Pre-emptive False Lumen Embolization to Prevent Persistent Type II Endoleak in Fenestrated-Branched Endovascular Repair of Post-Dissection Thoracoabdominal Aortic Aneurysms.

PURPOSE: The purpose was to describe a technique to promote false lumen (FL) thrombosis in post-dissection thoracoabdominal aortic aneurysms (PD-TAAAs) managed by fenestrated/branched endografting (F/B-EVAR). TECHNIQUE: A 5/6Fr-90 cm length sheath is advanced from the true lumen (TL) to FL through the most distal entry tear of the infrarenal aorta or iliac arteries. It is parked in the most cranial portion of the FL in the thoracic aorta. Aortic endografts are deployed in the TL excluding all the para-visceral/distal entry tears and target visceral vessels bridging stenting is performed. A selective FL angiography is performed through the 5/6Fr sheath to detect the origin of all segmentary arteries. Embolization of FL is performed from above to below by M-reye pushable coils, obtaining the packaging of FL. After completion angiography, the 5/6Fr sheath is retrieved in external iliac artery and molding ballooning of the distal segment of the aortic/iliac endograft is performed. Between 2019 and 2023, this technique was applied in 11cases with a median number of 73 (interquartile range [IQR=12) coils. Out of 8 (72%) patients with available radiological follow-up at 1 year, 7 exhibited complete FL thrombosis. CONCLUSIONS: The FL coiling in PD-TAAAs managed by F/B-EVAR is feasible, safe, and effective to promote the complete FL thrombosis. CLINICAL IMPACT: Preemptive false lumen embolization is a feasible, safe, and effective technique for preventing persistent type II endoleaks after fenestrated-branched endovascular repair of post-dissection thoracoabdominal aortic aneurysms. This technique may be routinely recommended to promote FL thrombosis and aortic remodeling after FB-EVAR in PD-TAAAs, thereby reducing the incidence of reinterventions during follow-up.

European Multicentric Experience With Fenestrated-branched ENDOvascular Stent Grafting After Previous FAILed Infrarenal Aortic Repair: The EU-FBENDO-FAIL Registry.

OBJECTIVE: To report the mid-term outcomes of fenestrated-branched endovascular aneurysm repair (F-BEVAR) following a failed previous endovascular aneurysm repair (pEVAR) or previous open aneurysm repair (pOAR). METHODS: Data from consecutive patients who underwent F-BEVAR for pEVAR or pOAR from 2006 to 2021 from 17 European vascular centers were analyzed. Endpoints included technical success, major adverse events, 30-day mortality, and 5-year estimates of survival, target vessel primary patency, freedom from reinterventions, type I/III endoleaks, and sac growth >5 mm. BACKGROUND: Treatment of a failed previous abdominal aortic aneurysm repair is a complex undertaking. F-BEVAR is becoming an increasingly attractive option, although comparative data are limited regarding associated risk factors, indications for treatment, and various outcomes. RESULTS: There were 526 patients included, 268 pOAR and 258 pEVAR. The median time from previous repair to F-BEVAR was 7 (interquartile range, 4-12) years, 5 (3-8) for pEVAR, and 10 (6-14) for pOAR, P <0.001. Predominant indication for treatment was type Ia endoleak for pEVAR and progression of the disease for pOAR. Technical success was 92.8%, pOAR (92.2%), and pEVAR (93.4%), P =0.58. The 30-day mortality was 6.5% overall, 6.7% for pOAR, and 6.2% for pEVAR, P =0.81. There were 1853 treated target vessels with 5-year estimates of primary patency of 94.4%, pEVAR (95.2%), and pOAR (94.4%), P =0.03. Five-year estimates for freedom from type I/III endoleaks were similar between groups; freedom from reintervention was lower for pEVAR (38.3%) than for pOAR (56.0%), P =0.004. The most common indication for reinterventions was for type I/III endoleaks (37.5%). CONCLUSIONS: Repair of a failed pEVAR or pOARis safe and feasible with comparable technical success and survival rates. While successful treatment can be achieved, significant rates of reintervention should be anticipated, particularly for issues related to instability of target vessels/bridging stents.

Midterm results of complicated penetrating abdominal aortic ulcer treated by aortobi-iliac endograft and embolization.

BACKGROUND: Penetrating aortic ulcer (PAU) is determined by atherosclerotic degeneration of the tunica media with disruption of the intima. Usually it is detected in the thoracic aorta, with few series describing an abdominal location. The aim of the study was to report early and late outcomes of the endovascular repair of complicated infrarenal abdominal PAU (a-PAU) by aortobi-iliac endograft and embolization. METHODS: Data from all complicated a-PAU submitted to endovascular repair by aortobi-iliac endograft (Cook-Zenith Alpha) between 2016 and 2021 (February) were analyzed. The a-PAU coil embolization was performed to decrease the risk of persistent type II endoleak whenever possible. Complicated a-PAU were defined according with the presence of symptoms, aortic rupture, or saccular or pseudo-aneurysm. Technical success, 30-day morbidity and mortality, and reinterventions were assessed as early outcomes. Survival, endoleaks, and freedom from reinterventions were evaluated during follow-up. RESULTS: Of 1153 endovascular aortic procedures, 45 cases (4%) of complicated a-PAU were identified. Fourteen cases (31%) were managed in urgent setting (symptoms, n = 10 [22%]; shock, n = 4 [9%]). The median diameter of a-PAU was 49 mm (interquartile range, 14 mm). Thirteen patients (29%) had severe femoral or iliac access (angle >90°, circumferential calcification [>50%], hemodynamic iliac stenosis or obstruction, an external iliac artery diameter of less than 7 mm, or a previous femoral surgical graft). The a-PAU embolization was performed in 30 cases (67%). Technical success was achieved in all patients. Postoperative cardiac, pulmonary and renal morbidity occurred in one (2%), two (4%), and eight (18%) patients, respectively. Two patients (4%) required reintervention within 30 days for access related complications. The 30-day mortality was 2%. At a median follow-up of 24 months (interquartile range, 18 months), no type I or III endoleaks, iliac leg occlusion, or graft infection occurred and no patient required late reinterventions; the 36-month survival rate was 72%. No a-PAU enlarged or ruptured during follow-up. CONCLUSIONS: Endovascular repair of complicated a-PAU by a low-profile aortobi-iliac endograft and embolization is safe and effective. Excellent technical results are reported even in challenging anatomic features. Midterm clinical results are satisfactory in terms of aortic-related complications or mortality, freedom from reintervention, and survival.

Endovascular Treatment of Abdominal Aortic Aneurysm With Severe Angulation of Infrarenal Aortic Neck by Gore Conformable Endograft.

INTRODUCTION: The aim of the study is to report a single-center experience with the Gore Excluder conformable endograft with active control system (CEXC Device, W.L. Gore and Associates, Flagstaff, AZ, USA) in abdominal aortic aneurysms (AAAs) with severe infrarenal neck angulation. METHODS: All patients underwent EVAR with CEXC Device between September 2018 and 2020, were prospectively enrolled, and retrospectively analyzed. Anatomical details of the proximal aortic neck were evaluated. Early endpoints were the use of repositionability and angulation system, intraoperative unplanned cuff, technical success (TS), 30-day morbidity/mortality, and reintervention. Follow-up endpoints were type-I endoleaks, endograft migration, aortic neck dilatation, aneurismal sac shrinkage, survival (S), and freedom from reintervention (FFR). RESULTS: Twenty-five patients were enrolled (median age: 80 [range = 60-90] years, median AAA diameter: 60 [range = 52-90] mm). All patients had severe infrarenal neck angulation (beta angle ≧ 60°), and 11 (44%) of those had neck beta angle ≧ 90°. Median infrarenal neck angle, length, and diameter were 70° (range = 60°-90°), 22 (range = 13-42) mm and 22 (range = 18-31) mm, respectively. Endograft repositioning system was employed in 15 (60%) cases and the median number of repositioning maneuvers was 1 (range:0-4). Active angulation system was used in 17 (68%) patients. The median proximal diameter of the main-body and oversize were 28 (range = 23-36) mm and 28% (range = 21%-38%), respectively. Proximal cuff was positioned in 1 (4%) patient. Technical success was achieved in all cases. Intraoperative and perioperative morbidity and mortality were 12% and 0%, respectively. Perioperative type-I/III and II endoleaks were observed in 0 and 4 (16%) patients, respectively. The median follow-up was 12 months (range: 3-30). One patient died at 12-month for AAA-unrelated causes. Abdominal aortic aneurysm-sac shrinkage and stability were observed in 9 (36%) and 15 (60%) cases, respectively. No type-I/III endoleak and reintervention occurred during the follow-up. One persistent type-II endoleak was observed. Estimated survival at 24 months was 92%. CONCLUSION: According to the present data, the CEXC Device allows an excellent rate of TS in severe angulated aortic neck. This preliminary data, could increase the rate of patients eligible for EVAR.

Morphological and Clinical Predictors of Early/Follow-up Failure of the Endovascular Infrarenal Abdominal Aneurysm Repair With Currently Available Endografts.

PURPOSE: To report outcomes of endovascular repair (EVAR) of infrarenal abdominal aortic aneurysms (AAAs) with currently-available endografts and identify predictors of technical/clinical failure. MATERIALS AND METHODS: Patients undergoing EVAR between 2012 and 2020 were prospectively collected and retrospectively analyzed. Technical success (TS: no type I-III endoleaks, renal/hypogastric arteries loss, iliac leg occlusion, conversion to open repair and mortality within 24 postoperative hour), proximal neck-related TS (nr-TS: no proximal type I endoleaks, unplanned renal arteries coverage), and 30-day mortality were assessed as early outcomes. Proximal type I endoleak (ELIa), survival and freedom from reinterventions (FFRs) were assessed during follow-up. Uni/multivariate analysis and Cox-regression were used to identified factors associated with early and follow-up outcomes; FFR and survival were assessed by Kaplan-Meier analysis. RESULTS: A total of 710 were included. Technical success and nr-TS were 692 (98%) and 700 (99%), respectively. The presence of ≥2 hostile anatomical infrarenal neck characteristics was associated with technical failure (odds ratio [OR]: 2.4; 95% confidence interval [CI]: 1.3-4.1; p: 0.007). Infrarenal neck angle >90° (OR: 2.88; 95% CI: 9.6-50.3; p: 0.004), barrel shape (OR: 2.33; 95% CI: 11.1-100.3; p: 0.02) or presence of ≥2 hostile anatomical infrarenal neck characteristics (OR: 2.16; 95% CI: 2.5-5.3; p: 0.03) were independent risk factors for neck-related technical failures. Six (0.8%) patients died within 30 postoperative days. Chronic obstructive pulmonary disease (OR: 16; 95% CI: 1.1-218.3; p: 0.04) and urgent repair (OR: 15; 95% CI: 1.8-119.6; p: 0.01) were independent risk factors for 30-day mortality. The mean follow-up was 53±13 months. There were 12 (1.7%) ELIa during follow-up. Infrarenal neck length <15 mm (hazard ratio [HR]: 2.8; 95% CI: 1.9-9.6; p: 0.005), diameter >28 mm (HR: 2.7; 95% CI: 1.6-9.5; p: 0.006), angle ≥90° (HR: 2.7; 95% CI: 8.3-50.1; p: 0.007), and persistent type II endoleak (HR: 2.9; 95% CI: 1.6-10.1; p: 0.004) were independent risk factors for ELIa. Freedom from reintervention was 91% at 5 years. The ELIa was an independent risk factor for reinterventions during follow-up (HR: 29.5; 95% CI: 1.4-1.6; p<0.001). Survival was 74% at 5 years with 2 cases (0.3%) of late aortic-related mortality. Peripheral arterial occlusive disease (HR: 1.9; 95% CI: 1.4-3.65; p: 0.03), aneurysm diameter ≥65 mm (HR: 2.2; 95% CI: 1.4-3.26; p<0.001), and infrarenal neck length <15 mm (HR: 1.7; 95% CI: 1.2-2.35; p: 0.04) were independent risk factors for mortality during follow-up. CONCLUSION: Endovascular repair with currently-available endografts has high TS and low 30-day mortality. Survival and FFRs were satisfactory at mid-term. Pre/postoperative risk factors for technical and clinical failure were identified and they should be considered in EVAR indication and postoperative management to reduce complications and improve mid-term outcome. CLINICAL IMPACT: Pre and postoperative risk factors for technical and clinical EVAR failure can be identified and they should be considered in EVAR indication and postoperative management to reduce complications and improve mid-term outcome.

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

AIM/BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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. CLINICAL IMPACT: 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.

Anatomical feasibility of the current endovascular solutions for Juxtarenal aortic abdominal aneurysm repair.

PURPOSE: Endovascular repair of juxta-renal aneurysms (JAAAs) can be achieved by fenestrated endografts (FEVAR), parallel-grafts (CHEVAR) and standard abdominal endografts + endoanchors (ESAR). Aim of this study was to evaluate the incidence of their anatomical feasibility in JAAAs. MATERIALS AND METHODS: All patients submitted to JAAAs treatment from 2006 to 2019 were retrospectively analyzed, irrelevant of the procedure performed. Juxta-renal aneurysm was defined according with the current ESVS clinical practice guidelines. Preoperative computed tomography angiographies were analyzed to evaluate the anatomical feasibility of: FEVAR (Cook Zenith-platform; CE-marked or custom-made device), CHEVAR (Medtronic Endurant + Atrium Advanta - CE marked combination) and ESAR (Medtronic Endurant + Helifix - CE marked combination) according with the manufactures' instruction for use. The anatomical feasibility of these three endovascular solutions was assessed according with the proximal neck, target visceral vessels (TVVS) and iliac access characteristics. RESULTS: Ninety-nine cases were considered. There were no cases of frank aortic rupture and in all patients at least one arterial access from above was available. Fenestrated endograft, CHEVAR, and ESAR were anatomically feasible in 93 (94%), 37 (37%), and 27 (27%) cases, respectively (p <. 001). Fenestrated endograft requires design with <3, three and >3 fenestrations in 29 (31%), 33 (36%), and 31 (33%) cases, respectively. Parallel graft technique have required 1 or 2 parallel graft configurations in 12 (12%) and 25 (25%) cases, respectively. Among the 14 cases with aneurysm diameter >70 mm, the anatomical feasibility of FEVAR, CHEVAR, and ESAR was 13(93%), 4(29%), and 4 (29%) cases, respectively (p < .001). CONCLUSION: Fenestrated endograft is more frequently applicable than CHEVAR and ESAR as endovascular treatment of JAAAs. Since this difference is valid also in aneurysms with diameter >70 mm, the issue of a rapid availability is of paramount importance. The 6% of cases have not any endovascular solution and requires open surgery.

Multi-Staged Endovascular Repair of Thoracoabdominal Aneurysms by Fenestrated and Branched Endografts.

BACKGROUND: To report outcomes of a multi-staged approach for endovascular repair of thoracoabdominal aortic aneurysms (TAAAs) by fenestrated/branched endografting (F/B-EVAR). METHODS: Between 2010 and 2020 (June), patients undergoing F/B-EVAR for TAAAs were collected. Data of cases managed by a multi-staged approach, to reduce the incidence of spinal cord ischemia (SCI), were retrospectively analyzed and reported in a cohort study. Thirty-day mortality and SCI were assessed as study's outcomes. RESULTS: One hundred and thirty-seven patients underwent TAAAs repair by F/B-EVAR. A multi-staged approach was applied in 73(53%) cases, more frequently for Crawford's extent I-III (60/78) compared with IV (13/59) (P < 0.0001). A complete TAAAs exclusion was achieved in 2, 3 or 4 steps in 64(88%), 8(11%) and 1(1%) cases, respectively, within the same hospitalization in 68(93%) cases. The mean time between first and last step was 16 ± 8days, with a mean hospital stay of 21 ± 12days. In 3(4%) cases the complete TAAA repair was not achieved due to inter-steps mortality (2) or permanent paraplegia (1). There were no cases of aortic rupture or target visceral vessels occlusions between the different steps. Seven (10%) patients suffered postoperative SCI with 2(4%) cases of permanent paraplegia. In 5/7 cases SCI occurred after the first stage; in 3/5 cases TAAAs exclusion was successfully completed with total SCI recovery. The 30-day mortality was 4% (3/73). CONCLUSIONS: A multi-staged endovascular repair with F/B-EVAR can be safely performed for TAAAs repair. The majority of cases can be treated within a single, long hospitalization. The cost/effectiveness of the prolonged in-hospital time should be evaluated.

Platelet Depletion after Thoraco-Abdominal Aortic Aneurysm Endovascular Repair is Associated with Clinically Relevant Hemorrhagic Complications.

BACKGROUND: Thoraco-abdominal endovascular aortic repair (TA-EVAR) can be associated with platelet depletion (PD); the present study aims to evaluate PD incidence after TA-EVAR and to investigate its possible predictors and its influence on hemorrhagic complications and mortality. METHODS: A retrospective analysis of all TA-EVAR from 2010 to 2021 was performed to identify patients with PD, (reduction > 60%). Spontaneous hemorrhages considered were: intracranial or any hemorrhages requiring surgery. Risk factors for PD, correlation with hemorrhagic complications and 30-day mortality were investigated by uni/multivariate analysis. RESULTS: A total of 158 TA-EVAR were considered, 35(22%) female, 86(54%) extended thoraco-abdominal aortic aneurysm (TAAA) (Crawford type I, II, III), 79(50%) staged procedure, 31(20%) urgent treatment (symptomatic/ruptured). PD was identified in 42 (27%) patients and correlated to female sex, thrombus-free aortic lumen > 50mm, urgent treatment, extensive TAAA, blood transfusion >3 units and staged procedure at the univariate analysis. The multivariate analysis confirmed a significant correlation between PD and thrombus-free aortic lumen > 50mm, urgent treatment, blood transfusion > 3 units and staged procedure (odds ratio [OR]: 2.5 (95% confidence interval [CI] 1.03-7.0), P = 0.04, OR 3.2 (95% CI 1.01-8.6), P= 0.03, OR 3.16 (95% CI 1.23-7.7), P = 0.03 and OR 2.71 (95% CI 1.2-6.2), P= 0.04, respectively). Overall, 13 hemorrhagic complications occurred (8 intracranial and 5 peripheral); PD was associated with higher risk of hemorrhagic complications (9/42 - 21% vs. 4/116 - 3%, OR: 7.6 [95% CI: 2.2-26.3], P= 0.001) and a higher risk of 30-day mortality in elective cases 4/25 - 16% vs. 3/101 - 3%, OR: 6.2 (95% CI: 1.3-29.8), P= 0.03. CONCLUSIONS: PD is a relatively common event after TA-EVAR and is associated with thrombus-free aortic lumen > 50mm, urgent treatment, blood transfusion > 3 units and staged procedure. Hemorrhagic complications and mortality are increased under these circumstances.

CO2 Automated Angiography in Endovascular Aortic Repair Preserves Renal Function to a Greater Extent Compared with Iodinated Contrast Medium. Analysis of Technical and Anatomical Details.

BACKGROUND: Contrast induced nephropathy occurs in up to 7.5% of cases in endovascular aortic repair (EVAR). Carbon dioxide (CO2) has been proposed as an alternative agent to iodinated contrast medium (ICM); however, specific protocols are not universally adopted, and the visualization of the renal arteries may be suboptimal in some cases. The aim of this study was to analyze our CO2-EVAR experience with automatic injections, in order to identify the anatomical characteristics associated with the best visualization of all the aortic vessels, with particular attention to the lowest renal artery (LoRA). METHODS: From 2016 to 2019, all EVAR performed with either CO2 or ICM were analyzed and compared. CO2-EVAR was performed using an automated injector (600 mm Hg pressure; 100 cc volume); a small amount of ICM was injected in case of difficulty in LoRA visualization or doubts at the completion angiogram. Clinical and CT-Scan preoperative characteristics were considered. The study endpoints were technical success, amount of ICM and radiation dose, postoperative renal function and possible CO2-related adverse events. Statistical analysis was by Fisher's exact, t-Student, Mann-Whitney tests and ROC curve. RESULTS: In the considered period, 321 EVAR procedures, 72 (22.4%) with CO2 and 249 (77.6%) with ICM, were performed. The 2 groups were similar for clinical characteristics and preoperative renal function. ICM was injected in a significantly lower amount in the CO2-EVAR group (52.8 ± 6.1 vs. 88.1 ±9.2 cc, P < 0.001), which received a significantly higher mean radiation dose (Total DAP: 500,550.8 ± 377,394.6 mGy/cm2 CO2-EVAR vs. 332,301.8 ±230,139.3 mGy/cm2 ICM-EVAR, P = 0.001). Postoperative eGFR decreased significantly less in the CO2-EVAR (2.3 ± 1.1 mL/min) compared with the ICM-EVAR group (10.6 ±5.3 mL/min), P < 0.001. LoRA was correctly visualized in 50/72 (69.4%) cases of CO2-EVAR, which had a significantly longer proximal neck (Median [IQR]: 30 [14] vs. 18 [15] mm, P = 0.001). At ROC curve, a proximal neck length >24.5 mm was predictive of LoRA visualization (72.1% sensitivity, 73.8% specificity). Three CO2-EVAR cases had intraoperative transient hypotension with no consequences. Sixteen/72 (22.2%) CO2-EVAR procedures were performed using 0 cc of ICM. CONCLUSIONS: CO2-EVAR by automated injections is safe and requires a lower amount of ICM if compared with ICM-EVAR, with a consequent significant benefit on postoperative renal function. If specific anatomical situations are present, ICM may be completely unnecessary. The radiation dose is however significantly higher, therefore procedural protocols need further refinements.

Reinterventions after fenestrated and branched endografting for degenerative aortic aneurysms.

OBJECTIVE: Fenestrated/branched endovascular abdominal aortic aneurysm repair (F/B-EVAR) is widely accepted technique to treat juxta/pararenal abdominal aortic aneurysms (J/P-AAAs) and thoracoabdominal aortic aneurysms (TAAAs) for patients at high-surgical risk. However, the follow-up results should be carefully evaluated, especially in terms of the reintervention rate. The aim of the present study was, therefore, to evaluate the early and mid-term reinterventions after FB-EVAR for J/P-AAAs and TAAAs and their effects on follow-up survival. METHODS: From 2006 to 2019, all consecutive patients who had undergone F/B-EVAR for J/P-AAAs or TAAAs were prospectively enrolled. Cases requiring reinterventions were retrospectively analyzed. Patients with aortic dissection were excluded from the present analysis. Reinterventions were classified as follows: access related, aortoiliac related, or target visceral vessel (TVV) related. Freedom from reintervention and survival were assessed using the Kaplan-Meier method, and univariate and multivariate analyses were used to determine the risk factors. RESULTS: Overall, 221 F/B-EVAR procedures were performed for 111 J/P-AAAs (50.3%) and 110 TAAAs (49.7%) in an elective (182; 82%) or urgent (39; 18%) setting. The median follow-up was 27 months (interquartile range, 13 months). Overall, 41 patients had undergone 52 reinterventions (single, 30 [14%]; multiple, 11 [5%]; access related, 17 [33%]; aortoiliac related, 6 [12%]; TVV related, 29 [55%]). Of the 52 reinterventions, 32 (62%) and 20 (38%) had occurred within and after 30 days, respectively. Eight reinterventions (15%) had been were performed in an urgent setting. Endovascular and open reinterventions were performed in 32 (62%) and 20 (38%) cases, respectively. Open reinterventions were frequently access related (access, 16; no access, 4; P ≤ .001). Technical success was 95% (39 patients); failures consisted of one splenic artery rupture and one renal artery loss. Patients undergoing reintervention had more frequently undergone a primary urgent F/B-EVAR (urgent, 12 of 39 [31%]; elective, 29 of 182 [16%]; P < .001) and had had TAAAs (TAAAs, 34 of 41 [83%]; J/P-AAAs, 7 of 41 [17%]; P < .001). The patients with TAAAs had had a greater incidence of TVV-related reintervention (TAAAs, 26 of 28 [93%]; J/P-AAAs, 2 of 28 [7%]; P < .001) and multiple reinterventions (TAAAs, 9 of 11 [82%]; J/P-AAAs, 2 of 11 [18%]; P = .03) compared with those with J/P-AAAs. Survival at 3 years was 75%. Freedom from reintervention was 81% at 3 years. Patients who had undergone reinterventions had lower 3-year survival (reintervention, 61%; no reintervention, 77%; P = .02). Preoperative chronic renal failure (hazard ratio [HR], 2.0; 95% confidence interval [CI], 1.1-3.6; P = .02), TAAAs (HR, 2.3; 95% CI, 1.1-4.8; P = .03), and urgent primary F/B-EVAR procedures (HR, 2.5; 95% CI, 1.2-4.9; P = .01) were independent predictors of late mortality. CONCLUSIONS: Reinterventions after F/B-EVAR are not uncommon and were related to TVVs in only one half of cases. Most of them can be performed in an elective setting using endovascular techniques. The technical success rate was excellent. Reinterventions were more frequent after TAAAs and urgent F/B-EVAR procedures and had a significant effect on overall survival in these situations.

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

BACKGROUND: 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. METHODS: 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. RESULTS: 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 ± 2 mm with no differences among JAAAs (52 ± 1 mm), PAAAs (42 ± 2 mm), and type IV-TAAAs (50 ± 2 mm) (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 80 mm. One BI was caused by acute thrombosis of the bridging stent graft for the superior mesenteric artery at 24 hours 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 ± 29 mm) and without (48 ± 23 mm) RFW (P.2). The 30-day mortality was 1.4%. The mean follow-up was 37 ± 2 months with no cases of aneurysm-related late mortality. Survival was 94%, 89%, and 75% at 1, 2, and 5 years, respectively. TVV patency was 97%, 97%, and 93% at 1, 2, and 5 years, respectively. FFR was 98%, 95%, and 87% at 1, 2, and 5 years, respectively. CONCLUSIONS: Custom-made FEVAR requires a mean proximal additional aortic coverage of 48 ± 2 mm 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.

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

BACKGROUND: Contrast-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]). METHODS: Between 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. RESULTS: Forty-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. CONCLUSIONS: CO2 + 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.

Endovascular Repair of a Common Carotid Artery Perforation during Pacemaker Insertion.

BACKGROUND: We report the percutaneous endovascular management of an iatrogenic perforation of the left common carotid artery (LCCA) during an attempted trans-subclavian pacemaker (PM) placement. METHODS: An 87-year-old woman was urgently transferred after an attempted left subclavian vein PM implantation. Computed tomography angiography scan showed the accidental cannulation of LCCA in its most proximal segment. Owing to the significant surgical risks, the mortality rate, and the distal position of the vessel from the skin, we opted for an endovascular strategy with a balloon-expandable stent graft. The Advanta 8 × 38 mm V12 was inserted via a 7 French Flexor Introducer sheath through the right common femoral artery. RESULTS: The patient was discharged on postoperative day 2 without complications. A 6-month follow-up computed tomography angiography demonstrated stent graft and LCCA patency and the patient was in a good stable condition. CONCLUSIONS: This case highlights the effectiveness of a minimal invasive endovascular approach to treat this uncommon but potentially lethal injury.

The Combined Use of a Distal Self-Expandable and Proximal Balloon-Expandable Stent Graft in Bridging Hostile Renal Arteries in Thoracoabdominal Branched Endografting.

BACKGROUND: To evaluate early/midterm outcomes of a specific configuration of a bridging stent graft-that is a distal self-expandable (SE) stent graft combined with proximal balloon-expandable (BE) one-in hostile renal artery (RA) anatomy in branched thoracoabdominal aneurysm (TAAA) repair. METHODS: Between 2010 and 2019, all TAAAs undergoing fenestrated and branched endografting (FB-EVAR) were prospectively collected. Preoperative, procedural, and postoperative data of RAs accommodated by branch design and patent at the completion angiography were retrospectively analyzed. Hostile RA anatomy included upward (type B) and downward + upward (type D) orientations. Type B and D RAs treated by the combination of an SE + BE stent graft as a bridging stent (BE + SE group) were compared with RAs treated by a BE stent graft only (BE group). RA occlusion, reinterventions, and branch instability were assessed. RESULTS: Over a total of 112 TAAAs undergoing FB-EVAR, 189 RAs were treated by fenestrations (113-60%) and branches (76-40%). Among the 66 (86%) RAs accommodated by branch and patent at completion angiography, 55 had a type B/D orientation. BE stent grafts were used in 15/55 (27%) RAs and SE + BE in 40/55 (73%). At a median follow-up of 12 (8) months, 5/55 (9%) RAs occluded: 4/15 (27%) in the BE group and 1/40(2.5%) in the SE + BE group (P: 0.017). RA patency was 83 ± 5% at 24 months. The SE + BE group had higher patency than the BE group (90 ± 5% vs. 68 ± 5% at 12 months; P: 0.039). Overall freedom from RA-related reinterventions was 87 ± 5% at 24 months. Six (9%) RAs required reinterventions: 4/15 (27%) in the BE group and 2/40 (5%) in the BE + SE group (P: 0.041). RAs managed by an SE + BE stent graft had lower reinterventions than RAs treated by a BE stent graft only (93 ± 5% vs. 76 ± 5% at 12 months; P: 0.01). Freedom from branch instability was 78 ± 5% at 24 months, with 8 overall cases (12%) occurring-5/15 (33.3%) in the BE group versus 3/40 (7.5%) in the SE + BE group (P: 0.02). RAs managed by an SE + BE stent graft had lower branch instability than RAs treated only by a BE stent graft (BE: 68 ± 5% vs. SE + BE: 80 ± 5% at 12 months; P: 0.02). CONCLUSIONS: In hostile renal anatomy, the combination of a distal SE and proximal BE stent graft as a bridging stent in branched endografting is safe and effective with lower rates of occlusion, reinterventions, and branch instability at midterm follow-up compared with a BE stent graft alone.

Long-term Efficacy of EVAR in Patients Aged Less Than 65 Years with an Infrarenal Abdominal Aortic Aneurysm and Favorable Anatomy.

BACKGROUND: The aim of this study was to compare early and long-term outcomes of endovascular aneurysm repair (EVAR) versus open surgical repair (OSR) in patients aged ≤ 65 years. METHODS: Data of patients aged ≤65 years undergoing infrarenal abdominal aortic aneurysm repair, between 2005 and 2013, were retrospectively reviewed. All EVAR procedures were performed according to the instruction for use, and only OSR procedures with an infrarenal aortic cross-clamping were included in the study. RESULTS: In this group of 115 patients (EVAR: 58 patients, 51% and OSR: 57 patients, 49%), EVAR and OSR patients had similar comorbidities, except for obesity (EVAR: 38% vs. OSR: 19%; P = 0.03). A stay in the intensive care unit (ICU) was necessary in 19% of patients with EVAR versus 79% with OSR (P = 0.001), and the amount of blood transfusion was 236 ± 31 mL for EVAR versus 744 ± 98 mL for OSR (P = 0.001). The hospital stay was 4 ± 2 days for EVAR versus 9 ± 6 days for OSR (P = 0.03). The overall 30-day mortality was 1% (EVAR: 0% vs. OSR: 2%; P = 0.30). Five patients (4%) required reinterventions within 30 days (EVAR: 0% vs. OSR: 8%, P = 0.001). The mean follow-up was 86 ± 38 months. Freedom from reintervention at 10 years after EVAR was 81% versus OSR 74%; (P = 0.77). Late reinterventions were reported in 13 patients (23%) with OSR and in 10 patients (17%) with EVAR. Postoperative retrograde ejaculation occurred more often in patients with OSR (31%) versus EVAR (2%) (P = 0.001). During the follow-up, cancer was found in 19 (17%) patients with no difference between EVAR and OSR (P = 0.83). The global survival at 10 years was 72% (EVAR: 79% vs. OSR: 70%; P = 0.94). CONCLUSIONS: In this study, EVAR was associated with a shorter hospital stay, less need for the ICU, and less early reinterventions than OSR. Survival and reinterventions during the follow-up were not significantly different between EVAR and OSR. According to these results, EVAR may be considered for patients aged ≤65 years with a favorable anatomy.

Early and Mid-term Efficacy of Fenestrated Endograft in the Treatment of Juxta-Renal Aortic Aneurysms.

BACKGROUND: The aim of this study was to report early and mid-term outcomes of fenestrated endografting (FEVAR) for juxtarenal aneurysm (J-AAAs). METHODS: Between 2008 and 2017, all consecutive J-AAAs treated by FEVAR were prospectively collected. Early endpoints were technical success, renal function worsening, and 30-day mortality. Follow-up endpoints were survival, freedom from reinterventions (FFRs), target visceral vessels (TVVs) patency, J-AAAs shrinkage, and renal function worsening. RESULTS: Among 181 cases who underwent FB-EVAR, 66 (36%) were J-AAAs. Endograft with 1, 2, 3, and 4 fenestrations were planned in 2 (3%), 22 (33%), 27 (41%) and 15 (23%) cases, respectively. Overall, 236 TVVs were treated by fenestrations and scallops. Technical success was achieved in 65 (99%) cases. The only failure occurred for a type III endoleak requiring renal artery relining. No TVVs were lost. Renal function worsening occurred in 7 (10%) cases: 4 returned to baseline within 30-day, 1 required hemodialysis and died within 30 days (1.5%). This was the only case of 30-day mortality. The mean follow-up was 46 ± 32 months. Aneurysm sac shrinkage or stability was observed in 42 (64%) and 22 (33%) cases, respectively. Two patients (3%) with persistent type II endoleak had sac enlargement and required reinterventions. Freedom from reinterventions at 5 years was 88%. An asymptomatic celiac trunk occlusion (accommodated by a scallop) occurred at 24 months in a case with a severe preoperative stenosis. No late renal arteries occlusions or type I-III endoleaks occurred. Overall, renal function worsening was reported in 5 (8%) patients during follow-up. Survival at 5 years was 67%, with no j-AAA-related mortality. COPD was the only independent predictor for mortality at the multivariate analysis (P: 0.021; OR: 5.3; 95% CI, 1.3-21.9). CONCLUSIONS: FEVAR for J-AAAs is safe and effective at early and mid-term follow-up. According to these results, it could be proposed as the first-line treatment in high-risk patients if anatomically fit. Long-term survival is reduced in the presence of preoperative COPD.

First/Preliminary Experience of Gore Viabahn Balloon-Expandable Endoprosthesis as Bridging Stent in Fenestrated and Branched Endovascular Aortic Repair.

BACKGROUND: The aim of this study is to evaluate the preliminary outcomes of the Gore® Viabahn® balloon-expandable endoprosthesis (VBX) as bridging stent for fenestrated/branched aortic endograft. METHODS: Between April and June 2018, patients undergoing fenestrated and branched-endovascular aortic repair were prospectively collected. Anatomical, procedural, and postoperative data of patients treated with VBX as bridging stents to connect fenestrations/branches to target visceral vessels (TVVs) were analyzed. Technical success and any TVV-related adverse event were assessed before discharge, at 30 days, and after 6 months of follow-up. RESULTS: Fifteen patients undergoing fenestrated and branched-endovascular aortic repair for juxta/pararenal aneurysms (11), proximal type I endoleak after endovascular aortic repair (1), and thoracoabdominal aneurysms (3) were included in the study. Overall, 60 TVVs-celiac trunk (n = 14), superior mesenteric artery (n = 13), renal arteries (n = 30), hypogastric artery (n = 3)-were accommodated by fenestrations (n = 51), branches (n = 7), and scallops (n = 2). The bridging stent graft was a VBX in 40 (67%) TVVs. A renal artery dissection was successfully managed by a self-expandable bare metal stent. Overall, relining of a bridging stent graft was required in 2 TVVs revascularized by fenestrations (superior mesenteric artery: n = 1, renal artery: n = 1). One intraoperative type III endoleak from renal fenestration was detected and successfully sealed by an adjunctive flaring maneuver. Technical success was achieved in all cases. At 5-day, 1 VBX (1/40: 2.5%) lost its sealing in a renal artery revascularized by a branch (type II thoracoabdominal aortic aneurysm) and required reintervention and relining with a self-expandable stent graft. No TVV occlusion or reintervention occurred <30 days or after 6 months of follow-up. CONCLUSIONS: According to these preliminary results, the Gore Viabahn VBX balloon-expandable endoprosthesis can be safely used as bridging stent graft for fenestrated or branched endografts. A longer follow-up with a larger case load is necessary in order to validate this preliminary experience.

Determination of the gained proximal sealing zone length after debranching of the left subclavian artery in thoracic endovascular aortic repair.

BACKGROUND: For descending thoracic aortic aneurysms (TAA) in proximity of the aortic arch, debranching of the left subclavian artery (LSA) may be necessary to extend proximal sealing in zone 2. The aim of this study was to determine the added proximal apposition length gained from LSA debranching during thoracic endovascular aortic repair (TEVAR). METHODS: This multicenter retrospective study (2010-2020) included patients who underwent elective TEVAR in zone 2 for a degenerative TAA where the LSA was surgically debranched. The endograft position on the first postoperative computed tomography angiography (CTA) scan was assessed using post-processing software. The analysis included the shortest apposition length (SAL), the tilt of the proximal edge of the endograft, and the distance between the endograft and the left common carotid artery. Clinical endpoints (neurological complications and endoleaks) at 30 days were also reported. RESULTS: Twenty-two patients were included. The median interval between TEVAR and the first postoperative CTA was 3 days (2-10 days). Median SAL was 9.2 mm (1.3-26.4 mm), of which 8.6 mm (1.3-16.2 mm) was gained proximal of the LSA, including the LSA orifice. In 12 patients (55.5%) the SAL was <10 mm. The median tilt was 18.3° (13.9°-22.2°). Seven endoleaks were reported on the first CTA: 1 type Ia, 2 type Ib, 3 type II, and 1 type III. CONCLUSIONS: Debranching the LSA adds valuable sealing length in zone 2, but the SAL was still relatively short in many patients, putting these patients at risk for a future type Ia endoleak. Accurate assessment of the circumferential apposition on postoperative CTA follow-up in these high-risk patients with short, complex landing zones seems mandatory. Evaluation of apposition in a larger population with longer follow-up is advised.

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

OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.