Why the study?
Patients with non-valvular atrial fibrillation and previous stroke have a significantly higher risk of stroke recurrence, motivating evaluation of the LAmbre device in this population.
Does left atrial appendage occlusion using the LAmbre device prevent stroke, TIA, systemic embolism, or cardiac death in NVAF patients with a history of stroke or TIA?
Does left atrial appendage occlusion using the LAmbre device prevent stroke, TIA, systemic embolism, or cardiac death in NVAF patients with a history of stroke or TIA?
Left atrial appendage occlusion using the LAmbre device appears safe and effective for preventing recurrent stroke in NVAF patients with a prior history of stroke or TIA.
Supports LAmbre safety and low stroke rate in high-risk NVAF; hypothesis-generating, requiring RCTs before adoption.
BACKGROUND: Patients with non-valvular atrial fibrillation (NVAF) and previous stroke have a significantly higher risk of stroke recurrence. This study aimed to examine the safety and efficacy of the LAmbre left atrial appendage occlusion device in NVAF patients with a history of stroke. METHODS: We examined 103 consecutive NVAF patients in 11 Chinese medical centers who had a history of stroke or transient ischemic attacks (TIA) and underwent placement of the LAmbre device. Follow-up was conducted 1, 3, 6, and 12 months after the procedure. The primary endpoints were the incidence of new ischemic or hemorrhagic stroke, TIA, systemic embolism, or cardiac death. Secondary endpoints were serious perioperative or device-related complications and cerebral, gastrointestinal, or other bleeding events requiring transfusion of at least 2 units of packed red blood cells. RESULTS: Mean patient age was 67.63 ± 7.14 years; mean CHA2DS2-VASc score was 4.72 ± 1.18 and mean HAS-BLED score was 1.90 ± 1.00. LAmbre device placement was successful in 101 patients (98.05%). Mean follow-up was 12.2 months. Five patients (4.95%) developed a new pericardial effusion after the procedure; none required treatment. Eighty-six patients (85.15%) exhibited no peri-device leak (PDL). However, 13 (12.8%) had a small (0-3 mm) PDL and two (2.3%) had a moderate PDL (3-5 mm). One recurrent stroke occurred during follow-up (1.1%). No other complications occurred. CONCLUSIONS: This multicenter study shows the safety and efficacy of LAmbre left atrial appendage occlusion for NVAF patients with a history of stroke or TIA.
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Bangash et al. (2023) studied this question.
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