Sirolimus-coated Eustachian tube balloon dilatation for treating Eustachian tube dysfunction in a rat model.

Eustachian tube balloon dilatation (ETBD) has shown promising results in the treatment of ET dysfunction (ETD); however, recurrent symptoms after ETBD frequently occur in patients with refractory ETD. The excessive pressure of balloon catheter during ETBD may induce the tissue hyperplasia and fibrotic changes around the injured mucosa. Sirolimus (SRL), an antiproliferative agent, inhibits tissue proliferation. An SRL-coated balloon catheter was fabricated using an ultrasonic spray coating technique with a coating solution composed of SRL, purified shellac, and vitamin E. This study aimed to investigate effectiveness of ETBD with a SRL-coated balloon catheter to prevent tissue proliferation in the rat ET after ETBD. In 21 Sprague-Dawley rats, the left ET was randomly divided into the control (drug-free ETBD; n = 9) and the SRL (n = 9) groups. All rats were sacrificed for histological examination immediately after and at 1 and 4 weeks after ETBD. Three rats were used to represent the normal ET. The SRL-coated ETBD significantly suppressed tissue proliferation caused by mechanical injuries compared with the control group. ETBD with SRL-coated balloon catheter was effective and safe to maintain ET luminal patency without tissue proliferation at the site of mechanical injuries for 4 weeks in a rat ET model.

Effects of Extracorporeal Membrane Oxygenation on the Coagulation System.

This study aimed to investigate the effects of long-term awake extracorporeal membrane oxygenation (ECMO) on the coagulation system in a sheep model. A total of ten healthy sheep were included in the study, with 5 sheep in each group. In the veno-arterial ECMO (V-A ECMO) group, cannulation was performed in the right carotid artery and the right external jugular vein. In the veno-venous ECMO (V-V ECMO) group, a dual-lumen catheter was utilized to insert into the right external jugular vein. After initiating ECMO, the sheep were recovered from anesthesia and remained awake for 7 days. The target activated clotting time (ACT) goal was set at 220-250 s. In both groups, the actual ACT fluctuated around 250 s with the dose of heparin gradually increasing, reaching almost 60 IU/kg/min at the end of the experiments. Moreover, the activated partial thromboplastin time (APTT) and thrombin time (TT) values were significantly higher in the V-A ECMO group compared to the V-V ECMO group, despite receiving the same doses of heparin. Although laboratory test results fluctuated within a normal and reasonable range, infarct foci in the kidneys were observed in both groups at the end of the study.

A technique for repeated blood and cerebrospinal fluid sampling from individual rats over time without the need for repeated anesthesia.

Ethical animal use follows the 3R's: Replacement, Reduction and Refinement. Here, we present the use of simultaneous jugular vein and cisterna magna catheterization via a port system in rats for repeated fluid sampling for 14 consecutive days without loss of catheter patency. This technique allows repeated intra-animal sampling without anesthesia and, if used with pooling samples from a cohort of animals, replaces the need for terminal collections for sufficient sample volumes.

Morphology of the papilla can predict procedural safety and efficacy of ERCP-a systematic review and meta-analysis.

Endoscopic Retrograde Cholangiopancreatography (ERCP) is the primary therapeutic procedure for pancreaticobiliary disorders, and studies highlighted the impact of papilla anatomy on its efficacy and safety. Our objective was to quantify the influence of papilla morphology on ERCP outcomes. We systematically searched three medical databases in September 2022, focusing on studies detailing the cannulation process or the rate of adverse events in the context of papilla morphology. The Haraldsson classification served as the primary system for papilla morphology, and a pooled event rate with a 95% confidence interval was calculated as the effect size measure. Out of 17 eligible studies, 14 were included in the quantitative synthesis. In studies using the Haraldsson classification, the rate of difficult cannulation was the lowest in type I papilla (26%), while the highest one was observed in the case of type IV papilla (41%). For post-ERCP pancreatitis, the event rate was the highest in type II papilla (11%) and the lowest in type I and III papilla (6-6%). No significant difference was observed in the cannulation failure and post-ERCP bleeding event rates between the papilla types. In conclusion, certain papilla morphologies are associated with a higher rate of difficult cannulation and post-ERCP pancreatitis.

Indicación, realización y resultado del cateterismo de venas adrenales en pacientes con hiperaldosteronismo primario / Indication, performance and outcomes of adrenal vein sampling in patients with primary hyperaldosteronism

El hiperaldosteronismo primario (HAP) es una causa importante de hipertensión arterial (HTA) secundaria. El estudio del mismo precisa de una alta sospecha clínica, además de un estudio hormonal que confirme la hipersecreción hormonal. Es importante iniciar el tratamiento adecuado una vez se confirma el diagnóstico, y para ello es preciso demostrar si la hipersecreción hormonal es unilateral (pacientes que podrían ser tributarios a tratamiento quirúrgico) o bilateral (pacientes que son tributarios a tratamiento únicamente farmacológico). En el Hospital del Mar desde el año 2016 existe un equipo de trabajo multidisciplinar en el que participan nefrólogos, endocrinólogos, radiólogos y cirujanos para evaluar los casos con sospecha de hiperaldosteronismo y consensuar el mejor abordaje diagnóstico-terapéutico de estos pacientes, incluyendo la necesidad de cateterismo venoso adrenal, que es una técnica que en los últimos años se ha erigido como gold standard para el estudio del HAP. En el presente estudio recogemos la experiencia de nuestro centro en la realización de cateterismo venoso adrenal y en la utilidad de este para el manejo de tales pacientes (AU)

Primary hyperaldosteronism (PAH) is an important cause of secondary hypertension (HTN). The study of the same requires a high clinical suspicion in addition to a hormonal study that confirms hormonal hypersecretion. It is important to start the appropriate treatment once the diagnosis is confirmed, and for this is necessary to demonstrate whether the hormonal hypersecretion is unilateral (patients who could be candidates for surgical treatment) or bilateral (patients who are candidates for pharmacological treatment only). At the Hospital del Mar since 2016 there has been a multidisciplinary work team in which Nephrologists, Endocrinologists, Radiologists and Surgeons participate to evaluate cases with suspected hyperaldosteronism and agree on the best diagnostic-therapeutic approach for these patients, including the need for adrenal vein sampling, which is a technique that in recent years has become the gold standard for the study of PAH. In the present study we collect the experience of our center in performing adrenal vein catheterization and its usefulness for the management of these patients (AU)

Tratamiento intervencionista de la embolia aguda de pulmón: resultados de un registro multicéntrico / Catheter-directed therapy for acute pulmonary embolism: results of a multicenter national registry

Introduction and objectives Catheter-directed therapy (CDT) for acute pulmonary embolism (PE) is an emerging therapy that combines heterogeneous techniques. The aim of the study was to provide a nationwide contemporary snapshot of clinical practice and CDT-related outcomes. Methods This Investigator-initiated multicenter registry aimed to include consecutive patients with intermediate-high risk (IHR) or high-risk (HR), acute PE eligible for CDT. The primary outcome of the study was in-hospital all-cause death. Results A total of 253 patients were included, of whom 93 (36.8%) had HR-PE, and 160 (63.2%) had IHR-PE with a mean age of 62.3±15.1 years. Local thrombolysis was performed in 70.8% and aspiration thrombectomy in 51.8%, with 23.3% of patients receiving both. However, aspiration thrombectomy was favored in the HR-PE cohort (80.6% vs 35%; P<.001). Only 51 patients (20.2%) underwent CDT with specific PE devices. The success rate for CDT was 90.9% (98.1% of IHR-PE patients vs 78.5% of HR-PE patients, P<.001). In-hospital mortality was 15.5%, and was highly concentrated in the HR-PE patients (37.6%) and significantly lower in IHR-PE patients (2.5%), P<.001. Long-term (24-month) mortality was 40.2% in HR-PE patients vs 8.2% in IHR-PE patients (P<.001). Conclusions Despite the high success rate for CDT, in-hospital mortality in HR-PE is still high (37.6%) compared with very low IHR-PE mortality (2.5%) (AU)

Introducción y objetivos El emergente tratamiento por catéter (TPC) de la embolia pulmonar (EP) aguda combina técnicas heterogéneas. El objetivo del estudio es describir la práctica clínica contemporánea y los resultados relacionados con la TPC en un registro de ámbito nacional. Métodos Registro multicéntrico iniciado por investigador, destinado a incluir a pacientes con EP aguda consecutivos y en riesgo intermedio-alto (IAR) o alto riesgo (AR) elegibles para TPC. El resultado primario del estudio fue la muerte por cualquier causa en el hospital. Resultados Se incluyó en total a 253 pacientes, 93 (36,8%) con EP-AR y 160 (63,2%) con EP-IAR, de una media de edad de 62,3±15,1. Se realizó trombolisis local al 70,8% de los pacientes, trombectomía aspirativa al 51,8% y ambas al 23,3%. Sin embargo, la trombectomía por aspiración fue más frecuente en la cohorte de EP-AR (el 80,6 frente al 35%; p<0,001). Solo 51 pacientes (20,2%) se sometieron a TPC con dispositivos específicos de EP. El éxito de la TPC fue del 90,9% (el 98,1% de los casos de EP-IAR frente al 78,5% de los de EP-AR; p<0,001). La mortalidad hospitalaria fue del 15,5%, muy concentrada en los casos de EP-AR (37,6%) y significativamente menor entre los de EP-IAR (2,5%; p<0,001). La mortalidad a largo plazo (24 meses) fue del 40,2 en EP-AR frente al 8,2% en EP-IAR (p<0,001). Conclusiones A pesar del elevado éxito de la TPC, la mortalidad hospitalaria por EP-AR sigue siendo alta (37,6%) respeto a la muy baja mortalidad de la EP-IAR (2,5%) (AU)

Anatomic Variations of Foramen Ovale as a Predictor of Successful Cannulation in Percutaneous Trigeminal Rhizotomies.

BACKGROUND AND OBJECTIVES: Percutaneous trigeminal rhizotomies are common treatment modalities for medically refractory trigeminal neuralgia (TN). Failure of these procedures is frequently due to surgical inability to cannulate the foramen ovale (FO) and is thought to be due to variations in anatomy. The purpose of this study is to characterize the relationships between anatomic features surrounding FO and investigate the association between anatomic morphology and successful cannulation of FO in patients undergoing percutaneous trigeminal rhizotomy. METHODS: A retrospective analysis was conducted of all patients undergoing percutaneous trigeminal rhizotomy for TN at our academic center between January 1, 2010, and July 31, 2022. Preoperative 1-mm thin-cut computed tomography head imaging was accessed to perform measurements surrounding the FO, including inlet width, outlet width, interforaminal distance (a representation of the lateral extent of FO along the middle fossa), and sella-sphenoid angle (a representation of the coronal slope of FO). Mann-Whitney U tests assessed the difference in measurements for patients who succeeded and failed cannulation. RESULTS: Among 37 patients who met inclusion criteria, 34 (91.9%) successfully underwent cannulation. Successful cannulation was associated with larger inlet widths (median = 5.87 vs 3.67 mm, U = 6.0, P = .006), larger outlet widths (median = 7.13 vs 5.10 mm, U = 14.0, P = .040), and smaller sella-sphenoid angles (median = 52.00° vs 111.00°, U = 0.0, P < .001). Interforaminal distances were not associated with the ability to cannulate FO surgically. CONCLUSION: We have identified morphological characteristics associated with successful cannulation in percutaneous rhizotomies for TN. Preoperative imaging may optimize surgical technique and predict cannulation failure.

Umbilical vein catheterisation for the family physician working in primary health care.

This is part of a series of articles on vascular access in emergencies. The other two articles were on intra osseous lines and central venous lines. These are critical lifesaving emergency skills for the primary care professional. In this article, we will provide an overview of umbilical vein catheterisation highlighting its importance, the indications, contraindications, techniques, complications and nursing considerations. By familiarising healthcare providers with this procedure, we hope to enhance their knowledge and skills, ultimately leading to improved outcomes in the neonatal population.

Endoscopic Management of Difficult Biliary Stones: An Evergreen Issue.

Choledocholithiasis is one of the most common indications for endoscopic retrograde cholangiopancreatography (ERCP) in daily practice. Although the majority of stones are small and can be easily removed in a single endoscopy session, approximately 10-15% of patients have complex biliary stones, requiring additional procedures for an optimum clinical outcome. A plethora of endoscopic methods is available for the removal of difficult biliary stones, including papillary large balloon dilation, mechanical lithotripsy, and electrohydraulic and laser lithotripsy. In-depth knowledge of these techniques and the emerging literature on them is required to yield the most optimal therapeutic effects. This narrative review aims to describe the definition of difficult bile duct stones based on certain characteristics and streamline their endoscopic retrieval using various modalities to achieve higher clearance rates.

Effect of two different techniques of arteriovenous fistula puncture on wound infection in haemodialysis patients.

Safe and effective arteriovenous fistula (AVF) puncture is very important to reduce the wound complications of haemodialysis (HD). For AVF puncture in dialysis patients, there is a lack of clarity and consistency regarding the relative advantage of buttonhole (BH) over rope-ladder (RL) cannulae in terms of wound complications. The study was published in several scientific databases including Cochrane Library, PubMed and Embase by October 2023. Data from all controlled trials looking at the effect of BH and RL on wound complications in haemodialysis patients were included. The articles were written in English, and they were about adult who had AVF while on dialysis. Studies with or without BH or RL treatment were excluded from the analysis. The data was analysed with RevMan5.3 software. Out of 215 trials, 9 were chosen for the final analysis. The study publication dates were between 2000 and 2023. Of these, 17 326 patients received AVF therapy. Among them, there were 3070 BH and 14 256 RL. In 9 studies, RL had a lower risk of postoperative wound infection compared to BH (OR, 3.38; 95% CI, 3.06, 3.73 p < 0.0001); In all 3 studies, there were no statistically significant differences in the risk of post operative bleeding in RL versus BH(OR, 0.76; 95% CI, 0.25, 2.33 p = 0.63). Our studies have demonstrated that RL trocars are superior to BH trocars in the prevention of wound infection.

Applying Tension to the Transcervical Foley Balloon and Delivery Times in Term Nulliparous Women Undergoing Induction of Labor: A Randomized Controlled Trial.

OBJECTIVE: To investigate the effects of applying tension to a transcervical Foley balloon on delivery time in term nulliparous patients undergoing labor induction. METHODS: This cluster randomized clinical trial included 279 term nulliparous women presenting for labor induction with a plan for cervical ripening through transcervical Foley balloon placement. Participants were assigned to either the tension group (n=138) or the no-tension group (n=141) on the basis of randomized, weekly clusters (26 total clusters). The primary outcome measured was the time from initial Foley balloon insertion to delivery. Secondary outcomes included cesarean delivery rates, peripartum infection, and neonatal intensive care unit (NICU) admission. Our prior data suggested that delivery time in the tension group would be about 1,053 minutes. We estimated a sample size of 260 (130 per group, 26 clusters) on the basis of a 25% difference, power of 80%, and two-sided α of 0.05. RESULTS: A total of 279 term nulliparous patients were included in the analysis. The median time from Foley placement to delivery was 1,596 minutes (range 430-3,438 minutes) for the tension group and 1,621 minutes (range 488-3,323 minutes) for the no-tension group ( P =.8); similar results were noted for time to vaginal delivery. No significant differences were observed in the secondary outcomes, including the rates of cesarean delivery (34.1% vs 29.8%, P =.7), peripartum infection, and NICU admission, between the two groups. CONCLUSION: Applying tension to a transcervical Foley balloon in term nulliparous women undergoing labor induction did not significantly reduce delivery time or improve secondary outcomes. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov , NCT05404776.

Analysis of adverse events related to extracorporeal membrane oxygenation from a nationwide database of patient-safety accidents in Japan.

Although adverse events related to extracorporeal membrane oxygenation have been reported, epidemiological data on life-threatening events are insufficient to study the causes of such adverse events. Data from the Japan Council for Quality Health Care database were retrospectively analyzed. The adverse events extracted from this national database included events associated with extracorporeal membrane oxygenation reported between January 2010 and December 2021. We identified 178 adverse events related to extracorporeal membrane oxygenation. At least 41 (23%) and 47 (26%) accidents resulted in death and residual disability, respectively. The most common adverse events were cannula malposition (28%), decannulation (19%), and bleeding (15%). Among patients with cannula malposition, 38% did not undergo fluoroscopy-guided or ultrasound-guided cannulation, 54% required surgical treatment, and 18% required trans-arterial embolization. In this epidemiological study in Japan, 23% of the adverse events related to extracorporeal membrane oxygenation had fatal outcomes. Our findings suggest that a training system for cannulation techniques may be needed, and hospitals offering extracorporeal membrane oxygenation should perform emergency surgeries.

Cannulation rates and technical performance evaluation of commericially available single-use duodenoscopes for endoscopic retrograde cholangiopancreatography: A systematic review and meta-analysis.

BACKGROUND: Single use duodenoscopes were developed to reduce the risk of infection transmission from contaminated reusable duodenoscopes. To this end, we examined various biliary interventions using single use duodenoscopes in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP). METHODS: Medline, Embase, Scopus, and Cochrane databases were searched from inception through Aug 2022 to identify studies reporting on the performance of single use duodenoscopes for ERCP. RESULTS: Seven articles were included in the final analysis that included 642 patients (318 males). The Exalt Model D duodenoscope was used in most cases (88.8%) followed by the aScope Duodeno (11.2%) for ERCP. Most ERCPs had a complexity grade of 2 (n = 303) and 3 (n = 198). The pooled cumulative rate of successful cannulation was 95% (95% Confidence Interval (CI): 93-96%, I2=0%, P = 0.46). Sphincterotomy was successfully performed in all cases. The pooled cumulative rate of PEP was 2% (95% CI: 0.4-3.4%, I2=0%, P = 0.80). The pooled cumulative rate of total adverse events was 7% (95% CI: 4-10%, I2=47%, P = 0.08). CONCLUSIONS: The results of this systematic review and meta-analysis show that single use duodenoscopes are associated with high cannulation rates, technical performance, and safety profile.

Refinement of intrathecal catheter design to enhance neuraxial distribution.

BACKGROUND: Delivery of therapeutics via indwelling intrathecal catheters is highly efficacious for targeting of pain, spasticity, neuraxial cancer and neurodegenerative disorders. However, current catheter designs have some major limitations. Given limited CSF flow, fixed intrathecal volume and the large distance of the rostro-caudal spinal axis, current intrathecal delivery routes fail to achieve adequate drug distribution. Additionally open catheter systems are plagued with cellular ingrowth and debris accumulation if used intermittently. NEW METHOD: RESULTS/COMPARISON WITH EXISTING METHOD(S): High speed imaging showed micro-valve catheters greatly increase fluid exit velocities compared to typical open-ended catheters, which prevents pooling of injectate proximal to the opening. When implanted intrathecally in rats, small injection volumes (7.5 µL) of dye or AAV9-RFP, resulted in an even rostro-caudal distribution along the spinal axis and robust transfection of neurons from cervical to lumbar dorsal root ganglia. In contrast, such injections with an open-ended catheter resulted in localized distribution and transfection proximal to the delivery site. Our poly micro-valve catheter design resulted in equivalent transfection rates of cervical DRG neurons using 100x lower titer of AAV9-RFP. Unlike open port catheters, no debris accumulation was observed in the lumen of implanted catheters, showing potential for long-term intermittent use. CONCLUSIONS: This catheter platform, suitable for small animal models is easily scalable for human use and addresses many of the problems observed with common catheter systems.

SAGES peritoneal dialysis access guideline update 2023.

BACKGROUND: Minimally invasive surgery has been used for both de novo insertion and salvage of peritoneal dialysis (PD) catheters. Advanced laparoscopic, basic laparoscopic, open, and image-guided techniques have evolved as the most popular techniques. The aim of this guideline was to develop evidence-based guidelines that support surgeons, patients, and other physicians in decisions on minimally invasive peritoneal dialysis access and the salvage of malfunctioning catheters in both adults and children. METHODS: A guidelines committee panel of the Society of American Gastrointestinal and Endoscopic Surgeons reviewed the literature since the prior guideline was published in 2014 and developed seven key questions in adults and four in children. After a systematic review of the literature, by the panel, evidence-based recommendations were formulated using the Grading of Recommendations Assessment, Development and Evaluation approach. Recommendations for future research were also proposed. RESULTS: After systematic review, data extraction, and evidence to decision meetings, the panel agreed on twelve recommendations for the peri-operative performance of laparoscopic peritoneal dialysis access surgery and management of catheter dysfunction. CONCLUSIONS: In the adult population, conditional recommendations were made in favor of: staged hernia repair followed by PD catheter insertion over simultaneous and traditional start over urgent start of PD when medically possible. Furthermore, the panel suggested advanced laparoscopic insertion techniques rather than basic laparoscopic techniques or open insertion. Conditional recommendations were made for either advanced laparoscopic or image-guided percutaneous insertion and for either nonoperative or operative salvage. A recommendation could not be made regarding concomitant clean-contaminated surgery in adults. In the pediatric population, conditional recommendations were made for either traditional or urgent start of PD, concomitant clean or clean-contaminated surgery and PD catheter placement rather than staged, and advanced laparoscopic placement rather than basic or open insertion.

Efficacy and safety of removing peritoneal dialysis catheters using the pull technique.

PURPOSE: To study the efficacy and safety of peritoneal dialysis (PD) catheter removal using the pull technique. METHODS: We conducted a retrospective analysis of 36 patients in whom the pull technique was used to remove a PD catheter. We evaluated the efficacy, safety, and health economic benefits of this technique by analyzing the pain score, duration of the procedure, complications during or after the procedure, and cost. RESULTS: The mean age (± standard deviation) of the 36 patients was 51 ± 14 years involving 27 males and 9 females with a mean body mass index was 23.4 ± 2.6. The mean duration of PD was 28 months (range 4-96 months). The site of the pull technique for peritoneal dialysis catheter removal was at the bedside or in the treatment room, with local anesthesia or no anesthesia. The mean duration of the procedure (from anesthesia to complete removal of the PD catheter) was 5-15 min. Only one patient experienced catheter rupture and no patients developed procedural or post-procedural bleeding or abdominal wall leakage. Infection did not occur at the inner or outer cuffs, tunnel, or outlet. Pain scores analyzed by a 10-point visual analogue scoring technique both immediately and 24 h after the procedure were 3.5 ± 1.7 and 1.2 ± 0.8, respectively. CONCLUSIONS: The pull technique is simple to perform, takes a short time, results in few complications and small wounds, causes only mild pain, enables fast recovery, and results in low medical costs.

Development and assessment of novel assist device for cardiac cannulation.

PURPOSE: Congenital heart defects are the most common birth defects in the USA and in 25% of cases need to be treated with cardiovascular interventions. One of such interventions is the postoperative use of an extracorporeal membrane oxygenation (ECMO) machine for the treatment of cardiorespiratory failure. The process of placing the patient on the ECMO is extremely time-critical and requires the use of cardiac cannulation. For the first time, our team developed and evaluated a new quick-connect cannulation system that allows for rapid, easy, and safe ECMO cannulation in the pediatric population. The design should eliminate the need for purse-string sutures that are currently used to secure cannulas, as the cannulas will be inserted through a port that is glued to the cardiovascular tissue. METHODS: The rapid cannulation assistance device was designed on the SolidWorks computer-aided design software using the dimensions of the commercially available arterial and venous catheters. These designs were then 3D printed, and tensile testing was performed. Then, a flow loop was developed, and cannulation was performed and analyzed on both 3D-printed hearts and porcine hearts. RESULTS: The rapid cannulation assistance device was designed and 3D printed. Tensile testing found that the parts were strong enough to withstand forces that may be introduced in studies. 3D-printed and porcine heart tests with a flow loop found no leakage with the 3D-printed hearts but minimal leaking with the porcine hearts. However, this leakage was observed at the junction between the device and the heart, leading us to believe that a glue better suited to attach the device to the heart would prevent leakage in the future. CONCLUSIONS: This project successfully demonstrated how a rapid cannulation assistance device could be developed and tested. Future studies will be conducted that address device adhesion to the cardiovascular tissue so that accurate pressure and flow rates can be measured. Future studies will also include testing the device in a fluid environment to more effectively analyze the device success and comparing the time required to cannulate using our device compared to the standard of care.