Performance of the Gore VBX Balloon Expandable Endoprosthesis as Bridging Stent-Graft in Branched Endovascular Aortic Repair for Thoracoabdominal Aneurysms

2021 ◽  
pp. 152660282110104
Author(s):  
Giovanni B Torsello ◽  
Apostolos Pitoulias ◽  
Sarah Litterscheid ◽  
Bärbel Berekoven ◽  
Giovanni-Federico Torsello ◽  
...  
Keyword(s):  
Learning Curve ◽  
Stent Graft ◽  
Primary Endpoint ◽  
Clinical Success ◽  
Aortic Aneurysms ◽  
Implantation Technique ◽  
Accurate Estimation ◽  
Target Vessel ◽  
Technical Success ◽  
Vessel Curvature

Purpose Bridging stent stability is crucial for efficacy and safety of branched aortic endovascular repair (bEVAR) of thoracoabdominal aortic aneurysms (TAAAs). In this study, we assess the performance of the new Viabahn Balloon-Expandable endoprosthesis (VBX) in bEVAR. Based on our learning curve we give recommendations for a safe and effective use of the device. Materials and Methods We prospectively collected the data of patients with TAAAs undergoing bEVAR between December 2017 and December 2019. All patients with implantation of at least 1 VBX stent-graft as bridging stent were included in our single-center analysis. Demographic, comorbidity, and computed tomography angiography (CTA) data of 112 patients were retrospectively evaluated. Primary endpoint was a composite of branch-related technical success and freedom from target vessel instability. Secondary endpoints were clinical and ongoing clinical success. Results Primary endpoint: technical success was achieved in all patients (100%) with a freedom from target vessel instability of 96.3% after a median follow-up of 18 months. Overall mortality was 13.4% (n=15) and 13 patients underwent secondary interventions, 12 of them are still alive and 1 suffered from aneurysm sac expansion, consequently an ongoing clinical success of 75.9% was reached. After modification of the implantation technique during the course of the study by selecting longer stent lengths after accurate estimation of vessel curvature and expected adaptation of the flexible endoskeleton to the specific anatomical conditions, no type Ic endoleaks were observed in the last 70 cases. Conclusions The VBX stent-graft can be safely used as bridging stent for branched thoracoabdominal repair. However, learning curve should be considered to avoid type Ic endoleak and edge stenosis. Based on this experience longer landing zones and 2-step deployment of VBX are useful for successful bridging also of challenging target vessels.

Operative and Midterm Outcomes of the Fenestrated Anaconda Stent-Graft in the Endovascular Treatment of Juxtarenal, Suprarenal, and Type IV Thoracoabdominal Aortic Aneurysms

2016 ◽  
Vol 23 (6) ◽  
pp. 930-935 ◽  
Author(s):  
Drosos Kotelis ◽  
Karina Schleimer ◽  
Christina Foldenauer ◽  
Houman Jalaie ◽  
Jochen Grommes ◽  
...  
Keyword(s):  
Stent Graft ◽  
Aortic Aneurysms ◽  
Mesenteric Arteries ◽  
Target Vessel ◽  
Technical Success ◽  
Type Iv ◽  
Aortic Pathology ◽  
Vessel Patency ◽  
Overall Mortality

Purpose: To report operative and midterm outcomes of fenestrated endovascular aneurysm repair (FEVAR) with the Anaconda device. Methods: A retrospective analysis was conducted of 39 consecutive patients (median age 74 years; 36 men) treated with the fenestrated Anaconda stent-graft between July 2011 and December 2015 at a single center. Indications for FEVAR were abdominal aortic aneurysms (AAAs) with neck anatomy unsuitable for a standard stent-graft. Median infrarenal neck length was 4 mm (range 0–9). Four (10%) patients presented with type IV thoracoabdominal aortic aneurysm (TAAA), 12 (31%) with suprarenal aneurysms, and 23 (59%) with juxtarenal aneurysms. Four (10%) patients had previous infrarenal aortic repair. Five (13%) patients had an infrarenal neck angulation >60°. A total of 106 fenestrations were incorporated into the stent-grafts (73 renal arteries, 25 superior mesenteric arteries, and 8 celiac trunks). Technical success, perioperative and midterm mortality and morbidity, target vessel patency, endoleaks, and reinterventions were documented. Results: Technical success was 95% (37/39). Three (8%) patients died in-hospital from mesenteric embolism in 2 and renal artery rupture with consequent multiorgan failure in 1. Two (5%) patients suffered an intraoperative embolic stroke. During a median follow-up of 33 months (range 4–55), adjunctive maneuvers were performed in 9 (23%) patients, including reintervention for type II endoleak with enlarged aneurysm sac in 2 (5%). Four additional patients died of causes unrelated to the aortic pathology (overall mortality 18%). In 34 (94%) of the 36 patients seen in follow-up, aneurysm sac size was stable or decreased. Target vessel stent patency was 99% (95/96). Conclusion: FEVAR with the Anaconda device delivers satisfactory short-term technical and clinical success rates in patients with juxtarenal, suprarenal, and type IV TAAA. Midterm efficacy and durability with respect to aneurysm sac regression and target vessel patency appear very good. Overall mortality and the need for reintervention were significant in this patient cohort.

scholarly journals Global Post-Market Clinical Follow-up of the Treovance Stent-Graft for Endovascular Aneurysm Repair: One-Year Results From the RATIONALE Registry

2018 ◽  
Vol 25 (6) ◽  
pp. 726-734 ◽  
Author(s):  
Raman Uberoi ◽  
Carlo Setacci ◽  
Mario Lescan ◽  
Antonio Lorido ◽  
David Murray ◽  
...  
Keyword(s):  
Stent Graft ◽  
Clinical Performance ◽  
Clinical Success ◽  
Endovascular Aneurysm Repair ◽  
Aortic Aneurysms ◽  
Type I ◽  
Technical Success ◽  
Major Morbidity ◽  
Aneurysm Repair

Purpose: To evaluate the safety and performance of the Treovance stent-graft. Methods: The global, multicenter RATIONALE registry ( ClinicalTrials.gov; identifier NCT03449875) prospectively enrolled 202 patients (mean age 73.0±7.8 years; 187 men) with abdominal aortic aneurysms (AAA) suitable for endovascular aneurysm repair (EVAR) using the Treovance. The composite primary safety endpoint was site-reported all-cause mortality and major morbidity. The primary efficacy outcome was clinical success. Further outcomes evaluated included technical success; stent-graft migration, patency, and integrity; endoleak; and aneurysm size changes. Results: Technical success was 96% (194/202); 8 patients had unresolved type I endoleaks at the end of the procedure. There was no 30-day mortality and 1% major morbidity (1 myocardial infarction and 1 bowel ischemia). Clinical success at 1 year was confirmed in 194 (96%) patients; 6 of 8 patients had new/persistent endoleaks and 2 had aneurysm expansion without identified endoleak. A total of 8 (4%) reinterventions were required during the mean 13.7±3.1 months of follow-up (median 12.8). At 1 year, the Kaplan-Meier estimate for freedom from reintervention was 95.6% (95% CI 91.4% to 97.8%). Other estimates were 95.5% (95% CI 91.7% to 97.6%) for freedom from endoleak type I/III and 97.4% (95% CI 94.2% to 98.9%) for freedom from aneurysm expansion. Thirteen (6.4%) patients died; no death was aneurysm related. Conclusion: The RATIONALE registry showed favorable safety and clinical performance of the Treovance stent-graft for the treatment of infrarenal AAAs in a real-world setting.

scholarly journals Technical approach and outcomes of failed infrarenal endovascular aneurysm repairs rescued with fenestrated and branched endografts

2019 ◽  
Vol 2 (1) ◽  
Author(s):  
Jesse Manunga ◽  
Larissa I. Stanberry ◽  
Peter Alden ◽  
Jason Alexander ◽  
Nedaa Skeik ◽  
...  
Keyword(s):  
Adverse Events ◽  
Stent Graft ◽  
Graft Patency ◽  
Hospital Length ◽  
Aortic Aneurysms ◽  
Hospital Length Of Stay ◽  
Type I ◽  
Technical Success ◽  
Vessel Patency ◽  
Major Adverse Events

Abstract Background Endovascular rescue of failed infrarenal repair (EVAR) has emerged as an attractive option to stent graft explantation. The procedure, however, is underutilized due to limited devices accessibility and the challenges associated with their implantation in this patient population. The purpose of this study was to report our outcomes and discuss our approach to rescuing previously failed infrarenal endovascular aneurysm repairs (EVAR) with fenestrated/branched endografts (f/b-EVAR). Methods A retrospective analysis of prospectively collected data of consecutive patients with failed EVAR rescued with f/b-EVAR at our institution from November 2013 to March 2019 was conducted. The study primary end point was technical success; defined as the implantation of the device with no type I a/b or type III endoleak or conversion to open repair. Secondary endpoints included major adverse events (MAEs), graft patency and reintervention rates. Results During this time, 202 patients with complex aortic aneurysms were treated with f/b-EVAR. Of these, 19 patients (Male: 17, mean age 79 ± 7 years) underwent repair for failed EVAR. The median time from failed repair to f/b-EVAR was 48 (30, 60) months. Treatment failure was attributed to stent graft migration in 9 (47.4%) patients, disease progression in 5 (26.3%), short initial neck in 3 (15.8%) and unable to be determined in 2 (10.5%). Three patients were treated urgently with surgeon modified stent graft. Technical success was achieved in 18 patients (95%), including two who had undergone emergent repair for rupture. Seventy-two targeted vessels (97.3%) were successfully incorporated. Sixteen (84.2%) patients required a thoracoabdominal repair to achieve a durable seal. Major adverse events (MAEs) occurred in 3 patients (15.7%) including paralysis and death in one (5.3%), compartment syndrome and temporary dialysis in another and laparotomy with snorkeling of one renal and bypass of the other in the third patient. Median (IQR) hospital length of stay was 3 (2, 4) days. Late reintervention, primary target vessel patency and primary assisted patency rates were 5.3%, 98.6% and 100%, respectively. Conclusion Implantation of f/b-EVAR in patients with failed previous EVAR is a challenging undertaking that can be performed safely with a high technical success and low reintervention rates.

scholarly journals E-nside Off-the-Shelf Inner Branch Stent Graft: Technical Aspects of Planning and Implantation

2021 ◽  
pp. 152660282110479
Author(s):  
Alexander Zimmermann ◽  
Anna-Leonie Menges ◽  
Zoran Rancic ◽  
Lorenz Meuli ◽  
Philip Dueppers ◽  
...  
Keyword(s):  
Radiation Dose ◽  
Stent Graft ◽  
Patient Selection ◽  
Endovascular Therapy ◽  
Aortic Aneurysms ◽  
Implantation Technique ◽  
Stent Grafts ◽  
Middle Segment ◽  
Technical Aspects ◽  
Fenestrated Stent Graft

Purpose This article aims to present all aspects regarding patient selection, planning, and implantation technique for a new off-the-shelf pre-cannulated multi-inner branch stent graft. The stent graft comes in 4 different versions with proximal diameters of 33 and 38 mm and distal diameters of 26 and 30 mm. The 4 inner branches are located in the middle segment, which has a diameter of 24 mm. Technique With inner branch technology, the field of application for the treatment of thoracoabdominal aortic aneurysms (TAAA) has been further extended. In addition to routine use in elective cases the pre-cannulation of the inner branches predisposes especially for emergencies. Pre-cannulation is intended to reduce the time to cannulation and the radiation dose. All steps of planning, stent-graft deployment, and cannulation of the inner branches are described in detail. Conclusion The E-nside stent graft represents a promising new endovascular therapy in the treatment of acute and elective TAAA. By using inner branch technology, this endograft combines the advantages of fenestrated and branched stent grafts. Indication, planning, and implantation require experience in branched and fenestrated stent graft technology.

Aortic Arch and Descending Thoracic Aortic Aneurysms: Experience with Stent Grafting for Second-Stage “Elephant Trunk” Repair

Vascular ◽  
2005 ◽  
Vol 13 (1) ◽  
pp. 5-10 ◽  
Author(s):  
Alfio Carroccio ◽  
David Spielvogel ◽  
Sharif H. Ellozy ◽  
Robert A. Lookstein ◽  
Iris Y. Chin ◽  
...  
Keyword(s):  
Aortic Arch ◽  
Stent Graft ◽  
Clinical Success ◽  
Perioperative Complications ◽  
Aortic Aneurysms ◽  
Elephant Trunk ◽  
Stent Grafting ◽  
Thoracic Aortic Aneurysms ◽  
Second Stage ◽  
Antegrade Approach

Reconstruction of aortic arch and descending thoracic aortic aneurysms (TAAs) is technically challenging and associated with significant morbidity and mortality. We report our experience with extensive TAAs using a two-stage “elephant trunk” repair, with the second stage completed using an endovascular stent graft (ESG). Over 6 years, 111 patients underwent ESG treatment of TAAs at Mount Sinai Medical Center. Twelve of these patients were referred for ESG placement for the second stage of elephant trunk reconstruction because comorbidities placed them at high risk of open surgical repair. Our database was analyzed for technical and clinical success and perioperative complications. The mean follow-up was 11.8 months (range 1–64 months). Twelve patients (five women and seven men) with a mean age of 69 ± 10 years underwent repair of their distal aortic arch and descending TAAs. These aneurysms included nine atherosclerotic aneurysms, one pseudoaneurysm, and two penetrating atherosclerotic ulcers. Three patients were symptomatic. Stent graft repair was technically successful in 91.7% or 11 of 12 patients. Excessive aortic arch tortuosity resulted in failure to deploy a stent graft in one patient. An antegrade approach through the open elephant trunk was used in two patients with severe iliac occlusive disease. Endoleaks (type 2) were identified in two patients with no aneurysm expansion; however, a 14 mm expansion over 1 year occurred in a patient with no identifiable endoleak. One early mortality occurred in a patient with a ruptured 6 cm infrarenal AAA after successful exclusion of the 8 cm TAA. Second-stage elephant trunk reconstruction of an extensive TAA using an ESG is effective in the short term. Its long-term durability remains to be determined.

scholarly journals Graft Complexity–Related Outcomes of Fenestrated Endografting for Abdominal Aortic Aneurysms

2017 ◽  
Vol 24 (2) ◽  
pp. 230-236 ◽  
Author(s):  
Kyriakos Oikonomou ◽  
Piotr Kasprzak ◽  
Wilma Schierling ◽  
Reinhard Kopp ◽  
Karin Pfister
Keyword(s):  
Operative Mortality ◽  
Perioperative Complications ◽  
Endovascular Aneurysm Repair ◽  
Aortic Aneurysms ◽  
Target Vessel ◽  
Technical Success ◽  
Midterm Results ◽  
Significant Difference ◽  
Vessel Patency

Purpose: To report the outcomes of fenestrated endovascular aneurysm repair (FEVAR) and compare early and midterm results in relation to stent-graft complexity. Methods: Between August 2006 and December 2014, 141 consecutive patients (mean age 72±7.6 years, range 50–89; 120 men) were treated electively with FEVAR for short-neck, juxtarenal, or suprarenal aortic aneurysms. Forty-five patients treated with stent-grafts featuring renal-only fenestrations were assigned to group A, while 96 patients receiving additional fenestrations for the superior mesenteric and/or celiac arteries were assigned to group B. Technical success, operative mortality and morbidity, target vessel patency, endoleak, reintervention, and survival were compared between the groups. Survival, target vessel stent patency, and reintervention during follow-up were estimated by Kaplan-Meier analysis; the estimates are presented with the 95% confidence interval (CI). Results: Technical success was achieved in 135 (95.7%) patients. Overall 30-day operative mortality was 3.5% (5/141). Perioperative complications occurred in 16 (12.1%) patients. Mean follow-up was 33±23 months. Overall estimated survival was 85.1% (95% CI 79.1% to 91.1%) at 1 year and 75.8% (95% CI 68.2% to 83.5%) at 3 years. Freedom from reintervention was 90.6% (95% CI 85.6% to 95.6%) at 1 year and 79.2% (95% CI 71% to 87.5%) at 3 years. There was no statistically significant difference between the groups in terms of perioperative mortality or morbidity, endoleak, survival, target vessel patency, or reintervention. Conclusion: The use of FEVAR for juxta- and suprarenal aneurysms is associated with low 30-day mortality/morbidity and high midterm efficacy. So far, perioperative and midterm results are not affected by the use of more complex fenestrated designs.

scholarly journals Early results of a low-profile stent-graft for thoracic endovascular aortic repair

PLoS ONE ◽  
2020 ◽  
Vol 15 (11) ◽  
pp. e0240560
Author(s):  
Hazem El Beyrouti ◽  
Mario Lescan ◽  
Marco Doemland ◽  
Migdat Mustafi ◽  
Florian Jungmann ◽  
...  
Keyword(s):  
Stent Graft ◽  
Aortic Rupture ◽  
Clinical Success ◽  
Intramural Hematoma ◽  
Aortic Aneurysms ◽  
Elephant Trunk ◽  
Landing Zone ◽  
Early Results ◽  
Low Profile

Purpose To assess outcomes of a low-profile thoracic stent-graft in the treatment of thoracic aortic pathologies. Methods A retrospective analysis of all consecutive patients with aortic thoracic pathologies treated with the RelayPro device in two university hospitals between October 2018 and July 2019. Results 23 patients (65% men; mean age 63.4 ± 15 years) were treated. Pathologies included aortic dissections (n = 10), 5 residual type A (22%) and 5 type B (22%), 6 degenerative aortic aneurysms (26%), 4 penetrating aortic ulcers (17%), and aortic erosion, intramural hematoma and aortic rupture (n = 1 and 4% in each case). Two cases (9%) were emergent and two urgent. Proximal landing was achieved in zones 0 (4%), 1 (4%), 2 (43%), and 3 (26%). Five grafts were frozen elephant trunk extensions. Technical success was 100% with accurate device deployment in the intended landing zone of the aortic arch in all 23 patients and with no Ia/III endoleaks and three (13%) type II endoleaks. Apposition was adequate in 96%. Two patients had post-implantation syndromes (one fever, one leukocytosis). Mean follow-up was 11.6 ± 3.7 months (range, 2–16) with no other complications, secondary interventions or conversions to open surgery. There was no 30-day mortality and no aortic-related mortality; all-cause mortality was 4% during follow-up. Conclusion A 3–4 French reduced profile in the current generation of stent-grafts facilitates TEVAR particularly in patients with smaller vessels access. Early safety and effectiveness outcomes are favorable, even in endpoints such as deployment accuracy and apposition which may be surrogates for longer-term clinical success and durability.

scholarly journals Unibody Endograft Using AFX 2 for Less Invasive and Faster Endovascular Aortic Repair: Protocol for a Multicenter Nonrandomized Study

10.2196/16959 ◽  
2020 ◽  
Vol 9 (4) ◽  
pp. e16959
Author(s):  
Roberto Silingardi ◽  
Pasqualino Sirignano ◽  
Francesco Andreoli ◽  
Wassim Mansour ◽  
Mattia Migliari ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Clinical Success ◽  
Aortic Aneurysms ◽  
Endovascular Aortic Repair ◽  
Intraoperative Radiation ◽  
Nonrandomized Study ◽  
Aortic Repair ◽  
Number Of Patients

Background Since the introduction of endovascular aortic repair (EVAR) for treatment of abdominal aortic aneurysms (AAAs), progressive improvements in results have been achieved. However, conventional bifurcated stent grafts have been proven to have a nonnegligible risk of failure and secondary intervention, principally due to the lack of adequate proximal sealing. The unique AFX 2 Endovascular AAA System (Endologix, Irvine, CA) unibody device, which provides different sealing and fixation features compared with conventional devices, seems to overcome these limitations. Objective The aim of this study is to evaluate intraoperative, perioperative, and postoperative results in patients treated with the AFX 2 Endovascular AAA System endografts for elective AAA repair in a large cohort of consecutive patients. Methods All eligible EVAR patients will be included in this observational, multicenter, prospective, nonrandomized study. The number of patients to be enrolled is 500. Results The primary endpoint of the study is to evaluate the technical and clinical success of EVAR with unibody endografts in short- (90-day), mid- (1-year), and long-term (5-year) follow-up periods. The following secondary endpoints will also be addressed: operative time, intraoperative radiation exposure, contrast medium usage, AAA sac shrinkage at 12-month and 5-year follow-up, and any potential role of patients’ baseline characteristics and device configuration on primary endpoint. The actual start date of the investigation was November 2019. The final patient is expected to be treated by the end of December 2020, and the estimated study completion date is December 2025. Conclusions This study will provide verified real-world data on AAAs treated by AFX 2 endografts and followed for a long-term interval. International Registered Report Identifier (IRRID) PRR1-10.2196/16959

scholarly journals Efficacy of Primary Stent-Graft Placement in the Treatment of Vascular Access Graft Outflow Tract Stenosis

2019 ◽  
Vol 54 (1) ◽  
pp. 25-35
Author(s):  
Edoardo Macchi ◽  
Federico Fontana ◽  
Alessandro Beneventi ◽  
Marco Curti ◽  
Chiara Tagliaferri ◽  
...  
Keyword(s):  
Stent Graft ◽  
Clinical Success ◽  
Transluminal Angioplasty ◽  
Primary Patency ◽  
Outflow Tract ◽  
Secondary Patency ◽  
Technical Success ◽  
Venous Outflow ◽  
Surgical Thrombectomy ◽  
Early Restenosis

Purpose: The aim of this study is to present our personal experience using covered nitinol stent-graft in the treatment of outflow tract stenosis of arteriovenous grafts (AVGs) for hemodialysis access. Materials and Methods: Between May 2015 and October 2017, we retrospectively evaluated 36 (24 males, 12 females; mean age: 65.6 years) patients with AVGs on hemodialysis who underwent percutaneous angioplasty followed by endovascular stent-graft deployment for the treatment of stenosis of the venous outflow of the AVG. Indication for treatment included early restenosis (<3 months after previous percutaneous transluminal angioplasty [PTA]), long stenosis (stenoses >50% extending for a length >5 cm), and recoil of the stenosis after PTA performed with a noncompliant high-pressure balloon. Of 36 patients, 27 (75%) required surgical thrombectomy prior to endovascular procedure. Technical success, clinical success, primary and secondary patency, and safety were evaluated. Results: Technical success was 100%, and clinical success was 94.4%. Primary patency was 94.4%, 72.2%, 63%, 45.9%, and 45.9% at 1, 3, 6, 12, and 18 months (average: 215 days, range: 9-653 days); secondary patency was 94.4% and 86.1% at 1 and 3 months; 80.4% at 6, 12, and 18 months; and 53.6% at 24 months (average: 276.8 days, range: 9-744 days). No deaths were registered. Conclusions: In selected cases, the use of stent-graft represents an effective and safe solution for the treatment of stenotic complications of the venous outflow of AVGs, even in the setting of access thrombosis.

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