Anatomic suitability for transapical transcatheter mitral valve implantation using a tether-based device.
LVOT obstruction
mitral regurgitation
multislice computed tomography
transapical transcatheter mitral valve implantation
Journal
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
ISSN: 1522-726X
Titre abrégé: Catheter Cardiovasc Interv
Pays: United States
ID NLM: 100884139
Informations de publication
Date de publication:
08 2023
08 2023
Historique:
revised:
17
05
2023
received:
20
12
2022
accepted:
11
06
2023
medline:
7
8
2023
pubmed:
24
6
2023
entrez:
24
6
2023
Statut:
ppublish
Résumé
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. 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. 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. 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%. 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.
Sections du résumé
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.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
318-327Informations de copyright
© 2023 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.
Références
Muller DWM, Farivar RS, Jansz P, et al. Transcatheter mitral valve replacement for patients with symptomatic mitral regurgitation. J Am Coll Cardiol. 2017;69:381-391.
Bapat V, Rajagopal V, Meduri C, et al. Early experience with new transcatheter mitral valve replacement. J Am Coll Cardiol. 2017;71:12-21.
Sorajja P, Moat N, Badhwar V, et al. Initial feasibility study of a new transcatheter mitral prosthesis. J Am Coll Cardiol. 2019;73:1250-1260.
Blanke P, Naoum C, Dvir D, et al. Predicting LVOT obstruction in transcatheter mitral valve implantation. JACC Cardiovasc Imaging. 2017;10:482-485.
Meduri CU, Reardon MJ, Lim DS, et al. Novel multiphase assessment for predicting left ventricular outflow tract obstruction before transcatheter mitral valve replacement. JACC Cardiovasc Interv. 2019;12:2402-2412.
Weir-McCall JR, Blanke P, Naoum C, Delgado V, Bax JJ, Leipsic J. Mitral valve imaging with CT: relationship with transcatheter mitral valve interventions. Radiology. 2018;288:638-655.
Muller DWM, Farivar RS, Jansz P, et al. Transcatheter mitral valve replacement for patients with symptomatic mitral regurgitation. J Am Coll Cardiol. 2017;69:381-391.
Blanke P, Dvir D, Cheung A, et al. A simplified D-shaped model of the mitral annulus to facilitate CT-based sizing before transcatheter mitral valve implantation. J Cardiovasc Comput Tomogr. 2014;8:459-467.
Zoghbi WA, Adams D, Bonow RO, et al. Recommendations for noninvasive evaluation of native valvular regurgitation. J Am Soc Echocardiogr. 2017;30:303-371.
Blanke P, Naoum C, Webb J, et al. Multimodality imaging in the context of transcatheter mitral valve replacement establishing consensus among modalities and disciplines. JACC Cardiovasc Imaging. 2015;8:1192-1208.