Flared polyurethane-covered self-expandable nitinol stent for malignant biliary obstruction

PURPOSE: To determine the technical efficacy and safety of a flared polyurethane-covered self-expandable nitinol stent in the management of malignant biliary obstruction and to evaluate its clinical efficacy by estimating stent patency and patient survival rates. MATERIALS AND METHODS: Thirteen patients with common bile duct strictures (nonhilar) caused by malignant disease were treated by placement of 13 nitinol stents. The stents used include a flared section in the proximal portion (12 mm in diameter and 10 mm in length) and a section in the remnant portion that is fully covered with high-elasticity polyurethane, with an unconstrained diameter of 10 mm and a total length of 50-80 mm. Patient survival and stent patency rates were calculated with use of Kaplan-Meier survival analysis. The follow-up bilirubin and serum amylase and lipase levels were calculated, and the differences in means were evaluated with use of a Wilcoxon signed-rank test. The average follow-up duration was 22.9 weeks (range, 8-56 weeks). RESULTS: Placement was successful in all cases. The 30-day mortality rate was 0%. The survival rates were 38% and 24% at 20 and 50 weeks, respectively. Seventy-seven percent of study patients had adequate palliative drainage during their the remainder of their lives. The stent patency rates were 71% and 48% at 20 and 50 weeks, respectively. Three patients (23%) presented with stent occlusion requiring repeat intervention. There were no procedure-related complications such as proximal or distal migration. No complications occurred other than stent occlusion. One patient's stent was removed under endoscopic guidance 15 weeks after its insertion. Bilirubin levels had significantly decreased 1 week after stent insertion (P <.001). CONCLUSION: Preliminary results suggest that placement of a flared polyurethane-covered self-expandable nitinol stent is feasible and effective in achieving biliary drainage. The stents do not migrate, but there is tumor ingrowth into the flared portion of the stent. Treatment of a larger group of patients will be mandatory to validate these long-term results.     

Polyurethane-covered self-expandable nitinol stent for malignant biliary obstruction: preliminary results

Purpose: To evaluate the immediate and long-term results in ten patients with malignant biliary obstruction using a polyurethane-covered, self-expandable nitinol stent. Methods: A nitinol stent, fully covered with high-elasticity polyurethane, with an unconstrained diameter of 10 mm and a total length of 60–80 mm, was placed transhepatically under fluoroscopic guidance in ten patients. The length of the biliary obstruction varied between 30–50 mm. The follow-up examination included a clinical assessment, serum bilirubin measurement, and ultrasound examinations at one-month intervals in all patients. Results: Initial stent deployment was successful in eight patients. Two patients experienced proximal migration, which was solved by insertion of two, uncovered Wallstents. One patient had the stent removed after two weeks because of severe nausea and vomiting. One patient had delayed migration of the covered stent after 40 weeks. The follow-up duration was 3–40 weeks (Mean: 16.9 weeks). Seven patients died (3–26 weeks) and three patients survived (24–40 weeks). The bilirubin measurements in all patients had significantly decreased one week after stent insertion. The levels of amylase and lipase had did not increase after stent insertion. Conclusions: A polyurethane-covered, self-expandable nitinol stent can be used effectively and safely in the treatment of malignant biliary obstruction. The preliminary results are favorable, but there is a need for further large studies to determine both long-term survival and patency.     

Double-Layered PTFE-Covered Nitinol Stents: Experience in 32 Patients with Malignant Esophageal Strictures

We evaluated the effectiveness of a double-layered polytetrafluoroethylene (PTFE)-covered nitinol stent in the palliative treatment of malignant esophageal strictures. A double-layered PTFE-covered nitinol stent was designed to reduce the propensity to migration of conventional covered stent. The stent consists of an inner PTFE-covered stent and an outer uncovered nitinol stent tube. With fluoroscopic guidance, the stent was placed in 32 consecutive patients with malignant esophageal strictures. During the follow-up period, the technical and clinical success rates, complications, and cumulative patient survival and stent patency were evaluated. Stent placement was technically successful in all patients, and no procedural complications occurred. After stent placement, the symptoms of 30 patients (94%) showed improvement. During the mean follow-up of 103 days (range, 9–348 days), 11 (34%) of 32 patients developed recurrent symptoms due to tumor overgrowth in five patients (16%), tumor ingrowth owing to detachment of the covering material (PTFE) apart from the stent wire in 3 (9%), mucosal hyperplasia in 2 (6%), and stent migration in 1 (3%). Ten of these 11 patients were treated by means of placing a second covered stent. Thirty patients died, 29 as a result of disease progression and 1 from aspiration pneumonia. The median survival period was 92 days. The median period of primary stent patency was 190 days. The double-layered PTFE-covered nitinol stent seems to be effective for the palliative treatment of malignant esophageal strictures. We believe that the double-layer configuration of this stent can contribute to decreasing the stent’s migration rate.     

Percutaneous Placement of Self-Expandable Metallic Stents in Patients with Obstructive Jaundice Secondary to Metastatic Gastric Cancer after Gastrectomy

Objective

To evaluate the outcomes of patients undergoing percutaneous placements of a biliary stent for obstructive jaundice secondary to metastatic gastric cancer after gastrectomy.

Materials and Methods

Fifty patients (mean age, 62.4 years; range, 27-86 years) who underwent percutaneous placements of a biliary stent for obstructive jaundice secondary to metastatic gastric cancer after gastrectomy were included. The technical success rate, clinical success rate, complication rate, stent patency, patient survival and factors associated with stent patency were being evaluated.

Results

The median interval between the gastrectomy and stent placement was 23.1 months (range, 3.9-94.6 months). The 50 patients received a total of 65 stents without any major procedure-related complications. Technical success was achieved in all patients. The mean total serum bilirubin level, which had been 7.19 mg/dL ± 6.8 before stent insertion, decreased to 4.58 mg/dL ± 5.4 during the first week of follow-up (p < 0.001). Clinical success was achieved in 42 patients (84%). Percutaneous transhepatic biliary drainage catheters were removed from 45 patients (90%). Infectious complications were noted in two patients (4%), and stent malfunction occurred in seven patients (14%). The median stent patency was 233 ± 99 days, and the median patient survival was 179 ± 83 days. Total serum bilirubin level after stenting was an independent factor for stent patency (p = 0.009).

Conclusion

Percutaneous transhepatic placement of a biliary stent for obstructive jaundice secondary to metastatic gastric cancer after gastrectomy is a technically feasible and clinically effective palliative procedure.     

Endovascular treatment of peripheral artery disease with expanded PTFE-covered nitinol stents: interim analysis from a prospective controlled study

Purpose: Current covered peripheral stent designs have significant drawbacks in terms of stent delivery characteristics and flexibility. The aim of this study was to analyze the technical performance, safety and initial clinical efficacy of expanded polytetrafluoroethylene (PTFE)-covered nitinol stents for arteriosclerotic peripheral artery disease. Methods:Eighty-two patients underwent implantation of PTFE-covered nitinol stents for iliac and/or femoral obstructions. The study was conducted prospectively in seven European centers and one Canadian center. Patients were controlled clinically and by duplex ultrasound follow-up. Data up to discharge were collected in 79 patients. Seventy-four patients have thus far received 1 month follow-up and 32 patients, 6 month follow-up examinations. Results: The average lesion length measured 47 mm for the common and external iliac arteries and 50 mm for the femoral arteries. The mean severity of the stenoses was reduced from 94% to 4% in the iliac arteries and from 98% to 7% in the femoral arteries after stent placement and dilatation. One device deviation (inadvertent stent misplacement) and one puncture-related severe adverse event with formation of a pseudoaneurysm occurred. There were occlusions of the stent in five patients. No infections were noticed. Conclusion: The interim analysis of this trial using PTFE-covered nitinol stents indicates that a strategy using primary implantation of this stent type is technically feasible, has an acceptable safety profile and is effective from a short-term perspective.     

金属与塑料支架姑息性治疗恶性胆道梗阻疗效对比研究

目的 :比较经皮肝穿金属支架与塑料支架置入术姑息性治疗恶性梗阻性黄疸的临床疗效及开通时间 ,探讨两种支架治疗的适应证。方法 :对 45例金属支架与 3 4例塑料支架介入治疗恶性梗阻性黄疸的临床资料进行回顾性分析。结果 :两组术后对降低胆红素和改善临床症状均有明显疗效 ,选择病例以肝门部梗阻占多数。术后早期并发症较少 ,晚期并发症主要为支架阻塞。金属支架中位开通时间为 2 76d ,明显长于塑料支架的 112d(P <0 .0 1)。结论 :两种支架均能有效解除胆道梗阻 ,且对高位梗阻具有优势 ,适用于不宜手术者。金属支架开通期明显长于塑料支架 ,但价格较贵 ;估计生存期 >3个月者 ,宜选择金属支架 ;生存期 <3个月和 /或经济条件不许可者 ,可选用塑料支架     

Treatment of tracheobronchial obstruction with a polytetrafluoroethylene-covered retrievable expandable nitinol stent

PURPOSE: To evaluate the clinical effectiveness of polytetrafluoroethylene (PTFE)-covered retrievable expandable nitinol stents in tracheobronchial strictures. MATERIALS AND METHODS: With fluoroscopic guidance, PTFE-covered retrievable expandable nitinol stents were placed in 15 symptomatic patients with benign (n = 6) or malignant (n = 9) tracheobronchial strictures. Complications and improvement in respiratory status were evaluated. Stents were removed electively 6 months after placement in benign strictures or if complications occurred. Membrane degradation or separation from the wire mesh was evaluated in removed stents. RESULTS: A total of 17 stents were successfully placed and were well tolerated in all patients. Sputum retention, stent migration, and tissue hyperplasia occurred in 23.5% (n = 4), 17.6% (n = 3), and 17.6% (n = 3) of stents, respectively. A total of 11 stents were successfully removed electively 6 months after placement (n = 4) or when complications occurred (n = 7). All 11 such stents were removed without difficulty with use of standard techniques, antecedent balloon dilation being necessary in two cases as a result of tissue hyperplasia. No removed stent showed signs of membrane degradation, and two removed stents showed signs of membrane separation from the mesh. CONCLUSIONS: PTFE-covered retrievable expandable nitinol stents were effective in the treatment of tracheobronchial strictures. Stent removal was easy with use of standard techniques, and no removed stent showed evidence of membrane degradation.     

Percutaneous metallic stents in patients with obstructive jaundice due to hepatocellular carcinoma

PURPOSE: To evaluate the technical success and clinical efficacy of percutaneously placed self-expandable metallic stents in patients with obstructive jaundice due to hepatocellular carcinoma (HCC). MATERIALS AND METHODS: Fifteen men (mean age, 59.3 years) with obstructive jaundice resulting from HCC were treated with self-expandable metallic stents (28 stents in 19 sessions). The authors evaluated the technical success, clinical success (decrease of 30% of total serum bilirubin level or <2 mg/dL [34.2 micromol/L]), treatment efficacy according to lowest total serum bilirubin level, complications, and duration of stent patency. RESULTS: Technical success was achieved in all patients. Clinical success was achieved in 11 of the 15 patients (73%). After stent placement, seven patients (47%) had a low bilirubin level (<2 mg/dL [34.2 micromol/L]), three (20%) had an intermediate bilirubin level (2-10 mg/dL [34.2-171 micromol/L]), and five (33%) had a high bilirubin level (>10 mg/dL [171 micromol/L]). A low bilirubin level was achieved in all patients with Child-Pugh A disease and stage T2 or T3 HCC. Major complications such as hemobilia necessitating transfusion (n=1) or abscess formation (n=1) occurred in two of the 19 sessions (10%). The overall mean stent patency was 149.8 days (range, 12-790 days). The mean stent patency in patients with Child-Pugh class A disease (257.8 days) was significantly longer than that of patients with Child-Pugh class B and C disease (123.2 and 63 days, respectively) (P<.05). CONCLUSIONS: The percutaneous placement of a self-expandable metallic stent is a feasible and effective palliative treatment for patients with obstructive jaundice resulting from HCC, especially for those with Child-Pugh class A disease and stage T2 or T3 HCC.     

Short-term effects of a new intravascular nitinol stent in canine arteries

RATIONALE AND OBJECTIVES: To evaluate the short-term effects of a new nitinol stent on canine arteries. METHODS: Eighteen nitinol mesh stents were placed in abdominal aortas, common iliac arteries, and renal arteries of six dogs. Angiography was performed to evaluate the patency rates and structural changes of arteries at 1 day, 3 weeks, 4 weeks, and 10 weeks after stent insertion. Gross and light microscopic examinations were performed after angiography. RESULTS: On angiography, the patency rate was 100%, and no thrombosis was observed. All side branches from stented segments were patent. The mean neointimal thickness over and between stent wires was 94 and 167 microns. No difference was found between the aorta and the small vessels. Histologically, the neointima was covered with endothelium and was composed of subintimal fibrosis with mild inflammation. CONCLUSIONS: The new type of nitinol mesh stent showed a high patency rate, with no thrombosis and relatively thin neointimal proliferation.     

Obstruction of the lacrimal system: treatment with a covered,retrievable, expandable nitinol stent versus a lacrimal polyurethane stent

PURPOSE: To compare the clinical effectiveness of a covered nitinol stent with that of a polyurethane stent for treatment of lacrimal system obstructions. MATERIALS AND METHODS: A nitinol stent was knit from a single thread of 0.1-mm nitinol wire in a tubular configuration and was covered by dipping the stent into a polyurethane solution. The stent was 4 mm in diameter and 30 or 35 mm long. With fluoroscopic guidance, a covered nitinol stent (n = 33, group A) or a polyurethane stent (n = 35, group B) was placed in 68 patients. The following items were evaluated retrospectively: technical success, procedure time, cumulative patency rate, and complications. An unpaired Student t test was used to analyze the difference between the procedure times. Kaplan-Meier survival curves and a log-rank test were used to compare the cumulative patency rates. RESULTS: Stent placement was technically successful in 31 (94%) of 33 patients in group A and in all 35 (100%) patients in group B. After stent placement, all patients showed resolution of epiphora. Average procedure time was 400 seconds (range, 270-900 seconds) in group A and 260 seconds (range, 150-900 seconds) in group B. The difference between the procedure times was statistically significant (P =.0003). During the mean follow-up period of 40 months, there was recurrence of epiphora in 30 of 31 patients in group A and 26 of 35 patients in group B. The difference of the cumulative patency rates was statistically insignificant (P =.2). CONCLUSION: Although the polyurethane stent used for treatment seemed to be more effective than the nitinol stent, selection of these stents for placement should be made with caution, because the long-term patency rates are not encouraging.     

Elastic deformation properties of implanted endobronchial wire stents in benign and malignant bronchial disease: A radiographic in vivo evaluation

PURPOSE: To evaluate the long-term mechanical behavior in vivo of expandable endobronchial wire stents, we imaged three different prostheses in the treatment of tracheobronchial disease. METHODS: Six patients with bronchial stenoses (three benign, three malignant) underwent insertion of metallic stents. Two self-expandable Wallstents, two balloon-expandable tantalum Strecker stents and two self-expandable nitinol Accuflex stents were used. Measurements of deformation properties were performed during voluntary cough by means of fluoroscopy, at 1 month and 7-10 months after implantation. The procedures were videotaped, their images digitized and the narrowing of stent diameters calculated at intervals of 20 msec. RESULTS: After stent implantation all patients improved with respect to ventilatory function. Radial stent narrowing during cough reached 53% (Wallstent), 59% (tantalum Strecker stent), and 52% (nitinol Accuflex stent) of the relaxed post-implantation diameter. Stent compression was more marked in benign compared with malignant stenoses. In the long term permanent deformation occurred with the tantalum Strecker stents; the other stents were unchanged. CONCLUSION: Endobronchial wire stents can be helpful in the treatment of major airway collapse and obstructing bronchial lesions. However, evidence of material fatigue as a possible effect of exposure to recurrent mechanical stress on the flexible mesh tube may limit their long-term use. This seems to be predominantly important in benign bronchial collapse.     

Treatment of complex arteriosclerotic lesions with nitinol stents in the superficial femoral and popliteal arteries: a midterm follow-up.

PURPOSE: To evaluate the effectiveness of nitinol stents in patients with short, complex lesions in the superficial femoral and popliteal arteries and to assess midterm results. MATERIALS AND METHODS: Self-expandable nitinol stents were implanted in 54 extremities in 44 patients to treat complex stenoses (n = 32) and occlusions (n = 22) in the superficial femoral and popliteal arteries. Follow-up was performed for 5-51 months to evaluate early thrombosis and midterm patency rates. Midterm patency rates were compared between the following: stenoses and occlusions, proximal and distal locations, good and poor runoff, and diabetic patients and nondiabetic patients. All patients underwent clinical investigation and color Doppler sonography after 1 month and 6 months and at 6-month intervals thereafter. If restenosis or stent thrombosis was suspected, intraarterial digital subtraction angiography of the superficial and popliteal arteries was performed. RESULTS: Percutaneous stent implantation was successful in all patients. The mean duration of follow-up was 27 months (range, 5-51 months). No thrombotic occlusion occurred within the first 4 weeks after stent implantation. The primary 3-year patency rate was 76%, and the secondary patency rate was 87%. Three-year primary patency rates were 65% for diabetic patients and 82% for nondiabetic patients. CONCLUSION: In patients with short, complex stenoses and occlusions, implantation of nitinol stents may have a positive impact on midterm results.     

No Advantage of Expanded Polytetrafluoroethylene and Fluorinated Ethylene Propylene–Covered Stents over Uncovered Nitinol Stents for Percutaneous Palliation of Malignant Infrahilar Biliary Obstruction: Results of a Single-Center Prospective Randomized Trial

PurposeTo prove that covered stents are more efficacious than uncovered stents regarding patency, safety, enabling of chemotherapy, and survival in percutaneous palliation of malignant infrahilar biliary obstruction.Materials and MethodsAfter failed endoscopic treatment, 154 patients with obstructive jaundice caused by unresectable infrahilar malignancy were randomly allocated to receive an expanded polytetrafluoroethylene and fluorinated ethylene propylene–covered or an uncovered nitinol stent. Occlusion rate, patency, and survival were assessed. Safety and clinical success in terms of chemotherapy were compared.ResultsThree patients were excluded post hoc. Fifteen patients died within 7 d and were excluded from patency analysis. Occlusion rates were 32% (21 of 66) for covered and 29% (20 of 70) for uncovered stents (P = .7). Estimated median patency durations were 308 d (95% confidence interval [CI], 178–438 d) for covered and 442 d (95% CI, 172–712 d) for uncovered stents (P = .1). Serious adverse events (P = 1.0) and 30-day mortality (P = .5) were equivalent between groups. At hospital discharge, median bilirubin reduction of 8 mg/dL was found in both groups (P < .001). In the covered stent group, 35 patients (48%) received palliative chemotherapy, vs 29 (37%) in the uncovered stent group (P = .2). Estimated median survival times were 96 days (95% CI, 68–124 d) with covered stents and 75 days (95% CI, 42–108 d) with uncovered stents (P = .6).ConclusionsIn malignant infrahilar biliary obstruction not amenable to endoscopy, no improvement in patency or survival with percutaneously placed covered stents could be confirmed. Covered and uncovered stent types exhibit similar safety profiles and clinical success rates.     

Elastic Deformation Properties of Implanted Endobronchial Wire Stents in Benign and Malignant Bronchial Disease: A Radiographic In Vivo Evaluation

Purpose: To evaluate the long-term mechanical behavior in vivo of expandable endobronchial wire stents, we imaged three different prostheses in the treatment of tracheobronchial disease. Methods: Six patients with bronchial stenoses (three benign, three malignant) underwent insertion of metallic stents. Two self-expandable Wallstents, two balloon-expandable tantalum Strecker stents and two self-expandable nitinol Accuflex stents were used. Measurements of deformation properties were performed during voluntary cough by means of fluoroscopy, at 1 month and 7–10 months after implantation. The procedures were videotaped, their images digitized and the narrowing of stent diameters calculated at intervals of 20 msec. Results: After stent implantation all patients improved with respect to ventilatory function. Radial stent narrowing during cough reached 53% (Wallstent), 59% (tantalum Strecker stent), and 52% (nitinol Accuflex stent) of the relaxed post-implantation diameter. Stent compression was more marked in benign compared with malignant stenoses. In the long term permanent deformation occurred with the tantalum Strecker stents; the other stents were unchanged. Conclusion: Endobronchial wire stents can be helpful in the treatment of major airway collapse and obstructing bronchial lesions. However, evidence of material fatigue as a possible effect of exposure to recurrent mechanical stress on the flexible mesh tube may limit their long-term use. This seems to be predominantly important in benign bronchial collapse.     

The use of SMARTeR stents in patients with biliary obstruction

AIM: The purpose of the study was to evaluate the percutaneous use of the new nitinol SMARTeR stents in patients with biliary obstruction. MATERIALS AND METHODS: Four stents were placed in three patients percutaneously under ultrasound and fluoroscopic guidance. RESULTS: The deployment of the stents was successful in all three patients. All stents maintained their patency and position after short-term follow-up. CONCLUSION: The nitinol SMARTeR stent is useful in the management of patients with biliary obstruction although accurate placement across the ampulla was found to be technically more difficult than with the Wallstent. Larger, long-term follow-up studies are required to evaluate the long-term patency of these new devices.     

Interventional Management of Malignant Colorectal Obstruction: Use of Covered and Uncovered Stents

Objective

We wanted to evaluate usefulness of uncovered stent in comparison with covered stent for the palliative treatment of malignant colorectal obstruction.

Materials and Methods

Covered (n = 52, type 1 and type 2) and uncovered (n = 22, type 3) stents were placed in 74 patients with malignant colorectal obstruction. Stent insertion was performed for palliative treatment in 37 patients (covered stent: n = 23 and uncovered stent: n = 14). In the palliative group, the data on the success of the procedure, the stent patency and the complications between the two groups (covered versus uncovered stents) were compared.

Results

The technical success rate was 89% (33/37). Symptomatic improvement was achieved in 86% (18/21) of the covered stent group and in 92% (11/12) of the uncovered stent group patients. The period of follow-up ranged from three to 319 days (mean period: 116±85 days). The mean period of stent patency was 157±33 days in the covered stent group and 165±25 days in the uncovered stent group. In the covered stent group, stent migration (n = 11), stent fracture (n = 2) and poor expansion of the stent (n = 2) were noted. In the uncovered stent group, tumor ingrowth into the stents (n = 3) was noted.

Conclusion

Self-expanding metallic stents are effective for relieving malignant colorectal obstruction. The rate of complications is lower in the uncovered stent group than in the covered stent group.     

Percutaneous Unilateral Biliary Metallic Stent Placement in Patients with Malignant Obstruction of the Biliary Hila and Contralateral Portal Vein Steno-Occlusion

Objective

To investigate the outcomes of percutaneous unilateral metallic stent placement in patients with a malignant obstruction of the biliary hila and a contralateral portal vein steno-occlusion.

Materials and Methods

Sixty patients with a malignant hilar obstruction and unilobar portal vein steno-occlusion caused by tumor invasion or preoperative portal vein embolization were enrolled in this retrospective study from October 2010 to October 2013. All patients were treated with percutaneous placement of a biliary metallic stent, including expanded polytetrafluoroethylene (ePTFE)-covered stents in 27 patients and uncovered stents in 33 patients.

Results

A total of 70 stents were successfully placed in 60 patients. Procedural-related minor complications, including self-limiting hemobilia (n = 2) and cholangitis (n = 4) occurred in six (10%) patients. Acute cholecystitis occurred in two patients. Successful internal drainage was achieved in 54 (90%) of the 60 patients. According to a Kaplan-Meier analysis, median survival time was 210 days (95% confidence interval [CI], 135-284 days), and median stent patency time was 133 days (95% CI, 94-171 days). No significant difference in stent patency was observed between covered and uncovered stents (p = 0.646). Stent dysfunction occurred in 16 (29.6%) of 54 patients after a mean of 159 days (range, 65-321 days).

Conclusion

Unilateral placement of ePTFE-covered and uncovered stents in the hepatic lobe with a patent portal vein is a safe and effective method for palliative treatment of patients with a contralateral portal vein steno-occlusion caused by an advanced hilar malignancy or portal vein embolization. No significant difference in stent patency was detected between covered and uncovered metallic stents.     

Retrievable covered nitinol stents: experiences in 108 patients with malignant esophageal strictures

PURPOSE: The authors report their experience with three types of retrievable covered nitinol stents in patients with malignant esophageal strictures. MATERIALS AND METHODS: Three types of retrievable covered nitinol stents were designed. Type A stents were placed in 45 patients, type B stents were placed in 29 patients, and type C stents were placed in 34 patients. The stents were removed with use of a stent retrieval set under fluoroscopic guidance when the stents caused complications. Stent patency, symptom relief, survival rate, and complications were analyzed relative to stent type and radiation therapy. RESULTS: The timing of radiation and the stent type have significant effects on occurrence of complications such as stent migration and fistula formation (P =.002 and P = 0.029, respectively). Complications were significantly more frequent in patients with the type B stent than those with type A or type C stents (P =.008). Patients who underwent radiation therapy before stent placement or who underwent no radiation therapy experienced substantially less complications than those who underwent radiation therapy after stent placement (P =.005 and P <.001, respectively). The survival period was significantly longer in patients who underwent radiation therapy after stent placement than in the other groups (P =.034). Stents were removed from 15 patients (14%) 2 days to 16 weeks (mean, 4 weeks) after stent placement as a result of severe pain (n = 7), stent migration (n = 6), or stent deformity (n = 2). Stent removal was well tolerated in all patients. CONCLUSION: Use of retrievable covered nitinol stents seems to be a safe and effective method of treatment in patients with malignant esophageal strictures. However, removal of the stents was needed in 14% of the patients because of complications. Patients who underwent radiation therapy after stent placement and those with the type B stent experienced more complications than other patients.     

Primary patency of femoropopliteal arteries treated with nitinol versus stainless steel self-expanding stents: propensity score-adjusted analysis

PURPOSE: To evaluate, in a propensity score-adjusted analysis, the intermediate-term primary patency rates associated with nitinol versus stainless steel self-expanding stent placement for treatment of atherosclerotic lesions in femoropopliteal arteries. MATERIALS AND METHODS: The authors analyzed the clinical and imaging data of 175 consecutive patients with peripheral artery disease and either intermittent claudication (n = 150) or critical limb ischemia (n = 25) who underwent femoropopliteal artery implantation of nitinol (n = 104) or stainless steel (n = 123) stents in a nonrandomized setting. The stents were placed owing to either significant residual stenosis (ie, >30% lumen diameter reduction) or flow-limiting dissection after initial balloon angioplasty of the femoropopliteal artery. Patients were followed up for a median period of 9 months (mean, 13 months; range, 6-66 months) for the detection of a first in-stent restenosis, defined as a greater than 50% lumen diameter reduction that was seen at color-coded duplex ultrasonography and confirmed at angiography. RESULTS: Cumulative patency rates at 6, 12, and 24 months were 85%, 75%, and 69%, respectively, after nitinol stent placement versus 78%, 54%, and 34%, respectively, after stainless steel stent placement (P =.008, log-rank test). There were no statistically significant differences in associated patency among the three different nitinol stents used (P =.72, log-rank test). Multivariate Cox proportional hazard analysis, in which the effect of propensity to receive a nitinol stent was considered, revealed a significantly reduced risk of restenosis with the nitinol stents compared with the risk of restenosis with the stainless steel stents (adjusted hazard ratio, 0.44; 95% confidence interval: 0.22, 0.85; P =.014). CONCLUSION: Nitinol stents are associated with significantly improved primary patency rates in femoropopliteal arteries compared with stainless steel stents. Randomized controlled trials are needed to confirm these results.     

How to design the optimal self-expandable oesophageal metallic stents: 22 years of experience in 645 patients with malignant strictures

Objectives

To evaluate the clinical efficacy and safety of self-expandable metallic stent (SEMS) placement for malignant oesophageal strictures and their relationship with stent designs.

Methods

Seven generations of SEMS were used to treat 645 consecutive patients with oesophageal strictures. Logistic regression models were constructed to identify predictive factors associated with complications.

Results

Stent placement was technically successful in 641 of 645 patients (99.4%). The clinical success rate was 95.5%. There were 260 (40.3%) complications after stent placement. Due to complications, 68 stents were removed; 66 of 68 stents (97.1%) were removed successfully. Stainless steel (SS) stents (odds ratio [OR] 4.18; 95% confidence interval [CI] 2.10, 8.32) and radiation therapy (RT) before stent placement (OR 4.23; CI 2.02, 8.83) were significantly associated with severe pain. Flared ends (OR 9.63; CI 3.38, 27.43), stricture length <6 cm (OR 2.01; CI 1.13, 3.60), and a stent diameter <18 mm (OR 3.00; CI 1.32, 6.84) were predictive factors of stent migration. Polyurethane membranes were associated with more frequent tumour ingrowth than polytetrafluoroethylene (PTFE) membranes (P?=?0.002).

Conclusions

Despite the relatively high complication rate, retrievable self-expandable PTFE-covered nitinol stents equipped with a head and a tail appeared to be an effective treatment for malignant oesophageal strictures.

Key Points

? Self-expandable metallic stents are now widely used for palliating unresectable oesophageal strictures ? Stents equipped with a head and a tail showed decreased stent migration rate ? Stainless steel stents and radiation therapy before stenting can cause severe pain ? Polyurethane membranes were associated with more frequent tumour ingrowth than polytetrafluoroethylene membranes ? Considering the high complication rate, stent retrievability is important for safety reasons