What is the clinical evidence from this study?

Study design: Observational. Population: Atrial fibrillation and left atrial appendage thrombus (n=7). Intervention: LAmbre device for left atrial appendage closure. Primary outcome: Procedural success and occurrence of thromboembolic or bleeding events.

November 24, 2022Frontiers in Cardiovascular MedicineOpen Access

Percutaneous left atrial appendage closure using the LAmbre device in patients with atrial fibrillation and left atrial appendage thrombus

Q: What does this research mean for the field?

Left atrial appendage closure with the LAmbre device is safe and effective for preventing thromboembolic events in highly selected patients with atrial fibrillation and persistent left atrial appendage thrombus despite adequate anticoagulation. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

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Key result

Left atrial appendage closure with the LAmbre device was successfully performed in all 7 patients with persistent thrombus, with no thromboembolic or bleeding events during a median 383-day follow-up.

Why the study?

Data on left atrial appendage closure using the LAmbre device for patients with persistent left atrial appendage thrombus despite adequate anticoagulation remain limited.

Does modified percutaneous left atrial appendage closure using the LAmbre device prevent thromboembolic events safely in patients with atrial fibrillation and persistent left atrial appendage thrombus?

Study Design

Type

Observational (n=7)

Multicenter

Structured PICO

Population

7 male patients (median age 71) with atrial fibrillation and persistent left atrial appendage thrombus despite adequate anticoagulation, followed for a median of 383 days.

Intervention

Modified percutaneous left atrial appendage closure (LAAC) using the LAmbre device.

Outcome

Device-related thrombosis and peridevice leak at 3 months postoperatively, and clinical events (thromboembolic or bleeding) during perioperative and follow-up periodssafety

Modified LAAC using the LAmbre device appears feasible and safe in highly selected patients with AF and persistent LAA thrombus when performed by experienced operators.

Limitations

Single-center retrospective study with a small sample size
Patients were highly selected and operators were experienced, limiting generalizability
Silent brain ischemia and subclinical microembolization could not be excluded
Anticoagulation therapy after LAAC was not identical in patients
Relatively short follow-up duration
single-center retrospective study with a small sample size
highly selected patients and experienced operators limit generalizability
lack of brain magnetic resonance imaging and neurologic assessment to exclude silent brain ischemia
anticoagulation therapy after LAAC was not identical in patients
relatively short follow-up duration

Implication

May be feasible in selected refractory cases by experts; leaves open need for controlled trials before wider use.

Abstract

Background: Left atrial appendage closure (LAAC) is considered a valid alternative for the prevention of thromboembolic stroke in patients with persistent left atrial appendage thrombus (LAAT) despite adequate anticoagulation. However, the data on LAAC using the LAmbre device for patients with LAAT is limited. This study was performed to explore efficacy and safety as well as to share the experience of the modified LAAC procedure with the LAmbre device. Materials and methods: A total of 7 patients with persistent LAAT despite adequate anticoagulation underwent modified LAAC with the LAmbre device between November 2019 and April 2022. Transesophageal echocardiography was performed 3 months postoperatively to detect device-related thrombosis and peridevice leak. The patients' clinical events were evaluated during the perioperative and follow-up periods. Results: -VASc score, and HAS-BLED score of all patients were 71 [53-73], 3 [2-4], and 2 [2-3], respectively. In the procedure, a cerebral protection system was used in two patients. LAAC with the LAmbre device was successfully performed in all patients without perioperative events. During the median follow-up of 383 [325-865] days, postoperative transesophageal echocardiography was performed in six (85.7%) patients. Device-related thrombosis was detected in one (16.7%) patient, and no significant peridevice leak was observed. No thromboembolic event or bleeding event occurred in any patients. Conclusion: LAAC with the LAmbre device is effective and safe when performed by experienced operators in highly selected patients with LAAT after adequate anticoagulation.

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Published by Frontiers in Cardiovascular Medicine · CC BY

Cite This Study

Jin et al. (2022) conducted an observational in Atrial fibrillation and left atrial appendage thrombus (n=7). LAmbre device for left atrial appendage closure was evaluated on Procedural success and occurrence of thromboembolic or bleeding events. Left atrial appendage closure with the LAmbre device was successfully performed in all 7 patients with persistent thrombus, with no thromboembolic or bleeding events during a median 383-day follow-up.

synapsesocial.com/papers/6a23992e8ac8ec529b08ebca https://doi.org/10.3389/fcvm.2022.1071119