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634 Current Designs of Self-Expanding Stents
Fig. 4.18 Self-expanding plastic stent (Poly fl ex) with capture basket for loading into the delivery system ( arrowheads )
Bowel
Enteral stents are traditionally placed without covering membrane as the migration rate of cov­ered stents is very high. The risk of displacement in the colon is increased by the passage of feces. It is important that constipation is avoided, but there is no consensus whether a low-residue diet or a diet high in soluble fi ber is preferable. From a practical point of view, anything that keeps the patient regular must be a good thing, and stool­softening laxatives should be given routinely. Unfortunately, uncovered stents migrate less but occlude in almost 25%. Compound knitted stents, which sandwich a membrane between two layers of wire mesh, should be a good compromise, but initial outcome data are equivocal [
15, 38 ] . The
poor performance of laser-cut enteral stents how­ever con fi rms that fl exibility and conformability are a priority for enteral stents.
Bile Duct
Fig. 4.19 Esophageal stent with antimigration collar
(Ella-HV+)
Antire fl ux Stents
Stents placed with their lower end in the gastric fundus predispose the patient to re fl ux of gastric content. The fundus is the lowest part of the stomach in the supine position, and hydrostatic pressure will force gastric content through a stent into the mid and upper esophagus. This is readily demonstrated on CT scanning. Most esophageal stents are available with an antire fl ux valve (Fig. 4.22 ), but the clinical bene fi t of a valve is still controversial [ 31 ] . However, limited evi- dence suggests potential for a signi fi cant bene fi t, including reduced need for antire fl ux medication and prevention of aspiration pneumonia and fatal aspiration [ life [ Galway, Ireland) may be inserted into patients with an open stent who have troublesome regur­gitation of gastric content (Fig. 4.23 ) [ 37 ] .
5, 32– 35 ] and increased quality of
36 ] . A stand-alone retro fi t valve (Vysera,
The greatest variety of different designs are seen in biliary stents, including membrane-based stents and numerous laser-cut stents as spin-offs from vascular designs (Fig. 4.24 ). Due to the nature of their tubular design, alignment of laser­cut stents is inferior to woven stents (Fig. 4.25 ), and fractures are not uncommon. Stent occlusion requiring reintervention is increasingly required due to extended patient survival from improved chemotherapy regimes. This becomes particu­larly challenging if the existing stent does not conform to the biliary anatomy, and reinterven­tion is only possible through the side of the stent skeleton (Fig.
4.26 ). Care must be taken not to
become entangled in the sharp edges of a laser­cut stent.
Covered stents are available for the biliary tree, but these should be considered with great caution. There is a high risk of irreversibly occluding biliary side branches: the cystic duct or the pancreatic duct. In case of a pancreatic head cancer, a covered stent may be a good choice if this can be placed below the origin of the cystic duct. However, obstruction of this can lead to
64
Fig. 4.20 Esophageal stent with uncovered antimigration segment for mucosal ingrowth (Niti-S double)
H.-U. Laasch
Fig. 4.21 Migrated esophageal stent (Boubella) at ileo­cecal junction
Fig. 4.23 Antire fl ux valve for retro fi tting into an open stent. The silicone valve is mounted in a segment of uncov­ered nitinol stent, which requires loading into a standard esophageal stent delivery system (viewed from below)
Fig. 4.22 Stents with antire fl ux valves. ( a ) Dua (Cook); ( b ) Hanaro (MI-Tech); ( c ) Niti-S double (Taewoong); ( d ) Ella-HV (Ella-CS)
increasing dilatation of the gallbladder and chole­cystitis. The indiscriminate use of covered stents may result in unsalvageable occlusion of essen­tial segmental ducts (Fig. 4.27 ).
Tumors of the biliary hilum represent a particu­lar challenge. Skilled endoscopists will be able to place bilateral plastic stents in most cases, but these will occlude within 6–12 months. Larger-diameter
654 Current Designs of Self-Expanding Stents
Fig. 4.24 Biliary stents. ( a ) Ella-SX (braided); ( b ) Covered Wallstent (braided); ( c ) Luminexx (laser-cut); ( d ) PTFE membrane-based Viabil stent with nitinol struts
Fig. 4.25 Luminal patency within a tight bend is well maintained in a knitted ( a ) and braided stent ( b ), whereas the laser-cut stent ( c ) kinks
metal stents tend to give a better long-term result, but bilateral placement is dif fi cult endoscopically [ 39 ] . To allow stenting of both hepatic ducts through a single percutaneous approach, fenestrated stents are available, which allow initial placement from one hepatic duct to the other [ 40 ] , with a further stent inserted downstream through the window, resulting in a coaxial T-con fi guration (Fig. 4.28 ). An uncovered stent must be used for this; other­wise, the contralateral side is excluded.
(WL Gore, Flagstaff, AZ, USA); ( e ) T-stent for hilar stric- tures (Niti-S); ( f ) Bare and covered Egis (knitted)
Biodegradable biliary stents are not rou­tinely available, but custom-made devices have been used successfully for treatment of in fl ammatory biliary strictures [ 22 ] . They may play an important role in the future with the increasing numbers of liver transplantations and radical pancreaticoduodenectomies. At present, they are only available off-label with large delivery sheaths up to 13 French, which require very large transhepatic tracks and negate endoscopic insertion.
Delivery Systems
Designs for delivery systems have converged onto pullback systems, where the stent is released by withdrawing the constraining sheath. The only remaining exception is the Ultra fl ex system (Boston Scienti fi c) where the stent is tied down to the delivery system with loops of silk thread (Fig. 4.29 ). This unravels on traction like grandmother’s jumper. The dis­advantage is the large size and the very rough outer pro fi le of the system, which frequently necessitates predilatation of the stricture in
66
H.-U. Laasch
Fig. 4.26 Reintervention for occluded laser-cut stent (pancreatic carcinoma) ( a ) Coronal CT reconstruction shows a poorly aligned, blocked stent (Luminexx) in a dilated bile duct ( arrowheads ). The upper end is partially embedded in the roof of the bile duct ( arrow ). An enteral Wall fl ex stent is present in the duodenum. ( b ) Attempts at
Fig. 4.27 Occlusion of segmental ducts by placement of bilateral covered biliary stents. Percutaneous cholangiog­raphy shows holdup of contrast medium at the junction with the covered stent ( arrow ) (Courtesy of Dr. E. Bakir, North Manchester General Hospital, UK)
cannulation of the stent failed, and the second stent (Niti-S) could only be placed through the side ( arrow ) of the fi rst stent. The angulation of the laser-cut stent ( arrow- head ) indicates partial fracture. This became separated on follow-up CT (Courtesy of Dr. E. Bakir, North Manchester General Hospital, UK)
order to pass the stent. Pullback delivery systems for most metal esophageal stents measure 16–18 Fr (5–6 mm diameter) but can be consid­erably larger (e.g., Poly fl ex). A radiopaque ring at the end of the sheath reduces uncertainty about the degree of deployment. For resheathable stents, a marker indicating the point of no return is helpful. Increased control over the deployment process is offered by a pistol grip, where repeated pulling of the trigger slowly withdraws the sheath (Evolution, Cook); the process can be reversed to resheath the stent. It is available for esophageal, enteral, and biliary stents.
The tip of a large delivery system may impact in the deployed stent on withdrawal if the stent has not suf fi ciently expanded. A quirky delivery system for the early Ella-CS stents consisted of an angioplasty catheter, where the balloon formed the introducer tip. This was de fl ated prior to deployment, and impaction was completely avoided. It has now been replaced by a tip that sheds two parts of a plastic dilatation on release of the stent (Fig. 4.30 ). An interim design with a longer releasable tip was abandoned following a case of a perforated sigmoid diverticulum caused by impaction of the tip.
Fig. 4.28 ( a – c ) Single puncture approach to hilar tumors affecting both hepatic ducts. A fenestrated knitted T-stent is placed from right to left , followed by a woven stent through the window into the common duct (Both Niti-S)
674 Current Designs of Self-Expanding Stents
Fig. 4.29 Thread-release delivery system (Ultra fl ex precision). ( a ) Undeployed; ( b ) Part-deployed colonic stent
The DIY experience of loading the Poly fl ex system can be a challenge to the less playful operator. More importantly though, a balanced choice has to be made between the cost-savings of the stent against the large size and rigidity of the delivery system.
Some esophageal stents are available on a proximal release system for high strictures close to the upper esophageal sphincter (Fig. 4.31 ). Foreign body sensation increases above the upper margin of C7 vertebral body, and accurate
Fig. 4.30 Compound tip of Ella delivery system. Two plastic dilator cones automatically detach from the fl exible central tip on deployment. Note the metal marker ring on the distal end of the delivery sheath ( arrow )
positioning of the proximal end of the stent is essential in the cervical esophagus. The whole sheath is advanced distally and requires removal though the released stent. This requires suf fi cient
68
H.-U. Laasch
Fig. 4.31 Proximal release system (Ella-HV). The deliv­ery sheath pushes forward, releasing the stent from the top . It is removed through the deployed stent
length of guide wire below the stricture and adequate stent expansion for removal of the sys­tem through it.
Few differences between delivery systems for biliary and enteral stents exist; they are mainly limited to the presence of radiopaque markers and nitinol reinforcement of the constraining sheath.
Summary
An understanding of the properties of different stent designs is helpful in choosing the most appropriate stent for each situation, but depart­ments can only stock a limited supply. Better collaboration between scientists, industry, and clinicians is needed to change current trial-and­error development to purposeful optimization of designs. Ideally, this would involve mathematical modeling as well as a better understanding of stent behavior within the human body.
Acknowledgments The author would like to thank
BVM Medical, COOK UK, Ella-CS, and UK Medical for
their support with demonstration models and S&G Biotech for the provision of images from the manufactur­ing process.
References
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694 Current Designs of Self-Expanding Stents
14. Isayama H, Kawabe T, Nakai Y, et al. Management of distal malignant biliary obstruction with the ComVi stent, a new covered metallic stent. Surg Endosc. 2010;24:131–7.
15. Moon CM, Kim TI, Lee MS, et al. Comparison of a newly designed double-layered combination covered stent and D-weave uncovered stent for decompression of obstructive colorectal cancer: a prospective multi­center study. Dis Colon Rectum. 2010;53:1190–6.
16. Kim YW, Choi CW, Kang DH, et al. A double-layered (comvi) self-expandable metal stent for malignant gastroduodenal obstruction: a prospective multicenter study. Dig Dis Sci. 2011;56:2030–6.
17. Tanaka T, Takahashi M, Nitta N, et al. Newly devel­oped biodegradable stents for benign gastrointestinal tract stenoses: a preliminary clinical trial. Digestion. 2006;74:199–205.
18. Fry SW, Fleischer DE. Management of a refractory benign esophageal stricture with a new biodegradable stent. Gastrointest Endosc. 1997;45:179–82.
19. Zilberman M, Nelson KD, Eberhart RC. Mechanical properties and in vitro degradation of bioresorbable fi bers and expandable fi ber-based stents. J Biomed Mater Res B Appl Biomater. 2005;74:792–9.
20. Repici A, Vleggaar FP, Hassan C, et al. Ef fi cacy and safety of biodegradable stents for refractory benign esophageal strictures: the BEST (Biodegradable Esophageal Stent) study. Gastrointest Endosc. 2010;72:927–34.
21. Janik V, Horak L, Hnanicek J, Malek J, Laasch HU. Biodegradable polydioxanone stents: a new option for therapy-resistant anastomotic strictures of the colon. Eur Radiol. 2011;21(9):1956–61.
22. Petrtyl J, Bruha R, Horak L, Zadorova Z, Dosedel J, Laasch HU. Management of benign intrahepatic bile duct strictures: initial experience with polydioxanone biodegradable stents. Endoscopy. 2010;42(Suppl 2): E89–90.
23. Stivaros SM, Williams LR, Senger C, Wilbraham L, Laasch HU. Woven polydioxanone biodegradable stents: a new treatment option for benign and malignant oesophageal strictures. Eur Radiol. 2010;20:1069–72.
24. Laukkarinen J, Sand J, Leppiniemi J, Kellomaki M, Nordback I. A novel technique for hepaticojejunos­tomy for nondilated bile ducts: a purse-string anasto­mosis with an intra-anastomotic biodegradable biliary stent. Am J Surg. 2010;200:124–30.
25. Szegedi L, Gal I, Kosa I, Kiss GG. Palliative treat­ment of esophageal carcinoma with self-expanding plastic stents: a report on 69 cases. Eur J Gastroenterol Hepatol. 2006;18:1197–201.
26. Fukumoto R, Orlina J, McGinty J, Teixeira J. Use of Poly fl ex stents in treatment of acute esophageal and gastric leaks after bariatric surgery. Surg Obes Relat Dis. 2007;3:68–71, discussion 71–62.
27. Karbowski M, Schembre D, Kozarek R, Ayub K, Low D. Poly fl ex self-expanding, removable plastic stents: assessment of treatment ef fi cacy and safety in a variety of benign and malignant conditions of the esophagus. Surg Endosc. 2008;22:1326–33.
28. Ott C, Ratiu N, Endlicher E, et al. Self-expanding Poly fl ex plastic stents in esophageal disease: various
indications, complications, and outcomes. Surg Endosc. 2007;21:889–96.
29. Dua KS, Vleggaar FP, Santharam R, Siersema PD. Removable self-expanding plastic esophageal stent as a continuous, non-permanent dilator in treating refractory benign esophageal strictures: a prospective two-center study. Am J Gastroenterol. 2008;103: 2988–94.
30. Pennathur A, Chang AC, McGrath KM, et al. Poly fl ex expandable stents in the treatment of esophageal dis­ease: initial experience. Ann Thorac Surg. 2008;85:1968–72, discussion 1973.
31. Blomberg J, Wenger U, Lagergren J, et al. Antire fl ux stent versus conventional stent in the palliation of dis­tal esophageal cancer. A randomized, multicenter clinical trial. Scand J Gastroenterol. 2009;45:208–16.
32. Nunes CC, Waechter FL, Sampaio JA, Pinto RD, Alvares-Da-Silva MR, Pereira-Lima L. Comparative post-operative study of prostheses, with and without an anti-re fl ux valve system, in the palliative treatment of esophageal carcinoma. Hepatogastroenterology. 1999;46:2859–64.
33. Osugi H, Lee S, Higashino M, et al. Usefulness of self-expandable metallic stent with an antire fl ux mechanism as a palliation for malignant strictures at the gastroesophageal junction. Surg Endosc. 2002;16: 1478–82.
34. Homs MY, Wahab PJ, Kuipers EJ, et al. Esophageal stents with antire fl ux valve for tumors of the distal esophagus and gastric cardia: a randomized trial. Gastrointest Endosc. 2004;60:695–702.
35. Wenger U, Johnsson E, Arnelo U, Lundell L, Lagergren J. An antire fl ux stent versus conventional stents for palliation of distal esophageal or cardia can­cer: a randomized clinical study. Surg Endosc. 2006;20:1675–80.
36. Power C, Byrne PJ, Lim K, et al. Superiority of anti­re fl ux stent compared with conventional stents in the palliative management of patients with cancer of the lower esophagus and esophago-gastric junction: results of a randomized clinical trial. Dis Esophagus. 2007;20:466–70.
37. Hirdes MM, Vleggaar FP, Laasch HU, Siersema PD. Technical feasibility and safety of a new, implantable re fl ux control system to prevent gastroesophageal re fl ux in patients with stents placed through the lower esophageal sphincter (with video). Gastrointest Endosc. 2012;75(1):174–178.
38. Park S, Cheon JH, Park JJ, et al. Comparison of ef fi cacies between stents for malignant colorectal obstruction: a randomized, prospective study. Gastrointest Endosc. 2010;72:304–10.
39. Saleem A, Baron TH, Gostout CJ. Large-diameter therapeutic channel duodenoscope to facilitate simul­taneous deployment of side-by-side self-expandable metal stents in hilar cholangiocarcinoma. Gastrointest Endosc. 2010;72:628–31.
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Part 3
Overview of Available Prostheses
Esophageal Prostheses
Massimo Conio and Antonella De Ceglie
5
Self-expandable metal stents (SEMS) represent a major breakthrough in the endotherapy fi eld. Esophageal SEMS have acquired a pivotal role in palliation of malignant dysphagia due to esophageal-esophagogastric junction cancers (EC-EGJC) and mediastinal malignancy. Newly available SEMS have been proven safe and effec­tive in relieving such distressing symptoms [ 1– 3 ] to include dysphagia and chest pain. SEMS improve the quality of life (QoL) of these patients, allowing better nutrition intake which prevents dehydration and aspiration [ 4– 6 ] .
Recanalization of the esophageal lumen can be also achieved by other methods such as laser, argon plasma coagulation, and brachyradiother­apy with or without chemotherapy [ 7, 8 ] . However, chemoradiation therapy alone, as pri­mary treatment, can improve dysphagia but requires several weeks. Randomized trials have shown similar ef fi cacy for SEMS and brachyther­apy with the consistent result that dysphagia improved more rapidly after stent placement, but the duration of relief was longer after brachytherapy [
M. Conio , M.D. () Department of Gastroenterology and Digestive Endoscopy , General Hospital Sanremo , C.so Garibaldi 187, 3 , Sanremo (IM) 18038 , Italy e-mail: mxconio@libero.it
A. De Ceglie , M.D. Department of Gastroenterology and Digestive Endoscopy , Cancer Institute Giovanni Paolo II , Bari , Italy
9– 11 ] .
While the role of stents in palliation of malignant strictures has been well established, their use in benign strictures has gained increasing acceptance in the last few years. Severe dysphagia can occur with benign esophageal strictures following radiotherapy, caustic ingestion, peptic injury, and surgery. Placement of a stent in benign strictures is challenging and sometimes risky [ 12, 13 ] . Endoscopic dilatation with bougies or through­the-scope (TTS) balloons is the standard treatment for such lesions, but in 10% of patients who develop refractory and recurrent strictures, the temporary placement of a stent should be consid­ered [ 14– 23 ] . In addition, stents have also been proven effective in management of esophagorespi­ratory fi stula (ERF), anastomotic leaks, and rup­tures. Their use has also been promulgated for patients with bleeding esophageal varices [ 24– 26 ] . This chapter describes the esophageal stents cur­rently used for malignant and benign conditions.
Available Esophageal Stents
In the United States, the Food and Drug Administration (FDA) has approved esophageal metal stents for palliation of malignant dysphagia: Ultra fl ex stent (Boston Scienti fi c, Natick, MA, USA); Niti-S stent (Taewoong Medical, Seoul, Korea); Evolution stent (Cook Medical, Winston Salem, NC, USA); Alimaxx-ES (Merit Medical System); Esophageal Z-stent (Cook Medical, Winston Salem, NC, USA); Dua antire fl ux (Cook Medical, Winston Salem, NC, USA); Wall fl ex ®
R. Kozarek et al. (eds.), Self-Expandable Stents in the Gastrointestinal Tract, DOI 10.1007/978-1-4614-3746-8_5, © Springer Science+Business Media New York 2013
73
74
M. Conio and A. De Ceglie
(Boston Scienti fi c, Natick, MA, USA), and Bonastent
®
(Standard Sci Tech, Seoul, Korea). Additional stents are currently available in Europe, including Hanaro stent and Choo stent (MI Tech, Seoul, South Korea), the ENDO-FLEX (GmbH, Voerde, Germany), and the FerX-ELLA and SX-ELLA stent (ELLA-CS, Hradec Kralove, Czech Republic). A biodegradable version of ELLA is also available. Table 5.1 displays the variety of SEMS that are marketed. Figure 5.1 shows the most commonly used SEMS types.
Both in Europe and the United States, a remov­able, fully covered, self-expanding plastic stent (SEPS), the Poly fl ex (Boston Scienti fi c, Natick, MA, USA), has been introduced as an alternative to SEMS. Because of its removability, the FDA has approved it for benign disease.
We have summarized the technical character­istics of the most commonly available self­expanding metal and plastic stents:
Ultra fl ex stent (Boston Scienti fi c, Natick, MA, •
USA) is a partially covered SEMS with a mesh
knitted from a single elastic wire of nitinol. It
is mounted with a long thread that holds the
compressed stent. The end of the thread is
pulled through the catheter lumen to the oppo-
site end of the catheter and tied to a plastic
ring. The stent is released by pulling the
thread. There are four radiopaque markers.
The inner 2 markers indicate the fi nal position
of the covered part of the deployed stent and
the outer 2 the position of the uncovered
portion.
Wall fl ex •
®
(Boston Scienti fi c, Natick, MA, USA) is a partially or fully covered stent con­structed of multiple braided wires with an internal silicone covering and uncoated fl anges on both ends. The fully covered esophageal Wall fl ex presents the silicone covering extend­ing over the full length of the stent. The pres­ence of progressive step fl ared ends creates a wedge at either end to reduce the migration. Niti-S stent (Taewoong Medical, Seoul, Korea) • is composed of a single thread of 0.2-mm nitinol wire and an inner polyurethane layer. The stent is delivered in a compressed form inside an introducer sheath of 4 mm in diam­eter. The company also produces esophageal
SEMS with a delivery system of 10 F that can be introduced through the operative channel of a therapeutic endoscope. To prevent migra­tion, the stent has a dog-bone shape: the diam- eter of the body can be 16, 18, and 20 mm, while that of both ends can be 24, 26, and 28 mm . Another characteristic is the conform- ability, as the stent adapts to the morphology of the stricture after its release. For cancer involving the distal esophagus and • the esophagogastric junction, there is a Niti-S double stent, with a double-layer con fi guration over the body, consisting of an inner polyure­thane layer (covering the whole stent) and an outer uncovered nitinol wire. The ingrowth of the malignant tissue through the mesh of this outer wire is thought to prevent migration of the stent into the stomach. The Conio stent is a modi fi ed Niti-S prosthesis for hypopharyn­geal strictures; it is characterized by small diameters (12, 14, and 16 mm in the body; 14, 16, and 18 mm for the fl ared upper end), and the available lengths are 8, 10, and 12 cm. Evolution •
®
stent (Cook Endoscopy, Limerick, Ireland) is made of a single nitinol wire, and it is preloaded on a gun-like delivery system. The stent can be recaptured before it has been completely deployed. In November 2010, the Evolution ® Controlled Release Esophageal Fully Covered Stent was approved by the FDA. This stent is characterized by an inner and outer silicone layer that resists tumor ingrowth. Another type of fully covered Esophageal Z-Stent with a DUA antire fl ux valve (Cook Endoscopy, Winston Salem, NC, USA) is also available. Alimaxx-E (Alveolus, Charlotte, NC, USA) is • a laser-cut stent from a nitinol tube and fully covered with polyurethane. Small metal struts project from the outer part of the stent to avoid migration. It can be placed over a guide wire in the esophagus. In March 2009, Merit Medical Systems, Inc. (South Jordan, Utah, USA) acquired the products formerly manu­factured and distributed by Alveolus, and the Alimaxx-ES™ is the stent now produced. SX-ELLA stent (ELLA-CS, Hradec Kralove, • Czech Republic) is a SEMS composed of