EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
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Randomized Controlled Trial Multicenter Study Comparative Study
The MITRA-FR study: design and rationale of a randomised study of percutaneous mitral valve repair compared with optimal medical management alone for severe secondary mitral regurgitation.
Percutaneous mitral valve repair (pMVR) is a new therapeutic option for mitral valve regurgitation. Positive preliminary results in non-randomised studies have been published supporting the use of the MitraClip system in patients with secondary mitral regurgitation (MR) and poor left ventricular (LV) function contraindicated to surgery. The aim of the MITRA-FR study is to provide a higher level of evidence for the efficacy of the MitraClip device in this setting. ⋯ MITRA-FR is a randomised controlled national trial designed to evaluate the performance of pMVR in comparison to OMT in patients with severe symptomatic secondary MR contraindicated to cardiac surgery.
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Multicenter Study
Twelve-month results of the rapid renal sympathetic denervation for resistant hypertension using the OneShotTM ablation system (RAPID) study.
Renal denervation has emerged as a treatment option for patients with drug-resistant hypertension. This study was designed to assess the safety and effectiveness of the OneShotª Renal Denervation System. ⋯ The results of the RAPID study demonstrate safe delivery of RF energy by the OneShot Renal Denervation System for renal sympathetic denervation and sustained efficacy, as evidenced by a significant reduction in office and 24-hour ABPM for six months, which was sustained up to 12 months. ClinicalTrials.gov Identifier: NCT01520506.
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Elevated filling pressures of the left atrium (LA) are associated with poorer outcomes in patients with chronic heart failure. The V-Wave is a new percutaneously implanted device intended to decrease the LA pressure by the shunting of blood from the LA to the right atrium. This report describes the first-in-man experience with the V-Wave device. ⋯ Left atrial decompression through a unidirectional left-to-right interatrial shunt represents a new concept for the treatment of patients with left ventricular failure. The present report shows the feasibility of applying this new therapy with the successful and uneventful implantation of the V-Wave device, which was associated with significant improvement in functional, quality of life and haemodynamic parameters at 90 days.
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Bioresorbable scaffolds promise to counteract late thrombosis by the absence of residual foreign material over time and the restoration of functional endothelial coverage. However, although currently available data are controversial, initial post-marketing studies have raised some concerns about the putative increased early thrombogenicity of bioresorbable scaffolds as compared to currently available second-generation drug-eluting stents. This article focuses on incidence rates, putative mechanisms and prevention strategies of scaffold thrombosis.