Bautista-Hernandez Victor, Cal-Purriños Natalia, Arribas-Leal Jose M, Carnero-Alcazar Manuel, Gutierrez-Diez Jose F, Cuenca-Castillo Jose J
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.
BMJ Open. 2017 Jan 10;7(1):e011437. doi: 10.1136/bmjopen-2016-011437.
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.
快速部署瓣膜（RDV）是一种新引入的主动脉瓣置换方法，它便于手术植入和微创技术，缩短手术时间并显示出优异的血流动力学性能。然而，关于其安全性、有效性和潜在并发症的证据大多来自小样本量和回顾性研究。此外，目前尚无相关指南。为了增进我们对这项技术的了解，西班牙将建立快速部署主动脉置换（RADAR）注册库，旨在评估真实世界环境中RDV的治疗效果。
RADAR注册库被设计为一个产品注册库，将提供其在临床实践中的使用和治疗效果信息。这项多中心、前瞻性的全国性工作最初将涉及西班牙的4个中心。任何因主动脉瓣置换而接受心脏手术并接受RDV作为单独手术或与其他心脏手术联合使用的患者均可纳入。参与是自愿的。数据收集等同于在标准护理期间获得的信息，并由参与的医生在围手术期和随后的随访中前瞻性地输入。评估的主要结局是住院期间以及长达5年的随访、人工瓣膜功能和临床状况。次要结局是进行亚组分析，将治疗效果与其他现有方法进行比较，并制定未来的临床指南。随访评估与常规临床预约时间一致。将提取离散数据并进行综合分析。注册库的初始目标样本量为500名参与者，并输入完整的随访信息。将在注册库内开展不同的子研究，以调查接受主动脉瓣置换的特定人群。
该方案已获得所有当地机构伦理委员会的批准。研究结果将由参与的医院、政策制定者和学术界分享，以促进对该技术的质量监测和有效利用。
