De Backer Ole, Götberg Matthias, Ihlberg Leo, Packer Erik, Savontaus Mikko, Nielsen Niels E, Jørgensen Troels H, Nykänen Antti, Baranowski Jacek, Niemelä Matti, Eskola Markku, Bjursten Henrik, Søndergaard Lars
The Heart Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Department of Cardiology, Skåne University Hospital, Lund, Sweden.
Int J Cardiol. 2016 Sep 15;219:92-7. doi: 10.1016/j.ijcard.2016.05.072. Epub 2016 May 31.
Transcatheter aortic valve replacement (TAVR) has become an established therapeutic option for patients with symptomatic, severe aortic valve stenosis (AS) who are ineligible or at high risk for conventional valvular surgery. In Northwestern Europe, the TAVR technology is also increasingly used to treat patients with an intermediate risk profile.
The study was designed as an independent Nordic multicenter registry of intermediate risk patients treated with the Lotus Valve System (Boston Scientific, MA, USA; N=154). Valve Academic Research Consortium (VARC)-defined device success was obtained in 97.4%. A Lotus Valve was successfully implanted in all patients. There was no valve migration, embolization, ectopic valve deployment, or TAV-in-TAV deployment. The VARC-defined combined safety rate at 30days was 92.2%, with a mortality rate of 1.9% and stroke rate of 3.2%. The clinical efficacy rate after 30days was 91.6% - only one patient had moderate aortic regurgitation. When considering only those patients in the late experience group (N=79), the combined safety and clinical efficacy rates were 93.7% and 92.4%, respectively. The pacemaker implantation rate was 27.9% - this rate was 12.8% in case of a combined implantation depth <4mm and a device/annulus ratio<1.05.
The present study demonstrates the efficacy and safety of the repositionable, retrievable Lotus Valve System in intermediate risk patients with AS. The VARC-defined device success rate was 97.4% with a 30-day patient safety and clinical efficacy rate of more than 90%. Less than moderate aortic regurgitation was obtained in 99.4% of patients.
经导管主动脉瓣置换术（TAVR）已成为有症状的严重主动脉瓣狭窄（AS）患者的既定治疗选择，这些患者不符合传统瓣膜手术的条件或处于高风险。在欧洲西北部，TAVR技术也越来越多地用于治疗具有中度风险特征的患者。
本研究设计为一项独立的北欧多中心注册研究，纳入使用Lotus瓣膜系统（美国马萨诸塞州波士顿科学公司；N = 154）治疗的中度风险患者。瓣膜学术研究联盟（VARC）定义的器械成功率为97.4%。所有患者均成功植入了Lotus瓣膜。未发生瓣膜移位、栓塞、异位瓣膜植入或TAV-in-TAV植入。30天时VARC定义的综合安全率为92.2%，死亡率为1.9%，卒中率为3.2%。30天后的临床有效率为91.6%——只有1例患者有中度主动脉瓣反流。仅考虑晚期经验组的患者（N = 79）时，综合安全率和临床有效率分别为93.7%和92.4%。起搏器植入率为27.9%——在联合植入深度<4mm且器械/瓣环比<1.05的情况下，该率为12.8%。
本研究证明了可重新定位、可回收的Lotus瓣膜系统在中度风险AS患者中的有效性和安全性。VARC定义的器械成功率为97.4%，30天患者安全率和临床有效率超过90%。99.4%的患者获得了小于中度的主动脉瓣反流。
