TY  - BOOK
AU  - Bethea, Brian
TI  - Clinical outcomes and predictors of transapical transcatheter mitral valve replacement: the Tendyne Expanded Clinical Study
SN  - 1774-024X
PY  - 2024///
KW  - *Cardiac Catheterization
KW  - *Heart Valve Prosthesis Implantation
KW  - *Mitral Valve
KW  - *Mitral Valve Insufficiency
KW  - Aged
KW  - Aged, 80 and over
KW  - Cardiac Catheterization/ae [Adverse Effects]
KW  - Cardiac Catheterization/is [Instrumentation]
KW  - Cardiac Catheterization/mt [Methods]
KW  - Female
KW  - Heart Valve Prosthesis
KW  - Heart Valve Prosthesis Implantation/ae [Adverse Effects]
KW  - Heart Valve Prosthesis Implantation/is [Instrumentation]
KW  - Heart Valve Prosthesis Implantation/mt [Methods]
KW  - Humans
KW  - Male
KW  - Middle Aged
KW  - Mitral Valve Insufficiency/dg [Diagnostic Imaging]
KW  - Mitral Valve Insufficiency/mo [Mortality]
KW  - Mitral Valve Insufficiency/pp [Physiopathology]
KW  - Mitral Valve Insufficiency/su [Surgery]
KW  - Mitral Valve/dg [Diagnostic Imaging]
KW  - Mitral Valve/pp [Physiopathology]
KW  - Mitral Valve/su [Surgery]
KW  - Risk Factors
KW  - Treatment Outcome
KW  - Automated
KW  - MedStar Union Memorial Hospital
KW  - Journal Article
N2  - AIMS: This study aimed to investigate the outcomes and predictors of mortality for patients treated with transapical TMVR; BACKGROUND: Transcatheter mitral valve replacement (TMVR) is a therapeutic option for patients with severe mitral regurgitation (MR) who are ineligible for conventional surgery. There are limited data on the outcomes of large patient cohorts treated with TMVR; CONCLUSIONS: This study investigated clinical outcomes in the full cohort of patients included in the Tendyne Expanded Clinical Study. The Tendyne TMVR system successfully eliminated MR with no intraprocedural deaths, resulting in an improvement in symptoms and quality of life. Continued refinement of clinical and echocardiographic risks will be important to optimise longitudinal outcomes; METHODS: This analysis represents the clinical experience of all patients enrolled in the Tendyne Expanded Clinical Study. Patients with symptomatic MR underwent transapical TMVR with the Tendyne system between November 2014 and June 2020. Outcomes and adverse events up to 2 years, as well as predictors of short-term mortality, were assessed; RESULTS: A total of 191 patients were treated (74.1+/-8.0 years, 62.8% male, Society of Thoracic Surgeons Predicted Risk of Mortality 7.7+/-6.6%). Technical success was achieved in 96.9% (185/191), and there were no intraprocedural deaths. At 30-day, 1- and 2-year follow-up, the rates of all-cause mortality were 7.9%, 30.8% and 40.5%, respectively. Complete MR elimination (MR <1+) was observed in 99.3%, 99.1% and 96.3% of patients, respectively. TMVR treatment resulted in consistent improvement of New York Heart Association Functional Class and quality of life up to 2 years (both p<0.001). Independent predictors of early mortality were age (odds ratio [OR] 1.11; p=0.003), pulmonary hypertension (OR 3.83; p=0.007), and institutional experience (OR 0.40; p=0.047)
UR  - https://dx.doi.org/10.4244/EIJ-D-23-00904
ER  -