Subjective Clinical Improvement Research Articles

A pilot clinical trial of oral tetrahydrouridine/decitabine for noncytotoxic epigenetic therapy of chemoresistant lymphoid malignancies

One mechanism by which lymphoid malignancies resist standard apoptosis-intending (cytotoxic) treatments is genetic attenuation of the p53/p16-CDKN2A apoptosis axis. Depletion of the epigenetic protein DNA methyltransferase 1 (DNMT1) using the deoxycytidine analog decitabine is a validated approach to cytoreduce malignancy independent of p53/p16. In vivo decitabine activity, however, is restricted by rapid catabolism by cytidine deaminase (CDA). We, therefore, combined decitabine with the CDA-inhibitor tetrahydrouridine and conducted a pilot clinical trial in patients with relapsed lymphoid malignancies: the doses of tetrahydrouridine/decitabine used (∼10/0.2 mg/kg orally (PO) 2×/week) were selected for the molecular pharmacodynamic objective of non-cytotoxic, S-phase dependent, DNMT1-depletion, guided by previous Phase 1 studies. Patients with relapsed/refractory B- or T-cell malignancies (n = 7) were treated for up to 18 weeks. Neutropenia without concurrent thrombocytopenia is an expected toxicity of DNMT1-depletion and occurred in all patients (Grade 3/4). Subjective and objective clinical improvements occurred in 4 of 7 patients, but these responses were lost upon treatment interruptions and reductions to manage neutropenia. We thus performed parallel experiments in a preclinical in vivo model of lymphoma to identify regimen refinements that might sustain DNMT1-targeting in malignant cells but limit neutropenia. We found that timed-alternation of decitabine with the related molecule 5-azacytidine, and combination with inhibitors of CDA and de novo pyrimidine synthesis could leverage feedback responses of pyrimidine metabolism to substantially increase lymphoma cytoreduction but with less neutropenia. In sum, regimen innovations beyond incorporation of a CDA-inhibitor are needed to sustain decitabine DNMT1-targeting and efficacy against chemo-resistant lymphoid malignancy. Such potential solutions were explored in preclinical in vivo studies.

Incidental lowering of otitis-media complaints in otitis-prone children during COVID-19 pandemic: not all evil comes to hurt.

Given COVID-19 pandemic periodic outpatient assessment of otitis-prone children regularly followed at our tertiary outpatient clinic of upper respiratory tract infections was discontinued since 9 March. In order to avoid leaving the patients to themselves just during the winter months, which are the most critical ones for these children, we kept in touch with the families of 102 children (mean age 41.4 ± 14.0 months) who had had a follow-up visit scheduled during the lockdown, and compensated with telemedicine assessment. This incidentally leads to the unexpected but not at all negative finding that a consistent clinical improvement had been occurred in most (82.3%) of children. A statistically significant reduction in the mean number of documented acute otitis media episodes, otorrhea episodes, and systemic antibiotic treatments during the February–April 2020 period compared with February–April 2019 was attested. Clinical evaluation performed in 27.4% cases revealed normal middle ear findings in all but three (89.3%) children.Conclusion: Our data document a global improvement of otitis-prone children in Milan during the Italian lockdown, as a fortuitous and incidental positive effect of the national lockdown.What is Know:• During COVID-19 pandemic in Italy any non-urgent medical activity including periodic outpatient assessment of otitis-prone children was discontinued.• Otitis-prone children experience acute infectious exacerbations mainly in winter.What is New:• Most of children reached by means of a telemedicine assessment during lockdown experienced a subjective clinical improvement; clinical assessment at the end of the lockdown revealed normal otoscopic findings in most cases.• Exceptional circumstances during COVID-19 pandemic had a fortuitous positive effect on otitis-prone children’s clinical conditions.

Sarcoid-like granulomatous orbitopathy-presentation, systemic involvement and clinical outcome.

To describe patients with sarcoid-like granulomatous orbitopathy (SLGO), the rate of known and subsequent systemic sarcoidosis, and the treatment and outcome for the condition. Retrospective review of patients with SLGO presenting between 1990 and 2018, excluding solely lid or lacrimal drainage disease. Sixty-one patients (45 female; 74%) were identified, 54 having biopsy-proven sarcoidosis (47 orbital, 24 prior extra-orbital), and half were Afro-Caribbean. The average age at presentation was 45.3 years (range 18-78 years), with the commonest symptoms being swelling, pain and diplopia; of clinical signs, most patients (87%) had eyelid swelling, reduced motility (25%), and disease-related visual impairment (10%). Localized dacryoadenitis was present in 49/61 (21/49 bilateral) patients, and more diffuse disease in 28/61 (8/28 bilateral). Systemic involvement was found in 23 (62%) of the 37 first presenting with orbital disease. Twenty-three (38%) patients were observed and two-thirds received oral corticosteroids, with 53/61 (87%) patients having subjective and objective clinical improvement. The average follow-up was 53.4 months (range 1-315 months) and clinical recurrence occurred in 12 (20%) patients at 26.5 months (range 1-115 months) after first diagnosis. Systemic sarcoidosis may be discovered in about two-thirds of patients presenting with SLGO (that tends to present with inflammatory features), but the treatment response appears similar in patients with known sarcoidosis and those with newly-diagnosed systemic disease after orbital presentation. With long-term follow-up, a third of patients have spontaneous regression of orbital disease, but 20% have recurrence after reducing or stopping systemic immunosuppression.

Long-term results of the treatment of primary hyperhidrosis with oxybutynin: follow-up of 1,658 cases.

Hyperhidrosis (HH) is characterized by exaggerated sweating in a specific region due to hyperfunction of the sweat glands. In the late 2000s, we started treating patients with an anticholinergic, oxybutynin, that was not being used until then. To present, after 12years of utilizing this medication in our service, the substantial experience obtained with the use of oxybutynin as an initial treatment of HH in a large series of 1,658 patients. We analyzed 1,658 patients treated with oxybutynin for HH from May 2006 to June 2018. The patients were divided into four groups according to the main site of HH: the plantar group, the axillary group, the facial group, and the palmar group. To measure the degree of satisfaction, a quality of life (QoL) questionnaire was used. Pre-treatment QoL was poor or very poor in more than 94% of the cases, and the palmar group had the worst quality of life. After treatment, we observed an improvement in the quality of life in 77% of patients. More than 70% of the patients in all groups present moderate or optimal subjective clinical improvement in sweating after treatment. The group with the best result was the facial group. Intense dry mouth was reported in24.9% of all patientsin all groups. This study included a large number of patients followed for a long period and demonstrated the good effectiveness of treatment with oxybutynin for hyperhidrosis in the main sites of sweating.

Lymphaticovenous Anastomosis for Lower Extremity Lymphedema: A Systematic Review.

Background Lymphedema is an accumulation of protein-rich fluid in the interstitial spaces resulting from impairment in the lymphatic circulation that can impair quality of life and cause considerable morbidity. Lower extremity lymphedema (LEL) has an overall incidence rate of 20%. Conservative therapies are the first step in treatment of LEL; however, they do not provide a cure because they fail to address the underlying physiologic dysfunction of the lymphatic system. Among several surgical alternatives, lymphaticovenous anastomosis (LVA) has gained popularity due to its improved outcomes and less invasive approach. This study aims to review the published literature on LVA for LEL treatment and to analyze the surgical outcomes. Methods PubMed database was used to perform a comprehensive literature review of all articles describing LVA for treatment of LEL from Novemeber 1985 to June 2019. Search terms included “lymphovenous” OR “lymphaticovenous” AND “bypass” OR “anastomosis” OR “shunt” AND “lower extremity lymphedema.” Results A total of 95 articles were identified in the initial query, out of which 58 individual articles were deemed eligible. The studies included in this review describe notable variations in surgical techniques, number of anastomoses, and supplementary interventions. All, except one study, reported positive outcomes based on limb circumference and volume changes or subjective clinical improvement. The largest reduction rate in limb circumference and volume was 63.8%. Conclusion LVA demonstrated a considerable reduction in limb volume and improvement in subjective findings of lymphedema in the majority of patients. The maintained effectiveness of this treatment modality in long-term follow-up suggests great efficacy of LVA in LEL treatment.

301P - Oncological outcome following 3 Drug NACT for Bucco-Alveolar carcinoma with Supra-notch ITF extension

BackgroundBucco-alveolar carcinoma is a clinical entity prevalent in Asia. These cancers have early involvement of Infra-temporal fossa (ITF) and subsequent poor oncological outcomes. Locally advanced Bucco-alveolar complex carcinoma (T4b) with supra-notch (supra-sigmoid) ITF extension is oncological challenge with poor outcome. We analysed oncological outcome in patients managed with 3-drug Neo-adjuvant chemotherapy (NACT) followed with surgical compartmental resection and adjuvant chemoradiation. Methods33 cases of T4b Bucco-alveolar complex carcinoma with supra-notch ITF extension included from June 2009 to January 2017. Patients received 3-Drug NACT (3-day regimen: IV Cisplatin 75 mg/m2 or IV Carboplatin 70 mg/m2 + IV Docetaxel 75 mg/m2 + IV 5-FU 1000 mg/m2) for 2-3 cycles every 21 days. Response assessed with clinical examination, improvement in symptoms (improved mouth opening etc.) and Response Evaluation Criteria In Solid Tumors (RECIST) criterion. Patients showing good response on NACT underwent Compartmental surgical resection with complete ITF clearance followed by adjuvant chemoradiotherapy (5-6 cycles weekly Inj. Cisplatin with 60Gy/30# RT). Data analyzed using STATA 13 and Kaplan Meir graphs for survival rates. Results31 patients (93.9%) showed response on NACT and underwent Surgery, with 2 patients showing disease progression after 1st cycle of NACT were treated non-surgically with palliative intent. Clinical response according to RECIST criterion & subjective clinical improvement > 50% was noted in 18 cases while < 50% in 13 cases. 22 of 31 patients were disease free with 7 loco-regional recurrences. There were no recurrences in ITF. Overall survival and disease-free survival rate was 81.8% and 70.9% respectively at mean follow-up of 30 months. Conclusions3-drug NACT followed by surgical resection in cases showing response to NACT with adjuvant chemoradiation provides a realm of hope for these borderline resectable T4b supra-notch cases. NACT provides an opportunity to attain better microscopically negative resection margins and helps in proper bio-selection of cancers according to their radio-chemosensitivity and response leading to better oncological outcomes. Legal entity responsible for the studyThe authors. FundingHas not received any funding. DisclosureAll authors have declared no conflicts of interest.

INTESTINAL FAILURE IN SYSTEMIC SCLEROSIS: A STRATEGY ATTEMPT FOR INTESTINAL REHABILITATION

Objective Aim of our group was to define etiopathogenesis of severe malnutrition in an highly compromised severely underweight patient, and to define the most high-benefit/low-risk nutritional intervention. Research Methods & Procedures A 62-years-old women affected by systemic sclerosis (SS) was admitted because of asthenia, dyspnea and weight loss: -38% of her usual body weight (BW) in 6 years, -23% BW in the last 6 months; current BW was 31kg (Body Mass Index 12.1kg/m2). Nutritional assessment at admission excluded the hypothesis of both anorexia nervosa and dysphagia. After prompt thiamin and multivitaminic/multimineral supplementation, we started night-time enteral nutrition support (EN) through naso-gastric tube (SNG) with semi-elemental mixture. Neither BW nor prealbumin improved despite rich oral intakes, as documented by the dietitian's monitoring, plus EN support. Risks from parenteral nutrition (PN), mainly infective ones, were too high with respect to the patient. We then decided to stop oral nutrition and to give the patient total enteral nutrition (TEN) with semi-elemental mixture in slow, continuous administration. Results Fourteen days after the beginning of TEN, prealbumin increased from 10 to 21 mg/dL. Refeeding Syndrome was adequately prevented. The patient well tolerated slow, continuous TEN and felt subjective clinical improvement. Conclusions SS can provoke motility disorders associated with inflammation, leading to intestinal failure and, consequently, to severe malnutrition. Nutritional assessment and follow-up after SS diagnosis could positively influence this evolution. Anyway, when intestinal failure is already present, an attempt to intestinal rehabilitation is demanded, especially when risks from PN are too high for the patient.

Unicompartmental Knee Replacement Combined to Anterior Cruciate Ligament Reconstruction: Midterm Results.

A study was conducted to retrospectively evaluate the outcomes of combined medial unicompartmental knee replacement (UKR) and anterior cruciate ligament (ACL) reconstruction. The hypothesis was that this procedure would lead to satisfying results in patients affected by medial osteoarthritis and ACL insufficiency. Fourteen patients with ACL deficiency and concomitant medial compartment symptomatic osteoarthritis were treated from 2006 to 2010. Twelve of them were followed-up for an average time of 7.8 year (range: 6-10 years). Assessment included Knee Osteoarthritis Outcome score (KOOS), Oxford Knee score (OKS), American Knee Society scores (AKSS), Western Ontario and McMaster (WOMAC) index of osteoarthritis, Tegner's activity level, objective examination including instrumented laxity test with KT-1000 arthrometer, and standard X-rays. KOOS score, OKS, WOMAC index, and the AKSS improved significantly at follow-up (p < 0.001). There was no clinical evidence of instability in any of the knees as evaluated with clinical and instrumented laxity testing (p < 0.001). No pathologic radiolucent lines were observed around the components. In one patient, a total knee prosthesis was implanted due to the progression of signs of osteoarthritis in the lateral compartment 3 years after primary surgery. UKR combined with ACL reconstruction is an effective therapeutic option for the treatment of combined medial unicompartmental knee osteoarthritis and ACL deficiency and confirms subjective and objective clinical improvement up to 8 years after surgery. This study reflects level IV evidence.

Arthroscopic-assisted latissimus dorsi transfer for massive rotator cuff tear: a systematic review.

This systematic review provides a comprehensive description of different surgical techniques for massive rotator cuff tears (MRCTs) using arthroscopic-assisted latissimus dorsi transfer (A-LDT), reporting clinical outcomes and complications. We searched the literature on Medline (PubMed), Web of Science and Scopus databases using the combined keywords 'latissimus dorsi', 'tendon', 'transfer', 'rotator cuff tears', 'shoulder' and 'arthroscopy' to identify articles published in English, Spanish, French and Italian. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement was followed for the manuscript selection. Ten studies (five retrospective and five prospective investigations), all published between 2014 and 2018, fulfilled our inclusion criteria, dealing with 348 (55.7% male) patients, with a mean age of 61.6 years (range 31-83). A-LDT is a technical demanding procedure. When compared with the open technique, it does not seem to provide significant subjective and objective clinical outcome improvements. A-LDT seems to yield lesser surgical complications and post-operative stiffness. Sparing the deltoid muscle belly could result in a more effective shoulder post-surgery function. Further comparative randomized controlled trials with longer follow-up are needed to clarify the potentially promising superiority of A-LDT.

Applying the Molecular Adsorbent Recirculating System (MARS) in the Treatment of Acute Liver Failure (ALF) Case Report

Abstract Acute liver failure (ALF) is a rare but life-threatening illness with multiple organ failure. The short-term mortality rate exceeded 80 % despite modern approaches in treatment. Drugs, infections by hepatic viruses and toxins are the most common causes of ALF. Progressive jaundice, coagulation disorder and hepatic encephalopathy are dominated as a clinical signs of the illness. We present a case of a 36-year-old Caucasian woman hospitalized in ICU due to yellow discoloration of the skin and sclera, severe disseminated coagulopathy and hemodynamic instability. ALF is developed due to Hepatitis B Virus infection, resulting in hepatic toxicity as well as coma. General condition rapidly improved after applying of Molecular Adsorbent Recirculating System (MARS), an extracorporeal liver support system based on albumin dialysis. It is relatively expensive treatment that is used for the patient with hepatic encephalopathy grade 3 or 4 in our institution. In conclusion, an early administration of MARS significantly reveals subjective and objective clinical improvement in the case we presented.

F216. SLEEP QUALITY AND CLINICAL IMPROVEMENT IN FIRST EPISODE PSYCHOSIS

BackgroundSleep disturbance is a common feature in early psychosis. Sleep quality has shown to be associated with both symptom severity and clinical improvement in persons with chronic illness.Understanding the influence of sleep quality in early psychosis can be beneficial in determining interventions for coordinated specialty care (CSC). Using patients from a CSC intervention program for first episode psychosis, we investigated the association between subjective sleep quality with clinical response and clinical symptom correlates.MethodsParticipants were consecutive patients admitted between March 2015 to June 2017 who underwent coordinated specialty care at Penn PERC (Psychosis Evaluation and Recovery Center). Eligible participants were young persons ages 16–35 years who had experienced onset of psychosis within 3 years prior to intake and who underwent 2-years of CSC for early psychosis, including cognitive therapy for psychosis recovery (CT-R), medication management, family education and occupational support. Standardized self and observer based rating scales evaluating sleep quality (PSQI) and other clinical symptoms, e.g., anxiety (BAI), depression (BDI) and affective states (PANAS), and clinical improvement (CGI-I) were administered at intake, after 3 months, 6 months and subsequently every 6 months of CSC. Participants provided informed consent. 48 participants completed assessment at 2-time points between intake and 2–4 months later and 38 underwent assessment at 3 time points, including 6–7 months following intake. Correlational analyses were performed on PSQI change (slope) over 3 assessments and change in BAI, BDI, PANAS-negative, PANAS-positive. Analysis were further stratified by improvement – CGI-I <2 (much improvement) (n=17) and CGI >3 (little/no improvement) (n=21).ResultsOf 48 patients, average age at intake was 22 years (Male:Female=40:8; Caucasian:African-American/Other=28:20). Primary analyses of sleep quality and clinical improvement included participants with three PSQI rating timepoints over 6–7 months of CSC (n=38). Overall PSQI ratings did not change significantly over time. BAI and BDI-II scores significantly decreased over time, indicating subjective clinical improvement with treatment. There was a trend for positive correlations among PSQI, and BAI and BDI-II scores. When stratified by improvement, those rated ‘much improved’ group greater reduction of PSQI scores.DiscussionWe found that improved sleep quality was present in participants who experienced much global clinical improvement over 6 months of CSC. In addition, better sleep quality correlated with reduced depression and anxiety symptoms. Though these findings do not address direction of causality, our findings indicate that improving sleep quality should be a specific focus in treatment of early psychosis. Further analysis will be conducted to investigate the relationship between sleep and clinical improvement using other clinical measures, such as symptom severity, and the dataset will be expanded to include data through the end of 2017.

Lymphographic-Like Technique for the Treatment of Microcystic Lymphatic Malformation Components of

The treatment of microcystic lymphatic malformations remains challenging. Our aim was to describe the lymphographic-like technique, a new technique of slow bleomycin infusion for the treatment of microcyst components of <3 mm, performed at our institution. A retrospective analysis of a prospectively collected lymphatic malformation data base was performed. Patients with at least 1 microcystic lymphatic malformation component demonstrated on MR imaging treated by lymphographic-like technique bleomycin infusion were included in the study. Patient interviews and MR imaging were performed to assess subjective and objective (microcystic lymphatic malformation size decrease of >30%) clinical improvement, respectively. Patients were reviewed 3 months after each sclerotherapy session. Lymphographic-like technique safety and efficacy were assessed. Between January 2012 and July 2016, sixteen patients (5 males, 11 females; mean age, 15 years; range, 1-47 years) underwent the bleomycin lymphographic-like technique for microcystic lymphatic malformations. Sixty sclerotherapy sessions were performed, with a mean of 4 sessions per patient (range, 1-8 sessions) and a mean follow-up of 26 months (range, 5-58 months). We observed no major and 3 minor complications: 1 eyelid infection, 1 case of severe postprocedural nausea and vomiting, and 1 case of skin discoloration. One patient was lost to follow-up. Overall MR imaging objective improvement was observed in 5/16 (31%) patients; overall improvement of clinical symptoms was obtained in 93% of treated patients. The bleomycin lymphographic-like technique for microcystic lymphatic malformations is safe and feasible with objective improvement in about one-third of patients. MR signal intensity changes after the lymphographic-like technique are associated with subjective improvement of the patient's symptoms.

Contemporary outcomes of elective iliocaval and infrainguinal venous intervention for post-thrombotic chronic venous occlusive disease

Patients with iliofemoral deep venous thrombosis are at risk for development of post-thrombotic syndrome. Iliac vein stenting has been shown to significantly improve clinical outcomes in patients with venous outflow obstruction, although many studies include a heterogeneous population with several different venous pathologic processes. Our objective was to evaluate the results of iliocaval and infrainguinal venous intervention for venous outflow obstruction due to post-thrombotic chronic venous occlusive disease. All patients treated at a single institution for symptomatic iliocaval venous occlusive lesions with and without infrainguinal extension between 2008 and 2015 were retrospectively analyzed. Nonthrombotic iliac vein lesions were excluded from analysis. All patients with symptomatic post-thrombotic occlusion of the iliac vein or inferior vena cava (IVC) and a Clinical, Etiology, Anatomy, and Pathophysiology (CEAP) score of 3 or greater were included. Demographics of the patients, presence of IVC filters at presentation, presenting CEAP score, postintervention CEAP score, primary and secondary patency, wound healing and subjective clinical improvement outcomes, and procedural details were recorded in a database. There were 105 patients with symptomatic iliocaval venous occlusive lesions identified, of which 31 patients (42limbs) met inclusion criteria. Presenting symptoms included pain or swelling (100%); venous claudication (81%); and CEAP class 3 (76%), 4 or 5 (14%), or 6 (10%). All patients presented with either subacute (>30days [35%]) or chronic (>90days [65%]) iliocaval venous thrombosis. Procedural technical success with venous recanalization was achieved in 100% of cases and in 46% of IVC filter retrieval attempts. Overall clinical improvement was achieved in 84% of patients; complete clinical resolution was obtained in 42% and a decrease in CEAP score in 65%. At a mean follow-up of 14.7months (range, 2-49months), primary and secondary 1-year patency was 66% and 75% overall, and primary patency was equivalent between patients requiring isolated iliac venous stenting and those requiring infrainguinal stent extension (68% vs 65%, respectively; P= .74, not significant). Patients who presented with IVC filters had a higher rate of complete clinical resolution if the filter could be removed (100%) compared with those patients in whom the filter could not be removed (17%; P< .01). Treatment of chronic venous occlusive disease with iliocaval and infrainguinal venous stenting is associated with acceptable1-year patency rates, healing of venous ulcers, and a significant reduction in symptoms and CEAP score. Patients who underwent successful removal of indwelling IVC filters showed improved clinical outcomes compared with those in whom the IVC filter could not be removed.

Adipose-derived stem cells in orthopaedic pathologies.

To examine the current literature regarding the clinical application of adipose-derived stem cells (ADSCs) for the management of orthopaedic pathologies. MEDLINE,SCOPUS, CINAHL and EMBASE (1950 to April 14, 2017) were searched by two independent investigators for articles published in English. Reviews, meta-analyses, expert opinions, case reports, mini case series and editorials were excluded. Furthermore, we excluded animal studies, cadaveric studies and in vitro studies. ADSCs seem to produce excellent clinical results. However, the length and modalities of follow-up in the different conditions are extremely variable. Nevertheless, it appears that the use of adipose-derived stem cells is associated with subjective and objective clinical improvements and minimal complication rates. None of the studies identified is a randomized double-blinded trial, and most of the selected studies present major limitations, and different methods, confounding the results of our review. It is necessary to conduct more and better studies to ascertain whether ADSCs really play a role in orthopaedic surgery with particular attention to ADSCs harvesting method, type of administration and the conditions treated. The current literature regarding the use of ADSCs for orthopaedic pathologies is limited. At present, long-term safety is the biggest challenge of ADSCs based regenerative medicine. Level IV-Study of Level I, II, III, IV.

Combined interventional sialendoscopy and intraductal steroid therapy for recurrent sialadenitis in Sjögren's syndrome: Results of a pilot monocentric trial.

To evaluate the effectiveness of interventional sialendoscopy alone or combined with outpatient intraductal steroid irrigations in patients with sialadenitis due to Sjögren's syndrome (SS). A pilot therapeutic study. ENT Clinics, Universities of Milan and Pavia. We included 22 patients with SS of whom 12 underwent interventional sialendoscopy followed by intraductal steroid irrigations (group A), and 10 interventional sialendoscopy alone (group B). The following outcome measures were considered and recorded before and after the therapeutic intervention: (i) number of episodes of glandular swelling, (ii) cumulative prevalence of patients with glandular swelling assessed by the specific domain, the EULAR SS Disease Activity Index (ESSDAI), (iii) severity of pain by means of a 0-10 pain visual analogue scale (VAS), (iv) severity of xerostomia and other disease symptoms assessed by the EULAR SS Patient Reported Index (ESSPRI) and the Xerostomia Inventory questionnaire. The postoperative reduction in the mean number of episodes of glandular swelling was 87% (95% CI: 77-93) and 75% (95% CI: 47%-88%) in the groups A and B, respectively. The percentage of patients with glandular swelling decreased from 41.7% to 0.0% in the group A and from 30.0% to 0.0% in the group B, respectively. Most of the patients experienced a subjective clinical improvement documented by the statistically significant reductions in the postoperative mean pain VAS (group A P<.001; group B P=.004), Xerostomia Inventory (P<.001 and P=.003) and ESSPRI scores (P<.001 and P=.008). Interventional sialendoscopy followed by outpatient intraductal steroid irrigations was more effective than interventional sialendoscopy alone, when pain VAS, Xerostomia Inventory and ESSPRI scores before and after treatment were analysed together using the multivariate Hotelling T2 test (P=.0173). This pilot study confirms that interventional sialendoscopy with steroid duct irrigation significantly reduces the number of painful episodes of sialadenitis and improves the subjective sensation of oral dryness and other disease symptoms in patients with SS. The study results also suggest that the improvement is greater when interventional sialendoscopy is combined with a cycle of outpatient steroid ductal irrigations. Larger controlled randomised studies are certainly needed to confirm these preliminary data.

Revision Anterior Cruciate Ligament Reconstruction with Contralateral Hamstring Tendon Grafts: 6 Years Follow-Up.

Purpose The purpose of this study was to retrospectively evaluate the clinical outcome of revision anterior cruciate ligament (ACL) reconstruction with contralateral hamstring tendon autografts, specifically with regard to patient satisfaction, return to preinjury activity level, and postoperative functional outcomes. Methods Between 2004 and 2011, 23 patients underwent revision ACL reconstruction with contralateral autogenous hamstring tendon grafts and were retrospectively reviewed at an average follow-up of 6.3 years. Subjective and functional evaluations were performed. The Tegner score, Knee Injury and Osteoarthritis Outcome Score (KOOS), and International Knee Documentation Committee (IKDC) Subjective Knee Form were used. Objective evaluation included range of motion, Lachman test, pivot-shift test, and KT-1000 instrumented laxity testing. Wilcoxon test was used to compare the preoperative and follow-up status. Differences with a p -value of <0.05 were considered statistically significant. Results No major complications were reported. The mean KOOS significantly increased from a preoperative mean of 62.8 ± 8.3 to 85.8 ± 6.9 ( p < 0.001). IKDC subjective score significantly improved from 29.2 ± 10.4 to 72.8 ± 5.2 ( p < 0.001). The median Tegner activity score significantly improved from a preoperative mean of 6.5 (range: 4–10) to 7.5 (range: 7–10) ( p < 0.001). Most of the patients increased or returned to the same activity level, with 61% of the patients returning to cutting and pivoting sports. Conclusion The use of contralateral hamstring tendon autografts for ACL revision surgery represents a valid option following a failed primary ACL reconstruction and confirms subjective and objective clinical improvement 6 years after surgery. Level of Evidence Level IV, therapeutic case series.

Long-term treatment of chronic migraine with onabotulinumtoxinA: Efficacy, quality of life, and tolerability in a real-life setting

Botulinum toxin was shown to be effective in treatment of chronic migraine. We wanted to explore its efficacy and tolerability in chronic application under real-life conditions. For this, 27 consecutive patients (age 45.6 ± 10.8 years, 25 females, 2 males) received altogether 176 injection series (IS) with 189.7 ± 45.8MU onabotulinumtoxinA (Botox(®)) according to the PREEMPT scheme. During the study period altogether 6.5 ± 2.9 (min 4, max 13) IS were applied per patient (total treatment time of 73.1 ± 36.9 weeks). 96 % of the patients reported benefit. Monthly headache days were reduced from 18.9 ± 3.9 to 8.7 ± 4.5 (p < 0.001, -53.7 %), migraine days from 16.8 ± 4.9 to 7.4 ± 4.6 (p < 0.001, -55.1 %), autonomic days from 8.6 ± 7.5 to 2.7 ± 4.2 (p < 0.001, -71.9 %) and medication days from 14.2 ± 4.6 to 8.3 ± 4.2 (p < 0.001, -71.1 %). Health-related quality of life improved by 0.6-1.5 standard deviations (SD) (Short Form Health Survey), migraine-related quality of life by 1.4-2.0 SD (Migraine-Specific Quality of Life Questionnaire) and by 1.9 SD (Headache Impact Test), depression by 1.1 SD (Beck Depression Inventory). Subjective global clinical improvement was 2.6 ± 0.6 (Global Clinical Improvement Scale). All improvements were stable throughout the entire study period. Adverse effects were infrequent, mild and transient. Botulinum toxin provides highly effective and safe long-term treatment of chronic migraine.

Endoscopic third ventriculostomy for treatment of adult hydrocephalus: long-term follow-up of 163 patients.

OBJECTIVE The efficacy of endoscopic third ventriculostomy (ETV) for the treatment of pediatric hydrocephalus has been extensively reported in the literature. However, ETV-related long-term outcome data are lacking for the adult hydrocephalus population. The objective of the present study was to assess the role of ETV as a primary or secondary treatment for hydrocephalus in adults. METHODS The authors performed a retrospective chart review of all adult patients (age ≥ 18 years) with symptomatic hydrocephalus treated with ETV in Calgary, Canada, over a span of 20 years (1994-2014). Patients were dichotomized into a primary or secondary ETV cohort based on whether ETV was the initial treatment modality for the hydrocephalus or if other CSF diversion procedures had been previously attempted respectively. Primary outcomes were subjective patient-reported clinical improvement within 12 weeks of surgery and the need for any CSF diversion procedures after the initial ETV during the span of the study. Categorical and actuarial data analysis was done to compare the outcomes of the primary versus secondary ETV cohorts. RESULTS A total of 163 adult patients with symptomatic hydrocephalus treated with ETV were identified and followed over an average of 98.6 months (range 0.1-230.4 months). All patients presented with signs of intracranial hypertension or other neurological symptoms. The primary ETV group consisted of 112 patients, and the secondary ETV consisted of 51 patients who presented with failed ventriculoperitoneal (VP) shunts. After the initial ETV procedure, clinical improvement was reported more frequently by patients in the primary cohort (87%) relative to those in the secondary ETV cohort (65%, p = 0.001). Additionally, patients in the primary ETV group required fewer reoperations (p < 0.001), with cumulative ETV survival time favoring this primary ETV cohort over the course of the follow-up period (p < 0.001). Fifteen patients required repeat ETV, with all but one experiencing successful relief of symptoms. Patients in the secondary ETV cohort also had a higher incidence of complications, with one occurring in 8 patients (16%) compared with 2 in the primary ETV group (2%; p = 0.010), although most complications were minor. CONCLUSIONS ETV is an effective long-term treatment for selected adult patients with hydrocephalus. The overall ETV success rate when it was the primary treatment modality for adult hydrocephalus was approximately 87%, and 99% of patients experience symptomatic improvement after 2 ETVs. Patients in whom VP shunt surgery fails prior to an ETV have a 22% relative risk of ETV failure and an almost eightfold complication rate, although mostly minor, when compared with patients who undergo a primary ETV. Most ETV failures occur within the first 7 months of surgery in patients treated with primary ETV, but the time to failure is more prolonged in patients who present with failed previous shunts.

Long-term treatment of chronic migraine with OnabotulinumtoxinA: efficacy, quality of life and tolerability in a real-life setting.

Botulinum toxin was shown to be effective in treatment of chronic migraine. We wanted to explore its efficacy and tolerability in chronic application under real-life conditions. For this, 27 consecutive patients (age 45.6±10.8years, 25 females, 2 males) received altogether 176 injection series (IS) with 189.7±45.8MU onabotulinumtoxinA (Botox(®)) according to the PREEMPT scheme. During the study period altogether 6.5±2.9 (min 4, max 13) IS were applied per patient (total treatment time of 73.1±36.9weeks). 96% of the patients reported benefit. Monthly headache days were reduced from 18.9±3.9 to 8.7±4.5 (p<0.001, -53.7%), migraine days from 16.8±4.9 to 7.4±4.6 (p<0.001, -55.1%), autonomic days from 8.6±7.5 to 2.7±4.2 (p<0.001, -71.9%) and medication days from 14.2±4.6 to 8.3±4.2 (p<0.001, -71.1%). Health-related quality of life improved by 0.6-1.5 standard deviations (SD) (Short Form Health Survey), migraine-related quality of life by 1.4-2.0 SD (Migraine-Specific Quality of Life Questionnaire) and by 1.9 SD (Headache Impact Test), depression by 1.1 SD (Beck Depression Inventory). Subjective global clinical improvement was 2.6±0.6 (Global Clinical Improvement Scale). All improvements were stable throughout the entire study period. Adverse effects were infrequent, mild and transient. Botulinum toxin provides highly effective and safe long-term treatment of chronic migraine.

Pediatric brain tumors: An analysis of 5 years of data from a tertiary cancer care center, India.

Pediatric brain tumors are the most common solid tumors in children and a leading cause of mortality and morbidity in children worldwide. Even though there are enough data about the epidemiology of pediatric brain tumors in western population, there are only a few reports from developing countries like India. To study the epidemiological patterns of brain tumors in children, to study the patterns of care, and to assess the treatment response. A retrospective epidemiological approach is used. The records of children <18 years registered in our department from August 2006 to July 2011 diagnosed as primary brain tumors are selected. Data regarding age, sex, site of the tumor, clinical features, histology, treatment plan, and treatment response are collected. The World Health Organization classification of neoplasms was adopted. Of 250 cases, females (57%) slightly outnumbered males. The present study revealed that astrocytoma (52%) is the most common brain tumor in childhood. Surgery was the main modality of treatment. Chemotherapy was given to 16% of patients. Even though radiation therapy was offered to 74% of patients, only 42% completed radiotherapy. There was subjective clinical improvement in 68% of patient population after treatment. This is the second study from Tamil Nadu that deals with epidemiology of brain tumors. Multimodality management including surgery, chemotherapy, and radiation therapy remains the cornerstone in the management of pediatric brain tumors.