Author + information
- Received October 17, 2017
- Revision received October 24, 2017
- Accepted October 24, 2017
- Published online January 1, 2018.
- Vinayak Bapat, MBBS, MS, MCha,b,
- Vivek Rajagopal, MDc,
- Christopher Meduri, MD, MPHc,
- R. Saeid Farivar, MDd,
- Antony Walton, MDe,
- Stephen J. Duffy, MBBS, PhDe,
- Robert Gooley, MBBS, PhDf,
- Aubrey Almeida, MDf,
- Michael J. Reardon, MDg,
- Neal S. Kleiman, MDg,
- Konstantinos Spargias, MDh,
- Stratis Pattakos, MDh,
- Martin K. Ng, MBBS, PhDi,
- Michael Wilson, MDi,
- David H. Adams, MDj,
- Martin Leon, MDb,
- Michael J. Mack, MDk,
- Sharla Chenoweth, MSl,
- Paul Sorajja, MDd,∗ (, )
- for the Intrepid Global Pilot Study Investigators∗
- aSt. Thomas’ Hospital, London, United Kingdom
- bNew York Presbyterian/Columbia University Medical Center, New York, New York
- cPiedmont Heart Institute, Atlanta, Georgia
- dAbbott Northwestern Hospital, Minneapolis, Minnesota
- eCardiology Department, The Alfred, Melbourne, Australia
- fMonash Heart, Melbourne, Australia
- gHouston Methodist DeBakey Heart and Vascular Center, The Methodist Hospital, Houston, Texas
- hHygeia Hospital, Athens, Greece
- iRoyal Prince Alfred Hospital, Sydney, Australia
- jMount Sinai Medical Center, New York, New York
- kBaylor Scott & White Health, Plano, Texas
- lMedtronic, Minneapolis, Minnesota
- ↵∗Address for correspondence:
Dr. Paul Sorajja, Valve Science Center, Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, 800 East 28th Street, Minneapolis, Minnesota 55401.
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)
The Intrepid Global Pilot Study was funded by Medtronic (Minneapolis, Minnesota). Dr. Bapat has received personal fees for consultancy and speaker service from Medtronic. Dr. Rajagopal has received personal fees for speaking from Medtronic, Boston Scientific, and Abbott Vascular; and is on the screening committee for the APOLLO trial sponsored by Medtronic. Dr. Meduri has received grant support paid to his institution from Medtronic; and is a consultant to Boston Scientific and Mitralign. Dr. Walton has received proctor and advisory board fees from Medtronic unrelated to the submitted work. Dr. Duffy has received research support paid to his institution from Medtronic; and receives proctor fees from Medtronic unrelated to the submitted work. Dr. Gooley has received proctor fees from Medtronic unrelated to the submitted work. Dr. Reardon has received personal fees from Medtronic and Boston Scientific outside the submitted work. Dr. Kleiman has received proctoring fees from Medtronic. Dr. Spargias has received grant support and personal fees for travel from Medtronic. Dr. Pattakos has received grant support from Medtronic and Edwards. Dr. Ng reports fees paid to his institution for research participation. Dr. Adams has received grant support from Medtronic; and royalty agreements through Mount Sinai School of Medicine with Medtronic and Edwards Lifesciences. Dr. Mack is on the Executive Board for the APOLLO trial sponsored by Medtronic; and is coprincipal investigator for the Partner 3 and COAPT trials sponsored by Edwards and Abbott Vascular. Ms. Chenoweth is an employee of Medtronic. Dr. Sorajja has received grant support from Medtronic for participation in the Steering Committee of the APOLLO trial. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Deepak L. Bhatt, MD, MPH, and Ted Feldman, MD, served as Guest Editors.
- Received October 17, 2017.
- Revision received October 24, 2017.
- Accepted October 24, 2017.
- 2018 American College of Cardiology Foundation
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