| 1. |
- Ederle, Joerg, et al.
(author)
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Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial
- 2010
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In: The Lancet. - 1474-547X. ; 375:9719, s. 985-997
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Journal article (peer-reviewed)abstract
- Background Stents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy. Methods The International Carotid Stenting Study (ICSS) is a multicentre, international, randomised controlled trial with blinded adjudication of outcomes. Patients with recently symptomatic carotid artery stenosis were randomly assigned in a 1:1 ratio to receive carotid artery stenting or carotid endarterectomy. Randomisation was by telephone call or fax to a central computerised service and was stratified by centre with minimisation for sex, age, contralateral occlusion, and side of the randomised artery. Patients and investigators were not masked to treatment assignment. Patients were followed up by independent clinicians not directly involved in delivering the randomised treatment. The primary outcome measure of the trial is the 3-year rate of fatal or disabling stroke in any territory, which has not been analysed yet. The main outcome measure for the interim safety analysis was the 120-day rate of stroke, death, or procedural myocardial infarction. Analysis was by intention to treat (ITT). This study is registered, number ISRCTN25337470. Findings The trial enrolled 1713 patients (stenting group, n=855; endarterectomy group, n=858). Two patients in the stenting group and one in the endarterectomy group withdrew immediately after randomisation, and were not included in the ITT analysis. Between randomisation and 120 days, there were 34 (Kaplan-Meier estimate 4.0%) events of disabling stroke or death in the stenting group compared with 27 (3.2%) events in the endarterectomy group (hazard ratio [HR] 1.28, 95% CI 0.77-2.11). The incidence of stroke, death, or procedural myocardial infarction was 8.5% in the stenting group compared with 5.2% in the endarterectomy group (72 vs 44 events; HR 1.69, 1.16-2.45, p=0.006), Risks of any stroke (65 vs 35 events; HR 1.92, 1.27-2.89) and all-cause death (19 vs seven events; HR 2.76, 1.16-6.56) were higher in the stenting group than in the endarterectomy group. Three procedural myocardial infarctions were recorded in the stenting group, all of which were fatal, compared with four, all non-fatal, in the endarterectomy group. There was one event of cranial nerve palsy in the stenting group compared with 45 in the endarterectomy group. There were also fewer haematomas of any severity in the stenting group than in the endarterectomy group (31 vs 50 events; p=0.0197). Interpretation Completion of long-term follow-up is needed to establish the efficacy of carotid artery stenting compared with endarterectomy. In the meantime, carotid endarterectomy should remain the treatment of choice for patients suitable for surgery.
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| 2. |
- Tranberg, K. G., et al.
(author)
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The YAG laser and Wallstent endoprosthesis for palliation of cancer in the esophagus or gastric cardia
- 1995
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In: Hepato-Gastroenterology. - 0172-6390. ; 42:2, s. 139-144
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Journal article (peer-reviewed)abstract
- The need for frequent retreatment is a disadvantage of using endoscopic laser therapy (ELT) alone for palliative treatment of esophageal carcinoma. In this prospective study, therefore, we investigated the potential and feasibility of combining ELT with a self-expanding metallic stent (Wallstent). Twelve patients received ELT followed by stent placement (stent group) and were compared with 39 patients receiving ELT alone (ELT group). Swallowing ability was similar in the two groups. About one-third of the patients who had a short life expectancy, did not appear to benefit from stenting, whereas the interval between retreatments was prolonged by a factor of 2-4 in the remaining patients. Median survivals were 5.5 (range 1.0-23.5) months in patients with stents, and 4.5 (range 1.2-24.6) months in patients without stents. There were few complications related to stenting. In one patient, technical problems caused stent dislodgement into the stomach. Another stent patient died of hemorrhage from an untreated tumor in the stomach, but it was considered unlikely that the bleeding was caused by the stent. In conclusion, this preliminary trial suggests that a Wallstent endoprosthesis, used in combination with laser treatment, may become a valuable tool for prolonging the dysphagia-free interval in selected patients.
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| 3. |
- Dias, Nuno, et al.
(author)
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Complicated Acute Type B Dissections-An 8-years Experience of Endovascular Stent-graft Repair in a Single Centre.
- 2006
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In: European Journal of Vascular and Endovascular Surgery. - : Elsevier BV. - 1532-2165 .- 1078-5884. ; 31:5, s. 481-486
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Journal article (peer-reviewed)abstract
- Objective. To analyze the experience of a single centre using stent-grafts for treatment of complicated acute aortic type B-dissections (EVR-ABD). Design. Retrospective analysis of prospectively collected data from patients undergoing EVR-ABD between January 1997 and December 2004. Methods. EVR-ABD was performed in 31 patients (20 males, median age 74. years (IQR: 64-79)). Indications for treatment were aortic rupture (22 patients), intractable pain and hypertension (six patients), acute bowel ischemia (two patients) and transient paraplegia, lower limb and renal ischemia in one patient. Initially home-made devices (five patients) and subsequently commercially available thoracic stent-grafts were used. Results. Five patients (16%) died within 30 days of EVR-ABD. Postoperative complications occurred in 15 (48%) patients, including one paraplegia converted to paraparesis after cerebrospinal fluid drainage, five strokes, three lower limb ischemia, three myocardial infarction, two pneumonia and one colitis). Re-interventions were required in nine patients (29%). Six more deaths occurred during a median follow-up of 22 (IQR: 16-34) months, two related to the stent-graft and four due to cardiac disease. Conclusions. Stent-graft repair of complicated acute type B dissections seems to provide acceptable results and, therefore, it may be considered a valuable alternative to open surgery.
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| 4. |
- Greenberg, R, et al.
(author)
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Endovascular repair of descending thoracic aortic aneurysms: an early experience with intermediate-term follow-up
- 2000
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In: Journal of Vascular Surgery. - 1097-6809. ; 31:1 Pt 1, s. 147-156
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Journal article (peer-reviewed)abstract
- PURPOSE: The purpose of this study was to report an initial experience with the endovascular repair of descending thoracic aortic aneurysm. Complications and intermediate-term morphologic changes were identified with the intent of altering patient selection and device design. METHODS: Endografts were placed into 25 patients at high-risk for conventional surgical repair over a 3(1/2)-year period. Devices were customized on the basis of preoperative imaging information. Follow-up computed tomography scans were obtained at 1, 3, 6, and 12 months and yearly thereafter. Additional interventions occurred in the setting of endoleaks, migration, and aneurysm growth. RESULTS: The overall 30-day mortality rate was 20% (12.5% for elective cases; 33% for emergent cases). There were 3 conversions to open repair. Neurologic deficits developed in 3 patients; 1 insult resulted in permanent paraplegia. Neurologic deficits were associated with longer endografts (P =.019). Three endoleaks required treatment, and 1 fatal rupture of the thoracic aneurysm treated occurred 6 months after the initial repair. Migrations were detected in 4 patients. The maximal aneurysm size decreased yearly by 9.15% (P =.01) or by 13.5% (P =.0005) if patients with endoleaks (n = 3 patients) were excluded. Both the proximal and distal neck dilated slightly over the course of follow-up (P =.019 and P =.001, respectively). The length of the proximal neck was a significant predictor of the risk for endoleakage (P =.02). CONCLUSION: The treatment of descending thoracic aortic aneurysms with an endovascular approach is feasible and may, in some patients, offer the best means of therapy. Early complications were primarily related to device design and patient selection. All aneurysms without endoleaks decreased in size after treatment. Late complications were associated with changing aneurysm morphologic features and device migration. The morphologic changes remain somewhat unpredictable; however, alterations in device design may result in improved fixation and more durable aneurysm exclusion.
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| 5. |
- Haulon, Stéphan, et al.
(author)
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Global experience with an inner branched arch endograft.
- 2014
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In: Journal of Thoracic and Cardiovascular Surgery. - : Elsevier BV. - 1097-685X .- 0022-5223. ; 148:4, s. 1709-1716
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Journal article (peer-reviewed)abstract
- Branched endografts are a new option to treat arch aneurysm in high-risk patients.
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| 6. |
- Hinchliffe, R J, et al.
(author)
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Observations on the Failure of Stent-Grafts in the Aortic Arch.
- 2007
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In: European Journal of Vascular and Endovascular Surgery. - : Elsevier BV. - 1532-2165 .- 1078-5884. ; 34:4, s. 6-451
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Journal article (peer-reviewed)abstract
- Abstract INTRODUCTION: The results of endovascular stent-grafts in the abdominal aorta and descending thoracic aorta have been encouraging. Expanding the use of thoracic stent-grafts in to the aortic arch has been associated with increasing numbers of complications. Recently isolated cases of stent-graft collapse have been reported. METHODS: This was a multi-centre European case series. Data was collected retrospectively on seven patients from five experienced endovascular centres with thoracic stent-graft collapse. RESULTS: Of the seven patients four were treated for traumatic aortic rupture. Six were male, median age 33 (range 17-54) years. During the ensuing 2 months all patients suffered stent-graft collapse. This was symptomatic in 3 patients and the rest were identified on CT. Endovascular management was possible in 6/7 patients using either a balloon expandable stent (n=6) or further stent-graft (n=1). Two patients had persistent type I endoleak despite treatment. Two of the 7 patients died, both of which presented with symptomatic thoracic stent-graft occlusion. Both deaths were a direct result of stent-graft collapse. CONCLUSIONS: Thoracic stent-graft collapse may be asymptomatic underscoring the importance of stent-graft surveillance. Endovascular management of collapse is possible in most cases using a large balloon expandable stent. Symptomatic collapse is associated with high morbidity and mortality.
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| 7. |
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| 8. |
- Lindh, Mats, et al.
(author)
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Endovascular stent-anchored aortic grafts: a comparison between self-expanding and balloon-expandable stents in minipigs
- 1996
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In: Journal of Endovascular Surgery. - 1074-6218. ; 3:3, s. 284-289
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Journal article (peer-reviewed)abstract
- PURPOSE: To study endovascular graft attachment with self-expanding Gianturco Z-stents and balloon-expanded Palmaz stents and the effect of these devices on the renal ostia. METHODS: Ten stent-grafts were constructed, 5 with Gianturco Z-stents and 5 with Palmaz stents. The endografts were implanted under fluoroscopic guidance into the abdominal aorta of 10 pigs so that the uncovered portion of the proximal stent extended over the renal artery orifices. Distal aortic blood pressure and flow were measured before and after graft placement and 1 hour postprocedure. The aorta was then exposed surgically, and the central portion of the stent-graft was inspected through an aortotomy to assess perigraft leakage. RESULTS: Stent-graft implantation was accurate and hemostatic in all cases, despite longitudinal folding of the graft due to oversizing. However, transverse folds produced pressure gradients (> 15 mmHg) between the ends of the graft in two cases. In another case, a pressure gradient resulted from partial thrombosis of the graft. In two cases, renal artery occlusion and thrombosis occurred due to coverage by the graft material. In two other animals, one of the renal arteries was entirely uncovered by a stent. The remaining 16 renal arteries were covered by the proximal stent but not the graft, as intended. One (6.25%) of these arteries thrombosed, but the remainder were grossly patent when the animals were sacrificed at 1 hour. CONCLUSIONS: Both Palmaz and Gianturco Z-stents produced hemostatic endovascular graft attachment, even in the presence of moderate graft oversizing. The risk of acute renal artery occlusion from juxtarenal stenting does not appear to be prohibitive, but longer term observations are needed.
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| 9. |
- Vogt, K C, et al.
(author)
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The use of intravascular ultrasound as control procedure for the deployment of endovascular stented grafts
- 1997
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In: European Journal of Vascular and Endovascular Surgery. - 1532-2165. ; 13:6, s. 592-596
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Journal article (peer-reviewed)abstract
- OBJECTIVE: To assess whether intravascular ultrasound (IVUS), used systematically in a series of patients with abdominal aortic aneurysms (AAA), is a feasible control procedure to ensure correct transfemoral placement of endovascular stent grafts (TPEG). DESIGN: Descriptive study. MATERIALS AND METHODS: Fourteen patients with infrarenal aortic aneurysms were treated by the placement of one tube graft, 10 aorto-uni-iliac and three aorto-bi-iliac grafts. Arteriography and IVUS were performed before, during and after deployment of the graft to ensure correct placement in relation to side branches, and proper adaptation of the stents to the aortic wall. Postoperative CT-scan and arteriography served as control procedures. RESULTS: IVUS identified both renal arteries before graft deployment in eight of 13 (62%) patients. In the remaining patients only one renal artery was visualised due to interference from guidewires or the introducer system. Imaging during stent deployment was abandoned after IVUS catheter damage in two of three cases. Postprocedural IVUS was able to evaluate the expansion of the stents and the adaptation to the aortic wall in all instances. In four (29%) cases a leak was identified. Additional intervention included deployment of a further stent (n = 2) or redilation (n = 2). Covering of the renal arteries could only be indirectly determined by IVUS. CONCLUSION: IVUS can provide important decisive information before and after stented graft deployment, with the limitations that guidewires, introducer system and stents may cause interference. Contemporary IVUS designs are unsuitable for monitoring stent deployment.
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| 10. |
- Yoon, H K, et al.
(author)
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Stent-graft repair of a splenic artery aneurysm
- 2001
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In: Cardiovascular and Interventional Radiology. - 1432-086X. ; 24:3, s. 200-203
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Journal article (peer-reviewed)abstract
- We present a case of splenic artery aneurysm (SAA) treated with stent-grafts. This new method offers the benefit of preserving the blood flow through the splenic artery. This in turn allows for subsequent sequential embolization of the spleen when indicated, as in our patient with hypersplenism. This is the first reported case of stent-graft repair of SAA.
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