Vinayak Bapat1, Vivek Rajagopal2, Christopher Meduri2, R Saeid Farivar3, Antony Walton4, Stephen J Duffy4, Robert Gooley5, Aubrey Almeida5, Michael J Reardon6, Neal S Kleiman6, Konstantinos Spargias7, Stratis Pattakos7, Martin K Ng8, Michael Wilson8, David H Adams9, Martin Leon10, Michael J Mack11, Sharla Chenoweth12, Paul Sorajja13. 1. St. Thomas' Hospital, London, United Kingdom; New York Presbyterian/Columbia University Medical Center, New York, New York. 2. Piedmont Heart Institute, Atlanta, Georgia. 3. Abbott Northwestern Hospital, Minneapolis, Minnesota. 4. Cardiology Department, The Alfred, Melbourne, Australia. 5. Monash Heart, Melbourne, Australia. 6. Houston Methodist DeBakey Heart and Vascular Center, The Methodist Hospital, Houston, Texas. 7. Hygeia Hospital, Athens, Greece. 8. Royal Prince Alfred Hospital, Sydney, Australia. 9. Mount Sinai Medical Center, New York, New York. 10. New York Presbyterian/Columbia University Medical Center, New York, New York. 11. Baylor Scott & White Health, Plano, Texas. 12. Medtronic, Minneapolis, Minnesota. 13. Abbott Northwestern Hospital, Minneapolis, Minnesota. Electronic address: paul.sorajja@allina.com.
Abstract
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).
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).
Authors: Keshav Kohli; Zhenglun Alan Wei; Ajit P Yoganathan; John N Oshinski; Jonathon Leipsic; Philipp Blanke Journal: Curr Treat Options Cardiovasc Med Date: 2018-10-26
Authors: Jaffar M Khan; Vasilis C Babaliaros; Adam B Greenbaum; Jason R Foerst; Shahram Yazdani; James M McCabe; Gaetano Paone; Marvin H Eng; Bradley G Leshnower; Patrick T Gleason; Marcus Y Chen; Dee Dee Wang; Xin Tian; Annette M Stine; Toby Rogers; Robert J Lederman Journal: J Am Coll Cardiol Date: 2019-05-28 Impact factor: 24.094
Authors: Adam S Evans; Menachem M Weiner; Shahzad Shaefi; Prakash A Patel; Matthew M Townsley; Abirami Kumaresan; Jared W Feinman; Ashley V Fritz; Archer K Martin; Toby B Steinberg; J Ross Renew; Jane L Gui; Brian Radvansky; Himani Bhatt; Sudhakar Subramani; Archit Sharma; Jacob T Gutsche; John G Augoustides; Harish Ramakrishna Journal: J Cardiothorac Vasc Anesth Date: 2019-11-09 Impact factor: 2.628