Long-term Results of Thoracic Endovascular Aortic Repair Using a Low-Profile Stent-Graft

2020 ◽  
pp. 152660282095241
Author(s):  
Efthymios Beropoulis ◽  
Stefano Fazzini ◽  
Martin Austermann ◽  
Giovanni B. Torsello ◽  
Sarah Damerau ◽  
...  

Purpose To evaluate the long-term results associated with the Zenith Alpha thoracic stent-graft, which was designed to address challenging access vessel anatomy. Materials and Methods A retrospective analysis was conducted of 44 consecutive patients (mean age 72.5±8.3 years; 25 men) treated in a single center between August 2010 and October 2014 with a minimum follow-up of 5 years in survivors. The Zenith Alpha thoracic stent-graft was used to treat thoracic aortic aneurysms (n=37), thoracoabdominal aortic aneurysm (n=5), or penetrating aortic ulcer (n=2). Ten patients (23%) were American Society of Anesthesiologists class IV, and 9 (20%) had nonelective procedures. Access vessel anatomy was demanding (mean minimum diameter 5.4 mm, tortuosity index 1.3). The primary endpoint at 5 years was ongoing clinical success (freedom from aneurysm-/procedure-related death, secondary intervention, type I or III endoleak, infection, thrombosis, aneurysm expansion, rupture, or conversion). Secondary endpoints were freedom from all-cause mortality, device migration, stent fractures, fabric erosions, endoleaks, neurological events, and access vessel complications. Results The ongoing clinical success was 84% (37 of 44 patients) owing to 4 aneurysm-related deaths (9%), 3 type I or III endoleaks (1 in a deceased patient), and 1 aneurysm expansion without detectable endoleak. There were 3 access vessel complications (7%), and no postoperative neurological events. Migration was observed in 2 cases (5%). There were no stent fractures or fabric tears. Conclusion Despite the alterations in stent-graft design and material to reduce profile, the Zenith Alpha thoracic stent-graft showed favorable long-term results even in multimorbid patients with demanding iliac anatomy.

2011 ◽  
Vol 54 (3) ◽  
pp. 915
Author(s):  
Paul J. Foley ◽  
Frank J. Criado ◽  
Mark A. Farber ◽  
Christopher J. Kwolek ◽  
Manish Mehta ◽  
...  

2005 ◽  
Vol 12 (1) ◽  
pp. 89-97 ◽  
Author(s):  
R. Scott Mitchell ◽  
Shin Ishimaru ◽  
Frank J. Criado ◽  
Marek P. Ehrlich ◽  
Krassi Ivancev ◽  
...  

2002 ◽  
Vol 9 (4) ◽  
pp. 481-487 ◽  
Author(s):  
Hemant Ingle ◽  
Guy Fishwick ◽  
Andrew Garnham ◽  
Matthew M. Thompson ◽  
Peter R.F. Bell

Purpose: To assess the long-term results of a homemade aortomonoiliac polytetrafluoroethylene (PTFE) device used for endovascular abdominal aortic aneurysm (AAA) repair. Methods: A vascular audit database was interrogated to identify 58 consecutive AAA patients (all men; median age 73 years, range 56–88) who underwent aortomonoiliac stent-graft repair. AAAs were eligible for endovascular treatment if the infrarenal neck was ≥15 mm long and ≤28 mm in diameter. Results: Nine (15.5%) procedures failed, 8 during the procedure and 1 on the 7th postoperative day; 8(13.8%) patients were converted, but one was unfit for surgery. There was one intraprocedural stroke, and 3 (5.2%) patients died within 30 days. The primary success rate (no conversion or mortality) was 79.3%. Over a median follow-up of 45 months (range 23–80), there were 3 (5.2%) graft occlusions, 1 kink requiring stent implantation, and 1 expanding sac without identifiable endoleak. There were 11 (19.0%) endoleaks in 10 patients, 9 type I leaks (2 proximal) and 1 type II. One patient with a distal type I endoleak (treated) also exhibited a type III leak at 2 years, but the sac size had not increased. There was a 40% incidence of bilateral buttock claudication, which was serious in only 1 patient. The long-term survival rate by Kaplan-Meier life-table analysis was 57% at 4 years. Conclusions: Implantation of an aortomonoiliac PTFE device can be achieved with good primary success, and the stent-graft seems durable over the long term. Proximal type I endoleaks are rare, but distal endoleaks from the contralateral common iliac artery can be solved by using a different covered stent.


2018 ◽  
Vol 25 (6) ◽  
pp. 726-734 ◽  
Author(s):  
Raman Uberoi ◽  
Carlo Setacci ◽  
Mario Lescan ◽  
Antonio Lorido ◽  
David Murray ◽  
...  

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.


VASA ◽  
2013 ◽  
Vol 42 (5) ◽  
pp. 340-349 ◽  
Author(s):  
Ivan Kralj ◽  
Irene Boos ◽  
Uwe Müller-Bühl

Background: Advances in stent technology have widened the field of indications for stent treatment of femoro-popliteal artery lesions, however the use of stents in bending arterial segments is restricted because some first- and second-generation nitinol stent designs did not respond well to the mechanical forces of femoro-popliteal segments in motion which pose a substantial risk of stent fracture inducing in-stent-stenosis. New generation nitinol stents are supposed to overcome these limitations but long-term results are rare. Patients and methods: In forty-five patients (mean age 68 y, range 50 - 85) with peripheral arterial disease (TASC II A-C, Rutherford category 2 - 5) forty-six lesions of the superficial femoral artery (37) or popliteal artery (9) were treated [25 high-grade stenoses, mean length 53 mm (range 30 - 145 mm); 21 chronic total occlusions, mean length 74 mm (range 30 - 180 mm)]. 74 % of lesions were located in the mobile bending arterial segments in the distal femoral or the popliteal segment. Clinical reevaluation performed at discharge, at 6, 12, 24, and 36 months included at least the measurement of ankle-brachial index (ABI) and duplex sonography. Results: Procedural success rate was 100 %. At 6, 12, 24, and 36 months, cumulative primary patency rate was 93.5 %, 84.8 %, 80.5 %, and 74.3 % (SE<10); freedom from target lesion revascularization rate was 95.7 %, 89.2 %, 84.9 %, and 79.3 % (SE<10); Rutherford category and ABI improved in all patients and clinical success was maintained in more than 85 % of patients. Conclusions: Sustained technical and clinical success and good clinical long-term results were achieved with Misago™ nitinol stent implantation in femoro-popliteal lesions with moderate risk for in-stent-stenosis, and in the distal femoral and popliteal mobile segment.


Vascular ◽  
2020 ◽  
pp. 170853812098112
Author(s):  
Cassra N Arbabi ◽  
Navyash Gupta ◽  
Ali Azizzadeh

Objectives Thoracic endovascular aortic repair (TEVAR) is the standard of care for descending thoracic aortic aneurysms (DTAA), and newer generation stent grafts have significant design improvements compared to earlier generation devices. Methods We report the first commercial use of the Medtronic Valiant Navion stent graft for treatment of an 85-year-old woman with a 5.8 cm DTAA and a highly tortuous thoracic aorta. Results A percutaneous TEVAR was performed using a two-piece combination of the Valiant Navion FreeFlo and CoveredSeal stent graft configurations for zones 2–5 coverage. The devices were successfully delievered through highly tortuous anatomy and deployed, excluding the entire length of the aneurysm with precise landing, excellent apposition and no evidence of endoleak. The patient tolerated the procedure well and has had no stent graft-related complications through one-year follow-up. Conclusions Design enhancements such as a lower profile delivery system, better conformability, and a shorter tapered tip are some of the improvements to this third-generation TEVAR device. Coupled with the multiple configuration options available, this gives physicians a better tool to treat thoracic aortic pathologies in patients with challenging anatomy. The early results are encouraging, and evaluation of long-term outcomes will continue.


2019 ◽  
Vol 2 (1) ◽  
Author(s):  
Jesse Manunga ◽  
Larissa I. Stanberry ◽  
Peter Alden ◽  
Jason Alexander ◽  
Nedaa Skeik ◽  
...  

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.


Sign in / Sign up

Export Citation Format

Share Document