000			04554nam a22007097a 4500
008			240807s20242024 xxu||||| |||| 00| 0 eng d
022			_a1774-024X
024			_aEIJ-D-23-00904 [pii]
024			_aPMC11228541 [pmc]
040			_aOvid MEDLINE(R)
099			_a39007829
245			_aClinical outcomes and predictors of transapical transcatheter mitral valve replacement: the Tendyne Expanded Clinical Study.
251			_aEurointervention. 20(14):e887-e897, 2024 Jul 15.
252			_aEuroIntervention. 20(14):e887-e897, 2024 Jul 15.
253			_aEuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
260			_c2024
260			_fFY2025
260			_p2024 Jul 15
265			_sepublish
265			_tMEDLINE
266			_d2024-08-07
266			_z2024/07/15 10:33
520			_aAIMS: This study aimed to investigate the outcomes and predictors of mortality for patients treated with transapical TMVR.
520			_aBACKGROUND: 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.
520			_aCONCLUSIONS: 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.
520			_aMETHODS: 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.
520			_aRESULTS: 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).
546			_aEnglish
650			_a*Cardiac Catheterization
650			_a*Heart Valve Prosthesis Implantation
650			_a*Mitral Valve
650			_a*Mitral Valve Insufficiency
650			_aAged
650			_aAged, 80 and over
650			_aCardiac Catheterization/ae [Adverse Effects]
650			_aCardiac Catheterization/is [Instrumentation]
650			_aCardiac Catheterization/mt [Methods]
650			_aFemale
650			_aHeart Valve Prosthesis
650			_aHeart Valve Prosthesis Implantation/ae [Adverse Effects]
650			_aHeart Valve Prosthesis Implantation/is [Instrumentation]
650			_aHeart Valve Prosthesis Implantation/mt [Methods]
650			_aHumans
650			_aMale
650			_aMiddle Aged
650			_aMitral Valve Insufficiency/dg [Diagnostic Imaging]
650			_aMitral Valve Insufficiency/mo [Mortality]
650			_aMitral Valve Insufficiency/pp [Physiopathology]
650			_aMitral Valve Insufficiency/su [Surgery]
650			_aMitral Valve/dg [Diagnostic Imaging]
650			_aMitral Valve/pp [Physiopathology]
650			_aMitral Valve/su [Surgery]
650			_aRisk Factors
650			_aTreatment Outcome
650			_zAutomated
651			_aMedStar Union Memorial Hospital
657			_aJournal Article
700			_aBethea, Brian _bMUMH
790			_aConradi L, Ludwig S, Sorajja P, Duncan A, Bethea B, Dahle G, Babaliaros V, Guerrero M, Thourani V, Dumonteil N, Modine T, Garatti A, Denti P, Leipsic J, Chuang ML, Blanke P, Muller DW, Badhwar V
856			_uhttps://dx.doi.org/10.4244/EIJ-D-23-00904 _zhttps://dx.doi.org/10.4244/EIJ-D-23-00904
942			_cART _dArticle
999			_c14532 _d14532