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Background Adverse drug reactions (ADRs) are regarded as a major cause of death and a major contributor to public health costs. For the active surveillance of drug safety, the use of real-world data and real-world evidence as part of the overall pharmacovigilance process is important. In this regard, many studies apply the data-driven approaches to support pharmacovigilance. We developed a pharmacovigilance data-processing pipeline (PDP) that utilized electronic health records (EHR) and spontaneous reporting system (SRS) data to explore pharmacovigilance signals. Methods To this end, we integrated two medical data sources: Konyang University Hospital (KYUH) EHR and the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). As part of the presented PDP, we converted EHR data on the Observation Medical Outcomes Partnership (OMOP) data model. To evaluate the ability of using the proposed PDP for pharmacovigilance purposes, we performed a statistical validation using drugs that induce ear disorders. Results To validate the presented PDP, we extracted six drugs from the EHR that were significantly involved in ADRs causing ear disorders: nortriptyline, (hazard ratio [HR] 8.06, 95% CI 2.41–26.91); metoclopramide (HR 3.35, 95% CI 3.01–3.74); doxycycline (HR 1.73, 95% CI 1.14–2.62); digoxin (HR 1.60, 95% CI 1.08–2.38); acetaminophen (HR 1.59, 95% CI 1.47–1.72); and sucralfate (HR 1.21, 95% CI 1.06–1.38). In FAERS, the strongest associations were found for nortriptyline (reporting odds ratio [ROR] 1.94, 95% CI 1.73–2.16), sucralfate (ROR 1.22, 95% CI 1.01–1.45), doxycycline (ROR 1.30, 95% CI 1.20–1.40), and hydroxyzine (ROR 1.17, 95% CI 1.06–1.29). We confirmed the results in a meta-analysis using random and fixed models for doxycycline, hydroxyzine, metoclopramide, nortriptyline, and sucralfate. Conclusions The proposed PDP could support active surveillance and the strengthening of potential ADR signals via real-world data sources. In addition, the PDP was able to generate real-world evidence for drug safety.

Purpose: To evaluate corneal biomechanical changes and their correlation with the percentage of tissue altered (PTA) in myopic femtosecond (FS)-flap LASIK. Methods: Prospective longitudinal observational study of 80 eyes of FS LASIK. Demographic details, LASIK parameters, preoperative and postoperative (day 1, month 1, 3, and 6), UCVA, BCVA, refraction, corneal topography, corneal hysteresis (CH), and a corneal resistance factor (CRF) were noted. Change in CH and CRF and its correlation with PTA were analyzed. Data were analyzed in three subgroups [subgroup 1: PTA 23 to

Persistent Truncus Arteriosus is a cyanotic congenital heart anomaly in which a single trunk supplies both the pulmonary and systemic circulation, instead of a separate aorta and a pulmonary trunk. It is usually classified as a conotruncal anomaly. Due to parallel fetal circulation, truncus arteriosus does not cause any haemodynamic problem in utero. However it is a major problem postnatally and, if left untreated, approximately 80% of infants die within the first year. Diagnosis should be made early by radiologists and cardiologists due to fatal illness. We found it valuable to present a case of truncus arteriosus with computerized tomography findings because of its rare occurrence.

Objective: Peritonsillar abscess (PTA) is the most common deep space infection of the head and neck, affecting thousands of people annually with high treatment costs. The purpose of this project was to determine how in-network emergency departments (EDs) adhere to generally accepted guidelines regarding diagnosis and management of potential PTAs. Methods: The authors performed a retrospective chart review to identify patients with PTA in five EDs in one year. Information pertaining to diagnostic tests, treatment, and airway status was also collected. Descriptive analysis was used to assess if EDs were consistent with generally accepted guidelines. Results: Six hundred twenty-one patient records were identified and 140 were included in final analysis. Out of 140 patients, 71 were admitted for inpatient management and 23 were admitted for observation. Of the 46 patients diagnosed and discharged from the ED, 61% received a computerized tomography (CT) scan and only 39% had PTA drainage performed. Four (3%) patients received a point of care ultrasound and a CT scan and no patient received only an ultrasound. Out of all patients, 116/140 received a CT scan and 22 received drainage in the ED. The remainder of these patients either had drainage performed by an otolaryngologist or had no drainage performed. Of the 94 patients admitted for inpatient or observation, 84 received a CT scan and six received drainage by an ED physician. Only 62% of patients were given a penicillin derivative and 29% were given clindamycin, which has no Gram-negative coverage. Conclusion: One-third of PTA patients were managed within the ED, far less than similar studies. Of these, over 50% received a CT scan and less than 50% had PTA drainage. PTA drainage can improve patients’ symptoms and antibiotic effectiveness. The majority of patients were prescribed a penicillin derivative with or without another antibiotic.

A 71-yr-old man was transferred to our institution with multiple and recurrent high-grade pTa bladder cancer 26 mo after an initial presentation of multiple and large pTa low-grade tumors and concomitant carcinoma in situ, treated with transurethral resection plus 6-mo postoperative mitomycin C. This case discusses several treatment options in the absence of bacillus Calmette-Guerin (BCG). Immediate radical cystectomy is an option with excellent survival, since there is a substantial risk of understaging and disease progression; however, this results in overtreatment in similar to 50% of these patients. Therefore, a conservative approach could be intravesical combination therapy such as gemcitabine/docetaxel or epirubicin/interferon. In addition, device-assisted intravesical therapy is becoming an option to consider. Finally, patients could be included in trials such as immunotherapy trials. Patient summary: This 71-yr-old patient was diagnosed with recurrent, moderately severe noninvasive bladder tumors, which were removed. The recommended additional therapy, intravesical bacillus Calmette-Guerin (BCG) instillations, was not available. Both the pros and the cons of radical surgery (bladder removal) and a more conservative approach (other intravesical treatments) are discussed. (c) 2019 The Authors. Published by Elsevier B.V. on behalf of European Association of Urology. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

The outcomes of carbon dioxide digital subtraction angiography (CO2-DSA) for performing percutaneous transluminal balloon angioplasty (balloon PTA)in hemodialysis patients has not been fully clarified. The purpose was to compare the outcomes of balloon PTA of hemodialysis shunts in terms of vessel patency between patients treated using CO2-DSA and conventional digital subtraction angiography using iodine contrast medium (C-DSA).We retrospectively evaluated 76 patients (38 males and 38 females,mean age: 65.0?±?14.0 years). They were under hemodialysis and treated with balloon PTA using CO2-DSA or C-DSA at our institution between 2009 and 2016. Mean duration of the follow-up period was 25.59?±?21.45 months.We compared the patency rates obtained after CO2-DSA-based balloon PTA with those after C-DSA-based balloon PTA. Secondary patency, which was defined as the duration of patency after all further endovascular interventions until surgical repair, was considered as the endpoint in this study.Overall, 19 and 57 patients underwent CO2-DSA- and C-DSA-based balloon PTA, respectively. CO2-DSA- and C-DSA-based balloon PTA produced clinical success rates of 100% and 96.5%, respectively. Blood vessel injury occurred in one patient who underwent C-DSA-based balloon PTA. No major complications occurred in CO2 group. At 24 months, the post-PTA secondary patency rates of CO2-DSA- and C-DSA-based balloon PTA were 94.1% and 93.9%,respectively (P?=?.9594).CO2-DSA is safe for hemodialysis patients. Compared with C-DSA, CO2-DSA-based balloon PTA produces have a similar secondary patency rate., Medicine, 99(36), e21890; 2020

Background Posterior cervical pedicle screw (CPS) internal fixation has better biomechanical stability than other posterior cervical fixation methods. However, this technique is limited in clinical practice due to the complex anatomical structure and the adjacent relationship of the cervical pedicle, and the high risk of neurovascular injury. The purpose of this study was to describe a novel subaxial CPS insertion technique assisted by a special angular scale using lateral mass as a reference marker and to evaluate the accuracy of CPS placement and the distribution characteristics of CPS misplacement. Methods A total of 36 patients with subaxial cervical spine diseases who underwent posterior CPS fixation were consecutively selected. The optimal entry point on the posterior surface of the lateral mass was identified on the three-dimensional cervical model reconstructed from preoperative computed tomography (CT) images. The pedicle transverse angle (PTA) and pedicle-lateral mass angle (PLMA) were measured on the transverse and sagittal CT images respectively. The pedicle screws were inserted according to the preoperatively planned entry point and angles. We analysed the postoperative CT images for CPS misplacement rates and perforation directions following the Lee classification. Results Overall, 177 pedicle screws were inserted, of which 119 (67.2%) were classified as grade 0, 43 (24.3%) as grade 1, 12 (6.8%) as grade 2 and 3 (1.7%) as grade 3 by the postoperative CT images. The accuracy rate of CPS placement was 91.5%. Of the 15 misplaced pedicle screws (grades 2 and 3), 11 were lateral pedicle perforations, 3 were superior perforations and 1 was an inferior perforation. There were no neurovascular injuries related to CPS misplacement. Conclusions With our technique, the optimal entry point and two angles (PTA and PLMA) were identified for CPS insertion. The novel CPS insertion technique assisted by a special angular scale provides high accuracy and few complications.

Advancements in the endovascular treatment of femoropopliteal atherosclerotic lesions have led to treatment of more complex lesions, particularly long lesions. The aim of this study was to determine the meta-analytic primary patency and need for re-intervention among patients treated for very long lesions (200 mm) at the femoropopliteal segment and to identify potential risk factors for loss of patency.This study was performed according to the PRISMA guidelines. A random effects model meta-analysis was conducted, and the I-square was used to assess heterogeneity.Fifty-one studies comprised of 3029 patients were included. The mean lesion length was 269 mm. The primary patency rate at 30 days, 6 m, 1-, 2- and 5-years of follow-up was 98%, 76%, 62%, 55%, and 39% respectively. The incidence of TLR was 16% at one year and 32% at two years. The secondary patency rate at 1, 2, 3 and 5 years was 85%, 71%, 64%, and 64% respectively. Heparin bonded ePTFE covered stents (69%) and paclitaxel eluting stents (73%) demonstrated higher 1-year primary patency rates than self-expanding nitinol stents (55%) or uncoated percutaneous transluminal angioplasty (PTA) with provisional stenting (54%). Lesions treated with a heparin bonded ePTFE covered stent had statistically significant higher odds of remaining patent at 1-year of follow-up (OR: 2.74; 95%CI: 1.63-4.61; p 0.001) than lesions treated with BMS or PTA. Patients with long femoropopliteal lesions causing critical limb ischemia (CLI) developed restenosis or occlusion more often than patients treated for claudication (HR: 1.63; 95%CI: 1.06-2.49; p = 0.026) during an average follow-up of 26 months.Primary stenting of femoropopliteal TASC D lesions using drug eluting stents or covered stents results in sustained patency over time. PTA or uncoated nitinol stents demonstrated lower patency rates. However, additional comparative studies are needed to determine the efficacy of newer technologies for the treatment of complex femoropopliteal lesions and provide evidence for the most optimal treatment approach.

[Objectives] To describe the population pharmacokinetics of fosfomycin for patients with bacteraemic urinary tract infection (BUTI). The analysis identified optimal regimens on the basis of pharmacodynamic targets and assessed the adequacy of Clinical and Laboratory Standards Institute (CLSI) and European Committee on Antimicrobial Susceptibility Testing (EUCAST) susceptibility breakpoints for Escherichia coli., [Methods] Data of 16 patients with BUTI caused by multidrug-resistant E. coli (FOREST clinical trial) received intravenous fosfomycin (4 g every 6 hours) were analysed. A population pharmacokinetic analysis was performed, and Monte Carlo simulations were undertaken using 4 g every 6 hours and 8 g every 8 hours. The probability of pharmacodynamic target attainment was assessed using pharmacodynamic targets for E. coli for static effect, 1-log drop in bacterial burden and resistance suppression., [Results] Sixty-four plasma samples were collected over a single dosing interval (day 2 or 3 after starting fosfomycin treatment). Fosfomycin concentrations were highly variable. Pharmacodynamic target attainment analysis showed mild improvement by increasing fosfomycin dosing (4 g every 6 hours vs. every 8 hours). These dosages showed success for decreasing 1-log bacterial burden in 89% to 96% (EUCAST breakpoints) and 33% to 54% (CLSI breakpoints) of patients, but they were unable to reach bacterial resistance suppression targets., [Conclusions] Fosfomycin concentrations are highly variable—a fact partially explained by renal impairment. The present work supports the use of 4 g every 6 hours as an effective regimen for the treatment of non–critically ill patients with BUTI caused by multidrug-resistant E. coli, as higher dosages might increase toxicity but may not significantly increase efficacy. The current information may suggest that fosfomycin susceptibility breakpoints need to be reappraised., Supported in part by the Ministerio de Economía y Competitividad, Instituto de Salud Carlos III (PI13/01282 and PI16/01824), Spain; and by Plan Nacional de I+D+i 2013-2016 and Instituto de Salud Carlos III, Subdirección General de Redes y Centros de Investigación Cooperativa, Ministerio de Economía, Industria y Competitividad, Spanish Network for Research in Infectious Diseases (REIPI RD16/0015/0010; RD16/0016/0001), cofinanced by European Development Regional Fund ‘A way to achieve Europe,’ Operative Program Intelligent Growth 2014–2020. FDP was supported by a VPPIUS fellowship from the University of Seville. WWH was supported by a National Institute of Health Research Clinician Scientist award (CS/08/08).

Background Post transplantation anemia (PTA) is common among kidney transplant patients. PTA is associated with increased graft loss and in most studies with increased mortality. However, the effect of the severity of anemia on this associations was not thoroughly evaluated. Methods Patients who underwent kidney transplantation in Rabin Medical Center (RMC) were included in the study. Data were collected during the years 2002–2016. Anemia was defined as hemoglobin (Hb) level less than 12 g/dL in women and less than 13 g/dL in men, in accordance with World Health Organization (WHO) criteria. Severe anemia was defined as hemoglobin lower than 11 g/dL. Primary outcome was a composite of patient and graft survival. We used univariate and multivariate models to evaluate association between severity and specific causes of anemia with the outcomes. As the risk associated with anemia changed over time we analyzed the risk separately for the early and the late period (before and after 1251 days). Results Our cohort included 1139 patients, 412 (36.2%) of which had PTA and 134 (11.7%) had severe anemia. On multivariable analysis, severe anemia was highly associated with the primary outcome at the early period (HR 6.26, 95% CI 3.74–10.5, p

ObjectiveBuerger’s disease is one of the worst diseases causing peripheral artery occlusions (especially lower extremity) with increased morbidity and mortality. Endovascular treatment of the diseased arteries gains preference over bypass surgery nowadays. Here, we aimed to present the clinical outcomes of 16 consecutive Buerger’s disease patients underwent extended endovascular recanalization which is a new technique to restore direct blood flow to at least one foot artery, with the performance of angioplasty for each tibial and foot artery obstructions.MethodsA total of 16 consecutive patients with confirmed diagnosis of Buerger’s disease that percutaneously treated in our center between February 2014 and March 2018 were included in the study. The mean age of the patients was 44.25 ± 4.28 ranging from 36 to 50 years. After physical examination and complementary diagnostic tests, performance of extended angioplasty for occluded arteries was intended to restore direct blood flow to at least one of the blow-the-knee arteries.ResultsA successful extended endovascular treatment was performed in 20 of 22 limbs, achieving a technical success of 91%. All patients were successfully discharged without any complication. Mean follow-up duration was 21.43 ± 7.08 months. Reintervention was performed in one patient and minor amputation was needed in one of the failed limbs. Limb salvage rate was 100%. A significant difference was observed based on Rutherford classification, ankle brachial index, direct blood flow to foot, presence of ulcer and rest pain when compared before and after the intervention.ConclusionWe showed successful extended endovascular recanalization of Buerger’s disease patients with a high technical success rate and sustained clinical improvement. Extended endovascular recanalization could be a therapeutic option in Buerger’s disease patients, since they are not good candidates for surgery.

Background and Purpose: Subgroup analysis of the SAMMPRIS trial showed a higher rate of periprocedural perforator strokes with the Wingspan stent in the basilar artery in patients with symptomatic intracranial atherosclerotic stenosis (ICAS). It remains unclear whether angioplasty (PTA) alone or in combination with other stent types (PTAS) will yield similar results in perforator-bearing segments of the anterior and posterior circulation. Methods: We retrospectively analyzed the periprocedural complication rate, long term outcome and stroke etiology in 59 consecutive patients with ICAS of the middle cerebral artery (79 treatments) and 67 patients with ICAS of the intracranial vertebral and basilar artery (76 treatments) treated with PTA or PTAS from 2007 to 2015 in a high-volume neuro-interventional center. Results: Periprocedural symptomatic ischemic strokes occurred significantly more often in patients with posterior vs. anterior ICAS treatment (14.5 vs. 5.1%, p = 0.048). During a mean follow-up period of 19 (±23.7) months, 5 recurrent ischemic and 2 hemorrhagic strokes (10.4%) occurred in the territory of the treated artery in posterior circulation compared to 2 ischemic strokes in the anterior circulation (3.4%, p = 0.549). Overall, significantly more patients treated for a posterior ICAS suffered a periprocedural or follow-up stroke [25% vs. 11.4%, p = 0.024]. Periprocedural ischemic strokes were predominantly perforator strokes (73.3%), while all ischemic strokes during follow-up were caused by distal embolization (57.1%) or delayed stent occlusion (42.9%). There was no difference between PTA alone and PTAS. Conclusion: The periprocedural and long-term symptomatic stroke rate was significantly higher in the treatment of perforator-bearing arteries in the posterior circulation. There was no difference between PTA alone or PTAS.

INTRODUCTION Interpersonal communication, day to day activities, learning language and acquiring grades in the school are important parts in the life of school going children. Unilateral or bilateral Loss of hearing affects education and the child feels handicapped socially, emotionally, and scholastically. Such children lose grades and retained in the same class affecting them emotionally. The present study was conducted in order to find out the various causes of unilateral Sensorineural Hearing Loss (USNHL) in children and to study role of various audiological findings in diagnosing the cause of impaired hearing in children. AIMS AND OBJECTIVES To find out the possible etiological causes and study the role of various audiological tests in finding the causes of unilateral impaired hearing in children. MATERIALS AND METHODS A prospective study was conducted in the Department of ENT of a tertiary Hospital attached to a Medical College in Warangal, Telangana. A total of 346 children aged between 4 and 15 years attended presenting with complaints of impaired hearing. Among them 73 children with unilateral sensorineural deafness were included in the study. After a thorough ENT examination subjective tests like pure tone audiometry and behavioral observation audiometry and objective tests like impedance audiometry, Oto-acoustic emissions (OAE), and brainstem evoked response audiometry (BERA) were performed. RESULTS While identifying the possible etiological cause of USNHL, OAE revealed 56.16% REFER and 43.83% PASS results. Impedance audiometric results showed 71.22% as Type A Tympanogram. Pure tone audiometric results were mostly showed severe and profound hearing losses together accounting to 87.66%. BERA findings were mostly on severe and profound hearing loss (90.40%). No children with syndromic or cranio-facial abnormalities were found. CONCLUSIONS A prospective Hospital based study of school children with USNHL showed acquired nature of the condition with moderate to severe hearing loss. No accompanying syndromic or cephalo-facial anomalies were noted as the cause of USNHL.

Objective To investigate the early detection of the damage of cochlear activity by using distortion product otoacoustic emissions (DPOAE) (DP-gram) comparing to the results of the impedance audiometry. Methods We examined 53 patients including 43 hemodialyzed patients, and 10 controls. First it was applied a tympanometry, and then in normal results we applied impedance audiometry and DPOAE (DP-gram). Results We found sensorineural hearing loss in 67% of audiometric results of the hemodialyzed patients and there was a decrease of the DPOAE amplitude in 77% of hemodialyzed patients. In the control group there was one patient (10%) with neurosensorial in high frequencies hearing loss in both measurements with audiometry and DPOAE. Conclusions There is a sensorineural hearing loss observed in most of the patients with chronic renal failure. DPOAE audiogram shows lower amplitudes than impedance audiometry and it can be used for the early detection of cochlear damage.

INTRODUCTION: Age Related Hearing Loss (ARHL) is defined as loss of hearing in elderly persons not influe nced by the extraneous factors like noise trauma etc or intrinsic like CVS related diseases or endocrinal disorders like Diabetes. Also termed as Presbycusis it is defined as the loss of hearing due to age related changes taking place in the auditory syste m starting from the pinna to the cortical centers in the brain. It does not include any other factor contributing or initiating the pathological changes in the auditory system resulting in hearing loss. All these changes in the tissues are not pathological but truly age related. The threshold of hearing is defined as the pure tone average across the frequencies of 0.5 to 8 kHz. The severity of hearing loss is graded as profound hearing loss : more than 90dB , severe to severe loss : 71 - 90 dB or more ; Moderate to severe hearing loss : 56 - 70 , Moderate hearing loss : 41 - 55 dB HL ; Mild hearing loss : 26 - 40 dB HL. Present study is to evaluate hearing loss in persons aged above 65 years both of those attending the Hospital for loss of hearing and those screened in a sur vey. AIM: To evaluate the hearing thresholds in individuals aged above 65 years attending the Government General Hospital and among the people attending the hearing screening done in the city of Warangal. The study also includes the review of the literature on ARHL. MATERIALS AND METHODS: 185 individuals aged above 65 years are evaluated for hearing thresholds with the help of pure tone audiometry and speech audiometry. Among the 185 individuals 102 are patients attending the Department of ENT for the compla ints of loss of hearing. The remaining 83 individuals are from the survey conducted to screen for hearing loss in the city of Warangal for the population aged above 65 years. Demographic data about the 185 individuals is collected. Pure tone audiogram and speech audiometry is done in all the patients. CONCLUSIONS: PTA and SRT values are similar in both the groups. Early old age groups presented with mild to severe types of deafness and loss in lower frequencies. Late old aged people showed profound hearing l oss and increased thresholds in higher frequencies. SRT estimation seemed more sensitive than calculating PTA in the persons above 85 years. Females showed 5 to 10 dB lower PTA values than males in all ages.

To report our experience in treating severely claudicant patients, employing a “nitinol-constrained” balloon (Chocolate, TriReme Medical Inc., Pleasanton, CA—USA) before drug-coated balloon (DCB) in a standardized protocol. Eighty-one (84 limbs) consecutive Rutherford category (RC) 3 patients treated between December 2014 and December 2016 for superficial femoral artery (SFA) and popliteal arterial (PA) disease by nitinol-constrained balloon followed by DCB were enrolled. Bailout stenting was performed by Zilver PTX implantation. Intraoperative technical success and bailout-stenting rates were assessed as well as clinical improvement, ankle-brachial index (ABI) modification, primary patency (PP), and secondary patency (SP) rates at follow-up. Sixty-eight patients (83.9%) were male and 31 (38.2%) diabetics. Fifty-five limbs (65.5%) presented occlusion (CTO); in 18 limbs CTO was longer than 150 mm. Bailout stenting rate was 9.5% (8/84). All patients completed 30-day follow-up: PP 100%, 61 patients completely asymptomatic (RC = 0). Mean follow-up was 12.3 ± 5.6 months; overall PP was 98.8%, and SP was 98.8%. At mid-term analysis, no differences in outcomes were recorded between stenosis and CTOs with a PP of 96.5 and 96%, respectively (p = 0.725). CTO length impacted early results: in cases of CTOs 150 mm, it was 83.3% (p = 0031). ABI at 12-month was significantly higher with respect to preoperative values (p

PURPOSE: To identify possible risk factors in predicting clinical outcome in critical limb ischemia (CLI) patients undergoing percutaneous transluminal angioplasty (PTA).MATERIALS AND METHODS: PubMed and EMBASE were searched for studies analyzing CLI and clinical outcome after PTA from January 2006 to April 2017. Outcome measures were ulcer healing, amputation free survival (AFS)/limb salvage and overall survival. Data on predictive factors for ulcer healing, AFS/limb salvage and survival were extracted.RESULTS: Ten articles with a total of 2448 patients were included, all cohorts and based on prospective-designed databases. For ulcers, it seems that complete healing can be achieved in most of the patients within 1 year. No significant predictive factors were found. AFS/limb salvage: AFS rates for 1, 2 and 3 years ranged from 49.5 to 75.2%, 37 to 58% and 22 to 59%, respectively. Limb salvage rates for 1, 2 and 3 years ranged from 71 to 95%, 54 to 93.3% and 32 to 92.7%, respectively. All studies had different univariate and multivariate outcomes for predictive factors; however, age and diabetes were significant predictors in at least three studies. Survival: Survival rates for 1, 2 and 3 years ranged from 65.4 to 91.5%, 45.7 to 76% and 37.3 to 83.1%, respectively. Different predictive factors were found; however, age was found in 2 out of 5 studies reporting on predictive factors.CONCLUSIONS: In several studies two factors, age and diabetes, were found as predictive factors for AFS/limb salvage and survival in patients with CLI undergoing PTA. Therefore, we believe that these factors should be taken into account in future research.LEVEL OF EVIDENCE: Level 2a.

Introduction Treatment of deep venous occlusive disease is gaining popularity, although the results and outcomes of various techniques are yet to be fully studied. Quality-of-Life (QoL) improvement is a valid and important outcome in medicine, but no specific QoL instruments for deep venous pathology exist up until now. We assessed the short term QoL effects of treated patients with post thrombotic syndrome after deep venous occlusion. Materials and methods Patients with proven venous occlusive disease referred to the outpatient clinic of our department of Venous Surgery in the Maastricht University Medical Centre were included. After inclusion, patients were treated by PTA and stenting and when indicated an endophlebectomy was performed and an AV fistula was made. QoL was assessed with the disease specific VEINES-QOL/Sym and the generic SF-36 questionnaires preoperatively at baseline and postoperatively at 3 and 12 months. Results 61 patients completed the 3 month follow-up period and 28 patients the 12 month follow-up period. VEINES-QOL and Sym scores improved after 3 months: 17.5 points for QOL (p = Conclusions Treating deep venous occlusive disease leads to short-term improvement of both disease specific QoL as well as generic QoL scores. Larger long-term follow-up studies are needed to corroborate these results.

The aim of this study was to explore the effects during 12 months follow-up of 12 weeks of supervised exercise therapy (SET) after percutaneous transluminal angioplasty (PTA) compared to PTA alone on physical function, limb hemodynamics and health-related quality of life (HRQoL) in patients with intermittent claudication. Fifty patients were randomised to an intervention or a control group. Both groups received usual post-operative care and follow-up measurements at three, six and 12 months after PTA. The intervention group performed 12 weeks of SET after PTA. The control group did not receive any additional follow-up regarding exercise. During the 12 months’ follow-up, the members of the intervention group had significantly better walking distance than the control group. The intervention group had a significantly higher HRQoL score in the physical component score of the SF-36, and the domains of physical function, bodily pain and vitality. For limb hemodynamics, there was a non-significant trend towards better results in the intervention group compared to the control group. Conclusion: SET after PTA yielded statistically significantly better results for walking distance and HRQoL in the intervention group than the control group during the 12 months of follow-up.

Background: Endovascular treatments such as percutaneous transluminal angioplasty (PTA) and stent placements are becoming the standard method in managing haemodialysis access failure. Venous rupture is the most common complication during endovascular procedures. Complications during endovascular treatments of central venous stenosis or occlusion have been rarely reported. Objectives: To investigate the incidence and management of central vein rupture while performing PTA for central vein stenosis or occlusion in haemodialysis patients. Method: Between 1998 and 2013, PTA was performed using various techniques in haemodialysis patients for central vein stenoses ( n = 2437) and occlusions ( n = 666). When the guide wire passed through the stenosis or the occlusion, PTA was performed regardless of the presence of a venous rupture. The incidence of central vein rupture was analysed using the chi-square test according to the gender, location, right versus left, presence of thrombosis and stenosis versus occlusion. Percutaneous management of central vein rupture was also evaluated. Results: Central vein rupture occurred in 12 cases (0.39%). All ruptures occurred in the cases with occlusion. Only stenosis versus occlusion reflected a significant correlation ( p < 0.001) with central vein rupture. Central vein ruptures were managed by low-pressure balloon tamponade ( n = 2), stent/stent-graft ( n = 5) and balloon-mediated haemostasis blocking venous inflow followed by the observation ( n = 5). Conclusion: Central vein rupture is a rarely occurring complication while performing PTA for central vein stenosis and occlusion, and the majority can be successfully managed by percutaneous techniques.

Audience: The Bubble-Wrap Peritonsillar Abscess Model is designed to instruct PGY 1-4 Emergency Medicine residents as well as Emergency Medicine-bound students. Introduction: Peritonsillar Abscesses (PTA) are frequently encountered in clinical practice. Emergent ENT consultation may not be possible. Emergency physicians must be able to perform needle aspiration of PTA. This procedure is fraught with risk due to the natural proximity of the internal jugular vein and carotid artery to the pharyngeal tonsils. Deliberate practice of clinical procedures can drastically reduce associated complications (Okuda et al., 2009); however, no simulators are available for this particular purpose. Here we describe a PTA model that can be used to practice PTA drainage by novice learners. Objectives: The basic purpose of the bubble-wrap PTA model is to teach learners competency in the needle aspiration of peritonsillar abscesses. Method: This model uses bubble wrap, zip ties, chicken broth and liquid latex to simulate a peritonsillar abscess. Learners are then able to perform a needle aspiration of the simulated abscess from start to the end with no risk to a live patient.

Introduction Many practitioners express concern about the adequacy of imaging using CO2 in the lower extremities, particularly in the distribution of the popliteal artery and below (5) . Published results have varied considerably with respect to the validity of imaging this anatomy. Objectives Review our experience with CO2 angiography using CO2 angioset in evaluation and intervention of below knee arteries. Patients and methods Forty patients with lower limb ischemia were divided into two groups. The 1st group has normal kidney function, subjected to angiography with CO2 and water soluble contrast media (WSCM) as the reference standard (control). The 2nd group has subjected only to CO2 angiography due to one or more risk factors related to WSCM. CO2 angioset is a dedicated CO2 injection system used in all patients. In the 1st group; imaging findings on CO2 and WSCM angiography were compared while in the 2nd group; findings were compared with the post procedure clinical and color Doppler findings. Results All arterial lesions detected on CO2 angiography were comparable to those obtained with WSCM in the control group. In the 2nd group; post procedure clinical and Doppler findings correlated well with angiographic findings and angioplasty results. CO2 angiography images have lower resolution compared to WSCM however, they were reliable for accurate diagnosis and to guide angioplasty. Conclusion CO2 angiography using CO2 angioset is considered a reliable alternate to WSCM in assessment of below knee arteries and provides a reliable roadmap to interventional procedures.

INTRODUCTION Treatment of carotid stenosis could be surgical: eversion endarterectomy, conventional endarterectomy and patch-plasty, resection with graft interposition and bypass procedure or, in the past few years, carotid artery angioplasty (PTA) with stent implantation. OBJECTIVE The aim of this study is to present early results of carotid artery angioplasty and stenting, as well as to identify indications for this procedure. METHOD Twenty-three patients with stenosis of internal carotid artery were included in the prospective study which was performed in the period from July 2006 to July 2007. For PTA and stenting of the carotid artery we used Balloon dilatation catheter Ultra-softTM SV and Carotid WallstentTM MonorailTM. During the procedure, brain protection by embolic protection system Filter Wire EZ was essentially performed. Descriptive statistical methods were performed to present and describe the patient characteristics, risk factors and results. RESULTS 23 patients were examined. In four (17.39%) cases there was asymptomatic, while in 19 (82.61%) there was symptomatic homodynamic significant stenosis of the internal carotid artery. Four of these 19 patients (17.39%) had late restenosis following carotid endarterectomy, four (17.39%) important respiratory failure, and 11 (47.83%) important heart disease. Patients were followed up for the first 30 postopertive days. In that period, there were no mortality and no needs for surgical conversions. In one case (4.35%), residual stenosis of 30% remained. Two patients (8.70%) had TIA and one (4.35%) had CVI. CONCLUSION Main indications for PTA and stenting of carotid arteries are: surgically inaccessible lesions (at or above C2; or subclavial); radiation-induced carotid stenosis; prior ispilateral radical neck dissection; prior carotid endarterectomy (restenosis), severe cardiac and pulmonary conditions. Limitations and contraindications to carotid angioplasty and stentning include: significant peripheral occlusive diseases; unfavorable aortic arch anatomy; severe tortuosity of the common and internal carotid artery; severely calcified stenosis, lesions containing fresh thrombus; stenosis longer than 2 cm; critical (>99%) stenosis; associated carotid artery aneurysm; contrast-related issues and severe aortic valve stenosis.

Procedures used in treatment of carotid stenosis are endarterectomy, PTA with stent implantation, resection with graft interposition and by-pass procedure. Segmental lesions are found more often and treated by the first two mentioned procedures. In case of longer lesions and extension to the greater part of the common carotid artery, the other two procedures are performed. For the past few years, the main dilemma has been whether to perform carotid endarterectomy or PTA with stent implantation. Both early and long-term results speak in favour of carotid endarterectomy, regardless of an increased number of PTA and carotid stenting. At the same time, PTA and carotid stenting are more expensive procedures. Both methods have their defined and important roles in treatment of segmental occlusive carotid lesions. Severe cardiac, pulmonary and renal conditions, which increase the risk of general anaesthesia, are not an absolute indication for PTA and stenting, since endarterectomy can be done in regional anaesthesia. Main indications for PTA with stent implantation are: surgically inaccessible lesions (at or above C2; or subclavian); radiation- induced carotid stenosis; prior ipsilateral radical neck dissection; prior carotid endarterectomy (restenosis).

Aim: to evaluate the results of transluminal angioplasty (PTA) performed through infrainguinal bypass grafts for stenotic or occlusive lesions at the distal anastomosis and/or in the runoff arteries. Design: retrospective clinical study. Material and methods: forty-one patients underwent 57 procedures at the distal anastomosis (n=13), in the runoff arteries (n=32) or at both locations (n=12) at a median of 9.6 months (range, 2–76 months) after infrainguinal bypass grafting. Nineteen procedures were on the popliteal artery, the rest on the crural arteries. Eleven procedures related to occlusions less than 5 cm in length. Results: technical success was achieved in 91%. Primary and primary assisted graft patency rates at 3 years were 32% and 53%, respectively. There were no significant differences in patency rates with regard to the graft material, the type of lesion, the level of PTA, the status of runoff and the use of thrombolysis before PTA. No patients underwent amputation as a direct consequence of failed PTA or graft occlusion. One patient underwent acute surgical intervention due to graft occlusion at the time of attempted PTA. Conclusion: the results of PTA at the distal anastomosis and/or in the runoff arteries in limbs with infrainguinal bypass seemed to be inferior to the results of surgical revisions reported in literature. However, as failed PTA did not jeopardise vein-patch angioplasty or jump grafting, it is a reasonable alternative to surgical intervention in selected cases.

We sought to assess the frequency and predictors of early and late posttransplantation anemia (PTA). In addition, we aimed to assess the outcomes of patients with anemia and to assess the impact of anemia on mortality, graft function, and graft failure. Patients who underwent kidney transplantation in a single center during a 4-year period were included. Predictors associated with the development of anemia at 6 months (early PTA) or 2 years (late PTA) were evaluated in a univariate and multivariate analyses. The effects of anemia and other variables on mortality and graft function were assessed. A total of 266 kidney transplant recipients were included. The prevalence of PTA at 6 months (early PTA) was 51.3% and at 2 years (late PTA) was 36.6%. Female sex was significantly associated with early PTA. Patients with early PTA proceeded to late PTA. Patients with both early and late PTA had a higher mortality rate at 4 years compared to patients without anemia. On multivariable analysis, lower Hb at 2 years posttransplantation (hazard ratio [HR] 0.716, 95% confidence intervals [CI] 0.541–0.948, for every increment of 1 g/dL) was significantly associated with mortality. Patients with late PTA suffered a decline in eGFR compared to patients without anemia (P = .026). Furthermore, a lower Hb at 2 years posttransplantation was also associated with graft failure (HR 0.775, 95% CI 0.619–0.969, for every increment of 1 g/dL). Post-transplantation anemia is significantly associated with late mortality, with a decline in graft function and with an increased incidence of graft failure.

Concetta De Pasquale,1,2 Maria Luisa Pistorio,1 Massimiliano Veroux,2 Alessia Giaquinta,2 Pierfrancesco Veroux,2 Michele Fornaro11Department of Education Science, University of Catania, Catania, Italy; 2Vascular Surgery and Organ Transplant Unit, Department of Surgery Transplantation and Advanced Technologies, University Hospital of Catania, Catania, ItalyBackground: Multiple sclerosis (MS) is a disease of the nervous system that has profound effects on everyday functioning and quality of life of not only the person who is diagnosed, but also her/his family and acquaintances. Despite this, the uncertainties of the actual etiological basis of MS make it difficult to reach a conclusive statement about the optimal therapeutic management of the disease, which may differ depending on the given case and phase of illness. This has led to an interest in potential novel therapeutic avenues, including percutaneous transluminal angioplasty (PTA). Yet, evidence in support of PTA in the management of MS is scarce and contradictory. The aim of the present study was to provide a preliminary assessment as to whether PTA may impact subjective quality of life and cognitive functioning in severe MS. Method: Ninety-five MS outpatients were followed-up for 24months on a scheduled basis using the Milan Overall Dementia Assessment and the short-form 36-item scales, and were clinically evaluated by an appointed neurologist and psychiatrist. Results: At end point (month 24), only a minority of patients were still active in the study (n=33or 34.74%). Among other measures, those who remained in the study until completion showed a significantly better Expanded Disability Status Scale and Milan Overall Dementia Assessment autonomy profile at study entrance compared to those patients who did not remain in the study until completion. Limitations were: a lack of any active control group; small sample size; Berkson’s bias; and selection by indication biases.Conclusion: Given the burden of MS and its high attrition rate, additional studies, including bigger samples, active control groups, and Cox’s regression and survival analysis in case of randomization, should shed further light on the actual usefulness of PTA for the most severe cases of MS.Keywords: CCSVI, chronic cerebrospinal venous insufficiency, PTA

Objectives to study the inflammatory response to balloon angioplasty (PTA). Design prospective study. Materials blood samples were drawn for cytokine analysis from 10 patients undergoing PTA before, after 60 min and 6 h after the balloon inflation. Adhesion molecules were analysed in 14 patients undergoing PTA and in seven patients undergoing angiography only. Arterial samples were taken in eight patients, before PTA, immediately after and 15 min later. Venous samples were taken in six patients and in the group undergoing angiography only. The sampling was before, 60, 90 and 120 min after the procedure. As controls served 15 patients with no signs of peripheral arterial disease. Methods cytokines (IL-6, TNF-α) were analysed using ELISA. Adhesion molecule expression on WBC was measured by flow cytometry. Results a significant increase of IL-6 in the sample taken 6 h after the last balloon inflation was seen in five patients. TNF-α was raised only in one patient. The group of patients with peripheral arterial occlusive disease (PAOD) expressed pre-interventionally a higher level of adhesion molecules on WBC compared to the controls. The expression of adhesion molecules (CD11b/CD18) was significantly decreased after PTA. Conclusions only a very limited cytokine response is caused by PTA reflecting the small surgical trauma. PTA results in a downregulation of detectable CD11b/CD18 expression on WBC in the circulation, which may reflect removal of activated cells through adhesion and extravasation.

Objective to evaluate the role of a combined percutaneous endovascular approach including thrombus aspiration, catheter thrombolysis, and percutaneous transluminal angioplasty (PTA) to treat acute and subacute occlusions of native leg arteries. Materials and methods retrospective evaluation of the effectiveness and safety of this catheter therapy in 89 consecutive patients (93 legs) in a single centre. Results treatment was initially successful in 90% of legs. Mortality at 30 days was 8%, and at 12 months 19%. Amputation-free survival at 12 months was 78%. Aspiration alone was sufficient in 31% of cases, urokinase (mean dose 112 500±55 900 IU) was used in 22%, PTA was added in 69%. There was no major bleeding except for one false aneurysm treated by ultrasound-guided compression. Secondary interventions within 12 months were required in 30% of cases (14 endovascular, 16 open surgical procedures).Conclusions catheter thrombus aspiration in combination with thrombolysis and/or PTA is highly effective. Only in a minority of patients are thrombolytics in modest doses necessary, and serious bleeding complications are rare. We recommend this procedure as first-line treatment for acute or subacute infrainguinal arterial occlusions.

Objectives: To evaluate whether revascularisation has any influence on the mortality rate, and the impact of old age in patients with critical limb ischaemia (CLI). Design: Analysis of Swedish Vascular Registry (Swedvasc) data. Patients and methods: During 1987–1995, 3730 surgical and 1199 endovascular (PTA) procedures below the groin due to CLI were reported. At 1 year three groups were defined: “occluded, amputated”; “occluded, not amputated” and “patent”. Survival was also calculated. Clinical outcome at 1 month and at 1 year was defined as: patient “alive, improved”, “alive, not improved”, “alive, amputated” and “dead”. Two age groups: ≤75 years or and ≥76 years were compared. Results: The mortality rate for the whole group was 5.3% at 1 month and 22.9% at 1 year, with no difference between the Surgery and PTA groups. Significantly more patients were alive and improved after surgery than after PTA at 1 month (82.3% vs. 77.7%) and at 1 year (49.6% vs. 44.3%). The amputation rate was 5.6% at 1 month and 14.4% at 1 year; 17% for diabetics. After surgery, the cumulative mortality rate did not differ between patients with a salvaged limb, irrespectively of patency of the re-construction, but was significantly higher after amputation. After PTA, only a reconstruction reported as patent was linked to the most favourable survival rate. The older patient group had a mortality rate of 6.4% at 1 month and 26.4% at 1 year, significantly higher than the younger group (3.8% and 17.6%, respectively). The amputation rate did not differ according to age. Significantly more patients were alive but not improved in the older group. Conclusions: The outcome of surgery vs. PTA was similar regarding survival and amputation, but surgery resulted in a greater improvement although this might be due to selection. Older patients and those with an amputation had higher mortality rates.

The thickening of the vessel wall (intimal hyperplasia) is a pathological process which often follows re-vascularization approaches such as transluminal angioplasty and artery bypass graft, procedures used to re-vascularize stenotic artery. Despite the significant improvements in the treatment of intimal hyperplasia obtained in the last years, the problem has not completely solved. Nucleic acid based-drugs (NABDs) represent an emergent class of molecules with potential therapeutic value for the treatment of intimal hyperplasia. NABDs of interest in the field of intimal hyperplasia are: ribozymes, DNAzymes, antisense oligonucleotides, decoy oligonucleotides, small interfering RNAs and micro interfering RNAs. These molecules can recognize, in a sequence-specific fashion, a target which, depending on the different NABDs, can be represented by a nucleic acid or a protein. Upon binding, NABDs can down-modulate the functions of the target (mRNA/proteins) and thus they are used to impair the functions of disease-causing biological molecules. In spite of the great therapeutic potential demonstrated by NABDs in many experimental model of intima hyperplasia, their practical use is hindered by the necessity to identify optimal delivery systems to the vasculature. In the first part of this review a brief description of the clinical problem related to intima hyperplasia formation after revascularization procedures is reported. In the second part, the attention is focused on the experimental evidences of NABD therapeutic potential in the prevention of intimal hyperplasia. Finally, in the third part, we will describe the strategies developed to optimize NABD delivery to the diseased vessel.

This review outlines risk factors of post-laser in situ keratomileusis (LASIK) ectasia that can be detected preoperatively and presents a new metric to be considered in the detection of ectasia risk. Relevant factors in refractive surgery screening include the analysis of intrinsic biomechanical properties (information obtained from corneal topography/tomography and patient's age), as well as the analysis of alterable biomechanical properties (information obtained from the amount of tissue altered by surgery and the remaining load-bearing tissue). Corneal topography patterns of placido disk seem to play a pivotal role as a surrogate of corneal strength, and abnormal corneal topography remains to be the most important identifiable risk factor for ectasia. Information derived from tomography, such as pachymetric and epithelial maps as well as computational strategies, to help in the detection of keratoconus is additional and relevant. High percentage of tissue altered (PTA) is the most robust risk factor for ectasia after LASIK in patients with normal preoperative corneal topography. Compared to specific residual stromal bed (RSB) or central corneal thickness values, percentage of tissue altered likely provides a more individualized measure of biomechanical alteration because it considers the relationship between thickness, tissue altered through ablation and flap creation, and ultimate RSB thickness. Other recognized risk factors include low RSB, thin cornea, and high myopia. Age is also a very important risk factor and still remains as one of the most overlooked ones. A comprehensive screening approach with the Ectasia Risk Score System, which evaluates multiple risk factors simultaneously, is also a helpful tool in the screening strategy.

Background: Transradial access reduces the incidence of access site complications of percutaneous revascularization procedures. However, in patients with peripheral vascular disease, the adoption of transradial approach for superficial femoral artery (SFA) angioplasty is usually prevented by the distance between the vascular access and the target lesions; thus, SFA angioplasty is commonly performed by transfemoral approach. Recently, low-profile balloons with extended shaft length became available, allowing to potentially address SFA lesions by transradial approach. As plain balloon angioplasty represents a valuable option for SFA in-stent restenosis treatment, we evaluated the feasibility of transradial approach in this clinical setting. Methods: Transradial balloon angioplasty of SFA diffuse in-stent restenosis was attempted in 12 patients aged 69.4 ± 5.1 years. Six-French 125 cm long MP guiding catheters, 300 cm long 0.018″ guidewire, and low-profile 4 Fr compatible 180 cm long shaft balloons (5 and 6 mm in diameter and 80–150 mm in length) were used. Results: The procedural success was 100%, and no complications occurred during the hospital stay. Compared with a matched group of patients in whom angioplasty was performed by trans-femoral approach, main procedural key data resulted similar except for the amount of administered contrast dye, which was slightly but significantly lower in transradial group (170 ± 59 ml vs. 241 ± 103, P = 0.03). Conclusions: In conclusion, with the currently available equipment, the transradial approach is feasible and represents a valuable alternative for treatment of patients with SFA in-stent restenosis. © 2009 Wiley-Liss, Inc.

Objectives To investigate the impact of clinical risk factors, plasma homocysteine and haemostatic variables on the results after endovascular treatment of symptomatic atherosclerosis of the common iliac artery. Design Prospective observational study. Setting University hospital. Patients and method The study included 139 technically successful interventions in 103 patients. Technical success was defined as ≤30% residual stenosis as seen on the post treatment angiogram. Blood samples for analyses of fasting plasma values of homocysteine, fibrinogen, D-dimer, activated protein C resistance were drawn upon admission. Median follow-up for all procedures was 22 months (range 0–55 months). Patency was defined as freedom from ≥50% restenosis or reocclusion. Results The technical success rate for all procedures was 93%. The 1-year cumulative primary patency rate based on intention to treat was 85%. Multivariate analysis revealed a significant independent association between patency rates and levels of fibrinogen and homocysteine and the nature of the lesion treated (stenosis vs. occlusion). Conclusion The aetiology of restenoses and reocclusions is probably multifactorial. Procoagulant activity, the nature of the lesion treated and homocysteine levels within and above the upper range of normal limits are important risk factors for failure after endovascular treatment of the common iliac arteries.

Background To evaluate the therapeutic value of endovascular techniques for the treatment of profunda femoris artery obstructive disease (PFAOD) in critical limb ischaemia (CLI) patients, with technically demanding open profunda repair. Design Retrospective study of prospectively collected data of 15 consecutive CLI patients with technically demanding surgical treatment of PFAOD, that were treated by endovascular means in two European Centers of Vascular Surgery. Materials All patients had critical limb ischaemia with a history of at least two previous vascular reconstructions in the ipsilateral groin and severe co-morbid conditions. All patients had good common femoral artery flow, long occlusion of the superficial femoral and popliteal arteries and impairment of crural arteries. Methods Twelve patients underwent balloon angioplasty alone and, in the other three cases, an additional stent placement was necessary, due to flow-limiting dissection. The follow-up (mean 29.2 ± 10 months) included a surveillance protocol with the best medical treatment and duplex scanning at 1, 3, 6, 12 months and yearly thereafter. Results The endovascular approach was technically successful in all cases and the procedure-related morbidity and mortality rates were 0% for the entire follow-up period. The 3-year primary and secondary patency rates of the treated segment were 80% and 86.7%, respectively. The limb salvage rate was 93.3%. Conclusions The outcome of our series underscores the therapeutic value of balloon angioplasty in cases of severe PFAOD, as bailout treatment in critical limb ischaemia patients with technically demanding open profunda repair. This procedure can be repeated easily if significant restenosis occurs and provides a useful tool in selected cases.