BACKGROUND: The i-gel® Plus is a modified version of the i-gel® supraglottic airway device. It contains a wider drainage port; a longer tip; ramps inside the breathing channel; and an additional port for oxygen delivery. There has been no prospective evaluation of this device in clinical practice. METHODS: This international, multicentre, prospective cohort study aimed to evaluate the performance of the i-gel Plus in adult patients undergoing elective procedures under general anaesthesia. The primary outcome was overall insertion success rate, defined as the ability to provide effective airway management through the device from insertion until the end of the surgical procedure. Secondary outcomes included device performance and incidence of postoperative adverse events. Data from the first 1000 patients are reported. RESULTS: In total, 1012 patients were enrolled; 12 forms were excluded from the final analysis due to incomplete data leaving 1000 included patients (545 female). Overall insertion success rate was 98.6%, with a first-attempt success rate of insertion of 88.2%. A significant difference between females and males was seen for the overall success rate (97.4% vs. 99.6% respectively) but not for first-attempt successful insertion. Mean (SD) oropharyngeal seal pressure was 32 (7) cmH2O. The only independent factor that increased the risk of first-attempt failure was low operator experience. Complications included desaturation < 85% in 0.6%; traces of blood on the device in 7.4%; laryngospasm in 0.5%; and gastric contents inside the bowl in 0.2% of patients. CONCLUSIONS: The i-gel Plus appears to be an effective supraglottic airway device that is associated with a high insertion success rate and a reasonably low incidence of complications.

• MeSH
• Anesthesia, General MeSH
• Equipment Design MeSH
• Adult MeSH
• Elective Surgical Procedures * MeSH
• Intubation, Intratracheal * instrumentation   methods   MeSH
• Cohort Studies MeSH
• Laryngeal Masks * MeSH
• Middle Aged MeSH
• Humans MeSH
• Postoperative Complications epidemiology   MeSH
• Prospective Studies MeSH
• Aged MeSH
• Airway Management instrumentation   methods   MeSH
• Check Tag
• Adult MeSH
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Multicenter Study MeSH

PRCIS: Deep sclerectomy (DS) with fibrin adhesive can constitute a safe alternative to the classic procedure using sutures, providing nonallergenic, nontoxic, and secure adhesion with no sign of aqueous humor outflow obstruction postoperatively. OBJECTIVE: To evaluate short and medium-term postoperative results of DS with a fibrin sealant. PATIENTS AND METHODS: This prospective, noncomparative, interventional case series involves 12 eyes of 12 patients with uncontrolled open angle glaucoma who underwent DS with Esnoper (Clip or V2000) implant between February 2021 and March 2022. A novel method of wound closure (sclera, Tenon fascia, and conjunctiva) employing fibrin glue was used instead of classic sutures. Surgical outcomes assessed include: intraocular pressure and glaucoma therapy reduction, best-corrected visual acuity changes, and number of complications registered peri and postoperatively. All measurements were performed preoperatively, as well as at 1 day, at 1 and 2 weeks, and at 1, 2, 3, 6, 9, and 12 months after surgery. RESULTS: The mean intraocular pressure decreased from 24.0 ± 9.1 mm Hg to 13.8 ± 6.3 mm Hg at 1 year postoperatively ( P < 0.001). Kaplan-Meier survival analysis revealed complete and qualified success rates of 83.3% and 91.7%. The mean glaucoma therapy decreased from 3.2 ± 1.1 to 0.8 ± 1.3 drugs 12 months after surgery ( P < 0.001). Nd:YAG goniopunture was performed in 2 eyes at 1 and 12 months postoperatively. No significant best-corrected visual acuity changes were registered. Perioperatively, we noted a trabeculo-descemet microperforation in 1 eye, transient hypotony in 5 eyes, and mild hyphema in 2 eyes. CONCLUSIONS: Fibrin adhesive provided an effective closure in sutureless DS in the patients included in our study. This modification of classical DS may simplify the surgical technique, ensure secure wound adaptation, optimize healing, and lower the risk of inflammation and fibrosis postoperatively.

• MeSH
• Sutureless Surgical Procedures * methods   MeSH
• Glaucoma Drainage Implants MeSH
• Fibrin Tissue Adhesive * therapeutic use   MeSH
• Glaucoma, Open-Angle * surgery   physiopathology   MeSH
• Middle Aged MeSH
• Humans MeSH
• Follow-Up Studies MeSH
• Intraocular Pressure * physiology   MeSH
• Prospective Studies MeSH
• Aged, 80 and over MeSH
• Aged MeSH
• Sclera * surgery   MeSH
• Sclerostomy * methods   MeSH
• Tissue Adhesives * therapeutic use   MeSH
• Tonometry, Ocular MeSH
• Treatment Outcome MeSH
• Visual Acuity * physiology   MeSH
• Check Tag
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Aged, 80 and over MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH

PURPOSE: To evaluate the safety and efficacy of using corneal stromal lenticules (CSLs) obtained during refractive surgery Refractive Lenticule Extraction (ReLEx) with the Small Incision Lenticule Extraction (SMILE) procedure for the treatment of corneal ulcers. METHODS: This retrospective study included 12 eyes of 12 patients, 7 men and 5 women with varying degrees of corneal ulcer. The mean age was 64 ± 18 (range 34 to 95 years). The monitoring included corrected distance visual acuity (CDVA), slit-lamp biomicroscopy examination, a Seidel test, stability of the graft and anterior segment optical coherence tomography (AS-OCT) inspection. Patients were closely monitored for possible postoperative complications for at least 6 months. RESULTS: In 7/12 (58%) eyes, the corneal ulcer was successfully sealed with CSL and amniotic membrane (AM) without the need for any additional surgical intervention. In 3 eyes, penetrating keratoplasty (PK) was needed in addition to CSL transplantation and in 2 eyes the scleral patch was used to fully seal after CSL transplantation. During the follow-up period no signs of rejection or infection were detected in any patient. CONCLUSION: The use of CSLs from ReLEx SMILE may be considered as an alternative method for the treatment of corneal ulcers before a more extensive and definitive solution - PK - is used. Our preliminary findings suggest that properly performed CSL transplantation using cryopreserved lenticules is a safe and effective method to temporarily cover the corneal partial-thickness defect or even perforation.

• MeSH
• Adult MeSH
• Middle Aged MeSH
• Humans MeSH
• Retrospective Studies MeSH
• Aged, 80 and over MeSH
• Aged MeSH
• Corneal Stroma surgery   MeSH
• Corneal Transplantation * methods   MeSH
• Corneal Ulcer * surgery   MeSH
• Ulcer surgery   MeSH
• Check Tag
• Adult MeSH
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Aged, 80 and over MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH

INTRODUCTION: Commissioning, calibration, and quality control procedures for nuclear medicine imaging systems are typically performed using hollow containers filled with radionuclide solutions. This leads to multiple sources of uncertainty, many of which can be overcome by using traceable, sealed, long-lived surrogate sources containing a radionuclide of comparable energies and emission probabilities. This study presents the results of a quantitative SPECT/CT imaging comparison exercise performed within the MRTDosimetry consortium to assess the feasibility of using 133Ba as a surrogate for 131I imaging. MATERIALS AND METHODS: Two sets of four traceable 133Ba sources were produced at two National Metrology Institutes and encapsulated in 3D-printed cylinders (volume range 1.68-107.4 mL). Corresponding hollow cylinders to be filled with liquid 131I and a mounting baseplate for repeatable positioning within a Jaszczak phantom were also produced. A quantitative SPECT/CT imaging comparison exercise was conducted between seven members of the consortium (eight SPECT/CT systems from two major vendors) based on a standardised protocol. Each site had to perform three measurements with the two sets of 133Ba sources and liquid 131I. RESULTS: As anticipated, the 131I pseudo-image calibration factors (cps/MBq) were higher than those for 133Ba for all reconstructions and systems. A site-specific cross-calibration reduced the performance differences between both radionuclides with respect to a cross-calibration based on the ratio of emission probabilities from a median of 12-1.5%. The site-specific cross-calibration method also showed agreement between 133Ba and 131I for all cylinder volumes, which highlights the potential use of 133Ba sources to calculate recovery coefficients for partial volume correction. CONCLUSION: This comparison exercise demonstrated that traceable solid 133Ba sources can be used as surrogate for liquid 131I imaging. The use of solid surrogate sources could solve the radiation protection problem inherent in the preparation of phantoms with 131I liquid activity solutions as well as reduce the measurement uncertainties in the activity. This is particularly relevant for stability measurements, which have to be carried out at regular intervals.

• Publication type
• Journal Article MeSH

Úvod: Cílem této studie bylo porovnat dva systémy uzavírání žil kyanoakrylátovým lepidlem, VenaSealTM a VariClose®, v léčbě povrchové žilní insuficience. Metody: Byla provedena retrospektivní analýza pacientů léčených od dubna 2018 do dubna 2022 kyanoakrylátovými lepidly pro insuficienci povrchových žil dolních končetin v jednom centru. Výsledky: Systém VariClose® byl použit u 27 pacientů (30 žil) a systém VenaSealTM u 97 pacientů (125 žil). Medián sledování pacientů léčených systémy VariClose® a VenaSealTM dosahoval 267 (IQR 223) a 201 (IQR 280) dnů. Po roce došlo k rekanalizaci u 11 žil léčených systémem VariClose® a u 5 žil léčených systémem VenaSealTM. Míra okluze odhadnutá Kaplanovou-Meierovou metodou v 30, 90, 180 a 360 dnech činila pro žíly léčené systémem VariClose® 100 %, 96 %, 83 % a 42 % a pro žíly léčené systémem VenaSealTM 100 %, 98 %, 96 % a 91 % (p < 0,01). Závěr: Systém VenaSealTM měl významně lepší míru okluze než systém VariClose®.

Objective: The goal of this study was to compare the cyanoacrylate venous sealing systems VenaSealTM and VariClose® in the treatment of superficial venous insufficiency. Methods: A single-centre retrospective analysis on patients treated between April 2018 and April 2022 with cyanoacrylate adhesives for lower limb superficial truncal vein insufficiency was performed. Results: The VariClose® system was used in 27 patients (30 veins) and the VenaSealTM system in 97 patients (125 veins). The median follow-up periods for patients treated with VariClose® and VenaSealTM systems were 267 (IQR 223) and 201 (IQR 280) days, respectively. At one year, recanalization occurred in 11 veins treated with the VariClose® system and 5 veins treated with the VenaSealTM system. The occlusion rates estimated by the Kaplan-Meier method at 30, 90, 180, and 360 days were 100%, 96%, 83%, and 42% for veins treated with the VariClose® system and 100%, 98%, 96%, and 91% for veins treated with the VenaSealTM system (p <0.01). Conclusions: The VenaSealTM system had significantly better occlusion rates than the VariClose® system.

• Keywords
• VenaSealTM, VariClose,
• MeSH
• Kaplan-Meier Estimate MeSH
• Cyanoacrylates * administration & dosage   pharmacology   therapeutic use   MeSH
• Humans MeSH
• Retrospective Studies MeSH
• Varicose Veins therapy   MeSH
• Saphenous Vein surgery   pathology   MeSH
• Veins pathology   MeSH
• Treatment Outcome MeSH
• Vascular Closure Devices MeSH
• Venous Insufficiency therapy   MeSH
• Check Tag
• Humans MeSH
• Publication type
• Research Support, Non-U.S. Gov't MeSH

Evolutionary and ecological processes affecting the interactions between hosts and parasites in the aquatic environment are at display in the Baltic Sea, a young and ecologically unstable marine ecosystem, where fluctuating abiotic and biotic factors affect the parasitofauna in fish. The dynamic infections of Baltic cod, a subpopulation of the Atlantic cod (Gadus morhua Linnaeus), with third stage anisakid nematode larvae of Pseudoterranova decipiens (Krabbe, 1878) and Contracaecum osculatum (Rudolphi, 1802) have increased following a significant increase of the Baltic grey seal Halichoerus grypus (Fabricius) population in the region. Cod serves as a paratenic host and marine mammals, pinnipeds, are definitive hosts releasing parasite eggs, with faeces, to the marine environment, where embryonation and hatching of the third stage larva take place. The parasite has no obligate intermediate hosts, but various invertebrates, smaller fish and cod act as paratenic hosts transmitting the infection to the seal. Contracaecum osculatum has an impact on the physiological performance of the cod, which optimises transmission of the larva from fish to seal. Thus, a muscle mass decrease of nearly 50% may result from heavy C. osculatum infections, probably amplified by a restricted food availability. The muscle atrophy is likely to reduce the escape reactions of the fish when meeting a foraging seal. In certain regions, where fish and seals are restricted in their migration patterns, such as the semi-enclosed Baltic Sea, the predation may contribute to a severe cod stock depletion. The parasites are zoonotic and represent a human health risk, when consumers ingest insufficiently heat- or freeze-treated infected products. Marked infections of the cod were previously reported during periods with elevated seal populations (late 19th and middle 20th century) and various scenarios for management of risk factors are evaluated in an evolutionary context.

• MeSH
• Ascaridoidea * physiology   MeSH
• Ecosystem MeSH
• Gadus morhua * parasitology   MeSH
• Larva physiology   MeSH
• Humans MeSH
• Fish Diseases * epidemiology   parasitology   MeSH
• Parasites * MeSH
• Fishes MeSH
• Seals, Earless * parasitology   MeSH
• Animals MeSH
• Check Tag
• Humans MeSH
• Animals MeSH
• Publication type
• Journal Article MeSH

OBJECTIVES: The objective of this study was to observe and to measure the impact of corundum sandblasting on the thickness of the Immediate dentin sealing layer. METHODS: 20 recently extracted molars were collected and divided randomly into two groups. A standardized preparation was performed on each tooth and the Optibond FL dentin bonding agent (Kerr, Orange, USA) was applied on the prepared surface according to the manufacturer’s instructions. The surface was then partially sandblasted. RONDOflex plus 360 (KaVo, Bieberach an der Riss, Germany) and Airsonic Mini-Sandblaster (Hager et Werken, Duisburg, Germany) were used. Microscope observations were made. RESULTS: The arithmetic mean of the Optibond FL dentin bonding agent film thickness was 48.72 μm (Group 1=45.55 μm and Group 2=51.88 μm). The dentin bonding agent layer thickness was reduced to the average value of 17,12 μm by RONDOflex plus 360 sandblasting (Group 1). The zero value was recorded in 16 % of the locations. The Airsonic Mini-Sandblaster sandblasting changed the average thickness of the dentin bonding agent layer to 13.25 μm with 31 % of zero values (Group 2). CONCLUSION: The results of this research lead to a reflection on modifications of the immediate dentin sealing procedure (Tab. 4, Fig. 3, Ref. 28).

• MeSH
• Dentin-Bonding Agents * classification   MeSH
• Humans MeSH
• Microscopy MeSH
• Molar drug effects   MeSH
• Aluminum Oxide MeSH
• Air Abrasion, Dental * methods   MeSH
• Statistics as Topic MeSH
• Dental Enamel diagnostic imaging   drug effects   MeSH
• Check Tag
• Humans MeSH
• Publication type
• Observational Study MeSH
• Research Support, Non-U.S. Gov't MeSH

BACKGROUND: Anastomotic leak after low anterior rectal resection is a dreadful complication. Early diagnosis, prompt management of sepsis followed by closure of anastomotic defect may increase chances of anastomotic salvage. In this randomized experimental study, we evaluated two different methods of trans-anal anastomotic repair. METHODS: A model of anastomotic leak was created in 42 male pigs. Laparoscopic low anterior resection was performed with anastomosis created using a circular stapler with half of the staples removed. Two days later, animals were randomized into a TAMIS (trans-anal minimally invasive surgery) repair, endoscopic suture (ENDO) or control group with no treatment (CONTROL). Signs of intraabdominal infection (IAI), macroscopic anastomotic healing and burst tests were evaluated to assess closure quality after animals were sacrificed on the ninth postoperative day. RESULTS: Closure was technically feasible in all 28 animals. Two animals had to be euthanized due to progressive sepsis at four and five days after endoscopic closure. Healed anastomosis with no visible defect was observed in 10/14 and 11/14 animals in TAMIS and ENDO groups, respectively, versus 2/14 in CONTROL (p < 0.05). Overall IAI rate was significantly lower in TAMIS (4/14; p = 0.006) and ENDO (5/14; p = 0.018) compared to CONTROL (12/14). Burst tests confirmed sealed closure in healed anastomosis with a median failure pressure of 190 (110-300) mmHg in TAMIS and 200 (100-300) mmHg in ENDO group (p = 0.644). CONCLUSION: In this randomized experimental study, we found that both evaluated techniques are effective in early repair of dehiscent colorectal anastomosis with a high healing rate.

• MeSH
• Anastomosis, Surgical methods   MeSH
• Humans MeSH
• Rectal Neoplasms * surgery   MeSH
• Anastomotic Leak etiology   surgery   MeSH
• Swine MeSH
• Rectum surgery   MeSH
• Sepsis * MeSH
• Animals MeSH
• Check Tag
• Humans MeSH
• Male MeSH
• Female MeSH
• Animals MeSH
• Publication type
• Journal Article MeSH

Surgical procedures are often impeded by bleeding and/or leakage of body fluids. These complications cannot always be resolved by conventional surgical techniques. Hemopatch® is a hemostatic patch that also functions as a sealant. Here we document the effectiveness and safety of Hemopatch® for routine procedures of multiple surgical disciplines. To this end, we performed a prospective, multicenter, single-arm, observational registry study. Patients were eligible if they had received Hemopatch® during an open or minimally invasive procedure in one of these specialties: hepatobiliary, cardiovascular, urological, neurological/spinal, general, or lung surgery. Patients were excluded if they had a known hypersensitivity to bovine proteins or brilliant blue, intraoperative pulsatile or severe bleeding and/or infection at the target application site (TAS). The primary endpoint for intraoperative effectiveness was hemostasis assessed as the percentage of patients achieving hemostasis within 2 min and the percentage of patients achieving hemostasis without re-bleeding at the time of surgical closure. The registry enrolled 621 patients at 23 study sites in six European countries. Six hundred twenty patients had completed follow-up information. Hemostasis within 2 min was achieved at 463 (74.5%) of all 621 TASs. Hemostasis without re-bleeding was observed at 620 (99.8%) TASs. Adverse events were reported in 64 patients (10.3%). This Hemopatch® registry shows that Hemopatch® efficiently establishes hemostasis and sealing in a variety of surgical specialties, including minimally invasive procedures. Furthermore, we provide evidence for the safety of Hemopatch® across all the specialties included in the registry. This study is registered at clinicaltrials.gov: NCT03392662.

• MeSH
• Hemostatics * adverse effects   MeSH
• Hemostasis, Surgical methods   MeSH
• Blood Loss, Surgical MeSH
• Humans MeSH
• Specialties, Surgical * MeSH
• Prospective Studies MeSH
• Registries MeSH
• Cattle MeSH
• Treatment Outcome MeSH
• Animals MeSH
• Check Tag
• Humans MeSH
• Cattle MeSH
• Animals MeSH
• Publication type
• Journal Article MeSH
• Multicenter Study MeSH
• Observational Study MeSH

PURPOSE: An EFOMP Working Group (WG) was created in 2020 to establish recommendations for PET/CT/MRI Quality Control (QC). The WG's intention was to create a document containing a set of measurements suitable for routine practice. In order to map the current situation in PET facilities, the WG prepared a survey addressed to European Medical Physics Experts (MPE). METHODS: The survey was conducted using an electronic questionnaire with 10 sections, for a total of 43 multiple choice or open questions. Data regarding general information, model of installed scanners, contract of maintenance and phantoms available were collected. The focal part of the questionnaire concerned the QC protocol adopted and accreditation programs. RESULTS: 123 answers from 24 countries were collected. 90.2% of the respondents are affiliated as staff MPEs; 45% have non-digital TOF PET/CT scanners with a contract of maintenance (97.6%). In 98.4% and 86.8% of responding centres a sealed source for daily QC and the NEMA Image Quality Phantom were present. 94.3% of respondents perform daily QC according to manufacturer recommendations, while NEMA Tests are not performed routinely (51.2%). 56.1% of the respondents have scanners accredited by a national or international organization. 56% of the centres perform annual CT tests, while more than 90% do not perform any MRI QCs. CONCLUSIONS: The results of the survey show that there is a lack of harmonization in the PET QC procedures across Europe. The information obtained will guide the WG in proposing a guideline containing a set of measurements suitable for the clinical routine.

• MeSH
• Phantoms, Imaging MeSH
• Humans MeSH
• Magnetic Resonance Imaging MeSH
• Positron Emission Tomography Computed Tomography * MeSH
• Positron-Emission Tomography * methods   MeSH
• Surveys and Questionnaires MeSH
• Quality Control MeSH
• Check Tag
• Humans MeSH
• Publication type
• Journal Article MeSH
• Geographicals
• Europe MeSH