Use of double-layered covered esophageal stents in post-surgical esophageal leaks and esophageal perforation: Our experience. / Uso de prótesis esofágicas cubiertas de doble malla en fístulas esofágicas postquirúrgicas y perforaciones esofágicas: experiencia en nuestro centro.

INTRODUCTION: The use of esophageal stents for the endoscopic management of esophageal leaks and perforations has become a usual procedure. One of its limitations is its high migration rate. To solve this incovenience, the double-layered covered esophageal stents have become an option. OBJECTIVES: To analyse our daily practice according to the usage of double-layered covered esophageal metal stents (DLCEMS) (Niti S™ DOUBLE™ Esophageal Metal Stent Model) among patients diagnosed of esophageal leak or perforation. METHODS: Retrospective, descriptive and unicentric study, with inclusion of patients diagnosed of esophageal leak or perforation, from November 2010 until October 2018. The main aim is to evaluate the efficacy of DLCEMS, in terms of primary success and technical success. The secondary aim is to evaluate their (the DLCEMS) safety profile. RESULTS: Thirty-one patients were firstly included. Among those, 8 were excluded due to mortality not related to the procedure. Following stent placement, technical success was reached in 100% of the cases, and primary success, in 75% (n=17). Among the complications, stent migration was present in 21.7% of the patients (n=5), in whom the incident was solved by endoscopic means. CONCLUSIONS: According to our findings, DLCEMS represent an alternative for esophageal leak and perforation management, with a high success rate in leak and perforation resolutions and low complication rate, in contrast to the published data. The whole number of migrations were corrected by endoscopic replacement, without the need of a new stent or surgery.

Is the French Paradox cementing philosophy superior to the standard cementing? A randomized controlled radiostereometric trial and comparative analysis.

AIMS: Highly polished stems with force-closed design have shown satisfactory clinical results despite being related to relatively high early migration. It has been suggested that the minimal thickness of cement mantles surrounding the femoral stem should be 2 mm to 4 mm to avoid aseptic loosening. The line-to-line cementing technique of the femoral stem, designed to achieve stem press-fit, challenges this opinion. We compared the migration of a highly polished stem with force-closed design by standard and line-to-line cementing to investigate whether differences in early migration of the stems occur in a clinical study. METHODS: In this single-blind, randomized controlled, clinical radiostereometric analysis (RSA) study, the migration pattern of the cemented Corail hip stem was compared between line-to-line and standard cementing in 48 arthroplasties. The primary outcome measure was femoral stem migration in terms of rotation and translation around and along with the X-, Y-, and Z- axes measured using model-based RSA at three, 12, and 24 months. A linear mixed-effects model was used for statistical analysis. RESULTS: Results from mixed model analyses revealed a lower mean retroversion for line-to-line (0.72° (95% confidence interval (CI) 0.38° to 1.07°; p < 0.001), but no significant differences in subsidence between the techniques (-0.15 mm (95% CI -0.53 to 0.227; p = 0.429) at 24 months. Radiolucent lines measuring < 2 mm wide were found in three and five arthroplasties cemented by the standard and line-to-line method, respectively. CONCLUSION: The cemented Corail stem with a force-closed design seems to settle earlier and better with the line-to-line cementing method, although for subsidence the difference was not significant. However, the lower rate of migration into retroversion may reduce the wear and cement deformation, contributing to good long-term fixation and implant survival. Cite this article: Bone Joint J 2022;104-B(1):19-26.

What Is the Impact of Postoperative Antibiotic Prophylaxis on Tissue Expander Infection Rates in Pediatric Patients?

BACKGROUND: Tissue expansion in the pediatric population can be complicated by high rates of infection and extrusion. The aim of this study was to examine the impact of postoperative antibiotic prophylaxis on infectious complications. METHODS: A retrospective study of all pediatric patients who underwent tissue expander insertion at a children's hospital over a 12-year period was performed. Predictor variables included age, sex, race, indication, anatomical location, number of expanders inserted, serial expansion, history of infection or extrusion, and postoperative antibiotics. Outcome variables included infection and extrusion. Bivariate and multivariate analyses were performed to identify factors associated with infection and/or extrusion. RESULTS: A total of 180 patients who underwent 317 operations for tissue expander insertion were included in this study. Postoperative infection and/or extrusion occurred after 73 operations (23 percent). Postoperative prophylactic antibiotics were prescribed after 232 operations (75 percent), and only perioperative (≤24 hours) antibiotics were administered in 85 cases (25 percent). There were no significant differences in the rate of infection (12.1 percent versus 8.9 percent; p = 0.46), extrusion (16.8 percent versus 17.7 percent; p = 0.88), or infection and/or extrusion (23.7 percent versus 24.1 percent; p = 0.95) between these two groups. Multivariate analysis revealed that postoperative antibiotics did not have a significant association with infection and/or extrusion (OR, 0.84; 95 percent CI, 0.44 to 1.63; p = 0.61). CONCLUSIONS: The rates of infection/extrusion were similar between pediatric patients who received only perioperative antibiotics (≤24 hours) and those who were prescribed a course of postoperative antibiotics. Based on these results, a course of postoperative prophylactic antibiotics may be unnecessary after insertion of tissue expanders in pediatric patients. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Polymer based endografts have improved rates of proximal aortic neck dilatation and migration.

BACKGROUND: Proximal aortic neck dilatation (PND) affects a considerable proportion of patients undergoing endovascular aneurysm repair (EVAR) and is associated with increased rates of type I endoleak (EL1), migration, and reinterventions. Although there are numerous studies investigating PND following the placement of endografts that utilize self-expanding stent (SES) technology, there are few reports for patients treated with endografts that utilize polymer-filled rings. The purpose of this study is to examine PND and graft migration after EVAR with the Ovation stent graft. METHODS: The study comprised patients who underwent EVAR as part of the prospective, international, multicenter Ovation stent graft trial. A clinical events committee adjudicated adverse events through 1 year, an independent imaging core laboratory analyzed imaging through 5 years, and a data safety and monitoring board provided study oversight. Neck diameter was measured at the level of the lowest renal artery. PND was defined as neck enlargement of 3 mm or more. Graft migration was defined as distal movement >10 mm or movement ≤10 mm when resulting in secondary intervention. RESULTS: A total of 238 patients received this device during the study period. Patients were predominantly male (81%), with a mean age of 73 ± 8 years. Median follow-up was 58 months (IQR 36-60). Almost half the patients (110 patients, 46%) had challenging anatomy; defined as outside the instructions for use (IFU) with other commercially available stent grafts. 41 patients (17.2%) had a proximal neck length <10 mm and 93 (39%) had a minimum access vessel diameter <6 mm. The technical success rate was 100%. The 1-, 3- and 5-year overall survival rates were 96.6%, 86.2% and 74.9%, respectively. The immediate postoperative proximal neck diameter ranged from 16 mm to 31 mm with a mean of 22.4 ± 3 mm. During follow-up, ten patients (4.2%) developed PND. Freedom from PND estimates at 1, 3 and 5 years were 97.7%, 96%, and 93.6%, respectively. None of the patients developed endograft migration. CONCLUSIONS: The use of the Ovation stent graft was associated with low rates of PND despite challenging neck anatomy in 17% of patients. No graft migration was observed. The design of this endograft may explain its superiority to SES in preventing neck dilatation and migration even in patients with challenging neck anatomy. This is important, as we continue to see significant late failures of EVAR due to proximal neck degeneration.

Lead Migration in Neuromodulation.

We describe a simple technique of securing surgically implanted leads for spinal cord (SCS), dorsal root ganglion (DRG) and occipital nerve stimulation (ONS), for both primary surgical implantation and correcting lead migration. This technique could also be adapted for securing percutaneously implanted leads. Thirty-nine patients underwent neurosurgical implantation of SCS, DRG, and ONS devices utilizing titanium mini-plates to obtain secure anchorage of leads to adjacent laminae close to their exit point from the epidural space, thereby minimizing the risk of further lead migration or electrode displacement. There were no cases of primary or recurrent lead migration in any patient undergoing lead placement using mini-plate anchorage. The technique appears to offer a reliable means of preventing post-operative lead migration in a variety of spinal and extra-cranial neuromodulation implants.

Association between different peritoneal dialysis catheter placement methods and short-term postoperative complications.

BACKGROUND: Considering that current peritoneal dialysis has its own shortcomings, In this study, the Seldinger technique was modified to explore the relationship between different catheter placement methods of peritoneal dialysis and short-term postoperative complications. METHODS: We retrospectively analyzed the data of 157 patients who received peritoneal dialysis in the Department of Nephrology of our hospital from January 2017 to December 2019. According to different catheter placement methods, the patients were divided into three groups: 111 cases of open surgery technique, 23 cases of Seldinger technique, and 23 cases of modified Seldinger technique (ultrasound-guided Veress needle puncture). The general data, laboratory indexes, and abdominal infection and catheter-related complications within one month postoperatively were collected. RESULTS: There were 48 (31.0 %) cases of complications in 157 patients within one month postoperatively, which were mainly catheter-related complications (45 cases, 29.0 %). The incidence of catheter tip peritoneal drift (catheter migration) in the three groups was 27.3 %, 39.1 %, and 9.1 %, respectively, with no significant difference between groups (P = 0.069). Univariate logistic regression analysis showed that the systolic blood pressure, history of abdominal and pelvic surgery, creatinine, and modified Seldinger technique were possible impact factors of catheter migration (P < 0.10). After fully adjusting for confounding factors, Compared with the open surgery group, the modified Seldinger method group significantly reduced the risk of catheter migration with an OR of 0.161 (95 % confidence interval: 0.027-0.961, P = 0.045); However, the difference between the Seldinger method group and the open surgery group was not significant, with an OR of 1.061 (95 % confidence interval: 0.308-3.649, P = 0.926). Curve fitting showed that the average incidence of catheter migration in the three groups was 27.3 % (95% CI: 15.9-42.7 %), 28.5 % (95% CI: 10.7-56.9 %), and 5.7 % (95% CI: 1.0-27.0 %); the modified Seldinger method has the lowest average incidence of catheter migration. CONCLUSIONS: Modified Seldinger technique can significantly reduce catheter-related short-term complications after peritoneal dialysis, and it is especially effective in reducing the incidence of catheter migration. Modified Seldinger technique is a safe and feasible method for the placement of a peritoneal dialysis catheter.

Endograft platform does not influence aortic neck dilatation after infrarenal endovascular aneurysm repair with primary endostapling.

OBJECTIVES: Aortic endografts used for endovascular aneurysm repair (EVAR) are based on varying skeletal platforms such as stainless steel or nitinol stents, using radial force applied to seal at the aneurysm neck, and varying proximal fixation methods, applying either suprarenal or infrarenal fixation. This study assesses whether varying skeleton/fixation platforms affect neck-related outcomes after primary endostapling with Heli-FX EndoAnchors at EVAR. METHODS: Retrospective analysis of a prospective database of infrarenal EVAR undertaken at a single centre. Chimney-EVAR, secondary cases were excluded. Primary outcomes analysed included neck diameter evolution from pre-EVAR to latest imaging follow-up, including a comparison of stent platforms to see if there was any outcome difference between those using stainless steel or nitinol, as also freedom from type I endoleakage and migration. Secondary outcomes assessed included average number of EndoAnchors, and sac size patterns before and after EVAR. RESULTS: A total of 101 patients underwent endostapled infrarenal EVAR between September 2013 and March 2020. After exclusion of ineligible patients, 84 patients (76 male, 8 female, age 73.7 ± 7.8 years) were available for analysis. 57/27 endografts used suprarenal/infrarenal fixation, whilst 16/68 devices were based on stainless steel/nitinol platforms, respectively. Mean oversizing was higher for stainless steel/suprarenal fixation endografts (p = 0.02). A total of 582 EndoAnchors were deployed, averaging 7 ± 2 per patient. Median neck diameter was 25 mm (IQR 22-31) with 22 necks having non-parallel morphology (conical, tapered or bubble). Median follow-up period was 28.5 (IQR 12-43) months. Neck evolution studies suggested aortic neck dilatation of 5 ± 4 mm (p <0.001, paired T-test), independent of platforms employed (p = NS, ANOVA). There was no endograft migration; one immediate post-EVAR endoleak settled by eight weeks. There was a mean 5.7 ± 8.2 mm sac size reduction (p < 0.001, paired T-test). CONCLUSION: Aortic neck dilatation occurs after EVAR with primary endostapling, but the process may be independent of stainless steel/nitinol platforms, possibly due to the attenuating effect of EndoAnchors. Adjunct aneurysm neck fixation by primary endostapling prevents migration regardless of whether suprarenal/infrarenal fixation is the primary fixative method. Device platform choice therefore may be left to the operator discretion if primary endostapling is applied at EVAR. Freedom from complications such as migration and endoleakage in the intermediate term suggests a higher level of 'tolerance' to aortic neck dilatation with primary endostapling. We would therefore suggest routine usage of EndoAnchors at EVAR when not otherwise contraindicated.

Ectopic origin of bronchial arteries: still a potential pitfall in embolization.

PURPOSE: To evaluate the influence of ectopic origin of bronchial arteries (BAs) on bronchial artery embolization (BAE) for hemoptysis. METHODS: CT and angiography images of 50 consecutive sessions in 39 patients (aged 26-93 years; mean, 70.6 years) who underwent BAE for hemoptysis from April 2010 to December 2019 were reviewed. We defined ectopic BA as a systemic artery originating from other than the T5-T6 vertebral level of the descending aorta with course along the major bronchi. The background of patients, number of BAs, culprit arteries, and treatment outcomes were compared between the cases with and without ectopic BAs. RESULTS: Seventeen patients (43.6%) demonstrated 19 ectopic BAs, originating from the subclavian artery (n = 7), aortic arch above the T5-T6 level (n = 6), internal mammary artery (n = 3), brachiocephalic trunk (n = 2) or lower descending thoracic aorta (n = 1). Total number of BAs in the cases with ectopic BA was significantly greater than those in cases without ectopic BA (p = 0.0062). Required sessions of embolization were similar in the two groups. No procedure-related significant complications were noted; however, four ectopic BAs caused unexpected filling of contrast media or migration of the embolic material from the orthotopic BA to ectopic BA originating from the arch vessels via tiny communication. CONCLUSION: Although BAE under the presence of ectopic BA is feasible and safe, detection of BAs with ectopic origin, even of small diameter, is needed to avoid risk of non-target coursing of embolic materials.

An observational study of the securement of central venous access devices with a subcutaneous anchor device in a paediatric population at a tertiary level hospital.

Paediatric central venous access devices are associated with significant complications. Failure rates have been estimated to be as high as 25%, with securement failure a significant contributing factor. In this study, we evaluate the use of a subcutaneous securement device, securAcathTM, in minimising rates of central venous access device dislodgement and unintended early removal within a paediatric population. Data were collected on 52 consecutive paediatric patients, aged less than 18 years old, who required peripherally inserted central catheters and non-cuffed tunnelled centrally inserted central catheters. We found that the rate of securement failure with securAcathTM was 2.01 per 1000 catheter days. This compared to 2.58 in our previous practice without securAcathTM. With the use of securAcathTM, no securement failures were observed in our patients with non-cuffed tunnelled centrally inserted central catheters. There were three instances of securement failure in patients with peripherally inserted central catheters. We conclude that the use of a securAcathTM fixation device in central venous access devices is an effective method of securement, especially in use with non-cuffed tunneled centrally inserted central catheters. However, when significant tension is applied to the central venous access devices migration is still possible.

Assessment of Pull-out Forces in TEVAR and ANACONDA FEVAR Combination and Early Clinical Results: Creation of a Proximal Landing Zone for FEVAR in Patients with Extent I and Extent IV TAAAs.

BACKGROUND: Although recent data on the treatment of thoracoabdominal aortic aneurysms (TAAAs) are promising, in some cases, the paravisceral segment of the aorta may not be suitable for a branched endograft due to space restrictions. A combination of a fenestrated aneurysm repair (FEVAR) with a thoracic aneurysm repair (TEVAR) may represent a feasible treatment option. The current investigation was performed to assess the stability of a fenestrated Anaconda device implanted into a set of thoracic endografts from different manufacturers. We then assessed our clinical results with the FEVAR/TEVAR combination. METHODS: Pull-out forces were measured in vitro after docking a fenestrated Anaconda graft within the distal end of different TEVAR devices. Anaconda devices were implanted in 28- or 30-mm thoracic tube grafts (oversizing of at least 2 mm: 13.3-21.4; minimum overlap of 15 mm). Continuously increasing longitudinal pull forces of up to 100 N were applied on an Instron Tensile Tester. Initial break point and damage to the endografts were documented. Clinical results of patients treated with such an FEVAR/TEVAR combination at our institution are presented as a second part of this study. RESULTS: Median pull-out forces ranged from 2.38 N to 55.0 N. The highest stability was achieved with 34-mm Anaconda devices in 28-mm thoracic tube grafts. Grafts with either thinner Dacron material or those featuring a polytetrafluorethylene membrane seemed especially vulnerable to punctures and tears caused by the downward-looking hooks of the Anaconda device. Between April 1, 2013 and December 31, 2018, in 28 of 172 patients treated with a fenestrated Anaconda device, prior implantation of a thoracic tube graft was necessary to create a sufficient proximal landing zone. In 25 cases (89.3%), the aneurysm was successfully treated. Although the 30-day reintervention rate in this subgroup was relatively high at 28.6%, none of these was due to a failure of the FEVAR/TEVAR combination. Upon an average follow-up of 15 months, no failure of the graft connection and no type III endoleak due to membrane damage were observed. CONCLUSIONS: The combination of a thoracic tube graft and a fenestrated Anaconda device is a viable option for the treatment of patients with Extent I or IV TAAAs with no adequate landing zone above the celiac trunk. Although pull-out testing has shown good stability with most assessed grafts, the thoracic devices with thicker Dacron membranes seemed to be especially suitable.

An innovative cyanoacrylate device developed to improve the current standard of care for intravascular catheter securement.

INTRODUCTION: Over one billion intravascular devices are used worldwide, annually. Due to the associated complications with these devices, the development of a reliable yet cost-effective securement technique is extremely important. The purpose of this study is to demonstrate the strength of a novel catheter securement cyanoacrylate for securing peripheral venous catheters, central venous catheters, peripherally inserted central catheters, and all other intravascular catheter types. MATERIALS AND METHODS: An unprecedented in vitro method was performed to quantify and compare the strength of a novel cyanoacrylate product when securing intravascular catheters inserted into prepared porcine skin. In vivo, canine subjects were used to implant various types of catheters. These catheters were secured with a novel catheter securement cyanoacrylate to test the strength and durability while undergoing simulated clinical stresses. RESULTS: In vitro, the catheter securement cyanoacrylate demonstrated superior strength over conventional catheter securement methods as well as other known cyanoacrylates. The catheter securement cyanoacrylate demonstrated the ability to maintain superior strength for up to 7 days. In vivo, the catheter securement cyanoacrylate demonstrated the ability to withstand five weight tugs per hour for a 3-h duration, alone, while securing three types of catheters in canine subjects. CONCLUSION: This is one of the first studies to provide quantitative data to support the use of cyanoacrylate for intravascular catheter securement. The results from this research suggest that the novel catheter securement cyanoacrylate can be a simple and cost-effective catheter securement device that can improve the current health care protocol for intravascular catheterization.

Intravascular catheter migration: A cross-sectional and health-economic comparison of adhesive and subcutaneous engineered stabilisation devices for intravascular device securement.

The Infusional Services Team at a large cancer centre in Belfast, Northern Ireland, performed a cross-sectional analysis of two catheter securement technologies to address an area of frequent, but underestimated concern - peripherally inserted central catheter migration and dislodgement. Healthcare practitioner and patient feedback, along with economic impact, were assessed. The costs associated with catheter replacement during the adhesive device group study period were calculated using an average cost per insertion, based on material costs required for the procedure. Other factors were the replacement cost of the adhesive engineered securement device with each dressing change. In the subcutaneous securement group, the material costs were adjusted for use of the subcutaneous device as it remained in situ for the duration of the catheters' dwell time. This review found that subcutaneous securement offers both patient and facilities a safe, effective and economical alternative for device securement with patients who are unable to tolerate or have successful securement with adhesive securement devices. The use of subcutaneous devices provided for reduced risks for peripherally inserted central catheters in terms of dislodgement, migration or malposition, alleviating the potential risks to develop catheter-related thrombosis and device-related infection.

Endoscopic Nasoenteral Feeding Tube Fixation with Hemoclip Reduces Tube Dislodgement.

BACKGROUND/AIMS: Spontaneous retrograde migration of nasoenteral feeding tubes is common in clinical practice. The aim of the present study was to evaluate the effectiveness of nasoenteral feeding tube tip fixation with hemoclips to prevent tube dislodgement. METHODS: We retrospectively reviewed patients who underwent insertion of an endoscopic nasoenteral feeding tube with or without tube tip fixation with hemoclips at the Asan Medical Center in Korea from January 2016 to December 2017. We compared the incidence of tube dislodgment and procedure-related complications between the two groups. RESULTS: Of the total 225 procedures, 72 were performed using the clip-assisted method, while 153 were performed using the standard non-clip-assisted method. Tube dislodgement occurred in two (2.8%) cases in the clipping group and in 26 (17.0%) in the non-clipping group (p = 0.003). Non-clipping group had a sevenfold higher risk of tube dislodgement compared to clipping group after adjustments in multivariable logistic regression (adjusted OR 7.97, 95% CI 1.82-35.00). The procedure time was not significantly different between the two groups (17.6 ± 8.5 min in the clipping group vs. 17.8 ± 9.4 min in the non-clipping group, p = 0.872). In addition, procedure-related complications, such as bleeding, aspiration pneumonia, Mallory-Weiss tear, ileus, and tube obstruction, were not different between the two groups. Achieving target calorie intake took 10.4 ± 10.5 days in the clipping group and 7.9 ± 7.9 days in the non-clipping group (p = 0.293). CONCLUSION: Clip-assisted fixation of nasoenteral feeding tube was effective in preventing tube dislodgement.

The suction-assisted endoscopic suture technique: A simple method for endotracheal suturing.

BACKGROUND: Silicone stents are commonly employed to treat subglottic stenosis. A frequent complication is the tendency of stents to migrate. As such, various techniques to secure stents have been developed over the years, none of which have gained large popularity. We present a novel, low-cost, and easy-to-perform technique herein. OBJECTIVES: To describe a novel surgical technique to secure silicone stents and prevent migration for management of subglottic stenosis. MATERIALS AND METHODS: After standard excision and dilation of stenotic portions in the subglottic or trachea. A silicone stent is introduced in a standard fashion. To secure the stent, an 18-G needle loaded with braided suture is inserted through skin, trachea, and stent. Endoscopic visualization then permits the surgeon to grasp the suture with forceps. A separate transcutaneous puncture site is performed with an 18-G needle attached to a 10-cc syringe (plunger removed) and blue tip suction within the empty syringe, creating an airtight suctioning tool. The grasped suture is gently introduced into the eye of the needle and quickly travels into the 10-cc syringe with suction assist, leaving both extracorporeal ends of the suture to tie. RESULTS: This stitch has been employed on seven occasions on four patients. There have been no episodes of stent migration. A laboratory model found the 18-G needle and braided 3-0 suture performed optimally. CONCLUSIONS: We present a novel surgical technique to secure silicone stents in management subglottic or tracheal stenosis. LEVEL OF EVIDENCE: Level 4 Laryngoscope, 130:E346-E348, 2020.