Project description:Background and aimsEndoscopic stent placement in luminal GI strictures is not always feasible with traditional stents. For example, standard luminal stent delivery catheters may not successfully traverse severe strictures, and enteral stents may not be suitable for sites in the GI tract that pose significant adverse events if downstream migration were to occur. We demonstrate extrabiliary applications of specialized, fully covered antimigration biliary metal stents.MethodsThis is a retrospective series of 4 patients with different benign and malignant luminal GI strictures who underwent placement of fully covered antimigration biliary metal stents in different configurations as a bridge or destination therapy.ResultsLuminal obstruction resolved without adverse events in all cases.ConclusionsAlthough off label, extrabiliary use of these stents can successfully address scenarios of complex luminal pathology. To compensate for the small stent caliber, two stents may be placed side by side in a double-barrel configuration. Strict diet modifications are necessary when applying this therapeutic paradigm.
Project description:Partially covered self-expandable metallic esophageal stent (SEMS) placement is the most frequently applied palliative treatment in esophageal cancer. Structural characterization of explanted 16 nitinol-polyurethane SEMS (the group of 6 females, 10 males, age 40-80) was performed after their removal due to dysfunction. The adverse bulk changes in the polymer structure were identified using differential scanning calorimetry (DSC), differential mechanical thermal analysis (DMTA), and attenuated total reflectance infrared spectroscopy (ATR-IR) and discussed in terms of melting point shift (9 °C), glass-transition shift (4 °C), differences in viscoelastic behavior, and systematic decrease of peaks intensities corresponding to C-H, C═O, and C-N polyurethane structural bonds. The scanning electron and confocal microscopic observations revealed all major types of surface degradation, i.e., surface cracks, peeling off of the polymer material, and surface etching. The changes in the hydrophobic polyurethane surfaces were also revealed by a significant decrease in wettability (74°) and the corresponding increase of the surface free energy (31 mJ/m2). To understand the in vivo degradation, the in vitro tests in simulated salivary and gastric fluids were performed, which mimic the environments of proximal and distal ends, respectively. It was concluded that the differences in the degradation of the proximal and distal ends of prostheses strongly depend on the physiological environment, in particular stomach content. Finally, the necessity of the in vivo tests for SEMS degradation is pointed out.
Project description:BackgroundEndoscopic treatment of benign biliary strictures (BBS) can be challenging.ObjectiveTo evaluate the efficacy of fully covered self-expandable metal stents (FCSEMS) in BBS.MethodsNinety-two consecutive patients with BBS (chronic pancreatitis (n?=?42), anastomotic after liver transplantation (n?=?36), and post biliary surgical procedure (n?=?14)) were included. FCSEMS were placed across strictures for 6 months before endoscopic extraction. Early success rate was defined as the absence of biliary stricture or as a minimal residual anomaly on post-stent removal endoscopic retrograde cholangiopancreatography (ERCP). Secondary outcomes were the final success and stricture recurrence rates as well as procedure-related morbidity.ResultsStenting was successful in all patients. Stenting associated complications were minor and occurred in 22 (23.9%) patients. Migration occurred in 23 (25%) patients. Stent extraction was successful in all but two patients with proximal stent migration. ERCP after the 6 months stenting showed an early success in 84.9% patients (chronic pancreatitis patients: 94.7%, liver transplant: 87.9%, post-surgical: 61.5%) (p?=?0.01). Final success was observed in 57/73 (78.1%) patients with a median follow-up of 12?±?3.56 months. Recurrence of biliary stricture occurred in 16/73 (21.9%) patients.ConclusionsFCSEMS placement is efficient for patients with BBS, in particular for chronic pancreatitis patients. Stent extraction after 6 months indwelling, although generally feasible, may fail in a few cases.
Project description:Chronic pancreatitis (CP) related main pancreatic duct (MPD) stricture has been a challenge for endoscopists. Fully covered self-expandable metal stents (FC-SEMS) has been tried in CP patients, but the efficacy and safety are still controversial. Thus, we aim to compare the long-term clinical efficacy of FC-SEMS vs. plastic stent placement in persistent MPD strictures secondary to CP. Between 2007 and 2018, 80 chronic pancreatitis patients (58 males, median age 49 years), who underwent endoscopic placement of FC-SEMS (n = 26) and plastic stent (n = 54) for persistent MPD strictures after at least 3 months of initial single plastic stenting, were retrospectively analyzed during a median follow-up duration of 33.7 months. As a result, MPD stricture resolution rate was statistically higher in FC-SEMS group (87.0% vs. 42.0%, p < 0.001). Although immediate complications occurred similarly (38.5% vs. 37.0%, p = 0.902), spontaneous migration (26.9%) and de novo strictures (23.1%) were pronounced delayed complications in FC-SEMS group. Pain relief during follow-up was significantly higher in FC-SEMS group (76.9% vs. 53.7%, p = 0.046). The total procedure cost was similar in both groups ($1,455.6 vs. $1,596.9, p = 0.486). In comparison with plastic stent, FC-SEMS placement for persistent MPD strictures had favorable long-term clinical efficacy, with its typical complications like spontaneous migration and de novo strictures.
Project description:Background and purposeEndovascular treatment of vascular lesions has revolutionized the treatment of arterial pseudoaneurysms. We describe our experience in treating carotid or vertebral pseudoaneurysms with covered stents.Materials and methodsTen patients with carotid or vertebral pseudoaneurysms treated with self-expanding or balloon-expandable covered stents were retrospectively reviewed after we obtained institutional review board approval. Distal protection devices were not used. All patients except 1 received anticoagulation therapy. Antiplatelet therapy was used in 8 of 10 patients. Follow-up was performed from 5 days to 25 months. Patients were followed with digital subtraction angiography, CT angiography (CTA), and/or sonography (US).ResultsPseudoaneurysm occlusion was obtained in all 10 patients. None of the pseudoaneurysms recanalized during the follow-up period. One patient had a distal embolization to the middle cerebral artery despite anticoagulation and antiplatelet therapy. One patient who did not receive any anticoagulation had stent occlusion at 4.5 months. Anticoagulation was stopped after 6 months in 2 patients with persistent stent patency and no neurologic complications for >1 year. Both US and CTA were useful for extracranial stent surveillance. CTA was helpful for intracranial stent surveillance.ConclusionIn this small series, the use of covered stents allowed safe and effective treatment of pseudoaneurysms occurring in the cervical and cephalic segments of the carotid and vertebral arteries.
Project description:BACKGROUND:Chronic mesenteric ischemia (CMI) is the result of insufficient blood supply to the gastrointestinal tract and is caused by atherosclerotic stenosis of one or more mesenteric arteries in >?90% of cases. Revascularization therapy is indicated in patients with a diagnosis of atherosclerotic CMI to relieve symptoms and to prevent acute-on-chronic mesenteric ischemia, which is associated with high morbidity and mortality. Endovascular therapy has rapidly evolved and has replaced surgery as the first choice of treatment in CMI. Bare-metal stents (BMS) are standard care currently, although retrospective studies suggested significantly higher patency rates for covered stents (CS). The Covered stents versus Bare-metal stents in chronic atherosclerotic Gastrointestinal Ischemia (CoBaGI) trial is designed to prospectively assess the patency of CS versus BMS in patients with atherosclerotic CMI. METHODS/DESIGN:The CoBaGI trial is a randomized controlled, parallel-group, patient- and investigator-blinded, superiority, multicenter trial conducted in six centers of the Dutch Mesenteric Ischemia Study group (DMIS). Eighty-four patients with a consensus diagnosis of atherosclerotic CMI are 1:1 randomized to either a balloon-expandable BMS (Palmaz Blue with rapid-exchange delivery system, Cordis Corporation, Bridgewater, NJ, USA) or a balloon-expandable CS (Advanta V12 over-the-wire, Atrium Maquet Getinge Group, Hudson, NH, USA). The primary endpoint is the primary stent-patency rate at 24?months assessed with CT angiography. Secondary endpoints are primary stent patency at 6 and 12?months and secondary patency rates, freedom from restenosis, freedom from symptom recurrence, freedom from re-intervention, quality of life according the EQ-5D-5?L and SF-36 and cost-effectiveness at 6, 12 and 24?months. DISCUSSION:The CoBaGI trial is designed to assess the patency rates of CS versus BMS in patients treated for CMI caused by atherosclerotic mesenteric stenosis. Furthermore, the CoBaGI trial should provide insights in the quality of life of these patients before and after stenting and its cost-effectiveness. The CoBaGI trial is the first randomized controlled trial performed in CMI caused by atherosclerotic mesenteric artery stenosis. TRIAL REGISTRATION:ClinicalTrials.gov, ID: NCT02428582 . Registered on 29 April 2015.
Project description:BackgroundIt has been suggested that the benefits of drug-eluting stents compared to bare metal stents (BMS) have been overestimated in part because target lesion/vessel revascularization (TLR/TVR) rates in the BMS control group of these trials were spuriously high.MethodsWe used meta-analytic techniques to systematically compare clinical event rates among patients treated with BMS in trials where BMS were the experimental (BMS(experimental)) rather than the control (BMS(control)) intervention. MEDLINE searches were performed to identify eligible randomized trials comparing either drug-eluting stents with BMS(control) or BMS(experimental) with balloon angioplasty in patients with nonacute coronary artery disease. Trial characteristics and 6- to 12-month rates for death, myocardial infarction, TLR/TVR, and major adverse cardiac events were extracted and assessed.ResultsEligible trials yielded 50 BMS cohorts: 19 in the BMS(control) group (4046 patients) and 31 in the BMS(experimental) group (5068 patients). Summary death and infarction rates did not differ between groups. The summary TLR/TVR rates were 16.2% (95% CI 13.5-19.3) versus 13.8% (95% CI 12.0-15.7) in BMS(control) versus BMS(experimental) groups, respectively (P = .15). Among 39 BMS cohorts with < or = 250 patients, TLR/TVR rates were significantly higher in BMS(control) versus BMS(experimental) groups (18.9% [95% CI 16.0-22.2] vs 13.7% [95% CI 11.5-16.3], P = .01). There were no between-group differences among larger BMS cohorts (P = .98).ConclusionsAlthough overall clinical event rates did not differ in the BMS(control) and the BMS(experimental) groups, a higher rate of TVR/TLR was seen in the BMS(control) group among smaller trials.