Author + information
- Received October 17, 2017
- Revision received October 24, 2017
- Accepted October 24, 2017
- Published online November 1, 2017.
- Vinayak Bapat, FRCSa,
- Vivek Rajagopal, MDb,
- Christopher Meduri, MD, MPHb,
- R. Saeid Farivar, MDc,
- Antony Walton, MDd,
- Stephen J. Duffy, MBBS, PhDd,
- Robert Gooley, MBBS, PhDe,
- Aubrey Almeida, MDe,
- Michael J. Reardon, MDf,
- Neal S. Kleiman, MDf,
- Konstantinos Spargias, MDg,
- Stratis Pattakos, MDg,
- Martin K. Ng, MBBS, PhDh,
- Michael Wilson, MDh,
- David H. Adams, MDi,
- Martin Leon, MDj,
- Michael J. Mack, MDk,
- Sharla Chenoweth, MSl,
- Paul Sorajja, MDc,∗ (, )
- for the Intrepid Global Pilot Study Investigators∗
- aSt. Thomas’ Hospital, London, United Kingdom and New York Presbyterian/Columbia University Medical Center, New York, NY, USA
- bPiedmont Heart Institute Atlanta, GA, USA
- cAbbott Northwestern Hospital, Minneapolis, MN, USA
- dCardiology Department, The Alfred, Melbourne, Australia
- eMonash Heart,, Melbourne, Australia
- fHouston Methodist DeBakey Heart and Vascular Center, The Methodist Hospital, Houston, TX, USA
- gHygeia Hospital, Athens, Greece
- hRoyal Prince Alfred Hospital, Sydney, Australia
- iMount Sinai Medical Center, New York, NY
- jColumbia University Medical Center/NY Presbyterian Hospital, New York, NY
- kBaylor Scott & White Health, Plano, TX, USA
- lMedtronic, Minneapolis, MN, USA
- ↵∗Address for correspondence: Paul Sorajja, MD Roger L. and Lynn C. Headrick Chair, Valve Science Center Minneapolis Heart Institute Foundation Abbott Northwestern Hospital Minneapolis, MN 55407 Telephone: 612-863-8751 Fax: 6128631681.
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.
Objective We report our 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 (U.S., Australia, and Europe).
Results 50 consecutively enrolled patients (mean age, 73±9 years; 58.0% men; 84% secondary MR) underwent TMVR with the valve. The mean STS score was 6.4±5.5%; 86% of patient were NYHA 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 (IQR, 12, 17) minutes. The 30-day mortality was 14%, with no disabling strokes, or repeat interventions. Median follow-up was 173 (IQR, 54, 342) days. At latest follow-up, echocardiography confirmed mild or no residual MR in all implanted patients. Improvements in symptom class (79% in NYHA 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 population 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.
↵∗ Intrepid Global Pilot Study Investigators are listed at the end of the Article
Relationship with industry: VB receives personal fees for consultancy and speaker service from Medtronic. VR receives personal fees for speaking from Medtronic and is on the screening committee for the APOLLO trial sponsored by Medtronic. CM receives grant support paid to his institution from Medtronic and is consultant to Boston Scientific and Mitralign. RSF has nothing to declare related to the submitted work. AW receives proctor and advisory board fees from Medtronic unrelated to the submitted work. SJD receives research support paid to his institution from Medtronic and receives proctor fees from Medtronic unrelated to the submitted work. RG receives proctor fees from Medtronic unrelated to the submitted work. MJR receives personal fees from Medtronic and Boston Scientific outside the submitted work. NSK receives proctoring fees from Medtronic receives proctor fees from Medtronic. KS receives grant support and personal fees for travel from Medtronic. SP receives grant support from Medtronic. MN reports fees paid to the institution for research participation. DHA reports receiving grant support from Medtronic and royalty agreements through Mount Sinai School of Medicine with Medtronic and Edwards Lifesciences. MJM is on the Executive Board for the APOLLO trial sponsored by Medtronic and is co-principal investigator for the Partner 3 and COAPT trials sponsored by Edwards and Abbott Vascular; he receives no personal fees. SC is an employee of Medtronic. PS receives grant support from Medtronic for participation in the Steering Committee of the APOLLO trial. AA, MW, ML have no declarations of interests.
Clinical Trial: NCT02322840
- Received October 17, 2017.
- Revision received October 24, 2017.
- Accepted October 24, 2017.