Five-year outcomes after left atrial appendage closure using LAmbre: From a premarket registered case-series study

Abstract

Objectives: Percutaneous left atrial appendage (LAA) closure has been demonstrated to be an alternative to oral anticoagulation for the prevention of ischemic stroke in non-valvular atrial fibrillation (AF) patients using WATCHMAN. However, few data are available for the novel LAmbre occluder, especially long-term data. This study aimed to evaluate the feasibility of the LAmbre LAA occluder, over more than 5 years of follow-up. Methods: This study included 66 consecutive AF patients implanted with the LAmbre device from April 2014 to October 2015 in our center. Patients received 3-month dual antiplatelet therapy, and single therapy thereafter. Patients were followed-up until July 7, 2020. Results: The mean CHA2DS2-VASc and HAS-BLED scores were 6.0 ± 1.6 and 3.0 ± 0.8, respectively. The implantation success rate was 98.5%. No death, stroke, major bleeding, or device-related severe events were observed within 7 days of the procedure. Adequate LAA sealing was observed in 98.3% and 98.2% of patients at, 3- and 12-month follow-up echocardiographic examinations, respectively. After a mean follow-up of 67 ± 12.1 months, all-cause death was observed as 2.5 per 100 patient-years (n = 9). Equivalent values for ischemic stroke and major bleeding were 1.9 per 100 patient-years (n = 7) and 0.8 per 100 patient-years (n=3), respectively, both significantly lower than the cumulative expected rates according to risk factors. Conclusions: In patients with AF, the protocol of LAAC with the LAmbre device plus antiplatelet therapy was feasible and associated with few ischemic and bleeding events in the periprocedural period and in long-term follow-up of over 5 years.

Keywords

• atrial fibrillation
• left atrial appendage closure
• lambre
• safety
• feasibility