Background: Transcatheter mitral valve replacement (TMVR) is a potential therapy for patients with symptomatic, severe mitral regurgitation (MR). The feasibility of this therapy remains to be defined.
Objectives: The authors report their early experience with TMVR using a new valve system.
Methods: The valve is a self-expanding, nitinol valve with bovine pericardial leaflets that is placed using a transapical delivery system. Patients with symptomatic MR who were deemed high or extreme risk by the local heart teams were enrolled in a global pilot study at 14 sites (United States, Australia, and Europe).
Results: Fifty consecutively enrolled patients (mean age: 73 ± 9 years; 58.0% men; 84% secondary MR) underwent TMVR with the valve. The mean Society for Thoracic Surgery score was 6.4 ± 5.5%; 86% of patients were New York Heart Association functional class III or IV, and the mean left ventricular ejection fraction was 43 ± 12%. Device implant was successful in 48 patients with a median deployment time of 14 min (interquartile range: 12 to 17 min). The 30-day mortality was 14%, with no disabling strokes, or repeat interventions. Median follow-up was 173 days (interquartile range: 54 to 342 days). At latest follow-up, echocardiography confirmed mild or no residual MR in all patients who received implants. Improvements in symptom class (79% in New York Heart Association functional class I or II at follow-up; p < 0.0001 vs. baseline) and Minnesota Heart Failure Questionnaire scores (56.2 ± 26.8 vs. 31.7 ± 22.1; p = 0.011) were observed.
Conclusions: TMVR with the valve was feasible in a study group at high or extreme risk for conventional mitral valve replacement. These results inform trial design of TMVR in lower-risk patients with severe mitral valve regurgitation (Evaluation of the Safety and Performance of the Twelve Intrepid Transcatheter Mitral Valve Replacement System in High Risk Patients with Severe, Symptomatic Mitral Regurgitation - The Twelve Intrepid TMVR Pilot Study; NCT02322840).
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http://dx.doi.org/10.1016/j.jacc.2017.10.061 | DOI Listing |
Diabetol Metab Syndr
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Serviço de Endocrinologia (SEMPR) do Hospital das Clínicas da Universidade Federal do Paraná (UFPR), Curitiba, Brazil.
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Department of Radiology and Tianjin Key Lab of Functional Imaging and Tianjin Institute of Radiology and State Key Laboratory of Experimental Hematology, Tianjin Medical University General Hospital, Tianjin, 300052, China.
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NIHR Greater Manchester Patient Safety Research Collaboration, Centre for Primary Care & Health Services Research, School of Health Sciences, Faculty of Biology, Medicine & Health, The University of Manchester, Greater Manchester, England, UK.
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Hannover Medical School (MHH), Institute for Epidemiology, Social Medicine and Health Systems Research, Carl-Neuberg-Street 1, 30625, Hannover, Germany.
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Pathology and Lab Medicine, AIIMS Jodhpur, Jodhpur, Rajasthan, India.
Myoepithelial tumours are rare and distinct entities with uncertain histogenesis. They occur primarily in major salivary glands and soft tissue around the head and neck. Bony involvement predominantly occurs in facial bones.
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