Update on percutaneous mitral valve therapy: clinical results and real life experience.

Mitral regurgitation (MR) is a common valvulopathy worldwide increasing in prevalence. Cardiac surgical intervention, preferable repair, is the standard of care, but a relevant number of patients with severe MR do not undergo surgery because of high peri-operative risk. Percutaneous mitral valve repair with the MitraClip System has evolved as a new tool for the treatment of severe MR. The procedure simulates the surgical edge-to-edge technique, developed by Alfieri in 1991, creating a double orifice valve by a permanent approximation of the two mitral valve leaflets. Several preclinical studies, registries and Food and Drug Administration approved clinical trials (EVEREST, ACCESS-EU) are currently available. The percutaneous approach has been recently studied in a randomized controlled trial, concluding that the device is less effective at reducing MR, when compared with surgery, by associated with a lower adverse event rate. The patients enrolled in this trial had a normal surgical risk and mainly degenerative MR with preserved left ventricular function. On the other hand, results derived from the clinical "real life" experience, show that patients actually treated in Europe present a higher surgical risk profile, more complex mitral valve anatomy and functional MR in the most of cases. Thus these data suggest that MitraClip procedure is feasible and safe in this subgroup of patients that should be excluded from the EVEREST trial due to rigid exclusion criteria. Despite the promising results clinical experience is still small, and no data related the durability are currently available. Therefore, MitraClip device should be reserved now to high risk or inoperable patients.

Long term results of unprotected left main percutaneous coronary intervention with DES versus BMS.

AIM: Stenosis in the unprotected left main coronary artery (ULMCA) is considered a standard indication for surgical revascularization. Some studies have demonstrated that stenting of the ULMCA is safe and feasible in selected patients. Drug eluting stents (DES) have been shown to be superior to bare metal stents (BMS) in reducing restenosis and major adverse cardiac events (MACE) both in-hospital and at follow-up after treatment of ULMCA disease. Several studies showed that the mid-term prognosis of patients with left main stenting is good, but most of them are limited by small populations and the availability of mid-term results. Thus, we sought to evaluate the very long term impact of DES vs BMS in a large cohort of patients undergoing stent implantation for ULMCA disease in our center. METHODS: Between June 2002 and June 2008 a total of 354 consecutive patients with ULMCA stenosis were treated with percutaneous coronary intervention with BMS (53 patients) or DES (301 patients) implantation. A multivariable adjustment was provided in order to account for baseline differences between groups. RESULTS: The average clinical follow-up was 551+/-512 days. Overall, MACE rate was significantly lower in the DES group (16.6% vs 26.4%, P=0.02). The beneficial effect was driven by a reduction of death (6.0% vs 9.4%, P=0.11), MI (2.7% vs 3.8%, P=0.33) and target vessel revascularization after DES implantation (9.0 % vs 15.1%, P=0.11). After correcting for independent predictors of adverse events, the adjusted hazard ratios (HRs) for the risk of mortality and myocardial infarction after DES implantation relative to BMS implantation were 0.99 (95% CIs 0.30-3.21, P=0.98) and 0.59 (95% CIs 0.01-3.45, P=0.56), respectively. The adjusted HR for two-year MACE was 0.50 (95 CIs 0.25-1.02), P=0.056, mainly driven by a statistical significant reduction of TVR (HR 0.30 [95 CIs 0.11-0.82], P=0.018]. CONCLUSIONS: Patients presenting with ULMCA disease, who are treated with DES have a significant reduction in the rate of target lesion revascularization with no increased risk of death or myocardial infarction.