July 1, 2020
Fuwai Talks about Heart 2020-06-30 Author: Wen Tao
On June 25th at 16:00 local time in Paris, France, at the latest clinical trial session of the European Association for Percutaneous Cardiovascular Intervention (Euro PCR 2020), Professor Xu Yawei from the Tenth People's Hospital of Shanghai, on behalf of the research team, released the latest data of the LEFTEAR left atrial appendage occluder system (see figure), further confirming the effectiveness and safety of the new "disc" occluder LEFTEAR for left atrial appendage occlusion surgery, and received high praise.
1A: Left atrial appendage occluder; 1B: Delivery system (specification 10F), consisting of delivery sheath, expander, delivery cable, and loader
This is another breakthrough on the international academic stage following the LEFTEAR left atrial appendage occlusion system.
This product highlights "Made in China" and has significant social and economic value.
The research presented by Professor Xu in this report is a prospective, multicenter, single group target value design study. Academician Ge Junbo and Professor Xu Yawei are the co main researchers, with nine domestic institutions participating. The main surgeons in each center are mature surgeons who have been performing left atrial appendage occlusion surgery for a long time on the clinical front line, with a duration of more than 2 years.
Each center adopts a competitive enrollment method to enroll cases. From October 2018 to October 22, 2019, the study completed the initial enrollment of 200 patients with non valvular atrial fibrillation.
Among them, 196 patients were implanted with the new "disc" occluder LEFTEAR, while the remaining 4 patients were not implanted with the occluder. One stop "surgery (ablation combined with left atrial appendage occlusion) was performed in 133 cases (67%), with only left atrial appendage occlusion accounting for 31%.
As of December 31, 2019, the average follow-up period was 6 months. There were no major composite endpoint events during the perioperative and follow-up periods.
Among patients implanted with FLEFTEAR, the immediate success rate reached 100%, with no residual shunting observed in 178 cases.
A total of 153 follow-up cases were completed (79.7%, 153/192 cases), all of which underwent at least one transesophageal echocardiography examination. The success rate of left atrial appendage occlusion was 98.7%, and no thrombus formation was observed on the surface of the occluder.
Responsible Editor: Wen Tao, Wang Birong