Anatomic suitability for transapical transcatheter mitral valve implantation using a tether-based device

TY - JOUR

T1 - Anatomic suitability for transapical transcatheter mitral valve implantation using a tether-based device

AU - Blanke, Philipp

AU - Modine, Thomas

AU - Duncan, Alison

AU - Taramasso, Maurizio

AU - Dumonteil, Nicolas

AU - Chuang, Michael L

AU - Conradi, Lenard

N1 - © 2023 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

PY - 2023/8

Y1 - 2023/8

N2 - BACKGROUND: Transcatheter mitral valve implantation (TMVI) is a novel therapeutic option for treating symptomatic mitral valve disease. Evaluating patient anatomical suitability is a critical step in the TMVI screening process, but currently requires specialized software and computerized device models.AIMS: This analysis sought to assess the effectiveness of simple and standardized multislice computed tomography (MSCT) anatomic measurements for their ability to discriminate between patients who passed anatomical screening for Tendyne™ TMVI.METHODS: Subjects screened for the Tendyne Expanded Clinical Study from January 2016 through September 2019 were included. Core laboratory screening measurements included mitral annular (MA) dimensions at end-systole and end-diastole, simulated device implantation, and neo-left ventricular outflow tract (LVOT) area. Additionally, nine standard measurements of patient anatomy were assessed for their predictive value of patients passing the anatomic screening process.RESULTS: Out of 496 subjects screened for eligibility, 257 subjects met clinical eligibility criteria with MA dimensions within the manufacturer's suggested range: 153 (59.5%) underwent TMVI while 104 (40.5%) were excluded from the study for other anatomic reasons (76% due to risk of LVOT obstruction). CT-derived left ventricular end-systole diameter (LVESD) had the highest discriminatory power for predicting TMVI anatomical suitability (area under the curve of 0.908, p < 0.0001). The mitral inter-commissural (IC) dimension was best predictive of annular dimensions being within range, with dimensions <30 or >50 mm resulting in a negative predictive value of 94.4%.CONCLUSIONS: MSCT-derived mitral IC dimension and LVESD easily performed measures that are effective predictors of anatomical suitability or screen failure for this tether-based TMVI device.

AB - BACKGROUND: Transcatheter mitral valve implantation (TMVI) is a novel therapeutic option for treating symptomatic mitral valve disease. Evaluating patient anatomical suitability is a critical step in the TMVI screening process, but currently requires specialized software and computerized device models.AIMS: This analysis sought to assess the effectiveness of simple and standardized multislice computed tomography (MSCT) anatomic measurements for their ability to discriminate between patients who passed anatomical screening for Tendyne™ TMVI.METHODS: Subjects screened for the Tendyne Expanded Clinical Study from January 2016 through September 2019 were included. Core laboratory screening measurements included mitral annular (MA) dimensions at end-systole and end-diastole, simulated device implantation, and neo-left ventricular outflow tract (LVOT) area. Additionally, nine standard measurements of patient anatomy were assessed for their predictive value of patients passing the anatomic screening process.RESULTS: Out of 496 subjects screened for eligibility, 257 subjects met clinical eligibility criteria with MA dimensions within the manufacturer's suggested range: 153 (59.5%) underwent TMVI while 104 (40.5%) were excluded from the study for other anatomic reasons (76% due to risk of LVOT obstruction). CT-derived left ventricular end-systole diameter (LVESD) had the highest discriminatory power for predicting TMVI anatomical suitability (area under the curve of 0.908, p < 0.0001). The mitral inter-commissural (IC) dimension was best predictive of annular dimensions being within range, with dimensions <30 or >50 mm resulting in a negative predictive value of 94.4%.CONCLUSIONS: MSCT-derived mitral IC dimension and LVESD easily performed measures that are effective predictors of anatomical suitability or screen failure for this tether-based TMVI device.

KW - Humans

KW - Mitral Valve/diagnostic imaging

KW - Mitral Valve Insufficiency/diagnostic imaging

KW - Heart Valve Prosthesis Implantation

KW - Cardiac Catheterization

KW - Treatment Outcome

KW - Heart Valve Prosthesis

U2 - 10.1002/ccd.30752

DO - 10.1002/ccd.30752

M3 - SCORING: Journal article

C2 - 37354444

VL - 102

SP - 318

EP - 327

JO - CATHETER CARDIO INTE

JF - CATHETER CARDIO INTE

SN - 1522-1946

IS - 2

ER -