Author + information
- Received August 2, 2018
- Revision received October 2, 2018
- Accepted October 23, 2018
- Published online January 21, 2019.
- Hiroki Niikura, MD,
- Mario Gössl, MD, PhD,
- Vibhu Kshettry, MD,
- Sara Olson, BSN, RN,
- Benjamin Sun, MD,
- Judah Askew, MD,
- Larissa Stanberry, PhD,
- Ross Garberich, MS,
- Liang Tang, MD,
- John Lesser, MD,
- Richard Bae, MD,
- Kevin M. Harris, MD,
- Steven M. Bradley, MD, MPH and
- Paul Sorajja, MD∗ ()
- Valve Science Center, Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, Minneapolis, Minnesota
- ↵∗Address for correspondence:
Dr. Paul Sorajja, Valve Science Center, Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, Minneapolis, Minnesota 55407.
Objectives The aim of this study was to gain insight into the causes and outcomes of patients who do not qualify for transcatheter mitral valve replacement (TMVR).
Background Despite the increasing availability of TMVR, patients with severe mitral regurgitation may not be eligible. Thus far, no investigation has examined ineligible patients and their clinical outcomes.
Methods A total of 203 patients (mean age 79 ± 9 years, 48% men) who were ineligible for participation in early feasibility studies of TMVR were examined.
Results The ineligibility rate for TMVR was 89.0%. The most common reasons for TMVR exclusion were excessive frailty (15.3%), severe tricuspid regurgitation (15.3%), and prior aortic valve therapy (14.2%). Mitral anatomic exclusions were present in 15.8%, with severe annular calcification in 7.4%, and risk for left ventricular outflow tract obstruction was notably infrequent (4.4%). Overall, 76 patients (37.4%) did not undergo subsequent commercial surgical or transcatheter mitral therapy. Patients not eligible for TMVR and not treated commercially had high rates of cardiac death (11.8%) and death or heart failure hospitalization (22.4%) at 1 year. These rates were significantly higher than those who underwent surgery (2.4% for cardiac death; p < 0.001; 5.5% for heart failure hospitalization; p = 0.003) and remained worse after excluding patients with excessive frailty or medical futility and in multivariate modeling that adjusted for baseline differences.
Conclusions Patients ineligible for TMVR and treated medically have poor outcomes. These data and the high rate of TMVR screen failure support the need for therapy iteration as well as development of alternative means of management, with the goal of improving the prognosis of these patients.
Dr. Sun is a consultant for Abbott Vascular. Dr. Bae is a speaker for Abbott Vascular. Dr. Sorajja has received research grants and consulting and speaking fees from Edwards Lifesciences, Boston Scientific, Medtronic, and Abbott Vascular. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received August 2, 2018.
- Revision received October 2, 2018.
- Accepted October 23, 2018.
- 2019 American College of Cardiology Foundation
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