Endoleak outcomes with different stent-graft generations in a 25-years thoracic endovascular aortic repair experience

Vascular ◽  
2021 ◽  
pp. 170853812110514
Author(s):  
Stefano Gennai ◽  
Nicola Leone ◽  
Luigi A Maria Bartolotti ◽  
Tea Covic ◽  
Antonio Lauricella ◽  
...  

Introduction To compare endoleak outcomes after thoracic endovascular aneurysm repair (TEVAR) with different stent-graft generations into long-term follow-up. Design retrospective, observational, and single-center cohort study. Methods TEVAR procedures performed between November 1995 and December 2020 were analyzed. The primary endpoint of this study was the freedom from endoleak (type I/III) in four stent-graft generations during the follow-up period. The first generation (GEN1) included: Vanguard; AneuRx and Talent; Stentor; Excluder; Endologix; EndoFit. The second generation (GEN2) included: TAG and TX. The third (GEN3) included: Relay Plus; Valiant Captivia; Zenith Alpha and custom-made. The fourth (GEN4) included: Relay Pro; Conformable C-TAG; Navion; E-Vita; Najuta; Nexus; standard and custom-made thoraco-abdominal devices. Nonaortic and aorta-related survival was considered as secondary outcome. Results A total of 509 TEVAR were included with a 44.3 ± 42.5 months mean follow-up. Freedom from endoleak at 5 years was 65.6%, 61.4%, 76.2%, and 69.1% for GEN1, GEN2, GEN3, and GEN4, respectively ( p = 0.368). The first two generations demonstrated a higher endoleak rate when compared with the two most recent ones (27.2 vs 18.2%, respectively; p = 0.043). GEN1 was an independent risk factor ( p = 0.014) and GEN4 was an independent protective factor ( p = 0.001) for endoleak. GEN1 was found to be a risk factor for type-Ia endoleak ( p = 0.059). GEN4 demonstrated a protective association regarding type-Ib endoleak ( p = 0.012). Overall survival was 75.3%, 44.4%, 27.2%, and 17.6% at 1, 5, 10, and 15 years, respectively. Survival distinguished as non-related versus aortic-related was 86.7% vs 23.5%, 52.7% vs 9.8%, 32.9% vs 2.0%, 21.2% vs 0% at 1, 5, 10, and 15 years, respectively ( p< 0.000). Conclusion Endoleak occurred in a non-negligible percentage of TEVAR patients. A significant reduction of endoleak incidence over evolving stent-grafts generations was registered. Newer stent-graft generations demonstrated better long-term endoleak. Data about long-term outcomes require ongoing updates to prove both the reliability and the durability of newer stent-graft generations.

Vascular ◽  
2021 ◽  
pp. 170853812110627
Author(s):  
Gino Gemayel GG ◽  
Michel Montessuit MM ◽  
Anouche Gemayel GA

Objectives We represent two cases of late proximal type I endoleak following EVAR with aneurysm expansion that were treated with a custom-made graft with inner branches. Methods Two patients of 87 and 82 years old were operated by EVAR 6 and 8 years ago for abdominal aortic aneurysm. Both had proximal type I endoleak with aneurysm sac expansion. Open surgery had a high risk, and a proximal aortic extension with a simple aortic cuff was not possible neither because previous EVAR grafts were already at the level of the renal arteries. A custom-made endograft with inner branches was planned as a fenestrated graft was not technically possible. Results We successfully treated both patients using a custom-made graft with four inner branches from Jotec (Cryolife, Kennesaw, GA). Three months’ follow-up CT scan did not show any endoleaks. All target vessels were patent with good conformability of the bridging stents. Conclusion The treatment of proximal type I endoleak using inner branches’ endografts is feasible. This novel technology might broaden the indications for complex aortic repair in a group of patients where fenestrated endografts are not possible.


2019 ◽  
Vol 53 (6) ◽  
pp. 515-519
Author(s):  
Toshiya Nishibe ◽  
Toru Iwahashi ◽  
Kentaro Kamiya ◽  
Masaki Kano ◽  
Keita Maruno ◽  
...  

We present 3 cases of type IIIb endoleak after endovascular aneurysm repair (EVAR) using the Zenith stent graft system. Type III endoleak, like type I endoleak, is a high-pressure, high-risk leak that increases sac pressure up to or even above arterial pressure, and is associated with an increased frequency of open conversions or risk of aneurysm rupture. Type IIIb endoleak is rare but there is much concern that the incidence of type IIIb endoleak is likely to increase hereafter; the mechanism of type IIIb endoleak is deterioration of graft fabric in conjunction with stent sutures. Type IIIb endoleak is difficult to diagnose before rupture. The possibility of type IIIb endoleak should be highly suspected when the continued growth of an excluded aneurysm sac without direct radiologic evidence is observed during follow-up. Type IIIb endoleak can be repaired by relining of the stent graft with additional stent grafts.


Vascular ◽  
2008 ◽  
Vol 16 (5) ◽  
pp. 253-257 ◽  
Author(s):  
Evert J. Waasdorp ◽  
Joost A. van Herwaarden ◽  
Rob H.W. van de Mortel ◽  
Frans L. Moll ◽  
Jean-Paul P.M. de Vries

This study evaluated the value of computed tomographic angiography (CTA) early after an endovascular aneurysm repair (EVAR) in relation to CTA 3 months after EVAR. We retrospectively reviewed all elective EVAR patients with available postprocedural and 3-month follow-up CTAs who were treated between 1996 and 2006. CTAs were analyzed for EVAR-related complications in terms of endoleaks, migration, and stent graft thrombosis. Secondary procedures and other complications within a 4-month time interval after EVAR were noted and analyzed for any association with the postprocedural CTA. During the study period, 291 patients (275 men), with a mean age of 71 years, underwent elective EVAR. All had postprocedural and 3-month follow-up CTAs, which detected 93 (32%) endoleaks (8 type I, 84 type II, 1 type III) and 1 stent graft thrombosis. These findings resulted in four secondary interventions (one interposition cuff, two extension cuffs, one conversion). All reinterventions were successfully done in an elective setting. During the first 3 postoperative months, five other reinterventions were required for acute ischemia in four patients (three Fogarty procedures, one femorofemoral crossover bypass) or groin infection in one patient. Eight patients died, but none of the deaths were related to abdominal aortic aneurysm or EVAR (four cardiac, two pulmonary, one gastric bleeding, one carcinoma). At 3 months, 43 endoleaks (3 type I, 40 type II), 3 stent graft thromboses, and 1 stent graft migration were seen. In two patients (0.7%), a new endoleak was diagnosed compared with the postprocedural CTAs. In 287 (99%) of 291 patients, the postprocedural CTA did not influence our treatment policy in the first 3 months after EVAR. More than half of the early endoleaks were self-limiting, and new endoleaks were seen in only two patients (< 1%) at the 3-month follow-up CTA. After an uneventful EVAR procedure, it is safe to leave out the early postprocedural CTA.


2003 ◽  
Vol 10 (3) ◽  
pp. 397-405 ◽  
Author(s):  
Pierre Alric ◽  
Robert J. Hinchliffe ◽  
Marie-Christine Picot ◽  
Bruce D. Braithwaite ◽  
Shane T.R. MacSweeney ◽  
...  

Purpose: To determine in a retrospective analysis the incidence of renal impairment (RI) following endovascular repair (EVR) of abdominal aortic aneurysm (AAA), to assess the morbidity and mortality in endograft patients with preoperative RI, and to examine the impact of suprarenal stent-grafts on renal function. Methods: From March 1994 to October 2001, 315 AAA patients (289 men; mean age 72.4±7.0 years) undergoing EVR were entered prospectively into a vascular registry. The patients received either an in-house custom-made stent-graft or one of several commercially made devices implanted with infrarenal or suprarenal fixation. Renal function was monitored by serum creatinine measurements prior to discharge and at 3, 6, and 12 months and annually thereafter. Preoperative RI was defined as a serum creatinine > 130 μmol/L and/or long-term dialysis. Postoperative RI referred to a >20% increase in the serum creatinine over baseline. Additional deterioration of renal function in patients with preoperative RI was referred to as postoperatively worsened RI. Results: Of the 315 patients treated, 220 (69.8%) were considered high risk (ruptured AAA or ASA grade III or IV). Sixty-nine (21.9%) patients had preoperative RI (6 [1.9%] on preoperative dialysis). A suprarenal stent-graft was used in 169 (53.7%) patients and infrarenal stent-graft in the remaining 146 (46.3%). The mean follow-up was 30.1 ±22.7 months. Postoperative RI occurred in 53 (16.8%) patients (24 [7.6%] transient, 29 [9.2%] persistent). Patients with preoperative RI had a significantly higher incidence of postoperatively worsened RI (37.7% versus 11.0%, p<0.0001) and a higher mortality related to RI (7.2% versus 1.6%, p=0.02). Suprarenal fixation had no influence on the incidence of RI, on perioperative mortality, or on mortality related to RI. The only significant predictive factor of postoperative RI was preoperative RI (risk ratio 5.09, 95% CI 2.38 to 10.87, p=0.0001). Conclusions: Endovascular AAA repair may lead to persistent postoperative RI in nearly 10% of cases, especially in patients with preoperative RI. Suprarenal stent-graft fixation does not seem to have any deleterious effect on renal function. Further long-term studies are required to confirm the innocuous nature of transrenal stent placement.


Author(s):  
Sabino Luzzi ◽  
Mattia Del Maestro ◽  
Renato Galzio

AbstractThe advent of flow diverter (FD) stents has apparently reduced the role of microneurosurgery for paraclinoid aneurysms despite sparse high-quality evidence about their long-term effects.The present study critically reviews the overall results of a microneurosurgical series of 57 paraclinoid aneurysms.Of these aneurysms, 47.4% were regular in size while 19.3 were giant. Barami type I was predominant. In 21 aneurysms a hemorrhagic onset occurred. Pterional approach with intradural anterior clinoidectomy was preferred by far. Clipping was possible in 91.2% of aneurysms and a high-flow bypass was the choice in five cases. An mRS of 0–2 was achieved in 77.3% of patients, typically <50 years old.Visual field appeared improved or unchanged in 36.3% and 63.6% of the symptomatic patients, respectively. In 76.1% of incidental aneurysms, campimetry was unaffected by surgery.A complete aneurysm exclusion was achieved in 93% of cases using a single procedure. No recurrences were documented on an average follow-up of 54.1 ± 34 months.Microneurosurgery is still a valuable, definitive, and durable option for Barami type Ia, Ib, or II paraclinoid aneurysm, especially in patients <50 years old and visually symptomatic. Conditions other than these are ideal candidates for FD stents.


2018 ◽  
Vol 25 (4) ◽  
pp. 480-491 ◽  
Author(s):  
Maaike A. Koenrades ◽  
Almar Klein ◽  
Anne M. Leferink ◽  
Cornelis H. Slump ◽  
Robert H. Geelkerken

Purpose: To provide insight into the evolution of the saddle-shaped proximal sealing rings of the Anaconda stent-graft after endovascular aneurysm repair (EVAR). Methods: Eighteen abdominal aortic aneurysm patients were consecutively enrolled in a single-center, prospective, observational cohort study (LSPEAS; Trialregister.nl identifier NTR4276). The patients were treated electively using an Anaconda stent-graft with a mean 31% oversizing (range 17–47). According to protocol, participants were to be followed for 2 years, during which 5 noncontrast electrocardiogram-gated computed tomography scans would be conducted. Three patients were eliminated within 30 days (1 withdrew, 1 died, and a third was converted before stent-graft deployment), leaving 15 patients (mean age 72.8±3.7 years; 14 men) for this analysis. Evolution in size and shape (symmetry) of both proximal infrarenal sealing rings were assessed from discharge to 24 months using dedicated postprocessing algorithms. Results: At 24 months, the mean diameters of the first and second ring stents had increased significantly (first ring: 2.2±1.0 mm, p<0.001; second ring: 2.7±1.1 mm, p<0.001). At 6 months, the first and second rings had expanded to a mean 96.6%±2.1% and 94.8%±2.7%, respectively, of their nominal diameter, after which the rings expanded slowly; ring diameters stabilized to near nominal size (first ring, 98.3%±1.1%; second ring, 97.2%±1.4%) at 24 months irrespective of initial oversizing. No type I or III endoleaks or aneurysm-, device-, or procedure-related adverse events were noted in follow-up. The difference in the diametric distances between the peaks and valleys of the saddle-shaped rings was marked at discharge but became smaller after 24 months for both rings (first ring: median 2.0 vs 1.2 mm, p=0.191; second ring: median 2.8 vs 0.8 mm; p=0.013). Conclusion: Irrespective of initial oversizing, the Anaconda proximal sealing rings radially expanded to near nominal size within 6 months after EVAR. Initial oval-shaped rings conformed symmetrically and became nearly circular through 24 months. These findings should be taken into account in planning and follow-up.


2020 ◽  
Vol 27 (3) ◽  
pp. 462-467
Author(s):  
Konstantinos Tigkiropoulos ◽  
Kyriakos Stavridis ◽  
Ioannis Lazaridis ◽  
Evangelos Bontinis ◽  
Ioulia Zournatzi ◽  
...  

Purpose: To report outcomes of elective endovascular aneurysm repair (EVAR) using the Anaconda stent-graft in a tertiary vascular center. Materials and Methods: A retrospective study was conducted of 271 patients (mean age 71.5 years; 260 men) who underwent elective EVAR for abdominal aortic aneurysm using the Anaconda stent-graft from January 2006 to January 2017. Median aneurysm diameter was 58 mm (range 50–90). All patients were anatomically suitable for EVAR according to the 2003 version of the instructions for use. Follow-up included computed tomography angiography at 1, 6, and 12 months and yearly thereafter for the first 4 years and then every 2 years. Primary outcomes included technical success and 30-day aneurysm-related mortality and complications; secondary outcomes were overall and aneurysm-related mortality and aneurysm-related morbidity in follow-up. Results: The Anaconda stent-graft was implanted successfully in all patients. Primary and secondary technical success rates were 99.6% and 100%, respectively. Three patients (1.1%) died within 30 days of causes unrelated to the aneurysm, while 15 patients (5.5%) suffered perioperative complications. Median follow-up was 72 months (range 14–141). The overall type I endoleak rate was 4.7% (11 proximal, 2 distal). Late aneurysm-related complications were observed in 48 patients (17.3%); aneurysm-related mortality was 1.4% (n=4). Non-aneurysm-related mortality was 21.0% (n=57). Freedom from reintervention was 95.2% at 1 year, 98% at 2 years, and 90% at 6 years. There was no significant difference in the overall limb graft occlusion rate between the second- and third-generation devices. Conclusion: Results in our cohort study demonstrate that the Anaconda stent-graft has satisfactory early and late results with low aneurysm-related mortality.


2019 ◽  
Vol 2019 ◽  
pp. 1-5
Author(s):  
Jiasheng Xu ◽  
Yu Zhou ◽  
Jingjing Guo ◽  
Yu Huang ◽  
Yangkai Jiang ◽  
...  

Objective. To assess the efficacy and short- and mid-term results of endovascular surgery and hybrid surgical procedures in treatment of complex aortic dissection. Methods. Clinical data of 90 patients with complex aortic dissection admitted from June 2012 to June 2018 were retrospectively analyzed. Among the patients, 60 cases were male and 30 cases were female, and their ages were ranged from 32 to 79, with an average age of 55 years old; different endovascular techniques and/or hybrid procedures were performed in these patients. Results. Technical success rate was 100% for the entire group of patients. Type I endoleak occurred in 8 patients immediately after stent-graft placement, which in 2 cases disappeared after a proximal Cuff placement, and the other cases received no special treatment. Follow-up was conducted from 1 month to 72 months, with an average of 36.3 months, and no stent-graft migration or organ ischemia was noted. In the follow-up patients, no type I endoleak occurred but type II endoleak was found in 2 cases, which were cured without treatment; no patient had paraplegia. Conclusion. Endovascular surgery and hybrid procedures have demonstrable mid- and long-term efficacy in treatment of complex aortic diseases. However, this conclusion still requires multicenter, large-sample studies to further confirm.


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.


2019 ◽  
Vol 53 (6) ◽  
pp. 458-463
Author(s):  
Rosa Marie Andersen ◽  
Benjamin S. B. Rasmussen ◽  
Ulrich Halekoh ◽  
Sten Langfeldt ◽  
Hossein Mohit Mafi ◽  
...  

Background: Few long-time follow-up studies describe all complications, treatment outcome of complications, and mortality in relation to endovascular aneurysm repair (EVAR). The purpose of this study was to evaluate the incidence and treatment outcome including mortality of radiological visible complications related to the EVAR procedure at a single center with up to 10 years’ surveillance. Materials and Methods: Patients treated with EVAR from March 2006 to March 2016 at a Danish university hospital, 421 in total, were included. Patient and aneurysm characteristics, follow-up, and secondary intervention data were collected from a national database and medical records. Follow-up computed tomography angiography and plain abdominal X-ray reports were reviewed for complications. Scans and X-rays with suspected complications were evaluated by an interventional radiologist. Results: A total of 172 complications in 147 patients, mainly in the beginning of the follow-up period, were found; 35% had a least one complication. The main part of complications (62%) was type II endoleaks, followed by stent graft stenosis (11%), type I endoleaks (9%), and stent graft occlusion (7%). A total of 66 (38%) complications, observed in 55 patients, were treated with reintervention, of which 77% were treated with endovascular procedures and 23% with surgical treatment, that is, 13% of all studied patients had a complication that required a reintervention. The remaining 2 of the 3 complications were treated conservatively. We found no increased all-cause mortality in connection with having a complication including those requiring reintervention. Conclusion: We presented a 10-year single-center study of EVAR. Many patients treated with EVAR had a radiological visible complication, mainly in the beginning of the follow-up period. Only a smaller fraction required reintervention and having a reintervention-requiring complication was not connected to increased mortality.


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