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- Avci, M., et al.
(författare)
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The use of endoanchors in repair EVAR cases to improve proximal endograft fixation
- 2012
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Ingår i: Journal of Cardiovascular Surgery. - 0021-9509. ; 53:4, s. 419-426
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Tidskriftsartikel (refereegranskat)abstract
- Aim. The aim of this paper was to evaluate short-term outcome of the use of endoanchors to secure the primary migrated endograft and additional extender cuffs to the aortic wall in patients with previous failed endovascular aortic aneurysm repair. Methods. Consecutive patients who needed proximal repair of a primary failed endograft due to migration (with or without type IA endoleaks) were treated with endoanchors, with or without additional extender cuffs. Data of this group were prospectively gathered in vascular referral centers that were early adopters of the endoanchor technique. Preprocedural and periprocedural data were prospectively gathered and retrospectively analyzed. Follow-up after endoanchor placement consisted of regular hospital visits, with computed tomography or duplex scanning at 1, 6, and 12 months. Results. From July 2010 to May 2011, 11 patients (8 men), mean age 77 years (range, 59-88 years), were treated with endoanchors for a failed primary endograft (2 Excluder endografts, 1 AneuRx endograft, and 8 Talent endografts) due to distal migration of the main body, with or without type IA endoleak. Revision consisted of using endoanchors to secure the body of the primary endograft to the aortic wall to avoid persistent migration. Most patients had additional proximal extender cuffs with suprarenal fixation, which were secured with endoanchors to the aortic wall and in some patients also to the primary endograft. A median of 6 endoanchors were implanted. All endoanchors were positioned correctly but one. One endoanchor dislodged but was successfully retrieved using an endovascular snare. During a mean follow-up of 10 months (range, 3-18 months) no endoanchor-related complications or renewed migration of the endografts occurred. Two patients underwent repeat intervention due to persistent type IA endoleak during follow-up. Conclusion. The use of endoanchors to secure migrated endografts to the aortic wall is safe and feasible and might help to overcome persistent migration of primary failed endografts. In combination with the use of sole extender cuffs the majority of proximal EVAR failures can be solved.
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| 2. |
- Bachoo, P., et al.
(författare)
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Early outcome of endovascular aneurysm repair in challenging aortic neck morphology based on experience from the GREAT C3 registry
- 2013
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Ingår i: Journal of Cardiovascular Surgery. - 0021-9509 .- 1827-191X. ; 54:5, s. 573-580
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Tidskriftsartikel (refereegranskat)abstract
- Aim. The aim of this paper was to evaluate early outcome of the GORE (R) EXCLUDER (R) AAA Endoprosthesis featuring C3 Delivery System in subjects with aortic neck anatomy outside IFU. Methods. Individual patient data prospectively collected over a 2 year period from the Global Registry for Endovascular Aortic Treatment (GREAT). For each subject a minimum data set was collected containing demographic, pre/intra- and postoperative variables. Main outcome measures were successful exclusion of the AAA and occurrence of any major endoleak at 1 month. In this study, outside IFU was defined as aortic neck length less than 15 mm and/or aortic neck angle greater than 60 degrees. Results. A total of 400 subjects, (86.6% male, mean age 73.9 years). Primary pathology was AAA in 94.2% with 98.2% undergoing EVAR as a primary procedure. Sixty-eight subjects underwent EVAR outside IFU (neck length <15 nun N.=32, neck angle >60 degrees N.=47 and neck length <15 nun and angle >60 degrees N.=11). The graft was successfully deployed within 5 nun of its intended location in 63 (94%) cases utilising a total of 33 repositioning episodes. Eight aortic cuffs were used, 5 to treat a type 1 endoleak. At 30 days we recorded 2 type 2 endoleaks both successfully treated and 1 type 1b also successfully treated. There were 2 deaths, one in each group. Conclusion. GORE (R) EXCLUDER (R) AAA Endoprosthesis featuring C3 Delivery System allows re-positioning to be performed safely in cases outside IFU. Repositioning is an effective operative manoeuvre and facilitates EVAR in challenging anatomy. Longer follow-up is required to evaluate the durability of these results at 30 days.
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| 3. |
- Brunkwall, J., et al.
(författare)
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Endovascular Repair of Acute Uncomplicated Aortic Type B Dissection Promotes Aortic Remodelling: 1 Year Results of the ADSORB Trial
- 2014
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Ingår i: European Journal of Vascular and Endovascular Surgery. - : Elsevier BV. - 1532-2165 .- 1078-5884. ; 48:3, s. 285-291
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Tidskriftsartikel (refereegranskat)abstract
- Objectives: Uncomplicated acute type B aortic dissection (AD) treated conservatively has a 10% 30-day mortality and up to 25% need intervention within 4 years. In complicated AD, stent grafts have been encouraging. The aim of the present prospective randomised trial was to compare best medical treatment (BMT) with BMT and Gore TAG stent graft in patients with uncomplicated AD. The primary endpoint was a combination of incomplete/no false lumen thrombosis, aortic dilatation, or aortic rupture at 1 year. Methods: The AD history had to be less than 14 days, and exclusion criteria were rupture, impending rupture, malperfusion. Of the 61 patients randomised, 80% were DeBakey type IIIB. Results: Thirty-one patients were randomised to the BMT group and 30 to the BMT+TAG group. Mean age was 63 years for both groups. The left subclavian artery was completely covered in 47% and in part in 17% of the cases. During the first 30 days, no deaths occurred in either group, but there were three crossovers from the BMT to the BMT TAG group, all due to progression of disease within 1 week. There were two withdrawals from the BMT+TAG group. At the 1-year follow up there had been another two failures in the BMT group: one malperfusion and one aneurysm formation (p = .056 for all). One death occurred in the BMT TAG group. For the overall endpoint BMT+TAG was significantly different from BMT only (p < .001). Incomplete false lumen thrombosis, was found in 13 (43%) of the TAG+BMT group and 30 (97%) of the BMT group (p < .001). The false lumen reduced in size in the BMT+TAG group (p < .001) whereas in the BMT group it increased. The true lumen increased in the BMT TAG (p < .001) whereas in the BMT group it remained unchanged. The overall transverse diameter was the same at the beginning and after 1 year in the BMT group (42.1 mm), but in the BMT+TAG it decreased (38.8 mm; p = .062). Conclusions: Uncomplicated AD can be safely treated with the Gore TAG device. Remodelling with thrombosis of the false lumen and reduction of its diameter is induced by the stent graft, but long term results are needed. (C) 2014 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.
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| 6. |
- Verhoeven, E. L. G., et al.
(författare)
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Real-world Performance of the New C3 Gore Excluder Stent-Graft : 1-year Results from the European C3 Module of the Global Registry for Endovascular Aortic Treatment (GREAT)
- 2014
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Ingår i: European Journal of Vascular and Endovascular Surgery. - : Elsevier BV. - 1078-5884 .- 1532-2165. ; 48:2, s. 131-137
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Tidskriftsartikel (refereegranskat)abstract
- Objectives: The European C3 module of the Global Registry for Endovascular Aortic Treatment (GREAT) provides "real-world" outcomes for the new C3 Gore Excluder stent-graft, and evaluates the new deployment mechanism. This report presents the 1-year results from 400 patients enrolled in this registry. Methods: Between August 2010 and December 2012, 400 patients (86.8% male, mean age 73.9 +/- 7.8 years) from 13 European sites were enrolled in this registry. Patient demographics, treatment indication, case planning, operative details including repositioning and technical results, and clinical outcome were analyzed. Results: Technical success was achieved in 396/400 (99%) patients. Two patients needed intraoperative open conversion, one for iliac rupture, the second because the stent-graft was pulled down during a cross-over catheterization in an angulated anatomy. Two patients required an unplanned chimney renal stent to treat partial coverage of the left renal artery because of upward displacement of the stent-graft. Graft repositioning occurred in 192/399 (48.1%) patients, most frequently for level readjustment with regard to the renal arteries, and less commonly for contralateral gate reorientation. Final intended position of the stent-graft below the renal arteries was achieved in 96.2% of patients. Thirty-day mortality was two (0.5%) patients. Early reintervention (<= 30 days) was required in two (0.5%) patients. Mean follow-up duration was 15.9 +/- 8.8 months (range 0-37 months). Late reintervention (>30 days) was required in 26 (6.5%) patients. Estimated freedom from reintervention at 1 year was 95.2% (95% CI 92.3-97%), and at 2 years 91.5% (95% CI 86.8-94.5%). Estimated patient survival at 1 year was 96% (95% CI 93.3-97.6%) and at 2 years 90.6% (95% CI 85.6-93.9%). Conclusions: Early real-world experience shows that the new C3 delivery system offers advantages in terms of device repositioning resulting in high deployment accuracy. Longer follow-up is required to confirm that this high deployment accuracy results in improved long-term durability.
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