Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Safety and Efficacy in Mitral Regurgitation Management with the MitraClip® G4 System: Insights from a Single-Center Study

Version 1 : Received: 13 September 2024 / Approved: 13 September 2024 / Online: 13 September 2024 (16:17:56 CEST)

How to cite: Papadopoulos, G. E.; Ninios, I.; Evangelou, S.; Ioannidis, A.; Ninios, V. Safety and Efficacy in Mitral Regurgitation Management with the MitraClip® G4 System: Insights from a Single-Center Study. Preprints 2024, 2024091101. https://doi.org/10.20944/preprints202409.1101.v1 Papadopoulos, G. E.; Ninios, I.; Evangelou, S.; Ioannidis, A.; Ninios, V. Safety and Efficacy in Mitral Regurgitation Management with the MitraClip® G4 System: Insights from a Single-Center Study. Preprints 2024, 2024091101. https://doi.org/10.20944/preprints202409.1101.v1

Abstract

Background: Mitral regurgitation (MR) is a common valvular disorder linked to high morbidity and mortality. For patients unsuitable for surgery, transcatheter mitral edge-to-edge repair (TEER) with the MitraClip® G4 system offers an alternative. This study aims to evaluate procedural, echocardiographic, functional, and quality of life (QoL) outcomes in patients who underwent TEER with the MitraClip® G4 system, along with possible predictors of New York Heart Associa-tion (NYHA) class I at 30 days and 1 year. Methods: Patients with moderate-to-severe (3+) or se-vere (4+) degenerative MR (DMR) or functional MR (FMR), classified as NYHA class III or IV, who underwent TEER with the MitraClip® G4 system at our center between January 2021 and De-cember 2023 were included. Results: A total of 83 patients [71% FMR, 66% male, median (IQR) age 70 (11) years] underwent TEER, with 100% procedural success. MR ≤2+ was achieved in 100% and 98% of patients at 30 days and 1 year, respectively. NYHA class I or II was achieved in 100% and 96.8% of patients at 30 days and 1 year, respectively. The Kansas City Cardiomyopathy Ques-tionnaire (KCCQ) score improved from 51±20 at baseline to 69±15 at 30 days (p< 0.001) and 70.5±15 at 1 year (p< 0.001). Lower baseline N-terminal pro-brain natriuretic peptide (NT-proBNP) pre-dicted achieving NYHA class I at 30 days (HR: 0.63, 95% CI: 0.41–0.95, p = 0.030), while lower Eu-ropean System for Cardiac Operative Risk Evaluation II (EuroSCORE II) and NT-proBNP pre-dicted it at 1 year [(HR: 0.50, 95% CI: 0.28–0.89, p = 0.019), (HR: 0.67, 95% CI: 0.44–0.99, p = 0.049), respectively]. Conclusions: The MitraClip® G4 system provides significant improvements in MR severity, functional class, and QoL. Lower NT-proBNP and EuroSCORE II were strong predictors of achieving optimal functional status (NYHA class I).

Keywords

mitral regurgitation; transcatheter edge-to-edge repair; MitraClip; MR severity; QoL; NYHA class

Subject

Medicine and Pharmacology, Cardiac and Cardiovascular Systems

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