Transcatheter therapies in patients with mitral regurgitation or poor left ventricular function
Real-world European experience with the transcatheter treatment of significant mitral regurgitation: demographics and procedural outcomes
Aims: Use of the MitraClip System as a transcatheter therapeutic option for treating significant mitral regurgitation (MR) continues to expand throughout Europe. As of June 15, 2012, a total of 4,534 patients have been treated with the MitraClip devices in Europe in a real-world setting in both the ACCESS-EUROPE studies and in commercial use.
Methods and results: Baseline demographics, device time and post-procedural reduction in MR severity are reported from patients treated between September 17, 2008 and June 15, 2012. A total of 4,534 patients were treated at 144 institutions in 17 European countries. Patients were elderly, with a median age of 75 years. At baseline, 67% of patients had functional MR (FMR). Left ventricular (LV) dysfunction was categorised as severe in 34% of patients, with LV ejection fraction <30% reported in 30% of patients. Pre-procedural MR severity was reported as MR ≥3+ in 99.6% of patients. The MitraClip device implant rate was 95.6% with the following distribution of devices: 201 patients (4.4%) underwent the procedure but received no device, 2,873 patients (63.4%) received one device, 1,350 patients (29.8%) received two devices and 110 patients (2.4%) received three or more devices. The median device time was 80 minutes. Post-procedural MR severity was reported as MR ≤2+ in 90% of patients, with 58% of all patients achieving MR ≤1+. Approximately 93% of patients achieved at least a 1-grade reduction in MR severity. No change in MR severity was reported in 5.6% of patients and <1% of patients had worsening MR severity.
Conclusions: As reported, patients treated with the MitraClip device in the real-world use setting are elderly and present with a significant incidence of FMR and impaired LV function. Reduction of MR severity was achieved via the MitraClip therapy in the majority of these patients, demonstrating adoption of the MitraClip therapy in a predominantly high-surgical-risk patient population.
