Causes and Clinical Outcomes of Patients Who Are Ineligible for Transcatheter Mitral Valve Replacement.
Aged
Aged, 80 and over
Cardiac Catheterization
/ adverse effects
Clinical Decision-Making
Disease Progression
Eligibility Determination
Female
Health Status
Heart Valve Prosthesis Implantation
/ adverse effects
Humans
Male
Mitral Valve
/ diagnostic imaging
Mitral Valve Insufficiency
/ diagnostic imaging
Patient Selection
Risk Assessment
Risk Factors
Severity of Illness Index
mitral regurgitation
mitral surgery
transcatheter mitral repair
transcatheter mitral valve replacement
Journal
JACC. Cardiovascular interventions
ISSN: 1876-7605
Titre abrégé: JACC Cardiovasc Interv
Pays: United States
ID NLM: 101467004
Informations de publication
Date de publication:
28 01 2019
28 01 2019
Historique:
received:
02
08
2018
revised:
02
10
2018
accepted:
23
10
2018
entrez:
26
1
2019
pubmed:
27
1
2019
medline:
19
12
2019
Statut:
ppublish
Résumé
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). 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. 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. 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. 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.
Sections du résumé
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.
Identifiants
pubmed: 30678799
pii: S1936-8798(18)32210-6
doi: 10.1016/j.jcin.2018.10.042
pii:
doi:
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
196-204Commentaires et corrections
Type : CommentIn
Informations de copyright
Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.