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.

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.

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.

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.

Incidence, Long Term Clinical Outcomes, and Risk Factor Analysis of Type III Endoleaks Following Endovascular Repair of Abdominal Aortic Aneurysm.

OBJECTIVE: To assess the real world incidence, outcomes, and risk factors of type III endoleaks (TIIIEL) after endovascular aneurysm repair (EVAR). METHODS: This was a single centre, retrospective, observational, cohort study. All patients with abdominal aortic aneurysms (AAAs) receiving EVAR between 1994 and 2020 were collected prospectively and reviewed. The primary outcome was the cumulative incidence and impact on survival of TIIIELs, either defined as disconnections of modular graft components (TIIIaEL) or fabric defects (TIIIbEL). Secondary outcomes included risk factor analysis evaluating baseline morphological and stent graft details, as well as a comparison of TIIIaEL and TIIIbEL. RESULTS: In total, 2 565 EVARs were performed and 95 (3.7%) TIIIELs were diagnosed at a median interval of 49.5 months (interquartile range [IQR] 19.4, 67.6). Estimated TIIIEL incidence at five years was 6.8%, 2.2%, and 3.6% for first and second generation, third and fourth generation, and fifth and sixth generation, respectively. The survival rate in patients without any high flow endoleak was 88.0%, 67.9%, 56.9%, and 52.1%, while in TIIIEL patients it was 98.6%, 77.2%, 49.8%, and 32.3% at one, five, 10, and 15 years, respectively (p = .77). The distribution of TIIIaEL and TIIIbEL was 70.5% and 29.5%, respectively. TIIIbEL received a higher rate of open treatment (28.6% vs. 7.5%; p = .005) and device or procedure related re-interventions (35.7% vs. 13.4%; p = .013). Fourteen (15.4%) recurrent TIIIELs were diagnosed at a median of 16.8 months (IQR 7.6, 32.1). Old generation endografts (hazard ratio [HR] 2.1, 95% confidence interval [CI] 1.3 - 3.4; p = .002) and non-proprietary extensions (HR 3.6, 95% CI 1.9 - 6.8; p < .001), and angulated and calcified aneurysm neck (HR 3.6, 95% CI 1.2 - 10.6; p = .017) were risk factors for TIIIEL. Every 10 mm maximum AAA diameter increase presented a 1.4 fold higher risk of TIIIEL. CONCLUSION: TIIIEL is a severe condition that is often fatal if left untreated. Old endografts, the implantation of non-proprietary extensions, large AAAs, and angulated and calcified necks are risk factors for TIIIEL that require careful follow up due to the high rate of recurrence.

Balloon Inducted Re-Lamination and False Lumen Thrombosis in Chronic Type B Aortic Dissection: Technique and Long-Term Results.

BACKGROUND: To evaluate the safety, feasibility, and effectiveness of the BAlloon Inducted re-Lamination and false lUmen Thrombosis (BAILOUT) as a simple technique to address the retrograde false lumen (FL) perfusion and subsequent aneurysmatic degeneration of the thoracic aorta due to a stent-graft crimped in a small true lumen in chronic Type B dissections. METHODS: An observational, retrospective, single-center study analyzing a nonconsecutive cohort of 8 patients affected by chronic type B aortic dissections already treated with thoracic endovascular repair and with an FL lumen backflow corrected with BAILOUT between 2006 and 2020. After a standard distal extension of the previously implanted graft, the distal end of the graft area was ballooned to completely rupture the dissection lamella to relaminate the aorta hindering the FL backflow. Computed tomography was routinely performed within the first postoperative week before discharge and then at 3 months, at 6 months, and yearly thereafter. The technical and clinical success rates were analyzed. Primary outcomes were safety and feasibility of the technique, secondary ones included FL thrombosis evaluation, and total aortic diameter analysis at the above-defined levels during the follow-up. Safety was defined if clinical success was reached. Feasibility was intended as technical success obtention. RESULTS: The technical and clinical success achieved was 100% with the complete interruption of FL backflow stating the safety and feasibility of the BAILOUT technique. No early procedure reinterventions were recorded and during a median follow-up of 62.5 months [interquartile range 43.2-94.1], only 1 death unrelated to the procedure was recorded. Freedom from aortic-related adverse events at 1 month, 3 months, 1 year, 5, and 7 years was 87.5%, 62.5%, 62.5%, 62.5%, and 62.5%, respectively. During the follow-up, no one increment of the diameter of the thoracic aorta was documented and all the patients at 3 years of computed tomography angiography showed a complete FL thrombosis. CONCLUSIONS: The BAILOUT technique demonstrates to be safe and feasible in this small cohort of patients as a simple and quick way to overcome the issue of FL backflow in chronic type B dissection. Small cohort and retrospective designs were limitations of the study.

Learning Curve and Long-Term Outcomes of Thoracic Endovascular Repair With the Relay Stent-Graft.

PURPOSE: To define the learning curve of a widely employed stent-graft for thoracic endovascular repair (TEVAR) by analyzing procedural variables and their impact on long-term outcomes. MATERIALS AND METHODS: Standard TEVARs for each major aortic thoracic disease were included excluding procedures using thoracoabdominal, arch fenestrated/branched devices and/or chimneys. The primary outcome was the learning curve analysis using the cumulative sum chart method. The secondary outcomes, presented as early (Q1-Q2) versus latest (Q3-Q4) quartiles of experience, were 30-day major adverse events (MAEs); procedural details (additional maneuvers, operative and fluoroscopy time, and contrast volume); 30-day clinical success; endoleak; aorta-related reintervention; and overall and aorta-related survival. RESULTS: Between November 2005 and September 2021, 220 consecutive TEVAR procedures involving the Relay endograft (Terumo Aortic, Sunrise, FL, USA) were performed and included in the present analysis. The mean follow-up was 4.5 ± 3.9 years. The learning curve was reached after 10 patients. Secondary outcomes improved significantly over experience. Thirty-day MAE occurrence was 14.5% versus 11.8% (p=0.550). Additional maneuvers (p=0.009), access-vessel additional maneuvers (p=0.010), operative time (p=0.004), Relay Plus (p=0.001), and implantation of multiple stent-grafts (p=0.034) were independent risk markers for MAEs. Operative time (125.9 ± 66.7 vs 86.7 ± 48.5 minutes, p<0.001), contrast volume (185.4 ± 112.8 vs 140.5 ± 88.2 mL, p=0.003), and fluoroscopy time (12.4 ± 12.7 vs 8.8 ± 7.5 minutes, p=0.017) decreased significantly. Late endoleak occurrence was 19.5% with a nonsignificant reduction (21.8% vs 17.3%, p=0.395). Fluoroscopy time (hazard ratio [HR]=1.0; 95% confidence interval [CI]=1.0-1.1; p=0.008), contrast volume (HR=1.0; 95% CI=1.0-1.1; p=0.018), and type III aortic arch (HR=3.3; 95% CI=1.7-6.4; p<0.001) were independent risk markers for endoleak. Fluoroscopy time (HR=1.0; 95% CI=1.0-1.1; p=0.032) and type III aortic arch (HR=3.6; 95% CI=1.7-7.4; p=0.001) confirmed their significant association in a multivariable analysis. CONCLUSION: In a high-volume center with a consistent previous endovascular experience, the Relay graft presented satisfactory long-term results with a short learning curve supporting its reliability. CLINICAL IMPACT: The manuscript addresses the understanding of how many TEVAR procedures with a currently implanted device have been required to reach the learning curve for an endovascular skilled center. Our TEVAR experience with the Relay stent-graft (Terumo Aortic) demonstrated that ten implantations were required to achieve the device-related learning curve. The fifteen-year analyzed period showed that intraoperative learning-related variables were associated with long-term clinical outcomes and both improved over time. The Relay stent-graft presented satisfactory long-term results along with a short learning curve in a high-volume endovascular center supporting its ongoing implantation.

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.

Endoleak outcomes with different stent-graft generations in a 25-years thoracic endovascular aortic repair experience.

INTRODUCTION: To compare endoleak outcomes after thoracic endovascular aneurysm repair (TEVAR) with different stent-graft generations into long-term follow-up. DESIGN: retrospective, observational, and single-center cohort study. METHODS: TEVAR procedures performed between November 1995 and December 2020 were analyzed. The primary endpoint of this study was the freedom from endoleak (type I/III) in four stent-graft generations during the follow-up period. The first generation (GEN1) included: Vanguard; AneuRx and Talent; Stentor; Excluder; Endologix; EndoFit. The second generation (GEN2) included: TAG and TX. The third (GEN3) included: Relay Plus; Valiant Captivia; Zenith Alpha and custom-made. The fourth (GEN4) included: Relay Pro; Conformable C-TAG; Navion; E-Vita; Najuta; Nexus; standard and custom-made thoraco-abdominal devices. Nonaortic and aorta-related survival was considered as secondary outcome. RESULTS: A total of 509 TEVAR were included with a 44.3 ± 42.5 months mean follow-up. Freedom from endoleak at 5 years was 65.6%, 61.4%, 76.2%, and 69.1% for GEN1, GEN2, GEN3, and GEN4, respectively (p = 0.368). The first two generations demonstrated a higher endoleak rate when compared with the two most recent ones (27.2 vs 18.2%, respectively; p = 0.043). GEN1 was an independent risk factor (p = 0.014) and GEN4 was an independent protective factor (p = 0.001) for endoleak. GEN1 was found to be a risk factor for type-Ia endoleak (p = 0.059). GEN4 demonstrated a protective association regarding type-Ib endoleak (p = 0.012). Overall survival was 75.3%, 44.4%, 27.2%, and 17.6% at 1, 5, 10, and 15 years, respectively. Survival distinguished as non-related versus aortic-related was 86.7% vs 23.5%, 52.7% vs 9.8%, 32.9% vs 2.0%, 21.2% vs 0% at 1, 5, 10, and 15 years, respectively (p< 0.000). CONCLUSION: Endoleak occurred in a non-negligible percentage of TEVAR patients. A significant reduction of endoleak incidence over evolving stent-grafts generations was registered. Newer stent-graft generations demonstrated better long-term endoleak. Data about long-term outcomes require ongoing updates to prove both the reliability and the durability of newer stent-graft generations.

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.

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.

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

[This corrects the article DOI: 10.2196/16959.].

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.

Influence of Thoracic Endovascular Repair on Aortic Morphology in Patients Treated for Blunt Traumatic Aortic Injuries: Long Term Outcomes in a Multicentre Study.

OBJECTIVE: The aim of this study was to evaluate aortic remodelling and associated complications in patients treated by thoracic endovascular aneurysm repair (TEVAR) for blunt traumatic aortic injuries (BTAI). METHODS: This was a retrospective, observational, multicentre study. Remodelling was considered as aortic diameter variations of >2 mm and distal graft and aortic axis angle modification measured by computed tomography angiography (CTA). The predefined levels of measurement were the proximal end of the graft (D1: landing in zone [LZ] 2; D2: LZ 3); distal end (D3); and control measurement (D4) 15 mm beyond D3. Survival, procedure, graft, and/or radiation exposure related complications were registered. CTA was required within three months and at one, six, and 10 years post-operatively. RESULTS: Between 2004 and 2017 52 patients were treated; 47 were included for remodelling analysis (five immediate deaths were excluded); median age was 47 years (range 20-80 years). Mean TEVAR oversizing was 19.6% ± 9.7% (range 5%-35%). Following a median follow up of 67.4 ± 56.1 months (range 14-153 months) survival at one, three, six, and 10 years was 90.4% (standard error [SE] 4.1%), 88.3% (SE 4.5%) 84.8% (SE 5.5%), and 84.8% (SE 5.5%), respectively. There were no procedure/graft related complications except for one late intramural haematoma that required re-intervention. Freedom from aortic remodelling at one, six, and 10 years was 85.1% (SE 5.2%), 30.9% (SE 8.6%), and 24.7% (SE 8.8%), respectively. The increase in D1/D2 and D3 diameters were influenced by time from intervention (both p < .001), age (p < .001 and p = .002, respectively) and sealing in zone 2 (p = .027 and p = .042, respectively). For every 10% increase in oversizing, proximal neck diameter remodelling was 3.4% (p = .05). The distal axis decreased over time (p < .001; significant between three and six years). CONCLUSION: TEVAR is safe for BTAI in the mid to long term. This study reports a correlation between time, oversizing, and remodelling, but the level of adverse events was low.

Twenty years outcomes in a single center experience after endovascular aneurysm repair with unibody endograft and anatomical fixation.

BACKGROUND: To assess the long-term safety and effectiveness of endovascular aneurysm repair (EVAR) treatment with unibody endograft deployed on aortic bifurcation (anatomical fixation). METHODS: A retrospective, observational, single-center study of patients treated from 1999 to 2002 with unibody bifurcated endograft. Follow-up protocol required clinical and doppler-ultrasound at 1 and 6 months and annually thereafter, computed tomography angiography at 1-, 6- and 12-months and then every year. Primary endpoints included technical and treatment success, survival and freedom from late EVAR failure; secondary endpoints were freedom from late open conversion (LOC), freedom from late re-interventions and endoleaks. RESULTS: Seventy-three patients, mean age of 73±6 years were enrolled. Median follow-up was 6±0.5 years. Technical success was 98.6% (N.=71/73; causes of failure: 1 open conversion and 1 type Ib endoleak). A treatment success of 96% (N.=69/72) was recorded due to endoleaks (N.=2; 1 type Ia and 1 type Ib) and limb occlusion (N.=1). Survival at 1, 5, 10, 15 and 18 years was 90%, 58%, 40%, 32% and 23% respectively. One aneurysm-related death for infection of the endograft was registered. EVAR failure was 14% (N.=10/71). Three LOC were recorded and freedom from reinterventions at 1, 5, 10 and 18 years was 99%, 91%, 86% and 86%. Fourteen endoleaks were recorded: Ia (N.=6; 42.8%), Ia+Ib (N.=1; 7.1%), Ib (N.=2; 14.2%) and II (N.=5; 35.6%). Four endoleaks were observed, 9 endovascular correction and 1 LOC were required. Endoleaks free survival of 90% at 1-year and 75% at the end of the study. Aneurysm sac shrinkage was observed in 79% (N.=56/71). CONCLUSIONS: This small, retrospective cohort of anatomically fixed EVAR demonstrated long-term safety and effectiveness. The design of the unibody graft did not substantially change and newer generation should guarantee the same performance.

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.

Application of the EU-SILC 2011 data module "intergenerational transmission of disadvantage" to robust analysis of inequality of opportunity.

This data article describes the original data, the sample selection process and the variables used in Andreoli and Fusco (Andreoli and Fusco, 2019) to estimate gap curves for a sample of European countries. Raw data are from 2011 roaster of EU-SILC, cross-sectional sample of module "intergenerational transmission of disadvantage". This article reports descriptive statistics of the using sample. It also discusses the algorithm adopted to estimate the main effects and details the content of additional Stata files stored on the online repository. These additional files contain raw estimates from bootstrapped samples, which form the basis for estimating gap curves and their variance-covariance matrices. The data article also reports representations of gap curves for all 16 selected countries.

Endovascular aneurysm sealing with the Nellix endograft in hemodynamically-unstable ruptured abdominal aortic aneurysm with challenging anatomy.

BACKGROUND: To assess immediate and midterm outcomes of hemodynamically-unstable patients with ruptured abdominal aortic aneurysm (rAAA) treated with the Nellix endovascular sealing system (EVAS). METHODS: From June 2014 to June 2017, 21 hemodynamically-unstable rAAA patients with challenging anatomies were treated with EVAS. The mean AAA diameter and neck length measured 73±15 mm and 14±10 mm, respectively. All the patients presented an advance trauma life support (ATLS) hemorrhage class ≥1 confirming a compromised hemodynamic status. Primary endpoints include technical success, treatment success, primary safety and 30-day survival. Secondary endpoints include re-intervention rate and time free-from-reintervention. RESULTS: Technical success was achieved in 95% (N.=20/21); one patient was converted intraoperatively to open surgery due to ongoing hemorrhage. Seven re-interventions were performed within 30-days and one during the follow-up; treatment success rate of 67% and re-intervention rate of 33%. Early endoleaks were diagnosed in 5 patients (24%). Primary safety was 52%. After a mean follow-up of 11±10 months, survival rates were 81%, 62% and 57% at 1, 6 and 12 months, respectively. Time free-from-reintervention was 15±11 months. CONCLUSIONS: Emergency-EVAS (eEVAS) appeared feasible and useful, especially in hemodynamically-unstable patients with challenging anatomies. There are some limitations in this cohort study and larger, prospective and comparative studies are required to confirm eEVAS as part of an emergency treatment protocol for rAAA.

Experimental Study of Nonclassical Teleportation Beyond Average Fidelity.

Quantum teleportation establishes a correspondence between an entangled state shared by two separate parties that can communicate classically and the presence of a quantum channel connecting the two parties. The standard benchmark for quantum teleportation, based on the average fidelity between the input and output states, indicates that some entangled states do not lead to channels which can be certified to be quantum. It was recently shown that if one considers a finer-grained witness, then all entangled states can be certified to produce a nonclassical teleportation channel. Here we experimentally demonstrate a complete characterization of a new family of such witnesses, of the type proposed in Phys. Rev. Lett. 119, 110501 (2017)PRLTAO0031-900710.1103/PhysRevLett.119.110501 under different conditions of noise. We report nonclassical teleportation using quantum states that cannot achieve average fidelity of teleportation above the classical limit. We further use the violation of these witnesses to estimate the negativity of the shared state. Our results have fundamental implications in quantum information protocols and may also lead to new applications and quality certification of quantum technologies.

Inequality in old age cognition across the world.

Although cohort and country differences in average cognitive levels are well established, identifying the degree and determinants of inequalities in old age cognitive functioning could guide public health and policymaking efforts. We use all publicly available and representative old age surveys with comparable information to assess inequalities of cognitive functioning for six distinctive age groups in 29 countries. We document that cognitive inequalities in old age are largely determined by earlier educational inequalities as well as gender differential survival rates. For example, a one percentage point increase in the Gini index of past education is associated with an increase of 0.45 percentage points in the Gini index of delayed recall and 0.23 percentage points in the Gini of immediate recall. Results are robust to a variety of alternative explanations and persist even after controlling for gender-related biases in survival rates. Furthermore, we find evidence that unequal opportunities for education -captured by differences in parental background and gender- also have significant effects on inequality of old age cognition.