Covered versus uncovered self-expandable metal stents for malignant biliary strictures: A meta-analysis and systematic review.

PubMed

Moole, Harsha; Bechtold, Matthew L; Cashman, Micheal; Volmar, Fritz H; Dhillon, Sonu; Forcione, David; Taneja, Deepak; Puli, Srinivas R

2016-09-01

Self-expandable metal stents (SEMS) are used for palliating inoperable malignant biliary strictures. It is unclear if covered metal stents are superior to uncovered metal stents in these patients. We compared clinical outcomes in patients with covered and uncovered stents. Studies using covered and uncovered metallic stents for palliation in patients with malignant biliary stricture were reviewed. Articles were searched in MEDLINE, PubMed, and Ovid journals. Fixed and random effects models were used to calculate the pooled proportions. Initial search identified 1436 reference articles, of which 132 were selected and reviewed. Thirteen studies (n = 2239) for covered and uncovered metallic stents which met the inclusion criteria were included in this analysis. Odds ratio for stent occlusion rates in covered vs. uncovered stents was 0.79 (95 % CI = 0.65 to 0.96). Survival benefit in patients with covered vs. uncovered stents showed the odds ratio to be 1.29 (95 % CI = 0.95 to 1.74). Pooled odds ratio for migration of covered vs. uncovered stents was 9.9 (95 % CI = 4.5 to 22.3). Covered stents seemed to have significantly lesser occlusion rates, increased odds of migration, and increased odds of pancreatitis compared to uncovered stents. There was no statistically significant difference in the survival benefit, overall adverse event rate, and patency period of covered vs. uncovered metal stents in patients with malignant biliary strictures.

Temporary placement of retrievable fully covered metallic stents versus percutaneous balloon dilation in the treatment of benign biliary strictures.

PubMed

Kim, Jin Hyoung; Gwon, Dong Il; Ko, Gi-Young; Sung, Kyu-Bo; Lee, Sung Koo; Yoon, Hyun-Ki; Shin, Ji Hoon; Song, Ho-Young

2011-06-01

To compare retrospectively percutaneous transhepatic primary placement of a retrievable self-expanding metallic stent with percutaneous balloon dilation for the treatment of benign biliary strictures. From 2005-2009, 66 patients with benign biliary strictures in whom an endoscopic approach failed or in whom such an approach was inaccessible were evaluated. Of 66 patients, 31 underwent balloon dilation, and 35 underwent temporary metallic stent placement. The etiologies of the benign strictures were anastomotic stricture after surgery (n = 54), stricture secondary to intraoperative injury (n = 9), inflammatory stricture (n = 2), and stricture secondary to trauma (n = 1). The primary patency rates were significantly better in the stent group (87% at 3 years) than in the balloon group (44% at 3 years; P = .022). The indwelling period of percutaneous transhepatic biliary drainage (PTBD) catheters after the initial procedure was able to be significantly reduced in the stent group (median 2.5 months) compared with the balloon group (median 4.5 months; P = .001). Significant bleeding (associated with PTBD) occurred in one patient in the balloon group. In the stent group, stent migration occurred in two patients, and one patient underwent surgery for stent removal after failure of removal under fluoroscopic guidance. Percutaneous primary placement of a retrievable self-expanding metallic stent showed superior intermediate-term results compared with percutaneous balloon dilation for the treatment of benign biliary strictures. In addition, the indwelling period of PTBD catheters can be significantly reduced using temporary stent placement. Copyright © 2011 SIR. Published by Elsevier Inc. All rights reserved.

Comparison between uncovered and covered self-expandable metal stent placement in malignant duodenal obstruction.

PubMed

Kim, Ji Won; Jeong, Ji Bong; Lee, Kook Lae; Kim, Byeong Gwan; Ahn, Dong Won; Lee, Jae Kyung; Kim, Su Hwan

2015-02-07

To compare the clinical outcomes of uncovered and covered self-expandable metal stent placements in patients with malignant duodenal obstruction. A total of 67 patients were retrospectively enrolled from January 2003 to June 2013. All patients had symptomatic obstruction characterized by nausea, vomiting, reduced oral intake, and weight loss. The exclusion criteria included asymptomatic duodenal obstruction, perforation or peritonitis, concomitant small bowel obstruction, or duodenal obstruction caused by benign strictures. The technical and clinical success rate, complication rate, and stent patency were compared according to the placement of uncovered (n = 38) or covered (n = 29) stents. The technical and clinical success rates did not differ between the uncovered and covered stent groups (100% vs 96.6% and 89.5% vs 82.8%). There were no differences in the overall complication rates between the uncovered and covered stent groups (31.6% vs 41.4%). However, stent migration occurred more frequently with covered than uncovered stents [20.7% (6/29) vs 0% (0/38), P < 0.05]. Moreover, the overall cumulative median duration of stent patency was longer in uncovered than in covered stents [251 d (95%CI: 149.8 d-352.2 d) vs 139 d (95%CI: 45.5 d-232.5 d), P < 0.05 by log-rank test] The overall cumulative median survival period was not different between the uncovered stent (70 d) and covered stent groups (60 d). Uncovered stents may be preferable in malignant duodenal obstruction because of their greater resistance to stent migration and longer stent patency than covered stents.

Comparison between uncovered and covered self-expandable metal stent placement in malignant duodenal obstruction

PubMed Central

Kim, Ji Won; Jeong, Ji Bong; Lee, Kook Lae; Kim, Byeong Gwan; Ahn, Dong Won; Lee, Jae Kyung; Kim, Su Hwan

2015-01-01

AIM: To compare the clinical outcomes of uncovered and covered self-expandable metal stent placements in patients with malignant duodenal obstruction. METHODS: A total of 67 patients were retrospectively enrolled from January 2003 to June 2013. All patients had symptomatic obstruction characterized by nausea, vomiting, reduced oral intake, and weight loss. The exclusion criteria included asymptomatic duodenal obstruction, perforation or peritonitis, concomitant small bowel obstruction, or duodenal obstruction caused by benign strictures. The technical and clinical success rate, complication rate, and stent patency were compared according to the placement of uncovered (n = 38) or covered (n = 29) stents. RESULTS: The technical and clinical success rates did not differ between the uncovered and covered stent groups (100% vs 96.6% and 89.5% vs 82.8%). There were no differences in the overall complication rates between the uncovered and covered stent groups (31.6% vs 41.4%). However, stent migration occurred more frequently with covered than uncovered stents [20.7% (6/29) vs 0% (0/38), P < 0.05]. Moreover, the overall cumulative median duration of stent patency was longer in uncovered than in covered stents [251 d (95%CI: 149.8 d-352.2 d) vs 139 d (95%CI: 45.5 d-232.5 d), P < 0.05 by log-rank test] The overall cumulative median survival period was not different between the uncovered stent (70 d) and covered stent groups (60 d). CONCLUSION: Uncovered stents may be preferable in malignant duodenal obstruction because of their greater resistance to stent migration and longer stent patency than covered stents. PMID:25663777

Endovascular abdominal aortic stenosis treatment with the OptiMed self-expandable nitinol stent.

PubMed

Ghazi, Payam; Haji-Zeinali, Ali-Mohammad; Shafiee, Nahid; Qureshi, Shakeel A

2009-10-01

To evaluate the safety and feasibility of self-expandable stents (OptiMed) for treatment of abdominal aortic stenosis in the situations in which the aortic stenosis locates near the origin of celiac, superior mesenteric, renal and inferior mesenteric arteries. Five consecutive patients scheduled for endovascular treatment of abdominal aortic stenosis by self-expandable nitinol stent (Sinus-Aorta/OptiMed) implantation. The diameter of the stent was chosen as 10-30% more than that of the normal portion of the aorta above the stenosis. Long stents of 60 mm or longer were chosen. After stent deployment, balloon postdilation was performed with a balloon in patients with residual gradient > 5 mm Hg. All patients were successfully treated with the OptiMed stents. The balloon predilation was performed in one patient due to severe stenosis. The mean diameter and length of the stents deployed were 20.4 +/- 2.9 (range, 16-24 mm) and 64 +/- 8.9 (range, 60-80 mm), respectively. The balloon postdilation was performed in all cases. The mean diameter of the balloons was 13.6 +/- 1.5 (range, 12-15 mm). The mean diameter of stenosis increased from 4.8 +/- 1.9 to 14.4 +/- 1.8 mm after stent placement. The mean peak systolic gradient decreased from 46.8 +/- 31.5 mm Hg to 0.8 +/- 1.8 mm Hg. During follow-up (22.8 +/- 14.3 months), none of the patients had restenosis within the stent, occlusion of any branches of the aorta, or other related complications. In our small series, we observed that abdominal aortic stenosis can be successfully and effectively treated with OptiMed stents in the situations in which the stenotic segment is located next to the origins of the main visceral branches of abdominal aorta.

Self-expandable metal stents in the treatment of benign anastomotic stricture after rectal resection for cancer.

PubMed

Lamazza, A; Fiori, E; Sterpetti, A V; Schillaci, A; Scoglio, D; Lezoche, E

2014-04-01

To evaluate the use of self-expandable metallic stents to treat patients with symptomatic benign anastomotic stricture after colorectal resection. Ten patients with a benign symptomatic anastomotic stricture after colorectal resection were treated with endoscopic placement of a self-expandable metal stent. The stent was placed successfully in all 10 patients without any major morbidity. At a mean follow-up of 18 months the stenosis was resolved successfully in 7 out 10 patients (70%). The remaining three patients were subsequently treated successfully with balloon dilatation. Self-expandable metal stents represent a valid alternative to balloon dilatation to treat patients with benign symptomatic anastomotic stricture after colorectal resection for cancer. Colorectal Disease © 2013 The Association of Coloproctology of Great Britain and Ireland.

Fabrication of balloon-expandable self-lock drug-eluting polycaprolactone stents using micro-injection molding and spray coating techniques.

PubMed

Liu, Shih-Jung; Chiang, Fu-Jun; Hsiao, Chao-Ying; Kau, Yi-Chuan; Liu, Kuo-Sheng

2010-10-01

The purpose of this report was to develop novel balloon-expandable self-lock drug-eluting poly(ε-caprolactone) stents. To fabricate the biodegradable stents, polycaprolactone (PCL) components were first fabricated by a lab-scale micro-injection molded machine. They were then assembled and hot-spot welded into mesh-like stents of 3 and 5 mm in diameters. A special geometry of the components was designed to self-lock the assembled stents and to resist the external pressure of the blood vessels after being expanded by balloons. Characterization of the biodegradable PCL stents was carried out. PCL stents exhibited comparable mechanical property to that of metallic stents. No significant collapse pressure reduction and weight loss of the stents were observed after being submerged in PBS for 12 weeks. In addition, the developed stent was coated with paclitaxel by a spray coating technique and the release characteristic of the drug was determined by an in vitro elution method. The high-performance liquid chromatography analysis showed that the biodegradable stents could release a high concentration of paclitaxel for more than 60 days. By adopting the novel techniques, we will be able to fabricate biodegradable drug-eluting PCL stents of different sizes for various cardiovascular applications.

Feasibility and safety of placement of a newly designed, fully covered self-expandable metal stent for refractory benign pancreatic ductal strictures: a pilot study (with video).

PubMed

Park, Do Hyun; Kim, Myung-Hwan; Moon, Sung-Hoon; Lee, Sang Soo; Seo, Dong-Wan; Lee, Sung-Koo

2008-12-01

Painful chronic pancreatitis with main pancreatic ductal strictures is usually managed with endotherapy with a plastic stent. To date, the role of placement of metallic stents, especially uncovered ones in benign pancreatic ductal stricture, has been unsatisfactory as a result of stent dysfunction related to mucosal hyperplasia. We explored the feasibility and safety of temporary placement of a newly designed, fully covered self-expandable metal stent (FCSEMS) in painful chronic pancreatitis and refractory benign pancreatic ductal strictures. A prospective pilot and feasibility study. A tertiary academic center. Thirteen patients with chronic painful pancreatitis of alcoholic (8) or idiopathic (5) etiology. ERCP with temporary FCSEMS placement (2 months). Endoscopic removal of FCSEMSs was performed with a snare or rat-tooth forceps. End points were feasibility, safety, and morbidity. Successful FCSEMS placement was performed in all enrolled patients. After immediate placement of FCSEMS, 2 patients had mild acute pancreatitis related mainly to the stricture dilation procedure (Soehendra stent retriever or balloon dilation). Complications associated with stent placement included 5 migrations (39%, 1 proximal and 4 distal) and 2 incidents of cholestatic liver dysfunction associated with the compression of the bile duct orifice by expansion of FCSEMSs. In 1 patient with proximal migration, the stent was repositioned by an inflated retrieval balloon. Additional endoscopic biliary sphincterotomy with or without biliary stenting was performed in 2 patients with cholestatic liver dysfunction. There was no occurrence of pancreatic sepsis among any patients. FCSEMSs were removed from 9 of 9 patients without stent migration (100% [9/9] as per protocol, and 69% [9/13] as intention to treat, respectively). Improvement or resolution of the pancreatic ductal strictures was confirmed in all 13 patients on follow-up ERCP (2 months after stent placement), regardless of stent migration. Small patient populations without long-term follow-up. Two-month placement of FCSEMSs in patients with refractory benign pancreatic ductal strictures may be feasible and relatively safe. However, stent migration was not uncommon. A further investigation with ideal stent design may therefore be needed before recommending FCSEMSs as a therapeutic option for refractory benign pancreatic ductal strictures.

A rapid-exchange monorail stent system for salvage of failing femoropopliteal bypass grafts.

PubMed

Jahnke, Thomas; Brossmann, Joachim; Walluscheck, Knut; Heller, Martin; Müller-Hülsbeck, Stefan

2003-08-01

To analyze the safety and effectiveness of a new monorail stent system for the treatment of failing femoropopliteal bypass grafts. Acute distal occlusions or stenoses of femoropopliteal bypass grafts were treated with balloon-expandable stents (13 or 18-mm diameter) pre-mounted on a monorail balloon catheter system. The delivery system was assessed subjectively for (1). compatibility with the sheath, (2). lesion crossing potential, (3). radiopacity, (4). flexibility of the catheter, (5). adequacy of stent expansion, and (5). balloon refolding. In 8 failing bypass grafts with distal lesions, the delivery system successfully deployed the stent at the desired location. Sheath compatibility, catheter flexibility, lesion crossing, and stent expansion were rated "excellent" by all examiners for the 18-mm device. Radiopacity of the mounted stent was graded "good" before and during positioning, but only "sufficient" following expansion. For this type of lesion, the investigators rated the overall performance of the device superior to conventional "over-the-wire" systems. The monorail balloon-expandable stent delivery system provides rapid introduction of the device over the guidewire, and its low profile facilitates the use of small sheaths to minimize access-site complications.

Stent design favorably influences the vascular response in normal porcine coronary arteries.

PubMed

Carter, A J; Scott, D; Rahdert, D; Bailey, L; De Vries J; Ayerdi, K; Turnlund, T; Jones, R; Virmani, R; Fischell, T A

1999-03-01

The purpose of this study was to compare the arterial response following implantation of a stainless-steel, balloon-expandable, tubular slotted stent with that of a novel computer-designed, multi-cellular stent in normal porcine coronary arteries. Intracoronary stent placement has evolved into the primary strategy for percutaneous revascularization of symptomatic coronary arterial lesions. Presently there is intense interest in developing new stent designs to improve stent delivery and biocompatability. Computer-assisted design was utilized to develop a balloon-expandable stent with symmetric expansion properties, uniform arterial wall coverage, longitudinal flexibility and radial strength. Quantitative coronary angiography and histological assessment of the stented arteries was used to evaluate the acute and chronic vascular responses to a stainless-steel, balloon-expandable, tubular slotted stent as compared to the computer-designed BX stent in the normolipemic swine. Forty stents (24 BX, 16 tubular slotted) were implanted in 19 miniature swine at a mean inflation pressure of 9 atm using identical delivery systems. Eight of the BX and none of the tubular slotted stents were post-dilated with a non-compliant balloon at 12-14 atm. The mean stent-to-artery ratio was similar for the BX (1.03 +/- 0.06) and tubular slotted (1.04 +/- 0.11; p = 0.59) designs. Protrusion or asymmetric radial flaring of a strut at the stent margin was present in 1 of 23 BX stents (4.3%) and 10 of 15 tubular slotted stents (66.7%; p < 0.0001). The mean arterial injury score was significantly less for the BX stent (0.2 +/- 0.2) as compared with the tubular slotted stents (0.4 +/- 0.4; p = 0.025). At 3 days, thrombus area was similar for the BX and tubular slotted designs (0.42 +/- 0.16 mm2 versus 0.44 +/- 0.18 mm2, respectively; p = 0.88). The mean neointimal area was significantly less for the BX at 2 months (1.09 +/- 0.25 mm2 versus 2.93 +/- 2.26 mm2 in the tubular slotted stent) and at 6 months (1.10 +/- 0.26 mm2 versus 2.07 +/- 0.65 mm2 in the tubular slotted stent; p = 0.01), resulting in approximately 50% less in-stent stenosis. The arterial response to a balloon-expandable stent can be favorably influenced by computer-assisted modification of design in an experimental model. Further study is warranted to determine the impact of stent design upon clinical in-stent restenosis.

Comparison of covered versus uncovered wire mesh stents in the canine biliary tract.

PubMed

Silvis, S E; Sievert, C E; Vennes, J A; Abeyta, B K; Brennecke, L H

1994-01-01

Self-expanding wire mesh stents have been developed for endoscopic placement across malignant biliary strictures, but tumor ingrowth may limit the usefulness of open mesh stents. We reasoned that coating the wire mesh might prevent tumor ingrowth. Tissue response to covered and uncovered stents was compared in dogs. Stents were surgically placed in the bile ducts of 22 mongrel dogs through the sphincter of Oddi. Either a silicone-covered stent or an uncovered stent was inserted. Liver function test values remained normal throughout a 1- or 3-month study. Necropsy revealed that all ducts were unobstructed. Bile duct histologic examination revealed mild-to-moderate cellular infiltration in all animals. Mucosal hyperplasia was more marked in the animals with uncovered stents and the bare wires became deeply embedded in bile duct epithelium, whereas the wires of covered stents did not. We conclude that covered stents are well tolerated by the canine bile duct. These results suggest that such stents may be removable, making self-expanding metal stents an appropriate treatment for both benign and malignant biliary strictures.

Management of stent dislodgment in coarctoplasty of aorta with three overlapping self-expandable nitinol stents.

PubMed

Ghazi, Payam; Haji-Zeinali, Ali-Mohammad

2010-01-01

We describe a case of native coarctation of aorta managed with three self-expandable nitinol stents. After balloon pre-dilation, the first and second stents were dislodged. The coarcted area was successfully treated with the third stent overlapped with the previous stents. During follow up (30 months), the patient was free of complications. It seems that implantation of multiple overlapping self-expandable stents in aortic coarctation patients, if needed, is safe and possible.

Orbital atherectomy as an adjunct to debulk difficult calcified lesions prior to mesenteric artery stenting.

PubMed

Manunga, Jesse M; Oderich, Gustavo S

2012-08-01

To describe a technique in which percutaneous orbital atherectomy is used to debulk heavily calcified superior mesenteric artery (SMA) occlusions as an adjunct in patients undergoing angioplasty and stenting. The technique is demonstrated in a 62-year-old woman with a replaced right hepatic artery originating from an SMA occluded by densely calcified lesions. Via a left transbrachial approach, a 7-F MPA guide catheter was used to engage the ostium of the SMA, which was crossed using a catheter and guidewire. The calcified lesion was debulked using the 2-mm Diamondback 360° orbital atherectomy system. The wire was exchanged for a 0.014-inch filter wire and 0.018-inch guidewire. Using a 2-guidewire technique, the SMA was stented with a self-expanding stent for the distal lesion that crossed side branches and a balloon-expandable stent at the ostium. A 0.014-inch guidewire was placed into the replaced hepatic artery through a cell of the self-expanding stent, followed by deployment of a small balloon-expandable stent to address the residual lesion. The use of orbital atherectomy to debulk occluded and heavily calcified SMA lesions may optimize the technical results with angioplasty and stenting.

Efficacy of stent angioplasty for symptomatic stenoses of the proximal vertebral artery.

PubMed

Weber, W; Mayer, T E; Henkes, H; Kis, B; Hamann, G F; Holtmannspoetter, M; Brueckmann, H; Kuehne, D

2005-11-01

To evaluate the safety and efficacy of stent angioplasty in the treatment of symptomatic arteriosclerotic stenoses of the proximal vertebral artery (VA). Thirty-eight symptomatic stenoses of the vertebral origin were treated with flexible balloon-expandable coronary stents. Angiographic and clinical follow-up examinations were obtained in 26 patients at a mean of 11 months. The immediate post-procedural angiographic results showed no residual stenosis in 33 vessels and mild residual stenoses in five vessels. Periprocedurally, there were two asymptomatic technical complications and one TIA. During follow-up re-stenosis could be detected in 10 cases (36%), and vessel occlusions in two patients. Two stents were broken. One of the restenosis caused a TIA within the follow-up period. Flexible balloon-expandable coronary stents proved to be save and effective in preventing vertebrobasilar stroke but were incapable to preserve the proximal vertebral artery lumen. For the VA origine an adequate stent, self-expanding, bioresorbable, or drug-eluting has to be found.

Transjugular Intrahepatic Portosystemic Shunt Flow Reduction with Adjustable Polytetrafluoroethylene-Covered Balloon-Expandable Stents Using the “Sheath Control” Technique

DOE Office of Scientific and Technical Information (OSTI.GOV)

Blue, Robert C., E-mail: Robert.c.blue@gmail.com; Lo, Grace C.; Kim, Edward

PurposeA complication of transjugular intrahepatic portosystemic shunts (TIPS) placement is refractory portosystemic encephalopathy (PSE) often requiring TIPS reduction. We report the results of a “sheath control technique” utilizing constraining sheaths during deployment of polytetrafluoroethylene (PTFE)-covered balloon-expandable stents, minimizing stent migration, and providing additional procedural control.MethodsTIPS reduction was performed in 10 consecutive patients for PSE using Atrium iCast covered stents (Atrium Maquet Getinge Group, Germany). Within the indwelling TIPS stent, a 9 mm × 59 mm iCast stent was deployed with 2 cm exposed from the sheath’s distal end and the majority of the stent within the sheath to create the distal hourglass shape. During balloonmore » retraction, the stent was buttressed by the sheath. The proximal portion of the stent was angioplastied to complete the hourglass configuration, and the central portion of the stent was dilated to 5 mm. Demographics, pre- and post-procedure laboratory values, and outcomes were recorded.ResultsTen patients underwent TIPS reduction with 100 % technical success. There was no stent migration during stent deployment. All patients experienced initial improvement of encephalopathy. One patient ultimately required complete TIPS occlusion for refractory PSE, and another developed TIPS occlusion 36 days post-procedure. There was no significant trend toward change in patients’ MELD scores immediately post-procedure or at 30 days (p = 0.46, p = 0.47, respectively).ConclusionTIPS reduction using Atrium iCast PTFE balloon-expandable stents using the “sheath control technique” is safe and effective, and minimizes the risk of stent migration.« less

[Stent implantation in the treatment of pharynx anastomotic stenosis after cervical esophageal resection: a case report].

PubMed

Zang, Chuanshan; Sun, Jian; Sun, Yan

2016-03-01

We report the treatment of one patient with pharynx anastomotic stenosis after cervical esophagealresection by stent implantation. The patient suffered from serious pharynx anastomotic stenosis after gastric-pha-ryngeal anastomosis. After balloon-dilatation,a domestic self-expanding Z-stents was implanted in the stricture ofthe esophagus under the X-rays. After stent implantation, the patient has been leading a normal life for threeyears. Balloon dilatation and stent implantation is an effective and safe method in the treatment of patients withpharynx anastomotic stenosis.

Endovascular revascularization for aortoiliac atherosclerotic disease

PubMed Central

Aggarwal, Vikas; Waldo, Stephen W; Armstrong, Ehrin J

2016-01-01

Atherosclerotic iliac artery disease is increasingly being treated with endovascular techniques. A number of new stent technologies can be utilized with high long-term patency, including self-expanding stents, balloon-expandable stents, and covered stents, but comparative data on these stent types and in more complex lesions are lacking. This article provides a review of currently available iliac stent technologies, as well as complex procedural aspects of iliac artery interventions, including approaches to the treatment of iliac bifurcation disease, long segment occlusions, choice of stent type, and treatment of iliac artery in-stent restenosis. PMID:27099509

Partially covered versus uncovered self-expandable nitinol stents with anti-migration properties for the palliation of malignant distal biliary obstruction: A randomized controlled trial.

PubMed

Yang, Min Jae; Kim, Jin Hong; Yoo, Byung Moo; Hwang, Jae Chul; Yoo, Jun Hwan; Lee, Ki Seong; Kang, Joon Koo; Kim, Soon Sun; Lim, Sun Gyo; Shin, Sung Jae; Cheong, Jae Youn; Lee, Kee Myung; Lee, Kwang Jae; Cho, Sung Won

2015-01-01

Covered self-expandable metal stents (SEMSs) are increasingly used as alternatives to uncovered SEMSs for the palliation of inoperable malignant distal biliary obstruction to counteract tumor ingrowth. We aimed to compare the outcomes of partially covered and uncovered SEMSs with identical mesh structures and anti-migration properties, such as low axial force and flared ends. One hundred and three patients who were diagnosed with inoperable malignant distal biliary obstruction between January 2006 and August 2013 were randomly assigned to either the partially covered (n = 51) or uncovered (n = 52) SEMS group. There were no significant differences in the cumulative stent patency, overall patient survival, stent dysfunction-free survival and overall adverse events, including pancreatitis and cholecystitis, between the two groups. Compared to the uncovered group, stent migration (5.9% vs. 0%, p = 0.118) and tumor overgrowth (7.8% vs. 1.9%, p = 0.205) were non-significantly more frequent in the partially covered group, whereas tumor ingrowth showed a significantly higher incidence in the uncovered group (5.9% vs. 19.2%, p = 0.041). Stent migration in the partially covered group occurred only in patients with short stenosis of the utmost distal bile duct (two in ampullary cancer, one in bile duct cancer), and did not occur in any patients with pancreatic cancer. For the palliation of malignant distal biliary obstruction, endoscopic placement of partially covered SEMSs with anti-migration designs and identical mesh structures to uncovered SEMSs failed to prolong cumulative stent patency or reduce stent migration.

Immediate and late clinical and angiographic outcomes after GFX coronary stenting: is high-pressure balloon dilatation necessary?

PubMed

Park, S W; Hong, M K; Lee, C W; Kim, J J; Park, H K; Cho, G Y; Kang, D H; Song, J K; Park, S J

2000-08-01

The GFX stent is a balloon-expandable stent made of sinusoidal element of stainless steel. The adjunct high-pressure balloon dilatations were usually recommended in routine stenting procedure. The aim of this study was to evaluate the immediate and long-term clinical and angiographic outcomes and to investigate the necessity of high-pressure balloon dilatation during GFX stenting. In all, 172 consecutive patients underwent single 12 or 18 mm GFX stent implantation in 188 native coronary lesions. Two types of stenting technique were used: (1) stent size of a final stent-to-artery ratio of 1:1 (inflation pressure > 10 atm, high-pressure group), and (2) stent size of 0.5 mm bigger than reference vessel (inflation pressure < or = 10 atm, low-pressure group). The adjunct high-pressure balloon dilatations were performed only in cases of suboptimal results. The adjunct high-pressure balloon dilatation was required in 11 of 83 lesions (13%) in the high-pressure group and in 7 of 105 lesions (7%) in the low-pressure group (p = 0.203). Procedural success rate was 100%. There were no significant differences of in-hospital and long-term clinical events between the two groups. The overall angiographic restenosis rate was 17.7%; 18.4% in the high-pressure group and 17.1% in the low-pressure group (p = 0.991). The GFX stent is a safe and effective device with a high procedural success rate and favorable late clinical outcome for treatment of native coronary artery disease. Further randomized trials may be needed to compare stenting techniques in GFX stent implantation.

Malignant Gastroduodenal Obstruction: Treatment with Self-Expanding Uncovered Wallstent

DOE Office of Scientific and Technical Information (OSTI.GOV)

Gutzeit, Andreas, E-mail: Andreas.Gutzeit@ksw.ch; Binkert, Christoph A.; Schoch, Eric

2009-01-15

Purpose: To retrospectively evaluate the clinical effectiveness of a self-expanding uncovered Wallstent in patients with malignant gastroduodenal obstruction. Materials and Methods: Under combined endoscopic and fluoroscopic guidance, 29 patients with a malignant gastroduodenal stenosis were treated with a self-expanding uncovered metallic Wallstent. A dysphagia score was assessed before and after the intervention to measure the success of this palliative therapy. The dysphagia score ranged between grade 0 to grade 4: grade 0 = able to tolerate solid food, grade 1 = able to tolerate soft food, grade 2 = able to tolerate thick liquids, grade 3 = able to toleratemore » water or clear fluids, and grade 4 = unable to tolerate anything perorally. Stent patency and patients survival rates were calculated. Results: The insertion of the gastroduodenal stent was technically successful in 28 patients (96.5%). After stenting, 25 patients (86.2%) showed clinical improvement by at least one score point. During follow-up, 22 (78.5%) of 28 patients showed no stent occlusion until death and did not have to undergo any further intervention. In six patients (20.6%), all of whom were treated with secondary stent insertions, occlusion with tumor ingrowth and/or overgrowth was observed after the intervention. The median period of primary stent patency in our study was 240 days. Conclusion: Placement of an uncovered Wallstent is clinically effective in patients with malignant gastroduodenal obstruction. Stent placement is associated with high technical success, good palliation effect, and high durability of stent function.« less

Treatment of benign and malignant tracheobronchial obstruction with metal wire stents: experience with a balloon-expandable and a self-expandable stent type.

PubMed

Rieger, Johannes; Hautmann, Hubert; Linsenmaier, Ulrich; Weber, Cristoph; Treitl, Markus; Huber, Rudolf Maria; Pfeifer, Klaus-Jürgen

2004-01-01

Over the last few years various types of metal wire stents have been increasingly employed in the treatment of both malignant and benign tracheobronchial obstruction. To date, however, few studies have investigated the in vivo properties of different stent types. We implanted 26 balloon-expandable tantalum Strecker stents (18 patients) and 18 self-expandable Wallstents (16 patients) into the tracheobronchial system of 30 patients with combined stenting in 4 patients. Mean age was 51 years (range: 0.5-79 years). Malignant disease was present in 23 patients, benign disease in seven patients. Both patients and individual stents were monitored clinically and radiographically. The probability of stents remaining within the tracheobronchial system, and of their remaining undislocated and uncompressed was calculated using Kaplan-Meier analysis for both stent types. Average stent follow-up time was 112 days until explantation and 115 days until patients' death or discharge. Kaplan-Meier analysis revealed a higher probability for the Wallstent to remain within the tracheobronchial system. Dislocation and compression occurred more rarely. Explantation, however, if desired, was more difficult compared to the Strecker stent. The Wallstent also led to the formation of granulation tissue, especially at the proximal stent end, frequently requiring reintervention. Both stent types proved to be effective therapeutic options in the management of obstructive tracheobronchial disease. The mechanical properties of the Strecker stent seem to be less favorable compared to the Wallstent but removal is easy. For benign disease, however, the Wallstent reveals limitations due to significant side effects.

Successful technical and clinical outcome using a second generation balloon expandable coronary stent for transplant renal artery stenosis: Our experience.

PubMed

Salsamendi, Jason; Pereira, Keith; Baker, Reginald; Bhatia, Shivank S; Narayanan, Govindarajan

2015-10-01

Transplant renal artery stenosis (TRAS) is a vascular complication frequently seen because of increase in the number of renal transplantations. Early diagnosis and management is essential to optimize a proper graft function. Currently, the endovascular treatment of TRAS using angioplasty and/or stenting is considered the treatment of choice with the advantage that it does not preclude subsequent surgical correction. Treatment of TRAS with the use of stents, particularly in tortuous transplant renal anatomy presents a unique challenge to an interventional radiologist. In this study, we present three cases from our practice highlighting the use of a balloon-expandable Multi-Link RX Ultra coronary stent system (Abbott Laboratories, Abbott Park, Illinois, USA) for treating high grade focal stenosis along very tortuous renal arterial segments. Cobalt-Chromium alloy stent scaffold provides excellent radial force, whereas the flexible stent design conforms to the vessel course allowing for optimal stent alignment.

Partially Covered Metal Stents May Not Prolong Stent Patency Compared to Uncovered Stents in Unresectable Malignant Distal Biliary Obstruction.

PubMed

Kim, Jae Yun; Ko, Gyu Bong; Lee, Tae Hoon; Park, Sang-Heum; Lee, Yun Nah; Cho, Young Sin; Jung, Yunho; Chung, Il-Kwun; Choi, Hyun Jong; Cha, Sang-Woo; Moon, Jong Ho; Cho, Young Deok; Kim, Sun-Joo

2017-05-15

Controversy still exists regarding the benefits of covered self-expandable metal stents (SEMSs) compared to uncovered SEMSs. We aimed to compare the patency and stent-related adverse events of partially covered SEMSs (PC-SEMSs) and uncovered SEMSs in unresectable malignant distal biliary obstruction. A total of 134 patients who received a PC-SEMS or uncovered SEMS for palliation of unresectable malignant distal biliary obstruction were reviewed retrospectively. The main outcome measures were stent patency, stent-related adverse events, and overall survival. The median stent patency was 118 days (range, 3 to 802 days) with PC-SEMSs and 105 days (range, 2 to 485 days) with uncovered SEMSs (p=0.718). The overall endoscopic revision rate due to stent dysfunction was 36.6% (26/71) with PC-SEMSs and 36.5% (23/63) with uncovered SEMSs (p=0.589). Tumor ingrowth was more frequent with uncovered SEMSs (4.2% vs 19.1%, p=0.013), but migration was more frequent with PC-SEMSs (11.2% vs 1.5%, p=0.04). The incidence of stent-related adverse events was 2.8% (2/71) with PC-SEMSs and 9.5% (6/63) with uncovered SEMSs (p=0.224). The median overall survival was 166 days with PC-SEMSs and 168 days with uncovered SEMSs (p=0.189). Compared to uncovered SEMSs, PC-SEMSs did not prolong stent patency in unresectable malignant distal biliary obstruction. Stent migration was more frequent with PC-SEMSs. However, tumor ingrowth was less frequent with PC-SEMSs compared to uncovered SEMSs.

Partially Covered Metal Stents May Not Prolong Stent Patency Compared to Uncovered Stents in Unresectable Malignant Distal Biliary Obstruction

PubMed Central

Kim, Jae Yun; Ko, Gyu Bong; Lee, Tae Hoon; Park, Sang-Heum; Lee, Yun Nah; Cho, Young Sin; Jung, Yunho; Chung, Il-Kwun; Choi, Hyun Jong; Cha, Sang-Woo; Moon, Jong Ho; Cho, Young Deok; Kim, Sun-Joo

2017-01-01

Background/Aims Controversy still exists regarding the benefits of covered self-expandable metal stents (SEMSs) compared to uncovered SEMSs. We aimed to compare the patency and stent-related adverse events of partially covered SEMSs (PC-SEMSs) and uncovered SEMSs in unresectable malignant distal biliary obstruction. Methods A total of 134 patients who received a PC-SEMS or uncovered SEMS for palliation of unresectable malignant distal biliary obstruction were reviewed retrospectively. The main outcome measures were stent patency, stent-related adverse events, and overall survival. Results The median stent patency was 118 days (range, 3 to 802 days) with PC-SEMSs and 105 days (range, 2 to 485 days) with uncovered SEMSs (p=0.718). The overall endoscopic revision rate due to stent dysfunction was 36.6% (26/71) with PC-SEMSs and 36.5% (23/63) with uncovered SEMSs (p=0.589). Tumor ingrowth was more frequent with uncovered SEMSs (4.2% vs 19.1%, p=0.013), but migration was more frequent with PC-SEMSs (11.2% vs 1.5%, p=0.04). The incidence of stent-related adverse events was 2.8% (2/71) with PC-SEMSs and 9.5% (6/63) with uncovered SEMSs (p=0.224). The median overall survival was 166 days with PC-SEMSs and 168 days with uncovered SEMSs (p=0.189). Conclusions Compared to uncovered SEMSs, PC-SEMSs did not prolong stent patency in unresectable malignant distal biliary obstruction. Stent migration was more frequent with PC-SEMSs. However, tumor ingrowth was less frequent with PC-SEMSs compared to uncovered SEMSs. PMID:28208003

Temporary placement of stent grafts in postsurgical benign biliary strictures: a single center experience.

PubMed

Vellody, Ranjith; Willatt, Jonathon M; Arabi, Mohammad; Cwikiel, Wojciech B

2011-01-01

To evaluate the effect of temporary stent graft placement in the treatment of benign anastomotic biliary strictures. Nine patients, five women and four men, 22-64 years old (mean, 47.5 years), with chronic benign biliary anastomotic strictures, refractory to repeated balloon dilations, were treated by prolonged, temporary placement of stent-grafts. Four patients had strictures following a liver transplantation; three of them in bilio-enteric anastomoses and one in a choledocho-choledochostomy. Four of the other five patients had strictures at bilio-enteric anastomoses, which developed after complications following laparoscopic cholecystectomies and in one after a Whipple procedure for duodenal carcinoma. In eight patients, balloon-expandable stent-grafts were placed and one patient was treated by insertion of a self-expanding stent-graft. In the transplant group, treatment of patients with bilio-enteric anastomoses was unsuccessful (mean stent duration, 30 days). The patient treated for stenosis in the choledocho-choledochostomy responded well to consecutive self-expanding stent-graft placement (total placement duration, 112 days). All patients with bilio-enteric anastomoses in the non-transplant group were treated successfully with stent-grafts (mean placement duration, 37 days). Treatment of benign biliary strictures with temporary placement of stent-grafts has a positive effect, but is less successful in patients with strictures developed following a liver transplant.

Transapical Aortic Valve Replacement under Real-time Magnetic Resonance Imaging Guidance: Experimental Results with Balloon-Expandable and Self-Expanding Stents

PubMed Central

Horvath, Keith A.; Mazilu, Dumitru; Kocaturk, Ozgur; Li, Ming

2010-01-01

Objective Aortic valves have been implanted on self-expanding (SE) and balloon-expandable (BE) stents minimally invasively. We have demonstrated the advantages of transapical aortic valve implantation (tAVI) under real-time magnetic resonance imaging (rtMRI) guidance. Whether there are different advantages to SE or BE stents is unknown. We report rtMRI guided tAVI in a porcine model using both SE and BE stents, and compare the differences between the stents. Methods Twenty-two Yucatan pigs (45-57kgs.) underwent tAVI. Commercially available stentless bioprostheses (21-25mm) were mounted on either BE platinum-iridium stents or SE nitinol stents. rtMRI guidance was employed as the intraoperative imaging. Markers on both types of stents were used to enhance the visualization in rtMRI. Pigs were allowed to survive and had follow-up MRI scans and echocardiography at 1, 3 and 6 months postoperatively. Results rtMRI provided excellent visualization of the aortic valve implantation mounted on both stent types. The implantation times were shorter with the SE stents (60±14 seconds) than BE (74±18s), (p=0.027). Total procedure time was 31 and 37 minutes respectively (p=0.12). It was considerably easier to manipulate the SE stent during deployment without hemodynamic compromise. This was not always the case with the BE stent and its placement occasionally resulted in coronary obstruction and death. Long-term results demonstrated stability of the implants with preservation of myocardial perfusion and function over time for both stents. Conclusions SE stents were easier to position and deploy thus leading to fewer complications during tAVI. Future optimization of SE stent design should improve clinical results. PMID:20971017

Midterm to long-term safety and efficacy of self-expandable nitinol stent implantation for coarctation of aorta in adults.

PubMed

Haji Zeinali, Ali Mohammad; Sadeghian, Mohammad; Qureshi, Shakeel A; Ghazi, Payam

2017-09-01

Endovascular treatment of coarctation of aorta (CoA) by self-expandable Nitinol stents is one of the recognized treatment methods and may be an alternative to surgery or balloon-expandable stent implantation for CoA but there is little information about midterm to long term results of self-expandable stents. Sixty-two patients with CoA (40 men), with a mean age of 30.7 ± 11 years, (range 17-63 years) underwent stent implantation with Optimed self-expandable Nitinol stents between 2005 and 2014. Successful outcome was defined as peak systolic pressure gradient ≤20 mmHg after stent implantation. The patients were followed-up clinically and by echocardiography and in patients, in whom there was suspicion of recoarctation, CT angiography or recatheterization was performed. 65 stents were successfully implanted in all 62 patients. Peak systolic pressure gradient decreased from mean 62.4 ± 18 mmHg (range 35-100 mmHg) to mean 2.8 ± 5 mmHg (range 0-15 mmHg; P < 0.001). Stent displacement occurred in 3 patients during the procedure. These were managed successfully by an overlapping second stent. None of the patients had major complications such as aortic dissection, rupture, or vascular access problems. In follow up, only three patients had recoarctation, and two of these were managed successfully by balloon redilation or further stenting 16 and 18 months after the first procedure and one patient refused reintervention. There were two deaths, unrelated to the procedure, 12 and 78 months after the initial intervention. Follow-up of a mean of 45.5 ± 17 months (range 12-105 months) demonstrated no evidence of aneurysm formation or stent fracture. Self-expandable nitinol stents for the treatment of native and recurrent CoA is safe and has good efficacy with acceptable midterm to long-term outcome. © 2017 Wiley Periodicals, Inc.

Long term impact of balloon post-dilatation on neointimal formation: an experimental comparative study between second-generation self-expanding versus balloon-expandable stent technologies.

PubMed

Aboodi, Michael S; Milewski, Krzysztof; Tellez, Armando; Cheng, Yanping; Yi, Geng-Hua; Kaluza, Greg L; Granada, Juan F

2014-02-15

Background: Self-expanding stents (SES) are reemerging as therapeutic alternatives to treat coronary artery disease. It has been proposed that SES can improve clinical outcomes by inducing less injury at implantation and achieving better vessel wall apposition.To date, little data exists comparing the vascular response to both methods of deployment in a controlled experimental setting. Objective: To quantify differences in vascular injury and healing between second-generation SES and balloon-expandable stents (BES) and the effects of balloon post-dilatation in a porcine coronary model. Methods: Seventy-five bare SES (AXXESS or vProtect) and 42 BES (Vision) were implanted in porcine coronaries. A subset of these received balloon post-dilatation(SES 1 D 5 22, BES 1 D 5 20). Follow-up was scheduled at 30 (BES 5 10, BES 1 D 56, SES 5 19, SES 1 D 5 8), 90 (BES 5 6, BES 1 D 5 8, SES 5 19, SES 1 D 5 8), and 180 days (BES 5 6, BES 1 D 5 6, SES 5 15, SES 1 D 5 6). Results: In vivo imaging and histological analysis showed that neointimal formation peaks early (30 days) in BES. Conversely, for SES, the peak occurred later (90 days). However, the neointimal formation achieved in either group equalized at 180 days. For SES, post-dilatation shortened the peak of neointimal formation to 30 days. Conversely, for BES, post-dilatation delayed the peak of neointimal formation to 90 days. At 30 days, histology showed that SES had significantly less injury. However, at 90 days, injury scores tended to be higher for SES. By 180 days, injury scores were comparable between both groups. Conclusions: The mechanism of stent expansion influences the degree of vascular injury and healing. The synergistic use of balloon post dilatation changes the dynamics of healing and may impact the potential beneficial effects inherent to SES technologies.

Stents for colorectal obstruction: Past, present, and future

PubMed Central

Kim, Eui Joo; Kim, Yoon Jae

2016-01-01

Since the development of uncovered self-expanding metal stents (SEMS) in the 1990s, endoscopic stents have evolved dramatically. Application of new materials and new designs has expanded the indications for enteral SEMS. At present, enteral stents are considered the first-line modality for palliative care, and numerous types of enteral stents are under development for extended clinical usage, beyond a merely palliative purpose. Herein, we will discuss the current status and the future development of lower enteral stents. PMID:26811630

Management of embedded metallic stents used in the treatment of grades III and IV subglottic, and upper tracheal stenosis in adults.

PubMed

Sendi, Khalil; Al-Khatib, Talal; Ahmed, Duha G; Tonkul, Al-Baraa

2014-11-01

The aim of this study was to evaluate the post-operative complications of using balloon-expandable metallic stents in treatment of benign, major subglottic and tracheal stenosis in adult patients whom conventional therapy has failed and to demonstrate how to deal with these complications in the long run. A retrospective review of five cases; adlut patiets with benign, major subglottic and upper tracheal stenosis whom were treated with balloon expandable metallic stents at King Abdulaziz University Hospital, in the years between 2008 and 2013. Granulation tissue formed in five of the four cases and restenosis occurred. Other complications encountered were stent infection and dislodgment. The complications were managed by removing the stents surgically via a laryngofissure incision and required the placement of a Montgomery T-tube. Managing the restenosis due to granulation tissue formation around the metallic stents is best achieved by removing the embedded metallic stents surgically via open technique and then by placement of a Montgomery T-tube as a bridging option to successful decannulation. Open surgical procedures remain the mainstay treatment for advanced airway stenosis.

Iliocaval Confluence Stenting for Chronic Venous Obstructions

DOE Office of Scientific and Technical Information (OSTI.GOV)

Graaf, Rick de, E-mail: r.de.graaf@mumc.nl; Wolf, Mark de, E-mail: markthewolf@gmail.com; Sailer, Anna M., E-mail: anni.sailer@mumc.nl

PurposeDifferent techniques have been described for stenting of venous obstructions. We report our experience with two different confluence stenting techniques to treat chronic bi-iliocaval obstructions.Materials and MethodsBetween 11/2009 and 08/2014 we treated 40 patients for chronic total bi-iliocaval obstructions. Pre-operative magnetic resonance venography showed bilateral extensive post-thrombotic scarring in common and external iliac veins as well as obstruction of the inferior vena cava (IVC). Stenting of the IVC was performed with large self-expandable stents down to the level of the iliocaval confluence. To bridge the confluence, either self-expandable stents were placed inside the IVC stent (24 patients, SECS group) ormore » high radial force balloon-expandable stents were placed at the same level (16 patients, BECS group). In both cases, bilateral iliac extensions were performed using nitinol stents.ResultsRecanalization was achieved for all patients. In 15 (38 %) patients, a hybrid procedure with endophlebectomy and arteriovenous fistula creation needed to be performed because of significant involvement of inflow vessels below the inguinal ligament. Mean follow-up was 443 ± 438 days (range 7–1683 days). For all patients, primary, assisted-primary, and secondary patency rate at 36 months were 70, 73, and 78 %, respectively. Twelve-month patency rates in the SECS group were 85, 85, and 95 % for primary, assisted-primary, and secondary patency. In the BECS group, primary patency was 100 % during a mean follow-up period of 134 ± 118 (range 29–337) days.ConclusionStenting of chronic bi-iliocaval obstruction shows relatively high patency rates at medium follow-up. Short-term patency seems to favor confluence stenting with balloon-expandable stents.« less

Iliac artery angioplasty : technique and results.

PubMed

Brountzos, E N; Kelekis, D A

2004-10-01

Percutaneous angioplasty is widely used for the treatment of iliac artery occlusive disease. Access to the ipsi-lateral, or less commonly contralateral, common femoral artery is obtained under local anaesthesia; the lesion is crossed with a guidewire and dilated with an angioplasty balloon catheter. This technique yields excellent immediate results with very few complications. Stent placement is used in lesions not amenable to balloon angioplasty, in complications, and recurrences. Evidence suggests that balloon angioplasty is the procedure of choice for iliac artery occlusive lesions. Stent placement should be reserved for angioplasty failures. However, primary stent placement is indicated in total occlusions. Lesion morphology is an important determinant of immediate success and long-term patency. TASC lesions type A and B are best treated with angioplasty and stenting, while TASC lesions type C and D show better results with surgical treatment. The development of new stent designs may expand the indications of the percutaneous treatment.

Development of asymmetric stent for treatment of eccentric plaque.

PubMed

Syaifudin, Achmad; Takeda, Ryo; Sasaki, Katsuhiko

2018-01-01

The selection of stent and balloon type is decisive in the stenting process. In the treatment of an eccentric plaque obstruction, a symmetric expansion from stent dilatation generates nonuniform stress distribution, which may aggravate fibrous cap prone to rupture. This paper developed a new stent design to treat eccentric plaque using structural transient dynamic analysis in ANSYS. A non-symmetric structural geometry of stent is generated to obtain reasonable stress distribution safe for the arterial layer surrounding the stent. To derive the novel structural geometry, a Sinusoidal stent type is modified by varying struts length and width, adding bridges, and varying curvature width of struts. An end ring of stent struts was also modified to eliminate dogboning phenomenon and to reduce the Ectropion angle. Two balloon types were used to deploy the stent, an ordinary cylindrical and offset balloon. Positive modification results were used to construct the final non-symmetric stent design, called an Asymmetric stent. Analyses of the deformation characteristics, changes in surface roughness and induced stresses within intact arterial layer were subsequently examined. Interaction between the stent and vessel wall was implemented by means of changes in surface roughness and stress distribution analyses. The Palmaz and the Sinusoidal stent were used for a comparative study. This study indicated that the Asymmetric stent types reduced the central radial recoiling and the dogboning phenomenon. In terms of changes in surface roughness and induced stresses, the Asymmetric stent has a comparable effect with that of the Sinusoidal stent. In addition, it could enhance the distribution of surface roughening as expanded by an offset balloon.

Long-term outcome of self expandable metal stents for biliary obstruction in chronic pancreatitis.

PubMed

Waldthaler, Alexander; Schütte, Kerstin; Weigt, Jochen; Kropf, Siegfried; Malfertheiner, Peter; Kahl, Stefan

2013-01-10

Insertion of a self-expandable metal stent is still controversial for treatment of benign common bile duct stenosis but can be a valuable alternative to surgical treatment. Aim of our study was to analyze the efficacy of covered and uncovered self-expandable metal stent in patients with chronic pancreatitis and common bile duct stenosis. Twenty patients with common bile duct stenosis due to alcoholic chronic pancreatitis were retrospective analyzed. All patients had advanced chronic pancreatitis, presenting with calcifications in pancreatic head. Uncovered self-expandable metal stent (uSEMS) were used in 11 patients (3 females, 8 males) while in 9 patients (3 females, 6 males) partially covered self-expandable metal stent (cSEMS) were inserted. All patients treated with self-expandable metal stent had contraindications for surgery. Overall mean follow up time was 155 weeks: 206 (52-412) weeks in uSEMS, and 93 (25-233) weeks in cSEMS, respectively. Stent patency was in mean 118 weeks: 159 (44-412) weeks in uSEMS and 67 (25-150) weeks in cSEMS (P=0.019). In the uSEMS group, reintervention was necessary in 5 patients (45%) due to stent obstruction, whereas in the cSEMS group 4 patients (44%) needed reintervention (2 obstructions, 2 migration). Stent migration is an early complication, compared to obstruction (P<0.05), and in cSEMS obstruction occurred significantly earlier compared to uSEMS (P<0.05). Patency of uSEMS was significantly longer compared to partially cSEMS. Available self-expandable metal stent, unfortunately, do not meet the demands on successful treatment of benign common bile duct stenosis.

Gianturco-Rösch Z stents in tracheobronchial stenoses.

PubMed

Petersen, B D; Uchida, B T; Barton, R E; Keller, F S; Rösch, J

1995-01-01

To evaluate expandable metallic Gianturco-Rösch Z (GRZ) stents for treatment of benign and malignant tracheobronchial stenoses. Six patients, ages 45-73 years, were treated for severe dyspnea with placement of GRZ stents. Three patients had benign tracheal lesions (one tracheomalacia, two postoperative) and received uncovered GRZ stents. Three patients had malignant stenoses at the level of the carina; one received an uncovered stent and the other two received silicone-covered GRZ stents. Two patients with benign lesions responded well to stent placement. One was asymptomatic for a year and then was lost to follow-up; the other improved substantially but died of end-stage lung disease 5 months after stent placement. A third patient with a benign high tracheal lesion did poorly; symptoms recurred secondary to inferior migration of a stent, which was removed surgically at 4 months. All patients with malignant lesions improved symptomatically after stent placement and remained without significant dyspnea until death (from 1 to 6 months). Expandable GRZ stents are promising devices for treatment of benign lesions and offer effective palliation of malignant tracheobronchial stenoses.

Comparison of outcomes among secondary covered metallic, uncovered metallic, and plastic biliary stents in treating occluded primary metallic stents in malignant distal biliary obstruction.

PubMed

Cho, Jae Hee; Jeon, Tae Joo; Park, Jeong Youp; Kim, Hee Man; Kim, Yoon Jae; Park, Seung Woo; Chung, Jae Bock; Song, Si Young; Bang, Seungmin

2011-02-01

The self-expandable metallic stent (SEMS) has been widely used for unresectable malignant biliary obstruction but eventually becomes occluded by tumor ingrowth/overgrowth and sludge. Therefore, we aimed to determine the therapeutic effectiveness of secondary stents and to find differences according to various combinations of the first and second stents for the management of occluded SEMSs in patients with malignant distal biliary obstruction. Between 1999 and November 2008, 77 patients with malignant biliary obstruction underwent secondary biliary stent placement as "stent-in-stent" at three university hospitals in Korea (40 covered, 26 uncovered, and 11 plastic stents). The membrane of the covered SEMS was regarded as the barrier against tumor ingrowth. We categorized the patients into three groups based on whether the covered SEMS was either the first or the second stent: membrane-SEMS (18 covered-covered; 9 covered-uncovered; 22 uncovered-covered SEMS), bare-SEMS (17 uncovered-uncovered SEMS), and plastic stent (3 covered-plastic; 8 uncovered-plastic). The median patency of second stents was 138, 109, and 88 days (covered, uncovered, and plastic stents). The second covered SEMSs had a significantly longer patency than plastic stents (p=0.047). In a multivariate analysis including membrane-SEMS, bare-SEMS, and plastic stent groups, the bare-SEMS had a worse cumulative stent patency (HR=2.04, CI=1.08-3.86) and survival time (HR=2.37, CI=1.25-4.49) than the membrane-SEMS. Patients with ampulla of Vater cancer had better stent patency (HR=0.27, CI=0.08-0.98) and survival (HR=0.17, CI=0.04-0.77) than those with other pancreatobiliary malignancies. In addition, antitumor treatment prolonged survival time (HR=0.50, CI=0.26-0.99). The placement of additional biliary stents using the "stent-in-stent" method is an effective treatment for an occluded metallic primary stent. In addition, double biliary SEMS placement using at least one covered SEMS (in the primary and/or secondary procedure) might provide longer cumulative stent patency and survival than using uncovered SEMSs in both procedures.

Successful Expansion of an Underexpanded Stent by Rotational Atherectomy

PubMed Central

Vales, Lori; Coppola, John; Kwan, Tak

2013-01-01

The current routine use of intracoronary stents in percutaneous coronary intervention (PCI) has significantly reduced rates of restenosis, compared with balloon angioplasty alone. On the contrary, small post-stenting luminal dimensions due to undilatable, heavily calcified plaques have repeatedly been shown to significantly increase the rates of in-stent restenosis. Rotational atherectomy of lesions is an alternative method to facilitate PCI and prevent underexpansion of stents, when balloon angioplasty fails to successfully dilate a lesion. Stentablation, using rotational atherectomy to expand underexpanded stents deployed in heavily calcified plaques, has also been reported. We report a case via the transradial approach of rotational-atherectomy–facilitated PCI of in-stent restenosis of a severely underexpanded stent due to a heavily calcified plaque. We review the literature and suggest rotational atherectomy may have a role in treating a refractory, severely underexpanded stent caused by a heavily calcified plaque through various proposed mechanisms. PMID:24436587

Partially covered metal stents have longer patency than uncovered and fully covered metal stents in the management of distal malignant biliary obstruction: a retrospective study.

PubMed

Yokota, Yudai; Fukasawa, Mitsuharu; Takano, Shinichi; Kadokura, Makoto; Shindo, Hiroko; Takahashi, Ei; Hirose, Sumio; Kawakami, Satoshi; Fukasawa, Yoshimitsu; Sato, Tadashi; Enomoto, Nobuyuki

2017-10-11

Self-expandable metal stents (SEMSs) are widely used for malignant biliary obstructions. Nitinol-covered SEMSs have been developed to improve stent patency. Currently, SEMSs may be uncovered, partially covered, or fully covered; however, there is no consensus on the best stent type for the management of malignant distal biliary obstruction (MDBO). Patients with unresectable MDBO receiving SEMS (Wallflex™) were retrospectively analyzed. Time to recurrent biliary obstruction (TRBO) and survival time were compared among the three types of SEMSs. Univariate and multivariate analyses were performed to identify risk factors for stent dysfunction. In total, 101 patients received SEMSs for unresectable MDBO (44 uncovered, 28 partially covered, and 29 fully covered SEMSs). Median survival time was 200, 168, and 276 days in the uncovered, partially covered, and fully covered SEMSs groups, respectively. There were no differences in survival among the three groups. Median TRBO was 199, 444, and 194 days in the uncovered, partially covered, and fully covered SEMSs groups, respectively. Partially covered SEMSs had longer TRBO than uncovered (p = 0.013) and fully covered (p = 0.010) SEMSs. Tumor ingrowth occurred only with uncovered SEMSs and stent migration occurred only with fully covered SEMSs. Multivariate analyses confirmed that partially covered SEMSs have lower risk of dysfunction. Partially covered SEMSs with a proximal uncovered flared end have longer patency than uncovered and fully covered SEMSs by preventing tumor ingrowth and stent migration.

Medium-term follow-up after deployment of ultraflex expandable metallic stents to manage endobronchial pathology.

PubMed

Madden, Brendan P; Park, John E S; Sheth, Abhijat

2004-12-01

Between March 1997 and March 2004 we deployed 80 Ultraflex metallic expandable stents (Boston Scientific, Waterson, MA) in 69 patients under direct vision using rigid bronchoscopy. We report our medium- to long-term experience in patients for whom these stents were deployed. To date 15 patients have been followed for more than 1 year (median 41 months, range 12 to 83 months) after stent deployment. Indications for stenting in these patients were neoplasia (5), stricture (5), airway malacia (1), iatrogenic tracheal tear (1), and compression from an aortic aneurysm (1), a right interrupted aortic arch (1), and a right brachiocephalic artery aneurysm with tracheomalacia (1). Ten tracheal stents (9 covered, 1 uncovered) and 10 bronchial stents (8 uncovered, 2 covered) were inserted, and 5 patients received two stents. Five of these patients experienced no long-term problems. Complications included troublesome halitosis (5), which was difficult to treat despite various antibiotic regimes; granulation tissue formation above and below the stent that was successfully treated with low-power Nd:YAG laser therapy (7); and metal fatigue (1). We did not encounter stent migration. We conclude that Ultraflex expandable metallic stents have an important role in the management of selected patients with diverse endobronchial pathologies and are well tolerated in the long-term. Although associated granulation tissue can be successfully treated with Nd:YAG laser, halitosis can be a difficult problem to address.

Covered self-expandable metal stents with an anti-migration system improve patency duration without increased complications compared with uncovered stents for distal biliary obstruction caused by pancreatic carcinoma: a randomized multicenter trial.

PubMed

Kitano, Masayuki; Yamashita, Yukitaka; Tanaka, Kiyohito; Konishi, Hideyuki; Yazumi, Shujiro; Nakai, Yoshitaka; Nishiyama, Osamu; Uehara, Hiroyuki; Mitoro, Akira; Sanuki, Tsuyoshi; Takaoka, Makoto; Koshitani, Tatsuya; Arisaka, Yoshifumi; Shiba, Masatsugu; Hoki, Noriyuki; Sato, Hideki; Sasaki, Yuichi; Sato, Masako; Hasegawa, Kazunori; Kawabata, Hideaki; Okabe, Yoshihiro; Mukai, Hidekazu

2013-11-01

The requirements of biliary stents used in the palliation of malignant biliary obstruction are a long duration of patency and minimal adverse effects. Covered self-expandable metal stents (SEMSs) have been shown to prevent tumor ingrowth, which is the most frequent complication of uncovered SEMSs. However, because they are prone to migration, the superiority of covered SEMS has yet to be convincingly demonstrated. The aim of this study was to evaluate the superiority of covered over uncovered SEMSs in the palliation of distal biliary obstruction due to unresectable pancreatic carcinoma, using both stent types with relatively low axial force and uncovered flared ends to prevent their migration. From April 2009 to December 2010, 120 patients who were admitted to 22 tertiary-care centers because of distal biliary obstruction from unresectable pancreatic carcinomas were enrolled in this prospective randomized multicenter study. Patients were randomly assigned to receive a covered or uncovered SEMS deployed at the site of the biliary stricture during endoscopic retrograde cholangiopancreatography. Stent patency time, patient survival time, patient survival time without stent dysfunction (time to stent dysfunction or patient death), cause of stent dysfunction (ingrowth, overgrowth, migration, or sludge formation), and serious adverse events were compared between covered and uncovered SEMS groups. Patient survival time in the two groups did not significantly differ (median: 285 and 223 days, respectively; P=0.68). Patient survival time without stent dysfunction was significantly longer in the covered than in the uncovered SEMS group (median: 187 vs. 132 days; P=0.043). Stent patency was also significantly longer in the covered than in the uncovered SEMS group (mean±s.d.: 219.3±159.1 vs. 166.9±124.9 days; P=0.047). Reintervention for stent dysfunction was performed in 14 of 60 patients with covered SEMSs (23%) and in 22 of 60 patients with uncovered SEMSs (37%; P=0.08). Stent dysfunction was caused by tumor ingrowth, tumor overgrowth, and sludge formation in 0 (0%), 3 (5%), and 11 (18%) patients in the covered SEMSs group, and in 15 (25%), 2 (3%), and 6 (10%) patients in the uncovered SEMSs group, respectively. Stent migration was not observed in either group. Rates of tumor overgrowth and sludge formation did not significantly differ between the two groups, whereas the rate of tumor ingrowth was significantly lower in the covered than in the uncovered SEMS group (P<0.01). Acute pancreatitis occurred in only one patient in the covered SEMS group. Acute cholecystitis occurred in one patient in the covered SEMS group and in two patients in the uncovered SEMS group. There was no significant difference between the two groups in the incidence of serious adverse events. By preventing tumor ingrowth and migration, covered SEMSs with an anti-migration system had a longer duration of patency than uncovered SEMSs, which recommends their use in the palliative treatment of patients with biliary obstruction due to pancreatic carcinomas.

77 FR 15779 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-16

... 26, 2011. iliac balloon- expandable stent system. P100042, FDA-2011-M-0792 Gen-Probe APTIMA HPV assay..., 2011. XIENCE PRIME LL EVEROLIMUS-eluting coronary stent system. P100041, FDA-2011-M-0837 Edwards.... EVEROLIMUS-eluting platinum chromium coronary stent system. P100024, FDA-2011-M-0866 Dako Denmark A/S...

Recanalization Results After Intracranial Stenting of Atherosclerotic Stenoses

DOE Office of Scientific and Technical Information (OSTI.GOV)

Blasel, Stella, E-mail: Stella.Blasel@kgu.de; Yuekzek, Zeynep; Kurre, Wiebke

2010-10-15

The purpose of this investigation was to provide a detailed description of the angiographic results after stenting of high-grade intracranial stenosis using balloon-expandable stents. Forty consecutive patients with symptomatic atherosclerotic intracranial stenosis >50% received endovascular treatment by placement of balloon-expandable stents using the concept of slight underdilation and strict avoidance of overdilation. Intra-arterial digital subtraction angiography images before and after stenting in the same projection were reviewed for pre- and post-therapeutic measurement of the degree of stenosis and evaluation of morphologic criteria like plaque coverage, stent apposition, patency of side branches, and signs of dissection or vasospasm. Stenting decreased themore » mean percentage stenosis from 76.2 (WASID criteria) to 20.8%. Residual stenosis ranged from 0 to 55% with residual stenosis >50% in two of 40 cases. Technical success rate was 95%. There were no major vessel complications, but minor abnormalities like incomplete stent apposition (8/40) or plaque coverage (7/40), incomplete filling of side branches (13/40), and minor dissections after stenting (2/40) were seen. One case with incomplete stent apposition and two cases with side branch compromise were associated with clinical symptoms. In conclusion, intracranial stenting with slight underdilation avoided major vessel complication and created reliable luminal gain. Suboptimal recanalization results were frequently detected and may be the source of neurological complications in individual cases.« less

Below-the-ankle Angioplasty and Stenting for Limb Salvage: Anatomical Considerations and Long-term Outcomes

DOE Office of Scientific and Technical Information (OSTI.GOV)

Katsanos, Konstantinos, E-mail: katsanos@med.upatras.gr; Diamantopoulos, Athanasios; Spiliopoulos, Stavros

2013-08-01

PurposeTo report the long-term angiographic and clinical results in a series of below-the-ankle (BTA) angioplasty procedures and to present some biomechanical issues related to the unique anatomical geometry of the ankle.MethodsWe performed a retrospective analysis of BTA angioplasty procedures. Clinical end points included technical success, patient mortality, salvage of the treated foot, and repeat target lesion revascularization. Imaging end points included primary patency, binary restenosis of the target lesion at the 50 % threshold, and stent integrity (stent fracture, deformation, or collapse). Univariate subgroup analysis was performed.ResultsIn total, 40 limbs in 37 patients (age 73.5 {+-} 8.2 years) with criticalmore » limb ischemia were included and 42 inframalleolar lesions (4.2 {+-} 1.4 cm) were analyzed. Technical success was achieved in 95.2 % (40 of 42). Provisional stent placement was performed in 45.2 % (19 of 42). Two patients died, and two major amputations occurred up to 3 years. At 1 year, overall primary vessel patency was 50.4 {+-} 9.1 %, lesion binary restenosis rate was 64.1 {+-} 8.3 %, and repeat intervention-free survival was 93.6 {+-} 4.3 % according to life table analysis of all treated lesions. Pairwise subgroup analysis showed that BTA self-expanding stents were associated with significantly higher restenosis and poorer primary patency compared to plain balloon angioplasty or sirolimus-eluting balloon-expandable stents. Significant deformation and/or fracture of balloon-expandable stents placed BTA were identified in five of 11. Dynamic imaging showed that the dorsalis pedis artery is kinked during foot dorsiflexion, whereas the distal posterior tibial artery is kinked during plantar flexion of the foot.ConclusionBTA angioplasty for critical limb ischemia treatment is safe and feasible with satisfactory long-term results. BTA stent placement must be reserved for bailout indications.« less

[Interventional radiology in treatment of biliodigestive anastomoses strictures].

PubMed

Okhotnikov, O I; Yakovleva, M V; Grigoriev, S N

2016-01-01

To analyze efficacy of interventional methods via antegrade transhepatic approach in treatment of patients with strictures of biliodigestive anastomoses. 24 patients aged 47.2 years were treated for the period 2002-2015. Average time from extrahepatic biliary reconstruction using transhepatic stented tubes to strictures appearance varied from 9 months to 12 years. One- and double-sided percutaneous transhepatic cholangiostomy was performed to abort biliary hypertension. Stricture recanalization was achieved using «catheter-wire» system. Antegrade dilatation of stricture was made using balloon catheter 8 mm and pressure up to 6 atm and stage exposition up to 10 minutes. Balloon repair of anastomosis was supplemented by stented outer-inner drainage of the area of stricture. Restoration of patency of stricture area using antegrade interventional methods was effective in 22 patients. Recurrent stricture occurred in 2 cases within 1.5 years that required repeated biliary reconstruction including antegrade extraction of blocked uncovered stent in 1 patient. There were no major postoperative complications and deaths. Maximal recurrence-free follow-up after stent installation was 11 years.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Vajda, Zsolt, E-mail: Z.Vajda@klinikum-stuttgart.de; Guethe, Thomas, E-mail: T.Guethe@klinikum-stuttgart.de; Perez, Marta Aguilar, E-mail: M.Aguilar@klinikum-stuttgart.de

Stenting in intracranial atherosclerotic disease (ICAD) is increasingly debated, due to issues of procedural safety, technical efficacy, and in-stent recurrent stenoses (ISR). In the present study, feasibility, safety, and efficacy of angioplasty using a drug-eluting balloon (DEB) followed by the implantation of a self-expanding stent (Enterprise) were evaluated for the treatment of ICAD lesions. Fifty-two patients (median age: 71 years; range: 54-86 years; male/female ratio 37:15) underwent stenting of high-grade ICAD lesions between February 2010 and November 2011 in a single center. Angioplasty using a paclitaxel coated SeQuent Please (B. Braun, Germany) or DIOR (Eurocor, Germany) coronary PTCA balloon, followedmore » by the implantation of a self-expanding stent (Enterprise, Codman, USA) was performed in 54 lesions. Angiographic and clinical follow-up was performed at 6 and 12 weeks, 6 and 12 months, and yearly thereafter. Technical success rate, periprocedural complications, occurrence of recurrent ischemic symptoms, and the development of an ISR were analyzed. Angioplasty using a DEB followed by stent implantation was successfully performed in 44 (81 %) cases. DEB insertion failed in 19 % of the cases and angioplasty was finally performed using a conventional PTCA balloon. The combined procedure related permanent neurologic morbidity and mortality rate (stroke, ICH, and subarachnoid hemorrhage) at 30 days and beyond was 5 %. Angiographic and clinical follow-up were obtained in 33 (61 %) lesions in 32 patients. Recurrent stenosis was seen in one (3 %) lesion. Angioplasty and stenting using a DEB is safe and yields encouragingly low ISR rates. Further technical developments to improve lesion accessibility are, nevertheless, mandatory.« less

Predictors of stent dysfunction after self-expandable metal stent placement for malignant gastric outlet obstruction: tumor ingrowth in uncovered stents and migration of covered stents.

PubMed

Hori, Yasuki; Naitoh, Itaru; Hayashi, Kazuki; Ban, Tesshin; Natsume, Makoto; Okumura, Fumihiro; Nakazawa, Takahiro; Takada, Hiroki; Hirano, Atsuyuki; Jinno, Naruomi; Togawa, Shozo; Ando, Tomoaki; Kataoka, Hiromi; Joh, Takashi

2017-10-01

Endoscopic metallic stenting is widely accepted as a palliation therapy for malignant gastric outlet obstruction (GOO). However, the predictors of stent dysfunction have not been clarified. We aimed to evaluate the predictors, especially tumor ingrowth in uncovered self-expandable metallic stents (U-SEMS) and migration of covered self-expandable metallic stents (C-SEMS), which are the main causes related to the stent characteristics. In this multicenter retrospective study, we compared patients with U-SEMS and C-SEMS in terms of clinical outcomes, and predictors of stent dysfunction. In total, 252 patients (126 with U-SEMS and 126 with C-SEMS) were enrolled. There were no significant differences in technical success, clinical success, GOO score, or time to stent dysfunction. Tumor ingrowth was significantly more frequent in U-SEMS (U-SEMS, 11.90% vs. C-SEMS, 0.79%; p = 0.002), and stent migration was significantly more frequent for C-SEMS (C-SEMS, 8.73% vs. U-SEMS, 0.79%; p = 0.005). Karnofsky performance status (p = 0.04), no presence of ascites (p = 0.02), and insufficient (<30%) stent expansion (p = 0.003) were significantly associated with tumor ingrowth in U-SEMS. Meanwhile, a shorter stent length (p = 0.05) and chemotherapy (p = 0.03) were predictors of C-SEMS migration. Both U-SEMS and C-SEMS are effective with comparable patencies. Tumor ingrowth and stent migration are the main causes of stent dysfunction for U-SEMS and C-SEMS, respectively. With regard to stent dysfunction, U-SEMS might be a good option for patients receiving chemotherapy, while C-SEMS with longer stents for patients in good condition. (Clinical trial registration number: UMIN000024059).

A prospective randomized study for efficacy of an uncovered double bare metal stent compared to a single bare metal stent in malignant biliary obstruction.

PubMed

Lee, Hyun Jik; Chung, Moon Jae; Park, Jeong Yup; Park, Seung Woo; Nam, Chung Mo; Song, Si Young; Bang, Seungmin

2017-08-01

A biliary self-expandable metal stent (SEMS) is commonly used to relieve malignant biliary obstruction. The aim of this study was to compare the efficacy of a conventional uncovered SEMS with that of a newly developed uncovered double bare metal stent in reducing the risk of stent occlusion caused by tumor ingrowth. We performed a prospective, open-labeled, randomized trial in 71 patients at Severance Hospital, Yonsei University College of Medicine from June 2013 to June 2014. Patients with inoperable malignant biliary obstruction were included and randomized to receive an uncovered single bare metal stent (SBSs; S&G Biotech Inc.), an uncovered single bare metal stent (SBSt; Taewoong Medical), or an uncovered double bare metal stent (DBS; S&G Biotech Inc.). The mean age was 66.6 years (range, 35-83), and 42 (59.2%) were male. The mean duration of stent patency was 212 days (±152) in the DBS group (n = 24) compared with 124 days (±98) in the SBSs group (n = 23; P = 0.022 for noninferiority) and 116 days (±79) in the SBSt group (n = 24; P = 0.010 for noninferiority). There were no differences in the incidences of early and delayed complications or migration. The newly developed DBS is noninferior to the conventional uncovered SEMSs on duration of stent patency and tumor ingrowth occurred less frequently in the DBS group. This might decrease the need for reintervention and offer a better quality of life. The trial is registered with Clinicaltrials.gov no: NCT01869894.

Partial stent-in-stent placement of biliary metallic stents using a short double-balloon enteroscopy.

PubMed

Tsutsumi, Koichiro; Kato, Hironari; Tomoda, Takeshi; Matsumoto, Kazuyuki; Sakakihara, Ichiro; Yamamoto, Naoki; Noma, Yasuhiro; Sonoyama, Takayuki; Okada, Hiroyuki; Yamamoto, Kazuhide

2012-12-07

Endoscopic intervention is less invasive than percutaneous or surgical approaches and should be considered the primary drainage procedure in most cases with obstructive jaundice. Recently, therapeutic endoscopic retrograde cholangiopancreatography (ERCP) using double-balloon enteroscopy (DBE) has been shown to be feasible and effective, even in patients with surgically altered anatomies. On the other hand, endoscopic partial stent-in-stent (PSIS) placement of self-expandable metallic stents (SEMSs) for malignant hilar biliary obstruction in conventional ERCP has also been shown to be feasible, safe and effective. We performed PSIS placement of SEMSs for malignant hilar biliary obstruction due to liver metastasis using a short DBE in a patient with Roux-en-Y anastomosis and achieved technical and clinical success. This procedure can result in quick relief from obstructive jaundice in a single session and with short-term hospitalization, even in patients with surgically altered anatomies.

Stent coverage and neointimal proliferation in bare metal stents postdilated with a Paclitaxel-eluting balloon versus everolimus-eluting stents: prospective randomized study using optical coherence tomography at 6-month follow-up.

PubMed

Poerner, Tudor C; Otto, Sylvia; Gassdorf, Johannes; Nitsche, Kristina; Janiak, Florian; Scheller, Bruno; Goebel, Björn; Jung, Christian; Figulla, Hans R

2014-12-01

In this randomized trial, strut coverage and neointimal proliferation of a therapy of bare metal stents (BMSs) postdilated with the paclitaxel drug-eluting balloon (DEB) was compared with everolimus drug-eluting stents (DESs) at 6-month follow-up using optical coherence tomography. We hypothesized sufficient stent coverage at follow-up. A total of 105 lesions in 90 patients were treated with either XIENCE V DES (n=51) or BMS postdilated with the SeQuent Please DEB (n=54). At follow-up, comparable results on the primary optical coherence tomography end point (percentage uncovered struts 5.64±9.65% in BMS+DEB versus 4.93±9.29% in DES; P=0.366) were found. Thus, BMS+DEB achieved the prespecified noninferiority margin of 5% uncovered struts versus DES (difference between treatment means, 0.71%; one-sided upper 95% confidence interval, 4.14%; noninferiority P=0.04). Optical coherence tomography analysis showed significantly more global neointimal proliferation in the BMS+DEB group (15.7±7.8 versus 11.0±5.2 mm(3) proliferation volume/cm stent length; P=0.002). No significant focal in-stent stenosis analyzed with angiography (percentage diameter stenosis at follow-up, 22.8±11.9 versus 16.9±10.4; P=0.014) and optical coherence tomography (peak local area stenosis, 39.5±13.8% versus 36.8±15.6%; P=0.409) was found. Good stent strut coverage of >94% was found in both therapy groups. Despite greater suppression of global neointimal growth in DES, both DES and BMS+DEB effectively prevented clinically relevant focal restenosis at 6-month follow-up. http://www.clinicaltrials.gov. Unique identifier: NCT01056744. © 2014 American Heart Association, Inc.

Stent placement for palliation of cor triatriatum dexter in a dog with suspected patent foramen ovale.

PubMed

Barncord, Kristin; Stauthammer, Christopher; Moen, Sean L; Hanson, Melissa; Gruenstein, Daniel H

2016-03-01

An 11 month old spayed, female dog presented with exercise intolerance and cyanosis upon exertion. Echocardiography revealed an imperforate cor triatriatum dexter with mild tricuspid valve dysplasia, an underfilled right ventricle and significant right to left shunting across a presumptive patent foramen ovale. Balloon dilation of the abnormal atrial membrane was initially successful in creating a communication between the right atrial chambers, but stenosis of the original perforation and persistent clinical signs prompted a second intervention. A balloon expandable biliary stent was placed across the abnormal partition, improving caudal venous return to the right ventricle and reducing the right to left shunt. Three months after stent placement, resting oxygen saturation had normalized. Six months after stent placement, exercise tolerance had improved and exertional cyanosis had resolved. Long term follow up will be necessary to assess for remodeling of the right ventricle with improved venous return. Stent placement can be considered as a palliative treatment option for cor triatriatum dexter, especially for stenosis post-balloon dilation. Copyright © 2015 Elsevier B.V. All rights reserved.

Serial Versus Direct Dilation of Small Diameter Stents Results in a More Predictable and Complete Intentional Transcatheter Stent Fracture: A PICES Bench Testing Study.

PubMed

Crystal, Matthew A; Morgan, Gareth J; Danon, Saar; Gray, Robert G; Gruenstein, Daniel H; Gordon, Brent M; Goldstein, Bryan H

2018-01-01

Balloon-expandable stents, implanted in infants and children with congenital heart disease (CHD), often require redilation to match somatic growth. Small diameter stents may eventually require longitudinal surgical transection to prevent iatrogenic vascular stenosis. Intentional transcatheter stent fracture (TSF) is an emerging alternative approach to stent transection, but little is known about the optimal stent substrate and best protocol to improve the likelihood of successful TSF. Bench testing was performed with a stent dilation protocol. After recording baseline characteristics, stents were serially or directly dilated using ultra-high-pressure balloons (UHPB) until fracture occurred or further stent dilation was not possible. Stent characteristics recorded were as follows: cell design, metallurgy, mechanism, and uniformity of fracture. Stents tested included bare-metal coronary stents, premounted small diameter stents, and ePTFE-covered small diameter premounted stents. Ninety-four stents representing 9 distinct models were maximally dilated, with 80 (85%) demonstrating evidence of fracture. Comprehensive fracture details were recorded in 64 stents: linear and complete in 34/64 stents (53.1%), linear and incomplete in 9/64 stents (14.1%), transverse/complex and complete in 6/64 stents (9.4%), and transverse/complex and incomplete in 15/64 stents (23.4%). Stent fracture was not accomplished in some stent models secondary to significant shortening, i.e., "napkin-ring" formation. Serial dilation resulted in evidence of fracture in 62/67 (92.5%) stents compared with 18/27 (66.7%) stents in the direct dilation group (p = 0.003). Intentional TSF is feasible in an ex vivo model. Serial dilation more reliably expanded the stent and allowed for ultimate stent fracture, whereas direct large diameter dilation of stents was more likely to generate a "napkin-ring" configuration, which may be more resistant to fracture. In vivo animal and human testing is necessary to better understand the response to attempted TSF for newly developed stents as well as those currently in use.

Utility of the balloon-overtube-assisted modified over-the-wire stenting technique to treat post-sleeve gastrectomy complications.

PubMed

Ponte, Ana; Pinho, Rolando; Proença, Luísa; Silva, Joana; Rodrigues, Jaime; Sousa, Mafalda; Silva, João Carlos; Carvalho, João

2017-06-16

To describe a modified technique of deployment of stents using the overtube developed for balloon-assisted enteroscopy in post-sleeve gastrectomy (SG) complications. Between January 2010 and December 2015, all patients submitted to an endoscopic stenting procedure to treat a post-SG stenosis or leakage were retrospectively collected. Procedures from patients in which the stent was deployed using the balloon-overtube-assisted modified over-the-wire (OTW) stenting technique were described. The technical success, corresponding to proper placement of the stent in the stomach resulting in exclusion of the SG leak or the stenosis, was evaluated. Complications related to stenting were also reported. Five procedures were included to treat 2 staple line leaks and 3 stenoses. Two types of stents were used, including a fully covered self-expandable metal stent designed for the SG anatomy (Hanarostent, ECBB-30-240-090; M.I. Tech, Co., Ltd, Seoul, South Korea) in 4 procedures and a biodegradable stent (BD stent 019-10A-25/20/25-080, SX-ELLA, Hradec Kralove, Czech Republic) in the remaining procedure. In all cases, an overtube was advanced with the endoscope through the SG to the duodenum. After placement of the guidewire and removal of the endoscope, the stent was easily advanced through the overtube. The overtube was pulled back and the stent was successfully deployed under fluoroscopic guidance. Technical success was achieved in all patients. The adoption of a modified technique of deployment of OTW stents using an overtube may represent an effective option in the approach of SG complications.

Utility of the balloon-overtube-assisted modified over-the-wire stenting technique to treat post-sleeve gastrectomy complications

PubMed Central

Ponte, Ana; Pinho, Rolando; Proença, Luísa; Silva, Joana; Rodrigues, Jaime; Sousa, Mafalda; Silva, João Carlos; Carvalho, João

2017-01-01

AIM To describe a modified technique of deployment of stents using the overtube developed for balloon-assisted enteroscopy in post-sleeve gastrectomy (SG) complications. METHODS Between January 2010 and December 2015, all patients submitted to an endoscopic stenting procedure to treat a post-SG stenosis or leakage were retrospectively collected. Procedures from patients in which the stent was deployed using the balloon-overtube-assisted modified over-the-wire (OTW) stenting technique were described. The technical success, corresponding to proper placement of the stent in the stomach resulting in exclusion of the SG leak or the stenosis, was evaluated. Complications related to stenting were also reported. RESULTS Five procedures were included to treat 2 staple line leaks and 3 stenoses. Two types of stents were used, including a fully covered self-expandable metal stent designed for the SG anatomy (Hanarostent, ECBB-30-240-090; M.I. Tech, Co., Ltd, Seoul, South Korea) in 4 procedures and a biodegradable stent (BD stent 019-10A-25/20/25-080, SX-ELLA, Hradec Kralove, Czech Republic) in the remaining procedure. In all cases, an overtube was advanced with the endoscope through the SG to the duodenum. After placement of the guidewire and removal of the endoscope, the stent was easily advanced through the overtube. The overtube was pulled back and the stent was successfully deployed under fluoroscopic guidance. Technical success was achieved in all patients. CONCLUSION The adoption of a modified technique of deployment of OTW stents using an overtube may represent an effective option in the approach of SG complications. PMID:28690770

Covered stent to exclude intravascular thrombus.

PubMed

Liistro, Francesco; Stankovic, Goran; Di Mario, Carlo; Montorfano, Matteo; Briguori, Carlo; Colombo, Antonio

2002-04-01

To describe the utility of stent-graft implantation to avoid distal embolization from a large thrombus-containing lesion. A 67-year-old man was evaluated for recent onset of disabling left leg claudication. Angiography disclosed a mobile lobular mass occluding the left common iliac artery; irregular staining suggested an atherothrombotic lesion. Through a percutaneous ipsilateral access and an 8-F sheath, a balloon-expandable Jostent peripheral stent-graft was positioned with the distal edge immediately proximal to the internal iliac artery ostium. A prominent "waist" at the center of the balloon confirmed entrapment of the thrombotic mass. Completion angiography showed an optimal result with no residual stenosis or evidence of distal embolization. At 6-month follow-up, the patient was asymptomatic with angiographically documented luminal patency and no evidence of in-stent stenosis. Stent-graft implantation appears a viable treatment alternative for thrombus-containing lesions, particularly when the thrombotic material is localized or is in a large vessel.

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

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hautmann, Hubert; Rieger, Johannes; Huber, Rudolf M.

1999-03-15

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 implantationmore » 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.« less

A recoil resilient lumen support, design, fabrication and mechanical evaluation

NASA Astrophysics Data System (ADS)

Mehdizadeh, Arash; Ali, Mohamed Sultan Mohamed; Takahata, Kenichi; Al-Sarawi, Said; Abbott, Derek

2013-06-01

Stents are artificial implants that provide scaffolding to a cavity inside the body. This paper presents a new luminal device for reducing the mechanical failure of stents due to recoil, which is one of the most important issues in stenting. This device, which we call a recoil-resilient ring (RRR), is utilized standalone or potentially integrated with existing stents to address the problem of recoil. The proposed structure aims to minimize the need for high-pressure overexpansion that can induce intra-luminal trauma and excess growth of vascular tissue causing later restenosis. The RRR is an overlapped open ring with asymmetrical sawtooth structures that are intermeshed. These teeth can slide on top of each other, while the ring is radially expanded, but interlock step-by-step so as to keep the final expanded state against compressional forces that normally cause recoil. The RRRs thus deliver balloon expandability and, when integrated with a stent, bring both radial rigidity and longitudinal flexibility to the stent. The design of the RRR is investigated through finite element analysis (FEA), and then the devices are fabricated using micro-electro-discharge machining of 200-µm-thick Nitinol sheet. The standalone RRR is balloon expandable in vitro by 5-7 Atm in pressure, which is well within the recommended in vivo pressure ranges for stenting procedures. FEA compression tests indicate 13× less reduction of the cross-sectional area of the RRR compared with a typical stainless steel stent. These results also show perfect elastic recovery of the RRR after removal of the pressure compared to the remaining plastic deformations of the stainless steel stent. On the other hand, experimental loading tests show that the fabricated RRRs have 2.8× radial stiffness compared to a two-column section of a commercial stent while exhibiting comparable elastic recovery. Furthermore, testing of in vitro expansion in a mock artery tube shows around 2.9% recoil, approximately 5-11× smaller than the recoil reported for commercial stents. These experimental results demonstrate the effectiveness of the device design for the targeted luminal support and stenting applications.

In-situ investigation of stress conditions during expansion of bare metal stents and PLLA-coated stents using the XRD sin(2)ψ-technique.

PubMed

Kowalski, Wolfgang; Dammer, Markus; Bakczewitz, Frank; Schmitz, Klaus-Peter; Grabow, Niels; Kessler, Olaf

2015-09-01

Drug eluting stents (DES) consist of platform, coating and drug. The platform often is a balloon-expandable bare metal stent made of the CoCr alloy L-605 or stainless steel 316 L. The function of the coating, typically a permanent polymer, is to hold and release the drug, which should improve therapeutic outcome. Before implantation, DES are compressed (crimped) to allow implantation in the human body. During implantation, DES are expanded by balloon inflation. Crimping, as well as expansion, causes high stresses and high strains locally in the DES struts, as well as in the polymer coating. These stresses and strains are important design criteria of DES. Usually, they are calculated numerically by finite element analysis (FEA), but experimental results for validation are hardly available. In this work, the X-ray diffraction (XRD) sin(2)ψ-technique is applied to in-situ determination of stress conditions of bare metal L-605 stents, and Poly-(L-lactide) (PLLA) coated stents. This provides a realistic characterization of the near-surface stress state and a validation option of the numerical FEA. XRD-results from terminal stent struts of the bare metal stent show an increasing compressive load stress in tangential direction with increasing stent expansion. These findings correlate with numerical FEA results. The PLLA-coating also bears increasing compressive load stress during expansion. Copyright © 2015 Elsevier Ltd. All rights reserved.

Stent placement for benign colonic stenosis: case report, review of the literature, and animal pilot data.

PubMed

Geiger, Timothy M; Miedema, Brent W; Tsereteli, Zurab; Sporn, Emanuel; Thaler, Klaus

2008-10-01

Permanent metal stent placement for malignant intestinal obstruction has been proven to be efficient. Temporary stents for benign conditions of the colon and rectum are less studied. This is a case study, review of the literature, and observation from an animal model on placement of stents in the colorectum for benign disease. A 55-year-old man presented with recurrent obstructions from a benign stricture of the distal sigmoid colon. After failed balloon dilations, a polyester coated stent was placed. The purpose of the stent was to improve symptoms and avoid surgery. The stent was expelled after 5 days. We conducted a literature review of stents placed for benign colorectal strictures and an animal study to evaluate stent migration. In the literature, there were 53 reports of uncovered metal stents, four covered metal stents, and six polyester stents. Patency rates were 71%, and migration rate was 43%. Migration occurred earlier with polyester stents (mean=8 days) versus covered (32 days) or uncovered metal stents (112 days). Severe complications were seen in 23% of patients. Four 45-kg pigs underwent rectosigmoid transection with a 21-mm anastomosis and endoscopic placement of a Polyflex stent. Two stents were secured with suture. Stents without fixation were expelled within 24 h of surgery. Stents with fixation were expelled between postoperative days 2 and 14. Stents for the treatment of benign colorectal strictures are safe, with comparable patency rates between stent types. Metal stents can cause severe complications. In a pig model, covered polyester stents tend to migrate early even with fixation. Further investigation needs to focus on new stent designs and/or better fixation.

Mechanical behavior of peripheral stents and stent-vessel interaction: A computational study

NASA Astrophysics Data System (ADS)

Dottori, Serena; Flamini, Vittoria; Vairo, Giuseppe

2016-05-01

In this paper stents employed to treat peripheral artery disease are analyzed through a three-dimensional finite-element approach, based on a large-strain and large-displacement formulation. Aiming to evaluate the influence of some stent design parameters on stent mechanics and on the biomechanical interaction between stent and arterial wall, quasi-static and dynamic numerical analyses are carried out by referring to computational models of commercially and noncommercially available versions of both braided self-expandable stents and balloon-expandable stents. Addressing isolated device models, opening mechanisms and flexibility of both opened and closed stent configurations are numerically experienced. Moreover, stent deployment into a stenotic peripheral artery and possible postdilatation angioplasty (the latter for the self-expandable device only) are simulated by considering different idealized vessel geometries and accounting for the presence of a stenotic plaque. Proposed results highlight important differences in the mechanical response of the two types of stents, as well as a significant influence of the vessel shape on the stress distributions arising upon the artery-plaque system. Finally, computational results are used to assess both the stent mechanical performance and the effectiveness of the stenting treatment, allowing also to identify possible critical conditions affecting the risk of stent fracture, tissue damage, and/or pathological tissue response.

The use of expandable metallic airway stents for tracheobronchial obstruction in children.

PubMed

Filler, R M; Forte, V; Fraga, J C; Matute, J

1995-07-01

Expandable metallic angioplasty stents (Palmaz stent) have been implanted in the trachea and/or bronchi of seven children. Three children had severe tracheal stenosis after tracheoplasty for congenital tracheal stenosis repair, and four had tracheomalacia or bronchomalacia with or without vascular compression. The mean age at stenting was 9.7 months (range, 2 to 15 months). Balloon expandable stents were inserted into the trachea or bronchus through a 3.5-mm bronchoscope under fluoroscopic control. Initially a single tracheal stent was used for all patients except for one with obstruction in the trachea and both bronchi, in whom three stents were implanted. Three children had recurrent airway obstruction 1 month later; one was cured with a second stent; one child died 1 year later; and the other is being treated for heart disease. The others have no serious respiratory problems. The stents in all have been in place for 1 to 25 (mean, 11) months. No immediate complications were noted. Early and late bronchoscopy showed incomplete epithelialization of the stent and patches of granulation tissue on it. Two stents were removed bronchoscopically, one at the completion of treatment for tracheomalacia and the other at the time of recurrent airway obstruction. This preliminary experience indicates that expandable metallic stents have a useful role in the treatment of selected lower airway obstructions.

Rupture of the Renal Artery After Cutting Balloon Angioplasty in a Young Woman With Fibromuscular Dysplasia

DOE Office of Scientific and Technical Information (OSTI.GOV)

Oguzkurt, Levent, E-mail: loguzkurt@yahoo.com; Tercan, Fahri; Gulcan, Oner

2005-04-15

A 24-year-old woman with uncontrollable high blood pressure for 3 months had significant stenosis of the left renal artery caused by fibromuscular dysplasia (FMD). The lesion was resistant to percutaneous transluminal angioplasty at 18 atm with a semicompliant balloon. Angioplasy with a 6 x 10 mm cutting balloon (CB) caused rupture of the artery. Low-pressure balloon inflation decreased but did not stop the leak. An attempt to place a stent-graft (Jostent; Jomed, Rangendingen, Germany) failed, and a bare, 6-mm balloon-expandable stent (Express SD; Boston Scientific, MN) was deployed to seal the leak, which had decreased considerably after long-duration balloon inflation.more » The bleeding continued, and the patient underwent emergent surgical revascularization of the renal artery with successful placement of a 6-mm polytetrafluoroethylene bypass graft. CBs should be used very carefully in the treatment of renal artery stenosis, particularly in patients with FMD.« less

Vascular occlusion with a balloon-expandable stent occluder.

PubMed

Moss, J G; Laborde, J C; Clem, M C; Rivera, F J; Encarnacion, C E; Meyer, K B; Palmaz, J C

1994-05-01

To evaluate the effectiveness of a new vascular occlusion device. The device was created by coating a balloon-expandable stent with a silicone sleeve that tapers to a blind-ended nozzle at its leading end. Once crimp-mounted on an angioplasty balloon catheter, the device is introduced over a guide wire through a small end hole in the nozzle. The device was tested for stability and occlusive ability. No migration was measured over a pulsatile pulse range of 50-300 mm Hg, and mean flow rate in the occluded vessel was reduced from 443 mL/min +/- 99 (standard deviation) to 1.9 mL/min +/- 2.7. Subsequently, 12 arteries were occluded in three dogs, and immediate vascular occlusion was achieved in all vessels. An arteriovenous fistula was created in another six dogs and was successfully occluded with the device. Follow-up arteriography at 3 months demonstrated persistent occlusion with no migration of the device. This new occlusive device offers immediate vascular occlusion with excellent stability.

A new idea for a safer approach to the supra-aortic trunks: the Piton™ catheter.

PubMed

Setacci, C; Moratto, R; Sirignano, P; Setacci, F; Silingardi, R; Coppi, G

2011-04-01

Carotid artery disease is among the most common causes of stroke, and stroke is the third leading cause of death in industrialized countries. Thus the personal health and socioeconomic burden of carotid artery disease is significant. Carotid artery disease accounts for approximately 5-12% of new strokes in patients amenable to revascularization therapy. Atherosclerosis is the main reason for stroke and accounts for approximately one third of all cases. Carotid stenting is nowadays considered a valid standard alternative to surgical carotid endarterectomy, especially in patients having a high perioperative risk. The first carotid balloon angioplasty was carried out in 1979 and the first carotid balloon-expandable bare metal stents were implanted 10 years later, in 1989. However, carotid stenting at that time was associated with major complications, due to extrinsic compression and subsequent to the steel stents used. The Piton™ GC (carotid guide catheter) is intended to facilitate the introduction and placement of interventional devices (e.g., guidewires, stent delivery systems, dilation balloons, angiographic- or micro-catheters, etc.) into the human vasculature to treat vascular obstructive disease, including but not limited to the supra-aortic vessels.

Predictors of outcomes in patients undergoing covered and uncovered self-expandable metal stent placement for malignant gastric outlet obstruction: a multicenter study.

PubMed

Hori, Yasuki; Naitoh, Itaru; Hayashi, Kazuki; Ban, Tesshin; Natsume, Makoto; Okumura, Fumihiro; Nakazawa, Takahiro; Takada, Hiroki; Hirano, Atsuyuki; Jinno, Naruomi; Togawa, Shozo; Ando, Tomoaki; Kataoka, Hiromi; Joh, Takashi

2017-02-01

Uncovered self-expandable metal stents (U-SEMSs) and covered self-expandable metal stents (C-SEMSs) are available for palliative therapy for malignant gastric outlet obstruction (GOO). However, clinical differences and indications between the 2 types of SEMSs have not been elucidated. We retrospectively compared 126 patients with U-SEMS and 126 patients with C-SEMSs with regard to clinical outcome and factors predictive of clinical improvement after SEMSs placement. No significant difference was observed between the U-SEMS and C-SEMS groups with respect to technical success, clinical success, GOO score, or time to stent dysfunction. Stent migration was significantly more frequent in patients with C-SEMSs (U-SEMSs, .79%; C-SEMSs, 8.73%; P = .005). Karnofsky performance status, chemotherapy, peritoneal dissemination, and stent expansion ≤ 30% were associated significantly with poor GOO score improvement in multivariable analyses, but stent type was not (P = .213). In subgroup analyses, insufficient (≤30%) stent expansion was an independent factor in patients with U-SEMSs (P = .041) but not C-SEMSs. In the insufficient stent expansion subgroup, C-SEMSs was associated significantly with superior clinical improvement compared with U-SEMSs (P = .01). Insufficient stent expansion was observed more frequently in patients with GI obstruction because of anastomotic sites or metastatic cancer (44.8% [13/29], P = .001). No clinical difference, apart from stent migration, was observed between patients with U-SEMSs and C-SEMSs. GI obstruction because of an anastomotic site or metastatic cancer may be an indication for C-SEMS use to improve oral intake after SEMSs placement. Copyright © 2017 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

Endoscopic removal of malfunctioning biliary self-expandable metallic stents.

PubMed

Familiari, Pietro; Bulajic, Milutin; Mutignani, Massimiliano; Lee, Linda S; Spera, Gianluca; Spada, Cristiano; Tringali, Andrea; Costamagna, Guido

2005-12-01

Endoscopic removal of malfunctioning self-expandable metallic biliary stents (SEMS) is difficult and not well described. The aim of this study is to review the indications, the techniques, and the results of SEMS removal in a cohort of patients with malfunctioning stents. All patients who underwent an attempt at endoscopic removal of biliary SEMS over a 5-year period were retrospectively identified. The main indications for SEMS removal were the following: distal migration of the stent or impaction to the duodenum, impaction into the bile-duct wall, tissue ingrowth, and inappropriate length of the stent causing occlusion of intrahepatic ducts. SEMS were removed by using foreign-body forceps or polypectomy snares. Endoscopic removal of 39 SEMS (13 uncovered and 26 covered) was attempted in 29 patients (17 men; mean age, 66 years). SEMS extraction was attempted after a mean of 7.5 months (8.75 months standard deviation) post-SEMS insertion. Removal was successful in 20 patients (68.9%) and in 29 SEMS (74.3%). Covered SEMS were effectively removed more frequently than uncovered ones: 24 of 26 (92.3%) and 5 of 13 (38.4%), respectively (p < 0.05). No major complications were recorded. Multivariate analysis showed that the time interval between insertion and removal, SEMS length, stent-mesh design (zigzag vs. interlaced), and indication for removal were not predictive of success at stent removal. Endoscopic removal of biliary SEMS is feasible and safe in more than 70% of cases. Because only 38% of uncovered SEMS were removable, the presence of a stent covering is the only factor predictive of successful stent extraction. The presence of diffuse and severe ingrowth was the main feature limiting SEMS removal.

Primary Self-EXPANDing Nitinol Stenting vs Balloon Angioplasty With Optional Bailout Stenting for the Treatment of Infrapopliteal Artery Disease in Patients With Severe Intermittent Claudication or Critical Limb Ischemia (EXPAND Study).

PubMed

Schulte, Karl-Ludwig; Pilger, Ernst; Schellong, Sebastian; Tan, Kong Ten; Baumann, Frederic; Langhoff, Ralf; Torsello, Giovanni; Zeller, Thomas; Amendt, Klaus; Brodmann, Marianne

2015-10-01

To compare primary placement of a self-expanding nitinol stent to percutaneous transluminal angioplasty (PTA) with bailout stenting in infrapopliteal arteries of patients with severe intermittent claudication or critical limb ischemia (CLI). In the EXPAND trial (ClinicalTrials.gov; identifier NCT00906022), 92 patients (mean age 72.9±9.5 years; 62 men) undergoing treatment for infrapopliteal stenosis in 11 European centers were randomized 1:1 to either self-expanding nitinol stenting with the Astron Pulsar/Pulsar-18 nitinol stent or PTA with bailout stenting. The primary endpoint was sustainable clinical improvement after 12 months, defined as a ≥1-category increase for Rutherford category 3 patients or a ≥2-category increase for CLI patients (Rutherford categories 4/5) compared with baseline. Furthermore, target lesion revascularization (TLR), mortality, and amputation were assessed after 12 months. Sustained clinical improvement at 1 year was observed in 74.3% of the patients treated with primary stenting and in 68.6% of the patients treated with PTA and bailout stenting (p>0.05). Kaplan-Meier estimates of freedom from TLR (76.6% and 77.6%), mortality (7.4% vs 2.1%), and amputation [8.9% (major 6.7%) vs 13.2% (major 8.7%)] at 1 year were not significantly different. Primary self-expanding nitinol stenting did not show statistically different clinical outcomes compared to angioplasty with bailout stenting for infrapopliteal lesions. © The Author(s) 2015.

An Update to Hepatobiliary Stents

PubMed Central

Moy, Brian T.; Birk, John W.

2015-01-01

Endoscopic stent placement is a common primary management therapy for benign and malignant biliary strictures. However, continuous use of stents is limited by occlusion and migration. Stent technology has evolved significantly over the past two decades to reduce these problems. The purpose of this article is to review current guidelines in managing malignant and benign biliary obstructions, current endoscopic techniques for stent placement, and emerging stent technology. What began as a simple plastic stent technology has evolved significantly to include uncovered, partially covered, and fully covered self-expanding metal stents (SEMS) as well as magnetic, bioabsorbable, drug-eluting, and antireflux stents.1 PMID:26357636

Endoscopic Treatment of Biliary Stenosis in Patients with Alveolar Echinococcosis--Report of 7 Consecutive Patients with Serial ERC Approach.

PubMed

Stojkovic, Marija; Junghanss, Thomas; Veeser, Mira; Weber, Tim F; Sauer, Peter

2016-02-01

Biliary vessel pathology due to alveolar echicococcosis (AE) results in variable combinations of stenosis, necrosis and inflammation. Modern management strategies for patients with cholestasis are desperately needed. The aim is proof of principle of serial ERC (endoscopic retrograde cholangiography) balloon dilation for AE biliary pathology. Retrospective case series of seven consecutive patients with AE-associated biliary pathology and ERC treatment in an interdisciplinary endoscopy unit at a University Hospital which hosts a national echinococcosis treatment center. The AE patient cohort consists of 106 patients with AE of the liver of which 13 presented with cholestasis. 6/13 received bilio-digestive anastomosis and 7/13 patients were treated by ERC and are reported here. Biliary stricture balloon dilation was performed with 18-Fr balloons at the initial and with 24-Fr balloons at subsequent interventions. If indicated 10 Fr plastic stents were placed. Six patients were treated by repeated balloon dilation and stenting, one by stenting only. After an acute phase of 6 months with repeated balloon dilation, three patients showed "sustained clinical success" and four patients "assisted therapeutic success," of which one has not yet reached the six month endpoint. In one patient, sustained success could not be achieved despite repeated insertion of plastic stents and balloon dilation, but with temporary insertion of a fully covered self-expanding metal stent (FCSEMS). There was no loss to follow up. No major complications were observed. Serial endoscopic dilation is a standard tool in the treatment of benign biliary strictures. Serial endoscopic intervention with balloon dilation combined with benzimidazole treatment can re-establish and maintain biliary duct patency in AE associated pathology and probably contributes to avoid or postpone bilio-digestive anastomosis. This approach is in accordance with current ERC guidelines and is minimally disruptive for patients.

Endoscopic Treatment of Biliary Stenosis in Patients with Alveolar Echinococcosis – Report of 7 Consecutive Patients with Serial ERC Approach

PubMed Central

Stojkovic, Marija; Junghanss, Thomas; Veeser, Mira; Weber, Tim F.; Sauer, Peter

2016-01-01

Background and Aims Biliary vessel pathology due to alveolar echicococcosis (AE) results in variable combinations of stenosis, necrosis and inflammation. Modern management strategies for patients with cholestasis are desperately needed. The aim is proof of principle of serial ERC (endoscopic retrograde cholangiography) balloon dilation for AE biliary pathology. Methods Retrospective case series of seven consecutive patients with AE-associated biliary pathology and ERC treatment in an interdisciplinary endoscopy unit at a University Hospital which hosts a national echinococcosis treatment center. The AE patient cohort consists of 106 patients with AE of the liver of which 13 presented with cholestasis. 6/13 received bilio-digestive anastomosis and 7/13 patients were treated by ERC and are reported here. Biliary stricture balloon dilation was performed with 18-Fr balloons at the initial and with 24-Fr balloons at subsequent interventions. If indicated 10 Fr plastic stents were placed. Results Six patients were treated by repeated balloon dilation and stenting, one by stenting only. After an acute phase of 6 months with repeated balloon dilation, three patients showed “sustained clinical success” and four patients “assisted therapeutic success,” of which one has not yet reached the six month endpoint. In one patient, sustained success could not be achieved despite repeated insertion of plastic stents and balloon dilation, but with temporary insertion of a fully covered self-expanding metal stent (FCSEMS). There was no loss to follow up. No major complications were observed. Conclusions Serial endoscopic dilation is a standard tool in the treatment of benign biliary strictures. Serial endoscopic intervention with balloon dilation combined with benzimidazole treatment can re-establish and maintain biliary duct patency in AE associated pathology and probably contributes to avoid or postpone bilio-digestive anastomosis. This approach is in accordance with current ERC guidelines and is minimally disruptive for patients. PMID:26910822

Percutaneous unilateral biliary metallic stent placement in patients with malignant obstruction of the biliary hila and contralateral portal vein steno-occlusion.

PubMed

Son, Rak Chae; Gwon, Dong Il; Ko, Heung Kyu; Kim, Jong Woo; Ko, Gi-Young

2015-01-01

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. 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. 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). 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.

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

PubMed Central

Son, Rak Chae; Ko, Heung Kyu; Kim, Jong Woo; Ko, Gi-Young

2015-01-01

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. PMID:25995688

Current Status of Interventional Radiology Treatment of Infrapopliteal Arterial Disease

DOE Office of Scientific and Technical Information (OSTI.GOV)

Rand, T., E-mail: thomas.rand@wienkav.at; Uberoi, R.

2013-06-15

Treatment of infrapopliteal arteries has developed to a standard technique during the past two decades. With the introduction of innovative devices, a variety of techniques has been created and is still under investigation. Treatment options range from plain balloon angioplasty (POBA), all sorts of stent applications, such as bare metal, balloon expanding, self-expanding, coated and drug-eluting stents, and bio-absorbable stents, to latest developments, such as drug-eluting balloons. Regarding the scientific background, several prospective, randomized studies with relevant numbers of patients have been (or will be) published that are Level I evidence. In contrast to older studies, which primarily were basedmore » mostly on numeric parameters, such as diameters or residual stenoses, more recent study concepts focus increasingly on clinical features, such as amputation rate improvement or changes of clinical stages and quality of life standards. Although it is still not decided, which of the individual techniques might be the best one, we can definitely conclude that whatever treatment of infrapopliteal arteries will be used it is of substantial benefit for the patient. Therefore, the goal of this review is to give an overview about the current developments and techniques for the treatment of infrapopliteal arteries, to present clinical and technical results, to weigh individual techniques, and to discuss the recent developments.« less

Role of fully covered self-expandable metal stent for treatment of benign biliary strictures and bile leaks.

PubMed

Pausawasadi, Nonthalee; Soontornmanokul, Tanassanee; Rerknimitr, Rungsun

2012-01-01

Endoscopic therapy by balloon dilation and placement of multiple large-bore plastic stents is the treatment of choice for benign biliary stricture. This approach is effective but it typically requires multiple endoscopic sessions given the short duration of stent patency. The endoscopic approach for treatment of bile leak involves the placement of a stent with or without biliary sphincterotomy. The self-expandable metal stent (SEMS) has traditionally been used for palliation of malignant biliary strictures given the long duration of stent patency owing to their larger stent diameter. Recently, SEMS has been used in a variety of benign biliary strictures and leaks, especially with the design of the covered self-expandable metal stent (CSEMS), which permits endoscopic-mediated stent removal. The use of CSEMS in benign biliary stricture could potentially result in a decrease in endoscopic sessions and it is technically easier when compared to placement of multiple plastic stents. However, complications such as cholecystitis due to blockage of cystic duct, stent migration, infection and pancreatitis have been reported. The potential subsegmental occlusion of contralateral intrahepatic ducts also limits the use of CSEMS in hilar stricture. Certain techniques and improvement of stent design may overcome these challenges in the future. Thus, CSEMS may be appropriate in only highly selected conditions, such as refractory benign biliary stricture, despite multiple plastic stent placement or difficult to treat bile duct stricture from chronic pancreatitis, and should not be used routinely. This review focuses on the use of fully covered self-expandable metal stent for benign biliary strictures and bile leaks.

Role of Fully Covered Self-Expandable Metal Stent for Treatment of Benign Biliary Strictures and Bile Leaks

PubMed Central

Pausawasadi, Nonthalee; Soontornmanokul, Tanassanee

2012-01-01

Endoscopic therapy by balloon dilation and placement of multiple large-bore plastic stents is the treatment of choice for benign biliary stricture. This approach is effective but it typically requires multiple endoscopic sessions given the short duration of stent patency. The endoscopic approach for treatment of bile leak involves the placement of a stent with or without biliary sphincterotomy. The self-expandable metal stent (SEMS) has traditionally been used for palliation of malignant biliary strictures given the long duration of stent patency owing to their larger stent diameter. Recently, SEMS has been used in a variety of benign biliary strictures and leaks, especially with the design of the covered self-expandable metal stent (CSEMS), which permits endoscopic-mediated stent removal. The use of CSEMS in benign biliary stricture could potentially result in a decrease in endoscopic sessions and it is technically easier when compared to placement of multiple plastic stents. However, complications such as cholecystitis due to blockage of cystic duct, stent migration, infection and pancreatitis have been reported. The potential subsegmental occlusion of contralateral intrahepatic ducts also limits the use of CSEMS in hilar stricture. Certain techniques and improvement of stent design may overcome these challenges in the future. Thus, CSEMS may be appropriate in only highly selected conditions, such as refractory benign biliary stricture, despite multiple plastic stent placement or difficult to treat bile duct stricture from chronic pancreatitis, and should not be used routinely. This review focuses on the use of fully covered self-expandable metal stent for benign biliary strictures and bile leaks. PMID:22563290

Biliary sphincteroplasty facilitates retrieval of proximally migrated plastic biliary stent.

PubMed

Shah, Dharmesh K; Jain, Samit S; Somani, Piyush O; Rathi, Pravin M

2014-01-01

Proximal migration of biliary stents presents a technical challenge for the therapeutic endoscopist. It may require multiple, complicated corrective procedures resulting in significant morbidity to the patients. In this study we evaluated the utility of balloon biliary sphincteroplasty with CRE (Controlled Radial Expansion) Balloon Dilator on retrieval of proximally migrated biliary stents. We identified patients from our ERCP database who presented with proximal migration of biliary stent, between August 2011 and October 2013. Patients in whom the stent could not be retrieved with conventional methods, balloon sphincteroplasty was performed with a 12 mm CRETM Balloon Dilator (Boston Scientific). Stent removal was attempted with extraction balloon or basket thereafter. We identified 28 patients with proximal migration of biliary stents, placed for benign diseases of the common bile duct. Stent removal was successful in 18 patients (64.28%) with help of an extraction balloon or basket. Of the remaining 10 patients, balloon sphincteroplasty was successfully followed by stent removal in eight patients. Balloon biliary sphincteroplasty increases the success rate of retrieving proximally migrated biliary stents. The procedure is safe, technically easy and yields a good success rate in our experience.

[Brief history of interventional radiology].

PubMed

Tang, Zhenliang; Jia, Aiqin; Li, Luoyun; Li, Chunyu

2014-05-01

In 1923, angiography was first successively used for the human body. In 1953, a Swedish doctor Sven-Ivar Seldinger pioneered the Seldinger technique, which laid down the foundation of interventional radiology. In 1963, Charles Dotter first proposed the idea of interventional radiology. In 1964, Charles Dotter opened a new era of percutaneous angioplasty through accidental operation, marking the formation of interventional radiology. On this basis, the techniques of balloon catheter dilation and metal stent implantation was developed. Endovascular stent was proposed in 1969. In 1973, the percutaneous angioplasty has been a breakthrough with the emergence of soft double-lumen balloon catheter. Percutaneous coronary angioplasty is applied in 1977. Since the 1990s, balloon angioplasty relegated to secondary status with the emergence of metal stent. Currently, endovascular stent have entered a new stage with the emergence of temporary stent and stent grafts and biological stent. Transcatheter arterial embolization had been one of the most important basic techniques for interventional radiology since 1965, it had also been a corresponding development with the improvement of embolic agents and catheter technology for the treatment of diseases now. Transjugular intrahepatic portosystemic stent-shunt is a comprehensive interventional radiology technology since 1967, in which the biliary system can be reached through a jugular vein, and the improvement appeared with balloon expandable stent in 1986.Since 1972, non-vascular interventional techniques was another important branch of interventional radiology. Currently, it is applied in the diagnosis and treatment of many diseases of the internal organs like the pancreas, liver, kidney, spinal cord, Fallopian tubes, esophagus and other organs. In 1973, Chinese radiologist first conducted the angiography test. Interventional radiology was introduced into China in the 1980s, it was readily developed through the sponsoring of training class (1981) and academic conferences (1986). Along with the return of the overseas scholars, the gap in the interventional diagnosis and treatment technology between China and the world has been narrowing since the 1990s.

Fatal complication from a balloon-expandable tracheal stent in a child: a case report.

PubMed

Stotz, William H; Berkowitz, Ivor D; Hoehner, Jeff C; Tunkel, David E

2003-01-01

The use of airway stents in the pediatric population is uncommon, reflected in the few patient series reported in the literature. We describe a fatal complication of tracheal stent placement in an 18-month-old child with spondylothoracic dysplasia. Case report. Intensive care unit of a tertiary academic pediatric center. An 18-month-old child with spondylothoracic dysplasia who underwent tracheal stent placement for tracheomalacia. Management of an acute upper-airway hemorrhage. The patient died, despite aggressive interventions. Use of tracheal stents in pediatric patients with tracheomalacia is not without risks; tracheal erosion with severe hemoptysis is an infrequent but devastating complication of this intervention.

[Treatment of a postoperative rectal stenosis with a self-expanding biodegradable polydioxanone stent].

PubMed

Dederichs, F; Knüdeler, S; Nolte, W; Iesalnieks, I

2013-05-01

Rectal stricture is a serious although infrequent complication of transanal endoscopic microsurgery (TEM). In some cases, these strictures may be refractory to treatment by endoscopic balloon dilatation. Biodegradable stents might improve the outcome by providing an extended period of dilatation. Moreover, these stents can remain in place without the need to remove them. In the presented case, a biodegradable polidioxanone stent originally developed to treat benign oesophageal stenoses was used to treat a patient suffering from rectal stricture following a TEM. © Georg Thieme Verlag KG Stuttgart · New York.

Endoscopic management of unresectable malignant gastroduodenal obstruction with a nitinol uncovered metal stent: A prospective Japanese multicenter study

PubMed Central

Sasaki, Reina; Sakai, Yuji; Tsuyuguchi, Toshio; Nishikawa, Takao; Fujimoto, Tatsuya; Mikami, Shigeru; Sugiyama, Harutoshi; Yokosuka, Osamu

2016-01-01

AIM: To determine the safety and efficacy of endoscopic duodenal stent placement in patients with malignant gastric outlet obstruction. METHODS: This prospective, observational, multicenter study included 39 consecutive patients with malignant gastric outlet obstruction. All patients underwent endoscopic placement of a nitinol, uncovered, self-expandable metal stent. The primary outcome was clinical success at 2 wk after stent placement that was defined as improvement in the Gastric Outlet Obstruction Scoring System score relative to the baseline. RESULTS: Technical success was achieved in all duodenal stent procedures. Procedure-related complications occurred in 4 patients (10.3%) in the form of mild pneumonitis. No other morbidities or mortalities were observed. The clinical success rate was 92.3%. The mean survival period after stent placement was 103 d. The mean period of stent patency was 149 d and the patency remained acceptable for the survival period. Stent dysfunction occurred in 3 patients (7.7%) on account of tumor growth. CONCLUSION: Endoscopic management using duodenal stents for patients with incurable malignant gastric outlet obstruction is safe and improved patients’ quality of life. PMID:27076769

Self-Expanding Versus Balloon-Expandable Stents for Iliac Artery Occlusive Disease: The Randomized ICE Trial.

PubMed

Krankenberg, Hans; Zeller, Thomas; Ingwersen, Maja; Schmalstieg, Josefin; Gissler, Hans Martin; Nikol, Sigrid; Baumgartner, Iris; Diehm, Nicolas; Nickling, Estell; Müller-Hülsbeck, Stefan; Schmiedel, Rainer; Torsello, Giovanni; Hochholzer, Willibald; Stelzner, Christian; Brechtel, Klaus; Ito, Wulf; Kickuth, Ralph; Blessing, Erwin; Thieme, Marcus; Nakonieczny, Jaroslaw; Nolte, Thomas; Gareis, Ragnar; Boden, Harald; Sixt, Sebastian

2017-08-28

Atherosclerosis of iliac arteries is widespread. As inflow vessels, they are of great clinical significance and increasingly being treated by endovascular means. Most commonly, stents are implanted. So far, due to a lack of comparative data, no guideline recommendations on the preferable stent type, balloon-expandable stent (BE) or self-expanding stent (SE), have been issued. In this randomized, multicenter study, patients with moderate to severe claudication from common or external iliac artery occlusive disease were assigned 1:1 to either BE or SE. The primary endpoint was binary restenosis at 12 months as determined by duplex ultrasound. Key secondary endpoints were walking impairment, freedom from target lesion revascularization (TLR), hemodynamic success, target limb amputation, and all-cause death. Six hundred sixty patients with 660 lesions were enrolled at 18 German and Swiss sites over a period of 34 months; 24.8% of the patients had diabetes and 57.4% were current smokers. The common iliac artery was affected in 58.9%. One hundred nine (16.5%) lesions were totally occluded and 25.6% heavily calcified. Twelve-month incidence of restenosis was 6.1% after SE implantation and 14.9% after BE implantation (p = 0.006). Kaplan-Meier estimate of freedom from TLR was 97.2% and 93.6%, respectively (p = 0.042). There was no between-group difference in walking impairment, hemodynamic success, amputation rate, all-cause death, or periprocedural complications. The treatment of iliac artery occlusive disease with SE as compared with BE resulted in a lower 12-month restenosis rate and a significantly reduced TLR rate. No safety concerns arose in both groups. (Iliac, Common and External [ICE] Artery Stent Trial; NCT01305174). Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Covered Stent Grafts for Acquired Arterial Venous Fistulas: A Case Series.

PubMed

Sarac, Timur P; Vargas, Lina; Kashyap, Vikram; Cardella, Jonathan; Chaar, Cassius Ochoa

2018-01-01

Stent grafts have become the preferred method for treating abdominal aortic aneurysms (AAAs) but also have utility in treating other vasculopathies. In 2005, peripheral stent grafts were approved for treating superficial femoral artery occlusive disease. This report describes our experience using covered stent grafts to treat acquired arterial venous fistulae (aAVF). We reviewed the records of patients treated for aAVF with covered stent grafts. Eleven patients had 12 limbs treated with a stent graft. The data collected included presenting symptoms, mechanism of injury, vessel location, stent graft used for therapy, and patency. Eleven patients underwent successful treatment of 12 aAVF with a peripheral stent grafts. The average age was 55.6 (18-87), and there were 4 women and 7 men. The mechanisms of injuries were heart catheterization in 5 patients, penetrating trauma in 3 patients, and orthopedic injury in 3 patients. Five of the patients had concurrent pseudoaneurysms. Self-expanding expanded polytetrafluoroethelene (ePTFE) stent grafts were used in 8 patients, and balloon-expandable ePTFE stent grafts were used in 3 patients. Primary patency at 2 years is 100%, with all patients having significant relief of symptoms. Peripheral stent grafts are a useful tool for treating aAVF, with excellent patency. They provide a valuable minimally invasive approach to this disease. Copyright © 2017 Elsevier Inc. All rights reserved.

Use of Self-Expanding Stents for the Treatment of Vertebral Artery Ostial Stenosis: a Single Center Experience

PubMed Central

Chung, Sun Young; Choi, Jin Woo; Choi, Byung Se; In, Hyun Sin; Kim, Sun Mi; Choi, Choong Gon; Kim, Sang Joon; Suh, Dae Chul

2010-01-01

Objective To evaluate our early experience using self-expanding stents to treat atherosclerotic vertebral artery ostial stenosis (VAOS), with respect to technical feasibility and clinical and imaging follow-up results. Materials and Methods A total of 20 lesions in 20 patients underwent stenting of the VAOS using a self-expanding stent (Precise RX; Cordis Neurovascular, Miami Lakes, FL). Two patients were asymptomatic. We analyzed the technical success rate, causes of technical failure, occurrence of any vascular or neurological event, and the occurrence of any neurological abnormality or in-stent restenosis (ISR) seen on follow-up. The imaging follow-up was performed with Doppler ultrasound (DUS) as a primary screening modality. Results One instance of technical failure was caused by failure of the guidewire passage. The stent diameter was 5 mm, and post-stenting balloon dilatations were necessary in all cases. Stent misplacement requiring placement of an additional stent occurred in four cases. Following a 14.8 month average clinical follow-up time, two patients showed anterior circulation ischemia, which was not attributed to the VAOS we treated. Following a 13.7 month average DUS follow-up, five patients showed a mild degree of diffuse or focal intimal thickening in the stent lumen; however, none of the stenosis showed luminal loss of more than 50% and no stent fracture was noted. Conclusion The use of self-expanding stents for treating VAOS was technically feasible and helped to improve artery patency during our limited follow-up interval. PMID:20191062

Usefulness of Corsair microcatheter to cross stent struts in bifurcation lesions.

PubMed

Fujimoto, Yoshihide; Iwata, Yo; Yamamoto, Masashi; Kobayashi, Yoshio

2014-01-01

Side branch compromise after stenting in bifurcation lesions is a matter of concern. It may happen that even low-profile balloon catheters do not cross stent struts after rewiring. The Corsair catheter is a hybrid catheter that has features of a microcatheter and a support catheter. The present study evaluated usefulness of the Corsair catheter to facilitate advancing a low-profile balloon catheter through stent struts in bifurcation lesions. After rewiring, low-profile balloon catheters failed to cross stent struts of 29 bifurcation lesions. The Corsair microcatheter successfully crossed stent struts in all lesions except one (97 %) where a stent was implanted to treat in-stent restenosis (stent-in-stent). Low-profile balloon catheters were able to advance into the side branch of all bifurcation lesions where the Corsair microcatheter crossed stent struts. In conclusion, the Corsair microcatheter may be utilized if low-profile balloon catheters are unable to cross stent struts in bifurcation lesions.

Evaluation of balloon withdrawal forces with bare-metal stents, compared with Taxus and Cypher drug-eluting coronary stents: balloon, stent and polymer interactions.

PubMed

Turk, Marvee; Gupta, Vishal; Fischell, Tim A

2010-03-01

There have been reports of serious complications related to difficulty removing the deflated Taxus stent delivery balloon after stent deployment. The purpose of this study was to determine whether the Taxus SIBS polymer was "sticky" and associated with an increase in the force required to remove the stent delivery balloon after stent deployment, using a quantitative, ex-vivo model. Balloon-polymer-stent interactions during balloon withdrawal were measured with the Taxus Liberté, Liberté bare-metal stent (BMS; no polymer = control), the Cordis Cypher drug-eluting stent (DES; PEVA/PBMA polymer) and the BX Velocity (no polymer). We quantitatively measured the force required to remove the deflated stent delivery balloon from each of these stents in simulated vessels at 37 degrees C in a water bath. Balloon withdrawal forces were measured in straight (0 degree curve), mildly curved (20 degree curve) and moderately curved (40 degree curve) simulated vessel segments. The average peak force required to remove the deflated balloon catheter from the Taxus Liberté DES, the Liberté BMS, the Cypher DES, and the Bx Velocity BMS were similar in straight segments, but were much greater for the Taxus Liberté in the moderately curved segments (1.4 lbs vs. 0.11 lbs, 0.11 lbs and 0.12 lbs, respectively; p < 0.0001). The SIBS polymer of the Taxus Liberté DES appears to be "sticky" and is associated with high forces required to withdraw the deflated balloon from the deployed stent in curved segments. This withdrawal issue may help to explain the clinical complications that have been reported with this device.

Palliative self-expandable metal stents for acute malignant colorectal obstruction: clinical outcomes and risk factors for complications.

PubMed

Han, Jae Pil; Hong, Su Jin; Kim, Shin Hee; Choi, Jong Hyo; Jung, Hee Jae; Cho, Youn Hee; Ko, Bong Min; Lee, Moon Sung

2014-08-01

Self-expandable metal stents (SEMSs) have been used as palliative treatment or bridge to surgery for obstructions caused by colorectal cancer (CRC). We assessed the long-term outcomes of palliative SEMSs and evaluated the risk factors influencing complications. One hundred and seventy-five patients underwent SEMS placement for acute malignant colorectal obstruction. Of the 72 patients who underwent palliative treatment for primary CRC, 30 patients received chemotherapy (CT) for primary cancer (CT group) and 42 underwent best supportive treatment (BST) without CT (BST group). There was a significant difference in late migration between the CT group and the BST group (20.0% in CT group, 2.4% in BST group, p = 0.018). Response to CT influenced the rate of late obstruction (0% in disease control, 35.7% in disease progression, p = 0.014). However, late obstruction was not associated with stent properties, such as diameter or type (≤22 mm vs. >22 mm, 13.5% vs. 14.3%, p = 1.00; uncovered stent vs. covered stent, 15.5% vs. 7.1%, p = 0.675) and migration (≤22 mm vs. >22 mm, 16.2% vs. 2.9%, p = 0.108; uncovered stent vs. covered stent, 8.6% vs. 14.3%, p = 0.615) in palliative SEMS. The administration of CT increases the rate of stent migration, and disease control by CT can reduce the risk of obstruction by maintaining the luminal patency of palliative SEMSs.

Feasibility of real-time magnetic resonance-guided angioplasty and stenting of renal arteries in vitro and in Swine, using a new polyetheretherketone-based magnetic resonance-compatible guidewire.

PubMed

Kos, Sebastian; Huegli, Rolf; Hofmann, Eugen; Quick, Harald H; Kuehl, Hilmar; Aker, Stephanie; Kaiser, Gernot M; Borm, Paul J; Jacob, Augustinus L; Bilecen, Deniz

2009-04-01

Demonstrate the usability of a new polyetheretherketone (PEEK)-based MR-compatible guidewire for renal artery catheterization, angioplasty, and stenting under MR-guidance using MR-visible markers, in vitro and in vivo. The new 0.035'' guidewire with fiber-reinforced PEEK core, a soft tip, and a hydrophilic coating was used. Paramagnetic markings were coated on the wire and nonbraided catheters for passive visualization. Bending stiffness of the guidewire was compared with available hydrophilic guidewires (Terumo Glidewire Stiff and Standard). A human aortic silicon phantom and 2 pigs were used. The study was animal care and use approved by the committee. Under MR-guidance, renal arteries were catheterized, balloon angioplasty was performed, and balloon expandable renal artery stents were deployed in vivo. Post mortem autopsy was performed. Guidewire visibility, pushability, steerability, and device-support capabilities of the marked guidewire were qualitatively assessed. Procedure times were recorded. Bending stiffness of the new PEEK-based wire was comparable with Standard Glidewire. In vitro and in vivo guidewire guidance, catheter configuration, renal artery catheterization, and balloon angioplasty were successful. In pigs, stent deployments were successful in both renal arteries. Autopsy revealed acceptable stent positioning. Guidewire visibility through applied markers was acceptable. Steerability, pushability, and device support were good in vitro and in vivo. The PEEK-based guide allows percutaneous MR-guided renal artery angioplasty and stenting with sufficient visibility, good steerability, pushability, and device support.

Expert Opinion: Optimising Stent Deployment in Contemporary Practice: The Role of Intracoronary Imaging and Non-compliant Balloons.

PubMed

Seth, Ashok; Gupta, Sajal; Pratap Singh, Vivudh; Kumar, Vijay

2017-09-01

Final stent dimensions remain an important predictor of restenosis, target vessel revascularisation (TVR) and subacute stent thrombosis (ST), even in the drug-eluting stent (DES) era. Stent balloons are usually semi-compliant and thus even high-pressure inflation may not achieve uniform or optimal stent expansion. Post-dilatation with non-compliant (NC) balloons after stent deployment has been shown to enhance stent expansion and could reduce TVR and ST. Based on supporting evidence and in the absence of large prospective randomised outcome-based trials, post-dilatation with an NC balloon to achieve optimal stent expansion and maximal luminal area is a logical technical recommendation, particularly in complex lesion subsets.

Clinical outcomes, quality of life, advantages and disadvantages of metal stent placement in the upper gastrointestinal tract.

PubMed

Vlavianos, Panagiotis; Zabron, Abigail

2012-03-01

This review will discuss the immediate- and long-term success, complications and overall benefits of self-expandable metal stents (SEMSs) in malignant or benign obstruction of the oesophagus, stomach and duodenum. Over recent years, indications such as benign disease have expanded, as has SEMS diversity with self-expandable plastic stents (SEPSs) or fully covered and biodegradable stents, for example. SEMSs have been increasingly used in malignant upper gastrointestinal obstruction with many reports confirming efficacy, despite a significant complication rate. Fully covered stents are increasingly used for a variety of benign oesophageal disease, but their place in gastric outlet obstruction is still unclear. Covered and uncovered stents have different functional characteristics and stent type must be selected on an individual basis. Biodegradable stents show promise and the outcome of experience in larger patient cohorts is eagerly awaited. This area is an evolving field, in which the clinician requires up-to-date knowledge of therapeutic options to make individualized treatment choices in difficult clinical circumstances. Technical and clinical success for oesophageal or gastroduodenal SEMSs are then above 90%. Minor complications are common, but serious complications seldom occur. Biodegradable stents may be useful, especially when stenting is needed for a short period of time.

Endoscopic approach for management of biliary strictures in liver transplant recipients: A systematic review and meta-analysis

PubMed Central

Aparício, Dayse Pereira da Silva; Otoch, José Pinhata; Montero, Edna Frasson de Souza; Artifon, Everson Luiz de Almeida

2016-01-01

The most common biliary complication after liver transplantation is anastomotic stricture (AS) and it can occur isolated or in combination with other complications. Liver graft from a cadaveric donor or a living donor has an influence on the incidence of biliary strictures as well as on the response to endoscopic treatment. Endoscopic treatment using balloon dilation and insertion of biliary stents by endoscopic retrograde cholangiopancreatography (ERCP) is the initial approach to these complications. Aim The aim of this article is to compare different endoscopic techniques to treat post-liver transplantation biliary strictures. Methods The search was carried out on MEDLINE, EMBASE, Scielo-LILACS and Cochrane Library databases through June 2015. A total of 1100 articles were retrieved. Ten clinical trials were analyzed, and seven were included in the meta-analysis. Conclusions The endoscopic treatment of AS was equally effective when compared the use of fully covered self-expandable metal stents (FCSEMS) vs. plastic stents, but the use of FCSEMS was associated with a lower complication risk. The treatment of AS with balloon dilation or balloon dilation associated with plastic stents presented similar results. Deceased donor liver transplantation reduced the risk of biliary stenosis and the endoscopic treatment in these patients was more effective when compared with Living donor liver transplantation. PMID:29026597

Short-Term Use of Uncovered Self-Expanding Metallic Airway Stents for Severe Expiratory Central Airway Collapse.

PubMed

Majid, Adnan; Alape, Daniel; Kheir, Fayez; Folch, Erik; Ochoa, Sebastian; Folch, Alejandro; Gangadharan, Sidhu P

2016-01-01

Patients with severe symptomatic expiratory central airway collapse (ECAC) undergo a stent trial to determine whether they are candidate for tracheobronchoplasty. Most stent trials were done using silicone stents. However, there was a higher number of silicone stent-related complications. The aim of this study was to evaluate the safety and efficacy of short-term uncovered self-expanding metallic airway stents (USEMAS) in patients with ECAC. This was a retrospective review. Baseline measurements were compared to those obtained after 7-14 days. Measurements included: Modified Medical Research Council (mMRC), Cough Quality of Life Questionnaire (CQLQ), spirometry testing, and 6-Minute Walk Test (6MWT). Stent- and procedure-related complications were reported. 33 patients (median age, 52 years) underwent the USEMAS trial. Presenting symptoms were dyspnea in 100%, intractable cough in 90.3%, recurrent infection in 42.2%, and inability to clear secretions in 21.4%. Dyspnea, cough, and secretion clearance improved in 88, 70, and 57%, respectively. Overall, there was a significant improvement in mMRC (p < 0.001), CQLQ (p = 0.015), and 6MWT (p = 0.015). There was 1 airway infection, 1 stent migration, and 1 pneumothorax. The median duration of USEMAS was 7 days. All stents were removed without any complications. At the time of stent removal, no granulation tissue was observed in 30.9%, and mild granulation tissue was observed in 69.1%. The short-term USEMAS trial improves respiratory symptoms, quality of life, and exercise capacity with few complications in patients with severe symptomatic ECAC when performed by a multidisciplinary airway team in highly specialized centers with experience in the evaluation and treatment of this patient population. © 2016 S. Karger AG, Basel.

Mechanical Interaction of an Expanding Coiled Stent with a Plaque-Containing Arterial Wall: A Finite Element Analysis.

PubMed

Welch, Tré R; Eberhart, Robert C; Banerjee, Subhash; Chuong, Cheng-Jen

2016-03-01

Wall injury is observed during stent expansion within atherosclerotic arteries, related in part to stimulation of the inflammatory process. Wall stress and strain induced by stent expansion can be closely examined by finite element analysis (FEA), thus shedding light on procedure-induced sources of inflammation. The purpose of this work was to use FEA to examine the interaction of a coiled polymer stent with a plaque-containing arterial wall during stent expansion. An asymmetric fibrotic plaque-containing arterial wall model was created from intravascular ultrasound (IVUS) images of a diseased artery. A 3D model for a coil stent at unexpanded state was generated in SolidWorks. They were imported into ANSYS for FEA of combined stent expansion and fibrotic plaque-distortion. We simulated the stent expansion in the plaqued lumen by increasing balloon pressure from 0 to 12 atm in 1 atm step. At increasing pressure, we examined how the expanding stent exerts forces on the fibrotic plaque and vascular wall components, and how the latter collectively resist and balance the expansive forces from the stent. Results show the expanding coiled stent creates high stresses within the plaque and the surrounding fibrotic capsule. Lower stresses were observed in adjacent medial and adventitial layers. High principal strains were observed in plaque and fibrotic capsule. The results suggest fibrotic capsule rupture might occur at localized regions. The FEA/IVUS method can be adapted for routine examination of the effects of the expansion of selected furled stents against IVUS-reconstructed diseased vessels, to improve stent deployment practices.

Design and modeling balloon-expandable coronary stent for manufacturability

NASA Astrophysics Data System (ADS)

Suryawan, D.; Suyitno

2017-02-01

Coronary artery disease (CAD) is a disease that caused by narrowing of the coronary artery. The narrowing coronary artery is usually caused by cholesterol-containing deposit (plaque) which can cause a heart attack. CAD is the most common cause mortality in Indonesia. The commonly CAD treatment use the stent to opens or alleviate the narrowing coronary artery. In this study, the stent design is optimized for the manufacturability. Modeling is used to determine the free stent expansion due to applied pressure in the inner surface of the stent. The stress distribution, outer diameter change, and dogboning phenomena are investigated in the simulation. The result of modeling and simulating was analyzed and used to optimize the stent design before it is manufactured using EDM (Electric Discharge Machine) in the next research.

Stent-based nitric oxide delivery reducing neointimal proliferation in a porcine carotid overstretch injury model.

PubMed

Hou, Dongming; Narciso, Hugh; Kamdar, Kirti; Zhang, Ping; Barclay, Bruce; March, Keith L

2005-01-01

The effects of nitric acid (NO) on vessel response to injury include the inhibition of platelet adhesion, platelet aggregation, leukocyte adhesion and smooth muscle cell proliferation. Releasing NO from a stent might reduce the clinical problem of restenosis. The present study was designed to examine whether an NO-eluting covered stent can prevent neointimal formation in a porcine carotid overstretch injury model. The interior of a self-expanding polytetrafluoroethylene (ePTFE)-covered aSpire stent was coated with silicone, which contained 23.6 microg or 54.5 microg sodium nitroprusside (SNP, NO-releasing compound). The stent was implanted into carotid artery. Six pigs were implanted with stents, one high-dose SNP and one uncoated control, following balloon overstretch injury of the carotid artery with a balloon-to-artery ratio of 1.3:1. No local or systemic toxicity was evidenced in the six pigs after carotid artery implantation with either low- or high-dose stents within a week. At day 28, the mean intimal thickness was 0.12 +/- 0.05 mm for NO-eluting stents and 0.43 +/- 0.09 mm for uncoated stents (p = 0.008). The mean neointimal area was reduced from 2.40 +/- 0.39 mm2 for control stents to 0.49 +/- 0.16 mm2 for NO-eluting stents (p < 0.0001), which resulted in a 24% reduction of angiographic vessel narrowing. The NO-eluting ePTFE-covered stent is feasible and effectively reduces in-stent neointimal hyperplasia at 28 days in a porcine carotid overstretch model.

Flexible endoscopy for pediatric tracheobronchial metallic stent placement, maintenance and long-term outcomes

PubMed Central

2018-01-01

Objectives To assess the placement, surveillance management and long-term outcomes of the tracheobronchial (TB) balloon expandable metallic stent (BEMS) managed by therapeutic flexible endoscopy (TFE). Methods This is a retrospective review and analysis of all computerized medical records and related flexible endoscopy videos of pediatric patients who received TB BEMS during 20 years period, from January 1997 to December 2016. TFE techniques with forceps debridement, balloon dilatation and laser ablation were used to implant stents, perform regular surveillance, maintain their functions, and expand the diameters of BEMS. Short-length (30cm-36cm) endoscopes of OD 3.2mm to 5.0mm coupled with the noninvasive ventilation, without ventilation bag, mask or airway tube, supported the whole procedures. Results 146 BEMS were implanted in 87 consecutive children, including 84 tracheal, 15 carinal and 47 bronchial stents. At the time of placement, the mean age was 35.6 ± 54.6 month-old (range 0.3–228) and the mean body weight was 13.9 ± 10.6 kg (range 2.2–60). Surveillance period was 9.4 ± 6.7 years (range, 0.3–18.0). Satisfactory clinical improvements were noted immediately in all but two patients. Seventy-two (82.8%) patients were still alive with stable respiratory status, except two patients necessitating TFE management every two months. Fifty-one stents, including 35 tracheal and 16 bronchial ones, were successfully retrieved mainly with rigid endoscopy. Implanted stents could be significantly (< .001) further expanded for growing TB lumens. The final stent diameters were positively correlated to the implanted duration. Altogether, 33 stents expired (15 patients), 51 were retrieved (40 patients), and 62 remained and functioning well (38 patients), with their mean duration of 7.4 ± 9.5, 34.9 ± 36.3 and 82.3 ± 62.5 months, respectively. Conclusion In pediatric patients, TFE with short-length scopes coupled with this NIV support has provided a safe, feasible and effective modality in placing and subsequently managing TB BEMS with acceptable long-term outcomes. PMID:29420596

The glider balloon: a useful device for the treatment of bifurcation lesions.

PubMed

Briguori, Carlo; Visconti, Gabriella; Donahue, Michael; Chiariello, Giovanni Alfonso; Focaccio, Amelia

2013-10-09

Final kissing balloon dilatation (FKBD) is a recommended final step in case of treatment of bifurcation lesions by two stents approaches. Furthermore, dilatation of the side branch (SB) may be necessary following main vessel (MV) stenting. Occasionally, recrossing the stent struts with a balloon is hampered because the tip hits a stent strut. The Glider (TriReme Medical, Pleasanton, CA) is a dedicated balloon designed for crossing through struts of deployed stents toward a SB. From October 2010 to January 2012, FKBD was attempted in 236 consecutive bifurcation lesions treated in our Institution. FKBD was successfully performed by conventional balloon catheters in 221 (93.5%) lesions (Conventional group). In the remaining 15 (6.5%) lesions, where a conventional balloon failed to cross the stent strut, the Glider balloon was attempted (Glider group). The angle beta (between the axis of the MV after the branch point and the SB axis at the point of divergence) was wider in the Glider group (83±17° versus 65±27°; p=0.032). A trend toward an higher rate of the true bifurcation lesions was observed in the Glider group (93% versus 70.5%; p=0.07). The Glider balloon successfully crossed through MV stent struts toward a SB in 12 patients (80%), whereas failed in the remaining 3 patients. The Glider balloon represents an unique bail-out device which offers an effective rescue strategy for recrossing stent struts during complex bifurcation stenting. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Stent and leaflet stresses in a 26-mm first-generation balloon-expandable transcatheter aortic valve.

PubMed

Xuan, Yue; Krishnan, Kapil; Ye, Jian; Dvir, Danny; Guccione, Julius M; Ge, Liang; Tseng, Elaine E

2017-05-01

Transcatheter aortic valve replacement is established therapy for high-risk and inoperable patients with severe aortic stenosis, but questions remain regarding long-term durability. Valve design influences durability. Increased leaflet stresses in surgical bioprostheses have been correlated with degeneration; however, transcatheter valve leaflet stresses are unknown. From 2007 to 2014, a majority of US patients received first-generation balloon-expandable transcatheter valves. Our goal was to determine stent and leaflet stresses in this valve design using finite element analyses. A 26-mm Sapien Transcatheter Heart Valve (Edwards Lifesciences, Inc, Irvine, Calif) underwent high-resolution microcomputed tomography scanning to develop precise 3-dimensional geometry of the leaflets, the stent, and the polyethylene terephthalate elements. The stent was modeled using 3-dimensional elements and the leaflets were modeled using shell elements. Stent material properties were based on stainless steel, whereas those for leaflets were obtained from surgical bioprostheses. Noncylindrical Sapien valve geometry was also simulated. Pressure loading to 80 mm Hg and 120 mm Hg was performed using ABAQUS finite element software (Dassault Systèmes, Waltham, Mass). At 80 mm Hg, maximum principal stresses on Sapien leaflets were 1.31 megaspascals (MPa). Peak leaflet stress was observed at commissural tips where leaflets connected to the stent. Maximum principal stresses for the stent were 188.91 MPa and located at stent tips where leaflet commissures were attached. Noncylindrical geometry increased peak principal leaflet stresses by 16%. Using exact geometry from high-resolution scans, the 26-mm Sapien Transcatheter Heart Valve showed that peak stresses for both stent and leaflets were present at commissural tips where leaflets were attached. These regions would be prone to leaflet degeneration. Understanding stresses in first-generation transcatheter valves allows comparison to future designs for relative durability. Copyright © 2017 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

Comparison of the utility of covered metal stents versus uncovered metal stents in the management of malignant biliary strictures in 749 patients.

PubMed

Lee, Jeffrey H; Krishna, Somashekar G; Singh, Amanpal; Ladha, Harshad S; Slack, Rebecca S; Ramireddy, Srinivas; Raju, Gottumukkala S; Davila, Marta; Ross, William A

2013-08-01

Self-expandable metal stents (SEMSs) are used to relieve malignant biliary obstruction. To compare outcomes between covered self-expandable metal stents (CSEMSs) and uncovered self-expandable metal stents (USEMSs) in malignant biliary obstruction. Retrospective cohort study. Tertiary cancer center. Patients with malignant biliary obstruction. Placement of CSEMS or USEMS. Time to recurrent biliary obstruction (TRO), overall survival (OS), and adverse events. From January 2000 to June 2011, 749 patients received SEMSs: 171 CSEMSs and 578 USEMSs. At 1 year, there was no significant difference in the percentage of patients with recurrent obstruction (CSEMSs, 35% vs USEMSs, 38%) and survival (CSEMSs, 45% vs USEMSs, 49%). There was no significant difference in the median OS (CSEMSs, 10.4 months vs USEMSs, 11.8 months; P = .84) and the median TRO (CSEMSs, 15.4 months vs USEMSs, 26.3 months; P = .61). The adverse event rate was 27.5% for the CSEMS group and 27.7% for the USEMS group. Although tumor ingrowth with recurrent obstruction was more common in the USEMS group (76% vs 9%, P < .001), stent migration (36% vs 2%, P < .001) and acute pancreatitis (6% vs 1%, P < .001) were more common in the CSEMS group. Retrospective study. There was no significant difference in the patency rate or overall survival between CSEMSs and USEMSs for malignant distal biliary strictures. The CSEMS group had a significantly higher rate of migration and pancreatitis than the USEMS group. No significant SEMS-related adverse events were observed in patients undergoing neoadjuvant chemoradiation or surgical resection. Copyright © 2013 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

[Interventional catheter treatment of bypass graft stenosis: comparison of intracoronary stent implantation and balloon angioplasty].

PubMed

Heidland, U E; Heintzen, M P; Schoppmann, D; Michel, C J; Strauer, B E

2000-02-25

Balloon angioplasty of a stenosed bypass graft has a much higher risk of recurrent stenosis than dilatation of a stenosed native coronary artery. Intracoronary stent implantation has established itself as the better treatment of native coronary artery stenosis than conventional balloon angioplasty. However, there is still uncertainty whether intracoronary stent implantation in stenosed bypass vessels gives better long-term results than conventional balloon angioplasty. Results were retrospectively analyzed of unrandomized 224 primarily successful interventions--122 balloon dilatations and 102 stent implantations--performed between January 1996 and June 1998 on stenosed coronary bypass grafts, re-examined by coronary angiography an average of 6 months later. All but 11 patients were on combined aspirin and ticlopidine antiplatelet aggregation treatment. There was a significantly lower 6-month restenosis rate (30.4%) after stent implantation than after balloon dilatation (51.6%). The re-intervention rate was also significantly lower after stent implantation. These data suggest that stent implantation of stenosed coronary bypass grafts under cover of platelet-aggregation inhibition with aspirin and ticlopidine provides a lower restenosis and thus higher revascularization rate than conventional balloon dilatation.

Novel self-expandable, stent-based transcatheter pulmonic valve: a preclinical animal study.

PubMed

Kim, Gi Beom; Lim, Hong-Gook; Kim, Yong Jin; Choi, Eun Young; Kwon, Bo Sang; Jeong, Saeromi

2014-04-15

Because transcatheter implantation of pulmonary valve is indicated for limited-size dysfunctional right ventricular outflow tract only as a balloon-expandable stent, we investigated the feasibility of a large-diameter self-expandable valved stent and the durability of the valve after >6 months. We made a nitinol-wire-based, self-expandable valved stent with leaflets made from porcine pericardium. The porcine pericardium was treated with α-galactosidase, glutaraldehyde, and glycine after decellularization. After cutting the inguinal or cervical area, we implanted a valved stent in 12 sheep through the femoral or jugular vein by using an 18-Fr delivery catheter, controlling the catheter handles and hook block under fluoroscopic and echocardiographic guidance. The mean body weight of sheep was 43.9 kg. We successfully implanted valved stents (diameter: 24 mm in 7 sheep, 26 mm in 5 sheep) in good position in 8 sheep, in the main pulmonary artery (PA) in 2 sheep, and in the right ventricular outlet tract (RVOT) in 2 sheep. We sacrificed 8 sheep (6 sheep in good position, 1 sheep in the main PA, and 1 sheep in the RVOT) after >6 months. Five of the 6 sheep implanted in good position showed well-preserved valve morphology at the time of sacrifice. Histologic findings after routine sacrifice showed well-maintained collagen wave structure and no visible calcification in all explanted valve leaflets. Transcatheter implantation of a nitinol-wire-based, self-expandable valved stent in the pulmonic valve was feasible, and stents implanted in good position showed well-preserved valve leaflets with functional competence in the mid-term results. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Efficacy of a Self-Expandable Porous Stent as the Sole Curative Treatment for Extracranial Carotid Pseudoaneurysms.

PubMed

Chen, Peng Roc; Edwards, Nancy J; Sanzgiri, Aditya; Day, Arthur L

2016-04-01

Extracranial carotid pseudoaneurysms are uncommon vascular lesions. Even with conservative management complications can happen, such as delayed cerebral embolization or symptoms due to flow limitation. Although endovascular therapy can be curative, literature demonstrating a preferred technique is scant. Our goal was to evaluate the use of 1 technique only-the deployment of overlapping self-expandable porous stents-to treat a series of extracranial carotid pseudoaneurysms. From 2008 to 2014, 14 consecutive cases of symptomatic extracranial carotid pseudoaneurysms were managed with single or multilayer porous stents at our institution. Each patient underwent a standardized angiographic follow-up at 6 months. Twelve patients also received a follow-up computed tomography angiogram at 12 months, and yearly thereafter (median radiographic follow-up, 38 months). The total clinical follow-up period ranged between 6 and 69 months (median, 46 months). In our series, each of the extracranial carotid pseudoaneurysms appeared to be the result of carotid artery dissection with associated carotid stenosis at the origin of every pseudoaneurysm. Endovascular treatment consisted of 1-3 layers of self-expandable porous stents placed without balloon angioplasty. Immediately after stenting angiographic images were notable for stagnant opacification of the pseudoaneurysm through the stent(s). All pseudoaneurysms were completely obliterated by the 6-month follow-up angiogram and remained so throughout the radiographic follow-up period. Complications were minimal, consisting of 1 patient developing a mild Horner's syndrome after treatment that resolved during clinical follow-up. Extracranial carotid pseudoaneurysms can be successfully obliterated with the use of porous, self-expandable stents. Copyright © 2016 Elsevier Inc. All rights reserved.

Pneumoperitoneum Caused by Transhepatic Air Leak After Metallic Biliary Stent Placement

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lee, Jei Hee; Lee, Deok Hee; Yu, Jeong-Sik

2000-11-15

A self-expanding metallic biliary stent was placed for palliation of a common bile duct obstruction in a 68-year-old male with unresectable pancreatic head cancer 3 days after initial percutaneous right transhepatic catheter decompression. The stent crossed the ampulla of Vater. Three days later, the stent was balloon-dilated and the percutaneous access was removed. At removal, a small contrast leak from the transhepatic tract was seen. Three days later, pneumoperitoneum was found with symptoms of peritoneal irritation and fever. A widely open sphincter of Oddi caused by the metallic stent, accompanied by delayed sealing of the transhepatic tract, may have causedmore » the air and bile leakage into the peritoneal space. This case shows that pneumoperitoneum may occur without ductal tear or bowel injury, with a biliary stent crossing the ampulla of Vater.« less

Initial experience with the E-ventus® stent-graft for endovascular treatment of visceral artery aneurysms.

PubMed

Anton, Susanne; Stahlberg, Erik; Horn, Marco; Wiedner, Marcus; Kleemann, Markus; Barkhausen, Joerg; Goltz, Jan P

2018-04-01

To evaluate the safety and efficacy of a novel balloon-expandable stent-graft for endovascular treatment of visceral artery aneurysms (VAA). Between 9/2014 and 1/2017 seven patients (69±15 years) with true (N.=4) and false (N.=3) VAAs were treated by implantation of balloon-expandable stent-grafts (E-ventus®, Jotec, Hechingen, Germany) using a transfemoral (N.=2) or transbrachial (N.=5) vascular access. The stent-graft was placed without prior passing of the landing zone with a sheath. In 3 of 7 patients (42.9%) additional coil or plug embolization was performed to prevent retrograde VAA perfusion. Endpoints were technical success (defined as delivery and implantation of the stent-graft in the intended position with complete exclusion of the VAA), peri-procedural complications and patency. Mean diameters of true VAAs (splenic artery: N.=2, common hepatic artery: N.=1, celiac trunk: N.=1) were 26±9 and of false (common hepatic artery: N.=2, gastroduodenal artery: N.=1) 29±14 mm. False aneurysms presented as emergencies with active bleeding. Technical success was 100%. One peri-procedural complication was noted: pseudoaneurysm of the accessed brachial artery. After a mean follow-up of 187 days 6/7 stent-grafts (85.7%) were patent. One patient (fVAA) died two days after the emergency procedure owing to multi-organ failure which was assessed to be non-procedure-related. Another patient (fVAA) died 7 months from the procedure owing to cancer. Endovascular treatment of true and false visceral artery aneurysms by use of the E-ventus® stent-graft is safe and effective. Flexibility of the stent-graft and shaft allows for implantation without passing the lesion with a sheath, enabling treatment of distal as well as complex visceral lesions. Long-term results regarding patency in a larger patient cohort are needed to confirm these findings.

Percutaneous endovascular therapy for symptomatic chronic total occlusion of the left subclavian artery.

PubMed

Akif Cakar, Mehmet; Tatli, Ersun; Tokatli, Alptug; Kilic, Harun; Gunduz, Huseyin; Akdemir, Ramazan

2018-03-16

Percutaneous endovascular therapy is an accepted and preferred procedure for symptomatic subclavian artery disease. However, the technical feasibility and effectiveness of treating chronic total occlusion of the subclavian artery with this approach is uncertain. We aimed to evaluate the initial and mid-term results of endovascular therapy for patients with symptomatic chronic total occlusion of the left subclavian artery. Consecutive patients who underwent balloon angioplasty and stenting for chronic total occlusion of the left subclavian artery between January 2010 and February 2014 were included. Overall, 16 patients (10 male, 6 female; mean age 56 ± 13 years) underwent balloon angioplasty and stenting for chronic total occlusion of the left subclavian artery - 6 (37.5%) had arm claudication, 8 (50.0%) had vertebrobasilar insufficiency and 2 (12.5%) had coronary steal. 18 balloon-expandable stents were implanted to 15 patients. The central luminal passage was not achieved in one patient because of the subintimal position of guidewire (procedural success rate 93.8%). There were no procedure-related complications. Mean preprocedural and postprocedural systolic blood pressure differences between the upper extremities were 37 ± 13 (range 25-60) mmHg and 11 ± 9 (range 5-38) mmHg, respectively; the improvement was statistically significant. Outpatient follow-up revealed one asymptomatic restenosis at two years. Patency rate at two years was 93.3%. Balloon angioplasty and stenting for chronic total occlusion of the left subclavian artery is safe and effective, with good acute success rate and mid-term patency. Prospective randomised studies on larger patient populations would provide more precise results.

Rotational atherectomy ablation for an unexpandable stent under the guide of IVUS

PubMed Central

Si, Daoyuan; Liu, Guohui; Tong, Yaliang; He, Yuquan

2018-01-01

Abstract Rationale: Inadequate stent expansion due to rigid calcified may result in restenosis lesions, but the available options are limited. Patient concerns: We report a case via the trans-radial approach of the severely underexpanded freshly deployed stent due to heavily calcified plaques Diagnoses: Coronary angiography revealed that there was no adequate expansion of the freshly deployed stent. Interventions: Under the guide of intravascular ultrasound (IVUS), rotational atherectomy (RA) successfully ablated the stent layers and the protruding calcified plaque. Followed by balloon angioplasty, the ablated segment was scaffolded with another stent, well expanded and documented by IVUS. Outcomes: The patient was uneventful during the procedure and remained angina free at the point of one year of clinical follow-up. Lessons: This case indicated that RA via the trans-radial approach could be a useful remedy in the situation of under-expansion of implanted stents, and the debulking should be performed under IVUS-guidance. PMID:29443790

Immediate stent recoil in an anastomotic vein graft lesion treated by cutting balloon angioplasty.

PubMed

Akkus, Nuri Ilker; Budeepalli, Jagan; Cilingiroglu, Mehmet

2013-11-01

Saphenous vein graft (SVG) anastomotic lesions can have significant fibromuscular hyperplasia and may be resistant to balloon angioplasty alone. Stents have been used successfully to treat these lesions. There are no reports of immediate stent recoil following such treatment in the literature. We describe immediate and persistent stent recoil in an anastomotic SVG lesion even after initial and post-deployment complete balloon dilatation of the stent and its successful treatment by cutting balloon angioplasty. Copyright © 2013 Sociedade Portuguesa de Cardiologia. Published by Elsevier España. All rights reserved.

Endovascular Treatment of Iatrogenic and Traumatic Carotid Artery Dissection

DOE Office of Scientific and Technical Information (OSTI.GOV)

Schulte, Stefan; Donas, Konstantinos P., E-mail: k.donas@gmx.at; Pitoulias, Georgios A.

This paper reports on the early and midterm results of endovascular treatment of acute carotid artery dissections, its specific problems, and its limitations. We encountered seven patients with symptomatic extracranial carotid artery dissection, three cases of which occurred after carotid endarterectomy, two after carotid angioplasty and stenting, and two after trauma. Balloon-expandable and self-expanding stents were placed using a transfemoral approach. Success in restoring the carotid lumen was achieved in all patients. No procedure-related complications occurred. All patients experienced significant clinical improvement while in the hospital and achieved complete long-term recovery. At follow-up (mean, 22.4 months), good luminal patency ofmore » the stented segments was observed. In conclusion, in this small series, primary stent-supported angioplasty seems to be a safe and effective strategy in the treatment of selected patients having acute traumatic extracranial carotid artery dissection, with excellent early and midterm results. Larger series and longer-term follow-up are required before definitive recommendations can be made.« less

Single brand, fully-covered, self-expandable metal stent for the treatment of benign biliary disease: when should stents be removed?

PubMed

Mangiavillano, Benedetto; Khashab, Mouen A; Eusebi, Leonardo H; Tarantino, Ilaria; Bianchetti, Mario; Semeraro, Rossella; Pellicano, Rinaldo; Traina, Mario; Repici, Alessandro

2018-05-31

The two most relevant endoscopic treatable benign biliary diseases (BBD) are benign biliary strictures (BBSs) and biliary leaks (BLs), often associated with high morbidity. The most common endoscopic treatment for biliary strictures involves placement of multiple plastic stents (PSs), with or without balloon dilation, followed by planned exchange of the stents. Thus, there continues to be high interest in pursuing alternative endoscopic approaches that may achieve better results with fewer interventions. In this setting, the use of a fully-covered, self-expandable metal stent (FCSEMS) is an attractive alternative to single or multiple PSs for the treatment of BBDs. A single metal stent can remain in place for a longer period of time before removal; however, the maximum time the stent can be remain in place is still not well defined. The aim of this review is to determine the removal time of the TaeWoong® FCSEMS, placed for BBD. According to our data analysis, considering the absence of loss of the covering of the FCSEMS and of any adverse events during and after stent removal, leaving the TaeWoong medical FCSEMS in situ for an 8 months' period seems to be acceptable for benign biliary diseases. Further studies need to evaluate their removability at 1 year.

Treatment of Venous Aortorenal Bypass Graft Aneurysm Using a Stent-Graft

DOE Office of Scientific and Technical Information (OSTI.GOV)

Novotny, Jiri, E-mail: jino@medicon.cz; Peregrin, Jan H.; Stribrna, Jarmila

2010-02-15

We present the case of a 77-year-old male patient who had undergone a bilateral venous aortorenal bypass graft 30 years previously. Thirteen years previously, the patient was shown to have a decrease in renal function, with mild shrinking of both kidneys; additionally, a stenosis was found in the left proximal anastomosis. At the most recent follow-up visit (1 year previously), ultrasound revealed an aneurysm (42 mm in diameter) of the left renal bypass graft; the finding was confirmed by CT angiography. A significant ostial stenosis of the left renal bypass graft was also confirmed. It was decided to place amore » self-expandable stent-graft into the aneurysm while also attempting to dilate the stenosis. Proximal endoleak after stent-graft placement necessitated the implantation of another, balloon-expandable stent-graft into the bypass graft ostium. Postprocedural angiography and follow-up by CT angiography at 3 months confirmed good patency of the stent-grafts and complete thrombosis of the aneurysmal sac, with preserved kidney perfusion. Renal function remained unaltered, while the hypertension is better controlled.« less

Covered duodenal self-expandable metal stents prolong biliary stent patency in double stenting: The largest series of bilioduodenal obstruction.

PubMed

Hori, Yasuki; Naitoh, Itaru; Hayashi, Kazuki; Kondo, Hiromu; Yoshida, Michihiro; Shimizu, Shuya; Hirano, Atsuyuki; Okumura, Fumihiro; Ando, Tomoaki; Jinno, Naruomi; Takada, Hiroki; Togawa, Shozo; Joh, Takashi

2018-03-01

Endoscopic biliary and duodenal stenting (DS; double stenting) is widely accepted as a palliation therapy for malignant bilioduodenal obstruction. The aim of the current study was to investigate the patency and adverse events of duodenal and biliary stents in patients with DS. Patients who underwent DS from April 2004 to March 2017 were analyzed retrospectively with regard to clinical outcomes and predictive factors of recurrent biliary and duodenal obstruction (recurrent biliary obstruction [RBO] and recurrent duodenal obstruction [RDO]). A total of 109 consecutive patients was enrolled. Technical success of DS was achieved in 108 patients (99.1%). Symptoms due to biliary and duodenal obstruction were improved in 89 patients (81.7%). RBO occurred in 25 patients (22.9%) and RDO in 13 (11.9%). The median times to RBO and RDO from DS were 87 and 76 days, respectively. Placement of a duodenal uncovered self-expandable metal stent (U-SEMS) was significantly associated with RBO in the multivariable analysis (P = 0.007). Time to RBO was significantly longer in the duodenal covered self-expandable metal stent group than in the U-SEMS group (P = 0.003). No predictive factors of RDO were detected, and duodenal stent type was not associated with the time to RDO (P = 0.724). Double stenting was safe and effective for malignant bilioduodenal obstruction. Duodenal U-SEMS is a risk factor for RBO. The covered self-expandable metal stent is the preferred type of duodenal SEMS in patients with DS (Clinical trial registration number: UMIN000027606). © 2017 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.

Expandable stents.

PubMed

Nesbitt, J C; Carrasco, H

1996-05-01

Expandable metallic stents are effective in selected patients with malignant or benign airway stenoses. When used for malignant lesions, the primary purpose of the stent is to improve the quality of life; stents are usually chosen for palliation of symptoms in recognition of the low likelihood of success for other therapy. For patients with benign stenoses, the stents provide a permanent source of structural support to alleviate the narrowed segment. The advantages of the expandable metallic stents are as follows: (1) they can be inserted through an endotracheal tube or under local anesthesia with relative simplicity under fluoroscopic guidance; (2) they do not impair the drainage of sputum because ciliary movement is not interrupted; (3) over a period of a few weeks, the meshwork is gradually covered with mucosa as the stent becomes incorporated into the airway wall; (4) ventilation usually is not impaired if the metallic mesh stent covers another nonstenosed bronchus, because the interstices of the stent are nonobstructive; and (5) they are dynamic and continue to expand over time, particularly if concurrent treatment achieves an effect on the lesion that caused stenosis. Disadvantages of the expandable stent include (1) they often are only temporarily effective for tracheobronchial stenosis due to intraluminal tumor or granulation tissue, both of which can grow between the wires; (2) they are considered permanent stents because removal is difficult; and (3) they can be poorly positioned during placement or can become displaced by progressive migration after placement, and they cannot be repositioned. A relative contraindication to insertion is an inflammatory process or infection that can predispose to granulation formation, particularly at the points of maximal contact pressure of the stent to the airway mucosa. In the presence of inflammation, it may be better to use a silicone prosthesis until the inflammatory process subsides and fibrosis occurs. Granulation tissue is less likely to occur in areas of established scar than in areas of acute inflammation. In circumstances in which it is essential that a stent remain only temporarily, an expandable stent should not be inserted in favor of a silicone stent, which can be removed. In the future, expandable stents may have silicone coverings or may be constructed of materials that facilitate removal. Until that time, expandable stents should be considered permanent and nonremovable. Subtle differences exist among the available stents. Standard is low-profile expandable construction from wire mesh. A relatively minor difference is the slightly wider expansibility of the Gianturco stent, a quality that makes it the best suited of the three stents for lesions that involve tracheomalacia. Perhaps the only major difference between the Wallstent and the Gianturco and Palmaz stents is its better ability to conform to tortuous lesions. In an acutely angled stricture, a Wallstent offers a better opportunity for successful placement than other stents. The filamentous meshwork of the Wallstent allows it to bend and conform better to distorted airways. The Gianturco and Palmaz stents have little longitudinal elasticity, which makes them less effective in a tortuous or highly angulated airway stenosis. Expandable stents have demonstrated their efficacy and exposed their limitations in the treatment of airway stenoses. Refinements in design should help to lessen specific disadvantages and problems. Covered expandable stents, a realistic prospect, have specific advantages over standard expandable stents; they will be removable and prevent tumor ingrowth. Current investigative work with such prostheses for the vascular system may provide the foundation for their investigative use in the airway. In essence, two categories of expandable stents are evolving, covered and uncovered, each having unique features adaptable to the specific clinical needs.

Clinical Results and Problems of Percutaneous Transluminal Angioplasty and Stenting for Extracranial Internal Carotid Stenoses

PubMed Central

Tsuura, M.; Terada, T.; Masuo, O.; Matsumoto, H.; Itakura, T.; Hyoutani, G.; Nakamura, Y.; Moriwaki, H.; Hayashi, S.

2001-01-01

Summary 110 patients with extracranial ICA stenosis were treated by PTA or stenting. In 21 of 55 cases of only PTA and in 40 of 55 cases of stenting, we used our blocking balloon systems to prevent distal embolism. The morbidity and the mortality rates were 5.4% and 0%, respectively. There was only one embolic complication in cases of PTA or stenting where blocking balloon systems were used. In contrast, distal embolism occurred in 3 of 34 cases of PTA without blocking balloon systems (one symptomatic case) and in 4 of 15 cases of stenting without blocking balloon systems (3 symptomatic cases). Our blocking balloon catheter system is a useful device to reduce the risk of symptomatic distal embolism. PMID:20663375

Percutaneous Transhepatic Biliary Stenting with Uncovered Self-Expandable Metallic Stents in Patients with Malignant Biliary Obstruction – Efficacy and Survival Analysis

PubMed Central

Pranculis, Andrius; Kievišienė, Lina; Vaičius, Artūras; Vanagas, Tomas; Kaupas, Rytis Stasys; Dambrauskas, Žilvinas

2017-01-01

Summary Background The aim of this study was to assess short- and long-term outcomes of malignant biliary obstruction (MBO) treatment by percutaneous transhepatic biliary stenting (PTBS) with uncovered selfexpandable metallic stents (SEMS), and to identify predictors of survival. Material/Methods A nine-year, single-centre study from a prospectively collected database included 222 patients with inoperable MBO treated by PTBS with uncovered nitinol SEMS. Results Technical and clinical success rates were 95.9% and 82.4%, respectively. The total rate of postprocedural complications was 14.4%. The mean durations of the primary and secondary stent patency were 114.7±15.1 and 146.4±21.2 days, respectively. The 30-day mortality rate was 15.3% with no procedure-related deaths. The mean estimated length of survival was 143.3±20.6 days. Independent predictors increasing the risk of death included higher than 115 μmol/L serum bilirubin 2–5 days after biliary stenting (HR 3.274, P=0.019), distal (non-hilar) obstruction of the bile ducts (HR 3.711, P=0.008), Bismuth-Corlette type IV stricture (HR 2.082, P=0.008), obstruction due to gallbladder cancer (HR 31.029, P=0.012) and only partial drainage of liver parenchyma (HR 4.158, P=0.040). Conclusions PTBS with uncovered SEMS is an effective and safe method for palliative treatment of MBO. Serum bilirubin higher than 115 μmol/L 2–5 days after the procedure has a significant negative impact on patients’ survival. Lower survival is also determined by distal bile duct obstruction, Bismuth– Corlette type IV stricture, biliary obstruction caused by gallbladder cancer and when only partial liver drainage is applied. PMID:29662569

Percutaneous Transhepatic Biliary Stenting with Uncovered Self-Expandable Metallic Stents in Patients with Malignant Biliary Obstruction - Efficacy and Survival Analysis.

PubMed

Pranculis, Andrius; Kievišas, Mantas; Kievišienė, Lina; Vaičius, Artūras; Vanagas, Tomas; Kaupas, Rytis Stasys; Dambrauskas, Žilvinas

2017-01-01

The aim of this study was to assess short- and long-term outcomes of malignant biliary obstruction (MBO) treatment by percutaneous transhepatic biliary stenting (PTBS) with uncovered selfexpandable metallic stents (SEMS), and to identify predictors of survival. A nine-year, single-centre study from a prospectively collected database included 222 patients with inoperable MBO treated by PTBS with uncovered nitinol SEMS. Technical and clinical success rates were 95.9% and 82.4%, respectively. The total rate of postprocedural complications was 14.4%. The mean durations of the primary and secondary stent patency were 114.7±15.1 and 146.4±21.2 days, respectively. The 30-day mortality rate was 15.3% with no procedure-related deaths. The mean estimated length of survival was 143.3±20.6 days. Independent predictors increasing the risk of death included higher than 115 μmol/L serum bilirubin 2-5 days after biliary stenting (HR 3.274, P =0.019), distal (non-hilar) obstruction of the bile ducts (HR 3.711, P =0.008), Bismuth-Corlette type IV stricture (HR 2.082, P =0.008), obstruction due to gallbladder cancer (HR 31.029, P =0.012) and only partial drainage of liver parenchyma (HR 4.158, P =0.040). PTBS with uncovered SEMS is an effective and safe method for palliative treatment of MBO. Serum bilirubin higher than 115 μmol/L 2-5 days after the procedure has a significant negative impact on patients' survival. Lower survival is also determined by distal bile duct obstruction, Bismuth- Corlette type IV stricture, biliary obstruction caused by gallbladder cancer and when only partial liver drainage is applied.

Plastic Biliary Stent Migration During Multiple Stents Placement and Successful Endoscopic Removal Using Intra-Stent Balloon Inflation Technique: A Case Report and Literature Review.

PubMed

Calcara, Calcedonio; Broglia, Laura; Comi, Giovanni; Balzarini, Marco

2016-02-05

Late migration of a plastic biliary stent after endoscopic placement is a well known complication, but there is little information regarding migration of a plastic stent during multiple stents placement. A white man was hospitalized for severe jaundice due to neoplastic hilar stenosis. Surgical eligibility appeared unclear on admission and endoscopy was carried out, but the first stent migrated proximally at the time of second stent insertion. After failed attempts with various devices, the migrated stent was removed successfully through cannulation with a dilation balloon. The migration of a plastic biliary stent during multiple stents placement is a possible complication. In this context, extraction can be very complicated. In our patient, cannulation of a stent with a dilation balloon was the only effective method.

Role of metallic stents in benign esophageal stricture

NASA Astrophysics Data System (ADS)

Shim, Chan Sup

2012-10-01

Simple esophageal strictures, which are focal, straight, and large in diameter, usually require 1 - 3 dilation sessions to relieve symptoms. However, complex strictures, which are long, tortuous, or associated with a severely compromised luminal diameter, are usually more difficult to treat with conventional bougie or balloon dilation techniques, and often have high recurrence rates. Although the permanent placement of self-expandable metal stents (SEMS) has been used to manage refractory benign esophageal strictures, this procedure is associated with additional problems, such as stricture from tissue hyperplasia, stent migration, and fistula formation. Thus, several new types of stents have been developed, including temporary SEMS, self-expandable plastic stents (SEPS), and biodegradable stents. The use of these new products has produced varied results. Temporary SEMS that have been used to relieve benign esophageal conditions have caused granulation tissue at both ends of the stent because of contact between the mucosa and the exposed metal components of the stent, thus hindering stent removal. We examined the tissue response to two new types of SEMS, a flange-type and a straighttype, each coated with a silicone membrane on the outside of the metal mesh. These two SEMS were evaluated individually and compared with a conventional control stent in animal experiments. Although the newly designed stents resulted in reduced tissue hyperplasia, and were thus more easily separated from the esophageal tissue, some degree of tissue hyperplasia did occur. We suggest that newly designed DES (drug-eluting stents) may provide an alternative tool to manage refractory benign esophageal stricture.

Covered versus Uncovered Self-Expandable Metal Stents for Managing Malignant Distal Biliary Obstruction: A Meta-Analysis.

PubMed

Li, Jinjin; Li, Tong; Sun, Ping; Yu, Qihong; Wang, Kun; Chang, Weilong; Song, Zifang; Zheng, Qichang

2016-01-01

To compare the efficacy of using covered self-expandable metal stents (CSEMSs) and uncovered self-expandable metal stents (UCSEMSs) to treat objective jaundice caused by an unresectable malignant tumor. We performed a comprehensive electronic search from 1980 to May 2015. All randomized controlled trials comparing the use of CSEMSs and UCSEMSs to treat malignant distal biliary obstruction were included. The analysis included 1417 patients enrolled in 14 trials. We did not detect significant differences between the UCSEMS group and the CSEMS group in terms of cumulative stent patency (hazard ratio (HR) 0.93, 95% confidence interval (CI) 0.19-4.53; p = 0.93, I2 = 0%), patient survival (HR 0.77, 95% CI 0.05-10.87; p = 0.85, I2 = 0%), overall stent dysfunction (relative ratio (RR) 0.85, M-H, random, 95% CI 0.57-1.25; p = 0.83, I2 = 63%), the overall complication rate (RR 1.26, M-H, fixed, 95% CI 0.94-1.68; p = 0.12, I2 = 0%) or the change in serum bilirubin (weighted mean difference (WMD) -0.13, IV fixed, 95% CI 0.56-0.3; p = 0.55, I2 = 0%). However, we did detect a significant difference in the main causes of stent dysfunction between the two groups. In particular, the CSEMS group exhibited a lower rate of tumor ingrowth (RR 0.25, M-H, random, 95% CI 0.12-0.52; p = 0.002, I2 = 40%) but a higher rate of tumor overgrowth (RR 1.76, M-H, fixed, 95% CI 1.03-3.02; p = 0.04, I2 = 0%). Patients with CSEMSs also exhibited a higher migration rate (RR 9.33, M-H, fixed, 95% CI 2.54-34.24; p = 0.008, I2 = 0%) and a higher rate of sludge formation (RR 2.47, M-H, fixed, 95% CI 1.36-4.50; p = 0.003, I2 = 0%). Our meta-analysis indicates that there is no significant difference in primary stent patency and stent dysfunction between CSEMSs and UCSEMSs during the period from primary stent insertion to primary stent dysfunction or patient death. However, when taking further management for occluded stents into consideration, CSEMSs is a better choice for patients with malignant biliary obstruction due to their removability.

Intelligent telemetric stent for wireless monitoring of intravascular pressure and its in vivo testing.

PubMed

Chen, Xing; Brox, Daniel; Assadsangabi, Babak; Hsiang, York; Takahata, Kenichi

2014-10-01

This paper reports a sensor-integrated telemetric stent targeted at wireless detection and monitoring of restenosis, a common vascular complication induced by stent implantation. The developed "smart" stent incorporates the design and fabrication approaches that raise the practicality of the device, being tested in an in vivo study that validates its operating principle. The stent is produced to have a gold-coated helical-like structure that serves as a high-performance inductor/antenna and integrated with a novel capacitive pressure sensor chip, all based on medical-grade stainless steel. The stent device forms an inductor-capacitor resonant tank that enables radio-frequency (RF) wireless pressure sensing in an operating frequency range of 30-80 MHz. With an overall length of 20 mm, the device is designed to be compatible with standard balloon catheters and necessary crimping process. The balloon-expanded devices are characterized in saline and blood to determine selective coating of passivation layer, Parylene C, with tailored thicknesses in order to maximize both RF and sensing abilities. In vitro testing of the devices reveals a frequency sensitivity up to 146 ppm/mmHg over a pressure range of 250 mmHg. Tests in pig models show wireless detection of device's resonance and frequency response to variations in local blood pressure, the targeted function of the device.

A novel balloon assisted two-stents telescoping technique for repositioning an embolized stent in the pulmonary conduit.

PubMed

Kobayashi, Daisuke; Gowda, Srinath T; Forbes, Thomas J

2014-08-01

A 9-year-old male, with history of pulmonary atresia and ventricular septal defect, status post complete repair with a 16 mm pulmonary homograft in the right ventricular outflow tract (RVOT) underwent 3110 Palmaz stent placement for conduit stenosis. Following deployment the stent embolized proximally into the right ventricle (RV). We undertook the choice of repositioning the embolized stent into the conduit with a transcatheter approach. Using a second venous access, the embolized stent was carefully maneuvered into the proximal part of conduit with an inflated Tyshak balloon catheter. A second Palmaz 4010 stent was deployed in the distal conduit telescoping through the embolized stent. The Tyshak balloon catheter was kept inflated in the RV to stabilize the embolized stent in the proximal conduit until it was successfully latched up against the conduit with the deployment of the overlapping second stent. One year later, he underwent Melody valve implantation in the pre-stented conduit relieving conduit insufficiency. This novel balloon assisted two-stents telescoping technique is a feasible transcatheter option to secure an embolized stent from the RV to the RVOT. © 2014 Wiley Periodicals, Inc.

77 FR 7589 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-13

... current knowledge about the safety and effectiveness of the Wingspan Stent System with Gateway PTA Balloon... premarket and postmarket data. The Wingspan Stent System with Gateway PTA Balloon Catheter is a neurovascular stent, balloon catheter, and delivery system consisting of the following components: 1. Wingspan...

Outcomes of endoscopically inserted self-expandable metal stents in malignancy according to the type of stent and the site of obstruction.

PubMed

Jung, Kyoungwon; Ahn, Ji Yong; Jung, Hwoon-Yong; Cho, Charles J; Na, Hee Kyong; Jung, Kee Wook; Lee, Jeong Hoon; Kim, Do Hoon; Choi, Kee Don; Song, Ho June; Lee, Gin Hyug; Kim, Jin-Ho

2016-09-01

Self-expandable metal stents (SEMSs) can be used for the palliation of malignant obstruction in the upper gastrointestinal tract. This study assessed the feasibility and efficacy of endoscopically inserted SEMSs for the palliation of malignant obstruction in the stomach and duodenum. Between January 2011 and April 2014, 220 patients with gastric or duodenal obstruction due to malignancy underwent endoscopic SEMS insertion at Asan Medical Center. The associations of technical/clinical outcomes and complications with the type of stent and site of obstruction were analyzed. The 220 patients included 125 men (56.8 %) and 95 women (43.2 %); median patient age was 63 years. Fully covered, partially covered, and uncovered SEMSs were inserted into 16, 77, and 120 patients, respectively. Obstructions were located in the gastric outlet, including the duodenal bulb, in 106 patients, and in the duodenal second and third portions in 114 patients. Technical success was achieved in 213 of 220 patients (96.8 %) and clinical success in 184 of 213 (86.4 %). Clinical success rates were similar to the type of stent, but were significantly greater for gastric outlet (95/104, 91.3 %) than for duodenal (89/109, 81.7 %) obstructions (p = 0.039). Stent migration was observed in 20 patients (9.1 %) and stent obstruction in 51 (23.2 %). Rates of stent migration were significantly higher for fully covered (6/16, 37.5 %) than for partially covered (7/77, 9.1 %) and uncovered (7/120, 5.8 %) SEMSs (p < 0.001) and were significantly higher for gastric outlet (16/104, 15.4 %) than for duodenal (4/109, 1.2 %) obstructions (p = 0.003). Rates of stent obstruction were similar for fully covered (2/16, 12.5 %), partially covered (17/77, 22.1 %), and uncovered (32/120, 26.7 %) SEMSs (p = 0.409) and in patients with gastric outlet (26/104, 25.0 %) and duodenal (25/109, 22.9 %) obstruction (p = 0.724). SEMS selection for malignant obstruction of the upper gastrointestinal tract depends on the site of obstruction.

Pilot study of a novel, large-bore, fully covered self-expandable metallic stent for unresectable distal biliary malignancies.

PubMed

Mukai, Tsuyoshi; Yasuda, Ichiro; Isayama, Hiroyuki; Iwashita, Takuji; Itoi, Takao; Kawakami, Hiroshi; Kogure, Hirofumi; Nakai, Yousuke

2016-09-01

In patients with unresectable malignant distal biliary obstruction, covered self-expandable metallic stents (CSEMS) may remain patent longer than uncovered self-expandable metallic stents as a result of tumor ingrowth prevention. One main cause of recurrent biliary obstruction (RBO) in CSEMS is sludge formation, which can be prevented using a large-bore stent. Therefore, we developed a novel, 12-mm diameter fully covered SEMS (FCSEMS) and investigated its clinical safety, efficacy, and rate of adverse events. This prospective, multicenter pilot study, which ran between June 2011 and November 2012, included 38 consecutive patients with unresectable malignant distal biliary obstruction. All patients underwent endoscopic insertion of our novel stent. Primary endpoint was non-RBO rate 6 months after placement. Technical and functional success rates of the procedures were 100%. Six-month non-RBO rate was 50%, and median time to RBO was 184 days. Median survival time was 241 days. Twelve patients died within 6 months after stent placement without RBO. RBO was observed in 10 patients (26%), with seven experiencing stent occlusion and three experiencing stent migration. Adverse events other than RBO (at <30 days) developed in six patients (16%; cholecystitis, one; pancreatitis, one; hyperamylasemia, one; pancreatic ductitis, one; abdominal pain, two). Stent removal for reintervention was successfully completed in eight patients. Our novel FCSEMS may be safe and effective for managing malignant distal obstruction with an acceptable incidence of adverse events. © 2016 Japan Gastroenterological Endoscopy Society.

Evidence-Based Recommendations on Upper Gastrointestinal Tract Stenting: A Report from the Stent Study Group of the Korean Society of Gastrointestinal Endoscopy

PubMed Central

Jee, Sam Ryong; Kim, Kyung Ho; Kim, Sang Gyun; Cho, Jun-Hyung

2013-01-01

Endoscopic stents have evolved dramatically over the past 20 years. With the introduction of uncovered self-expanding metal stents in the early 1990s, they are primarily used to palliate symptoms of malignant obstruction in patients with inoperable gastrointestinal (GI) cancer. At present, stents have emerged as an effective, safe, and less invasive alternative for the treatment of malignant GI obstruction. Clinical decisions about stent placement should be made based on the exact understanding of the patient's condition. These recommendations based on a critical review of the available data and expert consensus are made for the purpose of providing endoscopists with information about stent placement. These can be helpful for management of patients with inoperable cancer or various nonmalignant conditions in the upper GI tract. PMID:23964331

Interventional Cardiology: What's New?

PubMed

Scansen, Brian A

2017-09-01

Interventional cardiology in veterinary medicine continues to expand beyond the standard 3 procedures of patent ductus arteriosus occlusion, balloon pulmonary valvuloplasty, and transvenous pacing. Opportunities for fellowship training; advances in equipment, including high-resolution digital fluoroscopy, real-time 3-dimensional transesophageal echocardiography, fusion imaging, and rotational angiography; ultrasound-guided access and vascular closure devices; and refinement of techniques, including cutting and high-pressure ballooning, intracardiac and intravascular stent implantation, septal defect occlusion, transcatheter valve implantation, and hybrid approaches, are likely to transform the field over the next decade. Copyright © 2017 Elsevier Inc. All rights reserved.

Auxetic coronary stent endoprosthesis: fabrication and structural analysis.

PubMed

Amin, Faisal; Ali, Murtaza Najabat; Ansari, Umar; Mir, Mariam; Minhas, Muhammad Asim; Shahid, Wakeel

2015-07-04

Cardiovascular heart disease is one of the leading health issues in the present era and requires considerable health care resources to prevent it. The present study was focused on the development of a new coronary stent based on novel auxetic geometry which enables the stent to exhibit a negative Poisson's ratio. Commercially available coronary stents have isotropic properties, whereas the vascular system of the body shows anisotropic characteristics. This results in a mismatch between anisotropic-isotropic properties of the stent and arterial wall, and this in turn is not favorable for mechanical adhesion of the commercially available coronary stents with the arterial wall. It is believed that an auxetic coronary stent with inherent anisotropic mechanical properties and negative Poisson's ratio will have good mechanical adhesion with the arterial wall. The auxetic design was obtained via laser cutting, and surface treatment was performed with acid pickling and electropolishing, followed by an annealing process. In vitro mechanical analysis was performed to analyze the mechanical performance of the auxetic coronary stent. Scanning electronic microscopy (SEM) was used to determine the effects of fabrication processes on the topography of the auxetic stent. The elastic recoil (3.3%) of the in vitro mechanical analysis showed that the auxetic stent design effectively maintained the luminal patency of the coronary artery. Also, the auxetic coronary stent showed no foreshortening, therefore it avoids the problem of stent migration, by expanding in both the radial and longitudinal directions. By virtue of its synclastic behavior, the auxetic stent bulges outward when it is radially expanded through an inflated balloon.

Durability of the balloon-expandable covered versus bare-metal stents in the Covered versus Balloon Expandable Stent Trial (COBEST) for the treatment of aortoiliac occlusive disease.

PubMed

Mwipatayi, Bibombe P; Sharma, Surabhi; Daneshmand, Ali; Thomas, Shannon D; Vijayan, Vikram; Altaf, Nishath; Garbowski, Marek; Jackson, Mark

2016-07-01

The Covered vs Balloon Expandable Stent Trial (COBEST) is the first multicenter trial to investigate the patency of covered stents (CSs) and bare-metal stents (BMSs) in the treatment of aortoiliac arterial disease. The short-term results demonstrated that CSs were superior to BMSs in maintaining patency for TransAtlantic Inter-Society Consensus (TASC) C and D lesions at 18 months and were equivalent to BMSs for TASC B lesions. The current study was conducted to determine if the initial patency advantage of CSs over BMSs was sustained at the 5-year follow-up. A retrospective post hoc analysis of COBEST was performed. Originally, 125 patients with 168 iliac arteries were prospectively enrolled and randomly assigned to receive a CS or BMS. In this study, 77 of the 125 patients (61.6%; 119 limbs) were assessed at 60 months for the primary and secondary end points, with particular attention paid to the outcomes stratified according to TASC lesion severity. The primary end point was the rate of binary stenosis or freedom from stent occlusion of the treated area, as determined by ultrasound imaging or quantitative visual angiography. The 5-year results of the COBEST showed that the CS had a significantly higher patency rate than the BMS at 18, 24, 48, and 60 months (95.1%, 82.1%, 79.9%, 74.7% for CS vs 73.9%, 70.9%, 63% and 62.5% for BMS; log-rank test, P = .01). On multivariate analysis, the type of stent used (hazard ratio [HR], 2.797; 95% confidence interval [CI], 1.471-5.318; P = .002) and the Rutherford classification (HR, 2.019; 95% CI, 1.278-3.191; P = .026) significantly affected the adjusted primary patency. On subgroup analysis, the CS showed significantly higher patency and a survival benefit compared with the BMS in TASC C and D lesions (HR, 8.639; 95% CI, 54.253-75.753; P = .003). Moreover, fewer patients received target limb revascularization in the CS group than in the BMS group (odds ratio, 2.32; 95% CI, 1.47-3.36; P = .02); however, there was no statistically significant difference in the rate of amputations between the groups. The 5-year results of the COBEST demonstrated that the CS has an enduring patency advantage over the BMS in both the short and long terms. Furthermore, the CS showed acceptable patency rates for the treatment of more severe TASC C and D lesions, and patients who received a CS required fewer revascularization procedures. However, the choice of stent did not affect the rate of major limb amputations. Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

Endovascular Exclusion of Visceral Artery Aneurysms with Stent-Grafts: Technique and Long-Term Follow-up

DOE Office of Scientific and Technical Information (OSTI.GOV)

Rossi, Michele; Rebonato, Alberto, E-mail: albertorebonato@libero.it; Greco, Laura

This paper describes four cases of visceral artery aneurysms (VAAs) successfully treated with endovascular stent-grafts and discusses the endovascular approach to VAAs and the long-term results. Four balloon expandable stent-grafts were used to treat three splenic artery aneurysms and one bleeding common hepatic artery pseudoaneurysm. The percutaneous access site and the materials were chosen on the basis of CT angiography findings. In all cases the aneurysms were successfully excluded. In one case a splenic infarction occurred, with nonrelevant clinical findings. At 16- to 24-month follow-up three patients had patent stents and complete exclusion and shrinkage of the aneurysms. One patientmore » died due to pancreatitis and sepsis, 16 days after successful stenting and exclusion of a bleeding pseudoaneurysm. We conclude that endovascular treatment using covered stent-grafts is a valid therapeutic option for VAAs. Multislice CT preoperative study helps in planning stent-graft positioning.« less

Application of self-expandable metal stents for ureteroileal anastomotic strictures: long-term results.

PubMed

Liatsikos, Evangelos N; Kagadis, George C; Karnabatidis, Dimitrios; Katsanos, Konstantinos; Papathanassiou, Zafiria; Constantinides, Constantinos; Perimenis, Petros; Nikiforidis, George C; Stolzenburg, Jens-Uwe; Siablis, Dimitrios

2007-07-01

We report our long-term experience with the management of benign ureteroileal anastomotic strictures using self-expandable metal stents. A total of 16 male and 2 female patients with a mean+/-SD age of 72+/-7 years (range 66 to 78) with benign fibrotic strictures at the site of ureteroileal anastomosis underwent implantation of self-expandable metal stents with a nominal diameter of 6 to 8 mm. A total of 24 ureteroileal conduits were treated. The external nephrostomy tubes were removed after fluoroscopic validation of ureteral patency. Patients were followed with blood biochemistry, ultrasonography, urography and/or virtual endoscopy. Retrograde external-internal catheter insertion through the cutaneous stoma was performed in cases of recalcitrant stricture. The technical success rate of ureteroileal stricture crossing and stenting was 100% (24 of 24 cases). Mean followup was 21 months (range 7 to 50). The clinical success rate during the immediate post-stenting period was 70.8% (17 of 24 cases). The 1 and 4-year primary patency rates were 37.8% and 22.7%, respectively. Secondary interventions included repeat balloon dilation in 15 ureters, of which 8 also underwent subsequent coaxial stent placement. The 1 and 4-year secondary patency rates were 64.8% and 56.7%, respectively. Except in 2 patients who died external-internal Double-J catheters continued to be inserted retrograde in 6 ureteroileal conduits. They are periodically exchanged to prevent mucous inspissation and stent encrustation. Metal stents served as the definitive treatment for stricture in more than half of the cases, whereas in the remainder the stents allowed the uncomplicated and regular exchange of Double-J catheters in retrograde fashion. This combined, less invasive treatment for ureteroileal anastomotic strictures may help patients avoid surgical revision and preserve quality of life.

Stent Recanalization of Chronic Portal Vein Occlusion in a Child

DOE Office of Scientific and Technical Information (OSTI.GOV)

Cwikiel, Wojciech; Solvig, Jan; Schroder, Henrik

2000-07-15

An 8-year-old boy with a 21/2 year history of portal hypertension and repeated bleedings from esophageal varices, was referred for treatment. The 3.5-cm-long occlusion of the portal vein was passed and the channel created was stabilized with a balloon-expandable stent; a portosystemic stent-shunt was also created. The portosystemic shunt closed spontaneously within 1 month, while the recanalized segment of the portal vein remained open. The pressure gradient between the intrahepatic and extrahepatic portal vein branches dropped from 17 mmHg to 0 mmHg. The pressure in the portal vein dropped from 30 mmHg to 17 mmHg and the bleedings stopped. Themore » next dilation of the stent was performed 12 months later due to an increased pressure gradient; the gastroesophageal varices disappeared completely. Further dilation of the stent was planned after 2, 4, and 6 years.« less

Predictive factors for the failure of endoscopic stent-in-stent self-expandable metallic stent placement to treat malignant hilar biliary obstruction

PubMed Central

Sugimoto, Mitsuru; Takagi, Tadayuki; Suzuki, Rei; Konno, Naoki; Asama, Hiroyuki; Watanabe, Ko; Nakamura, Jun; Kikuchi, Hitomi; Waragai, Yuichi; Takasumi, Mika; Sato, Yuki; Hikichi, Takuto; Ohira, Hiromasa

2017-01-01

AIM To investigate the factors predictive of failure when placing a second biliary self-expandable metallic stents (SEMSs). METHODS This study evaluated 65 patients with an unresectable malignant hilar biliary obstruction who were examined in our hospital. Sixty-two of these patients were recruited to the study and divided into two groups: the success group, which consisted of patients in whom a stent-in-stent SEMS had been placed successfully, and the failure group, which consisted of patients in whom the stent-in-stent SEMS had not been placed successfully. We compared the characteristics of the patients, the stricture state of their biliary ducts, and the implemented endoscopic retrograde cholangiopancreatography (ERCP) procedures between the two groups. RESULTS The angle between the target biliary duct stricture and the first implanted SEMS was significantly larger in the failure group than in the success group. There were significantly fewer wire or dilation devices (ERCP catheter, dilator, or balloon catheter) passing the first SEMS cell in the failure group than in the success group. The cut-off value of the angle predicting stent-in-stent SEMS placement failure was 49.7 degrees according to the ROC curve (sensitivity 91.7%, specificity 61.2%). Furthermore, the angle was significantly smaller in patients with wire or dilation devices passing the first SEMS cell than in patients without wire or dilation devices passing the first SEMS cell. CONCLUSION A large angle was identified as a predictive factor for failure of stent-in-stent SEMS placement. PMID:28974893

Predictive factors for the failure of endoscopic stent-in-stent self-expandable metallic stent placement to treat malignant hilar biliary obstruction.

PubMed

Sugimoto, Mitsuru; Takagi, Tadayuki; Suzuki, Rei; Konno, Naoki; Asama, Hiroyuki; Watanabe, Ko; Nakamura, Jun; Kikuchi, Hitomi; Waragai, Yuichi; Takasumi, Mika; Sato, Yuki; Hikichi, Takuto; Ohira, Hiromasa

2017-09-14

To investigate the factors predictive of failure when placing a second biliary self-expandable metallic stents (SEMSs). This study evaluated 65 patients with an unresectable malignant hilar biliary obstruction who were examined in our hospital. Sixty-two of these patients were recruited to the study and divided into two groups: the success group, which consisted of patients in whom a stent-in-stent SEMS had been placed successfully, and the failure group, which consisted of patients in whom the stent-in-stent SEMS had not been placed successfully. We compared the characteristics of the patients, the stricture state of their biliary ducts, and the implemented endoscopic retrograde cholangiopancreatography (ERCP) procedures between the two groups. The angle between the target biliary duct stricture and the first implanted SEMS was significantly larger in the failure group than in the success group. There were significantly fewer wire or dilation devices (ERCP catheter, dilator, or balloon catheter) passing the first SEMS cell in the failure group than in the success group. The cut-off value of the angle predicting stent-in-stent SEMS placement failure was 49.7 degrees according to the ROC curve (sensitivity 91.7%, specificity 61.2%). Furthermore, the angle was significantly smaller in patients with wire or dilation devices passing the first SEMS cell than in patients without wire or dilation devices passing the first SEMS cell. A large angle was identified as a predictive factor for failure of stent-in-stent SEMS placement.

Endovascular Treatment of Infrarenal Abdominal Aortic Lesions With or Without Common Iliac Artery Involvement

DOE Office of Scientific and Technical Information (OSTI.GOV)

Oender, Hakan, E-mail: drhakanonder@hotmail.com; Oguzkurt, Levent; Guer, Serkan

To evaluate the results of stent placement for obstructive atherosclerotic aortic disease with or without involvement of the common iliac artery. Forty patients had self-expanding stents primarily or after balloon dilatation in the abdominal aorta between January 2005 and May 2011. All patients had trouble walking. Follow-up examinations were performed with clinical visits; these included color Doppler ultrasonography and computed tomographic angiography. Technical, clinical, and hemodynamic success was achieved in all patients. None of the patients underwent reintervention during the follow-up period, which ranged from 3 months to 6 years (median 24 months). Nine complications occurred in six patients. Ofmore » the nine complications, four were distal thromboembolisms, which were successfully treated with catheter-directed thrombolysis or anticoagulation therapy. Endovascular treatment of the obstructive aortic disease using self-expanding stents was safe and effective, with high technical success and long-term patency. Thromboembolic complications were high even though direct stenting was considered protective for thromboembolism formation. Particularly for infrarenal aortic stenosis, it can be recommended as the first-line treatment option for patients with obstructive atherosclerotic aortic disease.« less

Current trends in stenting for aortic coarctation in Japan: Subanalysis of Japanese Society of Pediatric Interventional Cardiology (JPIC) stent survey.

PubMed

Fujii, Takanari; Tomita, Hideshi; Otsuki, Shinichi; Kobayashi, Toshiki; Ono, Yasuo; Yazaki, Satoshi; Kim, Sung-Hae; Nakanishi, Toshio

2016-02-01

Stenting for aortic coarctation (CoA) has been accepted as an alternative to surgery for adolescents and adults, but only a few case have been reported in Japan. The purpose of this study was to provide a detailed review of Japanese national data on stenting of CoA. In a subanalysis of the data of the Japanese Society of Pediatric Interventional Cardiology (JPIC), we identified 35 patients with CoA who underwent stenting. We analyzed procedural characteristics including factors that may have contributed to hemodynamic effectiveness, and we compared these parameters between the patients under and over 15 years of age. The mean ratio of balloon diameter/minimum lumen diameter (MLD) before stenting was 1.7 (range, 1.2-4.0), and the mean difference between the balloon diameter and the reference vessel diameter was -0.7 mm (range, -5.0 to +3.0 mm). %MLD/balloon diameter, which was defined as [(balloon diameter - MLD after dilation)/balloon diameter] × 100 predicted achievement of <10 mmHg pressure gradient after stenting. The sensitivity and the specificity of its cut-off of 7% were 93% and 47% (AUC, 0.7), respectively. There was no statistical difference between the two age groups under and over 15 years of age, in terms of selection criteria of stent size, balloon type used for deployment and immediate angiographic and hemodynamic result. Stenting for CoA was clinically effective with few complications in Japan, even in patients not fully grown. © 2015 Japan Pediatric Society.

Modified jailed balloon technique for bifurcation lesions.

PubMed

Saito, Shigeru; Shishido, Koki; Moriyama, Noriaki; Ochiai, Tomoki; Mizuno, Shingo; Yamanaka, Futoshi; Sugitatsu, Kazuya; Tobita, Kazuki; Matsumi, Junya; Tanaka, Yutaka; Murakami, Masato

2017-12-04

We propose a new systematic approach in bifurcation lesions, modified jailed balloon technique (M-JBT), and report the first clinical experience. Side branch occlusion brings with a serious complication and occurs in more than 7.0% of cases during bifurcation stenting. A jailed balloon (JB) is introduced into the side branch (SB), while a stent is placed in the main branch (MB) as crossing SB. The size of the JB is half of the MB stent size. While the proximal end of JB attaching to MB stent, both stent and JB are simultaneously inflated with same pressure. JB is removed and then guidewires are recrossed. Kissing balloon dilatation (KBD) and/or T and protrusion (TAP) stenting are applied as needed. Between February 2015 and February 2016, 233 patients (254 bifurcation lesions including 54 left main trunk disease) underwent percutaneous coronary intervention (PCI) using this technique. Procedure success was achieved in all cases. KBD was performed for 183 lesions and TAP stenting was employed for 31 lesions. Occlusion of SV was not observed in any of the patients. Bench test confirmed less deformity of MB stent in M-JBT compared with conventional-JBT. This is the first report for clinical experiences by using modified jailed balloon technique. This novel M-JBT is safe and effective in the preservation of SB patency during bifurcation stenting. © 2017 Wiley Periodicals, Inc.

Endoscopic removal and trimming of distal self-expandable metallic biliary stents

PubMed Central

Ishii, Kentaro; Itoi, Takao; Sofuni, Atsushi; Itokawa, Fumihide; Tsuchiya, Takayoshi; Kurihara, Toshio; Tsuji, Shujiro; Ikeuchi, Nobuhito; Umeda, Junko; Moriyasu, Fuminori; Tsuchida, Akihiko

2011-01-01

AIM: To evaluate the efficacy and safety of endoscopic removal and trimming of self-expandable metallic stents (SEMS). METHODS: All SEMS had been placed for distal biliary strictures. Twenty-seven endoscopic procedures were performed in 19 patients in whom SEMS (one uncovered and 18 covered) removal had been attempted, and 8 patients in whom stent trimming using argon plasma coagulation (APC) had been attempted at Tokyo Medical University Hospital. The APC settings were: voltage 60-80 W and gas flow at 1.5 L/min. RESULTS: The mean stent indwelling period for all patients in whom stent removal had been attempted was 113.7 ± 77.6 d (range, 8-280 d). Of the 19 patients in whom removal of the SEMS had been attempted, the procedure was successful in 14 (73.7%) without procedure-related adverse events. The indwelling period in the stent removable group was shorter than that in the unremovable group (94.9 ± 71.5 d vs 166.2 ± 76.2 d, P = 0.08). Stent trimming was successful for all patients with one minor adverse event consisting of self-limited hemorrhage. Trimming time ranged from 11 to 16 min. CONCLUSION: Although further investigations on larger numbers of cases are necessary to accumulate evidence, the present data suggested that stent removal and stent trimming is feasible and effective for stent-related complications. PMID:21677835

Covered versus Uncovered Self-Expandable Metal Stents for Managing Malignant Distal Biliary Obstruction: A Meta-Analysis

PubMed Central

Sun, Ping; Yu, Qihong; Wang, Kun; Chang, Weilong; Song, Zifang; Zheng, Qichang

2016-01-01

Aim To compare the efficacy of using covered self-expandable metal stents (CSEMSs) and uncovered self-expandable metal stents (UCSEMSs) to treat objective jaundice caused by an unresectable malignant tumor. Methods We performed a comprehensive electronic search from 1980 to May 2015. All randomized controlled trials comparing the use of CSEMSs and UCSEMSs to treat malignant distal biliary obstruction were included. Results The analysis included 1417 patients enrolled in 14 trials. We did not detect significant differences between the UCSEMS group and the CSEMS group in terms of cumulative stent patency (hazard ratio (HR) 0.93, 95% confidence interval (CI) 0.19–4.53; p = 0.93, I2 = 0%), patient survival (HR 0.77, 95% CI 0.05–10.87; p = 0.85, I2 = 0%), overall stent dysfunction (relative ratio (RR) 0.85, M-H, random, 95% CI 0.57–1.25; p = 0.83, I2 = 63%), the overall complication rate (RR 1.26, M-H, fixed, 95% CI 0.94–1.68; p = 0.12, I2 = 0%) or the change in serum bilirubin (weighted mean difference (WMD) -0.13, IV fixed, 95% CI 0.56–0.3; p = 0.55, I2 = 0%). However, we did detect a significant difference in the main causes of stent dysfunction between the two groups. In particular, the CSEMS group exhibited a lower rate of tumor ingrowth (RR 0.25, M-H, random, 95% CI 0.12–0.52; p = 0.002, I2 = 40%) but a higher rate of tumor overgrowth (RR 1.76, M-H, fixed, 95% CI 1.03–3.02; p = 0.04, I2 = 0%). Patients with CSEMSs also exhibited a higher migration rate (RR 9.33, M-H, fixed, 95% CI 2.54–34.24; p = 0.008, I2 = 0%) and a higher rate of sludge formation (RR 2.47, M-H, fixed, 95% CI 1.36–4.50; p = 0.003, I2 = 0%). Conclusions Our meta-analysis indicates that there is no significant difference in primary stent patency and stent dysfunction between CSEMSs and UCSEMSs during the period from primary stent insertion to primary stent dysfunction or patient death. However, when taking further management for occluded stents into consideration, CSEMSs is a better choice for patients with malignant biliary obstruction due to their removability. PMID:26859673

Intravascular stenting in the superior mesenteric artery for chronic abdominal angina.

PubMed

Busquet, J

1997-11-01

Abdominal angina is an early clinical expression of occlusive mesenteric arterial insufficiency, a condition that requires aggressive treatment to prevent intestinal infarction. We report a case of chronic mesenteric ischemia in a young polyvascular man who had symptoms of abdominal angina. An aortic angiogram revealed a significant ostial stenosis of the superior mesenteric artery (SMA) associated with an occlusion of the inferior mesenteric artery. After predilation of the ostial portion of the SMA, significant residual stenosis remained. A balloon-expandable Palmaz P154 stent was deployed, restoring adequate luminal dimensions and blood flow. The patient was discharged after 2 days and remains asymptomatic at 5 months. Intraluminal stenting for treatment of mesenteric ischemia represents a viable alternative to surgical revascularization in selected cases.

SEMS vs cSEMS in duodenal and small bowel obstruction: High risk of migration in the covered stent group

PubMed Central

Waidmann, Oliver; Trojan, Jörg; Friedrich-Rust, Mireen; Sarrazin, Christoph; Bechstein, Wolf Otto; Ulrich, Frank; Zeuzem, Stefan; Albert, Jörg Gerhard

2013-01-01

AIM: To compare clinical success and complications of uncovered self-expanding metal stents (SEMS) vs covered SEMS (cSEMS) in obstruction of the small bowel. METHODS: Technical success, complications and outcome of endoscopic SEMS or cSEMS placement in tumor related obstruction of the duodenum or jejunum were retrospectively assessed. The primary end points were rates of stent migration and overgrowth. Secondary end points were the effect of concomitant biliary drainage on migration rate and overall survival. The data was analyzed according to the Strengthening the Reporting of Observational Studies in Epidemiology guidelines. RESULTS: Thirty-two SEMS were implanted in 20 patients. In all patients, endoscopic stent implantation was successful. Stent migration was observed in 9 of 16 cSEMS (56%) in comparison to 0/16 SEMS (0%) implantations (P = 0.002). Stent overgrowth did not significantly differ between the two stent types (SEMS: 3/16, 19%; cSEMS: 2/16, 13%). One cSEMS dislodged and had to be recovered from the jejunum by way of laparotomy. Time until migration between SEMS and cSEMS in patients with and without concomitant biliary stents did not significantly differ (HR = 1.530, 95%CI 0.731-6.306; P = 0.556). The mean follow-up was 57 ± 71 d (range: 1-275 d). CONCLUSION: SEMS and cSEMS placement is safe in small bowel tumor obstruction. However, cSEMS is accompanied with a high rate of migration in comparison to uncovered SEMS. PMID:24115817

Concurrent Angioplasty Balloon Placement for Stent Delivery through Jugular Venous Bulb for Treating Cerebral Venous Sinus Stenosis. Technical Report.

PubMed

Qureshi, Adnan I; Khan, Asif A; Capistrant, Rachel; Qureshi, Mushtaq H; Xie, Kevin; Suri, M Fareed K

2016-10-01

To report upon technique of concurrent placement of angioplasty balloon at the internal jugular vein and sigmoid venous sinus junction to facilitate stent delivery in two patients in whom stent delivery past the jugular bulb was not possible. A 21-year-old woman and a 41-year-old woman with worsening headaches, visual obscuration or diplopia were treated for pseudotumor cerebri associated with transverse venous stenosis. Both patients had undergone primary angioplasty, which resulted in improvement in clinical symptoms followed by the recurrence of symptoms with restenosis at the site of angioplasty. After multiple attempts at stent delivery through jugular venous bulb were unsuccessful, a second guide catheter was placed in the ipsilateral internal jugular vein through contralateral femoral venous approach. A 6 mm × 20 mm (left) or 5 × 15 mm (right) angioplasty balloon was placed across the internal jugular vein and sigmoid sinus junction and partially inflated until the inflation and relative straightening of the junction was observed. In both patients, the internal jugular vein and sigmoid sinus junction was successfully traversed by the stent delivery system in a parallel alignment to inflated balloon. Balloon mounted stent was deployed at the site of restenosis with near complete resolution of lumen narrowing delivery and improvement in clinical symptoms. We report a technique for realignment and diameter change with concurrent placement and partial inflation of angioplasty balloon at the jugular venous bulb to facilitate stent delivery into the sigmoid and transverse venous sinuses in circumstances where multiple attempts at stent delivery are unsuccessful.

Customized Hinged Covered Metallic Stents for the Treatment of Benign Main Bronchial Stenosis.

PubMed

Han, Xinwei; Al-Tariq, Quazi; Zhao, Yanle; Li, Lei; Cheng, Zhe; Wang, Huaqi; Liu, Chao; Jiao, Dechao; Wu, Gang

2017-08-01

To address the limitations of silicone stents, we designed a hinged self-expandable covered metallic stent. The aim of this study was to evaluate the safety and efficacy of the customized stents in clinical applications. This was a retrospective analysis. Under conscious sedation and local anesthesia, the stents were implanted or removed by interventional radiologists, with fluoroscopic guidance. Of 24 patients with benign main bronchial stenosis, stents were successfully placed in 21 (87.5%). The low-pressure balloon before dilation failed in 1 case (4.17%) of left main bronchial cicatricial stenosis. In 2 other cases (8.33%), stent placement was abandoned. Stents were successfully removed between 29 and 103 days after the procedure. After stent removal, the follow-up lasted for at least 12 months. Restenosis occurred only in 1 case (4.55%) owing to bronchial collapse 3 days after stent removal. Dyspnea occurred in another case (4.55%) at 2 months after retrieval; recurrence was confirmed using bronchoscopy, leading to a left pneumonectomy. The described procedure is safe and easy to be performed and avoids the use of intubation, bronchoscopy, and general anesthesia. Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

A Novel Partially Covered Self-Expandable Metallic Stent with Proximal Flare in Patients with Malignant Gastric Outlet Obstruction.

PubMed

Takahara, Naminatsu; Isayama, Hiroyuki; Nakai, Yousuke; Yoshida, Shuntaro; Saito, Tomotaka; Mizuno, Suguru; Yagioka, Hiroshi; Kogure, Hirofumi; Togawa, Osamu; Matsubara, Saburo; Ito, Yukiko; Yamamoto, Natsuyo; Tada, Minoru; Koike, Kazuhiko

2017-07-15

Endoscopic placement of self-expandable metal stents (SEMSs) has emerged as a palliative treatment for malignant gastric outlet obstruction (GOO). Although covered SEMSs can prevent tumor ingrowth, frequent migration of covered SEMSs may offset their advantages in preventing tumor ingrowth. We conducted this multicenter, single-arm, retrospective study at six tertiary referral centers to evaluate the safety and efficacy of a partially covered SEMS with an uncovered large-bore flare at the proximal end as an antimigration system in 41 patients with symptomatic malignant GOO. The primary outcome was clinical success, and the secondary outcomes were technical success, stent dysfunction, adverse events, and survival after stent placement. The technical and clinical success rates were 100% and 95%, respectively. Stent dysfunctions occurred in 17 patients (41%), including stent migration in nine (23%), tumor ingrowth in one (2%), and tumor overgrowth in four (10%). Two patients (5%) developed adverse events: one pancreatitis and one perforation. No procedure-related death was observed. A novel partially covered SEMS with a large-bore flare proximal end was safe and effective for malignant GOO but failed to prevent stent migration. Further research is warranted to develop a covered SEMS with an optimal antimigration system.

[Use of esophageal small balloon or papillary sphincter knife in the treatment of stent implantation 
for colorectal malignant obstruction].

PubMed

Xiao, Dinghua; Liu, Shaojun; Yan, Hanguang; Wang, Xiaoyan

2018-05-28

To explore the function of esophageal small balloon or papillary sphincter knife in the treatment of stent implantation for colorectal malignant obstruction, and to improve the success rate of colonic stent placement in such patients.
 Methods: A total of 49 patients with colorectal cancer complicated with almost complete obstruction or colorectal cancer were enrolled for this study. The esophageal small balloon or papillary sphincter knife was used in the guide wires. The guide wires gradually crossed the tumor gap and they were placed in the contralateral intestinal cavity with balloon progression. X-ray was then used to confirm whether the guide wire was inserted in the lesion intestinal cavity, and then the metal bare stent was inserted.
 Results: The guide wires was successfully inserted with conventional methods in these 49 cases, while they were also successfully placed the guide wire and the stent in the new way.
 Conclusion: For the patients with colorectal cancer complicated with complete obstruction or colorectal cancer located in obviously angled location, the use of esophageal small balloon or papillary sphincter knife can help the guide wire insert. They greatly improve the success rate of stent implantation.

Double Guiding Catheters for Complex Percutaneous Coronary Intervention

PubMed Central

Chou, Shing-Hsien; Lin, Chia-Pin; Lin, Yen-Chen; Kuo, Chi-Tai; Lin, Ming-Shyan; Chang, Chi-Jen

2012-01-01

A large-lumen guiding catheter is often used for complex percutaneous coronary intervention—particularly when a final kissing-balloon or 2-stent technique is required. However, catheter insertion is sometimes restricted by diseased vascular access sites or a tortuous vascular route. We report 2 cases in which a unique double guiding catheter technique was used to create a lumen of sufficient size for complex percutaneous coronary intervention. In each patient, two 6F guiding catheters were used concurrently to engage the ostium of 1 target vessel. In 1 patient, these catheters were used for the delivery of 2 balloons to complete kissing-balloon dilation after single-stent placement. In the other patient, the catheters were used to deliver 2 stents sequentially to their respective target lesions. The stents were then deployed simultaneously as kissing stents, followed by high-pressure kissing-balloon postdilation. PMID:22412243

Paclitaxel Drug-Eluting Stents in Peripheral Arterial Disease: A Health Technology Assessment

PubMed Central

2015-01-01

Background Peripheral arterial disease is a condition in which atherosclerotic plaques partially or completely block blood flow to the legs. Although percutaneous transluminal angioplasty and metallic stenting have high immediate success rates in treating peripheral arterial disease, long-term patency and restenosis rates in long and complex lesions remain unsatisfactory. Objective The objective of this analysis was to evaluate the clinical effectiveness, safety, cost-effectiveness and budget impact of Zilver paclitaxel self-expanding drug-eluting stents for the treatment of de novo or restenotic lesions in above-the-knee peripheral arterial disease. Data Sources Literature searches were performed using Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid Embase, EBSCO Cumulative Index to Nursing & Allied Health Literature (CINAHL), and EBM Reviews. For the economic review, a search filter was applied to limit search results to economics-related literature. Data sources for the budget impact analysis included expert opinion, published literature, and Ontario administrative data. Review Methods Systematic reviews, meta-analyses, randomized controlled trials, and observational studies were included in the clinical effectiveness review, and full economic evaluations were included in the economic literature review. Studies were included if they examined the effect of Zilver paclitaxel drug-eluting stents in de novo or restenotic lesions in above-the-knee arteries. For the budget impact analysis, 3 scenarios were constructed based on different assumptions. Results One randomized controlled trial reported a significantly higher patency rate with Zilver paclitaxel drug-eluting stents for lesions ≤ 14 cm than with angioplasty or bare metal stents. One observational study showed no difference in patency rates between Zilver paclitaxel drug-eluting stents and paclitaxel drug-coated balloons. Zilver paclitaxel drug-eluting stents were associated with a significantly higher event-free survival rate than angioplasty, but the event-free survival rate was similar for Zilver paclitaxel drug-eluting stents and paclitaxel drug-coated balloons. No economic evaluations compared Zilver paclitaxel drug-eluting stents with bare metal stents or angioplasty for peripheral arterial disease. A budget impact analysis showed that the cost savings associated with funding of Zilver paclitaxel drug-eluting stents would be $470,000 to $640,000 per year, assuming that the use of the Zilver paclitaxel drug-eluting stent was associated with a lower risk of subsequent revascularization. Conclusions Based on evidence of low to moderate quality, Zilver paclitaxel drug-eluting stents were associated with a higher patency rate than angioplasty or bare metal stents, and with fewer adverse events than angioplasty. The effectiveness and safety of Zilver paclitaxel drug-eluting stents and paclitaxel drug-coated balloons were similar. PMID:26719778

[Anesthetic management of tracheobronchial stent insertion in patients who underwent laser resection, balloon dilatation and tracheostomy in advance].

PubMed

Hirai, Akiko; Hirose, Yoshifumi; Gamoh, Masahiro; Satoh, Minako

2005-10-01

We report successful management of tracheobronchial stent insertion under general anesthesia. In thirty-two cases, tracheobronchial stent insertion was performed under general anesthesia. The technique for airway management was chosen depending on the type of stent or the constriction level of the airway portion. We employed tracheostomy in order to avoid repeated intubations during the insertion of Dumon or Dynamic stent. In case of severe airway stenosis, laser resection or balloon dilatation was performed before stent insertion. We had 32 successful cases in 36 trials. Four trials failed due to insufficient expansion in one, mismatches of stent angle in one and pneumomediastinum in one. There was no exacerbation of respiratory condition in failed cases. There was no case who needed percutaneous cardiopulmonary support system. We managed tracheobronchial stent insertion under general anesthesia. Both the airway expansion by laser resection or balloon dilatation before stent insertion and also the insertion of Dumon or Dynamic stent through a tracheostomy were helpful strategies. These techniques facilitated more definitive airway maintenance and stable anesthetic management.

Ascending Aortic Stenting for Acute Supraaortic Stenosis From Graft Collapse.

PubMed

Lader, Joshua M; Smith, Deane E; Staniloae, Cezar; Fallahi, Arzhang; Iqbal, Sohah N; Galloway, Aubrey C; Williams, Mathew R

2018-06-01

A 78-year-old man with remote type-A dissection presented with acute-onset dyspnea. Twenty-two years prior, treatment for his aortic disease required replacement of ascending and arch aneurysms with a polyester graft (Dacron) using the graft inclusion technique. He presented currently in cardiogenic shock. Echocardiography demonstrated new severe hypokinesis of all apical segments. Left-heart catheterization revealed a 120 mm Hg intragraft gradient. Computed tomography arteriography was unrevealing, but intraaortic ultrasound demonstrated critical intragraft stenosis. A balloon expandable stent (Palmaz stent, Cordis, Milpitas, CA) was deployed in the stenotic region with gradient resolution. The patient later underwent aortic root replacement and ascending aneurysm repair (Bio-Bentall technique) and is doing well at 24 months. Copyright © 2018 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Treatment strategies for coronary in-stent restenosis: systematic review and hierarchical Bayesian network meta-analysis of 24 randomised trials and 4880 patients

PubMed Central

Giacoppo, Daniele; Gargiulo, Giuseppe; Aruta, Patrizia; Capranzano, Piera; Tamburino, Corrado

2015-01-01

Study question What is the most safe and effective interventional treatment for coronary in-stent restenosis? Methods In a hierarchical Bayesian network meta-analysis, PubMed, Embase, Scopus, Cochrane Library, Web of Science, ScienceDirect, and major scientific websites were screened up to 10 August 2015. Randomised controlled trials of patients with any type of coronary in-stent restenosis (either of bare metal stents or drug eluting stents; and either first or recurrent instances) were included. Trials including multiple treatments at the same time in the same group or comparing variants of the same intervention were excluded. Primary endpoints were target lesion revascularisation and late lumen loss, both at six to 12 months. The main analysis was complemented by network subanalyses, standard pairwise comparisons, and subgroup and sensitivity analyses. Study answer and limitations Twenty four trials (4880 patients), including seven interventional treatments, were identified. Compared with plain balloons, bare metal stents, brachytherapy, rotational atherectomy, and cutting balloons, drug coated balloons and drug eluting stents were associated with a reduced risk of target lesion revascularisation and major adverse cardiac events, and with reduced late lumen loss. Treatment ranking indicated that drug eluting stents had the highest probability (61.4%) of being the most effective for target lesion vascularisation; drug coated balloons were similarly indicated as the most effective treatment for late lumen loss (probability 70.3%). The comparative efficacy of drug coated balloons and drug eluting stents was similar for target lesion revascularisation (summary odds ratio 1.10, 95% credible interval 0.59 to 2.01) and late lumen loss reduction (mean difference in minimum lumen diameter 0.04 mm, 95% credible interval −0.20 to 0.10). Risks of death, myocardial infarction, and stent thrombosis were comparable across all treatments, but these analyses were limited by a low number of events. Trials had heterogeneity regarding investigation periods, baseline characteristics, and endpoint reporting, with a lack of information at long term follow-up. Direct and indirect evidence was also inconsistent for the comparison between drug eluting stents and drug coated balloons. What this study adds Compared with other currently available interventional treatments for coronary in-stent restenosis, drug coated balloons and drug eluting stents are associated with superior clinical and angiographic outcomes, with a similar comparative efficacy. Funding, competing interests, data sharing This study received no external funding. The authors declare no competing interests. No additional data available. PMID:26537292

Treatment of gastric leaks with coated self-expanding stents after sleeve gastrectomy.

PubMed

Serra, Carlos; Baltasar, Aniceto; Andreo, Luis; Pérez, Nieves; Bou, Rafael; Bengochea, Marcelo; Chisbert, Juan José

2007-07-01

Duodenal switch (DS) is one of the most effective techniques for the treatment of morbid obesity and its co-morbidities, with mortality rate <1%, but with 9.4% morbidity rates (6.5% due to leaks). In our experience, leaks of the staple-line after sleeve gastrectomy (SG) are the most frequent sites of fistula formation and conservative treatment usually takes a long time. We present our experience in the treatment of gastric leaks with coated self-expandable stents (CSES). 6 patients had gastric leaks at the gastroesophageal (GE) junction after SG or DS. One patient had a symptomatic gastro-bronchial fistula. Stents were placed by the interventional radiologist under fluoroscopic control and removed endoscopically. In one case, we used an uncoated Wallstent. In two patients, percutaneous microcoil embolization of the fistula was added. The patient treated with the Wallstent required a total gastrectomy 6 months after placement of the uncovered stent. In the other 5 patients, coated stents were successfully removed and the gastric leaks completely sealed. CSES are proposed as an alternative therapeutic option for the management of GE junction leaks in bariatric surgery with good results in terms of morbidity and survival.

Fully covered self-expanding metal stents for refractory anastomotic colorectal strictures.

PubMed

Caruso, Angelo; Conigliaro, Rita; Manta, Raffaele; Manno, Mauro; Bertani, Helga; Barbera, Carmelo; Mirante, Vincenzo Giorgio; Frazzoni, Marzio

2015-05-01

Some patients with benign colorectal obstruction do not respond to endoscopic balloon dilation. Fully covered self-expandable metal stents (FCSEMSs) have several potential advantages over non-covered stents, including a higher likelihood of retrieval owing to limited local tissue reaction. However, the efficacy and safety of FCSEMSs in benign colorectal strictures have not yet been established. Retrospective analysis of prospectively collected data concerning patients with post-surgical benign symptomatic anastomotic colorectal strictures, refractory to endoscopic dilation and in whom FCSEMSs had been placed at our center. Technical success was defined as successful stent placement and deployment at the stricture site. Early clinical success was defined as symptom relief persisting at least for 3 days. Follow-up was based on monthly clinical evaluation and quarterly endoscopic assessment. Endoscopic stent removal was planned on the basis of clinical or endoscopic assessment. Prolonged clinical success was defined as persistent symptom relief during follow-up. Technical and early clinical success were obtained in 16 of 16 (100%) patients. The median follow-up was 21 months. Prolonged clinical success was achieved in 9/16 (56%) cases. There was no major complication, including perforation and bleeding. Stent migration occurred in 3 (19%) cases, in two of them associated with clinical failure. The median stent diameter was significantly higher in patients with successful than in those with unsuccessful clinical outcome (26 vs. 20 mm, P = 0.006). The clinical success rate was 1/6 (17%) in patients who received a 20-22 mm stent and 8/10 (80%) in those who received a 24-26 mm stent, respectively (P = 0.035). FCSEMSs can represent effective and safe treatment for refractory anastomotic colorectal strictures. Large diameter stents are warranted for better results.

Covered Metallic Stents With an Anti-Migration Design vs. Uncovered Stents for the Palliation of Malignant Gastric Outlet Obstruction: A Multicenter, Randomized Trial

PubMed Central

Lee, Hyuk; Min, Byung-Hoon; Lee, Jeong Hoon; Shin, Cheol Min; Kim, Younjoo; Chung, Hyunsoo; Lee, Sang Hyub

2015-01-01

OBJECTIVES: Previous studies reported comparable stent patency between covered self-expandable metallic stents (SEMS) and uncovered SEMS (UCS) for palliation of malignant gastric outlet obstruction (GOO). The aim of this study was to evaluate the efficacy and safety of the newly developed WAVE-covered SEMS (WCS), which has an anti-migration design, compared with UCS in gastric cancer patients with symptomatic GOO. METHODS: A total of 102 inoperable gastric cancer patients with symptomatic GOO were prospectively enrolled from five referral centers and randomized to undergo UCS or WCS placement. Stent patency and recurrence of obstructive symptoms were assessed at 8 weeks and 16 weeks after stent placement. RESULTS: At the 8-week follow-up, both stent patency rates (72.5% vs. 62.7%) and re-intervention rates (19.6% vs. 19.6%) were comparable between the WCS and the UCS groups. Both stent stenosis (2.4% vs. 8.1%) and migration rates (9.5% vs. 5.4%) were comparable between WCS and UCS groups. At the 16-week follow-up, however, the WCS group had a significantly higher stent patency rate than the UCS group (68.6% vs. 41.2%). Re-intervention rates in the WCS and UCS groups were 23.5% and 39.2%, respectively. Compared with the UCS group, the WCS group had a significantly lower stent restenosis rate (7.1% vs. 37.8%) and a comparable migration rate (9.5% vs. 5.4%). Overall stent patency was significantly longer in the WCS group than in the UCS group. No stent-associated significant adverse events occurred in either the WCS or UCS groups. In the multivariate analysis, WCS placement and chemotherapy were identified as independent predictors of 16-week stent patency. CONCLUSIONS: WCS group showed comparable migration rate and significantly more durable long-term stent patency compared with UCS group for the palliation of GOO in patients with inoperable gastric cancer. PMID:26372507

Stenting of the right ventricular outflow tract in 2 dogs for palliation of dysplastic pulmonary valve stenosis and right-to-left intracardiac shunting defects.

PubMed

Scansen, Brian A; Kent, Agnieszka M; Cheatham, Sharon L; Cheatham, John P; Cheatham, John D

2014-09-01

Two dogs with severe dysplastic pulmonary valve stenosis and right-to-left shunting defects (patent foramen ovale, perimembranous ventricular septal defect) underwent palliative stenting of the right ventricular outflow tract and pulmonary valve annulus using balloon expandable stents. One dog received 2 over-lapping bare metal stents placed 7 months apart; the other received a single covered stent. Both procedures were considered technically successful with a reduction in the transpulmonary valve pressure gradient from 202 to 90 mmHg in 1 dog and from 168 to 95 mmHg in the other. Clinical signs of exercise intolerance and syncope were temporarily resolved in both dogs. However, progressive right ventricular concentric hypertrophy, recurrent stenosis, and erythrocytosis were observed over the subsequent 6 months leading to poor long-term outcomes. Stenting of the right ventricular outflow tract is feasible in dogs with severe dysplastic pulmonary valve stenosis, though further study and optimization of the procedure is required. Copyright © 2014 Elsevier B.V. All rights reserved.

Prolonged high-pressure is required for optimal stent deployment as assessed by optical coherence tomography.

PubMed

Cook, Jeffrey R; Mhatre, Ajay; Wang, Fen Wei; Uretsky, Barry F

2014-03-01

Optimizing stent deployment is important for both acute- and long-term outcomes. High-pressure balloon inflation is the standard for coronary stent implantation. However, there is no standardized inflation protocol. We hypothesized that prolonged high-pressure balloon inflation until stabilization of inflation pressure is superior to a rapid inflation/deflation sequence for both stent expansion and strut apposition. A high-pressure rapid inflation/deflation sequence was deployed followed by angiography to assure no residual stenosis. Optical coherence tomography (OCT) was then performed followed by prolonged inflation until balloon pressure was stabilized for 30 sec using the same balloon at the same pressure as the rapid sequence. A second OCT run was then done. Thirteen thousand nine hundred thirteen stent struts were evaluated by OCT in 12 patients undergoing successful stenting. Stent expansion improved with prolonged (206 ± 115 sec) vs. rapid (28 ± 17 sec) inflation for both minimal stent diameter (3.0 ± 0.5 vs. 2.75 ± 0.44 mm, P < 0.0001) and area (7.83 ± 2.45 vs. 6.63 ± 1.85 mm(2) , P = 0.0003). The number of malapposed struts decreased (45 ± 41 vs. 88 ± 75, P = 0.005) as did the maximal malapposed strut distance (0.31 ± 0.2 vs. 0.43 ± 0.2 mm, P = 0.0001). Factors related to strut malapposition after rapid inflation included localized asymmetry in 67%, stent underexpansion in 75%, and stent undersizing in 67%. These data demonstrate that prolonged inflation is superior to a rapid inflation/deflation technique for both stent expansion and strut apposition. We recommend for routine stent deployment a prolonged inflation protocol as described above to optimize stent deployment. Copyright © 2012 Wiley Periodicals, Inc.

Coronary and peripheral stenting in aorto-ostial protruding stents: The balloon assisted access to protruding stent technique.

PubMed

Helmy, Tarek A; Sanchez, Carlos E; Bailey, Steven R

2016-03-01

Treatment of aorto-ostial in-stent restenosis lesions represents a challenge for interventional cardiologists. Excessive protrusion of the stent into the aorta may lead to multiple technical problems, such as difficult catheter reengagement of the vessel ostium or inability to re-wire through the stent lumen in repeat interventions. We describe a balloon assisted access to protruding stent technique in cases where conventional coaxial engagement of an aorto-ostial protruding stent with the guide catheter or passage of the guide wire through the true lumen is not feasible. This technique is applicable both in coronary and peripheral arteries. © 2015 Wiley Periodicals, Inc.

Management of occluded metal stents in malignant biliary obstruction: similar outcomes with second metal stents compared to plastic stents

PubMed Central

Shah, Tilak; Desai, Svetang; Haque, Mahfuzul; Dakik, Hassan; Fisher, Deborah

2013-01-01

Background Covered or uncovered self expandable metallic stents (SEMS) placed in patients with malignant biliary obstruction can occlude in 19–40%, but optimal management is unclear. Aim We sought to summarize current evidence regarding management of occluded SEMS in patients with malignant biliary obstruction. Methods Two investigators independently searched Pubmed, Embase, and Web of Science using pre-defined search criteria, and reviewed bibliographies of included studies. Data were independently abstracted by two investigators, and analyzed using RevMan. We compared strategies of second SEMS versus plastic stents with respect to the following outcomes: rate of second stent re-occlusion, duration of second stent patency, and survival. Results Ten retrospective studies met inclusion criteria for the systematic review. Management options described were placement of an uncovered SEMS (n=125), covered SEMS (n=106), plastic stent (n=135), percutaneous biliary drain (n=7), mechanical cleaning (n=18), or microwave coagulation (n=7). Relative risk of re-occlusion was not significantly different in patients with second SEMS compared to plastic stents (RR 1.24, 95% CI 0.92, 1.67, I2= 0, p 0.16). Duration of second stent patency was not significantly different between patients who received second SEMS versus plastic stents (weighted mean difference 0.46, 95% CI −0.30, 1.23, I2=83%). Survival was not significantly different among patients who received plastic stents versus SEMS (weighted mean difference −1.13, 95% CI −2.33, 0.07, I2 86%, p 0.07). Conclusions Among patients with malignant biliary obstruction and occluded SEMS, available evidence suggests a strategy of placing a plastic stent may be as effective as second SEMS. Limitations of these findings were that all studies were retrospective and heterogeneity between studies was detected for two of the outcomes. PMID:22732833

A new polymer-free drug-eluting stent with nanocarriers eluting sirolimus from stent-plus-balloon compared with bare-metal stent and with biolimus A9 eluting stent in porcine coronary arteries.

PubMed

Takimura, Celso K; Galon, Micheli Z; Gutierrez, Paulo S; Sojitra, Prakash; Vyas, Ashwin; Doshi, Manish; Lemos, Pedro A

2015-04-01

Permanent polymers in first generation drug-eluting stent (DES) have been imputed to be a possible cause of persistent inflammation, remodeling, malapposition and late stent thrombosis. We aim to describe the in vivo experimental result of a new polymer-free DES eluting sirolimus from stent-plus-balloon (Focus np stent, Envision Scientific) compared with a bare-metal stent (BMS) (Amazonia CroCo, Minvasys) and with a biolimus A9 eluting stent (Biomatrix, Biosensors). In 10 juvenile pigs, 23 coronary stents were implanted in the coronary arteries (8 Amazonia CroCo, 8 Focus np, and 7 Biomatrix). At 28-day follow-up, optical coherence tomography (OCT) and histology were used to evaluate neointimal hyperplasia and healing response. According to OCT analysis, Focus np stents had a greater lumen area and less neointimal hyperplasia response than BMS and Biomatrix had. Histomorphometry results showed less neointimal hyperplasia in Focus np than in BMS. Histology showed a higher fibrin deposition in Biomatrix stent compared to Focus np and BMS. The new polymer-free DES with sirolimus eluted from stent-plus-balloon demonstrated safety and reduced neointimal proliferation compared with the BMS and Biomatrix stents at 28-day follow-up in this porcine coronary model. This new polymer-free DES is promising and warrants further clinical studies.

Full covered self-expandable metal stents for the treatment of anastomotic leak using a silk thread

PubMed Central

Choi, Cheol Woong; Kang, Dae Hwan; Kim, Hyung Wook; Park, Su Bum; Kim, Su Jin; Hwang, Sun Hwi; Lee, Si Hak

2017-01-01

Abstract To evaluate the safety and effectiveness of fixation of the fully covered self-expandable metal stent (SEMS) placement using a silk thread for complete closure of an anastomotic leak. An anastomotic leak is a life-threatening complication after gastrectomy. Although the traditional treatment of choice was surgical re-intervention, an endoscopic SEMS can be used alternatively. During the study period, we retrospectively reviewed consecutive patients who received a modified covered SEMS capable of being fixed using a silk thread (Shim technique) due to an anastomotic leak after gastrectomy to prevent stent migration. Demographic data, stent placement and removal, clinical success, time to resolution, and complications were evaluated. A total of 7 patients underwent fully covered SEMS with a silk thread placement for an anastomotic leak after gastrectomy to treat gastric cancer. The patients’ mean age was 71.3 ± 8.0 years. Man sex was predominant (85.7%). All patients’ American Society of Anesthesiologists (ASA) scores were between I and III. Total gastrectomy was performed in 5 patients (71.4%) and proximal gastrectomy was performed in 2 patients (28.6%). The time between gastrectomy and stent insertion was 22.3 ± 11.1 days. The size of the leaks was 27.1 ± 11.1 mm. Technical success and complete leak closure were achieved in all patients. Stent migration was absent. All stents were removed between 4 and 6 weeks. Delayed esophageal stricture was found in 1 patient (14.2) and successfully resolved after endoscopic balloon dilation. For an anastomotic leak after gastrectomy, fully covered SEMS placement with a silk thread is an effective and safe treatment option without stent migration. The stent extraction time between 4 and 6 weeks was optimal without severe complications. PMID:28723752

Full covered self-expandable metal stents for the treatment of anastomotic leak using a silk thread.

PubMed

Choi, Cheol Woong; Kang, Dae Hwan; Kim, Hyung Wook; Park, Su Bum; Kim, Su Jin; Hwang, Sun Hwi; Lee, Si Hak

2017-07-01

To evaluate the safety and effectiveness of fixation of the fully covered self-expandable metal stent (SEMS) placement using a silk thread for complete closure of an anastomotic leak. An anastomotic leak is a life-threatening complication after gastrectomy. Although the traditional treatment of choice was surgical re-intervention, an endoscopic SEMS can be used alternatively.During the study period, we retrospectively reviewed consecutive patients who received a modified covered SEMS capable of being fixed using a silk thread (Shim technique) due to an anastomotic leak after gastrectomy to prevent stent migration. Demographic data, stent placement and removal, clinical success, time to resolution, and complications were evaluated.A total of 7 patients underwent fully covered SEMS with a silk thread placement for an anastomotic leak after gastrectomy to treat gastric cancer. The patients' mean age was 71.3 ± 8.0 years. Man sex was predominant (85.7%). All patients' American Society of Anesthesiologists (ASA) scores were between I and III. Total gastrectomy was performed in 5 patients (71.4%) and proximal gastrectomy was performed in 2 patients (28.6%). The time between gastrectomy and stent insertion was 22.3 ± 11.1 days. The size of the leaks was 27.1 ± 11.1 mm. Technical success and complete leak closure were achieved in all patients. Stent migration was absent. All stents were removed between 4 and 6 weeks. Delayed esophageal stricture was found in 1 patient (14.2) and successfully resolved after endoscopic balloon dilation.For an anastomotic leak after gastrectomy, fully covered SEMS placement with a silk thread is an effective and safe treatment option without stent migration. The stent extraction time between 4 and 6 weeks was optimal without severe complications.

Percutaneous Intraductal Radiofrequency Ablation for Extrahepatic Distal Cholangiocarcinoma: A Method for Prolonging Stent Patency and Achieving Better Functional Status and Quality of Life

DOE Office of Scientific and Technical Information (OSTI.GOV)

Wu, Tian-tian, E-mail: matthewwu1979@hotmail.com; Li, Wei-min, E-mail: weimin-li-surgery@126.com; Li, Hu-cheng, E-mail: hucheng-li-surgery@126.com

PurposeThe clinical efficacy of intraductal radiofrequency ablation (RFA) with Habib™ EndoHPB catheter, a newly developed intervention for malignant extrahepatic biliary obstruction, remains uncertain. The aim of this study was to investigate the clinical efficacy of intraductal RFA.MethodsData from 71 patients with extrahepatic distal cholangiocarcinoma were retrospectively analyzed. The study patients were divided into RFA and control groups. The RFA group had undergone percutaneous transhepatic intraductal RFA with a Habib™ EndoHPB catheter, followed by placement of covered or uncovered biliary self-expandable metallic stents (SEMs) whereas the control group had undergone percutaneous transhepatic covered or uncovered SEMs placement. Procedure-related complications, stent patency,more » patient survival, and postoperative serum bilirubin concentrations were compared between the two groups. The Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire was administered to evaluate functional status, improvement in clinical manifestations, and quality of life.ResultsThe RFA group had a longer median stent patency than the control group (p = 0.001 for uncovered SEMs placement). Higher functional well-being, hepatobiliary-specific cancer subscale, Trial Outcome Index, and total FACT-Hep scores were observed during post-procedure follow-up in the RFA group. However, median survival did not differ significantly between the two groups (p > 0.05).ConclusionsProlongation of stent patency and better functional status and quality of life, which are all important clinical endpoints, were observed in patients treated with intraductal RFA. Prospective randomized controlled clinical trials are necessary to further investigate the clinical efficacy and long-term benefits of intraductal RFA.« less

Bronchobiliary Fistula Treated by Self-expanding ePTFE-Covered Nitinol Stent-Graft

DOE Office of Scientific and Technical Information (OSTI.GOV)

Gandini, Roberto; Konda, Daniel; Tisone, Giuseppe

A 71-year-old man, who had undergone right hepatectomy extended to the caudate lobe with terminolateral Roux-en-Y left hepatojejunostomy for a Klatskin tumor, developed bilioptysis 3 weeks postoperatively due to bronchobiliary fistula. Percutaneous transhepatic cholangiography revealed a non-dilated biliary system with contrast medium extravasation to the right subphrenic space through a resected anomalous right posterior segmental duct. After initial unsuccessful internal-external biliary drainage, the fistula was sealed with a VIATORR covered self-expanding nitinol stent-graft placed with its distal uncovered region in the hepatojejunal anastomosis and the proximal ePTFE-lined region in the left hepatic duct. A 10-month follow-up revealed no recurrence ofmore » bilioptysis and confirmed the complete exclusion of the bronchobiliary fistula.« less

Mid-term Results of Endovascular Treatment for Infrarenal Aortic Stenosis and Occlusion.

PubMed

Sohgawa, Etsuji; Sakai, Yukimasa; Nango, Mineyoshi; Cho, Hisayuki; Jogo, Atsushi; Hamamoto, Shinichi; Yamamoto, Akira; Miki, Yukio

2015-06-01

Focal stenosis or occlusion of the infrarenal aorta is rare, and treatment is usually conventional bypass or endarterectomy. However, endovascular treatment has advanced in recent years. The purpose of this retrospective study is to report the results of primary stenting for focal infrarenal aortic occlusive disease and clarify the usefulness of endovascular treatment. This study includes 6 consecutive patients (3 men, 3 women; mean age, 59.3 years) with infrarenal aortic stenosis or occlusion who underwent endovascular intervention at our hospital between April 2009 and February 2014. All patients had bilateral intermittent claudication. The mean preoperative ankle-brachial index (ABI) showed a slight to moderate decrease: right 0.668 and left 0.636. The mean lesion site length was 12.5 mm, the percent stenosis was 90.7%, and calcification was present in 3 patients. Primary stenting was performed in all patients. The stent selected was generally a self-expanding stent (SES). For patients with severe calcification, the stent selected was a balloon-expandable stent (BES). Four patients received an SES and two patients received a BES. The technical success rate was 100%, no complications occurred, and the mean pressure gradient disappeared or decreased. Symptoms resolved in all patients and the postoperative ABI improved: right 0.923 and left 0.968. During a mean follow-up period of 27 months, there were no recurrent symptoms and no restenosis on CT angiography. Endovascular treatment should be considered as a first line treatment for focal infrarenal aortic stenosis and occlusion.

The Glider registry.

PubMed

Secco, Gioel Gabrio; Rittger, Harald; Hoffmann, Stefan; Richardt, Gert; Abdel-Wahab, Mohamed; Reinecke, Holger; Lotan, Chaim; Werner, Gerald; Sievert, Horst; Foin, Nicolas; Di Mario, Carlo

2017-01-01

Provisional stenting of the side-branch (SB) is the universally accepted gold standard while there is still controversy on the usefulness of routine dilatation of the SB ostium. Recrossing the struts of a previously deployed stent with a wire and a balloon can prove challenging and is occasionally unsuccessful, mainly because the balloon tip hits a stent strut. This prospective multicenter international registry tested the crossing ability procedural results of a new-dedicated ultrashort balloon specifically designed for side branch dilatation (Glider, TriReme Medical, Pleasanton, CA, USA). One hundred and twenty five patients (for a total of 131 bifurcation lesions) were enrolled in the registry between January 2009 and May 2012. The Glider was used as first choice in alternative to conventional balloon (group I, 72%) or as bail-out after unsuccessful previous attempt at crossing with small conventional low-profile balloons (group II, 28%). Postprocedural coronary artery dissections and in-hospital MACE (death, myocardial infarction and repeat revascularization) were assessed. Technical success was defined as the ability of the Glider to recross the struts of a previously deployed stent while procedural success was defined as less of residual 50% diameter stenosis at the origin of the SB with a final TIMI 3 and/or freedom from in-hospital MACE. Technical success was achieved, respectively, in 92% (group I), and 83% (group II). Clinical and angiographic procedural success was achieved in 98% of the lesions. In Group II, no other balloon of the same size could cross in cases where Glider could not. A total of 13 complications were observed, including nine ostial SB dissection four of which needed a second stent on the SB, one stent loss, two severe coronary spasms, and two by thrombus formation. The unique possibility offered by this short dedicated balloon to orientate its beveled tip provides an effective strategy for recrossing stent struts when conventional low profile balloons fail achieving greater SB ostial expansion thus reducing the incidence of strut malapposition during provisional treatment of bifurcational lesions. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Choledochoscopic high-frequency needle-knife electrotomy for treatment of anastomotic strictures after Roux-en-Y hepaticojejunostomy.

PubMed

Yang, Yu-Long; Zhang, Cheng; Wu, Ping; Ma, Yue-Feng; Li, Jing-Yi; Zhang, Hong-Wei; Shi, Li-Jun; Lin, Mei-Ju; Yu, Ying

2016-05-06

Anastomotic stricture is a complex and substantial complication following Roux-en-Y hepaticojejunostomy. Initially, endoscopic and percutaneous approaches are often attempted, but the gold standard remains surgical biliary reconstruction, especially for refractory stricture. However, this solution leaves much room for improvement, due to the challenging nature of the biliary reconstruction procedure, in which anastomotic stricture may still occur. To investigate the feasibility and effectiveness of choledochoscopic high-frequency needle-knife electrotomy as an intervention in the treatment of anastomotic strictures following Roux-en-Y hepaticojejunostomy. From February 2010 to October 2014, clinical data was collected and retrospectively compared for patients who underwent balloon dilation or/and choledochoscopic high-frequency needle-knife electrotomy for the treatment of anastomotic strictures after Roux-en-Y hepaticojejunostomy. A total of 38 patients underwent successful choledochoscopic treatment and all the anastomotic strictures were removed successfully, 19 of which were treated with electrotomy, 7 with balloon dilation, and 12 with both electrotomy and balloon dilation. Among these groups,the average operating times were 6.9 ± 2.4 min,10.1 ± 6.8 min, and 20.2 ± 13.5 min, respectively. The average stent supporting times were 6.3 ± 0.7 months, 6.5 ± 0.6 months, and 6.1 ± 0.4 respectively. The mean follow-up after stent removal was 42.1 ± 27.4 months, and in 26.3 % (5/19), 28.5 % (2/7) and 16.7 % (2/12) of cases, recurrent anastomotic stricture occurred. Of these 9 total patients with recurrent anastomotic, two patients were successfully rescued by full-covered self-expanding removable metal stents and 7 patients by electrotomy combined with balloon dilation. Choledochoscopic high-frequency needle-knife electrotomy is both feasible and safe in the treatment of anastomotic stricture after Roux-en-Y hepaticojejunostomy, with a similar long-term outcome to balloon dilation in treating anastomotic stricture after Roux-en-Y hepaticojejunostomy. A combination of choledochoscopic electrotomy concurrent with balloon dilation should be recommended based on the low rate of recurrence.

A computational study of crimping and expansion of bioresorbable polymeric stents

NASA Astrophysics Data System (ADS)

Qiu, T. Y.; Song, M.; Zhao, L. G.

2018-05-01

This paper studied the mechanical performance of four bioresorbable PLLA stents, i.e., Absorb, Elixir, Igaki-Tamai and RevaMedical, during crimping and expansion using the finite element method. Abaqus CAE was used to create the geometrical models for the four stents. A tri-folded balloon was created using NX software. For the stents, elastic-plastic behaviour was used, with hardening implemented by considering the increase of yield stress with the plastic strain. The tri-folded balloon was treated as linear elastic. To simulate the crimping of stents, a set of 12 rigid plates were generated around the stents with a radially enforced displacement. During crimping, the stents were compressed from a diameter of 3 mm to 1.2 mm, with the maximum stress developed at both inner and outer sides of the U-bends. During expansion, the stent inner diameter increased to 3 mm at the peak pressure and then recoiled to different final diameters after balloon deflation due to different stent designs. The maximum stress was found again at the U-bends of stents. Diameter change, recoiling effect and radial strength/stiffness were also compared for the four stents to assess the effect of design variation on stent performance. The effect of loading rate on stent deformation was also simulated by considering the time-dependent plastic behaviour of polymeric material.

A computational study of crimping and expansion of bioresorbable polymeric stents

NASA Astrophysics Data System (ADS)

Qiu, T. Y.; Song, M.; Zhao, L. G.

2017-10-01

This paper studied the mechanical performance of four bioresorbable PLLA stents, i.e., Absorb, Elixir, Igaki-Tamai and RevaMedical, during crimping and expansion using the finite element method. Abaqus CAE was used to create the geometrical models for the four stents. A tri-folded balloon was created using NX software. For the stents, elastic-plastic behaviour was used, with hardening implemented by considering the increase of yield stress with the plastic strain. The tri-folded balloon was treated as linear elastic. To simulate the crimping of stents, a set of 12 rigid plates were generated around the stents with a radially enforced displacement. During crimping, the stents were compressed from a diameter of 3 mm to 1.2 mm, with the maximum stress developed at both inner and outer sides of the U-bends. During expansion, the stent inner diameter increased to 3 mm at the peak pressure and then recoiled to different final diameters after balloon deflation due to different stent designs. The maximum stress was found again at the U-bends of stents. Diameter change, recoiling effect and radial strength/stiffness were also compared for the four stents to assess the effect of design variation on stent performance. The effect of loading rate on stent deformation was also simulated by considering the time-dependent plastic behaviour of polymeric material.

Comparison of Covered Versus Uncovered Stents for Benign Superior Vena Cava (SVC) Obstruction.

PubMed

Haddad, Mustafa M; Simmons, Benjamin; McPhail, Ian R; Kalra, Manju; Neisen, Melissa J; Johnson, Matthew P; Stockland, Andrew H; Andrews, James C; Misra, Sanjay; Bjarnason, Haraldur

2018-05-01

To identify whether long-term symptom relief and stent patency vary with the use of covered versus uncovered stents for the treatment of benign SVC obstruction. We retrospectively identified all patients with benign SVC syndrome treated to stent placement between January 2003 and December 2015 (n = 59). Only cases with both clinical and imaging follow-up were included (n = 47). In 33 (70%) of the patients, the obstruction was due to a central line or pacemaker wires, and in 14 (30%), the cause was fibrosing mediastinitis. Covered stents were placed in 17 (36%) of the patients, and 30 (64%) patients had an uncovered stent. Clinical and treatment outcomes, complications, and the percent stenosis of each stent were evaluated. Technical success was achieved in all cases at first attempt. Average clinical and imaging follow-up in years was 2.7 (range 0.1-11.1) (covered) and 1.7 (range 0.2-10.5) (uncovered), respectively. There was a significant difference (p = 0.044) in the number of patients who reported a return of symptoms between the covered (5/17 or 29.4%) and uncovered (18/30 or 60%) groups. There was also a significant difference (p = < 0.001) in the mean percent stenosis after stent placement between the covered [17.9% (range 0-100) ± 26.2] and uncovered [48.3% (range 6.8-100) ± 33.5] groups. No significant difference (p = 0.227) was found in the time (days) between the date of the procedure and the date of clinical follow-up where a return of symptoms was reported [covered: 426.6 (range 28-1554) ± 633.9 and uncovered 778.1 (range 23-3851) ± 1066.8]. One patient in the uncovered group had non-endovascular surgical intervention (innominate to right atrial bypass), while none in the covered group required surgical intervention. One major complication (SIR grade C) occurred that consisted of a pericardial hemorrhagic effusion after angioplasty that required covered stent placement. There were no procedure-related deaths. Both covered and uncovered stents can be used for treating benign SVC syndrome. Covered stents, however, may be a more effective option at providing symptom relief and maintaining stent patency if validated by further studies.

Efficacy and Safety of Endovascular Intervention for the Management of Primary Entire-Inferior Vena Cava Occlusion

DOE Office of Scientific and Technical Information (OSTI.GOV)

Zhang, Qingqiao, E-mail: 1427286069@qq.com; Huang, Qianxin, E-mail: 18705206105@163.com; Shen, Bin, E-mail: 753021357@qq.com

PurposeThis study was designed to investigate the safety and efficacy of endovascular intervention for the treatment of primary entire-inferior vena cava (IVC) occlusion.MethodsEndovascular interventions were performed in six patients for the treatment of primary entire-IVC occlusion. IVC and hepatic venography were performed via the jugular and femoral veins. Balloon angioplasty was used to revascularize the hepatic vein and IVC and a stent was placed in the IVC to maintain patency. Postoperative color Doppler ultrasonography was performed at 1, 3, 6, and 12 months, and then annually, to monitor the patency of the hepatic vein and IVC.ResultsThe IVC and one or twomore » hepatic veins were successfully revascularized in five patients. Revascularization was successful in the right and left hepatic veins in one patient; however, IVC patency could not be established in this patient. Eleven Z-type, self-expanding stents were placed into the IVCs of five patients (three stents in two patients, two stents in two patients, and one stent in one patient). There were no instances of postoperative bleeding or mortality. Follow-up was conducted for 18–90 months (42.8 ± 26.5 months). None of the five patients suffered restenosis of the IVC or hepatic veins. However, there was one of the six cases of right hepatic vein restenosis at 18 months postprocedure that was revascularized after a second balloon dilatation.ConclusionsEndovascular intervention is safe and efficacious for the treatment of primary entire-IVC occlusion.« less

Visceral Blood Flow Modulation: Potential Therapy for Morbid Obesity

DOE Office of Scientific and Technical Information (OSTI.GOV)

Harris, Tyler J., E-mail: tjharris@gmail.com; Murphy, Timothy P.; Jay, Bryan S.

We present this preliminary investigation into the safety and feasibility of endovascular therapy for morbid obesity in a swine model. A flow-limiting, balloon-expandable covered stent was placed in the superior mesenteric artery of three Yorkshire swine after femoral arterial cutdown. The pigs were monitored for between 15 and 51 days after the procedure and then killed, with weights obtained at 2-week increments. In the two pigs in which the stent was flow limiting, a reduced rate of weight gain (0.42 and 0.53 kg/day) was observed relative to the third pig (0.69 kg/day), associated with temporary food aversion and signs ofmore » mesenteric ischemia in one pig.« less

A new polymer-free drug-eluting stent with nanocarriers eluting sirolimus from stent-plus-balloon compared with bare-metal stent and with biolimus A9 eluting stent in porcine coronary arteries

PubMed Central

Galon, Micheli Z.; Gutierrez, Paulo S.; Sojitra, Prakash; Vyas, Ashwin; Doshi, Manish; Lemos, Pedro A.

2015-01-01

Background Permanent polymers in first generation drug-eluting stent (DES) have been imputed to be a possible cause of persistent inflammation, remodeling, malapposition and late stent thrombosis. We aim to describe the in vivo experimental result of a new polymer-free DES eluting sirolimus from stent-plus-balloon (Focus np stent, Envision Scientific) compared with a bare-metal stent (BMS) (Amazonia CroCo, Minvasys) and with a biolimus A9 eluting stent (Biomatrix, Biosensors). Methods In 10 juvenile pigs, 23 coronary stents were implanted in the coronary arteries (8 Amazonia CroCo, 8 Focus np, and 7 Biomatrix). At 28-day follow-up, optical coherence tomography (OCT) and histology were used to evaluate neointimal hyperplasia and healing response. Results According to OCT analysis, Focus np stents had a greater lumen area and less neointimal hyperplasia response than BMS and Biomatrix had. Histomorphometry results showed less neointimal hyperplasia in Focus np than in BMS. Histology showed a higher fibrin deposition in Biomatrix stent compared to Focus np and BMS. Conclusions The new polymer-free DES with sirolimus eluted from stent-plus-balloon demonstrated safety and reduced neointimal proliferation compared with the BMS and Biomatrix stents at 28-day follow-up in this porcine coronary model. This new polymer-free DES is promising and warrants further clinical studies. PMID:25984451

Acute stent recoil and optimal balloon inflation strategy: an experimental study using real-time optical coherence tomography.

PubMed

Kitahara, Hideki; Waseda, Katsuhisa; Yamada, Ryotaro; Otagiri, Kyuhachi; Tanaka, Shigemitsu; Kobayashi, Yuhei; Okada, Kozo; Kume, Teruyoshi; Nakagawa, Kaori; Teramoto, Tomohiko; Ikeno, Fumiaki; Yock, Paul G; Fitzgerald, Peter J; Honda, Yasuhiro

2016-06-12

Our aim was to evaluate stent expansion and acute recoil at deployment and post-dilatation, and the impact of post-dilatation strategies on final stent dimensions. Optical coherence tomography (OCT) was performed on eight bare metal platforms of drug-eluting stents (3.0 mm diameter, n=6 for each) during and after balloon inflation in a silicone mock vessel. After nominal-pressure deployment, a single long (30 sec) vs. multiple short (10 sec x3) post-dilatations were performed using a non-compliant balloon (3.25 mm, 20 atm). Stent areas during deployment with original delivery systems were smaller in stainless steel stents than in cobalt-chromium and platinum-chromium stents (p<0.001), whereas subsequent acute recoil was comparable among the three materials. At post-dilatation, acute recoil was greater in cobalt-chromium and platinum-chromium stents than in stainless steel stents (p<0.001), resulting in smaller final stent areas in cobalt-chromium and platinum-chromium stents than in stainless steel stents (p<0.001). In comparison between conventional and latest-generation cobalt-chromium stents, stent areas were not significantly different after both deployment and post-dilatation. With multiple short post-dilatations, acute recoil was significantly improved from first to third short inflation (p<0.001), achieving larger final area than a single long inflation, despite stent materials/designs (p<0.001). Real-time OCT revealed significant acute recoil in all stent types. Both stent materials/designs and post-dilatation strategies showed a significant impact on final stent expansion.

In vitro fenestration of aortic stent-grafts: implications of puncture methods for in situ fenestration durability.

PubMed

Riga, Celia V; Bicknell, Colin D; Basra, Melvinder; Hamady, Mohamad; Cheshire, Nicholas J W

2013-08-01

To investigate the quality of stent-graft fenestrations created in vitro using different needle puncture and balloon dilation angles in different commercial endografts. Fenestrations were made in a standardized fashion in 3 different endograft types: Talent monofilament twill woven polyester, Zenith multifilament tubular woven polyester, and Endofit thin-walled expanded polytetrafluoroethylene (PTFE). Punctures were made at 30°, 60°, and 90° angles using a 20-G needle and dilated using 6-mm standard and 7-mm cutting balloons; at least 6 fenestrations were made at each angle with standard balloons and at least 6 with cutting balloons. The 137 fenestrations were examined under light microscopy; quantitative and qualitative digital image analysis was performed to determine size, shape, and fenestration quality. PTFE grafts were easier to puncture/dilate, resulting in larger, elliptical fenestrations with overall better quality than the Dacron grafts; however, the puncture/dilation angle made an impact on the shape and quality of fenestrations. A significant number of fabric tears were observed in PTFE fabric at <90° puncture/dilation angles compared to Dacron grafts. In Dacron grafts, fenestration quality was significantly higher with 90° puncture/dilation angles (higher in Talent grafts). Cutting balloon use resulted in significantly more fabric tears and poor quality fenestrations in all graft types. Different endografts behave significantly differently when fenestrations are fashioned. Optimum puncture/dilation is important when considering in vivo fenestration techniques. Improvements in instrumentation, materials, and techniques are required to make this a reliable and reproducible endovascular option.

Direct stenting versus balloon predilation: Jury is still out.

PubMed

Belardi, Jorge A; Albertal, Mariano

2017-08-01

Compared to balloon predilation, direct stenting (DS) shortens procedural time and reduces radiation and contrast exposure. A meta-analysis that included 7 studies comparing these 2 strategies revealed lower adverse event rate with DS. Studies included in the present meta-analysis were mostly observational and utilized first generation drug-eluting stent. Patient and lesion selection may explain these positive results. © 2017 Wiley Periodicals, Inc.

In-Graft Endovascular Stenting Repair for Supravalvular Stenosis From Aortic Rupture After Balloon-Expanding Transcatheter Aortic Valve Implantation.

PubMed

Furukawa, Nobuyuki; Scholtz, Werner; Haas, Nikolaus; Ensminger, Stephan; Gummert, Jan; Börgermann, Jochen

2015-01-01

An 81-year-old man with high-grade aortic valve stenosis and status post-coronary artery bypass grafting and supracoronary replacement of the ascending aorta was referred for transcatheter aortic valve implantation. He was in New York Heart Association class III and had dyspnea. After appropriate screening, we implanted a 29-mm SAPIEN XT valve (Edwards Lifesciences, Irvine, CA USA) through a transapical approach because of severe peripheral arterial occlusive disease. Postinterventional aortography revealed correct positioning and function of the valve and free coronary ostia but contrast extravasation in the vicinity of the interposed vascular prosthesis, resulting in severe luminal narrowing. We chose to manage the stenosis with an endovascular stent. After stenting, extravascular compression was markedly reduced, and the pressure gradient disappeared. The patient was discharged home on the 20th postoperative day. Three months later, computed tomography depicted correct positioning of both grafts. The patient's general health is good, and he is now in New York Heart Association class II. This case illustrates a complication of transcatheter aortic valve implantation specific for patients with an ascending aortic graft. Although stenting may be a good solution, as depicted by this case, self-expanding transcatheter aortic valves should be preferred in patients with ascending aortic grafts to avoid the described complication.

[Migration of a stent implanted in the pulmonary artery of a patient with tetralogy of Fallot].

PubMed

Palomero Rodríguez, M A; Gabaldón Rivilla, M; Cabestrero Alonso, D; Gonzalez Cibrián, C; Abelleira Pardeiro, C; Centella Hernánez, T; Collado Gutierrez, R; Asuero de Lis, M S; Gómez González, R

2014-05-01

Tetralogy of Fallot is a congenital heart disease that accounts for 11-13% of the congenital cardiomyopathies. Stenosis and hyperplasia of the pulmonary arteries occur in a high proportion of them as this disease causes a native stenosis of the pulmonary branch, which can be surgically repaired with a stent. The use of balloon expandable intravascular stents is an alternative technique to further surgery in patients with congenital heart diseases. However, despite the gradual increase in their use, the limited number of procedures, combined with the wide anatomical variability and different characteristics of these patients, even in expert hands, stent implants are associated with a not inconsiderable incidence of complications. These are not always obvious and often require performing surgery in patients who have already had multiple interventions, thus increasing the complexity and the risk. Copyright © 2013 Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor. Published by Elsevier España. All rights reserved.

Delayed Development of Brain Abscesses Following Stent-Graft Placement in a Head and Neck Cancer Patient Presenting with Carotid Blowout Syndrome

DOE Office of Scientific and Technical Information (OSTI.GOV)

Oweis, Yaseen; Gemmete, Joseph J., E-mail: gemmete@umich.edu; Chaudhary, Neeraj

2011-02-15

We describe the delayed development of intracranial abscesses following emergent treatment with a covered stent-graft for carotid blowout syndrome (CBS) in a patient with head and neck cancer. The patient presented with hemoptysis and frank arterial bleeding through the tracheostomy site. A self-expandable stent-graft was deployed across a small pseudoaneurysm arising from the right common carotid artery (RCCA) and resulted in immediate hemostasis. Three months later, the patient suffered a recurrent hemorrhage. CT of the neck demonstrated periluminal fluid around the caudal aspect of the stent-graft with intraluminal thrombus and a small pseudoaneurysm. Subsequently, the patient underwent a balloon testmore » occlusion study and endovascular sacrifice of the RCCA and right internal carotid artery. MRI of the brain demonstrated at least four ring-enhancing lesions within the right cerebral hemisphere consistent with intracranial abscesses that resolved with broad-spectrum antibiotic coverage.« less

Self-expandable metal stents for malignant esophageal obstruction: a comparative study between extrinsic and intrinsic compression.

PubMed

Rhee, K; Kim, J-H; Jung, D H; Han, J W; Lee, Y C; Lee, S K; Shin, S K; Park, J C; Chung, H S; Park, J J; Youn, Y H; Park, H

2016-04-01

Self-expandable metal stents (SEMSs) are effective for malignant esophageal obstruction, but usefulness of SEMSs in extrinsic lesions is yet to be elucidated. This study is aimed at evaluating the clinical usefulness of SEMSs in the extrinsic compression compared with intrinsic. A retrospective review was conducted for 105 patients (intrinsic, 85; extrinsic, 20) with malignant esophageal obstruction who underwent endoscopic SEMSs placement. Technical and clinical success rates were evaluated and clinical outcomes were compared between extrinsic and intrinsic group. Extrinsic group was mostly pulmonary origin. Overall technical and clinical success rate was 100% and 91%, respectively, without immediate complications. Extrinsic and intrinsic group did not differ significantly in clinical success rate. The median stent patency time was 131.3 ± 85.8 days in intrinsic group while that of extrinsic was 54.6 ± 45.1 due to shorter survival after stent insertion. The 4-, 8-, and 12-week patency rates were 90.5%, 78.8%, and 64.9% respectively in intrinsic group, while stents of extrinsic group remained patent until death. Uncovered, fully covered, and double-layered stent were used evenly and the types did not influence patency in both groups. In conclusion, esophageal SEMSs can safely and effectively be used for malignant extrinsic compression as well as intrinsic. © 2015 International Society for Diseases of the Esophagus.

Management of acute cholangitis as a result of occlusion from a self-expandable metallic stent in patients with malignant distal and hilar biliary obstructions.

PubMed

Shiomi, Hideyuki; Matsumoto, Kazuya; Isayama, Hiroyuki

2017-04-01

Acute cholangitis as a result of common bile duct stones can be managed; however, cholangitis caused by occlusion with a biliary self-expandable metallic stent (SEMS) in patients with an unresectable malignant biliary obstruction has not been fully discussed. The acute cholangitis clinical guidelines (Tokyo Guidelines 2013) recommend following the same procedure as that used for cholangitis; however, the patient's condition, including performance status, tumor extension or staging, and prognosis must be considered. Most physicians manage cholangitis from a SEMS occlusion using a two-step procedure. They insert endoscopic drainage with a plastic stent or insert a nasobiliary drainage tube, which does not exacerbate sepsis. Addition or replacement of a biliary SEMS is required in many cases depending on the cause of the occlusion. Tumor ingrowth through the stent mesh is common in uncovered SEMS and requires placement of another stent in an in-stent method. However, covered SEMS tends to be occluded by sludge, so it must be replaced because of the bacterial biofilm that forms on the covering membrane. The location of the biliary stricture (hilar or distal) should also be considered. Strategies for managing cholangitis as a result of occlusion by a biliary SEMS remain controversial, so prospective clinical trials are needed. © 2017 The Authors. Digestive Endoscopy © 2017 Japan Gastroenterological Endoscopy Society.

Drug-Coated Balloon Angioplasty: A Novel Treatment for Pulmonary Artery In-Stent Stenosis in a Patient with Williams Syndrome.

PubMed

Cohen, Jennifer L; Glickstein, Julie S; Crystal, Matthew A

2017-12-01

A 20-month-old boy with Williams syndrome had undergone multiple surgical and catheter-based interventions for resistant peripheral pulmonary arterial stenoses with eventual bilateral stent placement and conventional balloon angioplasty. He persistently developed suprasystemic right ventricular (RV) pressure. Angioplasty with a drug-coated balloon (DCB) was performed for in-stent restenosis and to remodel his distal pulmonary vessels bilaterally. This resulted in immediate improvement in the in-stent stenosis and resultant decrease in RV pressure. Follow-up catheterization two months later continued to show long-lasting improvement in the in-stent stenosis. We hypothesize that the anti-proliferative effects of DCBs may be of benefit in the arteriopathy associated with Williams syndrome. We report this as a novel use of a DCB in the pulmonary arterial circulation in a patient with Williams syndrome.

High single-session success rate of endoscopic bilateral stent-in-stent placement with modified large cell Niti-S stents for malignant hilar biliary obstruction.

PubMed

Kogure, Hirofumi; Isayama, Hiroyuki; Nakai, Yousuke; Tsujino, Takeshi; Matsubara, Saburo; Yashima, Yoko; Ito, Yukiko; Hamada, Tsuyoshi; Takahara, Naminatsu; Miyabayashi, Koji; Mizuno, Suguru; Mohri, Dai; Kawakubo, Kazumichi; Sasaki, Takashi; Yamamoto, Natsuyo; Hirano, Kenji; Sasahira, Naoki; Tada, Minoru; Koike, Kazuhiko

2014-01-01

Endoscopic bilateral self-expandable metallic stent (SEMS) placement in a stent-in-stent method for malignant hilar biliary obstruction is technically challenging. Technical difficulties in the initial placement and reinterventions for stent occlusion are disadvantages inherent to this stent-in-stent method. We previously reported the feasibility of Niti-S large cell D-type biliary stents (LCD). This multicenter prospective consecutive study evaluated the efficacy of bilateral SEMS placement using modified LCD with large and uniform cells, a slimmer delivery system and high radial force. From July 2010 to June 2011, 26 consecutive patients with unresectable malignant hilar biliary obstruction underwent endoscopic bilateral placement of modified LCD in a stent-in-stent method at three tertiary hospitals. Ten patients had gallbladder cancer, eight had cholangiocarcinoma, four had lymph node metastasis, two had intrahepatic cholangiocarcinoma, and two had liver metastasis. Single-session and final technical success rate was 96% and 100%, respectively. Functional success rate was 89%. Stent occlusion occurred in 11 patients (42%) because of sludge (n = 7) or tumor ingrowth (n = 4). Endoscopic bilateral reintervention was technically easy and successful: six patients had stent clearance by balloon sweeping and five had plastic stent placement. According to Kaplan-Meier analysis, median survival and stent patency were 220 days and 157 days, respectively. Modified LCD achieved a high technical success rate both in the initial stent-in-stent placement and in bilateral reinterventions in patients with malignant hilar biliary obstruction. © 2013 The Authors. Digestive Endoscopy © 2013 Japan Gastroenterological Endoscopy Society.

Fabrication and in vitro deployment of a laser-activated shape memory polymer vascular stent

PubMed Central

Baer, Géraldine M; Small, Ward; Wilson, Thomas S; Benett, William J; Matthews, Dennis L; Hartman, Jonathan; Maitland, Duncan J

2007-01-01

Background Vascular stents are small tubular scaffolds used in the treatment of arterial stenosis (narrowing of the vessel). Most vascular stents are metallic and are deployed either by balloon expansion or by self-expansion. A shape memory polymer (SMP) stent may enhance flexibility, compliance, and drug elution compared to its current metallic counterparts. The purpose of this study was to describe the fabrication of a laser-activated SMP stent and demonstrate photothermal expansion of the stent in an in vitro artery model. Methods A novel SMP stent was fabricated from thermoplastic polyurethane. A solid SMP tube formed by dip coating a stainless steel pin was laser-etched to create the mesh pattern of the finished stent. The stent was crimped over a fiber-optic cylindrical light diffuser coupled to an infrared diode laser. Photothermal actuation of the stent was performed in a water-filled mock artery. Results At a physiological flow rate, the stent did not fully expand at the maximum laser power (8.6 W) due to convective cooling. However, under zero flow, simulating the technique of endovascular flow occlusion, complete laser actuation was achieved in the mock artery at a laser power of ~8 W. Conclusion We have shown the design and fabrication of an SMP stent and a means of light delivery for photothermal actuation. Though further studies are required to optimize the device and assess thermal tissue damage, photothermal actuation of the SMP stent was demonstrated. PMID:18042294

Impact of peri-stent remodeling on restenosis: a volumetric intravascular ultrasound study.

PubMed

Nakamura, M; Yock, P G; Bonneau, H N; Kitamura, K; Aizawa, T; Tamai, H; Fitzgerald, P J; Honda, Y

2001-05-01

Vessel remodeling is an important mechanism of late lumen loss after nonstent coronary interventions. However, its impact on in-stent restenosis has not been systematically investigated. Serial volumetric intravascular ultrasound analyses (poststent and follow-up) were performed in 55 lesions treated with a balloon-expandable stent (ACS MultiLink) using standard stent deployment techniques. The vessel volume (VV), lumen volume (LV), and volume bordered by the stent (SV) were measured using Simpson's method. The volume of plaque and neointima outside the stent (peri-stent volume, PSV) and volume of neointima within the stent (intrastent volume) were also measured. The change of each parameter during the follow-up period (follow-up minus poststent) was calculated and then divided by SV to normalize these values (designated as percent change [%]). As expected, %PSV directly correlated with %VV (P<0.0001, r=0.935), with no significant SV. A highly significant inverse correlation was seen between %PSV and the percent change of intrastent volume (P<0.0001, r=0.517). Consequently, %LV significantly correlated with peri-stent remodeling, as measured by %VV (P<0.0001, r=0.602). Positive remodeling of the vessel exterior to a coronary stent occurs to a variable degree after stent implantation. There is a distinct trade-off between positive remodeling and in-stent hyperplasia: in segments in which the degree of peri-stent remodeling is less, intrastent neointimal proliferation is greater and accompanied by more significant late lumen loss.

Are drug-coated balloons cost effective for femoropopliteal occlusive disease? A comparison of bare metal stents and uncoated balloons.

PubMed

Poder, Thomas G; Fisette, Jean-François

2016-07-01

To perform a cost-effectiveness analysis to help hospital decision-makers with regard to the use of drug-coated balloons compared with bare metal stents and uncoated balloons for femoropopliteal occlusive disease. Clinical outcomes were extracted from the results of meta-analyses already published, and cost units are those used in the Quebec healthcare network. The literature review was limited to the last four years to obtain the most recent data. The cost-effectiveness analysis was based on a 2-year perspective, and risk factors of reintervention were considered. The cost-effectiveness analysis indicated that drug-coated balloons were generally more efficient than bare metal stents, particularly for patients with higher risk of reintervention (up to CAD$1686 per patient TASC II C or D). Compared with uncoated balloons, results indicated that drug-coated balloons were more efficient if the reintervention rate associated with uncoated balloons is very high and for patients with higher risk of reintervention (up to CAD$3301 per patient). The higher a patient's risk of reintervention, the higher the savings associated with the use of a drug-coated balloon will be. For patients at lower risk, the uncoated balloon strategy is still recommended as a first choice for endovascular intervention.

Bioresorbable vascular scaffolds for LMCA with double vessel disease under IVUS guidance.

PubMed

Kasturi, Sridhar; Vilvanathan, Vinoth Kumar

2015-12-01

An 80-year-old male patient, presented with chest pain. ECG showed ST elevation in leads V2 to V4 and T wave inversion in leads V2-V6. Check angiogram revealed ostial LMCA 70% lesion & mid-LAD 90% lesion and LCX proximal 80% lesion. Predilatation of LMCA lesion was done with 2.0 × 12 mm NC Trek balloon and the LAD lesion with 2.0 × 12 mm and 2.5 × 08 mm (NC Trek balloons). Prestenting IVUS (Intravascular ultrasound) was done with Atlantis SR pro 40 MHz 3.6 Fr catheter. IVUS showed the LAD to have a minimal lumen area of 2.6 sq mm with 90% fibrotic plaque and a vessel size of 2.5mm and the LMCA to have a minimal lumen area of 8.8 sq mm with 70% fibrotic plaque and vessel size of 3.8mm. Mid-LAD stenting was done with 2.5 × 28 mm Absorb Stent (BVS). Predilatation of LCX lesion was done with 2.5 × 08 mm NC Trek balloon. Then stenting was performed with 3.0 × 28 mm Absorb Stent (BVS). Check angiogram showed edge dissection proximal to the BVS Stent which was covered with 3.0 × 12 mm Xience Xpedtion Stent (DES). Then LMCA Stenting was done with 3.5 × 12 mm Absorb Stent. Post dilatation was done with 4.0 × 08 mm NC Trek balloon. Post Stenting LMCA - LAD IVUS was done. LMCA and LAD Stents were well opposed without any dissection or residual stenosis. TIMI III Flow was achieved in the final results. Copyright © 2015 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.

Colonic strictures: dilation and stents.

PubMed

Adler, Douglas G

2015-04-01

Colonic strictures, both benign and malignant, are commonly encountered in clinical practice. Benign strictures are most commonly treated by balloon dilation and less frequently with stents. Balloon dilation can help forestall or obviate surgery in some patients. Colonic strictures of malignant etiology generally need to be managed by stents and/or surgery. This article reviews endoscopic approaches to the management of colonic strictures. Copyright © 2015 Elsevier Inc. All rights reserved.

Argon plasma coagulation in the management of uncovered tracheal stent fracture

PubMed Central

Ching, Yiu-Hei; Geck, Robert D.; Andrews, Arthur D.; Rumbak, Mark J.; Camporesi, Enrico M.

2014-01-01

Endotracheal and endobronchial stenting, particularly with uncovered stents, can be complicated by stent fracture, granulation tissue formation, direct airway injury, and airway obstruction. While stent removal is possible, it can result in significant complications and long-term benefit is not guaranteed. Argon plasma coagulation can be employed to trim fractured stent fragments and remove granulation tissue simultaneously. In this manuscript, we report a case and describe our experience with using this technique. PMID:26029557

Plastic or metal stents for benign extrahepatic biliary strictures: a systematic review

PubMed Central

2009-01-01

Background Benign biliary strictures may be a consequence of surgical procedures, chronic pancreatitis or iatrogenic injuries to the ampulla. Stents are increasingly being used for this indication, however it is not completely clear which stent type should be preferred. Methods A systematic review on stent placement for benign extrahepatic biliary strictures was performed after searching PubMed and EMBASE databases. Data were pooled and evaluated for technical success, clinical success and complications. Results In total, 47 studies (1116 patients) on outcome of stent placement were identified. No randomized controlled trials (RCTs), one non-randomized comparative studies and 46 case series were found. Technical success was 98,9% for uncovered self-expandable metal stents (uSEMS), 94,8% for single plastic stents and 94,0% for multiple plastic stents. Overall clinical success rate was highest for placement of multiple plastic stents (94,3%) followed by uSEMS (79,5%) and single plastic stents (59.6%). Complications occurred more frequently with uSEMS (39.5%) compared with single plastic stents (36.0%) and multiple plastic stents (20,3%). Conclusion Based on clinical success and risk of complications, placement of multiple plastic stents is currently the best choice. The evolving role of cSEMS placement as a more patient friendly and cost effective treatment for benign biliary strictures needs further elucidation. There is a need for RCTs comparing different stent types for this indication. PMID:20017920

Use of monorail PTCA balloon catheter for local drug delivery.

PubMed

Trehan, Vijay; Nair, Girish M; Gupta, Mohit D

2007-01-01

We report the use of monorail coronary balloon as an infusion catheter to give bailout abciximab selectively into the site of stent thrombosis as an adjunct to plain old balloon angioplasty (POBA) in a patient of subacute stent thrombosis of the left anterior descending coronary artery. The balloon component (polyamide material) of the monorail balloon catheter was shaved off the catheter so that abciximab injected through the balloon port of the catheter exited out the shaft of the balloon catheter at the site from where the balloon material was shaved off. We believe that selective infusion with abciximab along with POBA established antegrade flow and relieved the patient's ischemia. In the absence of essential hardware to give intracoronary drugs in an emergency situation, one may employ our technique of infusion through a monorail balloon catheter after shaving the balloon component from the catheter.

TOKYO criteria 2014 for transpapillary biliary stenting.

PubMed

Isayama, Hiroyuki; Hamada, Tsuyoshi; Yasuda, Ichiro; Itoi, Takao; Ryozawa, Shomei; Nakai, Yousuke; Kogure, Hirofumi; Koike, Kazuhiko

2015-01-01

It is difficult to carry out meta-analyses or to compare the results of different studies of biliary stents because there is no uniform evaluation method. Therefore, a standardized reporting system is required. We propose a new standardized system for reporting on biliary stents, the 'TOKYO criteria 2014', based on a consensus among Japanese pancreatobiliary endoscopists. Instead of stent occlusion, we use recurrent biliary obstruction, which includes occlusion and migration. The time to recurrent biliary obstruction was estimated using Kaplan-Meier analysis with the log-rank test. We can evaluate both plastic and self-expandable metallic stents (uncovered and covered). We also propose specification of the cause of recurrent biliary obstruction, identification of complications other than recurrent biliary obstruction, indication of severity, measures of technical and clinical success, and a standard for clinical care. Most importantly, the TOKYO criteria 2014 allow comparison of biliary stent quality across studies. Because blocked stents can be drained not only using transpapillary techniques but also by an endoscopic ultrasonography-guided transmural procedure, we should devise an evaluation method that includes transmural stenting in the near future. © 2014 The Authors. Digestive Endoscopy © 2014 Japan Gastroenterological Endoscopy Society.

Anatomic changes of target vessels after fenestrated and branched aortic aneurysm repair.

PubMed

Kalder, J; Keschenau, P; Tamm, M; Jalaie, H; Jacobs, M J; Greiner, A

2014-04-01

Objective of this study was to evaluate the anatomic changes of the stented target vessels after endovascular repair of complex aortic aneurysms. Between July 2011 and December 2013, 53 aortic aneurysms were treated in our department with fenestrated and branched stent-graft devices. Forty-two of these patients were pre- and postoperatively scanned with a high resolution computer tomography (CT) (Cook Zenith® fenestrated or branched, Australia Pty. Ltd., Brisbane, Australia: N.=19; AnacondaTM fenestrated, Vascutek, Glasgow, Scotland, UK: N.=23). The other 11 out of the 53 patients did not receive a CT scan, because of a pre-existing renal failure. In the CT scans we retrospectively evaluated the anatomic vessel deviation at the origin of the target vessel and the vessel shift distal to the stent. For the first measurement the CT scans were loaded into OsiriX MD®, and the pre- and postoperative angles of the target vessels were measured and subtracted. For matching, the CT-scans were normalized at vertebral body lumbar 2. The second measured angle was the maximal measured angle distal to the target vessel stent-graft. Altogether, 113 target vessels were stented (celiac trunk [CT] 15, superior mesenteric arteries [SMA] 26, renal arteries [RA] 72), with 97 balloon-expandable PTFE stents: 90 Atrium V12 (Maquet Getinge group, Hudson, NH, USA), 7 BeGrafts (Bentley InnoMed, Hechingen, Germany) and 16 self-expandable fluency PTFE stents (Bard, Karlsruhe, Germany). The mean anatomic deviation at the target vessel origin was 28±17.3 and the mean vessel shift distal to the stent was 36.3±18.8. There were no significant differences between the main device and the target vessel stent types. Fenestrated and branched stent-graft solutions for aortic aneurysm repair induce changes of the target vessel anatomy. We did not observe significant differences between the several devices.

Temporary placement of fully covered self-expandable metal stents in benign biliary strictures.

PubMed

Ryu, Choong Heon; Kim, Myung Hwan; Lee, Sang Soo; Park, Do Hyun; Seo, Dong Wan; Lee, Sung Koo

2013-07-01

Benign biliary strictures (BBSs) have been endoscopically managed with plastic stent placement. However, data regarding fully covered self-expandable metal stents (FCSEMSs) in BBS patients remain scarce in Korea. Forty-one patients (21 men, 65.9%) with BBSs underwent FCSEMS placement between February 2007 and July 2010 in Asan Medical Center. Efficacy and safety were evaluated retrospectively. Patients were considered to have resolution if they showed evidence of stricture resolution on cholangiography and if an inflated retrieval balloon easily passed through the strictures at FCSEMS removal. The mean FCSEMS placement time was 3.2 (1.9-6.2) months. Patients were followed for a mean of 10.2 (1.0-32.0) months after FCSEMS removal. The BBS resolution rate was confirmed in 38 of 41 (92.7%) patients who underwent FCSEMS removal. After FCSEMS removal, 6 of 38 (15.8%) patients experienced symptomatic recurrent stricture and repeat stenting was performed. When a breakdown by etiology of stricture was performed, 14 of 15 (93.3%) patients with chronic pancreatitis, 17 of 19 (89.5%) with gall stone-related disease, 4 of 4 (100%) with surgical procedures, and 2 of 2 (100%) with BBSs of other etiology had resolution at FCSEMS removal. Complications related to stent therapy occurred in 12 (29%) patients, including post-ERCP pancreatitis (n=4), proximal migration (n=3), distal migration (n=3), and occlusion (n=2). Temporary FCSEMS placement in BBS patients offers a potential alternative to plastic stenting. However, because of the significant complications and modest resolution rates, the potential benefits and risks should be evaluated in further investigations.

Primary stenting of subclavian and innominate artery occlusive disease: a single center's experience.

PubMed

Brountzos, E N; Petersen, B; Binkert, C; Panagiotou, I; Kaufman, J A

2004-01-01

To review immediate and midterm results of primary stenting for innominate and subclavian artery occlusive lesions. Retrospective data were collected from 48 consecutive symptomatic patients (27 men and 21 women, median age 64 years) having 49 subclavian and innominate artery lesions treated with stenting. Of the patients 52% had concomitant ischemic heart disease, and 30% had carotid and/or vertebral artery disease. Indication for treatment was vertebrobasilar insufficiency (VBI) in 16.6% of the patients; upper limb ischemia (ULI) in 31.3%; VBI and ULI in 12.5%; transient ischemic attack in 16.7%; angina in 12.5% before or after left internal mammary artery-to-coronary artery bypass grafting; and leg claudication in 10.4% before or after axillofemoral bypass grafting. Balloon-expandable stents were used in 44 lesions and self-expandable stents in 5 lesions. In total, 53 stents were placed in 48 patients. Technical success was 96%, and clinical success 94%. We encountered four complications (two puncture site hematomas, one distal hand embolization and one transient cerebral ischemia). Two patients died within 30 days from other causes, and seven patients were lost to follow-up. Mean follow-up time was 16.7 months (range 0.3 to 68.2). Five patients had recurrent lesions treated by surgical (n = 2) or endovascular (n = 3) means. Cumulative primary patency rate was 91.7% and 77% at 12 and 24 months, respectively. Cumulative secondary patency rate was 96.5% and 91.7% at 12 and 24 months, respectively. Stenting of subclavian and innominate artery lesions resulted in immediate resolution of patients' symptoms with durable midterm effect and few complications in a larger patient group with serious comorbid conditions.

Sirolimus- versus paclitaxel-eluting stents in patients with stenosis in a native coronary artery.

PubMed

Doggrell, Sheila A

2004-06-01

With stenting, restenosis occurs in approximately 25% of patients and the incidence is even higher in patients with diabetes, small coronary vessels and long lesions. The sirolimus-eluting balloon-expandable stent in the treatment of patients with de novo native coronary-artery lesions (SIRIUS) trial, enrolled patients with more challenging conditions, including a higher frequency of diabetes, more complex lesion morphology and longer lesions and showed benefits in all groups. After 240 days, the frequency of stenosis of at least 50% of the luminal diameter was 3.2 and 35.4% in the sirolimus and standard stents groups, respectively. The TAXUS-IV trial was the first large-scale trial on the safety and efficacy of paclitaxel-eluting stents in a broad population of patients and lesions, and established the safety and effectiveness of this agent. After 9 months, there was a mean stenosis of 17% in the paclitaxel group compared to 37% of patients treated with a bare stent. Thus, the local delivery of potent cell cycle inhibitors (sirolimus, paclitaxel) from stents being used for revascularisation dramatically decreases the incidence of restenosis in the populations of patients studied so far and represents a major advancement in the treatment of coronary artery disease.

Self-expandable metal stents for malignant gastric outlet obstruction: A pooled analysis of prospective literature.

PubMed

van Halsema, Emo E; Rauws, Erik A J; Fockens, Paul; van Hooft, Jeanin E

2015-11-21

To provide an overview of the clinical outcomes of self-expandable metal stent (SEMS) placement for malignant gastric outlet obstruction (MGOO). A systematic literature search was performed in PubMed of the literature published between January 2009 and March 2015. Only prospective studies that reported on the clinical success of stent placement for MGOO were included. The primary endpoint was clinical success, defined according to the definition used in the original article. Data were pooled and analyzed using descriptive statistics. Subgroup analyses were performed for partially covered SEMSs (PCSEMSs) and uncovered SEMSs (UCSEMSs) using Fisher's exact test. A total of 19 studies, including 1281 patients, were included in the final analysis. Gastric (42%) and pancreatic (37%) cancer were the main causes of MGOO. UCSEMSs were used in 76% of patients and PCSEMSs in 24%. The overall pooled technical success rate was 97.3% and the clinical success rate was 85.7%. Stent dysfunction occurred in 19.6% of patients, mainly caused by re-obstruction (12.6%) and stent migration (4.3%), and was comparable between PCSEMSs and UCSEMSs (21.2% vs 19.1%, respectively, P = 0.412). Re-obstruction was more common with UCSEMSs (14.9% vs 5.1%, P < 0.001) and stent migration was more frequent after PCSEMS placement (10.9% vs 2.2%, P < 0.001). The overall perforation rate was 1.2%. Bleeding was reported in 4.1% of patients, including major bleeding in 0.8%. The median stent patency ranged from 68 to 307 d in five studies. The median overall survival ranged from 49 to 183 d in 13 studies. The clinical outcomes in this large population showed that enteral stent placement was feasible, effective and safe. Therefore, stent placement is a valid treatment option for the palliation of MGOO.

Expandable right ventricular-to-pulmonary artery conduit: an animal study.

PubMed

Boudjemline, Younes; Laborde, François; Pineau, Emmanuelle; Mollet, Alix; Abadir, Sylvia; Borenstein, Nicolas; Behr, Luc; Bonhoeffer, Philipp

2006-06-01

This study was performed to assess a new vascular stent graft as an expandable valved conduit for right ventricular outflow tract (RVOT) reconstruction in sheep. Conduits were constructed by sewing an 18-mm valved conduit inside a stent. Crimped to 16 mm, they were implanted either under or without extracorporeal circulation in seven (group A) and in five (group B) sheep, respectively. Six weeks and 3 mo after their insertion, conduits were dilated intraluminally. A valved stent was implanted percutaneously into conduits before they were killed. Two animals from group A recovered normally, whereas five animals had a complicated postoperative course. In group B, one died acutely due to kinking of the conduit. Balloon dilatations were performed in all surviving animals. First dilatations had a slight impact on valvular function in all animals but one, whereas second dilatations led to significant PR in all. Transcatheter valve implantation was performed successfully. When animals were killed, no bleeding was found around the surgically implanted device. In conclusion, we designed a biologic valved conduit for RVOT reconstruction that can be dilated sequentially to follow animal growth. This new device can have tremendous applications in children with congenital heart diseases involving the RVOT.

Percutaneous Transluminal Cerebral Angioplasty and Stenting in Acute Vertebrobasilar Ischemic Stroke

PubMed Central

Nistri, M.; Mangiafico, S.; Cellerini, M.; Villa, G.; Mennonna, P.; Ammannati, F.; Giordano, G. P.

2002-01-01

Summary Reports of cerebral transluminal angioplasty and stenting in patients with vertebrobasilar ischemic stroke are scanty. Herein we report on the use of “monorail” coronary balloon angioplasty and stent balloon mounted catheters in two patients with acute vertebrobasilar ischemic stroke, focussing on the differences and possible advantages of the “monorail” technique in comparison with the “over-the-wire” technique. In both patients, the clinical picture was characterized by progressive brainstem symptoms followed by acute loss of consciousness related to an atherothrombotic occlusion and subocclusion of the dominant intracranial vertebral artery, respectively. In one patient, superselective thrombolytic therapy and balloon angioplasty resulted in a dissection flap at the vertebrobasilar junction. The latter was treated by successful deployment of a coronary stent. In the other patient, the subocclusive lesion was directly treated by angioplasty and stenting without thrombolytic therapy. The clinical outcome was poor for one patient (“locked in” syndrome) while the other had a complete clinical recovery. In acute atherothrombotic vertebrobasilar stroke transluminal cerebral angioplasty and stenting may be successfully performed allowing vessel recanalization. PMID:20594522

Optimization of stent implantation using a high pressure inflation protocol.

PubMed

Vallurupalli, Srikanth; Bahia, Amit; Ruiz-Rodriguez, Ernesto; Ahmed, Zubair; Hakeem, Abdul; Uretsky, Barry F

2016-01-01

High-pressure inflation is the universal standard for stent deployment but a specific protocol for its use is lacking. We developed a standardized "pressure optimization protocol" (POP) using time to inflation pressure stability as an endpoint for determining the required duration of stent inflation. The primary study purpose was to determine the stent inflation time (IT) in a large patient cohort using the standardized inflation protocol, to correlate various patient and lesion characteristics with IT, and ascertain in an in vitro study the time for pressure accommodation within an inflation system. Six hundred fifteen stent implants in 435 patients were studied. Multivariate analysis was performed to determine predictors of longer ITs. In an in vitro study, various stents and balloons were inflated in air to determine the pressure accommodation time of the inflation system. The mean stent IT was 104 ± 41 sec (range 30-380 sec). Stent length was the only predictor of prolonged stent inflation. The "accommodation time" in vitro of the stent inflation system itself was 33 ± 24 sec. The protocol was safe requiring premature inflation termination in <3% of stent implants. No serious adverse events occurred. Achieving stable inflation pressure requires on average over 100 sec and may require several minutes in individual cases. Stent length increases IT. These results suggest that the widespread practice of rapid inflation/deflation may not be sufficient to fully expand the stent and that the use of a pressure stability protocol will allow for safe, predictable, and more complete stent deployment. © 2015 Wiley Periodicals, Inc. © 2015 Wiley Periodicals, Inc.

Randomized Comparison of Paclitaxel-Eluting Balloon and Stenting Versus Plain Balloon Plus Stenting Versus Directional Atherectomy for Femoral Artery Disease (ISAR-STATH).

PubMed

Ott, Ilka; Cassese, Salvatore; Groha, Philipp; Steppich, Birgit; Hadamitzky, Martin; Ibrahim, Tareq; Kufner, Sebastian; Dewitz, Karl; Hiendlmayer, Regina; Laugwitz, Karl-Ludwig; Schunkert, Heribert; Kastrati, Adnan; Fusaro, Massimiliano

2017-06-06

Atherosclerosis in the superficial femoral artery is common in patients suffering from peripheral artery disease. Paclitaxel-eluting balloon (PEB) angioplasty, stenting, and directional atherectomy (DA) have provided new options for the treatment of superficial femoral artery disease; however, the comparative efficacy of these interventional strategies remains uncertain. One hundred and fifty-five patients with symptomatic peripheral artery disease due to de novo superficial femoral artery stenotic or occlusive lesions were randomized to treatment with plain balloon angioplasty (BA) followed by PEB angioplasty and stenting (n=48), BA and stenting (n=52), or DA with distal protection and bailout stenting (n=55). The primary end point of the study was percentage diameter stenosis after 6 months measured by angiography. Other end points included target lesion revascularization, thrombosis, ipsilateral amputation, binary restenosis, and all-cause mortality at 6 and 24 months. Baseline and lesion characteristics were comparable in all groups with a mean lesion length of 65.9±46.8 mm and 56% total occlusions. At 6 months angiography, the percent diameter stenosis was significantly lower in patients treated by PEB angioplasty and stenting (34±31%) as compared with BA angioplasty and stenting (56±29%, P =0.009) or DA (55±29%, P =0.007). Similarly, binary restenosis was significantly lower after treatment with PEB and stenting as compared with BA and stenting or DA. Clinical follow-up at 24 months revealed a lower risk for target lesion revascularization after PEB angioplasty and stenting as compared with BA and stenting or DA. We found no difference in terms of target lesion thrombosis and mortality among groups, and no patient underwent amputation. Treatment of de novo superficial femoral artery lesions with PEB angioplasty and stenting is superior to BA angioplasty and stenting or DA in terms of angiographic diameter stenosis at 6 months and target lesion revascularization at 24 months. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00986752. © 2017 American Heart Association, Inc.

The role of brachytherapy and Cutting Balloon angioplasty in the current treatment of stent restenosis.

PubMed

Bonan, Raoul

2004-09-01

The Gamma I, START and INHIBIT trials conclusively demonstrate the feasibility, safety and efficacy of intracoronary radiation as the treatment of choice for stent restenosis. Further reports confirm this finding and extend the indications. Vascular brachytherapy should be made available for all patients with diffuse stent restenosis. Specific devices such as cutting balloons may improve the procedure but does not seem to have an impact alone on the evolution.

Endoscopic minor papilla balloon dilation for the treatment of symptomatic pancreas divisum.

PubMed

Yamamoto, Natsuyo; Isayama, Hiroyuki; Sasahira, Naoki; Tsujino, Takeshi; Nakai, Yousuke; Miyabayashi, Koji; Mizuno, Suguru; Kogure, Hirofumi; Sasaki, Takashi; Hirano, Kenji; Tada, Minoru; Koike, Kazuhiko

2014-08-01

A subpopulation of patients with pancreas divisum experience symptomatic events such as recurrent acute pancreatitis and chronic pancreatitis. Minor papilla sphincterotomy has been reported as being an effective treatment. The aim of this study was to evaluate the safety and efficacy of endoscopic balloon dilation for the minor papilla. Between 2000 and 2012, 16 patients were retrospectively included in this study. After endoscopic balloon dilation for the minor papilla was received, a pancreatic stent or a nasal pancreatic drainage catheter was placed for 1 week. If a stricture or obstruction was evident, it was treated with balloon dilation followed by long-term stent placement (1 year). When an outflow of pancreatic juice was disturbed by a pancreatic stone, endoscopic stone extraction was performed. Balloon dilation and stent placement were achieved and were successful in all the cases (16/16; 100%). Clinical improvement was achieved in 7 (84.7%) of the 9 patients with recurrent acute pancreatitis and in 6 (85.7%) of the 7 patients with chronic pancreatitis. Early complications were observed in 1 (6.3%) patient. Pancreatitis or bleeding related to balloon dilation was not observed. Endoscopic balloon dilation for the minor papilla is feasible for the management of symptomatic pancreas divisum.

Deep intubation of 8 Fr guiding catheter to deliver coronary stent graft to seal coronary perforation: a case report.

PubMed

Salwan, R; Mathur, A; Jhamb, D K; Seth, A

2001-09-01

Coronary perforation is an uncommon complication of angioplasty and is a challenging situation to manage. We describe a case of complex multivessel coronary angioplasty complicated by coronary perforation following balloon rupture that was successfully managed with a coronary stent graft. Delivery of the stent graft to the site of vessel rupture required deep intubation of an 8 Fr guiding catheter over the shaft of an inflated balloon. In addition to the availability of covered stents, it is essential to be familiar with various skills necessary to deploy these stents. Cathet Cardiovasc Intervent 2001;54:59-62. Copyright 2001 Wiley-Liss, Inc.

Use of a wire extender during neuroprotected vertebral artery angioplasty and stenting.

PubMed

Lesley, Walter S; Kumar, Ravi; Rangaswamy, Rajesh

2010-09-01

The off-label use of an extender wire during vertebral artery stenting and angioplasty with or with neuroprotection has not been previously reported. Retrospective, single-patient, technical report. After monorail balloon angioplasty was performed on a proximal left vertebral artery stenosis, the 190 cm long Accunet neuroprotection filter device was not long enough for delivery of an over-the-wire stent. After mating a 145 cm long, 0.014 inch extension wire to the filter device, a balloon-mounted Liberté stent was implanted with good angiographic and clinical results. The off-label use of an extender wire permits successful over-the-wire stenting on a monorail neuroprotection device for vertebral artery endosurgery.

Computational fluid dynamics analysis of balloon-expandable coronary stents: influence of stent and vessel deformation.

PubMed

Martin, David M; Murphy, Eoin A; Boyle, Fergal J

2014-08-01

In many computational fluid dynamics (CFD) studies of stented vessel haemodynamics, the geometry of the stented vessel is described using non-deformed (NDF) geometrical models. These NDF models neglect complex physical features, such as stent and vessel deformation, which may have a major impact on the haemodynamic environment in stented coronary arteries. In this study, CFD analyses were carried out to simulate pulsatile flow conditions in both NDF and realistically-deformed (RDF) models of three stented coronary arteries. While the NDF models were completely idealised, the RDF models were obtained from nonlinear structural analyses and accounted for both stent and vessel deformation. Following the completion of the CFD analyses, major differences were observed in the time-averaged wall shear stress (TAWSS), time-averaged wall shear stress gradient (TAWSSG) and oscillatory shear index (OSI) distributions predicted on the luminal surface of the artery for the NDF and RDF models. Specifically, the inclusion of stent and vessel deformation in the CFD analyses resulted in a 32%, 30% and 31% increase in the area-weighted mean TAWSS, a 3%, 7% and 16% increase in the area-weighted mean TAWSSG and a 21%, 13% and 21% decrease in the area-weighted mean OSI for Stents A, B and C, respectively. These results suggest that stent and vessel deformation are likely to have a major impact on the haemodynamic environment in stented coronary arteries. In light of this observation, it is recommended that these features are considered in future CFD studies of stented vessel haemodynamics. Copyright © 2014 IPEM. Published by Elsevier Ltd. All rights reserved.

Experimental Study of Poly-l-Lactic Acid Biodegradable Stents in Normal Canine Bile Ducts

DOE Office of Scientific and Technical Information (OSTI.GOV)

Yamamoto, Kiyosei, E-mail: yamakiyo@zg7.so-net.ne.jp; Yoshioka, Tetsuya; Furuichi, Kinya

Purpose: This study was designed to clarify the advantages of biodegradable stents in terms of mucosal reaction and biodegradation after placement. We designed a biodegradable stent and assessed stent degradation and changes in the normal bile ducts of dogs. Methods: The biodegradable stent is a balloon-expandable Z stent consisting of poly-l-lactic acid (PLLA) with a diameter of 6 mm and a length of 15 mm. We assessed four groups of three beagle dogs each at 1, 3, 6, and 9 months of follow-up. After evaluating stent migration by radiography and stent and bile duct patency by cholangiography, the dogs weremore » sacrificed to remove the bile duct together with the stent. The bile duct lumen was examined macroscopically and histologically, and the stent degradation was examined macroscopically and by scanning electron microscopy (SEM). Results: Bile duct obstruction was absent and none of the stents migrated. Macroscopic evaluation showed moderate endothelial proliferation in the bile ducts at the implant sites at 3 and 6 months and a slight change at 9 months. Slight mononuclear cell infiltration was histologically identified at all time points and epithelial hyperplasia that was moderate at 3 months was reduced to slight at 6 and 9 months. Stent degradation was macroscopically evident in all animals at 9 months and was proven by SEM in two dogs at 6 months and in all of them at 9 months. Conclusions: Our results suggest that PLLA bioabsorbable stents seems to be useful for implantation in the biliary system with further investigation.« less

Fully covered self-expandable metal stent in tracheobronchial disorders: clinical experience.

PubMed

Marchese, Roberto; Poidomani, Grazia; Paglino, Giuseppe; Crimi, Claudia; Lo Nigro, Chiara; Argano, Vincenzo

2015-01-01

The third-generation fully covered self-expandable metallic stent (SEMS) has been developed to solve the problems of difficult removal and in-stent granuloma formation related to the uncovered or partially covered type. There are few written reports about the performance of this type of stents with early encouraging results. To report and analyse our experience with the Silmet® stent in the management of malignant and benign tracheobronchial disorders. We retrospectively reviewed medical records of patients who underwent fully covered SEMS Silmet placement at the Interventional Pulmonology Unit, La Maddalena Cancer Center, Palermo, Italy, between May 2010 and August 2013. Stents were placed in 52 patients with malignant (n = 49) and benign airway obstruction (n = 2) and broncho-oesophageal fistula (n = 1). SEMSs were inserted into the trachea (n = 19), the main bronchi (n = 21) and the peripheral bronchi (n = 31). Besides 1 procedural dislocation, the deployment was successful in all patients with an immediate significant improvement of symptoms (Barthel Index p < 0.001; Medical Research Council score p < 0.001). A radiographic improvement was detected in 48% of patients. The mean follow-up duration was 119 ± 120 days (range 22-549 days). Complications observed were: migration (7.6%), tumour overgrowth (15%), infections (5.7%), granulation tissue formation (3.8%) and mucus plug (3.8%). The Silmet stent is effective, safe and simple to implant and remove. We suggest its use in cases of tight stenoses, in the treatment of small- to medium-caliber airways or in cases of tortuous airways. © 2015 S. Karger AG, Basel.

Canine model of acute aortic rupture: treatment with percutaneous delivery of a covered Z stent--work in progress.

PubMed

Williams, D M; Andrews, J C; Chee, S S; Marx, M V; Abrams, G D

1994-01-01

To develop a percutaneous treatment for aortic rupture with use of a covered intraluminal stent. A transmural tear was created percutaneously in the thoracic aorta in six dogs with use of a 4-mm angioplasty balloon. Gianturco Z stents were covered with polytetrafluoroethylene, loaded into a 14-F sheath, and advanced through the femoral artery to the site of injury. Within 2 minutes after initiation of the injury, the stent was deployed. Homologous canine blood was given during the procedure. Dogs that survived 24 hours were then killed. The first stent did not expand completely, and the dog died in 1 hour. At necropsy, the first two dogs (1-hour and 8-hour survival) had a large left hemothorax and extensive periaortic hematoma, indicating intrathoracic exsanguination. The next four dogs were treated with a modified stent and survived 2 hours (n = 1), 8 hours (n = 1), and 24 hours (n = 2). At necropsy hemothorax did not exceed 15 mL, and periaortic hematomas were small. The cause of death in the two early casualties with the modified stent is uncertain. There were no signs of spinal cord injury despite occlusion of three pairs of intercostal arteries. The covered Z stent (in its modified form) tamponaded the aortic tear, preventing exsanguination. Long-term studies of biocompatibility of this device appear justified.

Endovascular Repair of Acute Symptomatic Pararenal Aortic Aneurysm With Three Chimney and One Periscope Graft for Complete Visceral Artery Revascularization

DOE Office of Scientific and Technical Information (OSTI.GOV)

Brechtel, Klaus, E-mail: klaus.brechtel@med.uni-tuebingen.de; Ketelsen, Dominik; Endisch, Andrea

2012-04-15

PurposeTo describe a modified endovascular technique for complete revascularization of visceral and renal arteries in symptomatic pararenal aortic aneurysm (PRAA).TechniqueArterial access was surgically established in both common femoral arteries (CFAs) and the left subclavian artery (LSA). Revascularization of the left renal artery, the celiac trunk, and the superior mesenteric artery was performed through one single sheath via the LSA. Suitable covered stents were put in the aortic branches but not deployed. The right renal artery was accessed over the left CFA. Due to the longitudinal extension of the presented aneurysm two stent-grafts were introduced via the right CFA. After deployingmore » the aortic stent-grafts, all covered stents in the side branches were deployed consecutively with a minimum overlap of 5 mm over the cranial and caudal stent-graft edges. Simultaneous ballooning was performed to fully expand all stent-grafts and warranty patency. Conclusion: This is the first report in the literature of chimney grafting in PRAA for complete revascularization of visceral and renal branches by using more than two covered stents introduced from one side through one single sheath. However this technique is modified, it should be used only in bailout situations when branched stent-grafts are not available and/or surgery is not suitable.« less

A rare complication: Undeflatable balloon of the stent

PubMed Central

Şatiroğlu, Ömer; Erdoğan, Turan; Durakoğlugil, Murtaza Emre; Uğurlu, Yavuz

2013-01-01

Percutaneous coronary intervention is an important modality in the treatment of coronary artery disease. These procedures are usually completed successfully, but occasionally serious complications are encountered. In this paper, we present the case of an undeflatable stent balloon, which is an extremely rare complication that has not been described in the literature. PMID:24265889

Successful Use of Orbital Atherectomy as an Adjunct in Treating Extensively Calcified Mesenteric Artery Lesions.

PubMed

Richard, Michele; Krol, Emilia; Dietzek, Alan

2016-10-01

To describe the use of orbital technique of atherectomy as an adjunct to successful angioplasty and stent placement of the superior mesenteric artery (SMA). The technique is demonstrated in a 68-year-old man with critical SMA stenosis. The SMA was cannulated with 0.014-in wire, but the lesion was highly stenotic and densely calcified and prevented the passage of even the smallest 1.5-mm balloon. Orbital atherectomy was thus performed with a 1.25-mm CSI crown. Balloon angioplasty was then possible with a 4 mm × 2 cm balloon followed by placement of a 7 mm × 22 mm balloon-mounted stent. The use of atherectomy as an adjunct to angioplasty and stenting in extensive, calcified SMA lesions supports the value of this technique to avoid a much larger and morbid open procedure. Published by Elsevier Inc.

Carotid artery stenting: current and emerging options

PubMed Central

Morr, Simon; Lin, Ning; Siddiqui, Adnan H

2014-01-01

Carotid artery stenting technologies are rapidly evolving. Options for endovascular surgeons and interventionists who treat occlusive carotid disease continue to expand. We here present an update and overview of carotid stenting devices. Evidence supporting carotid stenting includes randomized controlled trials that compare endovascular stenting to open surgical endarterectomy. Carotid technologies addressed include the carotid stents themselves as well as adjunct neuroprotective devices. Aspects of stent technology include bare-metal versus covered stents, stent tapering, and free-cell area. Drug-eluting and cutting balloon indications are described. Embolization protection options and new direct carotid access strategies are reviewed. Adjunct technologies, such as intravascular ultrasound imaging and risk stratification algorithms, are discussed. Bare-metal and covered stents provide unique advantages and disadvantages. Stent tapering may allow for a more fitted contour to the caliber decrement between the common carotid and internal carotid arteries but also introduces new technical challenges. Studies regarding free-cell area are conflicting with respect to benefits and associated risk; clinical relevance of associated adverse effects associated with either type is unclear. Embolization protection strategies include distal filter protection and flow reversal. Though flow reversal was initially met with some skepticism, it has gained wider acceptance and may provide the advantage of not crossing the carotid lesion before protection is established. New direct carotid access techniques address difficult anatomy and incorporate sophisticated flow-reversal embolization protection techniques. Carotid stenting is a new and exciting field with rapidly advancing technologies. Embolization protection, low-risk deployment, and lesion assessment and stratification are active areas of research. Ample room remains for further innovations and developments. PMID:25349483

Effects of plaque lengths on stent surface roughness.

PubMed

Syaifudin, Achmad; Takeda, Ryo; Sasaki, Katsuhiko

2015-01-01

The physical properties of the stent surface influence the effectiveness of vascular disease treatment after stent deployment. During the expanding process, the stent acquires high-level deformation that could alter either its microstructure or the magnitude of surface roughness. This paper constructed a finite element simulation to observe the changes in surface roughness during the stenting process. Structural transient dynamic analysis was performed using ANSYS, to identify the deformation after the stent is placed in a blood vessel. Two types of bare metal stents are studied: a Palmaz type and a Sinusoidal type. The relationship between plaque length and the changes in surface roughness was investigated by utilizing three different length of plaque; plaque length longer than the stent, shorter than the stent and the same length as the stent. In order to reduce computational time, 3D cyclical and translational symmetry was implemented into the FE model. The material models used was defined as a multilinear isotropic for stent and hyperelastic for the balloon, plaque and vessel wall. The correlation between the plastic deformation and the changes in surface roughness was obtained by intermittent pure tensile test using specimen whose chemical composition was similar to that of actual stent material. As the plastic strain is achieved from FE simulation, the surface roughness can be assessed thoroughly. The study found that the plaque size relative to stent length significantly influenced the critical changes in surface roughness. It was found that the length of stent which is equal to the plaque length was preferable due to the fact that it generated only moderate change in surface roughness. This effect was less influential to the Sinusoidal stent.

Stenting for symptomatic intracranial vertebrobasilar artery stenosis: 30-day results in a high-volume stroke center.

PubMed

Liu, Lian; Zhao, Xiaojing; Mo, Dapeng; Ma, Ning; Gao, Feng; Miao, Zhongrong

2016-04-01

Symptomatic intracranial vertebrobasilar artery stenosis (IVBS) carries a high annual risk of recurrent stroke. Endovascular therapy was a promising technique but recent trials suggest it may carry a risk of periprocedual complications especially in inexperienced hands. This prospective study was to evaluate the safety of endovascular therapy for severe symptomatic IVBS in a high volume stroke centre. Patients with symptomatic IVBS caused by 70-99% stenosis despite medical treatment of at least one antiplatelet agent and statin were enrolled. The patients were treated either with balloon-mounted stent or balloon pre-dilation plus self-expanding stent as determined by the operators following a guideline. The primary outcome was 30-day stroke, transient ischemic attack (TIA) and death after stenting. The secondary outcome was successful stent deployment. The baseline characteristics and outcomes of patients with basilar artery (BA) lesions and patients with vertebral artery V4 segment lesions (BA group vs V4 group) were compared. And the outcome of different Mori type lesions was also compared. From September 2013 to September 2014, 105 patients with stroke or TIA due to intracranial IVBS were screened and 97 patients were treated by stenting, including 52 patients with BA stenosis and 45 patients with V4 stenosis. The rate of 30-day stroke, TIA and death was 7.1%. All the three strokes happened in the BA group and were perforator strokes. The successful stent deployment rate was 100%. General anesthesia was more preferred in the BA group than in the V4 groups (96.2% vs 75.6%, p=0.005). The Apollo stent was used more for Mori A lesions (30.5% vs 7.9%, p=0.011) and had lower degree of residual stenosis (8.6% vs 12.6%, p=0.014) than Wingspan stent. Mori C lesions were more likely to have higher degree of residual stenosis than Mori A lesion (15.3% vs 7.4%, p=0.005). The short-term safety of endovascular stenting for patients with severe symptomatic IVBS in a high volume stroke centre was acceptable. Mori A lesions may have lower residual stenosis rate than the Mori C type lesions. Copyright © 2016. Published by Elsevier B.V.

Stent-assisted, balloon-induced intimal disruption and relamination of aortic dissection in patients with Marfan syndrome: Midterm outcomes and aortic remodeling.

PubMed

Faure, Elsa Madeleine; El Batti, Salma; Abou Rjeili, Marwan; Ben Abdallah, Iannis; Julia, Pierre; Alsac, Jean-Marc

2018-05-17

The study objective was to assess the midterm outcomes and aortic remodeling in patients with Marfan syndrome with complicated acute type B aortic dissection treated with stent-assisted, balloon-induced intimal disruption and relamination. We reviewed all patients treated with stent-assisted, balloon-induced intimal disruption and relamination for a complicated acute type B aortic dissection associated with Marfan syndrome according to the revised Ghent criteria. Between 2015 and November 2017, 7 patients with Marfan syndrome underwent stent-assisted, balloon-induced intimal disruption and relamination for a complicated acute type B aortic dissection. The median age of patients was 47 years (range, 23-70). Four patients had a history of aortic root replacement. Technical success was achieved in 100%. Three patients required an adjunctive procedure for renal artery stenting (n = 2) and iliac artery stenting (n = 1). There was no in-hospital death, 30-day postoperative stroke, spinal cord ischemia, ischemic colitis, or renal failure requiring dialysis. At a median follow-up of 15 months (range, 7-28), 1 patient required aortic arch replacement for aneurysmal degeneration associated with a type Ia endoleak at 2 years, giving a late reintervention rate of 14%. There was no other secondary endoleak. The primary visceral patency rate was 100%. There were no all-cause deaths reported. At last computed tomography scan, all patients had complete aortic remodeling of the treated thoracoabdominal aorta. Distally, at the nonstented infrarenal aortoiliac level, 6 patients had persistent false lumen flow with stable aorto-iliac diameter in 5. One patient had iliac diameter growth (27 mm diameter at last computed tomography scan). Stent-assisted, balloon-induced intimal disruption and relamination of aortic dissection in patients with Marfan syndrome is feasible, safe, and associated with an immediate and midterm persisting thoracoabdominal aortic remodeling. Copyright © 2018 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

Exclusion of Atherosclerotic Plaque from the Circulation Using Stent-Grafts: Alternative to Carotid Stenting with a Protection Device?

DOE Office of Scientific and Technical Information (OSTI.GOV)

Peynircioglu, Bora, E-mail: borapeynir@gmail.com; Geyik, Serdar; Yavuz, Kivilcim

2007-09-15

Purpose. To retrospectively assess the feasibility, safety, and clinical mid-term outcome of patients undergoing carotid artery stenting with stent-grafts. Methods. Over a 4 year period stent-grafts were used in the endovascular treatment of symptomatic internal carotid artery stenosis in 12 patients (2 women, 10 men, aged 47-83 (mean 64) years). Protection devices were not used. Possible microembolic complications were evaluated by magnetic resonance imaging (MRI) examinations of the brain before and the day after the procedure in all patients. Mean follow-up was 22 months (range 1-42 months), by Doppler ultrasonography and conventional angiography as well as clinical examination .Results. Themore » technical success rate was 100%. A total of 13 coronary stent-grafts were used. The mean stenosis rate (in terms of diameter) was 85% and the mean length of stent-grafts used was 20.9 mm. The mean diameter to which the stent-grafts were dilated was 4.66 mm. In-hospital complications occurred in 1 patient who suffered a minor femoral access hematoma that did not require transfusion or surgical decompression. Post-stenting diffusion-weighted MRI revealed several ipsilateral silent microemboli in only 1 case, which was completely asymptomatic. Two patients had a major stroke after 2 years of follow-up. Restenosis was found in 2 patients who underwent successful balloon dilatation followed by placement of a self-expandable bare stent within the stent-grafts. Conclusions. Stent-grafts may prevent microembolic complications during stenting of atherosclerotic carotid lesions in selected cases, offering immediate exclusion of the atherosclerotic lesion from the circulation by pressing the plaque against the vessel wall. Comparative, randomized studies in larger series of patients are needed with carotid-dedicated stent-graft designs.« less

To kiss or not to kiss? Impact of final kissing-balloon inflation on early and long-term results of percutaneous coronary intervention for bifurcation lesions.

PubMed

Biondi-Zoccai, Giuseppe; Sheiban, Imad; De Servi, Stefano; Tamburino, Corrado; Sangiorgi, Giuseppe; Romagnoli, Enrico

2014-11-01

Final kissing-balloon inflation is often recommended for percutaneous coronary intervention (PCI) of bifurcation lesions. However, randomized trials focusing on kissing inflation have not confirmed its beneficial impact. We compared outcomes of kissing inflation for PCI of bifurcation lesions, explicitly stratifying results according to stenting strategy. Patients undergoing bifurcation PCI were retrospectively enrolled. Subjects receiving final kissing inflation were compared with those not undergoing kissing inflation, after stratification for a single-stent technique. The primary end point was the long-term rate of major adverse cardiac events (MACE, i.e., death, myocardial infarction, or target lesion revascularization (TLR)). A total of 4314 patients were included: 1176 (27.3 %) treated with a single stent and kissing inflation, 1637 (37.9 %) with a single stent but no kissing, 1072 (24.8 %) with two stents and kissing, and 429 (9.9 %) with two stents but no kissing. At unadjusted analyses kissing was associated with fewer short-term MACE and deaths in the two-stent group, and with fewer long-term MACE, cardiac deaths, and side-branch TLR in the two-stent group (all P < 0.05). Conversely, kissing appeared detrimental after single stenting. However, after multivariable analyses, kissing no longer significantly affected the risk of adverse events, with the exception of the risk of side-branch TLR, which was lower in those receiving two stents and final kissing inflation (hazard ratio = 0.52, 95 % confidence interval 0.30–0.90, P = 0.020). Kissing inflation can be avoided in bifurcation lesions uneventfully treated with single-stent PCI. However, final kissing-balloon inflation appears beneficial in reducing the risk of side-branch repeat revascularization after using a two-stent strategy.

Fatigue and In Vivo Validation of a Peritoneum-Lined Self-Expanding Nitinol Stent-Graft

PubMed Central

Bastijanic, Jennifer M.; Etscheidt, Jordan; Sattiraju, Mallika; Bonsignore, Craig; Kopchok, George; White, Rodney; Sarac, Timur P.

2014-01-01

Purpose To assess the fatigue and in vivo performance of a new stent-graft incorporating bovine peritoneum lining that is designed for application in peripheral vascular occlusive disease. Methods Bovine peritoneum-lined stent-grafts were subjected to accelerated in vitro pulsatile fatigue and axial/torsional fatigue testing designed to simulate 10 years of physiological strain on the devices. At specified times the devices were evaluated for stent fracture, suture failure, or tissue tearing. Seven dogs underwent bilateral common iliac artery (CIA) balloon angioplasty injury with unilateral placement of the peritoneum-lined stent-graft. Angiography and intravascular ultrasound were performed prior to treatment, after treatment, and prior to sacrifice at 30 days. Vessels were perfusion fixed and histologically evaluated at 5 regions: above stent, proximal stent, mid stent, distal stent, and below stent. Results No evidence of stent, suture, or tissue failure was present during or after pulsatile and axial/torsional fatigue testing. At 30±0.3 days after implantation, all vessels were patent. The average lumen area at explantation across stented vessels was 25.45 mm2. Lumen areas tended to be reduced above (23.57 mm2) and below (24.17 mm2) the stent. Lumen areas were consistent across stented regions at explantation (proximal stent 27.80 mm2, mid stent 25.88 mm2, and distal stent 25.81 mm2). The mean neointimal area in peritoneum-lined stents was 2.02±1.52 mm2, with a neointima:media ratio of 1.03±0.50. These values were significantly lower in the above and below stent areas than in the stented regions, but there was no difference in either measure within the proximal, mid, or distal stent. Conclusion The custom-designed peritoneum-lined stent-graft is promising for clinical peripheral applications due to its ability to resist relevant long-term physiological stresses and outstanding short-term patency rates in canine implantations. PMID:25290804

Angioplasty and stent - heart - discharge

MedlinePlus

Drug-eluting stents - discharge; PCI - discharge; Percutaneous coronary intervention - discharge; Balloon angioplasty - discharge; Coronary angioplasty - discharge; Coronary artery angioplasty - discharge; Cardiac ...

TAVR and SAVR: Current Treatment of Aortic Stenosis.

PubMed

Hu, Patrick P

2012-01-01

Transcatheter aortic valve replacement (TAVR) was approved in the United States in late 2011, providing a critically needed alternative therapy for patients with severe aortic stenosis previously refused surgical aortic valve replacement (SAVR). Over 20,000 TAVR have been performed in patients worldwide since 2002 when Alain Cribier performed the first-in-man TAVR. This paper reviews the data from balloon expandable and self-expanding aortic stent valves as well as data comparing them with traditional surgical aortic valve replacement (SAVR). Complications using criteria established by the Valve Academic Research Consortium (VARC) are reviewed. Future challenges and possibilities are discussed and will make optimizing TAVR an important goal in the years to come.

TAVR and SAVR: Current Treatment of Aortic Stenosis

PubMed Central

Hu, Patrick P.

2012-01-01

Transcatheter aortic valve replacement (TAVR) was approved in the United States in late 2011, providing a critically needed alternative therapy for patients with severe aortic stenosis previously refused surgical aortic valve replacement (SAVR). Over 20,000 TAVR have been performed in patients worldwide since 2002 when Alain Cribier performed the first-in-man TAVR. This paper reviews the data from balloon expandable and self-expanding aortic stent valves as well as data comparing them with traditional surgical aortic valve replacement (SAVR). Complications using criteria established by the Valve Academic Research Consortium (VARC) are reviewed. Future challenges and possibilities are discussed and will make optimizing TAVR an important goal in the years to come. PMID:22952419

Wire stent for tracheomalacia in a five-year-old girl.

PubMed

Bousamra, M; Tweddell, J S; Wells, R G; Splaingard, M L; Sty, J R

1996-04-01

A wire stent was used successfully to treat life-threatening tracheomalacia in a 5-year-old girl. Wire stents placed bronchoscopically are nonobstructing and have the potential for balloon expansion to accommodate growth.

3-Year Clinical Follow-Up of the RIBS IV Clinical Trial: A Prospective Randomized Study of Drug-Eluting Balloons Versus Everolimus-Eluting Stents in Patients With In-Stent Restenosis in Coronary Arteries Previously Treated With Drug-Eluting Stents.

PubMed

Alfonso, Fernando; Pérez-Vizcayno, María José; Cuesta, Javier; García Del Blanco, Bruno; García-Touchard, Arturo; López-Mínguez, José Ramón; Masotti, Mónica; Zueco, Javier; Cequier, Angel; Velázquez, Maite; Moreno, Raúl; Mainar, Vicente; Domínguez, Antonio; Moris, Cesar; Molina, Eduardo; Rivero, Fernando; Jiménez-Quevedo, Pilar; Gonzalo, Nieves; Fernández-Pérez, Cristina

2018-05-28

This study sought to compare the long-term safety and efficacy of drug-eluting balloons (DEB) and everolimus-eluting stents (EES) in patients with in-stent restenosis (ISR) of drug-eluting stents (DES). Treatment of patients with DES-ISR remains a challenge. The RIBS IV (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloons vs Everolimus-Eluting Stents) trial is a prospective multicenter randomized clinical trial comparing DEB and EES in patients with DES-ISR. The pre-specified comparison of the 3-year clinical outcomes obtained with these interventions is the main objective of the present study. A total of 309 patients with DES-ISR were randomized to DEB (n = 154) or EES (n = 155). At angiographic follow-up, the in-segment minimal lumen diameter was larger in the EES arm (2.03 ± 0.7 mm vs. 1.80 ± 0.6 mm; p < 0.01). Three-year clinical follow-up was obtained in all enrolled patients (100%). The combined clinical outcome measure of cardiac death, myocardial infarction and target lesion revascularization was significantly reduced in the EES arm (19 [12.3%] vs. 31 [20.1%]; p = 0.04; hazard ratio: 0.57 [95% confidence interval: 0.34 to 0.96]), driven by a lower need for target lesion revascularization (11 [7.1%] vs. 24 [15.6%]; p = 0.015; hazard ratio: 0.43 [95% confidence interval: 0.21 to 0.87]). The need for "late" (>1 year) target lesion revascularization (2.6% vs. 4%) and target vessel revascularization (4% vs. 6.6%) was similar in the 2 arms. Rates of cardiac death (3.9% vs. 3.2%), myocardial infarction (2.6% vs. 4.5%), and stent thrombosis (1.3% vs. 2.6%) at 3 years were also similar in both arms. The 3-year clinical follow-up of this randomized clinical trial demonstrates that in patients with DES-ISR, EES reduce the need for repeat interventions compared with DEB. (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloons vs Everolimus-Eluting Stents [RIBS IV]; NCT01239940). Published by Elsevier Inc.

Biodegradable Magnesium Stent Treatment of Saccular Aneurysms in a Rat Model - Introduction of the Surgical Technique.

PubMed

Nevzati, Edin; Rey, Jeannine; Coluccia, Daniel; D'Alonzo, Donato; Grüter, Basil; Remonda, Luca; Fandino, Javier; Marbacher, Serge

2017-10-01

The steady progess in the armamentarium of techniques available for endovascular treatment of intracranial aneurysms requires affordable and reproducable experimental animal models to test novel embolization materials such as stents and flow diverters. The aim of the present project was to design a safe, fast, and standardized surgical technique for stent assisted embolization of saccular aneurysms in a rat animal model. Saccular aneurysms were created from an arterial graft from the descending aorta.The aneurysms were microsurgically transplanted through end-to-side anastomosis to the infrarenal abdominal aorta of a syngenic male Wistar rat weighing >500 g. Following aneurysm anastomosis, aneurysm embolization was performed using balloon expandable magnesium stents (2.5 mm x 6 mm). The stent system was retrograde introduced from the lower abdominal aorta using a modified Seldinger technique. Following a pilot series of 6 animals, a total of 67 rats were operated according to established standard operating procedures. Mean surgery time, mean anastomosis time, and mean suturing time of the artery puncture site were 167 ± 22 min, 26 ± 6 min and 11 ± 5 min, respectively. The mortality rate was 6% (n=4). The morbidity rate was 7.5% (n=5), and in-stent thrombosis was found in 4 cases (n=2 early, n=2 late in stent thrombosis). The results demonstrate the feasibility of standardized stent occlusion of saccular sidewall aneurysms in rats - with low rates of morbidity and mortality. This stent embolization procedure combines the opportunity to study novel concepts of stent or flow diverter based devices as well as the molecular aspects of healing.

Angioplasty and stent placement - heart

MedlinePlus

PCI; Percutaneous coronary intervention; Balloon angioplasty; Coronary angioplasty; Coronary artery angioplasty; Percutaneous transluminal coronary angioplasty; Heart artery dilatation; Angina - stent placement; Acute coronary ...

Drug eluting balloons for de novo coronary lesions – a systematic review and meta-analysis

PubMed Central

2013-01-01

Background The role of drug-eluting balloons (DEB) is unclear. Increasing evidence has shown a benefit for the treatment of in-stent restenosis. Its effect on de novo coronary lesions is more controversial. Several smaller randomized trials found conflicting results. Methods This is a systematic review and meta-analysis of randomized controlled trials (RCT) evaluating the effect of local Paclitaxel delivery/drug eluting balloons (DEB) (+/− bare metal stent) compared to current standard therapy (stenting) to treat de novo coronary lesions. Data sources for RCT were identified through a literature search from 2005 through 28 December 2012. The main endpoints of interest were target lesion revascularization (TLR), major adverse cardiac events (MACE), binary in-segment restenosis, stent thrombosis (ST), myocardial infarction (MI), late lumen loss (LLL) and mortality. A random effects model was used to calculate the pooled relative risks (RR) with 95% confidence intervals. Results Eight studies (11 subgroups) and a total of 1,706 patients were included in this analysis. Follow-up duration ranged from 6 to 12 months. Overall, DEB showed similar results to the comparator treatment. The relative risk (RR) for MACE was 0.95 (0.64 to 1.39); P = 0.776, for mortality it was 0.79 (0.30 to 2.11), P = 0.644, for stent thrombosis it was 1.45 (0.42 to 5.01), P = 0.560, for MI it was 1.26 (0.49 to 3.21), P = 0.629, for TLR it was 1.09 (0.71 to 1.68); P = 0.700 and for binary in-stent restenosis it was 0.96 (0.48 to 1.93), P = 0.918. Compared to bare metal stents (BMS), DEB showed a lower LLL (− 0.26 mm (−0.51 to 0.01)) and a trend towards a lower MACE risk (RR 0.66 (0.43 to 1.02)). Conclusion Overall, drug-eluting balloons (+/− bare metal stent) are not superior to current standard therapies (BMS or drug eluting stent (DES)) in treating de novo coronary lesions. However, the performance of DEB seems to lie in between DES and BMS with a trend towards superiority over BMS alone. Therefore, DEB may be considered in patients with contraindications for DES. The heterogeneity between the included studies is a limitation of this meta-analysis; different drug-eluting balloons have been used. PMID:23657123

Radiologic Placement of Uncovered Stents for the Treatment of Malignant Colonic Obstruction Proximal to the Descending Colon

DOE Office of Scientific and Technical Information (OSTI.GOV)

Yoon, Jehong; Kwon, Se Hwan, E-mail: Kwon98@khu.ac.kr; Lee, Chang-Kyun

PurposeTo evaluate the safety, feasibility, and patency rates of radiologic placement of uncovered stents for the treatment of malignant colonic obstruction proximal to the descending colon.Materials and MethodsThis was a retrospective, single-center study. From May 2003 to March 2015, 53 image-guided placements of uncovered stents (44 initial placements, 9 secondary placements) were attempted in 44 patients (male:female = 23:21; mean age, 71.8 years). The technical and clinical success, complication rates, and patency rates of the stents were also evaluated. Technical success was defined as the successful deployment of the stent under fluoroscopic guidance alone and clinical success was defined as the relief of obstructivemore » symptoms or signs within 48 h of stent deployment.ResultsIn total, 12 (27.3 %) patients underwent preoperative decompression, while 32 (72.7 %) underwent decompression with palliative intent. The technical success rate was 93.2 % (41/44) for initial placement and 88.9 % (8/9) for secondary placement. Secondary stent placement in the palliative group was required in nine patients after successful initial stent placement due to stent obstruction from tumor ingrowth (n = 7) and stent migration (n = 2). The symptoms of obstruction were relieved in all successful cases (100 %). In the palliative group, the patency rates were 94.4 % at 1 month, 84.0 % at 3 months, 64.8 % at 6 months, and 48.6 % at 12 months.ConclusionsThe radiologic placement of uncovered stents for the treatment of malignant obstruction proximal to the descending colon is feasible and safe, and provides acceptable clinical results.« less

Impact of different aortic valve calcification patterns on the outcome of transcatheter aortic valve implantation: A finite element study.

PubMed

Sturla, Francesco; Ronzoni, Mattia; Vitali, Mattia; Dimasi, Annalisa; Vismara, Riccardo; Preston-Maher, Georgia; Burriesci, Gaetano; Votta, Emiliano; Redaelli, Alberto

2016-08-16

Transcatheter aortic valve implantation (TAVI) can treat symptomatic patients with calcific aortic stenosis. However, the severity and distribution of the calcification of valve leaflets can impair the TAVI efficacy. Here we tackle this issue from a biomechanical standpoint, by finite element simulation of a widely adopted balloon-expandable TAVI in three models representing the aortic root with different scenarios of calcific aortic stenosis. We developed a modeling approach realistically accounting for aortic root pressurization and complex anatomy, detailed calcification patterns, and for the actual stent deployment through balloon-expansion. Numerical results highlighted the dependency on the specific calcification pattern of the "dog-boning" of the stent. Also, local stent distortions were associated with leaflet calcifications, and led to localized gaps between the TAVI stent and the aortic tissues, with potential implications in terms of paravalvular leakage. High stresses were found on calcium deposits, which may be a risk factor for stroke; their magnitude and the extent of the affected regions substantially increased for the case of an "arc-shaped" calcification, running from commissure to commissure. Moreover, high stresses due to the interaction between the aortic wall and the leaflet calcifications were computed in the annular region, suggesting an increased risk for annular damage. Our analyses suggest a relation between the alteration of the stresses in the native anatomical components and prosthetic implant with the presence and distribution of relevant calcifications. This alteration is dependent on the patient-specific features of the calcific aortic stenosis and may be a relevant indicator of suboptimal TAVI results. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

The NICE recommendation for drug-coated balloons and its global impact.

PubMed

Eccleshall, Simon; Waliszewski, M

2015-06-01

The clinical efficacy and safety of drug-coated balloon (DCB) angioplasty in patients with coronary in-stent restenosis (ISR) has been demonstrated. The objective of this article is to provide comparative cost efficacy data for DCB angioplasty in various countries based on the original methodology of the Medical Technologies Evaluation Programme (MTEP) at the National Institute for Health and Clinical Excellence (NICE) in 2010. Published and unpublished Health Technology Assessment (HTA) reports were evaluated for comparison in selected countries. Furthermore, a systematic review of economic evaluations of DCB angioplasty versus standard treatments (uncoated balloon angioplasty or drug-eluting stent implantations) was conducted. National cost efficacy data were evaluated using Markov state transition models which were adapted to fit each country's device and procedure related costs. The clinical input for adverse events was defined with two relevant trials for in-stent restenosis of bare metal stents (BMS-ISR) and of drug-eluting stents (DES-ISR). In the UK, Germany, Switzerland, South Africa, Japan and Brazil, DCB angioplasty is cost-effective when compared with drug-eluting stents to treat either BMS-ISR or DES-ISR. DCB angioplasty ought to be the preferred treatment option for patients with BMS-ISR and DES-ISR from the payers' point of view. © The Author(s), 2015.

Self-expandable metal stents for malignant gastric outlet obstruction: A pooled analysis of prospective literature

PubMed Central

van Halsema, Emo E; Rauws, Erik AJ; Fockens, Paul; van Hooft, Jeanin E

2015-01-01

AIM: To provide an overview of the clinical outcomes of self-expandable metal stent (SEMS) placement for malignant gastric outlet obstruction (MGOO). METHODS: A systematic literature search was performed in PubMed of the literature published between January 2009 and March 2015. Only prospective studies that reported on the clinical success of stent placement for MGOO were included. The primary endpoint was clinical success, defined according to the definition used in the original article. Data were pooled and analyzed using descriptive statistics. Subgroup analyses were performed for partially covered SEMSs (PCSEMSs) and uncovered SEMSs (UCSEMSs) using Fisher’s exact test. RESULTS: A total of 19 studies, including 1281 patients, were included in the final analysis. Gastric (42%) and pancreatic (37%) cancer were the main causes of MGOO. UCSEMSs were used in 76% of patients and PCSEMSs in 24%. The overall pooled technical success rate was 97.3% and the clinical success rate was 85.7%. Stent dysfunction occurred in 19.6% of patients, mainly caused by re-obstruction (12.6%) and stent migration (4.3%), and was comparable between PCSEMSs and UCSEMSs (21.2% vs 19.1%, respectively, P = 0.412). Re-obstruction was more common with UCSEMSs (14.9% vs 5.1%, P < 0.001) and stent migration was more frequent after PCSEMS placement (10.9% vs 2.2%, P < 0.001). The overall perforation rate was 1.2%. Bleeding was reported in 4.1% of patients, including major bleeding in 0.8%. The median stent patency ranged from 68 to 307 d in five studies. The median overall survival ranged from 49 to 183 d in 13 studies. CONCLUSION: The clinical outcomes in this large population showed that enteral stent placement was feasible, effective and safe. Therefore, stent placement is a valid treatment option for the palliation of MGOO. PMID:26604654

Aggressive plaque modification with rotational atherectomy and cutting balloon for optimal stent expansion in calcified lesions

PubMed Central

Tang, Zhe; Bai, Jing; Su, Shao-Ping; Lee, Pui-Wai; Peng, Liang; Zhang, Tao; Sun, Ting; Nong, Jing-Guo; Li, Tian-De; Wang, Yu

2016-01-01

Objective To evaluate the factors affecting optimal stent expansion in calcified lesions treated by aggressive plaque modification with rotational atherectomy (RA) and a cutting balloon (CB). Methods From January 2014 to May 2015, 92 patients with moderate to severe coronary calcified lesions underwent rotational atherectomy and intravascular ultrasound imaging at Chinese PLA General Hospital (Beijing, China) were included in this study. They were divided into a rotational artherectomy combined with cutting balloon (RACB) group (46 patients treated with RA followed by CB angioplasty) and an RA group (46 patients treated with RA followed by plain balloon angioplasty). Another 40 patients with similar severity of their calcified lesions treated with plain old balloon angioplasty (POBA) were demographically matched to the other groups and defined as the POBA group. All patients received a drug-eluting stent after plaque preparation. Lumen diameter and lumen diameter stenosis (LDS) were measured by quantitative coronary angiography at baseline, after RA, after dilatation, and after stenting. Optimal stent expansion was defined as the final LDS < 10%. Results The initial and post-RA LDS values were similar among the three groups. However, after dilatation, the LDS significantly decreased in the RACB group (from 54.5% ± 8.9% to 36.1% ± 7.1%) but only moderately decreased (from 55.7% ± 7.8% to 46.9% ± 9.4%) in the RA group (time × group, P < 0.001). After stenting, there was a higher rate of optimal stent expansion in the RACB group (71.7% in the RACB group, 54.5% in the RA group, and 15% in the POBA group, P < 0.001), and the final LDS was significantly diminished in the RACB group compared to the other two groups (6.0% ± 2.3%, 10.8% ± 3.3%, 12.7% ± 2.1%, P < 0.001). Moreover, an LDS ≤ 40% after plaque preparation (OR = 2.994, 95% CI: 1.297–6.911) was associated with optimal stent expansion, which also had a positive correlation with the appearance of a calcified ring split (r = 0.581, P < 0.001). Conclusions Aggressive plaque modification with RA and CB achieve more optimal stent expansion. An LDS ≤ 40% after plaque modification was a predictive factor for optimal stent expansion in calcified lesions. This parameter was also associated with the presence of calcified ring split. PMID:28321242

DOE Office of Scientific and Technical Information (OSTI.GOV)

Krokidis, Miltiadis, E-mail: mkrokidis@hotmail.com; Fanelli, Fabrizio; Orgera, Gianluigi

The purpose of this study was to compare the clinical effectiveness of expanded polytetrafluoroethylene/fluorinated-ethylene-propylene (ePTFE/FEP)-covered stents with that of uncovered nitinol stents for the palliation of malignant jaundice caused by inoperable pancreatic head cancer. Eighty patients were enrolled in a prospective randomized study. Bare nitinol stents were used in half of the patients, and ePTFE/FEP-covered stents were used in the remaining patients. Patency, survival, complications, and mean cost were calculated in both groups. Mean patency was 166.0 {+-} 13.11 days for the bare-stent group and 234.0 {+-} 20.87 days for the covered-stent group (p = 0.007). Primary patency rates atmore » 3, 6, and 12 months were 77.5, 69.8, and 69.8% for the bare-stent group and 97.5, 92.2, and 87.6% for the covered-stent group, respectively. Mean secondary patency was 123.7 {+-} 22.5 days for the bare-stent group and 130.3 {+-} 21.4 days for the covered-stent group. Tumour ingrowth occurred exclusively in the bare-stent group in 27.5% of cases (p = 0.002). Median survival was 203.2 {+-} 11.8 days for the bare-stent group and 247.0 {+-} 20 days for the covered-stent group (p = 0.06). Complications and mean cost were similar in both groups. Regarding primary patency and ingrowth rate, ePTFE/FEP-covered stents have shown to be significantly superior to bare nitinol stents for the palliation of malignant jaundice caused by inoperable pancreatic head cancer and pose comparable cost and complications. Use of a covered stent does not significantly influence overall survival rate; nevertheless, the covered endoprosthesis seems to offer result in fewer reinterventions and better quality of patient life.« less

Cost-effectiveness and clinical efficacy of biliary stents in patients undergoing neoadjuvant therapy for pancreatic adenocarcinoma in a randomized controlled trial.

PubMed

Gardner, Timothy B; Spangler, Chad C; Byanova, Katerina L; Ripple, Gregory H; Rockacy, Matthew J; Levenick, John M; Smith, Kerrington D; Colacchio, Thomas A; Barth, Richard J; Zaki, Bassem I; Tsapakos, Michael J; Gordon, Stuart R

2016-09-01

The optimal type of stent for the palliation of malignant biliary obstruction in patients with pancreatic adenocarcinoma undergoing neoadjuvant chemoradiotherapy with curative intent is unknown. We performed a prospective trial comparing 3 types of biliary stents-fully covered self-expandable metal (fcSEMS), uncovered self-expandable metal (uSEMS), and plastic-to determine which best optimized cost-effectiveness and important clinical outcomes. In this prospective randomized trial, consecutive patients with malignant biliary obstruction from newly diagnosed pancreatic adenocarcinoma who were to start neoadjuvant chemoradiotherapy were randomized to receive fcSEMSs, uSEMSs, or plastic stents during the index ERCP. The primary outcomes were time to stent occlusion, attempted surgical resection, or death after the initiation of neoadjuvant therapy, and the secondary outcomes were total patient costs associated with the stent, including the index ERCP cost, downstream hospitalization cost due to stent occlusion, and the cost associated with procedural adverse event. Fifty-four patients were randomized and reached the primary end point: 16 in the fcSEMS group, 17 in the uSEMS group, and 21 in the plastic stent group. No baseline demographic or tumor characteristic differences were noted among the groups. The fcSEMSs had a longer time to stent occlusion compared with uSEMSs and plastic stents (220 vs 74 and 76 days, P < .01), although the groups had equivalent rates of stent occlusion, attempted surgical resection, and death. Although SEMS placement cost more during the index ERCP (uSEMS = $24,874 and fcSEMS = $22,729 vs plastic = $18,701; P < .01), they resulted in higher procedural AE costs per patient (uSEMS = $5522 and fcSEMS = $12,701 vs plastic = $0; P < .01). Conversely, plastic stents resulted in an $11,458 hospitalization cost per patient due to stent occlusion compared with $2301 for uSEMSs and $0 for fcSEMSs (P < .01). In a prospective trial comparing fcSEMSs, uSEMSs, and plastic stents for malignant biliary obstruction in patients undergoing neoadjuvant therapy with curative intent for pancreatic adenocarcinoma, no stent type was superior in optimizing cost-effectiveness, although fcSEMSs resulted in fewer days of neoadjuvant treatment delay and a longer time to stent occlusion. (Clincial trial registration number: NCT01038713.). Copyright © 2016 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

Long-Term Results of Everolimus-Eluting Stents Versus Drug-Eluting Balloons in Patients With Bare-Metal In-Stent Restenosis: 3-Year Follow-Up of the RIBS V Clinical Trial.

PubMed

Alfonso, Fernando; Pérez-Vizcayno, María José; García Del Blanco, Bruno; Otaegui, Imanol; Masotti, Mónica; Zueco, Javier; Veláquez, Maite; Sanchís, Juan; García-Touchard, Arturo; Lázaro-García, Rosa; Moreu, José; Bethencourt, Armando; Cuesta, Javier; Rivero, Fernando; Cárdenas, Alberto; Gonzalo, Nieves; Jiménez-Quevedo, Pilar; Fernández, Cristina

2016-06-27

The aim of this study was to compare the long-term efficacy of everolimus-eluting stents (EES) and drug-eluting balloons (DEB) in patients with bare-metal stent in-stent restenosis (ISR). The relative long-term clinical efficacy of current therapeutic modalities in patients with ISR remains unknown. The 3-year clinical follow-up (pre-specified endpoint) of patients included in the RIBS V (Restenosis Intra-Stent of Bare-Metal Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent Implantation) randomized clinical trial was analyzed. All patients were followed yearly using a pre-defined structured questionnaire. A total of 189 patients with bare-metal stent ISR were allocated to either EES (n = 94) or DEB (n = 95). Clinical follow-up at 1, 2, and 3 years was obtained in all patients (100%). Compared with patients treated with DEB, those treated with EES obtained better angiographic results, including larger minimal luminal diameter at follow-up (primary study endpoint; 2.36 ± 0.6 mm vs. 2.01 ± 0.6 mm; p < 0.001). At 3 years, the rates of cardiac death (2% vs. 1%), myocardial infarction (4% vs. 5%) and target vessel revascularization (9% vs. 5%) were similar in the DEB and EES arms. Importantly, however, at 3 years, the rate of target lesion revascularization was significantly lower in the EES arm (2% vs. 8%; p = 0.04; hazard ratio: 0.23; 95% confidence interval: 0.06 to 0.93). The need for "late" (>1 year) target vessel (3 [3.2%] vs. 3 [3.2%]; p = 0.95) and target lesion (1 [1%] vs. 2 [2.1%]; p = 0.54) revascularization was low and similar in the 2 arms. Rates of definite or probable stent thrombosis (1% vs. 0%) were also similar in the 2 arms. The 3-year clinical follow-up of the RIBS V clinical trial confirms the sustained safety and efficacy of EES and DEB in patients treated for bare-metal stent ISR. In this setting, EES reduce the need for target lesion revascularization at very long-term follow-up. (RIBS V [Restenosis Intra-Stent of Bare Metal Stents: Paclitaxel-Eluting Balloon vs Everolimus-Eluting Stent] [RIBS V]; NCT01239953). Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

[Successful correction with stent-graft of coronary artery rupture after angioplasty].

PubMed

Demin, V V

2003-01-01

Rupture and perforation of coronary arteries complicate in average 0.5% of radiosurgical coronary interventions and often are accompanied by serious consequences and high mortality. According to-type of coronary perforation different methods of correction are used, ranging from conservative measures to urgent cardiosurgical interventions. Coronary stent-grafts with 'sandwich' type of construction ore composed from two metal stents and PTFE layer between them. Development of such stents enabled effective radioguided endovascular repair of coronary ruptures. The paper presents the first Russian experience of stout-graft implantation for coronary artery rupture occurred during direct stenting of proximal anterior descending artery and balloon angioplasty in distal segment. The rupture occurred probably because of wall fragility between affected segment and muscular bridge. Stent-graft JoStent 16 mm in length connected with 3-mm balloon was implanted with subsequent complete restitution of blood flow, resolution of pain syndrome and ECG normalization. Echocardiography in operative theatre and one day after surgery showed no intrapericardial fluid. Stent-graft devices for urgent implantation in cases of coronary rupture must be included into obligatory equipment of radiosurgical facilities.

Biological effect on restenosis and vascular healing of encapsulated paclitaxel nanocrystals delivered via coated balloon technology in the familial hypercholesterolaemic swine model of in-stent restenosis.

PubMed

Cheng, Yanping; Shibuya, Masahiko; McGregor, Jenn; Conditt, Gerard B; Yi, Geng-Hua; Kaluza, Greg L; Gray, William; Doshi, Manish; Sojitra, Prakash; Granada, Juan F

2016-10-20

The aim of this study was to evaluate the biological efficacy of a novel lower-dose (2.5 µg/mm2) encapsulated paclitaxel nanocrystal-coated balloon (Nano-PCB) in the familial hypercholesterolaemic swine (FHS) model of iliofemoral in-stent restenosis. Nano-PCB pharmacokinetics were assessed in 20 femoral arteries (domestic swine). Biological efficacy was evaluated in ten FHS: 14 days following bare metal stent implantation each stent segment was randomised to a clinically available PCB (IN.PACT, n=14), the Nano-PCB (n=14) or an uncoated balloon (n=12). Angiographic, optical coherence tomography and histological evaluation was performed at 28 days after treatment. Arterial paclitaxel concentration was 120.7 ng/mg at one hour and 7.65 ng/mg of tissue at 28 days with the Nano-PCB. Compared to the control uncoated group, both PCBs significantly reduced percent area stenosis (Nano-PCB: 36.0±14.2%, IN.PACT: 29.3±9.2% vs control: 67.9±15.1%, p<0.001). Neointimal distribution in the entire stent length was more homogenous in the Nano-PCB. Histological evaluation showed comparable degrees of neointimal proliferation in both PCBs; however, the Nano-PCB showed slightly higher levels of neointimal maturity and endothelialisation. Lower-dose encapsulated paclitaxel nanocrystals delivered via a coated balloon displayed comparable biological efficacy with superior healing features compared to a clinically validated PCB technology.

Paclitaxel-Eluting Balloon Versus Standard Balloon Angioplasty in In-Stent Restenosis of the Superficial Femoral and Proximal Popliteal Artery: 1-Year Results of the PACUBA Trial.

PubMed

Kinstner, Christian M; Lammer, Johannes; Willfort-Ehringer, Andrea; Matzek, Wolfgang; Gschwandtner, Michael; Javor, Domagoj; Funovics, Martin; Schoder, Maria; Koppensteiner, Renate; Loewe, Christian; Ristl, Robin; Wolf, Florian

2016-07-11

The hypothesis that paclitaxel-eluting balloon angioplasty provides higher 1-year patency rates in femoropopliteal artery in-stent restenosis compared with standard percutaneous transluminal angioplasty (PTA) was tested. Several trials have demonstrated that paclitaxel-eluting balloon angioplasty reduces late luminal loss in comparison with PTA. In a prospective, randomized, single-blind, dual-center study, 74 patients with symptomatic peripheral artery disease due to in-stent restenosis were treated with either paclitaxel-based drug-eluting balloon (DEB) angioplasty (n = 35) or standard PTA (n = 39). Clinical outcomes and patency rates were assessed at 1, 6, and 12 months. The mean lesion length was 17.3 ± 11.3 cm in the DEB group and 18.4 ± 8.8 cm in the PTA group. A single major complication (bleeding) was observed once (1.4%). The mean ankle-brachial index before endovascular treatment was 0.65 ± 0.16 in both groups and 0.79 ± 0.2 versus 0.84 ± 0.3 (p = 0.70, Student t test) in the DEB versus PTA group at 12 months. The 12-month primary patency rates were 40.7% (95% confidence interval [CI]: 0.26 to 0.64) versus 13.4% (95% CI: 0.05 to 0.36) (log-rank p = 0.02) in the DEB versus PTA group. The odds ratio for PTA over DEB angioplasty for experiencing an event was estimated at 2.8 (95% CI: 1.2 to 6.6). Freedom from clinically driven target lesion revascularization was 49.0% (95% CI: 0.32 to 0.75) versus 22.1% (95% CI: 0.10 to 0.48) (log-rank p = 0.11) in the DEB versus PTA group. Clinical improvement by ≥1 Rutherford-Becker category was 68.8% versus 54.5% (p = 0.87) in the DEB versus PTA group at 12 months. When treating peripheral artery disease in patients with in-stent restenosis in the femoropopliteal artery, paclitaxel-eluting balloon angioplasty provides significantly higher patency rates than standard PTA. (Paclitaxel Balloon Versus Standard Balloon in In-Stent Restenoses of the Superficial Femoral Artery [PACUBA I Trial] [PACUBA 1]; NCT01247402). Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Long-Term Primary Patency Rate After Nitinol Self-Expandable Stents Implantation in Long, Totally Occluded Femoropopliteal (TASC II C & D) Lesions.

PubMed

Elmahdy, Mahmoud Farouk; Buonamici, Piergiovanni; Trapani, Maurizio; Valenti, Renato; Migliorini, Angela; Parodi, Guido; Antoniucci, David

2017-06-01

Endovascular therapy for long femoropopliteal lesions using percutaneous transluminal balloon angioplasty or first-generation of peripheral stents has been associated with unacceptable one-year restenosis rates. However, with recent advances in equipment and techniques, a better primary patency rate is expected. This study was conducted to detect the long-term primary patency rate of nitinol self-expandable stents implanted in long, totally occluded femoropopliteal lesions TransAtlantic Inter-Society Census (TASC II type C & D), and determine the predictors of reocclusion or restenosis in the stented segments. The demographics, clinical, anatomical, and procedural data of 213 patients with 240 de novo totally occluded femoropopliteal (TASC II type C & D) lesions treated with nitinol self-expandable stents were retrospectively analysed. Of these limbs, 159 (66.2%) presented with intermittent claudication, while 81 (33.8%) presented with critical limb ischaemia. The mean-time of follow-up was 36±22.6 months, (range: 6.3-106.2 months). Outcomes evaluated were, primary patency rate and predictors of reocclusion or restenosis in the stented segments. The mean age of the patients was 70.9±9.3 years, with male gender 66.2%. Mean pre-procedural ABI was 0.45±0.53. One-hundred-and-seventy-five (73%) lesions were TASC II type C, while 65 (27%) were type D lesions. The mean length of the lesions was 17.9±11.3mm. Procedure related complications occurred in 10 (4.1%) limbs. There was no periprocedural mortality. Reocclusion and restenosis were detected during follow-up in 45 and 30 limbs respectively, and all were re-treated by endovascular approach. None of the patients required major amputation. Primary patency rates were 81.4±1.1%, 77.7±1.9% and 74.4±2.8% at 12, 24, and 36 months respectively. Male gender, severe calcification, and TASC II D lesion were independent predictors for reocclusion, while predictors of restenosis were DM, smoking and TASC II D lesions. Treatment of long, totally occluded femoropopliteal (TASC II C & D) lesions with nitinol self-expandable stents is safe and is associated with highly acceptable long-term primary patency rates. Copyright © 2016 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). Published by Elsevier B.V. All rights reserved.

Endovascular Stenting for Restenosis of the Intracranial Vertebrobasilar Artery After Balloon Angioplasty: Two Case Reports and Review of the Literature

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kiyosue, Hiro, E-mail: hkiyosue@oita-med.ac.jp; Okahara, Mika; Yamashita, Masanori

Percutaneous transluminal balloon angioplasty (PTA) has been used in the treatment of critical stenosis of the intracranial vertebrobasilar artery (VBA). PTA of the intracranial VBA carries the risk of fatal complications such as arterial dissection or acute occlusion as well as postoperative restenosis. The estimated risk of periprocedural complications and restenosis were approximately 20% and 27%. The use of recently developed stents could prevent these problems of PTA. We present two cases of restenosis of the intracranial VBA after PTA which stenoses were successfully retreated with endovascular stenting using flexible coronary stents without any complications. Neither restenosis nor other recurrentmore » symptoms were observed during the 4- and 6-month follow-up period. Reviewing the literature of 33 cases and our 2 cases, the overall complication rates related to stenting and restenosis were 5.6% and 7.8%. Endovascular stenting for the treatment of intracranial VBA can reduce the risk of arterial dissection and restenosis.« less

Arterioureteral Fistula: Treatment of a Hemorrhagic Shock with Massive Hematuria by Placing a Balloon Catheter.

PubMed

Merzeau, Nicolas; Riquet, Hervé; Nicolacopoulos, Ioannis; Alame, Abbas; Larré, Stéphane

2017-01-01

Arterioureteral fistulas (AUF) are serious diseases with increasing incidence. This case report relates the management of AUF in a patient with a history of abdominal oncological surgery, pelvic radiotherapy, and a double J stent in place. The fistula was discovered during a hemorrhagic shock with massive hematuria. The bleeding was controlled by a balloon catheter which led to endovascular treatment consisting of a covered stent.

Arterioureteral Fistula: Treatment of a Hemorrhagic Shock with Massive Hematuria by Placing a Balloon Catheter

PubMed Central

Riquet, Hervé; Nicolacopoulos, Ioannis; Alame, Abbas

2017-01-01

Arterioureteral fistulas (AUF) are serious diseases with increasing incidence. This case report relates the management of AUF in a patient with a history of abdominal oncological surgery, pelvic radiotherapy, and a double J stent in place. The fistula was discovered during a hemorrhagic shock with massive hematuria. The bleeding was controlled by a balloon catheter which led to endovascular treatment consisting of a covered stent. PMID:28465857

Palliative treatment with radiation-emitting metallic stents in unresectable Bismuth type III or IV hilar cholangiocarcinoma.

PubMed

Lu, Jian; Guo, Jin-He; Zhu, Hai-Dong; Zhu, Guang-Yu; Wang, Yong; Zhang, Qi; Chen, Li; Wang, Chao; Pan, Tian-Fan; Teng, Gao-Jun

2017-01-01

The emerging data for stenting in combination with brachytherapy in unresectable hilar cholangiocarcinoma are encouraging. The aim of this study was to evaluate the efficacy and safety of radiation-emitting metallic stents (REMS) for unresectable Bismuth type III or IV hilar cholangiocarcinoma. Consecutive patients who underwent percutaneous placement with REMS or uncovered self-expandable metallic stent (SEMS) for unresectable Bismuth type III or IV hilar cholangiocarcinoma between September 2011 and April 2016 were identified into this retrospective study. Data on patient demographics and overall survival, functional success, stent patency and complications were collected at the authors' hospital. A total of 59 patients were included: 33 (55.9%) in the REMS group and 26 (44.1%) in the SEMS group. The median overall survival was 338 days in the REMS group and 141 days in the SEMS group (p<0.001). The median stent patency time was 385 days for REMS and 142 days for SEMS (p<0.001). The functional success rate (87.9% vs 84.6%, p=0.722) and incidence of overall complications (27.3% vs 26.9%, p=0.999) did not differ in the two groups. Placement with REMS is safe and effective in palliation for unresectable Bismuth type III or IV hilar cholangiocarcinoma, and seems to prolong survival as well as patency of stent in these patients.

The SABRE Trial (Sirolimus Angioplasty Balloon for Coronary In-Stent Restenosis): Angiographic Results and 1-Year Clinical Outcomes.

PubMed

Verheye, Stefan; Vrolix, Mathias; Kumsars, Indulis; Erglis, Andrejs; Sondore, Dace; Agostoni, Pierfrancesco; Cornelis, Kristoff; Janssens, Luc; Maeng, Michael; Slagboom, Ton; Amoroso, Giovanni; Jensen, Lisette Okkels; Granada, Juan F; Stella, Pieter

2017-10-23

The aim of this first-in-human study was to assess the safety and effectiveness of the Virtue sirolimus-eluting balloon in a cohort of patients with in-stent restenosis (ISR). Angioplasty balloons coated with the cytotoxic drug paclitaxel have been widely used for ISR treatment. The Virtue angioplasty balloon (Caliber Therapeutics, New Hope, Pennsylvania) delivers sirolimus in a nanoencapsulated liquid formulation. This clinical trial is the first to examine a sirolimus-eluting balloon for ISR. In this prospective, single-arm feasibility study at 9 European centers, 50 ISR patients were treated with the Virtue balloon. Angiographic measurements at 6 months are reported, along with 12-month clinical follow-up. Procedural success in the intention-to-treat population was 100%. The primary safety endpoint was target lesion failure (TLF) (cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization) assessed at 30 days (0%, n = 50). The primary performance endpoint was in-segment late lumen loss (LLL) at 6 months (0.31 ± 0.52 mm; n = 47). Secondary 6-month endpoints include binary restenosis (19.1%), diameter stenosis (30.3 ± 19.9%), and major adverse cardiac events (MACE) (10.2%, n = 49). In the 36-patient per-protocol population (excluding major protocol violations and previously stented ISR), LLL was 0.12 ± 0.33 mm at 6 months. Clinical outcomes at 1 year for the intention-to-treat group were 12.2% TLF and 14.3% MACE and for the per-protocol population were 2.8% TLF and 2.8% MACE. This first-in-human study showed excellent procedural success for the Virtue sirolimus-eluting angioplasty balloon, 6-month LLL rates in line with current stent-free ISR treatment options, and clinical outcomes that warrant further evaluation in dedicated randomized studies. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

MRSA-infected external iliac artery pseudoaneurysm treated with endovascular stenting.

PubMed

Clarke, M G; Thomas, H G; Chester, J F

2005-01-01

A 48-year-old woman with severe juvenile-onset rheumatoid arthritis presented with a bleeding cutaneous sinus distal to her right total hip replacement scar. Methicillin resistant Staphylococcus aureus (MRSA) was isolated on culture. She had previously undergone bilateral total hip and knee replacements at aged 23 and six years later had the right knee prosthesis removed for infection, with subsequent osteomyelitis of the femoral shaft and right total hip prosthesis disruption. Peripheral arteriography was performed in view of persistent bleeding from the sinus, which revealed a 6 cm false aneurysm filling from and compressing the right external iliac artery (EIA). A PTFE-covered, balloon expandable JOSTENT was deployed in the right EIA, successfully excluding the false aneurysm and preventing further bleeding from the sinus. No graft infection was reported at 12 months. This case illustrates the potential use of endovascular stent-grafting in the treatment of an infected pseudoaneurysm.

MRSA-Infected External Iliac Artery Pseudoaneurysm Treated with Endovascular Stenting

DOE Office of Scientific and Technical Information (OSTI.GOV)

Clarke, M.G.; Thomas, H.G.; Chester, J.F.

2005-04-15

A 48-year-old woman with severe juvenile-onset rheumatoid arthritis presented with a bleeding cutaneous sinus distal to her right total hip replacement scar. Methicillin resistant Staphylococcus aureus (MRSA) was isolated on culture. She had previously undergone bilateral total hip and knee replacements at aged 23 and six years later had the right knee prosthesis removed for infection, with subsequent osteomyelitis of the femoral shaft and right total hip prosthesis disruption. Peripheral arteriography was performed in view of persistent bleeding from the sinus, which revealed a 6 cm false aneurysm filling from and compressing the right external iliac artery (EIA). A PTFE-covered,more » balloon expandable JOSTENT was deployed in the right EIA, successfully excluding the false aneurysm and preventing further bleeding from the sinus. No graft infection was reported at 12 months. This case illustrates the potential use of endovascular stent-grafting in the treatment of an infected pseudoaneurysm.« less

Antral localization worsens the efficacy of enteral stents in malignant digestive tumors.

PubMed

Dolz, Carlos; Vilella, Àngels; González Carro, Pedro; González Huix, Ferran; Espinós, Juan Carlos; Santolaria, Santos; Pérez Roldán, Francisco; Figa, Montserrat; Loras, Carmen; Andreu, Hernán

2011-02-01

Malignant gastric outlet obstruction can be treated by means of enteral stenting or surgical gastrojejunalanatomosis. We evaluated in a prospective and multicentre study the efficacy of the enteral stent on food intake, the quality of life impact, and the relationship between efficacy and determined clinical and technical parameters. Seventy one patients affected by symptoms arising from gastroduodenal obstruction due to malignant tumors, with criteria of irresecability, metastatic disease or very high surgical risk, were treated by means of self expanding metal stents. We used the GOOSS index to evaluate efficacy, and the Euro Qol-5D index to evaluate quality of life. Before stenting patients with GOOSS 0 and 1 were 68 (98.5%). After stenting patients with GOOSS 2 and 3 (semisolid and solid food) were 58 (84,1%) (P<.0001). The Euro Qol-5D index measured before and a month after stenting were 10.17 and 10.04 respectively (P=.6). The median survival was 91 days (9-552). The enteral stents for localised tumors in the duodenum and the gastrojejunalanastomosis were effective in 26 patients (70.2%) and 13 patients respectively (86.6%), while the enteral stents of tumors in the antrum were effective in only 5 patients (29.4%). The palliative treatment of malignant gastric outlet obstruction with a uncovered metal stent produces a significant improvement of oral food intake and maintains the overall quality of life index. The antral localization is associated with a lower efficacy of the procedure. Copyright © 2010 Elsevier España, S.L. All rights reserved.

[Technical feasibility of the implantation of a monorail stent system into the renal arteries without pre-dilatation].

PubMed

Neumann, C; Gschwendtner, M; Karnel, F; Mair, J; Dorffner, G; Dorffner, R

2005-01-01

To evaluate the technical feasibility of the implantation of the monorail RX Herculink system into the renal arteries without pre-dilatation. Forty-two patients (mean age 71 years) from four centers with a total of 44 renal artery stenoses underwent implantation of the RX Herculink stent. The mean grade of the stenosis was 83.8 %, the mean length 7.5 mm. The stenoses were ostial in 38 cases and in immediate proximity to the ostium in 6 cases. The mean follow-up-period was 57 weeks (24 - 176 weeks). In 42 cases, the implantation was successful without pre-dilatation. In 2 cases, pre-dilatation was carried out. In none of the cases, detachment of the stent from the balloon was observed. In one stenosis with a length of 17 mm, implantation of two stents was performed. In 9 cases, post-dilatation with a larger balloon or higher balloon pressure was necessary. Residual stenoses exceeding 30 % were not observed. Two patients developed local bleeding at the puncture site. During the follow-up, restenoses were observed in 5 stents after 26 to 126 weeks, which necessitated a second intervention in 3 cases (PTA in 2 cases, re-stenting in 1 case). The primary patency rate after 6 and 12 months was 0.92 +/- 0.056 according to Kaplan-Meier, the secondary patency rate after 6 and 12 months was 1.0 +/- 0.0. Implantation of the RX Herculink stent system into the renal arteries without pre-dilatation is technically feasible and safe. Even without pre-dilatation, the stent-system can be advanced through the stenosis without detachment. The complication rate is low. Our clinical results are comparable to previous studies.

Management of a traumatic hepatic artery pseudoaneurysm and arterioportal fistula with a combination of a stent graft and coil embolization using flow control with balloon remodeling.

PubMed

Flum, Andrew S; Geiger, James D; Gemmete, Joseph J; Williams, David M; Teitelbaum, Daniel H

2009-10-01

We describe a child who presented with a traumatic hepatic artery pseudoaneurysm and arterioportal fistula, which were subsequently managed with an endovascular stent graft and coil embolization using flow control with balloon remodeling. This case demonstrates a rarely seen condition in the pediatric population and a novel management strategy, which should be considered in the management of this complex injury.

Endoscopically placed stents: a useful alternative for the management of refractory benign cervical esophageal stenosis.

PubMed

Nogales, Óscar; Clemente, Ana; Caballero-Marcos, Aránzazu; García-Lledó, Javier; Pérez-Carazo, Leticia; Merino, Beatriz; López-Ibáñez, María; Pérez Valderas, María Dolores; Bañares, Rafael; González-Asanza, Cecilia

2017-07-01

Benign esophageal strictures are relatively frequent and can severely affect the quality of life of a patient. Stenting has been proposed for the treatment of refractory cases. Lesions affecting the cervical esophagus are more difficult to treat, and the placement of stents in this location has traditionally been restricted due to potential adverse events. The aim of this study was to describe the efficacy and safety of endoscopic stenting in the management of refractory benign cervical esophageal strictures (RBCES) in a single-center cohort study. We analyzed 12 patients with RBCES (Kochman's criteria) and severe dysphagia. We recorded previous endoscopic treatments, stricture characteristics and demographic data. The two types of stents used were fully covered self-expandable metallic stents (FCSEMS) and uncovered biodegradable stents (BDS). FCSEMS were removed eight weeks after placement, and BDS were followed-up until degradation. We assessed technical and clinical success, rate of stricture recurrence and adverse events. The mean age of participants was 64 years (range 30-85). A total of 23 stents (13 FCSEMS and 10 BDS) were placed in 12 patients (median 1.92, range 1-4). The technical success rate was 96% (22/23 stents). Eight patients (66.6%) maintained adequate oral intake at the end of follow-up (median 33.3 months, range 3-84 months). Migration was recorded in 7/23 stents (30.4%) and epithelial hyperplasia in 4/23 stents (17.4%). No severe adverse events were noted. All patients complained of minor cervical pain after placement that was well controlled with mild analgesia. Endoscopic stent therapy seems to be effective and safe in the management of RBCES.

[Early results with a monorail-stent-balloon device for endovascular treatment of renal artery stenosis].

PubMed

Müller-Hülsbeck, S; Jahnke, T; Grimm, J; Behm, C; Hilbert, C; Frahm, C; Biederer, J; Brossmann, J; Heller, M

2002-03-01

To evaluate the technical feasibility of a new monorail-stent-balloon device for treatment of renal artery stenosis (RAS). During a study period of 18 months, 38 patients with proven RAS in 41 cases (hypertension n = 36, renal insufficiency n = 13) and indication for stenting (calicified ostial lesions n = 35, insufficient PTA n = 4, dissection n = 2) were enrolled into this prospective evaluation. Pre-mounted stents (Rx-Herculink(TM) 5 mm = 13, 6 mm = 34, 7 mm = 1) were implanted a transfemoral (n = 35) or transbrachial approach (n = 6). Mean grade and lengths of stenosis measured were 88 % plus minus 10 and 9 mm plus minus 5. Renal stent implantation was technically successful in all cases (100 %). In 7 cases a second stent had to be implanted to cover the entire lesion. The transstenotic pressure drop decreased from 88 mmHg plus minus 10 before to 1 mmHg plus minus 1.8 after the procedure. Remaining stenosis measured 0.7 % plus minus 4.2. Serum creatine levels decreased from 1.9 mm/dl to 1.5 mg/dl (n. s.), blood pressure decreased from 178/94 mmHg to 148/79 mmHg (p < 0.0001) after the intervention. Primary and secondary patency rates at 6 months were 72 % (Standard Error 9.8 %) and 77 (% (Standard Error 9.2 %), respectively. With the used monorail-stend-balloon device a technically easy, secure and exact renal stent placement is guaranteed, patency rates are similar to those described in the current literature.

Very high-pressure dilatation for undilatable coronary lesions: indications and results with a new dedicated balloon.

PubMed

Secco, Gioel Gabrio; Ghione, Matteo; Mattesini, Alessio; Dall'Ara, Gianni; Ghilencea, Liviu; Kilickesmez, Kadriye; De Luca, Giuseppe; Fattori, Rossella; Parisi, Rosario; Marino, Paolo Nicola; Lupi, Alessandro; Foin, Nicolas; Di Mario, Carlo

2016-06-20

Calcific coronary lesions impose a rigid obstacle to optimal balloon and stent expansion and the 20 to 30 atm limit that non-compliant (NC) balloons reach can be insufficient. The aim of our study was to evaluate the safety and efficacy of a new dedicated super high-pressure NC balloon (OPN NC®; SIS Medical AG, Winterthur, Switzerland). We retrospectively evaluated a consecutive series of 91 lesions in which conventional NC balloons at maximal pressure failed to achieve an adequate post-dilatation luminal gain and were therefore treated with an OPN NC balloon up to 40 atm. Angiographic success was defined as residual angiographic diameter stenosis <30%. MLD and %DS were measured at baseline, after NC balloon, OPN NC balloon and stent implantation. Angiographic success was achieved in 84 lesions (92.3%). All of the remaining lesions received rotational atherectomy with the exception of two cases in which rotational atherectomy was not attempted because of small vessel size and excessive tortuosity. MLD and acute gain were significantly greater and %DS was significantly lower post OPN NC balloon compared with conventional NC balloon inflation (p<0.001). No coronary perforations occurred. No acute or 30-day follow-up MACE was reported. When conventional NC balloons fail, the new OPN NC dedicated high-pressure balloon provides an effective and safe alternative strategy for the dilatation of resistant coronary lesions.

A prospective multicenter study on self-expandable metallic stents as a bridge to surgery for malignant colorectal obstruction in Japan: efficacy and safety in 312 patients.

PubMed

Saito, Shuji; Yoshida, Shuntaro; Isayama, Hiroyuki; Matsuzawa, Takeaki; Kuwai, Toshio; Maetani, Iruru; Shimada, Mamoru; Yamada, Tomonori; Tomita, Masafumi; Koizumi, Koichi; Hirata, Nobuto; Kanazawa, Hideki; Enomoto, Toshiyuki; Sekido, Hitoshi; Saida, Yoshihisa

2016-09-01

Endoscopic stenting with a self-expandable metallic stent (SEMS) is a widely accepted procedure for malignant colonic obstruction. The Colonic Stent Safe Procedure Research Group conducted the present prospective feasibility study. Our objectives were to estimate the safety and feasibility of SEMS placement as a bridge to surgery (BTS) for malignant colorectal obstruction. We conducted a prospective, observational, single-arm, multicenter clinical trial from March 2012 to October 2013. Each patient was treated with an uncovered WallFlex enteral colonic stent. Patients were followed up until discharge after surgery. A total of 518 consecutive patients were enrolled in this study. The cohort intended for BTS consisted of 312 patients (61 %), and the stent could be released in 305 patients. Technical and clinical success rates were 98 and 92 %, respectively. Elective surgery was performed in 297 patients, and emergency surgery was performed in eight patients for the treatment of complications. The overall preoperative complication rate was 7.2 %. Major complications, including perforation, occurred in 1.6 %, persistent colonic obstruction occurred in 1.0 %, and stent migration occurred in 1.3 % patients. The median time from SEMS to surgery was 16 days. Silent perforations were observed in 1.3 %. Open and laparoscopic surgery was performed in 121 and 184 patients, respectively. The tumor could be resected in 297 patients. The primary anastomosis rate was 92 %. The rate of anastomotic leakage was 4 %, and the overall stoma creation rate was 10 %. The median duration of hospitalization following surgery was 12 days. Overall postoperative morbidity and mortality rates were 16 and 0.7 %, respectively. This largest, multicenter, prospective study demonstrates the feasibility of SEMS placement as a BTS for malignant colorectal obstruction. SEMS serves as a safe and effective BTS with acceptable stoma creation and complication rates in patients with acute malignant colonic obstruction.

Drug-eluting coronary stents – focus on improved patient outcomes

PubMed Central

Jaffery, Zehra; Prasad, Amit; Lee, John H; White, Christopher J

2011-01-01

The development of stent has been a major advance in the treatment of obstructive coronary artery disease since the introduction of balloon angioplasty. Subsequently, neointimal hyperplasia within the stent leading to in-stent restenosis emerged as a major obstacle in long-term success of percutaneous coronary intervention. Recent introduction of drug-eluting stents is a major breakthrough to tackle this problem. This review article summarizes stent technology, reviews progress of drug-eluting stents and discusses quality of life, patient satisfaction, and acceptability of percutaneous coronary intervention. PMID:22915977

Comparison of the Efficacy of Everolimus-Eluting Stents Versus Drug-Eluting Balloons in Patients With In-Stent Restenosis (from the RIBS IV and V Randomized Clinical Trials).

PubMed

Alfonso, Fernando; Pérez-Vizcayno, María José; García Del Blanco, Bruno; García-Touchard, Arturo; Masotti, Mónica; López-Minguez, José R; Iñiguez, Andrés; Zueco, Javier; Velazquez, Maite; Cequier, Angel; Lázaro-García, Rosa; Martí, Vicens; Moris, César; Urbano-Carrillo, Cristobal; Bastante, Teresa; Rivero, Fernando; Cárdenas, Alberto; Gonzalo, Nieves; Jiménez-Quevedo, Pilar; Fernández, Cristina

2016-02-15

Treatment of patients with in-stent restenosis (ISR) remains a challenge. This study sought to compare the efficacy of everolimus-eluting stents (EESs) and drug-eluting balloons (DEBs) with paclitaxel in patients with ISR. A pooled analysis of the Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent (RIBS IV) and Restenosis Intra-Stent of Bare-Metal Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent (RIBS V) randomized trials was performed using patient-level data. In both trials, EESs were compared with DEBs in patients with ISR (RIBS V included 189 patients with bare-metal ISR; RIBS IV included 309 patients with drug-eluting ISR). Inclusion and exclusion criteria were identical in both trials. A total of 249 patients were allocated to EES and 249 to DEB. Clinical follow-up at 1 year was obtained in all (100%) patients and late angiography (median 249 days) in 91% of eligible patients. Compared with patients treated with DEBs, patients treated with EESs obtained better short-term results (postprocedural minimal lumen diameter 2.28 ± 0.5 vs 2.12 ± 0.4 mm, p <0.0001). At follow-up, patients treated with EESs had larger in-segment minimal lumen diameter (primary end point 2.16 ± 0.7 vs 1.88 ± 0.6 mm, p <0.0001; absolute mean difference 0.28 mm; 95% confidence interval [CI] 0.16 to 0.40) and net lumen gain (1.33 ± 0.6 vs 1.00 ± 0.7 mm, p <0.0001) and had lower %diameter stenosis (19 ± 21% vs 28 ± 22%, p <0.0001) and binary restenosis rate (8.7% vs 15.7%, p = 0.02). Consistent results were observed in the in-lesion analysis. No interactions were found between the underlying stent type and treatment effects. At 1-year clinical follow-up, the composite of cardiac death, myocardial infarction, and target vessel revascularization was significantly reduced in the EES arm (8.8% vs 14.5%, p = 0.03; hazard ratio 0.59, 95% CI 0.31 to 0.94) mainly driven by a lower need for target vessel revascularization (6% vs 12.4%, p = 0.01, hazard ratio 0.46, 95% CI 0.25 to 0.86). This pooled analysis of the RIBS IV and RIBS V randomized trials demonstrates the superiority of EES over DEB in the treatment of patients with ISR. Copyright © 2016 Elsevier Inc. All rights reserved.

A comparison of different transarterial embolization techniques for direct carotid cavernous fistulas: a single center experience in 32 patients

PubMed Central

Lu, Xiaojian; Hussain, Mohammed; Ni, Lanchun; Huang, Qinfeng; Zhou, Fei; Gu, Zhikai; Chen, Jian; Ding, Yuchuan; Xu, Feng

2014-01-01

Objective Transarterial treatment of direct carotid cavernous fistulas (DCCF) via embolic materials has been well documented. This study reports, validates, and compares with existing literature our experience treating DCCFs via endovascular approaches by using detachable balloons, coils, and covered stents. Methods Between June 2006 to October 2011, 32 patients (21 male, 11 female) with 32 DCCFs (30 traumatic, 2 spontaneous cavernous ICA aneurysms) were embolized endovascularly. Followup was performed for at least 6 months. Results Among the 32 DCCFs, 21 (65.6%) were embolized using detachable balloons, eight (25.0%) with coils, one (3.1%) with balloons and coils, and two (6.3%) with covered stents. Complete DCCF obliteration was achieved in 31 (96.9%) cases. One fistula failed to respond due to premature balloon detachment. Intracranial bruit in 31 (100%) chemosis and exophthalmos in 28 (100%) cases resolved after embolization. Visual acuity and oculomotor palsy improved in 18 (90%) and 18 (69.2%) cases, respectively. There was no evidence of DCCF recurrence. Thirteen DCCFs were followed up by MRI and five by DSA. In these cases, four (4/13, 30.8%) balloon-embolized DCCFs showed pseudoaneurysms. Three patients were asymptomatic; one had minor left oculomotor palsy. Conclusions Our results correlate and reinforce literature regarding endovascular treatment of DCCFs. Application of Transarterial embolization with detachable balloons, despite extensive use has been decreasing. Coil embolization is an effective and safe alternative for treatment, especially when balloon embolization fails. Covered stent placement may be used as another alternative for selected cases. PMID:25566340

Stent selection for both biliary and pancreatic strictures caused by chronic pancreatitis: multiple plastic stents or metallic stents?

PubMed

Gupta, Rajesh; Reddy, D Nageshwar

2011-09-01

Endoscopic stenting is an effective treatment option in the management of both benign biliary strictures and pancreatic ductal strictures. Plastic stents and self-expandable metal stents have been used with variable success for the management of both benign biliary strictures and pancreatic ductal strictures caused by chronic pancreatitis. Fully covered self-expandable metal stents of improved design represent a major technological advance which has added to the endoscopic armamentarium. Both multiple plastic stents and covered self-expandable metal stents have shown promising results. However, data to support the use of self-expandable metal stents over multiple plastic stents or vice versa are still lacking.

Comparison of in-hospital and follow-up results of directional atherectomy and stenting for ostial lesions of the left anterior descending coronary artery.

PubMed

Gambhir, D S; Batra, R; Singh, S; Sudha, R; Trehen, V; Arora, R

1998-01-01

Lesions at the ostium of the left anterior descending coronary artery constitute a distinct group because of suboptimal results and higher restenosis rate after balloon angioplasty. Several non-balloon devices have been used to improve the outcome of dilatation of such lesions. We retrospectively compared the in-hospital and follow-up results of directional coronary artherectomy and stents for the treatment of ostial lesions of the left anterior descending artery. Out of 37 patients, 12 underwent directional coronary atherectomy and 25, stent implantation. The two strategies were deployed at different periods over the past five years. The baseline clinical and angiographic characteristics were comparable in the two groups. Directional coronary atherectomy was done using 7Fr atherocath with adjunctive balloon angioplasty in all. All the stents were deployed using moderate to high pressure balloon inflation after adequate predilatation. While the pre-procedure luminal diameter stenosis was similar in the two groups (87.3 +/- 8.8% vs 89.3 +/- 7.2%; p = NS), the residual stenosis was significantly lower in the stent group (5 +/- 2.8%) compared to directional coronary atherectomy (18.7 +/- 9.8; p = 0.02). There was no significant difference in the primary success rate between the two devices (91.6% directional coronary atherectomy vs 100% stent; p = NS). One patient in the directional coronary atherectomy group developed acute closure followed by emergency coronary artery bypass graft surgery and death. No major complication was observed in the stent group. Over a mean follow-up of 9.9 +/- 11.6 months following directional coronary atherectomy and 8.6 +/- 4.4 months after stenting, significantly higher number of patients (60%) developed recurrence of angina or any event following directional coronary atherectomy compared to stent (15.8%; p < 0.02). There was no myocardial infarction, coronary artery bypass graft surgery or death in either group on follow-up. The need for target lesion revascularisation was significantly higher in the directional coronary atherectomy group (50%) compared to stenting (10.5%; p < 0.02). Comparing directional coronary atherectomy with stent, the event-free survival was 80 percent vs 94.7 percent at three months and 50 percent vs 84.7 percent, both at six and nine months, respectively. In conclusion, stenting of the left anterior descending artery ostial lesion results in a significantly lesser post-procedure residual stenosis, improved in-hospital outcome, a lesser need for target lesion revascularisation and much improved event-free survival on follow-up as compared to directional coronary atherectomy. Therefore, stenting appears to be a more favourable treatment option compared to directional coronary atherectomy for the treatment of ostial lesions in the left anterior descending artery.

The added benefits and efficacy of atherectomy in the lower limb.

PubMed

VAN DEN Berg, Jos C

2016-08-01

Atherectomy has been used as an adjunct therapy for balloon angioplasty and/or stent placement in the superficial femoral artery for many years, but has never gained global popularity in the treatment of peripheral arterial disease, most probably related to the conflicting results as published in the literature. Novel techniques that have been developed over the past years are yielding promising results in the infrainguinal region. This paper will describe the added benefits of atherectomy as compared to plain old balloon angioplasty and bail-out bare-metal stenting, both in the treatment of primary lesions of the superficial femoral artery as well as in cases of in-stent restenosis.

Safety of endoscopic removal of self-expandable stents after treatment of benign esophageal diseases.

PubMed

van Halsema, Emo E; Wong Kee Song, Louis M; Baron, Todd H; Siersema, Peter D; Vleggaar, Frank P; Ginsberg, Gregory G; Shah, Pari M; Fleischer, David E; Ratuapli, Shiva K; Fockens, Paul; Dijkgraaf, Marcel G W; Rando, Giacomo; Repici, Alessandro; van Hooft, Jeanin E

2013-01-01

Temporary placement of self-expandable stents has been increasingly used for the management of benign esophageal diseases. To evaluate the safety of endoscopic removal of esophageal self-expandable stents placed for the treatment of benign esophageal diseases. Multicenter retrospective study. Six tertiary care centers in the United States and Europe. A total of 214 patients with benign esophageal diseases undergoing endoscopic stent removal. Endoscopic stent removal. Endoscopic techniques for stent removal, time to stent removal, and adverse events related to stent removal. A total of 214 patients underwent a total of 329 stent extractions. Stents were mainly placed for refractory strictures (49.2%) and fistulae (49.8%). Of the removed stents, 52% were fully covered self-expandable metal stents (FCSEMSs), 28.6% were partially covered self-expandable metal stents (PCSEMSs), and 19.5% were self-expandable plastic stents. A total of 35 (10.6%) procedure-related adverse events were reported, including 7 (2.1%) major adverse events. Multivariate analysis revealed that use of PCSEMSs (P < .001) was a risk factor for adverse events during stent removal. Favorable factors for successful stent removal were FCSEMSs (P ≤ .012) and stent migration (P = .010). No significant associations were found for stent indwelling time (P = .145) and stent embedding (P = .194). Retrospective analysis, only tertiary care centers. With an acceptable major adverse event rate of 2.1%, esophageal stent removal in the setting of benign disease was found to be a safe and feasible procedure. FCSEMSs were more successfully removed than self-expandable plastic stents and PCSEMSs. Adverse events caused by stent removal were not time dependent. Copyright © 2013 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

Revascularization of a thrombosed, previously stented aorto-renal graft using combined directional atherectomy and AngioJet thrombectomy.

PubMed

Seth, A; Mathur, A; Chandra, P; Aggarwal, P; Khanna, N

1999-01-01

We report an interesting case with bilateral PTFE aorto-renal grafts of which one graft underwent balloon angioplasty and stenting for proximal stenosis. Combined debulking by AngioJet thrombectomy and Simpsons directional atherectomy was performed within the stent following reocclusion of the graft 9 months later.

Adjunctive stent use during endovascular intervention to the femoropopliteal artery with drug coated balloons: Insights from the XLPAD registry.

PubMed

Kokkinidis, Damianos G; Jeon-Slaughter, Haekyung; Khalili, Houman; Brilakis, Emmanouil S; Shammas, Nicolas W; Banerjee, Subhash; Armstrong, Ehrin J

2018-06-01

With growing use of drug-coated balloons (DCB) for femoropopliteal (FP) artery interventions, there is limited information on rates of real-world adjunctive stent use and its association with short and long-term outcomes. We report on 225 DCB treated FP lesions in 224 patients from the Excellence in Peripheral Artery Disease (XLPAD) registry (NCT01904851) between 2014 and 2016. Cochran-Mantel-Haenszel and Wilcoxon rank sum statistics were used to compare stented (planned or 'bail-out') versus non-stented DCB treated lesions. Stents were implanted in 31% of FP DCB interventions. Among the 70 stents implanted, 46% were for 'bail-out' indications and 54% were planned. Lesions treated with stents were longer (mean 150 mm vs 100 mm; p < 0.001) and less likely to be in-stent restenosis lesions (10% vs 28%; p=0.003). Stenting was significantly more frequent in complex FP lesions, including chronic total occlusions (66% vs 34%; p < 0.001). For bail-out stenting, interwoven nitinol stents were the most common type (50%) followed by drug-eluting stents (34%) and bare-metal stents (22%). There were no differences in peri-procedural complication rates or 12-month target limb revascularization rates (18.6% vs 11.6%; p=0.162) or 12-month amputation rates (11.4% vs 11%; p=0.92) between lesions where adjunctive stenting was used versus lesions without adjunctive stenting, respectively. In conclusion, in a contemporary 'real-world' adjudicated multicenter US registry, adjunctive stenting was necessary in nearly a third of the lesions, primarily for the treatment of more complex FP lesions, with similar short and intermediate-term clinical outcomes compared with non-stented lesions.

One Year Outcomes of 101 BeGraft Stent Grafts used as Bridging Stents in Fenestrated Endovascular Repairs.

PubMed

Spear, Rafaelle; Sobocinski, Jonathan; Hertault, Adrien; Delloye, Matthieu; Azzauiu, Richard; Fabre, Dominique; Haulon, Stéphan

2018-04-01

To evaluate the outcomes of the second generation BeGraft balloon expandable covered stent Graft System (Bentley InnoMed, Hechingen, Germany) implanted as bridging stent grafts during fenestrated endovascular aortic repair (FEVAR) of complex aneurysms. This was a single centre prospective study including all consecutive patients treated by FEVAR performed with second generation BeGraft stent grafts as bridging stents. Demographics of patients, diameter and length of the bridging stent grafts, technical success, re-interventions, occlusions, post-operative events, and imaging (Cone Beam CT and/or CT scan, and contrast enhanced ultrasound) were prospectively collected in an electronic database. Duplex ultrasound was performed before discharge and at 6 month follow-up. At 1 year, patients were evaluated clinically and by imaging (CT and ultrasound). Between November 2015 and September 2016, 39 consecutive patients (one woman) were treated with custom made fenestrated endografts (2-5 fenestrations) for complex aneurysms or type 1 endoleak after EVAR, using a variety of bridging stents including the BeGraft. All 101 BeGraft stent grafts were successfully delivered and deployed. There was no in hospital mortality. Early fenestration patency rate was 99% (96/97); the sole target vessel post-operative occlusion was secondary to a dissection of the renal artery distal to the stent. Complementary stenting was unsuccessful in recovering renal artery patency; bilateral renal stent occlusion was observed in the same patient on a CT scan performed 2 months after the procedure. He required post-operative dialysis. No additional renal impairment was observed. During follow-up (median 13 months [11-15]), all fenestrations stented with BeGraft stent grafts remained patent (95/97, 98%). One type 1b endoleak was detected and treated (2.6%). BeGraft stent grafts used as bridging stents during FEVAR are associated with favourable outcomes at 1 year follow-up. Long-term follow-up is required to confirm these promising results. Copyright © 2018 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.

The current role of vascular stents.

PubMed

Busquet, J

1993-09-01

The limitations of percutaneous balloon angioplasty have favoured the development and the use of vascular endoprostheses or stents. These thin-walled metal devices maintain after expansion, an optimal and constant diameter for the vascular lumen. Restenosis, dissection, abrupt closure, residual stenosis or re-opened total occlusion represent appropriate indications for stenting. A large experience with non-coronary application of stents is currently available in iliac, femoro-popliteal and renal arteries, aorta, large veins.

BIODEGRADABLE BILIARY STENTS: A NEW APPROACH FOR THE MANAGEMENT OF HEPATICOJEJUNOSTOMY STRICTURES FOLLOWING BILE DUCT INJURY. PROSPECTIVE STUDY

PubMed Central

GIMÉNEZ, Mariano E.; PALERMO, Mariano; HOUGHTON, Eduardo; ACQUAFRESCA, Pablo; FINGER, Caetano; VERDE, Juan M.; CÚNEO, Jorge Cardoso

2016-01-01

ABSTRACT Background: Once a biliary injury has occurred, repair is done by a hepaticojejunostomy. The most common procedure is to perform a dilatation with balloon with a success of 70 %. Success rates range using biodegradable stents is from 85% to 95%. Biodegradable biliary stents should change the treatment of this complication. Aim: To investigate the use of biodegradable stents in a group of patients with hepaticojejunonostomy strictures. Methods: In a prospective study 16 biodegradable stents were placed in 13 patients with hepaticojejunostomy strictures secondary to bile duct repair of a biliary surgical injury. Average age was 38.7 years (23-67), nine were female and four male. All cases had a percutaneous drainage before at the time of biodegradable stent placement. Results: In one case, temporary haemobilia was present requiring blood transfusion. In another, pain after stent placement required intravenous medication. In the other 11 patients, hospital discharge was the next morning following stent placement. During the patient´s follow-up, none presented symptoms during the first nine months. One patient presented significant alkaline phosphatase elevation and stricture recurrence was confirmed. One case had recurrence of cholangitis 11 months after the stent placement. 84.6% continued asymptomatic with a mean follow-up of 20 months. Conclusion: The placement of biodegradable stents is a safe and feasible technique. Was not observed strictures caused by the stent or its degradation. It could substitute balloon dilation in strictures of hepaticojejunostomy. PMID:27438039

Drug‐coated balloons for de novo lesions in small coronary arteries: rationale and design of BASKET‐SMALL 2

PubMed Central

Gilgen, Nicole; Farah, Ahmed; Scheller, Bruno; Ohlow, Marc‐Alexander; Mangner, Norman; Weilenmann, Daniel; Wöhrle, Jochen; Jamshidi, Peiman; Leibundgut, Gregor; Möbius‐Winkler, Sven; Zweiker, Robert; Krackhardt, Florian; Butter, Christian; Bruch, Leonhard; Kaiser, Christoph; Hoffmann, Andreas; Rickenbacher, Peter; Mueller, Christian; Stephan, Frank‐Peter; Coslovsky, Michael

2018-01-01

The treatment of coronary small vessel disease (SVD) remains an unresolved issue. Drug‐eluting stents (DES) have limited efficacy due to increased rates of instent‐restenosis, mainly caused by late lumen loss. Drug‐coated balloons (DCB) are a promising technique because native vessels remain structurally unchanged. Basel Stent Kosten‐Effektivitäts Trial: Drug‐Coated Balloons vs. Drug‐Eluting Stents in Small Vessel Interventions (BASKET‐SMALL 2) is a multicenter, randomized, controlled, noninferiority trial of DCB vs DES in native SVD for clinical endpoints. Seven hundred fifty‐eight patients with de novo lesions in vessels <3 mm in diameter and an indication for percutaneous coronary intervention such as stable angina pectoris, silent ischemia, or acute coronary syndromes are randomized 1:1 to angioplasty with DCB vs implantation of a DES after successful initial balloon angioplasty. The primary endpoint is the combination of cardiac death, nonfatal myocardial infarction, and target‐vessel revascularization up to 1 year. Secondary endpoints include stent thrombosis, Bleeding Academic Research Consortium (BARC) type 3 to 5 bleeding, and long‐term outcome up to 3 years. Based on clinical endpoints after 1 year, we plan to assess the noninferiority of DCB compared to DES in patients undergoing primary percutaneous coronary intervention for SVD. Results will be available in the second half of 2018. This study will compare DCB and DES regarding long‐term safety and efficacy for the treatment of SVD in a large all‐comer population. PMID:29527709

Safety and efficacy of rotational atherectomy for the treatment of undilatable underexpanded stents implanted in calcific lesions.

PubMed

Ferri, Luca A; Jabbour, Richard J; Giannini, Francesco; Benincasa, Susanna; Ancona, Marco; Regazzoli, Damiano; Mangieri, Antonio; Montorfano, Matteo; Colombo, Antonio; Latib, Azeem

2017-08-01

Coronary stent underexpansion is a known risk factor for in-stent restenosis and stent thrombosis. There are limited options once noncompliant balloons have failed to achieve optimal stent expansion. Excimer Laser Coronary Angioplasty with contrast medium injection is one possibility, but not readily available. Rotational atherectomy is an alternative, and has been described in case reports, but concerns exist regarding safety. All consecutive patients undergoing rotational atherectomy for symptomatic in-stent restenosis due to stent underexpansion resistant to noncompliant balloon postdilatation between January 2005 and December 2015 were analysed. A total of 16 patients underwent treatment during the study period and the procedure was successful in 14 cases (87.5%). The mean postprocedural minimal lumen diameter increased by 2.3 ± 0.8 mm and percentage diameter stenosis decreased from 82.17% ± 17.2% to 11.9% ± 9.1%. Intraprocedural complications occurred in two patients (burr entrapment successfully managed percutaneously and periprocedural myocardial infarction). At 1-year follow-up, the incidence of target lesion revascularisation was 13.3% (2 out of 15 patients), and one patient died from noncardiac death. In this small series of underexpanded stents, rotational atherectomy was an effective treatment for resistant stent underexpansion with acceptable outcomes. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Development of a functionalized polymer for stent coating in the arterial delivery of small interfering RNA.

PubMed

San Juan, Aurélie; Bala, Madiha; Hlawaty, Hanna; Portes, Patrick; Vranckx, Roger; Feldman, Laurent J; Letourneur, Didier

2009-11-09

In patients receiving drug eluting stents, there is a growing concern about both the long-term toxicity/degradability of the polymers used for the coating, and the nature of the therapeutic agents. We hypothesized that the use of a functionalized biocompatible polymer for a stent coating could be appropriate for local arterial therapy. A cationized pullulan hydrogel was thus prepared to cover bare metal stents that could be further loaded with small interfering RNA (siRNA) targeted at MMP2 for gene silencing in vascular cells. The efficient coverage of the stent struts by a smooth polymeric layer, which can withstand the crimping of the stent on a balloon-catheter and its deployment, was demonstrated by fluorescence microscopy, scanning electron microscopy, and atomic force microscopy. The release of siRNA from the stents was modulated by the presence of the cationic groups, as compared to noncationized pullulan hydrogel. In vivo implantation of coated stents was successful and cationized pullulan-based hydrogels loaded with siRNA in rabbit balloon-injured carotid arteries induced an uptake of siRNA into the arterial wall and a decrease of pro-MMP2 activity. These results suggest that cationized pullulan-based hydrogel could be used as a new biocompatible and biodegradable stent coating for local gene therapy in the arterial wall.

A Pilot Study of Open Venous Revascularization using Expandable PTFE Stent Grafts in a Porcine (Sus scrofa) Model

DTIC Science & Technology

2017-05-23

expandable stent -grafts that are designed to expand within a vessel to cover an injury or open a blockage. Methods: 3 Yorkshire cross swine were...expandable PTFE stent graft was deployed into the vessel in an open direct fashion. The swine were awoken and allowed to ambulate. At 72 hours, conduit...hours, all stents were patent on venography. Conclusion: Direct site endovascular repair of venous injuries utilizing expandable PTFE stent grafts is a

Difficult removal of fully covered self expandable metal stents (SEMS) for benign biliary strictures: the "SEMS in SEMS" technique.

PubMed

Tringali, Andrea; Blero, Daniel; Boškoski, Ivo; Familiari, Pietro; Perri, Vincenzo; Devière, Jacques; Costamagna, Guido

2014-06-01

Removal of biliary Fully Covered Self Expandable Metal Stents can fail due to stent migration and/or hyperplastic ingrowth/overgrowth. A case series of 5 patients with benign biliary strictures (2 post-cholecystectomy, 2 following liver transplantation and 1 related to chronic pancreatitis) is reported. The biliary stricture was treated by temporary insertion of Fully Covered Self Expandable Metal Stents. Stent removal failed due to proximal stent migration and/or overgrowth. Metal stent removal was attempted a few weeks after the insertion of another Fully Covered Metal Stent into the first one. The inner Fully Covered Self Expandable Metal Stent compressed the hyperplastic tissue, leading to the extraction of both the stents in all cases. Two complications were reported as a result of the attempt to stents removal (mild pancreatitis and self-limited haemobilia). In the present series, the "SEMS in SEMS" technique revealed to be effective when difficulties are encountered during Fully Covered Self Expandable Metal Stents removal. Copyright © 2014 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

The role of airway stenting in pediatric tracheobronchial obstruction.

PubMed

Antón-Pacheco, Juan L; Cabezalí, Daniel; Tejedor, Raquel; López, María; Luna, Carmen; Comas, Juan V; de Miguel, Eduardo

2008-06-01

Tracheobronchial obstruction is infrequent in the pediatric age group but it is associated with significant morbidity and mortality. The purpose of this study is to review the results of a single institution experience with endoscopic stent placement in children with benign tracheobronchial obstruction, and with special concern on safety and clinical effectiveness. Twenty-one patients with severe airway stenosing disease in which stent placement was performed between 1993 and 2006. Inclusion criteria according to the clinical status were: failure to wean from ventilation, episode of apnea, frequent respiratory infections (>3 pneumonia/year), and severe respiratory distress. Additional criteria for stent placement were: failure of surgical treatment, bronchomalacia, and tracheomalacia refractory to previous tracheostomy. Selection of the type of stent depended on the site of the lesion, the patient's age, and the stent availability when time of presentation. The following variables were retrospectively evaluated: age, type of obstruction, associated malformations, stent properties, technical and clinical success, complications and related reinterventions, outcome and follow-up period. Thirty-three stents were placed in the trachea (n=18) and/or bronchi (n=15) of 21 patients with a median age of 6 months (range, 9 days-19 years). Etiology of the airway obstruction included severe tracheomalacia and/or bronchomalacia in 19 cases (90%), and postoperative tracheal stenosis in two. Twelve children had a total of 20 balloon-expandable metallic stents placed, and 10 had 13 silicone-type stents (one patient had both). In nine patients (42%) more than one device was placed. Stent positioning was technically successful in all but one patient. Clinical improvement was observed in 18 patients (85%) but complications occurred in five of them (27%). Eight patients died during follow-up but only in one case it was related to airway stenting. Thirteen patients (62%) are alive and in good condition with a mean follow-up of 39 months (1-13.8 years). Although the results were based on a small series, placement of stents in the pediatric airway to treat tracheobronchial obstruction seems to be safe and effective. Stenting is a satisfactory therapeutic option when other procedures have failed or are not indicated.

Evaluation of anti-migration properties of biliary covered self-expandable metal stents.

PubMed

Minaga, Kosuke; Kitano, Masayuki; Imai, Hajime; Harwani, Yogesh; Yamao, Kentaro; Kamata, Ken; Miyata, Takeshi; Omoto, Shunsuke; Kadosaka, Kumpei; Sakurai, Toshiharu; Nishida, Naoshi; Kudo, Masatoshi

2016-08-14

To assess anti-migration potential of six biliary covered self-expandable metal stents (C-SEMSs) by using a newly designed phantom model. In the phantom model, the stent was placed in differently sized holes in a silicone wall and retracted with a retraction robot. Resistance force to migration (RFM) was measured by a force gauge on the stent end. Radial force (RF) was measured with a RF measurement machine. Measured flare structure variables were the outer diameter, height, and taper angle of the flare (ODF, HF, and TAF, respectively). Correlations between RFM and RF or flare variables were analyzed using a linear correlated model. Out of the six stents, five stents were braided, the other was laser-cut. The RF and RFM of each stent were expressed as the average of five replicate measurements. For all six stents, RFM and RF decreased as the hole diameter increased. For all six stents, RFM and RF correlated strongly when the stent had not fully expanded. This correlation was not observed in the five braided stents excluding the laser cut stent. For all six stents, there was a strong correlation between RFM and TAF when the stent fully expanded. For the five braided stents, RFM after full stent expansion correlated strongly with all three stent flare structure variables (ODF, HF, and TAF). The laser-cut C-SEMS had higher RFMs than the braided C-SEMSs regardless of expansion state. RF was an important anti-migration property when the C-SEMS did not fully expand. Once fully expanded, stent flare structure variables plays an important role in anti-migration.

Saphenous Vein Graft Perforation During Percutaneous Coronary Intervention - A Nightmare to be Avoided.

PubMed

Deora, Surender; Shah, Sanjay C; Patel, Tejas M

2015-01-01

Percutaneous coronary interventions (PCIs) of saphenous vein grafts (SVGs) is challenging and is associated with adverse short- and long-term clinical outcome as compared to native coronary arteries. SVG perforation is rare but catastrophic and needs immediate attention. Various factors predisposing for SVG perforation are old degenerated graft, ulcerated plaque, severe fibrotic, or calcified lesion necessitating high pressure balloon or stent inflation, use of intravascular ultrasound (IVUS) or other atheroablative devices. Management includes prolonged balloon occlusion, reversal of anticoagulation, use of covered stent, and emergency pericadiocentesis if required.

Evaluation of a fully covered self-expanding metal stent with flared ends in malignant biliary obstruction: a multicenter study.

PubMed

Kahaleh, Michel; Talreja, Jayant P; Loren, David E; Kowalski, Thomas E; Poneros, John M; Degaetani, Marisa; Raijman, Isaac; Sejpal, Divyesh V; Patel, Sandeep; Rosenkranz, Lauren; McNamara, Kevin N; Brijbassie, Alan; Wang, Andrew Y; Gaidhane, Monica; Sethi, Amrita; Stevens, Peter D

2013-01-01

Limited data are available regarding fully covered metal stents in the management of malignant distal biliary strictures. The aim of this study was to evaluate the safety of a fully covered self-expanding metal stent (FCSEMS) with flared ends, in treating malignant biliary strictures. We report our long-term retrospective analysis from 6 centers. A total of 260 patients (142 males, median age 68 y) underwent endoscopic retrograde cholangiopancreatography with placement of FCSEMS (WallFlex; Boston Scientific, Natick, MA) for the palliation of obstructive jaundice in the setting of pancreatic adenocarcinoma (169), metastatic disease (36), cholangiocarcinoma (23), ampullary cancer (19), or other (13). Patients were evaluated clinically in follow-up and biochemical tests of liver function were obtained. Data were recorded for the following variables: patient survival, duration of stent patency, the need for subsequent biliary intervention, and complications. A total of 266 FCSEMS were placed in 260 patients. There was a median survival of 100 days (range, 7 to 531 d). There was a mean follow-up of 134±118 days (range, 4 to 519 d). Biliary decompression was successful in 252 patients (97%). At the end of the study period, 121 were alive with a patent stent, 65 patients died with a patent stent, 40 patients were successfully bridged to surgery, 8 patients had their patent stent removed and had no need for further stenting, and 18 patients were lost to follow-up. Five patients who had a successfully placed FCSEMS were considered a failure due to the following reason: migration (2), cholangitis (1), stent occlusion (1), and removal for management of proximal biliary obstruction (1). Two additional patients experienced migration that did not require FCSEMS removal or replacement. Stent replacement was required in 10 patients, of whom 6 had a second FCSEMS placed. The remaining 4 were in the failure group and underwent replacement with either uncovered stents or plastic stents. Other complications, managed conservatively, included pain (2), postendoscopic retrograde cholangiopancreatography pancreatitis (4), fever (1), retroperitoneal perforation (1), and postsphincterotomy bleeding (1). The mean patency duration was 328 days (SE 19.04). The patency percentage was 83% at 3 months, 63% at 6 months, and 48.5% at 12 months. In the management of malignant distal biliary strictures, the fully covered WallFlex stent has acceptable patency and complication rates. Further long-term prospective data are required to confirm this observation.

Complications of stent placement in patients with esophageal cancer: A systematic review and network meta-analysis

PubMed Central

Doosti-Irani, Amin; Mansournia, Mohammad Ali; Rahimi-Foroushani, Abbas; Haddad, Peiman

2017-01-01

Background Palliative treatments and stents are necessary for relieving dysphagia in patients with esophageal cancer. The aim of this study was to simultaneously compare available treatments in terms of complications. Methods Web of Science, Medline, Scopus, Cochrane Library and Embase were searched. Statistical heterogeneity was assessed using the Chi2 test and was quantified by I2. The results of this study were summarized in terms of Risk Ratio (RR). The random effects model was used to report the results. The rank probability for each treatment was calculated using the p-score. Results Out of 17855 references, 24 RCTs reported complications including treatment related death (TRD), bleeding, stent migration, aspiration, severe pain and fistula formation. In the ranking of treatments, thermal ablative therapy (p-score = 0.82), covered Evolution® stent (p-score = 0.70), brachytherapy (p-score = 0.72) and antireflux stent (p-score = 0.74) were better treatments in the network of TRD. Thermal ablative therapy (p-score = 0.86), the conventional stent (p-score = 0.62), covered Evolution® stent (p-score = 0.96) and brachytherapy (p-score = 0.82) were better treatments in the network of bleeding complications. Covered Evolution® (p-score = 0.78), uncovered (p-score = 0.88) and irradiation stents (p-score = 0.65) were better treatments in network of stent migration complications. In the network of severe pain, Conventional self-expandable nitinol alloy covered stent (p-score = 0.73), polyflex (p-score = 0.79), latex prosthesis (p-score = 0.96) and brachytherapy (p-score = 0.65) were better treatments. Conclusion According to our results, thermal ablative therapy, covered Evolution® stents, brachytherapy, and antireflux stents are associated with a lower risk of TRD. Moreover, thermal ablative therapy, conventional, covered Evolution® and brachytherapy had lower risks of bleeding. Overall, fewer complications were associated with covered Evolution® stent and brachytherapy. PMID:28968416

Apollo stent for symptomatic atherosclerotic intracranial stenosis: study results.

PubMed

Jiang, W-J; Xu, X-T; Jin, M; Du, B; Dong, K-H; Dai, J-P

2007-05-01

A recent trial shows an 8.3 per 100-patient-years' ischemic stroke rate in the territory of the intracranial stenotic artery, despite aspirin treatment. Our aim was to prospectively study the feasibility and outcome of a new intracranial balloon-expandable Apollo stent for symptomatic atherosclerotic intracranial stenosis (SAIS). Forty-six patients (41 men and 5 women; median, 54 years of age) with forty-eight >or=50% SAISs were enrolled. Procedural feasibility was evaluated by stent success (residual stenosis or=24 months), which varied from 1 month to 30.7 months (median, 23.9 months). After 30 days, 1 patient (2.2%, 1/46) developed minor stroke in the target-lesion artery territory at 6.7 months. Primary end point rate was 4.3 per 100 patient years. Angiographic follow-up was performed in 25 patients. Seven restenoses (28%, 7/25) were detected, 1 of which was symptomatic. Angioplasty with the Apollo stent for symptomatic atherosclerotic intracranial stenosis is feasible. Severe tortuosity is an independent predictor of stent failure. Our clinical outcome seems to compare favorably with results of aspirin therapy, but the restenotic rate was high.

[Numerical modeling of shape memory alloy vascular stent's self-expandable progress and "optimized grid" of stent].

PubMed

Xu, Qiang; Liu, Yulan; Wang, Biao; He, Jin

2008-10-01

Vascular stent is an important medical appliance for angiocardiopathy. Its key deformation process is the expandable progress of stent in the vessel. The important deformation behaviour corresponds to two mechanics targets: deformation and stress. This paper is devoted to the research and development of vascular stent with proprietary intellectual property rights. The design of NiTinol self-expandable stent is optimized by means of finite element software. ANSYS is used to build the finite element simulation model of vascular stent; the molding material is NiTinol shape memory alloy. To cope with the factors that affect the structure of stent, the shape of grid and so on, the self-expanding process of Nitinol stent is simulated through computer. By making a comparison between two kinds of stents with similar grid structure, we present a new concept of "Optimized Grid" of stent.

Laser Fenestration of Aortic Stent-Grafts Followed by Noncompliant vs Cutting Balloon Dilation: A Scanning Electron Microscopy Study.

PubMed

Lin, Jing; Parikh, Niraj; Udgiri, Naval; Wang, Shaoxia; Miller, Daniel F; Li, Chaojing; Panneton, Jean; Nutley, Mark; Zhang, Ze; Huang, Yunfan; Lu, Jun; Zhang, Jingyi; Wang, Lu; Guidoin, Robert

2018-06-01

To examine the effects of in situ laser fenestration and subsequent balloon dilation (noncompliant vs cutting) on the graft fabric of 4 aortic stent-graft models. In an in vitro setup, the Zenith TX2, Talent, Endurant, and Anaconda aortic stent-grafts (all made of polyester graft material) were subjected to laser fenestration with a 2.3-mm-diameter probe at low and high energy in a physiologic saline solution followed by balloon dilation of the hole. For the first series of tests, 6-mm-diameter noncompliant balloons were used and replaced for the second series by 6-mm-diameter cutting balloons. Each procedure was performed 5 times (5 fenestrations per balloon type). The fenestrations were examined visually and with light and scanning electron microscopy. Each fenestration demonstrated various degrees of fraying and/or tearing regardless of the device. The monofilament twill weave of the Talent endograft tore in the warp direction up to 7.09±0.46 mm at high energy compared with 2.41±0.26 mm for the Endurant multifilament device. The fenestrations of the 3 endografts with multifilament weave (Zenith, Anaconda, and Endurant) showed more fraying; fenestration areas in the multifilament Endurant were >10 mm 2 at low and high energy. The fenestrations were free of melted fibers, but minor blackening of the filaments was observed in all devices. Overall, the cutting balloons resulted in worse tearing and damage. Of note, the edges of the dilated laser-formed fenestrations of the Talent and the Endurant grafts demonstrated evidence of additional shredded yarns. In situ fenestration does not cause any melting of the polyester; however, the observed structural damage to the fabric construction must be carefully considered. Cutting balloons caused various levels of tearing compared to the noncompliant balloons and cannot be recommended for use in this application. Rather, noncompliant balloons should be employed, but only with endografts constructed from multifilament yarns. The use of in situ fenestration must be restricted to urgent and emergent cases until long-term durability can be determined.

Evaluation of anti-migration properties of biliary covered self-expandable metal stents

PubMed Central

Minaga, Kosuke; Kitano, Masayuki; Imai, Hajime; Harwani, Yogesh; Yamao, Kentaro; Kamata, Ken; Miyata, Takeshi; Omoto, Shunsuke; Kadosaka, Kumpei; Sakurai, Toshiharu; Nishida, Naoshi; Kudo, Masatoshi

2016-01-01

AIM: To assess anti-migration potential of six biliary covered self-expandable metal stents (C-SEMSs) by using a newly designed phantom model. METHODS: In the phantom model, the stent was placed in differently sized holes in a silicone wall and retracted with a retraction robot. Resistance force to migration (RFM) was measured by a force gauge on the stent end. Radial force (RF) was measured with a RF measurement machine. Measured flare structure variables were the outer diameter, height, and taper angle of the flare (ODF, HF, and TAF, respectively). Correlations between RFM and RF or flare variables were analyzed using a linear correlated model. RESULTS: Out of the six stents, five stents were braided, the other was laser-cut. The RF and RFM of each stent were expressed as the average of five replicate measurements. For all six stents, RFM and RF decreased as the hole diameter increased. For all six stents, RFM and RF correlated strongly when the stent had not fully expanded. This correlation was not observed in the five braided stents excluding the laser cut stent. For all six stents, there was a strong correlation between RFM and TAF when the stent fully expanded. For the five braided stents, RFM after full stent expansion correlated strongly with all three stent flare structure variables (ODF, HF, and TAF). The laser-cut C-SEMS had higher RFMs than the braided C-SEMSs regardless of expansion state. CONCLUSION: RF was an important anti-migration property when the C-SEMS did not fully expand. Once fully expanded, stent flare structure variables plays an important role in anti-migration. PMID:27570427

Debulking Atherectomy in the Peripheral Arteries: Is There a Role and What is the Evidence?

PubMed

Katsanos, Konstantinos; Spiliopoulos, Stavros; Reppas, Lazaros; Karnabatidis, Dimitris

2017-07-01

Traditional percutaneous balloon angioplasty and stent placement is based on mechanical plaque disruption and displacement within the arterial wall. On the contrary, transcatheter atherectomy achieves atherosclerotic plaque clearance by means of directional plaque excision or rotational plaque removal or laser plaque ablation. Debulking atherectomy may allow for a more uniform angioplasty result at lower pressures with consequently less vessel barotrauma and improved luminal gain, thereby decreasing the risk of plaque recoil and dissection that may require permanent metal stenting. It has been also argued that atherectomy may disrupt the calcium barrier and optimize drug transfer and delivery in case of drug-coated balloon applications. The authors discuss the various types of atherectomy devices available in clinical practice to date and critically appraise their mode of action as well as relevant published data in each case. Overall, amassed randomized and observational evidence indicates that percutaneous atherectomy of the femoropopliteal and infrapopliteal arteries may achieve high technical success rates and seems to lessen the frequency of bailout stenting, however, at the expense of increased risk of peri-procedural distal embolization. Long-term clinical outcomes reported to date do not support the superiority of percutaneous atherectomy over traditional balloon angioplasty and stent placement in terms of vessel patency or limb salvage. The combination of debulking atherectomy and drug-coated balloons has shown promise in early studies, especially in the treatment of more complex lesions. Unanswered questions and future perspectives of this continuously evolving endovascular technology as part of a broader treatment algorithm are discussed.

A critical view of the peripheral atherectomy data in the treatment of infrainguinal arterial disease.

PubMed

Quevedo, Henry C; Arain, Salman A; Ali, Gholam; Abi Rafeh, Nidal

2014-01-01

Revascularization of the peripheral arteries remains technically challenging. By decreasing the volume of the atherosclerotic plaque, debulking procedures may confer superior primary patency after revascularization. To assess the impact of atherectomy on primary patency rates at 12 months compared to balloon angioplasty and/or stent placement alone in patients with infrainguinal arterial disease. A database search for "directional," "orbital," "rotational," and "laser atherectomy" in peripheral arterial disease (PAD) was performed. Studies were screened according to the STROBE (Strengthening the Reporting of Observational studies in Epidemiology) critical appraisal tool and summarized by population, methodology, and outcomes (primary patency and major adverse events). Only two randomized studies were found. Most of the data were obtained from single-arm studies and registries. The primary patency with directional atherectomy approaches 60% at 12 months as a stand-alone technique, whereas orbital atherectomy in conjunction with balloon angioplasty and stenting achieved primary patency rates of 90%. Laser atherectomy is universally employed with balloon angioplasty and stenting for in-stent restenosis lesions with a primary patency rate of 64%. Although there are data for the safe use of rotational atherectomy, robust data to support its effectiveness are lacking. The combination of drug-coated balloons and atherectomy for the treatment of heavily calcified lesions in patients with critical limb ischemia is under evaluation. Despite the successful procedural outcomes reported in clinical registries, the available data do not support the use of atherectomy alone in PAD. Larger randomized controlled studies are warranted to define its role in contemporary endovascular practice.

Drug-coated balloons for de novo lesions in small coronary arteries: rationale and design of BASKET-SMALL 2.

PubMed

Gilgen, Nicole; Farah, Ahmed; Scheller, Bruno; Ohlow, Marc-Alexander; Mangner, Norman; Weilenmann, Daniel; Wöhrle, Jochen; Jamshidi, Peiman; Leibundgut, Gregor; Möbius-Winkler, Sven; Zweiker, Robert; Krackhardt, Florian; Butter, Christian; Bruch, Leonhard; Kaiser, Christoph; Hoffmann, Andreas; Rickenbacher, Peter; Mueller, Christian; Stephan, Frank-Peter; Coslovsky, Michael; Jeger, Raban

2018-05-01

The treatment of coronary small vessel disease (SVD) remains an unresolved issue. Drug-eluting stents (DES) have limited efficacy due to increased rates of instent-restenosis, mainly caused by late lumen loss. Drug-coated balloons (DCB) are a promising technique because native vessels remain structurally unchanged. Basel Stent Kosten-Effektivitäts Trial: Drug-Coated Balloons vs. Drug-Eluting Stents in Small Vessel Interventions (BASKET-SMALL 2) is a multicenter, randomized, controlled, noninferiority trial of DCB vs DES in native SVD for clinical endpoints. Seven hundred fifty-eight patients with de novo lesions in vessels <3 mm in diameter and an indication for percutaneous coronary intervention such as stable angina pectoris, silent ischemia, or acute coronary syndromes are randomized 1:1 to angioplasty with DCB vs implantation of a DES after successful initial balloon angioplasty. The primary endpoint is the combination of cardiac death, nonfatal myocardial infarction, and target-vessel revascularization up to 1 year. Secondary endpoints include stent thrombosis, Bleeding Academic Research Consortium (BARC) type 3 to 5 bleeding, and long-term outcome up to 3 years. Based on clinical endpoints after 1 year, we plan to assess the noninferiority of DCB compared to DES in patients undergoing primary percutaneous coronary intervention for SVD. Results will be available in the second half of 2018. This study will compare DCB and DES regarding long-term safety and efficacy for the treatment of SVD in a large all-comer population. © 2018 The Authors. Clinical Cardiology published by Wiley Periodicals, Inc.

Cerebrospinal fluid enhancement on fluid attenuated inversion recovery images after carotid artery stenting with neuroprotective balloon occlusions: hemodynamic instability and blood-brain barrier disruption.

PubMed

Ogami, Ryo; Nakahara, Toshinori; Hamasaki, Osamu; Araki, Hayato; Kurisu, Kaoru

2011-10-01

A rare complication of carotid artery stenting (CAS), prolonged reversible neurological symptoms with delayed cerebrospinal fluid (CSF) space enhancement on fluid attenuated inversion recovery (FLAIR) images, is associated with blood-brain barrier (BBB) disruption. We prospectively identified patients who showed CSF space enhancement on FLAIR images. Nineteen patients-5 acute-phase and 14 scheduled-underwent 21 CAS procedures. Balloon catheters were navigated across stenoses, angioplasty was performed using a neuroprotective balloon, and stents were placed with after dilation under distal balloon protection. CSF space hyperintensity or obscuration on FLAIR after versus before CAS indicated CSF space enhancement. Correlations with clinical factors were examined. CSF space was enhanced on FLAIR in 12 (57.1%) cases. Postprocedural CSF space enhancement was significantly related to age, stenosis rate, acute-stage procedure, and total occlusion time. All acute-stage CAS patients showed delayed enhancement. Only age was associated with delayed CSF space enhancement in scheduled CAS patients. Ischemic intolerance for severe carotid artery stenosis and temporary neuroprotective balloon occlusion, causing reperfusion injury, seem to be the main factors that underlie BBB disruption with delayed CSF space enhancement shortly after CAS, rather than sudden poststenting hemodynamic change. Our results suggest that factors related to hemodynamic instability or ischemic intolerance seem to be associated with post-CAS BBB vulnerability. Patients at risk for hemodynamic instability or with ischemic intolerance, which decrease BBB integrity, require careful management to prevent intracranial hemorrhagic and other post-CAS complications.

Role of laser photoablative therapy and expandable metal stents in colorectal carcinoma

NASA Astrophysics Data System (ADS)

Chennupati, Raja S.; Trowers, Eugene A.

2000-05-01

Metallic stents are effective in relieving colorectal obstruction in more than 80% of cases. Self expanding metallic stents allow for decompression of the proximal colon and preoperative bowel cleansing. Hence, emergent surgery for large bowel obstruction with its associated high morbidity and mortality might be avoided. Endoscopic laser photoablation and stent placement may successfully palliate inoperable colorectal cancer patients by maintaining luminal patency and avoiding the need for a colostomy. Major complications associated with metallic stents include pressure necrosis, perforation, bleeding and migration. The effectiveness of expandable metallic stents in obstructive colorectal carcinoma is critically reviewed. The authors present a concise review of the effectiveness of endoscopic laser photoablation and expandable metal stent placement.

Functional Self-Expandable Metal Stents in Biliary Obstruction

PubMed Central

Kwon, Chang-Il; Ko, Kwang Hyun; Hahm, Ki Baik

2013-01-01

Biliary stents are widely used not only for palliative treatment of malignant biliary obstruction but also for benign biliary diseases. Each plastic stent or self-expandable metal stent (SEMS) has its own advantages, and a proper stent should be selected carefully for individual condition. To compensate and overcome several drawbacks of SEMS, functional self-expandable metal stent (FSEMS) has been developed with much progress so far. This article looks into the outcomes and defects of each stent type for benign biliary stricture and describes newly introduced FSEMSs according to their functional categories. PMID:24143314

Safety and efficacy of self-expandable metal stents for obstructive proximal and distal large bowel cancer.

PubMed

Mitra, V; Hu, M; Majumdar, D; Krishnan, V; Chaudhury, B; Hancock, J; Dwarakanath, D

2017-03-01

Self-expandable metal stents are often used to treat obstructive large bowel cancers. This study assessed the safety and efficacy of colonic stent insertion carried out in a district general hospital. Methods A retrospective review was carried out between 1 January 2007 and 28 February 2014 to identify patients who underwent stent insertion for malignant colorectal obstruction. Results Seventy-five patients (median age 75.2 years, 70.6% male) with primary colorectal cancer underwent stent insertion - 53 underwent semi-elective self-expanded metal stent insertion (for subacute bowel obstruction) and 22 had emergency stent inserted (for acute bowel obstruction). The majority (88%) had self-expanded metal stents inserted for palliation. Technical and clinical success rates were 98.7% and 91.2%, respectively. One patient had stent-related perforation; there was no procedure-related mortality. Conclusion This study shows that self-expanded metal stent insertion in malignant colorectal obstruction is safe and effective and can be successfully delivered in a district general hospital with high technical and clinical success rates.

A new self-expandable aortic valved stent deployed above native leaflets for aortic insufficiency: an in vitro study.

PubMed

Huang, H; Zhou, Y; Shao, J; Cai, J; Mei, Y; Wang, Y

2012-12-01

The aim of this paper was to develop a new self-expandable aortic valved stent following the shape of the sinus of Valsalva, which can be deployed above native leaflets for aortic regurgitation, and study it's effect on coronary artery flow when orthotopic implantation in and above native leaflets. New self-expandable aortic valved stent consist of nitinol stent and bovine pericardium, and was designed following the shape of the sinus of Valsalva, the bovine pericardium was tailed as native leaflet. Thirty-six swine hearts were divided into three equal groups of twelve. In Group A (N.=12), the new self-expandable aortic valved stents deployed in native leaflets. In Group B (N.=12), the new self-expandable aortic valved stents deployed above native leaflets. In Group C (N.=12), the cylinder-like valved stents deployed only in native leaflets. The measurements of each coronary flow rate and endoscopic inspections were repeated post-implantation. In Group A and C, valve implantation in native leaflets resulted in a significant decrease in both left and right coronary flows. In Group B, no significant change in either right or left coronary flow was found after new self-expandable aortic valved stent placement. Endoscopic inspections showed that in group A and C the native leaflets sandwiched between valved stent and aortic wall, whereas, in group B the native leaflets were under the artificial leaflets. Two kinds of stents deployed in native leaflets affect left and right coronary flows significantly. No significant effect was found when the new self-expandable aortic valved stent deployed above native leaflets. This new self-expandable aortic valved stent can be deployed above the native leaflets, which avoids the obstruction of native leaflets on coronary flow.

Can you score with balloons to enhance outcomes after drug coated balloon angioplasty? Insights from the Paris DCB Registry for in-stent restenosis.

PubMed

Merat, Benoît; Waliszewski, Matthias; Dillinger, Guillaume; Henry, Patrick; Sideris, Georgios

2018-06-01

The objective of this study was to assess the 12-month clinical outcomes in patients with drug-eluting stent in-stent restenosis (DES-ISR) who were either pre-dilated with non-compliant balloons (NCBA) and with additional scoring balloons (NCBA + SBA) prior to drug coated balloon (DCB) angioplasty. This monocentric, retrospective study included patients with DES-ISR who were routinely treated over a 2-year time span. Patients with stable angina and documented ischemia or selected forms of unstable angina due to a culprit DES-ISR lesion were analyzed. The primary endpoint was the clinically driven target-lesion revascularization (TLR) rate at 12 months. Secondary endpoints included post-interventional lumen gain and late lumen loss (LLL) at 6 months. The 12-month TLR rates in 124 patients who underwent either NCBA + SBA or NCBA only group were not different (17.3%, 9/52 vs 11.6%, 8/69, P = 0.371) and low as compared to other comparable studies. The use of SBA led to equally high post minimal lumen diameters (MLD) in both treatment arms (NCBA 2.21 ± 0.33 vs NCBA + SBA 2.18 ± 0.41, P = 0.868). We did not find a significant difference in late lumen loss (LLL) between both groups (0.50 ± 0.62 mm vs 0.40 ± 0.46 mm, P = 0.468). Scoring Balloon Angioplasty can safely and effectively prepare DES-ISR lesions to render them suitable for DCB angioplasty with acceptable TLR and MACE rates. © 2018, Wiley Periodicals, Inc.

Endoscopic stenting as bridge-to-surgery (BTS) in left-sided obstructing colorectal cancer: Experience with conformable stents.

PubMed

Parodi, Andrea; De Ceglie, Antonella; De Luca, Luca; Conigliaro, Rita; Naspetti, Riccardo; Arpe, Paola; Coccia, Gianni; Conio, Massimo

2016-11-01

Compared to emergency surgery, self-expandable metallic stents are effective and safe when used as bridge-to-surgery (BTS) in operable patients with acute colorectal cancer obstruction. In this study, we report data on the new conformable colonic stents. To evaluate clinical effectiveness of conformable stents as BTS in patients with acute colorectal cancer obstruction. This was a retrospective study. The study was conducted at six Italian Endoscopic Units. Data about patients with acute malignant colorectal obstruction were collected between 2007 and 2012. All patients were treated with conformable stents as BTS. Technical success, clinical success, rate of primary anastomosis and colostomy, early and late complications were evaluated. Data about 88 patients (62 males) were reviewed in this study. Conformable SEMS were correctly deployed in 86 out of 88 patients, with resolution of obstruction in all treated patients. Tumor resection with primary anastomosis was possible in all patients. A temporary colostomy was performed in 40. Early complications did not occur. Late complications occurred in 11 patients. Stent migration was significantly higher in patients treated with partially-covered stents compared to the uncovered group (35% vs. 0%, P<0.001). Endoscopical re-intervention was required in 12% of patients. One patient with rectal cancer had an anastomotic dehiscence after surgery and he was successfully treated with endoscopic clipping. One year after surgery, all patients were alive and local recurrence have not been documented. This was a retrospective and uncontrolled study. Preliminary data from this large case series are encouraging, with a high rate of technical and clinical success and low rate of clinically relevant complications. Partially-covered SEMS should be avoided in order to reduce the risk of endoscopic re-intervention. Copyright © 2016. Published by Elsevier Masson SAS.

Stenting of long coronary artery lesions: initial angiographic results and 6-month clinical outcome of the micro stent II-XL.

PubMed

Schalij, M J; Udayachalerm, W; Oemrawsingh, P; Jukema, J W; Reiber, J H; Bruschke, A V

1999-09-01

To evaluate the results of long Micro Stent II (MS-XL) implantations, 119 MS-XLs were implanted in 102 patients (age, 62.83 years). Nineteen stents (16%) were implanted in saphenous vein grafts; 100 stents (84%) were implanted in native coronary arteries. Twenty-five patients (25%) were treated because of acute myocardial infarction (AMI); 30 patients (29%) because of unstable angina or angina class IV, and 47 patients (46%) because of stable angina. Eighty-six de novo lesions (84%) and 16 restenotic lesions (16%) were treated. Indications for stent implantation include elective, 61 patients (60%); suboptimal balloon angioplasty result, 22 patients (21%); and bailout after balloon angioplasty, 19 patients (19%). Because of residual thrombus after stenting, 27 patients (26%) received abciximab. All patients received ticlopidin for 28 days and acetylsalicylic acid. One hundred and seventeen MS-XLs (98%) were implanted successfully. Additional (shorter) MS-II were implanted in 40 patients (39%). The stented segment length was 45 +/- 20 mm. The minimum lumen diameter increased from 0.5 +/- 0.5 mm before to 2.7 +/- 0.5 mm after stent implantation. The acute gain was 2.2 +/- 0.4 mm. Early clinical events (<4 weeks) include death, 3 (3%); subacute stent thrombosis, 1 (1%); non-Q-wave infarction, 2 (2%); CABG, 1 (1%); vascular complications, 2 (2%). Late clinical events (<6 months) include acute myocardial infarction, 5 (5%); reintervention, 6 (6%); CABG, 1 (1%). The procedural success rate was 88%, and the event free survival at 6 months was 76%. Stenting of long lesions with the MS-XL was successful and associated with an acceptable complication rate. Cathet. Cardiovasc. Intervent. 48:105-112, 1999. Copyright 1999 Wiley-Liss, Inc.

Reliable porcine coronary model of chronic total occlusion using copper wire stents and bioabsorbable levo-polylactic acid polymer.

PubMed

Sim, Doo Sun; Jeong, Myung Ho; Cha, Kyoung Rae; Park, Suk Ho; Park, Jong Oh; Shin, Young Min; Shin, Heungsoo; Hong, Young Joon; Ahn, Youngkeun; Schwartz, Robert S; Kang, Jung Chaee

2012-12-01

Chronic total occlusion (CTO) remains a challenge in interventional cardiology. We investigated the feasibility and reliability of copper wire stents and levo-polylactic acid (l-PLA) as a means of CTO induction in a porcine model. In one group of 20 swine, copper stents were crimped on a 3.0mm angioplasty balloon and inserted into the mid-left anterior descending coronary artery (LAD). In the other group of 20 swine, l-PLA was wrapped on a guidewire and pushed into the distal LAD with a 3.0mm balloon catheter to induce embolization. Of 20 swine which underwent copper stent implantation, 13 died of stent thrombosis. In the remaining 7 swine, total or near total occlusion with collateral circulation was observed at 5 weeks. Of 20 swine which underwent l-PLA embolization, 4 died of ventricular fibrillation during or shortly after the procedure. Serial histopathologic studies showed complete absorption of the polymer with replacement by fibrotic tissue approximately 4 weeks following the polymer implantation. CTO could be reliably induced in porcine coronary arteries by copper stents and l-PLA. These models may support investigation of new percutaneous devices to facilitate CTO interventions. Copyright © 2012 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

Indication for percutaneous aortic valve implantation

PubMed Central

Akin, Ibrahim; Kische, Stephan; Rehders, Tim C.; Nienaber, Christoph A.; Rauchhaus, Mathias; Schneider, Henrik; Liebold, Andreas

2010-01-01

The incidence of valvular aortic stenosis has increased over the past decades due to improved life expectancy. Surgical aortic valve replacement is currently the only treatment option for severe symptomatic aortic stenosis that has been shown to improve survival. However, up to one third of patients who require lifesaving surgical aortic valve replacement are denied surgery due to high comorbidities resulting in a higher operative mortality rate. In the past such patients could only be treated with medical therapy or percutaneous aortic valvuloplasty, neither of which has been shown to improve mortality. With advances in interventional cardiology, transcatheter methods have been developed for aortic valve replacement with the goal of offering a therapeutic solution for patients who are unfit for surgical therapy. Currently there are two catheter-based treatment systems in clinical application (the Edwards SAPIEN aortic valve and the CoreValve ReValving System), utilizing either a balloon-expandable or a self-expanding stent platform, respectively. PMID:22371763

The role of stents in the treatment of Crohn’s disease strictures

PubMed Central

Loras Alastruey, Carme; Andújar Murcia, Xavier; Esteve Comas, Maria

2016-01-01

Background and aims: Stenosis is one of the most frequent local complications in Crohn’s disease (CD). Surgery is not the ideal treatment because of the high rate of postoperative recurrence. Endoscopic balloon dilation (EBD) currently is the current treatment of choice for short strictures amenable to the procedure. However, it is not applicable or effective in all the cases, and it is not without related complications. Our goal was to summarize the published information regarding the use and the role of the stents in the treatment of CD stricture. A Medline search was performed on the terms “stricture,” “stenosis,” “stent” and “Crohn’s disease.” Results: a total of 19 publications met our search criteria for an overall number of 65 patients. Placing a self-expanding metal stent (SEMS) may be a safe and effective alternative to EBD and/or surgical intervention in the treatment of short stenosis in patients with CD. Indications are the same as those for EBD. In addition, SEMS may be useful in stenosis refractory to EBD and may be suitable in the treatment of longer or more complex strictures that cannot be treated by EBD. With the current information, it seems that the best treatment option is the placement of a fully covered stent for a mean time of 4 weeks. Regarding the use of biodegradable stents, the information is limited and showing poor results. Conclusions: the use of stents in the treatment of strictures in CD should be taken into account either as a first endoscopic therapy or in case of EBD failure. PMID:27014743

[Baloon angioplasty with stent implantation in recoarctation of the aorta: an attractive alternative].

PubMed

Saliba, Z; Aggoun, Y; Iserin, L; Massih, T A; Bonnet, D; Acar, P; Mousseaux, E; Sidi, D; Kachaner, J; Bonhoeffer, P

2001-05-01

The results of transcatheter balloon angioplasty in teenagers and adults with aortic recoarctation are uncertain. Therefore, there is a current trend to prefer a more complex procedure including the implantation of a stent. This study deals with 8 patients aged 7 to 25.3 years (median: 15 years), weighing 20 to 68 kg. (median: 57) and having undergone resection of an aortic coarctation during infancy (24 days to 4 years). All had their lower limb pulses diminished or abolished, elevated blood pressure at rest (and at exercise in the 5 tested patients), and left ventricular hypertrophy. MRI documented the lesion and helped to select seven patients whose stenosis was short and remote enough from the origin of the main aortic collateral. In one case, the decision to stent was taken as an emergent measure to treat an aortic dissection which appeared shortly after balloon dilatation. The effectiveness of the procedure was immediate in all patients with a 50% increase in diameter of the dilated area, total relief of the gradient, drop to normal values of the blood pressure. These good results persisted at follow-up (3-24 months) in 6 patients, with moderate hypertensive rebounds in the last 2. There were 2 technical problems (premature burst of the balloon, asymmetrical inflation of the stent like an "Eiffel Tower") that could finally be overcome and should no longer occur with the new specially designed so-called "BIB" balloons. Would long term follow-up confirm these early results, one should conclude that this method offers an attractive, safe and effective option to surgery for adolescents and adults with late recoarctation of the aorta.

Critical appraisal of paclitaxel balloon angioplasty for femoral–popliteal arterial disease

PubMed Central

Herten, Monika; Torsello, Giovanni B; Schönefeld, Eva; Stahlhoff, Stefan

2016-01-01

Peripheral arterial disease, particularly critical limb ischemia, is an area with urgent need for optimized therapies because, to date, vascular interventions often have limited life spans. In spite of initial encouraging technical success after femoropopliteal percutaneous transluminal angioplasty or stenting, postprocedural restenosis remains the major problem. The challenging idea behind the drug-coated balloon (DCB) concept is the biological modification of the injury response after balloon dilatation. Antiproliferative drugs administered via DCBs or drug-eluting stents are able to suppress neointimal hyperplasia, the main cause of restenosis. This article reviews the results of DCB treatments of femoropopliteal and infrapopliteal lesions in comparison to standard angioplasty with uncoated balloons. A systematic literature search was performed in 1) medical journals (ie, MEDLINE), 2) international registers for clinical studies (ie, www.clinicaltrials.gov), and 3) abstracts of scientific sessions. Several controlled randomized trials with follow-up periods of up to 5 years demonstrated the efficacy of paclitaxel –DCB technology. However, calcified lesions seem to affect the efficacy of DCB. Combinations of preconditioning methods with DCBs showed promising results. Although the mechanical abrasion of calcium via atherectomy or laser ablation showed favorable periprocedural results, the long-term impact on restenosis and clinical outcome has to be demonstrated. Major advantages of the DCBs are the rapid delivery of drug at uniform concentrations with a single dose, their efficacy in areas wherein stents have been contraindicated until now (ie, bifurcation, ostial lesions), and in leaving no stent scaffold behind. Reinterventions are easier to perform because DCBs leave no metal behind. Various combinations of DCBs with other treatment modalities may prove to be viable options in future. The follow-up results of clinical studies will evaluate the long-term impact of DCBs. PMID:27621646

The efficacy and safety of drug-eluting balloons for the treatment of in-stent restenosis as compared with drug-eluting stents and with conventional balloon angioplasty

PubMed Central

Oh, Pyung Chun; Suh, Soon Yong; Kang, Woong Chol; Lee, Kyounghoon; Han, Seung Hwan; Ahn, Taehoon; Shin, Eak Kyun

2016-01-01

Background/Aims: Treatment of coronary in-stent restenosis (ISR) is still associated with a high incidence of recurrence. We aimed to compare the efficacy and safety of drug-eluting balloons (DEB) for the treatment of ISR as compared with conventional balloon angioplasty (BA) and drug-eluting stents (DES). Methods: Between January 2006 and May 2012 a total of 177 patients (188 lesions, 64.1 ± 11.7 years old) who underwent percutaneous coronary intervention for ISR were retrospectively enrolled. Clinical outcomes were compared between patients treated with DEB (n = 58, 32.8%), conventional BA (n = 65, 36.7%), or DES (n = 54, 30.5%). The primary end point was a major adverse cardiac event (MACE), defined as a composite of cardiac death, myocardial infarction, and target lesion revascularization(TLR). Results: Baseline characteristics were not different except for a history of previous MI, which was more frequent in patients treated by conventional BA or DES than in patients treated by DEB (40.0% vs. 48.1% vs. 17.2%, respectively, p = 0.002). The total incidences of MACEs were 10.7%, 7.4%, and 15.4% in patients treated by DEB, DES, or conventional BA, respectively (p > 0.05). TLR was more frequent in patients treated by conventional BA than in patients treated by DEB or DES, but this was not statistically significant (10.8% vs. 6.9% vs. 3.7%, p > 0.05 between all group pairs, respectively). Conclusions: This study showed that percutaneous coronary intervention using DEB might be a feasible alternative to conventional BA or DES implantation for treatment of coronary ISR. Further large-scaled, randomized study assessing long-term clinical and angiographic outcomes will be needed. PMID:26951915

Critical appraisal of paclitaxel balloon angioplasty for femoral-popliteal arterial disease.

PubMed

Herten, Monika; Torsello, Giovanni B; Schönefeld, Eva; Stahlhoff, Stefan

2016-01-01

Peripheral arterial disease, particularly critical limb ischemia, is an area with urgent need for optimized therapies because, to date, vascular interventions often have limited life spans. In spite of initial encouraging technical success after femoropopliteal percutaneous transluminal angioplasty or stenting, postprocedural restenosis remains the major problem. The challenging idea behind the drug-coated balloon (DCB) concept is the biological modification of the injury response after balloon dilatation. Antiproliferative drugs administered via DCBs or drug-eluting stents are able to suppress neointimal hyperplasia, the main cause of restenosis. This article reviews the results of DCB treatments of femoropopliteal and infrapopliteal lesions in comparison to standard angioplasty with uncoated balloons. A systematic literature search was performed in 1) medical journals (ie, MEDLINE), 2) international registers for clinical studies (ie, www.clinicaltrials.gov), and 3) abstracts of scientific sessions. Several controlled randomized trials with follow-up periods of up to 5 years demonstrated the efficacy of paclitaxel -DCB technology. However, calcified lesions seem to affect the efficacy of DCB. Combinations of preconditioning methods with DCBs showed promising results. Although the mechanical abrasion of calcium via atherectomy or laser ablation showed favorable periprocedural results, the long-term impact on restenosis and clinical outcome has to be demonstrated. Major advantages of the DCBs are the rapid delivery of drug at uniform concentrations with a single dose, their efficacy in areas wherein stents have been contraindicated until now (ie, bifurcation, ostial lesions), and in leaving no stent scaffold behind. Reinterventions are easier to perform because DCBs leave no metal behind. Various combinations of DCBs with other treatment modalities may prove to be viable options in future. The follow-up results of clinical studies will evaluate the long-term impact of DCBs.

Cerebrospinal Fluid Enhancement on Fluid Attenuated Inversion Recovery Images After Carotid Artery Stenting with Neuroprotective Balloon Occlusions: Hemodynamic Instability and Blood-Brain Barrier Disruption

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ogami, Ryo, E-mail: ogami.r@mazda.co.jp; Nakahara, Toshinori; Hamasaki, Osamu

2011-10-15

Purpose: A rare complication of carotid artery stenting (CAS), prolonged reversible neurological symptoms with delayed cerebrospinal fluid (CSF) space enhancement on fluid attenuated inversion recovery (FLAIR) images, is associated with blood-brain barrier (BBB) disruption. We prospectively identified patients who showed CSF space enhancement on FLAIR images. Methods: Nineteen patients-5 acute-phase and 14 scheduled-underwent 21 CAS procedures. Balloon catheters were navigated across stenoses, angioplasty was performed using a neuroprotective balloon, and stents were placed with after dilation under distal balloon protection. CSF space hyperintensity or obscuration on FLAIR after versus before CAS indicated CSF space enhancement. Correlations with clinical factors weremore » examined. Results: CSF space was enhanced on FLAIR in 12 (57.1%) cases. Postprocedural CSF space enhancement was significantly related to age, stenosis rate, acute-stage procedure, and total occlusion time. All acute-stage CAS patients showed delayed enhancement. Only age was associated with delayed CSF space enhancement in scheduled CAS patients. Conclusions: Ischemic intolerance for severe carotid artery stenosis and temporary neuroprotective balloon occlusion, causing reperfusion injury, seem to be the main factors that underlie BBB disruption with delayed CSF space enhancement shortly after CAS, rather than sudden poststenting hemodynamic change. Our results suggest that factors related to hemodynamic instability or ischemic intolerance seem to be associated with post-CAS BBB vulnerability. Patients at risk for hemodynamic instability or with ischemic intolerance, which decrease BBB integrity, require careful management to prevent intracranial hemorrhagic and other post-CAS complications.« less

One Year Clinical Outcomes of Renal Artery Stenting: The Results of ODORI Registry

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sapoval, M., E-mail: marc.sapoval2@egp.aphp.f; Tamari, I.; Goffette, P.

2010-06-15

The safety, efficacy and long term clinical benefits of renal artery revascularization by stenting are still a matter of debate. The aim of our study was to define the safety and efficacy of renal artery stenting with the Tsunami peripheral stent (Terumo Corporation, Tokyo, Japan). The ODORI was a prospective, multicentre registry which enrolled 251 consecutive patients, (276 renal arteries) in 36 centres across Europe. The primary endpoint was acute procedural success defined as <30% residual stenosis after stent placement. Secondary endpoints included major adverse events, blood pressure control, serum creatinine level, and target lesion revascularization (TLR) at 6 andmore » 12 months. Patients were 70 {+-} 10 years old, 59% were male, 33% had diabetes, and 96% hypertension. The main indications for renal stent implantation were hypertension in 83% and renal salvage in 39%. Direct stent implantation was performed in 76% of the cases. Acute success rate was 100% with residual stenosis of 2.5 {+-} 5.4%. Systolic/diastolic blood pressure decreased from a mean of 171/89 at baseline to 142/78 mmHg at 6 months (p < 0.0001 vs. baseline), and 141/80 mmHg at 12 months (p < 0.0001 vs. baseline). Mean serum creatinine concentration did not change significantly in the total population. However, there was significant improvement in the highest tercile (from 283 {mu}mol/l at baseline to 205 and 209 {mu}mol/l at 6 and 12 months respectively). At 12-months, rates of restenosis and TLR were 6.6 and 0.8% respectively. The 12 month cumulative rate of all major clinical adverse events was 6.4% while the rate of device or procedure related events was 2.4%. In hypertensive patients with atherosclerotic renal artery stenosis Tsunami peripheral balloon-expandable stent provides a safe revascularization strategy, with a potential beneficial impact on hypertension control and renal function in the highest risk patients.« less

Technical and Clinical Results After Percutaneous Angioplasty in Nonmedial Fibromuscular Dysplasia: Outcome After Endovascular Management of Unifocal Renal Artery Stenoses in 30 Patients

DOE Office of Scientific and Technical Information (OSTI.GOV)

Barrier, Pierre, E-mail: p.barrier@gmail.com; Julien, Auriol; Guillaume, Canevet

2010-04-15

Although percutaneous transluminal renal angioplasty (PTRA) is associated with excellent results in medial fibromuscular dysplasia (FMD), the clinical and technical outcome in the less common nonmedial subtype of FMD is not clearly known. Angiographic PTRA results and clinical follow-up were documented, to report technical and clinical results in 30 patients with unifocal, nonmedial dysplastic stenoses. Balloon angioplasty was technically successful in only 65% of the lesions. Additional stenting, performed after PTRA failure in six patients, increased the initial technical success rate to 82%. Stenting was used in another lesion after restenosis, and long-term patency was achieved in only three ofmore » the seven stented lesions. Frequent restenoses and unusual complications were observed during follow-up. Stent fracture occurred in two cases. Overall, long-term clinical and technical successes were sustained in 70 and 76%, respectively. We conclude that nonmedial, unifocal renal artery dysplastic stenoses do not share the excellent prognosis of the medial type and that stenting should be avoided. Therefore, surgery should be considered in lesions remaining unresponsive to balloon dilatation, after a second PTRA attempt.« less

Endoscopic treatment of large pancreatic fluid collections (PFC) using self-expanding metallic stents (SEMS) - a two-center experience.

PubMed

Chaves, Dalton Marques; Mönkemüller, Klaus; Carneiro, Fred; Medrado, Bruno; Dos Santos, Marcos; Wodak, Stephanie; Reimão, Sílvia; Sakai, Paulo; de Moura, Eduardo

2014-12-01

Background/study aim: During the last several years, endoscopic ultrasound (EUS)-guided pancreatic fluid collections' (PFC) drainage has evolved into the preferred drainage technique. Recently, self-expanding metallic stents (SEMS) have been used as an alternative to double pigtail stents, with the advantage of providing a larger diameter fistula, thereby decreasing the risk of early obstruction and also allowing for direct endoscopic exploration of the cavity. The aim of this study was to evaluate the technical and clinical success, safety, and outcome of patients undergoing EUS-guided drainage of complex PFC using SEMS. The study was conducted at two tertiary hospitals from January 2010 to January 2013. All patients with PFC referred for endoscopic drainage were enrolled in a prospective database. The inclusion criteria were: (1) patients with pseudocysts or walled-off necrosis based on the revised Atlanta classification; (2) symptomatic patients with thick PFC; (3) PFC that persisted more than 6 weeks; and (4) large PFC diameter (≥ 9 cm). The exclusion criteria consisted of coagulation disorders, PFC bleeding or infection, and failure-to-inform written consent. A total of 16 patients (9 females, 7 males; mean age 52.6, range 20 - 82) underwent EUS drainage with SEMS. There were 14 cases of pseudocysts and 2 cases of walled-off necrosis. The etiologies of the PFC were mainly gallstones (8 of 16 patients, 50 %) and alcohol (5 of 16 patients, 31 %). Technical success was achieved in 100 % of the cases. All patients had a complete resolution of the PFC. Transmural EUS-guided drainage of complex PFC using SEMS is feasible, appears safe, and is efficacious. However, the exchange of the UC (uncovered)-SEMS for plastic stents is mandatory within 1 week. Future prospective studies, preferably multicenter studies, comparing SEMS versus traditional plastic stents for the drainage of PFC are warranted.

Intracoronary beta-radiation for the treatment of patients at very high risk for recurrence of in-stent restenosis: a single center experience.

PubMed

Parenti, Dennis Zavalloni; Marsico, Federica; Tosi, Giovanni; Catalano, Gianpiero; Maiello, Luigi; Milone, Francesco; Carcagnì, Addolorata; Pron, Paolo Giay; Orecchia, Roberto; Presbitero, Patrizia

2003-03-01

Intracoronary brachytherapy has significantly reduced the recurrence of in-stent restenosis. The aim of this study was to evaluate the feasibility, safety and efficacy of intracoronary beta-radiation in patients at very high risk for recurrence of in-stent restenosis. We analyzed 42 patients with 50 lesions submitted to catheter-based beta-radiation (Beta-Cath System, Novoste Corporation, Norcross, GA, USA) for in-stent restenosis. Thirty-eight lesions were at the second restenosis, 8 at the third, and 4 at the fourth; a diffuse pattern was present in 78%. Balloon angioplasty was performed for 30 lesions (60%) and the cutting balloon technique for 20 (40%). In 12 lesions further 14 stents had to be deployed (28%). The delivery catheter was successfully positioned in 96% of the procedures. The mean dwell time was 179 +/- 50 s with a radiation dose ranging from 18.4 to 25.3 Gy, depending on the vessel size. A complete angiographic success without coronary dissection and without any additional stenting after radiation delivery was achieved in 86%. At follow-up (7.2 +/- 2.1 months), the overall restenosis rate was 30.4% (14 lesions). A recurrence was detected in 1/11 lesions with initial focal pattern and in 13/39 lesions with initial diffuse pattern. The restenosis rate was higher in patients in whom a geographic miss had occurred (p < 0.05 vs lesions without geographic miss) and in those in whom a new stent had been deployed (p < 0.05 vs lesions treated without a stent). Brachytherapy reduces the in-stent restenosis rate in patients who are at very high risk of recurrence. The restenosis pattern, geographic miss and new stent deployment seem to be negative prognostic factors for recurrence of restenosis.

Expandable metallic stents for tracheobronchial stenoses in esophageal cancer.

PubMed

Takamori, S; Fujita, H; Hayashi, A; Tayama, K; Mitsuoka, M; Ohtsuka, S; Shirouzu, K

1996-09-01

Tracheobronchial stenosis in patients with esophageal cancer can be life threatening. Few reports have discussed use of expandable metallic stents for central airway stenoses in patients with esophageal cancer. Twelve patients with esophageal cancer underwent placement of expandable metallic stents for respiratory distress caused by tracheobronchial stricture. Single or double metallic stents were placed in the stenotic airways under fluoroscopic guidance. Improvement in respiratory symptoms and clinical outcome were assessed. Most stenoses were located in the trachea or the left main bronchus. From one to four expandable metallic stents were placed in each stricture site, with immediate relief of respiratory symptoms in 8 patients. One patient with tracheomalacia in alive 3 years after stent placement and another is alive 6 months after stent insertion. The other 10 patients lived from 10 to 70 days (mean; survival, 35 days) after stent placement. Death was due to progression of disease. Although metallic stents are useful for relieving respiratory distress in patients with advanced esophageal cancer, additional therapies should be considered.

76 FR 56200 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-12

... Stent. The ZILVER-PTX Stent is a self-expanding nitinol stent coated on its outer surface with the... millimeter. The ZILVER-PTX Stent is available in diameters ranging from 5 to 10 millimeters (mm) and lengths... deployment, the ZILVER-PTX Stent expands to establish and maintain patency in the stented region. The...

[The bioresorbable coronary stent: a revolution].

PubMed

Koegler, Flora; De Benedetti, Edoardo

2013-04-10

Coronary angioplasty has undergone several technological revolutions: starting with balloon angioplasty, then with bare metal stent and finally with drug eluting stent (DES), this technique is now mature. However, once we thought the problem of instent restenosis solved with DES, new concerns arise with late and very late stent thrombosis. Should we therefore proscribe DES? How long should be the duration of dual antiplatelet therapy? And how should we manage the patients who need a surgery and are at high risk of bleeding? Are bioresorbable stents the final solution with their initial mechanical properties, then with their drug eluting effect against intra-stent restenosis, and finally with their complete resorption which leaves the artery free of any foreign material?

Benchtop quantification of gutter formation and compression of chimney stent grafts in relation to renal flow in chimney endovascular aneurysm repair and endovascular aneurysm sealing configurations.

PubMed

Boersen, Johannes T; Donselaar, Esme J; Groot Jebbink, Erik; Starreveld, Roeliene; Overeem, Simon P; Slump, Cornelis H; de Vries, Jean-Paul P M; Reijnen, Michel M P J

2017-11-01

The chimney technique has been successfully used to treat juxtarenal aortic aneurysms. The two main issues with this technique are gutter formation and chimney graft (CG) compression, which induce a risk for type Ia endoleaks and stent thrombosis, respectively. In this benchtop study, the geometry and renal artery flow of chimney endovascular aneurysm repair configurations were compared with chimney configurations with endovascular aneurysm sealing (ch-EVAS). Seven flow phantoms were constructed, including one control and six chimney endovascular aneurysm repairs (Endurant [Medtronic Inc, Minneapolis, Minn] and AFX [Endologix Inc, Irvine, Calif]) or ch-EVAS (Nellix, Endologix) configurations, combined with either balloon-expandable or self-expanding CGs with an intended higher positioning of the right CG in comparison to the left CG. Geometric analysis was based on measurements at three-dimensional computed tomography angiography and included gutter volume and CG compression, quantified by the ratio between maximal and minimal diameter (D-ratio). In addition, renal artery flow was studied in a physiologic flow model and compared with the control. The average gutter volume was 343.5 ± 142.0 mm 3 , with the lowest gutter volume in the EVAS-Viabahn (W. L. Gore & Associates, Flagstaff, Ariz) combination (102.6 mm 3 ) and the largest in the AFX-Advanta V12 (Atrium Medical Corporation, Hudson, NH) configuration (559.6 mm 3 ). The maximum D-ratio was larger in self-expanding CGs than in balloon-expandable CGs in all configurations (2.02 ± 0.34 vs 1.39 ± 0.13). The CG compression had minimal influence on renal volumetric flow (right, 390.7 ± 29.4 mL/min vs 455.1 mL/min; left, 423.9 ± 28.3 mL/min vs 410.0 mL/min in the control). This study showed that gutter volume was lowest in ch-EVAS in combination with a Viabahn CG. CG compression was lower in configurations with the Advanta V12 than with Viabahn. Renal flow is unrestricted by CG compression. Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

A prospective group sequential study evaluating a new type of fully covered self-expandable metal stent for the treatment of benign biliary strictures (with video).

PubMed

Poley, Jan-Werner; Cahen, Djuna L; Metselaar, Herold J; van Buuren, Henk R; Kazemier, Geert; van Eijck, Casper H J; Haringsma, Jelle; Kuipers, Ernst J; Bruno, Marco J

2012-04-01

Fully-covered self expandable metal stents (fcSEMSs) are an alternative to progressive plastic stenting for the treatment of benign biliary strictures (BBS) with the prospect of a higher treatment efficacy and the need for fewer ERCPs, thereby reducing the burden for patients and possibly costs. Key to this novel treatment is safe stent removal. To investigate the feasibility and safety of stent removal of a fcSEMS with a proximal retrieval lasso: a long wire thread integrated in the proximal ends of the wire mesh that hangs freely in the stent lumen. Pulling it enables gradual removal of the stent inside-out. A secondary aim was success of stricture resolution. Non-randomized, prospective follow-up study with 3 sequential cohorts of 8 patients with BBS. Academic tertiary referral center. Eligible patients had strictures either postsurgical (post-cholecystectomy (LCx) or liver transplantation (OLT)), due to chronic pancreatitis (CP), or papillary stenosis (PF). Strictures had to be located at least 2 cm below the liver hilum. All patients had one plastic stent in situ across the stricture and had not undergone previous treatment with either multiple plastic stents or fcSEMS. The first cohort of patients underwent stent placement for 2 months, followed by 3 months if the stricture had not resolved. The second and third cohort started with 3 months and 4 months, respectively, both followed by another 4 months if indicated. Treatment success was defined by stricture resolution at cholangiography, the ability to pass an inflated extraction balloon and clinical follow-up (at least 6 months). safety of stent removal. Secondary outcomes were complications and successful stricture resolution. A total of 23 patients (11 female; 20-67 yrs) were eligible for final analysis. One patient developed a malignant neuroendocrine tumor in the setting of CP. Strictures were caused by CP (13), OLT (6), LCx (3) and PF (1). In total 39 fcSEMS were placed and removed. Removals were easy and without complications. Transient pain after insertion was common (13 of 23/56%) but was easily managed by analgesics in all patients. Other complications were cholecystitis (1), cholangitis due to stent migration (1, stent replaced) or stent clogging (2, managed endoscopically) and worsening of CP (2). In these patients, the fcSEMS was removed and replaced after pancreatic sphincterotomy and PD stent placement. Median follow-up was 15 months (range 11-25). Overall treatment success was 61% (14/23); in the CP group 46%, in the remaining patients 80% (p = 0.11). Patients with stricture resolution after removal of the first stent (n = 7; success 6/7) showed a trent towards a more sustained treatment success than patients who needed a 2nd stent placement (n = 16; success 8/16); p = 0.12). Small number of patients with regard to secondary outcomes. Removal of a new type of fcSEMS with a proximal retrieval lasso in patients with BBS proved easy and uncomplicated. Treatment success for CP strictures was higher compared to what is known from results of progressive plastic stenting protocols. For other indications treatment success was comparable to progressive plastic stenting, but with the prospect of fewer ERCP procedures. Copyright © 2012 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

Percutaneous Injection of Lidocaine Within the Carotid Body Area in Carotid Artery Stenting: An 'Old-New' Technique

DOE Office of Scientific and Technical Information (OSTI.GOV)

Mourikis, Dimitrios; Chatoupis, Konstantinos, E-mail: kchatoupis@yahoo.g; Katsenis, Konstantinos

2008-07-15

Severe bradycardia is a common untoward effect during balloon angioplasty when performing carotid artery stenting. Therefore atropine injection even before dilatation and the presence of an anesthesiologist are advocated in all patients. In the surgical literature, injection of a local anesthetic agent into the carotid sinus before carotid endarterectomy was performed in an attempt to ameliorate perioperative hemodynamic instability. This study was undertaken to test the hypothesis that percutaneous infiltration of the carotid sinus with local anesthetic immediately before balloon dilatation reduces bradycardia and ameliorates the need for atropine injection or the presence of an anesthesiologist. Infiltration of the carotidmore » sinus with 5 ml of 1% lidocaine, 3 min before dilatation, was performed in 30 consecutive patients. No one exhibited any significant rhythm change that required atropine injection. The anesthesiologist did not face any hemodynamic instability during the carotid artery stenting procedure.« less

Development of a dynamic in vitro model of a stented blood vessel to evaluate the effects of stent strut material selection and surface coating on smooth muscle cell response

NASA Astrophysics Data System (ADS)

Winn, Bradley Huegh

Cardiovascular disease is the leading cause of mortality in The United States and Europe, accounting for approximately half of all deaths. The most common form of cardiovascular disease is atherosclerosis, which is characterized by the formation of fatty atheromatous plaques that can grow to occlude the vessel lumen, thus causing ischemia distal to the occlusion. This is commonly treated using balloon angioplasty, which is usually done in conjunction with the deployment of a stent. Stent deployment helps hold the vessel open following the local injury caused by balloon inflation and prevents elastic recoil and subsequent negative remodeling. Stenting has been shown to significantly reduce restenosis rates from approximately 20-50% without a stent to about 10-30% with stent deployment. However, restenosis still remains the main cause of long-term stent failure. In basic terms, a balloon angioplasty procedure is a forceful displacement of an atherosclerotic lesion serving to widen the vessel lumen to increase blood flow. This procedure causes stretching of the vessel wall, tears in the atherosclerotic plaques, and general damage to the vessel in turn signaling a complex cascade of thrombosis, inflammation, intimal thickening, and vascular remodeling. Stent deployment also further complicates the immunological response by triggering a foreign body response from the implantation of a biomaterial into the body. When performing an angioplasty procedure, particularly in conjunction with stent deployment, a certain degree of vascular injury is inevitable. However, the initial injury can be further complicated by the body's local reaction to the implanted biomaterial, the severity of which can ultimately dictate the degree of restenosis and subsequently affect procedural success. The proliferative response of VSMCs to the various afore mentioned stimuli results in the formation of often copious amounts of neointimal tissue, generally known as intimal hyperplasia. The formation of this new tissue, primarily consisting of VSMCs of the synthetic phenotype and their subsequent extracellular matrix, is the sole causation of in-stent restenosis since the stent serves to prevent elastic recoil and negative remodeling. This doctoral research program is focused on endovascular stent biomaterials science and engineering. Overall, this doctoral project is founded on the hypothesis that smooth muscle cell hyperplasia, as an important causative factor for vascular restenosis following endovascular stent deployment, is triggered by the various effects of stent strut contact on the vessel wall including contact forces and material biocompatibility. In this program, a dynamic in vitro model of a stented blood vessel aimed at evaluating the effect of stent strut material selection, and surface coating on smooth muscle cell response was developed. The in vitro stented artery model was validated through the proliferation of VSMC in contact with stent struts. Additionally, it was demonstrated that, with respect to known biocompatible materials such as Nitinol and 316L stainless steel, DNA synthesis and alpha-actin expression, as indicators of VSMC phenotype, are independent of stent material composition. Furthermore, hydroxyapatite was shown to be a biocompatible stent surface coating with acceptable post-strain integrity. This coating was shown in a feasibility study to be capable of serving as a favorable drug delivery platform able to reliably deliver locally therapeutic doses of bisphosphonates, such as alendronate, to control VSMC proliferation in an in vitro model of a stented blood vessel. This stent coating/drug combination may be effective for reducing restenosis as a result of VSMC hyperplasia in vivo.

Initial Clinical Experience with an Endoluminal Spiral Prosthesis for Treating Complicated Venous Thrombosis and Preventing Pulmonary Embolism

PubMed Central

Jakob, H.; Oelert, H.; Schmiedt, W.; Teusch, P.; Iversen, S.; Hake, U.; Schild, H.; Maass, D.

1989-01-01

Fourteen patients with complicated venous thrombosis or recurrent pulmonary embolism were treated by implantation of an endoluminal spiral prosthesis subsequent to balloon angioplasty, surgical thrombectomy or embolectomy, a combination of these, or, in 2 cases, no other treatment. The patients were divided into 2 groups, based on their primary diagnosis and the purpose of the prosthesis. Group I included 8 patients with extensive iliofemoral or caval thrombosis, caused by congenital caval stenosis (1 case) or extravascular compression or retraction (7 cases); 7 of these patients had had previous operations, and the remaining patient had undergone thrombolysis, which failed. The current treatment consisted of balloon angioplasty and surgical thrombectomy or embolectomy, and implantation of an endoluminal spiral stent to prevent elastic recoil of the vessel. In 4 cases, an arteriovenous fistula was constructed and was taken down 3 months later; in 1 additional patient, a bilateral arteriovenous fistula was created. Group II comprised 6 patients with recurrent pulmonary embolism (4 cases), massive pulmonary embolism (1 case), or paradoxical bilateral carotid artery embolism (1 case). Four of these patients underwent surgical thrombectomy or embolectomy, while 2 had no treatment other than filter implantation. All 6 underwent transluminal implantation of a helix caval filter (a modification of the endoluminal spiral stent). All but 1 implantation was accomplished by means of either a transfemoral or a transjugular cutdown; the remaining implantation was performed transatrially after a pulmonary embolectomy. The only device-related complication was a retroperitoneal hematoma in Group I, resulting from perforation of the inferior vena cava by the guidewire during device implantation. This complication necessitated an emergency laparotomy and takedown of the arteriovenous fistula, which resulted in rethrombosis of the left iliofemoral vein. The other 7 stented veins were patent at early phlebographic follow-up, as were all 5 of those studied later. One Group-I patient died 4 months after surgery, due to tumor progression and without signs of caval restenosis. Twelve months postoperatively, 1 Group-II patient died of urosepsis without a recurrence of pulmonary embolism. Four of the 6 Group-II patients were studied late postoperatively, and all of their stented vessels were patent. There was no operative mortality or postoperative embolism. On the basis of these results, we conclude that endoluminal stenting with an expandable spiral prosthesis is a promising method for remote venous reconstruction. Moreover, it appears that the modified stent, or helix caval filter, compares favorably with commercially available filters. (Texas Heart Institute Journal 1989;16:87-94) Images PMID:15227219

Use of nitinol self-expandable stents in 26 dogs with tracheal collapse.

PubMed

Beranek, J; Jaresova, H; Rytz, U

2014-02-01

A study was designed to describe a novel approach to the treatment of tracheal collapse (TC) in dogs using self-expandable nitinol stents. Medical records were reviewed retrospectively for 26 client owned dogs in which nitinol stents were deployed. The entire length of trachea was supported independently of the extent of TC. Two overlapping stents were used instead of one in cases where one stent was not spanning the entire trachea adequately. The diameter of the cranial radiolucent portion of trachea, just behind the cricoid cartilage, was measured as a specific landmark to select the appropriate size of the stent. Two self-expandable nitinol stents were inserted in 9 of 26 dogs; the trachea in the rest of the cases was supported with only one stent. A follow up tracheoscopy was performed in 10 of 26 cases with recurrent clinical signs. Secondary tracheal stenosis in these cases was caused by stent fracture, granuloma or excessive stent shortening. Additional stents were placed successfully to expand the stenotic lumen. A support of the entire trachea may decrease risk of nitinol fracture at the end of the implant. Long term clinical improvement (25 of 26 dogs, 96 %) is comparable with the results of other studies.

Stents in Renal Artery Bifurcation Stenosis: A Case Report

PubMed Central

Leonardou, Polytimi; Pappas, Paris

2011-01-01

A 39-year-old patient presented with poorly controlled hypertension, and she was referred to renal angiogram and potential renal angioplasty. Renal angiogram showed a bifurcation lesion of the right renal artery. A guide wire was used to cross the upper branch, while the lower branch was protected by another same-type guide wire through the same introducer. Two thin monorail balloons were used to dilate the two branches; however, despite balloon dilatation, the stenosis of the vessels persisted. The “kissing balloon” technique was then attempted by simultaneously inflating both branches using the same balloons, but more than a 70% residual stenosis persisted in each branch. Two stents were finally placed in a “kissing” way through the main renal artery. The imaging and clinical results were good, without any procedure-related complications. Three years clinical followup was also good, without any reason for further interventional approach. PMID:21789043

Improvement of quality of life and survival using self-expandable metal stent placement for severe malignant stenosis of the gastric body: a case report.

PubMed

Kumagai, Hozumi; Nio, Kenta; Shirakawa, Tsuyoshi; Uchino, Keita; Kusaba, Hitoshi; Isobe, Taichi; Komoda, Masato; Tamura, Shingo; Maeyama, Ryo; Nagai, Eishi; Akashi, Koichi; Baba, Eishi

2012-09-19

Advanced gastric carcinoma often decreases quality of life because of upper gastrointestinal tract stenosis. Self-expandable metal stents have been thought to be an effective, minimally invasive treatment for stenosis. However, the effectiveness of self-expandable metal stent placement for carcinomatous stenosis of the gastric body and antrum has not been clarified, and there have been few reports of such cases. A 74-year-old Japanese woman developed stenosis of the gastric body and antrum caused by advanced gastric cancer during first-line chemotherapy. She developed weight loss and poor nutrition due to inadequate intake. Self-expandable metal stent placement for stenosis of the gastric body and antrum ameliorated her symptoms rapidly and improved her general condition and quality of life. Eight days after self-expandable metal stent placement, second-line chemotherapy could be administered safely. Oral intake and nutritional status were maintained for 117 days after self-expandable metal stent placement, and she died of gastric cancer 176 days after self-expandable metal stent placement and initiation of second-line chemotherapy. Self-expandable metal stent placement for carcinomatous stenosis in the gastric body and antrum could be an effective therapeutic strategy for patients with inadequate oral uptake. It may provide rapid improvement of the patient's general condition and oral intake with minimal complications, comparatively long-term symptom relief, and a survival benefit by allowing second-line chemotherapy.

Crimping and deployment of balloon-expandable valved stents are responsible for the increase in the hydraulic conductance of leaflets.

PubMed

Convelbo, Channing; Guetat, Pierre; Cambillau, Michèle; Allam, Bachir; Bruneval, Patrick; Lafont, Antoine; Zegdi, Rachid

2013-12-01

Leaflet injury has been documented to occur during the deployment of valved stents (VSs). The pathological aspects, however, of this injury are difficult to quantify. Conversely, the hydraulic conductance of a (pericardial) membrane may be easily determined. The impact of crimping and deployment of VS on this parameter was therefore investigated. Bovine pericardial square (25 × 25 mm) patches were placed within a pressure chamber and their hydraulic conductance was determined. The influence of the pressure gradient and tissue thickness on this parameter was analysed. Six balloon-expandable VS were constructed. The hydraulic conductance of their bovine pericardial leaflets was determined before and after VS crimping and deployment in four of them. Pericardial leaflets of non-crimped VS were used as controls. Hydraulic conductance increased insignificantly with the pressure level within the chamber: from 128 ± 26.9 ml/h/m(2)/mmHg at a pressure of 50 mmHg to 232.3 ± 51.9 ml/h/m(2)/mmHg at a pressure of 250 mmHg (P = 0.117). Hydraulic conductance was not correlated to pericardial thickness, for thickness measurements ranging from 0.34 to 0.76 mm. The hydraulic conductance of VS leaflets significantly increased immediately after crimping from 45.2 ± 7.6 to 667.9.0 ± 527.2 ml/h/m(2)/mmHg (P < 0.001). This increase was still observed 24 h after VS deployment. No change in hydraulic conductance occurred in the control group. The determination of the hydraulic conductance of pericardial patches was easy to perform, reproducible and not influenced by tissue thickness. The hydraulic conductance of pericardial leaflets dramatically increased after VS crimping and deployment. This parameter might be, in the future, a useful noninvasive tool in studying leaflet trauma.

Laser Atherectomy for Treatment of Femoropopliteal In-Stent Restenosis.

PubMed

Armstrong, Ehrin J; Thiruvoipati, Thejasvi; Tanganyika, Kundai; Singh, Gagan D; Laird, John R

2015-08-01

To investigate if laser atherectomy with adjunctive balloon angioplasty can improve endovascular treatment outcomes for femoropopliteal in-stent restenosis (ISR). A dual center study included 135 symptomatic patients (mean age 71 years; 76 men) who underwent endovascular treatment of femoropopliteal ISR between 2006 and 2013. Of these, 54 (40%) were treated with laser atherectomy and the remaining 81 patients with balloon angioplasty alone. Angiographic images were reviewed for lesion morphology and characteristics, TransAtlantic InterSociety Consensus (TASC) II classification, and distal runoff. Class I ISR was defined as focal lesions ≤50 mm, class II ISR as lesions >50 mm, and class III ISR as stent total occlusion. Recurrent ISR was determined by a peak systolic velocity ratio >2.4 by duplex ultrasound. Patients treated with laser atherectomy had longer mean ISR lesion length (222 vs 114 mm, p<0.001) and more class III ISR (69% vs 20%, p=0.001). There was no association between laser atherectomy and rates of recurrent restenosis or occlusion for patients with class I/II ISR, but there was a significantly lower rate of target lesion revascularization at 2 years among patients treated with laser atherectomy (14% vs 44%, p=0.05). In comparison, patients with class III ISR treated with laser atherectomy had lower rates of recurrent restenosis at 1 year (54% vs 91%, p=0.05) and 2 years (69% vs 100%, p=0.05). Patients with class III ISR treated with laser atherectomy also had lower rates of recurrent in-stent occlusion at 2-year follow-up (33% vs 71%, p=0.04). When used to treat complex ISR, including in-stent occlusions, laser atherectomy with adjunctive balloon angioplasty may be associated with improved patency. © The Author(s) 2015.

Transcatheter Pulmonary Valve Replacement by Hybrid Approach Using a Novel Polymeric Prosthetic Heart Valve: Proof of Concept in Sheep

PubMed Central

Xu, Tong-yi; Zhang, Zhi-gang; Li, Xin; Han, Lin; Xu, Zhi-yun

2014-01-01

Background Since 2000, transcatheter pulmonary valve replacement has steadily advanced. However, the available prosthetic valves are restricted to bioprosthesis which have defects like poor durability. Polymeric heart valve is thought as a promising alternative to bioprosthesis. In this study, we introduced a novel polymeric transcatheter pulmonary valve and evaluated its feasibility and safety in sheep by a hybrid approach. Methods We designed a novel polymeric trileaflet transcatheter pulmonary valve with a balloon-expandable stent, and the valve leaflets were made of 0.1-mm expanded polytetrafluoroethylene (ePTFE) coated with phosphorylcholine. We chose glutaraldehyde-treated bovine pericardium valves as control. Pulmonary valve stents were implanted in situ by a hybrid transapical approach in 10 healthy sheep (8 for polymeric valve and 2 for bovine pericardium valve), weighing an average of 22.5±2.0 kg. Angiography and cardiac catheter examination were performed after implantation to assess immediate valvular functionality. After 4-week follow-up, angiography, echocardiography, computed tomography, and cardiac catheter examination were used to assess early valvular function. One randomly selected sheep with polymeric valve was euthanized and the explanted valved stent was analyzed macroscopically and microscopically. Findings Implantation was successful in 9 sheep. Angiography at implantation showed all 9 prosthetic valves demonstrated orthotopic position and normal functionality. All 9 sheep survived at 4-week follow-up. Four-week follow-up revealed no evidence of valve stent dislocation or deformation and normal valvular and cardiac functionality. The cardiac catheter examination showed the peak-peak transvalvular pressure gradient of the polymeric valves was 11.9±5.0 mmHg, while that of two bovine pericardium valves were 11 and 17 mmHg. Gross morphology demonstrated good opening and closure characteristics. No thrombus or calcification was seen macroscopically. Conclusions This design of the novel ePTFE transcatheter pulmonary valve is safe and effective to deploy in sheep by hybrid approach, and the early valvular functionality is good. PMID:24926892

Double balloon protection during carotid artery stenting for vulnerable carotid stenosis reduces the incidence of new brain lesions.

PubMed

Nakazaki, Masahito; Nonaka, Tadashi; Takahashi, Akira; Yonemasu, Yasuyuki; Nomura, Tatsufumi; Onda, Toshiyuki; Honda, Osamu; Hashimoto, Yuji; Ohnishi, Hirofumi; Sasaki, Masanori; Daibo, Masahiko; Honmou, Osamu

2016-07-01

The use of distal filter protection alone is associated with a high risk of ischemic complications when vulnerable carotid stenosis is treated by carotid artery stenting (CAS). Double balloon protection, a combination of distal balloon protection and proximal balloon occlusion, can be utilized. We assessed the outcome and complications of the double balloon protection method for vulnerable carotid stenosis. Among 130 patients who underwent CAS from 2009 to 2014, we enrolled the following patients: those whose target lesion was vulnerable as evaluated by MRI, i.e., a signal ratio of plaque to posterior cervical muscle on T1-weighted images before CAS of ≥1.5, and those who underwent diffusion-weighted imaging (DWI) studies within 48 h after the procedure. Ninety patients were enrolled. We investigated DWI findings of the double balloon protection group compared with those of the simple distal balloon protection and distal filter protection groups. Sixty-four patients (71 %) underwent double balloon protection, 15 patients (17 %) simple distal balloon protection, and 11 patients (12 %) distal filter protection. Symptomatic embolic complications and new lesions on DWI after CAS were significantly less common in patients undergoing double balloon protection compared to distal balloon protection or distal filter protection (0 % vs. 20 %, 9 %, P < 0.01, and 30 % vs. 67 %, 82 %, P < 0.01, respectively). Logistic regression analysis also identified the odds ratio of double balloon protection for new lesions on DWI after CAS of 0.23 (95 % confidence interval: 0.07-0.70, P < 0.01) compared to simple distal protections. In the patients who underwent CAS for vulnerable carotid stenosis, double balloon protection was an independent significant factor associated with a reduction in the risk of new lesions on DWI after the procedure compared to conventional distal protections.

Tracheal obstruction caused by an expandable metallic stent: a case of successful removal of the stent.

PubMed

Okuyama, Hiroomi; Kubota, Akio; Kawahara, Hisayoshi; Oue, Takaharu; Nose, Satoko; Ihara, Toshiyuki

2005-07-01

We report a case of tracheal obstruction caused by an expandable metallic stent. A 3-month-old girl with severe tracheomalacia had a placement of a Palmaz stent. At 3 years of age, she developed progressive dyspnea. The CT scan showed tracheal obstruction caused by granulation tissue over the stent. At operation, the stent was found to have penetrated the posterior tracheal wall. Under partial cardiopulmonary bypass, the stent was removed along with the membranous wall of the trachea, and the trachea was reconstructed using slide tracheoplasty. Tracheal obstruction is one of the serious complications caused by an expandable metallic stent. Direct open approach to the trachea under cardiopulmonary bypass is thought to be a safe way to manage this problem.

Intervention Therapy for Portal Vein Stenosis/Occlusion After Pediatric Liver Transplantation.

PubMed

Gao, Haijun; Wang, Hao; Chen, Guang; Yi, Zhengjia

2017-04-18

BACKGROUND The aim of this study was to investigate the outcomes and stent implantation timing of portal vein stenosis intervention after pediatric liver transplantation (pLT). MATERIAL AND METHODS The clinical data of 30 children with post-liver transplantation portal vein stenosis/occlusion (PVS/O) between Jan 2008 and Jun 2015 were retrospectively analyzed. The successfully re-opened cases used balloon angioplasty or stent implantation. SPSS13.0 software was used for statistical analysis and paired t test of the pressure gradient at both ends of the stenosis, diameter and flow rate within the stenosis, platelet count, and albumin in the PVS children before and after balloon angioplasty, with p<0.05 considered as statistically significant. Among the 30 patients, 6 received a stent implant in their first treatment, 22 received balloon angioplasty in their first treatment, and in 2 the re-opening could not be achieved. RESULTS The diameter of the stenotic segment, portal vein velocity, pressure gradient at both ends of the stenosis, and platelet count in these children with portal vein stenosis/occlusion (PVS/O) showed statistically significant differences when comparing values before and after intervention (p<0.05), but albumin showed no statistically significant difference (p>0.05). CONCLUSIONS Intervention therapy for portal vein stenosis after pediatric liver transplantation (pLT-PVS) is a safe and effective treatment, and patients with portal vein torsion, intimal tearing, or long portal vein segment occlusion should undergo stent implantation.

Results From the VISIBILITY Iliac Study: Primary and Cohort Outcomes at 9 Months.

PubMed

Rundback, John H; Peeters, Patrick; George, Jon C; Jaff, Michael R; Faries, Peter L

2017-06-01

To evaluate the safety and effectiveness of primary stenting of the common (CIA) or external iliac artery (EIA) using the Visi-Pro Balloon-Expandable Peripheral Stent System for treatment of stenotic, restenotic, or occluded lesions. Between 2011 and 2012, 75 patients (mean age 64.2±8.9 years; 46 men) with Rutherford category 2-4 ischemia and atherosclerotic lesions ≤10 cm in length underwent iliac artery stenting at 17 centers in the United States and Europe. The primary outcome of the study was the major adverse event (MAE) rate at 9 months postprocedure [composite of periprocedural death, in-hospital myocardial infarction, clinically driven target lesion revascularization (CD-TLR), and amputation of the treated limb]. Secondary outcomes included 30-day MAE rate, 9-month primary patency, changes in ankle-brachial index (ABI) and the Walking Impairment Questionnaire at 30 days and 9 months postprocedure, device success, and clinically driven target vessel revascularization (CD-TVR) at 30 days and 9 months. Outcomes in specific patient cohorts (ie, gender, stent location, calcification severity, and lesion grade) were analyzed. Eighty-one stents were implanted in 61 CIA and 15 EIA lesions (41 with moderate/severe calcification). The mean lesion treated length was 29.3±13.9 mm. All devices were successfully deployed. MAE occurred in 3 (4.0%) of 75 subjects at 9 months. Primary patency and freedom from CD-TVR at 9 months were both 95.8%. ABI improved from 0.67±0.14 at baseline to 0.94±0.14 and 0.96±0.16 at 30 days and 9-month follow-up, respectively (p<0.001 for both). There were no differences with respect to any of the analyzed patient characteristics, including gender. Nine-month results of the VISIBILITY Iliac stent study ( ClinicalTrials.gov identifier NCT01402700) demonstrated safety and effectiveness for the treatment of atherosclerotic CIA and EIA lesions with the Visi-Pro stent across all treated cohorts.

Treatment of cuff-related tracheal stenosis with a fully covered retrievable expandable metallic stent.

PubMed

Chen, G; Wang, Z; Liang, X; Wang, Y; Wang, Y; Wang, Z; Xian, J

2013-04-01

To investigate the clinical effectiveness, complications, and optimal duration of use of covered retrievable expandable metallic stents in the management of cuff-related tracheal stenosis. Twenty-one patients with cuff-related tracheal stenosis, Meyer-Cotton grade II (29%) and III (71%), who underwent fluoroscopically guided placement of covered retrievable expandable metallic stents were studied. Sixty-four-section computed tomography (CT) and bronchovideoscopy were performed prior to stent insertion, 1 month after stent insertion, in the case of stent-related complications, and after stent removal. Clinical manifestations, Hugh-Jones classification, and forced expiratory volume in 1 s (FEV1) were used to evaluate respiratory function before and after stent insertion and removal. The diameter of the stricture and FEV1 changes before insertion and after removal were analysed using the paired samples t-test. A p-value of ≤0.05 was considered statistically significant. Twenty-one patients had 27 covered retrievable expandable metallic stents placed. Stents were electively removed from 20 patients. The median duration of stent placement was 5 months (range 4-12 months). One stent was not removed due to mucopolysaccharidosis type II (MPS II or Hunter syndrome) with tracheomalacia. After stent removal, airway dimensions increased and airway occlusion was symptomatically relieved in all patients. CT and bronchovideoscopy showed patent lumens with increased dimensions. Stent-related complications occurred in 19 (91%) patients, including granulation tissue formation (n = 18, 86%), stent migration and stent expectoration (n = 2, 10%), mucus plugging (n = 1, 5%), and halitosis (n = 6, 29%). Some patients experienced multiple complications, which were all managed effectively while the stent was still in place. There was a statistically significant difference in the diameter of the stricture and FEV1 between the time of stent insertion and removal. An improvement in Hugh-Jones classification of greater than one grade was seen in patients after stent removal. Temporary placement of a fully covered retrievable expandable metallic stent is safe and effective in cuff-related tracheal stenosis. The optimal duration of stent placement may be 4-8 months. Copyright © 2012 The Royal College of Radiologists. Published by Elsevier Ltd. All rights reserved.

Tracheal stricture and fistula: management with a barbed silicone-covered retrievable expandable nitinol stent.

PubMed

Kim, Yong Hee; Shin, Ji Hoon; Song, Ho-Young; Kim, Jin Hyoung

2010-02-01

The purpose of this study was to evaluate the safety and effectiveness of a barbed silicone-covered retrievable expandable nitinol stent in preventing stent migration in patients with tracheal strictures or fistulas. Under fluoroscopic guidance, barbed silicone-covered retrievable expandable nitinol stents were placed in 15 patients with tracheal strictures, two patients with fistulas, two patients with combined strictures and fistulas, and one patient with variable extrathoracic airway obstruction. The three pairs of barbs were attached to the external stent surface at the middle of the stent at equal intervals. Technical success, improvement in respiratory status, complications, and related interventions were evaluated. The technical success rate was 100%, and respiratory status improved or the fistula closed in all 20 patients. Complications included sputum retention (three patients), tumor overgrowth (three patients), pain (one patient), and granulation tissue formation (one patient). No stent migration occurred, even in the three patients without fixed strictures. Four stents subsequently were removed because of complications, and one stent was removed because the patient's condition improved. Stent removal was not difficult and was uneventful. The silicone membranes and barbs of the removed stents were intact. Use of a barbed silicone-covered retrievable expandable nitinol stent relieves dyspnea and facilitates fistula closure in patients with benign or malignant tracheal strictures or fistulas. The barbed design of the stent is important in preventing migration.

The Safety and efficacy of a new self-expandable intratracheal nitinol stent for the tracheal collapse in dogs

PubMed Central

Kim, Joon-young; Han, Hyun-jung; Yun, Hun-young; Lee, Bora; Jang, Ha-young; Eom, Ki-dong; Park, Hee-myung

2008-01-01

To evaluate the potential utility of a self-expandable intratracheal nitinol stent with flared ends for the treatment of tracheal collapse in dogs, endotracheal stenting therapy was performed under fluoroscopic guidance in four dogs with severe tracheal collapse. During the 4 to 7 month follow-up, after stent implantation, clinical signs, including dyspnea and respiratory distress, dramatically improved in all dogs. The radiographs showed that the implanted stents improved the tracheal collapse, and there were no side effects such as collapse, shortening or migration of the stents. In conclusion, the self-expandable intratracheal nitinol stents provided adequate stability to the trachea and were effective for attenuating the clinical signs associated with severe tracheal collapse. PMID:18296893

Novel paclitaxel-coated angioplasty balloon catheter based on cetylpyridinium salicylate: preparation, characterization and simulated use in an in vitro vessel model.

PubMed

Petersen, Svea; Kaule, Sebastian; Stein, Florian; Minrath, Ingo; Schmitz, Klaus-Peter; Kragl, Udo; Sternberg, Katrin

2013-10-01

Drug-coated balloons (DCB), which have emerged as therapeutic alternative to drug-eluting stents in percutaneous cardiovascular intervention, are well described with regard to clinical efficiency and safety within a number of clinical studies. In vitro studies elucidating the correlation of coating method and composition with DCB performance are however rare but considered important for the understanding of DCB requirements and the improvement of established DCB. In this context, we evaluated the applicability of a pipetting, dip-coating, and spray-coating process for the establishment of DCB based on paclitaxel (PTX) and the ionic liquid cetylpyridinium salicylate (Cetpyrsal) as novel innovative additive in three different compositions. Among tested methods and compositions, the pipetting process with 50 wt.% PTX resulted in most promising coatings as drug load was less controllable by the other processes and higher PTX contents led to considerable drug crystallization, as visualized by electron microscopy, accelerating PTX loss during short-term elution. Applying these conditions, homogeneous coatings could be applied on balloon catheter, whose simulated use in an in vitro vessel model revealed percental drug losses of 36 and 28% during transit and percental drug transfers of 12 and 40% under expansion for coatings applied in expanded and folded balloon condition, respectively. In comparison to literature values, these results support the high potential of Cetpyrsal as novel DCB matrix regarding low drug loss and efficient drug transfer. © 2013.

Comparison of expandable endotracheal stents in the treatment of surgically induced piglet tracheomalacia.

PubMed

Mair, E A; Parsons, D S; Lally, K P; Van Dellen, A F

1991-09-01

Present surgical alternatives for pediatric tracheobronchomalacia are limited and associated with many potentially undesirable complications. The feasibility of different intraluminal expandable endotracheal stents for the treatment of surgically induced tracheomalacia was analyzed in 27 piglets. A potentially fatal tracheomalacia was surgically created. Either a stainless steel "zig-zag" stent or a woven polymeric stent was then implanted. Tracheal patency, mucosal function, histopathologic respiratory tract changes, and effects of the stent on esophageal motility were evaluated over a 16-week period. Piglets with steel stents uniformly experienced intense inflammation leading to tracheal dysfunction and death. Piglets with polymeric stents experienced minimal respiratory symptoms. Expandable polymeric endotracheal stents alleviate surgically induced piglet tracheomalacia, were easy to insert, allowed for tracheal growth, and reduced the need for high-risk surgical procedures with prolonged ventilatory support.

[Evaluation of stents in treating childhood benign esophageal strictures].

PubMed

Reinshagen, K; Kähler, G; Manegold, B C; Waag, K-L

2009-01-01

Esophageal stenting is a popular of treatment of esophageal strictures in adults. It has also been described for children with benign strictures who did not respond to standard dilatation therapy. The aim of the study was to evaluate weather esophageal stents could be used safely and effectively in the treatment of benign esophageal strictures in children. From 1993 to 2005 stenting therapy was performed in 12 children with complicated esophageal strictures. Etiologies of the strictures were caustic burns in 9 patients, postoperative strictures due to complicated esophageal atresia in 2 patients and iatrogenic esophageal injury in 1 patient. Esophageal silicon tubi, covered retrievable expandable nitinol and plastic stents were placed endoscopically. The clinical course and the long term follow up were evaluated retrospectively The stents and tubi were placed in all patients without complications and were later removed successfully. 6 patients were treated with a self expanding plastic stent. The plastic stents showed a distinct tendency to migrate but in 5/6 patients esophageal stricture was treated successfully. 3 patients were treated by a covered self expanding nitinol stent. No migration occurred. One patient was asymptomatic after therapy, one required further dilatation therapy and the third had esophageal resection. 3 patients were treated by esophageal tubi. 2 patients required surgery in the follow up, one patient is asymptomatic. The use of stenting devices in children to treat benign esophageal strictures is safe and efficient. The self expanding plastic stents had the best long term results but required high compliance of parents and children due to the tendency of stent migration. Self expanding nitinol stents are more traumatic at the extraction procedure and are useful in patients with low compliance. Recurrence of strictures occurred most often after esophageal tubi possibly due to the lack of radial expansion.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lanciego, Carlos; Rodriguez, Mario; Rodriguez, Adela

The use of metallic stents in the management of benign and malignant superior vena cava syndrome (SVCS) is well documented. Symptomatic stenosis or occlusion of the SVC is a rare complication of a transvenous permanent pacemaker implant. Suggested treatments have included anticoagulation therapy, thrombolysis, balloon angioplasty and surgery. More recently, endovascular stenting has evolved as an attractive alternative but the data available in the literature are limited. We describe a case in which venous stenting with a Wallstent endoprosthesis was used successfully. The patient remains symptom free and with normal pacemaker function 36 months later.

In vivo delivery and long-term tissue retention of nano-encapsulated sirolimus using a novel porous balloon angioplasty system.

PubMed

Granada, Juan F; Tellez, Armando; Baumbach, William R; Bingham, Brendan; Keng, Yen-Fang; Wessler, Jeffrey; Conditt, Gerard; McGregor, Jennifer; Stone, Gregg; Kaluza, Greg L; Leon, Martin B

2016-08-20

Among antirestenotic compounds, sirolimus displays a superior safety profile compared to paclitaxel, but its pharmacokinetic properties make it a challenging therapeutic candidate for single-time delivery. Herein we evaluate the feasibility of delivery, long-term retention and vascular effects of sirolimus nanoparticles delivered through a novel porous angioplasty balloon in normal porcine arteries and in a swine model of in-stent restenosis (ISR). Sirolimus nanoparticle formulation was delivered via porous balloon angioplasty to 753 coronary artery segments for pharmacokinetic studies and 26 segments for biological effect of sirolimus delivery in different clinical scenarios (de novo [n=8], ISR [n=6] and following stent implantation [n=12]). Sirolimus coronary artery concentrations were above the target therapeutic level of 1 ng/mg after 26 days, and were >100-fold higher in coronary artery treatment sites than in distal myocardium and remote tissues at all time points. At 28 days, reduction in percent stenosis in formulation-treated sites compared to balloon angioplasty treatment was noted in all three clinical scenarios, with the largest effect seen in the de novo study. Local coronary delivery of sirolimus nanoparticles in the porcine model using a novel porous balloon delivery system achieved therapeutic long-term intra-arterial drug levels without significant systemic residual exposure.

A prospective, multi-center study of the chocolate balloon in femoropopliteal peripheral artery disease: The Chocolate BAR registry.

PubMed

Mustapha, Jihad A; Lansky, Alexandra; Shishehbor, Mehdi; Miles McClure, John; Johnson, Sarah; Davis, Thomas; Makam, Prakash; Crowder, William; Konstantino, Eitan; Attaran, Robert R

2018-05-01

The Chocolate BAR study is a prospective multicenter post-market registry designed to evaluate the safety and performance of the Chocolate percutaneous transluminal angioplasty balloon catheter in a broad population with symptomatic peripheral arterial disease. The primary endpoint is acute procedural success (defined as ≤30% residual stenosis without flow-limiting dissection); secondary long-term outcomes include freedom from target lesion revascularization (TLR), major unplanned amputation, survival, and patency. A total of 262 patients (290 femoropopliteal lesions) were enrolled at 30 US centers between 2012 and 2014. The primary endpoint of procedure success was achieved in 85.1% of cases, and freedom from stenting occurred in 93.1%. Bail out stenting by independent adjudication occurred in 1.6% of cases and there were no flow limiting dissections. There was mean improvement of 2.1 Rutherford classes (±1.5) at 12-months, with 78.5% freedom from TLR, 97.2% freedom from major amputation, and 93.3% freedom from all-cause mortality. Core Lab adjudicated patency was 64.1% at 12 months. Use of the Chocolate balloon in an "all-comers" population achieved excellent procedural outcomes with low dissection rates and bailout stent use. © 2018 Wiley Periodicals, Inc.

Balloon dilation of congenital supravalvular pulmonic stenosis in a dog.

PubMed

Treseder, Julia R; Jung, SeungWoo

2017-03-30

Percutaneous balloon valvuloplasty is considered the standard of care for treatment of valvular pulmonic stenosis, a common congenital defect in dogs. Supravalvular pulmonic stenosis is a rare form of pulmonic stenosis in dogs and standard treatment has not been established. Although, there have been reports of successful treatment of supravalvular pulmonic stenosis with surgical and stenting techniques, there have been no reports of balloon dilation to treat dogs with this condition. Here, a case of supravalvular pulmonic stenosis diagnosed echocardiographically and angiographically in which a significant reduction in pressure gradient was achieved with balloon dilation alone is presented.

Clinical outcomes of self-expandable stent placement for benign esophageal diseases: A pooled analysis of the literature

PubMed Central

van Halsema, Emo E; van Hooft, Jeanin E

2015-01-01

AIM: To analyze the outcomes of self-expandable stent placement for benign esophageal strictures and benign esophageal leaks in the literature. METHODS: The PubMed, Embase and Cochrane databases were searched for relevant articles published between January 2000 and July 2014. Eight prospective studies were identified that analyzed the outcomes of stent placement for refractory benign esophageal strictures. The outcomes of stent placement for benign esophageal leaks, perforations and fistulae were extracted from 20 retrospective studies that were published after the inclusion period of a recent systematic review. Data were pooled and analyzed using descriptive statistics. RESULTS: Fully covered self-expandable metal stents (FC SEMS) (n = 85), biodegradable (BD) stents (n = 77) and self-expandable plastic stents (SEPS) (n = 70) were inserted in 232 patients with refractory benign esophageal strictures. The overall clinical success rate was 24.2% and according to stent type 14.1% for FC SEMS, 32.9% for BD stents and 27.1% for SEPS. Stent migration occurred in 24.6% of cases. The overall complication rate was 31.0%, including major (17.7%) and minor (13.4%) complications. A total of 643 patients were treated with self-expandable stents mainly for postsurgical leaks (64.5%), iatrogenic perforations (19.6%), Boerhaave’s syndrome (7.8%) and fistulae (3.7%). FC SEMS and partially covered SEMS were used in the majority of patients. Successful closure of the defect was achieved in 76.8% of patients and according to etiology in 81.4% for postsurgical leaks, 86.0% for perforations and 64.7% for fistulae. The pooled stent migration rate was 16.5%. Stent-related complications occurred in 13.4% of patients, including major (7.8%) and minor (5.5%) complications. CONCLUSION: The outcomes of stent placement for refractory benign esophageal strictures were poor. However, randomized trials are needed to put this into perspective. The evidence on successful stent placement for benign esophageal leaks, perforations and fistulae is promising. PMID:25685270

Clinical outcomes of self-expandable stent placement for benign esophageal diseases: A pooled analysis of the literature.

PubMed

van Halsema, Emo E; van Hooft, Jeanin E

2015-02-16

To analyze the outcomes of self-expandable stent placement for benign esophageal strictures and benign esophageal leaks in the literature. The PubMed, Embase and Cochrane databases were searched for relevant articles published between January 2000 and July 2014. Eight prospective studies were identified that analyzed the outcomes of stent placement for refractory benign esophageal strictures. The outcomes of stent placement for benign esophageal leaks, perforations and fistulae were extracted from 20 retrospective studies that were published after the inclusion period of a recent systematic review. Data were pooled and analyzed using descriptive statistics. Fully covered self-expandable metal stents (FC SEMS) (n = 85), biodegradable (BD) stents (n = 77) and self-expandable plastic stents (SEPS) (n = 70) were inserted in 232 patients with refractory benign esophageal strictures. The overall clinical success rate was 24.2% and according to stent type 14.1% for FC SEMS, 32.9% for BD stents and 27.1% for SEPS. Stent migration occurred in 24.6% of cases. The overall complication rate was 31.0%, including major (17.7%) and minor (13.4%) complications. A total of 643 patients were treated with self-expandable stents mainly for postsurgical leaks (64.5%), iatrogenic perforations (19.6%), Boerhaave's syndrome (7.8%) and fistulae (3.7%). FC SEMS and partially covered SEMS were used in the majority of patients. Successful closure of the defect was achieved in 76.8% of patients and according to etiology in 81.4% for postsurgical leaks, 86.0% for perforations and 64.7% for fistulae. The pooled stent migration rate was 16.5%. Stent-related complications occurred in 13.4% of patients, including major (7.8%) and minor (5.5%) complications. The outcomes of stent placement for refractory benign esophageal strictures were poor. However, randomized trials are needed to put this into perspective. The evidence on successful stent placement for benign esophageal leaks, perforations and fistulae is promising.

Alteration of intraaneurysmal hemodynamics by placement of a self-expandable stent. Laboratory investigation.

PubMed

Tateshima, Satoshi; Tanishita, Kazuo; Hakata, Yasuhiro; Tanoue, Shin-ya; Viñuela, Fernando

2009-07-01

Development of a flexible self-expanding stent system and stent-assisted coiling technique facilitates endovascular treatment of wide-necked brain aneurysms. The hemodynamic effect of self-expandable stent placement across the neck of a brain aneurysm has not been well documented in patient-specific aneurysm models. Three patient-specific silicone aneurysm models based on clinical images were used in this study. Model 1 was constructed from a wide-necked internal carotid artery-ophthalmic artery aneurysm, and Models 2 and 3 were constructed from small wide-necked middle cerebral artery aneurysms. Neuroform stents were placed in the in vitro aneurysm models, and flow structures were compared before and after the stent placements. Flow velocity fields were acquired with particle imaging velocimetry. In Model 1, a clockwise, single-vortex flow pattern was observed in the aneurysm dome before stenting was performed. There were multiple vortices, and a very small fast flow stream was newly formed in the aneurysm dome after stenting. The mean intraaneurysmal flow velocity was reduced by approximately 23-40%. In Model 2, there was a clockwise vortex flow in the aneurysm dome and another small counterclockwise vortex in the tip of the aneurysm dome before stenting. The small vortex area disappeared after stenting, and the mean flow velocity in the aneurysm dome was reduced by 43-64%. In Model 3, a large, counterclockwise, single vortex was seen in the aneurysm dome before stenting. Multiple small vortices appeared in the aneurysm dome after stenting, and the mean flow velocity became slower by 22-51%. The flexible self-expandable stents significantly altered flow velocity and also flow structure in these aneurysms. Overall flow alterations by the stent appeared favorable for the long-term durability of aneurysm embolization. The possibility that the placement of a low-profile self-expandable stent might induce unfavorable flow patterns such as a fast flow stream in the aneurysm dome cannot be excluded.

Feasibility of using bulk metallic glass for self-expandable stent applications.

PubMed

Praveen Kumar, Gideon; Jafary-Zadeh, Mehdi; Tavakoli, Rouhollah; Cui, Fangsen

2017-10-01

Self-expandable stents are widely used to restore blood flow in a diseased artery segment by keeping the artery open after angioplasty. Despite the prevalent use of conventional crystalline metallic alloys, for example, nitinol, to construct self-expandable stents, new biomaterials such as bulk metallic glasses (BMGs) are being actively pursued to improve stent performance. Here, we conducted a series of analyses including finite element analysis and molecular dynamics simulations to investigate the feasibility of using a prototypical Zr-based BMG for self-expandable stent applications. We model stent crimping of several designs for different percutaneous applications. Our results indicate that BMG-based stents with diamond-shaped crowns suffer from severe localization of plastic deformation and abrupt failure during crimping. As a possible solution, we further illustrate that such abrupt failure could be avoided in BMG-based stents without diamond shape crowns. This work would open a new horizon for a quest toward exploiting superior mechanical and functional properties of metallic glasses to design future stents. © 2016 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 105B: 1874-1882, 2017. © 2016 Wiley Periodicals, Inc.

[Immediate and Long-term Results of the First in Russia of IntrocoronaryMetal Stent in the Coronary Artery].

PubMed

Babunashvili, A M; Navtsishvili, Z G; Konstantinov, B A

2016-02-01

The authors present immediate and long term results of the first in Russia implantation in coronary artery of Palmaz-Shatz metal stent. Indications for stenting were urgent after complicated dissection as a result of balloon dilation of discrete bifurcational stenosis of anterior interventricular artery (IVA). Immediate angiographic and clinical result was good. At control angiography after 13 years their was no restenosis in stented IVA. However novel narrowing was found in left main coronary artery (LMCA) in which drug eluting stent was implanted. Coronary angiography carried out after 7.5 years after stenting of LMCA and in 20 years after stent implantation in IVA revealed good patency of both stented segments without signs of restenosis. This case report demonstrates possibility of long term preservation of angiographic and clinical effect of staged endovascular treatment of coronary atherosclerosis.

Esophagojejunal Anastomosis Fistula, Distal Esophageal Stenosis, and Metalic Stent Migration after Total Gastrectomy

PubMed Central

Al Hajjar, Nadim; Popa, Calin; Al-Momani, Tareg; Margarit, Simona; Graur, Florin; Tantau, Marcel

2015-01-01

Esophagojejunal anastomosis fistula is the main complication after a total gastrectomy. To avoid a complex procedure on friable inflamed perianastomotic tissues, a coated self-expandable stent is mounted at the site of the anastomotic leak. A complication of stenting procedure is that it might lead to distal esophageal stenosis. However, another frequently encountered complication of stenting is stent migration, which is treated nonsurgically. When the migrated stent creates life threatening complications, surgical removal is indicated. We present a case of a 67-year-old male patient who was treated at our facility for a gastric adenocarcinoma which developed, postoperatively, an esophagojejunostomy fistula, a distal esophageal stenosis, and a metallic coated self-expandable stent migration. To our knowledge, this is the first reported case of an esophagojejunostomy fistula combined with a distal esophageal stenosis as well as with a metallic coated self-expandable stent migration. PMID:25945277

Drug eluting balloons for the treatment of coronary artery disease: What can we expect?

PubMed Central

Joost, Alexander; Kurowski, Volkhard; Radke, Peter W

2010-01-01

Drug-eluting balloons (DEBs) represent an enhancement of the therapeutic repertoire for the interventional cardiologist. The therapeutic concept of DEBs is promising, notably on the basis of initial studies in patients with diffuse in-stent restenosis (ISR). At present, however, a number of questions regarding long-term efficacy and safety remain, specifically in indications other than diffuse ISR. The results of the evaluation of different substances, balloon systems and clinical indications will determine the long-term success of DEBs. PMID:21160601

Novel use of cutting balloon to treat subintimal hematomas during chronic total occlusion interventions.

PubMed

Vo, Minh N; Brilakis, Emmanouil S; Grantham, J Aaron

2018-01-01

Contemporary chronic total occlusion (CTO) percutaneous coronary interventional (PCI) techniques are increasingly dependent upon dissection and reentry techniques (DARTs) especially for long occluded lesions. DARTs can result in compressive hematomas during CTO interventions and traditional treatment with balloon angioplasty and/or coronary stenting are often suboptimal and may extend the hematoma distally. We describe the novel use of a cutting balloon to "express" these compressive hematomas and restore antegrade coronary blood flow. © 2017 Wiley Periodicals, Inc.

Use of covered self-expandable stents for benign colorectal disorders in children.

PubMed

Lange, Bettina; Sold, Moritz; Kähler, Georg; Wessel, Lucas M; Kubiak, Rainer

2017-01-01

There is a lack of experience with covered self-expandable stents for benign colorectal disorders in children. Five children (4M, 1F) with a median age of 5years (range, 6months-9years) who underwent treatment with covered self-expandable plastic (SEPSs) or self-expandable metal stents (SEMSs) for a benign colorectal condition between April 2005 and November 2013 were recruited to this retrospective study. Etiologies included: anastomotic stricture with (n=1) or without (n=3) simultaneous enterocutaneous fistula, as well as an anastomotic leak associated with enterocutaneous fistula (n=1). All children suffered from either Hirschsprung's disease (n=3) or total colonic aganglionosis (Zuelzer-Wilson syndrome) (n=2). Median duration of individual stent placement was 23days (range, 1-87days). In all cases up to five different stents were placed over time. At follow-up two patients were successfully treated without further intervention. In another patient the anastomotic stricture resolved fully, but a coexisting enterocutaneous fistula persisted. Overall, three patients did not improve completely following stenting and required definite surgery. Stent-related problems were noted in all cases. There was one perforation of the colon at stent insertion. Further complications consisted of stent dislocation (n=4), obstruction (n=1), formation of granulation tissue (n=1), ulceration (n=1) and discomfort (n=3). Covered self-expandable stents enrich the armamentarium of interventions for benign colorectal disorders in children including anastomotic strictures and intestinal leaks. A stent can be applied either as an emergency procedure (bridge to surgery) or as an adjuvant treatment further to endoscopy and dilatation. Postinterventional problems are frequent but there is a potential for temporary or definite improvement following stent insertion. Copyright © 2017. Published by Elsevier Inc.

Biological effect on drug distribution and vascular healing via paclitaxel-coated balloon technology in drug eluting stent restenosis swine model.

PubMed

Li, Yan; Tellez, Armando; Rousselle, Serge D; Dillon, Krista N; Garza, Javier A; Barry, Chris; Granada, Juan F

2016-07-01

To evaluate the biological effect of a paclitaxel-coated balloon (PCB) technology on vascular drug distribution and healing in drug eluting stent restenosis (DES-ISR) swine model. The mechanism of action and healing response via PCB technology in DES-ISR is not completely understood. A total of 27 bare metal stents were implanted in coronary arteries and 30 days later the in-stent restenosis was treated with PCB. Treated segments were harvested at 1 hr, 14 days and 30 days post treatment for the pharmacokinetic analysis. In addition, 24 DES were implanted in coronary arteries for 30 days, then all DES-ISRs were treated with either PCB (n = 12) or uncoated balloon (n = 12). At day 60, vessels were harvested for histology following angiography and optical coherence tomography (OCT). The paclitaxel level in neointimal tissue was about 18 times higher (P = 0.0004) at 1 hr Cmax , and retained about five times higher (P = 0.008) at day 60 than that in vessel wall. A homogenous distribution of paclitaxel in ISR was demonstrated by using fluorescently labeled paclitaxel. Notably, in DES-ISR, both termination OCT and quantitative coronary angioplasty showed a significant neointimal reduction and less late lumen loss (P = 0.05 and P = 0.03, respectively) post PCB versus post uncoated balloon. The PES-ISR + PCB group displayed higher levels of peri-strut inflammation and fibrin scores compared to the -limus DES-ISR + PCB group. In ISR, paclitaxel is primarily deposited in neointimal tissue and effectively retained over time following PCB use. Despite the presence of metallic struts, a uniform distribution was characterized. PCB demonstrated an equivalent biological effect in DES-ISR without significantly increasing inflammation. © 2015 Wiley Periodicals, Inc. © 2015 Wiley Periodicals, Inc.

Impact of Paclitaxel Dose on Tissue Pharmacokinetics and Vascular Healing: A Comparative Drug-Coated Balloon Study in the Familial Hypercholesterolemic Swine Model of Superficial Femoral In-Stent Restenosis.

PubMed

Gongora, Carlos A; Shibuya, Masahiko; Wessler, Jeffrey D; McGregor, Jenn; Tellez, Armando; Cheng, Yanping; Conditt, Gerard B; Kaluza, Greg L; Granada, Juan F

2015-07-01

This study sought to compare the effect of paclitaxel-coated balloon (PCB) concentration on tissue levels and vascular healing using 3 different PCB technologies (In.Pact Pacific = 3 μg/mm(2), Lutonix = 2 μg/mm(2) and Ranger = 2 μg/mm(2)) in the experimental setting. The optimal therapeutic dose for PCB use has not been determined yet. Paclitaxel tissue levels were measured up to 60 days following PCB inflation (Ranger and In.Pact Pacific) in the superficial femoral artery of healthy swine (18 swine, 36 vessels). The familial hypercholesterolemic swine model of superficial femoral artery in-stent restenosis (6 swine, 24 vessels) was used in the efficacy study. Two weeks following bare-metal stent implantation, each in-stent restenosis site was randomly treated with a PCB or an uncoated control balloon (Sterling). Quantitative vascular analysis and histology evaluation was performed 28 days following PCB treatment. All PCB technologies displayed comparable paclitaxel tissue levels 4 h following balloon inflation. At 28 days, all PCB had achieved therapeutic tissue levels; however, the In.Pact PCB resulted in higher tissue concentrations than did the other PCB groups at all time points. Neointimal inhibition by histology was decreased in all PCB groups compared with the control group, with a greater decrease in the In.Pact group. However, the neointima was more mature and contained less peri-strut fibrin deposits in both 2-μg/mm(2) PCB groups. Compared with the clinically established PCB dose, lower-dose PCB technologies achieve lower long-term tissue levels but comparable degrees of neointimal inhibition and fewer fibrin deposits. The impact of these findings in restenosis reduction and clinical outcomes needs to be further investigated. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Biological effect on drug distribution and vascular healing via paclitaxel‐coated balloon technology in drug eluting stent restenosis swine model

PubMed Central

Li, Yan; Tellez, Armando; Rousselle, Serge D.; Dillon, Krista N.; Garza, Javier A.; Barry, Chris

2015-01-01

Objectives To evaluate the biological effect of a paclitaxel‐coated balloon (PCB) technology on vascular drug distribution and healing in drug eluting stent restenosis (DES‐ISR) swine model. Background The mechanism of action and healing response via PCB technology in DES‐ISR is not completely understood. Methods A total of 27 bare metal stents were implanted in coronary arteries and 30 days later the in‐stent restenosis was treated with PCB. Treated segments were harvested at 1 hr, 14 days and 30 days post treatment for the pharmacokinetic analysis. In addition, 24 DES were implanted in coronary arteries for 30 days, then all DES‐ISRs were treated with either PCB (n = 12) or uncoated balloon (n = 12). At day 60, vessels were harvested for histology following angiography and optical coherence tomography (OCT). Results The paclitaxel level in neointimal tissue was about 18 times higher (P = 0.0004) at 1 hr C max, and retained about five times higher (P = 0.008) at day 60 than that in vessel wall. A homogenous distribution of paclitaxel in ISR was demonstrated by using fluorescently labeled paclitaxel. Notably, in DES‐ISR, both termination OCT and quantitative coronary angioplasty showed a significant neointimal reduction and less late lumen loss (P = 0.05 and P = 0.03, respectively) post PCB versus post uncoated balloon. The PES‐ISR + PCB group displayed higher levels of peri‐strut inflammation and fibrin scores compared to the ‐limus DES‐ISR + PCB group. Conclusions In ISR, paclitaxel is primarily deposited in neointimal tissue and effectively retained over time following PCB use. Despite the presence of metallic struts, a uniform distribution was characterized. PCB demonstrated an equivalent biological effect in DES‐ISR without significantly increasing inflammation. © 2015 Wiley Periodicals, Inc. PMID:26613810

Pathological mechanisms of left main stent failure.

PubMed

Mori, Hiroyoshi; Torii, Sho; Harari, Emanuel; Jinnouchi, Hiroyuki; Brauman, Ryan; Smith, Samantha; Kutys, Robert; Fowler, David; Romero, Maria; Virmani, Renu; Finn, Aloke V

2018-07-15

Despite the increasing use of left main (LM) percutaneous coronary intervention (LM-PCI), there have been no pathological studies devoted to understanding the causes of LM stent failure. We aimed to systematically determine the pathological mechanisms of LM stent failure. From the CVPath Stent registry, a total of 46 lesions were identified to have LM-PCI. Pathologic stent failure (PSF) was defined as stent thrombosis, restenosis and in-stent chronic total occlusion (CTO). Failed and patent LM stented lesions were pathologically assessed to determine predictors of PSF. Malapposition and uncovered struts were numerically greater in the LM ostium, body, and bifurcation while neointimal thickness was relatively greater in bifurcation and proximal circumflex. In this study cohort, half of the lesions (n = 23) showed PSF. Stent thrombosis (ST, n = 18) was the major mode of PSF followed by in-stent CTO (n = 4) and restenosis (n = 1). Failed lesions showed significantly greater prevalence of malapposition >20% of struts/section (65% vs. 13%, P < 0.01), stent struts crossing an ostial side branch >30% of the circumference (48% vs. 13%, P < 0.01) and uncovered struts >30% (57% vs. 18%, P = 0.03). In multivariate analysis, the prevalence of malapposition >20% was the strongest risk factor for PSF (Odds ratio 8.0, 95% confidence interval 1.8-45.4, P < 0.01) followed by struts crossing an ostial side branch >30% (Odds ratio 4.2, 95% confidence interval 0.8-24.7, P = 0.09). Our data demonstrate the main pathological predictors for LM stent failure are malapposition and struts crossing an ostial side branch and suggest that imaging-guided PCI may be important. Copyright © 2018 Elsevier B.V. All rights reserved.

Distal Embolization After Stenting of the Vertebral Artery: Diffusion-Weighted Magnetic Resonance Imaging Findings

DOE Office of Scientific and Technical Information (OSTI.GOV)

Canyigit, Murat; Arat, Anil; Cil, Barbaros E.

2007-04-15

Purpose. We retrospectively evaluated our experience with stenting of the vertebral artery in an effort to determine the risk of distal embolization associated with the procedure. Methods. Between June 2000 and May 2005, 35 patients with 38 stenting procedures for atherosclerotic disease of the vertebral origin in our institution were identified. The average age of the patients was 60.3 years (range 32-76 years). Sixteen of these patients (with 18 stents) had MR imaging of the brain with diffusion-weighted imaging and an apparent diffusion coefficient map within 2 days before and after procedure. Results. On seven of the 16 postprocedural diffusion-weightedmore » MR images, a total of 57 new hyperintensities were visible. All these lesions were focal in nature. One patient demonstrated a new diffusion-weighted imaging abnormality in the anterior circulation without MR evidence of posterior circulation ischemia. Six of 16 patients had a total of 25 new lesions in the vertebrobasilar circulation in postprocedural diffusion-weighted MR images. One patient in this group was excluded from the final analysis because the procedure was complicated by basilar rupture during tandem stent deployment in the basilar artery. Hence, new diffusion-weighted imaging abnormalities were noted in the vertebrobasilar territory in 5 of 15 patients after 17 stenting procedures, giving a 29% rate of diffusion-weighted imaging abnormalities per procedure. No patient with bilateral stenting had new diffusion-weighted imaging abnormalities. Conclusion. Stenting of stenoses of the vertebral artery origin may be associated with a significant risk of asymptomatic distal embolization. Angiography, placement of the guiding catheter, inflation of the stent balloon, and crossing the lesion with guidewires or balloon catheters may potentially cause distal embolization. Further studies to evaluate measures to increase the safety of vertebral artery stenting, such as the use of distal protection devices or short-term postprocedural anticoagulation, should be considered for patients with clear indications for this procedure.« less

Stent placement vs. balloon angioplasty for popliteal artery treatment: two-year results of a prospective, multicenter, randomized trial.

PubMed

Rastan, Aljoscha; Krankenberg, Hans; Baumgartner, Iris; Blessing, Erwin; Müller-Hülsbeck, Stefan; Pilger, Ernst; Scheinert, Dierk; Lammer, Johannes; Beschorner, Ulrich; Noory, Elias; Neumann, Franz-Josef; Zeller, Thomas

2015-02-01

To investigate the 2-year technical and clinical results of primary nitinol stent placement in comparison with percutaneous transluminal angioplasty (PTA) in the treatment of de novo lesions of the popliteal artery. The ETAP study (Endovascular Treatment of Atherosclerotic Popliteal Artery Lesions: balloon angioplasty vs. primary stenting; www.ClinicalTrials.gov identifier NCT00712309) is a prospective, randomized trial that enrolled 246 patients (158 men; mean age 72 years) who were randomly assigned to receive a nitinol stent (n=119) or PTA (n=127) for lesions averaging 42.3 mm in length. The results of the primary study endpoint were published. Secondary outcome measures and endpoints included primary patency (freedom from duplex-detected target lesion restenosis), target lesion revascularization (TLR), secondary patency, changes in ankle-brachial index and Rutherford class, and event-free survival (freedom from target limb amputation, TLR, myocardial infarction, and death). In total, 183 patients (89 stent and 94 PTA) were available for the 2-year analysis. The primary patency rate was significantly higher in the stent group (64.2%) than in the PTA group (31.3%, p=0.0001). TLR rates were 22.4% and 59.5%, respectively (p=0.0001). When provisional stent placement in the PTA arm was not considered as TLR and loss in patency, the differences prevailed between the study groups but were not significant (64.2% vs. 56.1% for primary patency, respectively; p=0.44). A significant improvement in ABI and Rutherford category was observed at 2 years in both groups. In treatment of obstructive popliteal artery lesions, provisional stenting reveals equivalent patency in comparison to primary stenting. However, the 2-year results of this trial suggest the possibility of a shift toward higher patency rates in favor of primary stenting. © The Author(s) 2015.

Comparative Analysis of Sequential Proximal Optimizing Technique Versus Kissing Balloon Inflation Technique in Provisional Bifurcation Stenting: Fractal Coronary Bifurcation Bench Test.

PubMed

Finet, Gérard; Derimay, François; Motreff, Pascal; Guerin, Patrice; Pilet, Paul; Ohayon, Jacques; Darremont, Olivier; Rioufol, Gilles

2015-08-24

This study used a fractal bifurcation bench model to compare 6 optimization sequences for coronary bifurcation provisional stenting, including 1 novel sequence without kissing balloon inflation (KBI), comprising initial proximal optimizing technique (POT) + side-branch inflation (SBI) + final POT, called "re-POT." In provisional bifurcation stenting, KBI fails to improve the rate of major adverse cardiac events. Proximal geometric deformation increases the rate of in-stent restenosis and target lesion revascularization. A bifurcation bench model was used to compare KBI alone, KBI after POT, KBI with asymmetric inflation pressure after POT, and 2 sequences without KBI: initial POT plus SBI, and initial POT plus SBI with final POT (called "re-POT"). For each protocol, 5 stents were tested using 2 different drug-eluting stent designs: that is, a total of 60 tests. Compared with the classic KBI-only sequence and those associating POT with modified KBI, the re-POT sequence gave significantly (p < 0.05) better geometric results: it reduced SB ostium stent-strut obstruction from 23.2 ± 6.0% to 5.6 ± 8.3%, provided perfect proximal stent apposition with almost perfect circularity (ellipticity index reduced from 1.23 ± 0.02 to 1.04 ± 0.01), reduced proximal area overstretch from 24.2 ± 7.6% to 8.0 ± 0.4%, and reduced global strut malapposition from 40 ± 6.2% to 2.6 ± 1.4%. In comparison with 5 other techniques, the re-POT sequence significantly optimized the final result of provisional coronary bifurcation stenting, maintaining circular geometry while significantly reducing SB ostium strut obstruction and global strut malapposition. These experimental findings confirm that provisional stenting may be optimized more effectively without KBI using re-POT. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Doros, Attila, E-mail: dorattila@yahoo.com; Nemeth, Andrea; Deak, Akos Pal

The role of covered stent in the management of biliary complications is not yet defined in liver transplant recipients. This Case Report presents a patient with anastomotic stricture and leakage with biloma treated with a covered stent 32 months following liver transplantation. Signs of in-stent restenosis developed 52 months following covered stent placement, which was resolved by balloon dilation. There were no complications during the interventions. The latest follow-up, at 69 months following primary and 19 months following secondary percutaneous intervention, shows a patent covered stent without any clinical or morphological sign of further restenosis. The clinical success with long-termmore » follow-up data suggests that covered stent implantation can be a rational, minimally invasive option for simultaneous treatment of bile duct stenosis and bile leak following liver transplantation in selected cases.« less

Use of self-expandable plastic stents for the treatment of esophageal perforations and symptomatic anastomotic leaks.

PubMed

Gelbmann, C M; Ratiu, N L; Rath, H C; Rogler, G; Lock, G; Schölmerich, J; Kullmann, F

2004-08-01

Extensive anastomotic leaks after esophageal resection and esophageal perforations are a therapeutic challenge. The aim of the present study was to assess the potential of the self-expandable Polyflex plastic stent for the treatment of these conditions. Between January 2002 and March 2003, nine patients were treated with a self-expandable Polyflex plastic stent for sealing of thoracic esophagoenteric anastomotic leaks following surgical resection (n = 5) or esophageal perforation (n = 4). In all patients the stents were inserted successfully without technical problems. In all but two patients complete sealing of the leak was achieved as demonstrated by radiography with water-soluble contrast media. The stent migration rate was 30 % and repositioning of the migrated stents was possible in all cases. Complete mucosal healing of the esophageal leaks and stent extraction was achieved in six patients. The stents were in situ for an average period of 135 +/- 78 days. Two critically ill patients with anastomotic leaks died in spite of stent insertion due to sepsis and one patient with esophageal perforation died due to the underlying malignant disease. Our preliminary experience with the self-expanding and removable Polyflex plastic stent for the sealing of anastomotic leaks and esophageal perforations suggests that this stent is a feasible treatment option, in particular, for more extensive esophageal defects, patients with co-morbid conditions, and critically ill patients.

Obstruction after Self-expanding Metallic Stents in Tuberculous Bronchial Stenosis

PubMed Central

Kim, Won; Lee, Youg Chul; Rhee, Yang Keun

1995-01-01

Expandable metallic stents seemed to be a good method in tuberculous bronchial stenosis that does not respond to medical therapy. But there was no long-term follow-up study after stents insertion in tuberculous bronchial stenosis. We report a case of obstruction after successful Gianturco metallic stents insertion due to tuberculous bronchial stenosis. PMID:7542914

Clinical Outcomes of Drug-Coated Balloons in Coronary Artery Disease Unsuitable for Drug-Eluting Stent Implantation.

PubMed

Iijima, Raisuke; Kougame, Norihiro; Hara, Hidehiko; Moroi, Masao; Nakamura, Masato

2018-06-12

The aim of this study was to investigate whether drug-coated balloon (DCB) treatment is effective for de novo coronary lesions that are unsuitable for drug-eluting stent (DES) implantation.Methods and Results:This retrospective study included 118 de novo lesions that were not suitable for DES implantation. Of the lesions, 40% was treated because of very small vessel disease. Patients with planned non-cardiac surgery and at high bleeding risk were 3% and 19%, respectively, and lesions that easily develop stent fracture comprised 26%. Clinically driven target lesion revascularization (TLR) was the primary endpoint. The rate of suboptimal lesion preparation before DCB treatment was set as the secondary endpoint. Optimal lesion preparation was defined as acquisition of Thrombolysis in Myocardial Infarction flow grade 3, minor coronary dissection, and residual stenosis ≤30%. The rate of suboptimal lesion preparation was 2.5% and 3 patients needed bail-out stenting. Accordingly, 115 patients were treated with a DCB. Clinically driven TLR had occurred in 8 patients (7.0%) at the 8-month follow-up. The presence of chronic total occlusion was identified as an independent predictor for TLR (odds 11.57; 95% confidence interval, 1.38-135.54; P=0.02). For lesions that are unsuitable for stent implantation, stent-less intervention using a DCB should be considered initially. The present study also highlighted that lesion preparation is key to a successful DCB strategy.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ozkan, Ugur, E-mail: radugur@yahoo.com; Oguzkurt, Levent, E-mail: loguzkurt@yahoo.com; Tercan, Fahri, E-mail: ftercan@yahoo.com

The aim of this study was to report our experience in endovascular treatment of total aortoiliac occlusion. Five patients who underwent endovascular recanalization procedures including manual aspiration thrombectomy, balloon angioplasty, and stent placement for total aortoiliac occlusion in a 4-year period were reviewed retrospectively. The mean age of patients was 51 years (range, 43 to 58 years). All patients had abdominal aorta and bilateral common iliac artery occlusion with or without external iliac artery occlusion. All patients either had a contraindication to surgery or refused it. Initial technical success was obtained in four of five (80%) patients. Endovascular techniques weremore » successful in four patients who had good distal runoff and short-segment aortoiliac occlusion, but failed in a patient who had the worst distal runoff and long-segment aortoiliac occlusion. We observed two major complications, one of which was bilateral rupture of the common iliac arteries treated with covered stent placement. Another patient had extension of intra-aortic thrombus into the iliac stent after primary stenting. This was successfully treated with manual aspiration thrombectomy. Aortic and iliac stents remained patent during the follow-up period (median, 18 months; range, 3 to 26 months) in four patients. Primary patency rates at 6, 12, and 24 months were all 80%. In conclusion, endovascular treatment can be an alternative for aortoiliac occlusion in selected patients. Short- to midterm follow-up so far is satisfactory. Removal of intra-aortic thrombus with manual aspiration thrombectomy before balloon angioplasty and/or stenting is possible and a good alternative to thrombolysis.« less

Triple In Situ Antegrade Laser Fenestration of Aortic Stent-Graft Extension Using Fusion Imaging for Urgent Treatment of Symptomatic Abdominal Aneurysm with Type 1 Endoleak.

PubMed

Touma, Joseph; Kobeiter, Hicham; Majewski, Marek; Tacher, Vania; Desgranges, Pascal

2018-03-01

The present report describes the management of massive proximal type 1 endoleak with an enlarged symptomatic aneurysmal sac. Urgent treatment was performed using in situ laser fenestration of an aortic proximal extension facing renovisceral ostia. Image fusion was obtained intraoperatively. For each target vessel (superior mesenteric and two renal arteries), an Aptus HeliFX steerable sheath (Medtronic) inserted through femoral access was curved to face the vessel's ostium marker. A laser catheter (Spectranetics) was used to traverse the stent-graft and insert a 0.014" guidewire in the vessel. The fenestration was enlarged using a 2.5-mm-diameter cutting balloon, followed by a 4-mm-diameter balloon angioplasty and a V12 I Cast/Advanta covered stent implantation. Final angiogram demonstrated aneurysm exclusion and patent target vessels. The postoperative course and 7 months follow-up were uneventful. Level of evidence Level 4.

An approach to tracheostomy in a patient with an expandable metallic tracheal stent.

PubMed

Madden, Brendan P; Sheth, Abhijat

2005-09-01

With increasing use of expandable metallic stents to manage patients with a variety of endobronchial pathologies, some will have a subsequent need for tracheostomy insertion. We describe a successful technique to insert a tracheostomy using rigid and fibre-optic bronchoscopy in a patient who had an 8 cm expandable metallic tracheal stent deployed previously on account of tracheomalacia.

Carotid artery stenting with double cerebral embolic protection in asymptomatic patients - a diffusion-weighted MRI controlled study.

PubMed

Vuruskan, Ertan; Saracoglu, Erhan; Ergun, Ugur; Poyraz, Fatih; Duzen, İrfan Veysel

2017-01-01

The aim of this study was to compare the simultaneous double-protection method (proximal balloon plus distal filter) with distal-filter protection or proximal-balloon protection alone in asymptomatic patients during carotid artery stenting. 119 consecutive patients were investigated for carotid artery stentings in the extracranial internal carotid artery with the use of distal filters (n = 41, 34.4 %), proximal balloon (MoMa) protection (n = 40, 33.6 %) or double protection (n = 38, 31.9 %). Magnetic resonance imaging (MRI) was performed on all patients before the procedure, and control diffusion-weighted MRI (DW-MRI) was obtained within 24-48 h after the procedure. Procedural data, complications, success rate, major adverse cardiovascular events, and MRI findings were collected. New cerebral high-intensity (HI) lesions were observed in 47 (39.4 %) patients. HI lesions were observed in 22 (53.6 %), 15 (37.5 %), and 10 (26.3 %) of the patients with distal filters, proximal protection, and double protection, respectively (p = 0.004). The average number of HI lesions on DW-MRI was 1.80 in the distal-filter group, 0.90 in the proximal-balloon group, and 0.55 in the double-protection group (p < 0.001). Procedure and fluoroscopy times were slightly longer in the double-protection group compared to the distal- or proximal-protection groups (p = 0.001). The double (proximal plus distal) cerebral embolic protection technique is safe and effective for minimizing the risk of cerebral embolization, even in patients with asymptomatic carotid artery stenosis, despite slightly longer procedure and fluoroscopy times.
.

Endovascular rescue of a fused monorail balloon and cerebral protection device.

PubMed

Campbell, John E; Bates, Mark C; Elmore, Michael

2007-08-01

To present a case of successful endovascular retrieval of a monorail predilation balloon fused to an embolic protection device (EPD) in the distal internal carotid artery (ICA) of a high-risk symptomatic patient. A 60-year-old man with documented systemic atherosclerotic disease had a severe (>70%) restenosis in the left ICA 3 years after endarterectomy. He was scheduled for carotid artery stenting (CAS) with cerebral protection; however, he developed unstable angina and was transferred to our facility, where the admitting team decided that staged CAS followed by coronary bypass grafting would be the best option. During the CAS procedure, a 6-mm AccuNet filter was passed across the lesion via a 6-F carotid sheath and deployed in the distal ICA without incident. However, the 4-x20-mm predilation monorail balloon was then advanced without visualizing the markers, resulting in inadvertent aggressive interaction that trapped the balloon's tip in the filter. Several maneuvers to separate the devices were unsuccessful. Finally, the filter/balloon combination was moved gently retrograde until the balloon was straddling the subtotal ICA lesion. The lesion was dilated to 4 mm with the balloon, and the sheath was gently advanced across the lesion as the balloon was deflated. Angiography excluded interval occlusion of the filter from the embolic debris during the aforementioned aggressive maneuvers and documented antegrade flow. The filter was slowly withdrawn into the 6-F sheath with simultaneous aspiration. A second 6-mm filter was deployed, and the procedure was completed satisfactorily. The patient did well, with no neurological sequelae. EPDs are an essential in carotid artery stenting and, keeping in mind the potential risks associated with their use, will help the operator avoid complications such as this one.

Novel 3D-CT evaluation of carotid stent volume: greater chronological expansion of stents in patients with vulnerable plaques.

PubMed

Itami, Hisakazu; Tokunaga, Koji; Okuma, Yu; Hishikawa, Tomohito; Sugiu, Kenji; Ida, Kentaro; Date, Isao

2013-09-01

Although self-expanding carotid stents may dilate gradually, the degrees of residual stenosis have been quantified by the NASCET criteria, which is too simple to reflect the configuration of the stented artery. We measured the volumes of the stent lumens chronologically by 3D-CT in patients after carotid artery stenting (CAS), and analyzed the correlations between the volume change and medical factors. Fourteen patients with carotid artery stenosis were treated using self-expanding, open-cell stents. All patients underwent preoperative plaque MRI (magnetization-prepared rapid acquisition gradient-echo, MPRAGE) and chronological 3D-CT examinations of their stents immediately after their placement and 1 day, 1 week, and 1 month after the procedure. The volume of the stent lumen was measured using a 3D workstation. The correlations between stent volume and various factors including the presence of underlying diseases, plaque characteristics, and the results of the CAS procedure were analyzed. Stent volume gradually increased in each case and had increased by 1.04-1.55 (mean, 1.25)-fold at 1 postoperative month. The presence of underlying medical diseases, plaque length, the degree of residual stenosis immediately after CAS, and plaque calcification did not have an impact on the change in stent volume. On the other hand, the stent volume increase was significantly larger in the patients with vulnerable plaques that demonstrated high MPRAGE signal intensity (P < 0.05). A 3D-CT examination is useful for precisely measuring stent volume. Self-expanding stents in carotid arteries containing vulnerable plaques expand significantly more than those without such plaques in a follow-up period.

Which way in? The Necessity of Multiple Approaches to Transcatheter Valve Therapy

PubMed Central

Bleiziffer, S.; Krane, M.; Deutsch, M.A.; Elhmidi, Y.; Piazza, N.; Voss, B.; Lange, R.

2013-01-01

TAVI (transcatheter aortic valve implantation) is a less invasive treatment of the stenotic aortic valve while avoiding midline sternotomy and cardiopulmonary bypass. A crimped biological valve on a self-expanding or balloon-expandable stent is inserted antegradely or retrogradely under fluoroscopy, and deployed on the beating heart. Among the worldwide TAVI programs, many different concepts have been established for the choice of the access site. Whether retrograde or antegrade TAVI should be considered the superior approach is matter of an ongoing debate. The published literature demonstrates safety of all techniques if performed within a dedicated multidisciplinary team. Since there is no data providing evidence if one approach is superior to another, we conclude that an individualized patient-centered decision making process is most beneficial, taking advantage of the complementarity of the different access options. The aim of this article is to give an overview of the current practice of access techniques for transcatheter based valve treatment and to outline the respective special characteristics. PMID:24313647

Treatment of esophagopleural fistulas using covered retrievable expandable metallic stents.

PubMed

Kim, Tae-Hyung; Shin, Ji Hoon; Kim, Kyung Rae; Park, Jung-Hoon; Kim, Jin Hyoung; Song, Ho-Young

2014-04-01

To evaluate the clinical efficacy of placement of covered retrievable expandable metallic stents for esophagopleural fistulas (EPFs). During the period 1997-2013, nine patients with EPF were treated using covered retrievable expandable metallic stents. The underlying causes of EPF were esophageal carcinoma (n = 6), lung cancer (n = 2), and postoperative empyema for Boerhaave syndrome (n = 1). Technical success was achieved in eight patients (88.9%). In one patient, incomplete EPF closure was due to incomplete stent expansion. Clinical success, defined as complete EPF closure within 7 days, was achieved in five patients (55.6%). Overall fistula persistence (n = 1) or reopening (n = 4) occurred in five patients (55.6%) 0-15 days after stent placement. The causes of reopening were due to the gap between the stent and the esophagus (n = 3) or stent migration (n = 1). For fistula persistence or reopening, additional interventional management, such as gastrostomy, stent removal, or stent reinsertion, was performed. Stent migration occurred as a complication in one patient with EPF from a benign cause secondary to postoperative empyema. In the eight patients who died during the follow-up period, the mean and median survival times were 78.8 days and 46 days, respectively. Placement of a covered expandable metallic esophageal stent for the palliative treatment of EPF is technically feasible, although the rate of clinical success was poor secondary to fistula persistence or reopening. Fistula reopening was caused by the gap between the stent and the esophagus or by stent migration, and additional interventional treatment was useful to ensure enteral nutritional support. Copyright © 2014 SIR. Published by Elsevier Inc. All rights reserved.

Fully covered self-expandable metal stents (SEMS), partially covered SEMS and self-expandable plastic stents for the treatment of benign esophageal ruptures and anastomotic leaks.

PubMed

van Boeckel, Petra G A; Dua, Kulwinder S; Weusten, Bas L A M; Schmits, Ruben J H; Surapaneni, Naveen; Timmer, Robin; Vleggaar, Frank P; Siersema, Peter D

2012-02-29

Benign esophageal ruptures and anastomotic leaks are life-threatening conditions that are often treated surgically. Recently, placement of partially and fully covered metal or plastic stents has emerged as a minimally invasive treatment option. We aimed to determine the clinical effectiveness of covered stent placement for the treatment of esophageal ruptures and anastomotic leaks with special emphasis on different stent designs. Consecutive patients who underwent placement of a fully covered self-expandable metal stent (FSEMS), a partially covered SEMS (PSEMS) or a self-expanding plastic stent (SEPS) for a benign esophageal rupture or anastomotic leak after upper gastrointestinal surgery in the period 2007-2010 were included. Data on patient demographics, type of lesion, stent placement and removal, clinical success and complications were collected A total of 52 patients received 83 esophageal stents (61 PSEMS, 15 FSEMS, 7 SEPS) for an anastomotic leak (n=32), iatrogenic rupture (n=13), Boerhaave's syndrome (n=4) or other cause (n=3). Endoscopic stent removal was successful in all but eight patients treated with a PSEMS due to tissue ingrowth. Clinical success was achieved in 34 (76%, intention-to-treat: 65%) patients (PSEMS: 73%, FSEMS: 83%, SEPS: 83%) after a median of 1 (range 1-5) stent and a median stenting time of 39 (range 7-120) days. In total, 33 complications in 24 (46%) patients occurred (tissue in- or overgrowth (n=8), stent migration (n=10), ruptured stent cover (all Ultraflex; n=6), food obstruction (n=3), severe pain (n=2), esophageal rupture (n=2), hemorrhage (n=2)). One (2%) patient died of a stent-related cause. Covered stents placed for a period of 5-6 weeks may well be an alternative to surgery for treating benign esophageal ruptures or anastomotic leaks. As efficacy between PSEMS, FSEMS and SEPS is not different, stent choice should depend on expected risks of stent migration (SEPS and FSEMS) and tissue in- or overgrowth (PSEMS).

Self-Expandable Metallic Stent Placement for the Palliation of Esophageal Cancer

PubMed Central

2017-01-01

Esophageal stents have been used to palliate patients with dysphagia caused by esophageal cancer. Early rigid plastic prostheses have been associated with a high risk of complications. However, with the development of self-expanding stents, it has developed into a widely accepted method for treating malignant esophageal strictures and esophagorespiratory fistulas (ERFs). The present review covers various aspects of self-expanding metallic stent placement for palliating esophageal cancer, including its types, placement procedures, indications, contraindications, complications, and some of innovations that will become available in the future. PMID:28581260

Two Blades-Up Runs Using the JetStream Navitus Atherectomy Device Achieve Optimal Tissue Debulking of Nonocclusive In-Stent Restenosis: Observations From a Porcine Stent/Balloon Injury Model.

PubMed

Shammas, Nicolas W; Aasen, Nicole; Bailey, Lynn; Budrewicz, Jay; Farago, Trent; Jarvis, Gary

2015-08-01

To determine the number of runs with blades up (BU) using the JetStream Navitus to achieving optimal debulking in a porcine model of femoropopliteal artery in-stent restenosis (ISR). In this porcine model, 8 limbs were implanted with overlapping nitinol self-expanding stents. ISR was treated initially with 2 blades-down (BD) runs followed by 4 BU runs (BU1 to BU4). Quantitative vascular angiography (QVA) was performed at baseline, after 2 BD runs, and after each BU run. Plaque surface area and percent stenosis within the treated stented segment were measured. Intravascular ultrasound (IVUS) was used to measure minimum lumen area (MLA) and determine IVUS-derived plaque surface area. QVA showed that plaque surface area was significantly reduced between baseline (83.9%±14.8%) and 2 BD (67.7%±17.0%, p=0.005) and BU1 (55.4%±9.0%, p=0.005) runs, and between BU1 and BU2 runs (50.7%±9.7%, p<0.05). Percent stenosis behaved similarly with no further reduction after BU2. There were no further reductions in plaque surface area or percent stenosis with BU 3 and 4 runs (p=0.10). Similarly, IVUS (24 lesions) confirmed optimal results with BU2 runs and no additional gain in MLA or reduction in plaque surface area with BU3 and 4. IVUS confirmed no orbital cutting with JetStream Navitus. There were no stent strut discontinuities on high-resolution radiographs following atherectomy. JetStream Navitus achieved optimal tissue debulking after 2 BD and 2 BU runs with no further statistical gain in debulking after the BU2 run. Operators treating ISR with JetStream Navitus may be advised to limit their debulking to 2 BD and 2 BU runs to achieve optimal debulking. © The Author(s) 2015.

Early experimental and clinical experience with a focal implant for lower extremity post-angioplasty dissection.

PubMed

Schneider, Peter A; Giasolli, Robert; Ebner, Adrian; Virmani, Renu; Granada, Juan F

2015-02-01

This study provides preliminary data on the safety and feasibility of the use of a novel focal implant for managing post-percutaneous transluminal balloon angioplasty (post-PTA) dissection. Post-PTA dissection of the lower extremity arteries is managed with stent placement. This provides an acceptable post-intervention result but has long-term disadvantages, such as in-stent restenosis. Focal treatment of post-PTA dissection and avoidance of stents are the objectives of the Tack-It (Intact Vascular, Inc., Wayne, Pennsylvania) device. A preclinical study and first-in-human data are presented. Seven swine underwent superficial femoral artery device placement, with a self-expanding nitinol stent on 1 side and a series of 4 Tack-It devices on the other side. Specimens were harvested at 28 days. The clinical study included 15 limbs that underwent revascularization for critical limb ischemia (n = 9) or claudication (n = 6). Twenty-five lesions were treated in the superficial femoral (n = 8), popliteal (n = 7), and tibial (n = 10) arteries. The preclinical study demonstrated a reduction in stenosis with the Tack-It (16.8 ± 2.6%) compared with stents (46.4 ± 9.8%). Neointimal thickness and injury score decreased with the Tack-It. Clinically, Tack-It placement resulted in acute technical success with resolution of the post-PTA dissection in 100% of lesions. There were no device-related complications or major amputations. Eighteen of the 25 lesions were available for angiographic follow-up at 1-year, and patency was 83.3%. Preclinical data suggest that the Tack-It device causes minimal vessel injury. Clinical use of the Tack-It to manage post-PTA dissection was safe and feasible in this early study and resulted in apposition of dissection flaps without stent placement. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Hybrid treatment of tandem, common carotid/innominate artery and ipsilateral carotid bifurcation stenoses by simultaneous, retrograde proximal stenting and eversion carotid endarterectomy: Preliminary results of a case series.

PubMed

Illuminati, Giulio; Pizzardi, Giulia; Pasqua, Rocco; Frezzotti, Francesca; Palumbo, Piergaspare; Macrina, Francesco; Calio', Francesco

2018-04-01

Tandem stenoses of the internal carotid artery (ICA) and proximal, ipsilateral common carotid artery (CCA) or innominate artery can be treated with a hybrid approach, combining conventional carotid endarterectomy (CEA) and retrograde stenting of the proximal stenosis, through surgical exposure of the carotid bifurcation. The purpose of this study was to evaluate the results of combining eversion CEA with retrograde CCA/innominate artery stenting. From January 2015 to July 2017, 7 patients, 6 men of a mean age of 72 years (range 59-83 years) underwent simultaneous, retrograde stenting of the proximal CCA/innominate artery and an eversion CEA of the ipsilateral ICA, through surgical exposure of the carotid bifurcation, for severe tandem stenoses. The proximal stenosis involved the left proximal CCA in 4 patients, the proximal innominate artery in 2 patients and the right CCA in one patient. The procedure was performed under general anesthesia in a conventional operating room equipped with a mobile C-arm. A covered, balloon expandable stent was deployed over the proximal stenosis via a 6-F sheath directly introduced into the proximal CCA through the obliquely transected carotid bulb. After removing the sheath, debris were flushed through the carotid bulb and eversion CEA completed the procedure. Study endpoints were: postoperative stroke/mortality rate, cardiac mortality and morbidity, peripheral nerve injury, cervical hematoma, overall late survival, freedom from ipsilateral stroke and patency of arterial reconstruction. No postoperative mortality or neurologic morbidity was observed in any patient. Cervical hematomas and peripheral nerve injuries were likewise absent. At a mean follow-up of 18 months, all the patients were alive, free from neurologic events of new onset and free from restenosis. Combined proximal stenting and eversion CEA for tandem lesions seems a valid treatment, with the advantages of eversion CEA over other techniques of carotid bifurcation revascularization. Copyright © 2018 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

Everolimus-Eluting Stents in Patients With Bare-Metal and Drug-Eluting In-Stent Restenosis: Results From a Patient-Level Pooled Analysis of the RIBS IV and V Trials.

PubMed

Alfonso, Fernando; Pérez-Vizcayno, María José; García Del Blanco, Bruno; García-Touchard, Arturo; López-Mínguez, José-Ramón; Masotti, Mónica; Zueco, Javier; Melgares, Rafael; Mainar, Vicente; Moreno, Raul; Domínguez, Antonio; Sanchís, Juan; Bethencourt, Armando; Moreu, José; Cequier, Angel; Martí, Vicens; Otaegui, Imanol; Bastante, Teresa; Gonzalo, Nieves; Jiménez-Quevedo, Pilar; Cárdenas, Alberto; Fernández, Cristina

2016-07-01

Treatment of patients with drug-eluting stent (DES) in-stent restenosis (ISR) is more challenging than that of patients with bare-metal stent ISR. However, the results of everolimus-eluting stents (EES) in these distinct scenarios remain unsettled. A pooled analysis of the RIBS IV (Restenosis Intra-Stent of Drug-Eluting Stents: Paclitaxel-Eluting Balloon vs Everolimus-Eluting Stent) and RIBS V (Restenosis Intra-Stent of Bare Metal Stents: Paclitaxel-Eluting Balloon vs Everolimus-Eluting Stent) randomized trials was performed using patient-level data to compare the efficacy of EES in bare-metal stent ISR and DES-ISR. Inclusion and exclusion criteria were identical in both trials. Results of 94 patients treated with EES for bare-metal stent ISR were compared with those of 155 patients treated with EES for DES-ISR. Baseline characteristics were more adverse in patients with DES-ISR, although they presented later and more frequently with a focal pattern. After intervention, minimal lumen diameter (2.22±0.5 versus 2.38±0.5 mm, P=0.01) was smaller in the DES-ISR group. Late angiographic findings (89.3% of eligible patients), including minimal lumen diameter (2.03±0.7 versus 2.36±0.6 mm, P<0.001) and diameter stenosis (23±22 versus 13±17%, P<0.001) were poorer in patients with DES-ISR. Results were consistent in the in-segment and in-lesion analyses. On multiple linear regression analysis, minimal lumen diameter at follow-up remained significantly smaller in patients with DES-ISR. Finally, at 1-year clinical follow-up (100% of patients), mortality (2.6 versus 0%, P<0.01) and need for target vessel revascularization (8 versus 2%, P=0.03) were higher in the DES-ISR group. This patient-level pooled analysis of the RIBS IV and RIBS V randomized clinical trials suggests that EES provide favorable outcomes in patients with ISR. However, the results of EES are less satisfactory in patients with DES-ISR than in those with bare-metal stent ISR. URL: http://www.clinicaltrials.gov. Unique identifiers: NCT01239953 and NCT01239940. © 2016 American Heart Association, Inc.

Malignant esophageal-tracheobronchial strictures: parallel placement of covered retrievable expandable nitinol stents.

PubMed

Nam, D H; Shin, J H; Song, H Y; Jung, G S; Han, Y M

2006-02-01

To assess the safety and clinical effectiveness of the parallel placement of covered retrievable expandable metallic stents in the palliative treatment of malignant esophageal and tracheobronchial strictures. Under fluoroscopic guidance, parallel stents were placed in 12 symptomatic patients with both malignant esophageal and tracheobronchial strictures. Seven of these 12 patients also had an esophagorespiratory fistula (ERF) and one patient had an esophagocutaneous fistula. Technical success, clinical improvement, complications, and survival rates were evaluated. A total of 28 esophageal and airway stents were successfully placed. The grade of dysphagia and dyspnea score significantly decreased after stent placement (P=0.002 and 0.003, respectively). ERF and esophagocutaneous fistula were sealed off in all eight patients after esophageal stent placement; however, the esophagocutaneous fistula reopened 1 month later. Complications included stent migration or expectoration (n=3), tracheal compression by the esophageal stent (n=3), new fistula development due to covering membrane degradation of the esophageal stent (n=1), and symptomatic sputum retention (n=1). Stent removal was easily performed for two stents; one migrated stent and the other with covering membrane degradation. All 12 patients died within the mean survival period of 72.50 days (range 7-375 days). Parallel placement of covered retrievable expandable metallic stents is safe and effective for the palliative treatment of malignant esophageal and tracheobronchial strictures.

Bleeding after expandable nitinol stent placement in patients with esophageal and upper gastrointestinal obstruction: incidence, management, and predictors.

PubMed

Oh, Se Jin; Song, Ho-Young; Nam, Deok Ho; Ko, Heung Kyu; Park, Jung-Hoon; Na, Han Kyu; Lee, Jong Jin; Kang, Min Kyoung

2014-11-01

Placement of self-expandable nitinol stents is useful for the treatment of esophageal and upper gastrointestinal (GI) obstruction. However, complications such as stent migration, tumor overgrowth, and bleeding occur. Although stent migration and tumor overgrowth are well documented in previous studies, the occurrence of bleeding has not been fully evaluated. To evaluate the incidence, management strategies, and predictors of bleeding after placement of self-expandable nitinol stents in patients with esophageal and upper GI obstruction. We retrospectively reviewed the medical records and results of computed tomography and endoscopy of 1485 consecutive patients with esophageal and upper GI obstructions who underwent fluoroscopically guided stent placement. Bleeding occurred in 25 of 1485 (1.7%) patients 0 to 348 days after stent placement. Early stent-related bleeding occurred in 10 patients (40%) and angiographic embolization was used for 5/10. Late bleeding occurred in 15 patients (60%) and endoscopic hemostasis was used for 7/15. Twenty-two of 25 (88%) patients with bleeding had received prior radiotherapy and/or chemotherapy. Bleeding is a rare complication after placement of expandable nitinol stents in patients with esophageal and upper GI obstruction, but patients with early bleeding may require embolization for control. Care must be exercised on placing stents in patients who have received prior radiotherapy or chemotherapy. © The Foundation Acta Radiologica 2013 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

Predictors of the patency of self-expandable metallic stents in malignant gastroduodenal obstruction.

PubMed

Kim, Seung Han; Chun, Hoon Jai; Yoo, In Kyung; Lee, Jae Min; Nam, Seung Joo; Choi, Hyuk Soon; Kim, Eun Sun; Keum, Bora; Seo, Yeon Seok; Jeen, Yoon Tae; Lee, Hong Sik; Um, Soon Ho; Kim, Chang Duck

2015-08-14

To investigate the predictive factors of self-expandable metallic stent patency after stent placement in patients with inoperable malignant gastroduodenal obstruction. A total of 116 patients underwent stent placements for inoperable malignant gastroduodenal obstruction at a tertiary academic center. Clinical success was defined as acceptable decompression of the obstructive lesion within the malignant gastroduodenal neoplasm. We evaluated patient comorbidities and clinical statuses using the World Health Organization's scoring system and categorized patient responses to chemotherapy using the Response Evaluation Criteria in Solid Tumors criteria. We analyzed the relationships between possible predictive factors and stent patency. Self-expandable metallic stent placement was technically successful in all patients (100%), and the clinical success rate was 84.2%. In a multivariate Cox proportional hazards model, carcinoembryonic antigen (CEA) levels were correlated with a reduction in stent patency [P = 0.006; adjusted hazard ratio (aHR) = 2.92, 95%CI: 1.36-6.25]. Palliative chemotherapy was statistically associated with an increase in stent patency (P = 0.009; aHR = 0.27, 95%CI: 0.10-0.72). CEA levels can easily be measured at the time of stent placement and may help clinicians to predict stent patency and determine the appropriate stent procedure.

Fully Covered Self-Expandable Metal Stents for Treatment of Both Benign and Malignant Biliary Disorders

PubMed Central

Abdel Samie, Ahmed; Theilmann, Lorenz

2012-01-01

Transpapillary stents are increasingly being used for biliary strictures, whether benign or malignant. However, there are different stent types and available data is controversial. Recently, completely covered self-expandable metal stents (CSEMSs) have been proposed as an alternative therapeutic option in different biliary indications, including strictures of the distal bile duct, anastomotic stenosis after orthotopic liver transplantation, bile duct leaks, periampullary perforation following endoscopic sphincterotomy (ES), and postsphincterotomy bleeding. Despite the higher costs of these devices, fully covered self-expanding metal stents seem to be a suitable therapeutic option to relief biliary obstruction due to bile duct stenosis, regardless of the underlying cause. PMID:22761543

Renal artery stent fracture with refractory hypertension: a case report and review of the literature.

PubMed

Chua, Su-Kiat; Hung, Huei-Fong

2009-07-01

A 73-year-old man with resistant hypertension and impaired renal function underwent stenting for right renal artery (RRA) stenosis. Two years later, he presented with uncontrolled hypertension and worse renal function. Renal arteriogram revealed RRA stent fracture with in-stent restenosis. Another stent was deployed. Four months later, however, renal arteriogram revealed in-stent restenosis again. This time, balloon angioplasty alone was performed. He had been symptom-free with stable condition at 2-year follow-up. A literature review disclosed six renal artery stent fracture cases, including the present one, who developed in-stent stenosis resulted from stent fracture. Two major anatomy features of renal artery stenosis were suggestive for development of stent fracture: (1) renal artery entrapment by diaphragmatic crus, and (2) mobile kidney with acute angulation at proximal segment of the renal artery. It is important to detect this etiology of renal artery stenosis because stenting in these vessels may contribute to in-stent restenosis or stent fracture. Management of renal artery stent fracture, including endovascular treatment or aortorenal bypass, should be considered on a case-by-case basis in relation to clinical settings. Copyright 2009 Wiley-Liss, Inc.

Incidence and mechanisms of longitudinal stent deformation associated with Biomatrix, Resolute, Element, and Xience stents: Angiographic and case-by-case review of 1,800 PCIs.

PubMed

Arnous, Samer; Shakhshir, Nizar; Wiper, Andrew; Ordoubadi, Farzin-Farth; Williams, Paul; Clarke, Bernard; Mahadavan, Vaikom; El-Omar, Magdi; Mamas, Mamas; Fraser, Douglas

2015-11-15

There is conflicting evidence regarding the incidence of longitudinal stent deformation (LSD) in contemporary practice. To assess the incidence and mechanism of LSD across commonly used DES platforms, we performed a case-by-case review of 1,800 PCI cases involving 450 consecutive procedures using Biomatrix Flex, Resolute Integrity, Promus Element, and Xience V stents, respectively, between January 2009 and December 2011. LSD was detected in a higher proportion with Promus Element [15 (3.1%)] compared with other platforms (Xience V [4 (0.9%)], Biomatrix [3 (0.7%)], Resolute [3 (0.7%)]; P = 0.002). LSD was characterized as guide catheter/guide extension induced, or as impact from secondary devices such as postdilatation balloons or IVUS catheters. The incidence of guide catheter/guide extension LSD was similar across platforms; (Promus Element [5 (1.1%)], Xience V [4 (0.9%)], Biomatrix [3 (0.7%)], Resolute [3 (0.7%)]; P = 0.85). Secondary device LSD occurred exclusively with Promus Element (9/450 cases [2%] (P < 0.0001). Re-entering the deformed stent was more difficult in cases of secondary device LSD (6/9 compared with 0/12 treated cases; P < 0.001). Univariate predictors of LSD were previous CABG, culprit vessel, ostial involvement, and lesion tortuosity. Multivariate predictors of LSD were the Promus Element stent (OR 5.53 CI[1.54-19.85]), Guideliner use (OR 22.09 CI[4.73-103]), postdilation balloons (OR 5.47 CI[1.31-22.81]) and number of stents deployed (OR 2.06 CI[1.45-2.9]. LSD is more common than previously reported. LSD by a guide catheter/guide extension occurred equally with all platforms, however, LSD associated with secondary devices only occurred with the Element stent. These findings have important implications regarding current and future stent designs. © 2015 Wiley Periodicals, Inc.

Primary Self-Expandable Nitinol Stent Placement in Focal Lesions of Infrarenal Abdominal Aorta: Long Term Results

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lastovickova, Jarmila, E-mail: jala@medicon.cz; Peregrin, Jan H.

Purpose. To evaluate the technical and clinical success, safety and long term results of percutaneous transluminal angioplasty/self-expandable nitinol stent placement of infrarenal abdominal aorta focal lesions. Materials and Methods. Eighteen patients underwent PTA of focal atherosclerotic occlusive disease of distal abdominal aorta. Two symptomatic occlusions and 16 stenoses in 10 male and 8 female patients (mean age 68.2 years) were treated with primary self-expandable nitinol stent placement. Results. Primary self-expandable nitinol stent placement was technically successful in all 18 procedures; clinical success was achieved in 100% of patients. No complications associated with the procedure occurred. During the 49.4 months ofmore » mean follow up (range 3-96, 4 months) all treated aortic segments remained patent. Conclusions. Endovascular treatment (primary self-expandable nitinol stent placement) of focal atherosclerotic lesions of distal abdominal aorta is a safe method with excellent primary technical and clinical success rates and favourable Long term results.« less

Biliary intraductal metastasis from advanced gastric cancer: radiologic and histologic characteristics, and clinical outcomes of percutaneous metallic stent placement.

PubMed

Lee, JooYeon; Gwon, Dong Il; Ko, Gi-Young; Kim, Jong Woo; Sung, Kyu-Bo

2016-06-01

To investigate the radiologic and histological characteristics of biliary intraductal metastasis of advanced gastric cancer and the clinical outcomes of percutaneous, metallic stent placement. We retrospectively assessed 24 patients with obstructive jaundice related to biliary intraductal metastasis of gastric cancers who underwent PTBD and subsequent metallic stent placement between 2003 and 2012. Intraductal metastases appeared as uniform, concentric, linear (n = 17) or band-like (n = 7), enhanced wall thickening on CT, and 20 patients (83.3 %) had cystic ductal lesions. On pathology specimens, malignant cells scattered in the submucosal layer caused a desmoplastic reaction. The technical and clinical success rate of stent placement was achieved in all 24 patients. The median survival time was 203 days. Stent occlusion was observed in four patients with 49-278 days following stent placement. The median stent patency time was 156 days. The radiologic and histological characteristics of biliary intraductal metastasis of advanced gastric cancer consist of uniform, linear or band-like, enhanced biliary wall thickening and malignant cells scattered in the submucosal layer, together with the desmoplastic reaction without any disruption of the epithelial layer. Uncovered metallic stent placement was also a safe and effective method of palliative treatment in these patients. • The CT findings of intraductal metastasis were linear/band-like, enhanced biliary wall thickening. • The histological finding was malignant cells scattered in the submucosal layer. • It showed a desmoplastic reaction without any disruption of the epithelial layer. • Uncovered metallic stent placement was a safe and effective palliative treatment.

In vivo evaluation of a new bioabsorbable self-expanding biliary stent.

PubMed

Ginsberg, Gregory; Cope, Constantin; Shah, Janak; Martin, Tanisha; Carty, Anthony; Habecker, Perry; Kaufmann, Carol; Clerc, Claude; Nuutinen, Juha-Pekka; Törmälä, Pertti

2003-11-01

Bioabsorbable stents may offer advantages for the treatment of benign and malignant biliary strictures, including large stent diameter, decreased biofilm accumulation and proliferative changes, elimination of the need for stent removal and imaging artifacts, and prospects for drug impregnation. However, suboptimal expansion has hampered prior iterations. A new bioabsorbable biliary stent (BioStent) was evaluated in a porcine model. BioStents were placed in 8 animals for long-term follow-up. The following were evaluated: accuracy and ease of delivery and deployment, radial expansion, and radiologic visualization. Stent function and biotolerance were assessed by cholangiography, serum bilirubin, and necropsy for histopathology performed in pairs at 2, 4, 6, and 12 months. Stents were delivered without sphincterotomy and were deployed easily, accurately, and with good immediate stent expansion and radiographic visualization. On follow-up, all stents were fully expanded and serum bilirubin levels remained within the normal range. Although there was no clinical evidence of biliary obstruction, filling defects were common at cholangiography. On histopathologic evaluation, there was neither bile duct integration or proliferative change. The BioStent bioabsorbable biliary stent, modified with axial runners, can be effectively deployed endoscopically, is self-expanding, is visualized radiographically, and remains patent up to 6 months. There was no bile duct integration or proliferative change, which are potential advantages. Stent occlusion and migration remain concerns.

Endovascular techniques in limb salvage: cutting, cryo, brachy, and drug-eluting balloons.

PubMed

Davies, Mark G; Anaya-Ayala, Javier E

2013-04-01

The complex pathophysiology response to injury of the lower-extremity arteries has prompted the development of several unique balloon technologies to overcome initial technical failures and short-term intimal hyperplasia. Cryoplasty alters the cellular and mechanical properties of the vessel wall during angioplasty. Cutting balloons incise the wall, preventing elastic recoil and allowing expansion of the lumen at a lower pressure, thus limiting barotrauma. Drug-eluting balloons actively transfer inhibitory compounds to the wall during the initial therapy, while brachytherapy balloons allow for localized delivery of radiation to inhibit the proliferative response seen after angioplasty. These platforms provide unique means to enhance immediate and short-term results and also reduce stent usage in the lower extremity.

Successful percutaneous treatment of gluteal claudication secondary to isolated bilateral hypogastric stenoses.

PubMed

Chaer, Rabih A; Faries, Peter L; Lin, Stephanie; Dayal, Rajeev; McKinsey, James F; Kent, K Craig

2006-01-01

We report an unusual case of bilateral buttock claudication at ambulation of less than two blocks in a 57-year-old man with normal lower-extremity segmental pressure on noninvasive exercise testing. He was found to have bilateral high-grade internal iliac artery stenoses on arteriography. Both sides were successfully treated in a staged fashion via a contralateral approach with percutaneous transluminal angioplasty and a balloon-expandable stent, with complete symptom resolution. A clinical vascular examination with normal findings of the common iliac, external iliac, and common and superficial femoral arteries eliminates significant vascular obstruction as a cause of claudication. However, internal iliac occlusive disease may be suspected when symptoms are limited to the gluteal musculature and other causes are eliminated. Percutaneous interventions can be of diagnostic and therapeutic value.

[Brief history of percutaneous coronary intervention].

PubMed

Song, Zhi-yuan; Zhang, Zhi-ying; Xu, Ze-sheng

2010-05-01

Percutaneous coronary intervention (PCI) is that delivering balloon catheter and/or equipment such as a stent to the target coronary artery bypass peripheral artery, at the same time, expanding and opening the stenosis of coronary artery. Through several decades of development, PCI has become a most effective way to rescue patients with coronary heart disease and become one of the biggest advances in the field of heart disease. Because of the development of PCI, more lives have been saved in patients with coronary heart disease. However, PCI does not meet the point of perfection, still has a lot of issues remain to be further resolved. Through a review the development of PCI, we may be able to get some insights to perfect the treatment technique for the patients of coronary heart disease.

From debulking to delivery: sequential use of rotational atherectomy and Guidezilla™ for complex saphenous vein grafts intervention.

PubMed

Pellicano, Mariano; Floré, Vincent; Barbato, Emanuele; De Bruyne, Bernard

2018-06-19

Percutaneous coronary interventions (PCI) of old calcified saphenous vein grafts (SVGs) is challenging and is associated with a considerably high risk of adverse ischemic events in the short- and long-term as compared to native coronary arteries. We report a case in which a non-dilatable, calcified SVG lesion is successfully treated with rotational atherectomy followed by PCI and stenting with local stent delivery (LSD) technique using the Guidezilla™ guide extension catheter (5-in-6 Fr) in the "child-in-mother" fashion. A 70 years-old man with a dilated ischemic cardiomyopathy, triple coronary artery bypass grafting (CABG) in 1990 and chronic renal failure (baseline GFR: 45 ml/min/1.73 m 2 ) underwent a coronary angiography for a Non-ST segment elevation myocardial infarction (NSTEMI). Native coronary circulation was completely occluded at the proximal segments. Grafts angiography showed a tandem calcified lesions of SVG on distal right coronary artery (RCA) and an ostial stenosis of the SVG on first obtuse marginal branch (OM1). Left internal mammary artery on the mid left anterior descending artery was patent. Ad Hoc PCI of SVG on RCA was attempted. The proximal calcified stenosis has been crossed with a 1.5 x 12 mm balloon only with the support of Guidezilla™, however the non-compliant (NC) balloon 2.5 x 15 mm was unable to break the hard and calcified plaque. After several attempts, the procedure was interrupted with a suboptimal result. An elective transradial PCI of SVG on RCA with rotational atherectomy was performed. Two runs with 1.25 mm burr and 2 runs with 1.5 mm burr were carried out. Then, the use of distal anchoring balloon warranted support and tracking, made as centring rail for the advance of the tip of the "mother-and-child" catheter into the SVG. During slow deflation of the balloon, the Guidezilla™ was advanced distal to the stenoses to be stented, thus allowing the placement of two long drug eluting stents according to a LSD technique. Rotational atherectomy is a feasible option for non-dilatable stenoses in old SVGs when there is no evidence of thrombus or vessel dissection and the subsequent use of "mother-and-child" catheter has a key role, especially in case of radial approach, for long stents delivery.

Clinical Outcomes of Self-Expandable Metal Stents for Malignant Rectal Obstruction.

PubMed

Lee, Hyun Jung; Hong, Sung Pil; Cheon, Jae Hee; Kim, Tae Il; Kim, Won Ho; Park, Soo Jung

2018-01-01

Self-expandable metal stents are widely used to treat malignant colorectal obstruction. However, data on clinical outcomes of stent placement for rectal obstruction specifically are lacking. We aimed to investigate the clinical outcomes of self-expandable metal stents in malignant rectal obstruction in comparison with those in left colonic obstruction and to identify factors associated with clinical failure and complication. This was a retrospective study. The study was conducted at a tertiary care center. Between January 2005 and December 2013, medical charts of patients who underwent stent placement for malignant rectal or left colonic obstruction were reviewed retrospectively. Study intervention included self-expandable metal stent placement. Technical success, clinical success, and complications were measured. Technical success rates for the 2 study groups (rectum vs left colon, 93.5% vs 93.1%; p = 0.86) did not differ significantly; however, the clinical success rate was lower in patients with rectal obstruction (85.4% vs 92.1%; p = 0.02). In addition, the complication rate was higher in patients with rectal obstruction (37.4% vs 25.1%; p = 0.01). Patients with rectal obstruction showed higher rates of obstruction because of extracolonic malignancy (33.8% vs 15.8%; p < 0.001) and stent use for palliation (78.6% vs 56.3%; p < 0.001). Multivariate analysis indicated obstruction attributed to extracolonic malignancy and covered stent usage to be independent risk factors for clinical failure. Factors predictive of complications in the palliative group were total obstruction, obstruction because of extracolonic malignancy, and covered stent usage. This was a retrospective, single-center study. The efficacy and safety of stent placement for malignant rectal obstruction were comparable with those for left colonic obstruction. However, obstruction attributed to extracolonic malignancy, use of covered stents, and total obstruction negatively impacted clinical outcomes of self-expandable metal stent placement and must be considered by endoscopists. See Video Abstract at http://links.lww.com/DCR/A417.

Plastic vs. Self-Expandable Metal Stents for Palliation in Malignant Biliary Obstruction: A Series of Meta-Analyses.

PubMed

Almadi, Majid A; Barkun, Alan; Martel, Myriam

2017-02-01

Self-expandable metal stents (SEMS) are thought to have an advantage over plastic stents in achieving biliary drainage. We performed a systematic search of MEDLINE, EMBASE, Scopus, CENTRAL, and ISI Web of knowledge databases, from January 1980 to September 2015, for randomized-controlled trials (RCTs) comparing SEMS vs. plastic stents in the palliation of malignant biliary obstruction. Primary outcomes were durations of stent patency, patient survival, and 30-day mortality. Numerous secondary outcomes were assessed, and extensive sensitivity and subgroup analyses were performed. In all, 20 RCTs totaling 1,713 patients yielded a weighted mean difference (WMD) in time to stent patency (4 studies) of 4.45 months (95% confidence interval (CI), 0.31, 8.59; GRADE=moderate) favoring SEMS. There were no differences in overall patient survival (5 studies) WMD=0.67 months (95% CI, -0.66, 1.99; GRADE=moderate), or 30-day mortality (8 studies) odds ratio (OR)=0.80 (95% CI, 0.52, 1.24; GRADE=moderate) but there was a higher symptom-free survival at 6 months (4 studies) OR=5.96 (95% CI, 1.71, 20.81; GRADE=moderate). SEMS use resulted in lower rates of late complications (11 studies) OR=0.43 (95% CI, 0.26, 0.71; GRADE=moderate), sepsis or cholangitis (14 studies) OR=0.53 (95% CI, 0.37, 0.77; GRADE=high), blocking from sludge (8 studies) OR=0.11(95% CI, 0.07, 0.17; GRADE=moderate), and mean number of re-interventions (8 studies) WMD=-0.83 interventions (95% CI, -1.64, -0.02; GRADE=moderate). There was a longer patency of SEMS for those without a prior drainage attempt (2 studies) WMD 7.70 months (95% CI, 7.14, 8.25; GRADE=high). Although a survival advantage was found when an uncovered SEMS was used (3 studies) WMD 1.31 months (95% CI, 0.30, 2.32; GRADE=high), but not partially or fully covered SEMS (2 studies) WMD -0.66 months (95% CI, -1.02, -0.30; GRADE=high) vs. plastic stents, and for SEMS in the setting of pre- or post-procedural antibiotic administration (2 studies) WMD 1.49 months (95% CI, 0.27, 2.70; GRADE=high), and performance of a sphincterotomy (2 studies) WMD 1.63 months (95% CI, 0.42, 2.84; GRADE=high). Keeping in mind the noted risk of bias in source data, the use of SEMS compared with plastic stents, in the palliation of patients with malignant biliary obstruction results in longer stent patency, lower complications rates, and fewer re-interventions, whereas exhibiting survival benefits in selected subgroups of patients.

Comparison of the endothelial coverage in everolimus and zotarolimus-eluting stents in normal, atherosclerotic, and bifurcation rabbit iliac arteries.

PubMed

Torii, Sho; Nakazawa, Gaku; Ijichi, Takeshi; Yoshikawa, Ayako; Ohno, Yohei; Ikari, Yuji

2018-01-01

The aim of this study is to evaluate differences in stent endothelial coverage among the second generation of drug-eluting stents. Incomplete stent coverage is one of the major causes of late stent thrombosis. Rabbits fed a normal diet received an everolimus (Xience Prime; EES) and a zotarolimus-eluting stent (Resolute Integrity; R-ZES) in each iliac artery, followed by sacrifice at 14 and 28 days after stent implantation. In addition, a group of atherosclerotic rabbits similarly received EES and R-ZES, and were sacrificed at 28 days. The extent of stent endothelial coverage was assessed by scanning electron microscopy. To evaluate endothelial coverage after bifurcation stenting, rabbits received EES and R-ZES placed with culotte stenting at the iliac bifurcation, followed by sacrifice at 14 and 28 days. In rabbits fed a normal diet, the percent uncovered strut area 14 days after stent implantation was significantly higher in R-ZES than in EES (10.1% (IQR 9.8-15.5) vs. 3.0% (IQR 1.5-9.7), p = 0.03), whereas it was not significantly different at 28-days (3.9% (IQR 0.8-10.3) vs. 1.0% (IQR 0.0-2.8), p = 0.2). In rabbits with induced atheroma, R-ZES also showed less endothelial coverage 28 days after stent implantation (5.3% (IQR 2.2-9.9) vs. 1.1% (IQR 0-6.2), p = 0.03). In the culotte stenting model, the percent uncovered strut area of the proximal overlapped segment was significantly higher in R-ZES at 14 days (15.8% (IQR 14.3-17.7) vs. 8.8% (IQR 8.3-9.8), p = 0.03) and 28 days (9.9% (IQR 4.1-13.9) vs. 2.5% (IQR 1.6-6.7), p = 0.04) after stent implantation. The carina area also showed a better coverage in EES compared with R-ZES. EES showed a better stent endothelial coverage compared with R-ZES after stent implantation in the early phase in normals, in arteries with lipid rich plaque, and in bifurcation stented sites.

Self-Expandable Metallic Stent Placement for the Palliation of Esophageal Cancer.

PubMed

Kim, Kun Yung; Tsauo, Jiaywei; Song, Ho Young; Kim, Pyeong Hwa; Park, Jung Hoon

2017-07-01

Esophageal stents have been used to palliate patients with dysphagia caused by esophageal cancer. Early rigid plastic prostheses have been associated with a high risk of complications. However, with the development of self-expanding stents, it has developed into a widely accepted method for treating malignant esophageal strictures and esophagorespiratory fistulas (ERFs). The present review covers various aspects of self-expanding metallic stent placement for palliating esophageal cancer, including its types, placement procedures, indications, contraindications, complications, and some of innovations that will become available in the future. © 2017 The Korean Academy of Medical Sciences.

[Cost-effectiveness trial of self-expandable metal stents and plastic biliary stents in malignant biliary obstruction].

PubMed

Daróczi, Tímea; Bor, Renáta; Fábián, Anna; Szabó, Ella; Farkas, Klaudia; Bálint, Anita; Czakó, László; Rutka, Mariann; Szűcs, Mónika; Milassin, Ágnes; Molnár, Tamás; Szepes, Zoltán

2016-02-14

Self-expandable metal and plastic stents can be applied in the palliative endoscopic treatment of patients with unresectable malignant biliary obstruction. The use of metal stentsis recommended if the patient's life expectancy is more than four months. To compare the therapeutic efficacy and cost-effectiveness of metal and plastic stents in the treatment of malignant biliary obstruction. The authors retrospectively enrolled patients who received metal (37 patients) or plastic stent (37 patients). The complication rate, stent patency and cumulative cost of treatment were assessed in the two groups. The complication rate of metal stents was lower (37.84% vs. 56.76%), but the stent patency was higher compared with plastic stents (19.11 vs. 8.29 weeks; p = 0.0041). In the plastic stent group the frequency of hospitalization of patients in context with stent complications (1.18 vs. 2.32; p = 0.05) and the necessity of reintervention for stent dysfunction (17 vs. 27; p = 0.033) were substantially higher. In this group multiple stent implantation raised the stent patency from 7.68 to 10.75 weeks. There was no difference in the total cost of treatment of malignant biliary obstruction between the two groups (p = 0.848). Considering the cost of treatment and the burden of patients the authors recommend self-expandable metal sten timplantation if the life expectancy of patients is more than two months. In short survival cases multiple plastic stent implantation is recommended.

Anesthesia and airway management for removing pulmonary self-expanding metallic stents.

PubMed

Doyle, D John; Abdelmalak, Basem; Machuzak, Michael; Gildea, Thomas R

2009-11-01

The use of bronchoscopically placed self-expanding metallic stents (SEMS) and silastic stents in patients suffering from tracheobronchial stenosis or similar problems has proven to be an important clinical option. When complications occur, it may be necessary to remove the device. Removal of a SEMS is usually performed during general anesthesia with muscle relaxation and positive pressure ventilation, often using total intravenous anesthesia. Airway management depends on stent type and location. Intubating patients' tracheas with a tracheal stent requires special caution, as it risks damaging tissue and dislodging the stent distally. Potential complications with removal include tracheal disruption, retained stent pieces, mucosal tears, re-obstruction requiring new stent placement, the need for postoperative ventilation, pneumothorax, damage to the pulmonary artery, and death.

Y-shaped bilateral self-expandable metallic stent placement for malignant hilar biliary obstruction: data from a referral center for palliative care.

PubMed

Di Mitri, R; Mocciaro, F

2014-01-01

Malignant hilar strictures are a clinical challenge because of the current therapeutic approach and the poor prognosis. In recent years, self-expandable metallic stents have proven more effective than plastic stents for palliation of malignant hilar strictures, with the bilateral stent-in-stent technique registering a high success rate. We report our experience with Y-shaped endoscopic self-expandable metallic stents placement for treatment of advanced malignant hilar strictures. From April 2009 to August 2012, we prospectively collected data on patients treated with Y-shaped SEMS placement for advanced malignant hilar carcinoma. Data on technical success, clinical success, and complications were collected. Twenty patients (9 males) were treated (mean age 64.2 ± 15.3 years). The grade of malignant hilar strictures according to the Bismuth classification was II in 5 patients (25%), IIIa in 1 (5%), and IV in 14 (70%). The mean bilirubin level was 14.7 ± 4.9 mg/dL. Technical success was achieved in all patients, with a significant reduction in bilirubin levels (2.9 ± 1.7 mg/dL). One patient experienced cholangitis as early complication, while in 2 patients stent ingrowth was observed. No stents migration was recorded. There was no procedure-related mortality. At the end of the follow-up (7.1 ± 3.1 months), 13 of the 20 patients (65%) had died. Our experience confirms endoscopic bilateral self-expandable metallic stents placement with stent-in-stent technique (Y-shaped configuration) as a feasible, effective, and safe procedure for palliation of unresectable malignant hilar strictures.

Finite Element Analysis of the Implantation Process of Overlapping Stents

PubMed Central

Xu, Jiang; Yang, Jie; Sohrabi, Salman; Zhou, Yihua; Liu, Yaling

2017-01-01

Overlapping stents are widely used in vascular stent surgeries. However, the rate of stent fractures (SF) and in-stent restenosis (ISR) after using overlapping stents is higher than that of single stent implantations. Published studies investigating the nature of overlapping stents rely primarily on medical images, which can only reveal the effect of the surgery without providing insights into how stent overlap influences the implantation process. In this paper, a finite element analysis of the overlapping stent implantation process was performed to study the interaction between overlapping stents. Four different cases, based on three typical stent overlap modes and two classical balloons, were investigated. The results showed that overlapping contact patterns among struts were edge-to-edge, edge-to-surface, and noncontact. These were mainly induced by the nonuniform deformation of the stent in the radial direction and stent tubular structures. Meanwhile, the results also revealed that the contact pressure was concentrated in the edge of overlapping struts. During the stent overlap process, the contact pattern was primarily edge-to-edge contact at the beginning and edge-to-surface contact as the contact pressure increased. The interactions between overlapping stents suggest that the failure of overlapping stents frequently occurs along stent edges, which agrees with the previous experimental research regarding the safety of overlapping stents. This paper also provides a fundamental understanding of the mechanical properties of overlapping stents. PMID:28690712

Self-expandable metal stents for malignant colonic obstruction: data from a retrospective regional SIED-AIGO study.

PubMed

Di Mitri, Roberto; Mocciaro, Filippo; Traina, Mario; Montalbano, Luigi Maria; Familiari, Luigi; D'Amore, Fabio; Raimondo, Dario; Virgilio, Clara; Tarantino, Ilaria; Barresi, Luca; Giunta, Marco; Borina, Eleonora; Borruto, Antonino; Marino, Antonino

2014-03-01

Self-expandable metal stents are a non-surgical option for the treatment of symptomatic malignant colorectal obstruction as palliative treatment or as a bridge to surgery. To report data from a regional study on self-expandable metal stent (SEMS) placement for malignant colorectal obstruction. Two hundred and four patients (male 54.9%, mean age of 69.5 ± 14.2) were retrospectively evaluated and data on technical and clinical success, and complications, were analyzed. Technical and clinical success rates were 99% and 94.6% respectively, with 36.7% treated on an emergency basis and 63.3% electively. Palliative treatment was administered to 70.1%, and as a bridge to surgery for 29.9%. Complications were 17 neoplastic ingrowths, 10 stent migrations, and 4 perforations. Palliative treatment was associated with a higher risk of stent ingrowth (p=0.003), and chemotherapy with a lower risk of stent ingrowth (p=0.009). This regional study, although it has certain limitations, confirms the positive role of self-expandable metal stents in the treatment of symptomatic malignant colorectal obstruction, and that chemotherapy decreases the risk of ingrowth. Copyright © 2013 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

Placement of retrievable self-expandable metallic stents with barbs into patients with obstructive prostate cancer.

PubMed

Song, Ho-Young; Kim, Choung Soo; Jeong, In Gab; Yoo, Dalsan; Kim, Jin Hyoung; Nam, Deok Ho; Bae, Jae-Ik; Park, Jung-Hoon

2013-03-01

To evaluate the technical feasibility and clinical effectiveness of retrievable self-expandable metallic stents with barbs in patients with obstructive prostate cancer. Retrievable self-expandable metallic stents with eight barbs each were inserted into eight consecutive patients with obstructive prostate cancer. Patient ages ranged from 55 to 76 years (mean, 69 years). All eight patients had previously received hormone therapy, and three had undergone palliative transurethral prostatectomy. Stents were removed using a 21-F stent removal set if they caused complications. Stent placement was technically successful and well tolerated in all patients. One had severe incontinence, which improved spontaneously, and two had gross haematuria, which disappeared spontaneously within 4 days. Peak urine flow rates and post-void residual urine volumes 1 month after stent placement were 5.6-10.2 ml/s (mean, 8.3 ml/s), and 5-45 ml (mean, 27 ml), respectively. During a mean follow-up of 192 days (range, 39-632 days), one patient required stent removal after 232 days because of stone formation within the stent. No further intervention was required because the mass improved after stent removal. These preliminary results suggest that retrievable stents with eight barbs are both feasible to place and effective in patients with obstructive prostate cancer.

Predictors of the patency of self-expandable metallic stents in malignant gastroduodenal obstruction

PubMed Central

Kim, Seung Han; Chun, Hoon Jai; Yoo, In Kyung; Lee, Jae Min; Nam, Seung Joo; Choi, Hyuk Soon; Kim, Eun Sun; Keum, Bora; Seo, Yeon Seok; Jeen, Yoon Tae; Lee, Hong Sik; Um, Soon Ho; Kim, Chang Duck

2015-01-01

AIM: To investigate the predictive factors of self-expandable metallic stent patency after stent placement in patients with inoperable malignant gastroduodenal obstruction. METHODS: A total of 116 patients underwent stent placements for inoperable malignant gastroduodenal obstruction at a tertiary academic center. Clinical success was defined as acceptable decompression of the obstructive lesion within the malignant gastroduodenal neoplasm. We evaluated patient comorbidities and clinical statuses using the World Health Organization’s scoring system and categorized patient responses to chemotherapy using the Response Evaluation Criteria in Solid Tumors criteria. We analyzed the relationships between possible predictive factors and stent patency. RESULTS: Self-expandable metallic stent placement was technically successful in all patients (100%), and the clinical success rate was 84.2%. In a multivariate Cox proportional hazards model, carcinoembryonic antigen (CEA) levels were correlated with a reduction in stent patency [P = 0.006; adjusted hazard ratio (aHR) = 2.92, 95%CI: 1.36-6.25]. Palliative chemotherapy was statistically associated with an increase in stent patency (P = 0.009; aHR = 0.27, 95%CI: 0.10-0.72). CONCLUSION: CEA levels can easily be measured at the time of stent placement and may help clinicians to predict stent patency and determine the appropriate stent procedure. PMID:26290640

Computer Simulation of the Mechanical Behaviour of Implanted Biodegradable Stents in a Remodelling Artery

NASA Astrophysics Data System (ADS)

Boland, Enda L.; Grogan, James A.; Conway, Claire; McHugh, Peter E.

2016-04-01

Coronary stents have revolutionised the treatment of coronary artery disease. While coronary artery stenting is now relatively mature, significant scientific and technological challenges still remain. One of the most fertile technological growth areas is biodegradable stents; here, there is the possibility to generate stents that will break down in the body once the initial necessary scaffolding period is past (6-12 months) (Grogan et al. in Acta Biomater 7:3523, 2011) and when the artery has remodelled (including the formation of neo-intima). A stent angioplasty computational test-bed has been developed by the authors, based on the Abaqus software (DS-SIMULIA, USA), capable of simulating stent tracking, balloon expansion, recoil and in vivo loading in a atherosclerotic artery model. Additionally, a surface corrosion model to simulate uniform and pitting corrosion of biodegradable stents and a representation of the active response of the arterial tissue following stent implantation, i.e. neointimal remodelling, has been developed. The arterial neointimal remodelling simulations with biodegradable stent corrosion demonstrate that the development of new arterial tissue around the stent struts has a substantial effect on the mechanical behaviour of degrading stents.

Results From the VISIBILITY Iliac Study: Primary and Cohort Outcomes at 9 Months

PubMed Central

Rundback, John H.; Peeters, Patrick; George, Jon C.; Jaff, Michael R.; Faries, Peter L.

2017-01-01

Purpose: To evaluate the safety and effectiveness of primary stenting of the common (CIA) or external iliac artery (EIA) using the Visi-Pro Balloon-Expandable Peripheral Stent System for treatment of stenotic, restenotic, or occluded lesions. Methods: Between 2011 and 2012, 75 patients (mean age 64.2±8.9 years; 46 men) with Rutherford category 2–4 ischemia and atherosclerotic lesions ≤10 cm in length underwent iliac artery stenting at 17 centers in the United States and Europe. The primary outcome of the study was the major adverse event (MAE) rate at 9 months postprocedure [composite of periprocedural death, in-hospital myocardial infarction, clinically driven target lesion revascularization (CD-TLR), and amputation of the treated limb]. Secondary outcomes included 30-day MAE rate, 9-month primary patency, changes in ankle-brachial index (ABI) and the Walking Impairment Questionnaire at 30 days and 9 months postprocedure, device success, and clinically driven target vessel revascularization (CD-TVR) at 30 days and 9 months. Outcomes in specific patient cohorts (ie, gender, stent location, calcification severity, and lesion grade) were analyzed. Results: Eighty-one stents were implanted in 61 CIA and 15 EIA lesions (41 with moderate/severe calcification). The mean lesion treated length was 29.3±13.9 mm. All devices were successfully deployed. MAE occurred in 3 (4.0%) of 75 subjects at 9 months. Primary patency and freedom from CD-TVR at 9 months were both 95.8%. ABI improved from 0.67±0.14 at baseline to 0.94±0.14 and 0.96±0.16 at 30 days and 9-month follow-up, respectively (p<0.001 for both). There were no differences with respect to any of the analyzed patient characteristics, including gender. Conclusion: Nine-month results of the VISIBILITY Iliac stent study (ClinicalTrials.gov identifier NCT01402700) demonstrated safety and effectiveness for the treatment of atherosclerotic CIA and EIA lesions with the Visi-Pro stent across all treated cohorts. PMID:28351204

Fully covered self-expandable metal stents (SEMS), partially covered SEMS and self-expandable plastic stents for the treatment of benign esophageal ruptures and anastomotic leaks

PubMed Central

2012-01-01

Background Benign esophageal ruptures and anastomotic leaks are life-threatening conditions that are often treated surgically. Recently, placement of partially and fully covered metal or plastic stents has emerged as a minimally invasive treatment option. We aimed to determine the clinical effectiveness of covered stent placement for the treatment of esophageal ruptures and anastomotic leaks with special emphasis on different stent designs. Methods Consecutive patients who underwent placement of a fully covered self-expandable metal stent (FSEMS), a partially covered SEMS (PSEMS) or a self-expanding plastic stent (SEPS) for a benign esophageal rupture or anastomotic leak after upper gastrointestinal surgery in the period 2007-2010 were included. Data on patient demographics, type of lesion, stent placement and removal, clinical success and complications were collected Results A total of 52 patients received 83 esophageal stents (61 PSEMS, 15 FSEMS, 7 SEPS) for an anastomotic leak (n = 32), iatrogenic rupture (n = 13), Boerhaave's syndrome (n = 4) or other cause (n = 3). Endoscopic stent removal was successful in all but eight patients treated with a PSEMS due to tissue ingrowth. Clinical success was achieved in 34 (76%, intention-to-treat: 65%) patients (PSEMS: 73%, FSEMS: 83%, SEPS: 83%) after a median of 1 (range 1-5) stent and a median stenting time of 39 (range 7-120) days. In total, 33 complications in 24 (46%) patients occurred (tissue in- or overgrowth (n = 8), stent migration (n = 10), ruptured stent cover (all Ultraflex; n = 6), food obstruction (n = 3), severe pain (n = 2), esophageal rupture (n = 2), hemorrhage (n = 2)). One (2%) patient died of a stent-related cause. Conclusions Covered stents placed for a period of 5-6 weeks may well be an alternative to surgery for treating benign esophageal ruptures or anastomotic leaks. As efficacy between PSEMS, FSEMS and SEPS is not different, stent choice should depend on expected risks of stent migration (SEPS and FSEMS) and tissue in- or overgrowth (PSEMS). PMID:22375711

[Macroscopic hematuria secondary to nutcracker syndrome and successful endovascular treatment].

PubMed

Hinojosa, Carlos A; Anaya-Ayala, Javier E; Boyer-Duck, Estefanía; Laparra-Escareno, Hugo; Torres-Machorro, Adriana; Lizola, Rene

2017-12-01

Nutcracker syndrome is a rare entity, and in the majority of cases is the result of extrinsic compression of the left renal vein between the superior mesenteric artery and the aorta, associated with functional stenosis. To present the case of a 19-year-old female with no significant medical history with confirmed diagnosed of nutcracker syndrome treated successfully by endovascular means. She was referred to the Vascular Surgery Department with a 6-month history of macroscopic haematuria, after other aetiologies were ruled out. Abdominal computed tomography angiography revealed compression of the left renal vein; the patient underwent endovascular treatment, and a 12×16 mm balloon expandable stent was placed with immediate angiographic improvement, decreased pressure gradients and progressive resolution of haematuria. At one year, she remains symptom-free. Nutcracker syndrome is uncommon, and a high index of suspicion is needed. Macroscopic haematuria is not always present, and in our case stent placement demonstrated effectiveness in the resolution of symptoms at 12 months' follow--up. We also present a brief review of the literature. Copyright © 2016 Academia Mexicana de Cirugía A.C. Publicado por Masson Doyma México S.A. All rights reserved.

Thirty-Day Outcome Following Carotid Artery Stenting: A 10-Year Experience from a Single Center

DOE Office of Scientific and Technical Information (OSTI.GOV)

Karkos, Christos D., E-mail: ckarkos@hotmail.com; Karamanos, Dimitrios G.; Papazoglou, Konstantinos O.

2010-02-15

We aimed to present our experience with carotid angioplasty and stenting (CAS) and to document how the technique evolved over the last decade (1997-2007). A retrospective study of 333 patients (259 men; median age, 69 years) who underwent 336 CAS procedures. Of these, 118 (35%) patients were symptomatic and 164 (49%) lesions involved the left carotid bifurcation. The first 163 patients received a balloon-expandable stent, whereas the remaining 173 received a self-expandable one. Cerebral protection devices were used in the last 84 (25%) procedures. Access was via the femoral artery in all but six cases, in which direct puncture ofmore » the common carotid was necessary. The left common carotid originated from the innominate artery in 18 cases (5%). Conversion to open endarterectomy was necessary in two patients due to inability to remove the filter. Perioperative neurological events included stroke in 6 patients (1.8%), transient ischemic attack in 15 (4.5%), and hyperperfusion syndrome in 10 (3.0%). Three patients died during the first 30 days. As a result, the mortality and the combined stroke/death rate were 0.9 and 2.4%, respectively, with no differences between symptomatic and asymptomatic patients. Bradycardia was noted in 48 patients (14%), and hypotension in 45 (13%). Univariate analysis identified hypertension (P = 0.03), hyperlipidemia (P = 0.02), and current or ex-smoking (P = 0.02) as significant risk factors for death/stroke. On multivariate analysis using logistic regression, only hyperlipidemia [odds ratio (OR), 53.90; 95% confidence interval (CI), 4.19-693.47; P = 0.002] and current or ex-smoking (OR, 63.84; 95% CI,: 4.80-848.68; P = 0.001) remained statistically significant. In conclusion, CAS can be performed safely and effectively, with acceptable mortality, stroke/death, and cardiovascular complication rates. Although technological advances (stent design, cerebral protection devices), perioperative pharmacological management, and increasing experience are all clinically significant factors influencing the short-term results, none appeared to be statistically significant in this patient sample.« less

Robot-assisted antegrade in-situ fenestrated stent grafting.

PubMed

Riga, Celia V; Bicknell, Colin D; Wallace, Daniel; Hamady, Mohamad; Cheshire, Nicholas

2009-05-01

To determine the technical feasibility of a novel approach of in-situ fenestration of aortic stent grafts by using a remotely controlled robotic steerable catheter system in the porcine model. A 65-kg pig underwent robot-assisted bilateral antegrade in-situ renal fenestration of an abdominal aortic stent graft with subsequent successful deployment of a bare metal stent into the right renal artery. A 16-mm iliac extension covered stent served as the porcine aortic endograft. Under fluoroscopic guidance, the graft was punctured with a 20-G customized diathermy needle that was introduced and kept in place by the robotic arm. The needle was exchanged for a 4 x 20 mm cutting balloon before successful deployment of the renal stent. Robot-assisted antegrade in-situ fenestration is technically feasible in a large mammalian model. The robotic system enables precise manipulation, stable positioning, and minimum instrumentation of the aorta and its branches while minimizing radiation exposure.

Use of the Viatorr Expanded Polytetrafluoroethylene-Covered Stent-Graft for Transjugular Intrahepatic Portosystemic Shunt Creation in Children: Initial Clinical Experience

DOE Office of Scientific and Technical Information (OSTI.GOV)

Mermuys, Koen; Maleux, Geert, E-mail: geert.maleux@uzleuven.be; Heye, Sam

2008-07-15

Four children, three boys and one girl, with a median age of 9 years 8 months, underwent transjugular intrahepatic portosystemic shunt creation with an expanded polytetrafluoroethylene (e-PTFE)-covered nitinol stent. The stent-graft was successfully placed in all four patients without any complication. Clinical and biochemical improvement was noted in all four patients during follow-up. Radiological follow-up with use of duplex ultrasound showed a recurrent stenosis of the shunt 180 days after stent-graft implantation in one patient. This was treated with placement of an additional stent-graft, re-expanding completely the recurrent stenosis. In the other three patients, the stent-graft remained fully patent untilmore » the end of the study or until orthotopic liver transplantation. These preliminary results suggest that use of the Viatorr ePTFE-covered stent-graft in children is safe and feasible, with potentially the same high patency rate and improved clinical outcome as reported in adult patients.« less

Optical Coherence Tomography

MedlinePlus

... patients who undergo balloon angioplasty also receive a stent—a small mesh-like device placed inside the ... OCT images can help cardiologists see if a stent is holding an artery open and whether the ...

Novel intravascular ultrasound-guided method to create transintimal arterial communications: initial experience in peripheral occlusive disease and aortic dissection.

PubMed

Saket, Ramin R; Razavi, Mahmood K; Padidar, Arash; Kee, Stephen T; Sze, Daniel Y; Dake, Michael D

2004-06-01

To report our experience using a commercially available catheter-based system equipped with an intravascular ultrasound (IVUS) transducer to achieve controlled true lumen re-entry in patients undergoing subintimal angioplasty for chronic total occlusions (CTO) or aortic dissections. During an 8-month period, 10 patients (6 men; mean age 73.4 years) with lower extremity (LE) ischemia from CTOs (n=7) or true lumen collapse from aortic dissections (n=3) were treated. Subintimal access and controlled re-entry of the CTOs were performed with a commercially available 6.2-F dual-lumen catheter, which contained an integrated 64-element phased-array IVUS transducer and a deployable 24-G needle through which a guidewire was passed once the target lumen was reached. The occluded segments were balloon dilated; self-expanding nitinol stents were deployed. In the aortic dissections, fenestrations were performed using the same device, with the IVUS unit acting as the guide. The fenestrations were balloon dilated and stented to support the true lumen. Time to effective re-entry ranged from 6 to 10 minutes (mean 7) in the CTOs; antegrade flow was restored in all 7 CTOs, and the patients were free of ischemic symptoms at up to 8-month follow-up. In the aortic dissection cases, the fenestrations equalized pressures between the lumens and restored flow into the compromised vessels. There were no complications related to the use of this device in any of the 10 patients. Our preliminary results demonstrate the feasibility of using this catheter-based system for subintimal recanalization with controlled re-entry in CTOs and for aortic flap fenestrations in aortic dissections. This approach can improve the technical success rate, reduce the time of the procedure, and minimize potential complications.

Comparison of Temporary Open Arterial Revascularization Using Stent Grafts vs. Standard Vascular Shunts in a Porcine (Sus scrofa) Model

DTIC Science & Technology

2017-01-24

Objectives: Open surgical reconstruction using expanded polytetrafluoroethylene stent grafts to create a sutureless anastomosis is an alternative to...French Argyle shunt was inserted into one randomly assigned artery, with a self-expanding ePTFE stent deployed in the other. Arterial flow measurements...for histopathology were obtained during the terminal procedure. Results: Angiography revealed no difference in patency at 72 hours. The stent grafts

Treatment of tracheomalacia with Palmaz stent: a case report.

PubMed

Inan, Mustafa; Ayvaz, Süleyman; Basaran, Umit Nusret

2005-01-01

Tracheomalacia is a potentially life-threatening clinical problem. The expandable Palmaz stent can be used for the treatment of tracheomalacia. We describe a female infant with tracheomalacia who showed respiratory distress the day after birth. Tracheomalacia was diagnosed by bronchoscopic examination, computed tomography and bronchography. At 75 days of age, an expandable metallic stent (Palmaz stent) was inserted into the trachea under fluoroscopic control. The patient's respiratory status improved rapidly. Bronchoscopic examination 6 months after the insertion did not show any granulation tissue. However, in bronchoscopic examination carried out two years later, we detected invasion of the Palmaz stent to the trachea and development of granulation tissue. We think that expandable metallic stent placement should be considered in patients who show intractable respiratory symptoms caused by tracheomalacia in the earlier stages of the treatment. But long-term complications of this procedure are crucial.

Transtracheal single-point stent fixation in posttracheotomy tracheomalacia under cone-beam computer tomography guidance by transmural suturing with the Berci needle - a perspective on a new tool to avoid stent migration of Dumon stents.

PubMed

Hohenforst-Schmidt, Wolfgang; Linsmeier, Bernd; Zarogoulidis, Paul; Freitag, Lutz; Darwiche, Kaid; Browning, Robert; Turner, J Francis; Huang, Haidong; Li, Qiang; Vogl, Thomas; Zarogoulidis, Konstantinos; Brachmann, Johannes; Rittger, Harald

2015-01-01

Tracheomalacia or tracheobronchomalacia (TM or TBM) is a common problem especially for elderly patients often unfit for surgical techniques. Several surgical or minimally invasive techniques have already been described. Stenting is one option but in general long-time stenting is accompanied by a high complication rate. Stent removal is more difficult in case of self-expandable nitinol stents or metallic stents in general in comparison to silicone stents. The main disadvantage of silicone stents in comparison to uncovered metallic stents is migration and plugging. We compared the operation time and in particular the duration of a sufficient Dumon stent fixation with different techniques in a patient with severe posttracheotomy TM and strongly reduced mobility of the vocal cords due to Parkinson's disease. The combined approach with simultaneous Dumon stenting and endoluminal transtracheal externalized suture under cone-beam computer tomography guidance with the Berci needle was by far the fastest approach compared to a (not performed) surgical intervention, or even purely endoluminal suturing through the rigid bronchoscope. The duration of the endoluminal transtracheal externalized suture was between 5 minutes and 9 minutes with the Berci needle; the pure endoluminal approach needed 51 minutes. The alternative of tracheobronchoplasty was refused by the patient. In general, 180 minutes for this surgical approach is calculated. The costs of the different approaches are supposed to vary widely due to the fact that in Germany 1 minute in an operation room costs on average approximately 50-60€ inclusive of taxes. In our own hospital (tertiary level), it is nearly 30€ per minute in an operation room for a surgical approach. Calculating an additional 15 minutes for patient preparation and transfer to wake-up room, therefore a total duration inside the investigation room of 30 minutes, the cost per flexible bronchoscopy is per minute on average less than 6€. Although the Dumon stenting requires a set-up with more expensive anesthesiology accompaniment, which takes longer than a flexible investigation estimated at 1 hour in an operation room, still without calculation of the costs of the materials and specialized staff that the surgical approach would consume at least 3,000€ more than a minimally invasive approach performed with the Berci needle. This difference is due to the longer time of the surgical intervention which is calculated at approximately 180 minutes in comparison to the achieved non-surgical approach of 60 minutes in the operation suite.

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

PubMed

Na, Han Kyu; Song, Ho-Young; Kim, Jin Hyoung; Park, Jung-Hoon; Kang, Min Kyoung; Lee, Jongjin; Oh, Se Jin

2013-03-01

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

[The application of Y-shaped self-expandable covered metal stents in the thoracostomach-airway fistula: a single center, 11 years experience].

PubMed

Fang, Yi; Li, Tengfei; Han, Xinwei; Wu, Gang; Ren, Jianzhuang; Ren, Kewei; Lu, Huibin; Zhang, Quanhui; Li, Zongming

2015-08-01

To investigate the clinical feasibility and efficacy of Y-shaped self-expandable covered metal stents (Y-stents) in the management of thoracostomach-airway fistula. Retrospective analysis was performed for 108 patients treated for thoracostomach-airway fistula with Y-shaped self-expandable coated metal stents between April 2003 and October 2014. Y-stents were designed based on the dimensions of trachea and bronchus and sites of the fistula and then were inserted under DSA monitoring. There were 65 cases with single big Y-stent placement, 26 cases with single small Y-stent placement, 23 cases with double Y-stents placement, and 1 case with 3 Y-stents placement. Stent implantation was successfully accomplished with single manipulation in all patients. Complete occlusion of the fistula was obtained in 104 patients after the primary manipulation, and 4 patients required a secondary manipulation where a double Y-stents was inserted because of failure of primary manipulate. Ninety-two patients completed the follow-up , while 16 were lost. Fifty-nine patients died while 33 were alive with marked improvement in their quality of life. The placement of Y-stents can effectively occlude the thoracostomach-airway fistula in patients who had had the esophageal tumors resected. The technique is not only feasible but reliable to improve the quality of life of the patients.

Cost-Effectiveness Analysis of Infrapopliteal Drug-Eluting Stents

DOE Office of Scientific and Technical Information (OSTI.GOV)

Katsanos, Konstantinos, E-mail: katsanos@med.upatras.gr; Karnabatidis, Dimitris; Diamantopoulos, Athanasios

2013-02-15

IntroductionThere are no cost-utility data about below-the-knee placement of drug-eluting stents. The authors determined the cost-effectiveness of infrapopliteal drug-eluting stents for critical limb ischemia (CLI) treatment. The event-free individual survival outcomes defined by the absence of any major events, including death, major amputation, and target limb repeat procedures, were reconstructed on the basis of two published infrapopliteal series. The first included spot Bail-out use of Sirolimus-eluting stents versus bare metal stents after suboptimal balloon angioplasty (Bail-out SES).The second was full-lesion Primary Everolimus-eluting stenting versus plain balloon angioplasty and bail-out bare metal stenting as necessary (primary EES). The number-needed-to-treat (NNT) tomore » avoid one major event and incremental cost-effectiveness ratios (ICERs) were calculated for a 3-year postprocedural period for both strategies. Overall event-free survival was significantly improved in both strategies (hazard ratio (HR) [confidence interval (CI)]: 0.68 [0.41-1.12] in Bail-out SES and HR [CI]: 0.53 [0.29-0.99] in Primary EES). Event-free survival gain per patient was 0.89 (range, 0.11-3.0) years in Bail-out SES with an NNT of 4.6 (CI: 2.5-25.6) and a corresponding ICER of 6,518 Euro-Sign (range 1,685-10,112 Euro-Sign ). Survival gain was 0.91 (range 0.25-3.0) years in Primary EES with an NNT of 2.7 (CI: 1.7-5.8) and an ICER of 11,581 Euro-Sign (range, 4,945-21,428 Euro-Sign ) per event-free life-year gained. Two-way sensitivity analysis showed that stented lesion length >10 cm and/or DES list price >1000 Euro-Sign were associated with the least economically favorable scenario in both strategies. Both strategies of bail-out SES and primary EES placement in the infrapopliteal arteries for CLI treatment exhibit single-digit NNT and relatively low corresponding ICERs.« less

Application of rotational atherectomy in the drug-eluting stent era

PubMed Central

Chen, Chun-Chi; Hsieh, I-Chang

2013-01-01

Rotational atherectomy (RA) was introduced in the interventional arena in 1988 as a dedicated device for calcified lesions. Due to the complexity of the technique, the development of alternative methods such as the cutting balloon procedure, and the high restenosis rate of subsequent bare metal stenting in long lesions, its use had later declined. However, with the increasing use of drug-eluting stents (DES) and the aggressive treatment of longer lesions, the number of procedure performed with RA has increased significantly again in recent years. In this article, we reviewed the application of RA in DES era. PMID:24133506

The use of drug-coated balloons in the treatment of femoropopliteal and infrapopliteal disease.

PubMed

Li, Jun; Karim, Adham; Shishehbor, Mehdi

2018-05-25

While the field of endovascular interventions has evolved in the last decade, technological advancements have rendered drug-coated balloons (DCBs) to be the first line therapy for femoropopliteal artery disease. As the knowledge continues to advance, the application of DCB to the infrapopliteal segments and its role in the setting of plaque modification atherectomy to minimize stent utilization will be further elucidated.

Future developments in biliary stenting

PubMed Central

Hair, Clark D; Sejpal, Divyesh V

2013-01-01

Biliary stenting has evolved dramatically over the past 30 years. Advancements in stent design have led to prolonged patency and improved efficacy. However, biliary stenting is still affected by occlusion, migration, anatomical difficulties, and the need for repeat procedures. Multiple novel plastic biliary stent designs have recently been introduced with the primary goals of reduced migration and improved ease of placement. Self-expandable bioabsorbable stents are currently being investigated in animal models. Although not US Food and Drug Administration approved for benign disease, fully covered self-expandable metal stents are increasingly being used in a variety of benign biliary conditions. In malignant disease, developments are being made to improve ease of placement and stent patency for both hilar and distal biliary strictures. The purpose of this review is to describe recent developments and future directions of biliary stenting. PMID:23837001

Hemodynamic Performance of a Novel Right Ventricular Assist Device (PERKAT).

PubMed

Kretzschmar, Daniel; Schulze, P Christian; Ferrari, Markus W

Acute right ventricular failure (RVF) is an increasing clinical problem and a life-threatening condition. Right ventricular assist devices represent a reasonable treatment option for patients with refractory RVF. We here present a novel percutaneously implantable device for right ventricular support. The PERKAT device is based on a nitinol stent cage, which is covered with valve-carrying foils. A flexible outlet trunk with a pigtail tip is connected to the distal part. The device is driven by an intra-aortic balloon pump (IABP) drive unit, which inflates/deflates a standard IABP-balloon placed within the stent cage. In-vitro evaluation was done in a liquid bath containing water or blood analog. The PERKAT device was tested in different afterload settings using two different IABP-balloons and varying inflation/deflation rates. We detected flow rates ranging from 1.97 to 3.93 L/min depending on the afterload setting, inflation/deflation rate, balloon size, and the medium used. Flow rates between water and blood analog were nearly comparable, and in the higher inflation/deflation rate settings slightly higher with water. Based on this promising in vitro data, the innovative percutaneously implantable PERKAT device has a potential to become a therapeutic option for patients with RVF refractory to medical treatment.

Surgical treatment for Ellis type 3 coronary perforation during percutaneous catheter intervention.

PubMed

Totsugawa, Toshinori; Kuinose, Masahiko; Yoshitaka, Hidenori; Katayama, Keijiro; Tsushima, Yoshimasa; Ishida, Atsuhisa; Chikazawa, Genta; Hiraoka, Arudo

2012-01-01

Coronary perforation (CP) is a rare, but sometimes lethal, complication of percutaneous catheter intervention (PCI). We reviewed surgically-treated cases of type 3 CP during PCI. From 2007 to 2010, 5 patients underwent surgical repair for type 3 CP (3 men, 2 women; mean age, 74 years). The mean number of diseased coronary branches was 2.6 and the mean SYNTAX score was 45. The target lesions were the left anterior descending artery in 4 cases and the right coronary artery in 1 case. Types of American Heart Association/American College of Cardiology classification were type B2 in only one case and type C in 4 cases. The causes of perforation were balloon inflation in 4 patients and rotational atherectomy in 1 patient. The in-hospital mortality rate was 20%. In the cases of CP associated with balloon inflation, coronary lacerations were so severe that re-bleeding occurred even if the covered stent could temporarily achieve hemostasis, and percutaneous cardiopulmonary support and emergency surgery were required. CP induced by balloon inflation tends to result in a serious condition compared with rotablator-induced CP. Surgery should be immediately performed even after covered stent implantation if there is any possibility of re-bleeding in the case of balloon-induced type 3 CP.

Limb-shaking transient ischemic attack masquerading as lumbar radiculopathy from pericallosal artery stenosis treated successfully with intracranial angioplasty and stenting.

PubMed

Kalia, Junaid; Wolfe, Thomas; Zaidat, Osama O

2010-03-01

The pericallosal artery is rarely associated with intracranial atherosclerotic disease and, until recently, was usually not amenable to endovascular therapy with balloon angioplasty and stenting. We present an elderly patient with postural left leg-shaking episodes secondary to pericallosal artery stenosis, which was treated initially with primary intracranial balloon angioplasty, and subsequently, angioplasty and stenting as a result of recurrent stenosis. Both procedures were preformed without complications, and the patient remained free of symptoms on 6-month follow-up. This case demonstrates unique clinical and neuroendovascular aspects; the isolated postural leg-shaking transient ischemic attacks, initially mistaken for radiculopathy and local joint etiology, were found later to be cerebrovascular ischemic in origin. Moreover, the correlation between the findings of computed tomography perfusion and angiography localized the lesion into the medial frontal lobe and pericallosal artery territory. In addition, the technical aspect provides insight into the current state of neuroendovascular techniques, addressing the difficulty of access into very small and distal intracranial arteries affected by stenosis. Copyright 2010 National Stroke Association. Published by Elsevier Inc. All rights reserved.

Malignant Esophagogastric Junction Obstruction: Efficacy of Balloon Dilation Combined with Chemotherapy and/or Radiation Therapy

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ko, Gi-Young; Song, Ho-Young, E-mail: hysong@amc.seoul.kr; Hong, Heuk-Jin

2003-04-15

Purpose: To assess the efficacy of balloon dilation combined with chemotherapy and/or radiation therapy for palliation of dysphagia due to malignant esophagogastric junction strictures. Methods: Fluoroscopically guided balloon dilation was attempted in 20 patients. The causes of strictures were gastric adenocarcinoma (n = 10) and esophageal squamous cell carcinoma (n = 10). Scheduled chemotherapy and/or radiation therapy followed balloon dilation in all patients. Results: There were no technical failures or major complications. After balloon dilation, 15 (75%) patients showed improvement of dysphagia. No patient complained of reflux esophagitis during the follow-up period. Among the 15 patients, seven needed no furthermore » treatment for palliation of dysphagia until their deaths. The remaining eight patients underwent repeat balloon dilation(n = 4) or stent placement (n = 4)3-43 weeks (mean 15 weeks) after the initial balloon dilation because of recurrent dysphagia. Conclusion: Balloon dilation combined with chemotherapy and/or radiation therapy seems to be an easy and reasonably effective palliative treatment for malignant esophagogastric strictures.« less

Percutaneous stent placement for the treatment of malignant biliary obstruction: nitinol versus elgiloy stents.

PubMed

Zurstrassen, Charles Edouard; Bitencourt, Almir Galvão Vieira; Guimaraes, Marcos Duarte; Cavalcante, Aline Cristine Barbosa Santos; Tyng, Chiang Jeng; Amoedo, Mauricio Kauark; Matsushita Junior, João Paulo Kawaoka; Szklaruk, Janio; Marchiori, Edson; Chojniak, Rubens

2017-01-01

This study aimed to compare two self-expanding stents, a nitinol stent and an elgiloy stent, both placed percutaneously, in terms of their efficacy in palliating inoperable malignant biliary obstruction. We retrospectively investigated 99 patients with unresectable malignant biliary obstruction treated with percutaneous placement of a self-expanding metallic stent at our institution between May 2007 and January 2010. Serum bilirubin and liver enzyme levels were measured before and 30 days after stenting. For all procedures using elgiloy or nitinol stents, stent occlusion and patient survival rates were calculated using Kaplan-Meyer analysis. All of the patients showed clinical improvement after stent placement, with no difference between the two groups. In both groups, the occlusion-free survival rate was 67% at 30 days, 37% at 90 days, 25% at 180 days, and 10% at 360 days, with no significant difference in relation to the type of stent. The two stents evaluated showed comparable efficacy for the percutaneous treatment of unresectable biliary malignancy, with good clinical results.

Chemotherapy versus self-expanding metal stent as primary treatment of severe dysphagia from unresectable oesophageal or gastro-oesophageal junction cancer.

PubMed

Touchefeu, Yann; Archambeaud, Isabelle; Landi, Bruno; Lièvre, Astrid; Lepère, Céline; Rougier, Philippe; Mitry, Emmanuel

2014-03-01

To compare chemotherapy first (group 1) versus self-expanding metal stent first (group 2) for the management of malignant dysphagia in unresectable oesophageal or gastro-oesophageal junction cancer. Patients from two university hospitals with severe malignant dysphagia (dysphagia score ≥ 2) uneligible for surgery or radiochemotherapy were evaluated retrospectively. Forty-two patients were included in group 1, and 29 in group 2. After 4 weeks, dysphagia scores improved by at least 1 point in 67% of patients in group 1 versus 93% in group 2 (p=0.01); 48% of patients in group 1 were able to eat solid food versus 68% in group 2 (p=0.054). In group 1, a self-expanding metal stent was secondarily placed in 18 patients (42.9%), whereas in group 2 dysphagia required a second self-expanding metal stent placement in 33.3% of patients. Chemotherapy as the first treatment may be a valid option, avoiding self-expanding metal stent insertion in half of the patients. Copyright © 2013 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

Clinical feasibility of a new through-the-scope fully covered esophageal self-expandable metallic stent: an in vivo animal study.

PubMed

Cheon, Young Koog; Lee, Tae Yoon; Sung, In Kyung; Shim, Chan Sup

2014-01-01

Most delivery devices used for esophageal stents for obstructing esophageal cancer have a diameter of 5-8 mm, a size that is too large to pass through the endoscopic working channel. The conventional esophageal stent requires multiple endoscopic procedures for implantation. The purpose of the present study was to evaluate the clinical feasibility of a newly developed fully covered, self-expanding, through-the-scope (TTS) esophageal stent in a porcine model. Eight mini pigs were used. Each animal underwent placement of a fully covered TTS stent (Hanarostent® Esophagus TTS) and the upper part of the stent was fixed by suturing with nylon. Fluoroscopy was carried out every week to assess migration of the stent. Follow-up endoscopy was done every month for 3 months to evaluate the status of the membrane, stent mesh, grade of tissue hyperplasia, and mucosal changes at both ends of the stent. All stents were successfully and easily deployed, and were placed without any distortion in the stent or without rupture of the membrane. In two cases, stent migration was observed after 8 weeks. No case of membrane disruption, stent mesh disruption or tissue hyperplasia at either end of the stent was found at the completion of the study. Our findings indicate that the new fully covered self-expanding TTS esophageal stent is easy and simple to implant, and no significant distortion of mesh or disruption of membrane was observed. © 2013 The Authors. Digestive Endoscopy © 2013 Japan Gastroenterological Endoscopy Society.

Percutaneous Transcholecystic Biliary Interventions Using Gallbladder Anchors: Feasibility Study in the Swine

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lopera, Jorge E., E-mail: jloper@lsuhsc.edu; Kirsch, David; Qian Zhong

2005-05-15

The purpose of this study was to report our initial experience with a swine model for biliary interventions by using a percutaneous transcholecystic access after suture anchor of the gallbladder. Telepaque tablets were given to five pigs to opacify the gallbladder. Under fluoroscopy, the opacified gallbladder was punctured percutaneously and three suture anchors were used to fix the anterior wall of the gallbladder to the abdominal wall. Two weeks later, the gallbladder was punctured and access into the distal common bile was obtained through the cystic duct. Balloon expandable stents were deployed into the distal common bile duct. Follow-up cholangiogramsmore » were obtained at 1 and 2 weeks. Necropsy was performed after 2 weeks to evaluate the relationship between the gallbladder and abdominal wall. Suture anchor placement was successful in all five pigs. One pig with a deep and highly positioned gallbladder developed fever, anorexia, and vomiting secondary to excessive stretch of the gallbladder. Placement of the guidewire through the extremely tortuous and small cystic ducts proved to be the most challenging step of the procedure. Metallic stents were successfully deployed in all four pigs in which it was attempted. Four animals tolerated the procedures without changes in their clinical conditions and no symptoms. Successful follow-up cholangiograms were performed at 1 and 2 weeks post-stent deployment without complications. All stents remained patent during the follow-up period. Necropsy demonstrated close attachment and adherence of the gallbladders to the antero-lateral abdominal wall in all four animals. Suture anchoring of the gallbladder is feasible in most pigs with superficially located gallbladders. This technique allows a safe and repeat access into the biliary system using a transcholecystic approach.« less

Percutaneous transcholecystic biliary interventions using gallbladder anchors: feasibility study in the swine.

PubMed

Lopera, Jorge E; Kirsch, David; Qian, Zhong; Ruiz, Bernardo; Brazzini, Augusto; Gonzales, Arturo; Castaneda-Zuniga, Wilfrido

2005-01-01

The purpose of this study was to report our initial experience with a swine model for biliary interventions by using a percutaneous transcholecystic access after suture anchor of the gallbladder. Telepaque tablets were given to five pigs to opacify the gallbladder. Under fluoroscopy, the opacified gallbladder was punctured percutaneously and three suture anchors were used to fix the anterior wall of the gallbladder to the abdominal wall. Two weeks later, the gallbladder was punctured and access into the distal common bile was obtained through the cystic duct. Balloon expandable stents were deployed into the distal common bile duct. Follow-up cholangiograms were obtained at 1 and 2 weeks. Necropsy was performed after 2 weeks to evaluate the relationship between the gallbladder and abdominal wall. Suture anchor placement was successful in all five pigs. One pig with a deep and highly positioned gallbladder developed fever, anorexia, and vomiting secondary to excessive stretch of the gallbladder. Placement of the guidewire through the extremely tortuous and small cystic ducts proved to be the most challenging step of the procedure. Metallic stents were successfully deployed in all four pigs in which it was attempted. Four animals tolerated the procedures without changes in their clinical conditions and no symptoms. Successful follow-up cholangiograms were performed at 1 and 2 weeks post-stent deployment without complications. All stents remained patent during the follow-up period. Necropsy demonstrated close attachment and adherence of the gallbladders to the antero-lateral abdominal wall in all four animals. Suture anchoring of the gallbladder is feasible in most pigs with superficially located gallbladders. This technique allows a safe and repeat access into the biliary system using a transcholecystic approach.

Development of tissue-engineered self-expandable aortic stent grafts (Bio stent grafts) using in-body tissue architecture technology in beagles.

PubMed

Kawajiri, Hidetake; Mizuno, Takeshi; Moriwaki, Takeshi; Ishibashi-Ueda, Hatsue; Yamanami, Masashi; Kanda, Keiichi; Yaku, Hitoshi; Nakayama, Yasuhide

2015-02-01

In this study, we aimed to describe the development of tissue-engineered self-expandable aortic stent grafts (Bio stent graft) using in-body tissue architecture technology in beagles and to determine its mechanical and histological properties. The preparation mold was assembled by insertion of an acryl rod (outer diameter, 8.6 mm; length, 40 mm) into a self-expanding nitinol stent (internal diameter, 9.0 mm; length, 35 mm). The molds (n = 6) were embedded into the subcutaneous pouches of three beagles for 4 weeks. After harvesting and removing each rod, the excessive fragile tissue connected around the molds was trimmed, and thus tubular autologous connective tissues with the stent were obtained for use as Bio stent grafts (outer diameter, approximately 9.3 mm in all molds). The stent strut was completely surrounded by the dense collagenous membrane (thickness, ∼150 µm). The Bio stent graft luminal surface was extremely flat and smooth. The graft wall of the Bio stent graft possessed an elastic modulus that was almost two times higher than that of the native beagle abdominal aorta. This Bio stent graft is expected to exhibit excellent biocompatibility after being implanted in the aorta, which may reduce the risk of type 1 endoleaks or migration. © 2014 Wiley Periodicals, Inc.

[Stent-assisted recanalization of femoropopliteal arterial occlusive disease. Influence of stent design on patency rates].

PubMed

Treitl, M; Reiser, M F; Treitl, K M

2016-03-01

Despite enormous technical progress the results of endovascular treatment of the femoropopliteal vasculature are unsatisfactory and its role is still controversially discussed. In the past decade numerous new stent designs have come onto the market but it is unclear whether they have benefits with respect to patency rates. Comparison of published data on patency rates and target lesion revascularization rates after use of different stent designs in the femoropopliteal vasculature. Analysis of 25 published studies and registries from 2006 to 2015 for classical open-cell stents, interwoven stents and partially or fully covered stents. The published data are heterogeneous and comparative studies for different stent designs are completely missing. Over the past decade the patency rates after femoropopliteal stenting could be improved. According to available data stenting of short lesions < 5 cm does not show any benefit compared to isolated balloon angioplasty. Primary stenting is now recommended for intermediate and longer lesions > 6.4 cm. Due to the heterogeneity of published data a clear benefit for a specific stent design is not obvious; however, data for interwoven stents are promising and show a tendency towards improved patency, at least for certain lesions. Randomized controlled comparative trials are needed to confirm this result.

Natural stent in the management of post-intubation tracheal stenosis.

PubMed

Park, Hye Yun; Kim, Hojoong; Koh, Won-Jung; Suh, Gee Young; Chung, Man Pyo; Kwon, O Jung

2009-05-01

The treatment choice for post-intubation tracheal stenosis (PITS) in patients for whom surgery is not initially feasible is bronchoscopic silicone stenting. A new silicone stent, called the Natural stent (N stent), was investigated for its clinical efficacy and safety in patients with PITS. A retrospective review was conducted of 32 patients with PITS who underwent N stenting between November 2001 and December 2006 and were followed for at least 12 months. Airway dilatation with combined modalities such as Nd:YAG laser, ballooning or bougienage was followed by N stent insertion. After intervention, all patients had symptomatic and spirometric improvement without immediate complications. Removal of the stent without re-stenosis was successful in 38% of the patients at a median time of 7 months after insertion. The stent could not be removed or needed reinsertion in 31% of patients, and 16% of patients underwent surgery after initial stabilization by stenting. Late complications were stent migration (34%), mucostasis (31%), granulation tissue formation (38%) and re-stenosis (40%). All patients tolerated the management of complications during a median follow up of 22 months. Bronchoscopic N stenting is an effective treatment for patients with PITS in whom surgery is not feasible on initial presentation. Further stent development is necessary to reduce the late complication rate.

Biodegradable stents for the treatment of refractory or recurrent benign esophageal stenosis.

PubMed

Imaz-Iglesia, Iñaki; García-Pérez, Sonia; Nachtnebel, Anna; Martín-Águeda, Belén; Sánchez-Piedra, Carlos; Karadayi, Bilgehan; Demirbaş, Ali Rıza

2016-06-01

Esophageal stents are used for the treatment of refractory and recurrent dyphagias. In 2007, esophageal biodegradable stents (EBS) were authorised as an alternative to existing metal and plastic stents in Europe. The advantages claimed for EBS are fewer complications concerning tissue ingrowth, stent migration and stent removal. We performed a systematic review to evaluate the efficacy and safety of EBS compared to fully-covered self-expanding metal stents, self-expanding plastic stents, and esophageal dilation for the treatment of refractory or recurrent benign esophageal stenosis. Three comparative studies (one randomized controlled trial and two cohort studies) were assessed. The studies used different inclusion criteria, had a very small (sample) size and the quality of the evidence was very low. Expert commentary: The current evidence is insufficient to determine the relative efficacy or safety of esophageal biodegradable stents. The results of this systematic review should be updated once new evidence is available.

A systematic review of biodegradable biliary stents: promising biocompatibility without stent removal.

PubMed

Siiki, Antti; Sand, Juhani; Laukkarinen, Johanna

2018-05-18

Biodegradable self-expanding stents are an emerging alternative to standard biliary stents as the development of endoscopic insertion devices advances. The aim was to systematically review the existing literature on biodegradable biliary stents. In-vivo studies on the use of biodegradable stents in the biliary duct were systematically reviewed from 1990 to 2017. Despite extensive research on the biocompatibility of stents, the experience so far on their clinical use is limited. A few favorable reports have recently been presented on endoscopically and percutaneously inserted self-expanding biodegradable polydioxanone stents in benign biliary strictures. Another potential indication appears to be postcholecystectomy leak of the cystic duct. The main benefit of biodegradable stents is that stent removal can be avoided. The biocompatibility of the current biodegradable stent materials, most prominently polydioxanone, is well documented. In the few studies currently available, biodegradable stents are reported to be feasible and safe, also in humans. The initial results of the endoscopic use of these stents in benign biliary stricture management and for treating postcholecystectomy bile leaks are promising. Further controlled studies on long-term clinical results and cost-effectiveness are needed.

Early Strut Coverage in Patients Receiving Drug-Eluting Stents and its Implications for Dual Antiplatelet Therapy: A Randomized Trial.

PubMed

Lee, Seung-Yul; Kim, Jung-Sun; Yoon, Hyuck-Jun; Hur, Seung-Ho; Lee, Sang-Gon; Kim, Jin Won; Hong, Young Joon; Kim, Ki-Seok; Choi, So-Yeon; Shin, Dong-Ho; Nam, Chung-Mo; Kim, Byeong-Keuk; Ko, Young-Guk; Choi, Donghoon; Jang, Yangsoo; Hong, Myeong-Ki

2018-02-09

This study sought to measure early strut coverage in patients receiving drug-eluting stents (DESs) and to explore the feasibility of short-term dual antiplatelet therapy (DAPT) based on the degree of early strut coverage. Data for early strut coverage in patients receiving new-generation DESs, and its implications for DAPT continuation were limited. A randomized, multicenter trial was conducted in 894 patients treated with DESs. Patients were randomly assigned to everolimus-eluting stent (EES) (n = 444) or biolimus-eluting stent (BES) (n = 450) groups and optical coherence tomography (OCT)-guided (n = 445) or angiography-guided (n = 449) implantation groups using a 2-by-2 factorial design. Early strut coverage was measured as the percentage of uncovered struts on 3-month follow-up OCT examination. The primary outcome was the difference in early strut coverage between EES and BES groups and between OCT- and angiography-guided implantation groups. The secondary outcome was a composite of cardiac death, myocardial infarction, stent thrombosis, and major bleeding during the first 12 months post-procedure in patients receiving 3-month DAPT based on the presence of early strut coverage (≤6% uncovered) on 3-month follow-up OCT. Three-month follow-up OCT data were acquired for 779 patients (87.1%). The median percentage of uncovered struts at 3 months was 8.9% and 8.2% in the EES and BES groups, respectively (p = 0.69) and was lower in the OCT-guided group (7.5%) than in the angiography-guided group (9.9%; p = 0.009). Favorable early strut coverage (≤6% uncovered strut) was observed in 320 of 779 patients (41.1%). At 12 months, the composite event rarely occurred in the 3-month (0.3%) or 12-month (0.2%) DAPT groups (p = 0.80). OCT-guided DES implantation improved early strut coverage compared with angiography-guided DES implantation, with no difference in strut coverage between EES and BES groups. Short-term DAPT may be feasible in selected patients with favorable early strut coverage (Determination of the Duration of the Dual Antiplatelet Therapy by the Degree of the Coverage of The Struts on Optical Coherence Tomography From the Randomized Comparison Between Everolimus-eluting Stents Versus Biolimus A9-eluting Stents [DETECT-OCT]; NCT01752894). Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Self-Expandable Metal Stents and Trans-stent Light Delivery: Are Metal Stents and Photodynamic Therapy Compatible?

PubMed Central

Wang, Luo-Wei; Li, Li-Bo; Li, Zhao-Shen; Chen, Yang K; Hetzel, Fred W.; Huang, Zheng

2008-01-01

Background and Objectives: Obstructive non-small cell lung cancer and obstructive esophageal cancer are US FDA approved indications of photodynamic therapy (PDT). The usefulness of PDT for the treatment of cholangiocarcinoma is currently under clinical investigation. Endoscopic stenting for lumen restoration is a common palliative intervention for those indications. It is important to assess whether self-expandable metal stents are compatible with trans-stent PDT light delivery. Study Design/Materials and Methods: Direct effects of various components of metal biliary (n = 2), esophageal (n = 2), and bronchial (n = 1) stents on PDT light transmittance and distribution were examined using a point or linear light source (630 or 652 nm diode laser). Resected pig biliary duct and esophageal wall tissues were used to examine the feasibility of PDT light delivery through the fully expanded metal stents. Results: While using a point light source, the metal components (thread and joint) of the stent could cause a significant shadow effect. The liner material (polytetrafluoroethylene or polyurethane) could cause various degrees of light absorption. When the stent was covered with a thin layer of biliary duct and esophageal tissues containing all wall layers, the shadow effect could be mitigated due to tissue scattering. Conclusions: This study clearly demonstrates that it is feasible to combine stenting and PDT for the treatment of luminal lesions. PDT light dose should be adjusted to counteract the reduction of light transmittance caused by the metal and liner materials of stent. PMID:18951422

DOE Office of Scientific and Technical Information (OSTI.GOV)

Miyayama, Shiro, E-mail: s-miyayama@fukui.saiseikai.or.jp; Yamashiro, Masashi; Takeda, Taro

We report the successful management of acute cholecystitis using cystic duct stent placement in 3 patients with inoperable malignant cystic duct obstruction (2 cholangiocarcinoma and 1 pancreatic carcinoma). All patients underwent stent placement in the bile duct, using an uncovered stent in 2 and a covered stent in 1, to relieve jaundice occurring 8-184 days (mean 120 days) before the development of acute cholecystitis. The occluded cystic duct was traversed by a microcatheter and a stent was implanted 4-17 days (mean 12 days) after cholecystostomy. Acute cholecystitis was improved after the procedure in all patients. Two patients died 3 andmore » 10 months later, while 1 has survived without cholecystitis for 22 months after the procedure to date.« less

Clinical application of the Natural Y stent in the management of benign carinal stenosis.

PubMed

Nam, Hae-Seong; Um, Sang Won; Koh, Won-Jung; Suh, Gee Young; Chung, Man Pyo; Kwon, O Jung; Kim, Jhingook; Kim, Hojoong

2009-08-01

The Y-shaped structure of the carinal bifurcation causes difficulties in the treatment of carinal stenosis. We describe a new Y-shaped silicone stent, called the Natural Y stent. We investigated its clinical efficacy through a review of patients with benign carinal stenosis who undewent consecutive Natural Y stent placement. Between January 2004 and February 2008, 11 patients underwent ballooning, neodymium:yttrium-aluminum-garnet laser resection, or bougienation (by rigid bronchoscopy) to dilate the airway, followed by placement of the Natural Y stent. The underlying etiologies of carinal stenosis included posttuberculosis stricture in 7 patients (64%), postintubation stenosis in 2 (18%), and postoperative malacia in 2 (18%). All patients reported subjective symptomatic relief immediately after stent placement. No procedurally related deaths or immediate major complications occurred. Stent-related late complications included granulation tissue formation (64%) and mucostasis (18%, defined as > or = 50% narrowing). The median duration of overall stent placement was 439 days (range, 119 to 1729 days). The stents were successfully removed in 4 patients (36%) after a median of 409 days. The Natural Y stent provides an effective and feasible therapeutic modality in patients with benign carinal stenosis, with or without previous thoracic airway interventions.

Thoracic Discitis as a Complication of Self-Expanding Metallic Stents in Esophageal Carcinoma

DOE Office of Scientific and Technical Information (OSTI.GOV)

McQueen, A. S.; Eljabu, W.; Latimer, J., E-mail: joanne.latimer@nth.nhs.uk

2011-02-15

The role of metallic stents in the palliation of esophageal cancer is well established. Self-expanding metal stents (SEMSs) are frequently used, as they provide an effective and safe method of relieving malignant dysphagia. A number of complications are associated with the use of SEMSs, including esophageal perforation. We report a case of thoracic discitis occurring in a patient with advanced esophageal malignancy, treated with SEMSs. We propose that the likely etiology in this patient was esophageal perforation by a metallic stent.

Comparison of BMSs with SES for Symptomatic Intracranial Disease of the Middle Cerebral Artery Stenosis

DOE Office of Scientific and Technical Information (OSTI.GOV)

Yue Xuanye; Yin Qin; Xi Gangming

2011-02-15

This study was designed to compare the clinical and angiographic outcomes of patients with symptomatic atherosclerotic middle cerebral artery stenosis treated with balloon-mounted stents (BMS) and self-expandable Wingspan system (SES). We reviewed the 69 consecutive stent placement procedures for symptomatic atherosclerotic stenosis ({>=}70) in M1 segment of middle cerebral artery in 67 patients in 3 years. According to the stent types, the patients were classed as BMS and SES groups. The demographic characteristics, conventional risk factors of ischemic stroke, degree of stenosis, periprocedural complications, stent types, and clinical and angiographic outcomes were analyzed. There were 39 patients in the BMSmore » group and 28 patients in the SES group. The demographic characteristics, conventional risk factors, and periprocedural complications were similar but different in residual stenosis after stenting in both groups (5.9% {+-} 9.9% vs. 14.4% {+-} 14.6%; P = 0.01). For the overall cohort, the rate of stroke or death and restenosis was 10.9% (7/66) and 24.5% (14/57), respectively. The frequency of restenosis was higher in the SES group than in the BMS group (log-rank, P = 0.04; crude hazard ratio = 3.03; 95% confidence interval (CI), 1.01-9.15; P = 0.049; and adjusted hazard ratio = 3.61; 95% CI, 1.06-12.27; P = 0.04); however, there was no difference in clinical outcomes (log-rank, P = 0.51; crude hazard ratio = 1.66; 95% CI, 0.36-7.61; P = 0.51; and adjusted hazard ratio = 0.59; 95% CI, 0.04-7.89; P = 0.69). The corrected degree of restenosis was higher in the SES than the BMS group. The prevalence of restenosis was higher in the SES than the BMS group, but the perioperative complications and follow-up clinical outcomes had no significant difference.« less

Temporary placement of covered self-expandable metallic stents in the management of benign biliary strictures.

PubMed

Yasuda, Ichiro; Mukai, Tsuyoshi; Doi, Shinpei; Tomita, Eiichi; Moriwaki, Hisataka

2012-05-01

Currently, endoscopic intervention is widely attempted as the first-line treatment of benign biliary strictures because of its convenience and low morbidity. Plastic tube stents (PS) are usually used for such treatment; however, covered self-expandable metallic stents (C-SEMS) are becoming more commonly used at some institutions. The temporary placement of C-SEMS may lead to better outcomes because of their larger diameter and, therefore, better dilation of the stricture, especially in refractory cases. The aim of the present study was to evaluate the efficacy of the temporary placement of C-SEMS in the management of benign biliary strictures. We retrospectively reviewed our endoscopic retrograde cholangiopancreatography (ERCP) database (May 1996 to December 2010), and extracted the data of patients who underwent endoscopic treatment for benign biliary strictures. Then, the follow-up data from patient charts were reviewed to determine the long-term outcomes of those procedures. All patients (n = 56) initially had a PS placed, with or without balloon dilation. However, C-SEMS placement was later attempted in 12 patients because the stricture was refractory to placement of the PS. During their follow-up periods, two patients died of unrelated diseases after 15 and 17 months, and another two still had the C-SEMS in place after 9 and 50 months. In the remaining eight patients, the C-SEMS was removed after a median placement period of 6 months (range, 2-15). Seven patients in this group have not experienced a recurrence at a median follow-up time of 48 months. However, in one patient, stenosis did recur 8 months after the C-SEMS was removed. Temporary placement of C-SEMS can be a treatment option for benign biliary strictures, especially in refractory cases. © 2012 The Authors. Digestive Endoscopy © 2012 Japan Gastroenterological Endoscopy Society.

Strategies for the Management of SVC Stent Migration into the Right Atrium

DOE Office of Scientific and Technical Information (OSTI.GOV)

Taylor, J. D., E-mail: drjeremytaylor@yahoo.co.uk; Lehmann, E. D.; Belli, A.-M.

Purpose. Stent migration into the right atrium is a potentially fatal complication of stenting in the venous system and is most likely to occur during the treatment of superior vena cava obstruction. Endovascular approaches that can salvage this hazardous situation are described and the keys to successful treatment are highlighted. Materials and Methods. Four different strategies are reviewed: (1) snaring the stent directly, (2) angioplasty balloon-assisted snaring of the stent, (3) guide wire-assisted snaring of the stent, and (4) superior vena cava-to-inferior vena cava bridging stent. Results. These techniques have been employed in the successful management of four cases. Nomore » short- or long-term complications as a result of these maneuvers have been identified. Additional treatment of the underlying disease was possible at the same time in each case. Conclusion. We conclude that prompt management of right atrial stent migration is essential and can be successfully achieved by a variety of 'bale-out' techniques which are within the technical range of most interventional radiologists.« less

Self-expanding Y stents in the treatment of central airway stenosis: a retrospective analysis.

PubMed

Gompelmann, Daniela; Eberhardt, Ralf; Schuhmann, Maren; Heussel, Claus P; Herth, Felix J F

2013-10-01

Central airway obstruction (CAO) is a life-threatening situation. Stent insertion re-establishes patency of the central airways. Self-expanding metallic Y stents have been available since 2005, widening the spectrum of interventional bronchoscopic techniques. Retrospective analysis of all patients treated for CAO with a self-expanding metallic Y stent at the Thoraxklinik Heidelberg between May 2005 and January 2009. A total of 43 patients aged 26-81 had a metallic Y stent inserted endoscopically for the treatment of CAO; 39 of these patients (90.7%) had CAO due to malignant disease, four patients (9.3%) due to benign disease. In all 43 patients, the Y stent was deployed without any complications. A longitudinal follow up was possible in 32 of the 43 patients. The stents remained in situ for an average of 107.1 days (range 1-640 days). In 29 patients with malignant CAO the stenosis was successfully overcome with a Y stent; 11 of these patients died within 6 weeks following stent insertion. On follow up the remaining 18 patients showed immediate improvement of dyspnoea. Eight out of the 18 patients (44.4%) tolerated the stent without problems, two (11.1%) required further stenting, six (33.3%) had complications such as increased secretions, cough, dyspnoea or granulation tissue formation. The stent was removed in one patient (5.6%) due to increased secretions, and in another (5.6%) as the stent was no longer required due to successful tumour-specific therapy. Placement of Y stents in symptomatic CAO allows for quick relief of symptoms. Severe complications are rare. Stent removal is possible after successful treatment of the primary tumour. However, the prognostic indicator for survival is the underlying malignancy.

Fluoroscopically guided placement of self-expandable metallic stents and stent-grafts in the treatment of acute malignant colorectal obstruction.

PubMed

Kim, Honsoul; Kim, Seung Hyoung; Choi, Sun Young; Lee, Kwang-Hun; Won, Jong Yoon; Lee, Do Yun; Lee, Jong Tae

2008-12-01

To evaluate the technical feasibility and clinical effectiveness of fluoroscopically guided placement of self-expandable metallic stents and stent-grafts for acute malignant colorectal obstruction. Radiologic images and clinical reports of 42 patients (22 men, 20 women; age range, 28-93 years; median age, 65.5 years) who underwent fluoroscopically guided colorectal stent insertion without endoscopic assistance for acute malignant obstruction were reviewed retrospectively. Eighteen patients received bare stents as a bridge to surgery. Twenty-four patients received 27 insertions of either a bare stent (n = 15) or a stent-graft (n = 12) for palliation. The obstruction was located in the rectum (n = 8), sigmoid (n = 17), descending colon (n = 8), splenic flexure (n = 3), and transverse colon (n = 6). Clinical success, defined as more than 50% dilatation of the stent with subsequent symptomatic improvement, was achieved in 41 of the 42 patients (98%). No major procedure-related complications occurred. Minor complications occurred in eight of the 45 procedures (18%). No perioperative mortalities occurred within 1 month after surgery. In the palliative group, the median stent patency was 62 days (range, 0-1,014 days). There was no statistically significant difference in stent patency between the bare stents (range, 0-855 days; median, 68 days) and stent-grafts (range, 1-1,014 days; median, 81 days). Fluoroscopically guided placement of self-expandable metallic stents and stent-grafts for the relief of acute malignant colorectal obstruction was technically feasible without endoscopic assistance-even in lesions proximal to the splenic flexure and transverse colon-and clinically effective in both bridge to surgery and palliative management.

Midkine is expressed by infiltrating macrophages in in-stent restenosis in hypercholesterolemic rabbits.

PubMed

Narita, Hiroshi; Chen, Sen; Komori, Kimihiro; Kadomatsu, Kenji

2008-06-01

Neointimal hyperplasia is strikingly suppressed in an endothelium injury model in mice deficient in the growth factor midkine. Knockdown of midkine expression by means of antisense oligonucleotide or small interfering RNA has been shown to lead to suppression of neointimal hyperplasia in a balloon injury model and a rabbit vein graft model; therefore, midkine is an essential factor for neointimal hyperplasia. These findings, however, do not necessarily apply to the function of midkine in vascular stenoses such as in-stent restenosis, because human vascular stenosis is often accompanied by atherosclerosis. We investigated midkine expression in the neointima induced by implantation of a bare metal stent in the atheromatous lesions of hypercholesterolemic rabbits. We analyzed midkine expression during a THP-1 cell differentiation and in peritoneal macrophages exposed to low-density lipoprotein or oxidized low-density lipoprotein. Midkine expression reached the maximum level within 7 days after stenting and was detected in infiltrating macrophages. Differentiation of THP-1 cells to macrophage-like cells did not trigger midkine expression. Neither low-density lipoprotein nor oxidized low-density lipoprotein enhanced midkine expression in peritoneal macrophages that had been activated by thioglycollate, although these cells expressed a significant amount of midkine. The results indicate that macrophages are the major source of midkine in the atherosclerotic neointima. The amount of midkine expressed in macrophages may be sufficient (ie, further enhancement of the expression is not necessary) for the pathogenesis, because oxidized low-density lipoprotein stimulation did not induce the midkine expression. The growth factor midkine is induced during vascular stenosis in mouse and rat models with normal diet. Knockdown of midkine expression suppresses neointimal hyperplasia. The vascular response after stenting differs from that after balloon injury in that the inflammation is more prolonged and the accumulation of macrophages is more abundant in stent-injured vessel. We found here that macrophages are the major source of midkine in the atherosclerotic neointima of in-stent restenosis in hypercholesterolemic rabbits. Our data suggest that midkine has an important role in in-stent restenosis of atherosclerotic vessels and is a candidate molecular target to prevent in-stent restenosis.

The development of self-expanding peripheral stent with ion-modified surface layer

NASA Astrophysics Data System (ADS)

Lotkov, Alexander I.; Kashin, Oleg A.; Kudryashov, Andrey N.; Krukovskii, Konstantin V.; Kuznetsov, Vladimir M.; Borisov, Dmitry P.; Kretov, Evgenii I.

2016-11-01

In work researches of chemical composition of surface layers of self-expanding stents of nickel-titanium (NiTi) and their functional and mechanical properties after plasma immersion processing by ions of silicon (Si). It is established that in the treatment in the inner and outer surfaces of stents formed doped silicon layer with a thickness of 80 nm. The formation of the doped layer does not impair the functional properties of the stent. At human body temperature, the stent is fully restore its shape after removing the deforming load. The resulting graph of loading of stents during their compression between parallel plates. The research results allow the conclusion that Si-doped stents are promising for treatment of peripheral vascular disease. However, related studies on laboratory animals are required.

A new approach to improve the local compressive properties of PPDO self-expandable stent.

PubMed

Zhao, Fan; Xue, Wen; Wang, Fujun; Yu, Chenglong; Xu, Haiyan; Hao, Yi; Wang, Lu

2017-04-01

The radial performance of bioabsorbable polymeric intravascular stents is extremely important in assessing the efficiency of these devices in expanding narrow lumen, reducing stent recoil, and recovering to their original states after suffering from pulsating pressure. However, these stents remain inferior to metallic stents. Several thermal treatment conditions (60°C, 80°C, and 100°C for 1h) were investigated to improve the characteristics of poly(p-dioxanone) (PPDO) self-expandable stents. The local compressive force, stiffness, and viscoelasticity of these stents were also evaluated. Wide-angle X-ray diffraction and different scanning calorimetry measurements were performed to evaluate the recrystalline and thermodynamic changes of molecular chains. The declining conformer entropy of PPDO monofilaments was examined via energy analysis. The untreated stents had compressive modules of 514.80±70.59mN/mm, which was much higher than those of 80°C and 100°C treated stents (332.35±66.08mN/mm and 394.31±64.71mN/mm, respectively). Nevertheless, 100°C annealing stents had less stress relaxation and prior elastic recovery rate of 82.32±3.43mN and 92.55±1.61%, respectively, showing a much better shape stability than untreated stents (139.51±16.67mN and 86.18±3.57%, respectively). These findings present important clinical implications in the stent manufacturing process and warrant further study to develop new bioabsorbable stents with outstanding clinical efficacy. Copyright © 2017 Elsevier Ltd. All rights reserved.

Fracture, inflation and floatation embolisation of PTCA balloon.

PubMed

O'Neill, Louisa; Sowbhaga, Vinay; Owens, Patrick

2015-01-09

This case outlines an unusual complication of coronary intervention, the likely mechanisms leading to this and possible retrieval options. It is the first case to the best of our knowledge reporting this complication. A 78-year-old Caucasian man underwent coronary stenting. During the procedure kinking and subsequent fracture of a non-compliant percutaneous transluminal coronary angioplasty (PTCA) balloon occurred. Injection of contrast down the guide to opacify the coronary arteries resulted in 'inflation' of the balloon with air, and embolisation of the inflated balloon into the proximal left anterior descending artery. The embolised balloon was retrieved by removal of the guide catheter and wire as a unit. The patient had a good angiographic outcome. This case highlights risks associated with usage of kinked balloons catheters, and describes for the first time to our knowledge, the inflation of a PTCA balloon with air from its shaft within the catheter, causing 'floatation' embolisation into the coronary artery. 2015 BMJ Publishing Group Ltd.

Fracture, inflation and floatation embolisation of PTCA balloon

PubMed Central

O'Neill, Louisa; Sowbhaga, Vinay; Owens, Patrick

2015-01-01

This case outlines an unusual complication of coronary intervention, the likely mechanisms leading to this and possible retrieval options. It is the first case to the best of our knowledge reporting this complication. A 78-year-old Caucasian man underwent coronary stenting. During the procedure kinking and subsequent fracture of a non-compliant percutaneous transluminal coronary angioplasty (PTCA) balloon occurred. Injection of contrast down the guide to opacify the coronary arteries resulted in ‘inflation’ of the balloon with air, and embolisation of the inflated balloon into the proximal left anterior descending artery. The embolised balloon was retrieved by removal of the guide catheter and wire as a unit. The patient had a good angiographic outcome. This case highlights risks associated with usage of kinked balloons catheters, and describes for the first time to our knowledge, the inflation of a PTCA balloon with air from its shaft within the catheter, causing ‘floatation’ embolisation into the coronary artery. PMID:25576524

Endovascular treatment of atherosclerotic popliteal artery disease based on dynamic angiography findings.

PubMed

Cui, Chaoyi; Huang, Xintian; Liu, Xiaobing; Li, Weimin; Lu, Xinwu; Lu, Min; Jiang, Mier; Yin, Minyi

2017-01-01

To evaluate efficacy, safety, and midterm patency of endovascular treatment of obstructive popliteal artery (PA) disease. A retrospective evaluation of patients with atherosclerotic PA disease who underwent percutaneous transluminal balloon angioplasty and provisional stent, based on both conventional and dynamic angiographies, was conducted from June 2011 to June 2014. Forty-three patients were included in the study, and most patients had limited surgical revascularization options. Demographic characteristics, angiographic findings, interventional data, complications, vessel patency, limb salvage rates, and survival rates were analyzed. The median lesion length was 5 cm with 72.1% having total occlusions. The second popliteal segment (P2) was involved most frequently (60.5%, n = 26). Critical limb ischemia was present in 69.8%. The technical success rate was 92.9% (42/43 limbs), with 29 cases requiring adjunctive nitinol stents after balloon angioplasty (47.6% based on conventional angiography, 21.4% based on dynamic angiography, and 4.8% additional stents based on dynamic angiography). Complications included thromboembolism (2.3%), perforation (2.3%), pseudoaneurysm (2.3%), and myocardial infarction (2.3%). Stent fracture was present in three cases (7.1%) during the mean follow-up period of 18.3 months. The baseline ankle-brachial index significantly improved after the intervention, from 0.49 ± 0.11 to 0.92 ± 0.14 (P < .01). The Rutherford-Becker class decreased from 3.95 ± 0.76 to 1.76 ± 0.95 (P < .01) at 12 months. The 1-year primary, primary-assisted, and secondary patency rates were 75.2% ± 6.8%, 82.4% ± 6.0%, and 89.9% ± 4.8%, respectively. The limb salvage and amputation-free survival rates at 12 months were 91.6% and 87.0%, respectively. Balloon angioplasty with a provisional stent based on dynamic angiography is a feasible, safe, and effective therapy for patients with obstructive PA disease. Although the occurrence of stent fracture is still inevitable, patients with critical limb ischemia who have limited surgical options may get more benefits from the endovascular treatment of PA obstructive diseases. Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

A comparison of the temporary placement of 3 different self-expanding stents for the treatment of refractory benign esophageal strictures: a prospective multicentre study

PubMed Central

2012-01-01

Background Refractory benign esophageal strictures (RBESs) have been treated with the temporary placement of different self-expanding stents with conflicting results. We compared the clinical effectiveness of 3 types of stents: self-expanding plastic stents (SEPSs), biodegradable stents, and fully covered self-expanding metal stents (FCSEMSs), for the treatment of RBES. Methods This study prospectively evaluated 3 groups of 30 consecutive patients with RBESs who underwent temporary placement of either SEPSs (12 weeks, n = 10), biodegradable stents (n = 10) or FCSEMSs (12 weeks, n = 10). Data were collected to analyze the technical success and clinical outcome of the stents as evaluated by recurrent dysphagia, complications and reinterventions. Results Stent implantation was technically successful in all patients. Migration occurred in 11 patients: 6 (60%) in the SEPS group, 2 (20%) in the biodegradable group and 3 (30%) in the FCSEMS group (P = 0.16). A total of 8/30 patients (26.6%) were dysphagia-free after the end of follow-up: 1 (10%) in the SEPS group, 3 (30%) in the biodegradable group and 4 (40%) in the FCSEMS group (P = 0.27). More reinterventions were required in the SEPS group (n = 24) than in the biodegradable group (n = 13) or the FCSEMS group (n = 13) (P = 0.24). Multivariate analysis showed that stricture length was significantly associated with higher recurrence rates after temporary stent placement (HR = 1.37; 95% CI = 1.08-1.75; P = 0.011). Conclusions Temporary placement of a biodegradable stent or of a FCSEMS in patients with RBES may lead to long-term relief of dysphagia in 30 and 40% of patients, respectively. The use of SEPSs seems least preferable, as they are associated with frequent stent migration, more reinterventions and few cases of long-term improvement. Additionally, longer strictures were associated with a higher risk of recurrence. PMID:22691296

Patency of the Internal Iliac Artery after Placement of Common and External Iliac Artery Stents.

PubMed

Vinogradova, Margie; Lee, Hye Joon; Armstrong, Ehrin J; Laird, John; Humphries, Misty D

2017-01-01

Treatment of severe aortoiliac occlusive disease (AIOD) frequently requires long-segment stenting of the common and external iliac arteries (CIA and EIA, respectively). This study aims to analyze the patency of the internal iliac artery (IIA) after placement of a CIA and EIA stents across the orifice. A retrospective analysis of all patients who underwent de novo ipsilateral stent placement in the CIA and EIA between 2006 and 2013 was performed. Kaplan-Meier analysis was used to analyze patency of the IIA, and Cox proportional hazard models were used to identify characteristics associated with occlusion. We identified 77 patients and 93 limbs where ipsilateral CIA and EIA stents were placed. Preintervention angiographic review found 52 cases of a patent ipsilateral IIA where stents were placed across the origin of the IIA in 31 cases and staggered across the orifice in 20 limbs. Kaplan-Meier analysis demonstrated a 37% patency in limbs where the stent covered the IIA orifice compared to 78% patency in uncovered arteries (P = 0.04). New-onset buttock claudication developed in 4 patients, 2 with patent IIAs and 2 with occluded. New-onset impotence also developed in 3 patients with occluded IIA and 5 patients with patent IIAs. Placement of stents across the origin of the IIA may not result in immediate occlusion, but long-term patency of covered IIAs is decreased compared to uncovered IIAs. This study is limited by a small sample size, but when treating AIOD, coverage of the internal iliac origin should be avoided to maintain patency of the pelvic circulation. Copyright © 2016 Elsevier Inc. All rights reserved.

Use of Self-Expanding Metallic Ureteral Stents in the Secondary Treatment of Ureteral Stenosis Following Kidney Transplantation.

PubMed

Xu, Guibin; Li, Xun; He, Yongzhong; Zhao, Haibo; Yang, Weiqing; Xie, Qingling

2015-10-01

To evaluate the safety and efficacy of self-expanding metal stents in the treatment of ureteral stenosis following kidney transplantation. Seven patients who developed benign stenosis after kidney transplantation were treated by a self-expanding metallic stent implantation from June 2007 to March 2014. All patients had undergone at least one open surgical procedure and one endourologic procedure for treatment of the stenosis. The extent of stenosis varied from 1.2 to 3.7 cm. Ultrasonography, urography, diuretic renography, and urine culture were performed every 3 months after stent insertion. Ureteroscopic examination was performed when needed. Stent placement was technically effective in all cases. The mean operative time was 37 minutes (range, 26-59 minutes). Lower urinary-tract symptoms and the ipsilateral flank pain were common early-stage complications and were greatly relieved after an average of 3 months. The mean follow-up duration was 38 months (range, 13-86 months), and no stent migration or fragmentation was observed. Urothelial hyperplasia occurred in only one patient and was effectively managed with a Double-J stent. Five patients had normal stable renal function; the remaining two had impaired renal function, including one patient with a preoperative renal failure who required dialysis at the end of the follow-up period (36 months). As an alternative to open surgery, implantation of a self-expanding metal stent is a safe and effective treatment for ureteral stenosis in patients who have undergone kidney transplantation.

Percutaneous coronary intervention using a combination of robotics and telecommunications by an operator in a separate physical location from the patient: an early exploration into the feasibility of telestenting (the REMOTE-PCI study).

PubMed

Madder, Ryan D; VanOosterhout, Stacie M; Jacoby, Mark E; Collins, J Stewart; Borgman, Andrew S; Mulder, Abbey N; Elmore, Matthew A; Campbell, Jessica L; McNamara, Richard F; Wohns, David H

2017-01-20

The present study explores the feasibility of telestenting, wherein a physician operator performs stenting on a patient in a separate physical location using a combination of robotics and telecommunications. Patients undergoing robotic stenting were eligible for inclusion. All manipulations of guidewires, balloons, and stents were performed robotically by a physician operator located in an isolated separate room outside the procedure room housing the patient. Communication between the operating physician and laboratory personnel was via telecommunication devices providing real-time audio and video connectivity. Among 20 patients who consented to participate, technical success, defined as successful advancement and retraction of guidewires, balloons, and stents by the robotic system without conversion to manual operation, was achieved in 19 of 22 lesions (86.4%). Procedural success, defined as <30% residual stenosis upon completion of the procedure in the absence of death or repeat revascularisation prior to hospital discharge, was achieved in 19 of 20 patients (95.0%). There were no deaths or repeat revascularisations prior to hospital discharge. To the best of our knowledge, the present study is the first to explore the feasibility of telestenting. Additional studies are required to determine if future advancements in robotics will facilitate telestenting over greater geographic distances.

Outcomes of secondary self-expandable metal stents versus surgery after delayed initial palliative stent failure in malignant colorectal obstruction.

PubMed

Yoon, Jin Young; Park, Soo Jung; Hong, Sung Pil; Kim, Tae Il; Kim, Won Ho; Cheon, Jae Hee

2013-01-01

When re-intervention is required due to an occluded first colorectal self-expanding metal stent for malignant colorectal obstruction, serious controversies exist regarding whether to use endoscopic re-stenting or surgery. To compare the clinical outcomes in patients who underwent stent re-insertion versus palliative surgery as a second intervention. A total of 115 patients who received either self-expandable metal stent (SEMS) insertion or palliative surgery for treatment of a second occurrence of malignant colorectal obstruction after the first SEMS placement were retrospectively studied between July 2005 and December 2009. The median overall survival (8.2 vs. 15.5 months) and progression-free survival (4.0 vs. 2.7 months) were not significantly different between the stent and surgery groups (p = 0.895 and 0.650, respectively). The median lumen patency in the stent group was 3.4 months and that in the surgery group was 7.9 months (p = 0.003). The immediate complication rate after second stent insertion was 13.9% and late complication rate was observed in 12 of 79 (15.2%) patients. There was no mortality related to the SEMS procedure. The complication and mortality rates associated with palliative surgery were 3.5% (2/57) and 12.3% (7/57), respectively. Although there is no significant difference in the overall survival between stenting and surgery, a secondary stent insertion had a lower mortality rate despite a shorter duration of temporary colorectal decompression compared to that of palliative surgery.

Evaluation of a Bioabsorbable Self-Expandable Vein Stent-Base Made of Poly(L-lactide) In Vitro and In Vivo.

PubMed

Løvdal, Alexandra Liv Vest; Calve, Sarah; Yang, Shuo; Van Alstine, William; Binkert, Christoph A; Klausen, Kasper

2017-01-01

This study was designed to evaluate performance and tissue response to a self-expandable bioabsorbable vein stent-base cut from a tube with enhanced stiffness and strength in vitro and in vivo. A diamond-shaped stent-base was cut from a sequential biaxially strained poly(L-lactide) (PLLA) tube for optimized performance. The performance of the stent-base was evaluated in a finite element analysis model, and validation was attempted in vitro through a cyclic flat-plate compression and radial force measurement. The performance of the stent-base was tested in vivo using 3 sheep with 2 implants each for 2 and 3½ weeks, respectively. In vitro the stent-base showed an elliptical deformation but no fractures. In vivo the stent-base showed adequate radial force and no migration. All implanted stent-bases showed multiple fractures not only at the predicted stress zones but at all connecting points. Fragments of the caudal stent-base stayed in the vein wall indicating sufficient tissue coverage to avoid embolization of the fractured stent pieces, whereas fragments from the cranial device remaining were few. Neointima formation was confirmed histologically at 2 and 3½ weeks. A bioabsorbable self-expandable stent-base made from PLLA for large veins seems feasible, but over time, the PLLA used in this study appears too stiff and lacks the sufficient flexibility to move with the vena cava, causing multiple fractures.

Evaluation of a Bioabsorbable Self-Expandable Vein Stent-Base Made of Poly(l-lactide) In Vitro and In Vivo

DOE Office of Scientific and Technical Information (OSTI.GOV)

Løvdal, Alexandra Liv Vest, E-mail: alvlo@nanotech.dtu.dk; Calve, Sarah; Yang, Shuo

PurposeThis study was designed to evaluate performance and tissue response to a self-expandable bioabsorbable vein stent-base cut from a tube with enhanced stiffness and strength in vitro and in vivo.MethodsA diamond-shaped stent-base was cut from a sequential biaxially strained poly(l-lactide) (PLLA) tube for optimized performance. The performance of the stent-base was evaluated in a finite element analysis model, and validation was attempted in vitro through a cyclic flat-plate compression and radial force measurement. The performance of the stent-base was tested in vivo using 3 sheep with 2 implants each for 2 and 3½ weeks, respectively.ResultsIn vitro the stent-base showed anmore » elliptical deformation but no fractures. In vivo the stent-base showed adequate radial force and no migration. All implanted stent-bases showed multiple fractures not only at the predicted stress zones but at all connecting points. Fragments of the caudal stent-base stayed in the vein wall indicating sufficient tissue coverage to avoid embolization of the fractured stent pieces, whereas fragments from the cranial device remaining were few. Neointima formation was confirmed histologically at 2 and 3½ weeks.ConclusionA bioabsorbable self-expandable stent-base made from PLLA for large veins seems feasible, but over time, the PLLA used in this study appears too stiff and lacks the sufficient flexibility to move with the vena cava, causing multiple fractures.« less

Coronary Stents: The Impact of Technological Advances on Clinical Outcomes.

PubMed

Mennuni, Marco G; Pagnotta, Paolo A; Stefanini, Giulio G

2016-02-01

Percutaneous coronary interventions (PCI) were proposed in the late 1970s as an alternative to surgical coronary artery bypass grafting for the treatment of coronary artery disease. Important technological progress has been made since. Balloon angioplasty was replaced by bare metal stents, which allowed to permanently scaffold the coronary vessel avoiding acute recoil and abrupt occlusion. Thereafter, the introduction of early generation drug-eluting stents (DES) has significantly improved clinical outcomes, primarily by markedly reducing the risk of restenosis. New generation DES with thinner stent struts, novel durable or biodegradable polymer coatings, and new limus antiproliferative agents, have further improved upon the safety and efficacy profile of early generation DES. The present article aims to review the impact of technological advances on clinical outcomes in the field of PCI with coronary stents, and to provide a brief overview on clinical margins of improvement and unmet needs of available DES.

Transhepatic implant of a trimmed Melody™ valved stent in tricuspid position in a 1-year-old infant.

PubMed

Cools, Bjorn; Rega, Filip; Gewillig, Marc

2017-02-15

Percutaneous valved stent implantation is precluded in small infants because large delivery sheaths and large devices. We describe a procedure in a 1-year-old boy in whom a 19 mm Epic™ valve in tricuspid position had become dysfunctional. As the internal diameter of the prosthetic valve was about 16 mm, the only available valve was the Melody™ valved stent. Technical modifications were required to address issues like venous access, the bulky delivery system, and the length of the valved stent. The Melody™ valved stent was surgically trimmed and mounted on a 16 mm Tyshak balloon, access was provided transhepatically through a short 18 Fr sheath. After deployment, the intrahepatic route was sealed with two vascular plugs (8 and 10 mm) in tandem. The procedure was uncomplicated with perfect valve function 18 months after implant. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Differences in optical coherence tomographic findings and clinical outcomes between excimer laser and cutting balloon angioplasty for focal in-stent restenosis lesions.

PubMed

Nishino, Masami; Lee, Yasuharu; Nakamura, Daisuke; Yoshimura, Takahiro; Taniike, Masayuki; Makino, Nobuhiko; Kato, Hiroyasu; Egami, Yasuyuki; Shutta, Ryu; Tanouchi, Jun; Yamada, Yoshio

2012-10-01

In-stent restenosis (ISR), especially focal ISR, after percutaneous coronary intervention (PCI) remains one of the major clinical problems in the drug-eluting stent (DES) era. Several reports have revealed that excimer laser coronary angioplasty (ELCA) is useful for ISR; however, detailed findings after ELCA are unknown. Therefore, we investigated the condition of the neointima after ELCA for ISR with optical coherence tomography (OCT) and compared the OCT findings and clinical outcome between ELCA and cutting-balloon angioplasty (CBA). Twenty-one consecutive patients with focal ISR who underwent ELCA or CBA were enrolled. All patients underwent 12- to 15-month follow-up coronary angiography. OCT was performed immediately after successful PCI to evaluate the neointimal condition in the ISR lesion. We compared the following OCT parameters between ELCA and CBA groups: maximal thickness of remaining in-stent neointima (MTN), number of tears, minimum lumen dimension (MLD), and minimum lumen area (MLA). We also evaluated clinical outcomes, including target vessel revascularization, acute myocardial infarction, death, and stent thrombosis. MLA in the ELCA group (n = 10) was significantly larger than in the CBA group, and number of tears in the ELCA group was significantly lower than in the CBA group. A trend was shown toward lower TLR with ELCA versus CBA (10.0% vs 45.5%). OCT immediately after ELCA for ISR lesions revealed larger lumen area and smaller number of tears compared with CBA, which may support favorable effects of ELCA for focal ISR.

Efficacy of Retrievable Metallic Stent with Fixation String for Benign Stricture after Upper Gastrointestinal Surgery.

PubMed

Kim, Jeong-Eun; Kim, Hyo-Cheol; Lee, Myungsu; Hur, Saebeom; Kim, Minuk; Lee, Sang Hwan; Cho, Soo Buem; Kim, Chan Sun; Han, Joon Koo

2016-01-01

To determine the efficacy of retrievable metallic stent with fixation string for benign anastomotic stricture after upper gastrointestinal (UGI) surgery. From June 2009 to May 2015, a total of 56 retrievable metallic stents with fixation string were placed under fluoroscopy guidance in 42 patients who were diagnosed with benign anastomotic stricture after UGI surgery. Clinical success was defined as achieving normal regular diet (NRD). The clinical success rate after the first stent placement was 57.1% (24/42). After repeated stent placement and/or balloon dilation, the clinical success rate was increased to 83.3% (35/42). Six (14.3%) patients required surgical revision to achieve NRD. One (2.4%) patient failed to achieve NRD. Stent migration occurred in 60.7% (34/56) of patients. Successful rate of removing the stent using fixation string and angiocatheter was 94.6% (53/56). Distal migration occurred in 12 stents. Of the 12 stents, 10 (83.3%) were successfully removed whereas 2 could not be removed. No complication occurred regarding distal migration. Using retrievable metallic stent with a fixation string is a feasible option for managing early benign anastomotic stricture after UGI surgery. It can reduce complications caused by distal migration of the stent.

Efficacy of Retrievable Metallic Stent with Fixation String for Benign Stricture after Upper Gastrointestinal Surgery

PubMed Central

Kim, Jeong-Eun; Lee, Myungsu; Hur, Saebeom; Kim, Minuk; Lee, Sang Hwan; Cho, Soo Buem; Kim, Chan Sun; Han, Joon Koo

2016-01-01

Objective To determine the efficacy of retrievable metallic stent with fixation string for benign anastomotic stricture after upper gastrointestinal (UGI) surgery. Materials and Methods From June 2009 to May 2015, a total of 56 retrievable metallic stents with fixation string were placed under fluoroscopy guidance in 42 patients who were diagnosed with benign anastomotic stricture after UGI surgery. Clinical success was defined as achieving normal regular diet (NRD). Results The clinical success rate after the first stent placement was 57.1% (24/42). After repeated stent placement and/or balloon dilation, the clinical success rate was increased to 83.3% (35/42). Six (14.3%) patients required surgical revision to achieve NRD. One (2.4%) patient failed to achieve NRD. Stent migration occurred in 60.7% (34/56) of patients. Successful rate of removing the stent using fixation string and angiocatheter was 94.6% (53/56). Distal migration occurred in 12 stents. Of the 12 stents, 10 (83.3%) were successfully removed whereas 2 could not be removed. No complication occurred regarding distal migration. Conclusion Using retrievable metallic stent with a fixation string is a feasible option for managing early benign anastomotic stricture after UGI surgery. It can reduce complications caused by distal migration of the stent. PMID:27833405

Management of Transjugular Intrahepatic Portosystemic Shunt (TIPS)-associated Refractory Hepatic Encephalopathy by Shunt Reduction Using the Parallel Technique: Outcomes of a Retrospective Case Series

DOE Office of Scientific and Technical Information (OSTI.GOV)

Cookson, Daniel T., E-mail: danielthomascookson@yahoo.co.uk; Zaman, Zubayr; Gordon-Smith, James

2011-02-15

Purpose: To investigate the reproducibility and technical and clinical success of the parallel technique of transjugular intrahepatic portosystemic shunt (TIPS) reduction in the management of refractory hepatic encephalopathy (HE). Materials and Methods: A 10-mm-diameter self-expanding stent graft and a 5-6-mm-diameter balloon-expandable stent were placed in parallel inside the existing TIPS in 8 patients via a dual unilateral transjugular approach. Changes in portosystemic pressure gradient and HE grade were used as primary end points. Results: TIPS reduction was technically successful in all patients. Mean {+-} standard deviation portosystemic pressure gradient before and after shunt reduction was 4.9 {+-} 3.6 mmHg (range,more » 0-12 mmHg) and 10.5 {+-} 3.9 mmHg (range, 6-18 mmHg). Duration of follow-up was 137 {+-} 117.8 days (range, 18-326 days). Clinical improvement of HE occurred in 5 patients (62.5%) with resolution of HE in 4 patients (50%). Single episodes of recurrent gastrointestinal hemorrhage occurred in 3 patients (37.5%). These were self-limiting in 2 cases and successfully managed in 1 case by correction of coagulopathy and blood transfusion. Two of these patients (25%) died, one each of renal failure and hepatorenal failure. Conclusion: The parallel technique of TIPS reduction is reproducible and has a high technical success rate. A dual unilateral transjugular approach is advantageous when performing this procedure. The parallel technique allows repeat bidirectional TIPS adjustment and may be of significant clinical benefit in the management of refractory HE.« less

Robot-Assisted Antegrade In-Situ Fenestrated Stent Grafting

DOE Office of Scientific and Technical Information (OSTI.GOV)

Riga, Celia V., E-mail: c.riga@imperial.ac.uk; Bicknell, Colin D.; Wallace, Daniel

2009-05-15

To determine the technical feasibility of a novel approach of in-situ fenestration of aortic stent grafts by using a remotely controlled robotic steerable catheter system in the porcine model. A 65-kg pig underwent robot-assisted bilateral antegrade in-situ renal fenestration of an abdominal aortic stent graft with subsequent successful deployment of a bare metal stent into the right renal artery. A 16-mm iliac extension covered stent served as the porcine aortic endograft. Under fluoroscopic guidance, the graft was punctured with a 20-G customized diathermy needle that was introduced and kept in place by the robotic arm. The needle was exchanged formore » a 4 x 20 mm cutting balloon before successful deployment of the renal stent. Robot-assisted antegrade in-situ fenestration is technically feasible in a large mammalian model. The robotic system enables precise manipulation, stable positioning, and minimum instrumentation of the aorta and its branches while minimizing radiation exposure.« less

Pulmonary vein stenosis with collateralization via esophageal varices: Long-term follow-up after successful treatment with drug-eluting stent.

PubMed

Goldberg, Jason F; Jensen, Craig L; Krishnamurthy, Rajesh; Varghese, Nidhy P; Justino, Henri

2018-01-01

We describe the long-term follow-up of a child with recurrent hemoptysis due to severe pulmonary vein stenosis decompressing via collaterals to esophageal varices. Case report SETTING: Tertiary children's hospital PATIENT: Single child through ages 2- to 11-year old INTERVENTIONS: The child underwent cutting balloon angioplasty, bare metal stenting, and implantation of a PTFE-covered stent, all of which failed rapidly. Only after placement of a paclitaxel drug eluting stent did he have prolonged relief from hemoptysis and long-term patency of the treated vein. The stents were serially dilated to keep up with somatic growth of the child, eventually culminating in the need to induce intentional stent fracture. We highlight novel transcatheter techniques to treat this vexing condition, discuss mechanisms of disease treatment and progression, and present the only patient with this rare combination of lesions to have achieved both longstanding pulmonary vein patency and resolution of esophageal varices. © 2017 Wiley Periodicals, Inc.

'Postconditioning' the human heart: multiple balloon inflations during primary angioplasty may confer cardioprotection.

PubMed

Darling, Chad E; Solari, Patrick B; Smith, Craig S; Furman, Mark I; Przyklenk, Karin

2007-05-01

Growing evidence from experimental models suggests that relief of myocardial ischemia in a stuttering manner (i.e., 'postconditioning' [PostC] with brief cycles of reperfusion-reocclusion) limits infarct size. However, the potential clinical efficacy of PostC has, to date,been largely unexplored. Using a retrospective study design, our aim was to test the hypothesis that creatine kinase release (CK: clinical surrogate of infarct size) would be attenuated in ST-segment elevation myocardial infarction (STEMI) patients requiring multiple balloon inflations-deflations during primary angioplasty versus STEMI patients who received minimal balloon inflations and/or direct stenting. To investigate this concept, we reviewed the records of all STEMI patients with single vessel occlusion who presented to our institution from November 2004 - April 2006 for primary angioplasty. Exclusion criteria were: previous MI, cardiogenic shock, patients resuscitated from cardiac arrest, or pre-infarct angina. Patients were prospectively divided into two subsets: those receiving 1-3 balloon inflations (considered the minimum range to achieve patency and stent placement) versus those in whom 4 or more inflations were applied. Peak CK release was significantly lower in patients requiring > or =4 versus 1-3 inflations (1655 versus 2272 IU/L; p<0.05), an outcome consistent with the concept that relief of sustained ischemia in a stuttered manner (analogous to postconditioning) may evoke cardioprotection in the clinical setting.

Carotid Artery Stenting Using a Novel Self-Expanding Braided Nickel-Titanium Stent: Feasibility and Safety Porcine Trial

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ahlhelm, Frank, E-mail: frah1@gmx.de; Kaufmann, Ralf, E-mail: ralf.kaufmann@vascomed.d; Ahlhelm, Dirk, E-mail: ahlhelmd@gmx.de

We studied the deliverability and safety of a braided, self-expanding, closed-cell nickel-titanium (NiTi) stent (E-volution, Jotec GmbH, Hechingen, Germany) especially designed for the endovascular treatment of carotid artery bifurcation stenosis with special regard to in-stent stenosis and thrombosis compared with a laser-cut reference nitinol stent in a porcine model of percutaneous vascular interventions. We aimed to assess histopathologic response in minipig carotid and subclavian arteries. Eight minipigs received a total of 42 stents: 14 reference stents and 28 E-volution stents. Eleven of the E-volution stents were additionally coated with heparin. Control angiography was obtained immediately before and after vascular interventionmore » as well as 4 weeks after the procedure. Primary endpoints were 28 days of angiographic analyses as well as histomorphometric analysis, including injury score, inflammation score, luminal diameter, vessel diameter, maximal neointimal thickness, and area of in-stent stenosis. Secondary end points were procedural success, 28-day mortality, and stent thrombosis. All stents could be delivered successfully without procedural complications, morbidity, or mortality during our observation time. As confirmed by histology, no in-stent thrombosis was observed. Compared with common carotid arteries, subclavian arteries are significantly more vulnerable to developing in-stent stenosis caused by neointima proliferation (p < 0.05). Compared with the use of 1 single stent/artery, serial application of two stents leads to a more excessive but not significantly different neointimal proliferation (p > 0.05). The E-volution stent, especially when heparin coated, is in line with the comparison to the laser-cut reference stent displaying similar results of angiographic, histologic, and histomorphometric analyses (p > 0.05). Compared with the reference laser-cut stent, the self-expanding nitinol stent (E-volution) with its advanced braiding technology is feasible and safe. In our opinion, the high radial resistive force and the advanced braided design with tight stent-strut interstices may be beneficial in terms of plaque stabilization. Further studies are necessary and warranted.« less

Revascularisation versus medical treatment in patients with stable coronary artery disease: network meta-analysis

PubMed Central

Stortecky, Stefan; Stefanini, Giulio G; daCosta, Bruno R; Rutjes, Anne Wilhelmina; Di Nisio, Marcello; Siletta, Maria G; Maione, Ausilia; Alfonso, Fernando; Clemmensen, Peter M; Collet, Jean-Philippe; Cremer, Jochen; Falk, Volkmar; Filippatos, Gerasimos; Hamm, Christian; Head, Stuart; Kappetein, Arie Pieter; Kastrati, Adnan; Knuuti, Juhani; Landmesser, Ulf; Laufer, Günther; Neumann, Franz-Joseph; Richter, Dimitri; Schauerte, Patrick; Sousa Uva, Miguel; Taggart, David P; Torracca, Lucia; Valgimigli, Marco; Wijns, William; Witkowski, Adam; Kolh, Philippe; Juni, Peter

2014-01-01

Objective To investigate whether revascularisation improves prognosis compared with medical treatment among patients with stable coronary artery disease. Design Bayesian network meta-analyses to combine direct within trial comparisons between treatments with indirect evidence from other trials while maintaining randomisation. Eligibility criteria for selecting studies A strategy of initial medical treatment compared with revascularisation by coronary artery bypass grafting or Food and Drug Administration approved techniques for percutaneous revascularization: balloon angioplasty, bare metal stent, early generation paclitaxel eluting stent, sirolimus eluting stent, and zotarolimus eluting (Endeavor) stent, and new generation everolimus eluting stent, and zotarolimus eluting (Resolute) stent among patients with stable coronary artery disease. Data sources Medline and Embase from 1980 to 2013 for randomised trials comparing medical treatment with revascularisation. Main outcome measure All cause mortality. Results 100 trials in 93 553 patients with 262 090 patient years of follow-up were included. Coronary artery bypass grafting was associated with a survival benefit (rate ratio 0.80, 95% credibility interval 0.70 to 0.91) compared with medical treatment. New generation drug eluting stents (everolimus: 0.75, 0.59 to 0.96; zotarolimus (Resolute): 0.65, 0.42 to 1.00) but not balloon angioplasty (0.85, 0.68 to 1.04), bare metal stents (0.92, 0.79 to 1.05), or early generation drug eluting stents (paclitaxel: 0.92, 0.75 to 1.12; sirolimus: 0.91, 0.75 to 1.10; zotarolimus (Endeavor): 0.88, 0.69 to 1.10) were associated with improved survival compared with medical treatment. Coronary artery bypass grafting reduced the risk of myocardial infarction compared with medical treatment (0.79, 0.63 to 0.99), and everolimus eluting stents showed a trend towards a reduced risk of myocardial infarction (0.75, 0.55 to 1.01). The risk of subsequent revascularisation was noticeably reduced by coronary artery bypass grafting (0.16, 0.13 to 0.20) followed by new generation drug eluting stents (zotarolimus (Resolute): 0.26, 0.17 to 0.40; everolimus: 0.27, 0.21 to 0.35), early generation drug eluting stents (zotarolimus (Endeavor): 0.37, 0.28 to 0.50; sirolimus: 0.29, 0.24 to 0.36; paclitaxel: 0.44, 0.35 to 0.54), and bare metal stents (0.69, 0.59 to 0.81) compared with medical treatment. Conclusion Among patients with stable coronary artery disease, coronary artery bypass grafting reduces the risk of death, myocardial infarction, and subsequent revascularisation compared with medical treatment. All stent based coronary revascularisation technologies reduce the need for revascularisation to a variable degree. Our results provide evidence for improved survival with new generation drug eluting stents but no other percutaneous revascularisation technology compared with medical treatment. PMID:24958153

[Brainstem auditory evoked potentials in neurophysiological assessment of brain stem dysfunction in patients with atherostenosis of vertebral arteries].

PubMed

Maksimova, M Yu; Sermagambetova, Zh N; Skrylev, S I; Fedin, P A; Koshcheev, A Yu; Shchipakin, V L; Sinicyn, I A

To assess brain stem dysfunction in patients with hemodynamically significant stenosis of vertebral arteries (VA) using short latency brainstem auditory evoked potentials (BAEP). The study group included 50 patients (mean age 64±6 years) with hemodynamically significant extracranial VA stenosis. Patients with hemodynamically significant extracranial VA stenosis had BAEP abnormalities including the elongation of interpeak intervals I-V and peak V latency as well as the reduction of peak I amplitude. After transluminal balloon angioplasty with stenting of VA stenoses, there was a shortening of peak V latency compared to the preoperative period that reflected the improvement of brain stem conductive functions. Atherostenosis of vertebral arteries is characterized by the signs of brain stem dysfunction, predominantly in the pontomesencephal brain stem. After transluminal balloon angioplasty with stenting of VA, the improvement of brain stem conductive functions was observed.

Number of Blades-up Runs Using JetStream XC Atherectomy for Optimal Tissue Debulking in Patients with Femoropopliteal Artery In-Stent Restenosis.

PubMed

Shammas, Nicolas W; Shammas, Gail A; Aasen, Nicole; Jarvis, Gary

2015-12-01

Rotational atherectomy with the use of the JetStream XC device is indicated for treatment of infrainguinal arterial obstructive disease. The number of blades-up (BU) runs needed for optimal tissue debulking in femoropopliteal in-stent restenosis (ISR) is unknown. In the present series, 6 patients (15 lesions) were treated for femoropopliteal ISR with the JetStream XC device. Minimal luminal diameter or percent stenosis improved significantly from baseline after 2 BU runs, but no further gain was seen between 2 and 4 BU runs (P > .05). However, adjunctive balloon angioplasty reduced percent stenosis significantly following BU runs. In conclusion, the JetStream XC device achieved optimal acute angiographic results in treating femoropopliteal ISR following 2 BU runs and adjunctive balloon angioplasty. Copyright © 2015 SIR. Published by Elsevier Inc. All rights reserved.

The 'MAP strategy' (Maximum aspiration of atherothrombus and adjunctive glycoprotein IIb/IIIa inhibitor utilization combined with prolonged inflation of balloon/stent) for preventing no-reflow in patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention: A retrospective analysis of seventy-one cases.

PubMed

Potdar, Anil; Sharma, Satyavan

2015-12-01

'No-reflow' phenomenon is a common occurrence in percutaneous coronary intervention (PCI). A three-component 'MAP strategy' was designed to prevent no-reflow by addressing both intralesional and intraluminal thrombus in patients with ST-segment elevation myocardial infarction (STEMI). In this analysis, we observed Thrombolysis In Myocardial Infarction (TIMI) flow grade 3 or 2 in all patients, with no incidence of no-reflow. Myocardial blush grade (MBG) 3 or 2 was observed in most (87.32%) patients. Left ventricular ejection fraction (LVEF) was improved, without any incidence of death up to 9-month follow-up. All patients safely tolerated the strategy-driven prolonged, 35-s inflation of the balloon/stent. Copyright © 2016. Published by Elsevier B.V.

Drug coated balloon in peripheral artery disease.

PubMed

Shanmugasundaram, Madhan; Murugapandian, Sangeetha; Truong, Huu Tam; Lotun, Kapildeo; Banerjee, Subhash

2018-04-21

Peripheral artery disease (PAD) is highly prevalent but is often underdiagnosed and undertreated. Lower extremity PAD can often be life style limiting. Revascularization in carefully selected lower extremity PAD patients improves symptoms and functional status. Surgical revascularization used to be the only available strategy, but in the recent years, endovascular strategies have gained popularity due to faster recovery times with low morbidity and mortality rates. Endovascular procedures have increased significantly in the United States in the past few years. That being said, higher restenosis rates and low long-term patency rates have been the limiting factors for this strategy. Drug eluting stents have been introduced to help with lowering restenosis, however lower extremity PAD involves long segment where the outcomes of stents are suboptimal. Also, the disease often crosses joint line that makes it less ideal for the stents. Drug coated balloons (DCB) have been introduced to improve patency rates following endovascular intervention for lower extremity PAD. They have gained popularity among endovascular specialists due to its ease of use and the concept of "leave nothing behind". This is a review of scientific evidence supporting DCB use in PAD. Published by Elsevier Inc.

Transtracheal single-point stent fixation in posttracheotomy tracheomalacia under cone-beam computer tomography guidance by transmural suturing with the Berci needle – a perspective on a new tool to avoid stent migration of Dumon stents

PubMed Central

Hohenforst-Schmidt, Wolfgang; Linsmeier, Bernd; Zarogoulidis, Paul; Freitag, Lutz; Darwiche, Kaid; Browning, Robert; Turner, J Francis; Huang, Haidong; Li, Qiang; Vogl, Thomas; Zarogoulidis, Konstantinos; Brachmann, Johannes; Rittger, Harald

2015-01-01

Tracheomalacia or tracheobronchomalacia (TM or TBM) is a common problem especially for elderly patients often unfit for surgical techniques. Several surgical or minimally invasive techniques have already been described. Stenting is one option but in general long-time stenting is accompanied by a high complication rate. Stent removal is more difficult in case of self-expandable nitinol stents or metallic stents in general in comparison to silicone stents. The main disadvantage of silicone stents in comparison to uncovered metallic stents is migration and plugging. We compared the operation time and in particular the duration of a sufficient Dumon stent fixation with different techniques in a patient with severe posttracheotomy TM and strongly reduced mobility of the vocal cords due to Parkinson’s disease. The combined approach with simultaneous Dumon stenting and endoluminal transtracheal externalized suture under cone-beam computer tomography guidance with the Berci needle was by far the fastest approach compared to a (not performed) surgical intervention, or even purely endoluminal suturing through the rigid bronchoscope. The duration of the endoluminal transtracheal externalized suture was between 5 minutes and 9 minutes with the Berci needle; the pure endoluminal approach needed 51 minutes. The alternative of tracheobronchoplasty was refused by the patient. In general, 180 minutes for this surgical approach is calculated. The costs of the different approaches are supposed to vary widely due to the fact that in Germany 1 minute in an operation room costs on average approximately 50–60€ inclusive of taxes. In our own hospital (tertiary level), it is nearly 30€ per minute in an operation room for a surgical approach. Calculating an additional 15 minutes for patient preparation and transfer to wake-up room, therefore a total duration inside the investigation room of 30 minutes, the cost per flexible bronchoscopy is per minute on average less than 6€. Although the Dumon stenting requires a set-up with more expensive anesthesiology accompaniment, which takes longer than a flexible investigation estimated at 1 hour in an operation room, still without calculation of the costs of the materials and specialized staff that the surgical approach would consume at least 3,000€ more than a minimally invasive approach performed with the Berci needle. This difference is due to the longer time of the surgical intervention which is calculated at approximately 180 minutes in comparison to the achieved non-surgical approach of 60 minutes in the operation suite. PMID:26045666

A Novel Self-Expandable, Radioactive Airway Stent Loaded with 125I Seeds: A Feasibility and Safety Study in Healthy Beagle Dog.

PubMed

Wang, Yong; Guo, Jin-He; Zhu, Guang-Yu; Zhu, Hai-Dong; Chen, Li; Lu, Jian; Wang, Chao; Teng, Gao-Jun

2017-07-01

Airway stent placement is an effective treatment for the immediate palliation of malignant airway obstruction. However, restenosis caused by tumor ingrowth and/or overgrowth after stenting is common. The purpose of this study was to investigate the feasibility and safety of a novel self-expandable stent loaded with 125 I seeds in healthy beagle dog. Under fluoroscopic guidance, forty-eight self-expandable airway stents loaded with 125 I seeds were perorally placed in the main trachea of 48 healthy beagle dogs, who were randomly divided into four groups (Group A: 0.3 mCi; Group B: 0.6 mCi; Group C: 0.9 mCi; Control group: 0 mCi). The estimated radiation dose was calculated using the isotropic point source approximation. Radiological follow-up examinations and histopathological examinations of stented tracheal segments and their adjacent organs and tissues were performed at 2, 4, 8, and 16 weeks following the stenting. All stents were successfully deployed in the targeted tracheal segment in the beagle dogs without procedure-related complications. Tracheal stenosis became severe gradually in all the four groups, which was not associated with the radioactivity of 125 I seeds (p > 0.05). The tracheal injury scores increased along with the higher dose of radioactive seeds which reached peak at 8 weeks and then turned back slightly at 16 weeks. The adjacent tissue did not show pathohistological changes under microscope, while mild and reversible ultrastructure changes were showed under electronic microscope. This study demonstrates that it is feasible and safe to insert this novel self-expandable airway stent loaded with 125 I seeds in healthy beagle dog.

[Membrane-covered self-expanding stents in the treatment of high-positioned esophageal stenosis or fistula].

PubMed

Liu, Jing-zheng; Zhong, Yun-shi; Xu, Mei-dong; Chen, Wei-feng; Zhou, Ping-hong; Yao, Li-qing

2013-12-01

To investigate the efficacy and safety of membrane-covered self-expanding metal stent in the treatment of high-positioned esophageal diseases, including esophageal stenosis, esophagotracheal fistula and anastomotic stricture. Clinical data of 84 patients who underwent stenting in our center from May 2005 to July 2013 were retrospectively analyzed. Of 84 patients, 31 were diagnosed as esophageal malignant stenosis, 2 compression stenosis, 10 radiation stenosis, 4 recurrent malignant stenosis, 27 anastomotic stricture, 1 esophageal stenosis after endoscopic submucosal dissection (ESD), 7 esophageal-tracheal fistula, 1 esophageal-mediastinal fistula, and 1 remnant stomach fistula. Distance from stenosis or fistula to central incisor was 15-20 cm in 48 cases, and more than 20 cm in 36 cases. All the patients were treated by 16 mm membrane-covered self-expanding metal stents. Main clinical manifestations and complications were evaluated. A total of 100 stents were placed in 84 patients,with a success rate of 100%. There were no complications such as perforation and bleeding during operation. Dysphagia and cough were improved quickly with a success rate of 100%. After the placement of stents, the incidence of complication was 6.0% (5/84), of which 2 cases were severe retrosternal pain, 1 was tracheal collapse, and 2 were stent displacement. Seventy-six patients (90.5%) received complete follow-up of 1 to 36 months (mean 15 months). Re-stenosis occurred in 4 cases, new esophageal-tracheal fistula in 2 cases. Among these 6 cases, 5 cases underwent successfully stent placement once again, and another one case received Savary bougie and Argon-ion coagulation with good efficacy. Endoscopic membrane-covered self-expanding metal stent placement is effective and safe for the relieve of dysphagia symptoms and the sealing of esophagotracheal fistula.

Clinical Application of Fully Covered Self-Expandable Metal Stents in the Treatment of Bronchial Fistula.

PubMed

Cao, Ming; Zhu, Qiang; Wang, Wei; Zhang, Tian Xiao; Jiang, Min Zhong; Zang, Qi

2016-09-01

Background The study was designed to access the feasibility, safety, and efficacy of fully covered self-expandable metal stents in the treatment of bronchial fistula. Methods Clinical data of nine patients (seven males and two females) who were treated with placement of tracheobronchial or bronchial fully covered self-expandable metal stents from August 2005 to November 2011 were analyzed retrospectively. Among these patients, seven were diagnosed with bronchopleural fistula, one with tracheopleural fistula, and one with left main bronchoesophageal fistula. Eight had accompanying thoracic empyema. The fistula orifices ranged from 3.5 mm to 25 mm in diameter. All patients received topical anesthesia. L-shaped stents were placed in six patients and I-shaped stents in three under fluoroscopic guidance. After stent placement, patients with empyema were treated with pleural lavage. Results Stent placement in the tracheobronchial tree was successful in all patients, without procedure-related complications. The operating time was 5 to 16 minutes. A small amount of bubble overflowed from the intrathoracic drainage tube of only one patient. In the other patients, the bubble in the intrathoracic drainage tube disappeared immediately or angiography showed no overflow of contrast agent from the fistula orifice. The effective rate of fistula orifice closure after stent placement was 100%, with 88.9% rated as excellent. One patient coughed the stent out 5 days after placement and hence a new stent was placed. Among the patients with empyema, one died of septicemia arising from empyema on day 8 and another died of brain metastases of lung cancer 6 months after stent insertion with persistent empyema. In the other six patients, empyema resolved after 2 to 5 months (cure rate 75%). Seven patients were followed up for 3 to 36 months. During follow-up, one stent was removed 8 months after implantation due to difficult expectoration, without recurrent empyema. The remaining patients tolerated the stents well. The stents remained stable without migration or empyema recurrence, and they could eat and drink well. Conclusion The use of fully covered self-expandable metal stents is a safe, effective, and fast minimally invasive method to treat bronchial fistula, especially for selected cases with empyema. Georg Thieme Verlag KG Stuttgart · New York.

Polyflex expandable stents in the treatment of esophageal disease: initial experience.

PubMed

Pennathur, Arjun; Chang, Andrew C; McGrath, Kevin M; Steiner, Gregory; Alvelo-Rivera, Miguel; Awais, Omar; Gooding, William E; Christie, Neil A; Gilbert, Sebastien; Landreneau, Rodney J; Luketich, James D

2008-06-01

The new generation of expandable plastic esophageal stents (Polyflex; Boston Scientific, Natick, MA), combine the features of plastic and self-expanding metallic stents. The main objective of this study is to evaluate our initial experience with Polyflex expandable stents in the treatment of esophageal disease from two institutions. A total of 58 Polyflex stents were placed in 38 patients over a two-year period. There were 24 men and 14 women, with a median age of 63 years (range, 25 to 83). The most common indication for placement was an esophageal stricture in 25 patients (66%); other causes included leak in 8 (21%) and tracheoesophageal fistula (TEF) in 5 (13%). We evaluated the hospital course, complications, and outcomes. The median postoperative stay was one day. Complications included migration in 38 stents (63%) (28 patients; 73%), retrosternal chest discomfort in nine, reflux in four, airway obstruction in one, and food impaction in three. Continued leak or a persistent TEF occurred in five patients (38%). Reintervention was required predominantly due to migration of the stent at a mean interval of 46 days (range, 1 to 353). Patients with dysphagia improved significantly with dysphagia scores (1 = no dysphagia; 5 = unable to swallow saliva) improving from 3.44 to 2.15 (p < 0.0001). Polyflex stents were effective in the relief of dysphagia due to strictures. They were less effective in esophageal perforations or leaks. Their primary disadvantage is a high migration rate and further improvements in design are required to decrease this high incidence of migration.

Comparative Computed Flow Dynamic Analysis of Different Optimization Techniques in Left Main Either Provisional or Culotte Stenting.

PubMed

Rigatelli, Gianluca; Dell'Avvocata, Fabio; Zuin, Marco; Giatti, Sara; Duong, Khanh; Pham, Trung; Tuan, Nguyen Si; Vassiliev, Dobrin; Daggubati, Ramesh; Nguyen, Thach

2017-12-01

Provisional and culotte are the most commonly used techniques in left main (LM) stenting. The impact of different post-dilation techniques on fluid dynamic of LM bifurcation has not been yet investigated. The aim of this study is to evaluate, by means of computational fluid dynamic analysis (CFD), the impact of different post-dilation techniques including proximal optimization technique (POT), kissing balloon (KB), POT-Side-POT and POT-KB-POT, 2-steps Kissing (2SK) and Snuggle Kissing balloon (SKB) on flow dynamic profile after LM provisional or culotte stenting. We considered an LM-LCA-LCX bifurcation reconstructed after reviewing 100 consecutive patients (mean age 71.4 ± 9.3 years, 49 males) with LM distal disease. The diameters of LAD and LCX were modelled according to the Finnet's law as following: LM 4.5 mm, LAD 3.5 mm, LCX 2.75 mm, with bifurcation angle set up at 55°. Xience third-generation stent (Abbot Inc., USA) was reconstructed and virtually implanted in provisional/cross-over and culotte fashion. POT, KB, POT-side-POT, POT-KB-POT, 2SK and SKB were virtually applied and analyzed in terms of the wall shear stress (WSS). Analyzing the provisional stenting, the 2SK and KB techniques had a statistically significant lower impact on the WSS at the carina, while POT seemed to obtain a neutral effect. In the wall opposite to the carina, the more physiological profile has been obtained by KB and POT with higher WSS value and smaller surface area of the lower WSS. In culotte stenting, at the carina, POT-KB-POT and 2SK had a very physiological profile; while at the wall opposite to the carina, 2SK and POT-KB-POT decreased significantly the surface area of the lower WSS compared to the other techniques. From the fluid dynamic point of view in LM provisional stenting, POT, 2SK and KB showed a similar beneficial impact on the bifurcation rheology, while in LM culotte stenting, POT-KB-POT and 2SK performed slightly better than the other techniques, probably reflecting a better strut apposition.

Hepatocellular Carcinoma Complicated by Gastroduodenal Obstruction: Palliative Treatment with Metallic Stent Placement

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lee, Ye Jin; Kim, Jin Hyoung, E-mail: m1fenew@daum.net; Song, Ho-Young

Purpose: To evaluate the clinical effectiveness of self-expandable metallic stents in seven patients with malignant gastroduodenal obstruction caused by inoperable hepatocellular carcinoma (HCC). Methods: Seven patients with gastroduodenal obstruction caused by advanced HCC underwent metallic stent placement from 2003 to 2010. These patients had total dysphagia (n = 5) or were able to eat only liquids (n = 2) before stent placement. Patients had Eastern Cooperative Oncology Group performance scores of 2 or 3, and Child-Pugh classification B or C. Results: Stent placement was technically successful in all seven patients (100%) and clinically successful in six (86%). Five patients couldmore » eat a soft diet, and one patient tolerated regular diet after stent placement. Stent-related obstructive jaundice occurred in one patient. One patient had hematemesis 11 days after stent placement. Overall mean survival was 51 days (range, 10-119 days). Stent patency was preserved in six patients with clinical success until death. Conclusion: Placement of a covered self-expandable metallic stent may offer good palliation in patients with gastroduodenal obstruction due to advanced HCC.« less

Management of postoperative esophageal leaks with the Polyflex self-expanding covered plastic stent.

PubMed

Langer, Felix B; Wenzl, Etienne; Prager, Gerhard; Salat, Andreas; Miholic, Johannes; Mang, Thomas; Zacherl, Johannes

2005-02-01

Esophageal anastomotic leaks can lead to prolonged hospitalization. In this article we present our experience with the placement of the Polyflex self-expanding plastic stent (Willy Ruesch GMBH, Kernen, Germany) for leak occlusion. Between April 2000 and November 2003, 24 patients were included into this prospective study and underwent Polyflex stent placement for postoperative esophageal anastomotic leaks. The primary operation was esophagectomy in 13 patients, gastrectomy in 7, cardia resection in 2, and other procedures in 2 patients. The median interval between operation and stent placement was 19 days (range, 4 to 65). The effectiveness of leak occlusion was evaluated by water-soluble contrast swallow and the clinical course. In 2 patients stent misplacement produced an enlarged anastomotic dehiscence that necessitated reoperation. Radiologic evaluation was impossible in 4 patients because of their generally restricted condition. Among 18 evaluable patients, leak occlusion was successful with a single stent in 16 patients (89%) based on radiologic evaluation. Immediate oral feeding was well tolerated by these patients. After a median follow-up of 220 days (range, 7 to 1221), 9 cases of late stent dislocation were observed. Stent removal in patients after esophagectomy with gastric pull-up led to dysphagia from anastomotic strictures in 2 patients. Symptomatic strictures did not develop in the 5 evaluable postgastrectomy patients after stent removal. The placement of self-expanding plastic stents is a highly effective treatment for esophageal anastomotic leaks. Because clinically-relevant anastomotic strictures can be expected, we do not recommend stent removal after esophagectomy with gastric pull-up reconstruction.

Expandable metal stents for endoscopic bilateral stent-within-stent placement for malignant hilar biliary obstruction.

PubMed

Chahal, Prabhleen; Baron, Todd H

2010-01-01

Placement of biliary stents is effective for palliation of unresectable hilar malignant biliary obstruction. However, when bilateral self-expandable metal stents (SEMSs) are used, placement can be technically challenging. In many studies, side-by-side placement is performed, although it is unclear whether this is the most anatomical and functional approach. We sought to assess the technical feasibility and effectiveness of deploying bilateral SEMSs with a stent-within-stent approach using commercially available stents with a large cell width. Retrospective study. Tertiary care medical center. Patients with malignant biliary hilar obstruction referred for endoscopic palliation of obstructive jaundice. Technical success, ie, successful bilateral SEMS placement across the stricture; functional success, ie, decrease in pretreatment bilirubin level; early and late complications; and stent patency. Bilateral biliary drainage was attempted and successfully established in 21 patients with malignant hilar obstruction (15 men, 6 women; mean age 63.7 [standard deviation 13.9] years), resulting in clinical improvement of obstructive symptoms. Median follow-up was 6.14 months (interquartile range 3.5-9.5 months). There were 1 (5%) early and 7 (33%) late stent occlusions that required endoscopic reintervention. The 30-day mortality rate was 10% (2 deaths). Retrospective study of a series of cases treated at a tertiary care center by expert endoscopists. This simple technique was performed by using an open-cell expandable metal stent is technically feasible and easy and allows bilateral placement of SEMSs in patients with unresectable hilar malignancy. 2010 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

Histological Evaluation of a Self-Expanding Stent-Graft 23 Months After Implantation in the Superficial Femoral Artery.

PubMed

Ishihara, Takayuki; Iida, Osamu; Inoue, Katsumi; Fujita, Masashi; Masuda, Masaharu; Okamoto, Shin; Nanto, Kiyonori; Kanda, Takashi; Tsujimura, Takuya; Sunaga, Akihiro; Mano, Toshiaki; Uematsu, Masaaki

2017-10-01

To report histological examination of a Viabahn stent-graft implanted in the superficial femoral artery (SFA) for nearly 2 years. A 78-year-old man with peripheral artery disease was treated successfully with a 6.0×250-mm Viabahn self-expanding stent-graft in the right SFA, relieving his lower limb claudication. The patient died suddenly due to acute myocardial infarction 23 months later. Histological evaluation of the stent-graft implantation site revealed moderate neointimal proliferation at both proximal and distal edges of the device. In the middle part of the stent, significant macrophages and multinucleated foreign body giant cells had accumulated, although the stent was entirely patent. Furthermore, no endothelial cell coverage was found. Judging from these features, it might be necessary to continue dual antiplatelet therapy after stent-graft implantation over the long term to prevent thrombosis and subsequent restenosis or reocclusion.

Managing malignant biliary obstruction in pancreas cancer: Choosing the appropriate strategy

PubMed Central

Boulay, Brian R; Parepally, Mayur

2014-01-01

Most patients with pancreatic cancer develop malignant biliary obstruction. Treatment of obstruction is generally indicated to relieve symptoms and improve morbidity and mortality. First-line therapy consists of endoscopic biliary stent placement. Recent data comparing plastic stents to self-expanding metallic stents (SEMS) has shown improved patency with SEMS. The decision of whether to treat obstruction and the means for doing so depends on the clinical scenario. For patients with resectable disease, preoperative biliary decompression is only indicated when surgery will be delayed or complications of jaundice exist. For patients with locally advanced disease, self-expanding metal stents are superior to plastic stents for long-term patency. For patients with advanced disease, the choice of metallic or plastic stent depends on life expectancy. When endoscopic stent placement fails, percutaneous or surgical treatments are appropriate. Endoscopic therapy or surgical approach can be used to treat concomitant duodenal and biliary obstruction. PMID:25071329

Management of post-gastrectomy anastomosis site obstruction with a self-expandable metallic stent.

PubMed

Cha, Ra Ri; Lee, Sang Soo; Kim, Hyunjin; Kim, Hong Jun; Kim, Tae-Hyo; Jung, Woon Tae; Lee, Ok Jae; Bae, Kyung Soo; Jeong, Sang-Ho; Ha, Chang Yoon

2015-04-28

Post-gastrectomy anastomosis site obstruction is a relatively rare complication after a subtotal gastrectomy. We present a case of a 75-year-old man who underwent a truncal vagotomy, omental patch, gastrojejunostomy, and Braun anastomosis for duodenal ulcer perforation and a gastric outlet obstruction. Following the 10(th) postoperative day, the patient complained of abdominal discomfort and vomiting. We diagnosed post-gastrectomy anastomosis site obstruction by an upper gastrointestinal series and an upper endoscopic examination. We inserted a self-expandable metallic stent (SEMS) at the anastomosis site. The stent was fully expanded after deployment. On the day following the stent insertion, the patient began to eat, and his abdominal discomfort was resolved. This paper describes the successful management of post-gastrectomy anastomosis site obstruction with temporary placement of a SEMS.

Food impaction after expandable metal stent placement: experience in 1,360 patients with esophageal and upper gastrointestinal tract obstruction.

PubMed

Song, Min; Song, Ho-Young; Kim, Jin Hyoung; Park, Jung-Hoon; Jung, Hwoon-Yong; Kim, Jong-Hoon; Kim, Sung-Bae

2011-09-01

To retrospectively evaluate the incidence, predictive factors, and interventional management of food impaction after expandable metallic stent placement in patients with obstruction of the esophagus or upper gastrointestinal tract caused by benign or malignant disease. Between March 1993 and March 2010, 1,360 patients (1,029 men, 331 women; age range, 21-89 y; mean age, 61 y) underwent fluoroscopically guided stent placement for dysphagia caused by esophageal or gastrointestinal tract strictures. Five types of covered expandable metal stents were used, including four types of esophageal stents (types A-D) and one type of gastroduodenal stent (type E), with types A, B, C, D, and E stents used in 180, 60, 90, 432, and 598 patients, respectively. Multivariate analysis was performed to evaluate factors predictive of food impaction. Food impaction occurred in 41 of 1,360 patients (3.0%). The food impaction rates for types A, B, C, D, and E stents were 0.6%, 1.7%, 1.1%, 3.2%, and 4.0%, respectively. Multivariate analysis showed that stent length was an independent predictor of food impaction (odds ratio, 0.839; P = .012). Of the 41 patients with food impaction, 23 underwent endoscopic management, 12 underwent fluoroscopically guided management, and six did not require management because impacted food spontaneously passed through the stent. The overall food impaction rate was 3.0%, with multiple logistic regression analysis showing that shorter stent length was the only significant predictor of food impaction. Food impaction can be managed by endoscopic or fluoroscopically guided removal or placement of a second stent. Copyright © 2011 SIR. Published by Elsevier Inc. All rights reserved.

Polyflex self-expanding, removable plastic stents: assessment of treatment efficacy and safety in a variety of benign and malignant conditions of the esophagus.

PubMed

Karbowski, M; Schembre, D; Kozarek, R; Ayub, K; Low, D

2008-05-01

Historically, esophageal fistulas, perforations, and benign and malignant strictures have been managed surgically or with the placement of permanent endoprostheses or metallic stents. Recently, a removable, self-expanding, plastic stent has become available. The authors investigated the use of this new stent at their institution. The study reviewed all the patients who received a Polyflex stent for an esophageal indication at the authors' institution between January 2004 and October 2006. Duration of placement, complications, and treatment efficacy were recorded. A total of 37 stents were placed in 30 patients (14 women and 16 men) with a mean age of 68 years (range, 28-92 years). Stent placement included 7 for fistulas, 3 for perforations, 1 for an anastomotic leak, 7 for malignant strictures, and 19 for benign strictures (8 anastomotic, 1 caustic, 5 reflux, 2 radiation, and 2 autoimmune esophagitis strictures, and 1 post-Nissen gas bloat stricture). The mean follow-up period was 6 months. Stent deployment was successful for all the patients, and no complications resulted from stent placement or removal. Nine stents migrated spontaneously. Three of three perforations and three of five fistulas sealed. Only one stent was removed because of patient discomfort. One patient with a radiation stricture experienced tracheoesophageal fistulas secondary to pressure necrosis. Of 20 patients with stricture, 18 experienced improvement in their dysphagia. Self-expanding, removable plastic stents are easily and safely placed and removed from the esophagus. This has facilitated their use in the authors' institution for an increasing number of esophageal conditions. Further studies to help define their ultimate role in benign and malignant esophageal pathology are warranted.

Iatrogenic left main coronary artery dissection due to pin-hole balloon rupture: Not to be panicked….

PubMed

Jeyakumaran, Balakumaran; Raj, Ajay; Pandit, Bhagya Narayan; Kumar, Tarun; Deora, Surender

2015-12-01

Iatrogenic left main coronary artery (LMCA) dissection is a rare complication and may have devastating consequences if not immediately intervened. The management includes urgent revascularization mostly with percutaneous coronary intervention (PCI) with bail-out stenting and rarely requires coronary artery bypass graft (CABG) surgery. In clinically and hemodynamically stable patients, a conservative approach may be preferred. Here, we present a rare case of iatrogenic retrograde LMCA dissection due to pin-hole rupture of angioplasty balloon that was managed conservatively.

Safety of six-month dual antiplatelet therapy after second-generation drug-eluting stent implantation: OPTIMA-C Randomised Clinical Trial and OCT Substudy.

PubMed

Lee, Byoung-Kwon; Kim, Jung-Sun; Lee, Oh-Huyn; Min, Pil-Ki; Yoon, Young-Won; Hong, Bum-Kee; Shin, Dong-Ho; Kang, Tae-Soo; Kim, Byung Ok; Cho, Duk-Kyu; Jeon, Dong Woon; Woo, Sung-Ill; Choi, Seonghoon; Kim, Yong Hoon; Kang, Woong-Chol; Kim, Seunghwan; Kim, Byeong-Keuk; Hong, Myeong-Ki; Jang, Yangsoo; Kwon, Hyuck Moon

2018-03-20

There are few randomised studies concerning the optimal duration of dual antiplatelet therapy (DAPT) for patients who receive a second-generation drug-eluting stent (DES). This trial aimed to investigate the safety of six-month compared with 12-month DAPT maintenance after second-generation DES implantation. A prospective, randomised, multicentre trial was performed at 10 medical centres. The 1,368 patients included in the study received a biolimus-eluting stent (BES) or a zotarolimus-eluting stent (ZES). The primary outcome measured was the composite of major adverse cardiac events (MACE), including cardiac death, myocardial infarction (MI), or ischaemia-driven target lesion revascularisation at the 12-month follow-up. The secondary outcome was the percentage of uncovered struts at six months in 60 patients (30 ZES, 30 BES) using optical coherence tomography (OCT) assessment. Each patient was randomly assigned to six-month (n=684) or 12-month DAPT (n=684). Major adverse cardiac events at 12 months occurred in eight patients (1.2%) in the six-month DAPT group and in four patients (0.6%) in the 12-month DAPT group (risk difference 0.6%; 95% confidence interval [CI]: -0.4-1.6%; p=0.24). The upper 95% CI limit was lower than the pre-specified limit of 4% non-inferiority (p for non-inferiority <0.05). The percentage of uncovered struts was 3.16±4.30% at six months in 60 stents of 60 patients. After second-generation DES implantation, six-month DAPT was not inferior to 12-month DAPT in terms of MACE occurrence over the 12-month follow-up period. OCT examination revealed favourable stent strut coverage at six months after stent implantation.

Nitinol Esophageal Stents: New Designs and Clinical Indications

DOE Office of Scientific and Technical Information (OSTI.GOV)

Strecker, Ernst-Peter; Boos, Irene; Vetter, Sylvia

1996-11-15

Purpose: To evaluate the clinical use of covered and noncovered, knitted nitinol stents in patients presenting new stent indications. Methods: Self-expandable, knitted nitinol stents were implanted in four patients for treatment of dysphagia. In two patients who had malignant strictures and had esophago-respiratory fistulae and in one patient with an esophagocutaneous fistula, polytetrafluoroethylene (PTFE)-covered stents were implanted. One patient received a noncovered stent, but a retrograde approach through a percutaneous endoscopic gastrostomy (PEG) fistula had to be chosen for recanalization of an esophageal occlusion. Two patients received stents for treatment of benign strictures. Results: Recanalization of the stricture and stentmore » implantation were performed under fluoroscopic control without any procedure-related morbidity or mortality. Dysphagia improved in all patients and the esophageal fistulae could be sealed off by covered stents. During a maximum follow-up of 18 months, there was no stent migration or esophageal perforation. Complications observed were stent stenosis due to food impaction (1/4) and benign stent stenosis (2/2). Most complications could be treated by the interventional radiologist. Conclusion: Self-expandable, covered Nitinol stents provide an option for the treatment of dysphagia combined with esophageal fistulae. In combination with interventional radiology techniques, even complex strictures are accessible. For benign strictures, the value of stent treatment has not yet been proven.« less

An intriguing design concept to enhance the pulsatile fatigue life of self-expanding stents.

PubMed

Hsiao, Hao-Ming; Yin, Ming-Ting

2014-02-01

Intravascular stenting has emerged as the primary treatment for vascular diseases and has received great attention from the medical community since its introduction two decades ago. The endovascular self-expanding stent is used to treat peripheral artery diseases; however, once implanted, these stents suffer from various cyclic motions caused by pulsatile blood pressure and daily activities. Due to this challenging environment, fatigue performance has become a critical issue for stent design. In this paper, a simple yet intriguing concept of stent design aimed at enhancing pulsatile fatigue life is investigated. The concept of this design is to shift the highly concentrated stresses/strains away from the crown and re-distribute them along the stress-free bar arm by tapering its strut width. Finite element models were developed to evaluate the mechanical integrity and pulsatile fatigue resistance of the stent to various loading conditions. Results show that the fatigue safety factor jumped to 2.5-3.0 times that of the standard stent with constant strut width. This is astonishing considering that the stent profile and scaffolding were not compromised. The findings of this paper provide an excellent approach to the optimization of future stent design to greatly improve stent fatigue performance.

Rare Esophageal Migration of AXIOS Stent Used for Walled-off Pancreatic Necrosis Drainage

PubMed Central

Renno, Anas; Hammad, Tariq; Nawras, Ali

2017-01-01

The AXIOS stent (Boston Scientific, Marlborough, MA) is a novel lumen-apposing self-expandable metallic stent designed for enteric drainage of nonadherent lumens. Efficacy and safety of using the AXIOS stent for pancreatic fluid drainage have been consistently shown in several studies. Although it is less common with this novel stent, stent migration still may happen. We present a case of AXIOS stent migration into the esophagus. PMID:28584846

Treatment of Malignant Biliary Obstruction with a PTFE-Covered Self-Expandable Nitinol Stent

PubMed Central

Kwak, Hyo-Sung; Jin, Gong-Yong; Lee, Seung-Ok; Chung, Gyung-Ho

2007-01-01

Objective We wanted to determine the technical and clinical efficacy of using a PTFE-covered self-expandable nitinol stent for the palliative treatment of malignant biliary obstruction. Materials and Methods Thirty-seven patients with common bile duct strictures caused by malignant disease were treated by placing a total of 37 nitinol PTFE stents. These stents were covered with PTFE with the exception of the last 5 mm at each end; the stent had an unconstrained diameter of 10 mm and a total length of 50-80 mm. The patient survival rate and stent patency rate were calculated by performing Kaplan-Meier survival analysis. The bilirubin, serum amylase and lipase levels before and after stent placement were measured and then compared using a Wilcoxon signed-rank test. The average follow-up duration was 27.9 weeks (range: 2-81 weeks). Results Placement was successful in all cases. Seventy-six percent of the patients (28/37) experienced adequate palliative drainage for the remainder of their lives. There were no immediate complications. Three patients demonstrated stent sludge occlusion that required PTBD (percutaneous transhepatic biliary drainage) irrigation. Two patients experienced delayed stent migration with stone formation at 7 and 27 weeks of follow-up, respectively. Stent insertion resulted in acute elevations of the amylase and lipase levels one day after stent insertion in 11 patients in spite of performing endoscopic sphincterotomy (4/6). The bilirubin levels were significantly reduced one week after stent insertion (p < 0.01). The 30-day mortality rate was 8% (3/37), and the survival rates were 49% and 27% at 20 and 50 weeks, respectively. The primary stent patency rates were 85%, and 78% at 20 and 50 weeks, respectively. Conclusion The PTFE-covered self-expandable nitinol stent is safe to use with acceptable complication rates. This study is similar to the previous studies with regard to comparing the patency rates and survival rates. PMID:17923784

Peri-stent aneurysm formation following a stent implant for stenotic intracranial vertebral artery dissection: a technical report of two cases successfully treated with coil embolization.

PubMed

Ishimaru, Hideki; Nakashima, Kazuaki; Takahata, Hideaki; Matsuoka, Yohjiro

2013-02-01

Although stenting for stenotic vertebral artery dissection (VAD) improves compromised blood flow, subsequent peri-stent aneurysm (PSA) formation is not well-known. We report two cases with PSA successfully treated with coil embolization. Three patients with stenotic intracranial VAD underwent endovascular angioplasty at our institution because they had acute infarction in posterior circulation territory and clinical evidence of hemodynamic insufficiency. In two of three patients balloon angioplasty at first session failed to relieve the stenosis, and a coronary stent was implanted. Angiography immediately after stenting showed no abnormality in case 1 and minimal slit-like projection at proximal portion of the stent in case 2. Angiography obtained 16 months after the stenting revealed PSA in case 1. In case 2, angiography performed 3 months later showed that the projection at proximal portion enlarged and formed an aneurysm outside the stent. Because follow-up angiographies showed growth of the aneurysm in both cases, endovascular aneurysmal embolization was performed. We advanced a microcatheter into the aneurysm through the strut of existing stent and delivered detachable coils into the aneurysm lumen successfully in both cases. The post-procedural course was uneventful, and complete obliteration of aneurysm was confirmed on angiography in both cases. Stenting for stenotic intracranial VAD may result in delayed PSA; therefore, follow-up angiographies would be necessary after stenting for stenotic intracranial arterial dissection. Coil embolization through the stent strut would be a solution for enlarging PSA.

Successful removal of self-expanding metallic stent after deployment for tubercular bronchostenosis.

PubMed

Isaac, Barney Thomas Jesudason; Datey, Ashima; Christopher, Devasahayam Jesudas

2016-01-01

The use of metallic stents is traditionally not recommended for benign tracheobronchial conditions. With advances in the field of interventional bronchoscopy, metal tracheobronchial stents have occasionally been used to treat benign disease. However, the removal of these stents from the airway is technically difficult. We are reporting the case of a young female subject who received a self-expanding metallic stent for alleviation of post-tubercular bronchostenosis, which was successfully removed after two months without complications. Metal stents can be used in benign tracheobronchial conditions but require meticulous follow-up to monitor complications. Experienced operators can remove them without major complications and this may be life-saving in emergencies. We are reporting this case for the rarity of such procedures in India. Copyright © 2015 Tuberculosis Association of India. Published by Elsevier B.V. All rights reserved.

Fabrication and Optimal Design of Biodegradable Polymeric Stents for Aneurysms Treatments

PubMed Central

Han, Xue; Wu, Xia; Kelly, Michael; Chen, Xiongbiao

2017-01-01

An aneurysm is a balloon-like bulge in the wall of blood vessels, occurring in major arteries of the heart and brain. Biodegradable polymeric stent-assisted coiling is expected to be the ideal treatment of wide-neck complex aneurysms. This paper presents the development of methods to fabricate and optimally design biodegradable polymeric stents for aneurysms treatment. Firstly, a dispensing-based rapid prototyping (DBRP) system was developed to fabricate coil and zigzag structures of biodegradable polymeric stents. Then, compression testing was carried out to characterize the radial deformation of the stents fabricated with the coil or zigzag structure. The results illustrated the stent with a zigzag structure has a stronger radial stiffness than the one with a coil structure. On this basis, the stent with a zigzag structure was chosen for the development of a finite element model for simulating the real compression tests. The result showed the finite element model of biodegradable polymeric stents is acceptable within a range of radial deformation around 20%. Furthermore, the optimization of the zigzag structure was performed with ANSYS DesignXplorer, and the results indicated that the total deformation could be decreased by 35.7% by optimizing the structure parameters, which would represent a significant advance of the radial stiffness of biodegradable polymeric stents. PMID:28264515

Endoscopic Stent Placement in the Palliation of Malignant Biliary Obstruction

PubMed Central

2011-01-01

Biliary drainage with biliary stent placement is the treatment of choice for palliation in patients with malignant biliary obstruction caused by unresectable neoplasms. In such patients, the endoscopic approach can be initially used with percutaneous radiological intervention. In patients with unresectable malignant distal bile duct obstructions, endoscopic biliary drainage with biliary stent placement has now become the main and least invasive palliative modality, which has been proven to be more effective in >80% of cases with lower morbidity than surgery, and perhaps may provide a survival benefit. In patients with unresectable malignant hilar obstruction, the endoscopic approach for biliary drainage with biliary stent placement has also been considered as the treatment of choice. There is still a lack of clear consensus on the use of covered versus uncovered metal stents in malignant distal bile duct obstructions and plastic versus metal stents and unilateral versus bilateral drainage in malignant hilar obstructions. PMID:22741117

Fully covered stents versus partially covered stents for palliative treatment of esophageal cancer: Is there a difference?

PubMed

Alonso Lárraga, J O; Flores Carmona, D Y; Hernández Guerrero, A; Ramírez Solís, M E; de la Mora Levy, J G; Sánchez Del Monte, J C

2018-02-26

Malignant dysphagia is difficulty swallowing resulting from esophageal obstruction due to cancer. The goal of palliative treatment is to reduce the dysphagia and improve oral dietary intake. Self-expandable metallic stents are the current treatment of choice, given that they enable the immediate restoration of oral intake. The aim of the present study was to describe the results of using totally covered and partially covered esophageal stents for palliating esophageal cancer. A retrospective study was conducted on patients with inoperable esophageal cancer treated with self-expandable metallic stents. The 2 groups formed were: group A, which consisted of patients with a fully covered self-expandable stent (SX-ELLA ® ), and group B, which was made up of patients with a partially covered self-expandable stent (Ultraflex ® ). Of the 69-patient total, 50 were included in the study. Group A had 19 men and 2 women and their mean age was 63.6 years (range 41-84). Technical success was achieved in 100% (n=21) of the cases and clinical success in 90.4% (n=19). Group B had 24 men and 5 women and their mean age was 67.5 years (range 43-92). Technical success was achieved in 100% (n=29) of the cases and clinical success in 89.6% (n=26). Complications were similar in both groups (33.3 vs. 51.7%). There was no difference between the 2 types of stent for the palliative treatment of esophageal cancer with respect to technical success, clinical success, or complications. Copyright © 2018 Asociación Mexicana de Gastroenterología. Publicado por Masson Doyma México S.A. All rights reserved.

Study of the Behavior of a Bell-Shaped Colonic Self-Expandable NiTi Stent under Peristaltic Movements

PubMed Central

Puértolas, José A.; López, Enrique

2013-01-01

Managing bowel obstruction produced by colon cancer requires an emergency intervention to patients usually in poor conditions, and it requires creating an intestinal stoma in most cases. Regardless of that the tumor may be resectable, a two-stage surgery is mandatory. To avoid these disadvantages, endoscopic placement of self-expanding stents has been introduced more than 10 years ago, as an alternative to relieve colonic obstruction. It can be used as a bridge to elective single-stage surgery avoiding a stoma or as a definitive palliative solution in patients with irresectable tumor or poor estimated survival. Stents must be capable of exerting an adequate radial pressure on the stenosed wall, keeping in mind that stent must not move or be crushed, guaranteeing an adequate lumen when affected by peristaltic waves. A finite element simulation of bell-shaped nitinol stent functionality has been done. Catheter introduction, releasing at position, and the effect of peristaltic wave were simulated. To check the reliability of the simulation, a clinical experimentation with porcine specimens was carried out. The stent presented a good deployment and flexibility. Stent behavior was excellent, expanding from the very narrow lumen corresponding to the maximum peristaltic pressure to the complete recovery of operative lumen when the pressure disappears. PMID:23841067

The difficult ureter: what is the incidence of pre-stenting?

PubMed

Cetti, R J; Biers, S; Keoghane, S R

2011-01-01

Difficulty may be encountered with retrograde access for rigid and flexible ureterorenoscopy (URS) due to anatomic abnormalities, a narrow ureteric lumen, tortuous ureteric path or previous instrumentation. Ureteric dilatation using a balloon or tapered dilator can occasionally fail and will usually lead to the placement of a ureteric stent. We present our experience and incidence of pre-stenting after failed standard access and dilatation techniques, the aim being to quote a figure for the patient at the time of consent. Data were collected prospectively from a single surgeon at a regional tertiary referral stone unit. The outcomes of those patients pre-stented, for failed access, were recorded. Between December 2007 and December 2008, a total of 119 patients underwent flexible and rigid URS. Mean patient age was 49 years (range, 19-86 years). Of these, 107 cases were undertaken for urolithiasis and 12 cases for diagnosis of upper tract malignancy. 12% (13/107) of cases were for pain and non-diagnostic imaging and 8.4% (9/107) of patients were pre-stented because of failed access, without complication, and subsequently had successful interval treatment. Of the remaining successful cases of confirmed urolithiasis, 33% (28/85) and 67% (56/85) were undertaken for ureteric and renal calculi, respectively. Stone clearance rates were 83% (19/23) and 75% (3/4) for lower pole renal calculi 5-10 mm and > 10 mm in size, respectively. The overall clearance rate for lower pole calculi was 81% (22/27). The ureteric stone clearance rate was 86% (24/28) rising to 92% (24/26) in those solitary stones less than 10 mm in size. The incidence of ureteric pre-stenting in a tertiary referral unit was 8% and should be considered and indeed discussed with patients when obtaining pre-operative consent, especially for purely elective, non-urgent, upper tract cases. The alternative for these difficult, tight ureters is extensive balloon dilatation, with the risk of trauma and the potential for long-term stricture formation.

The relationship between post-stent strut apposition and follow-up strut coverage assessed by a contour plot optical coherence tomography analysis.

PubMed

Kim, Jung-Sun; Ha, Jinyong; Kim, Byeong-Keuk; Shin, Dong-Ho; Ko, Young-Guk; Choi, Donghoon; Jang, Yangsoo; Hong, Myeong-Ki

2014-06-01

This study sought to evaluate the relationship between post-stent strut apposition and follow-up strut coverage using contour plot optical coherence tomographic analysis. Tracking the fate of interested regions of struts at different time points has not been investigated. Post-intervention and 6-month follow-up optical coherence tomographic evaluations were performed in 82 patients treated with biolimus- (n = 37) or sirolimus-eluting stents (n = 45). Post-stent apposition was classified as embedded, apposed, or malapposed. For volumetric stent evaluation, the post-intervention strut-artery distance and the neointimal thickness at follow-up were measured as a function of the circumferential arc length and longitudinal stent length. Computer-generated contour plots of the strut-artery distance and neointimal thickness were compared. The percentages of embedded and malapposed struts after intervention were 1.8% (Interquartile range [IQR]: 0.6% to 6.2%) and 2.3% (IQR: 0.5% to 5.2%), respectively. The percentages of uncovered and malapposed struts at 6 months were 16.0% (IQR: 7.4% to 33.3%) and 0% (IQR: 0% to 0.7%), respectively. The percentage of uncovered struts at 6 months varied significantly with post-stent strut apposition (0% [IQR: 0% to 11.4%] in embedded, 16.3% [IQR: 8.1% to 31.3%] in apposed, and 26.8% [IQR: 0% to 56.3%] in malapposed, p < 0.001 for all pairwise comparisons). In lesions without tissue prolapse, embedded struts were all covered (100% covered struts) compared with those with tissue prolapse (76.8% covered, p < 0.001). The optical coherence tomography-guided optimization of stent strut apposition enhances strut coverage at follow-up. This comprehensive method for evaluating strut apposition may provide more useful information to understanding the serial changes in strut coverage. (Neointimal Coverage After Implantation of Biolimus Eluting Stent With Biodegradable Polymer: Optical Coherence Tomographic Assessment According to the Treatment of Dyslipidemia and Hypertension and the Types of Implanted Drug-Eluting Stents; NCT01502904). Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.