scholarly journals A novel method of endoscopic-assisted esophageal clearance in advanced achalasia

2018 ◽  
Vol 06 (01) ◽  
pp. E86-E89
Author(s):  
Shinwa Tanaka ◽  
Fumiaki Kawara ◽  
Takashi Toyonaga ◽  
Robert Bechara ◽  
Namiko Hoshi ◽  
...  
Keyword(s):  
Gastric Tube ◽  
Time Range ◽  
Procedure Time ◽  
Serious Adverse Events ◽  
Safety And Efficacy ◽  
Novel Technique ◽  
Esophageal Clearance ◽  
Novel Method ◽  
Endoscopic Myotomy ◽  
Median Procedure

Abstract Background and study aims In order to perform peroral endoscopic myotomy (POEM) safely, retained liquid and food debris must be removed before the procedure is started. We developed a novel technique using a super-slim gastroscope, and a gastric tube to remove retained food debris in achalasia patients. In this study, the safety and efficacy of this novel technique were investigated Patients and methods Eleven patients with achalasia were enrolled in this study and underwent this novel method for esophageal clearance. Results All patients had complete clearance of the retained food debris using this method. The median procedure time (range) was 13 (6 – 30) minutes. There were no serious adverse events (AEs) and one minor AE of mucosal erythema due to mucosal suctioning. Conclusion This novel method for esophageal clearance is safe and effective in achalasia patients with large amounts of retained food debris.

scholarly journals Angiographic Analysis of the Anatomical Variants in Genicular Artery Embolization

2021 ◽  
Author(s):  
Sandeep Bagla ◽  
Rachel Piechowiak ◽  
Abin Sajan ◽  
Julie Orlando ◽  
A Diego Hipolito Canario ◽  
...  
Keyword(s):  
Procedure Time ◽  
Technical Success ◽  
Artery Embolization ◽  
Novel Technique ◽  
Anterior Tibial ◽  
Branching Patterns ◽  
Genicular Artery ◽  
Arterial Anatomy ◽  
Lateral Superior Genicular Artery ◽  
Angiographic Findings

Abstract Purpose: Genicular artery embolization (GAE) has been proposed as a novel technique to treat painful synovitis related to osteoarthritis. An in-depth understanding of the genicular arterial anatomy is crucial to achieve technical success and avoid nontarget-related complications. Given the lack of previous angiographic description, the present study analyzes genicular arterial anatomy and proposes an angiographic classification system. Materials and Methods: Angiographic findings from 41 GAEs performed during two US clinical trials from January 2017 to July 2019 were reviewed to analyze the anatomical details of the following vessels: descending genicular artery (DGA), medial superior genicular artery (MSGA), medial inferior genicular artery (MIGA), lateral superior genicular artery (LSGA), lateral inferior genicular artery (LIGA), and anterior tibial recurrent artery (ATRA). The diameter, angle of origin, and anastomotic pathways were recorded for each vessel. The branching patterns were classified as: medially, M1 (3/3 arteries present) vs M2 (2/3 arteries present); and laterally, L1 (3/3 arteries present) vs L2 (2/3 arteries present). Results: A total of 91 genicular arteries were embolized: DGA (26.4%), MIGA (23.1%), MSGA (22.0%), LIGA (14.3%), and LSGA/ATRA (14.3%). The branching patterns were: medially = M1, 74.4% (n = 29), M2, 25.6% (n = 10); and laterally = L1, 94.9% (n = 37), L2, 5.1% (n = 2). A common origin for MSGA and LSGA was noted in 11 patients (28.2%). A direct DGA origin from the popliteal artery was reported in three patients (7.7%, n = 3). Conclusions: A thorough understanding of the geniculate arterial anatomy is important for maximizing postprocedural pain reduction while minimizing complications, procedure time, and radiation exposure during GAE.

A novel technique for mapping biopsy of bile duct cancer

Endoscopy ◽  
2020 ◽  
Author(s):  
Hirokazu Okada ◽  
Norimitsu Uza ◽  
Tomoaki Matsumori ◽  
Shimpei Matsumoto ◽  
Yuya Muramoto ◽  
...  
Keyword(s):  
Bile Duct ◽  
Intrahepatic Bile Duct ◽  
Preoperative Assessment ◽  
Median Number ◽  
Novel Technique ◽  
Minimal Trauma ◽  
Adequate Sampling ◽  
Novel Method ◽  
Longitudinal Extension ◽  
Mapping Biopsy

Abstract Background Accurate preoperative assessment of the longitudinal extension of perihilar cholangiocarcinoma (PHCC) is essential for treatment planning. Mapping biopsies for PHCC remain challenging owing to technical difficulties and insufficient sample amounts. The aim of this study was to investigate the usefulness of a novel technique for mapping biopsies of PHCC. Methods Our novel method focused on a biliary stent delivery system for mapping biopsies. Fifty patients with PHCC undergoing endoscopic transpapillary mapping biopsy using the novel method were reviewed from August 2015 to June 2019. Results The median number of biopsy samples was six (range 1 – 17), and the rate of adequate sampling was 91.4 % (266 /291). Biopsy from the intrahepatic bile duct was possible in 82.0 % of patients (41 /50), and negative margins were confirmed in the resected specimens from 34 /39 patients who underwent surgery (87.2 %). None of the patients had post-endoscopic retrograde cholangiopancreatography pancreatitis. Conclusions With our novel method, accurate assessment of the longitudinal extension of PHCC might be expected with minimal trauma to the duodenal papilla.

scholarly journals Safety and efficacy of polydimethylsiloxane (Macroplastique®) in women with stress urinary incontinence: analysis of data from patients who completed three years follow-up

2021 ◽  
Author(s):  
Gamal Ghoniem ◽  
Bilal Farhan ◽  
Mashrin Lira Chowdhury ◽  
Yanjun Chen
Keyword(s):  
Urinary Incontinence ◽  
Stress Urinary Incontinence ◽  
Serious Adverse Events ◽  
Safety And Efficacy ◽  
Medical Centers ◽  
High Satisfaction ◽  
High Satisfaction Rate ◽  
Time Observation ◽  
The Rose

Abstract Introduction and hypothesis This study aimed to report 3-year completed follow-up of the safety and efficacy of Macroplastique® (MPQ) in women with stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD). Methods This is a retrospective analysis of all women who completed 3-year follow-up post-MPQ injection(s) at ten medical centers. We used the ROSE registry data report of Macroplastique® [Macroplastique® Real-time Observation of Safety and Effectiveness (ROSE) registry P040050/PAS001 on 2017]. Subjective incontinence outcome and adverse effects were assessed. Results The study included all patients (n = 70) who completed 3-year follow-up after the last MPQ injection. Twenty-four of 70 (34%) patients had two injections; 21/70 (30%) patients reported Stamey grade 0 and 28/70 (40%) reported Stamey grade 1. The overall patient satisfaction was 68% who completed 3-year follow-up. The composite success rate (I-QoL, PGI-S, and Stamey grade improvement) was 51.4%. No serious adverse events (AE) were reported within the completed 3-year follow-up. Conclusions MPQ was found to be safe and efficacious for the treatment of SUI secondary to ISD in women. The overall high satisfaction rate was sustained from baseline to 3 years post-injection. Most complications were minor and transient without sequelae.

scholarly journals Single-Step Renal Dilatation Is a Novel Technique in Percutaneous Nephrolithotomy: A Prospective Randomised Study

2020 ◽  
Vol 20 (2) ◽  
pp. 70-73
Author(s):  
Md Shariful Islam ◽  
Md Shawkat Alam ◽  
AHM Mostofa Kamal ◽  
Md Asaduzzamman ◽  
Md Ruhul Quddus
Keyword(s):  
Percutaneous Nephrolithotomy ◽  
Perioperative Complications ◽  
Single Step ◽  
Safety And Efficacy ◽  
X Ray ◽  
Randomised Study ◽  
Operative Duration ◽  
Novel Technique ◽  
Significant Difference ◽  
Prospective Randomised Study

Purpose: To evaluate the feasibility, safety and efficacy of one-shot dilation (OSD) in percutaneous nephrolithotomy (PCNL). Materials and Methods: In a prospective randomised study including 62 patients divided into two groups, the first had RD before PCNL using the standard metallic telescopic dilators (Alken), and the second had RD using the 30-F Amplatz dilator over the central Alken dilator. The operative duration, with X-ray exposure, was calculated. The procedure outcome in terms of complications, stone-free rates and hospital stay was evaluated statistically. Results : The tract was dilated correctly in all cases. The operative duration and X-ray exposure was shorter in patients undergoing single-step RD (P < 0.05). There were perioperative complications, according to the Clavien grading system, in 15 (25%) patients but there was no statistically significant difference between the groups. The stone-free rates were comparable in both groups. Conclusion : A single-step RD during PCNL is feasible, with a shorter operative duration and X-ray exposure. The outcomes were comparable with those of a standard metallic telescopic RD Bangladesh Journal of Urology, Vol. 20, No. 2, July 2017 p.70-73

Basis of Novel Technique for Spatial Objects Shaping With High-Pressure Abrasive Water Jet

2010 ◽  
Vol 132 (5) ◽  
Author(s):  
P. J. Borkowski ◽  
J. A. Borkowski
Keyword(s):  
High Pressure ◽  
Feed Rate ◽  
Spatial Model ◽  
Theoretical Basis ◽  
Water Jet ◽  
Abrasive Water Jet ◽  
Spatial Objects ◽  
Novel Technique ◽  
Raster Image ◽  
Novel Method

Novel method for the 3D shaping of different materials using a high-pressure abrasive water jet is presented in the paper. For the steering movement process of the jet, a principle similar to the raster image way of record and readout was used. However, respective colors of pixels of such a bitmap are connected with adequate jet feed rate that causes erosion of material with adequate depth. Thanks to that innovation, one can observe spatial imaging of the object. Theoretical basis as well as spatial model of material shaping including steering program is presented in. There are also presented experimental erosion results as well as practical examples of the object’s bas-relief made of metal.

scholarly journals Subcutaneous Abatacept for the Treatment of Rheumatoid Arthritis: Longterm Data from the ACQUIRE Trial

2014 ◽  
Vol 41 (4) ◽  
pp. 629-639 ◽  
Author(s):  
Mark C. Genovese ◽  
César Pacheco Tena ◽  
Arturo Covarrubias ◽  
Gustavo Leon ◽  
Eduardo Mysler ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Severe Disease ◽  
Incidence Rates ◽  
Phase Iii ◽  
Inadequate Response ◽  
Open Label ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Safety And Efficacy ◽  
Link Type

Objective.Assess longterm tolerability, safety, and efficacy of subcutaneous (SC) abatacept (ABA) in methotrexate-refractory patients with rheumatoid arthritis (RA).Methods.The phase III, multinational Abatacept Comparison of Sub[QU]cutaneous Versus Intravenous in Inadequate Responders to MethotrexatE (ACQUIRE) trial comprised a 6-month, randomized, double-blind (DB) period, in which patients received intravenous (IV) or SC ABA, plus MTX, followed by an open-label, longterm extension (LTE), in which patients received SC ABA, 125 mg/week. Safety and efficacy from the LTE (∼3.5 yrs of exposure) are reported.Results.Patients who completed the DB period (1372/1385, 99.1%) entered the LTE; 1134 patients (82.7%) kept taking the treatment at time of reporting. Mean (SD) was 31.9 months (6.8); median (range) exposure was 33.0 (8–44) months. Patients entering the LTE had longstanding, moderate-to-severe disease [mean 7.6 (7.9) yrs and DAS28 (C-reactive protein) 6.2 (0.9)]. Incidence rates (events/100 patient-yrs) were reported for serious adverse events (8.76, 95% CI 7.71, 9.95), infections (44.80, 95% CI 41.76, 48.01), serious infections (1.72, 95% CI 1.30, 2.27), malignancies (1.19, 95% CI 0.86, 1.66), and autoimmune events (1.31, 95% CI 0.95, 1.79). Twenty-seven patients (2%) experienced injection-site reactions; all except 1 were mild. American College of Rheumatology 20, 50, and 70 responses achieved during the DB period were maintained through the LTE, and on Day 981 were 80.2% (95% CI 77.2, 83.2), 63.5% (95% CI 58.2, 68.9), and 39.5% (95% CI 34.0, 44.9) for patients who kept taking SC ABA, and 80.0% (95% CI 77.0, 83.0), 63.2% (95% CI 57.8, 68.7), and 39.2% (95% CI 33.7, 44.7) for those who switched from IV to SC ABA.Conclusion.These findings support SC ABA as a well-tolerated and efficacious longterm treatment for patients with RA and inadequate response to MTX (ClinicalTrials.gov identifier NCT00559585).

Abstract 15821: Safety and Efficacy of Non-invasive Ventilation During Exercise Training in Patients With Acute Heart Failure. A Randomized Prospective Controlled Study

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Mayron F Oliveira ◽  
Rita L Santos ◽  
Vanessa M Mendez ◽  
Priscila A Sperandio ◽  
Iracema I Umeda ◽  
...  
Keyword(s):  
Heart Failure ◽  
Exercise Training ◽  
Adverse Events ◽  
Hospital Stay ◽  
Length Of Hospital Stay ◽  
Invasive Ventilation ◽  
Serious Adverse Events ◽  
Safety And Efficacy ◽  
Non Invasive ◽  
Non Invasive Ventilation

Background: Exercise training (ET) is well established to improve functional capacity and quality of life in patients (pts) with chronic heart failure. However, the ET benefits in acute heart failure (AHF) are unknown. Purpose: We aimed to study the safety and efficacy of ET alone or combined with non-invasive ventilation (NIV) compared to standard medical treatment in hospitalized pts with AHF. Methods: Twenty-nine pts with AHF (68% ischemic), 56±7 years, left ventricle ejection fraction of 25±5%, NTproBNP of 2456±730, 6-minute walk test distance (6MWD = 225±39meters) were randomized into 3 groups: ET + NIV with sub therapeutic positive airway pressure (PAP) (ET,n=9), ET + NIV set to 14 of inspiratory and 8 cmH2O of expiratory PAP, respectively (EV,n=11) and standard treatment (CO,n=9). The ET and EV groups performed a daily session of unloaded exercise on cycle ergometer for 20 min or tolerance limit, for 8 consecutives days. In EV and ET, oxygen pulse saturation (SpO2), heart rate (HR), respiratory rate (RR), blood pressure (BP), blood lactate were measured at baseline (D1), during exercise, and at day 10 (D10). Serious adverse events (death or worsening heart failure) were also assessed on D10. Results: Length of hospital stay was shorter in EV group (17±10 days) compared to ET (23±8 days) and CO (39±15 days) (p<0,05). There were more serious adverse events in CO (66,6%) compared to both EV and ET (15%). Dobutamine use at D10 was less frequent in EV (18,2%) and ET (22,2%) groups than in CO (33,3%) (p<0.05). There was a marked improvement in Δ6MWD between D1 and D10 in EV (Δ127±72 meters), though increase in Δ6MWD was also seen in ET (Δ72±26 meters) and CO (Δ41±19meters), p<0,05. The EV group also showed higher endurance and lower peak HR at end-exercise than ET at D10 (128±10 vs. 92±8 min and 73±12 vs. 104±25 bpm, respectively; p<0,05). There was a similar reduction in NTproBNP levels but no differences were found in BP, SpO2, RR and blood lactate. Conclusion: Aerobic exercise in AHF was safe, reduced length of hospital stay and need for inotropics at D10. NIV + ET increased exercise endurance with lower cardiovascular stress.

Safety and Efficacy of Fremanezumab for the Prevention of Migraine: a Meta-analysis from Random Clinical Trails

2020 ◽  
Author(s):  
Bixi Gao ◽  
Nan Sun ◽  
Yanbo Yang ◽  
Yue Sun ◽  
Mingjia Chen ◽  
...  
Keyword(s):  
Adverse Events ◽  
Neurological Diseases ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Serious Adverse Events ◽  
Safety And Efficacy ◽  
Therapeutic Drugs ◽  
Primary Endpoints ◽  
Calcitonin Gene ◽  
Clinical Trails

Abstract Background Fremanezumab (TEV-48125) is a fully humanized immunoglobulin G isotype 2a selective monoclonal antibody that potently binds to calcitonin gene-related peptide (CGRP). It is one of novel therapeutic drugs for the prevention of migraine, which is one of the most common neurological diseases worldwide. Several clinical trails have been conducted to investigate the safety and efficacy of fremanezumab, but there is no systematic review of existing literature has been performed. Hence, we performed a meta-analysis to investigate the efficacy and safety of fremanezumab for prevention of migraine. Method Pubmed (MEDLINE), Embase, and Cochrane Library were searched from January 2001 to August 2019 for randomized controlled trials (RCTs). Five RCTs with 3379 patients were finally included in our study. Result We pooled 3379 patients from 5 RCTs, the primary endpoints were mean monthly migraine and headache days, baseline to week 12. We found that fremanezumab led to a significant reduction in migraine days (P < 0.0001) and headache days (P < 0.0001) during 12 weeks compared with placebo. In addition, after using fremanezumab, the risk of at least one adverse event (P=0.001) or related to the trail regimen (P=0.0005) significantly increase compared with placebo. Conclusions Fremanezumab has good efficacy for the prevention of migraine. The administration of fremanezumab can cause some mild adverse events but not serious adverse events.

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