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

The RING GPS network: a research geodetic infrastructure to study plate boundary deformation in the Central Mediterranean

We present the INGV (Italian National Institute of Geophysics and Volcanology) geodetic research infrastructure and related facilities, dedicated to the observation and monitoring of current deformation of the plate boundary between Africa and Eurasia. The recent increase of continuous GPS (CGPS) stations in the Central Mediterranean plate boundary zone offers the opportunity to study in detail the present-day kinematics of this actively deforming region. For answering all the open questions related to this complex area, INGV deployed a permanent, integrated and real-time monitoring CGPS network (RING) all over Italy. The RING network (http:/ring.gm.ingv.it) is now constituted by more than 150 stations. All stations have high quality GPS monuments and most of them are co-located with broadband or very broadband seismometers and strong motion sensors. The RING CGPS sites acquire at 1Hz and 30s sampling rates (some of them acquire at 10 Hz) and are connected in real-time to the INGV acquisition centers located in Roma and Grottaminarda. Real-time GPS data are transmitted using different systems, such as satellite systems, Internet, GPRS/UMTS and wireless networks. The differentiation of data transmission type and the integration with seismic instruments makes this network one of the most innovative CGPS networks in Europe. Furthermore, the INGV data acquisition centers acquire, archive and analyze most of the Italian CGPS stations managed by regional or national data providers (such as local Authorities and nation-wide industries), integrating more than 350 stations of the CGPS scientific and commercial networks existing in the Italian region. To manage data acquisition, storage, distribution and access we developed dedicated facilities including new softwares for data acquisition and a web-based collaborative environment for management of data and metadata. The GPS analysis is carried out with the three main geodetic-quality softwares used in the GPS scientific community: Bernese GAMIT an GIPSY-OASIS. The resulting daily solutions are aligned to the ITRF2005 reference frame. Stable plate reference frames are realized by minimizing the horizontal velocities at sites on the Eurasia and Nubia plates, respectively. The different software-related solutions consistency RMS is within 0.3 mm/yr (Avallone et al., 2010). The solutions are then evaluated with regard to the numerous scientific motivations behind this presentation, ranging from the definition of strain distribution and microplate kinematics within the plate boundary, to the evaluation of tectonic strain accumulation on active faults. The RING network is strongly contributing to the definition of GPS velocity field in the Italian region, and now is able to furnish a newly and up to date view of this actively deforming part of the Nubia-Eurasia plate boundary. INGV is now aiming to make the RING (and integrated CGPS networks) data and related products publicly available for the scientific community. We believe that our network represents an important reality in the framework of the EPOS infrastructure and we strongly support the idea of an European research approach to data sharing among the scientific community. We will present (a) the current CGPS site distribution, (b) the technological description of the data acquisition, storage and distribution at INGV centers, (c) the results of CGPS data analysis, and (d) the planned data access for the scientific community.PublishedVienna, Geophysical Research Abstracts Vol. 13, EGU2011-8626, 20111.9. Rete GPS nazionale3.2. Tettonica attivaope

The RING GPS network: a research geodetic infrastructure to study plate boundary deformation in the Central Mediterranean

We present the INGV (Italian National Institute of Geophysics and Volcanology) geodetic research infrastructure and related facilities, dedicated to the observation and monitoring of current deformation of the plate boundary between Africa and Eurasia. The recent increase of continuous GPS (CGPS) stations in the Central Mediterranean plate boundary zone offers the opportunity to study in detail the present-day kinematics of this actively deforming region. For answering all the open questions related to this complex area, INGV deployed a permanent, integrated and real-time monitoring CGPS network (RING) all over Italy. The RING network (http:/ring.gm.ingv.it) is now constituted by more than 150 stations. All stations have high quality GPS monuments and most of them are co-located with broadband or very broadband seismometers and strong motion sensors. The RING CGPS sites acquire at 1Hz and 30s sampling rates (some of them acquire at 10 Hz) and are connected in real-time to the INGV acquisition centers located in Roma and Grottaminarda. Real-time GPS data are transmitted using different systems, such as satellite systems, Internet, GPRS/UMTS and wireless networks. The differentiation of data transmission type and the integration with seismic instruments makes this network one of the most innovative CGPS networks in Europe. Furthermore, the INGV data acquisition centers acquire, archive and analyze most of the Italian CGPS stations managed by regional or national data providers (such as local Authorities and nation-wide industries), integrating more than 350 stations of the CGPS scientific and commercial networks existing in the Italian region. To manage data acquisition, storage, distribution and access we developed dedicated facilities including new softwares for data acquisition and a web-based collaborative environment for management of data and metadata. The GPS analysis is carried out with the three main geodetic-quality softwares used in the GPS scientific community: Bernese GAMIT an GIPSY-OASIS. The resulting daily solutions are aligned to the ITRF2005 reference frame. Stable plate reference frames are realized by minimizing the horizontal velocities at sites on the Eurasia and Nubia plates, respectively. The different software-related solutions consistency RMS is within 0.3 mm/yr (Avallone et al., 2010). The solutions are then evaluated with regard to the numerous scientific motivations behind this presentation, ranging from the definition of strain distribution and microplate kinematics within the plate boundary, to the evaluation of tectonic strain accumulation on active faults. The RING network is strongly contributing to the definition of GPS velocity field in the Italian region, and now is able to furnish a newly and up to date view of this actively deforming part of the Nubia-Eurasia plate boundary. INGV is now aiming to make the RING (and integrated CGPS networks) data and related products publicly available for the scientific community. We believe that our network represents an important reality in the framework of the EPOS infrastructure and we strongly support the idea of an European research approach to data sharing among the scientific community. We will present (a) the current CGPS site distribution, (b) the technological description of the data acquisition, storage and distribution at INGV centers, (c) the results of CGPS data analysis, and (d) the planned data access for the scientific community

Guidelines on the diagnosis, treatment and management of visceral and renal arteries aneurysms: a joint assessment by the Italian Societies of Vascular and Endovascular Surgery (SICVE) and Medical and Interventional Radiology (SIRM)

: The objective of these Guidelines is to provide recommendations for the classification, indication, treatment and management of patients suffering from aneurysmal pathology of the visceral and renal arteries. The methodology applied was the GRADE-SIGN version, and followed the instructions of the AGREE quality of reporting checklist. Clinical questions, structured according to the PICO (Population, Intervention, Comparator, Outcome) model, were formulated, and systematic literature reviews were carried out according to them. Selected articles were evaluated through specific methodological checklists. Considered Judgments were compiled for each clinical question in which the characteristics of the body of available evidence were evaluated in order to establish recommendations. Overall, 79 clinical practice recommendations were proposed. Indications for treatment and therapeutic options were discussed for each arterial district, as well as follow-up and medical management, in both candidate patients for conservative therapy and patients who underwent treatment. The recommendations provided by these guidelines simplify and improve decision-making processes and diagnostic-therapeutic pathways of patients with visceral and renal arteries aneurysms. Their widespread use is recommended

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

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