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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DiscussionOur study demonstrated the robustness of a multisite Centiloid [11C]PIB-PET study and established a range of pathology-based CL thresholds.
Source: Alzheimer's and Dementia: The Journal of the Alzheimer's Association - Category: Geriatrics Source Type: research
CONCLUSIONSPanoramic imaging has low efficacy in the diagnosis of sinus disease, even when examined by experienced dental radiologists. OPG can be useful in excluding disease, but three-dimensional scanning is necessary for the definitive investigation of sinus lesions.
Source: Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology - Category: ENT & OMF Source Type: research
ConclusionsBecause of the overlapping of buccal and lingual cortices, panoramic images are especially inadequate for determining the C3 category of MCI. However, CS images obtained from available CBCT data provide better visibility than panoramic images and can, therefore, be used for evaluating mandibular indices.
Source: Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology - Category: ENT & OMF Source Type: research
Publication date: Available online 19 October 2018Source: Journal of Cranio-Maxillofacial SurgeryAuthor(s): Anada Amaral Santos, Fernanda Paula Yamamoto-Silva, Erica Miranda Torres, José Valladares-Neto, Paulo Tadeu Souza Figueiredo, André Ferreira Leite, Maria Alves garcia SilvaSummaryThe aim of this study was to evaluate the contribution of cone-beam computed tomography (CBCT) in the decision of surgical management for bone lesions of the maxillofacial region. It is a retrospective cross-sectional observational study that includes a sample of panoramic radiography (PR) and CBCT from patients with some type ...
Source: Journal of Cranio Maxillofacial Surgery - Category: ENT & OMF Source Type: research
ConclusionEnteric contrast is used in a minority of respondents ’ centers for penetrating trauma cases, which is likely driven by a perceived lack of added benefit and delays in patient care.
Source: Emergency Radiology - Category: Emergency Medicine Source Type: research
CONCLUSIONS: Platelet-mediated thromboembolism following MAP installation can be treated with antiplatelet agents. The 16-year results of the present study suggested that antiplatelet agents can reduce thromboembolic events in patients with MAP. Strokes can be prevented in patients with MAP if treated with the correct antiplatelet agent, if the patient responds to the agent employed and is strictly compliant. PMID: 30207122 [PubMed - in process]
Source: Journal of Heart Valve Disease - Category: Cardiology Tags: J Heart Valve Dis 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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