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.

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.

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.

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.

Percutaneous Radiofrequency Ablation Versus Robotic-Assisted Partial Nephrectomy for the Treatment of Small Renal Cell Carcinoma.

INTRODUCTION: The authors compared the oncologic outcomes of radiofrequency ablation (RFA) with robotic-assisted partial nephrectomy (RPN) for the treatment of T1 stage renal cell carcinoma (RCC). MATERIALS AND METHODS: This was a retrospective data analysis of a high-volume single tertiary centre. Patients were treated with RFA or RPN following multidisciplinary decision making. Only histologically proven RCCs were included. Baseline demographics were collected, and PADUA scores of tumour features were calculated to standardize baseline anatomy. Peri-operative complications, kidney function and oncological outcomes were compared. RESULTS: Sixty-three cases were included in each group. Baseline renal function was poorer in RFA, and 16/63 RFA patients had tumours in single kidneys compared to 1/63 RPN cases (p < 0.001). Length of stay was shorter in RFA (1 vs. 3 days, p < 0.0001). Post-procedure renal function decline at 30 days was significantly less in RFA [(-0.8) ± 9.6 vs. (-16.1) ± 19.5 mls/min/1.73 m2; p < 0.0001]. More minor complications were recorded in RPN (10/63 vs. 4/63, p = 0.15), but local recurrence was numerically higher in RFA (6/63 vs. 1/63, p = 0.11). Disease-free survival (DFS) was not significantly different (adjusted HR = 0.6, 95 % Cl 0.1-3.7; p = 0.60). Increasing tumour size was an independent predictor of local recurrence (adjusted HR = 1.7; 95 % Cl 1.1-2.6 per cm; p = 0.02). CONCLUSIONS: Both RPN and RFA offer very good oncological outcomes for the treatment of T1 RCC with low peri-operative morbidity and similar oncologic outcomes. RFA demonstrated fewer peri-operative complications and better preservation of renal function, whereas RPN had an insignificantly lower local recurrence rate. RFA should be offered alongside RPN for selected cases.

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.

Interventional oncology in multidisciplinary cancer treatment in the 21(st) century.

Interventional oncology is an evolving branch of interventional radiology, which relies on rapidly evolving, highly sophisticated treatment tools and precise imaging guidance to target and destroy malignant tumours. The development of this field has important potential benefits for patients and the health-care system, but as a new discipline, interventional oncology has not yet fully established its place in the wider field of oncology; its application does not have a comprehensive evidence base, or a clinical or quality-assurance framework within which to operate. In this regard, radiation oncology, a cornerstone of modern cancer care, has a lot of important information to offer to interventional oncologists. A strong collaboration between radiation oncology and interventional oncology, both of which aim to cure or control tumours or to relieve symptoms with as little collateral damage to normal tissue as possible, will have substantial advantages for both disciplines. A close relationship with radiation oncology will help facilitate the development of a robust quality-assurance framework and accumulation of evidence to support the integration of interventional oncology into multidisciplinary care. Furthermore, collaboration between interventional oncology and radiation oncology fields will have great benefits to practitioners, people affected by cancer, and to the wider field of oncology.

Palliation of esophageal cancer with a double-layered covered nitinol stent: long-term outcomes and predictors of stent migration and patient survival.

PURPOSE: To evaluate the long-term clinical outcomes and the negative predictors after the deployment of double-layered stents in malignant esophageal strictures. METHODS: This is a single-center study of patients who received a double-layered covered stent for the palliation of dysphagia due to malignant esophageal strictures in a 3-year period. 56 patients fulfilled the inclusion criteria. The study's primary end points were technical success, dysphagia improvement, stent migration, and complication rates; secondary end points were the stent's primary patency and overall survival. Cox regression analysis was used to adjust for confounding variables and to identify predictors of survival outcomes. RESULTS: Technical success was 95%. Median dysphagia score improved significantly after stenting (p < 0.0001). Stent migration rate was 7.1% and occurred exclusively in the group of patients who received chemoradiotherapy (p < 0.01). The median stent patency was 87 days (range 5-444 days). Dysphagia reoccurred in 39.3% and was successfully managed with restenting in 98.2%. The median survival was 127 days (range 15-1480 days). Chemoradiotherapy and baseline histology did not influence survival outcomes. Survival was adversely affected by metastases (p = 0.005) and poor oral intake (p = 0.048). Patient survival was improved by repeat stenting in case of tissue overgrowth (p = 0.06). CONCLUSION: The device is safe and effective for the treatment of patients with dysphagia due to esophageal cancer. Migration rate is zero for patients who do not receive chemoradiotherapy. Reintervention when required is a positive survival predictor.

Tracheobronchial stenting for malignant airway disease: long-term outcomes from a single-center study.

The aim of this retrospective study is to investigate the immediate and long-term outcomes following the insertion of covered and uncovered self-expandable metallic stent (SEMS) for the management of malignant tracheobronchial disease. A total of 49 patients (27 male, mean age 60.9 ± 15 years) underwent 77 SEMS insertions (57 uncovered). The procedure was performed in theater using combined bronchoscopic and fluoroscopic guidance. The study's primary end points included technical success (97.9%), clinical success (91.8%), and symptom recurrence (14.2%). The mean follow-up time was 5.5 ± 5.9 months. We concluded that tracheobronchial SEMSs provide safe and effective minimally invasive long-term management of patients with symptomatic malignant airway disease.

The use of biodegradable stents in malignant oesophageal strictures for the treatment of dysphagia before neoadjuvant treatment or radical radiotherapy: a feasibility study.

PURPOSE: To evaluate the clinical results of the use of biodegradable oesophageal stents in malignant strictures. METHODS: Eleven patients were included in this prospective analysis in which a woven polydioxanone biodegradable oesophageal stent was used. The inclusion criterion was that the patient underwent neoadjuvant treatment or radical radiotherapy after the stent insertion. Primary end points were dysphagia score at discharge, stent patency, and complication rate. Secondary end points were overall survival and surgical outcome of surgery. RESULTS: There was a 100% procedure technical success rate. Early complications occurred in three patients resulting in failure to restore oral nutrition. In the remaining eight patients, dysphagia was significantly improved at discharge. Mean stent patency rate in this group was 71.5 days. Stent dysfunction occurred in five of eight patients (62.5%); in two of five patients this was due to local inflammatory reaction, and in three of five patients it was due to tumour growth after a mean time of 97.8 days, and a new metallic stent was consequently placed in four of five patients. One patient was successfully treated with esophagectomy. At the end of follow-up (mean time 102.1 days), three of eight stents were patent. The overall patient survival rate was 81.8%. CONCLUSION: Although short-term dysphagia scores improved, biodegradable stents do not appear to offer a clear beneficial effect in most cases of malignant strictures, particularly due to a local inflammatory reaction that may be induced. Technical improvement of the device and delineation of the patient group that would benefit from its use is necessary if further studies are to be conducted in the future.

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.

Endovascular treatment of visceral aneurysms and pseudoaneurysms: long-term outcomes from a multicenter European study.

PURPOSE: To investigate the percutaneous endovascular management of visceral aneurysms (VA) and visceral pseudoaneurysms (VPA) treated in three European interventional radiology departments. METHODS: Patient archives from the department's databases were examined and retrospectively analyzed. Patients diagnosed between 2000 and 2010 with VA and/or VPA, confirmed by computed tomography angiography, magnetic resonance angiography, or digital subtraction angiography and treated exclusively with percutaneous endovascular methods, were included in the study. The study's primary end points were procedural technical success, target lesion reintervention rate, and periprocedural mortality rate. Secondary end points included major and minor complications rates. RESULTS: The medical records of 54 patients (41 male, mean age 55 ± 18.1 years) with 58 VAs or VPAs and treated with various percutaneous endovascular therapeutic modalities were analyzed. In total, 21 VAs (mean diameter 49.4 ± 21 mm, range 20-100 mm) and 37 VPAs (mean diameter 25.1 ± 14.6 mm, range 8-60 mm) were treated. Procedural technical success was achieved in 100% of the cases, while target lesion reintervention rate was 6.1% (2 of 33) and 14.2% (3 of 21) in the VPA and VA groups, respectively. Mean clinical follow-up period was 19.1 ± 21.4 months. Overall periprocedural mortality rate was 3% (1 of 33) in the VPA group and 0% (0 of 21) in the VA group. CONCLUSION: Percutaneous endovascular treatment of VAs and VPAs is safe and effective with low morbidity and mortality. There is a small but significant reintervention rate, particularly for true aneurysms; dedicated follow-up imaging is recommended. Successful aneurysm exclusion was achieved in all cases with a second procedure.