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.
IntroductionSpain is one of the countries with the lowest rates of revascularisation and highest ratio of percutaneous coronary intervention (PCI) to coronary artery bypass grafting (CABG).ObjectivesTo investigate the changes and trends in the two revascularisation procedures between 1998 and 2017 in Spain.DesignRetrospective cohort study. Analysis of in-hospital outcomes.SettingMinimum basic data set from the Spanish National Department of Health: mandatory database collecting information of patients who are attended in the Spanish public National Health System.Participants603 976 patients who underwent isolated CABG or PCI in the Spanish National Health System. The study period was divided in four 5-year intervals. Patients with acute myocardial infarction on admission were excluded.Primary and secondary outcomesWe investigated the volume of procedures nationwide, the changes of the risk profile of patients and in-hospital mortality of both techniques.ResultsWe observed a 2.2-fold increase in the rate of any type of myocardial revascularisation per million inhabitants-year: 357 (1998) to 776 (2017). 93 682 (15.5%) had a coronary surgery. PCI to CABG ratio rose from 2.2 (1998–2002) to 8.1 (2013–2017). Charlson’s index increased by 0.8 for CABG and 1 for PCI. The median annual volume of PCI/hospital augmented from 136 to 232, while the volume of CABG was reduced from 137 to 74. In the two decades, we detected a significant reduction of CABG in-hospital mortality (6.5% vs 2.6%, p<0.001) and a small increase in PCI (1.2% vs 1.5%, p<0.001). Risk adjusted mortality rate was reduced for both CABG (1.51 vs 0.48, p<0.001), and PCI (1.42 vs 1.05, p<0.001).ConclusionWe detected a significant increase in the volume of revascularisations (particularly PCI) in Spain. Risk-adjusted in-hospital mortality was significantly reduced.
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