Device innovation in cardiovascular medicine: a report from the European Society of Cardiology Cardiovascular Round Table.

Research performed in Europe has driven cardiovascular device innovation. This includes, but is not limited to, percutaneous coronary intervention, cardiac imaging, transcatheter heart valve implantation, and device therapy of cardiac arrhythmias and heart failure. An important part of future medical progress involves the evolution of medical technology and the ongoing development of artificial intelligence and machine learning. There is a need to foster an environment conducive to medical technology development and validation so that Europe can continue to play a major role in device innovation while providing high standards of safety. This paper summarizes viewpoints on the topic of device innovation in cardiovascular medicine at the European Society of Cardiology Cardiovascular Round Table, a strategic forum for high-level dialogue to discuss issues related to the future of cardiovascular health in Europe. Devices are developed and improved through an iterative process throughout their lifecycle. Early feasibility studies demonstrate proof of concept and help to optimize the design of a device. If successful, this should ideally be followed by randomized clinical trials comparing novel devices vs. accepted standards of care when available and the collection of post-market real-world evidence through registries. Unfortunately, standardized procedures for feasibility studies across various device categories have not yet been implemented in Europe. Cardiovascular imaging can be used to diagnose and characterize patients for interventions to improve procedural results and to monitor devices long term after implantation. Randomized clinical trials often use cardiac imaging-based inclusion criteria, while less frequently trials randomize patients to compare the diagnostic or prognostic value of different modalities. Applications using machine learning are increasingly important, but specific regulatory standards and pathways remain in development in both Europe and the USA. Standards are also needed for smart devices and digital technologies that support device-driven biomonitoring. Changes in device regulation introduced by the European Union aim to improve clinical evidence, transparency, and safety, but they may impact the speed of innovation, access, and availability. Device development programmes including dialogue on unmet needs and advice on study designs must be driven by a community of physicians, trialists, patients, regulators, payers, and industry to ensure that patients have access to innovative care.

Ultrasound-MR fusion imaging combined with intraductal cooling via PTCD during microwave ablation of perihilar liver tumors: a retrospective pilot study.

PURPOSE: To explore the feasibility and safety of a microwave ablation (MWA) strategy involving intraductal chilled saline perfusion (ICSP) via percutaneous transhepatic cholangial drainage (PTCD) combined with ultrasound-magnetic resonance (US-MR) fusion imaging for liver tumors proximal to the hilar bile ducts (HBDs). METHODS: Patients with liver tumors proximal to the HBDs (≤5 mm) who underwent MWA at our hospital between June 2020 and April 2023 were retrospectively analyzed. The strategy of US-MR fusion imaging combined with PTCD-ICSP was used to assist the MWA procedures. The technical success, technique efficacy, local tumor progression, intrahepatic distant recurrence and complications were recorded and analyzed. RESULTS: In total, 12 patients with 12 liver tumors were retrospectively enrolled in this study. US-MR fusion imaging was utilized in all patients, and PTCD-ICSP assistance was successfully used for 4 nodules abutting HBDs (0 mm). The rates of technical success, technique efficacy, local tumor progression and intrahepatic distant recurrence were 91.7%, 83.3%, 0% and 8.3%, respectively. The major complication of biliary infection occurred in only one patient who had previously undergone left hemihepatectomy and bile-intestinal anastomosis. CONCLUSIONS: MWA for liver tumors proximal to HBDs assisted by US-MR fusion imaging combined with PTCD-ICSP was feasible and safe. This strategy made MWA of liver tumors abutting HBDs possible.

Use of fusion imaging in safe, rapid, and accurate placement of percutaneous right ventricular assist device in the management of acute post-surgical right ventricular failure.

Fusion imaging (FI) technology using EchoNavigator that integrates live transesophageal echocardiogram and overlays on real-time fluoroscopy. We present our experience placing a right ventricular (RV) support device, a ProtekDuo, in our patient with post-operative RV failure using FI to guide the implantation.

Comparative study of CTA/CTV and MRTA for preoperative simulation of microvascular decompression in neurovascular compression syndromes.

Neurovascular compression syndrome (NVCS), characterized by cranial nerve compression due to adjacent blood vessels at the root entry zone, frequently presents as trigeminal neuralgia (TN), hemifacial spasm (HFS), or glossopharyngeal neuralgia (GN). Despite its prevalence in NVCS assessment, Magnetic Resonance Tomographic Angiography (MRTA)'s limited sensitivity to small vessels and veins poses challenges. This study aims to refine vessel localization and surgical planning for NVCS patients using a novel 3D multimodal fusion imaging (MFI) technique incorporating computed tomography angiography and venography (CTA/CTV). A retrospective analysis was conducted on 76 patients who underwent MVD surgery and were diagnosed with single-site primary TN, HFS, or GN. Imaging was obtained from MRTA and CTA/CTV sequences, followed by image processing and 3D-MFI using FastSurfer and 3DSlicer. The CTA/CTV-3D-MFI showed higher sensitivity than MRTA-3D-MFI in predicting responsible vessels (98.6% vs. 94.6%) and NVC severity (98.6% vs. 90.8%). Kappa coefficients revealed strong agreement with MRTA-3D-MFI (0.855 for vessels, 0.835 for NVC severity) and excellent agreement with CTA/CTV-3D-MFI (0.951 for vessels, 0.952 for NVC). Resident neurosurgeons significantly preferred CTA/CTV-3D-MFI due to its better correlation with surgical reality, clearer depiction of surgical anatomy, and optimized visualization of approaches (p < 0.001). Implementing CTA/CTV-3D-MFI significantly enhanced diagnostic accuracy and surgical planning for NVCS, outperforming MRTA-3D-MFI in identifying responsible vessels and assessing NVC severity. This innovative imaging modality can potentially improve outcomes by guiding safer and more targeted surgeries, particularly in cases where MRTA may not adequately visualize crucial neurovascular structures.

Fusion imaging for guidance of pulmonary arteriovenous malformation embolisation with minimal radiation and contrast exposure.

Hereditary haemorrhagic telangiectasia is an inherited disorder characterised by vascular dysplasia that leads to the development of arteriovenous malformations. Pulmonary arteriovenous malformations occur in approximately 30% of patients with haemorrhagic telangiectasia. Given the complex characteristics of haemorrhagic telangiectasia lesions, the application of three-dimensional fusion imaging holds significant promise for procedural guidance and decrease in contrast and radiation dosing. We reviewed all patients who underwent transcatheter approach for pulmonary arteriovenous malformation occlusion with fusion image guidance from June 2018 to September 2023 from a single centre. A total of nine cases with haemorrhagic telangiectasia and transcatheter occlusion of pulmonary arteriovenous malformations using fusion imaging were identified. Five (56%) were male, mean age at procedure was 15.7 years (10-28 years) and mean number of pulmonary arteriovenous malformations intervened was three per patient (1-7). Two of the cases were complex repeat embolisations. The mean fluoroscopy time was 40.6 min (10.7-68.8 min), with mean contrast dose of 28.8 mL (11-60 mL; mean of 0.51 mL/kg) and mean radiation dose of 66.3 mGy (25.6-140 mGy; mean of 40.5 mGy/m2). There were no complications reported during the procedures, with no additional interventions necessary. Fusion imaging in pulmonary arteriovenous malformations embolisation for patients with haemorrhagic telangiectasia is feasible and has the potential to reduce contrast and radiation doses. To our knowledge, we describe the lowest radiation and contrast doses per patient using fusion imaging technology reported in the literature to date.

Is 3T MR nerve-bone fusion imaging a viable alternative to MRI-CBCT to identify the relationship between the inferior alveolar nerve and mandibular third molar.

OBJECTIVES: To investigate the feasibility of MRI nerve-bone fusion imaging in assessing the relationship between inferior alveolar nerve (IAN) / mandibular canal (MC) and mandibular third molar (MTM) compared with MRI-CBCT fusion. MATERIALS AND METHODS: The MRI nerve-bone fusion and MRI-CBCT fusion imaging were performed in 20 subjects with 37 MTMs. The Hausdorff distance (HD) value and dice similarity coefficient (DSC) was calculated. The relationship between IAN/MC and MTM roots, inflammatory, and fusion patterns were compared between these two fused images. The reliability was assessed using a weighted κ statistic. RESULTS: The mean HD and DSC ranged from 0.62 ~ 1.35 and 0.83 ~ 0.88 for MRI nerve-bone fusion, 0.98 ~ 1.50 and 0.76 ~ 0.83 for MRI-CBCT fusion. MR nerve-bone fusion had considerable reproducibility compared to MRI-CBCT fusion in relation classification (MR nerve-bone fusion κ = 0.694, MRI-CBCT fusion κ = 0.644), direct contact (MR nerve-bone fusion κ = 0.729, MRI-CBCT fusion κ = 0.720), and moderate to good agreement for inflammation detection (MR nerve-bone fusion κ = 0.603, MRI-CBCT fusion κ = 0.532, average). The MR nerve-bone fusion imaging showed a lower ratio of larger pattern compared to MR-CBCT fusion (16.2% VS 27.3% in the molar region, and 2.7% VS 5.4% in the retromolar region). And the average time spent on MR nerve-bone fusion and MRI-CBCT fusion was 1 min and 3 min, respectively. CONCLUSIONS: Both MR nerve-bone fusion and MRI-CBCT fusion exhibited good consistency in evaluating the spatial relationship between IAN/MC and MTM, fusion effect, and inflammation detection. CLINICAL RELEVANCE: MR nerve-bone fusion imaging can be a preoperative one-stop radiation-free examination for patients at high risk for MTM surgery.

Cloud-based fusion imaging improves operative metrics during fenestrated endovascular aneurysm repair.

OBJECTIVE: Endovascular treatment of complex aortic pathology has been associated with increases in procedural-related metrics, including the operative time and radiation exposure. Three-dimensional fusion imaging technology has decreased the radiation dose and iodinated contrast use during endovascular aneurysm repair. The aim of the present study was to report our institutional experience with the use of a cloud-based fusion imaging platform during fenestrated endovascular aneurysm repair (FEVAR). METHODS: A retrospective review of a prospectively maintained aortic database was performed to identify all patients who had undergone FEVAR with commercially available devices (Zenith Fenestrated; Cook Medical Inc, Bloomington, IN) between 2013 and 2020 and all endovascular aneurysm repairs performed using Cydar EV Intelligent Maps (Cydar Medical, Cambridge, UK). The Cydar EV cohort was reviewed further to select all FEVARs performed with overlay map guidance. The patient demographic, clinical, and procedure metrics were analyzed, with a comparative analysis of FEVAR performed without and with the Cydar EV imaging platform. Patients were excluded from comparative analysis if the data were incomplete in the dataset or they had a documented history of prior open or endovascular abdominal aortic aneurysm repair. RESULTS: During the 7-year study period, 191 FEVARs had been performed. The Cydar EV imaging platform was implemented in 2018 and used in 124 complex endovascular aneurysm repairs, including 69 consecutive FEVARs. A complete dataset was available for 137 FEVARs. With exclusion to select for de novo FEVAR, a comparative analysis was performed of 53 FEVAR without and 63 with Cydar EV imaging guidance. The cohorts were similar in patient demographics, medical comorbidities, and aortic aneurysm characteristics. No significant difference was noted between the two groups for major adverse postoperative events, length of stay, or length of intensive care unit stay. The use of Cydar EV resulted in nonsignificant decreases in the mean fluoroscopy time (69.3 ± 28 minutes vs 66.2 ± 33 minutes; P = .598) and operative time (204.4 ± 64 minutes vs 186 ± 105 minutes; P = .278). A statistically significant decrease was found in the iodinated contrast volume (105 ± 44 mL vs 83 ± 32 mL; P = .005), patient radiation exposure using the dose area product (1,049,841 mGy/cm2 vs 630,990 mGy/cm2; P < .001) and cumulative air kerma levels (4518 mGy vs 3084 mGy; P = .02) for patients undergoing FEVAR with Cydar EV guidance. CONCLUSIONS: At our aortic center, we have observed a trend toward shorter operative times and significant reductions in both iodinated contrast use and radiation exposure during FEVAR using the Cydar EV intelligent maps. Intelligent map guidance improved the efficiency of complex endovascular aneurysm repair, providing a safer intervention for both patient and practitioner.

Fusion imaging-guided radiofrequency ablation with artificial ascites or pleural effusion in patients with hepatocellular carcinomas: the feasibility rate and mid-term outcome.

Purpose: To investigate the feasibility rate and the mid-term outcomes of fusion imaging-guided radiofrequency ablation (RFA) with artificial ascites or pleural effusion of hepatocellular carcinomas (HCCs) based on tumor locations.Materials and Methods: In this single-center retrospective study, 456 patients with single HCCs ≤4 cm were referred for RFA from April 2019 to April 2020. The tumor locations were classified into a conventional location (CL) and difficult location (DL, close to the diaphragm/heart/major vessels/bile ducts/gastrointestinal tract/kidneys). This study assessed the feasibility rate of CT/MRI-US fusion system-guided RFA with artificial ascites or pleural effusion and the therapeutic outcomes including technical success, technique efficacy, and local tumor progression (LTP) according to tumor location. Cumulative LTP rates were estimated using the Kaplan-Meier method.Results: 235 of 456 (51.5%) patients had HCCs in DL. Ablation was feasible in 431 of 456 (94.5%) patients. The feasibility rate was significantly lower in DL group than in CL group (89.8% [211/235] vs. 99.5% [220/221], p < 0.001). The technical success and technique efficacy rates were 100% [211/211] vs. 99.5% [219/220] and 98.6% [208/211] vs. 100% [220/220] in DL and CL groups, respectively (p > 0.05). The estimated 1-, 2-, and 3-year cumulative LTP rates in DL group were 1.0%, 2.5%, and 2.5%, respectively, and were not significantly different from the 2.3%, 3.9%, and 3.9% observed in CL group (p = 0.456).Conclusion: Fusion imaging-guided RFA with artificial ascites or pleural effusion could decrease technically infeasible cases and provide comparable LTP rates for HCCs in DL to HCCs in CL.

3D color multimodality fusion imaging as an augmented reality educational and surgical planning tool for extracerebral tumors.

Extracerebral tumors often occur on the surface of the brain or at the skull base. It is important to identify the peritumoral sulci, gyri, and nerve fibers. Preoperative visualization of three-dimensional (3D) multimodal fusion imaging (MFI) is crucial for surgery. However, the traditional 3D-MFI brain models are homochromatic and do not allow easy identification of anatomical functional areas. In this study, 33 patients with extracerebral tumors without peritumoral edema were retrospectively recruited. They underwent 3D T1-weighted MRI, diffusion tensor imaging (DTI), and CT angiography (CTA) sequence scans. 3DSlicer, Freesurfer, and BrainSuite were used to explore 3D-color-MFI and preoperative planning. To determine the effectiveness of 3D-color-MFI as an augmented reality (AR) teaching tool for neurosurgeons and as a patient education and communication tool, questionnaires were administered to 15 neurosurgery residents and all patients, respectively. For neurosurgical residents, 3D-color-MFI provided a better understanding of surgical anatomy and more efficient techniques for removing extracerebral tumors than traditional 3D-MFI (P < 0.001). For patients, the use of 3D-color MFI can significantly improve their understanding of the surgical approach and risks (P < 0.005). 3D-color-MFI is a promising AR tool for extracerebral tumors and is more useful for learning surgical anatomy, developing surgical strategies, and improving communication with patients.

Small Zoom Mismatch Adjustment Method for Dual-Band Fusion Imaging System Based on Edge-Gradient Normalized Mutual Information.

Currently, automatic optical zoom setups are being extensively explored for their applications in search, detection, recognition, and tracking. In visible and infrared fusion imaging systems with continuous zoom, dual-channel multi-sensor field-of-view matching control in the process of synchronous continuous zoom can be achieved by pre-calibration. However, mechanical and transmission errors of the zoom mechanism produce a small mismatch in the field of view after co-zooming, degrading the sharpness of the fusion image. Therefore, a dynamic small-mismatch detection method is necessary. This paper presents the use of edge-gradient normalized mutual information as an evaluation function of multi-sensor field-of-view matching similarity to guide the small zoom of the visible lens after continuous co-zoom and ultimately reduce the field-of-view mismatch. In addition, we demonstrate the use of the improved hill-climbing search algorithm for autozoom to obtain the maximum value of the evaluation function. Consequently, the results validate the correctness and effectiveness of the proposed method under small changes in the field of view. Therefore, this study is expected to contribute to the improvement of visible and infrared fusion imaging systems with continuous zoom, thereby enhancing the overall working of helicopter electro-optical pods, and early warning equipment.

Ultrasound fusion imaging for improving diagnostic and therapeutic strategies of focal liver lesions: A preliminary study.

PURPOSE: To assess the effect of ultrasound (US) fusion imaging on the clinical diagnostic and therapeutic strategies of focal liver lesions, which are difficult to detect or diagnose by conventional US. METHODS: From November 2019 to June 2022, 71 patients with invisible or undiagnosed focal liver lesions who underwent fusion imaging combining US with CT or MR were included in this retrospective study. The reasons for US fusion imaging were as follows: (1) lesions that were undetectable or inconspicuous on B-mode US; (2) post-ablation lesions that could not be assessed accurately by B-mode US; (3) to evaluate whether the lesions detected by B-mode US that were consistent with those presented on MRI/CT images. RESULTS: Of the 71 cases, 43 cases were single lesions, and 28 cases were multiple lesions. Among the 46 cases which were invisible on conventional US, the display rate of lesions using US-CT/MRI fusion imaging was 30.8%, and that combined with CEUS was 76.9%. US-guided biopsy was performed in 30 patients after the detection and localization determined by fusion imaging, with a positive rate of 73.3%. Six patients with recurrence after ablation therapy were all detected and located accurately after fusion imaging, and 4 of them successfully underwent ablation therapy again. CONCLUSION: Fusion imaging contributes to the understanding of the anatomical relationship between lesion location and blood vessels. Additionally, fusion imaging can improve the diagnostic confidence, be helpful to guide interventional operations, and hence be conducive to clinical therapeutic strategies.

Evaluation of Surgical Indications for Full Endoscopic Discectomy at Lumbosacral Disc Levels Using Three-Dimensional Magnetic Resonance/Computed Tomography Fusion Images Created with Artificial Intelligence.

Background and Objectives: Although full endoscopic lumbar discectomy with the transforaminal approach (FED-TF) is a minimally invasive spinal surgery for lumbar disc herniation, the lumbosacral levels present anatomical challenges when performing FED-TF surgery due to the presence of the iliac bone. Materials and Methods: In this study, we simulated whether FED-TF surgery could be safely performed on a total of 52 consecutive cases with L5-S1 or L5-L6 disc herniation using fused three-dimensional (3D) images of the lumbar nerve root on magnetic resonance imaging (MRI) created with artificial intelligence and of the lumbosacral spine and iliac on computed tomography (CT) images. Results: Thirteen of the fifty-two cases were deemed operable according to simulated FED-TF surgery without foraminoplasty using the 3D MRI/CT fusion images. All 13 cases underwent FED-TF surgery without neurological complications, and their clinical symptoms significantly improved. Conclusions: Three-dimensional simulation may allow for the assessment from multiple angles of the endoscope entry and path, as well as the insertion angle. FED-TF surgery simulation using 3D MRI/CT fusion images could be useful in determining the indications for full endoscopic surgery for lumbosacral disc herniation.

EndoNaut two-dimensional fusion imaging with a mobile C-arm for endovascular treatment of occlusive peripheral arterial disease.

BACKGROUND: Endovascular treatment has become the first-line strategy for peripheral arterial disease (PAD). Given the number of procedures required, any technology associated with a reduction in radiation exposure and contrast volume is highly relevant. In the present study, we evaluated whether two-dimensional (2D) fusion imaging could reduce the radiation exposure and contrast volume during endovascular treatment of occlusive PAD. METHODS: Our consecutive, retrospective, single-center, nonrandomized comparative trial included patients with PAD at the femoral, popliteal, and/or tibial level, at any clinical stage, if they were candidates for endovascular revascularization. Patients were treated with or without the EndoNaut 2D fusion imaging system (Therenva, Rennes, France) in a nonhybrid room with the same Cios Alpha mobile C-arm (Siemens, Munich, Germany). The indirect dose-area product and contrast medium volume were recorded. RESULTS: Between March 2018 and April 2020, 255 patients underwent endovascular femoropopliteal revascularization with (n = 124) or without (n = 131) 2D fusion imaging. The volume of injected contrast medium (34.7 ± 13.8 mL vs 51.3 ± 26.7 mL; P < .001) and dose-area product (8.9 ± 9.9 Gy/cm2 vs 13.5 ± 14.0 Gy/cm2; P = .003) were significantly lower for the 2D fusion imaging group than for the control group. A subgroup analysis of complex (TransAtlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease C/D) lesions showed similar results. Stratification of the fusion imaging group into three subgroups, according to the procedure dates, showed no effect of a potential learning curve on the operative parameters. CONCLUSIONS: The results from the present study showed a significant reduction in the contrast volume and radiation dose for endovascular treatment of PAD when applying 2D fusion imaging technology. Overall, a reduction of >30% was observed for both operative parameters, without excessive training requirements, highlighting the potential benefits of using 2D fusion imaging when performing endovascular revascularization for PAD.

Fusion imaging guidance for endovascular recanalization of peripheral occlusive disease.

OBJECTIVE: Endovascular procedures are now the first line option for treatment of lower extremity arterial disease. Fusion imaging guidance has been reported to reduce radiation exposure and reintervention rates during fenestrated and branched endovascular repairs, but limited literature exists on its benefits during lower extremity arterial disease endovascular procedures, and more specifically peripheral occlusive disease (POD). This study aims to evaluate the radiation exposure and technical success benefits of fusion imaging guidance in a large cohort of patients treated endovascularly for complex POD. METHODS: From January 2017 to September 2019, in a single center, all consecutive patients presenting symptomatic occlusions (Rutherford Baker categories 3 to 6) in the setting of POD and treated endovascularly were retrospectively assessed for inclusion. All procedures were performed under augmented fluoroscopy guidance (Vessel ASSIST, GE Healthcare), overlaying on live imaging the 3D path for transluminal recanalization based on the preoperative computed tomography angiography. Technical success, dose area product (DAP), total cumulated air kerma (CAK), and fluoroscopy time were collected. DAP results were compared with the literature. RESULTS: During the study period, 179 patients were treated for iliac (n = 56) or femoropopliteal (n = 123) symptomatic arterial occlusions. Technical success was reported in 171 of 179 procedures (95.5%). The use of a re-entry catheter was required to achieve technical success in 11 patients (6.1%). Mean DAP and CAK were 12.70 Gy·cm2 and 135 mGy, respectively, with a mean fluoroscopy time of 15.26 minutes. DAP and CAK were significantly higher in the iliac group when compared with the femoropopliteal group, although fluoroscopy time was not significantly different. DAP was lower than levels reported in the literature. CONCLUSIONS: Routine use of fusion imaging guidance during POD endovascular treatment is associated with low radiation exposure, high technical success, and reduced need for re-entry systems.

Fusion Imaging Guidance Does Not Affect Radiation Exposure During Endovascular Procedures for Lower Extremity Arterial Disease: A Randomized Controlled Trial.

PURPOSE: Radiation exposure for vascular interventionalists is still a concern. The aim of this study was to assess the value of advanced imaging guidance on radiation exposure and iodinated contrast volume during endovascular treatment of lower extremity arterial disease (LEAD). MATERIALS AND METHODS: It was a prospective, randomized, monocentric, pilot, single-operator study, conducted from June 2018 to October 2019. Consecutive patients requiring a preoperative computed tomography angiography (CTA) for a symptomatic LEAD and scheduled for an iliac and/or femoropopliteal endovascular repair in a hybrid room were included. Patients were randomly assigned to the use of fusion imaging guidance (Vessel Navigator®, Philips) or not. The primary endpoint was the dose area product (DAP, Gy.cm²). Secondary endpoints were DAP for fluoroscopy, DAP for fluorography, Air Kerma, fluoroscopy time, volume of contrast, and number of digital subtraction angiography (DSA). Data were expressed in median [Q1-Q3]. RESULTS: In all, 64 of the 77 patients enrolled (34 in fusion group, 30 in control group, 82% men, 65.8 years [61-71]) were included. Groups were similar in terms of comorbidities, BMI (26 kg/cm2 [24-28]), but lesion location were not equally distributed (p=0.004). There was no significant difference between the groups regarding DAP (31.6 Gy.cm2 [23.4; 46.9] for fusion group vs 25.6[16.9; 34.0] Gy.cm2; p=0.07), Air Kerma (160 mGy [96;3365] vs 115 mGy [76;201]; p=0.12, fluoroscopy time (560 seconds [326;960] vs 454 seconds [228;1022]; p=0.44), contrast volume (60 ml [42;80] vs 50 ml [40;66]; p=0.10), or operative time (68 minutes [55;90] vs 46 minutes [30;80]; p=0.06). The median number of DSA was 14 [10-18] in the fusion group versus 11 [6-18]; p=0.049. CONCLUSION: Fusion imaging guidance does not affect radiation exposure and contrast volume during endovascular revascularisation of iliac and femoropopliteal occlusive disease in a hybrid room environment.

Diagnostic utility of fusion 18F-fluorodeoxyglucose positron emission tomography/cardiac magnetic resonance imaging in cardiac sarcoidosis.

BACKGROUND: Although each 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) and cardiac magnetic resonance (CMR) imaging with late gadolinium enhancement (LGE) has been used to diagnose cardiac sarcoidosis (CS), active CS is still misdiagnosed. METHODS: Active CS, diagnosed by PET alone, was defined as focal or focal on diffuse FDG uptake pattern. In fusion PET/CMR imaging, using a regional analysis with AHA 17-segment model, the patients were categorized into four groups: (1) PET-/LGE-, (2) PET+/LGE-, (3) PET+/LGE+, and (4) PET-/LGE+. PET+/LGE+ was defined as active CS. RESULTS: 74 Patients with suspected CS were enrolled. Between PET alone and fusion PET/CMR imaging, 20 cases had mismatch evaluations of active CS, and most had diffuse or focal on diffuse FDG uptake pattern on PET alone imaging. 40 Patients fulfilled the 2016 the Japanese Circulation Society diagnostic criteria for CS. The interobserver diagnostic agreement was excellent (κ statistics 0.89) and the overall accuracy for diagnosing CS was 87.8% in fusion PET/CMR imaging, which were superior to those in PET alone imaging (0.57 and 82.4%, respectively). In a sub-analysis of diffuse and focal on diffuse patterns, the agreement (κ statistics 0.86) and overall accuracy (81.8%) in fusion PET/CMR imaging were still better. CONCLUSIONS: Fusion PET/CMR imaging with regional analysis offered reliable and accurate diagnosis of CS, covering low diagnostic area by FDG-PET alone.

The usefulness of three-dimensional ultrasound fusion imaging for precise needle placement in liver thermal ablation: a phantom and an in vivo simulation study.

PURPOSE: To investigate the value of three-dimensional ultrasound fusion imaging (3DUS-FI) in real-time guiding needle placement by phantom models and in vivo simulations. MATERIALS AND METHODS: Two radiologists (beginner and expert) performed needle placement using two-dimensional ultrasound (2DUS) and 3DUS-FI, respectively. In the phantom study, single-needle placement was performed by puncturing the center point of each ball and assessed based on the specimen length. Multiple-needles placement was performed by placing three needles in each ball, and their locations were confirmed by computed tomography, and assessed based on the distance deviation between needles. In the in vivo simulation study, simulated-needle placement was performed by placing a virtual ablation needle in each liver tumor and assessed by the simulated ablative cover rate and margin. RESULTS: Specimen length was significantly longer with 3DUS-FI in the beginner, whereas no significant difference was observed in the expert (2DUS vs. 3DUS-FI: beginner, 14.60 ± 2.60 mm vs. 16.25 ± 1.38 mm, p = .017; expert, 16.78 ± 1.40 mm vs. 16.95 ± 1.15 mm, p = .668). Distance deviation between needles was significantly smaller with 3DUS-FI (2DUS vs. 3DUS-FI: beginner, 25.06 ± 16.07 mm vs. 3.72 ± 1.99 mm, p < .001; expert, 11.70 ± 7.79 mm vs. 2.89 ± 1.52 mm, p < .001). The simulated ablative cover rate and margin were significantly larger with 3DUS-FI for the beginner, whereas only the latter was significantly larger for the expert (2DUS vs. 3DUS-FI: beginner, 73.55 ± 8.73% vs. 81.38 ± 11.84%, p = .001, 0.82 ± 0.97 mm vs. 2.65 ± 1.23 mm, p < .001; expert, 78.60 ± 9.91% vs. 83.24 ± 11.69%, p = .059; 1.65 ± 1.15 mm vs. 2.95 ± 1.13 mm, p < .001). CONCLUSIONS: 3DUS-FI is useful for real-time guiding precise needle placement and may be further use to improve the efficacy of liver thermal ablation.

US-CT fusion-guided percutaneous radiofrequency ablation of large substernal benign thyroid nodules.

The aim of the present study was to assess feasibility, safety and outcome of ultrasound (US) guided percutaneous radiofrequency (RF) ablation of large substernal benign thyroid nodules assisted by US-computed tomography (CT) fusion imaging and real-time virtual needle tracking (VT) system. Thirty patients (18 females, mean age 56 y, range 32-76 y) with 35 benign nonfunctioning thyroid nodules (mean volume ± SD 26.8 ± 7.6 mL; range 20-38mL) were selected for CT-US fusion guided RF ablation. Nodules' volume was evaluated before treatment and during 12-months follow-up. Complications' rate was also evaluated. US-CT fusion imaging with VT system was feasible in all cases (feasibility 100%) and it was always possible to complete the procedure as planned (technical success 100%). Minor complications occurred in 2/30 cases (6.6%). No major complications occurred. 50% volume reduction (technique efficacy) was achieved in 93% cases, with a significant mean volume reduction at 12 months follow-up (68.7 ± 10.8%), (p < .001). The VT system could be useful in thyroid nodules ablation procedures assistance being able to track the RF electrode tip even when this is obscured by the bubbles produced by the ablative process. The combination of fusion imaging with VT assisted RF ablation represents a safe, non-surgical treatment option for patients with large substernal benign thyroid nodules.

Real-Time Evaluation of Blood Flow Patterns Using AneurysmFlow for an in vivo Abdominal Aortic Aneurysm Model.

BACKGROUND: Many new tools for abdominal aortic aneurysm (AAA) rupture risk evaluation have been developed. These new tools need detailed hemodynamic information in AAA. However, hemodynamic data obtained from in vivo research are lacking. Thus, the objective of this study was to analyze blood flow patterns in an in vivo AAA model to acquire real-time hemodynamic information using AneurysmFlow, a novel flow evaluation system. METHODS: Digital subtraction angiography images of patients who underwent endovascular aneurysm repair were analyzed using the visualization function of the AneurysmFlow to classify blood flow patterns as laminar or turbulent flow. The presence of boundary layer separation was also evaluated. The time taken for contrast medium to travel from the infrarenal aortic neck to aortic bifurcation was acquired to calculate the flow velocity. Associations between characteristics of aneurysm including lumen occupying ratio of intraluminal thrombus (ILT) and the hemodynamic flow pattern were evaluated. RESULTS: A total of 37 AAA patients was enrolled. Their blood flow patterns were evaluated using the AneurysmFlow. Logistic regression analyses with lumen occupying ratio of ILT as an independent variable showed that the larger the lumen occupying ratio of ILT, the more likely the aneurysm was to show a laminar pattern (P = 0.03), and the more likely the boundary layer separation would not exist (P = 0.04). The flow velocity from the infrarenal aortic neck to the aortic bifurcation showed a positive association with the lumen occupying ratio of the ILT in linear regression analysis (P < 0.001). CONCLUSIONS: Hemodynamic analysis of AAA with the AneurysmFlow using real-time individual patient models showed different flow patterns and flow velocities depending on ILT. This novel analytic approach using AneurysmFlow has potential to play an important role in obtaining clinically meaningful hemodynamic information of AAA.

Fusion imaging guided implantation of a Tricento transcatheter heart valve for severe tricuspid regurgitation.

We report the case of a 64-year-old patient with history of chronic kidney disease on dialysis who was repeatedly hospitalized due to hydropic decompensation. Right heart failure with secondary severe tricuspid regurgitation was diagnosed. An interventional approach was recommended due to the heavy calcification of the sinus venosus and the perioperative risk (EuroScore II 3.2%) and taking into account the explicit request of the patient. After analysis of a full-cycle computed tomography, the patient was eligible for the implantation of the Tricento transcatheter heart valve. The custom-made prosthesis was implanted successfully using periprocedural transoesophageal guidance supported by fusion imaging that integrates live co-registration. After implantation of the valve prosthesis, the primary result was excellent. The patient was discharged without further complications shortly after the procedure and her status is being closely monitored.