Efficacy and evolution of edge-to-edge transcatheter valve repair procedures

Abstract

Abstract Background Edge-to-edge transcatheter mitral valve repair (M-TEER) has shown safety and efficacy in reducing secondary mitral regurgitation (MR) (1,2) and led to the development of similar devices for transcatheter valve repair (T-TEER) for tricuspid regurgitation (TR) (Fig. 1A). However, T-TEER implementation is challenging due to complex valve anatomy and periprocedural imaging. We sought to understand to which extent procedural success of M-TEER changed over time and possibly impacted T-TEER results. Methods We retrospectively analyzed intraprocedural reduction of secondary MR and TR after release of a valve specific device, between 2018, when M-TEER was implemented in our center, through 2020, when T-TEER procedures started, and up to the end of 2022. We compared results between the 55 T-TEER procedures performed (age 81.8±4.7, 55% females) and 3 M-TEER cohorts: the very first 55 M-TEER, the last 55 M-TEER before T-TEER, and the very last 55 M-TEER (overall mean-age 78.4±8.2, 49% females) (Fig. 1B). Severe MR III/IV was defined by an effective regurgitation orifice area (EROA) of 20-39mm², and IV/IV by EROA ≥40mm², while TR was evaluated using the I/V to V/V classification. Considering that a 5-grade reduction of TR is either not possible or not desirable, the extension of regurgitation reduction for both valves was set on a scale from 1- to 4-grade. Also, optimal results were defined as residual MR 0+ (none or trace) or TR I+ (mild or mild to moderate), while acceptable results were considered MR I+ and TR II+ (moderate or moderate to severe). Results In all groups, regurgitation was successfully and significantly reduced within-group (Fig. 1C). MR reduction to optimal or acceptable levels increased over time from 60% at the start of the M-TEER program to 78% after 12-18 months (p=0.039), and 84% (p=0.005) after approximately 3 years. Accordingly, the extent of regurgitation reduction significantly improved between the first 2 M-TEER cohorts (p=0.016), as well as the first and the last 55 M-TEER (p=0.045), with no significant change from the second to the third population (p=0.267) (Fig. 2). Two years after the first M-TEER, T-TEER with valve specific devices was implemented and achieved 84% optimal or acceptable residual TR, better than initial M-TEER (p=0.005) and similar to the second (p=0.466) and third M-TEER cohorts (p=1.000). In terms of extent of regurgitation reduction, T-TEER also performed similar to the very first (p=0.645) and the very last M-TEER procedures (p=0.076), despite higher mean-EROA (78.5±32.2mm² vs 44.8±16.1mm² in all MR patients, p<0.001), more complex anatomy, more challenging imaging, and sicker patients (mean-EuroSCORE II 8.8±6.6% vs 6.4±5.3% in all MR patients, p<0.001). Conclusions In our center, gain in knowledge and experience, coupled with technological advances, have significantly impacted procedural M-TEER success over time and allowed similar successful implementation of a T-TEER program.Figure 1Figure 2