Early and Mid-Term Outcomes of the Inverted Limb Configuration Below Fenestrated and Branched Endografts: Experience from Two European Centers.

PURPOSE: To report a European experience on the use of the Inverted Limb (IL) below fenestrated and branched endografts (FB-EVAR) for the treatment of juxta/pararenal (JP-AAAs), thoracoabdominal (TAAAs), and para-anastomotic aortic aneurysms. MATERIALS AND METHODS: Between 2016 and 2020, all FB-EVAR with distal IL due to previous open (OSR) or endovascular repair (EVAR) or infrarenal aortic length <76 mm at two European university centers were retrospectively analyzed. Technical success, early and mid-term iliac complications (occlusion; type Ib endoleak [EL]), IL-related complications (type III EL), and reinterventions were assessed as primary endpoints; 30-day mortality, survival and freedom from (FF) overall complications/reinterventions were assessed as secondary outcomes. RESULTS: Forty-one high-risk patients (male 30%-73%; mean age 71±10 years; ASA 3-4, 41%-100%) underwent FB-EVAR with distal IL for 8 (19.5%) J/P-AAAs and 33 (80.5%) TAAAs. Sixteen (39%) patients with previous aortic treatment (8 OR, 8 EVAR) were included. Preoperative computed tomographic angiography showed infrarenal aortic length <76 mm in all cases. Custom-made endografts were configured as 31 (75.6%) fenestrated-only, 6 (14.6%) branched-only, and 4 (9.8%) fenestrated+branched for an overall of 158 target visceral vessels (TVVs; 3.8±0.7 TVVs/case). The IL main body was planned with 1-stent, 2-stents, and 3-stents in 6 (14.6%), 23 (56.1%), and 12 (29.3%) cases, respectively. Technical success and 30-day mortality were 97.6% (40/41) and 0%. Thirty-day complications occurred in 2 (4.9%) patients: 1 limb occlusion, requiring reintervention, 1 type III EL, spontaneously resolved. Mean follow-up was 21±16 months. Three After 30-day, 3 (7.3%) iliac complications (2 occlusions; 1 type Ib EL) were successfully managed by endovascular reinterventions; no IL-related complications were observed. The patency of TVVs was 96.8%. No correlation between anatomical characteristics, endograft configuration, and primary outcomes was observed, except for 1-stent IL and type III EL (log rank p=0.01). At 1- and 2-year follow-up survival, FF overall iliac/IL-related complications and FF reinterventions were 90% and 80%, 90% and 84%, and 92% and 87%, respectively. CONCLUSION: The IL configuration allows a safe endovascular treatment of challenging aortic lesions in high-risk patients although needing a number of adjunctive procedures. A short main body of IL could be associated with intraoperative and perioperative type III EL. CLINICAL IMPACT: Bifurcated endograft with inverted limb configuration increases the feasibility of a total endovascular approach in patients with challenging anatomy. The use of inverted limb overcomes the anatomical limitations of short-body initial grafts and short distance between lowest target artery and the aortic bifurcation, leading the fixation inside the endograft. Although technically demanding, this advanced technology could avoid surgical reinterventions in previous open or endovascular repair that are burdened with higher rates of morbidities and complications.

Effect of iliac tortuosity on outcomes after iliac branch procedures.

OBJECTIVE: To report a two-centers evaluation of the effects of iliac axis tortuosity on iliac branch device (IBD) results. METHODS: From 2015 to 2021, all IBD procedures performed at two European centers were analyzed retrospectively. The preoperative pelvic tortuosity index (PTI), external tortuosity index (ETI), and double iliac sign (DIS) were assessed for each iliac axis submitted to IBD. The primary endpoints were technical success, early and mid-term IBD complications (occlusion, stenosis, endoleaks [ELs]) and reinterventions, and the association with the PTI, ETI, and DIS. The 30-day mortality, survival, freedom from complications and freedom from reinterventions (FFR) were the secondary endpoints. RESULTS: During the study period, 224 patients had undergone 256 IBD procedures for 165 (64.5%) aortoiliac aneurysms, 44 (17.2%) isolated iliac aneurysms, 11 (4.3%) abdominal aortic aneurysms with a short iliac landing zone, and 36 (14.1%) type Ib ELs. IBD was planned with endovascular aortic aneurysm repair for 158 (61.7%), fenestrated/branched endovascular aortic aneurysm repair for 45 (7.6%), and isolated for 53 (20.7%) cases. Technical success and 30-day mortality were 99.2% (254 of 256) and 0.9% (2 of 224), respectively. A PTI >1.4, an ETI >1.7, and the DIS were tested to identify the risk factors for the endpoints. No ELs and 9 (3.5%) IBD occlusions, requiring five reinterventions (2%), had occurred within 30 days. No association with the PTI, ETI, or DIS was identified; IBD oversizing of ≥25% on the external iliac artery was independently related to occlusion (odds ratio, 4.3; 95% confidence interval [CI], 1-18.1; P = .045). The mean follow-up was 31 ± 27 months, with 11 IBD occlusions, 14 ELs, and 21 reinterventions. At 1, 3, and 5 years of follow-up survival, IBD patency, and FFR were 95%, 89%, and 80%; 93%, 91%, and 90%; and 93%, 89%, and 83%, respectively. The risk factors for overall complications (n = 34; 13.3%) and reinterventions (n = 26; 10.2%) were an ETI >1.7 (P = .037 and P = .019), a PTI >1.4 (P = .016 and P = .012), and a type Ib EL as the indication (P = .025 and P = .001), respectively. Cox regression confirmed PTI >1.4 as an independent predictor of overall complications and reinterventions (hazard ratio [HR], 2.3; 95% CI, 1.1-4.4; P = .018; and HR, 3 95% CI, 1.3-6.8; P = .018, respectively) and ETI >1.7 as an independent risk factor for ELs (HR 6; 95% CI, 2.1-17.5; P = .001). The freedom from complications and FFR were significantly lower with a PTI >1.4 at 3 years (73% vs 92% [log-rank P = .01] and 77% vs 93% [log-rank P = .001], respectively). CONCLUSIONS: We found IBDs to be safe and effective in the treatment of aortoiliac aneurysms. Early complications are uncommon and related to endograft oversizing rather than anatomic characteristics in the present study. Iliac tortuosity is a risk factor for overall complications and reinterventions, in particular for IBD-related ELs.

A cross-sectional study on the anatomic feasibility of iliac side branch grafts in a real-world setting.

OBJECTIVE: The aim of this cross-sectional, single-center study was to analyze the feasibility of different commercially available iliac branch devices in Europe in a cohort of patients with aorto-iliac aneurysms. METHODS: All patients with aorto-iliac or iliac aneurysms that required iliac aneurysm repair, between 2017 and 2021, were included. Morphologic data was analyzed using computed tomography angiograms. The main outcome was the feasibility of each endoprosthesis (Cook ZBIS, Gore Iliac Branch Endoprosthesis [IBE], and JOTEC E-Iliac) according to the manufacturer's instructions for use. Secondary outcomes were feasibility in all three devices, in any device, and with adjunctive procedures (liberal criteria). Additionally, a comparative analysis of all three grafts was performed to analyze differences in feasibility. RESULTS: Overall, 119 iliac aneurysms in 101 patients were included. The mean age was 71 ± 11 years, and 91.6% were male. Feasibility was 52.9% for Cook ZBIS, 33.6% for Gore IBE, and 26.9% for the JOTEC E-Iliac device. A total of 65.5% of patients were feasible with at least one device, whereas only 10.1% complied with all three devices. The main reasons for lack of feasibility were a short common iliac artery length (Cook ZBIS), a narrow common iliac artery diameter (Gore IBE), and a >50° angulation between the external and internal iliac arteries (JOTEC E-Iliac). There was a significant difference between the feasibility of the three devices (P < .001). Cook ZBIS was the graft with the higher feasibility, with 3.3 and 4.4 higher odds when compared with Gore IBE and JOTEC E-Iliac devices, respectively. There was no significant difference between the Gore IBE and the JOTEC E-Iliac. By using liberal criteria, the overall feasibility increased to 95.8%. CONCLUSIONS: We found that only 65.5% of patients were feasible with one of the available devices according to the manufacturer's instructions for use. The Cook ZBIS was the device with the overall highest feasibility. Extending the use of these devices with adjunctive measures and a more liberal approach increased feasibility to 95.8%.

Parallel Graft to Preserve a Reimplanted Inferior Mesenteric Artery During Thoracoabdominal Multibranched Endografting.

INTRODUCTION: Preserving pelvic circulation is crucial to minimize the risk of spinal cord and colonic ischemia, especially during the endovascular treatment of extended thoraco-abdominal aneurysm (TAAA) after previous open repair (OR). CASE REPORT: A 78-years-old patient, previously treated for AAA with OR and reimplantation of inferior mesenteric artery (IMA), has presented with 9 cm type-III TAAA and underwent to a multi-stage endovascular procedure. Two thoracic endografts, t-Branch and a straight endograft by Cook Zenith platform were deployed. Renal and superior mesenteric arteries were cannulated and revascularized. Through the left axillary access, a 5F-vertebral catheter was delivered over a 0.035 inch guidewire to selectively catheterize IMA. A post-anastomotic stenosis was stented to advance the sheath and the parallel-graft (Viabahn 7 × 150 mm, Gore) into the artery. Thus, a bifurcated endograft was deployed inside the previous OR. According to the Sandwich-Technique, the stentgraft was deployed parallel and outside the bifurcated device, inside the straight one and 2 cm into the IMA and then reinforced by a bare-metal-stent (Protégé EverFlex™ 7 × 120 mm, Medtronic). Finally, a kissing ballooning of iliac endografts and parallel-graft was performed. The procedure was completed five days later, by stenting the celiac trunk. Post-operative course was uneventful. The 36-months CTA showed the patency of the IMA with no complications. CONCLUSION: The combination of t-Branch and Sandwich-Technique for IMA could be employed to treat extended TAAA with previous OR and reimplanted IMA thus minimizing the risk of colonic and spinal cord ischemia.

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.

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.

The "Skewer Technique" for Stentgraft Delivery in the Aortic Arch: Advancing the Dilatator in The Innominate Artery Over a Right Femoro-Brachial Through-And-Through Wire.

BACKGROUND: Thoracic endovascular aortic repair (TEVAR) is the preferred treatment for different aortic pathologies, because it has reduced mortality and morbidity rates. However, TEVAR is not feasible in all cases due to aortic angulations, the hemodynamics of the aortic arch and narrow or tortuous iliofemoral access. Therefore, different adjuvant techniques, such as iliac percutaneous transluminal angioplasty, iliathrough-and-through guidewires and external transapical guidewires have been previously reported. Herein we describe the Skewer Technique for successful TEVAR delivery, through a right-brachial-femoral through-and-through guidewire and advancement of the delivery system into the innominate artery. METHODS: A 38-year-old male presented with a symptomatic 11.5cm thoracic aneurysm with involvement of the left-subclavian artery ostium. The patient underwent left carotid-subclavian bypass and a TEVAR. Due to the huge size of the aneurysm a left-brachial-right femoral artery through-and-through guidewire was established. However, the achievement of a stable position for the deployment of the stentgraft was not possible. Eventually, the exclusion of the aneurysm was done with a right brachio-femoral through-and-through wire, inserting the proximal part of the delivery system into the innominate artery. CONCLUSIONS: The use of adjuvant techniques such as a through-and-through right brachial-femoral guidewire with advancement of the endograft delivery system in the innominate artery (Skewer Technique) represents a useful alternative option in cases where the angulations of the aortic arch impede the deployment of the stent graft using conventional techniques.

Intracranial Hemorrhage After Endovascular Repair of Thoracoabdominal Aortic Aneurysm.

BACKGROUND: Intracranial hemorrhage (ICH) is a rare but devastating complication of thoracoabdominal aortic aneurysm (TAAA) repair with fenestrated/branched endograft (f/bEVAR). The cerebrospinal fluid drainage (CSFD) is considered one of the leading causes; however, other possible concomitant factors have not been individualized yet. The aim of the present work was to evaluate the pattern of ICH events after f/bEVAR for TAAA and to identify possible associated factors. MATERIALS AND METHODS: All f/bEVAR procedures for TAAA performed in a single academic center from 2012 to 2020 were evaluated. ICH was assessed by cerebral computed tomography if neurological symptoms arose. Pre-, intra-, and postoperative characteristics were analyzed in order to identify possible factors associated. RESULTS: A total of 135 f/bEVAR were performed for 72 (53%) type I, II, III and 63 (47%) type IV TAAA; 74 (55%) were staged procedures, 101 (73%) required CSFD, and 24 (18%) were performed urgently. The overall 30-day mortality was 8% (5% in elective cases); spinal-cord ischemia occurred in 11(8%) and ICH in 8 (6%) patients. All ICH occurred in patients with CSFD. ICH occurred intraoperatively in 1 case, inter-stage in 4 and after F/BEVAR completion in 3, after a median of 6 days the completion stage. Three (38%) of 8 patients with ICH died at 30 days and ICH was associated with 30-day mortality: odds ratio (OR) 13.2, 95% confidence interval (CI): 2.3-76, p=0.01. The analysis of the perioperative characteristics identified platelet reduction >60% (OR 11, 95% CI 1.6-77, p=0.03), chronic kidney disease (16% vs 0%, p=0.002), and total volume of liquor drained >50 mL (OR 8.1, 95% CI 1.1-69, p=0.03) as associated with ICH. CONCLUSIONS: Current findings may suggest that ICH is a potential lethal complication of the endovascular treatment for TAAAs and it mainly occurs in patients with CSFD. High-volume liquor drainage, platelet reduction, and chronic kidney disease seems increase significantly the risk of ICH and should be considered during the perioperative period and for further studies.

Tailored Sac Embolization During EVAR for Preventing Persistent Type II Endoleak.

BACKGROUND: Persistent type II endoleaks (ELIIp) occur in 8-23% of patients submitted to endovascular aneurysm repair (EVAR) and may lead to aneurysm progression and rupture. Intraoperative embolization of the abdominal aortic aneurysm (AAA) sac is effective to prevent their occurrence, however a method to achieve complete sac thrombosis has not been standardized yet. Aim of our study was to identify factors associated with prevention of ELIIp after intraoperative embolization, in order to optimize technical details. METHODS: Patients at high risk for ELIIp, who underwent EVAR with AAA - sac coil embolization were prospectively collected into a dedicated database from January 2012 to March 2015. The endoluminal residual sac volume (ERV), not occupied by the endograft [ERV= AAA total volume (TV) - (AAA-thrombus volume (THV) + endograft volume (EgV)] was calculated on preoperative computed tomography and the concentration of coils implanted (CCoil= n coils implanted/ERV) for each patient was evaluated. AAA volumetric evaluation was conducted by dedicated vessels analysis software (3Mensio). ELIIp presence was evaluated by contrast-enhanced ultrasound at 6 and 12-month. Patients with ELIIp at 12 months (Group 1) were clustered and compared to patients without ELIIp (Group 2), in order to evaluate the incidence of ELIIp in patients undergone to preventive AAA-sac embolization, and identify the predictors of ELIIp prevention. Morphological potential risk factors for ELIIp such as TV, THV, VR% and EgV were also considered in all patients. Statistical correlation was assessed by Fisher Exact Test. RESULTS: Among 326 patients undergone to standard EVAR, 61 (19% - M: 96.7%, median age: 72 [IQR: 8] years, median AAA diameter: 57 [IQR: 7] mm) were considered at high risk for ELIIp and were submitted to coil embolization. The median AAA total volume (TV) and median ERV were 156 (IQR: 59) cc and 46 (IQR: 26) cc, respectively. The median number and concentration of coils (IMWCE-38-16-45 Cook M-Ray) positioned in AAA-sac were 5 (IQR: 1) coils and 0.17 coil/cm3 (range 0.02-1.20). Among this high-risk population, the incidence of ELIIp was 29.5% and 23% at 6 and 12-month, respectively. Fourteen patients (23%) were clustered in Group1 and 47 (77%) in Group 2. Both groups were homogeneous for clinical characteristics and preoperative morphological risk factors. There were no differences in the preoperative median TV, AAA-thrombus volume (THV), %VR, EgV and number of implanted coils between Group1 and Group2. Patients in Group1 had a significantly higher ERV (59 [IQR: 13] cm3 vs. 42 [IQR: 27] cm3, P = 0.002) and lower CCoil (0.09 [IQR: 0.03] vs. 0.18 [IQR: 0.21], P = 0.006) than patients of Group2. ELIIp was significantly related to the presence of ERV > 49 cm3 (86 % vs. 42 %, Group1 and Group2 respectively, P = 0.006) and CCoil < 0.17coil/ cm3 (100% vs. 68%, Group1 e Group2 respectively, P = 0.014). CONCLUSION: According with our results, Coil concentration and endoluminal residual volume can affect the efficacy of the AAA - sac embolization in the prevention of ELIIp, moreover CCoil ≥0.17coil/ cm3 maight be considered to determine the tailored number of coils.

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.

"Flaring-Kissing Ballooning" of the Stentgrafts in Fenestrated Endograft Procedures to Ensure Target Visceral Vessels Patency.

PURPOSE: To describe a dedicated technique used in fenestrated endografting (FEVAR) for juxtarenal aneurysm (JAAA) to avoid intraoperative bridging stentgraft crushing in case of adjacent origin of left renal (LRA) and superior mesenteric (SMA) artery. CASE REPORT: A 78-year-old male, at high surgical risk, underwent FEVAR for JAAA. SMA and LRA fenestrations were adjacent, at 12:30 and 2:45 o'clock evaluation, respectively. The fenestrated endograft and the bridging stentgrafts for target visceral vessels (TVVs) were deployed without complications. The completion angiography and the cone-beam CT showed patency of TVVs, except for LRA, which showed crushing of its stentgraft. SMA and LRA were re-cannulated, and the renal stentgraft was dilated with a 4 × 40 mm balloon. Finally, "Flaring-Kissing ballooning" of SMA and LRA stentgrafts was performed using two 10 × 20 mm balloon under fluoroscopy rotational guidance, to ensure the patency of both arteries. The completion angiography and the postoperative CT-angiography showed the resolution of the crushing and the patency of TVVs. The postoperative course was uneventful; the patient was discharged home after 5 days. CT-angiography at 12 months showed patency of TVVs and no endoleaks. CONCLUSIONS: The "Flaring-Kissing ballooning" of adjacent stentgrafts is a valid, safe and effective intra-procedural maneuver to preserve the patency of the TVVs.

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

OBJECTIVE: 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). METHODS: 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 24 h 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. RESULTS: 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 ± 6 mm. 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 24 h. 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. CONCLUSION: 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 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.

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.

Predictors of Survival in Patients Over 80 Years Old Treated with Fenestrated and Branched Endograft.

BACKGROUND: Fenestrated and branched endovascular aneurysm repair endograft (f/bEVAR) allows the endovascular repair of thoracoabdominal and juxtarenal and pararenal abdominal aortic aneurysms (T-J-P-AAAs); however, given their high cost and complexity, their use should be limited to patients with life expectancy >2 years. Nevertheless, the number of patients older than 80 years treated by f/bEVAR is growing, with no hard evidence of the real efficacy in this context. The aim of the present study is to analyze the survival of ≥80-year-old patients treated with f/bEVAR, and to identify possible predictors of late mortality. METHODS: An analysis of clinical, anatomical, and technical characteristics of patients treated with f/bEVAR for J-, P-, and T-AAA from 2010 to 2019 in a single academic center was performed. Follow-up data were collected prospectively with clinical visit and computed tomography angiography at discharge, after 6 months, and yearly thereafter. Survival after 2 years was evaluated by Kaplan-Meier analysis. Possible predictors of mortality were evaluated by univariable/multivariable analysis. RESULTS: In the study period, a total of 243 f/bEVARs were considered: 83 for TAAA (34%) and 160 for J/PAAA (66%). Mean age was 73 ± 6 years, with 35 (14%) patients ≥80 years old; 209 patients (86%) were male and 78 (39%) had an American Society of Anesthesiology score IV. The 30-day and 2-year survival were 96% and 80 ± 3%, respectively. At a mean follow-up of 36 ± 25 months, independent predictors of late mortality by Cox regression analysis were chronic obstructive pulmonary disease (COPD), chronic renal failure (CRF), and ≥80 years old (hazard ratio [HR] 1.8, 95% confidence interval [CI] 1.02-3.2, P = 0.05; HR 1.7, 95% CI 1.01-3.4, P = 0.04; HR 3.1, 95% CI 1.5-6.3, P = 0.002, respectively). Preoperative clinical characteristics were similar in ≥80 years old versus younger patients, except for the prevalence of TAAA (14% vs. 38%, P = 0.04). The technical success and 30-day mortality were similar in ≥80 vs. <80-year-old patients (93% vs. 96%, P = 0.31; 7% vs. 3.5%, P = 0.60, respectively). The 2-year survival estimation was significantly lower in ≥80 years old compared with younger patients (62 ± 10% vs. 82 ± 3%, P = 0.003). The association of COPD and CRF significantly affects the 2-year survival in ≥80-year-old patients (no patients survived at 2 years) and was significantly different compared with the survival in ≥80-year-old patients without these risk factors (70 ± 11%, P = 0.001). CONCLUSIONS: The early mortality rate and the 2-year survival after f/bEVAR justify this type of treatment in patients ≥80 years old; however, the presence of comorbidities such as COPD and CRF significantly reduces mid-term survival in this group and should be taken into consideration in the indication to f/bEVAR.

Different Drugs Effect on Mesenchymal Stem Cells Isolated From Abdominal Aortic Aneurysm.

BACKGROUND: Abdominal aortic aneurysm (AAA) is a progressive dilation of the aortic wall, determined by the unbalanced activity of matrix metalloproteinase (MMPs). In vitro and in vivo studies support the pivotal role of MMP-9 to AAA pathogenesis. In our experience, we elucidated the expression of MMP-9 in an ex vivo model of human mesenchymal stem cells isolated from AAA specimen (AAA-MSCs). Thus, MMP-9 inhibition could be an attractive therapeutic strategy for inhibiting AAA degeneration and rupture. Our study was aimed at testing the effect of 3 different drugs (pioglitazone, doxycycline, simvastatin) on MMP-9 and peroxisome proliferator-activated receptor (PPAR)-γ expression in AAA-MSCs. METHODS: Aneurysmal aortic wall segments were taken from AAA patients after the open surgical treatment. MSCs were isolated from AAA (n = 20) tissues through enzymatic digestion. AAA-MSCs were exposed to different doses of pioglitazone (5-10-25 µM), doxycycline (10-25 µM), and simvastatin (10 µM) for 24 h. The effect of each drug was evaluated in terms of cell survival, by crystal violet stain. MMP-9 and PPAR-γ mRNA were analyzed using real-time PCR. RESULTS: AAA-MSCs were not affected by the exposure to the selected drugs, as shown by the analysis of cell viability. Interestingly, MMP-9 mRNA resulted significantly decreased after each treatment, recording a downregulation of 50% in presence of pioglitazone, 90% with doxycycline, and 40% with exposed to simvastatin, in comparison to untreated cells. We further analyzed the expression of PPAR-γ, target of pioglitazone, observing an upregulation in exposed AAA-MSCs to controls. CONCLUSIONS: Our data support the potential therapeutic effect of pioglitazone, doxycycline, and simvastatin on AAA by reducing the MMP-9 expression in a patient-specific model (AAA-MSCs). In addition, pioglitazone drives the increase of PPAR-G, another promising target for AAA therapy. Further studies are necessary to elucidate the mechanism driving this inhibitory pathway, which can reduces the mortality risk associated with AAA rupture.

The different effect of branches and fenestrations on early and long-term visceral vessel patency in complex aortic endovascular repair.

BACKGROUND: Aortic endovascular treatment with fenestrated or branched devices (f/bEVAR) requires a connection between the aortic graft and the visceral vessel (VV). However, data on the perioperative and long-term fate of the VVs remain scarce. The aim of our study was to evaluate the VV loss (VVL) according to the type of revascularization performed (fenestrations vs branched) and the necessity for adjunctive visceral procedures (AVPs). METHODS: From 2012 to 2017, all f/bEVAR procedures for juxtarenal abdominal aortic aneurysms (JAAAs), pararenal abdominal aortic aneurysms (PAAAs), and thoracoabdominal aortic aneurysms (TAAAs) were considered. The perioperative VVL, AVPs, and graft configuration were considered and evaluated during the follow-up period. RESULTS: In 158 patients, 523 VVs were considered, 140 (26%) in JAAAs, 165 (32%) in PAAAs, and 218 (42%) in TAAAs. Branches were used for 114 vessels (52%) in TAAAs, 8 (5%) in PAAAs, and 0 (0%) in JAAAs. The overall perioperative VVL was 20 (3.8%) and was significantly greater in TAAAs than in PAAAs or JAAAs (6.4% vs 2.4% vs 1.4%; P = .03). The branches resulted in greater perioperative VVL compared with fenestration (9% [11 of 122] vs 2% [9 of 401]; P = .0001). A significant VVL difference between the branches and fenestrations was identified selectively only for the renal arteries: 11 of 52 (21%) vs 6 of 224 (2.5%; P = .001). The results of the multivariate analysis confirmed the independent greater risk of VVL for branches and renal arteries (odds ratio, 4.7; 95% confidence interval, 12.5-1.7; P = .04; odds ratio, 7.1; 95% confidence interval, 52.6-1.05; P = .05, respectively). AVPs were performed in 43 VVs (8.2%) because of dissection (n = 2; 0.4%), stenosis (m = 3; 0.6%), bleeding (n = 3; 0.6%), or kinking between the bridging stent graft and the VV (n = 35; 7%). A significant difference between the branches and fenestrations was seen only for kinking between the bridging stent graft and VV (12% [15 of 112] vs 5% [20 of 401]; P = .005). At 5 years, the incidence of VVL was 2% ± 1%. The fenestrations had significantly greater freedom from VVL compared with the branches (100% vs 87% ± 6%; P = .04), which was confirmed selectively for TAAAs (100% vs 87% ± 6%; P = .04). The use of AVPs did not affect long-term visceral patency. CONCLUSIONS: Early and late VVL was infrequent in complex aortic procedures but seemed to occur more frequently in branches than in fenestration, especially for renal arteries. AVPs were often required to correct artery kinking but this did not affect the long-term patency.

Predictors of survival in malignant aortic tumors.

OBJECTIVE: Malignant aortic tumors (MATs) are exceedingly rare, and a comprehensive review of clinical and therapeutic aspects is lacking in the literature. The aim of this study was to analyze all known cases of MATs and to identify predictors of patients' survival. METHODS: All patients diagnosed with an aortic tumor treated in a single center along with all case reports and reviews available in the literature through a specific PubMed search using keywords such as "malignant" and "aorta" or "aortic," "tumor," or "sarcoma" or "angiosarcoma" were analyzed. The tumor's primary location, clinical presentation, histologic subtype, and treatment choice were examined. Survival at 1 year, 3 years, and 5 years and the possible preoperative and operative outcome predictors were evaluated using Kaplan-Meier analysis with a log-rank test and by Cox regression for multivariate analysis. RESULTS: In addition to the 5 cases treated in our center, 218 other cases of MAT were reported in the literature from 1873 to 2017. The mean age of the patients was 60.1 ± 11.9 years, and the male to female ratio was 1.59:1. The median overall survival from diagnosis was 8 (7-9) months; 1-, 3-, and 5-year survival rates were 26%, 7.6%, and 3.5%, respectively. Chronic hypertension (P = .03), fever (P = .03), back pain (P = .01), asthenia (P = .04), and signs of peripheral embolization (P = .007) were significant predictors of a poor result. Histologic subtypes had a different impact on survival, with no statistical significance. Compared with other treatment strategies, combined surgical-medical therapy had the best impact on the median survival rate (surgical-medical, 12 [8-24] months; medical, 8 [5-10] months; surgical 7 [2-16] months; no treatment, 2 [0.5-15] months; P = .001). Analyzing exclusively medical approaches, chemotherapy and radiotherapy had the best impact on median survival rate compared with untreated patients (chemotherapy-radiotherapy, 18 [10-26] months; radiotherapy, 16 [8-20] months; chemotherapy, 10 [7-24] months; no medical treatment, 6 [2-16] months; P = .005); these data were not sustained by multivariate analysis. CONCLUSIONS: Aortic tumors are a malignant pathologic condition with a short survival rate after initial diagnosis. Survival is further diminished in the presence of clinical factors such as hypertension, fever, back pain, asthenia, and signs of peripheral embolization. Combined surgical and medical treatment, particularly with chemotherapy and radiotherapy, has shown the highest survival rate.

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.