Serial angiography and angioscopy of late lumen enlargement after drug-coated balloon for dysfunctional arteriovenous fistula.

The use of a drug-coated balloon (DCB) to treat dysfunctional arteriovenous fistula (AVF) has shown promising results. After percutaneous coronary intervention with DCB, late lumen enlargement (LLE) often develops in the early follow-up phase, but questions regarding the natural history of changes in lesions after DCB angioplasty have not been clearly elucidated. Here, we reported on a patient in whom angiography and angioscopy were performed immediately and 4 months after DCB angioplasty to treat cephalic vein stenosis of the dysfunctional AVF. Immediately after DCB application, angiography showed good dilatation and blood flow and mild vascular dissection that did not affect blood flow. Angioscopy showed that although the balloon had damaged the intima and the paclitaxel particles had adhered to the vessel wall. Four months after DCB treatment, follow-up angiography and angioscopy were performed. Angiography showed LLE in the cephalic vein of the AVF that had been treated by DCB angioplasty. Angioscopy showed that the intima of the vessel had almost completely healed, and the paclitaxel particles had disappeared. LLE might occur when DCB is used for AVF.

Pilot investigation of an electronic pillbox at a community opioid treatment program.

Background: Opioid treatment programs (OTPs) permit patients to ingest daily methadone doses unsupervised and away from the clinic, a strategy that enhances treatment access and convenience but has the potential for mismanagement.Objective: This retrospective review, conducted during the COVID-19 pandemic (5/2020-1/2022), evaluates the feasibility and acceptability of a commercially available electronic pillbox to safely administer methadone take-home tablets in a large community-based OTP (census >500 people).Methods: Study participants (n = 24; 54% male, 46% female; M age = 63 years) had recently received more take-homes per visit to support national social distancing directives, and were instructed that they could maintain these privileges by agreeing to use the pillbox.Results: Results demonstrate good demand feasibility as most participants (71%) agreed to use the pillbox. Good implementation feasibility was observed through safe and reliable delivery of most take-home tablets, with a staff support line to resolve technical issues. Acceptability was modest as six participants (25%) requested to return the pillbox despite losing some take-home privileges.Conclusion: Results support continued use and study of the electronic pillbox to safely deliver and increase access to methadone take-home doses.

Left ventricular assist devices: yesterday, today, and tomorrow.

The shortcomings of expense, power requirements, infection, durability, size, and blood trauma of current durable LVADs have been recognized for many years. The LVADs of tomorrow aspire to be fully implantable, durable, mitigate infectious risk, mimic the pulsatile nature of the native cardiac cycle, as well as minimize bleeding and thrombosis. Power draw, battery cycle lifespan and trans-cutaneous energy transmission remain barriers to completely implantable systems. Potential solutions include decreases in pump electrical draw, improving battery lifecycle technology and better trans-cutaneous energy transmission, potentially from Free-range Resonant Electrical Energy Delivery. In this review, we briefly discuss the history of LVADs and summarize the LVAD devices in the development pipeline seeking to address these issues.

Percutaneous interventional thrombectomy of an endovascular AV-fistula, a case report.

Dialysis access thrombosis is a common complication in the process of care. With the introduction of endovascular AV-fistulas [AVF]s the situation gained complexity with new potential thrombosis localizations. Several thrombectomy methods are available for recanalization of thrombosed AVFs ranging from invasive surgical methods to minimal invasive endovascular approaches. Early assessment, diagnosis and treatment is crucial for prolonging the life span of an AVF and preventing the need for placement of central venous catheters. To our best knowledge, we present the first case in which an obstructed antecubital communicating vein (aka perforating vein) of an endovascular created AVF was re-opened via interventional thrombectomy with the Rotarex® System (BD Interventional). The procedure was performed primarily under ultrasound guidance with fluoroscopic support. Our case report shows that this method, if done correctly and successfully, may prevent loss of the dialysis access. Additionally, we point towards the central role of ultrasound in this method.

Quality assurance in surgical trials of arteriovenous grafts for haemodialysis: A systematic review, a narrative exploration and expert recommendations.

BACKGROUND: Introducing new procedures and challenging established paradigms requires well-designed randomised controlled trials (RCT). However, RCT in surgery present unique challenges with much of treatment tailored to the individual patient circumstances, refined by experience and limited by organisational factors. There has been considerable debate over the outcomes of arteriovenous grafts (AVG) compared to AVF, but any differences may reflect differing practice and potential variability. It is essential, therefore, when considering an RCT of a novel surgical procedure or device that quality assurance (QA) is defined for both the new approach and the comparator. The aim of this systematic review was to evaluate the QA standards performed in RCT of AVG using a multi-national, multi-disciplinary approach and propose an approach for future RCT. METHOD: The methods of this have been previously registered (PROSPERO: CRD420234284280) and published. In summary, a four-stage review was performed: identification of RCT of AVG, initial review, multidisciplinary appraisal of QA methods and reconciliation. QA measures were sought in four areas - generic, credentialing, standardisation and monitoring, with data abstracted by a multi-national, multi-speciality review body. RESULTS: QA in RCT involving AVG in all four domains is highly variable, often sub-optimally described and has not improved over the past three decades. Few RCT established or defined a pre-RCT level of experience, none documented a pre-trial education programme, or had minimal standards of peri-operative management, no study had a defined pre-trial monitoring programme, and none assessed technical performance. CONCLUSION: QA in RCT is a relatively new area that is expanding to ensure evidence is reliable and reproducible. This review demonstrates that QA has not previously been detailed, but can be measured in surgical RCT of vascular access, and that a four-domain approach can easily be implemented into future RCT.

Risk factors for infection of totally implantable central venous access ports among patients requiring port removal.

BACKGROUND: Totally implantable central venous access ports, are required for various purposes, ranging from chemotherapy to nutrition. Port infection is a common complication. In many patients with port infection, the ports are removed because antibiotics are ineffective. We evaluated the risk factors associated with port removal due to port infection. METHODS: By retrospective chart review, we collected data of 223 patients who underwent port removal for any reason. Port infection was defined as infection symptoms, such as fever; elevated white blood cell counts or C-reactive protein levels; or redness at the port site, in the absence of other infections, which improved with port removal. The characteristics of patients with or without port infection were compared using univariate (chi-squared test, t-test) and multivariate logistic regression analyses. RESULTS: We compared 172 patients without port infection to 51 patients with port infection. Univariate analysis identified sex (p = 0.01), body mass index (BMI) ⩽20 kg/m2 (p = 0.00004), diabetes mellitus (p = 0.04), and purpose of use (p = 0.0000003) as significant variables. However, male sex (p = 0.03, 95% confidence interval [CI]: 0.01-0.23), BMI ⩽20 kg m2 (p = 0.002, 95% CI: 0.06-0.29), and purpose of use (total parenteral nutrition (TPN); p = 0.000005, 95% CI: 0.31-0.76) remained significant using multivariate analysis. Moreover, the patients with short bowel syndrome and difficulty in oral intake tended to be infected easily. Additionally, Staphylococcus species were the most common microbes involved in port infection. CONCLUSIONS: Male sex, BMI ⩽20 kg/m2, and purpose of use as a TPN were risk factors for port infection. Ports should not be used for long duration of TPN or used only in exceptional cases.

New Medical Device and Therapeutic Approvals in Otolaryngology: State of the Art Review of 2022.

Objective: To review new drugs and devices relevant to otolaryngology approved by the Food and Drug Administration (FDA) in 2022. Data Sources: Publicly available FDA data on drugs and devices approved in 2022. Review Methods: A preliminary screen was conducted to identify drugs and devices relevant to otolaryngology. A secondary screen by members of the American Academy of Otolaryngology-Head and Neck Surgery's (AAO-HNS) Medical Devices and Drugs Committee differentiated between minor updates and new approvals. The final list of drugs and devices was sent to members of each subspecialty for review and analysis. Conclusion: A total of 1251 devices and 37 drugs were identified on preliminary screening. Of these, 329 devices and 5 drugs were sent to subspecialists for further review, from which 37 devices and 2 novel drugs were selected for further analysis. The newly approved devices spanned all subspecialties within otolaryngology. Many of the newly approved devices aimed to enhance patient experience, including over-the-counter hearing aids, sleep monitoring devices, and refined CPAP devices. Other advances aimed to improve surgical access, convenience, or comfort in the operating room and clinic. Implications for Practice: Many new devices and drugs are approved each year to improve patient care and care delivery. By staying up to date with these advances, otolaryngologists can leverage new innovations to improve the safety and quality of care. Given the recent approval of these devices, further studies are needed to assess long-term impact within the field of otolaryngology.

Implanted blood vessel external support device for the treatment of distal hypoperfusion ischemic syndrome in arteriovenous fistulas and high-frame-rate Vector Flow quality assessment.

INTRODUCTION: Distal hypoperfusion ischemic syndrome (DHIS) is a complication occurring after arteriovenous fistula (AVF) creation. Different surgical alternatives haves been proposed in case of severe DHIS. Aim of the present paper is to present a new technique for DHIS treatment. MATERIAL AND METHODS: Between the 1st of January 2021 and the 31st December 2021 all the patients referred to our center for DHIS grade 2-4 were treated with a new surgical technique. It consists of AVF remodeling using an external nitinol support (VasQ®) to reduce the risk of outflow vein enlargement and DHIS recurrence. To better appreciate the hemodynamic effects of the surgery, a new ultrasound technique called high-frame-rate Vector Flow (HiFR-VF) was used. RESULTS: Seven patients (M:F 1:3; mean age 43 ± 12 years, range 29-65) were included in this study. Central line was never necessary, and technical success was 100% at 12 months. The comparison with historical data demonstrated lower recurrence of symptoms in comparison to simple artery-to-vein redo (p 0.50). The HiFR-VF showed flow with limited turbulent characteristics at the anastomosis site. DISCUSSION AND CONCLUSION: The new technique proposed demonstrated to be safe and effective for treatment of DHIS, preventing symptoms recurrence. Ultrasound examination and HiFR-VF can be considered a valuable method to evaluate complex flows at the levels of vascular anastomosis.

Robotic tomographic ultrasound and artificial intelligence for management of haemodialysis arteriovenous fistulae.

BACKGROUND: Arteriovenous fistulae (AVF) and Arteriovenous Grafts (AVG) may present a problematic vascular access for renal replacement therapy (RRT), reliant on recurrent specialist nurse and medical evaluation. Dysfunctional accesses are frequently referred 'out of the dialysis clinic' for specialist sonographic examination, with associated delays potentiating loss of vascular access viability and/or need for emergency intervention. Definitive anatomical and functional diagnostics based in the dialysis unit may help to solve these delays and associated complications. OBJECTIVES: This publication reports a novel vascular access monitoring concept, Robotic Tomographic Ultrasound (RTU). RESEARCH DESIGN: Robotic Tomographic Ultrasound incorporates a semi-autonomous, robotic vascular ultrasound system and purpose designed analysis software that can be deployed at the point of care. Three-dimensional scan data, as well as conventional B-Mode and Doppler data are obtained by the system and transferred to a cloud based reporting and analysis software. Scans are remotely annotated and interpreted by a sonographer, with diagnostic data presented securely to clinicians on their preferred web based application/web connected device. RESULTS: Software developed specifically for pre AVF mapping, maturation and monitoring protocols, analyse the data and then present interpreted results to all caring clinicians to assist with decision making. Vascular access planning can be determined with high confidence with data from the Map module. Maturation data can be presented in line with institutional requirements to the dialysis nurse, facilitating precocious needle access. CONCLUSION: Robotic Tomographic Ultrasound is a novel approach to vascular access management that may reduce the risk of loss of functional access by regular monitoring with the system; automated alerts guiding clinicians to the need for pre-emptive intervention, and the potential to increase longevity of the vascular access.

Early-cannulation arteriovenous grafts: Multidisciplinary learning is essential to optimize outcomes.

BACKGROUND: It is likely that there will be an increasing role for early-cannulation arteriovenous grafts (ecAVG) with a wider recognition of the need to tailor vascular access to avoid futile procedures and unnecessary TCVC. However, experience of these products is not common and limited to early surgical adopters, with little information on the systemic changes and multi-disciplinary care needed to optimize outcomes. The aim of this study was to report the impact of a multi-disciplinary approach on quantifiable outcomes. METHODS: A retrospective analysis of a prospectively maintained database of 295 ecAVG implanted over an 8-year time-period was performed. Indicative outcomes were chosen to reflect nephrology (patient selection), nursing care (cannulation complications of infection and pseudoaneurysm) and radiology (thrombosis) on cumulative impact (functional patency) over three distinct time periods. RESULTS: The incidence of ecAVG increased 10-fold over the three time periods. The use of ecAVG changed significantly from salvage tertiary access to TCVC avoidance and salvage of existing AVF. Nursing complications reduced markedly with significantly fewer over-cannulation episodes and pseudo-aneurysms. With an improved pro-active surveillance programme, the time to first thrombosis doubled and the risk of thrombosis halved. Ultimately this resulted in significantly improved functional patency with a risk of ecAVG loss less than one-third by the last time-period. CONCLUSIONS: All aspects of ecAVG use require scrutiny and critical appraisal. Failure or success is not simply achieved by performing good technical surgery with an efficacious product, but by the care taken across a wide range of elements spanning case selection, implantation, use and maintenance.

Performance of the 32 mm Myval transcatheter heart valve for treatment of aortic stenosis in patients with extremely large aortic annuli in real-world scenario: First global, multicenter experience.

BACKGROUND: Extremely large aortic valve anatomy is one of the remaining limitations leading to exclusion of patients for transcatheter aortic valve replacement (TAVR). AIMS: The newly approved Myval 32 mm device is designed for use in aortic annulus areas up to 840 mm2 . Here we want to share the initial worldwide experience with the device. METHODS AND RESULTS: Retrospective data were collected from 10 patients with aortic stenosis and very large annular anatomy (mean area 765.5 mm2 ), who underwent implantation with 32 mm Myval transcatheter heart valve at eight centers. Valve Academic Research Consortium-2 device success was achieved in all cases. Mild paravalvular leak was observed in three patients and two patients required new pacemaker implantation. One patient experienced retroperitoneal hemorrhage caused by the contralateral 6 F sheath and required surgical revision. No device-related complications, stroke, or death from any cause occurred within the 30-day follow-up period. In a studied cohort of 2219 consecutive TAVR-screened patients from a central European site, only 0.27% of patients showed larger anatomy than covered by the 32 mm Myval device by instructions for use without off-label use of overexpansion. This rate was significantly higher for the 34 mm Evolut Pro (1.8%) and 29 mm Sapien 3 (2.1%) devices. CONCLUSIONS: The Myval 32 mm prosthesis showed promising initial results in a cohort of patients who previously had to be excluded from TAVR. It is desirable that all future TAVR systems accommodate larger anatomy to allow optimal treatment of all patients.

Contrast removal from coronary sinus for prevention of contrast-induced nephropathy: a review.

The occurrence of contrast-induced-nephropathy (CIN) is related to the amount of contrast administration. Any removal of contrast from systemic circulation before reaching the kidneys might be beneficial using a device that removes contrast from a coronary sinus (CS). This manuscript aims to review the available literature regarding contrast removal from CS during coronary angiography or intervention for the prevention of CIN.

Optical detection of infiltration during peripheral intravenous infusion in neonates.

BACKGROUND: Infiltration and extravasation are common complications during peripheral intravenous infusion in the neonatal intensive care unit, and diagnosis is usually clinical, by inspection and palpation. Delay in diagnosis due to poor surveillance or misinterpretation of clinical signs may carry serious damage to the tissues of the neonate. Recently, a novel technology based on optical detection of infiltration has become available. METHODS: We have studied two groups of term and preterm infants receiving non-vesicant intravenous infusions by the peripheral route (24G short peripheral cannulas), and we evaluated the incidence of infiltration. In the first group, we have compared the clinical detection of infiltration versus the detection obtained by a novel optical device, blinding the alarms of the device. In the second group, the comparison was carried out without blinding the alarms. RESULTS: Of the neonates included in this study, 60% were female, 86% had a gestational age <37 weeks (34 ± 2.5 weeks) and a mean birth weight of 2.08 ± 0.4 g. Total recorded monitoring time was 1318 h and average monitoring time for each short peripheral cannula was 26.4 h. The incidence of infiltration was 80%, most of them having a Millam score <2. The novel device showed an overall sensitivity of 88.9% in detecting infiltration. Specificity was 84.4%, as evaluated assuming as standard the clinical diagnosis. Interestingly, in cases of documented infiltration, the event was diagnosed by the optical device approximately 6 h before the clinical diagnosis. CONCLUSIONS: Continuous monitoring of the insertion site, as automatically ensured by this novel optical device, may play a complementary role in early detection of infiltration, even if the percentage of false positives and false negatives suggests that periodic clinical assessment by expert nurses cannot be omitted.

Intrastent HeROgraft deployment as a catheter-sparing procedure.

Current vascular access (VA) practice adopts arteriovenous fistulas (AVF) as first option for haemodialysis, relegating arteriovenous grafts (AVG) for patients with exhausted upper limb venous patrimony. The Hemodialysis Reliable Outflow graft (HeRO®) is a device assuring direct venous outflow to the right atrium, thus avoiding central venous obstructive disease. Its use together with early access grafts avoids the need for central venous catheters (CVC) bridging periods. We report the deployment of the HeRO device using a previous stentgraft as pathway for the placement of the outflow component, in a patient with no-option for further autogenous upper limb access. This technique spared the usual central vein's exit point for the HeRO graft and, using an early-access dialysis graft, allowed for next-day successful haemodialysis.

Polymer-coated paclitaxel-eluting stents for the treatment of stenosed native arteriovenous fistulas: Long-term results from the ELUDIA study.

BACKGROUND: Percutaneous transluminal angioplasty is the preferred treatment of stenosed failing arteriovenous fistulas (AVF) but is hampered by increasing rates of vascular restenosis because of development of myointimal hyperplasia. METHODS: This multicenter observational study of polymer-coated low-dose paclitaxel-eluting stents (ELUvia stents by Boston Scientific) in stenosed AVF undergoing hemoDIAlysis (ELUDIA) was jointly conducted in three tertiary hospitals from Greece and Singapore. Failure of AVF was defined according to K-DOQI criteria and significant fistula stenosis (>50%DS by visual estimate) was determined with subtraction angiography. Patients were considered for ELUVIA stent insertion based on significant elastic recoil following balloon angioplasty for the treatment of a single vascular stenosis within a native AVF. The primary outcome measure was sustained long-term patency of the treated lesion/fistula circuit defined as successful stent placement with resumption of uninterrupted hemodialysis and without significant vascular restenosis (50%DS threshold) or other secondary interventions during follow-up. RESULTS: Some 23 patients received the ELUVIA paclitaxel-eluting stent (eight radiocephalic, 12 brachiocephalic, and three transposed brachiobasilic native AVFs). Mean AVF age at the time of failure was 33.9 ± 20.4 months. Treated lesions included 12 stenoses at the juxta-anastomotic segment, nine at the outflow veins, and two cephalic arch lesions with a mean diameter stenosis of 86 ± 8%. Median stent diameter and length used were 7 mm and 40 mm, respectively. After a median follow-up period of 20 months, some 18 stents out of 23 cases remained patent (cumulative rate 78.3%) without any clinical or imaging evidence of recurrent stenosis. Estimated primary patency of the ELUVIA stents was 80.6% and of the corresponding fistula circuit 65.1% at 2 years by Kaplan-Meier methods. CONCLUSIONS: This observational study has shown promising long-term results of polymer-coated paclitaxel-eluting stents for the treatment of failing arteriovenous fistulas. Large-scale controlled studies are necessary.

Suction thrombectomy of catheter-associated right atrial thrombus in two patients.

Catheter associated right atrial thrombus (CRAT) is an uncommon but potentially life-threatening condition. There are no established guidelines for management, and treatment ranges from systemic anticoagulation and thrombolysis to open surgery. While there have been reports on use of suction thrombectomy for right atrial thrombi, the feasibility and outcomes of suction thrombectomy in CRAT have not been described. These two cases describe a successful off-label use of two devices (Triever 20, Inari Medical, Irvine, CA, and AlphaVac, AngioDynamics, Latham, NY) for thrombectomy in CRAT. Both patients had near complete extraction of chronic appearing thrombus, with follow up imaging demonstrating complete resolution. Suction thrombectomy may have a unique role in management in CRAT, especially in cases of infected thrombi. A formal exemption from the institutional review board was obtained for publication.

Validation of the effectiveness of augmented reality-assisted vascular puncture: An experimental model.

PURPOSE: To demonstrate that the augmented reality-assisted puncture technique improves the efficacy of ultrasound-guided puncture to get central venous access (CVA), allows the image to be obtained without limitations, freeing the hands and keeping the gaze continuously on the working field, which contributes to improving the safety of the procedure. MATERIAL AND METHODS: A gelatin mould with a latex surface and a chicken breast with silicone tubes inside were used to simulate vascular punctures. Images were obtained by an ultrasound scanner and post-processed with a specific software. A hologram was obtained and projected onto the previously delimited surface to be punctured. The variables related to image acquisition, the characteristics of the structure to be cannulated and the percentage of successes in the first attempt were analysed. Six operators were involved, using different ultrasound scanners. Efficiency was examined after the application of technical improvements in the process. RESULTS: Seventy-six punctures were performed, guided by two different ultrasound scanners, divided into two groups: 37 with 33 successes (sigma = 3.52 with a process efficiency of 97.98%) and after technical improvements, 39 with 38 successes (sigma = 4.07 with a process efficiency of 99.4%). There are no significant differences among the operators (X2 p = 0.47) and between the ultrasound scanners (X2 p = 0.56). CONCLUSIONS: The augmented reality ultrasound-assisted CVA technique may be the next step in standardising the process of cannulation of vascular structures. This technique provides greater accuracy, greater comfort by freeing the hands and keeping the gaze on the working field, better ultrasound image quality, and eliminates variability between operators and sonographers.

Modified Seldinger technique for neonatal epicutaneo-caval catheter insertion: A non-randomised retrospective study.

BACKGROUND: Epicutaneo-Caval Catheters (ECCs) are critical for good neonatal care. No previous studies have evaluated which insertion method provides the highest likelihood of success. METHODS: This study aimed to compare the success rates and cost of modified Seldinger technique (MST) and split needle technique (SNT). MST was introduced to St Michael's Neonatal Unit, SNT was already in use. Routinely documented data on ECC insertion was retrospectively collected from the clinical notes. Practitioners were able to use their preferred insertion method. A sub-group analysis of success rates in patients born at ⩾35-weeks GA was performed. RESULTS: There was a significantly higher first pass (53% vs 26%; p = 0.014) and overall (72% vs 40%; p = 0.0046) successful ECC insertion rate with fewer venipunctures per successful ECC with MST (2.5 vs 6.5; p = 0.002). Logrank test demonstrated a significantly higher successful ECC insertion with MST for patients of all GA (p = 0.003) and for neonates born at ⩾35 weeks (p = 0.015). The cost per successful MST ECC was £156.41 versus £152.51 for SNT. CONCLUSION: In this uncontrolled retrospective study, there was a higher chance of successful ECC insertion with MST, with a reduced number of venipunctures and similar costs per successful ECC. Further work in randomised studies is needed to verify this finding and should focus on other clinical outcomes, including rates in central line associated blood stream infections.

Short midline catheters: High success rates for antibiotic therapy in children with cystic fibrosis.

OBJECTIVE: Short midline catheter use in paediatric populations appears to be increasing, however data on success rates and efficacy are sparse. This study aims to describe the success rate when midline venous catheters are employed as a single device for intravenous antibiotic therapy in paediatric patients with cystic fibrosis. METHODS: A retrospective cohort study was performed in a single institution, retrieving electronic medical record data from July 2017 through March 2020. The primary outcome was device success, defined as a catheter that remained functional until the end of antibiotic therapy. Reasons for device failure were categorized in a standard fashion. RESULTS: Primary outcome data were available for 116 catheter insertions, involving 49 patients and 55 proceduralists. The success rate was 84% (n = 98). Median age at insertion was 15 years (range 4-19) and median weight 52 kg (13-81). Soft, polyether block amide, Arrow® Seldinger Arterial Catheters were employed. Only 16 patients (14%) required general anaesthesia. Median time to failure was 6 days, and median time to successful completion of treatment was 13 days. Six of 18 failures occurred within 48 h and were likely insertion complications. The most common reasons for device failure were occlusion, extravasation, phlebitis and dislodgement. More than half of patients (56%) received antibiotic therapy at home. CONCLUSION: There is a high single device success rate when inserting short midlines for 13-day intravenous pulmonary antibiotic therapy in children with cystic fibrosis. These results should be confirmed with a prospective study.