Transmural Defects Research Articles

New generation endoscopic closure devices for full-thickness defects: a comparative pre-clinical study (with videos).

Endoscopic closure techniques are effective and safe in the management of transmural gastrointestinal defects. However, there is a paucity of data regarding their comparative effectiveness. This study aimed to compare the efficacy and safety of several new-generation, endoscopic closure devices in a pre-clinical model. We evaluated five commercially available devices: a through-the-scope clip (TTSC), an anchor-pronged TTSC, a suturing device, helical tacking system, and over-the-scope clip. We tested closure strength using an ex-vivo porcine model. Next, live animals underwent 15mm gastric and colonic perforations followed by immediate endoscopic closure with one of the devices. We assessed technical success, 7-day survival, time to complete closure, and National Aeronautical and Space Administration Task Load Index (NASA-TLX) task load index. A total of 60 ex-vivo closures were conducted (12 per device). The suturing device achieved a higher closure strength than all other devices (P < 0.05 for all comparisons). Technical success was achieved in 80% of cases, and 9 of 10 animals (90%) survived to 7days post-closure. The mean procedure time for the suturing device was longer than all other devices (P < 0.05 for all comparisons). The mean procedure time for the anchor-pronged TTSC was also faster than over-the-scope clip (P = 0.04). The total endoscopist NASA-TLX score for the suturing device and helical system were greater than all other devices (P < 0.05 for all comparisons). Each closure device varies significantly in closure strength, closure time, and ease of use. Optimal device selection will depend on defect size, anatomic location, the viability of the surrounding tissue, and endoscopist/technician expertise.

Indigenously modified endoluminal vacuum-assisted closure therapy for post-operative gastrointestinal transmural defects: Case series and review of literature.

A gastrointestinal (GI) transmural defect is defined as a total rupture of the GI wall and these defects can be divided into three main categories, including perforation, leaks and fistulae. Recognition of the specific classification of the defect is important for choosing the best therapeutic modality. We present a case series of patients with gastrointestinal transmural defects which were managed with indigenously modified endoluminal vacuum-assisted closure.

OGC SO27 - Management of oesophageal defects with Microtech VAC stents (MVS): A single centre case series

Abstract Background Oesophageal defects following cancer resection, dilatation or Boerhaave’s syndrome are increasingly managed with endoscopic approaches. Surgical management is associated with high morbidity and mortality. Pigtails stents (PS), oesophageal stents and negative pressure therapy (eso-sponge) have all been described with variation in efficacy. Microtech VAC stents (MVS) have emerged as a means of providing an oesophageal luminal stent and negative pressure to the mediastinum. Method Between June 2023 to June 2024, 19 MVS have been used in four patients with transmural oesophageal defects. Two patients had anastomotic leak (one was a quaternary referral) following Ivor Lewis Oesophagectomy. One patient had a perforation from a dilatation of a gastro-jejunostomy anastomotic stricture post-gastric bypass at another centre, then admitted as an emergency. One patient had Boerhaave’s syndrome. Results Four patients were treated with MVS. In two patients, one post dilatation perforation and one with Boerhaave’s, one MVS was sufficient to resolve the mucosal defect after seven and 11 days respectively. The other two patients with anastomotic leak required seven and 10 MVS respectively. In these patients MVS and antibiotics controlled mediastinitis, but did not completely resolve the mucosal defect. For chronic leak management MVS were exchanged for PS to enable ambulatory care. No complications with MVS changes within seven days. One patient had ingrowth of mucosa into the MVS after 11 days, but was successfully removed. Conclusion MVS therapy has been demonstrated to be safe and feasible in the management of oesophago-gastric perforations in a UK centre. Exchange of VS every 5-7 days does have additional burden to a busy endoscopy unit. No adverse events were observed.

Endoscopic vacuum therapy for gastrointestinal transmural defects: a literature review.

Endoscopic vacuum therapy (EVT) has emerged as a transformative approach for managing gastrointestinal (GI) transmural defects, offering a less invasive and more promising alternative to surgery. Initially developed to address anastomotic leaks after rectal surgery, the application of EVT has expanded to include other locations within the GI tract. This review investigated the principles, indications, procedures, outcomes, challenges, and future perspectives of EVT for the management of GI transmural defects. In conclusion, EVT has demonstrated favorable outcomes in GI defect closure, with reduced complications, shortened hospital stay, and decreased morbidity rates as compared with conventional treatments. Although EVT faces challenges in some specific anatomical locations and in managing severe complications such as major bleeding, ongoing advancements in technology and standardization efforts offer promise for broader indications and better outcomes. Future perspectives include exploring novel EVT devices, refining patient selection criteria and pre-emptive applications, and standardizing procedural protocols.

770. CLOSURE OF OESOPHAGEAL DEFECTS USING THE VACSTENT DEVICE: INITIAL INSIGHTS FROM THE LARGEST UK CASE SERIES

Abstract Introduction Oesophageal defects are associated with poor morbidity and mortality and often require prolonged hospitalisation and artificial nutrition. Existing endoscopic treatment modalities exhibit limitations. Covered stents are associated with a migration rate of up to 50% and closure with endoscopic clips is limited to simple defects. Vacuum therapy is a well understood and established surgical therapy to promote wound healing. Endoscopic Vacuum Therapy (EVT) utilises these principles in the management of transmural oesophageal defects. The VACstent GITM (MicroTech) is a novel device which synergistically incorporates the advantages of a fully covered oesophageal stent while concurrently employing EVT. This approach seals the defect while mitigating against stent migration through the vacuum effect. Luminal patency is also maintained which helps to preserve nutritional independence. Accelerated healing and enhanced nutrition are thought to help reduce morbidity and enhance patient quality of life. Methods This single-centre prospective case series describes outcomes for patients with transmural oesophageal defects treated with the VACstent GITM device. All procedures were performed with propofol sedation and fluoroscopic guidance. The VACstent GITM was exchanged every 5-7 days until endoscopic closure. A contrast study was used to confirm closure after which oral nutrition was restarted. The primary outcome was clinical success, defined as the endoscopic and radiological evidence of defect closure. Secondary outcomes included number of stent exchanges, technical success, and the adverse event (AE) rate. Results The VACstent GITM device was used for seven patients between October 2023 and February 2024. Four patients had anastomotic leaks with three having iatrogenic perforations. The mean patient age was 60 (± 19.3) years with 57% of the patient cohort being male. The clinical success rate was 86% with a technical success rate of 100% and a median defect closure time of 13 (± 6.6) days. A median number of 1 stent exchanges was required. The median defect size was 8mm (± 6.2). There were no reported AEs. All patients were able to successfully come of artificial nutrition. Conclusion This case series illustrates the safety and efficacy of the VACstent for the treatment of a heterogenous group of oesophageal defects. To our knowledge this represents the largest series in a cohort of patients from the United Kingdom. Larger scale comparative studies incorporating a more diverse patient cohort will further clarify the potential of the VACstent device in reducing the necessity for major surgical interventions in this complex and challenging patient population. It will also help to refine future treatment algorithms for oesophageal defect management.

303. VACUUM-STENT TREATMENT FOR TRANSMURAL DEFECTS IN THE UPPER GASTRO-INTESTINAL TRACT: CASE SERIES AND NEW INSIGHTS IN A TERTIARY REFERRAL CENTER

Abstract Background Transmural defects in the upper gastro-intestinal (GI) tract are associated with severe morbidity and mortality. Endoscopic vacuum therapy (EVT) has recently been established as promising endoscopic treatment option for such defects and is most often applied using endoscopically placed vacuum-sponges. The vacuum-stent is a novel device to apply EVT, combining the advantages of negative pressure wound therapy and an intraluminal stent, allowing for oral intake. Methods The aim of this prospective cohort study is to describe the experiences of, and lessons learned by a tertiary referral center with EVT experience since 2018, regarding the vacuum-stent for transmural defects in the upper GI tract. All patients treated with a vacuum-stent between November 2022 and October 2023 were included. Outcome measures included successful defect closure, reasons of treatment failure, adverse events and strictures. Results 31 patients were included. Baseline characteristics and outcomes are displayed in Table 1. Success rates of combined vacuum-stent and –sponge treatment and vacuum-stent treatment alone were respectively 83% and 78%. In this cohort, some notable reasons of failure were observed: a defect too close to the upper esophageal sphincter (UES), inadequate vacuum on the esophago-jejunal anastomosis, a carcinoma at a persisting perforated ulcer, and adverse events. Two adverse events occurred (6%): two patients developed a secondary defect at the site of the proximal vacuum-stent flange, of whom one had a cervical anastomosis with a narrow proximal esophagus and one Boerhaave syndrome. Three out of four patients with a severe structure had underwent a McKeown esophagectomy. Conclusion The vacuum-stent is a valuable treatment option for AL after Ivor Lewis esophagectomy, Boerhaave syndrome and iatrogenic defects with success rates of 78-83%. Treating cervical anastomotic leaks is not recommended by us, due to the narrow lumen of the proximal esophagus, the proximity of the UES and high risk of severe strictures. Furthermore, caution is recommended in case of a narrow esophagus. In our experience, vacuum-stent and –sponge treatment complement each other and might be indicated in different situations. Sharing experiences on the topic is important to assess the best techniques and indications, to be able to reach the full potential of the vacuum-stent and further increase the success rate.

Endoluminal Vacuum Therapy Using a New "Fistula Sponge" in Treating Defects of the Upper Gastrointestinal Tract-A Comparative, Retrospective Cohort Study.

Background and Objectives: Anastomotic insufficiencies (AI) and perforations of the upper gastrointestinal tract (uGIT) result in high morbidity and mortality. Endoscopic stent placement and endoluminal vacuum therapy (EVT) have been established as surgical revision treatment options. The Eso-Sponge® is the only licensed EVT system with limitations in treating small defects (<10 mm). Therefore, a fistula sponge (FS) was developed for the treatment of such defects as a new therapeutic approach. The aim of this study was to evaluate both EVT options' indications, success rates, and complications in a retrospective, comparative approach. Materials and Methods: Between 01/2018 and 01/2021, the clinical data of patients undergoing FS-EVT or conventional EVT (cEVT; Eso-Sponge®, Braun Melsungen, Melsungen, Germany) due to AI/perforation of the uGIT were recorded. Indication, diameter of leakage, therapeutic success, and complications during the procedure were assessed. FSs were prepared using a nasogastric tube and a porous drainage film (Suprasorb® CNP, Lohmann & Rauscher, Rengsdorf, Germany) sutured to the distal tip. Results: A total of 72 patients were included (20 FS-EVT; 52 cEVT). FS-EVT was performed in 60% suffering from AI (cEVT = 68%) and 40% from perforation (cEVT = 32%; p > 0.05). FS-EVT's duration was significantly shorter than cEVT (7.6 ± 12.0 d vs. 15.1 ± 14.3 d; p = 0.014). The mean diameter of the defect was 9 mm in the FS-EVT group compared to 24 mm in cEVT (p < 0.001). Therapeutic success was achieved in 90% (FS-EVT) and 91% (cEVT; p > 0.05). Conclusions: EVT comprises an efficient treatment option for transmural defects of the uGIT. In daily clinical practice, fistulas < 10 mm with large abscess formations poses a special challenge since intraluminal cEVT usually is ineffective. In these cases, the concept of extraluminal FS placement is safe and effective.

224. A SUCCESSFUL CASE OF VACUUM-STENT TREATMENT FOR BOERHAAVE SYNDROME

Abstract Background Boerhaave syndrome is a rare disease, associated with severe morbidity and mortality. Endoscopic vacuum therapy (EVT) has gained a greater role in the treatment of transmural defects in the upper gastrointestinal tract, including Boerhaave syndrome. Recently, a vacuum-stent was introduced as a new device to apply EVT. While allowing for oral intake of a soft diet, this device combines the benefits of negative pressure wound therapy and an intraluminal stent. Methods This video describes a patient with Boerhaave syndrome, successfully treated with a vacuum-stent, including the technical aspects of the technique. First, a guidewire was placed and the vacuum-stent was advanced over the guidewire and introduced into the esophagus. The vacuum-stent was placed over the defect and deployed using the distal release system. Lastly, the vacuum-stent was connected to a vacuum pump, which was set to a pressure of -125 mmHg on the day of placement and -75 mmHg from the second day on. Generally, a vacuum-stent was removed after 7 days. If the defect persisted, another vacuum-stent was placed. Case/Results: A 36-year-old male presented with severe abdominal pain after emesis. CT-scan showed suspicion of a defect in the distal esophagus and an endoscopy was performed. Endoscopy showed a defect of 2 cm in length with moderate degree of debris. It was decided to initiate treatment with vacuum-stent. The vacuum stent was exchanged once per week and after a total of 31 days, the defect was closed, confirmed by CT-scan with oral contrast. During treatment, oral intake was extended to a soft diet. One day after removal, the patient resumed oral intake and was discharged. Conclusions The vacuum-stent seems to be a safe and possibly organ-saving treatment option for transmural defects in the upper gastrointestinal tract, including Boerhaave syndrome. Link to video: https://we.tl/t-IA5oM70TX5

218. INITIAL EXPERIENCES WITH VACUUM-STENT AS NOVEL TREATMENT OPTION FOR TRANSMURAL DEFECTS IN THE UPPER GASTRO-INTESTINAL TRACT: A SINGLE-CENTER CASE SERIES

Abstract Background Transmural defects in the upper gastro-intestinal (GI) tract (anastomotic leak, Boerhaave syndrome, iatrogenic defects) are associated with severe morbidity. Recently, a vacuum-stent was introduced as novel treatment device, combining the benefits of negative pressure wound therapy and an intraluminal stent, while allowing for oral intake of a soft diet. The aim of this prospective case series was to describe the first experiences with the vacuum-stent for the upper GI tract in an academic hospital. Methods All patients treated with a vacuum-stent between March 2022 and March 2023 were included. Patients who were already treated with vacuum-sponge and received a vacuum-stent when it became available were also included. Outcome measures included successful closure of the defect, adverse events, number of EVT-related endoscopies and treatment duration. Results 23 patients were included (18 male, median age 65 years). Fourteen patients had anastomotic leakage after esophagectomy, five patients an iatrogenic perforation and four had Boerhaave syndrome. Twelve patients were treated with vacuum-stent alone and eleven with a combination of vacuum-stent and vacuum-sponge (Table 1), which was mostly due to the later availability of or limited experience during the implementation period of the vacuum-stent. Success rate was 91%, median 4 (IQR 3–8) EVT-related endoscopies were performed during median 14 (IQR 12–31) days of treatment in successful cases. During median 120 (IQR 15–221) days follow-up, four patients developed an anastomotic stricture treated with endoscopic dilation. No other adverse events were observed. Conclusion The vacuum-stent combines the benefits of EVT and an intraluminal stent and shows great feasibility and efficacy in treatment of transmural defects in the upper GI tract. More research is necessary, as this device could possibly prevent major (re-)surgery in these patients.

Successful endoscopic management of a large esophageal defect due to Boerhaave syndrome with endoscopic vacuum therapy using vacuum sponge and vacuum stent

Video 1Successful endoscopic management of a large esophageal defect due to Boerhaave syndrome with endoscopic vacuum therapy using EsoSponge and VACStent.

Vacuum-stent: A combination of endoscopic vacuum therapy and an intraluminal stent for treatment of esophageal transmural defects.

Endoscopic vacuum therapy (EVT) has gained a greater role in management of transmural defects in the upper gastrointestinal (GI) tract, including anastomotic leakage and esophageal perforation (e.g. Boerhaave syndrome and iatrogenic causes). The vacuum-stent is a new treatment modality, combining the benefits of EVT and an intraluminal stent. This prospective case series describes the first ten cases of a transmural defect in the upper GI tract treated with a vacuum-stent in a tertiary referral center. All patients signed informed consent for prospective registration of relevant data on treatment and outcomes in a specially designed database. Outcome parameters were successful closure of the defect, number of endoscopies, duration of treatment and adverse events. In total, ten patients treated with a vacuum-stent were included. Eight patients had anastomotic leakage after esophageal resection, of whom six were treated with vacuum-sponge and vacuum-stent, and two with vacuum-stent only. One patient had Boerhaave syndrome, treated with vacuum-sponge and vacuum-stent, and one had an iatrogenic perforation during pneumodilation for achalasia, treated with vacuum-stent only. Success rate was 100%, requiring a median of 5 (IQR 3-12) EVT-related endoscopies with a treatment course of median 18 (IQR 12-59) days. One patient developed an esophageal stricture, but no other vacuum-stent related adverse events were observed. The vacuum-stent, which combines benefits of EVT and an intraluminal stent, shows great feasibility and efficacy in treatment of transmural defects in the upper GI tract. Future studies should point out whether this device can prevent major (re-)surgery in these patients.

Homemade endoscopic vacuum therapy device for the management of transmural gastrointestinal defects.

Endoscopic vacuum therapy (EVT) possesses a unique mechanism of action providing a less invasive alternative for the management of transmural gastrointestinal defects (TGID). This study evaluates the efficacy and safety of a novel homemade EVT (H-EVT) for the treatment of TGID. Retrospective multicenter study including patients who underwent H-EVT for TGID between January 2019 and January 2022. Main outcomes included technical and clinical success as well as safety outcomes. Subgroup analyses were included by defect location and classification. Logistic regression analyses were performed to determine predictors for successful closure. A total of 144 patients were included. Technical success was achieved in all patients, with clinical success achieved in 88.89% after a mean of 3.49 H-EVT exchanges over an average of 23.51 days. After excluding 10 cases wherein it was not possible to achieve negative pressure, successful closure occurred in 95.52% of patients. Time to clinical success was less for defects caused by endoscopic (hazard ratio [HR] 0.63; 95% confidence interval [CI] 0.33-1.20) compared to surgical procedures and for patients with simultaneous intracavitary and intraluminal H-EVT placement (HR 0.70; 95% CI 0.55-0.91). Location and classification of defect did not impact clinical success rate. Simultaneous placement of both an intraluminal and intracavitary H-EVT (odds ratio 3.08; 95% CI 1.19-7.95) was a significant predictor of clinical success. Three device-related adverse events (2.08%) occurred. The use of the H-EVT is feasible, safe, and effective for the management of TGID.

Feasibility and efficacy of endoscopic purse-string suture-assisted closure for mucosal defects induced by endoscopic manipulations.

Large or transmural defects induced by gastrointestinal endoscopic manipulations are difficult to close, although complete closure is recommended for better recovery. Endoscopic purse-string assisted suturing (EPSS) has been used in clinical practice and has proven to be an effective and safe technique for the closure of large mucosal defects. However, details regarding the efficacy of endoscopic pre-purse-string suture (P-EPSS) are unknown, especially that it offers several advantages over conventional EPSS (C-EPSS). To elucidate the outcomes of EPSS-assisted closure in different clinical situations, and evaluate the efficacy of P-EPSS. This retrospective observational study included a total of 180 patients who underwent closure assisted by P-EPSS (n = 63) or C-EPSS (n = 117) between July 2014 and June 2020. The P-EPSS and C-EPSS groups were compared and the intergroup differences in aspects such as the lesion size, location, and mor-phology, incidence of complete closure, intraoperative perforation, and delayed adverse events were evaluated. Data on the features and clinical course of cases with adverse events were collected for further analysis. Patients with lesion size larger than 3 cm, lesions located at the fundus of stomach, or submucosal tumors originating from the deep mucosa were more likely to undergo P-EPSS-assisted closure. The P-EPSS group showed a sign-ificantly higher proportion of intraoperative perforation (56% vs 17%) and a much shorter procedure time (9.06 ± 6.14 min vs 14.84 ± 7.25 min). Among adverse events, the incidence of delayed perforation (5% vs 4%; P = 0.82) and delayed bleeding (3% vs 4%; P = 0.96) did not differ significantly between the groups. Multivariate analysis revealed that lesions with incomplete closure [odds ratio (OR) = 21.33; 95% confidence interval (CI): 5.45-83.45; P < 0.01] or size greater than 3 cm (OR = 3.14; 95%CI: 1.08-9.18; P = 0.039) showed a statistical tendency to result in an increase in delayed adverse events. The present study revealed that EPSS could achieve secure complete closure of mucosal defect. P-EPSS could shorten the procedure and yield complete closure of mucosal defects. Rather than closure-type selection, incomplete closure or lesion size larger than 3 cm were associated with worse outcomes.

Treatment of esophageal leakages with the Microtech®-VAC-Stent: a monocentric early experience of three cases.

Endoscopic approaches in the treatment of transmural esophageal defects, either after esophageal resection or due to perforation, have demonstrated convincing feasibility. Surgical options are limited and associated with high morbidity and mortality rates. Currently, internal endoscopic drainage with pigtail stents, self-expanding metal stent (SEMS), or endoscopic vacuum therapy (EVT) are options for first-line treatment. Here, we report the outcome of the recently developed combination of SEMS and EVT using the endoscopic Microtech®-VAC-Stent (EVS). Between June and July 2022, three consecutive patients (one female and two males) with esophageal transmural defects were treated with the Microtech®-VAC-Stent. Two patients suffered from an anastomotic leak after oncologic gastroesophageal surgery, and one patient presented with esophageal perforation due to Boerhaave syndrome. Three consecutive patients were successfully treated with EVS. In one patient, one EVS treatment was sufficient, whereas the other two patients needed two and six EVS exchanges. Exchanges were scheduled every 7 days and no procedural adverse events were observed. In line with the former case series, EVS therapy is a promising new approach for the treatment of esophageal leaks. Exchange of the EVS seems feasible every 7 days reducing interventions for the individual patient. Prospective studies comparing EVS with other endoscopic therapies are needed to define the best therapeutic approach.

S379 Successful Use of a Novel Through-the Scope Suturing Device to Close a Duodenal Fistula Caused by Foreign Body Penetration

Introduction: Endoscopic treatments have become vital in managing transmural gastrointestinal defects both as a first-line and rescue treatment. The latest advances in interventional endoscopy have made a paradigm shift in managing these defects from surgery to minimally invasive endoscopic procedures. We present a unique presentation of a perforation caused by foreign body ingestion (FBI), leading to a chronic duodenal fistula that was treated with a novel through the scope suturing device (X-Tack Endoscopic HeliX Tacking System). Case Description/Methods: A 28-year-old male presented with a 4-week history of intermittent right upper quadrant abdominal pain associated with high-grade fevers. He had a past medical history and multiple episodes of FBI in the past.CT scan of the abdomen and pelvis revealed a large (14.2cm X 10.7cm) multiloculated liver abscess(Figure A). It also showed an impacted foreign body in the duodenum (Figure B) and multiple foreign bodies in the small intestine (Figure C). An EGD was performed, which revealed a spork in the second part of the duodenum (Figure D), which was removed using a snare(Figure E). A chronic-appearing fistulous tract was visualized at the duodenal sweep(Figure F). We decided to close the defect with a novel through-the-scope suturing device. Four HeliX Tacks were placed approximating the defect, and the suture was cinched with the endoscope cinching device. After deployment of the sutures, there appeared to be a residual opening; a second X-Tack with four HeliX Tacks was placed, but unfortunately, the suture broke. Finally, the third set of Helix Tack was placed, approximating the residual defect. After deployment, the fistulous tract appeared to be closed (Figure G). A follow-up CT scan with contrast revealed no residual duodenal leakage, and the patient improved clinically. Discussion: Our case exhibits a rare presentation of chronic contained duodenal perforation successfully treated with the help of a through-the-scope suturing device. This novel technique has several advantages over the traditional through-the-scope (TTS) and over-the-scope clips (OTS). It allows a suture-based deep submucosal/intramuscular fixation through a standard scope. This technique is superior for the closure of large mucosal defects as compared to traditional TTS clips. In addition, this device has improved accuracy and simplicity without the need for endoscope withdrawal for device loading. It is less invasive than surgery and more appropriate for clinically stable patients. https://tinyurl.com/ACGAbstractS379Figure 1.: (A) Liver Abscess in the Right Lobe of the Liver (B) Curved Metallic Body in 2nd and 3rd part of Duodenum (C) Small metallic bodies in the small intestine (D) Metallic Spork In the duodenum (E) Removal of Spork with a snare Image (F) Chronic Fistulous Tract in Duodenum (G) Endoscopic Closure of the Fistulous Tract

Management of Esophago-Gastric Anastomotic Leak with Endoscopic Vacuum Therapy- A Case Report and Review of Literature

Transmural defects of the upper gastrointestinal (UGI) tract can be either leaks, perforations or fistulae. Endoscopic vac is a good option for management for localized leaks where stent placement is not feasible. We present a case of a 31-year-old lady who was operated for strangulated Bochdalek hernia with partial gastrectomy with esophago-gastric anastomosis. She then underwent 2 sittings of endo vac placement for management of an anastomotic leak with mediastinitis. She was followed up on outpatient basis with imaging and interval endoscopies. Post 6 months of the procedure, patient is well and is on full oral feeds.

Application of Biosheets as Right Ventricular Outflow Tract Repair Materials in a Rat Model

PurposesWe report the experimental use of completely autologous biomaterials (Biosheets) made by “in-body tissue architecture” that could resolve problems in artificial materials and autologous pericardium. Here, Biosheets were implanted into full-thickness right ventricular outflow tract defects in a rat model. Their feasibility as a reparative material for cardiac defects was evaluated.MethodsAs the evaluation of mechanical properties of the biosheets, the elastic moduli of the biosheets and RVOT-free walls of rats were examined using a tensile tester. Biosheets and expanded polytetrafluoroethylene sheet were used to repair transmural defects surgically created in the right ventricular outflow tracts of adult rat hearts (n = 9, each patch group). At 4 and 12 weeks after the operation, the hearts were resected and histologically examined.ResultsThe strength and elastic moduli of the biosheets were 421.3 ± 140.7 g and 2919 ± 728.9 kPa, respectively, which were significantly higher than those of the native RVOT-free walls (93.5 ± 26.2 g and 778.6 ± 137.7 kPa, respectively; P < 0.005 and P < 0.001, respectively). All patches were successfully implanted into the right ventricular outflow tract-free wall of rats. Dense fibrous adhesions to the sternum on the epicardial surface were also observed in 7 of 9 rats with ePTFE grafts, whereas 2 of 9 rats with biosheets. Histologically, the vascular-constructing cells were infiltrated into Biosheets. The luminal surfaces were completely endothelialized in all groups at each time point. There was also no accumulation of inflammatory cells.ConclusionsBiosheets can be formed easily and have sufficient strength and good biocompatibility as a patch for right ventricular outflow tract repair in rats. Therefore, Biosheet may be a suitable material for reconstructive surgery of the right ventricular outflow tract.

Futuristic Developments and Applications in Endoluminal Stenting.

Endoscopic stenting is a well-established option for the treatment of malignant obstruction, temporary management of benign strictures, and sealing transmural defects, as well as drainage of pancreatic fluid collections and biliary obstruction. In recent years, in addition to expansion in indications for endoscopic stenting, considerable strides have been made in stent technology, and several types of devices with advanced designs and materials are continuously being developed. In this review, we discuss the important developments in stent designs and novel indications for endoluminal and transluminal stenting. Our discussion specifically focuses on (i) biodegradable as well as (ii) irradiating and drug-eluting stents for esophageal, gastroduodenal, biliary, and colonic indications, (iii) endoscopic stenting in inflammatory bowel disease, and (iv) lumen-apposing metal stent.

Cost-effective modified endoscopic vacuum therapy for the treatment of gastrointestinal transmural defects: step-by-step process of manufacturing and its advantages.

Video 1Cost-effective modified endoscopic vacuum therapy for GI transmural defects. Step-by-step process of manufacturing and potential advantages.1.Cut half gauze to the ideal size to cover only the fenestrated portion of the nasogastric tube (NGT).2.Wrap the gauze around the fenestrated portion of the NGT. The assistance of another person is important in this process.3.Cut the antimicrobial incise drape to match the size of the fenestrated portion of the NGT. Note that the incise drape is a very strong adhesive; therefore, 3 people are usually required to assemble it properly.4.Next, the suture is used to fix the gauze and drape to the NGT. Perform fixation of the modified sponge in 3 places. The first knot is in the proximal portion, just below the last fenestra of the NGT, as a marker of where the vacuum system starts. The second knot is at the distal end, to avoid migration of the modified sponge. The third knot is in the middle of the modified sponge, which is essential to serve as a guide during endoscopic placement. For example, in cases of defects without collection in which the sponge will be placed in an intraluminal position, it is ideal to place the vacuum system in the middle of the defect; in cases of intracavitary placement, it will work as a guide to how much of the modified sponge will be inside the collection.5.Finally, use a needle to make innumerable punctures in the modified sponge system to obtain adequate aspiration. An 18G needle is recommended because, in addition to having an adequate diameter, it is very sharp, which facilitates perforation of the modified sponge system.6.After creation of the modified endoscopic vacuum therapy, the functionality test is performed. Turn on the wall suction system, connect the distal end of the NGT to the tube of the canister connected on the wall, and place the NGT inside a bowl with a liquid solution. The aspiration of a large amount of liquid indicates proper functioning of the modified endoscopic vacuum therapy system.7.The device is then ready to be positioned endoscopically in the patient. After proper positioning, connect the NGT to the suction tube to avoid migration of the device upon removal of the scope.8.In addition to the cost-effective device as described, in our practice we also use wall suction to reduce costs associated with the use of the vacuum machine.9.Use the antimicrobial incise drape to seal the connection between the NGT and the suction tube to avoid leakage within the connection.10.Last, owing to instability of the negative wall pressure, a 20F intravenous catheter is connected to the tube to maintain a negative pressure between -75 and -150mmHg, as confirmed by laboratory studies performed by our group.

The addition of flexible endoscopic suturing to stenting for the management of transmural esophageal wall defects: a single tertiary center experience.

Endoscopic stenting is the standard of care for full thickness esophageal wall defects. The aim of this study is to evaluate outcomes of endoscopic closure of esophageal defects using stenting, with or without endoscopic suturing. This is a single-center retrospective study of patients with esophageal wall defects who underwent endoscopic interventions. Outcomes of stenting with or without endoscopic suturing of the defect were assessed. Univariate and multivariate logistic regression models were used to examine factors associated with successful defect closure. One hundred and fourteen patients with esophageal wall defects underwent 254 endoscopies with an overall complete closure rate of 75.8%. Twenty-three (20.2%) patients underwent primary closure using endoscopic suturing and subsequent esophageal stenting, while 91 (79.8%) underwent esophageal stenting only. The dual modality group (versus the stent-only group) had similar defect closure rates (84.2 vs. 73.8%, p = 0.55) and time to stent migration (37 vs. 12.5days, p = 0.07), but was associated with longer procedure times (60 vs. 36min, p < 0.01) and fewer additional endoscopic procedures (13.6 vs. 43.2%, p = 0.01). Stent suturing significantly decreased migration (35.5 vs. 58.5%, p = 0.04), was associated with fewer additional endoscopies (15.4 vs. 50%, p < 0.01) and reduced need for additional stents (7.7 vs. 34.3%, p < 0.01). On multivariate analysis, chronic defects (> four weeks old) were 81% less likely to close compared to acute (≤ 4weeks) defects (OR 0.19, CI 0.04-0.77, p = 0.02), and large diameter stents (23mm) were associated with higher odds of defect closure (OR 3.36, CI 1.02-11.4, p = 0.04). Endoscopic treatment of esophageal wall defects is safe, effective, and more likely to be successful in acute defects using larger caliber stents. Stent suturing reduces migration, need for additional endoscopic procedures, and stent exchanges. Further comparative studies with larger cohorts are needed to validate our results.