Risk Factors for Postoperative Pacemaker Implantation After Rapid Deployment Aortic Valve Replacement: Results from the RADAR Registry.

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 to 1 year with evaluation of clinical and echocardiographic outcomes. RESULTS: A total of 164 consecutive patients were included in this study, where 128 patients (78.05%) had an isolated aortic valve replacement (group 1) and 36 (21.95%) a concomitant procedure (group 2). The surgical approach was ministernotomy in 61 patients (37.20%) and median sternotomy in 100 patients (60.98%). Complications with valve implantation were observed in three patients. Postoperative complete or high-degree AV block requiring a permanent pacemaker implantation developed in ten patients (6.9%). Seven patients died in-hospital (4.27%). No significant differences between groups were found in terms of stroke, postoperative infection, mortality, atrial fibrillation and postoperative atrioventricular block. Seven patients presented acute renal impairment (5.51%) in group 1 versus seven patients (20%) in group 2 (p = 0.007). In multivariate analysis, low weight and preoperative arrhythmia (atrial fibrillation, bifascicular block, left bundle branch block) emerged as risk factors for postoperative AV block requiring a pacer. In median follow-up of 1 year, seven (4.27%) patients died, and no cases of structural valve deterioration or endocarditis were observed. Significant patient-prosthesis mismatch was found in seven (4.27%) patients. CONCLUSION: Initial experience with rapid deployment aortic valve replacement in the RADAR Registry demonstrates low rates of implantation complications and good perioperative and 1-year clinical and echocardiographic outcomes. Incidence of postoperative AV block requiring a pacer correlated with low weight and preoperative arrythmias (atrial fibrillation, bifascicular block and left bundle branch block). Avoidance of oversizing and careful consideration of implantation of this technology in patients with pre-existing arrythmias could minimize the risk for postoperative pacemaker implantation.

Aportes sobre el editorial: «Importancia de los Comités de Ética en la Investigación en Medicina de Familia» / Contributions on the editorial: "Importance of Research Ethics Committees in Family Medicine"

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Rapid Deployment Aortic Replacement (RADAR) Registry in Spain: a protocol.

INTRODUCTION: 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. METHODS AND ANALYSIS: 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. ETHICS AND DISSEMINATION: 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.

Biobancos y su importancia en el ámbito clínico y científico en relación con la investigación biomédica en España / Biobanks and their importance in the clinical and scientific fields related to Spanish biomedical research

La realidad de la investigación biomédica en España, exige tener un conocimiento actualizado de la realidad investigadora y de su marco ético/legal. Los estudios de investigación con muestras biológicas humanas deben realizarse con un número de muestras lo suficientemente amplio para reflejar la diversidad de la población humana. Asimismo, deben cumplir los requisitos estandarizados de calidad óptima para garantizar los resultados de la investigación a desarrollar. Además, la investigación con seres humanos, y la obtención y/o derivación de muestras biológicas humanas e información clínica a estudios de investigación, está sujeta a una serie de requisitos y restricciones legales. Los biobancos y las redes de biobancos se constituyen como la estructura óptima que favorece el almacenamiento de grandes volúmenes de muestras biológicas humanas gestionadas en base a criterios que garanticen su óptima calidad, armonización y seguridad, respetando en todo momento los requisitos éticos y legales que garantizan los derechos de los ciudadanos (AU)

The reality of biomedical research in Spain requires having an updated knowledge of the research reality and its ethical/legal framework. Research studies with human biological samples should be made with a sufficiently large number of samples to reflect the diversity of the human population, which meets the standard requirements to ensure optimum quality of the research results for further development. Furthermore, research with humans, and obtaining and/or deriving human biological samples and clinical research studies information is subject to a number of legal requirements and restrictions. Biobanks and biobank networks are established as the optimal structures that favor the storage of large volumes of human biological samples based on criteria to ensure their optimum quality, harmonization and security, respecting at all times, the ethical and legal requirements guaranteeing the rights of citizens (AU)

Biobanks and their importance in the clinical and scientific fields related to Spanish biomedical research.

The reality of biomedical research in Spain requires having an updated knowledge of the research reality and its ethical/legal framework. Research studies with human biological samples should be made with a sufficiently large number of samples to reflect the diversity of the human population, which meets the standard requirements to ensure optimum quality of the research results for further development. Furthermore, research with humans, and obtaining and/or deriving human biological samples and clinical research studies information is subject to a number of legal requirements and restrictions. Biobanks and biobank networks are established as the optimal structures that favor the storage of large volumes of human biological samples based on criteria to ensure their optimum quality, harmonization and security, respecting at all times, the ethical and legal requirements guaranteeing the rights of citizens.