IntroductionRapid deployment valves (RDV) represent a newly introduced approach to aortic valve replacement which facilitates surgical implantation and minimally invasive techniques, shortens surgical times and shows excellent haemodynamic performance. However, evidence on their safety, efficacy and potential complications is mostly fitted with small-volume and retrospective studies. Moreover, no current guidelines exist. To improve our knowledge on this technology, The Rapid Deployment Aortic Replacement (RADAR) Registry will be established across Spain with the aim of assessing RDV outcomes in the real-world setting.Methods and analysisThe RADAR Registry is designed as a product registry that would provide information on its use and outcomes in clinical practice. This multicentre, prospective, national effort will initially involve 4 centres in Spain. Any patient undergoing cardiac surgery for aortic valve replacement and receiving an RDV as an isolated operation or in combination with other cardiac procedures may be included. Participation is voluntary. Data collection is equal to information obtained during standard care and is prospectively entered by the participating physicians perioperatively and during subsequent follow-up visits. The primary outcome assessed is in-hospital and up to 5 years of follow-up, prosthetic valve functioning and clinical status. Secondary outcomes are to perform subgroup analysis, to compare outcomes with other existing approaches and to develop future clinical guidelines. The follow-up assessments are timed with routine clinical appointments. Dissociated data will be extracted and collectively analysed. Initial target sample size for the registry is 500 participants entered with complete follow-up information. Different substudies will be implemented within the registry to investigate specific populations undergoing aortic valve replacement.Ethics and disseminationThe protocol is approved by all local institutional ethics committees. Findings will be shared by the participant hospitals, policymakers and the academic community to promote quality monitoring and efficient use of this technology.
Introduction: Rapid deployment aortic valve replacement has been recently introduced in clinical practice. Different studies have reported a significant reduction in surgical times with excellent hemodynamic profiles and short-term results. However, an increase in permanent pacemaker requirements compared with conventional aortic valve replacement has been described. Nevertheless, risk factors for postoperative pacemaker implantation are not well known. The aim of this study is to report our early outcomes with rapid deployment aortic valve replacement within the RADAR Registry, especially focusing on risk factors for postoperative pacemaker implantation. Methods: Between April 2012 and January 2016, 164 patients undergoing isolated or combined aortic valve replacement with Edwards INTUITY Elite (Edwards Lifesciences, Irvine, CA, USA) were included in the RADAR Registry. Pre-, intra-and postoperative clinical data results and complications were recorded, especially focusing on risk factors for the development of postoperative complete or high-grade AV block requiring pacemaker implantation. Patients were followed up for up
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