Publications by authors named "Marc Sapoval"

120 Publications

Renal artery variations in patients with mild-to-moderate hypertension from the RADIANCE-HTN SOLO trial.

Cardiovasc Revasc Med 2021 Sep 30. Epub 2021 Sep 30.

Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY, USA.

Purpose: To assess the variability of renal artery (RA) anatomy and presence of RA-pathology in patients with mild-to-moderate hypertension enrolled in the RADIANCE-HTN SOLO trial.

Background: RADIANCE-HTN SOLO was a multicenter, international, blinded, randomized, sham-controlled trial evaluating ultrasound-based endovascular renal denervation (RDN) in patients with mild-to-moderate hypertension while off antihypertensive medications.

Methods: Eligible subjects had pre-randomization renal CT- or MR- angiography (CTA, MRA) to confirm anatomic suitability and to define RA ablation sites. All images were sent for independent review for evaluation of RA anatomy and other vascular pathology.

Results: A total of 324 patients underwent RA imaging (282 CTA and 42 MRA). Of those, 178 had simple anatomy with a single left and single right RA with mean diameters of 5.4 ± 0.9 and 5.1 ± 0.8 mm and mean lengths of 40.0 ± 12.9 and 52.0 ± 13.1 mm, respectively. Twenty-seven patients (8.3%) had unilateral or bilateral dual RAs with mean diameters of 4.0 ± 0.9 mm on the left and 3.9 ± 0.9 mm on the right. Forty percent (129/324) of patients had at least 1 accessory RA, with mean accessory diameters of 2.4 ± 0.8 mm on the left and 2.3 ± 0.8 mm on the right. Twenty-eight patients (8.6%) had at least 1 short (<25 mm) main RA. Incidental findings included: 9 patients (2.8%) with atherosclerotic RA stenosis ≥30%, 9 patients (2.8%) with fibromuscular dysplasia of RA and 2 patients (0.6%) with kidney and adrenal gland tumors.

Conclusions: Pre-procedure CTA or MRA imaging is a valuable aid in assessing RA anatomy prior to RDN because of variable RA anatomy. CTA or MRA may detect RA lesions, and renal or adrenal tumors which may need additional workup prior to consideration of RDN.

Clinical Trial Registration: ClinicalTrials.gov NCT02649426.
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http://dx.doi.org/10.1016/j.carrev.2021.09.008DOI Listing
September 2021

Insights from intravascular pressure measurement of renal artery revascularization in patients with fibromuscular dysplasia: the DYSART study.

J Vasc Surg 2021 Sep 30. Epub 2021 Sep 30.

Department of Radiology, La Timone Hospital, Marseille, France.

Objective: The indication of percutaneous renal transluminal angioplasty (PTRA) in fibromuscular dysplasia (FMD) is mainly based on renal artery stenosis (RAS) due to atherosclerosis criteria, which are not specific to FMD. Consequently, the selection of patients who could benefit from this treatment and its effectiveness remain uncertain. The aims of this study were to: (1) report the effects of PTRA guided by trans-stenotic pressure measurements on hypertension 7 months after treatment; (2) assess the impact of pressure measurement to guide treatment efficacy in comparison to visual angiographic parameters; and (3) evaluate the reproducibility and accuracy of the stenosis measurement using a 4F catheter in comparison to a pressure guidewire.

Methods: This prospective multi-centric study analyzed 24 patients with hypertension with RAS due to FMD that required PTRA. Clinical, duplex ultrasound, and angiographic indices were collected, and patients were followed up for 7 months (±1 month). Angiographic indices were measured twice both by a pressure guidewire and a 4F catheter. Assessment of procedural and clinical success of angioplasty was performed for all patients.

Results: Twenty-three patients (96%) had procedural success (considered as a post-PTRA translesional systolic gradient ≤10 mmHg or reduced by at least 80%) with a significant decrease in the systolic gradient after angioplasty (26.50 mmHg; [interquartile range, 16.75-38.75] vs 0.00 [interquartile range, 0.00-2.00]; P < .01). Three patients (12%) had complications, including two renal artery dissections and one partial renal infarction. Twenty-one patients (88%) were clinical responders to angioplasty at follow-up. Visual stenosis assessment showed a poor correlation with systolic gradient measurement before and after PTRA (R from -0.05 to 0.41; P = 0.06-0.82). High correlations were found between pressure measurements made by a 4F catheter and guidewire (R from 0.64 to 0.89; P ≤ .003).

Conclusions: In patients selected by clinical indicators and duplex ultrasound, reaching a translesional systolic gradient ≤10 mmHg or reduced by at least 80% after angioplasty, promotes a high success rate for PTRA in hypertension due to FMD RAS.
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http://dx.doi.org/10.1016/j.jvs.2021.09.023DOI 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

Prostate artery chemoembolization in prostate cancer: A proof of concept study in spontaneous prostate cancer in a canine model.

Diagn Interv Imaging 2021 Aug 11. Epub 2021 Aug 11.

Université de Paris, PARCC, INSERM, 75006 Paris; Department of Interventional Radiology, Hôpital Européen Georges Pompidou, Assistance Publique - Hôpitaux de Paris, 75015 Paris, France.

Purpose: The purpose of this study was to assess the feasibility and efficacy of docetaxel-loaded bead chemoembolization in spontaneous prostate cancer in a canine model.

Materials And Methods: Five pet dogs with histopathologically proven prostate cancer were referred for prostate artery chemoembolization (PACE). After PACE, all animals were followed, including pharmacokinetic study and clinical and biological evolution, until death. Pelvic contrast-enhanced computed tomography examination was performed at one and two months. Animals were subjected to pathological examination after death.

Results: Both prostate arteries were successfully chemoembolized in all dogs. A median dose of 18 mg (Q1, Q3; 11.8, 20 mg) docetaxel loaded in 3 mL of 50-100 µm super absorbent polymer beads was injected into each dog. At one month, four of the five dogs were still alive and the median prostate volume was 51% lower (prePACE median prostate volume, 18.4 mL [Q1, Q3; 12, 32.1 mL] vs. postPACE median prostate volume, 6.2 mL [Q1, Q3; 6.2, 11 mL]). At two months, three dogs died because of disease progression. The two remaining dogs showed a 70% median decrease in prostate volume. Prostate pathological examination showed 73% of necrosis. No worsening of urinary symptoms was observed. Pharmacokinetic analysis showed limited systemic passage of docetaxel. All dogs died of metastatic spread at nine months.

Conclusion: This study suggests that PACE is feasible and safe for the treatment of spontaneous prostate cancer in a canine model and may provide a new approach to treat selected patients with prostate cancer.
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http://dx.doi.org/10.1016/j.diii.2021.07.003DOI Listing
August 2021

Splenic embolization in trauma: results of a survey from an international cohort.

Emerg Radiol 2021 Oct 11;28(5):955-963. Epub 2021 Jun 11.

University of Minnesota, 420 Delaware Street SE, Minneapolis, MN, 55455, USA.

Purpose: A questionnaire regarding splenic embolization in trauma was submitted to an international sample of IR faculty members, to compare their practice to the available recommendations.

Methods: A 21 multiple-choice questionnaire was sent to an international cohort of 96 IR faculty. Questions included the initial patient evaluation, embolization materials and techniques, post-procedure management, availability of an institutional protocol, and use of guidelines.

Results: For each question, there were from a minimum of 45 to a maximum of 52 responders: 94% require a CT with contrast prior to embolization, and 87% use the American Association for the Surgery of Trauma (AAST) scale to grade the splenic injuries. Embolization is performed across all values of the AAST scale. Of the patients with injuries of grade III or greater, embolization is primarily done for those patients who are hemodynamically stable. Unstable patients are embolized less frequently and primarily in cases in which the injuries are of a lower grade. Coils are the preferred material for proximal embolization (69%). Particles/Gelfoam is the preferred material for distal embolization (38%). In total, 63% administer intravenous antibiotics before the procedure and 15% administer intra-arterial antibiotics during the procedure. After embolization, follow-up imaging is recommended by 87%, antibiotics are administered regularly by 33%, clinical follow-up is recommended by 73%, and vaccination against encapsulated organisms is routinely recommended by 39%.

Conclusions: There is significant variability among a heterogeneous cohort of respondents. Available recommendations may not be sufficiently addressing the practice of splenic embolization.
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http://dx.doi.org/10.1007/s10140-021-01929-yDOI Listing
October 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

Randomised trial of first-line bronchial artery embolisation for non-severe haemoptysis of mild abundance.

BMJ Open Respir Res 2021 06;8(1)

Department of Clinical Pharmacology and Clinical Research Platform of East of Paris (URC-CRC-CRB), Hôpital St Antoine, Paris, France, Assistance Publique-Hôpitaux de Paris (AP-HP), Sorbonne Université, Paris, France.

Background: Whereas first-line bronchial artery embolisation (BAE) is considered standard of care for the management of severe haemoptysis, it is unknown whether this approach is warranted for non-severe haemoptysis.

Research Question: To assess the efficacy on bleeding control and the safety of first-line BAE in non-severe haemoptysis of mild abundance.

Study Design And Methods: This multicentre, randomised controlled open-label trial enrolled adult patients without major comorbid condition and having mild haemoptysis (onset <72 hours, 100-200 mL estimated bleeding amount), related to a systemic arterial mechanism. Patients were randomly assigned (1:1) to BAE associated with medical therapy or to medical therapy alone.

Results: Bleeding recurrence at day 30 after randomisation (primary outcome) occurred in 4 (11.8%) of 34 patients in the BAE strategy and 17 (44.7%) of 38 patients in the medical strategy (difference -33%; 95% CI -13.8% to -52.1%, p=0.002). The 90-day bleeding recurrence-free survival rates were 91.2% (95% CI 75.1% to 97.1%) and 60.2% (95% CI 42.9% to 73.8%), respectively (HR=0.19, 95% CI 0.05 to 0.67, p=0.01). No death occurred during follow-up and no bleeding recurrence needed surgery.Four adverse events (one major with systemic emboli) occurred during hospitalisation, all in the BAE strategy (11.8% vs 0%; difference 11.8%, 95% CI 0.9 to 22.6, p=0.045); all eventually resolved.

Conclusion: In non-severe haemoptysis of mild abundance, BAE associated with medical therapy had a superior efficacy for preventing bleeding recurrences at 30 and 90 days, as compared with medical therapy alone. However, it was associated with a higher rate of adverse events.

Trial Registration Number: NCT01278199.
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http://dx.doi.org/10.1136/bmjresp-2021-000949DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8183216PMC
June 2021

Ultrasound renal denervation for hypertension resistant to a triple medication pill (RADIANCE-HTN TRIO): a randomised, multicentre, single-blind, sham-controlled trial.

Lancet 2021 Jun 16;397(10293):2476-2486. Epub 2021 May 16.

Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY, USA.

Background: Endovascular renal denervation reduces blood pressure in patients with mild-to-moderate hypertension, but its efficacy in patients with true resistant hypertension has not been shown. We aimed to assess the efficacy and safety of endovascular ultrasound renal denervation in patients with hypertension resistant to three or more antihypertensive medications.

Methods: In a randomised, international, multicentre, single-blind, sham-controlled trial done at 28 tertiary centres in the USA and 25 in Europe, we included patients aged 18-75 years with office blood pressure of at least 140/90 mm Hg despite three or more antihypertensive medications including a diuretic. Eligible patients were switched to a once daily, fixed-dose, single-pill combination of a calcium channel blocker, an angiotensin receptor blocker, and a thiazide diuretic. After 4 weeks of standardised therapy, patients with daytime ambulatory blood pressure of at least 135/85 mm Hg were randomly assigned (1:1) by computer (stratified by centres) to ultrasound renal denervation or a sham procedure. Patients and outcome assessors were masked to randomisation. Addition of antihypertensive medications was allowed if specified blood pressure thresholds were exceeded. The primary endpoint was the change in daytime ambulatory systolic blood pressure at 2 months in the intention-to-treat population. Safety was also assessed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT02649426.

Findings: Between March 11, 2016, and March 13, 2020, 989 participants were enrolled and 136 were randomly assigned to renal denervation (n=69) or a sham procedure (n=67). Full adherence to the combination medications at 2 months among patients with urine samples was similar in both groups (42 [82%] of 51 in the renal denervation group vs 47 [82%] of 57 in the sham procedure group; p=0·99). Renal denervation reduced daytime ambulatory systolic blood pressure more than the sham procedure (-8·0 mm Hg [IQR -16·4 to 0·0] vs -3·0 mm Hg [-10·3 to 1·8]; median between-group difference -4·5 mm Hg [95% CI -8·5 to -0·3]; adjusted p=0·022); the median between-group difference was -5·8 mm Hg (95% CI -9·7 to -1·6; adjusted p=0·0051) among patients with complete ambulatory blood pressure data. There were no differences in safety outcomes between the two groups.

Interpretation: Compared with a sham procedure, ultrasound renal denervation reduced blood pressure at 2 months in patients with hypertension resistant to a standardised triple combination pill. If the blood pressure lowering effect and safety of renal denervation are maintained in the long term, renal denervation might be an alternative to the addition of further antihypertensive medications in patients with resistant hypertension.

Funding: ReCor Medical.
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http://dx.doi.org/10.1016/S0140-6736(21)00788-1DOI Listing
June 2021

Gastrointestinal Hemorrhages in Patients With COVID-19 Managed With Transarterial Embolization.

Am J Gastroenterol 2021 04;116(4):838-840

1UOC Radiologia, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Itlay; 2Vascular and Oncological Interventional Radiology, Hopital Georges Pompidou, Paris, France; 3UO Radiologia, ASST Settelaghi, Ospedale di Circolo e Fondazione Macchi, Varese, Italy; 4Radiology Department, University Radiology Unit, Sant'Anna University Hospital, Ferrara, Italy; 5Department of Experimental, Diagnostic and Speciality Medicine, UO Radiologia, Sant'Orsola Hospital, University of Bologna, Bologna, Italy; 6Hôpitaux de Paris (AP-HP), Service d'Imagerie Médicale, CHU Henri Mondor, Créteil, France; 7Instituto de Investigaciones Sanitarias RyC, Research coordinator at Vascular and Interventional Service, Ramón y Cajal University Hospital, Madrid, Spain; 8CHU Djon, Dijon, France; 9Department of Health Sciences, Università degli Studi di Milano, Milan, Italy.

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http://dx.doi.org/10.14309/ajg.0000000000000978DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7553031PMC
April 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

"Ranger BTK" a Prospective Single-Centre Cohort Study on a New Drug-Coated Balloon for Below the Knee Lesions in Patients with Critical Limb Ischemia.

Cardiovasc Intervent Radiol 2021 Jul 4;44(7):1017-1027. Epub 2021 May 4.

Université de Paris, INSERM U970, 75015, Paris, France.

Purpose: Restenosis remains a limitation of endovascular angioplasty with a patency of 30% in BTK at 12 months. Several studies on drug-coated balloons have not demonstrated any improvements in terms of patency and target lesions revascularization in BTK lesions. This prospective single-centre cohort study evaluates the safety and efficacy of a new generation low-dose drug-coated balloon (DCB) with a reduced crystalline structure to treat below the knee (BTK) lesions in patients with critical limb ischemia (CLI).

Materials And Methods: Between November 2016 and November 2017, 30 consecutive patients (mean 68.8 ± 12.7 years, 6 female) with BTK lesions and CLI were included in this single-centre, prospective non-randomized cohort study. All patients with rest pain and/or ischemic wound associated with BTK lesions were included in the study. Mean lesion length was 133.6 ± 94.5 mm and 18(60%) were chronic total occlusions. The primary safety outcome parameter was a composite of all-cause mortality and major amputation at 6 months. The primary efficacy outcome parameter was the primary angiographic patency at 6 months (defined as freedom from clinically driven target lesion revascularization and the absence of significant restenosis (> 50%) as determined by core laboratory angiography assessment. Immediate technical success, late lumen loss (LLL), clinical target lesion revascularization (TLR) and ulcer healing rates at 12 months were also evaluated.

Results: Immediate technical success was 97%(29/30): one patient had an acute thrombosis at the completion of index procedure. Primary safety outcome parameter was 94%(28/30): one patient underwent major amputation and one patient died of other comorbidities at 2 months. Another patient had a major amputation at 7.5 months. Angiographic follow-up was available in 20 patients. Primary angiographic patency was 57%(12/21 lesions), and LLL was 0.99 ± 0.68 mm at 6 months. Freedom from TLR was 89% at 12 months. The rate of ulcer healing was 76% at 12 months.

Conclusion: Ranger DCB balloons to treat CLI patients demonstrated a positive trend with good safety outcomes parameters. Further randomized studies are needed to understand the usefulness compared to POBA.
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http://dx.doi.org/10.1007/s00270-021-02833-1DOI Listing
July 2021

Endovascular therapies for pulmonary embolism.

Heliyon 2021 Apr 1;7(4):e06574. Epub 2021 Apr 1.

Service d'imagerie CHU Toulouse, Rangueil, France.

Purpose: The aim of this article is to define the place of new endovascular methods for the management of pulmonary embolisms (PE), on the basis of a multidisciplinary consensus.

Method And Results: Briefly, from the recent literature, for high-risk PE presenting with shock or cardiac arrest, systemic thrombolysis or embolectomy is recommended, while for lowrisk PE, anticoagulation alone is proposed. Normo-tense patients with PE but with biological or imaging signs of right heart dysfunction constitute a group known as "at intermediate risk" for which the therapeutic strategy remains controversial. In fact, some patients may require more aggressive treatment in addition to the anticoagulant treatment, because approximately 10% will decompensate hemodynamically with a high risk of mortality. Systemic thrombolysis may be an option, but with hemorrhagic risks, particularly intra cranial. Various hybrid pharmacomechanical approaches are proposed to maintain the benefits of thrombolysis while reducing its risks, but the overall clinical experience of these different techniques remains limited. Patients with high intermediate and high risk pulmonary embolism should be managed by a multidisciplinary team combining the skills of cardiologists, resuscitators, pneumologists, interventional radiologists and cardiac surgeons. Such a team can determine which intervention - thrombolysis alone or assisted, percutaneous mechanical fragmentation of the thrombus or surgical embolectomy - is best suited to a particular patient.

Conclusions: This consensus document define the place of endovascular thrombectomy based on an appropriate risk stratification of PE.
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http://dx.doi.org/10.1016/j.heliyon.2021.e06574DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8047492PMC
April 2021

Association between intravesical prostatic protrusion and clinical outcomes in prostatic artery embolization.

Diagn Interv Imaging 2021 Mar 7;102(3):141-145. Epub 2021 Jan 7.

Department of Vascular and Oncological Interventional Radiology, AP-HP, centre, Hôpital Européen Georges-Pompidou, 75015 Paris, France; Université de Paris, 75006 Paris, France; INSERM URM 970 équipe 2 Imagerie de l'Angiogenèse, 75015 Paris, France.

Purpose: To evaluate the influence of intravesical prostatic protrusion (IPP) on clinical outcomes after prostatic artery embolization (PAE) in patients with lower urinary tract symptoms due to benign prostatic hyperplasia.

Materials And Methods: All consecutive patients who underwent PAE for lower urinary tract symptoms between January 2017 and January 2019 were retrospectively included. IPP was evaluated on pre-treatment magnetic resonance imaging examination and symptoms were assessed at follow-up consultations using the international prostate symptom score (IPSS) and quality of life (QOL) questionnaire. IPPs were classified as grade 1 (<5mm), grade 2 (5-10mm), or grade 3 (>10mm).

Results: A total of 160 consecutive men (mean age 65±7.8 [SD] years; range: 45-89 years), underwent PAE. The mean IPSS was 21±7.3 (SD) (range: 5-35) and prostate volume 87±38 (SD) mL (range: 30-200mL). The IPP grade was 1 for 28 (28/160; 18%), 2 for 52 (52/160; 33%), and 3 for 80 (80/160; 50%) patients. There were no significant differences in IPSS at baseline between the three IPP grades. Patients with severe (grade 3) IPP had a significantly higher reduction in IPSS than those with non-severe IPP (grade 1 or 2), with estimated mean reductions of 12±2.5 (SD) (range: -4-28) and 8.3±1.9 (SD) (range: -8-21) (P=0.02), respectively. The mean reduction in the QOL score was 3.0 for grade 3 and 2.0 for grade 1 or 2 IPP (P=0.02).

Conclusions: The degree of IPP does not limit the efficacy of PAE in patients with lower urinary tract symptoms due to benign prostatic hyperplasia.
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http://dx.doi.org/10.1016/j.diii.2020.12.003DOI Listing
March 2021

12-Month Results From the Unblinded Phase of the RADIANCE-HTN SOLO Trial of Ultrasound Renal Denervation.

JACC Cardiovasc Interv 2020 12;13(24):2922-2933

Columbia University Medical Center/NewYork-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, New York, USA.

Objectives: This study reports the 12-month results of the RADIANCE-HTN (A Study of the ReCor Medical Paradise System in Clinical Hypertension) SOLO trial following unblinding of patients at 6 months.

Background: The blood pressure (BP)-lowering efficacy and safety of endovascular ultrasound renal denervation (RDN) in the absence (2 months) and presence (6 months) of antihypertensive medications were previously reported.

Methods: Patients with daytime ambulatory BP ≥135/85 mm Hg after 4 weeks off medication were randomized to RDN (n = 74) or sham (n = 72) and maintained off medication for 2 months. A standardized medication escalation protocol was instituted between 2 and 5 months (blinded phase). Between 6 and 12 months (unblinded phase), patients received antihypertensive medications at physicians' discretion. Outcomes at 12 months included medication burden, change in daytime ambulatory systolic BP (dASBP) and office or home systolic BP (SBP), visit-to-visit variability in SBP, and safety.

Results: Sixty-five of 74 RDN patients and 67 of 72 sham patients had 12-month dASBP measurements. The proportion of patients on ≥2 medications (27.7% vs. 44.8%; p = 0.041), the number of medications (0 vs. 1.4; p = 0.015), and defined daily dose (1.4 vs. 2.2; p = 0.007) were less with RDN versus sham. The decrease in dASBP from baseline in the RDN group (-16.5 ± 12.9 mm Hg) remained stable at 12 months. The RDN versus sham adjusted difference at 12 months was -2.3 mm Hg (95% confidence interval [CI]: -5.9 to 1.3 mm Hg; p = 0.201) for dASBP, -6.3 mm Hg (95% CI: -11.1 to -1.5 mm Hg; p = 0.010) for office SBP, and -3.4 mm Hg (95% CI: -6.9 to 0.1 mm Hg; p = 0.062) for home SBP. Visit-to-visit variability in SBP was smaller in the RDN group. No renal artery injury was detected on computed tomographic or magnetic resonance angiography.

Conclusions: Despite unblinding, the BP-lowering effect of RDN was maintained at 12 months with fewer prescribed medications compared with sham.
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http://dx.doi.org/10.1016/j.jcin.2020.09.054DOI Listing
December 2020

Bridge to surgery after irinotecan-based liver chemoembolization for metastatic gastric adenocarcinoma: Letter to the editor.

Clin Res Hepatol Gastroenterol 2021 09 2;45(5):101557. Epub 2020 Nov 2.

Department of Interventional Radiology, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, 75015 Paris, France; Université de Paris, Descartes-Paris 5, 75006 Paris, France.

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http://dx.doi.org/10.1016/j.clinre.2020.08.018DOI Listing
September 2021

Reperfusion therapies in pulmonary embolism-state of the art and expert opinion: A position paper from the "Unité de Soins Intensifs de Cardiologie" group of the French Society of Cardiology.

Arch Cardiovasc Dis 2020 Nov 22;113(11):749-759. Epub 2020 Sep 22.

Intensive Care Unit, Department of Cardiology, Hôpital Nord, AP-HM, Aix-Marseille Université, 13015 Marseille; Mediterranean Association for Research and Studies in Cardiology (MARS Cardio), 13000 Marseille, France; INSERM 1263, 1260, Centre for Cardiovascular and Nutrition Research (C2VN), INRA, 13385 Marseille, France. Electronic address:

Acute pulmonary embolism is a frequent cardiovascular emergency with an increasing incidence. The prognosis of patients with high-risk and intermediate-high-risk pulmonary embolism has not improved over the last decade. The current treatment strategies are mainly based on anticoagulation to prevent recurrence and reduce pulmonary vasculature obstruction. However, the slow rate of thrombus lysis under anticoagulation is unable to acutely decrease right ventricle overload and pulmonary vasculature resistance in patients with severe obstruction and right ventricle dysfunction. Therefore, patients with high-risk and intermediate-high-risk pulmonary embolism remain a therapeutic challenge. Reperfusion therapies may be discussed for these patients, and include systemic thrombolysis, catheter-directed therapies and surgical thrombectomy. High-risk patients require systemic thrombolysis, but may have contraindications as a result of the high risk of bleeding. In addition, intermediate-high-risk patients should not receive systemic thrombolysis, despite its high efficacy, because of prohibitive bleeding complications. Recently, percutaneous reperfusion techniques have been developed to acutely decrease pulmonary vascular obstruction with lower-dose or no thrombolytic agents and, thus, potentially higher safety than systemic thrombolysis. Some of these techniques improve key haemodynamic variables. Cardiac surgical techniques and venoarterial extracorporeal membrane oxygenation as temporary circulatory support may be useful in selected cases. The development of pulmonary embolism centres with multidisciplinary pulmonary embolism teams is mandatory to enable adequate use of reperfusion and improve outcomes. We aim to present the state of the art regarding reperfusion therapies in pulmonary embolism, but also to provide guidance on their indications and patient selection.
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http://dx.doi.org/10.1016/j.acvd.2020.06.002DOI Listing
November 2020

Proposal for a New Score: Hemorrhoidal Bleeding Score.

Ann Coloproctol 2021 Oct 18;37(5):311-317. Epub 2020 Sep 18.

Service de Proctologie Médico-Chirurgicale, GH Paris Saint-Joseph, Paris, France.

Purpose: We conducted a prospective study to evaluate a new hemorrhoidal bleeding score (HBS).

Methods: All consecutive patients who had consulted between May 1, 2016 and June 30, 2017 for bleeding hemorrhoidal disease were prospectively assessed at a proctological department. The study was conducted in 2 stages. The first stage assessed the validity of the score on a prospective patient cohort. A second stage assessed the interobserver reproducibility of the score on another prospective cohort.

Results: One hundred consecutive patients were studied (57 males; mean age, 49.70 years). A positive association between HBS and surgery indication was found (P<0.001). A cut-off value of the score of 5 (≤5 vs. >5) separated patients from surgical to medical-instrumental treatment with a sensitivity and specificity of 75.00% and 81.25%, respectively. In the multivariate analysis, only HBS was significantly associated with the operative decision (odds ratio, 12.22). Prolapse was no longer significantly associated with the surgical indication. After a mean follow-up after treatment of 7 months, HBS improved statistically significantly (P<0.0001). For the reproducibility of the score, an additional 30 consecutive patients (13 males; mean age, 53.14 years) were enrolled with an excellent agreement between 2 proctologists (kappa=0.983).

Conclusion: HBS is sensitive, specific, and reproducible. It can assess the severity of hemorrhoidal bleeding. It can discriminate between the most severe surgery-indicated patients and does so in a more efficient way than the Goligher prolapse score. It also allows quantifying the extent of change in hemorrhoidal bleeding after treatment.
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http://dx.doi.org/10.3393/ac.2020.08.19DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8566148PMC
October 2021

More Evidence Support PAE: Results of Sham Comparison.

Cardiovasc Intervent Radiol 2020 11 7;43(11):1738-1739. Epub 2020 Aug 7.

Department of Interventional Radiology, Guy's and St Thomas Hospitals NHS Foundation Trust, London, SE1 9RT, UK.

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http://dx.doi.org/10.1007/s00270-020-02513-6DOI Listing
November 2020

Non-invasive recanalization of deep venous thrombosis by high frequency ultrasound in a swine model with follow-up.

J Thromb Haemost 2020 11 6;18(11):2889-2898. Epub 2020 Sep 6.

Physics for Medicine Paris, INSERM U1273, ESPCI Paris, CNRS FRE 2031, PSL Research University, Paris, France.

Aims: Pulsed cavitational ultrasound therapy (thombotripsy) allows the accurate fractionation of a distant thrombus. We aimed to evaluate the efficacy and safety of non-invasive thrombotripsy using a robotic assisted and high frequency ultrasound approach to recanalize proximal deep venous thrombosis (DVT) in a swine model.

Methods: Occlusive thrombosis was obtained with a dual jugular and femoral endoveinous approach. The therapeutic device was composed of a 2.25 MHz focused transducer centered by a linear ultrasound probe, and a robotic arm. The feasibility, security, and efficacy (venous channel patency) assessment after thrombotripsy was performed on 13 pigs with acute occluded DVT. To assess the mid-term efficacy of this technique, 8 pigs were followed up for 14 days after thrombotripsy and compared with 8 control pigs. The primary efficacy endpoint was the venous patency. Safety was assessed by the search for local vessel wall injury and pulmonary embolism.

Results: We succeeded in treating all pigs except two with no accessible femoral vein. After median treatment duration of 23 minutes of cavitation, all treated DVT were fully recanalized acutely. At 14 days, in the treated group, six of the eight pigs had a persistent patent vein and two pigs had a venous reocclusion. In the control group all pigs had a persistent venous occlusion. At sacrifice, no local vein nor arterial wall damage were observed as well as no evidence of pulmonary embolism in all pigs.

Conclusion: High frequency thrombotripsy seems to be effective and safe for non-invasive venous recanalization of DVT.
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http://dx.doi.org/10.1111/jth.15034DOI Listing
November 2020

Repeat Prostatic Artery Embolization.

J Vasc Interv Radiol 2020 Jul 10;31(7):1090-1095.e1. Epub 2020 Jun 10.

Interventional Radiology Department, Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, 20, rue Leblanc, 75015 Paris, France.

This is a single-center retrospective analysis of 3 patients (mean age, 61 y ± 8.6) who underwent repeat prostatic artery (PA) embolization (PAE; rPAE) because of clinical failure after PAE. Revascularization of the central gland through a recanalized PA was the most frequent pattern observed (5 of 7; 71.4%), followed by revascularization through penile collateral vessels (2 of 7; 28.6%). Technical success during rPAE was achieved in 5 hemiprostates (83.3%). Clinical success at 6 months after rPAE was achieved in 2 of 3 patients (66.6%). Implications of these findings could be valuable to those performing PAE.
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http://dx.doi.org/10.1016/j.jvir.2020.03.012DOI Listing
July 2020

Prostatic Artery Embolization Allows to Maintain Full Sexual Activity in Patients Suffering from Bothersome Lower Urinary Tracts Symptoms related to Benign Prostatic Hyperplasia.

Cardiovasc Intervent Radiol 2020 Aug 3;43(8):1202-1207. Epub 2020 Jun 3.

Faculté de Médecine, Université Paris V: René Descartes, Paris, France.

Introduction: The effect of prostate artery embolization (PAE) on male sexual function is currently the subject of debate in the literature. The main purpose of this study was to define changes in all domains of sexual activity after PAE, using the international index of erectile function score (IIEF-15).

Methods: A single-center retrospective study was conducted on 129 patients (mean age of 65.5 ± 7 years), who underwent PAE from February 2014 to January 2017 for symptomatic benign prostatic hyperplasia (BPH). Fifty consecutive patients fulfilling the inclusion criteria were evaluated before and after PAE follow-up using the IIEF-15, IPSS, prostate volume (PV) and cardiovascular risk factor and BPH drugs. The IIEF-15 domains analyzed were: erectile function (EF) ejaculation and orgasm (Ej/O), sexual desire (SD), intercourse satisfaction (IS) and overall satisfaction (OS). A paired sample t test or Wilcoxon signed-rank test was used to compare IIEF-15 between baseline and follow-up.

Results: The study showed nonsignificant change in IIEF-15 total score (58.0 ± 13.8 SD; p = 0.71) and the five domains (EF 24.5 ± 7.0 SD, p = 0.82; EJ/O 8.2 ± 2.3 SD, p = 0.50; SD 7.2 ± 2.7 SD, p = 0.57; IS 10.3 ± 3.0 SD, p = 0.77; OS 8.2 ± 2.7 SD; p = 0.11) after PAE. We also found a significant improvement in IPSS score after PAE.

Conclusion: Based on the IIEF-15 questionnaire, PAE was showed to allow good urinary symptoms results and no deterioration in sexual function.
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http://dx.doi.org/10.1007/s00270-020-02520-7DOI Listing
August 2020

Contrast-Enhanced Ultrasonography for the Early Evaluation of Prostate Artery Embolization.

Cardiovasc Intervent Radiol 2020 Oct 20;43(10):1498-1504. Epub 2020 May 20.

Department of Interventional Radiology, Hôpital Européen Georges Pompidou, AP-HP, Université de Paris-Descartes Paris 5, Paris, 75015, France.

Aim: To prospectively evaluate the feasibility and reproducibility of the semiquantitative measurement of the unenhanced area of the prostate by trans-abdominal contrast-enhanced ultrasound (CEUS) performed immediately after prostate artery embolization (PAE) as a prognostic factor of success.

Methods: Thirty-nine patients with PAE were prospectively included. They all underwent pre- and post-PAE trans-abdominal prostate CEUS. Two readers independently evaluated the pre- and post-PAE unenhanced area using a semiquantitative method: unenhanced areas were measured on 3 different slices (basis, middle, and apex) and reported to the whole prostate area. The mean of the three measures was reported semiquantitatively in classes of ten percent and quartiles. We evaluated correlation with clinical success, at 3 months after PAE, defined as a > 25% reduction in the International Prostatic Symptoms Score and a Quality of life < 3.

Results: Twenty-three patients who had bilateral PAE were analyzed. Pre-PAE trans-abdominal prostate CEUS showed visible early and marked enhancement of the entire prostate in all patients. After PAE, all patients had a semiquantitatively measured unenhanced area > 25%. The semiquantitative measurement was found to be highly reproducible, with an interclass correlation > 0.8. No correlation was found between the area of unenhanced tissue and clinical success evaluated at 3 months.

Conclusion: Trans-abdominal prostate CEUS performed early after PAE provides reproducible results and is a valuable tool to evaluate unenhanced areas of the prostate.

Level Of Evidence: 3, local non random sample.
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http://dx.doi.org/10.1007/s00270-020-02518-1DOI Listing
October 2020

Four-Year Impact of Voiding and Storage Symptoms in Patients with Benign Prostatic Hyperplasia Treated with Prostatic Artery Embolization.

J Vasc Interv Radiol 2020 Sep 24;31(9):1460-1466. Epub 2020 Feb 24.

Department of Interventional Radiology, Assistance publique Hopitaux de Paris, Hôpital Européen Georges-Pompidou, Paris, France; Université Paris Descartes, Sorbonne Paris-Cité, Paris, France; Institut national de la santé et de la recherche médicale U970, Paris, France.

Purpose: To study the subscore improvement in International Prostate Symptom Scores (IPSS) after prostatic artery embolization (PAE).

Materials And Methods: A single-center retrospective study was carried out with follow-up from December 2013 to July 2019 in 37 consecutive patients (66.0 ± 8.8 years old) who underwent PAE, comparing resultant scores before and after PAE. IPSS were divided into storage (IPSS-s) subscores and voiding (IPSS-v) subscores. The changes between IPSS-s and IPSS-v at 1, 3, 6, and 12 months' follow-up as well as the last follow-up were compared with baseline scores. The changes in percentages of IPSS-s and IPSS-v and the changes in average IPSS-s-to-total IPSS ratios (IPSS-s/IPSS-t) and IPSS-v-to-IPSS-t ratios (IPSS-v/IPSS-t) were also analyzed.

Results: In the study population, consisting of 37 patients, IPSS-t significantly decreased from 16.5 ± 7.2 at baseline to 8.3 ± 5.7 at the last follow-up (4 years later) (P < .0001). Additionally, the changes in IPSS-v symptoms were greater than the changes in IPSS-s symptoms at 1, 3, 6, and 12 months' follow-up, reaching a statistical significance at 6 months with a decrease of 72.9% ± 42.4% for IPSS-v and a decrease of 50.1% ± 52.2% for IPSS-s (P = .009).

Conclusions: PAE can successfully reduce both IPSS-s and IPSS-v with predominant IPSS-v reduction. The improvements in both subscores were sustained for up to 4 years of follow-up.
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http://dx.doi.org/10.1016/j.jvir.2019.08.034DOI Listing
September 2020

Does Bead Size Affect Patient Outcome in Irinotecan-Loaded Beads Chemoembolization Plus Systemic Chemotherapy Regimens for Liver-Dominant Colorectal Cancer? Results of an Observational Study.

Cardiovasc Intervent Radiol 2020 Jun 26;43(6):866-874. Epub 2020 Feb 26.

Interventional Radiology Department, Hôpital Européen Georges Pompidou, 20 Rue Leblanc, 75015, Paris, France.

Purpose: We investigated the clinical effects of bead size in irinotecan-loaded beads chemoembolization (DEBIRI) used for treating liver-dominant colorectal cancer.

Materials And Methods: Between March 2009 and January 2018, all consecutive patients with colorectal cancer liver metastases referred for DEBIRI at our tertiary center were included in an observational study. Patients were treated exclusively with either 100-mg irinotecan-loaded DC beads of 70-150 μm (small bead group or SB) or 100-300 μm (large bead group or LB) in diameter, in addition to systemic therapy. Liver tumor response rate at 3 months, liver and overall progression-free survival (PFS) and overall survival were estimated.

Results: In total, 84 patients with liver-dominant progressive disease underwent 232 DEBIRI sessions. Fifty-four patients were treated in the SB group and 30 patients in the LB group. Liver progression-free rates at 3 months were 86.7% for the LB group and 79.6% for the SB group (NS). Median liver-PFS and overall PFS were, respectively, 7.15 months and 7.15 months for the LB group and 7.65 and 7.55 months for the SB group (NS). Median overall survival was 13.04 months for the LB group and 15.59 months for the SB group (p = 0.04). Specific treatment grade 3 + 4 toxicity occurrence was 5 (17%) in the LB group and 20 (37%) in the SB group.

Conclusion: No significant difference in patient outcome was observed between DEBIRI bead sizes of 70-150 μm and 100-300 μm. A trend toward higher treatment-specific toxicity was observed with the smaller beads.
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http://dx.doi.org/10.1007/s00270-020-02438-0DOI Listing
June 2020

CIRSE Standards of Practice on Prostatic Artery Embolisation.

Cardiovasc Intervent Radiol 2020 02 2;43(2):176-185. Epub 2019 Dec 2.

Department of Radiology, University of Sao Paulo Medical School, São Paulo, Brazil.

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http://dx.doi.org/10.1007/s00270-019-02379-3DOI Listing
February 2020

Development of Research Agenda in Prostate Artery Embolization: Summary of Society of Interventional Radiology Consensus Panel.

J Vasc Interv Radiol 2020 Jan 23;31(1):108-113. Epub 2019 Nov 23.

Department of Radiology, MedStar Georgetown University, Washington, DC.

Purpose: To summarize the Society of Interventional Radiology Foundation's Research Consensus Panel development of a research agenda on prostate artery embolization (PAE).

Materials And Methods: PAE for the treatment of lower urinary tract symptoms has been shown to be safe and effective in decreasing symptoms and prostate size. Lack of randomized controlled trials (RCTs) on PAE in the United States has prevented inclusion in American Urologic Association guideline recommendations for treatment of lower urinary tract symptoms resulting from benign prostatic hyperplasia. Recognizing the need for well-designed trials, the SIR Foundation funded a Research Consensus Panel to prioritize a research agenda. The panel included interventional radiologists, urologists, SIR Foundation leadership, and industry representatives. The goal of the meeting was to discuss weaknesses with current data and study design for development of US trials to report long-term outcomes data.

Results: Final consensus on a research design could not be made because the group was split on 3 research designs: (i) RCT of PAE versus sham with crossover of the sham group. (ii) RCT of PAE versus simple prostatectomy. (iii) RCT of PAE versus holmium laser enucleation of the prostate/thulium laser enucleation of the prostate. The panel recommended a nonindustry-funded registry to obtain real-world data.

Conclusions: Level 1 data are required to be included in the American Urologic Association guidelines for treatment of benign prostatic hyperplasia. Because of concerns with all 3 study designs, the panel did not reach a consensus. Further meetings are planned with the panel to select among these research designs.
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http://dx.doi.org/10.1016/j.jvir.2019.09.019DOI Listing
January 2020

Resistant Hypertension and Atherosclerotic Renal Artery Stenosis: Effects of Angioplasty on Ambulatory Blood Pressure. A Retrospective Uncontrolled Single-Center Study.

Hypertension 2019 12 28;74(6):1516-1523. Epub 2019 Oct 28.

Hypertension Unit, AP-HP, Hôpital Européen Georges-Pompidou, 75015, Paris, France (A.L., G.B., N.D., M.A., L.A.).

The effect of renal artery angioplasty on blood pressure in patients with true resistant hypertension and atherosclerotic renal artery stenosis has not been fully investigated due to the exclusion of these patients from most trials. In this study, we assessed the benefits of renal angioplasty on daytime ambulatory blood pressure (dABP) in this subgroup of patients. Medical records of our hypertension department were retrospectively analyzed from 2000 to 2016. Seventy-two patients were identified with resistant hypertension (dABP >135 or 85 mm Hg despite at least 3 antihypertensive drugs, including a diuretic) and atherosclerotic renal artery stenosis treated by angioplasty. Atherosclerotic renal artery stenosis was unilateral in 57 patients and bilateral in 15 patients. The mean age of the patients was 67.8±11.2 years; dABP was 157±16/82±10 mm Hg despite 4.0±1.0 antihypertensive treatments; estimated glomerular filtration rate was 52 (41-63) mL/min. After renal angioplasty, dABPM decreased by 14.0±17.3/6.4±8.7 mm Hg (<0.001 for both), and the number of antihypertensive treatments decreased to 3.6±1.4 (=0.002) with no significant change in estimated glomerular filtration rate. A high baseline systolic dABP and a low body mass index were independent predictors of systolic dABP changes. The decrease in dABP was confirmed in a subgroup of patients at one and 3 years of follow-up (N=31 and N=18 respectively, ≤0.001 for systolic and diastolic blood pressure at both visits). In this retrospective uncontrolled single-center study, angioplasty in patients with atherosclerotic renal artery stenosis and with true resistant hypertension significantly decreased dABP, reducing the need for antihypertensive treatment with no change in estimated glomerular filtration rate.
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http://dx.doi.org/10.1161/HYPERTENSIONAHA.119.13393DOI Listing
December 2019

New European Regulation for Medical Devices: What Is Changing?

Cardiovasc Intervent Radiol 2019 Sep 23;42(9):1272-1278. Epub 2019 May 23.

Vascular and Oncological Interventional Radiology Department Assistance Publique - Hôpitaux de Paris,, Hôpital Européen Georges Pompidou, 20, rue Leblanc, 75015, Paris, France.

Introduction: The Medical Devices Regulation (MDR) 2017/745/EU will fully apply from May 2020. Interventional radiologists use medical devices on a daily basis and so must be aware of the impact that this new regulation will have on their daily practice.

Materials And Methods: In this paper, we describe the major transformation that the MDR brings to the medical devices sector, with a focus on clinical evaluations and clinical investigations.

Results: This regulation significantly tightens controls to ensure that devices are safe and effective. In addition, equivalence to already existing devices, which allowed an accelerated access to the market, will now be possible only in some cases. Furthermore, post-marketing clinical follow-up is extended under the MDR and is required for all devices. These new requirements will probably lead to a dramatic increase in the number of clinical investigations and also to a delay in the availability of certain devices on the market.

Conclusions: In the coming years, interventional radiologists are likely to be affected by these changes in their daily practice, in terms of medical device availability and/or in terms of increased involvement in clinical investigations.
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http://dx.doi.org/10.1007/s00270-019-02247-0DOI Listing
September 2019

Prostate Artery Embolization in Patients With Acute Urinary Retention.

Am J Med 2019 11 17;132(11):e786-e790. Epub 2019 May 17.

Interventional Radiology Department, Assistance Publique - Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Paris, France.

Background: This prospective study assessed the efficacy of prostate artery embolization after failure of a trial without catheter in patients suffering a first episode of acute urinary retention as a result of benign prostatic hyperplasia (BPH).

Methods: Patients with failure of a trial without catheter despite alpha-blocker therapy were invited to participate in this protocol. Twenty patients were included in the study, and all underwent prostate artery embolization with calibrated polyvinyl alcohol (PVA) microspheres (Bead Block, BTG Ltd., Farnham, UK).

Results: Successful removal of the indwelling bladder catheter and spontaneous voiding was achieved in 15 of 20 (75%) patients, and the overall clinical success at 6 months after prostate embolization was 14 of 20 (70%). No patient experienced severe adverse events.

Conclusions: Prostate artery embolization might be a valuable treatment after a failure of a trial without catheter. Further studies are needed to better define its place in this setting.
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http://dx.doi.org/10.1016/j.amjmed.2019.04.037DOI Listing
November 2019
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