HighLife TMVR induces significant annular and concomitant ventricular remodeling

L. Schneider (Ulm)¹, M. Paukovitsch (Ulm)¹, J. K. Scheffler (Ulm)¹, D. Felbel (Ulm)¹, M. Keßler (Ulm)¹, S. Braun (Ulm)², M. Nasr³, S. Brecker³, J. Montarello (Adelaide)⁴, D. W. Muller (Sydney)⁵, A. Witkowski (Warschau)⁶, W. Wojakowski (Katovice)⁷, T. Walton (Richmond)⁸, Z. Huczek (Warsaw)⁹, A. Camuglia (Brisbane)¹⁰, W. Yeow (Perth)¹¹, W. Rottbauer (Ulm)^1
1Universitätsklinikum Ulm Klinik für Innere Medizin II Ulm, Deutschland; ²Universitäres Herzzentrum Innere Medizin II Ulm, Deutschland; ³Deutschland; ⁴Royal Adelaide Hospital St Andrew´s Hospital Adelaide, Australien; ⁵St. Vincent's Hospital Sydney, Australien; ⁶Instytut Kardiologii i Angiologii Interwencyjnej Warschau, Polen; ⁷Medical University of Silesia Department of Cardiology and Structural Heart Diseases Katovice, Polen; ⁸Epworth Hospital Richmond, Australien; ⁹Medical University of Warsaw Warsaw, Polen; ¹⁰University of Queensland Brisbane, Australien; ¹¹Genesis Care Mount Hospital Perth, Australien

Background:

Transcatheter mitral valve replacement (TMVR) using the HighLife TMVR system has demonstrated feasibility, acceptable safety, correction of mitral regurgitation and functional improvement in symptomatic patients. Additionally, echocardiographic assessment of a larger single-center patient cohort has shown significant annuloplasty due to the undersizing docking mechanism of the 2-component technique. The aim of this investigation was to confirm annular and to assess potential ventricular remodeling after HighLife implantation using CT imaging of a multi-center patient cohort.

Methods:

Pre- and postprocedural CT studies of 21 patients treated at 9 centers within the HighLife (HL2018-01-TS) and HighFLO (HL201-01) clinical trials were assessed regarding the largest annular diameters in anterior-posterior (A-P), anteromedial-posterolateral (AM-PL) and septal-lateral (S-L) planes as well as the total annular perimeter (tAP) during diastole. Moreover, measurements of left ventricular end-diastolic and end-systolic dimensions before and after valve implantation were compared and related to annular remodeling.

Results:

Before valve implantation, native mitral annuli of the investigated patients showed mean tAP of 142.6±11.4mm, A-P diameters of 43.3±4.5mm, AM-PL diameters of 42.8±3.6mm and S-L diameters of 44.3±3.4mm. After successful TMVR, mean tAP, A-P, AM-PL and S-L diameters decreased to 133.9±9.3mm, 41.0±2.9mm, 40.2±3.0mm and 39.7±3.2mm, respectively. Overall, TMVR resulted in significant annular remodeling with pronounced effects on S-L dimensions (tAP: -6.0±4.2%, A-P: -5.0±5.7%, AM-PL: -5.8±4.7%, S-L: -10.2±5.0%; p<0.01 respectively). Eventually, pre- and postprocedural assessment of left ventricular end-diastolic and end-systolic dimensions in typical three chamber (LVEDD and LVESD) as well as intercommissural (ICEDD and ICESD) views demonstrated concomitant ventricular remodeling (LVEDD pre/post: 57.3±6.8/52.5± 6.1mm, -11.6±5.0%, p<0.01; LVESD pre/post: 47.6±9.9/45.0±9.2mm, -4.6±11.1, p=0.13; ICEDD pre/post: 63.8±6.8/57.2±7.0mm, -12.5±9.8%, p<0.01; ICESD pre/post: 52.4±8.5/48.2±10.1mm, -8.4±11.2%, p=0.02).

Conclusion:

Pre- and postprocedural CT measurements of annular and ventricular dimensions of a small multi-center patients cohort treated within the HighLife and HighFLO clinical trials showed significant annuloplasty and concomitant ventricular remodeling. A larger cohort should be assessed and correlated with outcome.