Balancing pediatric device utility and harm: navigating the challenges for safer healthcare.

This article discusses the challenges in balancing the utility and harm associated with pediatric medical devices. Takashima et al. explored the prevalence and complications of invasive devices across three Australian pediatric tertiary hospitals and reported a high prevalence of complications, particularly with vascular access devices. We also highlight the need to pay attention to the use of these devices, particularly intravenous catheters, and the importance of a culture of patient safety in healthcare systems. We emphasize the need for a nuanced approach that carefully weighs the benefits against potential risks and encourages collaboration among stakeholders to establish robust regulatory frameworks and prioritize the safety and well-being of pediatric patients. Finally, we conclude by advocating the involvement of parents and families in gathering information about hospital safety incidents and fostering a culture of safety that supports reporting, flexibility, and learning. IMPACT: Reporting adverse events and their consequences is essential in the strategy to prevent them, allowing comparison with national or international standards, and identifying indicators to optimize and harbor the possibility of determining improvement measures that pursue a multifactorial approach and are cost-effective. Our comment advocates limiting the prevalence of medical invasive devices and their consequences by reviewing their epidemiology. Although advancements in medical technology have undoubtedly improved the diagnostic and therapeutic possibilities, the delicate balance between device utility and potential harm necessitates careful consideration.

Pediatric invasive device utility and harm: a multi-site point prevalence survey.

BACKGROUND AND AIMS: Invasive devices are widely used in healthcare settings; however, pediatric patients are especially vulnerable to invasive device-associated harm. This study aimed to explore invasive device utility, prevalence, harm, and clinical practice across three Australian pediatric tertiary hospitals. METHODS: In 2022-2023, a multi-center, observational, rolling-point-prevalence survey was conducted. Fifty-per-cent of inpatients were systemically sampled by random allocation. Patients with devices were then followed for up to 3-days for device-related complications/failures and management/removal characteristics. RESULTS: Of the 285 patients audited, 78.2% had an invasive device (n = 412 devices), with a median of 1 device-per-patient (interquartile range 1-2), with a maximum of 13 devices-per-patient. Over half of devices were vascular access devices (n = 223; 54.1%), followed by gastrointestinal devices (n = 112; 27.2%). The point-prevalence of all device complications on Day 0 was 10.7% (44/412 devices) and period-prevalence throughout the audit period was 27.7% (114/412 devices). The period-prevalence of device failure was 13.4% (55/412 devices). CONCLUSIONS: The study highlighted a high prevalence of invasive devices among hospitalized patients. One-in-ten devices failed during the audit period. These findings underscore the need for vigilant monitoring and improved strategies to minimize complications and enhance the safety of invasive devices in pediatric hospital settings. IMPACT: A high prevalence of invasive devices among hospitalized patients was reported. Of the 285 patients audited, almost 80% had an invasive device (total 412 devices), with a median of 1 device-per-patient and a maximum of 13 devices-per-patient. The most common devices used in pediatric healthcare are vascular access devices (n = 223; 54.1%), however, 16% (n = 36) of these devices failed, and one-third had complications. The point prevalence of all device complications at day 0 was 10.7% (44 out of 412 devices), with a period prevalence of 27.7% (114 out of 412 devices) throughout the audit period.

Vascular access devices for prolonged intravenous therapy regimens in people diagnosed with cancer.

OBJECTIVES: This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the relative effectiveness and vascular access device (VAD)-related complications of VADs in people requiring prolonged systemic anti-cancer treatment.

Vascular Port Complication Leading to Surgery of Pulmonary Artery Branch-A Case Report.

A vessel port, implanted into the central venous system, is used for long-term intravenous drug administration in oncology patients. Although essential for frequent chemotherapy and other treatments, ports can lead to complications such as infection and thrombosis. This article discusses a rare but serious complication: the displacement of a catheter fragment. A 67-year-old gastric cancer patient, experienced malignant recurrence with jaundice and bile duct infiltration post Roux-Y subtotal gastrectomy and D2 lymphadenectomy. After nine cycles of chemotherapy, a catheter fragment from the venous port detached and lodged in a branch of the pulmonary artery in segment VIII of the right lung. Thoracotomy was performed to remove the foreign body. Our aim is to report on the surgical treatment of a displaced detached catheter and to raise awareness about the potential rare complications associated with the use of vascular ports in patients undergoing chronic oncological treatment. Additionally, we screened the PubMed database for similar surgical treatment reports and compared the collected data. Venous port malfunction or non-specific patient symptoms may indicate rare complications, such as port component detachment, necessitating a multidisciplinary approach for prompt diagnosis and management in oncological patients.

A safe and effective winged peripheral intravenous cannula for use in clinical practice.

Vascular access continues to be a key factor for the reliable and safe delivery of intravenous (IV) therapy to patients in any healthcare setting. Clinical guidelines advocate for the right vascular access device selection, in order to reduce avoidable complications, eg multiple stabs, phlebitis, thrombophlebitis, insertion site infection, and blood stream infection, while improving efficiency and reducing costs. Peripheral intravenous catheters or cannulas (PIVCs) remain widely used for gaining vascular access in all clinical settings, with both adults and children, because they provide a relatively cheap and simple way to provide blood sampling and the prompt administration of IV medications. Although safe and easy to insert, PIVCs present with associated risks that can be costly to the organisation. The case studies included with this article introduce Nipro's Safetouch Cath Winged with Injection Port as a new cost-effective choice of PIVC, which is now available from NHS Supply Chain.

Extravasation and infiltration: under-recognised complications of intravenous therapy.

Occasionally, the administration of intravenous (IV) therapies can go wrong. Infiltration or extravasation is a complication when a drug or IV therapy leaks into the tissues surrounding the vascular access device. Extravasation can cause serious and often life-changing injuries. Extravasation is often associated with systemic anti-cancer therapy but non-chemotherapy drugs have been reported as having a greater risk of serious complications. This study outlines the first UK Infusion unit evaluation of the ivWatch infusion monitoring device which was undertaken from August 2023 to January 2024. Out of 2254 infusions monitored with ivWatch, the device prevented 122 cases of infiltration and extravasation from causing any harm to the patient, corresponding to a 5.4% 'check IV' notification rate.

Drug-Coated Balloons for Dysfunctional Dialysis Arteriovenous Fistulas.

BACKGROUND: Standard percutaneous transluminal angioplasty is the current recommended treatment for dysfunctional hemodialysis fistulas, yet long-term outcomes of this treatment are poor. Drug-coated balloons delivering the antirestenotic agent paclitaxel may improve outcomes. METHODS: In this prospective, single-blinded, 1:1 randomized trial, we enrolled 330 participants at 29 international sites. Patients with new or restenotic lesions in native upper-extremity arteriovenous fistulas were eligible for participation. After successful high-pressure percutaneous transluminal angioplasty, participants were randomly assigned to receive treatment with a drug-coated balloon or a standard balloon. The primary effectiveness end point was target-lesion primary patency, defined as freedom from clinically driven target-lesion revascularization or access-circuit thrombosis during the 6 months after the index procedure. The primary safety end point, serious adverse events involving the arteriovenous access circuit within 30 days, was assessed in a noninferiority analysis (margin of noninferiority, 7.5 percentage points). The primary analyses included all participants with available end-point data. Additional sensitivity analyses were performed to assess the effect of missing data. RESULTS: A total of 330 participants underwent randomization; 170 were assigned to receive treatment with a drug-coated balloon, and 160 were assigned to receive treatment with a standard balloon. During the 6 months after the index procedure, target-lesion primary patency was maintained more often in participants who had been treated with a drug-coated balloon than in those who had been treated with a standard balloon (82.2% [125 of 152] vs. 59.5% [88 of 148]; difference in risk, 22.8 percentage points; 95% confidence interval [CI], 12.8 to 32.8; P<0.001). Drug-coated balloons were noninferior to standard balloons with respect to the primary safety end point (4.2% [7 of 166] and 4.4% [7 of 158], respectively; difference in risk, -0.2 percentage points; 95% CI, -5.5 to 5.0; P = 0.002 for noninferiority). Sensitivity analyses confirmed the results of the primary analyses. CONCLUSIONS: Drug-coated balloon angioplasty was superior to standard angioplasty for the treatment of stenotic lesions in dysfunctional hemodialysis arteriovenous fistulas during the 6 months after the procedure and was noninferior with respect to access circuit-related serious adverse events within 30 days. (Funded by Medtronic; IN.PACT AV Access Study ClinicalTrials.gov number, NCT03041467.).

Haemodialysis vascular catheter-related blood stream infection: Organism types and clinical outcomes.

Catheter-related bloodstream infection (CRBI) is an important complication of catheter use for haemodialysis, but it remains unclear whether clinical outcomes following CRBI are influenced by organism type. This study aims to compare clinical outcomes following CRBI from Gram-positive and non-Gram-positive organisms. This was a retrospective cohort study of patients with kidney failure receiving haemodialysis (HD) via vascular catheters who had a documented episode of CRBI in Western Australia between 2005 and 2018. The associations between organism type, likelihood of hospitalization, catheter removal and death from CRBI were examined using adjusted logistic regression models. There were 111 episodes of CRBI in 99 patients (6.1 episodes per 1000-catheter-days at risk). Of the study cohort, 53 (48%) were male and 38 (34%) identified as Aboriginal or Torres Strait Islander. Gram-positive organisms were identified in 73 (66%) CRBI episodes, most commonly Staphylococcus aureus. Of those with non-Gram-positive CRBI, 9 (24%) were attributed to Pseudomonas aeruginosa. One-hundred and two (92%) episodes of CRBI required hospitalization and 15 (13%) patients died from CRBI. Compared with non-Gram-positive CRBI, Gram-positive CRBI was associated with an increased risk of hospitalization and catheter removal, with adjusted odds ratio of 9.34 (95% CI 1.28-68.03) and 3.47 (95% CI 1.25-9.67), respectively. There was no association between organism type and death from CRBI. Staphylococcus aureus remains the most common organism causing CRBI in HD patients. CRBI is associated with substantial morbidity, particularly CRBI attributed to Gram-positive organisms.

Incidence of venous thromboembolic events not related to vascular catheters in a prospective cohort of critically ill children.

The risk for venous thromboembolism (VTE) is considered to be low in the general paediatric intensive care unit (PICU) population, and pharmacological thromboprophylaxis is not routinely used. PICU patients considered at high-risk of VTE could possibly benefit from pharmacological thromboprophylaxis, but the incidence of VTE in this group of patients is unclear. This was an observational, prospective study at a tertiary multi-disciplinary paediatric hospital. We used comprehensive ultrasonography screening for VTE in critically ill children with multiple risk factors for VTE. Patients admitted to PICU ≥ 72 h and with ≥ two risk factors for VTE were included. Patients receiving pharmacological thromboprophylaxis during their entire PICU stay were excluded. The primary outcome of the study was VTEs not related to the use of a CVC. Ultrasonography screening of the great veins was performed at PICU discharge. Seventy patients with median (interquartile range) 3 (2-4) risk factors for VTE were evaluated. Median age was 0.3 years (0.03-4.3) and median PICU length of stay 9 days (5-17). Regarding the primary outcome, no symptomatic VTEs occurred and no asymptomatic VTEs were found on ultrasonography screening, resulting in an incidence of VTEs not related to a vascular catheter of 0% (95% CI: 0-5.1%). CONCLUSION: Our results indicate that VTEs not related to a vascular catheter are a rare event even in a selected group of severely ill small children considered to be at high risk of VTE. WHAT IS KNOWN: • Children in the PICU often have several risk factors for venous thromboembolism (VTE). • The incidence of VTE in PICU patients is highly uncertain, and there are no evidence-based guidelines regarding VTE prophylaxis. WHAT IS NEW: • This study found an incidence of VTEs not related to a vascular catheter of 0% (95% CI: 0-5.1%). • This indicates that such VTE events are rare even in PICU patients with multiple risk factors for VTE.

Patterns of vascular access device use and thrombosis outcomes in patients with COVID-19: a pilot multi-site study of Michigan hospitals.

Venous thromboembolism (VTE) is an important complication of coronavirus disease 2019 (COVID-19). To date, few studies have described vascular access device use and VTE risk in this cohort. To examine the use of vascular access devices and incidence of VTE in patients hospitalized with COVID-19. We performed a retrospective, multi-center cohort study of patients hospitalized with COVID-19 who received a midline catheter, peripherally inserted central catheter (PICCs), tunneled or non-tunneled central venous catheter (CVC), hemodialysis (HD) catheter or a port during hospitalization. Mixed-effects multivariable logit models adjusting for VTE risk factors in the Caprini risk score were fit to understand the incremental risk of VTE in patients with vascular access devices vs. those that did not receive devices. Management of VTE was determined by examining anticoagulant use pre- vs. post-thrombosis. Results were expressed using odds ratios (ORs) and associated 95% confidence intervals (CI). A total of 1228 hospitalized COVID-19 patients in 40 hospitals, of which 261 (21.3%) received at least one vascular access device of interest, were included. The prevalence of acute, non-tunneled CVCs was 42.2%, acute HD catheters 18.4%, midline catheters 15.6%, PICCs 15.6%, tunneled CVCs 6.8%, and implanted ports 1.4%. The prevalence of VTE was 6.0% in the study cohort, and 10.0% among patients with vascular access devices. After adjusting for known VTE risk factors, patients that had a vascular access device placed were observed to have a four-fold greater odds of VTE than those that did not (OR 4.17, 95% CI 2.33-7.46). Patients who received multiple different catheters experienced more VTE events compared with patients that received only one type (21.5% vs. 6.1%, p < .001). Among the 26 patients with VTE, only 8 (30.8%) survived to discharge and among these, only 5 were discharged on therapeutic doses of anticoagulation. Hospitalized patients with COVID-19 that receive vascular access devices experienced higher rates of VTE than those that do not. Future studies to evaluate the nexus between COVID-19, vascular device use, and thrombosis appear are warranted.

Use of plastic adhesive skin drapes in cancer patients undergoing totally implantable vascular access port (TIVAP) placement-a randomized controlled pilot study.

PURPOSE: A totally implantable vascular access port (TIVAP) is commonly required in cancer patients. Possible adverse events after TIVAP implantation include surgical site infection (SSI) and port-related bacteremia. This study examined whether adhesive surgical drapes can reduce the risk of SSI. METHODS: A total of 100 mostly cancer patients were randomized into two groups before undergoing TIVAP implantation by surgical cut-down. In one group, an adhesive, non-impregnated drape was applied to the skin prior to incision, while the control group underwent surgery without a drape. Swabs were taken from the surgical site and sent for microbiologic testing. SSI rates were compared between groups. RESULTS: No SSI occurred within 30 days after surgery. In each group, two patients died. There were 5 complications (port thrombosis, port dislocation, two cases of pneumothorax, skin allergy), all in the intervention group (p = 0.056). Using the incision drape prolonged procedure time by + 5 min (95% CI - 1 to + 10, p = 0.125). Microbiologic swab testing failed to detect any effect of the incision drape. CONCLUSIONS: Plastic adhesive skin drapes may be unnecessary in cancer patients who undergo surgical implantation of a TIVAP.

A quality improvement project: Reducing bloodstream infection by improving adherence to the care bundle of peripheral vascular catheters at the COVID-19 treatment centre.

INTRODUCTION: During the COVID-19 pandemic, bloodstream infection (BSI) rates were substantially rising in Sungai Buloh Hospital (HSB). It is believed that the COVID-19 pandemic has had an adverse impact on BSI incidence caused by contaminated periphery vascular catheters (PVCs). The study's objective is to reduce the BSI rates in HSB by improving adherence to the PVC care bundle via the Plan-Do-Study-Act (PDSA) approach. MATERIALS AND METHODS: A quality improvement (QI) project was employed over four months, from June to September 2021, during the COVID-19 pandemic in HSB. All adults hospitalised for COVID-19 with intravenous lines were subjected to data collection. A baseline audit was conducted to study BSI incidence from April to May 2021. Implementation was carried out by PDSA cycles and data on BSI rates per 100 admissions was described using a monthly run chart. RESULTS: At baseline, the BSI rate per 100 admissions was 5.44 before implementing our QI project. Initial changes via PDSA cycles did not bring significant improvements to BSI rates and a rising trend in BSI rates was observed after two PDSA cycles. Further audits identified the problem of noncompliance with the practice of aseptic non-touch technique (ANTT) and a lack of effective leadership in implementing the PVC care bundle. The third PDSA cycle focused on adopting practical leadership skills among senior clinicians to ensure compliance with the prevention bundle and to encourage the use of ultrasound guidance for difficult line insertion. After the third PDSA cycle, the BSI rate per 100 admissions was reduced from 6.41 to 4.34 (p < 0.05). The BSI rates continued to decline down the line for another five months. CONCLUSION: Through QI initiatives, the risk of BSI can be significantly reduced.

Arteriovenous access placement and renal function decline.

BACKGROUND: There is controversial evidence on whether arteriovenous access (AVA) placement may protect renal function and hence should be considered in the timing of access placement. This study aimed to investigate the association between AVA placement and estimated glomerular filtration rate (eGFR) decline as compared with the placement of a peritoneal dialysis catheter (PDC) at a similar time point. METHODS: We studied a cohort of 744 pre-dialysis patients in Stockholm, Sweden, who underwent surgery for AVA or PDC between 2006 and 2012. Data on comorbidity, medication and laboratory measures were collected 100 days before and after surgery. Patients were followed until dialysis start, death or 100 days, whichever came first. The primary outcome was difference in eGFR decline after AVA surgery compared with PDC. Decline in eGFR was estimated through linear mixed models with random intercept and slope, before and after surgery. RESULTS: There were 435 AVA and 309 PDC patients. The AVA patients had higher eGFR (8.1 mL/min/1.73 m2 versus 7.0 mL/min/1.73 m2) and less rapid eGFR decline before surgery (-5.6 mL/min/1.73 m2/year compared with -6.7 mL/min/1.73 m2/year for PDC). We found no difference in eGFR decline after surgery in AVA patients compared with PDC patients [AVA progressed 0.26 (95% confidence interval -0.88 to 0.35) mL/min/1.73 m2/year faster after surgery compared with PDC]. CONCLUSIONS: There was no significant difference in eGFR decline after placement of an AVA compared with a PDC. Both forms of access were associated with reduced eGFR decline in our population. The need for dialysis remains the main determinant for timing of access surgery.

Feasibility and outcomes of native arteriovenous fistula in octogenarians.

INTRODUCTION: While the native arteriovenous fistula (AVF) is the preferred dialysis access, it is a matter of debate for individuals older than 80 years due to reduced primary patency rates. MATERIALS AND METHODS: We initiated a single-center, observational retrospective analysis of adult dialysis patients from January 2015 to December 2018. We included all patients older than 70 years with a minimum of 12 months of follow-up, beginning from the AVF creation. Patients were separated into two groups, octogenarians (> 80 years old) and controls (70 - 79 years old). The primary end point was the primary patency (the interval from arteriovenous access creation to the first intervention). The secondary end point were the complications at 3 months (failures of puncture, canceled dialysis sessions, local hematoma, AVF bleeding). RESULTS: 29 patients (octogenarian = 17, control = 12) were included in the analysis. The AVF radio-cephalic was the most common vascular access in each group. Primary patency was comparable between groups, but octogenarians required 40% more procedures to obtain or maintain patency. Overall, a functional AVF was obtained for all patients except in cases of complications such as hematomas, which were more frequent in octogenarians compared to controls (25 vs. 82%, p < 0.01). All catheters were removed at 6 months follow-up, with a median time to removal of 27 days (range 5 - 157 days). DISCUSSION: Despite a higher rate of interventions and local complications during the first 3 months, AVF and particularly radio-cephalic AVF, is a valid procedure for octogenarians, without lengthening the exposure time to the catheter.

Rates of Venous Thromboembolism and Central Line-Associated Bloodstream Infections Among Types of Central Venous Access Devices in Critically Ill Children.

OBJECTIVES: Central venous access devices, including peripherally inserted central catheters and central venous catheters, are often needed in critically ill patients, but also are associated with complications, including central-line associated bloodstream infections and venous thromboembolism. We compared different central venous access device types and these complications in the PICU. DESIGN: Multicenter, cohort study. SETTING: One hundred forty-eight participating Virtual PICU Systems, LLC, hospital PICU sites. PATIENTS: Pediatric patients with central venous access placed from January 1, 2010, to December 31, 2015. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Patient and central venous access device variables postulated to be associated with central-line associated bloodstream infection and venous thromboembolism were included. Data were analyzed using Pearson chi-square test or Fisher exact test for categorical variables, Mann-Whitney U test for continuous variables, and logistic regression and classification trees for multivariable analysis that examined significant predictors of venous thromboembolism or central-line associated bloodstream infection. Analysis included 74,196 first lines including 4,493 peripherally inserted central catheters and 66,194 central venous catheters. An increased rate of venous thromboembolism (peripherally inserted central catheter: 0.93%, central venous catheter: 0.52%; p = 0.001) (peripherally inserted central catheter: 8.65/1,000 line days, central venous catheter: 6.29/1,000 line days) and central-line associated bloodstream infection (peripherally inserted central catheter: 0.73%, central venous catheter: 0.24%; p = 0.001) (peripherally inserted central catheter: 10.82/1,000 line days, central venous catheter: 4.97/1,000 line days) occurred in peripherally inserted central catheters. In multivariable analysis, central venous catheters had decreased association with central-line associated bloodstream infection (odds ratio, 0.505; 95% CI, 0.336-0.759; p = 0.001) and venous thromboembolism (odds ratio, 0.569; 95% CI, 0.330-0.982; p = 0.043) compared with peripherally inserted central catheters. CONCLUSIONS: Peripherally inserted central catheters are associated with higher rates of central-line associated bloodstream infection and venous thromboembolism than central venous catheters in children admitted to the PICU.

Risk of Vascular Access Infection Associated With Buttonhole Cannulation of Fistulas: Data From the National Healthcare Safety Network.

RATIONALE & OBJECTIVE: Compared with conventional (rope-ladder cannulation [RLC]) methods, use of buttonhole cannulation (BHC) to access arteriovenous fistulas (AVFs) may be associated with increased risk for bloodstream infection and other vascular access-related infection. We used national surveillance data to evaluate the infection burden and risk among in-center hemodialysis patients with AVFs using BHC. STUDY DESIGN: Descriptive analysis of infections and related events and retrospective observational cohort study using National Healthcare Safety Network (NHSN) surveillance data. SETTING & PARTICIPANTS: US patients receiving hemodialysis treated in outpatient dialysis centers. PREDICTORS: AVF cannulation methods, dialysis facility characteristics, and infection control practices. OUTCOMES: Access-related bloodstream infection; local access-site infection; intravenous (IV) antimicrobial start. ANALYTIC APPROACH: Description of frequency and rate of infections; adjusted relative risk (aRR) for infection with BHC versus RLC estimated using Poisson regression. RESULTS: During 2013 to 2014, there were 2,466 access-related bloodstream infections, 3,169 local access-site infections, and 13,726 IV antimicrobial starts among patients accessed using BHC. Staphylococcus aureus was the most common pathogen, present in half (52%) of the BHC access-related bloodstream infections. Hospitalization was frequent among BHC access-related bloodstream infections (37%). In 2014, 9% (n=271,980) of all AVF patient-months reported to NHSN were associated with BHC. After adjusting for facility characteristics and practices, BHC was associated with significantly higher risk for access-related bloodstream infection (aRR, 2.6; 95% CI, 2.4-2.8) and local access-site infection (aRR, 1.5; 95% CI, 1.4-1.6) than RLC, but was not associated with increased risk for IV antimicrobial start. LIMITATIONS: Data for facility practices were self-reported and not patient specific. CONCLUSIONS: BHC was associated with higher risk for vascular access-related infection than RLC among in-center hemodialysis patients. Decisions regarding the use of BHC in dialysis centers should take into account the higher risk for infection. Studies are needed to evaluate infection control measures that may reduce infections related to BHC.

Practice, Practice, Practice! Effect of Resuscitative Endovascular Balloon Occlusion of the Aorta Volume on Outcomes: Data From the AAST AORTA Registry.

BACKGROUND: Resuscitative endovascular balloon occlusion of the aorta (REBOA) is an endovascular adjunct to hemorrhage control. Success relies on institutional support and focused training in arterial access. We hypothesized that hospitals with higher REBOA volumes will be more successful than low-volume hospitals at aortic occlusion with REBOA. METHODS: This is a retrospective study from the American Association for the Surgery of Trauma Aortic Occlusion for Resuscitation in Trauma and Acute Care Surgery Registry from November 2013 to January 2018. Patients aged ≥18 y who underwent REBOA were included. Successful placement of REBOA catheters (defined as hemodynamic improvement with balloon inflation) was compared between high-volume (≥80 cases; two hospitals), mid-volume (10-20 cases; four hospitals), and low-volume (<10 cases; 14 hospitals) hospitals, adjusting for patient factors. RESULTS: Of 271 patients from 20 hospitals, 210 patients (77.5%) had successful REBOA placement. Most patients were male (76.0%) and sustained blunt trauma (78.1%). cardiopulmonary resuscitation (CPR) was ongoing at the time of REBOA placement in 34.5% of patients. Inpatient mortality was 67.4%, unchanged by hospital volume. Multivariable logistic regression found increased odds of successful REBOA placement at high-volume versus low-volume hospitals (odds ratio [OR], 7.50; 95% confidence interval [CI], 2.10-27.29; P = 0.002) and mid-volume versus low-volume hospitals (OR, 7.82; 95% CI, 1.52-40.31; P = 0.014) and decreased odds among patients undergoing CPR during REBOA placement (OR, 0.10; 95% CI, 0.03-0.34; P < 0.001) when adjusting for age, sex, mechanism of injury, prehospital CPR, CPR on admission, transfer status, hospital location of REBOA placement, Glasgow Coma Scale ≤ 13, and injury severity. CONCLUSIONS: Hospitals with higher REBOA volumes were more likely to achieve hemodynamic improvement with REBOA inflation. However, mortality and complication rates were unchanged. Independent of hospital volume, ongoing CPR is associated with a decreased odds of successful REBOA placement.

Percutaneous AXillary Artery (PAXA) Access at the First Segment During Fenestrated and Branched Endovascular Aortic Procedures.

OBJECTIVE: The aim of this study was to assess the feasibility and safety of percutaneous axillary access with vessel closure device closure after puncturing the first segment during endovascular treatment of complex aneurysms with fenestrated and branched endografts (F/BEVAR). METHODS: The PAXA (Percutaneous AXillary Access) study is a physician initiated, single centre, ambispective, non-randomised study (clinicaltrials.gov: NCT03223311). The primary endpoint was the closure success rate defined as the absence of any vascular injury to achieve haemostasis at the puncture site, requiring any treatment other than manual compression or adjunctive endovascular ballooning. The secondary endpoints were minor access complications, cerebrovascular complication rate, short term access vessel patency, and study cohort anatomical evaluation of the axillary artery. RESULTS: Sixty-four patients required an upper extremity access during F/BEVAR procedure during study period (November 2016 to July 2019) and were screened for the PAXA study: 59 patients (47 males; median age: 75 years, IQR 69-78) met the study inclusion criteria and were enrolled (one patient had bilateral access). Closure success was obtained in 54 cases (90%) with no open conversion required: five patients received a bare or covered stenting to the AXA and in one patient mechanical failure of the delivery system was recorded. No 30 day permanent peripheral nerve injuries and two non-ipsilateral ischaemic strokes (3.4%) were recorded. Seven patients (12%) had access haematomas managed conservatively associated with closure failure (p = .002), oral anticoagulants therapy (p = .005) and procedure length (p = .028). At short term follow up (6 months), no late complications were observed, and all access vessels were patent. CONCLUSION: PAXA on the first segment using a large sheath (10-16F) is technically feasible, relatively safe with no need for open conversion but it may require access related secondary endovascular procedures. Further prospective studies are needed to modify the device instruction for use and to put the procedure on label.

Antistasis Retrograde Flow Vascular Catheter: A Novel Solution to Thrombogenicity: A Computational Fluid Dynamics Study.

BACKGROUND: Catheter-related thrombosis (CRT) is a serious complication of vascular catheters. Retrograde catheter insertion has been shown to decrease pericatheter hemostasis and thrombosis, but it is technically challenging. The current in silico trial is an analytical approach to evaluating different approaches to designing retrograde flow into a vascular catheter. METHODS: The novel catheter design aims to provide antistasis retrograde flow (ASRF) of fluid through multiple backward-directed side openings, with a self-closing terminal opening to facilitate standard insertion. Four different models of the catheter were evaluated by computational fluid dynamic studies, with retrograde-angled openings of 15°, 30°, 45°, and 60° to the long axis of the catheter. RESULTS: ASRF successfully reduced the areas of fluid stagnation in models with 15° and 30° openings. Models with 45° and 60° did not significantly reduce stagnation. ASRF is reversed by the main bloodstream after a few millimeters. The novel catheter design achieved a slightly higher saline flow rate compared with the standard catheter (89.75, 91.72, 94.13, and 94.26 mL/min for 15°, 30°, 45°, and 60° designs, respectively, versus 86.93 mL/min for the standard catheter). CONCLUSIONS: The novel ASRF vascular catheter reduces pericatheter fluid stasis and has the potential to reduce CRT. Further in vitro and in vivo trials are warranted to validate these findings and evaluate clinical efficacy.

Vascular access type and mortality in haemodialysis: a retrospective cohort study.

BACKGROUND: Haemodialysis patients have a high mortality rate. Part of this can be attributed to vascular access complications. Large retrospective studies have shown a higher mortality in patients dialysed with a catheter, which is mostly ascribed to infectious complications. Since we observe very little infectious complications in our haemodialysis patients, the aim of our study was to assess if we could still detect a difference in survival according to vascular access type. METHODS: Patients that started chronic haemodialysis treatment between 1/1/2007 and 31/12/2016 at the 'Universitair Ziekenhuis Brussel' were retrospectively studied. The time to death was studied as a function of the two main vascular access types using survival analysis, considering the type of vascular access at the initiation of dialysis or as time varying, and accounting for the available baseline characteristics. RESULTS: Of 374 patients 309 (82.6%) initiated haemodialysis with a catheter, while 65 patients initiated with an arteriovenous access. Vascular access type during follow-up did not change in 74% of all patients. A Kaplan Meier plot did not suggest a survival dependent on the vascular access type at start. An extended cox proportional hazard analysis showed that vascular access type was not independently correlated with mortality. However, age, history of congestive heart failure and active cancer at initiation of dialysis were independently associated with mortality. CONCLUSIONS: In this retrospective cohort study, haemodialysis vascular access type was not independently correlated with patient survival, even after taking into account change of vascular access over time.