Fostering research in pediatric interventional radiology: needs assessment and suggestions for support.

BACKGROUND: Due to the rarity of pediatric diseases, collaborative research is the key to maximizing the impact of research studies. A research needs assessment survey was created to support initiatives to foster pediatric interventional radiology research. OBJECTIVE: To assess the status of pediatric interventional radiology research, identify perceived barriers, obtain community input on areas of research/education/support, and create metrics for evaluating changes/responses to programmatic initiatives. MATERIALS AND METHODS: A survey link was sent to approximately 275 members of the Society for Pediatric Interventional Radiology (SPIR) between May and October 2020. Data was collected using a web-based interface. Data collected included practice setting, clinical role, research experience, research barriers, and suggestions for future initiatives. RESULTS: Fifty-nine surveys were analyzed with a staff physician survey response rate of 28% (56/198). A wide range of practice sizes from 15 countries were represented. Respondents were predominantly staff physicians (95%; 56/59) with an average of 11 years (range: 1-25 years) of clinical experience working at academic or freestanding children's hospitals. A total of 100% (59/59) had research experience, and 70% (41/58) had published research with a mean of 30 peer-reviewed publications (range: 1-200). For job security, 56% (33/59) of respondents were expected or required to publish, but only 19% (11/58) had research support staff, and 42% (25/59) had protected research time, but of those, 36% (9/25) got the time "sometimes or never." Lack of support staff, established collaborative processes, and education were identified as top barriers to performing research. CONCLUSIONS: The needs assessment survey demonstrated active research output despite several identified barriers. There is a widespread interest within the pediatric interventional radiology community for collaborative research.

Findings in percutaneous trans-hepatic cholecysto-cholangiography in neonates and infants presenting with conjugated hyperbilirubinemia: emphasis on differential diagnosis and cholangiographic patterns.

BACKGROUND: Biliary atresia (BA) is one of the causes of conjugated hyperbilirubinemia in infants which if untreated leads to end-stage liver disease and death. Percutaneous Trans-hepatic Cholecysto-Cholangiography (PTCC) is a minimally invasive study which can be utilized in the diagnostic work-up of these patients. This study's purpose is to describe the experience with PTCC in neonates, the imaging findings encountered, and the abnormal patterns which warrant further investigation. METHODS: A 16-year single-center retrospective study of patients with persistent neonatal cholestasis (suspected BA) undergoing PTCC. Patient demographics, laboratory values, PTCC images, pathology and surgical reports were reviewed. RESULTS: 73 patients underwent PTCC (68% male, mean age 8.7 weeks, mean weight 4.0 Kg). The majority of studies were normal (55%). Abnormal patterns were identified in 33 cases, 79% were diagnosed with BA and 12% with Alagille syndrome. Non-opacification of the common hepatic duct with a narrowed common bile duct (42%) and isolated small gallbladder (38%) were the most common patterns in BA. CONCLUSION: PTCC is a minimally invasive study in the diagnostic work-up of infants presenting with conjugated hyperbilirubinemia (suspected BA). Further invasive investigations or surgery can be avoided when results are normal.

Local reference and achievable dose levels for vascular and enterostomy access procedures in pediatric interventional radiology.

BACKGROUND: Knowledge of radiation quantities delivered in routine practice is an essential responsibility of a pediatric interventional radiology department. OBJECTIVE: To review radiation indices in frequently performed vascular and enterostomy access procedures at a quaternary pediatric hospital to formulate dosimetric reference levels and achievable levels. MATERIALS AND METHODS: A retrospective review of patient demographics, procedure information and quantitative dose metrics over a 2-year period was performed. Dosimetric details for common procedures (central line insertions, gastrostomy/gastrojejunostomy insertions and maintenance) were evaluated, correlated with demographic data and stratified across five weight groups (0-5 kg, 5-15 kg, 15-30 kg, 30-50 kg, 50-80 kg). Achievable (50th percentile) and reference (75th percentile) levels with confidence intervals were established for each procedure. RESULTS: Within the evaluation period, 3,165 studies satisfied the inclusion criteria. Five were classified as device insertions (peripherally inserted central catheter, n=1,145; port-a-catheter, n=321; central venous line, n=285; gastrostomy-tube [G-tube], n=262, and gastrojejunostomy-tube [GJ-tube], n=66), and two were classified as maintenance procedures (G-tube, n=358, and GJ-tube, n=728, checks, exchanges and reinsertions). Representative reference and achievable levels were calculated for each procedure category and weight group. CONCLUSION: This work highlights the creation of local reference and achievable levels for common pediatric interventional procedures. These data establish a dosimetric reference to understand the quantity of radiation routinely applied, allowing for improved relative radiation risk assessment and enriched communication to interventionalists, health care providers, parents and patients.

Turning down the heat: The case for mild hyperthermia and thermosensitive liposomes.

"A single disappointing study does not mean an end to the future of ThermoDox®", writes Michael Tardugno (CEO of Celsion Corporation), after announcing the termination of Celsion's second Phase III clinical trial. The OPTIMA trial, as it was known, evaluated their thermosensitive liposome (TSL) formulation of doxorubicin (ThermoDox®) in combination with radiofrequency ablation for the treatment of hepatocellular carcinoma (HCC). The purpose of this perspective is to review the case of ThermoDox and to address questions related to its clinical translation. Specifically, what has prevented the clinical translation of this once highly regarded breakthrough technology? Is this the end of TSLs? What can we learn from the challenges faced in the clinical development of this multi-modal therapy? As formulation scientists working in the field, we continue to believe that heat-triggered drug delivery platforms have tremendous potential as chemotherapy. Herein, we highlight potential limitations in the design of many of the Thermodox clinical trials, and we propose that despite these setbacks, TSLs have the potential to become an effective component of cancer therapy.

Image-guided chest tube drainage in the management of chylothorax post cardiac surgery in children: a single-center case series.

BACKGROUND: In children, chylothorax post cardiac surgery can be difficult to treat, may run a protracted course, and remains a source of morbidity and mortality. OBJECTIVE: To analyze the experience with percutaneous image-guided chest-tube drainage in the management of post-cardiac-surgery chylothoraces in children. MATERIALS AND METHODS: We conducted a single-center retrospective case series of 37 post-cardiac-surgery chylothoraces in 34 children (20 boys; 59%), requiring 48 drainage procedures with placement of 53 image-guided chest tubes over the time period 2004 to 2015. We analyzed clinical and procedural details, adverse events and outcomes. Median age was 0.6 years, median weight 7.2 kg. RESULTS: Attempted treatments of chylothoraces prior to image-guided chest tubes included dietary restrictions (32/37, 86%), octreotide (12/37, 32%), steroids (7/37, 19%) and thoracic duct ligation (5/37, 14%). Image-guided chest tubes (n=43/53, 81%) were single unilateral in 29 children, bilateral in 4 (n=8/53, 15%), and there were two ipsilateral tubes in one (2/53, 4%). Effusions were isolated, walled-off, in 33/53 (62%). In 20/48 procedures (42%) effusions were septated/complex. The mean drainage through image-guided chest tubes was 17.3 mL/kg in the first 24 h, and 13.4 mL/kg/day from diagnosis to chest tube removal; total mean drainage from all chest tubes was 19.6 mL/kg/day. Nine major and 27 minor maintenance procedures were required during 1,207 tube-days (rate: 30 maintenance/1,000 tube-days). Median tube dwell time was 21 days (range 4-57 days). There were eight mild adverse events, three moderate adverse events and no severe adverse events related to image-guided chest tubes. Radiologic resolution was achieved in 26/37 (70%). Twenty-three children (68%) survived to discharge; 11 children (32%) died from underlying cardiac disease. CONCLUSION: Management of chylothorax post-cardiac-surgery in children is multidisciplinary, requiring concomitant multipronged approaches, often through a protracted course. Multiple image-guided chest tube drainages can help achieve resolution with few complications. Interventional radiology involvement in tube care and maintenance is required. Overall, mortality remains high.

Use of Tissue Plasminogen Activator in Abdominal Abscesses in Children-A Single-Center Randomized Control Trial.

PURPOSE: To establish the efficacy of once-per-day intracavitary tissue plasminogen activator (tPA) in the treatment of pediatric intra-abdominal abscesses. METHODS: A single-center prospective, double-blinded, randomized controlled trial of the use of intracavitary tPA in abdominal abscesses in children. Patients were randomized to either tPA-treatment or saline-treatment groups. Primary outcome was drainage catheter dwell (hours). Secondary outcomes were length of hospital stay, times to discharge, clinical and sonographic resolution, and adverse events (AEs). RESULTS: Twenty-eight children were randomized to either group (n = 14 each). Demographics between groups were not significantly different (age P = .28; weight P = .40; gender P = .44). There were significantly more abscesses in the tPA-treated group (P = .03). Abscesses were secondary to perforated appendicitis (n = 25) or postappendectomy (n = 3). Thirty-four abscesses were drained, 4 aspirated, 3 neither drained/aspirated. There was no significant difference in number of drains (P = .14), drain size (P = .19), primary outcome (P = .077), or secondary outcomes found. No procedural or intervention drug-related AEs occurred. No patient in the saline-treated group required to be switched/treated with tPA. CONCLUSION: No significant difference in the length of catheter dwell time, procedure time to discharge, or time to resolution was found. Intracavitary tPA was not associated with morbidity or mortality. The results neither support nor negate routine use of tPA in the drainage of intra-abdominal abscess in children. It is possible that a multicentre study with a larger number of patients may answer this question more definitively.

Evaluation of implanted venous port-a-caths in children with medical complexity and neurologic impairment.

BACKGROUND: Children with medical complexity and associated neurologic impairment frequently face difficulties with venous access. Intermittently they require urgent intravenous administration of fluids and medication. OBJECTIVE: To analyze the use of implanted port-a-caths in children with medical complexity who have neurologic impairment and difficult venous access. MATERIALS AND METHODS: We performed a single-center observational study of port-a-caths placed by interventional radiologists in children with medical complexity with neurologic impairment. We analyzed peripheral intravenous access attempts, peripheral intravenous starts, peripheral intravenous complications, alternative temporary central venous access devices, port-a-cath insertions, catheter days, access days, port-a-cath-related complications, hospital admissions and emergency department visits. We compared the year pre port-a-cath to the year post port-a-cath. RESULTS: Twenty-one children with medical complexity with neurologic impairment (10 boys, 11 girls; median age 4.1 years; median weight 13.7 kg) underwent 26 port-a-cath insertions (median catheter days 787). In the year post port-a-cath compared to pre port-a-cath there was a highly significant reduction (P<0.001) in numbers of peripheral intravenous attempts, peripheral intravenous starts and skin punctures; and a significant reduction (P<0.05) in need for other devices, number of emergency department visits, emergency department visits resulting in hospital admissions, and total admissions. Adverse events were graded as mild (n=18), moderate (n=6) and severe (n=0). CONCLUSION: Port-a-cath placement in children with medical complexity with neurologic impairment significantly reduced all peripheral intravenous attempts, peripheral intravenous starts, skin punctures, total number of emergency department visits, visits culminating in admission, and total number of inpatient admissions. Advantages must be considered against potential port-a-cath-related adverse events.

Use of the Transrectal Ultrasound Probe in Aspiration and Drainage in Pediatric Patients: A Retrospective Observational Study.

PURPOSE: To retrospectively evaluate the safety and efficacy of transrectal ultrasound (TRUS) probe use for aspiration and drainage of pelvic abscesses in children. MATERIALS AND METHODS: Patient demographics, procedural details, technical success, safety, and clinical course of TRUS procedures were retrospectively analyzed. Between 2007 and 2016, 118 TRUS-guided procedures were performed in 115 children (60 males, 55 females); median age was 12.4 years (range, 2.4-17.9 years) and median weight was 45 kg (range, 12.6-112 kg). Ten children were 5 years of age or younger. RESULTS: In total, 113/118 procedures were performed under general anesthesia. The rectum accommodated the probe and needle guide without resistance in all children (technical feasibility, 100%). Abscesses were anterior to the rectum in 116/118 and posterior in 2/118. One hundred twelve collections were drained, 4 were aspirated, and 2 procedures were aborted, both subsequently successfully drained (2 and 3 days later). One patient underwent repeat drainage after 28 months. No major complications were reported. Median times to temperature normalization was 0 days (mean, 1.2; range, 0-13 days), catheter dwell time 5 days (mean, 6; range, 2-21 days), drain removal to discharge 1 day (mean, 2; range, 0-41 days), and follow-up 117 days (mean, 195; range, 5-2,690 days). CONCLUSIONS: TRUS-guided drainage using the TRUS probe and needle guide is a safe and effective method for aspiration and drainage of pelvic abscesses in children as young as 2 years.

Perforations associated with peripherally inserted central catheters in a neonatal population.

BACKGROUND: Peripherally inserted central catheters (PICCs) are increasingly used in neonates but perforations can result in devastating complications such as pericardial and pleural effusions. Identifying risk factors may guide surveillance and reduce morbidity and mortality. OBJECTIVE: To determine the risk factors for PICC perforation in neonates. MATERIALS AND METHODS: Retrospective case:control (1:2) study of neonates admitted between 2004-2014. Charts and imaging were reviewed for clinical and therapeutic risk factors. RESULTS: Among 3,454 PICCs, 15 cases of perforation (incidence 0.4%, 5 pericardial effusions, 10 pleural effusions) were matched to 30 controls, based on gestation and insertion date. Timing of perforations post-insertion was median 4 days for pericardial effusions and 21.5 days for pleural effusions. A risk factor for pericardial effusion was lower weight at PICC insertion compared with controls. There were no statistically significant differences between cases and controls in catheter material, insertion site, PICC size and lumen number. Among upper limb PICCs, pericardial effusions were associated with tip positions more proximal to the heart at insertion (P=0.005) and at perforation (P=0.008), compared with controls. Pleural effusions were associated with tip positions more distal from the heart at perforation (P=0.008). Within 48 h before perforation, high/medium risk infusions included total parenteral nutrition (100% cases vs. 56.7% controls, P=0.002) and vancomycin (60% cases vs. 23.3% controls, P=0.02). CONCLUSION: PICC-associated pericardial effusions and pleural effusions are rare but inherent risks and can occur at any time after insertion. Risk factors and etiologies are multifactorial, but PICC tip position may be a modifiable risk factor. To mitigate this risk, we have developed and disseminated guidelines for target PICC positions and routinely do radiographs to monitor PICCs for migration and malposition in our NICU. The increased knowledge of risk profiles from this study has helped focus surveillance efforts and facilitate early recognition and treatment.

Technique, Safety, and Yield of Bone Biopsies for Histomorphometry in Children.

PURPOSE: To evaluate image-guided bone biopsy for bone histomorphometry to assess osteoporosis in children with respect to safety and yield. MATERIALS AND METHODS: A single-center retrospective review was performed of 79 bone biopsies in 73 patients performed between 2007 and 2015. Biopsies of the iliac bone were performed under general anesthesia, after tetracycline labeling, using a Rochester needle (Medical Innovations International, Inc, Rochester, Minnesota). Ultrasound and fluoroscopic guidance were used in all procedures. Biopsy technique, technical success, safety, and histomorphometry results (complete, incomplete, none) were analyzed. RESULTS: There were 41 male patients (51.8%). Technical success was achieved in 76/79 (96%) procedures. Of 79 biopsies, 75 (95%) were uneventful. Unplanned overnight observation was required in 3 (minor SIR grade B), and prolonged hospital stay owing to hematoma causing nerve compression pain was required in 1 (major SIR grade D). Complete histomorphometric reports were obtained in 69 (87%) procedures, incomplete reports were obtained in 7 (9%), and no reports were obtained in 3(4%). Incomplete reports were insufficient to provide a definitive diagnosis or guide treatment. Histomorphometry impacted subsequent therapy in 69 (87%) biopsies. CONCLUSIONS: Image-guided bone biopsy for osteoporosis using the Rochester needle is a valuable and safe technique for establishing the diagnosis of osteoporosis and directing treatment based on histomorphometry results.

Establishing a clinical service for the treatment of osteoid osteoma using magnetic resonance-guided focused ultrasound: overview and guidelines.

Recent studies have demonstrated the effectiveness of magnetic resonance-guided focused ultrasound (MRgFUS) in the treatment of osteoid osteoma (OO), a painful, benign bone tumor. As MRgFUS is a noninvasive and radiation-free treatment, it stands to replace the current standard of care, percutaneous radiofrequency, or laser thermal ablation. Within an institution, creation of a clinical OO MRgFUS treatment program would not only provide cutting edge medical treatment at the current time but would also establish the foundation for an MRgFUS clinical service to introduce treatments currently under development into clinical practice in the future. The purpose of this document is to provide information to facilitate creation of a clinical service for MRgFUS treatment of OO by providing (1) recommendations for the multi-disciplinary management of patients and (2) guidelines regarding current best practices for MRgFUS treatment. This paper will discuss establishment of a multi-disciplinary clinic, patient accrual, inclusion/exclusion criteria, diagnosis, preoperative imaging, patient preparation, anesthesia, treatment planning, targeting and treatment execution, complication avoidance, and patient follow-up to assure safety and effectiveness.

IR Approaches to Difficult Removals of Totally Implanted Venous Access Port Catheters in Children: A Single-Center Experience.

PURPOSE: To identify factors associated with adherence of implanted venous access port catheters in children and describe technical strategies for removing "stuck" ports. MATERIALS AND METHODS: A retrospective single-center review of port removals was conducted between 2003 and 2012. Cases were identified through radiology reports. Clinical details (eg, demographics, disease, port dwell time, interventional techniques) were obtained through patient charts. Cases were classified as difficult removals if there was documented adherence to soft tissues or vein, or simple removals if no difficulty was recorded. Difficult removals were categorized and graded on increasing invasiveness of techniques required. Successful removal was defined as complete removal of the port catheter. Difficult removals were compared with simple removals for factors associated with difficult removal. Of all removals (N = 1,306), 58 were classified as difficult removals (4%). RESULTS: Using various techniques, 57 of 58 (98%) adherent port catheters were successfully removed. Factors identified with difficult removals included primary diagnosis of acute lymphoblastic leukemia (ALL) (78% vs 37%, P < .0001), age at insertion (3.7 y vs 5.4 y, P = .0019), and port dwell time (median 1,087 d vs 616 d, P < .0001). CONCLUSIONS: Difficulty removing port catheters in children is uncommon. Port catheters can usually be removed successfully using various IR techniques ranging in invasiveness. There is an association of difficult removal with early age at insertion, ALL diagnosis, and long port dwell time. Awareness of these factors may help physicians inform parents of potential difficulties and plan the removal procedure.

Ultrasound-Guided Thrombin Injection for the Treatment of Femoral Pseudoaneurysm in Pediatric Patients.

Eight patients with nine femoral pseudoaneurysms were treated with 13 ultrasound-guided thrombin injections. Mean patient age was 3.3 years (range, 5 mo to 13.6 y), mean pseudoaneurysm diameter was 2.0 cm ± 0.6, and mean thrombin dose was 119 IU (500 IU/mL ± 116; 0.95 CI). Mean follow-up was 27 days (range, 7-120 d). Eight pseudoaneurysms were successfully treated, and one failed to close as a result of arterial wall disease. No complications were observed. The approach used at the authors' pediatric institution resulted in safe and effective treatment of femoral pseudoaneurysms.

The percutaneous cecostomy tube in the management of fecal incontinence in children.

PURPOSE: To retrospectively evaluate experience with percutaneous cecostomies and their long-term outcomes. MATERIALS AND METHODS: Between June 1994 and March 2009, 290 patients (mean age, 10.1 y) with fecal incontinence underwent percutaneous cecostomy tube placement and subsequent tube management. Technical success, procedural complications, and long-term follow-up until March 2012 were evaluated. RESULTS: A cecostomy was successfully placed in 284 patients (98%), and 257 of 280 patients (92%) underwent a successful exchange to a low-profile tube. A total of 1,431 routine exchanges to low-profile tubes were reviewed in 258 patients (mean, 1.6 ± 1.3 routine tube changes per 1,000 days). Eighty-five patients (29%) experienced one or more early problems after cecostomy, and 10 (3%) had major complications. In the total 463,507 tube-days, 938 late problems were noted: 917 (98%) minor and 22 (2%) major. Forty patients had the cecostomy catheter removed and 141 "graduated" to an adult health care facility. CONCLUSIONS: The percutaneous cecostomy procedure provides a safe management option for fecal incontinence in the pediatric population.

Successful use of indwelling tunneled catheters for the management of effusions in children with advanced cancer.

BACKGROUND: Malignant pleural effusion (MPE) and ascites (MA) negatively impact quality of life of palliative patients. Treatment options are limited. This study's purpose is to examine the experience with indwelling tunneled catheters (ITCs) for management of MPE/MA in children with advanced cancer. METHODS: Children with MPE/MA who underwent ITC insertion (2007-2012) were retrospectively reviewed. Clinical, procedural, complication and outcome details were analyzed. RESULTS: PleurX® ITCs (n = 12) were inserted in eight patients (5-18 years) with sarcoma (11 MPE, 1 MA), achieving symptom relief and facilitating discharge home post ITC (median 2 days). Median survival following ITC was 51 days. There were two major complications: pain (n = 1), late site infection (n = 1), and five minor complications. Drainage ceased in four patients (pleurodesis/tumor progression). At time of death, six ITCs (five patients) were still in situ. CONCLUSIONS: ITC appears to be a safe, effective treatment for MPE/MA in advanced pediatric cancer, achieving symptomatic relief and discharge home.

Are cuffed peripherally inserted central catheters superior to uncuffed peripherally inserted central catheters? A retrospective review in a tertiary pediatric center.

PURPOSE: To assess the use of cuffed peripherally inserted central catheters (PICCs) compared with uncuffed PICCs in children with respect to their ability to provide access until the end of therapy. MATERIALS AND METHODS: A retrospective review of PICCs inserted between January 2007 and December 2008 was conducted. Data collected from electronic records included patient age, referring service, clinical diagnosis, inserting team (pediatric interventional radiologists or neonatal intensive care unit [NICU] nurse-led PICC team), insertion site, dates of insertion and removal, reasons for removal, and need for a new catheter insertion. A separate subset analysis of the NICU population was performed. Primary outcome measured was the ability of the PICCs to provide access until the end of therapy. RESULTS: Cuffed PICCs (n = 1,201) were significantly more likely to provide access until the end of therapy than uncuffed PICCs (n = 303) (P = .0002). Catheter removal before reaching the end of therapy with requirement of placement of a new PICC occurred in 26% (n = 311) of cuffed PICCs and 38% (n = 114) of uncuffed PICCs. Uncuffed PICCs had a significantly higher incidence of infections per 1,000 catheter days (P = .023), malposition (P = .023), and thrombus formation (P = .022). In the NICU subset analysis, cuffed PICCs had a higher chance of reaching end of therapy, but this was not statistically significant. CONCLUSIONS: In this pediatric population, cuffed PICCs were more likely to provide access until the end of therapy. Cuffed PICCs were associated with lower rates of catheter infection, malposition, and thrombosis than uncuffed PICCs.

Quality improvement guidelines for pediatric abscess and fluid drainage.

Image-guided drainage of abscesses and fluid collections is a valuable tool in the treatment of pediatric patients. It may obviate surgery or optimize the child's clinical condition for subsequent surgery. Compared with adults, several differences exist in terms of etiology, risks (especially radiation exposure), preprocedural imaging and planning, technical considerations, support issues such as sedation, and complications. Knowledge of these differences is important in the planning and treatment of these patients. In addition, a quality improvement plan can be used to assess practice performance.