Early Clinical Outcomes of the Active Seal Technology of the AFX Endovascular Aortic Aneurysm System With the VELA Cuff for Patients With a Conical Proximal Neck

2022 ◽  
pp. 152660282110709
Author(s):  
Naoki Fujimura ◽  
Hideaki Obara ◽  
Takaaki Nagano ◽  
Yukihisa Ogawa ◽  
Taira Kobayashi ◽  
...  

Purpose: To evaluate the efficacy of the Active Seal technology employed in the AFX endovascular aortic aneurysm system (AFX), during endovascular aneurysm repair (EVAR) in patients with abdominal aortic aneurysms (AAAs) having a conical proximal neck. Materials and Methods: A retrospective analysis of the EVAR for AAA with a conical proximal neck using the AFX was performed at 17 Japanese hospitals between January 2016 and August 2020. The conical proximal neck was defined as a cone-shaped proximal neck, with more than 10% diameter increase within a 15 mm length at the proximal landing zone. All anatomical analyses were performed in the core laboratory, and cases with parallel walls within the proximal neck adequate for the landing zone were excluded from the study. Results: This study included 53 patients, but only 39 patients (mean age, 76.6 ± 6.7 years; 87.0% males; mean aneurysm diameter, 52.0 ± 8.0 mm) were analyzed after being characterized as having a pure conical neck by the core laboratory. The mean proximal neck diameters at the lower renal artery and proximal edge of the aneurysm were 20.0 ± 2.9 mm and 27.5 ± 4.9 mm, respectively. The mean proximal neck length was 21.5 ± 6.0 mm. Instructions for use violations other than the conical neck were observed in 15 patients (38.5%). The VELA cuff was used in all cases; however, additional proximal cuff was required in 9 more cases (23.1%). The Active Seal technology was able to significantly extend the proximal sealing zone from 21.5 ± 6.0 to 26.0 ± 12.2 mm ( p = .047). Thirty-six patients completed the 12-month follow-up (one patient was lost to follow-up, and 2 patients died from causes unrelated to the aneurysm), and there were no type-1a and 3 endoleaks with only one reintervention (2.6%) related to type 1b endoleak in the 12-month period. Furthermore, there was no significant enlargement of the proximal neck diameter at 12 months (at 1 month: 20.6 ± 3.4 mm and at 12 months: 21.3 ± 3.8 mm; p = .420). Conclusion: The Active Seal technology of the AFX significantly extended the proximal seal zone and no type-1a endoleak and proximal neck dilation was observed in patients with conical proximal neck at 12 months.

2018 ◽  
Vol 26 (1) ◽  
pp. 54-61 ◽  
Author(s):  
Asma Yafawi ◽  
Richard G. McWilliams ◽  
Robert K. Fisher ◽  
Andrew England ◽  
Maria Karouki ◽  
...  

Purpose: To investigate the incidence and extent of stent frame movement after endovascular aneurysm sealing (EVAS) in the abdominal aorta and its relationships to aneurysm growth and the instructions for use (IFU) of the Nellix endograft. Methods: A retrospective single-center study was conducted to review the clinical data and computed tomography (CT) images of 75 patients (mean age 76±7.6 years; 57 men) who underwent infrarenal EVAS and had a minimum 1-year follow-up. The first postoperative CT scan at 1 month and the subsequent scans were used to measure the distances between the proximal end of the stent frames and a reference visceral vessel using a previously validated technique. Device migration was based on the Society of Vascular Surgery definition of >10-mm downward movement of either Nellix stent frame in the proximal landing zone; a more conservative proximal displacement measure (downward movement ⩾4 mm) was also recorded. Patients were categorized according to adherence to the old (2013) or new (2016) Nellix IFU. Aneurysm diameter was measured for each scan; a change ⩾5 mm was deemed indicative of aneurysm growth. Results: Over a median follow-up of 24 months (range 12–48), proximal displacement ⩾4 mm occurred in 42 (56%) patients and migration >10 mm in 16 (21%), with similar incidences in the right and left stent frames. Proximal displacement was significantly more frequent among patients whose anatomy did not conform to any IFU (p=0.025). Presence of aneurysm growth ⩾5 mm was observed in 14 (19%) patients and was significantly associated with proximal displacement ⩾4 mm (p=0.03). Conclusion: Infrarenal EVAS may be complicated by proximal displacement and migration, particularly when performed outside the IFU. The definition of migration used for endovascular aneurysm repair may be inappropriate for EVAS; a new consensus on definition and measurement technique is necessary.


2009 ◽  
Vol 137 (1-2) ◽  
pp. 10-17 ◽  
Author(s):  
Lazar Davidovic ◽  
Momcilo Colic ◽  
Igor Koncar ◽  
Dejan Markovic ◽  
Dusan Kostic ◽  
...  

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.


2019 ◽  
Vol 56 (5) ◽  
pp. 993-1000 ◽  
Author(s):  
Enrico Gallitto ◽  
Gianluca Faggioli ◽  
Rodolfo Pini ◽  
Chiara Mascoli ◽  
Stefano Ancetti ◽  
...  

Abstract OBJECTIVES Our objective was to report the outcomes of fenestrated/branched endovascular aneurysm repair of thoraco-abdominal aortic aneurysms (TAAAs) with endografts. METHODS Between January 2010 and April 2018, patients with TAAAs, considered at high surgical risk for open surgery and treated by Cook-Zenith fenestrated/branched endovascular aneurysm repair, were prospectively enrolled and retrospectively analysed. The early end points were 30-day/hospital mortality rate, spinal cord ischaemia and 30-day cardiopulmonary and nephrological morbidity. Follow-up end points were survival, patency of target visceral vessels and freedom from reinterventions. RESULTS Eighty-eight patients (male: 77%; mean age: 73 ± 7 years; American Society of Anesthesiologists 3/4: 58/42%) were enrolled. Using Crawford’s classification, 43 (49%) were types I–III and 45 (51%) were type IV TAAAs. The mean aneurysm diameter was 65 ± 15 mm. Custom-made and off-the-shelf endografts were used in 60 (68%) and 28 (32%) cases, respectively. Five (6%) patients had a contained ruptured TAAA. The procedure was performed in multiple steps in 42 (48%) cases. There was 1 (1%) intraoperative death. Five (6%) patients suffered spinal cord ischaemia with permanent paraplegia in 3 (3%) cases. Postoperative cardiac and pulmonary complications occurred in 7 (8%) and 12 (14%) patients, respectively. Worsening of renal function (≥30% of baseline level) was detected in 11 (13%) cases, and 2 (2%) patients required haemodialysis. The 30-day and hospital mortality rates were 5% and 8%, respectively. The mean follow-up was 36 ± 22 months. Survival at 12, 24 and 36 months was 89%, 75% and 70%, respectively. The patency of target visceral vessels at 12, 24 and 36 months was 92%, 92% and 92%, respectively. Freedom from reinterventions at 12, 24 and 36 months was 85%, 85% and 83%, respectively. CONCLUSIONS The endovascular repair of TAAAs with fenestrated/branched endovascular aneurysm repair is feasible and effective with acceptable technical/clinical outcomes at early/midterm follow-up.


Vascular ◽  
2017 ◽  
Vol 25 (6) ◽  
pp. 657-665 ◽  
Author(s):  
Vinay Kansal ◽  
Sudhir Nagpal ◽  
Prasad Jetty

Objective Endovascular aneurysm repair for ruptured abdominal aortic aneurysm is being increasingly applied as the intervention of choice. The purpose of this study was to determine whether survival and reintervention rates after ruptured abdominal aortic aneurysm vary between endograft devices. Methods This cohort study identified all ruptured abdominal aortic aneurysms performed at The Ottawa Hospital from January 1999 to May 2015. Data collected included patient demographics, stability index at presentation, adherence to device instructions for use, endoleaks, reinterventions, and mortality. Kruskal–Wallis test was used to compare outcomes between groups. Mortality outcomes were assessed using Kaplan–Meier survival analysis, and multivariate Cox regression modeling. Results One thousand sixty endovascular aneurysm repairs were performed using nine unique devices. Ninety-six ruptured abdominal aortic aneurysms were performed using three devices: Cook Zenith ( n = 46), Medtronic Endurant ( n = 33), and Medtronic Talent ( n = 17). The percent of patients presented in unstable or extremis condition was 30.2, which did not differ between devices. Overall 30-day mortality was 18.8%, and was not statistically different between devices ( p = 0.16), although Medtronic Talent had markedly higher mortality (35.3%) than Cook Zenith (15.2%) and Medtronic Endurant (15.2%). AUI configuration was associated with increased 30-day mortality (33.3% vs. 12.1%, p = 0.02). Long-term mortality and graft-related reintervention rates at 30 days and 5 years were similar between devices. Instructions for use adherence was similar across devices, but differed between the ruptured abdominal aortic aneurysm and elective endovascular aneurysm repair cohorts (47.7% vs. 79.0%, p < 0.01). Notably, two patients who received Medtronic Talent grafts underwent open conversion >30 days post-endovascular aneurysm repair ( p = 0.01). Type 1 endoleak rates differed significantly across devices (Cook Zenith 0.0%, Medtronic Endurant 18.2%, Medtronic Talent 17.6%, p = 0.01). Conclusion Although we identified device-related differences in endoleak rates, there were no significant differences in reintervention rates or mortality outcomes. Favorable outcomes of Cook Zenith and Medtronic Endurant over Medtronic Talent reflect advances in endograft technology and improvements in operator experience over time. Results support selection of endograft by operator preference for ruptured abdominal aortic aneurysm.


2019 ◽  
Vol 26 (3) ◽  
pp. 350-358 ◽  
Author(s):  
Noriyasu Morikage ◽  
Takahiro Mizoguchi ◽  
Yuriko Takeuchi ◽  
Takashi Nagase ◽  
Makoto Samura ◽  
...  

Purpose: To evaluate the advantages of chimney endovascular aneurysm repair (chEVAR) using an Endurant stent-graft with uncovered balloon-expandable stents (BES) for patients with juxtarenal aortic aneurysms. Materials and Methods: Twenty-two patients (mean age 78.5±9.0 years; 13 men) who underwent chEVAR using Endurant and uncovered BES between January 2014 and December 2017 were analyzed retrospectively. The maximum aneurysm diameter was 59.1±11.9 mm, and the proximal neck length was 5.2±2.9 mm. Of the 22 cases, 9 (40%) involved proximal neck angulation and 9 (40%) had a conical neck. Single and double chimneys were performed using BES in 19 and 3 cases, respectively. In 2 cases, an additional self-expanding covered stent was used inside the uncovered BES. Results: The technical success was 91% (20/22) as 2 (9%) cases showed minor type Ia endoleak. No postoperative systemic complications or acute renal dysfunction (Acute Kidney Injury Network classification stage 2 or higher) were observed. The mean radiologic observation period was 16.1±9.6 months, and no aneurysm expansion (>5 mm) was observed during this time. The mean maximum aneurysm diameter decreased to 52.9±10.2 mm (p<0.001 vs preoperative), with an individual mean sac regression of 6.2±5.9 mm. Overall primary chimney stent patency was 100%. One of the 2 cases of intraoperative type Ia endoleak resolved at the 6-month imaging, and no new type Ia endoleaks developed in any cases at follow-up. No additional treatment- or aneurysm-related events were observed. Conclusion: Short-term outcomes of chEVAR using Endurant with uncovered BES have been favorable when covered stents were unavailable, and it can be useful for high-risk patients with juxtarenal aortic aneurysms.


Author(s):  
Nicolas Heinz von der Höh ◽  
Philipp Pieroh ◽  
Jeanette Henkelmann ◽  
Daniela Branzan ◽  
Anna Völker ◽  
...  

Abstract Purpose To report the challenging therapeutic approach and the clinical outcome of patients with pyogenic spondylodiscitis transmitted due to infected retroperitoneal regions of primary infected mycotic aortic aneurysms (MAAs) or secondary infected aortic stent grafts after endovascular aneurysm repair (EVAR). Methods Between 2012 and 2019, all patients suffering from spondylodiscitis based on a transmitted infection after the EVAR procedure were retrospectively identified. Patient data were analysed regarding the time between primary and secondary EVAR infection and spondylodiscitis detection, potential source of infection, pathogens, antibiotic treatment, complications, recovery from infection, mortality, numeric rating scale (NRS), COBB angle and cage subsidence. Results Fifteen patients with spondylodiscitis transmitted from primary or secondary infected aortic aneurysms after EVAR were included. The median follow-up time was 8 months (range 1–47). Surgery for spondylodiscitis was performed in 12 patients. In 9 patients, the infected graft was treated conservatively. MAAs were treated in 4 patients first with percutaneous aortic stent graft implantation followed by posterior surgery of the infected spinal region in a two-step procedure. Infection recovery was recorded in 11 patients during follow-up. The overall mortality rate was 27% (n = 4). The mean pain intensity improved from an NRS score of 8.4 (3.2–8.3) to 3.1 (1.3–6.7) at the last follow-up. Conclusion EVAR was used predominantly to treat primary infected MAAs. Secondary infected grafts were treated conservatively. Independent of vascular therapy, surgery of the spine led to recovery in most cases. Thus, surgery should be considered for the treatment of EVAR- and MAA-related spondylodiscitis.


2020 ◽  
pp. 145749692091726
Author(s):  
A. Sonetto ◽  
S. Laukontaus ◽  
L. Vikatmaa ◽  
P. Aho ◽  
M. Venermo

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.


Vascular ◽  
2016 ◽  
Vol 25 (1) ◽  
pp. 92-100 ◽  
Author(s):  
Yang Yaoguo ◽  
Chen Zhong ◽  
Kou Lei ◽  
Xiao Yaowen

Objective We reviewed data pertaining to fenestrated endograft technique and chimney stent repair of complex aortic aneurysm for comparative analysis of the outcomes. Methods A comprehensive search of relevant databases was conducted to identify articles in English, related to the treatment of complex aortic aneurysm with fenestrated endovascular aneurysm repair and chimney stent repair, published until January 2015. Results A total of 42 relevant studies and 2264 patients with aortic aneurysm undergoing fenestrated endovascular aneurysm repair and chimney stent repair were included in our review. A total of 4413 vessels were involved in these processes. The cumulative 30-day mortality was 2.4% and 3.2% ( p = 0.459). The follow-up aneurysm-related mortality was 1.4% and 3.2% ( p = 0.018), and target organ dysfunction was 5.0% and 4.0% in fenestrated endovascular aneurysm repair and chimney stent repair, respectively ( p = 0.27). A total of 156 vessels showed restenosis or occlusion after primary intervention (3.6% and 3.4% in fenestrated endovascular aneurysm repair and chimney stent repair, respectively, p = 0.792). The cumulative type I endoleak was 2.0% (38/1884) after fenestrated endovascular aneurysm repair compared with 3.4% (13/380) after chimney stent repair ( p = 0.092), and the type II endoleak was 5.4% (102/1884) and 5.3% (20/380), respectively ( p = 0.905). Approximately, 1.1% and 1.6% increase in aneurysm was observed following fenestrated endovascular aneurysm repair and chimney stent repair, respectively ( p = 0.437). The re-intervention frequency was 205 and 19 cases after fenestrated endovascular aneurysm repair and chimney stent repair, respectively (11.7%, 5.6%, p = 0.001). Conclusions Fenestrated endovascular aneurysm repair and chimney stent repair are safe and effective in treating patients with complex aortic aneurysm. A higher aneurysm-related mortality was observed in chimney stent repair while fenestrated endovascular aneurysm repair was associated with a higher re-intervention rate.


2019 ◽  
Vol 29 (6) ◽  
pp. 944-949
Author(s):  
Andrzej Juraszek ◽  
Bartosz Rylski ◽  
Stoyan Kondov ◽  
Johannes Scheumann ◽  
Maximilian Kreibich ◽  
...  

Abstract OBJECTIVES Our goal was to report our results of late surgical conversion after endovascular aneurysm repair (EVAR). METHODS Variables analysed included baseline data, preinterventional anatomy, type of endovascular intervention, indications for conversion, operative technique, postoperative complications and follow-up survival rate. RESULTS Between April 2011 and May 2018, 16 patients with late complications after EVAR underwent open surgical conversion at our institution. The mean age was 73.6 [standard deviation (SD) 8.9] years. There were 3 (18.8%) female patients. In 15 patients, the indication for primary EVAR was abdominal aortic aneurysm, and in 1 patient, chronic abdominal aortic dissection. Five patients underwent secondary EVAR service interventions for endoleak treatment between the index EVAR and the final secondary surgical conversion. Thirteen patients underwent surgery in an elective setting and 3 patients underwent emergency surgery. The mean time from EVAR to open surgical conversion was 6.31 (SD 4.0) years (range 1.2–16.0 years). The most common indication for conversion was endoleak formation (n = 12, 75%), followed by 3 cases of aortic rupture (1 patient with primary type 1 endoleak) and 2 cases of stent graft infection—1 with and 1 without an aortoduodenal fistula. One patient died during emergency open surgery of cardiopulmonary instability. Three patients developed postoperative renal dysfunction with recovery of their renal function before discharge. The in-hospital mortality rate was 12.5%. The median follow-up was 16.5 months (interquartile range 21 months). Freedom from death and aortic reintervention was 100%, respectively. After careful review of the index computed tomography scans for EVAR, the majority of failures could have been anticipated due to trade-offs with regard to length, diameter, morphology, shape and angulation of the proximal and/or distal landing zone. CONCLUSIONS Despite being a challenging operation, late surgical conversion after EVAR yields excellent results with regard to outcome and freedom from the need for further aortic interventions. An anticipative strategy adhering to current recommendations for using or refraining from using EVAR in patients with anatomical challenges will help reduce the need for secondary surgical conversions and keep them to minimum.


2014 ◽  
Vol 17 (3) ◽  
pp. 146
Author(s):  
Osman Tansel Darcin ◽  
Mehmet Kalender ◽  
Ayse Gul Kunt ◽  
Okay Guven Karaca ◽  
Ata Niyazi Ecevit ◽  
...  

<p><b>Background:</b> Thoracoabdominal aortic aneurysms (TAAA) present a significant clinical challenge, as they are complex and require invasive surgery. In an attempt to prevent considerably high mortality and morbidity in open repair, hybrid endovascular repair has been developed by many authors. In this study, we evaluated the early-term results obtained from this procedure.</p><p><b>Methods:</b> From November 2010 to February 2013, we performed thoracoabdominal hybrid aortic repair in 18 patients. The mean age was 68 years (12 men, 6 women). All of the patients had significant comorbidities. Follow-up computed tomography (CT) scans were performed at 1 week, 3 months, 6 months, and annually thereafter.</p><p><b>Results:</b> All patients were operated on in a staged procedure and stent graft deployment was achieved. Procedural success was achieved in all cases. All patients were discharged with complete recovery. No endoleaks weres detected in further CT examination.</p><p><b>Conclusion:</b> Our results suggests that hybrid debranching and endovascular repair of extensive thoracoabdominal aneurysms represents a suitable therapeutic option to reduce the morbidity and mortality of TAAA repair, particularly in those typically considered at high risk for standard repair.</p>


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