Loop-tail stents fail in reducing stent-related symptoms: results of a prospective randomised controlled trial.

OBJECTIVE: To compare stent-related symptoms (SRS) of loop-tail (LT) and conventional double J (DJ) stents after uncomplicated flexible ureterorenoscopy (fURS), in a prospective randomised controlled single-blind parallel-group study. PATIENTS AND METHODS: Patients undergoing fURS were randomised into two groups: the LT Group received LT stents (Polaris™ Loop) and the DJ Group received conventional DJ stents (Vortek® ). The stent was removed after 4 weeks. The Ureteric Stent Symptom Questionnaire (USSQ) was administered at 2 days, 4 and 8 weeks (baseline evaluation) after stent insertion. The primary endpoint was to compare the Urinary Symptom Index Score of the LT vs DJ groups at 4 weeks after stent insertion. The secondary endpoints were to compare the USSQ domains' subscores at 2 days and 4 weeks after stent insertion, USSQ single answers at 4 weeks, and the 4-week USSQ domains' subscores adjusted for baseline. RESULTS: A total of 68 patients were randomised (34 LT and 34 DJ). The answers given at 4 weeks were not significantly different between the two groups for the Urinary Symptom Index Score (P = 0.982), Pain Index Score (P = 0.169), visual analogue scale (P = 0.276), and all the other domains of the USSQ. At 4 weeks, the single-answer analysis did not find any differences between the groups; the urinary symptoms were all comparable, as was the requirement for pain painkillers (P = 0.684) and pain during sex (P = 0.496). There were also no significant differences for every single domain score for the responses given at 2 days. The same applied to USSQ subscores at 4 weeks adjusted for the 8-week baseline results, which were also comparable. CONCLUSIONS: The study found no differences in terms of SRS between the LT and DJ groups, either at 2 days or 4 weeks after stent insertion, with or without baseline correction.

Twelve-month Durability of a Fully-implanted, Nickel-sized and Shaped Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome with Urgency Urinary Incontinence: A Single-Arm, Prospective Study.

OBJECTIVES: To evaluate the safety and efficacy of the eCoin - a nickel-sized, primary battery-powered, neuromodulation device for the treatment of urgency urinary incontinence which is implanted in the lower leg in a 20-minute procedure under local anesthesia. A feasibility clinical trial was conducted and the results after 1 year of treatment with the eCoin are presented. METHODS: A total of 46 participants with refractory urgency urinary incontinence were included in this prospective, single-arm, open-label study. This study was conducted at 7 sites in the United States and New Zealand. Participants in this study were implanted with the eCoin in the lower leg over the tibial nerve and activated after 4 weeks. Bladder diary data and validated quality-of-life instruments, collected at 3, 6, and 12 months' post-activation, were compared to baseline values. RESULTS: Responders were defined as those who had a ≥50% reduction in reported episodes of urgency urinary incontinence. At 12 months', 65% of participants were considered responders with 26% of participants achieving complete continence. The median number of urgency urinary incontinence episodes per day decreased from 4.2 at baseline to 1.7 at 12 months'. Seventy percent of participants reported feeling "better", "much better", or "very much better" on the Likert 7-point maximum scale. One participant experienced a related serious adverse event. CONCLUSION: The eCoin is a safe and effective treatment for urgency urinary incontinence associated with overactive bladder syndrome, with significant reduction or complete resolution of symptoms and no significant safety concerns.

Breast Textured Implants Determine Early T-helper Impairment: BIAL2.20 Study.

BACKGROUND/AIM: Surgical stress has been correlated with higher rate of postoperative complications. Breast implants' surfaces (textured or smooth) represent an immunological stimulus. Our prospective study (BIAL2.20) evaluated post-operative leukocytes response at baseline and postoperative day (POD) 1 and 2 after implant-based breast reconstruction. PATIENTS AND METHODS: Between January and July 2020, 41 patients underwent reconstruction with textured (n=23) or smooth (n=18) implants. A full blood count and lymphocyte subsets were collected before surgery, on POD1 and POD2. Data were evaluated as difference and relative difference from baseline by two-way analysis of variance test (2-way-ANOVA). Mann-Whitney U-test was performed at each POD, whenever between-group 2-way-ANOVA reached statistical significance. RESULTS: Within-group-analysis showed statistically significant total leukocytosis in both groups. Within-group-analysis of lymphocytes subsets demonstrated statistically significant lymphopenia in the textured group for T-lymphocytes, and T-helper cells. Between-group-analysis showed statistically significant lymphopenia in T-helper subsets in the textured group at POD1 and POD2, when compared with the smooth group. CONCLUSION: Textured implants demonstrated a statistically significant impairment of T-helper trend during POD1 and POD2 when compared to smooth implants by between-group 2-way-ANOVA.

Duodenoscope as a Vector for Transmission.

Elevator-based endoscope-related infections from patient cross-contamination is a multifactorial problem related to device design, maintenance, and function, with additional risk incurred from a high-level disinfection process that lacks quality controls. This article reviews the historical context for these outbreaks, technical aspects of scope design contributing to this risk, and innovations in endoscope technology that have the potential to overcome these shortcomings. Also reviewed are interim solutions and the data that support use of some of these interventions. Still needed are a validated manufacturer-recommended schedule for routine duodenoscope and echoendoscope maintenance with reprocessing protocols that can be implemented in endoscopy units.

Recent Actions by the US Food and Drug Administration: Reducing the Risk of Infection from Reprocessed Duodenoscopes.

In addition to technological advancements, engagement and collaboration among the wider community of stakeholders will be beneficial toward reducing the risk of infection from reprocessed duodenoscopes. Such a community can raise awareness of the importance of duodenoscope cleaning, work to improve reprocessing training, identify the most pressing unanswered questions that merit further research, and develop tools that can be used by health care facilities to improve the quality of reprocessing at their sites. The Food and Drug Administration looks forward to working with the community to further reduce the risk of infections from reprocessed duodenoscopes.

Unexpected Obstruction of a Parker Flex-Tip Endotracheal Tube Caused by Outward Bending of Its Tip: A Case Report.

We report a case of Parker Flex-Tip endotracheal tube obstruction caused by its tip bending outward against the tube lumen. The Parker Flex-Tip tube tip is designed to bend inward to prevent damage to airway structures during intubation. However, when its tip is bent outward, the tube aperture is distorted, shifts against the tracheal wall, and is occluded. Moreover, the cross-sectional area of the openings on the side of the endotracheal tube, the "Murphy's eyes" which are ellipses, decrease because the openings are pulled parallel to their long axis. Outward bending of the tip can obstruct the tube.

Flexible versus rigid laryngoscopy: A randomized crossover study comparing patient experience.

OBJECTIVES: To compare flexible distal-chip laryngoscopy (FDL) versus rigid telescopic laryngoscopy (RTL) in regard to examinees' pain level, comfort, satisfaction, and preference, and to evaluate the clinician's assessment of the examinees' experience with both exam types. STUDY DESIGN: Randomized crossover study. METHODS: Twenty-three normal adult subjects were recruited to undergo both FDL and RTL; the initial exam type was randomized. Subjects and clinicians completed corresponding questionnaires after each exam. Differences in participant characteristics and questionnaire scores between the two exam types were assessed via Pearson χ2 and paired t tests, respectively. RESULTS: Overall, participants reported that FDL was more uncomfortable than RTL (4.22 vs. 2.91, P = .003) and scored higher on the pain scale for FDL compared to RTL (2.91 vs. 1.70, P = .006). However, there was no significant difference in number of participants who preferred FDL versus RTL (10 [43%] vs. 13 [57%]). Poor correlation was seen between clinicians' assessment of participants' discomfort and actual reported discomfort for FDL (2.70 vs. 4.22, P = .001). CONCLUSIONS: Subjects undergoing FDL experience greater discomfort and pain compared to RTL, but do not demonstrate a differential preference of exam. Overall, clinicians underestimate the discomfort of patients undergoing FDL, but participants maintain high satisfaction with both exams nonetheless. LEVEL OF EVIDENCE: 1 Laryngoscope, 130:2663-2666, 2020.

Noise-induced hearing loss in the military dental setting: a UK legislative perspective.

INTRODUCTION: Health professionals working in the dental environment are potentially at risk of noise-induced hearing loss (NIHL) due to the use of clinical and laboratory equipment. Workplaces engaging in the practice of dentistry within the UK are subject to legislation from the Control of Noise at Work (CNW) regulations 2005. Clinicians working in the military are at further increased risk of NIHL due to exposure from additional risk factors such as rifles or aircraft engines. To our knowledge, no authors have previously studied the noise levels experienced in a military dental setting or compared noise levels in a typical dental practice with current UK legislation. METHOD: Measurements of noise levels experienced by a dentist, dental nurse and dental hygienist during a standard conservation procedure were assessed using wearable noise dose-badges. Furthermore, noise levels within a dental technician's work space were also assessed. Noise levels produced by representative clinical and laboratory equipment were assessed and compared with CNW legislation. RESULTS: The highest level for clinical equipment was produced by the suction apparatus while aspirating up a cup of water at 76 dB. For laboratory equipment, the lower exposure action value (LEAV) of 80 dB would be exceeded in 2.1 hours' use of the trimmer, 3.6 hours' use of the vibrating table and 9 min use of the airline. CONCLUSIONS: Noise levels experienced by clinicians within the dental surgery were well below the legislative LEAV thresholds for both peak and continuous noise. However, noise levels produced by laboratory equipment were far higher and there is clearly the potential for excessive noise exposure for dental professional in the everyday setting. Dental professionals responsible for dental laboratory settings must be familiar with the CNW regulations and measures put in place that control the inadvertent breach of legislation. Hearing protection must be mandated when using equipment that exceeds the LEAV and an educational programme is required to explain both their correct use and the rationale behind it. Methods of mitigating that risk further require exploration such as alternative methods of completing the tasks performed by the airline or reducing the noise generated by it, such as by reducing the supply pressure or using an alternative nozzle design.

Relationship between pancreatic thickness and staple height is relevant to the occurrence of pancreatic fistula after distal pancreatectomy.

BACKGROUND: A triple-row stapler is widely used to divide the pancreas in distal pancreatectomy (DP). However, the selection criteria of the stapler cartridge to prevent postoperative pancreatic fistula (POPF) remain unclear. The objective of this study was to determine if factors concerning pancreatic thickness or staple size affect POPF after DP. METHODS: Datasets of patients from the Mayo Clinic and National Cancer Center Hospital East who underwent DP using a triple-row stapler were merged. Risk of POPF was analyzed using clinicopathological variables, including data for pancreatic thickness and staple height. A compression index was defined as the designated staple height (mm) after closure divided by the pancreatic thickness (mm). RESULTS: Among the 277 patients, POPF occurred in 65 (23%) patients. The median pancreatic thickness was 13.7 mm and the median compression index was 0.137. Multivariable logistic models showed that a greater pancreatic thickness (odds ratio, 1.190, P < 0.001) and a compression index ≤0.160 (odds ratio, 4.754, P < 0.001) were independently related with POPF. CONCLUSION: In patients undergoing DP using a triple-row stapler, the thickness of the pancreas was related with the occurrence of POPF. Selection of the stapler cartridge with a compression index of ≤0.160 may reduce the occurrence of POPF.

Is Watson for Oncology per se Unreasonably Dangerous?: Making A Case for How to Prove Products Liability Based on a Flawed Artificial Intelligence Design.

Artificial intelligence (AI) machines hold the world's curiosity captive. Futuristic television shows like West World are set in desert lands against pink sunsets where sleek, autonomous AI fulfill every human need, desire, and kink. But I, Robot, a movie where robots turn against the humans they serve, reminds us that AI is precarious. Academicians who study how AI interacts with tort law, such as Jessica Allain, David Vladeck, and Sjur Dyrkoltbotn, claim that the current legal regime is incapable of addressing the liability issues AI present. Both Allain and Vladeck focus their research on whether tort law can accommodate claims against fully autonomous AI machines, while Dyrkoltbotn explores how AI can be leveraged to help plaintiffs identify the genesis of their injuries. The solution this article presents is not exclusively tailored to fully autonomous AI and does not identify how technology can be used in tort claims. It instead demonstrates that the current tort law regime can provide relief to plaintiffs who are injured by AI machines. In particular, this article argues that the manner in which Watson for Oncology is designed presents a new context in which courts should adopt a per se rule of liability that favors plaintiffs who bring damage claims against AI machines by expanding the definition of what it means for a device to be unreasonably dangerous.

Effectiveness and safety of transvenous extraction of single- versus dual-coil implantable cardioverter-defibrillator leads at single-center experience.

The available literature lacks data concerning direct comparison of the effectiveness and safety of single- versus dual-coil implantable cardioverter-defibrillator (ICD) leads transvenous extraction. Certainly, additional shocking coil in superior vena cava adds to the amount of metal in the vascular system. Adhesions developing around the superior vena cava coil add to the difficulty of extraction of ICD lead if lead removal is required. The aim of the study was to assess the effectiveness and safety of single- and dual-coil ICD leads transvenous extraction using mechanical systems. We performed transvenous lead extraction (TLE) of 197 ICD leads in 196 patients. There were 46 (23.3%) dual-coil leads removed from 46 (23.5%) patients. Cardiovascular implantable electronic device-related infection was an indication for TLE in 25.0% of patients. The following extracting techniques were used: manual direct traction, mechanical telescopic sheaths, controlled-rotation mechanical sheaths, and femoral approach. Complete ICD lead removal and complete procedural success in both groups were similar (99.3% in single-coil vs 97.8% in dual-coil, P = .41 and 99.3% in single-coil vs 97.8% in dual-coil, P = 0.41, respectively). We did not find significant difference between major and minor complication rates in both groups (2.0% in single-coil vs 4.3% in dual-coil, and 0.7% in single-coil vs 0.0% in dual-coil, P = .58, respectively). There was 1 death associated with the TLE procedure of single-coil lead.This study shows that extraction of dual-coil leads seems to be comparably safe and effective to extraction of single-coil leads. On the other hand, it requires longer fluoroscopy time and frequent utilization of advanced tools.

Safety and Efficacy of Endoscopically Secured Fully Covered Self-Expandable Metallic Stents (FCSEMS) for Post-Bariatric Complex Stenosis.

BACKGROUND: The use of fully covered self-expandable metallic stents (FCSEMS) has opened the door to treat stenosis in the post-bariatric stomach. We hypothesized that endoscopically securing a FCSEMS would be technically feasible, effective, and safe for > 30-day dwell time. OBJECTIVES: To assess the technical feasibility, clinical efficacy, and safety of endoscopically secured FCSEMS in the stomach for > 30 days. METHODS: A retrospective review (September 2016 to April 2018) of consecutive patients who underwent FCSEMS suturing in the stomach at a single academic institution was reviewed. Technical success, stent dwell time, symptoms, and adverse events were recorded. RESULTS: Fifteen patients (median age of 49 (31-70)) were included. Stents were inserted for gastrojejunal (GJ) stricture or gastric stenosis in 9/15 and 6/15 of patients, respectively. All procedures were technically successful (100%). Immediate and short-term clinical success (prior to stent removal) was 100% in patients who did not have stent migration. Stent migration was seen in 3 cases (20%) after a median dwell time of 211 days. However, 2/3 (66.6%) had not attended their scheduled removal. Recurrence of symptoms after stent removal was seen in 53.3% of patients with 40% undergoing repeat stenting. Median stent dwell was 117 (30-342) days. Sixty percent and 33% of patients had stent dwell of at least 90 and 180 days, respectively. CONCLUSIONS: A FCSEMS, if secured, may be safe and effective for even > 90-day dwell time in the post-bariatric stomach and may result in long-term clinical success for GJ stricture after stent removal.

The Impact of Circular Stapler Size on the Incidence of Cervical Anastomotic Stricture After Esophagectomy.

BACKGROUND: Cervical anastomotic stricture after esophagectomy is a serious complication that adversely affects postoperative recovery, nutritional status and quality of life. Cervical anastomosis by a circular stapler (CS) has been widely accepted as a simple and convenient method, but anastomotic strictures are likely to occur. The aim of this study was to investigate an association between CS size and the incidence of anastomotic stricture after cervical esophagogastric anastomosis performed by a CS. METHODS: Between April 2011 and March 2016, 236 consecutive patients underwent cervical esophagogastric anastomosis by a CS via a retrosternal route after esophagectomy for esophageal cancer. These patients were divided into according to CS size for the procedure as follows: small-sized (25 mm) CS group (SG, n = 116) and large-sized (28 or 29 mm) CS group (LG, n = 120). The clinical data of patients were analyzed retrospectively to compare the two groups. RESULTS: Overall, anastomotic strictures were observed in 90 patients (38%). The incidence of anastomotic stricture was significantly lower in the LG than the SG (23% vs. 53%, p < 0.001) (Table 3). Chronic obstructive pulmonary disease (COPD: FEV1.0% <70%) (OR 2.35, 95% CI = 1.09-5.14; p = 0.029), anastomotic leakage (OR 8.97, 95% CI = 2.69-41.30; p < 0.001), and a small-sized CS (OR 3.42, 95% CI = 1.82-6.62; p < 0.001) were independent risk factors for anastomotic stricture in the multivariate analysis. CONCLUSIONS: If possible, a large-sized CS should be used to prevent cervical anastomotic strictures when performing cervical anastomoses by CS.

A novel self-expanding biflanged metal stent vs tubular metal stent for EUS-guided transmural drainage of pancreatic pseudocyst: A retrospective, cohort study.

Although endoscopic ultrasound (EUS)-guided transmural drainage of pancreatic fluid collections with metal stents is generally preferred over plastic stents, its superiority among different types of metal stents has not yet been well studied. We conducted this study to compare clinical outcomes and complications of a novel self-expanding biflanged metal stent (BFMS) and a traditional-shaped tubular metal stent (TMS) in treating pancreatic pseudocyst (PPC).This was a retrospective analysis on consecutive patients with PPC underwent EUS-guided transmural drainage with either TMS or BFMS in a single tertiary center with expertise in management of complex biliary and pancreatic problems. The technical and functional success rate, reintervention, complications, and recurrence rate were evaluated.From September 2013 to January 2018, 125 patients (66.4% male, median age 47 years) underwent EUS-guided transmural drainage for PPC. Among them, 49 used TMS and 76 used BFMS. All patients met the inclusion criteria that cyst diameter was >6 cm or the distance between cyst and stomach wall was shorter than 1 cm. There was no difference in technical success (98% vs 97.4%, P = 1.0) or functional success rate (87.8% vs 92.1%, P = .54) using 2 types of metal stents. However, more procedure related complications occurred in TMS than in BFMS group. TMS group had a much higher migration rate than BFMS group (14.6% vs 0, P = .001), even though there was no significant difference in bleeding, infection, or death rate between 2 groups. With similar clinical outcomes, TMS group required more additional plastic stent placement than BFMS group for better drainage.TMS and BFMS placement can both be considered as methods of endoscopic transmural PPC drainage with equal efficacy, whereas BFMS could be preferred for fewer complications or less need of additional plastic stent placement.

A Comparison of Two Designs of Postoperative Shoe on Function, Satisfaction, and Back Pain After Hallux Valgus Surgery.

Background. The reverse camber shoe is commonly used after hallux valgus corrective surgery to offload the forefoot but is associated with back pain and poor compliance. Recent designs of postoperative shoes may obviate the need for a reverse camber. The purpose of this study was to compare the effects of a reverse camber shoe and a noncambered shoe with transitional rigidity after hallux valgus correction. Methods. A cohort of 80 feet was prospectively studied undergoing surgery at a single NHS trust. The first 40 feet received the reverse cambered Jura Medical Off-loader Heel shoe and the subsequent 40 feet received the noncambered DonJoy Podalux shoe. No demographic differences existed between the groups and data were collected at 2 weeks, 6 weeks, and 6 months. The Manchester-Oxford Foot Questionnaire (MOXFQ), a 5-question survey and dichotomous question about back pain was used to assess clinical outcome and radiographs were reviewed by 2 orthopaedic surgeons to monitor for loss of correction. Results. Both groups experienced comparable improvements in MOXFQ and shoe satisfaction from 2 weeks compared with 6 weeks. Six patients experienced back pain in the reverse cambered shoe group and none in the noncambered shoe group. Five patients stopped using the reverse cambered shoe during the first 6 weeks after surgery and none stopped using their prescribed noncambered shoe. No loss of corrections were observed in either group. Conclusion. Both shoe designs gave equal foot specific functional and radiological outcomes, but the noncambered shoe with transitional rigidity was associated with less back pain and better compliance. Levels of Evidence: Level II: Prospective comparative study.

A Comparison between the i-gel® and air-Q® Supraglottic Airway Devices Used for the Patients Undergoing General Anesthesia with Muscle Relaxation.

OBJECTIVES: The aim of the present study was to compare two supraglottic airway (SGA) devices (i.e., the i-gel® © Intersurgical Ltd and air-Q® (Reusable) Cookgas company) in terms of the insertion time, amount of leak during ventilation with maximum positive pressure, and postoperative complications in patients referring to Modarres Hospital in Tehran. METHOD: The present double-blind clinical trial was performed on 60 patients undergoing elective surgeries that required general anesthesia with muscle relaxation. Patients were randomly assigned to either i-gel® (n = 30) or Air-Q® (n = 30) groups. RESULTS: The mean age, body mass index, duration of surgery, duration of anesthesia, and gender ratio were not significantly different between the two groups. Mean ± SD values of the SGA devices' insertion time (in seconds) in the air-Q® and i-gel® groups were 4.87 ± 1.6 and 6.80 ± 1.2, respectively (P < 0.001). The mean OLP in the Air-Q® group was significantly higher than that of the i-gel® group (35.9 ± 9.6 versus 24.8 ± 3.7, p < 0.001). The frequency of complications occurred after the supraglottic airway insertion was higher in the i-gel® group. However, only in terms of sore throat, the difference between the two groups was statistically significant: 6 (20%) had sore throat (P = 0.024) in the i-gel groups, but in in the Air-Q® groups no one had this side effect after surgery. CONCLUSION: It was concluded that the Air-Q® supraglottic airway was placed faster and easier with fewer complications than the i-gel in general anesthesia with muscle relaxation. The frequency of the occurrence of all three complications, cough, sore throat, and blood, on the cuff (6 (20%) was higher in the i-gel group than that in the air-Q® group (cough3 (10%), sore throat 0 (0%), and blood on the cuff 3 (10%) (P < 0.05).

Early-BYRD: alternative early pacing and defibrillation lead replacement avoiding venous puncture.

BACKGROUND: In cases of lead failure after implantation of pacemakers (PM) or implantable cardioverter defibrillators (ICD) early lead replacement may be challenging. Puncture of the subclavian vein bears possible complications such as pneumothorax, hematothorax, and damage of leads to be left in place. To avoid venous puncture PM or ICD leads were replaced using a flexible polypropylene sheath (Byrd-sheath). METHOD: From January 2010 through December 2017, 55 patients underwent early lead exchange avoiding venous puncture. Early lead exchange for this study was defined as a reintervention within 14 days after the initial lead implantation. The connector of the malfunctioning lead was cut off, and stabilized by a stiff stylet. After having cut off the plastic knob of the stylet, the lead was passed through the polypropylene sheath and the latter advanced into the subclavian vein with gentle rotational movements to gain access to the subclavian vein. After lead removal the polypropylene sheath was replaced by a peel away sheath a new lead inserted. RESULTS: Overall, 23 defibrillation leads and 34 pacing leads (16 right atrial leads, 17 right ventricular leads, and 1 left ventricular lead) were successfully explanted. Access to the subclavian vein was uneventful, and blood loss minimal. Radiation exposure and fluoroscopy time were also negligible. CONCLUSION: The Byrd-sheath technique proved to be safe and successful in providing vein access within 2 weeks after initial lead implantation using the previously implanted lead and thus avoiding puncture of the subclavian vein.