Patient-Reported Outcomes of Endovascular Treatment of Post-Thrombotic Syndrome: Ancillary Study of a French Cohort.

Excellent outcomes of angioplasty/stenting for the post-thrombotic syndrome (PTS) have been reported, notably regarding objective criteria in the vast French SFICV cohort. Differences may exist between patient-reported and objective outcomes. We investigated this possibility by using validated scales because significative correlations are discordant in the literature between patency and patient-reported characteristics. Patient-reported outcomes seem to be a more consistent tool than radiologic patency for the diagnosis and follow-up of patients displaying PTS. We retrospectively reviewed the Villalta scale and 20-item ChronIc Venous dIsease quality-of-life Questionnaire (CIVIQ-20) scores recorded after endovascular stenting for PTS at 14 centres in France in 2009-2019. We also collected patency rates, pre-operative post-thrombotic lesion severity, and the extent of stenting. We performed multivariate analyses to identify factors independently associated with improvements in each of the two scores. The 539 patients, including 324 women and 235 men, had a mean age of 44.7 years. The mean Villalta scale improvement was 7.0 ± 4.7 (p < 0.0001) and correlated with the thrombosis sequelae grade and time from thrombosis to stenting. The CIVIQ-20 score was available for 298 patients; the mean improvement was 19.2 ± 14.8 (p < 0.0001) and correlated with bilateral stenting, single thrombosis recurrence, and single stented segment. The objective gains demonstrated in earlier work after stenting were accompanied by patient-reported improvements. The factors associated with these improvements differed between the Villalta scale and the CIVIQ-20 score. These results proved that clinical follow-up with validated scores is gainful in patients treated for PTS thanks to a mini-invasive procedure.

Short- and Mid-Term Outcomes of Endovascular Stenting for the Treatment of Post-Thrombotic Syndrome due to Iliofemoral and Caval Occlusive Disease: A Multi-Centric Study from the French Society of Diagnostic and Interventional Cardiovascular Imaging (SFICV).

PURPOSE: To assess the results of endovascular treatment in a large population of patients suffering from post-thrombotic syndrome (PTS) due to iliocaval occlusive disease. METHODS: In this retrospective multi-center study, 698 patients treated by stenting for PTS in 15 French centers were analyzed. Primary, primary assisted, and secondary patency rates were assessed, and clinical efficacy was evaluated using Villalta and Chronic Venous Insufficiency Questionnaire in 20 questions (CIVIQ-20) scores. Outcomes were compared against pre-operative CT-based severity of the post-thrombotic lesions in the thigh (4 grades). RESULTS: Technical success, defined as successful recanalization and stent deployment restoring rapid anterograde flow in the targeted vessel, was obtained in 668 (95.7%) patients with a complication rate of 3.9%. After a mean follow-up of 21.0 months, primary patency, primary assisted patency, and secondary patency were achieved in 537 (80.4%), 566 (84.7%), and 616 (92.2%) of the 668 patients, respectively. Venous patency was strongly correlated to the grade of post-thrombotic changes in the thigh, with secondary patency rates of 96.0%, 92.9%, 88.4%, and 78.9%, respectively, for grades 0 to 3 (p = .0008). The mean improvements of Villalta and CIVIQ-20 scores were 7.0 ± 4.7 points (p < .0001) and 19.1 ± 14.8 points (p < .0001), respectively. CONCLUSION: Endovascular stenting as a treatment option for PTS due to chronic iliocaval venous occlusion generates a high technical success, low morbidity, high midterm patency rate, and clinical improvement. Venous patency was strongly correlated to the severity of post-thrombotic lesions in the thigh.

Complications of peripherally inserted central catheters in adult hospitalized patients and outpatients in the KTFIXPICC study: A randomized controlled trial evaluating a fixation device KT FIX Plussystem.

BACKGROUND: Poor securement potentiates Peripherally inserted central catheters (PICC) complications. A dressing device (KT FIX Plus) offers stronger skin attachment, which may reduce the risk of dressing disruption. We aimed to evaluate this device. METHODS: We conducted a single-center parallel-group open-label randomized controlled trial. Hospitalized and outpatient consecutive adults requiring PICCs were randomized to KT FIX Plus or standard of care (SOC). The primary endpoint was the composite of PICC-associated complications until removal, including occlusion, migration, accidental withdrawal, infection, thrombosis, and hematoma. RESULTS: No statistically significant difference was observed in terms of complications: 67 (35%) in the KT FIX Plus group vs 36 (37%) in the SOC group (log-rank P = 0.76). In multivariate Cox analysis, independent risk factors for PICC-associated complications were obesity (adjusted hazard ratio (aHR), 1.08, P < .001) and diabetes (aHR, 1.85, P = .039), adjusting for chronic renal failure, number of lumens, catheter/vein diameter ratio and duration of home-based care. Multiple lumen catheters increased the risk of accidental withdrawal and migration (HR, 2.4, P = .008). CONCLUSIONS: In our study, the use of KT FIX Plus did not reduce the risk of complications adjusting for other risk factors such as obesity and diabetes. The number of catheter lumens is one of the modifiable factors to reduce complications. Further studies are required to find the best securement and dressing system.

The use of cardiac computed tomography angiography in the assessment of percutaneous left atrial appendage closure - Review and experts recommendations endorsed by the Société française d'imagerie cardiaque et vasculaire diagnostique et interventionnelle.

Atrial fibrillation is the most common cause of arrhythmia which is responsible for over 15% of ischemic strokes, most of these being secondary to migration of a left atrial appendage (LAA) thrombus. In patient with contraindication to anticoagulant therapy, percutaneous closure system placement may be indicated. Cardiac computed tomography (CT) angiography plays a central role in the initial assessment as well as in the follow-up. The purpose of the pre-implantation cardiac CT angiography is to evaluate the anatomy of the LAA in order to select the most suitable prosthesis and check for any contraindication to device implantation. Image analysis is divided into four steps that include analysis of the approach; search for a thrombus in the LAA; investigation of the anatomy of the LAA (morphology of the LAA, dimensions of the LAA and choice of device) and cardiac and thoracic assessments. Follow-up involves CT examination to check for correct placement of the device and to detect any complications. On the basis of the results of currently available published research, a panel of experts has issued recommendations regarding cardiac CT angiography prior to percutaneous LAA closure device placement, which were further endorsed by the Société française d'imagerie cardiaque et vasculaire diagnostique et interventionnelle (SFICV).

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

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.

Combination of Model for End-Stage Liver Disease and Lactate Predicts Death in Patients Treated With Salvage Transjugular Intrahepatic Portosystemic Shunt for Refractory Variceal Bleeding.

BACKGROUND AND AIMS: Data about the prognosis of salvage transjugular intrahepatic portosystemic shunt (TIPS) using covered stents for refractory variceal bleeding caused by portal hypertension are scarce. We aimed to assess survival and to identify predictors of mortality in these patients. APPROACH AND RESULTS: One hundred sixty-four patients with cirrhosis from five centers treated with salvage TIPS between 2007 and 2017 were retrospectively divided into a derivation cohort (83 patients) and a validation cohort (81 patients). Comparisons were performed using the Mann-Whitney and Fischer's exact test. Six-week overall survival (OS) was correlated with variables on the day of the TIPS using Kaplan-Meier curves with log-rank test and univariate/multivariate analyses using the Cox model. Eighty-three patients were included in the derivation cohort (male, 78%; age, 55 years, alcohol-associated cirrhosis, 88%; Model for End-Stage Liver Disease [MELD], 19 [15-27]; arterial lactate, 3.7 mmol/L [2.0-8.3]). Six-week OS rate was 58%. At multivariate analysis, the MELD score (OR, 1.064; 95% CI, 1.005-1.126; P = 0.028) and arterial lactate (OR, 1.063; 95% CI, 1.013-1.114; P = 0.032) were associated with 6-week OS. Six-week OS rates were 100% in patients with arterial lactate ≤2.5 mmol/L and MELD score ≤ 15 and 5% in patients with lactate ≥12 mmol/L and/or MELD score ≥ 30. The 81 patients of the validation cohort had similar MELD and arterial lactate level but lower creatinine level (94 vs 106 µmol/L, P = 0.008); 6-week OS was 67%. Six-week OS rates were 86% in patients with arterial lactate ≤2.5 mmol/L and MELD score ≤ 15 and 10% for patients with lactate ≥12 mmol/L and/or MELD score ≥ 30. In the overall cohort, rebleeding rate was 15.8% at 6 weeks, and the acute-on-chronic liver failure grade (OR, 1.699; 95% CI, 1.056-1.663; P = 0.040) was independently associated with rebleeding. CONCLUSIONS: After salvage TIPS, 6-week mortality remains high and can be predicted by MELD score and lactate. Survival rate at 6 weeks was >85% in patients with arterial lactate ≤2.5 mmol/L and MELD score ≤ 15, while mortality was >90% for lactate ≥12 mmol/L and/or MELD score ≥ 30.

[Varicoceles, pelvic varices and pelvic congestion syndrome: Interventional radiology in diagnosis and treatment]. / Varicocèles, varices pelviennes et syndrome de congestion pelvienne : place de la radiologie interventionnelle.

Genital venous insufficiency in men is usually of constitutional origin due to valvular incontinence. Genital venous insufficiency in female is more often generated by major, lasting, and possibly repeated pregnancy-related hyperpressure phenomena. Genital venous insufficiency in men is usually expressed by visible and recognizable peritesticular varicocele. Of simple anatomic structure, it is easily accessible to endovascular treatment by embolization, which is the first-line therapy nowadays. Genital venous insufficiency in women results in a pelvic predominant varicosis, which should be evoked in case of chronic pelvic pain or atypical venous afferents to the lower limbs. Precise and guided interrogation and clinical examination allow the attending physician to be the first actor in the detection of symptomatic pelvis venous insufficiency in men and women. A chronic pelvic pain in female should evoke a pelvic congestion syndrome, symptomatic translation of pelvic varicosis, especially if it increases at the end of the day, at the effort, in pre-menstrual period. Treatment with endovascular embolization is the only therapeutic option for female pelvic venous insufficiency, of complex architecture and deep anatomical situation. The interventional radiologist offers a complete, minimally invasive and efficient treatment with limited hospital costs and perioperative constraints.

Transhepatic forceps biopsy combined with biliary drainage in obstructive jaundice: safety and accuracy.

PURPOSE: This study was conducted in order to investigate the safety and accuracy of percutaneous transluminal forceps biopsy (PTFB) during percutaneous biliary drainage (PTBD) in patients with a suspicion of malignant biliary stricture. MATERIAL AND METHODS: Fifty consecutive patients with obstructive jaundice underwent PTFB during PTBD. Biopsy specimens were obtained using 5.2-F flexible biopsy forceps and these specimens were independently analysed by two pathologists. Consensus was obtained in case of discrepancy. Biopsy was considered as a true positive when tumour cells were retrieved. In the absence of tumour cells, comparison with available surgical findings and/or endoscopic ultrasound fine-needle aspiration (EUS-FNA) and/or percutaneous liver biopsy and/or imaging or clinical follow-up was made to distinguish true and false negatives. Specificity, sensitivity, positive predictive value, negative predictive value and accuracy were calculated. Influence of tumour location and pre-operative imaging findings was evaluated. Adverse events were reported. RESULTS: Biliary drainage and tissue sampling were achieved in 100% of patients. Sensitivity and specificity were 70 and 100%, respectively, while overall accuracy was 72%. After excluding the first 25 patients, accuracy and sensitivity for tissue sampling reached 80 and 78%, respectively. Sensitivity was better (87%) if stenosis was located at the upper part of the biliary tree, compared to the lower part (55%). In case of cholangiocarcinoma or intraductal invasion suspected on imaging, biopsy was contributive in 84 and 81% of patients, respectively. Four complications occurred consisting of one bile leak, two haemobilia and one pneumoperitoneum. CONCLUSION: PTFB combined with PTBD is a safe and effective technique for both histopathological diagnosis and biliary decompression of biliary strictures. KEY POINTS: Implications for patient care: • Percutaneous transbiliary forceps biopsy is technically feasible (100% of tissue sampling in our study) and is a safe technique. • Radiological management combining PTFB plus PTBD may allow diagnosis and treatment of the biliary stricture at the same time. • Sensitivity and accuracy for PTFB reached 78 and 80%, respectively, with a 100% specificity.

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

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 (P = 0.008), the reversal of flow in the right (P = 0.038) and left (P = 0.049) portal branch, the loss of modulation of portal flow by the right atrium (P = 0.0005), ascites (P = 0.001) and the overall impression of the operator (P = 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.

Thoracic splenosis mimicking a pleuropneumonia: A case report.

RATIONALE: Splenosis is the development of one or more heterotopic splenic tissue autoimplants following rupture of the spleen and remains mostly asymptomatic. PATIENT CONCERNS: We report a case of a 50-year old post-traumatic splenectomized man admitted for a left side community acquired pneumonia resistant to antibiotics. DIAGNOSES: The diagnosis of intrathoracic ectopic spleen was suspected because of the history of spleen trauma with diaphragm rupture and the absence of Howell-Jolly bodies. INTERVENTIONS: Technetium (Tc)-m colloid scintigraphy SPECT, fused with CT scan showed an intense radionuclide uptake on hyper vascularized masses without any additional pathologic uptake and confirmed the diagnosis of thoracic splenosis. OUTCOMES: Despite any lifelong penicillin prophylaxis, he had no history of infections eight years after the diagnosis. LESSONS: Physician must be aware of this differential diagnosis and of its consequences. Depending on its size and location, it may lead to incorrect diagnosis (tumor, empyema, abscess ...), treatment and invasive procedures while the diagnosis of splenosis only relies upon imaging studies associated with functionnal study of the uptake of particles or cells.

Value of Round Ligament Artery Embolization in the Management of Postpartum Hemorrhage.

PURPOSE: To evaluate the feasibility and efficacy of embolization of the round ligament arteries in the management of postpartum hemorrhage. MATERIALS AND METHODS: Eleven women (mean age, 31 y) underwent round ligament artery because of persistent or recurrent hemorrhage after initial uterine or internal iliac artery embolization. RESULTS: A total of 16 round ligament arteries were embolized. The round ligament artery arose from the inferior epigastric artery in 11 cases (69%) and directly from the external iliac artery in 5 (31%). Embolization was performed with calibrated microspheres in 7 women (63%) and gelatin sponge pledgets in 4 (37%). Coils were used in addition to gelatin sponge pledgets in 3 patients. Hemostasis was achieved in 10 patients (91%), and 1 required additional conservative surgery. The mean hemoglobin level before embolization was 7.2 g/dL ± 1 and increased significantly on day 1 after embolization (10.3 g/dL ± 1.0; P < .05). No procedure-related complication was reported. The mean hospital stay was 5.6 days ± 2. Two patients had further pregnancies 13 and 14 months after embolization. CONCLUSIONS: Selective embolization of the round ligament artery is a safe and effective treatment for obstetric hemorrhage. It should be considered in cases of persistent or recurrent bleeding after initial uterine or internal iliac artery embolization.

A phase II study of cisplatin with intravenous and oral vinorelbine as induction chemotherapy followed by concomitant chemoradiotherapy with oral vinorelbine and cisplatin for locally advanced non-small cell lung cancer.

BACKGROUND: Concomitant platinum-based chemotherapy and radiotherapy (CT-RT) is the recommended treatment for unresectable locally advanced stage III non-small cell lung cancer (NSCLC). We conducted a phase II study to evaluate the efficacy and safety of fractionated oral vinorelbine with cisplatin as induction CT followed by CT-RT. METHODS: Patients with stage III NSCLC received 2 induction cycles of intravenous vinorelbine 25 mg/m2 and cisplatin 80 mg/m2 on day 1 and oral vinorelbine 60 mg/m2 on day 8. Responding patients received 2 more cycles of cisplatin 80 mg/m2 on day 1 and oral vinorelbine 20 mg on days 1, 3 and 5 concomitantly with radiotherapy 2 Gy daily, 5 days/week for a total of 66 Gy. RESULTS: Seventy patients, median age 61 years, were enrolled. Overall response rate (ORR) was 50.0%; Disease Control Rate was 81.42%. Median PFS was 14.58 months [95% CI, 10.97-18.75]. Median OS was 17.08 months [95% CI, 13.57-29.57]. One-year and 2-year survival rates were 68.6% [95% CI, 57.7-79.4] and 37%. One patient had a grade 3 pulmonary radiation injury and 26.5% had graded 1/2 esophagitis. CONCLUSION: In non-operable IIIA-IIIB NSCLC, the combination oral vinorelbine (fractionated fixed dose) plus cisplatin, during concomitant CT-RT, could offer a well-tolerated option, with comparable activity to I.V. vinorelbine-based chemoradiotherapy regimens. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01839032.