Target Visceral Vessels Patency Research Articles

The Gore Viabahn balloon-expandable stent graft as bridging stent in complex endovascular aortic procedures at 3-years performs better in fenestrations

Complex endovascular procedures are now recognized as the gold standard treatments for extensive aortic diseases. Bridging stents (covered stents used to couple the aortic graft to the visceral vessels) play a pivotal role, yet there is currently no dedicated device available on the market. The aim of the study was to evaluate the midterm performance of the Gore Viabahn balloon-expandable (VBX) stent graft as a bridging stent for target visceral vessels (TVVs). Data from all consecutive patients who underwent a fenestrated and branched endovascular aortic repair and received the VBX stent graft as a bridging stent between July 2018 and September 2022 were prospectively collected and subsequently analyzed retrospectively. Primary end points included freedom from TVV instability and freedom from TVV-related reinterventions, both overall and in comparison between branched and fenestrated graft configurations. Secondary end points were overall survival, procedure and TVV-related (in an intent-to-treat basis) technical success, freedom from type IC/IIIC endoleak, and freedom from TVV patency loss. Sixty-three patients were treated with a fenestrated and branched endovascular aortic repair using the VBX stent graft as a bridging stent, of whom 47 (74.6%) presented an atherosclerotic aneurysm, 7 (11.1%) a post-dissecative aneurysm, and 9 (14.3%) an anastomotic pseudoaneursym or a type IA endoleak in a previous endovascular aorticrepair. Included in the aortic repair were 231 of 243 (95.1%) total visceral vessels. The intraoperative requirement of 13additional VBX stent grafts determined a TVV-related technical success of 94.4%. The mean follow-up was 26.1±16.4months. The estimated overall survival at 36 months was 73%± 7.5%. The estimated rates at 36 months for freedom from type IC/IIIC endoleaks and TVV primary patency were 90.6%± 3.9% and 99%± 0.7%, respectively. The estimated rate at 36 months for freedom from TVV instability was 92.1%± 3% and did not differ between branched and fenestrated configurations, whereas freedom from TVV-related reinterventions was 90.6%± 3.1% and significantly in favor of fenestrations (69.4% vs 96.8%, P< .001). Multivariate analyses confirmed fenestrated configuration as a protective factor against TVV-related reinterventions (hazard ratio: 0.079; 95% confidence interval: 0.016-0.403). The VBX stent graft proves to be a reliable bridging stent for complex aortic procedures involving both fenestrated and branched endografts. Although immediate results are deemed satisfactory, they favor fenestrations regarding the need of reinterventions through 3 years. The success of the procedure heavily relies on a thorough understanding of the unique characteristics of this stent.

New Preloaded System for Renal and Visceral Arteries in Fenestrated Endografting.

The New Preloaded System (NPS) for renal/visceral arteries (TVVs) is an emerging technology in fenestrated endografting (FEVAR) that allows TVVs cannulation and stenting through the same access of the endograft main body. However, only few preliminary experiences are currently available in the literature. The aim of this study is to report the outcomes of NPS-FEVAR in juxta/para-renal (J/P-AAAs) and thoracoabdominal (TAAAs) aneurysms repair. This is a prospective (NCT05224219), single-center/observational study of patients submitted to NPS-FEVAR for J/PAAAs and TAAAs between 2019 and 2022 (July). Definitions and outcomes were evaluated according to the current SVS-reporting standard. Technical success (TS) and TS preloaded related, spinal cord ischemia (SCI), and 30-day mortality were assessed as early endpoints. Survival, freedom from reinterventions (FFRs), and freedom from TTVs-instability (FFTVVs-instability) were analyzed during follow-up. Among 157 F/B-EVAR cases, 74 (47%) NPS-FEVAR were planned and enrolled in the study [48 (65%) J/P-AAAs; 26 (35%) TAAAs]. The main indication for NPS-FEVAR was the presence of a hostile iliac axis (54%-73%) or the necessity of expeditious pelvic/lower-limb reperfusion for SCI prevention in TAAAs (20%-27%). Overall, 292 TVVs were accommodated by 289 fenestrations and 3 branches; 188 of 289 (65%) fenestrations were preloaded. NPS-FEVAR configuration was from "below" and "from below to above" in 28 (38%) and 46 (62%) cases, respectively. TS and TS preloaded system-related was 96% (71/74) and 99% (73/74), respectively. Target visceral vessels patency at the completion angiography was 99% (290/292). Failures were 2 renal arteries loss and 1 massive bleeding from a percutaneous closure system breakage. The latter patient developed postoperative multiorgans failure and died on the fifth postoperative day, causing only 30-day/in-hospital mortality (1.3%). One (1.3%) patient with a JAAA and preoperative bilateral occlusion of the hypogastric arteries suffered SCI. The median follow-up was 14 (IQR: 8) months. The estimated 3-year survival was 91% with no aneurysm-related mortality during follow-up. The estimated 3-year FFR and FFTVVs-instability were 85 and 92%, respectively. New preloaded system FEVAR is a safe and effective option in the treatment of J/PAAAs and TAAAs in the presence of hostile iliac access or to guarantee an expeditious pelvic/lower limb reperfusion, leading to satisfactory results in terms of TS, early and mid-term clinical outcomes. New preloaded system for fenestrated and branched endografting allows to increase the feasibility of the advanced endovascular aortic repair in challenging iliac access, thoracoabdominal aneurysm repair and reduce difficulties in target visceral vessels cannulation.

Inner branched complex aortic repair outcomes from a national multicenter registry using the E-xtra design platform

BackgroundComplex aortic pathology still represents an open issue in contemporary endovascular management, with continuous technological advancement being introduced in practice over time aiming to improve outcomes. Thus far, the dualism between the fenestrated and branched configuration for visceral artery revascularization is yet unsolved, with each approach having its own pros and cons. The inner branched technology for endovascular aneurysm repair (iBEVAR) aims to take the best out of both strategies, offering wide applicability and stable bridging stent sealing. The objective of this study was to evaluate the early outcomes obtained with a single manufacturer custom-made inner-branched endograft in a multicenter Italian experience. MethodsAll patients consecutively treated with E-xtra design devices in three Italian facilities were enrolled. Anatomic characteristics and perioperative data were analyzed. The main objective was to asses technical and clinical success after iBEVAR. Secondary end points were overall survival, aortic-related mortality, target visceral vessel (TVV) patency, and freedom from target vessel instability during follow-up. ResultsFrom 2016 to 2021, 45 patients were treated with an E-xtra design device revascularizing at least one visceral vessel through an inner branch. The mean age at the time of the procedure was 71.1 ± 9.3 years and 77.8% were males. The total number of target visceral arteries to be bridged with an inner branch was 159. The extent of aortic repair was thoracoabdominal in 91.1% of the cases. Technical success was achieved in 93.3% of the procedures (42/45) with all failures owing to a type I endoleak at final angiography. Each TVV was successfully connected to the graft’s main body as planned without complications. Following their intervention, five patients developed spinal cord ischemia and in three of these cases symptoms persisted after discharge (6.7%). At 30 days clinical success was 93.3% (42/45). No death as well as no TVV thrombosis occurred within 30 days from the primary procedures. The mean follow-up was 22.8 ± 14.2 months. The Kaplan-Meier estimate of overall survival and TVV patency at 36 months were 83.9% and 95.9%, respectively. ConclusionsInner branches seem to be a promising technology in the complex aortic repair landscape, with an applicability ranging from type II thoracoabdominal aneurysm to type I endoleak repair after infrarenal endografting. Whether iBEVAR could offer results comparable with those provided by fenestrated/branched endovascular aneurysm repair in terms of target vessel patency and stent stability is yet to be established and further studies are, therefore, needed.

Urgent endovascular repair of thoracoabdominal aneurysms using an off-the-shelf multibranched endograft.

Our goal was to report outcomes of the endovascular repair of urgent thoracoabdominal aortic aneurysms (TAAAs) using the Cook Zenith t-Branch off-the-shelf multibranched endograft. Between 2010 and 2020, we collected patients with TAAAs who received an urgent endovascular repair using the Cook Zenith t-Branch (had a rupture, symptoms or diameter >80 mm). Thirty-day mortality, spinal cord ischaemia (SCI) and clinical success were assessed as early outcomes. Freedom from reintervention, target visceral vessel patency and survival were considered during follow-up. Sixty-five cases were managed using the Cook Zenith t-Branch for 27 (42%) TAAA ruptures, 8 (12%) symptomatic TAAAs and 30 (46%) asymptomatic TAAAs with a diameter >80 mm. Crawford's extent I-II-III and IV were noted in 54 (83%) and 11 (17%), respectively. Eleven (17%) patients had SCI with 3 (5%) cases of permanent paraplegia. Postoperative dialysis (P = 0.04) and ruptured TAAAs (P = 0.05) were associated with SCI. Sixteen (25%) patients had reinterventions within the first 30 days postoperatively. The 30-day mortality was 14% (9). Ruptured TAAAs (P = 0.05) and technical failures (P = 0.01) were correlated with in-hospital mortality. Clinical success was 78% (51 patients). The mean follow-up was 18 ± 14 months. Survival at 24 months was 47% with no late TAAA-related deaths. Patients with ruptured TAAAs had lower survival than those who did not have ruptured TAAAs (52% vs 60% at 1 year; P = 0.05). Target visceral vessel patency and freedom from reintervention at 24 months were 89% and 60%, respectively. An off-the-shelf multibranched endograft is safe and effective for treating urgent TAAAs. Postoperative SCI and 30-day mortality are satisfactory for this challenging clinical scenario. The early reintervention rate is not negligible. Midterm survival is low, especially in patients with a ruptured TAAA; therefore, accurate patient selection is mandatory.

Preoperative and postoperative predictors of clinical outcome of fenestrated and branched endovascular repair for complex abdominal and thoracoabdominal aortic aneurysms in an Italian multicenter registry

ObjectiveComplex aortic aneurysms (juxtarenal aortic aneurysms [JAAA], pararenal aortic aneurysms [PAAAs], thoracoabdominal aortic aneurysms TAAAs) are treated with increasing frequency through fenestrated and branched endovascular repair (F/B-EVAR); however, the outcome of these procedures is usually reported separately by single experiences and wider overviews are not frequent. The aim of this study was therefore to report an Italian experience analyzing the results obtained in four academic centers to evaluate the predictors of outcomes. MethodsBetween 2008 and 2019, all consecutive patients undergoing F/B-EVAR in four Italian university centers were recorded prospectively and analyzed retrospectively. Preoperative comorbidities and postoperative complications were classified according with the Society for Vascular Surgery reporting standard. Postoperative complications and 30-day/in-hospital mortality were assessed as early outcomes. Survival, freedom from reinterventions and target visceral vessels patency were assessed as follow-up outcomes by Kaplan-Meier analysis. Risk factors for 30-day/in-hospital mortality and spinal cord ischemia (SCI) were determined by multivariate analysis. Risk factors for follow-up mortality and reinterventions were evaluated by Cox regression model. ResultsFive hundred ninety-six patients underwent F/B-EVAR for 124 JAAAs (21%), 121 PAAAs (20%), and 351 TAAAs (59%). Elective and urgent procedures were performed in 520 (87%) and 76 (13%) cases, respectively. Postoperative cardiac, pulmonary, and renal complications were reported in 41 (7%), 50 (8%), and 80 (13%) patients, respectively. Seven bowel ischemia (1%) and 23 cerebrovascular complications (4%) occurred. Forty-seven (8%) patients suffered SCI with 17 cases (3%) of permanent paraplegia. Crawford's extent I-II-III TAAAs (odds ratio [OR], 13.41; 95% confidence interval [CI], 1.77-101.65; P = .012) and postoperative renal complications (OR, 3.84; 95% CI, 1.70-8.69; P = .001) independently predicted SCI. Thirty-two patients (5%) died in the perioperative period. Preoperative chronic renal failure (OR, 7.81; 95% CI, 7.81-26.31; P = .001), postoperative bowel ischemia (OR, 26.97; 95% CI, 3.37-215.5; P = .002), cardiac complications (OR, 5.77; 95% CI, 1.41-23.64; P ≤ .001), cerebrovascular complications (OR, 28.63; 95% CI, 5.20-157.5; P < .001), and SCI (OR, 5.99; 95% CI, 1.12-32.5; P = .036) were independently correlated with 30-day/in-hospital mortality. The mean follow-up was 25 ± 7 months. Freedom from target visceral vessels occlusion and freedom from reintervention were 96% and 92% at 1 year and 93% and 85% at 3 years, respectively. TAAAs (hazard ratio [HR]. 3.16; 95% CI, 1.68-5.92; P ≤ .001), postdissection TAAAs (HR, 2.20; 95% CI, 1.30-4.90; P = .05) and postoperative bowel ischemia (HR, 11.98; 95% CI, 1.53-93.31; P = .018) were independent predictors of reinterventions. Survival was 88% and 78% at 1 and 3 years, respectively. Preoperative chronic renal failure (HR, 2.39; 95% CI, 1.59-3.59; P ≤ .001), urgent repair (HR, 1.80; 95% CI, 1.03-3.20; P = .039), TAAAs (HR, 2.01; 95% CI, 1.13-3.56; P = .017), postoperative bowel ischemia (HR, 5.55; 95% CI, 2.11-14.59; P = .001), cardiac complications (HR, 3.89; 95% CI, 2.25-6.71; P ≤ .001), and pulmonary complications (HR, 1.97; 95% CI, 1.56-3.35; P = .013) were independent predictors of mortality during follow-up. ConclusionsF/B-EVAR is associated with satisfactory midterm outcomes in a nationwide experience. A variety of risk factors should be considered in F/B-EVAR indications and postoperative patient management to decrease the risk of postoperative complications and improve midterm outcomes.

Preliminary results from a multicenter Italian registry on the use of a new branched device for the treatment of thoracoabdominal aortic aneurysms

ObjectiveThe study purpose was to present early outcomes of patients treated for thoracoabdominal aortic aneurysms or complex abdominal aortic diseases using endovascular repair with a new branched endograft. MethodsThis multicenter, retrospective, observational cohort study included all patients treated with a new branched endograft. All elective patients were treated with a staged operative strategy and spinal drainage Primary outcomes of interest were technical success, early (≤30 days) mortality, and late (≥30 days) survival, and freedom from adverse aortic events. ResultsA total of 16 consecutive patients were treated for Crawford's extent type I (n = 1), type II (n = 7), type III (n = 1), and type IV (n = 5) endoleaks, with an additional two complex pararenal abdominal aortic lesions (enlarging type Ia endoleak, n = 1; anastomotic pseudoaneurysm, n = 1). There were 13 male (81%) and 3 female (19%) patients with a median age of 72.5 years (interquartile range [IQR], 69-78 years). The median diameter of the aortic aneurysm was 65 mm (IQR, 58-81 mm) and the median EuroSCORE prediction for mortality was 18% (IQR, 12%-36%). Thoracoabdominal aortic aneurysm was secondary to a previous dissection in four patients. A total of 62 of the 64 visceral vessels (96.9%) were stented. Technical success was achieved in 14 (87.5 %) and the cumulative aorta-related mortality rate was 19%. Spinal cord ischemia did not occur. The mean follow-up was 8 ± 4 months (range, 2-15 months). No type I or type III endoleaks were detected. Primary bridging stent patency was 98% (one asymptomatic thrombotic occlusion of a celiac trunk branch). No aortic reintervention was required. ConclusionsEndovascular repair of complex aortic aneurysms with this new branched endograft can be performed with high technical success and acceptable morbidity. A 19% mortality is quite high; however, it is tolerable in such a high-risk cohort. The survival rate was acceptable, and graft-related outcomes at early follow-up included an absence of threatening endoleaks and a high target visceral vessel patency.

Proximal Aortic Coverage and Clinical Results of the Endovascular Repair of Juxta-/Para-renal and Type IV Thoracoabdominal Aneurysm with Custom-made Fenestrated Endografts

Juxta-renal (JAAA)/para-renal (PAAA) and type IV-thoracoabdominal (TAAA) aneurysms can be repaired by custom-made fenestrated endografts (CM-FEVAR). Differently from open repair, a relatively long segment of healthy proximal aorta needs to be covered to achieve a durable sealing, and this may be considered a disadvantage of the endovascular approach. We aimed to quantify the additional proximal aortic coverage in JAAAs, PAAAs, and type-IV TAAAs treated with CM-FEVAR and to evaluate its impact on early/follow-up clinical outcomes. Between 2006 and 2018, preoperative, intraoperative, and postoperative data of JAAAs, PAAAs, and type-IV TAAAs submitted to CM-FEVAR were collected. The length of proximal healthy aortic coverage was evaluated on the preoperative endograft planning as the distance between the top of the CM-FEVAR endograft and the hypothetical level of aortic cross-clamping in case of open repair (type-IV TAAA-above the celiac trunk; PAAA-above the superior mesenteric artery; JAAA-above the lowest renal artery). Spinal cord ischemia (SCI), bowel ischemia (BI), renal function worsening (RFW) (estimated glomerular filtration rate reduction>25% of the baseline level - RFW), and mortality were assessed at 30-day. Survival, target visceral vessel (TVV) patency, and freedom from reinterventions (FFRs) were assessed during follow-up by Kaplan-Meier analysis R2. One hundred forty-seven cases were submitted to CM-FEVAR, for 72 (49%) JAAAs, 46 (31%) PAAAs, and 29 (20%) type IV-TAAAs, with 1(4-3%), 2 (28-19%), 3 (48-33%), and 4 (67-45%) fenestrations. JAAAs required a fenestration+bridging stent graft for the superior mesenteric artery and celiac trunk, in 46(64%) and 24(33%) cases, respectively. Nineteen (41%) PAAAs required a fenestration+bridging stent graft for the celiac trunk. The mean proximal additional aortic coverage was 48 ± 2mm with no differences among JAAAs (52 ± 1mm), PAAAs (42 ± 2mm), and type IV-TAAAs (50 ± 2mm) (P.09). Technical success, defined as correct endograft deployment, with TVV patency, absence of type I-III endoleaks, iliac leg stenosis/occlusions, open surgical conversion, and 24-hour mortality, was achieved in 98% of cases. Failures occurred for 1 type-III endoleak (type-IV TAAA) and 2 renal artery losses (PAAA and type IV-TAAA). The only case of SCI (0.7%) occurred in a type-IV TAAA where the proximal healthy aortic coverage was 80mm. One BI was caused by acute thrombosis of the bridging stent graft for the superior mesenteric artery at 24hours in 1 type IV-TAAA (0.7%). Thirty-five patients (24%) suffered postoperative RFW and required hemodialysis in 1 (0.7%) JAAA with severe preoperative chronic renal failure. There was no difference of proximal additional aortic coverage between patients with (49±29mm) and without (48±23mm) RFW (P.2). The 30-day mortality was 1.4%. The mean follow-up was 37 ± 2months with no cases of aneurysm-related late mortality. Survival was 94%, 89%, and 75% at 1, 2, and 5years, respectively. TVV patency was 97%, 97%, and 93% at 1, 2, and 5years, respectively. FFR was 98%, 95%, and 87% at 1, 2, and 5years, respectively. Custom-made FEVAR requires a mean proximal additional aortic coverage of 48 ± 2mm above the level of hypothetical aortic cross-clamping in case of open repair. This aspect should be considered for CM-FEVAR indication in JAAAs, PAAAs, and type-IV TAAAs; nevertheless, it does not appear to be associated with negative early and follow-up clinical sequelae.

Fenestrated and Branched Thoraco-abdominal Endografting after Previous Open Abdominal Aortic Repair

Proximal para-anastomotic aneurysms, or aneurysmal degeneration of the native aorta above a previous open abdominal aortic repair (Pr-AAAs), are challenging scenarios. The aim of this study was to report the early and mid term outcomes of endovascular repair of Pr-AAAs by fenestrated and branched endovascular aneurysm repair (FB-EVAR). From 2006 to 2017, pre-operative, intra-operative, and post-operative data from patients undergoing FB-EVAR for Pr-AAAs at two European vascular surgery units were prospectively collected and retrospectively analysed. Early results were considered in terms of technical success (target visceral vessel cannulation and stenting, absence of type I - III endoleak, iliac limb occlusion and 24h mortality); spinal cord ischaemia (SCI) and 30 day and in hospital mortality. Survival, target visceral vessel (TVV) patency, and freedom from re-interventions were also considered at the mid term follow up. Five hundred and forty-four patients underwent FB-EVAR to treat juxta/pararenal or thoraco-abdominal aneurysms. Of these patients, 108 (19.8%) cases were Pr-AAAs (94% male; mean±standard deviation [SD] age 71±4 years; American Society of Anesthesiologists' grade 3-4 in 74% and 26%, respectively). The previous open aortic repair (OR) was performed 10±2 years before FB-EVAR. It was a tubular aorto-aortic repair in 63 (58.3%) cases, a bifurcated aortobi-iliac repair in 37 (34.2%) cases, and an aortobifemoral bypass repair in eight (7.4%) cases. A previous thoracic endovascular aneurysm repair (TEVAR) had been performed in seven patients (6.5%). The aortic lesion at the time of FB-EVAR was, according to the Crawford classification, a type I - III in 69 (63.9%) or a type IV 39 (36.1%) thoraco-abdominal aneurysm. The mean±SD aneurysm diameter was 64±6mm. Overall, 390 TVVs (3.6±1 TVV/case) were revascularised by an endograft with fenestrations (n=63 [58.3%]), with branches (n=26 [24.1%]), or with both fenestrations and branches (n=19 [17.6%]). Tubular, trimodular, or aorto-uni-iliac implants were planned in 68 (63.0%), 38 (35.2%), and two (1.8%) patients, respectively. Proximal TEVAR, carotid-subclavian bypass, and iliac branch devices were planned as adjunctive procedures in 41 (38.0%), five (4.6%), and three (2.8%) cases, respectively. Overall technical success was 93%, with technical failures including five TVV losses (coeliac trunk, n=1; renal arteries, n=4) and three deaths within 24h. Post-operative SCI occurred in seven patients (6.5%), four of which (3.7%) were permanent. SCI was more frequent in category I - III TAAAs (p=.042) and in endografts incorporating both fenestrations and branches (p=.023). Cardiac, pulmonary, and renal complications (reduction in glomerular filtration rate of ≥30% compared with baseline) occurred in 9%, 10%, and 20%, respectively. Bowel ischaemia was seen in three (2.8%) patients. Thirty day mortality was 4% and was associated with pre-operative chronic renal failure (p=.034), post-operative cardiac morbidity (p=.041), and bowel ischaemia (p=.003). Overall in hospital mortality was 5.5% (n=6). Mean±SD follow up was 38±18 months. Survival was 82%, 64%, and 54% at one, three, and five years, respectively, and target visceral vessel patency was 93%, 91%, and 91%, respectively. Permanent haemodialysis was needed in four patients (3.7%). There was no late aneurysm related mortality. Survival during follow up was statistically significantly affected by pre-operative chronic renal failure (p=.022), post-operative cardiac morbidity (p=.042), SCI (p=.044), and bowel ischaemia (p=.003). Freedom from re-intervention at one, three, and five years was 89%, 77%, and 74%, respectively. Endovascular treatment of aneurysmal aortic degeneration above a previous open abdominal repair with FB-EVAR is safe and effective. If those promising results are confirmed at later follow up, FB-EVAR should be considered a prominent therapeutic option, especially in high risk patients.

The benefit of combined carbon dioxide automated angiography and fusion imaging in preserving perioperative renal function in fenestrated endografting

BackgroundContrast-induced nephropathy is a possible adverse event in fenestrated endovascular aneurysm repair (FEVAR). Automated carbon dioxide (CO2) angiography has been proposed as an alternative to iodinated contrast medium (ICM) for standard endovascular aneurysm repair; however, its use in FEVAR has not yet been investigated. The aim of this study was to analyze the possibility of reducing the amount of procedural ICM during FEVAR by combining CO2 with intraprocedural three-dimensional preoperative computed tomography angiography images overlaid on two-dimensional live fluoroscopy images (fusion imaging [FI]). MethodsBetween January and April 2018, juxtarenal and pararenal abdominal aortic aneurysms and type IV thoracoabdominal aortic aneurysms undergoing FEVAR with a CO2 + FI protocol were prospectively collected and compared with FEVAR cases treated with standard procedural imaging (ICM + FI) between June and December 2017. Preoperative, intraoperative, and postoperative data were analyzed. Amount of ICM, procedure and fluoroscopy time, total radiation dose (dose-area product), endoleaks, and technical success (defined as absence of type I or type III endoleak and target visceral vessel patency at completion angiography) were assessed. The 30-day renal function worsening (estimated glomerular filtration rate reduction >25% of the preoperative value) and 6-month reinterventions were also considered. Analysis was done by Fisher exact and Mann-Whitney tests. ResultsForty-five patients were enrolled, 15 (33%) managed by CO2 + FI and 30 (67%) by ICM + FI. The two groups were homogeneous in their clinical, anatomic, and endograft features. Median ICM administration was significantly lower in CO2 + FI compared with ICM + FI (41 mL [interquartile range (IQR), 26 mL] vs 138.5 mL [IQR, 88 mL]; P = .001). There was no difference in median procedure time, fluoroscopy time, and dose-area product between CO2 + FI and ICM + FI. Intraoperative type I or type III endoleak detection was similar (P = 1) in CO2 + FI (7%) and ICM + FI (7%), with immediate repair and technical success achieved in all cases. Early type II endoleak did not differ in the two groups (CO2 + FI, 27%; ICM + FI, 20%; P = .7). Postoperative renal function deteriorated in two patients (13%) in the CO2 + FI group vs eight patients (27%) in the ICM + FI group (P = .04). The median increase of postoperative creatinine concentration was smaller in the CO2 + FI group than in the ICM + FI group (0.09 mg/dL [IQR, 0.03 mg/dL] vs 0.3 mg/dL [IQR, 0.4 mg/dL]; P = .04). The median hospitalization time was shorter in the CO2 + FI group (5 days [IQR, 1 day] vs 8 days [IQR, 4 days]; P = .002). No reintervention was necessary at 30-day and 6-month follow-up in either group. ConclusionsCO2 + FI is safe and effective in FEVAR and allows the amount of ICM to be significantly reduced, leading to shorter hospitalization time and better renal function preservation at 30 days. Technical success, procedure and fluoroscopy time, radiation dose, and 6-month reinterventions are comparable with those of the standard ICM imaging protocol for FEVAR. Based on this preliminary experience, CO2 + FI may be proposed as an effective tool to reduce the overall amount of procedural ICM, with consequent benefits on perioperative renal function.

Steerable Sheath for Cannulation and Bridging Stenting of Challenging Target Visceral Vessels in Fenestrated and Branched Endografting

To report the use of the Oscor Destino steerable sheath in challenging target visceral vessel (TVV) cannulation/bridging stenting in fenestrated and branched endovascular aneurysm repair (FB-EVAR). Between 2016 and 2018, patients undergoing FB-EVAR for juxtarenal/pararenal aneurysms (j/p-AAAs) and thoracoabdominal aortic aneurysms (TAAAs) were recorded. Cases requiring the use of the steerable sheath as planned or unplanned maneuvers were analyzed. Technical success, freedom from reinterventions, and TVV patency were assessed. Two hundred sixty patients underwent FB-EVAR to treat j/p-AAAs and TAAAs, for an overall of 956 TVVs. Among these, the Oscor Destino steerable sheath was used in 33 (13%) cases to cannulate a total of 62 (7%) TVVs. FB-EVAR was performed for 7 (21%) j-AAAs, 4 (12%) p-AAAs, 11 (61%) TAAAs, and 2 (6%) previously failed EVAR. The TVVs were 37 (60%) renal arteries, 9 (15%) superior mesenteric arteries, and 16 (25%) celiac trunks. The Oscor Destino steerable sheath was used as the primary cannulation approach in 29 (47%) cases and after failure of the standard cannulation technique in 33 (53%) cases. Technical success was achieved in 61/62 (98%) TVVs. There was no 30-day mortality or bowel ischemia. At the discharge, there were no type I/III endoleaks, whereas 4 type II endoleaks were detected. The median follow-up was 12months (interquartile range: 8). One patient died at 6 months because of aneurysm-unrelated cause. No TVV occlusion or TVV-related reinterventions occurred. There were no type I-III endoleaks. The use of the steerable sheath could be an effective adjunctive tool and can be used primarily as a planned technique or in case of failure of the standard cannulation technique in challenging TVV anatomy during FB-EVAR.

The Italian Multi-centre Experience of Fenestrated Anacondatm Endograft for Juxta/Para-renal Aortic Aneurysms

Introduction - Aim of this study is to describe the outcomes of “AnacondaTM-Fenestrated Endograft (Vascutek, Inchinnan, UK) Italian registry” for challenging abdominal aortic aneurysms (AAA), unfit for standard endovascular aortic repair (EVAR). Methods - Between 2012 and 2017, patients with proximal neck unsuitable for standard EVAR were prospectively enrolled. Clinical (demographic, cardiovascular risk factors, co-morbidities) and morphological aortic-iliac features were collected. Intra and peri-operative data were analyzed. Early endpoints were technical success (TS defined as absence of endoleaks (EL) I-III, patency of target visceral vessels (TVV) and iliac legs and 24-hour survival). Late endpoints were survival, endoleaks, TVV patency and limb occlusion/stenosis, freedom from re-interventions and AAA-related mortality during the follow-up. Results - Seventy-eight patients (male 92%(62); mean age 74±4 years, ASA III-IV:73-27%) were submitted to Fenestrated-AnacondaTM in 25 Italian Vascular Surgery Units (73 juxta/para-renal AAA, 4 Type IV TAAA and 1 EL 1A post-EVAR). The mean AAA diameter was 58mm ± 3mm (range: 50-70mm). Configuration with 1, 2, 3 and 4 fenestrations were used in 3 (4%), 40 (51%), 25 (32%) and 10 (13%) cases, respectively for a total of 198 visceral vessels, (3.6±1TVV/patient). Sixty-six (85%) bifurcated and 12 (15%) tube endograft were implanted. The endograft was repositioned during the procedure in 42% (33/78) of cases. From the brachial access, at least 1 TVV was cannulated in 54% (27/52) of cases. TS was 90% (70/78) due to 5 type I EL, 1 type III EL (between fenestration and vessel stent) and 2 renal artery occlusions. All the target visceral vessels were cannulated and stented. The 30-day mortality was 5.1% (4/78). One patient died for a multiple organ disfunction syndrome (MOF) after renal artery ligature ad nephrectomy; one patient died for sepsis after embolization of the renal artery for artery perforation, two patients died for cardiological reasons. Two of the 5 type I EL solved spontaneously at 30-day for adaptation of the sealing ring of the device to the aortic neck. Two type III endoleak detected at the completion angiography were treated by relining of renal artery. At a median follow-up of 20 months (range:1-60) there were 3 type I EL, 2 type III EL and 3 occlusions of renal artery. The reintervention free-survival was 91% and no AAA-related mortality occurred. One patients had a bilateral renal artery occlusion so he has subjected to thrombolysis combined with angioplasty. A patient with type II EL underwent to open hypogastric ligature and another to lumbar embolization. There was an aortic rupture due to a proximal progression of AAA in a patient with two fenestrations for renal arteries; the patient was treated by suprarenal extension with chimney technique for celiac trunk and upper mesenteric artery. The survivor at 36 months was 77% (no AAA-related mortality hasn’t been reported). Conclusion - AnacondaTM-Fenestrated Endograft is an effective treatment of challenging AAA. The repositionability, the brachial access and the adaptation during the follow-up of the proximal ring are useful for complex anatomies and increase the technical success of the procedure.

Outcomes After Fenestrated and Branched Endografts for Juxtarenal, Pararenal, and Thoraco-abdominal Aortic Aneurysm Repair: 1-year Follow-up

Introduction: The aim of this study was to evaluate the 1-year follow-up results of fenestrated (FEVAR) and branched (BEVAR) endovascular aortic repair in terms of mortality, target visceral vessel patency, endoleaks, and reintervention rates. Methods: All consecutive patients treated with FEVAR or BEVAR in a single center were included in a prospectively maintained database. Analyses of outcomes included technical success, operative mortality and late events with regard to target vessel stent patency, reintervention, endoleak, and mortality during follow-up. Survival, target vessel stent patency, and reinterventions during follow up were subjected to Kaplan-Meier analysis. Results: A total of 38 patients were treated for juxta/pararenal abdominal aortic aneurysm (n=23), thoraco-abdominal aneurysm (n=12) or type I endoleak (n=3). 24 FEVAR (22 Terumo Aortic Fenestrated Anaconda endografts, 2 JOTEC E-xtra Design Engineering) and 15 BEVAR (inner or outer branched JOTEC E-xtra Design Engineering) procedures were performed from 2013 to December 2018. 97.4% of patients were male, mean age was 72.3 (±7.3) years and mean aortic diameter was 69.4 (±16.6) mm. 6 patients had previously undergone at least one open/endovascular aortic procedure. Technical success (stent graft implantation with patent stented target vessels and no Type I/III endoleak) was 97.4%. Revascularization was successful in 129 of 131 target vessels (97.7%). In two patients catheterization/stenting of one renal artery was not possible. Survival at 30 days was 86.8%. 4 patients died within 30 days. Mean follow-up was 15.1 (±17.2) months. Survival at 1 year was 67.5%. During follow up,10 patients died, one of them aneurysm-related. Freedom from endoleak at 1 year was 70.7%; 5 type I endoleaks treated and 2 type II endoleaks in follow-up. Freedom from reintervention at 1 year was 67.5%; 5 type 1 endoleaks (2 type Ia, 3 type Ib), 1 dissection, 3 access vessel complications (1 external iliac thrombosis, 2 common femoral artery stenosis/thrombosis). Freedom from target vessel thrombosis at 1 year was 93.1%. Conclusion: Total endovascular repair in juxta/pararenal abdominal aortic aneurysm and thoracoabdominal aneurysms has favorable midterm results. Most of the reinterventions were performed on renal arteries endoleaks or on vessel access complications. Disclosure: Nothing to disclose

Impact of previous open aortic repair on the outcome of thoracoabdominal fenestrated and branched endografts

BackgroundThoracoabdominal aortic aneurysms (TAAAs) after previous aortic open surgical repair (OSR) are challenging clinical scenarios. Redo-OSR is technically demanding, and standard endovascular repair is unavailable due to visceral vessel involvement. Fenestrated and branched endografts (FB-EVAR) are effective options to treat TAAAs in high surgical risk patients but dedicated studies on the FB-EVAR outcomes in patients with TAAAs with previous OSR are not available. The aim of the study was to evaluate the impact of previous OSR on TAAAs FB-EVAR outcomes. MethodsBetween 2010 and 2016, all TAAAs undergoing FB-EVAR were prospectively evaluated, retrospectively categorized in two groups, and then compared: group A–primary TAAAs and group B–TAAAs after previous OSR (abdominal, thoracic, or thoracoabdominal aneurysm). Early end points were technical success (absence of type I-III endoleak, target visceral vessel loss, conversion to OSR, intraoperative mortality), spinal cord ischemia (SCI), and 30-day mortality. Follow-up end points were survival, target visceral vessel patency, and freedom from reinterventions. ResultsSixty-two patients (male: 74%; age: 72 ± 7 years) with 1 (1%) extent I, 14 (23%) extent II, 24 (39%) extent III, and 23 (37%) extent IV TAAA underwent FB-EVAR. The mean TAAA diameter and total target visceral vessels were 65 ± 13 mm and 226, respectively. Ninety branches and 136 fenestrations were planned. Thirty cases (48%) were clustered in group A and 32 (52%) in group B. Patients in group A and group B had similar preoperative clinical and morphologic characteristics, except for female sex (group A: 40% vs group B: 13%; P = .02). Technical success was 92% (group A: 90% vs group B: 94%; P = .6), SCI 5% (group A: 10% vs group B: 0%; P = .1) and 30-day mortality 5% (group A: 10% vs group B: 0%; P = .1). The mean follow-up was 17 ± 11 months with a total survival of 86%, 80%, and 60% at 6, 12, and 24 months, respectively and no differences in the two groups (group A: 83%, 83%, and 67% vs group B: 88%, 78%, and 55% respectively; P = .96). There was no late TAAA-related mortality. Target visceral vessel patency was 91%, 91%, and 91% at 6, 12, and 24 months, respectively (group A: 87%, 87%, and 87% vs group B: 95%, 95%, and 95%; P = .25). Freedom from reinterventions was 90%, 87%, and 87%, at 6, 12, and 24 months, respectively, and it was significantly lower in group A compared with group B (group A: 83%, 76%, and 76% vs group B: 96%, 96%, and 96% respectively; P = .002). ConclusionsPrevious open surgery repair does not significantly affect the early outcomes of FB-EVAR in TAAA, with encouraging results in terms of technical success, SCI, mortality, and lower reinterventions rate at midterm follow-up.

Durability of fenestrated endovascular aortic repair for juxta-renal abdominal aortic aneurysm repair.

The aim of this study was to evaluate the long term durability of fenestrated endovascular aortic aneurysm repair (F-EVAR) of juxta-renal aortic aneurysms (JAAAs) in terms of mortality, target visceral vessel (TVV) patency and Reintervention rates. A systematic review and meta-analysis was performed. MEDLINE, CENTRAL, and Cochrane databases were searched with PRISMA methodology for studies reporting on F-EVAR of JAAA presenting follow-up >36 months. Articles with <15 patients, follow-up <36 months, comparison of F-EVAR with other treatment modalities were excluded. Seven non-randomized retrospective studies of prospectively collected data were analysed including 772 patients (mean age and diameter ranging from 71.5 to 74 years and from 60 to 65mm, respectively) underwent F-EVAR for JAAA during 2001-2015. The pooled mortality rates during 12, 24, 36, 48 and 60 months were 0.080 (0.060-0.106), 0.129 (0.097-0.169), 0.211 (0.158-0.277), 0.279 (0.193-0.386) and 0.405 (0.303-0.517), respectively. The pooled Reintervention rates during 12, 24, 36 and 48 months were 0.097 (0.066-0.140), 0.131 (0.082-0.203), 0.281 (0.182-0.406) and 0.244 (0.103-0.477), respectively. The pooled loss of TVV patency rates during 12, 24, 36, 48 and 60 months were 0.046 (0.035-0.060), 0.081 (0.058-0.110), 0.088 (0.060-0.127), 0.123 (0.067-0.214) and 0.132 (0.081-0.207). F-EVAR for the treatment of patients with JAAA is a durable procedure with good long term outcomes in terms of mortality and visceral vessels patency. During long term period the need for a Reintervention continues to exists, thus follow-up of those cases may be important for preserving the good results.

Endovascular Repair of Thoracoabdominal Aortic Aneurysm in High-Surgical Risk Patients: Fenestrated and Branched Endografts

To report early and mid-term results of endovascular repair of thoracoabdominal aortic aneurysms (TAAAs) by using Cook Zenith fenestrated/branched endografts (FB-EVAR) in high surgical risk patients unfit for open repair (OR). Between January 2012 and April 2015, all the patients with TAAA, considered at high surgical risk for OR and treated by Cook Zenith FB-EVAR, were prospectively enrolled. Patients were studied using a thoracoabdominal computer tomography angiography (CTA) and dedicated software for advanced vessels analysis. Follow-up was performed by duplex ultrasound (DU), contrast-enhanced DU, and/or CTA. Early end points were the following: technical success (TS), spinal cord ischemia (SCI), and 30-day morbidity/mortality. Follow-up end points were the following: survival, TAAA-related mortality, target visceral vessels (TVV) patency, type I/III endoleaks, and freedom from reinterventions (FFRs). Thirty patients (male 77%, mean age 73±7years, American Society of Anesthesiologists 3/4 60%/40%) affected by TAAA type I (4%), II (21%), III (57%), and IV (18%) were enrolled. The mean aneurysm diameter was 66±14mm. The overall number of TVV was 107 (3.5±0.9 vessels/patients). Custom-made and off-the-shelf endografts were used in 22 (73%) and 8 (23%) cases, respectively. The procedure was performed in multiple steps in 23 cases (77%). There were not intraoperative mortality and type I-III endoleaks, and the TVV patency was 97% (104/107). TS was 87%.There were 2 irreversible paraplegias (6.6%) and 1 reversible paraparesis (3.4%). Postoperative cardiac and pulmonary complications occurred in 2 (6.6%) and 2 (6.6%) patients, respectively. Renal function worsening (≥30% of the baseline level) was detected in 4 cases (13%). The 30-day mortality was 6.6%. Survival at 6, 12, and 24months was 90%, 85%, and 68%, respectively. There was no TAAA-related mortality. The TVV patency at 3, 6, and 24months was 95%, 90%, and 90%, respectively, and there were no type I-III endoleaks. FFRs at 6, 12, and 24months was 88%. The endovascular repair of TAAA by using Cook Zenith fenestrated/branched endografts is feasible with acceptable technical and clinical results at early to mid-term results in patients at high surgical risk unfit for OR.

The endovascular treatment of juxta-renal abdominal aortic aneurysm using fenestrated endograft: early and mid-term results.

The aim of the present study was to evaluate the early and mid-term results of the endovascular treatment of juxta-renal abdominal aortic aneurysms (j-AAA) using fenestrated endograft (FEVAR). Between 2008 to 2013 all consecutive patients underwent FEVAR using Cook-Zenith fenestrated endograft for treating j-AAA (proximal neck length <5 mm) with renal aortic α/β angle <60°, were prospectively collected in a database. Cardiovascular risk factors, comorbidities, aortic-iliac morphological features, intra and post-procedural data were analyzed. Preoperative FEVAR planning was performed by a thoraco-abdominal computer tomography angiography (CTA) and the 3D/Center Lumen Line reconstructions (3mensio Medical Imaging, Bilthoven, The Netherlands). Follow-up was conducted by duplex ultrasound (DUS)/ contrast enhancement DUS (CEUS) and/or CTA at 1, 6, and 12 months, and yearly thereafter. Early endpoints were technical (TS) and clinical success (CS), renal function worsening (≥30% of preoperative creatinine value) and type I/III endoleak. Mid-term endpoints were: type I/III endoleak, target visceral vessels patency, j-AAA shrinkage, freedom from reintervention and survival. Twenty patients (94.7% of whom male; mean age: 73.4±5.9 years; ASA≥3: 100%) were enrolled. The mean neck length and j-AAA diameter were 2±1.4 mm (range: 0-4 mm) and 54.9±5 mm, respectively. Eleven (55%) endograft with two fenestrations and a scallop, 8 (45%) with three fenestrations and a scallop, and one (5%) with one fenestration and a scallop were implanted. Sixty-seven visceral vessels were re-vascularized. TS and CS were 100% and 95%, respectively (1/20 30-day mortality). Perioperative renal function worsening was observed in 15% of cases. The mean follow-up was 25±20 months (range: 2-72 months). No type I/III endoleak or occlusion of target visceral vessels occurred. There was j-AAA shrinkage in 65% of patients and no cases of j-AAA enlargement were observed. There were no FEVAR-related reinterventions. Survival at 12, 24, and 36 months were 89.4%, 80.5%, and 80.5%, respectively. According to our results, the endovascular treatment for j-AAA, with α/β angle <60°, is safe and effective.

In Brief

To report early and mid-term results of endovascular repair of thoracoabdominal aortic aneurysms (TAAAs) by using Cook Zenith fenestrated/branched endografts (FB-EVAR) in high surgical risk patients unfit for open repair (OR).Between January 2012 and April 2015, all the patients with TAAA, considered at high surgical risk for OR and treated by Cook Zenith FB-EVAR, were prospectively enrolled. Patients were studied using a thoracoabdominal computer tomography angiography (CTA) and dedicated software for advanced vessels analysis. Follow-up was performed by duplex ultrasound (DU), contrast-enhanced DU, and/or CTA. Early end points were the following: technical success (TS), spinal cord ischemia (SCI), and 30-day morbidity/mortality. Follow-up end points were the following: survival, TAAA-related mortality, target visceral vessels (TVV) patency, type I/III endoleaks, and freedom from reinterventions (FFRs).Thirty patients (male 77%, mean age 73 ± 7 years, American Society of Anesthesiologists 3/4 60%/40%) affected by TAAA type I (4%), II (21%), III (57%), and IV (18%) were enrolled. The mean aneurysm diameter was 66 ± 14 mm. The overall number of TVV was 107 (3.5 ± 0.9 vessels/patients). Custom-made and off-the-shelf endografts were used in 22 (73%) and 8 (23%) cases, respectively. The procedure was performed in multiple steps in 23 cases (77%). There were not intraoperative mortality and type I–III endoleaks, and the TVV patency was 97% (104/107). TS was 87%.There were 2 irreversible paraplegias (6.6%) and 1 reversible paraparesis (3.4%). Postoperative cardiac and pulmonary complications occurred in 2 (6.6%) and 2 (6.6%) patients, respectively. Renal function worsening (≥30% of the baseline level) was detected in 4 cases (13%). The 30-day mortality was 6.6%. Survival at 6, 12, and 24 months was 90%, 85%, and 68%, respectively. There was no TAAA-related mortality. The TVV patency at 3, 6, and 24 months was 95%, 90%, and 90%, respectively, and there were no type I–III endoleaks. FFRs at 6, 12, and 24 months was 88%.The endovascular repair of TAAA by using Cook Zenith fenestrated/branched endografts is feasible with acceptable technical and clinical results at early to mid-term results in patients at high surgical risk unfit for OR.