title: Rapid Deployment Aortic Replacement (RADAR) Registry in Spain: a protocol.
abstract: Rapid 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.
  
  
  
  The 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.
  
  
  
  The 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.
authors.affiliation: Department of Cardiovascular Surgery, Xerencia de Xestión Integrada A Coruña (XXIAC), A Coruña, Spain.|Congenital and Structural Heart Disease, Instituto de Investigación Biomédica A Coruña (INIBIC), A Coruña, Spain.
authors.forename: Victor
authors.identifier: 0000-0002-0379-1712
authors.initials: V
authors.lastname: Bautista-Hernandez
authors.affiliation: Fundación Profesor Novoa Santos, Xerencia de Xestión Integrada A Coruña (XXIAC), A Coruña, Spain.
authors.forename: Natalia
authors.initials: N
authors.lastname: Cal-Purriños
authors.affiliation: Department of Cardiovascular Surgery, Hospital Virgen de la Arrixaca, Murcia, Spain.
authors.forename: Jose M
authors.initials: JM
authors.lastname: Arribas-Leal
authors.affiliation: Department of Cardiovascular Surgery, Hospital Clínico de San Carlos, Madrid, Spain.
authors.forename: Manuel
authors.initials: M
authors.lastname: Carnero-Alcazar
authors.affiliation: Department of Cardiovascular Surgery, Hospital Marqués de Valdecilla, Santander, Spain.
authors.forename: Jose F
authors.initials: JF
authors.lastname: Gutierrez-Diez
authors.affiliation: Department of Cardiovascular Surgery, Xerencia de Xestión Integrada A Coruña (XXIAC), A Coruña, Spain.
authors.forename: Jose J
authors.initials: JJ
authors.lastname: Cuenca-Castillo
mesh_terms: D001024:Aortic Valve Stenosis / Q000401:mortality / Q000601:surgery*; D002985:Clinical Protocols; D003625:Data Collection; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000379:methods* / Q000401:mortality; D006801:Humans; D011050:Policy Making; D011446:Prospective Studies; D012042:Registries / Q000706:statistics & numerical data*; D013030:Spain / Q000453:epidemiology; D015996:Survival Rate / Q000639:trends; D016896:Treatment Outcome