Long-Term Safety and Efficacy of Minimally Invasive Lumbar Decompression Procedure for the Treatment of Lumbar Spinal Stenosis With Neurogenic Claudication: 2-Year Results of MiDAS ENCORE

Background and Objectives This study evaluated the long-term durability of the minimally invasive lumbar decompression (MILD) procedure in terms of functional improvement and pain reduction for patients with lumbar spinal stenosis and neurogenic claudication due to hypertrophic ligamentum flavum. This is a report of 2-year follow-up for MILD study patients. Methods This prospective, multicenter, randomized controlled clinical study compared outcomes for 143 patients treated with MILD versus 131 treated with epidural steroid injections. Follow-up occurred at 6 months and at 1 year for the randomized phase and at 2 years for MILD subjects only. Oswestry Disability Index, Numeric Pain Rating Scale, and Zurich Claudication Questionnaire were used to evaluate function and pain. Safety was evaluated by assessing incidence of device-/procedure-related adverse events. Results All outcome measures demonstrated clinically meaningful and statistically significant improvement from baseline through 6-month, 1-year, and 2-year follow-ups. At 2 years, Oswestry Disability Index improved by 22.7 points, Numeric Pain Rating Scale improved by 3.6 points, and Zurich Claudication Questionnaire symptom severity and physical function domains improved by 1.0 and 0.8 points, respectively. There were no serious device-/procedure-related adverse events, and 1.3% experienced a device-/procedure-related adverse event. Conclusions MILD showed excellent long-term durability, and there was no evidence of spinal instability through 2-year follow-up. Reoperation and spinal fracture rates are lower, and safety is higher for MILD versus other lumbar spine interventions, including interspinous spacers, surgical decompression, and spinal fusion. Given the minimally invasive nature of this procedure, its robust success rate, and durability of outcomes, MILD is an excellent choice for first-line therapy for select patients with central spinal stenosis suffering from neurogenic claudication symptoms with hypertrophic ligamentum flavum. Clinical Trial Registration This study was registered at ClinicalTrials.gov, identifier NCT02093520. This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. Accepted for publication June 8, 2018. Address correspondence to: Peter S. Staats, MD, MBA, National Spine and Pain Centers, 170 Avenue at the Common, Ste 6, Shrewsbury, NJ 07702 (e-mail: peterstaats@hotmail.com). P.S.S. and R.M.B. are study principal investigators for MiDAS ENCORE. In this role, they have been responsible for study oversight. Responsibilities include protocol review, assistance with site selection, site investigator support, oversight of patient enrollment and protocol compliance, and adjudication of adverse events. This trial was sponsored by Vertos Medical. The sponsorship includes study-related supplies and expenses, as well as funding for statistical analysis services by an independent provider. The authors declare no conflict of interest. Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (www.rapm.org). Copyright © 2018 by American Society of Regional Anesthesia and Pain Medicine.

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Best perioperative practice in management of ambulatory patients with obstructive sleep apnea

Purpose of review The perioperative outcome in obstructive sleep apnea (OSA) patients undergoing ambulatory surgery can be potentially impacted by the type of anesthetic technique, fluid management and choice of anesthetic agents. This review highlights the best perioperative practices in the management of OSA patients undergoing ambulatory surgical procedures. Recent findings A recent meta-analysis found that STOP-Bang might be used as a perioperative risk stratification tool. Patients with high-risk OSA (STOP-Bang ≥3) were found to be associated with an increased risk of postoperative complications and prolonged length of hospital stay compared with low-risk OSA (STOP-Bang 0-2) patients undergoing noncardiac surgical procedures. A bidirectional relationship exists between OSA and difficult airway. Both suspected or diagnosed OSA may be associated with either difficult intubation or difficult mask ventilation or both. A recent meta-analysis identified OSA as an important risk factor for opioid-induced respiratory depression. A dose–response relationship was shown between the morphine equivalent daily dose and death or near-death events in OSA patients undergoing surgery. Postoperative continuous monitoring is recommended for high-risk OSA patients receiving opioids. Minimising the dose of muscle relaxant, neuromuscular monitoring and ensuring complete reversal of neuromuscular blockade before extubation is essential in OSA patients to avoid postoperative complications. Whenever feasible, regional anesthesia with multimodal analgesia may be considered as a better alternative to general anesthesia in OSA patients. Summary Patients with OSA and associated comorbidities present a challenge to anesthesiologists as they are at a high risk of perioperative complications. It is important to identify patients with OSA, with the goal to raise awareness among providers, mitigate risk and improve outcomes. Correspondence to Frances Chung, Professor, Department of Anesthesia, Toronto Western Hospital, University Health Network, 399 Bathurst Street, MCL 2-405, Toronto, ON M5T 2S8, Canada. E-mail: Frances.chung@uhn.ca Copyright © 2018 YEAR Wolters Kluwer Health, Inc. All rights reserved.

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Pediatric Otolaryngological Emergency: An Experience from a Tertiary Care Teaching Institution at Kolkata, India

Abstract

Otolaryngological conditions constitute a major share of emergency medical problem among children. The present study was conducted to assess the patient profiles, incidences morbidities, mode of presentation and managements of different otolaryngological emergencies among pediatric patients presented in a tertiary care hospital. Descriptive cross-sectional study by analysing retrospectively collected information pertaining to the patients attended ENT emergency service department of a tertiary care hospital, Kolkata. Data were collected using predesigned proforma and were analysed with the help of SPSS version 20. About 39.0% of total ENT emergency attendance was contributed by pediatric age group. The male female ratio was 1:1.33 with average age of 58.95 ± 34.42 (mean ± SD) months. Half of the attendees had ear problem and almost one-third reported complaints related to nose. The major complaints at the time of presentation were earache (32.3%), nasal foreign body (24.0%) and aural foreign body (13.3%) closely followed by aero-digestive tract foreign body (12.0%). Inflammatory conditions affected the ears more, foreign bodies found most commonly in nose and miscellaneous condition such as impacted wax was found to be related to ear in significantly higher proportion. Conservative management was provided to 96.25% of patients. Foreign body insertion was found to be associated with lower age group. Most of the emergencies were managed conservatively which might be done at subdivision or district level to reduce the undesirable burden on the tertiary care medical colleges.

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Ossifying Fibroma of Maxilla in a Female Affected by Neurofibromatosis Type 1

Abstract

Ossifying fibroma is a benign fibro-osseous lesion found exclusively in jaws. It has a predilection for premolar–molar region in the mandible. The occurrence of OF as solitary lesions with no underlying disease is common in jaws. However its co-existence in patients with neurofibromatosis type 1 (NF1) has not been described in jaws. NF1, also known as von Recklinghausen's disease or peripheral neurofibromatosis, is an autosomal dominant multisystem disorder that approximately affects 1 in 2500–3000 births. The common manifestations of this disease include Café-au-lait macules, skinfold freckling, cutaneous neurofibromas, blue-red and pseudoatrophic macules on skin, plexiform neurofibroma, scoliosis, optic glioma. So far only one case of ossifying fibroma (OF) in such patients has been reported in the skull but not in the maxillofacial region. We report a case of OF of the maxilla in a 45 year old female suffering from NF1. To the best of our knowledge this is the first case report where OF occurred in the maxilla in patient with NF1.

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Ahila’s Diathermy Round Knife for Endoscopic Ear Surgery

Abstract

As endoscopic ear surgery is evolving day by day there is a constant need for improvisation in terms of instrumentation, visualization and clear bloodless surgical field. The applications of Ahila's Diathermy Round Knife for Endoscopic Ear Surgery are presented. The development of Ahila's diathermy round knife will prevent shifting to two handed ear surgery or the need for Endo holders. This new instrument is a game changer in endoscopic ear surgery creating a clean incision and bloodless field to operate. Surgical Instruments represent a major financial asset to the healthcare facility. Careful attention to care, handling and sterilization is essential to avoid costly replacements, enhance patient and surgeon satisfaction, reduce costs and delays in the Operating room and enhance patient safety. Ahila's round diathermy knife may facilitate the performance of surgery and advance the art of Endoscopic surgery to a higher level.

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Cystic Myoepithelioma of Parapharyngeal Space

Abstract

Myoepitheliomas are rare tumours of salivary glands arising from myoepithelial cells, which are normal constituent of the salivary acini and ducts and are found between the epithelial cells and the basement membrane. The most common site of origin of Myoepitheliomas are the salivary glands and rarely other sites in the head and neck have been described in literature. Myoepithelioma arising from parapharyngeal space provide both a diagnostic and therapeutic challenge. We present such a case and discuss its diagnostic and therapeutic aspects.

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Nasal challenges in allergen immunotherapy trials

Purpose of review The nasal allergen challenge (NAC) model can be a valuable diagnostic tool for allergic rhinitis. Alongside its clinical use, NACs can be used as primary and secondary endpoints in studies evaluating allergen immunotherapy (AIT) products for allergic rhinitis treatment. This review will discuss the technical aspects of the NAC model and provide a summary of recent studies using NACs to assess existing and new AIT treatments. Recent findings Over the last 2 years, both titrated and single-dose nasal challenge protocols have been used to evaluate immunotherapies targeting grass, birch, house dust mite, and cat allergens. Early efficacy and dose-finding trials showed improvements in allergic symptoms and nasal tolerance to allergens after AIT treatment with standardized extracts or modified forms of whole allergen. NACs were also used in two proof-of-concept studies to illustrate the efficacy of intralymphatic immunotherapy with two concomitant allergens and subcutaneous immunotherapy with Fel d 1-specific IgG-blocking antibodies. Summary Along with existing therapies, nasal challenges are useful in evaluating AIT treatments in the very early stages of clinical development. However, because of the variety in challenge techniques and symptom assessments available, special attention must be placed in the protocol design in order to compare the study results with existing NAC publications. Correspondence to Anne K. Ellis, MD, MSc, FRCPC, Professor and Chair, Division of Allergy and Immunology, Allergy Research Unit, Kingston General Health Research Institute, Watkins 1D, 76 Stuart Street, Kingston, ON K7L 2V7, Canada. Tel: +1 613 548 2336; fax: +1 613 546 3079; e-mail: ellisa@queensu.ca Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.

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