Medium-term outcomes of EXTra-design engineering inner-branch ENdografts for the treatment of complex aortic aneurysms from a multicenter collaboration.

OBJECTIVE: This study aims to present the medium-term outcomes of Extra-Design engineering endografts with inner branches (EDE-iBEVARs, Artivion) in endovascular aortic repairs of complex aneurysms building upon promising early results. METHODS: A retrospective, international, multi-center study was conducted including consecutive patients who underwent complex endovascular aortic repairs using EDE-iBEVARs between 2018 and 2022. Patient demographics, aneurysm anatomical features, procedural details, reinterventions, complications, and endograft failures during follow-up were assessed. The primary outcome was aneurysm-related mortality. Secondary outcome measures included the freedom from all-cause mortality and reintervention, technical and clinical success, and late related complications including branch instability, endoleaks, and serious adverse events. RESULTS: Our study encompassed a total of 260 patients across 13 European centers. The cohort included patients with thoracoabdominal aortic aneurysms (n = 116), suprarenal or juxta-renal aneurysms (n = 95), and those who had previous open repair or previous endovascular aortic repair with type 1A endoleak (n = 49). Of 982 possible inner branches (937 antegrade and 45 retrograde), 962 (98%) were successfully cannulated and bridged with covered stents during the index procedure. Overall, the endograft was successfully deployed in 98% of patients, and 93% were discharged from hospital following surgery. At 3 years, freedom from aneurysm-related mortality was 97%, whereas the freedom of all-cause mortality was 89%. Freedom from reinterventions was 91% and 76% at 1 and 3 years, respectively. The rate of late complications such as endoleaks or branch instability events was 12% (n = 30). The late branch occlusion rate during follow-up was 1.5% (n = 15), of which 12 were renal branches. CONCLUSIONS: EDE-iBEVARs demonstrate satisfactory medium-term outcomes with reintervention rates comparable to other endografts. Encouragingly, rates of branch patency were high, and major adverse events were low. This technology could expand the treatment options for patients with challenging complex aortic conditions.

A multicenter prospective observational study appraising the effectiveness of the Supera stent after subintimal recanalization of femoro-popliteal artery occlusion: The SUPERSUB II study.

BACKGROUND: Complex femoropopliteal artery disease represents a challenge. The Supera stent holds the promise of improving the results of endovascular therapy for complex femoropopliteal disease. AIMS: We aimed at appraising the early and long-term effectiveness of the Supera stent after successful subintimal angioplasty (SuperSUB strategy) for complex femoropopliteal lesions. METHODS: We conducted a multicenter, prospective, single-arm observational study including consecutive patients at participating centers in whom Supera was implanted after successful subintimal angioplasty for complex femoropopliteal lesions. RESULTS: A total of 92 patients were included Femoropopliteal arteries were the most common target, and lesion length was 261 ± 102 mm. Most procedures were technically demanding, with antegrade femoral access in 35 (38%) and retrograde distal access in 55 (60%). Supera stent length was 281 ± 111 mm, with 4, 5, and 6 mm devices being most commonly used: 32 (35%), 35 (38%), and 23 (25%), respectively. Technical success was achieved in 100% of subjects, as was clinical success (per subject), whereas procedural success (per subject) was obtained in 98%. At 24 months, freedom from clinically driven target lesion revascularization was 93%, whereas primary patency was 87%. When compared with a similar historical cohort, Supera stent use appeared to be associated with a reduction in resources. CONCLUSION: Use of Supera stent after successful subintimal recanalization of complex lower limb arterial lesions yields favorable procedural results, which are maintained over follow-up, and are associated also with a favorable resource use profile.

Rotational Mechanical Thrombectomy to Treat Iliac Limb Occlusion after Endovascular Aortic Aneurysm Repair: The Rotational Mechanical Thrombectomy Italian Study.

PURPOSE: To assess the safety and effectiveness of a rotational mechanical atherothrombectomy device in patients with symptomatic iliac limb occlusion after abdominal endovascular aneurysm repair (EVAR). MATERIALS AND METHODS: A retrospective analysis was conducted on patients who underwent rotational mechanical thrombectomy using the Rotarex S device for symptomatic acute, subacute, or chronic graft limb thrombosis at 5 vascular centers between 2017 and 2021. This study comprised 23 male patients with a mean age of 74.5 years (SD ± 7.2) at the time of the procedure. The clinical presentation of the patients varied, with 1 patient experiencing acute limb ischemia and 11 patients (47.8%) experiencing disabling intermittent claudication. The remaining patients developed chronic limb-threatening ischemia after iliac limb occlusion. Early outcomes included technical success, postprocedural complications, and periprocedural mortality. Follow-up evaluations encompassed primary patency, patient survival, freedom from reintervention, and the need for surgical conversion. RESULTS: Technical success was achieved in all cases, with no occurrences of distal embolization during or after the procedure, and no periprocedural deaths were reported. Endograft relining was performed in 82.6% of patients to establish a new, nonthrombogenic surface within the graft. Over a median follow-up period of 8 months (interquartile range, 3-16 months), 2 patients experienced iliac limb reocclusion. No deaths or other reinterventions occurred during the observational follow-up period. CONCLUSIONS: Rotational mechanical thrombectomy for iliac limb occlusion after EVAR appears to be both safe and effective. This technique may uncover intraluminal defects contributing to graft occlusion and enable their resolution within the same procedure.

Cost Analysis of Target Lesion Revascularisation in Patients With Femoropopliteal In Stent Re-Stenosis or Occlusion: The COSTLY-TLR Study.

OBJECTIVE: To report the cost of target lesion revascularisation procedures (TLR) for femoropopliteal peripheral artery disease (PAD) following stenting, from a healthcare payer's perspective. METHODS: European multicentre study involving consecutive patients requiring femoropopliteal TLR (January 2017 - December 2021). The primary outcome was overall cost (euros) associated with a TLR procedure from presentation to discharge. Exact costs per constituent, clinical characteristics, and early outcomes were reported. RESULTS: This study included 482 TLR procedures (retrospectively, 13 hospitals, six countries): 56% were female, mean age was 75 ± 2 years, 61% were Rutherford class 5 or 6, 67% had Tosaka class 3 disease, and 16% had common femoral or iliac involvement. A total of 52% were hybrid procedures and 6% involved open surgery only. Technical success was 70%, 30 day mortality rate was 1%, and the 30 day major amputation rate was 4%. Most costs were for operating time during the TLR (healthcare professionals' salaries, indirect and estate costs), with a mean of: €21 917 ± €2 110 for all procedures; €23 337 ± €8 920 for open procedures; €12 903 ± €3 108 for endovascular procedures; and €22 806 ± €3 977 for hybrid procedures. In a regression analysis, procedure duration was the main parameter associated with higher overall TLR costs (coefficient, 2.77; standard error, 0.88; p < .001). The mean cost per operating minute of TLR (indirect, estate costs, all salaried staff present included) was €177 and the mean cost per night stay in hospital (outside intensive care unit) was €356. The mean cost per overnight intensive care unit stay (minimum of 8 hours per night) was €1 193. CONCLUSION: The main driver of the considerable peri-procedure costs associated with femoropopliteal TLR was procedure time.

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.

Preliminary results from an Italian National Registry on the outcomes of the Najuta fenestrated aortic arch endograft.

BACKGROUND: Arch pathology represents one of the last frontiers in aortic aneurysm endovascular management. Several companies recently developed dedicated branched and fenestrated endografts specifically designed for the aortic arch, aiming to overcome some of the issues associated with standard thoracic endograft and supra-aortic vessels extra-anatomic debranching. This study aimed to evaluate early outcomes obtained with a custom-made fenestrated endograft approved for thoracic aortic aneurysms exclusion. METHODS: All consecutive patients treated with the Najuta endograft (Kawasumi Laboratories, Inc, Tokyo, Japan) in Italy were enrolled prospectively and included in the study population. Anatomic characteristics and perioperative data were analyzed retrospectively. Study end points were technical success, 30-day clinical success, overall survival, supra-aortic vessel patency, endoleak, and need for reintervention or surgical conversion. RESULTS: Between 2018 and 2022, 76 patients received a Najuta endograft in Italy and were enrolled in the study. The median patient age was 72 years (interquartile range, 69-76 years) and 80.3% were male. Most of the patients received treatment for atherosclerotic aneurysms (80.3%); others were treated for postdissection aneurysms (7.9%), penetrating aortic ulcer (9.2%), or type I endoleak correction after previous thoracic endovascular repair (2.6%). Overall, 161 supra-aortic vessels were preserved through a dedicated fenestration. Technical success was achieved in 74 of 76 procedure (97.4%); both failures were associated with endoleak detection at final angiography (one type I and one type III endoleak). Two distal migrations occurred during the implanting procedure. Clinical success at 30 days was 94.7%. Two early reinterventions were needed within 30 days after index procedure: in one case, an aortic false lumen coils embolization was performed, because distal re-entry caused enlargement of the postdissection thoracic aneurysm. The other procedure consisted of a femoral pseudoaneurysm repair. The median follow-up was 7 months (interquartile range, 3-15 months); no supra-aortic vessel occlusions occurred and no patients needed surgical conversion. CONCLUSIONS: Early results suggest that, in selected patients with aortic arch pathology needing a proximal landing, an endovascular approach with the Najuta system is safe and effective, especially for those at high surgical risk. A strict follow-up with high-quality computed tomography angiography images and eventual evaluation for long-term complications is needed to confirm these initial experience findings.

Analysis of predisposing factors for type III endoleaks from directional branches after branched endovascular repair for thoracoabdominal aortic aneurysms.

BACKGROUND: Mid-term durability of branches has already been established, and BF-branched and fenestrated endovascular repair has shown comparable results with open repair in the treatment of thoracoabdominal aortic aneurysms (TAAAs). Nevertheless, target vessel instability remains the most frequent adverse event after complex endovascular aortic repair. Type III endoleaks from directional branches have been reported with a low incidence, but risk factors for this complication have not been investigated yet. METHODS: This was a dual-center observational retrospective cohort study. Data were collected prospectively for each patient treated with branched endovascular repair between April 2008 and December 2019. The primary outcome was to assess potential risk factors for branch disconnection and fracture. A logistic regression analysis was performed, including preoperative and postoperative measurements as well as intraoperative details. A Cox regression hazard analysis was performed to evaluate the influence of preoperative aneurysm diameter and target vessel angulation on the outcome during follow-up. RESULTS: Two hundred ninety-five target visceral vessels (TVVs) in 91 patients were considered suitable for cannulation. Technical success was 96.9% (286/295 TVVs). The median follow-up was 32.5 months (interquartile range, 14.2-50.1 months). Twelve type III endoleaks from directional branches were detected (4.2%; 5 bridging stent graft fractures and 7 disconnections). Five type III endoleaks involved the celiac trunk (one fracture and four disconnections), five the superior mesenteric artery (four fractures and one disconnection), and two the renal arteries (both disconnections). The median time to type III endoleak was 22.2 months (interquartile range, 10.9-37.6 months). Preoperative TAAA diameter (P = .028), preoperative TVV angulation (P = .037), the use of a BeGraft stent graft as bridging stent graft (P = .001), and different stent types on the same vessel (P = .048) were associated with type III endoleak at univariable analysis. Using a BeGraft stent graft (P = .010) was the only significant factor predisposing to type III endoleak at multiple logistic regression. The Cox regression analysis showed a two-fold increased risk for type III endoleak for every 10-mm increase in preoperative TAAA diameter (hazard ratio, 2.00; 95% confidence interval, 1.08-3.72; P = .028) and a 1.5 increased risk every 12° increase of preoperative TVV angulation (hazard ratio, 1.47; 95% confidence interval, 1.02-2.10; P = .037). CONCLUSIONS: Type III endoleaks from directional branches are a non-negligible complication after branched endovascular repair, with a relevant incidence. They tended to be clustered on specific patients, and aneurysm diameter and TVV angulation are strictly associated with the outcome. Different stent types on the same vessel should be avoided whenever possible. An intensified follow-up should be adopted for patients with large aneurysms, implanted with first-generation BeGraft, or who have been already diagnosed with type III endoleaks.

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

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

Midterm results on a new self-expandable covered stent combined with branched stent grafts: Insights from a multicenter Italian registry.

OBJECTIVE: To investigate the technical periprocedural and midterm outcomes of endovascular repairs with multibranched endovascular repair or iliac branch devices combined with a new self-expanding covered stent. METHODS: The COvera in BRAnch registry is a physician-initiated, multicenter, ambispective, observational registry (ClinicalTrials.gov Identifier: NCT04598802) enrolling patients receiving a multibranched endovascular repair or iliac branch devices procedure mated with Bard Covera Plus (Tempe, AZ) covered stent, designed to evaluate the outcomes of the covered stent mated with patient-specific and off-the-shelf branched stent graft. Primary end points were technical success, branch instability, and freedom from aortic and branch-related reintervention within 30 days and at follow-up. Preoperative characteristics, comorbidities, and outcomes definitions were graded according to the Society for Vascular Surgery reporting standards. RESULTS: Two hundred eighty-four patients (76 years; range, 70-80 years; 79% males) in 24 centers were enrolled for a total of 708 target vessels treated. The covered stents were mated with an off-the-shelf graft in 556 vessels (79%) and a custom-made graft in 152 (21%). Three hundred seven adjunctive relining stents in 277 vessels (39%) were deployed, of which 116 (38%) were proximal, 66 (21%) intrastent, and 125 (41%) distal. Adjunctive relining stent placement was more frequent when landing in a vessel branch instead of the main trunk (59% vs 39%; P = .031), performing a percutaneous access (49% vs 35%; P < .001), using a stent with a diameter of 8 mm or greater (44% vs 36%; P = .032) and a length of 80 mm or greater (65% vs 55%; P = .005), when a post-dilatation was not performed (45% vs 29%; P < .001) and when an inner branch configuration was used (55% vs 35%; P < .001). Perioperative technical bridging success was 98%. Eight patients (3%) died in the perioperative period. Two deaths (1%) were associated with renal branch occlusion followed by acute kidney injury and paraplegia. Follow-up data were available for 638 vessels (90%) at a median of 32 months (Q1, Q3, 21, 46). Branch instability was reported in 1% of branches. Forty-six patients (17%) died during follow-up, nine (3%) of them owing to aortic-related causes. Primary patency rates at 1, 2, and 3 years were 99% (581/587), 99% (404/411), and 97% (272/279), respectively. Branch instability was associated with patient-specific devices (9% vs 4%; P = .014) and intrastent adjunctive stent placement (12% vs 2%; P = .003), especially when a bare metal balloon-expandable stent was used (25% vs 3%; P < .001). CONCLUSIONS: The use of this new self-expanding covered stent mated with branched endografts proved to be safe and feasible with high technical procedural success rates. Low rates of branch instability were observed at midterm follow-up. Comparative studies with other commercially available covered stents are warranted.

Results of iliac branch devices for hypogastric salvage after previous aortic repair.

OBJECTIVE: The aim of this multicentric study was to assess the "REsults of iliac branch deviceS for hypogastriC salvage after previoUs aortic rEpair (RESCUE)." METHODS: All consecutive patients who underwent implantation of iliac branch devices (IBDs) after previous open aortic repair (OAR) or endovascular aortic repair (EVAR) at seven centers were captured. The study cohort was divided into two groups according to the type of repair originally performed. Early outcomes included immediate technical success and perioperative adverse events. Late outcomes included survival, side branch (SB) primary patency, SB instability, and new onset buttock claudication. RESULTS: A total of 94 patients (82 male) were included in the study, 10 of them received bilateral implantation of IBDs. This resulted in a total of 104 devices included in the final analysis. Indication for treatment were endoleak 1b or progressive iliac aneurysmal degeneration or distal para-anastomotic aortic aneurysms; 73 were implanted after previous EVAR and 31 after previous OAR. Technical success was 100% in both groups. The 3-year rate of freedom from SB instability was 90.1% after previous EVAR and 85.4% after previous OAR, respectively (P = .05). The 3-year estimates of SB primary patency were significantly lower in patients who had received OAR as compared with those that had received EVAR (89.8% vs 94.9%; P = .05). CONCLUSIONS: Endovascular treatment with IBDs following previous OAR or EVAR is safe and effective up to 3 years. Freedom from SB instability during follow-up was lower in patients who had previously undergone OAR than EVAR.

Bypass vs endovascular treatment for occluded femoro-popliteal stents in patients with critical limb-threatening ischemia.

OBJECTIVE: The aim of the study was to compare the early and medium-term outcomes of bypass vs endovascular treatment of occluded femoro-popliteal stents in patients with chronic limb-threatening ischemia (the OUT-STEPP multicentric registry). METHODS: Between January 2016 and December 2021, 317 patients in 14 centers underwent treatment for a symptomatic occlusion of femoro-popliteal stent/stents. One hundred sixty-one patients were included into the present study: 46 (28.6%) underwent open bypass surgery (Group OPEN), and 115 (71.4%) underwent endovascular revascularization (Group ENDO). Early (30 days) results were assessed and compared between the two groups. Estimated 5-year outcomes were evaluated and compared with the log rank test. RESULTS: At 30 days, no differences were found in terms of major adverse cardiovascular events, acute kidney injury, reinterventions, major amputation, and all-cause mortality between the two groups. The need for blood transfusions was higher for patients in Group OPEN (17; 36.9% vs 13; 11.3%; P < .001). The mean length of intensive care unit stay and the mean hospital stay were higher for patients in Group OPEN ([0.3 ± 0.9 vs 0 days; P < .001] and [9.7 ± 5.8 vs 3.3 ± 1.4 days; P < .001], respectively). The overall median duration of follow-up was 33.1 months (interquartile range, 14-49.5 months). At 5 years, there were no differences between the two groups in terms of survival (68.7% Group OPEN vs 68.8% Group ENDO; P = .27; log-rank, 1.21), primary patency (56.3% Group OPEN vs 67.8% Group ENDO; P = .39; log-rank, 0.75), secondary patency (59.1% Group OPEN vs 77.8% Group ENDO; P = .24; log-rank, 1.40), absence of target lesion restenosis (56.8% Group OPEN vs 62.7% Group ENDO; P = .42; log-rank, 0.65), and limb salvage (77.2% Group OPEN vs 90.4% Group ENDO; P = .17; log-rank, 1.87). CONCLUSIONS: Both bypass and endovascular treatment provided safe and effective restoration of patency for femoro-popliteal in-stent occlusion in patients with chronic limb-threatening ischemia. Open surgery was associated with longer stay in hospital and increased use of blood transfusions. At 5 years, no significant differences were found in the rates of overall patency or limb salvage between bypass and endovascular treatment.

Fate of target visceral vessels in fenestrated and branched complex endovascular aortic repair.

OBJECTIVE: To assess branch vessel outcomes after endovascular repair of complex aortic aneurysms analyzing possible factors influencing early and long-term results. METHODS: The Italian Multicentre Fenestrated and Branched registry enrolled 596 consecutive patients treated with fenestrated and branched endografts for complex aortic disease from January 2008 to December 2019 by four Italian academic centers. The primary end points of the study were technical success (defined as target visceral vessel [TVV] patency and absence of bridging device-related endoleak at final intraoperative control), and freedom from TVV instability (defined as the combined results of type IC/IIIC endoleaks and patency loss) during follow-up. Secondary end points were overall survival and TVV-related reinterventions. RESULTS: We excluded 591 patients (3 patients with a surgical debranching and 2 patients who died before completion from the study cohort) were treated for a total of 1991 visceral vessels targeted by either a directional branch or a fenestration. The overall technical success rate was 98.4%. Failure was related to the use of an off-the-shelf (OTS) device (custom-made device vs OTS, HR, 0.220; P = .007) and a preoperative TVV stenosis of >50% (HR, 12.460; P < .001). The mean follow-up time was 25.1 months (interquartile range, 3-39 months). The overall estimated survival rates were 87%, 77.4%, and 67.8% at 1, 3, and 5 years, respectively (standard error [SE], 0.015, 0.022, and 0.032). During follow-up, TVV branch instability was observed in 91 vessels (5%): 48 type IC/IIIC endoleaks (2.6%) and 43 stenoses-thromboses (2.4%). The extent of aneurysm disease (thoracoabdominal aortic aneurysm [TAAA] types I-III vs TAAA type IV/juxtarenal aortic aneurysm/pararenal aortic aneurysm) was the only independent predictor for developing a TVV-related type IC/IIIC endoleak (HR, 3.899; 95% confidence interval [CI]:, 1.924-7.900; P < .001). Risk of patency loss was independently associated with branch configuration (HR, 8.883; P < .001; 95% CI, 3.750-21.043) and renal arteries (HR, 2.848; P = .030; 95% CI, 1.108-7.319). Estimated rates at 1, 3, and 5 years of freedom from TVV instability and freedom from TVV-related reintervention were 96.6%, 93.8%, and 90% (SE, 0.005, 0.007, and 0.014) and 97.4%, 95.0%, and 91.6% (SE, 0.004, 0.007, and 0.013), respectively. CONCLUSIONS: Intraoperative failure to bridge a TVV was associated with a preoperative TVV stenosis of >50% and the use of OTS devices. Midterm outcomes were satisfying, with an estimated 5-year freedom from TVV instability and reintervention of 90.0% and 91.6%, respectively. During follow-up, the larger extent of aneurysm disease was associated with an increased risk of TVV-related endoleaks, whereas a branch configuration and renal arteries were more prone to patency loss.

Transatlantic multicenter study on the use of a modified preloaded delivery system for fenestrated endovascular aortic repair.

OBJECTIVE: Analyze the outcomes of endovascular complex abdominal and thoracoabdominal aortic aneurysm repair using the Cook fenestrated device with the modified preloaded delivery system (MPDS) with a biport handle and preloaded catheters. METHODS: A multicenter retrospective single arm cohort study was performed, including all consecutive patients with complex abdominal aortic aneurysm repair and thoracoabdominal aortic aneurysms treated with the MPDS fenestrated device (Cook Medical). Patient clinical characteristics, anatomy, and indications for device use were collected. Outcomes, classified according to the Society for Vascular Surgery reporting standards, were collected at discharge, 30 days, 6 months, and annually thereafter. RESULTS: Overall, 712 patients (median age, 73 years; interquartile range [IQR], 68-78 years; 83% male) from 16 centers in Europe and the United States treated electively were included: 35.4% (n = 252) presented with thoracoabdominal aortic aneurysms and 64.6% (n = 460) with complex abdominal aortic aneurysm repair. Overall, 2755 target vessels were included (mean ,3.9 per patient). Of these, 1628 were incorporated via ipsilateral preloads using the MPDS (1440 accessed from the biport handle and 188 from above). The mean size of the contralateral femoral sheath during target vessel catheterization was 15F ± 4, and in 41 patients (6.7%) the sheath size was ≤8F. Technical success was 96.1%. Median procedural time was 209 minutes (IQR, 161-270 minutes), contrast volume was 100 mL (IQR, 70-150mL), fluoroscopy time was 63.9 minutes (IQR, 49.7-80.4 minutes) and median cumulative air kerma radiation dose was 2630 mGy (IQR, 838-5251 mGy). Thirty-day mortality was 4.8% (n = 34). Access complications occurred in 6.8% (n = 48) and 30-day reintervention in 7% (n = 50; 18 branch related). Follow-up of >30 days was available for 628 patients (88%), with a median follow-up of 19 months (IQR, 8-39 months). Branch-related endoleaks (type Ic/IIIc) were observed in 15 patients (2.6%) and aneurysm growth of >5 mm was observed in 54 (9.5%). Freedom from reintervention at 12 and 24 months was 87.1% (standard error [SE],1.5%) and 79.2% (SE, 2.0%), respectively. Overall target vessel patency at 12 and 24 months was 98.6% (SE, 0.3%) and 96.8% (SE, 0.4%), respectively, and was 97.9% (SE, 0.4%) and 95.3% (SE, 0.8%) for arteries stented from below using the MPDS, respectively. CONCLUSIONS: The MPDS is safe and effective. Overall benefits include a decrease in contralateral sheath size in the treatment of complex anatomies with favorable results.

The Semibranch: A New Tool for Complex Aortic Pathologies.

PURPOSE: To describe the semibranch as new tool to treat patients with thoracoabdominal, para- and juxtarenal aortic pathologies. TECHNIQUE: The technique is demonstrated in 2 patients with aortic pathologies. First, a 76-year-old woman with a type Ia endoleak after endovascular repair of abdominal aneurysm (EVAR). Due to the short mainbody of the EVAR and suprarenal extension of the pathology, a 4-branched device with integrated bifurcation was chosen. To realize a branched device in small diameters of the suprarenal aorta, 2 semibranches, for the superior mesenteric artery (SMA) and the celiac trunc (CT), were planned. The second patient, a 75-year-old man, had a juxtarenal aneurysm. Due to small diameters of the aorta, semibranches for the SMA and the CT were planned. In both cases, a total transfemoral approach was used with a steerable sheath. Placement, cannulation of the semibranch, forwarding of the bridging stentgraft, and sealing was uneventful. All 4 semibranches were successful in sealing the aneurysm. CONCLUSION: The semibranch is another tool in the armamentarium of the endovascular interventionalist, which can expand the range of patients that can be treated. Especially patients with small aortic diameter or short distances between target vessels with the same offspring angle can profit from the semibranch design. CLINICAL IMPACT: The semibranch is a new tool to treat thoracoabdominal as well para- and juxtarenal aortic pathologies. Due to its reduced length, packaging density can be higher and diameter of the stentgraft can be larger. It closes the gap in pathologies where fenestration are not suitable (kinked aortas) and there is not enough space for standard inner branches (small diameters).

Effectiveness of the Rotarex Excisional Atherectomy System in Both Subacute and Chronic Aortoiliac Endograft Thrombosis: An Innovative Option for the Modern Endovascular Surgeon Toolkit.

PURPOSE: To report a successful revascularization case using the Rotarex™S atherothrombectomy system in a recent iliac limb thrombosis, and chronic hypogastric stent obstruction after previous aortoiliac aneurysm endovascular repair (EVAR). CASE REPORT: A 72-year-old patient was treated for recent right iliac limb thrombosis and left iliac branch chronic hypogastric stent occlusion, 5 years after EVAR. A total endovascular approach, using both upper extremity and femoral vascular access, was settled with 2 Rotarex™S (6Fr and 10Fr) devices. The Rotarex™S catheters removed most of the intraluminal material, allowing additional endografts and bare metal stents to be deployed to support a new healthy lumen surface. CONCLUSION: The total endovascular approach provided by the Rotarex™S device appears to be safe and effective in treating aortoiliac endografts occlusions, both in subacute and chronic phases. Larger studies could highlight differences and eventual advantages compared with more traditional solutions.

Iliac Branch Devices in the Repair of Ruptured Aorto-iliac Aneurysms: A Multicenter Study.

PURPOSE: To evaluate the outcomes of preserving the internal iliac artery (IIA) with iliac branched devices (IBDs) during acute endovascular repair of ruptured aortoiliac aneurysms. MATERIAL AND METHODS: This is a multicenter retrospective review of all consecutive patients undergoing acute endovascular repair of ruptured aortoiliac aneurysm with an IBD at 8 aortic centers between December 2012 and June 2020. A control group was used where the IIA was intentionally occluded from the same study period. The main outcome measures were 30-day mortality, major adverse events, technical success, and clinical success. Secondary outcomes were buttock claudication, primary patency, primary-assisted and secondary patency of the IBD, occurrence of endoleak types I/III, and reintervention. Values are presented as numbers and percentages or interquartile range in parenthesis. RESULTS: Forty-eight patients were included in the study: 24 with IBD and 24 with IIA occlusion. There was no difference in demographics, cardiovascular risk factors, and aneurysm extent. Twenty (83%) of them were hemodynamically stable during the procedure as opposed to 14 (58%, p=.23) with the IIA occlusion. Technical success was achieved in all cases with a procedure time of 180 (133-254) minutes, 45 (23-65) of which were from IBD. There were 2 (8%) deaths during the first 30 days and 2 (8%) major complications unrelated to the IBD, whereas in the IIA occlusion, the figures were 10 (42%) and 7 (29%), respectively. No patient in the IBD group developed buttock claudication compared to 8 (57%, p<.0001) in the IIA occlusion group; 1 (4%) patient developed bowel ischemia on both groups, with 1 in the IIA occlusion group needing resection. The median follow-up duration was 17 months (interquartile range 2-39) for the IBD group, with a primary patency of 60±14% at 3 years that went up to 92±8% with reinterventions (8 reinterventions in 6 patients). When the first 90 days were disregarded, there were no differences in survival between the groups. CONCLUSION: IBD is a valid alternative for maintaining the pelvic circulation for endovascular aortic aneurysm repair of ruptured aortoiliac aneurysms. The technical success and midterm outcomes are very satisfactory but require patient selection particularly regarding hemodynamic stability. The reintervention rate is considerable, mandating continuous follow-up. CLINICAL IMPACT: This multicenter study demonstrates that ruptured aortoiliac aneurysms do not necessarily require mandatory occlusion of hypogastric arteries. Iliac branch devices are shown to be a valid alternative in highly selected cases, with good midterm results, even if reinterventions are required in a significant proportion of patients.

Spinal Cord Ischemia After Thoracoabdominal Aortic Aneurysms Endovascular Repair: From the Italian Multicenter Fenestrated/Branched Endovascular Aneurysm Repair Registry.

PURPOSE: The aim of this study is to report an Italian multicenter experience analyzing the incidence and the risk factors associated with spinal cord ischemia (SCI) in a large cohort of thoracoabdominal aortic aneurysms (TAAAs) treated by fenestrated-branched endovascular aneurysm repair (F-/B-EVAR). MATERIALS AND METHODS: All consecutive patients undergoing F-/B-EVAR in 4 Italian university centers between 2008 and 2019 were prospectively recorded and retrospectively analyzed. Spinal cord ischemia, 30 day/in-hospital adverse events, and mortality were assessed as early outcomes. Risk factors for SCI were determined by multivariable analysis. RESULTS: A total of 351 patients received F-/B-EVAR for a TAAA. Twenty-eight (8.0%) patients died within 30 postoperative days or during the hospitalization. Regarding SCI, 47 patients (13.4%) developed neurological symptoms related to spinal cord impaired perfusion. Among them, 17 (4.8%) had a major permanent impairment. The multivariable analysis identified that SCI was associated with Crawford extent I to III (odds ratio [OR]: 20.90, p=0.004, 95% confidence interval [CI]=2.69-162.57), and with endovascular procedures performed for ruptured TAAA (OR: 5.74, p=0.010, 95% CI=1.53-21.57). Spinal cord ischemia was also significantly associated with a grade 3 bleeding during the visceral stage (OR: 4.34, p=0.005, 95% CI=1.55-12.16) and a grade 2 renal insufficiency at 30 days (OR: 7.45, p=0.002, 95% CI=2.12-26.18). CONCLUSION: The present study indicates that SCI is still an open issue after extent I to III TAAA endovascular repair, while its incidence in extent IV TAAA and pararenal/juxtarenal aneurysms is rare. Thoracoabdominal aortic aneurysms extension, urgent TAAA repair for rupture, severe bleeding, and 30 day renal insufficiency have been identified as significant risk factors for SCI. In the presence of such factors, adjunctive strategies may be considered to reduce SCI rates, while in low-risk patients invasive or potentially-risky maneuvers might not be justified.

Endovascular Versus Surgical Treatment for All Comer Patients With Prosthetic Bypass Graft Occlusion: The Multicentre ENSUPRO Study.

OBJECTIVE: Bypass surgery plays a key role in complex lower limb lesions. However, there is a lack of evidence regarding the management of symptomatic prosthetic bypass graft (PBG) occlusion. This study aimed to report outcomes following open, hybrid, or endovascular management of patients presenting with symptomatic PBG occlusion. METHODS: A multicentre, retrospective cohort study was conducted, including patients presenting with PBG occlusion between January 2014 and December 2021 from 18 centres. It assessed the comparative value of treatment strategies, including (1) recanalisation of native vessels, (2) endovascular treatment of the failed PBG, (3) hybrid treatment, and (4) open surgery. The primary outcome measure was amputation free survival (AFS, time to major amputation and or death), whereas all cause mortality, major amputation, PBG re-occlusion, target lesion revascularisation (TLR), and Rutherford category (RC) improvement during follow up were considered as secondary endpoints. RESULTS: Of 260 patients with occluded PBGs, 108 (41.5%) were treated endovascularly (24 [22.2%] by recanalisation of native vessels and 84 [77.7%] by PBG re-opening), 57 (21.9%) underwent hybrid revascularisation, and 58 (22.3%) had surgery. In addition, 27 (10.4%) were treated conservatively and 10 (3.8%) received systemic thrombolysis. With a median follow up of 1.4 (0.6 - 3.0) years, AFS was 95.5%, 76.4%, 45.5%, and 37.1%, respectively in Groups 1 - 4 (p = .007). Older age and non-endovascular treatment (HR 1.05 and 1.70; p < .01 for both) were independent predictors of poor AFS. Endovascular treatment was associated with lower rates of major amputation (p = .04), PBG re-occlusion (p < .001), and TLR (p = .037), and higher RC improvements (p < .001), whereas all cause mortality was comparable between treatment groups (p = .21). CONCLUSION: Endovascular treatment is associated with higher rates of AFS and RC improvement and lower rates of PBG re-occlusion and TLR in patients with PBG occlusion.

Penumbra Indigo Percutaneous Aspiration Thrombectomy System in the treatment of Aortic Endograft Iliac Limb Occlusion: Results from an Italian Multicentre Registry.

OBJECTIVE: This study aimed to evaluate the safety and effectiveness of the Penumbra Indigo percutaneous aspiration thrombectomy (PAT) system in the clinical presentation of iliac limb occlusion (ILO) after endovascular aortic repair (EVAR). METHODS: A retrospective, observational, multicentre study conducted in eight Italian vascular centres. Consecutive patients presenting with ILO after EVAR were eligible. To assess vessel revascularisation, Thrombo-aspiration In Peripheral Ischaemia (TIPI) classification (score 0-3) was used at presentation (t1), after PAT (t2), and after adjunctive procedures (t3). Successful revascularisation was considered TIPI 2-3 (near complete or complete). Primary intra-operative outcomes were technical success (TS) of Indigo PAT and combined TS of PAT associated with adjunctive procedures when needed. Primary follow up outcomes were safety and effectiveness at one, six, and 12 months. RESULTS: From September 2019 to December 2021, there were 48 ILO and 17 patients (35%) [median age 75 years, IQR 71, 83 years; male, 14 (82%); urgent, 8 (47%)] were treated and enrolled. The median time after primary EVAR was 24 months (IQR 0, 42 months). The median clot age from ILO diagnosis to PAT was three days (IQR 1, 12 days). Ten patients (59%) presented with limb threatening ischaemia. At t1, TIPI 0 and 1 was present in 13 (76%) and four (24%) cases, respectively. At t2, primary TS (TIPI 2-3) was achieved in 14 cases (82%) after Indigo PAT (p < .001). Fifteen patients (88%) required adjunctive procedures (14 re-linings, one surgical patch angioplasty). At t3, combined TS was achieved in 16 cases (94%). Intra-operative complication included one (6%) distal embolisation, treated successfully. The 30 day mortality was one case (6%) due to pneumonia. At one, six, and 12 months, clinical success was 100% without ILO recurrence. The median follow up was 23 months (IQR 11, 41 months): at 18 months, survival and freedom from re-intervention were 91 ± 8% and 90 ± 9%, respectively. CONCLUSION: This study reports for the first time the efficacy and safety of Penumbra Indigo PAT for ILO after EVAR, with promising technical and clinical success up to one year.

Role of historical and procedural staging during elective fenestrated and branched endovascular treatment of extensive thoracoabdominal aortic aneurysms.

OBJECTIVE: Procedural staging is often performed to reduce the incidence of spinal cord ischemia (SCI) during endovascular treatment of extensive thoracoabdominal aortic aneurysms (TAAAs). However, its role in the case of previous thoracic or infrarenal aortic repair (historical staging) has been controversial. In the present study, we evaluated the SCI rates when procedural staging was routinely used and studied its potential benefits when previous aortic repairs had already been performed. METHODS: The data from patients treated electively with fenestrated/branched endovascular aortic repair for extent I, II, III, and V TAAAs were retrieved from a multicenter registry (four high-volume national teaching hospitals) and analyzed. The primary endpoint was the rate of SCI and its association with preoperative and postoperative variables, including historical staging, procedural staging, and an impaired collateral network (subclavian or hypogastric stenosis >75% per occlusion). Variables were defined in accordance with the Society for Vascular Surgery reporting standards. A logistic regression model with stepwise selection was used to identify the predictors of SCI. RESULTS: A total of 240 patients (76% male; median age, 73 years) were analyzed. Of the 240 patients, 43 (18%) had presented with an impaired collateral network, 136 (57%) had had historical staging, and 157 (65%) had received procedural staging. Preoperative spinal fluid cerebrospinal drainage was performed in 130 patients (54%). Permanent grade 3 SCI was observed in 13 patients (5%) and was negatively affected by both an impaired collateral network (odds ratio [OR], 17.3; 95% confidence interval [CI], 1.7-176; P = .016) and the presence of bilateral iliac occlusive disease (OR, 10.1; 95% CI, 1.1-98.3; P = .046). Both historical (OR, 0.02; 95% CI, 0.001-0.46; P = .014) and procedural (OR, 0.01; 95% CI, 0.02-0.7; P = .019) staging mitigated the permanent SCI rates. The need for postoperative transfusions (OR, 1.4; 95% CI, 1.1-1.8; P = .014) and the occurrence of postoperative renal complications (OR, 6.5; 95% CI, 1.2-35.0; P < .001) were associated with the development of SCI. Among the patients with historical staging, no further benefit from procedural staging was observed (SCI with procedural staging, 1%; vs no staging, 2%; P = NS). CONCLUSIONS: For patients with extensive TAAAs treated with fenestrated/branched endovascular aortic repair, both historical and planned procedural staging were associated with reduced permanent SCI rates. However, no additional benefit was observed when procedural staging was performed in patients with historical staging and an intact collateral network. The protective role of preoperative cerebrospinal fluid drainage placement requires further investigation.