Abstract
BACKGROUND: Our aim was to assess safety and efficacy outcomes at 1 year after MitraClip for percutaneous mitral valve repair in patients with severe mitral regurgitation. Twenty consecutive patients with significant MR (GIII or GIV) were selected according to the AHA/ACC guidelines from June 2016 to June 2019 and underwent percutaneous edge-to-edge mitral valve repair using MitraClip with a whole 1 year follow-up following the procedure. The primary acute safety endpoint was a 30-day freedom from any of the major adverse events (MAEs) or rehospitalization for heart failure. The primary efficacy endpoint was acute procedural success defined as clip implant with an improvement of MR to ≤ grade II, based on current guidelines, NYHA class, ejection fraction, and the left atrium size during follow-up. RESULTS: Mean age of the studied population was 66.8 ± 10 years and about 85% were males. All patients presented with NYHA > 2. EuroSCORE ranged between 7 and 15. Patients varied regarding their HAS-BLED score. None of them experienced MAEs at 30 days. Patients showed significant improvement of NHYA functional class, and all echocardiographic measurements such as left ventricular end systolic diameter, left ventricular end diastolic diameter, left ventricular ejection fraction, left atrium volume index and MR grade. They also showed significant improvement of right-side heart failure manifestations (lower limb edema, S3 gallop, neck veins congestion), and laboratory value (the mean Hb levels significantly increased from 11.96 ± 1.57 to 12.97 ± 1.36, while the median CRP significantly decreased from 7 (3-9) to 2 (1-3). As well, the median Pro-BNP significantly decreased from 89.5 (73-380) to 66.5 (53.5-151) following MV clipping. During the whole follow-up period, there was dramatic improvement in the NHYA functional class, echocardiographic assessment including left ventricular ejection fraction, and mitral regurge grade. During follow-up, four patients (20%) developed complications. There was no statistical difference between patients who developed complications and those who did not regarding their age (75.25 ± 12.42 versus 64.63 ± 9.21, respectively), BSA (1.69 ± 0.11 versus 1.79 ± 0.22, respectively), gender (75% versus 87.5% males respectively), MR etiology (75% versus 50% ischemic, 25% versus 50% non-ischemic), or NYHA pre- or post-mitral clipping. However, the median EuroSCORE was significantly higher in the complicated group (13, IQR= 11.5-14.5) than the non-complicated group (9.5, IQR=8.5-11.5). CONCLUSION: Percutaneous usage of MitraClip for mitral valve repair showed favorable reliability and better clinical outcomes. TRIAL REGISTRATION: ZU-IRB#2481-17-2-2016 Registered 17 February 2016, email: IRB_123@medicine.zu.edu.eg.