3D printing: a useful tool for safe clinical practice in children with complex vasculature.

BACKGROUND: 3D printing has been used in different medical contexts, although it is underutilised in paediatrics. We present the first use of 3D printing in the management of three paediatric patients with complex renovascular disease. METHODS: Patient-specific 3D models were produced from conventional 2D imaging and manufactured using 3D polyjet printing technology. All three patients had different underlying pathologies, but all underwent multiple endovascular interventions (renal artery balloon angioplasty) prior to 3D printing and subsequent vascular surgery. The models were verified by an expert radiologist and then presented to the multidisciplinary team to aid with surgical planning. RESULTS: Following evaluation of the 3D-printed models, all patients underwent successful uni/bilateral renal auto-transplants and aortic bypass surgery. The 3D models allowed more detailed preoperative discussions and more focused planning of surgical approach, therefore enhancing safer surgical planning. It influenced clinical decision-making and shortened general anaesthetic time. The families and the patients reported that they had a significantly improved understanding of the patient's condition and had more confidence in understanding proposed surgical intervention, thereby contributing to obtaining good-quality informed consent. CONCLUSION: 3D printing has a great potential to improve both surgical safety and decision-making as well as patient understanding in the field of paediatrics and may be considered in wider surgical areas.

An analysis of benign prostatic hyperplasia surgical treatment reimbursement trends across Canada: Examining provincial changes over the recent decade with comparison to cost of living changes.

INTRODUCTION: A variety of procedures for the endoscopic surgical treatment of symptomatic benign prostatic hyperplasia (BPH) refractory to medical therapy have existed for decades. The present study examines trends in surgeon compensation for these treatments within Canada. METHODS: The physician fee schedule for BPH surgery across 10 Canadian provinces for the years 2010 and 2023 were obtained. A descriptive study examining first, the provincial reimbursement for transurethral resection of prostate (TURP) and laser ablative/enucleation surgery; second, the difference in TURP reimbursement between 2010 and 2023; and third, the annual change in TURP reimbursement juxtaposed with the annual change in the provincial Consumer Price Index (CPI) and annual salary for the working population aged 35-44. RESULTS: Seven of 10 Canadian provinces reimburse laser BPH surgery equally to TURP. The average provincial TURP reimbursement is $545, ranging from $451 in Ontario to $688 in Saskatchewan. Since 2010, TURP reimbursement has varied by province from a 0% net change in Ontario to an increase of 21% in Nova Scotia. Reimbursement for TURP has increased at a slower pace than the local CPI, and for half of the provinces at a slower pace than the annual salary for people aged 35-44. CONCLUSIONS: The compensation model for endoscopic BPH surgery does not have a unified structure in Canada that is consistent across provinces, nor does it keep up with inflation, possibly impacting future recruitment, increasing geographic disparities, and most importantly, limiting the adoption of new BPH therapies.

Risk of major adverse cardiovascular events in rural vs urban settings among patients with erectile dysfunction: a propensity-weighted retrospective cohort study of 430 621 men.

BACKGROUND: The relationship between erectile dysfunction (ED) and cardiovascular (CV) events has been postulated, with ED being characterized as a potential harbinger of CV disease. Location of residence is another important consideration, as the impact of rural residence has been associated with worse health outcomes. AIM: To investigate whether men from rural settings with ED are associated with a higher risk of major adverse CV events (MACEs). METHODS: A propensity-weighted retrospective cohort study was conducted with provincial health administrative databases. ED was defined as having at least 2 ED prescriptions filled within 1 year. MACE was defined as the first hospitalization for an episode of acute myocardial infarction, heart failure, or stroke that resulted in a hospital visit >24 hours. We classified study groups into ED urban, ED rural, no ED urban, and no ED rural. A multiple logistic regression model was used to determine the propensity score. Stabilized inverse propensity treatment weighting was then applied to the propensity score. OUTCOMES: A Cox proportional hazard model was used to examine our primary outcome of time to a MACE. RESULTS: The median time to a MACE was 2731, 2635, 2441, and 2508 days for ED urban (n = 32 341), ED rural (n = 18 025), no ED rural (n = 146 358), and no ED urban (n = 233 897), respectively. The cohort with ED had a higher proportion of a MACE at 8.94% (n = 4503), as opposed to 4.58% (n = 17 416) for the group without ED. As compared with no ED urban, no ED rural was associated with higher risks of a MACE in stabilized time-varying comodels based on inverse probability treatment weighting (hazard ratio, 1.06-1.08). ED rural was associated with significantly higher risks of a MACE vs no ED rural, with the strength of the effect estimates increasing over time (hazard ratio, 1.10-1.74). CLINICAL IMPLICATIONS: Findings highlight the need for physicians treating patients with ED to address CV risk factors for primary and secondary prevention of CV diseases. STRENGTHS AND LIMITATIONS: This is the most extensive retrospective study demonstrating that ED is an independent risk factor for MACE. Due to limitations in data, we were unable to assess certain comorbidities, including obesity and smoking. CONCLUSIONS: Our study confirms that ED is an independent risk factor for MACE. Rural men had a higher risk of MACE, with an even higher risk among those who reside rurally and are diagnosed with ED.

Anesthetic options for Rezum water vapour therapy: Is minimal sedation tolerable for a minimally invasive procedure?

INTRODUCTION: There has been a rapid expansion of the armamentarium for managing benign prostatic hyperplasia (BPH). Given the invasiveness and complication risks of traditional surgical management, minimally invasive procedures have emerged. Rezum water vapour therapy is a safe, effective alternative. Given the minimally invasive nature, there is interest in administering conscious sedation over general anesthesia (GA) to decrease procedural times and costs and increase accessibility by completing procedures in an office-based setting. We sought to assess and describe patient-reported tolerability for Rezum completed under oral and deep intravenous sedation. METHODS: Patients who underwent Rezum between April and November of 2022 under conscious sedation with oral sedation and local anesthesia (OSLA) or deep intravenous sedation (DIS) were enrolled. Baseline information was collected, and followup interviews were conducted where patient tolerability scores, future anesthetic preferences, and complication data was prospectively obtained. RESULTS: Fourteen patients were enrolled in each group. The OSLA and DIS cohorts had a median tolerability score of 8 (interquartile range [IQR] 3.5) and 9 (IQR=1.75), respectively, indicating highly tolerable experiences. There was no significant difference between groups (p=0.13). On followup, 85.7% of patients in the OSLA and 100% in DIS groups expressed their future preference for conscious sedation over GA, with no significant difference between the two groups (p=0.46). CONCLUSIONS: Our study demonstrates OSLA and DIS are both viable conscious sedation methods for Rezum, with patients reporting high tolerability to the procedure regardless of sedation choice. Almost all patients receiving conscious sedation would choose to undergo Rezum using conscious sedation again and had minimal complications.

Outcomes after chronic isolated epididymal pain: A retrospective study.

INTRODUCTION: Chronic epididymitis imposes significant physical and psychosocial distress on affected patients. Despite being a commonly encountered urologic condition, there remains a paucity of understanding and literature surrounding the management and natural history of isolated epididymal pain. Typically, patients who do not respond to conservative management undergo an epididymectomy.; however, the literature on its efficacy is also scarce, with success rates varying widely from 10-90% in existing studies. Our goal was to better describe the etiology, and natural history of isolated epididymal pain. Furthermore, we aimed to describe the rates of success associated with epididymectomy. METHODS: A retrospective case-control study was conducted at the Manitoba Men's Health Clinic, with the approval of the University of Manitoba Research Ethics Board. All patients presenting with chronic epididymitis, defined as discomfort or pain localized to the epididymis for at least three months, were identified. Information regarding patient demographics, past medical and surgical history, duration of pain, localization of pain, findings on previous ultrasounds, prior conservative therapies trialed and response rates, as well as response rates to surgical therapy were collected. RESULTS: From April 2022 to 2023, a total of 275 patients with chronic orchialgia were identified, and among them, 74 patients specifically presented with chronic isolated epididymal pain. The average duration of symptoms was as follows: 22.9% of patients experienced symptoms for 3-6 months, 10% for 6-12 months, and 67.1% for over 12 months; 13.5% (n=10) had associated ejaculatory pain, 8.1% (n=6) had lower urinary tract symptoms, and 4.1% (n=3) had erectile dysfunction. Ultrasound findings were observed in 68.9% of patients, with 31.1% having an epididymal cyst, 27.1% having a varicocele, 5.4% having a spermatocele, and 4.1% having a hydrocele. Among those who underwent conservative therapy, only 36.2% of patients reported a positive response. Surgical intervention was performed on 23 patients, including 16 who underwent an epididymectomy, three who underwent cord denervation, and two who underwent vasovasostomy and spermatocelectomy each. Most (81.3%, n=13) patients who underwent an epididymectomy had a positive response to the surgical intervention, defined as no pain on followup, while all patients undergoing other surgical interventions experienced a positive response. CONCLUSIONS: Chronic epididymal pain is a condition with limited data surrounding its management. Prior to referral, a large proportion of patients did not undergo any conservative treatment, and of those that did, there was limited response. For those who underwent surgical intervention, all were pain-free on followup, except three patients who underwent epididymectomy.

Preparing Community Health Workers to Empower Latino(a)s With Diabetes: A Real-World Implementation Study.

PURPOSE: The purpose of the study was to evaluate the delivery of diabetes self-management education (DSME) to Latino(a) adults by community health workers (CHWs). METHODS: Investigators developed an evidence-based, bilingual (Spanish/English) diabetes education curriculum and trained 10 CHWs on its content. CHWs then implemented the curriculum in 6-month diabetes group visit programs for low-income Latino(a)s with type 2 diabetes in nonacademic 501(c)3 community clinics. Investigators evaluated efficacy of the training through successful implementation, measured by participant group visit acceptance and attendance. RESULTS: Participants (n = 70) reported high levels of program satisfaction (3.8/4.0), improvement in quality of life (9.7/10), meeting of individual needs (3.8/4.0), and acceptability (9.7/10.0). Content analyses revealed that 87.1% of participants would not change the program or wanted to extend it. Participant attendance was 81.6%. CONCLUSIONS: Investigators demonstrated the ability to develop a training that nonmedical personnel (CHWs) successfully implemented in a real-world study. This study provides a curricular framework for CHW-led education that may serve as a template to extend to other diseases and populations.

Sleep-related painful erections: a survey-based analysis of patient-reported experiences with diagnosis and management.

Sleep-related painful erection (SRPE) is a condition characterized by painful nocturnal erections and frequent nighttime awakenings; however, the pathophysiology is not well understood and existing literature consists mainly of case reports. We aimed to investigate the causes, treatments, and impact on quality of life among individuals affected by SRPE. An e-questionnaire comprising of 30 items was administered to a group of men with SRPE identified through social media in October of 2021. The survey collected information on demographics, clinical and social history, symptomatology, interventions and quality of life. 44 patients with SRPE completed surveys (70.9% response rate), with a mean age ± SD of 43.3 ± 12.8 years. Most respondents had no relevant medical history related to erectile function disorders. 43.2% of subjects reported sleep apnea, and 27.1% reported a mental health disorder or psychiatric medication use. Baclofen was the most common medication, but only 25% of patients found it beneficial. Sleep repositioning, oxygen device use and pelvic floor therapy were interventions that provided the most relief. Most patients did not require emergency department visits (93.2%); only a small number needed penile aspiration (n = 2). As reported by most respondents, SRPE significantly impacted patients' quality of life.

Cardiovascular outcomes improve in children with renovascular hypertension following endovascular and surgical interventions.

BACKGROUND: Renovascular hypertension (RenoVH) is a cause of hypertension in children. A common cause of RenoVH is renal artery stenosis which acts by reducing blood supply to renal parenchyma and activating the renin-angiotensin-aldosterone axis, often leading to cardiac remodelling. This longitudinal observational study aims to describe occurrence of cardiovascular changes secondary to RenoVH and also any improvement in cardiac remodelling after successful endovascular and/or surgical intervention. METHODS: All patients with RenoVH referred to our centre, who received ≥ 1 endovascular intervention (some had also undergone surgical interventions) were included. Data were collected by retrospective database review over a 22-year period. We assessed oscillometric blood pressure and eight echocardiographic parameters pre- and post-intervention. RESULTS: One hundred fifty-two patients met inclusion criteria and had on average two endovascular interventions; of these children, six presented in heart failure. Blood pressure (BP) control was achieved by 54.4% of patients post-intervention. Average z-scores improved in interventricular septal thickness in diastole (IVSD), posterior Wall thickness in diastole (PWD) and fractional shortening (FS); left ventricular mass index (LVMI) and relative wall thickness (RWT) also improved. PWD saw the greatest reduction in mean difference in children with abnormal (z-score reduction 0.25, p < 0.001) and severely abnormal (z-score reduction 0.23, p < 0.001) z-scores between pre- and post-intervention echocardiograms. Almost half (45.9%) had reduction in prescribed antihypertensive medications, and 21.3% could discontinue all antihypertensive therapy. CONCLUSIONS: Our study reports improvement in cardiac outcomes after endovascular + / - surgical interventions. This is evidenced by BP control, and echocardiogram changes in which almost half achieved normalisation in systolic BP readings and reduction in the number of children with abnormal echocardiographic parameters. A higher resolution version of the Graphical abstract is available as Supplementary information.

Outcomes and patient tolerability of radical inguinal orchiectomy under deep intravenous sedation.

INTRODUCTION: Radical inguinal orchiectomy (RO ) is indicated for the management of testicular tumors and is universally performed under general anesthetic in the hospital. The need to perform radical orchiectomy in an expeditated fashion can result in logistical difficulties, often necessitating this procedure to happen after-hours on a semi-emergent basis. These logistical difficulties have been exacerbated by the backlog of cases from the COVID-19 pandemic. A similar procedure - inguinal hernia repair - is regularly performed under local anesthesia with minimal complications. Thus, we sought to evaluate the feasibility of performing radical orchiectomy under deep intravenous sedation in an ambulatory surgery center. METHODS: We evaluated our single-surgeon (PP), prospective database of patients who underwent RO between September 2022 and February 2023 at the Men's Health Clinic Manitoba. Patients were given a combination of deep sedation, ilioinguinal nerve block, and local anesthetic. Tolerability was assessed both perioperatively and at 4-6 weeks' followup. We reviewed the medical records for any postoperative complications. RESULTS: Eight patients underwent RO under deep sedation during the study period. All patients tolerated the surgery well and were discharged shortly after surgery. Average operative time was 40 minutes and length of stay was 46 minutes. There were no perioperative complications. CONCLUSIONS: Our pilot study demonstrates that RO can be safely and effectively performed under deep sedation. This anesthetic combination can be used both in-hospital and out-of-hospital settings, thereby resulting in faster recovery, shorter length of stay, and favorable patient and provider satisfaction.

Evaluating Patient Tolerability for Urological Procedures Under Conscious Sedation: A Prospective Study.

OBJECTIVE: To prospectively evaluate patient-reported tolerability and surgical outcomes of urologic procedures with conscious sedation with or without local anesthesia. Administration of general or spinal anesthesia is associated with anesthetic-related complications, long wait times, and high costs. Using intravenous conscious sedation and/or local anesthesia is an emerging alternative for a myriad of urologic procedures. METHODS: Patients were enrolled from June-August 2021 at a tertiary care hospital. All procedures were completed using fentanyl, midazolam, or both with patient and procedural data recorded upon completion. Patients were telephoned 4-6 weeks post-procedure with a standardized patient tolerability questionnaire. A multivariable adjusted logistic regression analysis was performed to evaluate whether a patient would opt for conscious sedation again as opposed to general anesthesia. RESULTS: A total of 196 procedures were performed by 6 attending urologists with an overall success rate of 98.5% and 0% intraoperative complication rate. At 4-6 weeks follow-up, 85.6% of patients reported they would opt for conscious sedation as opposed to general anesthesia. Predictors of opting for conscious sedation in the future were older age (Odds Ratio (OR): 1.049; P = .017) and surgeon perceived level of patient tolerability (OR: 2.124; P <.001, scored 1-10). CONCLUSION: Physician directed, nursing administered IV conscious sedation is a viable alternative for various urologic procedures and has minimal risk of perioperative complications.

A social innovation to empower community-led monitoring and mobilization for HIV prevention in rural Kenya: experimenting to reduce the HIV prevention policy-implementation gap.

Introduction: Strong policy guidance has recently emerged identifying focal points at multiple levels and across sectors to end the persistent HIV pandemic and related inequities. Reducing the policy-implementation gap, as with the evidence-policy gap, requires strategic alignment between interventional research and policy realms. Global- and national-level HIV policy indicate a need for community-led efforts to reduce HIV stigma, and increase uptake of HIV prevention tools. Methods: This study assesses a process-driven approach to facilitating community-led efforts to reduce HIV stigma, and build a generative context for community-led HIV prevention. The study intervention combines an adapted group-based microfinance process, a novel psychological curriculum, and leadership development at a scale now involving over 10,000 rural Kenyans across 39 villages. Results: Consistent with interventional goals, and current relevant psychosocial theories, we find collective emotion, and HIV stigma (blame and discrimination) significantly improve with more time participating in the in the program and novel curriculum. Further, HIV stigma predicts subsequent reporting of ever being tested for HIV, and the intervention led to the development of "HIV prevention resource committees" - groups of participants committed to undergo training to reduce HIV stigma and prevent HIV within their communities. Discussion: Implications for further research to reduce the HIV policy-implementation gap are discussed, directly within this interventional context and more generally.

The impact of misinformation on patient perceptions at a men's health clinic: a cross-sectional study.

Misinformation is a rising concern for providers and patients alike. We aimed to assess where patients acquire information prior to their andrological urologic appointment and assess patients' perception regarding the reliability of this information. A cross-sectional study was conducted at an outpatient men's health clinic between June and August of 2022 with questionnaires distributed to adult males seen for their primary visit. The study included 314 consenting adult patients who independently completed the questionnaire (mean age: 51.2 ± 17.2). Overall, 55.1% of patients indicated they searched for their condition online. However, 39.2% and 27.7% of respondents agreed and strongly agreed, respectively, that misinformation is a concern when searching for health information. Only 59.9% of patients discussed their concerns with others and those that did not chose not wanting to (65.1%) as their top choice. However, 27.4% of respondents were embarrassed to do so. Finally, 38.2% and 12.4% of patients agreed and strongly agreed, that learning information prior to your appointment affects their relationship with the physician. These findings emphasize the need for urologists to be aware of where their patients are gathering health information and to address concerns regarding misinformation.

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.

Insurance approval rates for collagenase clostridium histolyticum prior to discontinuation: a Canada-wide analysis.

Collagenase Clostridium histolyticum (CCh), the first approved non-surgical treatment for Peyronie's disease (PD), was withdrawn from the European, Canadian, and Asian markets due to poor demand and lack of government reimbursement options. We sought to assess insurance approval rates and usage of CCh across Canada to understand the factors that led to its withdrawal. Data on patients prescribed CCh for PD or Dupuytren's contracture was obtained through collaboration with BioScript Solutions to assess the association of variables with insurance approval and prescription filling. We identified 3297 insurance coverage applications for Xiaflex® from April 2018 to June 2020. Of all applications for PD, 92.9% applications were approved while 7.1% were rejected. Despite the withdrawal of CCh from Canadian markets, coverage application approval rates for 2018, 2019, and 2020 were 86.5%, 90.1%, and 89.1%, respectively. Of 2921 approved applications, 88.8% prescriptions were filled. For the 376 rejected applications, 66.4% of prescriptions were filled. Overall, 90% of the cost of Xiaflex® was covered in Canada among those with extended health benefits, with an out-of-pocket expense of $210.4. Insurance coverage requests for Xiaflex® were approved at a high rate in Canada with approved patients being very likely to proceed with therapy, despite interprovincial variation.

Use of super resolution reconstruction MRI for surgical planning in Placenta accreta spectrum disorder: Case series.

INTRODUCTION: Comprehensive imaging using ultrasound and MRI of placenta accreta spectrum (PAS) aims to prevent catastrophic haemorrhage and maternal death. Standard MRI of the placenta is limited by between-slice motion which can be mitigated by super-resolution reconstruction (SRR) MRI. We applied SRR in suspected PAS cases to determine its ability to enhance anatomical placental assessment and predict adverse maternal outcome. METHODS: Suspected PAS patients (n = 22) underwent MRI at a gestational age (weeks + days) of (32+3±3+2, range (27+1-38+6)). SRR of the placental-myometrial-bladder interface involving rigid motion correction of acquired MRI slices combined with robust outlier detection to reconstruct an isotropic high-resolution volume, was achieved in twelve. 2D MRI or SRR images alone, and paired data were assessed by four radiologists in three review rounds. All radiologists were blinded to results of the ultrasound, original MR image reports, case outcomes, and PAS diagnosis. A Random Forest Classification model was used to highlight the most predictive pathological MRI markers for major obstetric haemorrhage (MOH), bladder adherence (BA), and placental attachment depth (PAD). RESULTS: At delivery, four patients had placenta praevia with no abnormal attachment, two were clinically diagnosed with PAS, and six had histopathological PAS confirmation. Pathological MRI markers (T2-dark intraplacental bands, and loss of retroplacental T2-hypointense line) predicting MOH were more visible using SRR imaging (accuracy 0.73), in comparison to 2D MRI or paired imaging. Bladder wall interruption, predicting BA, was only easily detected by paired imaging (accuracy 0.72). Better detection of certain pathological markers predicting PAD was found using 2D MRI (placental bulge and myometrial thinning (accuracy 0.81)), and SRR (loss of retroplacental T2-hypointense line (accuracy 0.82)). DISCUSSION: The addition of SRR to 2D MRI potentially improved anatomical assessment of certain pathological MRI markers of abnormal placentation that predict maternal morbidity which may benefit surgical planning.

A prospective evaluation of patient perspectives and financial considerations during prostate cancer treatment decision-making.

INTRODUCTION: In universal healthcare systems, patients may still encounter financial obstacles from cancer treatments, potentially influencing treatment decision-making. We investigated the relationship between socioeconomic status and treatment decision-making as it pertains to patient values, preferences, and perceived barriers to care for localized prostate cancer. METHODS: We conducted a prospective study of patients undergoing a prostate biopsy for the initial detection of prostate cancer. Sociodemographic variables were collected, with validated instruments used to determine health literacy levels. Patients were divided into two groups using self-reported income; those with a positive identification of prostate cancer underwent additional surveys to ascertain their knowledge of their diagnosis, treatment-related preferences, and socioeconomic barriers to care. Descriptive statistics were used. RESULTS: Of 160 patients, approximately one-third were classified as having low health literacy. Within the low-income group, education levels were lower (34.6% had less than high school education vs. 10.2% in the high-income group) and unemployment rates higher (75.0% unemployed vs. 38.9% in the high-income group). Low-income patients with prostate cancer placed greater importance on indirect out-of-pocket expenses related to treatment (78.3% vs. 33.3%, p=0.001), higher emphasis on treatment-related travel time (50% vs. 15.1%, p=0.004), and more often had difficulty paying for healthcare services in the past (30.9% vs. 9.1%, p=0.02). CONCLUSIONS: Patients with lower household incomes have unique treatment values and decision-making preferences. They may experience additional challenges and barriers to obtaining cancer care, at least partly related to indirect costs. These findings should be considered when framing prostate cancer treatment discussions and designing patient-facing health information.

Is There Really No Kit for Kids? Quantification of Manufacturer Recommendations Regarding Paediatric Use For High-Volume IR Devices.

AIMS: The development of paediatric specific devices appears to lag behind advancements in our specialty. Children could therefore be limited in the number of procedures available to them unless we continue to use and modify adult devices 'off-label'. This study quantifies the proportion of IR devices in which paediatric use is indicated by the manufacturer. MATERIALS & METHODS: Cross-sectional analysis of device instructions for use (IFU), assessing inclusion of children was performed. Vascular access, biopsy, drainage, and enteral feeding devices, from 28 companies who sponsored BSIR, CIRSE and SIR (2019-2020) as determined by the meeting websites, were included. Devices for which the IFU was not available were excluded. RESULTS: 190 (106 vascular access, 40 biopsy, 39 drainage and 5 feeding) devices with IFU's from 18 medical device manufacturers were assessed. 49/190 (26%) IFU's referenced children. 6/190 (3%) explicitly stated the device could be used in children and 1/190 (0.5%) explicitly stated the device was not for use in children. 55/190 (29%) implied they could be used in children through caution notes. The most common caution was a reference to the size of the device that could be accommodated in a child (26/190, 14%). CONCLUSIONS: This data identifies an unmet need for paediatric IR devices and could be used to support the future development of devices intended for the children we treat. There is potentially a larger proportion (29%) of devices suitable for paediatric use, but which lack manufacturer explicit support. LEVEL OF EVIDENCE: Level 2c, Cross-Sectional study.