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.

Comparison of bare and nonbare stent grafts during thoracic endovascular aneurysm repair of the aortic arch.

OBJECTIVE: We compared the outcomes of patients treated with nonbare stents (NBS) and proximal bare stents (PBS) endografts with a proximal landing zone in the aortic arch during thoracic endovascular aortic repair (TEVAR). METHODS: We conducted a retrospective cohort, observational, multicenter study that included 361 consecutive TEVAR procedures undertaken between November 2005 and December 2021. TEVAR patients with both BS and NBS Relay stent graft configurations with proximal landing in zones 1, 2, or 3 were enrolled. Preoperative anamnestic and morphological data, clinical outcomes, and aortic modifications 30 days after surgery and at the latest follow-up available were collected. The primary outcome was freedom from proximal endoleak (type IA) comparing the two configurations. Total and detailed endoleak rates, clinical and technical success, intraoperative additional maneuvers, major adverse events, and reinterventions were secondary outcomes. RESULTS: The median follow-up was 4.9 (interquartile range, 2.0-8.1) years. No statistically significant difference between NBS and PBS patients concerning 30-day major adverse events, retrograde aortic dissection, disabling stroke, or late type IA endoleak (10.8% vs 7.8%; P = .597). Aneurysmal disease (P = .026), PLZ diameter of >34 mm (P = .026), aortic tortuosity index of >1.4 (P = .008), type III aortic arch (P = .068), and PLZ thrombus (P = .014) identified as risk factors by univariate Cox regression analysis. PLZ thrombus was the only type IA endoleak risk factor at multivariate Cox regression (P = .016). CONCLUSIONS: We found no statistically significant difference in freedom from type IA endoleak, retrograde dissection, or disabling stroke observed between the NBS and the BS configuration of the Relay endograft. Proximal landing zone thrombotic apposition was a prominent risk factor for type IA endoleak after TEVAR.

Type III Endoleak Incidence and Outcomes in Endovascular Aortic Repair: Comparison of Anatomical and Proximal Fixation Devices.

PURPOSE: To evaluate the influence of endograft fixation type on the incidence, treatment, and outcomes of type III endoleaks (TIIIELs). MATERIALS AND METHODS: Abdominal aortic aneurysms (AAAs) treated with bifurcated endografts between 1994 and 2020 were prospectively collected and reviewed. The endograft included were classified as "Anatomical Fixation" (AF) (Powerlink [Endologix] and AFX [Endologix]) or "Proximal Fixation" (PF). The primary outcome was the incidence of TIIIEL over time, stratified by fixation type. Secondary outcomes included between-group comparisons of baseline characteristics, intraoperative details during TIIIEL correction, and survival analysis after TIIIEL diagnosis. RESULTS: A total of 2065 endovascular aneurysm repairs were performed: 872 (42.2%) with AF and 1193 (57.8%) with PF devices. The estimated incidence of TIIIEL at 1, 5, and 10 years was 0.4%, 4.2%, and 7.3%, and 0.5%, 3.2%, and 4.6% for AF and PF, respectively (p=0.157), and fixation type was not associated with TIIIEL development in the competing risk regression model (p=0.101). The cumulative overall survival rate in patients diagnosed with TIIIEL did not differ significantly between the groups (p=0.077). The rate of recurrent TIIIELs was significantly lower in the AF group (7.1% vs 22.7%; p=0.044); however, no significant difference was found in secondary reintervention between the two groups (11.9% vs 27.3%, p=0.074). Patients with angulated and calcified aortic neck (SHR 3.4, 95% CI 1.2-9.6, p=0.022) and larger aneurysms (SHR 1.2; 95% CI 1.1-1.3; p<0.001) had a higher risk of TIIIEL. Likewise, the use of three or more endograft components increased the risk of TIIIEL by 3.1 times (SHR 3.1; 95% CI 1.7-5.4; p<0.001). CONCLUSIONS: The occurrence of TIIIELs was not affected by the type of endograft fixation. For larger abdominal aortic aneurysms (AAAs) and aneurysms with angulated and calcified aortic necks, there is a higher likelihood of developing TIIIELs during follow-up, regardless of the endograft type used. CLINICAL IMPACT: The type of fixation does not influence the incidence of TIII ELs. EVAR in larger AAAs and aneurysms with angulated and calcified aortic necks have a higher risk of developing TIII EL. Moreover, the risk of TIII EL is considerably increased by the use of three or more modular components.

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.

Comprehensive Learning Curve Analysis of a Long-Term Experience With Thoracic Endovascular Aneurysm Repair.

PURPOSE: To analyze the learning curve for thoracic endovascular aortic repair (TEVAR) in a single center over a period of 25 years. MATERIALS AND METHODS: In total, 390 consecutive standard TEVAR procedures undertaken between 1996 and 2021 were included in a retrospective, observational, single-center study. Cumulative sum charts were elaborated for the entire center experience (primary outcome) as well as for the first and second implanting physicians. Data on procedural variables (contrast volume, operative and fluoroscopy time), 30-day major adverse events (MAEs) and clinical success, and endoleak and reintervention rates were secondary outcomes and subdivided into 4 quartiles of experience (Q1-Q4) or presented as first 2 versus latest 2 quartiles (Q1-Q2 vs Q3-Q4). RESULTS: The mean follow-up was 4.3±4.0 years. The center's learning curve was achieved after 75 procedures, and it was similar for the first implanting physician. The surgeon coming thereafter had a significantly shorter curve (10 TEVARs). Comparing Q1-Q2 with Q3-Q4, 30-day MAEs (16.1 vs 11.3%, p=0.164), 30-day mortality (11.4% vs 3.6%, p=0.003), and intraoperative additional maneuvers (21.5% vs 13.3%, p=0.033) were reduced along with an improvement in clinical success (85.9% vs 90.3%, p=0.190). From Q1 to Q4, operative time (139.8±65.5 to 76.7±43.7 min, p=0.001), fluoroscopy time (15.1±8.8 to 7.1±5.1 min, p<0.001), and contrast volume (244.0±112.1 to 104.3±46.1 mL, p<0.001) showed a considerable reduction. Late endoleak and aortic-related mortality declined significantly from Q1-Q2 to Q3-Q4 (24.1% to 15.5%, p=0.033 and 18.6% vs 8.2%, p=0.006, respectively). Operative time (p=0.021), contrast volume (p=0.016), and fluoroscopy time (p=0.004) were independent risk factors for endoleak, causing a 1.3-fold risk increase for both each 60 minutes of additional operative time (p=0.021) and every 100 mL of additional contrast medium (p=0.016). Each 10-minute increase in fluoroscopy time determined a 1.4-fold risk increment (p=0.004). CONCLUSION: The learning curve shortened significantly over time with non-negligible clinical outcome improvements, suggesting that specific endovascular training is mandatory to become an effective TEVAR performer. CLINICAL IMPACT: For the first time in literature, the standard TEVAR's learning curve has been evaluated at a single vascular surgery center over a period of 25 years. The learning curve for the center and the first physician historically undertaking TEVAR was achieved at the 75th treated patient. The learning curve of the surgeons coming thereafter was significantly shorter (10 cases). This quarter-century demonstrated that intraoperative learning-related variables were associated with long-term clinical outcomes and all have improved over time. Centers approaching TEVAR for the first time and training program providers could use these data to aim to offer better clinical outcomes.

Anatomical Feasibility of an Off-the-shelf Single-Renal Scalloped Stent-Graft for Hostile Neck Abdominal Aortic Aneurysm: A Preclinical Study.

OBJECTIVES: To evaluate the feasibility of a standardized single-renal scallop stent-graft. DESIGN: Preclinical, single-center, real-world, all-comers, retrospective cohort study. METHODS: A total of 1347 abdominal aortic aneurysm (AAA) repairs (endovascular and open) performed between 2010 and 2020 were screened for elective treatment and retrievable preoperative high-quality computed tomography angiography (CTA) performed <6 months of the surgical procedure. Six hundred of the included CTAs involved prespecified measurements and a morphological assessment protocol (NCT05150873). The proximal sealing zones suitable for standard stent-graft implantations were further analyzed (N=547). The primary outcome assessed the feasibility of 2 single-renal scallop designs (10×10 mm and 15×10 mm, height × width). The feasibility was the inter-renal length ≥10 mm and ≥15 mm for prototypes #10 and #15, respectively. The secondary outcome quantified hypothetical length and surface improvements comparing those suitable for investigational devices implantation (study group) versus those not (control group). RESULTS: Of the total, 24.7% (n=135) was feasible with prototype #10. The study versus control group sealing zones were shorter (p=0.008), with a smaller surface (p=0.009) and a higher alpha angle (p=0.039). The length and surface area increased by about 25% and 23%, respectively, (both p<0.001) within the study group and became significantly better versus the control group (standard stent-graft; both p<0.001). Of the total, 7.1% (n=39) was suitable for prototype #15. The study versus control group sealing zones were shorter (p=0.148), with a smaller surface (p=0.077) and a higher alpha angle (p=0.027). The length and surface area increased by about 34% and 31%, respectively, (both p<0.001) within the study group and became significantly higher versus the control group (standard stent-graft; both p<0.001). CONCLUSIONS: The use of single-renal scalloped stent-graft might be feasible in a considerable number of AAA patients. The breakthrough stands in treating hostile AAAs presenting in mismatched renal arteries, keeping the complexity of the repair as similar as possible to standard endovascular repair with a remarkable improvement in sealing. CLINICAL IMPACT: The anatomic feasibility of a single renal stent graft for the treatment of "hostile" abdominal aortic aneurysm (AAA) with mismatched renal arteries was evaluated. The experimental device could be feasible in a considerable number of patients with AAA, approaching 25%, and demonstrate significant improvements in sealing. As far as we know, this is the first paper to report the prevalence of mismatched renal arteries in a large cohort of AAA patients in the real world, while proposing a dedicated device. The breakthrough is to keep the complexity of the repair as close as possible to standard endovascular repair.

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.

Two Decades of Abdominal Aortic Endovascular Repair With the Anatomical FiXation at the Aortic Bifurcation in a Large Single-Center Experience.

OBJECTIVE: The introduction of new endograft models improved long-term results of abdominal aortic aneurysm (AAA) endovascular repair (EVAR), but most of them maintained an old and unchanged design: a short body and long legs shifting up the flow divider. This study assessed the long-term results of EVAR with unimodular endoprosthesis fixed at the aorto-iliac bifurcation (Anatomical FiXation), in a large, unselected cohort. MATERIALS AND METHODS: In a single-center, retrospective cohort study, 623 patients selectively treated between 1999 and 2016, were analyzed. Follow-up protocol included at least a computed tomography angiography within 3 months and a duplex ultrasound and clinical exam yearly. All enrolled patients were analyzed by 2020. The primary outcomes were technical success, clinical success, and survival. Secondary outcomes included survival-free from late-open-conversion (LOC), reintervention, and endoleaks. RESULTS: Median age was 74±11 years and the follow-up 93±54 months. The technical success was achieved in 99.4% and the 30-day clinical success was 98.4%. A 5-year clinical success of 97.7% was registered and at 10 years success was 96.7%. The overall survival at 1, 5, 10, and 15 years was 92.4%, 79.5%, 64.9%, and 45.5%, respectively. Six (0.98%) AAA-related death were registered, 3 caused by infection of the endograft and 3 for secondary rupture. LOCs were 9 (1.47%) and reintervention-free survival at 1, 5, 10, and 15 years were 88.4%, 78.0%, 76.2%, and 74.6%, respectively. Freedom from endoleaks was 88.8% at 1 year and 72.7% at 15 years. A total of 63 high-flow endoleaks were registered (43 type I, 7 type IIIa, 12 type IIIb, and 1 type Ib+IIIb). No migrations were recorded, and the graft limb thrombosis rate was 1.14%. From a multivariate analysis resulted that long-term clinical success appeared to be reduced in patients affected by diabetes [odds ratio (OR) 0.24; p=0.04] and in presence of calcified and thrombotic iliac accesses (OR 0.16; p=0.006). CONCLUSION: EVAR with the Anatomical FiXation was confirmed to be safe, feasible, and effective to prevent AAA rupture in the long term as well. However, the overall survival remains afflicted by cardiovascular accident. The original concept of unibody bifurcated design allowed a very low rate of graft thrombosis and zeroed the risk of migration and related reintervention.

An International, Multicenter Retrospective Observational Study to Assess Technical Success and Clinical Outcomes of Patients Treated with an Endovascular Aneurysm Sealing Device for Type III Endoleak.

INTRODUCTION: Type III endoleaks post-endovascular aortic aneurysm repair (EVAR) warrant treatment because they increase pressure within the aneurysm sac leading to increased rupture risk. The treatment may be difficult with regular endovascular devices. Endovascular aneurysm sealing (EVAS) might provide a treatment option for type III endoleaks, especially if located near the flow divider. This study aims to analyze clinical outcomes of EVAS for type III endoleaks after EVAR. METHODS: This is an international, retrospective, observational cohort study including data from 8 European institutions. RESULTS: A total of 20 patients were identified of which 80% had a type IIIb endoleak and the remainder (20%) a type IIIa endoleak. The median time between EVAR and EVAS was 49.5 months (28.5-89). Mean AAA diameter prior to EVAS revision was 76.6±19.9 mm. Technical success was achieved in 95%, 1 patient had technical failure due to a postoperative myocardial infarction resulting in death. Mean follow-up was 22.8±15.2 months. During follow-up 1 patient had a type Ia endoleak, and 1 patient had a new type IIIa endoleak at an untreated location. There were 5 patients with aneurysm growth. Five patients underwent AAA-related reinterventions indications being: growth with type II endoleak (n=3), type Ia endoleak (n=1), and iliac aneurysm (n=1). At 1-year follow-up, the freedom from clinical failure was 77.5%, freedom from all-cause mortality 94.7%, freedom from aneurysm-related mortality 95%, and freedom from aneurysm-related reinterventions 93.8%. CONCLUSION: The EVAS relining can be safely performed to treat type III endoleaks with an acceptable technical success rate, a low 30-day mortality rate and no secondary ruptures at short-term follow-up. The relatively low clinical success rates, related to reinterventions and AAA enlargement, highlight the need for prolonged follow-up.

Intravascular Ultrasound in Branched and Fenestrated Endovascular Aneurysm Repair: Initial Experience in a Single-Center Cohort Study.

PURPOSE: To evaluate intravascular ultrasound (IVUS) safety and efficacy to detect visceral stenting issues during complex endovascular aneurysm repair through branched and fenestrated repair (B-FEVAR). MATERIALS AND METHODS: A single-center retrospective analysis of 33 bridging stents assessed intraoperatively using IVUS between January and September 2020 was performed. Ten aortic aneurysm patients [7 thoracoabdominal / 1 pararenal / 2 juxtarenal; 3 females; mean age 73 years [range 70-77 years]) were included. Eight BEVAR (5 standard; 2 custom-made) and 2 FEVAR (custom-made) were performed. The study assessed the safety and efficacy of IVUS utilization to detect immediate branch instability after visceral stenting in the case of B-FEVAR. The primary safety endpoint was defined as the absence of IVUS-related adverse events. The primary efficacy endpoint was defined as the composite of technical success of the IVUS-assessment in each target visceral vessels (TVVs), the rate of IVUS-findings divided as prompting additional maneuvers or not, and the incidence of postoperative computed tomography angiography findings compared with intraoperative assessment. RESULTS: There were no IVUS-related adverse events. The technical success of the IVUS-assessment was achieved in all TVVs. No technical issues compromised the evaluation of the intended vessel. Among the 7 findings identified by IVUS, 3 were suspected at the angiography. In all, 57% (4/7) had normal final angiography. IVUS was able to detect a 12% (4/33) intraoperative branch instability not identified/suspected at the completion angiography. The IVUS assessment led to an immediate revision in 5 (15%) vessels. A total of 57% (4/7) of the issues were detected in patients undergoing primary BEVAR. The remaining 43% (3/7) was detected in patients undergoing secondary intervention for branch instability. CONCLUSION: IVUS was safe as an adjunctive imaging technique to assess completion after B-FEVAR. It demonstrated efficacy in the detection of intraoperative issues missed by angiography. Further investigations are required to validate these promising results.

Outcome of Endovascular Repair of Popliteal Artery Aneurysms using the Supera Stent.

PURPOSE: To evaluate the efficacy of endovascular repair of popliteal artery aneurysms (PAAs) with a wire-interwoven nitinol stent. MATERIALS AND METHODS: This is a prospective, descriptive, and analytical study. From January 2016 to December 2018, 28 consecutive patients (29 lower limbs) were treated for a PAA with the deployment of the Supera stent (Abbott Vascular, Illinois). Twenty-three (79.3%) PAAs were asymptomatic; 6 (20.7%) presented with symptoms. The mean diameter and length of the aneurysm were 26.8 mm (20-40 mm) and 47.1 mm (23-145 mm) respectively. The primary endpoint was the prevention of embolic symptoms. The secondary endpoints were aneurysm exclusion, aneurysm diameter decrease, freedom from reintervention, and preservation of preoperative runoff vessels. RESULTS: Technical success was 100%, with a median of 2.4 run-off vessels at completion angiography, without any loss of run-off vessels. A double Supera stent was deployed in 10 cases. At completion angiography, a median of 2.4 runoff vessels were present, without any loss of runoff vessels. The mean follow-up time was 24.3 (12-35) months. Primary endpoints were reached in 100% of the cases and vessels run off was preserved in all cases. In 2 PAAs, complete sac thrombosis was witnessed at 6-month follow-up, while at 12-month follow-up, it was seen in 10 of 29 (34.4%) limbs. In all the other cases the diameter of the aneurysm remained stable, with a freedom from sac enlargement of 100%. No fractures or stent thromboses were detected. CONCLUSIONS: For endovascular repair of PAAs, the use of a thick interwoven-wire stent, that could work like a multilayer flow modulator showed encouraging mid-term results with no cases of stent fracture, occlusion or aneurysm increase.

Late open conversions after endovascular abdominal aneurysm repair in an urgent setting.

OBJECTIVES: We report a multicenter experience of urgent late open conversion (LOC), with the goal of identifying the mode of presentation, technical aspects, and outcomes of this cohort of patients. METHODS: A retrospective analysis of endovascular aneurysm repair (EVAR) requiring LOC (>30 days after implantation) from 1996 to 2016 in six vascular centers was performed. Patients with aneurysm rupture or other conditions requiring urgent surgery (<24 hours) were included. Patient demographics, time interval between EVAR and LOC, endograft characteristics, previous attempts at endovascular correction, indications, operative technique, 30-day mortality and morbidity, and long-term survival were analyzed. RESULTS: There were 42 patients (88.1% men; mean age, 75.8 ± 9.0 years) included. Among the 42 explanted grafts, 33 were bifurcated, 1 tube, 6 aortouni-iliac, and 2 side-branch devices. Suprarenal fixation was present in 78.6%. Twelve patients (28.6%) underwent endovascular reintervention before LOC. Indications for urgent LOC were aneurysm rupture in 24 of the 42 cases (57.1%), endograft infection in 11 (26.2%), endoleak associated with aneurysm growth and pain in 6 (14.3%), and recurrent endograft thrombosis in 2 (4.8%). The proximal aortic cross-clamping site was infrarenal in 38.1% of cases, suprarenal in 19.1%, and supraceliac in 42.9%. Complete removal of the endograft was performed in 32 patients (76.2%) and partial removal in 10 (proximal preservation in 7 of 10). Reconstructions were performed with Dacron grafts in 33 of the 42 cases, cryopreserved arterial allografts in 5, and endograft removal associated with prosthetic axillobifemoral bypass in 4. The 30-day mortality was 23.8%; hemorrhagic shock was an independent risk factor of early mortality (odds ratio, 10.5; 95% confidence interval, 1.5-73.7; P = .018). During a mean follow-up of 23.9 ± 36.0 months, two late aneurysm-related deaths occurred. The estimated 1- and 5-year survival rates were 62.1% and 46.1%, respectively. CONCLUSIONS: Urgent LOC after EVAR are associated with high postoperative mortality rates and poor long-term survival. Further studies are necessary to define the timing and the best treatment option for failing EVAR.

Early Experience with the Covera Stent Graft as a Bridging Stent in Branched Thoraco-Abdominal Endovascular Aneurysm Repairs.

PURPOSE: To evaluate the Covera Plus (Bard, Tempe, Arizona) covered stent as a bridging stent in branched thoraco-abdominal endovascular aneurysm repair (BEVAR). MATERIALS AND METHODS: Retrospective analysis of 112 self-expandable stents was performed at 2 university centers between August 2017 and March 2019. Thirty-one consecutive BEVAR procedures were studied (21 males; mean age, 75 years; 29 American Society of Anesthesiologists grade III/IV) with 119 patent target vessels (7 did not receive the studied device). Primary endpoints were technical success, branch instability, and primary/secondary clinical success. Secondary endpoints included primary/secondary patency and any adverse events. RESULTS: Technical success was 100%. Median follow-up was 12 months (interquartile range, 6-14 months). Branch instability was registered twice (2/112), due to immediate renal occlusion and type Ic endoleak; no additional events occurred during the follow-up. Primary clinical success was 84%. There were 2 immediate deaths, 1 upper limb ischemia, 1 hemorrhage from splenic artery, and 1 type Ic endoleak; these last 3 events were successfully treated, with a secondary clinical success of 100% that was maintained during the follow-up. One late death occurred. Primary patency was 99% (111/112) and 100% (105/105) within 30 days and at the end of the study period,respectively. Adverse events included 4 acute kidney injuries and 2 spinal cord ischemia. No type I/III endoleaks, occlusion, fracture, or dislodging were diagnosed after 30 days. CONCLUSIONS: The stent graft seems safe and effective for bridging in BEVAR with low branch instability and high patency rate. Longer follow-up is required to confirm these promising results.

New Conception of Relining in the Endovascular Aneurysm Sealing Era: A Monocentric Case Series Study.

Over 20 years from the first endovascular aortic repair, endoleaks still represent a common problem, even with newer endograft generation. Numerous procedures can be adopted to manage these complications; relining of the endoprosthesis is a rational technique to treat type III and IV endoleaks. The absence of dedicated materials for these procedures forces the vascular surgeon to perform complex hybrid or endovascular interventions. In this case report, we aimed to evaluate our relining experience using the Nellix device in 5 consecutive cases.

Anatomical feasibility of a 'semi-custom' unibody single-branch endograft in previous zone 2 thoracic endovascular aortic repair.

OBJECTIVES: The aim of this study was to evaluate the suitability of a subclavian unibody single-branch endograft among patients treated with thoracic endovascular aortic repair (TEVAR) in landing zone 2 (LZ2). METHODS: This is a pre-clinical, single-centre, real-world, all-comers, retrospective cohort study. Patients treated with TEVAR in LZ2 with an available preoperative computed tomography angiography were included. The primary outcome was the anatomical feasibility of the Castor endograft in patients receiving endovascular treatment in LZ2 between 1999 and 2022. Secondary outcomes were: a comparison of feasible and unfeasible patients; frequencies and description of exclusion causes; non-feasibility risk factor analysis; and analysis of the stent graft configurations necessary to treat 75% of the patients. A logistic regression model was used to find associations between baseline morphological data and non-feasibility. RESULTS: A total of 473 procedures were performed and 72 patients fulfilling inclusion criteria were included. The mean distance between the left carotid artery and left subclavian artery (or between innominate artery and bovine trunk) was 12.4 ± 5.2 mm and its average diameter was 33.0 ± 10.6 mm. The pre-vertebral left subclavian artery's diameter and length were 11.3 ± 2.5 and 38.7 ± 10.8 mm. Forty-nine (68.1%) patients were suitable for Castor implantation. Twenty-one configurations were required to treat 75% of feasible patients and might be lowered to 12 configurations applying less strict criteria. CONCLUSIONS: The Castor endograft was anatomically feasible in several patients requiring TEVAR in LZ2. Three-quarters of feasible patients could be treated with a reasonable number of configurations, paving the path for future off-the-shelf applications.

Twenty-Five Year Multicentre Experience of Explantation of Infected Abdominal Aortic Endografts.

We report a multicenter experience of open conversions (OC) for aortic endograft infections (AEI). We retrospectively analyzed all patients who underwent OC for AEI after endovascular aneurysm repair (EVAR), from 1997 to 2021 in 12 Italian centers. The endpoints were as follows: mortality (30-days, in-hospital), major postoperative complications. Follow-up data included: survival, aortic-related complications, infection persistence or reoccurrence. Fifty-eight patients (mean age: 73.8 ± 6.6 years) were included. Median time from EVAR to OC was 14 months (interquartile range 7-45). Thirty-five patients (60.3%) were symptomatic at presentation. Aortic reconstruction was anatomic in 32 patients (55.2%), extra-anatomic in 26 (44.8%). Thirty-day mortality was 31% (18/58). Six additional patients died after 30 days during the same hospitalization (in-hospital mortality: 41.4%). Most common post-operative complications included respiratory failure (38.6%) and renal insufficiency (35.1%). During 28.1 ± 4 months follow-up, 4 aneurysm-related deaths were recorded. Infection re-occurred in 29.4% of the patients. Estimated survival was 50% at 1 year, and 30% at 5 years, and was significantly lower for patients who underwent extra-anatomic reconstructions (37 vs 61% at 1 year, 16 vs 45% at 5 years; log-rank P = .021). OC for AEI is associated with high early mortality. The poor mid-term survival is influenced by aortic complications and infection re-occurrence.

Health-related quality of life outcomes and hospitalization length of stay after micro-fragmented autologous adipose tissue injection in minor amputations for diabetic foot ulceration (MiFrAADiF Trial): results from a randomized controlled single-center clinical trial.

BACKGROUND: The diabetic foot ulcer (DFU) is a high prevalence complication that significantly impairs the health-related quality of life (HRQoL) and is characterized by prolonged hospital length of stay (LOS). The impact of the micro-fragmented autologous adipose tissue injection at the minor amputation wound in the case of DFU (MiFrAADiF) on HRQoL and LOS compared to the standard care has not been determined yet. METHODS: This was a two-arm, 6-month, individually-randomized controlled single-center clinical trial. A 1:1 randomization to local injection of autologous micro-fragmented adipose tissue (treatment group; N.=57) or standard clinical care (control group; N.=57) was performed. The primary objective was the HRQoL. The secondary endpoint was the LOS. HRQoL was assessed with the Medical Outcomes Study 36-item Short-Form Health Survey which provides 2 scores focused on physical (PCS) and mental functioning (MCS). The trial was registered in ClinicalTrials.gov (NCT03276312). RESULTS: The type of treatment (P=0.009) and the time elapsed since surgery (P=0.0000) demonstrated a significant improvement on PCS. The MCS improvements resulted in a non-significant association with treatment (P=0.21). The time elapsed since surgery showed a significant influence on the MCS (P=0.0000). The mean LOS was 16.2 days and 24.4 days for the treatment and the control group respectively (P=0.025). CONCLUSIONS: The MiFrAADiF Trial demonstrated a significant improvement in terms of physical HRQoL and a significant reduction of the hospital length of stay after injection of micro-fragmented autologous adipose tissue in diabetic patients' minor amputations wound.

Unibody bifurcated aortic endograft: device description, review of the literature and future perspectives.

The unibody (Powerlink/AFX/AFX2) Endovascular AAA device (Endologix Inc., CA, USA) presents a unique design with its long main body and two innate limbs. The device is designed to be deployed and sits on the native aortoiliac bifurcation and represents the only one-piece bifurcated endograft designed to use anatomical fixation for endograft stabilization. According to published literature, the unibody device seems to represent a valid choice in the treatment of abdominal aortic aneurysms. This particular device would seem to satisfactorily perform even in the treatment of more compressed aneurysms (also in off-label association with parallel grafts) and in occlusive pathologies. Ongoing studies will provide new real-life data in a large and unselected patient population to better understand the device's advantages and limitations.

Unibody Endograft Using AFX 2 for Less Invasive and Faster Endovascular Aortic Repair: Protocol for a Multicenter Nonrandomized Study.

BACKGROUND: Since the introduction of endovascular aortic repair (EVAR) for treatment of abdominal aortic aneurysms (AAAs), progressive improvements in results have been achieved. However, conventional bifurcated stent grafts have been proven to have a nonnegligible risk of failure and secondary intervention, principally due to the lack of adequate proximal sealing. The unique AFX 2 Endovascular AAA System (Endologix, Irvine, CA) unibody device, which provides different sealing and fixation features compared with conventional devices, seems to overcome these limitations. OBJECTIVE: The aim of this study is to evaluate intraoperative, perioperative, and postoperative results in patients treated with the AFX 2 Endovascular AAA System endografts for elective AAA repair in a large cohort of consecutive patients. METHODS: All eligible EVAR patients will be included in this observational, multicenter, prospective, nonrandomized study. The number of patients to be enrolled is 500. RESULTS: The primary endpoint of the study is to evaluate the technical and clinical success of EVAR with unibody endografts in short- (90-day), mid- (1-year), and long-term (5-year) follow-up periods. The following secondary endpoints will also be addressed: operative time, intraoperative radiation exposure, contrast medium usage, AAA sac shrinkage at 12-month and 5-year follow-up, and any potential role of patients' baseline characteristics and device configuration on primary endpoint. The actual start date of the investigation was November 2019. The final patient is expected to be treated by the end of December 2020, and the estimated study completion date is December 2025. CONCLUSIONS: This study will provide verified real-world data on AAAs treated by AFX 2 endografts and followed for a long-term interval. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/16959.