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LivaNova launches post-market study of bioprosthetic aortic heart valves

LivaNova (NSDQ:LIVN) announced today that the first patient has been enrolled in a post-market trial evaluating the overall incidence of reduced leaflet motion identified by CT imaging in patients receiving a bioprosthetic aortic heart valve. Four-dimensional CT scans will be taken of the trial’s 230 participants at least 30 days after they stop anticoagulation or dual antiplatelet therapy, according to LivaNova. The study will also include one year of follow-up. “Thrombus formation on valve leaflets has been shown to occur in some patients receiving prosthetic tissue valve replacement via transcatheter or open surgical procedures and may lead to leaflet thickening and immobility,” Brian Duncan, LivaNova’s VP of medical affairs in cardiac surgery, said in prepared remarks. “Believe is the first trial to examine this process with advanced imaging and a standardized approach to anticoagulation in patients undergoing implantation of LivaNova bioprosthetic aortic valves.” “The Believe study is designed to enhance the understanding of reduced leaflet motion phenomenon, while providing important information to clinicians and patients to ensure the best possible outcomes after surgical aortic valve replacement,” Dr. Basel Ramlawi, who enrolled the first patient in the trial and is the attending cardiothoracic surgeon and chairman of The Heart &Vascular Center at Valley Health System, added. London-based LivaNova also said toda...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiovascular Clinical Trials Imaging Wall Street Beat LivaNova Source Type: news

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We describe the technique and interpretation of commercially available VET and assess the application of VET in both transplant and non-transplant cirrhosis populations. VET largely correlates well with traditional testing including platelet count and fibrinogen level, however, is potentially less accurate in patients with low fibrinogen levels. VET may be useful in identifying patients at higher risk of hypercoagulable complications post-transplant and reflects changes in hemostasis in decompensated patients. While VET has been associated with decreased transfusión support in multiple studies, the lack of bleeding ...
Source: Annals of Hepatology - Category: Gastroenterology Tags: Ann Hepatol Source Type: research
Authors: Van Hoecke H, Calus L, Dhooge I Abstract Middle ear damages. The eardrum and middle ear are often exposed to blunt and penetrating trauma, blasts, thermal or caustic injuries. These injuries may result in tympanic membrane perforation, middle ear haemorrhage, dislocation and fracture of the ossicular chain, perilymphatic fistula and damage to the chorda tympani and/or facial nerve. In case of life-threatening injuries and/or mass casualty incidents, middle ear trauma obviously does not take highest priority. However, middle ear lesions should be suspected and recognized as early as possible. After meticulo...
Source: B-ENT - Category: ENT & OMF Tags: B-ENT Source Type: research
Conclusions: A linear relationship was observed between surgical timing and 1-year mortality. Each 10-hour delay from admission to surgery was associated with an estimated 5% higher odds of 1-year mortality. Therefore, we suggest that hip fractures should be treated urgently similar to other time-sensitive pathology such as stroke and myocardial ischemia. Level of Evidence: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.
Source: Journal of Orthopaedic Trauma - Category: Orthopaedics Tags: Original Article Source Type: research
Conclusions: In this cohort of patients with operative tibial plateau fractures, sutured lateral meniscal tears, untreated medial meniscus tears, and complete MCL ruptures did not significantly affect clinical outcomes. In addition, these data suggest that obtaining a preoperative MRI in patients with tibial plateau fractures to diagnose soft tissue injuries may not alter the surgical treatment or alter patient prognosis for midterm outcomes. Level of Evidence: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.
Source: Journal of Orthopaedic Trauma - Category: Orthopaedics Tags: Original Article Source Type: research
Objectives: To characterize the in vitro toxicity of vancomycin on articular cartilage. Methods: Osteochondral samples extracted from fresh, juvenile porcine stifle (knee) joints were exposed to vancomycin saline concentrations of 2, 5, and 10 mg/mL and compared with a saline and nonsaline treated control. Comparison of chondrocyte viability was assessed with histology examination of chondrocyte degeneration using the Mankin criteria and a live/dead staining using ethidium homodimer-2 and calcien acetoxymethylester stain and confocal laser scanning microscopy. Results: A comparison of chondrocyte viability in the c...
Source: Journal of Orthopaedic Trauma - Category: Orthopaedics Tags: Original Article Source Type: research
Purpose: To compare the visualization of the macula between spectral domain optical coherence tomography (SD-OCT) and swept-source OCT (SS-OCT) in gas-filled eyes. Methods: Sixty-one patients with common indications of gas tamponade, including 27 with macular holes and 34 with rhegmatogenous retinal detachment, who were treated with vitrectomy and gas tamponade were imaged using both SD-OCT (3D-OCT 2000, Topcon, Tokyo, Japan) and SS-OCT (DRI-OCT, Topcon) at 1, 3, and 7 days after the surgery. Good visualization of the macular area was defined as 1) visible foveal contour and discriminable status of hole (open or close...
Source: RETINA - Category: Opthalmology Tags: Original Study Source Type: research
Authors: Robson A, Sturman J, Williamson P, Conboy P, Penney S, Wood H Abstract This is the official guideline endorsed by the specialty associations involved in the care of head and neck cancer patients in the UK. This paper provides recommendations on the pre-treatment clinical assessment of patients presenting with head and neck cancer. Recommendations • Comorbidity data should be collected as it is important in the analysis of survival, quality of life and functional outcomes after treatment as well as for comparing results of different treatment regimens and different centres. (R) • Patients with hyp...
Source: Journal of Laryngology and Otology - Category: ENT & OMF Tags: J Laryngol Otol Source Type: research
In this study, cangrelor was discontinued 1-6 hours prior to surgery, while aspirin was continued throughout the perioperative period. Bridging with cangrelor did not increase major bleeds prior to surgery, though minor bleeds, mostly ecchymosis at venipuncture site, was higher. P2Y12 assay documented sufficient platelet inhibition corresponding to levels required for anti thrombotic effect [1]. Cangrelor is awaiting approval and more large scale trials regarding the use of bridging are needed. Reference 1. Angiolillo DJ et al; BRIDGE Investigators. Bridging antiplatelet therapy with cangrelor in patients undergoing ...
Source: Cardiophile MD - Category: Cardiology Authors: Tags: Cardiology MCQ DM / DNB Cardiology Entrance Source Type: blogs
Conclusion The JenaValve transapical TAVI system is a safe and feasible procedure with low peri- and postoperative complications and convincing midterm performance of the prosthesis. PMID: 26030120 [PubMed - as supplied by publisher]
Source: The Thoracic and Cardiovascular Surgeon - Category: Cardiovascular & Thoracic Surgery Authors: Tags: Thorac Cardiovasc Surg Source Type: research
Conclusion The JenaValve transapical TAVI system is a safe and feasible procedure with low peri- and postoperative complications and convincing midterm performance of the prosthesis.[...]Georg Thieme Verlag KG Stuttgart · New YorkArticle in Thieme eJournals:Table of contents  |  Abstract  |  Full text
Source: The Thoracic and Cardiovascular Surgeon - Category: Cardiovascular & Thoracic Surgery Authors: Tags: Original Cardiovascular Source Type: research
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