Mohamed Ali Abukar, Wasim Daanyaal, Løland Kjetil Halvorsen, Rotevatn Svein, Bleie Øyvind, Saeed Sahrai
Department of Heart Disease, Haukeland University Hospital, Bergen, Norway.
Norwegian Registry of Invasive Cardiology (NORIC), Bergen, Norway.
BMJ Open. 2021 Jan 20;11(1):e039961. doi: 10.1136/bmjopen-2020-039961.
Transcatheter aortic valve implantation (TAVI) is a widely used treatment option as an alternative to surgical aortic valve replacement in patients with severe aortic stenosis (AS) at high or intermediate surgical risk. TAVI improves symptoms, induces reverse left ventricular (LV) remodelling and increases overall survival. However, a careful patient selection is essential to achieve better outcome. Evidence on LV functional recovery and LV mass regression after TAVI based on contemporary registry data is scarce. The impact of TAVI on the arterial vasculature is also less explored.
This is a study of 600 consecutive patients with AS who underwent a TAVI at Haukeland University Hospital, Bergen, Norway. Demographics, clinical data, arterial haemodynamics and echocardiographic parameters were prospectively collected. In the present paper, we describe the design, major scientific objectives and echocardiography imaging protocol of the TAVI-NOR (TAVI in western NORway) study. The main objectives are: To explore the impact of TAVI on cardiac structure and function in patients with severe AS, identify the echocardiographic predictors of reverse LV remodelling, assess survival benefits according to baseline risk profile, evaluate long-term therapeutic success as reflected by reduction in valvular-arterial impedance and to investigate the impact of various types of blood pressure response immediately after TAVI on clinical outcome.
The study was approved by the Regional Committees for Medical and Health Research Ethics (REK vest, ref. number 33814) and the Institutional Data Protection Services. Patients' consent was waived. The study findings will be disseminated via peer-reviewed publications and presentation in national and international scientific meetings and conferences.
The study was registered in the international database: ClinicalTrials.gov, Identifier: NCT04417829.
经导管主动脉瓣植入术（TAVI）是一种广泛应用的治疗选择，用于替代手术主动脉瓣置换术，治疗手术风险高或中等的严重主动脉瓣狭窄（AS）患者。TAVI可改善症状，促使左心室（LV）逆向重构，并提高总体生存率。然而，仔细的患者选择对于取得更好的治疗效果至关重要。基于当代注册数据，关于TAVI后左心室功能恢复和左心室质量消退的证据较少。TAVI对动脉血管系统的影响也较少被探讨。
本研究纳入了挪威卑尔根豪克兰大学医院连续600例接受TAVI的AS患者。前瞻性收集了人口统计学、临床数据、动脉血流动力学和超声心动图参数。在本文中，我们描述了挪威西部TAVI（TAVI-NOR）研究的设计、主要科学目标和超声心动图成像方案。主要目标包括：探讨TAVI对严重AS患者心脏结构和功能的影响，确定左心室逆向重构的超声心动图预测指标，根据基线风险状况评估生存获益，评估瓣膜-动脉阻抗降低所反映的长期治疗成功情况，以及研究TAVI后即刻不同类型血压反应对临床结局的影响。
本研究已获得地区医学和健康研究伦理委员会（REK vest，参考编号33814）和机构数据保护服务部门的批准。患者同意书被豁免。研究结果将通过同行评审出版物以及在国内和国际科学会议上的报告进行传播。
本研究已在国际数据库ClinicalTrials.gov注册，标识符：NCT04417829。
