# Outcome Improvement with Last-Generation Devices in Mitral Transcatheter Edge-to-Edge Repair: Insights from the Real-World MitraClip Florence Registry

## TL;DR

Newer MitraClip devices improve outcomes for patients with severe heart valve issues, showing faster procedures and better survival rates.

## Contribution

Demonstrates real-world effectiveness and safety improvements of the latest MitraClip device compared to earlier models.

## Key findings

- Procedural success was high (97%) across groups, with significantly better MR reduction in the G4 group.
- Time to device deployment was significantly shorter with the G4 system.
- The G4 group showed better 5-year survival rates compared to earlier device groups.

## Abstract

Background/Objectives: Over the past two decades, MitraClip™ therapy has proven to be an effective and safe treatment for severe mitral regurgitation (MR), with more than 200,000 patients treated globally through continuous advancements in device design and implantation techniques. This retrospective, observational, single-center study aimed to assess the safety and efficacy of the latest generation of MitraClip compared to earlier models in the Real-World MitraClip Florence Registry. The primary efficacy endpoint was a comparison in terms of the rate of successful procedures, the time to device deployment and the duration of the hospital stay. The secondary safety endpoint regarded long-term all-cause mortality and hospitalization for heart failure. Methods: Patients treated at our center from January 2016 to June 2022 were included. They were divided into two groups: those receiving early-generation devices (G1–G3) and those treated with the last-generation device (G4). All patients underwent a comprehensive preoperative echocardiographic assessment, with a re-evaluation before hospital discharge and after 12 months. A long-term follow-up focusing on all-cause mortality and hospitalization for heart failure was conducted. Results: Of 131 patients, 81 received the last-generation device. The mean age was 79.4 years. Both groups exhibited a high burden of comorbidities (overall mean n = 2.85). Procedural success was high (97%) across groups, with a significantly better MR reduction (Grade ≤ 1) in the G4 group (47% vs. 70%, p = 0.009). The time to device deployment was significantly shorter with the G4 system (72 vs. 135 min, p < 0.001), and there was a trend towards shorter hospital stays (6.1 vs. 7.9 days, p = 0.08). Kaplan–Meier analysis demonstrated better 5-year survival rates for the last-generation device group (p = 0.019), with no significant difference in rehospitalization rates (p = 0.186). Conclusions: The MitraClip G4 system in the real world for the treatment of severe MR is safe and effective, achieving immediate and durable procedural success, accompanied by an improved NYHA functional class. Moreover, a better long-term survival rate was observed, along with a comparable high rate of recurrent HF hospitalization, reflecting a high comorbidity burden in this frail population.