scholarly journals TCTAP A-054 Morphological Changes of Altura Stent-graft and Clinical Results After Endovascular Aneurysm Repair

2019 ◽  
Vol 73 (15) ◽  
pp. S28
Author(s):  
Artis Knapsis ◽  
Janis Savlovskis ◽  
Dainis Krievins ◽  
Hubert Schelzig ◽  
Alexander Oberhuber
2017 ◽  
Vol 24 (2) ◽  
pp. 191-197 ◽  
Author(s):  
Gianmarco de Donato ◽  
Francesco Setacci ◽  
Luciano Bresadola ◽  
Patrizio Castelli ◽  
Roberto Chiesa ◽  
...  

Purpose: To compare the use of the Ovation stent-graft according to the ≥7-mm neck length specified by the original instructions for use (IFU) vs those treated off-label (OL) for necks <7 mm long. Methods: A multicenter retrospective registry (TriVascular Ovation Italian Study) database of all patients who underwent endovascular aneurysm repair with the Ovation endograft at 13 centers in Italy was interrogated to identify patients with a minimum computed tomography (CT) follow-up of 24 months, retrieving records on 89 patients (mean age 76.4±2.4 years; 84 men) with a mean follow-up of 32 months (range 24–50). Standard CT scans (preoperative, 1-month postoperative, and latest follow-up) were reviewed by an independent core laboratory for morphological changes. For analysis, patients were stratified into 2 groups based on proximal neck length ≥7 mm (IFU group, n=57) or <7 mm (OL group, n=32). Outcome measures included freedom from type Ia endoleak, any device-related reintervention, migration, and neck enlargement (>2 mm). Results: At 3 years, there was no aneurysm-related death, rupture, stent-graft migration, or neck enlargement. There were no differences in terms of freedom from type Ia endoleak (98.2% IFU vs 96.8% OL, p=0.6; hazard ratio [HR] 0.55, 95% CI 0.02 to 9.71 or freedom from any device-related reintervention (92.8% IFU vs 96.4% OL, p=0.4; HR 2.42, 95% CI 0.34 to 12.99). In the sealing zone, the mean change in diameters was −0.05±0.8 mm in the IFU group and −0.1±0.5 mm in the OL group. Conclusion: Use of the Ovation stent-graft in patients with neck length <7 mm achieved midterm outcomes similar to patients with ≥7-mm-long necks. These midterm data show that the use of the Ovation system for the treatment of infrarenal abdominal aortic aneurysm is not restricted by the conventional measurement of aortic neck length, affirming the recent Food and Drug Administration–approved changes to the IFU.


Author(s):  
Zia Ur Rehman

Endoleaks are the most common complications following endovascular aneurysm repair. Depending upon their origin, there are five types of endoleaks, types I-V, which can also be classified as direct and indirect endoleaks. Direct endoleaks type 1 and III have higher risk of aneurysm rupture due to rapid sac expansion, and require immediate correction.  Indirect endoleaks types II, IV and V have a relatively benign course compared to direct endoleaks. Most of them resolve with time and very few of them need interventions upon sac enlargement. Type V endotension is a special situation where there is sac enlargement despite no demonstrable endoleak. Proper planning and appropriate selection of stent-graft can prevent most of these endoleaks. With improvement in stent-graft technology, the incidence of endoleaks has been reduced. The current narrative review was planned to describe the pathophysiology, risk factors and treatment options for each type of endoleak. Continuous...


2018 ◽  
Vol 26 (1) ◽  
pp. 72-75
Author(s):  
Fabien Lareyre ◽  
Claude Mialhe ◽  
Carine Dommerc ◽  
Juliette Raffort

Purpose: To report the use of the Nellix endovascular aneurysm sealing (EVAS) system in the management of proximal stent-graft collapse associated with thrombosis following endovascular aneurysm repair (EVAR). Case Report: A 76-year-old man was admitted for proximal collapse of an aortic extension following bifurcated AFX stent-graft implantation associated with chimney grafts in both renal arteries and the superior mesenteric artery 1 month prior. Imaging identified thrombosis of the aortic stent-graft and the iliac limbs. A Nellix EVAS was placed into the AFX stent-graft to recanalize the aneurysm lumen and address the aortic thrombosis. There was no endoleak, and the renovisceral chimney stent-grafts remained patent over a follow-up of 25 months. Conclusion: While further studies are required to generalize its use, EVAS appears to be feasible in the management of aortic stent-graft collapse.


2017 ◽  
Vol 39 ◽  
pp. 293.e1-293.e5 ◽  
Author(s):  
Athanasios Katsargyris ◽  
Domenico Spinelli ◽  
Kyriakos Oikonomou ◽  
Hozan Mufty ◽  
Eric LG. Verhoeven

2013 ◽  
Vol 54 (1) ◽  
pp. 54-58 ◽  
Author(s):  
Thomas Nyheim ◽  
Lars Erik Staxrud ◽  
L Rosen ◽  
Carl Erik Slagsvold ◽  
Gunnar Sandbæk ◽  
...  

Background Simplifying a postoperative surveillance protocol for endovascular aneurysm repair (EVAR) requires quality control comparing computerized tomography (CT) and ultrasound (US) results of abdominal aortic aneurysm (AAA) diameter measurements and endoleaks. Purpose To test if US is comparable to CT, then assess a simplified follow-up with our conventional surveillance to assess patient safety. Material and Methods During 2001-2006, data on 56 patients treated with Talent stent graft were prospectively registered. Median follow-up was 41.5 months (range, 2-94 months), with CT, US, and plain film abdomen X-rays (PFA) at 1, 6, and 12 months, then yearly. Bland-Altman plot was used to assess the agreement between CT and US measuring the AAA diameters and mixed model by the time effect to assess the difference in diameter over time. Sensitivity and specificity for detection of endoleaks by US, with CT as ‘gold standard’ were calculated. A simplified surveillance protocol with US/PFA at 6 and 8 weeks, CT/US/PFA at 1 year, and yearly US/PFA thereafter, was evaluated. CT was carried out when poor visibility, endoleak detected, AAA diameter increase (≥5 mm) on US or migration (≥10 mm) on PFA. This regime was compared with our conventional follow-up protocol. Results Diameter measurements on US appear comparable to CT with 91% specificity and 85% sensitivity for endoleaks detected by US. Using the simplified surveillance protocol no endoleaks, migrations, or endotension requiring treatment were overlooked. The simplified protocol generated 53 selective CT scans, avoiding approximately 144 CT scans. If further simplified by omitting the 1-year CT scan, one type II endoleak would be missed with a 1-year delay, eliminating a further 45 CT scans. Conclusion US appears comparable to CT in the follow-up of Talent stent grafts in our institution. The proposed simplified surveillance protocol seems safe and can lead to a significant reduction in the number of CT scans.


2018 ◽  
Vol 25 (1) ◽  
pp. 21-27 ◽  
Author(s):  
David L. Dawson ◽  
Giuliano de Almeida Sandri ◽  
Emanuel Tenorio ◽  
Gustavo S. Oderich

Purpose: To describe a modified up-and-over access technique for treatment of iliac artery aneurysms in patients with prior bifurcated stent-grafts for endovascular aneurysm repair (EVAR). Technique: This technique uses a coaxial 12-F flexible sheath that is docked with a through-and-through wire into a 7-F sheath advanced from the contralateral femoral approach. This maneuver allows both sheaths to be moved as a unit while maintaining position of the apex of the system as it loops over the flow divider, avoiding damage to or displacing the extant endograft. Once the 12-F sheath is positioned in the iliac limb of the aortic stent-graft and secured in place with the through-and-through wire, the repair is extended into the internal iliac artery using a bridging stent-graft or covered stent introduced via a coaxial sheath. Conclusion: The up-and-over technique with a flexible 12-F sheath mated with a 7-F sheath from the opposite side allows bilateral femoral access to be used for iliac branch device placement after prior aortic endograft procedures that create a higher, acutely angled bifurcation. Use of a through-and-through wire and a coaxial sheath for stent delivery creates a very stable platform for intervention.


2018 ◽  
Vol 25 (3) ◽  
pp. 379-386 ◽  
Author(s):  
Dainis Krievins ◽  
Albrecht Krämer ◽  
Janis Savlovskis ◽  
Georgij Oszkinis ◽  
E. Sebastian Debus ◽  
...  

Purpose: To report the initial clinical results of endovascular aneurysm repair (EVAR) using the low-profile (14-F) Altura Endograft System, which features a double “D-shaped” stent design with suprarenal fixation and modular iliac components that are deployed from distal to proximal. Methods: From 2011 to 2015, 90 patients (mean age 72.8±8.3 years; 79 men) with abdominal aortic aneurysm (AAA; mean diameter 53.8±5.7 mm) were treated at 10 clinical sites in 2 prospective, controlled clinical studies using the Altura endograft. Outcomes evaluated included mortality, major adverse events (MAEs: all-cause death, stroke, paraplegia, myocardial infarction, respiratory failure, bowel ischemia, and blood loss ≥1000 mL), and clinical success (freedom from procedure-related death, type I/III endoleak, migration, thrombosis, and reintervention). Results: Endografts were successfully implanted in 89 (99%) patients; the single failure was due to delivery system malfunction before insertion in the early-generation device. One (1%) patient died and 4 patients underwent reinterventions (1 type I endoleak, 2 iliac limb stenoses, and 1 endograft occlusion) within the first 30 days. During a median follow-up of 12.5 months (range 11.5–50.9), there were no aneurysm ruptures, surgical conversions, or AAA-related deaths. The cumulative MAE rates were 3% (3/89) at 6 months and 7% (6/89) at 1 year. Two patients underwent coil embolization of type II endoleaks at 6.5 months and 2.2 years, respectively. Clinical success was 94% (84/89) at 30 days, 98% (85/87) at 6 months, and 99% (82/83) at 1 year. Conclusion: Early results suggest that properly selected AAA patients can be safely treated using the Altura Endograft System with favorable midterm outcome. Thus, further clinical investigation is warranted to evaluate the role of this device in the treatment of AAA.


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