PASCAL versus MitraClip-XTR edge-to-edge device for the treatment of tricuspid regurgitation: a propensity-matched analy

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ORIGINAL PAPER

PASCAL versus MitraClip‑XTR edge‑to‑edge device for the treatment of tricuspid regurgitation: a propensity‑matched analysis Atsushi Sugiura1   · Johanna Vogelhuber1 · Can Öztürk1 · Zita Schwaibold1 · David Reckers1 · Tadahiro Goto2 · Refik Kavsur1 · Marc Ulrich Becher1 · Sebastian Zimmer1 · Georg Nickenig1 · Marcel Weber1 Received: 5 August 2020 / Accepted: 19 November 2020 © The Author(s) 2020

Abstract Background  Transcatheter tricuspid valve repair (TTVR) is a promising technique for the treatment of tricuspid regurgitation (TR). Data comparing the performance of novel edge-to-edge devices (PASCAL and MitraClip-XTR) are scarce. Methods  We identified 80 consecutive patients who underwent TTVR using either the PASCAL or MitraClip-XTR system to treat symptomatic TR from July 2018 to June 2020. To adjust for baseline imbalances, we performed a propensity score (PS) 1:1 matching. The primary endpoint was a reduction in TR severity by at least one grade at 30 days. Results  The PS-matched cohort (n = 44) was at high-surgical risk (EuroSCORE II: 7.5% [interquartile range (IQR) 4.8– 12.1%]) with a mean TR grade of 4.3 ± 0.8 and median coaptation gap of 6.2 mm [IQR 3.2–9.1 mm]. The primary endpoint was similarly observed in both groups (PASCAL: 91% vs. MitraClip-XTR: 96%). Multiple device implantation was the most common form (59% vs. 82%, p = 0.19), and the occurrence of SLDA was comparable between the PASCAL and MitraClipXTR system (5.7% [2 of 35 implanted devices] vs. 4.4% [2 of 45 implanted devices], p = 0.99). No periprocedural death or conversions to surgery occurred, and 30-day mortality (5.0% vs. 5.0%, log-rank p = 0.99) and 3-month mortality (10.0% vs. 5.0%, log-rank p = 0.56) were similar between both groups. During follow-up, functional NYHA class, 6-min walking distance, and health status improved in both groups. Conclusions  Both TTVR devices, PASCAL and MitraClip-XTR, appeared feasible and comparable for an effective TR reduction. Randomized head-to-head comparisons will help to further define the appropriate scope of application of each system. Keywords  Transcathether · Edge-to-edge · Tricuspid regurgitation · MitraClip · PASCAL · Propensity score matching

Background

Atsushi Sugiura, Johanna Vogelhuber have contributed equally to this paper. Supplementary Information  The online version contains supplementary material available at https​://doi.org/10.1007/s0039​ 2-020-01784​-w. * Atsushi Sugiura [email protected] 1



Herzzentrum Bonn, Medizinische Klinik und Poliklinik II, Universitätsklinikum Bonn, Venusberg‑Campus 1, 53127 Bonn, Germany



Department of Clinical Epidemiology and Health Economics, School of Public Health, University of Tokyo, TXP Medical Co. Ltd., Tokyo, Japan

2

Tricuspid regurgitation (TR) is no longer called “a forgotten valvular disease.” Instead, TR has turned out as a prognostic devastator. Previous cohort studies demonstrated a clear association between significant TR and excess mortality and reduced quality of life (QOL) [1, 2]. Due to the high-sur