nitinol and Esophageal-Diseases

A recently available, low profile, fully covered metal stent with symmetrical flares (FCMSF) may offer improved resistance to migration in esophageal disease.. A retrospective review of 58 esophageal FCMSF placed in 46 consecutive patients was performed. Pathologies included stricture and leak of benign and malignant etiology.. Sixteen of 58 stents (28%) were placed urgently/emergently. All patients had successful stent deployment with 0% stent-related hospital mortality. Postoperative morbidity occurred in 15 of the 58 (26%) stents and included stent migration, atrial fibrillation, pneumonia, pneumothorax, urinary retention, hemodynamic instability, and chronic obstructive pulmonary disease exacerbation. In patients with stricture (n=29), mean dysphagia scores were reduced from 3.1±0.6 preoperatively to 1.1±0.8 postoperatively (P<0.001). For leak, stent therapy (±drainage) avoided formal esophageal operation in 95% (21/22). Four stents (6.9%) were removed for stent migration, 2 of which migrated after adjuvant chemoradiation. Adjuvant chemoradiation therapy was an independent risk factor for stent migration (odds ratio=1.6; P=0.02) by multivariable regression analysis. The mean duration of stent therapy was 65±62 days for stricture (27/34 remain in situ) and 57±57 days for leak (10/22 remain in situ). The median hospital length of stay was 2 days.. FCMSF provide a safe and effective therapy for both benign and malignant esophageal dysphagia and leaks. The symmetrical property may contribute to the overall low observed migration rate while still allowing for simple and safe stent retrieval.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Coated Materials, Biocompatible; Elective Surgical Procedures; Esophageal Diseases; Female; Follow-Up Studies; Humans; Male; Middle Aged; Prosthesis Design; Retrospective Studies; Stents; Treatment Outcome

Secure access and reliable closure is paramount in the setting of transesophageal mediastinal endoscopic surgery. The purpose of this study was to develop a secure transesophageal access technique and to evaluate the feasibility, safety, and efficacy of a novel covered, self-expanding, retractable stent for closure of 15-mm esophageal defects.. Fifteen-millimeter esophagotomies were created in 18 domestic pigs using needle knife puncture and balloon dilatation or a blunt dissection technique. Six animals were randomly assigned to open surgical repair and six animals to endoscopic closure using a self-expanding, covered, nitinol stent (Danis SX-ELLA stent, ELLA-CS) in a nonsurvival setting. Pressurized leak tests were performed on all closures. Six animals underwent transesophageal endoscopic mediastinal interventions and survived for 17 days. Stents were extracted at day 10.. Nonsurvival experiments revealed two bleeding complications associated with the needle-knife access technique, while blunt-dissection mediastinal access was not associated with any complications. Leak test results were not different for stent compared to surgical closures. All survival animals were found to have complete closure and adequate healing of the esophagotomies. No leakage or infectious complication occurred.. Blunt dissection achieves safe access into the mediastinum. Stent closure achieves similar leak test results compared to surgical closure and results in adequate sealing and wound healing of 15-mm esophageal defects.

Topics: Alloys; Animals; Biopsy; Disease Models, Animal; Equipment Design; Esophageal Diseases; Esophagoscopy; Feasibility Studies; Mediastinum; Natural Orifice Endoscopic Surgery; Pleura; Radiography, Thoracic; Random Allocation; Stents; Surgical Instruments; Swine

Fully covered esophageal self-expandable metal stents (FCSEMSs) are thought to induce less mucosal hyperplasia and are potentially removable. They may constitute an attractive alternative for the treatment of benign esophageal diseases.. To evaluate the efficacy and safety of FCSEMSs in the treatment of benign esophageal diseases.. Patients referred for management of benign esophageal disease underwent placement of an FCSEMS and were entered into a prospective database and analyzed retrospectively for clinical response, efficacy, and morbidity.. Two tertiary care centers with long-standing experience in the management of benign esophageal strictures.. Between January 2006 and September 2007, 35 patients (mean age 61 years, range 20-85 years) underwent FCSEMS placement for benign esophageal diseases at 2 tertiary academic medical centers. There were 19 patients with benign esophageal strictures and 16 patients with leaks/perforations.. Temporary placement of FCSEMS until stricture resolution.. Clinical response, efficacy, and morbidity.. Indications for stent placement were esophageal leak/fistulae (n = 12), refractory benign strictures (n = 10), anastomotic strictures (n = 7), perforations (n = 4), and radiation-induced strictures (n = 2). Immediate complications were chest pain (2 patients), stent migration (2 patients), dysphagia (1 patient), respiratory compromise (1 patient), and arrhythmia (1 patient). Long-term complications included recurrent dysphagia (6 patients), aspiration pneumonia (2 patients), globus sensation (2 patients), abdominal pain (2 patients), and fever (1 patient). Stent migration was observed in 12 patients (34%). After placement, dysphagia scores at 1 month improved significantly from 3.1 ± 1.0 to 1.2 ± 1.3 (P < .0001). A total of 11 of 35 patients (31%) were treated successfully. Specifically, 21% of patients with refractory strictures and 44% of patients with leaks/fistulae had successful long-term outcomes without any need for reinterventions. All stents were retrieved successfully, except for 1 stent, which fractured and was retrieved in 2 pieces without any complications.. Use of FCSEMSs for benign esophageal conditions was associated with frequent stent migration and long-term improvement in only one third of patients. Further investigation is required before recommending FCSEMS placement to treat benign diseases of the esophagus and to further characterize the subgroup that might benefit from these interventions.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Coated Materials, Biocompatible; Deglutition Disorders; Device Removal; Endoscopy, Gastrointestinal; Esophageal Diseases; Female; Follow-Up Studies; Humans; Male; Middle Aged; Prospective Studies; Prosthesis Design; Stents; Time Factors; Treatment Outcome; Young Adult