The Nellix™ EndoVascular sealing system in patients with abdominal aortic aneurysms in conjunction with iliac artery occlusive disease

Vascular ◽  
2016 ◽  
Vol 25 (2) ◽  
pp. 190-195 ◽  
Author(s):  
Steven MM van Sterkenburg ◽  
Leo H van den Ham ◽  
Luuk Smeets ◽  
Jan-Willem Lardenoije ◽  
Michel MPJ Reijnen
Keyword(s):  
Abdominal Aortic Aneurysm ◽  
Aortic Aneurysm ◽  
Iliac Artery ◽  
Occlusive Disease ◽  
Aortic Aneurysms ◽  
Covered Stents ◽  
Single Center ◽  
Technical Success ◽  
Abdominal Aortic

Introduction Concomitant abdominal aortic aneurysm formation and aortoiliac occlusive disease is a challenging combination, often requiring open reconstructive surgery. In this study, we have assessed a single center experience of the Nellix EndoVascular Aneurysm Sealing System in the treatment of an abdominal aortic aneurysm in conjunction with iliac artery occlusive disease. Methods Retrospectively case files of patients treated with Nellix EndoVascular Aneurysm Sealing System in a single center were reviewed. The primary endpoints of the study were the technical success of Nellix EndoVascular Aneurysm Sealing System in patients with coincidental iliac artery occlusive disease and the successful exclusion of the aneurysm during follow-up. Results Of the 96 patients that were treated with Nellix EndoVascular Aneurysm Sealing System, five were identified that had an abdominal aortic aneurysm in conjunction with iliac artery occlusive disease. Treated patients had either unilateral (n = 4) or bilateral (n = 1) common iliac artery occlusive disease varying from 70% stenosis to complete occlusions. The lesion length varied from 5 to 50 mm and in two cases it involved an occluded bare metal stent. The indication for surgery was the abdominal aortic aneurysm in all patients, including three also suffering from claudication. In all patients the iliac artery occlusive disease was pretreated with balloon-expandable covered stents. Technical success was achieved in all five patients. After a median follow-up of nine months all stents were patent with no signs of endoleak and stable aneurysm diameters. All patients were free of intermittent claudication or ischemic wounds. Conclusion Nellix EndoVascular Aneurysm Sealing System seems feasible and safe in patients with a combination of abdominal aortic aneurysm and iliac artery occlusive disease.

Secondary Relining With Focal Flaring of Novel-Generation Balloon-Expandable Covered Stents for Endovascular Treatment of Significant Diameter Mismatch in the Aorto-Iliac Territory

Vascular ◽  
2020 ◽  
pp. 170853812094505
Author(s):  
Mario D’Oria ◽  
Filippo Griselli ◽  
Davide Mastrorilli ◽  
Filippo Gorgatti ◽  
Silvia Bassini ◽  
...  
Keyword(s):  
Abdominal Aortic Aneurysm ◽  
Aortic Aneurysm ◽  
Endovascular Treatment ◽  
Stent Graft ◽  
Iliac Artery ◽  
Common Iliac Artery ◽  
Covered Stents ◽  
Abdominal Aortic ◽  
The Right

Objectives The aim of this study was to report on the safety and feasibility of secondary relining with focal flaring of novel-generation balloon-expandable covered stents for endovascular treatment of significant diameter mismatch in the aorto-iliac territory. Significant diameter mismatch was defined as >20% difference in the nominal diameter between the intended proximal and distal landing zones. Methods Patient A was an 84-year-old man with prior abdominal aortic aneurysm open repair with a straight 20 mm Dacron tube. He presented with a right common iliac artery aneurysm (Ø88 mm) with contained rupture. The Gore Viabahn endoprosthesis (9 mm × 5 cm) was inserted proximally about 15 mm above the occluded ostium of the internal iliac artery. Subsequently, the BeGraft Aortic® (16 mm × 48 mm) was inserted proximally up to the common iliac artery origin; its proximal portion was flared to 22 mm. Patient B was a 77-year-old man with prior endovascular abdominal aortic aneurysm repair with a Medtronic Endurant stent-graft. He presented with occlusion of the right limb of the aortic endoprosthesis and thrombosis that extended down to the level of the superficial femoral artery. After mechanical thrombectomy, two Gore Viabahn endoprosthesis (first one, 8 mm × 10 cm; second one, 10 mm × 15 cm) were inserted into the right iliac limb. Subsequently, the BeGraft Aortic® (12mm × 39mm) was inserted proximally up to the gate of the aortic stent-graft; its proximal portion was flared to 16 mm. Results Technical success and clinical success were achieved in both patients. Imaging follow-up (6 months for Patient A, 12 months for Patient B) showed correct placement of all stent-grafts without any graft-related adverse event. The patients remained free from new reinterventions or recurrent symptoms. Patient A died 8 months after the index procedure from acute respiratory failure after community acquired pneumonia. Conclusion Secondary relining with focal flaring of novel-generation balloon-expandable covered stents for endovascular treatment of significant diameter mismatch in the aorto-iliac territory is safe and feasible. Although mid-term results seem to be effective, longer follow-up is warranted to establish durability of the technique.

scholarly journals Three-Year Results of the Nellix Endovascular Aneurysm Sealing System for Treatment of Abdominal Aortic Aneurysms in Frail Patients with Poor Anatomical Features

2020 ◽  
pp. 145749692091726
Author(s):  
A. Sonetto ◽  
S. Laukontaus ◽  
L. Vikatmaa ◽  
P. Aho ◽  
M. Venermo
Keyword(s):  
Abdominal Aortic Aneurysm ◽  
Aortic Aneurysm ◽  
Open Surgery ◽  
Abdominal Aortic Aneurysms ◽  
Aortic Aneurysms ◽  
Technical Success ◽  
Abdominal Aortic ◽  
Instructions For Use ◽  
Related Mortality

Introduction: Endovascular aneurysm sealing represents an alternative to advanced technology devices for compromised patients with abdominal aortic aneurysms. We report our results of 15 fragile patients with very low-quality infrarenal necks treated with endovascular aneurysm sealing. Material and methods: All patients treated with Nellix device in our hospital between June 2015 and October 2016 were retrospectively reviewed. The primary endpoints are the following: overall survival and freedom from reintervention rates. The secondary endpoints are the following: technical success; 30-day mortality; abdominal aortic aneurysm–related mortality; and freedom from endoleak rate, complications, and surgical conversion rate. Results: Nellix was used in 15 patients, median age 75.5 years, of which 67% were unfit for open surgery. Mean aneurysm diameter was 60 mm. One-third (5/15) of the patients were inside the Nellix instructions for use. Technical success rate was 93.3%. No perioperative complications existed, and 30-day mortality was 0%. Median follow-up was 35 (interquartile range: 11–37) months. Survival rates at 1 and 3 years were 80% and 59.3%. Abdominal aortic aneurysm–related mortality occurred in 3 of 15 cases. Freedom from rupture rates at 1 and 3 years were 92.9% and 66%. Freedom from endoleak rates at 1 and 3 years were 92.9% and 74.5%. Freedom from reintervention rates at 1 and 3 years were 86.7% and 70.6%, with a dramatic drop to 37.1% at 4 years of follow-up. Three open surgery conversions were needed. There were no statistically significant differences in results between patients treated inside and outside instructions for use. Conclusion: The endovascular aneurysm sealing has shown encouraging short-term results, but its safety and effectiveness during time is questionable, because this system still carries high rates of reintervention, conversions for type IA endoleaks, and secondary aneurysm ruptures.

scholarly journals Endovascular repair of aortic aneurysm: Preliminary results

2009 ◽  
Vol 137 (1-2) ◽  
pp. 10-17 ◽  
Author(s):  
Lazar Davidovic ◽  
Momcilo Colic ◽  
Igor Koncar ◽  
Dejan Markovic ◽  
Dusan Kostic ◽  
...  
Keyword(s):  
Abdominal Aortic Aneurysm ◽  
Aortic Aneurysm ◽  
Stent Graft ◽  
Endovascular Aneurysm Repair ◽  
Aortic Aneurysms ◽  
Endovascular Stent ◽  
Stent Grafts ◽  
Graft Thrombosis ◽  
Abdominal Aortic

Introduction. Endovascular aneurysm repair (EVAR) has been introduced into clinical practice at the beginning of the 90's of the last century. Because of economic, political and social problems during the last 25 years, the introduction of this procedure in Serbia was not possible. Objective. The aim of this study was to present preliminary experiences and results of the Clinic for Vascular Surgery of the Serbian Clinical Centre in Belgrade in endovascular treatment of thoracic and abdominal aortic aneurysms. Methods. The procedure was performed in 33 patients (3 female and 30 male), aged from 42 to 83 years. Ten patients had a descending thoracic aorta aneurysm (three atherosclerotic, four traumatic - three chronic and one acute as a part of polytrauma, one dissected, two penetrated atherosclerotic ulcers), while 23 patients had the abdominal aortic aneurysm, one ruptured and two isolated iliac artery aneurysms. The indications for EVAR were isthmic aneurismal localisation, aged over 80 years and associated comorbidity (cardiac, pulmonary and cerebrovasular diseases, previous thoracotomy or multiple laparotomies associated with abdominal infection, idiopatic thrombocitopaenia). All of these patients had three or more risk factors. The diagnosis was established using duplex ultrasonography, angiography and MSCT. In the case of thoracic aneurysm, a Medtronic-Valiant? endovascular stent graft was implanted, while for the abdominal aortic aneurysm Medtronic-Talent? endovascular stent grafts with delivery systems were used. In three patients, following EVAR a surgical repair of the femoral artery aneurysm was performed, and in another three patients femoro-femoral cross over bypass followed implantation of aortouniiliac stent graft. Results. During procedure and follow-up period (mean 1.6 years), there were: one death, one conversion, one endoleak type 1, six patients with endoleak type 2 that disappeared during the follow-up period, one early graft thrombosis. No other complications, including aneurysm expansion, collapse, deformity and migration of the endovascular stent grafts, were registered. Conclusion. According to all medical and economic aspects, we recommend EVAR to treat acute traumatic thoracic aortic aneurysm, as well as in elderly and high-risk patients with abdominal or thoracic aneurysms, when open surgery is related to a significantly higher mortality and morbidity.

Endovascular Abdominal Aortic Aneurysm Repair in Patients with Challenging Anatomy: Utility of the Hybrid Endograft

Vascular ◽  
2004 ◽  
Vol 12 (2) ◽  
pp. 106-113 ◽  
Author(s):  
William D. Jordan ◽  
Thomas C. Naslund ◽  
Mark A. Adelman ◽  
Gene Simoni ◽  
Douglas J. Wirthlin
Keyword(s):  
Abdominal Aortic Aneurysm ◽  
Aortic Aneurysm ◽  
Endovascular Aneurysm Repair ◽  
Radiographic Evaluation ◽  
Covered Stents ◽  
Aneurysm Size ◽  
Abdominal Aortic ◽  
Aneurysm Repair

Commercially available aortic stent grafts differ in construction and clinical advantage such that creating hybrid endografts by combining components from different manufacturers is sometimes useful. We describe a multicenter experience using hybrid endografts to treat patients with challenging anatomy. Hospital records and office charts were reviewed from four institutions. Hybrid endografts were defined as those with two types of covered stents in continuity to treat an abdominal aortic aneurysm (AAA). Indications for hybrid grafts were defined by type of endoleak and whether an endoleak was expected or unexpected as determined by the preoperative radiographic evaluation. Endpoints include intraoperative endoleaks, late endoleaks, change in aneurysm size, and rupture. Hybrid endografts were used to treat AAA (endovascular aneurysm repair [EVAR]) in 90 patients, representing 7.9% of the total multicenter experience. In 7 patients (7.8%), a hybrid graft construction as a secondary procedure successfully corrected a type 1 endoleak. In the remaining 83 patients (92.2%), hybrid grafts were created at the time of original EVAR to treat expected challenging anatomy or unexpected endoleaks. Hybrid endografts corrected 88 (97.8%) type 1 endoleaks, but 2 patients (2.2%) persisted with a proximal type 1 leak requiring conversion. During follow-up of 1 to 24 months, computed tomography and ultrasound surveillance, available for 73 patients (81.1%), detected one unresolved distal type 1 (1.1%) and seven type 2 (7.8%) endoleaks. Aneurysm size decreased at least 0.5 cm in 23 of 50 patients (46.0%) at 6 months and in 19 of 31 patients (61.3%) at 12 months. Aneurysm size increased at least 0.5 cm in 4 of 50 patients (8.0%) at 6 months and in 1 of 31 patients (3.2%) at 12 months. There were no ruptures. Hybrid endografts have favorable early and intermediate results in the treatment of AAA. Long-term follow-up will be needed to confirm the absence of significant adverse biomaterial interaction and the effect on AAA exclusion. We advocate the use of hybrid endografts as endovascular therapy for patients whose anatomy may be unsuitable for a single endograft type.

Late Rupture of an Abdominal Aortic Aneurysm after Parodi's Endoprosthesis Replacement

Swiss Surgery ◽  
2001 ◽  
Vol 7 (4) ◽  
pp. 190-193 ◽  
Author(s):  
De Monti ◽  
Ghilardi ◽  
Gobatti ◽  
Labagnara ◽  
Scorza
Keyword(s):  
Abdominal Aortic Aneurysm ◽  
Aortic Aneurysm ◽  
Surgical Procedures ◽  
Aneurysm Rupture ◽  
Endovascular Surgery ◽  
Aortic Aneurysms ◽  
Retroperitoneal Haematoma ◽  
Abdominal Aortic ◽  
Prosthesis Replacement

Endovascular surgery as a whole, and specifically in the context of aortic aneurysms, is a very interesting methodology the potential of which is increasingly being recognized. Follow up information on patients who underwent these procedures will be critical to validate the different techniques which have been developed and to identify the most appropriate situations for this type of surgical procedures. The authors present a case of aortic aneurysm rupture who had undergone Parodi's endoprosthesis placement two years before. CT angiographic evaluation showed a wide endoleak due to distal stent detachment, a complete dislodging of the endoprosthesis itself and retroperitoneal haematoma. Prosthesis replacement through a laparotomic approach was carried out and the patient was discharged 10 days postoperatively, surgically cured.

scholarly journals Tratamento Endovascular do Aneurisma da Aorta Abdominal por Via Percutânea e Anestesia Local – One Day Surgery

2016 ◽  
Vol 29 (6) ◽  
pp. 381 ◽  
Author(s):  
Joel Sousa ◽  
Daniel Brandão ◽  
Paulo Barreto ◽  
Joana Ferreira ◽  
José Almeida Lopes ◽  
...  
Keyword(s):  
Abdominal Aortic Aneurysm ◽  
Aortic Aneurysm ◽  
Local Anesthesia ◽  
Day Surgery ◽  
Technical Success ◽  
Percutaneous Access ◽  
Abdominal Aortic ◽  
Abdominal Aortic Aneurism ◽  
Percutaneous Thrombin Injection

<p><strong>Introduction:</strong> To evaluate the results of the abdominal aortic aneurism endovascular treatment (EVAR), percutaneously and with local anesthesia, according to the concept of one day surgery.<br /><strong>Material and Methods:</strong> Unicentric, retrospective analysis of patients with aorto-iliac aneurysmal disease, consecutively treated by EVAR with percutaneous access trough the Preclose technique (pEVAR), according to the outpatient criteria, with one overnight stay in the hospital. The technical success, exclusion of the aneurysmal sac, endoleak, re-intervention and mortality were evaluated.<br /><strong>Results:</strong> Twenty consecutive patients (all male; mean age 74.65 years) were treated by EVAR with percutaneous access and local anesthesia, from which 95% (19) presented with abdominal aortic aneurysm and 5% (1) common iliac aneurysm. All implants were sucessfully performed, with an initial endoleak rate of 10% (2), determined by one type 1a endoleak successfully corrected intra-operatively and one type 2a endoleak diagnosed in the first imaging control, which sealed spontaneously on the second control. Initial technical success for percutaneous closure was 97.5%, with one case reported of femoral pseudo-aneurism, posteriorly treated by percutaneous thrombin injection. Median length of stay was one day [1-10], with a mean follow-up of 11.4 months [1-36]. Both the re-intervention and mortality rate are 0% for the selected period.<br /><strong>Conclusion:</strong> Our one day surgery model for the outpatient treatment of abdominal aortic aneurysm by the pEVAR technique is innovative, safe and effective, as long as the selection criteria are respected.</p>

Endovascular abdominal aortic aneurysm sealing: A systematic review of early outcomes

Vascular ◽  
2016 ◽  
Vol 25 (4) ◽  
pp. 423-429 ◽  
Author(s):  
Stephanie L Brown ◽  
Ayoola Awopetu ◽  
Michael S Delbridge ◽  
Philip W Stather
Keyword(s):  
Systematic Review ◽  
Abdominal Aortic Aneurysm ◽  
Aortic Aneurysm ◽  
Open Surgery ◽  
Emergency Setting ◽  
Technical Success ◽  
Abdominal Aortic ◽  
Aneurysm Repair ◽  
Sealing Device

Objectives There has been a clear move towards endovascular repair of abdominal aortic aneurysms owing to better peri-operative outcomes compared with open surgical repair. However, follow-up has continued to reveal relatively high rates of endoleaks and re-interventions. Improvements in endovascular stent-grafts aim to decrease these complications. This systematic review aims to determine the early outcomes of abdominal aortic aneurysm sealing. Methods Standard PRISMA guidelines were followed. A literature search was performed with the aim to extract any publication related to the endovascular aneurysm sealing device. Results The total number of patients in this systematic review of 11 studies is 684, with a mean age of 73.2 years, and 587 (88.0%) males. The majority were undergoing elective procedures ( n = 606, 91.0%), the remainder as emergencies ( n = 30, 4.5% as ruptures, n = 30, 4.5% as symptomatic). Technical success rate including emergency cases was 99.1%. Thirty-day mortality rate was 2.6% ( n = 17) including all cases, and 1.0% ( n = 6) including elective cases only. Thirty -day endoleak detection rate was 4.7% ( n = 31) including all cases, and 4.8% ( n = 29) including elective cases only. Thirty-day aneurysm-related re-intervention rate was 5.7% ( n = 38) including all cases, and 4.6% ( n = 28) including elective cases only. There was no conversion to open surgery within 30 days post-op in the elective cases. There were three delayed conversions to open surgery within 30 days and one report of stent migration causing rupture in the emergency setting. Conclusions This novel endovascular aneurysm-sealing device for abdominal aortic aneurysm repair has shown respectable early outcomes. Good technical success rates, in both elective and emergency settings, low rates of all-type endoleaks and low re-intervention rates have all been demonstrated. It is proving to be a safe alternative to open and endovascular aneurysm repair; however, longer term follow-up results are needed to assess the safety and effectiveness of the device in the long term.

Endovascular Treatment of Aortic Aneurysms in Finland: The First Four Years' Experience

2002 ◽  
Vol 91 (2) ◽  
pp. 155-159 ◽  
Author(s):  
P. S. Aho ◽  
G. Pimenoff ◽  
J. P. Salenius ◽  
S. Leinonen ◽  
K. Ylönen ◽  
...  
Keyword(s):  
Abdominal Aortic Aneurysm ◽  
Aortic Aneurysm ◽  
Endovascular Treatment ◽  
Aortic Aneurysms ◽  
Interventional Radiologist ◽  
Secondary Interventions ◽  
Abdominal Aortic ◽  
Short Time ◽  
Mid Term Results

Background and aims: In this study the results of endovascular treatment of aortic aneurysms in Finland are presented and compared to the results of the Eurostar registry. Material and methods: A total of 229 patients with aortic aneurysm were treated in five different Finnish centres during 1996–2000. The data of these patients were collected prospectively by surgeon or interventional radiologist involved. During the same period of time 2464 patients were registered in the Eurostar registry. Results: The procedure was performed successfully in 97 % of patients in Finland, and the 30-day mortality was 0,9 %. A graft limb thrombosis was detected in 9 % of the patients in Finland. A permanent primary endoleak at the first 30-day control was seen in 23 patients (10 %). During the follow-up 17 secondary endoleaks (7 %) were detected. A secondary intervention was necessary in 26 % of the patients. Three patients (1.3 %) had late rupture of the abdominal aortic aneurysm. Conclusions: According to the Finnish short-time results, endovascular treatment of aortic aneurysms is safe and associated with relatively low morbidity and mortality. The mid-term results are more disappointing with relatively many graft thromboses and endoleaks, and a frequent need of secondary interventions.

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