Guilherme F Attizzani1, Yohei Ohno2, Davide Capodanno3, Stefano Cannata4, Fabio Dipasqua4, Sebastiano Immé4, Sarah Mangiafico4, Marco Barbanti4, Margherita Ministeri4, Anna Cageggi4, Anna Maria Pistritto4, Sandra Giaquinta4, Silvia Farruggio4, Marta Chiarandà4, Giuseppe Ronsivalle4, Audrey Schnell5, Salvatore Scandura4, Corrado Tamburino3, Piera Capranzano4, Carmelo Grasso6. 1. Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy; Harrington Heart and Vascular Institute, University Hospitals, Case Medical Center, Cleveland, Ohio; Interventional Cardiology Department, Pitangueiras Hospital, Jundiai, São Paulo, Brazil. 2. Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy; Department of Cardiology, Tokai University School of Medicine, Isehara, Japan. 3. Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy; Department of Cardiology, Tokai University School of Medicine, Isehara, Japan; Excellence Through Newest Advances (ETNA) Foundation, Catania, Italy. 4. Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy. 5. Harrington Heart and Vascular Institute, University Hospitals, Case Medical Center, Cleveland, Ohio. 6. Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy. Electronic address: melfat75@gmail.com.
Abstract
OBJECTIVES: This study sought to compare, in high-risk patients with 3+ to 4+ mitral regurgitation (MR) dichotomized by baseline echocardiographic features, acute, 30-day, and 12-month outcomes following percutaneous mitral valve repair using the MitraClip. BACKGROUND: The feasibility and mid-term outcomes after MitraClip implantation in patients with echocardiographic features different from the EVEREST (Endovascular Valve Edge-to-Edge Repair) I and II trials have been scarcely studied. METHODS: Clinical and echocardiographic outcomes through 12-month follow-up of consecutive patients who underwent MitraClip implantation were obtained from an ongoing prospective registry. Two different groups, divided according to baseline echocardiographic criteria (investigational group [EVERESTOFF] and control group [EVERESTON]), were compared. RESULTS: Seventy-eight patients were included in EVERESTOFF and 93 patients in EVERESTON groups. Important and comparable acute reductions in MR and no clip-related complications were revealed. The primary safety endpoint at 30 days was comparable between groups (2.6% vs. 6.5%, respectively, p = 0.204); in addition, MR reduction was mostly sustained, whereas equivalent improvement in New York Heart Association functional class were demonstrated. Kaplan-Meier freedom from death, surgery for mitral valve dysfunction, or grade ≥3+ MR at 12 months was demonstrated in 71.4% and 76.2%, respectively, in the EVERESTOFF and EVERESTON groups (log rank p = 0.378). Significant improvements in ejection fraction and reduction in left ventricle volumes were demonstrated in both groups over time, but the baseline between-group differences were sustained. CONCLUSIONS: MitraClip implantation in patients with expanded baseline echocardiographic features, compared with the control group, was associated with similar rates of safety and efficacy through 12-month follow-up. Further validation of our findings is warranted.
OBJECTIVES: This study sought to compare, in high-risk patients with 3+ to 4+ mitral regurgitation (MR) dichotomized by baseline echocardiographic features, acute, 30-day, and 12-month outcomes following percutaneous mitral valve repair using the MitraClip. BACKGROUND: The feasibility and mid-term outcomes after MitraClip implantation in patients with echocardiographic features different from the EVEREST (Endovascular Valve Edge-to-Edge Repair) I and II trials have been scarcely studied. METHODS: Clinical and echocardiographic outcomes through 12-month follow-up of consecutive patients who underwent MitraClip implantation were obtained from an ongoing prospective registry. Two different groups, divided according to baseline echocardiographic criteria (investigational group [EVERESTOFF] and control group [EVERESTON]), were compared. RESULTS: Seventy-eight patients were included in EVERESTOFF and 93 patients in EVERESTON groups. Important and comparable acute reductions in MR and no clip-related complications were revealed. The primary safety endpoint at 30 days was comparable between groups (2.6% vs. 6.5%, respectively, p = 0.204); in addition, MR reduction was mostly sustained, whereas equivalent improvement in New York Heart Association functional class were demonstrated. Kaplan-Meier freedom from death, surgery for mitral valve dysfunction, or grade ≥3+ MR at 12 months was demonstrated in 71.4% and 76.2%, respectively, in the EVERESTOFF and EVERESTON groups (log rank p = 0.378). Significant improvements in ejection fraction and reduction in left ventricle volumes were demonstrated in both groups over time, but the baseline between-group differences were sustained. CONCLUSIONS: MitraClip implantation in patients with expanded baseline echocardiographic features, compared with the control group, was associated with similar rates of safety and efficacy through 12-month follow-up. Further validation of our findings is warranted.
Authors: Dariusz Dudek; Waldemar Banasiak; Wojciech Braksator; Jacek Dubiel; Tomasz Grodzicki; Piotr Hoffman; Mariusz Kuśmierczyk; Grzegorz Opolski; Piotr Ponikowski; Jacek Różański; Jerzy Sadowski; Wojciech Wojakowski; Marcin Grabowski; Katarzyna Bondaryk; Jacek Walczak; Izabela Pieniążek; Maciej Grys; Anna Lesiak-Bednarek; Piotr Przygodzki Journal: Cardiol J Date: 2019-02-14 Impact factor: 2.737
Authors: Steffen D Kriechbaum; Niklas F Boeder; Luise Gaede; Martin Arnold; Ursula Vigelius-Rauch; Peter Roth; Michael Sander; Andreas Böning; Matthias Bayer; Albrecht Elsässer; Helge Möllmann; Christian W Hamm; Holger M Nef Journal: Clin Res Cardiol Date: 2019-08-26 Impact factor: 5.460