introduced In December 2013, the patient was assigned to our hospital and we performed an ERCP ERCP an performed we and hospital our to assigned was patient 2013, the December In his cystic clogged that a13mm stone with male a60-year-old treated we case, this In CONCLUSION ANDPATIENT OUTCOME of the stone stone the of on the stones. In this way, it is easier to destroy and remove the stones, managing managing stones, the remove and destroy way, to this In is easier it stones. the on stone’s surface. the on directly energy the apply to in order laser or only the standard techniques (sphincterotomy and extraction devices). extraction and (sphincterotomy techniques standard the only and number the to due difficulties often are there procedures, choledocholithiasis During (Figures 4 and 5) 4and (Figures 3) (Figure. difficult position, clogging the cystic duct, without proximal common bile duct dilation or dilation bileduct common proximal without duct, cystic the clogging position, difficult laser therapy under vision. This allowed us to obtain a partial stone fragmentation fragmentation stone apartial obtain to us allowed This vision. under therapy laser duct after a cholecystectomy acholecystectomy after duct difficult choledocholithiasis procedures in the best way. best the in procedures choledocholithiasis difficult lithotripsy electrohydraulic of use the be can option Agood wave’s energy. the decrease By using the SpyGlass Direct Visualization System, holmium laser can be applied directly directly applied be can holmium laser System, Visualization Direct SpyGlass the using By with the SpyGlass the with complained of cholangitis, so he underwent a third ERCP without success. without ERCP athird underwent he so cholangitis, of complained abig detected that ERCP asecond and caliber) bile duct common athin to due removal previous endoscopic retrograde cholangiopancreatography (ERCP) procedures. During During procedures. (ERCP) cholangiopancreatography retrograde endoscopic previous position of stones. In these types of cases, it is not possible to remove the stones using using stones the remove to possible is not it cases, of types these In stones. of position PROCEDURE PATIENT HISTORY (extracorporeal shock wave lithotripsy); however, this technique can also be influenced influenced also be can technique this however, lithotripsy); wave shock (extracorporeal by the position of the stone or the presence of fluid around the stones. These factors may may factors These stones. the fluidaround of presence the or stone the of position the by the hospital the day after the procedure. procedure. the day the hospital after the access , making it easier for us to remove the fragments later with a basket abasket with later fragments the remove to us for easier it , making (Figure 2) (Figure . ™ Direct Visualization System and holmium laser in order to destroy the the destroy to in order holmium laser and System Visualization Direct . Using the SpyGlass System, we were able to perform holmium perform to able were we System, SpyGlass the . Using (Figure 1) (Figure . In another hospital, the patient underwent three three underwent patient the hospital, another . In (Figure 6) (Figure . The patient was discharged from from discharged was patient . The

Piemonte, Santi CroceeCarleHospital,Cuneo LUIGI GHEZZO,M.D. CASE PRESENTEDBY: ITALY 2 1 3 6 5 4 GASTROENTEROLOGY

. 17 5

. (Figure 4) (Figure 5) access

4 PATRICK BRADY, M.D. BRADY, PATRICK Division of Digestive Diseases University of South Florida FL, USA Tampa, 3 refractory gastrocutaneous fistulas and is a promising butresults increased in morbidity and mortality, especially in DISCUSSION revealed four place in clips and persistent closure of theGCF closure of the fistula opening. This case illustrates that Refractory gastrocutaneous fistulas are a known consequence debilitated patients. and excision of the fistulous tractis often required Endoscopic of GCFs clipping involves grasping the mucosal and Endoscopic evaluation four months after endoscopic placement clip following gastrostomy removal that can be very difficult to manage. one clip in place in one with clip a well-healed gastric mucosa OUTCOME approximating the opposite thus walls, leading to macroscopic alternative to surgery. submucosal tissue layers at the fistulous tract edges and Conservative management of GCFs has had limited success. Surgical endoscopic placement clip is a valuable modality for closing A repeat months EGD 16 after endoscopic placement clip revealed

­ . The. Clip to Clip ™ (Figure 1) 2 resulting immediate in closure of the CASE PRESENTED BY: CASE PRESENTED BY: D.O. J. KOLKHORST, KIMBERLY Division of Digestive Diseases University of South Florida FL, USA Tampa, (Figure 3) 1 . Attempted closure of the fistulainternal using and (Figure 2) PROCEDURE PATIENT HISTORY PATIENT have a severe proximal radiation-induced stricture. A percutaneous radiological gastrostomy (PRG) was subsequently placed to improve nutrition. post-neck radiation and total laryngectomy approximately 20 years prior), presented with complaints of dysphagia and was found to persisted. An EGD was repeated one week later with placement of removedmonths 10 after placement. Fourteen days after PRG removal the patient was noted to have persistent leakage from a 8mm gastrocutaneous fistula (GCF) at prior gastrostomy gogastroduodenoscopies (EGD) with via dilation the Tucker gastrostomyup to Successful 38 Fr. Savary was dilation eventually gastrocutaneous fistula. fistula. gastrocutaneous decreased fistula output was noted after placementclip butleakage external interrupted sutures silk was unsuccessful. EGDrevealed the a hole in anteriorof thewall stomach, approximating achieved was dilation no and longer Tucker required. The PRG was approximate the margins of the fistulous tract was performed. A Over the course months, of 17 the patient underwent esopha 18 five endoscopic clips Tucker Dilation via Gastrostomy Dilation Tucker in a Patient with History of with in a Patient of a Gastrocutaneous Fistula Fistula of a Gastrocutaneous Endoscopic Clip Closure Closure Clip Endoscopic An EGD with endoscopic placement clip using one Resolution A 56-year-old female with a history of laryngeal cancer (status GASTROENTEROLOGY 18 Dissection after EndoscopicSubmucosal to CloseDuodenalPerforation Resolution ClipDevicesUsed access 1 The Sensation The This case demonstrates the usefulness of Resolution Clip Devices in the closure of luminal perforations of the the of luminal of perforations closure in the Clip Devices Resolution of usefulness the demonstrates case This The pathology of the removed lesion showed complete excision of the carcinoid tumor. The patient was discharged discharged was patient tumor. The carcinoid the of excision complete showed lesion removed the of pathology The mucosal the to cautery superficial applying by marked was duodenum in the bulge endoscopic the of border The A 56-year-old man was found to have a 10mm subepithelial lesion in the junction between the first and second part of part second and first the between junction in the lesion a10mm subepithelial have to found was man A 56-year-old two days post procedure. Repeat upper endoscopy three months after the resection showed a well epithelialized scar scar a well epithelialized showed resection the after months three endoscopy upper Repeat procedure. post days two identified was perforation duodenal tumor, a5mm carcinoid the the duodenum when undergoing an upper endoscopy to screen for Barrett’s esophagus. He had a history of diabetes diabetes of ahistory had He esophagus. Barrett’s for screen to endoscopy upper an undergoing when duodenum the surface. A solution of 1:10,000 epinephrine and methylene blue was injected into the submucosa. Using cap cap Using submucosa. the into injected blue was methylene and epinephrine 1:10,000 of Asolution surface. assistance, a submucosal dissection was carried out around the carcinoid tumor. Upon dissecting the proximal end of of end proximal the dissecting tumor. Upon carcinoid the around out carried was dissection asubmucosal assistance, a 10mm hypoechoic lesion in the submucosa consistent with a duodenal carcinoid carcinoid aduodenal with consistent submucosa in the lesion a 10mm hypoechoic after the perforation was identified. Unfortunately, the intraluminal air began to enter the peritoneal space and and space peritoneal the enter to began air intraluminal the Unfortunately, identified. was perforation the after OUTCOME ANDPOST-PROCEDURE full distension of the duodenum could not be achieved. We then applied two Resolution two applied We then achieved. be not could duodenum the of full distension duodenum. duodenal perforation and this re-established retention of intraluminal air. An additional five Resolution Clip devices Clip devices Resolution air. five intraluminal of additional An retention re-established this and perforation duodenal with no recurrence of tumor tumor of recurrence no with were then used to close the remaining 2.5cm mucosal defect defect mucosal 2.5cm remaining the close to used then were requiring a more extensive resection, he was referred for endoscopic submucosal dissection. submucosal endoscopic for referred was he resection, extensive amore requiring mellitus that was controlled with oral hypoglycemic agents. A radial endoscopic ultrasound was performed showing showing performed was ultrasound endoscopic Aradial agents. hypoglycemic oral with controlled was that mellitus Resolution Clip to close the perforation during the endoscopy, the patient was able to avoid surgery. surgery. avoid to able was patient the endoscopy, the during perforation the close to Clip Resolution PROCEDURE PATIENT HISTORY biopsies confirmed carcinoid tumor cells. Because of the potential risk of metastatic disease and the possibility of possibility the and disease metastatic of risk potential the of cells.Because tumor carcinoid confirmed biopsies to take the opposing sides of the luminal perforation and to provide an adequate seal. By utilizing the the utilizing By seal. adequate an provide to and perforation luminal the of sides opposing the take to The initial two Resolution Clip Devices with their wide jaws and closing pressure were able able were pressure closing and jaws wide their with Devices Clip Resolution two initial The ™ Single-Use 30mm Oval Polypectomy Snare was then used to resect the carcinoid tumor immediately immediately tumor carcinoid the resect to used then was Snare Polypectomy Oval 30mm Single-Use 2 (Figure 5) (Figure . 3 (Figure 4) (Figure (Figure 3) (Figure . Vancouver, BritishColumbia,CANADA University ofBritishColumbia Division ofGastroenterology Clinical AssociateProfessor ERIC C.S.LAM,M.D.,FRCPC CASE PRESENTEDBY: . 4 (Figures 1 and 2) 1and (Figures ™ Clip devices to the 5mm 5mm the to Clip devices . Endoscopic . Endoscopic 5 GASTROENTEROLOGY 19

During 4 .

access

(Figure 7) 7 Queen Elizabeth II Jubilee Hospital Queen Elizabeth Brisbane, AUSTRALIA CASE PRESENTED BY: BY: PRESENTED CASE MSC, PH.D., FRACP MBBS, G. HEWETT, DAVID Associate Professor, Queensland School of Medicine University of (Endoscopy),Deputy Director 3 6 be avoided (to encourage generous tissue capture within the clip). PATIENT OUTCOME PATIENT Resolution Clip Devices are effective tools for closure of patient was admitted to hospital for observation ondiet. a clear fluid with an en bloc resection of >20mm serrated lesions warranted is within to the tightly clip apposethe defect achieve margins. To closure, one arm of the can be clip used to grasp and lift normal resection without serosa. Follow-up colonoscopy at four months remaining embeddedclip within the scar despite large volume submucosal injection and careful technique. discharged within hours. 24 Histology confirmed muscularis propria demonstrated complete resection of neoplastic tissue, with a single endoscopic resection, recognition of muscularis propria injury is CONCLUSIONS and the mucosal defect for target/mirror target essential. signs is Caution Intraprocedural intravenous antibiotics were administered, and the abdomen excluded thickness full perforation, and the patient was side ofside the defect (again grasping a generous amount of normal simultaneous down angulation of the instrument tip. Excessive endoscopic perforationsendoscopic injury. muscle deep and tissue before then angulating the other arm into position on other tissue). Gentle application of suction can bring help the margins advancingtogether, while minimally the catheter, often with tension on the colon from wall forward advancement of should the clip important, and careful inspection of the base of the specimen (in vivo) The patient reported no post-procedure abdominal pain. A CT of the

2 (Figures 5 ). 5 , resected specimen Clip Devices Clip ™ Figure 1 Figure 4 1 , mirror target sign), with corresponding Figure 3 following a submucosal injection of succinylated (Figure 2) . A totalA were. clips applied of sequentially 16 from one of side by indigocarmine-stained blue submucosal tissue). PROCEDURE PATIENT HISTORY AND ASSESSMENT HISTORY PATIENT propria was evident ( evident was propria colonoscopy for endoscopic resection of the large proximal colon clearance of serrated lesions. Indigocarmine dyespray cap-fitted colonoscopy was used to facilitate detection, and a large sessile large concentric defect (approximately the in muscularis 10-15mm) gelatin (Gelofusine) mixed with indigocarmine (80mg in 500mL of thickness full perforation. ex-vivo, with a central white of disk muscularis propria surrounded and6) attempted attempted achieve a satisfactory position and acquire sufficient normal tissue Colonoscopic resection of the 25mm sessile serrated adenoma at solution),and using electrocautery (ERBE Vio 300D, EndocutQ effect sessile serrated adenomas. This was her second colonoscopy for serrated adenoma/polyp (SSA/P) was identified at the hepatic 3). Carbon dioxide used is routinely for insufflation. After resection, a target on sign the resected specimen ( the hepatic flexure was performed. An en bloc resection was the defect to the other a “zipper” in fashion. Each was placed clip immediately adjacent to the last to ensure complete closure case in Sequential closure required clip careful maneuvering of each to clip flexure (Parisclassification 0-IIa, 25mm, of a Large Serrated Polyp Serrated of a Large during Colonoscopic Resection Resection Colonoscopic during of Muscularis Propria Injury Injury Propria of Muscularis Resolution Clip Devices Closure Closure Devices Clip Resolution A 64-year-old female with serrated polyposis syndrome underwent a The defect was closed using Resolution GASTROENTEROLOGY Two days after the procedure, the patient presented to the emergency emergency the to presented patient the procedure, the after Two days A 61-year-old male with past medical history significant for for significant history medical past with male A 61-year-old 20 the ResolutionClipDevice Post-polypectomy Bleedingwith Immediate andDelayed Successful Managementof 20cc total) was injected at the site followed by deployment of eight eight of deployment by followed site the at injected was total) 20cc 2.5cm resection site also was accomplished. Complete hemostasis hemostasis Complete accomplished. also was site resection 2.5cm Since the stalk was very short and broad based, the base of the the of base the based, broad and short very was stalk the Since injected into the bleeding area and two additional clips were placed placed clips were additional two and area bleeding the into injected to ensure clear margins, and was submitted separately to pathology. to separately submitted was and margins, clear ensure to small amount of persistent bleeding from the arterial site where one one where site arterial the from bleeding persistent of small amount saline injection and was resected with snare cautery cautery snare with resected was and saline injection an arterial vessel in the polypectomy base. Epinephrine (1:10,000 x Epinephrine base. polypectomy in the vessel arterial an from seen was bleeding brisk significant post-resection, Immediately at the site of bleeding with complete hemostasis at the end of the the of end the at hemostasis complete with bleeding of site the at admitted for overnight observation. He remained stable with no no with stable remained He observation. overnight for admitted endoclips at the site of arterial bleeding (slightly less than 2mm) was was 2mm) than less (slightly bleeding arterial of site the at endoclips endoclips were still in place and there was no bleeding from those those from bleeding no was there and still in place were endoclips further bleeding and he was discharged home the following day. following the home discharged was he and bleeding further He was hemodynamically stable. Flexible sigmoidoscopy revealed a revealed sigmoidoscopy Flexible stable. hemodynamically was He Resolution done to achieve hemostasis and approximation of the edges of the the of edges the of approximation and hemostasis achieve to done was achieved at the end of the procedure procedure the of end the at achieved was clip appeared to have been dislodged dislodged been have to clip appeared 31. to 34 from dropped had His hematocrit hematochezia. with room was resected in a piecemeal manner, in antegrade and retroflexed retroflexed and manner, in antegrade in apiecemeal resected was polyp the and polyp the of base the at deployed was endoloop An colon. ashort, on polyp 5cm approximately An snare. ahot using colon transverse and ascending the from retrieved and resected were polyps 5-6mm eight colonoscopy, During risk). (average colonoscopy parts of the polypectomy site. Epinephrine (1:10,000 x 10 cc) was was (1:10,000 x10 cc) Epinephrine site. polypectomy the of parts polyp with the stalk was resected with the snare below the endoloop endoloop the below snare the with resected was stalk the with polyp positions. The polyp base was then elevated with a submucosal asubmucosal with elevated then was base polyp The positions. hypertension and diabetes mellitus was referred for screening screening for referred was mellitus diabetes and hypertension POST PROCEDUREFOLLOWUP PATIENT HISTORY ANDPROCEDUREDETAILS broad-based stalk measuring about 1.5 cm was seen in the sigmoid in the 1.5 seen was about cm measuring stalk broad-based access ™ Clip Devices Clip Devices 1 (Figure 2) (Figure . Direct application of the the of application . Direct (Figure 4) (Figure (Figure 3) (Figure 2 . The patient was was patient . The . The remaining remaining . The (Figure 1) (Figure . site or on surveillance biopsies of the healed polypectomy site site polypectomy healed the of biopsies surveillance on or site site. anticoagulation. on patients or vessels, blood exposed with sites arterial bleed with the use of the Resolution Clip Device. Clip Resolution the of use the with bleed arterial When bleeding is encountered after resection of a pedunculated apedunculated of resection after is encountered bleeding When and no recurrence or residual adenoma was seen at the resection resection the at seen was adenoma residual or recurrence no and Afollow-up margins. clear with resected completely adenoma, Immediate post-polypectomy bleeding can occur in up to 1.5 in to up 3 to occur can bleeding post-polypectomy Immediate In our practice, we are placing endoclips for hemostasis when we we when hemostasis for endoclips placing are we practice, our In feel there is an elevated risk of post-polypectomy bleeding. This could could This bleeding. post-polypectomy of risk is elevated an there feel minimize to resection to prior polyp apedunculated of stalk the of (Figure 5) (Figure colonoscopy was performed three months after the initial procedure initial procedure the after months three performed was colonoscopy resection site in high risk situations, but the benefit of doing that has has that doing of benefit the but insituations, high risk site resection the of edges the approximate to placed be clips can Additional case. above in as the site, bleeding the over directly placed clip be can bleeding. post-polypectomy of risk vessel, ulceration at the site and possible clip displacement clip displacement possible and site the at ulceration vessel, procedure. The patient remained stable with no further episodes of of episodes further no with stable remained patient The procedure. site of the bleeding vessel. Our case illustrates successful successful illustrates case Our vessel. bleeding the of site the at endoclips additional of placement with successfully polypectomy the at ulceration from occur can bleeding polypectomy durable help achieve can stalk the aclip placing across polyp, base the across placed clip be can The bleeding. post-polypectomy manage to used increasingly being are Endoclips cases. of percent not been studied in a randomized trial design. Delayed post- Delayed design. trial in arandomized studied been not the polyps, sessile of resection after bleeding of case In hemostasis. DISCUSSION bleeding. Pathology revealed the lesion to be a tubulovillous atubulovillous be to lesion the revealed Pathology bleeding. be patients with other co-morbidities and/or coagulopathy, defect defect coagulopathy, and/or co-morbidities other with patients be led to recurrent bleeding. However, this was managed managed was this However, bleeding. recurrent to led management of immediate and delayed post-polypectomy and delayed immediate of post-polypectomy management In our patient, the relatively large caliber of the bleeding bleeding the of caliber large relatively the patient, our In 3 . 4 Rochester, NY, USA Medical Center University ofRochester Therapeutic Endoscopy Center ForAdvanced VIVEK KAUL,M.D.,FACG SHIVANGI KOTHARI,M.D. CASE PRESENTEDBY:

5 GASTROENTEROLOGY 21

(Figures 5 access

PLUSRotatable Retrieval Device was ® CASE PRESENTED BY: BY: CASE PRESENTED M.D., FRCPC CHALMERS-NIXON, TARA Professor Clinical Assistant Hospital Rockyview Calgary, University of CANADA Alberta, Calgary, . The polyps were then sent for pathology. The the polyp and retrieve it properly, the patient may helpful in using of all these Boston Scientific be sure no additional polyps were missed. have had to have a resection of the area where the polyp was. bleedingas discussed during followup more his than 14 may have helped place the net over the polyps. patient scheduled is for a follow-up colonoscopy within pathology and lifting saline of the largest polyp, and to polyp tissue through the netting. (or The ‘spine’ third polyps were removed successfully during this single procedure.He had not experienced any post-polypectomy performing a good-quality colonoscopy. Being able to Proper polypectomy removal and retrieval critical is to Information and in-services for the physicians was easy to use and there was excellent visibility of the wire) the in TWISTER PLUS Rotatable Retrieval Device devices in appropriate in devices situations. dayspost procedure. The largest polyp was a villous depression, etc. Had it not been possibleto remove for the removal of both one in withdrawal Next, a TWISTER used to grab both of the large polyps together and remove CONCLUSION OUTCOME adenoma with high-grade dysplasia but no cancer. The and 6) around the two polyps without crushing them, allowing and nurses very endoscopy been our unit have in second polyp smaller was a tubulovillous adenoma. The sendthe polyp for pathological examination determines two weeks to be sure of complete removal given the size, them. The TWISTER PLUS Rotatable Retrieval Device fit the case of large polyps with worrisome features such as the one identified in this case: greater1cm, centralthan if the patient not or need will will resection, especially in TWISTER PLUS Rotatable Retrieval Device retrieval net The patient tolerated the procedure the and well all

™ ™ . The . It was . (Figure 1) (Figure 2) (Figure 4) Clip Devices. Clip . As such, I felt that hemostasis was ™ (Figure 3) bowel habits and abdominal discomfort. past His PROCEDURE PATIENT HISTORY PATIENT monitoringequipment. Usingvideoa colonoscope,the medical history was significant for obesity,diabetes, hypercholesterolemia, hypertension and hypothyroidism. hypothyroidism. hypertension and hypercholesterolemia, prepared with only remaining. clear A 2.5cm liquid polyp polyp was then removed using a large oval Captivator with a central depression was identified 5cmdistal to the complaints were most a result likely of medication side rotation of was the needed clip colon removedone in piece. The polypectomysite was clean required and decided to close the post-polypectomy wasgood a in position, so the deployed clips very well without any torque applied to thescope, and very little was identifiedjust distal to the firstpolypectomy, so it was removed with also a snare cautery. were Clips not Before this polyp was retrieved, a second cm polyp 1.0 goal was to remove the polyp en bloc. Using an Interject defect (approximately2cm length in and 5-6mm wide) difficulty close to the defect. The actual polypsite He previously had a cholecystectomy. Although his further. This was the patient’s first colonoscopy. effects, a colonoscopy was recommended to investigate fentanyl 50 and mcg monitored IV, with the appropriate using Resolution and not bleeding, but rather large and the in proximal InjectionTherapy NeedleCatheter the polyp was lifted and injected with 10cc of normal saline applied tothis second site. Both polyps were then sitting scope was advanced to the The ileum. bowel was well specific gastrointestinal complaints, includingirregular ileocealvalve. Because of concern forthe malignancy, in thein lumen of the bowel. Single UseSingle Snare with cautery applied The patient was sedated with midazolam 5mg and The patient was a 55-year-old malereferred for non- Three Resolution Devices Clip were placed without 6 5 4 3 2 1 Retrieval Device Retrieval and TWISTER PLUS Rotatable Rotatable PLUS and TWISTER Needle, Captivator Snare Captivator Needle, Polypectomy Using the Interject the Interject Using Polypectomy News and New Devices

› WallFlex ™ RX Biliary Stents are now available in Europe in 10cm and 12cm lengths. The new stents will enable physicians to provide better treatment options for clinical indications, including anastomotic liver transplant strictures, altered anatomy and hilar strictures.

WARNING: The safety and effectiveness of the WallFlex Biliary Stent for use in the vascular system has not been established.

› DirecTip™ Technology is what gives the Autotome™, TRUEtome™ and other Boston Scientific Cannulating Sphincterotomes their center-lumen design, allowing the guidewire to extend from the center of the sphincterotome to aid in positioning, and facilitate wireguided cannulation. DirecTip Technology enables the guidewire and contrast to be directed into the duct from the center of the tip, helping the physician inject contrast into the intended duct.

› Expect™ Slimline (SL) Needle for EUS FNA procedures offers a smaller handle profile and a smooth, low-friction gliding mechanism utilized during tissue sampling. The Control ZONE™ on its handle has two ergonomically defined areas to optimize control during the actuation motion and to accommodate different hand sizes and techniques. All Expect Needles have a sharp needle grind and highly visible echogenic pattern, providing precise guidance and helping to maintain tip visibility. Gauge sizes are 19, 19Flex, 22 and 25 for both the Expect and Expect SL Needles.

As Seen In

Online Global Resources For the latest news and information from Boston Scientific Endoscopy, visit www.bostonscientific.com/endo-resources

ACCESS Magazine was produced in cooperation with several physicians. The procedures discussed in this document are those of the physicians and do not necessarily reflect the opinion, policies or recommendations of Boston Scientific Corporation or any of its employees. Results from case studies are not predictive of results in other cases. Results in other cases may vary. Indications, Contraindications, Warnings and Instructions for Use can be found in the product labeling supplied with each device. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. WARNING: The safety and effectiveness of the WallFlex Biliary Stent for use in the vascular system has not been established. Autotome, Advanix, Captivator, Control ZONE, CRE, DirecTip, Dreamwire, EndoVive, Expect, Jagwire, Interject, Resolution, Sensation, SpyBite, Spyscope, SpyGlass, WallFlex, and WALLSTENT are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. All other trademarks are property of their respective owners. TWISTER® PLUS is a trademark of Horizons International Corp. Distributed by Boston Scientific Corporation, Natick, Massachusetts; manufactured by Horizons International Corp., Heredia, Costa Rica. ©2014 Boston Scientific Corporation or its affiliates. All rights reserved. DINEND2329EA ENDO-236105-AA April 2014