Bjursten Henrik, Nozohoor Shahab, Johansson Malin, Zindovic Igor, Appel Carl-Fredrik, Sjögren Johan, Dencker Magnus, Olivecrona Göran, Harnek Jan, Koul Sasha, Feldman Ted, Reardon Michael J, Götberg Matthias
Department of Cardiothoracic Surgery, and Cardiology, Institute of Clinical Sciences, Lund University, Skane University Hospital, SE-221 85, Lund, Sweden.
Department of Clinical Physiology, and Cardiology, Institute of Clinical Sciences, Lund University, Skane University Hospital, Lund, Sweden.
BMC Cardiovasc Disord. 2017 Jan 13;17(1):25. doi: 10.1186/s12872-016-0466-1.
In the evolving field of transcatheter aortic valve replacements a new generation of valves have been introduced to clinical practice. With the complexity of the TAVR procedure and the unique aspects of each TAVR device, there is a perceived risk that changing or adding a new valve in a department could lead to a worse outcome for patients, especially during the learning phase. The objective was to study the safety aspect of introducing a second generation repositionable transcatheter valve (Boston Scientific Lotus valve besides Edwards Sapien valve) in a department.
In a retrospective study, 53 patients receiving the Lotus system, and 47 patients receiving the Sapien system over a period of three years were compared for short-term outcome according to VARC-2 definitions and 1-year survival.
Outcome in terms VARC-2 criteria for early safety and clinical efficacy, stroke rate, and survival at 30 days and at 1 year were similar. The Lotus valve had less paravalvular leakage, where 90% had none or trace aortic insufficiency as compared to only 48% for the Sapien system.
Introduction of a new generation valve can be done with early device success and safety, and without jeopardizing the outcome for patients up to one year. We found no adverse effects by changing valve type and observed improved outcome in terms of lower PVL-rates. Both existing and new centers starting a TAVR program can benefit from the use of a new generation device.
在经导管主动脉瓣置换术不断发展的领域中，新一代瓣膜已引入临床实践。鉴于经导管主动脉瓣置换术（TAVR）操作的复杂性以及每种TAVR设备的独特之处，人们认为在一个科室更换或添加新瓣膜可能会给患者带来更差的预后，尤其是在学习阶段。目的是研究在一个科室引入第二代可重新定位经导管瓣膜（除了爱德华兹Sapien瓣膜外的波士顿科学公司Lotus瓣膜）的安全性。
在一项回顾性研究中，根据VARC-2定义，比较了53例接受Lotus系统治疗的患者和47例在三年期间接受Sapien系统治疗的患者的短期预后及1年生存率。
根据VARC-2标准，早期安全性、临床疗效、卒中发生率以及30天和1年生存率方面的预后相似。Lotus瓣膜的瓣周漏较少，90%的患者无或仅有微量主动脉瓣关闭不全，而Sapien系统只有48%。
引入新一代瓣膜可以在早期获得设备成功和安全性，且不会危及患者长达一年的预后。我们发现更换瓣膜类型没有不良影响，并且在降低瓣周漏发生率方面观察到预后改善。开展TAVR项目的现有中心和新中心都可以从使用新一代设备中获益。
