0000000000666955
AUTHOR
Stephan Kische
TCT-350 Safety and Performance of the Resorbable Magnesium Scaffold, Magmaris in a Real World Setting - First 400 Subjects at 12-month Follow-up of the BIOSOLVE-IV Registry
The aim of this registry is to investigate the clinical performance and long-term safety of the Resorbable Magnesium Scaffold (Magmaris) (BIOTRONIK AG, Buelach, Switzerland) in a real-world setting. Up to 2,054 subjects in up to 120 clinical sites in Europe, Asia, and Asia-Pacific countries will
A multicentre European registry to evaluate the Direct Flow Medical transcatheter aortic valve system for the treatment of patients with severe aortic stenosis.
Aims Our aim was to assess the clinical outcomes of the Direct Flow Medical Transcatheter Aortic Valve System (DFM-TAVS), when used in routine clinical practice. Methods and results This is a prospective, open-label, multicentre, post-market registry of patients treated with DFM-TAVS according to approved commercial indications. Echocardiographic and angiographic data were evaluated by an independent core laboratory and adverse events were adjudicated and classified according to VARC-2 criteria by an independent clinical events committee. The primary endpoint was freedom from all-cause mortality at 30 days post procedure. Secondary endpoints included procedural, early safety and efficacy en…
Initial and long-term antithrombotic therapy after left atrial appendage closure with the WATCHMAN
Abstract Background Evidence regarding post-procedural antithrombotic regimes other than used in randomized trials assessing percutaneous left atrial appendage (LAA) closure is limited. Purpose The present work aimed to compare different antithrombotic strategies applied in the real-world EWOLUTION study. Methods A total of 998 patients with successful WATCHMAN implantation at 47 centers were available for the present analysis. The composite ischemic endpoint of stroke, TIA, systemic embolism and device thrombus as well as the bleeding endpoint defined as at least major bleeding according to BARC were assessed during an initial period (from implant until first medication change) and long-te…