Publications by authors named "Vincent Vidal"

64 Publications

Pediatric brain arteriovenous malformation recurrence: a cohort study, systematic review and meta-analysis.

J Neurointerv Surg 2021 Sep 28. Epub 2021 Sep 28.

Department of Pediatric Radiology UMR 1163, Institut Imagine, INSERM U1000, APHP, Necker Sick Children Hospital, Paris, Paris, France.

Background: Recurrence following obliteration of brain arteriovenous malformations (AVMs) is common in children surgically treated, but recurrences following endovascular (EVT) and radiosurgical approaches are scantily reported.

Objective: To analyze the rates and risk factors for AVM recurrence after obliteration in a single-center cohort of children with ruptured AVMs treated with multimodal approaches, and to carry out a comprehensive review and meta-analysis of current data.

Methods: Children with ruptured AVMs between 2000 and 2019 enrolled in a prospective registry were retrospectively screened and included after angiographically determined obliteration to differentiate children with/without recurrence. A complementary systematic review and meta-analysis of studies investigating AVM recurrence in children between 2000 and 2020 was aggregated to explore the overall recurrence rates across treatment modalities by analyzing surgery versus other treatments.

Results: Seventy children with obliterated AVMs were included. AVM recurrences (n=10) were more commonly treated with EVT as final treatment (60% in the recurrence vs 13.3% in the no-recurrence group, p=0.018). Infratentorial locations were associated with earlier and more frequent recurrences (adjusted relative risk=4.62, 95% CI 1.08 to 19.04; p=0.04).In the aggregate analysis, the pooled rate of AVM recurrence was 10.9% (95% CI 8.7% to 13.5%). Younger age at presentation was associated with more frequent recurrences (RR per year increase, 0.97, 95% CI 0.93 to 0.99; p=0.046).

Conclusion: Location of infratentorial AVMs and younger age at presentation may be associated with earlier and more frequent recurrences. The higher rates of recurrence in patients with AVMs obliterated with EVT questions its role in an intent-to-cure approach and reinforces its position as an adjunct to surgery and/or radiosurgery.
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http://dx.doi.org/10.1136/neurintsurg-2021-017777DOI Listing
September 2021

Arterial Spin Labeling for the Etiological Workup of Intracerebral Hemorrhage in Children.

Stroke 2021 Sep 14:STROKEAHA120032690. Epub 2021 Sep 14.

Department of Pediatric Radiology UMR 1163, Institut Imagine, INSERM U1000, AP-HP, University hospital Necker-Enfants-malades, Paris, France. (J.F.H., G.B., B.K., F.G., L.G., N.B., V.D.R., F.B., O.N.).

Background And Purpose: Pediatric nontraumatic intracerebral hemorrhage accounts for half of stroke in children. Early diagnostic of the causative underlying lesion is the first step toward prevention of hemorrhagic recurrence. We aimed to investigate the performance of arterial spin labeling sequence (ASL) in the acute phase etiological workup for the detection of an arteriovenous shunt (AVS: including malformation and fistula), the most frequent cause of pediatric nontraumatic intracerebral hemorrhage.

Methods: Children with a pediatric nontraumatic intracerebral hemorrhage between 2011 and 2019 enrolled in a prospective registry were retrospectively included if they had undergone ASL-magnetic resonance imaging before any etiological treatment. ASL sequences were reviewed using cerebral blood flow maps by 2 raters for the presence of an AVS. The diagnostic performance of ASL was compared with admission computed tomography angiography, other magnetic resonance imaging sequences including contrast-enhanced sequences and subsequent digital subtraction angiography.

Results: A total of 121 patients with pediatric nontraumatic intracerebral hemorrhage were included (median age, 9.9 [interquartile range, 5.8-13]; male sex 48.8%) of whom 76 (63%) had a final diagnosis of AVS. Using digital subtraction angiography as an intermediate reference, visual ASL inspection had a sensitivity and a specificity of, respectively, 95.9% (95% CI, 88.5%-99.1%) and 79.0% (95% CI, 54.4%-94.0%). ASL had a sensitivity, specificity, and accuracy of 90.2%, 97.2%, and 92.5%, respectively for the detection of the presence of an AVS, with near perfect inter-rater agreement (κ=0.963 [95% CI, 0.912-1.0]). The performance of ASL alone was higher than that of other magnetic resonance imaging sequences, individually or combined, and higher than that of computed tomography angiography.

Conclusions: ASL has strong diagnostic performance for the detection of AVS in the initial workup of intracerebral hemorrhage in children. If our findings are confirmed in other settings, ASL may be a helpful diagnostic imaging modality for patients with pediatric nontraumatic intracerebral hemorrhage.

Registration: URL: https://www.clinicaltrials.gov; Unique identifiers: 3618210420, 2217698.
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http://dx.doi.org/10.1161/STROKEAHA.120.032690DOI Listing
September 2021

Hemorrhoid embolization: A review of current evidences.

Diagn Interv Imaging 2021 Aug 26. Epub 2021 Aug 26.

Vascular and Interventional Radiology, Department of Radiology, University of Minnesota, 55455 Minneapolis, USA.

Hemorrhoids are local vascular structure dilations in the lower rectum, associated with morbidity and reduced quality of life. Endovascular coil or particle embolization of the superior rectal arteries, known as Emborrhoid technique, is a minimally invasive, image-guided therapy that targets the hemorrhoidal plexus and reduces hemorrhage. The purpose of this review was to analyze the results of published studies to determine the efficacy, clinical outcomes, and morbidities associated with the endovascular occlusion of hemorrhoidal arteries for the treatment of internal hemorrhoids. Current evidences suggest that hemorrhoids treated by Emborrhoid technique using microcoils, embolic particles or a combination is safe with no reported serious complications. Hemorrhoid embolization can preserve the anal tone without direct anorectal trauma and maintain the hemorrhoidal tissue in place requiring minimal local wound care on an outpatient basis. However, due to the paucity of high-quality trials, further research is warranted to evaluate its long-term outcomes, compare its efficacy with other treatment modalities, and fully assess its role in the treatment of hemorrhoid.
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http://dx.doi.org/10.1016/j.diii.2021.07.001DOI Listing
August 2021

Advanced image guidance for prostatic artery embolization - a multicenter technical note.

CVIR Endovasc 2021 Aug 10;4(1):63. Epub 2021 Aug 10.

Endovascular Consultants of Colorado Lone Tree, Lone Tree, Colorado, USA.

Background: Prostatic artery embolization (PAE) is associated with patients' quality of life improvements and limited side effects compared to surgery. However, this procedure remains technically challenging due to complex vasculature, anatomical variations and small arteries, inducing long procedure times and high radiation exposure levels both to patients and medical staff. Moreover, the risk of non-target embolization can lead to relevant complications. In this context, advanced imaging can constitute a solid ally to address these challenges and deliver good clinical outcomes at acceptable radiation levels.

Main Text: This technical note aims to share the consolidated experience of four institutions detailing their optimized workflow using advanced image guidance, discussing variants, and sharing their best practices to reach a consensus standardized imaging workflow for PAE procedure, as well as pre and post-operative imaging.

Conclusions: This technical note puts forth a consensus optimized imaging workflow and best practices, with the hope of helping drive adoption of the procedure, deliver good clinical outcomes, and minimize radiation dose levels and contrast media injections while making PAE procedures shorter and safer.
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http://dx.doi.org/10.1186/s42155-021-00249-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8355292PMC
August 2021

Percutaneous lung and liver CT-guided ablation on swine model using microwave ablation to determine ablation size for clinical practice.

Int J Hyperthermia 2021 ;38(1):1140-1148

Department of Interventional Imaging, Assistance Publique Hopitaux de Marseille, Marseille, France.

Purpose: Microwave ablation (MWA) provides an effective treatment of lung and liver tumors but suffers from a lack of reproducibility of ablation size among currently available technologies. evaluations are far removed from clinical practices because of uninfused tissue. This study is preclinical testing of a new MWA system on swine lungs and liver.

Materials And Methods: All ablations were performed under CT guidance and multiple algorithms were tested with a power of 50, 75, and 100 W for durations of 3, 5, 8, 10, and 15 min. A 3 D-evaluation of the ablation zone was carried out using enhanced-CT. The sphericity index, coefficients of variation, and energy efficiency (which corresponds to the volume yield according to the power supplied) were calculated.

Results: Fifty liver and 48 lung ablations were performed in 17 swine. The sphericity index varies from 0.50 to 0.80 for liver ablations and from 0.40 to 0.69 for lung ablations. The coefficient of variation was below 15% for 4/5 and 4/8 protocols for lung and liver ablations, respectively. The energy efficiency seems to decrease with the duration of the ablation from 0.60 × 10 cm/J (75 W, 3 min) to 0.26 × 10 cm/J (100 W, 15 min) in the liver and from 0.57 × 10 cm/J (50 W, 10 min) to 0.42 × 10 cm/J (100 W, 12 min) in the lungs.

Conclusion: A shorter treatment time provides the best energy efficiency, and the best reproducibility is obtained for a 10 min treatment duration. The system tested provides an interesting reproducibility in both lung and liver measurements. Our results may help interventional radiologists in the optimal selection of treatment parameters.
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http://dx.doi.org/10.1080/02656736.2021.1961883DOI Listing
August 2021

Safety and Efficacy of Peripheral Embolization with EASYX Liquid Embolic Agent: A Multicenter Prospective Study.

J Vasc Interv Radiol 2021 Aug 5;32(8):1136-1143. Epub 2021 Jun 5.

Department of Vascular and Interventional Radiology, Image-Guided Therapy Center, ImViA Laboratory-EA 7535, François-Mitterrand University Hospital, Dijon, France.

Purpose: To evaluate the clinical safety and efficacy of EASYX, a new nonadhesive precipitating liquid embolic agent based on a polyvinyl alcohol ether polymer labeled with iodine molecules, for peripheral embolization.

Materials And Methods: This open-label prospective multicenter study was conducted on 50 consecutive patients treated with embolization using EASYX in 3 academic hospitals from April 2018 to July 2019. Indications for embolization were symptomatic varicocele (n = 15), type II endoleak (n = 8), acute hemorrhage (n = 16), portal vein embolization (PVE; n = 9), or angiomyolipoma (AML; n = 2). Patient characteristics, technical and clinical success rates, pain at injection, and satisfaction of the interventional radiologists were assessed. Follow-up imaging was performed using ultrasound for varicoceles (at 1 month) and computed tomography (CT) for the other indications (at 3 or 6 months).

Results: The immediate technical success rate was 98%. The clinical success rates were 100% for acute hemorrhage and type II endoleaks, 89% for PVE, 86% for varicoceles, and 50% for AMLs. Patients who underwent PVE showed significant hypertrophy of the future liver remnant at follow-up (P < .001), and 55.6% of patients proceeded to hepatectomy. The absence of artifacts on imaging allowed improved monitoring of the aneurysmal sac in patients with type II endoleaks. The satisfaction rate of the interventional radiologists was >90% for 5 of 7 items.

Conclusions: EASYX as a novel copolymer liquid embolic agent was safe and efficient for peripheral embolization. The absence of tantalum allowed reduced CT artifacts on imaging follow-up, which was especially useful in patients with type II endoleaks.
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http://dx.doi.org/10.1016/j.jvir.2021.05.014DOI Listing
August 2021

Description of morphological evolution of lung tumors treated by percutaneous radiofrequency ablation: long term follow-up of 100 lesions with chest CT.

Int J Hyperthermia 2021 ;38(1):786-794

Department of Medical Imaging, La Timone Hôpital, Marseille, France.

Purpose: Radiofrequency ablation (RFA) is a safe and effective minimally invasive treatment for pulmonary tumors. Patterns on chest computed tomography (CT) after RFA are classified into five types; however, the follow-up has not been fully described. The objectives of this study were to describe (1) the CT pattern 3 years after RFA and (2) its evolution over 7 years.

Materials And Methods: Lesions treated with RFA between 2009 and 2017 and with ≥3 years of follow-up CT data were included. Lesions with local recurrences were excluded from the study. The morphology of the ablation zone was classified as nodular, fibrotic, atelectatic, cavitary, and disappeared. Other initial anatomical parameters were recorded. Kruskal-Wallis or Chi-square tests were used to compare the groups.

Results: One hundred lung RFA scars were included, and a retrospective longitudinal study was performed. Three years after RFA, nodular, fibrotic, atelectatic, and cavitary scars, and disappearance were observed in 49%, 36%, 5%, 3%, and 6% of the scars, respectively. Evolution over 7 years showed that the fibrosis, atelectasis, and disappearance remained stable over time, whereas 28% of nodular scars evolved into fibrotic scars. Additionally, 45% of cavitary scars evolved into nodular scars. Pleural contact was associated with disappearance, and the use of a 20-mm needle was associated with atelectasis.

Conclusion: Follow-up after RFA showed that fibrosis, disappearance, and atelectasis remained stable over time. Nodular scars could evolve into fibrotic scars, and cavitary scars could evolve into nodular scars.
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http://dx.doi.org/10.1080/02656736.2021.1928773DOI Listing
July 2021

Catheter-Directed Hemorrhoidal Dearterialization Technique for the Management of Hemorrhoids: A Meta-Analysis of the Clinical Evidence.

J Vasc Interv Radiol 2021 Aug 7;32(8):1119-1127. Epub 2021 May 7.

Vascular and Oncologic Interventional Radiology Department, Hôpital Européen Georges Pompidou, Paris, France.

Purpose: To assess the efficacy and safety of a catheter-directed hemorrhoidal dearterialization technique for the management of hemorrhoidal bleeding.

Materials And Methods: A systematic review and meta-analysis of pubmed, cochrane, and scopus databases was conducted according to the preferred reporting items for systematic reviews and meta-Analysis (PRISMA) guidelines. Clinical studies reporting on catheter-directed hemorrhoidal dearterialization for rectal bleeding were analyzed.

Results: Fourteen studies (n = 362) were identified. The mean maximum follow-up duration was 12.1 months (SD, 7.31; range, 1-28; median, 12), and the mean length of hospital stay was 1.5 days (SD, 1.1; range, 0-2.5). The mean technical success was 97.8% (SD, 3.5), and the mean clinical success was 78.9% (SD, 10.5). A statistically significant reduction in the french bleeding score before and after embolization was noted (P = .004). In subgroup analysis, when the coils-only group was compared with the coils and particles group, the average rebleeding rate was 21.5% (n = 111; SD, 18.2; range, 0%-44%) versus 10.05% (N = 108; SD, 4.8; range, 5%-15.7%), respectively (P < .0001). No bowel ischemia/necrosis or anorectal complications were reported.

Conclusions: The current preliminary clinical evidence suggests that catheter-directed hemorrhoidal dearterialization is an effective and safe procedure for the treatment of hemorrhoidal bleeding. The standardization of the technique and the generation of higher level evidence will be required to compare this minimally invasive procedure with more invasive surgical options for patients with grades I-III hemorrhoids and chronic bleeding.
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http://dx.doi.org/10.1016/j.jvir.2021.03.548DOI Listing
August 2021

Efficacy and safety of regorafenib in patients with metastatic or locally advanced chondrosarcoma: Results of a non-comparative, randomised, double-blind, placebo controlled, multicentre phase II study.

Eur J Cancer 2021 06 22;150:108-118. Epub 2021 Apr 22.

Medical Oncology Department, Centre Léon Bérard, Lyon, France.

Background: This multi-cohort trial explored the efficacy and safety of regorafenib for patients with advanced sarcomas of bone origin; this report details the cohort of patients with metastatic or locally advanced chondrosarcoma (CS), progressing after prior chemotherapy.

Patients And Methods: Patients with CS, progressing despite prior standard therapy, were randomised (2:1) to receive regorafenib or placebo. Patients on placebo could crossover to receive regorafenib after centrally confirmed progressive disease. The primary endpoint was progression-free rate (PFR) at 12 weeks. With one-sided α of 0.05, and 80% power, at least 16/24 progression-free patients at 12 weeks were needed for success (P0 = 50%, P1 = 75%).

Results: From September 2014 to February 2019, 46 patients were included in the CS cohort, and 40 patients were evaluable for efficacy: 16 on placebo and 24 on regorafenib. Thirteen patients (54.2%; 95% CI [35.8%-[) were non-progressive at 12 weeks on regorafenib versus 5 (31.3%; 95% CI [13.2%-[);) on placebo. Median PFS was 19.9 weeks on regorafenib, and 8.0 on placebo. Fourteen placebo patients crossed over to regorafenib after progression. The most common grade ≥3 treatment-related adverse events on regorafenib included hypertension (12%), asthenia (8%), thrombocytopenia (8%) and diarrhoea (8%). One episode of fatal liver dysfunction occurred on regorafenib.

Conclusion: Although the primary endpoint was not met statistically in this small randomised cohort, there is modest evidence to suggest that regorafenib might slow disease progression in patients with metastatic CS after the failure of prior chemotherapy.

Clinical Trial Registration: The trial is registered at ClinicalTrials.gov (NCT02389244).
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http://dx.doi.org/10.1016/j.ejca.2021.03.039DOI Listing
June 2021

Progression of adenomyosis magnetic resonance imaging features under ulipristal acetate for symptomatic fibroids.

Reprod Biomed Online 2021 Mar 26;42(3):661-668. Epub 2020 Nov 26.

Department of Obstetrics and Gynecology, Assistance Publique Hôpitaux de Marseille, La Conception Hospital, Aix Marseille University, Marseille 13005, France.

Research Question: What is the evolution of adenomyosis on magnetic resonance imaging (MRI) after a 3-month treatment course of daily 5 mg doses of ulipristal acetate (UPA) for symptomatic fibroids?

Design: A monocentric prospective pilot study on patients who underwent a 3-month treatment course of UPA for symptomatic fibroids between January 2014 and December 2017. Patients underwent pelvic MRI shortly before (pre-MRI) and after treatment (post-MRI). The diagnosis of adenomyosis on MRI was defined by the observation of intramyometrial cysts and/or haemorrhagic foci within these cystic cavities and/or a thickening of the junctional zone >12 mm. The progression of adenomyosis was defined by the presence of at least one of the aforementioned criteria of adenomyosis on the pre-MRI and by at least one of the following on the post-MRI: (i) increased thickness of the junctional zone ≥20% and/or (ii) increased number of intramyometrial cysts. The appearance of adenomyosis was defined by the absence of the aforementioned criteria of adenomyosis on the pre-MRI and the presence of at least one of these criteria on the post-MRI.

Results: Seventy-two patients were included. The MRI features of adenomyosis progressed for 12 of 15 patients (80.0%) for whom adenomyosis was identified on the pre-MRI. An appearance of adenomyosis was identified after treatment for 15 of 57 patients (26.3%) for whom adenomyosis was not identified on the pre-MRI.

Conclusions: A 3-month treatment course of daily 5 mg doses of UPA could provoke a short-term progression or an emergence of typical adenomyosis intramyometrial cysts on MRI examinations.
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http://dx.doi.org/10.1016/j.rbmo.2020.11.012DOI Listing
March 2021

Combination of Alcohol and EVOH as a New Embolic Agent: Midterm Tissue and Inflammatory Effects in a Swine Model.

Radiol Res Pract 2020 23;2020:8831060. Epub 2020 Oct 23.

Diagnostic and Interventional Radiology Section, Department of Medical Imaging, University Hospital Timone APHM, 278 Rue Saint-Pierre, Marseille 13005, France.

Objective: To evaluate the vascular occlusion and midterm tissue toxicity properties of a combination of ethylene-vinyl alcohol (EVOH) (Squid 18®) (75%) and alcohol (25%)-Alco-Squid 18-in a swine model.

Materials And Methods: Alco-Squid 18 (75% Squid 18® mixed with 25% alcohol) (AS18) was compared to embolization with 96% alcohol alone and to embolization with Squid 18® (S18®) alone. An arteriovenous malformation (AVM) model was created in group 1 ( = 2). Each AVM model was then embolized with AS18 or S18® alone with evaluation of a ratio between the volume of embolic agent divided by the volume of the AVM (evaluated by CT). For group 2 ( = 5), each agent was tested on three different kidneys (upper pole kidney artery). Pre- and postinterventional CTs, angiographies, blood alcohol content dosages, and histological studies (3 months postintervention) were performed.

Results: AS18 has better distal distribution than S18® alone, both in the kidneys (mean capsule-S18® distance: 3.9 mm (±0.23) and mean capsule-AS18 distance: 2.3 mm (±0.11) (=0.029) and in the AVM model. Histological exploration found a higher rate of tubular necrosis with AS18 compared with S18® alone and alcohol alone (3.78 ± 0.44 compared to 2.33 ± 1.22 ( = 0.012) and 1.22 ± 0.67 (  < 0 .0001)). The blood alcohol content was negligible in all cases.

Conclusion: AS18 can suggest a better distal sclerotic and embolic character as compared with S18® alone without systemic toxicity.
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http://dx.doi.org/10.1155/2020/8831060DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7605951PMC
October 2020

FairEmbo Concept for Arterial Embolizations: In Vivo Feasibility and Safety Study with Suture-Based Microparticles Compared with Microspheres.

Cardiovasc Intervent Radiol 2021 Apr 25;44(4):625-632. Epub 2020 Oct 25.

Interventional Radiololy Section, Department of Medical Imaging, University Hospital Timone, APHM, Marseille, France.

Purpose: Microspheres are effective embolic agents, especially for the management of bleeding and oncologic lesions. The first FairEmbo study reported the effectiveness of embolization using suture fragments. The effectiveness and safety of arterial embolization with suture-based microparticles (SBM) were assessed in a swine model.

Materials And Methods: In this ethical-approved animal study, a polar artery in each kidney was embolized in four swine: one side with hand-cut non-absorbable SBM (Flexocrin 2®) and the contralateral side with Embozene® 900 for comparison. Swine were followed for 3 months (M3) to evaluate the effectiveness and the safety of SBM. Follow-up protocol included clinical monitoring, computed tomography (CT) control and digital subtraction angiography (DSA), followed by histological analyses. The SBM confection parameters were evaluated by automatic microscopic sizer. RStudio software and Mann-Whitney test (significance at P < 0.05) were used for statistics.

Results: The average size of SBM was 1002 μm (SD = 258). All targets were effectively embolized by SBM with an angiogram defect estimated at 45.6% (95% CI [35.9-55.2]), compared to 40.5% (95% CI [30.6-55.5]) for Embozene® group (P = 0.342). The average duration of SBM embolization procedure was significantly increased compared to Embozene® embolization (1202 s versus 222 s, P = 0.029). There were no statistical differences in M3 DSA and CT for SBM and Embozene®, with persistence of partial arterial occlusion and atrophic embolized area. No postoperative complications were observed on clinical and CT controls.

Conclusion: This experimental study suggests that embolization with SBM is feasible, safe and effective in short- and medium-term follow-up as compared to microspheres.
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http://dx.doi.org/10.1007/s00270-020-02678-0DOI Listing
April 2021

Efficacy and Safety of Surgery for Benign Prostatic Obstruction in Patients with Preoperative Urinary Catheter.

J Endourol 2021 01 23;35(1):102-108. Epub 2020 Sep 23.

Department of Urology and Kidney Transplantation, Conception Academic Hospital, Aix-Marseille University, APHM, Marseille, France.

To evaluate the efficacy and safety of benign prostatic obstruction (BPO) surgery in patients with preoperative urinary catheterization. We conducted a multi-institutional retrospective study including all patients who failed a trial without catheter (TWOC) after acute urinary retention (AUR) between January 2017 and January 2019. Patients with neurogenic bladder, prostate cancer, or urethral stricture were excluded from the analysis. Patients underwent either monopolar/bipolar transurethral resection of the prostate (TURP), photoselective vaporization of the prostate (PVP), prostate artery embolization (PAE), open prostatectomy (OP), or endoscopic enucleation. The primary endpoint was 12-month urinary catheter-free survival without using benign prostatic hyperplasia medications. One hundred seventy-one consecutive men (median age: 71 years; median prostate volume: 75 cm) underwent BPO surgery, including 48 (28%) TURP, 62 (36.3%) PVP, 21 (12.3%) endoscopic enucleation, 15 (8.8%) PAE, and 25 (14.6%) OP. The median duration of preoperative urinary catheterization was 69 days (interquartile range 46-125). The 12-month urinary catheter-free survival rate was 84.8% (145/171). Satisfactory voiding returned to 121 patients (70.8%). On backward stepwise multivariable analysis, PVP (odds ratio [OR] 0.27 [0.10-0.69];  = 0.008), PAE (OR 5.27 [1.28-27.75];  = 0.03), endoscopic enucleation (OR 0.08 [0-0.49];  = 0.023), OP (OR 0.10 [0.01-0.57];  = 0.034), Charlson score (OR 1.36 [1.14-1.66];  = 0.001), and number of preoperative TWOC failure (OR 2.53 [1.23-5.51];  = 0.014) were significantly associated with catheter-free survival. In this multi-institutional retrospective study, including patients with preoperative catheterization, the overall success rate of BPO surgery was 70.8% after 1-year follow-up. Compared with TURP, enucleation methods and PVP were associated with better catheter-free survival, whereas PAE was associated with higher risk of AUR recurrence.
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http://dx.doi.org/10.1089/end.2020.0704DOI Listing
January 2021

The role of interventional radiology in the management of abnormally invasive placenta: a systematic review of current evidences.

Quant Imaging Med Surg 2020 Jun;10(6):1370-1391

Department of Radiology, Hopital Cochin, Assistance Publique - Hopitaux de Paris, Paris, France.

Abnormally invasive placenta (AIP) is a potentially severe condition. To date, arterial embolization in women with postpartum hemorrhage due to AIP is the treatment option for which highest degrees of evidence are available. However, other techniques have been tested, including prophylactic catheter placement, balloon occlusion of the iliac arteries and abdominal aorta balloon occlusion. In this systematic review, we provide an overview of the currently reported interventional radiology procedures that are used for the treatment of postpartum hemorrhage due to AIP and suggest recommendations based on current evidences. Owing to a high rate of adverse events, prophylactic occlusion of internal iliac arteries should be used with caution and applied when the endpoint is hysterectomy. On the opposite, when a conservative management is considered to preserve future fertility, uterine artery embolization should be the preferred option as it is associated with a hysterectomy rate of 15.5% compared to 76.5% with prophylactic balloon occlusion of the internal iliac arteries and does not result in fetal irradiation. Limited data are available regarding the application of systematic prophylactic embolization and no comparative studies with arterial embolization are available.
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http://dx.doi.org/10.21037/qims-20-548DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7276355PMC
June 2020

Selective Trans-arterial Embolization of Iatrogenic Vascular Lesions Did Not Influence the Global Renal Function After Partial Nephrectomy.

Urology 2020 Jul 10;141:108-113. Epub 2020 Apr 10.

Aix-Marseille University, APHM, Nord Academic Hospital, Dept. of Urology, Marseille, France.

Objective: To evaluate the renal function outcomes after selective trans-arterial embolization (SAE) of iatrogenic vascular lesions (IVL), including pseudoaneurysm and arteriovenous fistula, following partial nephrectomy (PN).

Materials And Methods: A multi-institutional study was conducted including consecutive patients who underwent PN between January 2009 and March 2019. Two surgical approaches were used: open and robot-assisted PN. Patients with SAE were identified and matched (1:2) with patients without IVL. The matching criteria were age, gender, Charlson score, creatinine clearance, RENAL score, and tumor size. The primary outcome was the evolution of global renal function at 6-months postoperatively.

Results: A total of 493 consecutive PN (360 open PN and 133 robot-assisted PN) were included. IVL occurred in 17 cases (3.4%) without statistical difference according to the surgical approach (P = .78). Patients from embolization group were matched to 34 cases without postoperative IVL. Groups were comparable concerning clinical, tumor and surgical characteristics. The clinical success of SAE, defined as the absence of recourse to a second embolization or a total nephrectomy, was obtained in 16 (94.1%) cases. No minor or major complications were reported after SAE. The preoperative estimated glomerular filtration rate (eGFR) was similar between control group (93 [85-102] ml/min) and embolization group (95 [83-102] ml/min) (P = .99). Median (IQR) eGFR between control group (87 [72-95] ml/min) and embolization group (83 [76-93] ml/min) at a follow-up of 6 months showed no significant difference (P = .73).

Conclusion: IVL are rare complications of PN. SAE is an effective and minimally invasive management tool, with no deleterious effect on global renal function.
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http://dx.doi.org/10.1016/j.urology.2020.03.036DOI Listing
July 2020

Early mortality attributable to PICC-lines in 4 public hospitals of Marseille from 2010 to 2016 (Revised V3).

Medicine (Baltimore) 2020 Jan;99(1):e18494

AP-HM.

Introduction: Peripherally inserted central catheters (PICC-line) are devices inserted through peripheral venous access. In our institution, this technology has been rapidly adopted by physicians in their routine practice. Bacteremia on catheters remains an important public health issue in France. However, the mortality attributable to bacteremia on PICC-line remains poorly evaluated in France and in the literature in general. We report in our study an exhaustive inventory of bacteremia on PICC-line and their 30 days mortality, over a 7 years period.

Material And Methods: From January 2010 to December 2016, we retrospectively matched PICC-line registers of the radiology department, blood culture records of the microbiology laboratory and medical records from the Hospital Information Systems.

Results: The 11,334 hospital stays during which a PICC-line was inserted were included over a period of 7 years. Among them, 258 episodes of PICC-line-associated bacteremia were recorded, resulting in a prevalence of 2.27%. Hematology units: 20/324 (6.17%), oncology units: 55/1375 (4%) and hepato-gastro-enterology units: 42/1142 (3.66%) had the highest prevalence of PICC-line related bacteremia. The correlation analysis, when adjusted by exposure and year, shows that the unit profile explains 72% of the variability in the rate of bacteremia with a P = .023. Early bacteremia, occurring within 21 days of insertion, represented 75% of cases. The crude death ratio at 30 days, among patients PICC-line associated bacteremia was 57/11 334 (0.50%). The overall 30-day mortality of patients with PICC-line with and without bacteremia was 1369/11334 (12.07%). On day 30, mortality of patients with bacteremia associated PICC-line was 57/258 or 22.09% of cases, compared to a mortality rate of 1311/11076, or 11.83% in the control group (P < .05, RR 2.066 [1.54-2.75]). Kaplan-Meier survival analysis revealed a statistically significant excess mortality between patients with PICC-line associated bacteremia and PICC-line carriers without bacteremia (P < .0007, hazard ratio 1.89 [1307-2709]).

Conclusion: Patients with PICC-line associated bacteremia have a significant excess mortality. The implementation of a PICC-line should remain the last resort after a careful assessment of the benefit/risk ratio by a senior doctor.
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http://dx.doi.org/10.1097/MD.0000000000018494DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6946566PMC
January 2020

[Central venous access in interventional radiology].

Presse Med 2019 Oct 25;48(10):1141-1145. Epub 2019 Oct 25.

AP-HM, hôpital La Timone, service de radiologie interventionnelle, 265, rue Saint-Pierre, 13005 Marseille, France; Aix-Marseille université, LIIE, Marseille, France; Aix-Marseille université, CERIMED, Marseille, France.

Some patients require iteratives intravenous administrations on a central catheter, for example in oncology or infectiology, which represents a challenge for ambulatory treatment. Interventional radiology could provide solutions with the implant and monitoring of PICC-lines and ports. These are implanted in sterile environment and under imaging guidance in an interventional radiology room by an operator and with a paramedical team that need to be experienced. This development focus on the interest of one method with respect to the other, as well as the differents ways to do, the complications that could arise and the monitoring of these devices.
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http://dx.doi.org/10.1016/j.lpm.2019.10.013DOI Listing
October 2019

Predictors of uterine fibroid volume reduction under ulipristal acetate: a prospective MRI study.

Reprod Biomed Online 2019 Nov 17;39(5):795-801. Epub 2019 Jul 17.

Department of Obstetrics and Gynecology, Assistance Publique Hôpitaux de Marseille, La Conception Hospital, Aix Marseille University, France.

Research Question: Can patient and/or uterine fibroid characteristics predict the volume reduction of fibroids under ulipristal acetate (UPA) treatment?

Design: This was a monocentric observational prospective cohort study of women with symptomatic fibroids who were willing to undergo surgery after a 3-month treatment of daily 5 mg doses of UPA. Patients underwent magnetic resonance imaging before and after treatment, and the volumes of the three largest fibroids were assessed. The reduction in volume was assessed qualitatively: fibroids decreasing in volume were considered to be 'responsive' to treatment, and fibroids that were stable or increased in volume were considered to be 'non-responsive'. Comparisons were made of patient (age and body mass index) and fibroid (initial volume, number and location) characteristics between fibroids that were responsive and non-responsive to UPA treatment.

Results: Fifty-three women were included in the final analysis and 116 fibroids were measured. The initial number and initial volume of the fibroids were statistically associated with the response to UPA treatment (adjusted odds ratio [OR] 0.645, 95% confidence interval [CI] 0.461-0.903, P = 0.0115 for number of fibroids, and adjusted OR 1.447, 95% CI 1.063-1.970, P = 0.0195 for initial volume, with a log-linear relationship). Submucosal fibroids had a higher response rate to treatment (i.e. a decrease in volume) than intramural fibroids (21/25 [84.0%] versus 15/28 [53.6%]; P = 0.0490; adjusted OR 4.478, 95% CI 1.007-19.918).

Conclusions: The location, initial volume and number of fibroids may allow prediction of the outcome of a single 3-month treatment course of daily 5 mg doses of UPA in terms of reduction in volume before surgery.
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http://dx.doi.org/10.1016/j.rbmo.2019.07.028DOI Listing
November 2019

A French survey of contraceptive implant migration to the pulmonary artery.

Contraception 2019 10 10;100(4):255-257. Epub 2019 Jun 10.

Department of Gynecology and Obstetrics, La Conception Hospital, Marseille, France. Electronic address:

Objective(s): To quantify implant migration to the pulmonary artery in France since 2012 and to describe the diagnoses and treatments.

Study Design: We surveyed 780 physicians of the French national implant-referral network, the French Society of Chest and Cardiovascular Surgery, and the French Radiology Society about diagnosis of implant migration to the pulmonary artery vasculature. We evaluated total implant insertions in France using data from the Medic'AM database.

Results: We identified 12 cases from 2012 to 2017. Ten of the cases were asymptomatic. Five devices were removed via interventional radiology, five surgically, and two were left in place. The number of insertions in France during the same years was approximately 1,200,000.

Conclusion(s): Pulmonary artery migration following contraceptive implant insertion is rare with a migration incidence of 1 in 100,000. Most cases were diagnosed incidentally.
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http://dx.doi.org/10.1016/j.contraception.2019.05.016DOI Listing
October 2019

[Emborrhoid: Rectal arteries embolization for hemorrhoid treatment].

Presse Med 2019 Apr 3;48(4):454-459. Epub 2019 May 3.

Assistance publique-hôpitaux de Marseille, hôpital de la Timone, service d'imagerie diagnostic et interventionnelle, 264, rue Sainte-Pierre, 13005 Marseille, France; Université Aix-Marseille, CERIMED, faculté de médecine, EA 4264, laboratoire d'imagerie interventionnelle expérimentale (LIIE), 27, boulevard Jean-Moulin, 13005 Marseille, France.

Although hemorrhoids are recognized as a very common cause of rectal bleeding and known for a long time, its treatment has evolved dramatically over the last twenty years. Among the new minimally invasive methods, the "Emborrhoid" technique consists into selective embolization of hemorrhoidal arteries, branches arising from the superior rectal arteries using microcoils. This technique is based on a demonstrated pathophysiological concept of arterial network hypertrophy in hemorrhoid disease. This technique was evaluated in an animal model and then in clinical research on more than 100 patients. No ischemic complications were identified. Studies describe an improvement of 60 to 80% of the symptoms, with on average 30% recurrences at two years. The recurrence rae is likely related to a technically incomplete embolization. Future prospects are focused on more selective embolization with Particulate embolic agents.
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http://dx.doi.org/10.1016/j.lpm.2019.04.011DOI Listing
April 2019

Efficacy and safety of regorafenib in adult patients with metastatic osteosarcoma: a non-comparative, randomised, double-blind, placebo-controlled, phase 2 study.

Lancet Oncol 2019 01 23;20(1):120-133. Epub 2018 Nov 23.

Medical Oncology Department, Centre Léon Bérard, Lyon, France.

Background: Regorafenib has proven activity in patients with pretreated gastrointestinal stromal tumours and colorectal and hepatocellular carcinoma. We designed REGOBONE to assess the efficacy and safety of regorafenib for patients with progressive metastatic osteosarcoma and other bone sarcomas. This trial comprised four parallel independent cohorts: osteosarcoma, Ewing sarcoma, chondrosarcoma, and chordoma. In this Article, we report the results of the osteosarcoma cohort.

Methods: In this non-comparative, double-blind, placebo-controlled, phase 2 trial, patients aged 10 years or older with histologically confirmed osteosarcoma whose disease had progressed after treatment with one to two previous lines of chemotherapy for metastatic disease and an Eastern Cooperative Oncology Group performance status of 0 or 1 were enrolled. Patients were randomly assigned (2:1) to receive either oral regorafenib (160 mg/day, for 21 of 28 days) or matching placebo. Patients in both groups also received best supportive care. Randomisation was done using a web-based system and was stratified (permuted block) by age at inclusion (<18 vs ≥18 years old). Investigators and patients were masked to treatment allocation. Patients in the placebo group, after centrally confirmed progressive disease, could cross over to receive regorafenib. The primary endpoint was the proportion of patients without disease progression at 8 weeks. Analyses were done by modified intention to treat (ie, patients without any major entry criteria violation who initiated masked study drug treatment were included). All participants who received at least one dose of study drug were included in the safety analyses. This study is registered with ClinicalTrials.gov, number NCT02389244, and the results presented here are the final analysis of the osteosarcoma cohort (others cohorts are ongoing).

Findings: Between Oct 10, 2014, and April 4, 2017, 43 adult patients were enrolled from 13 French comprehensive cancer centres. All patients received at least one dose of assigned treatment and were evaluable for safety; five patients were excluded for major protocol violations (two in the placebo group and three in the regorafenib group), leaving 38 patients who were evaluable for efficacy (12 in the placebo group and 26 in the regorafenib group). 17 of 26 patients (65%; one-sided 95% CI 47%) in the regorafenib group were non-progressive at 8 weeks compared with no patients in the placebo group. Ten patients in the placebo group crossed over to receive open-label regorafenib after centrally confirmed disease progression. 13 treatment-related serious adverse events occurred in seven (24%) of 29 patients in the regorafenib group versus none of 14 patients in the placebo group. The most common grade 3 or worse treatment-related adverse events during the double-blind period of treatment included hypertension (in seven [24%] of 29 patients in the regorafenib group vs none in the placebo group), hand-foot skin reaction (three [10%] vs none), fatigue (three [10%] vs one [3%]), hypophosphataemia (three [10%] vs none), and chest pain (three [10%] vs none). No treatment-related deaths occurred.

Interpretation: Regorafenib demonstrated clinically meaningful antitumour activity in adult patients with recurrent, progressive, metastatic osteosarcoma after failure of conventional chemotherapy, with a positive effect on delaying disease progression. Regorafenib should be further evaluated in the setting of advanced disease as well as potentially earlier in the disease course for patients at high risk of relapse. Regorafenib might have an important therapeutic role as an agent complementary to standard cytotoxic chemotherapy in the therapeutic armamentarium against osteosarcoma.

Funding: Bayer HealthCare.
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http://dx.doi.org/10.1016/S1470-2045(18)30742-3DOI Listing
January 2019

Short-term outcomes after major hepatic resection in patients with cirrhosis: a 75-case unicentric western experience.

HPB (Oxford) 2019 03 16;21(3):352-360. Epub 2018 Aug 16.

Department of Digestive Surgery, Hôpital de la Timone, Marseille, France; Université Aix-Marseille, 27 Boulevard Jean Moulin, 13385, Marseille, France.

Background: The benefit of performing major hepatic resection (MHR) for hepatocellular carcinoma (HCC) in patients with cirrhosis remains controversial because of its high risk of posthepatectomy liver failure (PHLF). This study was conducted to assess the risk of MHR for HCC in patients with cirrhosis.

Methods: Patients with Child-Pugh A or B cirrhosis and HCC who underwent MHR from January 2000 to June 2014 were retrospectively identified. Risk factors for postoperative morbidity and mortality using univariate and multivariate analyses were evaluated.

Results: Seventy patients with Child-Pugh A (93%) and 5 (7%) with Child-Pugh B cirrhosis underwent MHR for HCC. Thirteen (17%) had Barcelona Clinic Liver Cancer (BCLC) stage A, 39 (50%) had BCLC B, and 23 (32%) had BCLC C disease. A perioperative blood transfusion was performed in 18 patients (24%). Ninety-day postoperative mortality was 9% (n=7). Major complications occurred in 16 patients (21%), including PHLF in 9 patients (12%). A multivariate analysis showed that perioperative blood transfusion was the main independent factor associated with mortality (OR= 6.5) and major morbidity (OR=10).

Conclusion: In selected patients with HCC and cirrhosis, MHR is feasible and has acceptable mortality, but careful perioperative management and limiting blood loss are required.
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http://dx.doi.org/10.1016/j.hpb.2018.07.020DOI Listing
March 2019

Outcomes of Pulmonary Artery Embolization and Stent Graft Placement for the Treatment of Hemoptysis Caused by Lung Tumors.

J Vasc Interv Radiol 2018 07 5;29(7):975-980. Epub 2018 May 5.

Hôpital de la Timone, 264 Rue Saint Pierre, 13005 Marseille, France; Institut Paoli Calmettes, Marseille, France.

Purpose: To evaluate the safety and efficacy of endovascular management of pulmonary artery lesions caused by lung tumors.

Materials And Methods: Nineteen patients (15 men, 4 women; average age: 60.3 years, range, 51-86 years) treated for massive or recurrent hemoptysis with transarterial pulmonary artery embolization between 2010 and 2016 were included in this multicenter, retrospective study. Inclusion criteria were: patients with lung cancer and at least 1 episode of hemoptysis with a pulmonary artery lesion detected by computed tomography (CT) angiography or after failed bronchial artery embolization. No patient undergoing pulmonary embolization for a lung tumor was excluded. Technical success, clinical success, and complications were recorded. The survival curve was estimated using the Kaplan-Meier method RESULTS: Mean follow-up was 188.1 days (range, 0-1440 days). Primary and assisted technical success rates were 73.7% (14/19) and 84.2% (16/19), respectively. Two patients died during the procedure due to massive hemoptysis and cardiac arrest, and 1 patient was treated with surgery. All patients with technical success achieved clinical success without further bleeding. No complications were noted, and no pulmonary infarction was detected on CT scan during follow-up. Survival rates after embolization at 1 and 3 months were 67% (95% confidence interval [CI]: 40%-90%) and 46% (95% CI: 23%-80%), respectively, with 36.8% (n = 7) of the patients still alive at the end of the study.

Conclusions: Embolization is an effective and safe treatment of lung tumors with pulmonary arterial bleeding.
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http://dx.doi.org/10.1016/j.jvir.2018.01.773DOI Listing
July 2018

Embolization of the Superior Rectal Arteries for Hemorrhoidal Disease: Prospective Results in 25 Patients.

J Vasc Interv Radiol 2018 06 30;29(6):884-892.e1. Epub 2018 Apr 30.

Department of Interventional Radiology, Marseille Public University Hospital System, La Timone University Hospital, 264 Rue Saint Pierre, Marseille 13385, Cedex 05, France; Experimental Interventional Imaging Laboratory, Aix Marseille University, Marseille, France.

Purpose: To evaluate efficacy and safety of superior rectal artery embolization of hemorrhoidal disease as a first-line invasive treatment.

Materials And Methods: This prospective study was conducted between 2014 and 2015 on 25 consecutive patients (16 men and 9 women with a mean age of 53 y [range, 30-76 y]) with grade II-III hemorrhoids refractory to medical treatment. A transfemoral superselective superior rectal artery branch embolization was performed using 2- and 3-mm diameter microcoils. Over the following 12 months, clinical outcomes were evaluated using the French bleeding score, Goligher prolapse score, visual analog scale (VAS) score for pain, quality-of-life score. The primary endpoint was relief of symptoms by 12 months based on a 2-point minimum improvement on VAS score and bleeding score.

Results: At 12 months after embolization, clinical success was obtained in 18 patients (72%), 8 of whom had 2 embolizations. VAS score decreased from 4.6 to 2.3 (P < .01), and bleeding score decreased from 5.5 to 2.3 (P < .01). Quality-of-life and prolapse scores also showed improvement (P < .05), and no patients experienced any early or late complications. Complete clinical failure was observed in 7 patients. After coil embolization, the collateral supply to the hemorrhoidal cushions was significantly related to any recurrence (P = .001).

Conclusions: Hemorrhoidal artery coil embolization was found to be a safe and effective treatment for grade II-III hemorrhoids.
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http://dx.doi.org/10.1016/j.jvir.2018.01.778DOI Listing
June 2018

A rare case of a venous malformation of the clitoris.

Eur J Obstet Gynecol Reprod Biol 2018 05 16;224:202-203. Epub 2018 Mar 16.

Department of Medical Imaging, Assistance Publique Hôpitaux de Marseille, La Timone Hospital, 13005 Marseille, Aix Marseille University, France; Department of Obstetrics and Gynecology, Assistance Publique Hôpitaux de Marseille, La Conception Hospital, 13005 Marseille, Aix Marseille University, France; Department of Medical Imaging, Assistance Publique Hôpitaux de Marseille, La Timone Hospital, 13005 Marseille, Aix Marseille University, France; Department of Obstetrics and Gynecology, Assistance Publique Hôpitaux de Marseille, La Conception Hospital, 13005 Marseille, Aix Marseille University, France. Electronic address:

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http://dx.doi.org/10.1016/j.ejogrb.2018.03.018DOI Listing
May 2018

Portal vein stenosis preconditioning of living donor liver in swine: early mechanisms of liver regeneration and gain of hepatic functional mass.

Am J Physiol Gastrointest Liver Physiol 2018 07 22;315(1):G117-G125. Epub 2018 Feb 22.

Experimental Interventional Imaging Laboratory EA-4264, European Centre for Medical Imaging Research, Aix-Marseille University , Marseille , France.

To reduce the morbidity and mortality risk for the donor in living donor liver transplantation (LDLT), we previously identified 20% left portal vein (LPV) stenosis as an effective preconditioning method to induce cell proliferation in the contralateral lobe without downstream ipsilateral atrophy. In this study, we report the pathways involved in the first hours after preconditioning and investigate the changes in liver volume and function. Fourteen pigs were used this study. Five pigs were used to study the genetic, cellular and molecular mechanisms set up in the early hours following the establishment of our preconditioning. The remaining nine pigs were equally divided into three groups: sham-operated animals, 20% LPV stenosis, and 100% LPV stenosis. Volumetric scanning and 99 mTc-Mebrofenin hepatobiliary scintigraphy were performed before preconditioning and 14 days after to study morphological and functional changes in the liver. We demonstrated that liver regeneration triggered by 20% LPV stenosis in the contralateral lobe involves TNF-α, IL-6, and inducible nitric oxide synthase 2 by means of STAT3 and hepatocyte growth factor. We confirmed that our preconditioning was responsible for an increase in the total liver volume. Finally, we demonstrated that this volumetric gain was associated with an increase in hepatic functional capacity. NEW & NOTEWORTHY We describe a new preconditioning method for major hepatectomy that is applicable to hepatectomy for donation. We identified 20% left portal vein stenosis as effective preconditioning that is capable of inducing cell proliferation in the contralateral lobe without the downstream ipsilateral atrophy. In this study, we report the pathways involved in the first hours following preconditioning, and we confirm that 20% left portal vein stenosis is responsible for an increase in the functional capacity and total liver volume in a porcine model.
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http://dx.doi.org/10.1152/ajpgi.00390.2017DOI Listing
July 2018

Efficacy and safety of selective internal radiotherapy with yttrium-90 resin microspheres compared with sorafenib in locally advanced and inoperable hepatocellular carcinoma (SARAH): an open-label randomised controlled phase 3 trial.

Lancet Oncol 2017 12 26;18(12):1624-1636. Epub 2017 Oct 26.

Assistance Publique-Hôpitaux de Paris, Hôpital Henri Mondor, Créteil, France; Université Paris Est Créteil, Faculté de Médecine, Créteil, France; INSERM IMRB U955 Equipe 18, Créteil, France.

Background: Sorafenib is the recommended treatment for patients with advanced hepatocellular carcinoma. We aimed to compare the efficacy and safety of sorafenib to that of selective internal radiotherapy (SIRT) with yttrium-90 (Y) resin microspheres in patients with hepatocellular carcinoma.

Methods: SARAH was a multicentre, open-label, randomised, controlled, investigator-initiated, phase 3 trial done at 25 centres specialising in liver diseases in France. Patients were eligible if they were aged at least 18 years with a life expectancy greater than 3 months, had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, Child-Pugh liver function class A or B score of 7 or lower, and locally advanced hepatocellular carcinoma (Barcelona Clinic Liver Cancer [BCLC] stage C), or new hepatocellular carcinoma not eligible for surgical resection, liver transplantation, or thermal ablation after a previously cured hepatocellular carcinoma (cured by surgery or thermoablative therapy), or hepatocellular carcinoma with two unsuccessful rounds of transarterial chemoembolisation. Patients were randomly assigned (1:1) by a permutated block method with block sizes two and four to receive continuous oral sorafenib (400 mg twice daily) or SIRT with Y-loaded resin microspheres 2-5 weeks after randomisation. Patients were stratified according to randomising centre, ECOG performance status, previous transarterial chemoembolisation, and presence of macroscopic vascular invasion. The primary endpoint was overall survival. Analyses were done on the intention-to-treat population; safety was assessed in all patients who received at least one dose of sorafenib or underwent at least one of the SIRT work-up exams. This study has been completed and the final results are reported here. The trial is registered with ClinicalTrials.gov, number NCT01482442.

Findings: Between Dec 5, 2011, and March 12, 2015, 467 patients were randomly assigned; after eight patients withdrew consent, 237 were assigned to SIRT and 222 to sorafenib. In the SIRT group, 53 (22%) of 237 patients did not receive SIRT; 26 (49%) of these 53 patients were treated with sorafenib. Median follow-up was 27·9 months (IQR 21·9-33·6) in the SIRT group and 28·1 months (20·0-35·3) in the sorafenib group. Median overall survival was 8·0 months (95% CI 6·7-9·9) in the SIRT group versus 9·9 months (8·7-11·4) in the sorafenib group (hazard ratio 1·15 [95% CI 0·94-1·41] for SIRT vs sorafenib; p=0·18). In the safety population, at least one serious adverse event was reported in 174 (77%) of 226 patients in the SIRT group and in 176 (82%) of 216 in the sorafenib group. The most frequent grade 3 or worse treatment-related adverse events were fatigue (20 [9%] vs 41 [19%]), liver dysfunction (25 [11%] vs 27 [13%]), increased laboratory liver values (20 [9%] vs 16 [7%]), haematological abnormalities (23 [10%] vs 30 [14%]), diarrhoea (three [1%] vs 30 [14%]), abdominal pain (six [3%] vs 14 [6%]), increased creatinine (four [2%] vs 12 [6%]), and hand-foot skin reaction (one [<1%] vs 12 [6%]). 19 deaths in the SIRT group and 12 in the sorafenib group were deemed to be treatment related.

Interpretation: In patients with locally advanced or intermediate-stage hepatocellular carcinoma after unsuccessful transarterial chemoembolisation, overall survival did not significantly differ between the two groups. Quality of life and tolerance might help when choosing between the two treatments.

Funding: Sirtex Medical Inc.
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http://dx.doi.org/10.1016/S1470-2045(17)30683-6DOI Listing
December 2017

Evaluation of Doppler-ultrasonography in the diagnosis of transjugular intrahepatic portosystemic shunt dysfunction: A prospective study.

World J Hepatol 2017 Sep;9(27):1125-1132

Service d'Hépato-Gastroentérologie, Hôpital Trousseau, CHRU Tours, 37044 Tours, France.

Aim: To prospectively evaluate the performance of Doppler-ultrasonography (US) for the detection of transjugular intrahepatic portosystemic shunt (TIPS) dysfunction within a multicenter cohort of cirrhotic patients.

Methods: This study was conducted in 10 french teaching hospitals. After TIPS insertion, angiography and liver Doppler-US were carried out every six months to detect dysfunction (defined by a portosystemic gradient ≥ 12 mmHg and/or a stent stenosis ≥ 50%). The association between ultrasonographic signs and dysfunction was studied by logistic random-effects models, and the diagnostic performance of each Doppler criterion was estimated by the bootstrap method. This study was approved by the ethics committee of Tours.

Results: Two hundred and eighteen pairs of examinations performed on 87 cirrhotic patients were analyzed. Variables significantly associated with dysfunction were: The speed of flow in the portal vein ( = 0.008), the reversal of flow in the right ( = 0.038) and left ( = 0.049) portal branch, the loss of modulation of portal flow by the right atrium ( = 0.0005), ascites ( = 0.001) and the overall impression of the operator ( = 0.0001). The diagnostic performances of these variables were low; sensitivity was < 58% and negative predictive value was < 73%. Therefore, dysfunction cannot be ruled out from Doppler-US.

Conclusion: The performance of Doppler-US for the detection of TIPS dysfunction is poor compared to angiography. New tools are needed to improve diagnosis of TIPS dysfunction.
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http://dx.doi.org/10.4254/wjh.v9.i27.1125DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5620422PMC
September 2017

Embolisation of pulmonary radio frequency pathway - a randomised trial.

Int J Hyperthermia 2017 11 23;33(7):814-819. Epub 2017 Apr 23.

a Hopital de la Timone , Marseille , France.

Purpose: Pneumothorax is the most common complication following a pulmonary percutaneous radiofrequency ablation (RFA), and thoracic drainages are the most frequent causes of an extended hospital stay. Our main objective was to show that the use of gelatin torpedoes may significantly decrease the number of chest tube placement.

Materials And Methods: Seventy-three patients were prospectively included in this study and then randomised into two groups: 34 with embolisation and without 39 without embolisation. Each group was comparable for different pneumothorax risk factors.

Results: There were 16 (47%) pneumothorax in Group A ("with embolisation"), which was significantly lower (p < .0001) than the 35 pneumothorax (90%) in Group B ("without embolisation"). The pneumothorax volume (p = .02) was significantly lower in Group A (22.7% average, standard deviation 15.6%) than in Group B (average 34.1%, standard deviation 17.1%). The number of drainages was significantly smaller in those with embolisation (3 drainages or 8%) than those without embolisation (25 drainages or 64%) (p < .001).

Conclusion: When using absorbable gelatin torpedoes, pulmonary RFA pathways embolisation significantly decreased the number of pneumothorax and thoracic drainages to the advantage of therapeutic abstention and exsufflation, non-invasive and functional operational techniques.
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http://dx.doi.org/10.1080/02656736.2017.1309578DOI Listing
November 2017

Pathological effects of lung radiofrequency ablation that contribute to pneumothorax, using a porcine model.

Int J Hyperthermia 2017 11 17;33(7):713-716. Epub 2017 Apr 17.

a Hopital de la Timone , Marseille , France.

Objectives: The incidence of pneumothorax is 7 times higher after lung radiofrequency ablation (RFA) than after lung biopsy. The reasons for such a difference have never been objectified. The histopathologic changes in lung tissue are well-studied and established for RF in the ablation zone. However, it has not been previously described what the nature of thermal injury might be along the shaft of the RF electrode as it traverses through normal lung tissue to reach the ablation zone. The purpose of this study was to determine the changes occurring around the RF needle along the pathway between the ablated zone and the pleura.

Material And Methods: In 3 anaesthetised and ventilated swine, 6 RFA procedures (right and left lungs) were performed using a 14-gauge unipolar multi-tined retractable 3 cm radiofrequency LeVeen probe with a coaxial introducer positioned under CT fluoroscopic guidance. In compliance with literature guidelines, we implemented a gradually increasing thermo-ablation protocol using a RF generator. Helical CT images were acquired pre- and post-RFA procedure to detect and evaluate pneumothorax. Four percutaneous 19-gauge lung biopsies were also performed on the fourth swine under CT guidance. Swine were sacrificed for lung ex vivo examinations, scanning electron microscopy (SEM) and pathological analysis.

Results: Three severe (over 50 ml) pneumothorax were detected after RFA. In each one of them, pathological examination revealed a fistulous tract between ablation zone and pleura. No fistulous tract was observed after biopsies. In the 3 cases of severe pneumothorax, the tract was wide open and clearly visible on post procedure CT images and SEM examinations. The RFA tract differed from the needle biopsy tract. The histological changes that are usually found in the ablated zone were observed in the RFA tract's wall and were related to thermal lesions. These modifications caused the creation of a coagulated pulmonary parenchyma rim between the thermo-ablation zone and the pleural space. The structural properties of the damage can explain why the RFA tract is remains patent after needle withdrawal.

Conclusion: Our study demonstrates for the first time that the changes around the RF needle are the same as in the ablated zone. The damage could create fistulous tracts along the needle path between thermo-ablation zone and pleural space. These fistulas could certainly be responsible for severe pneumothorax that occurs in many patients treated with lung RFA.
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http://dx.doi.org/10.1080/02656736.2017.1309577DOI Listing
November 2017
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