Prospective Study of the Iliac Branch Device E-liac in Patients with Common Iliac Artery Aneurysms: 12 Month Results.

OBJECTIVES: At 12 months follow up of the PLIANT study, clinical success and efficacy of the E-liac Stent Graft System (JOTEC GmbH, Hechingen, Germany) were evaluated. Clinical success was defined as aneurysm exclusion (no type I, III, IV endoleak) with primary patency of the internal iliac artery (IIA) and external iliac artery (EIA) on the E-liac implantation side. METHODS: In this prospective multicentre European observational study, clinical and morphological data of 45 patients (93% male, mean age 72 y) were prospectively collected in 11 European centres between July 2014 and June 2016. Forty patients underwent an aorto-iliac (three patients bilaterally) treatment and five an isolated iliac treatment. RESULTS: At 12 months follow up, data were available for 42 patients. Overall clinical success at 12 months was 90%, with a survival rate of 100%. Four patients (10%) did not achieve clinical success, one with an internal iliac artery (IIA) occlusion on the E-liac implantation side, one with an infrarenal type Ia endoleak, and two with type Ib endoleaks in IIA. At 12 months the primary patency rate in the internal iliac artery on the iliac side branch implantation side was 98%. Two patients (5%) received E-liac related re-interventions: one caused by an edge stenosis at the distal end of the graft limb in the external iliac artery (EIA) and one caused by thrombo-embolism in the external iliac artery. Thus, for the EIA, primary and secondary patency rates were 98% and 100%, respectively. CONCLUSIONS: The low device related re-intervention rate of 5%, the high survival rate of 100%, and the high primary patency rates of 98% for the IIA and EIA at 12 month follow up demonstrate the safety and efficacy of the E-liac Stent Graft System. Long term 36 month results are awaited to confirm the efficacy and durability.

Prospective study of the E-liac Stent Graft System in patients with common iliac artery aneurysms: 30-Day results.

OBJECTIVES: To study the safety and feasibility of the E-liac Stent Graft System® in patients with aorto/iliac aneurysms. METHODS: A prospective multicentric European registry of patients receiving the E-liac Stent Graft System® was conducted. Endpoints of the study included the technical success as well as periprocedural events and 30-day endoleaks, reinterventions, internal and external iliac artery patency and mortality. RESULTS: Between July 2014 and June 2016, a total of 45 patients (93% men, mean age 72 years, range 53-90 years) were enrolled at 11 sites in four European countries. Five patients received an isolated iliac treatment. Thirty-seven patients were treated with a combination of an abdominal stent graft and a unilateral E-liac and three in combination with bilateral E-liac. All E-liac Stent Grafts (48) were implanted in the intended position and the internal iliac arteries were successfully bridged. Two patients did not receive clinical success, due to endoleak type Ia of the aortic stent graft. At 30-day follow-up, clinical success rate was 96%. Three successful endovascular reinterventions were performed within the 30-day follow-up: one due to a type Ia endoleak in the common iliac artery, one due to type Ia endoleak of the aortic stent graft, and one due to bilateral lower limb claudication provoked by stent graft limb stenosis. At 30-day, a 100% survival rate and complete absence of pelvic or buttock ischemia/claudication were reported. Primary patency at 30 days was 100% for the internal iliac artery and 98% for the external iliac artery with an assisted patency of 100% in the latter. CONCLUSIONS: The high clinical success rate, low rates of device-related reinterventions (2%), and excellent patency rate demonstrate the safety and feasibility of the E-liac Stent Graft System. Long-term results are awaited to state efficacy and durability. Clinical Trials.gov. Identifier no. NCT02209194.

Pulmonary functional imaging: qualitative comparison of Fourier decomposition MR imaging with SPECT/CT in porcine lung.

PURPOSE: To compare unenhanced lung ventilation-weighted (VW) and perfusion-weighted (QW) imaging based on Fourier decomposition (FD) magnetic resonance (MR) imaging with the clinical reference standard single photon emission computed tomography (SPECT)/computed tomography (CT) in an animal experiment. MATERIALS AND METHODS: The study was approved by the local animal care committee. Lung ventilation and perfusion was assessed in seven anesthetized pigs by using a 1.5-T MR imager and SPECT/CT. For time-resolved FD MR imaging, sets of lung images were acquired by using an untriggered two-dimensional balanced steady-state free precession sequence (repetition time, 1.9 msec; echo time, 0.8 msec; acquisition time per image, 118 msec; acquisition rate, 3.33 images per second; flip angle, 75°; section thickness, 12 mm; matrix, 128 × 128). Breathing displacement was corrected with nonrigid image registration. Parenchymal signal intensity was analyzed pixelwise with FD to separate periodic changes of proton density induced by respiration and periodic changes of blood flow. Spectral lines representing respiratory and cardiac frequencies were integrated to calculate VW and QW images. Ventilation and perfusion SPECT was performed after inhalation of dispersed technetium 99m ((99m)Tc) and injection of (99m)Tc-labeled macroaggregated albumin. FD MR imaging and SPECT data were independently analyzed by two physicians in consensus. A regional statistical analysis of homogeneity and pathologic signal changes was performed. RESULTS: Images acquired in healthy animals by using FD MR imaging and SPECT showed a homogeneous distribution of VW and QW imaging and pulmonary ventilation and perfusion, respectively. The gravitation-dependent signal distribution of ventilation and perfusion in all animals was similarly observed at FD MR imaging and SPECT. Incidental ventilation and perfusion defects were identically visualized by using both modalities. CONCLUSION: This animal experiment demonstrated qualitative agreement in the assessment of regional lung ventilation and perfusion between contrast media-free and radiation-free FD MR imaging and conventional SPECT/CT.

Non-contrast-enhanced magnetic resonance imaging for visualization and quantification of endovascular aortic prosthesis, their endoleaks and aneurysm sacs at 1.5 T.

PURPOSE: After an endovascular aortic aneurysm repair (EVAR), a follow-up at 1, 6 and every 12 months is recommended for remainder of the patient's life. The diagnostic standard methods for diagnosing endoleaks and visualization of aneurysms in EVAR-patients are: invasive digital subtraction angiography (DSA), contrast enhanced (CE) computed tomographic angiography (CE-CTA), and magnetic resonance angiography (CE-MRA). These techniques, however, require the use of iodine- or gadolinium-based contrast agents with rare, but possibly life threatening side effects such as renal impairment, thyrotoxicosis and allergic reactions, nephrogenic systemic fibrosis, and cerebral gadolinium deposition. The aim of this prospective study was to compare a non-contrast-enhanced MRI protocol (consist of four MRI methods) with DSA and CE-CTA for visualization and quantification of endovascular aortic prosthesis, their endoleaks and aneurysms. MATERIAL AND METHODS: Eight patients (mean age 76.8 ±â€¯4.9 years, 63% male), whose thoracic, abdominal, or iliac aneurysms were treated with different endovascular prosthesis and suffered from type I-V endoleaks, were examined on a 1.5 Tesla MR system. Quiescent-interval slice selective MR angiography (QISS-MRA), 4-dimensional (4D)-flow MRI, T1- and T2-mapping, as well as DSA and CE-CTA were used for the visualization and quantification of endoprosthesis, endoleaks, and aneurysms in these patients. RESULTS: QISS-MRA provided good visualization of endoleaks and comparable quantification of aneurysm size with respect to CE-CTA and DSA. The 4D-flow MRI provided additional information about the wall shear stress, which could not be determined using DSA. In contrast to CE-CTA, T1- and T2-mapping provided detailed information about heterogeneous areas within an aneurysm sac. CONCLUSIONS: Compared to DSA and CE-CTA, the proposed MRI methods provide improved anatomical and functional information for various types of endoprostheses and endoleaks. In addition, hemodynamic parameters of the aorta and information on the content of aneurysm sac are provided as well. Within the frame of personalized medicine, the personalized diagnosis enabled by this non-CE MRI protocol is the foundation for a personalized and successful treatment.