Author + information
- Received September 15, 2019
- Accepted September 17, 2019
- Published online October 17, 2019.
- Federico M. Asch, MDa,∗ (, )@FedericoAsch,
- Paul A. Grayburn, MDb,
- Robert J. Siegel, MDc,
- Saibal Kar, MDc,
- D. Scott Lim, MDd,
- Jonathan G. Zaroff, MDe,
- Jacob M. Mishell, MDe,
- Brian Whisenant, MDf,
- Michael J. Mack, MDg,
- JoAnn Lindenfeld, MDh,
- William T. Abraham, MDi,
- Gregg W. Stone, MDj,
- Neil J. Weissman, MDa,
- on behalf of the COAPT Investigators
- aMedStar Health Research Institute, Washington, DC
- bBaylor University Medical Center, Baylor Heart and Vascular Institute, Dallas, TX
- cCedars-Sinai Smidt Heart Institute, Los Angeles, CA
- dDivision of Cardiology, University of Virginia, Charlottesville, VA
- eKaiser Permanente - San Francisco Hospital, San Francisco, CA
- fIntermountain Medical Center, Murray, UT
- gBaylor Scott & White Heart and Vascular Hospital, Plano, TX
- hAdvanced Heart Failure, Vanderbilt Heart and Vascular Institute, Nashville, TN
- IDepartments of Medicine, Physiology, and Cell Biology, Division of Cardiovascular Medicine, and the Davis Heart and Lung Research Institute, The Ohio State University, Columbus, OH
- jThe Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York and The Cardiovascular Research Foundation, New York, NY
- ↵∗Corresponding Author: Federico M. Asch, MD, MedStar Health Research Institute at MedStar, Washington Hospital Center, 100 Irving St, NW, Suite EB 5123, Washington, DC 20010, Phone (o):(202) 877-3792, Phone (Cell): (301) 654-5645, Fax: (202) 877-0792.
Background In the COAPT trial among patients with heart failure (HF) and moderate-to-severe (3+) or severe (4+) secondary mitral regurgitation (SMR), patients treated with the transcatheter mitral valve replacement (TMVR) had reduced rates of HF hospitalization and mortality compared with guideline-directed medical therapy (GDMT) alone.
Objectives To describe the echocardiographic patient qualification process for COAPT, baseline echocardiographic characteristics, changes over time, and the interaction between treatment group and echocardiographic parameters on clinical outcomes.
Methods A novel echocardiographic algorithm was implemented for grading MR severity during the screening process. Standardized echocardiograms were obtained at baseline and during regular follow-up intervals through 2 years, and analyzed by a core laboratory.
Results A total of 614 patients were randomized to TMVR plus maximally- tolerated GDMT or GDMT alone. Mean baseline left ventricular ejection fraction (LVEF) was 31.3±9.3%, LV end-diastolic volume was 192.7±71 ml, and effective regurgitant orifice area was 0.41±0.15 cm2. The beneficial effect of TMVR compared with GDMT alone was consistent in all echocardiographic subgroups, independent of the severity of LV dysfunction, LV dilatation, pulmonary hypertension, severity of tricuspid regurgitation or individual MR characteristics. The LVEF decreased and the LV volumes progressively increased in both groups during follow-up, although less after TMVR (P<0.05).
Conclusions HF patients in the COAPT trial with 3+ or 4+ SMR, selected using strict echocardiographic criteria, benefitted from TMVR with reduced 2-year rates of death and HF hospitalization. Strict application of these echocardiographic criteria should enable the COAPT results to be translated to clinical practice.
- Secondary mitral regurgitation
- heart failure
- percutaneous mitral valve repair
- mitral valve edge-to-edge repair
- clinical outcomes
Funding: The COAPT trial was sponsored by Abbott and designed collaboratively by the principal investigators and the sponsor.
Tweet #1: The COAPT echocardiographic screening algorithm should be used for selection of heart failure patients with secondary MR to identify patients likely to benefit from MitraClip implantation.
Tweet #2: Echocardiography is critical for identifying patients with heart failure and secondary MR who may achieve COAPT-trial consistent results in clinical practice.
Tweet #3: In COAPT, all major echocardiography-based subgroups responded to MitraClip with consistently lower rates of death or HF hospitalization compared with guideline directed medical therapy alone.
Disclosure of Potential Conflicts of Interest:
FMA: Director of an academic echocardiography core lab (MedStar Health Research Institute) with Institutional contracts with Abbott, Neovasc, Ancora, Mitralign, Medtronic, Boston Scientific, Edwards Lifesciences, Biotronik, Livanova.
PAG: research grant support from Abbott, Edwards Lifesciences, Medtronic and Boston
Scientific, Consultant for Abbott, Edwards, Medtronic, Neochord, Imaging Core Lab Contracts from Edwards Lifesciences, Neochord, W. L. Gore, Cardiovalve.
RJS: speaker fees from Philips Ultrasound
SK: research grant support from Abbott, Boston Scientific, Edwards Lifesciences, Mitralign;
consulting income from Abbott and Boston Scientific
DSL: research grant support from Abbott; consulting income from Abbott
BW: consultant for Edwards Lifesciences and Boston Scientific
JL: research grant support from AstraZeneca; consulting income from Abbott, Edwards
Lifesciences, Boston Scientific, Relypsa, Boehringer Ingelheim, V-Wave, CVRx, Impulse Dynamics.
WTA: research grant support from Abbott; consulting income from Abbott
GWS: consulting fees from Neovasc, Valfix, Gore; equity/options/consulting fees from Ancora; Institutional conflict: Columbia University receives royalties from Abbott for sale of the MitraClip.
NJW: Associate director of an academic echocardiographic core lab (MedStar Health Research Institute) with Institutional contracts with Abbott, Neovasc, Ancora, Mitralign, Medtronic, Boston Scientific, Edwards Lifesciences, Biotronik, Livanova.
The other authors report no conflicts.
Trial Registration (clinicaltrials.gov): NCT 01626079
- Received September 15, 2019.
- Accepted September 17, 2019.
- 2019 The Authors