Outcomes of Off the Shelf Outer Branched Versus Inner Branched Endografts in the Treatment of Thoraco-Abdominal Aortic Aneurysm in the B.R.I.O. (BRanched Inner - Outer) Study Group.

OBJECTIVE: This study aimed to compare two commercially available off the shelf branched endografts for thoraco-abdominal aortic aneurysm (TAAA) repair, namely the E-nside (Artivion) and Zenith t-Branch (Cook Medical) devices. METHODS: This multicentre retrospective study (2020 - 2023) included patients treated by branched endovascular aortic repair (BEVAR) for TAAA using the inner branched E-nside or the outer branched t-Branch. Endpoints were 30 day technical success and major adverse events (MAEs) as well as one year freedom from target vessel instability and main endograft instability. RESULTS: The study included 163 patients: 79 (307 target vessels) treated with E-nside and 84 (325 target vessels) with t-branch. Aneurysm extent was I - III in 91 patients (55.8%; 47% of E-nside and 66% of t-Branch) and IV in 72 patients (44.2%; 53% of E-nside and 34% of t-Branch) (p = .011). An adjunctive proximal thoracic endograft was used in 43% of E-nside vs. 69% of t-Branch (p < .001), with less frequent thoracic endografting (14% vs. 76%; p < .001) and shorter length of coverage (p = .024) in extent IV TAAA treated by E-nside. E-nside cases had shorter renal artery bridging lengths (66 ± 17 mm vs. 76 ± 20 mm; p < .010) and less frequent use of a distal bifurcated endograft (53% vs. 80%; p < .001). Comparing 30 day results, the mortality rate was 1% vs. 2% (p = .62), any MAE occurred in 18% vs. 21% (p = .55), the stroke rate was 3% vs. 0% (p = .23), and the elective spinal cord ischaemia rate was 5% vs. 8% (p = .40) for E-nside and t-Branch, respectively. At one year, freedom from target vessel instability was 96 ± 3% for E-nside and 95 ± 3% for t-Branch (p = .58), and freedom from endograft instability was 98 ± 2% vs. 97 ± 3% (p = .46), respectively. CONCLUSION: Both off the shelf devices provided excellent early and one year results. The E-nside may require shorter thoracic aortic coverage and bridging length for the renal arteries, and less frequent implantation of a concomitant proximal thoracic or distal abdominal bifurcated endograft. However, these aspects did not determine significant differences in clinical outcomes.

Aneurysmal artery supplying pulmonary sequestration: successful combined approach.

A 62-year-old man was diagnosed with an asymptomatic intralobar pulmonary sequestration supplied by a short-neck proximal 57×25 mm aneurysmal artery originating from the mid-descending aorta. The patient underwent thoracic endovascular aneurysm repair; an aortic endograft was released to entirely restore the aberrant vessel. Then, pulmonary resection was performed. A triportal video-assisted left lower lobectomy was carried out. The thoracic endovascular aneurysm repair minimized the risk of bleeding and allowed a safe pulmonary resection with a minimally invasive approach.

EXTENT study: 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.

Comparison of bridging stent grafts in branched endovascular aortic repair.

BACKGROUND: Endovascular treatment of thoracoabdominal aortic aneurysms has become common, with satisfactory results. Nevertheless, long-term durability remains an issue mainly because of target visceral vessel (TVV) instability. Currently, no covered stent has been approved as a bridging stent graft (BSG), demanding continuous research on this topic. METHODS: This was a multicenter observational retrospective cohort study comparing the midterm results of the Bard Covera Plus and Gore VBX as BSGs during branched endovascular aneurysm repair. The primary outcome was the comparison of the target vessel instability between the two groups. Primary patency, freedom from branch-related type I and III endoleaks and reintervention, and technical and clinical success were considered secondary outcomes. Logistic regression analysis was used to assess the association between selected baseline factors and TVV instability. TVV instability during follow-up was then evaluated using the Kaplan-Meier cumulative function. RESULTS: Three hundred forty-five TVVs in 106 patients were considered suitable for the analysis. Two hundred twenty vessels were stented with the Covera stent graft (64%) and 125 with VBX (36%). Two hundred ninety-nine TVVs received a single BSG, 45 two BSGs, and only 1 three BSGs. Bare metal stent relining was required in 36% of TVVs, mostly in the Covera group (89 [41%] vs 36 [29%]) (P = .030). The primary technical success rate was 96% (331/345), and the assisted primary technical success rate was 99% (342/345). The TVV instability rate within 30 days was 2% (one Covera and five VBX; P = .015). Three BSG occlusions (one Covera and two VBX) and three type Ic endoleaks (three VBX) were detected. The median follow-up was 13.9 months (range, 5.8-25.5 months). Sixteen TVV instabilities were detected during the follow-up. Twelve BSG occlusions (six Covera and six VBX), three type Ic endoleaks (one Covera and two VBX), and one type IIIc endoleak (VBX). The overall target vessel instability rate was 5% (16/342). TVV instability was associated with the use of Gore VBX in the univariable logistic regression (odds ratio, 3.0; 95% confidence interval, 1.1-8.0; P = .027). Aneurysm rupture and aneurysm diameter were also associated with TVV instability in the univariable analysis (P = .002 and P = .008, respectively). The only factor predisposing to TVV instability in the multivariable logistic regression analysis was the use of Gore VBX as a BSG (odds ratio, 2.9; 95% confidence interval, 1.0-8.0; P = .043). Kaplan-Meier analysis showed a significantly higher risk of TVV instability in the VBX group (P < .001). CONCLUSIONS: Overall midterm outcomes in this cohort were satisfactory. Patency rates were similar between the two stents. Nevertheless, VBX seems to be associated with worse TVV instability. These results may be correlated with a higher incidence of type Ic endoleaks, which require an extensive learning curve for correct stent selection and deployment.

Off-label use of the Gore Excluder iliac branch endoprosthesis in association with the Rotarex S catheter to achieve total endovascular recanalization of an occluded aortobifemoral bypass.

We describe a successful case of hybrid revascularization of a totally occluded aortobifemoral bypass with retrograde use of the Rotarex S catheter (BD) and complete relining with a Gore Excluder iliac branch endoprosthesis (W.L. Gore & Associates). The repair procedure was performed with femoral surgical access and percutaneous brachial access. Despite left renal artery endoclamping, after the final angiography, deployment of a covered stent in the left renal artery was needed because of residual thrombotic material at the vessel ostium. The procedure was completed with reconstruction using a common femoral artery Dacron graft and bilateral complete iliac surgical branch relining using self-expanding covered stents, with recovery of distal pulses.

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.

Acute perioperative complications after arterial and venous femoral access in major vascular and cardiac procedures: Ischemic or hemorrhagic patterns and how to solve them.

A direct percutaneous arterial and venous approach to the common femoral vessel has become the first option in most large-bore percutaneous vascular and cardiac procedures, making the issue of access site-related complications (ASCs) a pressing clinical concern. ASCs represent a potentially limb-threating and/or life-threatening scenario that alters the clinical success of the procedure and contributes to increased length of stay and resource utilization. Preoperative assessment of risk factors for ASCs should be well known before planning an endovascular percutaneous procedure and early diagnosis is necessary for prompt treatment. Several percutaneous and surgical approaches have been reported in case of ASCs, according to the different etiologies of these complications. The aim of this review was to report the incidence of ASCs in vascular and cardiac large-bore procedures, diagnosis, and available treatments according to the latest available literature.

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.

Endovascular thrombectomy devices for acute limb ischemia management.

Acute limb ischemia still represents a challenge for the contemporary vascular surgeon, representing an immediate threat for patients' limb but potentially also for the proper patient life in some settings. Technology recently evolved and focused on the treatment of such complex situation. Several devices are available as of today allowing a complete acute limb ischemia endovascular management, aiming to remove intraluminal material while leaving the possibility for treating the underlying pathology when needed. In this review, proper specific device characteristics, indications and advantages are reported and discussed. Despite the broad spectrum of different available devices could appear as potentially confounding, each device has its own features, indications, weak and strength point. Ideally the modern endovascular surgeon should master every single tool, tailoring revascularization strategy and timing for the proper patient and arterial segment to be treated, maximizing the benefits coming from technological improvements.

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.

Editor's Choice - Early Outcomes of a Novel Off the Shelf Preloaded Inner Branch Endograft for the Treatment of Complex Aortic Pathologies in the ItaliaN Branched Registry of E-nside EnDograft (INBREED).

OBJECTIVE: The aim of this study was to investigate the early outcomes of a novel off the shelf pre-loaded inner branched thoraco-abdominal endograft (E-nside) in the treatment of aortic pathologies. METHODS: Data from a physician initiated national multicentre registry on patients treated with the E-nside endograft, were prospectively collected and analysed. Pre-operative clinical and anatomical characteristics, procedural data, and early outcomes (90 days) were recorded in a dedicated electronic data capture system. The primary endpoint was technical success. Secondary endpoints were early mortality (90 days), procedural metrics, target vessel patency, endoleak rate, and major adverse events (MAEs) at 90 days. RESULTS: In total, 116 patients from 31 Italian centres were included. Mean ± standard deviation (SD) patient age was 73 ± 8 years and 76 (65.5%) were male. Aortic pathologies included degenerative aneurysm in 98 (84.5%), post-dissection aneurysm in five (4.3%), pseudoaneurysm in six (5.2%), penetrating aortic ulcer or intramural haematoma in four (3.4%), and subacute dissection in three (2.6%). Mean ± SD aneurysm diameter was 66 ± 17 mm; aneurysm extent was Crawford I - III in 55 (50.4%), IV in 21 (19.2%), pararenal in 29 (26.7%), and juxtarenal in four (3.7%). The procedure setting was urgent in 25 (21.5%) patients. Median procedural time was 240 minutes (interquartile range [IQR] 195, 303), with a median contrast volume of 175 mL (IQR 120, 235). The endograft's technical success rate was 98.2% and the 90 day mortality rate was 5.2% (n = 6; 2.1% for elective repair and 16% for urgent repair). The 90-days cumulative MAE rate was 24.1% (n = 28). At 90 days, there were 10 (2.3%) target vessel related events (nine occlusions and one type IC endoleak) and one type 1A endoleak requiring re-intervention. CONCLUSION: In this real life, non-sponsored registry, the E-nside endograft was used for the treatment of a broad spectrum of aortic pathologies, including urgent cases and different anatomies. The results showed excellent technical implantation safety and efficacy, as well as early outcomes. Longer term follow up is needed to better define the clinical role of this novel endograft.

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.

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.

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.

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.

The new educational project Televascular Games during the Coronavirus Disease 2019 pandemic.

Objective: To report methodology and first-year results of a new educational project called Televascular Games," which took place during coronavirus disease 2019 pandemic. Methods: Complex aneurysmal aortic disease was discussed during a 2-hour competition webinar, according to three modalities. (1) Planning case competition (PCC): Two to four preoperative computed tomography angiography (CTA) scans of an already performed selected case were submitted for the competition. CTA scans were uploaded anonymously, without any reference to the center or the surgeon who performed the case. The competitor had to prepare a presentation of how he or she would have diagnosed, sized, planned, treated, and followed up the case, of the medical therapy and of the bail-out maneuvers. (2) Challenging case competition (CCC): The competitor elaborates a presentation of an already treated case concerning an aortic topic and discusses sizing, planning, treatment, possible bail-out maneuvers and obtained results. For the CCC and PCC, the competitors with the best score were preselected to present and discuss their plan during the webinars. (3) Quiz competition: Two to six CTA scans of already performed selected aortic cases were submitted for the competition. A quiz with multiple choice questions was answered by the competitors. The top four competitors were selected for the webinars and then they discussed the cases during the webinar. Finally, at the end of the case discussion, the effective case resolution and follow-up were shown. A final winner was voted via televoting, based on six preestablished criteria. The project was endorsed by different national and international societies. Results: Between October 2020 and December 2021, there were 12 Italian and 1 international webinars with 1695 participants overall (mean, 130; range, 86-177). Competitors were 54 years of age (mean, 27 years; range, 22-38 years). Two editions were CCCs, two quiz competitions, and nine PCCs. The reliability of the interobserver sizing of competitors was κ = 0.43 and κ = 0.62 for the proximal and distal sealing measurements respectively and very good (κ = 0.88-0.95) in the evaluation of orientation of the vessels, presence of angulations, calcifications, and thrombus. The sizing discrepancy resulted in a significant variability of the planning (κ = 0.45). The project ranked 9.6 on a 10-point rating scale by all the participants and competitors. Conclusions: The formula of gaming and collegial discussion of aortic cases herein reported has proved valid and attractive during coronavirus disease 2019 pandemic period. The variability of the results on sizing and planning suggested to confer with a second opinion, especially for less experienced surgeons.

Fenestrated and Branched Endografts for Post-Dissection Thoraco-Abdominal Aneurysms: Results of a National Multicentre Study and Literature Review.

OBJECTIVE: Fenestrated and branched endografting (F/B-EVAR) has been proposed as an endovascular solution for chronic post-dissection thoraco-abdominal aneurysms (PD-TAAAs). The aim of this study was to analyse the experience of four high volume centres nationwide and the current available literature. METHODS: Data on patients undergoing F/B-EVAR in four Italian academic centres between 2008 and 2019 were collected, and those from patients with PD-TAAAs were analysed retrospectively. Peri-operative morbidity and mortality were assessed as early outcomes. Survival, freedom from re-intervention (FFR), target visceral vessel (TVV) patency, and aortic remodelling were assessed as follow up outcomes. A MEDLINE search was performed for studies published from 2008 to 2020 reporting on F/B-EVAR in PD-TAAAs. RESULTS: Among 351 patients who underwent F/B-EVAR for TAAAs, 37 (11%) had PD-TAAAs (Crawford's extent I-III: 35% - 95%). Overall, 135 TVVs (from true lumen 120; false lumen seven; both true and false lumen eight) were accommodated by fenestrations (96% - 71%) and branches (39% - 29%). Technical success (TS) was achieved in 34 (92%) cases with three failures due to endoleaks (Ia: 1; Ic: 1; III: 1). There were no 30 day deaths. No cases of permanent spinal cord ischaemia (SCI) were recorded and six (16%) patients suffered from transient deficits. Renal function worsening (eGFR < 30% than baseline) and pulmonary complications were reported in two (5%) and four (11%) cases, respectively. From the Kaplan-Meier analysis, three year survival, FFR, and TVV patency were 81%, 66%, and 97%, respectively. Radiological imaging was available for 30 (81%) patients at 12 months with complete false lumen thrombosis in 26 (87%). Two hundred and fifty-six patients were reported in seven published papers with TS, 30 day mortality, and SCI ranging from 99% to 100%, 0 to 6%, and 0 to 16%, respectively. The mean follow up ranged from 12 to 26 months, with estimated two year survival between 81% and 90% and a re-intervention rate between 19% and 53%. CONCLUSION: F/B-EVAR is effective to treat PD-TAAAs. A high re-intervention rate is necessary to complete the aneurysm exclusion and promote aortic remodelling successfully.

Bridging stent graft fracture after branched endovascular aortic repair in a dual-center retrospective cohort study.

OBJECTIVE: Target vessel instability is a relevant complication after thoracoabdominal aortic aneurysms branched endovascular aortic repair (BEVAR). Long-term bridging stent graft (BSG) durability has already been established, but the incidence of long-term complications as component fractures was not deeply investigated. This paper aims to assess BSG fracture incidence and risk factors after BEVAR. METHODS: This was a dual-center observational retrospective cohort study. Data of each patient treated with BEVAR between April 2008 and December 2019 were prospectively collected. The primary outcome was the incidence of BSG fracture during follow-up. A logistic regression analysis was performed, including preoperative and postoperative measurements as well as intraoperative details to identify potential risk factors. RESULTS: Two hundred ninety-five target visceral vessels in 91 patients were considered suitable for cannulation. Technical success was 96.9% (286/295 target visceral vessels). The median follow-up was 32.5 months (interquartile range, 14.3-50.1 months). Five BSG fractures (1.75%; 5/286) were detected. Four BSG fractures involved the superior mesenteric artery, and one the celiac trunk. Four different types of fractured stents were detected during follow-up: two Advanta, one BeGraft, one Fluency, and one Viabahn. The median time to BSG fracture was 28.2 months (interquartile range, 11.7-50.8 months). The use of multiple stents (P = .030) and different stent types on the same vessel (P = .004) were associated with BSG fracture at univariable analysis. Using bare-metal stents for distal relining (P = .045) was the only significant factor predisposing to BSG fracture at multiple logistic regression. CONCLUSIONS: BSG fracture is a rare but severe complication after BEVAR. It is not related to the stent type used as bridging stent, and it is hardly predictable based on preoperative anatomy. Using multiple and different stents on the same vessel and relining the bridging stents with bare-metal stents may increase BSG fracture risk. A strict computed tomography angiography follow-up remains the best strategy to detect target vessel instability.

Results of adjunctive stenting with high-radial force stents to prevent or treat limb occlusion after EVAR.

BACKGROUND: The aim of this study was to report the results of a multicenter experience on the use of adjunctive stents deployed inside abdominal aortic endografts with the purpose to prevent or treat limb occlusion after endovascular aneurysm repair (EVAR). METHODS: Between 2010 and 2018, there were 35 patients with aorto-iliac aneurysm presenting one or more risk factors for endograft limb occlusion (narrow aortic bifurcation and/or stenotic, highly angulated or occluded iliac arteries), who were treated with standard bifurcated stent graft reinforced by the means of a single model of balloon-expandable platinum/iridium bare stent (CP Stent; NuMED, Inc., Hopkinton, NY, USA). Technical success, mortality, limb patency and reintervention rate during follow-up were the main endpoints assessed. RESULTS: Technical success was 100%. No patients died perioperatively and no major complication was registered. During a mean follow-up of 48 months (range 1-87), neither aortic-related death nor secondary intervention was registered. At a mean follow-up imaging of 39.4 months (range 1-81) no endograft limb lost its patency. CONCLUSIONS: The use of high-radial force balloon-expandable stents deployed inside bifurcated endografts to prevent or treat limb occlusion is a safe and effective adjunctive procedure, with outstanding long-term outcomes in terms of patency and reinterventions.

Nineteen-year outcomes with the Anaconda stent graft system from two tertiary centers.

OBJECTIVE: The Anaconda stent graft device presents peculiar and unique features in its design and deployment sequence, available on the market for many years with minor modifications, among different generations. The aim of this study was to assess the long-term, real-life, outcomes obtained in two high-volume centers with this endograft for infrarenal aortic aneurysms treatment over a period of 19 years. METHODS: All patients treated with the investigated device between 2000 and 2019, with at least 1 year of follow-up, were entered into a prospective database and data were reviewed retrospectively. The long-term results were assessed according to the Kaplan-Meier method. Primary outcomes were overall survival, freedom from AAA rupture, and freedom from AAA-related death. Secondary outcomes were freedom from late reintervention, freedom from late conversion to open repair, freedom from late limb occlusion, and freedom from late EVAR failure. RESULTS: A total of 260 consecutive patients were treated during the study period. Technical success was achieved in 98.5% (256/260) of the cases. Two perioperative deaths (0.8%) and four major complications (1.5%) were recorded. At a mean follow-up of 54 ± 38 months (summary follow-up index = 0.86), the late survival estimate was 94.8% at 1 year, 75.2% at 5 years, 50.5% at 10 years, and 43.3% at 13 years, with no case of late AAA rupture or late AAA-related death. Late freedom from conversion was 99.2% at 1 year, 96.9% at 5 years, 94.0% at 10 years, and 94.0% at 13 years. Freedom from late limb thrombosis was 96.8% at 1 year and 91.0% at 5, 10, and 13 years. Estimates of freedom from late reintervention was 95.6% at 1 year, 87.0% at 5 years, 77.4% at 10 years, and 77.4% at 13 years. Estimates of limb thrombosis at 11 years were significantly different in patients receiving or not intraoperative iliac kissing balloon maneuver with noncompliant angioplasty catheters (98.0% vs 88.4%; P = .029). CONCLUSIONS: The Anaconda stent graft demonstrated effective and durable outcomes for AAA treatment over a 19-year period, with no case of late AAA rupture or AAA related death in the studied population. Late limb occlusion was the leading cause of reintervention; however, a positive prevention strategy was found in intraoperative kissing balloon, which was associated with significant reduced rate of iliac thrombosis over time.