PCRe Course 2020 heavyweight moment | Professor Yawei Xu reports the latest results of registration research on the new disc left atrial appendage occluder LEFTEAR
Chinese Medical Forum - Today's Circulation "by Li Shuang from the Department of Cardiology, Shanghai Tenth People's Hospital
June 26, 2020 (Beijing time)
Multi center clinical study of a new disc type left atrial appendage occluder: perioperative and mid-term follow-up reports from the LEFTEAR registry study
On June 25th at 16:00 local time in Paris, France, during the Hot line/Late Breaking Trials session of PCR e-Course 2020 Hot lines and Innovation Channel, Professor Xu Yawei from Shanghai Tenth People's Hospital reported on the effectiveness and safety of the LEFTEAR left atrial appendage occluder system for long-term oral anticoagulation therapy contraindications or stroke risk in non valvular atrial fibrillation (AF) patients undergoing left atrial appendage occlusion (LAAC), providing evidence for the effectiveness and safety of the new "disc" occluder LEFTEAR for left atrial appendage occlusion.
Research Background
Left atrial appendage occlusion (LAAC) is a new technique developed in recent years to prevent stroke in patients with atrial fibrillation (AF) by minimally invasive occlusion of the left atrial appendage. The existing occluders can be roughly classified into two types based on the location of occlusion: "plug" and "disc" occluders.
Plug type "occluders, also known as" monolithic "occluders, include WATCHMAN, PLAATO, Lefort, etc. There is a common presence of residual chambers after occlusion surgery, which may become potential sources of thrombosis. More suitable for single leaf left atrial appendage, which accounts for a lower proportion. Not very suitable for shallow or premature lobulation or large opening left atrial appendage. In addition, the push sheath of the "plug type" occluder must be deep at the bottom of the heart ear, which increases the risk of perforation. Moreover, the rivets of the occluder protrude beyond the occlusion filter, increasing the endothelialization time.
Disc type "occluders, also known as" dual body "occluders, include ACP, LAmbre, Lacbes, etc. Due to the diameter of the occluded disc on the atrial surface being larger than the maximum opening of the left atrial appendage, it may affect surrounding structures (such as the left upper pulmonary vein, mitral valve, etc.) and require longer endothelialization time.
Figure 1 "Plug" occluder and "Disc" occluder
The LEFTEAR @ occluder system (hereinafter referred to as LEFTEAR) used in this study is a new type of "disc" occluder, patented and produced by Guangdong Pulse Medical Technology Co., Ltd. In theory, it has better fixation and occlusion performance, and can also shorten the postoperative endothelialization time.
Figure 2 LEFTEAR @ Left atrial appendage occluder system
A. Left atrial appendage occluder (actual picture, size 25 * 37mm). B. The conveying system (physical picture, specification 10F) consists of a conveying sheath, expander, conveying steel cable, and loader.
This study was conducted by Academician Ge Junbo and Professor Xu Yawei as co principal investigators, with participation from nine institutions including Fudan University Affiliated Zhongshan Hospital, Shanghai Tenth People's Hospital, Shanghai Oriental Hospital, Peking University First Hospital, Zhejiang University School of Medicine Affiliated Second Hospital, Xiamen University Affiliated Cardiovascular Disease Hospital, Sichuan University West China Hospital, Xi'an Jiaotong University First Affiliated Hospital, and Tianjin Medical University General Hospital. The main surgeons in each center were mature patients who had been performing LAAC on the clinical front line for more than 2 years or more.
research methodology
This study adopts a prospective, multicenter, single group target value design to evaluate the effectiveness and safety of LEFTEAR for LAAC treatment in patients with non valvular atrial fibrillation.
This study prospectively included a total of 200 atrial fibrillation patients who were planning to undergo LAAC in 9 hospitals across the country. From August 2018 to October 2019, 200 cases were successfully enrolled. The patient's age was (68 ± 8.7) years, ranging from 38 to 89 years old. There were 112 males (56%) with CHA2DS2 VASc score (3.5 ± 1.44) and HAS-BLED score (2.5 ± 1.18).
All enrolled patients were implanted with the new disc occluder LEFTEAR. The standard for successful occlusion of the left atrial appendage is the evaluation of no or minimal residual shunt (PDL ≤ 3 mm) around the occlusion using transesophageal echocardiography (TEE).
Figure 3 Schematic diagram of left atrial appendage measurement
The available depth of the left atrial appendage (Hlaa) is defined as the vertical distance from the distal inner wall of the left atrial appendage to the diameter of the fixed area (D1aa), which needs to be greater than 10mm. For a single leaf left atrial appendage: D1aa, it is defined as the distance from the apex of the mitral valve, which forms a ridge with the left atrial appendage, to the inner wall of the left atrial appendage close to the left upper pulmonary vein. For the double/multi lobe left atrial appendage: Dlaa, it is defined as the ridge formed from the top of the mitral valve and the left atrial appendage, which is essentially perpendicular to the edge of the main bifurcation of the two/more chambers of the left atrial appendage. This type of left atrial appendage also requires measuring the distance (Hmv) from the top of the mitral valve and the left atrial appendage to the main bifurcation of the lobes, which needs to be less than 10mm.
The composite endpoint events within 12 months after surgery (hemorrhagic/ischemic stroke, systemic embolism, cardiac/unexplained death) are the main efficacy indicators; Serious adverse events (SAEs) within 12 months after surgery are used as safety indicators.
Research findings
196 patients were implanted with occluders, while the remaining 4 patients were not implanted with occluders (1 case found that the opening of the left atrial appendage was larger than the upper limit specified in the protocol by 35 mm, 1 case failed to attempt occlusion and gave up, and 2 cases experienced "cardiac tamponade" after completing atrial fibrillation ablation and attempted to continue LAAC). Among them, there were 133 cases of atrial fibrillation treated with "one-stop" surgery (ablation combined with left atrial appendage occlusion).
Figure 4 Selection of surgical procedures
A: The proportion of different surgical methods and compositions. B: The proportion of surgical methods and composition in each center.
As of December 31, 2019, the average follow-up period was 6 (4-11) months. There were no major composite endpoint events during the perioperative and follow-up periods. SAE occurred in patients undergoing "one-stop" surgery, with 7 cases of "cardiac tamponade" and 3 cases of occluder detachment or significant displacement. Among them, 9 cases occurred during the perioperative period, 6 cases had "cardiac tamponade", and only 2 cases required emergency surgical intervention; Three cases of occluder detachment or significant displacement.
Figure 5 "CODIS" principle evaluation of whether LEFTEAR occluder is successfully occluded
A: The fixed disk is unfolded behind the revolving support (LCx), and the red arrow indicates the opening position of LCx under TEE; B: The fixed disk is fully unfolded (Open), and the end of the fixed disk is in line with the development mark connected between the sealing disk and the fixed disk (red dashed line); C: The Dish should have a certain relative deformation; I: Ensure firm fixation through tensile testing (Insurance); S: The sealing disk has been successfully sealed, and the red dashed line indicates that there is no residual flow at the upper and lower edges of the sealing disk.
Among the 196 patients implanted with LEFTEAR, the immediate success rate reached 100%, with 178 cases showing no residual shunting. A total of 153 follow-up cases (79.7%, 153/192 cases) have been completed. Among patients who have completed at least one TEE examination, the successful occlusion rate of the left atrial appendage was 98.7% (151/153 cases), and no thrombus formation on the surface of the occluder was observed (0%).
research findings
The application of the new "disc" occluder LEFTEAR for left atrial appendage occlusion is generally effective and safe. The "one-stop" procedure of atrial fibrillation ablation combined with left atrial appendage occlusion has to some extent increased the occurrence of adverse events.
Expert Profile
Xu Yawei, Doctor of Medicine, Second Class Professor, Chief Physician, Doctoral Tutor, Expert with Special Government Allowance of the State Council, model worker of Shanghai, the first ten kind-hearted doctors of Shanghai, the second national famous doctors, the third Bethune style good doctor nomination award, and medical craftsman of Shanghai in 2020. The current director of the Heart Center at Shanghai Tenth People's Hospital and the director of the Institute of Panvascular Disease at Tongji University School of Medicine.
Part time positions: Chief Scientist of the National Key R&D Program, Vice Chairman of the Internal Medicine Branch of the Chinese Medical Association, Vice President of the Cardiovascular Medicine Branch of the Chinese Medical Association, President of the Cardiovascular Medicine Branch of the Shanghai Medical Association, Vice Chairman of the Internal Medicine Specialty Branch of the Shanghai Medical Association, Vice President and Secretary General of the World Association of Chinese Cardiovascular Physicians (WACC), Vice Chairman of the Chinese Chest Pain Center Alliance, Vice Dean of the Atrial Fibrillation College of the Chinese Atrial Fibrillation Center, Executive Chairman of the Shanghai Chest Pain Center Alliance, etc.
For many years, I have been engaged in clinical and scientific research on cardiovascular diseases, with comprehensive skills, and have been committed to the treatment of acute myocardial infarction for more than 30 years.
Li Shuang, attending physician, MD. Currently serving as the attending physician and chief resident physician of the Department of Cardiology at the Tenth People's Hospital of Shanghai (also known as Tongji University Affiliated Tenth People's Hospital).
Mainly engaged in interventional therapy and pacing therapy for arrhythmia, with certain research in radiofrequency ablation, cryoablation, left atrial appendage occlusion, etc. Published multiple clinical studies in authoritative medical journals such as EuroIntervention, Cardiology Plus, Heart lung and circulation, Chinese Journal of Cardiovascular Disease, and Chinese Journal of Arrhythmology, and co authored three monographs. Present thematic research at international and domestic conferences such as HRS, Great Wall Conference, Oriental Conference, CIT, etc. Has 2 invention patents and is one of the inventors of Lefear left atrial appendage occlusion device. Has won the "Shanghai First Employee Innovation Award" for related research on the device. Hosted a National Natural Science Foundation youth project.
Dr. Li Shuang has long been committed to the popularization and promotion of cardiovascular diseases. He is officially recognized as a "heart hero" by Today's Headlines and the China Cardiovascular Alliance, responsible for popularizing medical knowledge to the public. He has been certified as "Dr. Li Shuang, a specialist in cardiology" on the "Today's Headlines" app.