Author + information
- Received November 5, 2018
- Revision received December 7, 2018
- Accepted December 17, 2018
- Published online March 18, 2019.
- Paul Sorajja, MDa,∗ (, )@PSorajja,
- Neil Moat, MBBSb,
- Vinay Badhwar, MDc,
- Darren Walters, MBBSd,
- Gaetano Paone, MDe,
- Brian Bethea, MDf,
- Richard Bae, MDa,
- Gry Dahle, MDg,
- Mubashir Mumtaz, MDh,
- Paul Grayburn, MDi,
- Samir Kapadia, MDj,
- Vasilis Babaliaros, MDk,
- Mayra Guerrero, MDl,
- Lowell Satler, MDm,
- Vinod Thourani, MDm,
- Francesco Bedogni, MDn,
- David Rizik, MDo,
- Paolo Denti, MDp,
- Nicolas Dumonteil, MDq,
- Thomas Modine, MDr,
- Ajay Sinhal, MBBSs,
- Michael L. Chuang, MDt,
- Jeffrey J. Popma, MDt,
- Philipp Blanke, MDu,
- Jonathon Leipsic, MDu and
- David Muller, MBBSv
- aValve Science Center, Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital, Minneapolis, Minnesota
- bRoyal Brompton Hospital, London, United Kingdom
- cWest Virginia University Heart and Vascular Institute, Morgantown, West Virginia
- dPrince Charles Hospital, Brisbane, Australia
- eHenry Ford Hospital, Detroit, Michigan
- fDelray Medical Center, Delray Beach, Florida
- gOslo University Hospital, Oslo, Norway
- hUniversity of Pittsburg Medical Center Pinnacle, Harrisburg, Pennsylvania
- iBaylor University Medical Center, Dallas, Texas
- jCleveland Clinic Foundation, Cleveland, Ohio
- kEmory University Hospital, Atlanta, Georgia
- lMayo Clinic, Rochester, Minnesota
- mMedstar Washington Hospital Center, Washington, DC
- nPoliclinico San Donato, Milan, Italy
- oHonor Health, Scottsdale, Arizona
- pOspedale San Raffaele, Milan, Italy
- qClinique Pasteur, Toulouse, France
- rCHRU Lille, Lille, France
- sFlinders University Hospital, Adelaide, Australia
- tBeth Israel Deaconess Medical Center, Boston, Massachusetts
- uSt Paul’s Hospital, Vancouver, British Columbia, Canada
- vSt. Vincent’s Hospital, Sydney, Australia
- ↵∗Address for correspondence:
Dr. Paul Sorajja, Valve Science Center, Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, 920 East 28th Street, Suite 200, Minneapolis, Minnesota 55407.
Background Transcatheter mitral valve replacement (TMVR) is a rapidly evolving therapy. Follow-up of TMVR patients remains limited in duration and number treated.
Objectives The purpose of this study was to examine outcomes with expanded follow-up for the first 100 patients who underwent TMVR with the prosthesis.
Methods The Global Feasibility Study enrolled symptomatic patients with either primary or secondary mitral regurgitation (MR) who were at high or prohibitive surgical risk. The present investigation examines the first 100 patients treated in this study. Clinical outcomes through last clinical follow-up were adjudicated independently.
Results In the cohort (mean age 75.4 ± 8.1 years; 69% men), there was a high prevalence of severe heart failure symptoms (66%), left ventricular dysfunction (mean ejection fraction 46.4 ± 9.6%), and morbidities (Society of Thoracic Surgeons Predicted Risk of Mortality, 7.8 ± 5.7%). There were no intraprocedural deaths, 1 instance of major apical bleeding, and no acute conversion to surgery or need for cardiopulmonary bypass. Technical success was 96%. The 30-day rates of mortality and stroke were 6% and 2%, respectively. The 1-year survival free of all-cause mortality was 72.4% (95% confidence interval: 62.1% to 80.4%), with 84.6% of deaths due to cardiac causes. Among survivors at 1 year, 88.5% were New York Heart Association function class I/II, and improvements in 6-min walk distance (p < 0.0001) and quality-of-life measurements occurred (p = 0.011). In 73.4% of survivors, the Kansas City Cardiomyopathy Questionnaire score improved by ≥10 points.
Conclusions In this study of TMVR, which is the largest experience to date, the prosthesis was highly effective in relieving MR and improving symptoms, with an acceptable safety profile. Further study to optimize the impact on long-term survival is needed.
Dr. Sorajja has served as a consultant for Abbott Structural, Boston Scientific, Medtronic, Edwards, Admedus, and Gore; and has received research grants from Abbott Structural, Boston Scientific, and Medtronic. Dr. Moat has served as a consultant and on the Speakers Bureau for Abbott Vascular, Medtronic, and Edwards Lifesciences. Dr. Badhwar has served as an uncompensated consultant for Abbott Vascular. Dr. Walters has served as a consultant and proctor for Edwards Lifesciences, Boston Scientific, and Abbott Vascular. Dr. Paone has served as a consultant for Edwards Lifesciences. Dr. Bethea has served as a consultant, proctor, and is on the speaker's bureau for Abbott Vascular and Medtronic. Drs. Bae and Dahle have served on the Speakers Bureau for Abbott Vascular. Dr. Mumtaz has served as a consultant for and received grant support from Abbott Vascular, Medtronic, Millipede, Terumo, Atricure, Edwards Lifesciences, Japanese Organization for Medical Device Development, Keystone, and Boston Scientific. Dr. Grayburn has received grant support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Medtronic, and Neochord; has served as a consultant for Abbott Vascular, Edwards Lifesciences, Medtronic, and Neochord; and has received core laboratory support from Edwards Lifesciences and Neochord. Dr. Kapadia has stock options in Navigate. Dr. Babaliaros has served as a consultant and researcher for Edwards Lifesciences and Abbott Vascular. Dr. Guerrero has served as a proctor for and received research support from Edwards Lifesciences; and has served as a consultant and is on the Speakers Bureau for Boston Scientific. Dr. Thourani has served as a consultant for Abbott Vascular. Dr. Bedogni has served as a consultant for Abbott Vascular, Medtronic, Boston Scientific, and Terumo. Dr. Rizik has served on the Advisory Board for Abbott Vascular, Cordis/Cardinal, Biotronik, and Boston Scientific; has received grant or research support from Abbott Vascular and Boston Scientific; and has received licensing fees from Boston Scientific. Dr. Denti has served as a consultant for and received speaker honoraria from Abbott Vascular. Dr. Dumonteil has served as a consultant and proctor for Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr. Sinhal has served as a proctor and consultant for Edwards Lifesciences, Medtronic, and Boston Scientific. Dr. Popma has received institutional grants from Abbott, Medtronic, Edwards, and Boston Scientific; and has served on the Medical Advisory Board of Boston Scientific. Dr. Blanke has served as a consultant for Abbott Vascular, Circle Cardiovascular Imaging, Edwards Lifesciences, Tendyne, and Neovasc. Dr. Leipsic has served as a consultant for and has stock options in Circle Cardiovascular Imaging and HeartFlow; and has core laboratory agreements with Abbott Vascular, Medtronic, and Edwards Lifesciences. Dr. Muller has served as a consultant for Abbott and Cephea; has received research support from Medtronic, Tendyne, and Cephea; has served as a proctor for Medtronic; and has served on the Advisory Board of Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Listen to this manuscript's audio summary by Editor-in-Chief Dr. Valentin Fuster on JACC.org.
- Received November 5, 2018.
- Revision received December 7, 2018.
- Accepted December 17, 2018.
- 2019 American College of Cardiology Foundation
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