Management of women with abnormal uterine bleeding: Clinical practice guidelines of the French National College of Gynaecologists and Obstetricians (CNGOF).

OBJECTIVE: To provide French guidelines for the management of women with abnormal uterine bleeding (AUB). DESIGN: A consensus committee of 26 experts was formed. A formal conflict-of-interest policy was developed at the beginning of the process and enforced throughout. The entire guidelines process was conducted independently of any industry funding (i.e. pharmaceutical or medical device companies). The authors were advised to follow the rules of the Grading of Recommendations Assessment, Development and Evaluation (GRADE®) system to guide assessment of quality of evidence. The potential drawbacks of making strong recommendations in the presence of low-quality evidence were emphasized. METHODS: The last guidelines from the Collège National des Gynécologues et Obstétriciens Français on the management of women with AUB were published in 2008. The literature seems now sufficient for an update. The committee studied questions within 7 fields (diagnosis; adolescents; idiopathic AUB; endometrial hyperplasia and polyps; type 0-2 fibroids; type 3 or higher fibroids; and adenomyosis). Each question was formulated in a PICO (Patients, Intervention, Comparison, Outcome) format and evidence profiles were compiled. The GRADE® methodology was applied to the literature review and the formulation of recommendations. RESULTS: The experts' synthesis work and the application of the GRADE method resulted in 36 recommendations. Among the formalized recommendations, 19 are strong and 17 weak. No response was found in the literature for 14 questions. We chose to abstain from recommendations rather than providing advice based solely on expert clinical experience. CONCLUSIONS: The 36 recommendations make it possible to specify the diagnostic and therapeutic strategies for various clinical situations practitioners encounter, from the simplest to the most complex.

[Management of women with abnormal uterine bleeding: Clinical practice guidelines of the French National College of Gynecologists and Obstetricians (CNGOF)]. / Prise en charge des ménorragies : recommandations pour la pratique clinique du Collège national des gynécologues et obstétriciens français (CNGOF).

OBJECTIVE: To provide French guidelines for the management of women with abnormal uterine bleeding (AUB). DESIGN: A consensus committee of 26 experts was formed. A formal conflict-of-interest (COI) policy was developed at the beginning of the process and enforced throughout. The entire guidelines process was conducted independently of any industrial funding (i.e. pharmaceutical, or medical devices). The authors were advised to follow the rules of the Grading of Recommendations Assessment, Development and Evaluation (GRADE®) system to guide assessment of quality of evidence. The potential drawbacks of making strong recommendations in the presence of low-quality evidence were emphasized. METHODS: The last guidelines from the Collège national des gynécologues et obstétriciens français (CNGOF) on the management of women with AUB was published in 2008. The literature seems now sufficient for an update. The committee studied questions within 7 fields (diagnosis; adolescent; idiopathic AUB; endometrial hyperplasia and polyps; fibroids type 0 to 2; fibroids type 3 and more; adenomyosis). Each question was formulated in a PICO (Patients, Intervention, Comparison, Outcome) format and the evidence profiles were produced. The literature review and recommendations were made according to the GRADE® methodology. RESULTS: The experts' synthesis work and the application of the GRADE method resulted in 36 recommendations. Among the formalized recommendations, 19 present a strong agreement and 17 a weak agreement. Fourteen questions did not find any response in the literature. We preferred to abstain from recommending instead of providing expert advice. CONCLUSIONS: The 36 recommendations made it possible to specify the diagnostic and therapeutic strategies of various clinical situations managed by the practitioner, from the simplest to the most complex.

Ergotism with acute limb ischemia, provoked by HIV protease inhibitors interaction with ergotamine, rescued by multisite transluminal balloon angioplasty.

Acute limb ischemia induced by arterial vasospasm remains an exceptional situation, favoured by the use of arterial vasoconstrictors. The risk of these substances is largely underestimated in the general population, especially with the co-administration of strong cytochrome inhibitors like human immunodeficiency virus (HIV) protease inhibitors. A 33-year-old woman, who used to take dihydroergotamine for orthostatic hypotension, was prescribed a post-exposure HIV prophylaxis including lopinavir and ritonavir. One day later, she presented an acute bilateral limb ischemia with a sudden pain in both calves, initially while walking and then at rest with bilateral ischemic toes. Angiography confirmed diffuse arterial vasospasm of the lower limb arteries. A first-line therapy with isosorbide dinitrate and amlodipine was ineffective, with rapid clinical worsening. A combination of intra-arterial injections and intra-venous infusions of vasodilators, transluminal balloon angioplasty and bilateral 4-Compartment fasciotomies permitted rapid improvement and finally resulted in both lower limbs rescue. This case and literature review illustrate ergotism due to ergotamine overdose after taking HIV protease inhibitors. It also demonstrates the benefit of an interventional procedure besides medical therapy with vasodilators in severe arterial vasospasm. All along the lower limb arterial tree, transluminal balloon angioplasty restored the blood flow, without vasospasm recurrence. CONCLUSION: In case of ergotism with acute lower limbs ischemia, combining medical vasodilator therapy with interventional procedure can restore the arterial blood flow, thus allowing to save lower limbs.

Impact of anatomy type of prostatic artery on the number of catheters needed for prostatic artery embolization.

PURPOSE: The purpose of this study was to assess the relationship between the number of microcatheters required for prostatic artery embolization (PAE) and the anatomy of the prostatic artery (PA). MATERIALS AND METHODS: All consecutive patients who underwent PAE between May 2017 and December 2018 were included. The anatomical description of the PAs was assessed by both global cone beam computed tomography and selective angiography and data on the resources used, in terms of microcatheters, were prospectively collected. RESULTS: A total of 215 consecutive patients (mean age, 66±8.7 [SD] years; range: 45-93 years), with a mean International Prostate Symptom Score of 21±7.4 (SD) and a mean prostate volume on magnetic resonance imaging of 88±38 (SD) mL (range: 30-200mL) underwent PAE. A single PA was observed in 347 hemipelvises (347/411; 84.4%) and double PAs in 64 (64/411; 15.6%). Eighty percent (173/215 patients) of PAEs were performed using a single microcatheter. Type I PA anatomy required significantly more microcatheters (1.15±0.39 [SD]; range: 1-3), than type II (1.04±0.19 [SD]; range: 1-2), type III (1.09±0.34 [SD]; range: 1-3) and type IV (1.06±0.27 [SD]; range: 1-2) (P=0.01 for all). CONCLUSION: PAE is feasible with limited per-intervention changes in devices for all types of PA anatomy encountered. This could help in the design of appropriate reimbursement policies in various healthcare settings.

3D-printed face protective shield in interventional radiology: Evaluation of an immediate solution in the era of COVID-19 pandemic.

PURPOSE: The purpose of this study was to report the clinical evaluation of a 3D-printed protective face shield designed to protect interventional radiologists from droplet transmission of the SARS-Cov-2. MATERIALS AND METHODS: A protective face shield consisting in a standard transparent polymerizing vinyl chloride (PVC) sheet was built using commercially available 3D printers. The 3D-printed face shield was evaluated in 31 interventional procedures in terms of ability to perform the assigned intervention as usual, quality of visual comfort and tolerance using a Likert scale (from 1, as very good to 5, as extremely poor). RESULTS: The mean rating for ability to perform the assigned intervention as usual was 1.7±0.8 (SD) (range: 1-4). The mean visual tolerance rating was 1.6±0.7 (SD) (range: 1-4). The mean tolerability rating was 1.4±0.7 (SD) (range: 1-3). CONCLUSION: The 3D-printed protective face shield is well accepted in various interventions. It may become an additional option for protection of interventional radiologists.

Mid-Term Results of Superior Rectal Artery and Coils for Hemorrhoidal Embolization with Particles Bleeding.

OBJECTIVES: To compare safety and clinical outcomes of embolization of the superior rectal arteries in patients with hemorrhoidal bleeding using particles and coils versus coils only. METHODS: We retrospectively reviewed data for patients undergoing embolization for chronic hemorrhoidal bleeding from January 2014 to April 2017. Embolization was performed with coils alone or with particles and coils. Clinical scores (Paris bleeding severity score, Goligher classification and quality of life score) were obtained, and embolization was performed with microparticles (300-500 µm) followed by fibered pushable coils. Clinical success was defined as an improvement of > 2 points in the Paris bleeding severity score, without complications. Outcomes were compared between the two groups in a matched-pairs analysis (1:1 scenario), with patients embolized with particles and coils as the study group and patients embolized with coils alone as the control. RESULTS: We treated 45 consecutive patients. After matched-pairs analysis, the final study population was 38 patients (19 study group and 19 controls). Clinical success did not differ significantly between the two populations: 63% for control group and 68% for the study group (p = 0.790). The median change in clinical score was - 3 [- 6; - 1] for the control group and - 3 [- 4; - 1] for the study group (p = 0.187). Grade 1 complications were reported in 15% of patients, with no major complications. CONCLUSIONS: Embolization was feasible, with a technical success of 100% and no major complications. Clinical success was obtained in 66% in patients with no difference when using combined embolization with particles and coils versus coils only.

Endovascular Extra-Anatomic Femoro-Popliteal Bypass for Limb Salvage in Chronic Critical Limb Ischemia.

PURPOSE: To report the initial clinical experience with fully endovascular extra-anatomic femoro-popliteal bypass (FPB) for limb salvage in patients with critical limb ischemia (CLI) and no traditional endovascular or surgical revascularization options. METHODS: Between June 2013 and May 2018, endovascular procedure was proposed for limb salvage during multidisciplinary team meeting in fifteen hospitalized patients (median age 67 years; 73% men) with CLI and a high risk of major amputation. Primary outcome was amputation-free survival at 1 year. Secondary outcomes included mortality, cardiovascular (CV) events and major limb amputation at 1 year, primary/secondary bypass patency and wound healing at the last follow-up visit. Procedure-related complications (deaths, CV events, hemorrhages) were recorded through 30 days. RESULTS: Technical procedure success rate was 100%. Major peri-procedural outcomes occurred in two patients (13%): One patient died secondary to cardiogenic shock; one patient suffered acute coronary syndrome associated with iliopsoas bleeding. No major amputation occurred through 30 days. Median follow-up period was 21.5 (18.25-45.5) months (last follow-up visits on April 2019). Amputation-free survival at 1-year and at the last follow-up visit was 80% and 53%, respectively. Cumulative mortality at 1-year and at the last follow-up visit was 13% and 33%, respectively. Primary and secondary bypass patency was 27% and 60%, respectively. Complete wound healing was achieved in 11 patients (73%). CONCLUSION: Endovascular extra-anatomic FPB represents an innovative approach for limb salvage in CLI with no traditional endovascular or surgical revascularization options. Our clinical experience highlights that this technique remains challenging because of frequent comorbidities and fragility of this patient population. LEVEL OF EVIDENCE: Level 4, Case series.

Study of the intra-prostatic arterial anatomy and implications for arterial embolization of benign prostatic hyperplasia.

INTRODUCTION: Prostatic arterial embolization (PAE) is an experimental therapy for benign prostatic hyperplasia. Its feasibility is based on the knowledge of the pelvic arterial anatomy, and more specifically the prostate. The aim of this study was to describe the prostatic arterial supply: origins, distribution and variability. MATERIAL AND METHODS: We reviewed retrospectively, with two radiologists, 40 arteriographies of patients who underwent PAE in our center. With these observations of 80 hemipelvics, we described the number of prostatic arteries, their origins, their distributions and eventually their anastomoses with other pelvic arteries. RESULTS: There was one prostatic artery in 70% of the cases. It came from a common trunk for the prostate and the bladder in 55% of the cases, from the obturator artery in 17.5% of the cases, from the pudendal artery in 25% of the cases, from the intern iliac artery in 1% of the cases, and from the superior gluteal artery in 1% of the cases. The prostatic artery splitted in two branches (medial and lateral), with no anastomoses in 37% of the cases. Anastomoses with penile and rectal arteries were observed in 29% of the cases. CONCLUSIONS: For our 40 patients, we observed many variations of arterial prostatic anatomy. We proposed a classification in order to increase security and efficacy of PAE, and it should be validated with more patients. LEVEL OF EVIDENCE: 2.

Correction to: Percutaneous Deep Venous Arterialization for Severe Critical Limb Ischemia in Patients With No Option of Revascularization: Early Experience From Two European Centers.

The fifth author's name was incorrectly published as "M. Messas". The correct name is "E. Messas". The original article has been corrected.

Percutaneous Deep Venous Arterialization for Severe Critical Limb Ischemia in Patients With No Option of Revascularization: Early Experience From Two European Centers.

PURPOSE: To report our initial experience of fully percutaneous deep venous arterialization (pDVA) for the treatment of chronic critical limb ischemia (cCLI) after failed distal angioplasty. MATERIALS AND METHODS: pDVA was performed in five consecutive patients by creating an arteriovenous fistula (AVF) between a below the knee artery and its satellite deep vein. In this early experience, only patients with failed prior interventional attempts at establishing flow with no distal targets for an arterial bypass were selected. Early technical success was defined as successful AVF creation and retrograde venous perfusion of the wound site. Patient demographics, procedural details, morbidity/mortality and wound healing outcomes were assessed prospectively. Patients were followed up in wound care centers, and graft patency was documented on duplex ultrasound. RESULTS: All five consecutive patients (mean age 58 years) underwent successful pDVA without any procedural complications. There were neither 30-day major adverse limb events nor major cardiovascular complications. Three out of the five patients (60%) had clinical improvement as observed by resolution of rest pain and complete wound healing. At the 1-month FU, one patient died and one patient received a major amputation. The median wound healing time was 39 weeks. CONCLUSION: pDVA is a safe and feasible vascularization alternative in patients with end-stage/no-option CLI. The early experience highlights the need for a multidisciplinary approach including a dedicated wound care service.

Comparison of Two Endovascular Steerable Robotic Catheters for Percutaneous Robot-Assisted Fibroid Embolization.

PURPOSE: To compare outcomes of percutaneous robot-assisted uterine fibroid embolization (UFE) using two different endovascular robotic catheters. METHODS: Twenty-one patients with a symptomatic uterine fibroid were prospectively enrolled in a single-center study to be treated with a percutaneous robot-assisted embolization using the Magellan system. Fourteen patients were treated using a first generation steerable robotic catheter, version 1.0 (group 1), and seven were treated using the new version 1.1 (group 2). Demographic, pathologic, and procedural variables were recorded. Dose Area Product (DAP) and physician equivalent doses were registered for each procedure. Procedural related complications and clinical midterm outcomes were also evaluated. RESULTS: Successful robot-assisted UFE was obtained in eight patients (57.1%) in group 1 and 7 patients (100%) in group 2 (p = 0.01). A successful robot-assisted catheterization of the internal iliac artery anterior branch was performed in all patients of both groups. Median selective target vessel catheterization time was 21.0 ± 12.8 vs 13.4 ± 7 min (p = 0.04) and total fluoroscopy time was 30.3 ± 11.2 vs 19.3 ± 5.9 min, respectively, in group 1 and 2. Mean DAP decreased from 18472.6 ± 15622 to 5469.1 ± 4461.0 cGy·cm2 (p = 0.04). All patients obtained a symptoms relief at 6 months follow-up. CONCLUSIONS: Robot-assisted uterine fibroid embolization is safe and effective. New version of steerable robotic catheter allows performing a faster procedure without related adverse events compared to old version.

[Recanalization procedure of the common femoral vein following iatrogenic femoral chronic occlusion: 3 cases]. / Recanalisation veineuse des membres inférieurs sur occlusion fémorale chronique iatrogène : à propos de 3 cas.

Common femoral vein occlusion (CFVO) is frequently found in patients with chronic venous insufficiency. The iatrogenic form, secondary to either central catheter or surgery, is very rare but highly symptomatic. Classical compression therapy barely improves the clinical status of these patients, making them suitable candidates for an interventional procedure for venous recanalization. METHODS: We report here three consecutive cases of iatrogenic CFVO referred to our outpatient clinic because the disease had an impact on daily life activities. We detail the recanalization procedure, the Doppler control and the short-term outcome. RESULTS: In each case, endovascular recanalization required rigid material (rigid guide or Colapinto needle) to cross the fibrous adhesions before angioplasty could be performed with stenting. The procedure required two attempts in each case, underlining its complexity, but eventually enabled effective recanalization. No major complication occurred per- or post-procedure. One month later, a duplex Doppler control confirmed the permeability of the common femoral vein. The patients had experienced rapid and significant symptom improvement. CONCLUSION: Patients suffering from severe chronic venous insufficiency caused by iatrogenic CFVO can benefit from endovascular recanalization. Although these procedures may be complex due to the extensive fibrosis at the Scarpa and require specialized equipment, no major complications were observed. Patency of the recanalization persisted at least one month after the procedure. Symptom relief was good.

Percutaneous radiofrequency ablation of lung metastases from colorectal carcinoma under C-arm cone beam CT guidance.

PURPOSE: The aim of this study was to assess the feasibility, safety and efficacy of percutaneous radiofrequency ablation of lung metastases from colorectal carcinoma using C-arm cone beam computed tomography (CBCT) guidance. MATERIAL AND METHODS: This single-center prospective observational study was performed from August 2013 to August 2016, and included consecutive patients referred for radiofrequency ablation of lung metastases from colorectal cancer. Radiofrequency ablation procedures were performed under C-arm CBCT guidance. Feasibility was assessed by probe accuracy placement, time to accurate placement and number of C-arm CBCT acquisitions to reach the target lesion. Safety was assessed by the report of adverse event graded using the common terminology criteria for adverse events (CTCAE-V4.0). Efficacy was assessed by metastases response rate using RECIST 1.1 and 18FDG-PET-CT tumor uptake at 6months. RESULTS: Fifty-four consecutive patients (32 men, 22 women) with a mean age of 63±8 (SD) years (range: 51-81years) with a total of 56 lung metastasis from colorectal metastases were treated in a single session. The mean tumor diameter was 25.6±4.5 (SD)mm (range: 17-31mm). Median time to insert the needle into the target lesion was 10min (range: 5-25min). Median number of needles repositioning and C-arm CBCT acquisition per patient was 1 (range: 0-3) and 4 (range: 3-6) respectively. The accuracy for radiofrequency ablation probe placement was 2±0.2 (SD)mm (range: 0-9mm). Pneumothorax requiring chest tube placement occurred in one patient (CTCAE-V4.0 grade 3). At 6months, all patients were alive with tumor response rate of -27% and had no significant activity on the 18FDG-PET CT follow-up. CONCLUSION: Percutaneous radiofrequency ablation of lung metastases from colorectal cancer under C-arm CBCT guidance is feasible and safe, with immediate and short-term results similar to those obtained using conventional CT guidance.

Embolization of the superior rectal arteries for chronic bleeding due to haemorrhoidal disease.

AIM: The aim of this study was to assess the safety and efficacy of the emborrhoid technique (embolization of the superior haemorrhoidal arteries) in patients ineligible for surgery. METHODS: Between January 2014 and April 2015, 30 consecutive patients (average age 58 years) suffering from disabling chronic bleeding due to haemorrhoidal disease and with a contraindication for surgery (n = 23) or with a failure of instrumental or surgical treatment (n = 7) underwent embolization. All cases were discussed at multidisciplinary meetings including a proctology specialist or a surgeon and an interventional radiologist. We performed super selective micro coil embolization (pushable 2-3 mm fibre coils) of the distal branches of the superior rectal arteries with a microcatheter, via a right femoral approach, under local anaesthesia. We assessed clinical outcome by evaluating bleeding and specific clinical scores relating to bleeding and changes in quality of life. RESULTS: Immediate technical success, with no complication, was achieved in 93% of cases. A mean of 3.1 arteries per patient was embolized, with a mean of 7.6 coils per patient. Median follow-up was 5 months. Clinical score improvement was observed in 72%, in 17 patients after a single embolization session, and in four additional patients after a second embolization session. No improvement in bleeding was observed in eight patients (28%). CONCLUSION: Distal coil embolization of the superior rectal arteries for disabling chronic bleeding due to haemorrhoidal disease is safe and effective in patients untreatable by surgery.

Safety and efficacy of superior rectal artery embolization with particles and metallic coils for the treatment of hemorrhoids (Emborrhoid technique).

PURPOSE: The purpose of this study was to comprehensively evaluate the short-term outcomes after percutaneous embolization of the superior rectal artery (SRA) with metallic coils and particles for the management of hemorrhoids. MATERIALS AND METHODS: Forty patients (15 men, 25 women) with a mean age of 35±5 years (SD) (range: 25-65 years) were prospectively enrolled. All patients had symptomatic hemorrhoids. The distribution of internal hemorrhoids was as follows: grade I (n=6, 16%); grade II (n=28, 69%) and grade III (n=6; 15%). All patients had percutaneous embolization of the SRA with metallic coils and synthetic polyvinyl alcohol particles. Follow-up evaluation included clinical examination, rectoscopy, histopathological analysis of rectal mucosa, duplex Doppler blood flow quantification, electromyography, sphincterometry of the anal sphincter and analysis of patient satisfaction. RESULTS: No immediate complications were observed and no patients had anal pain syndrome after embolization. Hemorrhoids showed a 43% size reduction after embolization (P<0.05). Taking into account the symptom resolutions such as irritation, discomfort, bloody discharge and pain, satisfaction was observed in 5/6 (83%) patients with grade III hemorrhoids and 32/34 patients (94%) with grades I-II hemorrhoids. One month after embolization, anal sphincter contractility normalized and no changes in anal electromyography were observed. Blood flow in the hemorrhoidal plexus dropped from 109±1.2ml/min/100g (SD) before treatment to 60.2±4.4ml/min/100g (SD) (P<0.05) the day after embolization and remained unchanged one month after embolization. CONCLUSION: Our study demonstrates that embolization of SRA with particle and coils does not lead to ischemia in patients with symptomatic hemorrhoids. Short-term results with regard to symptom management for hemorrhoidal disease are very encouraging and should stimulate further prospective and multicenter studies.

[Therapeutic endovascular procedures in aortitis]. / Place du traitement endovasculaire dans les aortites inflammatoires.

Aortitis is an inflammation of the aortic wall with an infectious or non-infectious origin, which often progresses to vascular complications. The open surgical approach is a high-risk procedure for these pathologies. Endovascular interventions have improved the prognosis of patients with aortitis complications. This manuscript describes the pathophysiology responsible for vascular complications and the role of endovascular approach for their treatment.

Proximal Scallop in Thoracic Endovascular Aortic Aneurysm Repair to Overcome Neck Issues in the Arch.

OBJECTIVE: To evaluate initial experience with a custom made proximal scalloped stent graft for thoracic endovascular aortic repair (TEVAR) of aortic aneurysms involving the arch. METHODS: Between September 2012 and November 2014, patients presenting with a thoracic aortic aneurysm (TAA) with short or angulated neck were selected for treatment by custom made proximal scalloped Relay Plus stent grafts (ABS Bolton Medical, Barcelona, Spain). Prospectively acquired data relating to patient demographics, procedure details, clinical outcomes, and complications were analyzed retrospectively. RESULTS: Ten selected patients (50% male, mean age 77 ± 8 years) were treated using a thoracic custom made Relay Plus stent graft, three of whom underwent additional cervical supra-aortic trunk revascularizations. TAA were fusiform in four cases, saccular in three, and three patients were treated for proximal type I endoleaks after previous standard TEVAR. The graft was landed in zone 2 in 3 cases, in zone 1 in 4 cases, and in zone 0 in 3 cases. The custom made scallop was designed to preserve flow in the left subclavian artery in three patients, in the left common carotid artery in four, and in the innominate artery in three. No proximal type I endoleak occurred and proximal sealing was achieved in all cases, with a technical success rate of 100%. All targeted vessels were patent. During a mean follow up of 12 ± 5 months, no conversion to open surgical repair and no aortic rupture occurred. One patient died post-operatively from myocardial infarction and one patient suffered a stroke with complete recovery. One patient had a distal type I endoleak on the 6 month CT scan and is scheduled for distal extension. No paraplegia, retrograde dissection and no other aortic related complications were recorded. CONCLUSIONS: Proximal scalloped stent grafts appear to be an effective additional tool for TEVAR of TAA when dealing with short or angulated proximal necks.