A prospective, multi-center, single-arm study of a novel double-disc left atrial appendage closure system: The periprocedural and mid-term outcomes (english version)

Background: Percutaneous left atrial appendage (LAA) closure has been demonstrated to be an alternative to oral anticoagulation for the prevention of ischemic stroke in nonvalvar atrial fibrillation (NVAF) patients. However, there were some designed limitations of current widely-used devices. This study was designed to evaluate the efficacy and safety of a novel double-disc LAA closure (LAAC) device, the LEFTEAR, in patients with NVAF who had contraindications of long-term oral anticoagulation or still high risks of stroke with anticoagulation treatment. Subjects and Methods: A total of 200 NVAF patients who underwent LAAC were prospectively recruited in nine participating centers in China between April 2014 and March 2019 in this prospective, multi-center, single-arm study. The study was approved by the institutional review board of each clinical center. The enrolled cases had ages ranged from 38 to 89 years (mean 68.3 ± 8.7) years. There were 112 males (56%). CHA2DS2-VASc scores were 3.5 ± 1.44, and HAS-BLED scores 2.5 ± 1.18. LAAC was conducted with the LEFTEAR occluder. Successful closure of LAA was defined as there was no or a small amount of peri-device leak (PDL ≤3 mm) of residual shunt, evaluated by transesophageal echocardiography. The composite end-point events (hemorrhagic/ischemic stroke, systemic embolism, and cardiogenic/unexplained death) within 12 months after the procedure were the main efficacy indicators. Severe adverse events (SAEs) within 12 months were safety indicators. Results: Totally 196 were implanted with an occluder, and the remaining 4 were not (1 case found with an large LAA which the ostium was great than 35 mm, the upper limit of the clinical program, 1 case gave up after failed attempt of LAAC procedure, 2 cases showed “pericardial tamponade” after AF ablation and no attempts were made to continue LAAC). Among them, the “Hybrid procedures” (LAAC combined with AF ablation) reached up to 133 cases (66.5%). Up to December 31, 2019, the mean follow-up was 6 months. There were none major composite endpoint events occurred during the perioperative and follow-up periods (0%). SAEs were recorded in 10 cases, of which 7 were “pericardial tamponades” and 3 of “occluder detachment or displacements.” All SAEs occurred in “Hybrid procedures” cases, of which 9 occurred in the perioperative period (90%). Six cases of “pericardial tamponade” were recorded in the perioperative period, but only two required emergency surgeries. The successful rate of immediate LAAC was 100%, among which 178 cases (90.8%, 178/196) had no residual shunt (PDL = 0 mm). A total of 153 cases (79.7%, 153/192) had completed at least one follow-up transoesophageal echocardiography examination, and the success of mid-term LAAC was 98.7% (151/153), with no events of device-related thrombosis. Conclusions: LAAC with a novel disc-like occlude, named LEFTEAR was generally effective and safe. The “Hybrid procedures” increased the incidence of adverse events to some extent. This study was the first-in-human trial of LEFTEAR, thus further larger sample studies are still needed to verify.