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Freedom trial

Dario Amore, Roberto Scaramuzzi, Davide Di Natale, Carlo Curcio
The advantages of thymectomy as part of the treatment of myasthenia gravis has been demonstrated repeatedly in the literature. Both single-institution and multi-institution trials have shown robotic thymectomy to be safe, feasible and associated with better early clinical outcomes than the trans-sternal approach. Most reports have also documented the superiority of robotic technology in the dissection of the superior mediastinum over conventional thoracoscopy, thanks to instruments with more degrees of movement and freedom...
2018: Journal of Visualized Surgery
Chen Chen, Xinbin Zhou, Min Zhu, Shenjie Chen, Jie Chen, Hongwen Cai, Jin Dai, Xiaoming Xu, Wei Mao
PURPOSE: The superiority of catheter ablation (CA) for persistent (and long-standing persistent) atrial fibrillation (AF) is currently not well defined. We performed a meta-analysis of randomized controlled trials (RCTs) to assess the clinical outcomes of CA compared with medical therapy in persistent AF patients. METHODS: We systematically searched PubMed, EMBASE, the Cochrane Library, and for RCTs comparing CA with medical therapy in patients with persistent AF...
March 16, 2018: Journal of Interventional Cardiac Electrophysiology: An International Journal of Arrhythmias and Pacing
Vedavathi Kunnanayaka, Puneet Jain, Suvasini Sharma, Anju Seth, Satinder Aneja
Background: West syndrome is a catastrophic epilepsy syndrome characterized by infantile spasms, hypsarrhythmia, and developmental arrest or regression. Aim: The aim of this study was to explore the role of pyridoxine in the management of infantile spasms. Setting and Design: This was a pilot, randomized, open-label trial conducted at a tertiary level hospital from November 2012 to March 2014. Materials and Methods: Children aged 3 months to 3 years presenting with infantile spasms in clusters (at least 1 cluster/day) with hypsarrhythmia or its variants on electroencephalogram (EEG) were enrolled...
March 2018: Neurology India
Piero Perucca, Ingrid E Scheffer, Michelle Kiley
The International League Against Epilepsy has recently published a new classification of epileptic seizures and epilepsies to reflect the major scientific advances in our understanding of the epilepsies since the last formal classification 28 years ago. The classification emphasises the importance of aetiology, which allows the optimisation of management. Antiepileptic drugs (AEDs) are the main approach to epilepsy treatment and achieve seizure freedom in about two-thirds of patients. More than 15 second generation AEDs have been introduced since the 1990s, expanding opportunities to tailor treatment for each patient...
March 19, 2018: Medical Journal of Australia
Sandro Virgilio Porceddu, Mathias Bressel, Michael Geoffrey Poulsen, Adam Stoneley, Michael John Veness, Lizbeth Moira Kenny, Chris Wratten, June Corry, Stephen Cooper, Gerald Blaise Fogarty, Marnie Collins, Michael Kevin Collins, Andrew Martin John Macann, Christopher Gerard Milross, Michael Gordon Penniment, Howard Yu-Hao Liu, Madeleine Trudy King, Benedict James Panizza, Danny Rischin
Purpose To report the results of the Trans Tasman Radiation Oncology Group randomized phase III trial designed to determine whether the addition of concurrent chemotherapy to postoperative radiotherapy (CRT) improved locoregional control in patients with high-risk cutaneous squamous cell carcinoma of the head and neck. Patients and Methods The primary objective was to determine whether there was a difference in freedom from locoregional relapse (FFLRR) between 60 or 66 Gy (6 to 6.5 weeks) with or without weekly carboplatin (area under the curve 2) after resection of gross disease...
March 14, 2018: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
Carlo Pappone, Giuseppe Ciconte, Gabriele Vicedomini, Jan O Mangual, Wenwen Li, Manuel Conti, Luigi Giannelli, Felicia Lipartiti, Luke McSpadden, Kyungmoo Ryu, Marco Guazzi, Lorenzo Menicanti, Vincenzo Santinelli
BACKGROUND: Clinical outcomes after ablation of persistent atrial fibrillation remain suboptimal. Identification of AF drivers using a novel integrated mapping technique may be crucial to ameliorate the clinical outcome. METHODS AND RESULTS: Persistent AF patients were prospectively enrolled to undergo high-density electrophysiological mapping to identify repetitive-regular activities (RRas) before modified circumferential pulmonary vein (PV) ablation. They have been randomly assigned (1:1 ratio) to ablation of RRa followed by modified circumferential PV ablation (mapping group; n=41) or modified circumferential PV ablation alone (control group; n=40)...
March 2018: Circulation. Arrhythmia and Electrophysiology
David R Dobies, Kimberly R Barber
Evidence-based medicine (EBM) provides clinicians with beneficial information. Nonetheless, study findings are often arbitrary, speculative or provisional. The current state of misleading evidence exists in all applications, including those for guideline recommendations. We conductedan appraisal of the American College of Cardiologyand European Society of Cardiology Guidelines for revascularisation of complex coronary anatomy to determine the veracity of the evidence that recommendations were based on. Study-specific critical appraisals were conducted by the authors on the 5-year Synergy between percutaneous coronary intervention with Taxus and cardiac surgery (SYNTAX) and future revascularisation evaluation in patients with diabetes mellitus: optimal management of multivessel disease (FREEDOM) Trials...
2018: Open Heart
Federico M Asch, Mani A Vannan, Siddharth Singh, Bijoy Khandheria, Stephen H Little, Dominic J Allocco, Ian T Meredith, Ted E Feldman, Michael J Reardon, Neil J Weissman
BACKGROUND : Comparative echocardiographic data on transcatheter aortic valve replacement systems from randomized trials are limited. The REPRISE III trial (Repositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of Lotus Valve System - Randomized Clinical Evaluation) is a multicenter, randomized comparison of a mechanically expanded (Lotus) versus self-expanding (CoreValve) transcatheter aortic valve replacement device. This analysis rigorously assesses Doppler-derived valve hemodynamics and the impact on outcomes at 1 year in patients with extreme/high surgical risk treated with Lotus and CoreValve from REPRISE III...
March 12, 2018: Circulation
Manish K Jha, Shereen Wakhlu, Neha Dronamraju, Abu Minhajuddin, Tracy L Greer, Madhukar H Trivedi
BACKGROUND: Currently, there are no valid clinical or biological markers to personalize the treatment of depression. Recent evidence suggests that body mass index (BMI) may guide the selection of antidepressant medications with different mechanisms of action. METHODS: Combining Medications to Enhance Depression Outcomes (CO-MED) trial participants with BMI measurement (n = 662) were categorized as normal- or underweight (<25), overweight (25-<30), obese I (30-<35), and obese II+ (≥35)...
February 27, 2018: Journal of Affective Disorders
Yong Ding, Min Zhou, Yonggang Wang, Liang Cai, Zhenyu Shi
OBJECTIVE: This study aimed to perform a systematic review and meta-analysis of current evidence comparing the drug-eluting stent (DES) with the bare-metal stent (BMS) in the treatment of femoropopliteal artery disease (FPAD). METHOD: All relevant articles reporting the results of DES versus BMS implantation in FPAD were systematically searched in MEDLINE, EMBASE, and Cochrane database. Randomized controlled trial, cohort, and retrospective study were all included...
March 4, 2018: Annals of Vascular Surgery
Emily Stockings, Dino Zagic, Gabrielle Campbell, Megan Weier, Wayne D Hall, Suzanne Nielsen, Geoffrey K Herkes, Michael Farrell, Louisa Degenhardt
Review evidence for cannabinoids as adjunctive treatments for treatment-resistant epilepsy. Systematic search of Medline, Embase and PsycINFO was conducted in October 2017. Outcomes were: 50%+ seizure reduction, complete seizure freedom; improved quality of life (QoL). Tolerability/safety were assessed by study withdrawals, adverse events (AEs) and serious adverse events (SAEs). Analyses were conducted in Stata V.15.0. 36 studies were identified: 6 randomised controlled trials (RCTs), 30 observational studies...
March 6, 2018: Journal of Neurology, Neurosurgery, and Psychiatry
Wilber Su, G Joseph Orme, Robert Hoyt, James Baker, Steven Compton, Christopher Fellows, John Harding, J Thomas Svinarich, Marcin Kowalski, Bryan Piedad, David Kenigsberg, John Seger, Zeshan K Ahmad, Paul Wang
BACKGROUND: Pulmonary vein isolation (PVI) via catheter ablation is an approved therapy for patients with drug-refractory and symptomatic atrial fibrillation (AF). Furthermore, cryoballoon is now considered to be as effective as focal radiofrequency catheter ablation. This study examines the second-generation cryoballoon performance in a US multicenter review of real-world practices. METHODS: By retrospective chart collections, the long-term efficacy and safety of the cryoballoon procedure were assessed in 15 US centers...
February 24, 2018: Journal of Interventional Cardiac Electrophysiology: An International Journal of Arrhythmias and Pacing
Joëlle Elias, Ivo M van Dongen, Truls Råmunddal, Peep Laanmets, Erlend Eriksen, Martijn Meuwissen, H Rolf Michels, Matthijs Bax, Dan Ioanes, Maarten Jan Suttorp, Bradley H Strauss, Emanuele Barbato, Koen M Marques, Bimmer E P M Claessen, Alexander Hirsch, René J van der Schaaf, Jan G P Tijssen, José P S Henriques, Loes P Hoebers
BACKGROUND: During primary percutaneous coronary intervention (PCI), a concurrent chronic total occlusion (CTO) is found in 10% of patients with ST-elevation myocardial infarction (STEMI). Long-term benefits of CTO-PCI have been suggested; however, randomised data are lacking. Our aim was to determine mid-term and long-term clinical outcome of CTO-PCI versus CTO-No PCI in patients with STEMI with a concurrent CTO. METHODS: The Evaluating Xience and left ventricular function in PCI on occlusiOns afteR STEMI (EXPLORE) was a multicentre randomised trial that included 302 patients with STEMI after successful primary PCI with a concurrent CTO...
February 20, 2018: Heart: Official Journal of the British Cardiac Society
Habib Rehman Khan, Ines Kralj-Hans, Shouvik Haldar, Toufan Bahrami, Jonathan Clague, Anthony De Souza, Darrel Francis, Wajid Hussain, Julian Jarman, David Gareth Jones, Neeraj Mediratta, Raad Mohiaddin, Tushar Salukhe, Simon Jones, Joanne Lord, Caroline Murphy, Joanna Kelly, Vias Markides, Dhiraj Gupta, Tom Wong
BACKGROUND: Atrial fibrillation is the commonest arrhythmia which raises the risk of heart failure, thromboembolic stroke, morbidity and death. Pharmacological treatments of this condition are focused on heart rate control, rhythm control and reduction in risk of stroke. Selective ablation of cardiac tissues resulting in isolation of areas causing atrial fibrillation is another treatment strategy which can be delivered by two minimally invasive interventions: percutaneous catheter ablation and thoracoscopic surgical ablation...
February 20, 2018: Trials
T Nijsten, D J Hijnen
Dupilumab is the first and long-awaited biological for treatment of moderate to severe atopic dermatitis. In randomised clinical trials approximately 40% of patients using dupilumab 300 mg every two weeks were clear or almost clear of their eczema after 16 and 52 weeks. We now face the challenge of patient stratification to limit the budget impact of dupilumab and hope that more targeted therapies for atopic dermatitis will follow soon.
2018: Nederlands Tijdschrift Voor Geneeskunde
Matthew J Czarny, Julie M Miller, Daniel Q Naiman, Chao-Wei Hwang, Rani K Hasan, Cynthia C Lemmon, Thomas Aversano
BACKGROUND: The CPORT-E trial showed the noninferiority of nonprimary percutaneous coronary intervention (PCI) at hospitals without cardiac surgery on-site (SoS) compared with hospitals with SoS for 6-week mortality and 9-month major adverse cardiac events (MACE). However, target vessel revascularization (TVR) was increased at non-SoS hospitals. Therefore, we aimed to determine the consistency of the CPORT-E trial findings across the spectrum of enrolled patients. METHODS: Post hoc subgroup analyses of 6-week mortality and 9-month MACE, defined as the composite of death, Q-wave myocardial infarction, or TVR, were performed...
March 2018: American Heart Journal
Emma D Deeks
Denosumab (Prolia®; Pralia®) is a human monoclonal antibody targeting the key bone resorption mediator RANKL. The drug is administered via subcutaneous injection once every 6 months and is approved for various indications, including the treatment of postmenopausal (PM) women with osteoporosis at increased/high risk of fracture or failure/intolerance of other osteoporosis therapies (indications featured in this review). Denosumab showed benefit in several phase 3 or 4 studies in PM women with osteoporosis or low bone mineral density (BMD), including the pivotal 3-year double-blind FREEDOM trial and its 7-year open-label extension...
February 12, 2018: Drugs & Aging
Zachary M Grinspan, Renée A Shellhaas, Jason Coryell, Joseph E Sullivan, Elaine C Wirrell, John R Mytinger, William D Gaillard, Eric H Kossoff, Ignacio Valencia, Kelly G Knupp, Courtney Wusthoff, Cynthia Keator, Nicole Ryan, Tobias Loddenkemper, Catherine J Chu, Edward J Novotny, John Millichap, Anne T Berg
Importance: More than half of infants with new-onset epilepsy have electroencephalographic and clinical features that do not conform to known electroclinical syndromes (ie, nonsyndromic epilepsy). Levetiracetam and phenobarbital are the most commonly prescribed medications for epilepsy in infants, but their comparative effectiveness is unknown. Objective: To compare the effectiveness of levetiracetam vs phenobarbital for nonsyndromic infantile epilepsy. Design, Setting, and Participants: The Early Life Epilepsy Study-a prospective, multicenter, observational cohort study conducted from March 1, 2012, to April 30, 2015, in 17 US medical centers-enrolled infants with nonsyndromic epilepsy and a first afebrile seizure between 1 month and 1 year of age...
February 12, 2018: JAMA Pediatrics
Ping Yi Chan, Zaidi Mohd Ripin, Sanihah Abdul Halim, John Tharakan, Mustapha Muzaimi, Kwang Sheng Ng, Muhammad Imran Kamarudin, Gaik Bee Eow, Jyh Yung Hor, Kenny Tan, Chun Fai Cheah, Nelson Soong, Linda Then, Ahmad Shukri Yahya
Despite the advancement of the tremor assessment systems, the current technology still lacks a method that can objectively characterize tremors in relative segmental movements. This paper presents a measurement system, which quantifies multi-degrees-of-freedom coupled relative motions of hand-arm tremor, in terms of joint angular displacement. In-laboratory validity and reliability tests of the system algorithm to provide joint angular displacement was carried out by using the two-degrees-of-freedom tremor simulator with incremental rotary encoder systems installed...
February 2018: IEEE Transactions on Neural Systems and Rehabilitation Engineering
Dominik Wiedemann, Veronika Rupprechter, Julia Mascherbauer, Andreas Kammerlander, Bruno Mora, Kamen Dimitrov, Benedikt Weber, Martin Andreas, Günther Laufer, Alfred Kocher
BACKGROUND: Replacement of the tricuspid valve is uncommon. Prostheses specifically designed for the this position are not available. Bovine, porcine as well as mechanical valve prostheses are currently used, however, the most suitable prosthesis type has not been defined. METHODS: We retrospectively analyzed all consecutive patients who underwent tricuspid valve replacement (TVR) at the Medical University of Vienna from 1996 to 2014. Baseline patient characteristics, prosthesis type, and postoperative outcome data were collected...
February 8, 2018: Journal of Cardiovascular Surgery
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