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. 2025 Jun 20;14(13):4412.
doi: 10.3390/jcm14134412.

An Imaging-Based Marker to Refine Risk Stratification for Transcatheter Mitral Valve Replacement

Liliane Zillner  1 , Mirjam G Wild  2 , Michaela M Hell  3 , Harald Herkner  4 , Elmar W Kuhn  5 , Tanja Rudolph  6 , Thomas Walther  7 , Lenard Conradi  8 , Andreas Zierer  9 , Francesco Maisano  10 , Marco Russo  11 , Fabrizio Rosati  12 , Andrea Colli  13 , Miguel Piñón  14 , David Reineke  15 , Gaby Aphram  16 , Tillmann Kerbel  1 , Christophe Dubois  17 , Jörg Hausleiter  2   18 , Ralph Stephan von Bardeleben  3 , Markus Mach  1 , Christian Loewe  19 , Martin Andreas  1
Affiliations

An Imaging-Based Marker to Refine Risk Stratification for Transcatheter Mitral Valve Replacement

Liliane Zillner et al. J Clin Med. .

Abstract

Background: The Tendyne™ transcatheter heart valve (THV) system is a promising option for high-risk patients with severe mitral regurgitation (MR) who are ineligible for surgery or transcatheter edge-to-edge repair (TEER). As most fatal complications occur within the first 90 days, this study aimed to identify anatomical predictors of in-hospital mortality after transcatheter mitral valve replacement (TMVR). Methods: In this subanalysis of the TENDER registry, data from 110 patients who underwent TMVR across 26 centers between January 2020 and June 2022 were evaluated. Preprocedural imaging parameters were analyzed, including transthoracic echocardiography (TTE), transesophageal echocardiography (TEE), and cardiac 4D computed tomography (CT). Results: We identified LVEDDi as a significant predictor of in-hospital mortality (p = 0.022), with lower values in non-survivors (26.42 ± 3.76 mm/m2) than in survivors (30.37 ± 5.58 mm/m2). Both indexed and absolute LVEDDi predicted in-hospital complications (p < 0.001 and p = 0.008). In multivariate analysis, LVEDDi (p = 0.048; OR = 0.856) and STS score (p = 0.038; OR = 1.114) remained independent predictors of in-hospital mortality. In an extended model, only LVEDDi persisted as a significant predictor (p = 0.007), highlighting its robustness. Conclusions: This analysis identified a small LVEDDi as a novel, clinically relevant risk factor in TMVR and showed its added value alongside conventional markers. Its easy calculation supports incorporating LVEDDi thresholds into screening to improve patient selection and outcomes.

Keywords: Tendyne™ valve system; left ventricular end-diastolic diameter index (LVEDDi); transcatheter mitral valve replacement (TMVR).

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Conflict of interest statement

Elmar Kuhn declares conflicts of interest with Abbott (consulting, advisory, proctoring) and Medtronic (consulting, advisory, proctoring). Tillmann Kerbel received speaker honoraria from Abbott. Lenard Conradi reports advisory board membership and consulting activities for Abbott, Medtronic, JenaValve, Edwards Lifesciences, Boston Scientific, MicroPort, PiCardia, VenusMedtech, Neovasc, MicroInterventions, and Smartcanula Sarl. Andreas Zierer serves as a proctor for Abbott (Tendyne) and has received speaker honoraria and educational grants from Abbott. Francesco Maisano reports research and grant support from Abbott, Medtronic, Edwards Lifesciences, Biotronik, Boston Scientific, NVT, Terumo, and VenusMedtech. He also reports personal consulting fees and honoraria from Abbott, Medtronic, Edwards Lifesciences, Xeltis, Cardiovalve, Occlufit, Simulands, Mtex, VenusMedtech, and Squadra. Additionally, he declares royalty income/IP rights from Edwards Lifesciences and equity ownership in Cardiogard, Cardiovalve, Magenta, SwissVortex, Transseptal Solutions, 4Tech, and Perifect. Marco Russo reports research support from Edwards Lifesciences. Andrea Colli is a proctor and consultant for Abbott. David Reineke reports travel support from Abbott, Edwards Lifesciences, and Medtronic and proctoring and consulting contracts with Abbott and Medtronic. Christophe Dubois reports consulting activities with Boston Scientific and Corcym and proctoring for Edwards Lifesciences. Jörg Hausleiter received speaker fees, research support, and advisory fees from Edwards Lifesciences. Ralph Stephan von Bardeleben serves as a speaker and advisor for Abbott Cardiovascular, Edwards Lifesciences, Medtronic, NeoChord, Philips, and Siemens. He also reports unpaid trial activity for Abbott Cardiovascular, Edwards Lifesciences, Jenscare, Medtronic, and NeoChord. Martin Andreas acts as a proctor, consultant, and speaker for Edwards, Abbott, Medtronic, Boston Scientific, Zoll, and Braun and has received institutional research grants from Edwards, Abbott, Medtronic, and LSI. All other authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results.

Figures

Figure 1
Figure 1
Visual Abstract: Indexed LVEDDi predicts Outcome in TMVR. LVEDDi, Left Ventricular End-Diastolic Diameter Index; STS Score: Society of Thoracic Surgeons Score; LV, Left Ventricle; LVEF, Left Ventricular Ejection Fraction; EuroSCORE, European System for Cardiac Operative Risk Evaluation; TMVR; Transcatheter Mitral Valve Replacement. Adapted with permission from Abbott. Created using Canva.
Figure 2
Figure 2
Flow chart indicating the identification of the study population, including the inclusion and exclusion criteria.
Figure 3
Figure 3
Obligatory screening thresholds for THV on MR. AML, Anterior Mitral Leaflet; AP, Anterior–Posterior; CT, Computed Tomography; EF, Ejection Fraction; IC, Intercommissural; IC/3CH, Intercommissural 3 Chamber View; LVEDD, Left Ventricular End-Diastolic Diameter; LVESD, Left Ventricular End-Systolic Dimension; MR, Mitral Regurgitation; NeoLVOT, Neo Left Ventricular Outflow Tract; PLAX, Parasternal Long-Axis; SAX, Short-Axis; TTE, Transthoracic Echocardiography; TEE, Transesophageal Echocardiography; THV, Transcatheter Heart Valve (Abbott Prescreening Guides based on [12,13,14], created unsing Canva).
Figure 4
Figure 4
Natural spline curve: LVEDDi and in-hospital mortality. A natural spline model analyzing the relationship between the LVEDDi and in-hospital mortality, including three knots (26, 34, and 42), with boundary knots at 25 and 75 (adjusted R2 = 0.0257). Blue line: actual observed data representing the probability of in-hospital death; red line: smoothed spline values showing the modeled trend.
See this image and copyright information in PMC

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