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Initial multicenter experience using a novel endoscopic tack and suture system for challenging GI defect closure and stent fixation (with video)

Open AccessPublished:October 22, 2021DOI:https://doi.org/10.1016/j.gie.2021.10.018

      Background and Aims

      Closure of endoscopic resection defects can be achieved with through-the-scope clips, over-the-scope clips, or endoscopic suturing. However, these devices are often limited by their inability to close large, irregular, and difficult-to-reach defects. Thus, we aimed to assess the feasibility and safety of a novel through-the-scope, suture-based closure system developed to overcome these limitations.

      Methods

      This was a retrospective multicenter study involving 8 centers in the United States. Primary outcomes were feasibility and safety of early use of the device. Secondary outcomes were assessment of need for additional closure devices, prolonged procedure time, and technical feasibility of performing the procedure with an alternative device(s).

      Results

      Ninety-three patients (48.4% women) with mean age 63.6 ± 13.1 years were included. Technical success was achieved in 83 patients (89.2%), and supplemental closure was required in 24.7% of patients (n = 23) with a mean defect size of 41.6 ± 19.4 mm. Closure with an alternative device was determined to be impossible in 24.7% of patients because of location, size, or shape of the defect. The use of the tack and suture device prolonged the procedure in 8.6% of cases but was considered acceptable. Adverse events occurred in 2 patients (2.2%) over a duration of follow-up of 34 days (interquartile range, 13-93.5) and were mild and moderate in severity. No serious adverse events or procedure-related deaths occurred.

      Conclusions

      The novel endoscopic through-the-scope tack and suture system is safe, efficient, and permits closure of large and irregularly shaped defects that were not possible with established devices.

      Graphical abstract

      Abbreviations:

      AE (adverse event), ESD (endoscopic submucosal dissection), IQR (interquartile range), OTS (over-the-scope), TTS (through-the-scope)
      Endoscopic resection of GI lesions is one of the more commonly performed procedures in endoscopy and can be accomplished with snare polypectomy, EMR, or endoscopic submucosal dissection (ESD) techniques. All resection methods may result in large defects, which can lead to perforation or bleeding. Several studies have shown a decrease in postprocedural perforation and bleeding with selective prophylactic closure of resection defects.
      • Nishiyama N.
      • Mori H.
      • Kobara H.
      • et al.
      Efficacy and safety of over-the-scope clip: including complications after endoscopic submucosal dissection.
      • Zhang Q.S.
      • Han B.
      • Xu J.H.
      • et al.
      Clip closure of defect after endoscopic resection in patients with larger colorectal tumors decreased the adverse events.
      • Kantsevoy S.V.
      • Bitner M.
      • Mitrakov A.A.
      • et al.
      Endoscopic suturing closure of large mucosal defects after endoscopic submucosal dissection is technically feasible, fast, and eliminates the need for hospitalization (with videos).
      • Chen B.
      • Du L.
      • Luo L.
      • et al.
      Prophylactic clips to reduce delayed polypectomy bleeding after resection of large colorectal polyps: a systematic review and meta-analysis of randomized trials.
      This can be achieved with through-the-scope (TTS) clips, over-the-scope (OTS) clips, or endoscopic suturing.
      TTS clips were initially developed for hemostasis, but their application has broadened to include closure of GI defects.
      • Hayashi T.
      The study on stanch clips for the treatment by endoscopy.
      However, their use is limited by the restricted grasp of tissue with apposition of the mucosal layers only, low closure force, need for multiple clips, and expense when multiple clips are used.
      • Mangiavillano B.
      • Viaggi P.
      • Masci E.
      Endoscopic closure of acute iatrogenic perforations during diagnostic and therapeutic endoscopy in the gastrointestinal tract using metallic clips: a literature review.
      OTS clips are biocompatible nitinol clips with a bear-trap design that allows for full-thickness closure of GI defects.
      • Cereatti F.
      • Grassia R.
      • Drago A.
      • et al.
      Endoscopic management of gastrointestinal leaks and fistulae: What option do we have?.
      However, OTS clips may not be ideal for defects larger than 20 mm or that have inflammatory or necrotic margins.
      • Hagel A.F.
      • Naegel A.
      • Lindner A.S.
      • et al.
      Over-the-scope clip application yields a high rate of closure in gastrointestinal perforations and may reduce emergency surgery.
      Furthermore, OTS clips require endoscope withdrawal from the patient for device loading.
      • Kirschniak A.
      • Subotova N.
      • Zieker D.
      • et al.
      The over-the-scope clip (OTSC) for the treatment of gastrointestinal bleeding, perforations, and fistulas.
      The OverStitch (Apollo Endosurgery, Inc, Austin, Tex, USA) device is an endoscopic suturing system developed for soft-tissue approximation in the GI tract.
      • Kantsevoy S.V.
      • Bitner M.
      • Mitrakov A.A.
      • et al.
      Endoscopic suturing closure of large mucosal defects after endoscopic submucosal dissection is technically feasible, fast, and eliminates the need for hospitalization (with videos).
      However, it necessitates the use of a double-channel upper endoscope that generally precludes its use in the right-sided colon and also requires endoscope withdrawal for mounting the device and reinsertion to the target site.
      • Yu J.X.
      • Schulman A.R.
      Complications of the use of the OverStitch endoscopic suturing system.
      Thus, a novel endoscopic tack and suture device was developed to overcome these limitations.
      • Hernandez A.
      • Marya N.B.
      • Sawas T.
      • et al.
      Gastrointestinal defect closure using a novel through-the-scope helix tack and suture device compared to endoscopic clips in a survival porcine model (with video).
      The X-Tack Endoscopic HeliX Tacking System (Apollo Endosurgery, Inc) is a TTS, suture-based device that was designed for closure of large, wide, and irregularly shaped defects in the upper and lower GI tract. The device was recently approved by the U.S. Food and Drug Administration for soft-tissue approximation in minimally invasive endoscopic procedures. This encompasses closure of ESD or EMR defects, fistulas, perforations, and leaks. In a preclinical study that contributed to approval of the device for clinical use, no adverse events (AEs) were reported.
      • Hernandez A.
      • Marya N.B.
      • Sawas T.
      • et al.
      Gastrointestinal defect closure using a novel through-the-scope helix tack and suture device compared to endoscopic clips in a survival porcine model (with video).
      However, possible AEs include wound dehiscence, delayed perforation, and bleeding if the tacking system is improperly placed. The primary aim of this study was to determine the feasibility and safety of the novel TTS tack and suture system.

      Methods

      This was a retrospective multicenter study involving 8 academic and community centers in the United States. Institutional Review Board approval was obtained from Mayo Clinic Rochester (number 21-002164), which served as the primary site for data consolidation and authorship. Additional Institutional Review Board approval was obtained independently for all centers involved.
      The electronic medical records of consecutive patients who underwent application of the tack and suture device from January 2021 to June 2021 were reviewed. The case contributions from the centers were as follows: Mayo Clinic Rochester, 38; NYU Langone Hospital, 16; Riverside Health System, 13; Mayo Clinic Scottsdale, 12; UMASS Memorial Medical Center, 5; Johns Hopkins Medical Institutions, 5; Brigham and Women’s Hospital, 3; and Mayo Clinic Health System in Eau Claire, Wisconsin, 2.
      Endoscopic procedures were performed across all participating centers by 15 endoscopists who were recently introduced to the device and received virtual or hands-on ex vivo training for up to 1 hour before their first clinical use. Endoscopists were asked within 1 week or less of each case to document the alternative devices that may have been used to perform defect closure in each case, the specific number of TTS clips they anticipate would have been required to perform the same closure, the duration of procedure prolongation, and the technical feasibility of performing the procedure with an alternative device. In addition, all lesions were photo-documented and reviewed by a second physician for size confirmation. Data were abstracted for patient and procedural characteristics, treatment outcomes, AEs, and duration of follow-up.
      The primary outcomes of the study were feasibility, defined by technical success, and safety, defined by the AE rate. Technical success was defined as successful placement of the device helices resulting in either complete closure of a defect or stent fixation as intended. AEs were graded per the American Society for Gastrointestinal Endoscopy lexicon classification.
      • Cotton P.B.
      • Eisen G.M.
      • Aabakken L.
      • et al.
      A lexicon for endoscopic adverse events: report of an ASGE workshop.
      Mild AEs included symptoms requiring postprocedural medical consultation and moderate AEs included symptoms requiring a repeat endoscopy.
      • Cotton P.B.
      • Eisen G.M.
      • Aabakken L.
      • et al.
      A lexicon for endoscopic adverse events: report of an ASGE workshop.
      Secondary outcomes were assessment of need for additional closure devices, prolonged procedure time, and endoscopists’ opinions regarding the technical feasibility of performing the procedure with an alternative device(s).

      Device specifications

      The X-Tack device is composed of four 5-mm, surgical steel helix tacks tethered on a single 3-0 polypropylene suture that runs through an eyelet near the mid-point on each tack. Each helix tack is deployed sequentially through a ≥2.8-mm working channel of any commercially available gastroscope or colonoscope, without the need for instrument withdrawal from the patient. The tacks are screwed into healthy target tissue adjacent to the defect or stent, followed by approximation of the margins by successive gathering of the tacks with applied suture tension, and placement of a final cinch to secure the construct.
      • Hernandez A.
      • Marya N.B.
      • Sawas T.
      • et al.
      Gastrointestinal defect closure using a novel through-the-scope helix tack and suture device compared to endoscopic clips in a survival porcine model (with video).
      ,
      • Hernandez-Lara A.
      • de Paredes A.G.G.
      • Rajan E.
      • et al.
      Step-by-step instruction: using an endoscopic tack and suture device for gastrointestinal defect closure.
      Hernandez-Lara et al
      • Hernandez-Lara A.
      • de Paredes A.G.G.
      • Rajan E.
      • et al.
      Step-by-step instruction: using an endoscopic tack and suture device for gastrointestinal defect closure.
      described a step-by-step technique for using the tack and suture device for closure of GI defects.

      Statistical analysis

      Data are expressed as means and standard deviations or medians and interquartile ranges (IQRs) for continuous variables and as proportions for categorical variables. Statistical analysis was performed using IBM SPSS 27.0 (SPSS, Chicago, Ill, USA).

      Results

      Baseline characteristics

      Ninety-three patients (48.4% women) with a mean age of 63.6 ± 13.1 years underwent application of the tack and suture device for closure of a defect or stent fixation as intended. The most common site of application was the colon (n = 48, 51.6%), followed by the small bowel (n = 22, 23.7%), stomach (n = 15, 16.1%), and esophagus (n = 8, 8.6%). The main indications for application of the device were closure of ESD (n = 35, 37.6%) and EMR (n = 19, 20.4%) defects, stent fixation (n = 13, 14.0%), and fistula closure (n = 11, 11.8%). Additional indications were ulcer repair (n = 4, 4.3%), perforation repair (n = 3, 3.2%), postpolypectomy repair (n = 2, 2.1%), mucosotomy closure after peroral endoscopic myotomy (n = 2, 2.1%), endoscopic full-thickness resection defect closure (n = 1, 1.1%), anastomotic dehiscence repair (n = 1, 1.1%), mucosal tear (n = 1, 1.1%), and reinforcement of granulation tissue (n = 1, 1.1%). The mean defect size was 37.1 ± 20.2 mm, with full-thickness defects present in 18.7% of patients (n = 17).
      Baseline characteristics of the patients are described in Table 1. Figure 1 shows endoscopic applications of the device for various defect closures and stent fixation. Video 1 (available online at www.giejournal.org) demonstrates the application of the tack and suture device for mucosal defect closure and stent fixation.
      Table 1Baseline characteristics (n = 93)
      CharacteristicValue
      Age, y63.6 ± 13.1
      Female sex45 (48.4)
      Site
       Esophagus8 (8.6)
       Stomach15 (16.1)
       Small bowel22 (23.7)
       Colon48 (51.6)
      Indication
       Endoscopic submucosal dissection35 (37.6)
       EMR19 (20.4)
       Stent fixation13 (14.0)
       Fistula11 (11.8)
       Ulcer4 (4.3)
       Perforation3 (3.2)
       Postpolypectomy closure2 (2.2)
       Peroral endoscopic myotomy mucosotomy2 (2.2)
       Endoscopic full-thickness resection1 (1.1)
       Anastomotic dehiscence1 (1.1)
       Mucosal tear1 (1.1)
       Reinforcement of granulation tissue1 (1.1)
      Full-thickness defect17 (18.7)
      Size of defect, mm (n = 74)37.1 ± 20.2
      Values are mean ± standard deviation or n (%).
      Figure thumbnail gr1af
      Figure 1Applications of the tack and suture device. A, Colonic EMR defect. B, Closure of the colonic EMR defect with tack and suture device. C, Closed EMR defect after deployment of cinch. D, Jejunal fistula. E, Closure of fistula with tack and suture device. F, Closed fistula after deployment of cinch. G, A perforated gastric ulcer. H, Closure of a perforated ulcer with tack and suture device. I, Closed perforated ulcer after deployment of cinch. J, A lumen-apposing metal stent anchored by the tack and suture device for a duodenal stricture. K, Removal of the stent. L, Patent duodenal lumen after removal of the stent.
      Figure thumbnail gr1gl
      Figure 1Applications of the tack and suture device. A, Colonic EMR defect. B, Closure of the colonic EMR defect with tack and suture device. C, Closed EMR defect after deployment of cinch. D, Jejunal fistula. E, Closure of fistula with tack and suture device. F, Closed fistula after deployment of cinch. G, A perforated gastric ulcer. H, Closure of a perforated ulcer with tack and suture device. I, Closed perforated ulcer after deployment of cinch. J, A lumen-apposing metal stent anchored by the tack and suture device for a duodenal stricture. K, Removal of the stent. L, Patent duodenal lumen after removal of the stent.

      Technical success

      Technical success of the intended use of the device was achieved in 83 patients (89.2%). Closure was partially successful in 8 patients (8.6%), with full closure requiring the use of additional TTS clips in 3 of these cases. Closure was unsuccessful in 2.2% of patients, including a colonic EMR defect (45 mm) because of suture rupture with applied tension during cinching and a mid-jejunal perforation because of poor tissue approximation. Most treatment sites (68.8%) required the use of 1 device, 18.3% of sites required 2 devices, 11.8% of sites required 3 devices, and 1.1% required 4 devices. Treatment outcomes are described in Table 2.
      Table 2Treatment outcomes (n = 93)
      OutcomesValue
      Technical success
       Yes83 (89.2)
       No10 (10.8)
      Successful closure or fixation
       Complete83 (89.2)
       Partial8 (8.6)
       Failed2 (2.2)
      Technical success (stratified by size)
       <20 mm9 (90.0)
       20-30 mm12 (92.3)
       >30 mm44 (86.3)
      No. of tack and suture devices used
       1 device64 (68.8)
       2 devices17 (18.3)
       3 devices11 (11.8)
       4 devices1 (1.1)
      Additional closure needed after tack and suture
       Yes23 (24.7)
       No70 (75.3)
      Supplemental closure
       TTS clip21 (22.6)
       OTS clip1 (1.1)
       Vascular plug (Amplatzer vascular plug-II)1 (1.1)
      Median no. of additional TTS clips used4 (2-6)
      Tack and suture device used to salvage another failed closure
       Yes7 (7.5)
       No86 (92.5)
      Use of the tack and suture device prolonged the procedure
       Yes8 (8.6)
       No85 (91.4)
      Duration by which the use of the tack and suture device prolonged the procedure, min12.8 ± 3.9
      Closure technically feasible with another device
       Yes70 (75.3)
       No23 (24.7)
      Type of device with which closure was technically feasible
       TTS clip54 (58.1)
       OTS clip19 (20.4)
       OverStitch device27 (29.0)
      Median no. of TTS clips needed8 (6-12)
      Adverse events2 (2.2)
      Median duration of follow-up, days34 (13.0-93.5)
      Values are mean ± standard deviation, n (%), or median (interquartile range).
      TTS, Through-the-scope; OTS, over-the-scope.
      Supplemental closure with a device other than the tack and suture system was required in 24.7% of patients (n = 23). Closure with TTS clips was required in 22.6% of patients (n = 21) with a median number of 4 TTS clips (IQR, 2-6) used to supplement the initial closure. Additional closure with an OTS clip (n = 1) and an Amplatzer vascular plug-II (Abbott, Chicago, Ill, USA) (n = 1) was performed. The use of the tack and suture system was considered by the performing endoscopist to have prolonged the procedure in 8.6% of patients (n = 8) by a mean duration of 12.8 ± 3.9 minutes per system but was considered “acceptable” by the performing endoscopist in all cases. Closure accomplished by the tack and suture system was believed to be technically feasible with another device in 75.3% of patients (n = 70), including TTS clips in 58.1% (n = 54), OTS clips in 20.4% (n = 19), and the OverStitch device in 29.0% (n = 27).

      Adverse events

      AEs occurred in 2 patients (2.2%) over a follow-up of 34 days (IQR, 13-93.5). One patient who underwent closure of a colonic EMR defect developed right lower quadrant pain 1 day postprocedurally and was managed conservatively. Another patient who underwent closure of a small-bowel ESD defect developed hematemesis 9 days postprocedurally, and a repeat endoscopy showed bleeding at the site of the mucosal closure. The patient required intensive care unit monitoring for 1 night, 4 units of packed red blood cells, and endoscopic thermal coagulation and clip placement of the site of bleeding. The patient was successfully discharged home in stable condition. These AEs were classified as mild and moderate, respectively.

      Endoscopist estimates of alternative TTS clip usage

      Endoscopists were asked after each case to provide an estimate of the number of TTS clips they anticipated would have been required to perform the same closure. For defects <20 mm, the median number of estimated TTS clips required was 4. For defects of 20 to 30 mm, the median estimated number of TTS clips required was 6. For defects >30 mm, the median number of TTS clips required was 10.

      Discussion

      This is the first multicenter study describing the feasibility and safety of the novel endoscopic tack and suture device in the clinical setting. Because of ease of use and a rapid learning curve, participating endoscopists from academic and community centers readily implemented the device during initial applications. Technical success with the tack and suture device was achieved in 89.2% of cases. The stratification of technical success according to size of the defect showed success rates of 90.0%, 92.3%, and 86.3% for defects <20 mm, 20 to 30 mm, and >30 mm, respectively. These rates are comparable with the reported success rates of 57.0% to 100% for TTS clips,
      • Zhang Q.S.
      • Han B.
      • Xu J.H.
      • et al.
      Clip closure of defect after endoscopic resection in patients with larger colorectal tumors decreased the adverse events.
      ,
      • Hernandez A.
      • Marya N.B.
      • Sawas T.
      • et al.
      Gastrointestinal defect closure using a novel through-the-scope helix tack and suture device compared to endoscopic clips in a survival porcine model (with video).
      ,
      • Lee S.
      • Ahn J.Y.
      • Jung H.Y.
      • et al.
      Clinical outcomes of endoscopic and surgical management for postoperative upper gastrointestinal leakage.
      • Kantsevoy S.V.
      • Bitner M.
      • Hajiyeva G.
      • et al.
      Endoscopic management of colonic perforations: clips versus suturing closure (with videos).
      • Albéniz E.
      • Álvarez M.A.
      • Espinós J.C.
      • et al.
      Clip closure after resection of large colorectal lesions with substantial risk of bleeding.
      79.0% to 100% for OTS clips,
      • Nishiyama N.
      • Mori H.
      • Kobara H.
      • et al.
      Efficacy and safety of over-the-scope clip: including complications after endoscopic submucosal dissection.
      ,
      • Mennigen R.
      • Colombo-Benkmann M.
      • Senninger N.
      • et al.
      Endoscopic closure of postoperative gastrointestinal leakages and fistulas with the over-the-scope clip (OTSC).
      • Sandmann M.
      • Heike M.
      • Faehndrich M.
      Application of the OTSC system for the closure of fistulas, anastomosal leakages and perforations within the gastrointestinal tract.
      • Meier B.
      • Caca K.
      • Schmidt A.
      Hybrid endoscopic mucosal resection and full-thickness resection: a new approach for resection of large non-lifting colorectal adenomas (with video).
      • Wedi E.
      • Gonzalez S.
      • Menke D.
      • et al.
      One hundred and one over-the-scope-clip applications for severe gastrointestinal bleeding, leaks and fistulas.
      and 88.2% to 100% for endoscopic suturing.
      • Kantsevoy S.V.
      • Bitner M.
      • Mitrakov A.A.
      • et al.
      Endoscopic suturing closure of large mucosal defects after endoscopic submucosal dissection is technically feasible, fast, and eliminates the need for hospitalization (with videos).
      ,
      • Kantsevoy S.V.
      • Bitner M.
      • Hajiyeva G.
      • et al.
      Endoscopic management of colonic perforations: clips versus suturing closure (with videos).
      ,
      • Kobayashi M.
      • Sumiyama K.
      • Ban Y.
      • et al.
      Closure of iatrogenic large mucosal and full-thickness defects of the stomach with endoscopic interrupted sutures in in vivo porcine models: are they durable enough?.
      In this study, 8 patients (8.6%) with EMR/ESD defects (n = 5), fistulas (n = 2), and anastomotic dehiscence (n = 1) attained only partial closure, with a mean defect size of 42.3 ± 22.5 mm. In 5 of 8 of those defects, additional closure with TTS clips was performed in 4 cases of EMR/ESD defects and in 1 case of anastomotic dehiscence. However, it is important to note that even though only partial closure was attained in the case of anastomotic dehiscence, multiple attempts at closure with clips and endoscopic suturing had previously failed. In addition, the patient did well and had no reported AEs during follow-up. In 3 of the 8 of failed closures, no additional closure was attempted in 1 case of an 80-mm ESD defect and 2 fistula cases because the use of an alternative device(s) was unlikely to succeed. Furthermore, prior closure attempts for the 2 fistula cases using TTS clips, OTS clips, or endoscopic suturing were unsuccessful, highlighting the fact that the tack and suture device was determined to be the only remaining closure option in such cases. Therefore, it appears that even partial closure of defects using the tack and suture device may provide a satisfactory outcome in select cases, with no AEs reported during follow-up.
      Failed closure was seen in only 2 patients (2.2%). One patient had failed closure because of suture rupture during cinching, and the defect was subsequently successfully closed with multiple TTS clips. Another patient had failed closure of a mid-jejunal perforation because of poor tissue approximation during cinching and was subsequently managed with a vascular plug under fluoroscopic guidance. Despite these few unsuccessful attempts at complete defect closure, our results demonstrate high technical success and favorable treatment outcomes in most cases.
      Supplemental closure was required in 24.7% of patients with a mean defect size of 41.6 ± 19.4 mm. Closure with TTS clips was required in 22.6% of patients, and the median number of TTS clips used was 4 (IQR, 2-6). However, the use of additional TTS clips after closure with the tack and suture device was performed at only 1 participating center in the study, which may be because of operator preference for double-layer closure as confidence is accumulated with the use of the device. Additional closure with an OTS clip (n = 1) and a vascular plug (n = 1) was also performed in 2 complex cases. The use of the device was considered to have prolonged the procedure in 8.6% of patients (8/93) by a mean duration of 12.8 ± 3.9 minutes per tack and suture system. In 4 of 8 of those prolonged procedures, the defect was deemed unamenable for closure using another device because of large size, irregular shape, and/or location of the defect. In the remaining 4 patients, closure of the defect was deemed technically feasible with endoscopic suturing and/or TTS clips (range, 10-25 TTS clips).
      Given the expanding repertoire of closure devices available to the endoscopist, it is important to consider cost-effectiveness of various endoscopic closure devices. The cost of 1 TTS clip ranges from U.S.$150 to more than $250, which would total more than $1500 to $6000 per closure of these defects. The cost of the OTS clip ranges from $438 to more than $600, with an additional cost for grasping and anchoring tools. The OverStitch endoscopic suturing system has been reported to cost approximately $1000, with an additional cost of $125 per unit for each suture and cinch.
      • Wellington J.
      • Canakis A.
      • Kim R.
      Endoscopic closure devices: a review of technique and application for hemostasis.
      In contrast, 1 X-Tack suturing system along with a cinch costs up to $695. Determining best practice and cost-efficiency of these various closure devices is desirable. Table 3 summarizes the advantages, disadvantages, and cost comparison across all devices. The median number of tack and suture devices used was compared with the estimated number of TTS clips needed to close a defect of the same size. For defects <20 mm, 20 to 30 mm, and >30 mm, the median number of TTS clips needed was estimated to be 4, 6, and 10, respectively. In contrast, only 1 tack and suture device was required to close the defects of all sizes. This shows that at all defect sizes, the estimated number of TTS clips needed is higher compared with the number of tacks used, which further recapitulates the importance of cost-efficiency consideration.
      Table 3Advantages, disadvantages, and cost comparison of X-Tack, TTS clips, OTS clips, and OverStitch device
      DeviceAdvantagesDisadvantagesCost (U.S.$)
      X-TackEfficacious for defects >30 mm

      Closure of irregularly shaped defects

      Closure of defects in the proximal colon

      No need for endoscope withdrawal

      Ease of use
      Robustness of closure force undetermined695 per device and cinch
      TTS clipsWell studied

      Ease of use
      Restricted grasp of tissue

      Low closure force

      Need for multiple clips

      Expensive if multiple clips are needed
      150-250 per clip
      OTS clipsLarger clip size compared with TTS clips

      Robust closure
      Efficacious for defects <20 mm

      Need for endoscope withdrawal and device loading

      Device passage through narrowed, angulated lumen
      438-600 per clip
      OverStitchNo defect size limitation

      Full-thickness closure
      Need for endoscope withdrawal and device loading

      Restricted access because of need for specialized double-channel upper endoscope

      Learning curve

      Expensive
      1000 per 1 suture system

      125 per additional suture and cinch
      TTS, Through-the-scope; OTS, over-the-scope.
      Closure with a device other than the investigated suture system was determined by the performing endoscopist to be infeasible in 24.7% of cases because of location, size, or shape of the defect, highlighting the importance of this new TTS suturing device in the armamentarium of endoscopic tools for defect closure. Moreover, successful salvage closure with the tack and suture device was performed in 7 patients (7.5%) after multiple failed attempts using TTS clips (n = 3), OTS clips (attempted twice, n = 1), and endoscopic suturing (n = 3). We anticipate that not needing to withdraw the endoscope from the patient for loading OTS clips or the endoscopic suturing system will be particularly beneficial for challenging right-sided colonic defects and perforations.
      • Hernandez A.
      • Marya N.B.
      • Sawas T.
      • et al.
      Gastrointestinal defect closure using a novel through-the-scope helix tack and suture device compared to endoscopic clips in a survival porcine model (with video).
      Even though the tack and suture system was applied primarily for closure of ESD (n = 35, 37.6%) and EMR (n = 19, 20.4%) defects, stent fixation (n = 13, 14.0%), and fistula closure (n = 11, 11.8%), it is important to highlight the additional applications of the device, such as repair of small-bowel defects after snare polypectomy, closure of an anastomotic dehiscence after multiple failed attempts at closure with other devices, repair of a mucosal tear caused by the tip of a balloon dilator as it was passed through a strictured gastroesophageal junction, and reinforcement of healthy granulation tissue in a resolved fistula in the distal rectum. This experience illustrates the versatility of the device, with its applications ranging from closure of a wide variety of defects to the off-label use of stent fixation.
      Although the study was not designed to provide long-term follow-up because of the lack of clinical need for surveillance endoscopy within 3 to 6 months for most resected lesions, follow-up endoscopy was available in 12 of 93 patients. Of these 12 patients, 1 patient with a 30-mm gastric EMR defect showed retained tacks and suture on a 3-month follow-up endoscopy. The tacks and suture were removed; however, the area demonstrated an abnormal mucosal pattern suggestive of residual dysplasia that required a wide piecemeal mucosal resection. In 1 patient with a gastric fistula, a follow-up endoscopy 4 months later showed a resolved fistula with the cinch still in place. In another patient with a 25-mm marginal ulcer in the jejunum, a follow-up endoscopy performed 2 months after showed a persistent 15-mm marginal ulcer with the previously placed tack and suture device partially retained in the tissue. The tack and suture device was removed, and the marginal ulcer was repaired using the OverStitch device. In 1 patient with a colon fistula, a follow-up colonoscopy 2 months later showed a resolving fistula. One patient with a 35-mm colonic EMR defect that was successfully closed with the tack and suture device developed hematochezia 2 weeks postprocedurally. A repeat colonoscopy showed a well-healed and closed defect with no evidence for stigmata of recent bleeding. The tack and suture construct was still present at the site, with 2 of 4 tacks remaining in the tissue. The source of bleeding was determined to be a separate and smaller EMR defect, which had been closed prophylactically with TTS clips. The patient remained hemodynamically stable and was subsequently discharged. In another patient with a 25-mm, poorly healing, postpolypectomy ulcer bleeding in the colon, successful closure of the defect with the tack and suture device was performed after failed closure with TTS clips. A follow-up colonoscopy at 3 months showed a well-healed defect with 1 of 4 tacks still in place. In 6 cases of stent fixation, 5 patients successfully completed their intended stent dwell time that averaged 2 months, and the tack and suture fixation was still intact at the time of stent removal. The suture was easily removed using endoscopic scissors. However, 1 patient with gastric bypass anatomy who underwent stent placement across a strictured gastrojejunal anastomosis experienced stent migration despite tack and suture fixation, requiring retrieval of the stent using single-balloon enteroscopy at the 1-month follow-up.
      Application of the tack and suture device is a relatively safe procedure. AEs occurred in 2.2% of patients in this study and were mild to moderate in severity. One patient with a 30-mm EMR defect in the colon developed postprocedural abdominal pain that was managed conservatively and conceivably may have been caused by factors other than the tack and suture closure. One patient with a 100-mm gastric ESD defect closed using the tack and suture device developed bleeding and required transfusion and endoscopic reintervention. No serious AEs or procedure-related deaths occurred. Previously published studies have reported AE rates of 0% to 5.1% for TTS clips,
      • Zhang Q.S.
      • Han B.
      • Xu J.H.
      • et al.
      Clip closure of defect after endoscopic resection in patients with larger colorectal tumors decreased the adverse events.
      ,
      • Lee S.
      • Ahn J.Y.
      • Jung H.Y.
      • et al.
      Clinical outcomes of endoscopic and surgical management for postoperative upper gastrointestinal leakage.
      0% to 38.4% for OTS clips,
      • Nishiyama N.
      • Mori H.
      • Kobara H.
      • et al.
      Efficacy and safety of over-the-scope clip: including complications after endoscopic submucosal dissection.
      ,
      • Mennigen R.
      • Colombo-Benkmann M.
      • Senninger N.
      • et al.
      Endoscopic closure of postoperative gastrointestinal leakages and fistulas with the over-the-scope clip (OTSC).
      • Sandmann M.
      • Heike M.
      • Faehndrich M.
      Application of the OTSC system for the closure of fistulas, anastomosal leakages and perforations within the gastrointestinal tract.
      • Meier B.
      • Caca K.
      • Schmidt A.
      Hybrid endoscopic mucosal resection and full-thickness resection: a new approach for resection of large non-lifting colorectal adenomas (with video).
      • Wedi E.
      • Gonzalez S.
      • Menke D.
      • et al.
      One hundred and one over-the-scope-clip applications for severe gastrointestinal bleeding, leaks and fistulas.
      ,
      • Tashima T.
      • Ohata K.
      • Sakai E.
      • et al.
      Efficacy of an over-the-scope clip for preventing adverse events after duodenal endoscopic submucosal dissection: a prospective interventional study.
      and 0% to 43% for endoscopic suturing,
      • Kantsevoy S.V.
      • Bitner M.
      • Mitrakov A.A.
      • et al.
      Endoscopic suturing closure of large mucosal defects after endoscopic submucosal dissection is technically feasible, fast, and eliminates the need for hospitalization (with videos).
      ,
      • Kantsevoy S.V.
      • Bitner M.
      • Hajiyeva G.
      • et al.
      Endoscopic management of colonic perforations: clips versus suturing closure (with videos).
      ,
      • Chung J.
      • Wang K.
      • Podboy A.
      • et al.
      Endoscopic suturing for the prevention and treatment of complications associated with endoscopic mucosal resection of large duodenal adenomas.
      • Granata A.
      • Amata M.
      • Ligresti D.
      • et al.
      Endoscopic management of post-surgical GI wall defects with the overstitch endosuturing system: a single-center experience.
      • Sharaiha R.Z.
      • Kumta N.A.
      • DeFilippis E.M.
      • et al.
      A large multicenter experience with endoscopic suturing for management of gastrointestinal defects and stent anchorage in 122 patients: a retrospective review.
      with abdominal pain and bleeding the most commonly described AEs. The rate of AEs for the tack and suture system compares favorably with these devices.
      Limitations of this study include its retrospective design and relatively short duration of follow-up. In addition, although revision of photo-documented lesions by a second physician for size confirmation improves the validity of our data, interobserver variability serves as a limitation even among experts with extensive experience.
      • Hyun Y.S.
      • Han D.S.
      • Bae J.H.
      • et al.
      Interobserver variability and accuracy of high-definition endoscopic diagnosis for gastric intestinal metaplasia among experienced and inexperienced endoscopists.
      Furthermore, even though data collection was efficient and performed within 1 week or less from the procedures, it may be subject to recall bias. Because of the retrospective nature of the study, data on the reasons for requiring supplemental closure were not available, which also serves as a limitation and is an important consideration for future prospective or registry studies. Despite the limitations of this study, it is the first such study to demonstrate the feasibility and safety of the novel endoscopic tack and suture device for a wide variety of applications in both tertiary care academic and community practice settings.
      As endoscopic tissue resection and intervention grows to include increasingly complex and large defects, sometimes in difficult-to-reach areas of the GI tract, the novel tack and suture device appears to be a safe, versatile, and potentially cost-effective TTS device for closure of various defects and for stent fixation. Moreover, the use of the tack and suture device by a diverse group of endoscopists from both academic and community centers illustrates its applicability and usefulness across a variety of practice settings.

      Supplementary data

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