Leadership in Interventional Radiology - Fostering a Culture of Excellence.

This invited article reviews the current status of Interventional Radiology (IR), in terms of its status as a speciality, and outlines the conditions needed for IR to function optimally within healthcare settings. Guidance is offered in terms of developing an IR department, ensuring high-quality practice, dealing with administrative and political challenges, dealing with industry and creating a legacy.

Consensus Guidelines for the Definition of Time-to-Event End Points in Image-guided Tumor Ablation: Results of the SIO and DATECAN Initiative.

There is currently no consensus regarding preferred clinical outcome measures following image-guided tumor ablation or clear definitions of oncologic end points. This consensus document proposes standardized definitions for a broad range of oncologic outcome measures with recommendations on how to uniformly document, analyze, and report outcomes. The initiative was coordinated by the Society of Interventional Oncology in collaboration with the Definition for the Assessment of Time-to-Event End Points in Cancer Trials, or DATECAN, group. According to predefined criteria, based on experience with clinical trials, an international panel of 62 experts convened. Recommendations were developed using the validated three-step modified Delphi consensus method. Consensus was reached on when to assess outcomes per patient, per session, or per tumor; on starting and ending time and survival time definitions; and on time-to-event end points. Although no consensus was reached on the preferred classification system to report complications, quality of life, and health economics issues, the panel did agree on using the most recent version of a validated patient-reported outcome questionnaire. This article provides a framework of key opinion leader recommendations with the intent to facilitate a clear interpretation of results and standardize worldwide communication. Widespread adoption will improve reproducibility, allow for accurate comparisons, and avoid misinterpretations in the field of interventional oncology research. Published under a CC BY 4.0 license. Online supplemental material is available for this article. See also the editorial by Liddell in this issue.

Fluoroscopic-guided insertion of self-expanding metal stents for malignant gastroduodenal outlet obstruction: immediate results and clinical outcomes.

BACKGROUND: Application of self-expanding metal stents (SEMS) to treat patients suffering from malignant gastroduodenal outlet obstruction (GDOO) is today considered a well-recognized palliative treatment. Use of SEMS has emerged as an attractive alternative to surgical treatment of such patients. PURPOSE: To report the immediate and the mid-term clinical outcomes from a series of consecutive patients treated with exclusively fluoroscopic-guided insertion of SEMS. MATERIAL AND METHODS: This was a retrospective study including patients suffering from GDOO that were either ineligible for or unwilling to undergo surgery. Patients with potentially curable disease, uncorrectable coagulopathy, gastrointestinal perforation, sepsis, presence of distal small bowel obstruction, and bowel ischemia were excluded. Technical success, clinical success, and major complications were calculated. In addition, stent migration, stent re-obstruction, restenosis, and overall re-interventions due to recurrent symptoms were considered. Kaplan-Meier survival analysis was used for patient survival estimation while both bivariable and multivariable analysis were performed to identify any independent predictors of outcomes. RESULTS: Fifty-one patients, (mean age, 63.73 ± 15.62 years) met the study's criteria and were included in the final analysis. Technical and clinical success were 90.19% (n = 46/51) and 91.30% (n = 42/46), respectively. Major complications rate was 3.92%. Stent migration was noted in four cases. Restenosis and re-obstruction rates were 19.57% and 10.87%, respectively. No cases of peri-procedural mortality were noted, while Kaplan-Meier estimates for 1- and 2-year survival were 16.8% and 7.2%, respectively. Clinically successful cases and patients with primary GI tumor were related with more favorable survival compared to unsuccessful and patients suffering from GDOO due to extrinsic compression by neoplastic or lymph node disease. CONCLUSION: Exclusively fluoroscopically inserted SEMS for GDOO is safe and highly effective method for palliative treatment.

Safety Aspects and Procedural Characteristics of Ambulatory Diagnostic Cerebral Catheter Angiography.

PURPOSE: Diagnostic cerebral catheter angiography is used to assess a variety of neurovascular pathologies especially in patients before and after endovascular neurointerventional treatment. In many centers diagnostic cerebral angiographies are performed with the patient staying for one night in the hospital because there are not yet sufficient data on the safety of ambulatory cerebral angiography. At the same time hospitals face a growing demand to perform ambulatory medical procedures. METHODS: A total of 426 ambulatory diagnostic cerebral angiographies were retrospectively analyzed. Technical details of the angiographies were analyzed to identify procedural risk factors. RESULTS: Out of 426 patients 14 (3.3%) had some form of complication, 3 developed minor transient neurological symptoms, 1 patient developed Quincke's edema probably as an adverse reaction to contrast agent, 1 patient had an asymptomatic carotid dissection and 1 had a fall of unknown etiology. Of the 14 complications 8 were puncture site complications with 1 re-bleeding, 1 dissection, and 6 minor complications, 421 punctures were femoral, 3 radial and 2 brachial. Out of 333 patients with magnetic resonance imaging (MRI) after angiography 21 showed focal diffusion-weighted imaging (DWI) lesions but none of these lesions were symptomatic. The rate of DWI lesions was significantly higher in selectively angiography territories than in other territories. The use of a Simmons 2 catheter significantly increased the rate of DWI lesions (p = 0.047), whereas 3D rotational angiography did not (p = 0.55). The rate of DWI lesions per selectively accessed vessel was 4.6% with a higher rate in the anterior than in the posterior circulation. CONCLUSION: Diagnostic cerebral catheter angiography can be safely performed in an ambulatory setting.

Fluoroscopically guided dilation of esophageal strictures in patients with dystrophic epidermolysis bullosa: long-term results.

OBJECTIVE: The purpose of this study was to investigate the immediate and long-term outcomes after fluoroscopically guided balloon dilation of esophageal strictures in a series of patients with dystrophic epidermolysis bullosa (DEB). MATERIALS AND METHODS: Between 2005 and 2011, the medical records of all patients with DEB treated with fluoroscopically guided balloon dilation of esophageal strictures were included in the study and retrospectively analyzed. The indication for treatment was dysphagia attributed to at least one radiologically verified esophageal stricture. The primary endpoints of the study included procedural technical success, clinical improvement assessed with a 0-4 dysphagia score, and major complication rate. Secondary endpoints were patient survival and reintervention rates. RESULTS: Nineteen consecutively registered patients with DEB (age range, 10-51 years; mean, 30 ± 12.2 years) and dysphagia due to esophageal strictures were treated with fluoroscopically guided balloon dilation. In total, 90 procedures and 121 dilations were performed to manage 28 lesions. Balloon diameter ranged from 8 to 18 mm. The mean follow-up time was 47.51 ± 16.64 months (range, 17-73 months). The technical success rate was 96.7% (87/90). There were no major complications. The mean reintervention rate was 1.19 dilations per patient per year, and the postprocedural dysphagia score (0.72 [95% CI, 0.56-0.87]) was significantly lower than baseline (2.50 [95% CI 2.35-2.65]) (p < 0.001). CONCLUSION: Repeated fluoroscopically guided balloon dilation is safe and effective for the management of dysphagia caused by esophageal strictures in DEB. Use of this technique was associated with marked clinical improvement in dysphagia and satisfactory long-term reintervention rates with no major complications.

Successful exclusion of a large bronchopleural fistula using an Amplatzer II vascular plug and glue embolization.

We report a case of a 63-year-old man with a complicated postsurgical bronchopleural fistula (BPF), which was treated with a minimally-invasive hybrid procedure using fluoroscopy, bronchoscopy, and thoracoscopy. A previous surgical attempt had failed to seal the pathologic tract. An Amplazter II vascular plug was successfully deployed into the BPF, followed by autologous blood and glue injection. An adjunctive endoscopically-guided glue embolization was deemed necessary. The 14-month clinical and imaging follow-up confirmed the successful exclusion of the BPF. No migration of the device was noted and the patient remained asymptomatic. The combined endoscopic and fluoroscopic guided management of a BPF using the Amplatzer II vascular plug and glue was proven safe and effective after mid-term follow-up.

Percutaneous cementoplasty.

Cementoplasty includes percutaneous procedures like vertebroplasty, kyphoplasty, osteoplasty, and sacroplasty. Bone packing with cement aims to treat or prevent vertebral and extraspinal pathological fractures and relieve pain in patients with osteoporosis and bone metastases. The authors outline the accepted and newer indications for patient selection and present the fundamentals of image-guided lesion access and cement injection. Practitioners should evaluate each patient carefully and have a thorough knowledge of the anatomy, the technique, the expected outcomes, and the potential complications. Detailed informed consent and multidisciplinary decision making are recommended. Understanding of the particular advantages and limitations of the various modern filler materials is also crucial for a successful and uncomplicated procedure. Future developments include new mechanical devices for effective restoration of vertebral height, as well as the introduction of osteoconductive and osteoinductive cements that will be able to promote more physiological bone healing.

Direct erosion and prolapse of esophageal stents into the tracheobronchial tree leading to life-threatening airway compromise.

Covered or uncovered self-expanding metal stents are currently used for the palliative treatment of neoplastic esophageal obstructions or compressions and malignant esophageal leaks or fistulas. This small series, from three different European hospitals, highlights the unusual but significant complication of esophageal stent perforation followed by erosion and prolapse of the endoprosthesis into the tracheobronchial tree causing acute airway compromise or aspiration. Possible causal mechanisms and means of treatment are discussed to raise physician awareness of this life-threatening complication.

Peripheral endografts for the treatment of traumatic arterial injuries.

Catheter-based endovascular techniques for vascular trauma management are being increasingly reported. Covered stents may be inserted and deployed through a remote site of percutaneous access under local anesthesia and are ideal for treating arterial ruptures and pseudoaneurysms and to seal off arteriovenous communications. Advantages of endovascular stent-graft repair of peripheral traumatic arterial injuries include less blood loss and tissue damage, reduced operative time and morbidity, shortened hospital stay and recovery periods, and reduced healthcare costs. The present report provides an overview of the role of balloon-expandable and self-expandable covered stents in the minimally invasive treatment of various types of traumatic arterial injuries.

Randomised comparison of the FerX Ella antireflux stent and the ultraflex stent: proton pump inhibitor combination for prevention of post-stent reflux in patients with esophageal carcinoma involving the esophago-gastric junction.

BACKGROUND AND AIM: Metal stents placed across the gastroesophageal junction in patients with malignant dysphagia frequently present with reflux symptoms. We compared an antireflux stent with a standard open stent used in combination with proton pump inhibitor medication. METHODS: Forty-nine patients with dysphagia due to inoperable carcinoma in the lower third of the esophagus were randomly selected to receive either a antireflux valve stent (FerX-Ella) (n = 22) or a covered standard open stent (Ultraflex), which was combined with proton pump inhibitors such as omeprazole (n = 26). The technical success, the presence of reflux, and complications were recorded. RESULTS: Reflux was seen in 3/22 patients (13.6%) in the FerX-Ella group and in 2/26 patients (7.7%) in the Ultraflex and proton pump inhibitor combination group (P-value not significant). In both groups, a significant improvement in the dysphagia score was seen and no statistically significant difference was detected between the two groups (P = 0.84). The FerX-Ella stents migrated more frequently (32%) than the Ultraflex stents (23%). This also necessitated surgical intervention more frequently in the FerX-Ella group (2/22, 9.1%) compared to the Ultraflex group (1/26, 3.8%). CONCLUSION: The antireflux stent had no demonstrable advantages compared to the combination of standard open stent and proton pump inhibitor medication.

Transcatheter Arterial Embolization for Bleeding Peptic Ulcers: A Multicenter Study.

PURPOSE: To investigate the outcomes of transcatheter arterial embolization (TAE) for the treatment of peptic ulcer bleeding (PUB). MATERIALS AND METHODS: This is a retrospective, multicenter study, which investigated all patients who underwent TAE for the treatment of severe upper gastrointestinal hemorrhage from peptic ulcers in five European centers, between January 1, 2012 and May 1, 2017. All patients had undergone failed endoscopic hemostasis. Forty-four patients (male; mean age 74.0 ± 11.1 years, range 49-94), with bleeding from duodenum (36/44; 81.8%) or gastric ulcer (8/44; 18.2%) were followed up to 3.5 years (range 2-1354 days). In 42/44 cases, bleeding was confirmed by pre-procedural CT angiography. In 50% of the cases, coils were deployed, while in the remaining glue, microparticles, gel foam and combinations of the above were used. The study's outcome measures were 30-day survival technical success (occlusion of feeding vessel and/or no extravasation at completion DSA), overall survival, bleeding relapse and complication rates. RESULTS: The technical success was 100%. The 30-day survival rate was 79.5% (35/44 cases). No patients died due to ongoing or recurrent hemorrhage. Re-bleeding occurred in 2/44 cases (4.5%) and was successfully managed with repeat TAE (one) or surgery (one). The rate of major complications was 4.5% (2/44; one acute pancreatitis and one partial pancreatic ischemia), successfully managed conservatively. According to Kaplan-Meier analysis survival was 71.9% at 3.5 years. CONCLUSIONS: TAE for the treatment of PUB was technically successful in all cases and resulted in high clinical success rate. Minimal re-bleeding rates further highlight the utility of TAE as the second line treatment of choice, after failed endoscopy.

Relative threshold of detection of active arterial bleeding: in vitro comparison of MDCT and digital subtraction angiography.

OBJECTIVE: The objective of our study was to determine the relative sensitivity and the lowest threshold of bleeding detectable with digital subtraction angiography (DSA) and with MDCT using an in vitro physiologic system. MATERIALS AND METHODS: A closed pulsatile cardiopulmonary bypass circuit was connected to tubes traversing a water bath to simulate the abdominal aorta and inferior vena cava. Three smaller interconnecting acrylic plastic tubes were connected as branches to the aortic tubing to simulate branch vessels. One of the three tubes, the control, had no holes in it, one had a 100-microm hole, and one had a 280-microm hole. The leakage rates were predetermined with a cardiac output of 2 and 4 L/min and with a mean arterial pressure (MAP) ranging from 30 to 100 mm Hg for each hole size. The following studies were performed for each of the predetermined leakage rates. For study 1, 16-MDCT was performed using bolus tracking after 35 mL of contrast medium had been injected into a simulated peripheral vein. For study 2, DSA was performed using a 4-French straight catheter placed 10 cm proximal to the holes (selective first aortic branch cannulation). For study 3, DSA was performed with a catheter placed in the small branch at the site of the hole (highly superselective). For study 4, 16-MDCT was performed with a catheter placed as in study 2, 10 cm proximal to the holes, for the detection of lower leakage rates. Cine loops of MDCT and DSA images were examined by two blinded observers to detect extravasation from the holes in the tubes (i.e., the branch arteries). Interobserver agreement was studied using Cohen's kappa statistic. RESULTS: The threshold to detect bleeding was as follows for each study: For IV contrast-enhanced MDCT (study 1), it was 0.35 mL/min; DSA with a catheter 10 cm proximal to the holes (study 2), 0.96 mL/min; DSA with a catheter at the holes (study 3), 0.05 mL/min [corrected] or lower; and intraarterial selective MDCT (study 4), 0.05 mL/min [corrected] or lower. The ease of detection improved with increasing MAPs and larger volumes of leakage. Interobserver correlation was excellent. CONCLUSION: In vitro, i.v. contrast-enhanced MDCT is more sensitive than first-order aortic branch-selective DSA in detecting active hemorrhage unless the catheter position is highly superselective and is close to the bleeding artery. These results suggest that MDCT can be used as the initial imaging technique in the diagnosis of active hemorrhage if the clinical condition of the patient allows.

Alleviation of severe compressive symptoms in a patient with advanced lung carcinoma using tracheal and superior vena cava stents.

Lung cancer is now the leading cause of death from cancer worldwide. Although surgery remains the treatment of choice, the majority of patients will be unresectable at presentation with a poor survival outcome. In those patients who also have tracheobronchial involvement; the aim of intervention is to restore airway patency, thus improving quality of life in a minimally invasive way. Superior vena cava (SVC) infiltration by lung carcinoma is present in 3%-5% of patients with lung cancer. In patients with malignant SVC syndrome, the average life expectancy is 3 to 10 months. In these cases the disease progresses rapidly and obstruction develops before there is time for collaterals to develop. We present a case of a 75-year-old man who had alleviation of severe compressive symptoms secondary to advanced lung carcinoma using tracheal and SVC stents placed as a single procedure.

Interventional radiology in breast cancer.

Molecular profiling of metastatic disease may greatly influence the systemic therapy recommended by oncologists and chosen by patients, allowing treatment to be more targeted. Comprehensive care of patients with advanced breast cancer now includes percutaneous image-guided biopsy if this has the potential to influence systemic treatment [1]. Interventional radiologists can contribute significantly to the care of patients affected by breast cancer, in diagnostic and supportive procedures and importantly also in treatment. Interventional radiologists carry out image guided percutaneous biopsies not only of the primary tumour but also of metastases. They insert percutaneous ports and tunnelled central venous catheters. They ablate painful bone metastases, and can treat or prevent pathological fractures. Most importantly they can ablate liver metastases in patients with limited or oligometastatic disease. The inhomogeneity and variety of cell populations in metastatic tumours from breast cancer, which is an important consideration in systemic therapy, is not an important consideration in the treatment of metastatic tumours using percutaneous ablative techniques, which are the major focus of this article. The treatment of primary tumours in the breast is also being explored, but is considered in its infancy at this stage.

Image-guided therapies in orthopedic oncology.

The treatment of patients who have malignancies of bone often require multidisciplinary care. The aim of this review is to outline percutaneous techniques that may be useful for the diagnosis and treatment of these patients. In particular, the existing procedures of percutaneous biopsy, alcoholization (ethanol ablation), vertebroplasty, kyphoplasty, osteoplasty, radiofrequency ablation, laser photocoagulation, and vascular embolization are reviewed. Aspects of each technique, including mechanism of action, patient selection, treatment technique, and recent patient outcome are presented.