The FRANCE TAVI registry provided reassuring data regarding trends in TAVR performance in an all-comers population on a national scale. Nonetheless, given that TAVR indications are likely to expand to patients at lower surgical risk, concerns remain regarding potentially life-threatening complications and pacemaker implantation. (Registry of Aortic Valve Bioprostheses Established by Catheter [FRANCE TAVI]; NCT01777828).
The FRANCE-2 registry represents the largest database available on late results of TAVR. Late mortality is largely related to noncardiac causes. Incidence rates of severe events are low after the first month. Valve performance remains stable over time.
The RA provides the same clinical and angiographic results both as aorto-coronary and composite Y-graft with the left ITA. When the RA is used as Y-graft the procedure is more technically demanding and a greater number of distal coronary anastomoses is possible. RA grafts to targets with stenosis < or = 70% appear to be at risk of failure.
The LITA shows a marked adaptability to flow dynamics. The proximal tract of the LITA in Y-group is able to match increased flow requirements, probably through the release of endothelial vasoactive mediators. Flow velocity spectra acquired in the proximal LITA in Y-group resemble the biphasic coronary artery pattern with a clear diastolic predominance. This pattern is probably consequence of the increase of blood flow due to the lower vascular resistance of the Y-graft system and to the active dilatation of the LITA.
BackgroundAortic valve stenosis is one of the most common heart diseases in older patients. Nowadays, surgical aortic valve replacement is the ‘gold standard’ treatment for this pathology and the most implanted prostheses are biological ones. The three most implanted bovine bioprostheses are the Trifecta valve (St. Jude Medical, Minneapolis, MN, USA), the Mitroflow valve (Sorin Group, Saluggia, Italy), and the Carpentier-Edwards Magna Ease valve (Edwards Lifesciences, Irvine, CA, USA). We propose a randomized trial to objectively assess the hemodynamic performances of these bioprostheses.Methods and designFirst, we will measure the aortic annulus diameter using CT-scan, echocardiography and by direct sizing in the operating room after native aortic valve resection. The accuracy of information, in terms of size and spatial dimensions of each bioprosthesis provided by manufacturers, will be checked. Their hemodynamic performances will be assessed postoperatively at the seventh day and the sixth month after surgery.DiscussionThis prospective controlled randomized trial aims to verify and compare the hemodynamic performances and the sizing of these three bioprostheses. The data obtained may help surgeons to choose the best suitable bioprosthesis according to each patient’s morphological characteristics.Trial registrationClinicalTrials.gov Identifier: NCT01522352
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